VOLUME: 18
PUBLICATION DATE: Oct 01 2010

EVEREST II Data Show Clinical Benefit From Mitral Valve Clip Device

A percutaneous mitral valve clip designed to stop mitral valve regurgitation demonstrated clinical benefit as measured by the degree of mitral regurgitation, according to a study presented at TCT. Mitral valve regurgitation is one of the most common forms of heart disease.

The study was led by James Hermiller, MD, Director of Cardiovascular Intervention at the St. Vincent Heart Center of Indiana (Indianapolis, IN).

“Significant measures of clinical benefit are observed one year following successful therapy,” said Dr. Hermiller.

The study, EVEREST II, is a prospective, multi-center, randomized controlled trial designed to compare the safety and effectiveness of the MitraClip System (Abbott Vascular, Redwood City, CA) with mitral valve surgery in the treatment of mitral regurgitation (MR). Measures of 12-month clinical benefit, defined as improvements in left ventricular (LV) function and symptomatic improvement, were evaluated for the Device Group and Control Group, and have been previously reported. But, observed clinical benefit by 12-month MR grade has not been reported.

Significant improvement in LV function, NYHA Functional Class, and Quality of Life scores was observed for all device patients with ongoing success (MR less than or equal to 2+ at 12 months). Patients with MR reduced to 1+, 1+ to 2+, or 2+ at 12 months demonstrated marked clinical benefit, with significant improvements noted from baseline to 12 months.

First-In-Human Study of Robotically-Helped PCI System Demonstrates Safety, Feasibility

The first-in-human study of a robotically-helped percutaneous coronary intervention (PCI) system, the CorPath 200 System (Corindus Vascular Robotics, Natick, MA), presented at TCT, demonstrated that the technique was safe and feasible. The current practice of PCI still presents multiple limitations and potential hazards for both the patient (radiation exposure, contrast media use) and the operator (spine strain, accumulated radiation). According to the study, robotically-helped PCI demonstrates the potential to decrease radiation exposure, contrast media usage, and improve technical precision.

The study was led by Juan F. Granada, MD, Executive Director and Chief Scientific Officer of The Jack H. Skirball Center for Cardiovascular Research at the Cardiovascular Research Foundation and Giora Weisz, MD, Director of Clinical Cardiovascular Research at the Center for Interventional Vascular Therapy (CIVT) at New York-Presbyterian Hospital/Columbia University Medical Center.
“Use of robotics is a very exciting development in interventional cardiology,” said Dr. Granada. “The operator is able to perform the procedure from a remote, radiation-protected control console. Initial experience with the use of this system demonstrated procedural effectiveness that was comparable to manual PCI.”

In the study, a total of eight patients were enrolled in a single-arm, open-mark, prospective study performed at the Corbic Research Institute (Corbic Institute, Envigado, Colombia). All patients had evidence of myocardial ischemia, documented de novo coronary stenosis, and clinical indication for PCI.
Using a remote system that is compatible and capable of advancing, retracting, and rotating 0.014” guidewires and rapid exchange catheter systems, the operator manipulates the interventional devices from a control console with joysticks while sitting comfortably at the radiation-shielded interventional cockpit.

The primary endpoint was technical success (

All patients met the safety and technical success endpoint criteria. The robotic system demonstrated a performance success of 97.8% in completing 48 procedural steps (47 out of 48). There were no instances of in-hospital or 30-day follow-up MACE or any other device or procedure-related adverse events. In 7 of the 8 cases, the operators consistently scored the robotic performance as equal to manual operation. Compared to published data, average contrast media use was lower (159 ml vs. 250 ml). The operator exposure to radiation was 97% lower than at the table position (1.8±1.9 µGy vs. 61.6±55 µGy, p

This initial trial will soon be followed by a multi-center U.S. study. The PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention Study) study, led by co-principal investigators, Drs. Giora Weisz and Joseph Carozza (St. Elizabeth, Boston), will aim to prove the safety and efficacy of the robotically-helped PCI system in a larger group of patients.

Xience V Stent Shows Continued Strong Performance in Key Safety and Efficacy Measures at Two Years in Investigator-Initiated COMPARE Trial

Data presented from the investigator-initiated COMPARE trial of 1,800 real-world patients involving Abbott’s Xience V^® Everolimus Eluting Coronary Stent System and the Boston Scientific Taxus^® Liberte^® Paclitaxel-Eluting Coronary Stent System. The results from COMPARE at two years were presented by Peter Smits, MD, of Maasstad Ziekenhuis, Rotterdam, the Netherlands, during TCT.

For the endpoint of major adverse cardiac events (MACE) at two years, which is a composite of all death, non-fatal heart attack (myocardial infarction or MI) and target vessel revascularization (TVR), Xience V showed a 34% lower incidence of MACE compared to Taxus (9.0% for Xience V vs. 13.7% for Taxus, p=0.0016). The composite secondary endpoint of cardiac death, non-fatal MI and target lesion revascularization (TLR) resulted in a 35% lower incidence for Xience V compared to Taxus (7.4% for Xience V vs. 11.4% for TAXUS, p=0.0038).

In addition, Xience V demonstrated a 77% lower rate of stent thrombosis, defined as certain or probable according to ARC (0.9% for Xience V vs. 3.9% for Taxus, p?0.0001); a 60% lower rate of TVR (3.1% for Xience V vs. 7.7% for Taxus, p?0.0001); a 56% lower rate of TLR (2.6% Xience V vs. 5.9% Taxus, p=0.0005); and a 49% lower rate of non-fatal MI (3.9% Xience V for vs. 7.6% for TAXUS, p=0.0009).

The stent thrombosis rate for Xience V between one and two years increased from 0.7% at one year to 0.9% at two years, while the Taxus arm increased from 2.6% at one year to 3.9% at two years. At two years, 88.6% of Xience V patients and 84.8% of Taxus patients had discontinued dual-antiplatelet therapy.

The COMPARE study is a physician-initiated “all-comers” trial sponsored by Maasstad Ziekenhuis of Rotterdam, the Netherlands. The study, designed to reflect real-world, everyday clinical practice, enrolled 1,800 patients in a single-center, prospective randomized (1:1) comparison of safety and efficacy of the Xience V stent to the Taxus Liberte stent. The COMPARE trial was supported in part by an Abbott grant. All aspects of the trial were designed and conducted independent of Abbott.

PARTNER Trial Establishes Catheter-Based Aortic Valve Replacement as New Standard of Care for Patients Who Cannot Undergo Surgery

One-year data from the PARTNER clinical trial, published in the New England Journal of Medicine, demonstrate that transcatheter aortic-valve implantation, compared with standard therapy, resulted in significantly lower rates of death among patients who cannot undergo surgery for aortic stenosis. The results were presented at TCT.

Transcatheter aortic-valve implantation (TAVI) is a new procedure in which a bioprosthetic valve is inserted through a catheter and implanted within the diseased native aortic valve. The Placement of AoRtic TraNscathetER valves (PARTNER) trial is a multicenter, randomized clinical trial comparing TAVI with standard therapy in high-risk patients with severe aortic stenosis. The co-principal investigators are Martin B. Leon, MD, and Craig R. Smith, MD, at NewYork-Presbyterian Hospital/Columbia University Medical Center. The data reflect a prespecified cohort of patients who were considered to be unsuitable candidates for surgery.

The primary endpoint was the rate of death from any cause over the duration of the study. A total of 358 patients with aortic stenosis who were considered to be unsuitable candidates for surgery underwent randomization at 21 centers, including 17 in the United States. Patients randomized for standard therapy received a combination of watchful waiting, medications, and balloon aortic valvuloplasty, which can provide transient clinical benefit, but does not alter long-term outcomes.
At one year, patients who underwent TAVI showed a 45% reduction in the rate of death from any cause compared with patients who received standard therapy (30.7% vs. 50.7%) and a 54% reduction in the combined endpoint of death from any cause or repeat hospitalization (42.5% with TAVI vs. 71.6% with standard therapy). Among survivors at one year, the rate of cardiac symptoms was significantly lower among patients who had undergone TAVI, as compared with those who had received standard therapy (25.2% vs. 58.0%).

“Based on the reduction in mortality during the first year of the study, balloon-expandable TAVI should be the new standard of care in patients who are not suitable candidates for surgery,” said Martin B. Leon, MD, professor of medicine and director of the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital and Columbia University Medical Center. Dr. Leon is the co-principal investigator of the study.

At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%) and major vascular complications (16.2% vs. 1.1%). In the year after TAVI, patients had no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram.

“This study shows that transcatheter valve replacement is a safe and effective option for this life-threatening illness in patients unsuitable for surgical valve replacement,” said Dr. Smith, study co-principal investigator and surgeon-in-chief at New York-Presbyterian Hospital/Columbia University Medical Center. “Additional studies are needed to examine the increased incidence of stroke following TAVI.”

According to the study authors, research is already underway on the next generation of TAVI devices that researchers hope will address the vascular complications encountered in the trial.
Aortic stenosis results in a poor quality of life and a high rate of death, approximately 50 percent, in the first two to three years after diagnosis without surgical intervention.

Approximately 300,000 Americans suffer from severe aortic stenosis.

In clinical practice, at least 30% of patients with severe symptomatic aortic stenosis do not undergo surgery for replacement of the aortic valve because of advanced age, left ventricular dysfunction, or the presence of multiple coexisting conditions.

The replacement valve used in the PARTNER trial is made of pericardial tissue leaflets hand-sewn onto a metal frame and implanted via a catheter into the left ventricle. It is then positioned inside the patient’s existing valve using a balloon to deploy the frame, which holds the valve replacement in place. The procedure is performed on a beating heart, without the need for cardiopulmonary bypass and its associated risks.

The transcatheter valve procedure takes about 90 minutes, compared with four to six hours for open-heart surgery. In open-heart surgery, the surgeon cuts through the breastbone, stops the heart, removes the valve, and replaces it. Open-heart surgery can require a two- to three-month recovery period, compared with only a few days for the transcatheter approach.
The multi-center PARTNER trial, which has more than 1,000 patients, started in 2007 and will be completed in 2014. The results reported at TCT reflect only the cohort of patients who are not considered candidates for surgery. The other arm of the trial, which compares transcatheter valves with surgically implanted valves, is ongoing. The executive committee of the trial includes two academic co-principal investigators, three interventional cardiologists, and three cardiac surgeons.

SCAI Statement on the PARTNER Trial Results

New data published in The New England Journal of Medicine show encouraging results for minimally invasive transcatheter aortic-valve implantation (TAVI) in patients with severe aortic stenosis who are too high risk to undergo surgery. While TAVI is approved for treatment of aortic stenosis in other countries, it is currently experimental in the U.S. These results are preliminary and more research is needed, but they are undoubtedly vital in laying the groundwork for providing new and effective minimally invasive treatments to patients with severe disease.

Aortic valve stenosis, a common heart problem in older adults, can cause shortness of breath, chest discomfort with exercise or fainting spells. Aortic stenosis worsens over time and requires open-heart surgery to replace the diseased heart valve. The rate of aortic valve replacement increases as patients get older. Unfortunately, the risk for open heart surgery generally increases for older patients. Left untreated, the disease can quickly result in death.

The Placement of Aortic Transcatheter Valves (PARTNER) trial, a multi-center, randomized clinical trial comparing TAVI with standard therapy (typically balloon aortic valvuloplasty) in high-risk patients with severe aortic stenosis, showed:

• TAVI was superior to standard therapy, markedly reducing death after one year (the primary endpoint of the study).

• TAVI significantly reduced the rates of death from cardiovascular causes and repeat hospitalization.

• TAVI was associated with a significant reduction in symptoms, but was also associated with more neurological events (including strokes), major vascular complications, and major bleeding events as compared to the standard therapy group.

“Without exciting, new minimally invasive treatment options like TAVI, people with severe aortic stenosis will continue to have few to no treatment options and will die from their disease,” said Christopher White, MD, FSCAI, chairman, department of cardiology, and director of the Ochsner Heart Vascular Institute, Ochsner Medical Center in New Orleans, and president-elect of the Society for Cardiovascular Angiography and Interventions. “These results are very encouraging and suggest TAVI is an effective treatment option for severe aortic stenosis in patients who cannot have surgery.”

Abiomed Reports Updated USpella Registry Data

Abiomed Inc. announced updated clinical data from USpella, a U.S. multi-center, observational registry of Impella 2.5^® patients. The new updates, presented at TCT 2010, reported that 24 U.S. and Canadian centers have contributed data for a total of 352 patients. The USpella registry results were last announced on May 15, 2010 at EuroPCR 2010.

The updated USpella results were presented by William O’Neill, MD, University of Miami Miller School of Medicine, and Brijeshwar Maini, MD, Pinnacle Health and Vascular Institute.
The updated USpella registry^* reported the following:

After prophylactic Impella supported revascularization:

• Significant (17%) improvement of left ventricular ejection fraction (LVEF)

• Significant improvement (49% of patients) in New York Heart Association (NYHA) class with 61% reduction in NYHA class four

• Significant (25%) reduction in implantable cardiac defibrillator (ICD) target population, leading to potential cost savings

• More than half of the patients (54%) were turned down for coronary artery bypass graft surgery (CABG), 59% of the patients had experienced a prior myocardial infarction (MI)

• Low mortality (3.9%) and major adverse cardiac events (MACE) event rate (8.2%) in patients, compared to high-risk PCI literature^**

After emergent Impella support:

• Hemodynamic support with the Impella 2.5 (cardiac index, cardiac power output, wedge pressure, mean arterial pressure) significantly increased over the intra-aortic balloon pump (IABP) in this study

• Impella improves cardiac power output (CPO), the strongest correlate of in-hospital mortality (CPO increased from 0.5 +0.2 before Impella support to 1.0 + 0.2 after Impella support)

• Significant (19%) improvement of LVEF at discharge

• Significant reduction (59%) in mortality in the group that received Impella before PCI

• Ninety percent of the survivors recovered native cardiac function and were discharged with their own hearts

^*Significant = statistically significant with p
^**Syed Al, et al. Cardiovasc Revasc Med 2010; 1191–1197.

Fully Bioresorbable Vascular Scaffold Technology Shows Positive Data at Six and Nine Months

Abbott announced positive nine-month results from the first 45 patients enrolled in the second stage of the ABSORB trial. At nine months, Abbott’s bioresorbable vascular scaffold (BVS) demonstrated strong results that remained consistent with the six-month data from the same 45-patient group, with the rate of major adverse cardiac events (MACE) unchanged at 4.4 percent and no reports of blood clots (thromboses). These results were presented during the TCT.

“I am impressed with how consistent the BVS data have been to date, as the nine-month data are compelling and supportive of earlier positive results,” said John Ormiston, MD, medical director at Mercy Hospital in Auckland, New Zealand, and co-principal investigator for the ABSORB trial. “In addition to the positive safety data we’ve seen to date, the late loss rate of 0.19 millimeters reported at six months is comparable to a metallic drug-eluting stent, and may address a limitation of metal stents by not leaving metal in the artery.”

Abbott also presented six-month results for all 101 patients enrolled in the second stage of the ABSORB trial. In this complete patient population, the MACE rate remained consistent, with a nominal increase from 4.4% at six months in the first 45 patients to 5.0% at six months in all 101 patients. There were no reports of blood clots in any of the 101 patients.

Patrick W. Serruys, MD, PhD, professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator for the ABSORB trial, said, “The findings to date show that the device appears to effectively treat coronary artery disease with the possibility of restoring natural vessel function in a way that is not possible with permanent implants.”

Abbott’s BVS is under investigation in two clinical studies, ABSORB and ABSORB EXTEND, and is currently not available for sale anywhere in the world. The BVS is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as resorbable sutures.

The ABSORB trial is a prospective, non-randomized (open mark), two-phase study that enrolled 131 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety — MACE and treated-site thrombosis rates — at 30 days; six, nine, 12 and 24 months; with additional annual clinical follow up for up to five years, as well as an assessment of the acute performance of the bioresorbable vascular scaffold, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six, 12, 18, 24 and 36 months.

The ABSORB EXTEND trial is a single-arm study that is currently enrolling patients at up to 100 centers in Europe, Asia Pacific, Canada and Latin America. The trial will enroll approximately 1,000 patients, including patients with more complex coronary artery disease. Abbott’s bioresorbable technology delivers everolimus, an anti-proliferative drug.

Economic Model Suggests That the Use of Cypher in Diabetic Patients May Result in Substantial Cost Savings When Compared to Other DES

New analysis indicates that the broad use of Cypher^® sirolimus-eluting coronary stent in patients with diabetes would result in substantial cost savings, as compared to the use of everolimus-eluting stents (EES), paclitaxel-eluting stents (PES), or zotarolimus-eluting stents (ZES). According to this analysis, the cost reduction per diabetic patient treated with Cypher would range between $733 and $937, depending on the comparator drug-eluting stent (DES). When this analysis is extrapolated to an estimated 200,000 U.S. diabetics that undergo percutaneous coronary intervention (PCI) with DES implantation each year, the annual cost savings with Cypher would exceed $145 million vs. all three other DES (EES, PES, or ZES).

This study reflects the growing attention to Comparative Effectiveness Research, a focal issue in the recent health care reform debate. “This study adds to the large body of evidence assessing the economic value of drug-eluting stents,” said Ryan Saadi, MD, MPH, Worldwide Vice President of Health Economics and Strategic Pricing at Cordis. “It is unique in that it includes all relevant stents and predicts the actual costs for an entire population of patients, in this case diabetic patients that qualify under a fixed fee reimbursement system like Medicare. We look forward to presenting our analysis in other vital patient sub-groups in the future.”

The analysis was based on the rates of target lesion revascularization (TLR) at 1 year among 4,853 patients with diabetes in 13 head-to-head clinical trials of various DES, all of which included the PES. When outcomes from these trials are combined using an indirect comparisons framework, the rate of TLR at 1 year in diabetic patients treated with PES was estimated to be 6.9%. The use of either EES or ZES was not associated with a significant relative risk reduction in 1-year TLR vs. PES. The 1-year TLR rates were estimated to be 7.9% for EES and 7.1% for ZES). In contrast, the use of Cypher led to a highly significant, 54% relative risk reduction in the rate of 1-year TLR (3.2%) vs. the PES (p

Note: Neither the Cypher stent nor any other DES sold in the U.S. has an FDA-approved indication for use in patients with diabetes.

Novel Drug-Eluting Stent System for Treatment of Small Vessels Demonstrated Safe and Effective at Eight Months

Biosensors International Group, Ltd announced 8-month results from the CARE II Study, which showed that its novel Sparrow^® drug-eluting stent system, developed by recently-bought CardioMind, Inc., is both safe and effective in the treatment of small-vessel lesions. These results were presented by the Principal Investigator, Dr. Alexandre Abizaid, Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil, at the TCT.

The Sparrow drug-eluting stent system combines a limus drug in a fully biodegradable polymer matrix with a self-expanding ultra-thin nitinol stent, mounted within a 0.014-inch guide wire delivery system. Due to its “stent-on-the-wire” construction, Sparrow has been developed as 60% smaller than the nearest available coronary stent system. Stent deployment is achieved through a novel release mechanism that utilizes electrochemical dissolution.

The CARE II trial included 138 patients with single de novo native coronary artery lesions with a diameters between 2.00 mm and 2.75 mm and lengths up to 20 mm, randomized to receive either the Sparrow limus-eluting stent (DES), Sparrow bare-metal stent equivalent (BMS), or the established MicroDriver^® BMS designed for small vessel use. The trial’s primary endpoint was in-stent late loss at eight months.

Average in-stent late loss in patients treated with the Sparrow DES was 0.29 mm, compared with 0.86 mm in patients treated with the Sparrow BMS, and 0.99 mm in patients treated with the MicroDriver. The difference was statistically significant in both cases (Sparrow DES vs. Sparrow BMS: p=0.0001; Sparrow DES vs. MicroDriver: p

In a CARE II sub-study presented separately at TCT by Dr. Teruyoshi Kume, Stanford University Medical Center, intravascular ultrasound (IVUS) was performed on 74 patients (31 receiving the Sparrow DES; 22 receiving the Sparrow BMS and 21 receiving the MicroDriver). Average stent volume index increased 15% in the Sparrow DES-treated patient group and 9% in the Sparrow BMS-treated patient group, compared with a 1% decrease in the MicroDriver-treated group. The difference between the Sparrow DES and MicroDriver was statistically significant (p
“The CARE II eight-month results demonstrate the efficacy and safety of the Sparrow drug-eluting stent system in small coronary arteries, and suggest that its guide wire-like delivery mechanism and less traumatic stent expansion characteristic may improve outcomes in small vessels,” commented Dr. Abizaid.

Zilver^® PTX^® DES Meets Its Primary Endpoint in a 479-Patient, Multi-Center, Pivotal Clinical Trial

A summary of the final clinical trial results for the randomized study of Cook Medical’s Zilver^® PTX^® drug-eluting peripheral stent for use in patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA) was presented at TCT. The study — from the largest clinical trial to ever evaluate the performance of a drug-eluting stent (DES) in the treatment of peripheral vascular disease — met its 12-month primary endpoint goals showing non-inferior event-free survival (EFS) and superior patency for the Zilver PTX as compared to balloon angioplasty. Cook Medical has developed Zilver PTX: a self-expanding, highly durable nitinol stent that uses a proprietary technology to deliver a locally therapeutic dose of paclitaxel to the target lesion. The data from this clinical trial supports Cook’s PMA application submitted to the FDA earlier this year.

This multicenter, multinational, prospective, randomized study compared the safety and effectiveness of the Zilver PTX to balloon angioplasty and bare metal stenting. Patients with de novo or restenotic SFA lesions were randomized to balloon angioplasty or Zilver PTX stent placement. Balloon angioplasty patients experiencing acute failure (30% residual stenosis) underwent secondary randomization to provisional stenting with Zilver BMS (bare metal stent) or Zilver PTX. Endpoints included event-free survival, stent integrity by radiographic core laboratory analysis, and primary patency by Duplex ultrasound core laboratory analysis (peak systolic velocity ratio 55 institutions in the United States, Japan and Germany), with 241 patients randomized to the Zilver PTX group and 238 to the balloon angioplasty group. Demographics and lesion characteristics were similar for both groups. Approximately half the balloon angioplasty group experienced acute failure and underwent secondary randomization, assigning 59 and 61 patients to provisional stenting with Zilver BMS and Zilver PTX, respectively.

The study met its 12-month primary endpoint by showing non-inferior event-free survival and superior patency for the Zilver PTX compared to balloon angioplasty. There was also significant clinical improvement in the group receiving Zilver PTX.

The Zilver PTX stent was CE Marked in August 2009 and has been made available in Europe since September of 2009. In the United States, the Zilver PTX DES is an investigational device not available for sale at this time.

Early Transcatheter Valve Recipient Honored With Courageous Patient Award At TCT 2010

Lillian Feldshuh, of Scarsdale, NY, an early recipient of a transcatheter aortic valve in 2006, received the Courageous Patient Award at the Transcatheter Cardiovascular Therapeutics (TCT 2010) scientific symposium in Washington, DC. The procedure was a success and Feldshuh, who will turn 100 years in just 7 months, remains in good health.

In 2006, Lillian Feldshuh suffered from aortic stenosis. Even though she had been told there were no options, the team at NewYork-Presbyterian Hospital/Columbia University Medical Center, led by Dr. Martin B. Leon, performed percutaneous aortic valve replacement on the then 95-year-ancient woman. On September 23rd, that team presented her with the award.

Mrs. Feldshuh was accompanied to Washington by her children, Broadway actress Tovah Feldshuh and playwright and physician David Feldshuh. She delivered her acceptance remarks to an audience of over 3,000 physicians.

“In June 2006, I was given the choice to die or take the chance to live. Naturally, I chose to take the chance to live. Maybe I’m a pioneer, I don’t know. But I accept this award with gratitude and wonder. Who could have predicted in 1911 that in my hundredth year I would be receiving an award from the finest doctors in the world? I’ve had a blessed life. To reach this time and these years and be with you today, life is wonderful. I thank you from the bottom of my heart,” Feldshuh said.

Article source: http://www.cathlabdigest.com/articles/News-22nd-Annual-Transcatheter-Cardiovascular-Therapeutics-TCT-Scientific-Symposium

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VOLUME: 18
PUBLICATION DATE: Oct 01 2010

We recently were performing a right heart catheterization on a patient. Our policy is that all patients get oxygen during their procedure. We had a debate about whether we should do this for the right heart cath part.
– Orlando, Florida Cath Lab Team Member

I have seen where “prophylactic” administration of oxygen during catheterization procedures occurs. This varies from facility to facility across the country. The usage of oxygen in this manner is completely up to the facility, and there is really nothing evidenced-based that is for or against this practice. It can be part of plotting and being prepared. But, oxygen should NEVER be withheld from a patient that needs it.

When performing certain right heart catheterization procedures, the use of oxygen CAN cause erroneous data. For a simple right heart catheterization, when only pressures are being monitored, the use of oxygen is inconsequential. It’s when procedures involving oxygen saturations are being performed that oxygen administration can skew results. Obtaining saturations for the Fick Method of cardiac output calculation or analysis of shunts can be erroneous if supplemental oxygen is administered.
For proper use of the Fick Method, the patient must be breathing room air during blood sample collection.¹ Supplemental oxygen therapy should be discontinued at least 10 to 15 minutes before determination of the cardiac output by the Fick Method. If oxygen cannot be discontinued safely, an alternative to the Fick Method should be used.²

More importantly, to reduce chances of error, a steady state (where cardiac output and oxygen consumption are constant during drawing of samples) should be present.³ This means that the patient should be kept cool and relaxed during the procedure. Over-sedation that results in less than optimal respirations/ventilations would also affect the oximetry results.

With that being said, the choice for administration of oxygen during the procedure comes from the clinical judgment of the physician, and again, never withhold oxygen from a patient that needs it.

Email your question to Todd Ginapp at tginapp@rcisreview.com

References

1. Libby P, Bonow RO, Mann DL, Zipes DP. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 8th Edition. Philadelphia: Elsevier Science; 2007.

2. Kern MJ. The Cardiac Catheterization Handbook. 4th ed. Philadelphia, Penn.: Mosby; 2003.

3. Baim DS, ed. Grossman’s Cardiac Catheterization, Angiography, and Intervention. 7th ed. New York, NY: Lippincott Williams Wilkins; 2006.

Article source: http://www.cathlabdigest.com/articles/Ask-Clinical-Instructor-QA-Column-Those-New-Cath-Lab

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VOLUME: 18
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Does your physician do any peripherals through the radial artery?

Yes, we do some peripherals on selected patients through the left radial, because it is a shorter distance from the left as compared to the right. We performed a case from the left radial using the CSI Diamondback 360? PAD system (Cardiovascular Systems Inc., St. Paul, Minn.), an orbital atherectomy device. Heparin was administered. We advanced a Viper wire (Cardiovascular Systems) distally into the right superficial femoral artery (SFA) and then performed orbital atherectomy of the ostium of the iliac artery with a 2 mm crown. There was approximately 2 minutes of run time with the orbital atherectomy device. Following orbital atherectomy, we predilated with a 6.0 x 20 mm balloon. There was a small dissection noted and therefore we placed a 8.0 x 29 mm Genesis stent (Cordis Vascular, Warren, New Jersey) to the ostium of the iliac artery. Final angiography was then performed with a pigtail in the distal aorta and a runoff of 10 for 30 at 600 psi, revealing that there was 0% residual stenosis. The ostium of the iliac was patent, as was the ostium of the left iliac, with no plaque shift. The sheath was withdrawn and a TR Band (Terumo Medical Corp., Somerset, New Jersey) was placed over the radial artery.

Using the Diamondback 2.0 crown, we were able to change the compliance of the vessels to accommodate the 8.0 by 29.0 mm Genesis stent. Here are some of the reasons why we choose to use the Diamondback 360:

• Sands noncompliant, calcified and fibrotic tissue.
• Allows the more elastic media layer to flex away from crown.
• Reduces or eliminates barotrauma, unlike balloon angioplasty alone.
• Changes compliance if adjunctive percutaneous transluminal angioplasty is needed: fewer atms needed means less barotrauma and fewer dissections.

Email your question to: orlando.marrero@winterhavenhospital.org

Article source: http://www.cathlabdigest.com/articles/QA-Cath-Labs-Physicians-Performing-Radial-Access-3

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Many hospitals across the country are facing the same or similar challenges: the need to reduce expenses and/or pressure to enhance revenue. Initiatives to achieve these and other more detailed financial goals affect all levels of the organization, and the impact can often be felt all the way from the administrative suite to the staff directly involved with patient care.

Some of the largest money-generating service lines include the cardiovascular and neuroscience specialties. Procedures in these areas have not only fantastic revenue potential, but also fantastic volume potential as well, which is why such attention and scrutiny is focused here — mostly in terms of operational efficiency, quality, and cost.

Indeed, these specialties are often the only ones where growth opportunities are still prevalent in many markets. Cardiac, vascular, and neuro conditions are on the rise, and in some areas of the country, many communities remain underserved. If services in these specialties both at a programmatic and patient-care level are well-coordinated, then it is typically a win-win for the hospital and the community.

From the perspective of hospitals, regulatory agencies, and insurance providers, the delivery of care in these specialties is becoming less restrictive, though payment(s) for the care that is provided is being tightened. And, due to industry-wide financial pressures, including recent changes to MS-DRGs and restricted access to capital, all hospital team members need to know how money is generated for the hospital and/or for the program.
At Corazon, we work diligently to remain on the forefront of the ever-changing healthcare industry. One area of focus is vigorous research and analysis of Medicare’s reimbursement rates for cardiovascular and neurosciences for both the proposed and final rulings.

This year, there is good news in the immediate future! Final rates for fiscal year 2011 (which go into effect October 1, 2010) reveal some positive changes. In general, there are more notable payment increases in MS-DRGs grouped using the descriptors “with or without Complications and Comorbidities.” Therefore, if procedures are accurately documented/coded in the patient record, then the payments received will more adequately compensate the hospital for the cost of services, including staffing.

Further, the outlook is favorable for certain specialties such as cardiac and neuro. While the Medicare IPPS overall base rate (calculated by combining the labor, non-labor, and capital rates) is expected to decline by 1.2% in fiscal year 2011, Corazon observes that reimbursement for the cardiovascular and neuroscience service lines is increasing. Indeed, the rates for fiscal year 2011 reveal some positive findings in these key subspecialties. This is the result of relative weights — assigned to specific DRGs in cardiac and neuro — which are increasing from the previous year, up 1.9% across the Major Diagnostic Category 5 (MDC 5) [or the entire grouping of Cardiovascular (CV) DRGs]. This can be further delineated within the MDC-5 classification to reveal a 2.0% increase across CV surgical DRGs, and a 1.7% increase across CV medical DRGs.

The neurosciences relative weight values are following a similar course. The neurosciences DRG relative weights in MDC-1 are increasing 2.2% overall, with a 2.2% increase in the neurosurgical DRGs and a 2.6% increase within the neuromedicine DRGs.

Corazon’s relative weight analysis is illustrated in the charts below. It should be noted that the medical CV DRGs, which typically include diagnoses such as syncope or angina, is the only category to show a decreased relative weight value of 1.4%. It should be noted that this decrease for the medical DRGs only appears significant if three full years of retrospective data is analyzed to include fiscal year 2009. There was an increase of 1.7% in the medical DRGs from fiscal year 2010 to fiscal year 2011 (Table 1).

For those readers unfamiliar with the IPPS reimbursement structure, the relative weights per DRG are multiplied against the CMS overall [standard] base rate to achieve the payment rate for that particular DRG being examined.

For example, the relative weight forecasted for DRG 287 (Diagnostic Catheterization wo MCC) is 1.0879, and this value has increased 5.4% from the following year. This relative weight multiplied against the base rate of $5,584.12, which assumes that the hospital has reported all quality measures for the previous year, equates to a reimbursement of $6,074.71. This example represents a payment increase of 4.1%, resulting in a much brighter financial forecast for the inpatient diagnostic cath patient population in this example.

The financial forecast does not have as “sunny” an outlook from the Outpatient Payment Prospective System (OPPS) perspective, which was proposed in July and will be finalized in November. This can be a cause for concern, especially as procedures that have been traditionally treated and billed as inpatient continue to trend more towards outpatient status. The Ambulatory Payment Categories (APCs) experiencing the most negative impact with the new rulings include echocardiograms (APCs 0126 and 0269), which will experience a 13% to 25% reimbursement decline. Outpatient coronary stent placement, and pacemaker, lead, and generator procedures are also experiencing some decline in payment, though not as remarkable as with echo procedures.

Table 2 summarizes the more common procedural cardiovascular DRG and APC reimbursement trends from 2009 final to 2011 final and proposed rates, and their respective two-year and three-year percent changes. The majority of open heart surgery DRGs, inclusive of bypass and valve procedures, are proposed to increase 0.6% to 3.4%, with exception of DRGs 216 218 (valve procedure with MCC and without MCC/CC), which will decline 2.9% and 0.3%, respectively.

Fascinatingly, inpatient interventional and diagnostic catheterization procedures are experiencing an increase between 0.7% – 12.8%. The outpatient APCs for cath and PCI do not look so favorable, but it should be noted that the APC rates provided in the table do not include the reimbursement of other APC codes that may be billed in the same setting of care. Also, the outpatient rates listed are proposed and are subject to change in the final rulings, which have not been released at the time of this writing.

Other changes expected for both prospective payment systems include updates with various revisions to their respective quality measures. For this year, an additional 12 IPPS measures were added and one mortality measure was retired. Meanwhile, a total of 17 new measures are proposed for the OPPS. Additional quality measures were also proposed for reporting in 2012 and 2013 for the prior year’s reimbursement calculation. Reporting outcomes on all quality measures further ensures that your organization will achieve the full base rate payment in the following year, maximizing Medicare reimbursement(s).

Corazon recommends that all hospitals track quality consistently and appropriately, and report measures as required in order to ensure that full reimbursement potential is achieved.

Regarding the recently enacted Patient Protection and Affordable Care Act (ACA), the proposed IPPS does not fully address the hospital-related provisions that will be required. We advise keen administrators to stay alert and attuned for future changes, and how they will impact the bottom line. ACA updates included in the OPPS are aimed at functions such as waiving co-pays for the majority of Medicare-covered preventive services, as well as factoring in an 0.25% reduction in the proposed rates; this decline is reflected in Table 2’s outpatient APC rates.

Where we see potential reimbursement storms is within the Medicare Physician Fee Schedule, or MPFS. For proposed 2011, MPFS reimbursements estimates are not available due to CMS uncertainty with the sustainable growth rate (SGR) formula. This controversy related to the SGR in determining physician payment is nothing new. But, the newly-proposed rule will require CMS to utilize a SGR that will cut payment rates for physician services by 27%. This 27% is a combination of the 21.2% cut implemented for 2010, but delayed until December 2010, along with a 6.1% cut proposed for 2011.

This difficulty with financial forecasting has caused Corazon to receive many inquiries from both hospital administrators and physicians. These parties are now looking for education and help with potential partnership developments in order to provide a sustainable patient practice model and revenue stream.
Another impact of this change is that physicians are now looking once again at employment opportunities, as well as joint venture and co-management models within the cardiovascular and neuro service lines. Several of these partnership structures will equate to the hospital and physicians sharing the technical fee, which may be hard to do given the dollar constraints facing hospital and physician providers in today’s economy. The financial projections for some of these models can be highly variable, because each model is dependent on the investment that is required to “seed” the structure and success with the maximization of revenue and cost savings.

In our experience, models that succeed have engaged physicians with an understanding of the revenue cycle. And, these same physicians are intimately involved in the day-to-day operations, having a close eye on quality of care and efficiency of operations. We believe organizations should incorporate partnering opportunities into their strategic plotting process, as well as investigate further whether a certain partnering model is an organizational fit.

The final rulings will go into effect October 1st, 2010, for the IPPS and January 1st, 2011, for OPPS. Savvy hospitals should always be looking at the reimbursement for the cardiovascular and neuroscience service lines, as changes to these specialties can have a big impact on the bottom line.
To ensure that the financial health of your organization remains viable, especially with many positive rate changes on the horizon, we recommend:

• Accurate cost tracking
• Refined supply and device management processes
• Sound supply and device usage criteria
• Appropriate management of employee costs
• Regular updating of cost reports
• Accurate coding and documentation

Overall, we advise that all organizations regularly analyze expected Medicare reimbursement using anticipated procedural trends, as well as predicted payments from other top payers. For example, in most markets, Medicare volume accounts for nearly 51% of the volume to the cardiovascular service line. Understanding the additional 49% can be critical to an organization’s success. Factoring this information into the budgeting process and monitoring expense will help secure profitability and more accurate budgeting.

Further, knowing what accounts for any difference in “expected” versus “actual” reimbursements, denial write-offs, and unpaid balances, can lead to some fascinating findings that can give valuable insight into the financial health of your cardiovascular and neuro service lines, and perhaps, the hospital as a whole.

Nicole is a consultant with Corazon, offering consulting, recruitment, and interim management for the heart, vascular, and neuro specialties. To learn more, visit www.corazoninc.com.

To reach Nicole, email her at: nmckenna@corazoninc.com

Article source: http://www.cathlabdigest.com/articles/2011-Financial-Forecast-Understanding-Cardiovascular-Neuroscience-Reimbursement

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VOLUME: 18
PUBLICATION DATE: Oct 01 2010

Nearly 10 years ago, Cath Lab Digest’s September 2001 issue included the article, “The Process of Developing Competencies for Cath Lab Skills: “To perc, or not to perc; that is the question…” by Gerald Lagasse, available online at http://tinyurl.com/PercStick. After being questioned for an update by a reader, Gerry shares current-day access policies at Borgess Medical Center.

1) Staff member has to pass a written test with questions derived from Grossman’s Cardiac Catheterization, Angiography, and Intervention (D. Baim, ed., published by Lippincott Williams Wilkins), Invasive Cardiology: Manual for Cath Lab Personnel (S. Watson, K. Gorski, published by Jones and Bartlett Learning), or other reliable sources.

2) Staff member, after passing the test, then performs sixty (60) arterial accesses under the supervision of a proctor. (This number was determined by the director, chief of cardiology and senior staff personnel).

3) Staff member then takes the “perc stick” test. The test is as follows:

Staff member must have a minimum of 15 arterial acquisitions on the first pass. Maximum of three (3) attempts on one patient is all that is permissible. Three (3) patients with three (3) attempts means the staff member fails the test. A person can have 15 single acquisitions and 5 double acquisitions, and pass. A person can have 15 single, three double, and two triple acquisitions, and pass. The purpose of the test is to show a staff member’s ability to safely access an artery and also know when not to attempt access. The staff member is permitted to determine on which patients he/she will attempt to test. In the beginning, when we first set the test up, we would have the first twenty patients in the room as the twenty patients for the test. The staff failed miserably and said it couldn’t be done. I took the next senior staff member and myself, and we showed them that it could be done. But I realized that I had years of experience and they had none. I then decided to let the staff choose which patients would be included on their tests. They then question the patient pertinent questions (“What’s that scar down here?,” “Do you have problems walking? Which leg?” and so on) and palpate the pulse. They become comfortable with the artery. Staff then turns to the tester and state if the patient is a candidate for the test. If the patient is not a candidate, they can still make an attempt (if the patient is appropriate), but had to stop at three. This is a good way for the testee to develop greater confidence in their clinical abilities and possibly in their access skills.

The femoral head has become an vital indicator for complication rates. For the last few years, we have also required that all access attempts be made after determining the location of the femoral head. Access of the artery over the femoral head greatly improves the success of hemostasis after the procedure.

Here is how we do it:

Turn on fluoro and position a hemostat directly over the femoral head. The position of the tip of the hemostat becomes your bull’s eye area. Reposition patient away from II tube, remove hemostat and give local anesthetic to the area. Gently massaging the area after the anesthetic has been given allows for greater absorption into the area, diminishes volume size over the artery, and allows for simpler palpation of the pulse. Allow sufficient time for the local to make the area pain-free and then perform the access. Once the sheath is in place, rotate the C-arm 30 degrees LAO and RAO, and fluoro record an injection of dye, visualizing the femoral head, femoral artery and access point of the sheath into the artery.

Results are marked on a femoral access sheath in the back of the lab, along with the number of attempts in the cath data record. The femoral sheath has the patient name, person performing access, and location of access (high, low and optimum). Not only does this allow vital information to be passed on to the floor nurse who will be removing the sheath, but it is also used for tracking complications. Complications from the cath lab can include retroperitoneal bleed due to access above the femoral head or hematoma due to access below the femoral head. If complications do occur, and records show minimal perc stick attempts and appropriate sheath placement, then other sources of potential problems can be followed and resolved. Recording sheath site access can also be used to determine if a closure device is appropriate for the patient.

Article source: http://www.cathlabdigest.com/articles/Sheath-Insertion-Procedures-Protocols-Cath-Lab-Staff

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VOLUME: 18
PUBLICATION DATE: Oct 01 2010

There are many tests and procedures in medicine, and specifically in cardiology, that require patients to take nothing by mouth (NPO) for several hours before the procedure. NPO has been the standard of care for cardiac cath since its inception, because of the associated vomiting that was common with the first generation of radio contrast materials that were almost toxic. But, over the decades, the contrast media and the cath procedure itself have become very safe. It is rare to have a patient undergo a diagnostic cath with an adverse event like vomiting, hypotension (contrast-related) or arrhythmia [right coronary artery (RCA)-induced ventricular tachycardia (VT) or heart block] when using any of the modern contrast media used today. But, the pre-procedure orders for cardiac cath still state, “NPO after midnight.” Should this remain our practice?

“Let the patient eat,” said Dr. John Bittl from Ocala, Florida, when questioned about his pre-cath routine.

He continued, “It’s time to eliminate the NPO order before invasive and interventional procedures, because 1) there is no hydration protocol that maintains euvolemia better than the homeostatic mechanisms of the body; 2) there is no compelling evidence that fasting makes PSA (procedural sedation and anesthesia, also called “conscious sedation”) safer; and 3) there is only about a 0.1% risk of needing emergency surgery for percutaneous coronary interventions (PCIs). In our program, for the past 13 years, we have not required patients to quick. We do not decrease insulin doses. We have avoided intravascular volume depletion, hyperglycemia (which may contribute to acute kidney injury with contrast), and osmotic diuresis. We have decreased the number of hungry, disgruntled patients who complain to nurses. Patient and nurse satisfaction is therefore very high. Eliminating the NPO order is a radical thought, but it is something that every interventional program should consider.”

Dr. Kirk Garratt of Lenox Hill Hospital, New York City disagreed. “Fascinating thought, John, but I have to point out the obvious — one aspiration event and you’re toast! In addition, you’re in violation of a ‘thousand’ guideline statements. In NYC, for better or worse, [I believe] this will keep patients fasting.”
I agree with Dr. Bittl’s answer to Dr. Garrett’s dread of lawyers. “It is curious to justify medical practice on dread of litigation in lieu of evidence.”

Dr. Bittl supports this approach with a review of the evidence surrounding the NPO practice. “The scientific evidence for fasting for conscious sedation is very weak. The American Society of Anesthesia guidelines discuss this extensively and have concluded that there is no strong relation between fasting, gastric volume, or risk of aspiration. In any case, the patients at highest risk for nausea and vomiting are those who present with ST-elevation myocardial infarction (STEMI), who are not fasting anyway.

“In the general cath lab population, fasting increases the risk of intravascular volume depletion, hyperglycemia in the diabetic patients, and subsequent risk of acute kidney injury (AKI). Using the legal threat, what is the greater risk: AKI or aspiration? As pointed out, the recommendations vary quite a bit. It’s hard to say that there is a standard.”

Dr. Bittl provided me with two overviews on the subject. Brady et al¹ who addressed preoperative fasting for adults to prevent perioperative complications. They found that recent guidelines have recommended a shift in fasting policy from the standard ‘NPO from midnight’ approach to more relaxed policies, which permit a period of restricted fluid intake up to a few hours before surgery. Brady et al systematically reviewed the literature on different preoperative fasting regimens (duration, type and volume of intake permitted) on perioperative complications and patient wellbeing (including aspiration, regurgitation and related morbidity, thirst, hunger, pain, nausea, vomiting, and anxiety) in different adult populations. The review examined randomized, controlled trials that compared the effect on postoperative complications of different preoperative fasting regimens on adults. Thirty-eight randomized comparisons (made within 22 trials) were identified. Most were based on ‘healthy’ adult participants who were not considered to be at increased risk of regurgitation or aspiration during anesthesia. Few trials reported the incidence of aspiration/regurgitation or related morbidity, but relied on indirect measures of patient safety, i.e., intra-operative gastric volume and pH.

There was no evidence that the volume or pH of participants’ gastric contents differed significantly depending on whether the groups were permitted a shortened preoperative fluid quick or continued a standard quick. Participants given a drink of water preoperatively were found to have a significantly lower volume of gastric contents than the groups that followed a standard fasting regimen. This difference was modest and clinically insignificant. There was no indication that the volume of fluid permitted during the preoperative period (i.e., low or high) resulted in a difference in outcomes from those participants that followed a standard quick. Few trials specifically investigated the preoperative fasting regimen for patient populations considered to be at increased risk during anesthesia of regurgitation, aspiration and related morbidity. Brady et al’s conclusions were that there was no evidence that a shortened fluid quick increased the risk of aspiration, regurgitation or related morbidity compared with the standard NPO after midnight policy. Fascinatingly, permitting patients to drink water preoperatively resulted in significantly lower gastric volumes.
In another study further supporting Dr. Bittl’s view, Soreide et al² reviewed pre-operative fasting guidelines and found that in general, clear fluids are allowed up to 2 hours before anesthesia, and light meals up to 6 hours. The same recommendations apply for children and pregnant women not in labor. Based on the available literature, their task force produced new consensus-based Scandinavian guidelines for pre-operative fasting. Soreide et al emphasized that it remains to be seen to what extent the new liberalized fasting routines should apply to patients with functional dyspepsia or systematic diseases such as diabetes mellitus. Controversial areas still include the effect of fasting in emergency patients, women in labor and in association with procedures done under ‘deep sedation’. Soreide et al concluded that more research on the effect of various fasting regimes in subpopulations of patients is needed to provide evidence-based pre-operative fasting guidelines.

Where does this leave us now? Clinicians should be encouraged to appraise this evidence for themselves and when necessary, adjust their standard fasting policies (NPO from midnight) for patients that are not considered ‘at-risk’ during anesthesia, particularly for those receiving moderate conscious sedation as used in the cath lab. I agree with Dr. Bittl. At least let patients have their morning coffee.

References

1. Brady M, Kinn S, Stuart P. Preoperative fasting for adults to prevent perioperative complications. Cochrane Database Syst Rev 2003;(4):CD004423.
2. Soreide E, Eriksson LI, Hirlekar G, et al. Pre-operative fasting guidelines: an update. Acta Anaesthesiol Scand 2005;49:1041-1047.

Article source: http://www.cathlabdigest.com/articles/CLinical-Editors

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VOLUME: 18
PUBLICATION DATE: Oct 01 2010

Let’s face it, when it comes to myocardial ischemia, minutes count. Period. The nationwide door-to-balloon (D2B) guideline is under 90 minutes, but we all know major adverse cardiac events (MACE), necrosis of heart muscle, and reducing permanent wall motion abnormalities are directly related to the speed at which blood flow can be restored to the myocardium. The question is, how low can you go? Where can we shave minutes off? Is it possible or appropriate to “call it” in the field, bypass the ED and come straight to the cath lab? What are the risks and benefits of doing so?

It seems like just yesterday our 254-bed community hospital located in Orange Park, Florida, transitioned from a one-suite, diagnostic-only cath lab to a full-service cardiac and peripheral interventional center. It was October 13, 2008 when our application of waiver was approved to perform ST-elevation myocardial infarction (STEMI) procedures exclusively and just mere months later, we were granted privileges for percutaneous coronary interventions, acute or elective. Throughout 2009, we performed 1,400-plus procedures, justifying an open-heart program and the construction of two brand new cath lab suites.

Our call back system started with the patient being diagnosed in the ED; the ED staff would contact the nursing supervisor, who would then page the cath lab call team to a “universal” pager number. Initially, we had some minor technical difficulties with our beepers and the call back process in general. We changed pager companies, changed the pagers themselves, modified and honed the system as needed, and now seem to have found a more streamlined process. The ED staff now notifies the PBX operator, who sends out a mass text and page to the on-call team. The text/page includes the patient’s age, sex, ED room number, first three letters of their last name, and first two letters of their first name. If a cath lab team member does not call back within five minutes, the PBX operator will attempt to call their personal phone number. If still unsuccessful, the cath lab supervisor is contacted.

So what’s the next step? Small of having the cath lab call team stay at the hospital 24/7, what can hospital ED staff do to more efficiently prepare the patient while waiting for the call team? Our ED director, Darin Roark, and ED physicians have been phenomenal with their support, experience, and in a way, a sort of “letting go” of control in the ED. Please don’t misunderstand me on this one; I don’t mean providing sub-par care. What I mean is the creation of a system that allows for a quicker hand-off between ED and cath lab. It may mean allowing cath lab staff to start certain GTTs, shave the groin or obtain signed consent, responsibilities that usually fall on ED staff, but can easily be done by the cath lab personnel in order to expedite the process. Sharing responsibility and re-aligning priorities has been an ongoing learning process for us in order to shave life-saving minutes off our D2B time.

We have also incorporated the help of our local EMS. They hold STEMI meetings to help determine the best way to cut down on D2B times and analyze and scrutinize the time in the field. They are currently looking at instituting a regional or at least a northeast Florida STEMI protocol or policy, or at the very least a standard of practice agreed upon regionally that we can all abide by, thus making an entire litany of benefits. The EMS STEMI meetings include our county EMS director, local cardiologists, ED physicians, and hospital administrators, or their respective representatives.

One issue they are working on is whether or not EMS, transporting a STEMI patient, should bypass hospitals that can merely offer facilitated thrombolytic therapy or continue on to a facility that has full PCI capabilities. There are certainly numerous legal aspects to consider. The ideal situation is to have legislation at the state level protecting EMS in the same way that the stroke protocol protects them from bypassing certain hospitals to get to an official stroke center.

The second goal or question of these meetings is to determine if calling the STEMI from the field can help to reduce time. One of our local fire and rescue departments already has the technology to email ECGs directly to our ED, providing a time savings. Our county EMS is investigating another piece of equipment that will allow ECGs to be sent to specific personal computers in the ED, SMS/email, a PDA or any other type of handheld device. The ultimate goal is to develop a common initiative that would allow all area hospitals to share in this sort of STEMI network, where data could be shared and analyzed for quality, efficiency and performance improvement. A common STEMI network among all area hospitals makes a path of data collection, allowing cross-referencing of STEMI amounts, types, dates and times of events, and geographical info. The ability to instill a highly reliable system, assuring quality, efficiency, and providing performance improvement measures, only justifies such an investment further. If it can be measured, it can be managed more efficiently and more effectively.

Finally, the STEMI meetings have also been holding discussions as to whether it is appropriate to allow the paramedics themselves to call STEMIs in the field. This would allow the cath lab team to be paged immediately and depending on travel time, the team could possibly be waiting on the patient to arrive, rather than the patient waiting on us to arrive. Nonetheless, there is a chunk of time that is being underutilized. The time between the patients being picked up in the field to the actual arrival and diagnosis in the ED could be greatly reduced by calling the STEMI in the field and relaying said info electronically to the nearest PCI facility for cath lab team activation. The feeling and thought process of all individuals involved in these STEMI meetings is not focusing just on D2B time anymore, but now thinking more in the terms of EMS-to-balloon time. The question is, how low can we go without compromising the quality of patient care and keeping to a highly reliable system?

With all of this in the works, it’s still yet to be determined what route we will take. But what is clear is that there are very smart people thinking about this topic today, to lay the groundwork for a better tomorrow. In the meantime, we continue to do our part to shave off these precious live-saving minutes in whatever way we can. We have virtually made all D2B times in less than 90 minutes over the last year and a half. We have noticed low and mid 40-minute times when called from the field from Jacksonville Fire and Rescue, and a couple 20-minute times with walk-in arrivals during the day.

When I started this article, I thought it would be a quick and easy article to write, but there are many fascinating variables that play into the D2B time which I never considered. We can control the variables that occur once the patient arrives to the ED, but what about that window of time before they arrive? How can we manipulate these times even more?

The fact is, and remains, that with the availability of sending 12-lead ECGs electronically from the rescue unit, well-qualified field medics calling STEMIs in transit, the coordination of ED and cath lab, redundancy of protocols, and a highly reliable organizational system in place as a whole, 45 minutes should be a very achievable standard. We are just one hospital of thousands that will continue to prove it and that will continually strive to be better for the sake of our patients. n

Paul can be contacted at: Paul.Trenteseaux@hcahealthcare.com

Article source: http://www.cathlabdigest.com/articles/Paul-Trenteseaux-CVT-Orange-Park-Medical-Center-Orange-Park-Florida

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VOLUME: 18
PUBLICATION DATE: Oct 01 2010

Reprinted with permission from the Journal of Invasive Cardiology, May 2010, vol. 22, no. 5.

Balloon angioplasty/stenting has emerged as a highly effective revascularization procedure for renal artery stenosis (RAS).¹ The major complications of balloon angioplasty of the renal artery are dissection, perforation and thrombosis.² Use of balloon-expandable stents has decreased the incidence of restenosis. It has also improved the immediate and long-term results of this technique,³ but the risks of life-threatening complications such as free perforations or aortic dissection persist, as well as the risk of distal embolization. In this context, we illustrate the use of covered stents in 2 patients with RAS and discuss the possible role of covered stents in preventing morbidity and mortality associated with this percutaneous procedure.

Case 1

A 69-year-ancient female patient with RAS was admitted with hypertensive encephalopathy. She was referred for potential renal stenting and angioplasty to optimally control her medically-resistant hypertension. Angiography revealed an 80% stenosis in the proximal left renal artery. The angiographic characteristics of the lesion were suggestive of intraluminal thrombus and mimicked the classic “coral-reef” appearance of an organized thrombus, as described in the carotid vasculature (Figure 1).

There was a 10-mmHg gradient across the stenosis, as measured with a 0.014 inch PressureWire (Radi Medical Systems/St. Jude Medical, St. Paul, Minn.). Lack of optimal medical control of her life-threatening hypertension despite five medications necessitated treatment of her RAS. In view of the obvious risk of distal embolization of the thrombotic lesion, the option of surgical treatment was considered but declined by the family of the stuporose patient. Using heparin for anticoagulation and a 7 Fr internal mammary artery guide catheter for support, a FilterWire EZ™ distal protection device (Boston Scientific Corp., Natick, Mass.) was placed beyond the lesion. A QuickCat™ extraction catheter (Kensey Nash Corp., Exton, Penn.) was used for an attempt at aspiration thrombectomy, without success.

Options at this stage included stenting and angioplasty of the thrombotic lesion without distal protection or the off-mark use of a covered stent graft with an aim to prevent distal embolization of the thrombotic load. Use of a covered stent was preferred by the family and a 6.0 x 15 mm iCast covered stent (Atrium Medical Corp., Hudson, New Hampshire) was deployed over a 0.014 inch Spartacore wire (Guidant Corp., Santa Clara, Ca.). Postdilatation was achieved with a 7.0 x 20 mm OptaPro balloon (Cordis Corp., Miami Lakes, Fl.). There was no residual stenosis and no evidence of distal embolization to any angiographically visible renal artery branch (Figure 2). Her subsequent clinical course was remarkable for recovery from her hypertensive emergency using only three medications and the absence of any renal impairment.

Case 2

An 82-year-ancient female patient with hypertension, chronic renal insufficiency, rheumatoid arthritis and Paget’s disease was referred for an invasive evaluation and prospective treatment of RAS, diagnosed earlier on magnetic resonance angiography.

Angiography confirmed an 80% eccentric stenosis at the ostium of a calcified right renal artery (Figure 3). Using intravenous heparin for anticoagulation and a 6 Fr internal mammary artery guide catheter for support, the ostial stenosis was predilated using a 4 mm balloon advanced over a 0.014 inch Spartacore guidewire (Guidant). A 6.0 x 12 mm Herculink stent (Guidant) was deployed spanning the ostium of the vessel. Control angiography revealed adequate stent expansion and placement, but also demonstrated a persistent contrast staining at the proximal and superior edge of the stented segment (Figure 4). The patient was asymptomatic and hemodynamically stable. The angiographic appearance was concerning due to the presence of a dissection in the wall of the renal artery and the patient was kept under observation on the catheterization table with the guide catheter in place. While contemplating how to proceed, the patient complained of mild diffuse abdominal discomfort approximately 15 minutes after completion of the procedure. A repeat angiogram revealed free flow of contrast medium in a cephalad direction suggestive of either a free perforation or a dissection into the wall of the abdominal aorta. A 5.5 x 15-mm balloon was immediately inflated at the site to “tamponade” the bleed and anticoagulation was reversed with intravenous protamine. The balloon was kept inflated for 20 minutes as the activated clotting time was reduced to

Discussion

Renal artery angioplasty and stent placement are generally well-tolerated procedures. As compared to stand-alone balloon angioplasty, renal artery stenting is associated with improved immediate results and a decrease in the rate of restenosis.³ Complications include contrast-induced nephropathy, thrombosis, distal embolization, renal artery dissection and perforation.² Distal protection devices are attractive for safeguarding against the effects of distal embolization and currently under investigation.⁴ But, the small length of renal arteries and lack of a safe landing zone for placement of distal protection devices is a limiting factor. An alternative strategy could be the use of covered stents.
Covered stents have been used in coronary and peripheral arteries for varied indications. Their cardiac application was initially evaluated in stenotic saphenous vein bypass grafts for protection against distal embolization and prevention of restenosis. The results of the BARRICADE trial⁵ showed an increase in the rate of restenosis with the use of a covered stent as compared to a bare-metal stent in this location, thereby disapproving their application for this indication. But, they continue to be used for treating free perforations in the coronary arteries,⁶ and have proven life-saving in this regard. Their use in the peripheral vasculature is more widespread. Apart from their use in the aorta, they are being increasingly used in the iliac and femoral arteries to treat free perforations⁷ and, aneurysmal dilatations.⁸

Commercially available varieties of stent grafts for non-aortic applications, therefore, conform to the dimensions of the iliac and femoral arteries. Although not intended for use in the renal vasculature, the similarities between the size of renal arteries and either the saphenous vein grafts or the ilio-femoral vasculature makes them potentially usable in this arterial bed.
To date, there are no reported cases of the use of covered stents to decrease the risk of distal embolization in lesions with large thrombus burden. Gaxotte et al suggested that stent-grafts could be superior to bare stents in the ability to minimize embolic complications; but, this has never been studied. She described a 6-month patency rate of 92% in 12 patients in which Jomed stent-grafts were placed within the renal arteries.⁹

These stents were placed for a variety of reasons including renal artery rupture, dissection, aneurysm, in-stent restenosis, chronic total occlusions and ulcerated stenosis. Because covered stents could potentially exclude thrombus from within the lumen of lesions with large thrombus burden, there may be a role for these stents in reducing distal embolization, as shown in our case.

Iatrogenic renal artery perforation can occur from guidewire, angioplasty balloons, stents or even the guide catheter itself.¹⁰ The incidence of serious iatrogenic injuries of the renal arteries after percutaneous revascularization was 3.4–10.0% after stenting in the late 1990’s.¹¹ Covered stents have been found to be effective in treating both coronary and iliac artery perforations.^2,3,12 Extrapolation from these data has led to the use of covered stents for the treatment of renal artery dissections and perforations.¹³
Aortic dissections most likely occur secondary to balloon-mediated intimal tears within the renal vasculature that eventually extend retrograde into the aorta. Intimal tears with contrast extravasation are the result of separation of the intima from the underlying media. Possible risk factors for aortic dissection after stenting of the renal arteries are similar to those that cause dissection and perforation of the renal arteries after angioplasty. These possibly include a large balloon-to-artery ratio, higher inflation pressures, repeat vessel expansion, presence of aortic atherosclerosis, advanced age, presence of long-standing hypertension, diabetes, stenosis location, eccentricity, severity and calcification.¹⁴ It is necessary to consider these factors prior to any renal artery intervention.

The second case described here highlights a life-threatening complication of renal intervention, i.e., aortic dissection. It is vital to realize that this can present in a delayed manner after the intervention, as seen in our patient and also described in earlier reports. This should be kept in mind when confronted with a clinical scenario of abdominal pain and hemodynamic compromise after a renal artery intervention, and an early diagnosis and prompt management can prevent a life-threatening situation.

The authors can be contacted via Dr. Jolly at: njolly@medicine.bsd.uchicago.edu

References

1. Bush RL, Najibi S, MacDonald MJ, et al. Endovascular revascularization of renal artery stenosis: Technical and clinical results. J Vasc Surg 2001;33:1041–1049.

2. Corriere MA, Pearce JD, Edwards MS, et al. Endovascular management of atherosclerotic renovascular disease: Early results following primary intervention. J Vasc Surg 2008;48:580–587.

3. Rocha-Singh K, Jaff MR, Lynne Kelley E. Renal artery stenting with noninvasive duplex ultrasound follow-up: 3-year results from the RENAISSANCE renal stent trial. Catheter Cardiovasc Interv 2008;72:853–862.

4. Cooper CJ, Murphy TP, Matsumoto A, et al. Stent revascularization for the prevention of cardiovascular and renal events among patients with renal artery stenosis and systolic hypertension: Rationale and design of the CORAL trial. Am Heart J 2006;152:59–66.
5. Stone GW, Goldberg S, Mehran R, et al. A prospective, randomized U.S. trial of the PTFE-covered Jostent for the treatment of diseased saphenous vein grafts: The BARRICADE trial (Abstr). J Am Coll Cardiol 2005;45:27A.

6. Bates MC, Shamsham FM, Faulknier B, et al. Artery perforation during catheterization: Fighting with a catastrophe. Catheter Cardiovasc Interv 2002;57:44–46.

7. Allaire E, Melliere D, Poussier B, et al. Iliac artery rupture during balloon dilatation: What treatment? Ann Vasc Surgery 2003;17:306–314. Epub 2003 Apr 28.

8. Scheinert D, Schröder M, Steinkamp H, et al. Treatment of Iliac artery aneurysms by percutaneous implantation of stent grafts. Circulation 2000:102;253–258.

9. Gaxotte V, Laurens B, Haulon S, et al. Multicenter trial of the Jostent balloon-expandable stent-graft in renal and iliac artery lesions. J Endovasc Ther 2003;10:361–365.

10. Friedel JM, Khalil R, Lasorda D. Treatment of iatrogenic renal artery perforation with a covered stent and subsequent rheolytic thrombectomy. J Invasive Cardiol 2005;17:374–375.

11. Beek FJ, Kaatee R, Beutler JJ, et al. Complications during renal artery stent placement for atherosclerotic ostial stenosis. Cardiovasc Interv Radiol 1997;20:184–190.

12. Gunning MG, Williams IL, Jewitt DE, et al. Coronary artery perforation during percutaneous intervention: Incidence and outcome. Heart 2002;88:495–498.

13. Friedel JM, Khalil R, Lasorda D. Treatment of iatrogenic renal artery perforation with a covered stent and subsequent rheolytic thrombectomy. J Invasive Cardiol 2005;17:374–375.

14. Haesemeyer SW, Vedantham S, Braverman A. Renal artery stent placement complicated by development of a type B aortic dissection. Cardiovasc Interv Radiol 2005;28:98–101.

15. Bloch MJ, Trost DW, Sos TA. Type B aortic dissection complicating renal artery angioplasty and stent placement. J Vasc Interv Radiol 2001;12:517–520.

Article source: http://www.cathlabdigest.com/articles/Covered-Stents-Renal-Artery-Interventions

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VOLUME: 18
PUBLICATION DATE: Oct 01 2010

Chronic total occlusions (CTO) in the coronary circulation present a major challenge for the interventional cardiologist. The past few years have witnessed the development of novel techniques and devices to successfully revascularize this hard subset of coronary artery disease. Studies have concluded that CTOs can be found in one-fifth to one-third of patients undergoing diagnostic cardiac catheterization. Frequently, these patients have been referred for coronary angiography due to clinical symptoms or abnormal results of stress test demonstrating ischemia. Increasingly, data from numerous studies suggest that, in the appropriate patient subset, successful recanalization confers a significant survival advantage.^1–6

Our group has been treating CTOs for 28 years. At our cardiac cath lab, we successfully revascularize about 100–150 CTOs each year, with brilliant results. Some lesions have been estimated to date back as far as 42 years. As a radial-first lab, we often approach coronary CTOs from the radial access. Herein, we will discuss some vital aspects of percutaneous coronary intervention (PCI) for CTOs and present three cases performed at our center.

Benefits of CTO-PCI

CTO-PCI has the potential to offer patients several benefits, including symptom relief, improvement in left ventricular function, better long-term survival, reduced predisposition to arrhythmic events and improved tolerance of contralateral coronary occlusion.

Patient Selection

Before attempting to revascularize CTOs, careful consideration must be given to individual risks and benefits for each patient. Indications for opening CTOs include relief of angina, evidence of ischemia in asymptomatic patients, improved left ventricular function and improved long-term survival. Both clinical as well as angiographic features should be carefully reviewed. From a clinical point of view, age, symptom severity, associated comorbidities (like diabetes mellitus and renal disease), and overall functional status are major determinants of treatment strategy. Angiographically, the extent and complexity of coronary artery disease, likelihood for complete revascularization, and the presence and degree of valvular heart disease and left ventricular dysfunction are all vital factors. Some angiographic features are associated with a lower likelihood of success, such as the presence of a blunt or a flush occlusion, the presence of the occlusion at a side branch, small vessel size, marked tortuosity, heavy calcification and the presence of bridging collaterals. Longer lesions have worse chance of success than shorter occlusions.

Access

After all preparatory measures have been completed and the patient has been identified as an individual who would potentially benefit from the procedure, determination of catheter access site and the guiding catheter size are of initial importance. Early preparation and anticipation will provide the operator with a maximum number of options in the face of the unexpected. Hence, it is recommended that an 8 French (F) femoral sheath and a contralateral 5 or 6F arterial sheath should initially be used before anticoagulation. The sheath should be large enough to provide for multiple wires, catheters, balloons, and devices. Dual injection (simultaneous contralateral injection) should be performed to evaluate the length of the lesion, to use as a landmark for the target of the guidewire, and to use as a route for the retrograde approach.

Guidewires

Two groups of wires are usually used for the CTOs, polymer-coated and coil wires. Coil wires are non-hydrophilic and are characterized by better tactile feel and a more controlled torque response when compared with hydrophilic wires. They are less likely to dissect the vessel, but at a cost of more resistance within the lesion, reducing the chances of successful CTO traversal. To compensate, some uncoated, spring-coil wires have a tapered-tip design that offers more penetrating power to the tip. These include the following families of wires: Cross-It (tip diameter 0.010”/0.25 mm) (Abbott Vascular, Redwood City, CA); Persuader 9 g (tip diameter 0.011”/0.28 mm) (Medtronic, Inc., Minneapolis, MN); Confianza (tip diameter 0.009”/0.23 mm) and Confianza Pro 8-20 (tip diameter 0.008”/0.20 mm) (Asahi Intecc, Nagoya, Japan). Alternatively, some guidewires may have greater tip stiffness, rather than sharpness, to increase their penetration capabilities. These include Magic S 9 g (tip diameter 0.0128”/0.32 mm) and Magic Ex 18 g (tip diameter 0.0128”/0.30 mm) (Japan Lifeline, Tokyo, Japan). Polymer-coated wires have a hydrophilic coating that markedly lowers friction, helping the wire to go easily through the vessel lumen. This feature may also increase the risk of advancing the wire into subintimal planes and making a fake lumen, long dissections or perforations. Polymer-coated wires are also more likely to lose their tip-shape than uncoated wires. As a result, many operators use polymer-coated wires when the occlusion has been engaged, but progress can no longer be made with an uncoated wire. There are two different groups of hydrophilic wires; the first group has hydrophilic coating only on the tip and includes the Whisper MS and LS (Abbott Vascular), Pilot 50 (Abbott Vascular), Fielder, Fielder FC, Fielder XT (Asahi Intecc), Shinobi and Shinobi Plus (Cordis Corporation, Miami, FL). The second group is coated along both the shaft and the tip, and includes the Pilot 150/200 (Abbott Vascular), Choice PT/PT2, PT Graphix/ Graphix P2 (Boston Scientific Corp., Natick, MA) and Runthrough Hypercoat (Terumo Medical Corp., Somerset, NJ).

Recently, we have used a new class of wires by Medtronic, the Provia wires, designed for the most hard lesions. This group of wires provides overall “best in class” torque and lesion penetration performance due to the following features:

• High torque core process: Eliminates inherit wire bias and stress to maximize torque response.
• Grind design: Increased length of distal tapers to optimize torque transmission and control.
• Co-axial coil design: Core wire is centered all the way to distal tip for improved steering.
• Rounded tip design: Improves torque and helps eliminate “whipping.”
• Improved coil pitch: Tighter design improves steering and control in confined spaces.

Many operators go from the light wire to the heavy, starting with a soft tip, then change to a harder and stiffer wire, if the lighter and softer wires do not work. For occlusions that are less than 6 months ancient, an intermediate wire will usually work. For harder lesions, older than 6 months, wires with harder tips will often be needed.

Microcatheters/Over-the-Wire

The wire should always be used with an over-the-wire (OTW) balloon or a microcatheter in order to ease torque in the tip response, preventing flexion, kinking, prolapsing of the guidewire, and improving penetration ability. OTW devices also allow modification of the guidewire curve, guidewire reshaping, and exchanging to another guidewire. Once the stiff wire has crossed the CTO and reached the distal right lumen, using OTW devices also allows an exchange of a stiff wire to a floppy wire, minimizing the risk of distal wire perforation or dissection. Microcatheters may provide a better tip flexibility than OTW balloons and may provide better wire manipulation, due to their larger inner lumen, which reduces friction. Microcatheters also have the advantage of a radiopaque marker at the catheter tip, which has a flat end. Both of these characteristics help to avoid advancing too far into the lesion, something that occurs frequently with use of an OTW balloon. The choice between an OTW balloon catheter and a dedicated microcatheter depends on the features and CTO complexity, as well as operator preference. Dedicated microcatheters (below) are available that have the advantage of providing specific characteristics in their use.

Tornus (Asahi Intecc). The Tornus crossing microcatheter has been developed to penetrate severe and hard lesions with greater flexibility and torquability, offering a rotational burrowing and advancement manually, maneuvered by counter-clockwise rotation. The catheter consists of eight individual stainless steel wires (0.007” diameter) spirally bound together to form a tapered microcatheter.

Corsair (Asahi Intecc). The Corsair is a septal dilator catheter used for the retrograde approach. This is a microcatheter dedicated to selective engagement of the collateral channel. It consists of a tapered tip and screw head structure, which reinforces torque transmission for the guidewire and makes better back-up support for CTO penetration. The Corsair possesses a soft tip made of tungsten powder and a 0.8 platinum marker coil 5 mm from the tip, which makes it easy to identify the distal tip under fluoroscopy.

CPS Venture wire control catheter (Velocimed/St. Jude Medical, Minnetonka, MN). The Venture catheter is a deflatable tip catheter that provides directional steering and focused pushabilty for efficient wire placement. The deflatable 8 mm radio-opaque tip can form any angle from 0 to 90 degrees in a single plane, allowing precise placement of the wire within the lesion.

Anchoring Balloon

The balloon anchoring technique utilizes a standard compliant OTW balloon. The wire and balloon are initially advanced together. Once the balloon is adequately placed proximal to the lesion, the balloon is inflated. The balloon then serves as an anchor providing support for the wire and the guide. With this added support, the wire can be more forcefully directed at the CTO. Another variation of this technique involves inflation of the balloon in a side branch, such as the conus or the acute marginal branch. This has the obvious advantage of allowing for contrast injection and free, unobstructed access to the CTO. By applying gentle withdrawal pressure to the balloon and forward pressure on the guide, the support balloon anchoring technique allows for better coaxial positioning and deeper seating of the guide in the target vessel. In general, although this procedure can be performed with a 5F catheter, a 7 or 8F catheter is usually preferred.

We have worked on prototypes that may be more effective for this technique, where the balloon has a shorter tip, as well as a much shorter length (less than 2 in tip length and 5 mm in length). In a silastic tube model, we have shown that such a prototype balloon is more effective as a support system for crossing a ‘putty-type’ total occlusion compared to conventional balloons.7 The balloon size can be dilated to 6 mm and is able to be used in multiple diameter-size silastic tube models.

Crossing Techniques

Parallel Wire Technique. With this technique, if the guidewire enters the incorrect plane, it can be left in place as a marker of the incorrect plane. A second wire, supported by an OTW balloon, probes alongside the first in an effort to find the right lumen. A variation of this method is the ‘seesaw’ wiring technique, where both are supported by an OTW balloon. This enables alternate use of the wires, which easily alternate their roles as marking and advancing wires. The effectiveness of the parallel wire technique is the following: (1) The first wire can occlude the entry site of the fake lumen and can be used as a landmark (with the potential to reduce the contrast; (2) The first wire can modify the arterial geometry, resulting in a reduction of the resistance for the second wire passage; and (3) The second wire can find the right lumen simpler than the first wire, using the first wire as a landmark. In this technique, tapered-tip wires are considered more adequate for the second wire than conventional wires. Tapered-tip wires can make a channel different from the channel made by the first wire, owing to stiff and tapered tips.

The STAR technique. The Sub-intimal Tracking and Re-entry, or the STAR technique, aims at making a subintimal dissection with distal re-entry. A 0.014” hydrophilic wire with a J configuration is utilized. The hydrophilic wire is pushed through the subintimal dissection plane. When pushed distal to the occlusion, the J tip is directed towards the right lumen, attempting to re-enter. It is critical with this technique to maintain a small J loop at the tip of the wire. Because of its proclivity to shear side branches, the STAR technique is best suited for conduit-style vessels with minimal branching structure, such as the right coronary artery (RCA) or obtuse marginal artery branches. This technique is reserved for refractory CTOs with strong indications for revascularization and should only be performed by operators experienced in this technique.

Retrograde Wire Technique. When antegrade crossing of a CTO fails, the retrograde approach may be considered. The retrograde technique uses collateral channels from the opposite coronary artery to approach the CTO retrogradely with a wire and/or balloon. The distal side of the CTO fibrous cap is often less resistant than the proximal cap, and once a wire is engaged within the lesion, it is frequently simpler to traverse than with a traditional antegrade approach, particularly when antegrade branches to the proximal cap exist. The retrograde approach should be considered a primary strategy if the procedure is a second attempt after previous failed attempt, if the CTO has several unfavorable anatomical features, if the CTO is relatively long ( 15–20 mm), if the distal vessels receives visible collaterals, and the donor vessel is healthy. Anatomical features that are more suitable for a retrograde approach are, for example, right ostial left descending artery occlusions without a stump, or medial RCA occlusion with a large marginal arising at the site of the CTO.

Case Reports

Case #1: Introducing Medtronic wires and demonstrating Impella use. This case involves a 59-year-ancient male with a history of a large anterior wall myocardial infarction in 1988. On September 30, 2009, he had a stent placed in the circumflex coronary artery. There was stenosis of the RCA with patent previous stents. The left anterior descending artery (LAD) was chronically occluded in the distal segment. His left ventricular function was diminished with an ejection fraction of 35% and anterior hypokinesia was noted. A month later, the patient presented with acute congestive heart failure (CHF). He had a new apical thrombus. After anticoagulation was started, he had an episode of amaurosis fugax. This responded to enoxaparin and warfarin therapy. The patient presented 6 months later due to CHF exacerbation. His ejection fraction deteriorated to about 15%. An automatic implantable cardioverter-defibrillator (AICD) and synchronized pacemaker were placed. We considered recanalizing the presumed occlusion of the circumflex artery.

On May 4, 2010, we attempted to recanalize the patient’s circumflex artery; but, just the presence of the guiding catheter in the left main artery resulted in hypotension and near respiratory arrest. He was brought back to the catheterization laboratory the next day, and, because of acute exacerbation of his CHF, we placed the Impella device (Abiomed Inc., Danvers, Mass.) via the patient’s left groin.

He had significant disease in the proximal LAD prior to the total occlusion, which was interrogated with intravascular ultrasound. There was 80% stenosis of the proximal LAD. A Cougar wire (Medtronic) was placed in the LAD, followed by a 3.5 x 24-mm Endeavor stent (Medtronic), which was postdilated with a 4 x 15-mm high-pressure balloon. An extra back-up guide (Medtronic) was placed and a 3 x 10-mm anchoring balloon was inflated in the proximal part of the circumflex artery. We used the Provia 6 (Medtronic) and then the Provia 9 wires. We then exchanged for a Transit catheter (Cordis) and distally went in further with a Gold wire (Terumo Medical Corp.). The Gold wire was then exchanged for a Fielder XT (Asahi Intecc/Abbott Vascular) and a 1.5 x 6-mm balloon was placed. We could see that we were under struts from the previously placed stents. We then were able to perform multiple balloon inflations, first with a 1.5 x 5-mm and then an AngioScore balloon (Angioscore, Inc., Fremont, CA). We placed a 3.5 x 18-mm, a 3.5 x 30-mm, and several other Endeavor stents. By the end of the procedure, the occlusion went from 100% to 0%.

This case demonstrates the ability to use the Impella device to treat high-risk chronic total occlusions and introduces several extremely torqueable and maneuverable wires by Medtronic.

Case #2: Use of the radial approach. A 70-year-ancient gentleman was told his right coronary artery (RCA) had been 100% occluded for 6 years. He presented with continued angina and ischemia, not only in the inferior territory, but also the lateral territory. His risk factors for coronary disease include hypertension, hyperlipidemia and known chronic occlusion of his RCA for the last 5 to 6 years.

Angiography showed that a total occlusion of the obtuse marginal was present; multiple injections with several catheters were unable to visualize the RCA. There was no antegrade filling of the RCA with multiple catheters. Aortic root injection did not allow visualization of the origin of the vessel. By observing collaterals, it was clear that the RCA was 100% occluded. The patient was enrolled in the QUICK CTO study (Facilitated Antegrade Steering Technique in Chronic Total Occlusions, BridgePoint Medical) to treat the circumflex artery CTO. With difficulty torqueing the catheter, a long, 65-cm Arrow 7 F sheath (Arrow International, Cleveland, OH) was placed and we used an EBU (Medtronic) curve in a Transit catheter. After 10 minutes of wiring, we were unsuccessful with a Miracle 3 wire (Abbott). The CrossBoss CTO catheter (BridgePoint Medical, Plymouth, MN) was used, and we were able to cross the CTO at first using the Miracle 3, and then the Fielder XT. Several inflations with a 1.5 x 5-mm balloon were performed, followed by successful placement of several Xience (Abbott) stents (2.5 x 8-mm, 2.5 x 12-mm, and 2.5 x 12-mm). At the end of the procedure, TIMI-3 flow was noted.

The patient was brought back 30 days later for recanalization of the RCA via the right radial artery. A 5 F sheath was placed in the left groin, and a diagnostic catheter was placed for simultaneous injections. A JR4 was placed after multiple attempts to visualize the RCA. We were successful with a multipurpose catheter, showing that there was an aberrant takeoff of the RCA with a very straight proximal segment that looked like a bypass graft.

Once the diagnostic study was performed, a Transit catheter was placed, followed by a Miracle 3 wire and then a Fielder XT to cross the 100% occlusion. We exchanged for the Miracle 3 wire to perform balloon angioplasty and placed several drug-eluting stents with the Xience stents. This 6-year-ancient occlusion was successfully recanalized.

This is a case where using the radial approach allowed us to visualize the RCA, something that was not possible from the right groin. Our site is now doing radial-first procedures unless there is a contraindication. There has been increasing experience with the radial approach in the treatment of CTOs. In this case, with brilliant guiding catheter support, the procedure was really quite simple, and the CTO was easily recanalized, even though it was 6 years ancient.

Case #3: Demonstration of the support balloon technique. A 67-year-ancient male underwent coronary artery bypass graft (CABG) surgery in 1983. At that time, it was documented that his RCA was 100% occluded. Because of the recurrence of angina in 1990, CABG was repeated. His coronary risk factors included hypertension, diabetes mellitus and hyperlipidemia.

Two weeks prior to admission, he underwent diagnostic cardiac catheterization because of continued chest pain. His left ventricular size was normal, with a small area of apical hypokinesis at the tip of the apex and an ejection fraction of 60%. The RCA was 100% occluded, the left main coronary artery (LMCA) had minimal plaque, the LAD was really occluded at its origin, and the left circumflex artery (LCX) was widely patent, with a previously deployed stent (also widely patent). The internal mammary graft to the distal LAD was widely patent, with a 20% stenosis at the anastomosis. The patient had been on ranolazine at 500 mg twice daily. This dose was doubled.

He presented 2 weeks later with continued angina. The total RCA occlusion was felt to be the etiology for the pain he had experienced ever since his original surgery in 1983. The patient underwent bilateral access of the left and right groin arteries. A 6F diagnostic catheter was placed to allow contralateral injections of the left system to visualize the collaterals to the distal right. The LAD was occluded and there were no significant septal branches forming retrograde to the collaterals. The patient was given 6,000 units of heparin, and an AR1 (Amplatz right) 8F guide was used, along with a 3.0 x 10-mm long Sprinter balloon (Medtronic) for guiding catheter support (Figure 2). Without the over-the-wire balloon support, the guiding catheter continued to be expressed outside the RCA. With a Miracle 3 wire, minimal passage was possible into the CTO and the total occlusion was crossed with the Confianza wire (Abbott). The over-the-wire balloon was removed and the catheter was exchanged for a Transit catheter. A Gold wire was then placed into the distal part of the RCA. The Terumo Gold wire was exchanged for a Whisper wire (Abbott) and after balloon dilatation, 2 Endeavor stents (3.0 x 12-mm and 3.0 x 30-mm) were placed. At the ostium, a 3.5 x 15-mm Endeavor stent was placed. Diminished flow was resolved by further balloon inflation and intracoronary nicardipine. The total occlusion went from 100% to a widely patent vessel with no stenosis.

This is an example demonstrating the use of a support balloon technique for revascularization of a 27-year-ancient CTO.

Conclusion

With the introduction of newer techniques, enhanced guidewires, and operator experience, more and more CTOs are successfully treated. It is exciting to consider the future of CTO recanalization when increasingly smaller equipment is available and our ability to transverse the most hard CTO is routinely performed. Since all centers and operators differ with their approach, it is vital to share information so that continued progress can be made. At our center, we attempt to revascularize all CTOs in symptomatic patients with appropriate indications.

Cardiovascular Services at St. Luke’s Medical Center Phoenix, Arizona

Cardiac Catheterization Suites
Three state-of-the-art Philips digital cardiac cath suites, along with a 6-bed pre-op area.

Staff
4 registered nurses, 4 radiologic technologists, 3 cardiovascular technologists, 1 unit clerk and the director.

Technology

• Philips Medical Imaging
• McKesson PACS
• Spectranetics Laser
• Bard Crosser
• Abiomed Impella
• Variety of CTO and atherectomy devices

CTO Volume

• Average 100–150 cases per year

St. Luke’s Medical Center is proud to announce it is now an accredited Chest Pain Center and a Cardiac Arrest Center.

CTO and Device Development History at St. Luke’s Medical Center.
St. Luke’s Medical Center has been treating chronic total occlusions for 28 years. Over the years, we have trained physicians in various applications for CTOs in our laboratory. We involve physicians in the community and around the country in these training courses.

We have had the opportunity to work on and witness the development of CTO devices and wire technology. In 1991, St. Luke’s Medical Center was one of the few sites in the United States to first use the Magnum wire (Schneider, Zurich, Switzerland). The Magnum wire was a hollow-tip, honestly blunt device that preferentially went into the fibrous cap rather than into the subintimal space. It is no longer clinically available; but, devices such as the CrossBoss CTO catheter (BridgePoint Medical, Plymouth, MN) and the Wildcat device (Avinger, Redwood City, CA) have more recently been developed. Both use the same principle as the Magnum wire. Our group introduced the polytetrafluoroethylene (PTFE)-covered coronary stent, available today in all interventional labs for sealing off dissections. In the early 90’s, we developed the first coronary hydrophilic wire, the Jag wire, co-developed with Boston Scientific. At about the same time, we co-developed the radiofrequency wire in Japan, which became clinically available in the U.S. in the late 90’s with the Safe-Cross device (Kensey Nash Corp., Exton, PA). We are proud to have been the first site in the United States to successfully treat CTOs with the Safe-Cross. We were the first in the state to introduce the Wildcat device for peripheral CTOs and the BridgePoint device for coronary CTOs. We also introduced the Crosser system (C.R. Bard, Murray Hill, NJ). We performed and described one of the first procedures using the Crosser in the coronary arteries.1 We also were the first lab in the state of Arizona to perform the retrograde approach for chronically occluded arteries. Going through a collateral vessel, the retrograde approach allows us to advance a catheter in a retrograde fashion to the chronic total occlusion. In order to simplify and improve the retrograde approach, we also developed the Micro Elite Snare (Radius Medical, Acton, MA).

References

1. Joyal D, Afilalo J, Rinfret S. Effectiveness of recanalization of chronic total occlusions: a systematic review and meta-analysis. Am Heart J 2010;160:179–187.

2. Aziz S, Stables RH, Grayson AD, Perry RA, Ramsdale DR. Percutaneous coronary intervention for chronic total occlusions: improved survival for patients with successful revascularization compared to a failed procedure. Catheter Cardiovasc Interv 2007;70:15–20.

3. Prasad A, Rihal CS, Lennon RJ, et al. Trends in outcomes after percutaneous coronary intervention for chronic total occlusions: a 25-year experience from the Mayo Clinic. J Am Coll Cardiol 2007;49:1611–1618.

4. Hoye A, van Domburg RT, Sonnenschein K, Serruys PW. Percutaneous coronary intervention for chronic total occlusions: the Thoraxcenter experience 1992–2002. Eur Heart J 2005;26:2630–2636.

5. Olivari Z, Rubartelli P, Piscione F, et al. TOAST-GISE Investigators. Immediate results and one-year clinical outcome after percutaneous coronary interventions in chronic total occlusions: data from a multicenter, prospective, observational study (TOAST-GISE). J Am Coll Cardiol 2003;41(10):1672-1678.

6. Suero JA, Marso SP, Jones PG, et al. Procedural outcomes and long-term survival among patients undergoing percutaneous coronary intervention of a chronic total occlusion in native coronary arteries: A 20-year experience. J Am Coll Cardiol 2001;38:409–414.

7. Heuser RR, Murarka S. The Support-Balloon Technique for Chronic Total Occlusion: Successful recanalization of a 27-Year-Ancient. Vascular Disease Management 2010;7:E171–E174.

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VOLUME: 18
PUBLICATION DATE: Oct 01 2010

What is the size of your cath lab facility and number of staff?
The Robert J. Dole Veteran Affairs Medical Center contains two cath labs, a GE Innova 3100 lab and a GE Innova 4100 lab (GE Medical Systems, Waukesha, WI). In these labs, we not only do cardiac caths and coronary interventions, but interventional radiology and vascular procedures as well. We have a 6-bed cardiac observation area where patients are monitored before and after their procedure. We recover our outpatients and send them home directly from this area, which also serves as the area for doing the transesophageal echocardiograms (TEEs) and cardioversions.

Four cardiologists and 1 radiologist use our labs. The cath lab manager is a radiologic technologist [RT(R), CVT] with an advanced registry in cardiovascular imaging through the American Registry of Radiologic Technologists (ARRT), held also by two other x-ray technologists [RT(R)s]. We currently have 5 registered nurses (RNs) on staff.

Most of our current staff has been with the cath lab since it first opened in August 2006. Our staff has been working in the field for quite some time. Several employees came to us with 20+ years of experience.

What types of procedures are performed at your facility?
We do cardiac procedures such as right and left heart catheterizations, angioplasty, stenting, thrombectomy, intravascular ultrasound (IVUS), use of an intra-aortic balloon pump (IABP) and use of the Radi PressureWire (St. Jude Medical, Minnetonka, MN) to measure fractional flow reserve. We also put in pacemakers and automated implantable cardioversion defibrillators (AICDs), and do TEEs and cardioversions.

We do approximately 12 cardiac procedures per week. We do peripheral vascular procedures as well, performing carotid stenting, abdominal aortograms with runoffs, renals, fistulas, embolization procedures, peripheral thrombectomies, and transjugular intrahepatic portosystemic shunts (TIPS). We do approximately 8 vascular procedures per week.

Does your cath lab perform primary angioplasty with surgical backup on site?
No, we do not have cardiac surgical capabilities at our VA facility. We are using the national guidelines set up by the VA, which require an ambulance on site, ready to transport a patient to a nearby facility for emergent bypass surgery if needed. We adhere to strict guidelines so that our patients are getting the best care possible in this situation.

Prior to our opening the cath lab, patients were transported out to have their heart cath procedures. Since opening our own cath labs in August 2006, we are able to offer a tremendous service to our veteran population. Out of the 415+ angioplasty cases that we have completed, we have had to use the ambulance service twice to transport patients to nearby facility, both times with fantastic success. We also have the Jomed covered stent (Jomed International AB, Helsingborg, Sweden) in case it is needed.

What procedures do you perform on an outpatient basis?
We routinely perform right and left heart caths, TEEs, cardioversions, most vascular cases, and some simple pacemaker cases as outpatient procedures. If an intervention is done, we will keep the patient overnight. If there are mitigating circumstances, any patient could possibly be kept for 24-hour observation or a full admission at the discretion of the physician.

What percentage of your patients is female?
Like most other VA medical centers, only 3.7% our patient population is female. Most of the patient population that we see currently is from an era when women did not predominately serve in the military. As time goes on, we believe that this number will increase, but probably never to the range of non-VA facilities.

How many diagnostic cath patients go on to have an interventional procedure?
Approximately 30% of our diagnostic patients go on to have an interventional procedure.

Do any of your physicians regularly gain access via the radial artery?
Yes. We have protocols in place for radial artery access, and also use special catheters and sheaths.

Who manages your cath lab?
Ruth Russell, RT(R), CVT, is the manager of the cardiac cath lab. Wassim Shaheen, MD, is the medical director of the cardiac cath lab and Abid Mallick, MD, FACC, is the director of cardiology services.

Do you have cross-training?
All of our members are cross-trained to what their specific scope of practice allows. Nurses will cross-train to scrub, monitor and circulate, as well as work in our pre and post op area. Techs are trained to scrub and monitor, and help in the pre and post op area with a nurse. Medications are given only by an RN or physician.

Does an RT (radiologic technologist) have to be present in the room for all fluoroscopic procedure in your cath lab?
One RT(R) is always present in each cath lab procedure.

Which personnel can operate the x-ray equipment (position the II, pan the table, change angles, step on the fluoro pedal) in your cath lab?
The physician usually changes the angle on the II, and whoever is scrubbed in pans the table. The physician is the one who steps on the fluoro pedal for the actual x-ray exposure.

How does your cath lab handle radiation protection for the physicians and staff?
Everyone has a radiation badge and ring, and they are required to wear them on a daily basis. Radiation exposure is monitored by our radiation protection officer. We provide lead aprons and glasses for staff and physicians. We also have lead shields on the tables for additional protection.

What are some of the new equipment, devices and products recently introduced to your lab?
Our lab is relatively new, having only been in operation since August of 2006, so our equipment still seems very new to us. We have the ability to perform intravascular ultrasound with Virtual Histology (Volcano Corporation, Rancho Cordova, CA), and can measure fractional flow reserve (FFR). We are also installing GE’s Innova 3D spin feature on our cardiovascular lab as well. We use the GE MacLab for our hemodynamic and clinical data monitoring, and GE Centricity for image archiving.

What systems are used to encourage the communication of information in your lab?
We have monthly staff meetings with just the cath lab staff as well as monthly cardiology meetings with the staff from nuclear medicine, echo, and stress lab, as well as our cardiology clinic. We may have impromptu meetings when new policies or procedures present themselves.

How is coding and coding education handled in your lab?
We have a master sheet and the monitoring person circles all codes for the performed procedures. A secretary enters the codes into the system used at the VA. Any new procedure code is communicated to the individual who inputs the new codes into the system.

How does your lab handle hemostasis?
We currently have 3 methods of obtaining hemostasis: Angio-Seal (St. Jude Medical), Starclose (Abbott Vascular, Redwood City, CA), and manual compression using the D-Stat Dry Closure Pad (Vascular Solutions, Minneapolis, MN). Whoever scrubs in deploys the device. We have had fantastic success with all of these products and any staff member that deploys a device has completed appropriate competencies. If a closure device was not used, the sheath routinely gets pulled in the lab by whoever scrubbed the case. If we need to use the room immediately after a case, we have a post-procedure area where we can go the patient and pull the sheath.

Post intervention, cases are sealed when appropriate and if not, manual pressure with a D-Stat Dry is used by the nurse in the ICU area.

What is your lab’s hematoma management policy?
We track any hematomas and report them to a committee once a month. We feel very fortunate to have had very little problem with hematomas in the cath lab.

Has your cath lab recently expanded in size and patient volume, or will it be in the near future?
Since we are a honestly new department in a hospital that has been around for a long time, word is still spreading about the services we have to offer. Our numbers are climbing slowly, but steadily, as the patient population learns that we can take of their needs. There have also been inquiries from nearby VA facilities to see if they can refer patients here for cardiac procedures.

What measures has your cath lab implemented in order to cut or contain costs?
A very large percentage of our inventory is consignment, which, of course, helps a fantastic deal. We each routinely question and verify before opening product during a case, which has helped in making sure that the incorrect product is not opened and wasted.

What types of quality/control assurance measures are practiced in your cath lab?
We monitor several items in the lab. We do chart reviews and make sure that the proper documentation is in place for certain markers such as time-out performed, consent signed and various other items.

We track complications, and moderate sedation occurrences for our TEEs and pacemakers, if needed. We also do random checks on employees using universal precautions. Phone calls are done post procedure to make sure that the patients are doing well and to answer any questions that they may have.

We also monitor our hospital policy regarding verbal read-back orders and patient identification.

We track physician fluoro and procedure times, as well as dye counts on each case. For every interventional procedure completed, the patient’s lab values are checked to make sure there is not a drop in the hematocrit or a rise in the creatinine or white blood cells. These values are checked the day of the procedure, as well as the next day, and are reported monthly.

How does your cath lab compete for patients?
Our situation is unique in the sense that only veterans or active military can use our facility. We do, but, compete to make sure veterans know what we have to offer, and that we are very competitive with equipment and procedure offerings. For the most part, most veterans like to have their procedures done here at the VA and prefer to stay here rather than go outside for treatment. We do have to have alliances with other hospitals, since we do not perform cardiac surgery. We have a contract with a local hospital and surgery group to take any patients that either need emergent or scheduled bypass or valve surgery. Some of these patients can get transferred to another VA, but many are done at our contracted hospital.

How are new employees oriented and trained at your facility?
A new employee is teamed up with a mentor. If it is a technologist, they would generally team up with a technologist, and similarly, a nurse will team up with a nurse. Most of our staff came to us from other cath labs in the area. We require an RT (radiologic technologist) license for technologists and nurses are required to be an RN. All of the staff is required to have basic life support (BLS) and advanced cardiac life support (ACLS). The staff is also credentialed with the Kansas State Board of Healing Arts.

What continuing education opportunities are provided to staff members?
The VA is a fantastic place to work and get your CEUs. They are currently funding the RT CEU program through an outside source. All of our technologists’ CEUs can be obtained through this site. Nurses are offered many opportunities as well, ranging from online programs through the education department to on-site programs. The education program strives to provide everyone with many opportunities to learn.

How do you handle vendor visits to your lab?
Vendors sign up on our vendor calendar. They will either call ahead to see what date will work for them or schedule while they are here for their next visit. They are allowed to come up to the lab, and visit with the staff and cardiologist, but we try to keep their exposure to patients to an absolute minimum, because of privacy concerns. If a vendor has to come into the lab, it is clarified to the patient, and it is only with the patient’s signed permission that a vendor may be present during a certain procedure.

How is staff competency evaluated?
Competency for new employees is initially evaluated by preceptors. Annually, we check off a staff competency sheet. We adjust the sheet as new products are brought in throughout the year. High-risk, low-volume items such as the IABP are evaluated more than once a year to make sure everyone is competent. ACLS is required of all staff and rhythm/waveform education is periodically reviewed.

How does your lab handle call time for staff members?
Since we do not have cardiac surgery here, we do not take call.

Do you have flextime or multiple shifts?
Currently, we have not felt the need to have multiple shifts. We work 7 am-3:30 pm, with two people assigned to late-night duty for recovery purposes if needed. This assignment gets rotated throughout the staff.

Has your lab undergone a Joint Commission inspection within the past three years?
We did have an inspection by the Joint Commission just recently and we are pleased to say that our department did very well. The only advice is to do what you do every day by giving the best care possible to each of your patients.

How do you see your cath lab changing over the next decade?
We see our veteran population changing. Currently, we are serving many of the veterans from the Korean War and WWII, and see some Vietnam veterans as well. Each of these veteran populations has specific needs and we must be aware of these at all times. With the Gulf War veterans and the Iraqi War veterans coming to us within the next decade, we will have to adjust to meet their needs as well.

What is unique or innovative about your cath lab and staff?
We have the distinct honor of giving back to those who gave so much to us, our veterans. It is such a privilege to take care of those who gave up and risked so much for each one of us. The veterans we serve are a special population, with a rich background of tales to tell and share.

The staff is a very small group and it feels like family, as we all must work very closely with each other and get along. Since most of us have been here from the time the cath lab first opened, it has been a “growing up” process for us — witnessing the beginning of the lab and its continued growth each month.

What’s special about your city or general regional area in comparison to the rest of the U.S.? How does it affect your “cath lab culture”?
Wichita, Kansas is centrally located in the United States and is called the “Air Capital” because of the many airplane manufacturers located in the area, including Hawker Beech, Boeing, Bombardier, Cessna, and Spirit, just to name a few. Wichita is also home to McConnell Air Force Base, which really formed a joint venture with our cath lab. The base bought one of our cath labs using Department of Defense funds, with the understanding that we would serve the military personnel from McConnell. Of course, it is our pleasure to take care of these individuals currently serving our country.

It truly is an honor and a blessing to take care of our men and women that served our country with such bravery and commitment. Brilliant care is just one small way in which we can repay them.

The Society of Invasive Cardiovascular Professionals (SICP) has added two questions to our spotlight:
1. Do you require your clinical staff members to take the registry exam for Registered Cardiovascular Invasive Specialist (RCIS)? Do staff receive and incentive bonus or raise upon passing the exam?

No, this is not required, but it is encouraged for any staff member who would like to take the exam.

2. Are your clinical and or managerial team members involved with any professional organizations that support the invasive cardiology service line, such as the SICP, ACVP or regional organizations?
Some staff members are associated with the American Heart Association.

Ruth Russell can be contacted at ruth.russell@va.gov

Article source: http://www.cathlabdigest.com/articles/News-0

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