Cordis Receives FDA Approval for Exoseal™ Vascular Closure Device
Cordis Corporation announced the approval of the Exoseal™ Vascular Closure Device in the U.S. Exoseal incorporates a number of new advances in technology and simplicity of design to provide extravascular arterial closure.
“We are very pleased to announce the approval of our first Vascular Closure Device in the United States,” said Campbell Rogers, MD, Chief Scientific Officer and Global Head, Research and Development, Cordis Corporation. “Exoseal has demonstrated excellent clinical efficacy and safety, but also incorporates key design advancements intended to promote safety, ease of use and patient comfort. We are looking forward to building upon the outstanding experience that clinicians and patients have had outside the US since June 2010 when Exoseal received CE mark in Europe.”
The ECLIPSE Trial
The safety and effectiveness of Exoseal was assessed in the U.S. in the ECLIPSE trial, where it was compared with manual compression (MC) with a 2:1 randomization in patients undergoing diagnostic and interventional coronary/peripheral procedures. The trial tested the time to hemostasis, the time to ambulation and the 30-day combined rate of access site-related complications.
“From our experience in the ECLIPSE trial, this new closure device proved to be safe and effective. The results showed that the use of Exoseal significantly reduced time to ambulation compared to MC. There were no major adverse events, no vascular repair, no access site-related bleeding requiring transfusion and no access site-related infection requiring treatment. Based on these results, we believe that use of Exoseal will benefit patients by shortening the time to ambulation, with a low rate of complications. In addition, the device has easy-to-use functionality,” said S. Chiu Wong, MD, Primary Investigator, New York-Presbyterian Hospital/Weill Cornell Medical Center, New York.
These thoughts were also echoed by another primary investigator in the ECLIPSE trial, William Bachinsky, MD, Pinnacle Health at Harrisburg, Harrisburg, Pennsylvania who said, “The Exoseal device offers the use of a fully bioabsorbable PGA plug, which means that nothing is left inside the artery to impede arterial blood flow. The two visual indicators and lockout feature provide additional measures to help ensure precise extravascular placement. Because of the design, there is minimal tugging and pulling required, which could help to improve patient comfort during closure.”
The Exoseal Vascular Closure Device is due to be available to the commercial market in June in the United States. It has been available in Europe, Asia and Latin American markets since June 2010. Cordis will roll out a comprehensive program of customer training to provide users with experience and confidence in the handling and utilization of the device.
Exoseal in Detail
In the ECLIPSE Trial, the extravascular plug placement was associated with no embolization, infection or other major adverse events, comparable to manual compression [despite the significantly shorter time to ambulation for Exoseal]. The bioabsorbable PGA-plug, which is designed to close the femoral artery puncture site with minimal or no inflammation, is fully reabsorbed in 60-90 days. PGA (polyglycolic acid) is a non-collagen plug material that is metabolized to carbon dioxide and water. A system of deployment through the existing procedural sheath means no need for sheath exchange during the procedure. The device uses visual indicators to help the clinician deploy the device correctly. This “visual feedback” also promotes patient comfort during deployment by minimizing tugging and pulling, and the ‘lock-out’ system of Exoseal helps clinicians to achieve proper extra-vascular plug placement.
Drs. Chiu Wong and Bachinsky provide consulting services to the company and are compensated for their work.
Cost Effectiveness Study Determines FFR Can Improve Health while Reducing Economic Burden in UK, France and Italy
St. Jude Medical, Inc. announced that an analysis of the benefits to using a fractional flow reserve (FFR)-guided intervention strategy found that the technology can improve patient outcomes while saving significant amounts of money. Full results for the UK, France and Italy and preliminary results in Switzerland and Belgium were announced at a Late Breaking Trial session at EuroPCR.
The analysis, which was funded by an educational research grant from St. Jude Medical, found that within each of the country’s respective health care systems, the FFR-guided approach is cost-saving, meaning that use of FFR improves health outcomes for patients with multivessel coronary artery disease at lower costs when compared to using angiography alone.
The magnitude of health and budget impact strongly depends on assumptions about the cost of cardiovascular care in each country and local clinical conditions. Additionally, in each country the use of the PressureWire™ technology improved the quality-adjusted life expectancy for PCI patients.
“In each region where this economic analysis was conducted, the PressureWire was found to both improve clinical outcomes by increasing quality-adjusted life years and reducing the number of cardiac events and save a substantial amount of resources,” said Professor Uwe Siebert, MD, MSc, MPH, ScD, from the Health and Life Sciences University of Hall (Austria), who led the research project. “Our research reveals that the magnitude of the health benefits and cost savings from FFR measurement for the European patients and health care payers could be even more significant under an optimal FFR implementation scenario.”
Specifically, in the context of the current healthcare model for each respective country, the analysis found:
In the United Kingdom, FFR use:
- Can prevent on average more than 30 avoidable deaths, more than 70 heart attacks and more than 120 major adverse cardiac events (MACE) over two years;
- Could save the British healthcare system more than 300,000£ in 2011 and more than 800,000£ in 2012;
- Potentially reduces treatment cost for PCI per patient by an average of about 600£ in the UK.
In France, FFR use:
- Can prevent on average nearly 300 avoidable deaths, nearly 700 heart attacks and about 1,200 MACE in France over two years;
- Could save the French healthcare system more than 5 million€ in 2011 and more than 11 million€ in 2012;
- Potentially reduces treatment cost for PCI per patient by an average of about 900€ in France.
In Italy, FFR use:
- Can prevent on average more than 120 avoidable deaths, more than 300 heart attacks and more than 520 MACE in Italy over two years;
- Could save the Italian healthcare system more than 800,000€ in 2011 and more than 3 million€ in 2012;
- Potentially reduces treatment cost for PCI per patient by an average of about 500€ in Italy.
The study was conducted to determine the incremental cost-effectiveness of FFR-guided vs. angiography-guided PCI in patients with multivessel coronary artery disease in the various health care systems in question from the societal perspective. To do this, original patient-level data from the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) study were used.
The methodology of the data analysis in each country was verified by local physicians.
Preliminary results in Belgium and Switzerland also reveal a trend towards cost-savings. The full report for these countries will be revealed later this year.
The benefits of FFR were recognized in the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Guidelines with new recommendations for the treatment of coronary artery disease which support measuring FFR in a wide range of patients before performing PCI or recommending surgery.
About the FAME Trial. The FAME study is a randomized, prospective, multi-center trial which enrolled 1,005 patients with multivessel coronary artery disease. The FAME study compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography using St. Jude Medical’s PressureWire Certus technology exclusively for FFR measurement. The 12-month results, published in the January 15, 2009 issue of the New England Journal of Medicine, demonstrated that instances of major adverse cardiovascular events (MACE), including death, myocardial infarction (heart attack) or repeat revascularization, were reduced by 28% for patients whose treatment was guided by FFR rather than by standard angiography alone.
Two-year results presented as a late-breaking trial during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) Conference demonstrated that patients who received FFR-guided treatment continued to experience improved outcomes over time, including a 34% risk reduction in death or heart attack.
For more information, please visit sjm.com.
Cardiovascular Systems’ COMPLIANCE 360° Trial Demonstrates Superior Acute Results of the Diamondback 360° over Balloon Angioplasty
Data Presented at the American College of Cardiology Scientific Meeting Show Superior Procedural Success Rate, with 91 Percent Less Bailout Stenting
The following is being re-run as a correction due to an error in Table 1 in the May issue. CLD regrets our mistake.
Acute data from Cardiovascular Systems’ (CSI) prospective, randomized COMPLIANCE 360° clinical trial were presented at the American College of Cardiology’s (ACC) 60th Scientific Session in New Orleans. The study directly compared the Diamondback 360® Orbital PAD System versus balloon angioplasty in treating above-the-knee peripheral arterial disease (PAD).
COMPLIANCE 360° acute results (ACC i2 Poster #507) showed that the Diamondback 360° Orbital PAD System can achieve far superior acute results in treating calcium-containing femoropopliteal plaque by improving lesion compliance through a technology known as differential sanding, without the need for stent placement.
According to Principal Investigator Dr. Raymond Dattilo, St. Francis Health Center, Topeka, Kan., “The acute data from the COMPLIANCE 360° trial shows treatment with the Diamondback leads to better luminal gain, improved lesion compliance (as reflected in lower balloon pressures post treatment with the Diamondback 360°) and a marked reduction in bailout stenting. The Diamondback’s unique orbital mechanism of action with differential sanding safely removes calcified plaque, reducing the need for high-pressure balloon angioplasty and stenting.”
The COMPLIANCE 360° study enrolled 50 patients at nine U.S. sites. All patients had been diagnosed with calcium-containing lesions above the knee with ≥ 70 percent stenosis. Additionally, they exhibited Rutherford class 2 to 4 symptoms, that is, mild to severe pain due to blocked arteries. Patients were equally randomized to two groups: balloon angioplasty alone versus treatment with the Diamondback 360°, followed by low-pressure balloon angioplasty (up to 4 atmospheres), if needed, with the angiographic endpoint of a residual stenosis of ≤ 30 percent without bailout stenting.
COMPLIANCE 360° patients will have clinical follow up at one, six and 12 months, along with duplex scanning and ankle brachial index evaluations. For more information, visit the company’s website at www.csi360.com.
Concerns About Bias in Commercially-Funded CMEs
Commercial funding of continuing medical education (CME) and the potential for bias appear to concern many health care practitioners and researchers, but many reported being unwilling to pay higher fees to eliminate or offset commercial funding sources, according to a report in the May 9 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
From January through June 2009, Jeffrey A. Tabas, MD, from the University of California San Francisco, and colleagues surveyed attendees at live CME courses delivered by the International AIDS Society–USA (IAS-USA), a nonprofit organization that pools the support it receives from industry so that no one company funds any particular program. In total, 770 attendees (a 57% response rate) completed the 22-item survey, which focused on beliefs about commercial funding and potential for bias, willingness to offset the cost of commercial support, knowledge about the costs of producing CME programs, and demographic information. Participants included physicians, nurses, nurse practitioners, physician assistants, and persons with PhDs or other academic degrees. “Our two main outcome variables were dichotomized as follows: (1) agreed or strongly agreed that raising the registration fees is an effective way to decrease commercial support vs. not, and (2) agreed or strongly agreed that commercial support for live CME should be eliminated vs. not,” the authors explain.
The majority of respondents (88 percent) reported that commercial support of a CME activity introduced the potential for bias. This perception of bias was also directed toward CME faculty who receive support from industry. Fewer than half (46 percent of physicians, 41 percent of other health professionals) thought that raising event-registration fees would help reduce commercial support. Most of those surveyed were unaware of the actual cost of running a CME program, with 75 percent (577 of 770) overestimating the amount of funding derived from attendee registration fees.
Overall, participants who suspected industry bias in CME were more likely to favor reducing or abolishing such funding. But the majority of the group would opt against raising registration fees or offering fewer topics or speakers, among other measures. “These results highlight the complexities of eliminating or decreasing commercial support for CME at this time,” note the authors. “Given the reality that CME learners underestimate the actual costs of live CME activities, the impact of decreases or changes in funding sources needs to be further clarified, and an understanding of the perceptions of these learners and efforts to better inform these clinicians of the true costs of CME needs to be taken into account in the implementation of any policy change.”
Source: Arch Intern Med 2011;171:840–846; 847–848.
Abbott Receives FDA Approval to Expand Use of the RX Acculink® Carotid Stent System to Patients at Standard Surgical Risk
The U.S. Food and Drug Administration (FDA) approved the Rx Acculink® Carotid Stent System for the treatment of patients with carotid artery disease who are at standard risk of adverse events from carotid endarterectomy. Rx Acculink was previously indicated for patients at high risk of adverse events from surgery. This expanded indication is supported by the results of the CREST (Carotid Revasculariza-tion Endarterectomy vs. Stenting Trial) study. Rx Acculink is used with the Rx Accunet® Embolic Protection System.
As part of its submission for an expanded indication, Abbott submitted the results of the CREST study, which is the largest prospective study conducted to date comparing carotid artery stenting to surgery. CREST was sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), and was partially funded by Abbott. The trial demonstrated that carotid artery stenting and carotid surgery had similar safety and long-term outcomes for standard-risk patients with symptomatic and asymptomatic carotid artery disease.
Abbott intends to seek expanded Medicare coverage for carotid stenting based on the CREST trial results. In addition, the company plans to initiate a post-approval study of the Rx Acculink Carotid Stent System in patients at standard surgical risk later this year. The study is planned to assess clinical outcomes at 30 days and annually for three years.
The Rx Acculink Carotid Stent System, used in conjunction with the Rx Accunet Embolic Protection System, is indicated for the treatment of patients at high risk and standard risk of adverse events from carotid endarterectomy who require carotid revascularization and meet certain criteria.
Additional information about the Rx Acculink Carotid Stent System, including important safety information, is available online at www.abbottvascular.com/static/cms_workspace/pdf/ifu/carotid_intervention/RX_Acculink_Carotid_Stent_System.pdf
Physio-Control Introduces New Hospital Solutions for the Lifepak 15 Monitor/Defibrillator
New Feature Set Includes External AC/DC Power and Temperature Monitoring for Therapeutic Hypothermia Patients
Physio-Control, Inc. announced availability of new solutions for the Lifepak® 15 monitor/defibrillator designed to help hospital, as well as pre-hospital, teams provide more effective patient care. The 15, when used together with Code-Stat™ data review software and the Lifenet® System data network, empowers hospital and pre-hospital care teams with a powerful new suite of tools.
The new solutions include:
- External AC/DC power – Ideal for hospital use or in emergency medical services (EMS) vehicles with AC power. The external power adapter charges the batteries while connected to AC or DC power, providing up to 6 hours of battery run time, and features a break-away connector allowing for immediate portability. New on-screen indicators display external power status and battery charging state.
- Continuous temperature monitoring – Allows clinicians to continuously monitor temperature for therapeutic hypothermia and other critical patients. Patient temperature data can be displayed, saved and transmitted with other monitoring parameters and trended during post-event review with Code-Stat.
- Continuous waveform capture and storage – Saves waveform data from all three channels (ECG, SpO2, CO2), allowing for more complete post-event review in Code-Stat. Clinicians can now correlate capnography waveforms with changes in a patient’s status. Additionally, STJ values are now included on the 12-lead ECG printout to help clinicians identify critical changes.
- Automated self-reporting capabilities – Important device information such as device readiness, usage data and battery information can be combined with Lifenet Asset to provide customers with a new level of insight into their device readiness, simplifying management of setup options and allowing customers to perform their own device software updates.
As an upgradeable platform, the 15 can adapt to evolving protocols and new guidelines as customers prepare to deliver new capabilities. The 15 provides the widest range of energy dosing up to 360 joules, CPR metronome for guiding chest compressions, and a broad selection of monitoring options, including non-invasive continuous EtCO2 monitoring and monitoring of carbon monoxide, SpO2 and methemoglobin offered by Masimo®.
For current Lifepak customers, the 15 reduces transition costs, with a user interface that complements the Lifepak 12 defibrillator/monitor. Emergency care providers are able to work with a mixed fleet of Lifepak monitors, and transition their equipment when budgets allow.
To find out more about Physio-Control, visit www.physio-control.com or call 1-800-442-1142.
Mechanical Chest Compression Follows Patient into CCL
Olson says she wants everyone to know that what Whatcom Medic One paramedics and caregivers at the PeaceHealth St. Joseph Cardiovascular Center in Bellingham, Washington, did for her was “immeasurably wonderful,” and that she cannot fully express her gratitude.
On Sunday, April 10, Olson believed she was suffering from food poisoning, but when she also began experiencing chest pain in her motel room, her friend called 911. When paramedics arrived, Olson had just gone unconscious and they found her heart had stopped beating.
Efforts to revive her included defibrillation and administration of cardiac medications, but despite these measures, her heart would not restart. During the resuscitation effort, a new mechanical CPR device being evaluated by the Bellingham Fire Department was attached to Olson. This piece of equipment, called the LUCAS Chest Compression System (Physio-Control, Inc., Redmond, Wash.), is designed to compress and expand the chest in an attempt to circulate blood when the heart is unable to do so. Paramedics also used the ResQPOD (Advanced Circulatory Systems, Inc., Roseville, Minn.), an impedance threshold device (ITD) that provides perfusion on demand (POD) by regulating pressures in the thorax during states of hypotension.
In Olson’s case, this was so effective she regained a pulse and consciousness, a very rare occurrence in out-of-hospital cardiac arrest situations. The paramedics were then able to obtain a 12-lead electrocardiogram (Figure 1). Olson then lost her pulse and the LUCAS restarted, as well as the ResQPOD. She was rushed to the PeaceHealth St. Joseph emergency department and her pulse returned. Olson was quickly taken to the cath lab with the LUCAS and ResQPOD turned off, where Dr. William Lombardi opened her left anterior descending coronary artery.
Today, Olson is alive and well with normal neurologic function, expecting to be discharged home just days after suffering a typically fatal cardiac arrest. Olson has given permission to make her story known in order to educate the community and express her gratitude to everyone involved.
Dr. Marvin Wayne commented, “It is amazing. We had to fully sedate her during the LUCAS operation and for intubation since she was so awake.”
Bellingham Fire Chief Bill Boyd, whose department operates Whatcom Medic One, said, “This story isn’t just about technology, it’s about people working together to ensure that anyone in Whatcom County has access to first-class emergency care, from the moment we receive a 9-1-1 call, through the hospital emergency department, and until a patient like Nancy Olson goes home — alive and well.”
Abiomed Announces New PROTECT II Data
Abiomed, Inc. announced results from further 90-day clinical and economic analyses, based on data from the PROTECT II study. The analyses showed a significant reduction of 29% in the major adverse cardiac and cerebrovascular event (MACCE) rate for the Impella arm at 90 days. Additionally, the Impella patient population had an overall average hospital charge savings of $19,000 (all patients) to $22,000 (survivors only) without device costs included. With the device costs included, hospital charges with Impella ranged from being equivalent to $3,000 less than the intra-aortic balloon pump (IABP).
The analyses were presented by William O’Neill, MD, executive dean for clinical affairs at the University of Miami Miller School of Medicine and principal investigator of the PROTECT II study, at the Society for Cardiovascular Angiography Interventions (SCAI) 2011 Scientific Sessions in Baltimore. The PROTECT II study was a prospective, multicenter, randomized trial, designed to measure a composite of major adverse events at 30 days, with 90-day follow up in high-risk percutaneous coronary intervention (PCI) patients requiring hemodynamic support, comparing the Impella 2.5 to the IABP.
Summary and Conclusion of PROTECT II (Per Protocol):
- Positive overall outcomes for the Impella arm over the IABP arm in the entire study cohort at 90 days, resulting in a 21% reduction in major adverse events over the IABP (p = 0.029);
- In the pre-specified high-risk PCI without atherectomy subgroup (88% of study), Impella provided a significant benefit over the IABP at 30 days (p = 0.009) and at 90 days (p = 0.003) with a 29% reduction of major adverse events;
- There was a significant 29% reduction of the MACCE1 rate at 90-day follow up per protocol in the Impella arm compared to the IABP arm (p = 0.038).
“The PROTECT II data continues to be clinically relevant, particularly at the 90-day mark,” said Dr. O’Neill. “Our most recent analysis, presented today at SCAI, shows a significant reduction in MACCE in favor of Impella. This important finding provides new guidance for interventional cardiologists in selecting the appropriate type of support and its impact on patient care in high-risk PCI.”
Economic Study Analysis:
In PROTECT II, Impella significantly reduced out-of-hospital major adverse events by 56% (p = 0.002) over the IABP arm. The economic study includes additional patients and readmission data (n = 249) from the initial PROTECT II presentation at the American College of Cardiology (ACC) Scientific Session in April 2011.
Hospital charges for all PROTECT II patients at 90 days averaged approximately $165,000 per patient for the IABP and approximately $146,000 for Impella, resulting in $19,000 lower charges with Impella support. Hospital charges for survivors only averaged approximately $156,000 per patient for IABP and approximately $134,000 for Impella, resulting in $22,000 lower charges with Impella support, excluding device costs.
Overall Hospital Charges at 90 Days Without Device Costs
- 47% reduction in repeat revascularization for Impella patients at 90 days;
- 67% lower charges per readmission for Impella patients at 90 days.
The device costs were subtracted out of the economic study data and added back in at hospital cost assumptions. With device costs included ($20,000 for Impella, $800 for IABP), the hospital charges become equivalent at 90 days. Additional economic study information will be presented at a later date. This economic study was conducted by Presscott Associates, Ltd., an independent health economics organization. Analysis included third-party collection and analysis of medical billing data from actual claims submitted to payers.
These data reported have been collected, monitored and analyzed by a third party academic research organization and Presscott Associates, Ltd.
For additional information, please visit www.abiomed.com.
- MACCE is defined as composite of major adverse cardiac and cerebrovascular events, including death/stroke or TIA/MI/repeat revascularization in the PROTECT II study, using 8xULN for biomarkers or Q-wave for peri-procedural MI (Stone, et al. Circulation 2001;104:642–647) and 2xULN for spontaneous MI (PROTECT II definition).
- The PROTECT II study was a prospective, multi-center, randomized controlled study of the Impella 2.5 versus the intra-aortic balloon pump (IABP) in patients undergoing non-emergent high-risk PCI requiring hemodynamic support. The purpose of the PROTECT II study was to determine the safety and effectiveness of the Impella 2.5 as compared to optimal medical management with an IABP during “high-risk” angioplasty procedures. The study protocol was for low ejection fraction (EF) patients with unprotected left main (EF ≤ 35%) or with triple vessel disease (EF ≤ 30%). The primary endpoint of the study is a composite of the following ten major adverse events at 30 days or discharge: death, myocardial infarction, stroke, repeat revascularization (PCI/CABG), need for any cardiovascular operation, acute renal dysfunction, increase in aortic insufficiency, severe hypotension, CPR or arrhythmia requiring Trt, failure to adequately reopen the vessel. The thesis assumed major adverse event rates of ≥ 20% for Impella and ≥ 30% for IABP.
- Coronary atherectomy, commonly referred to as rotablation, is a catheter-based procedure that includes a high-speed rotating metallic burr that abrades calcified plaque that is blocking an artery and blood supply to the heart, rotating at speeds of up to 200,000 rpm. Complications listed per FDA labeling include: ventricular perforation, contrast media reaction, stroke, slow flow, no flow, myocardial infarction (Q-wave and non Q-wave), arrhythmia requiring treatment, cardiac tamponade, and death.
- All of the adverse events of the study have been independently adjudicated by the third party academic research organization (ARO). However, the database is not locked as of the Society of Angiographic Cardiovascular Interventions (SCAI) Scientific Sessions in May 2011.
- All economic data has been collected by Presscott Associates, Ltd. in unison with the ARO. Additional patients may be added in the future to the economic report. As of this press release, n = 249 is comprised of patients that consented to the economic study and were in the United States.
- Statistically significant p value of p ≤ 0.05 means that the likelihood that the phenomena tested occurred by chance alone is less than or equal to 5%.
Follow-up Rehab Boosts Survival Odds for Angioplasty Patients
Patients who undergo angioplasty are more likely to survive longer if they participate in structured follow-up care, according to research in Circulation: Journal of the American Heart Association. In their 14-year analysis, researchers discovered a 46 percent relative reduction in death from all causes in patients who participated in cardiac rehabilitation following angioplasty.
Using data from a Mayo Clinic registry of PCI patients, along with telephone follow up, the researchers examined outcomes for almost 2,400 patients who underwent a first PCI in the Rochester, Minn., area from 1994 to 2008, and survived their hospital stay. “Our findings show that patients who participate in cardiac rehabilitation following PCI have better long-term survival — about 50 percent better — than those who don’t participate in cardiac rehabilitation,” said Randal Thomas, MD, MS, lead author of the study and director of the Mayo Clinic’s Cardiovascular Health Clinic in Rochester, Minn.
The results accounted for smoking status, obesity, high cholesterol, family history, and certain medical conditions that might affect life expectancy, such as heart failure, kidney disease, or diabetes. The researchers noted a difference in death rates starting at one year of follow up. Improved outcomes were among men and women, older and younger patients, and in patients who had undergone elective or non-elective PCI.
Almost 400 patients had subsequent heart attacks and 755 had additional procedures to open blocked vessels. In all, 503 patients died during follow up; 199 of the deaths were validated as being cardiac-related.
Since the study was observational rather than randomized, researchers used three statistical techniques to account for factors that might bias their results. For example, younger, healthier, more motivated patients who were already more likely to live longer were also more likely to participate in cardiac rehabilitation.
Although the study population was predominantly white, the results are consistent with other studies of cardiac rehabilitation in other patient subgroups with cardiovascular disease that have included larger groups of non-white patients, Thomas said. He said the study results should be further validated in other patient populations.
Cardiac rehabilitation is recommended in the 2005 American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions Guideline Update for PCI. But only about one-quarter of eligible U.S. patients participate, the researchers said. Gains in long-term survival would be substantial if all eligible PCI patients received cardiac rehabilitation, Thomas said.
Even in the unlikely event that the study results overestimate the true impact of cardiac rehabilitation and such services reduced deaths within five years by only 20 percent to 30 percent (instead of 46 percent, as found in the study), its impact on survival would still be substantial for patients after PCI, he said.
Most insurance companies cover up to 36 sessions of cardiac rehabilitation following PCI, heart attack and some other heart conditions. Medicare, which approved coverage of the programs for PCI patients beginning in 2006, typically covers 80 percent of the costs. Participation by patients following PCI appears to have increased since the Medicare change in 2006, although Thomas said many doctors and patients still remain unaware that coverage for cardiac rehabilitation is available following PCI.
Study Evaluates First-in-Human Use of Robotic-Assisted Angioplasty Procedures
Researchers achieve a 100 percent clinical success rate with the CorPath® 200 System, while reducing radiation exposure by 97 percent
Corindus Vascular Robotics announced that the Journal of American College of Cardiology: Cardiovascular Interventions (http://interventions.onlinejacc.org/cgi/content/abstract/4/4/460) published the results from the first-in-human clinical study of its CorPath® 200 System in the April 2011 issue (2011;4:460–465). The study was designed as a single-arm, open label, prospective trial to evaluate the safety and technical efficacy of the CorPath 200 System in delivering and manipulating coronary guidewires and stent/balloon systems in percutaneous coronary intervention (PCI) procedures. Initial results of the study were presented in September 2010 at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 conference.
The study enrolled eight patients with coronary artery disease indicated for elective PCI at the Corbic Research Institute in Envigado, Colombia. The lead authors of the study, Dr. Giora Weisz, interventional cardiologist at New York-Presbyterian Hospital, director of cardiovascular clinical research at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center, assistant professor at Columbia University College of Physicians and Surgeons in New York and Dr. Juan Granada, medical director of the Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation (CRF) in Orangeburg, NY, utilized the CorPath 200 System to perform the procedures, achieving a technical success rate of 97.9 percent. All patients were discharged home with less than 30 percent stenosis within 24 hours after the intervention, and completed a 30-day follow up without the incidence of major adverse cardiovascular events (MACE). Additionally, the operators rated the robotic system’s performance as “equal to” or “better” than manual procedures in 97.5 percent of the cases.
Dr. Granada, who led the preclinical studies with the CorPath System, served as the lead investigator. He commented, “The primary endpoints of the trial were achieved in all patients, achieving a 100 percent clinical success rate. The results mark a significant evolution in interventional device technologies as the actual procedural method of PCI procedures has remained unchanged in the last 25 years.”
Another important finding of the study was the reduction of radiation exposure to the operator. According to recent data published in Catheterization and Cardiovascular Interventions (http://onlinelibrary.wiley.com/doi/10.1002/ccd.21801/abstract), an interventional cardiologist’s daily exposure to radiation and the physical stresses inherent in the cath lab can lead to occupational health risks — including orthopedic problems, cataracts and cancer. Utilizing electronic direct dosimeters, the investigators found the operator’s radiation exposure was 97 percent lower than the levels found at the standard table position.
“As the current practice of interventional cardiology evolves into more complex PCI procedures, there is a need for improved safety and ergonomics in the cath lab while improving the efficiency of the procedure,” said Dr. Granada. “My early experience demonstrated feasibility, safety and procedural effectiveness with the CorPath 200 System that is comparable to manual operation. I am looking forward to receiving the multi-center CorPath PRECISE results to further validate the CorPath technology in day-to-day practice.”
The CorPath 200 System allows for controlled robotic-assisted placement of coronary guidewires and stent/balloon catheters from an ergonomically optimized interventional cockpit. The lead-lined cockpit protects the operator from radiation exposure. The comfortable seated position in front of the “slaved” monitors provides enhanced visualization of the angiography screen while reducing fatigue and minimizes head, neck and back strain.
The CorPath PRECISE trial, led by Dr. Giora Weisz and Dr. Joseph Carrozza, chief of cardiovascular medicine at Steward Health Care System, St. Elizabeth’s Medical Center in Boston, is expected to enlist 175 patients at leading medical centers across the United States. The results of this study will be the basis for a pre-market clearance 510(k) application to the FDA.
Additional information can be found at: http://www.corindus.com
Note: The CorPath 200 System is an investigational device and limited by federal law to investigational use only.