Arguably the hottest trial at last week’s Transcatheter Cardiovascular Therapeutics (TCT) conference was PARTNER. The PARTNER trial compared outcomes between standard therapy for patients with inoperable severe aortic stenosis and transcatheter aortic valve implantation (TAVI). TAVI is a new procedure where a bioprosthetic aortic valve is inserted either femorally or transapically by catheter and then implanted within the native aortic value. Previous to the release of PARTNER, the assessment of efficacy and safety of TAVI was confined to registries and various modest-sized Phase I trials.

PARTNER is a landmark trial in the management of patients with severe AS. Median survival time for patients receiving standard treatment is two years. TAVI resulted in 45% reduction in all-cause mortality and 61% reduction in cardiovascular mortality at 1 year in high-risk AS patients compared with standard therapy.  Further support of TAVI was that echocardiographic criteria such as aortic valve area and mean aortic valve gradients all improved as did symptom criteria such as the patients’ NYHA class.

Important cautions were noted in PARTNER: although the procedure can reduce mortality, there was a significantly higher risk of major vascular complications and major bleeding, and a trend towards a higher risk of major stroke in the TAVI arm.

Thus, while the overall results are very exciting, the high complication rate should temper overenthusiastic tendencies toward the aggressive use of TAVI. The results also should encourage the development and application of adjunctive intravascular techniques to diminish the stroke risk and, clinically, employ better case selection for either the femoral or transapical approach to minimize the vascular complications.

Thoughts
Although the findings of the study itself are clinically important, the regulatory background in which TAVI finds itself deserves special comment. TAVI is not yet approved as a treatment option in the U.S., although it is extensively used in Europe and other areas of the world.

This approval conundrum brings up two thoughts to mind:

1. TAVI already is highly in use in Europe. A TAVI registry in Great Britain for example already has over 1,200 patients enrolled. Is this an indication that the U.S. has lost its once-felt leadership in innovation and technology? The U.S. health care system, for all its flaws, has been considered the leading innovator in cardiovascular disease due to our highly skilled and visionary cardiovascular specialists working collaboratively with our industry partners.  Does this imply that our colleagues at the FDA should pursue additional avenues to foster innovation and assess safety and efficacy of new technology?  Are there ways the FDA could decrease the evaluation time necessary prior to the release of new technology into the marketplace if we had better post-market device surveillance routinely put into place?
   
   
2. Will the PARTNER trial alone be enough to earn FDA approval? And if (or as most of us feel when) approved, what can the FDA and  professional societies such as the ACC and SCAI do to help ensure patient safety with the diffusion of this new technology into the community? Clearly, interventionalists who perform TAVI will need special training, and the FDA likely will need to set out criteria for who can perform TAVI to ensure competence in this area. The ACC through its Interventional Council and competency and training documents -- along with our partners at SCAI and industry itself -- will all play an important role in ensuring patient safety as TAVI use is approved.
   
   FDA also will clearly need to monitor adverse outcomes and communicate how these adverse outcomes can be minimized.  Creating a TAVI registry within our NCDR suite could help implement the rigorous post-market surveillance desired as well as provide rich clinical information that could advise clinicians, the FDA, and payers for better patient selection for TAVI use. Participation in this registry might have additional appeal to interventionalists if it means they can have earlier access to TAVI’s innovative technology. The PARTNER trial well demonstrates the partnerships needed between industry, the FDA, professional societies and payers to be able to provide our patients with practice innovations in a safe and effective manner and in a timely fashion.

What are your thoughts on the trial and its implications? You can also comment on the CardioSource Trial Summary.

Speaking of workforce issues, HHS Secretary Kathleen Sebelius and Mary Wakefield, Ph.D., R.N., Administrator of the Health Resources and Services Administration, earlier today announced $320 million in grants under the Affordable Care Act (ACA) to strengthen the health care workforce.  Of those grants, $253 million will go to improve and expand the primary care workforce under the Prevention and Public Health Fund of the Affordable Care Act.  Another $67 million in Health Profession Opportunity Grants will provide low-income individuals with education, training and supportive services that will help them prepare to enter and advance in careers in the health care sector.

According to Sebelius, the grants will help “ensure patients have access to care earlier in a way that is more cost-effective and health effective. “ Specifically, the grants will go towards increasing the number of medical residents in high needs fields and opening up opportunities for high-level nursing education.

Wakefield outlined the specific investments, noting that they are intended to help “counter the years of under-funding and/or de-funding of health care professionals.”  According to Wakefield, nearly $200 million will go towards residency expansion in general pediatrics, internal medicine and family medicine, with the goal of nearly 900 new primary care professionals by 2015. In addition, funds will be used towards a physician assistant training program and to invest in advanced nursing training.

Visit the HHS website for more detailed information about the grants.

Health care has been the major job engine for the U.S. for a decade. The Obama folks hope this will continue as a result of the health reform law (the Affordable Care Act or ACA). Republicans believe the bill will be a job killer. White House Office of Health Reform Director Nancy-Ann DeParle spoke recently about the Affordable Care Act and the 3.2 million jobs the Administration believes it will create by 2018, in part, by removing waste and inefficiency from the health care system.

The new law will likely spur demand for physician assistants, home health aides, health researchers and health IT professionals. Because the law funds community clinics and public health agencies as well as adding new patients to doctors’ offices, DeParle said job creation in health care will stimulate the entire economy. A panel discussion followed DeParle’s remarks.

The panelists emphasized:

• The need for more science and innovation and a need to be able to attract scientists to the major universities and have them know there will be funding for their discoveries to go to market. 
• A need for new models of health care delivery to improve quality and decrease cost – with a specific example of wanting to better help patients transition out of the hospital and making sure they connect with the proper people before leaving to ensure they are taken care of (much like the ACC’s H2H program)
• A trend in increasing use of and reliance on community health centers
• A trend toward more home health care providers and primary care physicians
• Health IT is predicted to greatly and positively affect the relationship between physicians and patients; many see a consumer (particularly the younger generation) drive to have EMR become available on devices such as the iPad (regardless of HIPAA laws)

It remains to be seen if DeParle’s predictions about job creation from reducing inefficiency will be realized, but if we do expand access for 35 million more people in 2014, there will be a very large number of new jobs for health care professionals.

Every year I come away amazed by the College’s Legislative Conference.  I have attended the conference for the past five years and in my opinion this was the best one ever. I want to take one more opportunity to thank all of the ACC staff, the Advocacy committee, the PAC Board, and anyone else I forgot to thank in person who had a hand in creating this outstanding conference.

We need to keep this momentum going forward, to recognize that advocacy is an ongoing effort, that relationships are key, and that multiple viewpoints can be expressed in a civil exchange of ideas. I encourage all of you to continue sharing your ideas and experiences on this blog and in the special Legislative Conference Forum on CardioSource Communities.  Also, CVN has posted a great overview video of the conference, which is below. You can view all the Leg Conference coverage on the blog here.

The bad news for Avandia continues. The FDA announced today that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control the disease with Actos (pioglitazone) or other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia. This is an interesting announcement given that Actos is currently under review for a potential link to bladder cancer (no definitive link has been made as of yet).

In July, after an intensive two-day hearing regarding the conflicting data surrounding Avandia, a FDA advisory panel voted in late July to keep the drug on the market with the addition of warnings and stricter product labeling. See previous blog coverage of Avandia for more background.

UPDATE: European regulators have announced that Avandia's approval will be withdrawn.

This post is written by incoming ACC President David Holmes, MD, FACC, who made the TCT announcement this morning at the TCT symposium.

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Exciting news fromTCT (for those of you who are unfamiliar, Transcatheter Cardiovascular Therapeutics is the annual medical and scientific symposium of the Cardiovascular Research Foundation): The ACC will become an official co-sponsor of the annual TCT symposium beginning in 2011. Future meetings will be known as “Transcatheter Cardiovascular Therapeutics in Partnership with ACC.”

What does this mean? Basically, the new partnership enhances an existing partnership that the ACC already has with CRF. Back in 2008, the ACC and CRF signed an agreement where CRF agreed to help coordinate the interventional content at ACC’s annual i2 Summit.

Today’s announcement means the two groups will work together on a partnership that involves sharing content and distribution of educational materials. The ACC and CRF will form a physician-led “Collaborative Council” of senior physician leaders that will meet regularly to review progress towards established objectives and to set the strategic direction of the affiliation. ACC and CRF staff will also meet regularly to share best practices, consider joint procurement of vendors, consider reciprocal exposition space at annual meetings, and explore collaboration around industry training programs.

There's nothing more important than education. The ACC and CRF believes that this collaboration will enhance and expand the educational opportunities available to interventional cardiovascular professionals, so that they are better prepared to translate evidence-based science into clinical practice. CRF has been helping the ACC with i2 Summit for the last two years, and now we're returning the favor for their meeting. Basically, we're making a great meeting even better. Like we're two kids (more like grown ups) holding hands as we cross over the intersection of Educational Avenue and Cutting Edge Clinical Science Boulevard.

CardioSource has full coverage of TCT’s major trials. 

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Please note that statements or opinions expressed herein reflect the views of the contributor, and do not reflect the official views of the ACCF, unless otherwise noted. 

This post is by Christopher M. Kramer MD, FACC, from the Departments of Medicine and Radiology, University of Virginia Health System, in Charlottesville, Va.

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Gadolinium-based magnetic resonance contrast agents (GBCA) have been used for well over two decades and more than 200 million patients have received them safely. In the early part of the last decade, a dermatologic condition was recognized in dialysis patients known as nephrogenic systemic fibrosis (NSF), a progressive induration of the skin that also can involve internal organs and is often fatal as there is no specific therapy.

Soon thereafter, gadolinium was noted in skin biopsies of some of these patients and an association between the use of these agents for MRI and NSF was made. In 2006, the FDA issued a warning in regards to the use of GBCA in patients with severe chronic kidney disease (CKD). These agents are cleared by the kidneys with an elimination half-time in patients with normal renal function of approximately 1.5 hours, but up to 34 hours in patients with severe CKD (stage 4/5) or acute kidney injury. With prolonged circulation times, gadolinium can then become unchelated and it is in this form that it becomes potentially toxic to tissues. The incidence is quite low, with an estimation of 4.3 cases/1000 patient-years. One review of over 83,000 patients in the U.S. identified 15 (0.02%) with NSF and these patients got a higher than standard dose and many of them had acute renal failure at the time. The disease has not been identified in patients with milder forms of kidney disease (stage 1-3).

CGCA included gadodiamide (Omniscan), gadopentetate dimeglumine (Magnevist), gadoversetamide (OptiMARK), gadoteridol (ProHance), gadobenate diglumine (MultiHance), Eovist (gadoxetate disodium) and Ablavar (gadofosveset trisodium). The first 3 listed above are older agents and have been implicated in more of the historical cases, in part because of the frequency of their use and in part because their chelatation of gadolinium is less tight. However, the FDA states that none of these agents can be considered safe as all have been implicated with cases of NSF.

Since the FDA warning in 2006, clinicians have been avoiding the use of these agents in patients with CrCl<30, using the lowest possible doses for MR studies, and avoiding repeat studies in these patients. The number of cases of this disease has fallen to a nearly negligible level. However, on Sept. 9, the FDA required a change in labeling of all gadolinium-based agents that goes beyond their previous warning in an attempt to minimize the future risk of NSF. The labeling will simply suggest that health care professionals should screen patients to identify those at risk (stage 4/5 CKD or acute kidney injury) and avoid use in these agents. This change is primarily cosmetic, as the recognition of this disease and the FDA warning are each more than 4 years old and has already resulted in changes in practice that have limited the scope of the problem.

UPDATE (9/30): CVN Video

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Please note that statements or opinions expressed herein reflect the views of the contributor, and do not reflect the official views of the ACCF, unless otherwise noted.

I spoke at an event earlier today with with ACC President and blog co-author Ralph Brindis, MD, FACC, and ACP CEO John Tooker, MD, MBA. ACC's write up on the event follows:

The American College of Cardiology (ACC) and The Hill hosted Sen. Tom Coburn (R-Okla.) and Rep. Brian Baird (D-Wash.) for a discussion on physician payment reform on Capitol Hill. The event highlighted ACC efforts to lead the way in payment reform by creating better models of care for patients and using innovative tools for enhanced quality management. The speakers said the solution isn’t about putting more money into the system or getting more money for physicians -- it is about payment reform from a patient-centered point of view. The goal, the speakers emphasized, is to change the current system, described by them as one that rewards mediocrity and quantity and doesn’t listen to patients, with one that encourages physicians to spend time with patients and rewards excellence, efficiency and quality of care. 

The ACC currently has several tools to help with quality management including five hospital-based registries and a practice-based one that helps participating facilities and other medical professionals identify and close gaps in quality of care; reduce wasteful and inefficient care variations; and implement effective, continuous quality improvement processes. There is also the Door to Balloon (D2B) and Hospital to Home (H2H) initiatives focused on reducing the door-to-balloon times in U.S. hospitals performing primary PCI and reducing cardiovascular-related hospital readmissions and improving the transition from inpatient to outpatient status for individuals hospitalized with cardiovascular disease.

Check out this Thomas Friedman New York Times op-ed on the state of the US, using educational status as a barometer of national prominence. It makes a scary point about being #11 among 100 best nations in the world according to Newsweek. OK, I don't worship Newsweek; nor am I down on the future of America. But diagnosing our reality honestly is key to improving our future. And I think Friedman is right on about a major predictor of our destiny -- our competitiveness in educating our next generation(s) as compared to other developed (and developing nations!). We're not doing well. And apathy and self-centeredness is a major part of it he contends.

Could we be Number 11 in health care soon? We definitely still have the most sophisticated and well-trained health care workforce in the world, and we have the best access to the latest technology and evidence-based care. But we're definitely far from Number 1 (maybe number 30?) in overall population based health status, in large part a result of socioeconomic and lifestyle factors and uneven access to the best care. The numbers of uninsured also contributes heavily.

Quite frankly, our next generation of health care workers will be adversely affected if we allow an ongoing mediocrity in our educational system. And, we could downgrade our health care status independently by undermining the future of health care by cheapening it down under the rubric of health reform done poorly. We need health reform to regain our rightful #1 overall status in health care -- including in population based health status -- but it needs to be done right, and it needs resources. Most importantly, health reform needs the leadership of physicians and the health professions over the very critical next several years. There will be political roller coasters to ride. But, let's not be apathetic, folks. That makes us victims, rather than leaders. Carpe Diem!

This post is from ACC Fellow in Training Justin Bachmann, MD, who attended the 2010 Legislative Conference earlier this week.

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Washington is something of an old friend.  I had the chance to get well-acquainted with the city during my Internal Medicine training at Johns Hopkins Hospital.  Now a Cardiology fellow at UT-Southwestern Medical Center in Dallas and the Fellow in Training representative for the Texas Chapter of the ACC, I return to DC several times a year.  This was my first year at the ACC Legislative Conference, and I was exceedingly impressed.  The ACC staff has clearly put a lot of work into helping us advocate for our profession through the most effective channel – as constituents.

I arrived at the Fairmont Hotel on Sunday afternoon.  The ACC Political Action Committee was kind enough to host a happy hour for Fellows in Training on Sunday night.  I had a chance to catch up with several other fellows that I met on the interview trail back when I was a resident.  The highlight of dinner that night was the Capitol Steps performance.  The Capitol Steps are an improv group known for their scathing wit, and every elected official is fair game.  The Pelosi/Reid tag team skit was particularly hilarious.

The next morning we got down to business.  The Texas delegation had a good turnout.  I sat with Dr. David May, the Texas chapter President, Dr. Rick Snyder, the immediate past President and Dr. George Rodgers, a former chapter President.  One of my fellow colleagues from San Antonio, Dr. Oscar Bailon, was also present.  The day started with an update on the legislative arena by ACC CEO Dr. Jack Lewin and the ACC advocacy staff.  Dr. Lewin then spoke about the effects of the recent CMS rule on cardiology practices throughout the nation, including trends towards hospital integration and the increasing strain on private practices.  I’d be lying if I said the picture was anything but bleak.

Luckily, we learned that Rep. Charlie Gonzalez (D-TX), one of cardiology’s most ardent supporters, was planning on introducing legislation to require that reimbursement cuts be phased in gradually instead of being implemented immediately.  Together with his prior legislation designed to reverse the severe cuts to cardiology services, Rep. Gonzalez’s efforts represent our profession’s best chance at protecting ourselves from the recent CMS rule.  Dr. Brindis fittingly honored the Congressman with the President’s Award for Distinguished Public Service later that evening.  Rep. Gonzalez received a standing ovation, and deservedly so.

Our appointments on the Hill on Tuesday started off in Kenny Marchand’s (R-TX) office.  We to moved on to visit with the staff of Pete Sessions (R-TX), Eddie Bernice Johnson (D-TX), Michael Burgess (R-TX), Silvestre Reyes (D-TX), and Solomon Ortiz (D-TX).  It’s clear that everyone is concentrating on being reelected and issues such as the sustainable growth rate (SGR) won’t be tackled so close to election day.  However, most of the offices seemed receptive to signing on to Rep. Gonzalez’s new legislation.  

As I look back on the Legislative Conference on my way home to Dallas, I’m grateful that the ACC has a highly motivated advocacy staff that is working to protect our legislative interests.  I’m particularly grateful to Dr. May and Dr. Snyder, with whom I spent the day on Tuesday during my Hill visits.  Dr. May and Dr. Snyder have been incredibly supportive of fellows in Texas and are skilled advocates for the profession.  I appreciate their mentorship and guidance.  Hopefully by next year Rep. Gonzalez’s legislation will be signed into law.  Either way, I’ll certainly plan on visiting the Hill with my colleagues from Texas in 2011.