Latest Trials from AHA on Stem Cell Therapy: A Glimmer of Hope for the Future

A number of hot trials have been coming out of AHA’s meeting in Los Angeles over the past few days, including several with positive results that underscore the future of cardiology and stem cell therapy.

Results from the POSEIDON trial indicate that transendocardial injection of allogeneic and autologous mesenchymal stem cells (MSCs) without a placebo control were both associated with low rates of treatment-emergent serious adverse events, including immunologic reactions in patients with left ventricular (LV) dysfunction due to ischemic cardiomyopathy. In addition, results from the ALCADIA trial suggest that transplantation of autologous cardiac-derived stem cells (CSCs) with controlled release of basic fibroblast growth factor (bFGF) is both safe and effective in treating injured human hearts with reconstruction of the post-ischemic environment. While the SCIPIO trial results suggest that infusion of autologous CSCs harvested from the left atrial appendage at the time of coronary bypass surgery in patients with ischemic heart failure is safe and beneficial in both ventricular function and myocardial viability. These effects are sustained at 2 years and improve over time (read the full CardioSource article here). Whether these exciting new observations are sustained in a larger cohort of patients remains to be determined in future studies.

These innovative advances in stem cell therapy offer opportunities to cure, not just treat, patients with cardiovascular disease, and show how far we’ve come over the past decade since the first application of stem cell transplantation occurred in 2000 involving heart failure therapy. Phase I and Phase II trials have since indicated that it is both feasible and safe for physicians to isolate stem cells and to transplant them. Results however on improvement in ventricular function, viability and outcome have been mixed. Researchers are going back to the bench to gain more insight into the basic and molecular mechanisms of stem cells to improve the potential clinical effectiveness of this approach and also concurrently looking at the best methods of stem cell types and delivery. Among the methods being tested are direct epicardial injection, intravenous infusion and endocardial delivery. However, no single method has emerged as a major winner or standard.

One thing is certain, we will continue to see this hot topic emerge in future meetings (including ACC.13 in San Francisco) and publications as the science rapidly evolves and as we look for novel and more definite cures for heart failure in our patients.

Visit CardioSouce.org for additional AHA 2012 meeting coverage. Also, be sure to follow @ACCinTouch on twitter for the most up-to-date news coverage.

Andddd That’s a Wrap

As we wrap up ACC.12 after soaking in all the new and best cardiovascular science and education, I’m continuously amazed at how much progress is made from these meetings. Over the past few days I’ve both presented with and had the honor to learn from some of the most astounding cardiovascular health care innovators in the field. Now the challenge lies in taking what we’ve learned and implementing it – and, as Immediate Past President David Holmes, MD, noted in his ACC.12 Opening Session address, using it to transform how we provide care to patients and work in partnership with others.

With the recent two year anniversary of the Affordable Care Act (ACA) and the start of the Supreme Court hearings of the constitutionality of it all, I’d be remiss not to also mention the timely discussions that took place throughout ACC.12 on health care reform and its impacts on everything from health IT, to imaging, to academia, to the future.

Yesterday I gave the presentation, “ACA for Dummies,” giving a play-by-play of the ACA’s nine separate independent titles, as part of a session that looked at where cardiology will be as a profession in 2015. The bottom line is even if the decision is to rid of the ACA we will still be faced with immense access, cost and quality problems. Our goal at the College is to ensure that we’re poised to help ensure these changes put patients first and reward physicians and other medical professionals for their commitment to quality and evidence-based care.  Congress’ traditional cost reduction strategies of price controls and caps on spending — as in the broken SGR (or sgrrrr, expressed as a growl) Medicare payment formula — just won’t work. Instead we need to systematically improve care.

Also yesterday, I was on a progressive panel discussion about the Future of Cardiovascular Diseases: Where Are We Going (and Where Do We Want to Go?) with ACC’s new President Bill Zoghbi, MD, President-Elect John Harold, MD, Million Hearts Director Janet Wright, MD, and others, which discussed the recent UN Summit on NCDs, and others initiatives to combat the growing epidemic of cardiovascular disease. I think Huon Gray, MD, said it best: “Since CV disease knows no boundaries with regards to the patients it affects, nor should the organization and cardiologists whose job it is to help them.”

Professionalism has to be a part of our changing future and the patient must be the center. We have to change the physician/patient relationship and move toward patient centered care, something that Zoghbi is focusing on during his presidential year. We’re not just embracing change, we need to lead change!

Overall it was a great meeting, folks and thanks to everyone who made the journey to the Windy City. Save the Date for ACC.13, March 9-12 in San Francisco!

PS the fun never stops here on Hollywood on the Potomac, check out my testimony before a House Appropriations subcommittee here where I was able to discuss the need for more funding for cardiovascular disease research (just like what was presented at ACC.12), prevention and treatment.

ACC.12 Blog Round Up – Day 4

In case you missed it, check out the coverage from Day 4 on the FIT Blog featuring videos on ACC.12 Closing Remarks, FITs on the GO Bloopers, Words of Wisdom for FITs, Interventional Cardiology at ACC.12, Coffee Break, Tweeting Away, FIT Forum IV, “Word on the Street” Parting Thoughts and Favorite Sessions, exclusive interviews with Dr. Antonio Columbo, Dr. Maya Guglin, Dr. Christopher Liu, Dr. Raymond Gibbons, Dr. William Boden, and more! To view all of the FIT coverage of ACC.12 visit CardioSource.org/FIT.

In addition, special blog coverage of ACC-i2 with TCT is available on TCTMD.com with topics like Structural Heart Disease from the “Right” Side, A Decade of Drug Eluting Stents, and more! (Must have a free login to view the posts).

New PCI vs. CABG Trial Results Are One More Reason to Involve Patients in Care Decisions

This post was authored by William J Oetgen, MD, MBA, FACC, ACC’s senior vice president of Science and Quality.

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Results from the ASCERT study released today during the final Late-Breaking Clinical Trial session found that patients who underwent PCI had a higher death rate in the first four years after treatment than those who had opted for coronary artery bypass graft (CABG) surgery. The study, which used combined patient data from the ACC’s CathPCI Registry, the Society of Thoracic Surgeons CABG database and the Medicare claims database, suggests better survival in patients undergoing CABG compared to PCI.

While past studies have suggested that the two treatments have similar long-term outcomes, others have shown better outcomes with CABG. Patents and doctors tend to choose the less-invasive PCI when both treatments are an option. Recently updated ACCF/AHA Guidelines for CABG and PCI state that PCI to improve patient survival is a reasonable alternative to CABG in stable patients with left main CAD who have a low risk of PCI complications and an increased risk of adverse surgical outcomes. The guidelines also confirm the superiority of CABG compared to medical therapy and to PCI for most patients with 3-vessel disease.

Should physicians start recommending CABG over PCI as a result of this study? The answer is no. A major limitation of observational studies, such as this one, is that the groups may not have the same level of risk, and so it is possible that the worse outcomes in the PCI patients were related to these patients being sicker overall. These results do, however, underscore the importance of the Guideline-recommended “heart team” approach to determine which procedure should be used. This approach means that the interventional cardiologist and the cardiac surgeon review the patient’s condition, determine the pros and cons of each treatment option, and then present this information to the patient, allowing him or her to make a more informed decision. Results from studies like ASCERT should be shared with patients as part of the decision-making process.

Read more on the study here.

A Personal Perspective on the Year Ahead

I am deeply honored and humbled to take on the leadership of the ACC and further its mission to transform cardiovascular care and improve heart health. This is an exciting, yet challenging, time for the field of cardiology. Our capacity to diagnose and treat heart disease has never been greater. Yet, the sobering fact is that heart and vascular disease remain the leading cause of death around the globe. Equally sobering, the current U.S. health care system is not sustainable.

As a result of these factors, my presidential year will focus on furthering patient-centered care, a style of care that emphasizes educating and involving patients in medical decision making; integrating medical care, and applying principles of disease prevention and behavioral change. The patient is indeed at the center of all ACC activities and of what we do as cardiovascular professionals, be it in clinical practice, administration or research.

It’s easy to be enthusiastic about innovations in research and treatment, but we need to be equally enthusiastic about a future in which, fewer people develop cardiovascular disease in the first place. My challenge to each and every member of the cardiac care team is to be an advocate for health, not just for medicine; to be committed, but adaptable; to get involved and be an advocate for patients; to be collaborative and stretch boundaries; and be educators and mentors.

I look forward to serving the College during the next year. This is a time of transformation: new stages in our careers, new challenges in our practices. Our task is to envision better possibilities and turn them into reality. Whatever comes to fruition over the next 12 months and beyond, will be a credit to the longstanding and often unrecognized labor of many individuals. I look forward to identifying the possibilities and shaping the future of cardiovascular care, together.

ACC.12 Blog Round Up – Day 3

In case you missed it, check out the coverage from Day 3 on the FIT Blog featuring exclusive video interviews with Dr. Christopher Kurtz, Dr. Sunil Rao, Dr. Blair Erb, Dr. Robert Frye, Dr. Scott Lilly, Drs. George Dangas and Christopher Granger, Dr. Justin Bachmann, Drs. Mauricio Cohen and William O’Neill, and Dr. Thomas Porter; ACC.12 in 1-2 Words, “Word on the Street” videos on the ACC.12 Buzz, Late Breaking Clinical Trials, International Edition, FIT Thoughts and the Clinical Decision Making Sessions, and FIT Meeting Highlights.

In addition, special blog coverage of ACC-i2 with TCT is available on TCTMD.com with topics like Bioresorbable Vascular Scaffolds, Emerging Technologies, The CYP2C19 Debate Lives On, 19 ways for DAPT, Cells best used elsewhere… and more. (Must have a free login to view the posts).

Joint Session BSC and ACC: NICE Guidelines

This post was authored by Sarah Clarke, MD, FACC, vice president of Education and Research for the British Cardiovascular Society.

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Interesting joint session of the British Cardiovascular Society (BCS) and ACC, chaired by Drs. Iain Simpson of BCS and John Harold, vice president of the ACC, comparing and contrasting process of establishing guidelines in the UK vs. US.

The National Institute of Clinical Excellence (NICE) in the UK not only recommend on clinical evidence but also on cost effectiveness. In terms of implementation, the final decision rests with Commissioners. Whilst NICE was established to reduce postcode medicine, unfortunately uptake of guidance can vary by Commissioner. Commissioning in the UK is increasingly being devolved more locally. The UK has access to several guidelines- those from NICE, ESC and ACC. The BCS endorses the European Society of Cardiology (ESC) guidelines as these are based solely on clinical evidence.

It was felt that guidance in the US was less stringent than Europe and led to more variability in practice. Patient involvement in guidelines was discussed. In the UK patients are represented on guideline committees and it is felt invaluable to keep the panel focussed on the patient! In a cash strapped NHS patients are able to be rational in assessing additional benefits of new drugs especially where cost implications are concerned.

The NICE stable angina and ACS guidelines were reviewed in brief and compared to ESC and ACC guidelines as an illustration.

It was interesting to compare the approval process for clinical research studies in the UK vs. the US where it is particularly protracted. The process is being streamlined in the UK.

Overall it was a well-attended, informative session.

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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.

For more information about ACC’s International Activities visit the International Center on CardioSource.org.

ACC.12 Blog Round Up – Day 2

In case you missed it, check out the coverage from Day 2 on the FIT Blog featuring exclusive video interviews with Drs. Patrick O’Gara and Rick Nishimura, and Dr. Thomas Porter; “Word on the Street” videos on FIT Meeting Highlights, FIT Thoughts and the Clinical Decision Making Sessions, Posters and Heart Songs, Advice for Fellows, ACC.12 and FITs, and FIT Forum III; audio interviews with Dr. Clyde Yancy, Dr. Daniel Lee, and Dr. Michael Lincoff; and blog posts on CardioCompass and live Twitter coverage from sessions. For more FIT coverage of ACC.12 visit CardioSource.org/FIT.

In addition, special blog coverage of ACC-i2 with TCT is available on TCTMD.com with topics like How much would you pay for more time? Cells best used elsewhere…, Transulnar access: worst of both worlds? How to use sheathless catheters for radial interventions when they are not FDA approved? How to decrease the cost and risk of a transeptal puncture by 30%, and more. (Must have a free login to view the posts).

The Future of ACC’s Registries

This post was authored by John Rumsfeld, MD, FACC, chief science officer and chair of the NCDR.

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Since the launch of the ACC’s National Cardiovascular Data Registry (NCDR), it has become the preeminent cardiovascular data repository in the U.S. with six hospital-based registries and the nation’s largest practice-based registry, the PINNACLE Registry. Providing evidence based quality improvement solutions for cardiologists and other medical professionals, these registries are gathering extensive data with participation from more than 2,200 hospitals nationwide.

This year’s annual NCDR meeting was a huge success bringing in over 800 professionals representing all registry roles and experience levels, including registry site managers and data coordinators, nurses, physicians, quality improvement professionals and technical personnel.

Looking ahead, it is increasingly clear that clinical registry programs like NCDR will play a fundamental role in the future of cardiovascular care around the globe.  Registries such as the IMPACT Registry, which focuses on the management and outcomes of pediatric and adult patients with congenital heart disease undergoing cardiac catheterization procedures, and the STS/ACC TVT Registry, which tracks patient safety and real-world outcomes related to TVT procedures, are examples of ways the NCDR is growing to address new areas of cardiovascular practice in the U.S.

Meanwhile, international interest in registries for research and tracking purposes can go a long way towards identifying research opportunities, as well as areas for global improvement. Interest in the NCDR by countries like Saudi Arabia, Abu Dhabi, Brazil and Japan are indicative of the global effort to address heart disease.

International collaborations are key to the future of the ACC’s Registries and through these efforts we can use common data standards to understand quality of care internationally and to find ways to work together to improve systems of care and research.

ACC.12 attendees should check out the session, Transforming Health Care Delivery through CV Registries on Monday from 3:45 – 5:15 p.m. in McCormick Place North, N427. Also this year 29 abstracts based on NCDR data were presented. Stop by booth 10027 to pick up a copy of the Abstract Guide.

Here’s my interview with CardioSourceVideoNews:

Better Information and Better Outcomes Through Health IT

This post was authored by Farzad Mostashari, MD, ScM, deputy national coordinator for programs and policy within the Office of the National Coordinator for Health Information Technology at the U.S. Department of Health and Human Services.

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When I talk to people about why the Obama Administration is investing billions of dollars in health information technology (IT) I tell them it’s not about technology, it’s about helping improve care and outcomes through better information.  To be sure, a first step in that process is increasing adoption of electronic health record systems (EHRs), which has more than doubled over the past two years to 34% among all office-based physicians and 35% at acute care hospitals.

But just as important is the need for providers who have EHRs to use them in meaningful ways, which is what the HITECH Act is really trying to achieve.  Just like a piano is not much use if no one ever plays it, EHR are worthwhile only if providers use them to help deliver high quality care and improve health outcomes.  Meaningful use means using EHRs to help clinical information follow patients through the care process, coordinate care among providers, and better manage chronic diseases, as well as enabling patients to become more engaged in their own care.  Meaningful use of certified EHRs also provides information tools that cardiologists and other providers need in order to succeed in a delivery system that is increasingly rewarding high quality care rather than high quantity care.

Given the prevalence of cardiovascular disease in the United States, it is particularly important that cardiologists embrace advanced information technology.  So far more than 2,500 cardiologists have successfully attested to Meaningful Use, collecting nearly $45 million in Medicare incentive payments.  Congratulations to those who have achieved Meaningful Use – I’m greatly encouraged by your success!  But I also know there’s plenty of room for these numbers to grow.  The ACC has committed to getting 8,000 of its members to Meaningful Use by the end of the year.  It’s an ambitious goal, but it’s also achievable and I look forward to reaching (or even surpassing) it in the months ahead.

The proposed rules for Stage 2 for the Medicare and Medicaid EHR Incentive programs, and accompanying EHR certification, aim to move the Incentive programs forward in a balanced, impactful way.  Among the proposed changes, providers will have more ways of reporting quality measures, including registries, and there will be greater alignment among quality reporting measures among HHS programs.  The standard for exchanging clinical information will be more robust than Stage 1 and more emphasis will be placed on making information available to patients.  Providers will also no longer be required to purchase certified EHR systems that perform functions which they don’t need in order to achieve Meaningful Use – that means EHRs can be more geared to specific specialties and still qualify for incentive payments.  We’d love to get your input on these rules, so I would strongly encourage members of ACC to submit comments on the two proposed rules through May 7.

I am also pleased to recognize the winners of the Investing in Innovation initiative’s (i2) One in a Million Hearts Challenge, which asked multi-disciplinary teams of innovators to create technology applications that activate and empower patients to pursue healthy lifestyles and improve their heart health. The i2 initiative utilizes prizes and challenges to facilitate innovation and obtain solutions to intractable health IT problems.  The winner of the One in a Million Hearts Challenge is Team THUMPr, which will be awarded $50,000. The second and third place teams, mHealthCoach and Wellframe, will be awarded $20,000 and $5,000, respectively.

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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.

For more information about Health IT visit CardioSource.org.