Last week the members of the Congressional Joint Select Super Committee struck out as expected, sending the stock market back down to levels lower than they were a decade ago (read more about the Super Committee in a previous blog post here).

Under the law that created the bipartisan 12-member panel, the failure of the Super Committee means the government will face an across-the-board $1.2 trillion cut to defense and non-defense spending in 2013.  Medicare provider payments will be reduced by 2 percent in 2013 unless Congress finds substitute reductions.

After the finger pointing behaviors were satisfied, the Super Committee pointed out that no deal is better than a bad deal, which is true. Since the process of the automatic sequestration does not kick in until Jan. 1, 2013, it’s the current craziness on Capitol Hill leading up to the Nov. 2012 election that will ultimately predict where the economy is headed.

Unfortunately, Jan. 1, 2013 has a double whammy attached to it: sequestration if Congress does not come to a deficit reduction plan before then; and the Bush tax cuts automatically expire. Together, these dual automatic actions would reduce deficit development by over $4 trillion annually. Both of these politically charged issues are of concern to both parties -- but rigid differences in how they would address the issues could prevent Congress from acting on them.

Meanwhile, the fate of the looming cuts due to the SGR (or SGRrrr, the un-Sustainable Growth Rate Medicare physician payment formula expressed as a growl), which go into effect on Jan. 1, 2012, remains very tenuous. I predict that Congress will enact a 2-year delay in the next month to avoid having this issue return again on the politically charged Jan. 1, 2013 date; but Congress will also want to prevent disruptions in Medicare access to senior voters before the election. Still, nothing in this fractious environment is easily predictable.

One thing’s for certain, we need to work to make sure Congress focuses its immediate attention on preventing the SGRrrr cuts before the end of the year!

Join me, ACC President David R. Holmes, Jr., MD, FACC, Advocacy Steering Committee Chair Jerry Kennett, MD, FACC, and ACC Senior VP of Advocacy James Fasules, MD, FACC, for an All-Member Year-End Webinar sponsored by the PINNACLE Network. The webinar will provide valuable information on how the failure of the super committee will impact cardiology and will offer next steps to addressing the SGR crisis leading up to Jan. 1, 2012. The webinar takes place on Thursday, Dec. 1 from 7-8 p.m. EST. Click here to register.

Tobacco use continues to be the leading preventable cause of disease and premature death in the U.S. As such, there are many targeted efforts at the local, state and federal levels to not only educate consumers about the health risks related to tobacco use, but ban its use in public places. The new Million HeartsTM initiative, in which the ACC is a partner, lists smoking cessation as key element in reducing one million heart attacks and strokes over the next five years. Just this last week the ACC and its CardioSmartTM National Care Initiative took part in the American Cancer Society’s Great American Smokeout campaign.

At the state level, great strides have been made to enact smoke-free legislation. In fact, in my home state of Mississippi we are making headway in reaching our goal of passing a statewide smoke-free law. The Mississippi State Department of Health is undertaking a major project funded by the Centers for Disease Control and Prevention called “Smoke-Free Air Mississippi.” As a board member of the State Board of Health, I had the privilege a few weeks ago of working with the health department and State Health Officer, Dr. Mary Currier, in presenting information on the success of this project. Even though the state as a whole is not yet smoke-free, most of the major Mississippi communities are smoke-free. In fact, 80 percent of Mississippi adults and more than 50 percent of Mississippi smoking adults favor a law prohibiting smoking in most public places.

I personally like some of the slogans from the campaign: "Every child deserves to breathe smoke-free air;" "Breathing smoke is not on any job description;" "Breathing is not optional—smoking is.” Communities with casinos have been hard nuts to crack, and the restaurant industry was initially a main opponent to the project, but once several prominent restaurateurs invoked no smoking rules in their restaurants, they actually saw their business improve. This was especially true for family-focused restaurants. Now many restaurants are strong supporters of ordinances in their community, as well as the goal of a statewide smoke-free law.

Do smoke-free laws improve health? Surely they do, and the data are impressive.  A study from Mississippi State University involving three hospitals, including my own, showed that during the 900 to 1,000 days following implementation of the smoke-free ordinance, there was a 27 percent reduction in one community and a 14 percent reduction in another in heart attack admissions. To me this is incredible information since it even shows the short-term effects of active and passive smoking.

Currently, there are twenty-nine states, DC, Puerto Rico and the U.S. Virgin Islands, plus numerous cities and counties that have enacted smoke-free laws. The National Conference of State Legislatures, of which the ACC is a Foundation Member, has compiled a map (current to November 2010) of states that have indoor smoke-free laws. This is a key issue that the ACC State Advocacy team follows, and they will continue to work with ACC members and stakeholders to pass laws that support smoke-free environments.

I congratulate all of the states and communities that have enacted smoke-free laws, and I have hope that one day it will become the law of the land!

As the recent Guidelines for Secondary Prevention for Patients With Coronary and Other Atherosclerotic Vascular Disease recommend, “[e]very tobacco user should be advised at every visit to quit.” The single most important thing that clinicians can do is to encourage patients to stop smoking. CardioSmart has several useful resources available online for patients looking to quit, and is supporting the National Cancer Institute’s SmokefreeTXT program, geared toward teens and young adult smokers.

An interesting study from the New England Journal of Medicine on weight-loss techniqueswas presented this morning at the AHA’s Scientific Sessions in Orlando. The Practice-Based Opportunities for Weight Reduction (POWER) trial examined theeffectiveness of weight-loss programs in obese patients with high bloodpressure, high cholesterol, or diabetes. Outpatient treatment of obese patients at risk of heart disease has been a struggle for physicians everywhere and alternative, convenient solutions that encourage weight-loss and a healthy lifestyle are much needed.

The goal for patients in the 24-month long study was to lose five percent of initial weight within six months. Two methods were explored: one with in-person health coaches and one driven by technology where patients were counseled on weight reduction over the phone. Both methods engaged primary care physicians as an integral part of the support team. The study found that patients who received information over the phone were equally as likely to lose weight and keep it off as patients who met directly with coaches.  Fifty three percent of patients enrolled in the phone driven program, which also had an interactive website component, achieved their goal. This outcome has the exciting potential to change the way weight-loss programs are developed and delivered in the future, increasing patient access to essential counseling and tools.

I will be excited to follow the impact this study will haveon patient access, especially in my home state of Mississippi. Given the high obesity rates of the South and the increasing rates across the country, effective solutions for weight-loss are greatly needed andhave been an ongoing struggle to develop. The results of the POWER trial can open the doors to a whole new way to treat overweight patients at risk for heart disease.  This trial demonstrates that information can be disseminated to a wide-range of patients not only nationally, but also globally, using common communications channels.

Finding innovative and flexible weight-loss education programs is key. Here at the College, we identified the importance of patient education several years ago with the launch of CardioSmart, which has been a successful initiative to get out in the community and promote a healthy lifestyle. NASCAR Track Walks that couple fitness with entertainment have been a huge hit and create the foundation for making smart choices. The Health and Wellness Center on CardioSmart has a section devoted to diet and exercise, providing patients with the tools and information they need to reduce their risk of heart disease. The Walk With a Doc program featured in the latest issue of Cardiology is another successful grassroots program that has seen tremendous success ininspiring and educating patients. Thinking outside the box and finding practical solutions to problems we encounter every day can truly impact the care and outcomes of our patients.  

Atrial fibrillation (AFib) is the most common sustained cardiac rhythm disturbance, increasing in prevalence with age. It is often associated with structural heart disease, although a substantial proportion of patients with AFib have no detectable heart disease. Hemodynamic impairment and thromboembolic events related to AFib result in significant morbidity, mortality, and cost.

Several of the Late-Breaking Clinical Trials coming out of the American Heart Association’s (AHA’s) 2011 Annual Meeting focused on new treatments for this common condition, particularly in high-risk patients.

Among the results:

• Video-assisted epicardial surgical ablation was found superior to catheter ablation in high-risk patients with enlarged atrial and hypertension, or unsuccessful prior catheter ablations. However, the adverse event rate for surgical ablations was higher. Read more about the FAST trial here.

• Radiofrequency catheter ablation (RFA) worked as well as or better than antiarrhythmic drug therapy as first-line therapy in patients with paroxysmal AFib. The study found that at 24 months AFib burden, occurrence of AFib and symptomatic AFib were significantly lower with RFA. Read more about the MANTRA-PAF trial here.

• Dronedarone was found to be unexpectedly dangerous in some patients with permanent AFib in the PALLAS trial. Researchers stopped enrollment in the trial in July when the Data and Safety Monitoring Board detected excessive serious vascular events and deaths. The drug has been shown to reduce unplanned hospital admissions and death in patients with non-permanent AFib. This was the first trial to investigate interventions in morbidity and mortality in high-risk patients. Read more about the PALLAS trial here.

As the health care world continues to focus on improving care and reducing costs, new trials, like those above, are crucial to the continued evolvement of how to best prevent and treat this condition. New drugs and therapies, if used appropriately, can offer some real solutions. The ACC continues to work with partners like AHA, the European Society of Cardiology and the Heart Rhythm Society (HRS) to follow these and other trial results, and provide cardiovascular providers with the best, evidence-based guidance on how to manage AFib patients. Updated AFib guidelines were released earlier this year. The ACC and HRS are also partners in the “Atrial Fibrillation Community” on CardioSource.org, which provides latest news and updates, discussions on hot topics and more. In addition, ACC.12 in Chicago this next March will offer additional opportunities to explore the latest scientific advances when it comes to AFib.

The ACC presidential team will be in full force over the next few days at the American Heart Association (AHA) annual meeting in Orlando, Florida. The meeting is sure to be full of new and exciting science, and the team will be attending an array of meetings and receptions in order to network and connect with leaders from the other domestic and international cardiovascular organizations.

Dr. Holmes and I already attended a meeting with leaders from AHA, the European Society of Cardiology (ESC) and the World Heart Federation (WHF) to discuss the ongoing issues as addressed by the recent United Nation’s high-level meeting (read about the UN meeting in a previous blog post here). There’s still a lot of work to be done, but we’re committed to work together to fight this growing global crisis.

Dr. Holmes and I also met with leaders from the Venezuelan Society of Cardiology (VSC) to discuss upcoming opportunities between our two organizations. The ACC recently launched its newest international chapter at the VSC’s annual congress. VSC President Nedina Mendez was instrumental in creating the Venezuela Chapter, which has appointed Bartolome Finizola, MD, FACC, as its representative. The Chapter has already enrolled all cardiovascular trainees as FIT members of the College as a unique benefit. Venezuela is just one of the many countries from the South America region who have expressed interest in joining the ACC.

The ACC’s NCDR^® (National Cardiovascular Data Registry) has 14 abstracts that will be presented during the meeting, which can be viewed here. At the recent ESC meeting in Paris, King Abdulaziz Medical City (KAMC) became the newest international participant to join the NCDR’s CathPCI Registry^®.  KAMC is the second international NCDR participant after Sheikh Khalifa Medical City in Abu Dhabi joined the CathPCI Registry and ACTION Registry^®–GWTG™ earlier this year.

This week is bound to be an exciting week full of new opportunities and innovation, so be sure to stay up-to-date with the ACC’s coverage of the meeting on CardioSource.org and visit the meeting coverage page for trial summaries, slide sets, video coverage and comments.

Also be sure to follow the ACC on Facebook and Twitter for the latest breaking news and for video coverage and photos of the meeting.

If you are attending the meeting in Orlando, be sure to stop by ACC’s Booth 1308 to learn about the latest news from the College including ACC.12 in Chicago.

I am in San Francisco today and speaking about the state of cardiovascular medicine at the CRF's TCT 2011 conference. Here is a snapshot of what I will be discussing:

The trend in U.S. health care is simple: spending is drastically rising. U.S. health care expenditures total more than $2.5 trillion. In the past few decades, hospital, physician and prescription drug expenditures have also been steady to rise. Medicare spending for cancer and heart disease varies greatly – with heart disease still almost double cancer spending even though new hope to someday become take second place in morbidity, mortality and spending. Heart disease spending Medicare alone is projected at about $220 billion in 2011 and will rise to well over $300 billion or more by 2020. Health care spending in the U.S. is more than double that of other developed nations – and health care is the primary driver of future federal spending and the accumulating deficit. With more than 35 million U.S. citizens and 15 million non-citizens uninsured, 50 million on Medicare and 40 million on Medicaid, it is clear that the spending incurred by the American health system is a heavy burden to the nation unless the profession moves in to reduce unnecessary spending.

Baseline demand of physicians is sharply outpacing the baseline supply as medical school enrollment and choice to practice a medical specialty decline. Practices are changing as more than 38 percent surveyed by the ACC in 2010 are either already integrated or considering hospital integration and 14 percent are merged or considering a merger with another practice. Well over 50 percent of CV private practices have sold to hospitals or other employment venue and the trend continues.  It is clear that this is a time of change for CV medicine and health care at large. Practice transformation will be affected by the bullish forces promoting integration, payment reforms, delivery system reform that requires team practice and advanced health information technologies, more informed patients who will engage in shared decision making, public reporting on quality and efficiency, and pressures to use clinical data and feedback to systematically improve quality and value, and to reduce variation and disparities.

Socioeconomic Trends and Imperatives

Stunning technology and infrastructure, a superbly trained workforce, excellent academic institutions, leading innovation – these are hallmarks of the U.S. health care system which currently covers more than 84 percent of Americans with private or public health insurance. Unfortunately, that also means that 16 percent of Americans are uninsured, and the nation is saddled with skyrocketing costs, great variation in quality of care and lack of needed care coordination. Clearly our non-system is in great need of mending. While the embattled Affordable Care Act offers new opportunities to promote access, insurance reform, and prevention, while also adding new funding to stimulate innovation, research,  public health and work force development, it’s fate is uncertain. In this chaotic environment, CV medicine  faces major uncertainties in terms of the impacts of system reform and deficit reduction on the future attractiveness and viability of CV physician practice,  the availability of primary care, and the affects of delivery system reforms and funding changes on patient care.  

While uncertainties abound, the future of health care and CV medicine can be positive influenced by the use of registry data and quality improvement programs which more consistently deliver best evidence at the point of care. ACC’s NCDR® and PINNACLE registries; Hospital to Home, Door-to-Balloon,  and Imaging in FOCUS initiatives, and other quality improvement programs will greatly improve outcomes and  reduce unnecessary spending if they can diffused more widely and include primary care. The ACC is poised to help the nation solve the problems of uneven quality, poor care coordination, and skyrocketing costs in health care through these and other efforts and partnerships.

To emulate management guru Peter Drucker, “The best way to predict the future is to create it.” Let’s get on with it. 

For more information on ACC’s quality initiatives, visit http://www.cardiosource.org/qualityprograms.

Today was a big day for late-breaking clinical trials related to transcatheter aortic valve replacement (TAVR) at TCT 2011. Three separate trials addressed the following: PARTNER Cohort B Two-Year, PARTNER Cohort A Quality of Life, and PARTNER Cohort A Cost-Effectiveness.

In addition, results from the STACCATO trial were also released. This trial focused on implantation of the Edwards Sapien transcatheter aortic valve, which was recently given the green light by the Food and Drug Administration (FDA). The STACCATO trial was designed to include 200 relatively low-risk patients, but was halted after enrollment of 70 patients by the Data Safety and Monitoring Board. However, the trial results suggest that transapical TAVR in its current stage of development should be restricted to high-risk patients, and that use in patients who are otherwise good operative candidates may not be in the patient’s best interest. It must be remembered that we have not seen the final data, it has not been subjected to peer review, and the results must be considered in light of other data available. There are multiple issues to be considered including patient selection, operator experience as well as experience of the whole team.  This data provides the rationale of continuing to optimize strategies of care for these patients, with optimal selection and optimal procedural performance.

The results of these trials continue to underscore the necessity for specialty societies like the ACC and the Society of Thoracic Surgeons (STS), the FDA, the Centers for Medicare and Medicaid Services and industry to work together as we move forward with TAVR. Patient selection and provider training will be key. It also underscores the necessity of the new ACC/STS TVT Registry™ scheduled for release later this year. Backed by the registry expertise of the ACC’s NCDR^® and the STS National Database, the TVT Registry will serve as the main repository for clinical data related to TAVR and is positioned to capture outcomes data for expanded indications, additional devices and procedures that will likely emerge in the future. The goal of the registry is to link clinical and administrative claims data to assess early and longer term outcomes. The registry also forms the basis of a new platform that can be used for FDA post approval studies in future generations of transcatheter valve devices.

This is an exciting time for interventional medicine and as president of the ACC, I’m proud of the collaborative work we are doing to make sure that this transformational new therapy is appropriately used. Hopefully the lessons learned from TAVR will serve as a new paradigm for other devices and drugs developed in the future.

Keep up with all of the TCT 2011 coverage on CardioSource.org.

This week, I am joined by David Holmes, Bill Zoghbi, Ralph Brindis and interventional cardiologists, radiologists, clinical cardiologists, scientists, vascular medicine specialists, surgeons, nurses and others interested in interventional and vascular medicine in San Francisco for CRF’s Transcatheter Cardiovascular Therapeutics Conference—also known as TCT. This year marks the first time ACC is co-sponsoring the symposium and we have been working closely with CRF throughout the year to share content and distribute educational materials. Last year, a “Collaboration Council” of senior physician leaders was formed to set the strategic direction of the partnership in order to accomplish the joint goal of expanding educational opportunities for interventional cardiovascular professionals.

During this year’s conference, over 20 late-breaking clinical trials will be presented, with several that have the potential to significantly impact clinical practice. Results from RAPID GENE, one of the most ground-breaking trials at TCT, were presented this afternoon.  One of the limitations of pharmacogenetic strategies has been the inability to perform rapid genetic testing at the patient’s bedside in the hospital. Currently, costs, a lack of local genetic testing expertise and the inability to provide timely information have been impediments to the application of genetics. As a result, a prospective evaluation of the personalized approach to anti-platelet therapy after PCI based on genetic data has not been possible. This late-breaker evaluated the first point-of-care genetic test in medicine for its accuracy and potential clinical utility by looking at Prasugrel vs. Clopidogrel in CYP2C19*2 carriers.

CYP2C19*2, a common genetic variant, is associated with an increased occurrence of major cardiovascular events following percutaneous coronary intervention (PCI). The innovative point-of-care genetic test, Spartan RX-CYP2C19, used in the study enabled carriers of the genetic variant to be identified within 60 minutes after a buccal swab.

CYP2C19*2 carriers in the rapid genotyping group who were  administered prasugrel saw a significant reduction in the primary endpoint (0%) relative to the standard therapy group (clopidogrel) (30.4%) (p=0.009). The study also found a significant reduction in the percentage of platelet inhibition in carriers from the rapid genotyping group compared to the standard therapy group (73.3% vs. 27.0%, p<0.001).

The authors of the study found that the point-of-care genetic testing device proved feasible in a clinical setting and that it facilitates rapid personalization of anti-platelet therapy. Given these outcomes, we are sure to see larger scale studies that will evaluate the role of pharmacogenomics after PCI in the future.

Keep on the look-out for coverage of other noteworthy trials, including TRIGGER-PCI, BRIDGE, RIFLE STEACS, STACCATO and TWENTE throughout the week.  If you’re in San Francisco for TCT this week, make sure to stop by the ACC’s table in the CRF Collaboration Pavilion on the Lower Level Concourse of Moscone North Hall. I hope to see you there!

For complete coverage:

• Visit the TCT meeting page on CardioSource.org
• Follow ACC on Twitter and Facebook 
• Join the Interventional CardioSource Community
• View the video on RAPID GENE and BRIDGE Trials

The past few weeks have been quite busy in the world of guidelines with the release of the revised American College of Cardiology Foundation (ACCF), American Heart Association (AHA) and the Society for Cardiovascular Angiography and Interventions (SCAI) guideline for percutaneous coronary intervention (PCI); the ACCF/AHA guideline for coronary artery bypass graft surgery (CABG); and a new ACCF/AHA guideline on the diagnosis and treatment of Hypertrophic Cardiomyopathy. Lastly, an update to the AHA/ACCF guideline for Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and Other Atherosclerotic Vascular Disease was also published.

Under the direction of Alice Jacobs, MD, FACC, chair of the ACCF/AHA Task Force on Practice Guidelines, a Process Improvement Group was initiated two years ago to review guidelines and implement changes in response to comments that the scientific guidelines should be more user-friendly at the point of care. According to Jacobs, the overarching goal of our guideline effort is to maintain relevance and ease of use at the point of care while guiding evidence-based clinical practice. The PCI guideline piloted several new initiatives including a focus on replacing and limiting text with evidence/summary tables and highlighting recommendations with their level of evidence and supporting references in color tables.

In addition, for the first time, a combined a section on revascularization was crafted together by the PCI and CABG writing committees for ease of use by the clinician.  Members from the ST-segment elevation myocardial infarction (STEMI), PCI and CABG Writing Committees worked together to draft recommendations that overlap multiple guidelines during a Consensus Conference in an effort to shorten the development time and maintain concordance.

There were also several important updates in the guidelines, including a new concept of a “heart team” approach in the combined PCI and CABG section on revascularization to determine which procedure should be used. This approach involves an interventional cardiologist and a cardiac surgeon reviewing a patient’s condition, determining the pros and cons of each treatment option, and then presenting this information to the patient, allowing him or her to make a more informed decision.

I welcome your feedback about these new guidelines below or join the discussions on the CardioSource Communities pages.

To learn more about the guidelines, read the CABG guideline “10 Points to Remember” and the PCI guideline “10 Points to Remember” CardioSource journal scans. Full text of the guidelines for PCI, CABG, Hypertrophic Cardiomyopathy, and Secondary Prevention and Risk Reduction Therapy are available online and will be published in JACC.

This post was authored by Michael Chernew, PhD, who sits on the Editorial Panel for the ACC/AJMC Community on Payment Innovations and is a MedPAC Commissioner.  Dr. Chernew's views, however, are his own and do not represent those of ACC, AJMC or MedPAC. 

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A lot has been written of late about the Sustainable Growth Rate (SGR) system.  One point of consensus appears to be that the system is not sustainable. It needs to be repealed.  The controversy surrounds what to do after the repeal.  Ideally, the physician payment system of the future would promote beneficiary access to high quality care and be fiscally sustainable. 

The estimated 10 year cost of replacing the SGR with a freeze in physician fees is over 300 billion dollars.  Replacement with a fee schedule that is adjusted for inflation would be even more costly and options to finance the costs are limited.  Debt financing seems impossible given out current fiscal situation.  An increase in taxes is possible, but seems politically infeasible.  Without taxes or deficit spending, funding an SGR fix requires cuts from elsewhere in the budget, including elsewhere in Medicare. 

The recent MedPAC recommendation assumed financing entirely from Medicare, though MedPAC did not necessarily endorse financing exclusively from Medicare.  This exercise illustrates how difficult financing is.  MedPAC was only able to offset a fraction of the 300 billion dollars by accumulating a series of cost saving measures that affect a wide range of providers and beneficiaries.  Because the offsets were incomplete, cuts in physician fees were still needed to avoid increased Medicare spending.  With constraints against raising taxes or debt financing, alternatives are limited.  Tweaks to payment around the fee-for-service framework are unlikely to achieve significant score able savings and unlikely to pave the way to the health care system we deserve. 

Shifting costs to beneficiaries is possible.  In fact, reform of the benefit design to encourage judicious use of care and improve cost consciousness among patients can improve efficiency and help fund an SGR fix.  This benefit redesign should be a part of the solution; however, it is not clear how much could be saved through such redesign and it is unlikely to be the sole foundation of a solution.  Changes to benefit design will certainly raise serious concerns about equity, access and quality depending on how such a shift is implemented.  In the meantime, payment reform must be addressed.

A way out of the world characterized by the grim fee trajectory remains, but it requires a change in business model.  In addition to the payment proposals, MedPAC offered recommendations that support new delivery models.  Even with the recommended fee cuts, the projected payment per beneficiary rises.  If providers can capture the overall revenue, control rising volumes and eliminate waste (which most agree is significant), high quality care can be coupled with financial success.  Clearly, such a transition will not be easy and evidence that providers can be successful is emerging, at best.  The regulations necessary to guide such a system are still being developed and far from perfect.  Yet the alternative, as the MedPAC recommendations illustrate, is not appealing.  Getting on with the task of reforming the whole system seems the only way forward.

Additional Resources:

• Community on Payment Innovations
• How much savings can we wring from Medicare?
• SGR Issue Brief