CardioExchange Archive

To celebrate the holiday season, CardioExchange asked several of our contributors to choose the 3 most important cardiology-related events of the past year and to make 3 predictions for 2011.

Looking back at 2010:

1. Dabigatran, which has been released, and the other oral thrombin inhibitors, which will be released: Imagine, we finally have  a replacement for warfarin, in the appropriate situations. For the patients (and ignoring the cost for the moment), it will be a big improvement — no blood testing, no dietary changes, and take just two pills a day with no adjustments.

2. The Patient Protection and Affordable Care Act, of course. The PPACA is still a work in progress and will be for years to come. But, it will induce and implement the biggest changes in cardiology and general medical practice since Medicare started.

3. The Midei case, or the general governmental scrutiny of excessive use, fraud, and abuse: Cardiology especially has an opportunity here. While the outcome of cases like this could greatly injure our profession, we have a chance to turn defeat into victory. Appropriate-use criteria, professional accreditation of cardiac cath labs, and data-driven improvements in the inpatient and outpatient settings can effectively show our high level of professionalism. A very large, super-majority of us practice this daily and constantly.

Predictions for 2011:

1. The PPACA will not be overturned. It will be implemented in various-sized bits and pieces over the next several years.

2. Cost cuts, requirements to implement EHRs, and other governmental actions will drive even more groups into employed status.

3. The Hospital to Home (H2H) national quality improvement initiative, led by the American College of Cardiology and the Institute for Healthcare Improvement, will be a big success.

To celebrate the holiday season, CardioExchange asked several of our contributors to choose the 3 most important cardiology-related events of the past year and to make 3 predictions for 2011.

Looking back at 2010:

• ACGME releases new work hour rules. Although these new guidelines are not specifically focused on cardiology training, they promise to impact all cardiologists in teaching facilities. The long-term impact of these changes will take years to fully understand, but are likely to continue the erosion of professionalism and competence among trainees.
• Aldosterone antagonists continue their winning streak with EMPHASIS-HF. With this trial, indications for aldosterone antagonists have been extended to milder forms of heart failure due to LV systolic dysfunction. The consistency of benefit with regard to hard outcomes with this class of agents is remarkable and challenges clinicians to identify appropriate candidates for treatment.
• The merging of cardiology practices with hospitals. Interestingly, relatively modest changes in reimbursement, rather than health care reform legislation, appears to be responsible for the incredible changes in the cardiology private practice landscape.

Predictions for 2011:

• The end of the independent practitioner. The momentum towards marriages of practices with hospitals will continue and the last solo practitioner will close shop Dec 31 2011. Then, in 2012 the divorces will begin—this is America after all!
• Increasing focus on the harm we cause with unnecessary radiation exposure. A cardiologist will be sued by a patient who develops a malignancy following multiple questionable cardiac procedures involving radiation.
• Conflict of interest is taken up by the lay media and public. Increasing focus is placed on inherent conflicts of interest arising from fee-for-service medicine.

To celebrate the holiday season, CardioExchange asked several of our contributors to choose the most important cardiology-related events of the past year. Barry Massie has focused on heart failure, providing us with his choice of the four most important stories of 2010.

1. Aldosterone antagonists continue their winning streak: Following the convincing reductions in mortality and morbidity with spironolactone in severe heart failure (NYHA class III/IV) in the RALES trial and in the EPHESUS trial with eplerenone in patients with acute MI and LV dysfunction, we saw similar striking reductions (37%) in the composite of cardiovascular death or heart-failure hospitalization in the EMPHASIS trial. Each of these studies was conducted on top of excellent medical therapy, suggesting that aldosterone blockade should be considered earlier in the management of patients with LV systolic function.

2. Migrating cardiac resynchronization therapy (CRT) into milder heart failure: A similar “trifecta” was achieved with CRT this year. Two previous trials, REVERSE and the much larger MADIT-CRT trial, convincingly demonstrated that CRT can improve LV function and induce “reverse LV remodeling” in patients with QRS width ≥120 or 130 msec, respectively, and these changes were associated with a reduction in clinical outcomes (heart-failure worsening and all-cause mortality). RAFT (Resynchronization/defibrillation trial for Ambulatory Heart Failure Trial) randomized 1,798 patients with NYHA II or III heart failure, impaired LV function, and wide QRS to implantation of an ICD or ICD/CRT device, with the addition of CRT resulting in a 26% reduction in the primary composite endpoint of all-cause death or heart-failure hospitalization.

3. Remote monitoring to improve heart-failure outcomes: It seems intuitive that close monitoring of heart-failure patients in clinics or by telephone or other remote techniques can prevent heart-failure worsening by facilitating early intervention; however, the substantial literature on this topic is inconsistent and non-convincing, reflecting heterogeneity of results and, likely, publication bias. Two randomized, controlled trials presented at the AHA meeting (Tele-HF and TIM-HF) compared telephone-based monitoring with usual care, and neither had a favorable effect on its primary outcome (all cause readmission and death in the former and mortality in the latter). How can we explain this result? Successful heart-failure management is complex and requires an involved and adherent patient, reliable and timely information transfer, and timely and appropriate intervention by knowledgeable, experienced practitioners. This may be too much to expect!

4. The ASCEND Trial (presented at AHA 2010): Nesiritide, a recombinant form of B-type natriuretic peptide, was approved in 2001 for the treatment of hospitalized patients with acute heart failure (AHF) on the basis of several relatively small trials that demonstrated modest improvement in dyspnea. It was marketed aggressively as the “first new drug for AHF in a decade,” with sales rapidly rising to an annualized rate of $1 billion. However, two meta-analyses suggested a possible increase in mortality and worsening renal function. The ASCEND trial enrolled 7,141 AHF patients, who were randomized to usual care or nesiritide. The active drug produced a marginal improvement in dyspnea at 6 and 24 hours, but though nominally statistically significant, it did not meet the prespecified threshold for positivity. The secondary endpoint of 30-day death or heart-failure readmission was non-significantly lower with nesiritide. Thus, nearly 10 years after its approval, ASCEND demonstrated that nesiritide was safe but had limited benefit in AHF patients.

To celebrate the holiday season, CardioExchange asked several of our contributors to choose the 3 most important cardiology-related events of the past year and to make 3 predictions for 2011.

Looking back at 2010:

1. The PARTNER Trial demonstrated the efficacy of transcatheter aortic valve implantation for patients deemed too high risk for conventional cardiac surgery.  This intervention will be a game-changer for the treatment of patients with aortic stenosis, but raises mind-boggling questions about where and by whom the procedure should be performed, proper case-selection, cost-effectiveness, self-referral…the questions go on and on.

2. The Symplicity HTN-2 trial showed that catheter-based renal denervation safely and effectively reduces blood pressure. Imagine an effective once-and-for-all treatment for hypertension.

3. The DEFINE Trial showed phenomenal effects of a cholesteryl ester transfer protein (CETP) inhibitor, anacetrapib, on LDL and HDL levels. One can only hope that larger trials will show that this drug is safe and improves cardiac outcomes.

Predictions for 2010:

1. We will see meaningful payment reform that will fairly reimburse providers, properly align incentives, and finally create incentives to provide value in health care spending.

2. The American College of Cardiology will work with payers to develop a practical and scalable mechanism to implement at the point-of-care test ordering for imaging tests using the Appropriate Use Criteria.

3. Observational studies from prospective registries and administrative databases will demonstrate that interventional cardiologists, acting responsibly and professionally, perform the vast majority of coronary stent procedures appropriately. We will find that the alleged overuse of stents by the Maryland cardiologist is an aberration and that generalizing from this egregious case to create sweeping criticisms of the interventional cardiology community is unwarranted.

To celebrate the holiday season, CardioExchange asked several of our contributors to choose the 3 most important cardiology-related events of the past year and to make 3 predictions for 2011.

Looking back at 2010:

1. By far, the number one heart story of 2010 was the release of the novel blood-thinning drug, dabigatran (Pradaxa), for the prevention of stroke in atrial fibrillation (AF). Until this October, the only way to reduce stroke risk in AF was warfarin — the active ingredient of rat poison. Assuming that there aren’t any post-market surprises, Pradaxa figures to be a true blockbuster. Doctors and patients have waited a long time to say goodbye to warfarin.

2. The Mark Midei stent story: Whether Dr. Midei is guilty or innocent of implanting hundreds of unnecessary stents isn’t really the big story. The real impact of this well-chronicled saga is the attention that it brings to the therapeutic misconceptions of coronary stenting. The problem with squishing and stenting is that although they improve the physics (of blood flow), they do not change the biology of arterial disease — a hard concept to grasp when staring at a picture of a partial blockage. The vast press coverage of Dr Midei’s alleged transgressions has served to educate many about this nation’s number-one killer, heart disease.

3. The percutaneous (non-surgical) therapy of valvular heart disease. Presently, the only effective means of treating valvular heart disease is open-heart surgery — the most invasive of invasive. Percutaneous approaches to both the mitral valve and the aortic valve made news in 2010. Of the two, transcatheter aortic valve implantation (TAVI) is farther along. The PARTNER Trial showed that patients with severe aortic stenosis who were not suitable for surgery fared better with TAVI than with medical therapy. That the PARTNER Trial was non-negative means that further investigations into percutaneous approaches to valvular heart disease will continue in earnest. Here’s a real-life vignette to illustrate why non-surgical treatment of valvular heart disease is exciting:

He is an “old” 82; thin, grey-haired, and he keeps coming in for breathlessness and chest pain related to severe aortic stenosis. That dang valve just will not open. He lives alone, but barely; he has a walker, and a scooter for the grocery. His mind is sharp and his disposition good. “I can’t handle surgery…I know that, but I am happy…Can you help me?” he asks. Perhaps in the future, we can fix his aortic valve without a saw.

Predictions for 2011:

1. A pill or surgery will never effectively treat obesity. Take that one to the bank!

2. Coronary stents will surpass ICDs in regulatory oversight. And on a more general note, due to our utilization of expensive imaging studies and costly implantable devices, cardiologists will be increasingly burdened by the take-the-fun-out-of-medicine regulators.

3. The therapy of AF will stay on the front page of heart news. Expect another (perhaps two) dabigatran-like warfarin substitute(s) for stroke prevention in AF. Also, especially from me, expect more good news on catheter ablation of AF.

To celebrate the holiday season, CardioExchange asked several of our contributors to choose the 3 most important cardiology-related events of the past year and to make 3 predictions for 2011.

Looking back at 2010:

1. Effects of CYP2C19 Genotype on Outcomes of Clopidogrel Treatment: Ten years after the initial decoding of the human genome, we felt we finally had a genetic test and a drug with clinical applicability. However, this study and others cast doubt on the ability to predict response to anti-platelet therapy, demonstrating that we still have a lot to learn in order to develop individualized medical therapy.

2. Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery: I choose this paper because it has the potential to represent a paradigm shift and offers an entirely new therapy to patients. It is exciting to think about this as a natural progression of the advances that interventional cardiology has made in the past forty years.

3. Exposure to low-dose ionizing radiation from medical imaging procedures: It is always a good thing when studies provoke controversy, but these two studies in JACC and Circulation reminded us of the potential harm we can do to patients even with “non-invasive” imaging.

Predictions for 2011:

1. Now that there is published and presented literature on dabigatran, rivaroxaban, and apixaban, 2011 could represent a seismic shift away from warfarin. Or will physicians and patients want to learn more about these medicines before leaving the known for the unknown?

2. As health care reform continues to gather pace, expect more trials to be published aimed at decreasing costs and hospitalizations such as the telemonitoring in heart failure research that was presented at AHA this past November.

3. With the large number of studies looking at hypertension management in diabetics, such as ACCORD BP, it will be interesting to see if the JNC-8 guidelines due to be published in 2011 will have dramatically new recommendations.

To celebrate the holiday season, CardioExchange asked several of our contributors to choose the 3 most important cardiology-related events of the past year and to make 3 predictions for 2011.

Looking back at 2010:

1. PARTNER: Transcatheter aortic valve implantation significantly improved symptoms and reduced mortality in patients with severe aortic stenosis who were not candidates for surgery. The treatment of valvular heart disease is forever changed.

2. RAFT: CRT when added to an ICD reduced heart failure hospitalizations and reduced mortality in an easily identified group of patients with heart failure.
We can indeed identify patients in whom device therapy is highly effective.

3. DEFINE: The increases in HDL and reductions in LDL were quite impressive, with no apparent off-target toxicities. If the clinical outcome trial looks as good, anacetrapib will be a major breakthrough in cardiovascular medicine.

Predictions for 2011:

1. Increased focus on health care costs, which will nevertheless continue to increase. De facto rationing will start to emerge (though it will not be called that).

2. Increased scrutiny of appropriateness of cardiology procedures and cardiac imaging. Will paradoxically lead to many cases of inappropriate underutilization of these technologies.

3. Further consolidation among cardiology practices and hospitals. Solo cardiology practice will continue to disappear and more cardiologists will become employees of hospitals; costs will rise, not fall.