ACC.12 Blows Into the Windy City

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Tens of thousands of cardiologists descended in Chicago, March 24-27, for the 61st annual American College of Cardiology (ACC) scientific session & expo to learn about the latest research and network with peers. Below are highlights of a few presentations.
     

Cards disagree on potential for cell therapy in ischemic heart patients

Cardiologists wrangled over whether or not the FOCUS trial, despite its inability to reach the pre-established primary endpoint, indicates promise for the future of cell therapy in patients with ischemic heart disease who do not have other therapeutic options.  

Emerson C. Perin, MD, PhD, from Texas Heart Institute in Houston, and his colleagues conducted this double-blinded, randomized, multicenter trial for the transendocardial delivery of a dose of 100 million autologous bone marrow mononuclear cells (BMCs) in patients with chronic ischemic heart disease and LV dysfunction with heart failure and/or angina.

Between April 2009 and 2011, researchers at five sites randomly selected 92 patients to receive stem cell treatment or placebo (61 patients received BMCs, compared with 31 who received placebo). Perin et al found that LVEF increased by a small, but significant amount (2.7 percent), in patients who received stem cell therapy. The study also revealed that the improvement in ejection fraction correlated with the number of CD34+ and CD133+ cells in the bone marrow—information that will be helpful in evaluating and designing future therapies and trials, according to the researchers.

However, based on the original study primary endpoints, there were no significant differences at baseline and at six months. “If we had picked an endpoint of LVEF, we would have had a positive study,” Perin said during his presentation. “This is a very sick population for whom we have no available treatments, and the ongoing stem cell therapy research could provide us with an option.”

While all the study discussants deemed the trial “very important,” some were hesitant to accept the researchers’ positive interpretation of the results. Robert M. Califf, MD, of Duke University Health System in Durham, N.C., classified FOCUS as “a resoundingly negative study, not just a somewhat negative study.”

Docs discuss beef with healthcare reform bill

The Patient Protection and Affordable Care Act has been debated and discussed ad nauseam, but how will the bill actually impact doctors? According to Richard E. Anderson, MD, chairman and CEO of The Doctors Company, ultimately the bill will increase demand yet offer no break in terms of supply or professional liability.

A major hurdle will be the push to curb the practice of defensive medicine. "What’s missing in the bill in terms of professional liability? Everything,” Anderson added.

“This is a 2,500-page bill and there are only one or two mentions of professional liability reform,” Anderson said. “The ones that are in the bill are exclusionary.”

However, he said that there is a section (Sec. 10608), which extends federal malpractice protection to “nonmedical persons at free clinics.” While Anderson said that this is great in terms of enhanced protection, “the real question is why aren't we all protected?”

He noted other major issues within the current legislation,including:
  • It provides new standards of care. “The legal system works backwards from the outcome, and poor outcomes are subject to litigation, period.”
  • It will increase demand, with no change in supply. “The supply of physicians is not going to change dramatically despite the fact that in 2014 we will have 32 million new participants in the healthcare system;” and
  • The enormous complexity and unknown nature of the reform could hurt practice with “botched handoffs, disjunctions in care and unmet expectations.”
A major problem will be the fact that current bill language says, “nothing in this bill should be construed to establish new standards of care for medical malpractice litigation,” said Anderson.

However, he noted malpractice is a huge issue that forces physicians to practice defensive medicine. “Ultimately, when you get into any situation that limits healthcare, you are forced to defend the negative.”

CCTA safely expedites ED discharge

Coronary CT angiography (CCTA), as the first test for low- to intermediate-risk patients presenting to emergency departments (ED) with potential acute coronary syndrome, results in safe and expedited discharge from the emergency department of many patients who would otherwise be admitted, according to the late-breaking clinical trial, ACRIN PA.

In this Phase IV trial, the researchers randomly assigned 1,370 patients at five centers to traditional “rule-out” care (462 patients) or CCTA (908 patients) in a 1:2 ratio. Providers at each site made all decisions about tests and treatment for the traditional care group patients on an individual basis.

The CCTA group followed a three-part protocol: tests to measure blood levels of two substances associated with heart damage and risk of heart attack or stroke, CCTA and discharge if test results were negative.

Of 640 patients with a negative CCTA examination, none died or had an MI within 30 days. As compared with patients receiving traditional care, patients in the CCTA group had a higher rate of discharge from the ED (49.6 vs. 22.7 percent); a shorter length of stay (median, 18 hours vs. 24.8 hours); and a higher rate of detection of CAD (9 vs. 3.5 percent). There was one serious adverse event in each group.

Researchers found no significant differences in 30-day resource utilization between the CCTA and traditional care arms—but the percentages were consistently higher for the CCTA arm.

Predictors of post-TAVI mortality revealed

Non-cardiac co-morbidities, such as chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD), atrial fibrillation and frailty, are main predictors of late mortality after transcatheter aortic valve implantation (TAVI), suggesting that patients with these conditions merit closer evaluation and follow-up, according to the longest multicenter study on the clinical outcomes and valve durability with TAVI.

Josep Rodés-Cabau, MD, from the department of cardiology at the Quebec Heart & Lung Institute in Quebec City, and colleagues included 339 patients considered to be inoperable or at very high surgical risk who underwent TAVI at six Canadian medical centers between January 2005 and June 2009. The transfemoral approach was used in 48 percent of the patients, while the transapical approach was used in 52 percent of the patients. The STS score for all patients was 9.8 percent—9 percent in the transfemoral arm and 10.5 percent in the transapical arm.

After the median three-year follow-up, 43.1 percent of the patients had died. Also, 10.4 percent of those patients died within 30 days of TAVI, and 32.4 percent died during the remainder of the follow-up period. Of those who died more than 30 days post-procedure, 67.3 percent died because of non-cardiac causes, 26.4 percent died of cardiac causes, and the cause of death was unknown in 7 percent of the patients.

After examining the long-term data from those who died more than 30 days post-procedure, researchers determined that death was most often caused by COPD, CKD, atrial fibrillation and frailty.

The causes of cardiac death at follow-up were cardiac failure (65.6 percent), sudden death (13.8 percent), MI (13.8 percent), endocarditis (3.4 percent) and post-mitral replacement (3.4 percent).

In summary, performing TAVI in this patient population was associated with a survival rate of 57 percent after a median follow-up of three years, with no differences between transfemoral and transapical approaches.