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April 4th, 2011

STICH Illuminates CABG in Heart Failure, Finally

After a very long wait, the Surgical Treatment for Ischemic Heart Failure (STICH) trial has finally shed light on the common but poorly understood use of CABG in heart failure patients with ischemic heart disease. The results were presented by Eric Velazquez at the ACC and published simultaneously in the New England Journal of Medicine.

Some 1212 patients with an ejection fraction of 35% or less and coronary artery disease were randomized to medical therapy plus CABG  or medical therapy alone. At 56 months’ median follow-up. the death rate (the primary endpoint of the study) was 41% in the medical therapy group versus 36% in the CABG group (HR with CABG: 0.86, CI 0.72-1.04, p=0.12).

  • Cardiovascular death occurred in 33% of the medical therapy group versus 28% of the CABG group (HR 0.81, CI 0.66-1.00, p=0.05).
  • The rate of death plus hospitalization for cardiovascular causes was 68% in the medical therapy group versus 58% in the CABG group (HR 0.74, CI 0.64-0.85, p<0.001).

Some 100 patients in the medical therapy group ended up having CABG during follow-up; 555 patients in the CABG group actually underwent surgery.

With the exception of 30-day mortality, secondary clinical outcomes favored CABG. As expected, CABG resulted in an early risk, so that for the first 2 years after randomization the risk for death was higher in the surgical group.

The investigators had initially planned to enroll 2000 patients, but slower than desired enrollment led them to adjust the trial, so that fewer patients were followed for a longer period in order to accumulate enough endpoints.

The authors cautioned that “when the analysis in any trial fails to detect a significant difference between treatment groups with respect to the primary outcome, analyses of secondary outcomes showing a benefit must inevitably be considered to be somewhat provisional.”

STICH Myocardial Viability Substudy

A myocardial viability substudy of STICH was presented immediately following the main study and was also published simultaneously in the New England Journal of Medicine. First author Robert Bonow said that physicians often use myocardial viability tests to determine whether patients with coronary artery disease and LV dysfunction should undergo CABG, but that this strategy has never been tested.

In the substudy, 601 patients who had already undergone myocardial viability testing were randomized to either medical therapy plus CABG or medical therapy alone. The death rate was 37% among the 487 patients with viable myocardium and 51% among the 114 patients without viable myocardium (HR for patients with viable myocardium, 0.64, CI 0.48-0.86, p=0.003). However, this association lost all statistical significance after adjustment for other baseline characteristics.

The authors write that their results indicate “that assessment of myocardial viability alone should not be the deciding factor in selecting the best therapy for these patients.”

Editorial

James Fang, in an accompanying editorial entitled “Underestimating Medical Therapy for Coronary Disease … Again,” writes that patients like those enrolled in the STICH trial should receive aggressive medical therapy and that revascularization “should be carefully weighed but can be safely deferred,” though it should be offered to those with “persistent or progressive symptoms.”

For more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup.

April 4th, 2011

MitraClip Compared with Surgery in EVEREST II

The final results of the highly anticipated  EVEREST (Endovascular Valve Edge-to-Repair Study) II  were presented by Ted Feldman at the ACC Scientific Sessions in New Orleans and published simultaneously in the New England Journal of Medicine. Some 279 patients with moderately severe or severe mitral regurgitation (MR) were randomized on a 2:1 basis to either percutaneous repair with the experimental MitraClip device or conventional surgery for repair or replacement of the valve.

At 1 year, compared with patients in the MitraClip group, patients in the surgery group were significantly more likely to be free of death, surgery for mitral-valve dysfunction, or grade 3+ or 4+ MR at 12 months (the primary efficacy endpoint of the trial): 55% in the MitraClip group versus 73% in the surgery group (p=0.007). Here are the rates for the individual components of the primary endpoint:

  • Death: 6% in each group
  • Surgery for mitral-valve dysfunction: 20% with the MitraClip versus 2% with conventional surgery
  • Grade 3+ or 4+ MR: 21% versus 20%, respectively

Both groups had improvement in the severity of MR following treatment, but the improvement was significantly greater in the surgery group. At 30 days, the rate of major adverse events was 15% with the MitraClip versus 48% with surgery (p<0.001). About one-fourth of patients in the MitraClip group had significant MR prior to hospital discharge and were referred for surgery.

The authors summarize their results: “We found that although percutaneous treatment was effective at reducing mitral regurgitation, surgical treatment was more effective, as graded by an echocardiographic core laboratory. However, percutaneous treatment was associated with a reduction in the rate of major adverse events at 30 days, as compared with surgery, and with sustained clinical improvement, as measured by quality of life, heart failure status, and left ventricular function.”

In an accompanying editorial, Catherine Otto and Edward Verrier write that “ideally, any new procedure would also be at least equivalent to surgical valve repair in terms of safety, valve function, durability, and long-term outcomes.” The MitraClip, they write, “fulfills some, but not all, of these criteria.” They note that the introduction of new minimally invasive devices poses a challenge to the traditional model in which the cardiologist usually decides whether a patient should be referred for surgery. “This approach breaks down as more options for intervention become available,” they write. They propose, in response, a “patient-centered approach to decision making” that would require “a true consensus of experts” following a review of each case.

For more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup.

April 3rd, 2011

The Cardiology Profession: At the Table or on the Menu?

Several Cardiology Fellows who are attending ACC.11 this week are blogging together on CardioExchange. The Fellows include Sandeep Mangalmurti, Hansie Mathelier, John Ryan (moderating and providing an outsider’s view from Chicago), Amit Shah, and Justin Vader. See the previous post in this series, and check back often to learn about the biggest buzz in New Orleans.

After a quiet day settling in yesterday, I was very excited to begin my first ever ACC national conference. So far, it has not disappointed. The day began with a rousing multimedia presentation and the national anthem; if only my regular fellowship days began with such a punch! The theme of the morning’s introductory remarks was not the science of cardiovascular disease, but rather the profession of cardiology and the broader social and policy context within which it operates. As someone who is just beginning his journey as a cardiologist, understanding this context is an essential element of a successful career.

The first major address of the introductory session was the Franz M. Groedel Presidential Plenary Lecture, delivered by Dr. James Orbinski, former international president of Doctors without Borders (Medecins Sans Frontieres). He recounted his experiences in Africa with AIDS patients, as well as victims of the Rwandan genocide. As one would expect, the focus was not on the details of their health care. Rather, Dr. Orbinski’s teaching point was that to truly help your patients, you must become engaged in the larger policy infrastructure that shapes the way you practice and the therapies you can offer. Of course, he is absolutely correct; physicians can never shut our exam room door and “just take care of our patients.”  In today’s environment, most of the decisions regarding that care will happen before the patient even sets foot in the clinic or hospital. This interdependence is particularly pronounced in developed countries with austere practice environments. Kindness and clinical skills are ineffectual without the medicines and other resources to provide care; only political involvement and advocacy can provide those resources, and providers must be part of that process.

Of course, the vast majority of those at ACC 2011 will never travel overseas with Medecins Sans Frontieres. However, we are still not off the hook, as emphasized by the next speaker, ACC President Dr. Ralph Brindis. His focus during his tenure as ACC President has been on professionalism, and for him, it is inextricably linked to being good stewards of the profession. We are one of the few professions that is allowed to regulate itself, a privilege we have earned through decades of dedication to values that transcend our financial and professional self interest. As our practice environment and resources become more austere (though hopefully not approaching those of developing nations!), we must continue to show why we continue to deserve that trust. In this turbulent time of health-care reform and need for cost effectiveness, change is inevitable. As cardiologists, we can help shape this change, before it shapes us. Or as Dr. Brindis put it, we can either be “at the table or on the menu.”

How does the profession of cardiology stay off the menu? Our contribution to this debate is our understanding of clinical medicine, and our access to data regarding outcomes, quality, and utilization. Neither the public nor public leaders have this skill set, and they need physicians to help them make sense of the growing sea of information on quality and cost effectiveness. We can help them by continuing to promulgate rigorous evidence-based guidelines, and publish accurate data on clinical outcomes and performance metrics.

Dr. Brindis found one regulatory mechanism worthy of particular mention: developing a culture of appropriate use. One particularly corrosive failure of cardiology is the growing perception that many in the field may be performing unnecessary tests or procedures merely for reimbursement. One recent episode of The Dr. Oz Show asserted that 50% of PCIs are unnecessary. The recent accusation against interventional cardiologists at St. Joseph’s Medical Center in Maryland does little to undermine that perception. The speaker also mentioned a recent JAMA article which asserted that more than 22% of ICD placements were non-evidence based. The accuracy of these assertions will continue to be debated by the experts, but all cardiologists have a role in helping to gather evidence and data to help answer to these questions. The continued development of utilization and practice pattern databases is yeoman’s work that we must all share, but where the profession may be falling short.

No discussion of the upcoming changes in cardiology would be complete without a discussion of the recently passed health-care bill (The Patient Protection and Affordable Care Act of 2010). I was eagerly anticipating the discussion today by Dr. Robert Kochner, a special assistant to President Obama, regarding the implications of this Act on the practice of cardiology. He was, unfortunately, unable to attend, but we still received an illuminating discussion of the topic from Dr. Brindis, Dr. Richard Kovacs (outgoing chair of the ACC Board of Governors), and Dr. Jim Fasules (Senior VP, Advocacy and Policy, ACC)  The contour of the debate continues to shift, and is currently dominated by the discussion of the country’s deficit burden, but the ACC’s legislative goals have remained constant: expanded access, maintenance of a private health-care system, improvement of quality of care, and payment reform. How and if the new legislation meets these goals remains to be seen; these questions will take years to answer. In the interim, the ACC continues to push for 3 major legislative changes (in additional to its baseline advocacy for the profession): 1) a permanent solution to the sustainable growth formula for Medicare, 2) tort reform, 3) continued protection of reimbursable in-office imaging.  (For background on the ACC and medical imaging, see here.)

For more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup.

April 3rd, 2011

2-Year Outcomes of the RESOLUTE All Comers Trial

The Resolute zotarolimus-eluting stent (ZES) is now starting to demonstrate good long-term results. At an interventional featured clinical study session at the ACC in New Orleans and in a simultaneous publication in the Lancet, Sigmund Silber and colleagues presented the 2-year findings of the RESOLUTE All Comers trial comparing the ZES with the Xience V everolimus-eluting stent (EES) in a broadly representative patient population. Previously, the 1-year results had shown that the ZES was noninferior to the EES with respect to the primary endpoint of cardiac death, target vessel MI, and ischemia-driven target lesion revascularization.

More than 2200 patients at 17 centres in Europe and Israel completed the 2-year follow-up. Patient-related events (all deaths,  MIs, and revascularizations) occurred equally in both groups (20.6% of the ZES group and 20·5% of the EES group). Similarly, stent-related events (target lesion failure) occurred in 11·2% of the ZES group and 10·7% of the EES group (p=0·736). Three patients in each group had a stent thrombosis after 1 year.

The investigators point out that “the greater number of patient-related than stent-related events in patients with complex clinical and lesion characteristics emphasises that during long-term follow-up, the optimisation of secondary prevention is at least as important as the selection of which new generation drug-eluting stent to implant in a specific lesion.”

In an accompanying comment, Jens Lassen writes that “the most important take-home message of the 2-years result of the RESOLUTE All Comers trial is that the overall non-inferiority result was preserved even after cessation of dual antiplatelet therapy, and that the low rate of very late stent thrombosis seems to be achieved without a major increase in late target lesion revascularisations.”

For more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup.

April 3rd, 2011

PARTNER B Substudy Examines Cost-Effectiveness of TAVI

Transcatheter aortic valve implantation (TAVI) is about as cost-effective as other common cardiovascular procedures, according to results of the PARTNER B cost-effectiveness substudy, which were presented today at the American College of Cardiology meeting in New Orleans. (The main results of PARTNER B, which studied the safety and efficacy of TAVI in patients with severe aortic stenosis who were not candidates for surgical treatment, were presented and published last year.)

Matthew Reynolds reported that the admission cost of TAVI,  including both hospital and physician fees, as well as an estimated $30,000 cost for the device, was $78,000. In the following 12 months, patients in the control group were twice as likely to be hospitalized than those in the TAVI group; the number of hospital days was 20 for control patients compared to 9 for TAVI patients. The followup costs at 1 year were $29,352 in the TAVI group compared to $52,724 in the control group.

The investigators projected the life expectancy of patients in TAVI as 3.11 years and the control group as 1.23 years. They then calculated the cost effectiveness of TAVI versus control as $50,000 per life year. However, when they calculated the quality-adjusted life years the incremental cost of TAVI was $79,837.

In his summary, Reynolds said that the “overall 1-year costs remained substantially higher with [TAVI].” Reynolds said that the cost-effectiveness of TAVI was better than dialysis and comparable to AF ablation and dabigatran.

He concluded: “For patients with severe aortic stenosis who are unsuitable for surgical valve replacement, [TAVI] significantly increases life expectancy at an incremental cost per life year gained that is well within accepted values for commonly used cardiovascular technologies.”

For more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup.

April 3rd, 2011

From Far in the Future to the Here and Now: Reflections on the Translational Research Symposium and a Session on VADs

Several Cardiology Fellows who are attending ACC.11 this week are blogging together on CardioExchange. The Fellows include Sandeep Mangalmurti, Hansie Mathelier, John Ryan (moderating and providing an outsider’s view from Chicago), Amit Shah, and Justin Vader. See the next post in this series, and check back often to learn about the biggest buzz in New Orleans.

This is my first ACC conference, so I’ll be playing the role of naïf in this blog series.

Saturday was a quiet day at the convention center compared to what I am sure the following days will offer, but it was an ideal way for me to get my feet wet. I went to a session on a topic I know very little about and probably won’t touch on my personal practice for another 20 years at best, and I went to another session offered by Mayo that touched on common questions that have arisen just recently.

The Translational Research Symposium’s early session offered a look at stem cell therapy’s recent successes and perspective on where the field might head. Most of the data presented were in mesenchymal stem cells, though a interesting concept presented by Dr Fernando Aviles involved liposuction in the cath lab, followed by a proprietary process of centrifugation of the fat and reinjection of stem cells. The data for the adiposed-derived stem cells appeared to be modest, but the idea of combining a cosmetic procedure with cell-based therapy is pretty slick. I know a few patients that could benefit from a dozen or so of these procedures. One word of caution should you go hunting for video on the internet – liposuction is really violent and if you have my kind of stomach you could find yourself quickly nauseated. More seriously in this field, the thought is that stem-cell therapies for treatment-refractory angina are closest to the point of being considered by the FDA and the functional data from the ACT-34 trial presented by Dr Henry look impressive, particularly compared side-by-side with the ranolazine data for this group of patients who we all struggle with managing.

Later I was thwarted in my attempt to see an update on acute heart failure pharmacotherapies – the room was overflowing. What could have possibly transpired in acute heart failure in the last year? Serendipitously I ran into some old residency classmates from Dallas as I made my way to the overflow room and together we found a satellite course from Mayo Clinic on VADs – an area I’m interested in. As a bonus, there was lunch! Mayo’s course offerings are always strong in my experience and I have to say I admire their industriousness in generating revenue via these courses almost as much as I do the content. Echo course in paradise? Congenital conference in wine country? Brilliant! Sign me up!

Today, Sunday, is another day as I sit here in the overflow room for the PARTNER presentation. The carnival of vendors is alive and rolling downstairs and the environment upstairs is more business-like. We’ll see if there’s lunch to be had.

For more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup.

April 3rd, 2011

PARTNER A: TAVI Noninferior to Surgery, but Stroke Might Be a Problem

Here are the main results of the much anticipated PARTNER A trial comparing transcatheter aortic valve implantation (TAVI) versus surgery for aortic valve replacement (AVR). They were presented this morning in New Orleans at the ACC.

Some 699 high-risk older patients with severe aortic stenosis were randomized to either TAVI or AVR.  The primary endpoint, all-cause mortality at 1 year, was 24.2% in the TAVI group and 26.8%  in the AVR group (HR 0.93, CI 0.71-1.22, p=0.62), thereby meeting the prespecified margin for noninferiority. Thirty-day mortality was 3.4% and 6.5%, respectively (p=0.07).

The rate of major stroke at 1 year was 5.1% for TAVI versus 2.4% for AVR (p=0.07). For all strokes, the difference achieved statistical significance: 8.3% versus 4.3% (p=0.04). There were no significant differences at either 30 days or 1 year in cardiac mortality, rehospitalization, MI, or acute renal injury requiring renal replacement therapy.

Major vascular complications occurred more frequently with TAVI, both at 30 days (11% versus 3.2%, p<0.01) and at 1 year (11.3% versus 3.5%, p<0.01). Major bleeding, on the other hand, occurred more often with AVR, both at 30 days (9.3% versus 19.5%, p<0.01) and at 1 year (14.7% versus 25.7%, p<0.01).

New AF occurred more frequently in the surgery group: 12.1% versus 17.1% at 1 year (p=0.07).

The rate of all-cause mortality or stroke was 26.5% for TAVI versus 28% for AVR (p=0.70).

The authors conclude: “Both [TAVI] and AVR were associated with important but different peri-procedural hazards: Major strokes at 30 days and one year and major vascular complications were more frequent with [TAVI.] Major bleeding and new onset atrial fibrillation were more frequent with AVR. [TAVI] and AVR are both acceptable therapies in these high-risk patients; differing peri-procedural hazards may impact case-based decision-making.”

View Rick Lange’s Interventional Cardiology blog on the PARTNER A trial here, and for more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup.

April 3rd, 2011

TAVI: PARTNER or Blind Date?

Almost 700 patients with severe aortic stenosis who were considered “high risk” for conventional valve replacement (AVR) were randomized to transcatheter aortic valve implantation (TAVI) or AVR.

In comparison to AVR, TAVI was associated with a higher incidence of stroke (5.1% vs 2.4% at one year), vascular complications (11.0% vs 3.2% at 30 days), and moderate-severe perivalvular leak (6.8% vs 1.9% at one year), with no mortality (24.2% vs. 26.8% at one year) or clinical benefit. 

Yet the lead investigator touts TAVI as an “excellent alternative” to AVR because it was associated with less atrial fibrillation (8.6% vs 16%) and bleeding (9.3% vs 19.5%).

This is an interesting conclusion, since most physicians and patients are more concerned about periprocedural stroke and vascular complications than atrial fibrillation or transfusions.

In “high-risk” patients eligible for AVR, is TAVI really a PARTNER or a blind date (“Thanks, but no thanks”)? 

Will you offer TAVI to your “high-risk” aortic stenosis patients as an “excellent alternative” to AVR?

View our news coverage of the PARTNER A trial here, and for more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup.

April 1st, 2011

Who’s Paying for the Fellows?

Several Cardiology Fellows who are attending ACC.11 this week are blogging together on CardioExchange. The Fellows include Sandeep Mangalmurti, Hansie Mathelier, John Ryan (moderating and providing an outsider’s view from Chicago), Amit Shah, and Justin Vader. See the next post in this series, and check back often to learn about the biggest buzz in New Orleans.

By this stage, those traveling to New Orleans for ACC/i2 have their flights booked and accommodation arranged.

With so many different conferences going on each year, how do fellows decide which ones to attend? Do people prefer the big meetings like ACC and AHA, or would they rather attend the subspecialty conferences such as those offered by ASE, HFSA, and SCAI ? Or is it simply a matter of where their abstracts get accepted?

Most fellowship programs seem to guarantee their fellows the chance to attend at least one meeting per year. But this brings us to the most important question. As many an Irish mother would say, “These meetings are all well and good, but who is paying for all of this?” How do fellows fund the trips to these conferences? At my institution, each fellow is provided an educational allowance for the year — this can cover anything from travel and accommodation for attending conferences to tuition for courses or the cost of textbooks. At the end of the year, we each submit our receipts and get reimbursed up to a certain amount.

I know of some fellows who, when presenting research, are covered by their research group for conference costs. Perhaps someone with experience in this area can elaborate on these types of opportunities?

Other options include paying out of pocket, being supported by industry, or obtaining a travel grant. Do many fellows pursue these alternatives? How hard or easy is it for most fellows to get financial support to attend conferences?

For more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup.

March 31st, 2011

A Delectable Side Benefit of ACC — New Orleans Restaurants

Obviously, the emphasis at ACC is on science and research. However, we all know that these meetings provide unique opportunities for reunions and social events for traveling cardiologists. For me, one of the highlights of any meeting is when my faculty arranges a dinner or when I can get away with others from the stressors of clinics and inpatient services to socialize and eat good food.

Creating a “best of” list of New Orleans’ restaurants is like picking your favorite TIMI study — there are just too many to choose from. But here is my effort. Do you have any suggestions or comments about these or other great restaurants in New Orleans? Let other ACC-bound fellows know by commenting below.

See the previous Fellowship Training blog on 2011 ACC: A Meeting That Could Change How You Practice

Commander’s Palace
Call now if you do not have a reservation yet; unbelievable food — the best meal you will ever eat
1403 Washington Ave. (at the corner of Coliseum Street in the Garden District)
504-899-8221

The Bombay Club Restaurant & Martini Bistro
Live music and good food
830 Conti St.
504-586-0972

Alex Patout Louisiana Restaurant
Great seafood
720 St. Louis St.
504-525-7788

Casamento’s Restaurant
Italian
4330 Magazine St.
504-895-9761

Iris
American cuisine
321 N. Peters St.
504-299-3944

Emeril’s Restaurant
The flagship
800 Tchoupitoulas St.
(504) 528-9393

Restaurant August
Chef John Besh’s restaurant; fusion of French and American food
301 Tchoupitoulas St.
504-299-9777

Creole Creamery
Ice cream
4924 Prytania St.
504-864-8680

Surrey’s Cafe & Juice Bar
Great place for breakfast
1418 Magazine St.
504-524-3828

The Joint
BBQ
801 Poland Ave.
504-949-3232

Willie Mae’s Scotch House
Best fried chicken you will ever eat
2401 St Ann St.
504-822-9503

Broussard’s Restaurant
Great courtyard; classic cuisine
819 Rue Conti
504-581-3866

Arnaud’s Restaurant
Creole
813 Bienville St.
504-523-5433

Brennan’s Restaurant
French and Creole; great breakfast
417 Royal St.
504-525-9711

GW Fins
Seafood
808 Bienville St.
504-581-3467

Galvez Restaurant
Spanish food, including tapas, on the Riverfront
914 North Peters St.
(504) 595-3400

For more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup.