The American College of Cardiology (ACC) held its annual conference March 14-16 in San Diego. Here are some highlights and perspectives on the sessions.

Turning TAVR’s growth into hospital profits

Transcatheter aortic valve replacement (TAVR) programs are picking up steam in the U.S. And they can be fiscal as well as clinical successes, but it requires physicians and administrators working together to maximize efficiencies.

The U.S. and Europe account for 89 percent of TAVR cases worldwide, says Michael Mack, MD, of the Heart Hospital Baylor Plano in Texas. In 2013, the U.S. had 350 TAVR centers—more than half the total worldwide.

But are those centers a good business proposition? G. Michael Deeb, MD, director of the Multidisciplinary Aortic Clinic at the University of Michigan Health System in Ann Arbor, says hospitals need to weigh the upfront investment against the downstream benefit with an eye on the bottom line. The capital investment can be high, with multimillion-dollar hybrid operating setups and valves costing about $30,000.

His center saw a 17 percent increase in surgical aortic valve replacement (SAVR) procedures after the first full year of the TAVR program but that trajectory dwindled over time as patient volume shifted from SAVR to TAVR. “What you really want to do is make direct, not indirect, profits,” Deeb says. “How are you going to do this?”

Their solution involved an emphasis on efficiencies. For instance, make sure the hybrid room is in use, if not with TAVR, then with other hybrid procedures, and develop a flex team with multitasking cath and OR personnel. They analyzed the entire procedure to identify inefficiencies and determine how to stagger cases. As a result, they improved caseload from two procedures a day to five, with physicians done by 5 p.m. 

The hospital will look at direct margins per inpatient day to determine if TAVR is worth the investment. In their case, they reported an increase for TAVR of about $300 between 2011 and 2014. SAVR also rose about $500. 

Focusing big data on patients fosters better preventive care

“Big data” can change healthcare into a system that better focuses on early detection and prevention rather than acute care—if physicians make better use of it.

“Data is one of the big trends in health information technology,” says James Tcheng, MD, of the Duke Clinical Research Institute in Durham, N.C. “But I would suggest that we’re really falling short of meaningful use of health information technology. We’re focusing on the wrong place.”

Physicians use it as an administrative tool rather than figuring out how to apply the data that flows through their systems to better care for individual patients, he says. “Big data is squishy. It really is hard to put your hands around, but leveraging the appropriate data streams has the potential to change the paradigm of healthcare, by taking big data and focusing it down on the patient.”

Physicians need to take general information and apply it to individual patients to shift the healthcare paradigm, says Jeroen Tas, CEO of Philips Healthcare. In a country that spends $3 trillion on healthcare, 83 percent goes to chronic disease. Yet the system is organized around acute care. The information provided by big data can change that, allowing healthcare to be organized around a health continuum and the needs of each patient.

“I think if we do this, we cannot just marginally improve healthcare, we can truly exponentially improve healthcare,” Tas says.

Upcoming PCI AUC take into account past criticisms 

Acknowledging there was room for improvement, the authors of PCI appropriate use criteria (AUC) have applied lessons from the last set of guidelines in a revision scheduled for publication this year, attendees learned at one session.

Writing committee member Gregory J. Dehmer, MD, of Scott & White Healthcare in Temple, Texas, says the AUC are a work in progress. “We are still learning how to apply them.”

The AUC were developed proactively by cardiologists to reduce variation and improve the quality of care. Publication of the AUC led to some unintended consequences, though. Specifications that the criteria should not be tied to reimbursement fell on deaf ears, and the misinterpretation of uncertain procedures and lumping them with inappropriate PCIs created a skewed public perception of overuse.

“You need to understand that uncertain means there was not enough clinical information available to make a firm determination or, even more importantly, there is not enough clinical, scientific experimental data out there to say clearly which therapy is superior to the other,” he says. “That is what uncertain means. It does not mean you have done something wrong.”

The wording that will be used in the 2015 guidelines is appropriate, may be appropriate and rarely appropriate. The new language allows for the possibility that a treatment that is rarely appropriate is nonetheless the best option for an individual patient. But if that is the case, the interventional cardiologist should carefully document the encounter.

The new version will take into account issues identified in the 2012 AUC, Dehmer promises. “There are many criticisms that the writing group has tried to address in the new AUC.”

PARTNER I outcomes equal for TAVR, surgery at 5 years

High-risk patients with severe aortic stenosis had similar outcomes at five years in both arms of the PARTNER I trial.

PARTNER I randomized 699 patients to either treatment with Edwards Lifesciences’ Sapien transcatheter aortic valve replacement (TAVR) device or surgery. At five years, the all-cause mortality rate was 67.8 percent in the TAVR group and 62.4 percent in the surgery group and cardiovascular mortality was 53.1 percent vs. 47.6 percent. The stroke rate totaled 15.9 percent with TAVR and 14.7 percent with surgery. Repeat hospitalization rates and functional outcomes were similar was well.

Since the inception of PARTNER I, the technology has been revised, 3D imaging protocols introduced, heart teams have gained experience and programs have gotten wiser about selecting appropriate patients. “The fact that this is a tie means TAVR wins,” says principal investigator Michael Mack, MD, of Baylor Scott and White Health in Dallas.

CoreValve’s advantage over surgery widens at 2 years

So it wasn’t a fluke. Two-year results from the CoreValve pivotal trial for high-risk patients with severe aortic stenosis reaffirmed that the transcatheter aortic valve replacement (TAVR) device is superior to standard surgery.

At one year, the trial met noninferiority and superiority endpoints for all-cause mortality. But some physicians questioned whether slight differences in deaths would challenge the margin that favored TAVR. At one year, the all-cause mortality rate for the TAVR group was 14.2 percent vs. 19.1 percent for the surgical group. By two years, the spread widened, at 22.2 percent vs. 28.6 percent. By year two, stroke and all-cause mortality together reached a difference of 8.6 percent.

“Our survival advantage that we saw at one year is both durable and sustainable, and in fact it is actually widening over time,” says Michael J. Reardon, MD, of Houston Methodist Hospital. If that trend continues, it may provide a challenge to competing therapies.

“It sets the bar and it sets the bar high,” Reardon proposes.

TOTAL raises flag with use of routine thrombectomy

TOTAL may not totally spell the end of routine manual thrombectomy with PCI, but it should make interventional cardiologists think twice about using it with STEMI patients. The large, international trial showed no clinical benefit and possible harm.

Between 2010 and 2014, TOTAL (The Trial of Routine Aspiration Thrombectomy with PCI versus PCI Alone in Patients with STEMI) researchers randomized 10,732 patients with STEMI to routine thrombectomy or PCI alone. The protocol allowed bailout thrombectomy in the PCI alone group. The primary outcome was death from cardiovascular causes, recurrent MI, cardiogenic shock or New York Heart Association class IV heart failure at 180 days. For safety, they assessed stroke at 180 days.

The rate of the primary outcome was similar for both groups. Stroke was more common in the thrombectomy group, though. At 30 days, the rate of stroke with thrombectomy was 0.7 percent vs. 0.3 percent with PCI alone. Those rates increased to 1 percent and 0.5 percent, respectively, at 180 days.

A total of 7 percent of patients in the PCI alone group required thrombectomy bailout. “That is an important take-home message,” says lead researcher Sanjit Jolly, MD, of McMaster University in Hamilton, Ontario.

Jolly says that an ACC National Cardiovascular Data Registry analysis showed about 20 percent of physicians use routine thrombectomy and, based on a survey by his research group, about 30 percent internationally. Panelist David Kandzari, MD, of the Piedmont Heart Institute in Atlanta, predicts “that number would decline moderately after these results. But considering bailout use, we would continue to see some use of thrombectomy."

PCSK9 inhibitor appears to improve outcomes 

The human monoclonal antibody evolocumab plus standard therapy not only lowered low-density lipoprotein (LDL) cholesterol but it also cut the rate of cardiovascular events by about half compared with standard therapy alone.

Evolocumab (Amgen) is a new class of drugs that inhibits proprotein convertase subtilisin-kexin 9 (PCSK9). The phase 2 OSLER-1 (Open-Label Study of Long-term Evaluation against LDL Cholesatrol-1) and phase 3 OSLER-2 trials evaluated the drug’s safety and effectiveness at lowering LDL cholesterol. Marc Sabatine, MD, of Brigham and Women’s Hospital in Boston, shared findings on cardiovascular outcomes.

Patients who completed the trials had the option to enroll in extension studies. About three-quarters of them chose to participate, with 2,976 randomized to receive evolocumab plus standard therapy and 1,489 to standard therapy alone. They were followed for a median 11.1 months.

At week 12, LDL cholesterol was lowered by 61 percent in the evolocumab group compared with standard therapy alone. At one year, cardiovascular events were lower in the evolocumab group, too, at 0.95 percent vs. 2.18 percent. “Evolocumab decreased cardiovascular outcomes by 51 percent at one year,” he says. “We need to acknowledge that there were few events. However, the event curves diverged early over time.”

The treatment appeared to be safe and well tolerated, but the rate of neurocognitive adverse events—while rare—was higher in the evolocumab group, which should be further studied, Sabatine says.