Long-Term Outcomes, Cost May Influence Use of TAVR in Moderate-Risk Patients

San Francisco, CA—The use of transcatheter aortic valve replacement (TAVR) for patients with moderate-risk aortic stenosis is common and appears justified based on short-term evidence, but questions remain about long-term outcomes and the costs associated with the procedure, according to a debate at TCT 2013.

Concerns addressed

Several studies established TAVR as equivalent to surgical AVR in terms of mortality, according to Stephan Windecker, MD, of Swiss Cardiovascular Center Bern, Switzerland.

A three-center study by Piazza and colleagues evaluated 510 patients with severe aortic stenosis at intermediate surgical risk. Half of the patients underwent TAVR and half underwent surgery. 

The results, published in the Journal of American College of Cardiology: Cardiovascular Interventions, showed that the Society of Thoracic Surgeons risk score of TAVR patients decreased over time and this was associated with no significant change in mortality.

Another study by Wenaweser and colleagues evaluated TAVR in 389 patients, 295 of whom were considered low or intermediate risk. The results, published in the European Heart Journal, showed RR for CV death at 1 year was 0.16 (95% CI 0.04-0.70) for low-risk patients compared with high-risk patients. The RR was 0.35 (95% CI 0.19-0.62; P<.001) for intermediate-risk patients compared with those at high risk.

At 30 days, researchers reported no CV death, major stroke or major vascular complications among low-risk patients who underwent transfemoral TAVR.

“Lower-risk and intermediate-risk patients do what you expect them to do: They perform better,” Windecker said. Many of the concerns surgeons cite in opposition to TAVR in low- or intermediate-risk patients have been alleviated, Windecker said.

Improved delivery — including steerable delivery catheters, no-touch techniques and low-profile catheters — as well as advances in antithrombotic therapy have reduced the risk of cerebrovascular accidents, Windecker added. 

TAVR devices are selected for specific patients based on anatomical characteristics, reducing risk for paravalvular aortic regurgitation.

Results of cohort A of the PARTNER trial show no difference in performance between surgical and percutaneous valves at 3 years.

“I think the issue of durability has been addressed,” Windecker said.

Ethical, moral questions

Lars G. Svensson, MD, PhD, of the Cleveland Clinic Foundation, countered that surgery clearly is the gold standard for patients with moderate-risk aortic
stenosis.

At Cleveland Clinic, from 2002 through July 2012, the mortality rate was 0.22% for moderate-risk patients aged younger than 70 years who underwent surgical AVR. The rate for those who underwent mini-AVR was 0.5%. The mortality rate for isolated AVR for all comers was 0.4% in 2012.

Long-term outcomes are critical, Svensson said. A review of 13,258 patients with AVRs show about two-thirds of elderly patients are alive 5 years after surgery.

In addition, PARTNER cohort A data indicated that the incidence of stroke and transient ischemic attack was more than three times higher (4.6% vs. 1.4%; P=.05) with transfemoral vs. surgical AVR. Also, 9.5% of patients experienced procedural failure, and moderate-to-severe aortic regurgitation at 6 months was 10.5%.

“By VARC definitions, 20% of patients did not get a successful procedure,” Svensson said. “If that was my operating record, I would not be working. Clearly we can make it better.”

Cost also will be a challenge, Svensson said.

At present the Centers for Medicare & Medicaid Services (CMS) does not pay for TAVR in high-surgical risk patients who are candidates for surgery.

“The buck stops — in the United States, at least — with CMS,” Svensson said. “We lose between $4,000 and $14,000 per case. Long term, that is [the question] society in general and the government has to answer: What do they have to pay for?”

Disclosures:

Svensson reports no relevant conflicts of interest.

Windecker reports receiving grant/research support from Abbott Vascular, BioSensors, Biotronik, Boston Scientific, Cordis, Medtronic CardioVascular and St. Jude Medical.