HOUSTON – About 1 in 10 Medicare patients require implantation of a permanent pacemaker following transcatheter aortic valve replacement, results from a large analysis showed.
“There is conflicting evidence and some debate over permanent pacemaker placement following transcatheter aortic valve replacement – whether it has a protective or adverse effect, and how often it takes place,” study investigator Fenton H. McCarthy, MD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.
One recent study found that permanent pacemaker placement within 30 days post TAVR was found in 6.7% of patients undergoing balloon-expanding or self-expanding valve implantation, and is associated with increased mortality and hospitalizations (JACC Cardiovasc Interv. 2016 Nov 14;9[21]:2189-2199).
To evaluate the relationship between permanent pacemaker implantation and long-term patient outcomes among Medicare beneficiaries undergoing TAVR, Dr. McCarthy, a cardiothoracic surgery fellow at the University of Pennsylvania, Philadelphia, and his associates used Medicare carrier claims and Medicare Provider Analysis and Review files to identify 14,305 TAVR patients between January 2011 and December 2013.
Dr. Fenton McCarthy
The researchers used univariate Kaplan survival estimates and multivariable models to analyze survival, readmission and risk factors for pacemaker implantation.
The mean age of the 14,305 TAVR patients studied was 83 years, and 11% received a permanent pacemaker after TAVR. Of these, 9% received the pacemaker at index hospitalization, 1% at 30 days after implant, 0.5% at 90 days after implant, and 1% at 1 year after implant. Patient age of greater than 90 years was a significant predictor of pacemaker placement, with an odds ratio of 1.7 (P less than .01).
Dr. McCarthy and his associates observed that the readmission rates for pacemaker placement and no pacemaker placement at index hospitalization were similar at 30 days (21% vs. 19%, respectively), at 90 days (33% vs. 31%) and at 1 year (43% in both groups of patients).
In addition, Kaplan Meier estimates revealed no significant difference in long-term survival for patients with pacemaker placement within 30 days of TAVR, while multivariate Cox proportional hazard modeling revealed that pacemaker placement is not a predictor of long-term mortality (hazard ratio, 1.03; P = .65).
“This was the largest study to evaluate the question of incidence and effect of permanent pacemaker in the transcatheter aortic valve replacement population in the United States,” Dr. McCarthy said. “The size of our data set and the fact that the Medicare database includes all types of patients, regardless of trial participation, study or registry, is a strength of this study. Some other studies have used different inclusion and exclusion criteria. We used broad inclusion criteria and evaluated patients from as many different centers as possible.”
A key limitation of the study, he said, was that the researchers were unable to determine whether a patient received a balloon-expanding or self-expanding TAVR.
Dr. McCarthy reported having no financial disclosures.