Use of new-generation transcatheter heart valve (THV) systems is associated with significantly lower incidence of permanent pacemaker implantation (PPI) compared to older generations of valve, new data from the multicenter VIVID Registry shows.
While the study – published online Monday and in the May 11 issue of the Journal of the American College of Cardiology – shows reduced incidence of PPI from the use of new-generation THVs versus older-generation valves, it also suggests that PPI after valve-in-valve (ViV)-transcatheter aortic valve replacement (TAVR) is associated with poorer clinical outcomes, including increased mortality, after average follow-up of 13 months.
TAVR is a widely accepted alternative to surgical aortic valve replacement for treating elderly patients with symptomatic severe aortic stenosis, said the team behind the study, led by first author Alberto Alperi at the Quebec Heart and Lung Institute. However, they noted that the occurrence of conduction disturbances, and particularly the need for PPI, “remains one of the most important shortcomings of TAVR procedures.”
As such, the new study set out to determine the incidence, factors associated with, and clinical impact of, PPI in a large series of ViV-TAVR procedures using data from the multicenter Valve-in-Valve International Data (VIVID) Registry – an international collaboration including more than 180 centers from the Americas, Europe, Middle East, Asia, Africa and Oceania.
In this contemporary and large registry of ViV-TAVR patients, the team found the rate of periprocedural PPI was relatively low, “and its incidence decreased with the use of new-generation THV systems.”
A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included in the analysis, with a total of 128 patients (6.4%) seen to have PPI during hospitalization following TAVR.
Patients who had a PPI after TAVR were older (p < 0.001), had more peripheral vascular disease (p = 0.017), had more frequently received an early generation (p = 0.017) and larger (p = 0.03) THV, and exhibited a higher rate of THV malpositioning (p = 0.052).
A significant decrease in the rate of PPI was seen with the use of new- versus early generation THVs (4.7% vs. 7.4%; p = 0.017), said the authors. This decrease was related to a significant reduction in PPI rate in self-expanding Evolut R/Pro recipients versus their CoreValve counterparts (3.7% vs. 9.0%; p = 0.002). Similar rates of PPI after TAVR were seen between balloon-expandable Sapien 3 and Sapien/Sapien XT patients (6.1% and 5.2%, respectively; p = 0.61).
“The use of new generation valve systems was associated with a lower incidence of PPI (<5%), and this was mainly related to a major reduction of PPI with the newer generation CoreValve Evolut THV system,” the authors said, reiterating more than a 50% decrease in incidence of PPI between older-generation CoreValve and new-generation Evolut systems (9% CoreValve vs 3.7% Evolut R/Pro).
However, they noted that there were no differences between new-generation valve types regarding the incidence of PPI after ViV-TAVR.
While newer-generation valves had a significant impact on PPI incidence, there were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18), the researchers added.
There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients showed a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p =0.04; p = 0.08 after adjusting for age differences between groups).
Better PPI prediction needed?
An accompanying editorial penned by Colin M. Barker, MD, of the Vanderbilt University Medical Center and Vascular Institute, notes that the findings presented by Alperi et al. from the VIVID registry “are encouraging considering the low pacemaker rate.”
However, he suggested caution is warranted regarding the increased mortality rate in those who did require pacemakers.
Baker warned that while reductions in PPI use due to innovations in device design and procedural technique are a good thing, better tools to predict who will categorically end up needing a PPI are still needed – especially given the higher mortality rates.
“Eliminating the risk that a pacemaker will be required after TAVR would be ideal but is unrealistic,” he noted, adding that refining prediction models beyond age, underlying conduction disorder, and procedural technique will be vital in the future.
“If we had a way to predict a >95% likelihood of needing a PPI after TAVR, we could engage our electrophysiology colleagues early, and patients could be implanted with optimal devices. This would be in the spirit of the best care for patients and not just in an effort to minimize or eliminate a perceived complication,” he said, adding that a more challenging unmet need will be developing higher resolution and higher precision techniques to define those who ultimately would benefit from PPIs.
Multiple authors of the study have received institutional research grants from industry including Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific. Colin Barker, MD, author of the editorial is an advisory board member for Medtronic and Boston Scientific; and has received research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular. Edwards Lifesciences makes the Sapien valves, and Medtronic manufactures the CoreValve and Evolut valves.
Alperi A, Rodés-Cabau J, Simonato M, et al. Permanent Pacemaker Implantation Following Valve-in-Valve Transcatheter Aortic Valve Replacement: VIVID Registry. J Am Coll Cardiol 2021;77: 2263-73
Barker CM. Permanent Pacemaker Implantation After TAVR for Degenerated Bioprosthetic Surgical Valves: We Could Do Better. J Am Coll Cardiol 2021;77: 2274-5