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Post-TAVR Pacemakers Not All Doom and Gloom

— A bit of reassurance from Swedish cohort study

MedpageToday
An x-ray image showing an implanted pacemaker highlighted in yellow.

People who needed permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR) did not live shorter lives after the procedure, according to records from the SWEDEHEART registry.

In a nationwide cohort study from Sweden, mortality rates reached 44.1% and 34.7%, respectively, over a median 2.7 years among pacemakers recipients and those who didn't need them after transfemoral TAVR, which was not a significant difference (HR 1.03, 95% CI 0.88-1.22).

Survival up to a decade was statistically similar between pacemaker and no pacemaker groups in the 3,420-person study. Those groups, respectively, had:

  • 1-year survival of 90.0% vs 92.7%
  • 5-year survival of 52.7% vs 53.8%
  • 10-year survival of 10.9% vs 15.3%

Both groups also shared similar risks of cardiovascular death, heart failure, and endocarditis, reported Natalie Glaser, MD, PhD, of Stockholm South General Hospital, and colleagues online in .

"Although we did not find an increased mortality rate or risk of heart failure in patients who underwent PPM implantation after TAVR, PPM implantation is associated with a risk of lead- and pocket-related complications and traumatic complications, longer hospital stays, and higher societal costs," the investigators noted.

This is especially important for the younger and low-risk patients with aortic stenosis who are now eligible for TAVR but have longer life expectancies and therefore more time to develop TAVR complications.

"As the use of TAVR expands, the higher risk of requiring PPM implantation after TAVR than after SAVR [surgical aortic valve replacement] remains a concern. It is thus important to find strategies to reduce the rate of pacemaker implantation after TAVR," the researchers concluded.

The observational study comprised SWEDEHEART participants who underwent transfemoral TAVR at one of eight participating centers in Sweden in 2008-2018. Patients included in the analysis had to have survived the first 30 days after discharge and were excluded if they received a valve-in-valve procedure.

Those 3,420 individuals averaged 81 years of age and were fairly evenly split between the sexes.

Glaser and colleagues reported that PPM placement had occurred within 30 days following TAVR in 14.1% of cases. "Although newer-generation aortic valve prostheses have a lower risk of necessitating PPM implantation, the need for PPM implantation remains the most frequent complication after TAVR," they noted.

PPM recipients tended to be men with a relatively high prevalence of atrial fibrillation, diabetes, prior myocardial infarction, and prior cardiac surgery. This group was less likely to have received a balloon-expandable valve during TAVR.

The Swedish registries were unable to provide valuable clinical data such as preprocedural conduction disturbances, indications for PPM implants, pacing dependency, and left ventricular ejection fraction during follow-up.

Furthermore, the observational study was limited by the potential of residual confounding, according to the authors.

Nevertheless, the report seemed to provide some reassurance amid the conflicting literature regarding PPM placement's clinical impact in TAVR, two clinicians said in an .

"To date, studies evaluating the effects of PPI [PPM implantation] post-TAVR on clinical outcomes have produced controversial results and had limited follow-up periods," wrote Antonio Muñoz-García, MD, PhD, and Erika Muñoz-García, MD, both of University Hospital Virgen de la Victoria in Málaga, Spain.

To minimize confounding in future studies, the editorialists urged a unification of criteria, indications, and time of PPM implantations.

Indeed, an has been published for the management of conduction disturbances after TAVR.

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    Nicole Lou is a reporter for 51˶, where she covers cardiology news and other developments in medicine.

Disclosures

This work was supported by the Swedish Heart-Lung Foundation, the Swedish Society of Medicine, Region Stockholm, a regional agreement between Stockholm County Council and Karolinska Institutet, the Capio Research Foundation, the Eva and Oscar Ahrén Research Foundation, and the Seraphim Hospital Foundation.

Glaser and the editorialists had no disclosures.

Primary Source

JACC: Cardiovascular Interventions

Rück A, et al "Outcomes following permanent pacemaker implantation after transcatheter aortic valve replacement: SWEDEHEART observational study" JACC Cardiovasc Interv 2021; DOI: 10.1016/j.jcin.2021.07.043.

Secondary Source

JACC: Cardiovascular Interventions

Muñoz-García AJ, Muñoz-García E "Pacemaker implantation after transcatheter aortic valve replacement: controversial complications with prognostic uncertainties -- clearing the unknowns" JACC Cardiovasc Interv 2021; DOI: 10.1016/j.jcin.2021.08.061.