Disclosures: The study and editorial authors report no relevant financial disclosures.
October 04, 2021
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Permanent pacemaker implantation may not affect outcomes after TAVR

Disclosures: The study and editorial authors report no relevant financial disclosures.
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Among patients who had transcatheter aortic valve replacement, there was no difference in survival or adverse CV outcomes between those who required a pacemaker and those who did not, researchers reported.

TAVR has rapidly evolved during the last decade. TAVR and surgical AVR are the only treatment options for patients with severe aortic valve stenosis. However, the prevalence of permanent pacemaker implantation after TAVR ranges from 9% to 26%,” Andreas Rück, MD, PhD, of the department of cardiology at Karolinska University Hospital in Stockholm, and colleagues wrote. “As the use of TAVR expands to include younger and low-risk patients with a long life expectancy, it will become increasingly important to understand the impact of permanent pacemaker implantation after TAVR. Therefore, we performed an observational, nationwide, population-based cohort study to investigate clinically important outcomes in patients who underwent permanent pacemaker implantation after TAVR.”

Pacemaker
Source: Adobe Stock

This analysis included all patients in the SWEDEHEART registry who underwent transfemoral TAVR in Sweden from 2008 to 2018. Researchers acquired baseline characteristics and outcomes data via individual crosslinking with other national health data registries.

Pacemaker implantation and outcomes after TAVR

Of 3,420 patients who underwent TAVR (mean age, 81 years; 50% women), 14.1% received permanent pacemaker implantation within 30 days.

According to the study, patients who received a permanent pacemaker were less likely to be women; had a higher prevalence of atrial fibrillation, diabetes, prior MI and prior cardiac surgery; and had a lower prevalence of balloon-expandable valves.

The rate of survival at 1 year (pacemaker, 90%; no pacemaker, 92.7%), 5 years (pacemaker, 52.7%; no pacemaker, 53.8%) and 10 years (pacemaker, 10.9%; no pacemaker, 15.3%) was not significantly different between patients who underwent pacemaker implantation after TAVR compared with those who did not (HR = 1.03; 95% CI, 0.88-1.22; P = .692).

The researchers also observed no between-group differences in risk for CV death (HR = 0.91, 95% C, 0.71-1.18; P = .611), HF (HR = 1.23, 95% CI, 0.92-1.63; P = .157) or endocarditis (HR = 0.9; 95% CI, 0.47-1.69; P = .734).

“In contrast to most previous studies, we only included patients who underwent transfemoral TAVR to ensure a more homogenous patient cohort,” the researchers wrote. “We followed our patient cohort for up to 11.8 years after TAVR and found no difference in mortality or heart failure between the groups; however, even longer follow-up might be needed for clinically overt heart failure and increased mortality to become apparent.

“As the use of TAVR expands, the higher risk of requiring permanent pacemaker implantation after TAVR than after surgical AVR remains a concern,” the researchers wrote. “It is, thus, important to find strategies to reduce the rate of pacemaker implantation after TAVR.”

‘We must be cautious’

In a related editorial, Antonio J. Muñoz-García, MD, PhD, and Erika Muñoz-García, MD, of the cardiology department at the University Hospital Virgen de la Victoria, Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares in Málaga, Spain, discussed the need for caution when interpreting these results.

“Overall, this study provides reassuring outcomes (‘a light that does not overshadow the forecast’); however, we must be cautious when extrapolating these results to the rest of the TAVR population, as it is still poorly understood,” the editorial authors wrote.

“To date, the impact of permanent pacemaker implantation on late clinical outcomes after TAVR remains controversial; however, this study to some extent helps clarify this controversy. But to solve this lack of consensus, it is necessary to reduce the rate of permanent pacemaker implantation, homogenize criteria and studies and have long-term clinical follow-up,” the editorial authors wrote.

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