Clinical effects of permanent pacemaker implantation after transcatheter aortic valve implantation: Insights from the nationwide FRANCE-TAVI registry

International audienceBackgroundThe influence of permanent pacemaker implantation upon outcomes after transcatheter aortic valve implantation (TAVI) remains controversial.AimsTo evaluate the impact of permanent pacemaker implantation after TAVI on short- and long-term mortality, and on the risk of hospitalization for heart failure.MethodsData from the large FRANCE-TAVI registry, linked to the French national health single-payer claims database, were analysed to compare 30-day and long-term mortality rates and hospitalization for heart failure rates among patients with versus without permanent pacemaker implantation after TAVI. Multivariable regressions were performed to adjust for confounders.ResultsA total of 36,549 patients (mean age 82.6 years; 51.6% female) who underwent TAVI from 2013 to 2019 were included in the present analysis. Among them, 6999 (19.1%) received permanent pacemaker implantation during the index hospitalization, whereas 232 (0.6%) underwent permanent pacemaker implantation between hospital discharge and 30 days after TAVI, at a median of 11 (interquartile range: 7–18) days. In-hospital permanent pacemaker implantation was not associated with an increased risk of death between discharge and 30 days (adjusted odds ratio: 0.91, 95% confidence interval: 0.64–1.29). At 5 years, the incidence of all-cause death was higher among patients with versus without permanent pacemaker implantation within 30 days of the procedure (adjusted hazard ratio: 1.13, 95% confidence interval: 1.07–1.19). Permanent pacemaker implantation within 30 days of TAVI was also associated with a higher 5-year rate of hospitalization for heart failure (adjusted subhazard ratio: 1.17, 95% confidence interval: 1.11–1.23).ConclusionsPermanent pacemaker implantation after TAVI is associated with an increased risk of long-term hospitalization for heart failure and all-cause mortality. Further research to mitigate the risk of postprocedural permanent pacemaker implantation is needed as TAVI indications expand to lower-risk patients

Long-Term Prognosis Value of Paravalvular Leak and Patient–Prosthesis Mismatch following Transcatheter Aortic Valve Implantation: Insight from the France-TAVI Registry

International audienceBackground: Transcatheter aortic valve implantation (TAVI) is the preferred treatment for symptomatic severe aortic stenosis (AS) in a majority of patients across all surgical risks. Patients and methods: Paravalvular leak (PVL) and patient–prosthesis mismatch (PPM) are two frequent complications of TAVI. Therefore, based on the large France-TAVI registry, we planned to report the incidence of both complications following TAVI, evaluate their respective risk factors, and study their respective impacts on long-term clinical outcomes, including mortality. Results: We identified 47,494 patients in the database who underwent a TAVI in France between 1 January 2010 and 31 December 2019. Within this population, 17,742 patients had information regarding PPM status (5138 with moderate-to-severe PPM, 29.0%) and 20,878 had information regarding PVL (4056 with PVL ≥ 2, 19.4%). After adjustment, the risk factors for PVL ≥ 2 were a lower body mass index (BMI), a high baseline mean aortic gradient, a higher body surface area, a lower ejection fraction, a smaller diameter of TAVI, and a self-expandable TAVI device, while for moderate-to-severe PPM we identified a younger age, a lower BMI, a larger body surface area, a low aortic annulus area, a low ejection fraction, and a smaller diameter TAVI device (OR 0.85; 95% CI, 0.83–0.86) as predictors. At 6.5 years, PVL ≥ 2 was an independent predictor of mortality and was associated with higher mortality risk. PPM was not associated with increased risk of mortality. Conclusions: Our analysis from the France-TAVI registry showed that both moderate-to-severe PPM and PVL ≥ 2 continue to be frequently observed after the TAVI procedure. Different risk factors, mostly related to the patient’s anatomy and TAVI device selection, for both complications have been identified. Only PVL ≥ 2 was associated with higher mortality during follow-up

Outcomes of transcatheter aortic valve implantation for native aortic valve regurgitation

International audienceBackground: Large datasets of transcatheter aortic valve implantation (TAVI) for pure aortic valve regurgitation (PAVR) are scarce.Aims: We aimed to report procedural safety and long-term clinical events (CE) in a contemporary cohort of PAVR patients treated with new-generation devices (NGD).Methods: Patients with grade III/IV PAVR enrolled in the FRANCE-TAVI Registry were selected. The primary safety endpoint was technical success (TS) according to Valve Academic Research Consortium 3 criteria. The co-primary endpoint was defined as a composite of mortality, heart failure hospitalisation and valve reintervention at last follow-up.Results: From 2015 to 2021, 227 individuals (64.3% males, median age 81.0 [interquartile range {IQR} 73.5-85.0] years, with EuroSCORE II 6.0% [IQR 4.0-10.9]) from 41 centres underwent TAVI with NGD, using either self-expanding (55.1%) or balloon-expandable valves (44.9%; p=0.50). TS was 85.5%, with a non-significant trend towards increased TS in high-volume activity centres. A second valve implantation (SVI) was needed in 8.8% of patients, independent of valve type (p=0.82). Device size was ≥29 mm in 73.0% of patients, post-procedure grade ≥III residual aortic regurgitation was rare (1.2%), and the permanent pacemaker implantation (PPI) rate was 36.0%. At 30 days, the incidences of mortality and reintervention were 8.4% and 3.5%, respectively. The co-primary endpoint reached 41.6% (IQR 34.4-49.6) at 1 year, increased up to 61.8% (IQR 52.4-71.2) at 4 years, and was independently predicted by TS, with a hazard ratio of 0.45 (95% confidence interval: 0.27-0.76); p=0.003.Conclusions: TAVI with NGD in PAVR patients is efficient and reasonably safe. Preventing the need for an SVI embodies the major technical challenge. Larger implanted valves may have limited this complication, outweighing the increased risk of PPI. Despite successful TAVI, PAVR patients experience frequent CE at long-term follow-up