Dataset Information

Long-term clinical impact of permanent pacemaker implantation in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis.

ABSTRACT:

Aims

The aims of this study is to assess by an updated meta-analysis the clinical outcomes related to permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) at long-term (≥12 months) follow-up (LTF).

Methods and results

A comprehensive literature research was performed on PubMed and EMBASE. The primary endpoint was all-cause death. Secondary endpoints were rehospitalization for heart failure, stroke, and myocardial infarction. A subgroup analysis was performed according to the Society of Thoracic Surgeon-Predicted Risk of Mortality (STS-PROM) score. This study is registered with PROSPERO (CRD42021243301). A total of 51 069 patients undergoing TAVI from 31 observational studies were included. The mean duration of follow-up was 22 months. At LTF, PPI post-TAVI was associated with a higher risk of all-cause death [risk ratio (RR) 1.18, 95% confidence interval (CI) 1.10-1.25; P < 0.001] and rehospitalization for heart failure (RR 1.32, 95% CI 1.13-1.52; P < 0.001). In contrast, the risks of stroke and myocardial infarction were not affected. Among the 20 studies that reported procedural risk, the association between PPI and all-cause death risk at LTF was statistically significant only in studies enrolling patients with high STS-PROM score (RR 1.25, 95% CI 1.12-1.40), although there was a similar tendency of the results in those at medium and low risk.

Conclusion

Patients necessitating PPI after TAVI have a higher long-term risk of all-cause death and rehospitalization for heart failure as compared to those who do not receive PPI.

SUBMITTER: Zito A

PROVIDER: S-EPMC9460982 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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Publications

Long-term clinical impact of permanent pacemaker implantation in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis.

Zito Andrea A Princi Giuseppe G Lombardi Marco M D'Amario Domenico D Vergallo Rocco R Aurigemma Cristina C Romagnoli Enrico E Pelargonio Gemma G Bruno Piergiorgio P Trani Carlo C Burzotta Francesco F Crea Filippo F

Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology 20220701 7

<h4>Aims</h4>The aims of this study is to assess by an updated meta-analysis the clinical outcomes related to permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) at long-term (≥12 months) follow-up (LTF).<h4>Methods and results</h4>A comprehensive literature research was performed on PubMed and EMBASE. The primary endpoint was all-cause death. Secondary endpoints were rehospitalization for heart failure, stroke, and myocardial infarction. A subgroup analys ...[more]

PMID: 35138367

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Project description:ObjectivePermanent pacemaker implantation (PPI) risk is higher following transcatheter aortic valve implantation (TAVI) than surgical valve replacement. Native aortic leaflets are retained in patients undergoing TAVI, unlike in surgical valve replacement. Whether the retained leaflets influence PPI risk because of their proximity to the conduction system is unknown. The study sought to determine the association between infra-annular extension of native right coronary cusp/noncoronary cusp (RCC/NCC) post balloon-expandable TAVI and PPI risk.MethodsWe performed a retrospective analysis of 190 patients undergoing balloon-expandable TAVI at a single center. Manifestation of infra-annular extension of RCC/NCC was considered to be present when part of leaflet extended below aortic-annular plane on post-implantation aortic-root angiography.ResultsInfra-annular extension of RCC/NCC was observed in 33 patients (17.37%). PPI incidence post-TAVI was higher in patients with infra-annular extension of RCC/NCC than in those without (36.36% versus 8.92%, relative-risk: 4.08, p˂0.0001). On logistic-regression analysis, preexisting right bundle-branch block (RBBB) (odds-ratio: 12.73, 95% confidence-interval: 2.16-74.93, p = 0.005), and infra-annular extension of RCC/NCC (odds-ratio: 5.63, 95% confidence-interval: 2.17-14.58, p < 0.0001) were independently associated with PPI risk. Preexisting RBBB (φ = +0.25, p = 0.001) and infra-annular extension of RCC/NCC (φ = +0.30, p < 0.0001) showed a positive-correlation with PPI risk. Infra-annular extension of RCC/NCC was a significant predictor of PPI risk on receiver-operating-characteristic curve analysis (area under-the-curve 0.67; 95% confidence-interval: 0.54-0.79, p = 0.006).ConclusionThe retained native aortic leaflets play a significant role in PPI risk following balloon-expandable TAVI. Infra-annular extension of RCC/NCC is a novel predictor, and is associated with a four-fold higher risk of PPI.

Project description:ImportancePrior studies investigating the long-term clinical outcomes of patients who have undergone permanent pacemaker implantation after aortic valve replacement reported conflicting results.ObjectiveTo investigate long-term outcomes after primary surgical aortic valve replacement among patients who underwent postoperative permanent pacemaker implantation.Design, setting, and participantsThis cohort study included all patients who underwent surgical aortic valve replacement in Sweden from 1997 to 2018. All patients who underwent primary surgical aortic valve replacement in Sweden and survived the first 30 days after surgical treatment were included. Patients who underwent preoperative permanent pacemaker implantation, concomitant surgical treatment for another valve, or emergency surgical treatment were excluded. Patients who underwent concomitant coronary artery bypass grafting or surgical treatment of the ascending aorta were included. Follow-up data were complete for all patients. Data were analyzed from October through December 2020.ExposuresPatients underwent implantation of a permanent pacemaker or implantable cardioverter defibrillator within 30 days after aortic valve replacement.Main outcomes and measuresThe primary outcome was all-cause mortality.ResultsAmong 24 983 patients who underwent surgical aortic valve replacement, 849 patients (3.4%) underwent permanent pacemaker implantation within 30 days after surgical treatment and 24 134 patients (96.6%) did not receive pacemakers in that time. The mean (SD) age of the total study population was 69.7 (10.8) years, and 9209 patients were women (36.9%). The mean (SD) and maximum follow-up periods were 7.3 (5.0) years and 22.0 years, respectively. At 10 years and 20 years after surgical treatment, the Kaplan-Meier estimated survival rates were 52.8% and 18.0% in the pacemaker group, respectively, and 57.5% and 19.6% in the nonpacemaker group, respectively. All-cause mortality was statistically significantly increased in the pacemaker group compared with the nonpacemaker group (hazard ratio [HR], 1.14; 95% CI, 1.01-1.29; P = .03), and so was risk of heart failure hospitalization (HR, 1.58; 95% CI, 1.31-1.89; P < .001). No statistically significant increase was found in the risk of endocarditis in the pacemaker group.Conclusions and relevanceThis study found that there were increased risks of all-cause mortality and heart failure hospitalization among patients who underwent permanent pacemaker implantation after surgical aortic valve replacement, suggesting that these risks are important considerations, especially in an era when transcatheter aortic valve replacement is used in younger patients at lower risk of adverse surgical outcomes. These findings further suggest that future research should investigate how to avoid permanent pacemaker dependency after surgical and transcatheter aortic valve replacement.

Project description:ObjectivesThe primary objectives were to identify the predictors of new permanent pacemaker implantation in patients with aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). The secondary objectives were to investigate the temporal changes in permanent pacemaker implantation following TAVI and its impact on long-term prognosis.DesignProspective observational cohort study of patients with AS undergoing TAVI.SettingSingle-centre study conducted at a tertiary hospital in Western Norway between 2012 and 2019.ParticipantsAmong 600 consecutive patients with severe AS who were treated with TAVI, 52 patients with permanent pacemaker prior to TAVI were excluded. The remaining 548 patients were included in the present study.Baseline measuresAn evaluation of baseline risk factors, 12-lead ECG and echocardiography.Primary outcome measuresThe need for a new pacemaker implantation ≤30 days following TAVI and all-cause death.ResultsThe mean age was 80.6±6.7 years, and 50% were males. Among the 548 eligible patients, 173 (31.6%) underwent pacemaker implantation ≤30 days following TAVI, evenly distributed between females and males (29.6% vs 33.6%, p=0.317), with higher implant rates at low-volume phase (2012-2015) and lower implant rates at high-volume phase (2016-2019) (45.8% vs 23.9%, p<0.001). On multivariable analysis, an abnormal electrocardiogram (OR 1.73; 95% CI 1.14 to 2.63, p=0.010), right bundle branch block (OR 2.23; 95% CI 1.09 to 4.59, p=0.028) and atrial fibrillation (OR 1.89; 95% CI 1.24 to 2.88, p=0.003) at baseline were strong predictors of pacemaker implantation. The type of bioprosthesis, but not size, was associated with permanent pacemaker implantation (mechanically expandable valves OR 3.48, 95% CI 2.16 to 5.59; balloon-expandable valves OR 0.07, 95% CI 0.02 to 0.29, both p<0.001)-irrespective of age and sex. During a median follow-up of 60.4 months (range 3-131 months), permanent pacemaker implantation following TAVI was not associated with all-cause mortality (HR 0.89; 95% CI 0.69 to 1.16, p=0.403).ConclusionsIn the current study, the rates of permanent pacemaker implantation following TAVI decreased substantially from the early low-volume phase to the late high-volume phase. An abnormal baseline ECG, right bundle branch block, atrial fibrillation and bioprosthesis selection remained important predictors of permanent pacemaker implantation. Permanent pacemaker implantation following TAVI had no impact on short or long-term survival.Ethics and disseminationThe Regional Committees for Medical and Health Research Ethics (approval number: REK vest 33814/2019) and the Institutional Data Protection Services approved the study protocol. The dissemination of study findings was through peer-reviewed publication, presentation at national and international scientific meetings and conferences.Trial registration numberNCT04417829.

Dataset Information

Long-term clinical impact of permanent pacemaker implantation in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis.

Aims

Methods and results

Conclusion

Publications

Long-term clinical impact of permanent pacemaker implantation in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis.

Similar Datasets

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