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Influence of permanent pacemaker implantation after transcatheter aortic valve implantation with new-generation devices.

ABSTRACT: OBJECTIVE:Permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI) is the most common complication after the procedure. PPMI rates remain high with the new-generation TAVI devices despite improved outcomes concerning paravalvular aortic regurgitation and vascular access complications. However, the impact of PPMI on mortality and clinical outcome is still a matter of debate, and data with new-generation devices on this matter are scarce. Therefore, we sought to analyse the influence of PPMI in patients treated with the new-generation devices on one-year outcome. METHODS:We enrolled 612 consecutive patients without prior pacemaker undergoing transfemoral TAVI with the new-generation devices. Patients with or without PPMI were compared with respect to clinical outcome within one year. RESULTS:PPMI was performed in 168 patients (24.4% of the overall study population). There was no significant difference in one-year outcome concerning all-cause mortality (PPMI vs. no-PPMI: 12.2% vs. 12.5%, p?=?0.94), rate of major adverse events including cardiac, cerebral or valve-related events and bleeding complications (22.1% vs. 24.5%, p?=?0.55) or need for rehospitalisation due to cardiac symptoms (16.1% vs. 18.1%, p?=?0.63). In patients with reduced ejection fraction (<45%) there was also no impact of PPMI on one-year mortality (14.3% vs. 15.7%, p?=?0.86). Furthermore, multivariate analysis did not reveal PPMI to be independently associated with one-year mortality (odds ratio 0.94, 95% confidence interval 0.50-1.74, p?=?0.83). CONCLUSIONS:In this large all-comers TAVI population with new-generation devices the need for postprocedural PPMI did not show a statistical significant impact on survival or combined endpoint of major adverse events within one year.

SUBMITTER: Gonska B

PROVIDER: S-EPMC6288034 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Influence of permanent pacemaker implantation after transcatheter aortic valve implantation with new-generation devices.

Gonska B B Keßler M M Wöhrle J J Rottbauer W W Seeger J J

Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation 20181201 12

<h4>Objective</h4>Permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI) is the most common complication after the procedure. PPMI rates remain high with the new-generation TAVI devices despite improved outcomes concerning paravalvular aortic regurgitation and vascular access complications. However, the impact of PPMI on mortality and clinical outcome is still a matter of debate, and data with new-generation devices on this matter are scarce. Therefore, we s ...[more]

PMID: 30443709

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Project description:ImportanceThe literature is inconsistent regarding the impact of permanent pacemaker implantation after transcatheter aortic valve replacement.ObjectiveTo evaluate clinical and economic outcomes in patients who required permanent pacemaker implantation during the index hospitalization after transcatheter aortic valve replacement.Design, setting, and participantsThis retrospective, population-based cohort study using data from a multicenter registry included patients who underwent a transcatheter aortic valve replacement procedure from April 1, 2010, to March 31, 2015, in Ontario, Canada, with follow-up to March 31, 2017. Patients who had a previously implanted permanent pacemaker or who died during the index hospitalization were excluded. Inverse probability of treatment weighting using the propensity score was used to adjust for baseline differences between the pacemaker and nonpacemaker groups.ExposuresPatients received a permanent pacemaker during the index hospitalization after transcatheter aortic valve replacement.Main outcomes and measuresAll-cause mortality, readmission, readmission for heart failure, emergency department visits, and cumulative 1-year health care costs.ResultsThe study cohort consisted of 1263 patients (mean [SD] age, 82.3 [7.2] years; 595 [47.1%] female; 137 [10.8%] rural), of whom 186 (14.7%) required permanent pacemaker insertion during the index hospitalization after transcatheter aortic valve replacement. Mean follow-up was 990 days. After propensity score weighting, over the entire follow-up period, pacemaker implantation was associated with significantly higher all-cause mortality (43.9% vs 31.7%; hazard ratio [HR], 1.40; 95% CI, 1.01-1.94; P?=?.04), all-cause readmission (80.9% vs 70.6%; HR, 1.28; 95% CI, 1.15-1.43; P?<?.001), and emergency department visits (95.5% vs 87.3%; HR, 1.28; 95% CI, 1.08-1.52; P?=?.004). Pacemaker implantation was also associated with significantly greater readmission for heart failure (33.9% vs 19.1%; HR, 1.90; 95% CI, 1.53-2.36; P?<?.001). There were no statistically significant differences between groups in adjusted cumulative health care costs 1 year after discharge.Conclusions and relevanceNew permanent pacemaker implantation after transcatheter aortic valve replacement was associated with significantly greater morbidity and mortality at long-term follow-up. However, this did not translate to a difference in cumulative health care costs after hospital discharge.

Project description:ObjectiveTranscatheter aortic valve implantation (TAVI) procedures are increasing rapidly, but the durability of tissue valve and periprocedural complications are not satisfactory. Immune reaction to the galactose-α-1,3 galactose β-1,4-N-acetylglucosamine (α-Gal) and conventional processing protocols of cardiac xenografts lead to calcification. Next-generation TAVI needs to be made with α-Gal-free xenografts by multiple anticalcification therapies to avoid immune rejection and enhance durability, and three-dimensional (3D) printing technology to improve the procedural safety.MethodsPorcine pericardia were decellularized and immunologically modified with α-galactosidase. The pericardia were treated by space filler, crosslinked with glutaraldehyde in organic solvent, and detoxified. The sheep-specific nitinol (nickel-titanium memory alloy) wire backbone was made from a 3D-printed model for ovine aortic root. After it passed the fitting test, we manufactured a self-expandable stented valve with the porcine pericardia mounted on the customized nitinol wire-based stent. After in vitro circulation using customized silicone aortic root, we performed TAVI in 9 sheep and obtained hemodynamic, radiological, immunohistopathological, and biochemical results.ResultsThe valve functioned well, with excellent stent fitting and good coronary flow under in vitro circulation. Sheep were sequentially scheduled to be humanely killed until 238 days after TAVI. Echocardiography and cardiac catheterization demonstrated good hemodynamic status and function of the aortic valve. The xenografts were well preserved without α-Gal immune reaction or calcification based on the immunological, radiographic, microscopic, and biochemical examinations.ConclusionsWe proved preclinical safety and efficacy for next-generation α-Gal-free TAVI with multiple anticalcification therapies and 3D-printing technology. A future clinical study is warranted based on these promising preclinical results.

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Influence of permanent pacemaker implantation after transcatheter aortic valve implantation with new-generation devices.

Publications

Influence of permanent pacemaker implantation after transcatheter aortic valve implantation with new-generation devices.

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