scholarly journals The Role of Frailty in Identifying Benefit from Transcatheter Versus Surgical Aortic Valve Replacement

2021 ◽  
Author(s):  
Jordan B. Strom ◽  
Jiaman Xu ◽  
Ariela R. Orkaby ◽  
Changyu Shen ◽  
Yang Song ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Treatment Effect ◽  
Cox Regression ◽  
Frailty Index ◽  
Adverse Outcomes ◽  
Surgical Aortic Valve Replacement ◽  
Risk Of Death ◽  
Transcatheter Aortic Valve

Background: Frailty is associated with a higher risk for adverse outcomes after aortic valve replacement (AVR) for severe aortic valve stenosis, but whether or not frail patients derive differential benefit from transcatheter (TAVR) vs. surgical (SAVR) AVR is uncertain. Methods: We linked adults ≥ 65 years old in the US CoreValve High Risk (HiR) or Surgical or Transcatheter Aortic-Valve Replacement in Intermediate Risk Patients (SURTAVI) trial to Medicare claims, 2/2/2011-9/30/2015. Two frailty measures, a deficit-based (DFI) and phenotype-based (PFI) frailty index, were generated. The treatment effect of TAVR vs. SAVR was evaluated within frailty index (FI) tertiles for the primary endpoint of death and non-death secondary outcomes, using multivariable Cox regression. Results: Of 1,442 (linkage rate = 60.0%) individuals included, 741 (51.4%) individuals received TAVR and 701 (48.6%) received SAVR (mean age 81.8 ± 6.1 years, 44.0% female). Though 1-year death rates in the highest FI tertiles (DFI 36.7%, PFI 33.8%) were 2-3-fold higher than the lowest tertiles (DFI 13.4%, HR 3.02, 95% CI 2.26-4.02, p < 0.001; PFI 17.9%; HR 2.05, 95% CI 1.58-2.67, p < 0.001), there were no significant differences in the relative or absolute treatment effect of SAVR vs. TAVR across FI tertiles for all death, non-death, and functional outcomes (all interaction p-values > 0.05). Results remained consistent across individual trials, frailty definitions, and when considering the non-linked trial data. Conclusions: Two different frailty indices based on Fried and Rockwood definitions identified individuals at higher risk of death and functional impairment but no differential benefit from TAVR vs. SAVR.

scholarly journals Impact of new pacemaker implantation following surgical and transcatheter aortic valve replacement on 1-year outcome

2019 ◽  
Vol 57 (1) ◽  
pp. 151-159 ◽  
Author(s):  
Buntaro Fujita ◽  
Tobias Schmidt ◽  
Sabine Bleiziffer ◽  
Timm Bauer ◽  
Andreas Beckmann ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Cox Regression ◽  
Pacemaker Implantation ◽  
Surgical Aortic Valve Replacement ◽  
Cox Regression Analysis ◽  
Transcatheter Aortic Valve

Abstract OBJECTIVES The purpose of this study was to evaluate the incidence of new pacemaker implantation (NPMI) after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR), and investigate its influence on 1-year mortality. METHODS Patients who were enrolled in ‘The German Aortic Valve Registry’ undergoing isolated TAVR or SAVR between 2011 and 2015 were analysed. The rate of NPMI was analysed for both groups and multivariable Cox regression analysis was performed to investigate the possible independent association between NPMI and 1-year mortality. RESULTS Twenty thousand eight hundred and seventy-two patients who underwent TAVR and 17 750 patients who received SAVR were included in this study. The rate of NPMI was 16.6% after TAVR and 3.6% after SAVR. In the TAVR group, NPMI was associated with significantly increased 1-year mortality in univariable Cox regression analysis [hazard ratio (HR) 1.29, confidence interval (CI) 1.18–1.41; P &lt; 0.001]. This association persisted after adjustment for confounding factors (HR 1.29, CI 1.16–1.43; P &lt; 0.001). In the SAVR group, NPMI significantly increased 1-year mortality in univariable analysis as well (HR 1.55, CI 1.08–2.22; P = 0.02), whereas after multivariable adjustment, NPMI did not emerge as an independent risk factor (HR 1.29, 0.88–1.89; P = 0.19). NPMI was not associated with 30-day mortality in both procedure groups. CONCLUSIONS The rate of NPMI was markedly higher after TAVR compared with SAVR and was independently associated with 1-year mortality after TAVR, whereas this was not significant after SAVR. As 30-day mortality was not different for TAVR and SAVR, the subsequent procedure of an NPMI itself seems not to increase the risk of mortality.

scholarly journals Valve-in-Valve Transcatheter Aortic Valve Replacement Versus Redo Surgical Aortic Valve Replacement

2021 ◽  
Vol 14 (2) ◽  
pp. 211-220 ◽  
Author(s):  
Michel Pompeu B.O. Sá ◽  
Jef Van den Eynde ◽  
Matheus Simonato ◽  
Luiz Rafael P. Cavalcanti ◽  
Ilias P. Doulamis ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Surgical Aortic Valve Replacement ◽  
Transcatheter Aortic Valve ◽  
Valve In Valve

scholarly journals Bias estimation in study design: a meta-epidemiological analysis of transcatheter versus surgical aortic valve replacement

BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Saerom Youn ◽  
Shannon Avery Wong ◽  
Caitlin Chrystoja ◽  
George Tomlinson ◽  
Harindra C. Wijeysundera ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Implantation ◽  
Treatment Effects ◽  
Surgical Aortic Valve Replacement ◽  
High Quality ◽  
Transcatheter Aortic Valve ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Background Paucity of RCTs of non-drug technologies lead to widespread dependence on non-randomized studies. Relationship between nonrandomized study design attributes and biased estimates of treatment effects are poorly understood. Our purpose was to estimate the bias associated with specific nonrandomized study attributes among studies comparing transcatheter aortic valve implantation with surgical aortic valve replacement for the treatment of severe aortic stenosis. Results We included 6 RCTs and 87 nonrandomized studies. Surgical risk scores were similar for comparison groups in RCTs, but were higher for patients having transcatheter aortic valve implantation in nonrandomized studies. Nonrandomized studies underestimated the benefit of transcatheter aortic valve implantation compared with RCTs. For example, nonrandomized studies without adjustment estimated a higher risk of postoperative mortality for transcatheter aortic valve implantation compared with surgical aortic valve replacement (OR 1.43 [95% CI 1.26 to 1.62]) than high quality RCTs (OR 0.78 [95% CI 0.54 to 1.11). Nonrandomized studies using propensity score matching (OR 1.13 [95% CI 0.85 to 1.52]) and regression modelling (OR 0.68 [95% CI 0.57 to 0.81]) to adjust results estimated treatment effects closer to high quality RCTs. Nonrandomized studies describing losses to follow-up estimated treatment effects that were significantly closer to high quality RCT than nonrandomized studies that did not. Conclusion Studies with different attributes produce different estimates of treatment effects. Study design attributes related to the completeness of follow-up may explain biased treatment estimates in nonrandomized studies, as in the case of aortic valve replacement where high-risk patients were preferentially selected for the newer (transcatheter) procedure.

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