EARLY HEMODYNAMIC RESULTS IN PATIENTS WITH SMALL AORTIC ANNULUS UNDERGOING SURGICAL SUTURELESS AORTIC VALVE REPLACEMENT (PERCEVAL) AND BALLOON-EXPANDABLE TRANSCATHETER AORTIC VALVE IMPLANTATION

2016 ◽  
Vol 32 (10) ◽  
pp. S305-S306
Author(s):  
P. Dionne ◽  
F. Poulin ◽  
P. Généreux ◽  
M. Carrier ◽  
R. Cartier ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Implantation ◽  
Aortic Annulus ◽  
Transcatheter Aortic Valve ◽  
Small Aortic Annulus ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Early Hemodynamic Results in Patients with Small Aortic Annulus after Aortic Valve Replacement

2017 ◽  
Vol 12 (4) ◽  
pp. 254-258 ◽  
Author(s):  
Pierre Olivier Dionne ◽  
Frédéric Poulin ◽  
Denis Bouchard ◽  
Philippe Généreux ◽  
Reda Ibrahim ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Implantation ◽  
Aortic Annulus ◽  
Transcatheter Aortic Valve ◽  
Significant Difference ◽  
Valve Size ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Objective Patients with a small aortic annulus (≤21 mm) have an increased risk of patient-prosthesis mismatch after valve replacement. The aim of this study was to compare the early hemodynamic performance of the balloon-expandable transaortic valve implantation Edwards system (SAPIEN) and the sutureless Perceval prostheses. Methods Fifty patients underwent transcatheter aortic valve implantation, and 113 patients underwent sutureless aortic valve replacement. Mean ± SD aortic annulus diameter was 19.7 ± 1 mm, with no significant difference between groups. SAPIEN valve size was 23 mm in 40 patients (80%) and 26 mm in 10 patients (20%). Perceval valve size was small in 45 patients (40%), medium in 62 patients (55%), and large in 6 patients (5%). Transthoracic Doppler echocardiographic images were collected at baseline and before discharge. Results There were no significant difference in predischarge effective orifice area (SAPIEN: 1.5 ± 0.5 cm2 and Perceval: 1.48 ± 0.34 cm2, P = 0.58) and indexed effective orifice areas (SAPIEN: 0.93 ± 0.32 cm2/m2 and Perceval: 0.88 ± 0.22 cm2/m2, P = 0.42). Predischarge mean ± SD transaortic gradient was lower with the SAPIEN than with Perceval valves (12 ± 6 and 17 ± 6 mm Hg, respectively, P < 0.001). Rates of moderate and severe prosthesis-patient mismatch were similar (SAPIEN: 44% and 10% and Perceval: 50% and 14%, P = 0.53 and 0.75, respectively). There were no moderate-severe paravalvular leaks. Conclusions Although indexed effective orifice areas were similar, transcatheter aortic valve implantation with the balloon-expandable SAPIEN system yielded lower predischarge transaortic mean gradients than the surgically implanted Perceval, in patients with a small annulus.

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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