scholarly journals Variablity of Mechanical or Tissue Valve Implantation in Patients Undergoing Surgical Aortic Valve Replacement in Spain: National Retrospective Analysis from 2007 to 2018

2021 ◽  
Vol 10 (15) ◽  
pp. 3209
Author(s):  
Manuel Carnero-Alcázar ◽  
Emiliano Rodríguez-Caulo ◽  
Daniel Hernández-Vaquero ◽  
Lourdes Montero-Cruces ◽  
Daniel Perez-Camargo ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Artery Bypass ◽  
National Health System ◽  
Surgical Aortic Valve Replacement ◽  
Tissue Valve ◽  
Spanish National Health System ◽  
Grafting From ◽  
Valve Implantation

Background: There is no robust evidence regarding the types of valves implanted among patients undergoing surgical aortic valve replacement (SAVR) in Spain. Methods: All cases of patients undergoing SAVR ± coronary artery bypass grafting from January 2007 to December 2018 in the public Spanish National Health System were included. We analyzed the trends of SAVR volume, risk profile and type of implanted valve across time and place. Using multivariable logistic regression, we identified factors associated with biological SAVR. Results: In total, 62,870 episodes of SAVR in 15 Spanish territories were included. In 35,693 (56.8%), a tissue valve was implanted. The annual volume of procedures increased from 107.3/million (2007) to 128.6 (2017). In 2018, it fell to 108.5. Age increased and Charlson’s comorbity index worsened throughout the study period. Tissue valve implantation increased in most regions. After adjusting for other covariates, we observed a high variability in aortic valve implantation across different regions, with differences of as much as 20-fold in the use of tissue valves. Conclusions: Between 2007 and 2018, we detected a significant increase in the use of bioprostheses in patients undergoing SAVR in Spain, and a great variability in the types of valve between the Spanish territories, which was not explained by the different risk profiles of patients.

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.

Sutureless versus Stented Bioprostheses for Aortic Valve Replacement: The Randomized PERSIST-AVR Study Design

2018 ◽  
Vol 68 (02) ◽  
pp. 114-123 ◽  
Author(s):  
Roberto Lorusso ◽  
Thierry Folliguet ◽  
Malakh Shrestha ◽  
Bart Meuris ◽  
Arie Pieter Kappetein ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Severe Aortic Stenosis ◽  
Artery Bypass ◽  
Randomized Study ◽  
Primary Objective ◽  
Surgical Aortic Valve Replacement ◽  
Open Label ◽  
Number Of Patients

Abstract Introduction Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches. The stentless configuration of the sutureless valve was designed to achieve optimal hemodynamic performance. Materials and Methods PERSIST-AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement) is a prospective, randomized, adaptive, open-label, international, postmarket trial (NCT02673697). The primary objective of the trial is to assess the safety and efficacy of the Perceval (LivaNova, London, UK) sutureless bioprosthesis among patients undergoing SAVR in the presence of severe aortic stenosis to demonstrate the noninferiority of Perceval as compared with standard sutured stented bioprosthetic aortic valve as an isolated procedure or combined with coronary artery bypass grafting. Sample size will be determined adaptively through interim analyses performed by an Independent Statistical Unit till a maximum of 1,234 patients, enrolled at ∼60 sites in countries where the device is commercially available. Patients will be followed up for 5 years after implant. The primary end point is the number of patients free from major adverse cardiac and cerebrovascular-related events at 1 year. Additional secondary outcomes will be assessed up to 5 years. Discussion PERSIST-AVR is the first prospective, randomized study comparing in-hospital and postdischarge outcomes in a robust population of patients undergoing SAVR with either the Perceval sutureless bioprosthesis or a conventional sutured stented bioprosthesis up to 5 years.

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