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Aortic valve replacement using stented or sutureless/rapid deployment prosthesis via either full-sternotomy or a minimally invasive approach: a network meta-analysis.

ABSTRACT: Background:New technologies such as sutureless or rapid deployment prosthetic valves and access via minimally invasive incisions offer alternatives to traditional full-sternotomy aortic valve replacement (SAVR). However, a comprehensive comparison of these surgical techniques along with alternative valve prosthesis has not been completed. Methods:Electronic databases were searched for studies comparing outcomes for SAVR, minimally invasive AVR (MiAVR), sutureless/rapid-deployment AVR (SuAVR) via full-sternotomy, or minimally invasive SuAVR (MiSuAVR) from their inception until September 2018. Early postoperative outcomes and follow-up data were included in a Bayesian network meta-analysis. Results:Twenty-three studies with 8,718 patients were identified. Compared with standard SAVR, SuAVR had significantly lower incidence of postoperative AF [odds ratio (OR) 0.33, 95% confidence interval (CI): 0.14-0.79, P=0.013] and MiSuAVR greater requirement for postoperative permanent pacemaker (OR 2.27, 95% CI: 1.25-4.14, P=0.008). All sutureless/rapid-deployment procedures had reduced cardiopulmonary bypass and cross-clamp times, by a mean of 25.9 and 25.0 min, respectively. Hospital length of stay (LOS), but not intensive care LOS, was reduced for all groups (MiAVR -1.53 days, MiSuAVR -2.79 days, and SuAVR 3.37 days). A signal towards reduced early mortality, wound infections, and acute kidney injury was noted in both sutureless/rapid-deployment and minimally invasive techniques but did not achieve significance. Sutureless/rapid-deployment procedures had favourable survival and freedom from valve related reoperation, however follow-up times were short and demonstrated significant heterogeneity between intervention groups. Conclusions:Minimally invasive and sutureless techniques demonstrate equivalent early postoperative outcomes to SAVR and may reduce ventilation time, hospital LOS and postoperative atrial fibrillation (POAF) burden.

SUBMITTER: Woldendorp K

PROVIDER: S-EPMC7548209 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Aortic valve replacement using stented or sutureless/rapid deployment prosthesis via either full-sternotomy or a minimally invasive approach: a network meta-analysis.

Woldendorp Kei K Doyle Mathew P MP Bannon Paul G PG Misfeld Martin M Yan Tristan D TD Santarpino Giuseppe G Berretta Paolo P Di Eusanio Marco M Meuris Bart B Cerillo Alfredo Giuseppe AG Stefàno Pierluigi P Marchionni Niccolò N Olive Jacqueline K JK Nguyen Tom C TC Solinas Marco M Bianchi Giacomo G

Annals of cardiothoracic surgery 20200901 5

<h4>Background</h4>New technologies such as sutureless or rapid deployment prosthetic valves and access via minimally invasive incisions offer alternatives to traditional full-sternotomy aortic valve replacement (SAVR). However, a comprehensive comparison of these surgical techniques along with alternative valve prosthesis has not been completed.<h4>Methods</h4>Electronic databases were searched for studies comparing outcomes for SAVR, minimally invasive AVR (MiAVR), sutureless/rapid-deployment ...[more]

PMID: 33102174

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Project description:Degenerative aortic stenosis is the most frequent valvular heart disease in industrialized countries. Conservative treatment may beneficially influence symptoms but is never successful. Surgical aortic valve replacement (SAVR) was the only recognized treatment option to provide substantially prolonged survival until 2008. Operative mortality of isolated SAVR has been reported as low as 0.5% to 1% in experienced institutions, while long-term survival is close to that observed in a control healthy population of similar age. A multitude of studies have demonstrated the beneficial effects of SAVR with regard to improvement in quality of life and physical performance in the majority of symptomatic patients. In the last decade, transcatheter aortic valve implantation (TAVI) has emerged as an equal treatment modality, first in patients with high surgical risk and more recently in patients with intermediate and low surgical risk. Paravalvular regurgitation and the higher rate of pacemaker implantation remain points of consideration. Additionally, the long-term durability of TAVI devices and occurrence of stroke late after TAVI require additional analyses. Sutureless (SU-SAVR) and rapid deployment valve (R-SAVR) were designed to simplify and accelerate a conventional or less invasive surgical procedure while allowing complete excision of the calcified native valve. From 3 different implants tested more than 10 to 15 years ago, only two are available on the market today: the Perceval® valve from Liva Nova and the Intuity® sutureless prosthesis from Edwards Lifesciences. There has been extensive experience with these two devices in previous years and the results obtained are comparable to those observed following the use of conventional implants. The sutureless devices may be of particular interest for more complex and combined surgical procedures. This review summarizes the sutureless (SU-SAVR) and rapid deployment valve technologies and presents a clinical outlook for the patient population managed with these devices.

Project description:Background:Although sutureless and rapid deployment aortic valve replacement (SURD-AVR) has been associated with an increased rate of permanent pacemaker (PPM) implantation compared to conventional AVR (c-AVR), the predictors of new conduction abnormalities remain to be clarified. This study aimed to identify risk factors for conduction disorders in patients undergoing AVR surgery. Methods:Data from 243 patients receiving minimally invasive AVR were prospectively collected. SURD-AVR was performed in 103 (42.4%) patients and c-AVR in 140 (57.6%). The primary endpoint was the occurrence of new-onset conduction disorders, defined as first degree atrioventricular (AV) block, advanced AV block requiring PPM implantation, left anterior fascicular block (LAFB), left bundle branch block (LBBB) and right bundle branch block (RBBB). Results:The unadjusted comparison revealed that SURD-AVR was associated with a higher rate of advanced AV block requiring PPM when compared with c-AVR (10.5% vs. 2.1%, P=0.01). After adjusting for other measured covariates (OR: 1.6, P=0.58) and for the estimated propensity of SURD-AVR (OR: 5.1, P=0.1), no significant relationship between type of AVR and PPM implantation emerged. On multivariable analysis, preoperative first-degree AV block (OR: 6.9, P=0.04) and RBBB (OR: 6.9, P=0.03) were independent risk factors for PPM. Subgroup analysis of patients with normal preoperative conduction revealed similar incidence of PPM between SURD-AVR and c-AVR (1.3% vs. 1.9%, P=0.6). When compared with c-AVR, SURD-AVR was associated with a greater incidence of postoperative new onset LBBB (18.1% vs. 3.2%, P<0.001). This finding was confirmed after adjusting for the estimated propensity of SURD-AVR (OR: 6.3, P=0.009). Conclusions:Our study revealed that the risk of PPM implantation in patients receiving surgical AVR is heavily influenced by the presence of pre-existing conduction disturbances rather than the type of valve prosthesis. Conversely, SURD-AVR emerged as an independent predictor for LBBB and was associated with an increased risk of PPM in patients presenting with RBBB.

Project description:BackgroundPrevious studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system.ObjectivesThe goal of this study was to evaluate the cost-effectiveness of TAVR with a self-expanding prosthesis compared with surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and high surgical risk.MethodsWe performed a formal economic analysis on the basis of individual, patient-level data from the CoreValve U.S. High Risk Pivotal Trial. Empirical data regarding survival and quality of life over 2 years, and medical resource use and hospital costs through 12 months were used to project life expectancy, quality-adjusted life expectancy, and lifetime medical costs in order to estimate the incremental cost-effectiveness of TAVR versus SAVR from a U.S.ResultsRelative to SAVR, TAVR reduced initial length of stay an average of 4.4 days, decreased the need for rehabilitation services at discharge, and resulted in superior 1-month quality of life. Index admission and projected lifetime costs were higher with TAVR than with SAVR (differences $11,260 and $17,849 per patient, respectively), whereas TAVR was projected to provide a lifetime gain of 0.32 quality-adjusted life-years ([QALY]; 0.41 LY) with 3% discounting. Lifetime incremental cost-effectiveness ratios were $55,090 per QALY gained and $43,114 per LY gained. Sensitivity analyses indicated that a reduction in the initial cost of TAVR by ∼$1,650 would lead to an incremental cost-effectiveness ratio <$50,000/QALY gained.ConclusionsIn a high-risk clinical trial population, TAVR with a self-expanding prosthesis provided meaningful clinical benefits compared with SAVR, with incremental costs considered acceptable by current U.S.StandardsWith expected modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve U.S. Pivotal Trial]; NCT01240902).

Dataset Information

Aortic valve replacement using stented or sutureless/rapid deployment prosthesis via either full-sternotomy or a minimally invasive approach: a network meta-analysis.

Publications

Aortic valve replacement using stented or sutureless/rapid deployment prosthesis via either full-sternotomy or a minimally invasive approach: a network meta-analysis.

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