Sutureless Valve in Repeated Aortic Valve Replacement: Results from an International Prospective Registry

Author(s):  
Mattia Glauber ◽  
William D.T. Kent ◽  
George Asimakopoulos ◽  
Giovanni Troise ◽  
Josep Maria Padrò ◽  
...  

Objective To report early and midterm results registry of patients undergoing repeated aortic valve replacement (RAVR) with sutureless prostheses from an international prospective registry (SURE-AVR). Methods Between March 2011 and June 2019, 69 patients underwent RAVR with self-expandable sutureless aortic bioprostheses at 22 international cardiac centers. Results Overall mortality was 2.9% with a predicted logistic EuroSCORE II of 10.7%. Indications for RAVR were structural valve dysfunction (84.1%) and infective prosthetic endocarditis (15.9%) and were performed in patients with previously implanted bioprostheses (79.7%), mechanical valves (15.9%), and transcatheter valves (4.3%). Minimally invasive approach was performed in 15.9% of patients. Rate of stroke was 1.4% and rate of early valve-related reintervention was 1.4%. Overall survival rate at 1 and 5 years was 97% and 91%, respectively. No major paravalvular leak occurred. Rate of pacemaker implantation was 5.8% and 0.9% per patient-year early and at follow-up, respectively. The mean transvalvular gradient at 1-year and 5-year follow-up was 10.5 mm Hg and 11.5 mm Hg with a median effective orifice area of 1.8 cm2and 1.8 cm2, respectively. Conclusions RAVR with sutureless valves is a safe and effective approach and provides excellent clinical and hemodynamic results up to 5 years.

Author(s):  
Hossein Amirjamshidi ◽  
Courtney Vidovich ◽  
Ariana Goodman ◽  
Peter A. Knight

Objective The aim of this study is to evaluate early and intermediate outcomes and hemodynamics of the latest-generation Trifecta valve implanted using right anterior minithoracotomy. Methods We performed a single-center, retrospective, observational study including 175 individuals who underwent isolated minimally invasive aortic valve replacement with the latest-generation Trifecta valves through a right anterior minithoracotomy between January 2016 and January 2019. Exclusion criteria for follow-up echocardiographic study included concomitant procedures, conversion to median sternotomy, and nonsurvival during the index admission. Analyses addressed implantation safety, 30-day and intermediate-term survival and hemodynamic performance of the valves. Results Overall, patients were followed with duration ranging from 0.5 to 3 years. Early (<30 days) mortality occurred in 2 patients (1.1%), and there were 9 (5.1%) late (>30 days) deaths. Early thromboembolic events and postoperative bleeding requiring reoperation occurred at a rate of 4.0% ( n = 7) and 6.2% ( n = 11), respectively. Overall in 175 patients who met inclusion criteria for the follow-up echocardiography study, mean gradients across all valve sizes were 41.3 ± 14.9 (standard deviation) mm Hg preoperatively and remained low at 7.2 ± 3.9 mm Hg with mean effective orifice area of 1.8 ± 0.5 cm2 on the last follow-up echo. There was 1 case of infective prosthetic endocarditis, which did not require valve explant. There were no reoperations due to valve-related problems during the study period. Conclusions This is the largest series reporting on outcomes of the latest-generation Trifecta valve implanted using right anterior minithoracotomy. Our results demonstrate that this valve can be safely implanted via a minimally invasive approach with excellent early and intermediate outcomes and hemodynamic performance.


Author(s):  
Mattia Glauber ◽  
Lorenzo Di Bacco ◽  
Jose Cuenca ◽  
Roberto Di Bartolomeo ◽  
Max Baghai ◽  
...  

Objective To report the early and mid-term results of patients who underwent minimally invasive aortic valve replacement (MI-AVR) with a sutureless prosthesis from an international prospective registry. Methods Between March 2011 and September 2018, among 957 patients included in the prospective observational SURE-AVR (Sorin Universal REgistry on Aortic Valve Replacement) registry, 480 patients underwent MI-AVR with self-expandable Perceval aortic bioprosthesis (LivaNova PLC, London, UK) in 29 international institutions through either minithoracotomy ( n = 266) or ministernotomy ( n = 214). Postoperative, follow-up, and echocardiographic outcomes were analyzed for all patients. Results Patient age was 76.1 ± 7.1 years; 64.4% were female. Median EuroSCORE I was 7.9% (interquartile range [IQR], 4.8 to 10.9). Median cardiopulmonary bypass and cross-clamp times were 81 minutes (IQR 64 to 100) and 51 minutes (IQR 40 to 63). First successful implantation was achieved in 97.9% of cases. Two in-hospital deaths occurred, 1 for noncardiovascular causes and 1 following a disabling stroke. In the early (≤30 days) period, stroke rate was 1.4%. Three early explants were reported: 2 due to nonstructural valve dysfunction (NSVD) and 1 for malpositioning. One mild and 1 moderate paravalvular leak were reported. In 16 patients (3.3%) pacemaker implantation was needed. Mean follow-up was 2.4 years (maximum = 7 years). During follow-up 5 explants were reported, 3 due to endocarditis and 2 due to NSVD. Follow-up stroke rate was 2.5%. Three structural valve deteriorations not requiring reintervention were reported. Five-year survival was 91.45%. Conclusions In this large prospective international registry, MI-AVR with Perceval valve confirmed to be safe, reproducible, and effective in an intermediate-risk population, providing excellent clinical recovery both in early and mid-term follow-up.


Author(s):  
Giovanni Concistrè ◽  
Giuseppe Santarpino ◽  
Steffen Pfeiffer ◽  
Pierandrea Farneti ◽  
Antonio Miceli ◽  
...  

Objective Important comorbid conditions in patients referred for aortic valve replacement (AVR) require less invasive strategies. We describe our initial experience with the Perceval S (Sorin Group, Saluggia, Italy) and 3f Enable (Medtronic, Minneapolis, MN USA) sutureless aortic bioprostheses. Methods We compared intraoperative data, postoperative clinical outcomes, and echocardiographic results from patients receiving a Perceval S ( P group; n = 97) or a 3f Enable (E group; n = 32) prosthesis in two cardiac surgery departments (Nuremberg, Germany, and Massa, Italy). Results Baseline patient characteristics were similar in both groups, except for mean ± SD body surface area ( P group = 2.01 ± 2.9 m2, E group = 1.83 ± 3.8 m2; P < 0.001). Sixty-five patients (67%) in the P group and 19 patients (59.5%) in the E group ( P = 0.22) underwent minimally invasive AVR with either ministernotomy or right anterior minithoracotomy approach. Concomitant procedures were performed in 37 patients (38%) in the P group and 9 patients (28%) in the E group ( P = 0.56). In-hospital mortality was 2%. The mean ± SD prosthesis diameter was 23.5 ± 1.4 mm ( P group) compared with 22.1 ± 2 mm (E group) ( P < 0.001). In isolated AVR, aortic cross-clamp time was 36 ± 12.7 minutes in the P group and 66 ± 18 minutes in the E group ( P < 0.001). At a mean ± SD follow-up of 8.3 ± 4.5 months, survival was 97% (one death in the P group). In five patients ( P group = 1, E group = 4), a moderate paravalvular leak was present ( P = 0.013). The mean ± SD transvalvular gradient was 9.1 ± 3.3 mm Hg with the Perceval S and 11.2 ± 5.2 mm Hg with the 3f Enable ( P = 0.017). Conclusions Aortic valve replacement with sutureless aortic bioprosthesis is feasible, also with a minimally invasive approach. The Perceval S showed lower operative times and moderate paravalvular leaks and lower mean transvalvular gradients than did the 3f Enable, related to the larger diameter of the Perceval S implanted. Both prostheses showed an excellent hemodynamic performance. This new technology needs long-term follow-up.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Charbel Abi Khalil ◽  
Barbara Ignatiuk ◽  
Guliz Erdem ◽  
Hiam Chemaitelly ◽  
Fabio Barilli ◽  
...  

AbstractTranscatheter aortic valve replacement (TAVR) has shown to reduce mortality compared to surgical aortic valve replacement (sAVR). However, it is unknown which procedure is associated with better post-procedural valvular function. We conducted a meta-analysis of randomized clinical trials that compared TAVR to sAVR for at least 2 years. The primary outcome was post-procedural patient-prosthesis-mismatch (PPM). Secondary outcomes were post-procedural and 2-year: effective orifice area (EOA), paravalvular gradient (PVG) and moderate/severe paravalvular leak (PVL). We identified 6 trials with a total of 7022 participants with severe aortic stenosis. TAVR was associated with 37% (95% CI [0.51–0.78) mean RR reduction of post-procedural PPM, a decrease that was not affected by the surgical risk at inclusion, neither by the transcatheter heart valve system. Postprocedural changes in gradient and EOA were also in favor of TAVR as there was a pooled mean difference decrease of 0.56 (95% CI [0.73–0.38]) in gradient and an increase of 0.47 (95% CI [0.38–0.56]) in EOA. Additionally, self-expandable valves were associated with a higher decrease in gradient than balloon ones (beta = 0.38; 95% CI [0.12–0.64]). However, TAVR was associated with a higher risk of moderate/severe PVL (pooled RR: 9.54, 95% CI [5.53–16.46]). All results were sustainable at 2 years.


2021 ◽  

Reoperations for a dysfunctional mechanical aortic valve prosthesis are usually performed with a repeat sternotomy. Reopening the chest may be associated with a heart structure tear, bleeding, excessive transfusion, and a possible unfavorable outcome. Experience performing a redo aortic valve replacement with a minimally invasive approach and avoiding lysis of the pericardial adhesions is growing. We describe a redo aortic valve replacement procedure performed because of subvalvular pannus formation in a patient with a mechanical prosthesis. A partial J-shaped hemisternotomy at the 3rd intercostal space was performed; the ascending aorta was exposed and the valve was replaced with a sutureless bioprosthesis. The video tutorial shows the surgical approach, cardiopulmonary bypass solutions, and sutureless valve deployment.


2020 ◽  
Vol 31 (3) ◽  
pp. 398-404
Author(s):  
Samuli J Salmi ◽  
Tuomo Nieminen ◽  
Juha Hartikainen ◽  
Fausto Biancari ◽  
Joonas Lehto ◽  
...  

Abstract OBJECTIVES We sought to study the indications, long-term occurrence, and predictors of permanent pacemaker implantation (PPI) after isolated surgical aortic valve replacement with bioprostheses. METHODS The CAREAVR study included 704 patients (385 females, 54.7%) without a preoperative PPI (mean ± standard deviation age 75 ± 7 years) undergoing isolated surgical aortic valve replacement at 4 Finnish hospitals between 2002 and 2014. Data were extracted from electronic patient records. RESULTS The follow-up was median 4.7 years (range 1 day to 12.3 years). Altogether 56 patients received PPI postoperatively, with the median 507 days from the operation (range 6 days to 10.0 years). The PPI indications were atrioventricular block (31 patients, 55%) and sick sinus syndrome (21 patients, 37.5%). For 4 patients, the PPI indication remained unknown. A competing risks regression analysis (Fine–Gray method), adjusted with age, sex, diabetes, coronary artery disease, preoperative atrial fibrillation (AF), left ventricular ejection fraction, New York Heart Association class, AF at discharge and urgency of operation, was used to assess risk factors for PPI. Only AF at discharge (subdistribution hazard ratio 4.34, 95% confidence interval 2.34–8.03) was a predictor for a PPI. CONCLUSIONS Though atrioventricular block is the major indication for PPI after surgical aortic valve replacement, &gt;30% of PPIs are implanted due to sick sinus syndrome during both short-term follow-up and long-term follow-up. Postoperative AF versus sinus rhythm conveys &gt;4-fold risk of PPI. Clinical trial registration clinicaltrials.gov Identifier: NCT02626871


Author(s):  
Sven Martens ◽  
Andreas Zierer ◽  
Anja Ploss ◽  
Sami Sirat ◽  
Aleksandra Miskovic ◽  
...  

Objective For elderly patients with symptomatic aortic valve stenosis, aortic valve replacement with tissue valves is still the treatment of choice. Stentless valves were introduced to clinical practice for better hemodynamic features as compared with stented tissue valves. However, the implantation is more complex and time demanding, especially in minimal invasive aortic valve replacement. We present our clinical data on 22 patients having received a sutureless ATS 3f Enable aortic bioprosthesis via partial upper sternotomy. Methods The procedure was performed using CPB with cardioplegic arrest. After resection of the stenotic aortic valve and debridement of the annulus, the valve was inserted and released. Mean age was 79 years, and mean logistic Euroscore was 13. Subvalvular myectomy was performed in two patients. Prosthetic valve sizes were 19 mm (n = 1), 21 mm (n = 7), 23 mm (n = 6), 25 mm (n = 6), and 27 mm (n = 2). Results Implantation of the valve required 10 ± 6 minutes. Cardiopulmonary bypass and aortic crossclamp time were 87 ± 16 and 55 ± 11 minutes, respectively. Early mortality (<90 days) was 9% (2 patients). No paravalvular leakage was detected intraoperatively or in follow-up echocardiography. The mean transvalvular gradients were 9 ± 6 mm Hg at discharge and 8 ± 2 mm Hg at 1-year follow-up. Conclusions Sutureless valve implantation via partial sternotomy is feasible and safe with the ATS 3f Enable bioprosthesis. Reduction of cardiopulmonary bypass and aortic crossclamp time seems possible with increasing experience. Hemodynamic data are very promising with low gradients at discharge and after 12 month. Sutureless valve implantation via minimal invasive access may be an alternative treatment option for elderly patients with high comorbidity.


Author(s):  
Eiki Nagaoka ◽  
Keita Sato ◽  
Ali Hage ◽  
Rodrigo Bagur ◽  
Christopher Harle ◽  
...  

Sutureless aortic valve replacement (AVR) is a wide-spreading new technology that provides short clamping time and excellent hemodynamic outcomes. However, among its possible complications is the risk of paravalvular leak. We present the case of a 63-year-old woman who underwent minimally invasive right mini-thoracotomy AVR) with Perceval S sutureless valve (LivaNova, London, UK). Intraoperative transesophageal echocardiography revealed severe paravalvular leak with stent distortion. Rescue balloon valvuloplasty was performed through the right femoral artery, and resulted in the resolution of the paravalvular leak. This case illustrates the utility and feasibility of balloon valvuloplasty in trouble-shooting sutureless aortic valve stent distortion, thus avoiding a repeat aortic cross-clamp and valve replacement.


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