Theodor Fischlein

Minimally invasive aortic valve replacement with Perceval S sutureless valve: early outcomes and one-year survival from two European centers.

OBJECTIVE The aim of our study was to evaluate the early outcomes and 1-year survival of patients undergoing minimally invasive aortic valve replacement with the Perceval S sutureless valve for severe aortic stenosis. METHODS From March 2010 to March 2013, 281 high-risk patients underwent minimally invasive aortic valve replacement with the Perceval S sutureless valve through either right anterior minithoracotomy (n = 164) or upper ministernotomy (n = 117) at 2 cardiac centers. RESULTS The overall in-hospital mortality was 0.7% (2 patients). The overall median cardiopulmonary bypass and crossclamp time was 81 minutes (interquartile range, 68-98) and 48 minutes (interquartile range, 37-60), respectively. Postoperative stroke occurred in 5 patients (1.8%). The incidence of paravalvular leak greater than 1 of 4 and atrioventricular block requiring pacemaker implantation was 1.8% (5 patients) and 4.2% (12 patients), respectively. No migration occurred, and the mean postoperative gradient was 13 ± 4 mm Hg. At a median follow-up of 8 months (interquartile range, 4-14), the overall survival was 90%. CONCLUSIONS Minimally invasive aortic valve replacement with the Perceval S sutureless valve in high-risk patients is a safe and reproducible procedure associated with excellent hemodynamic results, postoperative outcomes, and 1-year survival.

Sutureless aortic valve replacement: a systematic review and meta-analysis.

BACKGROUND Sutureless aortic valve replacement (SU-AVR) has emerged as an innovative alternative for treatment of aortic stenosis. By avoiding the placement of sutures, this approach aims to reduce cross-clamp and cardiopulmonary bypass (CPB) duration and thereby improve surgical outcomes and facilitate a minimally invasive approach suitable for higher risk patients. The present systematic review and meta-analysis aims to assess the safety and efficacy of SU-AVR approach in the current literature. METHODS Electronic searches were performed using six databases from their inception to January 2014. Relevant studies utilizing sutureless valves for aortic valve implantation were identified. Data were extracted and analyzed according to predefined clinical endpoints. RESULTS Twelve studies were identified for inclusion of qualitative and quantitative analyses, all of which were observational reports. The minimally invasive approach was used in 40.4% of included patients, while 22.8% underwent concomitant coronary bypass surgery. Pooled cross-clamp and CPB duration for isolated AVR was 56.7 and 46.5 minutes, respectively. Pooled 30-day and 1-year mortality rates were 2.1% and 4.9%, respectively, while the incidences of strokes (1.5%), valve degenerations (0.4%) and paravalvular leaks (PVL) (3.0%) were acceptable. CONCLUSIONS The evaluation of current observational evidence suggests that sutureless aortic valve implantation is a safe procedure associated with shorter cross-clamp and CPB duration, and comparable complication rates to the conventional approach in the short-term.

The Perceval S Aortic Valve Has the Potential of Shortening Surgical Time: Does It Also Result in Improved Outcome?

BACKGROUND Sutureless aortic valve prostheses have the potential of shortening surgical time. However, whether shorter operative times may also result in improved patient outcomes remains to be established. METHODS One hundred patients underwent minimally invasive isolated aortic valve replacement. Of these, 50 patients received a Perceval (Sorin Group, Saluggia, Italy) bioprosthesis (group P) and 50 patients received a non-Perceval valve (group NP). RESULTS The group P patients were older (77.5 ± 5.3 versus 71.7 ± 10 years, p = 0.001) and at higher risk (logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE] 9.9 ± 6.5 versus 4.3 ± 1, p = 0.001) than group NP patients. One implant failure occurred in group P (p = 0.5), and conversion to full sternotomy was necessary in 1 patient from each group. Aortic cross-clamp and cardiopulmonary bypass times were 39.4% and 34% shorter in group P (both p < 0.001). Within 30 days, a total of 5 patients died (2 in group P and 3 in group NP, p = 0.5). No significant differences were observed between groups in postoperative arrhythmias and need for pacemaker implantation (p = 0.3 and p = 0.5, respectively). Despite the higher surgical risk, group P patients less frequently required blood transfusion (1.1 ± 1.1 units versus 2.3 ± 2.8 units, p = 0.007), and had a shorter intensive care unit stay (1.9 ± 0.7 versus 2.8 ± 1.9 days, p = 0.002) and a shorter intubation time (9.2 ± 3.6 hours versus 15 ± 13.8 hours, p = 0.01). Group NP patients had a mean prosthesis size significantly smaller than for group P (23 ± 2 mm versus 23.9 ± 1.1 mm, p = 0.01). The Perceval valve provided comparable hemodynamic performance to that of non-Perceval valves (mean gradient 8.4 ± 6 mm Hg versus 10 ± 4.9 mm Hg, p = 0.24). CONCLUSIONS Sutureless implantation of the Perceval valve is associated with shorter cross-clamp and cardiopulmonary bypass times, resulting in improved clinical outcome. In addition, it compares favorably with conventional valves in terms of mortality and outcome variables.

Better Short-Term Outcome by Using Sutureless Valves: A Propensity-Matched Score Analysis

BACKGROUND Sutureless aortic valve prostheses have the potential of shortening ischemic time. However, whether shorter operative times may also result in improved patient outcomes and have an effect on hospital costs remains to be established. METHODS From March 2010 to April 2013, 566 patients underwent aortic valve replacement with bioprostheses; of these, 166 received a sutureless valve, and 400 received a stented valve. Redo and associated procedures were included. A propensity-score analysis was used to create two groups (sutureless and stented) with 82 matched pairs with comparable preoperative characteristics. Hospital outcome, follow-up, and health care resource consumption were compared. RESULTS There were 3 hospital deaths in the stented group and 2 in the sutureless group (p=0.65). Aortic cross-clamp, cardiopulmonary bypass, and operation times were significantly shorter in the sutureless group (p<0.001). Patients in the sutureless group required blood transfusion less frequently (1.2±1.3 vs 2.5±3.7 units, p=0.005), with a similar need for reexploration for bleeding (2 vs 5, p=0.221). The sutureless group had a shorter intensive care unit stay (2.0±1.2 vs 2.8±1.3 days, p<0.001), hospital stay (10.9±2.7 vs 12.4±4.4 days, p=0.001) and intubation time (9.5±4.6 vs 16.6±6.4 hours, p<0.001), and a lower incidence of postoperative atrial fibrillation (p=0.015), pleura effusions (p=0.024), and respiratory insufficiency (p=0.016). Pacemaker implantation and occurrence of neurologic events were similar between groups (p>0.05). A lower rate of postoperative complications resulted in reduced resource consumption in the sutureless group for diagnostics (€2,153 vs €1,387), operating room (€5,879 vs €5,527), and hospital stay (€9,873 vs €6,584), with a total cost saving of approximately 25% (€17,905 vs €13,498). CONCLUSIONS A shorter procedural time in the sutureless group is associated with better clinical outcomes and reduced hospital costs.

Early and intermediate outcome after aortic valve replacement with a sutureless bioprosthesis: Results of a multicenter study

OBJECTIVE The aim of this study was to evaluate the outcome of aortic valve replacement with the sutureless Perceval S aortic valve bioprosthesis (Sorin Biomedica Cardio Srl, Saluggia, Italy). METHODS This is a retrospective analysis of 314 patients (mean age, 77.9 ± 5.0 years, mean European System for Cardiac Operative Risk Evaluation II, 9.0% ± 7.6%) who underwent aortic valve replacement with the Perceval S valve with (94 patients) or without (220 patients) concomitant coronary artery bypass surgery at 5 European centers. RESULTS The Perceval S valve was successfully implanted in all but 1 patient (99.7%). The mean aortic crossclamping time was 43 ± 20 minutes (isolated procedure, 39 ± 15 minutes; concomitant coronary surgery, 52 ± 26 minutes). Severe paravalvular leak occurred in 2 patients (0.6%). In-hospital mortality was 3.2% (1.4% after isolated procedure and 7.4% after concomitant coronary surgery). In-hospital mortality was 2.8% and 4.0% among patients with a European System for Cardiac Operative Risk Evaluation II less than 10% and 10% or greater, respectively (P = .558). Octogenarians had slightly higher in-hospital mortality (5.2% vs 2.0%, P = .125; after isolated procedure: 2.7% vs 0.7%, P = .223; after concomitant coronary surgery: 9.5% vs 5.8%, P = .491) compared with younger patients. Full sternotomy did not increase the in-hospital mortality risk compared with ministernotomy or minithoracotomy access (1.3% vs 1.4%, when adjusted for baseline covariates: P = .921; odds ratio, 0.886; 95% confidence interval, 0.064-12.346). One-year survival was 90.5%. Freedom from valve-related mortality, stroke, endocarditis, and reoperation was 99.0%, 98.1%, 99.2%, and 98.3%, respectively. CONCLUSIONS The sutureless Perceval S valve is associated with excellent early survival in high-risk patients, particularly among those undergoing an isolated procedure. Further studies are needed to prove the durability of this bioprosthesis.

Clinical and haemodynamic outcomes in 658 patients receiving the Perceval sutureless aortic valve: early results from a prospective European multicentre study (the Cavalier Trial)†.

OBJECTIVES The aim of the Cavalier trial was to evaluate the safety and performance of the Perceval sutureless aortic valve in patients undergoing aortic valve replacement (AVR). We report the 30-day clinical and haemodynamic outcomes from the largest study cohort with a sutureless valve. METHODS From February 2010 to September 2013, 658 consecutive patients (mean age 77.8 years; 64.4% females; mean logistic EuroSCORE 10.2%) underwent AVR in 25 European Centres. Isolated AVRs were performed in 451 (68.5%) patients with a less invasive approach in 219 (33.3%) cases. Of the total, 40.0% were octogenarians. Congenital bicuspid aortic valve was considered an exclusion criterion. RESULTS Implantation was successful in 628 patients (95.4%). In isolated AVR through sternotomy, the mean cross-clamp time and the cardiopulmonary bypass (CPB) time were 32.6 and 53.7 min, and with the less invasive approach 38.8 and 64.5 min, respectively. The 30-day overall and valve-related mortality rates were 3.7 and 0.5%, respectively. Valve explants, stroke and endocarditis occurred in 0.6, 2.1 and in 0.1% of cases, respectively. Preoperative mean and peak pressure gradients decreased from 44.8 and 73.24 mmHg to 10.24 and 19.27 mmHg at discharge, respectively. The mean effective orifice area improved from 0.72 to 1.46 cm(2). CONCLUSIONS The current 30-day results show that the Perceval valve is safe (favourable haemodynamic effect and low complication rate), and can be implanted with a fast and reproducible technique after a short learning period. Short cross-clamp and CPB times were achieved in both isolated and combined procedures. The Perceval valve represents a promising alternative to biological AVR, especially with a less invasive approach and in older patients.

Sutureless, rapid deployment valves and stented bioprosthesis in aortic valve replacement: recommendations of an International Expert Consensus Panel.

OBJECTIVES After a panel process, recommendations on the use of sutureless and rapid deployment valves in aortic valve replacement were given with special respect as an alternative to stented valves. METHODS Thirty-one international experts in both sutureless, rapid deployment valves and stented bioprostheses constituted the panel. After a thorough literature review, evidence-based recommendations were rated in a three-step modified Delphi approach by the experts. RESULTS Literature research could identify 67 clinical trials, 4 guidelines and 10 systematic reviews for detailed text analysis to obtain a total of 28 recommendations. After rating by the experts, 12 recommendations were identified and degree of consensus for each was determined. Proctoring and education are necessary for the introduction of sutureless valves on an institutional basis as well as for the individual training of surgeons. Sutureless and rapid deployment should be considered as the valve prosthesis of first choice for isolated procedures in patients with comorbidities, old age, delicate aortic wall conditions such as calcified root, porcelain aorta or prior implantation of aortic homograft and stentless valves as well as for concomitant procedures and small aortic roots to reduce cross-clamp time. Intraoperative transoesophageal echocardiography is highly recommended, and in case of right anterior thoracotomy, preoperative computer tomography is strongly recommended. Suitable annular sizes are 19-27 mm. There is a contraindication for bicuspid valves only for Type 0 and for annular abscess or destruction due to infective endocarditis. Careful but complete decalcification of the aortic root is recommended to avoid paravalvular leakage; extensive decalcification should be avoided not to create annular defects. Proximal anastomoses of concomitant coronary artery bypass grafting should be placed during a single aortic cross-clamp period or alternatively with careful side clamping. Available evidence suggests that the use of sutureless and rapid deployment valve is associated with (can translate into) reduced early complications such as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions and renal replacement therapy, respectively, and may result in reduced intensive care unit and hospital stay in comparison with traditional valves. CONCLUSION The international experts recommend various benefits of sutureless and rapid deployment technology, which may represent a helpful tool in aortic valve replacement for patients requiring a biological valve. However, further evidence will be needed to reaffirm the benefit of sutureless and rapid deployment valves.

Sutureless aortic valve replacement with Perceval bioprosthesis: are there predicting factors for postoperative pacemaker implantation?

OBJECTIVES Aortic valve replacement (AVR) with sutureless bioprostheses has become an alternative to conventional AVR for patients with intermediate to high operative risk. However, this technique is associated with an increased risk of postoperative conduction disorders. METHODS We analysed 258 patients who underwent AVR with the Perceval prosthesis from July 2010 to September 2014 at our centre. Electrocardiography were obtained at baseline to record preoperatively the presence of conduction disorders. Preoperative risk factors, intraoperative procedures and complications (61 variables) were compared between patients with permanent pacemaker (PPM group) and without (no-PPM group) need for postoperative PPM implantation. RESULTS One hundred and sixty-nine patients underwent isolated AVR with the Perceval bioprosthesis, 89 patients had associated surgery and 23 patients underwent redo operations. The mean age was 77.7 ± 5 years, 139 patients were female (46%) and the mean logistic EuroSCORE was 13.2 ± 11%. At baseline, 8 patients had already an implanted pacemaker. Postoperatively, 27 patients (10.5%) required new PPM implantation due to complete atrioventricular block. On univariate analysis, age (PPM vs no-PPM group: 80 ± 5 vs 77 ± 5 years, P = 0.009) and preoperative presence of right bundle branch block (RBBB) [overall n = 20 (7.8%); PPM vs no-PPM group: 9 vs 11 (33 vs 4.8%); P < 0.001] were identified as independent predictors of postoperative conduction disorders, but only pre-existing RBBB persisted on multivariate analysis (odds ratio 11.3-C-statistic 0.74, error estimate 0.064, confidence interval 0.672-0.801; P = 0.0002). Among patients undergoing sutureless AVR, the rate of PPM implantation was high. CONCLUSIONS The analysis of the data collected made it possible to identify preoperatively a subset of patients undergoing sutureless AVR at higher risk of postoperative atrioventricular block. Additional surgical precautions should be implemented to prevent the occurrence of conduction disorders after sutureless AVR.

Aortic valve replacement through full sternotomy with a stented bioprosthesis versus minimally invasive sternotomy with a sutureless bioprosthesis

OBJECTIVES The aim of this study was to analyse early postoperative outcomes and 2-year survival after aortic valve replacement (AVR) through a ministernotomy with a sutureless bioprosthesis implantation compared with a full sternotomy with implantation of a stented bioprosthesis. METHODS Patients who underwent primary isolated non-emergent AVR at six European centres were included in the study. Of these, 182 (32%) underwent a ministernotomy with a sutureless bioprosthesis (ministernotomy sutureless group) and 383 (68%) a full sternotomy with a stented bioprosthesis (full sternotomy stented group). Propensity score matching was used to reduce selection bias. RESULTS In the overall cohort, 30-day mortality was 1.6 and 2.1%, and 2-year survival was 92 and 92% in the ministernotomy sutureless group and in the full sternotomy stented group, respectively. Propensity score matching resulted in 171 pairs with similar characteristics and operative risk. Aortic cross-clamp (40 vs 65 min, P < 0.001) and cardiopulmonary bypass time (69 vs 87 min, P < 0.001) were shorter in the ministernotomy sutureless group. Patients undergoing ministernotomy received less packed red blood cells but the risk for postoperative permanent pacemaker implantation was higher. There were no differences regarding 30-day mortality or 2-year survival between the two groups. CONCLUSIONS AVR through a ministernotomy with implantation of a sutureless bioprosthesis was associated with shorter aortic cross-clamp and cardiopulmonary bypass time and less transfusion of packed red blood cells, but a higher risk for postoperative permanent pacemaker implantation compared with a full sternotomy with a stented bioprosthesis.

Perceval S aortic valve implantation in mini-invasive surgery: the simple sutureless solution

The Perceval S bioprosthesis (21 and 23 mm) was approved for clinical use in December 2010 and it is now routinely used. This bioprosthesis is suggested for the treatment of patients undergoing minimally-invasive surgery for reasons of safety and reduction in implantation time. Here we describe the use of the Perceval bioprosthesis in patients undergoing minimally invasive cardiac surgery.