Sutureless versus transcatheter aortic valves in elderly patients with aortic stenosis at intermediate risk: A multi-institutional study.

OBJECTIVE: This multi-institutional study compares the long-term outcome of elderly patients with severe aortic stenosis and an intermediate risk profile undergoing sutureless versus transcatheter aortic valve implantation. METHODS: From 2008 to 2015, 967 elderly patients (>75 years) with intermediate risk (Society of Thoracic Surgeons score 4%-8%) and isolated aortic stenosis were included in the study (sutureless valve = 481; transcatheter aortic valve implantation = 486). After propensity score matching, 2 matched groups of 291 patients were obtained. Transcatheter valves implanted in patients were the CoreValve (Medtronic, Minneapolis, Minn), Edwards SAPIEN-XT (Edwards Lifesciences, Irvine, Calif), and Acurate-TA (Symetis, Lausanne, Switzerland). Primary end points included all-cause death at 30 days and 5 years. Secondary end points included early and 5-year incidence of composite adverse events (major adverse cardiovascular events: all-cause death, stroke, pacemaker implant, myocardial infarction, paravalvular leak ≥II, and reoperation). RESULTS: After matching, there were no substantial differences between groups. The 30-day mortality was significantly lower in the sutureless valve group (sutureless valve = 1.7% vs transcatheter aortic valve implantation = 5.5%; P = .024) and the rate of permanent pacemaker implantation (sutureless valve = 5.5% vs transcatheter aortic valve implantation = 10.7%, P = .032). Stroke/transient ischemic attack cumulative incidence at 5 years was 1.4% in the sutureless valve group and 5.3% in the transcatheter aortic valve implantation group (P = .010). The incidence of perivalvular leak grade II or greater was 1.3% in the sutureless valve group and 9.8% in the transcatheter aortic valve implantation group (P < .001). At 60 months follow-up, the all-cause death rate was lower in the sutureless valve group than in the transcatheter aortic valve implantation group (sutureless valve = 16.1% ± 4.1% vs transcatheter aortic valve implantation = 28.9% ± 5.3%, P = .006), and the major adverse cardiovascular event rate was lower in the sutureless valve group (sutureless valve = 23.5% ± 4.1% vs transcatheter aortic valve implantation = 39.0% ± 5.6%, P = .002). Multivariable Cox regression identified transcatheter aortic valve implantation as an independent predictor for 5-year mortality and major adverse cardiovascular events (hazard ratio, 1.86; confidence interval, 1.09-3.18; P = .022) (hazard ratio, 1.73; confidence interval, 1.13-2.73; P = .010). CONCLUSIONS: Sutureless valves improved the outcomes of aortic stenosis in elderly patients with an intermediate risk profile when compared with transcatheter aortic valve implantation. The use of transcatheter aortic valve implantation in this subset population should be evaluated in further controlled randomized trials with sutureless valve use in a comparative cohort.

A Modified Approach with Caval Transection for Supracardiac Total Anomalous Pulmonary Venous Connection: Comparison Between Conventional and Sutureless Surgery in 173 Patients.

The efficacy of primary sutureless repair for supracardiac total anomalous pulmonary venous connection (TAPVC) needs to be confirmed. This study aimed to compare the long-term outcomes between the conventional surgery and the sutureless technique with a modified approach in superior TAPVC. Between January 2008 and December 2018, 173 patients with supracardiac TAPVC underwent surgery either with the conventional procedure (n = 130) or the sutureless repair (n = 43). Multivariate analysis and competing-risk analysis were used to identify risk factors for early death and postoperative pulmonary venous obstruction (PVO), respectively. Among 173 patients who underwent repair of supracardiac TAPVC, 46 (28%) had preoperative PVO, and 22 (12.7%) had postoperative PVO. The sutureless group had a lower postoperative PVO rate compared with the conventional group (p = 0.027). The risk factors for death were age ≤ 28 days [odds ratio (OR), 11.56; 95% confidence interval (CI) 1.33-100.47, p = 0.015], weight ≤ 3 kg (OR 9.57; 95% CI 1.58-58.09, p = 0.009), emergency operation (OR 19.24; 95% CI 3.18-116.35, p = 0.002), cardiopulmonary bypass time (OR 2.16; 95% CI 1.36-3.43, p = 0.003), cross-clamp time (OR 1.73; 95% CI 1.20-2.50, p = 0.022), and duration of ventilation (OR 1.11; 95% CI 1.02-1.21, p = 0.027). Age ≤ 28 days [Hazard Ratio (HR) 1.92; 95% CI 1.92-11.02, p < 0.001] and preoperative PVO (HR 41.70; 95% CI 8.15-213.5, p < 0.001) were associated with postoperative PVO. The sutureless repair is a reliable technique for supracardiac TAPVC. Age ≤ 28 days is associated with 30-day mortality and postoperative PVO.

Sutureless versus conventional bioprostheses for aortic valve replacement in severe symptomatic aortic valve stenosis.

OBJECTIVE: Sutureless aortic valves are a novel option for aortic valve replacement. We sought to demonstrate noninferiority of sutureless versus standard bioprostheses in severe symptomatic aortic stenosis. METHODS: The Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016 to September 2018) to aortic valve replacement with a sutureless or stented valve using conventional or minimally invasive approach. Primary outcome was freedom from major adverse cerebral and cardiovascular events (composite of all-cause death, myocardial infarction, stroke, or valve reintervention) at 1 year. RESULTS: At 47 centers (12 countries), 910 patients were randomized to sutureless (n = 453) or conventional stented (n = 457) valves; mean ages were 75.4 ± 5.6 and 75.0 ± 6.1 years, and 50.1% and 44.9% were female, respectively. Mean ± standard deviation Society of Thoracic Surgeons scores were 2.4 ± 1.7 and 2.1 ± 1.3, and a ministernotomy approach was used in 50.4% and 47.3%, respectively. Concomitant procedures were performed with similar rates in both groups. Noninferiority was demonstrated for major adverse cerebral and cardiovascular events at 1 year, whereas aortic valve hemodynamics improved equally in both groups. Use of sutureless valves significantly reduced surgical times (mean extracorporeal circulation times: 71.0 ± 34.1 minutes vs 87.8 ± 33.9 minutes; mean crossclamp times: 48.5 ± 24.7 vs 65.2 ± 23.6; both P < .0001), but resulted in a higher rate of pacemaker implantation (11.1% vs 3.6% at 1 year). Incidences of perivalvular and central leak were similar. CONCLUSIONS: Sutureless valves were noninferior to stented valves with respect to major adverse cerebral and cardiovascular events at 1 year in patients undergoing aortic valve replacement (alone or with coronary artery bypass grafting). This suggests that sutureless valves should be considered as part of a comprehensive valve program.

Hemodynamic Comparison of Sutureless and Rapid-Deployment Valves with Conventional Bioprostheses.

BACKGROUND: Sutureless and rapid-deployment bioprostheses (RPDs) are advantageous due to shorter aortic cross-clamp times (ACCs); however, few studies have investigated hemodynamic outcomes in comparison to conventional bioprostheses (CBs). METHODS: All patients receiving the Perceval (LivaNova, London, United Kingdom) and Intuity (Edwards Lifesciences, Irvine, California, United States) valves from February 2016 to December 2017 were included (n = 61). For controls, patients who underwent aortic valve replacement using CB from 2015 to 2018 (n = 743) were propensity-matched (n = 108). Primary end points were mean gradient at discharge, true internal diameter (ID) after implantation, and paravalvular leakage. Secondary end points were ACCs, cardiopulmonary bypass times (CPBTs), mortality, and pacemaker implantation. RESULTS: Age was 73.2 years (standard deviation [SD]: 7.6) in the RPD group and 72.9 years (SD: 7.3) in the CB group (p = 0.827). Median logistic EuroSCORE II was 3.4% (Q1: 2; IQ3: 5.3) and 3% (Q1: 1.9; IQ3: 5.6; p = 0.599). While ACCs and CPBT were shorter in RPDs (97 [SD: 31.4] vs. 125.4 minutes [SD: 62.1], p = 0.003; and 76.1 [SD: 25.7] vs. 89.7 minutes [SD: 34.3], p = 0.022), procedural times were similar (p = 0.257). True ID was 21.97 mm (SD: 1.79) in RPDs and 20.15 mm (SD: 1.70) in CB (p < 0.001).RPDs and CB resulted in comparable mean gradients (12.8 mm Hg [SD: 6.4] vs. 13.8 mm Hg [SD: 5.6]; p = 0.387) and rate of paravalvular regurgitation. There were no differences in the rates of pacemaker implantation and mortality.In a subanalysis of RPDs, mean gradient was 15.48 mm Hg (SD: 7.51) in Perceval (n = 21) and 10.79 mm Hg (SD: 4.78) in Intuity (n = 33; p = 0.010). CONCLUSIONS: RPDs provided comparable hemodynamic performance, although implanted valves were larger in true ID. Whether this provides superior hemodynamic performance during exercise and longer durability needs further investigation. Among RPDs, the Intuity valve provided lower mean gradients at rest than Perceval valve.

Outcome of a Modified Perceval Implantation Technique.

BACKGROUND: In our institution, we developed a modification of the standard implantation technique of the Perceval sutureless aortic prosthesis (LivaNova, London, United Kingdom) that involves the usage of snuggers for the guiding sutures during valve deployment. The technique has been described elsewhere. In this article, we present the results of our initial case series comprising 128 consecutive patients. METHODS: From September 2016 to June 2018, 128 patients received a sutureless Perceval prosthesis (mean age 72.2 ± 8.5 years, 66 males). The data of the patients were prospectively collected in our general database and retrospectively analyzed using the SPSS software version 25 (IBM SPSS Inc., Chicago, Illinois, United States). Primary end points were primary implantation success and 30-day mortality. All patients underwent transthoracic echocardiography on discharge. RESULTS: Our cohort consisted of real-world scenario patients with infective endocarditis, bicuspid aortic valves and one patient with left ventricular assist device. However, we had 100% primary implantation success with no need for valve explantation or paravalvular leaks. All-cause 30-day mortality was 2.3% (3 patients) with no cardiac deaths. Two patients (1.6%) had a permanent neurological deficit, three patients (2.3%) had new-onset renal dialysis, and four patients (3.1%) needed a permanent pacemaker postoperatively. CONCLUSION: To our knowledge, this is the first case series to report on a modified implantation technique of the Perceval prosthesis. The Perceval valve prosthesis produces excellent outcome in most pathologies, so that current contraindications should be revised.

Aortic Stenosis and Small Aortic Annulus.

The presence of a small aortic annulus poses a considerable challenge in the management of patients with severe aortic stenosis, especially in elderly women, where it is a very frequent finding. The optimal approach for treating these patients remains controversial, and several surgical strategies such as aortic root enlargement, supra-annular stented prosthetic valves, stentless bioprosthesis, and sutureless bioprostheses have been proposed to improve valve hemodynamics and clinical outcomes. More recently, transcatheter aortic valve replacement has emerged as a valid alternative for the treatment of aortic stenosis and excellent valve hemodynamic results have been observed among patients with a small aortic annulus. The purpose of this review is to provide an overview of the current definition, prevalence, and clinical impact of small aortic annulus in patients with aortic stenosis, and evaluate the different therapeutic strategies currently available to improve valve hemodynamics and outcomes in this population.

Sutureless repair for postinfarction left ventricular free wall rupture.

OBJECTIVE: Left ventricular free wall rupture is a catastrophic complication of acute myocardial infarction. Sutureless repair has been reported to be an effective surgical procedure for left ventricular free wall rupture. However, the outcomes of sutureless repair remain unclear. METHODS: Between January 2001 and December 2016, 42 patients were treated for left ventricular free wall rupture at Jichi Medical University. Of them, 35 consecutive patients undergoing sutureless repair using the TachoComb (CSL Behring, Tokyo, Japan) or TachoSil (Nycomed, Zurich, Switzerland) patches were included in this study. No patient required cardiopulmonary bypass. The oozing type of left ventricular free wall rupture was observed in 33 patients (94%), and the blow-out type was observed in 2 patients (6%). The rupture sites were the anterior wall in 16 patients (46%), the posterior-lateral wall in 11 patients (31%), and the inferior wall in 8 patients (23%). RESULTS: The in-hospital mortality rate was 17% (6 patients). Re-rupture after sutureless repair occurred in 17% (6 patients). Of them, 4 cases (67%) of re-rupture occurred within 24 hours after surgery. The 2 patients with blow-out type left ventricular free wall rupture experienced re-rupture. Three patients required mitral valve surgery after sutureless repair during the admission. The overall survivals at 1, 5, and 10 years were 71.4%, 68.6%, and 62.9%, respectively. Multivariable analysis revealed that re-rupture was an independent predictor for decreased survival (hazard ratio, 58.6; 95% confidence interval, 4.9-701.6; P = .001). Postoperative pseudoaneurysm formation was not detected during the follow-up. CONCLUSIONS: Sutureless repair using TachoComb/TachoSil patches can be a viable treatment option for left ventricular free wall rupture. Care should be taken when applying this technique in cases of the blow-out type left ventricular free wall rupture.

Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes.

OBJECTIVES: We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience. METHODS: From June 2013 to January 2015, 300 patients (mean age 76.7 ± 7.7 years, 54.3% men, 37.3% ≥80 years, median Society of Thoracic Surgeons Predicted Risk of Mortality 2.8%), underwent Perceval valve implantation at 18 centers across the United States. Twenty patients (6.7%) had a bicuspid aortic valve and 5 (1.7%) patients had previous aortic valve replacement. A minimally invasive approach was used in 80 (26.7%) and concomitant procedures were performed in 113 (37.8%) patients. RESULTS: Two hundred eighty-nine patients (96.3%) were successfully implanted. Operative mortality (≤30 days) was 1.3% (n = 4) (observed to expected ratio of 0.40). One-year results included all-cause mortality in 5.2% (n = 15), stroke in 1% (n = 3), and endocarditis in 1.7% (n = 5). New permanent periprocedural pacemaker rate was 10.7% (n = 30/281); 2.5% (n = 7/281) resulted from third-degree atrioventricular block. One-year valve-related reoperation was 2.1% (n = 6). At 1-year follow-up, 98% of patients were in New York Heart Association class I/II, left ventricular mass index decreased from 103.5 ± 30.1 g/m2 at discharge to 95.8 ± 27.1 g/m2 (P = .001), and 3 (1.3%) moderate paravalvular leaks were identified. Health-related quality of life score increased from 62.7 ± 21.8 before surgery to 85.5 ± 17.8 at 1 year (P < .001). CONCLUSIONS: These results confirm the safety and effectiveness of the Perceval sutureless aortic valve replacement in study patients with lower mortality than expected from a risk prediction model. Persistent hemodynamic benefit and improvement in quality of life at 1 year support the importance of this device in the management of aortic valve disease.

A Systemic Review and Meta-Analysis of Sutureless Aortic Valve Replacement Versus Transcatheter Aortic Valve Implantation.

BACKGROUND: Sutureless aortic valve replacement (SU-AVR) and transcatheter aortic valve implantation (TAVI) are increasingly adopted methods to treat high-risk patients with severe aortic valve stenosis. We conducted a systematic review and meta-analysis to compare the clinical outcomes between these two recent methods to treat aortic valve disease. METHODS: We systematically searched multiple databases (January 2000 to October 2016) to identify original studies comparing clinical outcome between SU-AVR and TAVI. End points studied were early mortality, development of paravalvular leak, early stroke, bleeding events, and the need for pacemaker insertion. A random-effect inverse-variance weighted analysis was performed. Event rates were compared as odds ratio (OR) and 95% confidence interval (CI). RESULTS: The meta-analysis included seven observational studies comprising 617 SU-AVR and 621 TAVI patients. Early mortality was 2.5% and 5% in the SU-AVR and TAVI cohorts, respectively (OR, 0.52; 95% CI, 0.30 to 0.90; p = 0.02; I2 = 2%). Postprocedural significant paravalvular leak was much lower after SU-AVR (OR, 0.18l; 95% CI, 0.11 to 0.30; p < 0.0001). Postprocedural stroke (OR, 0.71; 95% CI, 0.24 to 2.08; p = 0.53) and the need for pacemaker insertion (OR, 0.884; 95% CI, 0.364 to 2.18; p = 0.7) were comparable between the two cohorts. CONCLUSIONS: Our meta-analysis of observational studies demonstrates that early mortality is lower after SU-AVR than after TAVI in selected patients. The rates of stroke and pacemaker implant are comparable between procedures; however, the incidence of paravalvular leak is higher after TAVI.

Outcomes and prognostic factors for postsurgical pulmonary vein stenosis in the current era.

BACKGROUND: The optimal management and prognostic factors of postsurgical pulmonary vein stenosis remain controversial. We sought to determine current postsurgical pulmonary vein stenosis outcomes and prognostic factors in a multicentric study in the current era. METHODS: Seventy-five patients with postsurgical pulmonary vein stenosis who underwent 103 procedures in 14 European/North American centers (2000-2012) were included retrospectively. A specific pulmonary vein stenosis severity score was developed on the basis of the assessment of each pulmonary vein. End points were death, pulmonary vein reintervention, and restenosis. A univariate and multivariate risk analysis was performed. RESULTS: Some 76% of postsurgical pulmonary vein stenosis occurred after repair of a total anomalous pulmonary venous return. Sutureless repair was used in 42 of 103 procedures (41%), patch veinoplasty was used in 28 procedures (27%), and endarterectomy was used in 16 procedures (16%). Overall pulmonary vein restenosis, reintervention, and mortality occurred in 56% (n = 58/103), 49% (n = 50/103), and 27% (n = 20/75), respectively. Sutureless repair was associated with less restenosis (40% vs 67%; P = .007) and less reintervention (31% vs 61%; P = .003). Mortality after sutureless repair (20%; 7/35) tends to be lower than after nonsutureless repair (33%; 13/40) (P = .22). A high postoperative residual pulmonary vein stenosis score at the time of hospital discharge was an independent risk factor for restenosis (hazard ratio [HR], 1.55; P < 10-4), reintervention (HR, 1.33; P < 10-4), and mortality (HR, 1.37; P < 10-4). The sutureless technique was an independent protective factor against restenosis (HR, 0.27; P = .006). CONCLUSIONS: Postsurgical pulmonary vein stenosis still has a guarded prognosis in the current era. The sutureless technique is an independent protective factor against restenosis. The severity of the residual disease evaluated by a new severity score is an independent risk factor for poor outcomes regardless of surgical technique.

Sutureless Perceval Aortic Valve Versus Conventional Stented Bioprostheses: Meta-Analysis of Postoperative and Midterm Results in Isolated Aortic Valve Replacement.

BACKGROUND: Aortic stenosis is the most common valvular disease and has a dismal prognosis without surgical treatment. The aim of this meta-analysis was to quantitatively assess the comparative effectiveness of the Perceval (LivaNova) valve versus conventional aortic bioprostheses. METHODS AND RESULTS: A total of 6 comparative studies were identified, including 639 and 760 patients who underwent, respectively, aortic valve replacement with the Perceval sutureless valve (P group) and with a conventional bioprosthesis (C group). Aortic cross-clamping and cardiopulmonary bypass duration were significantly lower in the P group. No difference in postoperative mortality was shown for the P and C groups (2.8% versus 2.7%, respectively; odds ratio [OR]: 0.99 [95% confidence interval (CI), 0.52-1.88]; P=0.98). Incidence of postoperative renal failure was lower in the P group compared with the C group (2.7% versus 5.5%; OR: 0.45 [95% CI, 0.25-0.80]; P=0.007). Incidence of stroke (2.3% versus 1.7%; OR: 1.34 [95% CI, 0.56-3.21]; P=0.51) and paravalvular leak (3.1% versus 1.6%; OR: 2.52 [95% CI, 0.60-1.06]; P=0.21) was similar, whereas P group patients received fewer blood transfusions than C group patients (1.16±1.2 versus 2.13±2.2; mean difference: 0.99 [95% CI, -1.22 to -0.75]; P=0.001). The incidence of pacemaker implantation was higher in the P than the C group (7.9% versus 3.1%; OR: 2.45 [95% CI, 1.44-4.17]; P=0.001), whereas hemodynamic Perceval performance was better (transvalvular gradient 23.42±1.73 versus 22.8±1.86; mean difference: 0.90 [95% CI, 0.62-1.18]; P=0.001), even during follow-up (10.98±5.7 versus 13.06±6.2; mean difference: -2.08 [95% CI, -3.96 to -0.21]; P=0.030). We found no difference in 1-year mortality. CONCLUSIONS: The Perceval bioprosthesis improves the postoperative course compared with conventional bioprostheses and is an option for high-risk patients.

Meta-analysis of sutureless technology versus standard aortic valve replacement and transcatheter aortic valve replacement.

OBJECTIVES: Aortic valve replacement (AVR) using sutureless technology is a feasible alternative in surgical patients. Comparative evidence against established strategies such as conventional AVR and transcatheter AVR is lacking, limiting the assessment of safety and efficacy. METHODS: Medline search for available evidence was undertaken. The outcomes analysed were 30-day mortality, risk for stroke, myocardial infarction, renal failure, paravalvular leak and need for permanent pacemaker. Odds ratios were pooled using fixed- and random-effect models. A trial sequential analysis was undertaken to assess the statistical reliability of cumulative evidence. RESULTS: Twelve studies of moderate methodological quality were included. Sutureless AVR was associated with at least 30% reduction in 30-day mortality versus transcatheter AVR [odds ratio (95% confidence interval) 0.40 (0.25, 0.62); P < 0.001] primarily in the low- and intermediate-risk population and a similar reduction in the risk for paravalvular leak [0.13 (0.09, 0.17); P < 0.001]. There was no reduction in the risk for 30-day mortality versus conventional AVR [1.03 (0.56, 1.88); P = 0.93]. There was evidence in favour of conventional AVR with at least 50% risk reduction in pacemaker implantation against sutureless technology. There was absence of either benefit or harm vis-à-vis risk for renal injury or stroke due to lack of required information size. CONCLUSIONS: Current evidence suggests risk reduction in 30-day mortality with sutureless AVR versus transcatheter AVR but is inconclusive versus standard AVR in matched patients. Robust randomized evidence is lacking to lend support to any potential recommendation.

Sutureless versus Transfemoral Transcatheter Aortic Valve Implant: A Propensity Score Matching Study.

BACKGROUND AND AIM OF THE STUDY: Transcatheter aortic valve implantation (TAVI), especially via the transfemoral (TF) route, is increasingly performed in patients considered in the 'gray zone' between TAVI and surgery. However, the best treatment option in this patient population remains to be established. METHODS: Since 2010, a total of 923 patients underwent either TAVI (n = 538) or sutureless aortic valve replacement (AVR) (n = 385) at the authors' institutions. Among these patients, 79 treated with TF-TAVI were compared with 79 propensity score-matched patients who had undergone elective isolated AVR with the sutureless Perceval bioprosthesis. RESULTS: In-hospital mortality did not differ significantly between patients who underwent sutureless AVR or TF-TAVI (none versus three; 3.8%; p = 0.123). Similarly, postoperative complications were comparable between groups. Atrioventricular block requiring postoperative pacemaker implantation occurred in seven patients (9.2%) of the sutureless group and in eight patients (11.1%) of the TF-TAVI group (p = 0.455). The use of blood products varied between groups in terms of red blood cell transfusions (1.7 ± 2 versus 0.3 ± 0.9 units for the sutureless group versus TF-TAVI group; p <0.001). Paravalvular leakage at discharge was present in three patients (3.8%) in the sutureless group and in 26 patients (32.9%) in the TF-TAVI group (p <0.001). The mean follow up was longer for sutureless AVR (36 ± 21 versus 27 ± 20 months; p = 0.003). Survival rates were 97.5% and 84.8% in the sutureless and TF-TAVI groups, respectively (p = 0.001). CONCLUSIONS: Both, TF-TAVI and sutureless AVR are well-standardized, safe and effective procedures. TF-TAVI seems to be a valuable alternative to surgical AVR for frail patients, reducing the need for perioperative blood transfusion. In contrast, in patients with a favorable long-term survival outcome, minimally invasive AVR remains the procedure of choice as it is associated with better long-term results.

Efficacy of sutureless aortic valves in minimally invasive cardiac surgery: an evolution of the surgical technique.

BACKGROUND: Sutureless aortic valve prostheses have the potential of shortening surgical time, but if this results in improved clinical outcome remains to be determined. The aim of this study was to compare the outcome of patients undergoing conventional vs. minimally invasive AVR, with either a stented or sutureless bioprosthesis. METHODS: From 2007 to 2015, 627 patients underwent elective isolated AVR and were divided into three groups: patients who underwent sutureless-AVR via J sternotomy (group A, N.=206) and patients who underwent stented-AVR via J sternotomy (group B, N.=247) or full-sternotomy (group C, N.=174). RESULTS: Patients in group A were significantly older than groups B and C (77±5 vs. 74±7 and 70±8 years; P<0.001). Aortic cross-clamp and cardiopulmonary bypass times were shorter in group A than in groups B and C. As expected, aortic cross-clamp time was prolonged in group B as compared to groups A and C (60±18 vs. 36±10 and 54±16 min; P<0.001). After multivariate adjustment, minimally invasive AVR resulted in significantly fewer postoperative complications in terms of drainage bleeding and the need for blood transfusions (385±287 vs. 500±338 mL, P=0.006; and 1.3±2.1 vs. 1.8±2.6 IU, P=0.001, respectively). No differences in postoperative outcomes were observed among groups. CONCLUSIONS: The minimally invasive approach confers a protective effect against bleeding complications, but it is time-consuming. The use of sutureless valves is associated with significantly shorter surgical times compared with stented bioprostheses. In addition, no differences in mortality were observed among groups, and patients who received a sutureless valve, though significantly older, showed a better clinical outcome than patients who received a stented valve.

Thrombocytopenia after Aortic Valve Replacement with Perceval S Sutureless Bioprosthesis.

BACKGROUND AND AIM OF THE STUDY: Sutureless aortic bioprosthetic valves have become an alternative to conventional bioprostheses in high surgical risk cases. A significant decline in platelet count during the immediate postoperative period was observed in cases of Perceval S sutureless aortic valve implantation. The study aim was to determine how the reduction in platelet count after Perceval S prosthesis implantation compared to that after other bioprosthesis implants. METHODS: Between July 2011 and July 2014, a total of 77 isolated biological aortic valve replacements (AVRs) was performed at the authors' institution. These included 27 Perceval S prostheses (35.1%) and 50 Mitroflow prostheses (64.9%). Platelet counts and mean platelet volumes (MPVs) were determined on the day before surgery (T0) and at 24 h (T1), 48 h (T2) and 72 h (T3) after surgery. RESULTS: There were no significant differences in inhospital mortality (three Perceval S (11.1%) versus four Mitroflow 8%); p = 0.65), nor in morbidity between groups. A total of 16 patients (20.8%) had severe postoperative thrombocytopenia (<50×103/mm3). The incidence of severe thrombocytopenia was significantly higher (p = 0.046) in Perceval S patients (n = 9; 33.3%) than in Mitroflow patients (n = 7; 14%). The platelet count recovered in all patients with severe thrombocytopenia. In an adjusted-propensity multivariate logistic regression analysis, the Perceval S prosthesis was the major independent predictor of severe thrombocytopenia after AVR (OR 0.06, 95% CI: 0008-0.5, p = 0.009). CONCLUSION: Aortic bioprosthesis implantation with the Perceval S sutureless bioprosthesis appears to be associated with the occurrence of postoperative thrombocytopenia, though without any clinical implication for the patients. Prospective randomized trials are required to confirm these data.

Sutureless Aortic Valves: Combining the Best or the Worst?

Aortic valve replacement is a life saving intervention. Significant progress has been made toward reducing surgical trauma through minimally invasive surgery and transcatheter techniques. Each of these approaches has its advantages and limitations. Sutureless aortic valves have been proposed to overcome these limitations and have been in use in Europe. It is however less than clear whether these valves will prove advantageous and whether they will have a role in the future. We review the published literature for sutureless aortic valves and their performance against standard and transcatheter aortic valve replacements.

Comparison of Sutureless and Conventional Techniques to Repair Total Anomalous Pulmonary Venous Connection.

Surgical repair of total anomalous pulmonary venous connection (TAPVC) is challenging. This study aimed to compare the outcomes of the sutureless and conventional techniques for primary repair. From October 2007 to December 2013, 179 consecutive patients underwent repair of TAPVC (sutureless, n = 81; conventional, n = 98). Propensity score matching was used to submit 140 patients to stratified analysis by the presence or absence of preoperative pulmonary venous obstruction (pre-PVO). Surgeons׳ performance differences were assessed with multilevel mixture survival analysis. Freedom from death and postoperative PVO (post-PVO) were evaluated with Kaplan-Meier curves. Risk factors for death and post-PVO were explored using Cox proportional hazard model. Surgeons׳ multilevel effects did not exist in this study. Following matching, Kaplan-Meier curves showed that for patients with pre-PVO (totally 38 cases), rates of freedom from death and post-PVO at 1 year were 80.0% (59.8%-100.0%) in the sutureless group, which was significantly better than that in the conventional group (38.3% [15.2%-61.4%], P = 0.02). For patients without pre-PVO (totally 102 cases), rates of freedom from death and post-PVO at 1 year were 96.1% [95% CI: 90.8%-100.0%] and 86.7% [76.5%-96.9%] in the sutureless and conventional groups, respectively (P = 0.15). Conventional technique was a risk factor for death (hazard ratio = 4.14, 95% CI: 1.29-13.28) and post-PVO (hazard ratio = 5.56, 95% CI: 1.18-26.27) adjusting for type of TAPVC, pre-PVO, and other confounders. In conclusions, the sutureless strategy for primary repair of TAPVC is safe and effective. For patients with pre-PVO, this strategy may associate with decreased mortality and post-PVO with statistical significance.

Sutureless aortic valve replacement may improve early mortality compared with transcatheter aortic valve implantation: A meta-analysis of comparative studies.

OBJECTIVES: To determine which improves clinical outcomes more, sutureless (including rapid-deployment) aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI), we performed a meta-analysis of comparative studies. METHODS: MEDLINE and EMBASE were searched through June 2015 using Web-based search engines (PubMed and OVID). Studies considered for inclusion met the following criteria: the design was a comparative study; the study population included patients with severe aortic valve stenosis, patients were assigned to sutureless AVR versus TAVI; and main outcomes included at least early (in-hospital or 30-day) all-cause mortality. RESULTS: Of 87 potentially relevant articles screened initially, no randomized controlled trials and 7 observational comparative studies of sutureless AVR versus TAVI (enrolling a total of 945 patients) were identified and included. The first pooled analysis demonstrated a statistically significant reduction in mortality with sutureless AVR over TAVI [2.5% versus 7.3%; odds ratio (OR), 0.33; 95% confidence interval (CI), 0.16 to 0.69; p=0.003; risk difference (RD), -5.23%; 95% CI, -8.12% to -2.33%; p=0.0004]. The second pooled analyses demonstrated no statistically significant difference in bleeding complications, acute kidney injury, and conduction disturbance between sutureless AVR and TAVI. The third pooled analysis demonstrated a statistically significant reduction in paravalvular aortic regurgitation (AR) with sutureless AVR over TAVI (3.5% versus 33.2%; OR, 0.09; 95% CI, 0.05 to 0.16, p<0.00001; MD, -22.56%; 95% CI, -36.59% to -8.53%; p=0.002). CONCLUSIONS: Compared with TAVI, sutureless AVR may be associated with a reduction in early mortality and postoperative paravalvular AR.

A Meta-Analysis of Sutureless or Rapid-Deployment Aortic Valve Replacement.

Objective To summarize the safety of sutureless or rapid-deployment aortic valve replacement (AVR), we performed a systematic review and meta-analysis of single-arm studies. Methods MEDLINE and EMBASE were searched through December 2014. Studies considered for inclusion met the following criteria: the design was a single-arm study enrolling ≥50 participants; the study population consisted of patients undergoing sutureless/rapid-deployment AVR; and main outcomes included early (in-hospital or 30-day) mortality and/or overall survival. Results Of 250 potentially relevant articles screened initially, 11 eligible studies enrolling a total of 2,066 patients were identified and included. The Enable, Intuity, and Perceval bioprostheses were used in three, two, and six studies, respectively. Mean age of patients was 77.6 years, and 56.9% of patients were women. Mean logistic European System for Cardiac Operative Risk Evaluation I and II were 10.5 and 7.4%, respectively. Aortic cross-clamp times in overall patients, patients undergoing isolated AVR, those undergoing AVR with any concomitant procedures, and those undergoing AVR with coronary artery bypass grafting were 44.7, 41.9, 56.2, and 51.3 minutes, respectively. Arithmetic mean of early mortality was 2.6%, and fixed-effects combined early mortality was 3.2% (95% confidence interval, 2.5-4.2%). Arithmetic mean of 1-year survival was 89.7%, and fixed-effects combined 1-year mortality was 10.4% (9.0-12.1%). Conclusion Sutureless/rapid-deployment AVR is feasible and safe with approximate 3 and 10% of early and 1-year mortality, respectively. Large-size randomized controlled trials, however, are needed to determine whether sutureless/rapid-deployment AVR improves mortality compared with conventional AVR.

Immediate outcome after sutureless versus transcatheter aortic valve replacement.

The aim of this study was to compare the immediate outcome of patients undergoing transcatheter (TAVI) versus surgical aortic valve replacement with the sutureless Perceval bioprosthesis (SU-AVR). This is a retrospective multicenter analysis of 773 patients who underwent either TAVI (394 patients, mean age, 80.8 ± 5.5 years, mean EuroSCORE II 5.6 ± 4.9 %) or SU-AVR (379 patients, 77.4 ± 5.4 years, mean EuroSCORE II 4.0 ± 3.9 %) with or without concomitant myocardial revascularization. Data on SU-AVRs were provided by six European institutions (Belgium, Finland, Germany, Italy and Sweden) and data on TAVIs were provided by a single institution (Catania, Italy). In-hospital mortality was 2.6 % after SU-AVR and 5.3 % after TAVI (p = 0.057). TAVI was associated with a significantly high rate of mild (44.0 vs. 2.1 %) and moderate-severe paravalvular regurgitation (14.1 vs. 0.3 %, p < 0.0001) as well as the need for permanent pacemaker implantation (17.3 vs. 9.8 %, p = 0.003) compared with SU-AVR. The analysis of patients within the 25th and 75th percentiles interval of EuroSCORE II, i.e., 2.1-5.8 %, confirmed the findings of the overall series. One-to-one propensity score-matched analysis resulted in 144 pairs with similar baseline characteristics and operative risk. Among these matched pairs, in-hospital mortality (6.9 vs. 1.4 %, p = 0.035) was significantly higher after TAVI. SU-AVR with the Perceval prosthesis in intermediate-risk patients is associated with excellent immediate survival and is a valid alternative to TAVI in these patients.