Perceval Sutureless Valve Research Articles

The Sutureless Biological Bentall Procedure: A New Technique to Create a Modular Valve-Conduit Construct.

The Perceval sutureless valve (Corcym, Saluggia, Italy) has been effectively adopted by surgeons for the treatment of degenerative aortic valve stenosis. Its simplified true sutureless implantation technique has proven useful for minimally invasive cases, but the use of Perceval as part of more complex root replacement has not previously been described. We present a novel technical modification to the manufactured biologic Bentall, called the sutureless biological Bentall. This technique allows for a true modular valve-conduit construction that will simplify future reintervention.

Clinical and hemodynamic outcomes of the Perceval sutureless aortic valve from a real-world registry.

Perceval sutureless valve has been in clinical use for >15 years. The aim of this study is to report the real-word clinical and haemodynamic performance from the SURE-aortic valve replacement international prospective registry in patients who underwent aortic valve replacement with Perceval valve. From 2011 to 2021, patients from 55 institutions received a Perceval valve. Postoperative, follow-up, and echocardiographic outcomes were analysed. A total of 1652 patients were included; mean age was 75.3 ± 7.0 years (53.9% female); mean EuroSCORE II was 4.1 ± 6.3. Minimally invasive approach was performed in 45.3% of patients; concomitant procedures were done in 35.9% of cases. Within 30 days, 0.3 and 0.7% valve-related reinterventions were reported. Transient ischaemic attack, disabling and non-disabling strokes were limited (0.4%, 0.4% and 0.7%, respectively). Pacemaker implant was required in 5.7% of patients. Intra-prosthetic regurgitation ≥2 was present in 0.2% of cases, while paravalvular leak ≥2 in only 0.1%. At a maximum follow-up of 8 years, 1.9% of cardiovascular deaths and 0.8% of valve-related reintervention occurred. Among the 10 cases of structural valve deterioration (mean 5.6 ± 1.4 years after implant; range: 2.6-7.3 years), 9 were treated with a transcatheter vale-in-valve implantation and 1 with explant. Mean pressure gradient decreased from 45.8 ± 16.5 mmHg preoperatively to 13.3 ± 5.2 mmHg at discharge and remained stable during follow-up. This experience represents the largest prospective real-world cohort of patients treated with Perceval showing that Perceval is a safe and effective alternative to conventional surgical aortic valve replacement, providing favourable clinical and haemodynamic results also at mid-term follow-up.

1-year outcomes of patients implanted with the Perceval sutureless valve: the Japanese post-marketing surveillance study

Sutureless offers an alternative to standard valves in surgical aortic valve replacement (SAVR). We sought to confirm the efficacy and safety of the Perceval sutureless valve in Japanese patients. Prospective observational study of 204 patients who underwent SAVR with Perceval at 19 sites in Japan between March and December 2019. The primary outcomes were 30-day mortality and postoperative complications; the secondary outcome was all-cause mortality at 1 year. Efficacy outcomes were changed in New York Heart Association (NYHA) class, pressure gradients, effective orifice area (EOA), EOA indexed to body surface area (EOAi) and severity of aortic regurgitation. Mean age was 77.7 years, 62.7% were female. Procedural success rate was 99.0%. The median cross-clamp and cardiopulmonary bypass times were 68.0 and 108 min. Perceval size S and M were implanted in 95 (46.6%) and in 76 (37.3%) of patients, respectively. The 30-day and late mortality rate were 0.5% and 4.4%, while the new permanent pacemaker implantation rate was 4.4%. Mean pressure gradient was 13.0 mmHg at discharge, reaching 11.0 mmHg at 1 year; while the mean EOA was 1.5 cm2 at discharge remaining stable up to 1 year. No moderate or severe leakages were present at discharge or at 1 year. NYHA class improved by ≥ 1 level in 55.1% of the patients at discharge and in 69.4% of the patients at 1 year. 1-year outcomes of SAVR with the Perceval sutureless valve in Japanese patients were favorable. This valve offers a promising alternative to conventional biological AVR in this Japanese population.

Does valve size impact hemodynamic, left ventricular mass regression, and prosthetic valve deterioration with a sutureless aortic valve?

ObjectiveTo assess the mid-term clinical outcomes, hemodynamics, left ventricular (LV) mass regression, and structural valve deterioration (SVD) in patients implanted with the Perceval aortic sutureless valve across valve sizes. MethodsData were obtained from a multicenter European trial and a US Investigational Device Exemption trial. Echocardiography data were analyzed by an echocardiography core lab. A mixed-effects regression model was used to assess relationships between hemodynamic outcomes, time from the procedure, and valve sizes. The Valve Academic Research Consortium (VARC)-3 definition for bioprosthetic valve failure was applied. ResultsA Perceval sutureless valve was implanted in 970 patients. The median patient age was 77.8 years, 57.2% were female, the median Society of Thoracic Surgeons predicated risk of mortality was 3.3% (range, 2.1%-6.2%), and 33.4% had a concomitant procedure. The median clinical follow-up was 45.7 months (range, 28.2-76.1 months). Small and medium valves were implanted more commonly in women than in men (16.9% vs 1.9% for small and 55.1% vs 19.5% for medium; P < .001). The mean aortic valve gradients decreased significantly postimplantation and remained stable across all valve sizes throughout the follow-up period. All patients were free from severe patient–prosthesis mismatch (with an effective orifice area/m2 of >0.8). Significant LV mass regression was documented regardless valve sizes, plateaued at -9.1% at 5 years. Freedom from SVD and reintervention were 95.2% and 96.3%, respectively, at 5 years and were independent of implanted valve size (P = .22). The VARC-3 stage 3 bioprosthetic valve failure rate was low, 2.8% at 5 years. ConclusionsThe Perceval valve demonstrated low and stable mean gradients, significant LV mass regression, and low SVD and reintervention rates across all valve sizes.

Sutureless aortic valves in isolated and combined procedures: Thirteen years of experience in 784 patients

ObjectiveThe aim of this study was to evaluate the outcome and experience of the Perceval sutureless valve at our institution (UZ Leuven). MethodsBetween 2007 and 2019, 784 patients underwent sutureless aortic valve replacement using the Perceval valve (isolated or combined with other procedures). We performed a retrospective analysis of the postoperative and follow-up data. ResultsMean age was 78 years with a median European System for Cardiac Operative Risk Evaluation II score of 4.2% (interquartile range, 2.6%-7.2%). Isolated aortic valve replacement accounted for 45% of cases; 30% of cases were aortic valve replacement in combination with coronary artery bypass grafting and the remaining 25% were other combined procedures. The median crossclamp times were 38 minutes in single aortic valve replacement, 70 minutes in cases with coronary artery bypass grafting, and 89 minutes in multiple valve cases. Device success was 99.1% and in-hospital mortality was 3.3%. Postoperative stroke or transient ischemic attack occurred in 1.9% of patients and 1% of patients had a new need for dialysis after surgery and median survival time was 7.0 years with a cumulative follow-up of 2797.8 patient-years. The 1-, 5-, and 10-year freedom from reintervention were 99%, 97%, and 94%, respectively. ConclusionsThese data represent the longest follow-up available, to our knowledge, for the Perceval sutureless valve. We observed favorable early outcomes, and low rates of early mortality, stroke, and other major complications. Valve durability is promising with low rates of valve degeneration and a limited need for reintervention.

Sutureless Valve in Bicuspid Aortic Stenosis: Modified Technique and Midterm Outcome.

The sutureless valve has gained popularity for degenerative aortic valve stenosis but not congenital bicuspid aortic valve (BAV) due to anatomical challenges. We reviewed our modified implant techniques for patients with BAV. From June 2015 to June 2019, 66 patients with aortic valve stenosis were treated with the Perceval sutureless valve, 20 of whom had BAV. The demographics, type of BAV (the Sievers classification), and associated pathologies, surgical outcomes, and midterm hemodynamics were recorded. The median age was 64 (range: 49-81) years and the Society of Thoracic Surgeons score was 2.186 (range: 0.407-6.384). Annular plication was performed in 9 (75%) of 12 type 0 and 3 (37.5%) of 8 type I, with implanted valve sizes of M, L, and XL in 6, 10, 4 cases, respectively. Three patients, all type 0 in the initial learning periods, required intraoperative redeployment due to malposition of the valve. The final implant was successful in all without conversion to traditional prosthesis. The median extubation time was 4 hours and the durations of intensive care unit and hospital stay were 1 and 6 days. At a median follow-up of 46 (23-72) months, there was one late mortality due to hemorrhagic stroke sequel. The last echo revealed none had more than mild paravalvular leakage and the mean transvalvular pressure gradient remained stable at 9.70 (range: 6.94-15.0) mm Hg. The sutureless valve can achieve satisfactory outcomes in BAV without paravalvular leakage and excellent hemodynamics. It may serve as the benchmark for transcatheter aortic valve implantation in this unique population.

Benefits and Pitfalls of the Perceval Sutureless Bioprosthesis.

Objective: To highlight the main target points covered by clinical studies on the Perceval sutureless valve for surgical aortic valve replacement (SAVR) and raise a point of discussion for further expansion of its use when compared with stented bioprostheses (SB) and transcatheter aortic valve replacement (TAVR).Methods: We reviewed clinical trials and retrospective studies published up to date and compared the outcomes in terms of mortality, myocardial infarction (MI) stroke, paravalvular leak (PVL), permanent pacemaker implantation (PPI), bleeding and long-term outcomes.Results: Clinical studies showed that 30-day mortality ranged from 0–4% for Perceval and 2.9–7% for TAVR. The incidence of PVL (Perceval 1.9–19.4 vs. TAVR 9–53.5%), PPI (Perceval 2–11.2 vs. TAVR 4.9–25.5%), stroke (Perceval 0 vs. TAVR 0–2.8%), MI (Perceval 0 vs. TAVR 0–3.5%), were all higher in the TAVR group. Compared to other SB, mortality ranged from 0–6.4% for Perceval and 0–5.9% for SB. The incidence of PVR (Perceval 1–19.4 vs. SB 0–1%), PPI (Perceval 2–10.7 vs. SB 1.8–8.5%), stroke (Perceval 0–3.7 vs. SB 1.8–7.3%) and MI (Perceval 0–7.8 vs. SB 0–4.3%) were comparable among the groups. In patients with a bicuspid aortic valve, mortality rate was (0–4%) and PVL incidence was (0–2.3%). However, there was a high incidence of PPI (0–20%), and stroke (0–8%). Long-term survival ranged between 96.7–98.6%.Conclusions: The Perceval bioprosthesis has proved to be a reliable prosthesis for surgical aortic valve replacement due to its implantation speed, the reduced cardiopulmonary bypass time, the reduced aortic cross-clamp time and the shorter intensive care unit and hospital length of stay.

Clinical and Hemodynamic Outcomes in 121 Patients Who Underwent Perceval Sutureless Aortic Valve Implantation - Early Results From a Single Korean Institution.

This study aimed to evaluate the early outcomes of Perceval sutureless valves in the Korean population and to introduce a modified technique of guiding suture placement during valve deployment.Methods and Results:From December 2014 to April 2019, 121 patients (mean age: 74.7±6.2 years; 53.7% female) received a Perceval sutureless aortic valve replacement. To prevent conduction system injury, the depth of guiding suture placement (1 mm below the nadir of the annulus) was modified. All patients underwent echocardiographic evaluation at discharge and 6-12 months postoperatively, with a mean follow up of 13.7±11.2 months. Concomitant surgeries, such as coronary artery bypass grafting, and other valvular surgeries, were performed in 45.5% of cases. The mean aortic cross-clamp times for isolated and minimal procedures were 32.8±7.9, and 41.2±8.0 min, respectively. The overall transvalvular mean gradients were 13.1±3.8 mmHg at discharge and 11.5±4.7 mmHg at the last follow up. After modifying the guiding suture placement, permanent pacemaker implantation risk decreased from 9.9% to 2.5%. Cardiac-related mortality was 0.8%, with no patient developing valvular or paravalvular aortic regurgitation, valve thrombosis, or endocarditis. Perceval valve implantation provided a significant cardiac-related survival benefit with excellent early hemodynamic and clinical outcomes. Further research is needed to determine whether adjusting the implantation depth, such as modification of the guiding suture technique, can reduce the risk of permanent pacemaker implantation.

A pooled analysis of pacemaker implantation after Perceval sutureless aortic valve replacement.

We performed a literature meta-analysis to estimate the rate of pacemaker implantation after Perceval sutureless aortic valve replacement. Pertinent articles were identified from the PubMed, Google Scholar, Ovid MEDLINE and Ovid EMBASE databases. Eligible studies reported the de novo incidence of postoperative pacemaker implantation after Perceval valve surgery. Among 394 articles retrieved, 26 studies including 9492 patients met the inclusion criteria. The pooled event rate for postoperative pacemaker implantation was 7% [95% confidence interval (CI) 6-9%]; however, significant heterogeneity was observed across studies. In a sub-analysis, there was no difference between the rates of pacemaker implantation calculated from multicentre and registry studies (8 studies, 6845 patients; 7%, 95% CI 5-10%) and single-centre studies (18 studies, 2647 patients; 7%, 95% CI 5-9%; P = 0.75). Implantation rates were similar in high-volume studies (16 studies, 9121 patients; 7%, 95% CI 5-8%) than in low-volume studies (10 studies, 371 patients; pooled rate: 7%, 95% CI 4-14%; P = 0.5). Postoperative pacemaker implantation rates tended to decrease over time. With a pooled event rate of 7%, postoperative pacemaker implantation remains an important limitation of Perceval sutureless valve surgery, although we observed a degree of variability across included studies. The resultant findings provide a useful estimate for physicians and patients and can serve as a benchmark for future comparative studies. CRD42020188397.

Modified Implant Technique of Perceval Sutureless Valve in Congenital Type 0 Bicuspid Valve Stenosis

The Perceval sutureless valve has gained in popularity for treating degenerative aortic valve stenosis but not for congenital type 0 bicuspid aortic valve owing to anatomic challenges. We modified implant techniques following the four principles of ECHO-an acronym for elasticity, circularity, height, and orientation-to prevent paravalvular leakage and malposition.

Recovery of conduction disorders after sutureless aortic valve replacement.

Conduction disorders and the need for permanent pacemaker (PPM) implantation after surgical aortic valve replacement are well-recognized complications. However, in the case of sutureless valve prostheses, it remains unknown whether pacemaker (PM) dependency and conduction disturbances resolve over time. Our aim was to evaluate whether conduction disorders after Perceval sutureless valve implantation recover during follow-up. Patients undergoing isolated surgical aortic valve replacement or concomitant aortic valve replacement with coronary artery bypass surgery using the Perceval sutureless valve, between January 2010 and July 2018, were included. Postoperative electrocardiogram findings were analysed to determine the incidence of new-onset left bundle branch blocks (LBBBs) and the requirement for PPM implantation. During a postoperative period of 6-18 months, electrocardiogram findings during PM checks were analysed to determine PM dependency and LBBB persistence. Out of 184 patients who received a Perceval prosthesis during the study period, 39 (21.2%) patients developed new-onset LBBB and 10 patients (5.4%) received a PPM postoperatively. The occurrence of conduction disorders was not associated with valve size. Follow-up was completed in 176 (95.7%) patients. In patients with a new-onset LBBB, 35.9% recovered during follow-up (P = 0.001). Seven out of 10 (70%) patients remained PM dependent. After Perceval aortic valve implantation, new-onset LBBB recovers in more than one-third of patients during follow-up. In patients who needed a postoperative PPM, the majority remained PM dependent.

Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study

ObjectiveThe objective of this study was to report midterm clinical outcomes with a self-expandable sutureless aortic valve. MethodsBetween 2010 and 2013, 658 patients at 25 European institutions received the Perceval sutureless valve (LivaNova Plc, London, United Kingdom). Mean follow-up was 3.8 years; late cumulative follow-up was 2325.2 patient-years. ResultsThe mean age of the population was 78.3 ± 5.6 years and 40.0% (n = 263) were 80 years of age or older; mean Society of Thoracic Surgeons-Predicted Risk of Mortality score was 7.2 ± 7.4. Concomitant procedures were performed in 31.5% (n = 207) of patients. Overall duration of cardiopulmonary bypass time was 64.8 ± 25.2 minutes and aortic cross-clamping time was 40.7 ± 18.1 minutes. Thirty-day all-cause mortality was 3.7% (23 patients), with an observed:expected ratio of 0.51. Overall survival was 91.6% at 1 year, 88.5% at 2 years, and 72.7% at 5 years. Peak and mean gradients remained stable during follow-up, and were 17.8 ± 11.3 mm Hg and 9.0 ± 6.3 mm Hg, respectively, at 5 years. Preoperatively, 33.4% of those who received the Perceval valve (n = 210) were in New York Heart Association functional class I or II versus 93.1% (n = 242) at 5 years. ConclusionsThis series, representing, to our knowledge, the longest follow-up with sutureless technology in a prospective, multicenter study, shows that aortic replacement using sutureless valves is associated with low mortality and morbidity and good hemodynamic performance.

Perceval Sutureless Valve Associated Thrombocytopaenia: What is the Clinical Significance?

The Perceval tissue sutureless valve (PV) is a common biological prosthesis used for aortic valve replacement (AVR). Studies have identified an association with post-operative thrombocytopaenia. This study will examine a single surgeon’s early experience with this valve by comparing it to the Edwards Lifesciences tissue aortic valve (EV).

Anatomical circumstances and aortic cross-clamp time in minimally invasive aortic valve replacement.

Prolonged operative times, potentially leading to increased morbidity, are a possible drawback of minimally invasive aortic valve replacement. The aim of this study was to assess the impact of anatomical circumstances in the chest on aortic cross-clamp time. This retrospective study included 68 patients who underwent minimally invasive aortic valve replacement with the Perceval sutureless valve via right-anterior thoracotomy or with ministernotomy. Anatomical variables were measured during preoperative computer tomography scans. Aortic cross-clamp time was shorter in those having ministernotomy than in the right-anterior thoracotomy group (41.1 vs 52.3 min; P < 0.001). Cardiopulmonary bypass (CPB) time was not significantly different between groups (P = 0.09). A multivariable linear-regression model (P = 0.018) showed the aortic dextroposition variable to be a significant predictor of the aortic cross-clamp method and CPB times (P = 0.005 and P = 0.003) independent of other anatomical variables in the right thoracotomy group (10 mm deviation from optimal position prolonged the times for 240 and 600 s). For the whole cohort, a correlation between aortic valve dimensions and operative times was found (P = 0.046, P = 0.009). A linear-regression model (P = 0.046) predicted 90 s longer aortic cross-clamp time and 231 s longer CPB time for every 1 mm smaller aortic valve diameter. The anatomical variables are associated with the operative times in minimally invasive aortic valve replacement with sutureless valves. Considering this association, preplanning the procedure is recommended.

Perceval Sutureless Aortic Valve Implantation: Midterm Outcomes

Because our center participated in the first-in-human trial with Perceval (LivaNova, Sallugia, Italy) in 2007, this series represents the longest available clinical follow-up (11 years) with sutureless technology in aortic valve replacement. We collected all clinical and echocardiographic follow-up in 468 consecutive patients who received Perceval at our institution between 2007 and 2017. In 57% of cases, surgery was combined with coronary artery bypass grafting (39%), mitral valve surgery (17%), or other procedures (13%). Mean age was 79 years, mean EuroSCORE II was 5.1 ± 5.5 (range, 0.8-67) and mean Society of Thoracic Surgeons score was 5.8 ± 5.5. Mean cross-clamp times for isolated and combined procedures were 39 and 79 minutes, respectively. Observed all-cause 30-day mortality was 3.2%, with an early stroke rate of 1.8%. Pacemaker implantation rate was 7.9% overall, but only 3.9% in patients without preexisting conduction or rhythm disorders. All-cause mortality at 1 and 2 years was 8.8% ± 1.3% and 13.2% ± 1.6%, respectively. At the latest echocardiographic follow-up (mean, 3 years; range, 1-11 years), peak and mean gradients were 23 ± 10 mm Hg and 13 ± 6 mm Hg, respectively. During follow-up, we explanted 5 valves for endocarditis, and none for structural valve degeneration. After more than 11 years of continued clinical use of the Perceval sutureless valve, we observe low mortality and stroke rates, with good hemodynamic behavior of the valve. None of our patients was reoperated for structural valve degeneration. Because of the key benefits of this rapid-deployment valve, it has an added value in surgical aortic valve replacement.

Oversizing Increases Pacemaker Implantation Rate After Sutureless Minimally Invasive Aortic Valve Replacement.

Cardiac conduction system disturbances potentially leading to permanent pacemaker implantation are significant postoperative complications after aortic valve replacement. The aim of this study was to assess the impact of sutureless prosthetic valve oversizing on permanent pacemaker implantation rate. This multicenter retrospective study included 306 patients who underwent minimally invasive aortic valve replacement with the Perceval sutureless valve. Oversizing was determined by the implanted valve size indexed to body surface area. Data were analyzed with a multivariable logistic regression model. This study confirmed excellent postoperative results for minimally invasive aortic valve replacement with right anterior minithoracotomy approach and rapid deployment sutureless valves. Mortality rate was 1%. Eighteen (5.9%) patients received a new permanent pacemaker. Multivariable logistic regression model (P = 0.05) found oversizing as significant risk factor (P = 0.017) for permanent postoperative pacemaker implantation independent of patient age. There was a significant negative correlation between the indexed implanted valve size and the mean and peak postoperative transvalvular gradients (P < 0.001). Oversizing of sutureless prosthetic aortic valves is a risk factor for postoperative permanent pacemaker implantation. Proper sizing of Perceval is important to avoid complications and ensure optimal valve performance.

The Perceval Sutureless Valve in Patients with Failing Aortic Root Surgery: A Series of Eleven Perceval in Root Implantations

The Perceval Sutureless Valve in Patients with Failing Aortic Root Surgery: A Series of Eleven Perceval in Root Implantations

Hemodynamic Outcome at 5y of the Perceval Sutureless Valve: Results from an International Prospective Trial

Objective: To report the 5-year hemodynamic and clinical outcomes in intermediate risk patients implanted with the Perceval sutureless aortic valve.Methods: During 2010-2013, 658 patients were enro...

Cardiac Computed Tomography-Guided Sizing of Sutureless Aortic Valves

Objective: Surgical aortic valve replacement (SAVR) increasingly competes with transcatheter valve replacement (TAVR). The Perceval sutureless valve has become popular especially for minimally-inva...

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

BackgroundAortic 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 ResultsA 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.ConclusionsThe Perceval bioprosthesis improves the postoperative course compared with conventional bioprostheses and is an option for high‐risk patients.