Sutureless Aortic Bioprosthesis Research Articles

Hypo-Attenuated Leaflet Thickening and Reduced Leaflet Motion in Sutureless Bioprosthetic Aortic Valves.

BackgroundThe prevalence of hypo‐attenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) is unknown in surgically implanted bioprostheses because systematic investigation of HALT and/or RLM is limited to a few catheter‐based valves. The aim of this study was to investigate the prevalence of HALT and RLM by cardiac computed tomography in patients who underwent surgical aortic valve replacement and received a Perceval sutureless aortic valve bioprosthesis.Methods and ResultsThis was a single‐center prospective observational study that included 47 patients (83.5% of the total number of implantations) who underwent surgical aortic valve replacement with implantation of the Perceval sutureless bioprosthesis (LivaNova PLC, London, UK) at Karolinska University Hospital in Stockholm, Sweden from 2012 to 2016 and were studied by cardiac computed tomography. Cardiac computed tomography was performed at a median of 491 days (range 36–1247 days) postoperatively. HALT was found in 18 (38%) patients and RLM in 13 (28%) patients. All patients with RLM had HALT. Among patients with HALT, 5 out of 18 patients (28%) were treated with anticoagulation (warfarin or any novel oral anticoagulant) at the time of cardiac computed tomography. Among patients with RLM, 3 out of 13 patients (23%) were treated with anticoagulation.Conclusions HALT and RLM were prevalent in the surgically implanted Perceval sutureless aortic valve bioprosthesis. Both HALT and RLM were found in patients with ongoing anticoagulation treatment. Whether these findings are associated with adverse events needs further study.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02671474.

The Perceval Sutureless Aortic Valve: Review of Outcomes, Complications, and Future Direction.

Surgical aortic valve replacement with a stented prosthesis has been the standard of care procedure for aortic stenosis. The Perceval (LivaNova, London, United Kingdom) is a sutureless aortic valve bioprosthesis currently implanted in more than 20,000 patients. The purpose of this article was to review the literature available after 9 years of clinical experience of the Perceval aortic valve. PubMED, Embase, and the Cochrane Library databases were searched. A meta-analysis of summary statistics from individual studies was conducted. A total of 333 studies were identified and 84 studies were included. Thirty-day mortality and 5-year survival ranged from 0% to 4.9% and 71.3% to 85.5%, respectively. Compared with stented prosthesis, pooled analysis demonstrated a statistically significant reduction in aortic cross-clamp and cardiopulmonary bypass times (minutes) with Perceval (38.6 vs 63.3 and 61.4 vs 84.9, P < 0.00001, respectively). Compared with transcatheter aortic valve implantation, pooled analysis demonstrated a statistically significant reduction with Perceval in paravalvular leakage (1.26% vs 14.31%) and early mortality (2.3% vs 6.9%). Favorable hemodynamics, acceptable valve durability, and ease of implantation in minimally invasive cases were reported as benefits. A trend toward increased rates of permanent pacemaker implantation and low postoperative platelet count were identified. Special use and off-label procedures described included bicuspid aortic valves, valve-in-valve for homograft and stentless prosthesis failure, concomitant valvular procedures, porcelain aorta, and endocarditis. The Perceval valve has shown safe clinical and hemodynamic outcomes. Outcomes support its continued usage and potential expansion.

Sutureless aortic bioprosthesis.

Aortic valve replacement (AVR) is the treatment of choice for aortic valve disease, with excellent results reported in the short- and long-term follow-up. Due to the increasing number of patient comorbidities and older age, various technical alternatives have been developed such as transcatheter aortic valve implantation and, more recently, sutureless valve bioprostheses. For patients with very high surgical risk, transcatheter implantation is becoming the top therapeutic option. However, the percutaneous technique still has major disadvantages including those related to implantation without excision of the diseased native valve without direct view of the annulus, which increases the probability of developing perivalvular leaks and a high percentage of atrioventricular block. Due to the need for aggressive crimping of pericardial layers, there is uncertainty about their long-term durability. A new technique for AVR using sutureless bioprosthesis has recently been developed. The main advantages of this technique are the excellent haemodynamic performance and fast deployment under direct view, thereby avoiding the knotting of surgical stitches, which is especially advantageous in more technically demanding procedures (e.g. minimally invasive surgery, calcified aortic root and reoperations). The good clinical results of these valves have been supported by scientific evidence, making it a feasible option for patients who are candidates for AVR using biologic prosthesis, especially for those with mid-high surgical risk for standard AVR and percutaneous transcatheter valve implantation. In this article, we review the latest evidence on these new prostheses, including their advantages and possible disadvantages.

Proof of Concept of an Endoscopic Sutureless Valve Sizer.

In this paper, we present an endoscopic expandable sizer conceived to allow thoracoscopic aortic valve replacement with a sutureless prosthesis using a dynamic sizing of the aortic annulus. Ten aortic torsos were prepared using a five-trocar thoracoscopic setting. Once the aortotomy was performed and the aortic valve leaflets removed, the technical feasibility of the endoscopic sizing (introduction into the trocar, expansion into the aortic annulus, determination of the valve size, and retraction) with the device was assessed. In case of successful thoracoscopic sizing, endoscopic implantation of a sutureless valve (five LivaNova Perceval prosthesis and five Medtronic 3f Enable bioprosthesis) was performed. Before ascending aorta closure, we assessed the appropriate sealing of the bioprosthesis in the native annulus with camera visualization and a nerve hook inspection. All the 10 endoscopic sizings were technically feasible. The scheduled aortic sutureless valve implantations were successfully performed. In all cases, fitting and placement of the sutureless bioprosthesis in the flaccid heart was satisfactory, with no paraprosthetic leakage detectable by the nerve hook. The use of the endoscopic expandable sizer is technically possible. In this early-stage test in the flaccid heart, selection of the valve size was satisfactory during thoracoscopic sutureless aortic bioprosthesis implantation. Further laboratory evaluation with fluid dynamics (aortic root pressurization) will be performed before a clinical study is started.

Aortic sutureless bioprosthesis with concomitant Ferrazzi procedure, Coronary revascularization and Neo-fenestrated pericardial reconstruction: report of a case

The clinical outcome of sutureless aortic bioprosthesis in concomitant complex heart surgery is still unclear.

North American single-center experience with a sutureless aortic bioprosthesis

ObjectiveSurgical sutureless aortic valves have the potential for shorter procedural times and could benefit patients with increased risk. The Enable (Medtronic Inc, Minneapolis, Minn) valve is a bioprosthesis housed in a Nitinol cage allowing folding and deployment once implanted. We aimed to evaluate the early clinical and echocardiographic results with the Enable valve. MethodsPatients with aortic stenosis, Society of Thoracic Surgeons score greater than 5.0%, the need for combined procedures, and frailty were considered for Enable implantation. ResultsBetween August 2012 and October 2014, 63 patients underwent implantation of the Enable valve (Medtronic Inc, Minneapolis, Minn). Thirty patients underwent isolated aortic valve replacement. Combined procedures were aortic valve replacement/coronary artery bypass grafting (26), aortic valve replacement/mitral valve repair (2), aortic valve replacement/mitral valve repair/coronary artery bypass grafting (2), and aortic valve replacement/ascending aortic graft (3). Predicted Society of Thoracic Surgeons score was 8.06 ± 7.73 (0.94-41.30). Implant success was 100%. Mean crossclamp time for isolated aortic valve replacement was 44 ± 14 minutes (30-91). Thirty-day mortality was 1.6% (1/63), and late mortality was 3.2% (2/62). No mortality was valve related. Intraoperative need for revision was 6.3% (4/63). Early migration requiring reoperation occurred in 1.6% of patients (1/63). Postoperative indexed aortic valve area was 1.08 ± 0.22 cm2∕m2, and peak and mean gradients were 17 ± 7 mm Hg and 9 ± 4 mm Hg, respectively. The rate of complications was as follows: pacemaker 3.1% (2/63), transient ischemic attack 1.6% (1/63), other thromboembolic events 0%, bleeding 0%, and endocarditis 0%. Mean follow-up was 10 ± 8 months. At latest follow-up, 61 patients were in New York Heart Association class I. Moderate or severe aortic regurgitation did not develop in any patients in the follow-up period. ConclusionsThe Enable bioprosthesis is an acceptable alternative to conventional aortic valve replacement in higher-risk patients. The early hemodynamic performance seems favorable.

0316: Assessment of left ventricular mass regression after implantation of a new generation of sutureless aortic bioprosthesis

The development of left ventricular (LV) concentric hypertrophy in the natural course of aortic stenosis is known as an independent prognostic factor of morbidity and mortality. The regression of LV mass after aortic valve replacement leads to an improvement of functional capacity and long-term outcome. To assess the degree of LV mass regression at one month after implantation of Edwards INTUITY. Single arm, prospective study, from July 2012 to March 2014. Echocardiography was performed preoperatively, at discharge and at one-month follow up. Inclusion criteria: 1/ Severe symptomatic aortic stenosis 2/ tricuspid aortic valve.Endpoints:1/ In hospital mortality 2/ Evolution of LVEF, IVSd and LVPWd 3/ Evolution of LV mass index 4/ Evolution of mean gradient and iEOA 5/Incidence of periprosthetic regurgitation (PPR) 72 patients, age = 77.4±6.6, BMI = 31.2±4.2, Euroscore II= 3.4±3.4, LVEF = 63.4±10.2%, Aortic valve area = 0.5±0.2 cm2, Mean gradient = 56.7±19.3mmHg, Stroke volume = 49.9±11.6 ml/m2, full sternotomy in all, associated CABG in 23 patients (33%), Cross clamping time = 48.7±22.3. 1/ In-hospital mortality: 1.4%. 2/ Evolution of LV parameters: LVEF(%) remains stable (61.6±8.9 versus 61.8±7.5, p=0.08), IVSd(mm) and LVPWd (mm) significantly decreased ((13.5±2 vs 14.9±1.7, p<0.001) and (12.5±1.5 vs 15.3±1.4, p< 0.001)). 3/ Evolution of LV mass index: LV mass index ( mg/m2) significantly decreased at one month FU(124.4±26.7 vs 167±45.1, p<0.001) 4/ Evolution of mean gradient and iEOA: Mean gradient (mmHg): 12.3±7.10 vs 56.7±19.3, p< 0.001 iEOA(cm2/m2): 1±0.4 vs 0.5±0.2, p<0.001 5/ Incidence of PPR No moderate or severe paravalvular leakage was observed at discharge and at follow-up. Edwards’s Intuity bioprosthesis provides favorable preliminary results and is associated with significant regression of LV mass during the first month after aortic valve replacement.Midterm results should be evaluated.

Clinical performance of a sutureless aortic bioprosthesis: Five-year results of the 3f Enable long-term follow-up study

Sutureless valves are designed to facilitate surgical implantation, including less-invasive techniques in aortic valve replacement, by maintaining surgical precision of implantation compared with transcatheter techniques. Long-term clinical experience with sutureless valves is lacking. We report the 5-year follow-up results of an international, prospective, multicenter study evaluating the clinical performance and safety of the 3f Enable valve (Medtronic Inc, Minneapolis, Minn). Between March 2007 and December 2009, 141 patients (54 male; mean age, 76.1±5.7 years) undergoing aortic valve replacement with the 3f Enable valve were enrolled in 10 European sites. The mean follow-up was 2.76 years (range, 2 days to 5.1 years; total, 388.7 patient-years). Echocardiographic valvular hemodynamic and morphologic analyses were performed by an independent core laboratory. The mean systolic gradient was 10.4±4.4 mm Hg at discharge and 7.7±4.1 mm Hg at 5 years. The mean effective orifice area was 1.7±0.5 cm2 at discharge and 1.6±0.2 cm2 at 5 years. Freedom from all-cause and valve-related mortality was 87.6%±2.9% and 96.8%±1.6% at 1 year (113 patients at risk) and 77.0%±7.5% and 93.8%±4.8% at 5 years (24 patients at risk), respectively. Six patients underwent reoperation (4 because of major paravalvular leakage and 2 because of endocarditis). Freedom from reoperation was 95.4%±1.9% at 1 year and 95.4%±6.1% at 5 years. No structural valve deterioration occurred during the follow-up period. The sutureless 3f Enable valve represents a safe and effective treatment for aortic valve stenosis, providing an excellent hemodynamic profile. This study represents the longest follow-up study for a sutureless bioprosthesis. Sutureless valves may become an option for all patients with indicated biological aortic valve replacement.

Two Alternative Sutureless Strategies for Aortic Valve Replacement

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. 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). Baseline patient characteristics were similar in both groups, except for mean ± SD body surface area (P group = 2.01 ± 2.9 m, E group = 1.83 ± 3.8 m; 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). 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.

Sutureless aortic valve replacement

The sutureless aortic bioprosthesis has been recently introduced in clinical practice for aortic valve replacement (SU-AVR) and appears to provide enhanced implantability and favourable haemodynamics, particularly advisable in minimally invasive surgery, in difficult anatomical situations or elderly patients. Implants of sutureless bioprosthesis are increasingly performed, and the first meaningful findings have been released and herewith analysed. A two-centre experience in 208 patients has shown safety, ease of implantation, excellent haemodynamic performance and limited aortic cross-clamp (ACC) and cardiopulmonary (cardiopulmonary bypass, CPB) times, also in the case of associated coronary artery bypass grafting. Another multicentre experience with a third sutureless, albeit stented, valve implanted in 146 patients has been also presented with early favourable results. The sutureless aortic valve has been reported to be competitive also in relation to the transcatheter aortic valve implantation (TAVI) procedure in high-risk patients, as demonstrated by a propensity score based comparative analysis in a multicentre study, with reduced paravalvular leak rate but with increased atrial fibrillation occurrence in SU-AVR cases. Other single-centre series have been published with satisfactory results in terms of excellent haemodynamic performances or of enhanced implantability in high-risk patients or during minimally invasive procedures. Sutureless aortic valve replacement has been shown to be well tolerated, to provide excellent haemodynamic performance and to be particularly suitable in minimally invasive procedures or in patients with extensive calcified aortic root or with the need of short ACC and CPB times for marked comorbidities. Further evaluations are, however, still necessary to conclusively show the actual advantages of SU-AVR, also as an alternative to TAVI procedures in operable high-risk patients.

Delayed dislocation of a sutureless aortic bioprosthesis: the first case

Sutureless aortic bioprosthesis implantation is an alternative technique in high-risk patients undergoing aortic valve replacement with a possible reduction in the extracorporeal circuit time and reliable haemodynamic features. A 3F Enable (ATS Medical-Medtronic, Inc., Minneapolis, MN, USA) has shown very good results. We report the first upward displacement of 3F Enable three months post implantation.

Sutureless aortic bioprosthesis in severe aortic root calcification: an innovative approach

Aortic valve replacement (AVR) in patients with severe aortic root calcification is technically a very difficult procedure which requires a long cardiopulmonary bypass (CPB) time, especially in patients undergoing complex procedures such as multivalve or valve and coronary surgery. We report a case of successful AVR with an innovative approach in a patient with an extensively calcified aortic root and concomitant tricuspid valve regurgitation who underwent mitral valve replacement 20 years ago.

Delayed dislocation of a sutureless aortic bioprosthesis: The first case

Introduction: Aortic valve replacement (AVR) with mechanical or biological stented valves is the standard treatment for patients with severe, symptomatic aortic stenosis. However, high-risk patients undergoing AVR may require alternative treatment options in order to reduce the cardiopulmonary bypass time.

A Perfectly Functioning Magovern-Cromie Sutureless Prosthetic Aortic Valve 42 Years After Implantation

A 65-year–old man was admitted with recurrent pulmonary edema. At the age of 23, 42 years before his admission, he had had an aortic valve replacement with a “ball-and-cage” valve for severe aortic stenosis. He had suffered a postoperative hemorrhagic stroke with right hemiparesis but had been doing well on warfarin for 42 years. Echocardiography demonstrated a perfectly functioning prosthetic aortic valve with peak transvalvular gradient of 23 mm Hg and mean gradient of 13 mm Hg with no aortic regurgitation (Figure 1, Movie I). There was also severe rheumatic mitral valve stenosis. Coronary angiography showed insignificant coronary disease, and on fluoroscopy an unusual …