Ten-year experience with sutureless Perceval bioprosthesis: single-centre analysis in 1157 implants.

AIMS: We describe long-term clinical and echocardiographic outcomes in the largest single-centre cohort of patients who underwent aortic valve replacement (AVR) with sutureless Perceval (CorCym, Italy) bioprosthesis. METHODS: Between March 2011 and March 2021, 1157 patients underwent AVR with Perceval bioprosthesis implantation. Mean age was 77 ±â€Š6 years (range: 46-89 years) and mean EuroSCORE II was 6.7 ±â€Š3.2% (range: 1.7-14.2%). Concomitant procedures were performed in 266 patients (23%). RESULTS: Thirty-day mortality was 1.38% (16/1157). Eight hundred and twenty of 891 (92%) isolated AVRs underwent minimally invasive surgery with a ministernotomy ( n  = 196) or right minithoracotomy ( n  = 624) approach. Cardiopulmonary bypass and aortic cross-clamp times were 81.1 ±â€Š24.3 and 50.6 ±â€Š11.7 min for isolated AVR and 144.5 ±â€Š34.7 and 96.4 ±â€Š21.6 min for combined procedures. At mean follow-up of 53.08 ±â€Š6.7 months (range: 1-120.5 months), survival was 96.5% and mean transvalvular pressure gradient was 13.7 ±â€Š5.8 mmHg. Left ventricular mass decreased from 152.8 to 116.1 g/m 2 ( P  < 0.001) and moderate paravalvular leakage occurred in three patients without haemolysis not requiring any treatment. Freedom from reoperation was 97.6%. Eight patients required surgical reintervention and 19 patients transcatheter valve-in-valve procedure for structural prosthesis degeneration at a mean of 5.6 years after first operation (range: 2-9 years). CONCLUSION: AVR with a Perceval bioprosthesis is associated with good clinical results and excellent haemodynamic performance in our 10-year experience. Structural degeneration rate of Perceval is comparable with other bioprosthetic aortic valves. Sutureless technology may reduce operative time especially in combined procedures and enable minimally invasive AVR.

Right anterior mini-thoracotomy and sutureless valves: the perfect marriage.

BACKGROUND: A minimally invasive approach (MIA) reduces mortality and morbidity in patients referred for aortic valve replacement (AVR). Sutureless technology facilitates a MIA. We describe our experience with the sutureless Perceval (LivaNova, Italy) aortic bioprosthesis through a right anterior mini-thoracotomy (RAMT) approach. METHODS: Between March 2011 and October 2019, 1,049 patients underwent AVR with Perceval bioprosthesis. Five hundred and three patients (48%) were operated through a RAMT approach in the second intercostal space. Considering only isolated AVR (881), 98% of patients were operated with MIA, and Perceval in RAMT approach was performed in 57% of these patients. Eight patients (1.6%) had previously undergone cardiac surgery. The prosthesis sizes implanted were: S (n=91), M (n=154), L (n=218) and XL (n=40). Concomitant procedures were mitral valve surgery (n=6), tricuspid valve repair (n=1), mitral valve repair and tricuspid valve repair (n=1) and miectomy (n=2). Mean age was 78±4 years (range, 65-89 years), 317 patients were female (63%) and EuroSCORE II was 5.9%±8.4%. RESULTS: The 30-day mortality was 0.8% (4/503). Cardiopulmonary bypass (CPB) and aortic cross-clamp times were 81.6±30.8 and 50.3±24.5 minutes respectively for stand-alone procedures. In two patients, early moderate paravalvular leakage appeared as a result of incomplete expansion of the sutureless valve due to oversizing of the bioprosthesis, requiring reoperations at two and nine postoperative days with sutured aortic bioprosthesis implantation. Permanent pacemaker implantation within the first thirty days was necessary in 26 (5.2%) patients. At the mean follow-up of 4.6 years (range, 1 month to 8.6 years), survival was 96%, freedom from reoperation was 99.2%, and mean transvalvular pressure gradient was 11.9±4.3 mmHg. CONCLUSIONS: AVR with the Perceval bioprosthesis in a RAMT approach is a safe and feasible procedure associated with low mortality and excellent hemodynamic performance. Sutureless technology facilitates a RAMT approach.

Minimally Invasive Sutureless Aortic Valve Replacement is Associated With Improved Outcomes in Patients With Left Ventricular Dysfunction.

OBJECTIVE: Patients with severe aortic stenosis and reduced left ventricular ejection fraction (LVEF) have a poor prognosis compared with patients with preserved LVEF. To evaluate the impact of sutureless Perceval (LivaNova, Italy) aortic bioprosthesis on LVEF and clinical outcomes in patients with baseline left ventricular (LV) dysfunction who underwent isolated aortic valve replacement (AVR). METHODS: Between March 2011 and August 2017, 803 patients underwent AVR with Perceval bioprosthesis implantation. Fifty-two isolated AVR had preoperative LVEF ≤45%. Mean age of these patients was 77 ± 6 years, 24 patients were female (46%), and mean EuroSCORE II was 9.4% ± 4.8%. Perceval bioprosthesis was implanted in 9 REDO operations. In 43 patients (83%), AVR was performed in minimally invasive surgery with an upper ministernotomy (n = 13) or right anterior minithoracotomy (n = 30). RESULTS: One patient died in hospital. Cardiopulmonary bypass and aortic cross-clamp times were 85.5 ± 26 minutes and 55.5 ± 19 minutes, respectively. At mean follow-up of 33 ± 20 months (range: 1 to 75 months), survival was 90%, freedom from reoperation was 100%, and mean transvalvular pressure gradient was 11 ± 5 mmHg. LVEF improved from 37% ± 7% preoperatively to 43% ± 8% at discharge (P < 0.01) and further increased to 47% ± 9% at follow-up (P = 0.06), LV mass decreased from 149.8 ± 16.9 g/m2 preoperatively to 115.3 ± 11.6 g/m2 at follow-up (P < 0.001), and moderate paravalvular leakage occurred in 1 patient without hemolysis not requiring any treatment. CONCLUSIONS: AVR with sutureless aortic bioprosthesis implantation in patients with preoperative LV dysfunction demonstrated a significant immediate and early improvement in LVEF.

Aortic Valve Replacement With Perceval Bioprosthesis: Single-Center Experience With 617 Implants.

BACKGROUND: This study describes the clinical and echocardiographic outcomes in a large single-center cohort of patients who underwent aortic valve replacement (AVR) with a sutureless Perceval (LivaNova, Milan, Italy) aortic bioprosthesis. METHODS: Between March 2011 and December 2015, 617 patients underwent AVR with a Perceval bioprosthesis. The mean age was 76 ± 7 years, 388 patients were female (63%), and the mean European System for Cardiac Operative Risk Evaluation (EuroSCORE) II was 6.2% ± 5.4%. Concomitant procedures were mitral valve surgery (n = 74), tricuspid valve repair (n = 22), coronary artery bypass grafting (n = 42), myectomy (n = 3), and ascending aorta replacement (n = 2). RESULTS: The 30-day mortality rate was 1.9% (12 of 617). A total of 475 of 516 (92%) patients who had isolated AVR underwent minimally invasive surgery with an upper ministernotomy (n = 81) or a right anterior minithoracotomy (n = 394) approach. Cardiopulmonary bypass and aortic cross-clamp times were 81.7 ± 29.1 minutes and 50.5 ± 19.8 minutes for isolated AVR and 139.7 ± 51.5 minutes and 91.5 ± 29.5 minutes for combined procedures, respectively. At mean follow-up of 16.3 months (range, 0 to 51.9 months), the survival rate was 91.3%, the rate of freedom from reoperation was 99%, and the mean transvalvular pressure gradient was 11.9 ± 5.4 mm Hg. Left ventricular ejection fraction increased from 53.6% ± 8.4% to 54.5% ± 4.8% (p = 0.40), left ventricular mass decreased from 146.5 to 112.6 g/m2 (p < 0.001), and moderate paravalvular leakage occurred in 3 patients without hemolysis who did not require any treatment. CONCLUSIONS: AVR with the Perceval bioprosthesis is associated with low mortality rates and excellent hemodynamic performance. Sutureless technology may reduce operative times, especially in combined procedures, and may make minimally invasive AVR more easily reproducible.

Right anterior minithoracotomy for aortic valve replacement: 10-year experience of a single center.

OBJECTIVE: Minimally invasive aortic valve replacement (AVR) has been associated with several better outcomes over the standard full sternotomy approach. We revised our 10-year experience with right anterior minithoracotomy (RAMT) for AVR. METHODS: Between 2004 and 2014, a total of 593 patients (310 men; median age: 73.8 years) underwent AVR via RAMT. Preoperatively, a mixed valve lesion was diagnosed in 55 (9.3%) patients; and pure aortic regurgitation in 86 (14.5%). Mean logistic EuroSCORE I (European system for cardiac operative risk evaluation) was 7.4 (median: 5.76). RESULTS: In 302 (50.9%) patients, a sutureless or rapidly implantable biological prosthesis was used; in 23 (3.9%), a mechanical prosthesis; and in the remainder, a conventional biological prosthesis. A total of 113 (19.1%) patients had a small aortic annulus (≤21 mm). Operative times averaged 80 (median: 74) minutes of crossclamping time, and 117 (107) minutes of perfusion time; these were significantly shorter with a sutureless prostheses, compared with a sutured prostheses: perfusion 99 versus 134 minutes, P < .0005; aortic crossclamping time: 64 versus 97 minutes, P < .0005. The mean (median) assisted ventilation time was 9.8 (6) hours; intensive care unit stay was 1.5 (1) days; hospital length of stay was 6.6 (6) days. Overall in-hospital mortality was 9 deaths (1.5%). At 31.5 months mean follow-up time (1531 cumulative patient-years), 94.8% survival was observed. CONCLUSIONS: Minimally invasive AVR is a safe procedure, with low perioperative morbidity, and low rates of reoperation and death at late follow-up. Excellent outcomes can be achieved with minimally invasive AVR via right anterior minithoracotomy. Sutureless prostheses facilitate minimally invasive AVR and are associated with reduced operative times.

Regression of left ventricular mass after implantation of the sutureless 3f Enable aortic bioprosthesis.

Left ventricular hypertrophy in aortic stenosis is considered a compensatory response for the maintenance of systolic function but a risk factor for cardiac morbidity and death. We investigated the degree of left ventricular mass regression after implantation of the sutureless Medtronic 3f Enable Aortic Bioprosthesis. We studied 19 patients who, from May 2010 through July 2011, underwent isolated aortic valve replacement with the 3f Enable bioprosthetic valve, with clinical and echocardiographic follow-up at 6 months. The mean age was 77.1 ± 5.1 years (range, 68-86 yr); 14 patients were women (73.7%); and the mean logistic EuroSCORE was 15.4% ± 11.8%. Echocardiography was performed preoperatively, at discharge, and at 6 months' follow-up. The left ventricular mass was calculated by means of the Devereux formula and indexed to body surface area. The left ventricular mass index decreased from 146.1 ± 47.6 g/m(2) at baseline to 118.1 ± 39.8 g/m(2) at follow-up (P=0.003). The left ventricular ejection fraction did not change significantly. The mean transaortic gradient decreased from 57.3 ± 14.2 mmHg at baseline to 12.3 ± 4.6 mmHg at discharge and 12.2 ± 5.3 mmHg at follow-up (P <0.001), and these decreases were accompanied by substantial clinical improvement. No moderate or severe paravalvular leakage was present at discharge or at follow-up. In isolated aortic stenosis, aortic valve replacement with the 3f Enable bioprosthesis results in significant regression of left ventricular mass at 6 months' follow-up. However, this regression needs to be verified by long-term echocardiographic follow-up.

Left ventricular mass regression after two alternative sutureless aortic bioprostheses.

OBJECTIVE: Left ventricular (LV) hypertrophy in aortic stenosis (AS) constitutes a risk factor for cardiac morbidity and mortality. The aim of this study was to investigate the degree of LV mass regression after aortic valve replacement (AVR) with two alternative sutureless self-expanding strategies: Perceval S (Sorin Group, Saluggia, Italy) (P) and 3f Enable (Medtronic, ATS Medical, Minneapolis, MN USA) (E) aortic bioprostheses. METHODS: Between March 2010 and December 2011, 129 patients with symptomatic AS underwent AVR with the Perceval S or 3f Enable bioprostheses in two cardiac surgery departments (Massa, Italy; Nuremberg, Germany). We analyzed 45 patients in group P and 19 in group E undergoing isolated AVR with a 6-month follow-up. The LV mass was calculated using the Devereux formula and was indexed to body surface area. RESULTS: Baseline patient characteristics showed no significant differences between the two groups. There were no in-hospital deaths. Two patients in group P died at follow-up versus zero in group E (P = 0.49). Mean LV mass index decreased from 146.6 (78) g/m at baseline to 123.3 (63) g/m at follow-up (P < 0.001) in group P and from 146.1 (47.6) g/m to 118.1 (39.8) g/m (P = 0.003) in group E, with no significant difference between the two groups (P = 0.315). This effect was accompanied by significant clinical improvement. CONCLUSIONS: In isolated AS, AVR with sutureless bioprostheses is associated with a significant regression in LV mass at 6-month follow-up. No significant differences were present between the two alternative sutureless strategies. However, regression needs an evaluation with long-term echocardiographic examinations.

Two alternative sutureless strategies for aortic valve replacement: a two-center experience.

OBJECTIVE: Important comorbid conditions in patients referred for aortic valve replacement (AVR) require less invasive strategies. We describe our initial experience with the Perceval S (Sorin Group, Saluggia, Italy) and 3f Enable (Medtronic, Minneapolis, MN USA) sutureless aortic bioprostheses. METHODS: We compared intraoperative data, postoperative clinical outcomes, and echocardiographic results from patients receiving a Perceval S (P group; n = 97) or a 3f Enable (E group; n = 32) prosthesis in two cardiac surgery departments (Nuremberg, Germany, and Massa, Italy). RESULTS: Baseline patient characteristics were similar in both groups, except for mean ± SD body surface area (P group = 2.01 ± 2.9 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). CONCLUSIONS: Aortic valve replacement with sutureless aortic bioprosthesis is feasible, also with a minimally invasive approach. The Perceval S showed lower operative times and moderate paravalvular leaks and lower mean transvalvular gradients than did the 3f Enable, related to the larger diameter of the Perceval S implanted. Both prostheses showed an excellent hemodynamic performance. This new technology needs long-term follow-up.

Sutureless aortic valve implantation through an upper v-type ministernotomy: an innovative approach in high-risk patients.

OBJECTIVE: Aortic valve replacement in minimally invasive approach has shown to improve clinical outcomes even with a prolonged cardiopulmonary bypass and aortic cross-clamp (ACC) time. Sutureless aortic valve implantation may ideally shorten operative time. We describe our initial experience with the sutureless 3f Enable (Medtronic, Inc, ATS Medical, Minneapolis, MN USA) aortic bioprosthesis implanted in minimally invasive approach in high-risk patients. METHODS: Between May 2010 and May 2011, thirteen patients with severe aortic stenosis underwent aortic valve replacement with the 3f Enable bioprosthesis through an upper V-type ministernotomy interrupted at the second intercostal space. The mean ± SD age was 77 ± 3.9 years (range, 72-83 years), 10 patients were women, and the mean ± SD logistic EuroSCORE was 15% ± 13.5%. Echocardiography was performed preoperatively, at postoperative day 1, at discharge, and at follow-up. Clinical data, adverse events, and patient outcomes were recorded retrospectively. The median follow-up time was 4 months (interquartile range, 2-10 months). RESULTS: Most of the implanted valves were 21 mm in diameter (19-25 mm). The CPB and ACC times were 100.2 ± 25.3 and 66.4 ± 18.6 minutes. At short-term follow-up, the mean ± SD pressure gradient was 14 ± 4.9 mm Hg; one patient showed trivial paravalvular leakage. No patients died during hospital stay or at follow-up. CONCLUSIONS: The 3f Enable sutureless bioprosthesis implanted in minimally invasive approach through an upper V-type ministernotomy is a feasible, safe, and reproducible procedure. Hemodynamic and clinical data are promising. This innovative approach might be considered as an alternative in high-risk patients. Reduction of CPB and ACC time is possible with increasing of experience and sutureless evolution of actual technology.

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.

Mitral and aortic valve endocarditis caused by a rare pathogen: Streptococcus constellatus.

Streptococcus constellatus endocarditis is associated with systemic embolism and frequently with a poor prognosis. We describe the first case reported in the literature of infective endocarditis by penicillin-resistant S. constellatus causing both mitral and aortic valve regurgitation, treated successfully with double-valve replacement.

Transcatheter valve in valve implantation for failed mitral and tricuspid bioprosthesis.

OBJECTIVE: We report our experience with the transapical transcatheter "Valve in valve" implantation (T-VIV) in patients with a failed mitral or tricuspid bioprosthesis; we briefly review the pertinent literature, and discuss some technical aspects of this procedure. BACKGROUND: Redo valve surgery for failure of a mitral or tricuspid bioprosthesis might become extremely challenging, both because of the patients' condition, which is frequently poor, and for the technical aspects of the operation itself, that can be very demanding. T-VIV has been widely employed with good results for the treatment of aortic bioprosthesis failure, and could represent an attractive option in this setting. METHODS: Four patients with multiple comorbidities (age: 63-83 years; logistic Euroscore: 37.2-81.5) underwent T-VIV at our institution for failure of a mitral [3] or tricuspid [1] bioprosthesis. A 26 mm Sapien valve was used in all cases. All the mitral procedures were performed via a transapical approach. The tricuspid procedure was performed via a transjugular approach. RESULTS: The first mitral procedure was complicated by the splaying of the xenograft stents and embolization of the valve. The procedure was converted to conventional surgery, and the patient died on postoperative day 1. In the subsequent procedures, the valve was positioned more atrially, and was fixed to the malfunctioning xenograft sewing ring. All subsequent procedures were successful, all patients were discharged home and were alive and well at follow-up. CONCLUSIONS: The results of T-VIV procedure in the mitral position have been suboptimal, and four of the sixteen patients reported to date died. However, all patients were extremely diseased, and some of the reported failures were related to amendable technical factors relative to the surgical access or to the valve deployment technique. With increasing experience, this procedure might become indicated as an alternative to conventional surgery in selected patients, encouraging increased use of bioprosthesis, and marking a pivotal change in the management of valvular disease.

Transmyocardial laser revascularization 12 years later.

We report the long-term follow-up of 34 patients who underwent transmyocardial laser revascularization (TMLR) from 1995 to 1999. At 12 years the actuarial survival is 24%±8%, actuarial freedom from cardiac deaths is 36%±10% and actuarial freedom from major adverse cardiac events 13%±8%. Mean angina class of nine current survivors is 2.7±0.6. Based on these results, the use of TMLR as an isolated procedure remains questionable. TMLR could probably achieve better results when employed in combination with myocardial revascularization or as a vehicle of intramyocardial growth factors.

A hanging mass in the ascending aorta diagnosed by transthoracic echocardiography in a totally asymptomatic subject.

Aortic mural thrombosis is generally associated with several diseases, including coagulopathies, aortic dissection or trauma, tumors, and complicated atherosclerotic plaques. The development of a friable mobile thrombus, especially in the ascending aorta or proximal aortic arch, is a rare event with potentially ominous consequences because of a life-threatening risk of stroke and peripheral embolization. The treatment of choice of this condition is still controversial. We report a case of an absolutely asymptomatic 57-year-old patient with a mobile, pedunculated mass attached to the posterior wall of an otherwise normal ascending aorta. The aortic mass, identified by transthoracic echocardiography, was surgically removed and demonstrated to be a thrombus, and the aortic wall specimen was microscopically normal.

Percutaneous mitral annuloplasty: an anatomic study of human coronary sinus and its relation with mitral valve annulus and coronary arteries.

BACKGROUND: To allow performance of "stand-alone" mitral annuloplasty with minimal invasiveness, percutaneous techniques consisting of delivery into the coronary sinus (CS) of devices intended to shrink the mitral valve annulus have recently been tested in animal models. These techniques exploit the anatomic proximity of the CS and mitral valve annulus in ovine or dogs. Knowledge of a detailed anatomic relationship between the CS, coronary arteries, and mitral valve annulus in humans is essential to define the safety and efficacy of percutaneous techniques in clinical practice. We sought to determine the qualitative and quantitative anatomic relationships between CS and surrounding structures in human hearts. METHODS AND RESULTS: The distance from the CS to the mitral valve annulus and the relationship between the CS and surrounding structures were studied in 61 excised cadaveric human hearts. Maximal distance from the CS to the mitral valve annulus was found to be up to 19 mm (mean, 9.7+/-3.2 mm). A diagonal or ramus branch, main circumflex artery, or its branches were located between anterior interventricular vein/CS and the mitral valve annulus in 16.4% and 63.9% of cases, respectively. CONCLUSIONS: Surgical anatomy suggests that in humans the CS is located behind the left atrial wall at a significant distance from the mitral valve annulus. Percutaneous mitral annuloplasty devices probably shrink the mitral valve annulus only by an indirect traction mediated by the left atrial wall; a theoretical risk of compressing coronary artery branches exists. Chronic studies are needed to address this problem and to determine long-term efficacy of such methods.