Freedom SOLO Stentless Aortic Valve Research Articles

Aortic valve replacement using the Freedom SOLO stentless bioprosthesis: clinical and haemodynamic performance in 625 patients at medium-term follow-up.

Our goal was to analyse the haemodynamic and clinical results after implantation of the Freedom SOLO stentless aortic valve replacement by assessing the immediate postoperative results regarding mortality, discharge echocardiographic gradients and reoperation rates and by evaluating these results in the medium term. This study was designed as a single-centre retrospective observational trial. Clinical and echocardiographic data were collected retrospectively from 625 patients undergoing an aortic valve replacement using the Freedom Solo stentless valve (LivaNova, London, UK) at the Sint-Jan Hospital, Bruges, between May 2009 and May 2017. The mean age of the patient was 76 ± 6.9 years. Early operative (30-day) mortality was 3.5% overall and 0.8% (n = 2) in patients having isolated aortic valve replacement. Early reinterventions were necessary in 3% of patients (n = 19). Permanent pacemaker implantation was performed in 3%. The mean postoperative peak gradient was 14.3 ± 8.14 mmHg, and the mean gradient was 7.5 ± 4.46 mmHg. Fourteen patients underwent explantation, 2 of which were for structural valve deterioration and 8 for endocarditis. Overall survival at 7 years was 55% [95% confidence interval (CI) 47-62]. At 7 years, freedom from reoperation overall, freedom from operation for endocarditis and freedom from operation for structural valve deterioration were 94% (95% CI 88-97), 97% (95% CI 94-99) and 98% (95% CI 90-99), respectively. The Freedom Solo stentless aortic valve has proved to be safe, with excellent clinical and haemodynamic results. Structural valve degeneration and explantation occur infrequently, illustrating good durability in the medium term.

The Freedom Solo pericardial stentless valve: Single-center experience, outcomes, and long-term durability

ObjectivesTo report our institutional experience and long-term results with the Freedom Solo bovine pericardial stentless bioprosthesis (Sorin Group, Saluggia, Italy). MethodsBetween January 2005 and November 2009, 149 patients (mean age, 73.6 ± 8.7 years; 68 [45.6%] female) underwent isolated (n = 75) or combined (n = 74) aortic valve replacement (AVR) using the Solo in our institution. Follow-up was 100% complete with an average follow-up time of 5.9 ± 2.6 years (maximum, 9.6 years) and a total of 885.3 patient years. ResultsOperative (30-day) mortality was 2.7% (1.3% for isolated AVR [n = 1] and 4.0% for combined procedures [n = 3]). All causes of death were not valve-related. Preoperative peak (mean) gradients of 74.2 ± 23.0 mm Hg (48.6 ± 16.3 mm Hg) decreased to 15.6 ± 5.4 mm Hg (8.8 ± 3.0 mm Hg) after AVR, and remained low for up to 9 years. The postoperative effective orifice area was 1.6 ± 0.57 cm2, 1.90 ± 0.45 cm2, 2.12 ± 0.48 cm2, and 2.20 ± 0.66 cm2 for the valve sizes 21, 23, 25, and 27, respectively, with absence of severe prosthesis-patient mismatch and 0.7% (n = 1) experienced moderate prosthesis-patient mismatch. During follow-up, 26 patients experienced structural valve deterioration (SVD) and 14 patients underwent explantation. Kaplan-Meier estimates for freedom from death, explantation, and SVD at 9 years averaged 0.57 (range, 0.47-0.66), 0.82 (range, 0.69-0.90), and 0.70 (range, 0.57-0.79), respectively. ConclusionsThe Freedom Solo stentless aortic valve is safe to implant and shows excellent early and midterm hemodynamic performance. However, SVD was observed in a substantial number of patients after only 5-6 years and the need for explantation increased markedly, suggesting low durability.

Clinical Experience With the Freedom SOLO Stentless Aortic Valve in 277 Consecutive Patients

The Sorin Freedom SOLO (FS) bovine pericardial stentless valve prosthesis is designed for supraannular, subcoronary implantation. We report our experience and results with 277 consecutively implanted FS bioprostheses. 277 patients (mean age, 74.2 ± 7.3 years; 139 (50.2%) female) underwent aortic valve replacement (AVR) with the FS stentless bioprosthesis. The hemodynamic performance was investigated with transthoracic echocardiography at discharge, 6 months later, and yearly thereafter. Follow-up was 100% complete, with an average observation time of 2.6 ± 1.7 years and a total of 697.3 patient-years. The overall 30-day mortality was 4.3%. The mortalities for isolated AVR and combined procedures were 1.9% and 7.3%, respectively. No causes of death were valve-related. Preoperative peak (74.2 ± 23.0 mm Hg) and mean (48.6 ± 16.3 mm Hg) gradients decreased to 15.6±5.4mm Hg and 8.8 ± 3.0 mm Hg postoperatively andremained unchanged for as long as 5 years. The postoperative mean effective orifice area (EOA) for valve sizes 19, 21, 23,25, and 27 were 1.49 ± 0.32 cm(2), 1.67 ± 0.40cm(2), 1.92±0.38cm(2), 2.01 ± 0.42 cm(2), and 2.13 ± 0.36 cm(2), respectively. Severe prosthesis-patient mismach (PPM) was completely absent, and moderate PPM occurred in 17patients (6.1%). In isolated AVR, 0.8% of patients with preoperative sinus rhythm required a permanent pacemaker before hospital discharge. There was 100% freedom from structural valve deterioration, 99.6 % freedom from endocarditis and reoperation, and 97.3% freedom from thromboembolism at 5 years. The FS stentless aortic valve is safe to implant, and it shows excellent hemodynamic performance and early and midterm results. Owing to the favorable EOA, the valve appears particularly attractive for patients at risk for PPM.

P85 SORIN FREEDOM SOLO STENTLESS VALVE IN SURGICAL THERAPY OF AORTIC VALVE ENDOCARDITIS: INITIAL RESULTS AND MID–TERM FOLLOWUP

Background: Despite significant improvement in antibiotic therapy, aortic valve endocarditis, with or without perivalvular abscess, still represents significant surgical challenge. Homograft implantation is the gold standard of surgical therapy, but new artificial valves attract more attention due to easier availability. We present our results in utilizing the Sorin Freedom SOLO stentless aortic valve in surgical management of aortic valve endocarditis. Methods: From January 2009 until January 2013, seventeen male patients underwent aortic valve replacement due to aortic valve endocarditis utilizing the Sorin Freedom SOLO bioprosthesis made of bovine pericardium. Follow-up and postoperative echo data were collected in a prospective manner. Results: There were 9 emergent surgeries (56%), 5 urgent (31%), and 2 elective (13%). Average age was 61.5±8.74 years (range 43–76) with median EuroSCORE 10, and logistic EuroSCORE mortality 23.09±20.09% (4.4–59.7%). One patient underwent concomitant mitral valve replacement, and four patients had annular abscesses which were closed with glutaraldehyde treated autologous pericardium. Average aortic cross-clamp time for isolated aortic valve replacement was 58.81±19.25 minutes (42–98), and for combined procedures (mitral valve replacement, closure of subannular abscess) 112.8±22.6 minutes (82–141). Median valve size was 25mm (23–27). Follow up was 18.98±14.49 months (0.1–43.86). Two patients died during hospital stay due to multi-organ failure, and one died during mid-term follow-up, for an overall mortality of 18%. Early mean postoperative transvalvular gradient was 11.22±4.36 mmHg(7– 15.8), and medium-term gradient was 12.5±5.6 mmHg. During follow-up, there were neither structural valve deterioration of any kind nor prosthetic valve endocarditis. Conclusion: Because of its specific implantation technique with single supra- annular suture line, and absence of any artificial material in its design, Sorin Freedom SOLO stentless bioprosthesis is a valuable tool in surgical management of aortic valve endocarditis. Although our initial results are encouraging, further follow-up is necessary.

Single-center experience using the Freedom SOLO aortic bioprosthesis

This study reviews a single institution experience with the Freedom SOLO (Sorin Group, Saluggia, Italy) aortic bioprosthesis. Between October 2006 and February 2010, 128 patients (64 men, 64 women; mean age, 75.8 ± 5.1 years) underwent aortic valve replacement using the Freedom SOLO stentless aortic valve. The follow-up time was 36.7 ± 1.2 months and 100% complete. Concomitant procedures were performed in 77 patients (60%). The mean standard European System for Cardiac Operative Risk Evaluation was 9 ± 2.7. Grade 3 aortic stenosis was present in 73% of patients, mixed aortic stenosis and regurgitation were present in 40% of patients, and mitral regurgitation was present in 46% of patients. The mean crossclamp time was 53 ± 12 minutes for isolated Freedom SOLO aortic valve implantation and 80 ± 28 minutes for concomitant procedures, and the mean cardiopulmonary bypass time was 103 ± 31 minutes. The mean implanted valve size was 22.6 ± 1.4 mm. The mean intensive care unit and hospital stays were 2.4 ± 1.1 days and 8.8 ± 2.6 days, respectively. Three patients underwent reoperation for bleeding. The 15-day, 30-day, and perioperative mortality were all 4.6%. The 36-month survival was 95.4% ± 1.6% for the cohort with a low European System for Cardiac Operative Risk Evaluation (<9) and 88.6% ± 1.7% for the cohort with a high European System for Cardiac Operative Risk Evaluation (>9). Echocardiographic data preoperatively, immediately postoperatively, and at 3, 6, and 12 months postoperatively showed peak transvalvular gradients of 75 ± 23, 17 ± 6, 18 ± 6.5, 16 ± 6, and 16 ± 9 mm Hg, respectively (P<.001), and a mean left ventricular end-diastolic diameter of 51 ± 7, 50 ± 6, 48 ± 8, 47 ± 6, and 46.5 ± 7.5 mm, respectively (P<.05). There were only 3 cases of early mild aortic regurgitation (grade 1), which remained stable at 12 months. The Freedom SOLO stentless aortic valve has excellent early and intermediate-term results.

The Sorin Freedom SOLO stentless aortic valve: easier implantation technique with potentially less risk of complications

Aortic valve replacement by bioprosthesis is increasingly being used. Among these, stentless bioprosthesis is becoming a valid choice due to its potential hemodynamic improvement. The Sorin Freedom SOLO stentless aortic valve (FS) (Sorin Biomedica Cardio, Saluggia, Italy) is widely used, with initial and midterm promising results. It is designed to be deployed in a straightforward manner in the supraannular position with a single running suture due to its reproducible implantation technique. Few specific valve-related complications, such as transient thrombocytopenia or rare thrombotic events, are known. Our experience, after the implantation of 33 Freedom SOLO, suggests that using the classical implantation technique, the noncoronary sinus adopts a conformation that increases the difficulty of the implant. Besides, it could also be distorted increasing the risk of periprosthetic leakage and hypothetically becoming the origin of thrombus. We present an easy and safe variation in the implantation technique of the FS that decreases the technical difficulty of the implantation, reduces the risk of periprosthetic leakage, and may additionally reduce the risk of thrombosis.

The Sorin Freedom SOLO stentless aortic valve: Technique of implantation and operative results in 109 patients

The Sorin Freedom SOLO stentless aortic valve: Technique of implantation and operative results in 109 patients

Early postoperative thrombocytopenia after implantation of the Freedom SOLO stentless aortic valve

Early postoperative thrombocytopenia after implantation of the Freedom SOLO stentless aortic valve