Mid-term outcomes of stentless Bio-Bentall vs. David Reimplantation for aortic root replacement.

OBJECTIVE: To compare the early and midterm clinical outcomes of patients undergoing two different surgical procedures (stentless biological Bentall [SBB] vs. valve-sparing David Reimplantation [VSDR]) for aortic root dilatation, with or without concomitant aortic valve pathology. METHODS: A population of 106 patients underwent aortic root replacement from 2004 to 2015 at our unit. Mean age at operation was 63.1 ± 10 years. The patients were retrospectively assigned to 2 groups according to surgical procedure. David operation was carried out in 52 patients (group A-VSDR) and stentless biological Bentall in 54 patients (group B-SBB). Preoperative characteristics were similar in the 2 cohorts, except for age and EuroSCORE. Mean follow-up time was 7.09 years (0.26-14.50 years), and 96% complete. Patients were evaluated and analyzed for intra-operative results and long-term clinical outcomes. RESULTS: Intraoperative mortality was 0% in both groups. Overall survival probability at 11 years was 91.8% in group A and 73.8% in group B (p = .004). Cardiac mortality at 11 years was similar in the 2 groups (p = .116). Freedom from structural valve deterioration at 11 years was 88.8% (VSDR) and 90.6% (SBB) [p = .689]. Freedom from reoperation at 11 years did not differ between the groups (83.6% VSDR vs. 98.5% SBB, p = .574). Freedom from major adverse cardiac and cerebrovascular events at 11 years was 76.7% (VSDR) versus 80.1% (SBB) (p = .542). Mean gradient at last follow-up was lower in VSDR group (8.13 vs. 11.70 mmHg, p < .001). CONCLUSIONS: David reimplantation and stentless biological Bentall procedures achieve excellent and comparable results at midterm follow-up. David operations provide superior hemodynamic performance preserved over time and may be preferred in younger, active patients.

Intermediate-Term Outcomes After Aortic Valve Replacement With the Medtronic 3F Stentless Prosthesis.

BACKGROUND: This study evaluated the early and intermediate-term clinical and hemodynamic results after implant of the Medtronic 3F (Minneapolis, MN) stentless aortic valve. METHODS: Between March 2007 and August 2015, 226 consecutive patients affected by aortic valve disease received a 3F valve at our unit by a single surgeon. The valve in 30 patients was included in a tubular prosthesis for a Bentall procedure. Size ranged between 21 and 29, age at operation was 74.17 ± 8.58 years, mean logistic European System for Cardiac Operative Risk Evaluation was 9.73 ± 6.00, and 51.3% of patients received a concomitant procedure. For isolated valve replacement, mean extracorporeal circulation time was 92 ± 17 minutes, and cross-clamp time was 73 ± 11 minutes. Follow-up was 100% complete and was a mean of 63 ± 2.4 months (range, 6-138 months). Primary end points were early and late mortality, freedom from endocarditis, freedom from structural valve deterioration, and freedom from valve-related reoperation. RESULTS: Early mortality after isolated aortic valve replacement was 1.7%. Of the 59 (25.3%) late overall deaths, 15 (6.6%) were cardiac-related, and survival rate was 93% at 10 years. At follow-up, 97% of patients were in New York Heart Association class I or II. Actuarial freedom from reoperation due to structural deterioration was 100% at 5 years and 96% at 10 years. Freedom from endocarditis at 10 years was 97%. Mean aortic pressure gradient measured by echocardiography was 11.5 mm Hg at hospital discharge and 10.4 mm Hg at the last follow-up. CONCLUSIONS: The 3F valve is a user-friendly third-generation stentless aortic prosthesis with proven durability and remarkable hemodynamic performance preserved over time. The 3F is particularly useful in cases of expected patient/prosthesis mismatch.

Successful Reoperation in 3 Cases of Failed Sorin Freedom Stentless Aortic Valve Using the LivaNova Perceval Sutureless Prosthesis.

Reoperations for deteriorated stentless bioprostheses are quite challenging procedures. Calcification of the aortic annulus and of the subcoronary root makes often impossible the removal of the failed valve, living a complex Bentall operation or a high-risk transcatheter aortic valve implantation valve-in-valve procedure as the only options, particularly in cases of small-size prostheses. The Perceval sutureless prosthesis (LivaNova PLC, London, UK) can be a valid alternative for failed stentless valve replacement. We report our experience with 3 complex cases of degenerated Sorin Pericarbon Freedom prosthesis treated successfully by means of Perceval sutureless implantation and demonstrating the reproducibility and the safety of this surgical approach.

Long-term follow-up after Bentall operation using a stentless Shelhigh NR-2000 bio-conduit.

BACKGROUND: To analyze the long-term results after Bentall operation using the stentless Shelhigh No-React (NR)-2000 bio-root prosthesis. MATERIAL: From 2004 to 2008, 26 consecutive, nonselected patients (mean age at surgery: 67 ± 9 years) underwent a Bentall operation using a stentless Shelhigh valved conduit at our institution. Mean preoperative Logistic-EuroSCORE was 17.1 ± 12.9. The mean size of the aortic root was 53.2 ± 5 mm. The mean preoperative ejection fraction was 55 ± 7.4%. Three patients had a bicuspid valve. One patient with acute endocarditis and one patient with type A aortic dissection were operated on an emergency. Three patients (11.54%) had a previous cardiac operation. The Button-Bentall technique was used in all cases. Seven patients (26.92%) received an associated procedure. The mean size of the implanted prosthesis was 26.1 ± 2.2. Follow-up ranged between 6 and 174 months (mean 93.4 ± 59.1 months). Primary endpoints consisted of early and late mortality, freedom from acute endocarditis, freedom from structural valve deterioration, and freedom from valve-related-reoperation. RESULTS: Two patients died in hospital, while 10 patients died during follow-up time, of which three for cardiac causes (12.5%). Overall survival probability was 52.9% at 15 years. Freedom from acute endocarditis was 95.7% at 5 and 15 years. Freedom from severe aortic incompetence due to structural deterioration was 100% at 5 and 10 years, 90.9% at 15 years. The mean aortic gradient at follow-up was 11.4 ± 5 mm Hg. Freedom from valve-related reoperation was 100% at 5 and 10 years, 90.9% at 15 years. CONCLUSIONS: In our experience, Bentall's operation using the Shelhigh NR-2000 stentless bio-conduit provided satisfactory early and long-term results. However, our findings are not consistent with unfavorable long-term outcomes following the implantation of this device reported by other authors.

Cell therapy and left ventricular restoration for ischemic cardiomyopathy: long-term results of a perspective, randomized study.

BACKGROUND: Aim of this study is to verify the potential advantages and benefits of bone-marrow derived autologous stem cells implantation associated to surgical left ventricular restoration (SVR), to report a new modality of cell delivery to myocardium, and to identify possible side effects of this procedure. METHODS: Between March 2007 and March 2013, 30 patients affected by ischemic dilative cardiomyopathy who received a SVR operation were enrolled in the study. The population was divided in two groups:16 patients were randomly assigned to receive stem cells therapy in addition to SVR (groupA), 14 patients received a placebo (group B). The two groups were homogeneous in respect of age, gender, preoperative NYHA class, mitral incompetence and left ventricular sizes and volumes. The patients were evaluated by echo and pet-scan before surgery and at 6 months follow-up, and by echo at subsequent follow-up. RESULTS: Overall 30 days-in hospital mortality was 0 for the entire cohort. At last follow-up ejection fraction increased from 25.3% before surgery to 36.3% in group A, and from 31.8% to 45.6% in group B. Reduction of LVEDD was 6% in group A, 9% in group B. ESLVV and EDLVD decreased more significantly in patients receiving stem cells (55% vs. 35%). Late cardiac mortality at 9 years follow-up was similar in the two groups of patients. No early or late adverse reaction nor cases of infections were observed. CONCLUSIONS: Patients affected by ischemic cardiomyopathy have a favourable outcome after SVR. A higher reduction of LVEDV and LVESV assessed by CT-Scan evaluation in patients receiving cell therapy, when compared to control group, encourages the evolution and refinement of myocardial regenerative therapy added to SVR.

Long-term outcomes using the stentless LivaNova-Sorin Pericarbon Freedom™ valve after aortic valve replacement.

OBJECTIVES: Information on the long-term safety, efficacy and durability of third-generation stentless aortic valves is lacking. METHODS: In this single-centre, single-surgeon retrospective observational study, between 2003 and 2015, consecutive, non-selected aortic valve replacement (AVR) patients were implanted with the LivaNova-Sorin Pericarbon Freedom™, a third-generation stentless aortic xenograft. Changes in clinical and echocardiographic parameters were examined, as were mortality, structural valve deterioration and reoperation, according to age at 5, 10 and 14 years. RESULTS: The mean logistic EuroSCORE was 8.5% in 22 AVR patients (mean age 68.3 years; range 15-89 years). Many patients [n = 139 (43%)] underwent a concomitant procedure. Before AVR, 68.0% of patients were in New York Heart Association (NYHA) Class I or II, and at discharge, mean gradient was 10.0 ± 4.3 mmHg. Follow-up lasted up to 8.9 ± 2.8 years. At the last follow-up, 95.6% of patients were in New York Heart Association Class I or II, the mean gradient was 8.0 ± 3.5 mmHg (P < 0.001) and reduction in interventricular septum thickness and improvement of ejection fraction were significant (both P < 0.001). Early 30-day in-hospital mortality was 1.6% overall and 0% in the AVR-only population. Overall survival probability was 99.9%, 87.9% and 82.7% at 5, 10 and 14 years. Freedom from structural valve deterioration at 14 years was 67.5%, 88.9% and 68.2% in AVR patients overall, in those aged >70 years and in those aged 60-70 years, respectively. Freedom from reoperation at 14 years was 70.3%, 88.3% and 78.0% in the corresponding groups. CONCLUSIONS: Sorin Pericarbon Freedom is a valuable aortic bioprosthesis with favourable haemodynamics, particularly in smaller annuli, and durability similar to that of stented valves, which make Sorin Pericarbon Freedom a useful option in AVR.

Benefits and medium-term outcome of the Sorin Pericarbon Freedom stentless aortic prosthesis in cases of acute bacterial endocarditis.

OBJECTIVES: The aim of this study is to evaluate the ease of use and the advantages of Sorin Pericarbon Freedom (SPF) stentless valve in cases of acute bacterial endocarditis and to check the intermediate-term results after the implant of SPF with respect to resistance to infection, valve deterioration and durability. METHODS: Between June 2003 and February 2015, 26 patients with active aortic valve bacterial endocarditis underwent aortic valve replacement with SPF pericardial stentless aortic prosthesis. The mean age was 57 ± 18 years; 73% of the patients were in preoperative NYHA class III and VI. Mean Logistic EuroSCORE was 14.2 ± 12.7. Endocarditis occurred in 18 patients with native valves, and in 9 patients with prosthetic valves (4 mechanical aortic valve prostheses; 5 aortic bioprostheses). Aortic root abscesses were observed in 16 cases (61.5%). Surgery was emergent in 3 cases (11.5%). Redo surgery was performed in 9 cases (35%). Cumulative follow-up was 126.8 patient-years (mean 4.9 ± 3.3 years). RESULTS: Operative hospital mortality was 0% for all patients. Residual mean prosthetic gradient at discharge was 9.4 ± 3.6 mmHg. Neither residual aortic incompetence nor residual abscess cavity was observed at discharge. Mean ejection fraction at discharge was 54 ± 8% (Min; Max: 35%; 65%). A total of 4 patients died at follow-up, all for non-cardiac causes. One patient was lost to follow-up. Two patients (8%) underwent non-valve-related reoperation with 0% mortality. Residual mean gradient at follow-up was 7.2 ± 2.1 mmHg. Three patients (17%) presented with mild/moderate aortic incompetence and 89% of patients were in NYHA Class I-II at follow-up. At 9 years, actuarial freedom from valve-related reoperation and from structural valve deterioration was 100%. CONCLUSIONS: The SPF aortic prosthesis is a true pericardial stentless prosthesis suitable for the treatment of acute bacterial endocarditis. Intermediate-time results in terms of freedom from reoperation, structural valve deterioration and resistance to infections are satisfactory. Haemodynamic performances are excellent since a complete exclusion of aortic root abscesses is achieved without any reduction of the aortic annular diameter, usually due to marsupialization or patch closure of the infected cavities.