Search

Objectives: Mitral valve replacement using a bioprosthesis remains controversial in young patients because data on long-term outcomes are missing. This study evaluated the long-term results of the PERIMOUNT pericardial mitral bioprosthesis in patients aged 65 years or younger., Methods: From 1984 to 2010, 148 Carpentier-Edwards PERIMOUNT mitral bioprostheses were implanted in 148 patients aged 65 years or younger. Baseline clinical, perioperative and follow-up data were recorded prospectively. Structural valve deterioration (SVD) was defined by strict echocardiographic assessment., Results: The mean follow-up period was 8.6 ± 5.5 years, for a total of 1269 valve-years. Operative mortality rate was 2.0%. Fifty-one late deaths occurred (linearized rate 4.0% per valve-year). Actuarial survival rates averaged 70 ± 4%, 53 ± 6% and 31 ± 7% after 10, 15 and 20 years of follow-up, respectively. Actuarial freedom from SVD at 10, 15 and 20 years was 78 ± 5%, 47 ± 7% and 19 ± 7%, respectively. Reoperation was associated with no operative mortality. Actuarial freedom from reoperation due to SVD at 10, 15 and 20 years was 82 ± 4%, 50 ± 6% and 25 ± 8%, respectively. Competing risk analysis demonstrated an actual risk of explantation secondary to SVD at 20 years of 44 ± 5%. Expected valve durability was 14.2 years for this age group., Conclusions: In the selected patients aged 65 years or younger undergoing mitral valve replacement with a pericardial bioprosthesis, the expected valve durability was 14.2 years. Reoperation for SVD was associated with a low risk of mortality.

Aims: Durability of transcatheter aortic bioprosthetic valves remains a major issue. Standardised definitions of deterioration and failure of bioprosthetic valves have recently been proposed. The aim of this study was to assess structural transcatheter valve deterioration (SVD) and bioprosthetic valve failure (BVF) using these new definitions., Methods and Results: All TAVI patients implanted up to September 2012 with a minimal theoretical five-year follow-up were included. Systematic clinical and echocardiographic follow-up was performed annually. New standardised definitions were used to assess durability of transcatheter aortic bioprosthetic valves. From 2002 to 2012, 378 patients were included. Mean age and logistic EuroSCORE were 83.3±6.8 years and 22.8±13.1%. Thirty-day mortality was 13.2%. Nine patients had SVD including two severe forms and two patients had definite late BVF. The incidence of SVD and BVF at eight years was 3.2% (95% CI: 1.45-6.11) and 0.58% (95% CI: 0.15-2.75), respectively., Conclusions: Even though limited by the poor survival of the very high-risk/compassionate early population, our data do not demonstrate any alarm concerning transcatheter aortic valve durability. Careful prospective assessment in younger and lower-risk patients and comparison with surgical bioprosthetic valves are required for further assessment of the long-term durability of transcatheter valves.

Objective: The aim of this study was to compare outcomes after rapid-deployment aortic valve replacement (RDAVR) and conventional aortic valve replacement (AVR) from two studies., Methods: Patients who underwent RDAVR (INTUITY valve) in the prospective, 5-year, single-arm multicenter TRITON study, or conventional AVR (Perimount Magna Ease valve) in the prospective Perimount Magna Ease postmarket study, were propensity score matched and compared for procedural, hemodynamic, safety, and clinical outcomes., Results: Matched RDAVR (n = 106) and conventional AVR (n = 106) patients had similar baseline characteristics (mean ± SD age, 72.8 ± 7.6 vs 72.5 ± 7.4 years; male 59.4% vs 61.3%) and procedures (concomitant procedures: 41.5% vs 50.9%). Mean ± SD aortic cross-clamp time was significantly shorter in RDAVR than AVR patients (51.8 ± 20.9 vs 73.9 ± 33.2 minutes; P < 0.001), as was mean cardiopulmonary bypass time (82.8 ± 34.2 vs 102.4 ± 41.7 minutes; P < 0.001). At 1 year, RDAVR patients showed significantly lower mean ± SD and peak aortic valve gradients (9.0 ± 3.4 and 17.0 ± 6.2 mm Hg, respectively) than conventional AVR patients (13.4 ± 5.5 and 24.2 ± 10.8 mm Hg, respectively; all P < 0.001). Patient-prosthesis mismatch was significantly less common with RDAVR than with AVR [overall: 16/66 (24.2%) vs 46/76 (60.5%); P = 0.007; severe: 2/66 (3.0%) vs 13/76 (17.1%)]. There were no significant differences between the RDAVR and AVR groups regarding 30-day safety endpoints. Survival rates in the RDAVR and conventional AVR groups were, respectively, 99.1% and 100.0% at 30 days, 97.1% and 95.1% at 1 year, and 93.3% and 94.1% at 3 years (P = nonsignificant)., Conclusions: In this retrospective study with matched populations, the RDAVR with the INTUITY valve system provided superior procedural and hemodynamic outcomes than a standard bioprosthesis without compromising safety.

Objectives: This study aimed to evaluate the safety and effectiveness of rapid-deployment aortic valve replacement (RDAVR) for severe aortic stenosis (AS)., Methods: All consecutive patients with severe AS who underwent RDAVR with the EDWARDS INTUITY bioprosthesis were prospectively included in a single-centre, cohort study between July 2012 and April 2015. Clinical examination and transthoracic echocardiography were performed preoperatively and at 1-month and 1-year follow-up., Results: We included 150 patients: mean age 76.8 ± 6.2 years, 68.7% male and mean EuroSCORE II 3.4 ± 3.7%. Implantation was successful in all: 103 (68.7%) had isolated aortic valve replacement (AVR) and 47 (31.3%) had concomitant procedures. For isolated AVR, mean cross-clamp and cardiopulmonary bypass times were 37.6 ± 13.3 and 59.9 ± 20.4 min, respectively. Overall, the 1-year Kaplan-Meier survival rate was 97.1% (95% confidence interval 92.4-98.9%). At 1 year, stroke occurred in 5 patients (3.34%), myocardial infarction in 1 (0.69%), endocarditis in 1 (0.69%), early explantation in 1 (0.67%), pacemaker implantation in 8 (5.6%) and Grade 2 periprosthetic regurgitation in 4 (3.2%; no grade 3 of 4). There were significant decreases from baseline ( P  < 0.001) in the proportion at New York Heart Association Class III/V (35.3-4.1%), mean gradient (54.9 ± 17.3 mmHg to 11.3 ± 4.8 mmHg) and mean left ventricular mass index (160.3 ± 44.8 g/m 2 to 118.5 ± 39.4 g/m 2 ). Mean indexed effective orifice area at 1 year was 1.02 ± 0.37 cm 2 /m 2 . Ten patients (6.6%) had severe patient-prosthesis mismatch., Conclusions: RDAVR for severe AS provided favourable outcomes over 1 year., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: Aortic valve replacement (AVR) using a bioprosthesis remains controversial for patients aged 50-65 years. This cohort study reports the very long-term outcomes of AVR using Carpentier-Edwards Perimount pericardial bioprosthesis in this age group., Methods: From 1984 to 2008, 522 Carpentier-Edwards Perimount pericardial aortic bioprostheses were implanted in 516 patients aged 50-65 years (mean age, 60 ± 4 years; 19% female). Multiple valve replacements were excluded fro m our cohort. Baseline demographic, perioperative and follow-up data were recorded prospectively. Mean follow-up was 9 ± 6 years, for a total of 4428 valve-years. Follow-up was complete for 97% of patients included., Results: Operative mortality rate was 2%. One hundred and forty-six late deaths occurred for a linearized rate of 3%/valve-year. Actuarial survival rates averaged 73 ± 2, 59 ± 3 and 35 ± 5% after 10, 15 and 20 years of follow-up, respectively. Mortality rate associated with reoperation was 2%. Actuarial freedom from reoperation rates due to structural valve deterioration (SVD) at 10, 15 and 20 years was respectively of 91 ± 2, 76 ± 3 and 50 ± 6%. Competing risk analysis demonstrated an actual risk of explantation secondary to SVD at 20 years of 30 ± 3%. Expected valve durability was 19 years for this age group. Age was not a significant risk factor for SVD in this middle-aged population., Conclusions: In patients aged 50-65 years undergoing AVR with the Carpentier-Edwards Perimount bioprosthesis, the expected valve durability was 19 years. Age was not a significant risk factor for SVD within this age group. Patient selection and attention to timing of reintervention may be determinants of long-term outcomes., (© The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Aortic valve replacement using a bioprosthesis remains controversial for patients younger than 60 years because of missing data on long-term outcomes in this age group., Methods: From 1984 to 2008, 383 Carpentier-Edwards Perimount pericardial aortic bioprostheses were implanted in 373 patients 60 years or younger (mean age, 51.0 ± 9.2 years; 19% female). Multiple valve replacements were excluded from our cohort. Baseline clinical, perioperative, and follow-up data were recorded prospectively. The mean follow-up was 8.6 ± 5.9 years, for a total of 3,299 valve-years. Follow-up was complete for 95.3% of patients included., Results: Operative mortality rate was 1.3%. Eighty-five late deaths occurred, for a linearized rate of 2.6%/valve-year. Actuarial survival rates averaged 78.1% ± 2.6%, 65.6% ± 3.5%, and 46.8% ± 6.0% after 10, 15, and 20 years of follow-up, respectively. Mortality rate associated with reoperation was 2.3%. Actuarial freedom from reoperation rates attributable to structural valve deterioration at 10, 15, and 20 years were, respectively, 88.3% ± 2.4%, 70.8% ± 4.1%, and 38.1% ± 5.6%. Competing risk analysis demonstrated an actual risk of explantation secondary to structural valve deterioration at 20 years of 41.6% ± 4.1%. Expected valve durability was 17.6 years for this age group., Conclusions: In selected patients 60 years or younger undergoing aortic valve replacement with the Carpentier-Edwards Perimount bioprosthesis, the expected valve durability was 17.6 years. Reoperation for structural valve deterioration was associated with a low risk of mortality., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The Carpentier-Edwards Perimount pericardial bioprosthesis (Edwards Lifesciences, Irvine, CA) has demonstrated good long-term outcomes, but its durability remains unclear depending on age at implantation. We report our 20-year experience with the Perimount valve implanted in the aortic position, with particular attention to the probability and time to reoperation required due to bioprosthesis deterioration., Methods: From 1984 to 2008 at our center, 2,659 patients (mean age, 70.7 ± 10.4 years) underwent aortic valve replacement using the Perimount pericardial bioprostheses. Patients were prospectively followed on an annual basis (mean 6.7 ± 4.8 years, range 0 to 24.6 years) with an echocardiogram at the time of follow-up. Cumulative follow-up was 18,404 valve-years. Bioprosthesis structural valve deterioration was determined by strict echocardiographic assessment., Results: Overall operative mortality was 2.8%. Actuarial survival rates including early deaths averaged 52.4% ± 1.2%, 31.1% ± 1.4%, and 14.4% ± 1.7% after 10, 15, and 20 years of follow-up, respectively. Age-stratified freedom from reoperation due to structural valve deterioration at 15 and 20 years was 70.8% ± 4.1% and 38.1% ± 5.6%, respectively, for the group aged 60 years or less, 82.7% ± 2.9% and 59.6% ± 7.6% for those 60 to 70 years, and 98.1% ± 0.8% at 15 years and above for the oldest group. Expected valve durability is 19.7 years for the entire cohort., Conclusions: With a low rate of valve-related events at 20 years, and particularly a low rate of structural valve deterioration, the Carpentier-Edwards Perimount pericardial bioprosthesis remains a reliable choice for a tissue valve in the aortic position, especially in patients over 60 years of age., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of the present study was to evaluate the very-long-term results of the Carpentier-Edwards pericardial bioprosthesis in the mitral position., Methods: From 1984 to 2011, 450 Carpentier-Edwards PERIMOUNT pericardial mitral bioprostheses were implanted in 404 consecutive patients (mean age, 68 years; 53% female). Patients undergoing multiple valve replacements were excluded. The clinical, operative, and follow-up data were prospectively recorded. The mean follow-up was 7.2±5.1 years, for a total of 3258 valve-years. The follow-up data were 97.8% complete., Results: The operative mortality rate was 3.3%. A total of 188 late deaths occurred, for a linearized rate of 5.8%/valve-year. At 20 years, the overall actuarial survival rate was 16.9%±3.9%. Age at implantation, preoperative New York Heart Association class III or IV, and redo procedure were significant risk factors affecting late survival. The actuarial freedom from complications at 20 years was thromboembolism, 83.9%±7.6%; hemorrhage, 80.2%±10.8%; endocarditis, 94.8%±1.4%; structural valve deterioration, 23.7%±6.9%; and explantation owing to structural valve deterioration, 40.5%±8.0%. The competing risk analysis demonstrated an actual risk of explantation owing to structural valve deterioration at 20 years of 25.5%±2.9%. The expected valve durability was 16.6 years for the entire cohort (11.4, 16.6, and 19.4 years for patients aged <60, 60 to 70, and >70 years, respectively)., Conclusions: With a low rate of valve-related events at 20 years and, in particular, a low rate of structural valve deterioration, the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis remains a reliable choice for a mitral tissue valve, especially in patients >60 years old., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

OBJECTIVES To compare early and long-term outcomes of minimally invasive surgery (MIS) versus full sternotomy (FS) isolated aortic valve replacement (AVR). METHODS We retrospectively analysed all patients who underwent isolated bioprosthetic AVR between 2003 and March 2012 at our institution. Matching was performed based on a propensity score, which was obtained using the output of a logistic regression on relevant preoperative risk factors. Mean follow-up was 3.1 ± 2.7 years (range 0–9.0 years) and was 99.8% complete. RESULTS A total of 2051 patients (FS, 1572; MIS, 479) underwent isolated bioprosthetic AVR during the study period. MIS patients were significantly younger (67.8 ± 11.2 vs 70.4 ± 9.4 years) and had a lower logistic EuroSCORE (6.6 ± 6.4 vs 11.2 ± 13.4%, both P < 0.001). Propensity matching resulted in 477 matched patients from each group, with no significant differences in any of the preoperative variables. Aortic cross-clamp times were significantly longer in MIS patients (59.4 ± 16.0 vs 56.9 ± 14.6 min, P = 0.008). Nonetheless, MIS AVR was associated with a significantly lower incidence of intra-aortic balloon pump usage (0.4 vs 2.1%, P = 0.042) and in-hospital mortality (0.4 vs 2.3%, P = 0.013), while FS patients had a lower rate of re-exploration for bleeding (1.5 vs 4.2%, P = 0.019). Five- and 8-year survival post-AVR was significantly higher in MIS patients (89.3 ± 2.4% and 77.7 ± 4.7% vs 81.8 ± 2.2% and 72.8 ± 3.1%, respectively, P = 0.034). Cox regression analysis revealed MIS (hazard ratio: 0.47, 95% confidence interval: 0.26–0.87) as an independent predictor of long-term survival. CONCLUSION MIS AVR is associated with very good early and long-term survival, despite longer myocardial ischaemic times. MIS AVR can be performed safely with results that are at least equivalent to those achieved through an FS. [ABSTRACT FROM PUBLISHER]