Cost-utility analysis of TAVI compared with surgery in patients with severe aortic stenosis at low risk of surgical mortality in the Netherlands.

BACKGROUND: There is growing evidence to support the benefits of transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis (sSAS) who are at high- or intermediate-risk of surgical mortality. The PARTNER 3 trial showed clinical benefits with SAPIEN 3 TAVI compared with SAVR in patients at low risk of surgical mortality. Whether TAVI is also cost-effective compared with SAVR for low-risk patients in the Dutch healthcare system remains uncertain. This article presents an analysis using PARTNER 3 outcomes and costs data from the Netherlands to inform a cost-utility model and examine cost implications of TAVI over SAVR in a Dutch low-risk population. METHODS: A two-stage cost-utility analysis was performed using a published and validated health economic model based on adverse events with both TAVI and SAVR interventions from a published randomized low risk trial dataset, and a Markov model that captured lifetime healthcare costs and patient outcomes post-intervention. The model was adapted using Netherlands-specific cost data to assess the cost-effectiveness of TAVI and SAVR. Uncertainty was addressed using deterministic and probabilistic sensitivity analyses. RESULTS: TAVI generated 0.89 additional quality-adjusted life years (QALYs) at a €4742 increase in costs per patient compared with SAVR over a lifetime time horizon, representing an incremental cost-effectiveness ratio (ICER) of €5346 per QALY gained. Sensitivity analyses confirm robust results, with TAVI remaining cost-effective across several sensitivity analyses. CONCLUSIONS: Based on the model results, compared with SAVR, TAVI with SAPIEN 3 appears cost-effective for the treatment of Dutch patients with sSAS who are at low risk of surgical mortality. Qualitative data suggest broader societal benefits are likely and these findings could be used to optimize appropriate intervention selection for this patient population.

Transcatheter aortic valve implantation versus surgical aortic valve replacement in severe aortic stenosis patients at low surgical mortality risk: a cost-effectiveness analysis in Belgium.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device has recently shown significant clinical benefits, compared to surgical aortic valve replacement (SAVR), in patients at low risk for surgical mortality (PARTNER 3 trial, NCT02675114). Currently in Belgium, TAVI use is restricted to high-risk or inoperable patients with severe symptomatic aortic stenosis (sSAS). This cost-utility analysis aimed to assess whether TAVI with SAPIEN 3 could lead to potential cost-savings compared with SAVR, in the low-risk sSAS population in Belgium. METHODS: A previously published, two-stage, Markov-based cost-utility model was used. Clinical outcomes were captured using data from PARTNER 3 and the model was adapted for the Belgian context using cost data from the perspective of the Belgian National Healthcare System, indexed to 2022. A lifetime horizon was chosen. The model outputs included changes in direct healthcare costs, survival and health-related quality of life using TAVI versus SAVR. RESULTS: TAVI with SAPIEN 3 provides meaningful clinical and cost benefits over SAVR, in terms of an increase in quality-adjusted life years (QALYs) of 0.94 and cost-saving of €3 013 per patient. While initial procedure costs were higher for TAVI compared with SAVR, costs related to rehabilitation, disabling stroke, treated atrial fibrillation, and rehospitalization were lower. The cost-effectiveness of TAVI over SAVR remained robust in sensitivity analyses. CONCLUSION: TAVI with SAPIEN 3 may offer a meaningful alternative intervention to SAVR in Belgian low-risk patients with sSAS, showing both clinical benefits and cost savings associated with post-procedure patient management.

A Systematic Review and Statistical Analysis of Factors Influencing the Cost-Effectiveness of Transcatheter Aortic Valve Implantation for Symptomatic Severe Aortic Stenosis.

Objective: Transcatheter aortic valve implantation (TAVI) is a disruptive technology recommended for patients with symptomatic severe aortic stenosis (sSAS). Despite being available for over 15 years in Europe, with an extensive volume of clinical and economic evaluations across all surgical risk groups, there is little evidence on the identification of the key drivers of TAVI's cost-effectiveness. This study sought to identify these factors and quantify their role. Methods: A systematic literature review was conducted to identify published economic evaluations of TAVI. This was supplemented by health technology assessment reports. The primary outcome was the likelihood of TAVI being found cost-effective. Secondary outcomes of TAVI being dominant, and the incremental health benefits of TAVI were also explored. Results: Forty-two studies, reporting 65 unique analyses, were identified. TAVI was found to be cost-effective and dominant in 74% and 20% of analyses, respectively. The latest generation balloon-expandable TAVI device (SAPIEN 3) was more likely to be found cost-effective, as was TAVI use in low-risk populations and when performed via transfemoral access route. There was heterogeneity in the approach taken to economic modelling, which may also influence estimates of cost-effectiveness. Analyses that found TAVI to be dominant always compared it to surgery and usually considered the latest generation balloon-expandable TAVI device. Largest health benefits were observed for the inoperable risk group. Conclusion: For patients with sSAS, TAVI is typically a cost-effective treatment option. There are important differences by device generation, risk group and access route. It is crucial to consider these differences when appraising the health economic evidence-base for TAVI.

Cost-Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in German Severe Aortic Stenosis Patients at Low Surgical Mortality Risk.

INTRODUCTION: In the randomized PARTNER 3 trial, transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device significantly reduced a composite of all-cause death, stroke, and rehospitalization, compared with surgical aortic valve replacement (SAVR), in patients with severe symptomatic aortic stenosis and low risk of surgical mortality. Furthermore, TAVI has been shown to be cost-effective in low-risk patients, compared with SAVR, in a number of countries. This study aimed to determine the cost-effectiveness of TAVI with SAPIEN 3 versus SAVR in Germany. METHODS: A previously published two-stage Markov-based model that captured clinical outcomes from the PARTNER 3 trial was adapted for the German context using the German Statutory Health Insurance perspective. The model had a lifetime horizon. The cost-utility analysis estimated changes in direct healthcare costs as well as survival and health-related quality of life using TAVI with SAPIEN 3 compared with SAVR. RESULTS: TAVI with SAPIEN 3 increased quality-adjusted life years (QALYs) by + 0.72 at an increased cost of €8664 per patient. The incremental cost-effectiveness/QALY ratio was €12,037, which fell below that of other cardiovascular interventions in use in Germany. The cost-effectiveness of TAVI over SAVR remained robust across multiple challenging scenarios and was driven by lower longer-term management costs compared with SAVR. CONCLUSIONS: TAVI with SAPIEN 3 appears to be a clinically meaningful, cost-effective treatment option over SAVR for patients with severe symptomatic aortic stenosis and low risk for surgical mortality in Germany. CLINICAL TRIAL REGISTRATION NUMBER: www. CLINICALTRIALS: gov identifier: NCT02675114.

Cost-Effectiveness Analysis of SAPIEN 3 Transcatheter Aortic Valve Implantation Procedure Compared With Surgery in Patients With Severe Aortic Stenosis at Low Risk of Surgical Mortality in France.

OBJECTIVES: The clinical and cost-saving benefits of transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis who are at high or intermediate risk of surgical mortality are supported by a growing evidence base. The PARTNER 3 trial (Placement of AoRTic TraNscathetER Valve Trial) demonstrated clinical benefits with SAPIEN 3 TAVI compared with SAVR in selected patients at low risk of surgical mortality. This study uses PARTNER 3 outcomes in combination with a French national hospital claim database to inform a cost-utility model and examine the cost implications of TAVI over SAVR in a low-risk population. METHODS: A 2-stage cost-utility analysis was developed to estimate changes in both direct healthcare costs and health-related quality of life using TAVI with SAPIEN 3 compared with SAVR. Early adverse events associated with TAVI were captured using the PARTNER 3 data set. These data fed into a Markov model that captured longer-term outcomes of patients, after TAVI or SAVR intervention. RESULTS: TAVI with SAPIEN 3 offers meaningful benefits over SAVR in providing both cost saving (€12 742 per patient) and generating greater quality-adjusted life-years (0.89 per patient). These results are robust with TAVI with SAPIEN 3 remaining dominant across several scenarios and deterministic and probabilistic sensitivity analyses. CONCLUSIONS: This model demonstrated that TAVI with SAPIEN 3 was dominant compared with SAVR in the treatment of patients with severe symptomatic aortic stenosis who are at low risk of surgical mortality. These findings should help policy makers in developing informed approaches to intervention selection for this patient population.

Budget impact analysis of transcatheter aortic valve replacement in low, intermediate, and high-risk patients with severe aortic stenosis in Saudi Arabia.

AIMS: A budget impact analysis (BIA) comparing transcatheter aortic valve replacement (TAVR) with SAPIEN 3 and surgical aortic valve replacement (SAVR) for severe, symptomatic aortic stenosis among patients of low, intermediate, and high surgical risk from the perspective of the public and private sectors in Saudi Arabia. MATERIALS AND METHODS: A Markov model was developed with six states to calculate the budget impact from time of either TAVR or SAVR intervention up to 5 years. We compared the budget effects of new permanent pacemaker implantation (PPI), new onset atrial fibrillation (AF), major/disabling stroke (MDS), and surgical site infections (SSI). One-way sensitivity analyses (OWSA) were performed on cost and probability inputs. RESULTS: Analysis of the base case parameters suggests TAVR vs. SAVR is budget saving among intermediate- and high-risk patients at 5 years. TAVR vs. SAVR for low surgical risk reaches budget neutrality at 5 years. TAVR is associated with higher costs for PPI and budget savings for MDS, AF, and SSI. TAVR also results in savings for non-device costs due to fewer human resource uses and shorter procedure durations. Similarly, TAVR is associated with cost savings due to shorter hospital intensive care unit (ICU) and non-ICU stays. The OWSA consistently revealed that SAVR non-device theater costs were the leading cost driver across all surgical risk levels. LIMITATIONS: This is the first budget impact analysis of its kind in Saudi Arabia and future research is needed on costing TAVR and SAVR procedures, the economic impact of SSI, and corroborating estimates for the public and private sectors. CONCLUSIONS: Payers, providers, and policymakers increasingly turn to results of BIA to inform technologies affordability decisions. TAVR with SAPIEN 3 appears to generate savings vs. SAVR from a budget impact perspective across various surgical risk levels in Saudi Arabia.

Management and Outcome of Patients Admitted With Tricuspid Regurgitation in France.

BACKGROUND: Growing evidence shows a major outcome impact and undertreatment of tricuspid regurgitation (TR), but large and comprehensive contemporary reports of management and outcome at the nationwide level are lacking. METHODS: We gathered all consecutive patients admitted with a diagnosis of likely functional TR in 2014-2015 in France from the Programme de Médicalisation des Systèmes d'Information national database and collected rate of surgery, in-hospital mortality, 1-year mortality, or heart failure (HF) readmission rates. RESULTS: In 2014-2015, 17,676 consecutive patients (75 ± 14 years of age, 51% female) were admitted with a TR diagnosis. Charlson index was ≥ 2 in 56% of the population and 46% presented with HF. TR was associated with prior cardiac surgery, ischemic/dilated cardiomyopathy, or mitral regurgitation in 73% of patients. Only 10% of TR patients overall and 67% of those undergoing mitral valve surgery received a tricuspid valve intervention. Among the 13,654 (77%) conservatively managed patients, in-hospital mortality, 1-year mortality, and 1-year mortality or HF readmission rates were 5.1%, 17.8%, and 41%, respectively, overall, and 5.3%,17.2%, and 37%, respectively, among those with no underlying medical conditions (8-fold higher than predicted for age and gender). CONCLUSIONS: This nationwide cohort of patients admitted with TR included elderly patients with frequent comorbidities/underlying cardiac diseases. In patients conservatively managed, mortality and morbidity were considerably high over a short time span. Despite this poor prognosis, only 10% of patients underwent a tricuspid valve intervention. These nationwide data showing a considerable risk and potential underuse of treatment highlight the critical need to develop strategies to improve the management and outcomes of TR patients.

An analysis of the cost-effectiveness of transcatheter mitral valve repair for people with secondary mitral valve regurgitation in the UK.

BACKGROUND AND AIMS: A proportion of chronic heart failure (CHF) patients will experience regurgitation secondary to ventricular remodeling in CHF, known as functional mitral (MR) or tricuspid (TR) regurgitation. Its presence adversely impacts the prognosis and healthcare utilization in CHF patients. The advent of interventional devices for both atrioventricular valves modifies both aspects. We present an economic model structure suitable for comparing interventions used in MR and TR, and assess the cost-effectiveness of transcatheter mitral valve repair (TMVr) plus guideline directed medical therapy (GDMT) compared with GDMT alone in people with MR. METHODS: An economic model with a lifetime time horizon was developed based on extrapolated survival data and using New York Heart Association classifications to describe disease severity in people with functional MR at high risk of surgical mortality or deemed inoperable. Cost and utility values (describing health-related quality-of-life) were assigned to patients dependent on their disease severity. The analysis was conducted from a UK National Health Service perspective. An incremental cost per additional quality-adjusted life year (QALY) was estimated, and sensitivity (one-way and probabilistic) and scenario analyses conducted. RESULTS AND CONCLUSIONS: Compared with GDMT, the use of TMVr results in an additional 1.07 QALYs and an increase in costs of £32,267 per patient over a lifetime time horizon. The estimated incremental cost per QALY gained is £30,057 and would therefore be on the threshold of cost-effectiveness at £30,000 per quality adjusted life year. Thus, from a UK reimbursement perspective, in patients with severe functional MR who are at high risk of surgical mortality or deemed inoperable with conventional surgery, TMVr plus medical therapy is likely to represent a cost-effective treatment option compared with GDMT alone. The choice of device (MitraClip or PASCAL) will need to be confirmed once further clinical data are reported.

Presentation and outcomes of mitral valve surgery in France in the recent era: a nationwide perspective.

OBJECTIVES: Unbiased information regarding the surgical management of patients with mitral regurgitation (MR) at the nationwide level are scarce and mainly US-based. The Programme de Médicalisation des Systèmes d'Information, a mandatory national database, offers the unique opportunity to assess the presentation and outcomes of all consecutive mitral valve (MV) surgeries performed in France in the contemporary era. METHODS: We collected all MV surgeries performed for MR in France in 2014-2016. MR aetiology was classified as degenerative (DMR), secondary (SMR) or Other (rheumatic or congenital disease and infective endocarditis). RESULTS: During the 3-year period, 18 167 MV surgeries were performed in France (55% repair and 45% replacement; 52% isolated). Age was 66±12 years and 59% were male. Aetiology was DMR in 42%, SMR in 16% and other in 42% including 19% with uncertain aetiologies. Overall, in-hospital mortality was 6.5% and increased with age, female gender, Charlson Comorbidity Index, type of surgery (replacement vs repair), associated surgery (combined vs isolated) and MR aetiology (all p<0.01). In-hospital mortality and rate of death/readmission for heart failure (HF) at 1 year were 3.4% and 13%, respectively for DMR (2.4% and 11% for isolated DMR) and 7.8% and 27%, respectively for SMR (5.5% and 23% for isolated SMR). Repair rate was 55% overall, 68% in DMR and 72% for isolated DMR surgery (70% of all DMR). Repair rates decreased with age, Charlson Comorbidity Index and female sex (all p<0.0001). CONCLUSION: In this cross-sectional contemporary prospective nationwide database, in-hospital mortality and 1 year rate of death and HF readmission were considerable overall and in all subsets. Repair rates were suboptimal overall especially in the elderly and women subsets. These results underline the need to develop strategies to improve management and outcomes of patients with both DMR and SMR.

Dismal Outcomes and High Societal Burden of Mitral Valve Regurgitation in France in the Recent Era: A Nationwide Perspective.

Background Although US recent data suggest that mitral regurgitation (MR) is severely undertreated and carries a poor outcome, population-based views on outcome and management are limited. We aimed to define the current treatment standards, clinical outcomes, and costs related to MR at the nationwide level. Methods and Results In total, 107 412 patients with MR were admitted in France in 2014 to 2015. Within 1 year, 8% were operated and 92% were conservatively managed and constituted our study population (68% primary MR and 32% secondary MR). The mean age was 77±15 years; most patients presented with comorbidities. In-hospital and 1-year mortality rates were 4.1% and 14.3%, respectively. Readmissions were common (63% at least once and 37% readmitted ≥2 times). Rates of 1-year mortality or all-cause readmission and 1-year mortality or heart failure readmission were 67% and 34%, respectively, and increased with age, Charlson index, heart failure at admission, and secondary MR etiology; however, the event rate remained notably high in the primary MR subset (64% and 28%, respectively). The mean costs of hospital admissions and of readmissions were 5345±6432 and 10 080±10 847 euros, respectively. Conclusions At the nationwide level, MR was a common reason for admission and affected an elderly population with frequent comorbidities. Less than 10% of patients underwent a valve intervention. All subsets of patients who were conservatively managed incurred high mortality and readmissions rates, and MR represented a major societal burden with an extrapolated annual cost of 350 to 550 million euros (390-615 million US dollars). New strategies to improve the management and outcomes of patients with both primary and secondary MR are critical and warranted.

Outcomes of a Rapid Deployment Aortic Valve Versus Its Conventional Counterpart: A Propensity-Matched Analysis.

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.

Assessment of structural valve deterioration of transcatheter aortic bioprosthetic balloon-expandable valves using the new European consensus definition.

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.

Bioprosthetic mitral valve replacement in patients aged 65 years or younger: long-term outcomes with the Carpentier-Edwards PERIMOUNT pericardial valve.

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.

Comparison of Endoaortic and Transthoracic Aortic Clamping in Less-Invasive Mitral Valve Surgery.

BACKGROUND: Less-invasive mitral valve surgery has become a widespread procedure in recent years, although mode of perfusion and aortic clamping are still debated questions. The aim of this study was to compare the results between transthoracic aortic clamping (TTC) and endoaortic clamping (EAC) in a multicenter, retrospective study. METHODS: Data from 3 centers experienced in both TTC and EAC were retrospectively analyzed. Five hundred consecutive patients undergoing less-invasive mitral valve surgery received either TTC (n = 250) or EAC (n = 250). Age, sex, logistic EuroSCORE, ejection fraction, associated procedures, and mitral valve repair rate were similar. A higher incidence of previous cardiac operations was observed in the EAC group (TTC 8.8% versus EAC 16.8%, p = 0.001). RESULTS: Clamping and cardiopulmonary bypass times were comparable between the 2 groups. Reoperation for bleeding (TTC 11.2% versus EAC 3.2%, p < 0.001), conversion to full sternotomy (6 cases in the TTC group), and hospital length of stay (TTC 9 days versus EAC 8 days, p = 0.01) were higher in the TTC group. No differences were found in respiratory failure, renal failure, major vascular complication, stroke, and in-hospital mortality rate. CONCLUSIONS: Despite recent concerns arising about EAC, this large multicenter study shows equivalence in terms of safety and effectiveness of this technique compared with TTC. Reduction in postoperative bleeding was observed in the EAC group despite the higher rate of complex redo cases.

Rapid-deployment aortic valve replacement for severe aortic stenosis: 1-year outcomes in 150 patients.

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.

Very long-term outcomes of the Carpentier-Edwards Perimount aortic valve in patients aged 50-65 years.

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.

Very Long-Term Outcomes of the Carpentier-Edwards Perimount Aortic Valve in Patients Aged 60 or Younger.

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.

Endoaortic Clamping Does Not Increase the Risk of Stroke in Minimal Access Mitral Valve Surgery: A Multicenter Experience.

BACKGROUND: Some controversy exists regarding the safety of endoaortic balloon clamping in minimal access isolated mitral valve surgery (MIMVS). The aim of this European multicenter study was to analyze the results in 10 experienced centers and compare the outcomes with published data. METHODS: The most recent 50 consecutive MIMVS cases from 10 European surgeons who had performed at least 100 procedures were prospectively collected and retrospectively analyzed. All procedures were performed through right minithoracotomy with femoral cannulation and endoaortic balloon occlusion. In-hospital and 30-day outcomes were studied. Mortality and stroke rates were compared with published median sternotomy and MIMVS outcomes. RESULTS: Mean age was 63.2 ± 12.5 years, 289 (57.8%) were male, mean logistic European system for cardiac operative risk evaluation was 6.1 ± 6.2, and 53 (10.6%) procedures had cardiac reoperations. Concomitant procedures were performed in 126 (25.9%) cases. Three patients (0.6%) required conversion to full sternotomy. Ten patients (2.0%) necessitated endoaortic balloon clamping conversion (8 to external clamping), and re-exploration for bleeding was necessary in 24 (4.8%) cases. Mean aortic cross-clamp and cardiopulmonary bypass times were 85.6 ± 30.1 and 129.5 ± 40.2 min, respectively, and were significantly longer for concomitant procedures (p < 0.001). There were no aortic dissections and no deep venous thromboses. Operative mortality (none neurologic) and major stroke occurred in 7 (1.4%) and 4 (0.8%) patients, respectively. These rates compared favorably with the published literature on isolated primary mitral valve surgery (MVS) through sternotomy or minithoracotomy (mortality rates 0.2% to 11.6%, stroke rates 0.6% to 4.4%). CONCLUSIONS: Once procedural proficiency is acquired, endoaortic balloon clamping in MIMVS is a safe and effective technique. Despite the fact that this patient cohort also includes combined and redo procedures, the observed mortality and stroke rate compared favorably with the existing literature on primary isolated mitral valve surgery irrespective of the approach.

Very long-term outcomes of the Carpentier-Edwards Perimount valve in aortic position.

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.

Minimal invasive aortic valve replacement surgery is associated with improved survival: a propensity-matched comparison.

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.