Rate Of Structural Valve Deterioration Research Articles

Long-Term Durability of Transcatheter Aortic Valve Prostheses in Patients With Bicuspid Versus Tricuspid Aortic Valve.

Currently, there is a lack of evidence for the long-term bioprosthetic valve durability of patients with bicuspid aortic valve (BAV) following transcatheter aortic valve replacement (TAVR). This study aimed to evaluate hemodynamic outcome, structural valve deterioration, and bioprosthetic valve failure during long-term follow-up after TAVR in patients with BAV versus patients with tricuspid aortic valve (TAV). Patients with BAV and TAV who underwent TAVR between 2012 and 2020, with echocardiography followed for at least 3 years, were included. Baseline characteristics, long-term valve hemodynamic performance, structural valve deterioration, and bioprosthetic valve failure were compared between patients with BAV and TAV. A total of 170 patients with BAV and 145 patients with TAV were included. The mean duration of follow-up for patients with BAV and TAV was 5.2±1.8 and 5.0±1.7 years. No significant differences were observed in the rates of structural valve deterioration and bioprosthetic valve failure between patients with BAV and TAV: structural valve deterioration, BAV 20 (11.8%) versus TAV 16 (11.0%) at last follow-up (P=0.861); bioprosthetic valve failure, BAV 3 (1.8%) versus TAV 7 (4.8%) at last follow-up (P=0.196). More than moderate intravalvular aortic regurgitation (1.8% versus 4.8%, P=0.196) and paravalvular leak (6.5% versus 3.4%, P=0.305) were rare in both patients with BAV and patients with TAV. This study indicated satisfactory long-term valve durability of TAVR in patients with BAV. Comparable hemodynamic outcome, structural valve deterioration, and bioprosthetic valve failure could be achieved in patients with BAV and TAV during long-term follow-up after TAVR.

Prosthesis Choice in Dialysis Patients Undergoing Mitral Valve Replacement

BackgroundPatients with renal disease on dialysis have significant comorbidity limiting life expectancy; however, these patients may experience accelerated prosthetic valve degeneration. The purpose of this study was to examine the impact of prosthesis choice on outcomes in dialysis patients undergoing mitral valve replacement (MVR) at our high-volume academic center. MethodsAdults undergoing MVR were retrospectively reviewed between January 2002 and November 2019. Patients were included if they had documented renal failure and dialysis requirements before presentation. Patients were stratified by mechanical vs bioprosthetic prosthesis. Death and recurrent severe valve failure (3+ or greater) or redo mitral operation were used as primary outcomes. ResultsThere were 177 dialysis patients identified who underwent MVR. Of these, 118 (66.7%) received bioprosthetic valves, whereas 59 (33.3%) received mechanical valves. Those who received mechanical valves were younger (48 vs 61 years; P < .001) and had less diabetes (32% vs 51%; P = .019). Prevalence of endocarditis and atrial fibrillation was similar. Postoperative length of stay was not different between groups. Risk-adjusted hazard for 5-year mortality was similar between groups (P = .668). Early mortality was high, with both groups having <50% actuarial survival at 2 years. No differences were noted in rates of structural valve deterioration or reintervention. More stroke events were noted on follow-up in patients receiving mechanical valves (15% vs 6%; P = .041). Endocarditis was the leading reason for reintervention; 4 patients received repeated surgery for bioprosthetic valve failure. ConclusionsMVR in dialysis patients carries significant morbidity and increased midterm mortality. Decreased life expectancy should be considered in the tailoring of prosthesis choice to dialysis-dependent patients.

Impact of postoperative patient-prosthesis mismatch as a risk factor for early structural valve deterioration after aortic valve replacement with Trifecta bioprosthesis

BackgroundSeveral studies have reported high rates of structural valve deterioration (SVD) in the Trifecta valves. Herein, we analyzed the midterm results of the Trifecta valve and risk factors for early SVD.MethodsWe retrospectively reviewed the records of 110 patients who had undergone Trifecta implantation between January 2012 and December 2017.ResultsWe encountered seven cases of Trifecta valve failure. We performed a redo aortic valve replacement in five patients and a transcatheter aortic valve replacement in two patients. The SVD rate was 4.8% at 5 years and 6.6% at 7 years. The mean pressure gradient and peak velocity on the first postoperative echocardiogram in patients with SVD were higher than those in patients without SVD. The SVD rates with and without patient-prosthesis mismatch (PPM) were 2.8% and 12.6% at 5 years and 2.8% and 20.0% at 7 years. PPM is a risk factor for SVD. Noncoronary cusp tears were observed in all patients who had undergone redo surgery.ConclusionsThe most common cause of SVD was noncoronary cusp tear. Patients with PPM are at high risk of developing SVD.

Bioprosthetic valve dysfunction and failure after TAVI in bicuspid aortic valve stenosis during one-year follow-up according to VARC-3

BackgroundTranscatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) stenosis has become more frequent in the last years. This may pose challenges for long-time valve durability. Therefore, we aimed to evaluate the prevalence of bioprosthetic valve dysfunction (BVD) with the newest-generation devices in BAV stenosis up to one-year follow-up (FU).MethodsThe primary endpoint was defined as the prevalence of BVD during the first procedural year according to Valve Academic Research Consortium (VARC)-3 criteria. Secondary endpoints were defined as failure in device success and clinical endpoints according to VARC-3.ResultsA total of 107 patients were included. Of these, 34 subjects (31.8%) met the criteria for BVD during a mean FU of 263 ± 180 days, of which 20.2% were already documented after thirty days. Device success after one year was lower in the + BVD cohort (57.6% vs. 98.7%, p < 0.0001*). The rates of structural valve deterioration were 6.5%, non-structural valve deterioration (NSVD) 17.8%, subclinical leaflet thickening 10.3%, and endocarditis 0.9%. NSVD was foremost triggered by patient prosthesis mismatch in balloon-expandable valves. Hemodynamic valve deterioration stage 1 and 2 was confirmed in 16.8% of + BVD patients, while stage 1 and 3 bioprosthetic valve failure occurred in 1.9%. There was no impact of BVD on mortality.ConclusionThere is critical evidence of early BVD after TAVI in BAV during one-year FU in one-third of patients, also lowering device success. The most frequently observed bioprosthetic valve dysfunction was NSVD due to patient prosthesis mismatch following TAVI with a balloon-expandable valve.

The 10-year horizon: Survival and structural valve degeneration in first-generation transcatheter aortic valves

Transcatheter aortic valve replacement is an established treatment for high- or intermediate-risk patients with symptomatic aortic valve stenosis. As more low-risk patients are being treated, transcatheter heart valve durability is gaining importance. Data on structural valve deterioration beyond 8 years after transcatheter aortic valve replacement is limited. To evaluate the outcomes of transcatheter aortic valve replacement in high-risk patients with a follow-up of ≥10 years, focusing on survival and structural valve deterioration, according to the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery definitions. Only patients with a follow-up of ≥ 10 years were included in this study (n=510). Using serial echocardiographic data, the cumulative incidences of structural valve deterioration and bioprosthetic valve failure were analysed. Receiver operating characteristic analysis was used for predictor assessment. Mean age was 79.6±6.7 years, with a mean logistic EuroSCORE of 19.8±12.7%. Immediate procedural mortality was 2.9%, and 30-day mortality was 7.8%. Kaplan-Meier-estimated survival at 10 years was 10.3±1.5%. At 10 years, the cumulative incidences of severe and moderate structural valve deterioration were 4.3% and 13%, respectively, for the total population. The cumulative incidence of bioprosthetic valve failure at 10 years was 9.0%. There was a significant difference in the rates of structural valve deterioration and bioprosthetic valve failure depending on valve type: structural valve deterioration, SAPIEN 8.9% vs CoreValve 2.2% at 10 years (P=0.001); bioprosthetic valve failure, SAPIEN 13.9% vs CoreValve 6.7% at 10 years (P=0.021). Structural valve deterioration and bioprosthetic valve failure of early transcatheter heart valves was low at 10 years. The identified differences between valve types must be validated using current-generation devices in younger patients.

Long term follow up of elderly patients treated with self-expanding transcatheter aortic valve implantation; a single center experience

Abstract Background and aims The information of long term clinical performance of transcatheter heart valves is limited. Our aim is to assess the clinical outcomes and rate of structural valve deterioration (SVD) in patients after self-expanding transcatheter aortic valve implantation (TAVI) at 10-year follow-up. Methods A total of 141 consecutive patients undergoing self-expanding TAVI for native aortic valve stenosis or failed aortic surgical bioprosthesis, between 2008 and 2012 at our institution were included. We considered SVD as defined for the consensus statement from the European Association of Percutaneous Cardiovascular Interventions (European Society of Cardiology/European Association for Cardio-Thoracic Surgery). SVD cumulative incidence was calculated considering death in the absence of valve damage as a competitive risk. Results At the time of TAVI mean age was 78±5 years, male 44%. Percutaneous prosthesis implanted were self-expanding in 100% of patients (size: 26 mm in 72%, 29 mm in 28%). Mortality at 1, 5, and 10-year follow-up was 14%, 32%, and 72%, respectively. There was one death due to prosthetic valve endocarditis. Of the total cohort, 11 patients had severe SVD, with a cumulative incidence at 10 years of 8,21 (95% CI 4.09- 14.14%). The rate of SVD at 4, 6, 8, and 10 years was 0%, 1.41%, 2.83%, and 8.21%, respectively (Figure 1 and 2). Of the 11 patients with severe SVD, seven died, two patients had reintervention (both had redo TAVI), and the other two patients remain in close follow-up. In survivors at 10-year follow-up (n=41) the median of mean gradient was 8 mmHg (interquartile Rank 6–13 mmHg) and in 8.4% an prosthetic valve regurgitation ≥moderate was detected. Diabetes, chronic obstructive pulmonary disease, chronic kidney disease, previous stroke and high pulmonary systolic pressure were independent predictors of global mortality. SVD was not associated with any of studied variables (Age, arterial hypertension, obesity, chronic kidney disease, atrial fibrillation, previous aortic bioprosthesis, left ventricle function &amp;lt;50%, prosthetic valve regurgitation, valve size and ballon postdilatation) Conclusions A low rate of SVD at 10-year follow-up was observed in this serie of elderly patients with severe aortic stenosis treated with self-expanding TAVI. This study provides insights into the long-term performance of self-expanding TAVI. Funding Acknowledgement Type of funding sources: None. Cumulative incidence of SVD and deathSVD with confidence intervals

Aortic Valve Neocuspidization Using Xenologous Pericardium Versus Bioprosthetic Valve Replacement

BackgroundSurgical aortic valve replacement (SAVR) for patients with aortic valve stenosis (AS) with small aortic root is associated with a higher rate of prosthesis–patient mismatch and suboptimal clinical outcomes. Aortic valve neocuspidization using xenologous pericardium (xAVNeo) has shown a favorable hemodynamic performance. The aim was to compare 6-year clinical outcomes of xAVNeo with SAVR. MethodsBetween 2003 and 2018, 412 patients with severe AS and small aortic root received either xAVNeo (n = 114) or bioprosthesis (n = 298). After propensity matching the cohort included 222 patients. The primary endpoints were early mortality, 6-year mortality, and freedom from reoperation. Mean follow-up averaged 3.4 ± 3.1 years and was 95% complete. ResultsEarly mortality was 8.1% for the SAVR group versus 9.9% for the xAVNeo group (odds ratio, 1.25; 95% confidence interval, 0.51-2.89). The estimated survival probabilities at 6 years for the SAVR and xAVNeo cohorts were 89.9% and 88.8%, respectively (odds ratio, 1.07; 95% confidence interval, 0.49-2.34). Progressive degeneration of the neocusps resulted in a mean gradient increase from 6.1 ± 2.3 mm Hg to 22.7 ± 11.5 mm Hg (P < .0001); cusp sclerosis was the most common indication for reoperation in the xAVNeo group with a linearized rate of 1.92% versus 0.26% per patient-year (rate ratio, 7.41; 95% confidence interval, 0.95-333.7). The freedom from reoperation was 84.8% at 6 years, inferior to that of the SAVR group (100%). ConclusionsEarly clinical outcomes and 6-year survival rates after xAVNeo and SAVR were comparable. However xAVNeo using bovine pericardium was associated with a higher rate of structural valve deterioration and inferior freedom from reoperation when compared with SAVR.

Long-term Follow-up After Transcatheter Aortic Valve Replacement

BackgroundTranscatheter aortic valve replacement (TAVR) has become the standard of care in the majority of patients with symptomatic severe aortic stenosis. Data on long-term mortality and durability of transcatheter heart valves (THVs) beyond 5 years are limited. Our study aimed to assess elderly and high-risk patients’ long-term outcomes treated with TAVR in a prospective single-centre registry focusing on the durability of THVs. MethodsWe included 795 patients with severe calcific aortic stenosis treated by transfemoral TAVR between 2006 and 2011. Echocardiography was performed at baseline; discharge; 1 year; and afterward, annually, until the longest available follow-up. Mortality rates were estimated for 1, 5, 6, 7, and 8 years. The rates of structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) were assessed in accordance with consensus definitions. Outcome measures were adjudicated according to Valve Academic Research Consortium-2 (VARC-2). ResultsMedian (interquartile range) follow-up time was 1345 (316; 2015) days. One-year, 5-year, 6-year, 7-year, and 8-year overall mortality was 25.4%, 59.0%, 64.6%, 67.9%, and 69.2%, respectively. At 8 years, no significant differences in mortality were found comparing self-expanding vs balloon-expandable valves (69.5% vs 68.0%, P = 0.709) and postdilatation (PD) vs no-PD (69.4% vs 69.2%, P = 0.363). SVD was detected in 26 patients (3.3%), and 19 (2.4%) of the 795 patients had evidence of BVF during follow-up. ConclusionsOur study demonstrates good long-term results for high-risk patients who were alive up to 8 years after TAVR.

Ten year follow-up of high-risk patients treated during the early experience with transcatheter aortic valve replacement.

The long-term clinical performance of transcatheter heart valves (THV) is unknown. This study assessed the clinical outcomes, rate of structural valve deterioration (SVD) and bioprosthetic valve failure in patients after transcatheter aortic valve replacement (TAVR) to 10-year follow-up. Consecutive patients undergoing TAVI for native aortic valve stenosis or failed aortic surgical bioprosthesis, between 2005 and 2009 at our institution were included. A total of 235 consecutive patients. At the time of TAVI mean age was 82.4 ± 7.9 years. All patients were judged to be high risk, with a STS score > 8 in 53.6%. THVs implanted were the Cribier-Edwards (20.9%), Edwards SAPIEN (77.4%) or CoreValve (1.7%). Mortality at 1, 5, and 10-year follow-up was 23.4%, 63%, and 91.6%, respectively. Of the total cohort, 15 patients had structural valve deterioration/bioprosthetic valve failure, with a cumulative incidence at 10-years of 6.5% (95% CI 3.3%, 9.6%). The rate of SVD/BVF at 4, 6, 8, and 10 years was 0.4%, 1.7%, 4.7%, and 6.5%, respectively. Nine patients had moderate SVD and six patients had severe SVD. Of the six patients with severe SVD, two patients had reintervention (one patient had redo TAVR, and the second had surgical aortic valve replacement). Survivors (n = 19) at 10-year follow-up, had a mean gradient of 14.0 ± 7.6 mmHg and aortic regurgitation ≥moderate in 5%. Quality of life measures in 10-year survivors demonstrated ADLs 6/6 in 43.8%, and ambulation without a mobility aid of 62.5%. Using early generation balloon expandable THVs in a high-risk population, there was a low rate of structural valve deterioration and valve failure at 10-year follow-up. This study provides insights into the long-term performance of transcatheter heart valves and patients self-reported derived benefits.

Mechanical or biological heart valve for dialysis-dependent patients? A meta-analysis

ObjectiveThe optimal selection of prosthetic heart valve for dialysis-dependent patients remains controversial. We investigated the comparative effectiveness and safety of mechanical prosthesis (MP) and bioprosthesis (BP) for these patients. MethodsAfter the systematic review, we included studies that involved patients on dialysis undergoing aortic valve replacement or mitral valve replacement (MVR) and reported comparative outcomes of MP and BP. Meta-analysis was performed using random-effects model. We conducted a subgroup analysis based on the valve position and postoperative international normalized ratio (INR), which was extracted from either tables or methods of each study. A meta-regression was used to examine the effects of study-level covariates. ResultsWe included 24 retrospective studies without randomized-controlled trials, involving 10,164 participants (MP = 6934, BP = 3230). Patients undergoing aortic valve replacement with MP exhibited a better long-term survival effectiveness (hazard ratio, 0.64; 95% confidence interval [CI], 0.47-0.86). Conversely, studies including MVR demonstrated little difference in survival (hazard ratio, 0.90; 95% CI, 0.73-1.12). A meta-regression revealed that age had little effect on long-term survival difference between MP and BP (β = –0.0135, P = .433). MP had a significantly greater bleeding risk than did BP when INR was above 2.5 (incidence rate ratio, 10.58; 95% CI, 2.02-55.41). However, when INR was below 2.5, bleeding events were comparable (incidence rate ratio, 1.73; 95% CI, 0.78-3.82). The structural valve deterioration rate was significantly lower in MP (risk ratio, 0.24; 95% CI, 0.14-0.44). ConclusionsMP is a reasonable choice for dialysis-dependent patients without additional thromboembolic risk requiring aortic valve replacement, for its better long-term survival, durability, and noninferior bleeding risk compared with BP. Conversely, BP might be an appropriate selection for patients with MVR, given its similar survival rate and lower bleeding risk. Although our meta-regression demonstrates little influence of age on long-term survival difference between MP and BP, further studies stratifying patients based on age cut-off are mandatory.

Resheathing of self-expanding bioprosthesis: Impact on procedural results, clinical outcome and prosthetic valve durability after transcatheter aortic valve implantation

BackgroundNew transcatheter aortic valves were recently developed, enabling to resheath and reposition the prosthesis. The aim of the present study was to investigate whether the resheath manoeuvre did not impair the outcome of patients and the bioprosthesis durability after transcatheter aortic valve implantation (TAVI). Methods and resultsOn the 346 consecutive patients (84 ± 7 yrs-old, mean STS 6.7 ± 5%) undergoing a transfemoral TAVI in our institution since January 2008, 170 patients were implanted using a self-expanding valve (SEV). Among those, 39 (Group 1) required resheathing to achieve a successful implantation, while 131 did not require it (Group 2, N = 131). A balloon-expanding valve (BEV) was used in 176 patients (Group 3). Baseline characteristics were similar between groups. Device success was 98%, the rate of in-hospital death was 2%, and the number of procedural complications was similarly low, with no significant difference between groups. The follow-up was complete in 337 of 338 patients undergoing a successful TAVI (781 patients-year). Kaplan-Meier analysis showed that overall survival was 80 ± 2% and 42 ± 3% at 1 and 5 years respectively, with no difference between groups. On multivariate analysis, acute kidney injury, post-dilatation, pulmonary hypertension, porcelain aorta and STS score, but not resheath, were independant predictors of death after TAVI. The annual event rate of structural valve deterioration was 0.6% patients-year, and similar between groups. ConclusionsOur study shows that SEV resheath did not impair the procedural results, the outcome of patients nor the valve durability at short term after TAVI.

Bioprosthetic structural valve deterioration: How do TAVR and SAVR prostheses compare?

BackgroundThe durability of TAVR prostheses has come under major scrutiny since the move towards lower risk patients. We sought to compare the rate of structural valve deterioration (SVD) over time between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). MethodsWe included all TAVR and SAVR patients (age ≥ 75 years) that were performed in our centre from 2005 until 2015. Applying the internationally “agreed on” definitions of SVD, we surveyed all available serial echocardiographic follow-ups. ResultsWe included 269 TAVR and 174 SAVR cases. Post-intervention, TAVR patients had lower mean and peak gradients but higher rate of mild aortic regurgitation. SAVR patients had longer follow-up (in months, SAVR: 53 (30, 85) Vs TAVR: 33.4 (23, 52)). SVD as per Valve Academic Research Consortium-2 (VARC-2) was similar between the two groups (TAVR 28% Vs SAVR 31%; P = 0.593) but moderate haemodynamic SVD (European Association of Percutaneous Cardiovascular Intervention (EAPCI) criteria) was more common among SAVR cases (TAVR 11.5% Vs SAVR 20.7%; P = 0.007). Using Kaplan-Meier estimates, the rate of SVD over time was not different between the two groups as per VARC-2 criteria but different when moderate haemodynamic SVD criteria were applied (Log Rank P = 0.022) in favour of TAVR. The mean gradient rose steadily over time but more so post-SAVR (β = 0.52 ± 0.24 in comparison to TAVR at every given time point; P = 0.032). ConclusionStructural valve deterioration is common on long-term follow-up post-TAVR. The rate is similar to post-SAVR cases according to VARC-2 criteria but less according to the moderate haemodynamic SVD criteria.

Abstract 15470: Long Term Durability and Haemodynamic Performance of Freedom Solo Stentless Valve for Aortic Valve Replacement: A European, Multicenter Experience

Introduction: Stentless aortic valves have been developed to overcome the obstructive limitations associated with stented bioprostheses. The Freedom Solo (FS) bovine pericardial valve is a third generation stentless bioprosthesis introduced in 2004 and FDA approved in 2014. Hypothesis: The aim of the current study is to report the multi-institutional experience by the three European centers that started implanting FS extensively as first from its introduction, providing the largest series with long-term follow-up. Methods: From 2004 to 2009, 478 patients (mean age 73±8.6 years, 199 [41.6%] females) underwent isolated (n=321) or combined (n=157) aortic valve replacement (AVR) with the FS. Follow-up, including clinical and strict echocardiographic evaluation, was 97.4% complete with an average follow-up time of 6.5±3.2 years (maximum 11.4 years) and cumulative follow up was 2612 patient/years. Primary end-point was freedom from structural valve deterioration (SVD) while secondary end-points were freedom from reoperation and overall survival. Results: Overall operative mortality was 2.9% (1.5% for isolated and 5.7% for combined AVR) and none was valve-related. Preoperative peak(mean) gradients were 76.1±30.6 mmHg (47.1±18.7 mmHg) decreased to 17.7±9.1 mmHg (9.9±5.4 mmHg), stable over the follow-up. Post-operative effective orifice area was 1.8±0.6 cm2, 1.98±0.5 cm2, 2.13±0.43 cm2 and 2.21±0.56 cm2 for valve size 21, 23, 25, and 27 respectively. There was no severe prostheses-patient mismatch (PPM) and moderate PPM occurred only in 1 patient(0.2%). Twenty-four patients (5.7%) underwent reoperation (16 surgical replacement, 8 TAVR) due to endocarditis(9), blunt trauma(1), and SVD(14). SVD was reported in 5 other patients alive at time of censor. Freedom from SVD and reoperation were 90.6% [88.2-93%] and 88.3% [85.8-90.8%] respectively at 10 years follow-up, while overall actuarial survival was 55.8% [52.5-59.1%]. Conclusions: The FS valve demonstrated excellent hemodynamic performance and long-term durability in this large, multi-institutional European experience. In particular, the FS proved to be a reliable bioprosthesis in aortic position given the low rate of structural valve deterioration along with a simple implantability.

Very Long-Term Outcomes of the Carpentier-Edwards Perimount Valve in Aortic Position

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. 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. 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. 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.

Very late outcomes for mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 25-year follow-up of 450 implantations

The aim of the present study was to evaluate the very-long-term results of the Carpentier-Edwards pericardial bioprosthesis in the mitral position. 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. 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). 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.

Current status of the mechanical valve and bioprosthesis in Japan

The American College of Cardiology/American Heart Association guidelines for the management of patients with valvular heart disease were revised in 2006. These guidelines are introduced in this review, and the current status of the mechanical valve, bioprosthesis, and treatment of valvular heart disease are described based on the new guidelines as compared with the guidelines of 1998. The trend in valve selection in aortic valve replacement in the United States has been toward bioprosthesis, away from the mechanical valve. The reasons are: 1) current bioprostheses appear to have lower rates of structural valve deterioration, 2) the risks of reoperation have continued to decrease, 3) patients undergoing AVR today represent an older population than those in studies in randomized trials, 4) young patients undergoing AVR are often reluctant to accept warfarin therapy, 5) some large comparative trials have shown apparent survival benefit for patients receiving bioprostheses. In Japan, the use of tissue valves has been increasing and may continue to increase owing to the nation's aging population and to the reasons mentioned above. However, more patients received mechanical valves than bioprostheses for mitral valve replacement both in the United States and in Japan. The number of mitral valve repair cases has increased more than that of valve replacement. In selection of valve prosthesis for valve surgery, it is important that patients should decide by themselves based on mutual respect and trust between patient and doctor, with thorough discussion of the possibility of redo surgery and its risks, life-long warfarin intake, quality of life, and the patient's lifestyle and outlook on life.

Early calcification of a Carpentier-Edwards Perimount mitral valve in an elderly woman

J Thorac Cardiovasc Surg 2002;124:1043-4

The Medtronic Intact bioprosthesis: clinical and hemodynamic performance over 13 years.

We evaluated our results over 13 years with the aortic-position Medtronic Intact bioprosthesis. Our study involved 91 consecutive patients with isolated aortic valve replacement with the Medtronic Intact bioprosthesis. The follow-up was complete for 95%. Mean follow-up was 6.61 years (range 16 days-13 years), 590 patient years. Early mortality rate was 3.3%. Late mortality was 23 patients. Survival at 13 years was 53.52% (SD = 7.63%). The linearized rate of major thromboembolism was 0.34% per patient year; rate of major bleeding events was 0.33% per patient year. The rate of nonstructural dysfunction was 0.16% per patient year. Rate of reoperation was 0.53% and rate of structural valve deterioration was 0.16% per patient year. New York Heart Association (NYHA) postoperative classes were I to II in 92.21%. Gradients were as follows: 21 to 23.87 mm Hg, 23 to 18 mm Hg, 25 to 15.5 mm Hg, and 27 to 16.50 mm Hg. Structural valve deterioration was low during the 13 years of follow-up. Valve gradients and areas remained the same over the follow-up period. The Medtronic Intact bioprosthesis shows excellent clinical and hemodynamic performance at 13 years of follow up.

Carpentier-Edwards supraannular porcine bioprosthesis in aortic position: 16-year experience

Background. The aim of the study was to evaluate the long-term results of aortic valve replacement with the Carpentier-Edwards supraannular porcine bioprosthesis.Methods. A total of 278 patients who underwent aortic valve replacement between January 1983 and December 1986 were reviewed. Mean age was 69.4 ± 11.0 years (range 24 to 90 years).Results. The operative mortality was 8.6% (24 patients). The total follow-up was 2367.1 years (mean 9.3 ± 4.3 years, maximum 15.5). The late mortality rate was 6.8%/patient-year (162 patients) and the overall survival at 15 years was 26.5% ± 3.6%. Structural valve deterioration (SVD) occurred in 19 patients (linearized rate 0.8%/patient-year). The mean time to onset of deterioration was 10.9 ± 2.9 years. This time was independent of the age at the time of implantation. The freedom from SVD at 10, 12, and 15 years for patients aged less than 60 was respectively 87.6% ± 6.8%, 77.8% ± 8.9%, and 44.2% ± 12.9% (linearized rate 3.3%/patient-year). For patients aged 61 to 70 years, freedom from SVD was, respectively, 100%, 97.3% ± 2.1%, and 80.8% ± 8.3% (linearized rate 0.63% patient-year). For patients older than 70 years, it was respectively 99.1% ± 0.9%, 95.6% ± 2.6%, and 93.3% ± 3.3% (linearized rate 0.31%/patient-year). No significant difference was observed below the age of 60 years (≤50 vs 51 to 60 years) or in the older subgroups (61 to 70 years, vs >70 years).Conclusions. The Carpentier-Edwards supraannular bioprosthesis in aortic position provides low rate of structural valve deterioration at 15 years in patients aged more than 60 years at the time of implantation. The mean time to onset of SVD is independent of the subject’s age at the time of implantation. After 60 years, the risk of deterioration is low and does not present any significant variation. The Carpentier-Edwards supraannular bioprosthesis can reliably be used for aortic valve replacement in patients over the age of 60 years because, beyond this age, SVD is observed much more rarely.

Tricuspid valve supra-annular implantation in adult patients with Ebstein’s anomaly

Background. Tricuspid valve supra-annular implantation (TVSI) has been performed for adult patients with Ebstein’s anomaly at our hospital for several decades. TVSI is characterized by reliable reduction of tricuspid annulus size without affecting the conduction system; by prevention of residual tricuspid regurgitation (RTR) through preservation of the native tricuspid valve; and by implantation of the bioprosthesis at a supra-annular site. Methods. Ten adult patients with Ebstein’s anomaly underwent TVSI. The right ventricular diameter and residual tricuspid regurgitation were evaluated by echocardiography preoperatively, at discharge, 1 year after the operation, and over the long term (12.4 ± 5.5 years). Actuarial survival rate, actuarial freedom from structural valve deterioration rate, and postoperative occurrence of arrhythmia were also evaluated. Results. The actuarial survival rate at 19 years was 76 ± 15%. Tricuspid regurgitation disappeared in 8 patients just after operation. Right ventricular diameter was significantly smaller at discharge than preoperatively (63 ± 11 vs 37 ± 9, p < 0.01), and there were no significant differences between values at discharge and at follow-up. The actuarial freedom from structural valve deterioration rate and the reoperation rate were both 100%. There were no fatal complications related to arrhythmia or thromboembolism. Conclusions. TVSI is useful for adult patients with Ebstein’s anomaly. The absence of complications related to fatal arrhythmia and thromboembolism, good durability of the bioprosthesis, and a simple operative procedure are merits of this therapy.