Severe Structural Valve Deterioration Research Articles

Long-term comparative outcomes in patients undergoing transcatheter aortic valve implantation with self-expanding valves versus balloon-expandable valves

ABSTRACT Background This study aimed to compare long-term clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) with self-expanding (SEV) valve versus balloon-expandable valve (BEV), with a minimum follow-up period of five years. Materials and Methods Utilizing a prospectively maintained database, this observational study identified patients who underwent TAVI using either SEV or BEV for severe aortic stenosis and were followed for at least five years. Clinical outcomes encompassed both 30-day post-TAVI outcomes and long-term outcomes, including all-cause mortality, cardiovascular mortality, structural valve deterioration (SVD), heart failure related hospitalization, bioprosthetic valve failure, and valve related hospitalization and complications. Results A total of 74 patients were included in this study, with 64 patients in the SEV group and 10 patients in the BEV group. The median follow-up duration was 6.8 years, ranging from 5.0 to 10.2 years. Throughout the post-TAVI period, the SEV group consistently demonstrated a lower mean pressure gradient than the BEV group. No significant differences were observed between the two groups in terms of short-term or long-term outcomes. Within the study, four patients encountered moderate or severe SVD and one experienced thrombosis, and no cases of bioprosthetic valve failure or endocarditis were observed. Conclusions This study revealed that SEV and BEV demonstrated comparable long-term outcomes in patients undergoing TAVI, including all-cause and cardiovascular mortality, as well as the risk of SVD.

Transcatheter aortic valve replacement with corevalve self-expanding bioprosthesis: Clinical and durability data up to 12 years

Background and aimsTranscatheter aortic valve replacement (TAVR) determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis but data on very long-term durability are lacking. We sought to evaluate the clinical and hemodynamic outcomes of the CoreValve porcine pericardial self-expanding bioprosthesis at 12-year follow-up. Methods882 inoperable or high-risk patients were treated with the CoreValve bioprosthesis in 8 Italian high-volume centers between 2007 and 2011. The endpoints were 12-year all-cause and cardiovascular mortality, and Cumulative Incidence Functions (CIFs) for severe Structural Valve Deterioration (SVD), Bioprosthetic Valve Dysfunction (BVD), Bioprosthetic Valve Failure (BVF), and severe Hemodynamic Valve Deterioration (HVD). VARC-3 definitions were applied. ResultsBaseline characteristics included a mean age of 83 ± 6 years, and NYHA class III or IV in 76.3 % of patients. The actuarial risk of death at 12 years after TAVR was 95.5 % (CI 93.5 %- 97.1 %).The actual risk of cardiovascular death, weighted against the risk of non-cardiac death at 12 years was 23.9 % (21.0 %–26.8 %). The 12-year actual risk of BVD was 7.0 % (5.3 %–8.9 %), of SVD was 3.6 % (2.5 %–5.2 %), of BVF was 3.12 % (2.02 %–4.57 %), and of severe HVD was 1.7 % (0.9 %–2.9 %). Mean transaortic gradient significantly decreased after the procedure (52 ± 15 mmHg vs 9 ± 5 mmHg, p < 0.001), and remained stable up to 12 years (12 ± 4 mmHg, P = 0.08 vs. discharge). ConclusionsThe first-generation CoreValve bioprosthesis showed reassuring clinical and hemodynamic performance at 12-year follow-up.

Five-Year Transcatheter Aortic Valve Replacement Outcomes in Chronic Hemodialysis vs. Non-Hemodialysis Patients Using Balloon-Expandable Devices.

Based on the results of a clinical trial in Japan, transcatheter aortic valve replacement (TAVR) for hemodialysis (HD) patients gained approval; however, mid-term TAVR outcomes and transcatheter aortic valve (TAV) durability in HD patients remain unexplored.Methods and Results: We analyzed background, procedural, in-hospital outcome, and follow-up data for 101 HD patients and 494 non-HD patients who underwent TAVR using balloon-expandable valves (SAPIEN XT or SAPIEN 3) retrieved from Osaka University Hospital TAVR database. Periprocedural mortality and TAVR-related complications were comparable between HD and non-HD patients. However, Kaplan-Meier analysis revealed that HD patients had significantly lower survival rates (log-rank test, P<0.001). In addition, HD patients had significantly higher rates of severe structural valve deterioration (SVD) than non-HD patients (Gray test, P=0.038). TAVR in HD patients had comparable periprocedural mortality but inferior mid-term survival and TAV durability than in non-HD patients. Indications for TAVR in younger HD patients should be carefully determined, considering the possibility of a TAV-in-TAV procedure when early SVD occurs.

Macroscopic findings of severe structural valve deterioration of a transcatheter aortic bioprosthesis.

Macroscopic findings of severe structural valve deterioration of a transcatheter aortic bioprosthesis.

Midterm results after aortic valve neocuspidization

ObjectivesAortic valve neocuspidization with autologous pericardium is gaining increasing attention as a surgical treatment option for aortic valve disease. However, little is known about midterm durability and valve-related events. MethodsPatients undergoing aortic valve neocuspidization between 2016 and 2021 were included. Transthoracic echocardiography was performed before the operation, at discharge, and annually thereafter. Data were analyzed for incidences of structural valve deterioration, bioprosthetic valve failure, survival, freedom from reoperation, and hemodynamic performance. ResultsA total of 162 patients underwent aortic valve neocuspidization (mean age, 52.6 ± 16.6 years; range, 13-78 years); 114 (70.4%) were male. A total of 132 patients presented with a bicuspid aortic valve (81.5%) and 126 patients presented with aortic valve stenosis (77.8%). Concomitant procedures were performed in 63 patients (38.9%). Mean follow-up was 3.5 ± 1.2 years. At discharge, peak and mean pressure gradients were 15.6 ± 7.2 mm Hg and 8.4 ± 3.7 mm Hg, respectively, with a mean effective orifice area of 2.4 ± 0.8 cm2. After 5 years, peak and mean pressure gradients were 14.5 ± 4.6 mm Hg and 7.5 ± 2.2 mm Hg, respectively, with a mean effective orifice area of 2.3 ± 0.8 cm2. At 5 years, cumulative incidences of moderate and severe structural valve deterioration and bioprosthetic valve failure were 9.82% ± 3.87%, 6.96% ± 3.71%, and 12.1% ± 4.12%, respectively. Survival was 97.3% ± 1.4%, and freedom from reoperation was 91.3% ± 2.4%. ConclusionsAortic valve neocuspidization accomplishes low pressure gradients early after initial surgery and during follow-up. Survival in this young patient population is excellent. The main reason for reoperation is endocarditis, and rates for structural valve degeneration are low.

Long-term valve performance of St Jude Medical Epic porcine bioprosthesis in aortic position.

The aim of this study was to review long-term clinical outcomes and valve performance after Epic Supra valve implantation in aortic position. From 2011 to 2022, 44 patients (mean age 75 ± 8years) underwent surgical aortic valve replacement (SAVR) with an Epic Supra valve at our hospital. Survival, incidence of late complications, and echocardiographic date were retrospectively analyzed. During a mean follow-up period of 6.2 ± 3.5years, the overall survival rate was 91 ± 4% at 2 and 88 ± 5% at 5years, while rates of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) were 86 ± 5% and 83 ± 6%, respectively. There was one case of reoperation for prosthetic valve endocarditis at 6years after the initial surgery. Echocardiographic examinations showed 5-year rates of freedom from severe structural valve deterioration (SVD) and moderate SVD of 100 and 92%, respectively. There was no significant increase in mean pressure gradient or decrease in left ventricular ejection fraction from 1week after surgery to the late follow-up period. Long-term clinical results and durability of the Epic Supra valve in aortic position were satisfactory.

Long-term durability of self-expanding and balloon-expandable transcatheter aortic valve prostheses: UK TAVI registry.

With expansion of transcatheter aortic valve implantation (TAVI) into younger patients, valve durability is critically important. We aimed to evaluate long-term valve function and incidence of severe structural valve deterioration (SVD) among patients ≥ 10-years post-TAVI and with echocardiographic follow-up at least 5-years postprocedure. Data on patients who underwent TAVI from 2007 to 2011 were obtained from the UK TAVI registry. Patients with paired echocardiograms postprocedure and ≥5-years post-TAVI were included. Severe SVD was determined according to European task force guidelines. 221 patients (79.4 ± 7.3 years; 53% male) were included with median echocardiographic follow-up 7.0 years (range 5-13 years). Follow-up exceeded 10 years in 43 patients (19.5%). Valve types were the supra-annular self-expanding CoreValve (SEV; n = 143, 67%), balloon-expandable SAPIEN/XT (BEV; n = 67, 31%), Portico (n = 4, 5%) and unknown (n = 7, 3%). There was no difference between postprocedure and follow-up peak gradient in the overall cohort (19.3 vs. 18.4 mmHg; p = NS) or in those with ≥10-years follow-up (21.1 vs. 21.1 mmHg; p = NS). Severe SVD occurred in 13 patients (5.9%; median 7.8-years post-TAVI). Three cases (23.1%) were due to regurgitation and 10 (76.9%) to stenosis. Valve-related reintervention/death occurred in 5 patients (2.3%). Severe SVD was more frequent with BEV than SEV (11.9% vs. 3.5%; p = 0.02), driven by a difference in patients treated with small valves (BEV 28.6% vs. SEV 3.0%; p < 0.01). Hemodynamic function of transcatheter heart valves remains stable up to more than 10 years post-TAVI. Severe SVD occurred in 5.9%, and valve-related death/reintervention in 2.3%. Severe SVD was more common with BEV than SEV.

Long-term results of a stented bioprosthetic valve in the aortic position: structural valve deterioration and valve haemodynamic deterioration of bovine pericardial and porcine valves.

This study compared the clinical outcomes of bovine and porcine bioprosthetic valves based on structural valve deterioration (SVD) and valve haemodynamic deterioration (VHD) in the aortic position. From January 1995 to December 2014, patients who underwent aortic valve replacement (AVR) using a bovine pericardial valve or porcine valve were enrolled. SVD and VHD were defined according to the mean transprosthetic gradient and the grade of aortic regurgitation on transthoracic echocardiography. The propensity score matching was used to adjust for differences in preoperative and operative characteristics. A total of 520 patients were enrolled. Of these, 372 patients underwent AVR using a bovine pericardial valve and 148 patients underwent AVR using a porcine valve. Then, 135 pairs of patients were extracted after propensity score matching. The median follow-up duration was 8.2 years (interquartile range, 5.4-11.3). Among the matched patients, no significant differences occurred in overall survival (survival at 10 years: 64.7% vs 70.9%) or cardiac death (cumulative incidence at 10 years: 14.2% vs 13.1%) between the 2 groups. The cumulative incidence of moderate or greater SVD and VHD was significantly higher in the porcine valve group than in the bovine valve group (SVD at 10 years-porcine: 29.8% vs bovine: 13%; VHD at 10 years-porcine: 19.8% vs bovine: 3.8%, respectively). However, no significant differences were noted in the cumulative incidence of severe SVD and severe VHD between the 2 groups. The bovine pericardial valve should be considered in AVR because the cumulative incidences of moderate or greater SVD and VHD were significantly lower than those of the porcine valve.

Long-term outcomes of balloon-expandable transcatheter aortic valve replacement in Japanese patients

BackgroundData on long-term outcomes of transcatheter aortic valve replacement (TAVR) in Japanese patients beyond 5 years are limited. MethodsBetween June 2010 and December 2014, 55 consecutive inoperable or high surgical risk patients underwent TAVR with SAPIEN XT valves (Edwards Lifesciences, Irvine, CA, USA) for severe aortic stenosis at our institution. Among them, 2 patients were excluded from the analysis because one was converted to open surgery during the TAVR procedure and the other could not undergo TAVR due to device delivery failure. We retrospectively analyzed long-term clinical outcomes of these 53 patients (mean age: 84.1 years; mean STS score: 8.4) who had at least a 7-year follow-up after TAVR. ResultsThe rates of freedom from all-cause and cardiovascular deaths at 7 years were 35.8 % and 79.3 %, respectively. The moderate or severe structural valve deterioration (SVD) rate at 5 and 7 years was 7.2 % and 11.4 %, respectively. The rate of bioprosthetic valve failure (BVF) at 7 years was 6.2 %. ConclusionsThe 7-year mortality rate of inoperable or high surgical risk patients treated with SAPIEN XT was high, while the cardiovascular mortality rate was acceptable. Although the poor survival rate limited the long-term assessment of SAPIEN XT valve durability, the incidence of SVD and BVF was not rare.

Outcomes of surgical bioprosthetic aortic valve replacement for aortic insufficiency

BackgroundResults and durability of aortic valve replacement in aortic stenosis are well known, but no study has focused on the results of aortic valve replacement in aortic insufficiency. AimThe aim of this retrospective study was to describe our mid-term outcomes after aortic valve replacement for aortic insufficiency. MethodsAll consecutive adult patients who underwent bioprosthetic aortic valve replacement for aortic insufficiency at two European centres (in France and Germany) between May 2005 and December 2020 were analysed. ResultsDuring the study period, 289 patients were included. Mean age was 56.9±12.5 years. Overall operative mortality was 1.5%, and the 10-year survival estimate rate was 75.0%, which was significantly lower than in the age- and sex-matched general population, with a standardized mortality ratio of 2.88 (95% confidence interval 1.96–4.08; P<0001). Freedom from aortic valve-related death was 87.6%, and from aortic valve-related reoperation was 87.4%. No patient aged>60 years was reoperated on during follow-up. Freedom from severe structural valve deterioration at 10 years was 73.3%, and freedom from moderate structural valve deterioration at 10 years was 50.3%. Freedom from major adverse valve-related events at 10 years was 69.7%. ConclusionsAlthough bioprosthetic aortic valve replacement for aortic insufficiency shows good early results, 10-year mortality and major adverse valve-related event rates in young patients may be a concern, with a reduction in life expectancy compared with the general population.

Preoperative hypomagnesemia as a possible predictive factor for postoperative increase of transvalvular pressure gradient in hemodialysis patients treated with transcatheter aortic valve implantation

Background Patients undergoing maintenance hemodialysis (HD) with severe aortic stenosis are at a high risk for bioprosthetic valve dysfunction after transcatheter aortic valve implantation (TAVI). Currently, preoperative factors that predict the occurrence of valve dysfunction after TAVI on HD patients remain to be elucidated. The aim of this study is to analyze the association between preoperative clinical factors and valve stenosis after TAVI on HD patients. Methods Twenty-four of HD patients who underwent TAVI at our institution between April 2012 and January 2016 were analyzed. The mean aortic transvalvular pressure gradient (MPG) and effective orifice area index (EOAi) were assessed by serial echocardiography. Associations between preoperative clinical factors and time-series changes in MPG were examined using mixed-effects linear regression model for repeated measures. Results Three patients developed severe structural valve deterioration with calcific valve stenosis requiring reoperation. A multivariate linear mixed-effects model showed that lower serum magnesium (sMg) levels were associated with the increase of MPG after TAVI (beta-coefficient = 0.019, p = 0.03). No correlation was observed with serum calcium, phosphorus, or intact parathyroid hormone. Time-series changes of MPG and EOAi had significant difference between lower and higher sMg group. All 3 of the patients who underwent reoperation showed lower preoperative sMgs. Conclusion Among bone-mineral metabolism markers, preoperative hypomagnesemia was associated with the increase of MPG after TAVI, suggesting that hypomagnesemia could predict post-TAVI valve dysfunction in HD patients. Further studies with larger sample sizes are warranted.

Durability of a bovine pericardial aortic bioprosthesis based on Valve Academic Research Consortium-3 echocardiographic criteria

ObjectivesThe Carpentier-Edwards Perimount Magna Ease (Edwards Lifesciences) pericardial bioprosthesis has demonstrated satisfying hemodynamics at midterm follow-up, but its durability remains unclear. We report our 10-year experience with this third-generation valve implanted in the aortic position, with particular attention to structural valve deterioration. MethodsFrom 2007 to 2016 at our center, 338 patients underwent aortic valve replacement using the Perimount Magna Ease pericardial bioprosthesis. Patients were prospectively followed (mean 6.6 ± 2.6 years) with clinical evaluation and yearly echocardiography. Follow-up was 98% complete (7 patients lost) for a total of 2238 valve-years. Bioprosthesis structural valve deterioration was determined by strict echocardiographic assessment based on the Valve Academic Research Consortium 3 criteria. ResultsOverall operative mortality was 1.2%. Actuarial survival including early deaths averaged 80.9% ± 2.2% and 66.7% ± 4.4% after 5 and 10 years of follow-up, respectively. Actuarial freedom from explantation due to structural valve deterioration at 5 and 10 years was 99.6% ± 0.4% and 88.8% ± 5.0%, respectively, and actuarial freedom of structural valve deterioration at 5 and 10 years was 98.5% ± 0.7% and 44.0% ± 6.4%, respectively. More precisely, actuarial freedom of structural valve deterioration stage 3 was 99.6% ± 0.4% at 5 years and 88.3% ± 5.0% at 10 years, whereas freedom of structural valve deterioration stage 2/3 was 98.5% ± 0.7% and 60.9% ± 7.0%, respectively. ConclusionsWith a low rate of explantation due to structural valve deterioration events at 10 years, and particularly a low rate of moderate or severe structural valve deterioration based on echocardiographic Valve Academic Research Consortium 3 criteria, the Carpentier-Edwards Perimount Magna Ease pericardial bioprosthesis remains a reliable choice for a tissue valve in the aortic position. Video Abstract [Display omitted]

Transcatheter Aortic Bioprosthesis Durability: A Single-Center Experience

BackgroundTranscatheter aortic valve implant (TAVI) is gaining momentum in the treatment of severe, symptomatic aortic valve stenosis, and its indication is expanding to lower surgical risk individuals, who are generally younger and have a long life expectancy. Therefore, transcatheter bioprostheses durability appears of critical importance. Aim of the present study is to evaluate mid-term outcomes of TAVI in a high-volume single center cohort. MethodsWe analyzed all consecutive patients (n = 408) who underwent transfemoral TAVI at a single, high-volume center, between 2007 and 2014. Study objectives were all-cause death and bioprosthetic valve failure (BVF) at long term follow-up. Structural valve deterioration (SVD), BVF and valve-related death were defined according to current international standards. Follow-up was performed by in person visit and transthoracic echocardiography, which was obtained only in a minority of patients, or phone call as per patient preference. ResultsAt a median follow-up of 1821 days, overall mortality was 64.5%, with cardiovascular disease accounting for roughly half of total deaths. Valve-related deaths occurred in 10 patients. Seventeen patients were diagnosed with BVF, and 15 required repeat intervention. Moderate and severe SVD were observed in 10 and 7 patients, respectively. In the subgroup of patients with echocardiographic mid-term follow-up (n = 76), no significant increase of transprosthetic gradients nor increase of significant regurgitation was detected. ConclusionIn the present unselected, all-comers cohort, TAVI bioprostheses appeared to have excellent durability at long-term follow-up.

Long-Term Echocardiographic Follow-Up After Transcatheter Aortic Valve Implantation to Assess Structural Valve Deterioration and Bioprosthetic Valve Failure

Indications for transcatheter aortic valve implantation (TAVI) in aortic stenosis are expanding and the life expectancy of patients following TAVI is increasing. Determining the long-term durability of TAVI valves is therefore important. Rates of long-term (≥5 years) structural valve deterioration (SVD) vary widely and there are currently no comparable data from Australia. The aim herein was to determine the incidence of haemodynamic SVD and bioprosthetic valve failure (BVF) using recently standardised definitions in a Western Australian cohort after at least 5 years. This is a retrospective cohort study of consecutive patients undergoing TAVI at Royal Perth Hospital between January 2009 and January 2015. Of 211 patients, 55 survived ≥5 years and had echocardiographic data available for review. Median time to the echocardiogram was 5.9 years (max 7.8 years); 49% male, mean age 83 years. Of the 55 survivors who had echocardiograms available ≥5 years after TAVI, four (9%) had moderate haemodynamic SVD and one (2%) had severe SVD and BVF. Our results suggest excellent long-term durability of contemporary TAVI valves in an Australian cohort with very low incidence of SVD and BVF. These findings add confidence to the expanding applications of TAVI valves.

Structural valve deterioration of the Labcor Dokimos aortic prosthesis: a single-centre experience.

The goal of this study was to assess the performance and incidence of the deterioration of the Labcor Dokimos bioprosthetic aortic valve. We performed a retrospective medical chart review of 116 patients who underwent surgical aortic valve replacement with the Labcor Dokimos aortic valve between 2010 and 2018. Abstracted data included patient demographic and echocardiographic data. Patients were divided into 2 groups: patients with structural valve deterioration (SVD) and patients without SVD. Among the patients with complete follow-up (n = 95), 10 patients were excluded because they died within a year; 85 patients were included in the final analysis. Of the 85 patients, 32 (38%) developed SVD; 22 (26%) had severe SVD, 15 (18%) of whom underwent reintervention. The most common aetiology of SVD was severe central aortic regurgitation, which was detected in 91% of the patients who had severe SVD. The average time from operation to severe SVD was 4.7 years with a minimum of 1.5 years and a maximum of 7.9 years. Bioprosthetic aortic valve deterioration due to severe aortic regurgitation is common and occurs early with the Labcor Dokimos valve. This occurrence needs to be furthered investigated in larger registries.

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

Evaluation of structural valve deterioration and bioprosthetic valve failure utilizing the new European consensus definition in patients undergoing TAVI with first-generation devices: Outcomes beyond 5 years from a single center in Turkey.

The long-term durability of transcatheter aortic bioprosthetic valves continues to be a major concern. Standardized criteria of the structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) have recently been defined. Limited studies have evaluated the long-term durability of transcatheter aortic valve implantation (TAVI) according to these new definitions. We aim to analyze the durability of TAVI beyond 5 years and to report the frequency of SVD and BVF. A total of 89 patients who had undergone TAVI and had theoretically completed at least 5 years after the procedure were included. Either a Medtronic CoreValve or an Edwards SAPIEN XT valve were implanted in the patients. New standardized definitions were used to evaluate SVD and BVF. The mean age of the patients was 78.70±6.95 years. SVD occured in 4 (4.5%) patients during 6 years of follow-up. Severe SVD was observed in 2 patients (2.2%), and these patients had the New York Heart Association class II symptoms. Both patients with severe SVD also met the criteria of BVF. Moderate SVD was observed in 2 patients (2.2%), and these patients had no valve-related symptoms. Of the 4 SVD cases, 2 were associated with increased mean transaortic gradients, whereas the remaining 2 cases were associated with intraprosthetic aortic regurgitation. All patients with SVD are still alive, and none of them have required aortic valve reintervention. Although first-generation TAVI devices were used, we determined the low rate of SVD and BVF at the 6-year follow-up. It may be suggested that there is no major concern associated with TAVI even with first-generation devices regarding long-term durability.

Serial echocardiographic evaluation of the Perimount Magna Ease prosthesis.

BackgroundThe Carpentier-Edwards Perimount Magna Ease prosthesis (PME) represents the latest generation of stented bioprostheses used for surgical aortic valve replacement (SAVR). The aim of our study was to evaluate the long-term clinical outcome and hemodynamic performance of the prosthesis with a focus on the incidence and course of structural valve deterioration (SVD) by serial echocardiographic examinations.MethodsSAVR with the PME was performed in 58 consecutive patients between 2007 and 2008. Transthoracic echocardiography was performed preoperatively, at discharge and annually during a 10-year follow-up at the German Heart Center Munich.ResultsMean age at surgery was 62±14 years. At discharge (n=57), the overall mean pressure gradient (MPG) and effective orifice area (EOA) were 15.8±4.1 mmHg and 1.8±0.4 cm2, respectively. Moderate patient-prosthesis mismatch (PPM) was present in 18 patients (32%) and severe PPM in 6 patients (11%) at discharge. Ten years following SAVR (n=33), the overall MPG was 16.6±7.3 mmHg and EOA was 1.3±0.4 cm2.Thirty-day and late mortality was 2% (n=1) and 21% (n=12), respectively. Survival at 1, 5, and 10 years was 94.7%±3.3%, 91.1%±4.1%, and 77.3%±5.9%, respectively. Freedom from reoperation at 10 years was 88.8%±4.7%. Ten years after PME implantation the cumulative incidence of any SVD, severe SVD, and bioprosthetic valve failure (BVF) was 25%±6%, 14%±5%, and 16%±5%, respectively.ConclusionsThe PME shows an excellent hemodynamic performance over the course of 10 years with development of clinically relevant SVD as late as 6 years post implant, and a 10-year incidence of severe SVD of 14%.

Impact of dialysis in patients undergoing bioprosthetic aortic valve replacement.

To determine the incidence of bioprosthetic structural valve deterioration in dialysis patients undergoing aortic valve replacement compared to that in patients without dialysis. This single-centre retrospective observational study included 1159 patients who underwent aortic valve replacement using bioprosthetic valves for aortic stenosis and/or regurgitation at our institution between 2007 and 2017 [patients with dialysis (group D, n = 134, 12%) or without dialysis (group N, n = 1025, 88%)]. To adjust for potential differences between groups in terms of initial preoperative characteristics or selection bias, a propensity score analysis was conducted. The final sample that was used in the comparison included 258 patients, as follows: 129 patients with dialysis (group D) and 129 patients without dialysis (group N). The cumulative incidences of all-cause death, cardiac death and moderate or severe structural valve deterioration were estimated using the Kaplan-Meier method. Operative mortality was significantly higher in group D than group N (9% vs 0%, P = 0.001). Kaplan-Meier analysis revealed that in group D, the incidence was significantly higher for all-cause death (P < 0.001, 50% vs 18% at 5 years), cardiac death (P = 0.001, 18% vs 5% at 5 years) and moderate or severe structural valve deterioration (P < 0.001, 29% vs 5% at 5 years) compared with group N. The incidence of structural valve deterioration in dialysis patients undergoing aortic valve replacement was higher than that in patients without dialysis. Bioprosthetic valves should be carefully selected in dialysis patients undergoing aortic valve replacement.

Long-Term Outcomes and Valve Performance in Patients Undergoing Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) is an established method for treating patients with aortic valve stenosis. We sought to determine the long-term clinical outcomes and performance of a self-expanding bioprosthesis beyond 5 years. Consecutive patients scheduled for TAVI were included in the analysis. Primary end points were all-cause and cardiovascular mortality, structural valve deterioration (SVD) and bioprosthetic valve failure (BVF), based on the VARC-2 criteria and consensus statement by ESC/EAPCI. The study prospectively evaluated 273 patients (80.61 ± 7.00 years old, 47% females) who underwent TAVI with CoreValve/Evolut-R (Medtronic Inc.). The median follow-up duration was 5 years (interquartile range: 2.9 to 6; longest: 8 years). At 1, 5, and 8 years, estimated survival rates were 89.0%, 61.1%, and 56.0%, respectively, while cardiovascular mortality was 8% at the end of follow-up. Regarding valve performance, 5% of patients had early BVF and 1% had late BVF. Concerning SVD, 16 patients (6% of the total population) had moderate SVD (91% had an increase in mean gradient), with no severe SVD cases. Five patients with SVD died during follow-up. Actual analysis of the 8-year cumulative incidence of function of moderate SVD was 5.9% (2.5% to 16.2%). At multivariate analysis, the factor that emerged as an independent predictor for future SVD, was smaller bioprosthetic valve size (HR 0.58, 95% CI 0.41 to 0.82, p = 0.002). Long-term evaluation beyond 5 years after TAVI with a self-expanding bioprosthesis demonstrated low rates of cardiovascular mortality and structural valve deterioration. Valve size was an independent predictor for SVD.