P1840Mid-term results of bioprosthetic aortic valve replacement with the Trifecta valve: A word of caution

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
P Werner ◽  
M Russo ◽  
M Seewald ◽  
I Coti ◽  
T Haberl ◽  
...  

Abstract Background Structural valve deterioration (SVD) with associated bioprosthetic valve dysfunction remains an unsolved problem, exposing patients to the risk of aortic valve re-intervention after surgical aortic valve replacement (SAVR). Several strategies have been proposed to improve prosthesis design for optimal performance. The leaflets of the Trifecta valve are mounted on the outside of the prosthetic stent to achieve a larger orifice area. Although favourable early clinical outcomes have been reported, long-term durability still needs to be assessed. Purpose The aim of the current study was to assess the mid-term overall mortality and re-intervention rate in patients who received a Trifecta valve with a follow-up >5 years. Methods Patients who underwent SAVR at our centre between 2011 and 2012 were identified in the internal, prospective database. All patients with implantation of a Trifecta valve in aortic position were included. Primary endpoints were freedom from overall mortality and from re-operation at latest follow-up (FU). Additionally, assessment of echocardiographic parameters at baseline and follow-up was performed. Results Seventy-six patients (age 77.3±9.5 years, BMI 28.6±5.8, 68% male) were included in the study. EuroScore II was 7.2% (± 7.7) while mean STS-Mortality score was 2.4±1.1%. Of all procedures, 53% were isolated aortic valve replacements, whereas concomitant procedures were performed in 47% of cases (37% CABG, 12% mitral surgery, 8% tricuspid surgery). Baseline echocardiographic assessment showed a mean pressure gradient (MPG) of 51±21 mmHG, a peak pressure gradient (PPG) of 78±36 mmHG and a peak velocity (Vmax) of 4.2±1.1 m/s. Thirty-day mortality was 7%. Freedom from overall mortality at 1 year and 5 years was 84% and 73%, respectively. Freedom from death and freedom from re-operation at latest FU (6.7±0.5 years) was 68% and 90%, respectively. In a composite endpoint analysis, freedom from death or re-intervention at latest follow up was 60%. A total of 7 patients underwent aortic valve re-interventions (re-replacements n=5, valve-in-valve n=2). Indications for re-interventions were SVD (n=5), NSVD (n=1, pannus ingrowth) and endocarditis (n=1). One case of re-stenosis occurred in a patient who was deemed not feasible for aortic valve re-intervention and died. Kaplan Meier analysis Conclusion(s) To our knowledge, this patient cohort presents with the lowest rate of freedom from re-operation (90%, 6.7±0.5 years) after SAVR with the Trifecta valve. A relatively high number of SVD and NSVD has been observed, which might be attributable to the specific leaflet mounting or the deformable valve frame of the first generation. Current results call for further investigation with prospective echocardiographic follow-up in this patient group. Acknowledgement/Funding None

Author(s):  
José Manuel Martínez-Comendador ◽  
Francisco Estevez-Cid ◽  
Miguel González Barbeito ◽  
Carlos Velasco García De Sierra ◽  
Alberto Bouzas Mosquera ◽  
...  

Abstract OBJECTIVES Durability of sutureless aortic bioprosthetic valves remains a major issue. The aim of this study was to assess structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) of the Perceval bioprosthesis using the new proposed standardized definitions. METHODS All patients who underwent aortic valve replacement with sutureless Perceval S prostheses up to September 2016 were included. Clinical and echocardiographic follow-up was performed. New standardized definitions were used to assess the durability of sutureless bioprosthetic valves. From 2013 to 2016, 214 patients were included. RESULTS The mean age and EuroSCORE II were 79 years and 2.74. Thirty-day mortality was 0.47%. The survival rate was 96.8%, 88.1% and 85.7% at 1, 3 and 4 years, respectively. The median echocardiographic follow-up was 3.28 years. The mean pressure gradient was 11.3 mmHg. No cases showed evidence of severe SVD, 17 patients had moderate SVD with a mean pressure gradient of 24 mmHg and 8 patients had definite late BVF. The incidence of moderate SVD and BVF at 4 years was 8.8% and 2.9%, respectively. CONCLUSIONS Mid-term follow-up to 6.3 years after aortic valve replacement with the Perceval bioprosthesis documents favourable haemodynamic and clinical outcomes and low rates of SVD and BVF.


2020 ◽  
Vol 32 (1) ◽  
pp. 39-46
Author(s):  
Paul Werner ◽  
Jasmin Gritsch ◽  
Sabine Scherzer ◽  
Christoph Gross ◽  
Marco Russo ◽  
...  

Abstract OBJECTIVES Despite promising short- and mid-term results for durability of the Trifecta valve, contradictory reports of early structural valve deterioration (SVD) do exist. We investigated the incidence of SVD after surgical aortic valve replacement (SAVR) with the Trifecta in our single-centre experience. METHODS Data of 347 consecutive patients (mean age 71.6 ± 9.5 years, 63.4% male) undergoing SAVR with the Trifecta between 2011 and 2017 were analysed. Clinical and echocardiographic reports were obtained with a median follow-up of 41 months (1114 patient years). RESULTS Isolated SAVR was performed in 122 patients (35.2%), whereas 225 patients (64.8%) underwent concomitant procedures. The median EuroSCORE II was 4.0 (0.9; 7.1) and 30-day mortality was 3.7% (n = 13). Kaplan–Meier estimates for the freedom of overall mortality at 1, 5 and 7 years were 88.7 ± 1.7%, 73.7 ± 2.6% and 64.7 ± 4.2%, respectively. SVD was observed in 25 patients (7.2%) with a median time to first diagnosis of 73 months. Freedom of SVD was 92.5 ± 0.9% at 5 years and 65.5 ± 7.1% at 7 years. Thirteen patients underwent reintervention for SVD (6 re-SAVR, 7 valve-in-valve), resulting in a freedom of reintervention for the SVD of 98.5 ± 1.1% at 5 years and 76.9 ± 6.9% at 7 years. CONCLUSIONS We herein report one of the highest rates of SVD after SAVR with the Trifecta. These data indicate that the durability of the prosthesis decreases at intermediate to long-term follow-up, leading to considerable rates of reintervention due to SVD.


Author(s):  
Natalie Glaser ◽  
Michael Persson ◽  
Anders Franco‐Cereceda ◽  
Ulrik Sartipy

Background Prior studies showed that life expectancy in patients who underwent surgical aortic valve replacement (AVR) was lower than in the general population. Explanations for this shorter life expectancy are unknown. The aim of this nationwide, observational cohort study was to investigate the cause‐specific death following surgical AVR. Methods and Results We included 33 018 patients who underwent primary surgical AVR in Sweden between 1997 and 2018, with or without coronary artery bypass grafting. The SWEDEHEART (Swedish Web‐System for Enhancement and Development of Evidence‐Based Care in Heart Disease Evaluated According to Recommended Therapies) register and other national health‐data registers were used to obtain and characterize the study cohort and to identify causes of death, categorized as cardiovascular mortality, cancer mortality, or other causes of death. The relative risks for cause‐specific mortality in patients who underwent AVR compared with the general population are presented as standardized mortality ratios. During a mean follow‐up period of 7.3 years (maximum 22.0 years), 14 237 (43%) patients died. The cumulative incidence of death from cardiovascular, cancer‐related, or other causes was 23.5%, 8.3%, and 11.6%, respectively, at 10 years, and 42.8%, 12.8%, and 23.8%, respectively, at 20 years. Standardized mortality ratios for cardiovascular, cancer‐related, and other causes of death were 1.79 (95% CI, 1.75–1.83), 1.00 (95% CI, 0.97–1.04), and 1.08 (95% CI, 1.05–1.12), respectively. Conclusions We found that life expectancy following AVR was lower than in the general population. Lower survival after AVR was explained by an increased relative risk of cardiovascular death. Future studies should focus on the role of earlier surgery in patients with asymptomatic aortic stenosis and on optimizing treatment and follow‐up after AVR. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02276950.


2020 ◽  
Vol 31 (3) ◽  
pp. 398-404
Author(s):  
Samuli J Salmi ◽  
Tuomo Nieminen ◽  
Juha Hartikainen ◽  
Fausto Biancari ◽  
Joonas Lehto ◽  
...  

Abstract OBJECTIVES We sought to study the indications, long-term occurrence, and predictors of permanent pacemaker implantation (PPI) after isolated surgical aortic valve replacement with bioprostheses. METHODS The CAREAVR study included 704 patients (385 females, 54.7%) without a preoperative PPI (mean ± standard deviation age 75 ± 7 years) undergoing isolated surgical aortic valve replacement at 4 Finnish hospitals between 2002 and 2014. Data were extracted from electronic patient records. RESULTS The follow-up was median 4.7 years (range 1 day to 12.3 years). Altogether 56 patients received PPI postoperatively, with the median 507 days from the operation (range 6 days to 10.0 years). The PPI indications were atrioventricular block (31 patients, 55%) and sick sinus syndrome (21 patients, 37.5%). For 4 patients, the PPI indication remained unknown. A competing risks regression analysis (Fine–Gray method), adjusted with age, sex, diabetes, coronary artery disease, preoperative atrial fibrillation (AF), left ventricular ejection fraction, New York Heart Association class, AF at discharge and urgency of operation, was used to assess risk factors for PPI. Only AF at discharge (subdistribution hazard ratio 4.34, 95% confidence interval 2.34–8.03) was a predictor for a PPI. CONCLUSIONS Though atrioventricular block is the major indication for PPI after surgical aortic valve replacement, >30% of PPIs are implanted due to sick sinus syndrome during both short-term follow-up and long-term follow-up. Postoperative AF versus sinus rhythm conveys >4-fold risk of PPI. Clinical trial registration clinicaltrials.gov Identifier: NCT02626871


2020 ◽  
Vol 9 (10) ◽  
pp. 3143
Author(s):  
Satoshi Yamaguchi ◽  
Yuka Otaki ◽  
Balaji K. Tamarappoo ◽  
Tetsuya Ohira ◽  
Hiroki Ikenaga ◽  
...  

Increase in left ventricular (LV) mass develops as a compensatory mechanism against pressure overload in aortic valve stenosis. However, long-standing LV geometrical changes are related to poor prognosis. The LV geometrical change occurs after transcatheter aortic valve replacement (TAVR). The present study aimed to investigate the relationship between improvement in valvuloarterial impedance (Zva) and change in LV mass index (LVMI) and the ratio of LVMI to LV end-diastolic volume index (LVMI/LVEDVI). We compared these relationships to that between Zva and mean pressure gradient (MPG). Baseline and follow-up transthoracic echocardiograms of 301 patients who underwent TAVR from November 2011 to December 2015 were reviewed. Spearman correlation coefficient (ρ) was used to compare ΔLVMI and ΔLVMI/LVEDVI with Zva or MPG. The correlation between ΔZva and ΔLVMI (ρ = 0.47, p < 0.001) was superior to that between ΔMPG and ΔLVMI (ρ = 0.15, p = 0.009) (p for comparison < 0.001). The correlation between ΔZva and ΔLVMI/LVEDVI was statistically significant (ρ = 0.54, p < 0.001); in contrast, that of ΔMPG and ΔLVMI/LVEDVI was not. The improvement in Zva after TAVR was more closely related to LVMI and LVMI/LVEDVI reduction than MPG reduction.


2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
R Menezes Fernandes ◽  
HA Costa ◽  
JS Bispo ◽  
TF Mota ◽  
D Bento ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Aortic stenosis (AS) is the most prevalent valvular heart disease among the elderly, reaching 8,1% in 85 years-old patients. Symptomatic severe AS entails a high risk of morbidity and mortality without valve replacement, and increasing age is associated with higher surgical risk. Purpose To determine the prognostic impact of advanced age in patients with severe AS referred to surgical valve replacement. Methods We conducted a retrospective study encompassing patients referred to surgical aortic valve replacement due to severe AS, from January 2016 to December 2018. Clinical characteristics, diagnostic studies and follow-up were analysed. Patients were divided in two groups according to the age: &lt;80 and ≥80 years old. Independent predictors of mortality and/or re-hospitalization were identified through a binary logistic regression analysis, considering p = 0,05. Results A total of 222 patients were included, with a 64,4% male predominance and a median age of 75 years old. 27,5% had concomitant surgical coronary artery disease and 87,4% waited in an out-patient setting. Median delay until surgery was 87 days and median follow-up after surgical referral was 517 days. 59 patients (26,8%) had ≥ 80 years old. Male gender (69,6% vs 50,8%; p = 0,01), smoking habits (14,3% vs 1,7%; p = 0,024), higher glomerular filtration rate (75,5 vs 63,2 ml/min; p = 0,001) and lower Euroscore II values (2,89% vs 4,64%; p = 0,003) were more common in younger patients. Global mortality rate (27,1% vs 15,5%; p = 0,05) and the composite of mortality or re-hospitalization (52,5% vs 36,6%; p = 0,034) were more frequent in older patients. Despite re-hospitalizations were also more common (37,3% vs 29,2%), they did not reach statistical significance (p = 0,252). After multivariate analysis, advanced age was not an independent predictor of mortality and/or re-hospitalization. In this population, only the presence of extracardiac arteriopathy (p = 0,007; p = 0,006) and pulmonary hypertension (p = 0,004; p = 0,002) were both independent predictors of mortality and the composite of mortality or re-hospitalization. Conclusion Older patients with AS have higher mortality, but advanced age was not an independent predictor of mortality and/or re-hospitalization. The decision to perform aortic valve replacement should be discussed in the Heart Team, considering patient’s comorbidities and performing a comprehensive geriatric evaluation, not just focusing on age itself.


BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e022437 ◽  
Author(s):  
Ratnasari Padang ◽  
Mahmoud Ali ◽  
Kevin L Greason ◽  
Christopher G Scott ◽  
Manasawee Indrabhinduwat ◽  
...  

ObjectiveThe presence of aortic paravalvular leak (PVL) is associated with lower survival, but a direct comparison of its impact after transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) has not been performed. This study sought to determine the differential influence of PVL on survival following TAVR versus SAVR and in patients with varying levels of risk as defined by the Society of Thoracic Surgeons (STS) risk score.MethodsPatients with and without postprocedural PVL were identified from 2290 patients undergoing TAVR or SAVR at Mayo Clinic between 2008 and 2014. The primary endpoint was overall survival.ResultsThere were 588 patients with PVL (374 TAVR, 214 SAVR): age 78±11 years, 63% male and mean follow-up of 3±2 years. PVL was trivial/mild in 442 (75%) patients. In propensity-matched analyses (n=86 per group), the overall survival at 1 and 4 years was 93% and 56% vs 89% and 61% in patients with PVL after TAVR versus SAVR, respectively (p=0.43). The presence or degree of PVL severity had no influence on survival of patients with high STS score (≥8%), while the presence of greater than mild PVL predicted worse survival in those with STS score <8%. During the first year after PVL diagnosis, while either improvement or stable PVL grade was seen in the majority of patients, worsening of PVL grade was more common in the TAVR group (19%) versus the SAVR group (4%) (p<0.0001).ConclusionsAt mid-term follow-up, the presence of PVL was associated with equally unfavourable outcomes following SAVR or TAVR. In patients with high STS risk score, the presence of PVL was not independently associated with increased mortality.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
E Munoz-Garcia ◽  
M Munoz-Garcia ◽  
A J Munoz Garcia ◽  
F Carrasco-Chinchilla ◽  
A J Dominguez-Franco ◽  
...  

Abstract Transcatheter Aortic valve Replacement (TAVR) has emerged as an alternative to surgical aortic valve replacement for patients considered at high or prohibitive operative risk. It is widely known the short and mid-term outcomes, however, is limited about long-term outcomes in according to age. The aim of this study was to determine the survival and the clinical outcomes on based of age. after TAVR with the CoreValve prosthesis. Methods From April 2008 to December 2017, the CoreValve and Sapiens 3 prosthesis were implanted in 667 patients with symptomatic severe aortic stenosis with deemed high risk on base to age, <80 years and ≥80 years old Results The mean age in patients <80 compared with ≥80 years, was 73.6±7 vs. 83.4±2.8 years and the logistic EuroSCORE and STS score were 16.3±11% vs. 18.1±11%. In-hospital mortality was 3.4%, and the combined endpoint of death, vascular complications, myocardial infarction, majopr bleeding or stroke had a rate of 18.3%. The late mortality (beyond 30 days) was 40.5%. When compared both groups, there were no differences for the presence of threatening bleeding 3.5% vs. 3.6% (HR = 1.033 [IC95% 0.452–2.360], p=0.557), myocardial infarction4.2% vs. 2.9% (HR = 0.67 [IC95% 0.290–1,530], p=0.0.226), stroke 8.9% vs. 9.4% (HR = 1.067 [IC95% 0.625–1.821], p=0.814) and mortality 44.5% vs. 41.1% (HR=0.971388 [IC95% 0.639–1.188], p=0.214) and there was difference in between groups in hospitalizations for heart failure 13.8% vs. 7.7% (HR = 1.374 [IC95% 1.037–1.821], p=0.008. Survival at 1, 2, 3, 4, 5 were similar in both groups (86.9% vs. 89.8%, 78.4 vs. 78.3%, 65.5 vs. 72.5%, 57.9% vs. 62.8% and 51.1 vs. 52.8%>; log Rank 0.992, p=0.319), respectively, after a mean follow-up of 43.9±27 months. Conclusions TAVR is associated with significant survival benefit throughout 3.2 years of follow-up. Survival during follow-up was similar in patients with <80 compared with ≥80 years old.


2021 ◽  
Vol 10 (24) ◽  
pp. 5776
Author(s):  
Elena Caporali ◽  
Roberto Lorusso ◽  
Tiziano Torre ◽  
Francesca Toto ◽  
Alberto Pozzoli ◽  
...  

Background: Surgical aortic valve replacement with rapid deployment bioprosthesis guarantees good hemodynamic results but carries the risk of paravalvular leaks. To address this issue, an annulus stabilization technique has been recently developed. Methods: Clinical and hemodynamic parameters from patients treated for aortic valve replacement with the rapid deployment bioprosthesis and a concomitant annulus stabilization technique were prospectively collected and retrospectively analyzed. Echocardiographic data at discharge and at 1-year follow-up were collected and analysed. Results: A total of 57 patients (mean age 74.3 ± 6.1 years) with symptomatic aortic valve stenosis underwent aortic valve replacement with the rapid deployment bioprosthesis and concomitant annulus stabilization technique (mean valve size: 23.8 ± 1.9 mm). Combined procedures accounted for 56.1%. Hospital mortality was 1.8% and a new pacemaker for conduction abnormalities was implanted in 10 patients. The pre-discharge echocardiographic control showed absence of paravalvular leaks of any degree in all patients with mean valve gradient of 9.6 ± 4.0 mmHg. The 1-year echocardiographic control confirmed the good valve hemodynamic (mean gradient of 8.0 ± 2.8 mmHg) and absence of leaks. Conclusion: In this preliminary clinical experience, the annulus stabilization technique prevents postoperative paravalvular leaks after rapid deployment aortic valve implantation, up to 1-year postoperatively. Studies on larger series are of paramount importance to confirm the long-term efficacy of this new surgical technique.


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