scholarly journals Long-term performance of a transfemorally implantable nonmetallic, retrievable and repositionable aortic valve in patients with severe aortic stenosis 4 year follow-up of the 22F-direct flow medical

2013 ◽  
Vol 34 (suppl 1) ◽  
pp. P5407-P5407
Author(s):  
K. Bijuklic ◽  
T. Tuebler ◽  
H. Reichenspurner ◽  
H. Treede ◽  
J. Schofer
2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
B Lattuca ◽  
A Meilhac ◽  
C Robert ◽  
D Vandenbergh ◽  
F Manna ◽  
...  

Abstract Background With the growing indications of transcatheter aortic valve implantation (TAVI) worldwide and among lower risk patients, valve durability has become a crucial issue. Purpose To assess mid and long-term evolution of different generations of percutaneous balloon-expandable prostheses, predictive factors of valve deterioration and its correlation with long-term mortality. Methods All consecutive patients undergoing TAVI for severe aortic stenosis with balloon-expandable prosthesis between 2009 and 2014 and with a minimum follow-up of one-year were included in this monocentric prospective study. All echocardiograms were reviewed by two independent experts. Clinical events were defined according to the Valve Academic Research Consortium criteria. Valve deterioration was defined according to the 2017 EAPCI-ESC-EACTS international consensus statement at the longest follow-up. Results A total of 160 patients were included with a median follow-up of 3.4 years [1.5–4.9] and a maximum of 8 years. Patients were mostly implanted with the first generation Sapien XT valve (n=138, 86.2%). Median age was 85 [79–86] years, with 42.5% of women and a median logistic Euro-SCORE of 14.2% [10.6–23.2]. Immediately after TAVI, mean aortic gradient decreased dramatically from 51±12mmHg to 9±2.6mmHg (p<0.0001) and remained overall stable with a mean gradient of 12±1mmHg at 8 years. Valve deterioration occurred in 5.6% (n=9) of patients, of which 3.7% (n=6) with severe deterioration. Moderate or severe peri-prosthetic aortic regurgitation was observed in 2.5% (n=4) of patients. The eight-year survival rate was 12.9%. During follow-up, hospitalization for acute heart failure was required for 23.7% (n=38) of patients, a myocardial infarction or a stroke occurred respectively among 1.9% (n=3) and 5% (n=8) of patients. After multivariate analysis, size or generation of valves were not independent predictive factors of valve deterioration. Evolution of mean aortic gradient Conclusions After a maximal 8-year follow-up, valve deterioration after balloon-expandable TAVI is very low. In this high-risk population, TAVI seems to be a safe and durable alternative to surgery in severe aortic stenosis regardless of prosthesis generation. Acknowledgement/Funding Edwards Lifesciences


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Vassilis Voudris ◽  
Sofia Thomopoulou ◽  
Manolis Vavuranakis ◽  
Maria Kariori ◽  
Christos Stefopoulos ◽  
...  

Introduction: Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement for patients (pts) with severe aortic stenosis considered inoperable or at high operative risk. However, little is known about long-term outcomes following TAVI. In this study we assessed the 4-year clinical and echocardiographic outcomes of pts undergoing TAVI with the self expanding Medtronic CoreValve prosthesis. Methods: The 4-year outcomes following successful TAVI with the self-expanding aortic valve device (Medtronic CoreValve) were evaluated in 60 pts (mean age 79+6 years, male 47 %, Logistic Euroscore 28.43+10.93%). Principal outcome measures were death from any cause. An echocardiograpic examination was performed at prespecified intervals of 6 and 12 months, and every year afterwards. Categorical variables were compared using X2 test, and continuous variables using t test. Survival curves were also constructed. Results: All cause mortality at 1, 2, 3, and 4 years was 16.7%, 28.3%, 30%, and 40% respectively. Mean aortic valve gradient decreased from 50.96+18.6 mm Hg pre to 9.22+ 4.6 mm Hg after TAVI (P<0.001) and remained at 15.69+6.3 mm Hg at 4 years (p for post-TAVI trend <0.01). Mean aortic valve area increased from 0.66+ 0.14 cm2 pre to 1.87+0.33 cm2 after TAVI (p<0.001) and remained at 1.23+ 0.25 cm2 at 4 years (p for post-TAVI trend <0.01). Paravalvular leak (minimal to moderate) was observed in 61% of pts post-TAVI; however, there was no case of progression to severe regurgitation at 4 years follow-up. Conclusions: TAVI with the Medtronic CoreValve prosthesis is associated with sustained clinical and functional cardiovascular benefits in inoperable or high-risk patients with symptomatic aortic stenosis up to 4-year follow-up.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M Munoz-Garcia ◽  
E Munoz-Garcia ◽  
A J Munoz Garcia ◽  
A J Dominguez-Franco ◽  
J H Alonso-Briales ◽  
...  

Abstract   Transcatheter Aortic valve Replacement (TAVR) has emerged as paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Clinical and performance data on long-term TAVR are still limited. The aim of this study was to determine the survival and the factors predicting mortality after TAVR with the first and second generation of prostheses. Methods From April 2008 to December 2019, the auto-expandible prostheses were implanted in 765 patients with symptomatic severe aortic stenosis with deemed high risk. The first generation prostheses included CoreValve and Accutrak System and the second prostheses included Evolut R and Pro. Results The mean age was 79.4±6.6 years. The logistic EuroSCORE and STS score were 17.1±11% and 5.7±3.9%, respectively. The implantation success rate was 98.87%. In-hospital mortality was 3.7%, and the combined endpoint of death, vascular complications, myocardial infarction or stroke had a rate of 15.1%. The clinical outcomes in according to prosthesis generation were, for pacemaker requirement (CoreValve vs. Accutrak system vs. Evolut R vs. and Evolut pro) 35.3% vs. 26.1% vs. 14.3% vs. 14%, p=0.001; and the paravalvular aortic regurgitation, were: none 28% vs. 44.8% vs. 43.3% vs. 58; mild 40% vs. 32.3% vs. 30.8% vs. 35.2%; moderate 32% vs. 20.3 vs. 23.9% vs. 5.7%; severe 0% vs. 2.6% vs. 0% vs. 1.1, p 0.001 The late mortality (beyond 30 days) was 35.9%. Survival at 1, 3, 5, 7 and 9 years were 88.9%, 76.1%, 61.1%, 44% and 32.6% respectively, after a mean follow-up of 42.3±27 months. The NYHA functional class improved from 3.1±0.6 to 1.77±0.7 in the follow-up. At 5 years, 5 patients had severe prosthetic valve dysfunction (severe stenosis and moderate transvalvular regurgitation The predictors of cumulative mortality were: Charlson index [HR 1.25 (95% CI 1.077–1.461), p=0.004], Readmision Heart Failure [HR 3.02 (95% CI 1.554–5.879), p=0.001], stroke post-TAVR [HR 3.472 (95% CI 1.115–10.53), p=0.032], residual aortic regurgitation [HR 1.45 (95% CI 1.093–1.934), p=0,010], and severe pulmonary hypertension [HR −0.983 (95% CI 0.645–0.423) p=0.032]. Conclusions TAVR is associated with significant survival benefit throughout 3.09 years of follow-up. Survival during follow-up depends particularly among patients with associated comorbidities and cardiac markers such as aortic regurgitation or pulmonary hypertension FUNDunding Acknowledgement Type of funding sources: None.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Spampinato ◽  
R Bochen ◽  
G Stoeger ◽  
F Sieg ◽  
T Noack ◽  
...  

Abstract Background The presence of early stages of renal injury (AKI) and biomarkers has been associated with adverse outcomes in cardiac surgery. Purpose We aimed to determine whether preoperative AKI is associated with long-term all-cause mortality in patients with severe aortic stenosis (AS) undergoing surgical aortic valve replacement (SAVR) and if the combination of AKI with multi-elevated biomarkers (Amino-terminal pro-B-type natriuretic peptide, BNP; high-sensitivity cardiac troponin T, hsTNT; and C reactive protein, CRP) has a better prognostic utility. Method From a prospective registry of patients with AS referred for SAVR, 560 participants (68±8.8 years; 329 men) were retrospectively included when echocardiograms, serum creatinine and biomarkers were available within 30-days before surgery. Kaplan-Meier (KM) curves for all-cause mortality were created for groups of patients based on the presence of AKI, defined as a stage I or more according to the Acute Kidney Injury Network classification. To further describe the utility of multi-elevated biomarkers, 4 groups were created and the KM-curves and c-statistics evaluated. Mean follow-up was 737±410 days and 30 (5.4%) patients died. Results Patients with preoperative AKI (n=68) were significantly older (70±7.6 vs. 67±8.9 years, p=0.02), more likely to have hypertension, diabetes, a worse functional class (NYHA III-IV: 59% vs. 36%, p<0.001), worse glomerular filtration rate (60±20 vs. 81±26, p<0.001), an elevation of multiple biomarkers (hsTNT, BNP, and CRP), and a higher logistic-EuroScore (3.8±2.8 vs. 3.0±2.2, p=0.04). But there were no differences in the incidence of coronary artery disease, LVEF (57±10 vs. 59±11%), aortic valve area index, or in surgical characteristics. Those patients with AKI exhibited higher 3-year all-cause mortality (11.7% vs. 5.7%, p=0.04). Interestingly, the combination of AKI with 3 elevated biomarkers was associated with a more than fourfold increase in 3-year all-cause mortality (47.5% vs. 4.3%, p<0.0001), and the c-statistics (AUC 0.599 vs 0.710, p<0.001) suggested a better prediction for long-term death. Figure 1 Conclusions This study demonstrates an adverse association of preoperative AKI with survival following SAVR, which was accentuated when combined with multi-elevated biomarkers, suggesting the need for less invasive strategies and/or closer postoperative follow–up in such patients.


1980 ◽  
Vol 3 (3) ◽  
pp. 168-172 ◽  
Author(s):  
W.H. Wain ◽  
R. Greco ◽  
A. Ignegeri ◽  
E. Bodnar ◽  
D.N. Ross

Homograft valve replacement of the diseased aortic valve with a homologous aortic valve inserted in the sub-coronary position was first performed in July 1962 (Ross 1962). The procedure of transferring the patients autologous pulmonary valve to the aortic position has been used since 1967 (Ross 1967). The long term performance of homograft valves has not been regarded as satisfactory in some centres (Cope-land 1977, Anderson & Hancock 1977) whereas others have shown it to be an excellent valve replacement (Barratt-Boyes, 1977, Bodnar et al 1979). The differing experiences may be the results of alternative methods of sterilization, preservation and surgical insertion. This paper presents information on isolated aortic valve replacements with either homograft or autograft valves over a 15 year period.


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