Percutaneous paravalvular leak closure for symptomatic aortic regurgitation after CoreValve transcatheter aortic valve implantation

2014 ◽  
Vol 85 (4) ◽  
pp. 657-664 ◽  
Author(s):  
Satpal S. Arri ◽  
P. Poliacikova ◽  
D. Hildick-Smith
Author(s):  
Helge Möllmann ◽  
David M. Holzhey ◽  
Michael Hilker ◽  
Stefan Toggweiler ◽  
Ulrich Schäfer ◽  
...  

Abstract Background Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve. Methods The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months. Results The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL. Conclusions One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve. Graphic Abstract


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Kofler ◽  
A Unbehaun ◽  
S Buz ◽  
C Klein ◽  
A Meyer ◽  
...  

Abstract Background/Introduction Long-term continuous flow left ventricular assist device (cf-LVAD) can result in the development of relevant aortic regurgitation (AR). Although its impact on survival is still controversial, it causes heart failure related symptoms. Current evidence for less invasive strategies to treat AR in cf-LVAD patients is limited. Purpose This study sought to investigate the value of transcatheter aortic valve implantation (TAVI) to treat severe de novo AR in patients on long-term cf-LVAD support. Methods We performed a retrospective analysis of 13 patients with severe AR following cf-LVAD implantation treated with TAVI between 2010 and 2019. TAVI's were performed via transfemoral (n=11), transapical (n=1) and transaxillary (n=1) access route. CoreValve (n=2), LotusValve (n=1), SapienXT (n=1) and Sapien3 (n=9) were used as transcatheter heart valves. In 4 patients, a new off-label strategy using landing-zone pre-stenting with a Sinus-XL stent was used (Figure 1). Results The median time interval from LVAD-implantation to TAVI was 1.7 years [interquartile range (IQR): 1.0 - 3.1]. Median age was 62 years [IQR: 57 - 67]. No procedural mortality or stroke was observed. Overall, device success according to VARC-II criteria was low due to a high rate of second valve necessity (54%). In contrast to the standard implantation technique, device success was 100% when the newly developed pre-stenting technique was applied (Table 1). Aortic regurgitation at discharge was none/trace in all patients. Valve function remained stable in all patients during a median echocardiographic follow-up time of 105 days [IQR: 11 - 298]. Table 1 Overall Sinus-XL prestenting (n=4) NO prestenting (n=9) Device success 7 (54) 4 (100) 3 (33) Procedural mortality 0 (0) 0 (0) 0 (0) Correct positioning of a single valve 7 (54) 4 (100) 3 (33) Intended valve performance 13 (100) 4 (100) 9 (100) Moderate or severe aortic regurgitation 0 (0) 0 (0) 0 (0) Figure 1 Conclusions Transcatheter aortic valve implantation is an efficient tool to treat cf-LVAD induced severe AR. The challenging anatomy of the non-calcified device landing zone causes a relatively high rate of primary device failure, which could be overcome with a pre-stenting technique. Acknowledgement/Funding None


2014 ◽  
Vol 7 (3) ◽  
pp. 284-292 ◽  
Author(s):  
Mohamed Abdel-Wahab ◽  
Thomas Comberg ◽  
Heinz Joachim Büttner ◽  
Mohamed El-Mawardy ◽  
Kenichi Chatani ◽  
...  

2012 ◽  
Vol 59 (13) ◽  
pp. 1134-1141 ◽  
Author(s):  
Jan-Malte Sinning ◽  
Christoph Hammerstingl ◽  
Mariuca Vasa-Nicotera ◽  
Viktoria Adenauer ◽  
Sisa Josefina Lema Cachiguango ◽  
...  

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