Elsevier

International Journal of Cardiology

Volume 290, 1 September 2019, Pages 45-51
International Journal of Cardiology

Long-term outcomes with balloon-expandable and self-expandable prostheses in patients undergoing transfemoral transcatheter aortic valve implantation for severe aortic stenosis

https://doi.org/10.1016/j.ijcard.2019.03.050Get rights and content

Highlights

  • The occurrence of structural valve deterioration (SVD) is rare (<2%).

  • SVD is diagnosed on average 3.5 years after the index procedure.

  • Comparing valve-types, no differences in all-cause mortality or stroke can be seen.

  • Repeat interventions for prosthetic heart valve related problems occur sporadically.

Abstract

Background

Data on long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) is scarce.

Methods

We investigated long term outcomes of consecutive patients undergoing TAVI with balloon- and self-expandable bioprostheses (Edwards SAPIEN (ESV), Edwards Lifesciences Inc., Irvine, CA, USA; Medtronic Corevalve system (MCS), Medtronic Inc., Minneapolis, MN, USA).

Results

Among 628 patients (mean age 82.4 ± 5.8 years, 55% female), 489 (77.8%) underwent transfemoral TAVI. 309 (63.2%) patients received a MCS prosthesis, whereas 180 (36.8%) patients were treated with an ESV prosthesis. The median duration of follow-up amounted to 5.2 years (range 3.4–8.3 years). All-cause mortality did not differ between the two groups (MCS 46.9%, ESV 53.4%, CI 95%: RR 1.21 [0.93–1.57], P = 0.15), whereas cardiac mortality was higher in the ESV cohort after 5 years of follow-up (MCS 35.1%, ESV 45.4%, CI 95%: RR 1.37 [1.01–1.86], P = 0.04). Structural valve deterioration, which was on average diagnosed 41.9 months (range 18–60 months) after TAVI, occurred in 8 cases (1.6%), resulting in one repeat intervention.

Conclusions

While half of all patients died within 5 years after TAVI with no significant differences in all-cause mortality, structural valve deterioration was documented in <2% of cases.

Introduction

Transcatheter aortic valve implantations (TAVI) are rapidly expanding towards the low risk spectrum of patients with severe aortic stenosis. Randomized controlled trials showed comparable safety and efficacy of both, self- and balloon-expandable prostheses, as compared to surgical aortic valve replacement [[1], [2], [3]]. Regarding the use of TAVI in younger patients, the question of long-term outcomes and in particular of valve durability becomes of major importance. However, there is a significant lack of data regarding these factors, which can also be seen as directories regarding the decision making in favor of TAVI or surgical aortic valve replacement (SAVR) in patients with a lower operative risk profile. The aim of the present analysis was to evaluate the long-term outcomes regarding the performance of the two most widely used TAVR systems: the balloon-expandable Edwards SAPIEN valve (ESV) (Edwards Lifescience Inc., Irvine, CA, USA) and the self-expandable Medtronic Corevalve system (MCS) (Medtronic Inc., Minneapolis, MN, USA) in patients undergoing TAVI for severe symptomatic aortic valve stenosis.

Section snippets

Study population

Between July 2007 and January 2013, all patients undergoing TAVI at the Swiss Cardiovascular Center of Bern University Hospital in Switzerland were consecutively recorded in a prospective registry held at the Clinical Trials Unit of the University of Bern in Switzerland. Inclusion criteria consisted of a) symptomatic, severe aortic stenosis (AS) with an echocardiographic mean gradient >40 mm Hg or a calculated aortic valve area < 1 cm2 and b) age ≥ 80 years with a high operative risk score

Results

Among 628 patients (mean age 82.4 ± 5.8 years, 54.6% female), 489 patients (77.8%) underwent transfemoral TAVI for native aortic valve stenosis. Patients undergoing transapical (N = 124, 19.7%) or trans-subclavian (N = 9, 1.4%) TAVI, as well as patients with a transcatheter-valve-in-surgical-valve procedure (N = 6, 1%) were excluded from the present analysis. 309 (63.2%) patients were treated with a MCS whereas 180 (36.8%) patients received an ESV (ESV THV in 27 (5.5%) cases, ESV XT in 153

Discussion

We present long-term clinical outcomes of patients with a symptomatic severe AS treated with transfemoral TAVI using either a balloon-expandable (ESV) or a self-expandable (MCS) prosthesis. The key findings can be summarized as follows: (1) >50% of patients died within 5 years after TAVI; there were no differences in all-cause mortality and major stroke between patients treated with either a balloon-expandable ESV or a self-expandable MCS prosthesis; (2) Structural valve deterioration occurred

Conclusion

More than 50% of patients undergoing TAVI died within 5 years of the procedure with no significant differences in all-cause mortality between MCS and ESV. Structural valve deterioration was documented in <2% of patients.

The following are the supplementary data related to this article.

. Degree of aortic regurgitation pre-treatment, post-treatment, and during follow-up times of 1, 3, and 5 years.

. Changes in aortic regurgitation (AR) before and after treatment.

Acknowledgement of grant support

N/A.

Potential conflicts of interest

Peter Wenaweser received lecture and proctoring fees from Medtronic, Edwards Lifesciences, and Boston Scientific. Fabien Praz received proctoring fees of Edwards Lifesciences. Stephan Windecker received research grants to the institution from Abbott, Amgen, Biotronik, Boston Scientific, St Jude Medical, Terumo and Bayer. Thomas Pilgrim received research grants to the institution from Symetis/Boston Scientific, Edwards Lifesciences, and Biotronik and received speaker fees from Boston Scientific

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