Long-term outcomes with balloon-expandable and self-expandable prostheses in patients undergoing transfemoral transcatheter aortic valve implantation for severe aortic stenosis☆
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.
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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
References (42)
- et al.
Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis
Lancet
(2016) - et al.
Clinical outcome and predictors for adverse events after transcatheter aortic valve implantation with the use of different devices and access routes
Am. Heart J.
(2011) - et al.
Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document
J. Am. Coll. Cardiol.
(2012) - et al.
Outcomes after transthoracic, peripheral vascular and transfemoral transcatheter aortic valve implantation: a propensity analysis from France TAVI Registry
J. Am. Coll. Cardiol.
(2018) - et al.
Transcatheter aortic valve implantation with the Edwards SAPIEN versus the Medtronic CoreValve Revalving system devices: a multicenter collaborative study: the PRAGMATIC Plus Initiative (Pooled-RotterdAm-Milano-Toulouse In Collaboration)
J. Am. Coll. Cardiol.
(2013) - et al.
Predictors for permanent pacemaker requirement after transcatheter aortic valve implantation with the CoreValve bioprosthesis
Am. Heart J.
(2009) - et al.
Factors associated with cardiac conduction disorders and permanent pacemaker implantation after percutaneous aortic valve implantation with the CoreValve prosthesis
Am. Heart J.
(2010) - et al.
Impact of permanent pacemaker implantation on clinical outcome among patients undergoing transcatheter aortic valve implantation
J. Am. Coll. Cardiol.
(2012) - et al.
Optimal implantation depth and adherence to guidelines on permanent pacing to improve the results of transcatheter aortic valve replacement with the Medtronic CoreValve system: the CoreValve prospective, international, post-market ADVANCE-II study
J. Am. Coll. Cardiol. Intv.
(2015) - et al.
Determinants of significant paravalvular regurgitation after transcatheter aortic valve implantation: impact of device and annulus discongruence
J. Am. Coll. Cardiol. Intv.
(2009)
Comparison of the hemodynamic performance of percutaneous and surgical bioprostheses for the treatment of severe aortic stenosis
J. Am. Coll. Cardiol.
1-Year outcomes after transcatheter aortic valve replacement with balloon-expandable versus self-expandable valves: results from the CHOICE randomized clinical trial
J. Am. Coll. Cardiol.
3-Year outcomes in high-risk patients who underwent surgical or transcatheter aortic valve replacement
J. Am. Coll. Cardiol.
5-Year outcomes after transcatheter aortic valve implantation with CoreValve prosthesis
JACC Cardiovasc. Interv.
5-Year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial
Lancet
Late outcomes of transcatheter aortic valve replacement in high-risk patients: the FRANCE-2 registry
J. Am. Coll. Cardiol.
5-Year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial
Lancet.
Long-term outcomes after transcatheter aortic valve implantation: insights on prognostic factors and valve durability from the Canadian multicenter experience
J. Am. Coll. Cardiol.
Carpentier-Edwards pericardial bioprosthesis in aortic or mitral position: a 12-year experience
Ann. Thorac. Surg.
A 20-year experience of 1712 patients with the Biocor porcine bioprosthesis
J. Thorac. Cardiovasc. Surg.
Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study
Lancet
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