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JACC Cardiovasc Interv. 2015 Jul;8(8):1084-1091. doi: 10.1016/j.jcin.2015.03.024. Epub 2015 Jun 24.

5-Year Outcomes After Transcatheter Aortic Valve Implantation With CoreValve Prosthesis.

Author information

1
Ferrarotto Hospital, University of Catania, Catania, Italy; ETNA Foundation, Catania, Italy. Electronic address: mbarbanti83@gmail.com.
2
AOU Pisana, Pisa, Italy.
3
Spedali Civili, Brescia, Italy.
4
Scientific Institute S. Raffaele, Milan, Italy.
5
Clinical Institute S. Ambrogio, Milan, Italy.
6
Niguarda Ca'Granda Hospital, Milan, Italy.
7
Ospedale Civile, Legnano, Italy.
8
Azienda ASL S. Camillo Forlanini, Rome.
9
Ferrarotto Hospital, University of Catania, Catania, Italy; ETNA Foundation, Catania, Italy.
10
Ferrarotto Hospital, University of Catania, Catania, Italy.
11
Quinario SA, Biostatistics Consultancy, Lugano, Switzerland.

Abstract

OBJECTIVES:

The purpose of this analysis was to assess 5-year outcomes of transcatheter aortic valve implantation (TAVI) using the current technology of the self-expanding CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota).

BACKGROUND:

There is a paucity of evidence on long-term durability of currently available transcatheter heart valves.

METHODS:

Starting in June 2007, all consecutive patients with severe aortic stenosis undergoing TAVI with the third-generation 18-F CoreValve device in 8 Italian centers were prospectively included in the ClinicalService Project. For the purposes of this study, we included only consecutive patients with 5-year follow-up data available (n = 353) treated from June 2007 to August 2009. All outcomes were reported according to VARC (Valve Academic Research Consortium)-1 criteria.

RESULTS:

All-cause mortality rates at 1, 2, 3, 4, and 5 years were 21%, 29%, 38%, 48%, and 55.0%, respectively. Cardiovascular mortality rates at 1, 2, 3, 4, and 5 years were 10%, 14%, 19%, 23%, and 28.0%, respectively. The overall neurological event rate at 5 years was 7.5%, of which more than two-thirds occurred early after the procedure. During follow-up, there were 241 rehospitalizations for cardiovascular reasons in 164 (46%) patients. Among all rehospitalizations, acute heart failure was the most frequently reported (42.7%), followed by requirement of permanent pacemaker implantation (17.4%). On echocardiography, mean transaortic gradients decreased from 55.6 ± 16.8 mm Hg (pre-TAVI) to 12.8 ± 10.9 mm Hg (5-year post-TAVI) (p < 0.001). Late prosthesis failure occurred in 5 cases (1.4%); among these, redo TAVI was successfully carried out in 2 patients (0.6%) presenting with symptomatic prosthesis restenosis. The remaining 3 cases of prosthesis failure did not undergo further invasive interventions. Ten patients (2.8%) showed late mild stenosis with a mean transaortic gradient ranging from 20 to 40 mm Hg. No other cases of structural or nonstructural valvular deterioration were observed. Valve thrombosis or late valve embolization were not reported.

CONCLUSIONS:

TAVI with the currently adopted CoreValve generation was associated with sustained clinical outcomes up to 5-year follow-up, with a low rate (1.4%) of significant prosthetic valve degeneration. The procedure appears to be an adequate and lasting resolution of aortic stenosis in selected high-risk patients.

KEYWORDS:

TAVI; long-term outcomes; prosthetic valve failure

PMID:
26117458
DOI:
10.1016/j.jcin.2015.03.024
[Indexed for MEDLINE]
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