5-Year Outcomes After TAVR With CoreValve

Study Questions:

What are the 5-year outcomes associated with transcatheter aortic valve replacement (TAVR) using the self-expanding CoreValve prosthesis?

Methods:

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

Results:

All-cause mortality rates at 1, 2, 3, 4, and 5 years were 21%, 29%, 38%, 48%, and 55%, respectively; cardiovascular mortality rates were 10%, 14%, 19%, 23%, and 28%, 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 re-hospitalizations for cardiovascular reasons in 164 (46%) patients. Among all re-hospitalizations, 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-TAVR) to 12.8 ± 10.9 mm Hg (5-years post-TAVR) (p < 0.001). Late prosthesis failure occurred in five cases (1.4%); among these, redo TAVR was successfully carried out in two patients (0.6%) presenting with symptomatic prosthesis restenosis. The remaining three cases of prosthesis failure did not undergo further invasive interventions. Ten patients (2.8%) had evidence of 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:

TAVR with the third-generation CoreValve was associated with sustained clinical outcomes up to 5 years post-procedure, with a low rate (1.4%) of significant prosthetic valve degeneration. The procedure appears to be an adequate and durable treatment for aortic stenosis in selected high-risk patients.

Perspective:

Data from this multicenter Italian registry support favorable and durable (to 5 years) outcomes following TAVR with the CoreValve device. Patients were 81.5 ± 6.3 years of age at the time of intervention. As TAVR is being used in progressively lower-risk patients, independent assessment of outcomes (and especially durability in younger patients) will be of interest.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound

Keywords: Aortic Valve Stenosis, Cardiovascular Surgical Procedures, Constriction, Pathologic, Echocardiography, Heart Failure, Heart Valve Diseases, Prosthesis Failure, Prostheses and Implants, Thrombosis, Transcatheter Aortic Valve Replacement


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