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Late-breaking abstract presentations reveal new information on TAVI

ESC Congress News 2018 - Munich, Germany

Transcatheter aortic valve implantation (TAVI), or transcatheter aortic valve replacement (TAVR), is an established treatment for patients with severe aortic stenosis considered to be at high risk for surgical valve replacement. A number of late-breaking TAVI registry abstract presentations yesterday provided long-term data in high-risk patients and data on the use of this approach in lower-risk patients.

Aortic Disease
Interventional Cardiology and Cardiovascular Surgery
Valvular Heart Disease


Professor Martine Gilard (Hospital Cavale Blanche, Brest, France) reported 5-year follow-up data from the FRANCE-2 registry, which included all consecutive high-risk patients (n=4,201) who underwent a CoreValve or Edwards TAVI procedure at 34 centres in France between January 2010 and January 2012.(1)

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“At five years, the all-cause mortality rate was 60.8%,” she notes. “Most cardiovascular events occurred within the month after valve implantation, remaining low (<2%/year) thereafter. The exception was heart failure, which decreased over time to <5%/year from 14.3% at one year.” In terms of the valve, the mean gradient, valve area and aortic valve regurgitations remained stable over time. “We found that moderate haemodynamic structural valve deterioration (SVD) increased from 6.9% at one year to 13.3% at five years, but that it was severe in only 1.4% and 2.5% of cases, respectively,” she says.

The data from FRANCE-2 represent the largest long-term dataset available for TAVI in a high-risk population and support the long-term efficacy of the approach in this population.

“The FRANCE-2 registry is the largest cohort of consecutive TAVI patients with available late follow-up, and with 459 patients having echocardiographic evaluation at five years providing unique information with regard to valve durability,” says Prof. Gilard. “Haemodynamic SVD was defined according to the European Association of Percutaneous Cardiovascular Interventions (EAPCI) consensus statement. The low rates of severe haemodynamic SVD and good New York Heart Association (NYHA) functional status maintained up to five years support the long-term efficacy of TAVI with the two types of transcatheter prostheses used in these in high-risk patients.”

Although TAVI is a standard approach for high-risk patients, interest in this treatment option for lower-risk patients is growing. Two registries reported on its use in this patient type.

Professor Raffi Bekeredjian (Robert-Bosch Hospital, Stuttgart, Germany) presented results of an analysis of the German Aortic Valve Registry (GARY), comprising patients with a Society of Thoracic Surgeons’ (STS) risk score of <4%, comparing patients undergoing isolated TAVI (n=6,062) with those receiving surgical aortic valve replacement (SAVR; n=14,487) between 2014 and 2015. “While all patients had an STS score of <4%, the two treatment groups differed significantly in their baseline characteristics. For example, TAVI patients were older (79 vs 67 years, p<0.0001) and had a higher mean STS score (2.86 vs 1.79, p<0.0001) and European System for Cardiac Operative Risk Evaluation score (EuroSCORE) (12.9 vs 5.9, p<0.0001). There are no guidelines recommending TAVI as a treatment for low-risk patients and these differences at least partly reflect the heart teams’ decisions in selecting the patients most suitable for TAVI.”

Short-term survival rates were higher with TAVI than SAVR, but there was no difference between the groups in the number of patients surviving at one year.

“Using a weighted propensity score model, the survival rates for TAVI and SAVR were 98% vs 97%, for both the in-hospital (p=0.003) and 30-day (p=0.014) time periods,” says Prof. Bekeredjian. “The 12-month survival rates were 90% with TAVI and 91% with SAVR (p=0.158), showing non-inferiority.” This pattern was consistent for transvascular TAVI.

“The results from GARY,” he says, “provide convincing evidence to support the benefits of TAVI in low-risk patients.”

The Low Risk TAVR (LRT) trial is the first FDA-approved, prospective, multicentre clinical trial of TAVI in low-risk patients in the USA.(2) “The study investigated the safety and feasibility of TAVR in 200 elderly patients with an STS score ≤3%, using all-cause mortality as the primary endpoint,” says Professor Ron Waksman (MedStar Washington Hospital Center, Washington DC, USA). “As would be expected, these low-risk patients, who had a ≤3% 30-day STS-predicted risk of mortality, were younger than those observed in previous intermediate-risk studies, with a mean age of 73.8 years,” he says. The 30-day clinical outcomes support the safety and efficacy of TAVI in low-risk patients. “All-cause mortality was 0% at 30 days,” says Prof. Waksman, “and rates of secondary Valve Academic Research Consortium (VARC)-2 safety signals were low. Among 194 patients available for subclinical leaflet thrombosis assessment, hypoattenuated leaflet thickening was observed in 15.8% taking antiplatelet therapy and 7.7% receiving anticoagulants.”

Patients in the LRT trial underwent a propensity score-matched comparison with a historical control of 719 patients who underwent SAVR at the same institutions between January 1 2013 and December 31 2017. The primary endpoint was all-cause mortality at 30 days. “The zero 30-day all-cause mortality in the TAVR group compared with 1.7% mortality in the SAVR group,” comments Prof. Waksman, continuing, “Also, there were zero in-hospital strokes in the TAVR group vs 0.6% stroke in the SAVR group.” Permanent pacemaker implantation rates were similar between TAVI and SAVR patients (5.0% vs 4.5%). The rate of new onset atrial fibrillation (3.0%) and length of hospital stay (2.0±1.1 days) were low in the TAVI group. One TAVI patient had mild paravalvular leak and 14% of TAVI patients had evidence of subclinical leaflet thrombosis at 30 days.

"The results of LRT are a strong signal that expansion of the indication of TAVR for low-risk patients is just a matter of time,” concludes Prof. Waksman.

1. Didier R, et al. Circulation 2018;August 28:doi:10.1161/CirculationAHA.118.036866.
2. Waksman R, et al. J Am Coll Cardiol 2018;doi:10.1016/j.jacc.2018.08.1033.

 

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Notes to editor

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