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Self-expanding TAVR system confers positive outcomes in real-world cohorts

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In two real-world patient populations, a self-expanding transcatheter aortic valve replacement system was associated with positive outcomes, including symptomatic and hemodynamic improvement, according to presentations at EuroPCR.

In the ADVANCE study, an early version of the TAVR system (CoreValve, Medtronic) conferred hemodynamic and symptomatic improvements in 465 high-risk patients with severe symptomatic aortic stenosis at 5 years. In the FORWARD study, a newer-generation system (CoreValve Evolut R, Medtronic) was associated with a high survival rate, a low rate of disabling stroke and good hemodynamic performance in 1,038 patients at 30 days.

ADVANCE

In ADVANCE, presented by Ulrich Gerckens, MD, from HELIOS Heart Center Siegburg, Germany, the 5-year survival rate was 50.7% (95% CI, 46.7-54.5), which is comparable to 5-year results from other TAVR studies, Medtronic stated in a press release.

Other 5-year clinical outcomes included a CV mortality rate of 33.5% (95% CI, 29.3-37.8), a 51.8% rate of all-cause mortality or major stroke (95% CI, 47.9-55.6), a 10.2% rate of stroke (95% CI, 7.2-13.7), a 5.4% rate of major stroke (95% CI, 3.3-8.2), a 3.7% rate of MI (95% CI, 2-6.1), a 33.7% rate of new pacemaker implantation (95% CI, 28.4-39), a 2.8% rate of emergent cardiac surgery or percutaneous reintervention (95% CI, 1.4-5), a 14.2% rate of major bleeding (95% CI, 10.7-18.2) and a 55.8% rate of MACCE (95% CI, 51.9-59.5).

Predictors of 5-year mortality included age (HR = 1.03, 95% CI, 1.01-1.05), peripheral vascular disease (HR = 1.43; 95% CI, 1.11-1.84), chronic obstructive pulmonary disease (HR = 1.32; 95% CI, 1.03-1.7), creatinine (HR = 1.22; 95% CI, 1.11-1.35), baseline left ventricular ejection fraction 50% (HR = 1.37; 95% CI, 1.11-1.69), baseline mean gradient (HR = 0.99; 95% CI, 0.98-1), major bleeding (HR = 1.58; 95% CI, 1.19-2.09) and acute kidney injury (HR = 14.31; 95% CI, 5.72-35.79).

NYHA class improved from 65.6% class III and 8.4% class IV at baseline to 18.1% class III and 0.9% class IV at 5 years, according to the researchers.

Effective orifice area rose from 0.7 cm² at baseline to 1.7 cm² at 5 years, whereas mean gradient declined from 45.6 mm Hg at baseline to 8.8 mm Hg at 5 years.

“This is excellent news,” investigator Eberhard Grube, MD, FACC, FSCAI, professor of cardiology and head of the Center of Innovative Interventions at University Hospital Bonn, Germany, told Cardiology Today’s Intervention. “We have evidence for good functioning out to 5 years with that first-generation device.”

FORWARD

For the FORWARD study, presented by Grube, researchers evaluated the newest-generation self-expanding valve in real-world patients (mean age, 82 years; 65% women) with a mean Society of Thoracic Surgeons predicted risk of mortality (PROM) score of 5.5%.

The primary endpoint of 30-day mortality occurred in 1.9% of patients (95% CI, 1.2-3), lower than the predicted 5.5%.

At 30 days, effective orifice area increased from 0.8 cm² to 1.9 cm², and mean gradient declined from 41.7 mm Hg to 8.5 mm Hg (P < .001 for both), Grube said.

At discharge, paravalvular leak was moderate in 1.9% of the cohort and severe in 0.1%, whereas all aortic regurgitation was moderate in 1.8% and severe in 0.1%.

Stroke rates at 30 days were 2.8% for any stroke and 1.8% for disabling stroke, whereas major complications occurred in 6.5%, life-threatening or disabling bleeding occurred in 3.3% and new pacemaker implantation occurred in 17.5%.

NYHA functional class improved from 63.8% class III and 8.2% class IV at baseline to 11.3% class III and 0.7% class IV at 30 days, Grube said.

Outcomes did not differ between those who had the valve repositioned during the procedure (n = 265) or not (n = 763), except for valve migration, which was 0.8% in the repositioned group and 0% in the nonrepositioned group (P = .02), Grube said.

“There was a question whether the repositioning feature would be reflected in stroke rates, and it came out very well between the two groups,” Grube told Cardiology Today’s Intervention. “This is a safe device and an effective device.” – by Erik Swain

References:

Gerckens U, et al.

Grube E, et al. TAVI registries and durability – Session comprising selected EuroPCR late-breaking trial submissions. Both presented at: EuroPCR; May 16-19, 2017; Paris.

Disclosure: The studies were funded by Medtronic. Gerckens reports receiving speakers’ honoraria from and proctoring for Edwards Lifesciences and Medtronic. Grube reports serving on advisory boards for Boston Scientific, LivaNova and Medtronic and proctoring for Boston Scientific and Medtronic.