乌鸦传媒視頻

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SAN FRANCISCO -- Tip-top technique was important for longer-term survival after transcatheter aortic valve replacement (TAVR), a procedure that was also shown to give patients better health status than surgery at the 1-year mark, PARTNER investigators reported.

Sapien XT and Sapien 3, two balloon-expandable transcatheter aortic valves, were tested in intermediate and low surgical risk populations for the treatment of severe aortic stenosis. The latest findings were presented at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting.

PARTNER 2A at 5 Years

TAVR patients at intermediate surgical risk had an excess in rehospitalizations and valve reinterventions since the 2-year PARTNER 2A report in 2016, according to a late-breaking trial at TCT.

The primary endpoint of death from any cause or disabling stroke over 5 years was numerically, but not significantly, higher for people randomized to Sapien XT TAVR versus surgery in the trial (47.9% vs 43.4%, HR 1.09, 95% CI 0.95-1.25), according to Vinod H. Thourani, MD, of MedStar Heart & Vascular Institute in Washington.

A landmark analysis revealed more frequent events starting 2 years after TAVR (HR 1.27, 95% CI 1.06-1.53) whether the procedure was done via transfemoral (HR 1.23, 95% CI 1.00-1.52) or, even worse, transthoracic access (HR 1.45, 95% CI 1.01-2.07), according to Thourani.

TAVR was associated with increased mild, moderate, and severe paravalvular regurgitation (PVR) compared with surgery, he noted. It was moderate-severe PVR, but not mild PVR, that was associated with increased late mortality.

Thus, the best survival was seen for patients who had been left with none-or-trace PVR after transfemoral TAVR, a group that had no more death or disabling strokes than the surgical aortic valve replacement (SAVR) arm in the 2-year landmark analysis (32.4% vs 28.9%, HR 1.11, 95% CI 0.87-1.42), Thourani said.

"We are learning that [PVR], no matter what valve, is a bad idea," he said. "No matter what you're using, you have to decrease PVR. Don't let them [patients] sit; it affects ejection fraction. You need to go fix it with another valve ... That's the big message that comes out of this study."

In today's low-risk TAVR era, the troubling thing is that mild PVR is about 15 times more common after TAVR than with surgery and almost reached statistical significance in its association with excess mortality compared with none-trace PVR, according to Michael Borger, MD, PhD, of New York-Presbyterian/Columbia University Medical Center in New York City.

Sharing that concern was Martin Leon, MD, also of New York-Presbyterian/Columbia University Medical Center, who suggested that even mild PVR should be eliminated as much as possible given that its long-term consequences are unknown. Leon is a leader of the PARTNER trials.

investigators had previously concluded that TAVR was non-inferior to surgery for intermediate-risk patients based on 2-year data and a 2,032-person cohort.

The new findings support continued follow-up of patients at later timepoints such that follow-up has been extended to 10 years in PARTNER 2A, he noted.

Going against TAVR were rates of rehospitalization (33.3% vs 25.2%, HR 1.28, 95% CI 1.07-1.53) and freedom from aortic valve reintervention (96.8% vs 99.4%, HR 3.93, 95% CI 1.48-10.43) in the mid-term. However, this group did exhibit less post-operative atrial fibrillation (HR 0.43, 95% CI 0.35-0.53).

Valve hemodynamics indicated no important hemodynamic differences between TAVR or surgical bioprosthetic valves.

TAVR and surgery both improved cardiac symptoms and quality-of-life measures, and these favorable changes were sustained at 5 years, Thourani reported.

Yet follow-up data out to 5 years were available for 90.9% of TAVR arm and 81.4% of those who underwent surgery. "Missing data at 5 years, especially in the surgical patients, for some of the clinical and [echocardiography] endpoints reduces the rigor of conclusions," the investigator cautioned.

Another limitation is that the Sapien XT is no longer in use in the U.S.

The mortality result for TAVR might have been better if this were a Sapien 3 trial, suggested TCT panelist Stuart Pocock, MSc, PhD, of the London School of Hygiene and Tropical Medicine. "The bad news is that will never happen."

PARTNER 3 Health Status

Although health status improved after both TAVR and SAVR, the former was associated with greater heart failure-specific benefits at 1 year in low-risk patients, research showed at a separate TCT session. Results were published in the Journal of the American College of Cardiology.

Overall summary scores on the heart failure-specific Kansas City Cardiomyopathy Questionnaire (KCCQ) favored TAVR 1 month later (16.0 points better than surgery, P<0.001). The advantage was maintained out to 12 months but had narrowed to 1.8 points (P=0.03).

An early advantage in SF-36 physical and mental summary scores had disappeared by year's end, however, according to Suzanne Baron, MD, MSc, of Lahey Hospital and Medical Center in Burlington, Massachusetts, and Saint Luke's Mid America Heart Institute in Kansas City, Missouri.

Baron argued that the KCCQ is better at capturing meaningful differences in health outcome in heart failure. The 1.8-point difference between groups may be numerically small, but it was driven by a subset of patients that had large 20-35 point improvements.

Moreover, a categorical analysis combining survival and KCCQ handed TAVR the advantage over surgery at 1, 6, and 12 months.

"Taken together with the clinical outcomes of the PARTNER 3 trial, these findings further support the use of TAVR in patients with severe AS [aortic stenosis] at low surgical risk," she concluded. "Longer term follow-up is necessary, and ongoing, to determine whether the health status benefits of TAVR at 1 year are durable."

The latest quality-of-life findings "reinforce" the primary analysis of PARTNER 3, commented Philippe Genereux, MD, of Morristown Medical Center, a co-investigator of the trial, during a TCT press conference.

Transfemoral TAVR with the Sapien 3 had been found superior than surgery at 1 year -- producing fewer deaths, strokes, and rehospitalizations -- in the PARTNER 3 report from March. There were 1,000 patients at low surgical risk randomized for the trial.

Those who started out with the worst functional impairment at baseline (New York Heart Association Class III and IV symptoms) demonstrated the greatest KCCQ improvement, Baron reported.

"Exploratory analyses suggest that differences in peri-procedural complication rates also accounted for a modest proportion of the late health status benefits associated with TAVR," she said. When 30-day complications were added to the analysis, the 1.8-point predicted difference in KCCQ overall summary score was reduced to 1.3 points and no longer significant.

These results may not be generalizable to TAVR with other devices, access routes, and excluded patient populations, she acknowledged.

Also, frail patients were not included in PARTNER 3, pointed out Suzanne Arnold, MD, of Saint Luke's Hospital in Kansas City, Missouri, during the TCT press conference.