麻豆传媒

SAN DIEGO -- New transcatheter aortic valve replacement (TAVR) systems are showing good safety and effectiveness data in findings reported here at the (TCT) annual meeting.

The new Portico transcatheter heart valve (THV) system led to low 1-year mortality and stroke rates among patients with increased surgical mortality risk in a prospective, single-arm, non-randomized, multicenter study.

The primary endpoint showed a 1-year Kaplan-Meier estimate of 12.1% for all-cause mortality, Lars Søndergaard, MD, DMSc, of the University of Copenhagen, reported at the meeting and online in the .

"These rates compare well with those reported from smaller series with the self-expanding, repositionable valve and larger studies with the CoreValve and Sapien 3 THV systems in comparable cohorts," the researchers wrote.

"Clinical benefit is also demonstrated through an observed improvement in functional class, exercise capacity, and quality of life," the investigators wrote.

The Portico valve is currently being tested in the United States in a randomized trial, pointed out late-breaking session panel discussant David Cohen, MD, MSc, of Saint Luke's Health System in Kansas City, Missouri.

These study findings "show how hard its going to be to make any heads or tails out of either cross-study or even observational comparisons of these devices," Cohen said.

"They are just being used in different patients, in different ways and being selected based on perceived advantages for one feature or another," he continued.

The investigators evaluated 941 patients (average age 82.4 and 65.7% female), all of whom underwent TAVR with the new THV at one of 61 sites in Australia, Canada, and Europe.

The secondary outcomes at 1-year follow-up were Kaplan Meier estimates of 6.6% for cardiovascular mortality, 2.2% for disabling stroke rates, and 2.5% for myocardial infarction.

Søndergaard and co-authors acknowledged the limitations of their findings in that the study was real-world post-approval in those countries and was non-randomized. Patient selection may have included some bias as well, they noted.

Another limitation was that centers had a range of patient loads and experience, which in conjunction with the new THV system contributed to a learning curve for the centers.

In a second study, the Acurate neo and Evolut PRO for transfemoral TAVR resulted in high device success rates and good outcomes in terms of paravalvular aortic regurgitation (PAR) and 30-day clinical outcomes, a multicenter, observational, retrospective study found.

Overall, the primary endpoint of device success by Valve Academic Research Consortium (VARC-2) criteria was 92.0% for Acurate neo and 90.7% for Evolut PRO (P=0.539), Azeem Latib, of San Raffaele Scientific Institute in Milan, Italy, reported at the meeting.

That VARC-2 composite endpoints comprises no procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, and intended performance of the prosthetic heart valve without prosthesis–patient mismatch or moderate or severe prosthetic valve regurgitation and mean aortic valve gradient <20 mm Hg or peak velocity <3 m/s.

The investigators evaluated 1,551 patients (1,263 Acurate neo and 288 Evolut PRO), all of whom were treated at one of 24 centers.

The moderate-to-severe PAR findings were 5.2% for the Acurate neo patients and 5.7% for the Evolut PRO patients (P=0.659).

The 30-day clinical outcomes, based on VARC-2 criteria, were as follows, when comparing Acurate neo patients versus Evolut PRO patients:

• All cause mortality: (3.0% versus 1.8%; P=0.319)
• Cardiovascular morality:(2.3% versus 1.1%; P=0.249)
• Any stroke: (2.0% versus 2.5%; P=0.645)
• Any bleeding: (14.9% versus 8.5%; P=0.004)
• Any vascular complication: (17.1% versus 11.6%; P=0.025)
• Coronary obstruction: (0.2% versus 0.4%; P=0.562)
• New permanent pacemaker implantation (PPI): (8.8% versus 13.2%; P=0.045)
• VARC-2 safety composite endpoint: (16.4% versus 10.9%; P=0.025)

The propensity matched 30-day clinical outcomes were as follows, when comparing Acurate neo patients versus Evolut PRO patients:

• All cause mortality: (3.2% versus 1.2%; P=0.221)
• Cardiovascular mortality: (2.4% versus 0.4%; P=0.122)
• Any stroke: (2.4% versus 2.8%; P=1.000)
• Any bleeding: (13.0% versus 8.4%; P=0.112)
• Any vascular complication (14.2% versus 11.7%; P=0.424)
• Coronary obstruction (0.0% versus 0.0%)
• New PPI: (11.0% versus 12.8%; P=0.565)
• VARC-2 safety composite endpoint: (10.6% versus 10.4%; P=1.00)

The moderate to severe PAR is a little more than expected across the board, but these are very challenging cases, explained Sameer Gafoor, MD, of CardioVascular Center in Frankfurt, Germany.

The study had limitations, the investigators noted. Some of those limitations included that there was no core-laboratory analysis, no independent adjudication of clinical events, and "the potential impact of unknown/unmeasured confounding factors on outcomes," the researchers emphasized.

"I think you did a nice job, the match looked pretty tight. You shouldn't view the small number of match patients as a limitation," Neal Kleiman, MD, of Houston Methodist in Texas, said to Søndergaard during a panel discussion at TCT.

The investigators concluded that "after adjustment for potential confounders, short-term outcomes were similar between both devices."

Comment