PORTICO 1: Low 1-Year Mortality, Stroke With Repositionable Valve

Patrice Wendling

October 03, 2018

SAN DIEGO — The self-expanding, repositionable Portico (Abbott) transcatheter aortic valve was associated with low mortality and disabling stroke rates at 1 year in early commercial use outside the United States, according to results of the PORTICO 1 study.

Although 21.3% of patients required a pacemaker at 1 year, this is in line with pacemaker rates of 22.1% and 15.3% reported, respectively, for the newer-generation, self-expanding Evolut R (Medtronic) and Sapien 3 (Edwards Lifesciences) valves, said Lars Søndergaard, MD, DMSc, Rigshospitalet, Copenhagen.

The results were presented here at Transcatheter Cardiovascular Therapeutics 2018, and published online September 25 in the Journal of the American College of Cardiology.

During a discussion of the results, panelist Raj Makkar, MD, Cedars-Sinai Medical Center, Los Angeles, agreed that pacemaker rates are comparable in the registries, but asked what lessons can be learned from "a 20% pacemaker rate, as we talk about moving into lower-risk patients."

Søndergaard replied, "It's very important to have low pacemaker rates when we move down to younger patients with a longer life expectancy; I think it's not going to be as high as in the elderly patient."

He noted that the pacemaker rate in Copenhagen has gone from about 20% with the first cohort to about 10% as operators learned to reposition the Portis during transcatheter aortic valve replacement (TAVR).

"So for sure there is a learning curve and, importantly, pacemakers are also up against what we call this TAVR simplification," Søndergaard said. "We want to have this fast track for patients, but if there is a doubt or signs for a pacemaker early on, instead maybe just give it 1 or 2 days to see if the conduction abnormalities resolve."

PORTICO 1 is the first real-world, postmarketing study of the Portico valve, with positive 30-day results reported earlier this year at EuroPCR 2018.

The device has been available commercially in Europe for about 6 years, but it got off to a rocky start after implantations were put on "pause" worldwide in 2014 to allow then-device maker St. Jude Medical to evaluate cases of reduced valve leaflet mobility in the investigational device-exemption (IDE) trial in the United States.

PORTICO 1 prospectively enrolled 941 patients (mean age, 82 years) with severe, symptomatic aortic stenosis who were treated with Portico at 61 centers in Australia, Canada, and Europe and who were at moderate to high surgical risk. Follow-up was available for 828 patients at 30 days and 717 at 1 year. All four sizes of the stent were used (23 mm, 25 mm, 27 mm, and 29 mm), although the two larger sizes were available only after 2015, Søndergaard noted.

Two-thirds of patients were female, 64% were NYHA class III/IV, 85% fulfilled the criteria for frailty, 30% had diabetes, and the mean baseline Society of Thoracic Surgery score was 5.8.

The device was implanted in 96.0% of patients and was resheathed for repositioning in 41.4%. Predilatation was done in 89.0% of patients and postdilatation in 43.3%.

Rates of all-cause mortality were 2.7% at 30 days and 12.1% at 1 year; for cardiovascular mortality, they were 2.4% and 6.6%, respectively.

Disabling stroke occurred in 1.6% of patients at 30 days and 2.2% at 1 year, with nondisabling stroke or transient ischemic attack reported in 1.4% and 3.1% of patients, respectively.

In multivariate analysis, independent predictors of 1-year mortality were pre-existing kidney disease, heart failure, history of myocardial infarction, mitral regurgitation, NYHA class IV, and length of hospitalization after the index procedure, the authors note in the paper.

"The hemodynamic performance was excellent," said Søndergaard, with the mean aortic gradient improving from 49.7 mm Hg at baseline to 8.6 mm Hg at 30 days and 8.8 mm Hg at 1 year. The mean effective orifice area increased from 0.7 cm2 to 1.8 cm2 and 1.7 cm2 over the same period.

No patient had severe paravalvular leak (PVL) at 30 days or 1 year, but moderate PVL was present in 4.0% and 2.6% of patients, respectively.

Continuing the comparison with the other self-expanding devices, Søndergaard pointed out that rates of more than mild PVL at 1 year were 1.2% with Evolut R in the FORWARD study and 2.7% with Sapien 3 in the Source 3 study. Mean gradients at 1 year were 8.1 mm Hg and 12.3 mm Hg, respectively.

Finally, half of all patients treated with Portico improved by one NYHA functional class at 1 year ,and one in four patients improved by two functional classes.

Session moderator James B. Hermiller Jr., MD, St. Vincent Heart Center, Indianapolis, remarked during the discussion: "Despite it maybe not having quite the radial strength, the PVL was quite low."

Søndergaard responded vigorously: "The radial force of the Portico is exactly the same as it is for the Evolut, but it has a lower opening force and that's why it's recommended that if you have moderate to severe calcification, you do a predilatation.

In contrast, "you've got a system which is much more flexible. It's a very flexible cath so you can go around tortuous anatomy, acute dilation of the aortic arch, and you can work with the guidewire to make coaxial alignment if you have a horizontal aorta. So that's the trade-off between the two," he added.

"What we've learned today is that with Portico, the outcomes are actually quite good," Makkar told theheart.org | Medscape Cardiology. "They were very similar in terms of mortality, in terms of stroke, in terms of paravalvular leak to some of the more established technologies. Of course these are not randomized comparisons, these are real-life registry data, but these data are very encouraging."

Results from the 758-patient, open-label Portico US IDE study are expected early next year, said Makkar, who is a coprincipal investigator on that trial.

"There are some very positive attributes of this device and I think one of the most positive attributes is that it's a very flexible device and it's an easy-to-use device," he said. "So if the outcomes are excellent and are replicated in the US IDE study, I would imagine this will become one of the contenders on the cath lab shelves."

Søndergaard told theheart.org | Medscape Cardiology, "We do more than 300 TAVR cases in Copenhagen a year. This is our workhorse; we use it in more than 150 of the cases."

The trial was sponsored by Abbott, formerly St  Jude. Søndergaard reports consultant fees and institutional grants from Abbott. Makkar reports grant support/research contract with Abbott Vascular, Edwards Lifesciences, Medtronic, and Boston Scientific. Hermiller reports consultant fee/honoraria/speaker's bureau with Abbott Vascular and Boston Scientific.

Transcatheter Cardiovascular Therapeutics (TCT) 2018. Presented September 25, 2018.

J Am Coll Cardiol. Published online September 25, 2018. Abstract

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