Thirty-day Outcomes with Sapien 3 Lowest Seen with Balloon-Expandable TAVR

SAN DIEGO, CA—Thirty-day event rates—especially paravalvular regurgitation—after TAVR with the Sapien 3 prosthesis are lower than what has been seen in any prior balloon-expandable TAVR trial in patients at all risk levels, according to results presented March 15, 2015, at the American College of Cardiology/i2 Scientific Session.

“The rapid evolution of balloon-expandable TAVR, both procedural developments and technical enhancements, represented in the Sapien 3 clinical and echo results, indicates at least parity with the best surgical outcomes in comparable patients,” said presenter Susheel K. Kodali, MD, of Columbia University Medical Center (New York, NY). “Sapien 3 TAVR should now be considered as an alternative to surgery, even in lower-risk patients with aortic stenosis.”

The Sapien 3 device (Edwards Lifesciences) is different than the prior devices released by the same manufacturer in that it has a skirt designed to prevent paravalvular leak, improved coaxial alignment, and more accurate positioning.

Dr. Kodali and colleagues looked at data from 2 nonrandomized registries embedded in the PARTNER II trial on 1,076 intermediate-risk patients (average age 81.9 years; 38% female; average STS score 5.3%) and 583 inoperable or high-risk patients (average age 82.6 years; 42% female; average STS score 8.6%) who underwent TAVR with the Sapien 3 valve via the transfemoral, transapical, or transaortic approach.

Patients in both cohorts reported a high incidence of comorbidities, including previous CABG, peripheral vascular disease, diabetes, and A-fib. All patients were symptomatic, although slightly more patients in the high-risk cohort were deemed to be in NYHA class III/IV and to be frail. About 17% of the intermediate-risk cohort received conscious sedation rather than general anesthesia.

Very Low Event Rates with Sapien 3

Mortality and stroke at 30 days were low in both study groups (table 1).

 

Event rates were slightly increased in the context of transapical/transaortic vs transfemoral procedures among high-risk patients. 

In the context of prior PARTNER trials, “there's a dramatic downshifting of mortality from 6.3% at 30 days to now around 1%,” Dr. Kodali reported. “Even [with the] transthoracic approach, there's been an improvement in mortality from 8.7% in the original trial to 1.6% in the intermediate-risk cohort now.”

Other event rates, including bleeding, were low in both groups, and there were no annular ruptures. Permanent pacemaker rates were 13% and 10.1% in the high- and intermediate-risk cohorts, and NYHA functional class improved for all—87% and 94% of high- and intermediate-risk patients, respectively, were NYHA class I or II at 30 days.

On echocardiography, valve area increased from 0.69 to 1.67 cm² at follow-up. The increase was dependent on the valve size implanted, with the 29-mm valve associated with the lowest mean gradient.

Overall moderate and severe paravalvular regurgitation rates were very low at 30 days:

 

• Severe: 0.1%
• Moderate: 3.7%
• Mild: 41.3%
• None/Trace: 55.0%

 

In the context of prior studies, these were the lowest paravalvular leak rates recorded with any balloon-expandable valve, Dr. Kodali said.

Outcomes Tied to Increased Skill, Changes to Device

Session moderator Athena Poppas, MD, of Brown University (Providence, RI), asked about how the changes to the structure of the device interplayed with the new mandates for 3D imaging analysis to potentially reduce paravalvular leak.

Dr. Kodali acknowledged the growing procedural skill among interventionalists, but said the improved events are likely a combination of the skirt, which “gives you more leeway,” and better sizing algorithms.

Panelist Ian T. Meredith, MBBS, PhD, of Monash Medical Centre Clayton (Melbourne, Australia), called the study “simply stunning and very impressive” but wanted Dr. Kodali to tease out what contributed to the low mortality and stroke rates in the study.

While Doppler studies have shown that embolic events typically occur during valve positioning, Dr. Kodali highlighted the low profile of Sapien 3 leading to “a lower footprint in terms of crossing,” as well as the frame-sealing balloon “so it’s less traumatic in crossing the valve.” Additionally, the valve can be positioned finely, allowing an operator to “dial in and out, so you're not really manipulating the valve that much during positioning,” he said.

How Much More Information is Necessary?

“The bar keeps getting higher and higher,” said panelist Jeffrey J. Popma, MD, of Beth Israel Deaconess Hospital (Boston, MA). “This data is so clean. What more information do we really need once the device performs this well at 30 days?”

Additionally, he questioned whether new-generation valves need to be evaluated past 30 days “once the platform has been established.”

In terms of late events, Dr. Kodali said signals will not be seen at 1 or 2 years, but rather 8 or 10 years. “The conversations are changing,” he observed. “It used to be: ‘Who’s going to do poorly with surgery? Let's do TAVR.’ Maybe we have to start having the discussion, ‘Who does well with TAVR? Maybe TAVR should be the preferred therapy.”

 

 

 

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Source:

 

Kodali S. Early clinical and echocardiographic outcomes with the Sapien 3 transcatheter aortic valve replacement system in inoperable, high-risk, and intermediate-risk aortic stenosis patients. Presented at: American College of Cardiology/i2 Scientific Session; March 15, 2015; San Diego, CA.

Disclosures:

 

• Dr. Kodali reports receiving grant/research support from Boston Scientific, Claret Medical, Edwards Lifesciences, and Medtronic; serving on the steering committee for Claret Medical, Edwards Lifestyle, and Meril; holding equity in Thubrikar Aortic Valve; and receiving honoraria from Claret Medical and St. Jude Medical.
• Dr. Popma reports receiving consulting fees/honoraria from Abbott, Abbott Vascular, Abiomed, Boston Scientific, and Cordis and research grants from Abbott, Abbott Vascular, Abiomed, Boston Scientific, Cordis, eV3, and Medtronic.
• Dr. Poppas reports no relevant conflicts of interest.
• Dr. Meredith reports receiving consulting fees/honoraria from Boston Scientific, Guided Delivery Systems, and Medtronic Vascular.

 

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• Low Mortality, Stroke With Transfemoral Implant of Sapien 3
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• Excellent Early Experience Reported With Edwards SAPIEN 3 Transcatheter Valve