麻豆传媒

Transcatheter aortic valve replacement (TAVR) with the second-generation Lotus valve was associated with low rates of aortic regurgitation in short- and mid-term results.

At 1 year, . The majority had mild symptoms at most, with 97.1% in New York Heart Association functional class I or II.

The incidence of all-cause death was 10.9%, disabling stroke 3.4%, and disabling bleeding 5.9%, according to the REPRISE II study published in JACC: Cardiovascular Interventions.

In addition, there were no repeat procedures for valve dysfunction, although 31.9% of patients had received implantation of a new permanent pacemaker by the 1-year mark.

"We report that the Lotus Valve has favorable valve performance and sustained hemodynamic and clinical benefits," , of Australia's Monash Medical Centre, and colleagues wrote.

The low rates of aortic regurgitation mark "significant progress" over first-generation devices, "where moderate-to-severe aortic regurgitation occurred in 9% to 30% of patients with a proven negative impact on outcomes," according to Alec Vahanian, MD, and Dominique Himbert, MD, both of Bichat Hospital in Paris.

Nonetheless, they noted in an accompanying editorial that the incidence of pacemaker implantation may be Lotus' "Achilles heel," as it is higher than what was previously seen with other new-generation devices.

However, this risk should decline when the Lotus becomes compatible with more valve sizes, they wrote.

There were 120 patients studied in REPRISE II. All had severe calcific aortic stenosis and were deemed poor matches for surgery.

Mean aortic gradients fell from 46.4 mm Hg at baseline to 12.6 mm Hg 1 year after discharge (P<0.001). Over the same period, the effective orifice area increased from 0.7 cm² to 1.7 cm² (P<0.001).

The upcoming FDA approval study, named REPRISE III, is currently enrolling patients for a randomized comparison with the CoreValve, Meredith and colleagues noted. That trial "is expected to add considerably to the body of evidence for TAVR."

In a separate British investigation of Lotus implantation, short-term outcomes were similar.

The incidence of in-hospital mortality was 1.8%, cardiac tamponade 1.8%, conversion to sternotomy 1.3%, stroke 3.9%, vascular access-related injury 7.0%, and acute kidney injury 7.9%.

Moderate-to-severe aortic regurgitation occurred in 0.8% of cases, but 31.8% of patients required a new permanent pacemaker, , of Sussex Cardiac Centre in Brighton, England, and colleagues found.

Nonetheless describing the results as "excellent" in JACC: Cardiovascular Interventions, the authors wrote that "the Lotus valve improves on first-generation valves, particularly with regard to residual aortic regurgitation."

According to , and , both of Bern University Hospital in Switzerland, the findings "provide surgery-like outcomes and are an important prerequisite to allow extension of TAVR to lower risk patients."

Lotus has several features that make it "a valuable asset" for treating certain patients with valvular heart disease, the editorialists concluded.

For one, they wrote in an accompanying editorial, the device "can be implanted without systemic pre-dilation and obviates the need for rapid ventricular pacing, which may be helpful in the treatment of patients with severely compromised left ventricular function."

The retrospective study included 228 U.K. patients who were implanted with the Lotus valve between 2013 and 2015.

More than half of patients (55.2%) developed a left bundle branch block after the procedure.

"The vast majority of patients (76.1%) did not have any residual regurgitation," Hildick-Smith's group added, suggesting that this may be due to "the adaptive seal surrounding the ventricular portion of the prosthesis designed to reduce gaps between the device and native tissue, and the ability to reposition the device in cases of suboptimal deployment."

However, "the current focus of this analysis was on in-hospital outcomes, and thus, our results cannot be extrapolated to longer-term follow-up," they acknowledged. They were also unable to "rule out underreporting of adverse events" due to the retrospective nature of their investigation.

Despite these limitations, Pilgrim and Windecker concluded that "refinement of the system with smaller delivery catheter profiles and extension of the device range to accommodate larger aortic valve anatomies will further increase the use of this newer generation transcatheter prosthesis."