New Iteration of Sapien Device Associated with Low Rates of Early Mortality, Stroke

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A new lower-profile valve and delivery system for transcatheter aortic valve replacement (TAVR) appears promising, with low mortality and stroke rates, and few access-site complications, according to a study presented May 20, 2014 in a late-breaking trial session at EuroPCR in Paris, France.

Investigators led by John Webb, MD, of University of British Columbia (Vancouver, Canada), looked at 30-day outcomes in 150 patients from 16 sites in Europe and Canada implanted with the Sapien 3 prosthesis (Edwards Lifesciences; Irvine, CA) between January 2013 and November 2013.

Patients were classified as:

  • High risk (n = 50; STS score ≥ 8 or Logistic EuroSCORE ≥ 15)
  • High or intermediate risk (n = 100; STS score ≥ 4 to < 8 or Logistic EuroSCORE ≥ 10 to < 15)

Early Results Encouraging

The majority of procedures were performed transfemorally (n = 96). At 30 days, the rate of all-cause mortality (primary endpoint) was low in the overall population, as were rates of stroke and access-site complications (table 1).

Table 1. Outcomes at 30 Days

 

All Patients
(n = 150)

Transfemoral TAVR
(n = 96)

Transapical/Transaortic TAVR
(n = 54)

All-cause Mortality

5.3%

2.1%

11.1%

Cardiac Mortality

4.7%

2.1%

9.3%

Stroke

2.7%

1.0%

5.6%

Major Vascular Complication

6.0%

5.2%

7.4%

Major Bleeding

20.0%

19.8%

20.4%

Life-threatening Bleeding

3.3%

2.1%

5.6%


The rate of technical success was 94.0% and 99.3% of valves were implanted at the intended location.

Echocardiographic data showed that the majority of patients (72.4%) had no/trace paravalvular aortic regurgitation, with no cases of severe aortic regurgitation in either the transfemoral or transapical/transaortic group. However, the rate of new permanent pacemaker implantation was 13.3%.

Approximately 87% of patients were in NYHA stage III/IV heart failure at baseline. At 30 days, this number was reduced to 6.6% (P < .0001). Quality of life improvements also were seen.

Potential for Use in Intermediate-Risk Patients

“These data demonstrated that the improved valve and delivery system design allowed precise positioning of the SAPIEN 3 valve, and early outcomes from the trial clearly demonstrated outstanding safety,” Dr. Webb said in a press release. “The results of this study indicate the Sapien 3 valve may enable treatment of intermediate-risk patients with aortic stenosis.”

Due to its lower profile, the Sapien 3 can be delivered through a 14-Fr expandable sheath. It also has an outer skirt—a cuff of fabric that provides a seal at the bottom of the frame— designed to reduce paravalvular aortic regurgitation, according to the press release.

The valve was approved in Europe in January 2014 for the treatment of high-risk and inoperable patients with severe aortic stenosis. It is not approved for the treatment of intermediate risk patients in Europe. In the United States, the Sapien 3 is being evaluated in the PARTNER II trial.

Experience May Play Role

In a telephone interview with TCTMD, Susheel K. Kodali, MD, of Columbia University Medical Center (New York, NY), said the low mortality and stroke rate as well as minimal paravalvular leakage are encouraging.

“The ‘skirt’ on the device is sort of like extra material that helps fill in gaps when you deploy the valve so that you get a better seal,” Dr. Kodali said, adding that the smaller size combined with a transfemoral approach also benefits patients in terms of being able to leave the hospital sooner.

Dr. Kodali said while the high rate of permanent pacemaker implantation is a concern, it may be a reflection of early experience.

“This is a taller frame and there is a learning curve in how to deploy this valve compared with the others,” he said. “I think initially they may have been placed a little bit lower than what was intended and that is what led to the higher pacemaker rates. So, this is something we have to keep an eye on going forward.”

Study Details

Mean age was 83.6 years and 54% of patients were female.

 


Source:
Webb J. 30-day outcomes from the Sapien 3 trial. Presented at: EuroPCR; May 20, 2014; Paris, France.

 

 

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Disclosures
  • Dr. Webb reports serving as a consultant for Edwards Lifesciences.
  • Dr. Kodali reports serving as a consultant to the PARTNER trial steering committee.

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