Feature | Structural Heart | May 26, 2021

Acurate neo2 TAVR Valve Demonstrate Reduced Paravalvular Leak and Low Permanent Pacemaker Rates 

Late-breaking registry data at EuroPCR shows better outcomes than first-generation Acurate neo device.

The Acurate neo2 TAVR valve design enhancements include a 60% larger outer sealing skirt to conform to challenging anatomies. This has minimized paravalvular leaks and imporved clinical outcomes compared to the previous-generation Acurate neo Aortic Valve System. #EuroPCR #EuroPCR21 #EuroPCR2021

The Acurate neo2 TAVR valve design enhancements include a 60% larger outer sealing skirt to conform to challenging anatomies. This has minimized paravalvular leaks and imporved clinical outcomes compared to the previous-generation Acurate neo Aortic Valve System.

May 26, 2021 — Data presented at hotline and late-breaking trial sessions at the EuroPCR 2021 congress for the updated Boston Scientific Acurate neo2 transcatheter aortic valve replacement (TAVR) system demonstrated positive procedural performance. This including low rates of paravalvular leakage (PVL) and permanent pacemaker implementation (PPI), areas where the first generation Acurate neo heart valve did not perform as well. 

The new data was reflected in the the investigator-initiated Early neo2 Registry and ITAL-neo Registry studies.[1,2]

"These real-world findings reinforce the effectiveness of the Acurate neo2 valve design enhancements –including the 60% larger outer sealing skirt to conform to challenging anatomies – that have minimized PVL and shown excellent clinical outcomes in a broad spectrum of patients when compared to data collected with the previous-generation Acurate neo Aortic Valve System," said Dr. Ian Meredith, global chief medical officer, Boston Scientific.

EARLY neo2 Registry Results Show Promise for The Acurate neo2 TAVR Valve

The Early neo2 Registry, presented by Andreas Rück, M.D., Ph.D., interventional cardiologist, Karolinska University Hospital Stockholm, is the first large real-world report of clinical experience with the Acurate neo2 device. 

Key findings from this retrospective analysis of 554 patients from 12 European centers included:
   • 1.3% post-operative moderate/severe PVL rate which was lower than the rate observed in prior studies with the Acurate neo device. The mild and none/trace PVL rates were 33.3% and 65.4%, respectively.[3]
   • 6% in-hospital PPI rate
   • 2.1% in-hospital stroke rate
   • 1.3% mortality rate at 30 days and excellent hemodynamics (mean gradient of 9mmHg)

Early neo2 Registry data were further evaluated in a separate quantitative assessment of angiographic aortic regurgitation in 228 patients treated with either the Acurate neo valve system or Acurate neo2 valve system, also presented by Rück at EuroPCR as a poster.[4] 

These results demonstrated that the Acurate neo2 device was associated with significantly less aortic regurgitation when compared with the prior-generation Acurate neo device. The mean aortic regurgitation fraction rate (the percentage of blood that flows back through the aortic valve) was 4.4% with the Acurate neo2 device vs. 9.9% with the Acurate neo device (p<0.001). 

This equates to a 56% relative reduction in the mean aortic regurgitation fraction.

Results of the ITAL-neo Registry Using the  Acurate neo2 TAVI  System

The retrospective ITAL-neo Registry was presented by Dr. Andrea Buono, MBBS, an interventional cardiologist at Fondazione Poliambulanza Istituto Ospedaliero in Brescia, Italy. It included 95 TAVI patients from nine Italian centers and evaluated in-hospital device success and in-hospital patient outcomes with the Acurate neo2 device. 

Key findings included:
   • 3.1% pre-discharge moderate/severe PVL rate. This rate, in addition to the mild and none/trace PVL rates (56.9% and 40%), was lower than previously reported rates in studies of the Acurate neo device.[5,6]
   • 97.9% device success rate
   • 1.1% in-hospital stroke rate
   • 11.2% in-hospital new PPI rate and excellent hemodynamics (pre-discharge mean gradient of 8.2 mmHg).[1] 

About the Acurate neo2 Transcatheter Valve System

The Acurate neo2 Valve System received CE Mark in 2020 and is indicated for patients with aortic stenosis – with no specified age or risk level – who are considered appropriate candidates for transcatheter aortic valve implantation by their heart team, including a cardiac surgeon.

Boston Scientific is currently enrolling patients in the ACURATE IDE, the pivotal U.S. trial evaluating the safety of the Acurate neo2 Aortic Valve System. In April 2021, the company received FDA approval to modify the trial design to study patients with severe, symptomatic aortic stenosis who are at low risk of open-heart surgery, in addition to those at intermediate, high and extreme risk.

In the U.S., the Acurate neo2 Aortic Valve System is an investigational device and not available for sale.

 

First-generation Acurate neo Did Not Perform Well When Compared to Sapien and CoreValve

The first-generation Acurate Neo valve had poor results in two late-breaking trial presentations at TCT 2019 when compared to the current generation Sapien and CoreValve systems. Boston Scientific had already redesigned the valve to solve the performance issued and introduced the Acurate neo2 by the time these trials were presented.

The SCOPE I Trial of the Acurate Neo versus the Sapien 3 in patients with severe aortic stenosis did not meet non-inferiority.

"The device was designed as a hybrid valve, blending the benefits of a self-expanding device with having specific annular contact with the aim of lowering pacemakers and stroke rates," explained Chandan Devireddy, M.D., at the 2019 meeting. He is cath lab director at Emory University Hospital Midtown, and a spokesman for the Society of Cardiovascular Angiography and Interventions (SCAI). "The data was not a happy story. It was designed as a non-inferiority trial, and it did not meet that. Instead it showed it was inferior against the Edwards Sapien valve."

He said the poorer outcomes were mainly driven by a higher rate of kidney injury, possibly from use of more contrast, and a high rate of paravalvular leak (PVL). 

"Now we are in the third, if not the fourth, generation world of transcatheter devices. So that high a level of moderate PVL as seen in the Acurate Neo trial, it is a bitter pill to swallow. In 2019, the current generation of the Accurate Neo is not ready for prime time," Devireddy said.

He did note stroke rates were lower with the new device and that Boston Scientific has already developed a second generation device. The new version of the Accurate Neo valve has additional material at the base designed to reduce PVL. The new data presented at EuroPCR 2021 confirm the deign change led to much better outcomes.

For more information: www.bostonscientific.com

 

Related Acurate neo TAVR Valve Content:

VIDEO: Acurate neo2 TAVR Valve Performs Well in Latest Trials — Interview with Doctor Andreas Ruck

TAVR Is Now Dominant Form of Aortic Valve Replacement in the United States

Boston Scientific Launches Acurate neo2 Transcatheter Aortic Valve System in Europe

New Acurate neo Self-expanding TAVR Device Does Not Meet Non-Inferiority Compared to Sapien 3

Acurate neo TAVR Valve Fails to Meet Noninferiority With Medtronic CoreValve Evolut

VIDEO: Interventional Structural Heart Advances Are Rapidly Expanding — Interview with Juan F. Granada, M.D.

Boston Scientific to Acquire TAVR Maker Symetis

Boston Scientific Pulls Lotus Edge TAVR Valve Off The Market

VIDEO: SCAI Prospective on Key Takeaways at TCT 2019 — Interview with Chandan Devireddy, M.D.

 

References:

1. Rück A. Results from the Early neo2 registry Acurate neo2 TAVI valve. Euro PCR 2021 conference. 2021.

2. Buono A. Short-term outcomes of a novel self-expanding device: ITAL-neo Registry. Euro PCR 2021 conference. 2021.

3. Transcatheter Aortic Valve Replacement With the ACURATE neo2 Valve System: 1 Year Clinical and Hemodynamic Outcomes. Presented by H. Möllmann at TVT Chicago 2019.

4. Ruck A. Quantitative Angiographic Assessment of Aortic Regurgitation Following the ACURATE neo2 Versus ACURATE neo Valve implantation. Euro PCR 2021 conference. 2021.

5. Lanz J., et al. Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial. Lancet. 2019;394(10209):1619-28.

6. Tamburino C., et al. Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis. SCOPE 2 Randomized Clinical Trial. Circulation 2020;142:2431–2442.
 

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