Boston Scientific announced that data presented at hotline and late-breaking trial sessions today at the EuroPCR 2021 congress demonstrated positive procedural performance, including low rates of paravalvular leakage (PVL) and permanent pacemaker implementation (PPI), of the Boston Scientific (NYSE: BSX) ACURATE neo2™ Aortic Valve System within the investigator-initiated Early neo2 Registry1 and ITAL-neo Registry2 studies.
“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
The Early neo2 Registry, presented by Dr. Andreas Rück, 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 Dr. 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.
The retrospective ITAL-neo Registry, which was presented by Dr. Andrea Buono, interventional cardiologist, Fondazione Poliambulanza Istituto Ospedaliero in Brescia, Italy, included 95 TAVI patients from nine Italian centers and evaluated in-hospital device success and in-hospital patient outcomes with the ACURATE neo2 device. 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
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.