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Medical Specialties > Structural Heart > EuroPCR 2021 Clinical Presentation

Early neo2 Registry Videodensitometry Angiographic Core-Lab Analysis1,2

 

The Early neo2 Registry is an investigator-initiated and conducted, single arm, multicenter registry that retrospectively assessed the ACURATE neo2™ Valve outcomes in 554 patients across 12 centers.1

At EuroPCR 2021 data was presented on a separate videodensitometry angiographic core-lab adjudicated analysis comparing patients from the Early neo2 Registry implanted with the ACURATE neo2 Valve against patients implanted with the ACURATE neo™ Valve. In this study, the ACURATE neo2 Valve demonstrated a statistically significant lower rate of angiographically assessed moderate/severe aortic regurgitation (1.7% vs 13.9%, P<0.001).2

In the USA, the ACURATE neo2 valve is an Investigational Device and restricted under federal law to investigational use only, not available for sale. In the EU, the ACURATE neo2 Valve is CE marked.

 

Significant Aortic Regurgitation Reduction

 

A separate videodensitometry angiographic core-lab adjudicated analysis compared patients implanted with the ACURATE neo2 and ACURATE neo valves and demonstrated significant aortic regurgitation reduction.1

Percent of evaluable echocardiograms from a separate videodensitometry angiographic core-lab analysis of the Early neo2 Registry outcomes.1,*

ACURATE neo2 Aortic Valve System
* n = 120 Early neo2 Registry patients implanted with the ACURATE neo2 Valve (Karolinska University Hospital and Kerkhoff Klinik); n = 108 patients implanted with ACURATE neo (Karolinska University Hospital).
2. Buono A. Short-term outcomes of a novel self-expanding device: ITAL-neo Registry. Euro PCR 20211. Rück A. Results from the Early neo2 Registry on ACURATE neo2 TAVI Valve. EuroPCR congress. 2021. conference. 2021.
 

 

Key ITAL-neo Registry3 Outcomes

 

The ITAL-neo was an investigator-initiated and conducted, single arm, and multicenter Registry. From September 30th 2020 to March 1st 2021, ACURATE neo2 Valve outcomes were evaluated in 95 patients across 9 centers in Italy.

Key Registry outcomes:

  • Device success rate; 97.9%
  • In-hospital PVL rate; 3.1% moderate/severe*
  • In-hospital new permanent pacemaker implantation rate; 11.2%
  • Pre-discharge mean gradient; 8.2mmHg*
  • In-hospital Stroke rate; 1.1%

 

Acurate neo2 ital neo registry chart
* Pre-discharge Echo
3. Buono A. Short-term outcomes of a novel self-expanding device: ITAL-neo Registry. Euro PCR 2021 conference. 2021.
 
 

 

Analysis of Aortic Root Anatomy on Peri-Procedural TAVR Stroke4

 

Dr Henrik Bjursten, Lund University, presented a retrospective, propensity score-matched analysis of 3,341 patients from SWENTRY (SWEdish traNscatheter cardiac inTernevtion regsitRY) between 2014 and 2018 (before SENTINEL™ Cerebral Protection System was used) to determine if aortic root anatomy characteristics and calcium load and distribution contribute to the risk for peri-procedural stroke in TAVR.

Pre-procedural CT images from 51 TAVR patients who developed peri-procedural stroke were compared against a propensity score-matched cohort of 51 TAVR patients who did not develop stroke. Pre-procedural images were reviewed by a cardiothoracic radiologist and stroke was site-reported as part of the national registry.

The analysis concluded that aortic root characteristics based on CT analysis were not predictive of peri-procedural stroke in TAVR. Further, no differences were found between patients with and without peri-procedural stroke when comparing calcium load and distribution within the aortic root.

  • Commissural bridge calcium: No difference in stroke risk, P = 0.527
  • Annulus calcium: No difference in stroke risk, P > 0.05 for all calcium characteristics
  • LVOT calcium: No difference in stroke risk, P > 0.05 for all calcium characteristics
4. Bjursten H. Radiological predictors for a peri-procedural stroke during TAVI. 
 
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