scholarly journals Systematic Approach to High Implantation of SAPIEN-3 Valve Achieves a Lower Rate of Conduction Abnormalities Including Pacemaker Implantation

Author(s):  
Yasser Sammour ◽  
Kinjal Banerjee ◽  
Arnav Kumar ◽  
Hassan Lak ◽  
Sanchit Chawla ◽  
...  

Background: The conventional method of implanting balloon-expandable SAPIEN-3 (S3) valve results in a final 70:30 or 80:20 ratio of the valve in the aorta:left ventricular outflow tract with published rates of permanent pacemaker around 10%. We sought to evaluate whether higher implantation of S3 reduces conduction abnormalities including the need for permanent pacemaker. Methods: We included consecutive patients who underwent transfemoral transcatheter aortic valve replacement using S3 between April 2015 and December 2018 and compared outcomes with typical valve deployment strategy to our more contemporary high deployment technique (HDT). We excluded patients with nontransfemoral access or valve-in-valve. Results: Among 1028 patients, HDT was performed in 406 patients (39.5%). Mean implantation depth under the noncoronary cusp was significantly smaller with HDT compared with conventional technique (1.5±1.6 versus 3.2±1.9 mm; P <0.001). Successful implantation was achieved in 100% of the patients in both groups with no cases of conversion to open heart surgery, second valve implantation within the first transcatheter aortic valve replacement, or coronary occlusion during transcatheter aortic valve replacement. One patient (0.2%) had valve embolization with HDT ( P =0.216). Thirty-day permanent pacemaker rates were lower with HDT (5.5% versus 13.1%; P <0.001), as were rates of complete heart block (3.5% versus 11.2%; P <0.001) and new-onset left bundle branch block (5.3% versus 12.2%; P <0.001). There were no differences in mild (16.5% versus 15.9%; P =0.804), or moderate-to-severe aortic regurgitation (1% versus 2.7%; P =0.081) at 1 year. HDT was associated with slightly higher 1-year mean gradients (13.1±6.2 versus 11.8±4.9 mm Hg; P =0.042) and peak gradients (25±11.9 versus 22.5±9 mm Hg; P =0.026). However, Doppler velocity index was similar (0.47±0.15 versus 0.48±0.13; P =0.772). Conclusions: Our novel technique for balloon-expandable S3 valve positioning consistently achieves higher implantation resulting in substantial reduction in conduction abnormalities and permanent pacemaker requirement after transcatheter aortic valve replacement without compromising procedural safety or valve hemodynamics. Operators should consider this as an important technique to improve patient outcomes.

Circulation ◽  
2020 ◽  
Vol 142 (25) ◽  
pp. 2431-2442 ◽  
Author(s):  
Corrado Tamburino ◽  
Sabine Bleiziffer ◽  
Holger Thiele ◽  
Smita Scholtz ◽  
David Hildick-Smith ◽  
...  

Background: Few randomized trials have compared bioprostheses for transcatheter aortic valve replacement, and no trials have compared bioprostheses with supra-annular design. The SCOPE 2 trial (Safety and Efficacy Comparison of Two TAVI Systems in a Prospective Randomized Evaluation 2) was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut bioprostheses for transcatheter aortic valve replacement. Methods: SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years old with an indication for transfemoral transcatheter aortic valve replacement as agreed by the heart team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary end point, powered for noninferiority of the ACURATE neo bioprosthesis, was all-cause death or stroke at 1 year. The key secondary end point, powered for superiority of the ACURATE neo bioprosthesis, was new permanent pacemaker implantation at 30 days. Results: Among 796 randomized patients (mean age, 83.2±4.3 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 4.6±2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary end point occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference, 1.8%, upper 1-sided 95% confidence limit, 6.1%; P =0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference, –7.5% [95% CI, –12.4 to –2.60]; P =0.0027). No significant differences were observed in the components of the primary end point. Cardiac death at 30 days (2.8% versus 0.8%; P =0.03) and 1 year (8.4% versus 3.9%; P =0.01), and moderate or severe aortic regurgitation at 30 days (10% versus 3%; P =0.002) were significantly increased in the ACURATE neo group. Conclusions: Transfemoral transcatheter aortic valve replacement with the self-expanding ACURATE neo did not meet noninferiority compared with the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and it was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03192813.


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