Log in to MyACC
TAVR With LOTUS Edge System: Early European Experience
Quick Takes
- This European clinical experience among an all-comers patient population reports satisfactory clinical outcomes and hemodynamic results with the LOTUS Edge system.
- However, the requirement for new PPM implantation remains high with this system.
- The ongoing RESPOND EDGE post market study (NCT04009720) will provide additional real-world clinical and device performance outcomes data with the LOTUS Edge system.
Study Questions:
What is the short-term safety and efficacy of transcatheter aortic valve replacement (TAVR) with the LOTUS Edge system?
Methods:
The investigators conducted a multicenter, single-arm, retrospective registry to evaluate short-term clinical outcomes with the LOTUS Edge system. Included cases are the first experience with this device and new implantation technique in Europe. Clinical, echocardiographic, and computed tomographic data were analyzed. The primary objective of this study was to investigate the 30-day safety and efficacy of this novel transcatheter heart valve system. Endpoints were defined according to Valve Academic Research Consortium 2 (VARC-2) criteria and were site-reported. Specifically, 30-day all-cause mortality, which was further divided into cardiovascular and noncardiovascular death, and stroke, which was adjudicated as disabling or nondisabling, according to the VARC-2 criteria were assessed. A univariate analysis for predictors of 30-day stroke was performed using all baseline characteristics and procedural factors potentially relevant in the development of this endpoint. Multivariable analysis was subsequently performed using variables with p value < 0.20 in the univariate analysis.
Results:
Between April and November 2019, 286 consecutive patients undergoing TAVR with the LOTUS Edge system in 18 European centers were included. The mean age and Society of Thoracic Surgeons (STS) score were 81.2 ± 6.9 years and 5.2 ± 5.4%, respectively. Nearly half (47.9%) of all cases were considered to have complex anatomy. Thirty-day major adverse events included death (2.4%; n = 7) and stroke (3.5%; n = 10). After TAVR, the mean aortic valve area was 1.9 ± 0.9 cm2 and the mean transvalvular gradient was 11.9 ± 5.7 mm Hg. None or trace paravalvular leak (PVL) occurred in 84.4% and moderate PVL in 2.0%. There were no cases of severe PVL. New permanent pacemaker (PPM) implantation was required in 25.9% among all patients and 30.8% among PPM-naive patients.
Conclusions:
The authors concluded that early experience with the LOTUS Edge system demonstrated satisfactory short-term safety and efficacy, favorable hemodynamic data, and very low rates of PVL in an anatomically complex cohort.
Perspective:
This European clinical experience with the LOTUS Edge system among an all-comers patient population reports satisfactory clinical outcomes and hemodynamic results, and very low rates of clinically significant PVL in an anatomically complex patient cohort. However, the requirement for new PPM implantation remains high. It should be noted that the relatively small sample size of the study population and the retrospective design with only 30-day follow-up limits the development of firm conclusions. Additional studies are indicated to assess whether the depth guard technique and an increasing operator experience may reduce the need for PPM implantation. The ongoing RESPOND EDGE post market study (NCT04009720) will provide real-world clinical and device performance outcomes data with the LOTUS Edge system.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Computed Tomography, Echocardiography/Ultrasound, Nuclear Imaging
Keywords: Cardiac Surgical Procedures, Diagnostic Imaging, Echocardiography, Geriatrics, Heart Valve Diseases, Heart Failure, Hemodynamics, Lotus, Pacemaker, Artificial, Stroke, Tomography, X-Ray Computed, Transcatheter Aortic Valve Replacement, Vascular Diseases, Transcatheter Cardiovascular Therapeutics, TCT20
< Back to Listings
