Safety, Efficacy and Long-Term Outcomes of Patients Treated with the Occlutech Paravalvular Leak Device for Significant Paravalvular Regurgitation

Abstract

Between December 2014 and March 2021, 144 patients with aortic (Ao) or mitral (Mi) paravalvular leaks (PVLs) were enrolled at 21 sites in 10 countries. Safety data were available for 137 patients, who were included in the safety analysis fraction (SAF), 93 patients with Mi PVLs and 44 patients with Ao PVLs. The full analysis set (FAS) comprised 112 patients with available stratum (aortic/mitral leak) as well as baseline (BL), 180-day or later assessments (2 years). Procedural success (implantation of the device with a proper closure of the PVL, defined as reduction in paravalvular regurgitation of ≥one grade as assessed by echocardiography post implantation) was achieved in 91.3% of FAS patients with Mi PVLs and in 90.0% of those with Ao PVLs. The proportion of patients suffering from significant or severe heart failure (HF), classified as New York Heart Association (NYHA) class III/IV, decreased from 80% at baseline to 14.1% at 2-year follow-up (FAS). The proportion of FAS patients needing hemolysis-related blood transfusion decreased from 35.5% to 3.8% and from 8.1% to 0% in Mi patients and Ao patients, respectively. In total, 35 serious adverse events (SAEs) were reported in 27 patients (19.7%) of the SAF population. The SAEs considered possibly or probably related to the device included device embolization (three patients), residual leak (two patients) and vascular complication (one patient). During follow-up, 12/137 (8.8%) patients died, but none of the deaths was considered to be device-related. Patients implanted with the Occlutech Paravalvular Leak Device (PLD) showed long-lasting improvements in clinical parameters, including NYHA class and a reduced dependency on hemolysis-related blood transfusions.

Percutaneous Closure of Mitral Paravalvular Leak: Long-Term Results in a Single-Center Experience

“…To date, there are only three studies reporting long-term outcomes ≥2 years after percutaneous mitral PVL closure procedures [ 24 , 27 , 28 ]. In 2017, Alkhouli et al reported a long-term survival rate of 50.3% following percutaneous mitral PVL closure in 195 patients, with a mean follow-up period of 3.7 ± 2.7 years [ 24 ].…”

“…In 2017, Alkhouli et al reported a long-term survival rate of 50.3% following percutaneous mitral PVL closure in 195 patients, with a mean follow-up period of 3.7 ± 2.7 years [ 24 ]. More recently, Onorato et al described a 91.3% technical success rate employing the dedicated Occlutech PVL device (Occlutech, GmbH, Jena, Germany) in a single-center registry including 93 mitral PVL and 44 aortic PVL procedures [ 27 ]. Overall mortality rate at 2 years was 8.3% in this study.…”

“…Although long-term mortality and MACE rates in our study were considerable, particularly beyond 1-year follow-up, they were similar to those reported by Alkhouli et al [ 24 ] and Perl et al [ 28 ]. Regarding the lower mortality rates observed in the Occlutech registry [ 27 ], there are several factors that limit an accurate comparison with the results of our study: first, patients included in the Occlutech trial were younger (mean age 66.7 vs. 71.1 years) and presented a lower prevalence of underlying comorbidities such as chronic kidney disease (15.3% vs. 30.2%) and COPD (5.6% vs. 9.4%), amongst others. Furthermore, the Occlutech trial reported outcomes for the whole sample comprising mitral and aortic PVL closure procedures, while a mitral versus aortic PVL location has been previously associated with a higher rate of events during follow-up [ 17 , 18 ].…”

Paravalvular Leakages after Surgical Aortic-Valve Replacement and after Transcatheter Aortic-Valve Implantation: Strategies to Increase the Success Rate of Percutaneous Closure

“…as a co-author of Spanish Real World PVLs Closure Registry [ 3 ], and E.M.O. as the principal investigator and coordinator of the International Multicenter PLD Registries [ 4 , 5 ] with a cohort of more than 200 patients, and from their knowledge of the literature and other experts’ experience through regular case discussions.…”

“…The PLD has a special braiding that avoids a distal hub, giving flexibility and adaptability with a high success rate in achieving complete closure. In cases with large crescent-shaped defects requiring multiple vascular plugs, the implantation of a single large rectangular device to the edges increases the success rate and lowers residual regurgitation without interfering with the valve ( Figure 1 and Figure 2 , Supplementary Figures S1 and S2 ) [ 4 , 5 , 11 , 12 , 13 ].…”