Ventricular arrhythmias following transcatheter pulmonary valve replacement with the harmony TPV25 device

Abstract

Background Transcatheter pulmonary valve replacement (TPVR) with the Harmony valve (Medtronic, Inc.) was recently approved to treat postoperative native outflow tract pulmonary regurgitation. While the 22 mm Harmony valve Early Feasibility Study demonstrated ventricular tachycardia (VT) in only 5% of patients, little is known about ventricular arrhythmias after TPVR with the larger 25 mm valve (TPV25). Methods A single center review was performed of patients with TPV25 implant from 2020 to 2021. Demographic, cardiac, procedural, and postimplant cardiac telemetry data were collected and compared between patients who did and did not have peri‐implant ventricular arrhythmia. Results Thirty patients underwent TPV25 at a median age of 30 years. On postimplant telemetry, VT events were documented in 12 patients (40%); 11 nonsustained VT (NSVT) (median 3 episodes per patient and 6 beats per episode, maximum 157 episodes) and 1 sustained VT (3%), with Torsades de Pointes secondary to a short coupled premature ventricular contraction (PVC). VT events were associated with annular valve positioning (p < 0.001) and increased postimplant PVC burden (p < 0.0001), but there was no association between VT and other demongraphic, historical, or procedural factors. The frequency of NSVT events fell from 3/h from 0 to 12 h postimplant to 0.5/hr from 12 to 24 h (p < 0.001). Conclusion VT occurred commonly (40%) in the first 24 h after TPV25 implant, with self‐limited NSVT in 11 of 12 patients and 1 patient with cardiac arrest secondary to Torsades de Pointes. VT only occurred with annular valve positioning. Larger, longer‐term studies are needed to determine risk factors for and natural history of post‐TPVR VT.

Ventricular arrhythmias following balloon‐expandable transcatheter pulmonary valve replacement in the native right ventricular outflow tract

“…6 This protective effect may not apply in cases of novel TPVR devices that address larger RVOT diameters, as these are likely to be associated with myocardial interactions below the transannular patch from vertical and, perhaps more importantly, circumferential contact. 10 While ventricular arrhythmia occurrence is common following TPVR in the nRVOT, our data suggest that this is a benign and transient phenomenon. We anticipate that the results of this study will be helpful in guiding management of ventricular arrhythmias associated with ongoing balloon-expandable and new TPVR applications.…”

“…This suggests circumferential contact with RVOT myocardium may be more important than length of stent extension into the RVOT 6 . This protective effect may not apply in cases of novel TPVR devices that address larger RVOT diameters, as these are likely to be associated with myocardial interactions below the transannular patch from vertical and, perhaps more importantly, circumferential contact 10 …”

“…[5][6][7][8] Within nRVOTs, outcome data from TPVR have been derived from adult, or combined adult and pediatric, cohorts in which postintervention ventricular arrhythmia incidences ranged from 0.4% to 40%. [5][6][7][8][9][10] Ventricular arrhythmia incidence and sequelae in children and adolescents undergoing TPVR within the nRVOT are unknown. The time course for the resolution of these arrhythmias remains unclear.…”

“…One known complication associated with non‐nRVOT TPVR is ventricular arrhythmia, with reported incidences ranging from 3.4% to 9% 5–8 . Within nRVOTs, outcome data from TPVR have been derived from adult, or combined adult and pediatric, cohorts in which postintervention ventricular arrhythmia incidences ranged from 0.4% to 40% 5–10 . Ventricular arrhythmia incidence and sequelae in children and adolescents undergoing TPVR within the nRVOT are unknown.…”

Midterm Experience with the Self-Expandable Venus P-Valve™ for Percutaneous Pulmonary Valve Replacement in Large Right Ventricular Outflow Tracts

“…Nonetheless, one of our patients experienced a serious arrhythmic event with a sustained VT subsequently deteriorating to ventricular fbrillation; he had shown no relevant arrhythmias prior to discharge. Ventricular arrhythmias including VT have also been documented after PPVI with other self-expanding devices such as the Harmony ™ and the Alterra ™ but also with balloon-expandable valves [16,29,30]. While regular monitoring for arrhythmias is the standard of care in these patients and particularly essential before and after PPVI, there are currently no guildeline recommendations concerning preemptive electrophysiological studies to detect and ablate latent arrhythmogenic substrates, as recently advocated [28].…”