Extended Rhythm Monitoring to Assess for Ventricular Arrhythmias After Transcatheter Pulmonary Valve Replacement with the Harmony Valve.

Extended Rhythm Monitoring to Assess for Ventricular Arrhythmias After Transcatheter Pulmonary Valve Replacement with the Harmony Valve.

Yang JK, Wattenbarger L, Taylor AC, Chubb H, Romfh AW, Peng LF, Ceresnak SR, Dubin AM, McElhinney DB.  Circ Cardiovasc Interv. 2025 Jan;18(1):e014381. doi: 10.1161/CIRCINTERVENTIONS.124.014381. Epub 2024 Dec 27. PMID: 39727055

Commentary by:

Konstantin Averin

Dr. Konstantin Averin (Cohen Children’s Heart Center), catheterization section editor of Pediatric Cardiology Journal Watch:

Take-home Points:

  1. Non-sustained ventricular tachycardia (NSVT) and ventricular ectopy are common immediately after Harmony TPVR, occurring in 50% of patients. However, these arrhythmias are typically infrequent, diminish rapidly after the procedure, and in most cases do not persist beyond the first few days post-discharge.
  2. At mid-term follow-up around 22 months, the incidence of NSVT on ambulatory monitoring returned to pre-procedural baseline levels (14%) and no patients experienced major arrhythmic events or sudden death after hospital discharge.
  3. Factors associated with early post-TPVR ventricular arrhythmias included substantial device-myocardial contact, pre-existing rhythm abnormalities, and a diagnosis of pulmonary stenosis or pulmonary atresia with intact ventricular septum.  Most patients started on new antiarrhythmic medications post-procedure were able to discontinue them by 2.5 months.

In this study, Yang et al. examine ventricular arrhythmias in patients undergoing transcatheter pulmonary valve replacement (TPVR) with the Harmony valve.  This study builds upon their prior work evaluating immediate post-procedural arrhythmias and extends follow-up beyond hospital discharge using extended rhythm monitoring (ERM).  

Between September 2017 and February 2024, 54 patients underwent TPVR with the Harmony valve (50% male) with 72% having Tetralogy of Fallot and the rest either pulmonary valve stenosis (PS) or pulmonary atresia with intact ventricular septum (PA-IVS).  Non-sustained ventricular tachycardia (NSVT) and ventricular ectopy were common immediately post-TPVR, occurring in 50% of patients, but were typically infrequent and diminished rapidly.  On discharge ERM, NSVT was detected in 37% but nearly all episodes occurred within the first 5 days.  Only 15% had NSVT beyond 5 days post-discharge.  On follow-up ERM at a median of 22 months, infrequent NSVT was noted in only 14% of patients, like the pre-procedural incidence.  No patients experienced major arrhythmic events after discharge.  Factors associated with early post-procedural NSVT included substantial myocardial contact of the device, pre-existing rhythm abnormalities, and underlying diagnosis of PS/PA-IVS rather than TOF.

This study provides important insights into the natural history of peri-procedural ventricular arrhythmias following Harmony TPVR. Although quite frequent immediately post-implant, these arrhythmias appear to be self-limited in most patients without major clinical sequelae.  The incidence returns to baseline by mid-term follow-up without an apparent increased risk of malignant arrhythmias.  The clinical implications are reassuring for this emerging therapy.  Peri-procedural NSVT, while common, should not necessarily be viewed as a harbinger of poor outcomes and conservative management appears appropriate in most cases.  Antiarrhythmic medications, while frequently initiated, were discontinued in the majority by 2.5 months.

However, important questions remain.  The exact mechanism of these arrhythmias, likely related to contact irritation, requires further study.  Moreover, the lack of apparent clinical impact in the first 1-2 years does not preclude the possibility of device-related pro-arrhythmia emerging over longer-term follow-up. Certain high-risk subsets, such as those with pre-existing VT, may benefit from a more aggressive approach.  

Larger, prospective studies with systematic monitoring protocols and longer-term follow-up are needed to fully delineate the prognostic implications of post-TPVR ventricular arrhythmias.  Nonetheless, the authors should be commended for this detailed arrhythmia assessment which enhances our understanding of this increasingly utilized therapy.  Their data provide a measure of reassurance regarding the early and mid-term risk of malignant arrhythmias following Harmony TPVR.