Outcomes After Transcatheter Reintervention for Dysfunction of a Previously Implanted Transcatheter Pulmonary Valve
Shahanavaz S, Berger F, Jones TK, Kreutzer J, Vincent JA, Eicken A, Bergersen L, Rome JL, Zahn E, Søndergaard L, Cheatham JP, Weng S, Balzer D, McElhinney D.
JACC Cardiovasc Interv. 2020 Jul 13;13(13):1529-1540. doi: 10.1016/j.jcin.2020.03.035.
Take Home Points:
- Reintervention (balloon dilation alone or implant of an additional Melody valve) on previously implanted Melody valves is feasible.
- Implant of a second Melody valve was more durable compared to balloon dilation alone.
Commentary from Dr. Konstantin Averin (Edmonton), catheterization section editor of Pediatric Cardiology Journal Watch: Transcatheter pulmonary valve replacement (TPVR) is an important component in the lifelong management of patients with right ventricular outflow tract (RVOT) obstruction. The first Melody valve was implanted 20 years ago and has demonstrated a 10-year freedom from reintervention rate of 61%. Despite this excellent durability many patients will require repeat interventions for recurrent obstruction or regurgitation. Limited data exist on the outcomes associated with repeat percutaneous intervention in patients with existing Melody valve. The authors sought to assess technical and procedural factors and outcomes following post-TPVR transcatheter RVOT interventions using pooled data from 3 prospective multicenter Melody valve trials.
A total of 309 patients underwent TPVR with the Melody valve from 2007-2013 as part of the 3 early trials included. Over a median follow up of 5.1 years 46 patients underwent reinterventions, primarily for RVOT obstruction and endocarditis (median age 16 yrs. [7-49], median weight at initial TPVR 61 kgs [27-147]) – 28 had a second Melody implanted (valve in valve [VIV]) and 17 had the original valve dilated. There were expected reductions in peak RVOT gradient, RV systolic pressure, and RV/aortic pressure ratio in both the VIV and dilation alone groups, but those in the dilation group were not statistically significant. There were no significant procedural complications.
After a median follow up of 3.4 years (Q1-Q3: 1.9 – 5.2) 20 patients underwent a second reintervention and 3 patients had the conduit explanted within 3 months of the initial reintervention which was intended as a temporizing measure in the setting of endocarditis. Notably, 60% of patients who underwent balloon angioplasty as the initial reintervention required second reintervention. At 4 years the overall freedom from reintervention was 60% and freedom from explant 83% (see Kaplan Meier curve below).
Reassuringly (and not unexpectedly) the authors conclude that VIV Melody implant is an effective and durable treatment for Melody valve dysfunction. The durability of balloon angioplasty alone may be limited, and strong consideration should be given to bare metal stent with VIV implant. Combined with recent data suggesting that surgical conduits can be safely dilated to at least 125% of their initial diameter (or larger) even patients with smaller conduits may be able to avoid surgical reoperation via repeat interventions with implantation of larger TPVRs (Melody or others).