July

Munich Comparative Study: Prospective Long-Term Outcome of the Transcatheter Melody Valve Versus Surgical Pulmonary Bioprosthesis With Up to 12 Years of Follow-Up

Munich Comparative Study: Prospective Long-Term Outcome of the Transcatheter Melody Valve Versus Surgical Pulmonary Bioprosthesis With Up to 12 Years of Follow-Up View Article Georgiev S, Ewert P, Eicken A, Hager A, Hörer J, Cleuziou J, Meierhofer C, Tanase D.  Circ Cardiovasc Interv. 2020 Jul;13(7):e008963. doi: 10.1161/CIRCINTERVENTIONS.119.008963.PMID: 32600110 Take Home Points: Percutaneous pulmonary valve implantation (PPVI) with the Melody valve is associated with comparable outcomes to those after surgical pulmonary valve replacement (SPVR). Freedom from infective endocarditis (IE) with or without the need for PV reintervention did not differ between the patients treated with PPVI or SPVR. Of those with Melody valve IE, nearly half could be treated with antibiotics only and had preserved valve function following therapy. Commentary from Dr. Arash Salavitabar, (Ann Arbor MI), catheterization section editor of Pediatric Cardiology Journal Watch:  The authors of this manuscript sought to explore the long-term mortality and morbidity after percutaneous pulmonary valve implantation (PPVI) and surgical pulmonary valve replacement (SPVR) by prospectively comparing the long-term outcomes in patients treated with PPVI with the Melody valve (Medtronic, Dublin, Ireland) and SPVR in a single institution. This prospective, single-center study enrolled patients over 12 years (1/2006-12/2018). This study excluded PPVI performed with other types of transcatheter valves and SPVR performed with pulmonary valves £18mm. A percutaneous approach was used if it was deemed technically feasible by evaluation in the catheterization laboratory, and the remaining patients underwent a surgical approach. This center’s referral pattern to a percutaneous approach initially included the classic dysfunctional RV-PA conduits and bioprosthetic valves, but later included patched right ventricular outflow tracts (RVOTs) as well. Echocardiography was the primary imaging modality for following these patients at regular intervals. Primary end points were death and valve requiring re-implantation of a new pulmonary valve. Patients who reached the end point of valve failure were re-entered in the study as a new case with the new valve. Secondary end points were the presence of endocarditis with or without the need for implantation of a new pulmonary valve. This study included 452 patients, 241 in the Melody group and 211 in the SPVR group. Of the SPVR patients, 136 (65%) had homografts, 57 (27%) Hancocks, 11 (5%) Contegra conduits, and 7 (3%) were comprised of other valve types. Patient age and weight were similar between the PPVI and SPVR groups. The PPVI group had smaller labeled pre-implant valve size (22mm (18-22) vs. 23 (18-32), p >0.001), although this could be considered a clinically insignificant difference in many cases. The PPVI group had a significant higher pre-implant mean RVOT gradient, a smaller number of patients with significant pre-implant pulmonary regurgitation, and a shorter overall follow-up period (4.8 years (0.2-11.6) vs. 6.4 years (0.2-12.6), p <0.001). A total of 18 patents died, with no significant difference between the two groups (7 PPVI [2.9% mortality rate], 11 SPVR [5.2% mortality rate]). Two of the PPVI and 3 of the SPVR patient deaths were early in the post-procedural periods. A combined 42 patients reached valve failure, with 18 PPVI patients and 24 SPVR patients requiring replacement of their valves. There was no statistical difference in freedom from valve replacement between the 2 groups at 10 years (Melody group, 80%; SPVR group, 73%; P=0.46). A total of 24 infective endocarditis (IE) cases were diagnosed (18 PPVI, 6 SPVR). Surgical treatment was required in 10 PPVI and 4 SPVR patients, with the remaining receiving antibiotics with preserved valve function. There were no deaths secondary to IE. The annualized incidence of IE was 1.6% in the Melody group and 0.5% in the SPVR group. The annualized incidence of valve replacement due to IE was 0.9% in the Melody group and 0.3% in the SPVR group. There was no statistical difference in survival free of IE at 10 years (PPVI, 82%; SPVR, 86%; p=0.082), survival free of PVR because of IE (PPVI, 88%; SPVR, 88%; p=0.35). The survival rate free of PVR, no associated with IE, was also not different between the two groups (Melody group, 91%; SPVR group, 75%; p=0.082). The authors admit that their data was limited by the nonrandomized nature of this study. In addition, the Edwards Sapien XT and Sapien 3 valves were not included in this analysis, which are valuable, contemporary additions to the PPVI options in the cardiac catheterization laboratory. However, the prospective design of this study is a valuable addition to the existing data comparing Melody valve PPVI to surgical PVR.

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Outcomes After Transcatheter Reintervention for Dysfunction of a Previously Implanted Transcatheter Pulmonary Valve

Outcomes After Transcatheter Reintervention for Dysfunction of a Previously Implanted Transcatheter Pulmonary Valve View Article 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. PMID: 32646693 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).

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Munich Comparative Study: Prospective Long-Term Outcome of the Transcatheter Melody Valve Versus Surgical Pulmonary Bioprosthesis With Up to 12 Years of Follow-Up

Munich Comparative Study: Prospective Long-Term Outcome of the Transcatheter Melody Valve Versus Surgical Pulmonary Bioprosthesis With Up to 12 Years of Follow-Up View Article Georgiev S, Ewert P, Eicken A, Hager A, Hörer J, Cleuziou J, Meierhofer C, Tanase D.  Circ...

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Echocardiographic two-dimensional speckle tracking identifies acute regional myocardial edema and sub-acute fibrosis in pediatric focal myocarditis with normal ejection fraction: comparison with cardiac magnetic resonance

Echocardiographic two-dimensional speckle tracking identifies acute regional myocardial edema and sub-acute fibrosis in pediatric focal myocarditis with normal ejection fraction: comparison with cardiac magnetic resonance View Article Chinali M, Franceschini A,...

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