Angioplasty of Obstructed Homograft Conduits in the Right Ventricular Outflow Tract With Ultra-Noncompliant Balloons

Hainstock, Michael; Marshall, Audrey C.; Lock, James E.; McElhinney, Doff B.

doi:10.1161/circinterventions.112.000073

Cited by 30 publications

(21 citation statements)

References 22 publications

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“…A conduit tear or injury with predilation or prestenting was uncommon in this cohort, with only 4% (5 patients) experiencing confined tears before TPVR, which is lower than reported in previous studies in which the rates of conduit injury ranged from 6% to 33%. 18,23 There were no instances of unconfined or catastrophic tears of the conduit.…”

Section: Discussionmentioning

confidence: 94%

“…Conduit disruption or injury was defined as confined (contrast extravasation >3 mm beyond the lumen but with no extension into the pericardial or pleural space) or unconfined (contrast extravasation into the pericardial or pleural space). 18 Mild-to-moderate conduit calcification was defined as incomplete circumferential calcium deposits on fluoroscopy, whereas severe calcification was defined as complete, dense circumferential calcium deposits on fluoroscopy. Follow-up events included the development of TPV stent fractures, the occurrence of IE, and RVOT reintervention.…”

Section: Discussionmentioning

confidence: 99%

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Multicenter Experience Evaluating Transcatheter Pulmonary Valve Replacement in Bovine Jugular Vein (Contegra) Right Ventricle to Pulmonary Artery Conduits

Morray

McElhinney

Boudjemline

et al. 2017

Circ: Cardiovascular Interventions

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The majority of Melody valves implanted early in the experience were within cryopreserved homograft conduits. A relatively common alternative to homograft conduits for RVOT reconstruction is the Contegra pulmonary valve conduit, a glutaraldehyde-preserved bovine jugular vein conduit (Medtronic, Inc), which is available in a range of sizes (12-22 mm) for use Background-Follow-up of transcatheter pulmonary valve replacement (TPVR) with the Melody valve has demonstrated good short-term and long-term outcomes, but there are no published studies focused on valve performance in the Contegra bovine jugular vein conduit. Methods and Results-This is a retrospective, multicenter study of the short-and intermediate-term outcomes of Melody TPVR within the Contegra conduit in the right ventricle to pulmonary artery position. Data from 13 centers were included in the analysis. During the study period, 136 patients underwent 139 catheterizations for attempted Melody TPVR with a median follow-up of 3 years (1 day to 9.1 years). Of the 136 patients, 117 underwent successful Melody TPVR. Two patients underwent a second Melody TPVR. The majority of patients underwent placement of ≥1 stents before transcatheter pulmonary valve implantation. There was a significant reduction in peak conduit pressure gradient acutely after transcatheter pulmonary valve implantation (39 versus 10 mm Hg; P<0.001). At most recent follow-up, the maximum pulmonary valve gradient by echocardiogram remained significantly reduced relative to prevalve implant measurements (65.9 versus 27.3 mm Hg; P<0.001). The incidence of Melody transcatheter pulmonary valve stent fracture (3.4%) and infectious endocarditis (4.3%) were both low. Serious adverse events occurred in 3 patients. Conclusions-Melody TPVR in Contegra conduits is safe and effective and can be performed in a wide range of conduit sizes with preserved valve function and low incidence of stent fracture and endocarditis. (Circ Cardiovasc Interv.

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Section: Discussionmentioning

confidence: 94%

Section: Discussionmentioning

confidence: 99%

Multicenter Experience Evaluating Transcatheter Pulmonary Valve Replacement in Bovine Jugular Vein (Contegra) Right Ventricle to Pulmonary Artery Conduits

Morray

McElhinney

Boudjemline

et al. 2017

Circ: Cardiovascular Interventions

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“…The rate of conduit disruption in this study is similar to reported rates in other studies which have ranged from 6 to 22%. 12,18,19 At 6-month and 1-year follow-up, there were no reports of stent fracture or endocarditis.…”

Section: Discussionmentioning

confidence: 98%

“…Sponsor assessment of adverse event relationships was also done, with final determination left to the physician. While the study did not specifically define conduit disruption or injury, cases identified align with that defined in a previous report as confined (contrast extravasation >3 mm beyond the lumen but with no extension into the pericardial or pleural space) or unconfined (contrast extravasation into the pericardial or pleural space) . Stent fractures were characterized according to protocol definitions based on published guidelines: type 1, stent fracture with no loss of stent integrity; type 2, stent fracture with loss of stent integrity; type 3, stent fracture associated with embolization of stent fragments .…”

Section: Methodsmentioning

confidence: 99%

Implantation of the Melody transcatheter pulmonary valve PB1016 in patients with dysfunctional right ventricular outflow tract conduits

Morray

Jones

Coe

et al. 2018

Cathet Cardio Intervent

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Objectives This study describes procedural and 1‐year outcomes of the 16 mm Melody PB1016 valve in patients with dysfunctional RVOT conduits. Background The Melody PB1016 is a standard Melody valve produced from a 16 mm bovine jugular vein and is intended for deployment up to 20 mm. Methods This is a prospective, non‐randomized, multicenter study of the procedural and short‐term outcomes of Melody PB1016 TPV replacement within dysfunctional RVOT conduits. Data from eight centers were included in the analysis. Results During the study period, 39 patients underwent attempted Melody TPVR. Of the 39 patients, 30 underwent successful Melody TPVR. The majority of patients underwent placement of one or more stents prior to TPVR. There was a significant reduction in peak conduit pressure gradient following TPVR (38 mmHg vs. 11 mmHg, P < 0.001). There were three cases of confined conduit tears successfully treated with covered stents or the valve itself. Repeat catheterization was performed in one patient for early re‐obstruction that was successfully treated with balloon valvuloplasty. At recent follow‐up, there were no cases of more than mild valve regurgitation and the mean pulmonary valve gradient by echocardiogram remained reduced relative to pre‐TPVR implant measurements (33.5 mmHg vs. 15.2 mmHg). There were no cases of valve stent fracture or endocarditis reported at the 1‐year follow‐up. Conclusions Our analysis of TPVR with the PB1016 valve in RVOT conduits showed it to be safe and effective and can be performed in a wide range of conduit sizes with preserved valve function. https://ClinicalTrials.gov Identifier: NCT02347189.

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“…In a minority of cases. the resulting tear can extend into a free thoracic space (e.g., pericardial or pleural space), resulting in a rupture . RVOT conduits, often homografts, may exhibit similar tears, although the in situ remodeling that they undergo tends to eliminate the native arterial tissue layers .…”

Section: Discussionmentioning

confidence: 99%

Iatrogenic aortopulmonary communications after transcatheter interventions on the right ventricular outflow tract or pulmonary artery: Pathophysiologic, diagnostic, and management considerations

Torres

Sanders

Vincent

et al. 2015

Cathet Cardio Intervent

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Angioplasty of Obstructed Homograft Conduits in the Right Ventricular Outflow Tract With Ultra-Noncompliant Balloons

Cited by 30 publications

References 22 publications

Multicenter Experience Evaluating Transcatheter Pulmonary Valve Replacement in Bovine Jugular Vein (Contegra) Right Ventricle to Pulmonary Artery Conduits

Multicenter Experience Evaluating Transcatheter Pulmonary Valve Replacement in Bovine Jugular Vein (Contegra) Right Ventricle to Pulmonary Artery Conduits

Implantation of the Melody transcatheter pulmonary valve PB1016 in patients with dysfunctional right ventricular outflow tract conduits

Iatrogenic aortopulmonary communications after transcatheter interventions on the right ventricular outflow tract or pulmonary artery: Pathophysiologic, diagnostic, and management considerations

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