Covered CP Stent for Treatment of Right Ventricular Conduit Injury During Melody Transcatheter Pulmonary Valve Replacement.

BACKGROUND: High-pressure balloon and stent angioplasty are frequently necessary to prepare the dysfunctional right ventricular outflow tract conduit before transcatheter pulmonary valve replacement (TPVR). Conduit injury can result, which may be catastrophic to the patient or prevent successful TPVR. METHODS AND RESULTS: The PARCS trial (Pulmonary Artery Repair With Covered Stent) was a pivotal, prospective multicenter trial to evaluate the safety and efficacy of the NuMED Covered CP Stent (CCPS) for treatment of conduit injury occurring during TPVR. The study also evaluated immediate and short-term TPVR function in patients receiving covered stents. A total of 616 patients were consented; 120 (19.5%) had a wall injury identified and were treated with CCPS. Severe conduit injuries were uncommon (5%), but predictors for severe injury were not identified. Stenotic homografts had the highest incidence of injury (29%), compared with other conduit substrates. Among patients receiving CCPS implant, 96% required no further therapy for conduit injury, and 94% underwent TPVR at that procedure. Only 2 patients (1.6%) required urgent surgery for conduit injury, despite CCPS implant. There were few CCPS-related complications. TPVR function was similar between CCPS and non-CCPS groups at follow-up. CONCLUSIONS: Conduit injury during TPVR is common, although severe injury is rare. The CCPS was a safe and effective treatment for right ventricular outflow tract conduit injury during preparation for TPVR, allowing nearly all patients to complete the procedure without identifiable impact on valve performance. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01824160.

NuMED Covered Cheatham-Platinum Stent™ for the treatment or prevention of right ventricular outflow tract conduit disruption during transcatheter pulmonary valve replacement.

OBJECTIVE: Retrospectively assess the frequency of right ventricular outflow tract (RVOT) conduit disruption during transcatheter pulmonary valve replacement (TPVR) and the effectiveness and safety of NuMED Covered Cheatham-Platinum Stents™ (CCPS) for its prevention or treatment. BACKGROUND: There have been no published reports to date describing the safety and effectiveness of covered stents to prevent or treat RVOT conduit disruption during TPVR. METHODS: Data regarding 251 TPVR procedures performed at multiple US investigational sites were retrospectively reviewed to explore the incidence and potential predictors of conduit disruption. In addition, data on the use of 69 CCPS implanted in 50 patients during TPVR was reviewed. RESULTS: The overall incidence of conduit disruption requiring intervention was 6%. The only predictor identified was a very elevated RVOT conduit systolic pressure gradient. A pre-existing conduit tear was present in nine, while 31 developed tears after conduit dilation and three, after TPVR. The CCPS was used prophylactically in seven. Conduit tears were prevented or repaired in 49/50 patients. No CCPS-related acute complications were reported. At 6-month follow-up, no patient had more than mild pulmonary regurgitation and the mean Doppler RVOT gradient (12.7 ± 5.8 mm Hg) comparing favorably with that reported in the Melody TPV® IDE trial (20.0 ± 8.6 mm Hg). CONCLUSION: CCPS implantation can successfully treat RVOT conduit disruption without negative impact on the TPV function. This retrospective analysis suggests high RVOT conduit systolic pressure gradient is a risk factor for conduit tears during TPVR.

Device closure of secundum atrial septal defects in infants weighing less than 8 kg.

This study aimed to assess the technical aspects of atrial septal defect (ASD) closure using the Amplatzer septal occluder (ASO) and the Gore Helex septal occluder (GHSO) for infants weighing less than 8 kg and to determine the safety, effectiveness, and near-to-intermediate-term outcome of the closure. The Mid-Atlantic Group of Interventional Cardiology Registry of percutaneous, transcatheter ASD closure procedures was reviewed for this analysis. Patients from 10 hospitals in the United States were included. The cohort for this report consisted of 68 patients weighing less than 8 kg (range, 2.3-7.8 kg; mean, 5.5 ± 1.6 kg) and ranging in age from 1 to 24 months (mean, 8.6 ± 4.7 months). The indications for ASD closure were failure to thrive, significant right heart enlargement, shunts otherwise thought to be hemodynamically significant, and poor overall clinical status. Devices were successfully implanted in 66 of the 68 infants (97.1 % procedural success rate). Five minor procedure-related complications occurred. At follow-up assessment, clinical status had improved significantly as measured by improved weight gain and decreased ventilator or oxygen dependence. All residual shunts spontaneously closed during the follow-up period. Six late deaths occurred, none of which were clearly device related. The ASO and GHSO can be safely and effectively implanted for ASD closure in infants weighing less than 8 kg. These procedures usually are successful and seldom complicated, resulting in significant clinical improvement.

Unusual sudden cardiac death from an anomalous left coronary artery from the right sinus of Valsalva.

A left coronary artery arising from the right sinus of Valsalva is a rare congenital coronary anomaly. We report a case of a 5-year-old boy with an anomalous left coronary artery from the right sinus of Valsalva whose presenting sign was cardiac arrest. There is no reported instance of a child <9 years of age without other congenital cardiac defects having died suddenly with this coronary anomaly. The transthoracic echocardiogram demonstrated normal origins of the coronary arteries, but on autopsy, an anomalous origin of the left main coronary artery from the right sinus of Valsalva was found.