Assistant Professor of Pediatrics/Cardiac Intensivist/Division of Pediatric Cardiology Children's Healthcare of Atlanta BROOKHAVEN, Georgia, United States
Abstract:
Background: The FDA approved a 15-mm mechanical valve for pediatric use in March of 2018. Reports with this device are quite limited. We review our center's operative and postoperative experience with this valve in children.
Methods: We performed a retrospective chart review to identify 15-mm MVRs between 2009 and 2022 and analyzed short and long-term outcomes using descriptive statistics.
Results: Fifteen patients underwent 16 MVRs (one repeat) with no operative deaths. The median age and weight at the time of operation were 6 months (4.2-18.5) months and 5.16 kg (4.4-8.0), respectively. Ten patients (67%) had undergone mitral valve repair in a prior operation. Nine patients (60%) were in the Cardiac intensive care unit (CICU) prior to surgery; six (40%) were mechanically ventilated. Twelve implants (80%) were placed in the supra-annular position. Post-operative length of intubation was 1 (0.75-4) day, CICU length of stay (LOS) was 6 (3-17) days and overall hospital LOS was 16.5 (12-52) days. Three patients experienced 6 post-operative major adverse events. There were no episodes of thromboembolic events or heart block as a result of 15-mm MVR. Six patients (40%) had early readmission related to anticoagulation issues. There were no surgical mortalities, however, four late deaths occurred (27%), with 3 of the 4 in the setting of pulmonary hypertension (PH). Five patients have undergone subsequent MVR with a median time to second MVR of 6 (2-7.5) years. There are 6 patients with their original 15-mm MVR at a median time of 5.5 years since placement, including two patients who are 11 and 9 years postop from MVR.
Conclusion: We present the largest single-center cohort of patients having undergone 15mm MVR. Distinguished by the predominant placement in the supra-annular position, this report demonstrates greater longevity and durability of the device than prior reports. Pulmonary hypertension is a major contributor to mortality despite the technical success of MVR. Further investigation is warranted to determine the optimal timing of initial and subsequent MVR and identification of modifiable factors contributing to morbidity and mortality.