NEW YORK (Reuters Health) – Transcatheter patent ductus arteriosus (PDA) occlusion is technically feasible in infants, but risks for major adverse events are high, particularly for the very young and those who weigh <6 kg (13.2 pounds), researchers say.
“The ductus arteriosus is an essential component of the fetal circulation and normally closes shortly after birth in term infants, but ductal patency persists in about 70% of extremely premature infants and is associated with adverse health outcomes,” Dr. Carl Backes of Nationwide Children’s Hospital, Columbus, Ohio, told Reuters Health.
“Recent advances in pediatric interventional cardiology have provided a nonsurgical alternative to close the PDA,” he explained by email. “While catheter-based occlusion of the PDA is among the safest of interventional cardiac procedures in older children and adults, use among lower-weight infants (<6 kg) has not been characterized adequately.”
To investigate, Dr. Backes and colleagues searched the IMPACT Registry and identified 747 infants (59% female, 60% Caucasian) weighing less than less than 6 kg who underwent transcatheter PDA occlusion from 2011 to 2015. Infants were categorized by age (<30 days vs. 30 days or older) and weight: extremely low weight (<2 kg), very low weight (2 kg to <4 kg), and low weight (4 kg to <6 kg).
As reported online August 16 in JACC: Cardiovascular Interventions, 705 (94.3%) of 747 attempted PDA closures resulted in successful implantation of a device or coil. Rates of procedural failure did not differ significantly by infant weight (roughly 6% in all weight groups) or age (<30 days old, 7.1%; 30 days or older, 5.8%).
PDA minimal lumen diameters were significantly larger in cases of procedural failure than in successful cases (3.6 mm vs. 2.9 mm), but success versus failure was not associated with the diameter of the ductus on the aortic end, ductus length, or use of a coil versus a device.
Failure was more common among infants with primary hypertension (versus other indications for PDA closure) and was associated with higher pulmonary artery systolic pressures.
Ninety-four infants (about 13%) experienced a major adverse event, most commonly acute arterial injury (3.5%) and device embolization requiring retrieval (2.4%). The risk of embolization was higher among extremely-low-weight infants (10.5%) than in very-low-weight (1.6%) or low-weight (2.5%) infants.
Younger age (<30 days) more than tripled the risks of a major adverse event and composite failure.
Dr. Backes concluded, “The present findings are intended to inform patient selection and procedural approach for percutaneous PDA closure and direct targeted research efforts to support the practice of evidence-based medicine. It is important to note, however, that the fundamental question of whether closing or not closing the PDA improves outcomes remains unanswered.”
Dr. Robert Jaquiss, Co-Director of the Heart Center at Children’s Health and professor at UT Southwestern Medical Center, Dallas, told Reuters Health, “The results should give reassurance to parents and referring physicians that non-surgical closure of a PDA can be attempted in even very small infants with a high likelihood of success.”
“The procedure is not without risks, but the risks are generally very low,” he said by email. “Overall, the procedure compares very favorably with the traditional surgical approach for children over 2 kg and older than 30 days.”
“The only caveat is that for the smallest and youngest patients, the procedure is has its greatest risk and lowest likelihood of success,” he noted. “For children at the smallest and youngest end of the spectrum . . . surgical closure of the PDA will still likely remain the procedure of choice if mechanical (non-medical) closure is required.”
SOURCE: http://bit.ly/2vYBg2s
JACC Cardiovasc Interv 2017.
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