Researchers found a significant amount of practice variation when it came to transcatheter valvuloplasty in children, reporting in a registry study that a substantial number of U.S. cases were not done in accordance with current guidelines.
Patients having a high resting gradient made up 82% of the stated indications for balloon aortic (BAV) and pulmonary valvuloplasty (BPV) from 2011-2015 recorded in the IMPACT registry. Among these interventions, 86% of BAVs and 66% of BPVs were consistent with guideline recommendations published in 2011, which is to say that the pre-treatment gradient was at least the guideline-specified value, according to Andrew Glatz, MD, of the Children’s Hospital of Philadelphia, and colleagues.
Interhospital variation for BAV missed statistical significance (median rate ratio 1.8, 95% CI 1.0-2.3). However, hospitals in the East and South more likely to perform the procedure in accordance with the 2011 guidelines than those in the Midwest and West, they wrote in JACC: Cardiovascular Interventions.
For BPV, no hospital-level factors were tied to guideline-consistent practice, yet there was a significant amount of interhospital variation that was not explained by patient- or procedure-level characteristics (median RR 1.4, 95% CI 1.2-1.6).
Glatz’s group said that they had suspected there was some practice variation despite BAV and BPV being “well-established procedures” in congenital interventional cardiology.
“That these variations exist is beyond dispute. Whether the variations identified constitute evidence of gaps in quality of care is another thing,” commented Thomas Jones, MD, of Seattle Children’s Hospital, in an accompanying editorial.
He questioned the validity of the published thresholds of care in the guidelines.
“A close examination of the evidence used to establish treatment guidelines for balloon valvuloplasty intervention in both congenital aortic and pulmonary valve stenosis reveals that the threshold for treatment is based largely upon surgical outcomes defined more than 40 years ago,” according to Jones. “No specific studies have ever been performed to define a threshold for intervention on the basis of outcomes for either BAV or BPV. Instead, criteria established largely in the surgical era have been applied to percutaneous interventions.”
Ultimately, that the field of pediatric and congenital interventional cardiology treats patients with relatively uncommon conditions is a challenge for research and guideline-writing, the editorialist suggested.
The present IMPACT registry analysis included BAV (n=1,071) and BPV cases (n=2,207) across dozens of centers in the U.S. in a mostly pediatric cohort. It was a limitation that there were no pre-intervention gradients recorded in the database, any information on resource utilization, nor longitudinal follow-up for outcomes.
“The numbers of patients undergoing BAV and BPV treatments far exceed any prior population studies published,” Jones maintained.
Even so, he wrote, “the ability to define thresholds for intervention will require longitudinal follow-up of both treated and untreated patients. This may be a tall order but is a worthy undertaking.”
The study was funded by the American College of Cardiology and National Cardiovascular Data Registry.
Glatz disclosed support from the Children’s Heart Foundation, the CHD Coalition, and Big Hearts to Little Hearts.
Jones disclosed support from and relevant relationships with Medtronic, W. L. Gore & Associates, and Abbott.