BOSTON -- The first registry study to compare percutaneous versus surgical repair of post-infarction ventricular septal defect (VSD) found upfront differences in survival that have an unclear impact on long-term outcomes.
Based on a few hundred cases, 5-year all-cause mortality was approximately 60% between patients assigned an initial management strategy of surgery and those undergoing percutaneous treatment (log-rank P=0.059). Despite in-hospital mortality rates putting the percutaneous group at a significant disadvantage initially (55.0% vs 44.2%, P=0.048), landmark analysis from hospital discharge revealed no long-term differences in survival.
Nevertheless, upon multivariable adjustment, cardiogenic shock was the strongest predictor of 5-year mortality (adjusted HR 1.97, 95% CI 1.37-2.84), followed by percutaneous management (adjusted HR 1.44, 95% CI 1.01-2.05) in the retrospective analysis, according to Joel Peter Giblett, MD, of Liverpool Heart and Chest Hospital in England.
Selection bias may have been at play given that some patients were only offered percutaneous treatment once surgical repair was deemed unfeasible, he cautioned during a presentation at the Transcatheter Cardiovascular Therapeutics (TCT) meeting hosted by the Cardiovascular Research Foundation.
"Both percutaneous and surgical management are complementary in real-world clinical practice and offer significant survival advantage compared to historical data on medical therapy," Giblett stated. "Shared decision-making through the heart team is key for patients."
He said that when study results were shared with site investigators, most concluded that timing trumps the question of repair method -- that having someone close by to do an operation quickly is the preference over waiting around for the patient to deteriorate.
The choice between percutaneous and surgical management of VSD should depend on the local situation of each hospital and whether they have experienced operators for either approach, agreed TCT session panelist Horst Sievert, MD, of Cardiovascular Center Frankfurt CVC.
A rare but life-threatening complication of acute myocardial infarction (MI), a VSD is a new tear between the left and right ventricles exposing the latter to systemic pressures. Left alone without repair, mortality exceeds 94% at 1 month with medical therapy alone, Giblett said.
He reported that the incidence of device embolization reached 7.6% with the percutaneous approach in the registry.
At a TCT press conference, Ralph Stephan Von Bardeleben, MD, of Universitätsmedizin Heart Valve Center Mainz in Germany, suggested that innovative hybrid procedures -- wherein operators suture occluder devices into the septum -- show promise at eliminating the risk of device embolization.
Even so, post-MI VSD patients are an "incredibly difficult population to study and treat" as not all defects are created equally, and can be difficult to image, maintained Michael Young, MD, of Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire.
For the study, Giblett's group relied on a U.K. national registry that included data from 16 sites. It is the largest registry of percutaneous post-infarct VSD cases to date.
Participants were split between heart attack survivors undergoing surgical repair (n=230) or percutaneous (n=131) as their initial treatment for a post-MI VSD in 2010-2021.
Compared with the surgical cohort, the percutaneous group was older (72 vs 67, P<0.001) and trended toward a greater proportion of women (35.1% vs 25.1%, P=0.167). These patients were also more likely to present with MIs in the anterior versus inferior region but less likely to have cardiogenic shock (51.9% vs 62.8%, P=0.044).
Patients in both cohorts waited a median 2 days from acute MI to presentation, and 9 days from acute MI to VSD repair.
Following intervention, percutaneous management was associated with fewer procedural strokes (0.8% vs 5.6%, P=0.021), new pacemakers and implantable cardioverter-defibrillators implanted (1.5% vs 6.9%, P=0.023), and pneumonia (8.4% vs 23.4%, P<0.001). On the other hand, surgical management resulted in fewer repeat VSD interventions (21.4% vs 9.1%, P<0.001).
Notably, a longer delay from acute MI to VSD repair was a marginal predictor of lower 5-year mortality (adjusted HR 0.99, 95% CI 0.98-0.99).
TCT press conference co-moderator David Cohen, MD, MSc, of Saint Francis Hospital in Roslyn, New York, warned that it's "almost impossible to do this straight comparison" as surgeons will typically delay VSD repair to make the area more sturdy when they operate, and patients who survive the delay are likely the healthier ones who may be expected to have better long-term outcomes.
The available dataset also suggested fewer VSDs managed surgically or percutaneously early on during the pandemic, raising the question of whether fewer people presented with them or simply avoided the operating room during that time, Giblett said.
He urged that prospective studies be performed to identify the optimal method and timing of VSD management. A randomized trial should be undertaken but it would be difficult and take many years, he acknowledged.
Disclosures
Giblett disclosed no relationships with industry.
Sievert disclosed institutional relationships with 4tech Cardio, Abbott, Ablative Solutions, Adona Medical, Akura Medical, Ancora Heart, Append Medical, Axon, Bavaria Medizin Technologie GmbH, BioVentrix, Boston Scientific, Cardiac Dimensions, Cardiac Success, Cardimed, Cardionovum, Celonova, Contego, Cor; Hangzhou Nuomao Medtech, Holistick Medical, InterShunt, Intervene, K2, Laminar, Lifetech, Magenta, Maquet Getinge Group, Metavention, Mitralix, Mokita, Neurotronics, NXT Biomedical, Occlutech, Recor, Renal Guard, Shifamed, Terumo, Trisol, and Vascular Dynamics.
Von Bardeleben disclosed relationships with Abbott Vascular, Edwards Lifesciences, Medtronic, and NeoChord.
Young disclosed a relationship with Medtronic.
Primary Source
Transcatheter Cardiovascular Therapeutics
Giblett J, et al "Percutaneous or surgical treatment of post infarction VSD: the UK national registry" TCT 2022.