Long-Term Outcomes of the Coarctation of the Aorta Stent Trials

Abstract

Background: Long-term outcome data of stent-implantation for coarctation of the aorta are limited. We report up to 5 years of postimplant follow-up in patients enrolled into the COAST (Coarctation of the Aorta Stent Trial) and the COAST II trial (Covered Cheatham-Platinum Stents for Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta), evaluating the bare and Covered Cheatham-Platinum Stents for the treatment of coarctation of the aorta and associated aortic wall injury. Methods: Data was prospectively collected during the 2 multi-center studies, enrolling 248 patients (COAST: n=121, COAST II: n=127). Late follow-up data (48–60 month) was compared with immediate (1 month) and early (12 months) follow-up. Results: There was a notable decrease in the use of antihypertensive medication, from 53% at immediate, to 42% at early, and 29% at late follow-up. The cumulative incidence of stent fractures was 0% immediately, 2.9% at early, and 24.4% at late follow-up. Independent predictors for stent fractures at late follow-up were age <18 years, male sex, minimum stent diameter ≥12 mm, and use of bare metal stent. The cumulative incidence of reintervention was 1.6% at immediate, 5.1% at early, and 21.3% at late follow-up. Independent predictors for reinterventions at late follow-up were age <18 years, post implantation systolic arm-leg blood pressure gradient ≥10 mm Hg, minimum stent diameter at implantation <12 mm, and initial coarctation minimum diameter <6 mm. There were 13 patients with aortic aneurysms, with a cumulative incidence of 6.3% at late follow-up. Conclusions: Coarctation stenting is effective at maintaining obstruction relief up to 60 months postimplant with reduction in the number of patients requiring antihypertensive medication. However, an increase in-stent fractures and reinterventions were observed between medium and long-term follow-up. Covered stents appear to confer some protection from the development of stent fractures but do not provide complete protection from late aneurysm formation. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT00552812 and NCT01278303.

German Registry for Cardiac Operations and Interventions in Patients with Congenital Heart Disease: Report 2021 and 9 Years' Longitudinal Observations on Fallot and Coarctation Patients

“…In the future, long-term assessment will become increasingly more important in CHD since the quality of treatment frequently does not become apparent within the first months after the procedure. 20,21 Combined case group analysis provides a real, live description of the time and effort and the performance of surgical and interventional treatment in Germany. 22 Cases planned with single interventions required the least Fig.…”

“…In the future, long-term assessment will become increasingly more important in CHD since the quality of treatment frequently does not become apparent within the first months after the procedure. 20 21 …”

Transcatheter Interventions in Patients With Adult Congenital Heart Disease

“…139 The intermediate results of 1 study demonstrated that 4% of patients with stenting of the CoA underwent an unplanned reintervention because of recurrent coarctation or pseudoaneurysm formation, with an average time to reintervention of 2.84 years, whereas another study found a cumulative aneurysm incidence of 6% at 5 years. 9,139 The availability of covered stents (balloon-expandable or self-expanding) platforms may further improve the safety profile of stents, reduce catastrophic aortic wall injury, and allow the treatment of CoA-associated pseudoaneurysms or aneurysms.…”

“…For example, patients with cyanosis, low muscle mass, or hepatic congestion due to rightheart disease or Fontan circulation have more renal and hepatic dysfunction than is apparent using standard laboratory evaluation and have a higher risk of bleeding. is a powerful quality improvement tool for pediatric and adult congenital cardiac catheterizations 8 ; the other multicenter collaborations include the Congenital Cardiac Interventional Study Consortium 9 and Congenital Cardiac Catheterization Project on Outcomes. 10 Patient heterogeneity, variability in procedural selection and techniques, the need for extensive and detailed data entry, and rapid changes in available technologies have long been a significant challenge in registry and outcome research in ACHD; however, this has been somewhat mitigated by the electronic medical records and increased resources available for quality improvement and research.…”

Challenges in diagnosis and management of coarctation of the aorta

“…Early results of the BeGraft aortic stent in the pediatric population, which has the advantage of large postdilation diameter up to 3 cm and low profile, have been very good, although more data is needed on medium-term to long-term outcomes [44][45][46]. There have also been studies confirming medium-term to long-term outcomes in young infants requiring balloon angioplasty [22] and coarctation patients treated with covered stents [47,48]. In spite of promising outcomes of percutaneous strategies, many studies continued to show a risk for reintervention and arterial hypertension requiring treatment.…”