Covered Stent Correction for Sinus Venosus Atrial Septal Defects, an Emerging Alternative to Surgical Repair: Results of an International Registry

Abstract

Background: Covered stent correction for a sinus venosus atrial septal defect (SVASD) was first performed in 2009. This innovative approach was initially viewed as experimental and was reserved for highly selected patients with unusual anatomic variants. In 2016, increasing numbers of procedures began to be performed, and in several centers, it is now offered as a standard of care option alongside surgical repair. However, covered stent correction for SVASD is not recognized by regulatory authorities, and in the minds of many pediatric and adult congenital cardiologists and surgeons, the condition is viewed as treatable only by cardiac surgery with cardiopulmonary bypass.

Methods: In April 2023, all centers identified from international conferences, publications, and colleague networks to be undertaking covered stent correction for SVASD were invited to participate in a retrospective audit of their procedures.

Results: Data were received on 381 patients from 54 units over a 12-year period with 90% of procedures being performed over the past 5 years. Balloon-expandable stents (8 types) were used in the majority; self-expanding stents (4 types) were used in 4.5%. The commonest stent was the 10-zig covered Cheatham Platinum stent in 62% of cases. In 10 procedures, the stent embolized requiring surgical retrieval and repair of the defect, resulting in technically successful implantation in 371 of 381 (97.4%). Major complications (surgical drainage of tamponade, pacemaker implantation, surgery for pulmonary vein occlusion, and late stent removal) occurred in 5 patients (1.3%). Repeat catheterization to correct residual leaks was required in 7 patients (1.8%). Thus, 359 of 381 patients (94.2%) had successful correction without major complications or additional catheter interventions.

Conclusions: This article details the exponential uptake of covered stent correction for SVASD during the past 5 years. Cardiopulmonary bypass was avoided in the majority of patients, and major complications were infrequent. Prospective registries with standardized definitions, inclusion criteria, and follow-up and comparative studies with surgery are now required to help support the extension of covered stent correction as an alternative standard-of-care option for patients with an SVASD.

Keywords: atrial septal defect sinus venosus; stents.

Figure 1.

Study enrollment. Study enrollment flowchart showing the majority of procedures were undertaken by 11 of 12 of the centers from the original 10-zig Covered Cheatham Platinum (CCP) Registry. The 43 new centers contributed 39% of the procedures. Of 390 known patients, data were submitted on 381.

Figure 2.

Number of procedures by year and by center. The yearly number of procedures is shown by the blue bars; total number of centers undertaking procedures is shown by the orange bars in A. Only 8 months of data are available in 2023. The number of cases and centers is shown in B.

Figure 3.

World uptake of covered stent correction for sinus venosus ASDs. The color-coded graphic shows the world uptake of the procedure and the large parts of the world that have not yet undertaken procedures (https://datawrapper.dwcdn.net/0BIJU/1/). Actual case numbers are given in Table S1. ASD indicates atrial septal defect.

Figure 4.

Stents. Stents used included 10-zig covered CP (Numed Inc, Hopkinton, NY; A), *10-zig G-Armor (uncovered in illustration) stent (Numed; B),† B-graft (Bentley InnoMed GmbH, Germany; C),‡ covered Andrastent (Andramed GmbH, Reutlingen, Germany; D),§ Optimus Covered Stent (AndraTec GmbH, Koblenz, Germany; E),‖ Zephyr covered stent (Sahajan and Laser Technology Ltd, India; F),¶ Zenith Flex (Cook Medical, Bloomington, IN; G),# Endurant Stentgraft (Medtronic, Minneapolis, MN; H),** VB Stent (HeartX, Galway, Ireland; I),†† and Nano Self-Expanding Stent (Nano, Florianopolis, Brazil; J). The 8-zig versions of A and B are not shown. *Modified from Rosenthal E, Qureshi SA, Jones M, Butera G, Sivakumar K, Boudjemline Y, Hijazi ZM, Almaskary S, Ponder RD, Salem MM, et al. Correction of sinus venosus atrial septal defects with the 10 zig covered Cheatham-platinum stent: an international registry. Catheter Cardiovasc Interv. 2021;98:128–136. †Modified from Morgan GJ, Zablah J. A new FDA-approved stent for congenital heart disease: first-in-man experiences with G-ARMORTM. Catheter Cardiovasc Interv. 2022;100:1261–1266. ‡Modified from Bentley receives CE mark for new BeGraft aortic stent graft. Vascular News. https://vascularnews.com/bentley-receives-ce-mark-for-new-begraft-aortic/. Modified from Andramed GmbH. https://andramed.com. ‖Modified from Haddad RN, Hascoet S, Karsenty C, Houeijeh A, Baruteau AE, Ovaert C, Valdeolmillos E, Jalal Z, Bonnet D, Malekzadeh-Milani S. Multicentre experience with Optimus balloon-expandable cobalt-chromium stents in congenital heart disease interventions. Open Heart. 2023;10:e002157. ¶Modified from Sagar P, Puthiyedath T, Sivakumar K. First-in-man use of an Indian-made balloon-expandable covered Zephyr stent and intermediate-term follow-up. Ann Pediatr Card. 2023;16:48–51. #Modified from Illig KA, Ohki T, Hughes GC, Kato M, Shimizu H, Patel HJ, Shahriari A, Mehta S; Zenith TX2 Low Profile Study Investigators. One-year outcomes from the international multicenter study of the Zenith Alpha Thoracic Endovascular Graft for thoracic endovascular repair. J Vasc Surg. 2015;62:1485–1494. **Modified from Yalamanchi R, Sivaprakasam MC, Janke RVR, Chandrasekharan K, Sadhasivam VS, Showkathali R. Unanticipated complication of transcatheter correction of superior sinus venosus atrial septal defect. J Cardiol Cases. 2021;25 99–102. ††Modified from Vettukattil J, Subramanian A, Barthur A, Mahimarangaiah J. Transcatheter closure of sinus venosus defect: first-in-human implant of a dedicated self-expanding VB stent system. Catheter Cardiovasc Interv. 2023;102:1088–1094.