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

Circulation. 2024 Dec 19. doi: 10.1161/CIRCULATIONAHA.124.070271. Online ahead of print.

Eric Rosenthal 1 Shakeel A Qureshi 1 Kothandam Sivakumar 2 Matthew Jones 1 San-Fui Yong 1 Saleha Kabir 1 Pramod Sagar 2 Puthiyedath Thejaswi 2 Sebastien Hascoet 3 Clement Batteux 3 Younes Boudjemline 4 Ziyad M Hijazi 4 Jamil A Aboulhosn 5 Daniel S Levi 6 Morris M Salem 6 Edwin Francis 7 Aleksander Kempny 8 Alain Fraisse 8 Carles Bautista-Rodriguez 8 Kevin Walsh 9 Damien Kenny 9 Brian Traynor 9 Salim N Al Maskari 10 James R Bentham 11 László Környei 12 Muthukumaran C Sivaprakasam 13 Ata Firouzi 14 Zahra Khajali 14 Lee Benson 15 Mark Osten 15 Alban-Elouen Baruteau 16 Matthew A Crystal 17 Thomas J Forbes 18 Stanimir Georgiev 19 Horst Sievert 20 Do Nguyen Tin 21 Daniel Springmuller 22 Anand Subramanian 23 Hussein A M Abdullah 24 Radwa Bedair 25 Francisco Chamié 26 Ahmet Celebi 27 Jesus Damsky Barbosa 28 Pieter De Meester 29 Luca Giugno 30 Zakaria Jalal 31 32 33 Clement Karsenty 34 Anastasia Schleiger 35 Gregory Fleming 36 Andre Jakob 37 Tevfik Karagoaz 38 Gur Mainzer 39 Gareth J Morgan 40 Nazmi Narin 41 Shabana Shahanavaz 42 Zachary L Steinberg 43 Osamah Aldoss 44 Elnur Alizade 45 Oliver Aregullin 46 Hélène Bouvaist 47 Thilo Fleck 48 Francois Godart 49 Sophie Malekzadeh-Milani 50 Paulo Motta 51 Angel Sanchez-Recalde 52 Juan Pablo Sandoval 53 Weiyi Tan 54 John Thomson 55 Pablo Tome 56 Evan M Zahn 57

PMID: 39697167 DOI: 10.1161/CIRCULATIONAHA.124.070271

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.

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