Surgical management of digital ulcers in systemic sclerosis: A systematic literature review.

BACKGROUND

There is a strong rationale to develop locally-acting surgical treatments for digital ulcers (DUs) in patients with systemic sclerosis (SSc). Our aim was to examine the safety and efficacy of local surgical management for SSc-DU.

METHODS

A systematic literature review was carried out until to August 2022 using 7 different databases. Original research studies concerning adult patients with SSc-DUs, and local surgical treatments were analysed using the PICO framework. We included randomized controlled trials, prospective/retrospective studies, and case series (minimum of 3 patients) References were independently screened by two reviewers including assessment of the risk of bias using validated tools.

RESULTS

Out of 899, 13eligible articles were included. Autologous fat (adipose tissue AT) grafting was the surgical modality most identified (7 studies, 1 randomized controlled double blinded trial and 6 prospective open-label single arm studies). The healing rate (HR) with autologous fat grafting (4 studies) was 66-100 %. Three studies reported autologous adipose-derived stromal vascular fraction grafting: HR of 32-60 %. Bone marrow derived cell transplantation in a single study showed 100 % healing rate over 4-24 weeks. Surgical sympathectomy was examined in 3 studies, prospective without comparator with a median healing rate of 81 %. Two surgical studies (of direct microsurgical revascularisation and microsurgical arteriolysis) showed 100 % healing of ulcers, with no complications.

CONCLUSION

Several surgical approaches for SSc-DUs have demonstrated some degree of safety and effectiveness for DU healing. However, there are significant methodological issues. Future studies are warranted to rigorously investigate surgical interventions for SSc-DUs.

Informations de copyright

Copyright © 2023. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Declaration of Competing Interest YAS: No conflict of interest to declare CC: No conflict of interest to declare MH: Speaking fees from Actelion Pharmaceuticals, Eli Lilly, and Pfizer, outside of the submitted work. Member of a Data and Safety Monitoring Board for Certa Therapeutics. JWS: No conflict of interest to declare DG: No conflict of interest to declare PM: Speaking fees from Actelion Pharmaceuticals and Boehringer Ingelheim. MB: No conflict of interest to declare LC: Has served as an Advisor and Steering Committee member for Eicos Sciences. Has received consulting fees from Mitsubishi Tanabe, Genentech, Kyverna, and Jasper. LR: No conflict of interest to declare NM: No conflict of interest to declare YA: Consulting fees from Boehringer Ingelheim and Sanofi, payment, or honoraria from Boehringer Ingelheim and participation in Data Safety or Advisory Board for Boehringer Ingelheim, Menarini, Chemomab, Curzion, Medseni, Sanofi. CPD: Received grants from GlaxoSmithKline, Inventiva, CSL Behring, Servier, Arxx Therapeutics. Consulting fees from GlaxoSmithKline, Janssen, Bayer, Sanofi, Inventiva, Boehringer Ingelheim, Roche, CSL Behring, Corbus, Acceleron. OD: Consultancy relationship with and/or has received research funding from and/or has served as a speaker for the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three calendar years: Abbvie, Acceleron, Alcimed, Amgen, AnaMar, Arxx, AstraZeneca, Baecon, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL, Behring, Galapagos, Glenmark, Horizon, Inventiva, Kymera, Lupin, Medscape, Miltenyi Biotec, Mitsubishi Tanabe, MSD, Novartis, Prometheus, Roivant, Sanofi and Topadur. Patent issued “mir-29 for the treatment of systemic sclerosis” (US8247389, EP2331143). TF: Held a paid leadership role with the Scleroderma Clinical Trials Consortium. DEF: Grants or contracts from Amgen, Corbus, CSL Behring, Galapagos, Gilead, GSK, Horizon, Kadmon, Novartis, Pfizer, Roche / Genentech, Talaris. Consulting fees from Amgen, Corbus, Galapagos, Horizon, Kadmon, Pfizer, Talaris. Payment or honoraria from CME. DK: Consulting fees from Actelion Pharmaceuticals, Acceleron, Amgen, Bayer, Boehringer Ingelheim, Chemomab, CSL Behring, Genentech / Roche, Horizon, Paracrine Cell Therapy, Mitsubishi Tanabe, Prometheus. Stock or stock options in Eicos Sciences Inc. TK: World Scleroderma Foundation Board Member, Edith Busch Foundation Advisory Board Member, German Scleroderma Foundation Board Member. MK: Speakers fees from Abbvie, Asahi-Kasei, Astellas, Boehringer-Ingelheim, Chugai, Eisai, Nippon Shinyaku, Ono Pharmaceuticals, Tanabe-Mitsubishi; Consultant fees from AstraZeneca, Boehringer-Ingelheim, Chugai, Corbus, GSK, Horizon, Mochida, Kissei; Grant/research support from Boehringer-Ingelheim, MBL, Ono Pharmaceuticals. MMC: Grants from Actelion Pharmaceuticals, consulting fees from Actelion Pharmaceuticals, Biogen, Bayer, Boehringer Ingelheim, CSL Behring, Eli Lilly. JP: No conflict of interest to declare AA: No conflict of interest to declare