Original Title: Campana de vacío como tratamiento no invasivo del pectus excavatum: seguridad y eficacia

Authors' objectives: The primary objective was to determine the clinical outcomes of the vacuum bell in patients aged 18 years or younger with a diagnosis of PE compared with MIRPE, or in patients with severe PE who cannot undergo surgery cause their young age.

Authors' results and conclusions: A total of 983 studies were retrieved after eliminating duplicates. Of these, 35 studies were selected for full-text reading, and 4 publications were eventually included to respond to the objective of this report: a CPG published in 2024, a RCT in 2020, and two observational studies (a prospective study from 2016 and a quasi-experimental before-and-after study from 2019). None of the studies located in the literature search evaluated the vacuum bell versus standard-of-care MIRPE, so no information on compared effectiveness can be provided. In its question on the use of this device, the CPG included only retrospective case series to evaluate its effectiveness in correcting PE; therefore, its recommendation for use in young patients with mild deformities and a flexible thorax is based on a very low level of evidence. The quasi-experimental studies in patients too young for a surgical indication, or who did not want to undergo surgery (n = 31 patients), showed mild improvements in the depth of the deformity, but without any significant impact on the Haller index, and the results vary depending on the frequency of use and treatment duration. Two studies reported safety outcomes, although one of them referenced such data only globally. The other study (n = 31) found that 12.9% of patients discontinued the treatment owing to cutaneous complications, such as changes in pigmentation, irritation and acne. The most common complication was the development of petechiae in 29% of patients, followed by skin darkening (9.7%) and seromas or back pain (6.5%). All these complications resolved shortly after removing the bell, reducing the vacuum, or taking short breaks in the treatment. Quality of life was assessed by an RCT (n = 26 patients) that did not find improvements in psychological aspects in either patients or parents. In terms of quality of physical life, parents reported better scores in both groups (bell alone and bell with physiotherapy), but patients only reported significant improvements when the bell was combined with physiotherapy. With regard to patient satisfaction with the result, this RCT also shows higher levels of satisfaction when the treatment was combined with physiotherapy. In thesecases, the result was ‘better’ or ‘much better’ (p = 0.046). A case series (n = 56) reported a high level of satisfaction of both patients and parents, although it used a subjective scale without specifying any clear criteria. In general, the studies lack adequate control and do not provide solid evidence to appraise the clinical effectiveness of the vacuum bell in terms of satisfaction and acceptability.

Authors' methods: A systematic review was carried out with a literature search updated as of October 2024 and with a 10-year time limit. This search was conducted in specialised systematic review databases (Cochrane Library, International HTA Database, Epistemonikos, etc.) and general databases (Medline, Embase, etc.). Both free terms and PE-related descriptors were used for the search. The program EndNote 20.3 was used to remove duplicates and manage bibliographical references. The study selection was performed using the software Covidence©. The criteria established for the selection of studies were systematic reviews, randomised controlled clinical trials (RCTs), observational studies with a comparison group, and consecutive case series with n > 10 evaluating the effect of the vacuum bell onpatients under 18 years of age with PE versus MIRPE. Two independent reviewers carried out the data selection and extraction, and any doubts were solved by consensus. The quality of the studies was assessed using validated tools, such as the Appraisal of Guidelines for Research and Evaluation (AGREE II) for clinical practice guidelines, RoB 2 for RCTs, and the Institute of Health Economics (IHE) checklist for case series. A narrative synthesis of the results was carried out.

Project Status: Completed

Year Published: 2025

URL for published report: https://runa.sergas.gal/xmlui/bitstream/handle/20.500.11940/20182/avaliat2331CampanaVacioPectus_DEF_NIPOTRAMITE.pdf?sequence=3&isAllowed=y

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Spain

Organisation Name: Scientific Advice Unit, avalia-t; The Galician Health Knowledge Agency (ACIS)

Contact Address: Conselleria de Sanidade, Xunta de Galicia, San Lazaro s/n 15781 Santiago de Compostela, Spain. Tel: 34 981 541831; Fax: 34 981 542854;

Contact Name: avalia_t.acis@sergas.es

Contact Email: avalia_t.acis@sergas.es

Copyright: Scientific Advice Unit, Avalia-t; The Galician Health Knowledge Agency (ACIS)