Vacuum Bell Medical Study
This post contains information on a medical study conducted to assess the viability of vacuum bell devices for the treatment of Pectus Excvatum. As part of the study thirty-four patients (31 males, 3 females), aged from 6 to 52 years (median 17.8 years, Fig. 3 ) were treated with the vacuum bell for 1 to a maximum of 18 months (median 10.4 months). For further evaluation, patients were divided into two groups. Group 1 included 23 paediatric patients aged =18 years. Group 2 comprised 11 adult patients aged from 19 to 52 years (Fig. 3). Standardized evaluations before starting the procedure included 3D computerized tomography (CT) scans, pulmonary function tests, cardiac evaluations with electrocardiogram, echocardiography and photo documentation. In addition, the depth of PE was measured by a medical practitioner. Patients subsequently underwent follow-up examinations at 3?6 monthly intervals including photography and clinical examination.
The first application of the vacuum bell occurred under supervision of the attending doctor. The length of time of daily application of the vacuum bell varied widely between patients. Patients were told to follow the user instructions applying the device twice daily for 30 min each. In fact, the duration and frequency of daily application depends on the patients individual decision and motivation. One patient, a 52-year-old businessman, used the vacuum bell for 4?6 hours on a daily basis during office hours. Two adolescent boys applied the device every night for 7?8 h. A 21-year-old male patient, who underwent Pectus Excavatum repair by the Ravitch procedure 6 years previously, was dissatisfied with the postoperative result and recently started treatment with the vacuum bell. In addition to the daily application of the device, all patients were recommended to carry on undertaking physiotherapy as well as sports, e.g. swimming. Physical fitness, especially chest fitness with well developed pectoralis major muscle did not hinder the correction in anyone of our patients.
During the first 5 applications, all patients experienced moderate pain in the sternum and reported a feeling of uncomfortable pressure within the chest. Adolescent and older patients developed moderate subcutaneous haematoma, which disappeared within a few hours. Two patients reported recurrent transient paresthesia of the upper extremities during the application. But this phenomena disappeared when lower atmospheric pressure was used during application. One 45-year-old patient suffering from recurrent dorsalgia, reducing the application time, prevented the occurrence of discomfort. Analgesic medication was not necessary in any patient. In patients younger than 10 years of age, the application was supervised by the parents. In these patients, there were no relevant side effects reported.
Before starting the treatment, the depth of PE ranged from 2.5 cm to 5 cm. In all patients, the sternum and the ribs were lifted immediately after application of the device. The elevation of the sternum was more obvious in the paediatric group. However, after removal of the vacuum bell the sternum subsided faster in paediatric patients than in adults, where the elevation lasted for 30?60 min. In accordance with this observation, the elevation of the sternum was more successful within the first 6?9 months of application in group 1. In contrary, adult patients demonstrated a slower but continuous decrease of Pectus Excavatum. In 27 patients (79%), after 3 months of treatment, a permanent elevation of more than 1.5 cm was documented. Figs. 4 and 5 demonstrate the result after 6 months and after 10 months treatment, respectively. In five patients (14.7%), the sternum was permanently lifted to a normal level after 12 months. In three patients with asymmetric Pectus Excavatum, the depth of the abnormality decreased after 9 months, but the asymmetry remained visible. A 19-year-old patient with an isolated, asymmetric deformity of the upper chest wall stopped the application after 6 months due to an unsatisfactory result. At follow-up, all paediatric and adult patients except the last one were satisfied and expressed their motivation to continue the application.
In summary, the study revealed that the vacuum bell was able to produce significant improvements in the shape and appearence of the chest wall and went great lengths to removing Pectus Excavatum. The extent of these improvements proved to be largely dependent on the length of time and frequency with which the device was applied. Those who used the vacuum bell more regularly and for longer periods of time experienced more significant improvements. For more information on the vacuum bell and how to start your own treatment plan, please visit the vacuum bell page.