The use of a vacuum bell in the treatment of pectus excavatum
2005 Haecker Eur J CT Surg.
Methods: A suction cup is used to create a vacuum at the anterior chest wall. A patient-activated hand pump is used to reduce the pressure up to 15% below atmospheric pressure. Three different sizes of vacuum bell exist which are selected according to the individual patients age. When creating the vacuum, the lift of the sternum is obvious and remains for a different time period. The device should be used for a minimum of 30 min (2 per day), and may be used up to a maximum of several hours daily. Presently, a 12—15-month course of treatment is recommended.
Results: Thirty-four patients (31 males, 3 females), aged 6—52 years (median 17.8 years) used the vacuum bell for 1 to maximum 18 months (median 10.4 months). Follow-up included photography and clinical examination every 3 months. Computed tomographic scans showed that the device lifted the sternum and ribs immediately. In addition, this was confirmed thoracoscopically during the MIRPE procedure. After 3 months, an elevation of more than 1.5 cm was documented in 27 patients (79%). After 12 months, the sternum was lifted to a normal level in five patients (14.7%). Relevant side effects were not noted.
During the first 1—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 haema- toma, which disappeared within a few hours.
In conclusion, the vacuum bell may allow some patients with PE to avoid surgery. Especially patients with symmetric and mild PE may benefit from this procedure. However, the time of follow-up in our series is too short to confirm this with any certainty. Additionally, the intraoperative use of the vacuum bell during the MIRPE may facilitate the introduction of the pectus bar.
2011 Haecker Ped Surg Int Methods: The device should be used for a minimum of 30 min (twice/day), and may be used up to a maximum of several hours daily. Results: One hundred and thirty-three patients (110 males, 23 females) aged from 3 to 61 years (median 16.21 years) used the vacuum bell for 1 to a maximum of 36 months. One hundred and five patients showed a permanent lift of the sternum for more than 1 cm after 3 months of daily application. Thirteen patients stopped the application and underwent MIRPE. Relevant side effects were not noted. 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. Some patients followed the user instructions and applied the device twice daily for 30 min each.
Adolescent boys applied the device every night for 7–8 h. In fact, the duration and frequency of daily application depends on the patients’ individual decision and motivation.
2016 Haecker Ann CT Surg In 1992, the engineer E. Klobe, who suffered from PE, developed a new device to conservatively treat PE (16). Since 2003, approx. 450 patients between 2 to 61 years of age started the VB therapy. Age and gender specific differences, depth of PE, symmetry or asymmetry, and concomitant malformations such as scoliosis and/or kyphosis influence the clinical course and success of VB therapy. According to our experience, we see three different groups of patients. Immediate elevation of the sternum was confirmed thoracoscopically during the Nuss procedure in every patient.
The VBs by E. Klobe are CE certified and patent registered. In the United States, the device was approved by the food and drug administration (FDA) in May 2012. According to the instructions and our experience, the VB should be used at home for a minimum of 30 minutes, twice a day during 4–6 weeks. Afterwards, the application may be used up to a maximum of several hours daily (16,18-22). The immediate elevation of sternum and ribs during application of the VB was demonstrated through a study by Schier and Bahr (17). We confirmed this effect by thoracoscopy during the MIRPE procedure (25). We use the VB routinely in every patient during MIRPE. After exclusion of cardiac anomalies and other contraindications, patients may start with the daily application. All users are recommended to use the device twice daily for 30 minutes each for the first 4–6 weeks. Later on, the length of time of daily application of the VB will vary widely between patients. Some of the adult patients use the VB up to 8 hours daily during office hours, whereas adolescent boys may apply the device every night for 7–8 hours. In our experience, the duration and frequency of daily application depends on each patient’s individual choice and motivation. Patients undergo follow-up visits at 3 to 6 month
2016 Obermeyer J Vir Surg In this manuscript, Haecker and Sesia outline how vacuum bell therapy (VBT) provides patients with a non-operative approach that is attractive due to the potential serious, albeit rare, complications associated with minimally invasive repair of pectus excavatum (MIRPE). Compared to surgery, VBT has the distinct advantage of having few side-effects if used as directed. In addition, the side-effects are typically minor and self-limited including: bruising, petechial bleeding, subcutaneous hematoma, skin breakdown, dorsalgia, and transient paresthesia. The effects of lifting the sternum and anterior chest wall, at least temporarily, have been confirmed both radiographically by computer tomography (1) and thoracoscopically during MIRPE (2,3). However, the sustained lift of the chest wall, and subsequent “correction” of pectus excavatum, by the effects of repetitive use of the vacuum bell is variable with this therapy. Complete “correction” of PE via VBT has been reported in the literature to range from 13.5–37.5%. Schier et al. published short-term results of VBT on 60 patients in 2005 and about 20% were “corrected” after 5 months of treatment (1). In 2011, Dr. Haecker published the first longer-term report demonstrating similar results with close to 13.5% being “corrected” after 18 months of VBT (4). More recently in 2015 Lopez et al. reported a 31.5% rate of “correction”, increasing to 37.5% when looking at a pediatric subgroup (5). Dr. Haecker and Dr. Sesia have also set out to help clarify which subgroups of patients may or may not be optimal candidates for VBT. As they have noted, VBT has also found other niches in the surgeons’ armamentarium for treating patients with pectus excavatum including: mild defects, intraoperative sternal elevation, under-correction, mild recurrences, and patients adverse to surgical correction.
2018 Hacker Eur J Pediatr Surg In our largest series including more than 500 patients, $80% of PE patients applied for conservative treatment using the VB, whereas 20% underwent surgical repair. In summary, VB therapy is established as an additional useful tool in specific treatment of patients suffering from PE. VB therapy represents no contra- diction, but a complement in the specific treatment of PE patients, applicable to a significant majority of PE patients. Furthermore, VB therapy may allow some patients with PE to avoid surgery.
2018 Obermeyer J Pediatr Surg Schier et al. were the first to describe the use of the vacuum bell as an adjunct during the Nuss procedure to elevate the sternum when creating the substernal tunnel [10] The use of the vacuum bell as an alternative to operative management has been extensively reported on by Haecker, et al. in Switzerland [7–9]. They noted that symmetric and mild pectus excavatum deformities are most likely to benefit. While an optimal age is not defined, they clearly noted that patients beyond adolescence with depths N 3 cm often require a longer duration of therapy. They also aptly noted that the growth spurt during puberty likely adversely influences vacuum bell outcomes owing to the typical progression of pectus depth and severity [9]. Lopez et al. also recently reported that patients b18 years old had better outcomes [12]. However, it remains unclear from these studies specifically which patients are most likely to achieve an excellent correction of pectus excavatum with vacuum bell therapy. Our study aims to identify variables associated with an excellent correction and thus help optimize patient selection.
Methods: An IRB-approved (15-01-WC-0024), single institution, retrospective study evaluating outcomes of vacuum bell therapy to treat pectus excavatum nonoperatively over 4 years (11/2012–11/2016) was performed. Indications for vacuum bell therapy included patients who are not surgical candidates, too young for surgery, don’t want surgery, recurrence after surgery, and rigid chests in preparation for surgery. Contraindications to vacuum bell therapy included: age less than 6 years old, skeletal disorders (e.g., osteogenesis imperfecta, osteoporosis, Glisson’s disease), vasculopathies (e.g., Marfan’s disease, aortic aneurysms or dilated aortic root), coagulopathies (e.g., hemophilia, thrombocytopenia, etc) and cardiac disorders.
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First, we rely on accurate self-reported use of the vacuum bell with regard to daily use and pressure. Second, the pressure is not identical for every application owing to variable positioning of the vacuum bell on the chest wall and patient movement. Other factors that vary suction pressure over time include patient growth, skeletal maturation, and increased flexibility of the silicon bell and hand pump. Finally, there are several patient characteristics which are subjectively defined including chest wall shape, symmetry, and flexibility. While the first two subjective variables have an accepted description in the literature, flexibility of the chest wall has been less clearly defined until now with the Nuss maneuver. Conclusion : Nonoperative management of pectus excavatum with vacuum bell therapy results in an excellent correction in a small percentage of patients with minimal side effects. While not requisite, variables predictive of an excellent outcome included age ≤ 11 years, chest wall depth ≤ 1.5 cm, chest wall flexibility, and vacuum bell use over 12 consecutive months. More data and long term outcomes are needed to more clearly define the ideal patients for vacuum bell therapy.
2018 Togoro J Pediatr Surg The Vacuum Bell (Eckart Klobe, Mannheim, Germany) is a suction cup that creates a vacuum on the anterior chest wall and is activated by a patient-controlled hand pump. Four different sizes and a model fitted for women are available, allowing selection according to an individual patient’s age and size. The vacuum device has at least four proposed applications. First, it may allow some patients with PE to avoid surgery [7]. Second, the suction device may be useful in preparation for surgery. Third, the device may be helpful if a surgical implantable bar has to be removed earlier than scheduled. Finally, it has been used intraoperatively as the vacuum device is externally applied for a short duration to lift the sternum away from the heart during MIRPE to provide more working space for safely guiding the bar(s) across the mediastinum under thoracoscopic visualization.
Between February and May 2013, 30 patients who had PE were evaluated to determine whether they could be included in a funded trial de- signed to evaluate the degree to which the Vacuum Bell lifts the sternum. The inclusion criteria for the study were patients with PE ages 8 to 35 years old. Exclusion criteria were complex mixed carinatum/excavatum cases, comorbidities including skeletal diseases, coagulation dysfunction, cutaneous diseases in the thoracic wall, angiopathies, pregnancy, and obesity with Body Mass Index (BMI) > 30. Our results have confirmed that, with just 2–3 min of negative pressure applied to the anterior thoracic chest wall, the sternum was pulled forward in all our study patients independent of age, gender, chest symmetry, and pectus subtype. By examining changes during suction, we found that individuals with lower BMI and with a smaller chest depth tend to have more sternal lift with the vacuum. By examining changes in HI before and after vacuum use, it was found that a smaller initial excavation depth or higher initial HI is associated with better short-term Vacuum Bell efficacy. In other words, if short-term Vacuum Bell efficacy is defined by an improvement in the distance between the sternum and vertebral column, then greater efficacy is associated with lower BMI. If short-term Vacuum Bell efficacy is defined by decrease in HI, then improved efficacy is associated with a greater distance between the sternum and vertebral column.
2019 Haecker Interactive CVT Surg This was a literature review of using the bell during MIRPE
2019 Patel Interactive CVT Surg Summary of the literature to date on nonoperative management of PE with the vacuum bell
2005 Schier J Pediatr Surg Schier et al. [7] reported on the treatment of PE with VBT in 60 patients, aged 6.1–34.9years (median 14.8years). After 1month of use, elevation of 1cm was noted in 85% of patients; after 5months, the sternum was lifted to a normal level in 20% of patients.
2019 St-Louis J Pediatr Surg The study was conducted at the Chest Wall Anomalies Center of the Shriners Hospital for Children Canada and the pediatric surgical clinic of the Children’s Hospital of Eastern Ontario. Prospectively maintained databases were reviewed to identify all patients ≤21 years-old treated with the vacuum bell for PE from February 2013 to December 2017. Prior to receiving therapy, all patients were assessed for demographics (age, gender, height, weight, family history of chest wall anomalies, and symmetry of PE), comorbidities, symptoms (chest pain, shortness of breath on exertion, palpitations, and other), and PE specific data (Haller Index, depth and cardiopulmonary studies if indicated). At the Shriners site, anterior– posterior and lateral chest radiographs using a low-dose radiation imaging system were used to calculate the Haller Index. Regular chest radiographs were used at the Ottawa site. Additionally, the average depth between inspiration and expiration was measured. Five sizes of the vacuum bell currently exist, made to suit males and females from childhood to adulthood. During the initial consultation, the vacuum bell was shown as a potential treatment for preteens who were motivated to improve their chest wall appearance while considered still young for surgical correction, or as an alternative to operative repair in teenagers who preferred to avoid surgery. During the first clinic encounter after receiving the bell, patients were shown how to use it according to the manufacturer’s instructions and supervised on their first attempt. The bell was centered as much as possible over the deepest point of the chest depression, avoiding the areolae and nipples. The use of the bell would be gradually increased, beginning from 15 min a day up to several hours as tolerated. The parents of children under 10 years old were advised to supervise their child during the application of the bell [3]. Follow-up protocol involved visits every 3 months for the first year, every 6 months for the second, and then yearly thereafter. During these visits, patients were asked about their usage frequency and duration (days per week and hours per day), any complications they may have encountered, device malfunctions, and their general satisfaction and motivation with the therapy. Depth was measured at each visit to assess progression, while photos and Haller Indices were recorded on a yearly basis.
Having followed 434 patients over a 13-year period, Haeker et al. recommended that the vacuum bell be used initially for 30 min, 2 times a day for 4–6 weeks, after which it should be increased to several hours per day [3]. Obermeyer et al. analyzed data on 115 patients for a median follow- up of 12 months. They achieved 20% excellent correction and 17% good correction, and identified factors predictive of excellent correction, including initial age less than 11 years old, initial chest wall depth less than 1.5 cm, vacuum use over 12 consecutive months, and chest wall flexibility (flattening of the deformity during Valsalva maneuver). We found that both greater time of vacuum bell use per day (N2 h) and usage every day of the week, which may serve as indicators of patient motivation, were significantly associated with improvement in deformity depth. Improvements in Haller Index were significantly less in those aged between 11 and 15 years and those older than 16 years, when compared to patients under 10 years-old.
2020 Gau Ped Surg Int Eighty-two patients (12/2017–12/2019) met the criteria at the clinic, and 24 patients (29.3%) achieved excellent correction (3D-DE ≤ 3 mm). Eighty-two patients required to be followed up every three months were included in this retrospective study and distributed into four stages (stage 1: treated for 3 months, stage 2: treated for 6 months, stage 3: treated for 9 months, and stage 4: treated for 12 months). In addition, the deformity in the chest wall was scanned by a 3D scanner at the clinic, and the 3D depth (3D-DE) and 3D Haller index (3D-HI) of PE were calculated. A statistically significant difference was observed between stages 2 and 1 (3D-DE p < 0.01, 3D-HI p < 0.01), stages 3 and 2 (3D-DE p < 0.01, 3D-HI p < 0.01) and stages 4 and 3. Patients aged < 10 years, with symmetrical PE and treated for over 12 months may achieve a better outcome.
The indications for intervention with a VB were failure to meet the operative criteria, moderate to severe pectus excavatum, too young for surgery (age ≥ 3 years old), various degrees of asymmetric pectus excavatum, aversion to surgery, recurrence after surgery, and acquired pectus excavatum (thoracotomy surgery). The contraindications for intervention with a VB were coagulopathies, skeletal disorders, vasculopathies, skin dis- orders and cardiac insufficiency. The maintenance strategy was that the patients who achieved an excellent outcome should continue to use the device for 2–3 years, especially adolescent patients, and we strongly recommended that they should use the device until the end of puberty. The standard protocol for treating patients with a VB is as follows: (1) Adaptive period: within 2 weeks, vacuum bell were used for 10–15 min at a time to increase the tolerance of the chest wall. The use time was gradually increased to 15–20 min/session at week 3 and gradually increased to 20–30 min/session at week 4. During the first month, the vacuum bell was applied for ≥ 120 min daily.
(2) Maintenance period: the use time of the vacuum bell was 30–60 min for 4 times a day, and occasionally, the management strategy varied owing to caregiver willingness, patient compliance and physician experience. All patients were recommended to participate in sports (e.g., swimming with breaststroke or chest-expanding exercises). Patients should be followed up every 3 months according to the schedule. A total of 109 patients were enrolled from December 2017 to December 2019. Despite scheduling the follow-up evaluations, 16 patients quit the study. The most common side effects were moderate subcutaneous hematoma (68%), petechial bleeding (15%), thoracalgia (23%) and chest swelling (18%). One patient suffered from mammary development. The common side effects disappeared when the pressure was reduced or the treatment time was shortened, and no analgesic medication was used in our study.
Many studies [18, 26, 27] have reported that thoracic flexibility is a significant indicator of success. In our study, the VB was also effective for correcting asymmetric PE, and a significant difference between symmetric and asymmetric patients was proven in statistical analysis. This is an important contrast to the results of Robert et al.
History: The earliest report about PE, that has been cited, is the case of the deformity identified by Bauhinus from 1594. However, a recent published study analyzed more than 600 artifacts from Ancient Egypt, showing that CWDs were already displayed in reliefs from Ancient Egypt dating back to ca. 2400 BC. The number of articles reporting on different aspects of PE treatment raised from $300 (1980–1989) to more than 600 (2000–2009). The technique of minimally invasive repair of pectus excavatum (MIRPE) was first described by Nuss et al8 to avoid several operative features of the modified Ravitch repair procedure.
Sizes: The diameter is 16 cm for the small model, 19 cm for the medium-size model, and 26 cm for the large model. The medium-size model is available in a supplemental version with a reinforced silicon wall (e.g., for adult patients with a small deep pectus). The appropriate type and model of the device were determined according to the individual patients’ chest wall size.
Links:http://www.trichterbrust.de/
Uses: Intraoperatively during the Nuss procedure and as a stand-alone therapy
Bracing history: The natural history of PC is of a mild defect seen in infancy, which is stable during childhood, but then worsens dramatically with the growth spurt during puberty. Most patients with PC show mild or no relevant clinical symptoms. In contrast to PE, PC does not typically result in any significant physical or cardiopulmonary symptoms. The most frequently reported symptoms are tenderness, bone pain, or mild exercise intolerance. However, the majority of PC patients have a disturbed body image, the patients’ introspection may be impaired. As consequence, many PC patients suffer from a reduced quality of life. In contrast to the standardized diagnostic workup for PE patients, there are no objective parameters to indicate any type of treatment for PC patients. Dependent on the patients’ age and the severity of the deformity, current treatment options include observation, bracing, or surgical repair. Based on the fact that the anterior chest wall is still compliant during puberty and that it permits remodeling by external compression, many authors have suggested a nonsurgical approach for PC patients. Haje and Bowen reported on successful brace therapy for the first time in 1992.