Nowadays information on new therapeutic modalities circulates not only among surgeons and paediatricians but also rapidly among patients. In particular, patients who refused operative treatment by previously available procedures, now appear at the outpatient clinic and request to be considered for the new method. The vacuum method was used as early as 1910 by Lange [8] for elevating the sternum, but has not been previously applicated in a large number of patients, and long-term results are not reported. The vacuum bell used in our patients group was developed by an engineer, who himself suffered from PE (Klobe, http://www.trichterbrust.de). Long-term evidence of persistent effects of the treatment modality are not yet available, since the method has only been used for a maximum of 2 years. However, initial results proved dramatic, and the acceptance and compliance of patients seem to be good. In many cases of PE, the degree of pectus deformity does not immediately warrant surgery, yet patients may benefit from some type of nonsurgical treatment. Other patients are disinclined to undergo surgery because of possible complications after surgery, because of the pain associated with postoperative recovery and the risk of imperfect results. Thus, the introduction of the vacuum bell for conservative treatment of PE has generated much interest among patients with PE, despite of the lack so far of long-term results of the method.
The success of a therapeutic procedure not only requires a good technique, but also depends on a appropriate indication. In our study, patients, who presented with symmetric and mild PE, seemed to show a more successful outcome than those with asymmetric and deep PE. The application of the vacuum bell was well tolerated by both paediatric and adult patients. All patients except one were satisfied with the use of the vacuum bell, although objectively assessed improvement of PE varied between the individuals. All our patients were recommended to carry on undertaking sports and physiotherapy, so that the accompanying improvement of body control was an important factor in outcome. The participation of patients themselves in the ‘active’ treatment of PE clearly increases motivation to maintain therapy. The manufacturers instructions and our treatment protocol recommended application of the device twice daily for 30 min each. However, the definitive duration and length of use was determined by the individual patient and the parents, respectively. As demonstrated in the CT-scan (Bahr, http://www.trichterbrust.de), the force of the vacuum bell is strong enough to deform the chest within minutes. Therefore, especially in children younger than 10 years of age the application of the vacuum bell has to be performed carefully and should be supervised by an adult.
When creating the vacuum, the elevation of the sternum is obvious and persists for a distinct period of time. Therefore, the vacuum cup may also be useful in reducing the risk of injury to the heart during the MIRPE procedure, where the riskiest step of the procedure is the advancement of the introducer between the heart and sternum. Since the manufacturer of the device has not yet a license to sterilise the vacuum bell, this additional use has to be considered as a clinical trial. In accordance with our hospital hygienist, we applied the vacuum bell during the MIRPE procedure in a few patients with good experience. In addition, the vacuum bell may be useful in a way of ‘pretreatment’ to surgery. Since none of the 34 patients asked for the MIRPE procedure, we could not confirm this hypothesis at the moment.
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. This must be evaluated by further studies. In any case, the method seems to be a valuable adjunct therapy in the treatment of PE.
Sunday 18 July 2010
Results of Tests
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 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 PE. 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 PE, the depth of PE has decreased after 9 months, but the asymmetry is still 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.
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 PE. 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 PE, the depth of PE has decreased after 9 months, but the asymmetry is still 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.
Patients and Methods
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). Standardised evaluation before starting the procedure included 3D computerised tomography (CT) scan, pulmonary function tests, cardiac evaluation with electrocardiogram and echocardiography and photo documentation. In addition, the depth of PE was measured. Patients underwent follow-up 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 4–6 h daily during office hours. Two adolescent boys applied the device every night for 7–8 h. A 21-year-old male patient, who underwent PE repair by the Ravitch procedure 6 years ago, 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.
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 4–6 h daily during office hours. Two adolescent boys applied the device every night for 7–8 h. A 21-year-old male patient, who underwent PE repair by the Ravitch procedure 6 years ago, 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.
The Vacuum Bell
A suction cup is used to create a vacuum at the chest wall. A vacuum up to 15% below atmospheric pressure is created by the patient using a hand pump (Fig. 1 ). Three different sizes (16 cm, 19 cm and 26 cm in diameter) exist allowing selection according to the individual patients age. The development of a specific fitted model suitable for women is in progress. Pilot studies performed by Bahr and Schier in Jena, Germany (http://www.trichterbrust.de) showed that the device lifted the sternum and ribs immediately (Fig. 2 ). In addition, this was confirmed thoracoscopically during the MIRPE procedure. According to the user instructions and our experience, the vacuum bell should be used for a minimum of 30 min, twice per day, and may be used up to a maximum of several hours daily.
Complications and relevant side effects include subcutaneous haematoma, petechial bleeding, dorsalgia and transient paresthesia of the upper extremities during the application as well as rib fractures in rare cases. Contraindications of the method comprise skeletal disorders such as osteogenesis imperfecta and Glisson's disease, vasculopathies (e.g. Marfan's syndrome, abdominal aneurysm), coagulopathies and cardiac disorders. To exclude these disorders, a standardised evaluation protocol was routinely performed before beginning the therapy.
Complications and relevant side effects include subcutaneous haematoma, petechial bleeding, dorsalgia and transient paresthesia of the upper extremities during the application as well as rib fractures in rare cases. Contraindications of the method comprise skeletal disorders such as osteogenesis imperfecta and Glisson's disease, vasculopathies (e.g. Marfan's syndrome, abdominal aneurysm), coagulopathies and cardiac disorders. To exclude these disorders, a standardised evaluation protocol was routinely performed before beginning the therapy.
Pectus Excavatum
Pectus excavatum (PE) is the most common chest wall malformation and one of the most frequent major congenital anomalies. The surgical repair of PE in childhood is a well-established procedure. Previously used operative techniques to correct PE were largely based on the Ravitch technique. Today, the minimally invasive repair (MIRPE) by Nuss is well established. Conservative treatment with the vacuum bell to elevate the funnel in patients with PE represents a potential alternative. 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. In addition, the device was used intraoperatively during the MIRPE procedure to enlarge the retrosternal space to ensure safer passage of the introducer in a few patients. 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. Conclusions: The vacuum bell has proved to be an alternative therapeutic option in selected patients with PE. The initial results proved to be dramatic, but long-term results are so far lacking, and further evaluation and follow-up studies are necessary. In addition, the method may assist the surgeon during the MIRPE procedure.
For more information on the Pectus Excavatum deformity, please visit www.whatispectusexcavatum.com.
For more information on the Pectus Excavatum deformity, please visit www.whatispectusexcavatum.com.
Method of Usage
The rubber bell is placed onto the chest wall so that a seal is created, and a hand pump connected to the bell by an air tube is used to reduce pressure inside the bell to up to 15% below atmospheric pressure. The drop in pressure results in the sternum being lifted upwards and a temporary resolution of the deformity.
Definition of Vacuum Bell Therapy
The vacuum bell is a medical device used in the treatment of pectus excavatum, one of the most common chest wall defects.[1] The bell is mainly used to treat the cosmetic problems associated with the condition, as symptomatic cases of pectus excavatum are usually more severe, and may require surgery. It was invented by a German engineer named Eckart Klobe, and is sold in the European Union by Eckart Klobe himself and in the U.S. by Costa.
A 2006 study of 34 patients (31 male and 3 female), aged between 6–52 years, who used the bell for 1–18 months showed immediate improvements. The patients were followed up with clinical examination, photography and CT scans. After 3 months, 27 of the patients displayed an elevation of the sternum of more than 1.5 cm, and after 12 months the sternum was lifted to a normal level within 5 of the patients. Studies showing long term improvements are currently lacking.
A 2006 study of 34 patients (31 male and 3 female), aged between 6–52 years, who used the bell for 1–18 months showed immediate improvements. The patients were followed up with clinical examination, photography and CT scans. After 3 months, 27 of the patients displayed an elevation of the sternum of more than 1.5 cm, and after 12 months the sternum was lifted to a normal level within 5 of the patients. Studies showing long term improvements are currently lacking.
About Vacuum Bell Therapy
This is an experimental approach which offers a non-surgical solution to pectus excavatum. It works by pulling the depressed chest forwards and, by holding this position and with treatment over a few years, to re-shape the chest. A suction cap is placed over the depressed area and a vacuum is created between it and the underlying chest wall. A patient-activated hand pump is used to reduce the pressure up to 15% below atmospheric pressure. It is suggested that the device be used for a minimum of 30 minutes, at least twice a day. It may be used for a maximum of several hours each day. Excessive negative pressure or more prolonged application can cause bruising and swelling with damage to the chest wall.
Presently, the daily treatments are recommended for 12 – 15 months. Some successes have been reported in young children. However, at present its place in the management of older people and the durability of any improvement reported is not known
Presently, the daily treatments are recommended for 12 – 15 months. Some successes have been reported in young children. However, at present its place in the management of older people and the durability of any improvement reported is not known
The Differences Between Costa and Klobe Vacuum Bells
The Costa vacuum bell is black, whilst the Klobe vacuum bell is white, and both the vacuum bells have a slightly different positions for the suction pipe, but other than that they are identical in design and materials used.
The two versions of Vacuum bell do, however, differ greatly in price; the Costa vacuum bell is priced at 450 USD, whilst the Klobe vacuum bell is more expensive; priced at 600 USD. Moreover, whilst the Costa Vacuum bell is available in the US and Europe, the Klobe vacuum Bell is only attainable in Europe.
However, whilst it is only possible to get the Costa vacuum bell in one size; 10 inch vacuum bell intended for male adults 5'7 or taller.
The Klobe vacuum bell comes in 5 different sizes:
The Large Vacuum Bell, diameter about 10", for male persons taller than approx. 5´ 7" (1.70 meters)
The Small Vacuum Bell, diameter about 7.5", for person taller than approx. 4´ 7" (1.40 meters)
The Small Vacuum Bell Type Bodybuilder for bodybuilders and special applications
The Mini Vacuum Bell, diameter about 6.3", for children taller than approx. 3´ 5" (1.04 meters) The Vacuum Bell for women
Please follow these links for more information on the Vaccum Bell and the treatment of Pectus Excavatum.
The two versions of Vacuum bell do, however, differ greatly in price; the Costa vacuum bell is priced at 450 USD, whilst the Klobe vacuum bell is more expensive; priced at 600 USD. Moreover, whilst the Costa Vacuum bell is available in the US and Europe, the Klobe vacuum Bell is only attainable in Europe.
However, whilst it is only possible to get the Costa vacuum bell in one size; 10 inch vacuum bell intended for male adults 5'7 or taller.
The Klobe vacuum bell comes in 5 different sizes:
The Large Vacuum Bell, diameter about 10", for male persons taller than approx. 5´ 7" (1.70 meters)
The Small Vacuum Bell, diameter about 7.5", for person taller than approx. 4´ 7" (1.40 meters)
The Small Vacuum Bell Type Bodybuilder for bodybuilders and special applications
The Mini Vacuum Bell, diameter about 6.3", for children taller than approx. 3´ 5" (1.04 meters) The Vacuum Bell for women
Please follow these links for more information on the Vaccum Bell and the treatment of Pectus Excavatum.
Subscribe to:
Posts (Atom)
