Monday, 25 April 2011

Abstract: The vacuum bell for treatment of pectus excavatum: an alternative to surgical correction?

OBJECTIVE:
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.

Source: Haecker FM, Mayr J. Department of Pediatric Surgery, University Children's Hospital, P.O. Box, CH 4005 Basel, Switzerland.

Sunday, 18 July 2010

Discussion

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.

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.

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 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.

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.

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.

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

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.

Saturday, 20 June 2009

How to Buy a Vacuum Bell

If you are interested in buying a vacuum bell, then you need to get in contact with the manufacturer by email.

Costa Vacuum Bell - costapectus@yahoo.com

Klobe Vacuum Bell - webmaster@trichterbrust.de

Simply state that you are interested in purchasing their product, and tell them you height and weight. They will promptly respond to your query with more information to help you decide whether their product is right for you.

You should also be aware that both manufacturers require that you consult a medical doctor before buying their product. Whilst Costa will accept your word, Klobe, will not sell you his product until you provide him with written permission from a medical doctor.
For more great information on the Vaccum Bell and the treatment of Pectus Excavatum please visit www.whatispectusexcavatum.com.

Medical Information Regarding the Vacuum Bell

Bending moments: The vacuum pulls the breastbone from its caved-in position into a raised position. The cartilaginous rib ends and costal arches, which are attached to the breastbone, are also pulled into a raised position. Simultaneously and with equivalent force, the rims of the vacuum bell press on the human body. The stress of these concurrent forces produces bending moments, primarily in the breastbone area and at the funnel edges. The bending moments at the funnel edges are counterbalanced by the anchorage of the ribs to the spinal column (backbone). These bending moments transform the cartilaginous rib-endings and costal arches, and the two moveable breastbone-hinges. Correction of the funnel is brought about primarily by their transformation.

Lifting of the funnel involves a 3-part process effecting the bones, cartilages and ligaments of the
ribcage: an initial, reversible (elastic) deformation; a gradual, permanent transformation;
and micro-ruptures, most likely occurring at the beginning of the treatment. Until these ruptures heal, the patient’s ribcage will experience a slight temporary loss of firmness.

The funnel's return to its concave position upon removal of the vacuum bell might be explained via the analogy of a competition between the ribcage's firmness and the pull of muscles, including the diaphragm. Optimal responses to therapy appear to result from lifting the funnel slowly and continuously in such a way that the teporary losses of firmness in the ribcage are kept to a minimum.

Gradual progress is best: It should take some time (even 2 to 4 weeks) for the chest to be lifted to the degree that the funnel comes into contact with the viewing glass. The inward-pulling muscles, such as the diaphragm, become stretched by lifting the chest wall. As a result of the complete duration of treatment, these muscles grow accustomed to their new position and
to pulling the funnel less forcefully. In many cases, this growing process takes longer than any other part of the treatment.

Exercises to Help with Pectus Excavatum Treatment

To supplement the use of the Vacuum Bell, the following exercises may help improve posture,
leading to improved funnel appearance:

Exercise one:
The patient takes a deep breath. Hands are placed behind the head and fingers interlocked. The
elbows are pulled back (extended) as much as possible and the head needs to remain upright. This stretches the front side of the chest and strengthens the upper back muscles.

Exercise two:
Once the posture of exercise one has been properly attained, the patient slowly bends from the
hips forward down to a horizontal position, holds that position for about five seconds, and then
slowly straightens back up again. It is very important that during the exercise the elbows are
maintained in the original extended position. Also, the neck should not be flexed during this
procedure. In other words, when the patient reaches the horizontal position, his spinal cord should be straight and not flexed at the cervical (neck) region. This exercise strengthens the lower back muscles.

Exercise one (by itself) should be done approximately five times per day.

Exercise one and two together should be done two times per day.

Exercise two may be especially difficult to complete. It may take several days (or weeks) until a patient is capable of performing it. (In some cases patients might not be able to perform it at all,
perhaps because the upper body is too long.)

Before attempting these exercises, patients should seek approval from their medical doctor that such exercises are appropriate and safe (e.g., these exercises may not be appropriate for patients with slipped discs in the spinal column or other conditions) If the patient is not allowed to perform these exercises (or should not be capable of performing them), he might ask a physical therapist for substitute exercises.

The final purpose of these exercises is to get a straighter (“better”) posture and to support the
Vacuum Bell's work. Exercise two is especially important to get the lower back
muscles strong enough to maintain the appropriate posture. Some patients are able to achieve this improved posture within one or two months.
For more information on the exercises which will help with Pectus Excavatum please visit www.whatispectusexcavatum.com.

Possible Course of Treatment

To begin with the patient should be examined by a licensed physician (medical doctor) to
make sure there are no contraindications against using the vacuum bell. Also, the first application of the vacuum bell should be supervised by medical personnel. The vacuum bell should be fitted while the patient lying in a horizontal position; the fit should be snug and comfortable. The patient pumps under supervision of medical personnel in accordance with the physician’s recommendation. In doing so, the patient should experience only minimal discomfort. With the vacuum applied the patient can try carefully to stand up and walk around. An application of 15 minutes should be sufficient for the first treatment, at the end of which a final check-up should be made. Subsequently, the vacuum bell can be handed over to the patient.

The patient can conduct subsequent treatments at his own convenience and in the comfort of his own home. During the early course of treatment, if the patient desires, he can take a break from treatment, consisting of a few days, in order to overcome chest soreness (a sensation similar to that caused by aching muscles). As soon as the chest becomes accustomed to the lifting of the funnel, it is feasible for the patient to apply the vacuum bell more often (shorten the amount of time elapsing between the single treatment sequences) and to extend the treatment-time to several hours per day. In the early states of treatment medical check-ups should be made every week, later every month or every quarter. The day on which the funnel remains in a sufficiently elevated position since the previous treatment marks an important development. From this point, treatment should continue for about one year in order to ensure that the progress made up to this point does not recede.

In conjunction with this treatment, physiotherapeutic exercises, especially those designed for
expanding respiratory volume as well as those designed for stretching the upper body, can have a significant influence on improving the physical appearance of the funnel chest patient.

What is a Vacuum Bell?

The vacuum bell is a medical device used for the treatment of pectus excavatum; an common chest defect (also known as funnel chest). The vacuum bell is typically used to treat cosmetic problems associated with the condition, as symptomatic cases of pectus excavatum; causing breathing or circulatory problems, are typically more severe, and will most likely require surgery.
The vacuum bell was invented by a German engineer named Klobe, and is sold online in Europe by Klobe himself. It is also possible to purchase a vacuum bell from an american manufacturer; Costa.
 

Differences between the Kolbe and Costa Vacuum Bell:

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 identicle 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 metres)

The Small Vacuum Bell, diameter about 7.5", for person taller than approx. 4´ 7" (1.40 metres)

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 metres)

The Vacuum Bell for women


Clinical Trials:

A study of 34 patients in 2006 (31 male and 3 female), aged between 6-52 years, who used the bell for 1-18 months showed immediate improvements. All of the patients recieved clinical examination, 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 unavailable, but up to this point, research appears promising.
For more great information on the Vaccum Bell and the treatment of Pectus Excavatum please visit www.whatispectusexcavatum.com.