The Vacuum Bell for Conservative Conservative

Transcription

The Vacuum Bell for Conservative
Treatment of Pectus Excavatum
The Basle Experience (2003-2015)
Objective:
To report on
• My 12 years experience with conservative
treatment of pectus excavatum
• The intraoperative use of the vacuum bell to
elevate the sternum during the Nuss
procedure
Frank-Martin Haecker, MD
Professor of Pediatric Surgery
• Additional indications to use the vacuum bell
Department of Pediatric Surgery
University Children‘s Hospital Basel (CH)
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© UKBB, Advanced Pectus Workshop 2015, F.-M. Haecker
Conservative Therapy of PE
• Physiotherapy & sports
• Magnetic mini mover
(Harrison M et al., J Pediatr Surg 2010/2012)
Conflict of Interest:
Nothing to disclose
• Vacuum bell
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Buenos Aires, September 2013
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Conservative Therapy of
Pectus excavatum (PE)
• Mild degree of PE
• Patients want to avoid operation
• Patients are reluctant to undergo
surgery because of the pain associated
with the operation
• Risk of „imperfect“ results
• Risks/complications of the operation
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Conservative Therapy
History of the Vacuum Bell
dental braces
helmet therapy
• Deep exspiration
(e.g. playing the trumpet)
• Intensive inspiration &
exspiration
• Tape dressing
Pfaundler & Schlossmann:
Handbuch der Kinderheilkunde,
1910
• „best results due to the effect
of the air diluted space“
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The Vacuum Bell
Effect of the Vacuum Bell
• Elevation of the sternum
different models
• Elevation of the sternocostal joint
Schier F, Bahr M, Klobe E; J Pediatr Surg 2005
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19cm
26cm
The Vacuum Bell
The Vacuum Bell
• Price of the device:
~620€
• Manufacturer: E. Klobe (Germany)
• FDA approval since May 2012
16cm
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• Instruction for
application by a
physician
• Daily application by the
patient oneself
• Application two times
per day (~30 min.)
• No routine analgetic
medication
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Therapy of PE
Application of the Vacuum Bell
application of the vacuum bell
Indications
• Conservative treatment of PE
• Preoperative before the Nuss procedure
video
(„pretreatment“)
• Intraoperative during the Nuss procedure
during advancement of the introducer
during flipping of the bar
• Postoperative after surgical procedure
• .........
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Contraindications
Side Effects
• Skeletal disorders
(e.g. Osteogenesis imperfecta,
Glisson´s disease, etc.)
• Vasculopathies (e.g. Marfan´s
syndrome, abdominal aneurysm)
• Cardiac disorders
• Coagulopathies
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•
•
•
•
•
Hematoma
Petechial bleeding
Back pain
Paraesthesia of the upper extremities
Rib fractures
(never seen in our patients group)
• .........
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Side effect of
the vacuum bell
Therapy of PE
the vacuum bell - patients perception
• Pain around the sternum when starting
the application (~1.-5. applications)
• „strange“ sensations („tension“)
• Moderate subcutaneous hematoma
• Transient paraesthesia of the UE (2 pts.)
• Recurrent dorsalgia (1 pt.)
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• No routine analgetic medication !!
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5-year-old boy
Examinations before
Conservative Therapy of PE
• Patients History
• Clinical Examination
(focus on associated malformations)
• Measurement of depth of PE
• Foto documentation
• ECG / echocardiography
before vacuum bell therapy
(depth of PE: 3.5 cm)
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after 4 months
5-year-old girl
after 8 months
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6-year-old boy
before vacuum bell therapy (depth of PE: 3.3 cm)
after 3 months
after 6 months
after 9 months
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after 6 months (depth of PE: 1.1 cm)
10-year-old boy
13-year-old girl
after 3 months
after 6 months
after 3 months
after 9 months
after 9 months
3 months after
cessation
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after 17 months
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45-year-old patient
16-year-old boy
before therapy (depth of PE: 2,5 cm)
before therapy (depth of PE: 4.5 cm)
after 10 months (depth of PE: 2.0 cm)
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Localized Application (15y)
after 12 months (depth of PE: 0,5 cm)
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Localized Application (14y)
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9-year-old boy
Combined Application
after 10 months
after 16 months
24 months after
therapy
36 months after
therapy
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15-year-old boy
Vacuum Bell Therapy
Study Population
• 347 patients (274 male, 73 female
started with the application of the
vacuum bell (9/2003-02/2015)
• Individual success of therapy
• Nuss procedure: 104 patients
(2000-12/2014)
after 24 months
after 8 months
after 35 months
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Vacuum Bell Therapy
Vacuum Bell Therapy
Study Population
Study Population
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02/2015
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2014
2013
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2012
20
2010
2011
2009
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2008
2007
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2006
2005
5
2004
2003
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Vacuum Bell Therapy
Retrospective Study
• Depth of PE: 1.5-5cm
• Permanent elevation of PE > 1.5cm after
3 months: 105 patients (79%)
• Permanent elevation to normal level
after ~ 18 months: 18 patients
• Success of therapy faster visible in
younger patients
• Discontinuation (= failure)
of application: 13 pts.
• 133 patients (110 m, 23 f)
• Age between 3 and 61 years
(mean age 16.21y)
• Daily application: 107.9 min. (av.)
• Duration of application:
20.5 months (range, 1-69 months)
• Cessation of application:
21.8 months (range, 6-69 months)
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Discontinuation of Application
• 13 patients (11 m; 2 f)
• 12 patients: Nuss procedure
(mean age 15.8y)
• Duration of application: 2-42 months
(average: 15.7 months)
15y old boy
(depth of PE: 2cm)
Nuss procedure after 30 months
• Cause of discontinuation:
Insufficient success
Decreasing motivation
12y old boy (depth of PE: 3.1 cm)
after bar removal
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14y old boy
(before surgery)
• 24 patients (19 m; 5 f)
• 17 patients: Nuss procedure
(mean age ~15y)
• Duration of application: 2-42 months
(average: 15.7 months)
• 17 patients (Nuss procedure): 18.7 months
• 7 patients (no further treatment): 10.8 months
after surgery
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Intraoperative Application
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• 50 patients (39 m, 11 f)
(mean age 14.95y)
• Haller index: 5.05 (range, 3.25 to 7.4)
• Duration of surgery: 58 minutes
(range, 45 to 92 minutes)
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The Vacuum Bell
The Vacuum Bell Therapy
intraoperative application – side effects
Problems
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•
•
•
•
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Age Specific Difference
Problems
definition of success
after 6 months
(depth of PE: 1.2 => 0.6cm)
Definition of success?
Age specific differences of success?
Therapy before/during/after puberty
Patients with asymmetric PE/Costal fl. ?
Objective assessment of depth of PE?
Treatment Protocol – Monitoring of
application – Safety of application
• Long-term results (more than 10 years)?
• Cost of treatment
the „perfect“ patient
11-year-old boy
7-year-old girl
36 months later (15y)
6 months & 18 months
after cessation
after 12 months
(depth of PE: 0.4cm)
36 months after cessation
after 3 months*
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after 9 months
after 15 months
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the „difficult“ patient
the „perfect“ => the „difficult“ patient
17-year-old boy
6-year-old girl
after 15 months
after surgery
after 16 months
after 43 months
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Method of Assessment
Method of Assessment
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Method of Assessment of
Depth of PE
Method of Assessment of Depth of PE
after 6 and 12 months
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Assessment of Applicated
Pressure
Pressure
FMF device
Pressure of treatment
Pressure at first application
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Weiss S: Aufbau eines Messsystems zur therapiebegleitenden Bestimmung der Flexibilität einer
Trichterbrust; Bachelor Thesis an der FHNW (2013)
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Pressure
(11 year old boy)
(17 year old boy)
Maximum of elevation (~ 1.0cm) at a
negative pressure of ~ -140 mbar
Maximum of elevation (~ 1.8cm) at a
negative pressure of ~ -115 mbar
x elevation of the sternum
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• Start of the clinical application after
IRB approval as a pilot study
• Patient in supine position
• Fixation of the device on the patients‘
vacuum bell
Pressure
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Pressure
Pressure
+ pressure
x elevation of the sternum
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+ pressure
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Therapy of Sternal Fx
Pressure
the vacuum bell – first report
Correlation between sternal elevation
and pressure under the vacuum bell
8-year-old boy
closed reduction
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8-year-old boy
8-year-old boy
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7d after closed reduction
9 months after
closed reduction
17d after
closed reduction
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Vacuum Bell Therapy
The Vacuum Bell - Conclusion
• Easy application
• Good acceptance by both pediatric
and adult patients
• No relevant side effects
• Additional therapeutic tool before,
during and after the Nuss procedure
• Improvement of body control
• Long-term results missing
• Costs of treatment ?
Case no. 2 - CHKD
after 6 months
application: 60min. twice/day
no problems/side effects
Result: excellent per patient and mother
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Courtesy R. Obermeyer, Norfolk (USA)
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Courtesy M. Martinez Ferro,
Buenos Aires (Argentina)
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Multicenter Study
• Children’s Hospital of the King’s Daughters,
Norfolk, USA (R. Obermeyer, R. Kelly)
• Hospital Privado de Niňos, Buenos Aires,
Argentinia (M. Martinez Ferro)
• Children‘s Hospital McGill University,
Montreal, Canada (J.-M. Laberge)
• Université Jean Monnet, St. Etienne, France
(M. Lopez, O. Tiffet)
• University Children‘s Hospital, Basel,
Switzerland
• ...................
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Thank You for Your Attention !
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The Vacuum Bell for Conservative Conservative

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