Diaphragm Pacing: What we Learned since the First Implant Raymond P Onders MD FACS Cindy Kaplan MSN Mary Jo Elmo CNP University Hospitals Case Medical Center Department of Surgery 11100 Euclid Avenue Cleveland, Ohio 44106 Phone: 216-844-8594 Fax: 216-983-3069
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Diaphragm Pacing:What we Learned since the First Implant
Raymond P Onders MD FACS
Cindy Kaplan MSN
Mary Jo Elmo CNP
University Hospitals Case Medical CenterDepartment of Surgery11100 Euclid AvenueCleveland, Ohio 44106Phone: 216-844-8594Fax: 216-983-3069
• 100% success in meeting tidal volumes for successfully implanted patients
• Over 300 cumulative years- longest 13 years• 100% had improved speech and more normal breathing• 100% increased sense of independence• 100% of patients prefer DP over ventilators
Christopher Reeve “Superman”Second patient implanted
Pediatric DP Implantations- Now WorldwideSpain, US, Canada, Norway, Germany, Italy, Saudi
Arabia, Jordan
• Age 5-17, weight as low as 15 Kg
• Time on MV 11 days to 7 years
• 12 additional children since article- youngest 2 years old
Other Pediatric Implantations:SMA
Pompe
Early Implantation and Neuroplasticity in SCI patients
• Patients have gone from Mechanical Ventilators to DP to volitional breathing
• DP electrodes functions as EMG to assess recovery
• Functional Electrical Stimulation can lead to recovery- improves spinal cord environment
Prior to DP: No EMG Activity
After DP Conditioning: Recovery of Natural Function
Large burst activity
SCI Conclusions: Nobody Chooses to go Back to Ventilators
Replacing the Ventilator- Changes the life of a SCI patient
Can delaying a ventilator do the same in ALS?
The First Child: The boy who came back from heaven
Cannot skydive with a ventilator
Delaying Ventilators in ALSInitial concept after 2nd SCI patient
• ALS is UMN and LMN• DP overcomes UMN loss of control• DP conditions the diaphragm before failure
• Follow diaphragm EMG’s, Sleep Studies• Monitor CO2
• Breathing Patterns– OK to use Cough Assist, Vest, NIV, etc.
Why Improved Survival with DP and PEG? DP Augments Respiration by Increasing
Respiratory Compliance• Compliance related to atelectasis and work of breathing• Patients report an easier sense of breathing• Peri-operative measurement of respiratory system
compliance in group of patients gave 23% increase with stimulation
Patient Without DPS With DPS Change
01-12p 50 68 36%
01-14p 59 68 15%
01-15p 63 75 19%
01-01 59 72 22%
Respiratory System Compliance (ml / cm H2O)
*Onders, Elmo et al , Chest 2007
Simultaneous ProceduresFeeding Tubes
• Both regular PEG and low profile gastrostomy successfully placed
• Cosmesis of standard PEG is a major reason patients refuse PEG
• 117 HDE patients simultaneous DP/PEG
• 114 chose low profile tube
Pros Cons of Low Profile Tube
• More post operative pain with either tube• Slightly more discomfort than standard
PEG• Need to attach an extension for each use• Limited by abdominal girth• Significantly more aesthetically pleasing• Does not get tangled with clothing• Preferred by most patients
What is a Suprapubic Catheter• Common surgical procedure where a catheter is inserted
through the abdomen and into the bladder under cystoscopic guidance
• Performed under light sedation in <30 min• Drains urine from the bladder• Held in place by a balloon• Connected to a closed drainage system
Urinary Function in ALS• Not extensively studied• Commonly reported “urination not usually
affected”• Two studies in ALS
– 41% (22 of 54) - symptoms of nocturia, feeling of incomplete empting, frequency and post-micturition dribble
– urinary incontinence stated a high impact on their quality of life
• Disease progression/physical limitations– Ability to stand/walk/move to commode– Caregiver availability– Time
• Non-invasive methods to assist urination are preferred
MDA/ALS Newsmagazine 2013 pgs1-4
SPC and DP• 18 Total ALS patients since October 2012
– 3 patients had pre DP placement– 1 patient had post DP placement
• 1 month to 6 years with average of 1 year• 8 women - 10 men• Wheelchair bound
– Reasons for choosing catheter • Difficulty getting to commode• Problems with condom catheters (skin breakdown, erosions,
smells)• Smells from accidents• Problems with night time urination• Affecting social life
Patient FeedbackComplications
• Urinary Tract Infection• 3 patient reports of spasticty• 1 patient –catheter pulled out bladder,
chose to under go repeat placement• 1 patient – site slow to heal
Patient FeedbackBenefits
• No skin breakdown• No odor• Improved uninterrupted sleep• Easier to leave the house• Easier to care for than transferring to commode• Increased fluid intake• More self respect
Benefits Continued
• Every patient wished they had it sooner• Every patient would recommend to others• Every patient would do it again• Every patient said benefits outweigh the
negatives
Case Example- 1FVC 65%, MIP of 33, elevated Right diaphragm,
Paradoxical movement under fluoroscopy, pCO2 of 46, Good phrenic EMG on right
Excellent diaphragm movementNo longer paradoxical movement
Case Example-2• 61 -year old male- former marine• Onset – June 2006• Results 04/20/2010
– FVC 19% (was 41% Feb 2010)– MIP/MEP 12.8/13%– ABG: 7.43-38-77– CXR – Elevated left
hemidiaphragm– PNCT – No Response bilaterally– Minimal bulbar – no weight loss– NIV at night– Tracheostomy mechanical
ventilation – unacceptable
Not a Surgical CandidatePoor Movement
Case- 3
• 44 yo male• Ex-football player• Diagnosed ALS June 2011• NIV at night, SOB during day• Increasing dysphagia, lost 12 pounds• FVC 84%, MIP 48, pCO2 45
Case 3: Diaphragm Analysis
Post-op Diaphragm EMGOn NIV
Off of NIV
Two weeks post implant
• Can lie flat• Significant improvement in Diaphragm
EMG
Conclusions• DP can be implanted safely in ALS patients with
chronic hypoventilation and stimulatable diaphragms
• DP is a tool to help Augment Respiration • Understanding and augmenting respiration
improves safety of other procedures to improve quality of life– Low profile gastrostomy tubes– Supra-pubic catheters
AcknowledgementsWithout Funding No Research
•University Hospitals Case Medical Center•Rehabilitation Research Service of the Department of VA•FDA- Orphan Drugs•Prentiss Foundation•The Winters Family for ALS•Feintech Family•The Bailey Foundation •Kali’s Cure