First Canadian Site For New Breathing Pacemaker
Posted 23 January 2007 - 10:10 AM
A team of clinician researchers and surgeons from Vancouver Coastal Health Research Institute (VCHRI) and the University of British Columbia are piloting life-changing technology that enables mechanically ventilated patients to breathe on their own again.
On January 8, at Vancouver General Hospital, the team implanted a unique electronic device into a quadriplegic man from Alberta. He is now able to breathe on his own for the first time in nearly five years. This technology is a first for Canada, with Vancouver the second site in the world to become a trial centre. A critical research grant from the Rick Hansen Foundation and BC Rehab supported the procedure.
The technology, known as DPS or “diaphragm pacing system” frees people with nerve damage from spinal cord injury, and illnesses such as ALS, from the physical constraints and lifestyle restrictions of ventilator dependence. The process involves the placement of tiny electrodes onto the diaphragm through laparoscopic surgery. The electrodes are then threaded to a small external battery pack (the size of a TV remote control) that signals the diaphragm to contract, pulling air into the lungs. After a period of conditioning, the diaphragm is strengthened to a point where a person can remain ventilator free 24/7.
Diaphragm pacing was developed in Cleveland, Ohio by Dr. Raymond Onders and biomedical engineers at Case Western Reserve University. To date, Dr. Onders and his team have successfully performed the surgery on 46 patients, 13 of whom have ALS. The late actor Christopher Reeve was the third person to receive the surgery in 2003.
Dr. Jeremy Road, a specialist in Respiratory medicine at Vancouver General Hospital, scientist at VCHRI with the Respiratory & Critical Care research group, medical director of the Provincial Respiratory Outreach Program, and professor in the Faculty of Medicine at UBC and Dr. John Yee, surgeon in Division of Thoracic Surgery at UBC and VGH and surgical director of the Lung Transplant Program for the province of British Columbia, are the physicians responsible for bringing the pilot study to Vancouver Coastal Health Research Institute and VGH.
“I was struck by how life changing this procedure is, ” said Dr. Jeremy Road, principal investigator of the research trial. “Mechanically ventilated patients almost always have severe impairments for smell, taste, and speech. With diaphragm pacing, they are able to regain their sense of taste and smell, improve speech and live life with a much higher level of independence.”
Drs. Road and Yee believed Vancouver General Hospital would be an ideal site to study this technology because of its world leading programs in thoracic surgery and spinal cord care.
“This project is an example of how advances in the basic science of muscle physiology can be combined with biomedical engineering and minimally invasive surgery to bring practical solutions that improve the quality of life for patients,” said Dr. John Yee who trained with the team in Cleveland in order to bring this procedure to B.C. “We are privileged at Vancouver Coastal Health to have world-leading research in spinal cord injury and dedicated clinical teams in respiratory therapy, rehabilitation medicine, and surgery. This project adds yet another component to the multi-disciplinary platform of care and research available for patients at VCH via Vancouver General Hospital, GF Strong, our research institute, and our private partners in the community.”
Health Canada has granted the research team permission for ten research surgeries, open to patients from across Canada with spinal cord injury who are ventilator dependent. As a clinical trial, costs (approximately $24,000 Cdn including the device) are not funded under Medicare.
The Rick Hansen Foundation, in cooperation with BC Rehab, has funded this first surgery in the research project through the VGH & UBC Hospital Foundation.
“This is history-making. It is exciting to see Canada's leadership role in research to ensure procedures like the DPS become available to people with spinal cord injury. We are pleased to support this innovative procedure that applies knowledge and technology to improve lives in an immediate way," said Rick Hansen, President and CEO, Rick Hansen Foundation. “Thank you to our partners at Vancouver Coastal Health Research Institute, BC Rehab and the BC Paraplegic Association for their leadership and collaboration in making this ‘first in Canada’ opportunity possible. Opportunities like this provide hope to many living with spinal cord injury and their families.”
As part of its mission to accelerate improvements to the quality of life of people with spinal cord injury, the Rick Hansen Foundation also provided grants to assist Dr. Yee’s training in Cleveland for this procedure, enabling the trial to ultimately come to Canada. The Foundation also provided grants to the first two Canadians to benefit from this procedure as participants of the initial study in Cleveland.
The surgical team members, including Dr. Ray Onders who flew up for this first procedure, have all donated their time, and Synapse Biomedical, the company who makes device, donated the equipment ($11, 580 USD).
NOTE TO EDITORS: Media Interviews are available this morning (January 15) with Dr. Jeremy Road, Dr. John Yee, and patients Robert (Bob) Blair (Red Deer, Alberta) and Daniel Leblanc (Vancouver). Mr. Leblanc received his surgery in Cleveland under Dr. Yee and Dr. Onders in 2006. Call to arrange. B-roll of the January 8 surgery is available.
Diaphragm Pacing System (DPS)
* This program is still in clinical trial stages. Health Canada has granted permission to enrol 10 patients in total – for high-level spinal cord injury dependant on mechanical ventilation.
* The surgery is done through a minimally invasive procedure. Currently, in Cleveland, the patient only requires a one-night stay. For the VCHRI Clinical trial, patients are requested to enter the hospital the day prior to surgery and to remain for one day of observation after surgery. It is anticipated that this procedure will soon be performed on an outpatient day-surgery basis.
* The first surgery took place January 8, 2007
* The patient is from Red Deer, Alberta. Several BC patients are under evaluation at this time. There has been considerable interest from patients and their physicians from across Canada.
The cost for the procedure, including the device is approximately $24,000. As a clinical trial, costs are not funded under Medicare.
* For this first procedure:
o BC Rehab and the Rick Hansen Foundation donated money to cover patient costs. (The Rick Hansen Foundation, together with BC Rehab and BC Paraplegic Society also provided funding to send the first two Canadian participants in the Cleveland study.)
o The surgical team has donated their time.
o Synapse Biomedical, the company who makes the device has donated the equipment (which costs $11,580 US). The company also flies a team in post-surgery to assist the patient, caregiver, and rehab team during the initial period of diaphragm muscle training. They do this at their own cost as a part of product support.
* VGH & UBC Hospital Foundation is seeking funding for the next nine procedures in the clinical trial.
* Age 19 years or older
* Cervical spinal cord injury dependant on mechanical ventilation
* Clinically stable following acute spinal cord injury
* Bilateral phrenic nerve function clinically acceptable as demonstrated with EMG recordings and nerve conduction times
* Diaphragm movement with stimulation visible under fluoroscopy
* Clinically acceptable oxygenation on room air (>90%)
* Hemodynamically stable
* No medical co-morbidities that would interfere with the proper placement or function of the device
* Committed primary caregiver
* Negative pregnancy test in females of child-bearing potential
* Informed consent from patient or designated representative
* Diaphragm pacing enables a significant improvement in quality of life. Patients are freed from being tethered to a 55-pound machine that impairs their sense of taste and smell and reduces their ability to speak.
* In addition to helping people with spinal cord injury, Diaphragm Pacing may also have applications with other illnesses such as muscular dystrophy and ALS – 13 ALS patients have received this procedure in Cleveland. At this time, VCHRI does not have permission to include ALS patients in the study.
* Freedom from mechanical ventilation decreases cost, increases housing options, and decreases family burden. The mean cost of maintaining mechanical ventilation is $180,120.00 with the upward scale reaching $1,080,000.00. Mean yearly out of pocket expenses to families for maintaining mechanical ventilation is $10,356.00 (Moss, 1996). The US based study led by Dr. Onders et al describes the cost savings of $13,000.00 monthly for one patient with spinal cord injury who was successfully weaned off the ventilator to full time pacing. There are fewer long-term care facilities that will care for ventilated patients opposed to a non-ventilated patient. Caring for the patient is a major burden, life altering and costly time (Moss, 1996). (Above costs are based on US cost analysis and in US dollars.)
Vancouver General Hospital is the largest teaching, research and referral hospital for trauma and specialized care in British Columbia, treating one in twelve patients from across the province. The Thoracic Surgery and Spine programs at VGH are centres for excellence and referral centres for the entire province of BC and beyond.
Vancouver Coastal Health Research Institute (VCHRI) is the research body of Vancouver Coastal Health and the fourth largest research institute in Canada. In academic partnership with the University of British Columbia, VCHRI brings innovation and discovery to patient care, advancing healthier lives in healthy communities across British Columbia, Canada, and beyond.
University of British Columbia researchers attracted $485.6 million in overall research funding in 2005/06. UBC ranks in the top 10 of North American universities in creation of spin-off companies, has particular strengths in biotechnology, and generates more U.S. patent applications than any other Canadian institution. UBC has ranked among the top 40 universities in the world for the past four years.
VGH & UBC Hospital Foundation is a registered charity that raises funding for the latest, most sophisticated medical equipment, world-class research and improvements to patient care for Vancouver General Hospital, UBC Hospital, GF Strong Rehab Centre and Vancouver Coastal Health Research Institute. For more than 25 years, the Foundation and its donors have been a bridge between the essential health care governments provide and the most advanced health care possible.
Established in 1988, the Rick Hansen Foundation is a registered charitable organization that works to create more accessible and inclusive communities for people with a spinal cord injury, and supports the search for a cure. The Foundation achieves its goals by connecting the people and resources that make innovation possible. To date, the Rick Hansen Foundation has had an impact of over $178 million on spinal cord injury research and quality of life initiatives.
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