New surgical procedures should be monitored after their introduction. The
approval process should decide the type of monitoring to be undertaken.
• As a minimum, audits of indications and outcomes should be done.
• Access to reliable surgical data (local and global), organised in such a
way that performance comparisons can be made.
• It is highly desirable to coordinate and standardise any study designs,
e.g. outcomes measured in the same way for case series and audits
across hospital services or as done in previous studies.
If an audit or controlled clinical study is being contemplated, consider
whether this can be done as part of a multi-centre study.
• Develop/amend internal processes for the reporting of any adverse
events from new procedures and consider external processes e.g. as
part of multicentre audits or advising the Therapeutic Goods Authority
or the New Zealand New Technology Committee re problems with
devices.
Monday, January 28, 2008
THE Australian Story - ASERNIP-s ROLE
2.1 PriorEvaluation
Most techniques new to Australia and New Zealand will have been evaluated
or at least implemented elsewhere in the world first. Issues that should be
considered include:
• Has the technique been previously evaluated?
Hospitals/health services should establish whether an assessment has
already been done through international or national systematic review
or Health Technology Assessment (e.g. INAHTA– International
Network of Agencies for health technology assessment, ASERNIP-S –
Australian Safety and Efficacy Register of New Interventional
Procedures - Surgical, Cochrane Collaboration, MSAC – Medical
Services Advisory Committee), clinical studies, industry reports,
laboratory testing or animal studies, reports of case series overseas,
reports of experiences of the techniques in Australian and New
Zealand facilities (see Appendix 1 for a list of relevant organisations
and their web-sites).
• How reliable is the evaluation?
Interpretation of assessments should include the likely robustness of
the evidence e.g. type of study design, were studies large enough to
show reliable results for morbidity and mortality; were there possible
confounding factors, such as the age of patients?
Most techniques new to Australia and New Zealand will have been evaluated
or at least implemented elsewhere in the world first. Issues that should be
considered include:
• Has the technique been previously evaluated?
Hospitals/health services should establish whether an assessment has
already been done through international or national systematic review
or Health Technology Assessment (e.g. INAHTA– International
Network of Agencies for health technology assessment, ASERNIP-S –
Australian Safety and Efficacy Register of New Interventional
Procedures - Surgical, Cochrane Collaboration, MSAC – Medical
Services Advisory Committee), clinical studies, industry reports,
laboratory testing or animal studies, reports of case series overseas,
reports of experiences of the techniques in Australian and New
Zealand facilities (see Appendix 1 for a list of relevant organisations
and their web-sites).
• How reliable is the evaluation?
Interpretation of assessments should include the likely robustness of
the evidence e.g. type of study design, were studies large enough to
show reliable results for morbidity and mortality; were there possible
confounding factors, such as the age of patients?
THE Australian Story - MSAC version
The Medicare Benefits Schedule (MBS) has evolved over time in response to changes in medical practice. Medicare benefits are payable in respect of a medical service listed in the MBS where that service is:
Medicare item 35003 relates to the performance of cervical or upper thoracic sympathectomy by any surgical approach (irrespective of whether it is conducted by open exposure or endoscopically). Sympathectomy has been listed on the MBS for over three decades, and permitted by any surgical approach since 1991.
The Medical Services Advisory Committee (MSAC) was established in 1998 to advise the Minister for Health and Ageing on the strength of evidence pertaining to new and emerging medical technologies and procedures in relation to their safety, effectiveness and cost-effectiveness and under what circumstances public funding should be supported. MSAC has never considered this procedure, as it was listed on the MBS prior to MSAC's formation, and is therefore not a 'new and emerging medical technology'.
The Government relies on the advice of the medical profession in relation to the clinical relevance of procedures already listed on the MBS. If the Royal Australasian College of Surgeons were to formally advise the Government that it no longer regards this procedure as being clinically relevant, the Government would take appropriate action in relation to the MBS.
Mia: Surgeons performing the surgery ARE Fellows of the Royal Australasian College.
- provided by a medical practitioner, and
- a clinically relevant service (generally accepted in the medical profession as being necessary for the appropriate treatment of the patient).
Medicare item 35003 relates to the performance of cervical or upper thoracic sympathectomy by any surgical approach (irrespective of whether it is conducted by open exposure or endoscopically). Sympathectomy has been listed on the MBS for over three decades, and permitted by any surgical approach since 1991.
The Medical Services Advisory Committee (MSAC) was established in 1998 to advise the Minister for Health and Ageing on the strength of evidence pertaining to new and emerging medical technologies and procedures in relation to their safety, effectiveness and cost-effectiveness and under what circumstances public funding should be supported. MSAC has never considered this procedure, as it was listed on the MBS prior to MSAC's formation, and is therefore not a 'new and emerging medical technology'.
The Government relies on the advice of the medical profession in relation to the clinical relevance of procedures already listed on the MBS. If the Royal Australasian College of Surgeons were to formally advise the Government that it no longer regards this procedure as being clinically relevant, the Government would take appropriate action in relation to the MBS.
Mia: Surgeons performing the surgery ARE Fellows of the Royal Australasian College.
Unstable blood pressure after sympathectomy
Risks
Side effects of sympathectomy may include decreased blood pressure while standing, which may cause fainting spells. After sympathectomy in men, semen is sometimes ejaculated into the bladder, which may impair fertility. After a sympathectomy done by inserting an endoscope in the chest cavity, patients may experience chest pain with deep breathing. This problem usually disappears within two weeks. They may also experience pneumothorax (air in the chest cavity).
Sympathectomy suppresses baroreflex control of heart rate
Endoscopic thoracic sympathectomy suppressed the baroreflex control of heart rate during pressor and depressor tests in patients with palmar or axillary hyperhidrosis.
Yurie T. Kawamata, MD* , Tomoyuki Kawamata, MD
, Keiichi Omote, MD , Eiji Homma, MD* , Tatsuo Hanzawa, MD* , Toshifumi Kaneko, MD
, and Akiyoshi Namiki, MD
2004 International Anesthesia Research Society
Endoscopic Thoracic Sympathectomy Suppresses Baroreflex Control of Heart Rate in Patients with Essential Hyperhidrosis
2004 International Anesthesia Research Society
Australian Story 3!
from: http://ets-sideeffects.net/index.html
TIMBO McCarty, an Australian/New Zealander who has been suffering from the side-effects of ETS for eight years and has been working on this website alongside me as well as helping organise meetings, had enough of the side-effects and committed suicide on October 29 at the age of 45. His Father and Mother asked me to put this on the website and to let everyone know that he had had enough. Timbo was always there for me as a friend to talk when I felt everything was getting to me. Timbo was also was a fighter. He wanted ETS surgery to be stopped and was depressed that the surgery is still being performed routinely. He was aghast that his surgeon, Dr Lin in Taiwan, who performed ESB (clamping of the T2 nerve), removed his clamps at a fee yet still performed reversals routinely even though so many people have come forward with complaints.....
This is the second suicide in two years from people who have had terrible side-effects.
TIMBO McCarty, an Australian/New Zealander who has been suffering from the side-effects of ETS for eight years and has been working on this website alongside me as well as helping organise meetings, had enough of the side-effects and committed suicide on October 29 at the age of 45. His Father and Mother asked me to put this on the website and to let everyone know that he had had enough. Timbo was always there for me as a friend to talk when I felt everything was getting to me. Timbo was also was a fighter. He wanted ETS surgery to be stopped and was depressed that the surgery is still being performed routinely. He was aghast that his surgeon, Dr Lin in Taiwan, who performed ESB (clamping of the T2 nerve), removed his clamps at a fee yet still performed reversals routinely even though so many people have come forward with complaints.....
This is the second suicide in two years from people who have had terrible side-effects.
Support groups for people who had sympathectomy and ended up with disabling side-effects
World Against Sympathectomy | http://www.truthaboutets.com/ |
The Sympathetic Association | http://home.swipnet.se/sympatiska/index3.htm |
Patients Against Sympathetic Surgery | http://www.ets-sideeffects.netfirms.com/ |
Radisson Group | http://www.noetsuk.com/ |
Family of Compensatory Sweating Sufferers | http://home.pchome.com.tw/family/vivi12175/ |
ETS Side Effects | http://www.geocities.jp/etscontroversialop/index.html |
Hyperhidrosis Forum | http://www.terra.es/personal8/hiperhidrosis/principal.htm |
Sympathectomy is prohibited for patients under 20 years in Taiwan. Why?
|   | |||
| Min-Huei Hsu Department of Neurourgery, Taipei City Hospital, Zhongxiao Branch Send letter to journal: Email Min-Huei Hsu
| Endoscopic thoracic sympathectomy (ETS) has come into widespread use for palmar hyperhidrosis. Side sffects after ETS was widely discussed in Taiwan society in the past few months. Lots of people in Taiwan suffer from hyperhidrosis palmaris. ETS is covered by the National Health Insurance, and patient billing for this operation does not exceed US$ 60. This is why this operation is so popular here 1 . Patients with severe compensatory sweating after ETS must change clothes several times a day (some patients complained that they change as often as 10 times a day), resulting in serious impact on work and social interaction. Patients suffering from such serious side effects in Taiwan have formed a support group based on an Internet discussion forum to request the government to take this problem seriously. Starting in October 2004, The Department of Health, Executive Yuan, Taiwan, has prohibited surgeons from performing this operation on patients under 20 years old. To our knowledge, this type of support group also exists in United States, England, Sweden, Spain and Japan (Table 1). ETS is a relatively safe and simple procedure. However the side effects are possibly devastating 2 . All physicians providing this service and all peoples preparing to undergo this treatment should know this well. | |||
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