Transcript Bariatric (Metabolic) Surgery must be “delivered” safely
John Hagen MD FRCS(C) Assistant Professor Surgery University of Toronto
Honorarium- Covidien Honorarium-Ethicon
Humber River Regional Hospital experience Development of Centers of Excellence in USA Surgical Review Corporation Surgical training
Community hospital in the north of Toronto Bariatric surgery program began in 1999 Laparoscopic bariatric surgery began 2004 Over 1100 laparoscopic gastric bypasses have been done with funding for 450 cases/year 5 surgeons Designated “Center of Excellence” by the Ministry of Health in Ontario
First 880 cases done with acceptable results Over a 6 month period September 2009 February 2010 there were 5 deaths within 30 days of surgery With the help of the coroner’s office, the program was shut down while an external review was done by a well known expert
Poor selection of patients Medical conditions not optimized prior to surgery Lack of integration between anaesthesia, internal medicine, surgery and bariatric clinic Inadequate post-op monitoring Diagnostic laparoscopy when problems occur not utilized enough
The program is up and running Application to become “ACS Center of Excellence” has been made Hiring of nurse practioners Integration of the bariatric clinic with specialists and staff What began as an “interest in laparoscopy” has been transformed into a program
Poor outcomes will not be tolerated
In the 1950’s and 1960’s results were less than ideal with small bowel bypass Weight loss occurred, diarrhea, liver disease and malnourishment High mortality rate Bariatric surgeons were not viewed favorably by their colleagues
1960’s-1990;s Bariatric surgery could be performed with few complications NIH recognized the effectiveness of bariatric surgery in its Consensus Statement of 1991
Celebrity patients- Carnie Wilson, Sharon Osbourne Number of surgeries per year exploded from 4,900 in 1990 to 140,000 in 2003 Then 200,000 cases in 2010 Insurance companies started raising red flags Some saw surgery as opportunity to fill OR blocks Laparoscopic surgeons wanted to add weight loss surgery to their repertoire
Some surgeons took a weekend course and had no bariatric program in place Higher mortality rate for inexperienced surgeons With no bariatric program, and poor follow up, weight regain occurred frequently
www.gastric-bypass-surgery-lawsuits.com
“Surgeon not properly trained or experienced” “Equipment not available for obese patients” “Failure for a surgeon to respond immediately when problems arise” “Surgery done for inappropriate reasons”
Establishment of Centers of Excellence Standards for training and resources The need to recognize the centers that perform well
1. The hospital must have a high level of commitment and a regular program of in service training 2. The hospital must perform 125 cases per year 3. There must be a Medical Director of Bariatric Surgery 4. A full team of specialists must be available 5. The hospital must have appropriate equipment
6. The bariatric surgeon must be board certified 7. Bariatric surgery is to follow standardized procedures and clinical pathways 8. There must be a designated nurse or physician who is involved in continued care 9. There must be availability of a support group 10. The practice must follow up on 75% of patients after 5 years and show outcomes
Walter J. Pories, MD, FACS Chairman of the Board Surgical Review Corporation
20
th
Century E=mc
2
21
st
Century Data = Power
1950 – 2000: Development of Bariatric and Metabolic Surgery.
Durable control of obesity with reduction of mortality Full, durable remission of diabetes and other co-morbidities independent of weight loss With remarkable safety
Preop 1 year 2 years 5 years 10 years 317 199 194 209 217
21155
16 years 211
106 lb
Mean Weight Mean % XS Weight Loss 0 67 69 57 51 55 Mean BMI 51 32 32 34 35 37
And Durable, Full Remission of Type 2 Diabetes Independent of Weight Loss
608 morbidly obese
146 Type 2 Diabetics 152 IGT “impaired” 121/146 (83%) euglycemic 150/152 (99%) euglycemic
Enthusiastic gratitude for the conquest of obesity and diabetes? No
Carriers: Who will pay for this?
Colleagues: can’t be true Variable outcomes in US Press reports of complications Increased litigation Unaffordable malpractice premiums Loss of access
Could not deny the advances Carriers develop Centers of Excellence Programs Multiple Standards Multiple Applications Inadequate databases Arbitrary Decisions No sharing of data Patients denied; surgeons hassled
It’s up to us…..
How shall we proceed?
To win: Must be able to document our results But we do not have the information Selected data were from major centers Overcome variable levels of care in U.S.
Without information We cannot improve We cannot defend
The Process Must Be
Credible Useful Clinically reasonable Economic Ethical/Confidential
Centers = Surgeons + Hospitals One level of excellence throughout US Full resources must be available Standardization of operations and care Required reporting of all cases A large, reliable database (BOLD) Data verified by site inspections Utilization of data for improvement of care, research, negotiations
OK. We can do it.
The American Society of Bariatric Surgery will develop its own Centers of Excellence Program Not so fast: Restraint of trade issues Legal vulnerability of the Society Credibility (Fox guarding the hen house)
A separate, non-profit, transparent organization Policy: Board of Directors with stakeholders on the Board Surgical Decisions: A Review Committee of experienced, respected surgeons Corporate Structure to manage the complex programs Nov. 2003: THE SURGICAL REVIEW CORPORATION
Clinical Quality and Compliance Strategic Alliances Operations Research
Total applicants 719 Hospitals, 1,235 Surgeons Centers of Excellence 233 Hospitals 458 Surgeons Applicant Patient Data Base 108,200+ patients Cost $8.75 per patient
Total # of patients Hospital Mortality 61,545 83 100% 0.14% 0.29% Operative Mortality at 30 days (83 + 98 = 181) Operative Mortality at 90 days ( 83+98+44= ) Re-admissions 191 225 3,018 Re-operations 1,325 0.37% 4.90% 2.15%
Total Consenting Patients Hospital Mortality Operative Mortality at 30 days Operative Mortality at 90 days 86,247 43 76 96 100% 0.05% 0.09% 0.11% DeMaria, EJ. Baseline data from ASMBS-designated bariatric surgery centers of excellence using the Bariatric Outcomes Longitudinal Database. Paper presented at: 26 th Annual Meeting of the American Society for Metabolic and Bariatric Surgery; June 24, 2009; Grapevine, TX.
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Mortality rates following common operations in U.S. hospitals
Aortic Aneur CABG Craniot Esophag Resect Hip Replac Panc
1036 1600 1717 3445 1302
Ped.
Heart Surgery
458
Number of Hospitals performing operation
National Average Mortality rate( %) 2485 3.9
Average Hospital ] caseloads Median
30 3.5
491 10.7
12 9.1
5 0.3
24 8.3
8 5.4
4 [i] Dimick JB, Welch HG, Birkmeyer JD. Surgical mortality as an indicator of hospital quality. JAMA 2004,292, 847-851
SRC: Bariatric Surgery Mortality 0.3% (55,567 patients) 106 Hospitals reporting Average Case Load: 312 cases/year
cases 30 day mortality
colon
5060 2.53%
esophagus
628 5.73%
liver
698 3.15%
pancreas
459 3.59%
lung
3973 2.35%
2006: Medicare and Medicaid granted National Coverage Determination (NCD) SRC (and ACS) named a CMS Certifying agency Favorable coding changes Carriers are listening and negotiating SRC asked to manage some carriers’ COE programs Improved access, improved care
SRC is vigilant and responds Carriers constantly try other approaches to limit access Benefit packages, co-pays, etc.
Responding with Education Patients Public Colleagues
To care for our patients To improve our care To negotiate fair contracts To preserve our profession We need reliable information The Surgical Review Corporation is meeting that challenge
Data = Power
The Gold Standard
The first organized effort by a professional society to improve care through cooperation with colleagues, hospitals, the government and industry stakeholders A Centers of Excellence effort based on outcomes verified by site inspections BOLD: A software program that is affordable, includes widely agreed upon definitions, allows measurable population data analysis and, most important, avoids free text entries Clear documentation that the effort now delivers bariatric surgical care to the US, in spite of the severe risks characteristic of these patients, with the safety of cholecystectomies Data owned by surgeons, available to surgeons in their negotiations with payers, malpractice carriers ---finally providing a basis for fair negotiation The framework for future, consortium, prospective controlled studies in real time. The admiration of industry, the government and the payers.
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SRC Statistics
Total Applicants
:
Centers of Excellence
: 1,110 Hospitals 1,922 Surgeons 405 Hospitals 697 Surgeons
ICE Centers located in United Kingdom, Taiwan and Brazil
BOLD Database:
210,050+ Patients Entered
Over
12,000 new patients entered each month
969 surgeons and 724 facilities using
BOLD
Patients Complications Re-operations Readmissions 30-day mortality
Before BSCOE 2003 – Nov. 2005
1,582 11.1% 5.7% 9.8% 0.56%
After BSCOE Nov. 2005 - 2008
2,445 3.1% 1.1% 3.1% 0.0% 48
Guidelines of Institutions Granting Bariartic Privileges Utilizing Laparoscopic techniques SAGES 07/2009
Formal residency in General Surgery part of a team that is dedicated to long term follow up Documented training of bariatric cases Completion of a formal course Experience with a preceptor Results must be monitored
Residency Most residents will not be adequately trained by the end of their residency 1-2 day weekend courses Mini-fellowships Onsite mentoring Remote telementoring Telesimulation Formal MIS fellowship training for 1-2 years
Program in development at Toronto Western Hospital Pilot program: Telesimulation training in SAGES FLS program VR Telesimulation On site mentorship during live cases Remote mentoring of live cases Distributed over 6-12 months
Humber River Regional Hospital experience Development of Centers of Excellence in USA Surgical Review Corporation Surgical training