john hagen md frcs(c) assistant professor surgery university of toronto
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John Hagen MD FRCS(C)Assistant Professor SurgeryUniversity of Toronto
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Honorarium- CovidienHonorarium-Ethicon
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Humber River Regional Hospital experience
Development of Centers of Excellence in USA
Surgical Review CorporationSurgical training
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Community hospital in the north of Toronto
Bariatric surgery program began in 1999Laparoscopic bariatric surgery began 2004Over 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
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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
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Poor selection of patientsMedical conditions not optimized
prior to surgeryLack of integration between
anaesthesia, internal medicine, surgery and bariatric clinic
Inadequate post-op monitoringDiagnostic laparoscopy when
problems occur not utilized enough
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The program is up and runningApplication to become “ACS Center
of Excellence” has been madeHiring of nurse practioners Integration of the bariatric clinic with
specialists and staffWhat began as an “interest in
laparoscopy” has been transformed into a program
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Poor outcomes will not be tolerated
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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
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Bariatric surgery could be performed with few complications
NIH recognized the effectiveness of bariatric surgery in its Consensus Statement of 1991
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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
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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
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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”
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Establishment of Centers of Excellence
Standards for training and resourcesThe need to recognize the centers
that perform well
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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
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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
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Walter J. Pories, MD, FACSChairman of the BoardSurgical Review Corporation
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20th Century E=mc2
21st Century Data = Power
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1950 – 2000: Development of Bariatric
and Metabolic Surgery. Durable control of obesity with
reduction of mortalityFull, durable remission of diabetes
and other co-morbidities independent of weight loss
With remarkable safety
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Mean Weight Mean % XS Weight Loss
Mean BMI
Preop 317 0 51
1 year 199 67 32
2 years 194 69 32
5 years 209 57 34
10 years 217 51 35
16 years 211 55 37 21155
106 lb
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608 morbidly obese
146 Type 2Diabetics
152 IGT“impaired”
121/146 (83%)euglycemic
150/152 (99%)euglycemic
And Durable, Full Remission of Type 2 Diabetes Independent of Weight Loss
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Enthusiastic gratitude for the conquest of obesity and diabetes?
No
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Carriers: Who will pay for this?Colleagues: can’t be trueVariable outcomes in USPress reports of complications Increased litigationUnaffordable malpractice
premiumsLoss of access
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Could not deny the advancesCarriers develop Centers of
Excellence Programs Multiple Standards Multiple Applications Inadequate databases Arbitrary Decisions No sharing of data
Patients denied; surgeons hassled
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It’s up to us…..How shall we proceed?
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To win:Must be able to document our results
But we do not have the information Selected data were from major
centersOvercome variable levels of care in
U.S.Without information
We cannot improve We cannot defend
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CredibleUsefulClinically reasonableEconomicEthical/Confidential
The Process Must Be
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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
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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)
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A separate, non-profit, transparent organization Policy: Board of Directors with
stakeholders on the Board Surgical Decisions: A Review Committee of
experienced, respected surgeonsCorporate Structure to manage the
complex programs Nov. 2003: THE SURGICAL REVIEW CORPORATION
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Clinical Quality and ComplianceStrategic AlliancesOperationsResearch
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Total applicants 719 Hospitals, 1,235 SurgeonsCenters of Excellence 233 Hospitals 458 SurgeonsApplicant Patient Data Base 108,200+ patients Cost $8.75
per patient
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Total # of patients 61,545 100%
Hospital Mortality 83 0.14%
Operative Mortality at 30 days (83 + 98 = 181)
191 0.29%
Operative Mortality at 90 days ( 83+98+44= )
225 0.37%
Re-admissions 3,018 4.90%
Re-operations 1,325 2.15%
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Total Consenting Patients 86,247 100%
Hospital Mortality 43 0.05%
Operative Mortality at 30 days
76 0.09%
Operative Mortality at 90 days
96 0.11%
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DeMaria, EJ. Baseline data from ASMBS-designated bariatric surgery centers of excellence using the Bariatric Outcomes Longitudinal Database. Paper presented at: 26th 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
AorticAneur
CABG Craniot EsophagResect
HipReplac
Panc Ped.Heart Surgery
Number of Hospitals performing operation
2485 1036 1600 1717 3445 1302 458
National AverageMortality rate( %)
3.9 3.5 10.7 9.1 0.3 8.3 5.4
Average Hospital caseloads Median
30 491 12 5 24 8 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
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colon esophagus
liver pancreas lung
cases 5060 628 698 459 3973
30 day mortality
2.53% 5.73% 3.15% 3.59% 2.35%
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2006: Medicare and Medicaid granted National Coverage Determination (NCD)
SRC (and ACS) named a CMS Certifying agency
Favorable coding changesCarriers are listening and negotiatingSRC asked to manage some carriers’
COE programs Improved access, improved care
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SRC is vigilant and responds Carriers constantly try other
approaches to limit access Benefit packages, co-pays, etc.
Responding with Education Patients Public Colleagues
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To care for our patientsTo improve our careTo negotiate fair contractsTo preserve our professionWe need reliable informationThe Surgical Review Corporation is
meeting that challenge
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Data = Power
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The Gold Standard
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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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Total Applicants: 1,110 Hospitals1,922 Surgeons
Centers of Excellence: 405 Hospitals 697 Surgeons
ICE Centers located in United Kingdom, Taiwan and Brazil
BOLD Database: 210,050+ Patients EnteredOver 12,000 new patients entered each month
969 surgeons and 724 facilities using BOLD
SRC Statistics
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Before BSCOE 2003 – Nov. 2005
After BSCOENov. 2005 -
2008
Patients 1,582 2,445Complications
11.1% 3.1%
Re-operations
5.7% 1.1%
Readmissions
9.8% 3.1%
30-day mortality
0.56% 0.0%
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Guidelines of Institutions Granting Bariartic Privileges Utilizing Laparoscopic techniques
SAGES 07/2009
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Formal residency in General Surgerypart of a team that is dedicated to
long term follow upDocumented training of bariatric
casesCompletion of a formal courseExperience with a preceptorResults must be monitored
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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
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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
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Humber River Regional Hospital experience
Development of Centers of Excellence in USA
Surgical Review CorporationSurgical training