John Hagen MD FRCS(C)Assistant Professor SurgeryUniversity of Toronto

Honorarium- CovidienHonorarium-Ethicon

Humber River Regional Hospital experience

Development of Centers of Excellence in USA

Surgical Review CorporationSurgical training

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

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 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

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

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

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 resourcesThe 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, FACSChairman of the BoardSurgical Review Corporation

20th Century E=mc2

21st Century Data = Power

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

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

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

Enthusiastic gratitude for the conquest of obesity and diabetes?

No

Carriers: Who will pay for this?Colleagues: can’t be trueVariable outcomes in USPress reports of complications Increased litigationUnaffordable malpractice

premiumsLoss of access

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

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

centersOvercome variable levels of care in

U.S.Without information

We cannot improve We cannot defend

CredibleUsefulClinically reasonableEconomicEthical/Confidential

The Process Must Be

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 surgeonsCorporate Structure to manage the

complex programs Nov. 2003: THE SURGICAL REVIEW CORPORATION

Clinical Quality and ComplianceStrategic AlliancesOperationsResearch

Total applicants 719 Hospitals, 1,235 SurgeonsCenters of Excellence 233 Hospitals 458 SurgeonsApplicant Patient Data Base 108,200+ patients Cost $8.75

per patient

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%

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%

38

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.

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

colon esophagus

liver pancreas lung

cases 5060 628 698 459 3973

30 day mortality

2.53% 5.73% 3.15% 3.59% 2.35%

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

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 patientsTo improve our careTo negotiate fair contractsTo preserve our professionWe need reliable informationThe 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.

47

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

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%

48

Guidelines of Institutions Granting Bariartic Privileges Utilizing Laparoscopic techniques

SAGES 07/2009

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

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 CorporationSurgical training