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Updates from the Longitudinal Assessment of Bariatric Surgery Minimally Invasive Surgery Symposium February 27 th 2010. Bariatric surgery in evolution-1990s-2002 3,328 gastric bypass 1.9% 30-day mortality High variability at different centers Experience highly associated to outcome.

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slide1

Updates from the Longitudinal Assessment of Bariatric SurgeryMinimally Invasive Surgery SymposiumFebruary 27th 2010

slide2

Bariatric surgery in evolution-1990s-2002

  • 3,328 gastric bypass
  • 1.9% 30-day mortality
  • High variability at different centers
  • Experience highly associatedto outcome
bariatric surgery utilization and outcomes in 1998 and 2004
Bariatric Surgery Utilization and Outcomes in 1998 and 2004

Zhao. AHRQ Statistical Brief, Jan 2007

35

bariatric surgery insurance claims
Bariatric Surgery: Insurance Claims

Encinosa WE, et al. Med Care. 2009 May;47(5):531-5.

motivation for labs
Motivation for LABS
  • Epidemic of obesity
    • Recognition that non-operative approaches were futile
  • Safety concerns were real
  • Process of care related to better outcomes were unclear
  • Mechanism of effect was in doubt
  • Durability unclear
  • Long term outcomes uncertain
methodological options
Methodological Options
  • Large RCT
    • What question would we study?
    • Who would pay for the surgery?
    • Is there equipoise?
  • Prospective cohort
    • Framingham-like study
      • Credibility gap
      • Explore hypotheses
      • Look at associations
    • Lacks a comparison group
      • How would you construct this
      • Who would pay for this
      • Is it a good investment
what is labs
What is LABS?
  • First large-scale NIH study on bariatrics
    • Approved for 5 yrs
    • Recently re-approved

~$20 million to date

  • Timeline
    • 1991 NIH Consensus Conference
    • May 2002 - NIDDK Working Group
    • November 2002 - RFA released
    • September 30, 2003 - LABS funded
    • January 2005 - First patient recruited
    • 2009-Renewed for 5 years
slide8

UWashington/

VMason

NRI/UND

OHSU/

Legacy

Sacramento

Bariatric

GSPH

Columbia/

Cornell

UPMC

NIDDK/

ORWH

ECU

Clinical Center

Clinical Center

Data Coordinating Center

NIDDK / ORWH

what is labs1
What is LABS?
  • Goals
    • Address fundamental issues of safety, mechanism, efficacy and system impact
  • Structure
    • LABS 1
      • Safety
    • LABS 2
      • Impact
    • LABS 3
      • Mechanism
labs 1 personnel
LABS 1: Personnel
  • 33 surgeons
    • 70 coordinators
  • Data Coordinating Center
    • Scientists
    • Analysts
    • Administrators
  • NIDDK scientists
labs 1 nejm
LABS 1: NEJM
  • Prospective clinical database
  • Adequate power
  • Contemporary
  • Rigor of data collection, analysis, and reporting
labs 1 methodology
LABS 1: Methodology
  • LABS Certification

- Surgeons

- Research Coordinators

  • Data Collection and Entry
    • Paper forms
    • Entry online to DCC
    • Double entry
    • Alerts for missing or unusual data
    • Data Audits
  • Data analysis: DCC
  • Manuscript preparation: writing group
  • Final approval: Steering Committee
labs 1 data collection
LABS 1: Data Collection
  • Descriptive data
  • Comorbidities, severity
  • Details of operation
  • Outcome day 30
  • 2005-2008
labs 1 primary outcome
LABS 1: Primary Outcome
  • Composite end point day 30
    • Death
    • DVT/PE
    • Re-intervention
      • Percutaneous, endoscopic or operative
    • Failure to discharge
labs 1 statistical analysis
LABS 1: Statistical Analysis
  • Descriptive statistics
  • Correlations examined
  • Adjustment for main effects
labs 1 outcomes
LABS 1: Outcomes

Associations with Adverse Outcome After Adjustment

  • Extremes of BMI
  • Inability to walk 200 feet
  • History of DVT/PE
  • History of Obstructive Sleep Apnea
  • Gastric bypass vs. LAGB
labs 1 outcomes1
LABS 1: Outcomes

Adverse Outcome

  • Laparoscopic gastric bypass 4.8x LAGB
  • Unexpected finding-lowest risk at BMI 53
labs 1 outcomes2
LABS 1: Outcomes

Not Associated with Adverse Outcome

  • Age, gender
  • Diabetes, hypertension
  • Heart disease
slide28

Predicted Probabilities of Adverse Outcomes, According to a History of Deep-Vein Thrombosis or Venous Thromboembolism (DVT) or Obstructive Sleep Apnea (OSA)

why bariatric surgery safety improved
Why Bariatric Surgery Safety Improved
  • Improved techniques
    • Laparoscopy
    • Gastric trans-section
    • Gastric banding
    • Improved technology/skills
  • Broadening of lower-risk patient pool
  • Accreditation process
    • Volume and expertise-based
      • Surgical Review Corporation
      • American College of Surgeons
rationale for volume based referral
Rationale for Volume-based Referral
  • High risk population
  • Technically difficult procedure
  • Increased financial incentive to adopt
  • Limited training programs
  • Clinical confusion about optimal approach
  • No regulation or surveillance
  • Volume-based referral has been effective for similar conditions
slide36

Bariatric surgery in evolution-1990s-2002

  • 3,328 gastric bypass
  • 1.9% 30-day mortality
  • High variability at different centers
  • Experience highly associatedto outcome
slide39

MEDICARE EXPANDS COVERAGE FOR LIFESAVING OBESITY SURGERY

Private Insurers Expected to Follow Suit 

GAINESVILLE, FL – Feb. 21, 2006 -- After an extensive review of medical evidence that lasted nearly a year, the Centers for Medicare & Medicaid Services (CMS) announced today it will establish a national coverage policy for bariatric surgery to help reduce the significant health risks, including death and disability, associated with obesity.   This new policy will apply to all Medicare recipients including those over 65 and Medicare disabled who are morbidly obese (body mass index or BMI of 35 or greater) with any obesity related condition or disease and have been previously unsuccessful with the medical treatment of obesity.

number of bariatric procedures by quarter from 10 01 2004 through 06 30 2008
Number of bariatric procedures by quarter from 10/01/2004 through 06/30/2008

Nguyen, Archives of Surgery Jan. 2010

labs volume outcome data
LABS Volume-Outcome Data
  • 3410 RYGB procedures
    • Laparoscopic 87.2%
    • Median age 44 years
    • Median BMI 47.2 kg/m2
    • Women 80.2%
    • At least 2 co-morbidities 56.2%
  • 31 RYGB surgeons
    • 1 – 49 RYGB cases/year 15 surgeons
    • 50+ RYGB cases/year 16 surgeons
results
Results
  • RYGB annual case volume inversely associated with risk of adverse outcomes
  • Continuous relationship without clear breakpoints
  • For each 10 cases per year increased volume, risk of adverse outcome decreased 10%
volume outcome conundrum
Volume:Outcome Conundrum
  • Volume based referrals may very well save lives BUT
  • Volume is a surrogate for process of care
    • Process of care is hard to study
  • Volume is often a surrogate for case-mix
    • Case mix is hard to study
  • It is unclear what would happen if high volume hospitals suddenly received patients with the same case mix of low volume hospitals
  • Biggest argument against volume based referral is access to care
    • Physician vs patient concern
summary
Summary
  • Volume:Outcome for bariatric surgery is real
    • AND it’s problematic
  • Volume is likely a surrogate for process of care
    • AND very few are working on understanding this
  • Volume-based referrals has already and will probably continue to save lives
    • AND it’s a “too easy” policy intervention
  • Lower volume surgeons and centers will never like this
    • AND this is self-serving
  • Alternatives to improving the system are also problematic
    • AND critics of volume have not done a great job creating other systems