Real World Effectiveness of Implantable Cardioverter Defibrillators in Medicare Patients

On September 21, 2011, Soko Setoguchi made this presentation at the 2011 Annual Conference. Select to access the PowerPoint® presentation (2.3 MB). Plugin Software Help.

Slide 1

Real World Effectiveness of Implantable Cardioverter Defibrillators in Medicare Patients

Soko Setoguchi, MD, DrPH
Duke Clinical Research Institute, Durham, NC

Project Contract Site
Brigham and Women Hospital, Boston, MA

Slide 2

Disclosure

• Conflicts of interest: None.
• Sources of funding: Contract No.HHSA290-2005-0016-I�TO8 from the AHRQ as part of the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) program and Contract 500-2010-00001I TO6 and Contract 500-2010-00001I TO2 from the CMS.
• Dr. Setoguchi is supported by a mid-career development award grant K02-HS017731 from AHRQ.
• The presenter is responsible for the content. Statements in the presentation should not be construed as endorsement by the AHRQ, CMS or the US Department of Health and Human Services.

Slide 3

Ongoing DEcIDE Task Order

• Title: Analysis of Data Associated with CMS Coverage with Evidence Development Initiatives:
  • Real World Effectiveness of Carotid Artery Stenting and Implantable Cardioverter Defibrillators in Medicare Patients.
• Fund: interagency contract between AHRQ and CMS.
• Contract site: Brigham and Women's Hospital DEcIDE Center.

Slide 4

Outline

• Introduction and current status of our CMS ICD project.
• Presentation of results from a recently completed ICD study.

Slide 5

Implantable Cardioverter Defibrillators (ICDs)

Slide 6

ICDs in Real World

• Real world patients receiving ICDs:
  • Median age: 74 yrs.
  • Non-cardiac comorbidities are common:
    • 36% Diabetes.
    • 22% Chronic lung disease.
  • Insurance Type:
    • 77% CMS
      • American College of Cardiology National Cardiovascular Data Registry (ACC NCDR) Report.
  • Benefit of ICD is not established in:
    • Elderly patients.
    • Those with comorbidities.
    • Real world practice setting.

Slide 7

ICD Study: Aims

• Aim 1: To demonstrate differences in the incidence rate of death and cardiovascular hospitalizations between trial populations and Medicare patients undergoing ICD implantation.
• Aim 2: To explore the incidence of death and cardiovascular hospitalizations in subgroups of patients undergoing ICD implantation by gender, age category, and comorbidities.
• Aim 3: To identify subgroups of patients undergoing ICD implantation for whom 1) ICDs are not effective (expected survival < 18 months) and 2) ICDs are not cost-effective (expected survival < 5 years).
• Aim 4: To estimate the incidence of various potential short and long-term adverse events following ICD implantation.
• Aim 5: a) To directly compare ICD vs. medical management and b) to assess the impact of unmeasured confounding in a well-designed comparative effectiveness study.

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Key Features of the DEcIDE CMS ICD Study

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Bringing In Multiple Players

Slide 10

Core Investigator Team

BWH DEcIDE Center Core Team:

• Soko Setoguchi Iwata, MD DrPH (PI, BWH/Duke).
• John Seeger, PharmD, DrPH (Site PI).
• Natasha (Chih-Ying ) Chen, PhD (Research Fellow).
• Lauren Williams, BA (Research Assistant).
• Helen Mogun, MS and Jun Liu, MD MPH (Programmers).

Clinical Experts:

• Lynne Warner Stevenson, MD (Co-Investigator).
• Garrick Stewart, MD, MPH (Co-Investigator).

Method Experts:

• Sebastian Schneeweiss, MD ScD (BWH DEcIDE PI).
• Robert Glynn, PhD ScD (Co-investigator).

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Contracting/Supporting Groups/Individuals

• Outcome Sciences Inc.:
  • Providing the national clinical registries for HF and myocardial infarction (MI).
  • Nancy Dreyer, PhD.
• ACC NCDR:
  • Supplementing CMS ICD Registry with data from ACC NCDR ICD Registry.
• Center for Outcomes Research and Evaluation (CORE), Yale-New Haven Hospital:
  • Bridging BWH DEcIDE Center and ACC NCDR.
  • Collaborating on the ICD complication aim.
• Brown University:
  • Melissa Clark, PhD, Brown University for the supplemental survey study.
• Univ. of British Columbia:
  • Winson Cheung, MD MSc for the supplemental survey study.

Slide 12

TEP members

• Jeptha Curtis, MD (Yale School of Medicine & Yale-New Haven Hospital, New Haven, CT).
• Sherri Dodd, MS (Medtronic Inc, Minneapolis, MN).
• Kenneth Ellenbogen, MD (Virginia Commonwealth University Pauley Heart Center, Richmond, VA).
• Marcel E. Salive, MD, MPH (National Institute on Aging at National Institutes of Health, Bethesda, MD).
• Lynett Voshage Stahl (Boston Scientific Corporation, Arden Hills, MN).

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Putting Multiple Data Sources Together

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Brigham DEcIDE Center

Image of a large flowchart.

1) Dataset of entire study cohort (65+) and linkage information* (HF/MI registry)
2) A portion of the NCDR ICD registry including identifiers, reason for admission, prior heart failure hospitalization, QRS duration, Creatinine, B-type natriuretic peptide, and systolic blood pressure (ACC-NCDR registry).
3) CMS ICD registry with identifiers.
4) ACC-NCDR variables added to CMS ICD registry.
5) CMS sends Medicare files (100% Denominator & MedPAR) to BWH DEcIDE Center.
6) BWH DEcIDE Center receives Medicare Files (Stage 1).
7) Partial linkage information: SSN.
8) CMS receives partial linkage information (Stage 2)
9) Extract Medicare Part A, B, and D files using partial linkage information
10) BWH DEcIDE Center receives Medicare Files (Stage 2)
11) Creation of Research Database using Medicare files and linkage information

* HF/MI Registry: Clinical Registry from Outcome DEcIDE Center for heart failure and myocardial infarction.

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Multiple Studies are Underway to Inform.....

• Long-term outcomes (benefit and complications) after ICD implantation.
• Who benefit or don't benefit from ICDs.
• Methodological challenges and potential solutions in assessing effectiveness of ICDs using large databases.
• Clinical effectiveness of ICDs and magnitude of potential bias in observational studies
  ........in Medicare patients.

Slide 16

Survival after ICD Implantation in Medicare Patients with Heavy Burden of Heart Failure

Natasha Chen, Lynne Warner Stevenson, John D Seeger, Lauren Williams, Jessica J Jalbert, Andrew Rothman, Garrick C Stewart, Soko Setoguchi

Slide 17

Background and Purposes

• Little is known about long-term survival after primary ICD implantation in Medicare patients:
  • Especially in those with heavy burden of HF and other comorbidities.
• To describe survival following primary ICD implantation and assess the impact of the burden of HF on survival.

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Data Sources

• Centers for Medicare & Medicaid Services ICD registry.
• Medicare Provider Analysis and Review (MedPAR):
  • Years 2005–2008.
  • Linked by a previously described method using multiple non-unique identifiers:
    • Date of birth, date of admission, gender, hospital ID.

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Study Design

Image of a flowchart.

Step 1. Recipients in CMS-ICD registry+
MedPAR files (Year 2005-2008)

Step 2. Recipients met indications for primary ICD
-EF = 35%
-No cardiac arrest/sustained VT

Recipients of prophylactic ICD
≥ 1yr eligibility
- Age ≥ 66 yrs

Index time: 1st ICD implantation

Outcomes: All-cause mortality

Censoring: ICD removal
Loss of eligibility
12/31/2008

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HF Burden and Analysis

• Chronic burden of HF:
  • Number of HF hospitalizations in the previous year.
• Acute burden of HF:
  • Days from admission to implant during HF/ICD hospitalization.
• Kaplan-Meier survival estimates for crude mortality.
• Cox proportional hazard regression models for adjusted hazard ratios (HRs).

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Characteristics for Medicare ICD Patients (N=66,974)

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Outcomes in Overall Medicare Primary ICD Patients (N=66,974)

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Mortality after ICD Implant (N=66,974)

Image: A graph showing the 3 year mortality is shown.

Medicare ICD Patients 31%
SCD HeFT 16%
MADIT II 22%

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Characteristics by Number of Hospitalizations

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Mortality by # of HF Hospitalizations in the Past Year

Image: Graph of mortality by # of HF hospitalizations in the past year is shown.

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Risk of Mortality in Patients with ≥1 HF Hospitalizations During 1 Year Prior to Implant vs. Those with No Prior Hospitalizations in the Past Year

Slide 27

Characteristics by Number of Days from Admission to Implantation

Slide 28

Mortality by # Days from Admission to Procedure

Image: Graph of mortality by number of days from admission to procedure is shown.

Slide 29

Risk of Mortality in Patients with ≥1 Days Prior to Implant vs. Those with Implant on Admission Day

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Conclusion

• In 3 years, nearly one third of patients receiving a primary ICD implantation were died in this Medicare population.
• 3-year Mortality increased to 1/2 among patients with at least 2 HF hospitalizations or 7 days between admission and implantation.

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Implications

• Indications and potential benefits should be carefully weighed when considering primary ICD implantation for Medicare patients with greater HF burden.

Slide 32

Acknowledgement

Agency for Healthcare Research and Quality

• Elise Berliner, PhD

Centers for Medicare and Medicaid

• Rosemarie Hakim, PhD

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Blank slide

Slide 34

Image of a flowchart.

• 216,884 ICD implantations in those aged >= 65 yrs between 2005 and 2008
  • Excluded
    26,106 (12%) records with incomplete information on linkage variables: admission dates, provider ID, date of birth, and gender.
• 190,778 records with complete linkage variables
• 122,562 ICD records linked to MedPAR records
  • Excluded
    4,032 with missing EF
    4,498 with EF > 35%
    24,227 with repeated ICD
    27,810 for secondary prevention
    14,739 with prior cardiac arrest
    17,158 with history of sustained VT
    5,725 with < 1 yr continuous eligibility
    5,248 with age < 66 years old
    2,045 with no device type information.
• 66,974 patients eligible

Slide 35

Implantable Cardioverter Defibrillator (ICD)

• Ventricular arrhythmia is common among heart failure (HF) patients:
  • 50-80% non-sustained ventricular tachycardia (VT).
  • 5% sustained VT or ventricular fibrillation (VF) (fatal).
• Presence of HF increases the sudden death rate 5.5-fold in both men and women (Framingham heart study).

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Implantable Cardioverter Defibrillator (ICD)

• ICDs have shown to be beneficial as a primary prevention of sudden cardiac death (SCD) among HF patients with systolic dysfunction in trials (primary prevention of SCD).
• National Coverage Decision (NCD) in Jan 2005:
  • CMS expanded the coverage for ICD implantation for primary prevention.

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Important Covariates

Identify from registry:

• Age at index date
  (66-70, 71-75, 76-80, 81-85, 85+ yrs).
• Gender.
• HF duration (0/0-3/3-9 mo).
• Ejection fraction (<30, 30-35%).
• NYHA class (I, II, III, IV).
• QRS interval (<120, =120 msec).
• Device type (Single/dual chamber).
• Estimated GFR
  (<15, 15-29, 30-59, 60-89, >90 mL/min/1.73m²).
• BNP(<130, 131-230, 231-480, >480 pg/mL).
• SBP (<80, 80-100, 101-130, 131-150, >150mmHg).
• Sodium (<135, 135-145, >145 mEq/L).
• Elective/non-elective procedure.

Identify from CMS files:

• Race (Whites/Blacks/Hispanics/others).
• Diabetes (Y/N) Chronic kidney disease (Y/N).
• Atrial fibrillation (Y/N) Beta-blocker use* (Y/N).
• ACEI/ARB use* (Y/N).
• Aldosterone receptor antagonists use* (Y/N).

Identify from registry and CMS files:

• Prior HF hospitalizations (0, 1, 2, 3, 4, ≥5).
• HF cause (Ischemic/non-ischemic).

Slide 38

Outcome Definitions

Slide 39

Characteristics by Number of Hospitalization.

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Current as of December 2011

Internet Citation:

Real World Effectiveness of Implantable Cardioverter Defibrillators in Medicare Patients. Slide Presentation from the AHRQ 2011 Annual Conference (Text Version). December 2011. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/about/annualconf11/greenlee_masoudi_sanders_setoguchi/setoguchi.htm