Real World Effectiveness of Implantable Cardioverter Defibrillators in Medicare Patients

Slide Presentation from the AHRQ 2011 Annual Conference

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

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

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

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

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)

Implantable Cardioverter Defibrillators (ICDs)

Slide 6

ICDs in Real World

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

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.

Slide 8

Key Features of the DEcIDE: CMS ICD Study

Key Features of the DEcIDE CMS ICD Study

Slide 9

Bringing In Multiple Players  

Bringing In Multiple Players

Slide 10

 Core Investigator Team

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).

Slide 11

 Contracting/Supporting Groups/Individuals

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

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).

Slide 13

 Putting Multiple Data Sources Together

Putting Multiple Data Sources Together

Slide 14

 Brigham DEcIDE Center

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.

Slide 15

 Multiple Studies are Underway to Inform . . .

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  

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

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.

Slide 18

Data Sources  

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.

Slide 19

 Study Design

Study Design

Image of a flowchart.

Index time: 1st ICD implantation

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

Outcomes: All-cause mortality

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

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

Step 3: Recipients in CMS-ICD registry+

MedPAR files (Year 2005-2008)

Slide 20

 HF Burden and Analysis

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).

Slide 21

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

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

Characteristic%
Median Age (IQR)
Male
White
75 yrs (71-80)
73%
88%
Median EF (IQR)25% (20-30)
HF Duration
    New HF
    0-3 months
    3-9 months
    >9 months
12%
14%
13%
61%
NYHA class
    I
    II
    III
    IV
6%
31%
58%
5%
Ischemic HF79%

Slide 22

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

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

OutcomeN
Death (N)
 
11,876
In-hospital death (N)327
In-hospital death risk (95% CI)0.49% (0.45-0.55)
Average follow-up (range1.4 years (0-4)
Mortality risk (95% CI)
   1-year
   2-year
   3-year   
12% (12-13)
22% (22-23)
31% (30-32)

Slide 23

Mortality after ICD Implant (N=66,974)  

Mortality after ICD Implant (N=66,974)

Image: A line graph showing the 3-year mortality for ICD implant patients.

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

Slide 24

 Characteristics by Number of Hospitalizations

Characteristics by Number of Hospitalizations

CharacteristicNumber of Hospitalizations
# of Prior HF Hosp0
N=52,963
1
N=10,247
2
N=2,501
≥3
N=1,263
N (% total population)79%15%4%1%
Age (IQR)
Male
White
75 (71-80)
75%
89%
76 (71-80)
67%
85%
76 (71-81)
63%
79%
76 (71-80)
60%
74%
EF(%) (IQR)
   ≤20%
25 (20-30)
31%
25 (20-30)
43%
25 (20-30)
43%
23 (20-30)
48%
HF Duration
    >9 months

59%

66%

69%

74%
NYHA class
   I
   II
   III
   IV
7%
33%
56%
4%
2%
23%
67%
7%
2%
19%
69%
10%
1%
15%
70%
16%

Slide 25

 Mortality by # of HF Hospitalizations in the Past Year

Mortality by # of HF Hospitalizations in the Past Year

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

Slide 26

 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

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

Risk of Mortality% (N)
# of prior HF hosp in the past year0 hosp
N=52,963
1 hosp
N=10,247
2 hosp
N=2,501
≥3 hosp
N=1,263
Mortality
  1-yr mortality
  2-yr mortality
  3-yr mortality

10% (10-11)
19% (19-20)
27% (27-28)

17% (16-18)
30% (29-31)
40% (38-43)

24% (23-26)
37% (35-40)
52% (46-57)

33% (30-36)
51% (48-55)
63% (57-68)
Hazard ratio(HR)
  Unadjusted
  Age, sex, race adjusted

-
-

1.7 (1.6-1.7)
1.6 (1.6-1.7)

2.2 (2.1-2.4)
2.2 (2.0-2.3)

3.4 (3.2-3.8)
3.3 (3.0-3.6)

Slide 27

Characteristics by Number of Days from Admission to Implantation  

Characteristics by Number of Days from Admission to Implantation

CharacteristicsNumber (%)
# of days from adm to implant0 days
N=39,576
1 day
N=5,636
2-7 days
N=16,959
8-14 days
N=4,803
% total population59%8%25%7%
Age, median (IQR)
    Age ≥ 80y
 
75 (70-80)
25%
 
76(71-80)
28%
 
76 (71-81)
30%
 
76 (71-81)
30%
 
Male74%76%71%71%
White91%89%84%81%
EF ≤ 20%30%36%40%45%
HF Duration
   New HF
   0-3 months
   >3 months

13%
10%
77%

13%
14%
73%

11%
20%
69%

8%
26%
66%
NYHA class
   I
   II
   III
   IV

6%
34%
57%
3%

6%
30%
59%
5%

5%
26%
60%
9%

3%
22%
62%
13%

Slide 28

Mortality by # Days from Admission to Procedure

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

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

Risk of Mortality% (N)
# days from admission to procedure0 days
N=39,576
1 day
N=5,636
2-7 days
N=16,959
8-14 days
N=4,803
Mortality
  1-yr mortality
  2-yr mortality
  3-yr mortality

8% (8-8)
16% (16-17)
25% (24-25)

12% (11-13)
22% (21-23)
32% (29-35)

18% (18-19)
30% (29-31)
41% (39-42)

29% (28-31)
43% (41-44)
53% (50-57)
Hazard ratio (HR)
  Unadjusted
  Age, sex, race adjusted

-
-

1.4 (1.3-1.5)
1.4 (1.3-1.5)

2.1 (2.0-2.2)
2.0 (1.9-2.1)

3.4 (3.2-3.6)
3.2 (3.1-3.4)


Slide 30

 Conclusion

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.

Slide 31

Implications  

Implications

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

Slide 32

 Acknowledgement

Acknowledgement

Agency for Healthcare Research and Quality

  • Elise Berliner, PhD

Centers for Medicare and Medicaid

  • Rosemarie Hakim, PhD

Slide 33

Blank slide

Slide 34

Flow Chart  

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)

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).

Slide 36

 Implantable Cardioverter Defibrillator (ICD)

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.

Slide 37

 Important Covariates

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

Outcome Definitions

OutcomesDefinitions
DeathDeath identified from CMS Vital status file
All-cause Hospitalization1st hospitalization (identified from Part A file) after the discharge date of ICD implantation, not counting visit for ICD evaluation
HF1st hospitalization with ICD-9-CM code (Dx) 428.xx as the primary discharge diagnosis
MI1st hospitalization with Dx 410.xx as the primary discharge diagnosis and with length of stay > 3 days (unless patients died) and < 180 days.
Cardiac events1st hospitalization with the following codes as the primary discharge diagnosis: 428.xx, 410.xx
413.x (Angina pectoris) 420.0, 420.9x (Acute pericarditis)
421.x (Acute and sub-acute endocarditis)
423.x (Other disease of pericardium)
424.2 (Tricuspid valve disorders specified as nonrhumatic
426.x (Conduction disorder) 427.xx(Cardiac dysrythmia)

Slide 39

Characteristics by Number of Hospitalization  

Characteristics by Number of Hospitalization

 0123
QRS ≥ 120 msec32,949 (62)6,817 (67)1,651 (66)852 (67)
Ischemic cause HF42,168 (80)7,995 (78)2,020 (81)1,049 (83)
Unsustained VT12,382 (23)2,273 (22)590 (24)309 (24)
Mean prior Hospitalization
   for any cause
    ≥ 5

0.6 (1)
506 (1)

2 (1.3)
498 (5)

3.2 (1.4)
402 (16)

5.5 (2.6)
983 (41)
Mean LOS of implantation
Admission to implantation
3.9 (5.2)
1.9 (3.6)
4.2 (5.5)
2 (3.5)
5 (6)
2.5 (4.4)
5.9 (6.2)
3.0 (4.2)
Mean Charlson Score not counting cardiac conditions0.6 (1.2)1.8 (1.6)2.5 (1.7)3.1 (1.8)

Slide 40

Chart  

 0 days1 day2-7 days8-14 days
QRS ≥120 msec25,363 (64)3,752 (67)10,365 (61)2,789 (58)
Ischemic cause HF31,111 (79)4,452 (79)13,662 (81)4,007 (83)
Unsustained VT6,384 (16)1,436 (26)5,578 (33)2,156 (45)
Mean prior Hospitalization for any cause
    ≥ 5
0.9 (1.3)
919 (2)
1.1 (1.5)
202 (4)
1.1 (1.6)
738 (4)
1.4 (1.8)
267 (6)
Mean LOS of implantation
Implantation to discharge
1.4 (1.7)
1.4 (1.7)
3.1 (2.7)
2.1 (2.7)
6.9 (3.7)
2.8 (3.2)
16.4 (5.7)
4.4 (5)
Mean Charlson Score not counting cardiac conditions0.8 (1.3)1 (1.4)1.1 (1.6)1.3 (1.7)
Page last reviewed March 2012
Internet Citation: Real World Effectiveness of Implantable Cardioverter Defibrillators in Medicare Patients. March 2012. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/events/conference/2011/setoguchi/index.html