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.
- 77% CMS
- 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.
Slide 8
Key Features of the DEcIDE CMS ICD Study
Slide 9
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).
Slide 11
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).
Slide 13
Putting Multiple Data Sources Together
Slide 14
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.....
- 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.
Slide 18
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
Image of a flowchart.
Index time: 1st ICD implantation
Step 1. Recipients of prophylactic ICD
≥ 1yr eligibility
- Age ≥ 66 yrs
Outcomes: All-cause mortality
-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
- 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)
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 HF | 79% |
Slide 22
Outcomes in Overall Medicare Primary ICD Patients (N=66,974)
Outcome | N |
---|---|
Death (N) | 11,876 |
In-hospital death (N) | 327 |
In-hospital death risk (95% CI) | 0.49% (0.45-0.55) |
Average follow-up (range | 1.4 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)
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
Characteristic | Number of Hospitalizations | |||
---|---|---|---|---|
# of Prior HF Hosp | 0 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
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 | % (N) | |||
---|---|---|---|---|
# of prior HF hosp in the past year | 0 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 | Number (%) | |||
---|---|---|---|---|
# of days from adm to implant | 0 days N=39,576 | 1 day N=5,636 | 2-7 days N=16,959 | 8-14 days N=4,803 |
% total population | 59% | 8% | 25% | 7% |
Age, median (IQR) Age ≥ 80y | 75 (70-80) 25% | 76(71-80) 28% | 76 (71-81) 30% | 76 (71-81) 30% |
Male | 74% | 76% | 71% | 71% |
White | 91% | 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
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 | % (N) | |||
---|---|---|---|---|
# days from admission to procedure | 0 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
- 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
- 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
Slide 33
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.
- Excluded
- 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.
- Excluded
- 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).
Slide 36
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
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
Outcomes | Definitions |
---|---|
Death | Death identified from CMS Vital status file |
All-cause Hospitalization | 1st hospitalization (identified from Part A file) after the discharge date of ICD implantation, not counting visit for ICD evaluation |
HF | 1st hospitalization with ICD-9-CM code (Dx) 428.xx as the primary discharge diagnosis |
MI | 1st hospitalization with Dx 410.xx as the primary discharge diagnosis and with length of stay > 3 days (unless patients died) and < 180 days. |
Cardiac events | 1st 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
0 | 1 | 2 | 3 | |
---|---|---|---|---|
QRS ≥ 120 msec | 32,949 (62) | 6,817 (67) | 1,651 (66) | 852 (67) |
Ischemic cause HF | 42,168 (80) | 7,995 (78) | 2,020 (81) | 1,049 (83) |
Unsustained VT | 12,382 (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 conditions | 0.6 (1.2) | 1.8 (1.6) | 2.5 (1.7) | 3.1 (1.8) |
Slide 40
0 days | 1 day | 2-7 days | 8-14 days | |
---|---|---|---|---|
QRS ≥120 msec | 25,363 (64) | 3,752 (67) | 10,365 (61) | 2,789 (58) |
Ischemic cause HF | 31,111 (79) | 4,452 (79) | 13,662 (81) | 4,007 (83) |
Unsustained VT | 6,384 (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 conditions | 0.8 (1.3) | 1 (1.4) | 1.1 (1.6) | 1.3 (1.7) |