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Primary Prevention ICDs: Under-,
Over- and Appropriate Usage
Sana M. Al-Khatib, MD, MHS
Associate Professor of Medicine
El...
Potential Conflicts of Interest

■  I receive research funding from the National Heart,

Lung and Blood Institute and from...
Question # 1
■  Which of the following is true:
1)  Studies have shown underutilization of primary

prevention ICDs but no...
Question # 2

■  Is the following statement true or false:
■  Primary prevention ICDs are being overutlized in

the United...
Question # 3

■  Which of the following is true about the ACC’s

AUC criteria:
1)  They were developed to be used for reim...
ICD Therapy Saves Lives!
ICD therapy improves the survival of several
patient populations at an increased risk for sudden
...
Al-Khatib et al. JAMA 2013
Curtis et al. JAMA 2007
Do Men Receive an ICD More Often Than Women?
3.15
2.61
3.73

2.44
2.19
2.66
1.96

Covariates included race, cerebrovascula...
Hernandez et al. JAMA 2007
Adjusted Odds for an ICD*
N=13,034
35% of eligible patients either had an ICD in place or an ICD planned
0.73

Black male
...
Al-Khatib et al. Circulation 2012
ICD Use in HF: Change in Sex and Race
Disparities?
ICD Use in 2005 and 2009 for Each Sex and Race Group.
ICD use in 2005 (...
Kong et al. Am Heart J 2010
Al-Khatib et al. JAMA 2011
Rates of Non–Evidence-Based ICDs Across Sites
22.5% did not meet
evidence-based criteria
for implantation

Al-Khatib et al...
In-hospital Outcomes

Outcome

Non–EvidenceBased ICD Implant
(N=25,145)

Evidence-Based
ICD Implant
(N=86,562)

P Value

O...
“We have emphasized this in the paper and in
every communication we have had about this
paper!”
“It should be pointed out ...
The AUC Document Does Not Help Us
Accomplish this Goal!
The ACC’s AUC

§  Although there is need for flexibility to deliver

optimal care to every patient, the AUC document
fail...
The Changing Health Care Environment
§ 

The Health Care Reform plan includes many quality
improvement initiatives
§ 
§...
Conclusions

§  There is compelling and convincing evidence that
ICD therapy improves survival in different patient
popul...
EP Summit 2014: Primary Prevention ICDs: Under-, Over- and Appropriate Usage
EP Summit 2014: Primary Prevention ICDs: Under-, Over- and Appropriate Usage
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EP Summit 2014: Primary Prevention ICDs: Under-, Over- and Appropriate Usage

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Transcript of "EP Summit 2014: Primary Prevention ICDs: Under-, Over- and Appropriate Usage"

  1. 1. Primary Prevention ICDs: Under-, Over- and Appropriate Usage Sana M. Al-Khatib, MD, MHS Associate Professor of Medicine Electrophysiology Section- Division of Cardiology Duke University
  2. 2. Potential Conflicts of Interest ■  I receive research funding from the National Heart, Lung and Blood Institute and from the Agency for HealthCare Research and Quality
  3. 3. Question # 1 ■  Which of the following is true: 1)  Studies have shown underutilization of primary prevention ICDs but not of secondary prevention ICDs 2)  When it comes to ICD use, there is evidence of racial disparities but not gender disparities 3)  Patients who are eligible for and receive a primary prevention ICD in clinical practice have a similar survival to patients who received an ICD in the RCTs of primary prevention ICDs (MADIT-II and SCD-HeFT)
  4. 4. Question # 2 ■  Is the following statement true or false: ■  Primary prevention ICDs are being overutlized in the United States; however, this overutilization is justified in all patients
  5. 5. Question # 3 ■  Which of the following is true about the ACC’s AUC criteria: 1)  They were developed to be used for reimbursement purposes 2)  They may inflict some risk on physicians 3)  They were mostly developed by implanting EPs
  6. 6. ICD Therapy Saves Lives! ICD therapy improves the survival of several patient populations at an increased risk for sudden cardiac death (SCD)
  7. 7. Al-Khatib et al. JAMA 2013
  8. 8. Curtis et al. JAMA 2007
  9. 9. Do Men Receive an ICD More Often Than Women? 3.15 2.61 3.73 2.44 2.19 2.66 1.96 Covariates included race, cerebrovascular disease, chronic pulmonary disease, coronary heart disease, dementia, diabetes mellitus, hypertension, metastatic solid tumor, peripheral vascular disease, renal disease, region, year of cohort entry. Curtis et al. JAMA 2007
  10. 10. Hernandez et al. JAMA 2007
  11. 11. Adjusted Odds for an ICD* N=13,034 35% of eligible patients either had an ICD in place or an ICD planned 0.73 Black male 0.62 White female 0.56 Black female 0 0.2 0.4 0.6 0.8 1.0 * Compared with white male Hernandez et al. JAMA 2007 A. Hernandez et al. JAMA 2007;298:1525-32
  12. 12. Al-Khatib et al. Circulation 2012
  13. 13. ICD Use in HF: Change in Sex and Race Disparities? ICD Use in 2005 and 2009 for Each Sex and Race Group. ICD use in 2005 (%) ICD use in 2009 (%) Adjusted OR(95% CI) for 2.5-year change* Black women 13.5 (12/89) 36.8 (57/155) 4.69 (1.90, 11.53) White women 23.1 (111/480) 31.1 (201/647) 1.97 (1.18, 3.32) Black men 24.5 (26/106) 47.2 (92/195) 3.04 (1.58, 5.87) White men 36.1 (309/856) 50.6 (641/1268) 1.79 (1.17, 2.74) *Period of (7/2007-12/2009) vs. 2005. The first 2.5 years of the study period were the only time during which there was change in the probability of receiving an ICD. Abbreviations: OR, odds ratio; CI, confidence interval. Al-Khatib et al. Circulation 2012
  14. 14. Kong et al. Am Heart J 2010
  15. 15. Al-Khatib et al. JAMA 2011
  16. 16. Rates of Non–Evidence-Based ICDs Across Sites 22.5% did not meet evidence-based criteria for implantation Al-Khatib et al. JAMA 2011
  17. 17. In-hospital Outcomes Outcome Non–EvidenceBased ICD Implant (N=25,145) Evidence-Based ICD Implant (N=86,562) P Value Overall population <0.001 Any adverse event (including death) 813 (3.23) [3.01-3.45] 2085 (2.41) [2.31-2.51] Hematoma 219 (0.87) [0.76-0.99] 615 (0.71) [0.65-0.77] 0.009 Death 143 (0.57) [0.48-0.66] 153 (0.18) [0.15-0.20] <0.001 Pneumothorax 111 (0.44) [0.36-0.52] 359 (0.41) [0.37-0.46] 0.56 Cardiac tamponade 14 (0.06) [0.03-0.08] 76 (0.09) [0.07-0.11] 0.11 Device infection 9 (0.04) [0.02-0.07] 14 (0.02) [0.01-0.03] 0.06 (N=22,123) (N=86,562) After excluding patients with NYHA class IV symptoms Any adverse event (including death) 659 (2.98) [2.75-3.20] 2085 (2.41) [2.31-2.51] < 0.001 Hematoma 188 (0.85) [0.73-0.97] 615 (0.71) [0.65-0.77] 0.03 Death 93 (0.42) [0.34-0.51] 153 (0.18) [0.15-0.20] < 0.001 Al-Khatib et al. JAMA 2011
  18. 18. “We have emphasized this in the paper and in every communication we have had about this paper!” “It should be pointed out that some of these implants may have been clinically appropriate. The guidelines clarify that “the ultimate judgment regarding care of a particular patient must be made by the health care provider and the patient in light of all the circumstances presented by that patient. There are circumstances in which deviations from these guidelines are appropriate.” Al-Khatib et al. JAMA 2011
  19. 19. The AUC Document Does Not Help Us Accomplish this Goal!
  20. 20. The ACC’s AUC §  Although there is need for flexibility to deliver optimal care to every patient, the AUC document fails to provide that in an unbiased, understandable and risk-free approach §  Some of the recommendations contradict the guidelines and CMS criteria for reimbursement §  AUC have not been shown to improve patient outcomes §  We need to focus on doing more research to support evidence-based practice!
  21. 21. The Changing Health Care Environment §  The Health Care Reform plan includes many quality improvement initiatives §  §  §  §  Quality measurement Public reporting Demand for transparency Appropriate use of CV care §  The Present: More and more emphasis is being placed on performance measures (outcome rather than process measures). Confidentiality of physicians’ performance is changing into public reporting of performance on a “physician compare” website §  2016/2017: Medicare reimbursement will be adjusted based on documented quality outcomes. Voluntary reporting will become mandatory reporting!
  22. 22. Conclusions §  There is compelling and convincing evidence that ICD therapy improves survival in different patient populations §  This is why underutilization and disparities in the use of this therapy are major problems that need to be addressed §  Overutilization is also a concern §  More efforts should focus on appropriate use of ICDs

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