AICD usage for primary prevention at Mercy Hospital: successes, challenges and next steps Mohammad Tahir PGY-3

Automatic Implantable Cardioverter Defibrillator AICD: shock therapy in the event of VT/VF Indicated for prevention of suddent cardiac death (SCD) Secondary prevention: resuscitation after VT/VF arrest Primary prevention: high risk for development of VT/VF

Background MADIT-I Trial 1 : mortality benefit in post MI, NSVT & LVEF <35% MADIT-II Trail 2 : mortality benefit in post MI & LVEF <30% ACC/AHA : for LVEF <30% (class IIa) SCD-HeFT Trial 4 : mortality benefit in ischemic & non-ischemic CM, LVEF <35% 1 Moss AJ et al. N Engl J Med 1996;335: Moss AJ et al. N Engl J Med Mar 21;346: ACC/AHA/NASPE 2002 Guideline Update Circulation 2002;106; Bardy GH et al. N Engl J Med 2005;352:

Adapted from: ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities J. Am. Coll. Cardiol. 2008;51;e1-e62; May 15, 2008.

Background (contd…) ACC/AHA 2008: LVEF <35% –Post MI (after 40 days), NYHA II/III (class I) –Non-Ischemic NYHA II/III (class I) Cost effective: QALY, Hospitalization ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities J. Am. Coll. Cardiol. 2008;51;e1-e62; May 15, 2008.

Objectives To determine the proportion of eligible patients receiving or referred to AICD implantation To analyze the factors affecting the referral

Methodology Retrospective Chart review IRB Approval: consent waived Duration: Jan-July 2008 Data Abstracted on –Demographics –Duration of CHF –Ischemic/ Non-ischemic Cardiomyopathy, –History of coronary artery disease, diabetes, hypertension, chronic kidney disease, pacemaker implantation, CABG or PCI

Methodology (contd…) –Baseline rhythm: sinus rhythm/ atrial fibrillation, –QRS complex duration –Use of medications including beta blocker, ACE inhibitor, digoxin, anti-arrhythmic drugs (amiodarone), anti-coagulation with Coumadin, –New York Heart Association (NYHA) class for CHF –Pedal edema –Acute myocardial infarction (AMI) during current hospital admission

Inclusion criteria All hospital discharges with a primary or secondary diagnosis of Heart Failure or Cardiomyopathy Evidence of LVEF <35% –Echocardiography –Nuclear stress test –MUGA Scan –Left Ventriculography

Exclusion Criteria In-hospital death AICD previously implanted (in-situ) Discharge to hospice services Comfort measures only

Data Analysis Variables abstracted in MS excel Analysis software: SPSS & Epi Info Chi-square test: Categorical Variables Independent sample t-test: Continuous variables Statistical significance: p <0.05.

Results

AICD previously implanted 35 Hospice/comfort care 13 Total patients with LVEF ≤ 35% 208 In-Hospital Death 15 Study Population N=145 Referred Group 77 (53%) Unreferred Group 68 (47%)

Patient refusal for AICD 9 (12%) Re-evaluation after optimization of therapy 8 (10%) Referred Group (n=77) Out-patient evaluation for AICD 16 (21%) AICD implanted during hospitalization 41 (53%) AICD deferred in view of risk vs. benefit 3 (4%)

Clinical Variables of ‘referred’ (n=77) and ‘unreferred’ (n=68) groups Demographic and clinical Characteristics Referred Group (N=77) Unreferred Group (N=68) P-Value Age in years, Mean ± SD69.9 ± ± 12.0<0.01 Sex, females, n (%)27 (35.1)28 (41.2)0.5 Non-White race n (%)4 (5.2)4 (1.5)1.0 NYHA class IV, n(%)8 (10.4)3 (4.4)0.29 NYHA class II / III, n (%)69 (89.6)65 (95.6)0.29 Acute/ exacerbation CHF, n (%)52 (67.5)45 (66.1)0.99

Clinical Variables of ‘referred’ (n=77) and ‘unreferred’ (n=68) groups Demographic and clinical Characteristics Referred Group (N=77) Unreferred Group (N=68) P-Value Pedal Edema present, n (%)20 (26)17 (25)0.95 Diabetes, n (%)33 (42.9)28 (41.2)0.97 Hypertension, n (%)63 (81.8)57 (83.8)0.92 Acute Myocardial Infarction, n (%) 11 (14.3)13 (19.1)0.58 H/o Coronary artery Disease, n (%) 51 (66.2)42 (61.8)0.7 H/O CABG, n (%)26 (33.8)24 (35.3)0.99

Clinical Variables of ‘referred’ (n=77) and ‘unreferred’ (n=68) groups Demographic and clinical Characteristics Referred group (N=77) Unreferred group (N=68) P-Value H/O PCI, n (%)6 (7.8)7 (10.3 )0.81 H/O Pacemaker Implantation, n (%) 6 (7.8)9 (13.2)0.42 CKD stage ≥3,n (%)20 (26 )23 (33.8)0.4 Beta Blocker at admission, n (%)51 (66.2)40 (58.8)0.45 Beta Blocker at discharge, n (%)66 (85.7)56 (82.4)0.75

Clinical Variables of ‘referred’ (n=77) and ‘unreferred’ (n=68) groups Demographic and clinical Characteristics Referred Group (N=77) Unreferre Group (N=68) P-Value Digoxin use at at admission, n (%)16 (20.8)11 (16.2)0.62 Coumadin Use at admission, n (%)16 (20.8)19 (27.9)0.42 Anti-arrythmics use at admission, n (%) 2 (2.6)1 (1.5)1.0 ACE inhibitor at discharge, n (%)56 (72.7)47 (69.1)0.77 ACE inhibitor at admission, n (%)43 (55.8)37 (54.4)1.0

Imaging/ EKG variables of ‘referred’ (N=77) and ‘unreferred’ (N=68) groups Characteristic Referred group (N=77) Unreferred group (N=68) P-Value LVEF (%), Mean ± SD25.6 ± ± 6<0.01 Ischemic Cardiomyopathy, n (%) 50 (65)42 (62)0.82 Coronary Angiogram done, n (%) 28 (36.4 )12 (17.6 )0.02 LVEF on angiogram (%), Mean ± SD 24.6 ± ± Sinus Rhythm45 (58.4)36 (52.9)0.62

Imaging/ EKG variables of ‘referred’ (N=77) and ‘unreferred’ (N=68) groups Characteristic Referred Group (N=77) Unreferred Group (N=68) P-Value Atrial Fibrillation23 (29.9)26 (38.2)0.38 QRS duration (ms), Mean ± SD ± ± LVEDD (mm) Mean ± SD60.9 ± ± 7.0<0.01 Severe Aortic Stenosis, n (%) 1 (1.3)8 (11.8)0.01 Severe Mitral regurgitation, n (%) 3 (3.9)5 (7.4)0.59 Severe Aortic regurgitation, n (%) 1 (1.3)1 (1.5)1.0

Limited F/U data Cross sectional One patient from each group was found to have AICD implanted in the interim period before second hospitalization.

Discussion Only 53% of eligible patients had documentation of such discussion AICD implantation: 53% of those referred Referred Patients: –Younger –Lower EF

Discussion (contd..) Most of the patients with severe Aortic Stenosis: in unreferred group –The need of aortic valve replacement evaluation being of paramount importance. –Not considered immediate candidates –Such documentation was missing.

Discussion (contd..) Coronary Angiogram: 36.4 % in referred group vs. 12 % in unreferred group –Patients undergoing coronary angiogram more likely to have a discussion about the AICD. –Acute presentation –Consultative assistance

Discussion (contd..) Significant difference in the mean LVEDD: –likely an incidental finding –Sicker patients with lower EF. Also noted that, recommendations made after procedures such as coronary angiograms were more likely to be followed by the team.

Conclusions AICD referral in only 53 % –Need for improvement. Hospitalization provides an opportunity: –Greater amount of time spent by patients –Make an in-depth assessment –Involve cardiovascular specialist –Referral/ recommendations. –Likely to be followed as out-patient as in CHF 1 1 Reibis R, Dovifat C, Dissmann R, et al. Clin Res Cardiol Mar;95(3):

Limitations Retrospective review type Cross sectional Dependence on documented medical information.

Recommendation Despite limitations: –A real life patient care outcome report –Insight for the need to improve. Creation of ‘centralized recommendation’ from points of diagnostic procedures –Echocardiogram –Radionuclide cardiac imaging –Left ventriculography. Importance of medical records documentation Continued education of all the providers

Acknowledgement Dr. Aravind Herle Dr. Syed J Noor Dr. Khalid J Qazi CHS IRB Team HIM Staff