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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 Trial1: mortality benefit in post MI, NSVT & LVEF <35% • MADIT-II Trail2: mortality benefit in post MI & LVEF <30% • ACC/AHA 20023: for LVEF <30% (class IIa) • SCD-HeFT Trial4: mortality benefit in ischemic & non-ischemic CM, LVEF <35% 1Moss AJ et al. N Engl J Med 1996;335:1933-1940 2Moss AJ et al. N Engl J Med. 2002 Mar 21;346:877-83. 3ACC/AHA/NASPE 2002 Guideline Update Circulation 2002;106;2145-2161. 4Bardy GH et al. N Engl J Med 2005;352:225-237. 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 Total patients with LVEF ≤ 35% 208 In-Hospital Death 15 AICD previously implanted 35 Hospice/comfort care 13 Study Population N=145 Referred Group 77 (53%) Unreferred Group 68 (47%) Referred Group (n=77) Out-patient evaluation for AICD 16 (21%) Re-evaluation after optimization of therapy 8 (10%) Patient refusal for AICD 9 (12%) AICD deferred in view of risk vs. benefit 3 (4%) AICD implanted during hospitalization 41 (53%) Clinical Variables of ‘referred’ (n=77) and ‘unreferred’ (n=68) groups Referred Group (N=77) Unreferred Group (N=68) P-Value 69.9 ± 14.6 76.0 ± 12.0 <0.01 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 Demographic and clinical Characteristics Age in years, Mean ± SD Sex, females, n (%) 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 ± SD 25.6 ± 6.3 28.9 ± 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 ± 8.0 19.5 ± 13.6 0.14 Sinus Rhythm 45 (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) 26 (38.2) P-Value Atrial Fibrillation 23 (29.9) 0.38 QRS duration (ms), Mean ± SD 127.2 ± 41.5 120.0 ± 31.5 0.27 LVEDD (mm) Mean ± SD 60.9 ± 8.0 56.9 ± 7.0 <0.01 Severe Aortic Stenosis, n (%) 1 (1.3) 8 (11.8) 0.01 Severe Mitral regurgitation, 3 (3.9) n (%) 5 (7.4) 0.59 Severe Aortic regurgitation, 1 (1.3) n (%) 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 CHF1 1Reibis R, Dovifat C, Dissmann R, et al. Clin Res Cardiol. 2006 Mar;95(3):154-61. 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