Complex Coronary Cases Supported by: Abbott Vascular Boston Scientific Corporation Medtronic, Inc. AstraZeneca St Jude’s Medical Abiomed Vascular solution Bracco Diagnostic

Disclosures Samin K. Sharma, MBBS, FACC Speaker’s Bureau – Boston Scientific Corporation, Abbott Vascular Inc, AngioScore, The Medicines Company, Daiichi Sankyo, Inc. and Lilly USA, LLC Annapoorna S. Kini, MBBS, FACC Nothing to disclose Sameer Mehta, MBBS, FACC Consulting Fees – The Medicines Company American College of Cardiology Foundation staff involved with this case have nothing to disclose

Oct 15th 2013 Case #16: WA, 79 yr F Presentation: Patient with long standing CAD history, prior MIs and severe LV dysfunction, presented on Sept 9th, 2013 with NSTEMI and CHF. Cardiac cath revealed 3 V calcific CAD (subtotal distal RCA, 80% mid LAD, 70% OM2) and LVEF 22%; SYNTAX score 23. Attempt to open RCA was unsuccessful. Patient underwent cardiac MRI revealing viability in all segments and CT surgery declined by the pt. Prior History: Hypertension, Hyperlipidemia, NIDDM, CVA-recovered, A.fib, s/p colon and lung ca resection Medications: All once daily dosage Carvedilol 6.25mg, ISMN 30mg, Losartan 50mg, ASA 81mg, Atorvastatin 80mg, Metformin 1000mg, Clopidogrel 75mg 3

Case# 16: cont… Cardiac Cath 9/10/2013: Right Dominance 3 V CAD with LVEF 22% Left Main: No obstruction LAD: 80% calcific mid LAD, 60% D1 bifurcation LCx: 70% OM2 RCA: 80% mid and 99% distal severely calcified RCA lesion Pt underwent attempt to open RCA was unsuccessful because of inability to cross RCA lesion due to calcification and tortuosity. IABP was inserted post procedure for chest pain and pt had no peri-procedure MI. Plan Today: - PCI of calcific RCA and LAD with Impella LV assist device 4

Appropriateness Criteria for Coronary Revascularization

Issues Involving The Case LV support for High-risk PCI Appropriateness of PCI (stent use)

Issues Involving The Case LV support for High-risk PCI Appropriateness of PCI (stent use)

Percutaneous LV Assist Devices PTVA: TandemHeart IMPELLA: Recovers 2.5 IABP

Hemodynamic Comparison of IABP with Impella Pressure Loops of IABP vs. Impella Effect on Cardiac Work Balloon Pump Reduces systolic aortic pressure Increases SV Stroke Volume increase offsets pressure reduction Impella Unloads LV Reduces diastolic volume Volume Reduction Reduces PV loop area and cardiac work Jones et al., J Invasive Cardiol 2012;10:544

O’Neill et al., Circulation 2012;126:1717

PROTECT II Study: Effectiveness of Impella vs IABP Use During High-Risk PCI IABP Impella p=0.087 p=0.312 % 30 Day MAE 90 Day MAE O’Neill et al., Circulation 2012;126:1717

O’Neill et al., Circulation 2012;126:1717

PROTECT II Study: 90-Day MAE Impact of Time and Experience Years: 2009-2010 IABP 48.5% vs. 36.1% Impella 2.5 p=0.040 p=0.658 p=0.195 p=0.106 % N=66 N=69 N=85 N=91 N=68 N=64 O’Neill et al., Circulation 2012;126:1717

IMPELLA-EUROSHOCK Registry: Mortality at 30 Days and Secondary Efficacy Endpoints Baseline (N=120) Primary endpoint Mortality at 30 days (%) 64.2 Successfully weaned from support (%) 44.5 Long-term survival (after 317±526 days) (%) 28.3 Secondary endpoints Successful implantation procedure (%) 99.2 Duration of Impella-2.5-support, hours 43.5±49.6 In-hospital MACCE (%) 15 Vascular complications (%) 28.6 Plasma lactate at admission, mmol/L 5.8±5.0 Plasma lactate after 24 hours, mmol/L 4.7±5.4 Plasma lactate after 48 hours, mmol/L 2.5±2.6 Lauten et al., Circ Heart Fail. 2013;6:23

PLVAD Assistance in Post Cardiac Arrest Shock: Comparison of IABP and IMPELLA Recover LP2.5 Outcome IMPELLA (n=35) IABP (n=43) p Value Alive with CPC 1 on day 28 (%) 23 29.5 0.61 Death from shock (%) 57 27 0.01 Death from recurrent arrhythmia (%) 5.7 6.6 0.99 Death from anoxic encephalopathy (%) 8.6 37.2 0.007 Need for ECLS (%) 11 4.44 0.40 Serious bleeding complication (%) 26 9 0.06 Vascular complication (%) 3 2 0.90 Manzo-Silberman et al., Resuscitation 2013;8:609

PLVAD Support for High-Risk PCI and CS: In-Hospital Clinical Events Characteristics High Risk PCI (n=57) CS (n=17) IABP (n=35) PLVAD (n=22) p value IABP (n=13) PLVAD (n=4) p value Vascular complications (%) 9 0.07 - Acute stent thrombosis (%) 0.95 Recurrent MI (%) TVR (%) MACE (%) 11 0.78 46 50 0.89 In-hospital death (%) Shah et al., Cardiovasc Revasc Med 2012;13:101

PLVAD Support for High-Risk PCI and CS Reported Event Rates in Patients Requiring Hemodynamic Support for High-Risk PCI Author n Device Endpoint Rate (%) Dixon et al. 20 IMP Death, MI, TVR or CVA 30 days Henriques et al. 19 Mortality in hospital 10 Al-Husami et al. 6 TH Mortality 30 days 17 Froesch et al. 26 TH/IMP 14 Kovacic et al. 68 Death, MI, or TLR 30 days Shah et al. MACE in hospital 15 Shah et al., Cardiovasc Revasc Med 2012;13:101

LV Support during High-Risk PCI: LVEF + Lesion Complexity Simple PCI Complex PCI No support IABP Simple PCI Simple or Complex: Inoperable cases Complex PCI: High Syntax Score >32/STS>5 Extensive revasc. IABP Impella Impella/PTVA MSH: Of monthly 400 PCIs, approx 25 IABP (6.25%) and 4 Impella (1%) are used 18

Portable Heart-Lung Support System (LVAD/ECMO) The CARDIOHELP System is the world’s smallest portable heart-lung support system. It is ideal for use in critical care, cardiac catheterization laboratories, the operating room and trauma rooms. Furthermore, it is the perfect solution for safe and effective patient transport. As a result, there are now new opportunities and treatment possibilities for extracorporeal circulation for cardiac and/or pulmonary support 19

Issues Involving The Case LV support for High-risk PCI Appropriateness of PCI (stent use)

ACCF/SCAI/STS/AATS/AHA/ASNC 2009 & 2012 Appropriateness Criteria for Coronary Revascularization Patel et al. JACC 2009;53:530-553. Patel et al. JACC Jan30, 2012.

Appropriateness Use Criteria for PCI AUC Criteria from ACC-NCDR Results (n=500,00) 98.6 ALL ACS PCI (71%) Elective PCI (29%) 84.6 % 50.4 38.0 11.2 11.6 4.1 0.3 1.1 Appropriate Uncertain Inappropriate Paul Chan. JAMA 2011;306:53.

Chan et al., JACC Sept 2013, Accepted Manuscript

Patient and Hospital Characteristics Associated with Inappropriate PCI Results: Of 211,254 non-acute PCIs, 25,749 (12.2%) were classified as inappropriate. After multivariable adjustment, men (adjusted OR, 1.08 [95% CI: 1.05-1.11]; p=<0.001) and whites (adjusted OR, 1.9 [1.05-1.14]; p=<0.001) were more likely to undergo an inappropriate PCI, compared with women and non-whites. Compared with privately insured patients, those with Medicare (adjusted OR, 0.85 [0.83-0.88], other public insurance (adjusted OR, 0.78 [0.73-0.83]) and no insurance (adjusted OR, 0.56 [0.50-0.61]) were less likely to undergo an inappropriate PCI (p=<0.001). Additionally, compared with urban hospitals, those admitted at rural hospitals were less likely to undergo inappropriate PCI, whereas those at suburban hospitals were more likely. Chan et al., JACC Sept 2013, Accepted Manuscript

Patient and Hospital Predictors of Inappropriate PCI HOSPITAL VARIABLES 95% Confidence Interval p Value Hospital location (reference: urban) <0.001 Rural 0.92 (0.88-0.96) Suburban 1.10 (1.07-1.13) Teaching hospital 0.98 (0.95-1.01) 0.11 Public hospital 1.02 (0.99-1.05) 0.25 For-profit status (reference: university) 0.28 Government 0.87 (0.74-1.04) Private 1.00 (0.96-1.05) Onsite cardiothoracic surgery 1.03 (0.99-1.08) 0.20 Annual elective PCI volume, per 100 cases 0.99 (0.99-0.99) Chan et al., JACC Sept 2013, Accepted Manuscript

MSH 3.7% Hannan E et al. JACC 2012;59:1870. 27

Appropriateness of Revascularization by PCI: NY State vs Appropriateness of Revascularization by PCI: NY State vs. MSH for Stable CAD in 2010 % NYS MSH N Stable CAD % Not Rated % NYS 14743 37.4 27.5 MSH 2575 62.3 13.7 28 28

Appropriateness of PCI AUC Metrics at MSH compared to ACC-NCDR (n=1500 hospitals) for July-Dec 2012 Proportion of non-ACS PCI procedures at MSH classified Inappropriate %

Appropriateness of PCI AUC Metrics at MSH compared to ACC-NCDR (n=1500 hospitals) for Jan-June 2013 Proportion of non-ACS PCI procedures at MSH classified Inappropriate %

Pattern and Intensity of Optimal Medical Therapy (OMT) during PCI: Impact of COURAGE Trial: Data from ACC-NCDR CathPCI Registry PRE- COURAGE (n=173,416) Post- COURAGE (n=293,795) 66.0 63.5 64.3 61.8 % 43.5 44.7 40.0 41.1 OMT Pre-PCI OMT Post-PCI OMT Pre-PCI OMT Post-PCI All Cases (N=467,211) COURAGE Trial type Cases (N=265,184) W Borden et al. JAMA 2011;305:1882

Distribution of Appropriateness Score ACC Appropriateness Score Inappropriate scores Uncertain scores Appropriate scores (%) 18% 68% ACC Appropriateness Score Ko et al., J Am Coll Cardiol 2012;60:1876

Treatment According to Appropriate Categories Ko et al., J Am Coll Cardiol 2012;60:1876

Death or ACS at 3 Years According to AUC Criteria Revascularization No Revascularization p=0.0087 p=0.12 p=0.97 % n=991 n=326 n=311 Ko et al., J Am Coll Cardiol 2012;60:1876

Outcomes of PCI Patients According to Procedural Appropriateness Inappropriate (N=54) p=0.43 Uncertain (N=1604) p=0.08 p=<0.001 p=0.01 % p=0.25 p=0.32 In-hospital 30-day MACE Mortality 1-yr MACE Mortality TVR Major Comp Barbash et al., Cardiovasc Revasc Med 2013, Article in Press

Multivariable Analysis for Predictors of In-Hospital Mortality Hazard Ratio 95% Confidence interval P Value Lower HR Upper HR “Appropriate” vs “Inappropriate” 0.31 0.09 1.02 0.05 “Uncertain” vs “Inappropriate” 0.41 0.12 1.39 0.15 Hypertension 0.85 0.34 2.12 0.73 Diabetes mellitus 2.04 1.12 3.70 0.02 Hypercholesterolemia 0.44 0.22 0.90 Smoker 0.35 1.55 0.42 Peripheral vascular disease 2.10 1.08 4.08 0.03 Previous CABG 1.36 0.51 3.65 0.54 History of CAD 0.76 1.69 Family history of CAD 0.28 0.13 0.62 0.001 LAD PCI 1.56 0.83 2.91 0.17 AHA/ACC type C lesion 1.64 0.92 2.93 DES <0.001 Barbash et al., Cardiovasc Revasc Med 2013, Article in Press

JACC Cardiovasc Interv 2012;5:801

CMS doubles down on appropriateness with new prepayment review demonstration

Take Home Message: LV support for High-risk PCI and Appropriateness of PCI LV support during high-risk PCI using Impella seems to have advantage (trend for lower MACE) over IABP but is associated with higher vascular complications (higher sheath size 13Fr for Impella vs. 7.5Fr for IABP. Role of both Impella or IABP in CS despite their ubiquitous use, is questionable and can’t be supported by published data. Interventionalists have to take the prime responsibility of following the appropriate use criteria for PCI and use stents only in appropriate clinical and angiographic scenario.

Question # 1 Which of the following statement is true for Impella vs. IABP in the PROTECT II Trial of high-risk PCI: Impella use reduced mortality Impella use decrease MI Impella use decreased CVA Impella use decreased vascular complications Impella use decreased TVR

Question # 2 As per ACC-NCDR data, what is the range of PCIs classified Inappropriate for the stable CAD at the present time : <5% 5-10% 11-20% 20-30% >30%

Question # 3 Following characteristics are associated with higher Inappropriate PCI use in stable CAD except : A. White race B. Female gender C. Urban hospitals D. Commercial insurance provider E. Lower baseline hospital PCI volume

Question # 1 Which of the following statement is true for Impella vs. IABP in the PROTECT II Trial of high-risk PCI: Impella use reduced mortality Impella use decrease MI Impella use decreased CVA Impella use decreased vascular complications Impella use decreased TVR The correct answer is E as Impella use was associated with lower TVR at 90 days while other parameters did not differ significantly O’Neill et al., Circulation 2012;126:1717

Question # 2 As per ACC-NCDR data, what is the range of PCIs classified Inappropriate for the stable CAD at the present time : <5% 5-10% 11-20% 20-30% >30% The correct answer is C as 12-19% PCIs are classified as Inappropriate from ACC NCDR data Paul Chan. JAMA 2011;306:53. Chan et al., JACC Sept 2013, Accepted Manuscript

Question # 3 Following characteristics are associated with higher Inappropriate PCI use in stable CAD except : A. White race B. Female gender C. Urban hospitals D. Commercial insurance provider E. Lower baseline hospital PCI volume The correct answer is B as all other scenarios are associated with higher Inappropriate PCI use Chan et al., JACC Sept 2013, Accepted Manuscript