Training a Team of Skilled Operators

Jeffrey W. Moses, MD John and Myrna Daniels Professor of Cardiology Director, Interventional Cardiac Therapeutics Columbia University Medical Center Director Complex Coronary Interventions St. Francis Hospital, Roslyn, LI Disclosure Statement of Financial Interest

I, Jeffrey W. Moses, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation. Perspective on PCI in the Past Decade

• Coronary population in the cath lab suffered precipitous decline • A philosophy of “watchful waiting” (i.e., let’s let things get really bad first) otherwise known as GDMT holds sway Algorithm for Guideline-Directed Medical Therapy for Patients With SIHD* (cont.)

* Colors correspond to the ACCF/AHA Classification of Recommendations and Levels of Evidence Table. The Basic CHIP Premise • There is a large underserved patient population that can benefit from revascularization

 Rather than focusing on low-risk patients who may be “easy to treat”, we need to focus upon higher-risk patients who have the most to gain

 These patients will be more commonly seen as our field / the healthcare system evolves

 The development of comprehensive specialists trained with advanced technical and cognitive skills to assess and treat these patients is clearly needed Cardiogenic Shock or Arrest* *SCAI Shock Categories: B-E E

Inpatient Hospital Complex Comorbidity** or Complex PCI*** **Complex comorbidity: ACS, low EF<30%, NYHA HF Class III-IV, CKD eGFR <45, severe anemia, severe contrast allergy, severe aortic stenosis, severe PAD, recent TIA/stroke, severe coagulopathy, severe pulmonary hypertension or severe lung C disease ACS Hospital ***Complex PCI: SVG, UPLM, bifurcation with severe side branch lesion, severe calcification CTO, MCS, coronary Ambulatory or thrombosis, three vessel PCI, last remaining conduit, or severe tortuosity Inpatient Non-ACS Hospital preferred

Stable CAD without Complexity A Ambulatory Surgical Ambulatory Center or Hospital

Patient Status Performance Center

Riley et al. Catheter Cardiovasc Interv. 2020;1-17 Multivessel CAD Calcified Lesions Left Main Disease Bifurcation Lesions In-stent Restenosis Chronic Total Occlusions Saphenous Vein Graft Disease ANATOMY

COMPLEX Diabetes Mellitus PCI Atherectomy CABG Ineligibilty Covered Stents Cardiogenic Shock Intravascular Imaging Valvular Heart Disease Specialty Coronary Wires Acute Coronary Syndrome Intracoronary Physiology Renal Insufficiency/Dialysis Guide Cathether Extensions Impaired Ventricular Function Embolic Protection Devices Mechanical Circulatory Support COMORBIDITIES EQUIPMENT

Riley et al. Catheter Cardiovasc Interv. 2020;1-17 Cath Lab Population is Aging

100

40 Proportion (%) 20

0 2000-2002 2003-2005 2006-2008 Time <39 years 60-79 years 40-59 years >80 years

Rajani et al. Br J Cardiol 2011; 18:73-76. Cath Lab Population is Getting Sicker: NCDR 2009-2014

Angina Severity 3-4 16% 38%

High Risk 22% 33%

Acute PCI 378K 375K

Non-acute 90K 60K

Desai et al, JAMA 2015;314:2045-53 Co-morbidity in the Cath Lab is Increasing 2004-2014 n=6,601, 526 PCI

100.00% 6.30% 6.40% 5.40% 6.40% 7.50% 7.50%10.10% 11.50% 11.90% 13.00% 14.20% 90.00% 13.50% 13.40% 13.80% 14.80% 15.40% 16.30% 16.60% 80.00% 17.60% 18.00% 18.50% 18.80% 70.00%

34.60% 34.50% 35.20% 60.00% 35.30% 35.30% 34.50% 34.00% 33.50% 33.50% 50.00% 32.90% 32.80% 40.00% 30.00% 46.60% 46.80% 20.00% 45.60% 43.50% 41.80% 39.80% 39.30% 37.30% 36.60% 35.60% 34.20% 10.00% 0.00% 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 CCI=0 CCI=1 CCI=2 CCI≥3

Rios et al, DOI:10.1016/j.amjcard.2018.07.011 Comorbidity and Increased Risk of Complications

Charlson Comorbidity Index Score 1 v 0 2 v 0 ≥3 v 0

In-hospital mortality 1.19 (1.15, 1.25) 1.41 (1.34, 1.48) 1.96 (1.86, 2.07)

Any complication 1.23 (1.21, 1.27) 1.66 (1.61, 1.70) 2.47 (2.38, 2.56)

Bleeding complication 1.57 (1.52, 1.61) 2.47 (2.39, 2.56) 4.26 (4.09, 4.42)

Vascular complication 1.06 (1.02, 1.10) 1.09 (1.03, 1.15) 1.12 (1.05, 1.20)

Cardiac complication 0.94 (0.91, 0.97) 0.94 (0.90, 0.99) 1.00 (0.95, 1.04)

Stroke 1.30 (1.26, 1.34) 1.72 (1.67, 1.79) 2.40 (2.30, 2.51)

Rios et al, DOI:10.1016/j.amjcard.2018.07.011 Is It Worth the Effort? Survival in “No-option” Patients Based on Subsequent Revascularization and Type

(a) 100 (b) 100

90 95 90 80 85

70 80 Log-rank test: p=0.50

Mortality (%) Mortality Log-rank test: p<0.01 75 60 (%) Mortality CABG 70 Existing Lesion No Revasc Performed

Freedom from All-cause from Freedom New Lesion

Freedom from All-cause Freedom from 65 50 Revasc Performed Restenosis 0 2 4 6 8 10 60 0 1 2 3 4 5 Time from No-option Designation (years) Time from No-option Designation (years) No. at Risk: No Revasc 1043 866 747 623 438 255 Revasc 342 320 286 260 197 99

Sharma et al. Catheter Cardiovasc Interv. 2018;00:1-5 “The CHIP Operators Creed” The indications for the case do not change just because the lesion is “harder to treat” The CHIP Message

• The revascularization must be able to be done safely and with high quality and/or durability • The revascularization being performed has to be performed on lesions that are of prognostic or symptomatic importance

 Ischemia-based lesion assessment These Patients Present Complex Issues to the Interventional Cardiologist

• Higher risk of complications • Less tolerance of imperfect outcomes • Need to be acquainted with advanced PCI techniques Underscores the Need for CHIP Specific Training And Skills With Increasing CHIP Experience and Tools, Outcomes are Improving 1.0 0.1 4 0.08 0.8 0.08 0.23 0.08 3 0.6 0.28 0.23 2 0.05 0.4 0.08 0.05 1 Proportion (%) 0.49 (%) MACCE Rate 0.2 0.42 0.29 0 0.0 2000-2002 2003-2005 2006-2008 2000-2002 2003-2005 2006-2008 Time Time

CVA STEMI Overall MACCE <80 years Emergency CABG In-hospital Non-elective >80 years mortality Elective

Rajani et al. Br J Cardiol 2011; 18:73-76. UK Central Audit: CTO and Mortality n=13,443 Patients

Complete revascularization Partial revascularization – HR .72 p<.001 Failed revascularization – HR .61 p=0.002 10%

Cumulative Mortality 2%

0 .5 1 1.5 2 2.5 3 3.5 4 Follow-up Time (Years)

George et al, J Am Coll Cardiol 2014;64:235-43 Death or MI Rate (%) COURAGE: Residual Ischemia on6-18mMPS (n=23) 0% Shaw LA et al. p=0.063 Rates ofDeathorMIby 1%-4.9% (n=141) Circulation 2008;117:1283-91 p=0.023 5%-9.9% (n=88) p=0.002 (n=62) >10% PROTECT II: MACCE Outcomes Based on the Extent of Revascularization

(All Patients, N=413) IABP IMPELLA p=0.489

36% p=0.007 30% 28% ↓ 46% MACCE 90 day MACCE 15%

N=54 N=65 N=145 N=133

Limited Revascularization Extensive Revascularization IZ [0-2] IZ [3-11] Extent of Revascularization So How Are We Performing With Complex Patients? Let’s Look at 2 Scenarios

• Complete Revascularization • Left Main PCI Complete Revascularization Is a Key Objective Meta-analysis 38 Studies 156K Patients

Death 0.69 (0.61-0.78) MI 0.64 (0.50-0.81) Revasc 0.60 (0.45-0.80)

MACE 0.63 (0.50-0.79)

CTO 0.65 (0.53-0.80)

Conclusion: Mortality and Morbidity Increases with Degree of IR

Nagaraja et al. J Am Heart Assoc. 2016; 5:e004598 Hazards of Incomplete Revascularization: New York, 2010-2012 Non-STEMI (N = 35,993)

Observed Type of Revascularization No. (%) Mortality Rate, % Adjusted HRc (95%CI) P Value Complete revascularization 10 059 (31.71) 10.15 1 [Reference] NA Highest stenosis in incomplete lesion, %d 70-89 11 461 (36.13) 12.96 1.18 (1.09-1.28) <.001 >90 10 205 (32.17) 17.71 1.36 (1.25-1.47) <.001 >90 vs 70-89 NA NA 1.15 (1.07-1.24) <.001 Vessels incomplete, No. None 10 261 (28.51) 10.19 1 [Reference] NA 1 17 925 (49.50) 14.39 1.22 (1.13-1.31) <.001 2 or more 7807 (21.69) 20.10 1.42 (1.30-1.55) <.001 2 or more vs. 1 NA NA 1.17 (1.09-1.59) <.001 Location of incomplete vessel Complete revascularization 10 261 (28.51) 10.19 1 [Reference] NA Not PLAD 23 230 (64.54) 15.62 1.26 (1.17-1.35) <.001 PLAD 2502 (6.95) 20.78 1.40 (1.25-1.57) <.001 PLAD vs. not PLAD NA NA 1.11 (1.01-1.23) .03

Hannan et al. JAMA Cardiol. 2017; doi:10.1001 How Are We Doing? Incomplete Revascularization Is Increasing in NY! Operator and Hospital IR Rates n=27,860

70 68 66 64 62 60 58 IR Rate (%) 56 54 52 50 07/09-12/09 01/10-06/10 07/10-12/10 01/11-06/11 07/12-12/12 01/12-06/12 Time Period (P value for trend test = 0.04) Rate of IR for PCI: July 2009 to June 2012

Hannan et al. Am Heart J 2017;186:118-26 Physician and Hospital Relationship with IR

IR for non-MI PCI: Outlier Status and Volume of Operators

Risk adjusted Observed IR outliers n%Volume (%)IR rates* range IR rate

Low outlier 75 18.6 7,973 (28.3) 0.25-0.59 44.7

Not outlier 277 68.7 13,990 (50.8) 0.46-0.80 66.3

High outlier 51 12.7 5,597 (20.3) 0.69-0.88 81.0

You can more than double your chance of CR with the right operator!

Hannan et al. Am Heart J 2017;186:118-26 What About Left Main PCI? AUC in Left Main Coronary Artery Stenosis

Asymptomatic Ischemic Symptoms Not on AA Therapy or with Not on AA On 1 AA Drug AA Therapy Therapy (BB Preferred) On ≥2 AA Drugs Indication PCI CABG PCI CABG PCI CABG PCI CABG • Isolated LMCA disease M (6) A (8) A (7) A (8) A (7) A (9) A (7) A (9) • Ostial or midshaft stenosis • Isolated LMCA disease M (5) A (8) M (5) A (8) M (5) A (9) M (6) A (9) • Bifurcation involvement • LMCA disease • Ostial or midshaft stenosis • Concurrent multivessel disease M (6) A (8) M (6) A (9) A (7) A (9) A (7) A (9) • Low disease burden (e.g., 1-2 additional focal stenoses, SYNTAX score ≤22) • Ostial or midshaft stenosis • Concurrent multivessel disease • Intermediate or high disease burden (e.g., 1-2 M (4) A (9) M (4) A (9) M (4) A (9) M (4) A (9) additional bifurcation stenosis, long stenoses, SYNTAX score >22) • LMCA disease • Bifurcation involvement M (4) A (8) M (5) A (8) M (5) A (9) M (6) A (9) • Low disease burden in other vessels (e.g., 1-2 additional focal stenosis, SYNTAX score ≤22) • LMCA disease • Bifurcation involvement • Intermediate or high disease burden in other vessels R (3) A (8) R (3) A (9) R (3) A (9) R (3) A (9) (e.g., 1-2 additional bifurcation stenosis, long stenoses, SYNTAX score >22)

Patel et al, J of Am Coll.of Cardiology. 2017 in press EXCEL Registry (n=1,000) Major reasons for exclusion Treatment from randomization of registry patients 50-<70% LM stenosis which did not meet 29.9% criteria for hemodynamic significance

Site-assessed SYNTAX 38.1% score ≥33 33.1% 64.8%

Heart team consensus of 36.0% ineligibility for PCI

Heart team consensus of 2.1% 17.1% ineligibility for CABG CABG PCI No revasc 0% 10% 20% 30% 40% 50% Of the 1747 pts enrolled during the registry period, 62% were eligible for PCI (1078; 331 reg + 747 rand), and 80% were eligible for CABG (1395; 648 reg + 747 rand) Left Main Volume/Outcomes Relationship 6,724 cases from BCIS 2012-2014

100 90

80 70 60 50 40 Percentage 30 20 10 0 0 10 20 30 40 50 60 Annualized uLMS-PCI Operator Volume

Kinnaird et al. Circ Cardiovasc Interv. 2020; 13:e008782. DOI:10.1161 Cumulative Incidence (%) Survival byOperatorVolume 10 15 5 0 1231 1285 1440 1404 0 1189 1216 1357 1324 1 1184 1208 1346 1310 2 Kinnaird etal. Quartile 4 Quartile 3 Quartile 2 Quartile 1 1178 1187 1331 1300 3 1172 1182 1321 1293 13:e008782. DOI:10.1161 4 icCrivs Interv. Circ Cardiovasc 1166 1181 1308 1284 5 Month 1147 1150 1267 1237 6 1114 1107 1219 1188 7 1054 1058 1190 1123 8 1048 1025 1145 1072 2020; 9 p <0.001 for trend 1022 1110 1031 985 10 1076 966 985 978 11 1018 954 983 932 12 Odds ratio 0.0 0.5 1.0 1.5 2.0 1 0.76 [0.56:1.05] 0.76 * Comparisonvs.Q1 p In-hospital MACCE <0.001 Quartile 2 0.60 [0.44:0.84] 0.60 *p for linear trend <0.002 3 0.41 [0.27:0.62] 0.41 *p <0.001 4 Kinnaird etal.

Odds ratio 0.0 0.5 1.0 1.5 2.0 13:e008782. DOI:10.1161 LM BCIS 1 0.82 [0.57:1.18] 0.82 icCrivs Interv. Circ Cardiovasc In-hospital mortality p <0.003 Quartile 2 0.64 [0.43:1.18] 0.64 *p for linear trend =0.037 3 0.39 [0.24:0.67] 0.39 *p <0.001 4

2020; Odds ratio 0.0 0.5 1.0 1.5 2.0 1 1.01 [0.87:1.38] 1.01 p< 12-month mortality 0.001 Quartile 2 0.98 [0.77:1.25] 0.98 for linear trend 3 0.54 [0.39:0.73] *p <0.001 4 LM BCIS

Peri-procedural MI In-hospital major bleeding Any procedural complication 2.0 p=0.029 for linear trend 2.0 p=0.488 for linear trend 2.0 p=0.037 for linear trend 0.77 [0.34:1.76] 0.75 [0.38:1.50] 1.5 1.5 0.74 [0.36:1.49] 1.5 0.91 [0.68:1.20] 0.44 [0.17:1.13] 0.57 [0.27:1.17] 0.83 [0.62:1.18] 0.64 [0.47:0.87] 1.0 1.0 1.0 *p=0.006 0.12 [0.02:0.54] 0.5 0.5 0.5 Odds ratio Odds ratio Odds ratio *p=0.005 0.0 0.0 0.0 1 2 3 4 1 2 3 4 1 2 3 4 Quartile Quartile Quartile

* Comparison vs. Q1

Kinnaird et al. Circ Cardiovasc Interv. 2020; 13:e008782. DOI:10.1161 LM PCI in the US (NCDR) 3,342,162 Patients 33,128 LM

Valle et al, JAMA Cardiol. 2019;4:100-109 Mean Annual LM PCI Volume US

• Operators 0.5/yr • Facilities 3.2/yr • 46% hospitals 84% operators, <1 yr

Valle et al, JAMA Cardiol. 2019;4:100-109 And this is Why, with SKILLSET (and Volume) Growth…

Michael et al. Catheter Cardiovasc Interv 2015;85:393-9 Brilakis et al. J Am Coll Cardiol Intv 2015;8:245–53 CTO Michigan BC Database 2010-2017 n=7,389

15 100

12 80 Procedural Success(%)

9 60

6 40

CTO and MACE and (%) CTO 3 20

0 0 2010 2011 2012 2013 2014 2015 2016 2017 Year

CTO Rate (Among all cases) MACE Rate in CTO cases Procedural Success in CTO cases

Othman et al. J Am Coll Cardiol Intv 2020;13:1357-68 CHIP Components CHIP Growth England & Wales

25000 40 36.7 35.7 36.2 35 33.3 33.8 19089 18808 18650 31.9 20000 17930 31.3 17305 17830 17381 17371 30 28.1

15000 25

10692 20 100989647 8816 8909 9159 10000 8680 6747 15

Number of PCIs Number of 10 5000 5

0 0 2007 2008 2009 2010 2011 2012 2013 2014 2007 2008 2009 2010 2011 2012 2013 2014 Non CHIP CHIP PCI CHIP-PCI of Total as a Percentage Study Years

Kinnaird et al. Am Heart J 2020;222:15-25 Operator Volumes BCIS: 30K “CHIP” Procedures 2007-2014

30 Q1 Q2 Q3 Q4 25 n=7,543 n=7,458 n=7,647 n=7,729

Number of Operators Number of 5

0 1 11 21 31 41 5161 71 81 91 101 111 121 131 141 151 161 171 181 191 201 211 221231241 251 261 271 281 291 301 311321 331 341 351 361 371 381 391 401 411 421 431 441 451 461 471 481 491 501 511 521 531 541 551 561 571 581 Volumes of CHIP-PCI per Operator 2012-2014

Kinnaird et al. Am Heart J 2020;222:15-25 In-hospital MACCE

3.5 P=.041 for linear trend 3.0

2.5

2.0

1.5 1.04 [0.69-1.47] 0.73 [0.49-1.09] 0.61 [0.41-0.93] 1.0

0.5 P=.012 0.0 Q1 Q2 Q3 Q4

No Difference in 1-year Death

Kinnaird et al. Am Heart J 2020;222:15-25 High-risk Patients Hidden in Plain Sight

Inconsistent High Risk Population Treatment inconsistently managed or No Treatment

Current patient population found in: – Hospital Fewer than 1 in 10 patients – ER received noninvasive ischemic testing for CAD during the index – Heart Failure Clinic admission for Heart Failure.1 – Internal Medicine/Primary Care Office – General Cardiology

1. Doshi, D. et al. Underutilization of Coronary Artery Disease Testing Among Patients Hospitalized with New-Onset Heart Failure. Journal of The American College of Cardiology. 2016; 16, 68(5):450-458. Doshi D et al; JACC 2016;68:450-8 Patient Flow Chart MarketScan Commercial and Medicare Supplemental Databases (1/1/2010-12/31/2013)

N=81,526,366

New Heart Failure Diagnosis (Principle Diagnosis on an IP Claim)

N=98,264

Patients with Continuous Medical and Pharmacy Coverage At Least 12 Months Before Index Date

N=79,057

With 90 Day Post-Index Continuous Follow-up

N=67,161

No Known Baseline CAD CAD N=31,110 N=35,051 Rates of Invasive / Non-invasive Work-up for CAD in 67,640 Patients with New HF as Principal Diagnosis MarketScan Commercial and Medicare Supplemental Databases (1/1/2010-7/31/2014)

Doshi et al, JACC 2016 No CAD CAD All Patients p value

Total Patients 31,110 35,051 67,161

With Revascularization During 146 (0.5%) 1,230 (3.4%) 1,376 (2.1%) <0.001 Index Hospitalization PCI Only 119 (0.4%) 901 (2.5%) 1,017 (1.5%)

CABG only 30 (0.1%) 317 (0.9%) 347 (0.5%)

Hybrid 0 (0%) 12 (<0.1%) 12 (<0.1%) Without Revascularization 30,964 (99.5%) 33,821 (96.5%) 65,785 (98.0%) During Index Hospitalization

With Revascularization 635 (2.0%) 2,260 (6.3%) 2,895 (4.3%) <0.001 Within 90 Days PCI Only 406 (1.3%) 1,578 (4.4%) 1,984 (3.0%) CABG Only 225 (0.7%) 646 (1.8%) 871 (1.3%) Hybrid 4 (<0.1%) 36 (0.1%) 40 (0.1%) Without Revascularization 30,475 (97.8%) 32,791 (93.6%) 64,266 (95.7%) Within 90 Days Underuse of Revascularization 34,233 Patients with Heart Failure Preserved Ejection Fraction in Get with the Guidelines Heart Failure Program

Elevated Troponin Normal Troponin (n = 7,732) (n = 26,051) Age 80 79 Women 63% 68% CAD 47% 46% DM 42% 45% Prior MI 18% 14% Revascularization 0.8% 0.3%

Pandey et al, JAMA Cardiol. 2017;2:136-45 STICH: Revascularization Reduces Mortality

1.0

0.9 Hazard ratio 0.84 (95% CI 0.73-0.97) NNT=14 0.8 Log rank P=0.019

0.7

0.6 Medical therapy CABG 0.5

0.4 Mortality Rate Mortality 0.3

0.2

0.1 6.29 7.73 0.0 0 1 2 3 4 5 6 7 8 9 10 11

No. at risk Years Following Randomization Medical therapy 602 532 487 435 404 357 315 274 248 164 82 37 CABG 610 532 487 460 432 392 356 312 286 205 103 42

Velazquez EJ et al. N Engl J Med 2016 NSTEMI with LMCA/3VD: A Role for Medical Management? 41,310 pts from 316 high-volume hospitals in ACTION-GWTG

Harskamp et al, AHJ 2014; 167:355-362 Initial Goals of CHIP Initiative

• Raise awareness in the general and specialized cardiovascular community of this high-risk, underserved, population

Roles and Team Members Who May Be Called on in a Multidisciplinary Approach to Patients with Higher-risk, Severe CAD

Role Member Patient/family Shared decision making Patient and family members Physicians Defining goals of care and Primary care physician preprocedural optimization Primary cardiologist Advanced heart failure/critical care specialist (experience in advanced therapies, transplantation) Formulating Specialized coronary interventionalist revascularization strategy Cardiothoracic surgeon Multimodality imaging specialist Managing concomitant Structural heart interventionalist structural heart disease (for concomitant valvular disease) Managing concomitant Electrophysiologist rhythm therapies Postprocedural care Cardiac intensivist, primary cardiologist

Nurse or advanced practice provider to assist in Staff Care facilitation preprocedural/postprocedural optimization social worker/services

Kirtane et al, Circulation 2016;134:422-31 Technical Skills and Training/Infrastructure Requirements (for Physicians, Staff, and Institutions) for the Care and Revascularization of Patients with Higher-risk, Severe CAD

Patient/Lesion Subsets Techniques/Devices Patient/Lesion Subsets Techniques/Devices Chronic total occlusions Dual access and injections Poor hemodynamic Left/right ventricular percutaneously status/ventricular function implanted support devices Antegrade and retrograde coexisting with Intra-aortic balloon counterpulsation techniques, including dissection/ complex anatomy Extracorporeal membrane oxygenation re-entry devices Large-vessel access/closure Specialty wires, microcatheters, management devices for increasing guide/catheter Transradial expertise (when both support, externalization techniques femoral arteries are used) Alternative access considerations (axillary, transcaval) Stent underexpansion/ Intravascular imaging Left main stenosis/ Single- and 2-stent strategies restenosis Aggressive noncompliant and bifurcations (both primary and for plaquemodification balloons provisional/bailout use) Atherectomy (laser, rotational) Intravascular imaging Vascular brachytherapy Complication Echocardiography-guided Calcific disease Rotational/orbital atherectomy management pericardiocentesis Intravascular imaging Covered stents, coils, beads Multivessel disease Coronary physiological studies Snares/snaring techniques (e.g., fractional flow reserve) Dual guide techniques Intravascular imaging Dissection/re-entry to salvage distal flow Endovascular rescue

Kirtane et al, Circulation 2016;134:422-31 Initial Goals of CHIP Initiative

• Promote educational initiatives for enhanced cognitive and technical skills in the interventional cardiology community Training Initiatives

• CHIP fellowships encompassing HRPCI (including CTO), hemodynamic support:

 NY

 Seattle

 Detroit

 TBD… Columbia CHIP Fellows

Sanjog Kalra Raja Hatem Columbia CHIP Fellows

Darshan Doshi Sanjog Kalra Raja Hatem Initial Goals of CHIP Initiative

• Initiate disease and procedure based research to better define the treatment population access outcomes Research Priorities in the Higher-risk CAD Population Potentially Eligible for PCI

Research Priority/Question Study Design/Cohort What is the prevalence of severe Disease-based (as opposed (and nonrevascularized) CAD? to solely procedure-based) registries What are the outcomes of PCI in higher-risk CAD patients (e.g., nonsurgical patients), and are there specific Procedural registries operator/institution volumes that are required to achieve the best procedural outcomes? What are the costs associated with revascularization in Dedicated cost-effectiveness studies higher-risk CAD patients? within procedure- and disease-based registries What are the outcomes with PCI, surgical revascularization, and Disease-based registries with medical therapy among higher-risk patients with an indication embedded procedural data for revascularization? Potential randomized trials What is the variability in care patterns for patients Disease-based registries with meriting consideration of revascularization? embedded procedural data To what extent are contemporary interventionalists trained and Procedure- and disease-based skilled to perform complete revascularization across complex registries lesion subsets? Randomized trials, possible To what extent can PCI achieve comparative-effectiveness surgery-like outcomes in higher-risk CAD patients? assessments

Kirtane et al, Circulation 2016;134:422-31 National Co-PIs: Adam Salisbury, MD, MSc, David Kandzari, MD, J. Aaron Grantham, MD,

Steering Committee: Ajay Kirtane, MD, SM, William Lombardi, MD, William O’Neil, MD, Joseph Sabik, MD, Robert Yeh, MD, MBA

Angiographic Core Lab: Philippe Généreux, MD

Health Economics: David Cohen, MD, MSc Invited Centers

Mass General Hosp. Beth Israel Deaconess Mayo Clinic Cleveland Clinic Geisinger Medical Ctr Medical Centers University of Washington Rochester, MN University Hospitals Danville, PA Boston, MA Medical Center Cleveland, Ohio Seattle, WA UPMC Mt Sinai Medical Pittsburg, PA Center NY, NY Columbia University Medical Center Stanford Hospitals NY, NY and Clinics Palo Alto, CA MedStar Cardiovascular Research Institute Washington, D.C. Cedars‐Sinai UVA University Medical Center Hospital Los Angeles, CA Charlottesville, VA University of Kansas Hospital Wake Forrest Scripps Clinic Kansas City, KS La Jolla, CA Baptist Medical Piedmont Heart Saint Luke’s Mid Washington University/ Center Institute America Heart Institute Barnes Jewish Hospital Winston‐Salem, NC Kansas City, MO St. Louis, MO Atlanta, GA Initial Core Lab Adjudicated GDMT or Completeness of Index ± Revascularization GDMT Staged PCI • Anatomic, functional Alone • Complete N= 200 revascularization • “Jeopardy” score Percutaneous accounting for prior Intervention CABG n=600

1, 6 and 12-month Health Status • Seattle Angina Questionnaire • Kansas City Cardiomyopathy • Describe anticipated Questionnaire-12 benefits/risks • Rose Dyspnea Scale • Describe relationships • Veterans Rand-12 between management strategy and outcomes 1-Year MACCE Events • Inform future trials 5-year Mortality ECLIPSE Evaluation of Treatment Strategies for Severe CaLcifIc Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Prior to Implantation of Drug Eluting StEnts ~2000 pts with severely calcified lesions; ~60 US sites Randomize Orbital Atherectomy Strategy 1:1 Conventional Angioplasty Strategy (1.25 mm Crown followed by non- (conventional and/or specialty compliant balloon optimization) balloons per operator discretion)

2nd generation DES implantation 2nd generation DES implantation and optimization and optimization

1° endpoints: 1) Post-PCI in-stent MSA (N~400 in imaging study) 2) 1-year TVF (all patients) 2° endpoint: Procedural Success (stent deployed w/RS<20% & no maj complications) Principal investigators: Ajay J. Kirtane, Philippe Généreux; Study chairman: Gregg W. Stone Sponsor: Cardiovascular Systems Inc. ILUMIEN IV PI : Ziad Ali MD

Angiography Primary Endpoint: Post-PCI MSA assessed by OCT in each ≈ 2500 patients with high-risk clinical or lesion Identification of randomized arm characteristics study lesion 125 sites in North America, Western Europe and Asia-Pacific 1-year rate of target vessel failure (cardiac death, MI or ischemia-driven target vessel revascularization) Randomization to OCT-, or angiography- guided PCI

Pre-PCI OCT Inclusion Angiography • High-risk clinical characteristics • Medically treated DM

OCT Stent Sizing Guidance, • High-risk target lesion Angiography guided PCI, per study protocol • STE-ACS per “local standard practice” • NSTE-ACS (Tn >1ng/dl or Tn +ve with 1mm EKG ST deviation) OCT guided Optimization per Angiographic optimization, study protocol • Long or multiple lesions per “local standard (stent length >28mm) practice” • Bifurcation with 2 planned stents • Angiographic severe Ca2+ Post-PCI OCT • CTO (crossed and pre-dilated) Post-PCI OCT, • In-stent restenosis blinded to investigator

Procedure Complete

Minimum 1-year, Maximum 2-year follow-up The cVAD Registry

Steering Committee

Theodore Schreiber FDA Liaison Brij Maini Board of Directors Simon Dixon Magnus Ohman William O’Neill (Chairman) Jacob Møller George Vetrovec Jeffrey Moses Shelley Hall Mark Anderson Andreas Schafer William Lombardi

Abiomed ELECTRONIC DATA CAPTURING DATA MANAGEMENT Global cVAD REGISTRY DATA MONITORING 61 RESEARCH SITES

INTELEMAGE Image Transfer

INDEPENDENT CENTRAL CLINICAL IMAGING INSTITUTIONAL EVENTS CORELAB REVIEW COMMITTEE BOARD (IRB) (CEC)

The Global cVAD Registry is Sponsored by Abiomed, Inc. Development of the cVAD Registry

2017

2016

cVAD insourced, passed 2015 BIMO Audit in July

cVAD Registry Version6 2012 (Prospective)

2011 cVAD Registry Version5 (Impella RP®; structural heart, heart 2009 failure modules, EP)

USpella Registry Version4 (Impella CP®) 2009 USpella Registry Version3 (Introduced EDC)

USpella Registry Version2 (Abiomed sponsored: Impella 2.5™, Impella 5.0™; HRPCI, Surgery

USpella Registry Version1 (Investigator Initiated) Impella Pre-PCI Associated with Improved Survival in AMI/CGS

IQ Database1 cVAD Registry2 65% 59%

52% 41% P<0.001 P<0.003

N=3121 N=2450 N=91 N=63

IABP/Inotropes Pre-PCI Impella Pre-PCI IABP/ Inotropes Pre-PCI Impella Pre-PCI

1. Abiomed Impella Quality (IQ) Database, US AMI/CGS Apr 2009– Jan 2017. Survival to device explant. Danvers, MA: Abiomed. 2. O’Neill et al., J Int Cardiol 2014;27:1-11. Survival to hospital discharge Detroit CGS Initiative

Outcomes

89% 84% 100% Native 51% Heart Recovery In surviving Patients (31/31)

Survival to Explant 1 Survival to Explant2 Survival to Discharge 2 Metro Detroit… Detroit CSI Detroit CSI

1. Abiomed Impella Quality (IQ) Database , Jan 2015 to July 2016 for Aggregate DTW Metro Hospitals AMI/CGS Survival to Explant 2. Feasibility of Early Mechanical Support During Mechanical Reperfusion of Acute Myocardial Infarct Cardiogenic Shock; W. O’Neill, M. Basir, S. Dixon, K Patel, T Schreiber, S. Almany; In Press JACC Interventions Marrying Operators to Centers of Excellence Cath lab management, cost IVUS, OCT, effectiveness, NHPR and FFR data in support interpretation of and decision- Revascularization revascularization making Data and PCI Angjogram Intracoronary Metrics Complex anatomy, analysis, Physiology Multivessel PCI and bifurcation and Imaging Calcium Mgt techniques, Dual catheter atherectomy angiography, CTO types, guide toolbox, antegrade, support ADR and retrograde management crossing techniques It’s TimeComplex for andTraining StandardsHigh-Risk PCI Large Bore CTO PCI Access Management

Right heart Hemodynamics Complication Closure device hemodynamic and Ventricular Management management, analysis, MCS large bore radial implantation and Support access, femoral management, cross-over Call for help waveform analysis technique algorithm, coil and bead deployment, critical care, pericardiocentesis Taking a Page Out of the Trauma Book…

• Trauma centers organized by “Levels” • Each Level implies availability of additional services and expertise • Levels of care aim to improve outcomes by:

 Streamlining care based on patient need

 Optimizing resource availability, utilization

 Ensuring adequate case volume to maintain clinical expertise • Designation versus Verification

 Centers self define based on stated criteria with verification of all necessary features by centralized body The Future: Proposed Core Competency and Targets within Each Area

Coronary Complex PCI Physiology (Complex CHIP CHIP Population and Advanced Hemodynamics Anatomy, Training and Intravascular and Ventricular Multivessel PCI, Complication Large Bore Access Level Revascularization Imaging Support Atherectomy) CTO PCI Management Management  Basic FFR and IFR  RHC interpretation • Recognizing complex • Assessment of cutoffs and landmark • Complex and higher risk  Recognition of shock coronary anatomy and benefits and risks of • Basic algorithms for Pre-CHIP trials patient identification and and high-risk PCI angiographic calcification CTO PCI hypotension and  Normal vessel (Level 0) characteristics requiring hemodynamic • Basic 2 stent bifurcation • Dual catheter perforations appearance on IVUS support techniques angiography and OCT • Right heart hemodynamic analyses • Detailed angiogram • Complication recognition • Mechanics of in more complex analysis • “Call for help” algorithm FFR/IFR/RFR with substrates (e.g. right • Guide support and complication toolbox pressure pullback • CTO toolbox basics • Data supporting complete hear failure) management familiarity • Closure device management CHIP • Abnormal IVUS and • AWE and ADR revascularization • Basic MCS implantation • Complex bifurcation • Post PCI “no-flow” • Femoral access up to 14F OCT image • Vein graft and septal Competent • Costs and logistics of a and bedside techniques management • Radial access up to 7F interpretation conduit retrograde (Level 1) complex PCI management (e.g. • Rotational/ orbital/laser • Coronary perforation • Femoral cross over • Utilization of advanced CTO PCI Position, device flow, Atherectomy management (covered physiology (e.g CFR waveform analysis) • Left main PCI (data and stents, emergency and IMR) • Basic ECMO techniques) pericardio-centesis implantation • Physiologic • Shock team Advanced assessment of development and complex lesion management • CTO wire • Recognition of current CHIP subsets (e.g. tandem • Biventricular shock engineering • Full level of access knowledge gaps (e.g. CHIP • Collateral perforation lesions) recognition • Advanced ADR management including distal case outcomes, MCS management (beads, • Complex IVUS and • Advanced RV support • Ultra-low contrast PCI, (calcified/ diseased perfusion cannulae (Level 2) weaning protocols, etc) thrombin and fat injection) OCT analysis (e.g. hemodynamics • Enhanced atherectomy vessels) • Percutaneous axillary large • Conceptualization and • Managing equipment Stent fracture, • Bi-Ventricular support techniques (e.g. laser) • Full hybrid algorithm bore access techniques maintenance of institutional entrapment or loss dissections, etc) and venting indications, • Last remaining vessel CTO PCI including alternative access CHIP outcomes registry • Ongoing complication • Chromaflow, virtual implantation and intervention • “Algorithm-within- strategies (e.g. radial 8 • Participation in national management histology, imaging- management, familiarity the-algorithm” French, transcaval access for CHIP outcomes and other development guided bifurcation with Hemodynamic trouble- shooting MCS, etc) key databases techniques modeling (e.g. Harvi techniques • Imaging for minimal app), trans-septal MCS contrast PCI implantation

Kalra S et al. 2020 Under Review Operator and Institutional Requirements and Proposed Case Volume Targets for CHIP Centers Stratified by Level CHIP Center Level Operator Requirements Institutional Requirements • CTO skills: Full antegrade and • CHIP Community education team with retrograde (including epicardial) dedicated outreach and education • Atherectomy including enhanced laser events and high-risk rotational or orbital • Network of CHIP clinics with referral • Complex PCI: bifurcations, MVD, pathway and full document/electronic CHIP Level 1 Center atypical anatomy, congenital PCI, health record sharing capabilities “Never Need To Transfer Center” ultralow-contrast PCI • Multidisciplinary shock team • Full breadth of Hemodynamic support • Critical Care and HF physicians on team including right and left-sided pVAD • Advanced Surgical capabilities including devices as well as modifications (e.g. Tandem Heart and VAD and BT-VAD VAV ECMO) • Heart Transplant capable • CTO skills: antegrade and retrograde (non-epicardial) • CHIP Intake clinic with CHIP • Atherectomy including laser and either coordinator/patient educator rotational or orbital • CHIP Clinic number/access line • Complex PCI: unprotected left main, • Multidisciplinary shock team CHIP Level Two Center bifurcations, MVD, atypical anatomy, • Critical Care physician on team congenital PCI with MCS • Advanced Surgical capabilities • Full breadth of Hemodynamic support including, Tandem Heart, DT-VAD and including right and left-sided pVAD BT-VAD implantation devices • CTO skills: antegrade • Atherectomy (any) • Multidisciplinary shock team • Complex PCI: simple bifurcations, MVD • Critical Care physician on team CHIP Level Three Center without MCS • Advanced Surgical capabilities including • Hemodynamic support including pVAD temporary VAD support and ECMO Kalra S et al. 2020 Under Review Example On-the-Job Training Pathway

Tr aining In terested Lab Director Web Portal Ti me IC LOR Participation CH I P L evel 2 and M eeting Tr ainee Attendance Pre-CHIP Tr ainee

Advanced/ Complete MastersCourse Online Meeting Portal KnowledgeQuiz Registr ati on Attendance •WebPortal •Trainee Database CH I P L evel 2 • CHIP Passport Certification

Submit Casefor Onsite Formal Review Proctoringwith CoreWeb by CHIP Faculty CHIP Faculty Curriculum

CH IP Le vel 1 CH I P L evel 1 CHIP Level 2 Tr ainee Certification Certification Exam and Live Video Case Review by CHIP Faculty Possible Exit Possible Exit

Kalra S et al. 2020 Under Review Key Components and Services of Verified Centers of Excellence Full Service Support with Integrated team

Heart CT Surgery Failure

Interventional Cardiology Mid‐level and Staff Support

Vascular Techniqu Critical Care Shock Team Surgery e Roles and Team Members Who May Be Called on in a Multidisciplinary Approach to Patients with Higher-risk, Severe CAD

Nurse or advanced practice provider to assist in Staff Care facilitation preprocedural/postprocedural optimization social worker/services

Kirtane et al, Circulation 2016;134:422-31 Sophisticated Understanding of Hemodynamics and Support

• Putting in an Impella is not sufficient • Right heart hemodynamics to decide on an optimal support ; “canary in the coal mine” • Review systemic pressure, reserve, CPO etc. Hemodynamic Signature of RVF after LV Support

100 CP Activated

50 PA

RV Overload and 0 Tricuspid Regurgitation BiPella (CP + RP) Hemodynamics

100

RP Activated

0 The A is the PV Loop of an Impella protected myocardium, which allows physicians to do a safer, more effective and complete revascularization. CAMP PCI Continuous Learning

Online education with “essentials” to

Uploadable cines & consulting “masters”, self-assessment, potential services for how to do PCI (Pilot) CME | CEU | MOC offerings and password protected user groups with Q&A

Large teach-the-teacher Advanced individualized nationally based virtual, hospital training didactic, hands-on meetings (proctorships or virtual and focused on providing the proctorships) for qualified foundation for innovation, physicians training and education

Simulation based learning with virtual Centers of Excellence hospital-based and hands-on workshops, programs, for physicians to observe complication management and case techniques, skills and approach examples CAMP PCI Learning Objectives

• CAMP PCI: Coronary Artery & Myocardial Protected PCI  Improving patient outcomes and quality of life with supported high-risk PCI

• Curricula designed to enhance physician education on:  Patient Selection • Identify appropriate patients undergoing PCI that are complex, high-risk and at risk of AKI and other complications • Surgically ineligible patients • Publication analysis and summary clinical data for HRPCI  PCI Best Treatment Practices • Bifurcations, MVD, SVG’s, UPLM, CTO’s, Last Remaining Conduit • Complication Management and Bleeding Prevention • Anticoagulation and Pharmacology  Optimizing PCI: Advanced Tools & Techniques • Large Bore Access, Management & Closure, Imaging & Physiology, Atherectomy/Vessel Prep, Hemodynamic Assessment & Monitoring • Science of Unloading with Hemodynamic Support and Myocardial Protection and Weaning  Program Growth & Sustainability • Program Development, Protocol Implementation, Health Economics, Leadership/Advocacy Curricula: Online, Hands-On & Hospital Based

On-Site Advanced Training Hospital (Proctoring/Telemedicine Proctoring) Based Observership at Centers of Excellence

Masters Level for Supported HRPCI Hands-On Workshops Advanced Approach to Treating Supported High-Risk PCI Patients

Masters Level for Supported High-Risk PCI Online Educational Advanced Approach to Treating Supported High-Risk PCI Patients Modules Essential Best Practices, Techniques & Tools of Supported High-Risk PCI CAMP PCI Online Educational Content

Topics to include Masters:  IVUS After completing Essentials &  Atherectomy Advanced, additional on-line  IVL education on treating these  Alternate access complex and high-risk  Viability testing patients  Patient Preference  Algorithm development Topics to include: Advanced:  PCI Best Treatment Practices Online modules with a focus  Bifurcations, MVD, SVG’s, UPLM, CTO’s, Last Remaining Conduit on managing complications  Complication Management & Bleeding Prevention  Anticoagulation and Pharmacology when treating both complex  Optimizing PCI: Advanced Tools & Techniques and high-risk patient  Large Bore Access, Management & Closure, Imaging & Physiology, Atherectomy/Vessel Prep, populations through case- Hemodynamic Assessment & Monitoring based reviews  Science of Unloading with Hemodynamic Support and Myocardial Protection  Escalation and weaning with SmartAssist Topics to include:  Fundamentals of Hemodynamic Support/TEACH tutorial and Hemodynamic Assessment  Growing Patient Population: Patient selection appropriate for Protected PCI, Essentials:  Protected PCI Algorithm development and implementation Online educational track  Publication analysis and summary clinical data for HRPCI focused on providing the  AKI primer foundation of Supported  Access & Closure primer and patient management HRPCI  Techniques for treating complex lesion subsets such as UPLM, Bifurcation lesions, MVD  Tools  Building a Protected PCI Program  Protected PCI Economics (CE and reimbursement) CAMP Solutions to Physician Training Gaps Training & Curricula Current Instructor Led Courses Exclusive Impella user community Hands-on Workshops Annual physician meeting for faculty & educators Observerships Online educational modules & track Advanced Individualized Training Large bore access & closure | Alternative techniques Science of Hemodynamics Training & education on new products & innovation (TEACH) CME | MOC credits (pending) Password protected web-based user communities Interactive access to faculty & presentations Case of the week Case simulation Digital case consultation (pilot) New monthly content with Q&A Young et al. J Am Heart Assoc. 2020;9:e014738. DOI: 10.1161 Heart Team Recommendations STS / SYNTAX Score

STS Score SYNTAX Score

OMT PCI CABG OMT PCI CABG 70.0% 60.0% 63.0% 47.5% 60.0% 54.5% 50.0% 46.5% 47.9% 42.5% 41.9% 50.0% 40.0% 40.8% 34.9% 40.0% 32.2% 30.3% 30.0% 25.8% 30.0% 18.6% 18.5% 18.5% 20.0% 20.0% 15.2% 11.3% 10.0% 10.0% 10.0% 0.0% 0.0% <4% 4%-8% >8% ≤22% 23-32 ≥33 Final Treatment Recommendation (%)

Young et al. J Am Heart Assoc. 2020;9:e014738. DOI: 10.1161 Final Thoughts

• Our cath lab population is growing in complexity and risk • Paradoxically these very patients have the greatest potential benefit in improved outcomes compared to the usual “cohort” • It behooves every operator to be aware of current PCI capabilities and have access to them • As a community we must educate our colleagues and patients about these facts as well