Training a Team of Skilled Operators
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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 80 60 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 Freedom from 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% 8% 6% 4% Cumulative Mortality 2% 0% 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 COURAGE: Rates of Death or MI by Residual Ischemia on 6-18m MPS p=0.002 p=0.023 p=0.063 Death or MI Rate (%) MI Death or 0% 1%-4.9% 5%-9.9% >10% (n=23) (n=141) (n=88) (n=62) Shaw LA et al. Circulation 2008;117:1283-91 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.