Cohen MG - AIMRADIAL 2013 - Complex PCI

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Radial approach for PCI and femoral for LV support

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Cohen MG - AIMRADIAL 2013 - Complex PCI

  1. 1. Radial Approach for PCI Femoral Approach for LV Support Mauricio G. Cohen, MD Director, Cardiac Cath Lab Associate Professor of Medicine
  2. 2. History   —  75-­‐year-­‐old  gentleman     —  Hypertension   —  Diabetes   —  Non-­‐ST  elevation  myocardial  infarction   —  Cathed  and  treated  with  an  IABP  for  48-­‐72  hs   —  Ejection  fraction  15%,  severe  anterior  hypokinesis   —  Severe  MR,  RVSP  52  mmHg   —  Viability  anterior  wall  
  3. 3. Cath  @  VA  –  July  10  
  4. 4. Cath  @  VA  –  July  10  
  5. 5. Pa6ent  is  transferred  to  UMH   —  Hypotensive  –  somewhat  lethargic   —  Sepsis  with  positive  blood  cultures   —  Severe  Anemia   —  Patient  is  Jehovah's  witness.   —  Refuses  blood  transfusions   Albumin:  3.6     Total  Bilirubin:  1.5  (H)     Alkaline  Phosphatase:  103     ALT:  717  (H)     AST:906  (H)   —  After  a  week  of  antibiotics  and  fluid  resuscitation  the   patient  goes  back  to  VA   127      89            38             5.3            25            2.4   130   26.2   8.2   25.0   180  
  6. 6. Percutaneous Support Devices Desai N R , Bhatt D L Eur Heart J 2009;30:2073-2075
  7. 7. Comparison of Support Devices IABP TandemHeart Impella Catheter Size 7.5-9.0 21/17/15 9 Cannula Size 8.5-10 21/17/15 12 1 + 2 ++/+++ 1 + No Yes No Limb ischemia + +++ + Priming volume No Yes No Unloads Directly LV No No Yes Requires stable rhythm Improve hemodynamics Yes + No +++ No ++/+++ # Insertion Sites Anticoagulation Transeptal
  8. 8. Mostly Anecdotal Experience
  9. 9. Percutaneous Hemodynamic Support Devices I IIa IIb III I IIa IIb III Elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable in carefully selected high-risk patients. A hemodynamic support device is recommended for patients with cardiogenic shock after STEMI who do not quickly stabilize with pharmacologic therapy.
  10. 10. Defining High Risk PCI à 2 Dimensions < 19 EuroSCORE 0-2 3-6 >6 19-27 > 27 L L I L L I I I H GRC = The Global Risk Classification 96.1% 94.6% 90 80 78.1% P = 0.004* 70 LOW INTERMEDIATE HIGH 60 SYNTAX score 24 12 Time (months) 0 100 Cardiac death free survival (%) SYNTAX score Cardiac death free survival (%) 100 98.4% 90 84.0% 80 P < 0.001* 70 LOW INTERMEDIATE HIGH 60 0 * log rank test; n = 255 LM patients undergoing PCI Capodanno et al, Am Heart J 2010:159:103-9 12 Time (months) 68.6% GRC 24
  11. 11. Low EF is Associated with Severe Comorbidities and Poorer Outcomes NHLBI Registry N= 1458 Reported PCI cases EF≤40% (n=166) Age >65 yrs 54.5% Previous MI 70.3% Known Heart Failure 35.5% Multi-vessel disease 75.3% Any total occlusion 59.0% In-hospital Adverse Events Death 3.0% Death/MI 6.0% One-year Adverse Events Death 11.0% Death/MI 18.0% EF 41%-49% EF≥50% p-value (n=126) (n=866) 48.4% 60.0% 13.6% 65.9% 46.0% 42.8% 36.7% 5.1% 56.6% 28.6% 0.004 <0.001 <0.001 <0.001 <0.001 1.6% 5.6% 0.1% 2.9% <0.001 0.024 4.5% 9.6% 1.9% 6.9% <0.001 <0.001 Keelan and al , Am J Cardiol 2003; 91:1168-1172
  12. 12. High Risk PCI: Randomized Data BCIS Study PROTECT II Study Extensive CAD (Jeopardy Score ≥ 8) and LVEF ≤ 30% (N=301) Unprotected LM and LVEF≤ 35% Or 3 VD and LVEF ≤ 30% (N=448) R 1:1 R 1:1 Prophylactic Support: EQUIPOISE Prophylactic IABP Provisional IABP Prophylactic Support: REQUIRED IABP + PCI IMPELLA+ PCI MACCE @ Discharge 30 day Major Adverse Events 6 mo mortality F/U: 90 day Major Adverse Events
  13. 13. BCIS Study: Results Do Not Support Prophylactic Use of IABP MACCE at Discharge p=0.85 15.2%   16.0%   N= 151   N= 150   Elective IABP Not Planned IABP Perera et al. JAMA 2010 Aug 25;304(8):867-74
  14. 14. PROTECT II Study: Reduction of Major Adverse Events in Favor of IMPELLA Compared to IABP MACCE Events p=0.023 ↓ 22% MAE p=0.092 Death, Stroke, MI, Repeat revasc. IABP IMPELLA N=427, Log rank test, p=0.043 N=211 N=216 N=210 N=215 O’Neill W et al. Circulation 2012;126:1717-1727 MAE = Composite of 10 Major adverse events including Death, Stroke, MI, Repeat Revasc. MACCE= Death, Stroke, MI*, Repeat revasc. (*Stone et al, Circulation 2001;104:642-647 )
  15. 15. Hemodynamic Support Effectiveness Cardiac Power Output (Secondary Endpoint) Maximal Decrease in CPO on device Support from Baseline (in x0.01 Watts) IABP Impella N=138 N=141 - 4.2 ± 24 p=0.001 - 14.2 ± 27 CPO data available only for 279 patients (N=138 IABP and N=141 Impella) CPO= Cardiac Power Output = Cardiac Output x Mean Arterial Pressure x 0.0022 (Fincke R, Hochman J et al JACC 2004; 44:340-348)
  16. 16. PROTECT II: NYHA Improvement Post PCI p<0.001 Class IV 58% reduction Class III in Class III,IV Class II Class I Baseline 90 days NYHA Class Distribution N=223 patients with NHYA assessment available at baseline and 90 days
  17. 17. When Should We Consider Support? n  Unprotected LM/Last Patent Conduit n  3 Vessel Disease AND n  Severe LV dysfunction < 30-35% " support for ischemic stress and contrast load n  LV dysfunction with prospect of uncontrolled interruption of coronary flow " Difficult wiring " Difficult stent delivery " High risk of no reflow (i.e., SVGs, Roto)
  18. 18. Spectrum of Risk Clinical and Angiographic STS score SYNTAX score SYNTAX BCIS PROTECT II
  19. 19. CARDIOGENIC SHOCK
  20. 20. IABP Shock II Trial 790 Pts with AMI and Cardiogenic Shock 600 randomized IABP (n=301) Control (n=299) IABP = 288 No IABP = 13 No IABP = 269 IABP = 30 Primary PCI = 288 Primary CABG = 3 No Revasc = 8 Primary PCI = 287 Primary CABG = 3 No Revasc = 1 30-day Follow up Thiele H, et al. N Engl J Med 2012; 367:1287-1296
  21. 21. Primary Endpoint: 30-day Mortality Thiele H, et al. N Engl J Med 2012; 367:1287-1296
  22. 22. Hemodynamic Parameters: IABP vs. “Other Devices” Thiele: TandemHeart Burkhoff: TandemHeart Seyfarth: Impella Cheng J M et al. Eur Heart J 2009;30:2102-2108
  23. 23. Outcome: Survival to Discharge Post PCI Timing of Support Initiation 60.0% Survival to Discharge For ALL Patients p=0.007 64.6% 37.7% STEMI N=25 Pre-PCI N=61 Post-PCI Impella Support Initiation 69.6% 39.4% 50.0% NSTEMI N=48 Pre-PCI N=71 Post-PCI Impella Support Initiation N=23 Pre-PCI N=10 Post-PCI Impella Support Initiation
  24. 24. ACCESS RELATED ISSUES
  25. 25. Outcomes at “Femoral” and “Radial” Centers 70% Transradial 22% Transradial 519 PCI/Hosp/year 657 PCI/Hosp/year Adj Mortality of TFA in TRA hospital vs TFA hospital OR 0.86, 95% CI 0.76-0.99, p=0.032 Ratib, Routledge, Mamas, Ludman, Fraser and Nolan, AIM-Radial 2012
  26. 26. FAUST Trial: CFA Cannulation Success n=1,015 p = 0.15 p = 0.11 Fluoroscopy Ultrasound 33 (6.6) 0.25 CFA 408 (83.3) 431 (86.4) 0.15 Low stick 58 (11.8) 35 (7.0) <0.01 p <0.01 P-value 24 (4.9) p = 0.78 High stick Seto A et al. JACC Intv. 2010;3;751-758
  27. 27. Procedural Outcomes First Pass Success Rate Number of Attempts 100% 5 90% p < 0.000001 82.7% 80% 3 70% 60% 3 46.4% 50% 1.3 2 40% 30% 20% 1 10% 0 0% Fluoroscopy Fluoroscopy Ultrasound Risk of Venipuncture 20% Ultrasound Time to Sheath Insertion 300 15.8% 213 p = 0.016 185 15% p < 0.000001 10% 2.4% 5% 0% Seconds Attempts 4 p < 0.000001 200 100 0 Fluoroscopy Ultrasound Fluoroscopy Ultrasound Seto A et al. JACC Intv. 2010;3;751-758
  28. 28. Complications Fluoroscopy Ultrasound N=501 N=503 Hematoma >5 cm* 11 (2.2%) 3 (0.6%) 0.034 Pseudoaneurysm 0 1 NS Dissection 3 2 NS Access bleeding, transfusion 2 1 NS Hematoma, DVT 1 0 NS Complication Any complication 17 (3.4%) 7 (1.4%) P-value 0.041 *Blinded hematoma assessments: 8F, 0 US, p<0.01 Seto A et al. JACC Intv. 2010;3;751-758
  29. 29. Exit Strategy O’Neill BP et al , et al. CCI 2013
  30. 30. Bleeding according to Pre-Closure use 20% No Pre-Closure Pre-Closure 15.1% Patients (%) 15% 14.5% 11.3% 9.4% 10% 7.4% 5% 4.5% 5.6% 4.1% 0% VARC TIMI GUSTO BARC≥3 O’Neill BP et al , et al. CCI 2013, in press
  31. 31. Effect of Pre-Closure on Death, MI, and Acute Vascular Injury 20% Patients (%) No-Preclosure 15% Preclosure p=0.08 10% 5% P=0.12 p=0.04 10.1% 8.2% 4.1% 5.0% 4.8% 2.2% 0% Death MI Acute Vascular Injury O’Neill BP et al , et al. CCI 2013, in press
  32. 32. Strategy   Complex  transradial  bifurcation  PCI   Percutaneous  LVAD   Impella  2.5   Remove  at  the  end  of  the  case  
  33. 33. Radial PCI + Femoral LV support The Perfect Marriage n  Transradial access associated with lower vascular complication and bleeding risk " These complications ↑ mortality, especially in high risk patients n  Transradial operators are better “Femoralists” –  Ratib, Routledge, Mamas, Ludman, Fraser and Nolan n  Expand choices in patients with PVD and limited access options " Optimal and perfect femoral access –  Fluoro and U/S guidance n  Challenges in radial puncture in patients with shock " " LV support first, then radial access Ultrasound guidance

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