Thomas wharton


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  • We agree with Ryan: not every interventionalist and not every hospital should do PCI.
  • We agree with Ryan: not every interventionalist and not every hospital should do PCI.
  • We agree with Ryan: not every interventionalist and not every hospital should do PCI.
  • We agree with Ryan: not every interventionalist and not every hospital should do PCI.
  • Thomas wharton

    1. 1. Off Site PCI Expert Panel Review Primary PCI – Development and Outcomes of a New Paradigm of Care Thomas Wharton MD FACC FSCAI Exeter Hospital, Exeter, NH TPWharton
    2. 2. Limitations of Thrombolytic Agents Failure rate: 46% of patients receiving lytics are not reperfused well enough to improve survival (GUSTO). Recurrent Events: In 20% to 40% of patients. Strokes: In 1.4% to 6.3%. Contraindications: Only 25% to 33% of patients with acute M.I. may be eligible for thrombolytic therapy. Frequent Need for Subsequent Procedures: Cath, PTCA Are Given “Blindly”: Some patients will be treated unnecessarily, because they have either spontaneously reperfused or been mis-diagnosed. A few of these patients will bleed into the head. TPWharton
    3. 3. PAMI-1 STUDYPAMI-1 STUDY 395 randomized lytic eligible pts with AMI : As compared with t-PA therapy for acute myocardial infarction, immediate PTCA reduced the combined occurrence of nonfatal reinfarction or death, was associated with a lower rate of intracranial hemorrhage, and resulted in similar left ventricular systolic function. NEJM 1993 NEJM 1993
    4. 4. 90-Minute Coronary Patency: PAMI vs GUSTO FLOW GRADE PTCA (PAMI) tPA (GUSTO) TIMI 0-1 (no flow) 6% 19% TIMI 2 (slow flow) -- 27% TIMI 3 (brisk flow) 94% 54% TPWharton
    5. 5. National Registry of Myocardial Infarction (NRMI)  Only 35% of 241,000 AMI pts were treated with lytics.  These lytic patients frequently needed other procedures:  70.7% underwent cath later before discharge  30.3% “ PTCA  13.3% “ CABG LYTICS (35%) NO LYTICS (65%) Mortality 5.9% 13.0% Major bleeding 2.8% 0.5% TPWharton
    6. 6. Primary PCI is Superior to Thrombolytic Therapy for Acute M.I. Pooled data from 10 randomized trials (n=2,606): Primary PTCA tPA pvalue Mortality 4.4 % 6.5 % 0.02 Death or Reinfarction 7.2 % 11.9 %<0.001 Total Stroke 0.7 % 2.0 %0.007 Weaver, JAMA 1997;278:2093 Hemorrhagic Stroke 0.1 % 1.1 % TPWharton
    7. 7. Primary PCI is Superior to Thrombolytic Therapy for Acute M.I.Brand new pooled data from 21 randomized trials (n=7,739): Primary PCI Lytic Rx p value Mortality 6.9 % 9.3 % 0.0002 Reinfarction 2.4 % 6.8% <0.0001 Total Stroke 1.0 % 2.0 % 0.0004 Hemorrhagic Stroke 0.05 % 1.1 % <0.0001 Combined 8.2 14.3 <0.0001 Keeley, Lancet 2003;361:13-20 TPWharton
    8. 8. Broader Applicability of Primary PCI Primary PTCA is arguably clinically superior to lytic therapy in lytic-eligible patients.* *Weaver, WD, JAMA 1997;278:2093 But even if the therapies were equal, a majority of AMI patients are not candidates for lytic therapy, due to  bleeding contraindications,  shock,  late presentation,  prior bypass surgery,  non-diagnostic EKG’s **Rogers WJ, AJM 1995;99:195 This group is higher-risk than lytic-eligible patients. These patients need an alternative to "morphine and bed rest." TPWharton
    9. 9. Primary PCI vs. Other Treatments in PatientsIneligible for Lytic Therapy (MITRA Registry) PTCA Conservative or Fibrinolytic Therapy High Bleeding Non-Diagnostic EKG, 50% Risk (n=337) 50% LBBB, Late Presentation (n=737) 42.3% % of Patients Mortality (%) 24.7% 24.1% 16.4% 8.2% 2.2% 0% 0% PTCA Conservative Mortality Combined Endpoint* Therapy PTCA Lytic PTCA Lytic *death, acute MI, stroke, CHF, angina Zahn, Catheter Cardiovasc Interv 1999;46:127 Zahn, Z Kardiol 1999;88:418 TPWharton
    10. 10. Primary PCI in Lytic Eligible Pts that are High Risk (MITRA Registry)High Risk Patients: Age >70, Anterior M.I., Heart Rate > 100 16 PCI Lytics 15.6% 12 9.8%(%) 8 6.7% 4 3.6% 4.1% 3.2% 1.4% 0.5% 0 Death Reinfarction Death or Stroke Re-MI O’Neill, J Invasive Cardiol 1998:10 Suppl A:4A-10A TPWharton
    11. 11. New Data From MITRA and MIR German Registries Pooled “real world” outcomes of nearly 10,000 AMI patients in 2 German Registries, 1994-1998: Primary PCI ThrombolysisMortality 6.4% 11.3% Primary angioplasty was associated with lower mortality in all subgroups both high- andodds ratio 0.54,including pts >75 y.o. 0.67 low-risk, 95% confidence interval 0.43 to As the mortality risk of the subgroup increased, the relative benefit of primary PCI increased. Zahn, JACC 2001;37:1827 TPWharton
    12. 12. Advantages of Primary PCI Can be used in virtually all infarct patients. Produces TIMI-3 flow over 90% of the time, not 54%. Does not cause intracranial bleeding. Reduces need for subsequent procedures (cath, PCI). Provides important angiographic information: patients who need urgent surgery can be detected early. Opens vessels as fast or faster. Can improve prognosis in cardiogenic shock. Yields a five-fold reduction in mortality in high-risk STEMI pts compared to thrombolytics. TPWharton
    13. 13. Profiles of NRMI Registry Hospitals Medical School Affiliation27.6% Cardiac Surgery37.6% Cardiac Catheterization Laboratory Rogers WJ, Circulation 1994;90:210361.3% TPWharton
    14. 14. DANAMI – 2 Trial: Primary PCI vs. Lytics at Hospitals With and Without PCI PCI On Site or After Transfer Thrombolytic Therapy 14.2% 15% 13.7% 12.3%Primary Endpoint (%) (death, MI, CVA) 10% 8.5% 8.0% 6.7% 5% 0% All Patients Presenting to Presenting to Angioplasty Community Centers Hospitals (n = 1,572) (n = 442) (n = 1,129) Andersen, ACC 2002 Presentation TPWharton
    15. 15. Prague – 2 TrialPRAGUE-2 Trial (Europe): Prospective randomization of 850 pts to lytic therapy on-site vs. emergency transfer for primary PCI •Thrombolytic Therapy (n = 421) Transfer for PCI (n = 429) 15.2% 30-Day Mortality (%) Death / MI / CVA (%) 10.4% 10% 10% 8.4% 6.0% 0% 0% Immediate transport of all STEMI patients for PCI is now part of the national guidelines of the Czech Republic. Widimsky, European Society of Cardiology, September, 2002 TPWharton
    16. 16. DANAMI-2 and PRAGUE-2 The DANAMI-2 and PRAGUE-2 studies established primary PCI as the treatment of choice for all patients presenting with acute STEMI, regardless of where they initially present. All such patients at hospitals without PCI should be transferred immediately directly into the cath lab of a PCI center, ideally with an “indoor-outdoor” time of <30 minutes. TPWharton
    17. 17. Delay and Mortality of Primary PCI After T ransfer: PTCA On Site (n=9,311) PTCA After Transfer (n=1,307) 6.0h 6.0 10% 7.7% 3.7h Time (hours) Mortality (%) 4.0 5.0% 5% 2.0 0.0 0% Time From Death AMI Onset to PTCA (In-Hospital)Transfer of acute MI patients to a surgical institution involves risk and delay, and is associated with worse outcomes than PCI on site. Tiefenbrunn, Circulation 1997:96:I-531 TPWharton
    18. 18. Guidelines Evolve as Medical Care EvolvesFrom the 1988 PCI Guidelines re Surgical Backup for PCI: “An experienced cardiovascular surgical team should be available within the institution for all angioplasty procedures,” and “there should be no exception to this requirement.” “All arrangements requiring transportation of patients to off-site surgical facilities fail to meet the necessary standards of care exercised by prudent physicians and cannot be condoned.” TPWharton
    19. 19. Off Site PCI Expert Panel Review without onsite surgery Primary PCI – ^ Development and Outcomes n even newer of a New Paradigm of Care ! a Thomas Wharton MD FACC FSCAI Exeter Hospital, Exeter, NH TPWharton
    20. 20. Primary Angioplasty for the Treatment of Acute Myocardial Infarction: Experience at Two Community Hospitals Without Cardiac Surgery Thomas P. Wharton, Jr., MD, FACC, Nancy Sinclair McNamara, RN, BSN, Frank A. Fedele, MD, FACC, Mark I. Jacobs, MD, FACC, Alan R. Gladstone, MD, Erik Funk, MD, FACC Exeter and Portsmouth, New Hampshire 506 consecutive pts:  “Primary angioplasty in patients with AMI can be performed safely and effectively in community hospitals without on-site cardiac surgery when rigorous program criteria are established.”JACC April, 1999 JACC April, 1999
    21. 21. 2001 ACC/AHA Guidelines for Off-Site PCI The 2001 ACC/AHA guidelines designated primary PCI at hospitals with off-site cardiac surgery as Class IIb: “Usefulness/efficacy is less well established by evidence/opinion,” provided that:  > 36 procedures/yr are performed at such hospitals,  by higher-volume operators (>75 procedures/yr),  within 90 ± 30 min of admission,  with a proven plan for rapid access to a cardiac surgical center.JACC 2001;37:2215 TPWharton
    22. 22. ACC/AHA 2001 PCI Guidelines ACC/AHA 2001 PCI Guidelines TPWharton
    23. 23. 2001 ACC/AHA Guidelines for Off-Site PCI This Committee also designated non-emergent PCI as Class III: stated that their Class III: “Not useful/effective, and in some cases may be harmful.” This classification was based on “consensus opinion of experts,” thus was not evidence-based (Level of Evidence C). TPWharton
    24. 24. CRITICAL PATHWAY: PRIMARY PCI AT HOSPITALS WITH OFF-SITE CARDIAC SURGICAL BACKUP PRE-HOSPITAL: Suspected AMI. Exeter Hospital Diagnostic EMS paramedic level of care, aspirin, IV line, sublingual NTG, 12-lead ST elevation ©2005 Wharton, Sinclair ECG transmitted to ED, heparin. ED physician calls interventional No diagnostic ST Elevation cardiologist and cath team. EMERGENCY DEPARTMENT: AMI diagnosed. >30 minutes of uncontrolled ischemic pain with positive serum markers and/or ECG with >1mm of ST deviation or LBBB. Call interventional cardiologist and cath team. EMERGENCY DEPARTMENT TREATMENT: ASA (if not given by EMS), heparin or enoxaparin, IV beta blocker, nitropaste, morphine, second IV line. Consider platelet GP IIb/IIIa inhibitor, clopidogrel. Treat pain, CHF, shock, arrhythmias. EMERGENCY TRANSFER to interventional / surgical hospital. CATH LAB Activate Emergency Transfer Protocol No AVAILABLE? with "indoor-outdoor" ED time goal of 45 minutes. Consider IABP (at capable hospitals) if hemodynamically unstable. Yes Consent, transport to cath lab. CARDIAC CATH LAB: PRIMARY PCI Arterial sheath; venous sheath if unstable or heart of IRA only. block, IABP if in shock or hemodynamically unstable, pacer as needed. Coronary angiography. Yes No EMERGENCY CABG indicated DETERMINE with or without PCI: TIMI 3 FLOW REVASCULARIZATION CABG Activate Emergency Transfer IN IRA? STRATEGY Protocol. Primary PCI RISK STRATIFICATION*Medical AND MANAGEMENTtherapy PRIMARY PCI *Clinical and angiographic Not of IRA only. Monitor ACT, GP IIb/IIIa inhibitor. low risk: Age <70, 1-2 v low risk Left ventriculogram. Consider right heart disease, EF >45%, no CHF Low risk catheterization, IABP, pacer if unstable. or arrhythmias, good PCI result. Admit to interventional unit. Standard CCU care. Fast-track cardiac rehabilitation; Target discharge on MEDICAL THERAPY target discharge on hospital day hospital day 4-5, ASA, GP IIb/IIIa inhibitor, beta blocker, ACE inhibitor 3 without pre-discharge ETT. consider ETT. or ARB, statin, clopidogrel load and maintentance. Return to work at 2 weeks. Elective CABG if indicated. Smoking cessation,risk factor identification and modification, cardiac rehabilitation. DISCHARGE; cardiac rehab phase II; ETT and lipid profile at 4 wks.
    25. 25. Circulation November 2005 Circulation November 2005 T Wharton, Exeter Hospital
    26. 26. Primary PCI in 500 high-risk pts at 19 off-site hospitals was compared to pts transferred after presentation to non-PCI hospitals: “On-site PA and transfer groups had similar 30-day outcomes, and more rapid reperfusion for on-site PA.”JACC 2004 JACC 2004 TPWharton
    27. 27.  “The study by Wharton et al. is extremely relevant because currently there is great debate regarding the appropriateness of performing primary PCI at hospitals without on-site surgery. . .” “This study documents that superb outcomes can be achieved at hospitals that do not offer on-site cardiac surgery. . .” JACC 2004 JACC 2004 TPWharton
    28. 28.  “I believe the data presented by Wharton et al. provide sufficient evidence to revise these guidelines to provide a class IIa indication (weight of evidence/opinion is in favor of usefulness/efficacy) for primary PCI at hospitals with catheterization laboratories but without on-site surgery.” JACC 2004 JACC 2004 TPWharton
    29. 29. 2005 Guidelines for PCI Off-Site Nevertheless the 2005 Guidelines Committee maintained its Class IIb indication for Primary PCI at hospitals without on-site cardiac surgery. The 2005 Guidelines Committee also maintained its Class III indication for elective PCI at such hospitals, and unfortunately introduced new and very inflammatory language, arguably without valid justification, not citing a large amount of new literature: “Performing elective PCI in a setting without immediately available onsite cardiac surgery potentially compromises patient safety and is not recommended.” TPWharton
    30. 30. TPW Presentation on Guidelines at ACC 2006 “In view of the rapidly accumulating evidence of safety and efficacy, and no relevant evidence of harm reported to date (the JAMA Medicare claims-coding article notwithstanding), strong consideration should be given now to upgrading the Guidelines indication for non-emergent PCI from Class III to Class IIb at centers with off-site backup that can meet rigorous qualifications.” TPWharton
    31. 31. TPW Presentation on Guidelines at ACC 2006An audience member made the following observation at mypresentation at an ACC Guidelines session in 2006: “Since the Guidelines Writing Committee’s conclusions carry so much weight, and have such a powerful influence on 3rd party payors, state regulators, and litigation attorneys, the Writing Committee has a profound responsibility to fairly consider, fairly interpret, and rapidly update all of the available information in this vital and growing field.” TPWharton
    32. 32. Critical Pathways in Cardiology June 2005 Critical Pathways in Cardiology June 2005
    33. 33. 1 Gathered facts and trends on prevalence of PCI without on-site surgery 2 Reviewed existing guidelines worldwide on PCI without onsite surgery 3 Reviewed literature related to PCI without on-site surgery much more comprehensively than did the 2005 ACC/AHA Guidelines 4 Defined the best practice methods for PCI without on-site surgery 5 Made recommendations on the role of PCI without on-site surgeryCatheterization and Cardiovascular Interventions March, 2007 Catheterization and Cardiovascular Interventions March, 2007
    34. 34. Patient Selection Criteria – PRIMARY PCI Patient Selection Criteria for Angioplasty and Emergency Aortocoronary Bypass at Hospitals Without On-Site Cardiac Surgery Avoid intervention in hemodynamically stable patients with: • Significant (> 60%) stenosis of an unprotected Left Main (LM) coronary artery upstream from an acute occlusion in the left coronary system that might be disrupted by the angioplasty catheter • Extremely long or angulated infarct-related lesions with TIMI grade 3 flow • Infarct-related lesions with TIMI Grade 3 flow in stable patients with three vessel disease • Infarct-related lesions of small or secondary vessels • Lesions in other than the infarct artery Transfer for emergent aortocoronary bypass surgery patients with: • High-grade residual left main or multivessel coronary disease and clinical or hemodynamic instability o After angioplasty or occluded vessels o Preferably with intraaortic balloon pump support Table 16: American College of Cardiology/ American Heart Association Percutaneous Coronary Intervention Guidelines. Adapted with permission from Wharton TP Jr, McNamara NS, Fedele FA, Jacobs MI, Gladstone AR, Funk EJ. Primary angioplasty for the treatment of acute myocardial infarction: experience at two community hospitals without cardiac surgery. Journal of American College of Cardiology 1999; 33: 1257-65.Catheterization and Cardiovascular Interventions March, 2007 Catheterization and Cardiovascular Interventions March, 2007 TPWharton
    35. 35. Catheterization and Cardiovascular Interventions March, 2007 Catheterization and Cardiovascular Interventions March, 2007 TPWharton
    36. 36. Catheterization and Cardiovascular Interventions March, 2007 Catheterization and Cardiovascular Interventions March, 2007 TPWharton
    37. 37. Catheterization and Cardiovascular Interventions March, 2007 Catheterization and Cardiovascular Interventions March, 2007 TPWharton
    38. 38. Catheterization and Cardiovascular Interventions March, 2007 Catheterization and Cardiovascular Interventions March, 2007 TPWharton
    39. 39. TPWharton
    40. 40. Case Presentation• Two weeks before Hurricane Sandy this 59 y.o. lady lost her adult son tragically.• Two days after the son’s death, she collapsed at home.• Her husband, not knowing CPR, called 911 and ran to the neighbor’s house.• The neighbor ran over and started CPR.• EMS administered 3 shocks for ventricular fibrillation (VF), epinephrine boluses, performed intubation, and transmitted EKG to ED. TPWharton
    41. 41. Case Presentation TPWharton
    42. 42. Case Presentation• After 30 minutes in the field, a pulse was felt.• On arrival in the ED she was unresponsive, fixed pupils, with thready carotids and no peripheral pulse.• A countershock was required for recurrent VF.• The Arctic Sun therapeutic cooling system was applied in the E.D. TPWharton
    43. 43. Arctic Sun Therapeutic Cooling Device TPWharton
    44. 44. Arctic Sun Therapeutic Cooling Device TPWharton
    45. 45. Updated 2005 AHA Guidelines for CPR Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment. IIa. Weight of evidence/opinion is in favor of usefulness/efficacy. IIb. Usefulness/efficacy is less well established by evidence/opinion. Circulation 2005; 112:IV-206 – IV-211 TPWharton
    46. 46. Case Presentation• She was then taken to the Cath Lab, shocky and very acidotic, on 2 pressors and the cooling device.• On arrival at the cath lab she developed pulseless electrical activity (PEA).• The Lucas cardiac compression device was applied, with a radiolucent back plate to allow fluoroscopy. This produced an excellent pulse. TPWharton
    47. 47. LUCAS External Compression CPR TPWharton
    48. 48. LUCAS External Compression CPR TPWharton
    49. 49. Case Presentation• After bifemoral access we were able to use cranially-angluated fluoroscopy to position an intraaortic balloon while on the Lucas CPR device.• On the balloon pump and pressors, we were able to discontinue the Lucas CPR device.• Severe metabolic acidosis responded only poorly to aggressive treatment.• She remained unresponsive, pressor dependent. TPWharton
    50. 50. Case Presentation(Coronary angiography was shown which demonstrated a totally occluded proximal LAD artery with no antegrade flow and no collateralizaion, successfully recanalized with PCI/stenting.) TPWharton
    51. 51. Case Presentation• On reperfusion she developed incessant VF, requiring 7 countershocks, amiodarone boluses, empiric Mg++ and K+ IV.• She remained pressor and balloon pump dependent, acidotic, unresponsive, cardiac output 1.6 L/m, wedge pressure 30mmHg, no urine.• After 18 h and the addition of dobutamine, her hemodyamics began to improve.• After 24 hours she was re-warmed. TPWharton
    52. 52. Case Presentation TPWharton
    53. 53. Case Presentation TPWharton
    54. 54. Case Presentation• Pressors were weaned, IABP removed on day 3, extubated day 6.• Her echo EF had improved to 50-55% with minimal anterior wall hypokinesis.• By extubation on day 7 she was completely alert, very talkative.• One of the first things she said moments after extubation was that she had visited her deceased son; that he was “with God;” but God told her “get back home, I don’t want you yet.” TPWharton
    55. 55. Case Presentation TPWharton
    56. 56. Case Presentation• This extraordinary outcome demonstrates what a flawless “chain of survival” can accomplish, from EMS in the field, thru ED, thru respiratory and ICU nursing care.• In particular, this outcome would not have been possible without expert 24/7 PCI available nearby, at the point of first patient contact.• She is now home, enjoying Thanksgiving with her family, completely mentally intact and with excellent cardiac function. TPWharton
    57. 57. Case Presentation• The door-to-defibrillation-to-cooling-to- Lucas CPR-to-balloon pump time (D-2-D-2-C-2-L-2-IABP time) was 86 minutes.• The LAD coronary was opened in 18m more.• Her brain was very poorly perfused for about 2 hours.• Locally available immediate primary PCI meant the difference between life and death in this woman. TPWharton
    58. 58. Case Presentation• One of the cath lab staff observed after the procedure—and this was his own idea— “Ya know, Dr. Wharton, if we didn’t do so many stable elective patients in this lab, we wouldn’t have had the experience to be able to perform nearly so well in this case!” TPWharton
    59. 59. 2011 Guidelines for PCI Off-Site TPWharton
    60. 60. 2011 Guidelines for PCI Off-Site4.8. PCI in Hospitals Without On-Site SurgicalBackup: RecommendationsCLASS IIa1. Primary PCI is reasonable in hospitals without onsite cardiac surgery, providedthat appropriate planning for program development has been accomplished.CLASS IIb1. Elective PCI might be considered in hospitals without on-site cardiac surgery,provided that appropriate planning for program development has beenaccomplished and rigorous clinical and angiographic criteria are used for properpatient selection. Better Late than Never !! TPWharton
    61. 61. Corazon Materials Related to Economic Quality Impact ofAvoidance of Staged PCI Procedures © Corazon, Inc. All rights reserved.
    62. 62. PCI-Staged vs. Same Setting of Care Payor Cost Avoidance Scenario $7302 per case cost Sample based on 2010 Medicare avoidance $7+ Million cost avoidance with Statewide Sample•Hospital component for PCI based on CMS split of case volume across DRGs 246-251•Physician Pro-fee for dx cath based on CMS left heart cath & PCI blended payment rate based on 1.4 stents/case•Transport based on State ground rates + 10 miles & a blend of Advanced Life Support levels © Corazon, Inc. All rights reserved. © Corazon, Inc. All rights reserved. 64