PRIMARY PCI WITHOUT ONSITE      CABG FACILITY      DEV PAHLAJANI MD,FACC,FSCAI  CHIEF OF INTERVENTIONAL CARDIOLOGY    BREA...
PCI WITHOUT ONSITE CABG           PRE STENT ERA• Gruntzig’s first 50 cases—10% needed  emergency CABG• NHLBI 1984—6.6% req...
EMERGENCY CABG POST PCI-            INDICATIONS•   Extensive dissection•   Acute closure•   Perforation, tamponade•   Majo...
Percentage of patients requiring emergency coronary artery bypassgrafting (CABG) after percutaneous coronary intervention ...
Prevalence of emergency CABG after percutaneous coronary interventions from 1992 through 2000                        2.0  ...
Prevalence of emergency CABG in Stented and   non-stented patients 1992 through 2000                       6              ...
Use of Stents and Platelet Glycoprotein IIb/IIIainhibitors in all patients from 1992 through 2000           100           ...
Predictors for Emergency Coronary Artery BypassGrafting During the Pre-Stent Era (1979 to 1994)                           ...
Predictors for Emergency Coronary Artery Bypass  Grafting During the Stent Era (1995 to 2003)                             ...
In-hospital mortality rates of patients requiring emergencycoronary artery bypass grafting after percutaneous coronary    ...
Time Dependency?
For every 30-minute delay from onset of symptoms to primaryPCI, there is an 8 percent increase in the relative risk of 1-y...
PAMI VS THROMB.META ANALYSISMeta-Analysis of 23 Randomized Trials of Percutaneous CoronaryIntervention (PCI) vs. Lysis (n=...
PPCI WITHOUT ONSITE CABG• HOW OFTEN IS THE NEED?• IS IT BETTER THAN FIBRINOLYTICS?• IS IT NON INFERIOR/BETTER THAN ONSITE ...
Most of the 1,506 hospitals in the National Registry of Myocardial Infarction-2 had   the capability to perform coronary a...
PAMI 2- Stone et al ,AJC 2000• 982 patients underwent PPCI• 6.1% needed CABG during index hospital• Only 0.4% of these CAB...
Randomized Trials of Primary Stenting Versus BalloonAngioplasty for Acute Myocardial Infarction : Incidence of            ...
PPCI WITHOUT ONSITE CABG• WHAT IS THE NEED?• IS IT BETTER THAN FIBRINOLYTICS?• IS IT SAFE/NON INFERIOR OR BETTER THAN AT  ...
Thrombolytic Therapy vs PrimaryPercutaneous Coronary Intervention for    Myocardial Infarction in PatientsPresenting to Ho...
Flow of Participants Through The Trial                C-PORT                          451                       Randomized...
Primary Outcomes : Treatment-Received               Analysis                                   No. (%)Outcome        Throm...
CPORTCumulative 6-Week Event-Free Survival                                                  1.0                 Cumulative...
PPCI WITHOUT ONSITE CABG• WHAT IS THE NEED?• IS IT BETTER THAN FIBRINOLYTICS?• IS IT SAFE/NON INFERIOR OR BETTER THAN  AT ...
Primary Angioplasty Without Cardiac Surgery In-Hospital Outcomes in Patients               Undergoing                     ...
Primary Angioplasty Without Cardiac                  Surgery                 124                 min                      ...
Outcomes of 335 Primary       Angioplasty ProceduresOutcome                             Mean Value ± SD                   ...
Time to Treatment in the                Air PAMI-No SOS Study      Time Intervals (min)            Transfer for PA    On-S...
Transfer for PA (n=71)                                                                       On-Site PA (n=499       20   ...
Percutaneous Coronary InterventionsIn Facilities Without Cardiac SurgeryOn Site : A Report From the NationalCardiovascular...
NCDR –JACC 2009• Data from jan 2004-march 2009• 308161 patients• 465 PCI capable centers• 8736 patients 60 centers with no...
Pie charts showing the relative distribution of myocardial infarction (Ml) presentation within       centers with on- or o...
Odds ratio plot of risk-adjusted outcomes, including sensitivity analysis for missing mortality data. Odds ratio: outcomes...
Physician Volume and Outcome of Primary PCI Average Mortality by Physician and Hospital                  VolumePhysician V...
Volume-Outcome Relationship                                      for Hospitals and Physicians                            1...
PPCI WITHOUT ONSITE CABG• WHAT IS THE NEED?• IS IT BETTER THAN FIBRINOLYTICS?• IS IT SAFE/NON INFERIOR OR BETTER THAN AT  ...
Points To Ensure1) The risks and benefits of primary PCI versus thrombolytic therapy;2) The risks and benefits of primary ...
2011 ACC/AHA/SCAI GUIDELINES     EXECUTIVE SUMMARY• CLASS IIA:LEVEL OF EVIDENCE B• PPCI is reasonable in hospital without ...
PPCI WITHOUT ONSITE CABG• CLASS III-HARM!!!• PPCI should not be performed in  hospital without a plan for rapid  transport...
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Primary PCI without onsite CABG facility

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Current PCI guidelines from the American Heart Association, American College of Cardiology, and Society for Cardiovascular Angiography and Interventions, published in 2006, said that performing elective PCI at centers with off-site surgical backup is "not recommended" (a class III category), and that primary PCI at these locations "may be considered" (a class IIb category) (J. Am. Coll. Cardiol. 2006;47:216-35). Favorable outcomes for primary PCI performed in facilities without cardiac surgery backup on site have been reported The new findings reported by Dr. Kutcher warrant upgrading both of these recommendations and designating both uses of PCI at centers with off-site backup as class IIa recommendations. Dr. Michael A. Kutcher performed a study using data collected by the NCDR CathPCI registry on consecutive cases done during Jan. 1, 2004, through March 30, 2006, with 308,161 patients treated at 465 U.S. centers. This included 9,029 patients treated with off-site surgical backup at 61 centers, and 299,132 patients treated at 404 centers with on-site surgical backup.

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Primary PCI without onsite CABG facility

  1. 1. PRIMARY PCI WITHOUT ONSITE CABG FACILITY DEV PAHLAJANI MD,FACC,FSCAI CHIEF OF INTERVENTIONAL CARDIOLOGY BREACH CANDY HOSPITAL, MUMBAI
  2. 2. PCI WITHOUT ONSITE CABG PRE STENT ERA• Gruntzig’s first 50 cases—10% needed emergency CABG• NHLBI 1984—6.6% required emergency cabg• Dropped to 3% in late 90’s
  3. 3. EMERGENCY CABG POST PCI- INDICATIONS• Extensive dissection• Acute closure• Perforation, tamponade• Major side branch occlusion• Unsuccessful dilatation
  4. 4. Percentage of patients requiring emergency coronary artery bypassgrafting (CABG) after percutaneous coronary intervention from 1979 to 2003 (n = 23,087). 14 p < 0.001 for trend 12 % Emergency of CABG 10 8 6 4 2 0 1979 1984 1989 1994 1999 2004 Year JACC 2005, 46, 2006
  5. 5. Prevalence of emergency CABG after percutaneous coronary interventions from 1992 through 2000 2.0 N = 18,593 PCIs P < 0.001 % Emergency of CABG 1.5 1.0 0.5 0.0 1992 1994 1996 1998 2000 Year of Procedure Circulation October 2002
  6. 6. Prevalence of emergency CABG in Stented and non-stented patients 1992 through 2000 6 Non-stented % Emergency of CABG 5 Stented 4 p< 0.001 3 2 1 0 1992 1994 1996 1998 2000 Year of Procedure Circulation October 2002
  7. 7. Use of Stents and Platelet Glycoprotein IIb/IIIainhibitors in all patients from 1992 through 2000 100 90 IIb/IIIa used 80 Stent used 70 Percent 60 50 40 30 20 10 0 1992 1993 1994 1995 1996 1997 1998 1999 2000 Year of Procedure Circulation October 2002
  8. 8. Predictors for Emergency Coronary Artery BypassGrafting During the Pre-Stent Era (1979 to 1994) Odds Ratio 95% CIPre-procedure shock 2.35 1.33-4.13Acute myocardial infarction 1.82 1.31-2.53Canadian Cardiovascular Society 1.81 1.35-2.42angina class ≥3Angulated segment (>45) 1.66 1.27-2.17Multi-vessel coronary disease 1.55 1.18-2.04Cl = confidence interval. JACC 2005;46,2006
  9. 9. Predictors for Emergency Coronary Artery Bypass Grafting During the Stent Era (1995 to 2003) Odds Ratio 95% CIEmergent PCI 3.77 2.02-7.02Multi-vessel coronary disease 2.40 1.44-4.0Peripheral vascular disease 2.28 1.24-4.17Angulated segment (>45) 1.90 1.19-3.03History of smoking 1.88 1.07-3.28 JACC 2005;46,2006
  10. 10. In-hospital mortality rates of patients requiring emergencycoronary artery bypass grafting after percutaneous coronary intervention from 1979 to 2003 (n = 335) 16 p=0.83 14 In-Hospital Mortality Rate (%) 12 10 8 6 4 2 0 1979-1994 1995-1999 2000-2003 Year JACC 2005, 46, 2006
  11. 11. Time Dependency?
  12. 12. For every 30-minute delay from onset of symptoms to primaryPCI, there is an 8 percent increase in the relative risk of 1-year mortalityImportance of time to reperfusion in patients undergoing primary percutaneous coronary intervention (PCI) for STsegment elevation myocardial infarction (STEMI). This plot is based on the pooled data from 1791 patientsundergoing primary PCI for STEMI. After adjusting for baseline risk, there is a curvilinear relationship between thetime elapsed from the onset of symptoms to balloon inflation and the rate of mortality at 1 year. For every 30-minute delay from onset of symptoms to primary PCI, there is an 8 percent increase in the relative risk of 1-yearmortality. (From De Luca G, Suryapranata H, Ottervanger JP, et al: Time-delay to treatment and mortality in primaryangioplasty for acute myocardial infarction: Every minute counts. Circulation 109:1223, 2004.)
  13. 13. PAMI VS THROMB.META ANALYSISMeta-Analysis of 23 Randomized Trials of Percutaneous CoronaryIntervention (PCI) vs. Lysis (n=7739) PCI (n=3872) Lysis (n=3867) PDeath 270 (7%) 390 (9%) 0.0002Death (Excluding 199 (5%) 276 (7%) 0.0003SHOCK Trial Data)Nonfatal 80 (3%) 222 (7%) < 0.0001ReinfarctionStroke 30(1%) 64 (2%) 0.0004Combined Endpoint 253 (8%) 442 (14%) <0.0001 Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous therapy for acute myocardial infarction: a quantitative review of 23 randomized trials. Lancet 2003:361:13:20
  14. 14. PPCI WITHOUT ONSITE CABG• HOW OFTEN IS THE NEED?• IS IT BETTER THAN FIBRINOLYTICS?• IS IT NON INFERIOR/BETTER THAN ONSITE CABG?• PRECAUTIONS AND CURRENT GUIDELINES
  15. 15. Most of the 1,506 hospitals in the National Registry of Myocardial Infarction-2 had the capability to perform coronary angiogra-phy (Cath-capable), angioplasty(PTCA-capable) or bypass surgery (CABG-capable). CABG = coronary artery bypass graft surgery; PTCA = percutaneous transluminal coronary angioplasty. (From Rogers et al. [20], by permission of the American College of Cardiology) CABG- Nonivasive capable 28% 39% Cath -capable 25% PTCA-capable 8% JACC Vol. 39, No. 12, 2002
  16. 16. PAMI 2- Stone et al ,AJC 2000• 982 patients underwent PPCI• 6.1% needed CABG during index hospital• Only 0.4% of these CABG were emergency procedures after PPCI
  17. 17. Randomized Trials of Primary Stenting Versus BalloonAngioplasty for Acute Myocardial Infarction : Incidence of Emergency CABG for Failed PCI Study (Reference) n Design Emergency CABG for Failed PCI PAMI-STENT (2) 900 Multicenter 4 (0.4%) Suryapranata et al. (13) 452 Single-center 1 (0.2%) FRESCO (14) 150 Single-center 0 GRAMI (15) 104 Multicenter 1(1%) PASTA (16) 136 Multicenter 0 STENTIM-2 (17) 211 Multicenter 0 Total 1,953 6 (0.31%) JACC 2005;46,2006 Singh et al
  18. 18. PPCI WITHOUT ONSITE CABG• WHAT IS THE NEED?• IS IT BETTER THAN FIBRINOLYTICS?• IS IT SAFE/NON INFERIOR OR BETTER THAN AT CENTERS WITH ONSITE CABG?• PRECAUTIONS AND CURRENT GUIDELINES
  19. 19. Thrombolytic Therapy vs PrimaryPercutaneous Coronary Intervention for Myocardial Infarction in PatientsPresenting to Hospitals Without On-site Cardiac Surgery A Randomized Controlled Trial C-PORT JAMA 2002, 287, 1943
  20. 20. Flow of Participants Through The Trial C-PORT 451 Randomized 225 Assigned to 226 Assigned to Primary Receive Percutaneous Thrombolytic Coronary Therapy Intervention 226 Induced in 225 Induced in Analysis Analysis 0 Excluded From 0 Excluded From Analysis Analysis JAMA, April 17, 2002 – Vol 287, No. 15
  21. 21. Primary Outcomes : Treatment-Received Analysis No. (%)Outcome Thrombolytic Therapy (n = Primary PCI P Value 211) (n = 171) 6 WeeksDeath 16 (7.6) 7 (4.1) .15Recurrent Ml 20 (9.5) 7 (4.1) .04Stroke 8 (3.8) 2 (1.2) .11Composite 40 (19.0) 14 (8.2) .003 6 MonthsDeath 16 (7.6) 9 (5.3) .36Recurrent Ml 23 (10.9) 8 (4.7) .03Stroke 8 (3.8) 3 (1.8) .24Composite 43 (20.4) 17 (9.9) .005 CPORT JAMA 2002
  22. 22. CPORTCumulative 6-Week Event-Free Survival 1.0 Cumulative Event-Free Survival Percutaneous Coronary Intervention 0.9 Thrombolytic Therapy 0.8 0.7 No. at Risk Percutaneous 0 Coronary 0 10 20 30 40 Intervention 225 206 202 202 201 Thrombolytic Therapy 226 191 187 186 186 Survival was significantly better (P=.03) in the group receiving thrombolytic therapy JAMA April 17, 2002 Vol. 287, No. 15
  23. 23. PPCI WITHOUT ONSITE CABG• WHAT IS THE NEED?• IS IT BETTER THAN FIBRINOLYTICS?• IS IT SAFE/NON INFERIOR OR BETTER THAN AT CENTERS WITH ONSITE CABG?• PRECAUTIONS AND CURRENT GUIDELINES
  24. 24. Primary Angioplasty Without Cardiac Surgery In-Hospital Outcomes in Patients Undergoing % of Patients Outcome Total Initial Without (n=489) Cardiogenic Shock Shock (n=433) (n = 56)Death 5.3 % 23.2% 3.0 %Reinfarction 2.5 % 1.8 % 2.5 %Reocclusion 3.3 % 1.8 % 3.5 %Stroke or TIA (none 0.4 % 1.8 % 0.2 %hemorrhagic) Wharton et al JACC Vol. 33, No. 5 1999
  25. 25. Primary Angioplasty Without Cardiac Surgery 124 min 4% Death (In-Hospital) 3.9% 102 min 1% Stroke / TIA 0.4% 3% Reinfarction 3.0% 92 % Successful PTCA 99 % 0 10 20 30 40 50 60 70 80 90 100Median Time from ED arrival to Reperfusion Wharton et al JACC Vol. 33 No. 5, 1999
  26. 26. Outcomes of 335 Primary Angioplasty ProceduresOutcome Mean Value ± SD or % of ProceduresPost-PTCA TIMI flow grade0-1 4.8%2 0.9%3 94.3%Post PTCA % stenosis 23 ± 22PTCA success 94.3%In-hospital mortality 6.6%Presenting with cardiogenic shock 25.0%(n = 44)Presenting without shock 3.8%(n = 291) Wharton et al. JACC Vol. 33 No. 5 1999
  27. 27. Time to Treatment in the Air PAMI-No SOS Study Time Intervals (min) Transfer for PA On-Site PA p Value Median Median (25 th, 75th) (25 th, 75th)Chest pain onset to emergency 90 (45,170) 87 (45,167) 0.77center arrivalEmergency center arrival to 155 (119,194) 81 (60,115) <0.0001angiographyEmergency center arrival to balloon 166 (131, 240) 105 (80,139) <0.0001inflationChest pain onset to reperfusion 270 (202, 362) 201 (148, 326) 0.017(balloon inflation) Wharton et al JACC 2004;43,1943
  28. 28. Transfer for PA (n=71) On-Site PA (n=499 20 10 9 8.5 8.5 15 8 7 6.1 4.3 5.2 4.0 p=0.54 30-Day Events 6Days 10 5 5 4 3.4 p=0.27 p=.24 38% 3 5 p=1.00 2 1.4 p=.10 1 1 0.2 0 0 0 Death reMI Disabling CVA MACE Hospital Stay Wharton et al JACC 2004, 43, 1943
  29. 29. Percutaneous Coronary InterventionsIn Facilities Without Cardiac SurgeryOn Site : A Report From the NationalCardiovascular Data Registry (NCDR) Michael A. Kutcher, MD et al JACC, 2009, 54, 1, 16
  30. 30. NCDR –JACC 2009• Data from jan 2004-march 2009• 308161 patients• 465 PCI capable centers• 8736 patients 60 centers with no onsite CABG• 299425 PCI at onsite CABG centers
  31. 31. Pie charts showing the relative distribution of myocardial infarction (Ml) presentation within centers with on- or off-site surgical backup. Off-Site Backup N=8,736 patients Blue areas indicate no Ml; purple areas indicate non-ST-segment elevation myocardial infarction (non-STEMI); yellow areas indicate STEMI. p < 0.001. Off-Site Backup N=8,736 patients On-Site Backup N=299,425 patients 41723 2166 (14%) (25 %) 44896 (15%) 5128 1442 (59 %) 212806 (17 %) (71%) No MI Non-STEMI STEMI JACC Vol. 54, No. 1, 2009 NCDR Offsite PCI
  32. 32. Odds ratio plot of risk-adjusted outcomes, including sensitivity analysis for missing mortality data. Odds ratio: outcomes for patients at off-site (vs. on-site) facili-ties, adjusting for within site correlations and potential confounding variables. ‘Worst case scenario: all patients with missing mortality data wereconsidered to have died. **Best case scenario: all patients with missing mortality data were considered as alive. CABG = coronary artery bypass graft surgery; Cl = confi-dence interval; PCI = percutaneous coronary intervention; pts = patients.Outcome Total N Total N Off-Sit Favors Favors On-Site Odd Ratio (95% CI) p-valueMortality –– overallMortality overall 308,120 308,120 0.90 (0.72 – 1.14) 0.90 (0.72 – 1.14) 0.388 0.388Mortality –– primary PCI ptsMortality primary PCI pts 33,008 33,008 0.97 (0.75 – 1.25)) 0.97 (0.75 – 1.25) 0.807Mortality –– non-primary PCI pts 275,098Mortality non-primary PCI pts 275,098 0.86 (0.63 – 1.16) 0.86 (0.63 – 1.16) 0.319 0.319 Emergency CABGEmergency CABG 308,121 308,121 0.60 (0.37 – 0.98)) 0.60 (0.37 – 0.98) 0.042 0.042Mortality –– pts not requiringMortality pts not requiring 306,962 306,962 0.93 (0.73 – 1.17) 0.93 (0.73 – 1.17) 0.533 0.533emergency CABG emergency CABGSensitive Analysis Sensitive AnalysisMortality – impute to YesYes Mortality – impute to 308,161 308,161 1.21 (0.95 – 1.54) 1.21 (0.95 – 1.54) 0.120 0.120for for Off-site Off-siteMortality – impute to No No Mortality – impute to 308,161 308,161 0.88 (0.70 –– 1.11) 0.88 (0.70 1.11) 0.281 0.281for for Off-site Off-site 0.1 1 10 JACC Vol. 54, No. 1, 2009 NCDR Offsite CI
  33. 33. Physician Volume and Outcome of Primary PCI Average Mortality by Physician and Hospital VolumePhysician Volume Hospital Volume Patients, n Observed Mortality Risk-Adjusted Mortality Rate> 10/yr (n = 90) >50/yr 4,712 3.2 (0.33) 3.8 (0.42)>10/yr (n = 36) ≤50/yr 526 3.5 (0.90) 4.8 (123)≤10/yr (n = 140) >50/yr 1,461 4.2 (0.90) 6.5 (2.12)≤ 10/yr (n = 97) ≤50/yr 622 6.7 (1.6) 8.4 (2.73)>20/yr (n = 29) >50/yr 2,424 2.8 (0.40) 3.5 (4.27)>20/yr (n = 10) ≤50/yr 106 3.0 (1.9) 2.6 (139)≤ 20/yr (n = 201) >50/yr 3,749 4.0 (0.6) 5.7(1.50)≤20/yr (n = 123) ≤50/yr 1,042 6.1(1.2) 6.1(1.2) JACC Vol. 53 No. 7, 2009
  34. 34. Volume-Outcome Relationship for Hospitals and Physicians 15% Risk Adjusted Mortality 6 % Risk Adjusted Mortality 10 4 State-wide mortality 5 2 State-wide mortality 0 0 0 50 100 150 200 0 10 20 30 ≥36 Annual Hospital Volume (per year) Annual Physician Volume (per year) 52 43 33 25 21 11 22 15 7 8 8 4 2 2 0 2 4 7 No. of Physicians Srinivas et al JACC 2009, 53, 574
  35. 35. PPCI WITHOUT ONSITE CABG• WHAT IS THE NEED?• IS IT BETTER THAN FIBRINOLYTICS?• IS IT SAFE/NON INFERIOR OR BETTER THAN AT CENTERS WITH ONSITE CABG?• PRECAUTIONS AND CURRENT GUIDELINES
  36. 36. Points To Ensure1) The risks and benefits of primary PCI versus thrombolytic therapy;2) The risks and benefits of primary PCI versus transfer of patients to an institution with on-site cardiac surgical capabilities for those not eligible for thrombolytic therapy;3) The outcome for patients who are treated with the intention that they will receive primary angioplasty, but who do not receive it;4) The frequency of and indications for emergency CABG unrelated to PCI complications;5) The management of PCI complications that may be alleviated by emergency CABG;6) The requirements that must be met in hospitals without on-site cardiac surgical capabilities to perform primary PCI safely and effectively.
  37. 37. 2011 ACC/AHA/SCAI GUIDELINES EXECUTIVE SUMMARY• CLASS IIA:LEVEL OF EVIDENCE B• PPCI is reasonable in hospital without onsite CABG provided that appropriate placing of program development has been accomplished
  38. 38. PPCI WITHOUT ONSITE CABG• CLASS III-HARM!!!• PPCI should not be performed in hospital without a plan for rapid transport to operating room in a nearby hospital Or without proper hemodynamic support for transport

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