Trans-Radial approach in Overweight Patients Hakim Ben Amer, MD On behalf the TROP study group

Predicting vascular complications in percutaneous coronary interventions 18,137 PCI pts in northern New England ( ); vascular complication* 2.98% Variables associated with increased risk in the multivariate analysis Age >or=70 OR 2.7 Female gender OR 2.4 Body surface area <1.6 m OR 1.9 History of congestive heart failure OR 1.4 Chronic obstructive pulmonary disease OR 1.5 Renal failure OR 1.9 Lower extremity vascular disease OR 1.4 Bleeding disorder OR 1.68 Emergent priority OR 2.3 Myocardial infarction OR 1.7 Shock OR 1.86 >or=1 type B2 lesions OR 1.32 type C lesions OR vessel PCI OR 1.5 Thienopyridines OR 1.4 Glycoprotein IIb/IIIa inhibitors OR 1.9 Piper WD Am Heart J Jun;145(6): *Vascular complications: access-site injury requiring treatment or bleeding requiring transfusion

Complications following diagnostic coronary angiography: Predicting factors Ammann CCVI 2003;59:13-18 FactorAll complicationsMajor complicationsVascular complications Heart failure (Killip>1) 0R 2.16; 95% CI ; p= 0.03 Left / Right catheterization 0R 2.62; 95% CI ; p= Senior physician (> 500) 0R 0.58; 95% CI ; p= 0.04 French: 6 0R 2.6; 95% CI ; p= R 2.35; 95% CI ; p= R 2.54; 95% CI ; p= 0.07 Smoking 0R 2.76; 95% CI ; p= R 3.93; 95% CI ; p= 0.01 Body weight (/10 kg) 0R 1.23; 95% CI ; p= 0.1 0R 1.4; 95% CI ; p= ,412 consecutive diagnostic cardiac catheterizations between 1990 and 2000

Impact of Access Site Hematoma With Transfusion in Patients Undergoing Percutaneous Coronary Intervention 6613 PCI (98-00)(NHLBI): hematoma w transfusion 1.8% (97% femoral) Predictors: Older age, Lower BMI, Female, renal disease, HTN, AMI, 3- VD, GPIIb/IIa -, Postprocedure heparin Independent predictors: Older age, female, thrombotic lesion, 3-VD, renal disease, emergent PCI, prior aspirin Procedural death: 10.3% w HWT 1.2% w/o HWT p <0.001 death/MI: 18.1% 3.55% <0.001 HWT is a predictor of death/MI (OR = 3.49; 95% CI: ) J. Slater Am J Cardiol 2003 (suppl) 92: 18L

Clinical Significance of Bleeding Complications From Blankenship Am Heart J 1999; 138: S287-S296 Median Length of Hospital Stay (Day) Extra CostOthers Any Vascular Site Bleeding or Vascular Complication (Surgical) + 1 Incapacitation (days- weeks) Return to normal activity delay Major or Minor Vascular Site Bleeding or Vascular Complication (Surgical) $- Major Vascular Site Bleeding or Vascular Complication (Surgical) $-

Radial / Femoral Approach meta-analysis: Entry site complications Agostini P JACC

TransRadial Approach In OverWeight Patients - Multicentric European Registry, - Coronary angiography (CA) or angioplasty (PCI) - Centres where there is at least one operator with a wide experience in the transradial approach for CA and PCI. - We include in the registry all the overweight patients with BMI  35, undergoing CA and/or PCI whatever the vascular approach chosen by the operator. -The primary end point is the occurrence of complications delaying the hospital discharge. TROP Study Group

TROP Centers - Bergamo (Italy) - Brighton (England) - CHU Caen, (France) - HEP la Roseraie, (France) - Clinic Barcelona, (Spain) - Hôpital Bichat, Paris (France) - ICPS, Massy (France) - ICPS, Quincy (France) - Meixoeiro, (Spain) - Riga, (Latvia) - Szeged, (Hungary) - Val-de-Grâce (France) - Valle de Hebron, (Spain)

TROP Study Group N = 346

Clinical Datas Mean Age / years (30/83) Sexe (Male)52.9 % Mean Weight108 +/- 15 Kg(79/155) Mean Height1.67 +/- 0.1 M(1.45/1.90) Mean BMI38.7 +/- 3.4 Kg/m2(35/56) Renal Insuf7.8% TROP Study Group

Clinical Datas TROP Study Group %

Clinical Datas TROP Study Group Radial N = 249 Femoral N = 97 Angio (%)171 (49.4)52 (14.7) PCI (%)19 (5.5)21 (6.1) Angio/PCI (%)59 (17.1)25 (7.2) P =.0006

Clinical Datas TROP Study Group %

Clinical Datas TROP Study Group %

Vascular Access Transradial approach IT: 249/346 (71.9%) Transradial approach AC: 243/346 (70.2%) Reasons for using Femoral access: 97/346 (28.1%) - Physician choice (76): 78.4% - Dialysis (1): 1% - Need for 7F catheters (5): 5.2% - Abnormal Allen test (1): 1% - CABG (double Mam) (4): 4.1% - No or to small radial (4): 4.1% - Other (ring, prior rad failure…) (6): 6.2% TROP Study Group IT: Intention To Treat AC: After Cross over

Vascular Access Cross over: 17 (4.9%) - Radial to femoral: 9 (3.6%) - Radial to radial:4 (1.6%) - Femoral to radial:3 (3.1%) - Radial to Ulnar1 (0.4%) TROP Study Group

Vascular Access: Size TROP Study Group N

INDICATIONS TROP Study Group %

Clinic Presentation TROP Study Group %

Documented Ischemia TROP Study Group %

Vascular Access Radial difficulties: 249 patients - Failure: 10 (4%) - No difficulty210 (84.3%) - Catheterism diff.10 (4%) - Spasm6 (2.8%) - Loops10 (4%) - Others2 (0.8%) - TOTAL29 (11.6%) TROP Study Group

CAD extension TROP Study Group %

PCI (N = 124 pts) - Transradial access: 78/124 (62.9%) - Femoral access: 46/124 (38.1%) - PCI success/Vessel: 163/169 (96.5%) - Clinical Total Success: 118 (95.2%) - QMI: 4 (3.2%) - MACE: 1 (3.2%) - Emergent CABG: 0 (0%) - Death: 0 (0%) TROP Study Group

Fem vs Rad access Radial (n=243) Femoral (n=103) P Mean age (y) / /- 10.1NS Male (%) 138 (56.7)56 (54.4)NS BMI (Kg/m2) 39 +/ / TROP Study Group

Radial (n=243) Femoral (n=103) P Hypertension (%)180 (70)76 (70)NS Hypercholesterolemia (%)165 (68)72 (70)NS Family History (%)41 (17)40 (39)0,001 Smokers (%) No Current Past 137 (56) 30 (12) 60 (25) 60 (58) 17 (16) 26 (25) NS Diabetes (%) No ID NID 137 (56) 24 (10) 82 (34) 65 (63) 9 (9) 29 (28) NS Fem vs Rad access TROP Study Group

Fem vs Rad access TROP Study Group Radial (n=243) Femoral (n=103) P Prior MI (%) 37 (15)27 (26)NS Prior CABG (%) 11 (45)8 (8)NS Prior PCI (%) 42 (18)17 (16)NS

Radial (n=243)Femoral (n=103)P Nb Cath used Angio (n)1.9 +/ /- 0.70,0005 Contrast Total (ml)159 +/ / Contrast Angio (ml)117 +/ /- 70NS Total Duration (min)35.3 +/ / Angio Duration (min)26.1 +/ / Hosp stay (d)3.7 +/ /- 4.6NS Hosp stay after C (d)1.7 +/ / Vascular complication (%)*3 (1.2)3 (2.9)NS Hematoma (%)4 (1.6)9 (8.7) §0.001 Fem vs Rad access TROP Study Group * With transfusion§: with 8 Closing Device

Impact of Weight for in Hospital Outcome after PCI RM, Minuella Am J cardiol 2004;93: BMI (kg/m2) N=95435 < 18,5 N=924 18,5/24,9 N= /29,9 N= /34,9 N= /39,9 N6252 >40 N=2745 P Death (%)3,81,10,80,70,61,40,001 Transmural MI (%) 0,50,3 0,40,3 0,227 Emergent CABG (%) 0,91,31,1 1,20,8<0,001 MACE (%)52,62,12,01,82,4<0,001 Vascular Injury (%) 1,40,60,5 0,9<0,001

Conclusion 1 Obesity is a risk factor for CAD (Hypertension, Dyslipidemia, Diabetes) Obesity is more frequent in female gender Obesity is a factor of complication in diagnostic angiography and coronary intervention

Conclusion 2 Preliminary analysis of this study Radial approach in obese patients reduces the rate of vascular complications Subgroup analysis (pending) is necessary to better define patients at higher risk, interest of closure devices for femoral procedures… Potential other advantage of radial approach: prevention of infectious complication

Bleeding Complications F.V Aguirre et al, Circulation 1995;91:

Bleeding complications

Comparison of the Risk of Vascular Complications Associated With Femoral and Radial Access Coronary Catheterization Procedures in Obese Versus Nonobese Patients N Cox, Am J Cardiol 2004;94:1174–1177 Distribution of patients who underwent cardiac catheterization procedures by BMI

Comparison of the Risk of Vascular Complications Associated With Femoral and Radial Access Coronary Catheterization Procedures in Obese Versus Nonobese Patients N Cox, Am J Cardiol 2004;94:1174–1177

Comparison of the Risk of Vascular Complications Associated With Femoral and Radial Access Coronary Catheterization Procedures in Obese Versus Nonobese Patients N Cox, Am J Cardiol 2004;94:1174–1177

Comparison of the Risk of Vascular Complications Associated With Femoral and Radial Access Coronary Catheterization Procedures in Obese Versus Nonobese Patients N Cox, Am J Cardiol 2004;94:1174–1177 Vascular complications by BMI. The patients with the smallest BMIs experienced the highest rate of vascular complications

Comparison of the Risk of Vascular Complications Associated With Femoral and Radial Access Coronary Catheterization Procedures in Obese Versus Nonobese Patients N Cox, Am J Cardiol 2004;94:1174–1177 Overall vascular complication rate in nonobese and obese (BMI >30.0) patient subgroups stratified by vascular access approach

Comparison of the Risk of Vascular Complications Associated With Femoral and Radial Access Coronary Catheterization Procedures in Obese Versus Nonobese Patients N Cox, Am J Cardiol 2004;94:1174–1177

Low-Normal or Excessive Body Mass Index: Newly Identified and Powerful Risk Factors for Death and Other ComplicationsWith Percutaneous Coronary Intervention Stephen G. Ellis, Am J Cardiol 1996;78: Major Cardiac Outcomes and Complications

Low-Normal or ExcessiveBody Mass Index: Newly Identified and Powerful Risk Factors for Death and Other Complications With Percutaneous Coronary Intervention Stephen G. Ellis, Am J Cardiol 1996;78: Peripheral Vascular Complications

Low-Normal or ExcessiveBody Mass Index: Newly Identified and Powerful Risk Factors for Death and Other Complications With Percutaneous Coronary Intervention Stephen G. Ellis, Am J Cardiol 1996;78: Independent Correlates of Death With and Without BMI

Low-Normal or ExcessiveBody Mass Index: Newly Identified and Powerful Risk Factors for Death and Other Complications With Percutaneous Coronary Intervention Causes of Death Stephen G. Ellis, Am J Cardiol 1996;78:642-64

Low-Normal or ExcessiveBody Mass Index: Newly Identified and Powerful Risk Factors for Death and Other ComplicationsWith Percutaneous Coronary Intervention Stephen G. Ellis, Am J Cardiol 1996;78:642-64

Impact of Body Mass Index on Outcome After Percutaneous Coronary Intervention (The Obesity Paradox) H Gurm, P. Topol Am J Cardiol 2002; 90: 42-45

Impact of Body Mass Index on Outcome After Percutaneous Coronary Intervention (The Obesity Paradox) H Gurm, P. Topol Am J Cardiol 2002; 90: 42-45

Impact of Body Mass Index on Outcome After Percutaneous Coronary Intervention (The Obesity Paradox) H Gurm, P. Topol Am J Cardiol 2002; 90: 42-45

Impact of Body Mass Index on Outcome After Percutaneous Coronary Intervention (The Obesity Paradox) H Gurm, P. Topol Am J Cardiol 2002; 90: 42-45

Impact of BMI on Short- and Long-Term FU in Patients Undergoing Coronary Revascularization: Insights From BARI H. Gurm J Am Coll Cardiol 2002;39:834–40 Procedural Characteristics of Study Patients According to BMI

Impact of BMI on Short- and Long-Term FU in Patients Undergoing Coronary Revascularization: Insights From BARI Incidence and Odds Ratios of In-Hospital Events According to BMI: PTCA Group H. Gurm J Am Coll Cardiol 2002;39:834–40

Impact of BMI on Short- and Long-Term FU in Patients Undergoing Coronary Revascularization: Insights From BARI H. Gurm J Am Coll Cardiol 2002;39:834–40 Incidence and Odds Ratios of In-Hospital Events According to BMI: CABG Group

Impact of BMI on Short- and Long-Term FU in Patients Undergoing Coronary Revascularization: Insights From BARI H. Gurm J Am Coll Cardiol 2002;39:834–40 Incidence and OR of Long-Term Mortality According to BMI: PTCA Group (n=2,090)

H. Gurm J Am Coll Cardiol 2002;39:834–40 Impact of BMI on Short- and Long-Term FU in Patients Undergoing Coronary Revascularization: Insights From BARI Incidence and OR of In-Hospital Events According to BMI: CABG Group

Obesity a risk for CABG surgery N.J.O. Birkmeyer Circulation 1998;97:

Obesity a risk for CABG surgery N.J.O. Birkmeyer Circulation 1998;97: CVA Cerebrovascular Accident SWI Sternal Wound infection