1. Use of Arteriotomy Closure Devices and the Risk of Vascular Complications: An Analysis of 227,879 Patients in the NCDR Sameer K. Mehta MD, Andrew D. Frutkin MD, Sunil V. Rao MD, Tracy Y. Wang MD, MS, David Dai MS, David J. Cohen MD, MSc, Steven P. Marso MD, on behalf of the NCDR The Mid America Heart Institute and Duke Clinical Research Institute. American Heart Association Scientific Sessions – November 4, 2007

2. Presenter Disclosure Information Sameer K. Mehta MD et al. Use of Arteriotomy Closure Devices and the Risk of Vascular Complications: An Analysis of 227,879 Patients in the NCDR. No authors report any disclosures or conflicts of interest.

3. Background Arteriotomy Closure Devices (ACD’s) are an alternative method of hemostasis after PCI. ACD’s reduce time to hemostasis, decrease time to ambulation, and shorten hospital stay. Conclusions regarding ACDs and vascular complications are limited –Non-uniformity of study end-points –Disparate conclusions. Thus, the relationship between ACD use and vascular complications remains controversial. Cheavlier et al. CCI 2003 Dauerman et al. Journal of the American College of Cardiology 2007 Koreny, M. et al. JAMA 2004

4. Aim To determine whether ACDs are associated with an increased incidence of vascular complications in a contemporary PCI setting

5. Methods Version 3.04 of NCDR Cath-PCI Registry Contains data from PCI procedures performed from Jan. 1, 2004 to March 31, 2006 at over 600 U.S. Hospitals Exclusion Criteria: –16,569 patients who received lytics. –22,246 patients who were coded as “no attempt of hemostasis.” –701 patients whose hemostasis method was coded as “other.” –39,164 patients who were treated with mechanical compression devices. –24,782 patients treated with vascular patches.

6. Study Population Final population consists of 227,879 patients who underwent PCI via femoral access –109,281 patients treated with ACD –118,598 patients treated by manual compression ACD group consisted of all types of ACDs –suture alone, extravascular collagen alone, suture- collagen combinations, and staple/clip technologies

7. ACC-NCDR End Point Definitions Entry Site Bleeding –during hospitalization –required a transfusion and/or prolonged the hospital stay and/or caused a Hgb drop > 3.0 g/dl –external or a hematoma >10cm RP Bleed –during hospitalization –required transfusion and/or prolonged hosp stay, and/or Hgb drop > 3.o g/dl. Pseudoaneurysm –by US or arteriography. AV Fistula –by US or arteriography Access Site Occlusion –total obstruction of the artery, usually at the site of access, requiring surgical repair.

8. Methods Primary end-point was a composite of any vascular complication. We compared unadjusted and adjusted rates of vascular complications in 2 groups: – ACD –manual compression.

9. Methods - Analysis Adjusted analyses were performed using generalized estimating equation models. –Models adjusted for age, gender, diabetes, hypertension, creatinine clearance, congestive heart failure, peripheral vascular disease, medications (including warfarin, heparin, thrombin inhibitors, and platelet aggregation inhibitors), and the presence of an acute PCI.

10. Baseline Demographics Variable Total (n=227,879) ACD (n=109,281) Manual (n=118,598) p-value Age64 (55,73) 65 (56,74)<0.001 Male (%)666865<0.001 Diabetes (%)323133<0.001 PVD (%)121014<0.001 HTN (%)767577<0.001 Tobacco (%)626163<0.001 Dyslipidemia74 0.33 Creat > 1.5 g/dl121113<0.001 FHx premature CAD (%)293028<0.001 Previous PCI (%)36 0.68 Prev CABG (%)191820<0.001 ACS (%)636065<0.001

11. Procedural Medications Medication Total (n=227,879) ACD (n=109,281) Manual (n=118,598) P Value On thienopyridine prior to PCI (%) 747672<0.001 2b/3a (%)484649<0.001 LMWH (%)17 16<0.001 UFH (%)575459<0.001 DTI (%)323430<0.001

12. Unadjusted Incidence of Vascular Complications, Stratified by ACD. Medication Total (n=227,879) ACD (n=109,281) Manual (n=118,598) p- value Any vascular complication (%) 1.71.41.9<0.001 Entry site bleeding (%)1.00.81.1<0.001 RP Bleeding (%)0.40.50.3<0.001 Access site occlusion (%)0.040.050.030.06 AV Fistula (%)0.070.030.10<0.001 Peripheral Embolization (%)0.050.040.06<0.001 Pseudoaneurysm (%)0.350.100.58<0.001

13. Adjusted Analysis of Vascular Complications Associated with ACDs. GEE model. OutcomeOdds Ratio (95 % CI)P Value Any Vascular Complication0.76 (0.70-0.84)<0.001 Entry Site Bleeding0.79 (0.71-0.88)<0.001 RP Bleeding1.67 (1.42-2.00)<0.001 Access Site Occlusion2.22 (1.44-3.42)<0.001 AV Fistula0.42 (0.26-0.65)<0.001 Peripheral Embolization0.81 (0.52-1.25)0.34 Pseudoaneurysm0.19 (0.15-0.23)<0.001

14. Are ACD’s protective? If ACDs are protective against vascular complications, then we should observe a reduction in complications with increased use. Thus, we stratified population by the % ACD use per site.

15. Outcome: Any Vascular Complication, stratified by site-level % ACD Use (per 10% increase) UnadjustedAdjusted OR95% CIP ValueOR95% CIP Value 0.990.97-1.010.430.990.98-1.010.54

16. Conclusions In our large observational analysis, ACD use was associated with an overall reduction in vascular complications. However, increased ACD use did not convey a protective benefit. The discrepancy between these two findings may be the result of unmeasured confounders.

17. Limitations Low incidence of complications Lack of randomization –Selection bias as to who received ACD vs. manual compression –Unable to adjust for unmeasured covariates Unable to measure other potential benefits of ACDs –time to ambulation –patient comfort

18. Future Directions Other analyses planned to attempt to address residual confounding: –Propensity analyses