american heart association scientific sessions – november 4, 2007

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, 2007American Heart Association Scientific Sessions – November 4, 2007

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.

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 2003Cheavlier et al. CCI 2003Dauerman et al. Journal of the American College of Cardiology 2007Dauerman et al. Journal of the American College of Cardiology 2007Koreny, M. et al. JAMA 2004Koreny, M. et al. JAMA 2004

Aim

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

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.

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

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.

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.

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.

Baseline DemographicsVariable

Total (n=227,87

9)

ACD (n=109,28

1)

Manual (n=118,59

8)p-value

Age 64 (55,73) 64 (55,73) 65 (56,74) <0.001

Male (%) 66 68 65 <0.001

Diabetes (%) 32 31 33 <0.001

PVD (%) 12 10 14 <0.001

HTN (%) 76 75 77 <0.001

Tobacco (%) 62 61 63 <0.001

Dyslipidemia 74 74 74 0.33

Creat > 1.5 g/dl 12 11 13 <0.001

FHx premature CAD (%) 29 30 28 <0.001

Previous PCI (%) 36 36 36 0.68

Prev CABG (%) 19 18 20 <0.001

ACS (%) 63 60 65 <0.001

Procedural Medications

MedicationTotal

(n=227,879)

ACD (n=109,28

1)

Manual (n=118,59

8)

P Value

On thienopyridine prior to PCI (%)

74 76 72 <0.001

2b/3a (%) 48 46 49 <0.001

LMWH (%) 17 17 16 <0.001

UFH (%) 57 54 59 <0.001

DTI (%) 32 34 30 <0.001

Unadjusted Incidence of Vascular Complications, Stratified by ACD.

MedicationTotal

(n=227,879)

ACD (n=109,2

81)

Manual (n=118,5

98)

p-value

Any vascular complication (%)

1.7 1.4 1.9<0.001

Entry site bleeding (%) 1.0 0.8 1.1<0.001

RP Bleeding (%) 0.4 0.5 0.3<0.001

Access site occlusion (%) 0.04 0.05 0.03 0.06

AV Fistula (%) 0.07 0.03 0.10<0.001

Peripheral Embolization (%)

0.05 0.04 0.06<0.001

Pseudoaneurysm (%) 0.35 0.10 0.58<0.001

Adjusted Analysis of Vascular Complications Associated with ACDs. GEE model.

OutcomeOdds Ratio (95 %

CI)P Value

Any Vascular Complication 0.76 (0.70-0.84) <0.001

Entry Site Bleeding 0.79 (0.71-0.88) <0.001

RP Bleeding 1.67 (1.42-2.00) <0.001

Access Site Occlusion 2.22 (1.44-3.42) <0.001

AV Fistula 0.42 (0.26-0.65) <0.001

Peripheral Embolization 0.81 (0.52-1.25) 0.34

Pseudoaneurysm 0.19 (0.15-0.23) <0.001

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.

Outcome: Any Vascular Complication, stratified by site-level % ACD Use

(per 10% increase)

Unadjusted Adjusted

OR 95% CIP

ValueOR 95% CI

P Value

0.99

0.97-1.01

0.430.99

0.98-1.01 0.54

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.

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

Future Directions

• Other analyses planned to attempt to address residual confounding:– Propensity analyses