Femoral arterial puncture is the most common access method for coronary angiography and percutaneous coronary interventions (PCIs). Access complications, although infrequent, affect morbidity, mortality, costs, and length of hospital stay. Vascular closure devices (VCDs) are used for rapid hemostasis and early ambulation, but there is no consensus on whether VCDs are superior to manual compression (MC). A retrospective review and nested case–control study of consecutive patients undergoing elective transfemoral coronary angiography and PCI over 3 years was performed. Hemostasis strategy was performed according to the operators’ discretion. Vascular complications were defined as groin bleeding (hematoma, hemoglobin decrease ≥3 g/dl, transfusion, retroperitoneal bleeding, or arterial perforation), pseudoaneurysm, arteriovenous fistula formation, obstruction, or infection. Patients with postprocedure femoral vascular access complications were compared to randomly selected patients without complication. Data were available for 9,108 procedures, of which PCI was performed in 3,172 (34.8%). MC was performed in 2,581 (28.3%) and VCDs (4 different types) were deployed in 6,527 procedures (71.7%). Significant complications occurred in 74 procedures (0.81%), with 32 (1.24%) complications with MC and 42 (0.64%) with VCD (p = 0.004). VCD deployment failed in 80 procedures (1.23%), of which 8 (10%) had vascular complications. VCD use was a predictor of fewer complications (odds ratio 0.52, 95% confidence interval 0.33 to 0.83). In the case–control analysis, older age and use of large (7Fr to 8Fr) femoral sheaths were independent predictors of complications. In conclusion, the retrospective analysis of contemporary hemostasis strategies and outcomes in elective coronary procedures identified a low rate of complications (0.81%), with superior results after VCD deployment. Careful selection of hemostasis strategy and closure device may further decrease complication rates.
Femoral arterial puncture is the most commonly used arterial access method for diagnostic and interventional coronary procedures. Manual compression (MC) with prolonged bedrest to achieve hemostasis has been increasingly replaced by the use of vascular closure devices (VCDs). The use of VCDs enables rapid postprocedure hemostasis, a shorter duration of bedrest with sooner ambulation, and earlier discharge. Different of VCDs have been approved for use in the United States including suture-based, sealant-based, and collagen-plug based devices. With improved operator experience and the development of newer generations of closure devices, complication rates have decreased. Even with these improvements, complications of vascular access continue to affect procedure-related morbidity and mortality, hospital length of stay, and health care costs. Despite the potential benefits and improvements with VCDs, there is still no consensus on whether they are superior to MC. Few large studies have compared vascular access strategies in patients undergoing elective coronary procedures. We performed a retrospective review of consecutive patients who underwent elective coronary angiography or intervention with femoral arterial access to evaluate patterns of use and outcomes associated with various vascular closure strategies in the modern era of elective angiography.
Methods
This is a retrospective evaluation of consecutive patients undergoing ambulatory elective transfemoral coronary angiography at the New York-Presbyterian/Columbia University Medical Center from January 1, 2008 to December 31, 2010. Emergency and inpatient coronary procedures were excluded from analysis. In patients who presented for an elective coronary procedure and required hospital admission, all subsequent in-hospital interventions were excluded from analysis. In total 8,580 patients underwent 9,861 elective coronary angiographic procedures and percutaneous coronary interventions (PCIs) during the study period. Of these, 736 were accessed through the radial artery and 9 through the brachial artery. Femoral arterial access was used in 9,116 procedures (92.4%); 8 procedures were excluded because of incomplete data. The remaining 9,108 procedures in 7,994 patients were the basis for study analysis.
For femoral arterial access, operators identified bony anatomic landmarks by fluoroscopy and attempted a single anterior common femoral puncture. As an institutional protocol, all patients (even patients undergoing diagnostic angiography) received aspirin (loading dose 325 mg, maintenance 81 mg/day) and clopidogrel (loading dose 600 mg ≥2 hours before the procedure, maintenance 75 mg/day) when PCI was planned or optional unless contraindications existed. Anticoagulation with heparin or bivalirudin was administrated for interventional cases. Use of IIb/IIIa inhibitors was at the discretion of each operator.
Sheath removal after PCI was performed according to local hospital protocol. Operators selected VCD or MC as the primary method of hemostasis. When a VCD was selected, it was deployed immediately after completion of the procedure. Sheath removal and MC were performed immediately if no antithrombin was administered, when activated clotting time was <170 seconds in patients treated with heparin, or 2 hours after discontinuation of bivalirudin.
The VCDs that were used included Angioseal (St. Jude Medical, St. Paul, Minnesota), Perclose-Proglide and Starclose (Abbott Vascular, Redwood City, California), and Mynx (AccessClosure, Mountain View, California). Certified experienced operators deployed all closure devices according to the manufacturers’ instructions for use. Ambulation was initiated 2 hours after hemostasis after diagnostic angiography without administration of anticoagulation. After PCI with administration of anticoagulation, ambulation was initiated 2 hours after deployment of a VCD and 6 hours after hemostasis with MC. Postprocedure access-site evaluation and documentation were systematically performed by experienced catheterization laboratory staff.
All documented access-site vascular complications were reviewed. Major vascular complications were defined as significant groin bleeding (resulting in blood transfusion, hemoglobin decrease ≥3 g/dl, hematoma ≥5 cm, retroperitoneal bleeding, femoral artery perforation, or bleeding leading to increased length of hospitalization ≥2 nights), pseudoaneurysm (documented by ultrasonography), arteriovenous fistula formation, vascular obstruction, or access-site infection. VCD failure was defined by unsuccessful deployment or failure to achieve hemostasis.
Patients with postprocedure access complications were compared 1:1 to randomly selected controls without evidence of vascular complication in a nested case–control method. Hospital charts were reviewed to identify clinical, procedural, and laboratory data. Statistical analyses were conducted by unpaired Student’s t test for normally distributed continuous data and by chi-square and Fisher’s exact tests for categorical variables. Conditional logistic regression was used to identify independent predictors of vascular complications in the nested case–control subset. Statistical models were generated based on clinically relevant covariates and those identified during univariate analysis (age, gender, body mass index, chronic kidney disease, history of repeat femoral access, sheath size, closure strategy), followed by stepwise selection and backward elimination of nonsignificant variables. After establishing baseline significant predictors, a second model was developed to assess the additive predictive influence of closure strategy. Binomial logistic regression was used for the unmatched study population, with a model generated through backward elimination to include significant covariates and independent variables with strong trends toward predictive significance. Two-tailed p values <0.05 were considered statistically significant for all tests. All statistical analyses were conducted using SPSS 19 (IBM, Armonk, New York). The study was approved by the local institutional review board.
Results
In total 7,994 patients underwent 9,108 consecutive elective coronary procedures by femoral arterial access, with full documentation available for this study. Diagnostic angiography only was performed in 5,936 procedures (65.2%); PCI was performed in 3,172 procedures (34.8%). Device-based closure was the primary method of hemostasis in 6,527 procedures (71.7%), with MC applied in the remaining 2,581 (28.3%). VCDs were selected for hemostasis in 2,205 PCI procedures and 4,322 diagnostic angiographic procedures (69.5% vs 72.7%, p <0.001).
Vascular access-site complications occurred in 74 procedures (0.81%). No patient in the study had >1 vascular complication. Baseline characteristics of patients with complications are listed in Table 1 ; procedural variables are listed in Table 2 . Complication rates were similar between PCIs and diagnostic angiographic procedures (32 [1.0%] complications with PCI vs 42 [0.71%] after diagnostic angiography, p = 0.13). Primary vascular-access complications included significant groin and retroperitoneal bleeding (n = 40), pseudoaneurysm (n = 20), vascular occlusion (n = 8), arteriovenous fistula (n = 5), and infection (n = 1). Large hematoma of >5 cm (n = 25) was the most common complication after device closure and MC ( Table 3 ). Bleeding by Thrombolysis In Myocardial Infarction criteria was observed in 25 cases (16 cases with overt groin bleeding or hematoma, 4 with pseudoaneurysm, 4 with retroperitoneal bleed, and 1 with perforation). One patient with a large access-site hematoma also developed lower-extremity ischemia from an arterial thrombus. None of the complications was associated with mortality.
| Variable | Vascular Complication | p Value | |
|---|---|---|---|
| Yes (n = 74) | No (n = 74) | ||
| Age (years) | 70.5 ± 13.0 | 64.4 ± 12.3 | 0.004 |
| Men | 39 (53%) | 50 (68%) | 0.06 |
| Previous myocardial infarction | 20 (27%) | 13 (18%) | 0.17 |
| Previous percutaneous coronary intervention | 33 (45%) | 28 (38%) | 0.4 |
| Previous coronary bypass | 13 (18%) | 10 (14%) | 0.5 |
| Mean ejection fraction (%) | 53.2 ± 9.3 | 51 ± 10.8 | 0.23 |
| Documented hypertension | 55 (74%) | 53 (72%) | 0.71 |
| Documented dyslipidemia | 52 (70%) | 44 (60%) | 0.17 |
| Diabetes mellitus | 22 (30%) | 25 (34%) | 0.6 |
| Chronic kidney disease (glomerular filtration rate <60 ml/min) | 29 (39%) | 18 (24%) | 0.05 |
| End-stage renal disease | 1 (1%) | 5 (7%) | 0.1 |
| Weak/absent distal pulses | 17 (23%) | 17 (23%) | 1 |
| Peripheral arterial disease | 14 (19%) | 16 (22%) | 0.68 |
| Smoking history | 21 (28%) | 22 (30%) | 0.86 |
| Platelet count <100/mm 3 | 4 (5%) | 1 (1%) | 0.17 |
| Mean international normalized ratio | 1.2 ± 1.2 | 1.0 ± 0.2 | 0.23 |
| Body mass index (kg/m 2 ) | 28 ± 5.1 | 28.9 ± 5.3 | 0.34 |
| Number of coronary arteries narrowed | 0.82 ⁎ | ||
| 0 | 21 (28%) | 21 (28%) | |
| 1 | 14 (19%) | 18 (24%) | |
| 2 | 18 (24%) | 18 (24%) | |
| 3 | 21 (28%) | 17 (23%) | |
| Variable | Vascular Complication | p Value | |
|---|---|---|---|
| Yes (n = 74) | No (n = 74) | ||
| Percutaneous coronary intervention | 32 (43%) | 30 (41%) | 0.73 |
| Femoral access site | |||
| Right femoral access | 54 (73%) | 64 (87%) | 0.04 |
| Left femoral access | 11 (15%) | 7 (10%) | 0.31 |
| Right and left femoral access | 9 (12%) | 3 (4%) | 0.07 |
| Repeat femoral access ⁎ | 18 (24%) | 22 (30%) | 0.46 |
| Anticoagulation/antiplatelet | |||
| None | 14 (19%) | 20 (27%) | 0.24 |
| Aspirin | 68 (92%) | 62 (84%) | 0.13 |
| Clopidogrel | 59 (80%) | 51 (69%) | 0.13 |
| Ticlopidine | 1 (1%) | 0 (0%) | 0.32 |
| Bivalirudin | 38 (51%) | 31 (42%) | 0.25 |
| Heparin | 11 (15%) | 6 (8%) | 0.2 |
| Eptifibatide | 4 (5%) | 1 (1%) | 0.17 |
| Sheath size | |||
| 5–6Fr | 40 (54%) | 55 (74%) | 0.01 |
| 7–8Fr | 34 (46%) | 19 (26%) | |
| Closure strategy | |||
| Manual compression | 32 (43%) | 19 (26%) | 0.025 |
| Vascular closure device | 42 (57%) | 55 (74%) | |
| Mean contrast volume (ml) | 214.8 ± 133.6 | 184.6 ± 130.7 | 0.17 |
| Mean procedure duration (min) | 99 ± 92 | 66 ± 48 | 0.008 |
⁎ Number of patients with documentation of an ipsilateral femoral arterial puncture before the index coronary procedure.
| Variable | VCD (n = 6,527) | MC (n = 2,581) | p Value |
|---|---|---|---|
| Significant groin bleeding | 19 (0.29%) | 21 (0.81%) | <0.001 |
| Bleeding by Thrombolysis In Myocardial Infarction criteria | 3 (0.05%) | 5 (0.19%) | 0.03 |
| Hematoma ≥5 cm | 13 (0.20%) | 12 (0.46%) | 0.03 |
| Retroperitoneal bleed | 2 (0.03%) | 2 (0.08%) | 0.33 |
| Femoral arterial perforation | 1 (0.02%) | 2 (0.08%) | 0.85 |
| Pseudoaneurysm | 11 (0.17%) | 9 (0.35%) | 0.1 |
| Vascular occlusion | 7 (0.11%) | 1 (0.04%) | 0.32 |
| Venous thrombosis | 3 (0.05%) | 0 (0%) | 0.27 |
| Arterial occlusion | 4 (0.06%) | 1 (0.04%) | 0.67 |
| Arteriovenous fistula | 4 (0.06%) | 1 (0.04%) | 0.67 |
| Access-site infection | 1 (0.02%) | 0 (0%) | 0.53 |
Patients with an access-site complication were compared in case–control fashion to randomly selected patients without complications. In univariable analyses, patients with complications were older, had a higher frequency of chronic kidney disease, more frequent use of 7Fr to 8Fr femoral sheaths, longer procedures, and a higher rate of manual closure than controls. There were no significant differences between patients with vascular complications and controls in other baseline characteristics ( Table 1 ) and procedural variables ( Table 2 ). Vascular complications were associated with a longer hospital stay. Patients with access-site complications spent an average of 2 additional nights in hospital compared to controls (2.5 ± 2.7 vs 0.4 ± 0.8 days, p <0.001). In multivariate conditional logistic regression of nested case–control subsets, sheath size (odds ratio [OR] 2.46, 95% confidence interval [CI] 1.09 to 5.55) and age (OR 1.04, 95% CI 1.01 to 1.08) were predictors of postprocedure access-site complications ( Table 4 ). A secondary regression model incorporating closure strategy identified a nonsignificant trend toward decreased complications associated with VCD use.
| Model Variables | Adjusted OR (95% CI) | p Value |
|---|---|---|
| Model 1: case–control analysis | ||
| 7–8Fr sheath size | 2.46 (1.09–5.55) | 0.03 |
| Age | 1.04 (1.01–1.08) | 0.01 |
| Model 2: case–control analysis | ||
| 7–8Fr sheath size | 2.25 (0.97–5.19) | 0.06 |
| Age | 1.04 (1.01–1.07) | 0.02 |
| Vascular closure device | 0.60 (0.26–1.37) | 0.22 |
| Model 3: full study population | ||
| Vascular closure device | 0.52 (0.33–0.83) | <0.01 |
| Male gender | 0.66 (0.42–1.04) | 0.07 |
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