Vascular Access Site Management in High-Risk Patients
Use of a new suture closure device is associated with high procedural success and low rates of bleeding.
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The incidence of access-related bleeding using conventional compression techniques after sheath removal during diagnostic and interventional procedures has been variable. Higher rates of bleeding have been reported during coronary interventional procedures (especially antegrade common femoral arterial access). This study examines the results of a new-generation, percutaneous, suture-mediated closure system used by a single, high-volume interventionalist in a consecutive series of patients.
Between April 2001 and March 2003, 652 consecutive nonrandomized patients undergoing diagnostic and/or therapeutic coronary or peripheral percutaneous catheter-based procedures performed by a single operator at two hospitals were treated with the Perclose Closer, Closer S, or the Perclose A-T (Abbott Vascular Devices, Redwood City, CA) suture-mediated closure systems. The majority (89%) of patients were treated with the 6F Closer or Closer S device. The device was used to close femoral arterial access sites after use of 5 to 8F sheaths. The 6F Closer S was also used to close the femoral arterial access sites for ipsilateral antegrade access sites during interventional peripheral procedures in a limited number of patients.
Device success was defined as the ability to achieve hemostasis with the Perclose device only. Device failures were treated with conventional manual and mechanical compression techniques. Exclusion criteria included common femoral artery of <5 mm, puncture at a site other than the common femoral artery, and heavy calcification. Major complications included hematoma >6 cm, pseudoaneurysm, retroperitoneal bleed, transfusion, surgical repair, and infection.
DEVICE AND DEPLOYMENT TECHNIQUE
The Perclose A-T (Figure 1) is deployed following the manufacturer recommendations. The device is deployed at the end of the procedure by backloading the sheath over a standard .038-inch (or smaller) guidewire and advanced over the wire until the elbow, or bend, enters the artery, indicating proper positioning for the next step, which was suture deployment. By depressing the plunger, the needles are released from the handle of the device. The needles exit the device and travel through the subcutaneous tissue track, pierce the arterial wall, and retrieve the suture. Once needle and suture engagement takes place, the needles are pulled back out of the body with the suture end attached and a pre-tied surgical knot delivered to the arteriotomy site (Figure 2). The suture tail is pulled taught to eliminate any remaining slack from the knot. A gated suture trimmer is loaded onto the suture tail and used to further aid in positioning the knot directly over the arteriotomy. Access site hemostasis is tested in the laboratory by performing a Valsalva maneuver. Once hemostasis is achieved and corroborated, the suture trimmer is used to cut the suture below the skin’s surface (Figure 3).
Patients routinely receive prophylactic oral antibiotics for 48 to 72 hours. Patients undergoing diagnostic angiography were allowed to ambulate after 1 to 2 hours of bed rest. Patients undergoing coronary and/or peripheral interventional procedures were allowed to ambulate after 1 to 2 hours or, if glycoprotein (GP) IIb/IIIa platelet inhibitors were used, after 12 hours.
The device was deployed with an overall success rate of 94.3%. The cumulative success rate of deployment was slightly higher for the first 100 patients compared with the remaining procedures (98% and 93.7%, respectively). Procedures included coronary and peripheral diagnostic arteriography (35%) and both coronary and peripheral intervention (38% and 27%, respectively). Adjunctive GP IIb/IIIa platelet inhibitors were used in 61% of coronary interventional procedures.
Despite the procedural diversity and relatively frequent use of GP IIb/IIIa platelet inhibitors during interventional procedures, relatively low rates of major adverse events were observed. The cumulative major complication rate in this consecutive series was 1.3%, including bleeding (0.5%), infection (0.3%), surgery (0.3%), and pseudoaneurysm (0.3%). The device was unsuccessfully deployed in one of the two patients who developed an infection. The only other infection occurred in a patient who had successful closure after coronary arteriography and developed a postoperative groin infection 3 weeks after elective coronary artery bypass surgery.
The Closer S was used to close 11 antegrade femoral arterial accesses for complex peripheral interventional procedures. An overall success rate of 91% (10 of 11) was achieved.
The newest-generation Perclose system (Perclose A-T) was used in 72 procedures and was successfully deployed in 71 patients (98.6%) without any complications. As described previously, this device automatically ties the knot, simplifies the deployment procedure, and significantly reduces the deployment time. Using the Perclose A-T may prove to result in higher success rates.
Previous reports of hemorrhagic complications related to arterial access have been variable. Duffin et al reported a 13% bleeding rate using an earlier-generation Perclose device.1 Hemorrhagic event rates for the Angio-Seal (St. Jude Medical, Inc., St. Paul, MN) device ranged from 5% to 13% for diagnostic and coronary interventional procedures, respectively. Carere et al2 reported an overall complication rate of 30.5% among 204 patients treated with the VasoSeal device (Datascope Corporation, Mahwah, NJ) after PTCA. More importantly, Cura et al reported a cumulative complication rate of 4.34% in 346 patients treated with previous-generation Perclose devices (1.44% minor and 2.9% major).3 This same study reported a 5% event rate among 220 patients treated with Perclose and a GP IIb/IIIa platelet inhibitor (1.36% minor and 3.64% major complications).
The results of this study, which used the newer-generation Perclose devices in a consecutive series of 652 patients, and combined coronary and peripheral diagnostic and intervention procedures, compare favorably with earlier studies. Both the cumulative event rate and bleeding rate with these newer-generation devices were lower in comparison with the results of earlier studies. The low bleeding rate during coronary intervention occurred even though the majority of patients were treated with GP IIb/IIIa platelet inhibitors. Finally, although only a limited number of antegrade common femoral artery access sites were treated with the Closer S, the results are encouraging. The device success for this cohort was 91%. The vascular and hemorrhagic event rates for antegrade access have historically been quite high (up to 20% in selected series) using manual and mechanical compression.
The use of new-generation suture closure devices after coronary and peripheral diagnostic or interventional procedures is associated with an acceptably low rate of vascular access site bleeding complication. Reliable hemostasis can be achieved regardless of GP IIb/IIIa platelet inhibitor usage. Additionally, early ambulation, as witnessed in this study, permits faster discharge when compared to the cohort of patients who receive manual compression. Further randomized evaluation is necessary to determine if the devices result in a reduction in complication when compared to standard compression methods. The results from this high-volume, single-operator study, however, demonstrate a trend toward a reduction in complication when compared with the rates previously published in the literature.
Thomas M. Shimshak, MD, is an interventional cardiologist at The Ohio Heart Health Center, The Christ Hospital and Bethesda North Hospital, Cincinnati, Ohio. He holds no financial interest in the products mentioned herein. Dr. Shimshak may be reached at (513) 792-7800; Shimshak01@sprintpcs.com.
1. Duffin DC, Muhlstein JB, Allison SB, et al. Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invasive Cardiol. 2001;13:354-362.
2. Carere RG, Webb JG, Miyagishima R, et al. Suture closure of femoral arterial puncture sites after coronary angioplasty followed by same-day discharge. Am Heart J. 2000;139:52-58.
3. Cura FA, Kapadia SR, L’Allier PL, et al. Safety of femoral closure devices after percutaneous coronary interventions in the era of glycoprotein IIb/IIIa platelet blockade. Am J Cardiol. 2000;86:780-782.