The Clinical Effectiveness of the Prostar® XL Suture-Mediated Percutaneous Vascular Closure Device for Achievement of Hemostasis

Kenya Nasu, MD, *Etsuo Tsuchikane, MD, **Satoru Sumitsuji, MD, on behalf of the PARADISE Investigators
Kenya Nasu, MD, *Etsuo Tsuchikane, MD, **Satoru Sumitsuji, MD, on behalf of the PARADISE Investigators
Manual compression has been the standard method employed to achieve hemostasis at the arterial puncture site after percutaneous transluminal coronary angioplasty. However, prior studies suggest that major or minor bleeding complications associated with manual compression may occur in over 10% of patients who undergo interventional procedures, which can increase the overall hospital stay by over 2 days, significantly adding to procedural costs.1,2 Furthermore, in an attempt to reduce risks of access site bleeding, other complications can result from interruption of anticoagulation and can again lead to delayed hospital discharge and increased costs. Recently, several new alternatives to achieve hemostasis at the time of arterial sheath removal have been proposed in order to minimize the likelihood of access site complications and to shorten ambulation and hospital stay after interventional therapy.3–10 The Prostar® XL (Perclose, Redwood City, California) allows the femoral arterial puncture site to be percutaneously closed with two nonabsorbable sutures. As shown in the the Early Discharge and Economical effectiveness study for New hemostasis device (EDEN) trial,11 which was previously performed in our country, suture-mediated closure profoundly shortened the time to hemostasis, ambulation and the average length of hospital stay, and decreased the rate of local vascular complications, such as hematoma or false aneurysm. However, the EDEN trial showed that ooze of blood from predilated subcutaneous tissue prolonged time to ambulation. We therefore undertook the Perclose AcceleRated Ambulation and DISchargE (PARADISE) trial, a prospective, non-randomized controlled trial in patients who underwent coronary angioplasty. In this study, we used hydrochloride lidocaine containing 1% epinephrine as local anesthesia to prevent ooze of blood from predilated subcutaneous tissue because effectiveness of epinephrine for hemostasis was shown in the other fields.12–14 The purpose of this study was to assess not only the efficiency and safety of the Prostar® XL, but also the effect of local anesthesia with hydrochloride lidocaine containing 1% epinephrine on the length of ambulation and hospital stay as well as patient comfort compared with the EDEN trial. Methods Study design. The PARADISE trial was a multicenter, non-randomized registry to evaluate the 8 or 10 French (Fr) Prostar® XL device. The inclusion criteria were: 1) patient age from 18–80 years old; 2) patients were not pregnant; 3) catheterization procedure was able to be performed from the femoral approach using 7–10 Fr sheaths; 4) written informed consent was obtained from the patient prior to the inclusion trial; 5) patients were be able to leave the hospital within 24 hours after interventional therapy; and 6) patient was an acceptable candidate for emergent vascular surgical repair. The excluded patients were: 1) patients with known platelet dysfunction or bleeding diathesis; 2) patients enrolled in other clinical trials; 3) patients with intraaortic balloon pumping insertion; 4) patients with acute coronary syndromes; 5) patients who had received the collagen plug hemostasis device; 6) patients with arterial sheath insertion at profounda artery confirmed by angiography of the femoral artery; and 7) patients with clinical or ultrasound evidence of significant peripheral vascular disease, history of vascular surgery, absent pedal pulse, femoral artery bruit, hematoma or pseudoaneurysm. Retrospectively, the times to ambulation and discharge in hours were calculated and compared between the patients in both trials. Study procedure. Following angioplasty, stenting or directional coronary atherectomy using 8 or 10 Fr sheaths as clinically indicated, femoral artery angiography was performed in order to confirm that the puncture was at the common femoral artery, the femoral artery was straight and had no stenosis. If a hematoma developed during the interventional procedure, registry was not performed and the patient was excluded from the study. All eligible patients for this study remained in the laboratory on the catheterization table, where the sheath was removed and the Prostar® XL device was deployed immediately using local anesthesia with hydrochloride lidocaine containing 1% epinephrine. This procedure was performed using the manufacturer’s recommended technique. Post-procedure management called for an initial 1-hour period of bedrest. Patients could elevate their head from 30–45° and turn over, leaving their access leg restrained. After about 1 hour, they were able to sit on the bed without bleeding or oozing from the puncture site. Patients were able to walk after another 2 hours and were discharged the following day unless cardiovascular and peripheral vascular complications occurred. After ambulation, patients who had undergone re-PTCA using femoral access were asked to compare their level of pain from conventional manual compression versus the suture device. Patients who had undergone first PTCA were asked to rate their level of pain during recovery. All patients were asked to determine if manual compression or a suture device was preferred if a repeat intervention was required. Anticoagulation such as heparin on interventional angioplasty was conformed to each site procedure and antithrombotic or anticoagulant agents administered after angioplasty were recorded. Study endpoints and definitions. The primary endpoint was time to hospital discharge, which was calculated as the total time from start of the hemostasis procedure until leaving the hospital. Secondary endpoints were time to device deployment, time to hemostasis, time to ambulation (time to sitting and time to walking were noted, as was distance walked), the incidence of major complications at the femoral access site within the procedure and patient discomfort. Time to deployment was defined as the time elapsed from removal of the arterial sheath until cutting the sutures below the skin level. Time to hemostasis was defined as the time elapsed from removal of the guiding catheter until the achievement of hemostasis. Subcutaneous oozing was treated with an additional 5 minutes of adjunctive compression. Procedural success was defined as complete hemostasis achieved by only the Prostar® XL or with 5 minutes of adjunctive manual compression if needed. Time to sitting was defined as the time elapsed from hemostasis to sitting on the bed without bleeding and time to walking was defined as the time elapsed from the end of device deployment to walking without complications. Peripheral vascular complications were categorized as follows: 1) vascular surgical repair or ultrasound-guided compression for uncontrolled bleeding, large pseudoaneurysm, arteriovenous fistula, femoral artery occlusion due to thrombosis or dissection; 2) rebleeding at the puncture site; 3) femoral nerve injury; 4) infection at the puncture site requiring intravenous antibiotics; 5) small pseudoaneurysm treated medically; and 6) hematoma (0.5–3 cm and > 3 cm). Activated clotting time (ACT) value, hematocrit value and hemoglobin were measured immediately after catheterization and 24 hours later. Follow-up. Patients were examined serially until hospital discharge and signs of femoral puncture site complication were then confirmed by office examination or telephone follow-up at 2–4 weeks post-discharge. Data management and statistical analysis. Case report forms were filled out at each institution. Categorical variables were expressed as frequencies and percentages, whereas continuous variables were expressed as mean values ± standard deviation when appropriate. Results obtained with patients in the PARADISE trial and patients in the EDEN trial were compared using the Kruskal-Wallis test and Mann-Whitney U-test. A 2-sided p-value of 0.05 was considered significant. Results Patient enrollment. Between September 1999 and March 2000, a total of 109 study patients were enrolled. The suture device was successfully placed in 108 of 109 attempts (99%). One device failure was treated with conventional manual compression with no complications. Patient characteristics. The clinical characteristics, interventional procedure and laboratory data are summarized in Tables 1 and 2. There were no significant differences in these baseline characteristics between patients in the PARADISE trial versus the EDEN trial. Nine and 10 Fr size sheaths were used more frequently in the PARADISE trial (p Time to procedure and hemostasis. The procedures were successful in 99% of patients. The times to deployment and hemostasis were significantly shorter in the PARADISE trial patients (p Time to ambulation: Time to sitting. The time to sitting was significantly shorter in the PARADISE patients (p Time to ambulation: Time to walking. The time to walking was also significantly shorter in PARADISE patients (p Time to discharge. The time to discharge was significantly shorter in the PARADISE patients (p Peripheral vascular complications. In this trial, the overall incidence of peripheral vascular complications was quite low while the patients still had full anticoagulation with a prolonged ACT (299 ± 65 seconds). There was a low incidence of major complications (Table 4). No major or minor complications occurred at the time of discharge. Only 1 patient had a small hematoma (Patient survey. Questionnaires were completed by 89 patients (82%). Seventy-eight percent of the patients who underwent interventional therapy via the femoral artery thought the Prostar® XL was comfortable. Eighty-four percent of the first PTCA patients allowed suture device use. Over 90% of the patients would prefer the suture device if a repeat intervention was needed (Table 5). Discussion This multicenter trial showed that the Prostar, a new vascular hemostasis device, reduces time to hemostasis, time to ambulation and time to discharge after angioplasty without increasing the rate of vascular access site complications compared to conventional manual compression. Intensive anticoagulation after angioplasty is important to avoid lethal coronary thrombosis.15,16 However, heparinization after interventional procedures, overlapping oral anticoagulation and antiplatelet therapy have been associated with the incidence of major puncture site bleeding complications.17–21 Furthermore, these procedures have resulted in the prolongation of patient bedrest and length of hospital stay.1,2 Recently, several new approaches have been developed in an effort to achieve more rapid hemostasis at the arterial access site and minimize groin complications.3–10 However, even this device has not significantly decreased complications.22,23 The Prostar® XL device is different because it uses no collagen and relies on direct suture-mediated closure of the arterial puncture site as an alternative hemostasis method. The Prostar enables closure of the femoral artery puncture site percutaneously with two braided, polystar 3-0 nonabsorbable sutures. The main advantage of this device is increased patient comfort and convenience due to shorter bedrest and immobilization. In addition to this procedure, hydrochloride lidocaine containing 1% epinephrine as local anesthesia was able to reduce the ooze of blood from tissue around the puncture site and shorten time to ambulation and discharge. Currently, there is no standard classification scheme for categories of peripheral vascular complications after catheterization.22 In the present study, complications were analyzed as shown in Table 4. There were no significant differences in the incidence of overall complications, but there was a trend toward a lower incidence of overall complications in the PARADISE trial patients compared with the suture device and manual compression groups in the EDEN trial (2.8% versus 6.5% and 7.2%, respectively). There were no major complications after the procedure until discharge. In 1 patient, although ambulation time was 157 minutes without oozing and discharge time was 24 hours, surgical repair was required at follow-up examination for infection of the sutures used to close his femoral puncture site. His systemic condition was good and white blood cell count was 5,600 µl; however, CRP value was 4.3 mg/dl. Pus was oozing out from the puncture site and debridement of subcutaneous tissue was performed. We suspected that the puncture site was infected during the interventional procedure or during placement of the Prostar® XL device. A minor complication (1.5 cm hematoma) was present in 1 patient during the hospital stay. There was one 1.5 cm hematoma at follow-up examination. This complication rate is lower than those reported in previous reports.3,22–25 Previous reports have attributed hematoma formation to sheath size > 8 Fr26,27 and to anticoagulation use;17–21 however, in this trial, oozing from subcutaneous tissue was suspected to be the cause since the hemostasis procedure was successful. Full anesthesia and careful predilatation of subcutaneous tissue may reduce the incidence of minor bleeding complications such as hematomas. The most striking clinical observations with the Prostar® XL device were its ability to rapidly close the arterial puncture site with 2 sutures in just a few minutes and the associated reduction in compression time. The times to procedure completion and hemostasis were significantly reduced versus those observed in comparable patients treated with conventional manual compression in the EDEN trial. These reductions in procedural and hemostasis times were of the same magnitude as those previously reported by using the Prostar® XL or other procedures to obtain hemostasis.3–11,22,23 The time to hemostasis could be significantly shortened regardless of systemic full anticoagulation compared with the manual compression group in the EDEN trial. After hemostasis, sitting was possible after a mean time of 1.8 ± 1.0 hours of bedrest and walking was possible after 3.0 ± 2.4 hours in this trial. They were significantly shorter compared to either group of the EDEN trail and to previous studies.3–5,11,15–23 Within 3 hours, seventy-five percent of patients were able to ambulate. Although the procedure and hemostasis were successful, subcutaneous ooze of blood from subcutaneous tissue was persistent in the early ambulation patients in the EDEN trial. Oozing from the subcutaneous tissue of the puncture site can occur with systemic anticoagulation and antiplatelet therapies after angioplasty because placement of the Prostar® XL device requires a slightly larger skin incision than otherwise. In the PARADISE trial, oozing from subcutaneous tissue of the puncture site was reduced by using hydrochloride lidocaine containing 1% epinephrine as local anesthesia. Patients in this trial were able to leave the hospital 21.6 ± 8.4 hours after sheath removal, which is significantly earlier than patients in either group of the EDEN trial. Within 24 hours, eighty-nine percent of patients were discharged. One previous study29 showed that the Prostar® XL device reduces the hospital cost by shortening hospital stay. This hospital cost and change were not calculated in this study; however, if cost benefits were not cancelled by the actual expense of the Prostar® XL device, it may be estimated that the cost in this study was cheaper than in the previous study because the time to discharge was significantly shorter than in the previous study (21.6 ± 8.4 hours versus 56.0 ± 44.4 hours; p 29 suggested that patient comfort with the suture device was increased using a visual analog scale for the discomfort level. In this trial, ninety-eight percent of patients who underwent previous interventional therapy preferred the Prostar if a repeat intervention was needed; therefore, it is suggested that the Prostar® XL device is as comfortable as a hemostasis device. Conclusion. The suture-mediated percutaneous closure Prostar® XL device appears to be a safe and speedy method to achieve hemostasis at the puncture site despite the high level use of anticoagulation. In spite of earlier ambulation, the incidence of peripheral complications was lower with the suture device compared to conventional pressure. In the present study, the hemostasis time, duration of bedrest and length of hospital stay were substantially shorter than in previous studies because ooze of blood from subcutaneous tissue of the puncture site was able to be reduced using hydrochloride lidocaine containing 1% epinephrine as local anesthesia. There is unquestionable potential for clinical effectiveness and patient comfort associated with its use.
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