Catheterization and Cardiovascular Interventions 87:75–81 (2016)
Comparison of the Boomerang Wire Vascular Access Management System Versus Manual Compression Alone During Percutaneous Diagnostic and Interventional Cardiovascular Procedures:
The BoomerangTM Wire Vascular Access Management Trial II Nilesh J. Goswami,1* MD, Ronnie G. Smalling,2 MD, Shantanu Sinha,3 MD, Roger S. Gammon,4 MD, and Venkatesh G. Ramaiah,5 MD Objectives: To evaluate the use of the BoomerangTM Wire as an adjunct to manual compression (MC) in patients requiring diagnostic (Dx) or interventional (Ix) percutaneous procedures. Background: MC remains the standard of care for closure of femoral artery access sites. Adjunctive use of a device to facilitate closure, reduce time to hemostasis (TTH) and ambulation (TTA) without increasing complication rates could reduce costs and hospital resource demands. Methods: The BoomerangTM Trial was a prospective, multicenter, randomized, controlled trial comparing use of the BoomerangTM wire, (Cardiva Medical, Sunnyvale, CA) in conjunction with MC versus MC alone to achieve hemostasis in Dx and Ix patients undergoing percutaneous procedures requiring femoral artery access. Endpoints included TTH, TTA, major, and minor access-site related complications. Subjects were randomized 3:1, Boomerang versus MC. Results: No minor or major device-related adverse events were reported. Nondevice related complication rates were 3 (0.9%) in the Boomerang arm (n 5 327) and 1 (0.8%) in MC arm (n 5 123). Mean TTH for Boomerang vs. MC was 11.2 6 4.3 vs. 23.2 6 11 min for Dx (P < 0.0001) and 13.9 6 5.4 vs. 38.4 6 57.3 min for Ix patients (P < 0.0001). Mean TTA for Boomerang vs. MC was 3.3 6 3.0 vs. 4.5 6 2.0 hr (P < 0.0001)for Dx and 5.4 6 3.3 vs. 6.8 6 3.2 hr (P < 0.0001) for Ix patients. Conclusions: BoomerangTM use, in conjunction with MC, was associated with low rates of complications and demonstrated that BoomerangTM as an adjunct to MC can significantly decrease TTH and TTA after both Dx and Ix procedures. VC 2015 Wiley Periodicals, Inc. Key words: vascular access; bleeding; closure device
INTRODUCTION
Despite overall improvements in the safety and efficacy of percutaneous procedures, effective and safe management of the arterial puncture site remains an impediment to patient ambulation and/or discharge after diagnostic (Dx) or interventional (Ix) procedures Contract grant sponsor: Grant sponsor: Cardiva Medical, Inc. 1 Interventional Cardiology, St. John’s - Prairie Heart, Springfield, Illinois 2 Interventional Cardiology, Christi Hospital, Pittsburg, Kansas 3 Interventional Cardiology, Fairfield Medical Center, Lancaster, Ohio 4 Interventional Cardiology, Austin Heart, Austin, Texas 5 Vascular Surgery, Arizona Heart Institute, Phoenix, Arizona Conflict of interest: The author would like to disclose that he is a consultant to Cardiva Medical. Disclosures: Nilesh J. Goswami, MD, is a consultant to Cardiva Medical. C 2015 Wiley Periodicals, Inc. V
[1,2]. Improper management of the femoral access site may be implicated in a significant percentage of postprocedure complications. Arteriotomy site hemostasis is most often accomplished via manual compression (MC). This has been considered the “gold standard” for achieving hemostasis since 1953, when Seldinger *Correspondence to: Nilesh J. Goswami, MD, Prairie Cardiovascular Consultants, P.O. Box 19420, Springfield, IL 62794-9420. Email: [email protected] Received 23 November 2013; Revision accepted 10 January 2015 DOI: 10.1002/ccd.25842 Published online 18 February 2015 in Wiley Online Library (wileyonlinelibrary.com)
76
Goswami et al.
first performed percutaneous access of the femoral artery. Although the application of direct pressure at the puncture site does stop bleeding, the body’s coagulation cascade actually does most of the work. After cases utilizing femoral artery access, the patient is generally placed on bedrest anywhere from 2 to 8 hours prior to ambulation and discharge. Vascular closure devices (VCDs) were first developed in the mid-1990s, largely propelled by concerns of increased rates of access site bleeding associated with percutaneous coronary intervention (PCI) procedures [3]. A number of devices have subsequently been developed to assist in achieving postprocedural hemostasis, including clamps, collagen- or gelatin-based plugs, suture-mediated devices, and impregnated patches. Decisions to use these devices for the most part have been made on a case-bycase basis, depending on a patient’s comorbid conditions, anticoagulation state, and often physician preference. Results from the use of these devices have been mixed and MC continues to be the strategy most often used for achieving hemostasis after femoral artery catheterization because of its relative safety and simplicity. The BoomerangTM (Cardiva Medical, Sunnyvale, CA) is a device used to assist in vascular closure. It consists of a nitinol (NiTi) disc that can be deployed inside the artery (through the sheath). The disc is left in place while the arteriotomy has a chance to recoil around the smaller caliber Boomerang (after the sheath is removed; Fig. 1). After a “dwell time,” the disc can be collapsed and the Boomerang wire (BW) can be removed without leaving any foreign body behind. MC is then used as needed to achieve hemostasis. This study reports results of using MC alone or in conjunction with the BoomerangTM Wire Vascular Access Management System in Dx and Ix procedures requiring femoral arterial access.
MATERIALS AND METHODS
The BoomerangTM Wire Vascular Access Management Trial II is a prospective, randomized, multicenter trial for subjects who required a Dx or Ix percutaneous procedure in which MC was indicated for vascular access site management of the femoral artery. Sheath sizes ranged from 5F to 10F. No other active fixation or mechanical pressure devices were allowed. Subjects were randomized to the Boomerang arm or the MC alone arm in a 3:1 ratio. A manual, envelopebased randomization scheme was used after the completion of the procedure. Participants received and signed informed consent forms that were IRB approved. Preprocedure exclusion criteria included the following: sepsis, severe comorbidities that might be life-
Fig. 1. Boomerang is positioned through access sheath. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
threatening within 12 months, other VCD implanted within 90 days, prior clip or suture-based VCD, platelet count 6 cm; late access site related bleeding (following hospital discharge); ipsilateral lower extremity arterial emboli; ipsilateral deep vein thrombosis; access site wound dehiscence; localized access site infection treated with intramuscular or oral antibiotics; arteriovenous fistula not requiring treatment; pseudoaneurysm requiring thrombin injection or fibrin adhesive injection; pseudoaneurysm not requiring treatment; new onset access site related neuropathy in the ipsilateral lower extremity not requiring surgical repair; ipsilateral pedal pulse diminished by two grades or transiently lost. The primary effectiveness endpoint was time to hemostasis (TTH). TTH was defined as the elapsed time between “device” removal, (BW for treatment arm and sheath removal for MC control arm), and verified arterial hemostasis (as evident by absence of pulsatile bleeding, formation of hematoma, or arterial oozing). The secondary effectiveness endpoint was time to ambulation (TTA), defined as elapsed time between hemostasis and when subject stood and walked 20 feet without evidence of arterial bleeding from the access site. The unified protocol specified a consistent post-hemostasis waiting period (2 hr 45 min for Dx patients and 4 hr 90 min for Ix patients) prior to ambulation for both the BW treatment arm and the MC control arm. Statistical Methods
Continuous measures are summarized as mean, standard deviation, median, minimum, and maximum by treatment arm and compared by both t-test (for means) and Wilcoxon’s test (for medians). Binary outcomes are summarized as frequency and proportion and compared by Fisher’s exact test. RESULTS
A total of 450 subjects were enrolled in the Boomerang II Trial from September 1, 2006 to September 14, 2007 at seven sites; 123 patients were randomized and treated with MC only and 327 patients were randomized to the Boomerang arm.
77
Baseline demographics (Table I) were very similar between the treatment and control groups. The mean ages in the Boomerang and MC groups were 64.9 12.1 years, and 65.4 12.3 years, respectively. The percentage of female subjects (44%) was identical in the treatment and control groups. There were no statistically significant differences between the two groups in terms of BMI, rates of hypertension, incidence of diabetes, peripheral vascular disease, or history of cigarette smoking, or renal function. Table I provides a summary of the patient demographics. Heparin was reported to have been administered to 35% of the control patients and 21% of the Boomerang patients (P ¼ 0.004). Table II provides details of anticoagulation both preprocedure and periprocedure. Sheath sizes from 5F to 9F were used. The majority of patients received a 6F sheath (67% BW vs. 62% MC) while 9F sheath sizes were only used in 1% of BW and 2% of MC cases. Sheath sizes were not statistically different between the two groups (P > 0.05). No device related adverse events were reported. There were four major adverse events that were related to the access procedure: 3 (1.5%) in the Dx Boomerang cohort and 1 (1.3%) in the Dx MC control cohort. Two subjects [one Boomerang (0.5%) and one MC] were each diagnosed via ultrasound with small pseudoaneurysms that responded to conservative management. In the Boomerang group, one 72-year-old female on aspirin (ASA) and clopidogrel developed an ipsilateral, ilio-femoral deep vein thrombosis 10 days after the procedure. No hematoma was noted and the patient was successfully treated with mechanical thrombolysis and venous stenting. Another subject in the Boomerang group, a 67-year-old female with a body mass index of 50, required a transfusion secondary to a large hematoma. All subjects resolved events after 30 days without long-term sequelae. The only minor access site related complications reported consisted of hematomas >6 cm. At 3–7 days postprocedure, 3 hematomas > 6 cm were reported: 1 (0.5%) in the Dx Boomerang arm, 1 (1.3%) in the Dx MC arm, and 1 (2.2%) in the Ix MC arm. There was no significant difference among groups (P ¼ 0.18, all patients). All were resolved by the 30-day follow-up. No hematomas > 6 cm were reported in the Ix Boomerang arm. Table III provides safety results. Results of the primary and secondary effectiveness endpoints by treatment group and procedure type are provided in Table IV. There was no significant difference in dwell time between any of the subgroups or between combined (Dx plus Ix) Boomerang group and MC group. The average ACT times measured at the time of sheath removal for the DX cases were 181.7 79.5 for the BW group and 131.1 19.5 for
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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TABLE I. Demographics Dx (N ¼ 266) Boomerang (N ¼ 188)
MC (N ¼ 78)
Age Mean 63.3 12.5 Median 63.6 (31–90) Gender Female 86 46% BMI Mean 31.1 6.2 Median 30.4 (17–54) Hypertension Yes 149 79% Diabetes Yes 52 28% Creatinine (mg/dL) Mean 1.0 0.5 Median 1.0 (0.5–5.3) Peripheral Vascular Disease Yes 24 14% Cigarette Smoker No 149 79%
TABLE II.
Ix (N ¼ 184)
Total (N ¼ 450)
Boomerang (N ¼ 139)
MC (N ¼ 45)
Boomerang (N ¼ 327)
MC (N ¼ 123)
P-value
63.4 64.6
12.8 (34–92
67.2 67.9
11.3 (34–90)
68.9 68.0
10.5 (48–87)
64.9 65.3
12.1 (31–90)
65.4 66.0
12.3 (34–92)
NS NS
37
47%
59
42%
17
38%
145
44%
54
44%
NS
29.0 28.0
5.3 (19–46)
29.3 28.4
5.5 (18–47)
28.7 28.0
5.8 (15–49)
30.3 29.6
6.0 (17–54)
28.9 28.0
5.5 (15–49)
NS NS
53
68%
118
85%
38
84%
267
82%
91
74%
NS
18
23%
47
34%
19
42.2%
99
30%
37
30%
NS
1.0 1.0
0.3 (0.6–2.0)
1.1 1.0
0.6 (0.6–6.4)
1.2 1.0
0.6 (0.4–4.1)
1.1 1.0
0.6 (0.5–6.4)
1.1 1.0
0.4 (0.4–4.1)
NS NS
8
10%
57
41%
18
40%
83
25%
26
21%
NS
62
79%
106
76%
35
78%
255
78%
97
79%
NS
Anticoagulation Dx (N ¼ 266) Boomerang (N ¼ 188)
Aspirin Preprocedure 161 Periprocedure 41 Plavix Preprocedure 41 Periprocedure 3 Coumadin Preprocedure 5 Lovenox Preprocedure 3 Protomine Periprocedure 4 Heparin Periprocedure 8 Angiomax Periprocedure 0 GP IIb/IIIa Inhibitors Periprocedure 0
Ix (N ¼ 184) MC (N ¼ 78)
Boomerang (N ¼ 139)
Total (N ¼ 450) MC (N ¼ 45)
Boomerang (N ¼ 327)
MC (N ¼ 123)
P-value
86% 22%
67 15
86% 19%
119 25
86% 18%
37 9
82% 20%
280 66
86% 20%
104 24
85% 20%
NS NS
22% 2%
11 1
14% 1%
59 36
42% 26%
19 13
42% 29%
100 39
31% 12%
30 14
24% 11%
0.2 NS
3%
4
5%
6
4.3%
2
4%
11
3%
6
5%
NS
2%
2
3%
4
2.9%
0
0%
7
2%
2
2%
NS
2%
2
3%
11
8%
3
7%
15
5%
5
4%
4%
22
28%
62
45%
21
47%
70
21%
43
35%
0%
0
0%
72
52%
24
53%
72
22%
24
20%
NS
0%
1
1%
6
4%
0
0%
6
2%
1
1%
NS
the MC group (P < 0.00001). For IX cases, the measured ACT times were 292.7 81.9 for the BW group and 215.2 74.8 for the MC group (P < 0.00001). Combined Dx and Ix mean TTH was 12.3 4.9 min in the group assigned to Boomerang vs. 28.8 36.3 min in the group assigned to MC (P < 0.0001). For the Dx patients, the mean TTH was 11.2 4.3 min in the
NS 0.004
Boomerang group vs. 23.2 11 min in the MC group (P < 0.0001). For the Ix patients, the mean TTH was 13.9 5.4 min in the Boomerang group vs. 38.4 57.3 min in the MC group (P < 0.0001). Student’s t-test was used to compare the individual site mean TTH times versus the overall mean for the MC arm. The analysis indicated that no institution displayed significantly
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
BW Vascular Access Management System vs. MC TABLE III.
79
Safety Dx (N ¼ 266)
Ix (N ¼ 184)
Total (N ¼ 450)
Boomerang
MC
Boomerang
MC
Boomerang
MC
P-value
(N ¼ 188)
(N ¼ 78)
(N ¼ 139)
(N ¼ 45)
(N ¼ 327)
(N ¼ 123)
Fisher’s exact-test
0 (0%) 3 (1.5%) 1 (0.5%) 1 (0.5%) 1 (0.5%) 1 (0.5%)
– 1 (1.3%) 1 (1.3%) 0 (0%) 0 (0%) 1 (1.3%)
– 0 (0%) 0 (0%) 0 (0%) 0 (0%) 1 (2.2%)
0 (0%) 3 (0.9%) 1 (0.3%) 1 (0.3%) 1 (0.3%) 1 (0.3%)
– 1 (0.8%) 1 (0.8%) 0 (0%) 0 (0%) 2 (1.2%)
N/A 1.00 0.47 1.00 1.00 0.18
Adverse Events Device Related Procedure Related Pseudoaneurysm DVT Transfusion Hematoma > 6 cm
0 0 0 0 0 0
(0%) (0%) (0%) (0%) (0%) (0%)
TABLE IV. Effectiveness Dx (N ¼ 266)
Ix (N ¼ 184)
Total (N ¼ 450)
Boomerang
MC
Boomerang
MC
Boomerang
MC
P-value
(N ¼ 188)
(N ¼ 78)
(N ¼ 139)
(N ¼ 45)
(N ¼ 327)
(N ¼ 123)
t-test/Wilcoxon
26.8 28.4 20 (1–207)
152.4 69.2 136 (42–422)
149.3 67.2 152 (2–285)
79.2 77.9 40 (9–422)
71.6 75.2 32 (1–285)
0.35 0.06
23.2 11 20 (5–58)
13.9 5.4 12 (8–37)
38.4 57.3 27 (10–367)
12.3 4.9 10.5 (4–37)
28.8 36.3 20 (5–367)
Comparison of the Boomerang Wire Vascular Access Management System Versus Manual Compression Alone During Percutaneous Diagnostic and Interventional Cardiovascular Procedures:
The BoomerangTM Wire Vascular Access Management Trial II Nilesh J. Goswami,1* MD, Ronnie G. Smalling,2 MD, Shantanu Sinha,3 MD, Roger S. Gammon,4 MD, and Venkatesh G. Ramaiah,5 MD Objectives: To evaluate the use of the BoomerangTM Wire as an adjunct to manual compression (MC) in patients requiring diagnostic (Dx) or interventional (Ix) percutaneous procedures. Background: MC remains the standard of care for closure of femoral artery access sites. Adjunctive use of a device to facilitate closure, reduce time to hemostasis (TTH) and ambulation (TTA) without increasing complication rates could reduce costs and hospital resource demands. Methods: The BoomerangTM Trial was a prospective, multicenter, randomized, controlled trial comparing use of the BoomerangTM wire, (Cardiva Medical, Sunnyvale, CA) in conjunction with MC versus MC alone to achieve hemostasis in Dx and Ix patients undergoing percutaneous procedures requiring femoral artery access. Endpoints included TTH, TTA, major, and minor access-site related complications. Subjects were randomized 3:1, Boomerang versus MC. Results: No minor or major device-related adverse events were reported. Nondevice related complication rates were 3 (0.9%) in the Boomerang arm (n 5 327) and 1 (0.8%) in MC arm (n 5 123). Mean TTH for Boomerang vs. MC was 11.2 6 4.3 vs. 23.2 6 11 min for Dx (P < 0.0001) and 13.9 6 5.4 vs. 38.4 6 57.3 min for Ix patients (P < 0.0001). Mean TTA for Boomerang vs. MC was 3.3 6 3.0 vs. 4.5 6 2.0 hr (P < 0.0001)for Dx and 5.4 6 3.3 vs. 6.8 6 3.2 hr (P < 0.0001) for Ix patients. Conclusions: BoomerangTM use, in conjunction with MC, was associated with low rates of complications and demonstrated that BoomerangTM as an adjunct to MC can significantly decrease TTH and TTA after both Dx and Ix procedures. VC 2015 Wiley Periodicals, Inc. Key words: vascular access; bleeding; closure device
INTRODUCTION
Despite overall improvements in the safety and efficacy of percutaneous procedures, effective and safe management of the arterial puncture site remains an impediment to patient ambulation and/or discharge after diagnostic (Dx) or interventional (Ix) procedures Contract grant sponsor: Grant sponsor: Cardiva Medical, Inc. 1 Interventional Cardiology, St. John’s - Prairie Heart, Springfield, Illinois 2 Interventional Cardiology, Christi Hospital, Pittsburg, Kansas 3 Interventional Cardiology, Fairfield Medical Center, Lancaster, Ohio 4 Interventional Cardiology, Austin Heart, Austin, Texas 5 Vascular Surgery, Arizona Heart Institute, Phoenix, Arizona Conflict of interest: The author would like to disclose that he is a consultant to Cardiva Medical. Disclosures: Nilesh J. Goswami, MD, is a consultant to Cardiva Medical. C 2015 Wiley Periodicals, Inc. V
[1,2]. Improper management of the femoral access site may be implicated in a significant percentage of postprocedure complications. Arteriotomy site hemostasis is most often accomplished via manual compression (MC). This has been considered the “gold standard” for achieving hemostasis since 1953, when Seldinger *Correspondence to: Nilesh J. Goswami, MD, Prairie Cardiovascular Consultants, P.O. Box 19420, Springfield, IL 62794-9420. Email: [email protected] Received 23 November 2013; Revision accepted 10 January 2015 DOI: 10.1002/ccd.25842 Published online 18 February 2015 in Wiley Online Library (wileyonlinelibrary.com)
76
Goswami et al.
first performed percutaneous access of the femoral artery. Although the application of direct pressure at the puncture site does stop bleeding, the body’s coagulation cascade actually does most of the work. After cases utilizing femoral artery access, the patient is generally placed on bedrest anywhere from 2 to 8 hours prior to ambulation and discharge. Vascular closure devices (VCDs) were first developed in the mid-1990s, largely propelled by concerns of increased rates of access site bleeding associated with percutaneous coronary intervention (PCI) procedures [3]. A number of devices have subsequently been developed to assist in achieving postprocedural hemostasis, including clamps, collagen- or gelatin-based plugs, suture-mediated devices, and impregnated patches. Decisions to use these devices for the most part have been made on a case-bycase basis, depending on a patient’s comorbid conditions, anticoagulation state, and often physician preference. Results from the use of these devices have been mixed and MC continues to be the strategy most often used for achieving hemostasis after femoral artery catheterization because of its relative safety and simplicity. The BoomerangTM (Cardiva Medical, Sunnyvale, CA) is a device used to assist in vascular closure. It consists of a nitinol (NiTi) disc that can be deployed inside the artery (through the sheath). The disc is left in place while the arteriotomy has a chance to recoil around the smaller caliber Boomerang (after the sheath is removed; Fig. 1). After a “dwell time,” the disc can be collapsed and the Boomerang wire (BW) can be removed without leaving any foreign body behind. MC is then used as needed to achieve hemostasis. This study reports results of using MC alone or in conjunction with the BoomerangTM Wire Vascular Access Management System in Dx and Ix procedures requiring femoral arterial access.
MATERIALS AND METHODS
The BoomerangTM Wire Vascular Access Management Trial II is a prospective, randomized, multicenter trial for subjects who required a Dx or Ix percutaneous procedure in which MC was indicated for vascular access site management of the femoral artery. Sheath sizes ranged from 5F to 10F. No other active fixation or mechanical pressure devices were allowed. Subjects were randomized to the Boomerang arm or the MC alone arm in a 3:1 ratio. A manual, envelopebased randomization scheme was used after the completion of the procedure. Participants received and signed informed consent forms that were IRB approved. Preprocedure exclusion criteria included the following: sepsis, severe comorbidities that might be life-
Fig. 1. Boomerang is positioned through access sheath. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
threatening within 12 months, other VCD implanted within 90 days, prior clip or suture-based VCD, platelet count 6 cm; late access site related bleeding (following hospital discharge); ipsilateral lower extremity arterial emboli; ipsilateral deep vein thrombosis; access site wound dehiscence; localized access site infection treated with intramuscular or oral antibiotics; arteriovenous fistula not requiring treatment; pseudoaneurysm requiring thrombin injection or fibrin adhesive injection; pseudoaneurysm not requiring treatment; new onset access site related neuropathy in the ipsilateral lower extremity not requiring surgical repair; ipsilateral pedal pulse diminished by two grades or transiently lost. The primary effectiveness endpoint was time to hemostasis (TTH). TTH was defined as the elapsed time between “device” removal, (BW for treatment arm and sheath removal for MC control arm), and verified arterial hemostasis (as evident by absence of pulsatile bleeding, formation of hematoma, or arterial oozing). The secondary effectiveness endpoint was time to ambulation (TTA), defined as elapsed time between hemostasis and when subject stood and walked 20 feet without evidence of arterial bleeding from the access site. The unified protocol specified a consistent post-hemostasis waiting period (2 hr 45 min for Dx patients and 4 hr 90 min for Ix patients) prior to ambulation for both the BW treatment arm and the MC control arm. Statistical Methods
Continuous measures are summarized as mean, standard deviation, median, minimum, and maximum by treatment arm and compared by both t-test (for means) and Wilcoxon’s test (for medians). Binary outcomes are summarized as frequency and proportion and compared by Fisher’s exact test. RESULTS
A total of 450 subjects were enrolled in the Boomerang II Trial from September 1, 2006 to September 14, 2007 at seven sites; 123 patients were randomized and treated with MC only and 327 patients were randomized to the Boomerang arm.
77
Baseline demographics (Table I) were very similar between the treatment and control groups. The mean ages in the Boomerang and MC groups were 64.9 12.1 years, and 65.4 12.3 years, respectively. The percentage of female subjects (44%) was identical in the treatment and control groups. There were no statistically significant differences between the two groups in terms of BMI, rates of hypertension, incidence of diabetes, peripheral vascular disease, or history of cigarette smoking, or renal function. Table I provides a summary of the patient demographics. Heparin was reported to have been administered to 35% of the control patients and 21% of the Boomerang patients (P ¼ 0.004). Table II provides details of anticoagulation both preprocedure and periprocedure. Sheath sizes from 5F to 9F were used. The majority of patients received a 6F sheath (67% BW vs. 62% MC) while 9F sheath sizes were only used in 1% of BW and 2% of MC cases. Sheath sizes were not statistically different between the two groups (P > 0.05). No device related adverse events were reported. There were four major adverse events that were related to the access procedure: 3 (1.5%) in the Dx Boomerang cohort and 1 (1.3%) in the Dx MC control cohort. Two subjects [one Boomerang (0.5%) and one MC] were each diagnosed via ultrasound with small pseudoaneurysms that responded to conservative management. In the Boomerang group, one 72-year-old female on aspirin (ASA) and clopidogrel developed an ipsilateral, ilio-femoral deep vein thrombosis 10 days after the procedure. No hematoma was noted and the patient was successfully treated with mechanical thrombolysis and venous stenting. Another subject in the Boomerang group, a 67-year-old female with a body mass index of 50, required a transfusion secondary to a large hematoma. All subjects resolved events after 30 days without long-term sequelae. The only minor access site related complications reported consisted of hematomas >6 cm. At 3–7 days postprocedure, 3 hematomas > 6 cm were reported: 1 (0.5%) in the Dx Boomerang arm, 1 (1.3%) in the Dx MC arm, and 1 (2.2%) in the Ix MC arm. There was no significant difference among groups (P ¼ 0.18, all patients). All were resolved by the 30-day follow-up. No hematomas > 6 cm were reported in the Ix Boomerang arm. Table III provides safety results. Results of the primary and secondary effectiveness endpoints by treatment group and procedure type are provided in Table IV. There was no significant difference in dwell time between any of the subgroups or between combined (Dx plus Ix) Boomerang group and MC group. The average ACT times measured at the time of sheath removal for the DX cases were 181.7 79.5 for the BW group and 131.1 19.5 for
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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Goswami et al.
TABLE I. Demographics Dx (N ¼ 266) Boomerang (N ¼ 188)
MC (N ¼ 78)
Age Mean 63.3 12.5 Median 63.6 (31–90) Gender Female 86 46% BMI Mean 31.1 6.2 Median 30.4 (17–54) Hypertension Yes 149 79% Diabetes Yes 52 28% Creatinine (mg/dL) Mean 1.0 0.5 Median 1.0 (0.5–5.3) Peripheral Vascular Disease Yes 24 14% Cigarette Smoker No 149 79%
TABLE II.
Ix (N ¼ 184)
Total (N ¼ 450)
Boomerang (N ¼ 139)
MC (N ¼ 45)
Boomerang (N ¼ 327)
MC (N ¼ 123)
P-value
63.4 64.6
12.8 (34–92
67.2 67.9
11.3 (34–90)
68.9 68.0
10.5 (48–87)
64.9 65.3
12.1 (31–90)
65.4 66.0
12.3 (34–92)
NS NS
37
47%
59
42%
17
38%
145
44%
54
44%
NS
29.0 28.0
5.3 (19–46)
29.3 28.4
5.5 (18–47)
28.7 28.0
5.8 (15–49)
30.3 29.6
6.0 (17–54)
28.9 28.0
5.5 (15–49)
NS NS
53
68%
118
85%
38
84%
267
82%
91
74%
NS
18
23%
47
34%
19
42.2%
99
30%
37
30%
NS
1.0 1.0
0.3 (0.6–2.0)
1.1 1.0
0.6 (0.6–6.4)
1.2 1.0
0.6 (0.4–4.1)
1.1 1.0
0.6 (0.5–6.4)
1.1 1.0
0.4 (0.4–4.1)
NS NS
8
10%
57
41%
18
40%
83
25%
26
21%
NS
62
79%
106
76%
35
78%
255
78%
97
79%
NS
Anticoagulation Dx (N ¼ 266) Boomerang (N ¼ 188)
Aspirin Preprocedure 161 Periprocedure 41 Plavix Preprocedure 41 Periprocedure 3 Coumadin Preprocedure 5 Lovenox Preprocedure 3 Protomine Periprocedure 4 Heparin Periprocedure 8 Angiomax Periprocedure 0 GP IIb/IIIa Inhibitors Periprocedure 0
Ix (N ¼ 184) MC (N ¼ 78)
Boomerang (N ¼ 139)
Total (N ¼ 450) MC (N ¼ 45)
Boomerang (N ¼ 327)
MC (N ¼ 123)
P-value
86% 22%
67 15
86% 19%
119 25
86% 18%
37 9
82% 20%
280 66
86% 20%
104 24
85% 20%
NS NS
22% 2%
11 1
14% 1%
59 36
42% 26%
19 13
42% 29%
100 39
31% 12%
30 14
24% 11%
0.2 NS
3%
4
5%
6
4.3%
2
4%
11
3%
6
5%
NS
2%
2
3%
4
2.9%
0
0%
7
2%
2
2%
NS
2%
2
3%
11
8%
3
7%
15
5%
5
4%
4%
22
28%
62
45%
21
47%
70
21%
43
35%
0%
0
0%
72
52%
24
53%
72
22%
24
20%
NS
0%
1
1%
6
4%
0
0%
6
2%
1
1%
NS
the MC group (P < 0.00001). For IX cases, the measured ACT times were 292.7 81.9 for the BW group and 215.2 74.8 for the MC group (P < 0.00001). Combined Dx and Ix mean TTH was 12.3 4.9 min in the group assigned to Boomerang vs. 28.8 36.3 min in the group assigned to MC (P < 0.0001). For the Dx patients, the mean TTH was 11.2 4.3 min in the
NS 0.004
Boomerang group vs. 23.2 11 min in the MC group (P < 0.0001). For the Ix patients, the mean TTH was 13.9 5.4 min in the Boomerang group vs. 38.4 57.3 min in the MC group (P < 0.0001). Student’s t-test was used to compare the individual site mean TTH times versus the overall mean for the MC arm. The analysis indicated that no institution displayed significantly
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
BW Vascular Access Management System vs. MC TABLE III.
79
Safety Dx (N ¼ 266)
Ix (N ¼ 184)
Total (N ¼ 450)
Boomerang
MC
Boomerang
MC
Boomerang
MC
P-value
(N ¼ 188)
(N ¼ 78)
(N ¼ 139)
(N ¼ 45)
(N ¼ 327)
(N ¼ 123)
Fisher’s exact-test
0 (0%) 3 (1.5%) 1 (0.5%) 1 (0.5%) 1 (0.5%) 1 (0.5%)
– 1 (1.3%) 1 (1.3%) 0 (0%) 0 (0%) 1 (1.3%)
– 0 (0%) 0 (0%) 0 (0%) 0 (0%) 1 (2.2%)
0 (0%) 3 (0.9%) 1 (0.3%) 1 (0.3%) 1 (0.3%) 1 (0.3%)
– 1 (0.8%) 1 (0.8%) 0 (0%) 0 (0%) 2 (1.2%)
N/A 1.00 0.47 1.00 1.00 0.18
Adverse Events Device Related Procedure Related Pseudoaneurysm DVT Transfusion Hematoma > 6 cm
0 0 0 0 0 0
(0%) (0%) (0%) (0%) (0%) (0%)
TABLE IV. Effectiveness Dx (N ¼ 266)
Ix (N ¼ 184)
Total (N ¼ 450)
Boomerang
MC
Boomerang
MC
Boomerang
MC
P-value
(N ¼ 188)
(N ¼ 78)
(N ¼ 139)
(N ¼ 45)
(N ¼ 327)
(N ¼ 123)
t-test/Wilcoxon
26.8 28.4 20 (1–207)
152.4 69.2 136 (42–422)
149.3 67.2 152 (2–285)
79.2 77.9 40 (9–422)
71.6 75.2 32 (1–285)
0.35 0.06
23.2 11 20 (5–58)
13.9 5.4 12 (8–37)
38.4 57.3 27 (10–367)
12.3 4.9 10.5 (4–37)
28.8 36.3 20 (5–367)
