Abstract
Background
The Cardiva BoomerangTM is a device used to perform femoral vascular closure. It facilitates passive hemostasis at the arteriotomy site, leaving no residual foreign body.
Methods
We performed a controlled, randomized study of 60 patients undergoing percutaneous coronary intervention. Patients were randomized into two groups (30 per group) to undergo vascular closure with the BoomerangTM or the PercloseTM suture-based device after the intravenous administration of protamine sulfate. We compared overall success rates, patient-reported pain, length of time to achieve hemostasis and mobilization of the patient, and the frequency of complications in the two groups.
Results
Overall success rates using the BoomerangTM and PercloseTM devices were similarly high, at 93% and 97%, respectively. The BoomerangTM was significantly quicker to deploy than the PercloseTM, device deployment time, median (Q1-Q3), [2.00 (1.33-2.75) vs. 3.84 (2.75-4.38) mins, p < 0.001)]. The pain score was significantly lower in the BoomerangTM group (1.1 ± 1.7 vs. 6.4 ± 2.9, p < 0.001). The time the device remained in the artery and manual compression time were significantly longer with the BoomerangTM (p < 0.001), as well as the time taken to achieve hemostasis and time to ambulation. There were no major complications in either group and no significant differences between the groups in the frequency of minor complications.
Conclusions
We conclude that when used in combination with intravenous protamine sulfate, the BoomerangTM device is as safe and effective as the PercloseTM device for femoral vascular closure, but quicker to deploy and less painful to patients.
Keywords: Boomerang, Percutaneous intervention, Vascular closure device
INTRODUCTION
Manual compression is the classic method for achieving hemostasis at the puncture point of the femoral artery after cardiac catheterization. However, complications and long periods of patient bed rest are major drawbacks of manual compression.1,2 Vascular closure devices incorporating sutures, collagen plugs, or nitinol clip mechanisms have been developed to improve the efficacy, safety, and efficiency of hemostasis procedures after cardiac catheterization.3-8 Suture-based closure devices, such as the PercloseTM, facilitate percutaneous coronary intervention (PCI) and early post-procedural mobilization.9 Vascular closure devices must be reliable and easy to use, with an overall safety profile equal to or better than that of manual compression.10-13 However, there is currently no device that fulfills all of these criteria.14,15 The PercloseTM closure device is effective in achieving post-intervention hemostasis, but severe pain can occur when the knot is pushed down onto the artery. The Cardiva BoomerangTM, a vascular closure device, facilitates physiologic closure of the femoral arteriotomy site. Temporary hemostasis is achieved using intravascular tamponade, and no residual foreign body remains at the arteriotomy site. However, the manufacturer recommends that the device remains within the artery for 2 hours after PCI, or until the effects of heparin have completely subsided. Time to ambulation is thus prolonged to approximately 5-6 hours. We designed a new protocol for use of the BoomerangTM in patients undergoing PCI, in which we administered protamine sulfate to reverse the effects of heparin. The aim of our study was to determine the safety and efficacy of the BoomerangTM device when used in combination with protamine sulfate, in comparison to the PercloseTM device.
METHODS
We conducted a single-center, controlled, randomized study at the Department of Cardiology, Changhua Christian Hospital. We studied 60 patients undergoing PCI between December 2009 and March 2010. The patients were randomized at a ratio of 1:1 to undergo femoral vascular closure with the BoomerangTM device (group A) or the PercloseTM device (group B). Angiography and vascular closure were performed immediately after PCI. The study protocol had been approved by the ethics committee of the institution. Informed consent was obtained from all patients prior to the study initiation.
We followed the standard pre-procedural protocol before performing PCI; this involved the administration of loading doses of 300 mg plavix and 300 mg aspirin. Heparin was administered intravenously at a dose of 7500-10000 units to maintain the activated clotting time (ACT) at ≥ 300 s. The PCI was performed via the right femoral artery with a 7-Fr sheath. After PCI, angiography was performed at the puncture site, and was followed by deployment of the vascular closure instrument using either the BoomerangTM or PercloseTM device. The manufacturer’s guidelines for the BoomerangTM device recommend that the device remains within the artery for 2 hours after PCI, when the ACT usually exceeds 180 s. We administered protamine sulfate intravenously to accelerate reversal of the heparin effect. Patients with ACT > 400 s or an interventional procedure time ≤ 1 h received 20 mg protamine sulfate, whereas those with ACT ≤ 400 s or a procedural time > 1 h received 15 mg protamine sulfate. The ACT was checked 10 min after the initial administration of protamine sulfate, and an additional 5 mg dose was given if it remained at ≥ 180 s (Figure 1). Both closure devices were deployed as soon as the ACT fell to < 180 s.
Figure 1.
Deployment of the BoomerangTM device. ACT, activated clotting time; PCI, percutaneous coronary intervention.
We excluded patients with “double wall” arterial punctures, intraluminal thrombi, pseudoaneurysms, hematomas, arteriovenous (AV) fistulas or infection in the target artery lesion, history of protamine allergy, or those who had previously received injections of neutral protamine hagedorn (NPH). We also excluded patients who required a long sheath (≥ 23 cm).
Deployment of the BoomerangTM device
The BoomerangTM closure device (Cardiva Medical Inc., Sunnyvale, CA, USA) comprises a sterile disposable wire and clip. After the completion of PCI and once the ACT was < 180 s, the BoomerangTM wire was inserted through the existing introducer sheath. We deployed the distal tip of the wire to open the flat, low profile disc within the lumen of the femoral artery. After removing the introducer sheath, the disc was then pulled back and positioned against the inside of the intima to seal the arteriotomy. The wire was positioned gently upwards, and tension was maintained by the clip placed on the surface of the skin. The wire was designed to remain in place in the artery for 30 mins. After removing the wire, we applied manual compression to close the remaining needle puncture site. Patients were confined to bed for 120 min after hemostasis was achieved (Figure 1).
Deployment of the PercloseTM device
The PercloseTM (Abbott Laboratories, Abbott Park, IL, USA) is a suture-based device. Needles loaded with non-absorbable surgical suture materials were passed through the vessel wall via a guide wire to form a suture knot on the surface of the artery. After hemostasis was achieved, only bandage compression was needed. Patients were confined to bed for 120 min after this procedure (Figure 2).
Figure 2.
Deployment of the PercloseTM device. ACT, activated clotting time; PCI, percutaneous coronary intervention.
Primary study endpoints
Procedure success
We considered the procedure successful if hemostasis was achieved with 5 min of additional manual compression and the patient became ambulant within 2 h.
Device success
We considered the device effective if we were able to deploy it without failure or cross-over to manual compression, and if hemostasis was achieved without major complications.
Device deployment time
This was the total length of time required to deploy the device.
Device dwell time
This was the total length of time that the device remained in the artery once deployed.
Manual compression time
We defined this as the time taken to achieve hemostasis by manual compression of the femoral artery puncture point after withdrawal of the sheath.
Time to ambulation
This was defined as time taken for the patient to become ambulant after the completion of PCI.
Pain score
We assessed pain by asking patients to score their pain levels on a scale of 0-10, where 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain.16
Major complications
We defined major complications as the need for vascular repair, bleeding requiring transfusion, or infection requiring hospitalization.
Minor complications
We defined minor complications as hematoma > 6 cm in size, AV fistula, renewed bleeding (requiring > 5 min additional manual compression), pseudoaneurysm, or cross-over to manual compression.
Statistical analysis
We compared values in groups A and B using the two-tailed t-test to compare continuous data, Fisher’s exact test and Mann-Whitney test to compare dichotomous data. Multiple logistic regression was used for multivariate analysis.
RESULTS
Patient demographics
The full study population comprised 60 patients with a mean age of 66.5 ± 10.8 years, of whom 68.3% were male. Group A patients were 70.0% male, with a mean age of 63.1 ± 9.9 years; group B patients were 66.7% male, with a mean age of 69.8 ± 10.6 years (Table 1).
Table 1. Characteristics of the patients by study group, and p values for between-group comparisons.
| Group A (BoomerangTM) (n = 30) | Group B (PercloseTM) (n = 30) | p value | |
| Male (n, %) | 21.0, 70.0 | 20.00, 66.7 | 0.78 |
| Age (years)* | 63.1 ± 9.9 | 69.8 ± 10.6 | 0.01 |
| Height (cm)* | 161.8 ± 7.3 | 158.8 ± 12.4 | 0.25 |
| Weight (kg)* | 67.1 ± 11.1 | 65.8 ± 9.0 | 0.64 |
| BMI* | 25.5 ± 3.4 | 26.7 ± 7.2 | 0.43 |
| DM (n, %) | 15.0, 50.0 | 11.0, 36.6 | 0.3 |
| HTN (n, %) | 23.0, 76.6 | 22.0, 73.3 | 0.77 |
| Hyperlipidemia (n, %) | 14.0, 46.6 | 10.0, 33.3 | 0.3 |
| Smoking (n, %) | 7.0, 23.3 | 8.0, 26.6 | 0.77 |
| ESRD (n, %) | 6.0, 20.0 | 1.0, 3.3 | 0.04 |
| CKD (n, %) | 2.0, 6.6 | 3.0, 10.0 | 0.64 |
| CVA (n, %) | 3.0, 10.0 | 0.0, 0.0 | 0.08 |
* Results presented as mean ± SD. BMI, body mass index.
Comparison of endpoints in groups A and B
Patients in group A reported significantly lower pain levels compared with patients in group B (1.10 ± 1.71 vs. 6.40 ± 2.92; p < 0.001) (Table 2). There were no significant differences between the BoomerangTM or the PercloseTM devices in terms of the overall success rate of the device for the femoral closure procedure (93% vs. 97%) (Table 4).
Table 2. Pain scores (number, % patients), average pain score ± SD, and p values for between-group comparisons.
| Pain score | Group A(BoomerangTM) (n = 30) | Group B(PercloseTM) (n = 30) | p value |
| 0 (no pain) | 16.0, 53.3 | 0.0, 0.0 | |
| 1-3 (mild pain) | 11.0, 36.6 | 6.0, 20.0 | |
| 4-6 (moderate pain) | 2.0, 6.6 | 8.0, 26.6 | |
| 7-10 (severe pain) | 1.0, 3.3 | 16.0, 53.3 | |
| Average score | 1.1 ± 1.7 | 6.4 ± 2.9 | < 0.001 |
The length of time taken to deploy the device was significantly shorter for the BoomerangTM than with the PercloseTM device (p < 0.001). However, the total dwell, residual and manual compression times were significantly longer with the BoomerangTM (p < 0.001), as were the total time required to achieve hemostasis (p < 0.001) and the time required for the patient to become ambulant (p < 0.001) (Table 3).
Table 3. Study outcomes and p values for between-group comparisons.
| N | Mean | SD | Median | Q1 | Q3 | Min | Max | N | Mean | SD | Median | Q1 | Q3 | Min | Max | p value | |
| Age | 30 | 63.13 | 9.92 | 64.00 | 54.75 | 71.00 | 44.00 | 78.00 | 30 | 69.87 | 10.65 | 69.00 | 62.50 | 76.75 | 45.00 | 89.00 | 0.025 |
| Height (cm) | 30 | 161.86 | 7.39 | 163.00 | 156.00 | 165.00 | 147.00 | 180.00 | 30 | 158.82 | 12.47 | 159.00 | 152.00 | 167.25 | 108.00 | 177.00 | 0.321 |
| Weight (kg) | 30 | 67.10 | 11.19 | 66.25 | 58.60 | 73.50 | 43.00 | 90.00 | 30 | 65.89 | 9.09 | 63.75 | 58.75 | 75.00 | 52.70 | 81.50 | 0.701 |
| BMI | 30 | 25.54 | 3.40 | 24.95 | 24.03 | 27.55 | 16.18 | 34.72 | 30 | 26.70 | 7.29 | 25.59 | 24.42 | 28.09 | 19.03 | 61.73 | 0.515 |
| Systolic pressure (mmHg) | 30 | 154.60 | 23.10 | 155.50 | 135.75 | 169.50 | 111.00 | 200.00 | 30 | 152.20 | 31.06 | 147.50 | 128.75 | 178.00 | 105.00 | 219.00 | 0.535 |
| Diastolic pressure (mmHg) | 30 | 69.90 | 13.01 | 70.00 | 63.00 | 76.00 | 37.00 | 98.00 | 30 | 68.93 | 12.54 | 68.00 | 57.00 | 76.25 | 50.00 | 97.00 | 0.437 |
| Heparin loading dose (units) | 30 | 7926.67 | 2033.16 | 7500 | 5750 | 10000 | 5000 | 10000 | 30 | 8266.67 | 1869.60 | 7500 | 7500 | 10000 | 5000 | 15000 | 0.742 |
| Protamine given 1st (mg) | 30 | 22.00 | 5.00 | 23.00 | 19.50 | 25.00 | 10.00 | 30.00 | 30 | 22.03 | 4.41 | 23.00 | 18.00 | 25.00 | 10.00 | 28.00 | 0.929 |
| Protamine given 2nd (mg) | 7 | 4.43 | 1.51 | 5.00 | 3.00 | 5.00 | 3.00 | 7.00 | 4 | 8.25 | 2.36 | 9.00 | 5.75 | 10.00 | 5.00 | 10.00 | 0.024 |
| Protamine given total (mg) | 30 | 23.03 | 5.31 | 24.00 | 19.75 | 27.25 | 10.00 | 32.00 | 30 | 23.13 | 4.67 | 23.50 | 20.00 | 25.25 | 15.00 | 36.00 | 0.858 |
| ACT at initial (min) | 30 | 3.09 | 0.70 | 3.02 | 2.46 | 3.68 | 1.97 | 4.63 | 30 | 3.21 | 0.79 | 2.98 | 2.76 | 3.44 | 1.88 | 5.25 | 0.762 |
| ACT as protamine given final (min) | 30 | 2.88 | 0.48 | 2.98 | 2.46 | 3.08 | 1.97 | 3.85 | 30 | 3.06 | 0.47 | 2.98 | 2.76 | 3.44 | 1.88 | 3.80 | 0.258 |
| ACT at removal (min) | 30 | 2.87 | 0.48 | 2.98 | 2.46 | 3.08 | 1.97 | 3.85 | 30 | 3.06 | 0.47 | 2.98 | 2.76 | 3.44 | 1.88 | 3.80 | 0.196 |
| Pain score | 30 | 1.10 | 1.71 | 0.00 | 0.00 | 2.00 | 0.00 | 7.00 | 30 | 6.40 | 2.92 | 7.00 | 4.75 | 8.25 | 1.00 | 10.00 | < 0.001 |
| Device deployment time (min) | 30 | 2.25 | 1.35 | 2.00 | 1.33 | 2.75 | 0.55 | 5.67 | 30 | 4.41 | 2.92 | 3.84 | 2.73 | 4.38 | 1.45 | 16.33 | < 0.001 |
| Device dwell time (min) | 30 | 30.91 | 3.33 | 30.00 | 30.00 | 31.25 | 24.43 | 45.00 | 30 | 0.51 | 0.92 | 0.00 | 0.00 | 0.85 | 0.00 | 2.72 | < 0.001 |
| Device residual time (min) | 30 | 33.15 | 3.60 | 32.19 | 31.33 | 35.17 | 26.43 | 46.00 | 30 | 4.91 | 2.76 | 4.31 | 3.60 | 5.21 | 1.45 | 16.33 | < 0.001 |
| Manual compression time (min) | 30 | 6.92 | 3.70 | 5.00 | 5.00 | 9.25 | 0.17 | 17.68 | 30 | 3.10 | 5.79 | 1.00 | 0.33 | 3.17 | 0.17 | 30.00 | < 0.001 |
| Time to hemostasis (min) | 30 | 40.07 | 4.04 | 38.95 | 37.16 | 42.62 | 32.85 | 48.23 | 30 | 8.02 | 7.23 | 5.57 | 4.31 | 7.85 | 2.50 | 35.50 | < 0.001 |
| Time to ambulation (min) | 30 | 167.03 | 13.49 | 120.00 | 120 | 120 | 120 | 1440 | 30 | 135.53 | 12.89 | 120 | 120 | 130 | 120 | 450 | < 0.001 |
p-value by Mann-Whitney U Test.
Q1, Percentile 25; Q3, Percentile 75; IQR (Interquartile-Range) = Q1-Q3.
There were no major complications in either group. Seven patients in group A and six patients in group B suffered minor complications, but there were no significant differences between the groups (Table 4). Multivariate analysis showed that patients who had CVA and used a high dose of heparin more easily developed hematoma > 6 cm. Patients in the PercloseTM group more easily developed repeat bleeding and required 5 min additional compression (Table 5).
Table 4. Success rate, minor complications (n, % patients) and p values for between-group comparisons.
| Group | ||||||||||
| Boomerang (n = 30) | Perclose (n = 30) | Total (n = 60) | p value | |||||||
| N | % | N | % | N | % | |||||
| Device success | No | 2 | 6.7 | 1 | 3.3 | 3 | 5 | 1 | ||
| Yes | 28 | 93.3 | 29 | 96.7 | 57 | 95 | ||||
| Procedure success | No | 2 | 6.7 | 1 | 3.3 | 3 | 5 | 1 | ||
| Yes | 28 | 93.3 | 29 | 96.7 | 57 | 95 | ||||
| Hematoma > 6 cm | No | 26 | 86.7 | 30 | 100 | 56 | 93.3 | 0.11 | ||
| Yes | 4 | 13.3 | 0 | 0 | 4 | 6.7 | ||||
| Repeat bleeding requiring 5 min additional compression | No | 29 | 96.7 | 24 | 80 | 53 | 88.3 | 0.1 | ||
| Yes | 1 | 3.3 | 6 | 20 | 7 | 11.7 | ||||
| Conversion to manual compression | No | 28 | 93.3 | 30 | 100 | 58 | 96.7 | 0.49 | ||
| Yes | 2 | 6.7 | 0 | 0 | 2 | 3.3 |
p value by Fisher's Exact Test.
Table 5. Results of multiple logistic regression.
| Complication | Predictors | β | SE | OR | 95% C.I. | p value | |
| Hematoma > 6 cm | Age | 0.047 | 0.076 | 1.048 | 0.903-1.217 | 0.54 | |
| Gender | Male | 1 | |||||
| Female | 1.982 | 1.739 | 7.261 | 0.240-219.596 | 0.25 | ||
| Weigh | -0.058 | 0.088 | 0.944 | 0.794-1.122 | 0.51 | ||
| Systolic pressure (mmHg) | -0.051 | 0.036 | 0.951 | 0.886-1.021 | 0.16 | ||
| Heparin loading dose (units) | 0.001 | 0 | 1.001 | 1.000-1.001 | 0.046 | ||
| CVA | No | 1 | |||||
| Yes | 4.112 | 2.028 | 61.045 | 1.146-3251.040 | 0.043 | ||
| Constant | -2.193 | 9.541 | 0.112 | 0.82 | |||
| Repeat bleeding requiring 5 min additional compression | Age | -0.071 | 0.056 | 0.932 | 0.835-1.039 | 0.2 | |
| Group | Boomerang | 1 | |||||
| Perclose | 3.47 | 1.581 | 32.143 | 1.450-712.721 | 0.028 | ||
| ESRD | No | 1 | |||||
| Yes | 1.8 | 1.654 | 6.05 | 0.236-154.836 | 0.28 | ||
| DM | No | 1 | |||||
| Yes | 1.859 | 1.038 | 6.42 | 0.839-49.102 | 0.07 | ||
| Constant | -1.049 | 2.981 | 0.35 |
OR, adjusted odds ratio.
DISCUSSION
We developed a new protocol for the use of the BoomerangTM device that was designed to overcome difficulties associated with the length of time the device is required to be maintained within the artery. Our approach involves the intravenous administration of protamine sulfate to reverse the effects of heparin after interventional catheterization. To our knowledge, this is the first study to use this approach to reduce the procedure time when using the BoomerangTM closure device for femoral closure. In our study population, this approach not only shortened the manufacturer’s recommended procedure time (on average we completed the whole hemostasis procedure within 40 min, a decrease of at least 67%), but patients also reported lower levels of pain compared to those who underwent closure using the PercloseTM device. In addition, there was no damage to the immediate or surrounding tissues during deployment of the device, and patients were more at ease during the procedure. Our new protocol was also successful in 93% of our study population.
The total procedure time and time to ambulation were longer with the BoomerangTM than the PercloseTM device, which is probably due to differences in the design of the two devices - the PercloseTM is a suture-based device, while the BoomerangTM is a mechanical device that requires time for physiological response from the human body in order to be effective. Thus, with the BoomerangTM, the standard procedure is for the device to remain in the artery for 30 min during arteriotomy site tamponade and hemostasis. However, the BoomerangTM is much easier to manipulate than the PercloseTM and thus is quicker to deploy.
No major complications occurred using either device. Several patients developed a hematoma > 6 cm with the BoomerangTM device (13.3% vs. 0%), but the incidence of this and other minor complications was not significantly greater than with the PercloseTM. These results are probably related to the moderation of the effects of heparin by the protamine sulfate, or to the reduced dwell time for the BoomerangTM device. Besides, multivariate analysis showed that patients who had CVA and used a higher dose of heparin were more likely to develop hematoma > 6 cm. Further modifications to our approach might reduce the incidence of hematomas when using the BoomerangTM device; these might include performing repeat checks of the ACT before removing the wire, increasing the time that the wire remains in situ, or avoiding use of the BoomerangTM device in patients with CVA who used a higher dose of heparin. In our study, we also found that using the PercloseTM device itself seemed to cause repeat bleeding and required 5 mins of additional compression. (Table 5). This might be due to the fact that the PercloseTM device had less device residual time (mean 4.91 vs. 33.15 mins) which causes reduced arteriotomy site and surrounding tissue passive hemostasis. Additionally, oozing from the surrounding tissue or direct arteriotomy site leakage may occur more frequently.
Protamine sulfate is the only agent currently used to reverse the effect of heparin. However, it is known to have potentially adverse effects, including potentially life-threatening complication such as hypotension, cardiac suppression, bradycardia, and desaturation. Thomas et al. have analyzed the safety of protamine sulfate in peripheral vascular intervention and found that protamine sulfate-related adverse effect accounted for 4.0~5.3%, which can be managed promptly. Also, those study results also indicated that there were only a few protamine-related deaths (0.02~0.03%).17 If used promptly, protamine sulfate is safe in reversal of the heparin effect. In coronary intervention, several studies have documented that reversal of the anticoagulant effect of heparin after coronary stent implantation is an accepted practice.18,19 Nonetheless, several case reports have announced that protamine sulfate usage immediately after coronary drug eluting stent deployment may cause acute stent thrombosist.20,21 Recently, a retrospect study has showed that it may be safe to use protamine sulfate to reverse the heparin effect after coronary drug eluting stent deployment.22 In our study, no acute stent thrombosis developed after protamine sulfate administration.
Our study does have limitations. One limitation of our study was that it was performed as a single center study in a relatively small study population, and thus our results may be subject to bias. The study only presented preliminary data of a modified protocol for usage of the BoomerangTM device. However, the actual results call for larger-scale clinical trials to clarify, and the long-term safety/efficacy needs to be determined by clinical follow up.
CONCLUSIONS
For femoral vascular closure using the BoomerangTM device after percutaneous coronary intervention, the administration of intravenous protamine sulfate can reduce the time taken to complete hemostasis. This approach is equally effective and safe as compared with the PercloseTM device, and the BoomerangTM is easier to deploy, and causes less patient discomfort. Intravenous administration of protamine sulfate after percutaneous coronary intervention does not appear to be associated with any adverse effects in our study.
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