|Year : 2022 | Volume
| Issue : 2 | Page : 31-36
Perclose ProGlide devices simplified the removal of the femoral venous cannulas for the transcatheter closure of atrial septal defect: A single-center retrospective study
Xiaofeng Han, Xi Guo, Tiezheng Li, Guangrui Liu
Department of Diagnostic and Interventional Radiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
|Date of Submission||23-Mar-2022|
|Date of Decision||12-Apr-2022|
|Date of Acceptance||16-Apr-2022|
|Date of Web Publication||24-Jun-2022|
Dr. Xi Guo
Department of Diagnostic and Interventional Radiology, Beijing Anzhen Hospital, Capital Medical University, Beijing
Source of Support: None, Conflict of Interest: None
OBJECTIVE: This study aimed to assess the effectiveness, feasibility, and security of the Perclose ProGlide device that was used to remove the femoral venous cannulas for the transcatheter closure of atrial septal defect (ASD).
METHODS: A total of 145 cases were analyzed retrospectively, who performed transcatheter closure of ASD in our center from March 2019 to March 2021. Based on whether the Perclose ProGlide device was placed or not in the femoral vein, 48 patients were assigned to the Perclose group and 97 ones to the non-Perclose group. The data of general characteristics, femoral venous cannulas, and related puncture complications were compared between the two groups.
RESULTS: The data of general characteristics or femoral venous cannulas were not significantly different between the two groups, but the procedure duration of removing venous cannulas was shorter in the Perclose group (0.5 min [0.35, 0.70] vs. 5 min [3.6, 7.4], P < 0.001). The puncture procedure-related blood lose was not significantly different between the two groups (Hemoglobin reduction value: 0.10 [−0.47, 0.30] g/dL vs. 0.10 [−0.50, 0.30] g/dL, P = 0.905). In addition, other complications caused by the removal of venous cannulas, length of stay in the ward, puncture infection, reintervention, and so on were not significantly different between the groups.
CONCLUSIONS: The Perclose ProGlide device could simplify the removal of femoral venous cannulas for ASD transcatheter closure by decreasing procedure duration and time in bed. The efficiency, feasibility, and safety of Perclose ProGlide devices, which were used to remove venous cannulas, are good enough for their clinical application.
Keywords: Atrial septal defect, femoral venous cannula, Perclose ProGlide device, removing cannulas
|How to cite this article:|
Han X, Guo X, Li T, Liu G. Perclose ProGlide devices simplified the removal of the femoral venous cannulas for the transcatheter closure of atrial septal defect: A single-center retrospective study. Vasc Invest Ther 2022;5:31-6
|How to cite this URL:|
Han X, Guo X, Li T, Liu G. Perclose ProGlide devices simplified the removal of the femoral venous cannulas for the transcatheter closure of atrial septal defect: A single-center retrospective study. Vasc Invest Ther [serial online] 2022 [cited 2022 Dec 5];5:31-6. Available from: https://www.vitonline.org/text.asp?2022/5/2/31/348221
| Introduction|| |
Atrial septal defect (ASD) is a common congenital heart disease. Since the first transcatheter closure of ASD was reported in 1974, it has become the first choice for ASD treatment because of its minimal invasion, rapid recovery, few complications, and short hospitalization. In the past, compression was often used for hemostasis in the sites of femoral vein puncture. The common diameter of the introducer sheath through the femoral vein puncture site is 8–14F. The wound compression and postoperative immobilization are time-consuming when the sheath is removed. The Perclose ProGlide device has been widely used for endovascular graft exclusion in the treatment of femoral artery puncture sites. We use this technique in the treatment of femoral vein puncture sites in ASD transcatheter closure. By comparing with conventional compression for hemostasis, we explore the effectiveness, feasibility, and safety of the device. The related report is as follows.
| Materials and Methods|| |
The patients with ASD who were admitted to and performed transcatheter closure in our center from March 2019 to March 2021 were analyzed retrospectively. From March 2019 to May 2020, a total of 97 patients (33 male and 64 female ones) were treated with 5-min compression for hemostasis in their femoral vein puncture sites, after which they lied on their back for 12 h. From May 2020 to March 2021, a total of 48 patients (9 male and 39 female ones) were treated with the Perclose ProGlide device for hemostasis in their femoral vein puncture sites. The inclusion criteria for the ASD patients were as follows: (1) patients who are diagnosed with ASD and significant left-to-right shunt by transthoracic echocardiography and (2) patients who completed venipuncture, transcatheter closure, and extubation. The exclusion criteria were as follows: (1) patients with ostium primium ASD; (2) patients with right-to-left or bidirectional shunt; and (3) patients with a failure of puncture or transcatheter closure and who were transferred to surgery.
Based on the different treatment methods of femoral vein puncture sites and whether the Perclose ProGlide device is used, the patients were divided into a Perclose group and a non-Perclose group. For patients in the Perclose group, only one suture device was used when the femoral vein was catheterized, and the suture line was not tightened but was retained until the transcatheter closure procedure was completed. When the femoral vein delivery sheath was removed, the preset suture line was tightened to suture the femoral vein puncture site. For those in the non-Perclose group, when the femoral vein delivery sheath was removed during their operation, their puncture site was compressed manually for 5 min to achieve the purpose of puncture site hemostasis.
All surgeries were performed in the catheterization laboratory and completed with the assistance of a sonographer using transthoracic echocardiography. The patient was placed in a supine position. Routine disinfection draping was performed in the inguinal region. The Seldinger method was used to puncture the right femoral vein. One Perclose ProGlide device and the arterial sheath were placed in turn. After the completion of the right heart catheterization, the MPA 1 catheter was sent to the superior vena cava. After the hard guide wire was replaced, the delivery sheath was sent to the superior vena cava. According to the results of intraoperative ultrasound measurement, the size of the ASD occluder determined was selected correspondingly. After the air bubbles were removed from the delivery sheath, the delivery cable loaded with occlude was sent until the occluder reached the tip of the delivery sheath. The projection position was changed to 45° left anterior oblique position. The delivery sheath was slowly pulled back to the right atrium from the superior vena cava. With a clockwise torsion angle of 45°, the delivery sheath was twisted to enter the left atrium. The occluder was completely released after it was deployed and the sonographer confirmed that the occlude was in place using transthoracic echocardiography.
Wound treatment after surgery: For patients in the Perclose group, the long introducer sheath was withdrawn, and the preset suture line was tightened directly. After it was confirmed that there was no blood oozing after puncture, the patient was given immobilization for 4 h after returning to the ward with routine bandaging; for patients in the non-Perclose group, the introducer sheath was withdrawn, and the puncture site was compressed for 5 min. After it was confirmed that there was blooding from the wound, pressure bandaging was applied for 8 h, and the patient was given immobilization for 12 h after returning to the ward [Figure 1].
|Figure 1: Schematic diagram of the surgical methods. (1) After 1 Perclose ProGlide device is placed, a 6F sheath is placed; (2) After the delivery sheath is removed, the suture is pushed to suture the puncture site with a push device; (3) After the puncture site is sutured, there is no blood oozing at the puncture site; (4) Wound hemostasis is efficient in case such is seen after the completion of suture; (5) Size of the defect seen by echocardiography during ASD transcatheter closure; (6) What is seen after the occluder is released at the end of the surgery. ASD: Atrial septal defect|
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The basic data (age, sex, and past history), catheterization conditions (sheath diameter and catheterization time), extubation conditions (extubation duration, puncture site complications, time for bed rest, and hospitalization), transcatheter closure conditions (defect diameter [mm] and occluder model [mm]), and other indicators were compared between the two groups.
SPSS 24.0 software (IBM, Armonk, NY, USA) was used for statistical analysis. The measured data in line with normal distribution were expressed as mean ± standard deviation. The t-test or variance test was used for the comparison between the two groups. The measured data not in line with normal distribution were expressed as quartiles. The rank-sum test was used for the comparison between the two groups. The Chi-squared test was used for the comparison of the calculated data between the two groups. P < 0.05 is considered to be statistically significant.
| Results|| |
Comparison of general results
Of the 145 patients included in this study, 48 were in the Perclose group and 97 in the non-Perclose group. The basic situation and catheterization condition are shown in [Table 1]. The duration of extubation hemostasis was 30 s for patients in the Perclose group, which was significantly lower than 300 s for those in the non-Perclose group (P < 0.001)), and the sheath diameters were statistically different. Except the two items above, there was no statistical difference in age, sex, past disease history, or complications related to catheterization and extubation between the two groups.
|Table 1: Comparison of basic information and catheterization condition between the two groups|
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Comparison of extubation
[Table 2] shows the information about extubation in both groups. The differences in the bleeding volume during extubation (hemoglobin values before and after surgery) and incidence of puncture site-related complications such as wound oozing have no statistical significance between the two groups. Patients experienced significantly less time in immobilization in the Perclose group compared to those in the non-Perclose group (12 h vs. 4 h).
|Table 2: Comparison of relevant conditions before and after extubation between the two groups|
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| Discussion|| |
ASD is a common congenital heart disease clinically. At present, interventional occlusion has become the first choice for ASD treatment. On the basis of the traditional operating process, we used the Perclose ProGlide device to improve the hemostasis in puncture sites when the delivery sheath was removed so as to reduce the compression time for wound hemostasis as well as the occurrence of complications in puncture site. This study showed that the application of the Perclose ProGlide device in ASD transcatheter closure can effectively shorten the hemostatic time of extubation wound, and reduce the blood loss during extubation and the immobilization time, without affecting the hospitalization or puncture site-related complications.
The indications and contraindications of the Perclose ProGlide device are not clear when they are used for the femoral vein access procedure for removing the delivery sheath. We learn from the application experience of the preembedding suture technique in endovascular aortic repair (EVAR), transfemoral aortic valve replacement (TAVR), and extracorporeal membrane oxygenation (ECMO),,,,, and the suture requirements for femoral vein are recommended as follows: (1) the suture device is preset at the puncture site, and its diameter should be > 6 mm. However, the diameter of femoral vein is usually larger than that of its accompanying femoral artery. Theoretically, the venous anatomical conditions can meet the requirement of presetting a suture device; but the vein is an organ that stores blood and has less elasticity, so it requires certain skills and a tensile force to be maintained when the needle is inserted in order to avoid the blood vessel wall against being sutured. (2) The anterior wall of the femoral artery at the puncture site requires that calcified lesions are not severe, while femoral vein calcification occurs less frequently. (3) No severe stenosis, ulcer, or dissection occurs in the femoral artery at the puncture site, although they are generally less common for the femoral vein. However, to rule out the condition above, a bedside vascular ultrasound can be performed for femoral vein examination before catheterization. (4) For surgeons who are not skilled in femoral vein puncture surgery, they can perform ultrasound-guided femoral vein puncture and suture with a preembedding device so as to improve the operating accuracy and reduce the occurrence of puncture complications. The success of surgery depends on the correct selection of vascular puncture points through the approach. Avoiding a too high puncture point can reduce the risk of retroperitoneal hematoma during transmural puncture. When the puncture point is too low, there is a smaller vascular diameter that will affect the surgery. The puncture operation can be performed at this level with the fluoroscopy for marking the position of the greater trochanter. There is no venous valve in this region. That is, we selected the same level of 0.5 cm as a median value to the puncture point of the ipsilateral common femoral artery for puncture at the femoral vein puncture point.
Although it has been clinically reported that EVAR can be accomplished by preembedding the Perclose ProGlide device through the transfemoral approach, we usually preembed two devices to let the delivery sheath with a larger diameter go through (>16F) femoral arterial punctures, and even adding a third device if necessary. Unlike the puncture site in EVAR, TAVR, or ECMO, effective hemostasis of femoral puncture sites after puncture can be achieved with only one device (with the model of occluder delivery sheath [8–14F]). Unlike the preembedding and suturing operations for femoral artery puncture, when the suture device is preembedded at the venous puncture site, there is nonpulsatile bleeding in the side hole of the device. However, the side hole is pulsatile bleeding in the arterial puncture. Considering that the venous vessel wall is thin and the elasticity is worse than that of the artery, surgeons should conduct the operation as gently as possible when pulling the suture with the preembedded suture device.
Based on the technical experience in preembedding a device in the femoral artery puncture site, it will neither affect the suture effect of puncture site during extubation nor increase the probability of wound infection to preembed a Perclose ProGlide device at the femoral vein puncture site during ASD transcatheter closure and retain it for a period of time., In this study, 145 patients with ASD, who were admitted to our center over the past 2 years and underwent transcatheter closure, were divided into a Perclose group (n = 48) and a non-Perclose group (n = 97). In the Perclose group, only one device was used, a success rate of 100% and satisfactory results were achieved, and none had puncture site complications such as wound oozing after the operation. There was no statistical difference in the preoperative and postoperative blood loss (hemoglobin difference) between the two groups (P = 0.722). However, when hemostasis was performed in the puncture site, the time for postoperative wound compression was significantly shortened for patients in the Perclose group (P < 0.001). In this study, all the patients needed to be transferred back to the ward from the catheterization laboratory after surgery and frequent movement of the lower limb was inevitable; the suture of the puncture site reduced the risk of wound oozing during such transfer., When patients in the non-Perclose group were transferred back to the ward, 6 (6/97) of these patients had wound oozing, which required rebandaging for hemostasis and increased their time in bed. For patients with large body weight and inability to maintain in a supine position, vagal reflex may occur during compression. As a result, veins were compressed for a long time and there was a possibility for a low blood flow velocity, hematoma, and even pulmonary embolism (PE). The application of Perclose ProGlide devices can significantly reduce the immobilization time of patients after operation (from 12 to 4 h). Patients in the Perclose group had off-bed activities immediately at the 4th h after the surgery, with a good hemostatic effect but without wound oozing. However, one patient in the non-Perclose group returned to the ward after effective hemostasis by a 20 min compression immediately after the surgery because the patient went through coronary PCI 3 months ago and took postoperative anticoagulants (“double antibody” of aspirin + Plavix). These patients had off-bed activities after 12-h immobilization but experienced wound oozing, and their immobilization was prolonged to 24 h.
At present, it is believed that prolonged immobilization of the lower limbs is a possible risk factor for deep vein thrombosis (DVT) in patients. Bad immobilization will slow down the stasis blood flow and cause secondary symptoms such as muscle weakness and atrophy due to prolonged bed rest. Studies have shown that early mobilization of anticoagulated patients with acute DVT is not associated with a higher incidence of new PE, DVT progression, or DVT-related death compared with bed rest, but for patients with moderate or even severe pain, early mobilization has a better prognostic effect for the relief of symptoms. Although the majority of the patients are young in this study, the significantly reduced compression time, reduced risk of wound bleeding during transfer, and less immobilization time can reduce the psychological burden of patients, obtain better hospital feedback, and even play a better role in the prevention of possible risks of lower limb venous thromboembolism.
| Conclusion|| |
Manual compression was mostly used for the hemostasis of postoperative puncture sites in the past, and there was a good effect, but immobilization time was long, which is easy to cause complications such as subcutaneous hematoma and oozing in patients. The wide application of the Perclose ProGlide device not only shortens the postoperative immobilization time but also significantly reduces the incidence of puncture site-related complications in the field of arterial interventional surgeries. As an attempt to apply the Perclose ProGlide device to the venous field, the results of this study show that compared with conventional compression hemostasis of venous puncture sites, there is no significant difference in puncture-related complications, but the postoperative extubation hemostatic time and postoperative immobilization time are significantly reduced. The application of the Perclose ProGlide device in the vein is worthy of clinical promotion.
The research reported has adhered to the relevant ethical guidelines.
The authors thank all patients who participated in this study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]