Venous Access Closure Using the Double-ProGlide Preclose Technique After MitraClip Implantation: Long-Term Clinical and Duplex Ultrasound Outcomes

Abstract: Objective. This study evaluates the safety and efficacy of the double-ProGlide preclose technique to secure hemostasis in patients with 24 Fr venous access. Methods. Consecutive patients with severe mitral regurgitation undergoing the MitraClip procedure were included. All patients underwent the double-ProGlide preclose technique for closure of the femoral vein access site. Duplex ultrasound was performed at 1 month to 1 year after the procedure. The primary study outcome was a composite of major vascular complications, including: (1) the presence of >50% stenosis of the femoral vein; (2) presence of proximal deep vein thrombosis (DVT); and (3) significant venous bleeding as evidenced by >1 unit packed red blood cell transfusion within 48 hours of the procedure. Results. A total of 42 patients (age, 72.5 ± 9.8 years; 26 males) were included. The device was successfully deployed in all cases with successful hemostasis. No transfusions were required and no major vascular complications were noted. Thirty-five patients (83%) underwent duplex ultrasound. No femoral vein stenosis was noted on duplex ultrasound. Conclusions. Off-label use of the double-ProGlide preclose technique after MitraClip therapy for closure of large-caliber femoral vein sites is both safe and efficacious.

J INVASIVE CARDIOL 2016;28(2):40-43. Epub 2015 November 15.

Key words: access-site management, vascular access, structural heart disease, vascular closure devices

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The MitraClip (Abbott Vascular) is a catheter-based device designed to perform an edge-to-edge reconstruction of the insufficient mitral valve while the heart is beating as an alternative to conventional surgery in patients who meet indications for surgical repair.¹ The guide catheter used in this device therapy is 24 Fr and approximately 8 mm in diameter. At the end of the procedure, hemostasis is achieved at the femoral venous access site by manual pressure, sutures, or percutaneous devices such as the Perclose ProGlide (Abbott Vascular). The use of the ProGlide device in a preclose fashion for femoral arterial access has been described systemically since 2002.² While this technique is an on-label use of the device for the femoral artery, it has also been used off label for large femoral venous access sites. Limited data exist to support short-term safety in large veins.^3-6 There are theoretical concerns about risk of vessel stricture and resultant deep vein thrombosis (DVT). In patients who are treated with subcutaneous suture techniques (as opposed to direct venous sutures), such as “figure-8”sutures, there are similarly limited data.⁷ In the published literature, few studies include routine duplex ultrasound of the femoral venous access site in all cases.^4,8 Furthermore, there are concerns that the smaller reported vein sizes in Asians may translate to greater risks in this population.⁹ According to the manufacturer’s manual, the ProGlide device is currently only indicated for use in 5-21 Fr common femoral artery access sites (up until April 2013, only 5-8 Fr access sites were indicated). The aim of this study was to describe the short-term and long-term safety and feasibility of using two 6 Fr ProGlide devices in a “preclose” technique to obtain hemostasis of the femoral venous access site in patients who underwent MitraClip implantation. 

Methods

This is an observational, registry-based, single-center cohort study of all MitraClip patients treated with the ProGlide device using the preclose technique. In all patients, right femoral venous access was obtained using standard techniques. Ultrasound-guided puncture was not used, although fluoroscopy was used to confirm that the puncture was within the area demarcated by the lower two-thirds of the femoral head. Arterial access was obtained on the radial artery or the left femoral artery for invasive blood pressure monitoring. There were no cases in which ipsilateral femoral arterial access was obtained. Internal jugular venous access may also be obtained at the discretion of the anesthesiologist. Bleeding complications from the arterial or internal jugular access sites were included in the measurement of bleeding outcomes. The MitraClip procedures were all performed according to standard techniques. Patients were clinically examined for access-site complications immediately after the procedure, the day after the procedure, prior to discharge, and at 1-month follow-up exam. In particular, patients were examined for active bleeding, hematoma formation, and pain. Duplex ultrasound was used to examine the femoral vein at a median of 129 days (interquartile range, 70-238 days) after the procedure. Duplex ultrasound was also performed in patients who had the procedure performed up to 1 year preceding the approval of this study. Patients had to provide informed consent for participation in this study, and the study protocol was approved by the Institutional Review Board. 

The primary study outcome was a composite of major vascular complications including the following: (1) the presence of >50% stenosis of the femoral vein (at the puncture site); (2) presence of proximal DVT, defined as DVT proximal to and/or involving the superficial femoral vein in the treated leg; and (3) significant venous bleeding, as evidenced by >1 unit packed red blood cell transfusion within 48 hours of the procedure. Secondary outcome measures included bleeding requiring manual pressure hold >5 minutes and distal DVT. We also documented the presence of small hematomas, defined as hematomas requiring some form of intervention such as manual compression or sutures, but not requiring blood transfusions or causing a hemoglobin drop ≥3 g/dL. Minor bleeding was similarly defined as bleeding requiring some form of intervention such as manual compression or sutures, but not requiring blood transfusions or causing a hemoglobin drop ≥3 g/dL.

The preclose technique, which uses two 6 Fr ProGlide devices, has been well described in the literature (Figure 1).^4,10 All operators were familiar with the use of the ProGlide device from prior usage in the femoral artery. Following access-site closure, a light compression bandage was used for 6 hours. Because the MitraClip procedure was performed under general anesthesia, and in view of the large-bore venous access, the procedural protocol required bed rest for at least 6 hours after the procedure. For patients who were previously on anticoagulation therapy (eg, for atrial fibrillation), this was reinstated the day after the procedure. Patients were maintained on dual-antiplatelet therapy according to the instructions for use of the MitraClip device. Antibiotic prophylaxis according to institutional practice was given perioperatively prior at the time of induction of general anesthesia and continued for 2 days. 

Statistical analysis. As this is a descriptive study in a single cohort of patients, statistical analysis was limited to descriptive analysis with medians and interquartile ranges reported for continuous variables and percentages shown for categorical variables. All analyses were performed with SPSS version 18 (SPSS, Inc).

Results

Between April 2011 and March 2014, a total of 42 patients provided informed consent and were enrolled in the study. One additional patient was excluded from this analysis because of arterial access complications requiring surgical repair. Table 1 shows their baseline characteristics, New York Heart Association class, type of mitral regurgitation, and procedural characteristics. Duplex ultrasound study was performed between day 3 and day 364 post procedure, at a median of 129 days (interquartile range, 70-238 days) in 35 patients (83%). The cases with early ultrasound were performed for minor bleeding or hematoma formation to exclude any vascular complications. There were none detected by the duplex studies. 

Table 2 shows the main findings of the study. The device was successfully deployed in all cases. The primary outcome measure of any major vascular complications did not occur in any patients. No transfusions were required. Secondary outcome events occurred in 6 patients (14.3%). Two patients had a small hematoma requiring manual compression and 1 patient had oozing requiring superficial sutures. Two patients had distal DVT (1 acute partial thrombosis in the soleal vein and 1 chronic partial thrombosis in the popliteal, posterior tibial, and peroneal veins). One patient had both a small hematoma (requiring manual compression) and distal DVT (acute partial thrombosis in the soleal vein). There were no cases of pulmonary embolism or venous stenosis. On follow-up ultrasound, there was no significant difference in the diameter of the right compared with the left femoral vein (10.0 ± 1.7 mm vs 9.8 ± 1.9 mm; P=.28). There were no bleeding complications or hematomas from other access sites (eg, radial artery, left femoral artery, or internal jugular vein). 

Discussion

This study provides important information on the short-term and medium-term safety of the use of the ProGlide device with a preclose technique for large venous access. 

In particular, the use of duplex ultrasound to examine the femoral vein after 1 month confirms the belief that this technique does not result in the development of DVT or venous stenosis. Furthermore, despite the smaller size of the common femoral vein in Asians,⁹ our paper shows that the technique is safe and efficacious.  

While the ProGlide device has been approved for use in the arterial system, it is not indicated for use in the venous system. The literature has limited studies on the use of the ProGlide device for large-bore venous sheaths using the preclose technique. In 2008, Mahadevan et al included patients with venous sheaths >10 Fr and did not have any MitraClip procedures or any sheaths >14 Fr.⁵ Nonetheless, the authors reported 99% procedural success, with bleeding as a major complication in 2 out of 146 patients. The use of a single device was initially described by Feldman et al for ~14 Fr sheath size in mitral valvotomy procedures.³ For the MitraClip guide, the preclose technique for venous hemostasis has been described using a single ProGlide device by Ruter et al. The authors reported 72 patients treated in this manner, with 1 patient (1.4%) who had bleeding requiring blood transfusion, and 25 patients (34.8%) who had minor bleeding complications.⁶ In their subset of patients with duplex ultrasound, there were no cases of venous thrombosis or stenosis. Geis et al also described the use of the ProGlide preclose technique using a single device in MitraClip patients. Of their 40 patients, a total of 5 patients (12.5%) required blood transfusions.⁴ In their study, the authors also retrospectively compared their ProGlide experience against the figure-8 suture technique.⁴ They found that 92.5% of patients had immediate hemostasis and 1 patient had an arteriovenous fistula that required surgical repair. Of note, the duplex ultrasound studies were performed 1 day after the MitraClip study. Given the 24 Fr size of the MitraClip guide, which translates to approximately 8 mm, we thought it unlikely that one device would be sufficient to appose the vessel wall. Furthermore, the instructions for the ProGlide do not recommend a single device for sheaths larger that 8 Fr. In our clinical experience, after deployment of the first ProGlide, there would still be some bleeding. With these considerations, our practice has been to use two devices in such large-bore venous sheaths, with excellent safety outcomes. 

The Ruters et al study also reported that the mean diameter of the common femoral vein was 11 mm in men and 10 mm in women.⁶ This is compared to a mean diameter of 10 mm in all patients in our study. Although a direct comparison is not possible given potential differences in technique, this finding is consistent with other reports suggesting a smaller common femoral vein diameter in Asians.⁹ Again, our present study suggests that the preclose technique is safe in Asians, despite the smaller femoral vein size. 

In the present study, there were no occurrences of major vascular complications. However, there were 4 cases of minor bleeding (9.5%), which were conservatively managed. In this study, we aimed to study the longer-term effects of the use of the ProGlide device in a large vein. Hence, the duplex studies were mostly performed between 1 month and 1 year. No cases showed any evidence of venous stenosis. There were 3 distal DVTs that were thought to be unrelated to the procedure given their distal nature. 

Study limitations. This study should be interpreted in the context of its limitations. First, the study did not mandate a precise date for the follow-up duplex ultrasound study. However, the studies were performed between 1 month to 1 year after the MitraClip procedure, which is consistent with the intent of the study to determine longer-term safety. A few cases had the duplex ultrasound performed earlier than 1 month for clinical indications, such as the presence of a hematoma. Second, the number of patients enrolled in this study was small. Despite this, the absence of any significant safety signals was reassuring. Third, the study showed that 9.5% of patients had minor bleeding. However, this was not associated with any pseudoaneurysm formation or transfusions. Given the size of the MitraClip guide, this is probably an acceptable minor complication. 

Conclusion

In summary, this study confirms that the double-ProGlide preclose technique for securing hemostasis in large-caliber venous access sites after MitraClip therapy is both safe and efficacious.

References

1.    Feldman T, Foster E, Glower DG, et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011;364:1395-1406.

2.    Bhatt DL, Raymond RE, Feldman T, et al. Successful “pre-closure” of 7 Fr and 8 Fr femoral arteriotomies with a 6 Fr suture-based device (the Multicenter Interventional Closer Registry). Am J Cardiol. 2002;89:777-779.

3.    Feldman T. Percutaneous suture closure for management of large French size arterial and venous puncture. J Intervent Cardiol. 2000;13:237-242.

4.    Geis NA, Pleger ST, Chorianopoulos E, Muller OJ, Katus HA, Bekeredjian R. Feasibility and clinical benefit of a suture-mediated closure device for femoral vein access after percutaneous edge-to-edge mitral valve repair. EuroIntervention. 2015;10:1346-1353.

5.    Mahadevan VS, Jimeno S, Benson LN, McLaughlin PR, Horlick EM. Preclosure of femoral venous access sites used for large-sized sheath insertion with the Perclose device in adults undergoing cardiac intervention. Heart. 2008;94:571-572.

6.    Ruter K, Puls M, von der Ehe K, et al. Preclosure of femoral vein access site with the suture-mediated ProGlide device during MitraClip implantation. J Invasive Cardiol. 2013;25:508-510.

7.    Cilingiroglu M, Salinger M, Zhao D, Feldman T. Technique of temporary subcutaneous “figure-of-eight” sutures to achieve hemostasis after removal of large-caliber femoral venous sheaths. Catheter Cardiovasc Interv. 2011;78:155-160.

8.    Bagai J, Brilakis ES. Preclosing large venous sheaths with perclose can facilitate advanced structural heart interventions. Catheter Cardiovasc Interv. 2013;81:591.

9.    Fronek A, Criqui MH, Denenberg J, Langer RD. Common femoral vein dimensions and hemodynamics including Valsalva response as a function of sex, age, and ethnicity in a population study. J Vasc Surg. 2001;33:1050-1056.

10.    Yeo KK, Rogers JR. Venous access management. In: Atlas of Percutaneous Edge-to-Edge Mitral Valve Repair. Feldman T, Franzen O, eds. Springer, London; 2013:131-145.

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From the ¹Department of Cardiology, National Heart Centre Singapore, Singapore; and ²Duke-NUS Graduate Medical School, Singapore.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Yeo discloses speaker fees and proctoring fees from Abbott Vascular. The remaining authors report no conflicts of interest regarding the content herein. 

Manuscript submitted May 4, 2015, provisional acceptance given June 18, 2015, final version accepted July 9, 2015.

Address for correspondence: Dr Khung Keong Yeo, 5 Hospital Drive, Singapore 169609, Singapore. Email: yeo.khung.keong@nhcs.com.sg