Preclosure of Femoral Vein Access Site With the Suture-Mediated Proglide Device During MitraClip Implantation

Abstract: This study was designed to show the feasibility, safety, and efficacy of venous access-site closure with a single 6 Fr suture-mediated Proglide (Abbott Vascular) during MitraClip procedures. Methods. Preclosure of the right femoral vein with Proglide used for access with the 24 Fr guiding catheter was performed. A total of 72 patients undergoing MitraClip were enrolled in this study (28 patients retrospectively and 44 patients prospectively), of whom 42 patients underwent a groin examination with ultrasound 2 days after the procedure. Results. Only 1 patient (1.4%) needed transfusion of packed cells because of bleeding and hematoma in the groin due to Proglide failure. None of the patients that were examined with ultrasound revealed an arteriovenous fistula or a spurious aneurysm, a local thrombosis, or a local stenosis related to the Proglide device. Conclusion. This study demonstrates that vascular closure with the suture-mediated Proglide system is feasible, safe, and efficacious in large venous sites of 24 Fr as needed in patients undergoing MitraClip implantation despite the necessity of anticoagulation or platelet inhibition.

J INVASIVE CARDIOL 2013;25(10):508-510

Key words: MitraClip, Proglide, venous access closure

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Mitral valve repair by transfemoral MitraClip implantation has recently emerged as a procedure to improve mitral insufficiency in patients for whom surgical mitral valve repair or replacement is not an option.^1-4 During MitraClip implantation, a large transvenous access is required with a 24 Fr guiding catheter in the femoral vein. Severe groin complications associated with these large venous access sites are much less common than after arterial puncture. Yet, if severe bleeding occurs, this may be associated with the need for transfusion and with a delay of mobilization and prolonged hospital stay.⁴ The present study was designed to show the feasibility, safety, and efficacy of preclosure of the venous access site after MitraClip therapy with one single 6 Fr Proglide device.

Methods

Patients. Pre closure of the venous access site was performed with the 6 Fr Proglide vascular closure system (Abbott Vascular) in 72 consecutive patients undergoing MitraClip therapy at the Department of Cardiology and Pneumology of the University Medical Centre Göttingen. Twenty-eight patients were enrolled retrospectively and 44 patients were enrolled prospectively. All patients were treated with dual-antiplatelet inhibition or with oral anticoagulation plus single-antiplatelet inhibition where appropriate. Patients gave written informed consent.

Groin management during MitraClip procedure. For groin management, the thread of one suture-mediated 6 Fr Proglide device (Abbott Vascular) was positioned into the femoral vein prior to cannulation and placement of the 24 Fr guiding catheter. The shaft of the 6 Fr Proglide device was placed inside the femoral vein according to the manufacturer’s instructions for use in arteries. If venous pressure was not sufficient to give adequate blood back through the telltale port, the device was passed as far as possible into the vein in order to ensure proper deployment of the apparatus in the lumen of the vein. Then, MitraClip therapy was performed as previously described.^1-4 After removal of the clip delivery system and the 24 Fr guide at the end of the procedure, the femoral vein access site was closed with the thread. In addition, two single cutaneous suture knots were used. All patients were supplied with a compression bandage for 6-12 hours after intervention. After removal, all patients received a clinical groin examination. We looked for clinical signs of bleeding, hematoma, arteriovenous fistula, and spurious aneurysm. Forty-two patients received an additional groin examination with ultrasound by measuring the ipsilateral and contralateral femoral vein to exclude local stenosis or local thrombosis and a color Doppler ultrasound to exclude arteriovenous fistula or spurious aneurysm. 

Results

Patient characteristics and concomitant treatment. A total of 72 patients were enrolled into this study; 44 patients (61%) were male and 28 patients (39%) were female. The age ranged from 46-89 years (mean age, 76 ± 8 years). The patients presented with abundant comorbidities, which was reflected by a high logistic EuroScore of 28 ± 3%. A total of 97.7% of patients received aspirin. A dual platelet inhibition with aspirin plus clopidogrel and low-dose heparin for prophylaxis of thrombosis was given in 31.8% of patients and full-dose anticoagulation with unfractionated or low-molecular-weight heparin was given in 61.3% of patients. 

Bleeding and complications. Severe or life-threatening bleeding according to GUSTO⁵ (with intracerebral hemorrhage or resulting in substantial hemodynamic compromise requiring treatment) was not observed in the present study (0.0% of patients). Moderate bleeding according to GUSTO (requiring blood transfusions but not resulting in hemodynamic compromise) occurred in 6 patients (8.3%). Mild bleeding according to GUSTO (with hematoma or bleeding not meeting the above criteria) occurred in 25 patients (34.8%). When considering only bleeding complications at the access site and related to groin management, no severe or life-threatening bleedings (0.0%), 1 moderate bleeding complication necessitating transfusion (1.4%), and 25 mild bleeding complications (34.8%) were observed. One of these latter patients also had a temporary lymphedema, but did not need any surgical intervention and was discharged from hospital within 5 days. Out of 5 patients with moderate bleeding not related to the access site, 3 patients suffered from preexisting chronic anemia and received transfusions because of blood loss during intervention, 1 patient had gastrointestinal bleeding (1.4%), and 1 patient had bleeding of unknown origin. The latter patient did not show any pathological findings on ultrasound examination of the groin or the retroperitoneal space. None of the patients developed a compartment syndrome or needed a surgical intervention because of a groin complication. There was no significant relationship of bleeding events with hemodynamics at the time of closure.

Ultrasound examination. Forty-two patients underwent an additional groin examination with ultrasound. None of these patients showed an arteriovenous fistula or a spurious aneurysm, a local thrombosis, or a local stenosis. In men, the mean diameter of the right femoral vein that was used for access was 1.1 ± 0.2 cm, versus the left vein with a mean diameter of 1.1 ± 0.2 cm. In women, right and left femoral veins showed mean diameters of 1.0 ± 0.2 cm each. 

Mobilizations and length of hospital stay. Mobilization was intended within 24 hours after intervention. The mean immobilization time was 15.7 ± 5.7 hours after intervention; in 68.2% of patients the immobilization was 12 hours or less. The mean hospital stay was 5.7 ± 3.5 days. One patient died because of severity of his disease, but not because of interventional or groin complications. 

Discussion

The present study demonstrates for the first time that preclosure of the femoral vein with a single Proglide system, which is a suture-mediated vascular closure system, is feasible, safe, and efficacious in large venous access sites up to 24 Fr, despite the necessity of anticoagulation and platelet inhibitors and despite an increased preexisting bleeding risk related to the advanced age and comorbidities of the patient population. Ultrasound examination excluded arteriovenous fistula, spurious aneurysm and local stenosis in the area of the stitch. Yet, 1 patient (1.4%) needed transfusion of packed cells because of bleeding on the groin. In patients without immediate hemostasis after Proglide closure, additional manual compression should therefore be performed. Moreover, patients with elevated venous pressures and postprocedure anticoagulation require closer monitoring. For the majority of patients (68.2%), the immobilization was 12 hours or less. Due to the high-risk nature and advanced age of the patient population, immobilization time was not only related to groin management but also to the overall condition of the treated patient population.

Vascular closure devices are commonly used in arterial access sites in order to achieve earlier hemostasis and earlier mobilization, as well as to avoid manual compression and the use of personnel resources.⁶ Closure devices are less commonly used in venous access sites, but safety and efficacy regarding early hemostasis and mobilization of the Proglide device as a means of closing venous access sites up to a 14 Fr sheath size have been outlined in several reports.^7-12 Deployment of the device yielding sufficient hemostasis has proven to be feasible at the end of the procedure with intermediate sheath sizes, but failed in 1 out of 2 patients after removal of 14 Fr sheaths.⁷ In contrast, the majority of investigators have used the preclosure technique, where the device is deployed before the large sheath is inserted.^8-12 All these investigators have used the Perclose device (Abbott Vascular), which is the predecessor of the Proglide device that has been used in the present study. One study¹³ has used the Angio-Seal device (St Jude Medical), which is available in 6 and 8 Fr and yielded effective hemostasis after routine right heart catheterization. However, this device is not appropriate for preclosure and not available for larger sheath sizes.

The information on groin management in MitraClip trials and studies is sparse. In the landmark EVEREST II trial, transfusion of blood ≥2 units was necessary in 13% of patients,¹ but the origin of the bleeding was not further detailed and the technique of groin management was not explained. In both TRAMI² and ACCESS EU,³ bleeding complications were observed in 3.9% of patients. Again, no further information was given for groin management. In an early report from the EVEREST phase I clinical trial, manual or pneumatic compression using the FemoStop device has been used without any late bleeding.¹⁴ However, this technique needs prolonged compression, which is uncomfortable to the patient and to the nurse. In our own patient cohort, preclosure of the femoral vein with one Proglide was used starting with patient #80. In a previous paper from our group, we reported on outcomes of patients #1 through #75.⁴ In those latter patients, a subcutaneous “figure-of-eight” suture¹⁵ was performed to achieve hemostasis. Severe bleeding after this suture occurred in 4% of patients and moderate bleeding occurred in 13.3% of patients.⁴ Thus, bleeding events were numerically higher than after preclosure with Proglide. However, those events have been considered to be at least partly related to the overall learning curve of patient management because there was a significant decline in bleeding events when consecutive patients were regarded. The “figure-of-eight” suture might be a cost-efficient alternative to preclosure with Proglide, but it may be challenging in cases where there is minimal subcutaneous tissue and also it is difficult to use if arterial and venous sheaths are used simultaneously. Moreover, a randomized study is needed to compare different venous closure techniques with respect to safety and efficacy.

Study limitations. The major shortcoming of the present study is the absence of a control arm and of standardized endpoints. To date, standardized endpoints for percutaneous mitral valve repair have indeed not yet been clearly defined by an expert committee in contrast to, for example, the Valve Academic Research Consortium criteria for transcatheter aortic valve implantation studies.¹⁶

Conclusion

Closure devices will most likely be used more often in veins as transvenous techniques for structural heart disease with large sheaths such as MitraClip are rapidly propagating. The present study demonstrates that this approach is feasible, safe, and efficacious. Yet, it should be realized that these devices are used to save time, but it is uncertain whether they will save complications. Future trials with a clear definition of endpoints, such as hematoma, bleeding, arteriovenous fistula, infection, or pseudoaneurysm, are mandatory.

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