Catheterization and Cardiovascular Interventions 75:488–492 (2010)
‘‘Double Wire’’ Angio-Seal Closure Technique After Balloon Aortic Valvuloplasty Quang T. Bui,
MD,
Daniel M. Kolansky, MD, FSCAI, Amr Bannan, and Howard C. Herrmann,* MD, FSCAI
MD,
Objectives: To report the feasibility of a collagen-mediated closure device using a modified Angio-Seal closure technique for access site management following percutaneous balloon aortic valvuloplasty (BAV). Background: With the advent of percutaneous aortic valve replacement therapies, there has been a resurgence of interest in BAV procedures. Vascular complications, including bleeding, are a common source of morbidity post procedure as a result of the requirement for large bore femoral artery access. The use of vascular closure devices may reduce bleeding complications. Methods: We describe a new technique for vascular closure in this setting. At the conclusion of the valvuloplasty procedure, two 0.03500 wires are inserted through the femoral artery sheath. A conventional collagen-mediated closure device (8F Angio-Seal) is deployed over the first wire and along side the second wire. If immediate hemostasis is not achieved, a second device is loaded onto the second wire and deployed to achieve hemostasis. Results: Percutaneous BAV was performed in 21 patients. Hemostasis was successfully achieved in all patients with either a single 8F Angio-Seal closure device (18 patients) or after placement of a second device (three patients). Conclusions: The modified ‘‘Double Wire’’ Angio-Seal technique is a feasible method for hemostasis C 2009 Wiley-Liss, Inc. V following percutaneous BAV. Key words: COMP, complications adult cath/intervention; VALV, valvular; heart disease; CLOS, closure; vascular access
INTRODUCTION
The natural history of untreated calcific aortic stenosis is poor [1]. Surgical aortic valve replacement is the gold standard for treatment and the only effective measure to alter the natural history of the disease [2]. In the late 1980s, percutaneous balloon aortic valvuloplasty (BAV) was initially met with enthusiasm as a possible alternative to surgery, especially in the elderly and high-risk surgical population [3]. However, the lack of long term efficacy and durability of this procedure has limited its use to palliative situations [4–6]. The recognition that symptomatic aortic stenosis often goes untreated in 30–60% of patients [7,8] coupled with the emergence of percutaneous aortic valve implantation [9] has led to a resurgence of interest in percutaneous BAV. These procedures are increasingly being performed as temporizing measures for patients awaiting valve implantation, immediately prior to valve implantation, or as medical therapy in conjunction with trials of percutaneous aortic valve implantation. BAV requires femoral artery access using large sheaths and carries a significant risk of vascular complications, including bleeding, which results in signifiC 2009 Wiley-Liss, Inc. V
cant morbidity post procedure [10,11]. Previous techniques for the management of large bore arterial access include manual compression or the use of suture mediated closure techniques. With the intention to simplify access management post procedure, we developed a modified technique to close 9-12F femoral arteriotomies using one or more 8F Angio-Seal collagen based closure devices (St. Jude Medical. St. Paul, MN). Its use and effectiveness in sealing defects larger than 8F have, to our knowledge, not been previously reported.
Cardiovascular Division, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania Conflict of interest: Nothing to report. *Correspondence to: Howard C. Herrmann, MD, FSCAI, 9 Gates Pavilion, 3400 Spruce Street, Philadelphia, PA 19104, USA. E-mail:
[email protected] Received 31 August 2009; Revision accepted 15 September 2009 DOI 10.1002/ccd.22295 Published online 23 November 2009 in Wiley InterScience (www.interscience.wiley.com)
‘‘Double Wire’’ Angio-Seal Closure Technique
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TABLE I. Patient Characteristics and Procedural Data n ¼ 21
Fig. 1. Modified ‘‘Double Wire’’ Angio-Seal technique. At the conclusion of the valvuloplasty procedure, two wires are inserted through the 10F femoral artery sheath. A conventional collagen-mediated closure device (8F Angio-Seal) is deployed along side the second 0.03500 wire (1A). If adequate hemostasis is not achieved, a second device is loaded onto the second wire and deployed to achieve adequate hemostasis (1B). [Color figure can be viewed in the online issue, which is available at www.interscience.wiley.com.]
Patient characteristics Age (mean SD in years) Range (in years) Male Female Hypertension Diabetes Serum creatinine (mean SD mg/dL) Range (in mg/dL) Coronary artery disease Prior coronary artery bypass surgery NYHA Class III/IV Left ventricular EF (mean SD in %) Range (in %) BSA (mean SD in m2) Procedure characteristics Baseline Mean aortic valve area (mean SD in cm2) Mean trans-aortic gradient (mean SD in mm Hg) Post-balloon aortic valvuloplasty Mean aortic valve area (mean SD in cm2) Mean trans-aortic gradient (mean SD in mm Hg) Introducer sheath size Nine French Ten French Eleven French Twelve French Activated clotting time (mean SD in sec)
83 7.3 65–93 10 (48%) 11 (52%) 18 (86%) 6 (28%) 1.43 0.68 0.59–2.93 11 (52%) 4 (19%) 21 (100%) 57 20 15–85 1.87 0.36 0.60 0.17 45 14 0.81 0.21 30 10 2 17 1 1 215 41
PATIENTS AND METHODS Patient Population From February 2009 to July 2010, 21 patients with high risk, severe, symptomatic aortic stenosis underwent retrograde transfemoral percutaneous BAV at our hospital. Their femoral arteriotomies were closed using one or more 8F Angio-Seal closure devices with a double wire technique. Description of Technique The Angio-Seal hemostatic puncture closure device (St. Jude Medical, St. Paul, MN) is a sheath-delivered vascular closure device that deposits a bioabsorbable small collagen plug adjacent to the arterial wall. The device creates a mechanical seal by sandwiching the arteriotomy between a bioabsorbable anchor and a collagen sponge. Since its first reported use in 1995 [12,13], it has been widely accepted as a safe, easy to use and effective hemostatic alternative technique to manual compression. It is currently available in 6F and 8F models and is intended for use in sealing defects in the femoral arterial wall produced by percutaneous access using 8F or smaller sheaths or catheters. After obtaining informed written consent, a retrograde femoral approach percutaneous BAV was performed using Tyshek-X or Z-Med balloons inflated
during rapid ventricular pacing. Intravenous low dose unfractionated heparin was administered (50 U/kg). At the conclusion of the procedure, femoral angiography was performed through the procedure sheath for assessment of the degree of peripheral vascular disease, the location of the entry site and tortuosity. If the anatomy was suitable for vascular closure we proceeded to close the femoral arteriotomy with an 8F Angio-Seal closure device with the following modifications. The insertion wire provided in the Angio-Seal device kit is inserted through the large bore procedure sheath. However, prior to removal of the procedure sheath, a second additional 0.03500 J-tipped 110 cm wire is also placed through the same sheath. With two wires in place, the procedure sheath is removed and the Angio-Seal insertion sheath is loaded onto the conventional wire provided in the kit. The collagen plug is then deployed using the standard technique with the exception that once the plug has been deployed, the additional 0.03500 J-tipped wire remains across the femoral arteriotomy in the artery (see Fig. 1A). If hemostasis is achieved, the second 0.035’’ J-tipped 110 cm wire is carefully withdrawn so as not to dislodge the collagen plug. As the wire is withdrawn, it is critical to maintain simultaneous traction on the Angio-Seal suture while maintaining pressure on the collagen plug with the tamper tube.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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Once the second wire is removed, we insure that the deployed collagen plug is well seated by reapplying pressure to the tamper tube onto the collagen plug. The procedure is then completed in standard fashion. If adequate hemostasis is not achieved immediately after the initial Angio-Seal is deployed, then a second Angio-Seal insertion sheath is loaded onto the second wire, and deployment of a second adjacent collagen plug is performed in standard fashion. Thus, the second wire allows for deployment of a ‘‘back-up/safety’’ collagen plug in the event that the first collagen plug is inadequate to close the arteriotomy defect (see Fig. 1B). RESULTS
Patient and procedural data are shown in Table I. Patients with aortic stenosis were referred for BAV for the following indications: marked overall debilitation (n ¼ 8), severe left ventricular systolic dysfunction (n ¼ 2), severe chronic lung disease (n ¼ 2), medical therapy arm PARTNER (Placement AoRTic TraNscathetER valve) Trial (n ¼ 5), bridge to percutaneous aortic valve PARTNER Trial (n ¼ 1), metastatic cancer (n ¼ 2), recurrent heart failure and patient not amenable to surgery (n ¼ 1). The mean age of patients was 83 7.3 years, (range 65–93 years) and 52% were women. Diabetes mellitus was present in 28% of patients (6/21). New York Heart Association Class III-IV congestive heart failure was present in 100% of patients. 52% (11/21) had coronary artery disease. The baseline mean aortic valve area was 0.60 0.17 cm2 (range, 0.37–0.90 cm2) with a mean gradient of 45 14 mm Hg (range, 24–87 mm Hg). The mean aortic valve area post procedure was 0.81 0.21 cm2 (range, 0.46–1.1 cm2) with a mean gradient of 30 10 mm Hg (range, 14–53 mm Hg). The mean activated clotting time at the conclusion of the procedure was 215 41 sec. All femoral access sites could successfully be closed using one or more 8F Angio-Seal closure devices. Because the 8F Angio-Seal device is only intended for use in sealing defects in the femoral arterial wall produced by percutaneous access using 8F or smaller sheaths or catheters and its efficacy in closing larger defects has not been reported, we initially attempted closure first in 9F defects and then proceeded to close larger femoral arteriotomy defects. We achieved immediate hemostasis in 21/21 attempted cases. This included 9F (2), 10F (17), 11F (1), and 12F (1) femoral arteriotomies. In 18 cases, hemostasis was achieved employing a single 8F Angio-Seal closure device. In three cases, which all involved 10F femoral arteriotomies, a single collagen plug was inadequate to achieve hemostasis,
and a second ‘‘back-up/safety’’ plug was deployed allowing successful immediate hemostasis. No procedural mortality was observed. No patient suffered a myocardial infarction, stroke, serious arrhythmia, or prolonged hypotension related to the procedure. No significant bleeding was observed immediately post procedure and prior to hospital discharge. We observed no significant local vascular complications requiring surgery or blood transfusion following device closure. DISCUSSION
Historically, percutaneous BAV has been associated with a high rate of local vascular complications due to the requirement of large bore femoral artery access. In the Mansfield Scientific Aortic Valvuloplasty Registry, 492 patients with aortic stenosis underwent percutaneous BAV from 1986 to 1987 [11]. The overall complication rate for the procedure was 20.5% with vascular injury occurring in 11% of patients. Vascular surgery was required in 6% of patients. In the NHLBI Balloon Valvuloplasty Registry, 674 patients with aortic stenosis underwent percutaneous BAV from 1987 to 1989 [10]. The complication rate during or within 24 hr after valvuloplasty procedure was 25%, with vascular complications being the most common. In this cohort, 23% of patients required transfusion prior to discharge and 7% of patients required vascular surgery. Although, the mortality of this procedure is low, the bleeding complications that occur post procedure add significant morbidity. Therefore, methods aimed at decreasing vascular complication rates post procedure are warranted. Technologic innovations since these early registries include smaller balloon sizes that have allowed usage of smaller femoral arterial access sheaths and the development of arterial closure devices. Despite these advances, the vascular complication rate has remained high (16%) in contemporary experience [14]. Arterial closure devices have gained widespread use as adjunctive treatment in patients undergoing coronary angiography and angioplasty. These devices offer several advantages over manual compression, including a decreased time to hemostasis, decreased time to ambulation and improved overall patient comfort [15]. In large meta-analyses they are noninferior to manual compression in terms of reducing vascular complications [16]. Their role in potentially reducing vascular complications in procedures that require large bore arterial access such as BAV has not been well studied. This report describes our initial experience using a modified ‘‘double wire’’ Angio-Seal closure device
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
‘‘Double Wire’’ Angio-Seal Closure Technique
technique to manage femoral artery access following percutaneous BAV. Our use of an 8F Angio-Seal closure device to successfully close larger 9-12F defects is novel and has not been reported to our knowledge. In 21/21 patients we successfully achieved immediate hemostasis following percutaneous BAV with no immediate bleeding complications. When we were not able to achieve adequate hemostasis following deployment of a single 8F Angio-Seal collagen plug, our technique of employing a second delivery wire as described allowed deployment of a ‘‘back-up/safety’’ second collagen plug with achievement of hemostasis. Although the frequency of needing a second device was low (14%), the availability of this option likely reduced vascular problems and improves operator confidence in obtaining hemostasis. Suture based closure devices have been employed to close arterial puncture defects of 6-24F in diameter [17,18]. Although they are effective, they require more complex catheter manipulations to perform. Complications related to suture-mediated devices include arterial injury, arterial thrombosis, claudication, and arterial distortion [19–21]. Arterial constriction after suture-mediated closure device placement [22] may pose a particular challenge for patients requiring repeat access for BAV due to recurrent aortic stenosis or for later transcatheter aortic valve implantation. For these reasons, we believe a vascular closure device such as the Angio-Seal that is both simple to deploy and is based on a bioabsorbable platform may be preferable. The present series was limited by its small size; however, we observed that we were able to achieve hemostasis using this technique in all of the attempted vascular closures. The use of an 8F Angio-Seal closure device with a second delivery wire for back-up deployment of a second collagen plug if required, offers a simple technique to achieve vascular closure following large bore femoral artery access following percutaneous BAV. Further studies are warranted to determine whether this approach can result in decreased vascular complications and be used with even larger devices.
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Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).