A Novel Method for Closing the Percutaneous Transapical Access Tract Using Coils and Gelatin Matrix

   ABSTRACT: A patient with a symptomatic mitral paravalvular leak was successfully treated by implantation of an Amplatzer (16 mm) occluder device (AGA Medical, Plymouth, Minnesota) at the defect via percutaneous direct transapical puncture of the left ventricle. We describe a novel technique for closure and immediate hemostasis of the transapical access tract, comprising two stainless steel coils deployed across the myocardial wound and a hemostatic matrix injected at the epicardium and within the subcutaneous tract. J INVASIVE CARDIOL 2010;22:E107–E109    Key words: direct left ventricular access, mitral paravalvular leak, ventricular access closure    Percutaneous direct left ventricular (LV) access has been used since the 1950s for hemodynamic evaluation.¹ With the subsequent introduction of the Seldinger technique and the development of specific catheters,² peripheral vascular access became the most common approach for percutaneous cardiac procedures. Nevertheless, there are multiple clinical circumstances where direct left ventricular access is required for diagnostic or interventional indications including access to the LV in the setting of double mechanical valves, inaccessible percutaneous paravalvular leak repair,³ complex congenital heart disease,⁴ carotid interventions,⁵ percutaneous valve implantation⁶ and many others.    One of the major concerns when performing trans-catheter procedures via a transapical approach is how to prevent bleeding complications and obtain hemostasis without converting the procedure into a more invasive surgical incision. Manual compression and purse-string sutures⁶ have been performed after LV access but these are not considered attractive closure techniques during percutaneous procedures.    We describe a novel method for ventricular access closure, using a combination of stainless steel coils through the myocardial wound followed by an injectable hemostatic gelatin matrix at the epicardium and subcutaneous skin tract.    Case Report. A 53-year-old female presented with symptomatic biventricular heart failure and hemolysis secondary to a mitral paravalvular leak (M-PVL). She had a history of two previous bioprosthetic mitral valve replacements (most recently 2003) and a M-PVL repaired percutaneously 1 year prior using an Amplatzer (16 mm) muscular VSD occluder device.    A transesophageal echocardiogram (TEE) and computed tomography angiography (CTA) with 3/4D volume rendered reconstruction were performed demonstrating a de novo M-PVL at the interface between the valve ring and the previous Amplatzer occluder device. Initially, a conventional antegrade, transfemoral vein approach to the mitral valve was attempted. Using aseptic technique, an 8 Fr Mullins sheath was advanced from the right femoral vein into the interatrial septum, supported by a Broken-brough needle. Several attempts to puncture the interatrial septum were unsuccessful due to severely dilated right atrium and septal fibrosis from previous interventions. Therefore a direct left ventricle transapical approach was used.    Under fluoroscopic guidance, the left ventricle was approached percutaneously in between the papillary muscles, using a 21 gauge micropuncture kit (Cook, Inc., Bloomington, Indiana). A 6 Fr radial artery sheath was inserted directly into the LV chamber. A left ventricular angiogram was performed with hand injection through the LV sheath, demonstrating the eccentric regurgitant jet from the M-PVL into the left atrium (LA). A 65 cm 5 Fr Berenstein catheter was advanced into the LV over a straight-tip 0.035-inch glidewire. To facilitate crossing of the paravalvular defect, CTA (4-D) data were co-registered with fluoroscopic images in the catheterization suite. The M-PVL was crossed retrogradely with the glidewire, and the Berenstein catheter was advanced into the left atrium (LA). The glidewire was then exchanged for a 0.035-inch Amplatz stiff wire and an 8 Fr delivery system was advanced transapically into the LA over the stiff wire. A 16 mm Amplatzer muscular VSD occluder device was delivered at the M-PVL. Once TEE confirmed the stability of the device without interference with the mitral bioprosthesis function, the device was released.    The delivery sheath was then exchanged for an 8 Fr 25 cm sheath at the LV access. Two 4 Fr sheaths were each loaded with 52-10-15 stainless steel coils (Cook) and both sheaths were inserted side-by-side into the 8 Fr sheath to deploy both coils in the LV apical tract (Figure 1). This was performed with the aid of biopsy forceps and under fluoroscopic and TEE guidance to ensure each coil fully traversed the myocardial tract. Subsequently, “Surgi-flo”, a commercial hemostatic matrix (Johnson & Johnson/Cordis Corp., Somerville, New Jersey) was mixed with 2 cc of saline to a paste-like consistency. Approximately 4 ml of this mixture was injected through the sheath, into the pericardial and subcutaneous tract to prevent any subcutaneous bleeding (Figure 1).    The patient was recovered hemodynamically and was discharged 48 hours post procedure without major complications. Follow-up imaging, including a transthoracic echo and CTA (3D/4D) scan, confirmed stability of the Amplatzer device and complete closure of the M-PVL, with preserved mitral valve function and a mild hemothorax. Outpatient follow up demonstrated clinical improvement with no late procedure complications.    Discussion. We describe a novel technique for closing a large-caliber, transapical LV access tract, in a patient undergoing percutaneous M-PVL repair. We used a combination of stainless steel coils and local application of gelatin matrix in the subcutaneous track to obtain immediate hemostasis after the procedure.    Paravalvular leak repair constitutes one of the unique challenges for the interventional cardiologist. The conventional antegrade, transfemoral vein approach using a 7–9 Fr delivery sheath requires puncture of the interatrial septum. This was not feasible in the present case due to excessive septal fibrosis from previous interventions. Therefore, we elected to use the direct percutaneous transapical LV approach. This facilitated coaxial alignment of the delivery sheath relative to the paravalvular defect.    Successful access to the LV via the direct transapical approach is universally high, and the rate of procedure-related major complications is low (1.5–3%).^1,7 Hemopericardium and chest wall hematoma are well-documented complications of direct transapical access especially after sheath manipulation.⁷    Current options for apical closure include manual pressure at the puncture site, purse-string sutures and deployment of an Amplatzer occlusive device across the ventriculostomy in a few cases.⁴    Stainless steel coils, sometimes used in combination with an injectable hemostatic matrix, are widely utilized to promote thrombosis in a range of vascular interventional settings.In the present case, we anticipated that coil deployment would not, of itself, yield immediate and satisfactory hemostasis at this high-pressure site. Therefore, a small plug of the porcine-derived gelatin matrix ‘Surgiflo’ was successfully applied to the surface of the epicardial access tract, extending into the subcutaneous tissue. Gelatin matrixes are best utilized as hemostatic devices, and not as a tissue glue or sealant,^8,9 hence the need for coils within the tract to promote thrombosis and healing.    Gelatin-based hemostats act through physical surface effects and by interacting with the blood-clotting cascade.⁸ Surgiflo is designed to be injected directly to the bleeding site after premixing with either saline, or thrombin if more rapid hemostasis is desirable.⁹ The constituent gelatin granules swell up to 20% within 10 minutes when contacted by blood, and hemostasis is achieved predominantly through wound tamponade. The matrix is then metabolized by proteases and absorbed within 4–6 weeks with negligible tissue reaction. We injected the agent under fluoroscopic guidance, and without the addition of thrombin, to further minimize any risk of systemic thromboembolism.    Alternative classes of bioactive hemostatic agents include: fibrin sealants, collagen derivatives, hydrogels, glutaraldehyde- based adhesives, and newer inorganic and polymeric hemostats. Selection of the most appropriate hemostatic agent depends on the clinical setting and patient safety concerns. Comparative trials of the various agents are relatively few. Gelatin-based agents reportedly generate a more efficacious clot than collagen-based counterparts,⁹ especially at sites of heavy bleeding and in heparinized patients.¹⁰ However, there is debate regarding the long-term propensity toward adhesions with gelatin hemostats, especially when augmented with thrombin. Further studies will help determine which topical hemostatic agent best complements coil-assisted hemostasis at the transapical LV access tract for interventions using large-caliber sheaths.    Conclusion. We describe a novel method for closure of the direct transapical LV access using transmyocardial coils combined with gelatin matrix injected at the epicardium and subcutaneous tract. We believe further study and refinement of this technique may yield an alternate strategy for achieving safe and rapid hemostasis following percutaneous, direct LV access.

References

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_________________________________________________ From the Department of Interventional and Structural Heart Disease, Lenox Hill Heart and Vascular Institute of New York, New York. Disclosure: Dr. Carlos E. Ruiz is proctor for AGA. The other authors report no conflicts of interest regarding the content herein. Manuscript submitted October 27, 2009 and accepted November 19, 2009. Address for correspondence: Carlos E. Ruiz, MD, PhD, Lenox Hill Heart and Vascular Institute, 130 East 77th Street. 9th Floor Black Hall, New York, NY 10075. E-mail: cruiz@lenoxhill.net