Direct Flow Implantation in a Patient With Mechanical Mitral Prostheses

Ann Thorac Surg 2016;101:753–6

CASE REPORT BRUSCHI ET AL DIRECT FLOW IN PRESENCE OF MITRAL PROSTHESIS

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Fig 1. Hemopatch (Baxter Deutschland GmbH, Unterschleissheim, Germany) application before cardiopulmonary bypass. (A) Diffuse bleeding caused by ventricular wall laceration. (B) Encouraging hemostatic result after Hemopatch application.

2. Lewis KM, Spazierer D, Slezak P, Baumgartner B, Regenbogen J, Gulle H. Swelling, sealing, and hemostatic ability of a novel biomaterial: a polyethylene glycol–coated collagen pad. J Biomater Appl 2014;29:780–8. 3. Besser MW, Ortmann E, Klein AA. Haemostatic management of cardiac surgical haemorrhage. Anaesthesia 2015;70 (Suppl 1):87–95, e29–31.

Direct Flow Implantation in a Patient With Mechanical Mitral Prostheses

Cardiology and Cardiac Surgery Department, Niguarda Ca’ Granda Hospital, Milan, Italy Fig 2. Favorable hemostatic and sealing effect of Hemopatch (Baxter Deutschland GmbH, Unterschleissheim, Germany), which was applied after successful separation from cardiopulmonary bypass and transfusion of platelets and plasma products.

superficially eroded pulmonary parenchyma in several redo cases to seal pulmonary leaks, with a favorable primary result. On the basis of our limited experience, we conclude that Hemopatch provides sufficient hemostasis and wound sealing in cardiac surgical procedures. Quick hemostasis, rapid and tight attachment to the underlying tissue, and the absence of human-derived (potentially infectious) clotting factors make Hemopatch an attractive material for securing hemostasis during cardiac surgical procedures.

We describe a case of Direct Flow (Direct Flow Medical Inc, Santa Rosa, CA) transcatheter aortic valve implantation in a patient with a mechanical valve in a mitral position. (Ann Thorac Surg 2016;101:753–6) Ó 2016 by The Society of Thoracic Surgeons

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ranscatheter aortic valves have been designed to treat elderly patients with severe aortic stenosis who are considered high-risk surgical candidates. The safety and effectiveness of transcatheter aortic valve implantation Accepted for publication Feb 18, 2015. Address correspondence to Dr Bruschi, Cardiology and Cardiac Surgery Department, Niguarda Ca’ Granda Hospital, Piazza dell’Ospedale Maggiore 3, 20162, Milan, Italy; email: [email protected].

References 1. Lewis KM, Schiviz A, Hedrich HC, Regenbogen J, Goppelt A. Hemostatic efficacy of a novel, PEG-coated collagen pad in clinically relevant animal models. Int J Surg 2014;12:940–4. Ó 2016 by The Society of Thoracic Surgeons Published by Elsevier

Dr Bruschi discloses a financial relationship with Direct Flow and Medtronic; and Dr de Marco with Direct Flow.

0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2015.02.139

FEATURE ARTICLES

Giuseppe Bruschi, MD, Alberto Barosi, MD, Paola Colombo, MD, PhD, Emanuela Montorsi, MD, Stefano Nava, MD, Francesco Soriano, MD, Luca Botta, MD, PhD, Pasquale Fratto, MD, Silvio Klugmann, MD, and Federico de Marco, MD, PhD

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FEATURE ARTICLES

(TAVI) have been demonstrated in numerous observational clinical studies, national registries [1], and controlled randomized trials [2, 3]. Nevertheless, patients who have undergone previous mitral valve operations have often been excluded from this operation because of concerns for possible interference between the TAV and the mitral prosthesis. We describe a case of Direct Flow (Direct Flow Medical Inc, Santa Rosa, CA) transcatheter aortic valve implantation (TAVI) in a patient with a mechanical valve in a mitral position. The Direct Flow Medical TAVI is the first TAV device that is not based on a metallic frame technology. The bovine pericardial prosthesis has an inflatable and deflatable support structure that allows precise positioning, retrieval, and assessment of valve performance before final fixation with a durable polymer. An 18F sheath is used for all valve sizes [4]. A 74-year-old woman (weight, 45 kg; height, 155 cm) affected by severe aortic stenosis was admitted to our hospital from the emergency department for dyspnea at rest. In 1990, the patient underwent mitral valve replacement with a 29-mm Carbomedics bileaflet mechanical valve (Sorin Biomedical Cardio, Saluggia VC, Italy). In 2010, she underwent thyroidectomy for cancer. The patient was affected by moderate to severe renal failure with a creatinine clearance of 37 mL/min and chronic atrial fibrillation. After clinical stabilization, the patient underwent echocardiographic evaluation that found severe aortic stenosis with a mean gradient of 54 mm Hg, an aortic valve area of 0.61 cm2/m2 with severely depressed left ventricular function, and an ejection fraction of 22%. Normal coronary arteries were evident on coronary angiography. Echocardiographically gated computed tomography was performed and showed a trileaflet calcified aortic valve with an annulus perimeter of 75 mm (27 20 mm). The distance between the aortic annulus and the mechanical mitral titanium stiffening ring was between 7.4


and 8.9 mm (Fig 1). After evaluation by the heart team taking into consideration her previous cardiac operation, severe left ventricular dysfunction, and comorbidities (EuroSCORE II, 25.6%; STS mortality score, 18.4%), TAVI was preferred. Because of its retrievability and capacity for repositioning, placement of a Direct Flow device was planned. The procedure was performed with the patient under local anesthesia and mild sedation in a hybrid operating room by a team composed of an interventional cardiologist, “hybrid” cardiac surgeon, and cardiac anesthesiologist. A temporary pacing lead was advanced in the right ventricle through the right jugular vein. Percutaneous femoral access was performed with the placement of 2 Perclose ProGlide Suture-Mediated Closure Systems (Abbott Laboratories, Abbott Park, Illinois). A pigtail catheter was placed in the noncoronary cusp through the left femoral access to mark the position of the lowest point of this cusp. Pre-TAVI balloon aortic valvuloplasty was performed under rapid pacing using a Bard “True” 22-mm (Loma Vista Medical, Burlingame, CA). A 25-mm Direct Flow bioprosthesis was advanced through the aortic valve in the left ventricle. After unsheathing, the valve rings were inflated in the left ventricular outflow tract with a contrast-saline mixture through the positioning wires of the delivery system. The bioprosthesis was then positioned using the 3 independent positioning wires with the standard implantation technique for the Direct Flow device, ie, the inner curve technique [5]. No interference between the mitral valve and the Direct Flow prosthesis was evident during implantation. Fluoroscopic optimal positioning of the Direct Flow valve was confirmed by the symmetric and circular inflation of the aortic ring above the calcified native leaflets, with no interference with the mitral prosthesis and normal leaflet motion. Angiography confirmed correct Direct Flow placement, with a trivial paravalvular leak and normal coronary flow. An evaluation of the normal fluoroscopic movement of the mechanical mitral prosthesis was carried out (Fig 2).

Fig 1. Preoperative computed tomographic evaluation of distance from mitral mechanical valve housing and native aortic annulus.



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Fig 2. (A) Evaluation of normal fluoroscopic movement of mechanical mitral prosthesis during implantation. (B) Final valve assessment with normal mitral prosthesis motion, good Direct Flow positioning, and normal coronary flow.

Comment Concerns exist about possible interference between the mitral prosthetic housing and transcatheter valve, which might interfere with optimal valve deployment, increasing the risk of prosthesis shift and misplacement. Few single-center experiences have been published in the literature on TAVI in patients with biological or mechanical mitral valve prostheses using either the Edwards SAPIEN (Edwards Lifesciences, Irvine, CA) or the CoreValve (Medtronic, Inc, Minneapolis, MN) TAVI device [6–8]. As reported by other authors, the presence of a mechanical valve in the mitral position might complicate TAVI because of the reduction of the mitral-aortic space to accommodate the transcatheter valve and because the presence of a mechanical valve can limit the expansion of the transcatheter prosthesis. In our experience, we have successfully treated 15 patients with a CoreValve TAVI after mitral valve operations, with no interference between the CoreValve device and the mitral prosthesis. We suggest that it is probable that direct aortic access with a short distance between the entry site and the aortic annulus and higher valve deployment control should be better in these patients. The advantage of a fully repositionable and resheathable valve should be of particular interest in this patient population. We believe that repositionable TAVI technologies could be of particular advantage in this specific patient subgroup with mechanical mitral prostheses. In case any interaction between the 2

prostheses should occur with mitral leaflet impingement after TAVI device implantation, the latter could be repositioned to restore proper mitral function. In our patient, there was no need for valve retrieval. Direct Flow valve retrieval occurs in a low percentage of cases (< 10%) with implantation through the use of the inner curve technique. Echocardiographic assessment and multislice computed tomographic reconstruction are crucial to determine both the distance between the aortic annulus and the housing of the mitral prosthesis and the extent of prosthetic strut protrusion into the left ventricular outflow tract. Our experience demonstrated the safety and feasibility of Direct Flow implantation in patients with mechanical mitral prostheses.

References 1. Abdel-Wahab M, Zahn R, Gerckens U, et al, German TAVI Registry Investigators. Predictors of 1-year mortality in patients with aortic regurgitation after transcatheter aortic valve implantation: an analysis from the multicentre German TAVI registry. Heart 2014;15(100):1250–6. 2. Smith CR, Leon MB, Mack MJ, et al, PARTNER Trial Investigators. Transcatheter versus surgical aortic valve replacement in high-risk patients. N Engl J Med 2011;364: 2187–98. 3. Adams DH, Popma JJ, Reardon MJ, et al, U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014;370:1790–8. 4. Schofer J, Colombo A, Klugmann S, et al. Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve. J Am Coll Cardiol 2014;63:763–8. 5. De Marco F, Latib A. Tools and Techniques – Clinical: The inner curve technique for implantation of the Direct Flow MedicalÒ transcatheter aortic valve. EuroIntervention 2014;10: 400–2. 6. Soon JL, Ye J, Lichtenstein SV, Wood D, Webb JG, Cheung A. Transapical transcatheter aortic valve implantation in the presence of a mitral prosthesis. J Am Coll Cardiol 2011;58: 715–21. 7. Bruschi G, De Marco F, Barosi A, et al. Self-expandable transcatheter aortic valve implantation for aortic stenosis after mitral valve surgery. Interact Cardiovasc Thorac Surg 2013;17:90–5.

FEATURE ARTICLES

In case any interaction between the Direct Flow device and the mitral prosthesis was detected, the TAVI device could have been deflated and repositioned. After echocardiographic and hemodynamics evaluation, which showed an invasive transvalvular mean gradient of 10 mm Hg and a trivial paravalvular leak on transthoracic echocardiographic imaging, the contrastsaline mixture was exchanged for the polymer to fix the valve in position. The positioning wires were then detached and the delivery system removed.

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CASE REPORT MANDAL ET AL ROBOT-ASSISTED ATRIOVENTRICULAR REPAIR


8. Barbanti M, Ussia GP, Latib A, et al. Transcatheter aortic valve implantation in patients with mitral prosthesis. J Am Coll Cardiol 2012;60:1841–2.

Robot-Assisted Partial Atrioventricular Canal Defect Repair and Cryo-Maze Procedure Kaushik Mandal, MD, Aseem R. Srivastava, MD, L. Wiley Nifong, MD, and W. Randolph Chitwood, Jr, MD

FEATURE ARTICLES

Division of Cardiac Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland; and Department of Cardiovascular Surgery, East Carolina Heart Institute at East Carolina University, Greenville, North Carolina

Atrial septal defect is one of the most common congenital heart anomalies in adults. Patients with partial atrioventricular canal defects, previously known as ostium primum atrial septal defect, usually present at an early age, and only a few reach adulthood without surgical correction. Herein, we describe a young woman who presented with an ostium primum defect and severe symptomatic mitral and tricuspid regurgitation with paroxysmal atrial fibrillation. A complex repair was successfully done through a left atrial approach using robot-assistance. (Ann Thorac Surg 2016;101:756–8) Ó 2016 by The Society of Thoracic Surgeons

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trial septal defect (ASD) is one of the most common congenital heart anomalies in adults. However, patients with partial atrioventricular canal defects, previously known as ostium primum ASD, usually present at an early age, and only few of them reach adulthood without a surgical correction [1]. A 43-year-old woman was referred for evaluation of progressively worsening shortness of breath. She had a history of a loud heart murmur and also paroxysmal atrial fibrillation. She never had congestive heart failure, stroke/transient ischemic attack, or chest pain. Physical examination revealed an irregular pulse at 88 beats/min, blood pressure of 110/70 mm Hg, and an III/IV (grade 3) pansystolic murmur heard at the left sternal border. There were no signs of congestive heart failure. Her chest roentgenogram demonstrated increased pulmonary vascularity, enlarged central pulmonary arteries, and cardiomegaly, all of which were consistent with left-to-right cardiac shunting. Her pulmonary function tests revealed a mild obstructive defect with bronchodilator reversibility. Her electrocardiogram revealed right ventricular hypertrophy Accepted for publication Feb 12, 2015. Presented at the Video Session of the Fifty-first Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 24–28, 2015. Address correspondence to Dr Mandal, Division of Cardiac Surgery, Sheikh Zayed Tower, Ste 7107, Johns Hopkins Hospital, 1800 Orleans St, Baltimore, MD 21287; email: [email protected].

Ó 2016 by The Society of Thoracic Surgeons Published by Elsevier

Fig 1. (A) Preoperative transesophageal echocardiogram shows dilated right and left atria, a 2.7-cm defect at the lower interatrial septum (blue arrow pointing at the ostium primum defect), and severe left atrioventricular valve insufficiency. (B) Intraoperative view of the partial atrioventricular canal defect, as seen from left atriotomy, shows the vent suction going across the atrial septal defect (blue arrow) and down the right atrioventricular valve into the right ventricle. The junction between the right and left atrioventricular valves and underlying interventricular crest is highlighted by the green arrow. The black arrow shows the cleft in the anterior leaflet of left atrioventricular valve. The inset shows an artist’s rendition of the anatomy of the partial atrioventricular canal defect.

and atrial fibrillation at approximately 82 beats/min. A transesophageal echocardiogram showed dilated right and left atria and a 2.7-cm defect along the lower interatrial septum (Fig 1A), severe left atrioventricular valve (LAVV) insufficiency, and a complete mitral valve anterior leaflet cleft. The right atrioventricular valve (RAVV) also had moderate insufficiency, with a defect extending along the septal leaflet. The flow across the large defect remained from left to right with a Qp:Qs of 2:1. There was no ventricular septal defect. Despite right ventricular dilatation, her biventricular global function was 55%.

Robot-Assisted Repair The DaVinci Si dual-console robot (Intuitive Surgical Inc, Sunnyvale, CA) system was used for the surgical repair. Our robotic left atrial approach case setup has been detailed in previous publication [2]. An autologous pericardial patch was harvested upon opening the pericardium and fixed with 0.5% glutaraldehyde. After institution of cardiopulmonary bypass, aortic crossclamping, and cardioplegic arrest, the anatomy of the atrioventricular canal defect (Fig 1B) was evaluated through a left atriotomy. In particular, LAVV and RAVV 0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2015.02.135