Case Presentation:
The patient is a 60 year old male with hypertrophic cardiomyopathy. He has developed progressive heart failure symptoms over the past 10 years with recent multiple readmissions for decompensated heart failure. He was started on chronic IV milrinone and was listed for heart transplantation. His PMH is notable for atrial arrhythmias s/p ablation, recurrent pulmonary embolism, pulmonary hypertension, left atrial thrombus, and prior stroke. Cardiopulmonary exercise testing demonstrated a low maximal oxygen consumption ( VO2 max 10.6 ml/kg min). Imaging was notable for severe LV hypertrophy with moderate to severely reduced systolic function, and no LV outflow tract obstruction (LVEF 25-30%, LVIDd 5.0 cm, IVSd 1.5 cm, LVPWd 1.5 cm). He had a large left atrial thrombus in the appendage and a possible LV thrombus as well. Hemodynamics (on milrinone 0.5 mcg/kg/min) were notable for: RA 17 mmHg, PCWP 37 mmHg, PA 74/35 mmHg, and Fick CI 1.4 L/min/m2. Due to his restrictive myopathy and small LV cavity, he was considered to be a poor candidate for isolated left ventricular assist device.
1. The Device
<ol>
	<li>The Syncardia total artificial heart is the only FDA approved TAH in clinical use. It was first introduced in 1982 as the Jarvik-7 heart.</li>
	<li>The device consists of 2 polyurethane ventricle chambers. Each chamber has a maximum stroke volume of ~ 70 ml. Each chamber has 2 tilting disc valves (Medtronic Hall, 27 mm inflow, 25 mm outflow) to direct blood inflow and outflow. Each chamber is pneumatically driven by a separate driveline connected to a driver externally (Figure 1).</li>
</ol>
2. Indications
<ol>
	<li>The device displaces a total volume of ~400 ml. General minimum recipient size recommendation include a BSA &#62; 1.7 m2 and a thoracic diameter (AP dimension spine to sternum at the level of the 10th thoracic vertebra) &#62; 10 cm (Figure 2). Placement in smaller patients is possible by displacing the device into the left chest although this increases the risk for left sided pulmonary vein and bronchus compression. A smaller sized device for use in smaller patients is being developed and is expected in the near future.</li>
	<li>TAH support is indicated in patients with late stage severe biventricular failure or other anatomic abnormality that is not optimally treated with isolated left ventricular mechanical support. Such patients often present in extremis with complications related to their malperfusion. Typically patients are classified as INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile 1 (critical cardiogenic shock) or 2 (progressive decline on inotropic support).</li>
	<li>Patients with significant concomitant cardiac pathology. Critically ill patients with end stage heart failure requiring mechanical support may not be optimally treated by the addition of other extensive reparative procedures. This may increase the risk for right ventricular failure post LVAD implantation, which increases the risk for perioperative morbidity and mortality. This includes: acute myocardial infarction with ventricular septal defect; aortic root aneurysm / dissection, cardiac allograft failure, massive ventricular thrombus, refractory malignant arrhythmias (independent of filling pressures), hypertrophic / restrictive cardiomyopathy, and complex congenital heart disease.</li>
</ol>
3. Preparation of the Device
<ol>
	<li>The Dacron aortic and pulmonary grafts are sealed with CoSeal Surgical Sealant (Figure 3).</li>
	<li>The grafts and devices are soaked in rifampin.</li>
</ol>
4. Implantation
<ol>
	<li>Routine preparation and median sternotomy. The chest and abdomen are prepped in the routine fashion for cardiac surgery and a median sternotomy is performed.</li>
	<li>Division of the left diaphragm and creation of a left upper abdominal preperitoneal pocket. Similar to the implant of an LVAD, the left diaphragm is divided medially and a left upper abdominal preperitoneal pocket is created for the pneumatic drivelines. Two incisions ~5-10 cm below the left costal margin are made and carried through the rectus fascia. Intramuscular tunnels for the pneumatic drivelines are created and maintained with two 1&#34; Penrose drains.</li>
	<li>Cannulation and initiation of cardiopulmonary bypass. The aorta, SVC, and IVC are cannulated. Bicaval cannulation is performed through the atria (vs direct cannulation of the SVC/IVC) to preserve the sites for use during subsequent transplantation. Unnecessary dissection within the pericardium is minimized to preserve tissue planes.</li>
	<li>The aorta is cross clamped. The aortic root and pulmonary artery are divided at the level of the valvar commissures. Excision of the right ventricle is started along the acute margin, 1-2 cm distal to and parallel to the right atrioventricular groove. The interventricular septum is incised opening the left ventricle. The right ventricular incision is continued superiorly into the RV outflow tract. Similarly, the left ventricle incision is extended laterally parallel to the left atrioventricular groove. The LV outflow tract is opened laterally. The remaining interventricular septum is divided and specimen is removed (Figure 4).</li>
	<li>The coronary sinus is oversewn. If a PFO is identified it is similarly oversewn. The left atrial appendage is ligated with a non cutting endoscopic stapler to eliminate a potential source of thrombus (Figures 5 and 6).</li>
	<li>The mitral and tricuspid valve leaflets are excised leaving a several millimeter cuff to the annulus. The ventricular cuffs are trimmed leaving a 1 cm rim of tissue. The cuffs are then oversewn with 2-0 Prolene (MH) for hemostasis and to downsize the orifice to the size of the TAH atrial quick connects. Some centers elect to use a reinforcing strip of felt.</li>
	<li>The cuffs of the TAH atrial quick connects are trimmed to 0.5-1 cm. The cuffs are then inverted and sewn to their respective left and right ventricular cuffs.</li>
	<li>In a similar fashion, the aortic and pulmonary artery graft quick connects are trimmed. The pulmonic graft is left several centimeters longer than the aortic graft to allow room for the aortic graft to pass below. The grafts are sewn to their respective orifices (Figure 7).</li>
	<li>At the time of subsequent re-entry for transplantation, an intense inflammatory response of the pericardium is often seen. Dissection through this tissue at the time of transplantation can be associated with significant blood loss. This appears to be greater than what is typically seen during redo sternotomy. Preclude pericardial membrane is used to line the pericardium and maintain avascular tissue planes. This is started along the left inferolateral pericardium as access to this space will be hindered once the device is in place. Strips of Preclude are also placed around the aortic and pulmonic anastomoses. Some centers use sterilized rubber tourniquets to wrap the anastomoses.</li>
	<li>The drivelines are passed through the previously created tunnels. A 13-15 mm Hegar dilator is used to guide the driveline through the previously placed Penrose drain. A sheet of Preclude membrane is wrapped around the drivelines as well. The original metal connectors of the external console driveline are replaced with plastic connectors that will also connect with the portable discharge driver.</li>
	<li>De-airing nipples on the TAH left and right ventricles are ligated. The left and then right artificial ventricles are flushed and then connected to their respective orifices. The pliable quick connects are grasped with 2 heavy needle drivers and stretched over the hard plastic connectors of the artificial ventricles ensuring a tight connection (Figure 8).</li>
	<li>An aortic root vent is placed. Low rate, low pressure pumping is initiated (Left drive pressure 40, right drive pressure 0, % systole 40, rate 40, vacuum 0) and the lungs are ventilated for de-airing. Flow through the right side is initially passive.</li>
	<li>The cross clamp is removed. Once adequate de-airing is confirmed by TEE, cardiopulmonary bypass can be discontinued relatively quickly. TAH support is increased. Typical initial immediate TAH parameters are: Left drive pressure 180-200 mmHg, right drive pressure 30-60 mmHg, HR 100-120 bpm, and % systole 50. Vacuum is generally left at 0 until the chest is closed (or sealed) to prevent entrainment of air. Once sealed, increases in vacuum (generally to 15 mmHg) will result in increased fill volume and increased cardiac output. Parameters are then titrated for partial ventricular filling and complete ejection.</li>
	<li>Protamine is given and the CPB cannulas are removed. Patients requiring a TAH often present with significant end organ dysfunction including chronic hepatic congestion and may have significant associated underlying coagulopathy. The most common complication following TAH implantation is bleeding. We recommend a low threshold for mediastinal packing and delayed sternal closure.</li>
	<li>Once the chest is ready to be closed, the remainder of the pericardium along the right and superiorly is lined with Preclude. The configuration of the TAH does not maintain the normal oblong shape. Contraction of the pericardium about the device will limit the space available for subsequent transplantation. A saline breast implant is used to maintain the apical pericardial space for subsequent transplant. A smooth saline breast implant is placed at the apex and filled with 200-250 ml of saline (Figure 9).</li>
	<li>The chest is closed in the routine fashion. Although imgagin by intraoperative TEE is limited, it remains a useful tool at the end of surgery to assess for compression of the right and left atrial venous return by the device during closure. This is more common on the right (both the cava and right sided pulmonary veins) and can generally be treated with displacement of the device inferiorly and to the left. This can be secured with a heavy suture placed around the costal margin and tied to the artificial right ventricle. A strip of silastic is left beneath the sternum to protect the pump during re-entry for transplantation.</li>
</ol>

<ol><li>Cooley, D. A., Liotta, D., Hallman, G. L., Bloodwell, R. D., Leachman, R. D., Milam, J. D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Orthotopic+cardiac+prosthesis+for+two-staged+cardiac+replacement%5BTitle%5D)+AND+%22American+Journal+of+Cardiology%22%5BJournal%5D)">Orthotopic cardiac prosthesis for two-staged cardiac replacement.</a> American Journal of Cardiology. 24 (5), 723-730 (1969).</li>
<li>Cooley, D. A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((The+total+artificial+heart%5BTitle%5D)+AND+%22Nat.+Med%22%5BJournal%5D)">The total artificial heart.</a> Nat. Med. 9 (1), 108-111 (2003).</li>
<li>DeVries, W. C., Anderson, J. L., Joyce, L. D., Anderson, F. L., Hammond, E. H., Jarvik, R. K., Kolff, W. J. Clinical use of the total artificial. 310 (5), 273-278 (1984).</li>
<li><a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Syncardia+Systems.+1000th+Implant+of+the+World%27s+Only+Approved+Total+Artificial+Heart+Performed.+%5BPress+release%5D%5BTitle%5D)+AND+%22%22%5BJournal%5D)">Syncardia Systems. 1000th Implant of the World's Only Approved Total Artificial Heart Performed. [Press release].</a> , Retrieved from 
 
 <a target="_blank" href="www.syncardia.com">www.syncardia.com</a> (2012).</li>
<li>Joyce, L. D., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Nine+year+experience+with+the+clinical+use+of+total+artificial+hearts+as+cardiac+support+devices%5BTitle%5D)+AND+%22ASAIO+Transactions%22%5BJournal%5D)">Nine year experience with the clinical use of total artificial hearts as cardiac support devices.</a> ASAIO Transactions. 34, 703-707 (1988).</li>
<li>DeVries, W. C. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Surgical+Technique+for+Implantation+of+the+Jarvik-7-100%5BTitle%5D)+AND+%22Total+Artificial+Heart.+JAMA%22%5BJournal%5D)">Surgical Technique for Implantation of the Jarvik-7-100.</a> Total Artificial Heart. JAMA. 259 (6), 875-880 (1988).</li>
<li>Copeland, J. G., et al. Cardiac replacement with a total artificial heart as a bridge to transplantation. <a target="_blank" href="http://scholar.google.com/scholar?hl=en&safe=off&q=author%3aCopeland%2C+JG+%22N.+Engl.+J.+Med%22">N. Engl. J. Med</a>. 351, 859-867 (2004).</li>
<li>Kasirajan, V., Tang, D. G., Katlaps, G. J., Shah, K. B. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((The+total+artificial+heart+for+biventricular+failure+and+beyond%5BTitle%5D)+AND+%22Curr+Opin+Cardiol%22%5BJournal%5D)">The total artificial heart for biventricular failure and beyond.</a> Curr Opin Cardiol. 27, (2012).</li>
<li>Copeland, J. G., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Risk+factor+analysis+for+bridge+to+transplantation+with+the+CardioWest+total+artificial+heart%5BTitle%5D)+AND+%22Ann+Thorac+Surg%22%5BJournal%5D)">Risk factor analysis for bridge to transplantation with the CardioWest total artificial heart.</a> Ann Thorac Surg. 85, 1639-1644 (2008).</li>
<li>Kormos, R. L., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Right+ventricular+failure+in+patients+with+the+HeartMate+II+continuous-flow+left+ventricular+assist+device%3A+incidence%2C+risk+factors%2C+and+effect+on+outcomes%5BTitle%5D)+AND+%22J+Thorac+Cardiovasc+Surg%22%5BJournal%5D)">Right ventricular failure in patients with the HeartMate II continuous-flow left ventricular assist device: incidence, risk factors, and effect on outcomes.</a> J Thorac Cardiovasc Surg. 139, 1316-1324 (2010).</li>
<li>Fitzpatrick, J. R., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Early+planned+institution+of+biventricular+mechanical+circulatory+support+results+in+improved+outcomes+compared+with+delayed+conversion+of+a+left+ventricular+assist+device+to+a+biventricular+assist+device%5BTitle%5D)+AND+%22J+Thorac+Cardiovasc+Surg%22%5BJournal%5D)">Early planned institution of biventricular mechanical circulatory support results in improved outcomes compared with delayed conversion of a left ventricular assist device to a biventricular assist device.</a> J Thorac Cardiovasc Surg. 137, 971-977 (2009).</li>
<li>Matthews, J. C., Koelling, T. M., Pagani, F. D., Aaronson, K. D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((The+right+ventricular+failure+risk+score+a+pre-operative+tool+for+assessing+the+risk+of+right+ventricular+failure+in+left+ventricular+assist+device+candidates%5BTitle%5D)+AND+%22J+Am+Coll+Cardiol%22%5BJournal%5D)">The right ventricular failure risk score a pre-operative tool for assessing the risk of right ventricular failure in left ventricular assist device candidates.</a> J Am Coll Cardiol. 51, 2163-2172 (2008).</li>
<li>Ochiai, Y., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Predictors+of+Severe+Right+Ventricular+Failure+After+Implantable+Left+Ventricular+Assist+Device+Insertion%3A+Analysis+of+245+Patients%5BTitle%5D)+AND+%22Circulation%22%5BJournal%5D)">Predictors of Severe Right Ventricular Failure After Implantable Left Ventricular Assist Device Insertion: Analysis of 245 Patients.</a> Circulation. 106 (suppl I), (2002).</li>
<li>Drakos, S. G., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Risk+factors+predictive+of+right+ventricular+failure+after+left+ventricular+assist+device+implantation%5BTitle%5D)+AND+%22Am+J+Cardiol%22%5BJournal%5D)">Risk factors predictive of right ventricular failure after left ventricular assist device implantation.</a> Am J Cardiol. 105, 1030-1035 (2010).</li>
<li>Fitzpatrick, J. R., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Risk+score+derived+from+pre-operative+data+analysis+predicts+the+need+for+biventricular+mechanical+circulatory+support%5BTitle%5D)+AND+%22J+Heart+Lung+Transplant%22%5BJournal%5D)">Risk score derived from pre-operative data analysis predicts the need for biventricular mechanical circulatory support.</a> J Heart Lung Transplant. 27, 1286-1292 (2008).</li>
<li>Pettinari, M., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Are+right+ventricular+risk+scores+useful%5BTitle%5D)+AND+%22Eur+J+Cardiothorac+Surg%22%5BJournal%5D)">Are right ventricular risk scores useful.</a> Eur J Cardiothorac Surg. 42 (4), 1-6 (2012).</li>
<li>Arabia, F. A., Copeland, J. G., Pavie, A., Smith, R. G. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Implantation+Technique+for+the+CardioWest+Total+Artificial+Heart%5BTitle%5D)+AND+%22Ann+Thorac+Surg%22%5BJournal%5D)">Implantation Technique for the CardioWest Total Artificial Heart.</a> Ann Thorac Surg. 68, 698-704 (1999).</li>
<li>Copeland, J. G., Arabia, F. A., Smith, R. G., Covington, D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Synthetic+membrane+neopericardium+facilitates+total+artificial+heart+explantation%5BTitle%5D)+AND+%22J+Heart+Lung+Transplant%22%5BJournal%5D)">Synthetic membrane neopericardium facilitates total artificial heart explantation.</a> J Heart Lung Transplant. 20, 654-656 (2001).</li>
<li>Crouch, M. A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Successful+use+and+dosing+of+bivalirudin+after+temporary+total+artificial+heart+implantation%3A+a+case+series%5BTitle%5D)+AND+%22Pharmacotherapy%22%5BJournal%5D)">Successful use and dosing of bivalirudin after temporary total artificial heart implantation: a case series.</a> Pharmacotherapy. 28, 1413-1420 (2008).</li>
<li>Ensor, C. R., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Antithrombotic+therapy+for+the+CardioWest+temporary+total+artificial+heart%5BTitle%5D)+AND+%22Tex+Heart+Inst+J%22%5BJournal%5D)">Antithrombotic therapy for the CardioWest temporary total artificial heart.</a> Tex Heart Inst J. 37, 149-158 (2010).</li>
<li>Stribling, W. K., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Use+of+nesiritide+and+renal+function+following+total+artificial+heart+implantation%5BTitle%5D)+AND+%22J+Heart+Lung+Transplant%22%5BJournal%5D)">Use of nesiritide and renal function following total artificial heart implantation.</a> J Heart Lung Transplant. 30, 96(2011).</li>
<li>Shah, K. B., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Impact+of+low+dose+B-type+natriuretic+peptide+infusion+on+urine+output+after+total+artificial+heart+implantation%5BTitle%5D)+AND+%22J+Heart+Lung+Transplant%22%5BJournal%5D)">Impact of low dose B-type natriuretic peptide infusion on urine output after total artificial heart implantation.</a> J Heart Lung Transplant. 31 (6), 670-672 (2012).</li>
<li>Mankad, A. K., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Persistent+anemia+in+patients+supported+with+the+total+artificial+heart%3A+hemolysis+and+ineffective+erythropoiesis%5BTitle%5D)+AND+%22J+Card+Fail%22%5BJournal%5D)">Persistent anemia in patients supported with the total artificial heart: hemolysis and ineffective erythropoiesis.</a> J Card Fail. 17, 42-42 (2011).</li>
<li>Kohli, H. S., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Exercise+blood+pressure+response+during+assisted+circulatory+support%3A+comparison+of+the+total+artificial+heart+with+a+leftventricular+assist+device+during+rehabilitation%5BTitle%5D)+AND+%22J+Heart+Lung+Transplant%22%5BJournal%5D)">Exercise blood pressure response during assisted circulatory support: comparison of the total artificial heart with a leftventricular assist device during rehabilitation.</a> J Heart Lung Transplant. 30, 1207-1213 (2011).</li>
<li>Jaroszewski, D. E., Anderson, E. M., Pierce, C. N., Arabia, F. A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((The+SynCardia+freedom+driver%3A+a+portable+driver+for+discharge+home+with+the+total+artificial+heart%5BTitle%5D)+AND+%22J+Heart+Lung+Transplant%22%5BJournal%5D)">The SynCardia freedom driver: a portable driver for discharge home with the total artificial heart.</a> J Heart Lung Transplant. 30, 844-845 (2011).</li>
<li>Yankah, L., Shah, K. B., Hess, M. L., Kasirajan, V., Tang, D. G. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/pubmed?term=((Response+of+the+Syncardia+TAH+Pneumatic+Drivers+to+Afterload+Challenge+on+a+Mock+Loop%5BTitle%5D)+AND+%22ASAIO+Journal%22%5BJournal%5D)">Response of the Syncardia TAH Pneumatic Drivers to Afterload Challenge on a Mock Loop.</a> ASAIO Journal. 58 (7), (2012).</li>
</ol>

Production of this video-article was sponsored by SynCardia.&#160;MH and VK have served as consultants for Syncardia Systems Inc. The other authors have nothing to disclose.

Artificial replacement of the human heart has long captured the public&#39;s imagination. Early experience with the total artificial heart was marked by suboptimal outcomes1-3. The design and implantation techniques for the TAH used today have not changed significantly since Dr. DeVries&#39; original description6. However, refinements in patient selection (as a bridge to transplant) and understanding of perioperative management have led to significant improvement in outcomes. In 2004, a landmark study of 81 TAH implants was published. The trial established the efficacy of the TAH as a bridge to transplantation and led to FDA approval of the Syncardia TAH. In this nonrandomized study, 79% were successfully bridged to transplantation. Overall survival at 1 year was 70%. In a matched cohort of 35 patients who met study criteria but did not undergo TAH implantation, 46% survived to transplantation and 1 year survival was 31%7.
Patient selection is critical to good outcomes8,9. It is important to identify patients that have not yet developed irreversible end organ failure or other complications which would limit their likelihood for resuscitation or transplant candidacy. At our institution, findings of cirrhosis by liver biopsy, chronic dialysis dependency, or other psychosocial factors that would preclude transplant candidacy would also preclude candidacy for a TAH. Conversely, patients with acute decompensation or other evidence for potential end organ recovery are considered.
It is equally important to identify patients with biventricular failure whose right ventricular (RV) dysfunction will improve with isolated LV unloading and thus do not need biventricular circulatory support. RV failure following LVAD implantation is associated with increased morbidity and mortality10. Early use of biventricular support compared to delayed rescue for RV failure following LVAD is also associated with improved outcomes11. A number of risk factors for RV failure have been identified and several risk scoring systems have been developed. The need for inotropic / intra-aortic balloon pump support, evidence of renal and hepatic dysfunction (elevated creatinine, aspartate aminotransferase, bilirubin), hemodynamic evidence of RV dysfunction (decreased RV stroke work index, increased right atrial / wedge pressures), and echocardiographic evidence of RV dysfunction (RV dilatation, decreased RV ejection fraction / tricuspid annular motion, increased tricuspid regurgitation) have all been identified as risk factors12-15. Nonetheless, determination of risk for RV failure after LVAD placement remains difficult. One recent small series demonstrated no predictive value from several of the scoring systems in predicting the need for RV support16.
Timing of surgery is an important consideration. Once the decision has been made that biventricular mechanical support is necessary, early implantation offers the most effective way to restore blood flow and resuscitate a patient. However, patients can present abruptly with profound acute cardiogenic shock, severe malperfusion, and minimal prior evaluation. Liberal use of temporary support options (such as ECMO / IABP) for 24-48 hrs can start the process of resuscitation while questions regarding neurologic status or other questions of transplant candidacy are being answered. Prolonged use of high dose inotropic support may increase the risk for irreversible end organ failure or other complications.
The general techniques of implantation have not changed dramatically since the device was first introduced6,17. However, the benefits of taking the time to protect and maintain the pericardial space should be emphasized18. The device appears to incite an intense inflammatory thickening of the pericardium. Lining the pericardium with Goretex and maintaining the apical space with a saline implant greatly facilitates the re-entry for transplantation. Perioperative bleeding remains the most frequent perioperative complication. Packing the chest with delayed sternal closure is an effective strategy to limit the amount of perioperative blood products needed to reverse underlying coagulopathy and minimize the risk for tamponade. Despite the relatively rigid shell of the artificial ventricles it is possible for enough mediastinal fluid to accumulate and impede venous inflow causing tamponade. Surface echocardiography following TAH implantation has limited utility. CT imaging if often limited by underlying renal dysfunction and need to avoid IV contrast. We recommend early mediastinal re-exploration in any TAH patient who is otherwise doing poorly for unknown reasons.
Following implantation, the device is adjusted to maximize cardiac output. It is capable of generating an output &#62; 9 lpm. To minimize stasis, device parameters are adjusted for &#34;partial filling and complete eject.&#34; Typical early postoperative TAH parameters are: Left drive pressure 180-200 mmHg, right drive pressure 30-60 mmHg, HR 100-120 bpm, % systole 50, and vacuum 15 mmHg. In patients with long standing pulmonary hypertension, the higher RV drive pressures required for full right sided ejection may be detrimental. It is possible to &#34;overdrive&#34; the right sided output. In 2 patients, this resulted in profound pulmonary edema requiring temporary venovenous ECMO support. One patient had progressive multisystem organ failure and expired. The other was supported until the edema subsided and was successfully weaned off of ECMO.
Anticoagulation is generally initiated 24 hrs after chest closure. Patients are started on bivalirudin (0.005 mg/kg/h), aspirin (81 mg daily), and dipyridamole (50 mg tid). Outside of the operating room, heparin is avoided to minimize the risk of heparin induced thrombocytopenia. Bivalirudin is generally not titrated and once stable transitioned to oral warfarin. Goals of therapy are an INR 2-3 and platelet function 20-40% normal by optical aggregometry. Patients with evidence of increased hemolysis (LDH &#62; 1000) may benefit from the addition of pentoxifylline (400 mg TID)19,20.
Renal failure in acutely ill patients is clearly multifactorial. However, we have noticed a disproportionate tendency towards renal failure following TAH implantation. We hypothesize that this is in part related to the abrupt decrease in native natriuretic peptide production associated with ventricular excision. Perioperative supplementation with a low dose nesiritide infusion (0.005 mcg/kg/min) appears to reduce the incidence of renal failure21. Furthermore, infusion of nesiritide has a profound effect for increasing urine output after TAH implantation22. Once patients have recovered we have been able to discontinue the infusion in most patients. However, we have had a few patients who could not be weaned from the infusion until they were transplanted.
TAH patients often demonstrate significant chronic anemia. Causes include low grade hemolysis and ineffective erthryopoesis. Despite the anemia, TAH patients demonstrate good exertional tolerance and minimal symptoms even with hemoglobin concentrations of 5-6 g/dL. In order to avoid HLA sensitization and other associated complications, transfusions are avoided unless the patient is symptomatic or there are other sides of end organ malperfusion23.
Beyond the early postoperative period, care is focused on aggressive physical rehabilitation. Despite the severe presentation, the majority of patients were able to initiate physical therapy in the first postoperative week and most were able to start treadmill exercise by the second week. However, we have found that TAH patients demonstrate an abnormal blunting of the blood pressure response to exercise. This is in part related to the use of vasodilators to limit afterload24. While this could limit the amount of physical recovery, most patients go on to transplant before this is reached.
Until recently, TAH patients were hospital bound and tethered to a 418 lb console. As waiting times for donor organs continue to increase, this was accompanied by significantly reduced quality of life as well as increased financial costs. The introduction of a portable driver allowing discharge to home and even returning to work has been a major advance in the practical utility of the TAH. The Syncardia Freedom Driver (under clinical trial and not FDA approved) is a 14 lb, backpack sized driver with an electrically driven pneumatic piston25. Early experience with the driver has demonstrated that it is sensitive to afterload conditions and that an aggressive anti hypertensive drug regimen is necessary26.
In summary, current results have established the TAH as an effective device for resuscitation and subsequent bridge to transplantation. This cohort of patients represents an extreme end of the spectrum of end stage heart failure patients. Often there is no other suitable durable therapeutic option.

The first human implantation of a total artificial heart (TAH) in 1969 was performed by Denton Cooley in a 47 year old male who was unable to wean from cardiopulmonary bypass following left ventricular aneurysm repair. The experimental device provided hemodynamic support for 64 hr&#160;until a donor heart could be found. Although technically successful, device support was complicated by hemolysis and renal failure. The patient would go on to die from overwhelming sepsis 32 hr&#160;after transplantation1. A second attempt by Cooley in 1981 had similar unfortunate results2. In 1982, William DeVries performed the widely publicized permanent first implant of the Jarvik-7 TAH into a 61 year old dentist. The patient had a difficult postoperative course marked by recurrent respiratory failure, fracture of the prosthetic mitral valve strut requiring replacement of device, sepsis, stroke, intermittent renal failure, and bleeding related to anticoagulation. He ultimately succumbed after 112 days to pseudomembranous colitis3.
Despite these initial discouraging results, progressive refinement in device design, patient selection, and patient management have led to marked improvement in outcomes. The Jarvik-7 has since evolved into the Syncardia TAH, which remains the only FDA approved TAH in clinical use today. To date, over 1,000 implants have been performed worldwide4.
We present our institutional operative techniques in the context of a video case report.

<table><tbody><tr><td>Total artificial heart (implant kit)</td><td><a href="http://www.syncardia.com" target="_blank"><img src="/img/new_window.png"> Syncardia</a></td><td>500101</td><td></td></tr><tr><td>PRECLUDE pericardial membrane</td><td><a href="http://www.goremedical.com" target="_blank"><img src="/img/new_window.png"> Gore Medical</a></td><td>1PCM101</td><td></td></tr><tr><td>Smooth Round Saline Implant</td><td><a href="http://www.mentorwwllc.com" target="_blank"><img src="/img/new_window.png"> Mentor</a></td><td>350-1645</td><td></td></tr><tr><td>CoSeal Surgical Sealant</td><td><a href="http://www.ecomm.baxter.com/" target="_blank"><img src="/img/new_window.png"> Baxter</a></td><td>93407</td><td></td></tr></tbody></table>

implantation of the syncardia total artificial heart

With advances in technology, the use of mechanical circulatory support devices for end stage heart failure has rapidly increased. The vast majority of such patients are generally well served by left ventricular assist devices (LVADs). However, a subset of patients with late stage biventricular failure or other significant anatomic lesions are not adequately treated by isolated left ventricular mechanical support. Examples of concomitant cardiac pathology that may be better treated by resection and TAH replacement includes: post infarction ventricular septal defect,&#160;aortic root aneurysm / dissection, cardiac allograft failure, massive ventricular thrombus, refractory malignant arrhythmias (independent of filling pressures), hypertrophic / restrictive cardiomyopathy, and complex congenital heart disease. Patients often present with cardiogenic shock and multi system organ dysfunction. Excision of both ventricles and orthotopic replacement with a total artificial heart (TAH) is an effective, albeit extreme, therapy for rapid restoration of blood flow and resuscitation. Perioperative management is focused on end organ resuscitation and physical rehabilitation. In addition to the usual concerns of infection, bleeding, and thromboembolism common to all mechanically supported patients, TAH patients face unique risks with regard to renal failure and anemia. Supplementation of the abrupt decrease in brain natriuretic peptide following ventriculectomy appears to have protective renal effects. Anemia following TAH implantation can be profound and persistent. Nonetheless, the anemia is generally well tolerated and transfusion are limited to avoid HLA sensitization. Until recently, TAH patients were confined as inpatients tethered to a 500 lb pneumatic console driver. Recent introduction of a backpack sized portable driver (currently under clinical trial) has enabled patients to be discharged home and even return to work. Despite the profound presentation of these sick patients, there is a 79-87% success in bridge to transplantation.

From April 2006 through July 2012, 66 patients were implanted with a TAH at Virginia Commonwealth University Medical Center. Patients were critically ill: 18% were on other mechanical support (ECMO, LVAD, or BiVAD), 58% were on an intra-aortic balloon pump, 58% were on inotropic medications, 17% were mechanically ventilated, and 17% were on hemodialysis. Patients were supported for a total of 7863 days. Median duration of support was 87.5 days (range 1 to 602 days). 10 patients were discharged home on a portable discharge driver (as part of a clinical trial, not FDA approved). 50 (76%) patients were successfully bridged to transplantation, 7 (11%) remained on the device awaiting transplantation, and 9 (14%) died while on the device (Figure 10). 3 of the deaths occurred in the 1st week following implantation and were related to progressive multisystem organ failure. The other 6 deaths occurred from 32 to 169 days post implant (3 sepsis / MSOF, 1 mediastinal bleeding, 1 intracranial hemorrhage, and 1 hypertensive crisis). The most frequent perioperative adverse event was bleeding requiring mediastinal re-exploration in 30%.
<img alt="Artificial heart implant setup, medical equipment, cardiac support system components on surgical table." fo:content-width="5in" src="/files/ftp_upload/50377/50377fig1highres.jpg" width="500" data-altupdatedat="1747911167000" data-alt="Figure 1"> 
Figure 1. The Syncardia total artificial heart.
<img alt="CT scan showing mediastinal measurement of 12.6 cm, indicating potential cardiomegaly diagnosis." fo:content-width="4in" src="/files/ftp_upload/50377/50377fig2highres.jpg" width="400" data-altupdatedat="1747911167000" data-alt="Figure 2"> 
Figure 2. Measuring AP dimension by CT. A space &gt; 10 cm between the sternum and the anterior border of the 10th vertebral body is generally required for the device to fit.
<img alt="Medical procedure with green gloves using syringe and surgical tools on sterile surface." fo:content-width="4in" src="/files/ftp_upload/50377/50377fig3highres.jpg" width="400" data-altupdatedat="1747911167000" data-alt="Figure 3"> 
Figure 3. Pretreating the arterial outflow grafts. The aortic and pulmonary artery grafts are presealed with Coseal Surgical Sealant, a synthetic hydrogel used as an adjunctive sealant for vascular grafts. Previously the grafts were preclotted with patient's own blood prior to heparinization.
<img alt="Heart surgery illustration and operation; grafts, coronary bypass procedure, medical study." fo:content-width="5in" src="/files/ftp_upload/50377/50377fig4highres.jpg" width="500" data-altupdatedat="1747911167000" data-alt="Figure 4"> 
Figure 4. Excision of the right and left ventricle. The RV and LV are excised leaving a 1 cm ventricular cuff beyond the mitral and tricuspid annulus. Arrows point to the incision along the anterior wall of the RV. The incisions are extended through the left and right ventricular outflow tracts and through the aortic and pulmonic valves.
<img alt="Surgical procedure demonstrating heart anatomy with focus on valve repair in clinical setting." fo:content-width="5in" src="/files/ftp_upload/50377/50377fig5highres.jpg" width="500" data-altupdatedat="1747911167000" data-alt="Figure 5"> 
Figure 5. Oversewing the coronary sinus. The coronary sinus (arrow) is oversewn through the RV cuff (the tricuspid leaflets have been excised) for hemostasis.
<img alt="Surgical procedure on animal tissue illustrating internal anatomy and surgical tools." fo:content-width="5in" src="/files/ftp_upload/50377/50377fig6highres.jpg" width="500" data-altupdatedat="1747911167000" data-alt="Figure 6"> 
Figure 6. Ligating atrial appendage. The left atrial appendage is ligated with a Seamguard-reinforced endo GIA stapler to minimize a potential source for systemic emboli.
<img alt="Surgical heart procedure setup showing open-heart surgery tools and techniques for bypass operation." src="/files/ftp_upload/50377/50377fig7.jpg" data-altupdatedat="1747911167000" data-alt="Figure 7"> 
Figure 7. Quick connects and Goretex Preclude implanted. The atrial quick connects and vascular grafts are sewn to their respective orifices. The pericardium is lined with Goretex membrane to facilitate subsequent reentry for transplantation.
<img alt="Artificial heart implantation surgery, showing device placement in surgical procedure." src="/files/ftp_upload/50377/50377fig8highres.jpg" data-altupdatedat="1747911167000" data-alt="Figure 8"> 
Figure 8. Device implanted. The device implanted just prior to chest closure. 
<img alt="Chest X-ray and CT scan showing internal devices, medical illustration, and drainage setup." fo:content-width="5in" src="/files/ftp_upload/50377/50377fig9highres.jpg" width="500" data-altupdatedat="1747911167000" data-alt="Figure 9"> 
Figure 9. Pericardial apical saline implant as demonstrated on CT imaging and CXR. A saline implant (single arrows) is used to maintain the pericardial apical space for transplantation. In the CXR, the edge of the TAH (where the pericardium would otherwise contract) is delineated by the central air bubble (double arrows).
<img alt="Survival analysis Kaplan-Meier graph; comparing overall survival vs. survival to transplantation." src="/files/ftp_upload/50377/50377fig10.jpg" data-altupdatedat="1747911167000" data-alt="Figure 10"> 
Figure 10. VCU Outcomes. Kaplan-Meier survival curves demonstrating survival to transplantation and overall survival following TAH implant.

Watch this Scientific Journal Video about Implantation of the Syncardia Total Artificial Heart at JoVE.com

Implantation of the Syncardia Total Artificial Heart

The purpose of this manuscript is to briefly review indications, management, and outcomes for the total artificial heart. Video operative techniques for device implantation are presented.

With advances in technology, the use of mechanical circulatory support devices for end stage heart failure has rapidly increased. The vast majority of ...

implantation-of-the-syncardia-total-artificial-heart

Research

JoVE Journal

Medicine

35.2K Views.  Virginia Commonwealth University.  Het doel van dit manuscript is om kort beoordelen indicaties, het beheer, en de resultaten voor de totale kunsthart. Video operatieve technieken voor implantatie worden gepresenteerd. 

Video: Implantation of the Syncardia Total Artificial Heart

A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and  Ease of Implantation

Implantable cardioverter-defibrillators (ICDs) terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) with high efficacy and can protect patients from sudden cardiac death (SCD). However, inappropriate shocks may occur if tachycardias are misdiagnosed. Inappropriate shocks are harmful and impair patient quality of life. The risk of inappropriate therapy increases with lower detection rates programmed in the ICD. Single-chamber detection poses greater risks for misdiagnosis when compared with dual-chamber devices that have the benefit of additional atrial information. However, using a dual-chamber device merely for the sake of detection is generally not accepted, since the risks associated with the second electrode may outweigh the benefits of detection. Therefore, BIOTRONIK developed a ventricular lead called the LinoxSMART S DX, which allows for the detection of atrial signals from two electrodes positioned at the atrial part of the ventricular electrode. This device contains two ring electrodes; one that contacts the atrial wall at the junction of the superior vena cava (SVC) and one positioned at the free floating part of the electrode in the atrium. The excellent signal quality can only be achieved by a special filter setting in the ICD (Lumax 540 and 740 VR-T DX, BIOTRONIK). Here, the ease of implantation of the system will be demonstrated.

Dual-chamber implantable cardioverter-defibrillators (ICDs) may improve detection of atrial fibrillation as well as differentiation of tachycardias. However, this advantage is undermined by complications associated with the second electrode, which is required in conventional dual chamber devices. Therefore, BIOTRONIK has developed a new electrode called the LinoxSMART S DX that, when used in conjunction with the Lumax DX ICD, offers dual-chamber detection without the risks associated with the second electrode.

Implantable cardioverter-defibrillators (ICDs) terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) with high efficacy and can protect ...

Implantation of Engineered Tissue in the Rat Heart

Rodent surgery is often an important component in assessing the utility of engineered tissues. A wide variety of surgical procedures can be performed in common laboratory rats or mice and these quite frequently serve as an intermediate step between bench-top experiments and large animal testing or human trials. Given that rodents provide an established, cost-effective, and physiologically-relevant model system in which to test novel combinations of scaffolding materials and cells, they are particularly well-suited for cardiovascular tissue engineering studies. Presently, we describe an open-heart surgical procedure to implant engineered tissue containing myogenic progenitor cells in the atrioventricular (AV) groove of a rat heart. These implants are intended to create an electrical conduit between the right atrium and right ventricle with the ultimate goal of providing an alternative treatment to conventional pacemaker implantation in pediatric patients with complete heart block[1]. The engineered tissue is implanted in the AV-groove by means of a thoracotomy. For our purposes, Lewis rats are anesthetized and invasively ventilated to maintain positive airway pressure during the sterile surgical procedure. The approach to the heart is performed by a right thoracotomy through an antero-lateral incision at the 5th intercostal space. The tissue construct is fixed in the AV groove using a single 7-0 Prolene suture and positioned between the right ventricle and atrium at the ventral portion of the heart. The epicardium is partially removed to allow direct contact between the recipient myocardial cells and those contained in the engineered tissue. Following implantation, the chest wall is closed in layers, any pneumothorax is evacuated, and the animal is extubated and treated with analgesic.

Here, we describe a cardiac surgical procedure to implant engineered tissue in the atrioventricular (AV)-groove of an adult Lewis rat.

Rodent surgery is often an important component in assessing the utility of engineered tissues. A wide variety of surgical procedures can be performed in ...

Biology

Implantation of Total Artificial Heart in Congenital Heart Disease

In patients with end-stage heart failure (HF), a total artificial heart (TAH) may be implanted as a bridge to cardiac transplant. However, in congenital heart disease (CHD), the malformed heart presents a challenge to TAH implantation. 
In the case presented here, a 17 year-old patient with congenital transposition of the great arteries (CCTGA) experienced progressively worsening HF due to his congenital condition. He was hospitalized multiple times and received an implantable cardioverter defibrillator (ICD). However, his condition soon deteriorated to end-stage HF with multisystem organ failure. 
Due to the patient's grave clinical condition and the presence of complex cardiac lesions, the decision was made to proceed with a TAH. The abnormal arrangement of the patient's ventricles and great arteries required modifications to the TAH during implantation.
With the TAH in place, the patient was able to return home and regain strength and physical well-being while awaiting a donor heart. He was successfully bridged to heart transplantation 5 months after receiving the device. This report highlights the TAH is feasible even in patients with structurally abnormal hearts, with technical modification.

This is a case report of a patient with congenitally corrected transposition of the great arteries (CCTGA) who received a total artificial heart (TAH) as a bridge to heart transplant. The TAH was successfully implanted with modifications to accommodate the patient's congenitally malformed heart.

In patients with end-stage heart failure (HF), a total artificial heart (TAH) may be implanted as a bridge to cardiac transplant. However, in congenital ...

Testing the Efficacy of Pharmacological Agents in a Pericardial Target Delivery Model in the Swine

To date, many pharmacological agents used to treat or prevent arrhythmias in open-heart cases create undesired systemic side effects. For example, antiarrhythmic drugs administered intravenously can produce drops in systemic pressure in the already compromised cardiac patient. While performing open-heart procedures, surgeons will often either create a small port or form a pericardial cradle to create suitable fields for operation. This access yields opportunities for target pharmacological delivery (antiarrhythmic or ischemic preconditioning agents) directly to the myocardial tissue without undesired side effects.
We have developed a swine model for testing pharmacological agents for target delivery within the pericardial fluid. While fully anesthetized, each animal was instrumented with a Swan-Ganz catheter as well as left and right ventricle pressure catheters, and pacing leads were placed in the right atrial appendage and the right ventricle. A medial sternotomy was then performed and a pericardial access cradle was created; a plunge pacing lead was placed in the left atrial appendage and a bipolar pacing lead was placed in the left ventricle. Utilizing a programmer and a cardiac mapping system, the refractory period of the atrioventricular node (AVN), atria and ventricles was determined. In addition, atrial fibrillation (AF) induction was produced utilizing a Grass stimulator and time in AF was observed. These measurements were performed prior to treatment, as well as 30 min&#160;and 60 min&#160;after pericardial treatment. Additional time points were added for selected studies. The heart was then cardiopleged and reanimated in a four chamber working mode. Pressure measurements and function were recorded for 1 hr after reanimation. This treatment strategy model allowed us to observe the effects of pharmacological agents that may decrease the incidence of cardiac arrhythmias and/or ischemic damage, during and after open-heart surgery.

We have developed a swine model for the target delivery of pharmacological agents within the pericardial space/fluid. Using this approach, the relative benefits of administered agents on induced atrial fibrillation, relative refractory periods and/or ischemic protection can be investigated.

To date, many pharmacological agents used to treat or prevent arrhythmias in open-heart cases create undesired systemic side effects. For example, ...

Use of Two Intracorporeal Ventricular Assist Devices As a Total Artificial Heart

Mechanical circulatory support (MCS) has been introduced as a viable alternative to heart transplantation primarily through the use of intracorporeal ventricular assist devices (VADs) for support of the left ventricle. However, certain clinical scenarios warrant biventricular mechanical support. One strategy for some patients is the excision of both ventricles and the implantation of two VAD pumps as a total artificial heart (TAH). This has recently been made possible by the improvements in device design and the small profile of centrifugal devices. This TAH approach remains experimental with many important challenges such as the device settings to balance the right and left circulation, the orientation of the devices and the outflow graft with their influence on hemolysis and stability, and the outcome of chronic support using such an orientation. This protocol aims to provide a reproducible approach for total artificial heart replacement with two intracorporeal centrifugal VADs in a cow model.

Here, we present a protocol using two centrifugal pumps as a total artificial heart replacement.

Mechanical circulatory support (MCS) has been introduced as a viable alternative to heart transplantation primarily through the use of intracorporeal ...

An Immunological Model for Heterotopic Heart and Cardiac Muscle Cell Transplantation in Rats

Heterotopic heart transplantation in rats has been a commonly used model for diverse immunological studies for more than 50 years. Several modifications have been reported since the first description in 1964. After 30 years of performing heterotopic heart transplantation in rats, we have developed a simplified surgical approach, which can be easily taught and performed without further surgical training or background.
After dissection of the ascending aorta and the pulmonary artery and ligation of superior and inferior caval and pulmonary veins, the donor heart is harvested and subsequently perfused with ice-cold saline solution supplemented with heparin. After clamping and incising the recipient abdominal vessels, the donor ascending aorta and pulmonary artery are anastomosed to the recipient abdominal aorta and inferior vena cava, respectively, using continuous running sutures.
Depending on different donor-recipient combinations, this model allows analyses of either acute or chronic rejection of allografts. The immunological significance of this model is further enhanced by a novel approach of in-ear injection of vital cardiac muscle cells and subsequent analysis of draining cervical lymphatic tissue.

We describe a model of heterotopic abdominal heart transplantation in rats, implying modifications of current strategies, which lead to a simplified surgical approach. Additionally, we describe a novel rejection model by in-ear injection of vital cardiac muscle cells, allowing further transplant immunological analyses in rats.

Heterotopic heart transplantation in rats has been a commonly used model for diverse immunological studies for more than 50 years. Several modifications ...

Immunology and Infection

A Pre-Clinical Porcine Model of Orthotopic Heart Transplantation

Fifty-years following the first successful report, cardiac transplantation remains the gold-standard treatment for eligible patients with advanced heart failure. Multiple small-animal models of heart transplantation have been used to study the acute and long-term effects of novel therapies. However, few are tested and demonstrated success in clinical trials. It is of critical importance to evaluate new therapies in a clinically relevant large-animal model for efficient and reliable translation of basic studies&#39;&#160;findings. Here, we describe a pre-clinical large-animal (porcine) model of orthotopic heart transplantation that has been firmly established and previously used to investigate novel cardioprotective strategies. This procedure focuses on acute ischemia-reperfusion injury and is a reliable method to investigate novel interventions which have been tested and validated in smaller experimental models, such as the murine model. We demonstrate its usefulness in assessing cardiac performance during the early post-transplantation period and other potential possibilities enabled by the model.

Here, we describe a pre-clinical large-animal (porcine) model of orthotopic heart transplantation that has been firmly established and utilized to investigate novel cardioprotective strategies.

Fifty-years following the first successful report, cardiac transplantation remains the gold-standard treatment for eligible patients with advanced heart ...

Establishing a Swine Model of Post-myocardial Infarction Heart Failure for Stem Cell Treatment

Although advances have been achieved in the treatment of heart failure (HF) following myocardial infarction (MI), HF following MI remains one of the major causes of mortality and morbidity around the world. Cell-based therapies for cardiac repair and improvement of left ventricular function after MI have attracted considerable attention. Accordingly, the safety and efficacy of these cell transplantations should be tested in a preclinical large animal model of HF prior to clinical use. Pigs are widely used for cardiovascular disease research due to their similarity to humans in terms of heart size and coronary anatomy. Therefore, we sought to present an effective protocol for the establishment of a porcine chronic HF model using closed-chest coronary balloon occlusion of the left circumflex artery (LCX), followed by rapid ventricular pacing induced with pacemaker implantation. Eight weeks later, the stem cells were administered by intramyocardial injection in the peri-infarct area. Then the infarct size, cell survival, and left ventricular function (including echocardiography, hemodynamic parameters, and electrophysiology) were evaluated. This study helps establish a stable preclinical large animal HF model for stem cell treatment.

We sought to establish a swine model of heart failure induced by left circumflex artery blockage and rapid pacing to test the effect and safety of intramyocardial administration of stem cells for cell-based therapies.

Although advances have been achieved in the treatment of heart failure (HF) following myocardial infarction (MI), HF following MI remains one of the major ...

Use of a Percutaneous Ventricular Assist Device/Left Atrium to Femoral Artery Bypass System for Cardiogenic Shock

The left atrial to femoral artery bypass (LAFAB) system is a mechanical circulatory support (MCS) device used in cardiogenic shock (CS) that bypasses the left ventricle by draining blood from the left atrium (LA) and returning it to the systemic arterial circulation via the femoral artery. It can provide flows ranging from 2.5-5 L/min depending on the size of the cannula. Here, we discuss the mechanism of action of LAFAB, available clinical data, indications for its use in cardiogenic shock, steps of implantation, post-procedural care, and complications associated with the use of this device and their management.
We also provide a brief video of the procedural component of device therapy, including the pre-placement preparation, percutaneous placement of the device via transseptal puncture under echocardiographic guidance and the post-operative management of device parameters.

The following article describes the stepwise procedure for placement of a device (e.g., Tandemheart) in cardiogenic shock (CS) that is a percutaneous left ventricular assist device (pLVAD) and a left atrial to femoral artery bypass (LAFAB) system that bypasses and supports the left ventricle (LV) in CS.

The left atrial to femoral artery bypass (LAFAB) system is a mechanical circulatory support (MCS) device used in cardiogenic shock (CS) that bypasses the ...

A Porcine Heterotopic Heart Transplantation Protocol for Delivery of Therapeutics to a Cardiac Allograft

Cardiac transplantation is the gold standard treatment for end-stage heart failure. However, it remains limited by the number of available donor hearts and complications such as primary graft dysfunction and graft rejection. The recent clinical use of an ex vivo perfusion device in cardiac transplantation introduces a unique opportunity for treating cardiac allografts with therapeutic interventions to improve function and avoid deleterious recipient responses. Establishing a translational, large-animal model for therapeutic delivery to the entire allograft is essential for testing novel therapeutic approaches in cardiac transplantation. The porcine, heterotopic heart transplantation model in the intraabdominal position serves as an excellent model for assessing the effects of novel interventions and the immunopathology of graft rejection. This model additionally offers long-term survival for the pig, given that the graft is not required to maintain the recipient's circulation. The aim of this protocol is to provide a reproducible and robust approach for achieving ex vivo delivery of a therapeutic to the entire cardiac allograft prior to transplantation and provide technical details to perform a survival heterotopic transplant of the ex vivo perfused heart.

We present a protocol for utilizing a normothermic ex vivo sanguinous perfusion system for the delivery of therapeutics to an entire cardiac allograft in a porcine heterotopic heart transplant model.

Cardiac transplantation is the gold standard treatment for end-stage heart failure. However, it remains limited by the number of available donor hearts ...

Implantation of the Syncardia Total Artificial Heart

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