M. Strueber

The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: Executive summary

Institutional Affiliations Co-chairs Feldman D: Minneapolis Heart Institute, Minneapolis, Minnesota, Georgia Institute of Technology and Morehouse School of Medicine; Pamboukian SV: University of Alabama at Birmingham, Birmingham, Alabama; Teuteberg JJ: University of Pittsburgh, Pittsburgh, Pennsylvania Task force chairs Birks E: University of Louisville, Louisville, Kentucky; Lietz K: Loyola University, Chicago, Maywood, Illinois; Moore SA: Massachusetts General Hospital, Boston, Massachusetts; Morgan JA: Henry Ford Hospital, Detroit, Michigan Contributing writers Arabia F: Mayo Clinic Arizona, Phoenix, Arizona; Bauman ME: University of Alberta, Alberta, Canada; Buchholz HW: University of Alberta, Stollery Children’s Hospital and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada; Deng M: University of California at Los Angeles, Los Angeles, California; Dickstein ML: Columbia University, New York, New York; El-Banayosy A: Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania; Elliot T: Inova Fairfax, Falls Church, Virginia; Goldstein DJ: Montefiore Medical Center, New York, New York; Grady KL: Northwestern University, Chicago, Illinois; Jones K: Alfred Hospital, Melbourne, Australia; Hryniewicz K: Minneapolis Heart Institute, Minneapolis, Minnesota; John R: University of Minnesota, Minneapolis, Minnesota; Kaan A: St. Paul’s Hospital, Vancouver, British Columbia, Canada; Kusne S: Mayo Clinic Arizona, Phoenix, Arizona; Loebe M: Methodist Hospital, Houston, Texas; Massicotte P: University of Alberta, Stollery Children’s Hospital, Edmonton, Alberta, Canada; Moazami N: Minneapolis Heart Institute, Minneapolis, Minnesota; Mohacsi P: University Hospital, Bern, Switzerland; Mooney M: Sentara Norfolk, Virginia Beach, Virginia; Nelson T: Mayo Clinic Arizona, Phoenix, Arizona; Pagani F: University of Michigan, Ann Arbor, Michigan; Perry W: Integris Baptist Health Care, Oklahoma City, Oklahoma; Potapov EV: Deutsches Herzzentrum Berlin, Berlin, Germany; Rame JE: University of Pennsylvania, Philadelphia, Pennsylvania; Russell SD: Johns Hopkins, Baltimore, Maryland; Sorensen EN: University of Maryland, Baltimore, Maryland; Sun B: Minneapolis Heart Institute, Minneapolis, Minnesota; Strueber M: Hannover Medical School, Hanover, Germany Independent reviewers Mangi AA: Yale University School of Medicine, New Haven, Connecticut; Petty MG: University of Minnesota Medical Center, Fairview, Minneapolis, Minnesota; Rogers J: Duke University Medical Center, Durham, North Carolina

Acquired von Willebrand Syndrome in Patients with an Axial Flow Left Ventricular Assist Device

Background—Rotary blood pumps used as left ventricular assist devices (LVADs) allow for long-term support and may become suitable alternatives to heart transplantation. Effects of this technology on the coagulation system are not completely understood, leading to controversial anticoagulation protocols. Thus, we investigated the primary hemostasis in patients with chronic LVAD therapy. Methods and Results—Twenty-six outpatients received axial flow LVAD (HeartMate II; Thoratec) for a median support time of 4.5 months. In a cross-sectional protocol, platelet aggregation in response to ADP and epinephrine, von Willebrand antigen (vWF:AG), and collagen-binding capacity (vWF:CB) were obtained. Von Willebrand factor (vWF) multimer analyses were performed, and patients were screened for bleeding events. This analysis was repeated after removal of the device for transplantation or recovery (n=12) and after a median of 15.5 months in ongoing patients (n=11). In all patients on devices, severe impairment of platelet aggregation as well as a loss of large vWF multimers were found. In 10 patients, a decreased vWF:CB/vWF:AG ratio was observed. Bleeding episodes occurred with an incidence of 0.17 per patient-year. After removal of the device, normal patterns of platelet aggregation, multimer analysis, and vWF:CB/vWF:AG ratio were recorded. In the second analysis of ongoing patients, impairment of platelet aggregation and loss of large vWF multimers were verified. Conclusions—A diagnosis of von Willebrand syndrome type 2 was established in all patients after LVAD implantation, and bleeding events confirmed this finding. Reversibility of this condition was found after removal of the device.

Multicenter evaluation of an intrapericardial left ventricular assist system

OBJECTIVES The aim of this study was to conduct an initial clinical evaluation of the new HeartWare Ventricular Assist System (HeartWare, Inc., Framingham, Massachusetts) in a multicenter, prospective, nonrandomized single-arm clinical trial. BACKGROUND Heart failure is a worldwide epidemic. The effectiveness of heart transplantation and medical therapy is limited, resulting in the emergence of mechanical circulatory support as a primary treatment for end-stage heart disease. Left ventricular assist devices that use rotary pumps are small and durable, which might reduce morbidity and mortality during support. METHODS Fifty heart transplant candidates with New York Heart Association functional class IV symptoms were supported at 5 international centers by the HeartWare System for 180 days, until heart transplant, myocardial recovery and device explant, or death. Patients who continue to be supported have been followed for a minimum of 2 years. RESULTS Of the 50 patients, 20 (40%) received transplants, 4 (8%) had the pump explanted after myocardial recovery, and 17 (34%) continue support at 2 years. Nine (18%) patients died during support from sepsis (n = 3), multiple organ failure (n = 3), or hemorrhagic stroke (n = 3). The actual survival at 6, 12, and 24 months was 90%, 84%, and 79%, respectively. In the survivors, measures of quality of life showed a significant improvement over baseline values. Significant improvements were found for recognition memory at 3 months after implant (p = 0.006). The most frequent adverse events were infection and bleeding. CONCLUSIONS Patients with end-stage heart failure can be safely and effectively supported by the HeartWare Ventricular Assist System with improved quality of life and neurocognitive function.

Extracorporeal Membrane Oxygenation in Nonintubated Patients as Bridge to Lung Transplantation

We report on the use of veno‐arterial extracorporeal membrane oxygenation (ECMO) as a bridging strategy to lung transplantation in awake and spontaneously breathing patients. All five patients described in this series presented with cardiopulmonary failure due to pulmonary hypertension with or without concomitant lung disease. ECMO insertion was performed under local anesthesia without sedation and resulted in immediate stabilization of hemodynamics and gas exchange as well as recovery from secondary organ dysfunction. Two patients later required endotracheal intubation because of bleeding complications and both of them eventually died. The other three patients remained awake on ECMO support for 18–35 days until the time of transplantation. These patients were able to breathe spontaneously, to eat and drink, and they received passive and active physiotherapy as well as psychological support. All of them made a full recovery after transplantation, which demonstrates the feasibility of using ECMO support in nonintubated patients with cardiopulmonary failure as a bridging strategy to lung transplantation.

Bridge to Thoracic Organ Transplantation in Patients with Pulmonary Arterial Hypertension Using a Pumpless Lung Assist Device

We describe a novel technique of pumpless extracorporeal life support in four patients with cardiogenic shock due to end‐stage pulmonary hypertension (PH) including patients with veno‐occlusive disease (PVOD) using a pumpless lung assist device (LAD). The device was connected via the pulmonary arterial main trunk and the left atrium, thereby creating a septostomy‐like shunt with the unique addition of gas exchange abilities in parallel to the lung. Using this approach, all four patients were successfully bridged to bilateral lung transplantation and combined heart–lung transplantation, respectively. Although all patients presented in cardiogenic shock, hemodynamic unloading of the right ventricle using the low‐resistance LAD stabilized the hemodynamic situation immediately so that no pump support was subsequently required.

Initial clinical experience with a novel left ventricular assist device with a magnetically levitated rotor in a multi-institutional trial

BACKGROUND Third-generation rotary blood pumps have magnetically levitated rotors that eliminate mechanical wear over the years. Together with their potential for miniaturization, these pumps seem suitable for long-term support of patients with a wide range of body surface areas (BSA). Recently, the novel HVAD pump (HeartWare Inc, Framingham, MA), a miniaturized centrifugal pump with a hydrodynamic, magnetically levitated rotor, became ready for clinical application. METHODS In a multi-institutional trial in Europe and Australia, 23 patients (mean age, 47.9 ± 12 years) in end-stage heart failure were enrolled in 5 centers. The primary end point of the bridge-to-transplant study was survival to heart transplant or survival to 180 days on the device, whichever occurred first. Follow-up data at 1 year are presented. The small size of the device allows for intrapericardial placement of the pump. RESULTS Implant procedures were generally fast and uneventful. Mean duration of support was 167 ± 143 days (range, 13-425 days), and mean blood flow provided by the pump was 6.1 ± 1.1 liters/min. At the 180-day end point, 2 patients had undergone successful transplant at 157 and 175 days, 2 patients died while on the device, and 19 patients continued pump support for more than 180 days. Actuarial survival after 6 months was 91% and was 86% at the 1-year follow-up. CONCLUSIONS The design of the HVAD pump enables a quick and less invasive implantation. The results to date demonstrate satisfactory long-term survival with excellent quality of life in this cohort of 23 patients of the initial multi-institutional Conformité Européene (CE) mark trial.

Successful use of the HeartWare HVAD rotary blood pump for biventricular support

Left ventricular assist devices (LVADs) using rotary blood pump technology led to significant improvement of results in left ventricular failure. 1 However, patients with concomitant right ventricular failure have not benefited from this new technology so far. We report on the first successful use of 2 HeartWare HVAD centrifugal pumps (HeartWare International, Inc, Framingham, Mass) in biventricular support. CLINICAL SUMMARY A 56-year-old man was referred to our institution after massive myocardial infarction owing to occlusion of the left anterior descending coronary artery (LAD) (maximum creatine kinase MB 1300 units). He had been treated with grafts to the LAD, the first diagonal, and the right coronary artery (RCA) and was in cardiogenic shock. An intra-aortic balloon pump (IABP) and a femorofemoral extracorporeal membrane oxygenator (ECMO) were implanted after weaning from extracorporeal circulation failed. The patient was transported to our center after 2 days in an extubated stable state. An LVAD was implanted using a standard approach under ECMO support. All bypass grafts were intact; however, right ventricular dysfunction led to the decision not to explant the ECMO or the IABP at this time. The IABP was removed the following day, and the ECMO was explanted on postoperative day 4 when renal and liver parameters remained normal. The patient was treated with phosphodiesterase inhibitor and nitric oxide. Sedation was instituted for another 3 days, and then weaning from ventilatory support was started. At this time the compensated right ventricular insufficiency turned into refractory right ventricular failure inducing renal insufficiency and impairment of liver function. A new ECMO was inserted on postoperative day 11. Again, end-organ function recovered, but right heart failure persisted as indicated by echocardiographic findings for another 10 days, and the decision was made to implant a second HVAD device to support the right ventricle. With the patient still supported by ECMO, the anterior wall of the right ventricle was chosen for implantion of the inflow of the device. The sewing ring was placed epicardially. Care was taken not to insert the whole length of the inflow cannula, but only about 1 cm into the cavity of the ventricle. The location of the device was stabilized by the epicardial sewing ring. The bend relief was removed and after partial clamping the outflow graft was sewn end to side to the main pulmonary artery (Figure 1). For continuous pressure monitoring, a catheter was inserted into the left atrium (LA). The LVAD was set to relativey high speed (3600 rpm) and the right ventricular assist device (RVAD) was started at a pump speed of 2000 rpm. TheECMOcouldbestoppedandremoved.Therewerestable circulatory conditions with a pump flow of 4.5 to 5.5 L/min on the LVAD and an LA pressure between 3 and 9 mm Hg. After the start of spontaneous breathing, the pump flow on the RVAD changed by the breathing pattern, with very high

Implantation of a centrifugal pump as a left ventricular assist device through a novel, minimized approach: Upper hemisternotomy combined with anterolateral thoracotomy

From the Department of Cardiac, Thoracic, Transplantation and Vascular Surgery and the Department of Anaesthesiology and Intensive Care, Hannover Medical School, Hannover, Germany. Disclosures: Authors have nothing to disclose with regard to commercial support. Received for publication June 7, 2011; revisions received July 12, 2011; accepted for publication July 22, 2011; available ahead of print Sept 8, 2011. Address for reprints: Jan D. Schmitto, MD, PhD, Department of Cardiac, Transplantation, Thoracic and Vascular Surgery, Hannover Medical School, Carl-NeubergStrasse 1, 30625 Hannover, Germany (E-mail: schmitto.jan@mh-hannover.de). J Thorac Cardiovasc Surg 2012;143:511-3 0022-5223/

Indications for and outcomes after combined lung and liver transplantation: a single-center experience on 13 consecutive cases.

36.00 Copyright 2012 by The American Association for Thoracic Surgery doi:10.1016/j.jtcvs.2011.07.046

Health-related quality of life and exercise tolerance in recipients of heart transplants and left ventricular assist devices: A prospective, comparative study

Background. Combined lung and liver transplantation (Lu-LTx) is a therapeutic option for selected patients with coexisting lung and liver disease. For several reasons, Lu-LTx is performed in few centers and information about the technical issues, posttransplant management and long-term outcomes associated with this procedure is limited. Methods. We analyzed data from 13 consecutive patients who underwent combined Lu-LTx at Hannover Medical School (Hannover, Germany) between April 1999 and December 2003. The main indications were cystic fibrosis, &agr;1-proteinase inhibitor deficiency and portopulmonary hypertension. All patients had advanced cirrhosis and severe pulmonary disease manifestation. Results. Ten patients received a sequential double Lu-LTx, one patient received a single Lu-LTx, one received a double lung and split liver transplantation, and one received an en-bloc heart-lung and liver translantation. Immunosuppression was based on cyclosporine in a triple/quadruple regimen. Postoperative surgical complications occurred in eight patients. There were two perioperative deaths; two patients died during the first year on day 67 and 354, respectively, and one patient died at month 53. The overall patient survival rates at 1, 3, and 5 years were 69%, 62%, and 49%, respectively. Conclusion. Combined Lu-LTx is a therapeutic option for highly selected patients with end-stage lung and liver disease with acceptable long-term outcome.