F. Arabia

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

Complications of Extracorporeal Membrane Oxygenation for Treatment of Cardiogenic Shock and Cardiac Arrest: A Meta-Analysis of 1,866 Adult Patients

BACKGROUND Venoarterial extracorporeal membrane oxygenation (ECMO) has been used successfully for treatment of cardiogenic shock or cardiac arrest. The exact complication rate is not well understood, in part because of small study sizes. In the absence of large clinical trials, performance of pooled analysis represents the best method for ascertaining complication rates for ECMO. METHODS A systematic PubMed search was conducted on ECMO for treatment of cardiogenic shock or cardiac arrest in adult patients only, updated to November 2012. Studies with more than 10 patients published in the year 2000 or later that reported complication rates for ECMO were included. Specific complications analyzed included lower extremity ischemia, fasciotomy or compartment syndrome, amputation, stroke, neurologic complications, acute kidney injury, renal replacement therapy, major or significant bleeding, rethoracotomy for bleeding or tamponade, and significant infection. For studies that included overlapping patients, the largest study was included and the others excluded. Cochrans Q and I-squared were calculated. A more conservative random-effects model was chosen for all analyses. RESULTS Twenty studies were included in the analyses encompassing 1,866 patients. Seventeen studies reported survival to hospital discharge, with a cumulative survival rate of 534 of 1,529, and a range of 20.8% to 65.4%. Analyses encompassed 192 to 1,452 patients depending on the specific complication analyzed. The pooled estimate rates of complications with 95% confidence intervals were as follows: lower extremity ischemia, 16.9% (12.5% to 22.6%); fasciotomy or compartment syndrome, 10.3% (7.3% to 14.5%); lower extremity amputation, 4.7% (2.3% to 9.3%); stroke, 5.9% (4.2% to 8.3%); neurologic complications, 13.3% (9.9% to 17.7%); acute kidney injury, 55.6% (35.5% to 74.0%); renal replacement therapy, 46.0% (36.7% to 55.5%); major or significant bleeding, 40.8% (26.8% to 56.6%); rethoracotomy for bleeding or tamponade in postcardiotomy patients, 41.9% (24.3% to 61.8%); and significant infection, 30.4% (19.5% to 44.0%). CONCLUSIONS Although ECMO can improve survival of patients with advanced heart disease, there is significant associated morbidity with performance of this intervention. These findings should be incorporated in the risk-benefit analysis when initiation of ECMO for cardiogenic shock is being considered.

Clinical Manifestations and Management of Left Ventricular Assist Device–Associated Infections

BACKGROUND Infection is a serious complication of left ventricular assist device (LVAD) therapy. Published data regarding LVAD-associated infections (LVADIs) are limited by single-center experiences and use of nonstandardized definitions. METHODS We retrospectively reviewed 247 patients who underwent continuous-flow LVAD implantation from January 2005 to December 2011 at Mayo Clinic campuses in Minnesota, Arizona, and Florida. LVADIs were defined using the International Society for Heart and Lung Transplantation criteria. RESULTS We identified 101 episodes of LVADI in 78 patients (32%) from this cohort. Mean age (± standard deviation [SD]) was 57±15 years. The majority (94%) underwent Heartmate II implantation, with 62% LVADs placed as destination therapy. The most common type of LVADIs were driveline infections (47%), followed by bloodstream infections (24% VAD related, and 22% non-VAD related). The most common causative pathogens included gram-positive cocci (45%), predominantly staphylococci, and nosocomial gram-negative bacilli (27%). Almost half (42%) of the patients were managed by chronic suppressive antimicrobial therapy. While 14% of the patients had intraoperative debridement, only 3 underwent complete LVAD removal. The average duration (±SD) of LVAD support was 1.5±1.0 years. At year 2 of follow-up, the cumulative incidence of all-cause mortality was estimated to be 43%. CONCLUSION Clinical manifestations of LVADI vary on the basis of the type of infection and the causative pathogen. Mortality remained high despite combined medical and surgical intervention and chronic suppressive antimicrobial therapy. Based on clinical experiences, a management algorithm for LVADI is proposed to assist in the decision-making process.

Ventricular assist devices today and tomorrow.

p 2 m HE NUMBER OF people worldwide with heart failure (HF) is increasing at an alarming pace. In the United States lone, there are approximately 5.3 million people who have HF, ith a prevalence estimated at 10 per 1,000 in people over the ge of 65.1 It is now estimated that there are 660,000 new cases f HF diagnosed every year for people over 45 years of age. In 008, there were more than 1 million hospital admissions for F at a cost of

Success rates of long-term circulatory assist devices used currently for bridge to heart transplantation.

34.8 billion. Currently, preventative measures, ptimal medical therapy, and heart transplantation are not efectively reducing the overall morbidity and mortality of this yndrome. The American College of Cardiology/American Heart Assoiation (ACC/AHA) have classified HF in 4 stages based on the rogression of the disease (Table 1).2,3 Early in the course of he disease (stages A and B), symptoms are absent or mild, but he patients are at high risk of developing symptomatic or efractory disease. As the disease progresses through stage C, entricular function is maintained by adrenergic stimulation, ctivation of renin-angiotensin-aldosterone, and other neurohuoral and cytokine systems.4,5 These compensatory mechaisms become less effective over time, and cardiac function eteriorates to the point where patients have marked symptoms t rest (stage D). The ACC/AHA-recommended therapeutic ptions for patients with stage D symptoms are continuous notropic support, heart transplantation, mechanical circulatory upport, or hospice care. Standard HF medical therapies such as angiotensin-convertng enzyme inhibitors, -blockers, diuretics, inotropic agents, nd antiarrhythmics may relieve symptoms, but the mortality ate remains unaffected. Optimal medical therapy does not halt he progression toward stage D HF symptoms, and when this ccurs, there is a greater than 75% 2-year mortality risk, with urgical intervention being the only effective treatment. Cariac transplantation is an effective therapy for terminal HF and s associated with excellent 1-year survival (93%), 5-year surival (88%), and functional capacity.6 However, there are aproximately 2,200 donors available for as many as 100,000 atients with advanced-stage HF.7 Moreover, donor hearts are sually reserved for patients 65 years of age even though lder patients have the highest prevalence of HF. Patients over 5 years of age and those with other comorbidities are often neligible for transplantation, creating a considerable need for lternative therapies. s

Implantation technique for the CardioWest total artificial heart

Circulatory assist devices as bridge to heart transplantation have become more important as the number of possible recipients has increased and the number of donors remains stable. The number of patients successfully bridged and discharged home after transplantation was determined for the Novacor Left Ventricular Assist System (Baxter Healthcare Corp., Oakland, CA) (LVAS), console and wearable; the TCI Left Ventricular Assist Device (Thermo Cardio Systems Inc., Woburn, MA) (LVAD), pneumatic and electric; the Thoratec LVAD and Biventricular Assist Device (Thoratec Lab Co., Berkeley, CA) (BIVAD); and the CardioWest total artificial heart (CardioWest Tech. Inc., Tuscon, AZ) (TAH). A total of 1,286 devices (14% Novacor console, 14% Novacor wearable, 35% TCI pneumatic, 4% TCI electric, 10% thoratec LVAD, 19% Thoratec BIVAD, and 4% CardioWest TAH) were implanted worldwide since 1984. A total of 776 (60%) patients reached heart transplantation and 687 patients (88.5% of those transplanted) were discharged home. The individual success rate for each device to bridge a patient to heart transplantation and be discharged home is as follows: Novacor LVAS console, 90%; Novacor LVAS wearable, 92%; TCI LVAD pneumatic, 89%; TCI LVAD electric, 89%; Thoratec LVAD, 93%; Thoratec BIVAD, 81%; and CardioWest TAH, 92%. The success rate with all the available systems to bridge a patient to heart transplantation and be discharged home is similar for all devices. The criteria used to determine which system to be used should be individualized for each patient. Some of the factors that should be considered in making a decision on which device to use should include anticoagulation, univentricular vs biventricular failure, mobility, protocol to discharge home, and size of the patient.

The CardioWest total artificial heart bridge to transplantation: 1993 to 1996 National Trial

The CardioWest total artificial heart is a pneumatically driven device that totally replaces the failing ventricles. It is currently undergoing clinical investigation as a bridge to heart transplantation in several centers throughout the world. A bilateral ventriculectomy is performed and the device is implanted. Blood flows are usually maintained at 6-8 L/min. Approximately 130 patients have undergone bridge to transplant with this device. Patient selection and excellent surgical technique are required for a successful outcome. A detailed description of the implantation technique is presented to facilitate the use of this technology.

Cardiovascular assist devices.

BACKGROUND We performed a controlled study of a total artificial heart in bridge to transplantation. We hypothesized that the CardioWest total artificial heart used in a selected population of decompensating cardiac transplantation candidates would result in improved survival compared with matched controls. METHODS The CardioWest trial started in 1993 in six United States institutions under an investigational device exemption from the Food and Drug Administration. Four centers contributed 27 implant and 18 matched retrospective control patients. RESULTS Of the implant patients, 25 (93%) received a transplant, 24 (89% of the total, 96% of those transplanted) were discharged and are currently surviving. In the control group, 10 patients died awaiting transplantation, 8 received a transplant, and 7 were discharged with 6 surviving (p = 0.00001). All adverse events were documented with respect to time. Thirteen serious adverse events occurred, 11 of which occurred in the 2 patients that died during implant. CONCLUSIONS In a selected group of patients with endstage heart disease, use of the CardioWest total artificial heart is lifesaving. When compared with the series of matched retrospective controls, a significant improvement in survival was found in the CardioWest implant group.

Natural history of left ventricular mechanics in transplanted hearts: relationships with clinical variables and genetic expression profiles of allograft rejection.

A cardiovascular assist device for producing an inwardly orienting pulsating pressure circumferentially to the entire length of each extremity of a patient, including a main body portion surrounding the extremity and a lateral body portion being inflatable to tightly constrict the main body portion about the extremity before pulsation. The lateral body portion includes a single inflatable tube having connecting tapes extending substantially entirely circumferentially therearound and oppositely circumferentially at least partially around said main body portion to terminal ends secured to the main body portion. The main body portion includes an outer restraint material reinforced by a plurality of circumferentially extending and a plurality of longitudinally extending restraint tapes, two sheets of resilient material circumferentially bonded together at longitudinal intervals and longitudinally along seams to produce a plurality of overlapping circumferentially extending inflatable bladders, which are longitudinally spaced from each other, an inner pouch material and a plurality of fluid couplings communicating with each bladder and inflatable tube. Mittens are provided to close one end of each main body portion and similarly constructed to provide an inwardly pulsating pressure to the respective hand or foot of the patient. The main body portions and mittens may be donned and doffed by means of respective longitudinally extending fasteners, and thereafter manually circumferentially constricted by means of longitudinally extending lacings prior to the pressure constriction caused by inflating the lateral body portion.

Arizona experience with CardioWest Total Artificial Heart bridge to transplantation.

OBJECTIVES The aim of this study was to explore the temporal evolution of left ventricular (LV) mechanics in relation to clinical variables and genetic expression profiles implicated in cardiac allograft function. BACKGROUND Considerable uncertainty exists regarding the range and determinants of variability in LV systolic performance in transplanted hearts (TXH). METHODS Fifty-one patients (mean age 53 ± 12 years; 37 men) underwent serial assessment of echocardiograms, cardiac catheterization, gene expression profiles, and endomyocardial biopsy data within 2 weeks and at 3, 6, 12, and 24 months after transplantation. Two-dimensional speckle-tracking data were compared between patients with TXH and 37 controls (including 12 post-coronary artery bypass patients). Post-transplantation mortality and hospitalizations were recorded with a median follow-up period of 944 days. RESULTS Global longitudinal strain (LS) and radial strain remained attenuated in patients with TXH at all time points (p < 0.001 and p = 0.005), independent of clinical rejection episodes. Failure to improve global LS at 3 months (≥ 1 SD) was associated with higher incidence of death and cardiac events (hazard ratio: 5.92; 95% confidence interval: 1.96 to 17.91; p = 0.049). Multivariate analysis revealed gene expression score as the only independent predictor of global LS (R(2) = 0.53, p = 0.005), with SEMA7A gene expression having the highest correlation with global LS (r = -0.84, p < 0.001). CONCLUSIONS Speckle tracking-derived LV strains are helpful in estimating the burden of LV dysfunction in patients with TXH that evolves independent of biopsy-detected cellular rejection. Failure to improve global LS at 3 months after transplantation is associated with a higher incidence of death and cardiac events. Serial changes in LV mechanics correlate with peripheral blood gene expression profiles and may affect the clinical assessment of long-term prognosis in patients with TXH.