A. Kaan

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

KETOCONAZOLE TO REDUCE THE NEED FOR CYCLOSPORINE AFTER CARDIAC TRANSPLANTATION

BACKGROUND Because ketoconazole can markedly reduce the need for cyclosporine and because it also has antimicrobial properties, it may offer benefits in the treatment of patients after cardiac transplantation. METHODS We randomly assigned 43 patients at the time of cardiac transplantation to receive ketoconazole (200 mg per day) (23 patients) or no ketoconazole (20 patients). The main end points were the dose of cyclosporine required and the incidence of cardiac rejection and infection. RESULTS Ketoconazole reduced the dose of cyclosporine needed to maintain target levels by 62 percent at one week and by 80 percent at one year. The cost savings per patient (in U.S. dollars, inclusive of the cost of ketoconazole) was about

A systematic review of telemonitoring technologies in heart failure.

5,200 in the first year and about

Efficacy and safety of pravastatin vs simvastatin after cardiac transplantation

3,920 in each subsequent year. The mean (+/- SD) rate of rejection in the first month was lower in the ketoconazole group than in the controls (4.2 +/- 0.8 vs 5.7 +/- 1.0 episodes per 100 patient-days, P < 0.001), and the average number of days to the first rejection was higher (30 +/- 29 vs. 15 +/- 8, P = 0.03). In the first year, 22 percent of the ketoconazole group required cytolytic therapy, as compared with 35 percent of the controls, and 9 percent of the ketoconazole group required total lymphoid irradiation, as compared with 15 percent of the controls (P = 0.07). The incidence of infection was lower in ketoconazole-treated patients than in controls in the second month (1.4 +/- 0.5 vs. 2.8 +/- 0.7 episodes per 100 patient-days, P < 0.001) and in the third month (0.8 +/- 0.3 vs. 2.3 +/- 0.6 episodes per 100 patient days, P < 0.001). Transient, asymptomatic cholestasis was observed in the ketoconazole group. CONCLUSIONS After cardiac transplantation, ketoconazole greatly reduced the need for cyclosporine, resulting in substantial cost savings. Ketoconazole also reduced the rates of rejection and infection, without persistent toxic effects. We now use ketoconazole routinely in cardiac-transplant recipients.

Improvement in quality of life outcomes 2 weeks after left ventricular assist device implantation.

Heart failure (HF) results in characteristic signs and symptoms including oedema and breathing difficulties. Heart failure is particularly suited to telemonitoring, because patients’ signs and symptoms can be assessed remotely by healthcare providers, and deterioration can be quickly detected and addressed. In this paper, we review studies conducted in HF telemonitoring, to describe the nature of the modality, the methods, and the results.

Comparative outcomes in cardiogenic shock patients managed with Impella microaxial pump or extracorporeal life support.

Prior studies of cardiac transplant recipients have shown that pravastatin reduces 12-month rejection and mortality after cardiac transplantation and simvastatin reduces 4-year mortality, low-density lipoprotein (LDL) cholesterol levels, and intimal thickening. In a 12-month observational study, cardiac transplant recipients received open-label pravastatin 40 mg (n = 42) or simvastatin 20 mg daily (n = 45) on an alternating basis from the time of transplantation. Lipid levels, safety, and post-transplant outcomes were compared. We found no significant differences in total LDL or high-density lipoprotein cholesterol, triglycerides, linearized infection or rejection rates, liver function tests, or immunosuppressant dosages between groups at 1, 3, 6, or 12 months. Rhabdomyolysis or myositis occurred only in patients on simvastatin (n = 6, 13.3%) with no episodes for patients on pravastatin (p = 0. 032). Survival at 12 months on an actual treatment basis was 97.6% for patients on pravastatin and 83.7% for those on simvastatin (p = 0.078). Immunosuppression-related deaths occurred in only 2.4% (1 patient) on pravastatin vs 15.6% (n = 7) on simvastatin (p = 0.06). Pravastatin and simvastatin resulted in comparable lipid profiles. Pravastatin use was however free from the high rates of rhabdomyolysis and myositis seen with simvastatin use. Pravastatin was additionally associated with a trend toward superior survival, attributable to fewer immunosuppression-related deaths. For safety and pharmacokinetic reasons, pravastatin should be considered the statin of choice after heart transplantation.

Change in quality of life from after left ventricular assist device implantation to after heart transplantation

BACKGROUND The successful use of left ventricular assist devices (LVADs) as a bridge to heart transplantation has prompted our examination of quality of life (QOL) outcomes. The purposes of this study are to describe QOL in patients 1 to 2 weeks after LVAD implantation and to compare QOL in a smaller cohort of patients from before to 1 to 2 weeks after surgery. METHODS Data were collected from a convenience sample of 81 patients who completed booklets of questionnaires that measure domains of QOL 1 to 2 weeks after LVAD insertion and from 30 of 81 patients who completed booklets at both the pre-implantation and post-implantation periods. Patients completed booklets of 6 to 8 self-reporting instruments, with acceptable reliability and validity. Data were analyzed using descriptive and comparative statistics (chi-square, Mann-Whitney U and Wilcoxon signed ranks tests) with p = 0.01 considered statistically significant. RESULTS One to 2 weeks after LVAD implantation, patients were quite satisfied with their lives, experienced moderately low amounts of stress, coped well, and perceived themselves as having good health and QOL, low symptom distress, and moderately low functional disability. Patients reported significantly better QOL, more satisfaction with health and functioning, and were significantly less distressed by symptoms from immediately pre-operatively to post-operatively. However, patients reported significantly more self-care disability and more dissatisfaction with socioeconomic areas of life from before to immediately after surgery. Psychological distress was low and did not change with time. CONCLUSION Given that QOL improved from before to after LVAD implantation, our findings provide a springboard for investigation of the impact of LVADs on long-term QOL outcomes.

Off-Pump Implantation of the HeartWare HVAD Left Ventricular Assist Device Through Minimally Invasive Incisions

OBJECTIVE Cardiogenic shock is associated with poor clinical outcomes. Extracorporeal life support is used in most centers for short-term circulatory support. Alternatively, the Impella LP 5.0 and right direct (RD) microaxial ventricular assist device (Abiomed, Danvers, Mass) can provide isolated left and right ventricular support, respectively. METHODS A retrospective, single center review was performed on all patients receiving circulatory assistance with either extracorporeal life support or Impella ventricular assist device. All Impella LP 5.0 were inserted via the femoral artery, while the RD system required sternotomy. RESULTS Twenty-nine patients received ventricular assist device support (Impella LP 5.0; n = 24; and Impella RD; n = 5), whereas 32 patients were placed on extracorporeal life support. The baseline characteristics of patients with cardiogenic shock, assisted by Impella or extracorporeal life support, were similar, but the etiology of cardiogenic shock was distributed differently in the 2 groups (P = .008). Forty-one percent of the Impella patients and 47% of the extracorporeal life support patients were weaned from support. The 30-day mortality (44% in the extracorporeal life support vs 38% in the Impella group) and proportion of patients discharged home (41% in the extracorporeal life support vs 59% in the Impella group) were not statistically different between the 2 groups. Arterial thrombosis was less frequent in the Impella group (3.4% vs 18.8%; P = .04). Blood product transfusions were less frequent in the Impella group (P < .001). CONCLUSIONS Both extracorporeal life support and axial flow pumps provided adequate support in patients with various etiologies of cardiogenic shock. Axial-flow pump may be an optimal type of support for patients with univentricular failure, whereas extracorporeal life support could be reserved for patients with biventricular failure or combined respiratory and circulatory failure.

Successful Weaning and Explantation of the Heartmate II Left Ventricular Assist Device

BACKGROUND No studies have analyzed quality of life (QOL) from before to after heart transplantation in patients with a left ventricular assist device (LVAD). Therefore, the purpose of this longitudinal, multi-site study was to compare QOL outcomes of patients listed for heart transplantation who required a left ventricular assist device (LVAD) at 3 months after implantation of an LVAD vs 3 months after heart transplantation. METHODS A non-random sample of 40 patients (predominantly middle-aged, married, white men), who had paired data at both 3 months after LVAD implantation and 3 months after heart transplantation, were investigated. Patients completed self-report questionnaires (with acceptable reliability and validity) at both time periods, including the Quality of Life Index, Rating Question Form, Heart Failure Symptom Checklist, Sickness Impact Profile, LVAD Stressor Scale (completed only after LVAD implant), Heart Transplant Stressor Scale (completed only after heart transplant) and Jalowiec Coping Scale. Descriptive analyses and comparative analyses using paired t-tests were performed with statistical significance set at 0.01. RESULTS Patients were significantly more satisfied with their lives overall and with their health and functioning at 3 months after heart transplantation as compared with 3 months after LVAD implantation. Mobility, self-care ability, physical ability and overall functional ability improved from 3 months after LVAD implant to 3 months after heart transplant. There was significantly less symptom distress after LVAD implant as compared with after heart transplant for the neurologic, dermatologic and physical sub-scales. Work/school/financial stress was significantly lower after heart transplant vs after LVAD implant. In contrast, 2 other areas of stress were significantly lower after LVAD implant vs after heart transplant: self-care stress and hospital/clinic-related stress. CONCLUSIONS Differences were found in QOL outcomes at 3 months after LVAD implant as compared with 3 months after heart transplant. Our findings point out specific areas of concern with respect to QOL after LVAD implant and post-transplant, some of which are amenable to health-care provider interventions.

Brief screen to identify 5 of the most common forms of psychosocial distress in cardiac patients: validation of the screening tool for psychological distress.

Implantation of left ventricular assist devices through small incisions, avoiding cardiopulmonary bypass, may decrease the activation of the inflammatory and coagulation cascades and decrease bleeding and vasoplegia. One patient with severe, inotrope-dependant cardiomyopathy received the HeartWare left ventricular assist device (HeartWare Inc, Framingham, MA) through an upper ministernotomy and left minithoracotomy. The outflow graft was connected to the ascending aorta, and the inflow of the left ventricular assist device was attached through to the apex of the heart. The apical puncture was performed under rapid ventricular pacing, followed by insertion of the inflow of the pump. The patient was extubated rapidly and discharged home 14 days later.