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Objectives: The aim of this study was to determine the safety and efficacy of a novel pimecrolimus-eluting stent in a porcine coronary model and in a phase I clinical trial. Background: Rapamycin- and paclitaxel-eluting stents reduce the need for repeat intervention by limiting neointimal hyperplasia but might cause delayed healing, pre-disposing patients to late stent thrombosis. Because inflammation plays a key role in restenosis, pimecrolimus, an anti-inflammatory drug, might reduce restenosis without adversely affecting re-endothelialization. Methods: We evaluated a novel polymeric pimecrolimus-eluting stent covered with a thin parylene C diffusion barrier in a porcine coronary model and in a phase I human clinical trial. The clinical study was a prospective, nonrandomized, first-in-human hypothesis-generating study that enrolled 15 patients who had a single de novo native coronary stenosis. Results: At 28 days and 3 months in the porcine model, histopathologic indicators predicted safety and biocompatibility when stents coated with polymer only, drug only, and 2 drug-polymer formulations were compared with bare-metal stents (BMS). In the phase I clinical trial, 15 patients had successful implantation of pimecrolimus-eluting stents. By 6 months, no patient suffered death, myocardial infarction, or stent thrombosis. However, the angiographic restenosis (61%), mean late loss (1.44 mm), and repeat target lesion revascularization (53%) were significantly higher than historical BMS controls. Whereas the primary end point was percent volume obstruction, restenosis was so severe that operators performed intravascular ultrasound examination in only 6 patients. Conclusions: Pimecrolimus-eluting stents induced an exaggerated neointimal hyperplasia at 6 months in comparison with historical controls. [Copyright &y& Elsevier]

Objectives: This study provides insights into “crush” coronary bifurcation stenting through imaging of bench deployments. Background: Although the strategy of provisional side-branch stenting is widely accepted for suitable bifurcation lesions, there is no consensus on the best option for elective stenting with 2 stents. The crush technique has the potential to scaffold and apply the drug to the side-branch ostium where restenosis is most common. Methods: Sequential steps of crush stent deployment and post-dilation were undertaken in silicone phantoms and recorded on cine angiography and microcomputed tomography. We assessed the effect of deployment strategies, post-dilation strategies, and cell size on side-branch ostial area. Results: Side-branch ostial coverage by metal struts was 53% (95% confidence interval [CI]: 46 to 59) after 1-step kissing post-dilation and was reduced by 2-step kissing post-dilation to 33% (95% CI: 28 to 37; p < 0.0001). Although the residual stenosis after the classical crush strategy was 47% (95% CI: 39 to 53), it was 36% (95% CI: 31 to 40; p = 0.002) after mini-crush deployment. Stents with larger cell size (>3.5 mm diameter) had a residual stenosis of 37% (95% CI: 32 to 42) after crush deployment that was less than the residual stenosis for stents with smaller cell size (52%; 95% CI: 44 to 60; p < 0.0001). Conclusions: Side-branch ostial stenosis after crush stenting was minimized by mini-crush deployment, 2-step kissing post-dilation, and the use of stents with larger cell size. It is unknown if optimizing stent deployment at bifurcation lesions will reduce clinical stent thrombosis and restenosis. [Copyright &y& Elsevier]

Purpose: The purpose of this study is to describe the first experience of implanting a new left ventricular assist device in pediatric patients with end-stage heart failure. Description: In two recent prospective, international, multicenter clinical trials, three children (aged ≤ 16 years) were implanted successfully with the VentrAssist (Ventracor Limited, Chatswood, Australia), a relatively small, novel, continuous flow, third-generation left ventricular assist device. Evaluation: Despite the patients'' disease severity (each child was in extremis at the time of implantation), VentrAssist (Ventracor Limited) implantation enabled each patient to be discharged home from the hospital. All patients survived for more than 1 year. One patient was successfully transplanted and another was bridged to an adequate degree of recovery; unfortunately, the third patient died on postoperative day 375 while waiting for a suitable donor heart. Consistent with the complications associated with left ventricular assist devices in adults, the main complications in these pediatric patients were infection and thromboembolism. Conclusions: The VentrAssist may provide a major advancement in the management of larger children and adolescents with end-stage heart failure. [Copyright &y& Elsevier]

Background: The purpose of this study was to investigate whether broadening acceptance criteria for donor hearts and changing recipient demographics resulted in an increased perioperative morbidity and mortality in a heart transplant program.Methods: Donor and recipient data of 137 consecutive heart transplants performed from 1987 to 2001 were retrospectively analyzed and divided into three equal eras, each of 5 years: 1987 to 1991, 1992 to 1996, and 1997 to 2001. Multivariate analyses of recipient and donor demographics and operative factors were performed to identify the predictors of low cardiac output, intraaortic balloon pump utilization, 30-day mortality, and duration of intensive care and hospital stay.Results: Significant increases in number of female recipients (p = 0.025), cardiopulmonary bypass (p < 0.001), recipient cross-clamp (p < 0.001), donor age (p = 0.009), donor ischemic times (p < 0.001), use of cardioplegia (p < 0.001) and the bicaval technique (p < 0.001), brain death to retrieval time (p = 0.006), and need for postoperative dialysis were observed for the three study periods, whereas length of intensive care and hospital stay decreased. Female donor (odds ratio [OR], 2.4; 95% confidence interval [CI], 1.0 to 5.7) was identified as a risk factor for low cardiac output. Female donor (OR, 3.7; 95% CI, 1.3 to 10.7), donor cardiac arrest (OR, 6.4; 95% CI, 1.6 to 25.9), and cardiopulmonary bypass time more than 2 hours (OR, 7.6; 95% CI, 2.1 to 28.1) were associated with increased intraaortic balloon pump utilization. Intensive care stay was prolonged by the biatrial technique (OR, 3.9; 95% CI, 1.3 to 11.9) and reduced by the use of cardioplegia (OR, 0.3; 95% CI, 0.1 to 0.9), longer cardiopulmonary bypass (OR, 0.2; 95% CI, 0.1 to 0.6) and aortic cross-clamp times (OR, 0.1; 95% CI, 0.03 to 0.6).Conclusions: Although a number of significant changes were observed during the study period, no donor, recipient, or operative factors influenced 30-day mortality. This study justifies our current donor and recipient selection policies. [Copyright &y& Elsevier]

The article focuses on the study related to adverse cardiac events in diabetics undergoing percutaneous coronary intervention. Univariate and multivariate analyses, with 37 clinical and angiographic variables, compared those with and without restenosis. Predicted restenosis rates were calculated using reference charts derived from angiographic data. 418/3090 stented patients with 6 month angiographic follow up had diabetes. Restenosis occurred in 550/2672 non-diabetic and 130/418 diabetic patients. Univariate predictors of restenosis in those with diabetes were vessel reference diameter minimal luminal diameter before stenting, MID and percentage diameter stenosis after stenting, stented vessel length and reduced body mass index.

Cardiac allograft rejection is typically diagnosed on the basis of hematoxylin and eosin (H&E) histology of endomyocardial biopsies. This diagnosis is made based on the degree of immune cell infiltrate and associated myocyte damage. However, considerable variability in rejection grading between pathologists can occur. Confocal microscopy provides high contrast and high resolution imaging that has the potential to provide detailed views of pathological features of allograft rejection. In this pilot study we sought to determine if confocal microscopy could be used to detect features of cardiac rejection. This was achieved by collection of additional sample at 30 biopsy procedures from 15 heart transplant patients. Routine pathological grading of H&E histology identified 5 gradings of 0R, 21 gradings of 1R, and 3 gradings of 2R. From these gradings, 3 samples for 0R, 9 samples for 1R, and 3 samples for 2R were imaged by confocal microscopy. This was achieved by fluorescently labeling sections with DAPI, wheat germ agglutinin, and phalloidin, to visualize the cell nuclei, cell border and extracellular matrix, and muscle cell actin, respectively. Labeling with these fluorescent markers was of high contrast. However, we did note variability in DAPI and phalloidin labeling of tissue sections. Confocal imaging of these labels revealed the following features at high resolution: perivascular and/or interstitial infiltrate, myocyte damage, and Quilty lesions. In particular increased detail of damaged myocytes reveals distortion in myofilament organization that could be exploited to distinguish between 1R and 2R grades. In conclusion, confocal microscopy provided high contrast and resolution imaging of cardiac biopsies that could be explored further to aid assessment of cardiac allograft rejection., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Osteoporosis is prevalent among heart or lung transplant (HLT) candidates. Bone loss is common posttransplant, with an associated increase in fracture risk. There is a lack of consensus regarding optimal management of bone health in HLT recipients. We report bone health data in a cohort of HLT recipients before and after transplantation and make recommendations for management., Methods: Patients over the age of 20 who had a heart or lung transplant between 2000 and 2011 were identified from the New Zealand HLT Service database, and demographic data, immunosuppressive regimens, bisphosphonate use, and serial bone mineral density (BMD) data were extracted., Results: Pretransplant BMD was available in 52 heart and 72 lung transplant recipients; 30 and 42, respectively, also had posttransplant BMD data. Pretransplant osteopenia or osteoporosis prevalence were 23% and 8% for heart candidates and 36% and 31% for lung candidates. Posttransplant, BMD decreased significantly at the femoral neck but not at the lumbar spine in the first year, with subsequent stabilization particularly in the presence of bisphosphonate use. Pretransplant BMD was the major predictor for developing osteopenia or osteoporosis after transplantation., Conclusion: A significant proportion of HLT recipients have osteopenia or osteoporosis pretransplant, and this persists posttransplant. Pretransplant BMD is an important predictor of subsequent osteopenia or osteoporosis development, allowing risk stratification and targeted intervention., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Heart transplantation is an established treatment for end-stage cardiac disease. This study describes parenthood after heart transplantation in the New Zealand population. An analysis was performed of all heart recipients from the New Zealand program. Exclusion criteria were death within 3 months of transplantation or age <18 years at the time of the survey. Recipients (or next of kin if recipients deceased) were surveyed regarding family status at the time of transplantation and new parenthood after transplantation. A total of 145 of 199 eligible recipients completed the survey ∼12.2 years after transplant (119 male, 26 female). Before transplantation, 81% were in a permanent relationship; 72% had children. After transplantation, 19/45 recipients had 27 children (2 female recipients had 3 children), of whom 15 were planned. Complications occurred in 7/27 pregnancies (including one atrial septal defect requiring surgery). Two recipients died after the birth of their children (children aged 2.6 and 14.1 years). This study provides unique data relevant to both female and male recipients regarding new parenthood after heart transplantation and will promote more informed discussion with transplant recipients., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Introduction: Return to work and social re-integration following heart transplantation is a significant challenge for patients. The aim of this study is to provide a snapshot of the current employment status and factors associated with return to work in New Zealand recipients over the past decade., Methods: Consecutive surviving patients who underwent heart transplantation in the 10 years from June 2001 to June 2011, alive in July 2012, were retrospectively identified. Details on demographics, employment before and after transplantation were obtained and recorded., Results: A total of 87 patients were included, out of a total of 111 patients who underwent heart transplantation in the 10 year period from June 2001 (24 patients had died prior to July 2012). The median age of the study cohort was 52 years (range 15-75 years) and 19 were female. A total of 51 (58.6%) patients were in paid employment at the time of review. Of the 36 (41.4%) patients not in paid employment, 5 were students, 12 were retired and 10 were homemakers or not working through lifestyle choice. Two patients were unable to work for health reasons. Seven (8%) patients considered able to work were on an unemployment or invalid's benefit. Of the patients working prior to heart transplantation, 88.9% returned to work after a median of 8.5 months, and 70.6% remained on paid employment at a median follow-up of 77 months after transplantation. There was a statistically significant correlation between the time of stopping work prior to transplant and return to work after transplant (r = 0.497, P < .01)., Conclusion: The current rate of paid employment in patients who underwent heart transplantation was similar to the overall employment rate in New Zealand. The most important predictor of returning to work was employment status prior to transplantation. Discussions regarding return to work early in the transplantation assessment process and actively assisting patients to seek employment after transplantation may improve employment rates., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: For patients with an atrial septal defect and pulmonary hypertension it can be difficult to determine whether it is safe to intervene. With newer treatments for pulmonary hypertension and transcatheter techniques avoiding surgical stressors, it has been hoped that we can occlude previously inoperable defects safely., Methods: We undertook a subgroup analysis of outcomes for patients with mean pulmonary artery pressure (PAp) ≥30mmHg from within our database of patients undergoing transcatheter ASD closure from 1997 to 2004., Results: Data for 11 patients were reviewed. Mean age of the patients at intervention was 38 years (5-69 years). Eight patients have had symptomatic improvement with no evidence of progressive pulmonary hypertension. There was one death due to unrelated causes. Two patients have developed progressive pulmonary vascular disease with one death., Conclusions: Despite early symptomatic improvement, adverse outcomes may occur in patients with elevated pulmonary vascular resistance undergoing transcatheter ASD closure. Careful haemodynamic evaluation is vital. Modest elevation of pulmonary vascular resistance and the presence of left to right shunt (Qp:Qs>1.5:1) are reassuring., (Copyright © 2010 Australasian Society of Cardiac and Thoracic Surgeons and the Cardiac Society of Australia and New Zealand. Published by Elsevier B.V. All rights reserved.)

Background: Many thoracic transplant recipients who receive organs from the same donor share facilities for 3 months, and are aware that they have received organs from the same donor., Methods: A confidential questionnaire including open and closed questions assessed relationships between "twins" and the experience of having a twin. The Significant Others Scale assessed social support. Of 141 heart and 58 lung transplants, 25 pairs of transplant twins were identified. Questionnaires were sent to the 32 surviving twins., Results: Twenty-six twins responded; 17 had received a heart and nine a lung. The 17 men and 9 women had a mean age of 51 years. Eighteen respondent's "twins" remained alive at the time of participation and eight had died. Sixty-six percent of the both- twin alive group and 43% of one-twin alive group felt they had a special bond with their twin, different from the other relationships that they have experienced. Fifty-six percent of the both-twin alive group and 43% of one-twin alive group felt having a twin enriched their transplant experience. Transplant twins rated social support last behind: the transplant support personnel; close family members; other transplant recipients; and good friends and general practitioners, both in levels of ideal and actual support. Transplant twins showed the largest discrepancy between levels of ideal and actual support than any other individual ranked., Conclusions: Being a transplant twin is a special experience that generally enriches the overall transplant experience but having a transplant twin, does not appear to enhance the amount of social support., (Copyright 2004 Elsevier Inc.)