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Background: Transcatheter aortic valve implantation (TAVI) is considered for severe aortic valve disease at high and now intermediate risk for surgical aortic valve replacement. Risk stratification plays a critical role decision-making for intervention and modality. We compared the prognostic utility of surgical risk scores for TAVI in this meta-analysis., Methods: MEDLINE, Embase, Cochrane and Web of Science databases from 1 January 1980 to 31 December 2015 were searched. Studies were systematically reviewed for inclusion, and data extracted for pooled analyses., Results: Amongst 1688 articles searched, 47 full-text articles were screened and 24 studies (12,346 TAVI cases) included for analyses. Pooled c-statistics (95% confidence interval) for operative mortality were EuroSCORE 0.62 (0.57-0.67), EuroSCORE II 0.62 (0.59-0.66), STS Score 0.62 (0.59-0.65). Pooled calibration odds ratios (95%CI) were EuroSCORE 0.31 (0.25-0.38), EuroSCORE II 1.26 (1.06-1.51), STS 0.95 (0.72-1.27). C-statistics (95%CI) for 1-year mortality were EuroSCORE 0.62 (0.57-0.67), EuroSCORE II 0.66 (0.61-0.71) and STS Score 0.58 (0.53-0.64)., Conclusion: Surgical risk scores at most modestly discriminated operative and 1-year mortality. The EuroSCORE grossly over-estimated operative mortality while the EuroSCORE II and STS Scores fitted better to TAVI outcomes with their own limitations. There is a need for the development and validation of TAVI-specific risk models., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: Some patients continue to have significant heart failure symptoms despite optimal medical therapy., Methods: We describe a first-in-human experience with an implantable non-blood-contacting extra-ascending aortic counterpulsation heart assist system (C-Pulse) in 5 end-stage heart failure patients, aged 54 to 73 years., Results: All patients improved by 1 NYHA class and improvements in invasive hemodynamics were documented in 3 patients. Three of 5 patients (60%) had infectious complications. Two patients were explanted at 5 and 7 weeks, respectively, as a result of mediastinal infection related to the implant procedure. One patient was successfully transplanted at 1 month and 1 remained hemodynamically improved on the device at 6 months but suffered infective complications. The device and protocol have been modified as a result of this pilot study with a further multicenter safety study underway., Conclusions: Although feasibility of this device is suggested by this pilot study, safety and efficacy will need to be examined in a larger cohort with longer follow-up., (Copyright © 2010 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

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.

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

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.

The risk of Kaposi's sarcoma (KS) is increased after organ transplantation. Management of KS in the cardiac transplant population may be difficult because reduction of immunosuppression is often not practical. This report describes a case of KS occurring in the early post-transplant period. Modification of immunosuppression with the use of sirolimus led to tumor regression for 24 months, but with subsequent localized progression of disease.

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.

We report the case of a 32-year-old heart transplant recipient who suffered several episodes of early Grade IIIA rejection and, on serial coronary angiography, demonstrated aggressive allograft vasculopathy. Severe lesions in the right coronary and left obtuse marginal arteries were stented; however, the disease was progressive and, almost 6 years after heart transplantation, she was retransplanted, providing us with the opportunity to examine the histology of transplant in-stent restenosis. She remains well 1 year after a second heart transplant operation.

We describe a 33-year-old heart transplant recipient who experienced several episodes of early Grade IIIA rejection and aggressive allograft vasculopathy, seen with serial coronary angiography. Two years after transplantation, we added sirolimus therapy to the patient's immunosuppressive regimen, and a further coronary angiogram 1 year later showed regression of the graft vasculopathy.