Gonzalo V. Gonzalez-Stawinski

Effectiveness and Safety of the Impella 5.0 as a Bridge to Cardiac Transplantation or Durable Left Ventricular Assist Device

Many patients with end-stage heart failure require mechanical circulatory support as a temporizing measure to enable multidisciplinary assessment for the most suitable therapeutic strategy. Impella 5.0 can be used as a bridge to decision to evaluate patients for potential recovery or bridge to next therapy (bridge to heart transplantation [BTHT] or bridge to durable left ventricular assist device or VAD [BLVAD]. Our goal was to examine single-center outcomes with the Impella 5.0 device as a bridge to next therapy (BTHT or BTLVAD). Forty patients underwent Impella 5.0 support from December 2009 to December 2015 with the intent of BTHT (nxa0= 20) or BTLVAD (nxa0= 20). The primary end point was survival to next therapy. Secondary end points included hemodynamic assessments and in-hospital/30-day complications. All patients were inotrope-dependent, with severely depressed left ventricular ejection fraction (12%) and renal insufficiency (creatinine 2.0xa0mg/dl). Most were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) 2 (66%) with biventricular failure (65%). Thirty patients (75%) survived to next therapy, including transplant (nxa0= 13), durable LVAD (nxa0= 15), and recovery of native heart function (nxa0= 2). No strokes or major bleeding events requiring surgery were observed. Acute renal dysfunction, bleeding requiring transfusion, hemolysis, device malfunction, limb ischemia occurred in 13 (33%), 11 (28%), 3 (8%), 4 (10%), and 1 (3%) patients, respectively. Survival rate to discharge and/or 30xa0days was 68% (27 of 40). Temporary support with the Impella 5.0 allows for an effective bridge to decision strategy for hemodynamic stabilization and multidisciplinary heart team assessment of critically ill patients with heart failure. In conclusion, many of thesexa0patients can be subsequently bridged to the next therapy with favorable outcomes.

HLA and MICA allosensitization patterns among patients supported by ventricular assist devices

BACKGROUNDnVentricular assist devices (VADs) are increasingly being used as a bridge to transplantation and have been implicated as a risk factor for allosensitization to human leukocyte antigens (HLA). We investigate the association between VAD and allosensitization to human leukocyte antigens (HLA) and major-histocompatibility-complex (MHC) class I-related Chain A (MICA) antigens.nnnMETHODSnWe considered all patients who received a VAD at our institution between 2000 and 2009; 89 of them had pre-VAD and post-VAD (≤6 months after implant) HLA antibody screening. A control group of non-VAD heart transplant candidates was constructed with at least 2 pre-transplant panel-reactive antibody (PRA) tests within 8 months. Two controls were randomly selected/VAD patient matched for year (n = 178). Patients and controls with available sera from these time-points were tested by Luminex/flow PRA single-antigen beads and by MICA antibody Luminex single-antigen beads. Medical records were reviewed for comparison of pre-transplant immunologic risk factors and post-transplant outcomes between the 2 groups.nnnRESULTSnCompared with controls, VAD patients had greater Class I differences between peak and initial PRA (18% vs. 0%, p < 0.0001) and higher peak PRA (24% vs. 6%, p < 0.0001). The differences between the 2 groups in Class II were less pronounced than in Class I. Of patients who had single-antigen testing, VAD implantation was significantly associated with development of new HLA antibody specificities (Class I and/or Class II) post-VAD with an increase in calculated PRA (cPRA) post-VAD compared with controls (16% vs. 0%, p < 0.0001). This risk was still present after adjusting for age, gender, pre-VAD PRA, transfusion and duration of follow-up in a multivariate analysis (p < 0.0001 and 0.02, respectively). There were no differences in development of MICA antibodies between the 2 groups (14% in both). There was no significant difference in the incidence of pre-transplant positive T-cell crossmatch, pre-transplant donor-specific HLA antibodies, rejection episodes or graft survival between the 2 groups.nnnCONCLUSIONnOur results suggest that VAD is associated with significant HLA allosensitization independent of common risk factors.

Pulsatile vs. continuous flow in ventricular assist device therapy

A left ventricular assist device (LVAD) is an important treatment option for a patient with end-stage heart failure. Both continuous and non-pulsatile devices are available, each with different effects on a patients physiology. In general, these effects are not clinically significant with the exception of bleeding events which are more common with continuous-flow devices in some series. Both devices increase survival beyond medical management. Continuous-flow devices are smaller and are associated with less overall morbidity than pulsatile devices.

Ventricular assist devices: The future is now

Heart failure has become a global epidemic. For advanced heart failure, a broad assortment of device options have been introduced for both acute and prolonged intervals of hemodynamic assistance. Durable implantable ventricular assist devices (VADs) in particular play a key role in the management of advanced heart failure. This review focuses specifically on the current outcomes with VAD therapy, highlights the results from pivotal clinical trials, and summarizes the various device options on the market and those in preclinical development.

Application of the International Society for Heart and Lung Transplantation (ISHLT) criteria for primary graft dysfunction after cardiac transplantation: outcomes from a high-volume centre

OBJECTIVESnA standardized definition for primary graft dysfunction (PGD) after cardiac transplantation was recently proposed by the International Society of Heart and Lung Transplantation (ISHLT). We sought to characterize the outcomes associated with and identify risk factors for PGD following cardiac transplantation using these criteria at a high volume centre.nnnMETHODSnDonor and recipient medical records of 201 consecutive adult cardiac transplantations performed between November 2012 and March 2015 were retrospectively reviewed. Patients undergoing isolated heart transplantation were diagnosed with none, mild, moderate, or severe PGD using ISHLT criteria. Cumulative survival was calculated according to the Kaplan–Meier method. Associations of risk factors for combined moderate/severe PGD were assessed with univariate and multivariate analyses.nnnRESULTSnA total of 191 consecutive patients underwent isolated heart transplantation, and 59 (30%) met ISHLT criteria for PGD: 35 (18%) mild, 8 (4%) moderate and 16 (8%) severe. Thirty-day/in-hospital mortality occurred in six (3%) patients, all of whom were diagnosed with severe PGD. Patients with moderate/severe PGD also had significantly increased intensive care unit length of stay (LOS), total LOS, reoperations for bleeding and postoperative infections. Survival at 1-year was diminished with increasing severity of PGD (none 93%, mild 94%, moderate 75% and severe 44%; log-rank Pu2009<u20090.001). Elevated preoperative creatinine, pretransplantation hospitalized recipient and undersized donor were independently predictive of moderate/severe PGD.nnnCONCLUSIONSnA diagnosis of PGD portends worse outcomes including increased 30-day and 1-year mortality. The ISHLT diagnostic criteria for moderate and severe PGD identify and discriminate patients with PGD in a clinically relevant manner.

Case series using the rotaflow system as a temporary right ventricular assist device after heartmate II implantation

The purpose of this study was to investigate the outcomes of using the ROTAFLOW as a temporary right ventricular assist device (RVAD) support in patients who develop right ventricular dysfunction (RVD) at the time of left ventricular assist device (LVAD) implantation with the HeartMate (HM) II. We conducted a retrospective chart review of patients in whom the ROTAFLOW system was used for RV support during HM II implantation from October 2009 to September 2011. Twelve patients received a ROTAFLOW as an RVAD at the time of HM II implantation; 83% had preoperative echocardiography evidence of either moderate or severe RVD. The most common complications in the postoperative period were the need for tracheostomy because of respiratory failure (45%) and mediastinal bleeding requiring exploration (36%). Ninety-one percent of patients survived to discharge, and all were alive at 1 year follow-up. Our results show that temporary RVAD support with the ROTAFLOW system in the setting of RVD at the time of HM II implantation is feasible and effective.

Utility of cardiac computed tomography for inflow cannula patency assessment and prediction of clinical outcome in patients with the HeartMate II left ventricular assist device

OBJECTIVESnProper inflow cannula orientation during implantation of the HeartMate II (HMII) left ventricular assist device (LVAD) is important for optimal pump function. This article describes our experience with cardiac computed tomography (CCT) to evaluate inflow cannula patency and predict future adverse outcomes (AE) after HMII LVAD implantation.nnnMETHODSnNinety-three patients underwent HMII LVAD implantation for end-stage cardiomyopathy from January 2010 until March 2014. A total of 25 consecutive patients had CCT after the implantation; 3 patients were excluded from the analysis due to associated abnormality of the outflow graft. The 22 patients with CCT after HMII LVAD were censored for adverse events related to LVAD malfunction after HMII LVAD implantation. The maximum percentage of inflow cannula obstruction on CCT was recorded. We analysed the predictive value of CCT in addition to other clinical and diagnostic variables for future AEs.nnnRESULTSnSeven of the 22 patients (32%) experienced AEs after HMII LVAD implantation. The degree of inflow cannula obstruction was higher in the group of patients who experienced an AE (70 vs 14%; P < 0.001). Inflow cannula obstruction >30% showed excellent correlation with AE longitudinally based on receiver operating curve (0.829). The group with AEs more frequently experienced CHF symptoms (P = 0.054).nnnCONCLUSIONSnInflow cannula obstruction >30% on CCT predicts future adverse events in patients with HMII LVAD; the need for surgical intervention in terms of LVAD exchange or urgent listing for heart transplantation should be considered in good surgical risk patients. Cardiac computed tomography should be considered routinely postoperatively in patients with HMII LVAD.

Anomalous cord from the raphe of a congenitally bicuspid aortic valve to the aortic wall producing either acute or chronic aortic regurgitation.

OBJECTIVESnThis report calls attention to an unappreciated cause of both acute and chronic aortic regurgitation (AR).nnnBACKGROUNDnAlthough stenosis develops in most patients with a congenitally bicuspid aortic valve (BAV), in others with this anomaly, pure AR (no element of stenosis) develops, some in the absence of infection or other clear etiology.nnnMETHODSnWe describe 5 men who underwent aortic valve replacement for pure AR associated with a BAV containing an anomalous cord attaching the raphe of the conjoined cusp near its free margin to the wall of the ascending aorta cephalad to the sinotubular junction.nnnRESULTSnThree of these 5 patients had a history of progressive dyspnea, and the anomalous cord, which was intact at operation, appeared to cause chronic AR by preventing proper coaptation of the 2 aortic valve cusps. The other 2 patients heard a pop during physical exertion and immediately became dyspneic, and at operation, the anomalous cord was found to have ruptured. Prolapse of the conjoined aortic valve cusp toward the left ventricular cavity resulted in severe acute AR.nnnCONCLUSIONSnThis variant of the purely regurgitant BAV may cause either chronic AR (when the anomalous cord does not rupture) or acute severe AR (when the cord ruptures).

Impact of donor age on cardiac transplantation outcomes and on cardiac function

OBJECTIVESnAlthough the impact of older donors on heart transplant outcomes has been previously published, the survival results are conflicting. We herein analyse the impact of older donors on transplant survival and myocardial function.nnnMETHODSnThe records of the patients who underwent heart transplant at Baylor University Medical Center at Dallas from November 2012 until March 2015 were reviewed and the data were extracted. The heart recipients were divided into two groups based on donors age; 50 years of age was the division point. The two groups were compared with regard to the following transplant outcomes: in-hospital and 1-year survival, severe (3R) rejection, primary graft dysfunction, myocardial performance as reflected by the inotropic score, left ventricular ejection fraction, intensive care unit and overall length of stay.nnnRESULTSnAnoxia was more common cause of death in younger donors (43.9%), whereas intracranial bleeding was more frequent in older donors (48.1%, P = 0.016). The in-hospital survival and 1-year survival were the same between the two groups. Additionally, cardiac transplantation from older donors was not associated with higher incidence of graft dysfunction, higher inotropic support score, longer intensive care unit and total hospital length of stay or more frequent severe rejection episodes. The left ventricular ejection fraction was similar between the two groups.nnnCONCLUSIONSnHeart transplant from older donors is not associated with lower in-hospital and mid-term survival if donors are carefully selected; furthermore, the graft function is comparable. The use of hearts from donors older than 50 years of age can be expanded beyond critically ill recipients in carefully selected recipients.

Major Adverse Renal and Cardiac Events After Coronary Angiography and Cardiac Surgery

BACKGROUNDnPatients at high risk for having postprocedural complications may receive iodixanol, an iso-osmolar contrast, during coronary angiography to minimize the risk of renal toxicity. For those who also require cardiac surgery, the wait time between angiography and surgery may be a modifiable factor capable of mitigating poor surgical outcomes; however, there have been inconsistent reports regarding the optimal wait time. We sought to determine the effects of wait time between angiography and cardiac surgery, as well as contrast-induced acute kidney injury on the development of major adverse renal and cardiac events (MARCE).nnnMETHODSnWe merged datasets to identify adults who underwent coronary angiography with iodixanol and subsequent cardiac surgery.nnnRESULTSnOf 965 patients, 126 (13.1%) had contrast-induced acute kidney injury; 133 (13.8%) had MARCE within 30 days and 253 (26.2%) within 1 year of surgery. After adjusting for contrast-induced acute kidney injury, age, and Thakar acute renal failure score, the effect of wait time lost significance for the full cohort, but remained for the subgroup of 654 who had coronary artery bypass graft surgery. Patients undergoing coronary artery bypass graft surgery within 1 day of coronary angiography had an approximate twofold increase in risk of MARCE (30-day hazard ratio 2.13, 95% confidence interval: 1.16 to 3.88, pxa0= 0.014; 1-year hazard ratio 2.07, 95% confidence interval: 1.32 to 3.23, pxa0= 0.002) compared with patients who waited 5 or more days.nnnCONCLUSIONSnPatients who had contrast-induced acute kidney injury and had cardiac surgery within 1 day of angiography had an increased risk of MARCE.