Objectives The purpose of this study was to define anterior mitral leaflet (AML) length and mitral ring characteristics associated with LVOT obstruction and PVL following MViR. Background Transcatheter Mitral Valve in Ring (MViR) procedural complications including parvalvular leak (PVL) and left ventricular outflow tract (LVOT) obstruction are frequent. Methods Clinical records, computer tomographic scans (CTs) and echocardiograms of consecutive MViR patients were retrospectively reviewed for anterior mitral leaflet length, CT-simulated neoLVOT, and aortomitral angle among patients with and without MViR-induced LVOT obstruction. Acute and 1-year outcomes are described. Results Twenty-two patients underwent MViR. Technical success was achieved in 13/22 (57.1%) patients, limited by paravalvular regurgitation requiring second transcatheter heart valves (THVs) in seven patients. Second valves were needed in 6/11 (54.5%) patients with 3-dimensional rings but 1/11 (9.1%,p= .06) of patients with planar rings. Procedure success at 30 days was achieved in 20/22 (90.9%) patients. There were no procedural, in-hospital, or 30-day deaths. Two patients developed significant LVOT obstruction, one managed with urgent surgery and one with elective alcohol septal ablation. Anterior mitral leaflets were longer among the two patients with LVOT obstruction than the 20 patients who did not develop LVOT obstruction when measured by TEE (30 mm vs. 21 mm,p= .009) or by CT (29 mm vs. 22 mm,p= .026). Conclusions AML >25 mm increases the risk of MViR induced LVOT obstruction. PVL is common, particularly in 3-dimensional rings which can be managed with a second THV.

OBJECTIVES The purpose of this study was to evaluate the safety and efficacy of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) for stentless bioprosthetic aortic valves (SBAVs) and to identify predictors of adverse events. BACKGROUND ViV TAVR in SBAVs is associated with unique technical challenges and risks. METHODS Clinical records and computer tomographic scans were retrospectively reviewed for procedural complications, predictors of coronary obstruction, mortality, and echocardiographic results. RESULTS Among 66 SBAV patients undergoing ViV TAVR, mortality was 2 of 66 patients (3.0%) at 30 days and 5 of 52 patients (9.6%) at 1 year. At 1 year, left ventricular end-systolic dimension was decreased versus baseline (median [interquartile range (IQR)]: 3.0 [2.6 to 3.6] cm vs. 3.7 [3.2 to 4.4] cm; p < 0.001). Coronary occlusion in 6 of 66 procedures (9.1%) resulted in myocardial infarction in 2 of 66 procedures (3.0%). Predictors of coronary occlusion included subcoronary implant technique compared with full root replacement (6 of 31, 19.4% vs. 0 of 28, 0%; p = 0.01), short simulated radial valve-to-coronary distance (median [IQR]: 3.4 [0.0 to 4.6] mm vs. 4.6 [3.2 to 6.2] mm; p = 0.016), and low coronary height (7.8 [5.8 to 10.0] mm vs. 11.6 [8.7 to 13.9] mm; p = 0.003). Coronary arteries originated < 10 mm above the valve leaflets in 34 of 97 unobstructed coronary arteries (35.1%). CONCLUSIONS TAVR in SBAVs is frequently associated with high-risk coronary anatomy but can be performed with a low risk of death and myocardial infarction, resulting in favorable ventricular remodeling. A subcoronary surgical approach is associated with an increased risk of coronary obstruction. (C) 2019 by the American College of Cardiology Foundation.

Background: Driveline exit site (DLES) infection is a major complication of ventricular assist devices (VADs). Differences in the sheath material interfacing with exit site tissue appear to affect healing time and infection risk more than site hygiene, but the mechanistic basis for this is not clear.Methods: Health record data from Utah Artificial Heart Program patients with HeartMate II (HMII) devices implanted from 2008 to 2012 were retrospectively reviewed, with particular attention to interface type, incorporation (healing) time, and infections. Tissue samples from the DLES were collected at the time of VAD removal in a small subset. These samples were examined by routine histology and environmental scanning electron microscopy (ESEM).Results: Among 57 patients with sufficient data, 15 had velour interfaces and 42 had silicone. Indications for and duration of support were similar between the groups. The silicone group had shorter incorporation time (45 +/- 22 vs. 56 +/- 34 days, P=. 17) and fewer DLES infections (20% vs. 1.7%, P=. 026, for patient infections and 0.0340 vs. 0.166, P=. 16, for infections per patient-year). Tissues from five patients, three with velour, were examined. Velour interfaces demonstrated more hyperkeratosis, hypergranulosis, and dermal inflammation. By ESEM, the silicone driveline tracts appeared relatively smooth and flat, whereas the velour interface samples were irregular with deep fissures and globular material adhering to the surface.Conclusions: Using the silicone portion of the HMII driveline at the DLES was associated with fewer infections and a trend toward faster healing in this small retrospective series. Whether the intriguing microscopic differences directly account for this needs further study on a larger scale. (C) 2014 Elsevier Inc. All rights reserved.

Objective Surgical ablation with radiofrequency is a safe and effective treatment for atrial fibrillation. Recent advances in instrumentation have allowed for the application of bipolar radiofrequency through a minimally invasive approach using small bilateral thoracotomies for pulmonary vein isolation, destruction of autonomic ganglia, and excision of the left atrial appendage (GALAXY procedure). Methods Thirty-two patients underwent surgical ablation of atrial fibrillation with the GALAXY procedure over a 43-month period. Data were collected in a prospective manner during hospitalization and at 1-, 3-, 6-, and 12-month intervals for rhythm, medications, and subsequent interventions. Results There were no operative mortality, no myocardial infarction, and no stroke. One patient required reexploration for bleeding. Mean follow-up was 28 months (range, 4–43 months). Freedom from atrial fibrillation at 12 and 24 months, respectively, was 90% and 67% for patients with paroxysmal fibrillation and 80% and 63% for patients with persistent atrial fibrillation. Of the patients who were not in sinus rhythm, four reverted to atrial fibrillation and two reverted to atrial flutter. Conclusions The GALAXY procedure is a safe and effective, minimally invasive method for treatment of isolated (lone) atrial fibrillation. The operation provides excellent short-term freedom from atrial fibrillation and should be considered in patients with isolated paroxysmal atrial fibrillation.

We sought to explore the utility of diffuse tensor magnetic resonance imaging (DT-MRI) as a non invasive tool for assessing key remodeling features of the failing human heart.

Background: The HeartMate II (HMII) left ventricular assist device (LVAD) has proven reliable and durable and has become the preferred choice for bridge to transplant therapy (BTT) when compared with the pulsatile HeartMate XVE (XVE). In this study, we compared the post-transplant (PTx) outcomes between XVE and HMII using a large national data registry.Methods: The Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) Thoracic Registry database was queried for all patients implanted with either an XVE or an HMII as BTT during 2004-2009. Statistical analysis between XVE and HMII were performed using Kaplan-Meier survival analysis and Cox regression analyses.Results: A total of 673 patients were implanted with the XVE and 484 with HMII. When adjusted for age, gender, ethnicity, intra-aortic balloon pump, ventilator, inotropes, dialysis, body mass index, creatinine, bilirubin, transfusion, pulmonary capillary wedge, and pulmonary arterial pressures, the HMII had similar one-and three-yr survival (hazard ratio = 0.95, CI = 0.64, 1.42) and rejection-free survival PTx compared to XVE. The XVE group had more early incidences of allograft rejection (AR) and hospitalization for infection (HI).Conclusions: Compared to XVE, patients with HMII have similar one-and three-yr survival after heart transplantation with less risk of early graft rejection and significant infection. With a strong shift toward use of continuous-flow LVADs, PTx outcomes are expected to continue to improve.

Patients increasingly require longer durations of left ventricular assist device (LVAD) therapy. Despite a recent trend toward continuous flow VADs, the HeartMate XVE is still commonly used, but its longevity remains a significant limitation. Existing surveillance methods of pump failure often give inconclusive results. XVE electrical current waveforms were collected regularly (2001–2008) and sorted into quartiles according to number of days until pump failure (Q1, 0–34; Q2, 34–160; Q3, 160–300; and Q4, 300–390 days). Thoratec waveform files were converted into text files. The 10-second electrical current, voltage waveform was identified and isolated for analysis. Waveforms were analyzed by principal component analysis (PCA) and with a fast Fourier transform. Quartiles were compared with analysis of variance (ANOVA). Waveforms (n = 454) were collected for 21 patients with failed pumps. An artificial neural network was used to predict pump failure within 30 days from the waveform characteristics identified though signal processing.

BACKGROUND:Thrombus formation on or near the aortic valve has been reported in HeartMate II (Thoratec, Pleasanton, CA) left ventricular assist device (LVAD) patients whose aortic valves do not open. With an akinetic valve, thrombogenesis is more likely. Thrombus formation may lead to neurologic events, placing the patient at greater risk. Aortic valve stenosis and/or regurgitation have also been observed with akinetic aortic valves. Assessing aortic valve opening is crucial when optimizing rotations per minute (rpm) to minimize embolic risk and aortic valve stenosis but presently relies solely on echocardiography, intermittent decreases in rpms to force aortic valve opening, and monitoring of pulse pressure. We hypothesized the electrical current waveforms of the HeartMate II would reveal whether the aortic valve was opening due to pressure changes in the left ventricle to allow for continuous monitoring and control of aortic valve opening ratios. METHODS:Electrical HeartMate II current waveforms of patients from 2008 to 2009 that were recorded at the time of echocardiograph procedures were analyzed using a modified Karhunen-Loève transformation with a training set of electrical waveforms from 8,860 HeartMate II electrical current recordings from 2001 to 2009. RESULTS:The study included 6 patients. The electrical current magnitude of the projection of the electrical current waveforms onto the training set's eigenvectors was statistically significantly greater in 4 of the 6 patients when the aortic valve was closed, confirmed by echocardiography. The 2 patients who did not have a large increase in the magnitude had mild aortic valve regurgitation. CONCLUSION:Electrical current analysis for rotary non-pulsatile pumps is a means to develop a physiologic feedback algorithm for an auto-mode, which currently does not exist. Constant regulation and optimization of rotary non-pulsatile LVADs would minimize patients' risk for neurologic events and aortic valve stenosis.

Objectives This study investigates alterations in myocardial microvasculature, fibrosis, and hypertrophy before and after mechanical unloading of the failing human heart.Background Recent studies demonstrated the pathophysiologic importance and significant mechanistic links among microvasculature, fibrosis, and hypertrophy during the cardiac remodeling process. The effect of left ventricular assist device (LVAD) unloading on cardiac endothelium and microvasculature is unknown, and its influence on fibrosis and hypertrophy regression to the point of atrophy is controversial.Methods Hemodynamic data and left ventricular tissue were collected from patients with chronic heart failure at LVAD implant and explant (n = 15) and from normal donors (n = 8). New advances in digital microscopy provided a unique opportunity for comprehensive whole-field, endocardium-to-epicardium evaluation for microvascular density, fibrosis, cardiomyocyte size, and glycogen content. Ultrastructural assessment was done with electron microscopy.Results Hemodynamic data revealed significant pressure unloading with LVAD. This was accompanied by a 33% increase in microvascular density (p = 0.001) and a 36% decrease in microvascular lumen area (p = 0.028). We also identified, in agreement with these findings, ultrastructural and immunohistochemical evidence of endothelial cell activation. In addition, LVAD unloading significantly increased interstitial and total collagen content without any associated structural, ultrastructural, or metabolic cardiomyocyte changes suggestive of hypertrophy regression to the point of atrophy and degeneration.Conclusions The LVAD unloading resulted in increased microvascular density accompanied by increased fibrosis and no evidence of cardiomyocyte atrophy. These new insights into the effects of LVAD unloading on microvasculature and associated key remodeling features might guide future studies of unloading-induced reverse remodeling of the failing human heart. (J Am Coll Cardiol 2010;56:382-91) (c) 2010 by the American College of Cardiology Foundation

Driveline exit site (DLES) infection is a persistent problem among the left ventricular assist device (LVAD) patients. This study investigated the relationship between obesity and DLES infection. Records of LVAD patients at two institutions from January 1999 to January 2009 were queried. Results were analyzed using t tests. Those with LVAD support ≥90 days were included. The body mass index (BMI) of each patient was measured at the time of implant and at the conclusion of LVAD support or currently, if the patient was ongoing. Other data included preimplant age, ejection fraction, blood urea nitrogen, creatinine, diabetes, New York Heart Association class, pulmonary capillary wedge pressure, VO2 max, and inotrope therapy. The 118 patients who qualified for the study were placed in an infection group (n = 36) or in the control group (n = 82). Both groups had similar preimplant characteristics. Variables with differences statistically significant between the groups included duration of LVAD support, indication for support, device type, and BMI. Patients who developed DLES infections had a significantly higher BMI and continued weight gain over the course of LVAD therapy compared with the control group. Although this association requires further study, implications for clinical practice may include the provision of nutrition and exercise counseling for patients undergoing LVAD therapy, especially if overweight. These results may warrant increased measures to prevent and treat infection in the preimplant and postimplant periods.

Right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation appears to be associated with increased mortality. However, the determination of which patients are at greater risk of developing postoperative RVF remains controversial and relatively unknown. We sought to determine the preoperative risk factors for the development of RVF after LVAD implantation. The data were obtained for 175 consecutive patients who had received an LVAD. RVF was defined by the need for inhaled nitric oxide for >/=48 hours or intravenous inotropes for >14 days and/or right ventricular assist device implantation. An RVF risk score was developed from the beta coefficients of the independent variables from a multivariate logistic regression model predicting RVF. Destination therapy (DT) was identified as the indication for LVAD implantation in 42% of our patients. RVF after LVAD occurred in 44% of patients (n = 77). The mortality rates for patients with RVF were significantly greater at 30, 180, and 365 days after implantation compared to patients with no RVF. By multivariate logistic regression analysis, 3 preoperative factors were significantly associated with RVF after LVAD implantation: (1) a preoperative need for intra-aortic balloon counterpulsation, (2) increased pulmonary vascular resistance, and (3) DT. The developed RVF risk score effectively stratified the risk of RV failure and death after LVAD implantation. In conclusion, given the progressively growing need for DT, the developed RVF risk score, derived from a population with a large percentage of DT patients, might lead to improved patient selection and help stratify patients who could potentially benefit from early right ventricular assist device implantation.

BACKGROUND The use of left ventricular assist devices (LVADs) as destination therapy (DT) is increasing and has proven beneficial in prolonging survival and improving quality of life in select patients with end stage heart failure Nonetheless, end of-life (EOL) issues are inevitable and how to approach them underreportedMETHODS Our DT data registry was queried for eligible patients defined as those individuals who actively participated in EOL decision making The process from early EOL discussion to palliation and death was reviewed We recorded the causes leading to EOL discussion time from EOL decision to withdrawal and from withdrawal to death and location Primary caregivers were surveyed to qualify their experience and identity themes relevant to this processRESULTS Between 1999 and 2009 92 DT LVADs were implanted in 69 patients Twenty patients qualified for inclusion (mean length of support 833 days) A decrease in quality of life from new/worsening comorbidities usually prompted EOL discussion Eleven patients died at home 8 in the hospital and 1 in a nursing home Time from EOL decision to LVAD withdrawal ranged from <1 day to 2 weeks and from withdrawal until death was <20 minutes in all cases Palliative care was provided to all patients Ongoing assistance from the healthcare team facilitated closure and ensured comfort at EOLCONCLUSIONS With expanding indications and Improved technology, more DT LVADs will be implanted and for longer durations and more patients will face EOL issues A multidisciplinary team approach with protocols involving DT patients and their families in EOL decision making allows for continuity of care and ensures dignity and comfort at EOL J Heart Lung Transplant 2010,29 1337-41 (C) 2010 International Society for Heart and Lung Transplantation All rights reserved

Short-term mechanical circulatory support in the pediatric population with acute cardiac failure has traditionally been limited to extracorporeal membrane oxygenation given the limited availability of pediatric-sized pumps. The Levitronix CentriMag system (Thoratec Corporation, Pleasanton, CA, USA) offers expanded options for short-term support for this population. We report our experience with the successful use of the CentriMag in the pediatric population as a bridge to decision after postcardiotomy ventricular failure and as a bridge to recovery after heart transplantation. The first patient was bridged to a long-term HeartMate II (Thoratec Corporation) as a bridge to potential recovery. The second patient was supported after severe graft failure post heart transplantation, with a full recovery. The Levitronix CentriMag has proven to be a versatile, safe, and effective short-term circulatory support system for our pediatric patients.

Background: The current International Society for Heart and Lung Transplantation (ISHLT) diagnostic criteria for antibody-mediated rejection (AMR) designate AMR as either absent (AMR 0) or present (AMR 1), without grading its severity. Yet, the extent of histologic and immunofluorescence (IF) findings of AMR varies across endomyocardial biopsies (EMBs). In this study, we hypothesized that the severity of AMR, as assessed on EMBs, correlates with cardiovascular mortality in heart transplant recipients.Methods: All EMBs from 1985 to 2005 were evaluated. Biopsy specimens were uniformly studied by light microscopy and IF early post-transplant. A comprehensive vascular score (V1: no AMR, to V5: severe AMR) was prospectively assigned to each EMB, based on severity of both histologic and IF findings. Univariate Cox proportional hazards regressions were performed using indicators of vascular scores alone, combined, and cumulatively.Results: Nine hundred six patients were transplanted and included in the study. Mean age was 46.6 +/- 15.5 years and 82% were male. A total of 26,236 EMBs comprised the study data. As expected, histologic and immunopathologic findings of AMR varied in severity. An incremental risk of cardiovascular mortality was found with more severe AMR whether vascular scores were analyzed individually (p 0.001), in combination (p = 0.01) or Cumulatively (p = 0.006).Conclusions: The severity of AMR on EMBs correlates with an incremental cardiovascular mortality risk after heart transplantation, suggesting that AMR should be viewed as a spectrum rather than just as present or absent. Supplementing the ISHLT AMR diagnostic guidelines with a consensus severity scale is warranted. J Heart Lung Transplant 2009;28:51-7. Copyright (C) 2009 by the International Society for Heart and Lung Transplantation.

An increasing number of patients are living with ventricular assist devices (VADs). Many of these patients will require noncardiac surgery for conditions not directly related to their VADs. The aim of this study was to assess the risks and outcomes of noncardiac surgery in these patients. Perioperative and follow-up data from patients with VADs who underwent noncardiac surgery from 1993 to 2006 were analyzed. In that period, 184 VADs were implanted in 155 patients. Thirty-seven patients (24%) subsequently underwent 59 noncardiac surgeries. The mean duration of VAD support before surgery was 229 days. Bleeding was the most common postsurgical complication (10%), necessitating reexploration in 20% of abdominal surgeries. Thirty-day mortality was 12%. No deaths were caused by direct complications of surgery. Successful transplantation occurred in 72% of bridge to transplantation patients who required noncardiac surgery, compared with 71% of these patients who did not require noncardiac surgery (relative risk 1.0, p = 0.9). The average duration of VAD support after noncardiac surgery for destination therapy patients was 324 days, most of which time was spent at home. In conclusion, outcomes after noncardiac surgery in patients with VADs are favorable, and most patients continue to benefit from the intended purpose of mechanical circulatory support after recovering from noncardiac surgery.

Left ventricular assist device (LVAD) implantation before heart transplantation has been associated with formation of antibodies directed against human leukocyte antigens (HLA), often referred to as sensitization. This study investigated whether prior sensitization or LVAD type affected the degree of post-implantation sensitization. The records of consecutive HeartMate (HM) I and HM II LVAD patients were reviewed. Panel reactive antibody (PRA) was assessed before LVAD implantation and biweekly thereafter. Sensitization was defined as PRA > 10%, and high-degree sensitization was defined as PRA > 90%. An HM LVAD was implanted in 64 patients, and 11 received a HM II LVAD as a bridge to transplant. Ten HM I patients (16%) were sensitized before LVAD implantation (HM I-S), and 54 (84%) were not (HM I-Non-S). Nine HM I-S patients (90%) became highly sensitized (PRA > 90%) compared with 9 HM I-Non-S patients (16.7%; p < 0.001). The PRA remained elevated (> 90%) in 8 of the 9 (88.9%) highly sensitized HM I-S patients vs 5 of the 9 (55.6%) HM I-Non-S highly sensitized patients. The PRA levels in the rest of the HM I-S highly sensitized patients declined from 93% +/- 4% to 55% +/- 15% (p = 0.01). Among the 11 HM II patients, 1 (9%) was sensitized before LVAD implantation (PRA, 40%) and the PRA moderately increased to 80%. No other HM II patient became sensitized after implantation. Thus, 1 of 11 (9%) HM II patients became sensitized compared with 29 of 64 (45%) HM I patients (p = 0.04). Pre-sensitized patients are at higher risk for becoming and remaining highly HLA-allosensitized after LVAD implantation. The HeartMate II LVAD appears to cause less sensitization than HeartMate I.