Long-term Left Ventricular Assist Device Research Articles

(682) - Impact of Atrial Fibrillation on Pump Thrombosis and Thromboembolic Events in Long-Term Left Ventricular Assist Device Therapy

(682) - Impact of Atrial Fibrillation on Pump Thrombosis and Thromboembolic Events in Long-Term Left Ventricular Assist Device Therapy

Abstract WMP77: Neurovascular Complications During Long-term Left Ventricular Assist Device (LVAD) Support: Single Center Experience

Introduction: Left ventricular assist devices (LVAD) have emerged as the standard of care for treating patients with advanced heart failure refractory to maximal medical therapy. Postoperative cerebrovascular complications are an important cause of morbidity and decreased quality of life. However, the literature contains little data on the incidence, predictors, and outcome of stroke. Hypothesis: We aimed to determine the incidence of cerebrovascular complications, their type, and association with stroke risk factors and anticoagulation therapy. Methods: Data were collected prospectively on all patients with LVADs implanted at BWH. Categorical variables were tested by Chi-square. Results: From 2007 to 2015, 151 patients (123 male; median age 57) underwent implantation of HeartMate II LVAD: 79 bridge to transplant, 62 destination therapy, and 10 bridge to candidacy. Strokes occurred in 31 patients (21%). Risk of stroke did not correlate with sex (25 male, 6 female) or age (median at stroke onset 57). Seventeen acute ischemic strokes (AIS) occurred in 16 patients and 17 intracerebral hemorrhages (ICH) occurred in 15 patients. Four of the AIS were complicated by secondary hemorrhage. Events occurred at a mean of 362 days from implantation (range 5 days-6 years 8 months). All patients except one were on warfarin at time of stroke (goal INR 2-3.5). Mean INR at AIS onset was 2.3 compared to 3.0 for ICH. Of the 15 ICH patients, 3 had supratherapeutic INR > 3.5. Eleven of the 16 AIS patients were also receiving ASA, 1 ASA + dipyridamole, 1 ASA + dipyridamole + bivalirudin. One received ASA only. All ICH patients and all those with AIS with secondary hemorrhage were on ASA. Patients with COPD were more likely to have a stroke (p = 0.0006); 30 of the 151 patients had COPD and 13 of them (43%) had strokes. Risk of stroke did not correlate with DM, HTN, hyperlipidemia, CKD, PAD, AF, or prior stroke. Nineteen of 31 patients with stroke versus 22 of 120 without stroke died (mortality 61 v 18 %; p << 0.001). Conclusions: Stroke is an important cause of major morbidity and mortality in patients on LVAD support. Patients with COPD are at an increased risk of stroke. Further studies addressing post-LVAD stroke risk, prevention, and treatment are warranted.

0377: Can we predict right heart failure after implantable left ventricular assist device?

The right ventricular failure (RVF) is a severe complication after implantation of a left ventricular assist device (LVAD), difficult to predict and treat. The purpose of this study was to identify risk factors of RVF after mechanical circulatory support. This is a single-center prospective cohort of patients with long-term electrical intracorporeal continuous flow LVAD type HeartMate II between January 2008 and September 2014. We searched predictors of RVF, defined by a need of inhaled nitric oxide ≥48 hours and / or intravenous inotropes ≥14 days. 42 devices were implanted in 36 men and 6 women with a mean age of 57.3 years, for 30 ischemic and 12 primitive cardiomyopathies, 10 cases in “Destination Therapy” and 32 cases in “Bridge-to-Transplantation.” The 30-day mortality was 6 patients, 1-year survival of 84%, the mean last of intubation was 7 days and ICU stay of 16.3 days. There were 16 cases of RVF (38.1%). The significantly associated factors (p<0.05) were: subaortic time velocity integral (10.5 versus 13.8cm), grade (1.4 versus 0.3) and maximal speed of the triscuspid regurgitation (3 versus 3.5 m/s), fractional shortening (27 versus 36.4%) and surface of the right ventricle (33.4 versus 22cm 2 ), capillary (26.3 versus 18.3mmHg) and mean pulmonary arterial pressures (38.7 versus 27.2mmHg), transpulmonary gradient (14 versus 8.5mmHg), pulmonary arterial resistances (3.7 versus 2.7 UW), right ventricular (26 versus 8.1mmHg) and atrial pressures (11 versus 5.5mmHg), bilirubin (28.3 versus 15.7 µmol/l), INTERMACS score (3.3 versus 4.4), non-ischemic etiologies (50 versus 85%) and preoperative inotropic drugs (56 versus 15%). RVF remains a major complication in implantable LVAD. According to the literature, preoperative pulmonary hypertension, right systolic dysfunction and cavitary dilation seem to favor its appearance.

Outcomes of contemporary mechanical circulatory support device configurations in patients with severe biventricular failure

ObjectivesSevere right ventricular failure often is considered a contraindication for left ventricular assist device (LVAD) therapy and necessitates use of biventricular assist devices (BiVADs). Available options for BiVADs are limited, and comparative outcomes are largely unknown. MethodsHeart transplant candidates who were registered on the United Network for Organ Sharing waitlist and underwent long-term contemporary LVAD (n = 3195) or BiVAD (n = 408) implantation, from January 2010 through June 2014, were retrospectively analyzed. We evaluated clinical characteristics and outcomes of patients requiring a BiVAD, as well as regional differences in utilization of this technology. ResultsPatients requiring a BiVAD were younger (48.9 vs 53.3 years), had a higher proportion of nonischemic disease (69.1% vs 58.2%), a higher bilirubin level (0.9 vs 0.7 mg/dL), and a lower 6-month survival rate (68.1% vs 92.7%) after device implantation (all P < .05). Postimplantation and posttransplantation survival was comparable for commonly used BiVAD configurations, including total artificial heart, continuous flow BiVAD, a continuous-flow LVAD coupled with a right-sided device, and pulsatile flow. Significant variation was found in regional utilization of these devices, regardless of differences in transplantation waitlist times. A large body surface area was an independent predictor of mortality on a BiVAD (hazard ratio = 2.12, P = .017). ConclusionsOutcomes of patients requiring a BiVAD remain poor in the contemporary device era, regardless of the configuration used. Among other clinical factors, body surface area should be incorporated into decision making for device selection in these patients.

Left Ventricular Assist Device Driveline Infections

Heart failure is a chronic progressive disease that affects millions of people in the United States. Although medical management of heart failure has helped improve quality of life and survival, end-stage heart failure ultimately requires a heart transplant or long-term left ventricular assist device (LVAD) support. With more patients awaiting transplant, the demand for hearts outweighs the supply of donor hearts. The use of LVADs is increasing in patients with advanced heart failure as a treatment option for those awaiting a heart transplant or as a long-term solution if they are ineligible for a transplant. Although the LVAD is a marvel of modern medicine, infection is a cause of concern because today’s LVADs are powered externally through a percutaneous driveline that can be a major source of infection.

Serum Brain Natriuretic Peptide Concentration 60 Days After Surgery as a Predictor of Long-Term Prognosis in Patients Implanted With a Left Ventricular Assist Device

Mechanical circulatory support by a left ventricular assist device (LVAD) is used to bridge patients with advanced heart failure to transplant or as a definitive treatment. We retrospectively sought predictors of long-term outcome in a cohort of 83 patients who had undergone LVAD treatment. We subjected perioperative clinical data of patients to statistical analysis to establish parameters associated with all-cause mortality, and the cutoff values, sensitivity, and specificity of those that had a statistically significant relation with survival. Mean follow-up was 717 days (standard deviation, 334 days; range, 17-1,592 days). Fourteen patients (16.8%) died, but nine (10.8%) were weaned from support. Serum brain natriuretic peptide (BNP) concentration measured 60 days after implantation was significantly associated with all-cause mortality. The optimal BNP cutoff value to predict death during LVAD support was 322 pg/ml, with a sensitivity of 71.4% and specificity of 79.8%. Two-year survival was 92.0% in those with 60 days serum BNP concentration <322 pg/ml compared with 70.5% in those in whom it was ≥322 pg/ml (p = 0.003). The relation between BNP and survival likely reflects recovery of native myocardial function and improvements in global health and should assist clinicians in the on-going management of long-term LVAD therapy.

Abstract 374: Characteristics and Clinical Outcomes of Patients with Long-term Left Ventricular Assist Devices in Quebec Compared with the INTERMACS Registry

Background: After a review of the evidence, our publicly funded cardiology evaluation unit recommended to the Quebec Ministry of Health that use of long-term left ventricular assist devices (LVAD) should be carefully monitored and not limited to bridge-to-transplant patients. Herein, we describe use and clinical outcomes of LVAD in Quebec during the latest 5-year period in comparison with results reported by the INTERMACS registry. Methods: A retrospective review of all pertinent hospital data sources of all LVAD-implanted patients in 2010-14 was performed with follow-up of major clinical outcomes to January 2015. Results: In Quebec’s 3 LVAD centers, 83 LVADs were implanted during 2010-14. Annual center patient volume varied from 0 to 24. Patients were mostly male (80%). Median age was 56 years (interquartile range, IQR: 45-62). The proportion of patients ≥ 60 years was 35% versus 49.5% in INTERMACS. For INTERMACS profiles that include inotrope dependence, the proportions of Quebec patients were very similar to INTERMACS for profile 1 (critical cardiogenic shock; 13% vs 15%, respectively) and profile 2 (progressive decline; 36% vs 36%) but higher for profile 3 (stable but inotrope dependent; 40% vs 30%). The proportion of patients who were not on the transplant list at the time of implantation was lower in Quebec (53%; 44/83) than in INTERMACS (78%) and destination therapy was much less frequent (11% [9/83] vs 43%). For patients implanted during 2010-13 (n=65), 1-year major clinical outcomes in Québec were very similar to INTERMACS (2006-2013): deaths, 17% vs 18%; cardiac transplantation, 22% vs 20%; LVAD removal because of myocardial recovery, 3% vs 1%; alive with LVAD support, 58% vs 61%. Clinical results at 1 year were similar for Quebec patients on and not on the transplant list at the time of implant (p=0.11). Two-thirds of the cohort had 2-year follow-up: 21% (12/56) died; 43% (24/56) had transplantation; 5% recovered and had LVAD removal; and 30% (17/56) were alive with LVAD. For patients implanted during 2014 (n=18), the median duration of follow-up was about 5 months and 5.6% had died on LVAD support. Among all Quebec patients (2010-2014), most recent follow-up indicates that 26% (9/32) of patients transplanted after LVAD support have died. Conclusions: In comparison with INTERMACS, Quebec LVAD patients were younger, more likely to be inotrope-dependent and less likely to be implanted as destination therapy. Despite relatively low center volumes, clinical outcomes for Quebec were very similar to INTERMACS. Results according to transplant list status at time of implant support the recommendation that transplant eligibility should not be an essential criterion for selection of patients for LVAD. Continued independent monitoring of LVAD patients, even after explant or transplant, will be important to optimize the value and quality of care of end-stage heart failure patients.

Temporary left ventricular assist device through an axillary access is a promising approach to improve outcomes in refractory cardiogenic shock patients.

Cardiogenic shock (CS) causes significant morbidity and mortality and such patients can deteriorate rapidly. Temporary left ventricular assist devices (LVADs) are a promising approach to manage these patients. The following is a case series in which patients stabilized with a temporary LVAD for CS improvement were analyzed retrospectively. Between June 2011 and January 2014, 15 patients received temporary devices through an axillary approach (mean age: 53 ± 15, 93% male). Mean survival time was 317.8 ± 359.5 days (range: 6-936 days). During support there were no major bleeding events, infectious complications at the axillary access site, upper extremity edema, or emboli. The most of the patients recovered from CS (93%) were mobilized (67%) and were extubated (73%) while on temporary device support. Median times to extubation, intensive care unit discharge, and discontinuation of inotropic medications were: 1.63, 18, and 15 days, respectively. Four patients recovered to no device support and five received a long-term LVAD, all of whom remain alive. Therefore, implantation of a temporary LVAD through an axillary approach is a promising therapy for improving outcomes in patients needing mechanical circulatory support as a bridge to recovery or a definitive LVAD.

Lessons learned from 150 continuous-flow left ventricular assist devices: a single institutional 7 year experience.

Continuous-flow (CF) left ventricular assist devices (LVADs) have become the standard of care for patients with advanced heart failure refractory to optimal medical therapy. The goal of this study was to review our 7 year single institutional experience with CF LVADs. Mean age was 50.4 + 12.5 (17-69) years for bridge-to-transplantation (BTT) patients and 57.6 + 10.4 (31-81) years for destination therapy (DT) patients (p < 0.001). Overall, 38 patients (26%) were female and 58 (41%) were African American. Etiology of heart failure was ischemic in 54 patients (37%) and nonischemic in 93 patients (63%). Overall survival at 30 days, 6 months, 12 months, and 2 years was 93%, 89%, 84%, and 81%, respectively. Gastrointestinal bleeding (GIB) was the most common complication (24%), followed by stroke (18%), right ventricular (RV) failure (18%), ventilator-dependent respiratory failure (10%), reoperation for bleeding (10%), and driveline infection (9%). These data demonstrate excellent survival with low mortality for both BTT and DT patients on long-term LVAD support. However, for LVAD therapy to become the gold standard for long-term treatment of end-stage heart failure and a plausible alternative to heart transplantation, we need to continue to improve the incidence of frequent postoperative complications, such as RV failure, driveline infections, strokes, and GIB.

A new Bayesian network-based risk stratification model for prediction of short-term and long-term LVAD mortality.

Existing risk assessment tools for patient selection for left ventricular assist devices (LVADs) such as the Destination Therapy Risk Score and HeartMate II Risk Score (HMRS) have limited predictive ability. This study aims to overcome the limitations of traditional statistical methods by performing the first application of Bayesian analysis to the comprehensive Interagency Registry for Mechanically Assisted Circulatory Support dataset and comparing it to HMRS. We retrospectively analyzed 8,050 continuous flow LVAD patients and 226 preimplant variables. We then derived Bayesian models for mortality at each of five time end-points postimplant (30 days, 90 days, 6 month, 1 year, and 2 years), achieving accuracies of 95%, 90%, 90%, 83%, and 78%, Kappa values of 0.43, 0.37, 0.37, 0.45, and 0.43, and area under the receiver operator characteristic (ROC) of 91%, 82%, 82%, 80%, and 81%, respectively. This was in comparison to the HMRS with an ROC of 57% and 60% at 90 days and 1 year, respectively. Preimplant interventions, such as dialysis, ECMO, and ventilators were major contributing risk markers. Bayesian models have the ability to reliably represent the complex causal relations of multiple variables on clinical outcomes. Their potential to develop a reliable risk stratification tool for use in clinical decision making on LVAD patients encourages further investigation.

Prophylactic Subclavian Artery Intraaortic Balloon Counter-Pulsation is Safe in High-Risk Cardiac Surgery Patients.

Mechanical circulatory support by a left ventricular assist device (LVAD) is used to bridge patients with advanced heart failure to transplant or as a definitive treatment. We retrospectively sought predictors of long-term outcome in a cohort of 83 patients who had undergone LVAD treatment. We subjected perioperative clinical data of patients to statistical analysis to establish parameters associated with all-cause mortality, and the cutoff values, sensitivity, and specificity of those that had a statistically significant relation with survival. Mean follow-up was 717 days (standard deviation, 334 days; range, 17–1,592 days). Fourteen patients (16.8%) died, but nine (10.8%) were weaned from support. Serum brain natriuretic peptide (BNP) concentration measured 60 days after implantation was significantly associated with all-cause mortality. The optimal BNP cutoff value to predict death during LVAD support was 322 pg/ml, with a sensitivity of 71.4% and specificity of 79.8%. Two-year survival was 92.0% in those with 60 days serum BNP concentration <322 pg/ml compared with 70.5% in those in whom it was ≥322 pg/ml (p = 0.003). The relation between BNP and survival likely reflects recovery of native myocardial function and improvements in global health and should assist clinicians in the on-going management of long-term LVAD therapy.

(513) - Rest and Exercise Adaptation of the Right Ventricle in Long-Term Left Ventricular Assist Device Patients: A Prospective, Pilot Study

(513) - Rest and Exercise Adaptation of the Right Ventricle in Long-Term Left Ventricular Assist Device Patients: A Prospective, Pilot Study

Left ventricular assist devices: a kidney's perspective.

The left ventricular assist device (LVAD) has become an established treatment option for patients with refractory heart failure. Many of these patients experience chronic kidney disease (CKD) due to chronic cardiorenal syndrome type II, which is often alleviated quickly following LVAD implantation. Nevertheless, reversibility of CKD remains difficult to predict. Interestingly, initial recovery of GFR appears to be transient, being followed by gradual but significant late decline. Nevertheless, GFR often remains elevated compared to preimplant status. Larger GFR increases are followed by a proportionally larger late decline. Several explanations for this gradual decline in renal function after LVAD therapy have been proposed, yet a definitive answer remains elusive. Mortality predictors of LVAD implantation are the occurrence of either postimplantation acute kidney injury (AKI) or preimplant CKD. However, patient outcomes continue to improve as LVAD therapy becomes more widespread, and adverse events including AKI appear to decline. In light of a growing destination therapy population, it is important to understand the cumulative effects of long-term LVAD support on kidney function. Additional research and passage of time are required to further unravel the intricate relationships between the LVAD and the kidney.

Left Ventricular Assist Device Driveline Infections: The Achilles' Heel of Destination Therapy.

Heart failure is a chronic progressive disease that affects millions of people in the United States. Although medical management of heart failure has helped improve quality of life and survival, end-stage heart failure ultimately requires a heart transplant or long-term left ventricular assist device (LVAD) support. With more patients awaiting transplant, the demand for hearts outweighs the supply of donor hearts. The use of LVADs is increasing in patients with advanced heart failure as a treatment option for those awaiting a heart transplant or as a long-term solution if they are ineligible for a transplant. Although the LVAD is a marvel of modern medicine, infection is a cause of concern because today's LVADs are powered externally through a percutaneous driveline that can be a major source of infection.

Principles of HeartMate II implantation to avoid pump malposition and migration.

Proper left ventricular assist device (LVAD) insertion will help maximize LVAD flow and may reduce adverse events such as right heart failure and pump thrombosis. Although no standardized insertion technique has been universally accepted, the goals are: unobstructed inflow cannula, unobstructed outflow graft with avoidance of right ventricular compression, and prevention of pump migration. To achieve these objectives for the HeartMate II LVAD, we delineate four principles: proper pump pocket creation, optimized positioning of inflow cannula and outflow graft, proper pump position in the body, and fixation. These basic principles are easy to implement and have been beneficial in our patients, assuring long-term unobstructed LVAD flow.

Abstract 15253: A Paradoxical Rise in Serum Copeptin After Non-Pulsatile LVAD: a New SIADH?

Introduction: Hyponatremia (Na&lt; 136 mmol/L) is prevalent (~28%) among hospitalized heart failure (HF) patients and a marker of advanced/end-stage HF(AHF) with increased mortality. Treatment of hyponatremia has no survival benefit in this population. In a prospective study of AHF patients, we sought to define the prevalence, pathophysiology and role of V2 vasoreceptor activity in the development of hyponatremia. Serum copeptin (S-COP), a surrogate marker for AVP activity, was assessed during AHF therapies (AHFT) which included axial-non-pulsatile left ventricular assist device (LVAD) and/or heart transplant (HTx). Methods: Serum samples were collected from AHF patients pre and post AHFT and compared with normal controls. S-COP levels were assessed using an enzyme linked immunosorbant assay and correlated to clinical variables, serum Sodium (S-Na) and glomerular filtration rate (eGFR). Results: Among 89 consecutive (mean age 56.2±15.35; M=69) patients awaiting AHFT, 54 (60%) were hyponatremic. Preop S-COP was elevated compared to controls (0.68±0.50 vs 0.53±0.13 ng/ml, P=.02) and inversely correlated to S-Na and eGFR (r=-0.23, P&lt;.05, r=-0.23, P&lt;.05; N=81); conversely, eGFR and S-Na were uncorrelated. AHFT (n=42) normalized S-Na (133.2±4.1 vs 136.1±3.5 mmol/l; P=.001) and improved eGFR (47.7±13.6 vs 52.7±9.7 mL/min/1.73sqm; P=.001); however, post LVAD (n=34) S-COP rose (0.67±0.21 vs 1.84±0.76 ng/ml; P&lt;.0001) with incomplete normalization of S-NA (132.9±4.3 vs 135.9±3.8 mmol/l; P&lt;.01). In contrast, post HTx (n=9) S-COP was unchanged to pre-AHFT (0.59±0.32 vs 0.65±0.16 ng/ml; P&gt;.1) and was lower compared to post LVAD (0.65±0.16 vs 1.84±0.76 ng/ml; P&lt;.0001). Elevated S-COP with LVAD as bridge to transplant (n=3) showed a marked decrease post HTx (2.7±0.50 vs 1.0±0.29 ng/ml; P&lt;.01). Conclusions: In AHF, the prevalence of hyponatremia is double compared to acute hospitalized HF and associated with S-COP surge prior to AHFT. Unexpectedly, LVAD but not HTx was associated with rising S-COP and incomplete S-Na recovery despite clinical improvement, suggesting inappropriate antidiuretic hormone release. The association of S-COP rise with non-pulsatile LVAD and potential benefit of long-term AVP inhibition post LVAD merits further studies.

Abstract 17964: Right Ventricular Reverse Remodeling during Long-Term Continuous-Flow Left Ventricular Assist Device Support in Patients with Dilated Cardiomyopathy

Introduction: Although right ventricle (RV) failure as well as left ventricle (LV) failure can be of major concern in the treatment for severe heart failure, in clinical situation, only LV assist devices (LVAD) have been implanted despite the presence of RV failure. However, the circulatory and histological changes in the failed RV after long term continuous-flow (CF)-LVAD support have not been fully elucidated. In this study, we hypothesized that CF-LVAD long term support may ameliorate RV failure and have a positive impact on the distressed pathology of RV. Methods: This study included 16 dilated cardiomyopathy (DCM) patients who required long-term LVAD support, for 852 ± 84(129-1607) days, before heart transplantation (HTx). Echocardiograms were performed to analyze LV and RV functions. Transmural LV tissues and RV tissues sampled before LVAD implantation and after LVAD explantation were histopathologically analyzed for LV and RV remodeling. Results: Echocardiography showed significantly reduced LV end-diastolic and end-systolic dimensions during CF-LVAD support (73 ± 11 mm to 63 ± 13.6 mm, 67 ± 12 mm to 57 ± 17 mm, P&lt;0.05, respectively). Regarding RV function, right ventricular end-diastolic dimension (RVDd) tended to decrease (48 ± 11 mm to 43 ± 10 mm, P=0.10) and the trans tricuspid pressure gradient (TRPG) was significantly decreased during long-term LVAD support (31 ± 14.8 mmHg to 12 ± 3.2 mmHg, P=0.01). Histopathologically, the sizes of cardiomyocytes in both the LV and the RV were significantly decreased during CF-LVAD support (left: 33.1±5.1 μm to 29.1±4.0 μm, P=0.05, right: 25.5 ± 2.4 μm to 21.6 ± 3.2 μm, P=0.01) and interstitial fibrosis tended to decrease in the RV (29.5 ± 3.1 % to 19.7 ± 7.2 %, P=0.10) despite there being no change in the LV (24.9 ± 10.8 % to 27.1 ± 12.1 %, P=0.14). Conclusion: Long-term CF-LVAD support ameliorates RV failure, possibly by reducing afterload on the RV followed by unloading of LV pressure overload, and thereby exerts a positive impact on RV reverse remodeling.

Abstract 18178: Cardiac Index Declines During Long-term LVAD Support

Background: It is increasingly common for patients to be supported by left ventricular assist devices (LVADs) for an extended period of time. At our institution, we have anecdotally noticed a decline in functional status during the course of prolonged LVAD therapy. Our objective was to analyze hemodynamic and echocardiographic data of patients with at least 2 years of ongoing LVAD support. Methods: We retrospectively reviewed all patients who underwent HeartMate II implantation between 2005 and 2012. Of the 131 patients reviewed, we identified 20 patients who were supported by LVADs for at least 2 years and had right heart catheterization (RHC) in both the initial postoperative period and at 2-3 year follow-up. No patients were on inotropic therapy at the time of RHC. Results: The mean times of initial and follow-up post-LVAD RHCs were 59 ± 41 days and 889 ± 160 days, respectively. Cardiac index (CI) declined by an average of 0.4 L/min/m2 over the study period (p=0.04). Other than a reduction in transpulmonary gradient, no other hemodynamic differences were observed. There was a statistically significant worsening of aortic insufficiency (AI) at follow-up. However, when dichotomized by the median change in CI (-0.4 L/min/m2), there is no difference in AI between groups (p =0.60). In fact, 2 of the 3 patients with moderate AI had an increase in CI. There were no differences in pump speed, mean pressure, aortic valve opening, or lactate dehydrogenase between initial and follow up periods (Table 1). Conclusion: In the first study to report long term hemodynamic follow up in patients supported by HeartMate II LVADs, cardiac index significantly declined over time. The decline was not the result of worsening right ventricular function or valvular regurgitation nor a difference in pump speed or blood pressure. This is a potentially worrisome finding, especially for destination therapy patients. Further studies are needed to understand what factors may contribute to this decline.

Relationship of tricuspid repair at the time of left ventricular assist device implantation and survival.

Tricuspid regurgitation contributes to right ventricular failure (RVF) and is associated with worse clinical outcomes in patients undergoing left ventricular assist device (LVAD) treatment. However, whether tricuspid valve repair (TVR) at the time of LVAD implantation improves outcomes is not clear. We identified all patients undergoing initial implantation of a long-term continuous-flow LVAD at our institution from March 2006 to August 2011. We assessed the impact of TVR on survival and incidence of RVF using Kaplan-Meier curves and proportional hazards regression adjusted for age, gender, baseline tricuspid regurgitation, RV function, MELD score, albumin, and indication (bridge vs. destination). A total of 101 patients were included in the analysis, of which 14 patients underwent TVR concomitant LVAD. All TVR patients had moderate or severe baseline regurgitation. Crude survival was not different between groups. In multivariable models adjusted for confounding factors, TVR showed a significant association with improved survival (HR = 0.1, p = 0.049). Adjusted models showed no difference in RVF. In this cohort of patients, TVR at the time of LVAD implantation appears associated with better survival. Additional larger studies are needed to verify the effect of TVR at the time of LVAD implantation, and whether it should be utilized more frequently.

Hypertension: an unstudied potential risk factor for adverse outcomes during continuous flow ventricular assist device support.

In end-stage heart failure, left ventricular assist devices (LVADs) represent an exciting new frontier in which post-device implantation survival approaches that of heart transplant. However, expansion of this technology is still limited by complications that impact morbidity and mortality. Thus, it is essential to identify and optimize modifiable predictors of poor outcomes. One such predictor may be hypertension (HTN). Not only may chronic HTN as a traditional cardiovascular risk factor be present during long-term LVAD support, but HTN may also contribute to device malfunction or device-associated complications. Although current guidelines identify blood pressure (BP) control as important to outpatient continuous flow (CF) LVAD management, there is no evidence base to support these guidelines. Indeed, our comprehensive literature search did not identify any studies that evaluated post-device implantation HTN as a potential predictor of adverse CF-LVAD outcomes. HTN among CF-LVAD patients is likely a relatively unstudied factor because of difficulties using standard noninvasive techniques to measure BP in the setting of reduced pulsatile flow. Fortunately, recent research has elucidated the meaning of Doppler BP measurements and validated a slow-cuff deflation system for BP measurements in the setting of CF-LVAD support. Therefore, CF-LVAD researchers and clinicians may (1) consider potential mechanisms relating HTN to poor outcomes, (2) realize that HTN management is a stated goal despite scarce evidence, and (3) utilize the new reliable and valid methods for outpatient BP measurement that make research and management possible. It is critical and now feasible that research on HTN in the CF-LVAD patient population move forward.