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Clinical characteristics and outcomes of patients requiring prolonged inotropes after left ventricular assist device implantation
Abstract
Background
Limited data exists regarding patients with continuous flow left ventricular assist device (LVAD) support who require long‐term inotropes. Our primary objective was to evaluate the clinical characteristics and all‐cause mortality of LVAD recipients with prolonged inotrope use (PIU). Secondary endpoints were to compare predictors of PIU, mortality, risk of late re‐initiation of inotropes, time to gastrointestinal bleed (GIB), infection and arrhythmias.
Methods
Retrospective cohort study on adult patients with primary continuous flow LVADs implanted during January 2008 to February 2017 followed through February 2018. We defined PIU as ≥14 days of inotrope support. Kaplan–Meier method, competing risk models and Cox‐proportional hazard models were used.
Results
Final analytic sample was 203 patients, 58% required PIU and 10% were discharged on inotropes. There was no difference in pre‐implant characteristics. One‐year survival rate was 87% if no PIU required, 74% if PIU required and 72% if discharged on inotropes. PIU was associated with longer length of stay and higher incidence of GIB. We found no association between PIU and late re‐initiation of inotropes, infection or arrhythmias. Adjusted hazard risk of death was increased in patients with PIU (HR=1.66, p=0.046), older age (HR=1.28, p=0.031) and higher creatinine levels (HR=1.60, p=0.007).
Conclusion
Prolonged inotrope use is frequently encountered following LVAD implantation and associated with adverse prognosis but remains a therapeutic option. Inability to wean inotropes prior to hospital discharge is a marker of patients at particularly higher risk of mortality following LVAD implantation.
... INTERMACS grades RVF severity according to the duration of required therapy [mainly nitric oxide (iNO) and inotropes] with 0-7 days of support defined as mild RVF, 7-14 days considered moderate RVF, and >14 days or need for RVAD was defined as severe RVF (5). Subsequent studies have demonstrated that only severe, INTERMACS-defined RVF is associated with worse outcomes (6,7). Thus, it seems reasonable to consider a clinically relevant episode of RVF as only those episodes that require RVAD or inotropic support for >14 days, acknowledging that prognosis worsens with duration (8,9). ...
Left ventricular assist devices (LVADs) are increasingly common across the heart failure population. Right ventricular failure (RVF) is a feared complication that can occur in the early post-operative phase or during the outpatient follow-up. Multiple tools are available to the clinician to carefully estimate the individual risk of developing RVF after LVAD implantation. This review will provide a comprehensive overview of available tools for RVF prognostication, including patient-specific and right ventricle (RV)-specific echocardiographic and hemodynamic parameters, to provide guidance in patient selection during LVAD candidacy. We also offer a multidisciplinary approach to the management of early RVF, including indications and management of right ventricular assist devices in this setting to provide tools that help managing the failing RV.
Late right heart failure (RHF) is increasingly recognized in patients with long-term left ventricular assist device (LVAD) support and is associated with decreased survival and increased incidence of adverse events such as gastrointestinal bleeding and stroke. Progression of right ventricular (RV) dysfunction to clinical syndrome of late RHF in patients supported with LVAD is dependent on the severity of pre-existing RV dysfunction, persistent or worsening left- or right-sided valvular heart disease, pulmonary hypertension, inadequate or excessive left ventricular unloading, and/or progression of the underlying cardiac disease. RHF likely represents a continuum of risk with early presentation and progression to late RHF. However, de novo RHF develops in a subset of patients leading to increased diuretic requirement, arrhythmias, renal and hepatic dysfunction, and heart failure hospitalizations. The distinction between isolated late RHF and RHF due to left-sided contributions is lacking in registry studies and should be the focus of future registry data collection. Potential management strategies include optimization of RV preload and afterload, neurohormonal blockade, LVAD speed optimization, and treatment of concomitant valvular disease. In this review, the authors discuss definition, pathophysiology, prevention, and management of late RHF.
Aortic valve disorders are important considerations in advanced heart failure patients being evaluated for left ventricular assist devices (LVAD) and those on LVAD support. Aortic insufficiency (AI) can be present prior to LVAD implantation or develop de novo during LVAD support. It is usually a progressive disorder and can lead to impaired LVAD effectiveness and heart failure symptoms. Severe AI is associated with worsening hemodynamics, increased hospitalizations, and decreased survival in LVAD patients. Diagnosis is made with echocardiographic, device assessment, and/or catheterization studies. Standard echocardiographic criteria for AI are insufficient for accurate diagnosis of AI severity. Management of pre-existing AI includes aortic repair or replacement at the time of LVAD implant. Management of de novo AI on LVAD support is challenging with increased risks of repeat surgical intervention, and percutaneous techniques including transcatheter aortic valve replacement are assuming greater importance. In this manuscript, we provide a comprehensive approach to contemporary diagnosis and management of aortic valve disorders in the setting of LVAD therapy.
Background
It is critical to identify patients at increased risk of right ventricular failure (RVF) before left ventricular assist device (LVAD) implantation. Pulmonary artery pulsatility index (PAPi) is a hemodynamic parameter that is a specific measure of right ventricular function and may better identify LVAD recipients at risk for RVF. This systematic review analyzes the predictive value of preoperative PAPi to RVF in the setting of LVAD implantation.
Methods
Databases were searched for all studies reporting on PAPi and RVF after LVAD implantation. Data collected included: number of patients, patient characteristics, incidences of RVF, PAPi, central venous pressure (CVP), CVP/pulmonary capillary wedge pressure (PCWP), tricuspid annular plane systolic excursion (TAPSE), and right ventricular stroke work index (RVSWI).
Results
32 studies (4,756 patients) were included in this review. The incidence of RVF was found to be 27.48% (1,307 patients). The weighted mean [standard deviation (SD)] of preoperative PAPi associated with RVF versus No RVF was 2.17 [2.36] and 2.87 [3.21], respectively. When comparing LVAD recipients with RVF and No RVF, patients who developed RVF had a significantly lower preoperative PAPi by a WMD [95% CI] of -0.74 [-1.00, -0.49] (P < 0.001). The remaining variables (CVP; CVP/PCWP; TAPSE; and RVSWI) were also confirmed as predictors of RVF after LVAD implantation.
Conclusions
This systematic review demonstrates the utility of PAPi as a clinical predictor of RVF after LVAD implantation. Based on our findings, we recommend that PAPi be used in conjunction with traditional hemodynamic parameters when risk stratifying LVAD recipients for RVF.
Background:
To investigate preimplant risk factors associated with early right ventricular assist device (RVAD) use in patients undergoing continuous-flow left ventricular assist device (LVAD) surgery.
Methods and results:
Patients in the Interagency Registry for Mechanically Assisted Circulatory Support who underwent primary continuous-flow-LVAD surgery were examined for concurrent or subsequent RVAD implantation within 14 days of LVAD. Risk factors for RVAD implantation and the combined end point of RVAD or death within 14 days of LVAD were assessed with stepwise logistic regression. We compared survival between patients with and without RVAD using Kaplan-Meier method and Cox proportional hazards modeling. Of 9976 patients undergoing continuous-flow-LVAD implantation, 386 patients (3.9%) required an RVAD within 14 days of LVAD surgery. Preimplant characteristics associated with RVAD use included interagency registry for mechanically assisted circulatory support patient profiles 1 and 2, the need for preoperative extracorporeal membrane oxygenation or renal replacement therapy, severe preimplant tricuspid regurgitation, history of cardiac surgery, and concomitant procedures other than tricuspid valve repair at the time of LVAD. Hemodynamic determinants included elevated right atrial pressure, reduced pulmonary artery pulse pressure, and reduced stroke volume. The final model demonstrated good performance for both RVAD implant (area under the curve, 0.78) and the combined end point of RVAD or death within 14 days (area under the curve, 0.73). Compared with patients receiving an isolated LVAD, patients requiring RVAD had decreased 1- and 6-month survival: 78.1% versus 95.8% and 63.6% versus 87.9%, respectively (P<0.0001 for both).
Conclusions:
The need for RVAD implantation after LVAD is associated with indices of global illness severity, markers of end-organ dysfunction, and profiles of hemodynamic instability.
The aim of this study was to evaluate the incidence, risk factors, and effect on outcomes of right ventricular failure in a large population of patients implanted with continuous-flow left ventricular assist devices.
Patients (n = 484) enrolled in the HeartMate II left ventricular assist device (Thoratec, Pleasanton, Calif) bridge-to-transplantation clinical trial were examined for the occurrence of right ventricular failure. Right ventricular failure was defined as requiring a right ventricular assist device, 14 or more days of inotropic support after implantation, and/or inotropic support starting more than 14 days after implantation. Demographics, along with clinical, laboratory, and hemodynamic data, were compared between patients with and without right ventricular failure, and risk factors were identified.
Overall, 30 (6%) patients receiving left ventricular assist devices required a right ventricular assist device, 35 (7%) required extended inotropes, and 33 (7%) required late inotropes. A significantly greater percentage of patients without right ventricular failure survived to transplantation, recovery, or ongoing device support at 180 days compared with patients with right ventricular failure (89% vs 71%, P < .001). Multivariate analysis revealed that a central venous pressure/pulmonary capillary wedge pressure ratio of greater than 0.63 (odds ratio, 2.3; 95% confidence interval, 1.2-4.3; P = .009), need for preoperative ventilator support (odds ratio, 5.5; 95% confidence interval, 2.3-13.2; P < .001), and blood urea nitrogen level of greater than 39 mg/dL (odds ratio, 2.1; 95% confidence interval, 1.1-4.1; P = .02) were independent predictors of right ventricular failure after left ventricular assist device implantation.
The incidence of right ventricular failure in patients with a HeartMate II ventricular assist device is comparable or less than that of patients with pulsatile-flow devices. Its occurrence is associated with worse outcomes than seen in patients without right ventricular failure. Patients at risk for right ventricular failure might benefit from preoperative optimization of right heart function or planned biventricular support.
Patients with advanced heart failure have improved survival rates and quality of life when treated with implanted pulsatile-flow left ventricular assist devices as compared with medical therapy. New continuous-flow devices are smaller and may be more durable than the pulsatile-flow devices.
In this randomized trial, we enrolled patients with advanced heart failure who were ineligible for transplantation, in a 2:1 ratio, to undergo implantation of a continuous-flow device (134 patients) or the currently approved pulsatile-flow device (66 patients). The primary composite end point was, at 2 years, survival free from disabling stroke and reoperation to repair or replace the device. Secondary end points included survival, frequency of adverse events, the quality of life, and functional capacity.
Preoperative characteristics were similar in the two treatment groups, with a median age of 64 years (range, 26 to 81), a mean left ventricular ejection fraction of 17%, and nearly 80% of patients receiving intravenous inotropic agents. The primary composite end point was achieved in more patients with continuous-flow devices than with pulsatile-flow devices (62 of 134 [46%] vs. 7 of 66 [11%]; P<0.001; hazard ratio, 0.38; 95% confidence interval, 0.27 to 0.54; P<0.001), and patients with continuous-flow devices had superior actuarial survival rates at 2 years (58% vs. 24%, P=0.008). Adverse events and device replacements were less frequent in patients with the continuous-flow device. The quality of life and functional capacity improved significantly in both groups.
Treatment with a continuous-flow left ventricular assist device in patients with advanced heart failure significantly improved the probability of survival free from stroke and device failure at 2 years as compared with a pulsatile device. Both devices significantly improved the quality of life and functional capacity. (ClinicalTrials.gov number, NCT00121485.)
The new Advanced ventricular assist device (VAD) has many features such as improving pulsatility and preventing regurgitant flow during pump stoppage. The purpose of this study was to evaluate the effects of design modifications of the Advanced VAD on these features in vitro. Bench testing of four versions of the Advanced VAD was performed on a static or pulsatile mock loop with a pneumatic device. After pump performance was evaluated, each pump was run at 3000 rpm to evaluate pulse augmentation, then was stopped to assess regurgitant flow through the pump. There was no significant difference in pump performance between the pump models. The average pulse pressure in the pulsatile mock loop was 23.0 mm Hg, 34.0 mm Hg, 39.3 mm Hg, 33.8 mm Hg, and 37.3 mm Hg without pump, with AV010, AV020 3S, AV020 6S, and AV020 RC, respectively. The pulse augmentation factor was 48%, 71%, 47%, 62% with AV010, AV020 3S, AV020 6S, and AV020 RC, respectively. In the pump stop test, regurgitant flow was ‐0.60 ± 0.70 L/min, ‐0.13 ± 0.57 L/min, ‐0.14 ± 0.09 L/min, and ‐0.18 ± 0.06 L/min in AV010, AV020 3S, AV020 6S, AV020 RC, respectively. In conclusion, by modifying the design of the Advanced VAD, we successfully showed the improved pulsatility augmentation and regurgitant flow shut‐off features.
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Right heart failure (RHF) after left ventricular assist device (LVAD) is associated with poor outcomes. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) defines RHF as elevated right atrial pressure (RAP) plus venous congestion. The purpose of this study was to examine the diagnostic performance of the noninvasive INTERMACS criteria using RAP as the gold standard. We analyzed 108 patients with LVAD who underwent 341 right heart catheterizations (RHC) between January 1, 2006, and December 31, 2013. Physical exam, echocardiography, and laboratory data at the time of RHC were collected. Conventional two-by-two tables were used and missing data were excluded. The noninvasive INTERMACS definition of RHF is 32% sensitive (95% CI, 0.21-0.44) and 97% specific (95% CI, 0.95-0.99) for identifying elevated RAP. Clinical assessment failed to identify two-thirds of LVAD patients with RAP > 16 mm Hg. More than half of patients with elevated RAP did not have venous congestion, which may represent a physiologic opportunity to mitigate the progression of disease before end-organ damage occurs. One-quarter of patients who met the noninvasive definition of RHF did not actually have elevated RAP, potentially exposing patients to unnecessary therapies. In practice, if any component of the INTERMACS definition is present or equivocal, our data suggest RHC is warranted to establish the diagnosis.
Background:
The use of continuous flow left ventricular assist devices (CF-LVAD) to treat advanced heart failure is increasing. While risk score such as MELD and the HeartMate II Risk Score require the use of INR, many patients are on anticoagulation prior to CF-LVAD implantation. The aim of this study was to evaluate the ability of the Model of End-Stage Liver Disease-eXcluding INR (MELD-XI) scoring system to predict clinical outcomes in patients with advanced heart failure who undergo CF-LVAD implantation.
Methods:
A single-center retrospective review was performed on patients (N=524) who were implanted with the HeartMate II LVAD (HM II; Thoratec Corporation, Pleasanton, CA) or the HeartWare HVAD (HeartWare International Inc., Framingham, MA) between 2004 and 2016. Patients were stratified into two cohorts: those with a MELD-XI score <14 (n=301) and ≥14 (n=223).
Results:
Patients with the higher-risk MELD-XI score of ≥14 demonstrated lower survival rates at 1, 3, 6, 12, and 24 months (p<0.001 for all) and increased risk of early right heart failure and infections compared to patients with MELD-XI score <14. MELD-XI was not significantly inferior at predicting 90-day mortality as compared to the HeartMate II Risk Score (p=0.92). Patients with elevated MELD-XI scores at follow-up demonstrated higher rates of mortality.
Conclusions:
These findings suggest that a MELD-XI score ≥14 was associated with a higher postoperative mortality rate than that seen in patients with a lower MELD-XI score. MELD-XI scoring system can be used to predict outcomes in patients with advanced heart failure patients who undergo CF-LVAD implantation.
Background:
The pulmonary artery pulsatility index (PAPi) - defined as the ratio of pulmonary artery pulse pressure to right atrial pressure -emerged as a powerful predictor of right ventricular (RV) failure in patients with acute inferior myocardial infarction and those undergoing left ventricular assist device placement, however, its prognostic utility in the advanced heart failure population remains largely unknown.
Methods and results:
We comparatively analyzed PAPi with traditional indices of RV function including RV stroke work index (RVSWI) and right atrial /pulmonary capillary wedge pressure ratio (RAP/PCWP) in the ESCAPE trial. Median PAPi score was 2.35 in 190 patients. PAPi was significantly associated with clinical [jugular venous distention, ascites, edema], echocardiographic [right atrial size, vena cava size, tricuspid regurgitation velocity] and hemodynamic signs of RV failure [right atrial pressure, PCWP, RA/PCWP] (all p <0.05). In addition, PAPi was associated with the measures of left ventricular (LV) function, including ejection fraction, cardiac index, and PCWP (all p <0.05). In Cox regression analysis, PAPi was an independent predictor of primary end-point of death or hospitalization at 6 months (HR 0.91 [0.84 - 0.99], p = 0.022), whereas RA pressure, RVSWI or RA/PCWP were not.
Conclusions:
PAPi serves as a marker of RV dysfunction and strongly predicts adverse clinical events in patients with advanced heart failure. Incorporating PAPi into existing risk models can substantially improve patient selection for advanced therapies and clinical outcomes in this population.
Background:
Gastrointestinal bleeding (GIB) remains a major morbid event during continuous flow left ventricular assist device (LVAD) support. This study investigated whether a common hemodynamic profile is associated with GIB in patients with LVADs.
Methods and results:
A single institution analysis reviewed all patients who underwent right heart catheterization (RHC) following LVAD implant between 1/1/2006 and 12/31/2013 with follow-up through 6/2015. Kaplan-Meier and multi-phase hazard statistical methods were employed. Among 108 patients with 341 RHCs, 55 hospitalizations for GIB occurred within 1 year of RHC. Freedom from GIB at 6 months was 92% in patients with pulse pressure ≥ 35 mmHg, compared to 76% with pulse pressure < 35 mmHg. By multivariable analysis, the significant predictors of GIB were: older age at implant, number of prior GIB, lower pulse pressure, lower mean arterial pressure, and higher right atrial pressure (all p<.05). The magnitude of effect is influenced by pulse pressure.
Conclusions:
Greater pulsatility and less venous congestion, along with other factors, are associated with a lower risk for GIB. It is reasonable to adjust therapeutic strategies to target this hemodynamic profile in patients with a propensity for GIB.
There is little data outlining the use of outpatient inotropic medications in patients with existing left ventricular assist devices (LVADs). This case series explores this patient population and seeks to define the indications, complications, and safety of dual support. A retrospective chart review was conducted for all patients on LVAD and then subsequently started on home inotropes post device implant. Eight patients met inclusion criteria. The indications for inotropes were right ventricular failure, aortic insufficiency with biventricular failure, LVAD thrombosis with contraindication to device exchange, and cannula malposition with elevated pulmonary vascular resistance. Mean duration of combined support was 273±170 days. Cardiac index improved from 1.96 ± 0.24 to 2.31 ±0.35L/min/m after inotropes (p = 0.02). There was no change in hospital admissions. The most common reason for readmission was heart failure symptoms, followed by bleeding. Five patients died during the study period, one underwent heart transplant, and two remain on inotropic support. Home inotropes may be indicated in selected CF-LVAD patients with refractory right ventricular failure or impaired LVAD function. Inotropes can improve hemodynamics and provide palliation of symptoms. However, long-term inotrope use does not reduce hospital readmissions and is associated with multiple complications related to the need for an indwelling intravenous line.
Each year, the American Heart Association (AHA), in conjunction with the Centers for Disease Control and Prevention, the National Institutes of Health, and other government agencies, brings together in a single document the most up-to-date statistics related to heart disease, stroke, and the cardiovascular risk factors listed in the AHA's My Life Check - Life's Simple 7 (Figure¹), which include core health behaviors (smoking, physical activity, diet, and weight) and health factors (cholesterol, blood pressure [BP], and glucose control) that contribute to cardiovascular health. The Statistical Update represents a critical resource for the lay public, policy makers, media professionals, clinicians, healthcare administrators, researchers, health advocates, and others seeking the best available data on these factors and conditions. Cardiovascular disease (CVD) and stroke produce immense health and economic burdens in the United States and globally. The Update also presents the latest data on a range of major clinical heart and circulatory disease conditions (including stroke, congenital heart disease, rhythm disorders, subclinical atherosclerosis, coronary heart disease [CHD], heart failure [HF], valvular disease, venous disease, and peripheral artery disease) and the associated outcomes (including quality of care, procedures, and economic costs). Since 2007, the annual versions of the Statistical Update have been cited >20 000 times in the literature. From January to July 2017 alone, the 2017 Statistical Update was accessed >106 500 times. Each annual version of the Statistical Update undergoes revisions to include the newest nationally representative data, add additional relevant published scientific findings, remove older information, add new sections or chapters, and increase the number of ways to access and use the assembled information. This year-long process, which begins as soon as the previous Statistical Update is published, is performed by the AHA Statistics Committee faculty volunteers and staff and government agency partners. This year's edition includes new data on the monitoring and benefits of cardiovascular health in the population, new metrics to assess and monitor healthy diets, new information on stroke in young adults, an enhanced focus on underserved and minority populations, a substantively expanded focus on the global burden of CVD, and further evidence-based approaches to changing behaviors, implementation strategies, and implications of the AHA's 2020 Impact Goals. Below are a few highlights from this year's Update.
Background
Physical examination of jugular venous pressure is used to estimate right atrial (RA) pressure and infer left-sided filling pressure to assist volume management. Previous studies in advanced heart failure patients showed about 75% concordance between RA and pulmonary capillary wedge (PCW) pressures. We sought to determine the relationship between mean RA and mean PCW pressure and assess the clinical significance in a broad population of patients undergoing invasive right heart catheterization (RHC).
Methods
We examined 4135 RHC cases at a single academic medical center from February 2007 to December 2014, analyzing baseline variables, hemodynamic data, and in-hospital mortality.
Results
The overall Pearson correlation for mean RA and PCW pressures was 0.68 with 70% concordance between dichotomized pressures (RA ≥10 and PCW ≥22 mmHg). Results were similar in subgroups with heart failure (r = 0.67, 72%), STEMI/NSTEMI (r = 0.60, 69%), unstable angina (r = 0.78, 69%), stable/no angina (r = 0.72, 67%), and valvular disease (r = 0.61, 72%; Chi-square P = .15). Mean RA pressure was independently associated with in-hospital mortality in multivariate analysis (OR 1.12 [95% CI 1.081-1.157] per 1 mmHg increase, P < .001). The RA/PCW ratio was not independently associated with in-hospital mortality. Mean RA pressure was also weakly associated with worse renal function (rho = −0.16, P < .001).
Conclusion
In patients undergoing right catheterization for diverse indications, the mean RA and PCW pressures correlated moderately well, but there was discordance in a sizable minority, in whom assessment of left-sided filling pressures using estimated jugular venous pressure may be misleading. Elevated right atrial pressure is a marker for in-hospital mortality.
Background
The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database now includes >20,000 patients from >180 hospitals.
Methods
The eighth annual report of INTERMACS updates the first decade of patient enrollment.
Results
In the current era, >95% of implants are continuous flow devices. Overall survival continues to remain >80% at 1 year and 70% at 2 years. Review of major adverse events shows minimal advantage for patients with ambulatory heart failure pre-implant. Stroke, major infection, and continued inotrope requirement during the first 3 months have a major effect on subsequent survival.
Conclusions
Greater application of durable devices to patients with ambulatory heart failure will mandate more effective neutralization or prevention of major adverse events.
Background
Continuous-flow left ventricular assist systems increase the rate of survival among patients with advanced heart failure but are associated with the development of pump thrombosis. We investigated the effects of a new magnetically levitated centrifugal continuous-flow pump that was engineered to avert thrombosis.
Methods
We randomly assigned patients with advanced heart failure to receive either the new centrifugal continuous-flow pump or a commercially available axial continuous-flow pump. Patients could be enrolled irrespective of the intended goal of pump support (bridge to transplantation or destination therapy). The primary end point was a composite of survival free of disabling stroke (with disabling stroke indicated by a modified Rankin score >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove the device at 6 months after implantation. The trial was powered for noninferiority testing of the primary end point (noninferiority margin, −10 percentage points).
Results
Of 294 patients, 152 were assigned to the centrifugal-flow pump group and 142 to the axial-flow pump group. In the intention-to-treat population, the primary end point occurred in 131 patients (86.2%) in the centrifugal-flow pump group and in 109 (76.8%) in the axial-flow pump group (absolute difference, 9.4 percentage points; 95% lower confidence boundary, −2.1 [P<0.001 for noninferiority]; hazard ratio, 0.55; 95% confidence interval [CI], 0.32 to 0.95 [two-tailed P=0.04 for superiority]). There were no significant between-group differences in the rates of death or disabling stroke, but reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (1 [0.7%] vs. 11 [7.7%]; hazard ratio, 0.08; 95% CI, 0.01 to 0.60; P=0.002). Suspected or confirmed pump thrombosis occurred in no patients in the centrifugal-flow pump group and in 14 patients (10.1%) in the axial-flow pump group.
Conclusions
Among patients with advanced heart failure, implantation of a fully magnetically levitated centrifugal-flow pump was associated with better outcomes at 6 months than was implantation of an axial-flow pump, primarily because of the lower rate of reoperation for pump malfunction. (Funded by St. Jude Medical; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.)
Background:
Right ventricular failure (RVF) is a major cause of morbidity and mortality after left ventricular assist device (LVAD) implantation. The pulmonary artery pulsatility index (PAPi) is a novel hemodynamic index that predicts RVF in the setting of myocardial infarction, although it has not been shown to predict RVF after LVAD implantation.
Methods:
We performed a retrospective, single-center analysis to examine the utility of the PAPi in predicting RVF and RV assist device (RVAD) implantation in 85 continuous-flow LVAD recipients. We performed a multivariate logistic regression analysis incorporating previously identified predictors of RVF after LVAD placement, including clinical and echocardiographic variables, to determine the independent effect of PAPi in predicting RVF or RVAD after LVAD placement.
Results:
In this cohort, the mean PAPi was 3.4 with a standard deviation of 2.9. RVF occurred in 33% of patients, and 11% required a RVAD. Multivariate analysis, adjusting for age, blood urea nitrogen (BUN), and Interagency Registry for Mechanically Assisted Circulatory Support profile, revealed that higher PAPi was independently associated with a reduced risk of RVAD placement (odds ratio [OR], 0.30; 95% confidence interval [CI], 0.07-0.89). This relationship did not change significantly when echocardiographic measures were added to the analysis. Stratifying the analysis by the presence of inotropes during catheterization revealed that PAPi was more predictive of RVAD requirement when measured on inotropes (OR, 0.21; 95% CI, 0.02-0.97) than without (OR, 0.49; 95% CI, 0.01-1.94). Furthermore, time from catheterization to LVAD did not significantly affect the predictive value of the PAPi (maximum time, 6 months). Receiver operating characteristic curve analysis revealed that optimal sensitivity and specificity were achieved using a PAPi threshold of 2.0.
Conclusions:
In LVAD recipients, the PAPi is an independent predictor of RVF and the need for RVAD support after LVAD implantation. This index appears more predictive in patients receiving inotropes and was not affected by time from catheterization to LVAD in our cohort.
OBJECTIVES This study sought to determine whether severe right ventricular (RV) dysfunction in the pre-operative setting is associated with an increased risk of gastrointestinal bleeding (GIB) post-Left ventricular assist device (LVAD). BACKGROUND GIB is a significant complication in patients supported with continuous-flow LVADs. The impact of RV dysfunction on the risk of GIB has not been investigated. METHODS We retrospectively identified 212 patients who survived index hospitalization after implantation of HeartMate II (Thoratec Corp., Pleasanton, California) or Heartware HVAD (HeartWare Corp., Framingham, Massachusetts) from June 2009 to April 2013. Patients with severe RV dysfunction on pre-LVAD echocardiogram (n = 37) were compared to patients without severe RV dysfunction (n = 175). The primary outcome was freedom from GIB. RESULTS The majority of patients were male (79%) with a median INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile of 2 at LVAD implantation. There were no significant differences between cohorts with respect to demographics, comorbidities, device type, international normalization ratio, or aspirin strategy. During follow-up, 81 patients had GIB events: 23 of 37 (62%) in the severe RV dysfunction group versus 58 of 175 (33%) in the control group (p = 0.001). After adjustment for age and ischemic cardiomyopathy, severe RV dysfunction was associated with increased risk of GIB (hazard ratio: 1.799, 95% confidence interval: 1.089 to 2.973, p = 0.022). CONCLUSIONS In this single-center sample of patients supported with continuous-flow LVADs, severe RV dysfunction on pre-LVAD echocardiogram was associated with an increased risk of GIB. Further studies are needed to investigate possible mechanisms by which RV dysfunction increases the risk of GIB and to identify patient populations who may benefit from alterations in antithrombotic strategies. (J Am Coll Cardiol HF 2015;3:956-64) (C) 2015 by the American College of Cardiology Foundation.
Background:
Tricuspid annular (TA) dilation has been suggested as a more reliable marker of concomitant advanced right ventricular failure (RVF) than severity of tricuspid regurgitation (TR). Our objective was to examine the impact of TA dilation on occurrence of RVF and in-hospital mortality following left ventricular assist device (LVAD) implant.
Methods:
Consecutive patients undergoing implantation of a continuous-flow LVAD implant were grouped according to the presence or absence of preoperative dilated TA. Clinical characteristics, hemodynamics, and short-term postoperative outcomes were compared between groups. RVF was defined as unplanned right ventricular assist device (RVAD) or postoperative use of inotropes for >14 days. Linear and logistic regressions were used to explore associations of TA with occurrence of RVF and duration of inotrope use.
Results:
We included 69 patients who had continuous-flow LVAD implanted between 2006 and 2013 (50 ± 13 years old; 69% males; 37% ischemic etiology; 69% bridge-to-transplant LVAD; 18% INTERMACS 1-2; 48% with significant TR). RVF occurred in nine cases, and overall in-hospital mortality rate was 14%. Tricuspid valve repair was performed in ten cases. Dilated TA (OR 4.86; 95%CI 1.05-22.33; p = 0.04) was associated with RVF. In an adjusted multivariable analysis, indexed TA was an independent predictor of increased days of inotrope use (0.8-day increase in inotrope use for every 1 mm/m(2) increase; p = 0.04).
Conclusion:
In this cohort, TA dilation was a predictor of RVF after LVAD implant. The potential benefit of concomitant TVR in selected patients with a dilated TA undergoing LVAD implantation remains to be determined.
Inotropes improve symptoms in advanced heart failure (HF), but were associated with higher mortality in clinical trials. Recurrent hospitalizations, arrhythmias, and infections contribute to morbidity and mortality, but the risks of these complications with modern HF therapies are not well known. We collected arrhythmia, infection, and hospitalization data on 197 patients discharged from our institution between January 2007 and March 2013 on intravenous inotropes. Patients were followed until they died, received a transplant or left ventricular assist device, were weaned off inotropes, or remained on inotropes at the end of the study. All patients had stage D heart failure. At baseline, 30% had history of ventricular tachycardia, 7.1% had history of cardiac arrest, and 39% had a history of atrial fibrillation. During follow-up, 33 patients (17%) had one or more ICD shocks. Among patients who had shocks, 27 (82%) had appropriate shocks for VT/VF, 3 (9%) had inappropriate shocks, and 3 (9%) had both appropriate and inappropriate shocks. The risk of ICD shock was not related to dose of inotrope (p 0.605). Fifty-seven patients (29%) had one or more infection during follow-up. Bacteremia was the most common type of infection. Implanted electrophysiology devices did not confer an increased risk of infection. One hundred twelve patients (57%) had one or more hospitalization during follow-up. Common causes of hospitalizations were worsening HF symptoms (41%), infections (20%) and arrhythmias (12%). In conclusion, arrhythmias, infections, and re-hospitalizations are important complications of inotropic therapy.
The outcomes of ventricular assist device therapy remain limited by right ventricular failure. We sought to define the predictors and evaluate the outcomes of right ventricular failure requiring right ventricular assist device support after long-term continuous-flow left ventricular assist device implantation.
Records of all continuous-flow left ventricular assist device recipients for the last 10 years were analyzed, including patients on preoperative intra-aortic balloon pump, extracorporeal membrane oxygenation, and short-term ventricular assist device support. Perioperative clinical, echocardiographic, hemodynamic, and laboratory data of continuous-flow left ventricular assist device recipients requiring right ventricular assist device support (right ventricular assist device group) were compared with the rest of the patient cohort (control group).
Between July 2003 and June 2013, 152 patients underwent continuous-flow left ventricular assist device implantation as a bridge to transplantation. The overall postoperative incidence of right ventricular assist device support was 23.02% (n = 35). Right ventricular assist device implantation did not significantly affect eventual transplantation (P = .784) or longer-term survival (P = .870). Preoperative right ventricular diameter (P < .001), tricuspid annular plane systolic excursion (P < .001), previous sternotomy (P = .002), preoperative short-term mechanical support (P = .005), left atrial diameter (P = .014), female gender (P = .020), age (P = .027), and preoperative bilirubin levels (P = .031) were univariate predictors of right ventricular assist device implantation. Multivariate analysis revealed lesser tricuspid annular plane systolic excursion (P = .013; odds ratio, 0.613; 95% confidence interval, 0.417-0.901) and smaller left atrial diameter (P = .007; odds ratio, 0.818; 95% confidence interval, 0.707-0.947) as independent predictors of right ventricular assist device implantation. Receiver operating characteristic curve of tricuspid annular plane systolic excursion yielded an area under the curve of 0.85 (95% confidence interval, 0.781-0.923), with cutoff tricuspid annular plane systolic excursion less than 12.5 mm having 84% sensitivity and 75% specificity.
Lesser tricuspid annular plane systolic excursion and smaller left atrial diameter are independent predictors of the need for right ventricular assist device support after continuous-flow left ventricular assist device implantation. Right ventricular assist device implantation does not adversely affect eventual transplantation or survival after continuous-flow left ventricular assist device implantation.
Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
To assess the impact of random left truncation of data on the estimation of time-dependent exposure effects.
A simulation study was conducted in which the relation between exposure and outcome was based on an immediate exposure effect, a first-time exposure effect, or a cumulative exposure effect. The individual probability of truncation, the moment of truncation, the exposure rate, and the incidence rate of the outcome were varied in different simulations. All observations before the moment of left truncation were omitted from the analysis.
Random left truncation did not bias estimates of immediate exposure effects, but resulted in an overestimation of a cumulative exposure effect and underestimation of a first-time exposure effect. The magnitude of bias in estimation of cumulative exposure effects depends on a combination of exposure rate, probability of truncation, and proportion of follow-up time left truncated.
In case of a cumulative or first-time exposure, left truncation can result in substantial bias in pharmacoepidemiologic studies. The potential for this bias likely differs between databases, which may lead to heterogeneity in estimated exposure effects between studies.
Copyright © 2015 Elsevier Inc. All rights reserved.
Objectives:
A post-approval (PA) study for destination therapy (DT) was required by the Food and Drug Administration (FDA) to determine whether results with the HeartMate (HM) II (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial.
Background:
New device technology developed in the clinical research setting requires validation in a real-world setting.
Methods:
The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry. Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years. A historical comparison group included patients (n = 133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR). Survival rates and adverse events for the PA group were obtained from the INTERMACS registry.
Results:
Baseline characteristics were similar for PA versus TR. Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28% were in profile 3. Adverse events in the PA group were similar or lower than those in the TR group, including improvements in device-related infection (0.22 vs. 0.47) and post-operative bleeding requiring surgery (0.09 vs. 0.23) events per patient-year. Kaplan-Meier survival at 2 years was 62% (PA group) versus 58% (TR group). PA group survival at 1 and 2 years was 82 ± 5% and 69 ± 6% for INTERMACS profiles 4 to 7 (n = 63) versus 72 ± 3% and 60 ± 4% for profiles 1 to 3 (n = 184). The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group.
Conclusions:
Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD. Survival was best in patients who were not inotrope-dependent (INTERMACS profiles 4 to 7).
Background:
Management of right ventricular (RV) failure after left ventricular assist device (LVAD) implantation is not evidence based. Temporary circulatory assistance has recently been reported to be of value for managing postoperative RV failure after LVAD implantation, but only in small series of patients or isolated case reports. We report here our experience with the use of temporary right ventricular assist devices (RVADs) in LVAD recipients.
Methods:
Forty-five of the 488 (9%) patients undergoing LVAD implantation between 2001 and 2011 at the Clinic for Thoracic and Cardiovascular Surgery in Bad Oeynhausen had RV failure requiring temporary RVAD. We analyzed preoperative data, complications, mortality at 6 months, and risk factors of death.
Results:
The LVAD patients receiving temporary RVAD were younger than the 443 recipients of LVAD alone. They were more likely to have mechanical ventilation and haemofiltration and their Michigan right ventricular risk score was higher. The LVAD patients with temporary RVAD had a higher mortality at 6 months: 53%, versus 25% for patients receiving LVAD only (P < .001). The univariate risk factors for death were high blood urea nitrogen and C-reactive protein concentrations, preoperative mechanical ventilation, preoperative hemofiltration, destination therapy, the use of temporary RVAD, and the development of RV failure. Multivariate analyses did not identify predictors of death.
Conclusions:
The development of RV failure in LVAD recipients is a serious problem associated with high mortality. Temporary RV mechanical support is an acceptable way to manage postoperative RV failure in these severely ill LVAD recipients.
CO-CHAIRS: Feldman D: Minneapolis Heart Institute, Minneapolis, Minnesota, Georgia Institute of Technology and Morehouse School of Medicine; Pamboukian SV: University of Alabama at Birmingham, Birmingham, Alabama; Teuteberg JJ: University of Pittsburgh, Pittsburgh, Pennsylvania TASK FORCE CHAIRS: Birks E: University of Louisville, Louisville, Kentucky; Lietz K: Loyola University, Chicago, Maywood, Illinois; Moore SA: Massachusetts General Hospital, Boston, Massachusetts; Morgan JA: Henry Ford Hospital, Detroit, Michigan CONTRIBUTING WRITERS: Arabia F: Mayo Clinic Arizona, Phoenix, Arizona; Bauman ME: University of Alberta, Alberta, Canada; Buchholz HW: University of Alberta, Stollery Children's Hospital and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada; Deng M: University of California at Los Angeles, Los Angeles, California; Dickstein ML: Columbia University, New York, New York; El-Banayosy A: Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania; Elliot T: Inova Fairfax, Falls Church, Virginia; Goldstein DJ: Montefiore Medical Center, New York, New York; Grady KL: Northwestern University, Chicago, Illinois; Jones K: Alfred Hospital, Melbourne, Australia; Hryniewicz K: Minneapolis Heart Institute, Minneapolis, Minnesota; John R: University of Minnesota, Minneapolis, Minnesota; Kaan A: St. Paul's Hospital, Vancouver, British Columbia, Canada; Kusne S: Mayo Clinic Arizona, Phoenix, Arizona; Loebe M: Methodist Hospital, Houston, Texas; Massicotte P: University of Alberta, Stollery Children's Hospital, Edmonton, Alberta, Canada; Moazami N: Minneapolis Heart Institute, Minneapolis, Minnesota; Mohacsi P: University Hospital, Bern, Switzerland; Mooney M: Sentara Norfolk, Virginia Beach, Virginia; Nelson T: Mayo Clinic Arizona, Phoenix, Arizona; Pagani F: University of Michigan, Ann Arbor, Michigan; Perry W: Integris Baptist Health Care, Oklahoma City, Oklahoma; Potapov EV: Deutsches Herzzentrum Berlin, Berlin, Germany; Rame JE: University of Pennsylvania, Philadelphia, Pennsylvania; Russell SD: Johns Hopkins, Baltimore, Maryland; Sorensen EN: University of Maryland, Baltimore, Maryland; Sun B: Minneapolis Heart Institute, Minneapolis, Minnesota; Strueber M: Hannover Medical School, Hanover, Germany INDEPENDENT REVIEWERS: Mangi AA: Yale University School of Medicine, New Haven, Connecticut; Petty MG: University of Minnesota Medical Center, Fairview, Minneapolis, Minnesota; Rogers J: Duke University Medical Center, Durham, North Carolina.
Right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation results in significant morbidity and mortality. Preoperative parameters from transthoracic echocardiography (TTE) that predict RVF after LVAD implantation might identify patients in need of temporary or permanent right ventricular (RV) mechanical or inotropic support.
Records of all patients who had preoperative TTE before implantation of a permanent LVAD at our institution from 2008 to 2011 were screened, and 55 patients (age 54 ± 16 years, 71% male) were included: 26 had LVAD implantation alone with no postoperative RVF, 16 had LVAD implantation alone but experienced postoperative RVF, and 13 had initial biventricular assist devices (BIVADs). The LVAD with RVF and BIVAD groups (RVF group) were pooled for comparison with the LVAD patients without RVF (No RVF group). RV fractional area change (RV FAC) was significantly lower in the RVF group versus the No RVF group (24% vs 30%; P = .04). Tricuspid annular plane systolic excursion was not different among the groups (1.6 cm vs 1.5 cm; P = .53). Estimated right atrial pressure (RAP) was significantly higher in the RVF group versus the No RVF group (11 mm Hg vs 8 mm Hg; P = .04). Left atrial volume (LAV) index was lower in patients with RVF versus No RVF (27 mL/m(2) vs 40 mL/m(2); P = .008). Combining RV FAC, estimated RAP, and LAV index into an echocardiographic scoring system revealed that the TTE score was highly predictive of RVF (5.0 vs 2.8; P = .0001). In multivariate models combining the TTE score with clinical variables, the score was the most predictive of RVF (odds ratio 1.66, 95% confidence interval 1.06-2.62).
Preoperative RV FAC, estimated RAP, and LAV index predict postoperative RVF in patients undergoing LVAD implantation. These parameters may be combined into a simple echocardiographic scoring system to provide an additional tool to risk-stratify patients being evaluated for LVAD implantation.
Right ventricular failure (RVF) complicates 20-50% of left ventricular assist device (LVAD) implantation cases and contributes to increased postoperative morbidity and mortality. Normal LVAD function alters the highly compliant right ventricular (RV) physiology, which may unmask RVF. Risk scores for predicting RVF post-LVAD incorporate multiple risk factors but have not been prospectively validated. Prevention of RVF consists of optimising RV function by modifying RV preload and afterload, providing adequate intra-operative RV protection and minimising blood transfusions. Treatment of RVF relies on inotropic support, decreasing pulmonary vascular resistance and adjusting LVAD flows to minimise distortion of RV geometry. RVAD insertion is a last recourse when RVF is refractory to medical treatment.
Liver dysfunction increases post-surgical morbidity and mortality. The Model of End-stage Liver Disease (MELD) estimates liver function but can be inaccurate in patients receiving oral anti-coagulation. We evaluated the effect of liver dysfunction on outcomes after ventricular assist device (VAD) implantation and the dynamic changes in liver dysfunction that occur during VAD support.
We retrospectively analyzed 255 patients (147 with pulsatile devices and 108 with continuous-flow devices) who received a long-term VAD between 2000 and 2010. Liver dysfunction was estimated by MELD and MELD-eXcluding INR (MELD-XI), with patients grouped by a score of ≥ 17 or < 17. Primary outcomes were on-VAD, after transplant, and overall survival.
MELD and MELD-XI correlated highly (R ≥ 0.901, p < 0.0001) in patients not on oral anti-coagulation. Patients with MELD or MELD-XI < 17 had improved on-VAD and overall survival (p < 0.05) with a higher predictive power for MELD-XI. During VAD support, cholestasis initially worsened but eventually improved. Patients with pre-VAD liver dysfunction who survived to transplant had lower post-transplant survival (p = 0.0193). However, if MELD-XI normalized during VAD support, post-transplant survival improved and was similar to that of patients with low MELD-XI scores.
MELD-XI is a viable alternative for assessing liver dysfunction in heart failure patients on oral anti-coagulation. Liver dysfunction is associated with worse survival. However, if MELD-XI improves during VAD support, post-transplant survival is similar to those without prior liver dysfunction, suggesting an important prognostic role. We also found evidence of a transient cholestatic state after LVAD implantation that deserves further examination.
This study determined predictors of early post-operative right heart failure (RHF) and its consequences, as well as predictors of those who clinically thrive longer term after insertion of a continuous-flow left ventricular assist device (LVAD).
Pre-operative and latest follow-up data were analyzed for 40 consecutive patients who received third-generation centrifugal-flow LVADs. RHF was defined using previously described criteria, including post-operative inotropes, pulmonary vasodilator use, or right-sided mechanical support. Patients were also categorized according to clinical outcomes after LVAD insertion.
LVADs were implanted as a bridge to transplantation (BTT) in 33 patients and as destination therapy in 7. Before LVAD implant, 22 patients were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level 1, and 17 were at level 2. Temporary mechanical assistance was present in 50% of the cohort at LVAD implantation. The 6-month survival/progression to transplant was 92.5%. Average LVAD support time was 385 days (range, 21-1,011 days). RHF developed postoperatively in 13 of 40 patients (32.5%). RHF patients had more severe pre-operative tricuspid incompetence than non-RHF patients. The BTT patients with evidence of RHF had poorer survival to transplant (6 of 11 [54.5%]) than those without RHF (20 of 22 [90.9%]), p = 0.027). There were no other hemodynamic or echocardiographic predictors of short-term RHF. After LVAD, 22 of the 40 patients (55%) thrived clinically. For BTT patients, 20 of 21 (95%) of those who thrived progressed to transplant or were alive at latest follow-up vs 6 of 12 (50%) of those who failed to thrive (FTT; p < 0.005). The thrivers had lower New York Heart Association class (1.5 vs 2.9, p < 0.001), spent less time in the hospital, and had less ventricular tachycardia than the FTT patients. However, no differences were noted in pre-operative INTERMACS level, echocardiographic, hemodynamic, and biochemical indices, or in early post-operative RHF. Age was the only significant predictor: the thrivers were significantly younger (43.7 ± 15.9 vs 60.3 ± 12.6 years; p < 0.001). This age difference was unchanged after exclusion of destination strategy patients. RV function deteriorated in the FTT patients and remained stable in those who thrived.
Early post-operative RHF results in poorer survival/progression to transplantation for BTT patients and is predicted by greater pre-operative tricuspid incompetence. The most important predictor for those who will clinically thrive longer-term after LVAD insertion is younger age.
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.
It is generally accepted that patients who require biventricular assist device support have poorer outcomes than those requiring isolated left ventricular assist device support. However, it is unknown how the timing of biventricular assist device insertion affects outcomes. We hypothesized that planned biventricular assist device insertion improves survival compared with delayed conversion of left ventricular assist device support to biventricular assist device support.
We reviewed and compared outcomes of 266 patients undergoing left ventricular assist device or biventricular assist device placement at the University of Pennsylvania from April 1995 to June 2007. We subdivided patients receiving biventricular assist devices into planned biventricular assist device (P-BiVAD) and delayed biventricular assist device (D-BiVAD) groups based on the timing of right ventricular assist device insertion. We defined the D-BiVAD group as any failure of isolated left ventricular assist device support.
Of 266 patients who received left ventricular assist devices, 99 (37%) required biventricular assist device support. We compared preoperative characteristics, successful bridging to transplantation, survival to hospital discharge, and Kaplan-Meier 1-year survival between the P-BiVAD (n = 71) and D-BiVAD (n = 28) groups. Preoperative comparison showed that patients who ultimately require biventricular support have similar preoperative status. Left ventricular assist device (n = 167) outcomes in all categories exceeded both P-BiVAD and D-BiVAD group outcomes. Furthermore, patients in the P-BiVAD group had superior survival to discharge than patients in the D-BiVAD group (51% vs 29%, P < .05). One-year and long-term Kaplan-Meier survival distribution confirmed this finding. There was also a trend toward improved bridging to transplantation in the P-BiVAD (n = 55) versus D-BiVAD (n = 22) groups (65% vs 45%, P = .10).
When patients at high risk for failure of isolated left ventricular assist device support are identified, proceeding directly to biventricular assist device implantation is advised because early institution of biventricular support results in dramatic improvement in survival.
Because duration of inotropic support after left ventricular assist device implantation has been recognized as a surrogate for right ventricular dysfunction, we sought to (1) identify its preimplantation risk factors, particularly its association with preimplantation right ventricular dysfunction, and (2) assess its impact on clinical outcomes.
Between 1991 and 2002, left ventricular assist devices were implanted in 207 patients, exclusive of those receiving preoperative mechanical circulatory support, which precluded measuring right ventricular stroke work. Duration of inotropic support was analyzed as a continuous variable, truncated by death or transplantation, and in turn as a risk factor for these 2 events.
Inotropic support decreased from 100% on the day of implantation to 57%, 33%, and 22% by days 7, 14, and 21. Its duration was strongly associated with lower preimplantation right ventricular stroke work index, older age, and nonischemic cardiomyopathy and was associated (P < .04) with higher mortality before transplantation but not with transition to transplantation. We identified no preimplantation risk factors for right ventricular assist device use because of its relatively infrequent use in this population (18 patients, only 4 of whom survived to transplantation).
Duration of inotropic support after left ventricular assist device insertion is strongly correlated with low preimplantation right ventricular stroke work index. In turn, it was associated with reduced survival to transplantation. Thus, right ventricular stroke work measured before implantation might be useful in decision making for biventricular support, destination therapy, or total artificial heart.
The purpose of this study was to evaluate the incidence and prognostic implication of diastolic dysfunction (DD) occurring in the first year after transplant.
Diastolic dysfunction is a recognized complication in heart transplant recipients, but its true incidence and natural history has been poorly characterized. We studied the prognostic implication of DD, as defined by elevated filling pressures with normal systolic function, occurring in the first year after transplant.
Between June 1992 and June 2002, all patients who underwent heart transplantation at a single institution were included in the study (231 at 6 weeks and 250 at 6 months and 1 year). Diastolic dysfunction was defined as right atrial pressure (RAP) >/=15 mm Hg (right ventricular [RV] DD) or pulmonary capillary wedge pressure >/=18 mm Hg (left ventricular [LV] DD) with normal systolic function by echocardiogram and without severe mitral or tricuspid insufficiency. In addition, RV DD was defined by a RAP/stroke volume (SV) ratio.
The incidence of DD was 22%, 8%, and 12% at 6 weeks, 6 months, and 1 year, respectively. The incidence of LV DD was more frequent than that of RV DD at any time point (p < 0.0001). By multivariable analysis RV DD, as manifested by an elevated RAP/SV, but not LV DD was a strong predictor of cardiac mortality at all time points.
Diastolic dysfunction is common early after transplant, and its incidence decreases during the first year. Right ventricular DD, as measured by an elevated RAP/SV ratio, but not LV DD is a strong predictor of cardiac mortality. Further studies are needed to evaluate the functional status of patients with RV or LV DD and whether aggressive medical therapy for early DD could alter outcome.