The incidence, risk factors, and outcomes associated with late right-sided heart failure in patients supported with an axial-flow left ventricular assist device

doi:10.1016/j.healun.2016.08.010

The Journal of Heart and Lung Transplantation

Volume 36, Issue 1, January 2017, Pages 50-58

https://doi.org/10.1016/j.healun.2016.08.010 Get rights and content

Background

Early right-sided heart failure (RHF) after left ventricular assist device (LVAD) implantation is associated with increased mortality, but little is known about patients who develop late RHF (LRHF). We evaluated the incidence, risk factors, and clinical impact of LRHF in patients supported by axial-flow LVADs.

Methods

Data were analyzed from 537 patients enrolled in the HeartMate II (HM II; Thoratec/St. Jude) destination therapy clinical trial. LRHF was defined as the development of clinical RHF accompanied by the need for inotropic support occurring more than 30 days after discharge from the index LVAD implant hospitalization. Clinical variables, quality of life, rehospitalizations, and survival were compared between patients with and without LRHF.

Results

LRHF developed in 41 patients (8%), with a median time to LRHF of 480 days. A higher preoperative blood urea nitrogen and increased central venous pressure–to–pulmonary capillary wedge pressure ratio were independent predictors of LRHF. The Michigan and HMII RHF risk scores were both associated with an increased likelihood of LRHF (p < 0.05). Patients with LRHF had worse quality of life according to the Kansas City Cardiomyopathy Questionnaire (61 ± 26 vs 70 ± 21; p < 0.05), poorer functional capacity by 6-minute walk distance (275 ± 189 m vs 312 ± 216 m; p < 0.05), and more rehospitalizations (6 vs 3; p < 0.001). LRHF was associated with decreased survival (p < 0.001).

Conclusions

LRHF is an important complication in patients with LVADs and is associated with worse quality of life, reduced functional capacity, more frequent hospitalizations, and worse survival compared with those without LRHF.

Section snippets

Study design and definitions

The data from this study were derived and analyzed from the prospective, multicenter HeartMate II DT clinical trial conducted across 38 United States centers.³ Detailed inclusion and exclusion criteria for the trial have been previously reported.³ The primary focus of this study was to define and better understand the features, risk factors, and outcomes associated with the clinical complication of LRHF in the LVAD-supported patient compared with those patients who do not develop ERHF or LRHF.

Results

The study cohort consisted of 537 patients (77% male) with a mean duration of support of 2.4 ± 1.5 years. There was no difference in days on LVAD support between those with LRHF and those with no RHF (834 ± 495 vs 895 ± 569 days; p = 0.64). Patients were a mean age of 63 ± 12 years, and the HF etiology was an ischemic cardiomyopathy in 59%. Pre-implant hemodynamic support included 77% of patients on inotropes and 19% supported by an intra-aortic balloon pump. Key baseline clinical

Discussion

Major findings in this study of more than 500 patients receiving an axial-flow LVAD as DT include:

1.
Nearly 10% of patients will develop LRHF severe enough to require rehospitalization and initiation of inotropes.
2.
LRHF is associated with considerable morbidity, including lower QOL, worse exercise capacity, and more frequent rehospitalizations of prolonged durations.
3.
LRHF is associated with reduced survival, worse even than those who develop ERHF after LVAD implant in those who survive to hospital

Conclusions

This is the largest study to date to evaluate the clinically relevant complication of LRHF during LVAD support. LRHF is associated with significant morbidity highlighted by its association with recurrent hospitalizations, reduced QOL, and impaired exercise capacity. LRHF is also associated with reduced long-term survival. Optimal strategies to prevent and treat LRHF remain unclear at this time and underscore the need for future studies to directly address this complication.

Disclosure statement

J.D.R. has served as a consultant for HeartWare. C.P. has served as a consultant for HeartWare and Thoratec/St. Jude. S.J. has received speaker honoraria from Thoratec/St Jude. J.K. has received research support from Thoratec/St. Jude. P.E. has served as a consultant for Thoratec/St. Jude. K.S. is an employee of Thoratec/St. Jude. B.B. has served as a consultant for Medtronic. N.U. has served as a consultant for HeartWare, Thoratec/St. Jude, and Abiomed. M.K. has received research support from

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Detecting right heart failure post left ventricular assist device (LVAD) is challenging. Sensitive pressure-volume loop assessments of right ventricle (RV) contractility may improve our appreciation of post-LVAD RV dysfunction.
Thirteen LVAD patients and 20 reference (non-LVAD) subjects underwent comparison of echocardiographic, right heart cath hemodynamic, and pressure-volume loop-derived assessments of RV contractility using end-systolic elastance (Ees), RV afterload by effective arterial elastance (Ea), and RV-pulmonary arterial coupling (ratio of Ees/Ea).
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LVAD patients demonstrate occult intrinsic RV dysfunction. In the setting of excess RV afterload, LVAD patients lack the RV contractile reserve to maintain ventriculo-vascular coupling. Depression in RV contractility may be related to LVAD left ventricular unloading, which reduces septal contractility.
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This comprehensive review highlights the significant advancements in Left Ventricular Assist Device (LVAD) therapy, emphasizing its evolution from the early pulsatile flow systems to the cutting-edge continuous-flow devices, particularly the HeartMate 3 (HM3) LVAD. These advancements have notably improved survival rates, reduced complications, and enhanced the quality of life (QoL) for patients with advanced heart failure. The dual role of LVADs, as a bridge-to-transplantation and destination therapy is discussed, highlighting the changing trends and policies in their application. The marked reduction in hemocompatibility-related adverse events (HRAE) with the HM3 LVAD, compared to previous models signifies ongoing progress in the field. Challenges such as managing major infections are discussed, including innovative solutions like energy transfer systems aimed at eliminating external drivelines. It explores various LVAD-associated complications, including HRAE, infections, hemodynamic-related adverse events, and cardiac arrhythmias, and underscores emerging strategies for predicting post-implantation outcomes, fostering a more individualized patient care approach. Tools such as the HM3 risk score are introduced for predicting survival based on pre-implant factors, along with advanced imaging techniques for improved complication prediction. Additionally, the review highlights potential new technologies and therapies in LVAD management, such as hemodynamic ramp tests for optimal speed adjustment and advanced remote monitoring systems. The goal is to automate LVAD speed adjustments based on real-time hemodynamic measurements, indicating a shift towards more effective, patient-centered therapy. The review concludes optimistically that ongoing research and potential future innovations hold the promise of revolutionizing heart failure management, paving the way for more effective and personalized treatment modalities.
Systematic Review of the Use of the 6-Minute Walk Test in Measuring and Improving Prognosis in Patients With Ischemic Heart Disease
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The 6-minute walk test (6MWT) has been used for over 30 years to assess exercise capacity in patients with respiratory disease, and more recently, in those with heart failure. However, despite being a simple and reproducible test of real-world exercise capacity, its use in patients with ischemic heart disease (IHD) is less well accepted. We sought to review systematically the evidence surrounding the 6MWT in IHD.
We searched the Medline, PubMed, Embase, and Scopus databases for the following key terms: “six minute walk test/6 minute walk test/6MWT” and “angina/coronary artery disease/coronary disease/IHD/ischemic heart disease.” We followed Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines to select publications for full-text review and analyzed the collated data.
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The 6MWT has been studied inconsistently in IHD. The majority of data are on patients before and after CR. Data are limited concerning the effect on 6MWTd of OHS or PCI. The available data support the 6MWT as a measure of change in performance status following coronary intervention. More work is required to confirm this hypothesis.
Le test de marche de 6 minutes (TM6) est utilisé depuis plus de 30 ans pour évaluer la tolérance à l’effort chez les patients atteints de maladies respiratoires, et maintenant également utilisé auprès des patients atteints d’insuffisance cardiaque. Toutefois, bien qu’il s’agisse d’un test simple et facile à reproduire de la tolérance à l’effort en contexte réel, son utilisation est moins bien acceptée auprès des patients présentant une cardiopathie ischémique (CI). Notre objectif était de réaliser une revue systématique des données probantes au sujet du TM6 chez les patients atteints de CI.
Nous avons effectué une recherche dans les bases de données Medline, PubMed, Embase et Scopus en utilisant les mots-clés suivants : « six minute walk test/6 minute walk test/6MWT » [test de marche de six minutes/test de marche de 6 minutes/TM6] et « angina/coronary artery disease/coronary disease/IHD/ischemic heart disease » [angine/coronaropathie/CI/cardiopathie ischémique]. Nous avons suivi les lignes directrices « Preferred Reporting Items for Systematic Reviews and Meta-analysis » pour sélectionner les articles à soumettre à un examen du texte intégral et nous avons analysé les données obtenues.
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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.
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The medical management of patients supported with durable continuous flow left ventricular assist device (LVAD) support encompasses pharmacological therapies administered in the preoperative, intraoperative, postoperative, and chronic LVAD support stages. As patients live longer on LVAD support, the risks of LVAD-related complications and progression of cardiovascular and other diseases increase. Using existing data from cohort studies, registries, randomized trials, and expert opinion, this Heart Failure Society of America Consensus Document on the Medical Management of Patients on Durable Mechanical Circulatory Support offers best practices on the management of patients on durable mechanical circulatory support, focusing on pharmacological therapies administered to patients on continuous flow LVADs. Although quality data in the LVAD population are few, the use of guideline-directed heart failure medical therapies and the importance of blood pressure management, right ventricular preload and afterload optimization, and antiplatelet and anticoagulation regimens are discussed. Recommended pharmacological regimens used to mitigate or treat common complications encountered during LVAD support, including arrhythmias, vasoplegia, mucocutaneous bleeding, and infectious complications, are addressed. Finally, this document touches on important potential pharmacological interactions from antidepressants and herbal and nutritional supplements of relevance to providers of patients on LVAD support.

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The incidence, risk factors, and outcomes associated with late right-sided heart failure in patients supported with an axial-flow left ventricular assist device

Background

Methods

Results

Conclusions

Section snippets

Study design and definitions

Results

Discussion

Conclusions

Disclosure statement

Cardiol Clin

J Thorac Cardiovasc Surg

J Am Coll Cardiol

J Heart Lung Transplant

J Heart Lung Transplant

J Am Soc Echocardiogr

J Heart Lung Transplant

J Heart Lung Transplant

Ann Thorac Surg

J Heart Lung Transplant

JACC Heart Fail

J Card Fail

J Thorac Cardiovasc Surg

J Am Coll Cardiol

J Card Fail