Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients The ROADMAP Study 2-Year Results

OBJECTIVES The authors sought to provide the pre-specified primary endpoint of the ROADMAP (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) trial at 2 years. BACKGROUND The ROADMAP trial was a prospective nonrandomized observational study of 200 patients (97 with a left ventricular assist device [LVAD], 103 on optimal medical management [OMM]) that showed that survival with improved functional status at 1 year was better with LVADs compared with OMM in a patient population of ambulatory New York Heart Association functional class IIIb/IV patients. METHODS The primary composite endpoint was survival on original therapy with improvement in 6-min walk distance \u3e= 75 m. RESULTS Patients receiving LVAD versus OMM had lower baseline health-related quality of life, reduced Seattle Heart Failure Model 1-year survival (78% vs. 84%; p = 0.012), and were predominantly INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile 4 (65% vs. 34%; p \u3c 0.001) versus profiles 5 to 7. More LVAD patients met the primary endpoint at 2 years: 30% LVAD versus 12% OMM (odds ratio: 3.2 [95% confidence interval: 1.3 to 7.7]; p = 0.012). Survival as treated on original therapy at 2 years was greater for LVAD versus OMM (70 +/- 5% vs. 41 +/- 5%; p \u3c 0.001), but there was no difference in intent-to-treat survival (70 +/- 5% vs. 63 +/- 5%; p = 0.307). In the OMM arm, 23 of 103 (22%) received delayed LVADs (18 within 12 months; 5 from 12 to 24 months). LVAD adverse events declined after year 1 for bleeding (primarily gastrointestinal) and arrhythmias. CONCLUSIONS Survival on original therapy with improvement in 6-min walk distance was superior with LVAD compared with OMM at 2 years. Reduction in key adverse events beyond 1 year was observed in the LVAD group. The ROADMAP trial provides risk-benefit information to guide patient- and physician-shared decision making for elective LVAD therapy as a treatment for heart failure. (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients [ROADMAP]; NCT01452802

Ventricular assist device for advanced heart failure

Heart failure (HF) continues to be a highly prevalent disease, affecting 1–2% of the population in developed countries, therefore constitutes a health problem due to its high cost. Despite the progress made in drug treatment and implantation devices, the prognosis is poor. About 5% of patients diagnosed with heart failure are in advanced stage or stage D. Heart transplantation (HT) has become the preferred treatment for this high-risk group in the past 30 years. Unfortunately, in addition to the limitation of the current shortage of donors, there is only a limited number of patients meet the appropriate age and with the absence of comorbidities necessary to access this treatment. Due to this and the long waiting lists worldwide, the development and use of ventricular assist devices (VAD) are increasing. In view of the quality of life of patients with this serious disease, these devices improve the short-term and long-term survival rate and gradually reduce the complication rate. These benefits not only provide a choice for patients waiting for HT, but also give those with reversible contraindications the time and opportunity to become suitable candidates or, if impossible, eventually use it as a target treatment. However, these devices have many limitations: their cost, durability, incidence of complications and their limited application. Technological advances in mitigating complications, increased experience in management centers and their promotion to reduce costs are strategies that will continue to strengthen the use of VAD in patients with advanced heart failure

Evaluation of a new approach to the management of advanced chronic heart failure: use of implantable left ventricular assist devices as a bridge to heart transplantation in the UK

Introduction: Heart Transplantation (HTx) remains the standard treatment for patients with advanced chronic heart failure (ACHF). Over the last 20 years, despite rising donor numbers, practitioners have observed a decline in the numbers of adult HTx in the UK. Due to this decline and due to increasing waiting times for HTx more patients are requiring a ventricular assist device (VAD) as a bridge to heart transplantation (BTT). This work aims to evaluate VAD practice in the UK and to describe outcomes, which include survival and quality of life. Methods: A national audit study was undertaken to collect VAD data. The data was recorded in a database and analysed. An audit of quality of life was also undertaken and all adult HTx centres participated. Quality of life (QoL) data was collected from patients who were being medically treated for ACHF; patients who had received a VAD and patients who had received a heart transplant. Results: 247 patients received VADs within the study period. The use of 3rd-gen devices increased over time. The median duration of support increased from 141 days (interquartile range 80 to 253 days) to 578 days (lower quartile 204 days). Survival improved with device generation (p=0.003). At 1-year, 50.0% of patients receiving a 1st generation device were alive (95% CI 34.9 to 63.3%) compared to 76.9% of patients receiving a 3rd generation device (95%CI 68.0 to 83.6%). 386 patients completed QoL questionnaires. Patients after HTx reported the best QoL; patients with LVADs reported better QoL scores than patients being assessed for HTx and patients listed for HTx on medical therapy. Conclusions: VAD implantation has improved and increased, and has become a credible option for some patients awaiting HTx. Quality of life for patients with VADs is better than patients being treated with maximal medical therapyOpen Acces

Standardizing Initial Inpatient Palliative Care Consultations for Patients Receiving Left Ventricular Assist Devices at a Large Urban Hospital

For patients with advanced heart failure (HF) ineligible for or awaiting heart transplantation, left ventricular assist device (LVAD) implantation can be considered. LVADs have helped to improve recipients’ survival rates and quality of life. However, LVAD patients are at risk for complications such as stroke, bleeding, infection, and right ventricular failure. Moreover, events such as end-stage malignancy or progression of a neurodegenerative disorder may occur. Such complications and repeated hospitalizations can pose questions about the acceptability of LVAD therapy. As such, both the Centers for Medicare and Medicaid Services and The Joint Commission require that palliative care (PC) be part of the multidisciplinary team prior to and following VAD placement. However, execution of this mandate is unclear, leaving specifics up to the discretion of individual healthcare facilities. At our facility, all patients being evaluated for LVAD implantation must receive a PC consultation. However, confusion around the objectives and structure of this consultation persists. Therefore, the purpose of this project was to implement an evidence-based, semi-structured script to guide pre-LVAD PC consultations. Training on the script was provided to PC clinicians, and pre- and post-surveys helped to identify whether this script improved confidence in PC clinicians conducting pre-LVAD consultations. Confidence levels remained generally unchanged. However, valuable insight was gained through written feedback. Namely, clinicians felt the script provided structure and guidance but that script verbiage and flow could be improved. Moreover, clinicians expressed that communication from the HF team and a standardized workflow between PC and HF teams would be beneficial

Current state-of-the-art of device therapy for advanced heart failure

Heart failure remains one of the most common causes of morbidity and mortality worldwide. The advent of mechanical circulatory support devices has allowed significant improvements in patient survival and quality of life for those with advanced or end-stage heart failure. We provide a general overview of past and current mechanical circulatory support devices encompassing options for both short- and long-term ventricular support

What Did We Learn about VADs in 2021?

This is our 8th annual literature review on mechanical circulatory support (MCS) devices. Our previous reports were well received by the readers. The full text of the reviews for 2014, 2015, 2016, 2017, 2018, 2019, and 20201-7 were downloaded 821, 861, 701, 869, 951, 272, and 365 times, respectively. In this review, we summarized the most interesting and important, from our standpoint, publications from 2021. There may be some slight overlap with the end of 2020 because some papers were published online first, and the year of the publication changed when they became available in print. For the fifth time, we added a section on extracorporeal membrane oxygenation (ECMO), which primarily addresses new developments in veno-arterial ECMO. Readers who wish to supplement this review, argue with the author’s statements, or express their opinions are encouraged to do so by sending letters to the editor at [email protected] or posting on our Facebook page at https://www.facebook.com/TheVADJournal

What Did We Learn about VADs in 2018?

This is our 6th annual literature review on mechanical circulatory support (MCS) devices. Our previous reports for 2014, 2015, 2016, 2017, 2018 were published as open access articles and were well received by the readers. In this paper, we summarize the most interesting and important, from our standpoint, publications from 2019. As we have done for the past two years, a section on extracorporeal membrane oxygenation (ECMO) is included and primarily addresses new developments in veno-arterial ECMO use

Heart Transplantation in the Era of the Left Ventricular Assist Devices

Orthotopic heart transplant is recognized as the gold standard for the treatment of end-stage heart disease. However, there is a perennial shortage of donor organs. Left ventricular assist devices (LVAD) represent a revolutionary tool for temporizing heart failure that is refractory to medical management until a suitable organ becomes available. This review highlights the LVAD as a tool for bridging to transplant. The history of the LVAD and its use in heart transplantation is described, as well as the current indications for use in the general heart transplant candidate as well as for selected subpopulations. It also highlights the major complications of LVAD use, advancements in the field, and selected current controversies related to the LVAD as bridge-to-transplant therapy