2178Survival differences of left ventricle assist device carriers according to implantation eras - results from the European PCHF-VAD registry

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
N Jakus ◽  
J J Brugts ◽  
P Timmermans ◽  
A C Pouleur ◽  
P Rubis ◽  
...  

Abstract Background Developments in mechanical circulatory support have established left ventricular assist devices (LVAD) as a mainstay of therapy of advanced heart failure, resulting in improved outcomes in those implanted more recently - described as an “era effect” in the latest INTERMACS registry report. We aimed to study and describe the relevance of the era of device implant on outcomes in a European cohort of LVAD carriers. Methods 448 patients with continuous flow LVADs have been included in the multicentre PCHF-VAD registry formed by 12 European centres (mean age 52±13 years, 82% male). Patient data were divided to quartiles according to date of LVAD implantation. Results Baseline data of patients stratified by implant date quartiles are shown in Table 1. By Cox regression analysis, only the latest quartile was associated with significantly better one year survival, compared to the earliest quartile (Q4 vs. Q1: HR 0.44, 95% CI: 0.22–0.88, p=0.02) (Figure 1). Using a forward stepwise selection process, age and INTERMACS class at implant were the only other significant predictors of outcome; the reduction in all-cause mortality for the patients implanted in the latest quartile remained significant when adjusting for these variables (HR 0.47, 95% CI: 0.23–0.95, p=0.035). Table 1 Q1 (n=112) Q2 (n=112) Q3 (n=113) Q4 (n=111) p-value 6 Dec 2006–2 Jan 2012 3 Jan 2012–8 Dec 2014 9 Dec 2014–20 Jul 2016 21 Jul 2016–4 Apr 2018 CIED-D before VAD implant, n (%) 40 (35.7%) 50 (44.6%) 65 (57.5%) 85 (76.6%) <0.001 Age 47.8±13.8 53.4±11.9 54.0±12.5 54.3±12.9 <0.001 Female gender, n (%) 25 (22.3%) 22 (19.6%) 14 (12.4%) 20 (18.0%) 0.26 Arterial hypertension, n (%) 15 (13.4%) 34 (30.4%) 33 (29.2%) 20 (18.0%) 0.004 Diabetes mellitus, n (%) 13 (11.6%) 20 (17.9%) 26 (23.0%) 31 (27.9%) 0.017 Chronic kidney disease, n (%) 13 (11.6%) 20 (17.9%) 30 (26.5%) 39 (35.1%) <0.001 Coronary artery disease, n (%) 17 (15.2%) 23 (20.5%) 34 (30.1%) 37 (33.3%) 0.005 Chronic obstructive pulmonary disease, n (%) 1 (0.9%) 10 (8.9%) 14 (12.4%) 17 (15.3%) 0.002 Atrial fibrillation, n (%) 17 (15.2%) 33 (29.5%) 35 (31.0%) 43 (38.7%) 0.001 VAD type, HM2, n (%) 105 (93.8%) 90 (80.4%) 49 (43.4%) 2 (1.8%) <0.001 VAD type, HW, n (%) 0 (0.0%) 18 (16.1%) 42 (37.2%) 34 (30.6%) VAD type, HM3, n (%) 1 (0.9%) 0 (0.0%) 16 (14.2%) 70 (63.1%) VAD type, Other, n (%) 6 (5.4%) 4 (3.6%) 6 (5.3%) 5 (4.5%) VAD intention, BTT, n (%) 91 (86.7%) 88 (80.0%) 61 (58.1%) 65 (59.6%) <0.001 VAD intention, BTD, n (%) 8 (7.6%) 12 (10.9%) 28 (26.7%) 20 (18.3%) VAD intention, DT, n (%) 6 (5.7%) 10 (9.1%) 16 (15.2%) 24 (22.0%) INTERMACS class 1 27 (25.0%) 13 (11.7%) 23 (20.9%) 10 (9.3%) <0.001 INTERMACS class 2 41 (38.0%) 37 (33.3%) 19 (17.3%) 24 (22.2%) INTERMACS class 3 24 (22.2%) 27 (24.3%) 40 (36.4%) 48 (44.4%) INTERMACS class 4–7 16 (14.8%) 34 (30.6%) 28 (25.5%) 26 (24.1%) HM2, Heart Mate II; HW, HeartWare; HM3, HeartMate3; BTT, bridge to transplantation; BTD, bridge to decision; DT, destination therapy. Figure 1 Conclusion Despite a larger comorbidity burden, patients implanted most recently have better overall survival than those implanted in the earlier eras. This may be attributed to the increasing expertise of the implanting centres providing care for LVAD patients.

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Kairav Vakil ◽  
Rebecca Cogswell ◽  
Sue Duval ◽  
Wayne Levy ◽  
Peter Eckman ◽  
...  

Background: Current guidelines do not support routine use of implantable cardioverter-defibrillators (ICDs) in patients (pts) with end-stage heart failure (HF), unless these pts are awaiting advanced HF therapies such as left ventricular assist devices (LVADs) or a heart transplantation (HT). Whether ICDs improve survival in end-stage HF pts awaiting HT has not been previously examined in a large, multicenter cohort. Hypothesis: Presence of ICDs at time of listing for HT is associated with lower waitlist mortality. Methods: The United Network for Organ Sharing registry was used to identify adults (≥18 years) listed for HT between January 4, 1999 & September 30, 2014. Pts with congenital heart disease, total artificial heart, restrictive cardiomyopathy, prior HT, or missing covariates were excluded. Cox regression analysis was used to assess the impact of an ICD at the time of listing on waitlist mortality. Results: The analysis included 36,397 pts (mean age 53±12; 77% males) listed for HT. The prevalence of ICDs at listing has steadily increased over time before reaching a plateau in 2006 (27% in 1999, and range 76-82% between 2006-2014). In the unadjusted model, ICD use was associated with a 36% reduction in waitlist mortality (HR 0.64, 95% CI 0.60-0.68, p<0.001). After adjustment for covariates such as age, sex, race, creatinine, ischemic cardiomyopathy, and listing status, this association was nearly unchanged (HR 0.67, 95% CI 0.62-0.72, p<0.001). Test for interaction by listing era (pre- and post-2006) was non-significant (p=0.28). In the final adjusted model, that included listing era and LVAD status in addition to the above listed covariates, ICD use continued to remain associated with a mortality benefit on the waitlist for HT (HR 0.84, 95% CI 0.78-0.91, p<0.001). Conclusion: ICDs are increasingly prevalent in pts listed for HT; however many pts are still listed for HT without these devices. The presence of an ICD at the time of listing is associated with lower mortality on the waitlist. Although the magnitude of ICD efficacy diminishes slightly, its benefit continues to remain significant even after adjustment for listing era and LVAD use. Further analyses are required to identify specific sub-groups of pts where ICD use is most beneficial and appropriate.


2011 ◽  
Vol 2011 ◽  
pp. 1-9 ◽  
Author(s):  
Jens Garbade ◽  
Hartmuth B. Bittner ◽  
Markus J. Barten ◽  
Friedrich-Wilhelm Mohr

The shortage of appropriate donor organs and the expanding pool of patients waiting for heart transplantation have led to growing interest in alternative strategies, particularly in mechanical circulatory support. Improved results and the increased applicability and durability with left ventricular assist devices (LVADs) have enhanced this treatment option available for end-stage heart failure patients. Moreover, outcome with newer pumps have evolved to destination therapy for such patients. Currently, results using nonpulsatile continuous flow pumps document the evolution in outcomes following destination therapy achieved subsequent to the landmark Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure Trial (REMATCH), as well as the outcome of pulsatile designed second-generation LVADs. This review describes the currently available types of LVADs, their clinical use and outcomes, and focuses on the patient selection process.


Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 861
Author(s):  
Gennaro Martucci ◽  
Federico Pappalardo ◽  
Harikesh Subramanian ◽  
Giulia Ingoglia ◽  
Elena Conoscenti ◽  
...  

Heart failure (HF) remains a leading cause of morbidity, hospitalization, and mortality worldwide. Advancement of mechanical circulatory support technology has led to the use of continuous-flow left ventricular assist devices (LVADs), reducing hospitalizations, and improving quality of life and outcomes in advanced HF. Recent studies have highlighted how metabolic and endocrine dysfunction may be a consequence of, or associated with, HF, and may represent a novel (still neglected) therapeutic target in the treatment of HF. On the other hand, it is not clear whether LVAD support, may impact the outcome by also improving organ perfusion as well as improving the neuro-hormonal state of the patients, reducing the endocrine dysfunction. Moreover, endocrine function is likely a major determinant of human homeostasis, and is a key issue in the recovery from critical illness. Care of the endocrine function may contribute to improving cardiac contractility, immune function, as well as infection control, and rehabilitation during and after a LVAD placement. In this review, data on endocrine challenges in patients carrying an LVAD are gathered to highlight pathophysiological states relevant to this setting of patients, and to summarize the current therapeutic suggestions in the treatment of thyroid dysfunction, and vitamin D, erythropoietin and testosterone administration.


Author(s):  
Einar Gude ◽  
Arnt E. Fiane

AbstractHeart failure with preserved ejection fraction (HFpEF) is increasing in prevalence and represents approximately 50% of all heart failure (HF) patients. Patients with this complex clinical scenario, characterized by high filling pressures, and reduced cardiac output (CO) associated with progressive multi-organ involvement, have so far not experienced any significant improvement in quality of life or survival with traditional HF treatment. Left ventricular assist devices (LVAD) have offered a new treatment alternative in terminal heart failure patients with reduced ejection fraction (HFrEF), providing a unique combination of significant pressure and volume unloading together with an increase in CO. The small left ventricular cavity in HFpEF patients challenges left-sided pressure unloading, and new anatomical entry points need to be explored for mechanical pressure and volume unloading. Optimized and pressure/volume-adjusted mechanical circulatory support (MCS) devices for HFrEF patients may conceivably be customized for HFpEF anatomy and hemodynamics. We have developed a long-term MCS device for HFpEF patients with atrial unloading in a pulsed algorithm, leading to a significant reduction of filling pressure, maintenance of pulse pressure, and increase in CO demonstrated in animal testing. In this article, we will discuss HFpEF pathology, hemodynamics, and the principles behind our novel MCS device that may improve symptoms and prognosis in HFpEF patients. Data from mock-loop hemolysis studies, acute, and chronic animal studies will be presented.


2019 ◽  
Vol 57 (1) ◽  
pp. 183-188 ◽  
Author(s):  
Charles-Henri David ◽  
Astrid Quessard ◽  
Ciro Mastroianni ◽  
Guillaume Hekimian ◽  
Julien Amour ◽  
...  

Abstract OBJECTIVES Postcardiotomy cardiogenic shock (PCCS) is associated with high mortality rates of 50–80%. Although veno-arterial extracorporeal membrane oxygenation has been used as mechanical circulatory support in patients with PCCS, it is associated with a high rate of complications and poor quality of life. The Impella 5.0 and Impella Left Direct (LD) (Impella 5.0/LD) are minimally invasive left ventricular assist devices that provide effective haemodynamic support resulting in left ventricular unloading and systemic perfusion. Our goal was to describe the outcome of patients with PCCS supported with the Impella 5.0/LD at La Pitié-Salpêtrière Hospital. METHODS We retrospectively reviewed consecutive patients supported with the Impella 5.0/LD for PCCS between December 2010 and June 2015. Survival outcome and in-hospital complications were assessed. RESULTS A total of 29 patients (63 ± 14 years, 17% women) with PCCS were supported with the Impella 5.0/LD. At baseline, 69% experienced chronic heart failure, 66% had dilated cardiomyopathy and 57% had valvular disease. The mean EuroSCORE II was 22 ± 17 and the ejection fraction was 28 ± 11%. Most of the patients underwent isolated valve surgery (45%) or isolated coronary artery bypass grafting (38%). The mean duration of Impella support was 9 ± 7 days. Weaning from the Impella was successful in 72.4%, and 58.6% survived to discharge. Recovery of native heart function was observed in 100% of discharged patients. Survival to 30 days and to 1 year from Impella implant was 58.6% and 51.7%, respectively. CONCLUSIONS The Impella 5.0 and the Impella LD represent an excellent treatment option for critically ill patients with PCCS and are associated with favourable survival outcome and native heart recovery.


2021 ◽  
Vol 32 (4) ◽  
pp. 424-433
Author(s):  
Emalie Petersen

Heart failure is a leading cause of morbidity and mortality in the United States. Treatment of this condition increasingly involves mechanical circulatory support devices. Even with optimal medical therapy and use of simple cardiac devices, heart failure often leads to reduced quality of life and a shortened life span, prompting exploration of more advanced treatment approaches. Left ventricular assist devices constitute an effective alternative to cardiac transplantation. These devices are not without complications, however, and their use requires careful cooperative management by the patient’s cardiology team and primary care provider. Left ventricular assist devices have undergone many technological advancements since they were first introduced, and they will continue to evolve. This article reviews the history of different types of left ventricular assist devices, appropriate patient selection, and common complications in order to increase health professionals’ familiarity with these treatment options.


Author(s):  
Sung-Min Cho ◽  
J. Hunter Mehaffey ◽  
Susan L. Myers ◽  
Ryan S. Cantor ◽  
Randall C. Starling ◽  
...  

Background: Ischemic and hemorrhagic cerebrovascular accidents (ICVA and HCVA, respectively) remain common among patients with centrifugal-flow left ventricular assist devices (CF-LVADs), despite improvements in survival and device longevity. Therefore, the incidence of neurological adverse events (NAEs) associated with two contemporary CF-LVADs, the Abbott HeartMate3 ® (HM3) and the Medtronic HeartWare ™ HVAD ® (HVAD), were compared. Methods: Using the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs), we collected data on adult patients who received a CF-LVAD as a primary isolated implant between 1/1/2017 and 9/30/2019. Major NAEs were defined as transient ischemic attack (TIA), ICVA, and HCVA. The association of HVAD with risk of NAE in the first year post implant was evaluated using propensity score matching to balance for pre-implant risk factors. After matching, freedom from first major NAE in the HM3 and HVAD cohorts was compared with Kaplan-Meier curves. A secondary analysis using multivariable multiphase hazard models was used to identify predictors of NAE, which uses a data driven parametric fit of the early declining and constant phase hazards and the associations of risk factor with either phase. Results: Of 6,205 included patients, 3,076 (49.6%) received the HM3 and 3,129 (50.4%) received the HVAD. Median follow-up was 9 and 12 months (HM3 and HVAD). HVAD patients had more major NAEs (16.4% vs. 6.4%, p <0.001), as well as each subtype (TIA: 3.3% vs. 1.0%, p <0.001; ICVA: 7.7% vs. 3.4%, p <0.001; and HCVA: 7.2% vs. 2.0%, p <0.001), than did HM3 patients. A propensity-matched cohort balanced for pre-implant risk factors showed that HVAD was associated with higher probabilities of major NAEs (% freedom from NAE: 82% vs. 92%, p <0.001). Device type was not significantly associated with NAEs in the early hazard phase, but HVAD was associated with higher incidence of major NAEs during the constant hazard phase (hazard ratio: 5.71, confidence interval: 3.90-8.36). Conclusions: HM3 is associated with lower hazard of major NAEs than is HVAD beyond the early post-implantation period and during the constant hazard phase. Defining the explanation for this observation will inform device selection for individual patients.


1997 ◽  
Vol 6 (5) ◽  
pp. 355-362 ◽  
Author(s):  
DA Moroney ◽  
K Powers

Improvements in technology and in the selection, care, and treatment of patients have led to wider clinical use of mechanical circulatory support. Considerable progress has been made with the use of left ventricular assist devices. Patients are currently maintained in outpatient facilities until a donor heart becomes available; recently, left ventricular assist devices have started to be used as permanent implants. This article outlines the steps that are taken to prepare the patient, the patient's family, and the medical staff for discharge from the hospital of a patient supported with a left ventricular assist device. Extensive technical and clinical training of the primary caregiver and the patient is required to prepare for discharge from the hospital. Data are rapidly accumulating that show that left ventricular assist devices are safe and efficacious for outpatient use. Similar success is expected in clinical trials of permanent left ventricular assist devices, suggesting that many more patients will benefit from this technology in the future.


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