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1.
Article in English | MEDLINE | ID: mdl-38727533

ABSTRACT

Preoperative calculations showed that the 9-mm inlet, 6-mm outlet, 25-cc pump chambers and 65-73 bpm would be optimal for a 5-year-old patient suffering from restrictive cardiomyopathy, with a body surface area of 0.59 m2 (1.5 L/min flow for a cardiac index of 2.5). After re-sternotomy and standard bicaval cannulation for cardiopulmonary bypass, the procedure was performed under normothermic conditions and on the beating heart. Biventricular support was established with the Berlin Heart Excor using biatrial cannulation. For left atrial cannulation, induced ventricular fibrillation was used. The 9-mm inlet cannulas were inserted into the left and right atria, respectively. The 6-mm outlet cannulas were implanted using 8-mm interposition vascular grafts for the aorta and the main pulmonary artery, respectively. Cannulas were tunnelled through the epigastric space, with systems crossing outside of the body. The 25-cc chambers were used for both right ventricular assist device and left ventricular assist device support, which subsequently showed full emptying and filling.


Subject(s)
Cardiomyopathy, Restrictive , Heart-Assist Devices , Humans , Cardiomyopathy, Restrictive/surgery , Cardiomyopathy, Restrictive/diagnosis , Male , Child, Preschool , Heart Atria/surgery , Cardiac Catheterization/methods , Cardiac Catheterization/instrumentation , Heart Failure/surgery , Prosthesis Implantation/methods
2.
Bratisl Lek Listy ; 125(6): 343-346, 2024.
Article in English | MEDLINE | ID: mdl-38757589

ABSTRACT

INTRODUCTION: As the utilization of left-ventricular assist devices (LVADs) continues to rise and patients experience extended survival duration with these devices, the overall incidence of adverse events and complications has shown a notable increase. Among the major adverse events, thromboembolic complications are particularly significant. The aim of this study is to present our experience and assess the risk of thromboembolic complications after implantation of durable continuous-flow left-ventricular assist devices (CF-LVAD) in patients with end-stage heart failure. PATIENTS AND METHODS: From 2007 to 2022, 169 left ventricular continuous-flow durable mechanical assist devices were implanted at our institute. Three types of devices were employed: HeartMate II (n = 54, 32%), HeartMate 3 (n = 70, 41.4%), and Heart Ware (n = 45, 26.6%). The data were extracted from the EUROMACS register. RESULTS: Thromboembolic complication, pump thrombosis was observed in 11/169 patients (6.5%), with 2 patients experiencing stroke after embolism to the central nervous system. Among these cases, 10 patients (90.9%) were equipped with the Heart Ware device while 1 patient (9.1%) had the Heart Mate II device implanted. Nine patients received the durable device as a bridge to transplant therapy and two as a bridge to candidacy. The overall mean age of the patients was 47.6±10.2 years, with 2 women and 10 men. The pump thrombosis was managed through thrombolytic therapy, high-intensity heparin anticoagulation protocol, pump exchange, pump explantation, and early heart transplant. The combined hospital and long-term mortality rate was 4/11 patients (36.4%). CONCLUSION: Based on our experience, thromboembolic complications presenting primarily as pump thromboses, were a relatively common phenomenon experienced in association with the second-generation continuous-flow devices, but rarely seen with the third-generation devices. Thrombolysis followed by early heart transplantation proved to be a safe treatment option (Tab. 1, Ref. 14). Text in PDF www.elis.sk Keywords: durable mechanical assist device, durable left ventricular assist devices, outcomes, thromboembolic complications.


Subject(s)
Heart Failure , Heart-Assist Devices , Thromboembolism , Humans , Heart-Assist Devices/adverse effects , Male , Thromboembolism/etiology , Female , Middle Aged , Heart Failure/therapy , Adult , Aged
3.
Card Electrophysiol Clin ; 16(2): 125-132, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38749630

ABSTRACT

The population of patients with advanced heart failure continues to increase steadily as does the need for mechanical circulatory support. Combination therapy with left ventricular assist devices (LVADs) and cardiovascular implantable electronic devices (CIEDs) is unavoidable. CIED complications in patients with LVADs are common and often necessitate device system revision and transvenous lead extraction. Despite this, management recommendations are limited, and guidelines are lacking.


Subject(s)
Device Removal , Heart Failure , Heart-Assist Devices , Humans , Heart-Assist Devices/adverse effects , Device Removal/methods , Heart Failure/therapy , Heart Failure/surgery , Defibrillators, Implantable/adverse effects
4.
Curr Probl Cardiol ; 49(7): 102614, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38692447

ABSTRACT

Pulmonary hypertension (PH) with high pulmonary vascular resistance (PVR) is a very often diagnosed contraindication for orthotopic heart transplantation (OHT). It is a direct consequence of left ventricle failure characterized by high diastolic pressure obstructing the collection of blood from the pulmonary vessels. The occurrence of this situation grows with the increasing time of waiting for OHT, and with the progression of heart failure. Mechanical circulatory support (MCS) devices, particularly left ventricular assist devices (LVADs), have emerged as pivotal interventions for patients with fixed PH, offering a potential bridge to transplantation. The pathophysiological impact of PH in heart transplant candidates is profound, as it is associated with increased perioperative risk and heightened mortality post-transplantation. The selection of heart transplant candidates thus mandates a careful evaluation of PH, with an emphasis on distinguishing between reversible and fixed forms of the condition. Reversible PH can often be managed with medical therapies; however, fixed PH presents a more daunting challenge, necessitating more aggressive interventions like MCS. Patients are supported with LVADs until evidence of pulmonary afterload reversal is evident and then can be considered for heart transplantation. However, in those who are non-responders or have complications while being supported, their option for transplant is revoked. Despite these advancements, the heterogeneity of MCS devices and their mechanisms of action necessitates a nuanced understanding of their efficacy.


Subject(s)
Heart Failure , Heart Transplantation , Heart-Assist Devices , Hypertension, Pulmonary , Humans , Hypertension, Pulmonary/therapy , Hypertension, Pulmonary/etiology , Hypertension, Pulmonary/physiopathology , Heart Failure/therapy , Heart Failure/physiopathology , Treatment Outcome , Vascular Resistance/physiology
5.
Curr Probl Cardiol ; 49(7): 102619, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38723794

ABSTRACT

OBJECTIVE: This systematic review aims to assess the comparative effectiveness and safety of temporary mechanical circulatory support (MCS) devices in various subgroups of patients with acute cardiogenic shock, providing insights for personalized clinical decision-making. METHODS: We conducted a comprehensive search across major databases to identify studies that reported on the use of temporary MCS devices like TandemHeart, Impella, and VA-ECMO in acute cardiogenic shock. Special attention was given to subgroup analyses based on etiologies of shock, patient demographics, and comorbid conditions. RESULTS: Our analysis revealed that while devices like TandemHeart and Impella offer significant hemodynamic support, their effectiveness and safety profiles vary across different patient subgroups. VA-ECMO demonstrated the highest flow rates and potential for mortality benefits but requires careful management due to associated risks. The lack of randomized controlled trials in specific patient subgroups highlights a gap in the current literature, underscoring the need for targeted research. CONCLUSION: The review underscores the necessity of a personalized approach in selecting temporary MCS devices for patients with acute cardiogenic shock, guided by specific patient characteristics and clinical scenarios. Future research should focus on addressing the identified evidence gaps through well-designed studies that provide robust subgroup-specific data, enabling clinicians to optimize treatment strategies and improve patient outcomes in this critical care context.


Subject(s)
Extracorporeal Membrane Oxygenation , Heart-Assist Devices , Shock, Cardiogenic , Shock, Cardiogenic/therapy , Shock, Cardiogenic/mortality , Humans , Heart-Assist Devices/adverse effects , Extracorporeal Membrane Oxygenation/methods , Extracorporeal Membrane Oxygenation/adverse effects , Treatment Outcome , Acute Disease , Hemodynamics/physiology
6.
Crit Pathw Cardiol ; 23(2): 81-88, 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38768050

ABSTRACT

PURPOSE: We sought to characterize adaptive changes to the revised United Network for Organ Sharing donor heart allocation policy and estimate long-term survival trends for heart transplant (HTx) recipients. METHODS: Patients listed for HTx between October 17, 2013 and September 30, 2021 were identified from the United Network for Organ Sharing database, and stratified into pre- and postpolicy revision groups. Subanalyses were performed to examine trends in device utilization for extracorporeal membranous oxygenation (ECMO), durable left ventricular assist device (LVAD), intra-aortic balloon pump (IABP), microaxial support (Impella), and no mechanical circulatory support (non-MCS). Survival data post-HTx were fitted to parametric distributions and extrapolated to 5 years. RESULTS: We identified 27,523 HTx waitlist candidates during the study period, most of whom (n = 16,376) were waitlisted in the prepolicy change period. Overall, 19,554 patients underwent HTx during the study period (pre: 12,037 and post: 7517). Listings increased after the policy change for ECMO ( P < 0.01), Impella ( P < 0.01), and IABP ( P < 0.01) patients. Listings for LVAD ( P < 0.01) and non-MCS ( P < 0.01) patients decreased. HTx increased for ECMO ( P < 0.01), Impella ( P < 0.01), and IABP ( P < 0.01) patients after the policy change and decreased for LVAD ( P < 0.01) and non-MCS ( P < 0.01) patients. Waitlist survival increased for the overall ( P < 0.01), ECMO ( P < 0.01), IABP ( P < 0.01), and non-MCS ( P < 0.01) groups. Waitlist survival did not differ for the LVAD ( P = 0.8) and Impella ( P = 0.1) groups. Post-transplant survival decreased for the overall ( P < 0.01), LVAD ( P < 0.01), and non-MCS ( P < 0.01) populations. CONCLUSIONS: Allocation policy revisions have contributed to greater utilization of ECMO, Impella, and IABP, decreased utilization of LVADs and non-MCS, increased waitlist survival, and decreased post-HTx survival.


Subject(s)
Databases, Factual , Heart Transplantation , Tissue and Organ Procurement , Waiting Lists , Humans , Male , Female , Middle Aged , United States/epidemiology , Waiting Lists/mortality , Adult , Heart-Assist Devices/statistics & numerical data , Tissue Donors/supply & distribution , Survival Rate/trends , Extracorporeal Membrane Oxygenation , Heart Failure/mortality , Heart Failure/therapy , Retrospective Studies , Intra-Aortic Balloon Pumping/statistics & numerical data
7.
Isr Med Assoc J ; 26(5): 278-282, 2024 May.
Article in English | MEDLINE | ID: mdl-38736341

ABSTRACT

BACKGROUND: Long-term support with a HeartMate 3 (HM3) left ventricular assist device (LVAD) has improved outcomes of patients with end-stage heart failure. However, there is a paucity of data on the outcomes of patients who underwent concomitant cardiac surgical procedure (CCSP) during HM3-LVAD implantation. OBJECTIVES: To assess our single-center experience with patients who underwent CCSP during the implantation of an HM3-LVAD. METHODS: From December 2016 until April 2022, 131 adult patients underwent HM3-LVAD implantation. A total of 23 patients underwent CCSP during the HM3-LVAD implantation+CCSP, and 108 underwent only HM3-LVAD implantation (HM3-only). RESULTS: The median age was 59 ± 11 years (range 54-67), 82% (n=108) were male, and 76% (n=100) were implanted as a bridge-to-transplant. The concomitant procedures performed during the implantation included 8 aortic valve repairs/replacements, 14 tricuspid valve repairs, 4 patent foramen ovales or atrial septal defect closures, and 3 other cardiac procedures. The mean cardiopulmonary bypass time was 113 ± 58 minutes for the HM3-only group and 155 ± 47 minutes for the HM3+CCSP group (P = 0.007). The mortality rates at 30 days, 6 months, and 12 months post-implantation were 2 (9%), 5 (22%), and 6 (26%) respectively for the HM3+CCSP group, and 7 (6%), 18 (17%), and 30 (28%) for the HM3-only group (P = 0.658, 0.554, and 1.000). CONCLUSIONS: Our experience demonstrated no significant difference in the 30-day, 6-month, and 12-month mortality rates for patients who underwent a CCSP during HM3-LVAD implantation compared to patients who did not undergo CCSP during HM3-LVAD implantation.


Subject(s)
Cardiac Surgical Procedures , Heart Failure , Heart-Assist Devices , Humans , Heart-Assist Devices/statistics & numerical data , Male , Female , Middle Aged , Heart Failure/surgery , Heart Failure/mortality , Heart Failure/therapy , Aged , Cardiac Surgical Procedures/methods , Retrospective Studies , Treatment Outcome , Prosthesis Implantation/methods
8.
J Am Heart Assoc ; 13(10): e033590, 2024 May 21.
Article in English | MEDLINE | ID: mdl-38742529

ABSTRACT

BACKGROUND: The new heart allocation policy places veno-arterial extracorporeal membrane oxygenation (VA-ECMO)-supported heart transplant (HT) candidates at the highest priority status. Despite increasing evidence supporting left ventricular (LV) unloading during VA-ECMO, the effect of LV unloading on transplant outcomes following bridging to HT with VA-ECMO remains unknown. METHODS AND RESULTS: From October 18, 2018 to March 21, 2023, 624 patients on VA-ECMO at the time of HT were identified in the United Network for Organ Sharing database and were divided into 2 groups: VA-ECMO alone (N=384) versus VA-ECMO with LV unloading (N=240). Subanalysis was performed in the LV unloading group: Impella (N=106) versus intra-aortic balloon pump (N=134). Recipient age was younger in the VA-ECMO alone group (48 versus 53 years, P=0.018), as was donor age (VA-ECMO alone, 29 years versus LV unloading, 32 years, P=0.041). One-year survival was comparable between groups (VA-ECMO alone, 88.0±1.8% versus LV unloading, 90.4±2.1%; P=0.92). Multivariable Cox hazard model showed LV unloading was not associated with posttransplant mortality after HT (hazard ratio, 0.92; P=0.70). Different LV unloading methods had similar 1-year survival (intra-aortic balloon pump, 89.2±3.0% versus Impella, 92.4±2.8%; P=0.65). Posttransplant survival was comparable between different Impella versions (Impella 2.5, versus Impella CP, versus Impella 5.0, versus Impella 5.5). CONCLUSIONS: Under the current allocation policy, LV unloading did not impact waitlist outcome and posttransplant survival in patients bridged to HT with VA-ECMO, nor did mode of LV unloading. This highlights the importance of a tailored approach in HT candidates on VA-ECMO, where routine LV unloading may not be universally necessary.


Subject(s)
Extracorporeal Membrane Oxygenation , Heart Transplantation , Heart-Assist Devices , Humans , Extracorporeal Membrane Oxygenation/methods , Male , Female , Middle Aged , Adult , Ventricular Function, Left , Retrospective Studies , Tissue and Organ Procurement/methods , Treatment Outcome , United States/epidemiology , Heart Failure/physiopathology , Heart Failure/mortality , Heart Failure/therapy , Heart Failure/surgery , Time Factors , Waiting Lists/mortality , Intra-Aortic Balloon Pumping
9.
Int J Artif Organs ; 47(5): 329-337, 2024 May.
Article in English | MEDLINE | ID: mdl-38742880

ABSTRACT

BACKGROUND: This study investigates the hypothesis that presence of atrial fibrillation (AF) in LVAD patients increases thrombogenicity in the left ventricle (LV) and exacerbates stroke risk. METHODS: Using an anatomical LV model implanted with an LVAD inflow cannula, we analyze thrombogenic risk and blood flow patterns in either AF or sinus rhythm (SR) using unsteady computational fluid dynamics (CFD). To analyze platelet activation and thrombogenesis in the LV, hundreds of thousands of platelets are individually tracked to quantify platelet residence time (RT) and shear stress accumulation history (SH). RESULTS: The irregular and chaotic mitral inflow associated with AF results in markedly different intraventricular flow patterns, with profoundly negative impact on blood flow-induced stimuli experienced by platelets as they traverse the LV. Twice as many platelets accumulated very high SH in the LVAD + AF case, resulting in a 36% increase in thrombogenic potential score, relative to the LVAD + SR case. CONCLUSIONS: This supports the hypothesis that AF results in unfavorable blood flow patterns in the LV adding to an increased stroke risk for LVAD + AF patients. Quantification of thrombogenic risk associated with AF for LVAD patients may help guide clinical decision-making on interventions to mitigate the increased risk of thromboembolic events.


Subject(s)
Atrial Fibrillation , Heart-Assist Devices , Atrial Fibrillation/physiopathology , Atrial Fibrillation/etiology , Heart-Assist Devices/adverse effects , Humans , Thrombosis/etiology , Thrombosis/physiopathology , Platelet Activation , Models, Cardiovascular , Heart Ventricles/physiopathology , Heart Ventricles/diagnostic imaging , Stroke/etiology , Blood Platelets/metabolism , Ventricular Function, Left , Models, Anatomic , Hydrodynamics , Hemodynamics
10.
BMC Palliat Care ; 23(1): 128, 2024 May 22.
Article in English | MEDLINE | ID: mdl-38778297

ABSTRACT

BACKGROUND: Values are broadly understood to have implications for how individuals make decisions and cope with serious illness stressors, yet it remains uncertain how patients and their family and friend caregivers discuss, reflect upon, and act on their values in the post-left ventricular assist device (LVAD) implantation context. This study aimed to explore the values elicitation experiences of patients with an LVAD in the post-implantation period. METHODS: Qualitative descriptive study of LVAD recipients. Socio-demographics and patient resource use were analyzed using descriptive statistics and semi-structured interview data using thematic analysis. Adult (> 18 years) patients with an LVAD receiving care at an outpatient clinic in the Southeastern United States. RESULTS: Interviewed patients (n = 27) were 30-76 years, 59% male, 67% non-Hispanic Black, 70% married/living with a partner, and 70% urban-dwelling. Three broad themes of patient values elicitation experiences emerged: 1) LVAD implantation prompts deep reflection about life and what is important, 2) patient values are communicated in various circumstances to convey personal goals and priorities to caregivers and clinicians, and 3) patients leverage their values for strength and guidance in navigating life post-LVAD implantation. LVAD implantation was an impactful experience often leading to reevaluation of patients' values; these values became instrumental to making health decisions and coping with stressors during the post-LVAD implantation period. Patient values arose within broad, informal exchanges and focused, decision-making conversations with their caregiver and the healthcare team. CONCLUSIONS: Clinicians should consider assessing the values of patients post-implantation to facilitate shared understanding of their goals/priorities and identify potential changes in their coping.


Subject(s)
Heart-Assist Devices , Qualitative Research , Humans , Heart-Assist Devices/psychology , Male , Middle Aged , Female , Adult , Aged , Adaptation, Psychological
11.
Pediatr Transplant ; 28(4): e14787, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38766980

ABSTRACT

BACKGROUND: Children awaiting heart transplant (Tx) have a high risk of death due to donor organ scarcity. Historically, ventricular assist devices (VADs) reduced waitlist mortality, prompting increased VAD use. We sought to determine whether the VAD survival benefit persists in the current era. METHODS: Using the Scientific Registry of Transplant Recipients, we identified patients listed for Tx between 3/22/2016 and 9/1/2020. We compared characteristics of VAD and non-VAD groups at Tx listing. Cox proportional hazards models were used to identify risk factors for 1-year waitlist mortality. RESULTS: Among 5054 patients, 764 (15%) had a VAD at Tx listing. The VAD group was older with more mechanical ventilation and renal impairment. Unadjusted waitlist mortality was similar between groups; the curves crossed ~90 days after listing (p = .55). In multivariable analysis, infant age (HR 2.77, 95%CI 2.13-3.60), Black race (HR 1.57, 95%CI 1.31-1.88), congenital heart disease (HR 1.23, 95%CI 1.04-1.46), renal impairment (HR 2.67, 95%CI 2.19-3.26), inotropes (HR 1.28, 95%CI 1.09-1.52), and mechanical ventilation (HR 2.23, 95%CI 1.84-2.70) were associated with 1-year waitlist mortality. VADs were not associated with mortality in the first 90 waitlist days but were protective for those waiting ≥90 days (HR 0.43, 95%CI 0.26-0.71). CONCLUSIONS: In the current era, VADs reduce waitlist mortality, but only for those waitlisted ≥90 days. The differential effect by race, size, and VAD type is less clear. These findings suggest that Tx listing without VAD may be reasonable if a short waitlist time is anticipated, but VADs may benefit those expected to wait >90 days.


Subject(s)
Heart Transplantation , Heart-Assist Devices , Registries , Waiting Lists , Humans , Waiting Lists/mortality , Male , Female , Infant , Child , Child, Preschool , Adolescent , Risk Factors , Databases, Factual , Proportional Hazards Models , Retrospective Studies , Heart Failure/mortality , Heart Failure/surgery , Heart Failure/therapy , United States/epidemiology
12.
Clin Transplant ; 38(5): e15330, 2024 May.
Article in English | MEDLINE | ID: mdl-38716787

ABSTRACT

INTRODUCTION: Since the 2018 change in the US adult heart allocation policy, more patients are bridged-to-transplant on temporary mechanical circulatory support (tMCS). Previous studies indicate that durable left ventricular assist devices (LVAD) may lead to allosensitization. The goal of this study was to assess whether tMCS implantation is associated with changes in sensitization. METHODS: We included patients evaluated for heart transplants between 2015 and 2022 who had alloantibody measured before and after MCS implantation. Allosensitization was defined as development of new alloantibodies after tMCS implant. RESULTS: A total of 41 patients received tMCS before transplant. Nine (22.0%) patients developed alloantibodies following tMCS implantation: 3 (12.0%) in the intra-aortic balloon pump group (n = 25), 2 (28.6%) in the microaxial percutaneous LVAD group (n = 7), and 4 (44.4%) in the veno-arterial extra-corporeal membrane oxygenation group (n = 9)-p = .039. Sensitized patients were younger (44.7 ± 11.6 years vs. 54.3 ± 12.5 years, p = .044), were more likely to be sensitized at baseline - 3 of 9 (33.3%) compared to 2 out of 32 (6.3%) (p = .028) and received more transfusions with red blood cells (6 (66.6%) vs. 8 (25%), p = .02) and platelets (6 (66.6%) vs. 5 (15.6%), p = .002). There was no significant difference in tMCS median duration of support (4 [3,15] days vs. 8.5 [5,14.5] days, p = .57). Importantly, out of the 11 patients who received a durable LVAD after tMCS, 5 (45.5%) became sensitized, compared to 4 out of 30 patients (13.3%) who only had tMCS-p = .028. CONCLUSIONS: Our findings suggest that patients bridged-to-transplant with tMCS, without significant blood product transfusions and a subsequent durable LVAD implant, have a low risk of allosensitization. Further studies are needed to confirm our findings and determine whether risk of sensitization varies by type of tMCS and duration of support.


Subject(s)
Heart Transplantation , Heart-Assist Devices , Isoantibodies , Humans , Male , Female , Middle Aged , Isoantibodies/immunology , Isoantibodies/blood , Follow-Up Studies , Adult , Risk Factors , Prognosis , Retrospective Studies , Heart Failure/surgery , Heart Failure/therapy , Graft Rejection/etiology
13.
J Heart Lung Transplant ; 43(6): 889-900, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38713124

ABSTRACT

BACKGROUND: There is no FDA-approved left ventricular assist device (LVAD) for smaller children permitting routine hospital discharge. Smaller children supported with LVADs typically remain hospitalized for months awaiting heart transplant-a major burden for families and a challenge for hospitals. We describe the initial outcomes of the Jarvik 2015, a miniaturized implantable continuous flow LVAD, in the NHLBI-funded Pumps for Kids, Infants, and Neonates (PumpKIN) study, for bridge-to-heart transplant. METHODS: Children weighing 8 to 30 kg with severe systolic heart failure and failing optimal medical therapy were recruited at 7 centers in the United States. Patients with severe right heart failure and single-ventricle congenital heart disease were excluded. The primary feasibility endpoint was survival to 30 days without severe stroke or non-operational device failure. RESULTS: Of 7 children implanted, the median age was 2.2 (range 0.7, 7.1) years, median weight 10 (8.2 to 20.7) kilograms; 86% had dilated cardiomyopathy; 29% were INTERMACS profile 1. The median duration of Jarvik 2015 support was 149 (range 5 to 188) days where all 7 children survived including 5 to heart transplant, 1 to recovery, and 1 to conversion to a paracorporeal device. One patient experienced an ischemic stroke on day 53 of device support in the setting of myocardial recovery. One patient required ECMO support for intractable ventricular arrhythmias and was eventually transplanted from paracorporeal biventricular VAD support. The median pump speed was 1600 RPM with power ranging from 1-4 Watts. The median plasma free hemoglobin was 19, 30, 19 and 30 mg/dL at 7, 30, 90 and 180 days or time of explant, respectively. All patients reached the primary feasibility endpoint. Patient-reported outcomes with the device were favorable with respect to participation in a full range of activities. Due to financial issues with the manufacturer, the study was suspended after consent of the eighth patient. CONCLUSION: The Jarvik 2015 LVAD appears to hold important promise as an implantable continuous flow device for smaller children that may support hospital discharge. The FDA has approved the device to proceed to a 22-subject pivotal trial. Whether this device will survive to commercialization remains unclear because of the financial challenges faced by industry seeking to develop pediatric medical devices. (Supported by NIH/NHLBI HHS Contract N268201200001I, clinicaltrials.gov 02954497).


Subject(s)
Feasibility Studies , Heart Failure , Heart-Assist Devices , Humans , Child, Preschool , Child , Male , Infant , Female , Prospective Studies , Heart Failure/therapy , Heart Failure/surgery , Heart Failure/physiopathology , Miniaturization , Prosthesis Design , Treatment Outcome , United States
15.
Curr Probl Cardiol ; 49(7): 102564, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38599561

ABSTRACT

While there has been a global decrease in rates of heart failure (HF) prevalence between 1990 and 2019, the Eastern Mediterranean region (EMR) is experiencing an increase. In 2019, approximately 1,229,766 individuals lived with moderate to severe HF in the EMR. Despite the growth in the utilization of advanced heart failure (AHF) therapies in the EMR in the past two decades, current volumes are yet to meet the growing AHF burden in the region. Heart transplantation (HT) volumes in EMR have grown from 9 in the year 2000 to 179 HTs in 2019. However, only a few centers provide the full spectrum of AHF therapies, including durable mechanical circulatory support (MCS) and HT. Published data on the utilization of left ventricular assist devices (LVAD) in the EMR are scarce. Notably, patients undergoing LVAD implantation in the EMR are on average, 13 year younger, and more likely to present with critical cardiogenic shock, as compared to their counterparts in the Western world. Furthermore, AHF care in the region is hampered by the paucity of multidisciplinary HF programs, inherent costs of AHF therapies, limited access to short and long-term MCS, organ shortage, and lack of public awareness and acceptance of AHF therapeutics. All stakeholders in the EMR should work together to strategize tackling the challenging AHF burden in the region.


Subject(s)
Heart Failure , Heart Transplantation , Heart-Assist Devices , Humans , Heart Failure/therapy , Heart Failure/epidemiology , Heart Transplantation/statistics & numerical data , Mediterranean Region/epidemiology
16.
Curr Probl Cardiol ; 49(7): 102579, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38653439

ABSTRACT

BACKGROUND: Pulmonary hypertension (PH) poses a significant challenge in the selection of candidates for heart transplantation, impacting their eligibility and post-transplant outcomes. Mechanical circulatory support (MCS) devices, particularly left ventricular assist devices (LVADs), have emerged as a therapeutic option to manage PH in this patient population. This systematic review aims to evaluate the effectiveness of MCS devices in reversing fixed pulmonary hypertension in heart transplant candidates. METHODS: A comprehensive literature search was conducted across multiple databases, including PubMed, Scopus, and Web of Science, to identify studies that evaluated the effectiveness of MCS devices in reversing fixed pulmonary hypertension in heart transplant candidates. Data on pulmonary vascular resistance, PH reversal, heart transplant eligibility, and post-transplant outcomes were extracted and synthesized. RESULTS: The review included studies that demonstrated the potential of MCS devices, especially LVADs, to significantly reduce pulmonary vascular resistance and reverse fixed pulmonary hypertension in heart transplant candidates. These findings suggest that MCS devices can improve transplant eligibility and may positively impact post-transplant survival rates. However, the literature also indicates a need for further comparative studies to optimize MCS device selection and treatment protocols. CONCLUSION: MCS devices, particularly LVADs, play a crucial role in the management of fixed pulmonary hypertension in heart transplant candidates, improving their eligibility for transplantation and potentially enhancing post-transplant outcomes. Future research should focus on comparative effectiveness studies to guide clinical decision-making and optimize patient care in this challenging clinical scenario.


Subject(s)
Heart Transplantation , Heart-Assist Devices , Hypertension, Pulmonary , Humans , Hypertension, Pulmonary/therapy , Heart Failure/therapy , Heart Failure/complications , Treatment Outcome , Vascular Resistance/physiology
17.
Heart Lung ; 66: 117-122, 2024.
Article in English | MEDLINE | ID: mdl-38604055

ABSTRACT

BACKGROUND: The use of left ventricular assist devices (LVADs) is increasing with an estimated 2500 devices implanted each year. When burdens of the LVAD outweigh benefits, most individuals with LVADs will undergo deactivation in the hospital setting. While the decision to deactivate an LVAD is considered an ethical practice, little is known about the experience and needs of bereaved family members. OBJECTIVE: To investigate the experiences of bereaved family members of patients who died following LVAD deactivation. METHODS: In this qualitative study, 11 family members of patients who underwent LVAD deactivation were interviewed. The semi-structured interviews were conducted until data saturation was reached and relevant themes emerged. RESULTS: This qualitative study was conducted to understand the experience of family members before, during and after the patient underwent LVAD deactivation, including their perceptions of engagement with the healthcare team. Analysis revealed six overarching themes from the experience, including 1) hope for survival, 2) communication, 3) spirituality and faith, 4) absence of physical suffering, 5) positive relationships with staff, 6) post-death care needs. CONCLUSION: Bereaved family members of patients undergoing LVAD deactivation have unique lived experiences and concerns. This study highlights the importance of effective communication not only near end-of-life but throughout the LVAD experience. While the positive relationships with staff and the absence of physical suffering were strengths identified by bereaved caregivers, there is an opportunity for improvement, particularly during the decision-making and post-death periods.


Subject(s)
Bereavement , Family , Heart-Assist Devices , Qualitative Research , Humans , Heart-Assist Devices/psychology , Male , Female , Family/psychology , Middle Aged , Adult , Aged , Heart Failure/psychology , Withholding Treatment , Interviews as Topic
18.
J Biomech Eng ; 146(10)2024 Oct 01.
Article in English | MEDLINE | ID: mdl-38683061

ABSTRACT

Computational fluid dynamics (CFD) simulations are widely used to develop and analyze blood-contacting medical devices such as left ventricular assist devices (LVADs). This work presents an analysis of the transient behavior of two centrifugal LVADs with different designs: HeartWare VAD and HeartMate3. A scale-resolving methodology is followed through Large Eddy Simulations, which allows for the visualization of turbulent structures. The three-dimensional (3D) LVAD models are coupled to a zero-dimensional (0D) 2-element Windkessel model, which accounts for the vascular resistance and compliance of the arterial system downstream of the device. Furthermore, both continuous- and pulsatile-flow operation modes are analyzed. For the pulsatile conditions, the artificial pulse of HeartMate3 is imposed, leading to a larger variation of performance variables in HeartWare VAD than in HeartMate3. Moreover, CFD results of pulsatile-flow simulations are compared to those obtained by accessing the quasi-steady maps of the pumps. The quasi-steady approach is a predictive tool used to provide a preliminary approximation of the pulsatile evolution of flow rate, pressure head, and power, by only imposing a speed pulse and vascular parameters. This preliminary quasi-steady solution can be useful for deciding the characteristics of the pulsatile speed law before running a transient CFD simulation, as the former entails a significant reduction in computational cost in comparison to the latter.


Subject(s)
Heart-Assist Devices , Hydrodynamics , Pulsatile Flow , Models, Cardiovascular , Computer Simulation , Centrifugation , Humans
19.
Eur J Cardiothorac Surg ; 65(5)2024 May 03.
Article in English | MEDLINE | ID: mdl-38603625

ABSTRACT

We present the case of a 52-year-old woman with cardiogenic shock and refractory right ventricular failure due to spontaneous dissection of the right coronary artery. She remained dependent on mechanical support for several weeks. Both a right ventricular assist device implant and a bidirectional cavopulmonary anastomosis were explored as long-term support options. A history of malignancy and possible right ventricular functional recovery resulted in a decision in favour of the bidirectional cavopulmonary anastomosis and concomitant tricuspid valve annuloplasty. Postoperatively her clinical condition improved significantly, and she could be discharged home. Echocardiography showed normalization of right ventricular dimensions and slight improvement of right ventricular function.


Subject(s)
Heart Failure , Myocardial Infarction , Humans , Female , Middle Aged , Heart Failure/surgery , Heart Failure/etiology , Myocardial Infarction/surgery , Myocardial Infarction/complications , Ventricular Dysfunction, Right/surgery , Ventricular Dysfunction, Right/etiology , Ventricular Dysfunction, Right/physiopathology , Fontan Procedure/adverse effects , Heart-Assist Devices , Heart Ventricles/surgery , Heart Ventricles/diagnostic imaging
20.
Heart Lung ; 66: 56-70, 2024.
Article in English | MEDLINE | ID: mdl-38583277

ABSTRACT

BACKGROUND: Social determinants of health (SDOH) may influence the clinical management of patients with heart failure. Further research is warranted on the relationship between SDOH and Ventricular Assist Device (VAD) therapy for heart failure. OBJECTIVES: The purpose of this integrative review was to synthesize the state of knowledge on the intersection of SDOH with VAD therapy. METHODS: Guided by Whittemore and Knafl's methodology, this literature search captured three concepts of interest including VAD therapy, SDOH, and their domains of intersection with patient selection, decision-making, treatment outcome, and resource allocation. CINAHL, Embase, PsycINFO, PubMed, and Web of Science were searched in March 2023. Articles were included if they were peer-reviewed publications in English, published between 2006 and 2023, conducted in the United States, and examined VAD therapy in the context of adult patients (age ≥ 18 years). RESULTS: 22 quantitative studies meeting the inclusion criteria informed the conceptualization of SDOH using the Healthy People 2030 framework. Four themes captured how the identified SDOH intersected with different processes relating to VAD therapy: patient decision-making, healthcare access and resource allocation, patient selection, and treatment outcomes. Most studies addressed the intersection of SDOH with healthcare access and treatment outcomes. CONCLUSION: This review highlights substantial gaps in understanding how SDOH intersect with patient and patient selection for VAD. More research using mixed methods designs is warranted. On an institutional level, addressing bias and discrimination may have mitigated health disparities with treatment outcomes, but further research is needed for implementing system-wide change. Standardized assessment of SDOH is recommended throughout clinical practice from patient selection to outpatient VAD care.


Subject(s)
Heart Failure , Heart-Assist Devices , Social Determinants of Health , Humans , Heart-Assist Devices/statistics & numerical data , Heart Failure/therapy , Patient Selection
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