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Science (New York, N.Y.) Jul 2022Scalable biofabrication of heart helical tissue pattern augments pumping function.
Scalable biofabrication of heart helical tissue pattern augments pumping function.
Topics: Bioengineering; Heart; Heart, Artificial; Humans; Myocardial Contraction; Prosthesis Design
PubMed: 35857553
DOI: 10.1126/science.add0829 -
Current Opinion in Organ Transplantation Jun 2022Since the first implantation of a total artificial heart (TAH) 50 years ago the devices and technique have evolved to provide reliable support for patients with... (Review)
Review
PURPOSE OF REVIEW
Since the first implantation of a total artificial heart (TAH) 50 years ago the devices and technique have evolved to provide reliable support for patients with biventricular failure as a bridge to heart transplant. The purpose of this review is to discuss the history and evolution of devices, current devices, critical aspects of patient selection, tips and pitfalls of implantation, and future directions.
RECENT FINDINGS
The most studied device on the market is the SynCardia TAH, which has been implanted in over 2000 patients worldwide and is the only device that is currently Food and Drug Administration approved as a bridge to transplant. The overall survival in patients supported by the device at 1 year is 42% while those that make it to transplant have a 1 year post transplant survival of 83%. A newer device the Aeson TAH (Carmat, Velizy-Villacoublay, France) was first implanted in France in 2013 and is currently under clinical trial in the United States.
SUMMARY
Significant progress has been made in both the technology and technique of TAH implantation and these devices remain both a reliable and sometimes only option for patients with severe biventricular heart failure.
Topics: France; Heart Failure; Heart Transplantation; Heart, Artificial; Humans; Transplants; United States
PubMed: 35649113
DOI: 10.1097/MOT.0000000000000982 -
The Journal of Heart and Lung... Aug 2021While rates of stroke have declined with the HeartMate3 (HM3) continuous- flow (CF) left ventricular assist device (LVAD), the impact of non-pulsatile flow and... (Comparative Study)
Comparative Study
BACKGROUND
While rates of stroke have declined with the HeartMate3 (HM3) continuous- flow (CF) left ventricular assist device (LVAD), the impact of non-pulsatile flow and artificial pulse physiology on cerebrovascular function is not known. We hypothesized that improved hemodynamics and artificial pulse physiology of HM3 patients would augment cerebrovascular metabolic reactivity (CVR) compared with HeartMate II (HMII) CF-LVAD and heart failure (HF) patients.
METHODS
Mean, peak systolic and diastolic flow velocities (MFV, PSV, MinFV, respectively) and cerebral pulsatility index were determined in the middle cerebral artery (MCA) before and after a 30 sec breath-hold challenge in 90 participants: 24 healthy controls; 30 HF, 15 HMII, and 21 HM3 patients.
RESULTS
In HM3 patients, breath-holding increased MFV (Δ8 ± 10 cm/sec, p < .0001 vs baseline) to levels similar to HF patients (Δ9 ± 8 cm/sec, p > .05), higher than HMII patients (Δ2 ± 8 cm/sec, p < .01) but lower than healthy controls (Δ13 ± 7 cm/sec, p < .05). CF-LVAD altered the proportion of systolic and diastolic flow responses as reflected by a differential cerebral pulsatility index (p = .03). Baseline MFV was not related to CVR (r = 0.0008, p = .81). However, CF-LVAD pump speed was strongly inversely associated with CVR in HM II (r = 0.51, p = .003) but not HM3 patients (r = 0.01, p = .65).
CONCLUSIONS
Compared with HMII, HM3 patients have a significantly improved CVR. However, CVR remains lower in HM3 and HF patients than in healthy controls, therefore suggesting that changes in cerebral hemodynamics are not reversed by CF-LVAD therapy. Further research on the mechanisms and the long-term impact of altered cerebral hemodynamics in this unique patient population are warranted.
Topics: Cerebrovascular Circulation; Diastole; Equipment Design; Female; Heart Failure; Heart-Assist Devices; Homeostasis; Humans; Male; Middle Aged; Middle Cerebral Artery; Pulsatile Flow; Regional Blood Flow; Stroke Volume; Ultrasonography, Doppler, Transcranial; Vasodilation
PubMed: 34134913
DOI: 10.1016/j.healun.2021.05.005 -
BMC Cardiovascular Disorders Feb 2022Mechanical circulatory support (MCS) devices are widely used for cardiogenic shock (CS). This network meta-analysis aims to evaluate which MCS strategy offers advantages. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Mechanical circulatory support (MCS) devices are widely used for cardiogenic shock (CS). This network meta-analysis aims to evaluate which MCS strategy offers advantages.
METHODS
A systemic search of PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials was performed. Studies included double-blind, randomized controlled, and observational trials, with 30-day follow-ups. Paired independent researchers conducted the screening, data extraction, quality assessment, and consistency and heterogeneity assessment.
RESULTS
We included 39 studies (1 report). No significant difference in 30-day mortality was noted between venoarterial extracorporeal membrane oxygenation (VA-ECMO) and VA-ECMO plus Impella, Impella, and medical therapy. According to the surface under the cumulative ranking curve, the optimal ranking of the interventions was surgical venting plus VA-ECMO, medical therapy, VA-ECMO plus Impella, intra-aortic balloon pump (IABP), Impella, Tandem Heart, VA-ECMO, and Impella plus IABP. Regarding in-hospital mortality and 30-day mortality, the forest plot showed low heterogeneity. The results of the node-splitting approach showed that direct and indirect comparisons had a relatively high consistency.
CONCLUSIONS
IABP more effectively reduce the incidence of 30-day mortality compared with VA-ECMO and Impella for the treatment of CS.
Topics: Extracorporeal Membrane Oxygenation; Heart, Artificial; Heart-Assist Devices; Hospital Mortality; Humans; Intra-Aortic Balloon Pumping; Network Meta-Analysis; Observational Studies as Topic; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Shock, Cardiogenic; Time Factors; Treatment Outcome
PubMed: 35152887
DOI: 10.1186/s12872-022-02493-0 -
The Annals of Thoracic Surgery Nov 2019
Topics: Cardiac Surgical Procedures; Heart Ventricles; Heart, Artificial; Humans; Patient Selection; Prosthesis Implantation
PubMed: 31520634
DOI: 10.1016/j.athoracsur.2019.09.002 -
Annual Review of Biomedical Engineering Jun 2022The treatment of end-stage heart failure has evolved substantially with advances in medical treatment, cardiac transplantation, and mechanical circulatory support (MCS)... (Review)
Review
The treatment of end-stage heart failure has evolved substantially with advances in medical treatment, cardiac transplantation, and mechanical circulatory support (MCS) devices such as left ventricular assist devices and total artificial hearts. However, current MCS devices are inherently blood contacting and can lead to potential complications including pump thrombosis, hemorrhage, stroke, and hemolysis. Attempts to address these issues and avoid blood contact led to the concept of compressing the failing heart from the epicardial surface and the design of direct cardiac compression (DCC) devices. We review the fundamental concepts related to DCC, present the foundational devices and recent devices in the research and commercialization stages, and discuss the milestones required for clinical translation and adoption of this technology.
Topics: Biomechanical Phenomena; Heart; Heart Failure; Heart, Artificial; Heart-Assist Devices; Humans
PubMed: 35395165
DOI: 10.1146/annurev-bioeng-110220-025309 -
The Hastings Center Report Jan 2021The use of artificial organs is likely to increase in the future, given technological advances, increases in chronic diseases, and limited donor organs. This article...
The use of artificial organs is likely to increase in the future, given technological advances, increases in chronic diseases, and limited donor organs. This article examines how artificial organs could affect people's experience and conceptualization of bodies and our understanding of the relation of body to self. I focus on artificial heart devices and argue that these have two conflicting potential influences. First, they may influence people to regard the body as machinelike and separable from the self. Second, they may effect changes to subjective experience that can be understood as changes to the self, confirming the self's embodiment. My primary purpose is to increase our understanding of what might change if it becomes more usual to have a body that is partly nonorganic. But I also argue that the analysis points to potential ethical concerns related to strengthening biomedical conceptions of the body and to the devaluing of bodies and body parts.
Topics: Artificial Organs; Heart, Artificial; Humans; Morals
PubMed: 33630322
DOI: 10.1002/hast.1217 -
Artificial Organs Aug 2022Mechanical circulatory support (MCS) devices, such as ventricular assist devices (VADs) and total artificial hearts (TAHs), have become a vital therapeutic option in the... (Review)
Review
BACKGROUND
Mechanical circulatory support (MCS) devices, such as ventricular assist devices (VADs) and total artificial hearts (TAHs), have become a vital therapeutic option in the treatment of end-stage heart failure for adult patients. Such therapeutic options continue to be limited for pediatric patients. Clinicians initially adapted or scaled existing adult devices for pediatric patients; however, these adult devices are not designed to support the anatomical structure and varying flow capacities required for this population and are generally operated "off-design," which risks complications such as hemolysis and thrombosis. Devices designed specifically for the pediatric population which seek to address these shortcomings are now emerging and gaining FDA approval.
METHODS
To analyze the competitive landscape of pediatric MCS devices, we conducted a systematic literature review. Approximately 27 devices were studied in detail: 8 were established or previously approved designs, and 19 were under development (11 VADs, 5 Fontan assist devices, and 3 TAHs).
RESULTS
Despite significant progress, there is still no pediatric pump technology that satisfies the unique and distinct design constraints and requirements to support pediatric patients, including the wide range of patient sizes, increased cardiovascular demand with growth, and anatomic and physiologic heterogeneity of congenital heart disease.
CONCLUSIONS
Forward-thinking design solutions are required to overcome these challenges and to ensure the translation of new therapeutic MCS devices for pediatric patients.
Topics: Child; Extracorporeal Membrane Oxygenation; Heart Failure; Heart, Artificial; Heart-Assist Devices; Humans; Technology
PubMed: 35357020
DOI: 10.1111/aor.14242 -
Trends and outcomes following total artificial heart as bridge to transplant from the UNOS database.Journal of Cardiac Surgery May 2022Bridge to transplantation (BTT) with a SynCardia Total Artificial Heart (TAH) has been gaining momentum as a therapy for patients with biventricular heart failure....
INTRODUCTION
Bridge to transplantation (BTT) with a SynCardia Total Artificial Heart (TAH) has been gaining momentum as a therapy for patients with biventricular heart failure. Recent transplant waitlist and posttransplant outcomes with this strategy have not been comprehensively characterized. We reviewed the United Network for Organ Sharing (UNOS) database to examine BTT outcomes for the TAH system since approval.
METHODS
Adult patients listed for heart transplantation in the UNOS system between 2004 and 2020 who underwent BTT therapy with a TAH were included in the study. Trends in utilization of TAH compared with other durable mechanical support strategies were examined. The primary outcome was 1-year survival following heart transplantation following BTT with TAH. Secondary outcomes included waitlist deterioration and risk factors for waitlist or posttransplant mortality.
RESULTS
During the study 433 total patients underwent TAH implant as BTT therapy; 236 (54.4%) were listed with the TAH, while the remaining patients were upgraded to TAH support while on the waitlist. Waitlist mortality was 7.4%, with 375 patients (86.6%) ultimately being transplanted. Age, cerebrovascular disease, functional status, and ventilator dependence were risk factors for waitlist mortality. One-year survival following successful BTT was 80%. Risk factors for mortality following BTT included age, body mass index, and underlying diagnosis.
CONCLUSIONS
Patients undergoing BTT with TAH demonstrate acceptable waitlist survival and good 1-year survival. While utilization initially increased as a BTT therapy, there has been a plateau in relative utilization. Individual patient and transplantation center factors deserve further investigation to determine the ideal population for this therapy.
Topics: Adult; Heart Failure; Heart Transplantation; Heart, Artificial; Heart-Assist Devices; Humans; Retrospective Studies; Waiting Lists
PubMed: 35184312
DOI: 10.1111/jocs.16329 -
European Journal of Cardio-thoracic... Dec 2020At our centre, the SynCardia temporary Total Artificial Heart (TAH-t) (SynCardia Systems, LLC, Tucson, AZ, USA) is used to provide long-term support for patients with...
OBJECTIVES
At our centre, the SynCardia temporary Total Artificial Heart (TAH-t) (SynCardia Systems, LLC, Tucson, AZ, USA) is used to provide long-term support for patients with biventricular failure as a bridge to a transplant. However, a heart transplant (HT) after such support remains challenging. The aim of this retrospective study was to assess the immediate and long-term results following an HT in the cohort of patients who had a TAH-t implant.
METHODS
A total of 73 patients were implanted with the TAH-t between 1988 and 2019 in our centre. Of these 73 consecutive patients, 50 (68%) received an HT and are included in this retrospective analysis of prospectively collected data.
RESULTS
In the selected cohort, in-hospital mortality after an HT was 10% (n = 5). The median intensive care unit stay was 33 days (range 5-278). The median hospital stay was 41 days (range 28-650). A partial or total pericardiectomy was performed during the HT procedure in 21 patients (42%) due to a severe pericardial reaction. Long-term survival rates after an HT at 5, 10 and 12 years were 79.1 ± 5.9% (n = 32), 76.5 ± 6.3% (n = 22) and 72.4 ± 7.1% (n = 12), respectively, which was similar to the long-term survival for a primary HT without TAH-t during the same period (n = 686). An HT performed within 3-6 months post-TAH-t implantation appeared to provide the best survival (P = 0.007). Eight (16%) patients required chronic dialysis during the subsequent follow-up period, with 3 patients requiring a kidney transplant.
CONCLUSIONS
The long-term outcomes with the SynCardia TAH-t as a bridge to transplant in patients with severe biventricular failure are very encouraging. Our review noted that an HT following TAH-t can be technically challenging, especially in the case of a severe pericardial reaction, with potential pitfalls that should be recognized preoperatively.
Topics: Heart Failure; Heart Transplantation; Heart, Artificial; Humans; Retrospective Studies
PubMed: 32830239
DOI: 10.1093/ejcts/ezaa261