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BACKGROUND AND AIMS: HeartMate 3 (HM3) is a fully magnetically levitated continuous flow left ventricular assist device, which received CE marking in 2015. The ELEVATE Registry was initiated to collect real-world outcomes in patients treated with HM3 post-CE Mark approval. METHODS: A total of 540 subjects implanted at 26 centres between March 2015 and February 2017 were included in this registry. Of these, 463 received the device as a primary implant (primary implant cohort, PIC), 19 as a pump exchange (pump exchange cohort), and in 58 patients, only anonymized survival data were collected (anonymized cohort, AC). Patients in the PIC contributed to the baseline demographics, survival, adverse events, quality of life (QoL) (EuroQoL-5 Dimensions-5 Levels visual analogue scale), and functional capacity (6 min walk distance) assessments, while patients in the AC contributed only to survival. RESULTS: Primary implant cohort patients had a mean age of 56 years and were predominantly male (89%) with 48% ischaemic aetiology. The majority of subjects was designated bridge to transplant (66%) and had INTERMACS Profiles 1-3 (70%). At baseline, the subjects had poor functional capacity (104 ± 140â m) and impaired QoL (35 ± 19 points). The overall survival rate of the PIC was 63.3% and survival free of stroke was 58.1% at 5 years. Significant improvements in functional capacity and QoL were observed and maintained for 5 years (301 ± 131â m and 64 ± 20 points, respectively). CONCLUSIONS: Real-world data from the ELEVATE registry demonstrate an overall survival rate for primary implants of 63.3%. In the PIC, reductions in adverse events for patients in the extended follow-up and improved QoL and functional capacity were observed at 5 years in this patient population with advanced heart failure.
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Insuficiência Cardíaca , Coração Auxiliar , Humanos , Masculino , Pessoa de Meia-Idade , Feminino , Coração Auxiliar/efeitos adversos , Qualidade de Vida , Resultado do Tratamento , Estudos Prospectivos , Sistema de RegistrosRESUMO
Objectives. Temporary mechanical circulatory support (TMCS) has become a component in the therapeutic strategy for treatment of cardiogenic shock as a bridge-to-decision. TMCS can facilitate recovery of cardiopulmonary function, end-organ function, and potentially reduce the surgical risk of left ventricular assist device (LVAD) implantation. Despite the improvements of hemodynamics and end-organ function, post-LVAD operative morbidity might be increased in these high-risk patients. The aim of the study was to compare outcomes after Heartmate 3 (HM3) implantation in patients with and without TMCS prior to HM3 implant. Methods. In this retrospective cohort study of all HM3 patients in the period between November 2015 and October 2021, patients with and without prior TMCS were compared. Patients' demographics, baseline clinical characteristics, laboratory tests, intraoperative variables, postoperative outcomes, and adverse events were collected from patient records. Results. The TMCS group showed an improvement in hemodynamics prior to LVAD implantation. Median TMCS duration was 19.5 (14-26) days. However, the TMCS group were more coagulopathic, had more wound infections, neurological complications, and more patients were on dialysis compared with patient without TMCS prior to HM3 implantation. Survival four years after HM3 implantation was 80 and 82% in the TMCS (N = 22) and non-TMCS group (N = 41), respectively. Conclusion. Patients on TMCS had an acceptable short and long-term survival and comparable to patients receiving HM3 without prior TMCS. However, they had a more complicated postoperative course.
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Insuficiência Cardíaca , Coração Auxiliar , Hemodinâmica , Recuperação de Função Fisiológica , Choque Cardiogênico , Função Ventricular Esquerda , Humanos , Estudos Retrospectivos , Masculino , Feminino , Pessoa de Meia-Idade , Fatores de Tempo , Resultado do Tratamento , Choque Cardiogênico/fisiopatologia , Choque Cardiogênico/mortalidade , Choque Cardiogênico/terapia , Choque Cardiogênico/diagnóstico , Fatores de Risco , Adulto , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/diagnóstico , Idoso , Implantação de Prótese/instrumentação , Implantação de Prótese/efeitos adversos , Implantação de Prótese/mortalidade , Medição de Risco , Desenho de PróteseRESUMO
BACKGROUND: We conducted a single-center, retrospective comparison of adult patients who received warfarin and ASA or warfarin alone after HeartMate 3 (HM3) LVAD placement. METHODS: The primary outcome was a composite of bleeding and thrombotic events. RESULTS: Of 81 patients, 53 patients received warfarin and ASA, and 28 patients received warfarin alone. A primary outcome event occurred in 22 of 53 patients (41.4%) in the warfarin and ASA group and in 2 of 28 patients (7.1%) in the warfarin alone group (p = 0.0533). The odds of a bleeding event occurring were higher in the warfarin and ASA group (32.1% vs. 7.1%, p = 0.01309). The odds of a thrombotic event occurring were not significantly different between the warfarin and ASA group and the warfarin alone group (9.4% vs. 0%, respectively, p = 0.1582). CONCLUSION: The complete omission of ASA from the antithrombotic regimen of patients with a HM3 LVAD was associated with less bleeding events without an increase in thrombotic events.
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Insuficiência Cardíaca , Coração Auxiliar , Trombose , Adulto , Humanos , Varfarina/efeitos adversos , Aspirina/efeitos adversos , Coração Auxiliar/efeitos adversos , Estudos Retrospectivos , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Trombose/etiologia , Trombose/prevenção & controle , Insuficiência Cardíaca/cirurgia , Insuficiência Cardíaca/etiologiaRESUMO
PURPOSE: LVAD outflow graft stenosis continues to remain prevalent with a high complication rate. We sought to pool the existing evidence on indications, utilization patterns, and outcomes of transcatheter interventions for outflow graft stenosis in the HeartMate 3 LVAD. METHODS: An electronic search was performed to identify all studies in the English literature reporting on HeartMate 3 LVAD outflow graft stenting. Patient-level data were extracted for analysis. RESULTS: Thirteen published reports and one unpublished case comprising a total of 28 patients were included. Median patient age was 68.5 years [Interquartile range: 58, 71] and 25.9% (7/27) were female. Dyspnea [60.7% (17/28)] was the most common presenting symptom. Low flow alarms were present in 60% (15/25) of patients. Findings included external compression [35.7% (10/28)], graft twist [21.4% (6/28)], graft twist and external compression [14.3% (4.28)], intraluminal thrombus [10.7% (3/28)], graft twist and intraluminal thrombus [3.6% (1/28)], and pseudoaneurysm of outflow graft [3.6% (1/28)]. Median time from LVAD implantation to stenting was 2.1 years [1.4, 3]. Immediate flow normalization after stenting was observed in 85.7% (24/28). The 30-day mortality was 12% (3/25). Overall mortality was 12% (3/25) at a median follow-up of 3.9 months [1, 17]. CONCLUSION: Outflow graft stenting in the HeartMate 3 LVAD appears to be a reasonable treatment option for outflow graft stenosis, with low overall rates of complications and mortality. Further refinement of indications and approaches may improve outcomes.
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Coração Auxiliar , Stents , Humanos , Coração Auxiliar/efeitos adversos , Stents/efeitos adversos , Resultado do Tratamento , Insuficiência Cardíaca/cirurgia , Feminino , Pessoa de Meia-Idade , Idoso , MasculinoRESUMO
Heart failure (HF) remains a public health concern affecting millions of individuals worldwide. Despite recent advances in device-related therapies, the prognosis for patients with chronic HF remains poor with significant long-term risk of morbidity and mortality. Left ventricular assist devices (LVADs) have transformed the landscape of advanced HF management, offering circulatory support as destination therapy or as a bridge for heart transplantation. Among the latest generation of LVADs, the HeartMate 3 has gained popularity due to improved clinical outcomes and lower risk of serious adverse events when compared with previous similar devices. The ELEVATE (Evaluating the HeartMate 3 with Full MagLev Technology in a Post-Market Approval Setting) Registry and the MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) trial represent landmark investigations into the performance and comparative effectiveness of the HeartMate 3 LVAD. This review provides a comprehensive synthesis of the safety and efficacy of the 2-year and 5-year HeartMate LVAD outcomes, highlighting key findings, methodological considerations, implications for clinical practice, and future directions.
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A 31-year-old man with a HeartMate 3 was admitted with a "Driveline Communication Fault" alarm due to liquid infiltration. Eleven months earlier, the connector between the modular and pump cables had gotten wet when he was taking a shower. The cable connector was dried immediately, and no alarm had been observed during follow-up. Subsequently, the modular cable and system controller were replaced, with corrosion found on the modular cable connector. The "Communication Fault" alarm recurred, and complete damage to the communication cables was discovered. The pump was replaced, and the removed pump cable connector showed corrosion as well. If the driveline connector gets wet, the multidisciplinary team should discuss if it should be immediately disconnected and dried, averting the need for future pump replacements due to corrosion.
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Heart failure with reduced ejection fraction (HFrEF) is a complex clinical syndrome with significant morbidity and mortality and seems to be responsible for approximately 50% of heart failure cases and hospitalizations worldwide. First-line treatments of patients with HFrEF, according to the ESC and AHA guidelines, include ß-blockers, angiotensin receptor/neprilysin inhibitors, sodium-glucose cotransporter 2 inhibitors, and mineralocorticoid receptor antagonists. This quadruple therapy should be initiated during hospital stay and uptitrated to maximum doses within 6 weeks after discharge according to large multicenter controlled trials. Quadruple therapy improves survival by approximately 8 years for a 55-year-old heart failure patient. Additional therapeutic strategies targeting other signaling pathways such as ivabradine, digoxin, and isosorbide dinitrate and hydralazine combination for African Americans, as well as adjunctive symptomatic therapies, seem to be necessary in the management of HFrEF. Although second-line medications have not achieved improvements in mortality, they seem to decrease heart failure hospitalizations. There are novel medical therapies including vericiguat, omecamtiv mecarbil, genetic and cellular therapies, and mitochondria-targeted therapies. Moreover, mitraclip for significant mitral valve regurgitation, ablation in specific atrial fibrillation cases, omecamtiv mecarbil are options under evaluation in clinical trials. Finally, the HeartMate 3 magnetically levitated centrifugal left ventricular assist device (LVAD) has extended 5-year survival for stage D HF patients who are candidates for an LVAD.
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Insuficiência Cardíaca , Ureia/análogos & derivados , Humanos , Volume Sistólico , Hidralazina/farmacologia , Hidralazina/uso terapêutico , Dinitrato de Isossorbida/farmacologia , Dinitrato de Isossorbida/uso terapêutico , Antagonistas de Receptores de Angiotensina/farmacologia , Estudos Multicêntricos como AssuntoRESUMO
Despite the withdrawal of the HeartWare Ventricular Assist Device (HVAD), hundreds of patients are still supported with this continuous-flow pump, and the long-term management of these patients is still under debate. This study aims to analyse 5 years survival and freedom from major adverse events in patients supported by HVAD and HeartMate3 (HM3). From 2010 to 2022, the MIRAMACS Italian Registry enrolled all-comer patients receiving a LVAD support at seven Cardiac Surgery Centres. Out of 447 LVAD implantation, 214 (47.9%) received HM3 and 233 (52.1%) received HVAD. Cox-regression analysis adjusted for major confounders showed an increased risk for mortality (HR 1.5 [1.2-1.9]; p = 0.031), for both ischemic stroke (HR 2.08 [1.06-4.08]; p = 0.033) and haemorrhagic stroke (HR 2.6 [1.3-4.9]; p = 0.005), and for pump thrombosis (HR 25.7 [3.5-188.9]; p < 0.001) in HVAD patients. The propensity-score matching analysis (130 pairs of HVAD vs. HM3) confirmed a significantly lower 5 years survival (81.25% vs. 64.1%; p 0.02), freedom from haemorrhagic stroke (90.5% vs. 70.1%; p < 0.001) and from pump thrombosis (98.5% vs. 74.7%; p < 0.001) in HVAD cohort. Although similar perioperative outcome, patients implanted with HVAD developed a higher risk for mortality, haemorrhagic stroke and thrombosis during 5 years of follow-up compared to HM3 patients.
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Coração Auxiliar , Acidente Vascular Cerebral Hemorrágico , Humanos , Sistema de Registros , Pontuação de Propensão , Fenômenos MagnéticosRESUMO
[This corrects the article DOI: 10.3389/ti.2023.11675.].
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BACKGROUND: We evaluated the impact of a standardized driveline care strategy, including a subfascial-tunneling method and dressing protocol, on the incidence of driveline infection (DLI). METHODS: DLI data from all HeartMate II (HMII) and HeartMate 3 (HM3) patients (including exchange devices) were retrospectively collected between 2013 and 2021. The driveline subfascial-tunneling method was altered in three steps (A: right direct; B: left triple, C: right triple), and the shower protocol was changed in two steps (A: with/without cover, B: with cover). Disinfection was individually tailored after changing the shower protocol. Complications associated with morbidity and mortality were evaluated for each modification. RESULTS: During the study period, 80 devices were implanted (HMII, n = 54; HM3, n = 26). The 8-year incidence of DLI was 15% (n = 8) in HMII patients and 0% in HM3 patients (p = 0.039). DLI was not associated with hospital mortality. The modified dressing protocol and tunneling method was associated with a significantly better DLI incidence rate in comparison to the previous one: Protocol-A (n = 17), Protocol-B (n = 63), 35% vs 3% (p = 0.0009), Method-A (n = 13), Method-B (n = 42), Method-C (n = 25), 46% vs 5% vs 0% (p = 0.0001). The rete of freedom form DLI at 1, 2, and 3 years had also significant difference between groups: Protocol-A and Protocol-B, 80%, 54%, 54% vs 96%, 96%, 96%, respectively (p < 0.0001), Method-A, Method-B and Method-C, 76%, 44%, 44%, vs 94%, 94%, 94% vs 100%, 100%, respectively (p < 0.0001). CONCLUSIONS: A standardized triple driveline tunneling strategy and waterproof dressing protocol reduced driveline infection in HM3 patients to 0%.
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Insuficiência Cardíaca , Coração Auxiliar , Infecções Relacionadas à Prótese , Humanos , Estudos Retrospectivos , Coração Auxiliar/efeitos adversos , Insuficiência Cardíaca/cirurgia , Insuficiência Cardíaca/complicações , Incidência , Bandagens/efeitos adversos , Infecções Relacionadas à Prótese/epidemiologia , Infecções Relacionadas à Prótese/etiologia , Infecções Relacionadas à Prótese/prevenção & controleRESUMO
Blood flow obstruction at the level of the outflow graft is a rare but severe complication of LVAD support. We present a series of five patients supported with HeartMate3 LVAD (Abbott Labs, Chicago, IL) that developed an outflow graft obstruction after 607-1250 days of support, during prolonged antithrombotic therapy. Three patients presented with severe symptoms of heart failure, were treated with endovascular stenting and experienced full recovery. Preoperative computed tomography angiography and intraoperative angiography together with intravascular ultrasound provided diagnosis and guided treatment. In two patients, outflow obstruction was an occasional finding at imaging without heart failure symptoms and a "watchful waiting" approach was adopted: delayed treatment in one of them was futile. This late adverse event is peculiar for its pathophysiology and not yet discussed among the mechanical circulatory support community.
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Cardiopatias , Insuficiência Cardíaca , Coração Auxiliar , Humanos , Coração Auxiliar/efeitos adversos , Insuficiência Cardíaca/cirurgia , Tomografia Computadorizada por Raios X , ChicagoRESUMO
BACKGROUND: Driveline (DL) damages are a common difficulty among ventricular assist devices (VAD). Repairing the electrical fibers inside the DL on a running pump is hazardous and requires technical expertise, which is not easily available on site. A new feature of the HeartMate3 (Abbott, U.S.A.) LVAD is a modular driveline that allows an easy exchange of the DL cord. In this report we analyze our experiences with this feature. METHODS: We performed a retrospective analysis of 302 patients who underwent either HeartMate II or HeartMate 3 implantation between February 2004 and September 2021. Patients were screened for driveline faults and need for exchange or repair of driveline or VAD exchange. Documented were baseline characteristics, reasons for DL or VAD exchange, and complications. Follow-up was three months after the procedure. RESULTS: We present a cohort of 302 patients who underwent either HMII (n = 107;35.4%) or HM 3 (n = 195; 64.5%) implantation. Out of those, 40 patients (40/302; 13.2%) required driveline repair (DLRe) or exchange (DLEx). Out of 107 HMII patients, 9 showed severe DL damages (9/107; 8.4%). Six patients (6/9; 66.6%) underwent DLRe, two patients (2/6; 33.3%) required VAD exchange after DLRe, one patient (1/2;50%) experienced emergency VAD exchange after pump stop. The DLRe procedure in the other four patients (4/6; 66.6%) was successful. Due to damage to the internal driveline two patients (2/9; 22.2%) underwent emergency device exchange and one patient (1/9;11.1%) was listed for transplantation. 31 out 195 HM3 patients underwent exchange of the modular DL. In none of the cases, damages of the internal fibers were the reasons for the exchange. In 100% of the cases, damages of the external coating were the reason for DL exchange. In none of the cases, complications occurred after the exchange procedure. CONCLUSIONS: Driveline damages are a habitual, recurrent complication in VAD patients. The exchange of the modular driveline cable of the HM3 is feasible and safe compared to the conventional DL repair in HMII patients. Risky repair attempts and surgical LVAD exchange due to major damages of the electrical fibers can be avoided successfully by the new feature of HM3 driveline.
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Insuficiência Cardíaca , Transplante de Coração , Coração Auxiliar , Humanos , Insuficiência Cardíaca/cirurgia , Insuficiência Cardíaca/etiologia , Estudos Retrospectivos , Coração Auxiliar/efeitos adversosRESUMO
BACKGROUND: In patients with left ventricular assist devices (LVADs), ischemic and hemorrhagic stroke are dreaded complications. Predictive markers for these events are lacking. This study aimed to investigate the prevalence and predictive value of microembolic signals (MES) for stroke, detected by Transcranial Doppler sonography (TCD) in patients with HeartMate 3 (HM 3) or HeartWare (HW). METHODS: A thirty-minute bilateral TCD monitoring of the middle cerebral artery (MCA) was performed in 62 outpatients with LVAD (HM 3 N = 31, HW N = 31) and 31 healthy controls. Prevalence and quantity of MES were investigated regarding clinical and laboratory parameters. Cerebrovascular events (CVE) were recorded on follow-up at 90 and 180 days. RESULTS: MES were detected in six patients with HM 3, three patients with HW, and three controls. Within the LVAD groups, patients on monotherapy with vitamin-K-antagonist (VKA) without antiplatelet therapy were at risk for a higher count of MES (negative binomial regression: VKA: 1; VKA + ASA: Exp(B) = 0.005, 95%CI 0.001-0.044; VKA + clopidogrel: Exp(B) = 0.012, 95%CI 0.002-0.056). There was no association between the presence of MES and CVE or death on follow-up (p > 0.05). CONCLUSION: For the first time, the prevalence of MES was prospectively investigated in a notable outpatient cohort of patients with HM 3 and HW. Despite optimized properties of the latest LVAD, MES remain detectable depending on antithrombotic therapy. No association between MES and CVE could be detected.
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Coração Auxiliar , Acidente Vascular Cerebral , Humanos , Fibrinolíticos/efeitos adversos , Acidente Vascular Cerebral/etiologia , Anticoagulantes/uso terapêutico , Clopidogrel , Coração Auxiliar/efeitos adversos , Ultrassonografia Doppler TranscranianaRESUMO
Patient-tailored silicone plug for HeartMate 3™ left ventricular assist device explantation in two successive males proceeded successfully. Given medical therapeutic advancements, FDA-approved plug systems designed by LVAD manufacturers themselves will be necessary for the near future to provide a safe and simple device explantation alternative that fulfills all regulatory standards.
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Implantation of left ventricular assist device (LVAD) for arrhythmogenic right ventricular (RV) cardiomyopathy is challenging associated with small LV cavity, laterally dislocated LV apex, thin and fragile RV free wall. A 43-year-old male with more than 10 years of medical treatment developed congestive heart failure related to biventricular failure. Durable LVAD was indicated to prevent further deterioration of the RV function, which would be exacerbated by progression of LV dysfunction. To simulate surgery, we printed-out a 3D heart model based on enhanced CT scanning study to identify the optimal coring position in the LV apex, by which the inflow directs the mitral valve. We then found that the mini-cuff of the HeartMate3 should be fixed in the paper-thin RV free wall by the usual cuff-sewing method. In the surgery, after the coring as planned, 5 pairs of interrupted sutures on the medial side were passed from the luminal side of the LV and then to the mini-cuff, and the lateral side of the mini-cuff was fixed with a continuous sutures, not to sew into the RV wall. The surgery was completed without complications with a good hemodynamics. The 3D heart model facilitated this unique method, indicating a usefulness of printed-out heart model for cases with unusual cardiac anatomy, which needs implantation of durable LVAD.
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Displasia Arritmogênica Ventricular Direita , Insuficiência Cardíaca , Coração Auxiliar , Disfunção Ventricular Esquerda , Disfunção Ventricular Direita , Masculino , Humanos , Adulto , Displasia Arritmogênica Ventricular Direita/cirurgia , Displasia Arritmogênica Ventricular Direita/complicações , Coração Auxiliar/efeitos adversos , Insuficiência Cardíaca/cirurgia , Disfunção Ventricular Esquerda/complicações , Ventrículos do Coração/diagnóstico por imagem , Ventrículos do Coração/cirurgia , Disfunção Ventricular Direita/etiologia , Função Ventricular DireitaRESUMO
BACKGROUND: As left ventricular assist device (LVAD) survival rates continue to improve, evaluating site-specific variability in outcomes can facilitate identifying targets for quality-improvement initiative opportunities in the field. METHODS: Deidentified center-specific outcomes were analyzed for HeartMate 3 (HM3) patients enrolled in the MOMENTUM 3 pivotal and continued access protocol trials. Centers < 25th percentile for HM3 volumes were excluded. Variability in risk-adjusted center mortality was assessed at 90 days and 2 years (conditional upon 90-day survival). Adverse event (AE) rates were compared across centers. RESULTS: In the 48 included centers (1958 patients), study-implant volumes ranged between 17 and 106 HM3s. Despite similar trial-inclusion criteria, patient demographics varied across sites, including age quartile ((Q)1-Q3:57-62 years), sex (73%-85% male), destination therapy intent (60%-84%), and INTERMACS profile 1-2 (16%-48%). Center mortality was highly variable, nadiring at ≤ 3.6% (≤ 25th percentile) and peaking at ≥ 10.4% (≥ 75th percentile) at 90 days and ≤ 10.2% and ≥ 18.7%, respectively, at 2 years. Centers with low mortality rates tended to have lower 2-year AE rates, but no center was a top performer for all AEs studied. CONCLUSIONS: Mortality and AEs were highly variable across MOMENTUM 3 centers. Studies are needed to improve our understanding of the drivers of outcome variability and to ascertain best practices associated with high-performing centers across the continuum of intraoperative to chronic stages of LVAD support.
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Insuficiência Cardíaca , Coração Auxiliar , Feminino , Insuficiência Cardíaca/cirurgia , Coração Auxiliar/efeitos adversos , Humanos , Masculino , Taxa de Sobrevida , Resultado do TratamentoRESUMO
Advanced heart failure is a clinical challenge that requires a pathophysiological-based approach. As the field has been the subject of multiple reviews, the objective of this paper is not to duplicate these publications but rather to offer practical tips for the clinical cardiologist to enable the optimal management of patients with advanced heart failure. Advanced heart failure is defined as a clinical syndrome characterized by severe and persistent symptoms, most commonly with severe ventricular dysfunction, despite optimized medical therapy. This review covers the management of the advanced heart failure patient from pharmacologic therapy with disease-modifying drugs, to the use of electrical therapy devices, percutaneous valve repair and finally to the role of left ventricular assist devices and heart transplantation. The review also explores future directions in the management of advanced heart failure, including translational perspectives for the treatment of this syndrome.
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Insuficiência Cardíaca , Transplante de Coração , Coração Auxiliar , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Transplante de Coração/efeitos adversos , Ventrículos do Coração , HumanosRESUMO
Left-ventricular assist devices (LVADs) improve outcomes in end-stage heart failure patients. Two centrifugal-flow LVAD systems are currently approved, HeartMate 3 (HM3) and Medtronic/Heartware HVAD (HVAD). Clinical findings suggest differences in thrombogenicity between both systems. We compared markers of platelet activation and aggregation between HM3 and HVAD. We prospectively included 59 LVAD patients (40 HM3, 19 HVAD). Platelet P-selectin expression, activated glycoprotein (GP) IIb/IIIa and monocyte-platelet aggregates (MPA) were assessed by flow-cytometry. Platelet aggregation was measured by light-transmission aggregometry (LTA) and multiple-electrode aggregometry (MEA). Von-Willebrand factor (VWF) antigen (VWF:Ag), VWF activity (VWF:Ac), and VWF multimer pattern analysis were determined. Soluble P-selectin (sP-selectin) was measured with an enzyme-linked immunoassay. P-selectin, GPIIb/IIIa and MPA levels in vivo and in response to arachidonic acid, adenosine diphosphate, and thrombin receptor activating peptide were similar between HM3 and HVAD (all p > .05). Likewise, agonist-inducible platelet aggregation by LTA and MEA did not differ between HM3 and HVAD (all p > .05). VWF:Ag levels and FVIII:C were similar between both systems (both p > .05), but patients with HVAD had significantly lower VWF:Ac (p = .011) and reduced large VWF multimers (p = .013). Finally, sP-selectin levels were similar in patients with HVAD and HM3 (p = .845). In conclusion, on-treatment platelet activation and aggregation are similar in HM3 and HVAD patients. Potential clinical implications of observed differences in VWF profiles between both LVAD systems need to be addressed in future clinical trials.
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Coração Auxiliar/normas , Ativação Plaquetária/fisiologia , Agregação Plaquetária/fisiologia , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
The resolution of functional mitral valve regurgitation (MR) in patients awaiting left ventricular assist device (LVAD) implantation is discussed controversially. The present study analyzed MR and echocardiographic parameters of the third-generation LVAD HeartMate 3 (HM3) over 3 years. Of 135 LVAD patients (with severe MR, n = 33; with none, mild, or moderate MR, n = 102), data of transthoracic echocardiography were included preoperatively to LVAD implantation, up to 1 month postoperatively, and at 1, 2, and 3 years after LVAD implantation. Demographic data and clinical characteristics were collected. Severe MR was reduced immediately after LVAD implantation in all patients. The echocardiographic parameters left ventricular end-diastolic diameter (P < .001), right ventricular end-diastolic diameter (P < .001), tricuspid annular plane systolic excursion (P < .001), and estimated pulmonary artery pressure (P < .001) decreased after HM3 implantation independently from the grade of MR prior to implantation and remained low during the 2 years follow-up period. Following LVAD implantation, right heart failure, ventricular arrhythmias, ischemic stroke as well as pump thrombosis and bleeding events were comparable between the groups. The incidences of death and cardiac death did not differ between the patient groups. Furthermore, the Kaplan-Meier analysis showed that survival was comparable between the groups (P = .073). HM3 implantation decreases preoperative severe MR immediately after LVAD implantation. This effect is long-lasting in most patients and reinforces the LVAD implantation without MR surgery. The complication rates and survival were comparable between patients with and without severe MR.
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Insuficiência Cardíaca/terapia , Coração Auxiliar , Insuficiência da Valva Mitral/fisiopatologia , Adulto , Ecocardiografia , Feminino , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/patologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Insuficiência da Valva Mitral/diagnóstico por imagem , Implantação de Prótese , Resultado do Tratamento , Disfunção Ventricular Esquerda/terapiaRESUMO
Systemic right ventricular failure after physiologic repair for dextro-transposition of the great arteries can be managed with durable mechanical circulatory support; however, the right ventricular morphology, such as intervening papillary muscles, presents challenges to inflow cannula positioning. Papillary muscle repositioning is an innovative technique to circumvent obstructive anatomy.