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Considerations on Enhancing Venoarterial-Extracorporeal Membrane Oxygenation Via Transapical Cannulation and Minimally Invasive Techniques. 经根尖插管和微创技术增强静脉-体外膜氧合的思考。
IF 3.1 3区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2024-11-20 DOI: 10.1097/MAT.0000000000002354
Ignazio Condello
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引用次数: 0
Harvi Cardiovascular Modeling Accurately Predicts Hemodynamic Improvements Produced by a New Direct Cardiac Compression Device. 哈维心血管模型准确预测了一种新的直接心脏压迫装置所产生的血液动力学改善。
IF 3.1 3区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2024-11-19 DOI: 10.1097/MAT.0000000000002346
Erica C Perez, Christina M Bolch, Reagan M Tompkins, Daniel Burkhoff, George V Letsou, John C Criscione

Despite advancements in mechanical circulatory support (MCS) technology, persistent critical complications related to blood contact remain unresolved. To provide a safer alternative therapy, CorInnova is developing a non-blood contacting direct cardiac compression (DCC) device for MCS. To support product development toward clinical trials, a simulation platform has been developed to predict clinical outcomes under patient-specific conditions, guiding patient selection for clinical trials. The Harvi simulation was validated using preclinical in vivo data from experimental studies with the CorInnova device, with n = 28 hemodynamic samples simulated from animal data (n = 4 ovine). After confirming validation, further simulation was performed to predict additional hemodynamic outcomes not captured in animal studies. The simulated effects of CorInnova device therapy were not significantly different from animal data for cardiac output, systemic arterial blood pressure, mean pulmonary artery pressure, central venous pressure, or left ventricular pressure (p > 0.050). Harvi accurately predicts the effects of the CorInnova device in heart failure conditions and can be used in preparation for future clinical trials.

尽管机械循环支持(MCS)技术取得了进步,但与血液接触相关的持续严重并发症仍未得到解决。为了提供更安全的替代疗法,CorInnova正在开发一种用于MCS的非血液接触直接心脏压迫(DCC)装置。为了支持临床试验的产品开发,开发了一个模拟平台来预测患者特定情况下的临床结果,指导临床试验的患者选择。利用CorInnova设备实验研究的临床前体内数据验证了Harvi模拟,并从动物数据中模拟了n = 28个血液动力学样本(n = 4只羊)。在确认验证后,进行进一步的模拟以预测在动物研究中未捕获的其他血流动力学结果。CorInnova装置治疗的模拟效果在心输出量、全身动脉血压、平均肺动脉压、中心静脉压或左心室压方面与动物数据没有显著差异(p > 0.050)。哈维准确地预测了CorInnova设备对心力衰竭的影响,并可用于为未来的临床试验做准备。
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引用次数: 0
Survival and Neurocognitive Outcomes After Noncardiac Illness Indications for Extracorporeal Membrane Oxygenation in Young Children. 幼儿体外膜氧合适应症非心脏疾病后的生存和神经认知结果。
IF 3.1 3区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2024-11-18 DOI: 10.1097/MAT.0000000000002344
Lauren A Ryan, Gwen Y Bond, Sara Khademioureh, Irina A Dinu, Don Granoski, Laurance Lequier, Charlene M T Robertson, Ari R Joffe

This referral center prospective inception cohort study included 84 consecutive children having extracorporeal membrane oxygenation (ECMO) for noncardiac illness indications at the age of less than 6 years from 2000 to 2017. Long-term outcomes were survival, neurocognitive (Wechsler Preschool and Primary Scales of Intelligence) and functional (General Adaptive Composite) scores, and disability, with optimal outcome defined as scores greater than or equal to 80 and without disability. Age at cannulation was 551 (standard deviation [SD] = 571) days, 40 (47.6%) were male, 12 (14.3%) had known chromosomal abnormality, and 15 (17.9%) had nonchromosomal congenital abnormality. Survival was 45 (53.6%) to hospital discharge, and 41 (48.8%) to age 6 years. In 40/41 (97.6%) survivors with follow-up, at mean age of 56.1 (SD = 5.1) months, neurocognitive and functional scores were shifted to the left, with 30-42.5% having a score greater than 2 SD below population norms. Optimal outcome occurred in 11/40 (27.5%) survivors, and 11/84 (13.1%) overall. On multiple regression full-scale intelligence quotient was associated with longer time in pediatric intensive care unit (PICU) pre-ECMO (OR per hour -0.02, 95% confidence interval [CI] = -0.03 to -0.01; p = 0.005), known chromosomal abnormality (odds ratio [OR] = -18.99, 95% CI = -29.04 to -8.04; p = 0.001), and seizure pre-ECMO (OR = -17.00, 95% CI = -30.00 to -4.00; p = 0.012). Predictors of mortality included peak lactate on ECMO and nonchromosomal congenital abnormality. Findings may help with ECMO decision-making and counseling.

这项转诊中心前瞻性初始队列研究纳入了2000年至2017年期间84名连续接受体外膜氧合(ECMO)治疗非心脏疾病适应症的年龄小于6岁的儿童。长期结果包括生存、神经认知(韦氏学前和初级智力量表)和功能(一般适应性综合量表)得分和残疾,最佳结果定义为得分大于或等于80且无残疾。插管时年龄551天(标准差[SD] = 571),男性40例(47.6%),已知染色体异常12例(14.3%),非染色体先天性异常15例(17.9%)。存活45例(53.6%)至出院,41例(48.8%)至6岁。在随访的40/41(97.6%)幸存者中,平均年龄为56.1 (SD = 5.1)个月,神经认知和功能评分向左偏移,其中30-42.5%的评分比总体标准低2个SD以上。11/40(27.5%)的幸存者和11/84(13.1%)的总体预后最佳。在多元回归中,全量表智商与儿童重症监护病房(PICU) ecmo前时间较长相关(OR / h -0.02, 95%可信区间[CI] = -0.03 ~ -0.01;p = 0.005),已知染色体异常(优势比[OR] = -18.99, 95% CI = -29.04 ~ -8.04;p = 0.001), ecmo前癫痫发作(OR = -17.00, 95% CI = -30.00 ~ -4.00;P = 0.012)。死亡率预测因子包括ECMO时乳酸峰值和非染色体先天性异常。结果可能有助于ECMO的决策和咨询。
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引用次数: 0
Prosthetic Valve Fate in Patients With Continuous-Flow Left Ventricular Assist Devices. 持续流左心室辅助装置患者的人工瓣膜命运。
IF 3.1 3区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2024-11-12 DOI: 10.1097/MAT.0000000000002345
Daisuke Kaneyuki, Krushang Patel, Alice V Vinogradsky, Kavya Rajesh, Melissa A Hynds, Paul A Kurlansky, Melana Yuzefpolskaya, Paolo C Colombo, Gabriel T Sayer, Nir Uriel, Yoshifumi Naka, Koji Takeda

Prosthetic valve-related morbidity and mortality in patients with left ventricular assist devices (LVADs) remain unclear. We retrospectively reviewed patients who received a HeartMate II or 3 LVAD at our center between April 2004 and December 2022. Patients with a valve prosthesis in any position were included. Of the 726 LVAD recipients, 74 (10.2%) underwent valve replacement before (n = 37, 50.0%), concomitantly with (n = 32, 43.2%), or after (n = 6, 8.1%) LVAD insertion. Prosthetic valves were implanted in the aortic (n = 32), mitral (n = 23), and tricuspid (n = 26) positions. Mechanical valves were present in eight (three aortic, five mitral) patients. At a median follow-up of 1.97 years post-VAD (interquartile range [IQR]: 0.56-4.58 years), there was one valve-related death due to severe aortic bioprosthetic insufficiency. Five of 28 (17.9%) patients with an aortic bioprosthesis had evidence of dysfunction on follow-up echocardiography. Median time to first sign of aortic bioprosthetic valve dysfunction was 1 (IQR: 0.6-5.1) year from time of LVAD with the prosthesis in place and 10.8 (IQR: 9.5-12.6) years from date of initial valve insertion. Prosthetic valve-related mortality or reinterventions are uncommon in patients with LVADs; however, bioprosthetic aortic valve dysfunction can develop less than 1 year after LVAD implantation.

左心室辅助装置(LVAD)患者与人工瓣膜相关的发病率和死亡率仍不清楚。我们对 2004 年 4 月至 2022 年 12 月期间在本中心接受 HeartMate II 或 3 LVAD 的患者进行了回顾性研究。我们纳入了在任何位置安装了瓣膜假体的患者。在 726 名 LVAD 接受者中,74 人(10.2%)在植入 LVAD 之前(37 人,50.0%)、同时(32 人,43.2%)或之后(6 人,8.1%)接受了瓣膜置换术。人工瓣膜分别植入主动脉(32 例)、二尖瓣(23 例)和三尖瓣(26 例)。8例患者(3例主动脉瓣,5例二尖瓣)植入了机械瓣膜。在 VAD 术后 1.97 年(四分位数间距 [IQR]:0.56-4.58 年)的中位随访中,有一名患者因严重的主动脉生物假体功能不全而死于瓣膜相关疾病。28名使用主动脉生物假体的患者中有5名(17.9%)在随访超声心动图检查中发现功能障碍。首次出现主动脉生物假体瓣膜功能障碍的中位时间为 1 年(IQR:0.6-5.1),从植入假体的 LVAD 开始算起;10.8 年(IQR:9.5-12.6),从首次植入瓣膜开始算起。在使用 LVAD 的患者中,与人工瓣膜相关的死亡或再干预并不常见;但是,在 LVAD 植入后不到 1 年的时间内,就会出现生物人工主动脉瓣功能障碍。
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引用次数: 0
Heart Transplantation Outcomes in Patients With Hypertrophic Cardiomyopathy in the Era of Mechanical Circulatory Support. 机械循环支持时代肥厚型心肌病患者的心脏移植结果。
IF 3.1 3区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2024-11-11 DOI: 10.1097/MAT.0000000000002347
Matylda Mazur, Robert Dowling, Geetha Bhat, Andres Carmona Rubio, Howard J Eisen

Mechanical circulatory support has emerged as a vital therapeutic modality for patients awaiting heart transplantation (HT). However, it is unknown how it affected the characteristics and post-HT outcomes of patients with hypertrophic cardiomyopathy (HCM). This retrospective cohort study analyzed adult HT recipients from the International Society for Heart and Lung Transplantation registry (1998-2017). Two equal-duration eras were defined: era 1 1998-2007 and era 2 2008-2017. Patients with HCM were compared across the two eras (n1 = 742 and n2 = 1,211) and within each era, they were contrasted with individuals with nonischemic (NICM) (n1 = 15,964 and n2 = 20,394) and ischemic cardiomyopathy (ICM) (n1 = 14,140 and n2 = 12,986). Across eras, the number of HTs among patients with HCM increased by 63%. The rate of recipients with HCM in the intensive care unit (ICU) supported with intra-aortic balloon pump (IABP) increased, yet their pre-HT functional status improved, and 5 year post-HT survival remained unchanged and favorable. In era 2, at the time of HT, patients with HCM were more frequently than their NICM and ICM counterparts in the ICU and supported with inotropes. In the same era, 1 and 5 year survival were more favorable in HCM compared to ICM and comparable to NICM.

机械循环支持已成为等待心脏移植(HT)患者的重要治疗方式。然而,机械循环支持如何影响肥厚型心肌病(HCM)患者的特征和心脏移植后的预后还不得而知。这项回顾性队列研究分析了来自国际心肺移植学会登记处(1998-2017 年)的成年心脏移植受者。研究界定了两个时间相等的时代:1998-2007 年的时代 1 和 2008-2017 年的时代 2。两个时代的 HCM 患者进行了比较(n1 = 742,n2 = 1,211),并在每个时代内与非缺血性(NICM)(n1 = 15,964,n2 = 20,394)和缺血性心肌病(ICM)(n1 = 14,140,n2 = 12,986)患者进行了对比。在不同时期,HCM 患者的 HT 数量增加了 63%。在重症监护病房(ICU)接受主动脉内球囊反搏泵(IABP)支持的 HCM 患者比例增加,但他们在 HT 术前的功能状态有所改善,HT 术后 5 年的生存率保持不变,而且情况良好。在第 2 个时代,HT 时,HCM 患者比 NICM 和 ICM 患者更常入住 ICU 并接受肌力支持。在同一时期,HCM 患者的 1 年和 5 年存活率比 ICM 患者更高,与 NICM 患者相当。
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引用次数: 0
Reply Letter to Editor to Daniel Schneditz. 给编辑丹尼尔-施内迪茨的回信。
IF 3.1 3区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2024-11-06 DOI: 10.1097/MAT.0000000000002336
Dilek Karacanoğlu, Benan Bayrakci
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引用次数: 0
Predictive Accuracy of HeartMate 3 Risk Score After the Heart Transplant Allocation Change. 心脏移植分配变化后 HeartMate 3 风险评分的预测准确性。
IF 3.1 3区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2024-11-06 DOI: 10.1097/MAT.0000000000002343
Justin D Vincent, Alyssa Ramsay, David S Lambert, Elena Deych, Ana María Pico, Erin Coglianese, Justin M Vader, Bin Q Yang

The HeartMate 3 risk score (HM3RS) was developed from the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) clinical trial to predict 1 and 2 year mortality after left ventricular assist device implantation. However, it has not been validated in a real-world population, especially after the heart transplant allocation system change on October 18, 2018. In this multicenter retrospective analysis, we found that HM3RS did not predict 1 and 2 year outcomes in the contemporary era, highlighting the need to revise this risk prediction tool in the real-world setting.

HeartMate 3风险评分(HM3RS)是根据MagLev技术在接受HeartMate 3机械循环支持治疗患者中的多中心研究(MOMENTUM 3)临床试验开发的,用于预测左心室辅助装置植入术后1年和2年的死亡率。然而,该技术尚未在现实世界人群中得到验证,尤其是在 2018 年 10 月 18 日心脏移植分配系统变更之后。在这项多中心回顾性分析中,我们发现 HM3RS 在当代并不能预测 1 年和 2 年的预后,这凸显了在真实世界环境中修订这一风险预测工具的必要性。
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引用次数: 0
New Right Ventricular Dysfunction in Pediatric Acute Respiratory Distress Syndrome on Venovenous Extracorporeal Membrane Oxygenation. 静脉体外膜氧合治疗小儿急性呼吸窘迫综合征的新右心室功能障碍。
IF 3.1 3区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2024-11-01 Epub Date: 2024-06-19 DOI: 10.1097/MAT.0000000000002257
Caroline Holton, Sanket Shah, Jenna O Miller

The development of new right ventricular (RV) dysfunction after cannulation to venovenous (VV) extracorporeal membrane oxygenation (ECMO) and its association with worse outcomes is increasingly recognized in adult patients, however, no studies have evaluated this phenomenon in pediatric patients. We report results of a single-center retrospective cohort study at a large academic children's hospital. New RV systolic dysfunction was present in 48% (12/25) of pediatric patients on VV ECMO for acute respiratory distress syndrome (ARDS). There was no statistically significant difference in survival, duration of mechanical ventilation, or hospital length of stay between those with and without RV dysfunction. Over half (5/9, 56%) of survivors with RV dysfunction on ECMO had RV dilation or RV hypertrophy on post-ECMO echocardiograms, and in two patients the RV dysfunction persisted for months following decannulation. Cardiac catheterization and autopsy reports suggested that echocardiographic assessment of RV systolic function alone may not be sufficient to diagnose clinically relevant RV injury. This is the first study to report the prevalence of RV dysfunction on VV ECMO for pediatric ARDS. Future multicenter collaboration is needed to create a clinically relevant definition of pediatric "RV injury" and to further evaluate risk factors and outcomes of RV dysfunction.

在成人患者中,越来越多的人认识到静脉体外膜肺氧合(ECMO)插管后会出现新的右心室(RV)功能障碍,而且这种情况与更差的预后有关,但还没有研究对儿科患者的这种现象进行评估。我们报告了在一家大型儿童学术医院进行的单中心回顾性队列研究的结果。在因急性呼吸窘迫综合征(ARDS)而接受 VV ECMO 的儿科患者中,48%(12/25)的患者出现了新的 RV 收缩功能障碍。在存活率、机械通气时间或住院时间方面,存在和不存在 RV 功能障碍的患者没有明显的统计学差异。半数以上(5/9,56%)接受 ECMO 的 RV 功能障碍幸存者在 ECMO 后超声心动图检查中出现 RV 扩张或 RV 肥厚,其中两名患者的 RV 功能障碍在解禁后持续数月。心导管检查和尸检报告表明,仅凭超声心动图评估 RV 收缩功能可能不足以诊断临床相关的 RV 损伤。这是首个报告小儿 ARDS VV ECMO 中 RV 功能障碍发生率的研究。未来需要开展多中心合作,为儿科 "RV 损伤 "制定临床相关定义,并进一步评估 RV 功能障碍的风险因素和结果。
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引用次数: 0
Three-Dimensional Bio-Printed Tubular Tissue Using Dermal Fibroblast Cells as a New Tissue-Engineered Vascular Graft for Venous Replacement. 利用真皮成纤维细胞的三维生物打印管状组织作为用于静脉置换的新型组织工程血管移植物
IF 3.1 3区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2024-11-01 Epub Date: 2024-05-03 DOI: 10.1097/MAT.0000000000002224
Makoto Hayasaka, Takashi Kokudo, Junichi Kaneko, Takehiro Chiyoda, Anna Nakamura, Manabu Itoh, Kazuhiro Endo, Koichi Nakayama, Kiyoshi Hasegawa

The current study was a preliminary evaluation of the feasibility and biologic features of three-dimensionally bio-printed tissue-engineered (3D bio-printed) vascular grafts comprising dermal fibroblast spheroids for venous replacement in rats and swine. The scaffold-free tubular tissue was made by the 3D bio-printer with normal human dermal fibroblasts. The tubular tissues were implanted into the infrarenal inferior vena cava of 4 male F344-rnu/rnu athymic nude rats and the short-term patency and histologic features were analyzed. A larger 3D bio-printed swine dermal fibroblast-derived prototype of tubular tissue was implanted into the right jugular vein of a swine and patency was evaluated at 4 weeks. The short-term patency rate was 100%. Immunohistochemistry analysis showed von Willebrand factor positivity on day 2, with more limited positivity observed on the luminal surface on day 5. Although the cross-sectional area of the wall differed significantly between preimplantation and days 2 and 5, suggesting swelling of the tubular tissue wall (both p < 0.01), the luminal diameter of the tubular tissues was not significantly altered during this period. The 3D bio-printed scaffold-free tubular tissues using human dermal or swine fibroblast spheroids may produce better tissue-engineered vascular grafts for venous replacement in rats or swine.

目前的研究是初步评估由真皮成纤维细胞球体组成的三维生物打印组织工程(3D 生物打印)血管移植物用于大鼠和猪静脉置换的可行性和生物特征。无支架管状组织是由三维生物打印机用正常人的真皮成纤维细胞制成的。将管状组织植入 4 只雄性 F344-rnu/rnu 无胸腺裸鼠的肾下腔静脉,分析其短期通畅性和组织学特征。将一个更大的三维生物打印猪真皮成纤维细胞衍生的管状组织原型植入一头猪的右颈静脉,并在 4 周后评估其通畅性。短期通畅率为 100%。免疫组化分析表明,第 2 天冯-威廉因子呈阳性,第 5 天在管腔表面观察到更有限的阳性。虽然管壁的横截面积在植入前与第 2 天和第 5 天之间存在显著差异,表明管壁组织发生了肿胀(均 p < 0.01),但在此期间,管腔组织的直径并没有发生显著变化。利用人体真皮或猪成纤维细胞球体进行三维生物打印的无支架小管组织可能会产生更好的组织工程血管移植物,用于大鼠或猪的静脉置换。
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引用次数: 0
Volume Displacement Pulsatile Veno-Arterial Extracorporeal Membrane Oxygenation: Preliminary Data From In Vitro Tests. 体积置换脉动性静脉-动脉体外膜氧合:体外试验的初步数据。
IF 3.1 3区 医学 Q2 ENGINEERING, BIOMEDICAL Pub Date : 2024-11-01 Epub Date: 2024-03-29 DOI: 10.1097/MAT.0000000000002207
Silver Heinsar, Clayton Semenzin, Samia M Farah, John F Fraser
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引用次数: 0
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