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BACKGROUND: Dialysis patients undergoing transcatheter aortic valve replacement (TAVR) generally have poor prognosis compared with non-dialysis patients. Furthermore, there are few reliable risk models in this clinical setting. Therefore, we aimed to establish a risk model in dialysis patients undergoing TAVR that would be informative for their prognosis and the decision-making process of TAVR. METHODS: A total 118 dialysis patients (full cohort) with severe aortic stenosis underwent TAVR in our institute between 2012 and 2022. The patients of the full cohort were randomly assigned to two groups in a 2:1 ratio to form derivation and validation cohorts. Risk factors contributing to deaths were analyzed from the preoperative variables and a risk model was established from Cox proportional hazard model. RESULTS: There were 69 deaths following TAVR derived from infectious disease (43.5 %), cardiovascular-related disease (11.6 %), cerebral stroke or hemorrhage (2.9 %), cancer (1.4 %), unknown origin (18.8 %), and others (21.7 %) during the observational period (811 ±â€¯719 days). The cumulative overall survival rates using the Kaplan-Meier method at 1 year, 3 years, and 5 years in the full cohort were 82.8 %, 41.9 %, and 24.2 %, respectively. An optimal risk model composed of five contributors: peripheral vascular disease, serum albumin, left ventricular ejection fraction < 40 %, operative age, and hemoglobin level, was established. The estimated C index for the developed models were 0.748 (95 % CI: 0.672-0.824) in derivation cohort and 0.705 (95 % CI: 0.578-0.832) in validation cohort. The prediction model showed good calibration [intraclass correlation coefficient = 0.937 (95%CI: 0.806-0.981)] between actual and predicted survival. CONCLUSIONS: The risk model was a good indicator to estimate the prognosis in dialysis patients undergoing TAVR.

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OBJECTIVE: Dysphagia is a common complication associated with cardiovascular surgery (CVS). This study sought to better understand recovery timelines, identify risk factors, and create a prognostic model for oral intake restoration. METHODS: This retrospective study included 134 patients who had CVS between April 2022 and March 2024. We assessed swallowing ability through fiberoptic endoscopic evaluation of swallowing (FEES). We randomly divided the patients' data into a training dataset and a test dataset in a ratio of 70/30 and Kaplan-Meier analyses and Cox regression were used to assess predictors of total oral intake. We also created a scoring system using the estimated regression coefficients. RESULTS: Most patients with CVS achieved total oral intake in 7-11 days after extubation. Over 168 h of intubation, the presence of penetration or aspiration, a poor FEES score (score > 6), and perioperative complications were significant risk factors for delayed total oral intake. The predicting score was calculated by adding the scores for each individual factor, including FEES score, penetration/aspiration, and preoperative complications. Scores ranged 0-8, categorizing patients into 0-2, 3-5, and 6-8 groups, clearly demonstrating that the higher the predicting score, the longer the time to total oral intake in both the training and the test dataset. CONCLUSIONS: All risk factors for unsuccessful or delayed total oral intake were intubation for more than a week, poor swallowing ability, and the presence of perioperative complications. The scoring system accurately predicts the restoration of oral intake following CVS.

Asunto(s)

Trastornos de Deglución , Complicaciones Posoperatorias , Humanos , Trastornos de Deglución/etiología , Estudios Retrospectivos , Masculino , Femenino , Anciano , Persona de Mediana Edad , Factores de Riesgo , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiología , Pronóstico , Procedimientos Quirúrgicos Cardiovasculares/efectos adversos , Deglución/fisiología , Factores de Tiempo , Recuperación de la Función

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BACKGROUND: Variations in the aortomitral positional anatomy, including aortic root rotation appear to be related to variations in the location of the conduction system, including the bundle of His. However, little is known about their clinical significance. METHODS AND RESULTS: This study included 147 patients with normal ECGs who underwent mitral valve surgery. The aortomitral anatomy was classified using preoperative 3-dimensional transesophageal echocardiography, and postoperative conduction disorders, including atrioventricular block and bundle branch block, were analyzed. Variations classified as aortomitral appearance were designated as having a center appearance (85.7%, n=126/147) or lateral appearance (14.3%, n=21/147) on the basis of whether the aortic root was located at the center or was shifted to the left fibrous trigone side. Subsequently, those with a center appearance, aortic root rotation was classified as having a center rotation (83.3% [n=105/126]), in which the commissure of the left and noncoronary aortic leaflet was located at the center, lateral rotation (14.3% [n=18/126]), rotated to the left trigone side, or medial rotation (2.4% [n=3/126]), rotated to the right. The incidence of 3-month persistent new-onset conduction disorder was higher in the lateral appearance than the center appearance group (21.1% versus 5.0%; P=0.031) and higher in the lateral rotation than in the center or medial rotation groups (29.4% versus 1.0% versus 0.0%, respectively; P<0.001). CONCLUSIONS: Aortomitral variations can be classified using 3-dimensional transesophageal echocardiography. Lateral appearance and lateral rotation are risk factors for conduction disorders in mitral valve surgery.

Asunto(s)

Bloqueo Atrioventricular , Ecocardiografía Tridimensional , Ecocardiografía Transesofágica , Válvula Mitral , Humanos , Masculino , Femenino , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Válvula Mitral/fisiopatología , Persona de Mediana Edad , Bloqueo Atrioventricular/etiología , Bloqueo Atrioventricular/fisiopatología , Bloqueo Atrioventricular/diagnóstico , Anciano , Estudios Retrospectivos , Electrocardiografía , Bloqueo de Rama/fisiopatología , Bloqueo de Rama/etiología , Factores de Riesgo , Aorta/diagnóstico por imagen , Aorta/cirugía , Aorta/fisiopatología , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Adulto , Resultado del Tratamiento , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/diagnóstico por imagen

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We examined the number of patients abandoning cardiac replacement therapy due to the inability to secure a designated caregiver. At Osaka University Hospital Heart Center, when we receive a consultation for a patient with severe heart failure from another hospital, a heart failure team makes a visit to the referring hospital as soon as possible. We retrospectively analyzed this hospital-visit database. We received 199 severe heart failure consultations from 2016-2023. Issues identified during hospital visits included age ≥ 65 years (8%), inability to confirm the patient's intention (8.5%), and explicit refusal of therapy (2.5%). Medical problems included multiple organ failure (18.1%), obesity (13.1%), diabetes (9.5%), malignancy (5.5%), chronic dialysis (1.0%), and other systemic diseases (12.6%). Adherence problems included poor medication compliance (3.5%), history of heavy drinking (2.5%), and smoking (2.0%). Social problems included inadequate family support in 16.1% of patients. Of the 199 patients, 95 (48.0%) proceeded to a heart transplant and LVAD indication review meeting at Osaka University Hospital. The remaining 104 patients (52.0%) did not proceed to the meeting. Reasons included improvement of heart failure with conservative treatment in 37 cases (35.6%), death before discussion in 21 cases (20.2%), medical contraindications in 18 cases (18.3%), lack of caregivers in 18 cases (18.3%; 9.5% of 199 cases), and patient refusal in 5 cases (4.8%). Approximately 10% of patients consulted at Osaka University Hospital Heart Center for severe heart failure abandoned cardiac replacement therapy due to the lack of caregivers.

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A 53-year-old woman with the dilated phase of hypertrophic cardiomyopathy underwent orthotopic heart transplantation. The donor heart was evaluated as normal preoperatively without mitral regurgitation or the left atrium dilation, transplanted using the modified bicaval technique. Although the heart beat satisfactorily after aortic declamping, massive mitral regurgitation was observed without any prolapse or annular dilation. Because of the difficulty in weaning from cardiopulmonary bypass, a second aortic cross-clamp was applied, and we detached the inferior vena cava and the right side of the left atrial anastomosis to approach the mitral valve, obtaining a satisfactory exposure. No abnormalities were observed in the mitral valve leaflets, annulus or subvalvular apparatus. Subsequent in vivo mitral annuloplasty using prosthetic full ring successfully controlled the regurgitation, and the patient was easily weaned from cardiopulmonary bypass. She discharged to home with good mitral valve and cardiac functions. And the patient has been doing well without any recurrence of MR or heart failure for over a year after surgery.

Asunto(s)

Trasplante de Corazón , Insuficiencia de la Válvula Mitral , Válvula Mitral , Humanos , Trasplante de Corazón/métodos , Persona de Mediana Edad , Femenino , Insuficiencia de la Válvula Mitral/cirugía , Válvula Mitral/cirugía , Donantes de Tejidos , Anuloplastia de la Válvula Mitral/métodos , Cardiomiopatía Hipertrófica/cirugía

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The world's first clinical cardiac xenotransplantation, using a genetically engineered pig heart with 10 gene modifications, prolonged the life of a 57-year-old man with no other life-saving options, by 60 days. It is foreseeable that xenotransplantation will be introduced in clinical practice in the United States. However, little clinical or regulatory progress has been made in the field of xenotransplantation in Japan in recent years. Japan seems to be heading toward a "device lag", and the over-importation of medical devices and technology in the medical field is becoming problematic. In this review, we discuss the concept of pig-heart xenotransplantation, including the pathobiological aspects related to immune rejection, coagulation dysregulation, and detrimental heart overgrowth, as well as genetic modification strategies in pigs to prevent or minimize these problems. Moreover, we summarize the necessity for and current status of xenotransplantation worldwide, and future prospects in Japan, with the aim of initiating xenotransplantation in Japan using genetically modified pigs without a global delay. It is imperative that this study prompts the initiation of preclinical xenotransplantation research using non-human primates and leads to clinical studies.

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Animales Modificados Genéticamente , Trasplante de Corazón , Trasplante Heterólogo , Animales , Porcinos , Japón , Humanos , Rechazo de Injerto , Masculino , Persona de Mediana Edad , Ingeniería Genética , Coagulación Sanguínea , Corazón

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BACKGROUND: Based on the results of a clinical trial in Japan, transcatheter aortic valve replacement (TAVR) for hemodialysis (HD) patients gained approval; however, mid-term TAVR outcomes and transcatheter aortic valve (TAV) durability in HD patients remain unexplored.Methods and Results: We analyzed background, procedural, in-hospital outcome, and follow-up data for 101 HD patients and 494 non-HD patients who underwent TAVR using balloon-expandable valves (SAPIEN XT or SAPIEN 3) retrieved from Osaka University Hospital TAVR database. Periprocedural mortality and TAVR-related complications were comparable between HD and non-HD patients. However, Kaplan-Meier analysis revealed that HD patients had significantly lower survival rates (log-rank test, P<0.001). In addition, HD patients had significantly higher rates of severe structural valve deterioration (SVD) than non-HD patients (Gray test, P=0.038). CONCLUSIONS: TAVR in HD patients had comparable periprocedural mortality but inferior mid-term survival and TAV durability than in non-HD patients. Indications for TAVR in younger HD patients should be carefully determined, considering the possibility of a TAV-in-TAV procedure when early SVD occurs.

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Advance care planning (ACP) is essential in managing serious and chronic illnesses to ensure that patients receive care aligned with their personal values, goals, and preferences. This review focuses on integrating ACP in the treatment of patients receiving implantable left ventricular assist devices (VADs). The heart failure palliative care team developed a unique advance directive form and pamphlet to facilitate ACP discussions, emphasizing not only medical treatment preferences but also patients' values and life goals.The study highlights the distinction between bridge to transplantation (BTT) and destination therapy (DT) in VAD patients, with different goals and considerations for ACP. The use of decision aids developed especially for DT candidates as a communication tool helps in sharing patients' wishes and facilitates shared decision-making, particularly in the complex decisions surrounding DT therapy.Challenges in implementing ACP, such as time constraints due to urgent medical conditions, difficulties in patient communication, and the recent COVID-19 pandemic, are addressed. The need for a comprehensive healthcare system capable of supporting patients' ACP wishes, especially in the community setting, is also pointed out.Future directions include not only developing materials to ease ACP discussions and ensuring that ACP content is shared among healthcare providers to foster collaborative and detailed planning, but also a call for widespread adoption of ACP in Japan.This is a translation of a paper written in Japanese Journal of Artificial Organs (Vol. 52, No. 1, pp. 89-92) with additions and corrections.

Asunto(s)

Planificación Anticipada de Atención , Corazón Auxiliar , Humanos , COVID-19/epidemiología , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/cirugía , Japón

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BACKGROUND: For patients with nonischemic dilated cardiomyopathy (NIDCM), the indications for and results of mitral surgery remain controversial. We reviewed a strategy of mitral repair and replacement for clinically relevant secondary mitral regurgitation (MR) in patients with NIDCM. METHODS: We retrospectively reviewed 65 patients with advanced NIDCM (LVEF < 40%) who underwent mitral surgery. Of them, 47 (72%) underwent mitral annuloplasty and 18 (28%) replacement for secondary MR. The primary endpoint was postoperative reduction in indexed LV end-systolic volume (LVESVI). RESULTS: At baseline, there was no intergroup difference in LVESVI (123 ± 47 vs. 147 ± 37 ml/m2, P = 0.055), LVEF (27 ± 8% vs. 25 ± 6%, P = 0.41), incidence of severe MR (57% (27/47) vs. 72% (13/18), P = 0.40), or EuroSCORE II score (6.2% vs. 7.6%, P = 0.90). At 6 months, the annuloplasty group reduced LVESVI to a greater degree than the replacement group (P < 0.001), yielding significantly smaller postoperative LVESVI (96 ± 59 vs. 154 ± 61 ml/m2, P < 0.001) and better LVEF (P < 0.001). The rates of moderate/severe recurrent MR were 17% (8/47) and 0%, respectively. Multivariable analysis demonstrated that mitral annuloplasty (OR 6.10, 95% CI 1.14-32.8, P = 0.035) was significantly associated with postoperative LV reverse remodeling. Cumulative survival was not different between the groups (P = 0.26). CONCLUSIONS: In patients with NIDCM, mitral annuloplasty reduced LV volume to a greater degree than did mitral replacement. These findings may assist with surgical options for secondary MR associated with NIDCM.

Asunto(s)

Cardiomiopatía Dilatada , Anuloplastia de la Válvula Mitral , Insuficiencia de la Válvula Mitral , Humanos , Cardiomiopatía Dilatada/cirugía , Insuficiencia de la Válvula Mitral/cirugía , Periodo Posoperatorio , Estudios Retrospectivos

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PURPOSE: Culture of extracted drains or epicardial pacing wires is an easy and noninvasive method for detecting mediastinitis after open-heart surgery, although studies on its sensitivity and specificity are limited. We, therefore, investigated the usefulness of this approach for diagnosing mediastinitis. METHODS: We retrospectively studied the culture results of drains and epicardial pacing wires extracted from 3308 patients. Prediction models of mediastinitis with and without culture results added to clinical risk factors identified by a logistic regression analysis were compared. RESULTS: The incidence of mediastinitis requiring surgery was 1.89% (n = 64). Staphylococcus was the causative bacterium in 64.0% of cases. The sensitivity, specificity, and positive and negative predictive values of positive culture results were 50.8%, 91.8%, 10.7%, and 99.0%, respectively. Methicillin-resistant Staphylococcus aureus had the highest positive predictive value (61.5%). A multivariate analysis identified preoperative hemodialysis (OR 5.40 [2.54-11.5], p < 0.01), long operative duration (p < 0.01), postoperative hemodialysis (OR 2.25 [1.01-4.98], p < 0.05), and positive culture result (OR 10.2 [5.88-17.7], p < 0.01) as independent risk factors. The addition of culture results to pre- and postoperative hemodialysis and a lengthy operative time improved the prediction of mediastinitis. CONCLUSIONS: A culture survey using extracted drains and epicardial pacing wires may provide useful information for diagnosing mediastinitis.

Asunto(s)

Procedimientos Quirúrgicos Cardíacos , Mediastinitis , Staphylococcus aureus Resistente a Meticilina , Humanos , Estudios Retrospectivos , Mediastinitis/diagnóstico , Mediastinitis/etiología , Mediastinitis/terapia , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Staphylococcus

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Patients with diffuse frontal gliomas often present with post-operative apathy after tumour removal. However, the association between apathy and tumour removal of gliomas from the frontal lobe remains unknown. This study aimed to investigate the factors influencing post-operative apathy after tumour removal in patients with diffuse frontal gliomas. We compared the demographics and clinical characteristics of patients with and without post-operative apathy in a cohort of 54 patients who underwent awake brain mapping for frontal gliomas. The frequency of clinical parameters such as left-sided involvement, high-grade tumour types (WHO grades III, IV), main tumour location in the anterior cingulate gyrus (ACC) and/or dorsolateral prefrontal cortex (DLPFC) and orbitofrontal cortex (OFC) was significantly greater in the apathetic group compared to the non-apathetic group. The apathetic group scored significantly lower on neuropsychological assessments such as the Letter Fluency Test among the Word Fluency Tests than the non-pathetic group (p = .000). Moreover, the scores of Parts 3, and 3-1 of the Stroop test were significantly lower in the apathetic group than those in the non-apathetic group (p = .023, .027, respectively). Multivariate model analysis revealed that the appearance of post-operative apathy was significantly related to side of the of lesion [left vs. right, hazard ratio (HR) = 8.00, 95% confidence interval (CI) = 1.36-46.96, p = .021], location of the main tumour in the frontal lobe (ACC/DLPFC/OFC vs. others, HR = 7.99, 95% CI = 2.16-29.59, p = .002), and the Letter Fluency Test (HR = .37, 95% CI = .15-.90, p = .028). Post-operative apathy is significantly associated with ACC and/or DLPFC and OFC in the left hemisphere of diffuse frontal gliomas. Apathy in frontal gliomas is correlated with a decline in the Letter Fluency Test scores. Therefore, this instrument is a potential predictor of post-operative apathy in patients with diffuse frontal gliomas undergoing awake brain mapping.

Asunto(s)

Apatía , Glioma , Humanos , Vigilia , Corteza Cerebral , Lóbulo Frontal/cirugía , Mapeo Encefálico , Glioma/cirugía

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Objective: Whereas transcatheter aortic valve replacement is widely implemented, annular rupture is a devastating complication and could be highly mortal. However, owing to its rare incidence, the optimal treatment algorithm has not been established. Thus, we evaluated the feasibility and effectiveness of a 3-step algorithm to treat annulus rupture. Methods: From 2009 to 2022, 8 patients of 1083 transcatheter aortic valve implantation (0.8%) developed annulus rupture and were treated with the three-step algorithm. The algorithm was composed of a first step (pericardial drainage and protamine neutralization with blood pressure control), second step (manual hemostatic compression via full/partial sternotomy), and a third step (conservative treatment or radical surgical correction). Results: The median age at the procedure was 85 (78-88) years and 7 female patients were included in this study. Two (25%) patients had end-stage renal failure under hemodialysis, and median Society of Thoracic Surgeons score was 8.9% (2.1%-23.2%). The implanted transcatheter heart valves (THVs) were 7 balloon-expandable THVs and 1 self-expandable THV with balloon postdilatation. Under this strategy, 8 (100%) patients underwent pericardial drainage as first step and 5 patients achieved hemostasis. Of these, patient 1 demonstrated bleeding from left sinus of Valsalva and required a Bentall procedure. Although the etiology of this phenomenon was not investigated by contrast-enhanced computed tomography, it might be derived from pseudoaneurysm rupture or delayed annular rupture. In 2 patients, the second step treatment was needed for hemostasis. Third-step treatment was conducted in 1 patient. Postoperatively, 6 patients could be discharged without critical complications whereas 2 patients died during the hospitalization. There were no other complications during the followed-up (584 [7-1614]) days. Conclusions: In accordance with the three-step algorithm, 6 patients, including those with high-risk or inoperative status, survived.

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Introduction: With the expected increase in patients with heart failure and ischemic 15 cardiomyopathy, the development of myocardial regenerative medicine using cell transplantation as a novel treatment method is progressing. This first-in-human clinical trial aimed to confirm the safety of cardiomyocyte patch transplantation derived from allogeneic induced pluripotent stem (iPS) cells based on the results of several preclinical studies. Study design: The inclusion criteria were left ventricular ejection fraction of 35% or less; heart failure symptoms of New York Heart Association class III or higher despite existing therapies such as revascularization; and a 1-year observation period that included a 3-month immunosuppressive drug administration period after transplantation of iPS cell-derived cardiomyocyte patches to evaluate adverse events, cardiac function, myocardial blood flow, heart failure symptoms, and immune response. Results: In the first three cases of this trial, no transplanted cell-related adverse events were observed during the 1-year observation period, and improvement in heart failure symptoms was observed. In addition, improvements in left ventricular contractility and myocardial blood flow were observed in two of the three patients. Regarding immune response, an increase in transplant cell-specific antibody titer was observed in all three patients after immunosuppressive drug administration. In one patient with poor improvement in cardiac function and myocardial blood flow, an increase in antibody titer against HLA-DQ was observed even before cell transplantation. Conclusions: Our case findings demonstrate that the transplantation of iPS cell-derived cardiomyocyte patches for ischemic cardiomyopathy can be safely performed; however, further investigation of the therapeutic effect and its relationship with an immune response is needed by accumulating the number of patients through continued clinical trials.

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Objective: In patients with ischemic cardiomyopathy, coronary artery bypass grafting ensures better survival than medical therapy. However, the long-term clinical impact of complete revascularization remains unclear. This observational study aimed to evaluate the effects of complete revascularization on long-term survival and left ventricular functional recovery in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting. Methods: We retrospectively reviewed outcomes of 498 patients with ischemic cardiomyopathy who underwent complete (n = 386) or incomplete (n = 112) myocardial revascularization between 1993 and 2015. The baseline characteristics were adjusted using inverse probability of treatment weighting to reduce the impact of treatment bias and potential confounding. The mean follow-up duration was 77.2 ± 42.8 months in survivors. Results: The overall 5-year survival rate (complete revascularization, 72.5% vs incomplete revascularization, 57.9%, P = .03) and freedom from all-cause death and/or readmission due to heart failure (54.5% vs 40.1%, P = .007) were significantly greater in patients with complete revascularization than those with incomplete revascularization. After adjustments using inverse probability of treatment weighting, the complete revascularization group demonstrated a lower risk of all-cause death (hazard ratio, 0.61; 95% confidence interval, 0.43-0.86; P = .005) and composite adverse events (hazard ratio, 0.59; 95% confidence interval, 0.44-0.79; P < .001) and a greater improvement in the left ventricular ejection fraction 1-year postoperatively (absolute change: 11.0 ± 11.9% vs 8.3 ± 11.4%, interaction effect P = .05) than the incomplete revascularization group. Conclusions: In patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting, complete revascularization was associated with better long-term outcomes and greater left ventricular functional recovery and should be encouraged whenever possible.

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Transplantation of human allogeneic induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) is a new, promising treatment for severe heart failure. However, immunorejection is a significant concern in allogeneic hiPSC-CM transplantation, requiring the administration of several immunosuppressive agents. An appropriate protocol for the administration of immunosuppressants may substantially affect the efficacy of hiPSC-CM transplantation in case of heart failure owing to allogeneic transplantation. In this study, we investigated the effect of immunosuppressant administration duration on the efficacy and safety of allogenic hiPSC-CM patch transplantation. We used a rat model of myocardial infarction to evaluate cardiac function using echocardiography six months after the transplantation of hiPSC-CM patches with immunosuppressant administration for either two or four months and compared them to control rats (sham operation, no immunosuppressant administration). Histological analysis performed at 6 months after hiPSC-CM patch transplantation revealed significant improvement in cardiac function in immunosuppressant-treated rats compared with those in the control group. Moreover, fibrosis and cardiomyocyte size was significantly reduced and the number of structurally mature blood vessels was significantly increased in the immunosuppressant-treated rats compared to control rats. However, there were no significant differences between the two immunosuppressant-treated groups. Our results show that prolonged administration of immunosuppressive agents did not enhance the effectiveness of hiPSC-CM patch transplantation, and therefore, highlight the importance of an appropriate immunological regimen for the clinical application of such transplantation.

Asunto(s)

Insuficiencia Cardíaca , Células Madre Pluripotentes Inducidas , Infarto del Miocardio , Humanos , Animales , Ratas , Preparaciones Farmacéuticas , Miocitos Cardíacos , Inmunosupresores/farmacología , Infarto del Miocardio/terapia

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BACKGROUND: There have been few reports on the mid- to long-term safety and efficacy validation of the INSPIRIS RESILIA aortic bioprosthesis (Edwards Lifesciences LLC, Irvine, CA, USA) in Japan. Herein, we report the mid-term results of surgical aortic valve replacement (AVR) for aortic stenosis using INSPIRIS and evaluate the hemodynamics compared to the CEP Magna series from the multicenter AVR registry (the ACTIVIST registry). METHODS: Of the 1967 patients who underwent surgical or transcatheter AVR from the ACTIVIST registry, 66 patients who underwent isolated surgical AVR with INSPIRIS by December 2020 were included in this study, and the early and mid-term results were evaluated. Hemodynamics were evaluated by comparing 272 patients undergoing isolated surgical AVR with the Magna group using propensity score matching. RESULTS: The mean age was 74.0 ±â€¯7.8 years, and 48.5 % were women. In-hospital mortality was 1.5 %, and the survival rates at 1- and 2-years were 95.2 % and 95.2 %, respectively. After propensity score matching, echocardiographic findings at discharge demonstrated that peak velocity and mean pressure gradient in the INSPIRIS group were comparable, while the effective orifice area in the INSPIRIS group was significantly larger than those in the Magna group (p = 0.048). A patient-prosthesis mismatch at discharge was significantly lower in the INSPIRIS group (11.8 %) than in the Magna group (36.4 %) (p = 0.004). CONCLUSIONS: Surgical AVR with INSPIRIS was performed safely and the mid-term results were satisfactory. The hemodynamics of INSPIRIS were comparable to those of Magna.

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Estenosis de la Válvula Aórtica , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Humanos , Femenino , Anciano , Anciano de 80 o más Años , Masculino , Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Resultado del Tratamiento , Estenosis de la Válvula Aórtica/cirugía , Sistema de Registros , Hemodinámica , Diseño de Prótesis , Estudios Retrospectivos

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A 48-year-old male patient developed acute myeloid leukemia (AML) with t(3;3)(q21.3;q26.2) chromosomal mutation 8 months after orthotopic heart transplantation from a human leukocyte antigen-unmatched brain-dead donor for cardiac sarcoidosis. He had sequelae of stroke and chronic renal failure at the time of AML diagnosis. He received 3 cycles of azacitidine and venetoclax induction therapy and achieved complete hematological remission with incomplete count recovery without causing severe complications, including infection. He sequentially underwent allogeneic peripheral blood stem cell transplantation from a HLA-8/8 matched, ABO-blood matched, unrelated female donor and successfully achieved donor cell engraftment. His transplanted heart was viable, and the coronary vessels were not damaged even after allogeneic peripheral blood stem cell transplantation. Although AML relapsed afterward, azacytidine/venetoclax was a tolerable bridging therapy even for early-onset AML after heart transplantation.

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Trasplante de Corazón , Trasplante de Células Madre Hematopoyéticas , Leucemia Mieloide Aguda , Masculino , Humanos , Femenino , Persona de Mediana Edad , Azacitidina/uso terapéutico , Trasplante Homólogo , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Leucemia Mieloide Aguda/terapia , Trasplante de Corazón/efectos adversos

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Objectives: The study objectives were to determine the incidence, predictors, and clinical impact of ventricular arrhythmias after coronary artery bypass grafting and to evaluate the impact of implantable cardioverter defibrillators on the survival of patients with ventricular arrhythmias. Methods: We enrolled 498 patients with a left ventricular ejection fraction of 40% or less who underwent coronary artery bypass grafting between 1993 and 2015. Clinical follow-up was completed in 94.0% of patients, with a median follow-up of 58.4 months. Results: Overall, 212 patients (43%) died, mainly of heart failure (n = 54, 10.8%) or sudden cardiac death (n = 40, 8.0%). The sudden cardiac death rate was highest during the first 6 months, with a monthly rate of 0.37%. Overall, 99 patients (20%) developed postoperative ventricular arrhythmias, and implantable cardioverter defibrillator was implanted in 55 patients. Previous ventricular arrhythmias (hazard ratio, 3.22; 95% confidence interval, 1.98-5.24; P < .001), left ventricular end-systolic dimension (hazard ratio, 1.07; 95% confidence interval, 1.04-1.10; P < .001), and myocardial infarction in the left anterior descending artery territory (hazard ratio, 1.73; 95% confidence interval, 1.10-2.73; P = .02) were independent predictors of postoperative ventricular arrhythmias. Notably, the 5-year survival of patients with ventricular arrhythmias who received an implantable cardioverter defibrillator was significantly higher than that of patients with ventricular arrhythmias who did not receive it (76.1% vs 22.7%, P < .001) and was comparable to that of patients without ventricular arrhythmias (76.1% vs 73.6%, P = .98). Conclusions: Sudden cardiac death affects a significant proportion of patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting, most frequently within 6 months postoperatively. To prevent sudden cardiac death, earlier implantable cardioverter defibrillator implantation should be indicated for high-risk patients with scars in the left anterior descending artery territory and excessive left ventricular remodeling.

RESUMEN

Fulminant myocarditis (FM) requiring temporary mechanical circulatory support (t-MCS) has a high mortality rate. Peripheral veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and intra-aortic balloon pump (IABP) are sometimes insufficient to induce cardiac recovery. For patients with FM refractory to VA-ECMO with IABP, we have applied a biventricular assist device (BIVAD) or Impella to unload the left ventricle and to fully support the systemic circulation. In the last 10 years, 37 refractory FM patients histologically diagnosed with myocarditis and who did not recover with VA-ECMO were treated with BIVAD (n = 19) or Impella (n = 18). No significant difference was found between the Impella and BIVAD groups in preoperative findings other than serum creatinine level. Seventeen of 18 patients in the Impella group were successfully weaned from t-MCS in 9 (6-12) days. Conversely, the temporary BIVAD was removed in 21 (11-38) days in 10 of 19 patients. Six patients died while on temporary BIVAD because of multiple organ failure and cerebral bleeding, and three patients required conversion to implantable VAD. Compared with BIVAD, left ventricular unloading with Impella could be less invasive and could promote cardiac recovery in refractory FM patients. The Impella has the potential to provide effective temporary MCS for FM patients.

Asunto(s)

Oxigenación por Membrana Extracorpórea , Corazón Auxiliar , Miocarditis , Humanos , Ventrículos Cardíacos/cirugía , Miocarditis/cirugía , Miocarditis/diagnóstico , Contrapulsador Intraaórtico , Choque Cardiogénico/etiología , Choque Cardiogénico/cirugía

RESUMEN

Background: YS-1402, which is a polymerized form of the synthetic prostacyclin agonist ONO-1301, has been proven in several preclinical studies to induce therapeutic effects for patients with ischemic cardiomyopathy (ICM). In this human study, we assessed the safety, tolerability, and efficacy of YS-1402, combined with coronary artery bypass grafting (CABG), for ICM. Methods: Twenty-four patients with ICM whose left ventricular ejection fraction was <40% with an indication for CABG were double-blindly assigned to four groups: placebo, 10-mg YS-1402, 30-mg YS-1402, and 100-mg YS-1402. YS-1402 or placebo medications were administered on the surface of the left ventricle at the time of the CABG. Pre- and postoperative cardiac function and myocardial blood flow were assessed for 6 months postoperatively, along with a safety assessment. Results: No severe adverse events were related to YS-1402. The maximum blood concentration of ONO-1301 was less than that of the no observable adverse effect level. Significantly increased myocardial blood flow (MBF) and cardiac function were observed in the YS-1402 group 26 weeks postoperatively, although no improvement in MBF occurred in the placebo group. Conclusion: This Phase I/IIa parallel group-controlled, dose-escalation study of YS-1402 combined with CABG for ICM demonstrated the safety, tolerability, and potential efficacy of YS-1402.