Preoperative Computed Tomography of the Right Gastroepiploic Artery for Coronary Artery Bypass Grafting.

BACKGROUND: Grafting the right gastroepiploic artery (GEA) to the right coronary artery (RCA) is effective, but preoperative evaluation of arterial conduit availability has not been established. By comparing the midterm graft results, we aimed to assess the efficacy of preoperative evaluation of the GEA using computed tomography (CT).Methods and Results: We retrospectively examined patients who underwent isolated coronary artery bypass grafting surgery between April 2010 and December 2020, and those whose GEA was grafted to the RCA were selected: 55 patients were included in the study analysis. Postoperative evaluations were performed during the early phase, 1 year postoperatively, and at follow-up evaluations. The outer diameter of the proximal GEA was compared with the midterm graft patency grade on CT and patients were classified as Functional (Grade A) or Dysfunctional (Grades O or B). The proximal GEA outer diameters were significantly different between the Functional and Dysfunctional groups (P<0.001). Furthermore, multivariate Cox regression analysis revealed that this diameter was an independent predictor of graft functionality (P<0.001). Patients with outer proximal diameters larger than the cutoff value had superior graft results at 3 years postoperatively. The rate of freedom from a dysfunctional graft at 3 years postoperatively was 95.5% and 45.5% for the Larger and Smaller diameter subgroups, respectively (P<0.001). CONCLUSIONS: Preoperative evaluation of the outer diameter of the proximal GEA, excluding calcified GEA, using CT is a minimally invasive and useful method, and may improve midterm results of in-situ GEA grafting, even in severe stenotic lesions.

Novel Scoring System to Risk Stratify Patients Receiving Durable Left Ventricular Assist Device From J-MACS Registry Data.

BACKGROUND: Recently, destination therapy (DT) was approved in Japan, and patients ineligible for heart transplantation may now receive durable left ventricular assist devices (LVADs). Several conventional risk scores are available, but a risk score that is best to select optimal candidates for DT in the Japanese population remains unestablished.Methods and Results: A total of 1,287 patients who underwent durable LVAD implantation and were listed for the Japanese registry for Mechanically Assisted Circulatory Support (J-MACS) were eligible for inclusion. Finally, 494 patients were assigned to the derivation cohort and 487 patients were assigned to the validation cohort. According to the time-to-event analyses, J-MACS risk scores were newly constructed to predict 3-year mortality rate, consisting of age, history of cardiac surgery, serum creatinine level, and central venous pressure to pulmonary artery wedge pressure ratio >0.71. The J-MACS risk score had the highest predictability of 3-year death compared with other conventional scores in the validation cohort, including HeartMate II risk score and HeartMate 3 risk score. CONCLUSIONS: We constructed the J-MACS risk score to estimate 3-year mortality rate after durable LVAD implantation using large-scale multicenter Japanese data. The clinical utility of this scoring to guide the indication of DT should be validated in the next study.

Innovative experimental animal models for real-time comparison of antithrombogenicity between two oxygenators using dual extracorporeal circulation circuits and indocyanine green fluorescence imaging.

BACKGROUND: Antithrombogenicity of extracorporeal membrane oxygenation (ECMO) devices, particularly oxygenators, is a current problem, with numerous studies and developments underway. However, there has been limited progress in developing methods to accurately compare the antithrombogenicity of oxygenators. Animal experiments are commonly conducted to evaluate the antithrombogenicity of devices; however, it is challenging to maintain a steady experimental environment. We propose an innovative experimental animal model to evaluate different devices in a constant experimental environment in real-time. METHODS: This model uses two venous-arterial ECMO circuits attached to one animal (one by jugular vein and carotid artery, one by femoral vein and artery) and real-time assessment of thrombus formation in the oxygenator by indocyanine green (ICG) fluorescence imaging. Comparison studies were conducted using three pigs: one to compare different oxygenators (MERA vs. CAPIOX) (Case 1), and two to compare antithrombotic properties of the oxygenator (QUADROX) when used under different hydrodynamic conditions (continuous flow vs. pulsatile flow) (Cases 2 and 3). RESULTS: Thrombi, visualized using ICG imaging, appeared as black dots on a white background in each oxygenator. In Case 1, differences in the site of thrombus formation and rate of thrombus growth were observed in real-time in two oxygenators. In Case 2 and 3, the thrombus region was smaller in pulsatile than in continuous conditions. CONCLUSIONS: We devised an innovative experimental animal model for comparison of antithrombogenicity in ECMO circuits. This model enabled simultaneous evaluation of two different ECMO circuits under the same biological conditions and reduced the number of sacrificed experimental animals.

The Use of Intraoperative Transit Time Flow Measurement for Coronary Artery Bypass Surgery: Systematic Review of the Evidence and Expert Opinion Statements.

Transit time flow measurement (TTFM) allows quality control in coronary artery bypass grafting but remains largely underused, probably because of limited information and the lack of standardization. We performed a systematic review of the evidence on TTFM and other methods for quality control in coronary artery bypass grafting following PRISMA standards and elaborated expert recommendations by using a structured process. A panel of 19 experts took part in the consensus process using a 3-step modified Delphi method that consisted of 2 rounds of electronic voting and a final face-to-face virtual meeting. Eighty percent agreement was required for acceptance of the statements. A 2-level scale (strong, moderate) was used to grade the statements based on the perceived likelihood of a clinical benefit. The existing evidence supports an association between TTFM readings and graft patency and postoperative clinical outcomes, although there is high methodological heterogeneity among the published series. The evidence is more robust for arterial, rather than venous, grafts and for grafts to the left anterior descending artery. Although TTFM use increases the duration and the cost of surgery, there are no data to quantify this effect. Based on the systematic review, 10 expert statements for TTFM use in clinical practice were formulated. Six were approved at the first round of voting, 3 at the second round, and 1 at the virtual meeting. In conclusion, although TTFM use may increase the costs and duration of the procedure and requires a learning curve, its cost/benefit ratio seems largely favorable, in view of the potential clinical consequences of graft dysfunction. These consensus statements will help to standardize the use of TTFM in clinical practice and provide guidance in clinical decision-making.

Surgical strategy for inflammatory thoracic aortic aneurysms in the endovascular surgery era.

OBJECTIVE: Inflammatory thoracic aortic aneurysms (TAAs) are very rare aortic conditions. Resection and replacement of the inflammatory aorta is the first-line treatment, and thoracic endovascular aortic repair (TEVAR) has recently been reported as a less invasive alternative even for this aortic cohort. In the present study, we reviewed our experience with inflammatory TAAs and assessed the preoperative management, surgical procedures, and outcomes. METHODS: From 2006 to 2019, 21 surgeries were performed for inflammatory TAAs in 17 of 2583 patients (0.7%) who had undergone cardiovascular surgery at our institution. The etiologies were Takayasu's arteritis in 13 patients, giant cell arteritis in 2, antineutrophil cytoplasmic antibody-associated vasculitis in 1, and unknown in 1. The mean follow-up period was 66.2 ± 50.2 months (range, 19-186 months). RESULTS: Three patients had undergone multiple surgeries. The aorta was replaced in 14 patients (ascending aorta in 9, aortic arch in 4, and thoracoabdominal aorta in 1). Three isolated TEVARs were performed in two patients and single-stage hybrid aortic repair (ascending aorta and partial arch replacement combined with zone 0 TEVAR) in four patients for extended arch and descending thoracic aortic aneurysms. Stent grafts were deployed on the native aorta in five of the seven TEVARs. The perioperative inflammation was well-controlled with prednisolone (mean dose, 7.4 ± 9.4 mg) in all patients except for one who had required two surgeries under inflammation-uncontrolled situations. No aorta-related complications, including anastomotic aneurysms and TEVAR-related aortic dissection, developed during the follow-up period, and the 5-year freedom from all-cause death was 92.9%. CONCLUSIONS: The mid-term outcomes of surgery for inflammatory TAAs were acceptable. Although replacement remains the standard procedure for inflammatory TAAs, TEVAR is a less invasive acceptable alternative when the inflammation is properly managed.

One-Stage Hybrid Total Aortic Arch and Descending Thoracic Aortic Repair is a Safe and Secure Procedure With Less Postoperative Complications for Extended Aortic Arch Aneurysms.

PURPOSE: Hybrid aortic arch repair (HAR) has been implemented for extended aortic arch and descending thoracic aortic disease since 2012 in our institution. This study aimed to estimate the early and mid-term efficacy and safety of HAR. MATERIALS AND METHODS: From 2007 to 2019, 56 patients underwent HAR for extended aortic arch disease, and 75 patients underwent total arch replacement (TAR) for arch-limited disease. HAR comprises 3 procedures: replacement of the aorta, reconstruction of all arch vessels, and thoracic endovascular aortic repair (TEVAR) from zone 0 to the descending aorta after cardiopulmonary bypass is off in 1 stage. The type II-1 HAR procedure, in which the ascending aorta and aortic arch distal to the brachiocephalic artery are replaced, was the most frequently selected procedure (40/56 patients). The outcomes of the type II-1 HAR procedure were compared with those of TAR using the Cox regression analysis. RESULTS: The median follow-up period was 36 months. In HAR, the operative mortality, in-hospital mortality, and postoperative permanent neurological deficits were not observed. The paraplegia rate was 1.8%. TEVAR-related complications occurred in 3 patients. Among the patients with non-ruptured atherosclerotic aortic arch aneurysm (31 type II-1 HAR patients and 36 TAR patients, the postoperative respiratory support time in those who underwent type II-1 HAR was quicker than in those who underwent TAR (p<0.01). The rate of 6 year freedom from all-cause death in type II-1 HAR (83.1%) was numerically higher than that in TAR (74.7%), and the rate of 6 year freedom from surgery-related complications in type II-1 HAR (90.3%) was numerically lower than that in TAR (96.9%) due to the occurrence of TEVAR-related complications, and the rate of 6 year freedom from reintervention to the descending thoracic aorta in type II-1 HAR (100%) seemed to be better than that in TAR (83.7%). However, Cox regression analysis did not reveal any statistical difference between the 2 procedures. CONCLUSIONS: HAR, especially the type II-1 procedure, can treat extended aortic arch disease with acceptable survival outcomes. The development of TEVAR technology will further improve the outcomes of HAR in the future.

Effect of Diabetes Mellitus on Outcomes in Patients With Left Ventricular Assist Device　- Analysis of Data From a Japanese National Database.

BACKGROUND: The objective of this study is to investigate the effect of preoperative diabetes on all-cause mortality and major postoperative complications among patients with continuous-flow left ventricular assist device (LVAD) by using data from a national database.Methods and Results: The 545 study patients who underwent primary HeartMateII implantation between 2013 and 2019 were divided into 2 groups according to their diabetes mellitus (DM) status; patients with DM (n=116) and patients without DM (n=429). First, the on-device survival and incidence of adverse events were evaluated. Second, after adjusting for patients' backgrounds, the change of laboratory data in the 2 groups were compared. Overall, on-device survival at 1, 2, and 3 years was almost equivalent between the 2 groups; it was 95%, 94%, and 91% in patients without DM, and 93%, 91%m and 91% in patients with DM (P=0.468) The incidence of adverse events was similar between 2 groups of patients, except for driveline exit site infection in the adjusted cohort. Cox proportional hazards regression analysis revealed younger age (HR: 0.98 (95% confidence interval (CI): 0.97-0.99, P=0.001) and presence of DM (HR: 1.83 (95% CI: 1.14-2.88), P=0.016) as significant predictors of driveline infection. Laboratory findings revealed no differences between groups throughout the periods. CONCLUSIONS: The clinical results after LVAD implantation in DM patients were comparable with those in non-DM patients, except for the driveline exit site infection.

Lung thermography during the initial reperfusion period to assess pulmonary function in cellular ex vivo lung perfusion.

BACKGROUND: Thermography is a noninvasive technology to detect low temperatures in poorly circulated areas. In ex vivo lung perfusion (EVLP), lungs are rewarmed to body temperature during the initial 1 h. Currently, the effect of graft thermal changes during the rewarming phase on pulmonary function is unknown. In this study, we evaluated the correlation of lung surface temperature with physiological parameters, wet/dry ratio, and transplant suitability in Lund-type EVLP. METHODS: Fifteen pigs were divided into three groups: control group (no warm ischemia) or donation after circulatory death groups with 60 or 90 min of warm ischemia (n = 5, each). Thermal images of the lower lobes were continuously collected from the bottom of an organ chamber using infrared thermography throughout EVLP. RESULTS: At 8 min, lung surface temperatures of nonsuitable cases were significantly lower than in suitable cases (25.1 ± 0.6 vs. 27.8 ± 1.2°C, p < 0.001), while there was no difference in lung surface temperatures between the two groups at 0-4 min and 12-120 min. There was a significant negative correlation between lung surface temperatures at 8 min and wet/dry ratio at 2 h in the lower lobes (R = -0.769, p < 0.001, cutoff = 26°C, area under the curve = 1.0). A lung surface temperature of <26°C was significantly correlated with poor pulmonary function and transplant nonsuitability. CONCLUSION: A lung surface temperature of ≥26°C at 8 min is a good early predictor of transplant suitability in cellular EVLP and might be applicable in clinical EVLP.

Population pharmacokinetics of cefazolin before, during and after cardiopulmonary bypass in adult patients undergoing cardiac surgery.

PURPOSE: The aims of the present study were to establish a population pharmacokinetic (PPK) model of cefazolin for adult patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) and to assess the probability of target attainment (PTA) for the prophylaxis of surgical site infection (SSI) using cefazolin. METHODS: Adult patients who underwent cardiac surgery with CPB were enrolled in the prospective study. Blood samples for plasma cefazolin assay were collected, and total and unbound drug concentrations were measured and analysed using the nonlinear mixed-effects modelling (NONMEM) software considering saturable plasma protein binding. Using the PPK model, plasma unbound cefazolin concentration-time courses with current prophylaxis protocols were simulated, and the PTA for common SSI pathogens was estimated. RESULTS: A total of 199 blood samples were obtained from 27 patients. A one-compartment model with first-order elimination plus an on/off CPB compartment best described the data. The population mean for systemic drug clearance (CL) was reduced and that for the volume of distribution (V) was increased during CPB compared with the pre-CPB values. CPB-induced hypoalbuminemia was associated with reduced maximum protein binding (Bmax). The simulation studies suggested that the current dosing protocols are insufficient for attaining PTA > 0.9 throughout surgery against pathogens with minimum inhibitory concentrations (MICs) >8 mg/L. A new dosing protocol that achieves a PTA > 0.9 for pathogens with a MIC of 16 mg/L was proposed. CONCLUSION: PPK modelling with simulation may be valuable for devising a cefazolin prophylaxis protocol for patients undergoing cardiac surgery with CPB.

Novel application of indocyanine green fluorescence imaging for real-time detection of thrombus in a membrane oxygenator.

Extracorporeal membrane oxygenation (ECMO) plays an important role in the coronavirus disease 2019 (COVID-19) pandemic. Management of thrombi in ECMO is generally an important issue; especially in ECMO for COVID-19 patients who are prone to thrombus formation, the thrombus formation in oxygenators is an unresolved issue, and it is very difficult to deal with. To prevent thromboembolic complications, it is necessary to develop a method for early thrombus detection. We developed a novel method for detailed real-time observation of thrombi formed in oxygenators using indocyanine green (ICG) fluorescence imaging. The purpose of this study was to verify the efficacy of this novel method through animal experiments. The experiments were performed three times using three pigs equipped with veno-arterial ECMO comprising a centrifugal pump (CAPIOX SL) and an oxygenator (QUADROX). To create thrombogenic conditions, the pump flow rate was set at 1 L/min without anticoagulation. The diluted ICG (0.025 mg/mL) was intravenously administered at a dose of 10 mL once an hour. A single dose of ICG was 0.25mg. The oxygenator was observed with both an optical detector (PDE-neo) and the naked eye every hour after measurement initiation for a total of 8 hours. With this dose of ICG, we could observe it by fluorescence imaging for about 15 minutes. Under ICG imaging, the inside of the oxygenator was observed as a white area. A black dot suspected to be the thrombus appeared 6-8 hours after measurement initiation. The thrombus and the black dot on ICG imaging were finely matched in terms of morphology. Thus, we succeeded in real-time thrombus detection in an oxygenator using ICG imaging. The combined use of ICG imaging and conventional routine screening tests could compensate for each other's weaknesses and significantly improve the safety of ECMO.

Evaluation of real-time thrombus detection method in a magnetically levitated centrifugal blood pump using a porcine left ventricular assist circulation model.

Pump thrombosis induces significant complications and requires timely detection. We proposed real-time monitoring of pump thrombus in a magnetically levitated centrifugal blood pump (mag-lev pump) without using additional sensors, by focusing on the changes in the displacement of the pump impeller. The phase difference between the current and displacement of the impeller increases with pump thrombus. This thrombus detection method was previously evaluated through simulated circuit experiments using porcine blood. Evaluation of real-time thrombus detection in a mag-lev blood pump was performed using a porcine left ventricular assist circulation model in this study. Acute animal experiments were performed five times using five Japanese domestic pigs. To create thrombogenic conditions, fibrinogen coating that induces thrombus formation in a short time was applied to the inner surfaces of the pump. An inflow and an outflow cannula were inserted into the apex of the left ventricle and the carotid artery, respectively, by a minimally invasive surgical procedure that allowed minimal bleeding and hypothermia. Pump flow was maintained at 1 L/min without anticoagulation. The vibrational frequency of the impeller (70 Hz) and its vibrational amplitude (30 µm) were kept constant. The thrombus was detected based on the fact that the phase difference between the impeller displacement and input current to the magnetic bearing increases when a thrombus is formed inside a pump. The experiment was terminated when the phase difference increased by over 1° from the lowest value or when the phase difference was at the lowest value 12 hours after commencing measurements. The phase difference increased by over 1° in three cases. The pump was stopped after 12 hours in two cases. Pump thrombi were found in the pump in three cases in which the phase difference increased by over 1°. No pump thrombus was found in the other two cases in which the phase difference did not increase. We succeeded in real-time thrombus monitoring of a mag-lev pump in acute animal experiments.

Efficacy of multidisciplinary team approach with extracorporeal membrane oxygenation for COVID-19 in a low volume ECMO center.

Veno-venous extracorporeal membrane oxygenation (VV ECMO) is an effective and proven adjunct support for various severe respiratory failures requiring invasive mechanical ventilation and cardiovascular support. In response to the rapidly increasing number of COVID-19 patients in Japan, we launched an ECMO support team comprised of multidisciplinary experts including physicians, nurses, perfusionists, and bioethicists in preparation for the threat of a pandemic. From April 2 to July 15, 2020, Tokyo Medical and Dental University hospital treated 104 PCR confirmed COVID-19 patients. Among those, 34 patients were admitted to intensive care unit (ICU) and 5 patients required VV ECMO. All management related to ECMO was decided by the ECMO support team in addition to participation of the ECMO support team in daily multidisciplinary rounds in the ICU. Median age was 54 years old. Duration from onset to mechanical ventilation (MV) and MV to ECMO were 8 and 7 days, respectively. Four patients (80%) were successfully weaned off from ECMO. One patient died after 81 days of ECMO run. Four patients were discharged and recovered to their prehospital quality of life without major disability. We achieved a high survival rate using ECMO in our low volume ECMO institution during the COVID-19 pandemic. Multidisciplinary decision-making and a team approach for the unclear pathology with an emerging infectious disease was effective and contributed to the survival rate.

Predictors associated with clinical improvement of SARS-CoV-2 pneumonia.

BACKGROUND: There are few agents that have been proven effective for COVID-19. Predicting clinical improvement as well as mortality or severity is very important. OBJECTIVES: This study aimed to investigate the factors associated with the clinical improvement of COVID-19. METHODS: Overall, 74 patients receiving treatment for COVID-19 at Tokyo Medical and Dental University Hospital from April 6th to May 15th, 2020 were included in this study. Clinical improvement was evaluated, which defined as the decline of two levels on a six-point ordinal scale of clinical status or discharge alive from the hospital within 28 days after admission. The clinical courses were particularly investigated and the factors related to time to clinical improvement were analyzed with the log-rank test and the Cox proportional hazard model. RESULTS: Forty-nine patients required oxygen support during hospitalization, 22 patients required invasive mechanical ventilation, and 5 patients required extracorporeal membrane oxygenation. A total of 83% of cases reached clinical improvement. Longer period of time from onset to admission (≥10 days) (HR, 1.057; 95% CI, 1.002-1.114), no hypertension (HR, 2.077; 95% CI, 1.006-4.287), and low D-dimer levels (<1 µg/ml) (HR, 2.372; 95% CI, 1.229-4.576) were confirmed to be significant predictive factors for time to clinical improvement. Furthermore, a lower SARS-CoV-2 RNA copy number was also a predictive factor for clinical improvement. CONCLUSIONS: Several predictors for the clinical improvement of COVID-19 pneumonia were identified. These results may be important for the management of COVID-19 pneumonia.

Bridge-to-Bridge Left Ventricular Assist Device Implantation Strategy vs. Primary Left Ventricular Assist Device Implantation Strategy.

BACKGROUND: The bridge-to-bridge (BTB) strategy, a conversion to durable left ventricular assist device (LVAD) after stabilization using surgical temporary mechanical circulatory supports for a couple of months, is not uncommon in Japan. However, its effect on clinical outcomes in comparison with a primary durable LVAD implantation strategy remains unknown.Methods and Results:Data of 837 consecutive patients (median age 45, 73% males) who underwent durable LVAD implantation as BTB (n=168) or primary implant (n=669) between April 2011 and April 2019 were retrospectively reviewed from the prospective multicenter Japanese mechanically assisted circulatory support registry. The BTB group was younger and had comparable end-organ function, better hemodynamic profile, and longer operative time compared with the primary implant group at baseline. The 3-year survival was 80% vs. 87% (P=0.007) for the BTB and primary implant groups respectively, with greater observed rates of stroke and infection as the predominant causes of death. The BTB strategy was independently associated with increased 3-year mortality (hazard ratio 2.69 [1.43-5.07], P=0.002) in addition to other significant risk factors. CONCLUSIONS: The BTB cohort had comparable baseline characteristics to the primary implant cohort at the time of durable LVAD conversion, but had lower 3-year survival. Detailed analysis clarifying the causality of this finding should improve outcomes with the BTB strategy.

Verification of a thrombus induction method at the target point inside the blood pump using a fibrinogen coating for a thrombus detection study.

Although the magnetically levitated centrifugal blood pump (mag-lev pump) is considered superior to other pumps in antithrombogenicity, thrombotic complications are still reported. Research into thrombus detection inside a mag-lev pump is very important for solving this problem. Our research group has already proposed a method to detect a thrombus inside a mag-lev pump in real time without an additional sensor, which is named the impeller vibration method. To efficiently advance our research with reproducibility, a preconditioning method to induce thrombus inside the pump was thought to be necessary. Therefore, this study aimed to develop a preconditioning method that induces thrombus formation. To verify this method, in vitro experiments for thrombus detection were performed. A mag-lev pump developed at Tokyo Institute of Technology was used. A fibrinogen solution was coated on the inner surfaces of the bottom housing to induce thrombus formation at the target point inside the pump. The thrombus is detected by utilizing the phenomenon that the phase difference between the impeller displacement and input current to the magnetic bearing increases when a thrombus is formed inside a pump. Five hundred mL of porcine blood anticoagulated with heparin sodium was circulated in the mock circuit, and protamine sulfate was administered. Flow rate (1 L/min), impeller vibrational frequency (70 Hz), and vibrational amplitude (30 µm) were set to constant. The experiment was terminated when the phase difference increased by over 2° from the minimum value. The experiments were performed in fibrinogen-coated (group F, n = 5) and non-coated pumps (group N, n = 5). In group F, thrombus formation was observed at the fibrinogen-coated point of the housing. In contrast, a relatively small thrombus was observed in varying locations such as the housing or the impeller in group N. Thrombus formation time (the time from when the phase difference takes the minimum value to when the experiment is terminated) was different between the two groups. The mean time was significantly shorter in group F (44 ± 29 minutes) than in group N (143 ± 38 minutes; p = 0.0019). Therefore, a preconditioning method that induced thrombus formation at the target point inside a blood pump was successfully developed.

Hemocompatibility-related Adverse Events Following HeartMate II Left Ventricular Assist Device Implantation between Japan and United States.

Background: Left ventricular assist device (LVAD) therapy has improved the clinical outcomes in advanced heart failure patients, however, this may differ between countries. We aimed to compare outcomes between Japanese and US LVAD cohorts. Methods: For 416 consecutive LVAD patients who received HeartMate II LVAD implantation and completed a one-year follow-up, age-matched Japanese patients (the Japanese registry for mechanically assisted circulatory support (J-MACS) group) and the US patients were compared for their clinical outcomes. Results: 154 J-MACS patients and 77 US patients were compared. Survival, free from hemocompatibility-related adverse events (HRAEs) in the J-MACS was statistically comparable with the US (75% vs. 63%, p = 0.79). J-MACS had more disabling strokes than the US (0.221 vs. 0.052/patient-year, p = 0.005), whereas there was less nonsurgical bleeding (0.045 vs. 0.117/patient-year, p = 0.024). The net hemocompatibility score was statistically comparable between the groups (1.54 vs. 1.19 points/patient, p = 0.99). Post-LVAD prothrombin time with international normalized ratio (INR) <1.5 (odds ratio 4.07) was a risk factor for HRAEs in J-MACS, whereas INR >3.0 (odds ratio 5.71) was a risk factor in the US (p < 0.05 for both). Conclusion: In the age-matched cohorts, the J-MACS group experienced more strokes, while the US group had more bleedings. "Tailor-made" therapeutic strategy might be required for each country, given the unique variation of HRAE incidence among each country.

[Surgical Management for Cardiac and Aortic Lesion Caused by Arteritis].

Arteritis is an inflammatory disease of the vessel walls, resulting in vascular damage and a wide variety of clinical symptoms and multisystem disorders. Because aneurysmal disease, coronary disease, and aortic insufficiency affect patient prognosis, surgical intervention plays an important role. Preoperatively, systemic vessels, cardiac function, and other major organs should be evaluated. Regarding the surgical technique, reinforcement of the anastomosis to the fragile aortic wall is important to prevent pseudoaneurysmal formation and prosthetic valvular detachment. As aortic root replacement, we have been applying the modified Bentall procedure with a "double fixation technique" and obtained desirable outcomes. Although endovascular repair for aneurysmal disease is one of the treatment options, its longterm efficacy remains uncertain. Postoperative control of inflammation with corticosteroids and/or immunosuppressive agents is also important for long-term management. Pseudoaneurysmal formation and prosthetic valvular detachment may occur progressively over a long period of time. To prevent these complications, strict follow-up with imaging and inflammation control should be performed.

Implication of Preoperative Existence of Atrial Fibrillation on Hemocompatibility-Related Adverse Events During Left Ventricular Assist Device Support.

BACKGROUND: Hemocompatibility-related adverse events (HRAEs) are substantial issues in patients with left ventricular assist devices (LVADs). Atrial fibrillation (AF) is associated with worse prognosis in patients with heart failure (HF), but its effect on HRAEs following LVAD implantation remain uncertain.Methods and Results:Data from the Japanese Mechanically Assisted Circulatory Support registry of consecutive patients who received HeartMate II LVADs and were followed for 1 year were retrospectively reviewed. Among 190 patients, 23 had AF and 167 had sinus rhythm. The AF group had comparable baseline characteristics with the non-AF group except for their higher age (53 vs. 42 years, P<0.001). Following LVAD implantation, most cases of AF (73%) persisted. Antiplatelet therapy, anticoagulation therapy, and LVAD speed following LVAD implantation were comparable between groups (P>0.05 for all). The 1-year survival free from HRAEs was comparable between groups (83% vs. 76%, P=0.52). Event rates of the breakdown of HRAEs were comparable between groups except for a relatively higher rate of surgically managed pump thrombosis in the AF group (0.16 vs. 0.04, incidence rate ratio 3.75, 95% confidence interval 0.87-16.1, P=0.075). These trends still remained with propensity score-matched comparison. CONCLUSIONS: Existence of AF had no effect on the development of HRAEs following LVAD implantation. The need to aggressively treat AF before or after LVAD implantation needs further investigation.

Clinical Results, Adverse Events, and Change in End-Organ Function in Elderly Patients With HeartMateII Left Ventricular Assist Device　- Japanese Multicenter Study.

BACKGROUND: Advanced age has an adverse impact on clinical results in left ventricular assist device (LVAD) patients. We compared the clinical results of patients aged >60 years with younger patients using a national Japanese database.Methods and Results:Between April 2013 and December 2016, 300 patients underwent HeartMateII implantation. Of these, 37 patients were ≥60 years at LVAD implantation, and the clinical results of these patients were compared with the other younger 263 patients. At 1 and 3 years the on-device survival was 95%, 91% in younger patients, and 85%, 75% in older patients, respectively (P=0.016), although age was not a risk factor on the multivariate analysis. There was no significant difference between the groups in incidence of various adverse events except stroke. In the propensity-matching cohort, the incidence of stroke was significantly higher in patients aged >60 years (P=0.047). In patients aged >60 years, improvement of renal function was transient and there was no improvement later than 3 months, and recovery of serum albumin level to preoperative value was delayed. CONCLUSIONS: There were significant differences in the stroke incidence and recovery of end-organ functions after LVAD implantation. This may have important implications for patient selection in future destination therapy in Japan, where quality of life is an important issue in LVAD support.

[Salvage from Extracorporeal Membrane Oxygenation due to Acute Deteriorated Heart Failure;Treatment Decision-tree Based on the Risk Factors].

BACKGROUND: Salvage rates for patients requiring extracorporeal membrane oxygenation (ECMO)due to acute cardiogenic shock remain poor due to difficulties in decision making on optical timing of ECMO removal or conversion to ventricular assist devices( VAD). METHOD: From 2005 to 2018, 37 patients supported with ECMO due to acute circulatory deterioration were referred to our department for implantation of VAD. Their outcomes were analyzed using multi-variate analysis to assess the risk factors of VAD implantation, and we adopted a new decision-tree to improve the outcomes. RESULTS: Four patients had severe cerebral complications and 2 patients suffered severe infection. Those 6 patients were withdrawn from VAD implantation. ECMO could be removed in 6 patients, but one of them underwent VAD implantation due to the intraaortic balloon pumping (IABP) -dependent circulatory condition. In total, 25 patients underwent VAD implantation. Four patients reached to heart transplantation. Six patients remain on VAD. VAD was explanted due to recovery in 2 patients. Statistically significant risk factors by multi-variate analysis on 2-year mortality were preoperative necessity of renal replacement (p=0.006) and T-Bil (p=0.051, >4.0 mg/dl). Two-year survival of patients without end-organ dysfunction was 83.3%.However, 2-year survival of patients with end-organ dysfunction was miserable (23.1%). Based on these findings, we applied to a new decision-tree with 4 steps from 2016;(1) rule out strokes and sepsis, (2) End-organ dysfunction should be treated before VAD implantation with proper management of mechanical circulatory support to recover end-organ dysfunction, (3) urgent conversion to VAD if there is no aortic valve opening, (4) conversion to VAD if cardiac functional recovery cannot be observed within 5 to 7 days. According to this decision-tree, 3 patients underwent VAD implantation after recovery from end-organ failure and survived in 2016. CONCLUSIONS: Our experiences of salvage from ECMO in patients with severely impaired cardiac function suggest that end-organ dysfunction( necessity of renal replacement and T-Bil>4.0 mg/dl) was a strong risk factor for mid-term mortality. Those patients should undergo VAD implantation after recovery from end-organ dysfunction.