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Sleep-disordered breathing (SDB) is associated with an increased risk of adverse events in patients with heart failure (HF); however, its impact in patients implanted with a left ventricular assist device (LVAD) remains unclear. We aimed to investigate the prevalence of SDB in patients with LVAD and its impact on their clinical outcomes. Fifty consecutive patients with LVAD who underwent portable sleep monitoring between September 2017 and April 2018 were prospectively enrolled, and they were followed up for 170 ± 36 days. According to their respiratory disturbance indexes (RDIs), they were categorized into the SDB group (RDI ≥ 15, n = 12) and the non-SDB group (RDI 15, n = 38). The incidence of adverse events during the follow-up period was investigated after enrollment. Multivariate logistic regression analysis revealed significant differences in SDB in LVAD-implanted patients in terms of the logarithmic transformation brain natriuretic peptide (BNP) values (p = 0.005). The optimal BNP cut-off value for SDB prediction in LVAD-implanted patients was 300 pg/mL (sensitivity: 58.3%, specificity: 94.7%). During follow-up, ventricular tachyarrhythmias (VTas) occurred significantly more frequently in the SDB group (4 [33%] vs. 2 [5%] patients, p = 0.02); Atrial tachyarrhythmia (ATa) also tended to occur more frequently in the SDB group (2 [25%] vs. 2 [2%] patients, p = 0.07). SBD was prevalent in 24% of the LVAD-implanted patients with advanced HF. Furthermore, SDB was significantly associated with high BNP levels and was also potentially associated with subsequent incidence of VTa in patients with LVAD.

Aims The outcomes of patients with hypertrophic cardiomyopathy with left ventricular systolic dysfunction (HCM‐LVSD) undergoing left ventricular assist device (LVAD) implantation remain unclear. We retrospectively evaluated the clinical impact of LVAD implantation on clinical outcomes, including haemodynamics and brain natriuretic peptide (BNP) levels, in patients with HCM‐LVSD, in comparison with those with dilated cardiomyopathy (DCM). Methods and results In this retrospective, single‐centre, observational study conducted in Japan, the medical records of patients who underwent LVAD implantation in the National Cerebral and Cardiovascular Center between 2011 and 2020 were reviewed. We enrolled 96 patients with DCM (average age: 43.5 years; 73 men) and 24 patients with HCM‐LVSD (average age: 48.3 years; 16 men). The HCM‐LVSD group had smaller left ventricles with thicker ventricular walls than the DCM group, which became more prominent after LVAD implantation. Preoperatively, BNP values were comparable between both groups; however, 3 months post‐implantation, they were significantly higher in the HCM‐LVSD group. Pulmonary artery pulsatility index, right ventricular stroke work index, and cardiac index were lower, and right atrial pressure was higher, in the HCM‐LVSD group, suggesting subclinical impairment of right ventricular function. The HCM‐LVSD group demonstrated equivalent outcomes, including overall survival, cerebrovascular accidents, right ventricular failure, LVAD‐related infections, arrhythmia, and aortic insufficiency, post‐implantation. Conclusions Despite a decreased right ventricular function with higher BNP values, patients with HCM‐LVSD and DCM showed comparable outcomes post‐LVAD implantation.

Acquired coarctation of the aorta (CoA) following total aortic arch replacement (TAR) is a rare complication inducing left ventricular (LV) dysfunction probably due to increased LV afterload and secondary hypertension caused by increased upper body and decreased renal blood flow. We describe a case of a 35-year-old male who developed atypical CoA with severe LV dysfunction with LV ejection fraction of 10%, but without secondary hypertension after TAR using conventional elephant trunk (ET) technique for acute aortic dissection. Computed tomography revealed near-occlusive CoA due to narrowed distal ET. Because the myocardial histological findings were mild, and he had no cardiac failure history, we determined that LV function might be reversible. He underwent thoracic endovascular aortic repair (TEVAR), resulting in restored LV function. However, as the descending aortic false lumen distally to the end of ET was rapidly dilated, probably due to increased cardiac output and lower body blood flow, he underwent descending aortic replacement 3 months after TEVAR. In conclusion, a narrowed distal ET may cause LV dysfunction early after TAR, even without secondary hypertension. TEVAR may be a useful therapeutic option for a narrowed distant ET but can induce distal aortic dilatation.

Background Implantable left ventricular assist devices (LVAD) have improved quality of life and survival in patients with advanced heart failure. However, LVAD-specific infections and predicting which patients will develop infections remain challenging. This study investigated whether changes in body mass index (BMI) during hospitalization following LVAD implantation are associated with LVAD-specific infections within 1 year of implantation.Methods and Results:Patients (n=135) undergoing LVAD implantation were retrospectively divided into 2 groups based on changes in BMI from LVAD implantation to discharge: those with and without decreases in BMI. Each group was further subdivided according to baseline albumin concentrations (high [>3.7 g/dL] and low [≤3.7 g/dL]). Twenty patients developed LVAD-specific infections within 1 year. Receiver operating characteristic curve analysis resulted in a ∆BMI cut-off of less than -0.128 kg/m2. In multivariate analysis, younger patients and those with decreases in BMI had significantly higher rates of LVAD-specific infection (P=0.010 and P=0.035, respectively). LVAD-specific infection rates were significantly higher for patients with low albumin and decreases in BMI than for patients with low albumin but no decrease in BMI. Conclusions Decreases in BMI during hospitalization after LVAD implantation and younger age were independently associated with LVAD-specific infection within 1 year. Strict patient management may be needed to avoid decreases in BMI during hospitalization after LVAD implantation, particularly in patients with low baseline albumin concentrations.

Background In Japan, patients with heart failure who have a paracorporeal left ventricular assist device (pLVAD) and cannot be weaned from the VAD may undergo conversion to implantable continuous-flow LVAD (iLVAD) via a bridge-to-bridge (BTB) strategy for bridge-to-transplantation (BTT). This study aimed to evaluate the real-world clinical status of BTB strategies. Methods Among 134 patients who underwent iLVAD implantation for BTT, 34 patients underwent conversion from pLVAD to iLVAD (BTB group) and 100 patients underwent iLVAD implantation primarily (primary iLVAD group). The clinical characteristics and outcomes were compared between the two groups. Results No significant difference was found in the overall survival between the two groups (p = 0.26; log-rank test). However, the 1-year survival rate and the 1-year freedom from the composite events of death, stroke, systemic infection, and bleeding rate were lower in the BTB group than in the primary iLVAD group (survival rate, 88.2% vs. 99.0%, p = 0.0040; composite event-free survival rate, 26.1% vs. 49.8%, p = 0.030; log-rank test). Multivariate analysis indicated that the BTB strategy [hazard ratio (HR) 1.70, 95% confidence intervals (CI) 1.03–2.72; p=0.036] and serum total bilirubin levels at iLVAD implantation [HR 1.31, 95% CI 1.00–1.65; p=0.043] were independent predictors of 1-year composite events. Conclusions The BTB strategy is useful in providing long-term survival in patients with acute critical diseases. However, the early mortality rate after conversion is higher in patients who underwent the BTB strategy.

Background Appropriate indications and protocols for induction therapy using basiliximab have not been fully established in heart transplant (HTx) recipients. This study elucidated the influence of induction therapy using basiliximab along with delayed tacrolimus (Tac) initiation on the outcomes of high-risk HTx recipients.Methods and Results:A total of 86 HTx recipients treated with Tac-based immunosuppression were retrospectively reviewed. Induction therapy was administered to 46 recipients (53.5%) with impaired renal function, pre-transplant sensitization, and recipient- and donor-related risk factors (Induction group). Tac administration was delayed in the Induction group. Induction group subjects showed a lower cumulative incidence of acute cellular rejection grade ≥1R after propensity score adjustment, but this was not significantly different (hazard ratio [HR]: 0.63, 95% confidence interval [CI]: 0.37-1.08, P=0.093). Renal dysfunction in the Induction group significantly improved 6 months post-transplantation (P=0.029). The cumulative incidence of bacterial or fungal infections was significantly higher in the Induction group (HR: 10.6, 95% CI: 1.28-88.2, P=0.029). Conclusions These results suggest that basiliximab-based induction therapy with delayed Tac initiation may suppress mild acute cellular rejection and improve renal function in recipients with renal dysfunction, resulting in its non-inferior outcome, even in high-risk patients, when applied to the appropriate recipients. However, it should be carefully considered in recipients at a high risk of bacterial and fungal infections.

Background Continuous-flow left ventricular assist device (CF-LVAD) substantially improves survival in endstage heart failure patients. However, bleeding complications are common after CF-LVAD implantation and in some cases, re-exploration for bleeding is needed. We aimed to investigate the incidence, timing, and risk factors of bleeding requiring re-exploration after CF-LVAD implantation.Methods and Results:We retrospectively reviewed 162 consecutive patients (age 43±13 years, 71% men) who underwent CF-LVAD implantation (HeartMateII 119, Jarvik2000 15, HVAD 13, EVAHEART 10, DuraHeart 5) from January 2012 to June 2019. During follow-up [median 662 days, interquartile range (IQR) 364-1,116 days], 35 (21.6%) experienced re-exploration for bleeding. The median timing of re-exploration was 6 (IQR 1-10) days. In the multivariate logistic regression analysis, postoperative platelet count was an independent predictor for re-exploration for bleeding after CF-LVAD implantation (per 104/μL: odds ratio 0.83, 95% confidence interval 0.74-0.93, P=0.002). Patients who experienced re-exploration for bleeding had a significantly worse survival rate than patients who did not (at 4 years, 73.6% vs. 90.1%, P=0.039). Conclusions Re-exploration for bleeding is prevalent after CF-LVAD implantation, especially in patients with low postoperative platelet counts. As bleeding requiring re-exploration is associated with poor prognosis, risk stratification using the postoperative platelet count may be beneficial for these patients.

BACKGROUND Sarcopenia is characterized by progressive loss of skeletal muscle and has frequently been associated with poor clinical outcomes in patients with advanced heart failure (HF). The urinary creatinine excretion rate (CER) index is an easily measured marker of muscle mass, but its predictive capacity for mortality and cerebrovascular events has not been investigated in patients with a continuous-flow implantable left ventricular assist device (CF-iLVAD).Methods and Results:We retrospectively reviewed 147 patients (mean [±SD] age 43.7±12.5 years, 106 male) who underwent CF-iLVAD implantation between April 2011 and June 2019. CER indices in 24-h urine samples before CF-iLVAD implantation were determined. Over a median follow-up of 2.3 years, there were 10 (6.8%) deaths and 43 (29.3%) cerebrovascular events. Patients were divided into 2 groups (low and high CER index) according to the median CER index in men and women (i.e., 13.71 and 12.06 mg·kg-1·day-1, respectively). Mortality and intracranial hemorrhage rates after CF-iLVAD implantation were significantly higher in the low than high CER index group (mortality 12.3% vs. 1.4% [P

Background The therapeutic strategy for giant cell myocarditis (GCM) remains controversial, so we reviewed the clinical status of Japanese patients with GCM.Methods and Results:We retrospectively reviewed 6 consecutive patients with GCM requiring percutaneous mechanical circulatory support (p-MCS), with 3 further requiring ventricular assist devices. One patient died during p-MCS. Cardiac function improved in the other 5 with immunosuppressive therapy, but only 3 patients treated with dual immunosuppressants, including cyclosporine (CyA), achieved >1-year survival. Conclusions The prognosis of patients with fulminant GCM is poor, but a treatment that combines MCS and early administration of CyA-based immunosuppressants will be useful.

Patients with cardiogenic shock (CS) needing temporary circulatory support (TCS) have poor survival rates after implantation of durable ventricular assist device (dVAD). We aimed to characterize post-dVAD adverse event burden and survival rates in patients requiring pre-operative TCS.We analyzed 13,511 adults (Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS] Profiles 1-3) with continuous-flow dVADs in International Society for Heart and Lung Transplantation Registry for Mechanically Assisted Circulatory Support (2013-2017) according to the need for pre-operative TCS (n = 5,632) vs no TCS (n = 7,879). Of these, 726 (5.4%) had biventricular assist devices (BiVAD). Furthermore, we compared prevalent rates (events/100 patient-months) of bleeding, device-related infection, hemorrhagic and ischemic cerebrovascular accidents (hemorrhagic cerebral vascular accident [hCVA], and ischemic cerebral vascular accident [iCVA]) in early (3 months) and late (≥3 months) post-operative periods.TCS included extracorporeal membrane oxygenation (ECMO) (n = 1,138), intra-aortic balloon pump (IABP) (n = 3,901), and other TCS (n = 593). Within 3 post-operative months, there were more major bleeding and cerebrovascular accidents (CVAs) in patients with pre-operative ECMO (events/100 patient-months rates: bleeding = 19, hCVA = 1.6, iCVA = 2.8) or IABP (bleeding = 17.3, hCVA = 1.5, iCVA = 1.5) vs no TCS (bleeding = 13.2, hCVA = 1.1, iCVA = 1.2, all p0.05). After 3 months, adverse events were lower and similar in all groups. Patients with ECMO had the worst short- and long-term survival rates. Patients with BiVAD had the worst survival rate regardless of need for pre-operative TCS. CVA and multiorgan failures were the common causes of death for patients with TCS and patients without TCS.Patients requiring TCS before dVAD had a sicker phenotype and higher rates of early post-operative adverse events than patients without TCS. ECMO was associated with very high early ischemic stroke, bleeding, and mortality. The extreme CS phenotype needing ECMO warrants a higher-level profile status, such as INTERMACS "0."

Gastrointestinal bleeding (GIB) is among the major complications affecting implantable continuous-flow left ventricular assist device (iLVAD) recipients and is the major cause of re-hospitalization. GIB in iLVAD recipients is sometimes critical, and controlling bleeding using conventional approaches is difficult. A 35-year-old woman developed refractory GIB from multiple gastric polyps and de novo angiodysplasia after Jarvik2000® iLVAD implantation. Discontinuation of anticoagulation and antiplatelet therapies had little effect on GIB; thus, multiple endoscopic hemostatic therapies were performed. However, bleeding recurred several times, and red blood cell (RBC) transfusion in large volumes was required for progressive anemia. Furthermore, the von Willebrand factor (VWF) multimer analysis revealed loss of the high-molecular weight multimer, which may have resulted from the high-speed rotation of the axial-flow LVAD pump. To supplement VWF, cryoprecipitate was administered, but it was effective for only several days. Finally, the patient was treated with octreotide, a somatostatin analog, on post-operative day 58. After starting octreotide, tarry stool gradually decreased, and progression of anemia slowed down within the first 14 days of treatment; thus, the total RBC transfusion volume was reduced without additional hemostatic interventions, including cryoprecipitate administration. The patient developed mediastinitis on post-operative day 68 and died of sepsis on post-operative day 72. There was no adverse effect associated with octreotide use. Although the observation period was short, octreotide appears to be useful for resolving recurrent GIB after iLVAD implantation and reducing blood transfusions.

Danon disease is an extremely rare inherited disorder characterized by cardiac involvement, myopathy, and intellectual disability. As patients with Danon disease die at an early age, mainly as a result of cardiac involvement, implantation of a left ventricular assist device (LVAD) and/or heart transplantation are essential options. However, various comorbidities associated with Danon disease should be assessed when these patients are being considered as potential heart transplant candidates. We report the case of an adult male patient with dilated-phase hypertrophic cardiomyopathy secondary to Danon disease, who received an LVAD as a bridge to transplantation.

Background Because of aggressive immunosuppression, heart transplant recipients have a high risk of de novo malignancy, which is a major cause of death and worse prognosis, regardless of the type. However, the impact of de novo malignancy on Japanese heart transplant recipients is unknown. Methods We analyzed 103 Japanese heart transplant recipients over 18-years-old at the time of transplantation between April 1999 and April 2017. Patient characteristics and prognosis were compared between heart transplant recipients with or without de novo malignancy after heart transplantation (HTx). Additionally, univariate and multivariate analyses for the risk factors of de novo malignancy after HTx were performed. Results De novo malignancy developed in 7 patients (6.8%; post-transplant lymphoproliferative disorders, n = 3; Bowen's disease, n = 1; colon cancer, n = 2; bladder cancer, n = 1). Follow-up time and previous antibody mediated rejection (AMR) ≥ grade 1 were risk factors of de novo malignancy after HTx in multivariate analysis (OR: 1.19, 95% CI: 1.00–1.42, p = 0.043; and OR: 10.7, 95% CI: 1.37–83.68, p = 0.038, respectively). History of malignancy was a potential risk factor, albeit not significant (OR: 23.05, 95% CI: 0.99–534.53, p = 0.071). The survival rates in patients with de novo malignancy was significantly lower than in those without de novo malignancy (3-year survival rate: 100% versus 67%, p = 0.0025). Conclusions Long follow-up time and previous AMR ≥ grade 1 were risk factors of de novo malignancy after HTx. Japanese heart transplant recipients with de novo malignancy have worse prognosis; therefore, screening examinations are important for early diagnosis.

BACKGROUND In patients with chronic heart failure with reduced ejection fraction (HFrEF), cardiac resynchronization therapy (CRT) improves left ventricular ejection fraction (LVEF) and exercise-based cardiac rehabilitation (ECR) enhances exercise capacity. This study examined the relationship between the 2 responses.Methods and Results:Sixty-four consecutive HFrEF patients who participated in a 3-month ECR program after CRT were investigated. Patients were categorized according to a median improvement in peak oxygen uptake (PVO2) after ECR of 7% as either good (n=32; mean percentage change in PVO2[%∆PVO2]=23.2%) or poor (n=32; mean %∆PVO2=2.5%) responders. There was no significant difference in baseline characteristics between the good and poor responders, except for PVO2(51% vs. 59%, respectively; P=0.01). The proportion of good CRT responders was similar between the good and poor responders (%∆LVEF ≥10%; 53% vs. 47%, respectively; P=NS). Overall, there was no significant correlation between %∆LVEF after CRT and %∆PVO2after ECR. Notably, among poor CRT responders (n=32), the prevalence of atrial fibrillation (0% vs. 29%; P

OBJECTIVES Fulminant myocarditis with cardiogenic shock requires extracorporeal life support (ECLS) and has poor outcomes. To improve outcomes, we have converted patients with severely impaired cardiac and multiorgan function from peripheral to central ECLS. In this study, we reviewed these patients’ clinical outcomes and investigated associated factors. METHODS We retrospectively studied 70 consecutive patients with fulminant myocarditis under peripheral support from 2006 to 2020. Forty-eight patients underwent surgical conversion to central support, and the remaining patients continued peripheral support. The end point was survival and ventricular assist device-free survival. RESULTS More severe pulmonary congestion and multiorgan failure were present in patients with central than peripheral support. Weaning from ECLS was achieved in 95% and 62% of patients with peripheral and central support, respectively. Five-year survival was not significantly different between patients with central and peripheral support (71.2% vs 87.5%, respectively; P = 0.15). However, the ventricular assist device-free survival rate was significantly higher in patients with central than peripheral support (82.2% vs 52.0%, respectively; P = 0.017). A peak creatine kinase-MB level of >180 IU/l, rhythm disturbance and aortic valve closure were detrimental to functional recovery in patients with central support. CONCLUSIONS Conversion to central ECLS is feasible and safe in patients with fulminant myocarditis. Patients with severe myocardial injury as shown by a high creatine kinase-MB level, rhythm disturbance and aortic valve closure should be converted to a durable left ventricular assist device.

Background Bridge-to-decision (BTD) devices providing temporary mechanical circulatory support should be introduced to patients with advanced heart failure. This study evaluated the effectiveness and safety of a BTD device comprising an innovative extracorporeal continuous-flow temporary ventricular assist device (VAD) driven by a novel hydrodynamically levitated centrifugal flow blood pump.Methods and Results:Nine patients, comprising 3 with dilated cardiomyopathy, 3 with fulminant myocarditis, and 3 with ischemic heart disease, and 6 males, whose mean age was 47.7±8.1 years, were enrolled into the study. Six patients had Interagency Registry for Mechanically Assisted Circulatory Support profile 1, and 3 were profile 2. The primary endpoint was a composite of survival free from device-related serious adverse events and complications during circulatory support. Eight patients received left ventricular support, of whom 3 received concomitant right ventricular support using extracorporeal membrane oxygenation circuits, as a consequence of severe respiratory failure. One patient with fulminant myocarditis received biventricular support using the novel VAD system. After 19.0±13.5 days, 3 patients were weaned from circulatory support, because their native cardiac function recovered, and 6 patients required conversion to a durable device as a bridge-to-transplantation. One patient had non-disabling ischemic stroke episodes, and no patients died. Conclusions This novel extracorporeal VAD system with a hydrodynamically levitated centrifugal pump can safely and successfully bridge patients with advanced heart failure to subsequent therapeutic stages.

Background During these 2 decades (1999-2019), many therapeutic strategies have been developed in the field of heart transplant (HTx) to improve post-HTx outcomes. In the present study, 116 consecutive HTx adults between 1999 and 2019 were retrospectively reviewed to evaluate the influences of a therapeutic modification on post HTx outcomes.Methods and Results:Patient survival, functional status and hemodynamics after HTx and modification of therapeutic strategies were reviewed. The overall cumulative survival rate at 10 and 20 years post-HTx was 96.4 and 76.7%, respectively. There were no significant differences in survival rate or exercise tolerance after HTx between extracorporeal and implantable continuous flow-LVAD. Post-HTx patient survival in patients, irrespective of the donor risk factors such as donor age, low LVEF, history of cardiac arrest, was equivalent across cohorts, while longer TIT and higher inotrope dosage prior to procurement surgery were significant risk factors for survival. In 21 patients given everolimus (EVL) due to renal dysfunction, serum creatinine significantly decreased 1 year after initiation. In 22 patients given EVL due to transplant coronary vasculopathy (TCAV), maximum intimal thickness significantly decreased 3 years after initiation. Conclusions The analysis of a 20-year single-center experience with HTx in Japan shows encouraging improved results when several therapeutic modifications were made; for example, proactive use of donor hearts declined by other centers and the use of EVL in patients with renal dysfunction and TCAV.

BACKGROUND Low body mass index (BMI) is a relevant prognostic factor for heart failure (HF), but HF patients with low BMI are reported to be at risk of not receiving optimal drug treatment. We sought to evaluate the efficacy of cardiac rehabilitation (CR) in patients with low vs. normal BMI. Methods and Results: We studied 152 consecutive patients (low BMI, n=32; normal BMI, n=119) who participated in a 3-month CR program. Low BMI was defined as

We hypothesized that the externalizing direction of the driveline (the driveline angle) at the percutaneous exit site would influence the occurrence of driveline infection after left ventricular assist device implantation. From August 2013 to May 2017, 71 patients were implanted with a HeartMate II device in our center. The driveline angle was measured on anteroposterior radiography just after implantation. Risk factors for driveline infection were analyzed by uni- and multivariate analyses. Driveline infection developed in 10 (14%) patients during follow-up. Overall actual freedoms from driveline infection at 6, 12, and 24 months were 96%, 88%, and 86%, respectively. Overall number of driveline infection events per patient-year was 0.16. Receiver operating characteristic analysis determined the cut-off point of the driveline angle as 41°. The 6-, 12-, and 24-month actuarial freedoms from driveline infection in those with driveline angle more than 42° (84%, 74%, and 74%, respectively) were significantly lower than in those with driveline angle less than 41° (97%, 94%, and 90%, respectively; p

Purpose Left ventricular assist devices (LVADs) have emerged as an important treatment option for bridging patients with heart failure to transplant. LVADs have shown improved survival; however, the impact of LVAD type on the quality of life (QoL) while on long-term LVAD support is unknown. We aimed to evaluate the QoL of patients while supported with a LVAD in Japan. Methods 299 patients enrolled in the Japanese Registry for Mechanically Assisted Circulatory Support (J-MACS), who were listed for transplant or likely to be listed, received a LVAD from 2010 to 2018 and had full QoL data, were enrolled. QoL data, such as visual analogue scale (VAS) and EQ-5D-3L by 5 dimensions (5D: mobility, self-care, usual activities, pain/discomfort and anxiety/depression) before and at 3- and 12-months after implantation of a LVAD were obtained from the J-MACS Registry. These patients were divided into 3 groups; primary implantable LVAD (iLVAD) (N=263), primary paracorporeal LVAD (pLVAD) (N=9) and bridge from paracorporeal to implantable LVAD (BTB) (N=27). Results VAS in all groups significantly increased from before to 3- and 12-months after LVAD implantation(p Conclusion QoL as VAS and 5D were significantly improved after implantation of any LVAD type. However, VAS and 5D except anxiety/depression in patients with pLVAD were significantly lower and more problems than those in patients with iLVAD. These differences were eliminated by converting from pLVAD to iLVAD. BTB might be a beneficial treatment option to improve QoL as well as patient's survival.

Purpose Left ventricular assist device (LVAD) has been reported to improve pulmonary hypertension (PH) due to left heart disease (PH-LHD). However, prevalence of combined post- and pre-capillary PH (Cpc-PH) in patients with PH-LHD and the impact of LVAD implantation on Cpc-PH has not been fully elucidated. This study aimed to investigate hemodynamic changes following LVAD implantation in patients with PH-LHD to assess pulmonary vascular reverse remodeling. Methods Eighty-nine patients with advanced heart failure complicated by PH-LHD undergoing LVAD implantation who received serial right heart catheterizations at least 3 time points (before, early after, and 1-year after implantation) were retrospectively reviewed. Patients were divided into 2 groups as Cpc-PH group (n=50): pulmonary vascular resistance (PVR) > 3 Wood unit (WU) or diastolic pulmonary pressure gradient (DPG) ≥ 7 mmHg, and isolated post-capillary PH (Ipc-PH) group (n=39). Results Values of brain natriuretic peptide and transaminase in Cpc-PH group were higher than those in Ipc-PH group. Cpc-PH patients were consisted of 41 with PVR > 3 WU, 8 with PVR > 3 WU and DPG ≥ 7 mmHg, and 1 with DPG ≥ 7 mmHg preoperatively. Median values of PVR in both groups significantly decreased early after LVAD implantation [from 4.1 to 2.7 WU (p 3 WU (n=14) or DPG ≥ 7 mmHg (n=1) at that point. Among these 15 patients, 4 patients still remained on their PVR > 3 WU (n=3) or DPG ≥ 7 mmHg (n=1) even 1-year after LVAD implantation. PVR and DPG in these 4 patients turned to normal values at 3-year after implantation. Conclusion Over half of patients with PH-LHD were complicated by Cpc-PH in our study cohort. LVAD implantation readily improved hemodynamics regardless of complication of Cpc-PH, whereas 15 patients were still found to be PVR > 3 WU or DPG ≥ 7 mmHg which should be considered as persistent Cpc-PH. We speculate that most of Cpc-PH in patients with PH-LHD might be caused by alteration of vascular tone which will be promptly relieved by substantial left ventricular unload, however a certain number of patients with Cpc-PH might develop structural remodeling of pulmonary vasculature which requires months or years to achieve pulmonary vascular reverse remodeling.

Purpose An extracorporeal centrifugal-flow left ventricular assist device (CF-E-LVAD) system (BR16010) was newly developed. Since implantation of the durable implantable LVAD (I-LVAD) is still controversial in patients with cardiogenic shock or refractory heart failure because of its significant inferiority of outcomes as compared with higher INTERMACS profile patients, short-term E-LVADs have been still clinically important for bridging strategy for the next definitive treatment. Our aim of this study was to evaluate the influence of the novel developed CF-E-LVAD on the clinical prognosis in patients with bridging strategy, as compared with conventional extracorporeal pulsatile flow LVAD (PF-E-LVAD). Methods We retrospectively reviewed the medical records of 62 patients who were implanted E-LVAD as bridging strategy from April 2011 to January 2019. Six patients (9.7%) were implanted CF-E-LVAD. The clinical prognosis until 30 days after E-LVAD implantation, and the change of cardiac function and laboratory data at the early follow up were evaluated. Results Improvement of left ventricular ejection fraction was significantly greater in the CF-E-LVAD group than in the PF-E-LVAD group (217.9 [147.8 to 335.3] vs 38.3 [-21.7 to 128.8] %, P=0.010). Serum total bilirubin level significantly improved in CF-E-LVAD group than in the PF-E-LVAD group (-7.9 [-33.3 to 82.4] vs 68.8 [10.0 to 202.1] %, P=0.041). Although clinical courses, including death, cerebrovascular accidents and re-thoracotomy due to removal of mediastinal hematoma, were no significant difference between two groups, almost half (54.5%) in the PF-E-LVAD group was still ongoing the E-LVAD support at the 30 days post-E-LVAD implantation while only one patient (16.7%) was supported with E-LVAD in the CF-E-LVAD group. Conclusion The novel developed CF-E-LVAD system might influence on the earlier recovery of cardiac function and the multiple organ failure, and lead to the earlier decision for next definitive strategy.

Purpose Heparin-induced thrombocytopenia (HIT) is an immune-mediated condition associated with thrombocytopenia and thrombotic complications. The condition is increasingly recognized in hospitalized patients including severely injured trauma patients. Because these patients may eventually be considered for organ donation, management of the HIT screen positive donor has become an important issue in transplant surgery. We describe the recent management of 2 cardiac allograft donors with HIT. Methods At organ recovery, both male adult donors were hemodynamically stable with a normal appearing heart and no evidence of thrombosis. The donor underwent a routine multiple organ allograft recovery with argatroban infused over 15 minutes immediately before aortic cross-clamping after confirming activated clotting time (ACT) of greater than 400 sec. The cardiac allograft was flushed in the donor operating room with a total of 4 liters of cold Celsior solution. These hearts were transplanted in patients with dilated cardiomyopathy and cardiac sarcoidosis by modified bicaval anastomosis technique using heparin for anticoagulation therapy during cardiopulmonary support. Both were bridged with implantable left ventricular assist device (Heart Mate II and Jarvik 2000, respectively). Results This management strategy resulted in successful multiple organ transplants (Case 1: heart, two single lungs, liver, 2 kidney, case 2: heart, bilateral lung, liver, pancreas, 2 kidneys). Neither of the heart and other recipients demonstrated signs or symptoms of HIT, or neither had any postoperative thrombotic complications.. Conclusion Based on this experience, a treatment algorithm for managing HIT donors using argatroban is proposed for heart donors as well as other organ donors

This study aimed to compare the hemodynamic performance and clinical results of the EVAHEART and HeartMate II left ventricular assist devices (LVADs). From 2007 to 2016, fourteen patients received EVAHEART and 28 received HeartMate II at our center. Early survival, driveline infection, and neurologic events were evaluated. Hemodynamic performance was evaluated with transthoracic echocardiography and right heart catheterization. Mean follow-up was 35.5 ± 14.8 months for EVAHEART and 29.8 ± 6.5 months for HeartMate II. Survival rates were comparable between the two groups. After 24 months, freedom from driveline infection was 28% with EVAHEART, and 85% with HeartMate II; freedom from neurologic events was 21% with EVAHEART, and 89% with HeartMate II. Serum lactate dehydrogenase was significantly lower with EVAHEART. There was a significantly greater decrease in left ventricular size with HeartMate II. In catheter examination performed 1 month postoperatively, HeartMate II recipients had significantly lower pulmonary capillary wedge pressure and mean pulmonary pressure, despite a comparable cardiac index. Both devices provided excellent clinical results and hemodynamic performance. HeartMate II could be a better choice to avoid driveline infection and neurologic events. Our results suggest that HeartMate II reduced right ventricular afterload. However, further analysis of more cases is required.

Background This study aimed to clarify the prognostic impact of partial pressure of end-tidal carbon dioxide (PETCO 2 ) in patients with advanced chronic heart failure (HF). Methods Forty-eight patients (mean age 43.1±11.9years, 32 males) with chronic HF (44 with non-ischemic and 4 with ischemic cardiomyopathy) were prospectively enrolled. Echocardiography, blood tests, pulmonary function testing, and PETCO 2 measurements were performed as noninvasive tests, whereas right heart catheterization and arterial blood gas analysis were conducted as invasive tests. The primary end point of this study was left ventricular assist device (LVAD) implantation or cardiac death. Results Eighteen patients underwent LVAD implantation at the Interagency Registry for Mechanically Circulatory Support (INTERMACS) profile 3 during the follow-up period, and no patient died. PETCO 2 was significantly lower in a stepwise manner with New York Heart Association functional class (class I or II, 34.2±9.3mmHg vs. class III or IV, 27.7±2.5mmHg; p 2 ≤31mmHg is an independent noninvasive predictor of LVAD implantation. Univariable and multivariable linear regression analyses showed that pulmonary arterial pressure was independently and highly correlated with PETCO 2 ( r 2 =−0.512, p Conclusions Among various noninvasive clinical parameters investigated, PETCO 2 was the independent predictor of LVAD implantation at the INTERMACS profile 3 in patients with chronic HF. Pulmonary congestion may significantly contribute to decreases in PETCO 2 in patients with HF.

Background Late renal function dysfunction is an increasingly recognized complication in continuous flow left ventricular assist device (CF-LVAD) patients. Although hemolysis is prevalent in CF-LVAD patients and hemolysis may deteriorate renal function, the influence of persistent hemolysis on renal function in CF-LVAD patients remains to be investigated. Purpose To investigate the influence of persistent hemolysis on renal function in CF-LVAD patients, using lactate dehydrogenase (LDH) as a sensitive marker of hemolysis. Methods Excluding patients who died or underwent pump exchange for pump thrombosis, we retrospectively reviewed 65 consecutive adults who underwent HeartMateII implantation in our center from May 2011 to October 2017. Patient characteristics, chronotropic change of estimated glomerular filtration rate (eGFR) and LDH values weekly for 4 weeks and every 4 weeks between 4 and 48 weeks after implantation were collected. Then, calculating mean LDH during 48 weeks after implantation, study population was divided into low and high mean LDH groups at the median value of mean LDH. Results The median value of mean LDH was 304 U/l. Compared with low LDH patients, though high LDH patients were more likely female and had smaller body surface area, there were no significant difference in pre-operative eGFR between the groups (66.0±23.7 vs. 70.2±25.7 ml/min/1.73m2, p=0.495). After 40 weeks after implantation, high LDH patients had significantly lower eGFR than low LDH patients (71.0±23.7 vs. 87.1±31.4 ml/min/1.73m2, p=0.024). In multivariate linear regression analysis, mean LDH [parameter estimate: −0.10 (95% CI: −0.17 to −0.04), p=0.003] and post-operative pulse pressure [parameter estimate: 0.71 (95% CI: 0.05 to 1.37), p=0.036] were significantly associated with eGFR change during 48 weeks after HeartMateII implantation. Univariate and multivariate linear regression analysis for eGFR change Univariate parameter estimate 95% CI p value Multivariate parameter estimate 95% CI p value Bilirubin, mg/dl 9.97 3.82 to 16.13 0.002 6.55 −0.43 to 13.53 0.065 BNP, pg/ml 0.01 0.00 to 0.02 0.044 0.00 −0.01 to 0.01 0.528 Mean LDH during 4 to 48 weeks, U/l −0.11 −0.18 to −0.05 Conclusions High mean LDH and low pulse pressure were associated with a significant decrease in eGFR late after HeartMateII implantation. Subclinical persistent hemolysis may be associated with late renal function deterioration in CF-LVAD patients.

Conversion from peripheral extracorporeal life support (ECLS) to the central one can improve and stabilize hemodynamics in patients with refractory congestive heart failure-related multiorgan failure, whereas indication and selection of the type of the central ECLS have not been fully established. Institutional outcome of the conversion therapy was herein reviewed to verify indication and selection of three types of central ECLS. This study enrolled an institutional consecutive surgical series of 24 patients with refractory congestive heart failure under peripheral ECLS, related to fulminant myocarditis (n = 15), dilated cardiomyopathy (n = 5), or acute myocardial infarction (n = 4). They were converted to central Y-extracorporeal membrane oxygenation (ECMO, n = 6), extracorporeal ventricular assist device (EC-VAD, n = 12), or pump catheter (n = 6), dependent upon the degree of multiorgan failure. Despite the different degree of multiorgan failure prior to the conversion, improvement in end-organ perfusion and reduction in right atrial and pulmonary artery pressure were promptly achieved regardless of the type of the central ECLS. There were five in-hospital mortalities (21%) during the central ECLS, whereas mechanical support was weaned-off in 11 cases (46%) and durable LVAD was subsequently implanted for bridge to transplantation in eight cases (33%). Conversion from the peripheral ECLS to the central ones, such as central Y-ECMO, EC-VAD or pump catheter, promptly established a sufficient support with heart and lung unloading in patients with refractory congestive heart failure.

Background The Japanese registry for mechanical assisted circulatory support (J-MACS) is a prospective registry to collect all data of implantable left ventricular assist device (LVAD) (and part of paracorporeal VAD) established in 2010. The first analytical report was published in 2017. The organization running J-MACS was used to be the pharmaceuticals and medical devices agency (PMDA), but has been changed to the council for clinical use of ventricular assist device related academic societies in 2017. Methods Since 2018, we changed the analytical methods as follows: first, we eliminated paracorporeal VAD from the analysis. Second, we included not only primary implantation but bridge to bridge (BTB) implantation of LVAD. Third, we added the analyses of adverse events that were not included in the previous analysis. Results As of Oct 2018, 711 primary LVAD implants and 168 BTB implants were enrolled. Survival rate of primary LVAD was 93% at 360 days and 91% at 720 days, and that of BTB was 86% at 360 days and 82% at 720 days. Conclusion We first reported the results of BTB in the second official report of J-MACS. The prognosis after LVAD implantation has been kept good in Japanese circumstances.

BACKGROUND Patients with advanced heart failure and cardiogenic shock (CS) often require temporary circulatory support (TCS) as a bridge to durable ventricular assist devices (dVADs). We aim to characterize longitudinal outcomes of patients with and without CS. METHODS Between 2013 and 2017, 13,813 adult patients classified as Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profiles 1 to 3 with continuous flow left ventricular assist devices or biventricular assist devices were registered into the International Society for Heart and Lung Transplantation Registry for Mechanically Assisted Circulatory Support. Patients were sub-grouped according to support type (extracorporeal membrane oxygenation [ECMO], intra-aortic balloon pump [IABP], and other TCS). Other TCS included all other surgical and percutaneous TCS devices. Estimated survival was compared based on need for pre-operative TCS and by profile. RESULTS Pre-operative TCS was used in 5,632 (41%) cases. Of these, ECMO was used in 1,138 (20%) cases, IABP in 3,901 (69%) cases, and other TCS in 595 (11%) cases. Patients requiring ECMO had greater needs for biventricular support after dVAD (22% ECMO, 5% IABP, and 7% other TCS; p < 0.001) with longer post-implant intensive care stays (ECMO 24 days, IABP 14 days, and other TCS 12 days; p < 0.001). INTERMACS Profile 1 to 3 patients with pre-implant ECMO had the lowest longitudinal survival (82% at 1 month and 44% at 48 months) compared with IABP (93% at 1 month and 51% at 48 months), other TCS (92% at 1 month and 52% at 48 months), and non-TCS (95% at 1 months and 55 % at 48 months) (p < 0.0001). Propensity score matching analysis of the pre-implant ECMO INTERMACS Profile 1 group when compared with alternative pre-implant TCS strategies had an associated higher hazard impacting early phase survival vs other TCS (hazard ratio, 1.80; p < 0.01) and IABP (hazard ratio, 1.65; p < 0.01). CONCLUSIONS In advanced heart failure with patients with CS, the use of ECMO before dVAD was associated with lower longitudinal survival and increased utilization of biventricular support compared with alternative TCS strategies. Research focused on longitudinal profiling in CS and pre-implant TCS is warranted to further understand these differences.

BACKGROUND Although peak oxygen uptake (pVO2) is a well-established powerful prognostic predictor in heart failure (HF) patients, implementation of cardiopulmonary exercise testing (CPX) is limited by its complex analysis. We aimed to develop a new bivariate predictor obtained without respiratory gas measurement, comparable to pVO2.Methods and Results:We studied 560 consecutive HF patients with ejection fraction (EF)

Hemolysis is closely related with pump thrombosis and thromboembolic events in patients with continuous flow left ventricular assist devices. We retrospectively investigated the impact of early postoperative heparinization on hemolysis in patients with HeartMate II devices. From April 2013 to August 2017, 83 patients (age 45 ± 12 years; 20 females; body surface area 1.6 ± 0.2 m2) underwent HeartMate II implantation. Postoperative heparinization was started when hemostasis was achieved and continued until full warfarinization. Hemolysis was defined in accordance with the Interagency Registry for Mechanically Assisted Circulatory Support definitions. The average support period was 22 ± 14 months. The 6-, 12-, and 24-month freedoms from hemolysis were 72%, 70%, and 67%, respectively. Pump thrombosis developed in five (6%) patients and four (5%) required pump exchanges. Heparin start time was significantly later in patients with hemolysis (43 ± 23 h after implantation) versus those without (29 ± 14 h after implantation; p = 0.01). Receiver operating characteristic analysis determined the cut-off point of heparin start time as 29 h. The patients were divided into the early group (heparin start time 29 h; n = 54). The respective 6-, 12-, and 24-month freedoms from hemolysis for the early group (86%, 86%, and 86%, respectively) were significantly higher than those for the late group (49%, 47%, and 44%, respectively; p = 0.002). Being in the late group was an independent risk factor for hemolysis (hazard ratio 4.09). Early postoperative heparinization (within 29 h after implantation) reduces hemolysis in patients with HeartMate II devices.

Objective This study aimed to compare a novel point-of-care assay that involves a flap endonuclease reaction performed using GTS-7000® to a conventional assay that involves DNA sequencing performed using 3130xl Genetic Analyzers*. Materials and methods This study enrolled 74 patients who underwent heart transplantation at the National Cerebral and Cardiovascular Center between May 2004 and October 2016. Each patient was genotyped as cytochrome P450 (CYP) 3A5*1/*1, -CYP3A5*1/*3, or CYP3A5*3/*3. Quantitative and qualitative comparison between the two assays was carried out. Results Four patients were genotyped as CYP3A5*1/*1, 25 as CYP3A5*1/*3, and 45 as CYP3A5*3/*3. Genotyping results of the point-of-care method were completely consistent with those of the conventional method. The total analysis time of the point-of-care method was shorter than that of the conventional method (~ 1.5 vs. 7.5 h). However, the cost of the point-of-care method was higher than that of the conventional method (~ 21 vs. 17 US$). Conclusion Compared with a laboratory-based assay, the point-of-care assay that utilizes GTS-7000® is accurate and rapid despite being slightly more expensive. Further trials using this assay are warranted.

Purpose Mechanical circulatory support for acute biventricular failure is challenging. Given that durable VAD is available only for LV support as bridge-to-transplantation in Japan, the treatment options for this pathology are limited to extracorporeal biventricular assist device (BiVAD) support first, which can be subsequently upgraded to durable LVAD in cases having recovery of RV function and transplant candidacy. The purpose of this study was to review the outcomes of extracorporeal BiVAD and to explore factors associated with the outcomes. Methods This study enrolled an institutional consecutive series of 39 cases who underwent extracorporeal BiVADs implantation for acute biventricular failure between April 2014 and October 2020. The etiological diagnosis was myocarditis in 27 cases, acute MI in 6 cases, and dilated cardiomyopathy (DCM) in 6 cases. The cases were assigned into the two groups according to the BiVAD support less than 7 days (n=18, Short group) or 7 days or more (n=21, Long group). The Long group consisted of 6 cases of acute MI (100%), 13 cases (48%) of myocarditis, two cases of DCM (33%). Results There was no case who deceased within 7 days after BiVAD implantation. In the Short group, extracorporeal LVAD was weaned-off in 11 cases (61%) or upgraded to durable LVAD in 6 cases after withdrawal of RV support within 7 days. The remaining one case deceased under extracorporeal LVAD. In the Long group, RV support was discontinued in 10 cases in the median support of 60 days (IQR; 24.2-76.8), while two cases were on BiVAD support at October 2020. The remaining nine cases (43%) deceased under BiVAD support in-hospital. Survival and VAD-free survival at 1 year were 79% and 56% in the Short group versus 48% and 20% in the Long group, respectively. Conclusion Outcomes of extracorporeal BiVAD support for acute biventricular failure were dependent on recovery of RV function. Targeting approach for RV function would be warranted for poor biventricular function.