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Objectives: Progression of aortic insufficiency during left-ventricular assist device (LVAD) support is a crucial topic. One treatment option is aortic valvuloplasty (AVP); however, there is controversy regarding its safety and efficacy. We investigated the safety and efficacy of AVP using the coaptation stitch method (Park's stitch) performed for de novo aortic insufficiency. Methods: Between 2013 and 2020, 175 consecutive patients underwent LVAD implantation, of which 7 patients [men, 2 (28.6%); median age, 55 years] underwent late-stage AVP. Two patients underwent AVP within 2 weeks, and the remaining six patients underwent AVP 3, 19, 24, 28, 42, and 49 months, respectively, after LVAD implantation. Results: Preoperatively, the degree of aortic insufficiency was moderate in 6 (85.7%) patients and severe in 1 (14.3%) patient. AVP was technically successful in 6 (85.7%) patients, while one case of failed plasty was subsequently treated with bioprosthetic valve replacement. A 1-year post-AVP right heart catheterization study revealed a median pulmonary artery wedge pressure of 10.0 mmHg. No deaths or heart failure admissions occurred during the follow-up (median, 38.0 months). There was no aortic insufficiency in 2 (28.6%) patients; however, trivial AI was observed in 3 (42.8%) patients, and mild AI was observed in 1 (14.3%) patient 2 years postoperatively. However, at the 3-year follow-up, two patients developed an increase in AI grade from trivial to mild. Conclusions: AVP using Park's stitch was safe. It is critical to carefully observe the aortic valve during AVP surgery to ensure that AVP is appropriate. [ABSTRACT FROM AUTHOR]

Background: Despite the growing popularity of robotically assisted mitral repair, robotically assisted tricuspid repair has not been widely adopted. We assessed the safety and feasibility of robotic tricuspid annuloplasty with continuous sutures for tricuspid regurgitation (TR). Methods and results: We studied consecutive 68 patients (median age, 74 years) with secondary TR who underwent tricuspid annuloplasty using continuous sutures with (n = 61) and without mitral valve repair (n = 7) from 2018 to 2021. Robotic tricuspid annuloplasty consists of continuous sutures with flexible prosthetic band to the tricuspid annulus using two V-Loc barbed sutures (Medtronic Inc., Minneapolis, MN). Concomitant maze procedure was performed in 45 (66%) patients. Robotic tricuspid annuloplasty with continuous sutures was successfully performed. There was no in-hospital or 30-day mortality; 65 patients (96%) did not experience major surgery-related complications. Preoperatively, the TR grade was mild in 20 (29%) patients and mildly higher in 48 (71%). Postoperatively, the TR severity significantly improved, with TR grade mildly higher in 9% at hospital discharge and 7% at 1-year follow-up (p < 0.001). The 1-year and 2-year freedom rates from heart failure were 98% and 95%, respectively. Conclusions: Robotic tricuspid annuloplasty with continuous sutures is safe and feasible alone or concomitant with mitral valve repair. It offered sustained improvement in TR severity and might prevent heart failure readmission. [ABSTRACT FROM AUTHOR]

Background: Chronic postsurgical pain (CPSP) worsens patients' mortality, morbidity, and quality of life. Cardiopulmonary bypass is mandatory for cardiac surgery, but it induces intense inflammation. The presence of inflammation is a crucial part of pain sensitization. An extreme inflammatory response due to cardiopulmonary bypass might cause a high prevalence of CPSP after cardiac surgery. We hypothesized that the prevalence and severity of CPSP are higher in patients after on-pump coronary artery bypass graft (CABG) surgery than in those after off-pump CABG surgery. Methods: This prospective, observational study was performed on a cohort from a randomized trial (on-pump CABG: 81 patients, off-pump CABG: 86 patients). A questionnaire about the severity of surgical wound pain that evaluated pain with the numerical rating scale (NRS) was filled out by the patients. NRS responses for current pain, peak pain in the last 4 weeks, and average pain in the last 4 weeks were evaluated. The main outcomes were the severity of CPSP as evaluated using the NRS and the prevalence of CPSP. CPSP was defined as pain with an NRS score > 0. Differences in severity between groups were analyzed using multivariate ordinal logistic regression models adjusted for age and sex, and differences in prevalence between groups were analyzed using multivariate logistic regression models adjusted for age and sex. Results: The questionnaire return rate was 77.0%. During a median follow-up of 17 years, 26 patients complained of CPSP (on-pump CABG: 20 patients, off-pump CABG: 6 patients). Ordinal logistic regression showed that the NRS response for current pain (odds ratio [OR] 2.34; 95% CI 1.12–4.92; P = 0.024) and the NRS response for peak pain in the last 4 weeks (OR 2.71; 95% CI 1.35–5.42; P = 0.005) were significantly higher in patients who underwent on-pump CABG surgery than in those who underwent off-pump CABG. Logistic regression showed that on-pump CABG surgery was an independent predictor of CPSP (OR 2.59; 95% CI 1.06–6.31; P = 0.036). Conclusions: The prevalence and severity of CPSP are higher in patients with on-pump CABG surgery than in those with off-pump CABG surgery. [ABSTRACT FROM AUTHOR]

Implantation of left ventricular assist device (LVAD) for arrhythmogenic right ventricular (RV) cardiomyopathy is challenging associated with small LV cavity, laterally dislocated LV apex, thin and fragile RV free wall. A 43-year-old male with more than 10 years of medical treatment developed congestive heart failure related to biventricular failure. Durable LVAD was indicated to prevent further deterioration of the RV function, which would be exacerbated by progression of LV dysfunction. To simulate surgery, we printed-out a 3D heart model based on enhanced CT scanning study to identify the optimal coring position in the LV apex, by which the inflow directs the mitral valve. We then found that the mini-cuff of the HeartMate3 should be fixed in the paper-thin RV free wall by the usual cuff-sewing method. In the surgery, after the coring as planned, 5 pairs of interrupted sutures on the medial side were passed from the luminal side of the LV and then to the mini-cuff, and the lateral side of the mini-cuff was fixed with a continuous sutures, not to sew into the RV wall. The surgery was completed without complications with a good hemodynamics. The 3D heart model facilitated this unique method, indicating a usefulness of printed-out heart model for cases with unusual cardiac anatomy, which needs implantation of durable LVAD. [ABSTRACT FROM AUTHOR]

Objective: The Japanese Off-Pump Coronary Revascularization Investigation (JOCRI) study reported a non-significant difference in early outcomes and graft patency between off-pump coronary artery bypass grafting and on-pump coronary artery bypass grafting in 2005. The JOCRIED study aimed to review the long-term outcomes of the JOCRI study participants. Method and results: The JOCRIED study enrolled 123 of the JOCRI study participants completing the clinical follow-up between August 2018 and August 2020; 61 patients in the off-pump group and 62 patients in the on-pump group. The follow-up period was 13.8 ± 2.8 years. The groups were compared regarding mortality, the incidence of major adverse cardiac and cerebrovascular events and repeat revascularisation. The 15-year cumulative survival rate (off-pump vs on-pump, respectively; 77.7% vs 75.3%; p = 0.85), major adverse events-free survival rate (62.5% vs 55.6%; p = 0.27) and repeat revascularisation-free rate (84.8% vs 78.0%; p = 0.16) were not significantly different between the two groups. Revascularisation was the most common major adverse events in the JOCRIED participants. Although percutaneous coronary intervention was performed in 8 patients (13%) in the off-pump group and in 14 patients (23%) in the on-pump group (p = 0.23), no patients underwent redo coronary artery bypass grafting. Conclusions: Off-pump coronary artery bypass grafting provides comparable 15-year outcomes to on-pump coronary artery bypass grafting. [ABSTRACT FROM AUTHOR]

Systemic and cerebral embolisms are serious complications of associated with cardiac myxoma. Embolism risk reportedly depends on the gross and histological morphology. This study is aimed at analyzing the morphologic pattern of excised cardiac myxoma as a high-risk embolic cause. Between 1978 and April 2022, 116 surgical specimens of cardiac myxomas were recorded at the pathology department of our hospital. The tumors were classified into three types based on their macroscopic shapes and external morphology—round-smooth, irregular, and villous—to investigate the embolic complications. Of the 116 specimens, 106 macroscopic images of cardiac myxoma (89% were located in the left atrium) were prepared. Round-smooth types were found in 36 (34.0%) patients, irregular types in 32 (30.2%) patients, and the villous types in 38 (35.8%) patients. Multivariable analysis revealed that a villous external appearance was an independent predictor of embolic events (odds ratio: 8.7; 95% confidence interval: 2.4–42.1; p < 0.001). Villous external appearance of cardiac myxoma was associated with the highest risk of distal embolism. [ABSTRACT FROM AUTHOR]

Background: Chronic postsurgical pain (CPSP) is defined as chronic pain that develops or increases in intensity after a surgical procedure and persists beyond the healing process, defined as at least 3 months postoperatively. However, the rationale behind this time period is weak. Methods: This prospective observational study included a total of 238 consecutive patients who underwent mitral valve repair via thoracotomy. A questionnaire consisting of a numerical rating scale (NRS) to assess the severity of postsurgical pain was mailed to each participant more than 3 months after the operation. The outcomes of interest were current pain, peak pain in the last 4 weeks, and average pain in the last 4 weeks, each assessed using the NRS. The nonlinear associations between the elapsed time after surgery and the intensity of CPSP were evaluated. All statistical analyses were performed with a two-sided significance level of 5%. Results: Two-hundred and ten patients (88.2%) answered the questionnaire. There was a significant nonlinear association between the elapsed time after surgery and each NRS response (all, P < 0.05). The lowest adjusted log odds of current pain, peak pain in the past 4 weeks, and average pain in the past 4 weeks were − 1.49, − 1.13, and − 1.26 at 33, 33, and 33 months postoperatively, respectively. Conclusions: There was a significant U-shaped association between the elapsed time after surgery and intensity of CPSP. The adjusted log odds of each NRS response was lowest at 33 months after cardiac surgery via thoracotomy. [ABSTRACT FROM AUTHOR]

Background: Postprocedural mitral stenosis (MS), or increased transmitral mean pressure gradient (TMPG), is one of the limitations of transcatheter edge-to-edge mitral valve repair using MitraClip (Abbott Vascular Inc., Santa Clara, USA); however, the usefulness of three-dimensional transesophageal echocardiography (3D-TEE) for predicting postprocedural MS in functional mitral regurgitation (MR) has not been fully elucidated. Methods: Eighty-two consecutive functional MR patients who underwent transcatheter mitral valve repair using MitraClip were retrospectively studied. Postprocedural MS was defined as TMPG ≥ 5 mmHg by echocardiography. Results: Ten patients had postprocedural MS, and 3D-TEE showed that patients with postprocedural MS had smaller preprocedural mitral valve orifice area (MVOA), anteroposterior and mediolateral diameter, leaflet area, and annulus area. Receiver operating characteristic analysis showed that leaflet area (area under the curve (AUC) 0.829), annulus area (AUC 0.813), anteroposterior diameter (AUC 0.797) and mediolateral diameter (AUC 0.803) evaluated using 3D-TEE were predictors of postprocedural MS, and their predictive abilities were higher than those of preprocedural MVOA (AUC 0.756) and preprocedural TMPG (AUC 0.716). Adding leaflet area to TMPG and MVOA resulted in higher C-statistics for predicting postprocedural MS (from 0.716 to 0.845 and from 0.756 to 0.853, respectively). Conclusions: In functional MR patients treated with MitraClip, leaflet area and annulus area evaluated using 3D-TEE had high predictive values for postprocedural MS, and their predictive abilities were higher than those of preprocedural TMPG or MVOA. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

A bridging strategy from extracorporeal life support (ECLS) is effective in salvage and a bridge to recovery or to a durable left ventricular assist device (LVAD) for acute refractory heart failure. However, the correlation of this strategy with adverse events after durable LVAD implantation has not been fully investigated. This study enrolled 158 consecutive patients who had either the HeartMate II or HeartMate 3 and were implanted for bridge-to-transplantation. These devices were implanted as the primary mechanical support device in 115 patients, whereas the remaining 43 underwent LVAD implantation as the bridge from central ECLS. The primary study endpoint was all-cause mortality and cerebrovascular accidents (CVAs) after durable LVAD implantation, and the secondary endpoints were adverse events. Overall survival was not significantly different between the two groups. In contrast, the probability of CVAs was significantly greater in the bridge group than in the primary group (probability of CVAs, P = 0.002; log-rank test). In Cox multivariate logistic regression analysis, a bridge from central ECLS was an independent predictive factor of CVAs (hazard ratio 4.27, 95% confidence interval 1.43–12.8; P = 0.0095). Patients who are bridged from central ECLS are more frequently complicated by CVAs compared with those who undergo primary implantation of a durable LVAD, but survival is not significantly different between the two groups. A bridge from central ECLS is an independent predictive factor of CVAs post-implantation of an LVAD. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to elucidate the mid-term outcomes and risk factors for recurrent mitral regurgitation after mitral valve (MV) surgery for atrial functional mitral regurgitation (AFMR). Methods and results: We retrospectively analyzed data of 50 consecutive patients (median age 74 years; 29 men) who underwent mitral valve surgery for AFMR between January 2001 and January 2019. Mean atrial fibrillation duration was 12 years. During the follow-up period of 4.6 ± 4.4 years, 5 cardiac-related deaths were identified. Five- and 10-year freedom from cardiac-related death rate for all patients was 88.4% and 78.6%. In total, 42 patients underwent MV repair with mitral annuloplasty and 8 underwent MV replacement. Five- and 10-year freedom from cardiac-related death rate in patients who underwent MV repair was 93.1% and 82.7%, which was better than MV replacement (log rank p = 0.04). During the follow-up period, MR recurrence rate was 16.8% at 5 and 10 years for the patients who underwent MV repair. Univariate analysis showed that partial band annuloplasty and preoperative elevated left ventricular end-systolic volume index were risk factors for recurrent MR after MV repair. Multivariate analysis identified partial band annuloplasty as the independent predictor for recurrent MR during long-term follow-up after MV repair for AFMR. Conclusion: Patients who underwent MV repair for AFMR could have an acceptable mid-term outcome. However, MVR might not improve the mid-term outcome in patients with AFMR. The use of partial bands for mitral annuloplasty would not be recommended in terms of recurrent MR mid-term. [ABSTRACT FROM AUTHOR]

Objective: Because the presence of immunocompetent cells in the myocardium is associated with the pathological stage and/or myocardial viability, we explored relationships between functional recovery after left ventricular assist device implantation and the distribution of immunocompetent cells in non-ischaemic dilated cardiomyopathy patients. Methods: We reviewed 50 consecutive dilated cardiomyopathy patients implanted with HeartMate II at our institute between April 2013 and December 2018 who were treated with optimal medical therapy during left ventricular assist device support. Patients were stratified by improvement of the left ventricular ejection fraction at 6 months after implantation: ≥ 10% increase (Gr ≥ 10%), 5–10% (Gr 5–10%), and ≤ 5% (Gr ≤ 5%). T cells and macrophages were evaluated in the apical myocardium after left ventricular assist device implantation. Results: During left ventricular assist device support, 12 patients underwent heart transplantation and 2 patients died. Four patients with Gr ≤ 5% were readmitted because of congestive heart failure, but none with Gr ≥ 10%. Macrophages and T cells in the left ventricular myocardium with Gr ≥ 10% were significantly more present compared to those in other groups. Conclusions: The distribution of immunocompetent cells in the left ventricular myocardium might predict myocardial viability of this pathology after implantation. [ABSTRACT FROM AUTHOR]

Objective: Constrictive pericarditis (CP) is a rare disease, and the diagnosis and surgical treatment of CP remain challenging. The aim of this study was to evaluate our Japanese single-center experience with isolated pericardiectomy for CP to elucidate the factors associated with improved outcomes. Methods: Over a 20-year period, 44 consecutive patients underwent isolated pericardiectomy at our institution. The cause of CP was: idiopathic (59%), postsurgical (32%), tuberculosis (7%), and postradiation (2%) of the patients. All patients were diagnosed with CP using multiple modalities, including echocardiography, cardiac catheterization, computed tomography, or magnetic resonance imaging (MRI). Median sternotomy was performed in 42 (95%) patients. Twenty-eight (68%) patients underwent radical pericardiectomy. Results: The postoperative diagnosis in all patients was CP. Among the multiple modalities, cardiac MRI had the greatest diagnostic sensitivity (97.2%). There were no operative or hospital deaths; late mortality occurred in seven (15.9%) patients in the series. Multivariable analysis showed that preoperative low LVEF was a risk factor for long-term mortality. Seven patients were readmitted for heart failure postoperatively. Multivariable analysis showed incomplete pericardiectomy and use of a preoperative inotrope were risk factors for readmission for heart failure. Conclusions: The diagnosis using multimodality imaging for CP was effective in our institution and tagged cine MRI had the greatest sensitivity in diagnosing CP. Preoperative condition, including preoperative low LVEF or inotrope use, was correlated with long-term outcome after pericardiectomy. Pericardiectomy should be performed early and as radically as possible to prevent recurrent heart failure. [ABSTRACT FROM AUTHOR]

Purpose: A coronary artery aneurysm (CAA) can result in critical cardiac events such as thromboembolic complications or rupture. A saccular CAA located in the left main trunk (LMT) is the most critical form of this pathology and its surgical repair is challenging. We conducted this single-center study to review the surgical outcomes of patients with a saccular CAA in the LMT. Methods: Between May, 2012 and June, 2020, five patients with a saccular CAA in the LMT underwent surgery at our center. The median age at operation was 66.5 (59.7–69) years and the median diameter of the CAA was 13.0 mm (IQR 11–14 mm). Results: The CAA was fully excluded by patch closure of the LMT orifice and direct closure of the distal LMT, supplemented by coronary artery bypass grafting with the exclusive use of arterial conduits. There was no in-hospital mortality, although one patient suffered graft spasm-related myocardial infarction with complete recovery. Post-operative angiography showed a fully excluded LMT in all patients. There was no mortality or adverse cardiac events during follow-up. Conclusions: Our surgical policy for CAA in the LMT is feasible and safe; however, coronary blood flow is dependent on reliable bypasses. [ABSTRACT FROM AUTHOR]

Objectives: A new stented bovine pericardial valve (Avalus™) has been proven safe and effective with good hemodynamic performance in Western populations. However, its use in Japanese patients is poorly understood. We retrospectively compared the feasibility, safety, and valve haemodynamics between the Avalus™ and Magna™ valves in patients who underwent surgical aortic valve replacement (SAVR). Methods: This study included 87 patients receiving an Avalus™ valve and 387 receiving a Magna™ valve. We evaluated adverse events, outcomes, and valve haemodynamics within 1 year postoperatively. There were no significant differences in any surgical risk scores. Results: No in-hospital mortality occurred in the Avalus™ group, but two mortality events occurred in the Magna™ group. No pacemaker implantation for complete atrioventricular block was required in the Avalus™ group. There was no significant difference in in-hospital or clinical outcomes between the two groups until 1 year postoperatively. Left ventricular mass index reduction appeared to predominate in the Avalus™ over Magna™ group. There was no significant difference in the mean pressure gradient or effective orifice area of each valve size at 1 week or 1 year between the two groups, apart from the mean pressure gradient of the 23-mm valve at 1 week. Three patients (3.4%) in the Avalus™ group and 39 (10.8%) in the Magna™ group (p = 0.12) had severe patient–prosthesis mismatch at 1 week postoperatively. Conclusions: The new Avalus™ stented aortic valve bioprosthesis was associated with good in-hospital outcomes and good valve functionality post-SAVR in Japanese patients. [ABSTRACT FROM AUTHOR]

Objective: The effect of patient sex in continuous-flow ventricular assist device (c-VAD) therapy has not been well described. We investigated sex-specific differences in clinical outcomes related to c-VAD therapy for Japanese patients. Methods: We retrospectively analyzed 153 patients, including 41 (27%) female patients who underwent c-VAD implantation over the last 13 years in our institution for a mean follow-up of 766 ± 446 days. Clinical outcomes were compared between male and female patients Results: There was no significant difference in mortality, cerebral vascular accidents, the severity of heart failure, or driveline infection in patients who underwent c-VAD implantation, regardless of sex. While male patients tended to have more bleeding at the time of surgery, female patients had significantly higher rates of non-surgical bleeding during subsequent c-VAD therapy, mainly from gynecological origins. Conclusions: Female patients treated with c-VAD had a significantly higher incidence of non-surgical bleeding events. Careful attention to gynecological complications and sex-specific care is required in female patients with c-VAD. [ABSTRACT FROM AUTHOR]

Aortic insufficiency (AI) is an important adverse event in patients with continuous-flow (CF) left ventricular assist device (LVAD) support. AI is often progressive, resulting in elevated 2-year morbidity and mortality. The effectiveness of echocardiographic ramp studies in patients with AI has been unclear. Here, we describe a patient with a CF-LVAD implant who underwent aortic valve replacement (AVR), following assessment of AI using a hemodynamic ramp test with simultaneous echocardiography and right heart catheterization (RHC). The patient was a 21-year-old man with cardiogenic shock due to acute myocarditis, who underwent HeartWare CF-LVAD (HVAD) implantation. Heart failure persisted despite increased doses of diuretics and inotrope, as well as an increased HVAD pump rate. HVAD monitoring revealed a correlation between increased HVAD pump rate and flow at each speed step. A hemodynamic ramp test with simultaneous transthoracic echocardiography and RHC revealed a significant discrepancy between HVAD pump flow and cardiac output (CO) at each speed step; moreover, pulmonary capillary wedge pressure remained high. Therefore, the patient underwent AVR. Subsequently, his low CO symptoms disappeared and inotropes were successfully discontinued. A postoperative hemodynamic ramp test revealed that AVR had successfully closed the loop of blood flow and reduced the discrepancy between HVAD pump flow and CO, thereby increasing CO. The patient was then discharged uneventfully. In conclusion, a hemodynamic ramp test with simultaneous echocardiography and RHC was useful for the evaluation of the causal relationship between AI and low CO, and for selection of surgical treatment for AI in a patient with CF-LVAD. [ABSTRACT FROM AUTHOR]

Atrial tachycardia (AT) and atrial fibrillation (AF) commonly occur after cardiac surgeries (CSs). This study investigated the mechanisms and long-term outcomes of AT and AF ablation after various Maze procedures, particularly whether atrial tachyarrhythmias after the Maze procedure occur due to gaps in the Maze lines. We analyzed 37 consecutive cases with atrial tachyarrhythmias after the Maze procedures and concomitant CSs between 2007 and 2019. Fifty-nine atrial tachyarrhythmias were induced in 37 consecutive cases, and 49 of those atrial tachyarrhythmias were mappable ATs. Forty ATs were related to the Maze procedures in the 49 mappable ATs (81.6%). All 37 consecutive cases had residual electrical conductions (gaps) in the Maze lines (88 gaps; 2.4 ± 1.2 gaps/patient). Forty of 88 gaps (45.5%) were associated with gap-related ATs. The common ATs in this study were 1. peri-mitral atrial flutter due to gaps at pulmonary vein isolation (PVI) line to mitral valve annulus (MVA) (20 cases), and 2. peri-tricuspid atrial flutter due to gaps at right atrial incision to the tricuspid valve annulus (TVA) (10 cases). Forty-seven of 49 ATs (95.9%) were successfully ablated at the first session, and there were no complications. The mean follow-up period after ablation was 3.6 ± 3.2 (median, 2.1; interquartile range, 0.89–6.84) years. The Kaplan–Meier analysis of freedom from recurrent atrial tachyarrhythmias after Maze procedure was 82.7% at 1-year follow-up and 75.5% at 4-year follow-up after a single procedure. Reentry was the main mechanism of ATs after Maze procedures and concomitant CSs, and ATs were largely related to the gaps on the Maze lines between the PVI line and the MVA or those on the lines between right atrial incision to the TVA. Long-term follow-up data suggest that catheter ablation of atrial tachyarrhythmias after various Maze procedures is effective and safe. [ABSTRACT FROM AUTHOR]

Background: Ischemic papillary muscle rupture (PMR) is a catastrophic complication following acute myocardial infarction (AMI). We evaluated early outcomes of PMR by using data from the Japan Cardiovascular Surgery Database, a nationwide Japanese registry. Methods: We retrospectively analyzed data from 196 patients diagnosed with PMR following AMI in Japan between January 2014 and December 2017. Risk factors for operative mortality and severe complications following mitral valve surgery were analyzed. Results: The 30-day and hospital mortality rates were 20% and 26%, respectively. Chronic hemodialysis, abrupt rupture after AMI, resuscitation before surgery, and preoperative venoarterial extracorporeal membrane oxygenation were associated with mortality. Mitral valve replacement was chosen mainly (90%) for surgical correction of mitral regurgitation in these patients. There was no significant difference in short-term outcomes between mitral valve replacement versus mitral valve repair, despite non-matched characteristics in background between the treatment groups. Concomitant coronary artery bypass grafting had no impact on short-term outcomes. Conclusions: Information derived from the nationwide database of patients with AMI-associated PMR show that PMR is a rare condition in the modern era. However, PMR is a severe disease with a mortality rate as high as 26%. The severity of the condition is associated with the risk for poor outcomes. [ABSTRACT FROM AUTHOR]

Purpose: To date, clinical data on real-world treatment practices in Japanese patients with atrial fibrillation (AF) after bioprosthetic valve (BPV) replacement are needed. We conducted a large-scale, prospective, multicenter study to understand the actual usage of antithrombotic therapy and the incidence of thromboembolic and bleeding events in these patients, and to eliminate the clinical data gap between Japan and Western countries. Methods: This was an observational study, in patients who had undergone BPV replacement and had a confirmed diagnosis of AF, with no mandated interventions. We report the baseline demographic and clinical data for the 899 evaluable patients at the end of the enrollment period. Results: Overall, 45.7% of patients were male; the mean age was 80.3 years; AF was paroxysmal, persistent, or permanent in 36.9%, 34.6%, and 28.5% of patients, respectively. Mean risk scores for stroke and bleeding were 2.5 (CHADS2), 4.1 (CHA2DS2-VASc), and 2.5 (HAS-BLED). Many patients (76.2%) had comorbid hypertension and 54.8% had heart failure. Most BPVs (65.5%) were positioned in the aortic valve. Warfarin-based therapy, direct oral anticoagulant (DOAC)-based therapy, and antiplatelet therapy (without warfarin and DOAC) were administered to 55.0%, 29.3%, and 9.7% of patients, respectively. Conclusion: Patients enrolled into this study are typical of the wider Japanese AF/BPV population in terms of age and clinical history. Future data accruing from the observational period will contribute to future treatment recommendations and guide therapeutic decisions in patients with BPV and AF. Trial registration: ClinicalTrials.gov Identifier: UMIN000034485 [ABSTRACT FROM AUTHOR]

Background: The high surgical risk in redo cardiac surgery is largely attributed to adhesions around the epicardium and the great vessels. BAX602 is an adhesion prevention reagent composed of two synthetic polyethylene glycols. Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery. The present study aims to evaluate the safety and effectiveness of BAX602 spray in patients undergoing extracorporeal ventricular assist device implantation surgery to treat refractory congestive heart failure. Methods and Design: This investigator-initiated, multicenter, pivotal, two-arm, open-label, randomized trial will include a total of 30 patients. The primary outcome measure is the severity of adhesions, which will be evaluated during re-sternotomy surgery performed 2–12 weeks after the primary extracorporeal ventricular assist device implantation surgery. The adhesion severity will be evaluated at five predefined sites using a four-grade adhesion evaluation score (0 = no adhesion; 1 = filmy and avascular adhesion; 2 = dense/vascular adhesion; 3 = cohesive adhesion). This measure will be summarized in two ways to evaluate the effect of BAX602: (1) the total score of the severity of adhesions at all five sites (ranging from 0 to 15), and (2) the total number of sites with dense/vascular or cohesive adhesions (ranging from 0 to 5). Ethics and Dissemination: The study findings will be disseminated at regional, national, and international conferences and through peer-reviewed scientific journals. Trial Registration: The trial was registered in the UMIN Clinical Trials Registry (UMIN-CTR: UMIN000038998) on 6 January 2020. [ABSTRACT FROM AUTHOR]

Objective: Robotically assisted mitral valve repair was approved for use in Japan in April 2018. The study objective was to assess the safety and clinical outcomes of robotic mitral valve surgery in the first 100 cases performed in our center. Methods: We reviewed the first 100 patients who underwent robotic primary mitral valve repair, including concomitant procedures, from April 2018 to August 2019. The cause of mitral valve disease was degenerative (n = 94), endocarditis (n = 2), functional (n = 2), and other (n = 2). Results: There was no in-hospital or 30-day mortality. Mitral valve repair was completed in all patients. Only one patient required conversion to full sternotomy due to left ventricular apex bleeding. In echocardiography performed before hospital discharge, the mitral regurgitation was graded as none or trivial in 94 patients (94%) and mild in 4 (4%). Only two patients required surgical re-intervention due to postoperative hemolysis with moderate mitral regurgitation. For patients who underwent the mitral valve procedure alone, the median times of the total operation, cardiopulmonary bypass, aortic clamping, and console usage were 185, 112, 71, and 60 min, respectively. The learning curve showed that the operation time decreased slightly during the first ten cases and then plateaued at a mean of approximately 180 min. Conclusions: Robotically assisted mitral valve repair was feasible, safe, and therapeutically effective in the first 100 cases, with a minimal learning curve. The robotically assisted approach provides a high-quality surgical view and tremorless suture/cut handling, which will contribute to further development of minimally invasive mitral valve surgery. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 = 29), and the late 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. [ABSTRACT FROM AUTHOR]

Purpose: To explore the actual status of chemotherapy-induced nausea and vomiting (CINV) through a multicenter prospective cohort study. Methods: Patients with breast cancer treated with moderately emetogenic (MEC) or highly emetogenic (HEC) chemotherapy were eligible. A 7-day diary was provided for all patients. Acute and delayed CINV were defined as nausea and vomiting that developed ≤ 24 or > 24 h after the start of chemotherapy, respectively. The severity of nausea was evaluated with a visual analog scale (VAS). We also assessed the accuracy of estimations of CINV by medical staff. Results: In total, 426 patients were included; 352 patients (82.6%) received HEC, and 74 (17.3%) received MEC. In the acute phase, 44.9% of patients receiving HEC and 5.4% receiving MEC experienced nausea, and 12.8% receiving HEC and none receiving MEC experienced vomiting. More patients experienced nausea in both groups and vomiting in MEC during the delayed phase (nausea: 59.4% in HEC and 44.6% in MEC group; vomiting: 11.1% in HEC; and 13.5% in MEC group) than during the acute phase. Estimations of CINV by medical staff were not accurate, with a kappa coefficient of 0.10 and 0.08 for acute nausea and vomiting and 0.02 and 0.01 for delayed. The VAS scores showed that in the HEC group, the degree of nausea was worst on the first day. Conclusions: The degree of nausea was worst in the acute phase, although delayed nausea was more in proportion in HEC. Estimation by medical staff is not accurate. [ABSTRACT FROM AUTHOR]

Objective: The mitral valve-in-valve procedure has been performed in the world. However, the early clinical outcomes in Japan remain unclear. Hence, we investigated the feasibility, safety, and efficacy in high-risk Japanese patients. Methods: In May 2017, we launched the present clinical study of the mitral valve-in-valve procedure (MITRAL VIV study). The study enrolled four patients (three women; age range 69–85 years) with severe mitral regurgitation due to a degenerated mitral bioprosthesis. The median Society of Thoracic Surgeons score was 8.8 (range 8.4–9.8)%. Results: In all patients, the mitral valve-in-valve procedure was successfully performed via a transapical approach at the initial attempt. The median grade of mitral insufficiency improved from grade 4 (range 3–4) to grade 1 (range 0–1) at days 7 and 30. The mean mitral pressure gradient of the median value changed from 7.0 (range 5.0–8.0) mmHg to 5.0 (range 5.0–9.5) mmHg at 7 days and 6.2 (range 4.0–11.0) mmHg at 30 days. The median New York Heart Association functional class improved from 2 (range 2–3) to 1 (range 1–3) at day 7 and to 1 (range 1–2) at day 30. We performed a bit deep implantation intentionally to avoid left ventricular outflow tract obstruction in one patient with a small aorto-mitral-annular angle. Neither mortality nor severe complications were observed at the last follow-up (range 207–513 days). Conclusions: In our experience, the safe mitral valve-in-valve procedure was feasible with cautious procedures. [ABSTRACT FROM AUTHOR]

Objective: The valve-in-valve procedure, in which a transcatheter heart valve (THV) is implanted into a degenerated bioprosthetic valve, is standardized for high-risk patients. However, this procedure is challenging in Japanese patients who have a small aortic annulus. We investigated the feasibility, safety, and therapeutic efficacy of the valve-in-valve procedure involving a degenerated stented bioprosthesis, stentless bioprosthesis, or THV. Methods: We performed a single-center, non-comparative study of the aortic valve-in-valve procedure (AORTIC VIV study). Beginning in October 2016, the aortic valve-in-valve procedure was performed in seven patients with a stented bioprosthesis, in three patients with a stentless bioprosthesis, and in one patient with a THV. Results: No 30-day post-procedure mortality or severe morbidities occurred. The mean echocardiographic gradient in the aortic position improved from 41 (38–48) to 17 (11–22) mmHg at 30 days (p = 0.01). No paravalvular or mild and more transvalvular leaks were detected. The New York Heart Association functional class improved from 2 (2–2.5) to 1 (1–1) at 30 days postoperatively (p = 0.01). Although the procedure failed in two patients with an implanted stentless bioprosthesis, the third patient with a stentless bioprosthesis and the one patient with a degenerated THV successfully underwent the valve-in-valve procedure. Conclusions: Feasibility, safety, and potential efficacy of the aortic valve-in-valve procedure were confirmed in selected Japanese patients with a degenerated aortic bioprosthesis. The valve-in-valve procedure for stentless bioprostheses was technically challenging. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: The standard treatment of prosthetic paravalvular leakage (PVL) accompanied by heart failure or hemolytic anemia is repeat open surgery. Although favorable outcomes for transcatheter prosthetic PVL closure in patients with a high surgical risk for repeat open surgery have been reported, procedural feasibility has not been examined in Japan. Methods: From March 2015 to November 2015, transcatheter PVL closure in mitral position was performed in four patients (age range 41–78, three females) with high surgical risk due to history of repeated surgeries, chest radiation and reconstruction of the mitral annulus after debridement of abscess owing to infective endocarditis. All procedures were performed via a transapical approach under general anesthesia. Results: Of four patients, the indications for PVL closure of two patients were heart failure, and those of the others were hemolytic anemia. There were no major complications, mortalities, or prolonged intensive care unit or hospital stays. Technical success was achieved in two patients. Moderate paravalvular regurgitation persisted in one patient, although regurgitation reduction of one grade was obtained. In one patient, occluder devices were not deployed because the wire could not cross the defect. Improvement in New York Heart Association functional class compared with that at baseline was observed in two patients. Conclusions: The safety and acute technical success rates of transcatheter mitral PVL closure via a transapical approach were confirmed in Japanese patients. In Japan, transcatheter PVL closure may be an alternative option for patients with PVL who have a high surgical risk. [ABSTRACT FROM AUTHOR]

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 < 0.02). The numbers of driveline infection events per patient-year were 0.16 in patients with driveline angle more than 42°, and 0.04 in patients with driveline angle less than 41°. Multivariate analysis demonstrated that driveline angle more than 42° was an independent risk factor for driveline infection (hazard ratio 4.71). Driveline angle more than 42° is an independent risk factor for driveline infection in patients with HeartMate II. Externalization of the driveline toward the horizontal direction is important to prevent driveline infection with HeartMate II. [ABSTRACT FROM AUTHOR]

Lower limb ischemia with an occlusive cannula is a potential complication of minimally invasive cardiac surgery (MICS). We evaluated intraoperative local oxygen supply-demand balance by monitoring regional saturation of oxygen (rSO2) using near-infrared spectroscopy (NIRS), and analyzed the correlation between cannula size and fluctuation range of rSO2. Fifty-four patients undergoing MICS surgery using femoral artery cannulation from April 2015 to August 2016 were enrolled. The rSO2 of both the cannulated and uncannulated lower limbs were measured using NIRS. The association between the decline of rSO2 from baseline (delta-rSO2) and the ratio of the cannula diameter to the femoral artery diameter (Cd/FAd) was analyzed. Of the 54 patients, 16 (30%) (Group 1) showed values over 0.65 for Cd/FAd, and the remaining 38 (70%) (Group 2) showed values under 0.65. No patient developed postoperative lower limb ischemia. No patient was treated with an ipsilateral distal perfusion cannula. There were significant differences between Group 1 and Group 2 in the decrease of rSO2 at the point of cannulation on the cannulated limb. In the lower limb on the cannulated side, delta-rSO2 showed a significant decrease in Group 1 compared to Group 2 (Group 1 vs Group 2: 19.9 vs 11.0%; p < 0.001). Delta-rSO2 was significantly correlated with body surface aera (BSA), but not with gender or age. Decreasing rSO2 correlates with the Cd/FAd index. Low BSA, Cd/Fad > 0.65 is considered as the risk factor for decline of rSO2 in cannulated limb in MICS. [ABSTRACT FROM AUTHOR]

Purpose: The methods (IHC/FISH) typically used to assess ER, PR, HER2, and Ki67 in FFPE specimens from breast cancer patients are difficult to set up, perform, and standardize for use in low and middle-income countries. Use of an automated diagnostic platform (GeneXpert®) and assay (Xpert® Breast Cancer STRAT4) that employs RT-qPCR to quantitate ESR1, PGR, ERBB2, and MKi67 mRNAs from formalin-fixed, paraffin-embedded (FFPE) tissues facilitates analyses in less than 3 h. This study compares breast cancer biomarker analyses using an RT-qPCR-based platform with analyses using standard IHC and FISH for assessment of the same biomarkers.Methods: FFPE tissue sections from 523 patients were sent to a College of American Pathologists-certified central reference laboratory to evaluate concordance between IHC/FISH and STRAT4 using the laboratory’s standard of care methods. A subset of 155 FFPE specimens was tested for concordance with STRAT4 using different IHC antibodies and scoring methods.Results: Concordance between STRAT4 and IHC was 97.8% for ESR1, 90.4% for PGR, 93.3% for ERBB2 (IHC/FISH for HER2), and 78.6% for MKi67. Receiver operating characteristic curve (ROC) area under the curve (AUC) values of 0.99, 0.95, 0.99, and 0.85 were generated for ESR1, PGR, ERBB2, and MKi67, respectively. Minor variabilities were observed depending on the IHC antibody comparator used.Conclusion: Evaluation of breast cancer biomarker status by STRAT4 was highly concordant with central IHC/FISH in this blinded, retrospectively analyzed collection of samples. STRAT4 may provide a means to cost-effectively generate standardized diagnostic results for breast cancer patients in low- and middle-income countries. [ABSTRACT FROM AUTHOR]

Background: The management of heart failure patients presenting in a moribund state remains challenging, despite significant advances in the field of ventricular assist systems. Bridge to decision involves using temporary devices to stabilize the hemodynamic state of such patients while further assessment is performed and a decision can be made regarding patient management. The purpose of this study (NCVC-BTD_01, National Cerebral and Cardiovascular Center-Bridge to Dicision_01) is to assess the safety and effectiveness of the newly developed extracorporeal continuous-flow ventricular assist system employing a disposable centrifugal pump with a hydrodynamically levitated bearing (BR16010) use as a bridge-to-decision therapy for patients with severe heart failure or refractory cardiogenic shock.Method/Design: NCVC-BTD_01 is a single-center, single-arm, open-label, exploratory, medical device, investigator-initiated clinical study. It is conducted at the National Cerebral and Cardiovascular Center in Japan. A total of nine patients will be enrolled in the study. The study was planned using Simon’s minimax two-stage phase design. The primary endpoint is a composite of survival free of device-related serious adverse events and complications during device support. For left ventricular assistance, withdrawal of a trial device due to cardiac function recovery or exchange to other ventricular assist devices (VADs) for the purpose of bridge to transplantation (BTT) during 30 days after implantation will be considered study successes. For right ventricular assistance, withdrawal of tal device due to right ventricular function recovery within 30 days after implantation will be considered a study success. Secondary objectives include changes in brain natriuretic peptide levels (7 days after implantation of a trial device and the day of withdrawal of a trial device), period of mechanical ventricular support, changes in left ventricular ejection fraction (7 days after implantation of a trial device and the day of withdrawal of a trial device), and changes in left ventricular diastolic dimension (7 days after implantation of a trial device and the day of withdrawal of a trial device).Ethics and Dissemination: We will disseminate the findings through regional, national, and international conferences and through peer-reviewed journals.Trial Registration: UMIN Clinical Trials Registry (UMIN-CTR; R000033243) registered on 8 September 2017. [ABSTRACT FROM AUTHOR]

Case 1: 17-year-old boy developed severe stenosis at the proximal site of the coronary aneurysm in the left anterior descending artery (LAD). Case 2: 16-year-old boy developed severe stenosis at the proximal site of the coronary aneurysm in the LAD. Case 3: 30-year-old woman developed severe stenosis of the distal portion of the coronary aneurysm in the LAD. Minimally invasive direct coronary artery bypass (MIDCAB) with robot-assisted left internal thoracic artery harvest was successfully performed without cardiopulmonary bypass in these three young patients with Kawasaki disease. This is the first case report of robot-assisted MIDCAB for Kawasaki disease. [ABSTRACT FROM AUTHOR]

Although mitral regurgitation (MR) is prevalent in patients with end-stage heart failure, the impact of mitral valve (MV) surgery on outcomes after left ventricular assist device (LVAD) implantation and morphologic changes of MV remains unclear. We retrospectively reviewed 74 patients who underwent LVAD implantation as a bridge to transplant. Of these, 11 (15%) underwent MV repair concomitant with or prior to LVAD implantation, while 27 patients with preoperative significant (moderate or greater) MR did not undergo concomitant MV surgery. The mean interval between LVAD implantation and the last echocardiographic examination was 913 days. Irrespective of MV surgery, significant LV reverse remodeling including decreased LV and left atrial dimension and improved MR severity was observed in all patients except for patients with prior MV surgery. Histopathological examination of explanted hearts removed at heart transplantation (n = 69) or autopsy (n = 5) revealed that the MV annulus was still dilated (mean perimeter 11.7 cm) in the patients with preoperative significant MR and no concomitant MV surgery. Concomitant MV surgery at the time of LVAD implantation for significant MR might not be always necessary for bridge to transplant or destination therapy cases. However, it might be required in patients having potential for cardiac recovery or patients with severe pulmonary hypertension and depressed right ventricle. [ABSTRACT FROM AUTHOR]

Percutaneous veno-arterial extracorporeal membrane oxygenation (VA-ECMO) provides emergency circulatory support for cardiogenic shock patients and is used as a bridge to a left ventricular assist device (LVAD). The purpose of this study was to determine risk factors for LVAD implantation in patients who required percutaneous VA-ECMO as a bridge to long-term LVAD. We retrospectively investigated 32 consecutive LVAD patients who required percutaneous VA-ECMO as a bridge to long-term LVAD. Twenty-nine patients (91%) were intubated, and their serum creatinine and total bilirubin levels before LVAD implantation were 2.1 ± 2.0 and 3.7 ± 3.7 mg/dl, respectively. Patients were supported by LVAD for 495 ± 393 days, during which 15 died, 6 recovered native cardiac functions and LVAD was explanted, and 11 underwent heart transplantation. Multivariate logistic regression analysis revealed that a preoperative left ventricular end-diastolic diameter (LVDd) ≤54 mm was a significant predictor of 90-day mortality after LVAD implantation (OR 13.64; 95% CI 1.081–172.0; p = 0.0433) and freedom from death during LVAD support was significantly worse in patients with an LVDd ≤54 mm. Furthermore, preoperative LVDd was positively correlated with postoperative right ventricular stroke work index (r = 0.739, p < 0.0001) and patients with an LVDd ≤54 mm had significantly worse postoperative right ventricular, renal, and hepatic functions. We demonstrated that percutaneous VA-ECMO could be utilized as a bridge to long-term LVAD in selected patients. Our results suggest that preoperative LVDd is a useful predictor of mortality and right ventricular function after LVAD implantation in patients requiring VA-ECMO, in whom assessment of right ventricular function is challenging. [ABSTRACT FROM AUTHOR]

A 49-year-old man with ischemic cardiomyopathy and tricuspid regurgitation underwent a DuraHeart implantation and tricuspid annuloplasty for bridge-to-heart transplantation. On postoperative day 393, the magnetic levitation system suddenly broke down, and the pump system went into hydrodynamic bearing rotation (HD) mode without causing relevant symptoms. The controller was exchanged with one that adapted to the HD mode. No significant hemodynamic changes or indications of hemolysis were observed. On postoperative day 982, the pump temporarily stopped nine times. The patient refused pump exchange despite our strong recommendation for it. After 1283 days of DuraHeart support (889 days in HD mode) without hemolysis or neurologic events, he underwent heart transplantation. The DuraHeart manufacturer's analysis revealed much damage to the insulation and fatigue fractures of the conductors, which had resulted in temporary cessation of function and failure of the magnetic levitation system. This was a rare case of long-term support under the DuraHeart HD mode. [ABSTRACT FROM AUTHOR]

Various strategies using a ventricular assist device (VAD) are applied to rescue Interagency Registry for Mechanically Assisted Circulatory Support profile 1 (Profile-1) patients. However, the optimal use of VAD in Profile-1 patients has not been completely elucidated. We retrospectively reviewed 23 Profile-1 patients [mean age 36.9 ± 16.6 years, 14 males; 11 with non-ischemic cardiomyopathy (NICM), 9 with fulminant myocarditis (FM), 2 with ischemic cardiomyopathy (ICM), and 1 with peripartum cardiomyopathy (PPCM); 18 with pre-operative percutaneous extracorporeal membrane oxygenation (p-ECMO) support] who underwent VAD implantation from 2011 to 2015 at our institution. Nine initially received left VAD (LVAD) alone (NICM in 9, ICM in 2 with ICM, and FM in 1), one with NICM received biventricular VAD (BiVAD; n = 1), and 10 received LVAD combined with right ventricular support using an ECMO circuit (BiVAD-ECMO) (FM in 8, NICM in 1, and PPCM in 1). Paracorporeal VAD was used in all patients. ECMO was used for the patients with severe pulmonary edema, inflammation, anemia, and thrombopenia. The BiVAD patient died 1.4 months after VAD implantation. The overall survival was comparable between patients with BiVAD-ECMO and LVAD (2-year survival, 80.0 and 75.0%, respectively). Three VAD strategies were initially applied in Profile-1 patients. Among them, the BiVAD-ECMO strategy is a promising therapeutic option to rescue Profile-1 patients with multiple organ failure. [ABSTRACT FROM AUTHOR]

Background: Lung cancer rarely metastasizes to the breast, and breast metastasis of pulmonary pleomorphic carcinoma has not been previously reported. Case presentation: The patient was a 66-year-old woman who became aware of a mass in the right breast and visited a physician. She was referred to our department for close examination, upon which she was diagnosed with double cancer (right breast cancer and left lung cancer). Needle biopsy findings for the mammary tumor were similar to those for the lung biopsy specimen, but spindle cell or metaplastic carcinoma were possibilities. The initial diagnosis was primary breast cancer. Left upper lobectomy and lymph node dissection were performed for left lung cancer. Both the lung and mammary tumors grew rapidly during the wait for surgery. The white blood cell count was within the normal range at the first examination, but was markedly increased and remained at a high level after surgery for lung cancer. Preoperative chemotherapy was initially planned for the mammary tumor, but surgical treatment was selected in consideration of the clinical course, and right mastectomy and full thickness skin graft were performed. However, the disease rapidly aggravated and the patient died 5 months after the first examination. Conclusion: The final diagnosis was pulmonary pleomorphic carcinoma with metastasis to the breast on postoperative histopathological examination. We describe this case as the first reported example of breast metastasis of pulmonary pleomorphic carcinoma. [ABSTRACT FROM AUTHOR]

Fulminant myocarditis is a rare but fatal serious disease that may cause prolonged native cardiac dysfunction with multiorgan failure despite temporary mechanical circulatory support with percutaneous venoatrial extracorporeal membrane oxygenation (VA-ECMO) or intraaortic balloon pumping (IABP). A 26-year-old man with fulminant myocarditis developed life-threatening multiorgan failure after 8 days support by VA-ECMO and IABP. He was transferred to our institution with prolonged cardiac dysfunction on hospital day 8; massive pulmonary edema developed into severe pulmonary dysfunction. Immediately after admission, VA-ECMO and IABP were switched to a paracorporeal pneumatic left ventricular assist device (LVAD) and right centrifugal ventricular assist device with an ECMO circuit shunting from the right ventricle to the pulmonary artery (RVAD-ECMO). After intensive care focusing on respiratory dysfunction, ECMO was successfully weaned, and the right ventricular assist device was switched to a durable paracorporeal pneumatic right ventricular assist device. The paracorporeal bi-ventricular assist devices were finally replaced with an implantable non-pulsatile LVAD on hospital day 181. Currently, 1 year after discharge, the patient is at home awaiting heart transplantation. Combined LVAD and RVAD-ECMO appear to be useful for resolving severe pulmonary edema due to unnecessarily long VA-ECMO support as well as kidney or liver dysfunction caused by circulatory collapse. [ABSTRACT FROM AUTHOR]

Donor and recipient characteristics, as well as donor-recipient matching, affect clinical outcomes after heart transplantation (HTx). This study aimed to clarify how donor and recipient characteristics affect the clinical course after HTx. The medical records of all the patients who underwent HTx at the National Cerebral and Cardiovascular Center from 1999 to 2014 were retrospectively reviewed. Sixty-one patients (48 males) underwent HTx. Six recipients (9.8 %) developed primary graft dysfunction (PGD) determined by criteria recently established at a consensus conference. Development of PGD was associated with high-dose inotropic support for the donor heart and a history of stroke in the recipient ( p = 0.04 and p = 0.002, respectively). Recipients with PGD had higher right atrial pressure (RAP) and lower cardiac output (CO) compared with those without PGD at 6 months after HTx (RAP, 6.8 ± 3.6 vs. 2.8 ± 2.2 mmHg, p < 0.001; CO, 4.6 ± 0.8 l vs. 5.8 ± 1.2 l/min, p = 0.02). With respect to survival, patients with PGD had a 5-year survival rate equivalent to those without PGD (83.3 vs. 93.3 %, p = 0.23). High-dose inotropic support for the donor heart and a history of stroke in the recipient are significant predictive factors for the development of PGD. However, recipients with PGD demonstrate mid-term survival comparable to those without PGD. [ABSTRACT FROM AUTHOR]

Objectives: Although implantable left ventricular assist device use as a bridge to heart transplantation is increasing, its permanent use as destination therapy is not permitted in Japan. This retrospective review assessed early and mid-term outcomes of implantable continuous-flow left ventricular assist device compared with extracorporeal pulsatile-flow left ventricular assist device implantation. Issues regarding left ventricular assist device as destination therapy are discussed. Methods: From January 2009 to September 2013, 72 patients underwent left ventricular assist device implantation at our institute. Forty patients were supported by extracorporeal pulsatile-flow left ventricular assist devices (ex-VAD group) and 32 patients with implantable continuous-flow left ventricular assist devices (im-VAD group). Results: The median duration of ventricular assist device support was 563 days. The actuarial survival rates at 1 and 3 years were 92.3 and 79.2 % in the ex-VAD group and 96.4 and 72.3 % in the im-VAD group, respectively. Approximately 50 % of patients in both groups developed cerebrovascular complications within 1 year postoperatively. Six months post-implantation, almost 90 % of the ex-VAD group patients suffered exit-site infection compared with about 50 % in the im-VAD group. Readmission rate was 1.74 per patient-year; major causes were driveline exit-site infection (52 %) and cerebrovascular complication (14 %). Conclusions: Early and mid-term outcomes were satisfactory after both extracorporeal pulsatile-flow left ventricular assist device and implantable continuous-flow left ventricular assist device implantation, although a considerable level of postoperative complications was observed. More data after left ventricular assist device surgery are needed to enable its consideration as a destination therapy option in Japan. [ABSTRACT FROM AUTHOR]

Since pulmonary hypertension (PH) due to left-sided heart failure (HF) with elevated pulmonary vascular resistance (PVR) is contraindication for heart transplantation (HTx), correct evaluation of reversibility in PVR is essential for adequate therapeutic decision-making. However, guidelines or recommended protocols for pharmacological testing to evaluate the reversibility of PVR have not been established yet. In this report, we presented a 34-year-old male with advanced HF complicated by severe PH with high PVR [5.93 Wood units (WU)] who was deemed eligible for HTx. To evaluate his HTx candidacy, oxygen inhalation test was applied during right heart catheterization (RHC) and PVR was drastically decreased to 2.29 WU. At that time, acute response test to adaptive servo-ventilation (ASV) was also applied and use of ASV temporarily but substantially decreased PVR to 2.15 WU. From the results of both oxygen inhalation test and acute response test to ASV, reversibility of PVR in this patient was confirmed, and the patient was approved as HTx candidate and received left ventricular assist device (LVAD) implantation for bridge to transplant. After LVAD implantation, PVR substantially and persistently decreased to 2.4 WU. These findings indicate that acute response test to ASV during RHC may be a possible modality to evaluate the reversibility of PVR in HF patients with PH complicated by elevated PVR. [ABSTRACT FROM AUTHOR]

The clinical relevance of transcranial Doppler (TCD) detection of micro-embolic signals (MES) in patients with ventricular assist devices (VADs) has been described. However, all of the previous studies concerning TCD in patients with VADs were conducted in patients with old devices; the clinical relevance of TCD in patients with newer devices has not been fully elucidated. We recently encountered a patient with a continuous-flow VAD with hemolysis. TCD monitoring was useful for the direct evaluation of micro-emboli in this patient. A 50-year-old male who underwent HeartMate II VAD (Thoratec Corporation; Pleasanton, CA) implantation with a diagnosis of ischemic cardiomyopathy 15 months prior was admitted to our institution because of findings suggestive of hemolysis, such as elevated lactate dehydrogenase (LDH) and total bilirubin. Unfractionated heparin was started after admission and hemolysis gradually improved. On admission, TCD detected 146 MES during 30 min of monitoring. During the hospital course, the MES count decreased to 20 signals on hospital day 4 and further decreased to 2 signals on hospital day 15 along with decreases in LDH and total bilirubin. Since hemolysis in VAD patients is thought to be associated with thromboembolic outcomes, MES detected by TCD indicate subclinical micro-emboli. TCD monitoring may be useful for assessing the risk of thromboembolic events in newer continuous-flow VAD patients through direct visualization of micro-emboli. [ABSTRACT FROM AUTHOR]

A 59-year-old man who had been previously diagnosed with congenitally corrected transposition of the great arteries at the age of 35 years became a candidate for heart transplantation. At the age of 57 years, he was referred to our hospital and underwent implantation of a left ventricular assist device (EVAHEART; Sun Medical Technology Research Corp., Suwa City, Japan) because of worsening ventricular function and was listed as a heart transplant candidate. A donor appeared when the patient was 59 years. A three-dimensional replica was made using data from computed tomography angiography. The three-dimensional replica was made of soft rubber (crossMedical, Inc., Kyoto, Japan), which enabled the surgeons to understand the relationship between the great arteries and chambers. After repeated dry laboratories using this replica, the patient underwent successful heart transplantation. [ABSTRACT FROM AUTHOR]

Purpose: We evaluated the feasibility of off-pump minimally invasive direct coronary artery bypass (MIDCAB) in combination with robotic harvesting of the left internal mammary artery (LIMA). Methods: Since 2004, 33 patients [average age, 64 years; 27 males (82 %)] have undergone MIDCAB with robotic LIMA harvesting performed through the fourth or fifth intercostal space with guidance by enhanced computed tomography (CT). Results: No deaths or major adverse cardiac events occurred. Robotic LIMA harvesting was completed in 30 cases (91 %), while three cases (9 %) required conversion to a median sternotomy due to bleeding. The risk of LIMA injury significantly increased with age ( p = 0.0012). For the 30 successful cases, the average harvest time was 68 min, and the average intraoperative blood loss was 306 ml, with only three patients (9 %) requiring a transfusion. The graft flow was measurable in all cases (average, 34 ml/minute). All grafts were shown to be patent in postoperative evaluations, although CT revealed that the LIMA in one patient was anastomosed to an untargeted artery. Conclusions: Off-pump MIDCAB in combination with robotic harvesting of the LIMA is a reasonable and less invasive procedure than the standard procedures. Potential problems include difficulty controlling bleeding from the graft, especially in elderly patients, and proper identification of the target artery. [ABSTRACT FROM AUTHOR]

Background: Triple-negative breast cancers (TNBC) are defined as not having amplification of the estrogen receptor, progesterone receptor, or epidermal growth factor receptor 2. Recovery of patients is, currently, severely limited after diagnosis of metastatic TNBC, with fewer than 30 % of patients surviving more than 5 years. The most effective therapy to date is chemotherapy, which has been unsuccessful because of lack of therapeutic targets for these aggressive cancers. To identify new molecular targets for TNBC, we have developed a novel method for drug discovery using active compounds for identification of pharmacodynamic biomarkers. Methods: We used chemical informatics to design a small-molecule library with structural diversity. This library was used to screen for compounds that selectively inhibit proliferation of TNBC cell lines. Different gene-expression profiles in cell lines before and after the addition of selected compounds were analyzed and compared with those of control cells. Results: We identified ( E)-3-(3,4-dihydroxybenzylidene)benzofuran-2(3 H)-one (DBBF) which specifically inhibited proliferation of a TNBC cell line, MDA-MB-468, with an IC of 2.4 μ M. Microarray analysis identified several signaling pathways, including the irinotecan pathway, which changed specifically in the TNBC cell lines on addition of DBBF. Conclusion: We have developed a novel research strategy that involves screening of selective inhibitors of TNBC cell line proliferation that can be used for identification of pharmacodynamic biomarkers for TNBC. The discovery of new pathways by this technique should lead to the identification of new therapeutic targets for this aggressive cancer. [ABSTRACT FROM AUTHOR]

Cardiac allograft vasculopathy (CAV) is a major cause of mortality after transplantation. We treated a 44-year-old female with off-pump coronary artery bypass grafting (OPCAB) 4 years after heart transplantation. Annual examinations, including coronary angiography and intravenous ultrasound (IVUS), revealed a severe lesion in the left main trunk. The left internal mammary artery was successfully anastomosed to the left anterior descending artery in an off-pump manner. To ensure that patients have a good long-term outcome after heart transplantation, routine examinations, including IVUS, are crucial, because of the nature of CAV. OPCAB is a good option for a left main trunk lesion due to CAV. [ABSTRACT FROM AUTHOR]

Despite continual improvements in ventricular assist device (VAD) therapy, various clinical issues are emerging. Importantly, various types of thromboembolic complications have been reported to date. Recently, we encountered a rare continuous-flow VAD-related thromboembolic event that resulted in acute myocardial infarction. A 26-year-old female who just underwent HeartMate II VAD implantation suddenly developed widespread anterolateral myocardial infarction on postoperative day 16. Echocardiography and aortography revealed a large thrombus on the left coronary cusp of the aortic valve that almost completely occluded the left coronary ostium. After VAD implantation, her aortic valve did not open, even at relatively low pump speeds; this was thought to be one of the causes for thrombus formation. Continuous suction of blood from the left ventricle and non-pulsatile flow into the ascending aorta resulted in a continuously closed aortic valve and stagnation of blood in the coronary cusp. Furthermore, both small body size (body surface area <1.3 m) and postoperative right ventricular failure may have exacerbated blood stagnation and thrombus formation in this patient. We should have adjusted the anticoagulation and antiplatelet therapy protocols based on the patient's condition. She underwent off-pump coronary artery bypass surgery and remained in clinically stable condition afterwards. [ABSTRACT FROM AUTHOR]