Two-Year Clinical Outcome of MitraClip Transcatheter Edge-to-Edge Repair From the J-MITRA Registry Data.

BACKGROUND: The introduction of transcatheter edge-to-edge repair for moderate-to-severe or severe mitral regurgitation (MR) utilizing the MitraClip system became reimbursed and clinically accessible in Japan in April 2018. This study presents the 2-year clinical outcomes of all consecutively treated patients who underwent MitraClip implantation in Japan and were prospectively enrolled in the Japanese Circulation Society-oriented J-MITRA registry.Methods and Results: Analysis encompassed 2,739 consecutive patients enrolled in the J-MITRA registry with informed consent (mean age: 78.3±9.6 years, 1,550 males, STS risk score 11.7±8.9), comprising 1,999 cases of functional MR, 644 of degenerative MR and 96 in a mixed group (DMR and FMR). The acute procedure success rate was 88.9%. After MitraClip implantation, >80% exhibited an MR grade ≤2+ and the trend was sustained over the 2 years. Within this observation period, the mortality rate was 19.3% and the rate of heart failure readmissions was 20.6%. The primary composite endpoint, inclusive of cardiovascular death and heart failure readmission, was significantly higher in patients with functional MR than in with degenerative MR (32.0% vs. 17.5%, P<0.001). CONCLUSIONS: The 2-year clinical outcomes after MitraClip implantation were deduced from comprehensive data within an all-Japan registry.

[Precautions for Coronary Artery Reconstruction in Aortic Root Replacement].

Aortic root replacement is based on the Bentall procedure, and if appropriate cases are selected, valve-sparing surgery has good results. However, peri-operative myocardial infarction has been reported as a serious morbidity, and coronary artery reconstruction must be performed preventing this complication. Our results also indicate that prevention of kinking of the right coronary artery was associated with an improved prognosis. We believe that the enlarged sinus of Valsalva was replaced by a composite graft, the ostium of the right coronary artery was consequently located distance away from the graft. By reconstructing the right coronary artery in a left posterior and cephalic position, i.e., by traction toward the left shoulder, we can compensate for this misalignment and prevent kinking. Bentall procedure with a prosthetic composite graft has been a gold standard procedure as an aortic root replacement. When appropriate cases are selected, valve-sparing surgery can yield better results. However, peri-operative myocardial infarction has been reported as a serious morbidity. In addition, our present clinical analysis revealed that prevention of kinking of the right coronary artery is associated with an improved long-term prognosis. The technical aspects of coronary artery reconstruction are therefore of paramount importance. In particular, the more likely the right coronary artery is to be misaligned and kinked. The larger the sinus of Valsalva, the more likely the right coronary artery is to be misaligned and kinked. After excision of the enlarged sinus of Valsalva and replacement with an adequate size of prosthetic composite graft, the optimal position for the reattached right coronary button should be altered from the preoperatively deviated position due to the aneurysmal sinus of Valsalva. We believe that reconstructing the right coronary artery in a cephalad position and in a slightly counterclockwise direction by rotating the tip of the right coronary button towards the left shoulder may compensate for potential misalignment and help prevent kinking of the critical branch.

Clinical and Sociodemographic Factors Associated With Health-Related Quality of Life in Patients With Adult Congenital Heart Disease　- A Nationwide Cross-Sectional Multicenter Study.

BACKGROUND: Little is known about clinical or sociodemographic factors that influence health-related quality of life (HRQoL) in patients with adult congenital heart disease (ACHD).Methods and Results: We conducted a nationwide prospective cross-sectional multicenter study at 4 large ACHD centers in Japan. From November 2016 to June 2018, we enrolled 1,223 ACHD patients; 1,025 patients had an HRQoL score. Patients completed a questionnaire survey, including sociodemographic characteristics, and the 36-Item Short-Form Health Survey (SF-36). To determine factors associated with HRQoL, correlations between 2 SF-36 summary scores (i.e., physical component score [PCS] and mental component score [MCS]) and other clinical or sociodemographic variables were examined using linear regression analysis. In multivariable analysis, poorer PCS was significantly associated with 11 variables, including older age, higher New York Heart Association class, previous cerebral infarction, being unemployed, and limited participation in physical education classes and sports clubs. Poorer MCS was associated with congenital heart disease of great complexity, being part of a non-sports club, current smoking, and social drinking. Student status and a higher number of family members were positively correlated with MCS. CONCLUSIONS: This study demonstrates that HRQoL in ACHD patients is associated with various clinical and sociodemographic factors. Further studies are needed to clarify whether some of these factors could be targets for future intervention programs to improve HRQoL outcomes.

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

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

Development of modified laser Doppler flowmetry device for real-time monitoring of esophageal mucosal blood flow: a preclinical assessment with an animal model.

This study aimed to modify a laser Doppler flowmeter designed and assembled at our institute. After measuring sensitivity evaluation in ex vivo experiments, we confirmed the efficacy of this new device for monitoring real-time esophageal mucosal blood flow changes after thoracic stent graft implantation by simulating various clinical situations in an animal model. Thoracic stent graft implantation was performed in a swine model (n = 8). Esophageal mucosal blood flow decreased significantly from baseline (34.1 ± 18.8 ml/min/100 g vs. 16.7 ± 6.6 ml/min/100 g, P < 0.05) in the lower esophagus (Th6-Th8) where the stent graft covered the aorta. In the hemorrhagic shock model (shock index ≥ 1.0), esophageal mucosal blood flow showed a remarkable change from baseline in the upper esophagus (Th1-Th3), where the stent graft did not cover the aorta (20.8 ± 9.8 ml/min/100 g vs. 12.9 ± 8.6 ml/min/100 g, P < 0.01); however, it returned to the baseline value within a 30-min period. Mucosal blood flow remained stable in the esophagus, where the stent graft did not cover the aorta. After elevating the mean blood pressure to > 70 mmHg with continuous intravenous noradrenaline infusion, esophageal mucosal blood flow increased significantly in both regions; however, the reaction was different between the two regions. Our newly developed laser Doppler flowmeter could measure real-time esophageal mucosal blood flow changes in various clinical situations during thoracic stent graft implantation in a swine model. Hence, this device can be applied in many medical fields by downsizing it.

[Severe Carotid Artery Disease:Monitoring and Precautions for Prevention of Cerebral Ischemia].

Cerebrovascular complications in cardiovascular surgery have long been documented. It is very important to diagnose and evaluate the stenosis of carotid artery before cardiovascular surgery. When indicated, carotid endarterectomy( CEA) or carotid artery stenting( CAS) for severe carotid artery stenosis may be considered before cardiovascular surgery. However, it has not been necessary performed in the real-world. It seems to be appropriate to maintain a mean arterial pressure of 50-70 mmHg during cardiovascular surgery with extracorporeal circulation. In addition, perioperative cerebral metabolism and circulation monitoring using a near-infrared cerebral oxygen monitor such as rSO2 is very useful from the viewpoint of preventing exacerbation of cerebral ischemia.

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

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

Changes in the Quality of Life of Patients with Left Ventricular Assist Device and their Caregivers in Japan: Retrospective Observational Study.

Left ventricular assist devices (LVAD) improve quality of life (QOL) in many patients with end-stage severe heart failure, but not in some patients. In addition, the burden on caregivers is expected to increase after LVAD patients are discharged. Our study aimed to investigate the impact of LVAD on the QOL of patients and caregivers. Thirty-two LVAD patients were assessed for changes in QOL, mental status, and activity level using the Euro QOL (EQ-5D-5L), Short Form 12 (SF-12), Minnesota Living with Heart Failure Questionnaire, Hospital Anxiety and Depression Scale (HADS), and Frenchay Activities Index. Twenty-four caregivers were assessed for changes in QOL, mental status, and burden of care using the EQ-5D-5L, SF-12, HADS, and Burden Index of Caregiver (BIC-11). The LVAD patients and caregivers responded contemporaneously regarding two points: pre-and post-LVAD. Patients' physical and mental QOL was significantly improved, but not social QOL and activity level. Caregivers' QOL and burden of care did not change, and anxiety was reduced (p = 0.028). The patients were divided into two groups based on whether EQ-5D-5L was improved: twelve patients in the unimproved group (UG) and twenty patients in the improved group (IG). In the UG, 50% had LVAD-related strokes (p = 0.001, IG: 0%), and their social QOL decreased (p = 0.023). The activity levels improved in the IG. Multi-dimensional analyses on the QOL in LVAD patients yielded mixed results. Anticipated benefits derived from LVAD therapy may be limited by LVAD-related complications such as stroke that negatively impacts on the QOL.

Usefulness of Right Ventricular Free Wall Strain Obtained with Two-Dimensional Speckle-Tracking Echocardiography in Patients with Repaired Tetralogy of Fallot and Pulmonary Regurgitation.

Right ventricular (RV) dysfunction caused by chronic pulmonary regurgitation (PR) is a major determinant of clinical outcome in adults with repaired tetralogy of Fallot (rTOF). However, the accurate assessment of RV function by conventional echocardiography remains challenging. This study tested the feasibility and usefulness of RV free-wall (RVFW) strain obtained by two-dimensional (2D) speckle-tracking echocardiography (STE) in evaluation of RV function in adults with rTOF by comparing cardiac magnetic resonance (CMR) imaging. We enrolled 22 consecutive patients (male/female, 8/14; mean age, 25.0 years) with rTOF who underwent transthoracic echocardiography at Tohoku University Hospital from July 2016 to June 2019. We measured RVFW strain by STE and compared them with 22 hemodynamically normal subjects (NOR) (male/female, 9/13; mean age, 32.0 years). The correlation between RV strain and CMR-derived RV ejection fraction (RVEF) or PR fraction (PRF) were also evaluated. All rTOF patients had more than moderate PR but were near asymptomatic. RVFW longitudinal strain (RVFW-LS) was significantly decreased in the rTOF group compared with that in the NOR group (-19.6 vs. -24.7, P < 0.01). In the rTOF group, RVFW-LS correlated with PRF (r = 0.44, P < 0.05), whereas RVFW circumferential strain at the mid-ventricular level correlated with RVEF (r = 0.57, P < 0.01). Intra-observer variability of RVFW strain was acceptable. These results indicate that RV systolic function and PR severity in rTOF could be assessed by RVFW strain measured by 2D STE. This method is feasible and can be used as a complement to CMR imaging.

A case series describing the risk of periodontal disease in Marfan syndrome patients harboring a possible aortic aneurysm or dissection.

BACKGROUND: Marfan syndrome (MFS) is a systemic disorder of connective tissues caused by insufficient elastic fiber formation that leads to structural weakness and results in various tissue disorders, including cardiovascular and periodontal disease. Notably however, the risk of periodontal disease in MFS patients affected by an aortic aneurysm or dissection has not yet been clarified. METHODS: We investigated the periodontal condition in the following three groups: MFS patients diagnosed with an aortic aneurysm or dissection with a planned aortic surgery (MFS surgery), MFS patients who had already undergone aortic surgery (MFS post-surgery) and healthy control patients (Healthy). The periodontal condition of all of these patients was evaluated at their first visit, reassessed again at two-month after the first visit, and evaluated again at a six-month follow-up after the reassessment. RESULTS: A total of 14 participants, 3 MFS surgery patients, 4 MFS post-surgery patients and 7 healthy control volunteers were examined. Saliva examinations revealed no significant differences between any of the groups at the first visit, reassessment, or follow-up. Interestingly, the MFS surgery cases showed a higher BOP and PISA at the first visit and follow-up compared with the other groups. In contrast, the MFS surgery patients showed an improvement in their LVDd and EF values, both markers of cardiac function, at the reassessment and follow-up compared with the first visit. CONCLUSIONS: MFS associated with an aortic aneurysm or dissection leads to a higher risk of periodontal disease, indicating the need for more frequent oral hygiene maintenance in these patients. In addition, MFS patients who undergo frequent professional cleaning of their teeth show a lower onset of cardiovascular disease, suggesting that professional oral hygiene in these cases contributes to a healthier condition.

[Treatment Strategy for Ruptured Thoracic Aortic Aneurysm].

Ruptured thoracic aortic aneurysm carries significant morbidity and mortality requiring emergent repair for lifesaving. Open repair has been the standard option of treatment;however, TEVAR has evolved as a first-line treatment option for cases in whom specific anatomical conditions are deemed to be suitable for this intravascular repair. As for ruptured aortic aneurysm, it is particularly important to evaluate the appropriate range of treatment with a device by preoperative computed tomography( CT) scan.

What does complete revascularization mean in 2021? - Definitions, implications, and biases.

PURPOSE OF REVIEW: Coronary revascularization is known to be an excellent treatment for coronary artery disease. However, whether incomplete myocardial revascularization compromises long-term outcomes, as compared to complete revascularization (CR), remains contentious. Herein, we review the concept of and evidence on CR/incomplete revascularization (ICR) and discuss future perspectives. RECENT FINDINGS: When possible, achieving CR in coronary artery bypass grafting is desirable; nonetheless, ICR is also a reasonable option to balance the therapeutic benefits against the risks. SUMMARY: Although angiography-based assessment currently remains the standard of care, fractional flow reserve guidance may reduce the number of lesions requiring revascularization, which may be helpful for an appropriate surgical revascularization strategy. In particular, utilizing this approach may refine hybrid revascularization procedures, especially among high-risk patients.

A Case of an Increase in Prothrombin Time-International Normalized Ratio by Interaction Between Warfarin and Baloxavir Marboxil in a Patient on Implantable Ventricular Assist Device.

BACKGROUND: Baloxavir marboxil (BM) is a novel drug with a cap-dependent endonuclease inhibitory action for influenza A or B; it is highly safe and requires just a single oral dose. Patients with severe heart failure use implantable ventricular assist device (iVAD) until transplantation, but they have an increased risk of thrombosis development. Their warfarin is administered based on point-of-care testing (POCT) with a strict control of prothrombin time-international normalized ratio (PT-INR). CASE REPORT: Here, we report a case of a patient with iVAD whose PT-INR was significantly increased from the target range after BM administration. The patient was a 45-year-old man and transplanted with iVAD; warfarin treatment was started when his PT-INR target range was 3.0-3.5. At home, he frequently self-measured PT-INR by POCT and precisely controlled the warfarin dose. He had a fever, was diagnosed with influenza A and was administered BM 40 mg. Thereafter, his PT-INR continued to increase, reaching 4.8 on day 12 of BM administration, exceeding his target range; warfarin was skipped for 1 day. In this case, based on the history of BM administration and clinical course, the increase in PT-INR could be due to BM. Considering the interaction between warfarin and BM, we suspected a possibility of competition for protein-binding sites. Increased PT-INR in the patient was detected early by POCT and thus severe bleeding was avoided. CONCLUSION: Strict monitoring of PT-INR when using BM in patients taking warfarin is of clinical importance.

Can the intermittent low-speed function of left ventricular assist device prevent aortic insufficiency?

Aortic insufficiency (AI) is known to associate with a persistently closed aortic valve during continuous-flow ventricular assist device support. Some devices carry an intermittent low-speed (ILS) function, which facilitates aortic valve opening, but whether this function prevents AI is unknown. In this study, the Jarvik 2000 device, which is programmed to reduce the pump speed each minute for 8 s, was chosen to examine this potential effect. Prospectively collected data of 85 heart transplant-eligible Jarvik 2000 recipients who met the study criteria (no pre-existing AI and aortic valve surgery) were retrospectively analyzed for the incidence, correlating factors, and clinical outcomes of de novo AI. All data were provided by the Japanese Registry for Mechanically Assisted Circulatory Support. De novo AI occurred in 58 patients, 23 of whom developed at least moderate AI during a median support duration of 23.5 months. Freedom from moderate or greater AI was 84.4%, 66.1% and 60.2% at 1, 2 and 3 years, respectively. Multivariate analyses revealed that progressive AI was correlated with decreased pulse pressure after implantation (hazard ratio 1.060, 95% confidence interval 1.001-1.127, p = 0.045). No correlation was found for mortality or other adverse events, including stroke, bleeding, infection, pump failure, hemolysis, and readmission. The benefit of the Jarvik 2000's current ILS mode against AI appears to be minimal. However, in this limited cohort where all recipients underwent implantation as a bridge to transplantation, the impact of de novo progressive AI on other clinical adversities was also minimal.

New hemostatic technique with combined use of Hydrofit® and Surgicel®: an in vitro and in vivo study.

We developed an effective hemostatic technique using Hydrofit® and Surgicel® simultaneously. The aim of this study was to demonstrate the hemostatic efficacy of the Hydrofit® and Surgicel® combination technique through an in vitro experiment and to elucidate mid-term consequences of the combined components through an in vivo experiment. For the in vitro experiment, a closed circuit using a heparin-coated cardiopulmonary bypass circuit and a prosthetic graft was created. The amount of bleeding from the prosthetic graft was measured, and the following three hemostatic methods were applied: only gauze compression in control group, Hydrofit® application in Hydrofit group, Surgicel® spread Hydrofit® application in Hydrofit and Surgicel (HS) group, respectively. In the in vivo experiment, Hydrofit® and/or Surgicel® were implanted under skin on the back of rats (n = 10) at 4 points. In the control group, only an incision was made; in the Hydrofit, Surgicel, and HS groups, Hydrofit® and/or Surgicel® was implanted. One and three months later, each of the five rats were killed and in each section histopathologic examination was carried out. In the in vitro experiment, the amount of bleeding was 7.84 ± 1.08, 2.26 ± 1.02, and 0.87 ± 0.38 ml in the control, Hydrofit, and HS groups, respectively. The amount of bleeding in the HS group was more suppressed than in the Hydrofit group (p = 0.012). In the in vivo experiment, the maximal depth diameter of each remaining hemostatic sealant was measured. After 3 months, the diameter was 0, 2289.0 ± 768.2, 3850.3 ± 935.8 µm in Surgicel, Hydrofit and HS groups, respectively. The diameter was significantly increased in the HS group compared with the Surgicel and Hydrofit groups (p < 0.001, respectively,). In conclusion, the combination of Hydrofit® and Surgicel® was effective in achieving hemostasis. The remnants of Hydrofit® and Surgicel® were present for a long time in the tissues which could compress the surrounding tissue.

Aortic Insufficiency Causes Symptomatic Heart Failure during Left Ventricular Assist Device Support.

De novo aortic insufficiency is often documented during long-term left ventricular assist device (LVAD) support, despite the absence of aortic insufficiency at the time of LVAD implantation. However, whether aortic insufficiency affects long-term mortality and symptomatic heart failure in LVAD-supported patients remains controversial. We aimed to examine whether aortic insufficiency development influenced mortality and symptomatic heart failure following LVAD implantation. Fifty-three patients who underwent durable LVAD implantation between January 1, 2008 and April 31, 2017 were retrospectively examined in a single center institute. After discharge, we performed the echocardiographic examination in accordance with the Japanese registry for the mechanically assisted circulatory support protocol. Aortic insufficiency was graded on an interval scale (severe = 4, moderate = 3, mild = 2, trivial or none = 1). Kaplan-Meier estimates for long-term mortality at the follow-up were generated. We used a logistic regression model to identify risk factors for symptomatic heart failure. The overall median duration of LVAD support was 856.3 ± 430.8 days (range, 12-1,744 days). We did not observe a significant difference in long-term mortality in patients with aortic insufficiency ≥ 3 grade compared with patients with aortic insufficiency < 3 grade (P = 0.767; log-rank). Aortic insufficiency was associated with an increased risk for heart failure event after discharge (odds ratio, 4.12; confidence interval, 1.48-16.93; P = 0.005). Aortic insufficiency was an independent risk factor for symptomatic heart failure and was not associated with long-term mortality. Aortic insufficiency progression was associated with symptomatic heart failure.

[Total Aortic Arch Replacement after a Prior Ascending Aortic Replacement].

Surgeries for non-dissected aortic arch diseases have been performed with increasing frequency in recent years. Accordingly, the awareness of the pitfalls in reoperation after a previous ascending aortic replacement is needed. Indications for redo total aortic arch replacement after a prior ascending aortic replacement include pseudoaneurysm formation at the distal anastomosis site and newly developed aortic arch aneurysms. At reoperation, we should take the assurance of safety during re-sternotomy into consideration. Cannulation sites should be strategically selected. The radiologic features of the high-risk re-sternotomy include a close approximation( <5 mm) between the sternum and the aorta or the previously placed vascular prosthesis and a presence of pseudoaneurysm underneath the sternum. In such cases, it is reasonable to establish partial cardiopulmonary bypass and selective cerebral perfusion via bilateral carotid artery cannulation prior to sternotomy to avoid disastrous neurological complications. Adhesions around a previously placed vascular prosthesis with innominate vein or main pulmonary artery can be troublesome;thus, care must be taken so as not to injure the surrounding vital organs. Liberal employment of hypothermia can be life-saving by preserving brain, heart and other vital end-organs at the expense of prolonged procedure time.

[Anomalous Origin of the Right Coronary Artery from the Pulmonary Artery Treated with Fistula Closure and Coronary Artery Bypass Grafting:Report of a Case].

An anomalous origin of the right coronary artery from the pulmonary artery (ARCAPA) is a rare congenital disease, and it sometimes remains unnoticed until cardiac symptoms appear in adulthood. We report an adult case of surgically treated ARCAPA. A 72-year-old male was diagnosed with ARCAPA by examination for heart failure. The origin of the right coronary artery (RCA) was dilated, and ischemic change was found in the RCA area by myocardial scintigraphy. Therefore, coronary artery bypass grafting to distal RCA was performed at first, then the fistula was closed using an autologous pericardial patch, and the dilated origin of RCA was resected. Postoperative scintigraphy showed disappearance of the ischemic pattern, and the patient was discharged without any symptom of heart failure.

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

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

Pre-clinical assessment of a prototype non-invasive diagnostic device to detect aortic aneurysms.

We have developed a non-invasive diagnostic device for treating thoracic aortic aneurysm that can be applied at a peripheral artery. This study aimed to examine how configuration and size of an aneurysm as well as endoluminal pressure affect our diagnostic device's ability to detect an aneurysm, using a pulsatile mock circulation. We created three different-sized (12, 16, and 20 mm) saccular and fusiform aneurysm models using silicone and incorporated them in a pulsatile perfusion circuit to evaluate vertical vessel wall velocity wave form at a location apart from the aneurysm. We also varied the pressure condition to evaluate the changes in the detected wave forms. In both fusiform and saccular aneurysm models, biphasic wave forms indicating the presence of aneurysm within the circuit were observed. Regarding aneurysm diameter, biphasic wave forms were observed in all aneurysm models. However, in the 12-mm model, which is relevant to the minimum diameter of clinical diagnostic criteria for an aneurysm relative to normal size, no biphasic waveform was detected when the endoluminal pressure was relatively low. In the 16- and 20-mm models, biphasic waveform was detected without being affected by the configuration and endoluminal pressure. The detectability of aneurysms within a pulsatile mock circulation using our non-invasive diagnostic device was not affected by the clinically relevant configuration and size of the aneurysm under slightly hypertensive endoluminal pressure condition. Low endoluminal pressure may lower the diagnostic sensitivity for relatively small saccular aneurysm.