Background:Bridge-to-decision (BTD) devices providing temporary mechanical circulatory support should be introduced to patients with advanced heart failure. This study evaluated the effectiveness and ...safety of a BTD device comprising an innovative extracorporeal continuous-flow temporary ventricular assist device (VAD) driven by a novel hydrodynamically levitated centrifugal flow blood pump.Methods and Results:Nine patients, comprising 3 with dilated cardiomyopathy, 3 with fulminant myocarditis, and 3 with ischemic heart disease, and 6 males, whose mean age was 47.7±8.1 years, were enrolled into the study. Six patients had Interagency Registry for Mechanically Assisted Circulatory Support profile 1, and 3 were profile 2. The primary endpoint was a composite of survival free from device-related serious adverse events and complications during circulatory support. Eight patients received left ventricular support, of whom 3 received concomitant right ventricular support using extracorporeal membrane oxygenation circuits, as a consequence of severe respiratory failure. One patient with fulminant myocarditis received biventricular support using the novel VAD system. After 19.0±13.5 days, 3 patients were weaned from circulatory support, because their native cardiac function recovered, and 6 patients required conversion to a durable device as a bridge-to-transplantation. One patient had non-disabling ischemic stroke episodes, and no patients died.Conclusions:This novel extracorporeal VAD system with a hydrodynamically levitated centrifugal pump can safely and successfully bridge patients with advanced heart failure to subsequent therapeutic stages.
Recurrence of cancer after curative surgery is a major problem after most cancer treatments. Increased sympathetic activity during the perioperative period could promote cancer cell invasion to blood ...vessels and angiogenesis, resulting in cancer metastasis. Recent studies showed that use of beta blockers can be associated with the prolonged survival of patients with cancer. The objective of this study is to evaluate the preventive effects of landiolol hydrochloride, which is an ultra-short-acting beta-1-selective blocker that has been developed in Japan, on reducing recurrence of cancer after curative surgery for patients with lung cancer.
The present study is a phase III, multicenter, randomized trial with two parallel groups of patients with lung cancer, comparing surgery alone and surgery with landiolol administration for three days during the perioperative period. A total of 400 patients will be enrolled from 12 Japanese institutions. The primary endpoint is two-year relapse-free survival and overall survival after curative surgery for lung cancer. The secondary endpoints are additional treatment after recurrence of cancer, safety events, and the incidence of postoperative complications.
The principal question addressed in this trial is whether landiolol can reduce recurrence of cancer after curative surgery for lung cancer.
Japan Registry of Clinical Trials, jRCT2011180004. Registered 17 January 2019.
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
.
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.
Postoperative cancer recurrence is a major problem following curative surgery. In a previous retrospective study of lung cancer surgery, we reported that administration of atrial natriuretic peptide ...(ANP) during the perioperative period reduced postoperative recurrence. We demonstrated that ANP inhibited the adhesion of cancer cells to vascular endothelium as a vasoprotective action. The objective of this study is to evaluate the effects of ANP on the incidence of postoperative cancer recurrence in lung cancer surgery.
The present study is a multicenter, randomized trial with two parallel groups of patients with lung cancer comparing surgery alone and surgery with ANP administration for 3 days during the perioperative period. A total of 500 patients will be enrolled from 10 Japanese institutions. The primary endpoint is 2-year relapse-free survival (RFS). The secondary endpoints are 2-year cancer-specific RFS, 5-year RFS, overall survival, the incidence of postoperative complications, and the completion rate of ANP treatment.
The principal question addressed in this trial is whether ANP with its vasoprotective action can reduce cancer recurrence following lung cancer surgery.
UMIN Clinical Trials Registry identifier: UMIN000018480 . Registered on 31 July 2015.
We report on the spectral cross-calibration results of the Konus-Wind, the Suzaku/WAM, and the Swift/BAT instruments using simultaneously observed gamma-ray bursts (GRBs). This is the first attempt ...to use simultaneously observed GRBs as a spectral calibration source to understand systematic problems among the instruments. Based on these joint spectral fits, we find that (1) although a constant factor (a normalization factor) agrees within 20% among the instruments, the BAT constant factor shows a systematically smaller value by 10%–20% compared to that of Konus-Wind, (2) there is a systematic trend that the low-energy photon index becomes steeper by 0.1–0.2 and
$E_{\rm peak}$
becomes systematically higher by 10%–20% when including the BAT data in the joint fits, and (3) the high-energy photon index agrees within 0.2 among the instruments. Our results show that cross-calibration based on joint spectral analysis is an important step to understanding the instrumental effects that could be affecting the scientific results from the GRB prompt emission data.
This paper presents a study on the spectral evolution of gamma-ray burst (GRB) prompt emissions observed with the Suzaku Wide-band All-sky Monitor (WAM). By making use of the WAM data archive, 6 ...bright GRBs exhibiting 7 well-separated fast-rise-exponential-decay (FRED) shaped light curves are presented, and the evaluated exponential decay time constants of the energy-resolved light curves from these FRED peak light curves are shown to indicate significant spectral evolution. The energy dependence of the time constants is well described with a power-law function,
$\tau$
(
$E$
)
$\propto$
$E^\gamma$
, where
$\gamma$
$\sim$
$-$
(0.34
$ \pm $
0.12) on average, although 5 FRED peaks show a consistent value of
$\gamma$
$=$
$-$
1
$/$
2, which is expected in synchrotron or inverse-Compton cooling models. In particular, 2 of the GRBs were located with accuracy sufficient to evaluate the time-resolved spectra with precise energy response matrices. Their behavior in spectral evolution suggests two different origins of emissions. In the case of GRB 081224, the derived 1-s time-resolved spectra are well described by a blackbody radiation model with a power-law component. The derived behavior of cooling is consistent with that expected from radiative cooling or expansion of the emission region. On the other hand, the other 1-s time-resolved spectra from GRB 100707A is well described by a Band GRB model as well as with the thermal model. Although relative poor statistics prevent us to conclude, the energy dependence in the decaying light curve is consistent with that expected in the former emission mechanism model.
The Suzaku Wide-band All-sky Monitor (WAM) consists of thick BGO anti-coincidence shields of the Hard X-ray Detectors (HXD). It views about half of the sky and has a geometrical area of 800 cm
$^2$
...per sdide and an effective area of 400 cm
$^2$
, even at 1 MeV. Hence, the WAM can provide unique opportunities to detect high-energy emission from GRBs and solar flares in the sub-MeV to MeV range. The WAM has detected more than 400 GRBs and 100 solar flares since its launch. This paper describes the in-flight performance of the HXD/WAM during the initial two years of operations, including the in-flight energy response, spectral and timing capabilities, and in-orbit background.
Anticoagulant therapy with vitamin K antagonists is recommended within 3 to 6 months after bioprosthetic valve replacement to prevent thromboembolic events. However, data regarding whether direct ...oral anticoagulants can be an alternative to warfarin in such patients are limited. The purpose of this study is to compare the efficacy and safety of edoxaban versus warfarin within 3 months after bioprosthetic valve replacement.BACKGROUND AND PURPOSEAnticoagulant therapy with vitamin K antagonists is recommended within 3 to 6 months after bioprosthetic valve replacement to prevent thromboembolic events. However, data regarding whether direct oral anticoagulants can be an alternative to warfarin in such patients are limited. The purpose of this study is to compare the efficacy and safety of edoxaban versus warfarin within 3 months after bioprosthetic valve replacement.The ENBALV trial is an investigator-initiated, phase 3, randomized, open-label, multicenter study. It involves patients aged 18 to 85 years undergoing bioprosthetic valve replacement at the aortic and/or mitral position. They are randomized 1:1 to receive either edoxaban or warfarin. Administration of edoxaban or warfarin is to be continued for 12 weeks after surgery. The primary outcome is the occurrence rate of stroke or systemic embolism at 12 weeks after surgery. The net clinical outcome is a composite of stroke, systemic embolism, or major bleeding, which is included in the secondary outcomes.METHODSThe ENBALV trial is an investigator-initiated, phase 3, randomized, open-label, multicenter study. It involves patients aged 18 to 85 years undergoing bioprosthetic valve replacement at the aortic and/or mitral position. They are randomized 1:1 to receive either edoxaban or warfarin. Administration of edoxaban or warfarin is to be continued for 12 weeks after surgery. The primary outcome is the occurrence rate of stroke or systemic embolism at 12 weeks after surgery. The net clinical outcome is a composite of stroke, systemic embolism, or major bleeding, which is included in the secondary outcomes.The ENBALV trial demonstrates the efficacy and safety of edoxaban compared with warfarin in patients early after bioprosthetic valve replacement, including patients with sinus rhythm, which will bring a significant benefit to patients in clinical practice.CONCLUSIONThe ENBALV trial demonstrates the efficacy and safety of edoxaban compared with warfarin in patients early after bioprosthetic valve replacement, including patients with sinus rhythm, which will bring a significant benefit to patients in clinical practice.Japan Registry of Clinical Trials (jRCT) 2051210209. 30 Mar 2022 https://jrct.niph.go.jp/latest-detail/jRCT2051210209 .TRIAL REGISTRATIONJapan Registry of Clinical Trials (jRCT) 2051210209. 30 Mar 2022 https://jrct.niph.go.jp/latest-detail/jRCT2051210209 .
We have performed a joint analysis of prompt emission from four bright short gamma-ray bursts (GRBs) with the Suzaku-WAM and the Konus-Wind experiments. This joint analysis allows us to investigate ...the spectral properties of short-duration bursts over a wider energy band with a higher accuracy. We find that these bursts have a high
$E_{\rm peak}$
, around 1MeV and have a harder power-law component than that of long GRBs. However, we can not determine whether these spectra follow the cut-off power-law model or the Band model.
We also investigated the spectral lag, hardness ratio, inferred isotropic radiation energy and existence of a soft emission hump, in order to classify them into short or long GRBs using several criteria, in addition to the burst duration. We find that all criteria, except for the existence of the soft hump, support the fact that our four GRBsamples are correctly classified as belonging to the short class. In addition, our broad-band analysis revealed that there is no evidence of GRBs with a very large hardness ratio, as seen in the BATSE short GRBsample, and that the spectral lag of our four short GRBs is consistent with zero, even in theMeV energy band, unlike long GRBs. Although our short GRBsamples are still limited, these results suggest that the spectral hardness of short GRBs might not differ significantly from that of long GRBs, and also that the spectral lag at high energies could be a strong criterion for burst classification.
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