Search

Aims: Hospitalizations are common in patients with heart failure and are associated with high mortality, readmission and economic burden. Detecting early signs of worsening heart failure may enable earlier intervention and reduce hospitalizations. The HeartLogic algorithm is designed to predict worsening heart failure using diagnostic data from multiple device sensors. The main objective of this analysis was to evaluate the sensitivity of the HeartLogic alert calculation in predicting worsening heart failure events (HFEs). We also evaluated the false positive alert rate (FPR) and compared the incidence of HFEs occurring in a HeartLogic alert state to those occurring out of an alert state., Methods: The HINODE study enrolled 144 patients (81 ICD and 63 CRT-D) with device sensor data transmitted via a remote monitoring system. HeartLogic alerts were then retrospectively simulated using relevant sensor data. Clinicians and patients were blinded to calculated alerts. Reported adverse events with HF symptoms were adjudicated and classified by an independent HFE committee. Sensitivity was defined as the ratio of the number of detected usable HFEs (true positives) to the total number of usable HFEs. A false positive alert was defined as an alert with no usable HFE between the alert onset date and the alert recovery date plus 30 days. The patient follow-up period was categorized as in alert state or out of alert state. The event rate ratio was the HFE rate calculated in alert to out of alert., Results: The patient cohort was 79% male and had an average age of 68 ± 12 years. This analysis yielded 244 years of follow-up data with 73 HFEs from 37 patients. A total of 311 HeartLogic alerts at the nominal threshold (16) occurred across 106 patients providing an alert rate of 1.27 alerts per patient-year. The HFE rate was 8.4 times greater while in alert compared with out of alert (1.09 vs. 0.13 events per patient-year; P < 0.001). At the nominal alert threshold, 80.8% of HFEs were detected by a HeartLogic alert [95% confidence interval (CI): 69.9%-89.1%]. The median time from first true positive alert to an adjudicated clinical HFE was 53 days. The FPR was 1.16 (95% CI: 0.98-1.38) alerts per patient-year., Conclusions: Results suggest that signs of worsening HF can be detected successfully with remote patient follow-up. The use of HeartLogic may predict periods of increased risk for HF or clinically significant events, allowing for early intervention and reduction of hospitalization in a vulnerable patient population., (© 2024 The Author(s). ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: Despite an increased incidence of chronic heart failure (HF) and sudden cardiac death (SCD), the use of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) is much lower in Japan than in Western countries. The HF Indication and SCD Prevention Trial Japan (HINODE) prospectively assessed the mortality rate, appropriately treated ventricular arrhythmias (VA), and HF in Japanese patients with a higher risk of HF., Methods and results: HINODE consisted of ICD, CRT-defibrillator (CRT-D), pacing, and non-device treatment cohorts. This subanalysis evaluated the impact of the implantation of high-voltage devices (HVD; ICD and CRT-D) in 171 Japanese patients. We compared all-cause mortality, VA, and HF events between elderly (age >70 years at study enrollment) and non-elderly HVD recipients. The estimated survival rate through 24 months in the HVD cohort was 85.8% (97.5% lower control limit 77.6%). The risk of all-cause mortality was increased for the elderly vs. non-elderly (hazard ratio [HR] 2.82; 95% confidence interval [CI] 1.01-7.91; P=0.039), but did not differ after excluding ICD patients with CRT-D indication (HR 2.32; 95% CI 0.79-6.78; P=0.11). There were no differences in VA and HF event-free rates between elderly and non-elderly HVD recipients (P=0.73 and P=0.55, respectively)., Conclusions: Although elderly patients may have a higher risk of mortality in general, the benefit of HVD therapy in this group is comparable to that in non-elderly patients.

Aims: The HINODE study aimed to analyse rates of mortality, appropriately treated ventricular arrhythmias (VA), and heart failure in Japanese patients and compared with those in Western patients., Methods and Results: After treatment decisions following contemporary practice in Japan, patients were prospectively enrolled into four cohorts: (i) internal cardioverter-defibrillator (ICD), (ii) cardiac resynchronization therapy (CRT) defibrillator (CRT-D), (iii) standard medical therapy ('non-device': ND), or (iv) pacing (indicated for CRT; received pacemaker or CRT pacing). Cohorts 1-3 required a left ventricular ejection fraction ≤35%, a history of heart failure, and a need for primary prevention of sudden cardiac death based on two to five previously identified risk factors. Endpoint outcomes were adjudicated by the independent committees. ICD and CRT-D cohorts, considered as high-voltage (HV) cohorts, were pooled for Kaplan-Meier analysis and propensity-matched to Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) arm B and C patients. The study enrolled 354 patients followed for 19.6 ± 6.5 months, with a minimum of 12 months. Propensity-matched HV cohorts showed comparable VA (P = 0.61) and mortality rates (P = 0.29) for HINODE and MADIT-RIT. The ND cohort presented a high crossover rate to ICD therapy (6.1%, n = 7/115), and the CRT-D cohort showed elevated mortality rates. The pacing cohort revealed that patients implanted with pacemakers had higher mortality (26.0%) than those with CRT-Pacing (8.4%, P = 0.05)., Conclusions: The mortality and VA event rates of landmark trials are applicable to patients with primary prevention in Japan. Patients who did not receive guideline-indicated CRT devices had poor outcomes., (© 2022 Guidant Europe NV as part of Boston Scientific Corp. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: Randomized trials in Western countries have provided evidence that prophylactic implantable cardioverter-defibrillator (ICD) therapy reduces mortality in heart failure (HF) patients with reduced left ventricular ejection fraction. However, the risk of life-threatening ventricular arrhythmias in Japanese HF patients sharing similar risk factors is still unknown., Methods: The Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan trial (NCT03185832) is a prospective, multicenter registry designed to collect data on ventricular arrhythmia, HF events, and mortality in Japanese HF patients. Japanese patients with HF and 2-5 predefined risk factors who were indicated for cardiac device implantation based on European Society of Cardiology guidelines were enrolled in four treatment arms: implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy defibrillator (CRT-D), HF pacing (PA; Pacemaker and cardiac resynchronization pacemaker), and nondevice (ND) cohorts and followed for a minimum of 12 months. Since it is anticipated that some baseline patient characteristics and risk factors will differ significantly from those reported in predominantly Western populations, event rates will be compared to a propensity-matched population from the MADIT RIT trial. Primary endpoints are composite rates of first appropriately treated ventricular arrhythmias (VA) or/and life-threatening VA symptoms for the ICD and CRT-D cohorts. For nondevice and PA cohorts, the primary outcome is all-cause mortality., Conclusions: The Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan is a large prospective multicenter registry with defined device treatment cohorts and will provide data for risk stratification for cardiovascular events in Japanese HF patients., Competing Interests: Yamasaki H. has no conflict to report. Ando, K. received lecture fees from Japan Lifeline Co., Ltd, Terumo Co., Ltd., Bristol‐Myers Squibb Co., Ltd, Medtronic Japan Co. Ltd., Biotronik Japan, Bayer Co., Ltd. and Boston Scientific Japan. Ikeda, T. received scholarship funds or donations scholarship funds from Medtronic Japan Co., Ltd., Japan Lifeline Co., Ltd., and Daiichi Sankyo Co., Ltd. and remuneration from Ono Pharmaceutical Co., Ltd., Bayer Co., Ltd., and Bristol‐Myers Squibb Co., Ltd.. Mitsuhashi, T. received lecture fees from Medtronic Japan Co., Ltd., and Abbott Japan. Murohara, T. has no conflict of interest. Nishii, N. belonged to the endowed department by Medtronic Japan Co., Ltd. and received the lecture fee from Medtronic Japan Co., Ltd., and Boston Scientific Japan. Nogami, A. received honoraria from Johnson & Johnson, Boehringer‐Ingelheim, Daiichi‐Sankyo Co., Ltd., and Abbott Japan and an endowment from Medtronic Japan Co., Ltd., and DVx Co., Ltd.. Sakata Y. received a scholarship fund granted from Boston Scientific Japan. Shimizu, W. has no conflict of interest. Simon T., Beaudoint C., and Kayser T. are employees at Boston Scientific. Kutyifa, V. received research grants from Boston Scientific, ZOLL, Biotronik, Spire Inc, consultant fees from Biotronik, and ZOLL. Aonuma, K. received speaker honoraria from Abbott Japan, Boehringer‐Ingelheim, Daiichi‐Sankyo Co., Ltd., Boston Scientific Japan and belonged to an endowment department by Abbott Japan., (© 2021 The Authors. Journal of Arrhythmia published by John Wiley & Sons Australia, Ltd on behalf of Japanese Heart Rhythm Society.)

Efforts to reduce insecticide inputs against plum curculio, Conotrachelus nenuphar , a key pest of apples in eastern North America, include perimeter-row insecticide sprays applied after the whole-orchard petal fall spray to manage dispersing adults and, more recently, insecticide sprays confined to odor-baited trap trees. Entomopathogenic nematodes (EPNs) are virulent to ground-dwelling stages of C. nenuphar , and may be applied to the ground underneath trap-tree canopies. Here, we (1) compared the efficacy of the odor-baited trap tree approach with grower-prescribed (=grower standard) sprays to manage C. nenuphar populations over a six-year period in seven commercial apple orchards in New England; and (2) assessed the performance of the EPN Steinernema riobrave at suppressing ground-dwelling stages of C. nenuphar . In addition, the performance of S. riobrave was compared against that of S. carpocapsae and S. feltiae in one year. Across the six years, percent fruit injury on trap tree plots averaged 11.3% on odor-baited trap trees and 1.4% on unbaited trees in grower standard plots, highlighting the ability of trap trees to aggregate C. nenuphar activity and subsequent injury. Mean percentage injury on fruit sampled from interior trees, the strongest measure of treatment performance, in trap tree plots did not differ significantly from that recorded on interior trees in grower standard spray plots (0.95 vs. 0.68%, respectively). Steinernema riobrave consistently reduced C. nenuphar populations as indicated by the significantly lower number of adult C. nenuphar that emerged from the soil, when compared to water control. Steinernema carpocapsae and S. riobrave performed similarly well, and both EPN species outperformed S. feltiae . Our combined findings indicate that an IPM approach that targets multiple life stages of C. nenuphar has the potential to manage this pest more sustainably in a reduced-spray environment.

Gallstone ileus is a rare case of mechanical intestinal obstruction observed in patients with history of cholelithiasis or cholecystitis. Its diagnosis is difficult and it is characterized by high mortality rate. Diagnostic Imaging plays an important role in the management of patients with suspected gallstone ileus because an early diagnosis could reduce the mortality. Abdominal Computed Tomography (CT) is the preferred modality because of its rapid diagnosis. Surgery remains the gold standard treatment.

Aim: To assess the attenuation of non-calcified atherosclerotic coronary artery plaques with computed tomography coronary angiography (CTCA)., Methods: Four hundred consecutive patients underwent CTCA (Group 1: 200 patients, Sensation 64 Cardiac, Siemens; Group 2: 200 patients, VCT GE Healthcare, with either Iomeprol 400 or Iodixanol 320, respectively) for suspected coronary artery disease (CAD). CTCA was performed using standard protocols. Image quality (score 0-3), plaque (within the accessible non-calcified component of each non-calcified/mixed plaque) and coronary lumen attenuation were measured. Data were compared on a per-segment/per-plaque basis. Plaques were classified as fibrous vs lipid rich based on different attenuation thresholds. A P < 0.05 was considered significant., Results: In 468 atherosclerotic plaques in Group 1 and 644 in Group 2, average image quality was 2.96 ± 0.19 in Group 1 and 2.93 ± 0.25 in Group 2 (P ≥ 0.05). Coronary lumen attenuation was 367 ± 85 Hounsfield units (HU) in Group 1 and 327 ± 73 HU in Group 2 (P < 0.05); non-calcified plaque attenuation was 48 ± 23 HU in Group 1 and 39 ± 21 HU in Group 2 (P < 0.05). Overall signal to noise ratio was 15.6 ± 4.7 in Group 1 and 21.2 ± 7.7 in Group 2 (P < 0.01)., Conclusion: Higher intra-vascular attenuation modifies significantly the attenuation of non-calcified coronary plaques. This results in a more difficult characterization between lipid rich vs fibrous type.

Background: Gemcitabine plus capecitabine are active in patients (pts) with advanced pancreatic cancer (APC). Intra-arterial chemotherapy showed activity and low toxicity. Combination of systemic and intra-arterial chemotherapy was investigated., Patients and Methods: Patients with APC, progressed after a first-line chemotherapy, were included. Fixed doses of epirubicin 35 mg/m(2) and cisplatin 42 mg/m(2) intra-arterially every 28 days, and capecitabine 650 mg/m(2) twice a day on days 2-15; gemcitabine systemically in increasing doses on day 2. The purpose was to find maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT)., Results: Fifteen patients were enrolled. DLT occurred at 1300 mg/m(2) of gemcitabine and consisted of myelotoxicity (grade 4 febrile neutropenia and grade 4 thrombocytopenia)., Conclusion: Limiting toxicity was hematological. For further studies intra-arterial epirubicin 35 mg/m(2) and cisplatin 42 mg/m(2); systemic gemcitabine at 1,000 mg/m(2) on day 2, and capecitabine at 650 mg/m(2) twice a day PO on days 2-15 are suggested.

Unlabelled: The aim of the present study was to evaluate the activity of hepatic intra-arterial infusion of epirubicin and cisplatin combined with oral capecitabine, in patients with unresectable biliary carcinomas., Patients and Methods: Twenty patients were treated by bolus infusion of epirubicin 50 mg/m2 and cisplatin 60 mg/m2 in the hepatic artery on day 1, combined with oral capecitabine 1000 mg/m2 bid, from day 2 to day 15., Results: Partial responses (PR) were observed in 6 patients (31.5%), stable disease (SD) in 9 (47.5%) and progression (PD) in 4 (21%). The median progression-free and overall survival periods were 11.6 and 18.0 months, respectively, and 1-year survival was 74%. One patient died after the first cycle because of G4 diarrhea. The other patients had good tolerance, with minimal hematological toxicity and only 1 G3 vomiting., Conclusion: This combined intra-arterial and oral approach to patients with biliary carcinomas was found to be active and safe and seems to produce an encouraging survival response.

Background: Hepatic arterial chemotherapy (HAC) is an effective treatment of liver metastases from colorectal cancer (CRC). Phase I and II studies have already shown the feasibility and efficacy of intra-arterial oxaliplatin (OXA)., Patients and Methods: Twenty-one pre-treated patients with liver metastases who received HAC with OXA/folinic acid (FA)/5-fluorouracil (5-FU) at our Division between March 2000 and November 2003, were clinically examined. Most patients were heavily pre-treated with two or more systemic chemotherapeutic regimes. All patients received a percutaneously implanted catheter into the hepatic artery through femoral or transaxillary access. Treatment was administered every 14 days: OXA 100 mg/m2 as a 12-hour infusion on day 1; FA 100 mg/m2 as a 2-hour infusion on days 2 and 3; 5-FU 2600 mg/m2 as a continuous infusion on days 2 and 3., Results: Grade 3-4 toxicities were: asthenia (2 out of 21), transaminase elevation (2 out of 21) and pain (2 out of 21), nausea and vomiting (1 out of 21), neutropenia (1 out of 21), thrombocytopenia (1 out of 21) and neurotoxicity (1 out of 21). Main dose limiting toxicity was right upper quadrant pain. Response rates were: 5% complete response, 19% partial response, 28% stable disease and 48% progressive disease. Two patients became operable and underwent complete resection of liver disease. The median overall survival was 36.1 months. Two-year and 3-year survival rates were 62% and 52%, respectively., Conclusion: This regimen is feasible with low toxicity and with an encouraging overall tumor growth control (52%) in a subset of heavily pre-treated patients. Intra-arterial OXA/FA/5-FU should be considered for the treatment of patients pre-treated with systemic chemotherapies with liver metastases from CRC.

Background: Low birth weight remains the primary cause of neonatal morbidity and mortality in the United States. We examined whether maternal happiness about a pregnancy, in addition to her report of the father's happiness, predicts birth weight and risk for low birth weight (<2,500 g)., Methods: In this prospective cohort study, the mother's report of her and her partner's happiness about the pregnancy was measured before 21 weeks' gestation on a scale from 1 to 10 (1 to 3 unhappy, 4 to 7 ambivalent, or 8 to 10 happy). "Mother reports partner happier" occurred when the mother perceived the father's happiness score at least 5 points greater than her own. Information on birth weights and maternal sociodemographic, medical, and psychosocial factors were obtained from surveys and medical records., Results: Of 162 live births, 9 were low birth weight (5.6%). Compared with women who reported happiness with the pregnancy, risk for low birth weight was greater when the mother reported partner happier about the pregnancy (relative risk 10.0, 95% confidence interval, 3.1-32.4). This predictor of birth weight remained significant in multivariate linear regression analyses (coefficient = -472 g, SE = 171 g, P = .007) after adjustment for other known predictors of birth weight., Conclusions: Maternal report of greater partner happiness about a pregnancy is associated with birth weight and appears to define low- and high-risk subgroups for low birth weight in a low-income population. Further study in larger samples is needed to confirm our findings and to assess whether maternal report of greater partner happiness is itself a modifiable factor or is a marker for other factors that might be modified with targeted interventions.

Unlabelled: No study has evaluated the efficacy of ropivacaine in peribulbar block for ophthalmic surgery. The purpose of this prospective, randomized, double-blinded study was to compare ropivacaine and a lidocaine-bupivacaine mixture in peribulbar anesthesia. Sixty ASA physical status I or II patients scheduled for elective vitreoretinal surgery were randomized to receive a peribulbar block with 8 mL of either 0.75% ropivacaine (ropivacaine group, n = 30) or a 1:1 mixture of 2% plain lidocaine and 0.5% plain bupivacaine (lido-bupivacaine group, n = 30). Time required for onset of surgical anesthesia, quality of postoperative analgesia, incidence of side effects, and analgesic consumption were recorded. Surgical block was achieved after 8 +/- 5 min in the lido-bupivacaine group and after 10 +/- 5 min in the ropivacaine group (P = 0.23). A 3-mL supplemental injection 15 min after block placement was required in 6 patients in the lido-bupivacaine group (20%) and in 10 patients in the ropivacaine group (33%) due to inadequate motor block (P = 0.38). On Postoperative Day 1, 26 patients in the ropivacaine group (87%) reported no pain at the verbal rating score, compared with 18 patients in the lido-bupivacaine group (60%) (P = 0.005). We conclude that 0.75% ropivacaine may be a suitable choice when performing peribulbar anesthesia for vitreoretinal surgery., Implications: Quick onset of block with prolonged postoperative analgesia is an important goal in regional anesthesia for ophthalmic surgery. Evaluating clinical properties of 0.75% ropivacaine and a 1:1 mixture of 2% lidocaine and 0.5% bupivacaine for peribulbar anesthesia, we demonstrated that ropivacaine has an onset similar to that of the lidocaine-bupivacaine mixture and provides a better quality of postoperative analgesia.