A mutually communicable external system resource in remote monitoring for cardiovascular implantable electronic devices.

BACKGROUND: Using third-party resources to manage remote monitoring (RM) data from implantable cardiac electronic devices (CIEDs) can assist in device clinic workflows. However, each hospital-acquired data is not used for further analysis as big data. METHODS AND RESULTS: We developed a real-time and automatically centralized system of CIED information from multiple hospitals. If the extensive data-based analysis suggests individual problems, it can be returned to each hospital. To show its feasibility, we prospectively analyzed data from six hospitals. For example, unexpected abnormal battery levels were easily illustrated without recall information. CONCLUSIONS: The centralized RM system could be a new platform that promotes the utilization of device data as big data, and that information could be used for each patient's practice.

Quality Indicators in Patient Referral Documents for Heart Failure in Japan.

This study examined quality indicators (QIs) for heart failure (HF) in patients' referral documents (PRDs).We conducted a nationwide questionnaire survey to identify information that general practitioners (GPs) would like hospital cardiologists (HCs) to include in PRDs and that HCs actually include in PRDs. The percentage of GPs that desired each item included in PRDs was converted into a deviation score, and items with a deviation score of ≥ 50 were defined as QIs. We rated the quality of PRDs provided by HCs based on QI assessment.We received 281 responses from HCs and 145 responses from GPs. The following were identified as QIs: 1) HF cause; 2) B-type natriuretic peptide (BNP) or N-terminal pro-BNP concentration; 3) left ventricular ejection fraction or echocardiography; 4) body weight; 5) education of patients and their families on HF; 6) physical function, and 7) functions of daily living. Based on QI assessment, only 21.7% of HCs included all seven items in their PRDs. HCs specializing in HF and institutions with many full-time HCs were independently associated with including the seven items in PRDs.The quality of PRDs for HF varies among physicians and hospitals, and standardization is needed based on QI assessment.

Differences in Priorities for Heart Failure Management Between Cardiologists and General Practitioners in Japan.

BACKGROUND: The purpose of this study was to clarify the current status and issues of community collaboration in heart failure (HF) using a nationwide questionnaire survey.Methods and Results:We conducted a survey among hospital cardiologists and general practitioners (GPs) using a web-based questionnaire developed with the Delphi method, to assess the quality of community collaboration in HF. We received responses from 46 of the 47 prefectures in Japan, including from 281 hospital cardiologists and 145 GPs. The survey included the following characteristics and issues regarding community collaboration. (1) Hospital cardiologists prioritized medical intervention for preventing HF hospitalization and death whereas GPs prioritized supporting the daily living of patients and their families. (2) Hospital cardiologists have not provided information that meets the needs of GPs, and few regions have a community-based system that allows for the sharing of information about patients with HF. (3) In the transition to home care, there are few opportunities for direct communication between hospitals and community staff, and consultation systems are not well developed. CONCLUSIONS: The current study clarified the real-world status and issues of community collaboration for HF in Japan, especially the differences in priorities for HF management between hospital cardiologists and GPs. Our data will contribute to the future direction and promotion of community collaboration in HF management.

Consensus Report on Destination Therapy in Japan　- From the DT Committee of the Council for Clinical Use of Ventricular Assist Device Related Academic Societies.

Destination therapy (DT) is the indication to implant a left ventricular assist device (LVAD) in a patient with stage D heart failure who is not a candidate for heart transplantation. The implantable LVAD has been utilized in Japan since 2011 under the indication of bridge to transplant (BTT). After almost 10 year lag, DT has finally been approved and reimbursed in May 2021 in Japan. To initiate the DT program in Japan, revision of the LVAD indication from BTT is necessary. Also, in-depth discussion of caregiver issues as well as end-of-life care is indispensable. For that purpose, we assembled a DT committee of multidisciplinary members in August 2020, and started monthly discussions via web-based communication during the COVID-19 pandemic. This is a summary of the consensus reached after 6 months' discussion, and we have included as many relevant topics as possible. Clinical application of DT has just started, and we are willing to revise this consensus to meet the forthcoming issues raised during real-world clinical experience.

Possible associations between palliative care conferences and positive outcomes when performing palliative care for patients with end-stage heart failure: a nationwide cross-sectional questionnaire survey.

Palliative care for end-stage heart failure should be provided by a multidisciplinary team. However, the influence of each occupational category on patients receiving palliative care for end-stage heart failure remains unclear. Thus, this study investigated the relationships between palliative care conferences and positive outcomes of palliative care for end-stage heart failure patients. We sent questionnaires to all cardiology training hospitals authorized by the Japanese Circulation Society (n = 1004); of these, responses from the directors at 554 institutions were analyzed. We divided the responding institutions into two groups according to their implementation of palliative care conferences for patients with end-stage heart failure. The institutions that had held such conferences (n = 223) had a larger number of hospital beds, beds in the cardiovascular department, and patients admitted to the cardiovascular department, compared with institutions that had not held these conferences (n = 321). The usage rates of opioids, non-steroidal anti-inflammatory drugs, and sedatives were significantly higher in institutions that held these conferences. Multivariate analysis revealed that nutritionists and medical social workers had greater involvement in the improvement of mental symptoms and ensuring that patients could stay where they wished, respectively. The presence of palliative care physicians, physical therapists, or pharmacists was associated with multiple positive outcomes. This study indicated that there are possible associations between palliative care conferences and positive outcomes when performing palliative care for patients with end-stage heart failure.

Nationwide Survey of Palliative Care for Patients With Heart Failure in Japan.

BACKGROUND: Palliative care for heart failure (HF) patients is recommended in Western guidelines, so this study aimed to clarify the current status of palliative care for HF patients in Japan.Methods and Results:A survey was sent to all Japanese Circulation Society-authorized cardiology training hospitals (n=1,004) in August 2016. A total of 544 institutions (54%) returned the questionnaire. Of them, 527 (98%) answered that palliative care is necessary for patients with HF. A total of 227 (42%) institutions held a palliative care conference for patients with HF, and 79% of the institutions had <10 cases per year. Drug therapy as palliative care was administered at 403 (76%) institutions; morphine (87%) was most frequently used. Among sedatives, dexmedetomidine (33%) was administered more often than midazolam (29%) or propofol (20%). Regarding the timing of end-of-life care, most institutions (84%) reported having considered palliative care when a patient reached the terminal stage of HF. Most frequently, the reason for the decision at the terminal stage was "difficulty in discontinuing cardiotonics." A major impediment to the delivery of palliative care was "difficulty predicting an accurate prognosis." CONCLUSIONS: This large-scale survey showed the characteristics of palliative care for HF in Japan. The present findings may aid in the development of effective end-of-life care systems.

Impact of myocardial reperfusion status on QT dispersion after successful recanalization of the infarct-related artery in acute myocardial infarction.

OBJECTIVE: To determine whether adequate myocardial perfusion status after transluminal recanalization is associated with prompt improvement of QT dispersion (QTd). BACKGROUND: Transluminal recanalization of the infarct-related coronary artery in acute myocardial infarction aims to promptly restore myocardial perfusion, to maximize electrical and mechanical recovery. QTd represents the heterogeneity of ventricular repolarization, which may affect electrical stability. METHODS: Forty patients who underwent primary percutaneous coronary intervention for their first anterior acute ST-elevation myocardial infarction were prospectively enrolled. Myocardial reperfusion status was assessed by myocardial blush grade (MBG) on the final angiogram after successful recanalization (Thrombolysis In Myocardial Infarction Grade 3 flow). RESULTS: Preprocedural QTd was similar in patients with final MBG 0-1, 2, and 3 (76 ± 24, 67 ± 13, and 69 ± 13 milliseconds, respectively; P = 0.661). After recanalization, QTd decreased in patients with MBG 3 (39 ± 16 milliseconds, P < 0.001) but not in patients with MBG 0-1 (74 ± 20 milliseconds) or MBG 2 (82 ± 16 milliseconds). Multivariate analysis showed that postprocedural MBG was an independent predictor of QTd after recanalization (standardized regression coefficient = -0.628, P < 0.001). CONCLUSIONS: Adequate tissue perfusion may be crucial for electrical stability of the myocardium after reperfusion.

Differing effects of obstructive and central sleep apneas on stroke volume in patients with heart failure.

RATIONALE: Obstructive sleep apnea and central sleep apnea increase risk of mortality in patients with heart failure (HF), possibly because of hemodynamic compromise during sleep. However, beat-to-beat stroke volume (SV) has not been assessed in response to obstructive and central events during sleep in patients with HF. Because obstructive events generate negative intrathoracic pressure that reduces left ventricular (LV) preload and increases afterload, but central events do not, obstructive events should lead to greater hemodynamic compromise than central events. OBJECTIVES: To determine the effects of obstructive and central apneas and hypopneas during sleep on SV in patients with HF. METHODS: Patients with systolic HF (LV ejection fraction ≤ 45%) and sleep apnea underwent beat-to-beat measurement of SV by digital photoplethysmography during polysomnography. Change in SV from before to the end of obstructive and central respiratory events was calculated and compared between these types of events. MEASUREMENTS AND MAIN RESULTS: Changes in SV were assessed during 252 obstructive and 148 central respiratory events in 40 patients with HF. Whereas SV decreased by 6.8 (±8.7)% during obstructive events, it increased by 2.6 (±5.4)% during central events (P < 0.001 for difference). For obstructive events, reduction in SV was associated independently with LV ejection fraction, duration of respiratory events, and degree of oxygen desaturation. CONCLUSIONS: In patients with HF, obstructive and central respiratory events have opposite hemodynamic effects: whereas obstructive sleep apnea appears to have an adverse effect on SV, central sleep apnea appears to have little or slightly positive effects on SV. These observations may have implications for therapeutic approaches to these two breathing disturbances.

Clinical features and outcome in hospitalized heart failure in Japan (from the ATTEND Registry).

BACKGROUND: Hospitalized heart failure (HHF) is a critical issue in Japan. To improve its management and outcomes, the clinical features, in-hospital management, and outcomes should be analyzed to improve the guidelines for HHF. METHODS AND RESULTS: The acute decompensated heart failure syndromes (ATTEND) registry is the largest study of HHF in Japan. The present report covers the clinical features and in-hospital management of HHF patients. The data from 4,842 enrolled patients have demonstrated that most Japanese HHF patients are elderly, with new onset, and a history of hypertension and orthopnea on admission. During hospitalization, furosemide and carperitide were commonly used and the length of stay was extremely long (mean 30 days), with 6.4% in-hospital mortality. CONCLUSIONS: The findings of the present study suggest the following: (1) the focus for hypertensive elderly and diabetic patients should be on primary prevention of HHF,(2) more intensive management with noninvasive positive pressure ventilation should be performed at the urgent stage, (3) it is necessary to clarify the clinical benefit of carperitide and angiotensin-receptor blockers, because they are commonly used in Japan, and (4) it is necessary to clarify the relationship between in-hospital mortality and length of stay from the viewpoint of both outcome and cost of patient care.

Differences in hemodynamic responses between intravenous carperitide and nicorandil in patients with acute heart failure syndromes.

While recent guidelines for the treatment of acute heart failure syndromes (AHFS) recommend pharmacotherapy with vasodilators in patients without excessively low blood pressure (BP), few reports have compared the relative efficiency of vasodilators on hemodynamics in AHFS patients. The present study aimed to assess the differences in hemodynamic responses between intravenous carperitide and nicorandil in patients with AHFS. Thirty-eight consecutive patients were assigned to receive 48-h continuous infusion of carperitide (n = 19; 0.0125-0.05 µg/kg/min) or nicorandil (n = 19; 0.05-0.2 mg/kg/h). Hemodynamic parameters were estimated at baseline, and 2, 24, and 48 h after drug administration using echocardiography. After 48 h of infusion, systolic BP was significantly more decreased in the carperitide group compared with that in the nicorandil group (22.1 ± 20.0 % vs 5.3 ± 10.4 %, P = 0.003). While both carperitide and nicorandil significantly improved hemodynamic parameters, improvement of estimated pulmonary capillary wedge pressure was greater in the carperitide group (38.2 ± 14.5 % vs 26.5 ± 18.3 %, P = 0.036), and improvement of estimated cardiac output was superior in the nicorandil group (52.1 ± 33.5 % vs 11.4 ± 36.9 %, P = 0.001). Urine output for 48 h was greater in the carperitide group, but not to a statistically significant degree (4203 ± 1542 vs 3627 ± 1074 ml, P = 0.189). Carperitide and nicorandil were differentially effective in improving hemodynamics in AHFS patients. This knowledge may enable physicians in emergency wards to treat and manage patients with AHFS more effectively and safely.

Nocturnal rostral fluid shift: a unifying concept for the pathogenesis of obstructive and central sleep apnea in men with heart failure.

BACKGROUND: Obstructive sleep apnea (OSA) and central sleep apnea are common in patients with heart failure. We hypothesized that in such patients, severity of OSA is related to overnight rostral leg fluid displacement and increase in neck circumference, severity of central sleep apnea is related to overnight rostral fluid displacement and to sleep Pco(2), and continuous positive airway pressure alleviates OSA in association with prevention of fluid accumulation in the neck. METHODS AND RESULTS: In 57 patients with heart failure (ejection fraction or=50% of apneas and hypopneas obstructive) and a central-dominant group (>50% of events central). Patients with OSA received continuous positive airway pressure. In obstructive-dominant patients, there were inverse relationships between overnight change in leg fluid volume and both the overnight change in neck circumference (r=-0.780, P<0.001) and the apnea-hypopnea index (r=-0.881, P<0.001) but not transcutaneous Pco(2). In central-dominant patients, the overnight reduction in leg fluid volume correlated inversely with the apnea-hypopnea index (r=-0.919, P<0.001) and the overnight change in neck circumference (r=-0.568, P=0.013) and directly with transcutaneous Pco(2) (r=0.569, P=0.009). Continuous positive airway pressure alleviated OSA in association with prevention of the overnight increase in neck circumference (P<0.001). CONCLUSIONS: Our findings suggest that nocturnal rostral fluid shift is a unifying concept contributing to the pathogenesis of both OSA and central sleep apnea in patients with heart failure.

Appropriateness rating for the application of optimal medical therapy and multidisciplinary care among heart failure patients.

AIMS: Clinical guidelines for improving the patients' quality of care vary in clinical practice, particularly in super-aging societies, like in Japan. We aimed to develop a set of appropriate-use criteria (AUC) for contemporary heart failure (HF) management to assist physicians in decision making. METHODS AND RESULTS: With the use of the RAND methodology, a multidisciplinary writing group developed patient-based clinical scenarios in 10 selected key topics, stratified mainly by HF stage, age, and renal function. Nine nationally recognized expert panellists independently rated the clinical scenario appropriateness twice on a scale of 1-9, as 'appropriate' (7-9), 'may be appropriate' (4-6), or 'rarely appropriate' (1-3). Decisions were based on clinical evidence and professional opinions in the context of available resource use and costs. An interactive round-table discussion was held between the first and second ratings; the median score of the nine experts was then assigned to an appropriate-use category. Most clinical scenarios without strong evidence were evaluated as 'may be appropriate'. Frailty assessments in elderly patients (age ≥ 75 years), regardless of the HF stage, and advanced care planning in patients with stage C/D HF, regardless of age, were considered 'appropriate'. For HF with reduced ejection fraction, beta-blocker administration in elderly patients (age ≥ 75 years) with heart rate < 50 b.p.m. and mineral corticosteroid receptor antagonist use in elderly patients (age ≥ 75 years) with an estimated glomerular filtration rate < 30 mL/min/1.73 m2 were considered 'rarely appropriate'. CONCLUSIONS: The HF management AUC provide a practical guide for physicians regarding scenarios commonly encountered in daily practice.

Acute decompensated heart failure syndromes (ATTEND) registry. A prospective observational multicenter cohort study: rationale, design, and preliminary data.

Acute heart failure syndromes (AHFS) are likely to increase in the future, and the high readmission rate of patients with AHFS is an important issue in Western countries. However, there are very few published epidemiological studies on AHFS in the Asia Pacific region. Because AHFS are heterogeneous, the characteristics, clinical profile, and management of AHFS should be clarified in an epidemiological study. The acute decompensated heart failure syndromes (ATTEND) registry is a prospective, observational, multicenter cohort study being performed in Japan and is the first epidemiological study of AHFS in the Asia Pacific region. This study is designed to investigate several aspects of AHFS as follows: (1) the registry allows patient-based data collection for precise evaluation of patient characteristics and short-term outcomes, including the readmission rate; (2) confirmation of clinical assessments can be performed, and new clinical assessments can be created; and (3) feedback allows the modification of guidelines for clinical management. The present report describes the clinical characteristics of patients with AHFS in Japan based on the preliminary data collected in this study, and the similarities and differences in characteristics of these patients compared with those in Western countries. Although most of the patient characteristics did not differ from those reported in Western studies, there are some unique findings in this study, including a high rate of treatment with carperitide (69.4%) and angiotensin II receptor blockers (53.9%) at discharge and a longer hospital stay (median 21 days). The ATTEND registry is designed to provide valuable information to clarify the characteristics of patients with AHFS to improve their management.

Relationship between overnight rostral fluid shift and Obstructive Sleep Apnea in nonobese men.

RATIONALE: The cause of increased pharyngeal collapsibility in patients with obstructive sleep apnea is incompletely understood. In awake healthy subjects, we showed that fluid displacement from the legs into the neck induced by lower body positive pressure reduces upper airway size and increases its collapsibility. Prolonged sitting leads to dependent fluid accumulation in the legs. OBJECTIVES: To test the hypotheses that the apnea-hypopnea index (AHI) during sleep will be related to the amount of fluid spontaneously displaced from the legs overnight, and that this will, in turn, be related to the time spent sitting the previous day. METHODS: In 23 nonobese healthy men referred for sleep studies for suspected obstructive sleep apnea, we assessed the changes in leg fluid volume and in neck circumference from the beginning to the end of the night, and the time spent sitting during the previous day. MEASUREMENTS AND MAIN RESULTS: The overnight change in leg fluid volume correlated strongly with the AHI (r = -0.773, P < 0.001), the change in neck circumference (r = -0.792, P < 0.001), and the time spent sitting (r = -0.588, P = 0.003). Multivariate analysis showed that the only significant independent correlates of the AHI were the overnight changes in leg fluid volume and neck circumference, which together explained 68% of the variability in the AHI among subjects. CONCLUSIONS: These novel findings suggest that overnight rostral fluid displacement from the legs, related to prolonged sitting, may play a previously unrecognized role in the pathogenesis of obstructive sleep apnea in nonobese men that is independent of body weight.

Inverse relationship of subjective daytime sleepiness to mortality in heart failure patients with sleep apnoea.

AIMS: Patients with sleep apnoea (SA) and heart failure (HF) are less sleepy than SA patients without HF. HF and SA both increase sympathetic nervous system activity (SNA). SNA can augment alertness. We previously showed that in HF patients, the degree of daytime sleepiness was not related to the severity of SA but was inversely related to SNA. Elevated SNA is associated with increased mortality in HF. Therefore, we hypothesized that in HF patients with SA, the degree of daytime sleepiness will be inversely related to mortality. METHODS AND RESULTS: In a prospective cohort study, 218 consecutive patients with systolic HF had overnight polysomnography. Among them, 80 subjects with SA (apnoea-hypopnoea index ≥15) were followed for a mean of 28 months to determine all-cause mortality rate. Subjective daytime sleepiness was assessed by the Epworth Sleepiness Scale (ESS). During follow-up, 20 patients died. The 5 year death rate in patients with ESS less than 6 (i.e. less sleepy) was significantly higher than in patients with an ESS at or above the median of 6 (i.e. sleepier) [21.3 deaths/100 patient-years vs. 6.2 deaths/100 patient-years, unadjusted hazard ratio (HR) 2.94, 95% confidence interval (CI) 1.20 to 7.20, P = 0.018]. After adjusting for confounding factors that included sex, history of hypertension, and mean arterial oxyhaemoglobin saturation, compared with the sleepier patients, less sleepy patients had greater risk of mortality (HR 2.56, 95% CI 1.01 to 6.47, P = 0.047). As a continuous variable, ESS scores were inversely related to mortality risk (HR 0.86, 95% CI 0.75 to 0.98, P = 0.022). CONCLUSIONS: In patients with HF and SA, the degree of subjective daytime sleepiness is inversely related to the mortality risk, suggesting that among HF patients with SA, those with the least daytime sleepiness are at greater risk of death. They may therefore have greater potential for mortality benefit from therapy of SA than those with greater daytime sleepiness.

Prevalence and physiological predictors of sleep apnea in patients with heart failure and systolic dysfunction.

BACKGROUND: Previous studies reported high prevalences of obstructive and central sleep apnea (OSA and CSA, respectively) in patients with heart failure (HF). However, these preceded widespread use of beta-blockers and spironolactone that might have reduced their prevalences. We therefore determined, in patients with HF, prevalences and predictors of OSA and CSA and the influence of changes in HF therapy on prevalences. METHODS AND RESULTS: A total of 218 HF patients with left ventricular ejection fraction (LVEF) or=15 hours of sleep, either OSA or CSA), or mild to no sleep apnea. The prevalence of moderate to severe OSA was 26% and of CSA was 21%. Predictors of OSA were older age, male sex, and greater body mass index, and of CSA were older age, male sex, atrial fibrillation, hypocapnia, and diuretic use. Between 1997 and 2004, the prevalences of OSA and CSA did not change significantly (P(trend) =.460, P(trend) =.211, respectively) despite increased use of beta-blockers and spironolactone (P(trend) < .001, P(trend) < .001, respectively), and an increase in LVEF (P(trend)=.005). CONCLUSIONS: OSA and CSA remain common in patients with HF, despite increases in beta-blocker and spironolactone use.

Difference in upper airway collapsibility during wakefulness between men and women in response to lower-body positive pressure.

Fluid shift from the legs to the neck induced by LBPP (lower-body positive pressure) increases UA (upper airway) collapsibility in healthy men. Rostral fluid displacement during recumbency may therefore contribute to the pathogenesis of OSA (obstructive sleep apnoea). There is a higher prevalence of OSA in men than in women. We therefore hypothesized that UA collapsibility increases more in men in response to rostral fluid displacement than in women. UA collapsibility was assessed in healthy, non-obese men and women while awake by determining UA Pcrit (critical closing pressure) during application of different suction pressures to the UA. Subjects were randomized to 5 min control or LBPP arms after which they crossed-over into the other arm following a 30 min washout. LBPP was applied by inflating anti-shock trousers wrapped around both legs to 40 mmHg. Pcrit, leg fluid volume and neck circumference were measured at baseline and after 5 min of both control and LBPP periods. LBPP caused a decrease in leg fluid volume and an increase in neck circumference that did not differ between men and women. However, compared with the control period, LBPP induced a much greater increase in Pcrit in men than in women (7.2+/-1.8 compared with 2.0+/-1.5 cm H2O, P=0.035). We conclude that rostral fluid displacement by LBPP increases UA collapsibility more in healthy, non-obese men than in women. This may be one mechanism contributing to the higher prevalence of OSA in men than in women.