scholarly journals Real world experience with heart failure risk status generated by cardiac resynchronisation therapy defibrillators: high heart failure risk status incidence, causes and timing of remote transmissions

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Debski ◽  
L Howard ◽  
P Black ◽  
A Goode ◽  
C Cassidy ◽  
...  

Abstract Background Proactive patient monitoring is of paramount importance in effective management of heart failure (HF) patients. Cardiac implantable electronic devices (CIEDs) used in HF patients are able to derive long-term trends in physiologic parameters and provide timely warning to clinicians. Little is known, however, on the real-world experience with device-generated HF risk-stratifying algorithms. Purpose Heart Failure Risk Score (HFRS) takes into account nine parameters and is calculated automatically based on long-term clinical trends. Remote transmissions provide information on the risk of HF event in next 30 days categorized as low, medium or high based on a maximum daily risk status in prior 30 days. We aimed to evaluate the ability of HFRS to alert HF specialists on the actual HF risk status. Methods The prospective registry included all patients with CIEDs featuring integrated Heart Failure Risk Score (HFRS) followed via Medtronic CareLink remote monitoring system and enabled for Co-management (CM) from May 2015 to August 2019 in a tertiary centre. High HFRS does not trigger automatic alert transmission. Study follow-up spanned between start of CM and last transmission in 2019. Inclusion criteria were CRT-D in situ, active Home Monitor, switched on OptiVol 2.0 remote alert and transmission data available on CareLink following study period completion. Transmissions were scheduled 3-monthly. Results Out of 229 consecutive patients, 132 met study criteria. Mean age was 74±10 years, 18% were female. Median follow-up duration was 2.7 years (IQR 1.3). Total number of transmissions was 2652, median per patient was 18 (IQR 13); scheduled, unscheduled and care alerts constituted 42%, 44% and 14%, respectively. One third of transmissions were automatically sent for CM review. There were 398 high HFRS episodes. OptiVol fluid index was below the threshold throughout 128 (32%) episodes. Missed episodes (not transmitted within 30 days from the final day of high HFRS) amounted to 130 (33%) and the reasons behind this included OptiVol alerting before the first day of high HFRS or persistently elevated when HFRS changed from low/medium to high (52%), low OptiVol index during the episode (38%) or other (10%). Median duration of high HFRS was 7 days (IQR 12, range, 1–187). Among timely picked-up high HFRS episodes, 38% were transmitted during the relevant episode and 62% afterwards with median delay of 10 days (IQR 15) from the last day of high HFRS; 21% of transmissions showing high HFRS were not highlighted for CM review which correlated with low OptiVol index, P<0.001. The factors contributing to high HFRS included: raised OptiVol (60%), patient activity (83%), AT/AF (46%), ventricular rate (VR) during AF (6%), % of VP (40%), shocks (2%), treated VT/VF (2%), night VR (72%) and HR variability (34%). Conclusions In a real-world clinical setting high HFRS was frequently under-reported. The investigation into clinical implications is warranted. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Our department has benefited from unrestricted grants from Boston Scientific and Medtronic Inc during the last 5 years.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Koehler ◽  
E Ippolito ◽  
E.N Warman ◽  
S Sarkar

Abstract Background Diagnostic parameters measured in implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRTD) have been shown to change before and after heart failure (HF) events with fluid overload. Purpose We investigated the temporal characteristics of an integrated diagnostic risk score before and after HF events in a large real-world cohort of patients with ICD/CRTD devices. Methods We linked a de-identified database of aggregated electronic health record (EHR) data (2007–2017) to a manufacturer's device database with continuous diagnostic monitoring data. Patients with ICD/CRTD implants with intra-thoracic impedance diagnostic feature were included for this study. The previously defined integrated diagnostic risk score was derived by combining daily diagnostic data, including intra-thoracic impedance, night-time heart rate, activity, heart rate variability, and atrial fibrillation (AF) burden, ventricular rate during AF, CRT pacing, ventricular tachycardia episodes and shocks, in a Bayesian Belief Network framework. HF event was defined as an inpatient, emergency department, or observation unit stay in a hospital with primary diagnosis of HF and intravenous diuretic administration. Temporal average of daily risk score across all patients in the 60 days pre and post HF events were compared in HF events with and without readmission within 60 days and with no HF event during pre and post follow-up days. Results A total of 17,886 patients with 1.8±1.2 years of follow-up met inclusion criteria. The average age of patients was 66.6±12.3 years, with 72% being males, and 51% with ICD devices. The average integrated diagnostics risk score in HF events with and without readmission and with no events is shown in Figure. A total of 1174 patients had 1425 HF events with no readmission for HF within 60 days and 282 patients had 295 HF events which were followed by readmission for HF within 60 days. A total of 17,839 patients had no HF events over 86,858 follow-up months. The average daily risk score across all patients was higher on all 60 days pre and post HF event with readmission compared to HF events with no readmission (p<0.001) and both were higher compared to follow-up period with no events (p<0.001). The risk score recovers less often after HF events which are followed by readmission within 60 days compared to HF events with no readmission. Conclusions In a large real-world population of patients with ICD/CRTD devices, the average integrated diagnostics risk score was higher before and after HF events with readmission compared to HF events with no readmission. Re-admissions are more likely in patients with smaller risk score recovery after HF events. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic Plc


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P Huang ◽  
C Liu

Abstract Background Lower systolic blood pressure (SBP) at admission or discharge was associated with poor outcomes in patients with heart failure and preserved ejection fraction (HFpEF). However, the optimal long-term SBP for HFpEF was less clear. Purpose To examine the association of long-term SBP and all-cause mortality among patients with HFpEF. Methods We analyzed participants from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) study. Participants had at least two SBP measurements of different times during the follow-up were included. Long-term SBP was defined as the average of all SBP measurements during the follow-up. We stratified participants into four groups according to long-term SBP: <120mmHg, ≥120mmHg and <130mmHg, ≥130mmHg and <140mmHg, ≥140mmHg. Multivariable adjusted Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CI) for all-cause mortality associated with SBP level. To assess for nonlinearity, we fitted restricted cubic spline models of long-term SBP. Sensitivity analyses were conducted by confining participants with history of hypertension or those with left ventricular ejection fraction≥50%. Results The 3338 participants had a mean (SD) age of 68.5 (9.6) years; 51.4% were women, and 89.3% were White. The median long-term SBP was 127.3 mmHg (IQR 121–134.2, range 77–180.7). Patients in the SBP of <120mmHg group were older age, less often female, less often current smoker, had higher estimated glomerular filtration rate, less often had history of hypertension, and more often had chronic obstructive pulmonary disease and atrial fibrillation. After multivariable adjustment, long-term SBP of 120–130mmHg and 130–140mmHg was associated with a lower risk of mortality during a mean follow-up of 3.3 years (HR 0.65, 95% CI: 0.49–0.85, P=0.001; HR 0.66, 95% CI 0.50–0.88, P=0.004, respectively); long-term SBP of <120mmHg had similar risk of mortality (HR 1.03, 95% CI: 0.78–1.36, P=0.836), compared with long-term SBP of ≥140mmHg. Findings from restricted cubic spline analysis demonstrate that there was J-shaped association between long-term SBP and all-cause mortality (P=0.02). These association was essentially unchanged in sensitivity analysis. Conclusions Among patients with HFpEF, long-term SBP showed a J-shaped pattern with all-cause mortality and a range of 120–140 mmHg was significantly associated with better outcomes. Future randomized controlled trials need to evaluate optimal long-term SBP goal in patients with HFpEF. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): China Postdoctoral Science Foundation Grant (2019M660229 and 2019TQ0380)


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S.L Xu ◽  
J Luo ◽  
H.Q Li ◽  
Z.Q Li ◽  
B.X Liu ◽  
...  

Abstract Background New-onset atrial fibrillation (NOAF) complicating acute myocardial infarction (AMI) has been associated with poor survival, but the clinical implication of NOAF on subsequent heart failure (HF) is still not well studied. We aimed to investigate the relationship between NOAF following AMI and HF hospitalization. Methods This retrospective cohort study was conducted between February 2014 and March 2018, using data from the New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction in ShangHai registry, where all participants did not have a documented AF history. Patients with AMI who discharged alive and had complete echocardiography and follow-up data were analyzed. The primary outcome was HF hospitalization, which was defined as a minimum of an overnight hospital stay of a participant who presented with symptoms and signs of HF or received intravenous diuretics. Results A total of 2075 patients were included, of whom 228 developed NOAF during the index AMI hospitalization. During up to 5 years of follow-up (median: 2.7 years), 205 patients (9.9%) experienced HF hospitalization and 220 patients (10.6%) died. The incidence rate of HF hospitalization among patients with NOAF was 18.4% per year compared with 2.8% per year for those with sinus rhythm. After adjustment for confounders, NOAF was significantly associated with HF hospitalization (hazard ratio [HR]: 3.14, 95% confidence interval [CI]: 2.30–4.28; p<0.001). Consistent result was observed after accounting for the competing risk of all-cause death (subdistribution HR: 3.06, 95% CI: 2.18–4.30; p<0.001) or performing a propensity score adjusted multivariable model (HR: 3.28, 95% CI: 2.39–4.50; p<0.001). Furthermore, the risk of HF hospitalization was significantly higher in patients with persistent NOAF (HR: 5.81; 95% CI: 3.59–9.41) compared with that in those with transient NOAF (HR: 2.61; 95% CI: 1.84–3.70; p interaction = 0.008). Conclusion NOAF complicating AMI is strongly associated with an increased long-term risk of heart. Cumulative incidence of outcome Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): 1. National Natural Science Foundation of China, 2. Natural Science Foundation of Shanghai


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Maciej Debski ◽  
Lesley Howard ◽  
Paula Black ◽  
Angelic Goode ◽  
Christopher Cassidy ◽  
...  

Introduction: The number of people being admitted to hospital in England due to heart failure (HF) has risen by a third in the last five years. Implantable cardiac devices with integrated heart failure diagnostics are capable of combining daily measurements of multiple device-derived parameters and provide a heart failure risk score (HFRS) which might help predict HF worsening. Methods: Between 2015 and 2019 231 consecutive HF device patients were co-managed (CM) by specialist HF nurses in a tertiary centre. Follow-up was truncated at last device transmission in 2019. HF nurses’ interventions to alerts were recorded prospectively. HF-related hospitalisations were collected from hospital records. We analysed the predictive value of baseline variables on the count of days in high HFRS in a negative binomial regression model. The device settings: Optivol CareAlert switched ON vs OFF were compared. Results: 200 patients with CRT-D were followed up for 2.6 [1.0-2.8] years (Figure). Baseline characteristics and their effect on the incidence rate ratio (IRR) of days in high HFRS are presented in Table. A total of 3,486 transmissions were assessed, median 7.3 [5.9-10.0] per patient-year; 591 high HFRS episodes occurred in 115 (58%) pts. Optivol OFF increased the rate of high HFRS being transmitted >30 days after its end (45% vs 35%, P=0.018) and increased the time from episode start to transmission (36 [16-68] vs 24 [8-53] days, P<0.001). Of 21 hospitalisations for decompensated HF, 15 were predicted by high HFRS within 30 days whereas 6 were predated by medium HFRS. Conclusion: Patients who have not had a single high HFRS during follow-up did not need admission for decompensated HF.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Liang ◽  
H Holtstrand-Hjalm ◽  
Y Peker ◽  
E Thunstrom

Abstract Background Obstructive sleep apnoea (OSA) is highly prevalent among patients with heart failure. Accumulating research data suggest that this association is bidirectional. Less is known regarding the long-term impact of OSA and continuous positive airway pressure (CPAP) treatment on incident heart failure. Purpose We addressed the association of severe OSA with development of heart failure, and consequently addressed the impact of efficient CPAP treatment in a sleep clinic cohort. Methods The “Sleep Apnea Patients in Skaraborg (SAPIS)” project was a single center (two sites), open-label, prospective cohort study, conducted in Sweden between 2005 and 2018. All consecutive adults admitted to the Skaraborg Hospital between 2005 and 2011 were registered in a local database, and the follow-up ended in May 2018. Anthropomorphic and clinical characteristics as well as results of the diagnostic cardiorespiratory recordings were documented. Treatment of OSA was based on the clinical routines. OSA was defined as an apnoea-hypopnoea index (AHI) of at least 5 events/hr, and severe OSA consisted of patients with an AHI ≥30 events/hr. Median follow-up for the entire cohort was 8.8 years (interquartile range 7.5–10.1 years). Data regarding incident heart failure were obtained from the medical records and the Swedish Hospital Discharge Register. CPAP use (downloaded reports from the devices) of at least 4 hrs/night was defined as efficient treatment. Results Among 4239 patients with diagnostic sleep recordings, 3185 were free of a known cardiac disease at baseline. Severe OSA was observed among 953 (29.9%). Severe OSA significantly predicted incident heart failure (hazard ratio [HR] 2.42; 95% confidence interval [CI] 1.44–4.06) compared to adults with AHI &lt;30 events/hr, adjusted for age, gender, obesity, hypertension and diabetes mellitus. The adjusted HR for severe OSA was 2.82 (95% CI 1.33–5.99) among inefficiently treated/untreated patients whereas the risk was lower but still meaningful among the individuals who were adherent to CPAP (HR 2.25; 95% CI 0.99–5.15) Conclusion Our results suggest that severe OSA is associated with increased risk for development of heart failure. More than 4 hours of CPAP use per night may be necessary for OSA patients in the primary prevention models. CHF-free survival Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): ALF


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
G Von Olshausen ◽  
T Bourke ◽  
J Schwieler ◽  
N Drca ◽  
H Bastani ◽  
...  

Abstract Aims Iatrogenic cardiac tamponades are a rare but dreaded complication of invasive electrophysiology procedures (EPs). Their long-term impact on clinical outcomes is unknown. This study analyzed the risk of death or serious cardiovascular events in patients suffering from EP related cardiac tamponade requiring pericardiocentesis during long-term follow-up. Methods and results Out of 19997 invasive EPs at our university hospital between January 1998 and September 2018, all patients with EP related periprocedural cardiac tamponade were identified (n=60) and matched (1:3 ratio) to a control group (n=180). After a follow-up of 5 years, the composite primary end point - death from any cause, acute myocardial infarction, TIA/stroke and hospitalization for heart failure – occurred in significantly more patients in the tamponade than in the control group (12 patients (20.0%) vs 19 patients (10.6%); Hazard ratio (HR) 2.53 (95% CI, 1.15–5.58); p=0.021). This was mainly driven by a higher incidence of TIA/stroke in the tamponade than in the control group (HR 3.75 (95% CI, 1.01–13.97); p=0.049). Death from any cause, acute myocardial infarction and hospitalization for heart failure did not show a significant difference between the groups. Hospitalization for pericarditis occurred in significantly more patients in the tamponade than in the control group (HR 36.0 (95% CI, 4.68–276.86); p=0.001). Conclusion Patients with EP related cardiac tamponade are at higher risk for cerebrovascular events during the first two weeks and hospitalization for pericarditis during the first months after index procedure. Despite the increased risk for early complications tamponade patients have a good long-term prognosis without increased risk for mortality or other serious cardiovascular events. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): German Research Foundation


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Samuel ◽  
M Abrahamowicz ◽  
J Joza ◽  
V Essebag ◽  
L Pilote

Abstract Background Atrial fibrillation (AF) and heart failure (HF) are common co-existing conditions. Randomized trial data suggests a reduction in all-cause mortality with catheter ablation (CA) in selected patients, however, whether these results are replicable in a real-world population and persist in the long-term remains to be shown. Purpose To evaluate the long-term effectiveness of CA in AF-HF patients in reducing the incidence of: a) all-cause mortality b) HF hospitalizations, and c) major morbidities (stroke/transient ischemic attack (TIA) and major bleeding). Methods A population-based administrative cohort was created of AF-HF patients with government prescription coverage in Quebec, Canada (1999–2015). Patients who underwent CA (cases) were matched 1:2 to controls using risk-set sampling. Cases were matched on time in the cohort and frequency of hospitalizations. Measured time-invariant confounders were controlled for using inverse probability of treatment weighting (IPTW) and included age, sex, clinical characteristics, presence of cardiac implantable electronic devices, and medication use. Multivariable Cox models adjusted the association of CA with the outcomes for the time varying confounders of the presence of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT), anticoagulation use (warfarin or direct oral anticoagulation), and any antiarrhythmic (AAD) use during follow-up. For non-fatal outcomes, the competing risk of death was accounted for using the Lunn-McNeil approach. Results Of the 87,676 AF-HF patients, 298 underwent CA and were matched to 591 controls. After IPTW, the distribution of covariates was balanced between cases and controls [age 65.6±11.0 vs 61.6±11.6; women 24% vs 20%; CHA2DS2-Vasc score 3.2±2.3 vs 2.9±2.1; CA vs non-CA, respectively; standardized mean differences <0.1 for all]. Over a median follow-up of 3.3 (IQR 1.1–6.4) years, 19 (7.3%) of CA patients died compared to 144 (24.6%) non-CA patients. After weighting and adjustment, CA was associated with a statistically significant reduction in the incidence of all-cause mortality [adjusted HR 0.5 (95% CI 0.3–0.9)]. In addition, there was no statistically significant difference in the incidence of HF hospitalizations over the follow-up [CA: 22.5% vs non-CA: 27.1%; adjusted HR 0.9 (95% CI 0.6–1.2)]. The incidences of stroke/TIA (1.7% vs 6.8%) and major bleeding (1.7% vs 4.9%) for CA vs non-CA were not statistically different. Conclusion In a matched population-based AF-HF cohort, CA was associated with a reduced risk of all-cause mortality compared to patients who did not undergo CA. Although no difference in the risk of HF hospitalizations, stroke/TIA, and major bleeding was detected between CA and non-CA patients, larger studies are warranted. Acknowledgement/Funding Canadian Institute of Health Research; Fonds de recherché du Quebec-Santé, Clinical Research Scholar Award (V. Essebag) and Doctoral Award (M. Samuel)


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M Esteve Pastor ◽  
F Marin ◽  
M Anguita ◽  
M Sanmartin ◽  
C Rafols ◽  
...  

Abstract Background Atrial Fibrillation (AF) patients have higher risk of major adverse cardiovascular events (MACEs). In 2015, the 2MACE score (2 points for metabolic syndrome and age ≥75, and 1 point for myocardial infarction [MI] or revascularization, congestive heart failure [ejection fraction ≤40%] and thromboembolism [stroke or transient ischemic attack]) was described to stratify cardiovascular risk and 2MACE≥3 was related with high risk of MACE in AF patients but a long-term validation in prospective patients under direct anticoagulants has not been performed yet. The aim of this study was to analyse the incidence of cardiovascular events and to validate the 2MACE score as predictor of MACEs. Methods EMIR study [acronym from 'Estudio observacional para la identificaciόn de los factores de riesgo asociados a eventos cardiovasculares Mayores en pacientes con fIbrilaciόn auricular no valvular tratados con un anticoagulante oral directo (Rivaroxaban)'] was an observational, multicenter, post-authorization and prospective study that involved AF patients under oral anticoagulation with rivaroxaban at least 6 months before enrolment. We analyzed baseline clinical characteristics and adverse events after 2.5 years of follow up: annual incidence of thromboembolic events, MACE (composite of nonfatal MI, coronary revascularization and cardiac death) and cardiovascular mortality were analyzed. Results We analyzed 1,433 patients (55.5% women, mean 74.2±9.7 years). 385 (26.9%) patients had 2MACE score ≥3 and of those high-risk patients, 42.1% had previous coronary disease, 12.5% had previous peripheral artery disease, 40.7% had diabetes mellitus, 39% heart failure and 50% had chronic kidney disease (GFR&lt;60 ml/min). After 2.5 (2.2–2.6) years of follow-up, we observed patients with 2MACE score ≥3 had higher rate of adverse events (Table), specially of higher rate of cardiovascular mortality and MACE. Patients with 2MACE score ≥3 had RR 4.09 (2.59–6.45; p&lt;0.001) for MACE. Indeed, patients with 2MACE score ≥3 had around 6-fold risk of cardiovascular death due heart failure than patients with 2MACE score &lt;3 (0.17%/year vs 1.09%/year; p=0.003). 2MACE score had suitable predictive performance for MACE (AUC 0.638 [(0.534–0.742); p=0.010). Conclusion In a Real-world AF patients under rivaroxaban therapy from EMIR registry, the 2MACE score is a good predictor of long-term cardiovascular events, MACE and major bleeding. A 2MACE score ≥3 categorize patients at “high-risk” with almost 4-fold risk of MACE in a long-term follow-up. FUNDunding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Bayer Hispania S.L. Table 1. Adverse events according to 2MACE


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