scholarly journals Clinic time required to manage cardiac implantable electronic device patients: a time and motion workflow evaluation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Biundo ◽  
A Burke ◽  
S Rosemas ◽  
D Lanctin ◽  
E Nicolle
Keyword(s):  
Remote Monitoring ◽  
Electronic Device ◽  
Future Research ◽  
Funding Source ◽  
Staff Time ◽  
Private Company ◽  
Remote Transmission ◽  
Time And Motion ◽  
Time Required

Abstract Background The population with cardiac implantable electronic devices (CIEDs) is growing, creating workload for device clinics to manage these patients. However, the CIED follow-up workflow is poorly understood. This study sought to characterize the workflow and staff time for CIED patient management. Methods A time and motion workflow evaluation was performed in 6 U.S. CIED clinics, which manage an average of 4,217 patients. Each task involved in CIED management was repeatedly timed, including all manufacturers, during 1 business week at each clinic. Mean staff time for a remote transmission and an in-person visit were calculated, including all clinical and administrative (e.g: scheduling, documentation) activities related to the encounter. Annual staff time for follow-up of 1 patient was modeled using CIED transmission data for the 6 clinics, guidelines for CIED follow-up, and published literature. Results 124 clinic visits and 1,374 remote monitoring activities were observed. Staff time required per remote transmission ranged from 12.1–13.4 minutes (depending on the CIED type), and time per visit was 43.4–51.0 minutes. Including all remote and in-person follow-ups, the estimated total staff time per year to manage one pacemaker, ICD, CRT, and ICM patient was 2.3, 2.4, 2.4, and 9.3 hours, respectively (Table 1). Conclusion CIED clinic workflow is complex and requires significant staff time. Remote monitoring is an efficient complement to in-office visits, allowing for continuous follow-up of patients. Future research should examine heterogeneity in clinic processes to identify the most efficient workflow. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic

Abstract 286: Clinic Time Required To Manage Cardiac Implantable Electronic Device Patients: A Time And Motion Workflow Evaluation

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Eliana Biundo ◽  
Alan Burke ◽  
Sarah C Rosemas ◽  
David Lanctin ◽  
Emmanuelle Nicolle
Keyword(s):  
Remote Monitoring ◽  
Patient Management ◽  
Electronic Device ◽  
Future Research ◽  
Staff Time ◽  
Remote Transmission ◽  
Time And Motion ◽  
Number Of Patients ◽  
Time Required

Background: The number of patients with cardiac implantable electronic devices (CIEDs) is growing, creating workload for device clinics to manage this population. Remote monitoring of CIED patients is a guidelines-recommended method for optimizing treatment in CIED patients in combination with in-person follow-up. However, the specific steps involved in CIED management, as well as the HCP time required for these activities, are not well understood. The aim of this study was to quantify the clinic staff time requirements associated with the remote and in-person management of CIED patients. Methods: A time and motion workflow evaluation was performed in 6 U.S. CIED clinics. Participating clinics manage an average of 4,217 (range: 870-10,336) CIED patients. The duration of each task involved in CIED management was repeatedly timed, for all device models/manufacturers, during one business week (5 days) of observation at each clinic. Mean time for review of a remote transmission and for an in-person clinic visit were calculated, including all clinical and administrative (e.g., scheduling, documentation) activities related to the encounter. Annual staff time (inclusive of all clinical and administrative staff) for follow-up of 1 CIED patient was modeled using device transmission data for the 6 clinics, clinical guidelines for CIED follow-up, and published literature (Table 1). Results: During 6 total weeks of data collection, 124 in-person clinic visits and 1,374 remote transmission review activities were observed and measured. On average, the total staff time required per remote transmission ranged from 11.9-13.5 minutes (depending on the CIED type), and time per in-person visit ranged from 43.4-51.0 minutes. Including all remote and in-person follow-ups, the estimated total staff time per year to manage one Pacemaker, ICD, CRT, and ICM patient was 2.3, 2.4, 2.4, and 9.3 hours, respectively. Conclusion: CIED patient management workflow is complex and requires significant staff time in cardiac device clinics. Remote monitoring is an efficient complement for in-office visits, allowing for continuous follow-up of patients with reduced staff time required per device check. Future research should examine heterogeneity in patient management processes to identify the most efficient workflow.

Abstract 14046: An International Assessment of the Clinic Staff Time Required to Manage Cardiac Device Patients

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Eliana Biundo ◽  
Juliette Hennion ◽  
Sarah C Rosemas ◽  
David Lanctin ◽  
Emmanuelle Nicolle
Keyword(s):  
Electronic Device ◽  
Standard Of Care ◽  
Clinic Visit ◽  
Staff Time ◽  
Cardiac Device ◽  
Clinic Staff ◽  
Remote Transmission ◽  
Time And Motion ◽  
Time Required

Introduction: Remote monitoring (RM) of cardiac implantable electronic device (CIED) patients is guideline-recommended standard of care alongside in-office follow-up. However, overall workload requirements for device management are not well understood, which may hinder implementation of optimal follow-up strategies including remote solutions. This study sought to characterize processes and clinic staff time required for remote and in-person device follow-up of a CIED patient. Methods: A time and motion workflow evaluation was performed in 11 CIED clinics: 6 US; 5 Europe (UK, France, Germany). Participating clinics manage an average of 5,758 (range: 870-22,000) CIED patients. The duration of each CIED management task was repeatedly timed during 1 business week (5 days) of observation at each clinic. All device models/manufacturers were included. Mean staff time for a remote transmission and an in-person clinic visit were calculated, including clinical and administrative tasks. Annual staff time for follow-up of 1 CIED patient was modeled using data on CIED transmission volume, clinical guidelines, and published literature. Results: A total of 276 in-person clinic visits and 2,173 RM activities were observed. Mean staff time required per remote transmission ranged from 9.4-13.5 minutes for therapeutic devices, and 11.3-12.9 mins for insertable cardiac monitors (ICMs), while staff time per in-person visit ranged from 37.8-51.0 mins and 39.9-45.8 mins, respectively (Table 1). The estimated annual time to manage one therapeutic device patient was lower (1.6-2.4 hours) than an ICM patient (7.7-9.3 hours), due to fewer device follow-ups. Conclusions: RM allows for efficient and continuous care as a complement to in-person follow-up. However, overall CIED patient follow-up requires considerable staff time. These data should be considered in addressing barriers to RM adoption, such as challenges in workflow implementation and inconsistent reimbursement.

Clinic Time Required for Remote and In-person Management of Cardiac Device Patients: A Time and Motion Workflow Evaluation (Preprint)

2021 ◽  
Author(s):  
David Lanctin ◽  
Eliana Biundo ◽  
Marco Di Bacco ◽  
Sarah Rosemas ◽  
Emmanuelle Nicolle ◽  
...  
Keyword(s):  
Patient Management ◽  
Clinic Visit ◽  
Future Research ◽  
Staff Time ◽  
Cardiac Device ◽  
Cardiac Implantable Electronic Devices ◽  
Time And Motion ◽  
Number Of Patients ◽  
Time Requirements ◽  
Time Required

BACKGROUND The number of patients with cardiac implantable electronic devices (CIEDs) is growing, creating substantial workload for device clinics. OBJECTIVE This study aimed to characterize the workflow and quantify clinic staff time requirements to manage CIED patients. METHODS A time and motion workflow evaluation was performed in 11 US and European CIED clinics. Workflow tasks were repeatedly timed during one business week of observation at each clinic. Observations were inclusive of all device models/manufacturers present. Mean cumulative staff time required to review a Remote device transmission and for an In-person clinic visit were calculated, including all necessary clinical and administrative tasks. Annual staff time for follow-up of 1 CIED patient was modeled using CIED transmission volumes, clinical guidelines, and published literature. RESULTS A total of 276 in-person clinic visits and 2,173 remote monitoring activities were observed. Mean staff time required per remote transmission ranged from 9.4-13.5 minutes for therapeutic devices (pacemaker, ICD, CRT) and 11.3-12.9 mins for diagnostic devices (insertable cardiac monitors (ICMs)). Mean staff time per in-person visit ranged from 37.8-51.0 mins and 39.9-45.8 mins, for therapeutic devices and ICMs respectively. Including all remote and in-person follow-ups, the estimated annual time to manage one CIED patient ranged from 1.6-2.4 hours for therapeutic devices and 7.7-9.3 hours for ICMs. CONCLUSIONS CIED patient management workflow is complex and requires significant staff time. Understanding process steps and time requirements informs implementation of efficiency improvements, including remote solutions. Future research should examine the heterogeneity in patient management processes to identify the most efficient workflows.

scholarly journals Clinic time required to manage remote monitoring of cardiac implantable electronic devices: impact of outsourcing initial data review and triage

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
E Nicolle ◽  
D Lanctin ◽  
S Rosemas ◽  
M De Melis
Keyword(s):  
Initial Data ◽  
Remote Monitoring ◽  
Staff Time ◽  
Clinic Staff ◽  
Remote Transmission ◽  
External Monitoring ◽  
Time Savings ◽  
Monitoring Center ◽  
Time Required ◽  
Monitoring Service

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Medtronic Background Remote monitoring is guideline-recommended to manage cardiac implantable electronic device (CIED) patients. With the continuous growth of implanted patients, clinic workload to review transmissions is increasing. Outsourcing initial data review and triage to an external monitoring center could be a valuable option for more efficient allocation of staff time, as high-skilled healthcare professionals can focus on patients in need rather than non-actionable data. Purpose The objective was to estimate the potential clinic staff time saved when outsourcing part of remote transmission review. Methods A previous time and motion evaluation described workflow tasks and time required for remote transmission review (4 EU sites, 674 observations). From real-world experience with a third-party monitoring service, the steps that can be outsourced were determined considering existing clinic-driven protocols for triage and transmission escalation. Staff time required with and without the monitoring service was thus modeled and compared. Results Outsourcing to an external monitoring center can reduce clinic staff time between 77.4% and 84.7% depending on device type. Absolute time savings range from 32.7 to 82.6 hours per year per 100 patients for therapeutic devices, and 301.3 hours for insertable cardiac monitor (ICM) patients, due to the higher frequency of transmissions in diagnostic devices. Conclusion Time to review remote transmissions can become overwhelming for clinics as growing CIED population often outpaces available staffing resources. Outsourcing initial review and triage to an external monitoring center (ensuring quality and regulatory compliance) can be an efficient option to save dedicated staff and facility time for other crucial healthcare activities. Clinic Staff Time Savings Per YearPacemakerICDCRTICMTRANSMISSIONS PER PATIENT PER YEARGreen (no further review required when outsourcing)3.04.35.020.8Yellow/Red (medical action/decision required)0.60.80.93.8ANNUAL STAFF TIME PER PATIENT, minutesNo outsourcing25.346.658.5219.7Outsourcing to monitoring center5.77.78.938.9ANNUAL STAFF TIME PER 100 PATIENTS, hoursNo outsourcing42.277.697.4366.2Outsourcing to monitoring center9.612.914.964.8TIME SAVED PER 100 PATIENTS, hours (%)32.7 (77.4%)64.7 (83.4%)82.6 (84.7%)301.3 (82.3%)Abstract Figure. Outsourcing Remote Transmission Review

scholarly journals Silent cerebral embolisation during TAVI: evolution, predictors and neurocognitive effects

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M De Carlo ◽  
R Liga ◽  
G.M Migaleddu ◽  
M Scatturin ◽  
C Spaccarotella ◽  
...  
Keyword(s):  
White Matter ◽  
Median Number ◽  
Funding Source ◽  
Private Company ◽  
Diffuse White Matter ◽  
Transcatheter Aortic Valve ◽  
Age Related ◽  
Cerebral Mri ◽  
Neurocognitive Evaluation

Abstract Background Most patients undergoing transcatheter aortic valve implantation (TAVI) develop silent cerebral ischemic lesions (SCIL) detectable at magnetic resonance imaging (MRI). The natural history and clinical relevance of SCIL are not well established. We aimed to assess the characteristics, predictors, evolution, and neurocognitive effects of SCIL. Methods Cerebral MRI was performed within 7 days before TAVI to assess baseline status and age-related white matter changes (ARWMC) score. MRI was repeated postoperatively to assess the occurrence, location, number and dimensions of SCIL. Patients developing SCIL underwent a third MRI at 3–5 months follow-up. A neurocognitive evaluation was performed before TAVI, at discharge and at 3-month follow-up. Results Of the 117 patients enrolled, 96 underwent a postprocedural MRI; SCIL were observed in 76% of patients, distributed in all vascular territories, with a median number of 2 lesions, median diameter 4.5 mm, and median total volume 140 mm3. Independent predictors of SCIL occurrence were a higher baseline ARWMC score and the use of self-expanding or mechanically-expanded bioprostheses. Among 47 patients who underwent follow-up MRI, only 26.7% of postprocedural SCIL evolved into a gliotic scar. SCIL occurrence was associated with a more pronounced transient neurocognitive decline early after TAVI and with a lower recovery at follow-up. Conclusions SCIL occur in the vast majority of patients undergoing TAVR and are predicted by a more diffuse white matter damage at baseline and by the use of non-balloon-expandable prostheses. Although most SCIL disappear within months, their occurrence has a limited but significant impact on neurocognitive function. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): unrestricted grants from Edwards Lifesciences SA, Nyon, Switzerland, and from Medtronic Italia SpA, Milan, Italy

Benefits of tafamidis in patients with advanced transthyretin amyloid cardiomyopathy

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Rapezzi ◽  
A.V Kristen ◽  
B Gundapaneni ◽  
M.B Sultan ◽  
M Hanna
Keyword(s):  
Disease Severity ◽  
Nyha Class ◽  
Funding Source ◽  
Class Iii ◽  
Private Company ◽  
Risk Of Death ◽  
6Mwt Distance ◽  
All Cause Mortality ◽  
Amyloid Cardiomyopathy

Abstract Background In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT), tafamidis was shown to be an effective treatment for patients with transthyretin amyloid cardiomyopathy (ATTR-CM). Further assessment of the efficacy of tafamidis in patients with more advanced ATTR-CM would aid treatment decisions. Purpose To characterize the benefits of tafamidis in patients with advanced ATTR-CM. Methods In ATTR-ACT, ATTR-CM patients were randomized to tafamidis (n=264) or placebo (n=177) for 30 months. Efficacy outcomes included all-cause mortality and frequency of cardiovascular (CV)-related hospitalisations. Key secondary endpoints were change from baseline to Month 30 in 6MWT distance and KCCQ-OS score. Efficacy assessments in NYHA Class III patients at baseline (n=141) were a pre-specified analysis. In a post-hoc analysis, mortality and CV-related hospitalizations were assessed in all patients grouped into quartiles of increasing disease severity based on 6MWT distance at baseline. Longer-term all-cause mortality (as of 1 Aug 2019) was assessed in NYHA Class III patients utilizing data from ATTR-ACT patients who enrolled in a long-term, extension study (LTE) and continued treatment with higher dose tafamidis (n=55; median treatment duration 51.6 months); or, if previously treated with placebo, started tafamidis treatment (placebo/tafamidis; n=63 [50.1 months]). Results In advanced ATTR-CM patients (NYHA Class III), tafamidis reduced the risk of death (HR [95% CI] 0.837, [0.541, 1.295], P=0.4253), and the decline in 6MWT distance (LS mean [SE], 31.6 (22.1) m; P=0.1526) and KCCQ-OS score (LS mean [SE], 13.1 (5.0); P=0.0090), vs placebo. Paradoxically, there was a higher frequency of CV-related hospitalizations with tafamidis (RR [95% CI] vs placebo, 1.411 [1.048, 1.900]). In all patients by 6MWT quartile, CV-related hospitalizations/year with tafamidis and placebo increased with disease severity, with the exception that placebo-treated patients in the highest severity quartile had fewer CV-related hospitalisations (0.73) than those in the third quartile (0.92). Mortality with tafamidis and placebo increased, and was greater with placebo, in every quartile (Figure). Survival (NYHA Class III patients in ATTR-ACT and LTE) was improved with high dose tafamidis with longer term follow-up (HR vs placebo/tafamidis [95% CI], 0.6569 [0.4175, 1.0336]; P=0.0692). Conclusions These analyses, including longer-term follow-up, demonstrate that patients with advanced ATTR-CM benefit from tafamidis. The decrease in CV-related hospitalisations in more severe patients treated with placebo suggests that the comparatively greater hospitalisation frequency in NYHA Class III patients treated with tafamidis is a consequence of their lower mortality rate. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was sponsored by Pfizer

scholarly journals RNAi inhibition of angiopoietin-like protein 3 (ANGPTL3) with ARO-ANG3 mimics the lipid and lipoprotein profile of familial combined hypolipidemia

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
G.F Watts ◽  
C Schwabe ◽  
R Scott ◽  
P Gladding ◽  
D Sullivan ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dose Response ◽  
Minimal Change ◽  
Funding Source ◽  
Private Company ◽  
Good Tolerability ◽  
Duration Of Action ◽  
Mixed Dyslipidemia ◽  
Genetic Deficiency

Abstract Background Elevated LDL-C and triglyceride rich lipoproteins (TRLs) are independent risk factors for cardiovascular disease (CVD). Genetic deficiency of angiopoietin-like protein 3 (ANGPTL3) is associated with reduced circulating levels of LDL-C, triglycerides (TGs), VLDL-C, HDL-C and reduced CVD risk, with no described adverse phenotype. ARO-ANG3 is a RNA interference drug designed to silence expression of ANGPTL3. Single doses of ARO-ANG3 have been shown to reduce ANGPTL3, TGs, VLDL-C and LDL-C in healthy volunteers (HVs, AHA 2019). We report the effects of multiple doses of ARO-ANG3 in HVs with a focus on the duration of action. Methods ARO-ANG3 was administered subcutaneously to HVs on days 1 and 29 at doses of 100, 200 or 300 mg (n=4 per group). Measured parameters included ANGPTL3, LDL-C, TGs, VLDL-C and HDL-C. Follow up is ongoing. Results All HVs have received both doses and follow-up is currently through week 16 (12 weeks after second dose). Mean nadir for ANGPTL3 levels occurred 2 weeks after the second dose (−83–93%) with minimal change for 200 and 300 mg but 16% recovery for 100 mg at week 16. Mean TGs and VLDL-C reached nadir earlier (3 wks, −61–65%) without apparent dose response and minimal change for any dose at wk 16. LDL-C nadir occurred 4–6 wks after the second dose (−45–54%), again with minimal evidence for dose response or change through wk 16. HDL-C was reduced 14–37% at wk 16. ARO-ANG3 was well tolerated without serious or severe adverse events or dropouts related to drug. The most common adverse events have been headache and upper respiratory infections. Conclusions Genetic deficiency of ANGPTL3 is a cause of familial combined hypolipemia and is associated with a decreased risk of CVD. Using RNAi to selectively suppress ANGPTL3 production reproduces these genetic effects with a duration of at least 12 weeks following a second dose and with good tolerability over 16 wks. ANGPTL3 inhibition results in lowering of LDL-C and TRLs which may confer protection against CVD in patients with atherogenic mixed dyslipidemia. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Arrowhead Pharmaceuticals

Baseline characteristics and follow-up outcomes in routine clinical practice patients categorised by renal function in the ETNA-AF-Europe registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R De Caterina ◽  
M Gwechenberger ◽  
A Bakhai ◽  
P Monteiro ◽  
P Kelly ◽  
...  
Keyword(s):  
Renal Function ◽  
Total Mortality ◽  
Haemorrhagic Stroke ◽  
Risk Scores ◽  
Funding Source ◽  
Private Company ◽  
Group I ◽  
Baseline Characteristics ◽  
Event Rates

Abstract Background Edoxaban is an oral factor Xa inhibitor anticoagulant with 50% renal clearance, and proven efficacy and safety in patients (pts) with atrial fibrillation (AF). The post-authorisation, observational, ETNA-AF-Europe registry (NCT02944019) assessed the risks and benefits of edoxaban in pts with AF from 10 European countries. Purpose Evaluate baseline characteristics and event rates in pts categorised by creatinine clearance (CrCl) at 1-year follow-up of the ETNA-AF-Europe registry. Methods In this analysis, pts were divided into three groups according to CrCl: ≤50 ml/min (I), 50–80 mL/min (II) and ≥80 mL/min (III) (calculated using Cockcroft-Gault). Outcomes were descriptively analysed. Results Pts with the lowest CrCl (Group I) were mostly females, and had a higher mean age, lower body weight, higher stroke and bleeding risk scores and were considered more frail than those with higher CrCl (Groups II and III) (Table). Group I experienced higher rates of stroke or SEE, major or CRNM bleeding, cardiovascular death, and had a higher total mortality (Figure). Rates of intracranial haemorrhage (ICH) and haemorrhagic stroke (intracerebral and subarachnoid haemorrhage) were low and similar in pts across the range of CrCl. Conclusions Those with lower CrCl had more comorbidities and higher event rates than those with higher CrCl, with the exception of ICH and haemorrhagic stroke. A steep rise in the proportion of pts perceived as frail and in overall mortality in the lowest renal function tertile, raises the question whether low renal function is a determinant or a correlate of mortality. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Daiichi Sankyo Europe GmbH, Munich, Germany

Canadian Registry of Electronic Device Outcomes: remote monitoring outcomes in the Abbott battery performance alert—a multicentre cohort

EP Europace ◽  
2021 ◽  
Author(s):  
Sharath Kumar ◽  
Jason Davis ◽  
Bernard Thibault ◽  
Iqwal Mangat ◽  
Benoit Coutu ◽  
...  
Keyword(s):  
Remote Monitoring ◽  
Primary Outcome ◽  
Electronic Device ◽  
Electronic Devices ◽  
Cardiac Resynchronization ◽  
Device Performance ◽  
Cardiac Implantable Electronic Devices ◽  
All Cause Mortality ◽  
Multicentre Cohort

Abstract Aims Cardiac implantable electronic devices with device advisories have the potential of device malfunction. Remote monitoring (RM) of devices has been suggested to allow the identification of abnormal device performance and permit early intervention. We sought to describe the outcomes of patients with and without RM in devices subject to the Abbott Premature Battery Depletion (PBD) advisory with data from a Canadian registry. Methods and results Patients with an Abbott device subject to the PBD advisory from nine implantable cardioverter defibrillator (ICD) implanting centres in Canada were included in the registry. The use of RM was identified from baseline and follow-up data in the registry. The primary outcome was detection of PBD and all-cause mortality. A total of 2666 patients were identified with a device subject to the advisory. In all, 1687 patients (63.2%) had RM at baseline. There were 487 deaths during follow-up. At a mean follow-up of 5.7 ± 0.7 years, mortality was higher in those without a remote monitor compared with RM at baseline (24.7% vs. 14.5%; P < 0.001). Pre-mature battery depletion was identified in 36 patients (2.1%) with RM vs. 7 (0.7%) without RM (P = 0.004). Time to battery replacement was significantly reduced in patients on RM (median 5 vs. 13 days, P = 0.001). Conclusion The use of RM in patients with ICD and cardiac resynchronization therapy under advisory improved detection of PBD, time to device replacement, and was associated with a reduction in all-cause mortality. The factors influencing the association with mortality are unknown and deserve further study.

Relationship between frailty and all-cause mortality in patients with atrial fibrillation: a report from the ESC-EHRA EURObservational research programme AF general long-term registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Proietti ◽  
M Vitolo ◽  
S Harrison ◽  
G.A Dan ◽  
A.P Maggioni ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Frailty Index ◽  
Primary Study ◽  
Funding Source ◽  
Private Company ◽  
Kaplan Meier ◽  
Increased Risk ◽  
All Cause Mortality

Abstract Introduction Frailty is a major health determinant for cardiovascular disease. Thus far, data on frailty in patients with atrial fibrillation (AF) are limited. Aims To evaluate frailty in a large contemporary cohort of European AF patients, the relationship with oral anticoagulant (OAC) prescription and with risk of all-cause death. Methods We analyzed patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. A 38-items frailty index (FI) was derived from baseline characteristics according to the accumulation of deficits model proposed by Rockwood and Mitnitsky. All-cause mortality was the primary study outcome. Results Out of the 11096 AF enrolled patients, data for evaluating frailty were available for 6557 (59.1%) patients who have been included in this analysis (mean [SD] age 68.9 [11.5], 37.7% females). Baseline median [IQR] CHA2DS2-VASc and HAS-BLED were 3 [2–4] and 1 [1–2], respectively. At baseline, median [IQR] FI was 0.16 (0.12–0.23), with 1276 (19.5%) patients considered “not-frail” (FI<0.10), 4033 (61.5%) considered “pre-frail” (FI 0.10–0.25) and 1248 (19.0%) considered “frail” (FI≥0.25). Age, female prevalence, CHA2DS2-VASc and HAS-BLED progressively increased across the FI classes (all p<0.001). Use of OAC progressively increased among FI classes; after adjustments FI was not associated with OAC prescription (odds ratio [OR]: 1.09, 95% confidence interval [CI]: 0.98–1.19 for each 0.10 FI increase). Conversely, FI was directly associated with vitamin K antagonist (VKA) use (OR: 1.26, 95% CI: 1.18–1.34 for each 0.10 FI increase) and inversely associated with non-VKA OACs (NOACs) use (OR: 0.82, 95% CI: 0.77–0.88). FI was significantly correlated with CHA2DS2-VASc (Rho= 0.516, p<0.001). Over a median [IQR] follow-up of 731 [704–749] days, there were 569 (8.7%) all-cause death events. Kaplan-Meier curves [Figure] showed an increasing cumulative risk for all-cause death according to FI categories. A Cox multivariable analysis, adjusted for age, sex, type of AF and use of OAC, found that increasing FI as a continuous variable was associated with an increased risk of all-cause death (hazard ratio [HR]: 1.56, 95% CI: 1.40–1.73 for each 0.10 FI increase). An association with all-cause death risk was found across the FI categories (HR: 1.71, 95% CI: 1.23–2.38 and HR: 2.88, 95% CI: 2.02–4.12, respectively for pre-frail and frail patients compared to non-frail ones). FI was also predictive of all-cause death (c-index: 0.660, 95% CI: 0.637–0.682; p<0.001). Conclusions In a European contemporary cohort of AF patients the burden of frailty is significant, with almost 1 out of 5 patients found to be “frail”. Frailty influenced significantly the choice of OAC therapy and was associated with (and predictive of) all-cause death at follow-up. Kaplan-Meier Curves Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Since the start of EORP programme, several companies have supported it with unrestricted grants.

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