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

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.

scholarly journals A prospective multicentre randomized all-comers trial to assess the safety and effectiveness of the ultra-thin-strut sirolimus-eluting coronary stent Supraflex: 2-year results of the TALENT trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Gao ◽  
N Kogame ◽  
P Smits ◽  
P Tonino ◽  
R Moreno ◽  
...  
Keyword(s):  
Protocol Analysis ◽  
Composite Endpoint ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Polymeric Coating ◽  
Absolute Difference ◽  
Funding Source ◽  
Target Lesion Revascularisation ◽  
Private Company

Abstract Background and purpose Supraflex is a sirolimus-eluting stent with a biodegradable polymeric coating and 60um ultra-thin struts. In the TALENT study, we found the Supraflex stent was non-inferior to the Xience stent for a device-oriented composite endpoint (DOCE, defined as cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation) at 12 months in an all-comer population. Additionally, per-protocol analysis showed a significantly lower clinically indicated target lesion revascularisation (CI-TLR) in the Supraflex group than in the Xience group. We now present the 2-year follow-up results. Methods The TALENT study was a prospective, randomised, single-blind, multicentre study across 23 centres in Europe. Eligible participants underwent percutaneous coronary intervention in an all-comers fashion in vessels of 2.25–4.5 mm. Patients were randomized (1:1) to implantation of either Supraflex or Xience (NCT02870140). Results Between October 21, 2016 and July 3, 2017, 720 patients with 1046 lesions were randomly assigned to Supraflex, and 715 patients with 1030 lesions to Xience. At 24 months, DOCE had occurred in 49 patients (6.9%) in the Supraflex group and in 56 patients (7.9%) in the Xience group (absolute difference −1.0% [95% CI: −3.7 to 1.7], Plog-rank=0.491). Per-protocol analysis at 24 months showed CI-TLR occurred in 21 and 30 patients in the Supraflex and Xience, respectively (3.3% versus 4.5%, absolute difference −1.2%, [95% CI: −3.3 to 0.9], Plog-rank=0.267). Conclusion In an all-comer population, at 2-year follow-up, the use of Supraflex stent was at least as safe and efficacious as Xience stent. However, the significantly lower rate of CI-TLR shown in patients treated with Supraflex at 1-year was no longer retained in the 2-year results. Whether theoretical advantage of ultra-thin strut drug eluting stents Supraflex can translate into clinical benefit or not will be further elucidated through a total of 3 years of follow-up. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): SMT

Linfoistiocitosi eritrofagocitica

2003 ◽  
Vol 16 (3) ◽  
pp. 365-372 ◽  
Author(s):  
F. Caranci ◽  
A. D'Amico ◽  
F. Briganti ◽  
R. Migliorati ◽  
C. De Fusco ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Bone Marrow ◽  
Nervous System ◽  
White Matter ◽  
White Matter Abnormalities ◽  
Diffuse White Matter ◽  
Multisystem Involvement ◽  
Identification And Characterization

Erithrophagocytic lymphohistiocytosis is a rare disease characterized by exaggerated histiocytic proliferation and activation12 and multisystem involvement including visceral organs, lymph nodes, bone marrow and central nervous system4. Magnetic Resonance (MR) examination was performed in 10 patients with previously diagnosed Erithrophagocytic lymphohistiocytosis. This study was aimed at assessing MR accuracy in the identification and characterization of central nervous system lesions. MR findings show a good correlation with areas of parenchymal and meningeal lymphohistiocytic infiltration5, demonstrating diffuse white matter abnormalities in the early stages and necrotic areas with parenchymal volume loss as terminal findings4. In addition, MR allows the follow-up after chemotherapy and bone marrow transplantation2,3. Although rare, EL should be differentiated from other pediatric patchy white matter abnormalities5.

scholarly journals Murine transfer of a human gene variant associated with exceptional longevity displays senolytic effects both in immune compartment and endothelium of aged mice

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Ciaglia ◽  
F Montella ◽  
M Malavolta ◽  
A Carrizzo ◽  
V Lopardo ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Human Gene ◽  
Control Group ◽  
Lymphoid Tissues ◽  
Funding Source ◽  
M2 Macrophages ◽  
Private Company ◽  
Hematopoietic Stem ◽  
Exceptional Longevity ◽  
Age Related

Abstract   The persistence and accumulation of senescent cells has been shown to potentially play a role in the pathophysiology of age-related cardiovascular diseases. Indeed with time, a decline in immune efficacy, termed immunesenescence, and a deleterious secretory phenotype of senescent cells (SASP) generate that inflammatory background mainly mediating the elderly cardiovascular phenotype. Long Living Individuals (LLI) which delay aging, represent a model of positive biology and an exceptional resource to study and find a way to improve general public health. Previous studies from our group have shown that a human gene associated with exceptional longevity (LAV-BPIFB4) was able to block the atherosclerotic process in ApoE−/− mice by conferring the animals with a pro-resolving M2 macrophages profile. Furthermore, LAV-BPIFB4 promotes the recruitment of hematopoietic stem cells, reparative vascularization and frailty reduction. Here we sought to underpinn the role of LAV-BPIFB4 in counteracting the age-related remodeling of the immune responses. The effects of systemic adeno-associated viral vector-mediated LAV-BPIFB4 gene transfer on the immune dynamics in old mice have been investigated by an extensive flow cytometric approach in lymphoid tissues (bone marrow, spleen and peripheral blood). C57BL/6J mice were assigned to two age-matched experimental groups: a treatment group (AAV-LAV-BPIFB4; N=6 mice, aged 18–23 months and a control group (AAV-GFP; N=6 mice, aged 18–23 months. 30th and 60th day since the beginning of the infection, SA-beta Gal substrate has been used to identify CD45+ senescent cells in freshly isolated PBMC, splenocytes, bone marrow (BM)-derived cells. As expected, we monitored an increase in SA-betaGal activity in blood. This increase is most significant in CD11b+ myeloid cells, whithout affecting neither CD3+T neither NK1.1+Natural Killer (NK) cell compartment. Notably 30 days AAV-LAV-BPIFB4 infection and to a more the 60 days-treatment, resulted in a significant decrease in senescent pool of peripheral immune cells and a concomitant enrichment of senescent cells in spleen. Concomitantly, aorta from AAV-LAV treated mice showed significant reduction in SA-beta Gal positive area. Furthermore a LAV-BPIFB4 induction of pro-resolving M2 macrophages compared to control group was documented in the main haemocateretic organ. As consequence the senolytic effect of LAV-BPIFB4 gene-therapy well correlated with the rescue of proliferative index of splenocytes upon PHA stimulation, and their functional protective response to lipopolysaccharide (LPS) in term of IL-6 and TNF-alpha secretion. The restoration of a protective and balanced immune response finally reflected the reduction of senescent phenopype acquired by mouse aortic endothelial cells during the aging process in vivo. A better underpinning of the senolytic action of LAV-BPIFB4 may offer a valuable therapeutic tool to reverse aging phenotype causing most of cardiac diseases Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Cariplo Foundation (n.2016-0874) to AAP and CV

Long-term prognostic benefit of beta-blockers use after discharge in patients with Tako-Tsubo syndrome

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Jamhour-Chelh ◽  
S Raposeiras-Roubin ◽  
I Nunez-Gil ◽  
E Abu-Assi ◽  
D Aritza Conty ◽  
...  
Keyword(s):  
Large Scale ◽  
Beta Blockers ◽  
Funding Source ◽  
Prognostic Impact ◽  
Private Company ◽  
Cox Analysis ◽  
The Impact ◽  
Long Term Mortality

Abstract Background Tako-tsubo Syndrome (TS) seems to be associated with a catecholamine-mediated mechanism. However, the impact of beta-blockers (BB) in-hospital and after discharge still remain uncertain. Objectives: The purpose of the study was to examine whether BB use after discharge in patients with TS, was associated with lower long-term mortality and recurrence. Methods Using a national multicentre large-scale inpatient database (RETAKO Registry), we analysed patients with a definitive TS diagnosis. Results A total of 970 patients were analysed (568 with BB therapy and 402 no-BB therapy). After discharge and over a median of follow-up of 1.1 years, treatment with BB have no shown prognostic effectiveness in terms of mortality and TS recurrence in unadjusted and adjusted Cox analysis (HR 0.86; 95% CI: 0.59 to 1.27; and 0.95; 95% CI: 0.57–1.13, respectively). Conclusions This data suggests that use of beta-blockers after hospital discharge has not shown long-term prognostic benefit in patients with Tako-tsubo Syndrome. Prognostic impact of BB in TS. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Retako webpage was funded by a non-conditioned Astrazeneca scholarship.

Device-device communication stability of leadless anti-tachycardia pacemaker and subcutaneous implantable cardioverter defibrillator over 18 months

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F.V.Y Tjong ◽  
R.E Knops ◽  
B Swackhamer ◽  
B Koop ◽  
B Soltis ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Linear Regression Analysis ◽  
Funding Source ◽  
Private Company ◽  
Leadless Pacemaker ◽  
Significant Difference ◽  
System Migration ◽  
Termination Time ◽  
Time Point

Abstract Background A novel modular cardiac rhythm management (mCRM) therapy approach is evaluated in this study: the performance of an anti-tachycardia pacing enabled leadless pacemaker (LP) commanded by a subcutaneous-ICD (S-ICD) via wireless, intra-body, device-device communication (DDC). Objectives To investigate long-term DDC performance of linked S-ICD to LP (mCRM System) and factors that impact DDC performance. Methods The mCRM System was implanted in 37 canine subjects: 33 with an S-ICD and an LP; 4 with an S-ICD and 2 LPs. The S-ICD was implanted using a Parsonnet pouch in the first 8 subjects. Communication thresholds were measured in three postures up to 18 months. Percent tissue encapsulation of the LP was measured at necropsy and ranged from 6% to 100% (mean: 62%). S-ICD system migration was evaluated radiographically at implant vs. at necropsy in two planes (anterior-posterior and left lateral) and evaluated 0–3 scale: none, minimal, moderate, significant. Communication thresholds were evaluated at 0 vs. 3 days using a t-test and 3 days through 18 months using a linear regression analysis. A repeated measures generalized linear model (GLM) was used to evaluate if test posture, percent tissue encapsulation of the LP, Parsonnet pouch use, or S-ICD system migration (no/ minimal migration vs. moderate/significant migration) were significant predictors of DDC performance at the subject's termination time point. Results DDC was successful for each tested posture and time point for all subjects (n=37), with 355 tests in Left Lateral (LL), 371 tests in Dorsal (D), and 355 tests in Right Lateral (RL). Follow up data are available up to 18 months for 19 subjects at the time of this abstract; additional follow-up data will be added to the analysis for presentation. Communication thresholds decreased between 0 days and 3 days (LL P<0.01, D P<0.01, RL P<0.05) and did not change significantly from 3 days through 18 months (LL P=0.90, D P=0.83, RL P=0.83). The GLM showed that there is no significant difference in communication thresholds for test posture (P=0.24 LL vs. D, P=0.24 RL vs. D), percent tissue encapsulation of the LP (P=0.63), Parsonnet pouch use (P=0.65), or S-ICD system migration (P=0.95). Conclusion Longitudinal studies demonstrate low and stable communication thresholds of a novel mCRM system over time for all three tested postures, regardless of factors such as LP encapsulation, Parsonnet pouch use, or S-ICD system migration. Device Communication Threshold Stability Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Boston Scientific

Impact of physical activity on all-cause mortality in European patients with atrial fibrillation: a report from the ESC-EHRA EORP AF General Long-Term Registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Vitolo ◽  
M Proietti ◽  
S Harrison ◽  
Z Kalarus ◽  
L Tavazzi ◽  
...  
Keyword(s):  
Physical Activity ◽  
Atrial Fibrillation ◽  
Funding Source ◽  
Private Company ◽  
Cox Regression Analysis ◽  
Kaplan Meier ◽  
All Cause Mortality ◽  
The Impact

Abstract Background Physical activity (PA) may have a beneficial contribution for outcomes in patients with atrial fibrillation (AF). Purpose We aimed to evaluate the impact of self-reported PA in a large contemporary cohort of European AF patients on the risk of all-cause mortality. Methods We analyzed patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. Self-reported PA was categorized, on the basis of reported time spent exercising, as follows: i) No PA; ii) Occasional PA; iii) Regular PA; iv) Intense PA. The primary outcome was all-cause death. Results Over 11096, a total of 8699 (78.4%) patients (mean age (SD) 69.1 (11.5); 40.7% female) had available data about PA and follow-up observation and were included in the analysis. Of these, 3703 (42.6%) reported no PA, 2829 (32.5%) occasional PA, 1824 (21.0%) regular PA, with only 343 (3.9%) reporting intense PA. With the 4 increasing PA categories, mean age, proportion of female patients, CHA2DS2-VASc and HAS-BLED scores were progressively lower (all p<0.001). Use of vitamin K antagonist (VKA) declined across the classes of PA (53.1% vs. 52.2% vs. 44.5% vs. 33.9%, p<0.001), while use of non-VKA OACs (NOACs) conversely increased. During a mean (SD) 680.6 (171.5) days of follow-up, there were a total of 848 (9.7%) all-cause death events. Based on Kaplan-Meier analysis, there was a progressively lower cumulative risk for all-cause death according to PA categories [Figure]. A multivariable Cox regression analysis, adjusting for CHA2DS2-VASc score, use of OAC at baseline and type of AF, found a lower risk of all-cause death associated with increasing levels of PA (Hazard ratio [HR]: 0.69, 95% confidence interval [CI]: 0.59–0.81 for occasional PA, HR: 0.45, 95% CI: 0.35–0.58 for regular PA, HR: 0.41, 95% CI: 0.23–0.76 for intense PA, when compared to no PA). In a sensitivity analysis, a regular-intense PA was inversely associated with occurrence of cardiovascular (CV) death, after multivariable adjustments for comorbidities (HR: 0.54, 95% CI: 0.37–0.77). Conclusions In a large contemporary cohort of European AF patients, self-reported PA was found to be inversely associated with all-cause death and CV death. Kaplan-Meier Curves Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Since the start of EORP, several companies have supported the programme with unrestricted grants

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