ESC CONGRESS HIGHLIGHTS ARRHYTHMIAS. M. Bertini (Ferrara, IT) Conflicts of Interest none

Transcription

1 ESC CONGRESS HIGHLIGHTS ARRHYTHMIAS M. Bertini (Ferrara, IT) Conflicts of Interest none

2 Data that may change daily practice... Atrial fibrillation OACs in real life - BEYOND program Halvorsen S 2951 OAC and cancer Bögh-Jakobsen C (YIA) 1878 OAC new FXa antidote - ANNEXA-4 study Connally S, NEJM in press 5718 ESC/EHRA LT AF ablation registry 1 yr data Arbelo E 2952 Devices ICD in DCM - DANISH study Köber L NEJM in press 1220 Radiation and devices M.Tajstra (YIA) P692 Multipoint LV Stimulation in CRT Santini L 2380 The Torpedo pacemaker Zurbuchen A (YIA) 1889

3 OACS IN REAL LIFE

4 Bleeding rates of OAC in real life - BEYOND program LOWER risk for significant bleeding and ICH with dabigatran and apixaban, and Method: nationwide cohort study in Norway Patients: pts initiating warfarin (35%), dabigatran (24%), rivaroxaban (21%), apixaban (20%), Follow up HIGHER 6 months risk for GI bleeding 74 yrs, CHA 2 DS 2 VASc with dabigatran and rivaroxaban compared to warfarin PE: Major or CRNM bleeding SE: GI and ICH bleeding Favours NOAC Favours VKA Favours NOAC Favours VKA S. Halvorsen (Oslo, NO), FP 2951

5 REVISIT US - Significant Reduction in the Combined Endpoint for Rivaroxaban vs warfarin Rivaroxaban was associated vs warfarin with a Significant 47% reduction in ICH Non-significant 29% decrease in ischemic stroke Significant 39% reduction in the combined endpoint of ICH and ischemic stroke Rivaroxaban Warfarin HR (95% CI) Rate Rate (%/year) rivaroxaban vs. warfarin (%/year) ICH ( )* HR (95% CI) rivaroxaban vs. warfarin Ischemic stroke ( ) Combined ( )* *p<0.05 Coleman CI et al. Real-world EVIdence on Stroke prevention In patients with atrial Fibrillation in the United States (REVISIT-US) [Presentation at ECAS 2016] Available at: Favors rivaroxaban Favors warfarin

6 REVISIT US No Significant Reduction in the Combined Endpoint for Apixaban vs warfarin Apixaban was associated vs warfarin with a Significant 62% reduction in ICH vs. warfarin Non-significant 13% increase in ischemic stroke vs. warfarin Non-significant 37% reduction in the combined endpoint of ICH and ischemic stroke vs. warfarin Apixaban Warfarin HR (95% CI) Rate (%/year) Rate (%/year) apixaban vs. warfarin HR (95% CI) apixaban vs. warfarin ICH ( )* Ischemic stroke ( ) Combined ( ) *p<0.05 Coleman CI et al. Real-world EVIdence on Stroke prevention In patients with atrial Fibrillation in the United States (REVISIT-US) [Presentation at ECAS 2016] Available at: Favors apixaban Favors warfarin

7 REVISIT US No Significant Reduction in the Combined Endpoint for Dabigatran vs warfarin Dabigatran was associated vs warfarin with a Non-significant 29% reduction in ICH vs. warfarin Non-significant 13% reduction in ischemic stroke vs. warfarin Non-significant 21% reduction in the combined endpoint of ICH and ischemic stroke vs. warfarin HR (95% CI) dabigatran vs. warfarin HR (95% CI) dabigatran vs. warfarin ICH 0.71 ( ) Ischemic stroke 0.87 ( ) Combined 0.79 ( ) Favors apixaban Favors warfarin Coleman CI et al. Real-world EVIdence on Stroke prevention In patients with atrial Fibrillation in the United States (REVISIT-US) [Presentation at ESC 2016]

8 TAKE HOME MESSAGES Efficay and safety of NOACs is confirmed in Real Life clinical practice NOACs in real life behave equally or better than in RCT NOACs lower risk for bleeding including ICH compared to warfarin OAC is underused in clinical practice. NOAcs may improve the use of OAC Stroke Relevant bleeds including ICH

9 OAC AND CANCER

10 Stroke and bleeding risk was assessed in cancer patients on warfarin Method: Nationwide registry of 93,778 AF patients Follow up 1 yr, cancer < 5 yrs in 8 % Risk of stroke Warfarin rate per 100 PY (95%Cl) No Warfarin rate per 100 PY (95%Cl) Hazard rate (95%Cl) Cancer 1.66 ( ) 2.87 ( ) 0.65 ( ) No Cancer 1.61 ( ) 2.76 ( ) 0.68 ( ) Hazard ratio (95% Cl) No warfarin as REF C. Jakobsen, (Hellerup, DK), FP 1878

11 Stroke and bleeding risk was assessed in cancer patients on warfarin Cancer Risk of bleeding Warfarin No Warfarin Warfarin treatment rate per 100 PY (95%Cl) associated rate per 100 PY (95%Cl) with same risks and benefits Hazard rate (95%Cl) in AF patients with and without cancer No reason to withhold warfarin in cancer patients 5.44 ( ) 5.82 ( ) 1.26 ( ) No Cancer 3.43 ( ) 3.63 ( ) 1.28 ( ) Hazard ratio (95% Cl) No warfarin as REF C. Jakobsen, (Hellerup, DK), FP 1878

12 REVERSAL OF FXa INHIBITION

13 Anti factor Xa Activity (ng/ml) Anti factor Xa Activity (ng/ml) Andexanet alfa to reverse Factor Xa inhibition- ANNEXA-4 investigators Method: bolus / infusion given to patients with acute major bleeding <18 hours of last dose Andexanet rapidly reversed FXa inhibition in pts with acute major bleeding Primary endpoint: percent reversal of FXa inhibition and clinical hemostatic efficacy Apixaban Effective bleedings n=20 hemostasis observed Rivaroxaban in 80% bleedings of patients n=26 Baseline End End of 4 Hr 8 Hr 12 Hr of Bolus Infustion Median Percent Change (95%Cl) (-87 to -94) (-85 to -94) (-23 to -46) (-19 to -38) (-27 to -41) Baseline End End of 4 Hr 8 Hr 12 Hr of Bolus Infustion Median Percent Change (95%Cl) (-58 to -94) (-55 to -93) (-27 to -45) (-43 to -57) (-51 to -70) SJ. Connolly, (Hamilton, CA) FP 5718

14 TAKE HOME MESSAGE ARRHYTHMIAS OAC should not be withheld from cancer patients with AF Andexanet can reverse FXa inhibition

15 ESC/EHRA AF ABLATION REGISTRY 1 YEAR DATA

16 1 yr follow up of ESC/EHRA AF ablation registry Background: AF ablations/yr in EU Method/ Patients: 3630 AF pts from 107 centers in 27 countries First ablation 80%, Redos 20% Age 59 yrs, 32% females, Px (68%) persistent (24%), EHRA score 2-3, Complications: Overall 16.3% In hospital 7.8 %, 12 months 10.7 % 1 procedure related death due to Esophageal fistula 12 month mortality 0.5% E. Arbelo (Barcelona, ES), FP 2952

17 Probability of event (%) 1 yr follow up of ESC/EHRA AF ablation registry Freedom from AF recurrence +/- AAD Px 75% AF ablation was successful in 70% of patients over Europe with 1:1:Paroxysmal reasonable safety 2:2:Persistent 3: 3:LS persistent Persistent 71% Long-standing 68% Time to first reported recurrence (in days) 1:1:Paroxysmal :2:Persistent : 3:LS persistent E. Arbelo (Barcelona, ES), FP 2952

18 PRIMARY PROPHYLACTIC ICD IN DILATED CARDIOMYOPATHY HF PATIENTS

19 Cumulative event rate Cumulative event rate Primary prophylactic ICDs in dilated cardiomyopathy - the DANISH study Aim: to study if PP ICD reduces total mortality in HF pts with DCM Method: RCT to ICD +/- CRT or no ICD +/- CRT Primary endpoint: total mortality, others : CV mortality and sudden cardiac death PE: Total mortality Sudden cardiac death Hazard Ratio = 0.87 ( ) p=0.28 ICD reduced sudden cardiac death in pts with dilated cardiomyopathy but not total Years mortality Patients: ICD (n=556) Control (N=560), 64 years, NYHA II/III, LVEF 25% Hazard Ratio = 0.50 ( ) p=0.005 All on OMT and 60 % had CRT Follow up 5.6 years Controls ICD L. Kober (Copenhagen, DK), FP 1220

20 Cumulative event rate Cumulative event rate Mortality by age in DANISH Youngest tertiles < 58 years Oldest tertile - 58 years RR 36% by ICD There was a survival Hazard Ratio = 0.64 benefit ( ) by ICD in younger p-value=0.011 patients Hazard Ratio = 1.2 ( ) p-value= Controls ICD Controls ICD L. Kober (Copenhagen, DK), FP 1220

21 RADIATION THERAPY & DEVICES

22 Does radiation therapy damage ICD/CRT? Background: Aim: Cancer pts often have CRT/ICD. Radiation therapy may harm device and patients. There is little data. To test the impact of radiotherapy on ICD and CRT-D function in vitro in a phantom. Results: A total dose of 78 Gy delivered Charge time of ICD over treatment time Increasing radiation dose was linked to a number of device hazards Battery voltage over treatment time Radiation by helical tomotherapy M. Tajstra, (Zabrze, PL), P692

23 FROM MULTISITE TO MULTIPOINT CRT PACING

24 Multipoint pacing may reduce non responder rate in CRT the Iron MPP study The novel MultiPoint Pacing (MPP) gives two sequential stimuli from different cathodes in a multipolar LV lead Clinical composite score at 6 months Preliminary results suggest better response to CRT with multipoint LV stimulation L. Santini, (Rome, IT), FP 2380

25 THE TORPEDO PACEMAKER - A GLIMPSE INTO THE FUTURE

26 The torpedo-pacemaker lead- and battery-less Torpedo-shaped turbine generator The turbine tested on flow loop setup and generated 32.5 μw at a cardiac output of 4.6 l/min which is 6 x more than the leadless pacemaker A. Zurbuchen, (Bern, CH), FP 1889

27 TAKE HOME MESSAGE ARRHYTHMIAS Primary prophylactic ICD in DCM reduces SCD but not total mortality Radiation may damage ICD and CRT devices Future pacemakers may be lead and battery-less

28 ESC CONGRESS HIGHLIGHTS THANK YOU! M. Bertini (Ferrara, IT) Conflicts of Interest none

29 Remote Management of Heart Failure Using Implanted Devices and Formalized Follow-up Procedures (REM-HF) Multicentre, prospective, randomised, non-blinded, controlled trial comparing: Usual care + weekly Remote Monitoring vs Usual care alone Primary outcome first event of death from any cause or unplanned CV hospitalisation Sept March 2014: 1650 patients recruited from 9 English hospitals M. Cowie (London, GB) FP 1223

30 REM-HF: First Event of Death from any Cause or Unplanned Cv Hospitalisation Mortality + CV hospitalizations Primary End Point Mortality M. Cowie (London, GB) FP 1223

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