Μηνύματα από τις σπουδαιότερες μελέτες στην ηλεκτροφυσιολογία το διάστημα

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1 Μηνύματα από τις σπουδαιότερες μελέτες στην ηλεκτροφυσιολογία το διάστημα Δημήτριος M. Κωνσταντίνου Ειδικός Καρδιολόγος, MD, MSc, PhD, CCDS Πανεπιστημιακός Υπότροφος

2 Dr. Konstantinou has received grants from Medtronic

3 Presentation outline Paroxysmal AF Cryoballoon vs. RF ablation of pulmonary veins -Freeze-AF, FIRE AND ICE Contact Force sensing vs. standard RF ablation catheters -TOCCASTAR, EFFICAS II Persistent AF Pulmonary vein isolation vs. additional substrate modification -STAR-AF Silent AF Implantable Loop Recorders vs. conventional ECG monitoring techniques -CRYSTAL-AF

4 Presentation outline (cont.) Pharmacotherapy for paroxysmal AF Low dose dronedarone + moderate dose ralonazine -The Harmony Trial Improving CRT response rates Emerging CRT algorithms -AdaptivCRT Multipoint Pacing -IRON-MPP registry Primary prevention of sudden cardiac death The role of prophylactic ICD implantation in DCM -DANISH trial

5 Cryoballoon vs. Radiofrequency ablation of pulmonary veins

6 N Engl J Med 2016;374:

7 Primary efficacy endpoint: 1. recurrence of AF (lasting >30 s), 2. occurrence of Afl/AT, 3. prescription of class I/III AADs or 4. repeat ablation N Engl J Med 2016;374:

8 treatment of patients with drug-refractory paroxysmal AF, PV isolation by means of CB ablation was non-inferior to RF ablation in terms of efficacy and safety. N Engl J Med 2016;374:

9 Contact force-sensing ablation catheter vs. standard, non-force-sensing catheter

10 Circulation. 2015;132:907-15

11 CF-sensing ablation catheter was non-inferior to the standard non force-sensing catheter with respect to shortand long-term efficacy and safety. The use of optimal CF (>10 g) was associated with higher success. Circulation. 2015;132:907-15

12 Contact Force (CF) guidelines: 1. target CF of 20 g (range g) AND 2. minimum Force-Time Integral of 400 gs Continuity Index (CI) assessment* *no guidance on CI was given to operators Europace 2015;17:

13 Conduction gaps were assessed by remapping of PVs after 3 months Europace 2015;17:

14 In EFFICAS II, PV lines isolated initially with a CI<6 (low CI) had a 98% chance of remaining isolated.

15 Pulmonary vein isolation vs. additional substrate modification in persistent AF

16 N Engl J Med 2015;372:

17 Among patients with persistent AF, we found no reduction in the rate of recurrent AF when either linear ablation or ablation of complex fractionated electrograms was performed in addition to pulmonary-vein isolation. More extensive ablation may cause new, iatrogenic areas of arrhythmogenesis where tissue is incompletely ablated or linear block is not achieved. Perhaps neither complex electrograms nor lines are the correct supplemental targets for ablation N Engl J Med 2015;372:

18 Facts: 1. Up to 40% of ischemic strokes initially classified as cryptogenic 2. Silent AF is present in 30% of cryptogenic stroke patients 3. Standard 24-hour Holter monitoring limited sensitivity for the detection of new AF (2%-6%) Circ Arrhythm Electrophysiol. 2016;9:e003333

19 Implantable Loop Recorders

20 In conclusion, extended long-term monitoring with an ICM uncovered AF in a high proportion of patients with prior CS or TIA. Detection of AF resulted in OAC therapy prescription in the majority of patients. Circ Arrhythm Electrophysiol. 2016;9:e003333

21 All patients had a DDD pacemaker implanted for standard clinical indications before enrollment All devices had atrial arrhythmia detection algorithms+egm storing capacity Circ Arrhythm Electrophysiol. 2015;8:

22 Combining 2 drugs with complementary electrophysiological properties (increased efficacy) at lower doses (decreased toxicity) Multi-channel blockade Contraindicated in HF due to negative inotropism from block of L-type Ca ++ channels (concentration dependent) Lower doses should be less cardio-depressant Late Na + current inhibition decreases cellular Na + & Ca ++ loading thereby EAD and DAD occurrence

23 moderate dose ranolazine combined with reduced dose dronedarone can decrease AF yet maintain good tolerance/safety in the population enrolled. Circ Arrhythm Electrophysiol. 2015;8:

24 THERE ARE OPPORTUNITIES TO IMPROVE CRT RESPONSE POTENTIAL REASONS FOR SUBOPTIMAL CRT RESPONSE 1 1 Mullens W, et al. J Am Coll Cardiol. 2009;53: Claria MRI Quad SureScan CRT-D Customer Presentation

25 ADAPTIVCRT ALGORITHM OPERATION LV pacing can be at least as efficacious as BiV pacing In patients with SR and normal AV conduction, pacing only the LV with appropriate AV intervals can result in even superior LV and RV function compared with standard BiV pacing The algorithm is intended to provide ambulatory CRT optimization, allow more physiologic ventricular activation and greater device longevity in patients with normal AV conduction by reducing unnecessary RV pacing 25 Claria MRI Quad SureScan CRT-D Customer Presentation

26 Heart Rhythm 2012;9:

27 43.8% absolute reduction in RV pacing The acrt algorithm was safe and at least as effective as BiV pacing with comprehensive echocardiographic optimization across a variety of endpoints. Heart Rhythm 2012;9:

28 % patient improved in Clinical Composite Score ADAPTIVCRT IMPROVES PATIENT OUTCOMES BY Improving CRT Response by 12% 1 For patients in sinus rhythm, with normal AV conduction and LBBB 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 81% p = % Normal AV AdaptivCRT Echo-optimised CRT AdaptivCRT: Produced mostly synchronized LV pacing (73% +/- 25%) Resulted in better clinical response at 6 months (81% vs. 69%) 1 Birnie D, et al. Heart Rhythm. 2013;10: Claria MRI Quad SureScan CRT-D Customer Presentation

29 ADAPTIVCRT IMPROVES PATIENT OUTCOMES BY Providing a 46% reduction in AF risk *1 For all patients * Compared to echo-optimized BiV pacing. 1 Martin D, et al. Clinical Outcomes with Adaptive Cardiac Resynchronization Therapy: Long-term Outcomes of the Adaptive CRT Trial. HFSA Late Breakers. September 23, Claria MRI Quad SureScan CRT-D Customer Presentation

30 ADAPTIVCRT IMPROVES PATIENT OUTCOMES BY Reducing a patient s odds of a 30-Day HF Readmission * by 59% 1 For all patients * Readmissions following an HF hospitalization. 1 Starling RC, Krum H, Bril S, et al. Impact of a Novel Adaptive Optimization Algorithm on 30- Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. July 2015;3(7): Claria MRI Quad SureScan CRT-D Customer Presentation

31 THERE ARE OPPORTUNITIES TO IMPROVE CRT RESPONSE POTENTIAL REASONS FOR SUBOPTIMAL CRT RESPONSE 1 1 Mullens W, et al. J Am Coll Cardiol. 2009;53: Claria MRI Quad SureScan CRT-D Customer Presentation

32 MULTIPLE POINT PACING OPTION TO IMPROVE CRT RESPONSE IN SOME NON-RESPONDERS Multiple Point Pacing allows to pace from 2 LV electrodes instead of one. Potential benefits of Multiple Point Pacing: Capture a larger area of the LV Engage areas around scar tissue Improve pattern of de/repolarization Improve acute/chronic hemodynamics Improve resynchronization Several small studies have been shown that Multiple Point Pacing is safe 2,3 and resulted in similar or better acute hemodynamics 4-8 and better chronic outcomes 5 versus standard BiV pacing. Multiple Point Pacing may benefit non-responders compared to standard CRT Claria MRI Quad SureScan CRT-D Customer Presentation

33 Compared with conventional CRT, MPP resulted in an additional increase in ejection fraction and clinical composite response. Europace 2016 doi: /europace/euw094

34 How to choose the optimal vector/timing? Europace 2016 doi: /europace/euw094

35 The results revealed different practices among centers, and establishing the optimal programming in order to maximize the benefit of MPP remains a challenging issue. Europace 2016 doi: /europace/euw094

36 DOI: /NEJMoa

37 All time-to-event curves appeared to diverge during the initial 5 years of the trial and then to converge DOI: /NEJMoa

38 31% of deaths due to noncardiovascular causes DOI: /NEJMoa

39 Patients with nonischemic HF may be less prone to death from arrhythmia than patients with ischemic HF better medical treatment and CRT also may have reduced the risk of death from arrhythmia for all patients with HF. At present, it is therefore unclear whether patients who are eligible for CRT should routinely receive an ICD. the benefit of ICD implantation with respect to sudden cardiac death is convincing, and patients who are not expected to die from other causes may be good candidates for ICD implantation. DOI: /NEJMoa

40 Take Home Messages In paroxysmal AF, PV isolation by means of CB ablation is non-inferior to RF ablation in terms of efficacy and safety -shorter procedural time, steeper learning curve -longer fluoroscopy time, more phrenic nerve palsy (usually resolves spontaneously) In paroxysmal AF, CF-sensing ablation catheter is non-inferior to the standard non force-sensing catheter with respect to short- and longterm efficacy and safety -incorporating CF guidelines (i.e. CF of 20g AND min FTI of 400gs) and aiming for contiguous lesion formation (low continuity index<6), initial PV lines have a 98% chance of remaining isolated after 3 months

41 Take Home Messages In persistent AF, adding linear ablation or ablation of complex fractionated electrograms to standard pulmonary-vein isolation did not reduce the rate of recurrent AF In patients with prior CS or TIA, extended long-term monitoring with an ICM uncovered AF almost 9 times more often compared to conventional monitoring which resulted in OAC therapy prescription in the majority of cases Moderate dose ranolazine combined with reduced dose dronedarone can decrease AF yet maintain good tolerance/safety

42 Take Home Messages The acrt algorithm was safe and at least as effective as BiV pacing with comprehensive echocardiographic optimization -Superior clinical outcomes may be expected in patients with SR, normal AV conduction and LBBB Compared with conventional CRT, MPP resulted in an additional increase in ejection fraction and clinical composite response -establishing the optimal programming in order to maximize the benefit of MPP remains a challenging issue Prophylactic ICD implantation in symptomatic DCM patients did not reduce long-term mortality but -it did halve the risk for sudden cardiac death overall -it did reduce all cause mortality in younger patients

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