Trattamento interventistico

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1 Fibrillazione Atriale Trattamento interventistico Milano 5/10/18 Prof. Fiorenzo Gaita University of Turin

2 Mechanisms of AF Trigger Atrial premature contractions (P/T) AF Substrate Anatomical: Critical mass, fibrosis, hypertrophy, Loss of connecting Electrophysiological Short ERP, ERP dispersion, intraatrial conduction delay and block Autonomic Nervous System Vagal /Adrenergic

3

4 Antiarrhythmic therapy in atrialal fibrillation 1749 Quinineine 1785 Digital alis 1936 Procainamide 1954 Disopyramide 1962 Beta Blocking agents 1972 Amiodarone 1978 Propafenone 1982 Flecainide 1984 Sotalol 1995 Ibutilide 1996 Dofetilide 1998 Azimilide ablation surgical l/ transcatheter 2010 Vernakalant 2010 Dronedarone 2000

5 Percent Gaita. Naspe 2001 Antiarrhythmic drugs in atrialal fibrillation 48,7 (39 studies s between en 1968 and 2000) 21,8 AAD for AF (~1 year F-up) 54,6 24,1 Efficacy Side Effects 63,8 34,1 60,6 26,4 Quinidine Propafenone Flecainide Sotalol Amiodarone 10 studies 9 studies 8 studies 5 studies 7 studies 72 22

6 Multiple wavelets theory Electrophysiologic targets of AF ablation Trigger AF Substrate Autonomic Nervous System Coumel Focal theory Substrate: Ganglia ablation Triggers: VVPP SVC CS 1 Linear lesions 1 Electrophysiologic guided PV isolation 2 Ablation of fractionated electrograms 2 Circumferential PV isolation (Anatomical encircling)

7 Who started and when? J. Cox, Maze procedure started in 1990 Substrate modification: linear lesions

8 Different surgical approaches for AF ablation COX 93% MELO 69% SUEDA 68% BENUSSI 77% GAITA 80% KOTTKAMP 82% DENEKE 82% GAITA 85% Gaita F. CEPR 2002;6:401. Mean Efficacy 79.5%

9 Beginning of era of TC ablation Haissaguerre 1996 Jais 1998 F. Gaita 1998 Haissaguerre 1998 Pappone 1999 Kuck 1999

10 Followw-up (months) Success Without drugs With drugs Complications % 25% 31% none % 11% 28% none Predictors of success: ablation in areas with shortest FF interval al, vagal al demonstrated by heart rate variability Gaita et al. Circulation 1998 Jun:97;2136

11 Why right atrium ablation to cure AF? At that time due to a lack of technology (4 mm tip ablation catheters) we were unable to safely reproduce the surgical maze with catheters

12 Cornerstone: e: the right tools 4 mm irrigated/temperature igated/temperature re control ol catheter produces larger and safer lesions, s, decreasing the risk of cerebral vascular accidents RF ablation catheter RF ablation irrigated/cooled catheter 4 mm 4 mm Tsai Circ.1999;

13 Interest moves from the substrate to the triggers 45 pts with idiopathic PAF Haissaguerre et al. N Engl J Med 1998:339; 9; Followw-up: 8 6 months 62% success rate w/out AAD

14 Electroanatomic mapping systems Substrate modification 27 pts: success in 16 pts (59%) 32 pts: success in 2 pts (6%)

15 Catheter ablation of PAF using 3D mapping Population: 27 pts with PAF > 1 year RA linear ablation 8 pts (30 30%) Biatrial ablation 14 pts (51 51%) LA ablation 5 pts (18 18%) success F-up: mos w/o drug 12 pts (44 44%) with drug 4 pts (15%) improvement with drug 4 pts (15%) Conduction block: 21/27 (77%) Complications: 1 DDD PM implant unchanged 7 pts (26%) Pappone et al. Circ 1999;100:

16 Modification of the substrate for idiopathic human AF Population: 45 pts: PAF 37 (82%) Permanent nt 8 pts LA ablation First 13 pts (%) Recurrence rate: 100% Complete linear lesions 0/7pts studied Complications: 1 pericardial tamponade 1 cerebral infarct + RA ablation Biatrial ablation 12 out of 13 pts Recurrence rate: 100% Complete linear lesions 3/8 pts studied Complications: 1 pseudo-aneurysm 2 pericardial effusion RA linear ablation (3 lines) 32 pts Recurrence rence rate: 94% Complete linear lesions 56% (18/32) Complications: 3 RA isolation 7 PM implant 1 retroperitoneal hematoma 1 pneumothorax 3 Pericardial effusions Ernst S, Kuch KH et al Circ 1999;100:

17 Focal ablation of atrial fibrillation 90 pts with paroxysmal AF (97% PV foci - 3% atrial foci) Rhythm outcome at 8 5 month follow-up AF elimination: 64 pts (71%) with no AAD 12 pts (13%) on with AAD 49 pts required 2 or more sessions. Complications ns: pulmonary vein stenosis air embolism hemopericardium reversible e neurological ogical deficit blurred binocular vision 5 pts 5 pts 1 pt. 1 pt. 1 pt. 84% 14% Haissaguerre et al. Circulation 2000;101:

18 Anatomical encircling of PPVVs 26 pts with idiopathic AF Mean procedure duration 6 hours # RF pulses Success: w/o drugs 62 % 85% with drugs 23 % Complications 4% (cardiac tamponade) Pappone et al. Circulation 2000;102:

19 Anatomical encircling PPVVs Population: 251 pts 179 PAF 72 Persistent AF w/o drug: PAF 148pts ( 82%) with drug : 4pts (3%) w/o drug: with drug : Persistent 40 pts (48%) 9 pts (20%) 85% 68% Complications: 2 pericardial tamponade Pappone et al. Circ 2001;104:

20 Evolution of AF CATHETER ablation strategy over the years (Oct 1996-May 2001) = 305 pts RA lines Pts = 35 Procedure duration: 6 h. RX: Culprit PV Pts = 25 Procedure duration: 4,30 h. RX: all PV+Carto Pts = 245 Procedure duration: 4 h. RX: 62 Complications = 0% Complications = 1,3% Complications = 1,4% Success w/o drugs Success w/o drugs Success with drugs 35% Paroxysmal 11% % Paroxysmal 17% % 58% 24% 36% 0 Paroxysmal Persistent

21 ABL CS 1 CS 2 CS 3 CS 4 ABL Cardiology Dept. Civil Hospital Asti Cardiology Dept. Civil Hospit Mauriziano Hospital Torino Success: w/o AAD with AAD CS 5 PAF 271pts 406pts 211pts( s(78%) 27pts( s(10% %) 88% Complications: 1 TIA 2 pericardial effusion 25% of pts underwent to a second procedure Persistent stent AF 135pts 74 pts (55%) 5% 32 pts (24%) 79%

22 The question in 2000 Can pulmonary vein isolation effectively treat also patients with persistent t AF and structural heart disease se?

23 Gaita F. Scaglione M. Calo L. Riccardi R. JACC 2001

24 RIGHT ATRIUM LEFT ATRIUM Paroxysmal al AF Persistent AF

25 2005;111: pts, Permanent AF and Valvular Heart Disease

26 3D left atrial al al mapping g 3 months after procedure 105 pts, Permanent AF and Valvular Heart Disease Complete e Lesions 0% 7 scheme e PVI isolation 65% n 81%

27 With drugs U ;111: Permanent AF and Valvular Heart Disease Pts in SR with drugs PV

28 Without drugs 2005;111: Permanent AF and Valvular Heart Disease Pts in SR without drugs For Long Standing Atrial Fibrillation PV isolation on alone is not sufficient ufficient: U 7 PV we have to modify the substrate adding linear lesions

29 JACC 2004; 43: pts (57 PAF,). Complex Fractionated Atrial Electrograms 84% success rate w/out AAD ( D (16 % redo)

30 What about ablation in patients with structural heart disease?

31 AF ablation in structural heart disease HCM vs. other CMP vs. lone AF Total population : 78 pts F-up: months Success % of success HCM (n = 26) Other cardiopathies (n = 26) idiopathic AF (n = 26) Total 64% 65% 77% PAF 77% 77% 85% AF Pers rs/perm 50% 54% 69% Gaita F et al, Am J Cardiol 2007;99: Major complications: none

32 WHAT ABOUT LONG G-TERM EFFICACY OF AF ABLATION?

33 Mean FU 10 3 years 73% in SR Ann Thorac Surg 2013

34 Verma et al. NEJM 2015

35 p=0.15 Documented AF > 30 seconds after one procedure with or without AAD Verma et al. NEJM 2015

36 Procedural Adverse Events 6%. Verma A et al. N Engl J Med 2015;372:

37 JAMA 2014

38 Circulation Apr 26;133(17)

39 Recurrence of Atrial Arrhythmias in the Catheter Ablation Versus s Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial Jeanne E. Poole MD, George Johnson BSEE, Kristi H. Monahan RN, Hoss Rostami BSMSE, Adam Silverstein MS, Hussein Al-Khalidi PhD, Mauri Wilson RN, Yves Rosenberg MD, MPH, Tristram D. Bahnson MD, Richard A. Robb PhD, Daniel B. Mark MD, MPH, Kerry L. Lee PhD, Douglas L. Packer MD for the CABANA Investigators and ECG Rhythm Core Lab

40 Background CABANA randomized 2204 symptomatic patients with paroxysmal or persistent atrial fibrillation (AF) 1:1 to percutaneous left atrial catheter ablation versus medical therapy Patients were > 65 years or < 65 years with > 1 risk factor for stroke Primary endpoint nt - Composite osite of death, disabling stroke, serious bleeding, or cardiac arrest Packer D et al HRS LBT 2018

41 Cumulative First Recurrence Event Rates After 90-day Blanking Atrial Fibrillation Atrial Fibrillation/Flutter/ Tachycardia (P < ) (P < ) Both CABANA and non-cabana study recorders

42 Atrial Fibrillation/Flutter Atrial Flutter/Tachycardia Ablation v. Drug HR: 0.53 (95% CI, ) P< *Cabana study recording system only

43 Percent AF Burden Holter Analysis by Baseline Pattern of AF Drug Paroxysmal P<0.001 Persistent - LSP P<0.001 Ablation *Cabana study recording system only

44 Conclusions Catheter ablation was associated with a significant relative risk reduction (~50%) in recurrence of atrial arrhythmias Holter-determined AF burden was significantly lower in patients randomized to catheter ablation compared to drug-therapy across 5 years of follow-up

45 Conclusions Secondary endpoint - All cause mortality: 15% reduction with ablation was observed (ITT).(HR 0.85; 95% CI ; p=0.377) non stat significant Analyses by treatment received and per protocol showed significant benefits of ablation for both the primary endpoint and for mortality Packer D et al HRS LBT 2018

46 So what is the state of the art of Atrial Fibrillation Ablation in 2018?

47 AF ablation per year today % RF 91% RF 92% RF 92% RF 6% cryo 7% cryo 6% cryo 6% cryo 1% other 2% other 2% other 2% other

48 2016 AF guidelines ESC Long term rhythm control therapy in AF

49 Thank you for your attention!

50 Target for Paroxysmal AF Pulmonary vein isolation Trigger AF Courtesy of Dr. Damian Sanchez-Quintana Carlo Pappone

51 Substrate Target for pts wihyth h structural heart disease or Persistent AF AF PVI + Linear Lesions (7 scheme) + Complex fractioned electrogram

52

53 External ablation for AF? Focused ultrasound therapy? Adapted from World J Gastroenterol. 20(28):

54 Waiting for the future What can we do today to improve our results ts?

55 By X-Ray Exposure

56 Radiation exposure: additional cancer risk for patients Lifetime additional risk of cancer/examination 1 in 500 Thallium scan Interventional fluoroscopic procedures 1 in 650 Fluoroscopy time 60 TC ablation Coronary stenting 1 in 1000 Abdominal CT Technetium sestamibi scan Chest CT Cancer risk Barium Enema for radiation exposure Bone Scintigraphy in AF ablation: -60 fluoroscopy: 1/650 pt -30 1/ in Lung Scintigraphy Equivalent N of chest X-Rays Modified from Picano BMJ 2004

57 AF transcatheter ablation

58 Lifetime additional risk of cancer/examination Radiation exposure: additional cancer risk for patients 1 in in 650 Fluoroscopy time 60 1 in in in Abdominal CT Chest CT Lung Scintigraphy Thallium scan Interventional fluoroscopic procedures Barium Enema Bone Scintigraphy TC ablation ation Fluoroscopy time 3 TC ablation Coronary stenting Technetium sestamibi scan Cancer risk for radiation exposure in AF ablation: -60 fluoroscopy: 1/650 pt -30 1/ / Equivalent N of chest X-Rays Modified from Picano BMJ 2004

59 2016 Europace (2016) 18,

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