Ablazione della fibrillazione atriale: dubbi presenti e prospettive future

Transcription

1 Ablazione della fibrillazione atriale: dubbi presenti e prospettive future Carlo Pappone, MD, PhD, FACC Cardiac Pacing & Electrophysiology Department, Director Villa Maria Group, Italy

2 Atrial Fibrillation Microreeentrant circuits Sueda Ann Thorac Surg 1997 Vagal Ganglia Pappone Circulation 2004 PV foci Haissaguerre NEJM 1998 LOM Hwang Circulation 2000 CS Oral JCE 2003 Mandapati Circulation 2000 Dominant Spiral Wave

3 The original AFFIRM STUDY Rate control is associated with a trend towards a better outcome!

4 Does AF merit really some treatment?

5 How many times AF can increase mortality DO MORTALITY REALLY EXIST? ,5 2, ,6 JACC 2006

6 AF & Comorbidities Camm AJ et al, Am J Cardiol 1996;78:3A-11A

7 Chronic AF: Morbidity Stroke Dementia Heart Failure Systemic consequence of AFib (e.g., chronic renal failure, Alzheimer, organ failure due to peripheral embolism)

8 CT/MRI for risk stratification

9 Heart Failure LV volumes Increase (systolic & diastolic) Ventricular filling, PA pressure Decrease 1 wk 1 month Cardiac output & ejection fraction Onset of AF 1 wk 1 month Cardiac output Ejection fraction Termination of AF Schumacher B et al, Am J Cardiol 1998;82:29n-36n

10 AAD FOR PAROXYSMAL AF J Am Coll Cardiol 2003

11 AAD FOR CHRONIC AF Pappone, NEJM 2006

12 Table 3. Effect of Being in Sinus Rhythm on All-cause Mortality and Adverse events in All Patients or According to Treatment Groups.* Hazard Ratio (95%CI) for Death Hazard Ratio (95%CI) for Adverse Events All Patients 0.24 (0.16 to 0.37) 0.22 (0.15 to 0.31) Ablation Group 0.21 (0.09 to 0.48) 0.33 (0.16 to 0.68) Medical Group 0.19 (0.12 to 0.32) 0.13 (0.08 to 0.21) *For this analysis, maintenance of sinus rhythm was entered as a time-dependent variable into the Cox regression analysis (see legend to Figure 3). CI denotes confidence interval. Pappone, JACC 2003

13 Two years later 2004 the presenceunlikely of SR but not AAD use maintainance was associated with itsr intrinsically that SR is per seis associated with aone lower risk ofand death. These significantly lower mortality adverse harmful and can argue that the the presence of SR was associated with a results suggest that if aan effective method event rates, questioning results of AFFIRM, warning trend toward higher mortality lower risk of death. for maintaining SR with fewer side used effects, it RACE and PIAF. could be attributable to the means to AFFIRM REVISITED PAPPONE, MORTALITY AND MORBIDITY, JACC 2003 mightachieve improve survival. SR. AFFIRM REVISITED PAPPONE, MORTALITY AND MORBIDITY, JACC 2003

14 Atrial fibrillation is a progressive disease. Lone AF seems to progress less rapidly

15 What results with ablation?

16 Evolution of Techniques Year Pts 1999 Ernst Haissaguerre Pappone AF Type Ablative Approach AF-freedom PAF Focal PV Ablation PAF RA LA Biatrial PAF LA Biatrial 0 0 Haissaguerre Pappone Pappone Oral Pappone Oral PAF PAF, CAF PAF, CAF PAF, CAF PAF, CAF PAF PV Isolation CPVA CPVA PV Isolation CPVA CPVA PV Isolation Pappone Kuck Nademanee Haissaguerre Jackman Oral Pappone , PAF PAF PAF, CAF CAF PAF CAF PAF CPVA Double Lasso CFE Ablation PVI + Lines GPI Ablation CPVA CPVA ,

17 AF CATHETER ABLATION

18 Atrial Fibrillation Technologies CARTO NavX? Stereotaxis Cryo Lasso US balloon Ablation Frontiers

19 If we all agree, the scientific progress will never move forward

20 Atrial Fibrillation the Common Rationale

21 PV ABLATION the history 1999, critical mass 2000, fibrillatory waves classiffication 2004, vagal innervation localization 2001, mother waves localization

22 CATHETER ABLATION FOR AF ENDPOINTS 1. 3D RECONSTRUCTION 2. PV ISOLATION 3. VAGAL DENERVATION 4. SUBSTRATE MODIFICATION (pw isolation) 5. NOT INDUCIBLE AF/AT 6. BIATRIAL ABLATION

23 PAROXYSMAL ATRIAL FIBRILLATION PV ISOLATION AND SUBSTRATE MODIFICATION VOLTAGE PRE IMPEDANCE VOLTAGE POST Pappone et al. JACC 2008

24 PAROXYSMAL ATRIAL FIBRILLATION 2. PV ISOLATION WITH 3D PREABL INCOMPLETE LINE POSTABL Circulation

25 Electrical isolation of encircled areas Isolation means no electrically conducted activity in both direction 100% Lasso/CARTO correspondence Heart Rhythm in press

26 HOW TO FIND GAPS SIGNAL ANALYSIS GAP Incomplete lesion Heart Rhythm in press

27 HOW TO FIND GAPS DIFFERENTIAL PACING Pacing site Heart Rhythm in press

28 HOW TO FIND GAPS DIFFERENTIAL PACING Pacing site Heart Rhythm in press

29 PAROXYSMAL ATRIAL FIBRILLATION NEED FOR SUBSTRATE MODIFICATION

30 BENEFIT OF THE INTERVENTION Worldwide > pt tretaed No. Pts F/u (mo.) Efficacy PAPPONE ablation drugs % 22% NATALE ablation drugs % 56% ablation drugs % 26% ablation drugs % 23% 1 2 FDA study 3 JAIS4 1 JACC 2006; 2 JAMA 2005; 3 submitted; 4 Circulation 2008

31 Circumferential pulmonary vein ablation is more successful than ADT for prevention of PAF with few complications. Atrial fibrillation ablation warrants consideration in selected patients in whom ADT had already failed and maintenance of sinus rhythm is desired. Pappone JACC 2006

32 RECONDUCTING PV AS A CAUSE OF RECURRING AF J Am Coll Cardiol 2007

33 IS BENEFIT LONG-TERM SUSTAINED? Screened patients (n = 334) Inclusion criteria not met (n = 136) Enrolled patients with paroxysmal AF (n = 198) Randomization CPVA (n = 99) Recurrent AT/AF (n = 4) 2 after index and >1 AAD 2 after redo CPVA and >1 AAD Persistent/permanent AF (n = 1) After redo CPVA and 1 AAD trial Pappone, APAF 2 3 year Sinus rhythm (n = 95) 77 after index CPVA 18 after redo CPVA ADT (n = 99) Sinus rhythm (n = 62) 11 after 1 AAD 1 after >1 AAD 50 after switch to CPVA 11/26 of unablated patients progressed to chronic AF (42%) Recurrent AT/AF (n = 37) 26 after >1 AAD 11 after switch to CPVA 17 persistent AF after >1 AAD 11 permanent AF after >1 AAD

34 LONG-TERM ABLATION SUPERIORITY 1.0 log-rank p<0.001 Proportion of AF-free patients 0.9 CPVA ADT 0.1 1y 0 0 Pappone, APAF 2 3 year y y 24 Months of Follow-up

35 The first FDA study: CPVA vs. AAD AF Freedom Wilber, Pappone, submitted

36 The Milan Data Wilber, Pappone, submitted

37 The First FDA study THE MILAN DATA Population: 50 patients 2 patients dropped after random to AAD 31 patients assigend to CPVA 17 patients started a new AAD Mean Age: 57 years Male: 33/50 Mean AF episodes/month: 15 AFib history 4 years LA Dilation 48% Wilber, Pappone, submitted

38 The first FDA study: CPVA vs. AAD 100 (94)% success rate* *1 patient experienced AT *1 patient was found in asymptomatic AF *15 patient crossed over to CPVA Wilber, Pappone, submitted

39 The first FDA study: Safety 1 patient developed a pericardial effusion prolonging hospital stay but not requiring pericx. No stroke/tia 1 patient died 20 months after ablation for non cardiovascular reasons Wilber, Pappone, submitted

40 In which patients? Permanent AF too?

41 PERMANENT AF STEPS BEYOND CPVA ABLATION STEPS 1. CPVA 2. ENDO CS 3. SEPTUM 4. LAA 5. EPI CS 6. RIGHT ATRIUM 7. CFE

42 BENEFIT OF THE INTERVENTION Worldwide > pt treated No. Pts F/u (mo.) Efficacy PAPPONE1 Biatrial Ablation 12 87% HAISSAGU ERRE2 ablation 12 87% ORAL PAPPONE CAFE3 CPVA % 74% Chronic AF Submitted JCE Circulation NEJM

43 BENEFIT OF THE INTERVENTION Consensus has been reached about ablation efficacy in selected patients Pappone, NEJM 2006

44 The Stepwise Strategy Goal: organization of a chaotic AF into a single mappable AT or SR (RF cardioversion) cardioversion Method: progressive substrate ablation to de-complex AF tailored in individual patient

45 INDUCIBILITY PROTOCOL At each RF-SR use inducibility to decide if moving on next step ENDOPOINT: no more inducibility

46 PERMANENT AF CLINICAL OUTCOME

47 Dying of ablation?

48 Safety in an experienced center (N=19029) Death 0 (0%) Pericardial effusion 20 (0.23%) Stroke 1 (0.011%) TIA 4 (0.05%) Tamponade 7 (0.08%) Atrial-esophageal fistula 1 (0.012%) PV stenosis 0 (0%) Incisional LA tachycardia 601 (6.99%) Transient ERAF 1166 (17%) * Overall complication rate including post CPVA LA AT 7.30% Major complication rate 0.38% over 8,682 AFib patients treated with CPVA or CPVA-M* Minor complication preventable with the CPVA-M *

49 NAVIGATION & ABLATION Possible Complications Embolization Perforation Pulmonary Vein Stenosis Circumflex Artery Occlusion Esophageal perforation

50 frontespizio

51 Usual presentation is late : 6 to 10 days after the procedure; no acute in hospital case has been reported Pappone, Circulation 2004

52 ATRIAL TACHYCARDIA Mitral isthmus Posterior wall Circle-gaps

53 CPVA Standard updated 8% 4%

54 Summary Stadardization of therapy Pulmonary Vein Ablation has become the stadard of care

55 You can die of ablation (1/1000) Survey to 0.1% peri-procedure risk 0.3% risk for disabling stroke

56 Incidence of Death According to Type of Complication. Complication death / overall events Incidence no. % - Tamponade 7/ Atrio-esophageal fistula 2/ Massive pneumonia 2/ Peripheral embolism - Stroke 3/ Myocardial infarction 1/ Torsade de pointes 1/ Septicemia (3 weeks after procedure) 1/ Sudden respiratory arrest 1/ Acute pulmonary vein occlusion of both lateral veins 1/ Internal bleeding 3/ Anaphylaxis 1/ Acute respiratory distress syndrome 1/ Esophageal perforation from intra-operative TEE probe 1/ Intra-cranial bleeding under oral anti-coagulation therapy in prior stroke 1/ Courtesy of R. Cappato

57 Matter of patients, of course

58 Complications of Catheter Ablation University of Milan (N=19029) Matter of experience, also Pericardial effusion and tamponade Atrial Tachy + LA maze - Ostial CPVA + - Irrigated Junctional CPVA catheter CPVA-M - Vagal Denervation

59 COMPLICATIONS ABLATION GUIDELINES Be aware of what risk you are incurring to Train also in complication detection and management

60 Success is not the same anywhere

61 AF Freedom High enrolling, 98% FDA STUDY Low enrolling, 48% Wilber, Pappone, submitted

62 The new perspective

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67 Remote Case at HRS 2006 Demonstrated the vision for EP networking 1) INTEGRATION: One screen 2) SIMPLIFICATION: One keyboard & mouse 3) COMMUNICATION: High speed network Boston Milan Enabled because of -Safe gentle catheter -Computerized control

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