The HISTORIC-AF TRIAL

Transcription

1 European Prospective Multicenter Study of Hybrid Thoracoscopic and Transcatheter Ablation of Persistent Atrial Fibrillation: The HISTORIC-AF TRIAL Claudio Muneretto 1, Gianluigi Bisleri 1, Gianluca Polvani 2, Antonio Curnis 1, Luca Bontempi 1, Fabrizio Rosati 1, Elisa Merati 2, Gaetano Fassini 2, Massimo Moltrasio 2, Claudio Tondo 2, Ralf Krakor 3 1 University of Brescia, Brescia, Italy; 2 University of Milan, Milan; 3 THG Staedtisches Klinikum, Dortmund, Germany MASSIMO MOLTRASIO, M.D. Cardiac Arrhythmia Research Center, Department of Cardiovascular Sciences, Centro Cardiologico Monzino, University of Milan, Italy

2 DISCLOSURES Consulting fees/honoraria: Medtronic, INC

3 What is Known: my personal point of view I m not a surgeon but an electrophysiologist) In the population of patients with persistent atrial fibrillation, the optimal selection for and the strategy of catheter ablation has yet to be determined. There are few data regarding multi-year outcome after persistent AF ablation Little is known about prognostic factors for success In addition to patients symptoms, other characteristics, such as continuous AF duration, presence of structural heart disease, or left atrium diameter, should be used to decide with the patient whether ablation is a valid treatment option

4 J Am Heart Assoc months (single procedure) Late SINGLE PROCEDURE success 67% 54% 52% 42% 53% 64%

5 J Am Heart Assoc % 50%

6 J Am Heart Assoc % persistent AF

7 Single Procedure Outcome (off drugs) y ys ys.

8 Single Procedure Outcome Role of A-Fib termination

9 Circ Arr. E Multiple Procedure Outcome 74 5 ys ys.

10 Persistent A-Fib: > 7 days Long-standing Persistent A-Fib: > 1 year

11 Multiple procedures outcome persistent vs long-standing persistent (AF>1 year) 42%

12 Voltage map after transcatheter PVI (1st procedure) Areas of isolation 1.5 mv 0 mv

13 Voltage map 6 months after PVI + endocardial BOX lesion (2 procedures)

14 RF Ablation of gaps (3 rd procedure)

15 Voltage map after third endocardial RF procedure

16 catheter surgery SURGERY?

17 catheter catheter surgery surgery

18 Rational of Hybrid : To join different entities including technologies and techniques, taking the best of each and eliminating their respective disadvantages Medical therapy inadequate Limited success of isolated catheter-based ablations (20-55%) Isolated open-chest surgical procedures (Maze) not always accepted by cardiologists and patients Hybrid treatment of AF by endoscopic PV isolation + trans-catheter ablation

19 2005

20 At the completion of the surgical ablation, an intraoperative evaluation of conventional electrophysiological end-points was performed in order to demonstrate entrance and/or exit block across the box lesion

21 Principal Investigator: Claudio Muneretto MD, PhD - University of Brescia European Multicenter Registry Department of Cardiac Surgery, University of Brescia - Italy Department of Cardiology and Cardiac Surgery, University of Milan Italy THG Staedtisches Klinikum, Dortmund, Germany

22 EFFICACY: success rate target of surgical ablation > 60% (Freedom from AF without EP procedure within 12 months and without AADs at 6 months after surgery) SAFETY: serious adverse events (SAEs) within 30 days after surgery (death, stroke or TIA, myocardial infarction, TE events, bleeding, access infection, PM implantation, PV stenosis, esophageal fistula, cardiac tamponade or pericardial effusion requiring intervention)

23 Symptomatic Persistent AF or Long Standing Persist. AF Documented failure of at least one AAD (Vaughan Williams Class I or III) Absence of left atrial thrombus within 30 days prior to enrollment Age 18 to 75 years old Willing and capable of providing Informed Consent

24 Long Standing Persisent AF for more than 5 ys Left Atrial size greater than 55 mm and LVEF 40% History of Cerebro-vascular disease (stroke, TIA) within 6 months prior to enrollement Presence of underlying structural heart disease and previous cardiac surgery

25 Controindication to AC therapy or no compliance Organic disease or disturbance of hemostasis Pregnancy, planned pregnancy od breastfeeding Concomitant cardiac surgery procedure planned

26 SURGICAL PROCEDURE : Totally endoscopic epicardial ablation (BOX LESION + RA SVC IVC isolation) + EP PROCEDURE - IF NEEDED in case of AF recurrencies: To assess integrity of BOX Lesion and PV isolation Terminate fragmented potentials if required Left mitral isthmus line Caval-Tricuspid Isthmus line

27 TYPE OF SURGICAL LESION or

28 Mini-invasive technique Right monolateral approach Thoracoscopy Mono/bipolar ablation Stable temperature 70 C «Suction» Mechanism TRANSMURALITY 28

29 Opening the pericardium Usually longitudinally opened 1 to 2 cm above the phrenic nerve Ports positioned in third, fourth, and fifth intercostal spaces of the right thorax Courtesy of Prof. Muneretto

30 Opening the transverse sinus Courtesy of Prof. Muneretto

31 Opening the oblique sinus Courtesy of Prof. Muneretto

32 Magnetic introducer inserction Through transverse sinus and oblique sinus Courtesy of Prof. Muneretto

33 Connection to the ablation probe Courtesy of Prof. Muneretto

34 PVs encircling (suction 500 mmhg) Stable suction and temperature (70 C) max. power 50 W per segment (6 segments) Bipolar / monopolar RF Courtesy of Prof. Muneretto

35 Left Atrium Ablation Stable suction and temperature (70 C) max. power 50 W per segment (6 segments) Bipolar / monopolar RF Courtesy of Prof. Muneretto

36 Right atrium / SVC ablation Courtesy of Prof. Muneretto

37 Check of conduction block Courtesy of Prof. Muneretto

38 GOAL: Atrial fibrillation termination

39 - 7 days Holter ECG - Implantable loop recorder - Patch (6 weeks)

40 Importance of post-procedure monitoring Success of 12 m. 88% (24-hour Holter) 74% (7-day Holter) Kottkamp, PACE 2004

41 Follow up:

42 89 pts with Persistent/Long Standing AF Male: 28 (31.5%) Mean age: 63.7 ± 10.3 years LA dimensions: 48,5 ± 3,7 mm Average AF Duration: 48 months

43 BASELINE CHARACTERISTIC Mean NYHA class 2,4 ± 0,7 Mean LVEF (%) 57 ± 9.5 Mean BMI (Kg/m 2 ) 27.6 ± 5.3 Hypertension (n) 52/89 ( 58.4%) Diabetes (n) 20/89 ( 22.5%) COPD (n) 7/89 ( 7.9%) Previous TIA / Stroke (n) 7/89 ( 7.9%) Previous Miocardial Infarction (n) 2/89 ( 2.3%)

44 Mean ablation time: 17 ± 5.5 min Mean overall procedural time: ± 60.4 min Entrance Block confirmed in 80 pts (89.8 %) Exit Block confirmed in 87 pts (97.7%)

45 EXIT BLOCK 20 poles electrode positionated in box area pacing No capture

46 Dissociated potentials ENTRANCE BLOCK

47 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% 1% 2% 0% 0% Conversion to ministernotomy PM implantation Mortality Major post-op complication Mean ICU Stay: 11.2 ± 6 hours Mean Hospitalization: 5.9 ± 3.8 days

48 EP Procedure needed in 8 (8.9%) pts 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% 4.4% 2.2% 1.1% 2.0% Cavo-Tric Isthmus Focal Triggers Gap CFAEs

49 RECURRENCES: are all really AF? Role of the EP mapping procedure in AF recurrences

50 RECURRENCE: Is this really AF? Role of the EP mapping procedure Coronary sinus 9-10 (septal origin)

51 Left atrial activation mapping Left atrium Left atrium Left Septum Right atrium

52 Right atrial activation mapping LA Right atrial septum: arrhythmia origin

53 Transcatheter ablation

54 100% 80% 60% 40% 20% 0% SR SR Free from AADs SR Free from ACs 6 Months 12 Months 24 Months

55 The combination of a surgical box lesion and transcatheter ablation in a hybrid approach provides excellent mid-term clinical outcomes in patients with persistent - longstanding, persistent AF and may be considered in the future one of the established treatment option for patients with persistent AF

56 MILAN 2015 MAY 1 st OCTOBER 31 st Thank you! mmoltrasio@ccfm.it

57 backup

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59 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Sinus Rhythm ADDs Free AC Free

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63 Electrical cardioversion ablation

64 ENTRANCE BLOCK (89.8%)

65 EXIT BLOCK (97.7%)

66 An AATS I m a surgeon Dr Moltrasio (electrophysiologist)