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
DISCLOSURES Consulting fees/honoraria: Medtronic, INC
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
J Am Heart Assoc 2013 Success @ 12 months (single procedure) Late SINGLE PROCEDURE success 67% 54% 52% 42% 53% 64%
J Am Heart Assoc. 2013 80% 50%
J Am Heart Assoc. 2013 41% persistent AF
Single Procedure Outcome (off drugs) 35.3 % @ 1 y. 28 % @ 2 ys. 16.8 % @ 5 ys.
Single Procedure Outcome Role of A-Fib termination
Circ Arr. E. 2015 Multiple Procedure Outcome 74 % @ 5 ys. 64 % @ 5 ys.
Persistent A-Fib: > 7 days Long-standing Persistent A-Fib: > 1 year
Multiple procedures outcome persistent vs long-standing persistent (AF>1 year) 42%
Voltage map after transcatheter PVI (1st procedure) Areas of isolation 1.5 mv 0 mv
Voltage map 6 months after PVI + endocardial BOX lesion (2 procedures)
RF Ablation of gaps (3 rd procedure)
Voltage map after third endocardial RF procedure
catheter surgery SURGERY?
catheter catheter surgery surgery
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
2005
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
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
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)
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
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
Controindication to AC therapy or no compliance Organic disease or disturbance of hemostasis Pregnancy, planned pregnancy od breastfeeding Concomitant cardiac surgery procedure planned
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
TYPE OF SURGICAL LESION or
Mini-invasive technique Right monolateral approach Thoracoscopy Mono/bipolar ablation Stable temperature 70 C «Suction» Mechanism TRANSMURALITY 28
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
Opening the transverse sinus Courtesy of Prof. Muneretto
Opening the oblique sinus Courtesy of Prof. Muneretto
Magnetic introducer inserction Through transverse sinus and oblique sinus Courtesy of Prof. Muneretto
Connection to the ablation probe Courtesy of Prof. Muneretto
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
Left Atrium Ablation Stable suction and temperature (70 C) max. power 50 W per segment (6 segments) Bipolar / monopolar RF Courtesy of Prof. Muneretto
Right atrium / SVC ablation Courtesy of Prof. Muneretto
Check of conduction block Courtesy of Prof. Muneretto
GOAL: Atrial fibrillation termination
- 7 days Holter ECG - Implantable loop recorder - Patch (6 weeks)
Importance of post-procedure monitoring Success of ablation@ 12 m. 88% (24-hour Holter) 74% (7-day Holter) Kottkamp, PACE 2004
Follow up:
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
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%)
Mean ablation time: 17 ± 5.5 min Mean overall procedural time: 136.1 ± 60.4 min Entrance Block confirmed in 80 pts (89.8 %) Exit Block confirmed in 87 pts (97.7%)
EXIT BLOCK 20 poles electrode positionated in box area pacing No capture
Dissociated potentials ENTRANCE BLOCK
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
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
RECURRENCES: are all really AF? Role of the EP mapping procedure in AF recurrences
RECURRENCE: Is this really AF? Role of the EP mapping procedure Coronary sinus 9-10 (septal origin)
Left atrial activation mapping Left atrium Left atrium Left Septum Right atrium
Right atrial activation mapping LA Right atrial septum: arrhythmia origin
Transcatheter ablation
100% 80% 60% 40% 20% 0% SR SR Free from AADs SR Free from ACs 6 Months 12 Months 24 Months
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
MILAN 2015 MAY 1 st OCTOBER 31 st Thank you! mmoltrasio@ccfm.it
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100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Sinus Rhythm ADDs Free AC Free
Electrical cardioversion ablation
ENTRANCE BLOCK (89.8%)
EXIT BLOCK (97.7%)
An electrophysiologist @ AATS I m a surgeon Dr Moltrasio (electrophysiologist)