Ali Khoynezhad MD, PhD, FHRSDirector of Cardiovascular Surgery

MemorialCare Long Beach Medical CenterProfessor of Surgery

David Geffen School of Medicine at UCLALos Angeles, CA

Staged Hybrid Procedures

Disclosures

Relevant: AtricureConsultant/Speaker, national PI

NOT relevant:Medtronic,Vascutek, Edwards, St Jude Medical, Bard, Bolton

Thoracoscopic ablation

bilateral VATSbeating heart procedurebi-atrial lesion setRoof line and isthmus lesionbilateral ganglion-plexus ablationLAA exclusionconfirm exit/entrance blocks & confirm lack of ablation gaps

Intraoperative EP studyPre-ablation:

Sense (baseline PV potentials)Pace (find threshold for capture)HFS (GP activity: increase RR interval)

Post-ablation:Sense (inacive EKG)Pace (pace @ threshold for capture)HFS (no GP activity)

Proven Technology Platform:

Bipolar RF clamp Effectively and safely achieves complete, continuous lesions– Linear, continuous

transmural lesions– HRS recommended energy

source

Patient SelectionBetween 18 and 80 years of age with BMI < 30

Drug refractory or ablation-failed AF

Intolerant of anti-arrhythmic drugs or coumadin

EF ≥ 30%

TEE confirms lack of thrombus in the LAA

Left atrial size < 6 cm

Tolerant to single lung ventilation

Redo patients are relative contraindications

Midterm outcomes of Thoracoscopic Ablation of Atrial Fibrillation using Dallas Lesion set

Ali Khoynezhad MD, PhD, FACSProfessor of Cardiovascular Surgery

Director of Aortic SurgeryCo-Director, Atrial Fibrillation Program

Cedars-Sinai Heart InstituteLos Angeles, CA, USA

OBJECTIVE:

Atrial fibrillation (AF) is the most common sustained arrhythmia and is associated with a nearly five-fold increased risk for stroke as well as over two-fold increased risk of death.

For symptomatic drug-refractory AF, percutaneous ablation has been used with varying success and possible incomplete ablation lines.

AF is often combined with structural heart disease, but patients with lone AF are optimal candidates for the endoscopic ablation treatment.

While Cox-Maze IV is the gold standard for concomitant Maze, optimal approach for stand alone operations is not established. Thoracoscpopic Maze

We analyzed our data in endoscopically performed ablation of atrial fibrillation using Dallas Lesion set.

METHODS:

From January 2012 through January 2014, a total of 48 symptomatic and drug-refractory patients with lone atrial fibrillation underwent a thoracoscopic epicardial ablation using the bipolar radiofrequency clamp (AtriCure Inc.).

27 of these patients were performed using Dallas lesion sets on the beating heart. All of them had persistent long-standing AF. Epicardial ablation was performed on 19 men (70%) and 8 women (30%), with a mean age of 64

(range 47 to 82) years. Entrance and exit block were confirmed in all patients after Maze, and the left atrial appendage was

excluded.

RESULTS:

There were no hospital stroke, myocardial infarction or operative mortality. In two patients fem-fem cardiopulmonary bypass was used to fix a laceration of the left atrial

appendage and left atrium. No sternotomy or cardioplegic arrest was necessary. The follow-up was completed in 91% with a mean length of 13 months with a freedom of AF in

90%. The heart rhythm was documented in all of them besides 7 patients with a holder-ECG with

duration of at least of 7-days. In 2 patients the postoperatively persistent AF or flutter was treated with radiofrequency ablation. Pacemaker implantation was done in 3 patients (10%) due to bradycardia (n=2) and sick-sinus

syndrome (n=1). There were 2 late deaths (7%) one due to pulmonary embolism (PE) and non-AF related stroke.

CONCLUSIONS:

Thoracoscopic radiofrequency ablation using Dallas lesion set on the beating heart for treatment of lone atrial fibrillation is technical feasible, and achieves high success rates with low procedure-related morbidity.

Mid-term follow-up is encouraging with acceptable rate of EP re-intervention and pacemaker implantation.

Collaboration with electrophysiology colleagues is critical for optimal patient care. Long-term follow-up is needed!

Personal T-Ablation experience

122 patients (82% long-standing persistent afib)No procedural stroke, MI or deathPump-assisted in 3 pts, no sternotomyAverage hospital stay 3.4 daysOne pt died at six weeks of unrelated causemidterm f/u up to 25 months on 7/14-day HolterNine pts required atrial flutter/fibrillation ablation91% pts in NSR or paced sinus 81% off anti-arrhythmic ten pts have 1-45% AF burden at 1-year

First report of Hybrid AF ablation15 patients with persistent and longstanding persistent AF who failed AADs and at least one attempt at CA “Dallas” lesion set through a bilateral thoracoscopic approach CA followed 3-5 days later this lesion set, which confirmed the epicardial lines and ablated any gaps as well as residual and induced arrhythmia. freedom from atrial arrhythmia off AADs in the hybrid group at 20 months of follow-up (87% vs. 53%, p = 0.04). No complications

Mahapatra et al, Ann Thor Surg 2011

First Hybrid AF surgeon!

Source: The John Gibbon Lecturer American College of Surgeons

Results of Hybrid AF AblationAt one year, 22 of 24 (92%) patients were in sinus rhythm with no episode of AF, AFL or AT lasting longer than 30 seconds

None of those patients was on AAD and 5 (21%) patients were on coumadin

One-year success (freedom of AF/AFL/AT off AAD), was 93% for patients with paroxysmal AF and 90% for patients with persistent AF

Two (9%) of those 22 patients underwent CA for recurrent AF or left AFL after the hybrid procedure

Single-procedure success rate (sinus rhythm without AAD and/or redo procedure): 79% at 1 year for paroxysmal AF (11 out of 14 patients) and 90% for persistent AF (9 out of 10 patients) and overall single-procedure success rate of 83% at 1 year.

Pison et al, J Am Coll Cardio 2012;60:54-61

Literature on Hybrid AF Ablation

Literature on Hybrid AF Ablation

Maze and guidelines

HRS 2017

AATS 2017

STS 2017

CONVERGE IDE Study Convergence of Epicardial & Endocardial RF Ablation

for The Treatment of Symptomatic Persistent AFStudy Design

Multi-center, prospective, open label pivotal studyRandomized 2:1 (convergent procedure :

standalone irrigated RF endocardial catheter ablation) 27 US Sites, 3 OUS sites153 patientsPost procedure follow-up at 12 monthsLong-term monitoring follow-up at 18 monthsAnnual phone follow-up at years 2, 3, 4, 5.

Study StatusEnrollment Started January 2014

– 78 subjects treated as of 08/2017– Est. enrollment completion – 2018

Study Sponsor:AtriCure (formerly nContact Surgical, Inc.)

CONVERGEPrimary Effectiveness EndpointAF/AT/AFL free absent class I and III AADs except, a previously failed class I or III AAD with no increase in dosage through 12 months post procedureSecondary Effectiveness Endpoints

• Success or failure to achieve a 90% reduction from baseline AF burden and off all Class I and III AADs at 12 months post procedure

• Success or failure to achieve a 90% reduction from baseline AF burden regardless of Class I and III AADs at 12 months post procedure

• Change in QOL measures at 12 months post procedure from baseline• Change in 6 minute walk test score from baseline

Primary Safety EndpointIncidence of major adverse events (MAEs) within 30 days convergent procedure

CONVERGE IDE Study Convergence of Epicardial & Endocardial RF Ablation

for The Treatment of Symptomatic Persistent AF

DEEPDual Epicardial & Endocardial Procedure (DEEP) for Treatment of

Persistent and Longstanding Persistent AF with RF Ablation

Study DesignMulti-center, prospective, single arm study 23 US Sites, 2 OUS sites220 patientsStaged hybrid procedure

1. Surgical procedure is performed on day 12. Endocardial procedure performed 90 days later

Post epicardial procedure follow-up -12 mLong-term follow-up visits at years 2,3,4,5.

Study StatusEnrollment started Feb 2015

– 41 subjects enrolled as of 08/2017Study Sponsor:

AtriCure, Inc.

DEEPDual Epicardial & Endocardial Procedure (DEEP) for Treatment of

Persistent and Longstanding Persistent AF with RF Ablation

Primary Effectiveness EndpointAF/AT/AFL free absent class I and III AADs except, a previously failed class I or III AAD with no increase in dosage through 12 months post procedure

Secondary Effectiveness Endpoints• Acute procedural success of the epicardial and endocardial procedure• Change in QOL• Incidence of stroke

Primary Safety EndpointIncidence of serious adverse events (SAE) within 30 days of the epicardial surgical ablation procedure or within 7 days of the endocardial EP procedure

National PIs: Ellenbogen, Kasirajan, Khoynezhad

Staged DEEP Trial: EP Procedure

Endocardial Catheter Ablation performed by EP at Day 91 with a window period yet to be determined.

Comprehensive mapping to ensure effective conduction block, lesion gap closure (as needed), and the creation of the cavotricuspid isthmus lesions. If the subject has mitral isthmus dependent flutter, a mitral isthmus lesion is made.

EP testing of a DEEP patient

DEEPDual Epicardial & Endocardial Procedure (DEEP) for Treatment of

Persistent and Longstanding Persistent AF with RF Ablation

SITES PI’sAcademic Medical Center de GrootAlta Bates Summit Medical Center KhanAspirus Wausau Hospital Johnkoski/Rist Cedars-Sinai Medical Center WangGood Samaritan Hospital SmithMemorialCare Health System KhoynezhadOrlando Health HoffOSF Saint Anthony Medical Center FarokhiPinnacle Health Cardiovascular Institute Mumtaz/LinkSentara Norfolk General Hospital PhilpottSt. Helena Hospital DunningtonUniversity of Florida BeaverUZ Brussels La Meir

Virginia Commonwealth University Kasirajan/Ellenbogen

Dual Endocardial Epicardial Procedure (DEEP)

Staged Hybrid approach – the future?

Concomitant hybrid thoracoscopic Procedure

Staged hybrid ProceduresPro

Blanking period/Intraoperative entrance/exit block Hospital marginsfeedback to surgeonsEP work in LA minimalBetter results EP-surgeon interaction for at least 3 months per pt

CONTwo anesthesiaPatient recovery and complianceMulti-center data missing

Patient-centric Care!Collaborative (integrated) approach to patient care is critical to optimize successBuild an AF team approachSee patients together in Clinic (One-stop-Shop)Discuss complex advanced AF patientsPerform cases together (Hybrid)Follow-up after AF procedureManage postoperative medications

ConclusionsSurgical AF ablation remains the most

effective remedy for non-paroxysmal AFStaged Hybrid Maze is an attractive and

less-invasive alternative with promising and superior single-center results

Staged Hybrid Maze is undergoing multi-center trial with early results expected in 3-5 years

Team/integrated approach improves care of patients with non-paroxysmal AF

Thank you!