Stefano Nardi, MD, PhD

AZIENDA OSPEDALIERA SANTA MARIA TERNIAZIENDA OSPEDALIERA SANTA MARIA TERNIDIPARTIMENTO CARDIOTORACOVASCOLAREDIPARTIMENTO CARDIOTORACOVASCOLARE STRUTTURA COMPLESSA DI CARDIOLOGIA STRUTTURA COMPLESSA DI CARDIOLOGIA

UNITA’ OPERATIVA DI ARITMOLOGIA CARDIACA UNITA’ OPERATIVA DI ARITMOLOGIA CARDIACA LABORATORIO DI ELETTROFISIOLOGIA ED ELETTROSTIMOLAZIONE LABORATORIO DI ELETTROFISIOLOGIA ED ELETTROSTIMOLAZIONE

Segmental Ostial Catheter Ablation (SOCA) of AFib using Segmental Ostial Catheter Ablation (SOCA) of AFib using virtual geometry reconstruction with NavX system. virtual geometry reconstruction with NavX system.

The TERNI (Terni Evaluation ofThe TERNI (Terni Evaluation ofPulmonaRy Vein IsolatioN with EnSIte System) registryPulmonaRy Vein IsolatioN with EnSIte System) registry

Atrial Fibrillation MechanismsAtrial Fibrillation Mechanisms

SUBSTRATO GANGLI VAGALI

meccanismi operativi

RF

TRIGGERS

ROTORI

triggers dalle Vene Polmonari

Haissaguerre, NEJM ‘’98

Firing VPSL

RF

Dominant source of triggers Dominant source of triggers Role in the maintenanceRole in the maintenance• Firiing focali a scarica continua Firiing focali a scarica continua (Ja(Jaïïs)s)

• Firiing focali intermittenti Firiing focali intermittenti (O’Donnell, Kumagai, (O’Donnell, Kumagai, Oral)Oral)

• Rientro Rientro (Arora, Hocini, Wu, Mansour, Jais)(Arora, Hocini, Wu, Mansour, Jais)

HwangCirculation 2000

fibre critichefibre critiche

Sueda Sueda Ann Thorac Surg Ann Thorac Surg

19971997

Microcircuti Microcircuti di rientrodi rientro

HaissaguerreNEJM 1998

triggers dell’FAtriggers dell’FA

Electro-physiologic ApproachSOCA of all 4 veins

Pulmonary vein anatomy the 1st challenge

Left common trunk 3 right lower veins

Normal

Pulmonary vein anatomy the 1st challenge

Hocini M, Card. Res ’02 Hocini M, Circulation ‘02

The Antral Zonethe 2nd challenge

The Antral Zonethe 2nd challenge

Atrial Fibrillation ablationAtrial Fibrillation ablationanalisi Vene Polmonarianalisi Vene Polmonari

Virtual geometry reconstructionVirtual geometry reconstruction

Virtual geometry reconstructionVirtual geometry reconstruction

Virtual geometry reconstructionVirtual geometry reconstruction

What is success?

• Complete freedom of AF, off drug RX?• No symptoms, but drug Rx required?• Dramatic decrease in symptoms, but AADs

still required?• QoL• How do we detect asymptomatic episodes?• Anticoagulation ………………...?

QUESTIONSQUESTIONS

Esophageal contiguity with LA3D mapping system in AFib3D mapping system in AFib

Atrial Fibrillation approachAtrial Fibrillation approach

Ernst, JACC ‘03Ernst, JACC ‘03

Complete LesionsComplete LesionsA – 5% A – 5% B – 21% B – 21% C – C – 50% 50% D - 58-65% D - 58-65%OutcomeOutcome

• Complete lesion 74% Complete lesion 74% arrhythmia free w/o AADs arrhythmia free w/o AADs

• Incomplete lesion – almost Incomplete lesion – almost all recurrent arrhythmia all recurrent arrhythmia

Limitation of CLAALimitation of CLAA

• SEVERAL GAPS can be found within the ablation lines (2-4mm) exploring the “encircling line”.

• Studi recenti hanno dimostrato che FASCI di MUSCOLATURA PARIETALE presenti nella TONACA MEDIA delle VP possono rappresentare una sorgente dominante d’innesco (TRIGGER) della FA nell’uomo

• Evidenza indiretta a favore della presenza di SORGENTI MULTIPLE nelle diverse VP e nel contesto della vena singola

Innesco dell’FAInnesco dell’FAInnesco dell’FAInnesco dell’FA

Triggers dell’FA

Mantenimento Mantenimento dell’FAdell’FA

Mantenimento Mantenimento dell’FAdell’FA

Rimodellamento Rimodellamento atrialeatriale

Rimodellamento Rimodellamento atrialeatriale

Atrial Fibrillation ablationAtrial Fibrillation ablationtranseptal puncturetranseptal puncture

Atrial Fibrillation ablationAtrial Fibrillation ablationtranseptal puncturetranseptal puncture

Atrial Fibrillation ablationAtrial Fibrillation ablationtranseptal puncturetranseptal puncture

Atrial Fibrillation ablationAtrial Fibrillation ablationtranseptal puncturetranseptal puncture

Atrial Fibrillation ablationAtrial Fibrillation ablation

Atrial Fibrillation ablationAtrial Fibrillation ablation

Atrial Fibrillation ablationAtrial Fibrillation ablationAnatomical considerations (fluoro)Anatomical considerations (fluoro)

Atrial Fibrillation ablationAtrial Fibrillation ablationtranseptal puncture (fluoro)transeptal puncture (fluoro)

Atrial Fibrillation ablationAtrial Fibrillation ablationtranseptal puncture (fluoro)transeptal puncture (fluoro)

Atrial Fibrillation ablationAtrial Fibrillation ablationtranseptal puncture (fluoro)transeptal puncture (fluoro)

Atrial Fibrillation ablationAtrial Fibrillation ablationtranseptal puncture (fluoro)transeptal puncture (fluoro)

Atrial Fibrillation ablationAtrial Fibrillation ablationTEE evaluationTEE evaluation

Atrial Fibrillation ablationAtrial Fibrillation ablationTEE evaluationTEE evaluation

Atrial Fibrillation ablationAtrial Fibrillation ablationTEE evaluationTEE evaluation

Inferomediale

Infero-laterale

VPIL

VPSL

VP s

up.

lat.

VP inf

. lat

.

VP s

up.

set.

VP inf

. s

et.

Atrial Fibrillation ablationAtrial Fibrillation ablationvirtual geometry reconstructionvirtual geometry reconstruction

CT/MRI Scanner

DICOM 3 Slice Data

Worstation

Segmented 3D ModelSegmentation Module

User Interface

Atrial Fibrillation ablationAtrial Fibrillation ablationvirtual geometry reconstructionvirtual geometry reconstruction

Atrial Fibrillation ablationAtrial Fibrillation ablationvirtual geometry reconstructionvirtual geometry reconstruction

Point-by-Point

Medium-Low

Atrial Fibrillation ablationAtrial Fibrillation ablationvirtual geometry reconstructionvirtual geometry reconstruction

Atrial Fibrillation ablationAtrial Fibrillation ablationvirtual geometry reconstructionvirtual geometry reconstruction

Atrial Fibrillation ablationAtrial Fibrillation ablationvirtual geometry reconstructionvirtual geometry reconstruction

LSPV-LAA Junction

LA Medial-RPV Junction

RPV Carina

Atrial Fibrillation ablationAtrial Fibrillation ablationvirtual geometry reconstructionvirtual geometry reconstruction

Circumferential lesion pathway

PVPs

Atrial potentials

Lesion Validation (Preablation)Lesion Validation (Preablation)

Incomplete lesion

Lesion Validation Lesion Validation ((AblationAblation))

Complete lesion

Lesion Validation Lesion Validation ((AblationAblation))

Atrial potentials breakdown

PVPs disappearance

Lesion Validation Lesion Validation ((PVPs PVPs AbolitionAbolition))

≤ 0.1mV

≤0.05mV

Validazione delle lesioniValidazione delle lesioni ((abbattimento dei abbattimento dei potenzialipotenziali))

Circumferential lesion pathway

Type A AF (PV Tachycardia)

AF waves

Lesion Validation (Preablation)Lesion Validation (Preablation)

Incomplete lesion

Type A AF (PV Tachycardia)

Lesion Validation (Lesion Validation (AblationAblation))

Complete lesion

Lesion Validation (Lesion Validation (AblationAblation))

Atrial activity reduction

Type A AF (PV Tachycardia)

Abolition

Lesion ValidationLesion Validation Type A AF/PV Tachycardia AbolitionType A AF/PV Tachycardia Abolition

≤ 0.1mV

≤0.05mV

Validazione delle lesioniValidazione delle lesioni (abbattimento dei (abbattimento dei

potenziali)potenziali)

REGISTRO OSSERVAZIONALE

T.E.R.N.I.

AZIENDA OSPEDALIERA SANTA MARIA TERNIAZIENDA OSPEDALIERA SANTA MARIA TERNIDIPARTIMENTO CARDIOTORACOVASCOLAREDIPARTIMENTO CARDIOTORACOVASCOLARE STRUTTURA COMPLESSA DI CARDIOLOGIA STRUTTURA COMPLESSA DI CARDIOLOGIA

UNITA’ OPERATIVA DI ARITMOLOGIA CARDIACA UNITA’ OPERATIVA DI ARITMOLOGIA CARDIACA LABORATORIO DI ELETTROFISIOLOGIA ED ELETTROSTIMOLAZIONE LABORATORIO DI ELETTROFISIOLOGIA ED ELETTROSTIMOLAZIONE

Procedure (min): 148±26 144±24 151± 29

Fluoroscopy (min): 59±17 58±16 66±19

Mapping (min): 35±8 33±9 38±4

Nr. Pulses of RF: 72±16

70±17 75±19

RESULTSRESULTS Global Pz.in SR Pz. in AF

TERNI RegistryTERNI Registry

629 VP treated (145 pts)

Acute Complete BlockAcute Complete Block

558 VP (89%)558 VP (89%)

Incomplete BlockIncomplete Block

71 VP (11%)71 VP (11%)

• 422 pts with symptomatic PaAF and PeAF referred to us between July ‘04 and September ’06. CA performed in 145/422 pts (34%).

TERNI registryTERNI registry

• At least one MONTHLY episode of Persistent symptomatic AF

• At least ONE WEEKLY episode of PaAF or PeAF

• At least Two or More AADs unable to control symptoms

• Age >75 yrs• Contraindications to ACT• Congestive HF• NYHA class III or IV• LVEF ≤35% • LA diameter ≥55mm• CARDIAC THROMBUS• Life expectancy <1 yr• CCH surgery <3 mo or

PROSTHETIC valves

Inclusion criteriaInclusion criteria Exclusion criteriaExclusion criteria

AFib PAROX. PERSIST. TOTALPatients 91 54 145 Age 62±13 67±8 64±15Sex (M/F) 61/26 37/21 98/47Duration 36±12N.episodes/mo 4±6LVEF (%) 55±6 51±9 53±9,7LA diameter 44±8 47±8 46±8CAD 15 21 36

TERNI registryTERNI registry

• NO major complication (including death, stroke or other thromboembolic events) observed.

• MILD pericardial effusion observed in 4 pts.

• ANGIOGRAFIC analysis of all PVs performed post- procedure in all pts (no PV stenosis).

Clinical OUTCOME

TERNI RegistryTERNI Registry

• TELEMETRY MONITORING from 24 to 36 hr. • Eparin Na+ iv for 24 to 36 h.• ACT started 24 h post RFCA • ECHO pre-discharge.• Discharged with ACT (maintained for ≥ 6 mo)• Discharged with AADs (maintained for ≥ 6 mo) (35% with propafenone and 65% with flecainide)

Post-ablation MANAGEMENT TERNI RegistryTERNI Registry

• After a mean FU Overall FREEDOM FROM AF (both PaAF and PeAF) was 60% (69% and 48%), w/o AADs and 72% (80% and 55%) with previous ineffective AADs.

Clinical OUTCOME

• The Kaplan-Meier statistical analysis probability of freedom from arrhythmia was maximal at 12 months

TERNI RegistryTERNI Registry

• Among UNIVARIATE predictors, the variables of age, sex, duration and frequency of AF, LVEF, LA size and structural heart disease, this approach revealed that an increased LA SIZE >50mm is an indipendet predictor of AF recurrence

TERNI RegistryTERNI Registry

• NO major complication (including death, stroke or other thromboembolic events) observed.

• MILD pericardial effusion observed in 4 pts.

• ANGIOGRAFIC analysis of all PVs performed post- procedure in all pts (no PV stenosis).

Clinical OUTCOME

TERNI RegistryTERNI Registry

• TELEMETRY MONITORING from 24 to 36 hr. • Eparin Na+ iv for 24 to 36 h.• ACT started 24 h post RFCA • ECHO pre-discharge.• Discharged with ACT (maintained for ≥ 6 mo)• Discharged with AADs (maintained for ≥ 6 mo) (35% with propafenone and 65% with flecainide)

Post-ablation MANAGEMENT TERNI RegistryTERNI Registry

• After a mean FU Overall FREEDOM FROM AF (both PaAF and PeAF) was 60% (69% and 48%), w/o AADs and 72% (80% and 55%) with previous ineffective AADs.

Clinical OUTCOME

• The Kaplan-Meier statistical analysis probability of freedom from arrhythmia was maximal at 12 months

TERNI RegistryTERNI Registry

• Among UNIVARIATE predictors, the variables of age, sex, duration and frequency of AF, LVEF, LA size and structural heart disease, this approach revealed that an increased LA SIZE >50mm is an indipendet predictor of AF recurrence

different Technologiesdifferent Technologies

MappingMapping• Point by pointPoint by point

• LassoLasso• SpiralSpiral• BasketBasket

TrackingTracking• XrayXray

• CARTOCARTO• LocaLisaLocaLisa• NavXNavX• RPMRPM

• ICEICE

AblationAblation• ConventionalConventional

• 8 mm tip8 mm tip• Irrigated tipIrrigated tip• InvestigationalInvestigational(balloon, cryo...)(balloon, cryo...)- Framework for ablationFramework for ablation

- Mapping guidanceMapping guidance

- Anatomic localizationAnatomic localization

- Tagging of ablation sites- Tagging of ablation sites- Determine Determine catheter contactcatheter contact

- Improved Improved efficiency of efficiency of power deliverypower delivery

Atrial Fibrillation approachAtrial Fibrillation approach

• 422 pts with symptomatic PaAF and PeAF referred to us between July ‘04 and September ’06. CA performed in 145/422 pts (34%).

TERNI registryTERNI registry

• At least one MONTHLY episode of Persistent symptomatic AF

• At least ONE WEEKLY episode of PaAF or PeAF

• At least Two or More AADs unable to control symptoms

• Age >75 yrs• Contraindications to ACT• Congestive HF• NYHA class III or IV• LVEF ≤35% • LA diameter ≥55mm• CARDIAC THROMBUS• Life expectancy <1 yr• CCH surgery <3 mo or

PROSTHETIC valves

Inclusion criteriaInclusion criteria Exclusion criteriaExclusion criteria

AFib PAROX. PERSIST. TOTALPatients 91 54 145 Age 62±13 67±8 64±15Sex (M/F) 61/26 37/21 98/47Duration 36±12N.episodes/mo 4±6LVEF (%) 55±6 51±9 53±9,7LA diameter 44±8 47±8 46±8CAD 15 21 36

TERNI registryTERNI registry

evolution of 3D mapping systemAtrial Fibrillation approachAtrial Fibrillation approach

Procedure (min): 148±26 144±24 151± 29

Fluoroscopy (min): 59±17 58±16 66±19

Mapping (min): 35±8 33±9 38±4

Nr. Pulses of RF: 72±16

70±17 75±19

RESULTSRESULTS Global Pz.in SR Pz. in AF

TERNI RegistryTERNI Registry

629 VP treated (145 pts)

Acute Complete BlockAcute Complete Block

558 VP (89%)558 VP (89%)

Incomplete BlockIncomplete Block

71 VP (11%)71 VP (11%)