CRYOABLATION&& WITH&NEW&GENERATION&BALLOONS&

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1 >&Klinikum Bogenhausen CRYOABLATION&& WITH&NEW&GENERATION&BALLOONS& Prof.&Dr.&med.&Ellen&Hoffmann& Heart&Center&Munich8Bogenhausen& Munich&Municipal&Hospital&Group& Klinikum&Bogenhausen& Munich,&Germany& Conflicts)of)interests)/)Disclosures:)) Honoraria&for&lectures:&Astra&Zeneca,&Boehringer&Ingelheim,&Boston&ScienUfic,&MSD&Sharp&&&Dohme&GMBH,&Medtronic&& Honoraria&for&advisory&board&acUviUes:&nothing&to&declare& ParUcipaUon&in&clinical&trials:&principle&invesUgator&FREEZE&Cohort&Trial,&conducted&by&IHF&Ludwigshafen,&supported&by&Medtronic& Research&funding:&Biotronik,&Edwards&,&Medtronic&GmbH,&Philips&GmbH,&St.&Jude&Medical&GmbH,&B.&Braun&AG,&Stentys&Inc.& Venice,&16.&Oct.&2015&

2 CRYOABLATION&& WITH&NEW&GENERATION&BALLOONS& cryoballon&ablauon:&2005&8&2015& technological&and&procedural&aspects& safety/efficacy&in&parox.&and&persist.&af&

3 200000& & & & & & 80000& 60000& 40000& 20000& 0& CRYOBALLOON&ABLATION:&2005&8&2015& 2015:&&&>1000&acUve&cryo&consoles&worldwide&&&&&>500&in&Europa&and&USA& proced.& 100& publica5ons) 85& 80& 72& 59& 60& 40& 33& 29& 30& 20& 0& 0& 2& 12&16& 0& 2005&2007&2009&2011&2013&2015& feasibility& van&belle&et&al.& Eur&Heart&J.,&2007& 10& 200& 1.800& 7.000& & & & 2005& 2006& 2007& 2008& 2009& 2010& 2011& 2012& 2013& 2014& 2015& CE:&& 1.&generaUon& cryoballon&& 2005) )2015))frequency)of)cryoballoon)abla5on) ) CryoCath&!&Medtronic&& & mulucenter&study& Neumann&et&al.&& JACC,&2008& Stop&AF& Packer&et&al.& JACC&2013& &US&FDA&& approval& 1.&gen.&CB& long8term&outcome& Vogt&et&al.&& JACC,&2013& 2.&generaUon& cryoballon & cryoballon&st& with&short&up & Data&on&publicaUons:&pubmed&analysis,&10/05/15& Data&on&file:&Medtronic&

4 %& 8& 7& 6& 5& 4& 3& 2& 1& 0& years& TRENDS&IN&COMPLICATIONS&FOR&AF&ABLATIONS& US&NaUonwide&InpaUent&Sample:&In8Hospital&ComplicaUons&Associated&With&CA&of&AF& between&2000&and&2010&&&&&n=&93,801&procedures& 8& 6& 4& 2& 0& %&of&complicauon& by&annual&operator&volume& <25& 25850& >50& any&procedural&& complicauons& 6.3%& cardiac&& complicauons& 2.5%& postop&stroke/tia& 1.0%& in8hospital&death& 0.42%& &&&&&&&!&n=394&deaths& 2000& 2001& 2002& 2003& 2004& 2005& 2006& 2007& 2008& 2009& 2010& overall&complicauon&rate:&6.3%&&&in8hospital&deaths:&394/93,801&(0.42%)&in&10&yrs& significant&associauon&between&operator/hospital&volume&and&adverse&outcomes&!&need&to&idenufy&the&safety&measures&in&af&ablauons&to&improve&overall&outcome& Deshmukh&et&al.,&Circ&11/2013&

5 CRYO:&MAJOR&COMPLICATIONS& Andrade&& Heart&Rhythm& 2011& meta&analysis& n=1,349& Vogt&& JACC&& 2012& single8center& n=605& Aryana&& JCE&epub&ahead& 2015& mulu8center& n=773& Hoffmann&& own&data& status&8/2015& single8center&& n=1472& Death) 0& 0& n/a& 0& AE)fistula) 0.00 & 0& n/a& 0& Tamponade) 0.57& 0.2& n/a& 0.2& Stroke)or)TIA) 0.32& 0.3& n/a& 0.2& Pers.PNP)<12)mon.) 4.7& 2.0& 1.2& 0.8& PNP)>12)mon.) 0.37& 0& n/a& 0.07& Other)major)AEs) 2& 2.2& 1.6& 0.8& Total) 3.2%) 4.7%) ) 2.8%) 2.0%) FDA&data&4/15:&7&atrio8esophageal&fistulas&with&2nd&CB&/&100,000&ablaUon&!&1:14.000& low&major&complicauon&rate&in&cryoballoon&ablauon&&

6 ADVANCES&IN&CRYOBALLOON8TECHNOLOGY & 1 st )Gen.:)Arc5c)Front )& Refrigerant&spray&palern& with&4&jets&close&to&the& equator& Surface&temperature& gradient& Cooling&zone&and&posiUoning& COAXIAL& CB sheath mapping catheter carina NON8COAXIAL&& CB sheath carina 2 nd )Gen.:)Arc5c)Front)Adv. ) More&uniform&spray&palern&& with&8&more&distal&jets&& Increased&flow&+16%&(28&mm)& launched&5/2012& by&courtesy&of&medtronic,&inc.& cooling)zone) 1 st &generauon& 2 nd &generauon& Straube&,&Hoffmann&et&al.&for&the&FREEZE&Cohort&Invest.,&Europace&2014& more&uniform,&extended&freezing&zone&at&the&distal&balloon&hemisphere& need&for&coaxial&alignment &!&contact&of&the&opumal&freezing&zone&even&in&difficult&anatomies&

7 CRYOBALLOON&ABLATION&FOR&PVI& WITH&REAL8TIME&PV8POTENTIAL&RECORDING&AS&A&PREDICTOR&OF&EFFICACY& IsolaUon&of&LS8PV& CB&28&mm,&spiral&mapping&catheter&& Ø&1.1mm,&8&electrodes,&20mm&loop& I& V1& V6& DETERMINATION&OF& TIME&TO&PV&ISOLATION&(TTI) & ICE&& in&ra& ET& &probe& steerable& &sheath& spiral&& mapping& CB& CS& over&the&wire&balloon&technique& 8,1& 7,8& 5,6& 4,5& 3,4& 2,3& 1,2& 1,2& 3,4& CS) * start 1 st ablation & * 21 sec delay * * * * *&PV&spike& 32 sec isolation 2nd&gen.&CB&!&single8shot&in&70%&of&veins,&TTI &!&predicuve&for&durable&pvi& Straube,&Hoffmann&et&al.,&Circ&AEP,&2014&

8 2nd&GENERATION&CRYOBALLON&WITH&SHORTENED&TIP& PRELIMINARY&PROCEDURAL&RESULTS& AFA8ST:&distal&Up&840%&in&length,&no&change&in&flowrate&!&aim:&to&obtain&online&PV&potenUals&during&ablaUon&more&frequently& ArcUc&Front&Advance& &(AFA)& n&=&34&pts.&/&136&pv& feasibility&to&determine&the&tti& n=68&pv& n=68&pv& 0.76& ArcUc&Front&Advance&ST& &(AFA8ST)& short&up&of&the&cryoballoon&!&posiuoning&of&the&spiral&mapping&more&osual&& high&rate&of&online&pv&potenual&recordings,&unul&now&no&stausucal&difference& Bunz,&Hoffmann&et&al,&DGK&Berlin,&abstract,&10/09/15&

9 66%& 64%& 81%& 69%& 64%& 84%& 84%& 82%& 91%& 90%& 80%& 83%& 85%& 85%& 80%& 82%& 86%& 0%& 20%& 40%& 60%& 80%& 100%& DiGiovanni&& (n=100)& Fürnkranz&& (n=105)& Aryana& &(n=340)& Aytemir& (n=306)& Greiss& (n=376)& Metzner& &(n=49)& Chierchia&& (n=42)& Kumar&& (n=40)& Jourda&& (n=75)& Ciconte& (n=143)& Wissner& (n=45)& Hoffmann& (n=181)& p=0.012& p=0.012& p=ns& p=0.008& p=0.038& cryoballon&1st&generauon& Freedom&from&AF&(%)& 2nd&generaUon&cryoballon&!&success&rate&& 15% && reproducible&and&consistent&results&among&different&centers&>80%& 2nd&generaUon& OUTCOME&OF&CRYOABLATION&STUDIES& IN&PAROXYSMAL&AF&AT&1&YEAR!

10 PATIENTS&WITH&ALL&VEINS&ISOLATED&AFTER&THE&INTITIAL&& RF&OR&CB&ABLATION&AT&SCHEDULED&REMAP& consecuuve&invasive&lez&atrial&remap&3&mon.&azer&pvi&irrespecuvely&of&symptoms& %&pts&with&all&pvs&isolated&azer&the&1 st &procedure& 100%& 80%& 60%& RF& +contact& 63%& Cryoballon&& 1.G& 67%& 2.G& 78%& 40%& 20%& 30%& 23%& 8%& 35%& FU&mon.&& bis&remap& 0%& GAP8AF& 1& Willems& 2& Jiang& 3& EFFICAS&I& 4& EFFICAS&II& 7& Ahmed& 5& Reddy& (n=117)& (n=40)& (n=75)& (n=26)& (n=24)& (n=12)& (n=21)& 3& 3& 12& 3& 3& 3& 3,4& cryoballoon:&high&rate&of&durable&isolated&veins&azer&the&iniual&ablauon& contact&force&sensing&rfa&!&efficacy & 6& 1 Late&Breaking&Clinical&Trials&session&I&at&the&EHRA&EUROPACE&2013&meeUng&in&Athens,&Greece& 2 &Williems,&et&al.&J&Cardiovasc&Electrophysiol&2010;&21(10): & 3 &Jiang,&et&al.&Heart&Rhythm.&& 2014& 4& Neuzil&et&al.&Circ&Arrhythm&Electrophysiol.&2013&& 5,& &Ahmed,&et&al.&J&Cardiovasc&Electrophysiol,&2010;&Reddy&et&al.,&JCE&2015,& 7 &&Kautzner&et&al.,&Europace&2015&&

11 EVALUATION&OF&DIFFERENT&CRYO8DOSING&PROTOCOLS& WITH&AND&WITHOUT&A&BONUS&APPLICATION&AFTER&ACUTE&PVI& 100%& 80%& 60%& 82%& 240s&w/o&bonus& 72%& 82%& FREEDOM&FROM&AF/AT& 71%& 180s&w/&bonus& 82%& 95%& 84%& 180s&& w/o&bonus& 86%& 40%& 20%& 0%& Tebbenjohanns*&& (n=33)& Mondesert&& (n=85)& Wissner& (n=38)& Nölker&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& Chierchia&& Kenigsberg& Straube&& Ciconte&& (n=47)& (n=52)& (n=43)& (n=57)& (n=50)& FU&mon.& & 7 cryo&ablauon&ume &+/8&bonus&appl.&!&no&effect&on&freedom&from&AF& however:&short&follow8up,&no&informauon&on&reconducuon,&small&sample&size&

12 CONTACT&FORCE&RF&VS.&CB&PVI:&EFFICACY&AND&SAFETY& & prosp.&mulucentre&(4)&observ.&study&&n=376&paf&pts.,&59.8&yrs&&&&26%&female& contact&force&rf&n=198&&&cryoballoon&&n=178& freedom&from&atrial&arrhythmias& CF8RF&76%& p=0.63& &cryo& 73.3%& 200& 180& 160& 140& 120& 100& 80& 60& 40& 20& 0& p=0.003& 122.5& 109.6& 19.3& 17.6& 42.7& 48.5& procedure&ume& (min.)& procedural&characterisucs& p=0.10& fluoroscopy&(min.)& p=0.22& x8ray&exposure& (Gyxcm2)& complica5ons) CFYRF) cryoabla5on) p)value) total) 7.1%& 7.3%&incl.&5.6%&trans.PNP& 0.93& severe) 2&embolic&ev.&&1%&&&&&2&tamp.&1%&&&&&1&esoph.les.&0.5%& none& 0.03& CF8RF&and&2 nd &gen.&cryoablauon&!&comparable&efficacy& severe&complicauons&more&frequently&observed&with&cf&rf& Squara&et&al,&Europace&2015&

13 RF&STRATEGIES&FOR&PERSISTENT&AF& Substrate&and&Trigger&AblaUon&for&ReducUon&of&AF& first&procedure,&drug&refractory&pers.&af:&n=589&pts.,&48&centers,&12&countries& randomized&& 1:4:4& FREEDOM&FROM&AF&>30s& &SINGLE&PROCEDURE&SUCCESS&& 3!strategies! PVI&only& PVI&+&lines& PVI&+&CFAE& 59&%& 49&%& 46&%& Verma&et&al.&,&NEJM&May&7&&2015& persistent&af:& PVI&only &is&a&reasonable&strategy&for&the&index&procedure&

14 ABLATION&LESION&ZONE&WITH&2 ND &GEN.&CRYOBALLOON& 3D&electroanatomic&voltage&map&pre8&and&post8&PVI,&&merge&with&CT&scan& n=43&pauents& 95%&freedom&from&AF&& at&6&months& LA&post.&wall:&& 73%&ablated& 28mm&cryoballoon:&wide&antral&ablaUon&lesion&at&the&LA&posterior&wall& &partly&explains&the&efficacy&beyond&pv&isolauon& Kenigsberg,&Heart&Rhythm&2015&

15 CRYOABLATION&IN&PERSISTENT&AF:&SINGLE&PROCEDURE&SUCCESS& n&=&173&consec.&pts.&w/&refract.&pers.&af,&64&yrs,&la&46±7&mm,&ef&54%,&hhd&24%,&struct.&hd&27%& AF&duraUon&29&mon.&(IQR&12867)&&&&no.&cardioversions&&&2.4±1.6&& [%]& Freedom&from&AF/AT&or&symptoms& 82% FU:&1,&3,&6,&9,&12,&18,&24&mon.& &&&&&&&ECG,&holter,&symptoms& 59% 2.&generaUon& cryoballoon& pts.&&&&&&&&[n=]&&&&&&&157&&&&&&&&&&&153&&&&&&&&&&148&&&&&&&&&&&&141&&&&&&&&&&&&132&&&&&&&&&&&&68&&&&&&&&&&&&50& AAD&[%]&&&&&&&&&&&&&&&66%&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&17%&&&&&&&&&&&&&&&&&&&&&&&&&&&&6%& 2 / 3 &amiodarone& FU&[months]& Cryoballoon&ablaUon&for&persist.&AF&=&safe&and&effecUve&strategy&for&the&inUal&procedure& Straube,&Hartl,&Dorwarth,&Hoffmann&et&al.,&submiled&for&publicaUon&

16 CRYO8&AND&RADIOFREQUENCY&ABLATION&OF&AF& ONGOING&STUDIES&COMPARING&CRYO&AND&RF& & FIRE&AND&ICE&STUDY& PI:&Karl8Heinz&Kuck& ProspecUve&&randomized&and&mulU8 nauonal&comparison&(paf)& FREEZE&COHORT&STUDY& PI:&Ellen&Hoffmann&& ProspecUve&cohort&comparaUve& effecuveness&&trial&(parox.,&persist.)& randomizauon& RF&(n=&384)& Cryo&(n=&384)& RF&(n=&2000)& Cryo&(n=&2000)& status!! 8/2015! efficacy&and&safety&at&1&year& n!=!768!(100%)! inclusion!completed! FU!ongoing! efficacy&and&safety&at&1&year& funded&by&medtronic&

17 MULTINATIONAL&FREEZE&COHORT&STUDY& CRYO8&VS.&RF8ABLATION& 1.&AF&AblaUon,&parox.&AF&or&persist.&AF&with&prior&AAD& ProspecUve&comparaUve&effecUveness& cohort&trial&(parox.,&persist.),&itt& status:&06/10/2015& RF&(n=&2000)& Cryo&(n=&2000)& prim. endpoint: freedom from AF/AT at 1 year efficacy,&proc.&parameters,&complicauons experienced&centers& &50&RF&or& &50&Cryo&prior&to&parUcipaUon& 40&acUve&centers:&18&RF,&22&Cryo& Cohort ITT Cryo: 2049 RF: ,000 patients at the end of 2015 Total: 3855 total 1552 Austria,)China,)Germany,)Greece,)Netherlands,)Poland,)South)Africa,)Spain,)US)) Principle Investigor: Ellen Hoffmann supported&& by&medtronic& Freeze Plus Registry Cryo 579 RF 973

18 CRYOABLATION&& WITH&NEW&GENERATION&BALLOONS& &&&&&&&&&&&open&quesuons& & & & & & &&&&&&&&&&procedural&param.:&bonus&freeze?,&384&min&appl.&ume?&&&&&& preferenual&technique&for&the&index&proc.:&cryo&vs.&rf?& &&&&&&&&& &results&from&the&fire&ice&and&freeze&cohort&study & persistent&atrial&fibrillauon& & & & & & & &cryoballoon:&reasonable&opuon&for&the&index&procedure& & &&&&&&&&&&&&& &high&rate&of&durable&pvi& & & & & &wide&antral&ablauon&lesion,&fast&procedure& & & &&&&&&safety&and&efficacy & &&&&&&&10&years&of&cryoballoon&ablaUon:&evidence,&acceptance &&& & &&&&&&&complicauons,&reproducible&and&consistent&results &&