Vorhofflimmern: Verschluss des Vorhofsohres statt Antikoagulation : eine Option für jedermann?

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1 Vorhofflimmern: Verschluss des Vorhofsohres statt Antikoagulation : eine Option für jedermann? Fragen beim Patienten mit Vorhofflimmern: 1. wie gross ist das Risiko der Embolie aus dem Vorhofsohr? Wie häufig sind andere Ursachen? 2. Wieviele Patienten setzen die OAK ab? 3. Was ist besser OAK oder Schirm? Christoph Scharf PD Dr. med FMH Kardiologie spez. Rhythmologie HerzGefässZentrum Klinik im Park Seestr 220, 8027 Zürich

2 Anatomie des Vorhofsohres Kontrastmittelinjektion Nach 5 min Viele Taschen und Säcke, in denen das Blut liegen bleibt.

3 84% mit ACM Heart Rhythm2014;11:2 7 Quartilen der Mikroläsionen 1 Weiss < 6 2. Grau Dunkelgrau Schwarz > 44 A B C D

4 Yamamoto et al, Circ Cardiovasc Imaging. 2014;7:337-43

5 Ein Pat. mit VoFli hat stroke Wie gross ist die Wahrscheinlichkeit für eine cerebrovaskuläre Ursache des Stroke? 10%? 30%? 50%? 70%?

6 Stroke und Vorhofflimmern : andere Ursachen Briefly, atherothrombosis is diagnosed when a patient has intra- or extracranial atherosclerosis of the relevant artery, which is correlated with the patients symptoms and signs with ischaemic lesions on brain imaging studies. All patients enrolled for this study had AF; therefore, a stroke subtype in each patient was either cardioembolism or stroke of more than two causes (atherothrombosis plus cardioembolism)

7 CE Mark 2005.Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Information not intended for use or distribution in France. Stroke bei Vorhofflimmern: andere Ursachen SH AA MAY2015

8 CE Mark 2005.Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Information not intended for use or distribution in France. Stroke bei Vorhofflimmern: andere Ursachen 780 Patienten mit Stroke und VoFli Cerebrovaskuläre Läsion in 30% < SH AA MAY2015

9 Vorhofflimmern: Verschluss des Vorhofsohres statt Antikoagulation : eine Option für jedermann? Fragen beim Patienten mit Vorhofflimmern: 1. wie gross ist das Risiko der Embolie aus dem Vorhofsohr? Wie häufig sind andere Ursachen? 2. Wieviele Patienten setzen die OAK ab? 3. Was ist besser OAK oder Schirm? Christoph Scharf PD Dr. med FMH Kardiologie spez. Rhythmologie HerzGefässZentrum Klinik im Park Seestr 220, 8027 Zürich

10 VoFLi und Antikoagulation : je höher das Embolie- Risiko desto weniger Gebrauch! p < Piccini. Heart Rhythm (2012) > Medicare Patienten

11 Stroke risk assessment in AF CHA 2 DS 2 VASc Vascular stroke HAS-BLED Age Hypertension Diabetes 1 1 Stroke Vascular disease 1 1 Heart failure 1 (1) (1) Sex 1

12 VIT K-Antagonisten in Europa 25% - 30% INR nicht therapeutisch! (PREFER in AF Registry)

13 Auch NOAC werden bei 25% der Pat. abgesetzt! Medikament Study Drug Discontinuation Rate Major Bleeding (rate/year) Rivaroxaban 1 24% 3.6% Apixaban 2 25% 2.1% Dabigatran 3 (150 mg) Edoxaban 4 (60 mg / 30 mg) 21% 3.3% 33 % / 34% 2.8% / 1.6% Warfarin % % 1 Connolly, S. NEJM 2009; 361: years follow-up (Corrected); 2 Patel, M. NEJM 2011; 365: years follow-up, ITT. 3 Granger, C NEJM 2011; 365: years follow-up. 4 Giugliano, R. NEJM 2013; 369(22): years follow-up.

14 Auch NOAC werden bei 25% der Pat. abgesetzt! Medikament Study Drug Discontinuation Rate Major Bleeding (rate/year) Rivaroxaban 1 24% 3.6% Apixaban 2 25% 2.1% Dabigatran 3 (150 mg) Edoxaban 4 (60 mg / 30 mg) 21% 3.3% 33 % / 34% 2.8% / 1.6% Warfarin % % 1 Connolly, S. NEJM 2009; 361: years follow-up (Corrected); 2 Patel, M. NEJM 2011; 365: years follow-up, ITT. 3 Granger, C NEJM 2011; 365: years follow-up. 4 Giugliano, R. NEJM 2013; 369(22): years follow-up.

15 Vorhofflimmern: Verschluss des Vorhofsohres statt Antikoagulation : eine Option für jedermann? Fragen beim Patienten mit Vorhofflimmern: 1. wie gross ist das Risiko der Embolie aus dem Vorhofsohr? Wie häufig sind andere Ursachen? 2. Wieviele Patienten setzen die OAK ab? 3. Was ist besser OAK oder Schirm? Christoph Scharf PD Dr. med FMH Kardiologie spez. Rhythmologie HerzGefässZentrum Klinik im Park Seestr 220, 8027 Zürich

16 Watchman occluder (Boston Scientific) Verschluss des Vorhofsohres

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18 PROTECT AF/PREVAIL Meta-Analysis: WATCHMAN Comparable to Warfarin HR p-value Efficacy All stroke or SE Ischemic stroke or SE Hemorrhagic stroke Ischemic stroke or SE >7 days CV/unexplained death All-cause death SH AA MAY2015 Major bleed, all Major bleeding, non procedure-related Favors WATCHMAN! " Favors warfarin Hazard Ratio (95% CI) Holmes, DR et al. JACC In Press. CE Mark 2005.Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Information not intended for use or distribution in France.

19 Stroke Rate im Kontrollarm tiefer als bei anderen Studien Trial (Warfarin Arm) Ischemic Stroke Rate per 100 pt-yrs Mean CHADS 2 PREVAIL PROTECT AF RE-LY ROCKET AF ARISTOTLE SH AA MAY2015 ENGAGE Rate per Patient-years 1 WATCHMAN FDA Panel Sponsor Presentation. Oct Miller. AJC (2012) 3 Giugliano. NEJM (2013). CE Mark 2005.Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Information not intended for use or distribution in France.

20 Risikofaktoren bei Watchman-Studien 50% 40% Anticoagulation Eligible 1 CHA 2 DS 2 -VASc High Risk 1 Score 2 2 PROTECT AF 93% CAP 96% PREVAIL 100% CAP2 100% Patients (%) 30% 20% SH AA MAY % 0% CHA 2 DS 2 -VASc Score 1 AHA/ACC/HRS Guidelines (2014). 2 Holmes, DR et al. JACC In Press. CE Mark 2005.Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Information not intended for use or distribution in France.

21 PROTECT AF/PREVAIL Meta-Analysis: Weniger Blutungen nach 6 Monaten (stop OAK / Plavix) Free of Major Bleeding Event (%) WATCHMAN Arm Warfarin +Aspirin Warfarin +Aspirin Plavix +Aspirin HR = 0.29 p<0.001 Aspirin WATCHMAN Warfarin 71% Relative Reduction In Major Bleeding after cessation of warfarin and Plavix Time (days) Definition of bleeding: Serious bleeding event that required intervention or hospitalization according to adjudication committee Price, MP et al. TCT 2014 (Abstract) Price, MJ, et al. TCT 2014 (abstract) Time (months)

22 Watchman 5 Jahres-Daten: besser als OAK! Events in PROTECT AF trial at 2,717 patient years 39% lower 32% lower 54% lower P S = 95% P NI =>99% P S =99% P NI = Posterior Probability for Non-inferiority. P s = Posterior Probability for Superiority WATCHMAN FDA Panel Sponsor Presentation. Oct 2014

23 WATCHMAN Comparable to Warfarin for Primary Efficacy Cardiovascular / Unexplained Death (includes CV deaths preceded by stroke) Non-fatal Hemorrhagic Stroke WATCHMAN N=1000 Non-fatal Ischemic Stroke / Systemic Embolism Event-free Warfarin N= SH AA MAY N=1000; Each circle represents a single patient (N=1) with WATCHMAN or warfarin followed through five years Holmes, DR et al. JACC In Press. CE Mark 2005.Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Information not intended for use or distribution in France.

24 The WATCHMAN should only be used in patients who: have atrial fibrillation not related to heart valve disease. are at increased risk for a stroke. are recommended and suitable for anticoagulation. have an appropriate reason to seek a non-drug alternative to anticoagulation.

25 ACP occluder (Amplatzer, St. Jude Medical)

26 Amplatzer Cardiac Plug: Safety SAFETY Park, Initial European Experience 1 (2011) Walsh, European Prospective Obs. Study 2 (2012) Kefer, Belgium Registry 3 (2013) Urena, Canada Registry 4 (2013) Lopez-Minguez, Iberian Registry 5 (2014) Santoro, 4 yers Follow-up 6 (2014) Tzikas, Multicenter Experience 7 (2015) Procedural Success N=143 N=203 N=90 N=52 N=167 N=134 N= (96.4%) 197 (96.6%) 89 (98.9%) 51 (98.1%) 158 (94.6%) 128 (95.5%) 1019 (97.3%) Stroke TIA MI / coronary air / embolism Device embolization Major cardiac tamponade / perforation / effusion Major bleeding Other Major periprocedural complication 10 (7.3%) 6 (2.9%) 3 (3.6%) 2 (3.8%) 9 (5.4%) 4 (3.0%) 52 (5.0%) 1. Park, J-W. et al (2011) Left atrial appendage closure with ACP in AF initial European experience. Catheterization and Cardiovascular Interventions. 77: Walsh, K. (2012) left atrial appendage closure with the ACP: Results of the European Prospective Observational Study. Presented at EuroPCR. Paris May 17th.France 3. Kefer, J. et al. (2013) Transcatheter percutaneous left atrial appendage closure for stroke prevention in atrial fibrillation: the Belgian Registry. Paper presented at : europcr: May 24th Paris France. 4. Urena M, et al. (2013) Percutaneous Left Atrial Appendage Closure with the ACP in Patients with Non-Valvular AF and Contraindications for Anticoagulation Therapy. J Am Coll Cardiol. Jul 9;62(2): Lopez-Minguez et al. (2015) Two-year clinical outcom from the Iberian registry patients after appendage closure. Heart 101: Santoro G. et al. (2014) Percutaneous left atrial appendage occlusion in patients with non-valvular fibrillation: implantation and up to four years follow-up of the Amplatzer. Eurointerv. October 2014;10 7. Tzikas et. Al (2015) Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicenter experience with the Amplatzer Cardiac Plug EuroIterv. 2015;10

27 Amplatzer Cardiac Plug: Efficacy EFFICACY Walsh, European Prospective Obs. Study 2 (2012) Kefer, Belgium Registry 3 (2013) Urena, Canada Registry 4 (2013) Lopez-Minguez, Iberian Registry 5 (2014) Santoro, 4 yers Follow-up 6 (2014) Tzikas, Multicenter Experience 7 (2015) N=203 N=90 N=52 N=167 N=134 N=1047 Duration (Months) Mean: 6 Mean: 12 Mean: Mean: 22 Mean: 13 CHADS 2 CHA 2 DS 2 -VASc Annual stroke/tia rate: Actual Predicted % % 2.14% 5.08% % 5.9% 2.4% 9.6% 2.5% 7.7% 2.3% 5.6% Risk reduction 65% 58% 68% 75% 86% 59% 2. Walsh, K. (2012) left atrial appendage closure with the ACP: Results of the European Prospective Observational Study. Presented at EuroPCR. Paris May 17th.France 3. Kefer, J. et al. (2013) Transcatheter percutaneous left atrial appendage closure for stroke prevention in atrial fibrillation: the Belgian Registry. Paper presented at : europcr: May 24th Paris France. 4. Urena M, et al. (2013) Percutaneous Left Atrial Appendage Closure with the ACP in Patients with Non-Valvular AF and Contraindications for Anticoagulation Therapy. J Am Coll Cardiol. Jul 9;62(2): Lopez-Minguez et al. (2015) Two-year clinical outcom from the Iberian registry patients after appendage closure. Heart 101: Santoro G. et al. (2014) Percutaneous left atrial appendage occlusion in patients with non-valvular fibrillation: implantation and up to four years follow-up of the Amplatzer. Eurointerv. October 2014;10 7. Tzikas et. Al (2015) Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicenter experience with the Amplatzer Cardiac Plug EuroIterv. 2015;10

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29 Expected and observed stroke rates in patients implanted with the ACP device Stroke risk reduction % v expected 0 Patients Patient Years Strokes/ TIAs NR

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31 Eigene Resultate

32 Indikation LAA occluder bei PCI

33 Zusammenfassung Stroke bei VoFLi hat 30% vaskuläre Ursachen OAK wird bei ca 30% abgesetzt Watchman ist gleichwertig wie OAK Amulet ist eine Alternative, va ohne OAK Die nächsten Guidelines werden eine erweiterte Indikation für LAA occluder haben