Advantages and disadvantages of different Advantages and disadvantages of different left atrial appendage closure systems.left atrial appendage closure systems.

Chair and 1st Department of Cardiology, Chair and 1st Department of Cardiology,

Poznan University of Medical Sciences, PolandPoznan University of Medical Sciences, Poland

Marek Grygier MD, PhD

www.escardio.org/guidelines European Heart Journal (2010) 31, 2369-2429

Approach to thromboprophylaxis in AF

AF = atrial fibrillation; CHA2DS2-VASc = cardiac failure, hypertension, age ≥ 75 (doubled), diabetes, stroke (doubled)-vascular disease, age 65–74 and sex category (female); INR = international normalized ratio; OAC = oral anticoagulation, such as a vitamin K antagonist (VKA) adjusted to an intensity range of INR 2.0–3.0 (target 2.5).

1-year bleeding risk assocciated with antithrombotic treatment

0

2

4

6

8

10

12

14

0 1 2 3 4 5 6 7 8 9

Euro Heart Survey

HAS-BLED score

Number of patients 798 1286 744 187 46 8 2 0 0 0

Number of bleeding episodes

9 13 14 7 4 1 0 0 0 0

Charakterystyka kliniczna Punkty

Nadciśnienie tętnicze (ciśnienie skurczowe >160 mm Hg)

1

Zaburzenia funkcji nerek lub wątroby 1 + 1

Udar mózgu 1

Krwawienie 1

Labilne wartości INR 1

Osoby w podeszłym wieku, >65 roku życia 1

Leki lub alkohol 1 + 1

Wynik całkowity Zakres 0-9

Pisters R et al. Chest 2010;138:1093–1100.

Mechanism of stroke in patients with AF.

blood flow in the LAA is slowed and can become

turbulent in the case of AF

a clot can form in the LAA which can embolize and cause a

stroke

Published reports of patients with non-rheumatic AF found thrombus present

in 12.6% of patients

90% of the thrombus was found in the LAA

7 SH-159501-AA MAY 2013

The Wind Sock Type LAA is an anatomy in which one dominant lobe of sufficient length is the primary structure.

The Chicken Wing Type LAA is an anatomy whose main feature is a sharp bend in the dominant lobe of the LAA anatomy at some distance from the perceived LAA ostium.

The Broccoli Type LAA is an anatomy whose main feature is an LAA that has limited overall length with more complex internal characteristics.

Major left atrial appendage types

8 SH-159501-AA MAY 2013

3. Assessment of LAA Dimensions

Assessment of LAA Dimensions

Surgical closure of the LAA.

Surgical closure of the LAA.

Percutaneous closure of the LAA

Percutaneous closure of the LAA- history …

What did the PLAATO data say ?

mean CHADS SCORE 2.5±1.3 expected annual risk of stroke: 6.5% follow-up: 3.2% stroke stroke risk reduction: 51%

Percutaneous closure of the LAA- what about tooday …

WATCHMAN LAA Closure Technology

The WATCHMAN device reduces the risk of stroke by closing off the left atrial appendage, which is known to be the main source of blood clots in patients with atrial fibrillation

Johnson, Eur J Cardiothoracic Surg 2000:17

16 SH-159501-AA MAY 2013

Frame: Nitinol structure• Available sizes:

– 21, 24, 27, 30, 33 mm (diameter)

– 10 Fixation anchors around device perimeter engage LAA tissue

– Contour shape accommodates most LAA anatomy

Fabric Cap: (PET) Fabric Polyethyl terephthalate

• Prevents harmful emboli from exiting during the healing process

• 160 micron filter

Anchors

PET fabric

WATCHMAN® LAA Closure System ComponentsWATCHMAN® LAA Closure System ComponentsWATCHMAN Device

17 SH-159501-AA MAY 2013

Double Curve

Single Curve

Transseptal Access System

• Double, Single, Anterior Curves

• 14F O.D. (4.7 mm), 12F I.D.

• 75 cm working length

Preformed curve shapes guide position in LAA

WATCHMAN® LAA Closure System ComponentsWATCHMAN Access System

18 SH-159501-AA MAY 2013

Constrained Device

Distal Marker Band

Hemostasis Valve

Core Wire

Deployment Knob

12F O.D. (compatible with all 5 device sizes)

WATCHMAN® LAA Closure System ComponentsWATCHMAN Delivery System

19 SH-159501-AA MAY 2013

All criteria must be met prior to device release

Position – device is distal to or at the ostium of the LAA

Anchor – (stability) fixation barbs engaged / device is stable

Size – device is compressed at least 8-20% of original size

Seal - device spans ostium, all lobes of LAA are covered

• If necessary, device can be recaptured (partial or full)

Device Release Criteria (PASS)

20 SH-159501-AA MAY 2013

Device Release Criteria – OPTIMAL POSITION

Fixation anchors engage LAA wall

PROTECT AF1,6 CAP2 ASAP3,4 PREVAIL5

Trial Design

Prospective RCT with patients able to

take warfarin

Prospective registry with patients able to take

warfarin

Prospective registry with patients contraindicated for

warfarin

Prospective RCT with patients able to take

warfarin

Outcome

WATCHMAN was non-inferior to

warfarin in patients at high-risk of

thromboembolism

Significantly improved safety results from early

PROTECT AF experience

Ischemic stroke rate significantly reduced in

warfarin contra-indicated patients

WATCHMAN device was safely implanted

by new operators

Mean age /CHADS2 72/2.2 74/2.4 72.4/2.8 74/2.6

Total Enrolled Subjects 707 randomized1 93 pts rolled in2 460 150 461

Total Patients Implanted 5422 437 142 269

Implantation Success 89.5%2 95.0% 94.7% 95.1%

Primary Efficacy (all-stroke, CV/unexplained

death, and systemic embolism)

40% reduction vs. warfarin6

29% reduction vs. warfarin N/A

0.064Identical 18-month rates

for WATCHMAN and warfarin

All-Stroke 32% reduction vs. warfarin6

23% reduction vs. warfarin

77% reduction vs. expected rate per CHADS₂ score

Data not yet available

Safety(7 day procedure-related*)

8.7%5

4.1%5

53% reduction vs. PROTECT AF

Pericardial effusion with tamponade=1.3%

Major bleeding=2.7%

4.4%49% reduction vs.

PROTECT AF

*Composite of vascular complications includes cardiac perforation, pericardial effusion with tamponade, ischemic stroke, device embolization, and Includes observed PE not necessitating intervention, AV fistula, major bleeding requiring transfusion, pseudoaneurysm, hematoma and groin bleeding

1 Holmes DR et al. Lancet 2009;374:534–42; 2 Reddy VY et al. Circulation. 2013; 127:720-729; 3 Sievert H. TCT 2011; 4 Reddy, JACC 2013; 5 Homes DR PREVAIL Mar 2016 Reddy, et al. HRS LBCT 2013

WATCHMAN™ Clinical ProgramAt 4yrs WATCHMAN was superior to warfarin in primary efficacy, all-cause mortality, & cardiovascular death

SH

-AA

-15

990

1-M

AY

20

13

PROTECT AF

SH

-AA

-15

990

1-M

AY

20

13

Patient Study Timeline:

Device subject takes Device subject takes warfarinwarfarinPreimplant intervalPreimplant interval

Day 0Day 0

Control subject takes warfarinControl subject takes warfarin

Device subject gets implantDevice subject gets implant

Device subject has ceased Device subject has ceased warfarinwarfarin

Ongoing to 5 yearsOngoing to 5 years

RandomizeRandomize

Day 0Day 0Day 45Day 45postimplantpostimplantDay 2-14Day 2-14 Ongoing to 5 yearsOngoing to 5 years

Dev

ice

Dev

ice

Control

Control

3000838-60

PROTECT AF Trial Endpoints

• Primary Efficacy EndpointPrimary Efficacy Endpoint• All stroke: ischemic or hemorrhagic All stroke: ischemic or hemorrhagic

• deficit with symptoms persisting more than 24 hours or deficit with symptoms persisting more than 24 hours or • symptoms less than 24 hours confirmed by CT or MRIsymptoms less than 24 hours confirmed by CT or MRI

• Cardiovascular and unexplained death: includes sudden death, Cardiovascular and unexplained death: includes sudden death, MI, CVA, cardiac arrhythmia and heart failure MI, CVA, cardiac arrhythmia and heart failure

• Systemic embolizationSystemic embolization

• Primary Safety Endpoint Primary Safety Endpoint • Device embolization requiring retrievalDevice embolization requiring retrieval• Pericardial effusion requiring interventionPericardial effusion requiring intervention• Cranial bleeds and gastrointestinal bleedsCranial bleeds and gastrointestinal bleeds• Any bleed that requires ≥ 2uPRBCAny bleed that requires ≥ 2uPRBC

• NB: Primary effectiveness endpoint contains safety eventsNB: Primary effectiveness endpoint contains safety events

Inci

denc

e R

ate

(%)

Warfarin GroupN=244

WATCHMAN Group

N=463

PNI = >99.9% PNI = >99.9%PNI = 99.3% PNI = >99.9%

PNI = Posterior non inferiority ProbabilitiesUnexplained Death

38% lower 29% lower

PROTECT AF – Primary Efficacy Endpoint – 1065 pt yrs

38% Reduction

David R Holmes, Lancet Vol 374 August 15, 2009

CAP

SH

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-15

990

1-M

AY

20

13

WATCHMAN™ PROTECT-AF & Continued Access Protocol (CAP)

Reddy VY et al. Circulation. 2011;123:417-424

SH

-AA

-15

990

1-M

AY

20

13

WATCHMAN™ PROTECT-AF & Continued Access Protocol (CAP)

Reddy VY et al. Circulation. 2011;123:417-424

67

58

50

40455055606570

PROTECT AF Early PROTECT AFLate

CAP

Average Time (Minutes)

Procedure Time

8891

95

80

85

90

95

100

PROTECT AFEarly

PROTECT AFLate

CAP

Success %

Implant Success

83

9195

70

80

90

100

PROTECT AFEarly

PROTECT AFLate

CAP

Discontinuation %

45 Day Discontinuation Rate Among Implanted

With experience procedure time decreased by 30% Implant success improved to 95%

Warfarin cessation increased to 95%

With increased operator experience

The average procedure time reduced from 67 minutes to 50 minutes

Implant success improved from 88% to 95%

Discontinuation of Warfarin improved from 83% to 95% of patients

SH

-AA

-15

390

2-A

PR

201

3

WATCHMAN™ PROTECT-AF & Continued Access Protocol (CAP)

Reddy VY et al. Circulation. 2011;123:417-424

10

5,53,7

0

5

10

15

PROTECT AF Early PROTECT AF Late CAP

Incidence %

Procedure/Device Related Safety Adverse Event Within 7 Days

6,3

3,7

2,2

0

2

4

6

8

10

PROTECT AF Early PROTECT AF Late CAP

Incidence %

Serious Pericardial Effusion Within 7 Days

With increased operator experience

Procedure related adverse events and serious pericardial effusions were reduced significantly

Peri-procedural strokes were eliminated

1,10,7

00

1

2

3

4

5

PROTECT AF Early PROTECT AF Late CAP

Incidence %

Procedure Related Stroke

SH

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-15

390

2-A

PR

201

3

PREVAIL

SH

-AA

-15

390

2-A

PR

201

3

PREVAIL Vascular Complications7 Day Serious Procedure/Device Related

Holmes TCTMD 2013PROTECT-AF and CAP data: Reddy, VY et al. Circulation. 2011;123:417-424.

n=39 n=23 n=12

p = 0.005

No procedure-related deaths reported in any of the trials

1 Includes observed PE not necessitating intervention, AV fistula, major bleeding requiring transfusion, pseudoaneurysm, hematoma and groin bleeding

Composite of vascular complications includes cardiac perforation, pericardial effusion with tamponade, ischemic stroke, device embolization, and other vascular complications1

49% reduction

SH

-AA

-15

390

2-A

PR

201

3

PREVAIL Implant Success

PROTECT AF Implant Success

90.9%

CAP Implant Success

94.3%

PREVAIL Implant Success

95.0%

p = 0.01

p = 0.282

N= 26N= 26

N= 24N= 24

Implant success defined as deployment and release of the device into the left atrial appendageHolmes TCTMD 2013

PROTECT-AF and CAP data: Reddy, VY et al. Circulation. 2011;123:417-424.

SH

-AA

-15

390

2-A

PR

201

3

ASAP

SH

-AA

-15

390

2-A

PR

201

3

WATCHMAN™ Preliminary Results ASA Plavix Feasibility Study

WATCHMAN Implantation for contra-indicated AF warfarin patients is: Feasible Low, but manageable, rate of device

thrombus Decreases the rate of stroke by 77%

5.0%

64%

Reddy, et al. JACC. 2013; In Press.

SH

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13

Design components of Amplatzer Cardiac PlugDesign components of Amplatzer Cardiac Plug(St. Jude Medical)(St. Jude Medical)

ACPInitial European Registry1

ACPItalian registry2

Dual Center experience3

Initial single centre experience4

ACP Post-Market Observational study5

Initial Asia Pacific experience 6

Belgian Registry 7

Single centre experience 8

Total

N = 143 N = 100 N = 135 N = 34 N = 204 N = 20 N = 82 N = 86 804

Enrollment period

12/2008-12/2009

12/ 2008-2/2010

2010-2011 NR 8/2009 – 9/2011 NR 6/2009 – 4/2012

1/2009 – 9/2011

SuccessfulDevice implant

132(96.4%)

99(99%)

131(98.5%)

34(100%)

197(96.6%)

19(95%)

81(98.8%)

85(98.8%)

Serious Pericardial Effusion

5 1 0 1 3 0 1 1 12

Device Embolization

2 0 0 0 3 0 0 1 6

Stroke / TIA 3 0 0 0 0 0 0 2 5

MyocardialInfarction

0 0 0 0 0 0 2 0 2

Total Major complication

10 (7.3%)

1 (1%)

0 (0%)

1 (2.9%)

6 (2.9%)

0 3 (3.6%)

4 (4.7%)

25 (3.1%)

Total Minor complication

7(5.1%)

3(3%)

3(2.3%)

0(0%)

NR 2 (10%)

4(4.9%)

2(2.3%)

21(2.6%)

ACP Results Across Series

1. Park, J.-W. et al., Left atrial appendage closure with AMPLATZER Cardiac Plug in Atrial Fibrillation: Initial European experience. Cath and Cardiovasc Interv., 2011 77: 700–706.2. G. Santoro, Italian Experience with AMPLATZER Cardiac Plug , Presented at the Progress In Clinical Pacing Congress in December 2010 (Rome).3. Park, J.W, et al. Dual Center Experience with Different Strategies of Left Atrial Appendage Closure with AMPLATZER Cardiac Plug for Prevention of Stroke in Atrial Fibrillation. Presented at UHK Mayo Clinic Asia

cardiovascular summit. 2011 26-7 March (Hong Kong)4. Meerkin, D., Butnaru, A., Dratva, D. and Tzivoni, D. (2011) Initial experience with the Amplatzer Cardiac Plug for left atrial appendage occlusion. Journal of American College of Cardiology. 57(14):E1684. 5. Walsh, K. (2012) left atrial appendage closure with the AMPLATZER Cardiac Plug: Results of the European Prospective Observational Study. Presented at EuroPCR. Paris May 17 th.France6. Lam Y.Y,, Yip, G.W., Yu, C.M., Chan, W.W., Cheng, B.C., Yan, B.P., Clugston, R., Yong, G., Gattoma, T., and Paul, V. (2011) left Atrial Appendage closure with Amplatzer cardiac plug for stroke prevention in atrial

fibrillation: initial Asia-Pacific experience. Catheter Cardiovascular Interventions. May 3. doi:10.1002/ccd.23136 (Epub ahead of print) Catheter Cardiovasc Interv. 2012 Apr 1;79(5):794-8007. Kefer, J., Vermeersch,P., Budts, W., et al. (2012) Transcatheter percutaneous left atrial appendage closure for stroke prevention in atrial fibrillation: the Belgian Registry. Paper presented at : euroPCR: May 15-18 th. Paris

France. 8. Guérios, E.E., Schmid, M., Gloekler, S., Khattab, A.A., Wenaweser, P.M., Windecker, S., Meier, B. (2012) Left atrial appendage closure with the Amplatzer Cardiac Plug in patients with atrial fibrillation Arq Bras Cardiol.

2012 http://www.arquivosonline.com.br/english/2012/AOP/aop04012_ing.pdf (accessed 1st May 2012)

Key Differentiators During LAAC Implant Procedure

Key Differentiators During LAAC Implant Procedure

ACP2

s

s CX

• Design based on familiar ASD/PFO closure

1 WATCHMAN IFU 2 ACP IFU

This document is intended for internal educational use only and shall not be distributed outside of Boston Scientific. 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

SH-AA

-188301-SEP

2013

Device Placement

Ostium

Landing Zone LAA Neck Orifice

LAA Body

Key Differentiators

• 1 size access sheath for ease of use • Radiopaque markers on access sheath and

delivery catheter • Designed specifically for LAA • Pre-loaded • Accommodates very large LAA>28mm (33mm

device) • More positional forgiveness (angle b/ delivery

system and LAA) • Placement of only 1 part system

• Disk may form a seal of the LAA (multiple lobes)

• May be implanted in more shallow anatomies than WATCHMAN (but not <10mm)

devices

WATCHMAN™1

Key differentiators during LAAC implant procedure

Combined (surgical and percutaneous) closure of the LAA.

LARIAT device:LARIAT device:

Lariat device – contraindications:Lariat device – contraindications: Absolute contraindication: Absolute contraindication: prior open heart surgery prior open heart surgery

Relative contrindications: Relative contrindications: clinical history of severe pericarditis, epicardial VT clinical history of severe pericarditis, epicardial VT

ablation, uraemia, severe obesityablation, uraemia, severe obesity

Based on anatomy:Based on anatomy: LAA width >40mmLAA width >40mm superiorly oriented LAA with thesuperiorly oriented LAA with the LAA apex directed LAA apex directed

behind the pulmonary vascular trunkbehind the pulmonary vascular trunk bilobed LAA or multilobed LAA in which lobes are bilobed LAA or multilobed LAA in which lobes are

orientedoriented in different angles in different angles

LAA occluder

Kryteria kwalifikacji do przezskórnego zamknięcia Kryteria kwalifikacji do przezskórnego zamknięcia uszka lewego przedsionka w prewencji powikłań uszka lewego przedsionka w prewencji powikłań

zakrzepowo-zatorowych u pacjentów z migotaniem zakrzepowo-zatorowych u pacjentów z migotaniem przedsionków: przedsionków:

wysokie ryzyko epizodów zakrzepowo-zatorowych wysokie ryzyko epizodów zakrzepowo-zatorowych (CHA2DS2VASc≥3) oraz przeciwwskazania do przewlekłego (CHA2DS2VASc≥3) oraz przeciwwskazania do przewlekłego leczenia antagonistami witaminy K;leczenia antagonistami witaminy K;

pozytywna opinia zespołu ekspertów (HEART TEAM) w pozytywna opinia zespołu ekspertów (HEART TEAM) w składzie: kardiolog inwazyjny, elektrofizjolog, kardiolog oraz składzie: kardiolog inwazyjny, elektrofizjolog, kardiolog oraz kardiochirurg. kardiochirurg.