Actualidades en Cierre de

Orejuela/Update for Left Atrial

Appendage Occluder Technology:
News and Trends

Dr. Roberto Muratalla González

CMN 20 de Noviembre
ISSSTE
Conflictos de Interés
• Consulting y Proctoring para Boston Scientific en Dispositivo para
LAAO Watchman

• Consulting y Proctoring para Abbott en Dispositivo para LAAO

Amplatzer Amulet
Fibrilación Auricular no Valvular

Arch Cardiovasc Dis. 2015 Oct;108(10):530-9

European Heart Journal (2016) 37, 2893–2962 Arch Cardiovasc Dis. 2015 Oct;108(10):530-9
 ACCEPTED MANUSCRIPT
January CT, et al.
ACCEPTED MANUSCRIPT
2019 Focused Update on Atrial Fibrillation

January CT, et al.

2019
2019 Focused AHA/ACC/HRS
Update Focused Update of the 2014 AHA/ACC/HRS
on Atrial Fibrillation
Guideline for the Management of Patients With Atrial Fibrillation
was reported to reverse the effects of rivaroxaban and apixaban (S4.3-3, S4.3-4) and was approved
underA Report of the American
the FDA’s College of Cardiology/American
accelerated-approval pathway on Heart Association
the basis Task Force
of effects in on
healthy volunteers.

PT
Clinical Practice Guidelines and the Heart Rhythm Society
Continued approval may be contingent on postmarketing studies to demonstrate an improvement
in hemostasis inDeveloped
patients.in Collaboration With the Society of Thoracic Surgeons

RI
WRITING GROUP MEMBERS*
4.4. Nonpharmacological
Craig T. January, Prevention
Stroke MD, PhD, FACC, Chair

PT
L. Samuel Wann, MD, MACC, FAHA, Vice Chair

4.4.1. Percutaneous Approaches to Occlude the LAA
Hugh Calkins, MD, FACC, FAHA, FHRS*†
Lin Y. Chen, MD, MS, FACC, FAHA, FHRS†
Joaquin E. Cigarroa, MD, FACC‡
Recommendation for Percutaneous
SC
Michael E. Field, MD, FACC, FAHA, FHRS║
Karen L. Furie, MD, MPH, FAHA║
Paul A. Heidenreich, MD, FACC, FAHA¶
Approaches to Occlude the LAA

RI
Joseph C. Cleveland, Jr, MD, FACC*§ Katherine T. Murray, MD, FACC, FAHA, FHRS║

U
Referenced
Patrickstudies
T. Ellinor,that support the new recommendation
MD, PhD*† Julie B. Shea,are
MS, summarized
RNCS, FHRS*║ in Online Data Supplement
4. M. Tracy, MD, FAHA*║
Michael D. Ezekowitz, MBChB, DPhil, FACC, FAHA*║ Cynthia

AN
Clyde W. Yancy, MD, MACC, FAHA║
COR LOE Recommendation

SC
1. Percutaneous LAA TASK
ACC/AHA occlusion may be considered in patients with AF at increased
FORCE MEMBERS

M
risk of stroke
Glenn N.who have
Levine, MD,contraindications
FACC, FAHA, Chair to long-term anticoagulation (S4.4.1-
Patrick T. O’Gara, MD, MACC, FAHA, Chair-Elect
IIb B-NR 1–S4.4.1-5).
Jonathan L. Halperin, MD, FACC, FAHA, Immediate Past Chair#

U
Sana M. Al-Khatib,NEW : Clinical
MD, MHS, FACC, trial
FAHA data and FDAGidding,
Samuel approval of the Watchman device necessitated
MD, FAHA#
this
Joshua A. Beckman, recommendation.
MD, MS, FAHA Zachary D. Goldberger, MD, MS, FACC, FAHA
Kim K. Birtcher, PharmD, MS, AACC Mark A. Hlatky, MD, FACC, FAHA

AN
Biykem Bozkurt, MD, PhD, FACC, FAHA# John Ikonomidis, MD, PhD, FAHA#
Recommendation-Specific Supportive
Ralph G. Brindis, MD, MPH, MACC# Text (New)José A. Joglar, MD, FACC, FAHA
Joaquin E. Cigarroa, MD, FACC Laura Mauri, MD, MSc, FAHA#
1. Percutaneous LAAPhD,
Lesley H. Curtis, occlusion
FAHA# with the Watchman device
Mariann hasRN,
R. Piano, beenPhD,compared
FAAN, FAHA with warfarin in
patients with
Anita AF MD,
Deswal, (in the
MPH,absence of moderate Susan
FACC, FAHA Mto severe mitral
J. Pressler, PhD,stenosis
RN, FAHA#or a mechanical heart valve)
Lee A. Fleisher,
at increased risk ofMD, FACC, in
stroke FAHA Barbara
2 RCTs: the PROTECT AFRiegel, PhD, RN, FAHA#
(WATCHMAN Left Atrial Appendage System for
Federico Gentile, MD, FACC Duminda N. Wijeysundera, MD, PhD
Embolic Protection in Patients With Atrial Fibrillation) (S4.4.1-1) and the PREVAIL (Evaluation of the
PROFECT AF 4 años
PREVAIL
Arch Cardiovasc Dis. 2015 Oct;108(10):530-9
Ewolution Registry
Ewolution Registry a 1 año
Ewolution Registry a 1 año

Heart Rhythm, Vol 14, No 9, September 2017

Ewolution Registry a 1 año

Heart Rhythm, Vol 14, No 9, September 2017

Ewolution Registry a 1 año

Heart Rhythm, Vol 14, No 9, September 2017

Ewolution Registry a 1 año

Heart Rhythm, Vol 14, No 9, September 2017

J A C C V O L . 6 9 , NO. 3 , 2 0 1 7
J A C C V O L . 6 9 , NO. 3 , 2 0 1 7
 Éxito: 99%

EuroIntervention 2017;13:867-876 published online ahead of print June 2017

 JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY VOL. 71, NO. 14, 2018 Men 299 (61.4) 169 (62.1) 112 (61.9) 0.99 sion mo
ª 2018 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION

PUBLISHED BY ELSEVIER Medical history p value

Hypertension 328 (84.1) 217 (84.1) 102 (85.7) 0.69 univariat
JACC VOL. 71, NO. 14, 2018 Fauchier et al.
Diabetes mellitus 119 (30.6) 76 (29.6) 39 (32.8) 0.53Occlusion in Atrial Fibrillation
APRIL 10, 2018:1528–36 Left Atrial Appendage
analysis.
Device-Related Thrombosis After Ischemic stroke 179 (41.1) 102 (38.6) 69 (44.2) 0.26
statistica
Vascular disease 141 (43.4) 85 (44.0) 50 (42.0) 0.73
Percutaneous Left Atrial Appendage Permanent AF 244 (51.2) 132 (49.6) 102 (52.0) 0.61 RESULT
Occlusion for Atrial Fibrillation LV ejection fraction, %
F I G U R E 1 Flowchart of the Study Group 55.9 ! 10.0 56.4 ! 9.3 55.4 ! 10.4 0.32
LAA maximum diameter, 21.9 ! 4.4 21.4 ! 4.1 22.6 ! 4.9 0.01
Laurent Fauchier, MD,a Alexandre Cinaud, MD,a François Brigadeau, MD,b Antoine Lepillier, MD,c mm (n ¼ 353) 487 patients with AF and percutaneous LAA closure STUDY G
seen between February 2012 and January 2017
Bertrand
1534 Pierre,
Fauchier et al.
a d e
MD, Selim Abbey, MD, Marjaneh Fatemi, MD, Frederic Franceschi, MD, Paul
J A C C VGuedeney,
O L . 7 1 , N O . 1 4 , MD,
2018
f g
CHA2DS2-VASc score 4.5 ! 1.4 4.4 ! 1.5 4.7 ! 1.2 0.008 with AF
Peggy Left Atrial Appendage Occlusion in Atrial Fibrillationc
MD,h Olivier Paziaud, MD, Sandrine Venier, MD,h Jean Claude Deharo, MD,f Daniel Gras, MD,d
APRIL 10, 2018:1528–36
Jacon,
HAS-BLED score 3.7 ! 1.0 3.7 ! 1.018 patients
3.8excluded:
! 1.0 0.08 to Janua
Didier Klug, MD,b Jacques Mansourati, MD,e Gilles Montalescot, MD,g Olivier Piot, MD,c Pascal Defaye, MDh . 2 Coherex Wavecrest device
Indication . 16 not implanted: istics of t
ABSTRACT
Previous bleeding 426 (90.1) 237 (89.4) .. 61 due
due to anatomical reason
174 (91.1)
to transseptal
0.55 of succes
C E NT R A L IL LU ST R A T I O N Kaplan-Meier Cumulative Event-Free Curves of Ischemic Strokes and Transient Ischemic catheterization complication
Contraindication to OAC 345 (72.8) 199 (74.8) 136 (71.2) 0.40
Attacks With and Without Thrombus on the Device . 1 LAA thrombus during procedure 272 pati
BACKGROUND Transcatheter left atrial appendage (LAA) occlusion is an alternative strategy for stroke prevention in Recurrent ischemic stroke 25 (5.3) 18 (6.8) . 8 due5to(2.6) another reason 0.05

patients with atrial fibrillationIschemic

nitinol ca
(AF). Stroke / Transient Ischemic Attack LAA closure device
Nitinol cage 469 patients included:
272 (55.9) — — —
device (
OBJECTIVES This study sought to determine the incidence, predictors, and prognosis of thrombus formation on - 272 Watchman devices (58%)
1.0 with AF who were treated with LAA closure.
devices in patients No thrombus Nitinol plug - 197 (40.5)
197 Amplatzer device (42%)
— — — Amplatz
339 patients (72%) with LAA imaging
WaveCrest 2 (0.4) — — — version o
METHODS The study retrospectively analyzed data from patients treated with 2 LAA closure devices seen in 8 centers in
0.8
France from February 2012 to January 2017.
Implantation failure 16 (3.3) — — — patients
Thrombus
Antithrombotic therapy at discharge Coherex
RESULTS A total of 469 consecutive patients with AF underwent LAA closure (272 Watchman devices [Atritech, Boston
0.6 No OAC, nonoAPT Single APT 37 (7.7)Dual APT 9 (3.3) OAC, no26
APT(13.2) <0.0001
No OAC, APT OAC plus APT (0.4%). O
Event Free

Scientific, Natick, Massachusetts] and 197 Amplatzer devices [St. Jude Medical, Minneapolis, Minnesota]). Mean follow-
Singlen =APT
35 (7.5%) n = 170 (36.2%) n = 109 (23.2%)
171 (35.8) 82 (30.1) n = 135 (28.8%)
88 (44.7) n = 20 (4.3%)
0.002
up was 13 ! 13 months, during which 339 (72.3%) patients underwent LAA imaging at least once. There were 98 major group co
0.4
adverse events (26 thrombi on devices, 19 ischemic strokes, 2 transient ischemic attacks, 18 major hemorrhages, 33 Dual APT 110 (23.0) 63 (23.2) 46 (23.4) 0.96
nitinol c
43.7 %
The study cohort from RELEXAO (REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion: NCT03279406) between February
deaths) recorded in 89 patients. The incidence of device-related thrombus in patients with LAA imaging was 7.2% per OAC, no APT 138 (28.9) 101 (37.1) 34 (17.3) <0.0001
1, 2007 and January 31, 2017 is shown. The proportions of the different devices for left atrial appendage (LAA) closure and patients with left
Thrombus
year. Older age (hazard vs. 1.07
ratio [HR]: no thrombus:
per 1-year increase; 95% confidence interval [CI]: 1.01 to 1.14; p ¼ 0.02) and
0.2 OAC plus
atrial appendage APT are shown, as well as the different
imaging 22 (4.6)
antithrombotic17 (6.3)at hospital discharge.
regimens 3 (1.5) AF ¼ atrial fibrillation;
0.009 STUDY T
history of stroke (HR:Log-rank
3.68; 95%testCI:p 1.17
< 0.0001
to 11.62; p ¼ 0.03) were predictors of thrombus formation on the devices, APT ¼ antiplatelet therapy; OAC ¼ oral anticoagulation.
HR 4.67, 95% CI 1.21-18.07, p = 0.03 LAA imaging during follow-up* 340 (72.1) 238 (87.5) 101 (51.3) <0.0001 discharg
whereas dual antiplatelet therapy (HR: 0.10; 95% CI: 0.01 to 0.76; p ¼ 0.03) and oral anticoagulation at discharge (HR:
Adjusted HR 4.39, 95% CI 1.05-18.43, p = 0.04
0.26; 95% CI:0.0
0.09 to 0.77; p ¼ 0.02) were protective factors. Thrombus on the device (HR: 4.39; 95% CI: 1.05 to 18.43;
treated w
p ¼ 0.04) and vascular disease (HR: 5.03; 95% CI: 1.39 to 18.23; p ¼ 0.01) were independent predictors of ischemic Values are mean ! SD or n (%). Percentages calculated from available data. *In patients with implanted device.
strokes and transient0ischemic attacks during
6 follow-up. 12 18 24 implantation. Mean time to first LAA imaging was 2.8 device, whereas DAPT and OAC at discharge were non–vita
N at risk
Months ! 2.5 months, and mean time to thrombus detection 28 %
AF ¼ atrial fibrillation; APT ¼ antiplatelet therapy; CHA2DS2-VASc ¼ congestive heart failure, hypertension,
associated with a lower risk of thrombus on device
age $75 years, diabetes mellitus, prior stoke or transient ischemic attack or thromboembolism, vascular disease, tients tre
Thrombus formation100
on the device is not on the device was 3.1 ! 2.6 months. The rate of (Table 4).
No thrombus
CONCLUSIONS 300 72 uncommon in patients
62 with AF who
39are treated by LAA age 65 to 74 years, and female sex; HAS-BLED ¼ hypertension, abnormal renal and liver function, stroke,
Thrombus
closure. Such events 25 are strongly associated 12 with a higher risk
6 of ischemic stroke
2 during follow-up.
0 (REgistry on Real-Life
thrombus
bleeding, labile international normalized ratio, elderly (age Information
on the device was 8.3% in patients with on subsequent
<65 years), drug antithrombotic
or alcohol use; therapy
LAA ¼ left atrial with the
EXperience With Left Atrial Appendage Occlusion [RELEXAO]; NCT03279406) (J Am Coll Cardiol 2018;71:1528–36) LAA imaging using TEE and 5.3% with LAA imaging was
appendage; LV ¼ left ventricular; OAC ¼ oral anticoagulation. available for 77% of patients with thrombus on
Fauchier, L. et al. J Am Coll Cardiol. 2018;71(14):1528–36.
using a CT scan (p ¼ 0.52). the device: 30% had a change in therapy, mainly
CHA 2DS2
© 2018 by the American College of Cardiology Foundation.
The curves are representative of being event-free for ischemic strokes and transient ischemic attacks, with and without thrombus on the device, after left atrial
The overall incidence of thrombus on the device consisting of OAC initiation in those not previously sion, age
 4 Asmarats and Rodés-Cabau Percutaneous Left Atrial Appendage Closure

LAAO Today Downloaded from http://ahajournals.org by on Oc

Figure 1. Percutaneous left atrial appendage closure devices. A and B, The WATCHMAN (A) and WATCHMAN FLX (B) devices. Courtesy
of Boston Scientific, ©2017 Boston Scientific Corporation or its affiliates, all rights reserved. C and D, Example of WATCHMAN implan-
tation. Procedural angiographic (C) and echocardiographic (D) views of an implanted WATCHMAN device. E and F, The AMPLATZER
Circ Cardiovasc Interv. 2017;10:e005359. DOI: 10.1161/CIRCINTERVENTIONS.117.005359
Cardiac Plug (E) and Amulet (F) devices. Reprinted from Swaans et al13 with permission. Copyright ©2016, Dove Medical Press. G and
H, Example of AMPLATZER Cardiac Plug (ACP) implantation. Fluoroscopic (G) and transesophageal echocardiography (H) images of a
 Table 2. Technical Success and Procedure-Related Complications Associated With Percutaneous Left Atrial Appendage Closure
Serious Device Major Procedure- Total Major
Technical Pericardial Embolization Ischemic Bleeding† Related Death Safety Events
n Success (%) Effusion* (%) (%) Stroke (%) (%) (%) (%)
WATCHMAN
PROTECT-AF8 463 90.9 4.8 0.6 1.1 0.6 0 8.7
CAP 11,26
566 94.4 1.4 0.2 0 … 0 4.1
ASAP 27
150 94.7 1.3 1.3 0.7 1.3 0 8.7
PREVAIL11 269 95.1 1.9 0.7 0.4 0.4 0 4.2
CAP2 28
579 94.8 1.9 0 0.4 … 0 3.8
Frankfurt Experience 29
102 96.1 2.9 0 0 … 0 8.8
EWOLUTION 30
1021 98.5 0.3 0.2 0 0.7 0.1 2.8
Canadian Experience31 106 97.2 0.9 0.9 0 1.9 0.9 1.9
US Post-FDA Approval 28
3822 95.6 1.0 0.2 0.1 … 0.1 1.4
ACP/Amulet
Initial European Experience32 143 96.4 3.5 1.4 2.1 … 0 7.0
ACP EU Post-Market Registry33 204 96.6 1.5 1.5 0 … 0 2.9

LAAO Today
Bern Experience 34
120 97.5 1.6 1.6 0.8 … 0.8 6.7
Israel Experience 35
100 100 1.0 0 0 … 0 1.0
Iberian Registry36 167 94.6 1.2 0.6 1.2 … 0 5.4
ACP International Experience37 1047 97.3 1.2 0.8 0.9 1.2 0.8 5.0
Swiss Experience 38
500 97.8 3.2 2.0 1.0 0.2 0.4 5.8
Nordic Experience 39
176 97.7 0.6 0.6 0 1.7 0 4.0
Downloaded from http://ahajournals.org by on October 10, 2018

Danish Experience40 110 100 0 0.9 0.9 2.8 0.9 4.6

Amulet Observational Study41 1088 99.0 1.2 0.1 0.2 2.4‡ 0.2 3.2
Italian Registry 42
613 95.4 2.0 0.7 0.2 3.3‡ 0 6.2
LARIAT
US Initial Experience43 154 93.5 10.4 … 0 9.1‡ 0.6 9.7
US LARIAT Registry 44
712 95.5 3.4 … 0 2.7 0.1 5.3
Mixed devices
Leipzig Experience45 179 98.9 1.1 1.7 0 … 0 3.3
Korean Registry 46
96 96.8 2.1 1.0 0 1.0 1.0 4.1
Milan Experience 47
165 99.4 0.6 0 0 1.8 0 4.8
UK Registry 48
371 92.5 0.5 0.8 0.5 1.3 0.3 3.5
ACP indicates Amplatzer Cardiac Plug; ASAP, ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology; CAP, Continued Access to
PROTECT-AF; CAP2, Continued Access to PREVAIL; EU, European Union; EWOLUTION, Registry on Watchman Outcomes in Real-Life Utilization; FDA, Food and Drug
Circ Cardiovasc Interv. 2017;10:e005359. DOI: 10.1161/CIRCINTERVENTIONS.117.005359
Administration; PREVAIL, Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin
Therapy; and PROTECT-AF, WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation.
 Table 3. Long-Term Clinical Outcomes After Percutaneous Left Atrial Appendage Closure
Ineligible Device Significant
CHADS2 for OAC* Follow-Up Duration** Ischemic Stroke Thrombosis Peridevice Major Bleeding All-Cause
n (mean±SD) (%) (Months) (%) (%) Leak† (%) (%) Mortality (%)
WATCHMAN
PROTECT-AF8–10 3.2; 2.2 per 4.5; 3.0 per
18±10; 1065 PY 5.753 11.854‡ 3.5
100 PY 100 PY
4.1; 1.9 per 7.3; 3.2 per
463 2.2±1.2 0 27.6±13.2; 1588 PY … … …
100 PY 100 PY
5.2; 1.4 per 12.3; 3.2 per
45.6±20.4 2621 PY … … 4.8
100 PY 100 PY
ASAP27,55 2.0; 1.7 per 6.0; 5.0 per
14.4±8.6; 176.9 PY 4.0 … …
100 PY 100 PY
150 2.8±1.2 100
… … … … …
55.4 [1.2–75.6]; 651 PY
1.8 per 100 PY 1.8 per 100 PY 4.6 per 100 PY
PREVAIL11 269 2.6±1.0 0 11.8±5.8 1.9 … … … 2.6§
Frankfurt Experience29 2.1; 0.7 per 6.3; 2.1 per 10.4; 3.5 per
102 2.7±1.3 25 36±19.2; 276.6 PY 2.1 0
100 PY 100 PY 100 PY
EWOLUTION 56
1021 2.8±1.3 73 12 1.1 3.7 1.0 2.6 9.8
Canadian Experience31 106 2.8±1.2 99 6.9±6.0 0 1.0 0 4.7 3.8
ACP/Amulet

LAAO Today
ACP EU Post-Market 1.0; 2.0 per
204 2.6±1.3 89 6; 101.2 PY 2.4 1.1 … …
Registry33 100 PY
Bern Experience ║ 34
152 3.4±1.7¶ 70 32 [0.4–120] 1.3 16 … 2.6 9.9
Iberian Registry36 4.4; 2.4 per 5.7; 3.1 per 10.8; 5.8 per
167 3 (2–4) 74 22±8.3; 290 PY 8.2 0
100 PY 100 PY 100 PY
ACP International 1,5; 2.1 per
1047 2.8±1.3 73 13 [6–25]; 1349 PY 0.9 4.4 1.9 4.2
Downloaded from http://ahajournals.org by on October 10, 2018 Experience37 100 PY
Nordic Experience 39
1.3; 1.7 per 2.6; 3.5 per 1.3; 1.7 per
151 3.9±1.6¶ 100 6.0 [2.9–12.2]; 115 PY … …
100 PY 100 PY 100 PY
Danish Experience40 5.6; 2.3 per 9.3; 3.8 per
107 4.4±1.6¶ 91 27.6 [19.2–38.4]; 265 PY 1.9 … 18.7
100 PY 100 PY
Amulet Observational
1088 4.2±1.6¶ 83 2.4±0.8 0.1 1.5 1.8 4.0 2.1
Study41
Italian Registry42 2.6; 1.6 per 3.7; 2.2 per 7.4; 4.5 per
613 4.2±1.5¶ 85 19.9±17.1; 896 PY 1.8 0.5
100 PY 100 PY 100 PY
LARIAT
US Initial Experience43 154 3 (2–4) 62 3.7 [1.6–8.9] 1.5 4.8 6.3 … 2.6
US LARIAT Registry44 712 2.7±1.3 79 3 … 2.5 0.2 … …
Mixed
Leipzig Experience45 179 2.8±1.1 100 6 0 4.2 0.6# 0.7 0.7
Korean Registry46 96 2.5±1.2 100 21.9 4.2 3.1 0# 1.0 5.2
Milan Experience47 165 3.9±1.7¶ 77 14.7 [6–26] 0 0.9 1.8# 1.3 3.3
UK Registry48 1.2; 0.6 per 0.9; 0.4 per 3.8; 1.8 per
371 2.6±1.2 95 24.7±16.1; 706 PY … …
100 PY 100 PY 100 PY
ACP indicates Amplatzer Cardiac Plug; ASAP, ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology; CHADS2, congestive heart failure history,
hypertension history, age ≥75 years, diabetes mellitus history, stroke or transient ischemic attack symptoms previously; EU, European Union; EWOLUTION, Registry on Watchman
Circ Cardiovasc Interv. 2017;10:e005359. DOI: 10.1161/CIRCINTERVENTIONS.117.005359
Outcomes in Real-Life Utilization; FDA, Food and Drug Administration; OAC, oral anticoagulation; PREVAIL, Prospective Randomized Evaluation of the WATCHMAN LAA Closure
Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy; PROTECT-AF, WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients with Atrial
 Table 4. Main Ongoing and Future Studies on Percutaneous LAAC
ASAP-TOO (NCT02928497)
PRAGUE-17 (NCT02426944)
Edoxaban in patients with
nonvalvular AF and LAAC
(NCT0308807)
Amulet IDE (NCT02879448)
TAVI-LAAC (NCT02678871)
Device Study Design Patients Intervention Primary End Point
The primary safety end point is the 7-day combined
LAAC vs single or no rate of death, ischemic stroke, systemic embolism,
antiplatelet therapy in and complications requiring major cardiovascular or
WATCHMAN Randomized 888 endovascular intervention.
patients ineligible for
OAC The primary efficacy end point is the comparison of time to
first event of ischemic stroke and systemic embolism.
The primary end point is the combination of stroke, other
Amulet or Randomized, systemic cardiovascular event, clinically significant bleeding,
400 LAAC vs DOAC
WATCHMAN open label cardiovascular death or procedure, or device-related
complications.
The primary outcome is a composite of death, stroke,
Prospective
WATCHMAN 75 Edoxaban after LAAC systemic embolism, or GUSTO moderate/severe bleeding
registry
will be collected at 6 wk post-WATCHMAN LAAC.
Safety: composite of procedure-related complications, or all-
cause death, or major bleeding through 12 mo.
Efficacy: composite of ischemic stroke or systemic
Amulet or embolism through 18 mo.
Randomized 1600 Amulet vs WATCHMAN
WATCHMAN
Mechanism of action: device closure (defined as residual jet
around the device ≤ 5 mm) at the 45-day visit documented
by transesophageal echocardiogram defined by Doppler
flow.
Early safety: composite end point of TAVR-related (VARC 2

LAAO Future
criteria) and percutaneous LAAC-related events at 30 days:
all cause-mortality, all stroke, life threatening bleeding,
Lotus valve Prospective Simultaneous acute kidney injury, coronary artery obstruction requiring
50
WATCHMAN registry TAVR+LAAC intervention, major vascular complications, valve-related
dysfunction requiring repeat procedure, pericardial effusion

Downloaded from http://ahajournals.org by on October 10, 2018

requiring pericardial drainage, and LAA device embolization
requiring surgical intervention.
WATCH-TAVR TAVR+LAAC (150 First occurrence of all-cause mortality, stroke (ischemic
WATCHMAN
(NCT03173534) Randomized 400 staged, 50 combined) or hemorrhagic), or bleeding (life-threatening and major)
TAVR
vs TAVR alone (n=200) events through 1 y.
WATCHMAN FLX LAAC 30-day procedural complications.
WATCHMAN Prospective
device Post-Approval study 300 LAAC
FLX registry 2-year incidence of stroke and death.
(NCT02654470)
WaveCrest Post-Market
Prospective All-cause deaths and device- and procedure-related events
Clinical Follow-up study WaveCrest 65 LAAC
registry at 45 days.
(NCT03204695)
aMAZE (NCT02513797) LARIAT+PVI vs PVI Freedom from episodes of atrial fibrillation > 30 s at 12 mo
LARIAT Randomized 600
alone post-pulmonary vein isolation.
LASSO-AF (NCT02593178) Safety: 30-day device or procedure-related major adverse
events: all-cause death, stroke, systemic embolism, major
Aegis Sierra
Prospective bleeding, coronary arteries injury requiring intervention,
Ligation 30 LAAC
registry myocardial infarction, intervention for device or procedure-
System
related complications, complications related to epicardial
access.
STROKECLOSE LAAC vs medical
Composite end point of stroke (ischemic or hemorrhagic),
(NCT02830152) treatment in patients
Amulet Randomized 750 systemic embolism, life-threatening or major bleeding, and
with prior intracerebral
all-cause mortality.
hemorrhage
AF indicates atrial fibrillation; aMAZE, Left Atrial Appendage Ligation With the LARIAT Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation
Circ Cardiovasc Interv. 2017;10:e005359.
for Persistent or Longstanding Persistent Atrial DOI: 10.1161/CIRCINTERVENTIONS.117.005359
Fibrillation; Amulet IDE, Amplatzer Amulet LAA Occluder Trial; ASAP-TOO, Assessment of the Watchman Device
in Patients Unsuitable for Oral Anticoagulation; DOAC, direct oral anticoagulant; GUSTO, Global Use of Strategies to Open Occluded Arteries; LAAC, left atrial
LAAO Future
12 Asmarats and Rodés-Cabau Percutaneous Left Atrial Appendage Closure

Table 4. Main Ongoing and Future Studies on Percutaneous LAAC

Device Study Design Patients Intervention Primary End Point
ASAP-TOO (NCT02928497) The primary safety end point is the 7-day combined
LAAC vs single or no rate of death, ischemic stroke, systemic embolism,
antiplatelet therapy in and complications requiring major cardiovascular or
WATCHMAN Randomized 888 endovascular intervention.
patients ineligible for
OAC The primary efficacy end point is the comparison of time to
first event of ischemic stroke and systemic embolism.
PRAGUE-17 (NCT02426944) The primary end point is the combination of stroke, other
Amulet or Randomized, systemic cardiovascular event, clinically significant bleeding,
400 LAAC vs DOAC
WATCHMAN open label cardiovascular death or procedure, or device-related
complications.
Edoxaban in patients with The primary outcome is a composite of death, stroke,
Prospective
nonvalvular AF and LAAC WATCHMAN 75 Edoxaban after LAAC systemic embolism, or GUSTO moderate/severe bleeding
registry
(NCT0308807) will be collected at 6 wk post-WATCHMAN LAAC.
Amulet IDE (NCT02879448) Safety: composite of procedure-related complications, or all-
cause death, or major bleeding through 12 mo.
Efficacy: composite of ischemic stroke or systemic
Amulet or embolism through 18 mo.
Randomized 1600 Amulet vs WATCHMAN
WATCHMAN
Mechanism of action: device closure (defined as residual jet
around the device ≤ 5 mm) at the 45-day visit documented
Circ Cardiovasc Interv. 2017;10:e005359. DOI: 10.1161/CIRCINTERVENTIONS.117.005359
Table 4. Main Ongoing and Future Studies on Percutaneous LAAC
Device Study Design Patients Intervention Primary End Point

LAAO Future
ASAP-TOO (NCT02928497)
LAAC vs single or no
antiplatelet therapy in
The primary safety end point is the 7-day combined
rate of death, ischemic stroke, systemic embolism,
and complications requiring major cardiovascular or
WATCHMAN Randomized 888 endovascular intervention.
patients ineligible for
OAC The primary efficacy end point is the comparison of time to
first event of ischemic stroke and systemic embolism.
PRAGUE-17 (NCT02426944) The primary end point is the combination of stroke, other
Amulet or Randomized, systemic cardiovascular event, clinically significant bleeding,
400 LAAC vs DOAC
WATCHMAN open label cardiovascular death or procedure, or device-related
complications.
Edoxaban in patients with The primary outcome is a composite of death, stroke,
Prospective
nonvalvular AF and LAAC WATCHMAN 75 Edoxaban after LAAC systemic embolism, or GUSTO moderate/severe bleeding
registry
(NCT0308807) will be collected at 6 wk post-WATCHMAN LAAC.
Amulet IDE (NCT02879448) Safety: composite of procedure-related complications, or all-
cause death, or major bleeding through 12 mo.
Efficacy: composite of ischemic stroke or systemic
Amulet or embolism through 18 mo.
Randomized 1600 Amulet vs WATCHMAN
WATCHMAN
Mechanism of action: device closure (defined as residual jet
around the device ≤ 5 mm) at the 45-day visit documented
by transesophageal echocardiogram defined by Doppler
flow.
TAVI-LAAC (NCT02678871) Early safety: composite end point of TAVR-related (VARC 2
criteria) and percutaneous LAAC-related events at 30 days:
Circ Cardiovasc Interv. 2017;10:e005359. DOI: 10.1161/CIRCINTERVENTIONS.117.005359
 alone post-pulmonary vein isolation.
LASSO-AF (NCT02593178) Safety: 30-day device or procedure-related major adverse
events: all-cause death, stroke, systemic embolism, major

LAAO Future
Aegis Sierra
Prospective bleeding, coronary arteries injury requiring intervention,
Ligation 30 LAAC
registry myocardial infarction, intervention for device or procedure-
System
related complications, complications related to epicardial
access.
STROKECLOSE LAAC vs medical
Composite end point of stroke (ischemic or hemorrhagic),
(NCT02830152) treatment in patients
Amulet Randomized 750 systemic embolism, life-threatening or major bleeding, and
with prior intracerebral
all-cause mortality.
hemorrhage
AF indicates atrial fibrillation; aMAZE, Left Atrial Appendage Ligation With the LARIAT Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation
for Persistent or Longstanding Persistent Atrial Fibrillation; Amulet IDE, Amplatzer Amulet LAA Occluder Trial; ASAP-TOO, Assessment of the Watchman Device
in Patients Unsuitable for Oral Anticoagulation; DOAC, direct oral anticoagulant; GUSTO, Global Use of Strategies to Open Occluded Arteries; LAAC, left atrial
appendage closure; LASSO-AF, Feasibility Study of the Aegis Sierra Ligation System in Left Atrial Appendage Closure in Patients With Atrial Fibrillation; OAC,
oral anticoagulation; PRAGUE-17, Interventional Left Atrial Appendage Closure vs Novel Anticoagulation Agents in High-Risk Patients With Atrial Fibrillation;
PVI, pulmonary vein isolation; TAVI-LAAC, Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage; TAVR,
transcatheter aortic valve replacement; VARC, Valve Academic Research Consortium; and WATCH-TAVR, Watchman for Patients With Atrial Fibrillation Undergoing
Transcatheter Aortic Valve Replacement.

Circ Cardiovasc Interv. 2017;10:e005359. DOI: 10.1161/CIRCINTERVENTIONS.117.005359

 Amulet or Randomized, systemic cardiovascular event, clinically significant bleeding,
400 LAAC vs DOAC
WATCHMAN open label cardiovascular death or procedure, or device-related
complications.

LAAO Future
Edoxaban in patients with
nonvalvular AF and LAAC WATCHMAN
Prospective
registry
75 Edoxaban after LAAC
The primary outcome is a composite of death, stroke,
systemic embolism, or GUSTO moderate/severe bleeding
(NCT0308807) will be collected at 6 wk post-WATCHMAN LAAC.
Amulet IDE (NCT02879448) Safety: composite of procedure-related complications, or all-
cause death, or major bleeding through 12 mo.
Efficacy: composite of ischemic stroke or systemic
Amulet or embolism through 18 mo.
Randomized 1600 Amulet vs WATCHMAN
WATCHMAN
Mechanism of action: device closure (defined as residual jet
around the device ≤ 5 mm) at the 45-day visit documented
by transesophageal echocardiogram defined by Doppler
flow.
TAVI-LAAC (NCT02678871) Early safety: composite end point of TAVR-related (VARC 2
criteria) and percutaneous LAAC-related events at 30 days:
all cause-mortality, all stroke, life threatening bleeding,
Lotus valve Prospective Simultaneous acute kidney injury, coronary artery obstruction requiring
50
WATCHMAN registry TAVR+LAAC intervention, major vascular complications, valve-related
dysfunction requiring repeat procedure, pericardial effusion
Downloaded from http://ahaj

requiring pericardial drainage, and LAA device embolization

requiring surgical intervention.
WATCH-TAVR TAVR+LAAC (150 First occurrence of all-cause mortality, stroke (ischemic
WATCHMAN
(NCT03173534) Randomized 400 staged, 50 combined) or hemorrhagic), or bleeding (life-threatening and major)
TAVR
vs TAVR alone (n=200) events through 1 y.
WATCHMAN FLX LAAC 30-day procedural complications.
WATCHMAN Prospective
device Post-Approval study 300 LAAC DOI: 10.1161/CIRCINTERVENTIONS.117.005359
Circ Cardiovasc Interv. 2017;10:e005359.
FLX registry 2-year incidence of stroke and death.
Conclusiones: LAAO
1.- FANV es la arritmia permanente mas frecuente en el mundo.
2.- LAAO es una alternativa a la anticoagulación.
3.- Indicacion actual IIb-B.
4.- Procedimiento Electivo.
5.- Esquema de Tx posterior al implante es para evitar la TROMBOSIS DEL
DISPOSITIVO.
6.- Estudio de Imagen OBLIGADO en los 3 primeros meses.
7.- NUNCA egresar al paciente sin tratamiento antiplaquetario dual o
anticoagulante.
8.- Riesgo Residual.
Dr. Roberto Muratalla González
HeartTeam México
CMN 20 de Noviembre ISSSTE

muratalla_2@hotmail.com