Transcript 1 - Livemedia

Βηματοδότηση χωρίς ηλεκτροκαθετήρες.
Τα πρώτα αποτελέσματα από τις κλινικές μελέτες.
Ευαγγελία Χριστοφοράτου,
* Επιστημονικά Υπεύθυνη Τμήματος Βηματοδότησης Βιοκλινικής Αθηνών
* Επιστημονικός Συνεργάτης Α΄ Πανεπιστημιακής Καρδιολογικής Κλινικής ΓΝΑ
Ιπποκράτειο
Σεμινάρια Ομάδων Εργασίας
Ιωάννινα, 13-2-2016
Pacemaker Technology: History and Challenges
•
Technology:
– Highly mature and reliable
– Still includes generator, connectors,
and leads
•
Lead fracture
Procedure:
– Requires creation of a surgical pocket
– Relies on epicardial or transvenous
leads
•
Device/Pocket related challenges
–
–
–
–
•
Lead dislodgement
Discomfort
Hematomas
Infection
Cosmetic concerns
Pocket infection
Leads
–
–
–
–
Mechanical failures
Dislodgement
Infections
Extractions
Images: Kabayadondo Maidei Gugu and de Meester Antoine (2011). Early Complications After Pacemaker
Implantations, Cardiac Pacemakers - Biological Aspects, Clinical Applications and Possible Complications, Prof.
Mart Min (Ed.), ISBN: 978-953-307-639-3, InTech, DOI: 10.5772/20091.
Hematoma
Pacemaker Technology: History and Challenges
First
implantable
pacemak
er
First
microprocessor
based
pacemaker
First
AutoCapture
pacemak
er
First fully
wireless
pacemak
er
First
leadless
pacemak
er
History of Leadless Pacing: Idea Proposed in 1970
J. ELECTROCARDIOLOGY, 3 (3-4)
325-331,
1970
Special Article
Totally
Self-Contained
lntraca.rdiac Pacemaker*
S. RASOR .. PH.D.t, .PA'UL KEZDI~ M,D•
SPICKLER, PH.D., NED
MISRA,
M".:D., iK. £. ROBINS, P •. E.., AND
CHARLES
LeBOEUF, P.E.
J. WILLIAM
S. N.
Sl[AT:
~~
tI
,,,.,...., .,.
~~~~
l
r; -~--l I.
J J
n
rt:
.r.
r.m ... rr
Tl ' L
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INSERTION
\A
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ATTACHMENT
I
Bl
IMPLANTEO
IC
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Spickler et al. J Electrocardiol 1970;3:325-331
History of Leadless Pacing: Miniature Pacemaker Tested in 1991
©
EUR..J.CIPIE.1991
byEBM
.. 1:27-80
lVlirrla.-tu.re Pacemaker
Introduced
Intravenoulsy
an.d Implanted
Endocardially.
Preliminary
Findings
£rom
art
Exp,erimen.tal
Study
_A
P.E.
V.ARDA5,C.
POLITOPOULOS,
E. l'vlANIOS,
F. PA.RTI--IENAKIS
.. and
.
C. TSA.GARAKIS
Vardas et al Eur J Card Pacing Electrophysiol. 1991;1:1-47
Leadless Pacemakers
WiCSTM / EBR
May 2011
NanostimTM / SJM
December 2012
MicraTM / Medtronic
December 2013
What is a leadless pacemaker?
Total volume
Communication
Miera TPS
10.6
0.8 cc
cc·
Mass
Rate Response
Conventional
21.5 grams
Subcutaneous Accelerometer
---
Fixation
Model 2090
Programmer
Model 2090 Programmer
Helical coil or tines
Flexible
tines
1.5
10.3 Tyearst
1.5 T + 3
T
MR conditional
Battery Service Life
2.0
grams
lntracardiac Accelerometer
Heart Vessels & Stroke Σάββατο
07/03/2015
Workshop
I t 60
tProjected based on ADSRO 1 and Miera nditions
of 100%
pacing
a
bpm, 1.5 V at9.6
0.24 yearst
ms, and
What’s Needed for a Leadless Pacemaker?
• Catheter-based delivery system
• High density energy source
• Low power electronics
• Novel communication scheme
• Biocompatible materials
• Dependable fixation design
• Retrievability capability
Nanostim™ Leadless Pacemaker Makes Possible
Leadless Cardiac Pacing
The Nanostim™ VVIR pacemaker is introduced through the femoral vein
into the right ventricle.
• Energy efficient
– High-capacity CFx battery
– Lower resistance due to lack of lead
– Low-power conductive communication
•
•
Compatible with Merlin™ Patient Care System
Electrode design is identical to a St. Jude
Medical electrode with same steroid elution
• Designed to prevent dislodgement
– Double fixation: single turn helix (x 2 pullstrength) plus angled nylon sutures
– Radiographic indicator to ensure proper number
of turns
•
Tethered test mode for perioperative
evaluation
• Designed for retrievability
– Catheter-based retrieval system
Nanostim: The Device
•
•
Docking feature (A) for delivery, repositioning, and retrieval
Chemical cell (B)
– Standard cell has 3/4 the capacity of improved CFx
– LCP ASIC uses ¼ the current of standard ASICS
– Result: Same longevity with 3/16 the battery volume
•
Compact header (C) with no connector
– Single chip/ASIC senses, paces, and communicates
•
Helix (D) provides primary fixation
– Tines add secondary fixation
•
Electrode w/ steroid(E) paces, senses & communicates
D
E
The Nanostim™ Leadless Pacemaker Delivery System
• Delivery catheter
– Soft, flexible, deflectable catheter tip
designed to minimize complications
– Tethered feature
– Integrated protective sleeve
– 18 F
• Handle with four functions:
–
–
–
–
Steering the deflectable tip
Docking/undocking
Rotating the device
Releasing tether
• 18 F introducer
The Nanostim™ Leadless Pacemaker Retrieval System
• Similar to delivery system
– Flexible with deflectable tip
– Integrated protective sleeve
– 18 F
• Either single loop or triple loop
snare
• Handle with three functions:
1. Steering the deflectable tip for accurate passage
2. Grabbing and docking the LP
3. Rotating the LP
Nanostim™ Programmer Link
Conductive communication via
surface ECG electrodes
– No bulky antenna
– No added circuit module
– 50x less battery current
than RF systems
– Patented technology
First-in-man LEADLESS study
• Objective: Evaluate the safety and performance of the leadless
pacemaker
• Prospective, non-randomized, multicenter study conducted at 3
European centers
• A total of 33 patients were enrolled
–
–
–
–
Mean age of 77 years (53-91 years); 67% male
67% chronic AF and high degree AV block
18% sinus rhythm 2nd /3rd degree AV block with low activity or short lifespan
15% infrequent pauses or unexplained syncope
Procedure
Post-Procedure
2-week follow-up
6-week follow-up
• Femoral venous
access
• LP assessment &
programming
• 2 View X-ray of
pacemaker
• LP assessment &
programming
• Six-minute walk test
• LP assessment &
programming
• Six-minute walk test
• LP assessment &
programming
Reddy et al Circulation. 2014;129:1466-1471
3-, 6-, and 12month follow-ups
• LP assessment &
programming
LEADLESS Study: Delivery procedure1
•
•
Successful delivery in 32/33 patients (97%)*
Procedure Times
– Introducer in/out: 28 minute (range 11 – 74 min)
– Catheter in/out: 16 minute (range 3 – 57 min)
•
•
Time from procedure to hospital discharge: Mean 31 hrs (Range 17 – 113)
Number of times LP was repositioned: Mean 0.5 (Range 0 – 3)
Times LP repositioned
Number of patients
Percent of patients
0
23
70%
1
4
12%
2
4
12%
3
2
6%
*In one patient, there was cardiac perforation and tamponade which required surgical repair. On
post-operative day 5 after an uncomplicated surgical repair, the patient (who had atrial fibrillation
and was not adequately anticoagulated) had a large right-sided stroke and ultimately expired.
This event was medically adjudicated.
Reddy et al Circulation. 2014;129:1466-1471
LEADLESS Study: LP performance is reliable and
predictable at 12-months post-implant16
Reddy et al Circulation. 2014;129:1466-1471
NEW ENGLAND
JOURNAL of MEDICINE
The
l~'~~~~~~~~~o_R_J_G~IN~A_L_A~R-'[Percutaneous Implantation of an Entirely
Intracardiac Leadless Pacemaker
'J_c_L_E~~~~~~~~~-'11
Vivck Y. Reddy, M.D .. Derck V Exner. M.D .• M.P.H .. Daniel J Canullon. M.D
..
Rahul Dosh , M D.. T Jared Bunch, M.D., Gery F Tomasson: M
lmran Niazi, M.D., Kenneth Plunkitt,
M D., Rajesh Banker, M.D ..
D.,
James Pau
Porterfield,
M.D,M.D.,
JamesN.A.
E. Ip,
M.D.,
andIll,
Srinivas
R. Dukkipat.,
A. Friedman,
Mark
Estes,
M.D ,John
Ip, M.D. D.•
M the LEADLESS II Study Investigators*
for
HOVN'
lCHOOl
11""-AI
Of
n~o c•r.t
Heart Vessels & Stroke Σάββατο
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sheodp I doi:10.1056/NEJMoa1507192
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Heart Vessels & Stroke Σάββατο
07/03/2015 Workshop I
Leadless II Clinical Trial
Inclusion Criteria
Eligible subjects will meet all of the following:
•
Subject must have an indication as per guidelines:
Chronic AF with 2 or 3° AV or bifascicular BBB block, including slow
rates associated with AF
ventricular
NSR with 2 or 3° AV or BBB block and a low level of physical activity or short
expected lifespan
Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings
•
•
•
Subject >18 years of age; and
Subject has life expectancy of at least one year; and
Subject is not enrolled in another clinical investigation; and
•
Subject is willing to comply with clinical investigation procedures and agrees to return
for all required follow-up visits, tests, and exams; and
Subject has been informed of the nature of the study, agrees to its provisions and has
provided written informed consent, approved by the IRB; and
Subject is not pregnant and does not plan to get pregnant during the course of the study
Heart Vessels & Stroke Σάββατο
07/03/2015 Workshop I
Leadless II Clinical Trial
Patient Flow
526 P.1tient1
~,e: e:nro led in the 1tudy
I
Follow Patient for
30 days, then
withdraw
lOO~e:r• •n the croup o( 1n tl~I
~,1ta.111vt patltl'III tnrotlotd
( 226 ~t1't In ttie onso.nc
tnrollmtf'lt ,,oup
300 Und~nt l.mpfan1a1 on
226 Undttwf'nt 1rnplanu11io11
au empt
21 S Had succe-s~fulau~mpt
11 Had unsuccessful
~ttempt
~dPS1I.IC(:f1;'1ful atltmpl
d umuc.cNs(<JI aue-,npt
289 Unot'rwent follow-up
:l$«1>Sm~1 before: hosp tal
d~charge ~nd.it 2 ...At. 6 wk.
215 Unde~t follo~p
assessmen~ for <6 ntO
mo
30and)
Undetwet1t
HoJtet rnoni·
torin-gat 3 mo
]()()Were incl....ded in the
pt"ima,y whot1 at 6 mo of
folfow.1,.11p
aflod wef"e asse:s.st-d fot
p,imary cfficaq and :ufcty end
Conti nu~
'oDow-up
S26 \)t-.l'e ind1.1de-d in the
total
<..vnurt and we,e asses sed for
-devic.ede-vice-relateda.t'ld
no.1
retated seoces adverse events
potnls
M OUNT
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sheodp I doi:10.1056/NEJMoa1507192
Reddy07e/t03al/2, 0N15EW
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Leadless II Clinical
Primar
•
Safety (Intent-to-Treat
Trial
End oints
Analysis)
- 280 of the 300 patients achieved endpoint (93.3%; 95% CI= 89.9 to 95.9)
- This exceeded the performance goal of 86% (P<0.001)
• Efficacy (Intent-to-Treat
Analysis)
- 270 of the 300 patients achieved endpoint (90.0%; 95% CI= 86.0 to 93.2)
- This exceeded the performance goal of 85% (P = 0.007)
• Efficacy (Successful
implants)
- 289 patients with successful device implant
- 270 of the 289 patients achieved endpoint (93.4%; 95% CI= 89.9 to 96.0)
- This exceeded the performancegoal of 85% (P <0.001)
.+ Thus,
all endpoints were achieved
Heart Vessels & Stroke Σάββατο
15EW
orJksh
Reddy07e/t03al/2, 0N
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M eodp I doi:10.1056/NEJMoa1507192
Leadless II Clinical Trial
Device-Related
Primary Cohort
Ev•nt
Tobi Cohort
(N-300)
No.of
Event$
SAEs
(N-526)
No. of
Event
P3tients
Rate
No. of
Events
No.of
Patient$
Event
R•te
%
%
Total
22
20
6.7
40
34
6.5
Cardiac perforation
4
4
1.3
8
8
1.5
Cardiac tamponade with intervention
1
1
0.3
5
5
1.0
Cardiac perforation requirin2 intervention
1
1
0.3
1
1
0.2
Pericardial effusion with no intervention
2
2
0.7
2
2
0.4
I Vascular complication
Anhythmia during device implantation
arrest during implontotion
I Cardiopulmonary
procedure
Device dislodgement
1.1
Device migntion during ,mpl..ntation owing to
o.~ inad"(luatc
Pacing fixation
threshold elevation with retrieval and
implantation
Other*
4
4
1.3
6
1.1
6
2
2
0.6
3
3
0.6
0
0
0
1
1
0.2
s
5
0
0
1.7
0
4
4
1.3
3
3
0.9
6
6
2
4
2
4
0.8
or new device
10
10
1.9
* Includes:
MOUNT S11\J.AI
SCMOOt.
MEO CtNt
o,
ischemic stroke, angina pectoris, pericarditis, acute confusion & expressive aphasia,
dysarthria & lethargy post implant, contrast induced nephropathy, orthostatic hypotension with
weakness, left leg weakness duHrienagrt iV
mepsla
senlts, &proSbtraobklee Σpάuβlmβoαnτοary embolism, ischemic stroke
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H(O
0'
CINE
Freedom
from SADEs
Total Cohort (n=526)
l
-
.
.
.e
i..'
.
>
W
80
...··-·- ··--
·-····--·
······
·· ·--·-----
--· ····
·· -- ·-· ··- -----
----~
Total Cohort
-- -- -- -· ---- -- · -------- --- ·· ··· ···· · ·
97.5%
·· ·· LCB
- --------· ----··-·
">uc
~
60
c (
:,
0
..
I.
".
.
.e.
· ;
•
O
(I)
:
20
E
0
0
3
0
80
526
479
430
381
Events
23
34
34
Censo,-s
0
Success
97.5% LCB
0
'
~~
MS,SM
MOUNT
SIN.Al
SCMOOl Of
MEO
CINE
120
Follow-Up (Days)
.
No. at Risk
90
,s
o
180
334
308
2111
34
34
34
34
66
114
158
185
214
9S.6%
,
s
93.5%
93-5%
93.5%
93.5%
93.5%
93.5%
93.S%
91,1%
91,1%
91,1
%
91,1%
91
1%
91,1%
Heart Vessels & Stroke Σάββατο
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Battery Longevity:
Projected
500 Ohm Load
I 00
50
600 Ohm Load
8.8
9.8
10.6
11.
7
13.3
17.9
Assuming
vs ''Observed''
WIR at 60 bpm, and
14.
5
18.
9
output 2.5 V at 0.4 ms
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07/03/2015 Workshop I
Heart Vessels & Stroke Σάββατο
07/03/2015 Workshop I
Heart Vessels & Stroke Σάββατο
07/03/2015 Workshop I
• Pacing Mode VVIR
• Volume: 0.7Scc
• Mass· 22~
• Length . 24nun
• Width 20Fr
• Bipolar sensmg (17nun spacing)
---~
Active Fixation "Tines#
Electrically Inactive
Cathode (25mm1 CapSure Sen~
steroid eluting
----==Anode (27Dlllr
)
--~---
TiStoated
• Programmable
• Capture Management
• Rate Response
• Essential Diagnostics: battery status.
pacing threshold. pacing impedance, %
paced. longevity estimator
• Standard communication with 2090
programmer
Heart Vessels & Stroke Σάββατο
07/03/2015 Workshop I
• Device will be deactivated at EOL
Heart Vessels & Stroke Σάββατο
07/03/2015 Workshop I
Tether
Pill
Heart Vessels & Stroke Σάββατο
07/03/2015 Workshop I
tEu~opean Heart
Adva.nce, Access published June 4, 201
Journal
s
Eu r-opcan Heart Jou mal
1r., ...~
....... .,
-TTur•
RESEARCH
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CLINICAL
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gy
(Ml[gxQl;if
Early perforrnance
cardiac pacemaker:
Pac·ng Study
Philippe Ritter1•1 Gabor
Ra "Zali Omar5, LJluls
1
of a miniaturized leadless
ttre Miera Transcatheter
up to 720 patients at 70 centres worldwide
140 patients at 23 centres
uray ,
em.ens
e1nwen e: -
Lucas VA Boersma 7, Reinoud
.
yo,
oe11ma ,
, ~ops,
o
8., Larry Chinitz9,
E.
Miclha,el
Lloyd13,
11 John Hummel 12,
MonrtZhang
6,
Shu
1'0', Calambur Narasi1mhan
,
. 16,
T1imothy Alex.ander Simmers14', Andrew Vo:igt15, Verla Laager
Kurt Stromber-g1'6,
icra Transcatheter
Hattihew D. Bonner16,. Todd J. Sheldon16,, and Dwi'ght Reyn,0 lds11,
P,acing Study Group
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07/03/2015 Workshop I
Micra Transcatheter Pacing Study:
Patient Characteristics
Ritter et al. European Heart Journal (2015) 36, 2510–2519
Micra Transcatheter Pacing Study:
Patient Characteristics
Implant success rate was 100% (140/140)
Ritter et al. European Heart Journal (2015) 36, 2510–2519
Micra Transcatheter Pacing Study:
X-rays of various device positions in RAO view
• 107 (76.4%) devices were placed at the RV apex
• 33 (24%) were implanted at the anterior septum, midseptum,or
outflow tract
Ritter et al. European Heart Journal (2015) 36, 2510–2519
Micra Transcatheter Pacing Study:
Procedure or system-related adverse events from 140 implanted patients
30 total related adverse events
Dysrhythma
s
Events at device
placement
Events at groin puncture
suite
Other
site
Transient atrioventricular
block
Right bundle branch
block
Ventricular tachycardia
Pericardia! effusion
tamponad
Ventricular
fibrillation
without
e
Acute myocardial
infarction
Pericarditis
Non-cardiac chest pain
Angina pectoris
Arterial
pseudoaneurysm
Incision site
haemorrhage
Incision site
haematoma
Osteoarthritis
following
Incision site pain
procedure
lncisional drainage
Back pain during procedure
Vaso-vagal presyncope
Resulted in
death,
re-operation, or
hospitalization?
Total event rate, n (%)
N
o
No
No
No
4 (4
2,
2 (2
1,
1 (2
1.
prolonge >48 h
patient
eventd in
hospitalization
both
s
same
No
No
No
prolonge >48 h
1
hospitalization d
No
No
No
No
No
1 for
No
No
No
Dysuria following
Ritter et al. European
Heart Journal (2015) 36, 2510–2519
procedure
30 (26
patients,
2
29)
1.4
)
1.4
)
0.7
(1. )
1 (1 0.7
2, )
(1 0.7
2, )
3 (1
(3, 0.7
2, )
(2.
1 (1 0.7
1, )
(2 1.4
2 (1
,
1. )
(2
1 (2 1.4
.
1. )
(1
21)
.
(1 1.4
, )
(1 0.7
18.6%
)
Miera Transcatheter Pacing Study
One pericardial effusion was observed in a 90-year-otd female
who had undergone 18 repositioning because of inappropriate elec•
trical measurements, the highest number of repositioning observed
in the study. A pericardia( drainage was performed to drain approxi•
mately 250 cc of bload, although no tamponade was diagnosed. The
same patient experienced an acute myocardial infarction 3 days
post-implant and angiography revealed three-vessel coronary artery
disease. Transient complete AV block occurred in four patients and
resolved within seconds to a few hours. Three cases of transient AV
block required pacing via a temporary wire. The fourth resolved
Ritter P, et I. European Heart Journal doi:10.1093/eurheartj/ehv214
I
www.escardio.org
Heart Vessels & Stroke Σάββατο
07/03/2015 Workshop I
Micra Transcatheter Pacing Study:
Patient Characteristics
Ritter et al. European Heart Journal (2015) 36, 2510–2519
Miera Longevity Estimates
JO.I years@ . 1 5V,. 0 24 11,s, 500 oh111,
.
.
100%V
. 8 4 years@
.
. 0.4 11,s, 500 0/1111,
15V,
100%VP
1 111s, 500 oh111,
7 4years@2 0V, 024
100%VP
Longwry SimuL,toon (MC) ralo 60
.
.
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oor-~~~----=~-==:::::~r......,,:,;:====:=:=::;:::::::;:;,
..
..
00
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·
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.
.
Pl.PS 0.25
Pl.PS 0 4
·
80
l!l 70
.~.,, 60
-
-
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.
.
&
.
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ill.
l!I'
---·1)11
Ca~e
Fixation
MechaniSlll
Tilan
um
i
Enclosure
r n
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j
..
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50
Longevity
of 95% of dEMces =
••
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30
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Delivery Tool
".
Interface
Mean Longe-,,~ 25ms = 1 O o
20
"
"
""
.
Mean Longe-,,~.4r1lS =S 380
10
· .. .. .., .. ·.. ..
..
Heart Vessels & Stroke Σάββατο
07/03/2015 Workshop I
.
" . " ., .
1
·
10
.. ·
· ,.
. ... ".... .
... .
,
Future of Leadless Pacemakers
Potentiated by Device-to-Device Communication
Sudden Cardiac Death
Cardiac Resynchronization
CRT-0
Subcutaneous ICD Sy st m
MCVNT $1"'1.AI
SCMOOt.
11(01CINE
o,
Heart Vessels & Stroke Σάββατο
07/03/2015
Workshop
I J Am Coll Cardiol 66:1180 {2015)
Miller MA/ Neuzil P / Dukkipati
SR/
ReddyVY
MOVNT
$1111.AI
SCHOOi.
or
11[0
CINE
Nanostim: Implantation Procedure
Courtesy of St Jude Medical Inc.
Nanostim (St Jude Medical): The retrieval system
A deflectable catheter with snare (single or triple)
to retrieve the device
Courtesy of St Jude Medical Inc.
Nanostim: Retrieval Procedure
Courtesy of St Jude Medical Inc.
Implantation Case:
The delivery system places the device to RV apex
P. Neuzil ESC Congress Barcelona 2014
Implantation Case:
Device fixation procedure
P. Neuzil ESC Congress Barcelona 2014
Implantation Case:
Tug test
P. Neuzil ESC Congress Barcelona 2014
Implantation Case:
Contrast Injection
P. Neuzil ESC Congress Barcelona 2014
Implantation in an apically position of IVS
P. Neuzil ESC Congress Barcelona 2014
Inadvertent implantation to LV apex through a PFO
P. Neuzil ESC Congress Barcelona 2014
Freedom from SADEs
Primary Cohort (n=300)
~
L
100
~
~.
Primary Cohort
- - ···-· - --· ·
..
··· · -· · · -- ·· ···
· · ·--·· · ·- ···· · · · · ·· ·· -· · ··· · -· ·· ·- ··· ···· · ··· ·
·
- ·· ··· · · ·· · · ·· · --· · · ·· · ·· ·· ···· ·
--- ····· · -
97.5% LCB
0
30
60
90
120
150
180
Follow-Up (Days)
No-. at Risk
~~
MS,SM
MOUNT
SIN.Al
SCMOOl
Of
MEO
CINE
300
Events
11
C,enson
0
Success
96.3%
97.5% LCB
93.5%
278
267
265
264
263
262
20
20
20
20
20
20
13
15
16
17
18
93.3%
93.3%
93.3%
93.3%
93.3%
93.3%
89.8%
89.8%
89.8%
89.8%
89.8"'
89.8%
•
Heart Vessels & Stroke Σάββατο
15EWngorJkM
sheod
p I doi:10.1056/NEJMoa1507192
Reddy07e/t03a/l2, 0N
HCUNT Sl'VAI
SCMOOl Of t1
( 0 IC I HE
Miera TPS study: Baseline Characteristics
Patients (n=140)
Male gender
85, 61°/o
Age (years)
78 (21 94)
Height (cm)
-----~~-
Weight (kg)
170 (144 -190)
Body Mass Index
One or more comorbidity
Primary Indication
Bradycardia with permanent
or persistent AT/AF Sinus
node dysfunction
Atrioventricular block
Other reasons
"Median and ranges
reported
Heart Vessels & Stroke Σάββατο
07/03/2015 Workshop I
76 (41 148)
136,
26
(2097°/o
-45)
91, 65.0°/o
22,
15.7°/o
19,
13.6°/o
8,
5.7°/o
Serious Adverse Events in 140 pts
Resulting in death, re-operation,
or hospitalization
DYSRHYTHMIAS
N (pts,
o/o)
Transient AV block
No
2 (2, 1.4°/0)
RBBB
No
VT
No
VF
No
1 (1 0.7°/o)
,
1
0.7°/o
(1 )
1
,
0.7°/o
(1 )
1 ,(1 0.7°/o
1, )
CARDIAC
Pericardia effusion, no tamponade
(
Acute Ml
Pericarditis
OTHER
Arterial pseudoaneurysm
TOTAL
1
prolonged >48 hrs
hospitalization
for both events in
patient"
same
No
1 hospitalization prolonged >48 nrst
3 (2, 1.4°/o)
*Occurred in patient with 18 deployments who had 3 vessel
disease
Heart Vessels & Stroke Σάββατο
tResolved after thrombin injection
07/03/2015 Workshop I
0.7o/
1 (1
(1,0.7
, o)
%)
1 (1, 0.7°/o)
9 (8,
5.7°/o)