PHYSICIAN'S LEAD MANUAL ACUITY™ X4 - Boston Scientific · 2019. 8. 19. · PHYSICIAN'S LEAD...
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PHYSICIAN'S LEAD MANUAL ACUITY™ X4 Coronary Venous Pace/Sense Lead IS4 Four-Pole Connector ACUITY™ X4 Straight Straight Tip Tined Fixation REF 4671, 4672 ACUITY™ X4 Spiral S Short Tip Spiral Tined + Spiral Fixation REF 4674, 4675 ACUITY™ X4 Spiral L Long Tip Spiral Tined + Spiral Fixation REF 4677, 4678 2018-10 92292829-01A
Transcript of PHYSICIAN'S LEAD MANUAL ACUITY™ X4 - Boston Scientific · 2019. 8. 19. · PHYSICIAN'S LEAD...
PHYSICIAN'S LEAD MANUAL
ACUITY™ X4 Coronary Venous Pace/Sense Lead IS4 Four-Pole Connector
ACUITY™ X4 Straight Straight Tip Tined Fixation REF 4671, 4672
ACUITY™ X4 Spiral S Short Tip Spiral Tined + Spiral Fixation REF 4674, 4675
ACUITY™ X4 Spiral L Long Tip Spiral Tined + Spiral Fixation REF 4677, 4678
2018-10
92292829-01A
(INFORMATION FOR USE) ................................................................ 1 (Device Description) .................................................................... 1
(Related Information) ...................................................................... 3 MRI (MR Conditional System Information) ....... 3
(Indications and Usage) ......................................................................... 4 (Contraindications) ................................................................................. 4 (Warnings) .............................................................................................. 4
(Precautions) ............................................................................ 6 (Potential Adverse Events) ........................................... 10
(PRE-IMPLANT INFORMATION) ........................................... 12 (Surgical Preparation) ................................................................ 12
(Items Included) ............................................................................ 12 (Additional Tools) ....................................................................... 13
(Accessories) .................................................................................... 13 (Vein Pick) ............................................................................. 13
(Radiopaque Suture Sleeve) ............ 13 ACUITY X4 (ACUITY X4 Flushing tool/Wire guide) .................................................... 13 DF-4 (DF-4 Lead Cap) ........................................................ 14 ACUITY X4 (ACUITY X4 Connector Tool) ......................... 14
(IMPLANTATION) ................................................................................. 14 (Overview of Lead Implant) ........................................... 15
(Lead Implant) ...................................................................... 16 (Electrical Performance) ................................................................ 34
(Tunneling the Lead) ..................................................... 34 (POSTIMPLANT) .............................................................................. 35
(Postimplant Evaluation) ..................................................... 35 (Explantation) ....................................................................................... 35
(SPECIFICATIONS) ................................................................................. 36 ( ) (Specifications (Nominal)) ...................................................... 36
(Lead Introducer)........................................................ 38 (Symbols on Packaging) ................................................. 38
Boston Scientific Corporation : ACUITY IMAGEREADY IROX
( ) + ( )
1. 2. ( ) 3. 4. IS4–LLLL 4 5.
46714672
46744675
46774678
E1
E2
E3
E4
1
(INFORMATION FOR USE)
(Device Description) ACUITY X4 4
(over-the-wire)IS41 4 4 IROX
(4 ) ( E1)
• —
• 3 ( )—
• IS4 4 — IS4-LLLL
(L ) • MRI — MRI
MRI(3 "MR Conditional (MR Conditional System
Information)") • IROX —
(IROX) • 3D — 3D
mid-base ( )3D
3 1
1. IS4 ISO 27186: 2010
2
• — (E1) 3(E2 E3 E4) 3 3
(ETFE)
• IS4 —
IS4
• —
• —
(37 9 " ( )") • —
• —
• — 3D
• —
• —
• —
• —
3
(Related Information)
MRI MRI Technical Guide
(Intended Audience)
MRI (MR Conditional System Information)
MRIMRI
MRI MRI Technical GuideMRI
MRI MRI
MRI Technical Guide
MRI (Implant-related MRI Conditions of Use) MRI MRI
MRI Technical GuideMRI
• MRI • MRI (
) • MRI • MRI
6 •
4
(Indications and Usage)
•
(Contraindications)
• 0.54mg
(Warnings) (General)
•
• 1
•
•
CPR
• (RV) RV
RV
•
(Handling) •
5
•
•
PSA ( ) ECG
•
• DF4-LLHH/LLHO2 IS4-LLLL3
( )
(Implant Related) • MRI Zone III American
College of Radiology Guidance Document for Safe MR Practices 4
Zone III MRI
MRI MRI MRIZone III IV
• (PSA)
•
•
(Post-Implant) • (MRI) MRI ( MRI
Technical Guide ) MRIMRI
2. DF4 ISO 27186: 2010 3. IS4 ISO 27186: 2010 4. Kanal E, et al., American Journal of Roentgenology 188: 1447-74, 2007.
6
MRI MRI Technical Guide
•
(Precautions) (Clinical Considerations)
•
Physicians' Desk Reference™ 5
(Sterilization and Storage) •
()
• 25°C(77°F) 15 30°C(59 86°F)
50°C(122°F) •
1 1 1 2
(Handling) •
•
•
•
5. Physicians' Desk Reference Thomson Healthcare, Inc.
7
•
(Implantation) •
•
•
•
•
•
•
•
8
• 3 3 1
6 •
•
•
•
•
•
•
•
•
6. Magney JE, et al. Anatomical mechanisms explaining damage to pacemaker leads, defibrillator
leads, and failure of central venous catheters adjacent to the sternoclavicular joint. PACE. 1993;16: 445–457.
9
•
•
•
•
•
(Hospital and Medical Environments) •
• •
•
•
•
• (RF)
(MTR)
10
•
•
•
•
PIC
(Follow-up Testing) •
(Potential Adverse Events)
( ) • (Acceleration of arrhythmias) • ( : ) (Adverse reaction to
procedure (e.g., bradycardia, general, respiratory, hypotension)) • (Air embolism) • (Allergic reaction) • (Arterial damage with subsequent stenosis) • (Bleeding) • (Bradycardia) • (Breakage/failure of the implant
instruments) • (Cardiac perforation) • (Cardiac tamponade) • (Chronic nerve damage) • (Component failure) • (Conductor coil fracture)
11
• (Coronary venous spasm) • (Death) • (Electrolyte imbalance/dehydration) • (Elevated thresholds) • (Erosion) • (Excessive fibrotic tissue growth) • ( ) (Extracardiac stimulation
(muscle/nerve stimulation)) • (Fluid accumulation) • (Foreign body rejection phenomena) • (Formation of hematomas or seromas) • (Heart block) • (Hemorrhage) • (Hemothorax) • (Inability to pace) • ( : ATP ) (Inappropriate therapy
(e.g., shocks and antitachycardia pacing [ATP] where applicable, pacing)) • (Incisional pain) • (Incomplete lead connection with
pulse generator) • (Infection including endocarditis) • (Lead dislodgment) • (Lead fracture) • (Lead insulation breakage or abrasion) • (Lead tip deformation and/or breakage) • (Malignancy or skin burn due to
fluoroscopic radiation) • ( : ) (Myocardial trauma (e.g.,
irritability, injury, tissue damage)) • (Myopotential sensing) • (Oversensing/undersensing) • (PMT) (Pacemaker-mediated tachycardia (PMT)) • (Pericardial rub effusion) • (Pneumothorax) • (Pulse generator and/or lead migration) •
(Shunting current or insulating myocardium during defibrillation with internal or external paddles)
• (Syncope) • (Tachyarrhythmias, which
include acceleration of arrhythmias and early, recurrent atrial fibrillation) • (Thrombosis/thromboemboli)
12
• (Valve damage) • (Vasovagal response) • (Venous occlusion) • ( : ) (Venous trauma (e.g., perforation,
dissection, erosion)) MRI MRI Technical Guide
• (Allergic reaction to contrast media) • (Prolonged exposure to fluoroscopic
radiation) • (Renal failure from
contrast media used to visualize coronary vein)
(PRE-IMPLANT INFORMATION)
(Surgical Preparation)
•
•
•
•
(Items Included) :
ACUITY X4 ACUITY X4
13
(Additional Tools)
• •
Deflectable tip(
) •
•
(Accessories)
(Vein Pick)
(Radiopaque Suture Sleeve)
:
(Model 4603)
:
ACUITY X4 (ACUITY X4 Flushing tool/Wire guide)
14
1. ACUITY X4
DF-4 (DF-4 Lead Cap)
ACUITY X4 (ACUITY X4 Connector Tool)
• • PSA
2. ACUITY X4
(IMPLANTATION) : MRI MRI
Technical Guide MRIMRI
MRI Technical Guide
: MRIMRI
15
(Overview of Lead Implant)
1.
2. 3.
4. 5. 6. 7. 8. 9.
(AP: Anterior Posterior) (LAO: Lateral Anterior Oblique) (middle cardiac vein) (left posterior vein) (left marginal/lateral vein) (anterior vein)
1
(AP: Anterior Posterior)
:
1.
2.
3.
4.
5.
6.
7.
8.
16
(LAO: Lateral Anterior Oblique)
:
1.
2.
3.
4.
5.
6.
7.
8.
:
(CABG)
(Lead Implant) 1.
0.081 (2.06mm)
• • •
17
• •
:
3.
: 33 1
7 (
) • • 0.89mm)
•
:
7. Magney JE, et al. Anatomical mechanisms explaining damage to pacemaker leads, defibrillator
leads, and failure of central venous catheters adjacent to the sternoclavicular joint. PACE. 1993;16: 445–457.
18
2.
:
:
3.
• ( ) • ( ) • •
(Lead Length Selection) (18 1 " ")
1.
(cm)
86 4671
95 4672
86 4674
95 4675
19
1. ( )
(cm)
86 4677
95 4678
:
:
(Lead Model Selection)
•
3 3 1
•
•
(Spiral Tip Configuration Models) 4
2.
(cm)
4674 4675 6.0
4677 4678 7.5
20
(4674 4675) (4677 4678)
4. ( )
(Straight Tip Configuration Models)
4 > 4.0cm
46744675
46774678
7.5 mm
7.5 mm
7.5 cm
6.0 cm
20.5 mm
7.5 mm
7.5 mm
35.5 mm
21
5. ( )
4.
(21 6 "( )")
6. ( )
0.014 (0.356mm)(hoop)
(22 7 "")
46714672
12 mm
12 mm4.0 cm
12 mm
22
7.
:
:
5.
: ( )
:
:
2
A (Method A) a.
b. ( )
23
c.
B (Method B) a.
(TVI)TVI (
) b.
c.
( 8cm)
:
:
:
:
6.
(Attaching the Connector Tool to the Lead) ACUITY X4
(24 8 "ACUITY X4")
24
8. ACUITY X4
(24 9 "E1 E4 ")
E1 E2 E3
E4
9. E1 E4
E1 E2 E3 E4
25
(Electrical Measurements)
(PSA)
:
17
3.
E1 E2 E3 E4
E2 Bi Bi Bi
E3 Bi Bi Bi
E4 Bi Bi Bi
RV ExtBi ExtBi ExtBi ExtBi
Uni Uni Uni Uni
Bi ExtBi Uni
26
4.
LV
Distal Zone
( ) E1 (- E1 (- E1 (- Proximal Zone ( ) E2 (- E2 (- E3 (- E3 (- E4 (- E4 (-
E1 (-
:
1. E1 2. E2 3. E3 4. E4 5. (PG) 6. RV
_
_
27
5.
LV RV
E1 (- (+) E2 (- (+) E3 (- (+) E4 (- (+)
E3 (-
:
1. E1 2. E2 3. E3 4. E4 5. (PG) 6. RV
_
_
28
6.
LV
E1 (- E2 (- E3 (- E4 (-
E2 (-)
:
1. E1 2. E2 3. E3 4. E4 5. (PG) 6. RV
(+) (–) PSA
(+) (-)
: (PSA)
64 ( 4 )
(26 3 "")
(PNS)
4
_
_
29
2 (1 1) (26
4 " ") ( )
PNS
: 4 RV
R
(29 7 "")
7.
R 3 mV
200
• PSA
• R R
•
PSA
:
30
•
PSA
(PSA)
PSA
(Checking for Lead Stability)
a. ( 8cm)
b. c.
d.
( )
7.
a. b.
c.
d.
:
e.
:
31
8.
:
:
:
:
:
(Percutaneous Implant Technique)
a. (31 10 "
")
10.
b. 2
c.
32
:
(Venous Cutdown Technique)
a.
b. c. (32
11 " ")
11.
d. 2
e.
:
9.
•
• PSA
33
•
:
: DF4-LLHH/LLHO8 IS4-LLLL9
( ) :
:
:
12. IS4
•
•
:
•
8. DF4 ISO 27186: 2010 9. IS4 ISO 27186: 2010
34
(Electrical Performance) 1. 2.
3. EGM
•
•
• LV 4.
(Tunneling the Lead)
1.
:
PSA ( ) ECG
2.
:
3.
:
4.
:
35
:
:
:
5.
•
•
(POSTIMPLANT)
(Postimplant Evaluation)
:
:
CPR :
(Explantation) :
: 1
36
• • ( )
•
:
• • • •
•
•
(SPECIFICATIONS)
( ) (Specifications (Nominal)) 8.
(cm)
86 4671
95 4672
86 4674
95 4675
86 4677
95 4678
37
9. ( )
IS4
IS4–LLLL
4
—
— 3
4674 4675 =
6.0 cm 4677 4678 = 7.5 cm
0.081 (2.06 mm)
:
LV 1 (E1) 4.1 mm2
LV 2 (E2) 8.3 mm2
LV 3 (E3) 8.3 mm2
LV 4 (E4) 8.3 mm2
(LV 1 = E1) (LV 2 = E2) (LV 3 = E3) (LV 4 = E4)
4671 4672 E1 = 3 mm
E1 E2 = 12 mm E2 E3 = 12 mm E3 E4 = 12 mm
4674 4675 E1 = 3 mm
E1 E2 = 20.5 mm E2 E3 = 7.5 mm E3 E4 = 7.5 mm
4677 4678 E1 = 3 mm
E1 E2 = 35.5 mm E2 E3 = 7.5 mm E3 E4 = 7.5 mm
:
1.8 mm (5.4 F)
1.7 mm (5.2 F)
1.3 mm (3.9 F)
0.9 mm (2.6 F)
38
9. ( ) ( )
Material ( ):
ETFE
Tecothane PEEK
MP35N™ a
IS4 MP35N™ a
IROX ( ) (Pt/Ir)
( )
( )
0.43 mg
Pt/Ir ( )
:
LV 1 (E1)
LV 2 (E2)
LV 3 (E3)
LV 4 (E4)
a. MP35N SPS Technologies, Inc.
(Lead Introducer) 10.
: 0.081 (0.21 cm)
(Symbols on Packaging) (39 11 " ")
39
11.
ID
CE
MR Conditional
X4 4671/4672/4674/4675/4677/4678 www.bostonscientific.jp © 2018 Boston Scientific Corporation or its affiliates. All rights reserved. 92035847-019 EN Europe 2018-01
