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COOK Medical Zenith Flex, Инструкция по эксплуатации

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6 SUMMARY OF CLINICAL STUDIES

6.1 Objectives

The primary objective of the clinical study was to evaluate the safety and 

effectiveness of a previous version of the device (Zenith AAA Endovascular 

Graft) as an alternative to open surgical repair in the primary treatment 

of infrarenal abdominal aortic aneurysms. Study hypotheses examined 

whether standard risk patients experienced less 30-day morbidity, non-

inferior 30-day survival rates, non-inferior 12-month survival rates, 

non-inferior 12-month treatment success and improved clinical utility 

measures compared to surgical control patients. Safety was determined by 

evaluating whether the Zenith AAA Endovascular Graft subjects would have 

reduced 30-day morbidity, non-inferior 30-day and 12-month survival and 

non-inferior 12-month treatment success compared to the subjects treated 

with open surgical treatment. Effectiveness was based on exclusion of the 

aneurysm including the absence of any endoleak, the absence of aneurysm 

enlargement (≥5 mm) and the absence of major device adverse events 

evaluated through one year follow-up.  Secondary objectives included an 

assessment of clinical benefit and quality-of-life measures.

6.2 Study Design

The U.S. clinical study was a multicenter, non-randomized study comparing 

standard medical risk patients who received an endovascular graft to an 

open surgical control. There were two additional study arms for high medical 

risk and roll-in treatment groups. Fifteen centers enrolled 200 standard risk, 

80 surgical control, 100 high risk and 52 roll-in patients. The control group 

included patients whose vascular anatomy may not have been suitable for 

endovascular AAA repair. Follow-up evaluations were scheduled for pre-

discharge, 1 month, 6 months, 12 months and 24 months. Patient follow-up 

and accountability at 1 month, 12 months and 24 months are presented in 

Table 6.2.1, as these were the primary data analysis time points. Imaging 

data provided in this summary are based on findings from an independent 

centralized image analysis laboratory (Core Lab), which reviewed CT scans 

and abdominal X-rays to assess aneurysm diameter changes, device and 

relative component migration, device integrity (wire and graft) and the 

presence and type of endoleaks. Clinical events were adjudicated by an 

independent clinical events committee, and safety was monitored by a data 

safety monitoring committee.

Surgical and Zenith standard risk patients met identical pathophysiologic 

risk criteria. The endovascular groups excluded circumferential thrombus 

in the proximal neck, proximal neck less than 15 mm in length, outer wall 

to outer wall proximal neck diameter less than 18 mm or greater than 28 

mm, severe proximal neck angulation, outer wall to outer wall iliac artery 

diameter less than 7.5 mm or greater than 20 mm at distal fixation site or 

iliac artery distal fixation site less than 10 mm in length.  

Patients were considered at higher risk for surgical repair if they had age 

greater than 80, baseline creatinine >2.0 mg/dl, home oxygen therapy, 

FEV

1

 <1 liter, ejection fraction <25%, disabling COPD, New York Heart 

Classification 3 or 4, hostile abdomen, dialysis, MI within last 6 months, 

medically intractable hypertension, previous stroke with residual deficit, 

cultural objection to receipt of blood or blood products, previous renal 

bypass surgery or inflammatory aneurysm.

Before enrolling patients into the pivotal trial, centers without Zenith AAA 

Endovascular Graft experience were required to treat initial patients under 

the supervision of a proctor. These roll-in patients were a combination of 

standard and high risk patients and were followed according to the same 

schedule as the patients in the pivotal trial.

Table 6.3.1 Comparison of Subject Characteristics

Item

Zenith Standard Risk

Surgical Standard Risk

P

 value

Zenith High Risk

Zenith Roll-in

Age (years)

71 ± 7

69 ± 7

.03

77 ± 7

74 ± 8

Gender male

94%

(187/200)

89%

(71/80)

.22

92%

(92/100)

90%

(47/52)

Current medical conditions

16%

(31/195)

25%

(19/76)

.12

24%

(23/96)

9.6%

(5/52)

Peripheral vascular disease
Hypertension

64%

(127/200)

83%

(65/78)

.001

68%

(67/99)

67%

(35/52)

Renal failure

0.0%

(0/197)

0.0%

(0/79)

>.99

5.2%

(5/97)

1.9%

(1/52)

COPD

20%

(39/199)

18%

(14/78)

.87

34%

(33/98)

22%

(11/51)

Thromboembolic event

4.5%

(9/199)

7.7%

(6/78)

.38

7.1%

(7/99)

1.9%

(1/52)

Liver disease

2.1%

(4/192)

5.1%

(4/79)

.24

1.0%

(1/99)

1.9%

(1/52)

Diabetes mellitus

12%

(24/199)

15%

(12/79)

.55

17%

(17/99)

14%

(7/51)

Insulin-dependent

17%

(4/24)

8.3%

(1/12)

.65

24%

(4/17)

43%

(3/7)

Previous medical conditions

39%

(74/192)

29%

(23/80)

.13

35%

(34/98)

35%

(18/52)

MI
Congestive heart failure

5.0%

(10/199)

12%

(9/78)

.07

16%

(16/100)

10%

(5/50)

Angina

49%

(98/198)

39%

(31/79)

.14

45%

(44/98)

44%

(23/52)

Arrhythmia

20%

(40/197)

22%

(17/78)

.87

28%

(27/98)

24%

(12/51)

Cerebrovascular disease

9.5%

(19/199)

16%

(13/79)

.14

20%

(20/99)

9.8%

(5/51)

Systemic infection

1.0%

(2/196)

0.0%

(0/78)

>.99

3.1%

(3/97)

0.0%

(0/49)

Cancer

22%

(43/200)

19%

(15/80)

.74

31%

(31/99)

29%

(15/51)

Family history of aneurysmal disease

16%

(24/150)

27%

(17/63)

.09

14%

(11/77)

26%

(10/38)

Previous surgery at site

10%

(20/200)

15%

(12/79)

.22

10%

(10/99)

14%

(7/51)

Previous radiation at site

0.5%

(1/197)

0.0%

(0/79)

>.99

2.0%

(2/100)

2.0%

(1/51)

Excessive alcohol use

3.6%

(7/193)

10%

(8/77)

.04

3.1%

(3/96)

4.0%

(2/50)

Tobacco use

10%

(20/193)

5.0%

(4/80)

14%

(13/96)

24%

(12/49)

Never smoked
Past smoker

69%

(133/193)

60%

(48/80)

.03

69%

(66/96)

57%

(28/49)

Still smokes

21%

(40/193)

35%

(28/80)

18%

(17/96)

18%

(9/49)

Due to inclusion criteria, high risk patients were older (

P

<.001), had more renal failure (

P

=.004), COPD (

P

=.01), congestive heart failure (

P

=.004) and 

cerebrovascular disease (

P

=.02) than standard risk patients.

Table 6.2.1 Patient Follow-Up and Accountability

1

Treatment

Zenith Standard Risk

Surgical Standard Risk

Interval 

1 mo.

12 mo.

24 mo.

1 mo.

12 mo.

24 mo.

No device

1

1

2

1

2

0

0

n/a

Conversion to open repair

0

2

2

2

2

n/a

n/a

n/a

Expired

1

7

17

2

3

n/a

Withdrawn/lost to follow-up

0

0

2

0

4

n/a

Available 

198

190

178

78

73

n/a

Site CT imaging

191

168

110

69

58

n/a

Core lab CT imaging

190

165

99

69

59

n/a

Site KUB imaging

179

153

108

n/a

n/a

n/a

Core lab KUB imaging

178

149

93

n/a

n/a

n/a

Site evaluated for endoleak

187

163

107

n/a

n/a

n/a

Core lab evaluated for endoleak

161

148

92

n/a

n/a

n/a

Site evaluated for aneurysm enlargement

n/a

149

104

n/a

n/a

n/a

Core lab evaluated for aneurysm enlargement

n/a

151

94

n/a

n/a

n/a

1

Data analysis sample size varies for each of the time points above and in the following tables. This variability is due to patient availability for follow-up, 

as well as quantity and quality of images available from specific time points for evaluation. For example, the number and quality of images available for 

evaluation of endoleak at 12 months is different than the number and quality of images available at 24 months due to variation in the number of image 

exams performed, the number of images provided from the clinical site to the Core Lab and/or the number of images with acceptable evaluation quality. 

Totals at time points are not cumulative, unless otherwise noted.

2

Totals at time points are cumulative.

6.3 Patient Demographics

Tables 6.3.1 and 6.3.2 compare the subject characteristics and initial aneurysm diameter of the Zenith AAA Endovascular Graft and open surgical population, 

respectively.

Содержание Zenith Flex

Страница 1: ...i Zenith Flex AAA endovaszkul ris graft Z Trak felvezet rendszerrel Haszn lati utas t s Endoprotesi addominale Zenith Flex con sistema di introduzione Z Trak Istruzioni per l uso Zenith Flex AAA endov...

Страница 2: ...SKY OBSAH Ilustrace 10 21 1 POPIS ZA ZEN 36 1 1 Komponenty aort ln ho hlavn ho t la a iliak ln ho ramena 36 1 2 Aplika n syst m hlavn ho t la 36 1 3 Aplika n syst m pro iliak ln rameno 36 1 4 P davn k...

Страница 3: ...S 64 1 1 Hauptk rper Aortenteil und iliakale Schenkel 64 1 2 Einf hrsystem f r Hauptk rper 64 1 3 Einf hrsystem f r iliakale Schenkel 64 1 4 Hilfskomponenten der Zenith endovaskul ren AAA Prothese 64...

Страница 4: ...bla 6 6 1 Cambio del di metro m ximo del aneurisma por intervalos 100 Tabla 6 6 2 Cambio del tama o del aneurisma y endofugas a los 12 meses 100 Tabla 6 6 3 Cambio del tama o del aneurisma y endofugas...

Страница 5: ...2 Raccordement du capuchon sup rieur 120 14 2 3 Mise en place et d ploiement du jambage iliaque homolat ral 120 14 2 4 Mise en place et d ploiement du jambage iliaque controlat ral 120 MAGYAR TARTALOM...

Страница 6: ...tent soprarenale 148 14 2 1 Rilascio dell estremit prossimale superiore del corpo principale 148 14 2 2 Innesto della calotta superiore 148 14 2 3 Posizionamento e rilascio della branca iliaca ipsilat...

Страница 7: ...odnogi biodrowej 177 1 4 Elementy pomocnicze do stent graftu wewn trznaczyniowego Zenith AAA 177 2 WSKAZANIA DO STOSOWANIA 177 3 PRZECIWWSKAZANIA 177 4 OSTRZE ENIA I RODKI OSTRO NO CI 177 4 1 Og lne 1...

Страница 8: ...olu o de problemas relativos expans o do stent supra renal 204 14 2 1 Expans o da parte proximal topo do corpo principal 204 14 2 2 Acoplagem da tampa superior 204 14 2 3 Coloca o e expans o da extrem...

Страница 9: ......

Страница 10: ...n nicht notwendigerweise die tats chliche Reihenfolge der Verfahrensschritte dar die zur Entfaltung dieser Vorrichtung erforderlich sind Die in Abschnitt 11 Gebrauchsanweisung und in Abschnitt 14 Fehl...

Страница 11: ...l Away h vely 6 Elz r csap 7 sszek t cs 8 Flexor bevezet h vely 9 Dilat tor cs csa 10 H vely oldalny l sa 11 Captor v rz scsillap t szelep 12 Sz rke pozicion l 13 Az ipsilateralis g els t dr tj nak ki...

Страница 12: ...neur gris 12 Canule interne 13 Jambage iliaque 1 K nusz 2 R gz t elem 3 Markol 4 Peel Away h vely 5 Elz r csap 6 sszek t cs 7 H vely 8 Dilat tor cs csa 9 H vely oldalny l sa 10 Captor v rz scsillap t...

Страница 13: ...rama il aca 4 Extensi n de cuerpo principal 1 Convertisseur 2 Obturateur iliaque 3 Extension de jambage iliaque 4 Extension de corps principal 1 Konverter 2 Iliacadug 3 Iliacasz r toldal ka 4 F graftt...

Страница 14: ...v teszik a graft anyag nak cs csi proxim lis orient ci j t A hossz sug rfog marker egy vonalba ker l a kontralater lis ggal 2 Fluoroszk pos k p 3 Fel ln zeti keresztmetszet 4 Kontralater lis g anterio...

Страница 15: ...race Illustrationer Abbildungen Ilustraciones Illustrations Illusztr ci k Illustrazioni Afbeeldingen Illustrasjoner Ilustracje Ilustra es Illustrationer 15 Fig 10 Fig 11 Fig 12 Fig 16 Fig 17 Fig 18 Fi...

Страница 16: ...lustrace Illustrationer Abbildungen Ilustraciones Illustrations Illusztr ci k Illustrazioni Afbeeldingen Illustrasjoner Ilustracje Ilustra es Illustrationer 16 Fig 20 Fig 24 Fig 26 Fig 19 Fig 25 Fig 2...

Страница 17: ...aufweitungs Prothesendichtungsstellen 1 1 Lugares de hinchado del bal n y sellado de la endopr tesis vascular 1 Sites de gonflage du ballonnet et d tanch it de l endoproth se 1 Ballon felt lt s graft...

Страница 18: ...king avsnitt 14 Rozwi zywanie problem w rozdzia 14 e en probl m st 14 Resolu o de problemas sec o 14 Fels kning avsnitt 14 1 View of trigger wire under tension 1 Pohled na napjat uvol ovac dr t 1 Visn...

Страница 19: ...dl ser wiren med den indre kanyle trukket tilbage mens den frig r sp nding 1 Ansicht des entspannten Ausl sedrahts bei zur ckgezogener innerer Kan le 1 1 Vista del alambre disparador con la c nula int...

Страница 20: ...en probl m st 14 Fejlfinding Afsnit 14 Fehlerbehebung Abschnitt 14 14 Soluci n de problemas apartado 14 D pannage Section 14 Hibakeres s 14 szakasz Guida alla risoluzione dei problemi Sezione 14 Oplo...

Страница 21: ...oting Section 14 e en probl m st 14 Fejlfinding Afsnit 14 Fehlerbehebung Abschnitt 14 14 Soluci n de problemas apartado 14 D pannage Section 14 Hibakeres s 14 szakasz Guida alla risoluzione dei proble...

Страница 22: ...eak An increase in aneurysm size and or persistent endoleak or migration may lead to aneurysm rupture Patients experiencing reduced blood flow through the graft limb and or leaks may be required to un...

Страница 23: ...when manipulating interventional and angiographic devices in the region of the suprarenal stent Use caution during manipulation of catheters wires and sheaths within an aneurysm Significant disturbanc...

Страница 24: ...80 001 55 55 100 62 32 52 0 365 days Cardiovascular2 5 0 10 200 14 11 80 02 19 19 100 3 8 2 52 Pulmonary3 1 5 3 200 16 13 80 001 6 0 6 100 0 0 0 52 Renal4 9 10 2 5 5 200 10 8 80 01 9 0 9 100 5 8 3 52...

Страница 25: ...r Graft experience were required to treat initial patients under the supervision of a proctor These roll in patients were a combination of standard and high risk patients and were followed according t...

Страница 26: ...1 0 1 100 0 0 0 52 Conversion 0 0 0 199 n a n a 0 0 0 100 0 0 0 52 0 30 days 31 365 days 5 1 0 2 199 n a n a 1 0 1 100 0 0 0 52 0 365 days 5 1 0 2 199 n a n a 1 0 1 100 0 0 0 52 Adverse events 20 40 2...

Страница 27: ...200 38 patients with events to 30 days 43 patients with events to 6 months 45 patients with events to 12 months Surgical Standard Risk N 80 34 patients with events to 30 days 38 patients with events t...

Страница 28: ...16 161 12 9 75 6 3 2 32 6 month1 8 7 15 172 11 8 70 8 6 3 35 12 month1 7 4 11 148 8 8 5 57 3 4 1 29 1 Includes both persistent endoleaks and new observations Tables 6 5 2 6 5 4 present the incidence o...

Страница 29: ...18 1 6 0 7 3 43 5 0 0 0 Increase 5 mm 1 1 100 0 0 0 0 0 0 0 0 6 7 AAA Related Secondary Interventions AAA related secondary interventions within the first year were performed in 11 of the Zenith stan...

Страница 30: ...onversion rupture and death see Section 5 1 Observed Adverse Events and Section 5 2 Potential Adverse Events The physician should complete the Patient I D Card and give it to the patient so that he sh...

Страница 31: ...125 155 140 170 20 25 26 30 82 112 96 126 111 141 125 155 140 170 20 27 28 32 82 112 96 126 111 141 125 155 140 170 20 29 32 36 95 125 113 143 131 161 149 179 22 1 Maximum diameter along the proximal...

Страница 32: ...re Captor Hemostatic Valve on the iliac leg introducer sheath is turned to the open position Fig 10 5 To deploy hold the iliac leg graft in position with the gripper on the gray positioner while withd...

Страница 33: ...ing i e per scanning sequence In non clinical testing the Zenith AAA Endovascular Graft produced a temperature rise of less than or equal to 1 4 C at a MR system reported whole body averaged specific...

Страница 34: ...ath NOTE The molding balloon may be inflated in the contralateral limb of the main body graft if additional graft stabilization is necessary CAUTION Do not inflate the balloon outside of the graft NOT...

Страница 35: ...with the gray positioner while withdrawing the iliac leg sheath and main body sheath together Figs 29 and 41 7 Under fluoroscopy and after verification of iliac leg graft position loosen the pin vise...

Страница 36: ...operaci je t eba zv it u pacient u nich se vyskytne zv t uj c se aneuryzma neakceptovateln zkr cen d lky fixace p ekryt c vy nebo komponenty a nebo endoleak Zv t en aneuryzmatu a nebo p etrv vaj c end...

Страница 37: ...tentu postupujte s extr mn opatrnost P i manipulaci s katetry dr ty a sheathy uvnit aneuryzmatu postupujte opatrn Velk naru en m e uvolnit fragmenty trombu kter mohou zp sobit embolizaci v dist ln ch...

Страница 38: ...19 100 3 8 2 52 Pulmon ln 3 1 5 3 200 16 13 80 0 001 6 0 6 100 0 0 0 52 Ren ln 4 9 10 2 5 5 200 10 8 80 0 01 9 0 9 100 5 8 3 52 St evn 5 1 5 3 200 3 8 3 80 0 36 1 0 1 100 1 9 1 52 R na6 5 5 11 200 13...

Страница 39: ...mn ze a u pacient se z n tliv m aneuryzmatem P ed zahrnut m pacient do pilotn studie byla pracovi t bez p edchoz praxe v implantaci endovaskul rn ho graftu Zenith AAA po d na aby provedla l bu prvn ch...

Страница 40: ...31 365 dn 0 0 0 199 1 0 1 100 0 0 0 52 0 365 dn 0 0 0 199 1 0 1 100 0 0 0 52 Konverze 0 0 0 199 0 0 0 100 0 0 0 52 0 30 dn 31 365 dn 5 1 0 2 199 1 0 1 100 0 0 0 52 0 365 dn 5 1 0 2 199 1 0 1 100 0 0 0...

Страница 41: ...8 pacient s p hodami do 6 m s c 41 pacient s p hodami do 12 m s c Po 1 m s ci Po 6 m s c ch Po 12 m s c ch n n n Zenith v tev se standardn m rizikem 162 81 0 154 78 5 133 77 4 Chirurgicky v tev se sta...

Страница 42: ...14 11 78 12 3 26 P ed propu t n m Po 30 dnech1 9 9 16 161 12 9 75 6 3 2 32 Po 6 m s c ch1 8 7 15 172 11 8 70 8 6 3 35 Po 12 m s c ch1 7 4 11 148 8 8 5 57 3 4 1 29 1 Zahrnuje jak p etrv vaj c endoleak...

Страница 43: ...71 3 4 0 24 1 4 0 16 0 0 0 Beze zm ny 18 1 6 0 7 3 43 5 0 0 0 Zv t en 5 mm 1 1 100 0 0 0 0 0 0 0 0 6 7 Sekund rn intervence souvisej c s AAA Sekund rn intervence souvisej c s AAA v prvn m roce byly pr...

Страница 44: ...douc p hody a st 5 2 Potenci ln ne douc p hody L ka m vyplnit identifika n kartu pacienta a p edat ji pacientovi aby ji pacient mohl neust le nosit u sebe Pacient mus kartu p edlo it p i ka d n v t v...

Страница 45: ...20 29 32 36 95 125 113 143 131 161 149 179 22 1 Maxim ln pr m r pod l m sta proxim ln fixace 2 Zm en pr m r aorty zaokrouhlete na nejbli mm 3 Volbu pr m ru mohou ovliv ovat tak dal aspekty V echny ro...

Страница 46: ...a i a sou asn vytahujte sheath Obr 18 a 19 Zajist te aby bylo zachov no p ekryt o jeden stent 6 Zastavte vytahov n sheathu jakmile je uvoln n dist ln konec iliak ln ho ramena graftu 7 Pod skiaskopick...

Страница 47: ...ho na cel t lo SAR 2 W kg za 15 minut sn mkov n tj na jednu sn mkovac sekvenci P i neklinick m testov n do lo u endovaskul rn ho graftu Zenith AAA ke zv en teploty maxim ln o 1 4 C p i m rn m absorbo...

Страница 48: ...37 39 54 a 56 mm m e b t nezbytn zv it pou it extenze ramena v m st bifurkace na prot j stran 3 Potvr te polohu dist ln ho konce iliak ln ho ramena graftu Podle pot eby reponujte iliak ln rameno graft...

Страница 49: ...n kanylou Obr 42 8 Zav ete hemostatick ventil Captor na zav d c m sheathu Flexor oto en m po sm ru hodinov ch ru i ek a na doraz 9 Znovu ov te polohu vodic ch dr t Sheath a vodic dr ty ponechte na m...

Страница 50: ...i fikseringsl ngde overlapning af kar og komponent og eller endol kage En stigning i aneurismest rrelse og eller en persisterende endol kage eller migration kan medf re ruptur af aneurismet Det kan v...

Страница 51: ...med fikseringsmodhager Der skal udvises meget stor forsigtighed ved manipulering af interventionelle og angiografiske produkter i omr det med den suprarenale stent V r forsigtig ved manipulering af ka...

Страница 52: ...39 80 0 001 55 55 100 62 32 52 0 365 dage Kardiovaskul r2 5 0 10 200 14 11 80 0 02 19 19 100 3 8 2 52 Pulmonal3 1 5 3 200 16 13 80 0 001 6 0 6 100 0 0 0 52 Renal4 9 10 2 5 5 200 10 8 80 0 01 9 0 9 100...

Страница 53: ...tilmelding af patienter i den afg rende unders gelse blev centre uden erfaring med Zenith AAA endovaskul r protese anmodet om at behandle initiale patienter under opsyn af en tilsynsf rende Disse ind...

Страница 54: ...52 0 365 dage 0 0 0 199 1 0 1 100 0 0 0 52 Konvertering 0 0 0 199 0 0 0 100 0 0 0 52 0 30 dage 31 365 dage 5 1 0 2 199 1 0 1 100 0 0 0 52 0 365 dage 5 1 0 2 199 1 0 1 100 0 0 0 52 U nskede h ndelser...

Страница 55: ...34 patienter med h ndelser op til 30 dage 38 patienter med h ndelser op til 6 m neder 41 patienter med h ndelser op til 12 m neder 1 m ned 6 m neder 12 m neder n n n Zenith standardrisiko 162 81 0 15...

Страница 56: ...3 2 32 6 m neder1 8 7 15 172 11 8 70 8 6 3 35 12 m neder1 7 4 11 148 8 8 5 57 3 4 1 29 1 Inkluderer b de vedvarende endol kager og nye observationer Tabellerne 6 5 2 6 5 4 pr senterer incidensen af f...

Страница 57: ...0 0 0 Stigning 5 mm 1 1 100 0 0 0 0 0 0 0 0 6 7 AAA relaterede sekund re interventioner AAA relaterede sekund re interventioner inden for det f rste r blev udf rt i 11 af Zenith standardrisiko 13 af Z...

Страница 58: ...h ndelser og Afsnit 5 2 Mulige u nskede h ndelser L gen skal udfylde Patientidentifikationskortet og give det til patienten s denne altid kan have kortet med sig Patienten skal referere til kortet n...

Страница 59: ...170 18 23 24 28 82 112 96 126 111 141 125 155 140 170 20 25 26 30 82 112 96 126 111 141 125 155 140 170 20 27 28 32 82 112 96 126 111 141 125 155 140 170 20 29 32 36 95 125 113 143 131 161 149 179 22...

Страница 60: ...olde iliaca benprotesen i position med gribeanordningen p den gr positioneringsanordning samtidig med sheathen tr kkes tilbage Fig 18 og 19 S rg for at overlapning svarende til en stentl ngde bevares...

Страница 61: ...nitlig absorptionsrate SAR for hele kroppen p 2 W kg ved 15 minutters scanning dvs pr scanningssekvens I ikke klinisk testning frembragte Zenith AAA endovaskul r protese en temperaturstigning p mindre...

Страница 62: ...ering af protesen er n dvendig FORSIGTIG Inflat r ikke ballonen uden for protesen BEM RK I snirklede kar kan aa iliacae internaes position ndres signifikant ved indf ringen af stive kateterledere og s...

Страница 63: ...erificering af iliaca benprotesens position l snes pin vise n og den indre kanyle tr kkes tilbage for at sammenkoble den konusformede dilatator med den gr positioneringsanordning Sp nd pin visen Opret...

Страница 64: ...en Gef operationen und der Verwendung dieser Prothese geschult wurden Spezifische Schulungsanforderungen werden in Abschnitt 10 1 rzteschulung beschrieben F r Patienten bei denen eine Aneurysmavergr e...

Страница 65: ...tzierung der Prothese und des gew nschten Verfahrensergebnisses unter Durchleuchtung erfolgen Die Verwendung der Zenith Flex endovaskul ren AAA Prothese mit Z Trak Einf hrsystem erfordert die Verabrei...

Страница 66: ...rische Insuffizienz Herzversagen mit Lungenembolie Pankreatitis mit Nierenversagen und Sepsis Blutung von Aneurysma im oberen Abdomen unbehandeltes AAA und multiples Systemversagen sowie 1 Studienfall...

Страница 67: ...rfahrenen Arztes behandelt werden Bei diesen Studienpatienten handelte es sich um Standardrisiko und Hochrisikopatienten die den gleichen Nachsorgema nahmen wie die als echte Studienteilnehmer operier...

Страница 68: ...ehend 3 0 6 199 0 0 0 80 0 19 4 0 4 100 9 6 5 52 Alle Todesf lle 3 5 7 199 3 8 3 80 0 99 9 0 9 100 11 5 6 52 0 365 Tage 2 3 4 mit AAA in Verbindung stehend 0 5 1 199 3 8 3 80 0 07 5 0 5 100 1 9 1 52 n...

Страница 69: ...Standardrisiko N 80 34 Patienten mit Ereignissen bis zum 30 Tag 38 Patienten mit Ereignissen bis zum 6 Monat 41 Patienten mit Ereignissen bis zum 12 Monat 1 Monat 6 Monate 12 Monate n n n Zenith Stan...

Страница 70: ...4 11 78 12 3 26 Vor der Entlassung 30 Tage1 9 9 16 161 12 9 75 6 3 2 32 6 Monate1 8 7 15 172 11 8 70 8 6 3 35 12 Monate1 7 4 11 148 8 8 5 57 3 4 1 29 1 Beinhaltet neu aufgetretene und persistierende E...

Страница 71: ...AA bezogene Sekund rinterventionen Mit dem AAA in Verbindung stehende sekund re Interventionen innerhalb des ersten Jahres wurden bei 11 der Zenith Standardrisikopatienten 13 der Zenith Hochrisikopati...

Страница 72: ...unterziehen kann es zu Impotenz kommen Der Arzt sollte die Patienten auf die Patienteninformation verweisen in der die w hrend und nach der Implantation der Prothese bestehenden Risiken beschrieben we...

Страница 73: ...atz aus der inneren Kan le entfernen und den Dilatatorspitzenschutz von der Dilatatorspitze abnehmen Die Peel Away Schleuse von der R ckseite des H mostaseventils entfernen Abb 8 Die distale Spitze de...

Страница 74: ...lemmschraube wieder anziehen um jede Ber hrung mit dem entfalteten suprarenalen Stent zu vermeiden HINWEIS Wenn sich der suprarenale Stent durch Vorschub der inneren Kan le der oberen Kappe nicht voll...

Страница 75: ...er Ballon vollkommen deflatiert ist VORSICHT Vor der Neupositionierung des Modellierungsballons muss das Captor H mostaseventil ge ffnet sein 6 Den Modellierungsballon zur berlappung des ipsilateralen...

Страница 76: ...rwacht werden kann welche Patienten die Zenith Flex endovaskul re AAA Prothese erhalten Vorschrift nach US Bundesgesetz 14 FEHLERBEHEBUNG HINWEIS Technische Unterst tzung durch einen Cook Produktspezi...

Страница 77: ...eben bis er an der oberen Kappe andockt Abb 23 24 und 38 HINWEIS Wenn ein Widerstand auftritt den grauen Positionierer leicht drehen und weiter vorsichtig vorschieben 4 Die Klemmschraube erneut anzieh...

Страница 78: ...lex Z Trak 3 Z Trak 14 French 16 French 0 035 0 89 mm Captor 1 4 AAA Zenith 4 AAA Zenith 2 Zenith Flex Z Trak 15 mm 32 mm 18 mm 60 45 10 mm 7 5 20 mm 3 AAA Zenith Flex Z Trak 4 4 1 AAA Zenith Flex Z T...

Страница 79: ...th 3 0 Tesla 720 Gauss cm 3 Tesla General Electric Excite 720 Gauss cm 1 5 Tesla 1 5 Tesla SAR 2 W kg 15 AAA Zenith 1 4 C SAR 2 8 W kg 15 Siemens Medical Magnetom 1 5 Tesla Numaris 4 Syngo MR 2002B DH...

Страница 80: ...2 80 0 08 0 0 0 100 0 0 0 52 8 11 11 21 200 31 25 80 0 001 20 20 100 19 10 52 91 181 198 86 67 78 0 25 79 77 98 86 44 51 31 365 2 2 5 5 198 3 8 3 78 0 69 5 1 5 98 2 0 1 51 3 0 5 1 198 1 3 1 78 0 49 4...

Страница 81: ...12 0 65 24 4 17 43 3 7 39 74 192 29 23 80 0 13 35 34 98 35 18 52 5 0 10 199 12 9 78 0 07 16 16 100 10 5 50 49 98 198 39 31 79 0 14 45 44 98 44 23 52 20 40 197 22 17 78 0 87 28 27 98 24 12 51 9 5 19 1...

Страница 82: ...0 0 0 52 0 365 0 0 0 199 1 0 1 100 0 0 0 52 0 0 0 199 0 0 0 100 0 0 0 52 0 30 31 365 5 1 0 2 199 1 0 1 100 0 0 0 52 0 365 5 1 0 2 199 1 0 1 100 0 0 0 52 20 40 200 43 34 80 0 001 32 32 100 27 14 52 0 3...

Страница 83: ...5 12 N 80 34 30 38 6 41 12 1 6 12 n n n Zenith 162 81 0 154 78 5 133 77 4 45 57 1 39 52 0 33 47 8 n P 0 001 6 4 4 6 4 7 AAA Zenith 6 4 4 6 4 5 6 4 6 6 4 7 6 4 4 Zenith Zenith Zenith 1 0 0 0 172 0 0 0...

Страница 84: ...12 1 7 4 11 148 8 8 5 57 3 4 1 29 1 6 5 2 6 5 4 30 6 12 6 5 2 1 N 179 N 172 3 N 148 1 2 1 2 1 2 17 31 17 2 3 4 3 3 4 5 2 I 2 8 5 4 0 0 0 0 0 0 0 0 1 7 3 1 0 0 0 0 0 7 1 1 I II 9 5 17 9 2 3 4 3 1 4 2...

Страница 85: ...0 0 0 0 6 6 3 24 Zenith N 90 Zenith N 31 Zenith N 21 N n N n N n 24 5 mm 71 3 4 0 24 1 4 0 16 0 0 0 18 1 6 0 7 3 43 5 0 0 0 5 mm 1 1 100 0 0 0 0 0 0 0 0 6 7 AAA AAA 11 Zenith 13 Zenith 5 8 Zenith 6 7...

Страница 86: ...enith 6 8 1 Zenith P Zenith Zenith min 221 6 67 3 304 5 102 7 0 001 218 9 69 6 213 9 57 7 min 153 2 56 3 238 7 92 2 0 001 153 5 58 6 155 9 43 2 5 0 10 200 84 67 80 0 001 12 12 100 3 8 2 52 ml 299 324...

Страница 87: ...n Cook Royal Flush Cook Beacon Cook Cook 10 5 10 5 1 1 2 mm 3 mm mm Fr 18 19 22 82 112 96 126 111 141 125 155 140 170 18 20 21 24 82 112 96 126 111 141 125 155 140 170 18 22 26 82 112 96 126 111 141 1...

Страница 88: ...mm 9 Captor Flexor 10 10 18 11 11 5 mm 11 1 6 1 2 12 11 1 7 1 2 mm 2 13 a Zenith Flex b c d 3 11 1 7 14 1 3 14 4 1 2 mm 15 16 1 2 cm 14 2 AAA Zenith Flex 5 11 1 8 1 2 3 17 4 1 5 Captor 10 5 18 19 6 7...

Страница 89: ...12 6 5 1 12 2 3 mm 3 mm 20 1 35 5 x 43 2 cm 14 x 17 12 2 1 11 1 11 Captor 27 1 2 28 37 39 54 56 mm 3 Captor 10 4 29 30 5 6 Captor 7 11 1 12 1 2 Captor 3 Captor 4 Captor 5 31 Captor 6 Captor 7 Captor...

Страница 90: ...re Excite 3 0 Tesla G3 0 052B SAR 3 0 W kg 2 8 W kg 20 cm GE Healthcare Excite 3 0 Tesla G3 0 052B 100 000 AAA Zenith Cook MedicAlert Foundation MedicAlert Foundation MedicAlert Foundation Internation...

Страница 91: ...39 54 56 mm 3 4 29 41 5 42 6 Captor Flexor 7 8 14 1 4 1 2 3 43 4 1 5 5 18 44 6 7 45 8 9 11 1 12 14 2 11 1 7 14 2 1 1 2 3 14 4 5 6 5 6 7 8 22 2 cm 46 9 10 11 12 37 13 14 15 16 14 2 2 1 22 2 3 23 24 38...

Страница 92: ...92 42 8 Captor Flexor 9 10 14 2 4 1 2 3 43 Spiral Z 30 mm 4 1 5 5 18 44 6 7 45 8 9...

Страница 93: ...y componente o endofugas deben considerarse otras intervenciones endovasculares o de una conversi n a reparaci n quir rgica abierta convencional despu s de la reparaci n endovascular inicial El aumen...

Страница 94: ...configuraci n anat mica y la posici n de la endopr tesis vascular pueden cambiar Vigile constantemente la posici n de la endopr tesis vascular y realice una angiograf a para comprobar la posici n seg...

Страница 95: ...0 99 1 0 1 98 3 9 2 51 Vasculares8 3 0 6 198 3 8 3 78 0 72 8 2 8 98 5 9 3 51 Ausencia de morbilidad 76 151 200 49 39 80 0 001 55 55 100 62 32 52 0 365 d as Cardiovasculares2 5 0 10 200 14 11 80 0 02 1...

Страница 96: ...de un monitor Estos pacientes de prueba incluyeron pacientes de riesgo normal y de alto riesgo y fueron seguidos de acuerdo con el mismo programa que los pacientes del estudio fundamental Tabla 6 3 1...

Страница 97: ...otura 0 0 0 199 0 0 0 100 0 0 0 52 0 30 d as 31 365 d as 0 0 0 199 1 0 1 100 0 0 0 52 0 365 d as 0 0 0 199 1 0 1 100 0 0 0 52 Conversi n 0 0 0 199 0 0 0 100 0 0 0 52 0 30 d as 31 365 d as 5 1 0 2 199...

Страница 98: ...nes a los 6 meses 41 pacientes con reacciones a los 12 meses 1 mes 6 meses 12 meses n n n Riesgo normal Zenith 162 81 0 154 78 5 133 77 4 Riesgo normal cirug a 45 57 1 39 52 0 33 47 8 n Pacientes vivo...

Страница 99: ...4 1 29 1 Incluye endofugas persistentes y nuevas observaciones Las tablas 6 5 2 6 5 4 presentan por intervalo de evaluaci n la incidencia de la primera aparici n de endofugas identificadas por el lab...

Страница 100: ...acionadas con el AAA En los sujetos tratados con la endopr tesis vascular Zenith durante el primer a o se realizaron intervenciones secundarias relacionadas con el AAA en el 11 de los de riesgo normal...

Страница 101: ...iesgos posibles durante la implantaci n del dispositivo y despu s de ella Los riesgos relacionados con el procedimiento incluyen complicaciones card acas pulmonares neurol gicas intestinales y hemorr...

Страница 102: ...de la vaina introductora Fig 6 Proceda a inyectar 20 ml de soluci n de lavado a trav s del dispositivo Deje de inyectar y cierre la llave de paso que hay sobre el tubo conector NOTA A menudo se utiliz...

Страница 103: ...ral del paciente antes de la implantaci n 1 Coloque el intensificador de im genes de forma que se muestren la arteria il aca interna contralateral y la arteria il aca primitiva contralateral 2 Antes d...

Страница 104: ...las indicaciones del fabricante en la zona del stent cubierto m s proximal y el cuello infrarrenal comenzando en posici n proximal y trabajando en direcci n distal Fig 31 AVISO Aseg rese de que el ba...

Страница 105: ...l alambre disparador deslizando el mecanismo de liberaci n del alambre disparador de la rama ipsilateral hasta separarlo del mango y a continuaci n extr igalo por su ranura sobre la c nula interior de...

Страница 106: ...a v lvula hemost tica Captor que hay sobre la vaina introductora Flexor gir ndola en el sentido de las agujas del reloj hasta el tope Fig 26 14 2 3 Colocaci n y despliegue de la rama il aca ipsilatera...

Страница 107: ...rurgie ouverte standard suivant le traitement endovasculaire initial chez les patients pr sentant une augmentation de taille de l an vrisme une diminution inacceptable de la longueur de la fixation ch...

Страница 108: ...s par ex une hydratation ad quate Lors du retrait de la gaine et ou du guide l anatomie et la position de l endoproth se peuvent changer Surveiller constamment la position de l endoproth se et r alise...

Страница 109: ...0 9 100 5 8 3 52 Intestinaux5 1 5 3 200 3 8 3 80 0 36 1 0 1 100 1 9 1 52 Relatifs la plaie6 5 5 11 200 13 10 80 0 08 5 0 5 100 5 8 3 52 Neurologiques7 1 0 2 200 2 5 2 80 0 32 1 0 1 100 3 8 2 52 Vascu...

Страница 110: ...on randomis s taient un m lange de patients risque standard et haut risque et taient suivis aux m mes intervalles que les patients de l essai pivot Tableau 6 3 1 Comparaison des caract ristiques des p...

Страница 111: ...0 3 100 0 0 0 52 Non en rapport avec un AAA 3 0 6 199 0 0 0 80 0 19 4 0 4 100 9 6 5 52 Tous d c s confondus 3 5 7 199 3 8 3 80 0 99 9 0 9 100 11 5 6 52 0 365 jours 2 3 4 En rapport avec un AAA 0 5 1 1...

Страница 112: ...v nements 30 jours 38 patients pr sentant des v nements 6 mois 41 patients pr sentant des v nements 12 mois 1 mois 6 mois 12 mois n n n Patients Zenith risque standard 162 81 0 154 78 5 133 77 4 Pati...

Страница 113: ...h non randomis s Endofuites 15 23 153 14 11 78 12 3 26 Avant la sortie 30 jours1 9 9 16 161 12 9 75 6 3 2 32 6 mois1 8 7 15 172 11 8 70 8 6 3 35 12 mois1 7 4 11 148 8 8 5 57 3 4 1 29 1 Comprend les en...

Страница 114: ...nde intention en rapport avec l AAA Des interventions de seconde intention en rapport avec l AAA au cours de la premi re ann e ont t r alis es chez 11 des patients Zenith risque standard 13 des patien...

Страница 115: ...isques en rapport avec l intervention comprennent des complications cardiaques pulmonaires neurologiques intestinales et h morragiques Les risques en rapport avec le dispositif comprennent occlusion e...

Страница 116: ...la gaine Peel Away de l arri re de la valve h mostatique Fig 8 Sur lever l extr mit distale du syst me et rincer la valve h mostatique par le robinet jusqu ce que du liquide sorte de l orifice lat ral...

Страница 117: ...pr vu est s lectionn pour tre ins r sur le c t controlat ral du patient 1 Positionner l intensificateur d image de fa on observer l art re iliaque interne controlat rale et l art re iliaque commune co...

Страница 118: ...5 Gonfler le ballonnet de modelage avec du produit de contraste dilu selon les directives du fabricant dans la zone de l endoproth se couverte la plus proximale et du collet sous r nal en commen ant e...

Страница 119: ...u positionneur gris se trouve 2 cm environ des marqueurs en or Fig 34 Le positionneur gris avanc fournit un soutien suppl mentaire la canule interne REMARQUE Maintenir une tension douce sur les fils d...

Страница 120: ...yst me de largage du jambage iliaque homolat ral injecter du produit de contraste par la gaine du corps principal pour rep rer l art re iliaque interne homolat rale 3 Utiliser l ensemble guide et gain...

Страница 121: ...t Az aneurysma m ret nek n veked se a perzisztens endoleak illetve a graft migr ci ja az aneurysma ruptur j hoz vezethet A graft g ban cs kkent v r raml st vagy sziv rg st tapasztal betegekn l m sodla...

Страница 122: ...land an monitorozza a graft helyzet t s sz ks g szerint v gezzen angiogr fi t annak ellen rz s re A Zenith Flex AAA endovaszkul ris graft egyik r sze egy r gz t horgokkal ell tott suprarenalis sztent...

Страница 123: ...5 3 200 16 13 80 0 001 6 0 6 100 0 0 0 52 Renalis4 9 10 2 5 5 200 10 8 80 0 01 9 0 9 100 5 8 3 52 B lrendszeri5 1 5 3 200 3 8 3 80 0 36 1 0 1 100 1 9 1 52 Seb6 5 5 11 200 13 10 80 0 08 5 0 5 100 5 8...

Страница 124: ...adv nyt netekkel j r stroke v r vagy v rk sz tm nyek alkalmaz s nak kultur lis alapon val elutas t sa kor bbi renalis bypass m t t vagy gyullad sos aneurysma A kulcsvizsg latba val betegfelv telt mege...

Страница 125: ...nap 0 0 0 199 1 0 1 100 0 0 0 52 0 365 nap 0 0 0 199 1 0 1 100 0 0 0 52 Konverzi 0 0 0 199 0 0 0 100 0 0 0 52 0 30 nap 31 365 nap 5 1 0 2 199 1 0 1 100 0 0 0 52 0 365 nap 5 1 0 2 199 1 0 1 100 0 0 0...

Страница 126: ...tegn l t rt nt esem ny a 12 h napig 41 betegn l t rt nt esem ny 1 h nap 6 h nap 12 h nap n n n Zenith standard kock zat 162 81 0 154 78 5 133 77 4 M t ttel kezelt standard kock zat 45 57 1 39 52 0 33...

Страница 127: ...32 6 h nap1 8 7 15 172 11 8 70 8 6 3 35 12 h nap1 7 4 11 148 8 8 5 57 3 4 1 29 1 Mind a perzisztens mind az jonnan megfigyelt endoleakeket belev ve A 6 5 2 6 5 4 t bl zat az endoleak els el fordul s n...

Страница 128: ...ak Endoleak Endoleak Adat N n N n N n Az aneurysma m ret ben bek vetkezett v ltoz s az elbocs t s el tti id pontt l a 24 h napig Cs kken s 5 mm 71 3 4 0 24 1 4 0 16 0 0 0 V ltozatlan 18 1 6 0 7 3 43 5...

Страница 129: ...gyobbod sa t r s jabb beavatkoz s s nyitott m t ti korrekci ra val tt r s esetleges sz ks gess ge ruptura s hal l l sd az 5 1 szakaszban Megfigyelt nemk v natos esem nyek s az 5 2 szakaszban Lehets ge...

Страница 130: ...r diszt lis cs cs t s fecskendezzen bl t folyad kot az elz r csapon t a v rz scsillap t szelepre mindaddig am g folyad k nem folyik ki a bevezet h vely cs cs hoz k zeli oldalny l sb l 6 bra Folytassa...

Страница 131: ...l 3 A kontralater lis iliacasz r bejuttat rendszer t vezesse fel az art ri ba Tolja lassan el re addig am g az iliacasz r legal bb az iliacasz r egy teljes sztentj vel azaz az iliacasz r proxim lis sz...

Страница 132: ...ebb 3 0 tesla A m gneses t r gradiens nek maximuma 720 gauss cm A nem klinikai rt kel s 3 tesl s MR rendszerrel General Electric Excite a sztatikus m gneses t r betegnek megfelel pontj ban vagyis a sz...

Страница 133: ...nalis sztentre h z djon 36 bra 10 Ellen rizze hogy az arany markerek a veseart ri k alatt helyezkednek el 11 T vol tsa el az els t dr tot 12 H zza vissza a h velyt am g a sz rke pozicion l elkeskenyed...

Страница 134: ...a f graftt rzs h vely be MEGJEGYZ S Amennyiben a graft tov bbi stabiliz l sa sz ks ges a form z ballont fel lehet t lteni a f graftt rzs kontralater lis g ban is VIGY ZAT A ballont tilos felt lteni a...

Страница 135: ...zione Z Trak deve essere usata esclusivamente da medici ed quipe debitamente addestrati nelle tecniche di interventistica vascolare con cateterismo e chirurgiche e nell uso specifico dei presenti disp...

Страница 136: ...e il rischio di contaminazione e di infezione dell endoprotesi stessa Mantenere invariata la posizione della guida durante l introduzione del sistema di inserimento L inserimento e il rilascio devono...

Страница 137: ...fficienza cardiaca Tabella 5 1 2 Eventi negativi1 nello studio clinico Zenith a rischio normale Riparazione chirurgica a rischio normale Valore P Zenith ad alto rischio Zenith di pratica Esenza da mor...

Страница 138: ...ostruttiva cronica invalidante con classificazione New York Heart Association 3 o 4 con addome ostile in dialisi con IM infarto miocardico negli ultimi sei mesi con ipertensione non trattabile dal pu...

Страница 139: ...psilaterale e controlaterale in un secondo tempo Tabella 6 4 2 Risultati principali Componente Zenith a rischio normale1 Riparazione chirurgica a rischio normale Valore P Zenith ad alto rischio Zenith...

Страница 140: ...1 pazienti con eventi a 12 mesi 1 mese 6 mesi 12 mesi n n n Zenith a rischio normale 162 81 0 154 78 5 133 77 4 Riparazione chirurgica a rischio normale 45 57 1 39 52 0 33 47 8 n pazienti in vita ed e...

Страница 141: ...nith ad alto rischio Zenith di pratica Endoleak 15 23 153 14 11 78 12 3 26 Prima della dimissione A 30 giorni1 9 9 16 161 12 9 75 6 3 2 32 A 6 mesi1 8 7 15 172 11 8 70 8 6 3 35 A 12 mesi1 7 4 11 148 8...

Страница 142: ...lati all AAA Nel caso dei pazienti trattati con l endoprotesi addominale Zenith gli interventi secondari correlati all AAA entro il primo anno sono stati eseguiti nell 11 dei pazienti a rischio normal...

Страница 143: ...quanto riguarda i rischi che esso pu correre durante o dopo l impianto del dispositivo I rischi correlati alla procedura includono complicanze cardiache polmonari neurologiche intestinali ed emorragic...

Страница 144: ...i e la biforcazione aortica 6 Distanza tra la biforcazione aortica e le arterie iliache interne siti di fissaggio 7 Gli aneurismi che si estendono all interno delle arterie iliache possono richiedere...

Страница 145: ...Sezione 14 2 Risoluzione dei problemi relativi al rilascio dello stent soprarenale NOTA Una volta rilasciato lo stent soprarenale munito di uncini di ancoraggio si sconsiglia di eseguire ulteriori ten...

Страница 146: ...Prima del riposizionamento confermare il completo sgonfiamento del palloncino ATTENZIONE La valvola emostatica Captor va aperta prima di riposizionare il palloncino dilatatore 6 Ritirare il palloncin...

Страница 147: ...Risoluzione dei problemi relativi al meccanismo di rilascio a filo di sicurezza ATTENZIONE Eseguire le seguenti operazioni solo se non si riesce a rimuovere il filo di sicurezza prossimale come descr...

Страница 148: ...A In caso di resistenza fare ruotare leggermente il posizionatore grigio e procedere delicatamente con l avanzamento 4 Serrare nuovamente il morsetto e ritirare la calotta superiore e il posizionatore...

Страница 149: ...ratief en in het gebruik van deze hupmiddelen Specifieke opleidingsverwachtingen worden beschreven in hoofdstuk 10 1 Opleiding van de arts Bijkomende endovasculaire interventies of conversie naar gebr...

Страница 150: ...cedure wordt gebruikt zo klein mogelijk is en dat preventieve behandelmethoden worden toegepast om verslechtering van de nierfunctie tegen te gaan bijv adequate hydratie Tijdens het terugtrekken van d...

Страница 151: ...52 Afwezigheid van morbiditeit 91 181 198 86 67 78 0 25 79 77 98 86 44 51 31 365 dagen Cardiovasculair2 2 5 5 198 3 8 3 78 0 69 5 1 5 98 2 0 1 51 Pulmonaal3 0 5 1 198 1 3 1 78 0 49 4 1 4 98 0 0 0 51...

Страница 152: ...n in de hoofdstudie Tabel 6 3 1 Vergelijking van kenmerken van proefpersonen Item Zenith standaardrisico Chirurgisch standaardrisico P waarde Zenith hoog risico Zenith oefenpati nten Leeftijd jaar 71...

Страница 153: ...0 0 199 0 0 0 100 0 0 0 52 0 30 dagen 31 365 dagen 0 0 0 199 1 0 1 100 0 0 0 52 0 365 dagen 0 0 0 199 1 0 1 100 0 0 0 52 Conversie 0 0 0 199 0 0 0 100 0 0 0 52 0 30 dagen 31 365 dagen 5 1 0 2 199 1 0...

Страница 154: ...ati nten met voorvallen tot 30 dagen 38 pati nten met voorvallen tot 6 maanden 41 pati nten met voorvallen tot 12 maanden 1 maand 6 maanden 12 maanden n n n Zenith standaardrisico 162 81 0 154 78 5 13...

Страница 155: ...61 12 9 75 6 3 2 32 6 maanden1 8 7 15 172 11 8 70 8 6 3 35 12 maanden1 7 4 11 148 8 8 5 57 3 4 1 29 1 Omvat zowel persistente endolekkages als nieuwe observaties In tabel 6 5 2 t m 6 5 4 wordt de inci...

Страница 156: ...aanden Afname 5 mm 71 3 4 0 24 1 4 0 16 0 0 0 Onveranderd 18 1 6 0 7 3 43 5 0 0 0 Toename 5 mm 1 1 100 0 0 0 0 0 0 0 0 6 7 AAA gerelateerde secundaire interventies AAA gerelateerde secundaire interven...

Страница 157: ...ding voor pati nten voor informatie over risico s die optreden tijdens en na de plaatsing van de prothese Proceduregerelateerde risico s zijn hart long zenuw darm en bloedingscomplicaties Prothesegere...

Страница 158: ...8 Houd de distale tip van het systeem omhoog en spoel via de afsluitkraan op de hemostaseklep totdat er vloeistof uit de zijopening bij de tip van de introducer sheath komt Afb 6 Ga door met spoelen t...

Страница 159: ...rventionele instrumenten wordt gemanoeuvreerd 5 Voer de contralaterale voerdraad op tot in de thoracale aorta 11 1 8 Plaatsing en ontplooiing van de contralaterale iliacale poot LET OP Controleer v r...

Страница 160: ...ximale bedekte stent en de infrarenale hals begin proximaal en werk in distale richting Afb 31 LET OP Voorafgaand aan herpositionering moet worden bevestigd dat de ballon geheel leeg is LET OP De Capt...

Страница 161: ...wire van de topkap af te klemmen en vast te zetten Afb 33 6 Draai de borgschroef los en voer terwijl u de binnenste canule en de trigger wire op hun plaats houdt de grijze pusher en sheath op in de pr...

Страница 162: ...contrastmiddel door de sheath van de main body om de ipsilaterale a iliaca interna te lokaliseren 3 Breng de ipsilaterale poot in met behulp van de voerdraad sheath van de main body NB Vanwege de wij...

Страница 163: ...eller vandring kan medf re aneurismeruptur Pasienter som opplever forminsket blodflow gjennom implantlemmet og eller lekkasjer b r muligens gjennomg sekund re intervensjoner eller kirurgiske prosedyre...

Страница 164: ...tvis meget stor forsiktighet ved manipulering av intervensjons og angiografianordninger i omr det med den suprarenale stenten Utvis forsiktighet ved manipulering av katetre vaiere og hylser inne i et...

Страница 165: ...9 3 51 Frav r av morbiditet 76 151 200 49 39 80 0 001 55 55 100 62 32 52 0 365 dager Kardiovaskul r2 5 0 10 200 14 11 80 0 02 19 19 100 3 8 2 52 Pulmon r3 1 5 3 200 16 13 80 0 001 6 0 6 100 0 0 0 52...

Страница 166: ...rende studien ble sentre uten erfaring i bruke Zenith AAA endovaskul rt implantat p lagt behandle initiale pasienter under oppsyn av en tilsynsf rende Disse innl ringspasientene var en kombinasjon av...

Страница 167: ...00 0 0 0 52 0 365 dager 0 0 0 199 1 0 1 100 0 0 0 52 Konvertering 0 0 0 199 0 0 0 100 0 0 0 52 0 30 dager 31 365 dager 5 1 0 2 199 1 0 1 100 0 0 0 52 0 365 dager 5 1 0 2 199 1 0 1 100 0 0 0 52 U nsked...

Страница 168: ...pasienter med hendelser til 30 dager 38 pasienter med hendelser til 6 m neder 41 pasienter med hendelser til 12 m neder 1 m ned 6 m neder 12 m neder n n n Zenith standardrisiko 162 81 0 154 78 5 133 7...

Страница 169: ...3 35 12 m neder1 7 4 11 148 8 8 5 57 3 4 1 29 1 Innbefatter b de persistente endolekkasjer og nye observasjoner Tabeller 6 5 2 6 5 4 angir insidensen av f rste tilfelle av endolekkasje pr evalueringsi...

Страница 170: ...100 0 0 0 0 0 0 0 0 6 7 AAA relaterte sekund re intervensjoner AAA relaterte sekund re intervensjoner innen det f rste ret ble utf rt hos 11 av Zenith standardrisiko 13 av Zenith h yrisiko og 5 8 av Z...

Страница 171: ...pen kirurgi ruptur og d dsfall se avsnitt 5 1 Observerte u nskede hendelser og avsnitt 5 2 Mulige u nskede hendelser Legen skal utfylle Pasient ID kort og gi det til pasienten slik at han hun kan all...

Страница 172: ...140 170 20 25 26 30 82 112 96 126 111 141 125 155 140 170 20 27 28 32 82 112 96 126 111 141 125 155 140 170 20 29 32 36 95 125 113 143 131 161 149 179 22 1 Maksimal diameter langs det proksimale fiks...

Страница 173: ...e 18 og 19 S rg for at overlapping med n stentlengde opprettholdes 6 Stopp tilbaketrekning av hylsen s snart den distale enden av iliaca benimplantatet utl ses 7 Under fluoroskopi og etter bekreftelse...

Страница 174: ...p 1 5 tesla Statisk magnetfelt p 1 5 tesla Maksimal helkropps gjennomsnittlig spesifikk absorpsjonsrate SAR p 2 W kg i l pet av 15 minutters skanning dvs per skanningssekvens Under ikke klinisk testin...

Страница 175: ...et kreves en overlapping p mer enn tre iliaca benstenter mer enn to iliaca benstenter for benlengder pa 37 39 54 og 56 mm kan det v re n dvendig vurdere bruke en benforlengelse i den motsatte sidens b...

Страница 176: ...oneringsenheten Stram klemmeskruen Oppretthold hylsens posisjon samtidig som den gr posisjoneringsenheten trekkes tilbake med fastgjort indre kanyle Fig 42 8 Lukk Captor hemostaseventilen p Flexor inn...

Страница 177: ...dotycz ce szkolenia s opisane w punkcie 10 1 Szkolenie lekarza U pacjent w u kt rych wyst puje powi kszanie si t tniak w niedopuszczalne zmniejszenie si d ugo ci miejsca mocowania zachodzenia na siebi...

Страница 178: ...c niedomog nerek mog by nara eni na zwi kszone ryzyko pooperacyjnej niewydolno ci nerek Nale y stara si ogranicza u ywan podczas zabiegu ilo rodka cieniuj cego i stosowa zapobiegawcze metody leczenia...

Страница 179: ...onarz dowej i 1 pacjent z grupy pr bnej podejrzenie niewydolno ci serca Tabela 5 1 2 Zdarzenia niepo dane1 w badaniu klinicznym Zenith ryzyko standardowe Operacja ryzyko standardowe Warto P Zenith ryz...

Страница 180: ...25 przewlek obturacyjn chorob p uc POChP prowadz c do inwalidztwa klas czynno ciow NYHA 3 lub 4 masywne zrosty w jamie brzusznej hostile abdomen dializ zawa mi nia sercowego w ci gu ostatnich 6 miesi...

Страница 181: ...1 0 1 100 0 0 0 52 0 365 dni 0 0 0 199 1 0 1 100 0 0 0 52 Konwersja 0 0 0 199 0 0 0 100 0 0 0 52 0 30 dni 31 365 dni 5 1 0 2 199 1 0 1 100 0 0 0 52 0 365 dni 5 1 0 2 199 1 0 1 100 0 0 0 52 Zdarzenia...

Страница 182: ...we N 80 34 pacjent w ze zdarzeniami w okresie do 30 dni 38 pacjent w ze zdarzeniami w okresie do 6 miesi cy 41 pacjent w ze zdarzeniami w okresie do 12 miesi cy 1 miesi c 6 miesi cy 12 miesi ce n n n...

Страница 183: ...y1 8 7 15 172 11 8 70 8 6 3 35 12 miesi cy1 7 4 11 148 8 8 5 57 3 4 1 29 1 Obejmuje przetrwa e i wie o rozpoznane przecieki wewn trzne Tabele 6 5 2 6 5 4 przedstawiaj cz sto pierwszorazowego wyst pien...

Страница 184: ...t tniaka od okresu przed wypisaniem ze szpitala do 24 miesi cy po wypisaniu Zmniejszenie 5 mm 71 3 4 0 24 1 4 0 16 0 0 0 Bez zmian 18 1 6 0 7 3 43 5 0 0 0 Zwi kszenie 5 mm 1 1 100 0 0 0 0 0 0 0 0 6 7...

Страница 185: ...rwotoczne Ryzyko zwi zane z urz dzeniem obejmuje zamkni cie przeciek wewn trzny powi kszenie si t tniaka z amanie mo liwo powt rnej interwencji i konwersji do otwartej operacji p kni cie i zgon patrz...

Страница 186: ...o c wki rozszerzacza Zdj koszulk Peel Away z tylnej cz ci zastawki hemostatycznej Rys 8 Unie dystaln ko c wk systemu i przep uka przez kranik w zastawce hemostatycznej do chwili gdy p yn pojawi si w b...

Страница 187: ...kaniuli wewn trznej nasadki ko c wki patrz punkt 14 2 Rozwi zywanie problem w dotycz cych rozpr ania stentu nadnerkowego UWAGA Po rozpr eniu stentu nadnerkowego z haczykami nie zaleca si podejmowania...

Страница 188: ...d ug zalece producenta w obszarze najbardziej proksymalnego pokrytego stentu i szyi podnerkowej zaczynaj c od ko ca proksymalnego i kieruj c si w stron dystaln Rys 31 PRZESTROGA Przed zmian po o enia...

Страница 189: ...WANIE PROBLEM W UWAGA Wparcie techniczne specjalist w ds produkt w firmy Cook mo na uzyska kontaktuj c si z miejscowym przedstawicielem firmy Cook 14 1 Rozwi zywanie problem w dotycz cych uwalniania d...

Страница 190: ...kaniul wewn trzn Rys 39 Pozostawi koszulk i prowadnik na miejscu 5 Zamkn zastawk hemostatyczn Captor na koszulce wprowadzaj cej Flexor obracaj c j do oporu zgodnie z ruchem wskaz wek zegara Rys 26 14...

Страница 191: ...devem ser consideradas no caso de doentes que apresentem aneurismas em expans o uma diminui o inaceit vel do comprimento de fixa o sobreposi o do vaso e do componente e ou fugas intra aneurismais Um...

Страница 192: ...diminuir o compromisso renal ou seja hidrata o adequada medida que a bainha e ou o fio guia s o retirados a anatomia e a posi o da pr tese poder o alterar se Monitorize constantemente a posi o da pr t...

Страница 193: ...13 80 0 001 6 0 6 100 0 0 0 52 Renal4 9 10 2 5 5 200 10 8 80 0 01 9 0 9 100 5 8 3 52 Intestinal5 1 5 3 200 3 8 3 80 0 36 1 0 1 100 1 9 1 52 Ferida6 5 5 11 200 13 10 80 0 08 5 0 5 100 5 8 3 52 Neurol g...

Страница 194: ...rurgia de bypass renal anterior ou aneurisma inflamat rio Antes do envolvimento dos doentes no ensaio principal foi exigido aos centros que n o tinham experi ncia com a pr tese endovascular AAA Zenith...

Страница 195: ...0 0 0 199 0 0 0 100 0 0 0 52 0 30 dias 31 365 dias 0 0 0 199 1 0 1 100 0 0 0 52 0 365 dias 0 0 0 199 1 0 1 100 0 0 0 52 Convers o 0 0 0 199 0 0 0 100 0 0 0 52 0 30 dias 31 365 dias 5 1 0 2 199 1 0 1 1...

Страница 196: ...34 doentes com epis dios aos 30 dias 38 doentes com epis dios aos 6 meses 41 doentes com epis dios aos 12 meses 1 m s 6 meses 12 meses n n n Zenith risco normal 162 81 0 154 78 5 133 77 4 Cirurgia ris...

Страница 197: ...tra aneurismais persistentes e novas fugas observadas As tabelas 6 5 2 a 6 5 4 apresentam a incid ncia da primeira ocorr ncia de fugas intra aneurismais por intervalo de avalia o conforme identificado...

Страница 198: ...8 1 6 0 7 3 43 5 0 0 0 Aumento 5 mm 1 1 100 0 0 0 0 0 0 0 0 6 7 Interven es secund rias relacionadas com AAA Foram realizadas interven es secund rias relacionadas com AAA no primeiro ano em 11 dos doe...

Страница 199: ...ispositivo Os riscos relacionados com o procedimento incluem complica es card acas pulmonares neurol gicas intestinais e hemorr gicas Os riscos relacionados com o dispositivo incluem oclus o fuga intr...

Страница 200: ...o lateral pr ximo da ponta da bainha introdutora Fig 6 Continue a injectar um total de 20 ml de solu o de irriga o atrav s do dispositivo Interrompa a injec o e feche a torneira de passagem no tubo de...

Страница 201: ...ser o no lado contralateral do doente 1 Posicione o intensificador de imagens de modo a mostrar a art ria il aca interna contralateral e a art ria il aca comum contralateral 2 Antes da introdu o do si...

Страница 202: ...ngiografia a cores se acess vel Em caso de suspeita de fugas intra aneurismais deve realizar se a confirma o por an lise espectral Devem ser obtidas imagens transversais e longitudinais do di metro m...

Страница 203: ...e liberta o do ramo ipsilateral para fora do punho e em seguida retire o atrav s da respectiva ranhura sobre a c nula interior do dispositivo 5 Com uma pin a de fixa o clampe e fixe a extremidade cort...

Страница 204: ...aca comum ipsilateral 2 Depois da introdu o do sistema de coloca o da extremidade il aca ipsilateral injecte contraste pela bainha do corpo principal para localizar a art ria il aca interna ipsilatera...

Страница 205: ...an beh va genomg sekund ra interventioner eller operationsingrepp 4 2 Patienturval behandling och uppf ljning Zenith Flex AAA endovaskul ra graft r utformat f r behandling av aortahalsdiametrar p mins...

Страница 206: ...saka distal embolisering eller ruptur av aneurysmet Undvik att skada graftet eller st ra graftets position efter placering om upprepad man vrering av graftet med instrumentation sekund rt ingrepp blir...

Страница 207: ...9 3 51 Avsaknad av morbiditet 76 151 200 49 39 80 0 001 55 55 100 62 32 52 0 365 dagar Kardiovaskul ra2 5 0 10 200 14 11 80 0 02 19 19 100 3 8 2 52 Lung 3 1 5 3 200 16 13 80 0 001 6 0 6 100 0 0 0 52 N...

Страница 208: ...llerade patienterna i huvudsakliga pr vningen kr vdes att centra utan erfarenhet av Zenith AAA endovaskul ra graft skulle behandla de f rsta patienterna under verinseende av en vervakare Dessa preklin...

Страница 209: ...0 100 0 0 0 52 0 30 dagar 31 365 dagar 0 0 0 199 1 0 1 100 0 0 0 52 0 365 dagar 0 0 0 199 1 0 1 100 0 0 0 52 Konvertering 0 0 0 199 0 0 0 100 0 0 0 52 0 30 dagar 31 365 dagar 5 1 0 2 199 1 0 1 100 0 0...

Страница 210: ...lser till 30 dagar 38 patienter med h ndelser till 6 m nader 41 patienter med h ndelser till 12 m nader 1 m nad 6 m nader 12 m nader n n n Zenith standardrisk 162 81 0 154 78 5 133 77 4 Kirurgisk stan...

Страница 211: ...12 9 75 6 3 2 32 6 m nader1 8 7 15 172 11 8 70 8 6 3 35 12 m nader1 7 4 11 148 8 8 5 57 3 4 1 29 1 Omfattar b de ih llande endol ckage och nya observationer Tabellerna 6 5 2 6 5 4 visar frekvensen av...

Страница 212: ...m 71 3 4 0 24 1 4 0 16 0 0 0 Of r ndrad 18 1 6 0 7 3 43 5 0 0 0 kning 5 mm 1 1 100 0 0 0 0 0 0 0 0 6 7 AAA relaterade sekund ra ingrepp AAA relaterade sekund ra ingrepp inom det f rsta ret utf rdes p...

Страница 213: ...nitt 5 1 Observerade biverkningar och avsnitt 5 2 Eventuella biverkningar L karen ska fylla i patient ID kortet och ge det till patienten s att han hon alltid kan b ra det med sig Patienten b r h nvis...

Страница 214: ...82 112 96 126 111 141 125 155 140 170 20 27 28 32 82 112 96 126 111 141 125 155 140 170 20 29 32 36 95 125 113 143 131 161 149 179 22 1 Max diameter l ngs proximala fixeringsst llet 2 Runda av uppm t...

Страница 215: ...kalisk graftbensstent dvs proximal stent i det iliakaliska graftbenet maximal verlappning av 1 5 stent inne i det endovaskul ra graftets huvudstomme OBS S kerst ll att Captor hemostasventil p inf rarh...

Страница 216: ...ik medelabsorptionshastighet SAR f r hela kroppen p 2 W kg f r 15 minuters skanning dvs per skanningsekvens Vid icke kliniska tester gav Zenith AAA endovaskul rt graft upphov till en temperatur kning...

Страница 217: ...ring blir n dv ndig VAR F RSIKTIG Fyll inte ballongen utanf r graftet OBS I slingrande k rl kan de inre h ftart rernas l ge ndras betydligt d styva ledare och hylssystem f rs in 2 F r det l ngsamt fra...

Страница 218: ...kanylen f r att koppla in den avsmalnande dilatatorn i den gr l gesst llaren under fluoroskopi och efter kontroll av det iliakaliska graftbenets position Dra t skruvstycket Bibeh ll hylsans l ge medan...

Страница 219: ......

Страница 220: ...lde voorwaarden MR sikker n r visse betingelser oppfylles Warunkowe stosowanie RM MR conditional poss vel realizar exames de rmn com este stent desde que sejam respeitadas determinadas condi es MR con...

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