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PEARL REGISTRYPost Market Registry Real World Use of the AngioJet™ Thrombectomy System in the Peripheral Vascular System

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Overview

Venous (DVT)

Limb Ischemia (LI)

AV Access (AV)

PI-315422-AA JUN2015 © 2015 Boston Scientific Corporation or its affiliates. All rights reserved.


Overview

Objectives AngioJet Action Enrollment General Indications & Contraindications

Venous (DVT)

Limb Ischemia (LI)

AV Access (AV)

Overview Two-phase, prospective, non-randomized multi-center registry

PEARL I (January 2007 - April 2010): Followed patients for 3 months with documentation of symptomatic improvement after rheolytic thrombectomy (with mid-length catheters)

PEARL II (March 2010 - June 2013): Followed patient outcomes through 12 months after rheolytic thrombectomy with any AngioJet catheter

All patients were treated with AngioJet™ catheters

Patient history, procedural information, adjunctive treatments, outcomes and adverse events were collected

Patients were analyzed in arterial, venous & dialysis access indications

© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.


Overview


Venous (DVT)

Limb Ischemia (LI)

AV Access (AV)

Objectives Determine efficacy of thrombus removal from baseline to final angiogram/venogram

Evaluate clinical outcomes of treated patients at defined intervals of 3, 6 & 12 months

Characterize clinical events

Characterize treatment options used with the AngioJet™ System

Estimate rate of AngioJet Thrombectomy-related adverse events



Overview


Venous (DVT)

Limb Ischemia (LI)

AV Access (AV)

AngioJet™ Mechanism of Action The Bernoulli Effect explains the relationship between velocity and pressure.

Pressurized saline jets travel backwards to create a low pressure zone causing a vacuum effect.

Cross-Stream™ windows optimize the drawing action for more effective thrombus removal.

Thrombus is drawn into the catheter where it is fragmented by the jets and evacuated from the body.



Overview


Venous (DVT)

Limb Ischemia (LI)

AV Access (AV)

Enrollment I N=952 patients

371 (39%)Deep Venous Thrombosis (DVT)

410 (43%)Limb Ischemia (LI)

145 (15%)Hemodialysis Access (HA)

26 (3%) Other



Overview

Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons

Limb Ischemia (LI)

AV Access (AV)

DEEP VEIN THROMBOSISPresented by Dr. Mark Garcia at CIRSE 2013



Overview


Limb Ischemia (LI)

AV Access (AV)

DVT Baseline Characteristics

Demographics/Risk Factors

Age (years) 52 (±16.0)

Gender (male) 214 (58%)

Previous DVT 136 (37%)

Pre-existing caval filter 93 (25%)

Malignancy 34 (9%) current; 27 (7%) past

Pulmonary Embolism 44 (12%) current; 60 (16%) past

Recent Surgery 49 (13%)

Hypercoagulability 41 (11%)

Immobilization 30 (8%)

May Thurner 30 (8%)

Oral Contraceptives 22 (6%)

Recent Travel 9 (2%)

Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013



Overview


Limb Ischemia (LI)

AV Access (AV)

DVT Age by Onset


Acute

24 Hours 18 (5%)

256/371 (69%)

> 24 Hours and 7 Days 158 (43%)

> 7 Days and 14 Days 80 (22%)

Sub Acute > 14 Days and 30 Days 68 (18%) 68/371 (18%)

Chronic

> 30 days and 3 Months 33 (9%) 47/371 (13%)

> 3 Months and 6 Months 8 (2%)

> 6 Months 6 (1%)

69% of patients report symptom onset of ≤ 14 days



Overview


Limb Ischemia (LI)

AV Access (AV)

DVT Technique Subgroups

CDT, catheter-directed thrombolysisPMT, pharmacomechanical thrombolysisGarcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013

Treatment Frequency

AngioJet Thrombectomy alone (no lytic) “Rheolytic”

20 (5%)

AngioJet + Lytic by AngioJet “PMT”

129 (35%)

AngioJet “Rheolytic” + CDT 32 (9%)

AngioJet “PMT” + CDT 190 (51%)



Overview


Limb Ischemia (LI)

AV Access (AV)

DVT Adjuvant Therapies

CDT, catheter-directed thrombolysis. IVC, inferior vena cava. Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013

Therapy Frequency

Stent 119 (32%)

IVC Filter Placement 85 (23%)

Catheter Directed Thrombolysis 222 (60%)

Balloon Angioplasty 277 (75%)

Other Thrombectomy 22 (6%)

Surgical Decompression (ie . rib resection)

3 (<1%)

No CDT needed– 149 (40%)



Overview


Limb Ischemia (LI)

AV Access (AV)

DVT Duration of Procedure N=355*

*(355/371 had times recorded)


38% completed in ≤ 6 hours 75% completed in ≤ 24 hours

Time Period Frequency

6 Hrs 133 (38%)

> 6 Hrs & 12 Hrs 37 (10%)

> 12 Hrs & 24 Hrs 97 (27%)

>24 Hrs 88 (25%)



Overview


Limb Ischemia (LI)

AV Access (AV)

DVT Number of Lab Sessions N=359*

*(359/371 had # sessions recorded)


87% had 2 or less sessions

Session = In and Out of Interventional Suite

# of Sessions N(%)

1 123 (34%)

2 189 (53%)

3 40 (11%)

>3 7 (2%)



Overview


Limb Ischemia (LI)

AV Access (AV)

DVT Renal Test Comparisons

Wilcoxon Signed Rank Test*Paired analysisGarcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013

Analyte Pre-procedure

Mean

Post-procedure

Mean

Mean Difference*

PValue

BUN (N=235) 16.8 16.4 -0.4 0.1030

Creatinine (N=239) 1.1 1.2 0.1 0.0848



Overview


Limb Ischemia (LI)

AV Access (AV)

Venographic Results N=1295 vessels treated (p<0.0001)


0 10 20 30 40 50 60 70 80 90

100

Improved Unchanged Worsened

97

3 <1

% o

f T

reat

ed V

esse

ls


➦MORE


Overview


Limb Ischemia (LI)

AV Access (AV)

Venographic Results by Technique Subgroups (p<0.0001) N=1295 vessels treated

CDT, catheter-directed thrombolysisPMT, pharmacomechanical thrombolysis Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013

0 10 20 30 40 50 60 70 80 90

100

RheolyticThrombectomy

N=44

100

0 0

% o

f T

reat

ed V

esse

ls

PMTN=389

97

3 0

PMT+ CDTN=751

97

3 <1


+CDTN=111

Improved

Unchanged

Worsened

94

5 <1


➦➦MORE


Overview


Limb Ischemia (LI)

AV Access (AV)

Venographic Results clot age by symptom onset (p<0.0001)


0 10 20 30 40 50 60 70 80 90

100

<= 24 HrsN=64

100

0 0

% o

f T

reat

ed V

esse

ls

7-14 DaysN=306

97

3 0

1-7 DaysN=533

ACUTE DVT

97

3 <1

Improved

Unchanged

Worsened


➦➦MORE


Overview


Limb Ischemia (LI)

AV Access (AV)

Venographic Results clot age by symptom onset (p<0.0001)


0 10 20 30 40 50 60 70 80 90

100

>3 MonthsN=40

100

0 0

% o

f T

reat

ed V

esse

ls

30-90 DaysN=126

93

70

14-30 DaysN=226

SUBACUTE CHRONIC

97

2 1

Improved

Unchanged

Worsened


➦


Overview


Limb Ischemia (LI)

AV Access (AV)

Maintained Benefits DVT: Freedom from Rethrombosis

* Estimated by Kaplan Meier Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013

0 10 20 30 40 50 60 70 80 90

100

365 Days

% P

ts F

ree

fro

m R

eth

rom

bo

sis

180 Days90 Days

Days Post Procedure

9488

84


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Overview


Limb Ischemia (LI)

AV Access (AV)

Maintained Benefits DVT: Maintained Clinical Benefit*

* Estimated by Kaplan Meier Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013


➦➦MORE

0 10 20 30 40 50 60 70 80 90

100

365 Days

% P

ts M

ain

tain

ing

Clin

ical

Ben

efit

180 Days90 Days

Days Post Procedure

93

8278


Overview


Limb Ischemia (LI)

AV Access (AV)

Patient Quality of Life DVT: SF 12 QOL (PEARL II Only)


➦➦MORE

There are statistically significant improvements measured by the physical (p<0.0001) and mental (p<0.0001) components. The pretreatment physical scores differ significantly from the 3, 6 & 12 month follow ups QOL, quality of life


05

101520253035404550

6 MonthsN=153

QO

L M

ean

Sco

res

3 MonthsN=173

BaselineN=186

33.3

44.041.6

48.5

41.5

48.1

12 MonthsN=151

42.8

48.9

Physical

Mental


Overview


Limb Ischemia (LI)

AV Access (AV)

DVT Events

Events where the AngioJet™ could not be ruled out as a contributing factor.


➦➦MORE* Patient

CVA, cerebrovascular accident; PE, pulmonary embolism Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013

N Relationship to Event AngioJet Status

Arrhythmia 3 3 Unknown Resolved

Acute Renal Failure 1 Yes Resolved

Transient Renal Insufficiency 1 Unknown Resolved

Elevated Creatinine (1.1 to 1.7) 1 Unknown Resolved

PE (not treated) 1 Unknown Resolved

CVA (non-hemorrhagic) 1 Unknown Ongoing*

Bleeding requiring transfusion 1 Unknown Resolved

Hematoma/Bleeding at access 2 1 Unknown; 1 Yes Resolved

Hemolytic Anemia 1 Unknown Resolved

Hyperbilirubinemia 1 Yes Resolved

Leg Pain during procedure 1 Yes Resolved


Overview


Limb Ischemia (LI)

AV Access (AV)

PEARL Comparison Treatment of Lower Extremity DVT


*Garcia et al. J Vasc Interv Radiol 2015; 26:777-785 † Mewissen MW, Seabrook GR. Radiology 1999:211:39-49

‡ Enden , Haig Y. Lancet 2012:379:31-38

CDT, catheter-directed thrombolysis; CFV, common femoral vein; LMWH, low molecular weight heparin; PMT, pharmacomechanical thrombolysis

Results from different trials are not directly comparable. Information provided for educational purposes only.

PEARL* Venous Registry† CDT Standard

# of Patients 329 287 90 99

# of Sites 32 63 20

Prior DVT 40% 31% 10% 9%

Primary Treatment Angiojet™ Thrombectomy With or without PMT CDT CDT LMWH

Stent Placement 35% 33% 17% NA

Primary access Popliteal Popliteal Popliteal NA

Male 57% 48% 64% 62%

Age (mean) 52.2 yrs 47.5 yrs 53.3 yrs 50.0 yrs

Treatment Location Iliofemoral - femoral pop Iliofemoral - femoral pop CFV or iliofemoral

Limbs involved Left=62%; Right=38% Left=61%; Right=39% Left=60%; Right=40% Left=62%; Right=38%

CaVent‡

➦➦MORE


Overview


Limb Ischemia (LI)

AV Access (AV)



*Garcia et al. J Vasc Interv Radiol 2015; 26:777-785 †Mewissen MW, Seabrook GR. Radiology 1999:211:39-49 ‡Enden , Haig Y. Lancet 2012:379:31-38

CDT, catheter-directed thrombolysis; PMT, pharmacomechanical thrombolysis; PPS, power-pulse spray; RL, rheolytic; TPA, tissue plasminogen activator



Onsetof DVT

Symptoms

Acute 67% (≤14 days) 66% (≤10 days) 100% ≤21 days

Chronic 33% (>14 days) 16% (>10 days) NA

Acute & Chronic NA 19% NA

Primary Lytic TPA Urokinase TPA NA

CDT Drip Times (mean) 17 hrs 48 hrs 57.6 hrs (2.4 days) NA

ProcedureTimes

CDT (N=29) 40.9 hrs NA NA NA

CDT+PPS/RL(N=172) 22.0 hrs NA NA NA

PPS/RL (N=115) 2.0 hrs NA NA NA

Bleeding Complications 4.5% (major & minor combined)

11% (major);16% (minor)

22% (major & minor combined) 0%

CaVent‡

➦➦MORE


Overview


Limb Ischemia (LI)

AV Access (AV)



*Garcia et al. J Vasc Interv Radiol 2015; 26:777-785 †Mewissen MW, Seabrook GR. Radiology 1999:211:39-49 ‡Enden , Haig Y. Lancet 2012:379:31-38

CDT, catheter-directed thrombolysis; PPS, power-pulse spray; RL, rheolytic



Overall % Thrombus Removal 96% 83% 89% NA

By Lytic Groups: %thrombusremoval

CDT (N=28) 93% NA NA

CDT+PPS/RL(N=167) 97% NA NA

PPS/RL(N=113) 95% NA NA

Acute: % Thrombus Removal 97% 86% 89%

Chronic: % Thrombus Removal 95% 68% NA

Primary Patency NA 6 Mon = 65%;12 Mon = 60% 6 Mon = 65.9% 6 Mon = 47.4%

Freedom from Rethrombosis

6 Mon = 87%;12 Mon = 83% NA NA NA

CaVent‡

➦➦MORE


Overview

Venous (DVT)

Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis

AV Access (AV)

LIMB ISCHEMIAPresented by Dr. Ali Amin at Charing Cross 2014


Limb Ischemia Baseline Characteristics


Age (years) 65 (±13.0)


Hypertension 324 (79%)

Diabetes 139 (34%)

Hyperlipidemia 274 (67%)

CAD 183 (45%)

Smoking 153 (37%) current; 157 (38%) past

HX of Prior Interventions 270 (66%)

Amin. PEARL Registry Limb Ischemia. Charing Cross 2014


Overview

Venous (DVT)


AV Access (AV)



Overview

Venous (DVT)


AV Access (AV)

Limb Ischemia: Clot Age by Onset


Time of Onset N(%)

≤ 24 Hours 86 (21%)

> 24 Hours and ≤ 7 Days 138 (34%)

> 7 Days and ≤ 14 Days 59 (14%)

> 14 Days and ≤ 30 Days 45 (11%)

> 30 days and ≤ 3 Months 55 (13%)

> 3 Months and ≤ 6 Months 14 (3%)

> 6 Months 13 (3%)

69% of patients report symptom onset of ≤ 14 days



Overview

Venous (DVT)


AV Access (AV)

Limb Ischemia Technique Subgroups

CDT, catheter-directed thrombolysisPMT, pharmacomechanical thrombolysisAmin. PEARL Registry Limb Ischemia. Charing Cross 2014

Treatment Frequency


77 (19%)


151 (37%)


AngioJet “PMT” + CDT 66 (16%)



Overview

Venous (DVT)


AV Access (AV)

Limb Ischemia Adjuvant Therapies

CDT, catheter-directed thrombolysisAmin. PEARL Registry Limb Ischemia. Charing Cross 2014

Therapy Frequency

Stent 220 (54%)


Catheter Directed Thrombolysis 182 (44%)

Other Thrombectomy 44 (11%)

Atherectomy 14 (3%)

No CDT needed– 226 (56%)



Overview

Venous (DVT)


AV Access (AV)

Limb Ischemia Duration of Procedure N=397*

58% completed in ≤ 6 hours 80% completed in ≤ 24 hours

*(397/410 had times recorded) Amin. PEARL Registry Limb Ischemia. Charing Cross 2014

Time Period Frequency

6 Hrs 229 (58%)

> 6 Hrs & 12 Hrs 17 (4%)

> 12 Hrs & 24 Hrs 72 (18%)

>24 Hrs 79 (20%)



Overview

Venous (DVT)


AV Access (AV)

Limb Ischemia Number of Lab Sessions N=406*

*(406/410 had # sessions recorded) Amin. PEARL Registry Limb Ischemia. Charing Cross 2014

86% had 2 or less sessions

Session = In and Out of Interventional Suite

# of Sessions N(%)

1 227 (56%)

2 121 (30%)

3 44 (11%)

>3 14 (3%)



Overview

Venous (DVT)


AV Access (AV)

Limb Ischemia Renal Test Comparisons

Wilcoxon Signed Rank Test*Paired analysis


Analyte Pre-procedure

Mean

Post-procedure

Mean

Mean Difference*

PValue

BUN (N=263) 19.2 18.8 -0.4 0.0105

Creatinine (N=271) 1.4 1.4 0.0 0.5859



Overview

Venous (DVT)


AV Access (AV)

Angiographic Results N=947 vessels treated (p<0.0001)


0 10 20 30 40 50 60 70 80 90

100


93

6 <1

% o

f T

reat

ed V

esse

ls


➦➦MORE


Overview

Venous (DVT)


AV Access (AV)

Angiographic Results by Technique Subgroups (p<0.0001)

CDT, catheter-directed thrombolysisPMT, pharmacomechanical thrombolysis


0 10 20 30 40 50 60 70 80 90

100


N=155

90

100

% o

f T

reat

ed V

esse

ls

PMTN=296

97

3 <1

PMT+ CDTN=325

94

6 <1


+CDTN=171

Improved

Unchanged

Worsened

89

11<1


➦➦MORE


Overview

Venous (DVT)


AV Access (AV)

Angiographic Results clot age by symptom onset (p<0.0001)


0 10 20 30 40 50 60 70 80 90

100

% o

f T

reat

ed V

esse

ls

Chronic(>14 Days)

N=302

91

9<1

Acute(≤ 14 Days)

N=645

95

5 <1

Improved

Unchanged

Worsened


➦


Overview

Venous (DVT)


AV Access (AV)

Limb Salvage Events

Amin. PEARL Registry Limb Ischemia. Charing Cross 2014ABI, ankle-brachial index

Events Patients

Discharge 3 Month 6 Month 12 Month N(%)

Amputation 16 12 3 4 33(8%) a

Bypass Graft 15 14 3 3 34(8%) b

Vascular Surgeries 22 2 1 0 25(6%) a2 patients had 2 amputations. b1 patient had 2 bypass grafts.

Mean ± SD (median); N=68; p<0.0001

Baseline Discharge Change in ABI

0.32 ± 0.26 (0.36) 0.84 ± 0.27 (0.92) 0.52 ± 0.37 (0.54)

ABI by paired analysis

Limb Salvage rate was 89% (185/207) for the acute limb ischemia patients with Baseline Rutherford classifications of IIa, IIb and III.



Overview

Venous (DVT)


AV Access (AV)

Limb Ischemia Events

• All patients received dialysis. † Patient had a history of renal insufficiency. During hospitalization patient went into multi-organ failure resulting in death.‡ Patient was treated with hydration and antibiotics without sequelae


N Event Relationship to AngioJet Status

Arrhythmia 1 Unknown Resolved

Acute Renal Failure* 3 3 Unknown 2 Resolved; 1 treated†

Transient1 Renal Insufficiency 3 1 Yes; 2 Unknown Resolved

Bleeding requiring transfusion 7 7 Unknown Resolved

Hematoma/Bleeding at access 1 Yes Resolved

Pancreatitis‡ 1 Unknown Resolved

Hypotension 1 Unknown Resolved

Embolization 1 Unknown Resolved

Events where the AngioJet™ could not be ruled out as a contributing factor



Overview

Venous (DVT)


AV Access (AV)

Patient Quality of Life Limb Ischemia SF 12 QOL (PEARL II Only)

There are statistically significant improvements measured by the physical (p<0.0001) and mental (p<0.0001) components. The pretreatment physical scores differ significantly from the 3, 6 & 12 month follow ups

QOL, quality of life


05

101520253035404550

6 MonthsN=182

QO

L M

ean

Sco

res

3 MonthsN=186

BaselineN=202

30.6

45.1

39.1

48.4

38.8

48.4

12 MonthsN=167

37.6

48.9Physical

Mental



Overview

Venous (DVT)


AV Access (AV)

Acute Limb Ischemia (ALI) Propensity Matched Analysis*

An initial analysis identified differences in the ALI PEARL patients between those that received CDT and those that did not. (ie, PMT with CDT vs PMT without CDT)

The key differences were observed in:

Infrapopliteal involvement

The Rutherford Classification

Amount of thrombus

Graft involvement

As a result of the differences, a propensity score was estimated using patient characteristics

The score was used to match patients in each group so a comparison on outcomes could be made “Apples to Apples”

The result was 86 matched patients in each group

*Leung et al. J Endovasc Ther 2015; in press.


➦MORE


Overview

Venous (DVT)


AV Access (AV)

ALI Propensity Matched Analysis* Procedure Characteristics

1 Fisher’s Exact test or Wilcoxon Rank Sum test* Leung et al. J Endovasc Ther 2015; in press.

# (%) or Mean ±SD (Median)

PMT with CDT N=86

PMT without CDT N=86 P-value1

Total Lytic Dose (mg) 28.6 ± 18.3 (25.3)

10.8 ± 11.1 (8.7) <0.0001

Procedure Length (hrs)

25.2 ± 14.5 (21.7)

2.2 ± 2.7 (1.8) <0.0001

AngioJet ™ delivery of lytic 55 (64%) 61 (71%) 0.4160

Stent and/or PTA Use 67 (78%) 79 (92%) 0.0179

Embolic Protection Use 7 (8%) 6 (7%) 1.0000


➦➦MORE


Overview

Venous (DVT)


AV Access (AV)

ALI Propensity Matched Analysis* Endpoints

Timepoint PMT with CDT N=86

PMT without CDT N=86

p-value1 (p-value2) (p-value3)

Procedure Success - 74% 88% 0.0214

(0.0233) (0.0208)

Amputation-free survival

6 Mon 12 Mon

77% 72%

90% 87%

0.0285 (0.0203) (0.0345)

Freedom from amputation

6 Mon 12 Mon

83% 81%

96% 96%

0.0098 (0.0125) (0.0155)

Freedom from mortality

6 Mon 12 Mon

94% 91%

93% 91%

0.9487 (0.9441) (0.9557)

Freedom from bleeding

6 Mon 12 Mon

90% 90%

93% 93%

0.5914 (0.5627) (0.5974)

Freedom from Renal failure

6 Mon 12 Mon

95% 95%

93% 93%

0.7145 (0.6858) (0.5383)


➦➦MORE

1 p-value for group comparison in logistic regression for procedure success and Cox proportional hazards regression for the remaining endpoints.2 p-value for group comparisons that account for matching on propensity score. McNemar’s test was used for procedure success and the robust

sandwich estimate for the standard error was used in the Cox proportional hazards regression models.3 p-value for group comparisions in statistical model including infrapopliteal involvement (y/n) and history of peripheral arterial disease (y/n).4 Bleeding requiring transfusion.*Leung et al. J Endovasc Ther 2015; in press.


Overview

Venous (DVT)


AV Access (AV)

ALI Propensity Matched Analysis* Conclusions Results support the use of PMT (AngioJet™) as a first line treatment for ALI

ALI propensity analysis showed high rates of limb salvage were achieved in endovascular treatments that included AngioJet thrombectomy

Adding PMT provides rapid reperfusion to the extremity, a reduced procedure time with an acceptable risk profile without compromising limb salvage*Leung et al. J Endovasc Ther 2015; in press.


➦


Overview

Venous (DVT)

Limb Ischemia (LI)

AV Access (AV) Demographics Clot Age Treatment Subgroups Adjunctive Therapies Procedure Duration Angiographic Results HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency

HEMODIALYSIS ACCESSPresented by Dr. Eugene Simoni at VEITH 2013


Hemodialysis Access Baseline Characteristics

Simoni. PEARL Registry Hemodialysis Access. VEITH 2013


Age (years) 62 (±13.6)


Hypertension 82 (57%)

Diabetes 64 (44%)

Hyperlipidemia 44 (30%)

Coronary Artery Disease 45 (31%)

Smoking 17 (12%) current; 48 (33%) past


Overview

Venous (DVT)

Limb Ischemia (LI)



Hemodialysis Access Clot Age by Onset


Time of Onset N(%)

24 Hours 76 (52%)

> 24 Hours and 7 Days 65 (45%)

> 7 Days and 14 Days 1 (<1%)

> 14 Days and 30 Days 1 (<1%)

> 30 days and 3 Months 2 (1%)


Overview

Venous (DVT)

Limb Ischemia (LI)



Hemodialysis Access Technique Subgroups

CDT, catheter-directed thrombolysisPMT, pharmacomechanical thrombolysisSimoni. PEARL Registry Hemodialysis Access. VEITH 2013

Treatment Frequency


125 (86%)


19 (13%)



Overview

Venous (DVT)

Limb Ischemia (LI)



Hemodialysis Access Adjuvant Therapies


Therapy Frequency


Stent 59 (41%)

Fogarty Balloon/ Manual Embolectomy 45 (31%)

Other Lytic 14 (10%)

Other Mechanical Thrombectomy 3 (2%)

Catheter Directed Thrombolysis 1(<1%)


Overview

Venous (DVT)

Limb Ischemia (LI)



Hemodialysis Access Duration of Procedure

CDT, catheter-directed thrombolysisPMT, pharmacomechanical thrombolysisSimoni. PEARL Registry Hemodialysis Access. VEITH 2013


Overview

Venous (DVT)

Acute Limb Ischemia (ALI)

AV Access (AV) Demographics Clot Age Treatment Subgroups Adjunctive Therapies Procedure Duration Angiographic Results HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency Median Procedure Time 1.30 hrs

Treatment Median Procedure Time

Rheolytic Thrombectomy alone 1.25 hrs

AngioJet™ + Lytic (PMT) 1.41 hrs

Rheolytic Thrombectomy + CDT 14.0 hrs



Overview

Venous (DVT)

Limb Ischemia (LI)


Angiographic Results N=186 vessels treated (p<0.0001)


0 10 20 30 40 50 60 70 80 90

100


97

3 0

% o

f T

reat

ed V

esse

ls

➦➦MORE



Overview

Venous (DVT)

Limb Ischemia (LI)


➦➦MORECDT, catheter-directed thrombolysisPMT, pharmacomechanical thrombolysis Simoni. PEARL Registry Hemodialysis Access. VEITH 2013

0 10 20 30 40 50 60 70 80 90

100


N=162

98

2 0

% o

f T

reat

ed V

esse

ls

PMTN=23

100

0 0


+CDTN=171

Improved

Unchanged

Worsened

100

0 0

Angiographic Results by Treatment Groups (p<0.0001) N=186 vessels treated



Overview

Venous (DVT)

Limb Ischemia (LI)


➦aExcludes the vessels from one patient who had both an AV fistula and an AV graft but no follow up. Simoni. PEARL Registry Hemodialysis Access. VEITH 2013

0 10 20 30 40 50 60 70 80 90

100

GraftN=122

99

1 0

% o

f T

reat

ed V

esse

ls

FistulaN=61

97

3 0

UnkownN=1

100

0 0

Improved

Unchanged

Worsened

Angiographic Results by Access Type (p<0.0001) N=184a vessels treated



Overview

Venous (DVT)

Limb Ischemia (LI)



Hemodialysis Access Events

N Event Relationship to AngioJet

Status

Arrhythmia 2 2 Yes Resolved

Dissection of Vessel 1 Unknown Resolved

Events where the AngioJet™ could not be ruled out as a contributing factor



Overview

Venous (DVT)

Limb Ischemia (LI)


* Estimated by Kaplan Meier Simoni. PEARL Registry Hemodialysis Access. VEITH 2013

Maintained Graft/Fistula Survival


0 10 20 30 40 50 60 70 80 90

100

365 Days

% P

ts M

aint

aini

ng G

raft

183 Days91 Days

Days Post Procedure

96

80 76


Overview

Venous (DVT)

Limb Ischemia (LI)


* Estimated by Kaplan Meier Simoni. PEARL Registry Hemodialysis Access. VEITH 2013

Freedom from Rethrombosis / Restenosis with Intervention


0 10 20 30 40 50 60 70 80 90

100

365 Days

% P

ts F

ree

from

the

Even

t

180 Days90 Days

Days Post Procedure

83

53

37


Overview

Venous (DVT)

Limb Ischemia (LI)


*Kakkos SK, Haddad GK, Haddad J, Scully MM. J Endovasc Ther. 2008;15(1):91-102. Simoni. PEARL Registry Hemodialysis Access. VEITH 2013. National Kidney Foundation Clinical Practice Guidelines and Recommendations; 2006. KDOQI, Kidney Disease Outcomes Quality Initiative

KDOQI: minimum goal for percutaneous thrombectomy is 40% unassisted patency and functionality at 3 months

Hemodialysis Access Overall Patency

0102030405060708090

100

6 Months

% P

atie

nt

Pat

ency

3 Months1 Month

7278

47 45

12 Months

31 30

PEARL

Henry Ford*


AngioJet™ Ultra Console

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. INTENDED USE/INDICATIONS FOR USE: The Console is intended for use only in conjunction with an AngioJet Ultra Thrombectomy Set. Refer to the individual Thrombectomy Set Information for Use manual for specific clinical applications. CONTRAINDICATIONS: Refer to the individual Thrombectomy Set Information for Use manual for specific contraindications. WARNINGS and PRECAUTIONS: Use the AngioJet Ultra Console only with an AngioJet Ultra Thrombectomy Set. This Console will not operate with a previous model pump set and catheter. • Do not attempt to bypass any of the Console safety features. • If the catheter is removed from the patient and/or is inoperative, the waste tubing lumen, guide catheter, and sheath should be flushed with sterile, heparinized solution to avoid thrombus formation and maintain lumen patency. Reprime the catheter by submerging the tip in sterile, heparinized solution and operating it for at least 20 seconds before reintroduction to the patient. • Refer to the individual AngioJet Ultra Thrombectomy Set Information for Use manual for specific warnings and precautions. • Do not move the collection bag during catheter operation as this may cause a collection bag error. • Monitor thrombotic debris/fluid flow exiting the catheter through the waste tubing during use. If blood is not visible during console activation, the catheter may be occlusive within the vessel or the outflow lumen may be blocked. • Ensure adequate patient anticoagulation to prevent thrombus formation in outflow lumen. • Refer to individual Thrombectomy Set Instructions for Use manual for specific instructions regarding heparinization of the Thrombectomy Set. • The Console contains no user-serviceable parts. Refer service to qualified personnel. • Removal of outer covers may result in electrical shock. • This device may cause electromagnetic interference with other devices when in use. Do not place Console near sensitive equipment when operating. • Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. • To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. • Where the “Trapping Zone Hazard for Fingers” symbol is displayed on the console, there exists a risk of trapping or pinching fingers during operation and care must be exercised to avoid injury. • Do not reposition or push the console from any point other than the handle designed for that purpose. A condition of overbalance or tipping may ensue. • The AngioJet Ultra Console should not be used adjacent to or stacked with other equipment, and if adjacent or stacked use is necessary, the AngioJet Ultra Console should be observed to verify normal operation in the configuration in which it will be used. • Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT. • The use of accessories and cables other than those specified, with the exception of accessories and cables sold by Bayer HealthCare as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the Ultra Console. • MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding Electro-Magnetic Compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in the tables provided in the IFU. Adverse Events: Refer to the individual Thrombectomy Set Information for Use manual for specific observed and/or potential adverse events.

AngioJet, Solent, AVX, Power Pulse and Cross-Stream are trademarks of Boston Scientific.

Peripheral Interventions300 Boston Scientific WayMarlborough, MA 01752-1234www.bostonscientific.com

To order product or for more informationcontact customer service at 1.888.272.1001.

© 2015 Boston Scientific Corporationor its affiliates. All rights reserved.

PI-315422-AA JUN2015 © 2015 Boston Scientific Corporation or its affiliates. All rights reserved.

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