Risk Assessment of Local Lysis in CLI:Who benefits, who does not?

Ulrich Beschorner

Disclosure

Speaker name:

Ulrich Beschorner

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

x I do not have any potential conflict of interest

Clinical Case

77 y male, restpain since 24 h• History of multiple surgical+endovascular revascularizations

• Severe CAD, AFib, renal insufficiency (GFR 30)

• CK and myoglobin slightly elevated (CK 260 U/l)

• Still open wounds after last unsuccesful reopening attemt of a crural PTFE-BP 10 month ago

Clinical Case

rtPA-Local Lysis?

• Continuous infusion?

• Bolus technique?

• “Pulse spray” technique?

• Prior thrombectomy?

• Prior PTA?

• No lysis and new surgical attempt?

Lysis!

Local Lysis

• What dosage?

• How long?

• Dedicated side-hole catheter?

• Concomitand heparin?

2 mg rTPA bolus/ 1mg/h

over night

yes 5F 50 cm

yes via sheath PTT 60 s

RESULT

BK-Arterial Local Lysis

Registry

Bad Krozingen

2014 - 2015

Jan 2014 – Dec 2015, 6 experienced interventionalists

5676 PTAs

365 Lysis procedures

Patient Characteristics I

Age %

Age 67.68 y

SD ± 11.8 y

min 26 y

max 98 y

< 50 y 21 5.8

50 – 65 y 144 39.5

66 – 79 y 142 38.9

> 80 y 58 15.9

Patient Characteristics II

n %

Female 97 26.6

Arterial hypertension 300 82.2

Hyperlipidemia 287 78.6

Diabetes mellitus 144 39.5

Current smoker 151 41.4

Former Smoker 113 31.0

BMI

< 25 145 39.7

25-30 151 41.4

> 30 69 18.9

Patient Characteristics III

n %

Alcohol abuse 15 4.1

CVA 36 9.9

Insult/TIA 30 8.2

CAD 154 42.2

PCI 118 32.3

CABG 35 9.6

History of bleeding 26 7.1

Rutherford

n %

1 0 0

2 2 0.5

3 97 26.6

4 221 60.5

5 39 10.7

6 5 1.4

Patient Characteristics IV

n %

right 186 51.0

left 187 51.2

Venous-bypass 22 6.0

PTFE-bypass 56 15.3

Stent-occlusion 107 29.3

Viabahn-occlusion 15 4.1

Aneurysms 20 5,5

Intervention I

n %

Iliacs 39 10.7

SFA/APOP 313 85.8

BTK 281 77.0

Retrograde 273 74.8

Antegrade 92 25.2

Rotarex 293 80.3

Aspiration 95 26.0

Rotarex + aspiration 55 15.1

Intervention II

Actilyse

Ø Duration 18.79±8.6 h

Cumulative dose rtPA 20.47±9.6 mg

Min Dose 3.6 mg

Max Dose 63.3 mg

Jan 2014 – Dec 2015

365 Procedures

Successful: n = 337 (92.3%)

Not successful: n = 28 (7,7 %)

Re-Occlusions during inpatient stay: n= 8

Procedure could not be finished: n= 10

Successful after secondary attempt: n = 11

Rest: n = 10

Adverse event (AE)

160 Patients with AE

43.8 %

Serious adverse event (SAE)

128 Patients with SAE

35.1 %

Bleedings

n %

Major: → SAEHb-drop > 5 g/dl

56 15.3

Minor: → AEHb-drop 3 – 5 g/dl

110 30.1

Minimal: → AEhb-drop 2 – 3 g/dl

106 29.0

SAE

SAE

SAE n (%)

Bleeding at Puncture Site 42 (11.5)

Substitution of Erythrocytes 55 (15.1)

Compartment 22 (6.0)

GI-bleeding 8 (2.2)

MI 5 (1.4)

Amputation 11 (3.0)

Further access site complications 6 (1.6)

Death 11 (3.0)

others 13 (3.5)

SAE - Death

Age

1 Patient 67

2 Patients 75

1 Patient 77

7 Patients > 80

→ 10 of 11 death > 75 y

Mortality > 75 y: 10.3%

Mortality > 80 y: 12.1% !!!

Death: Multivariable analyses

Age over 80y: OR 4,95, 1.13 to 21.82, P=0.034

Former PCI: OR 8.26, 1.64 to 41.57, P=0.010

Blood transfusions: OR 6.40, 1.035-39.5, P= 0.046

TIMI-Major Bleeding:

Multivariable analyses

Cumulative rtPA Dose > 30 mg: OR 2.56, 1.25-5.23, P=0.010

BMI < 25: OR 1.94, 1.11-3.38, P=0,020

Lysis duration > 24 h: OR 3.40, 1.65-7.00, P= 0.001

Conclusion

• In combination with mechanical thrombectomy succes rate of local lysis is very good

• Frequency of hemorrhagic complications is still very high

• Local lysis in> 80 year old patients is associated with high mortality

• BMI 24 h and cumulative dose > 30 mg rtPAare associated with higher rate of major bleeding

Local lysis should only be used when urgently needed! Use other options whenever possible!

Risk Assessment of Local Lysis in CLI:Who benefits, who does not?

Ulrich Beschorner