A. Curnis

GARDONE RIVIERA 15 Aprile 2016

University of Brescia Medical School

Electrophisiology and Cardiostimulation Laboratory

Division of Cardiology

Italy

Patients with Device infection

BL Wilkoff; Texas Heart Inst J 2011

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The rate of implant Pts health profile

Procedere Mean age

Primary PM 75 + 12.1

Replacent PM 73 + 16.0

Primary ICD 66.2 +12.8

Replacent ICD 67.9 + 13.2

Age of PM Pts at Time of Implantation

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Device-related infections

Not related to Device type

Device –Tissue interaction

Recurrent infections during antibiotic therapy

Infections related to the implant procedure:

0.13 %-19.9 % PMs implants

0.8%- 13% ICDs implants (High variability from different Authors)

Pocket infections: 0.5-5%

Sepsi and endocarditis: 0.5-0.005%

Time to PM infection after implant: 2.5 weeks

Time to leads infection after implant: 33 weeks

Immunosoppression

(Diabetes, renal faliure, steroid therapy, cancer)

Vit K antagonist’s therapy

Post procedure Haematoma

Necessity of replacement Device and or for lead for

dislgment

Abandoned leads

Trombosis of the subclavian vein

Physician experience

Infection-related Factors

Infection’s mechanisms

Local contamination

(in the poket during implant)

Skin erosion after traumatisms

( with or without leads exposure)

Blood contamination (Methastatic)

Prognosis

Without device explant:

66% mortality

With device explant:

24 to 28% mortality

Parry G et al,PACE 1991;14:1251-7

Klug D,Circulation 1997;95:2098-107

Microbiology

Staphylococci (72-95%):

-St. Aureus (early infection)

-St. Epidermidis (late infection)

Others: Enterococcus

Streptoccocus

Proteus

Klebsielle

E. Coli

Pseudomonas aeruginosa

Fungi (rare)

Others….

percutaneous removal of CIEDs in patients with IE withlarge vegetations.

Aim:

•in-hospital morbidity and mortality related to percutaneous removal

of vegetations ≥20 mm.

•8 cases with a follow-up period of 20 months.

• We removed 100% of leads in the study population.

Conclusions:

• Transvenous extraction of pacing leads with larger vegetations is a feasible

technique.

•There was a tendency toward symptomatic pulmonary embolism in patients with

vegetations larger than 20 mm;

•morbidity and mortality were not influenced

Clin. Cardiol. 35, 4, 244–249 (2012)

ICD lead with vegetation greater than 41 × 12.5 mm (512 mm2)

The resulting pulmonary embolus produced a 33 × 20 mm pulmonary infarction

without hemodynamic or respiratory compromise

PACE 2006; 29:910–913

Lead’s Endocarditis

AngioVac® Circuit

Simple veno-veno EC

circuit

No reservoir

Centrifugal pump

Inline filter

Transparent provide

immediate visual feedback

Real-time reinfusion of

shed blood

Ensures hemodynamic

stability

Preserves blood volume

MASTER E&E

Tricuspid Vegetation Goldman, et al – Lankenau Hosp, PA

Tricuspid vegetation Goldman, et al – Lankenau Hosp, PA

Devices infections are more frequent

Key point is to identify the pathogen responsible for infection

Mandatory is a target antibiotic therapy

The complete removal of the system is required to eradicate

infection

Key points:

Different situations of device infection

Three different aspects of the same

problem :

A) edema of the pocket

B) skin retraction and initial necrosis

without device exposure

C) skin erosion with system exposure

Implant’s complications

1990-1999

PM 28% at 10 years

ICD 40% at 8 years

15 - 40% Venous trombosis

Problems of assistance

Infected CIEDs Non infected

CIEDs

p

National

incidence (USA)

31256 631422 NS

Age (mean) 67 ± 16 66 ± 16 NS

Females 34% 26% 0.008

In hospital stay

(days)

11 ± 10

4 ± 3

< 0.001

Hospital

mortality

5.2%

1.0%

< 0.001

Data related of 2004-2006

Voigt A; PACE 2010

Patients more at risk

Pz with infection (n = 75)

Controls (n = 75)

Adjusted OR (multivariate)

Device revision (leads and device)

60%

33%

3.67 (1.51 – 8.96)

eGFR < 60 ml/min 32% 11% 4.64 (1.48 – 14.62)

Anticoagulants Use*** 48% 21% 2.83 (1.20 – 6.68)

Lekkerkerker JC; Heart 2009

Early diagnosis and prognosis -1- Variable Group A Group B

Fever > 38 ° C 81% 14%

PAS < 90 mmHg 68% 19%

Leukocytes >

10000/mm3

97%

33%

Positive blood

cultures

100%

0%

Positive pocket

cultures

19%

57%

Leads vegetations

68%

0%

Valvular vegetations

19%

5%

Local involvement

of the pocket

0 – 13%

43% - 90%

Group A: signs of systemic infection

Group B: signs of local infection

Viganego F; Am J Cardiol 2012

Group A (n = 31) Group B (n = 21) p Value

Time from implant(years) 3.1 ± 2.5 5.5. ± 4.8 0.02

N° of extracted leads 1.9 ± 0.8 2.1 ± 0.9 NS

Days of in-hospital stay before

procedure 7.6 ± 6.3 1.3 ± 1.4 < 0.001

Laser use 18 (58%) 15 (71%) NS

Partial success 1 (3.2%) 2 (9.5%) NS

Procedural complications 3 (9.6%) 2 (9.5%) NS

Discharged patients 22 20 < 0.001

Days after procedure 15.1 ± 12.2 4.5 ± 4.5 0.003

Length of stay(days) 21.7 ± 14 5.7 ± 5.3 < 0.001

In-hospital mortality 9 (29%) 1 (4.7%) 0.02

Days after procedure 8.4 ± 8.3 6* (unique value) NS

Viganego F; Am J Cardiol 2012

Early diagnosis and prognosis -2-

Level Raccomandation

Class 1 In all the patients shoud be done almost two blood cultures before the beginning of

the antibiotic therapy or before the procedure of extraction

Class 1 Once the extraction, should be sent to culture the tissue that surrounds the

generator and the tips of leads

Class 1 Patients with suspected CIED infection who have positive blood cultures or who

have negative blood cultures but already in the course of antibiotic therapy prior to

sampling, should undergo transesophageal echocardiogram

Class 1 Patients with endocarditis on leads, should undergo transesophageal echo to

highlight endocarditis on the left valves. Exception can be done in pediatric

patients, in which the echo TT may be sufficient

Class 2a Patients with CIED who develop fever or positive blood cultures unexplained should

be seen by a cardiologist or an infectivologist

Class 3 The fine-needle aspiration of the pocket of the device should not be performed as a

diagnostic step for suspected CIED

Baddour LM; Circulation 2010

RACCOMANDATION

Diagnostic Flow-chart - 1 Initial evaluation and empiric antibiotic therapy

Chemistry exams:

Blood count Electrolytes Sieric creatinine ESV PCR 2 set blood cultures

To decide timing of antibiotic therapy

Systemic signs Poket inflammation (cellulitis, chronic draining sinus, swelling)

System exposition

Begin an antibiotic therapy for Gram negative and St. Aureus methicillin-resistant

Is possible the extraction of the system within 24 h)

No

Do not administer antibiotics

since the pre-operatory time

Yes

Dababneh AS, Sohail MR; Clev Clin J Med 2011

Diagnostic Flow-chart – 2 To determinate the duration of therapy

Blood culture and pockets’ swab

Culture positive, clinical signs of endocardities

or previus antibiotic therapy Negative blood cultures

Pocket infection System exposition

Antibiotics for 10-14 days*

Antibiotics for

7-10 days*

Echo TE

Valvular vegetations

Leads vegetations Negative

Guidelines for treatment of bacterial endocardieties

Osteomyelitis or septic venous thrombisis

Not complicated St. Aureus Others

Antibiotics for 4 – 6 weeks*

Antibiotics for 2 – 4 weeks*

Antibiotics for 2 – 4 weeks*

Antibiotics for 2 weeks*

* Time is calculated from the day of procedure

Dababneh AS, Sohail MR; Clev Clin J Med 2011

Survival

Group 2 (Malf. + Occl.)

Group 1 (Infections)

p = 0.022

Infected WITHOUT vegetations

Infected WITH vegetations

General population Infected patients

p = 0.04

Relative Risk- Univariate analysis

RR 95% CI p value

Diabetes mellitus 1.53 1.02 – 2.29 0.005

Infection 7.96 1.10 – 63.7 0.018

Blood cultures positive 1.68 1.18 – 2.40 < 0.001

Vegetations seen by

Echo

1.35 1.01 – 1.81 0.011

Anemia (Hb < 12 g/dl) 1.40 1.07 – 1.85 0.02

KI (crea ≥ 1.8 mg/dl) 2.16 1.10 – 4.24 < 0.001

Leukocytosis ( WC ≥

9000)

1.78 1.01 – 3.14 0.004

Fever (T ≥ 37°C) 1.55 1.01 – 2.80 0.041

When reimplantation is safe ?

• Studies indicate that up to 30% of patients may no longer

require a cardiac device. 1,2

1-J Am Coll Cardiol 2007; 49:1851–1859

2-J Am Coll Cardiol 2007; 49:1851–1859..

• Presence positive pre / post operative blood cultures

• Presence of valvular- or lead-associated vegetations

• Positive lead-tip cultures or preoperative sepsis

• PCR –ESV Procalcitonine resolution of fever, normal white

blood cell count

• PM dependent ?

Class I 1. Each patient should be evaluated carefully to determine whether there is a

continued need for a new CIED. (Level of Evidence: C)

2. The replacement device implantation should not be ipsilateral to the

extraction site. Preferred alternative locations include the contralateral side, the

iliac vein, and epicardial implantation. (Level of Evidence: C) Subcut ICD

Class II a 1. When positive before extraction, blood cultures should be drawn after device

removal and should be negative for at least 72 hours before new device

placement is performed.(Level of Evidence: C)

2. New transvenous lead placement should be delayed for at least 14 days after

CIED system removal when there is evidence of valvular infection. (Level of

Evidence: C)

Recommendations for New CIED Implantation After Removal of

an Infected CIED

Circulation. 2010;121:458-477 Baddour et al

Site of reimplantation

Ipsilateral (malfunction –venous occlusion)

Contralateral

Epicardial (5%)

Trans-femoral

Types of Leads

Active fissation

Passive fissation

Single or double coil

Diagnostic Flow-chart – 3 Reimplant of the system

Device to reimplant

Blood cultures negative

Echo TE positive

Blood cultures positive

Echo TE negative

Pocket infection

Exposition of a part of the system

Repeat blood cultures post extraction

Repeat blood cultures post extraction

Blood cultures negative 72h post hospitalization

Valvular vegetation

Lead vegetation

Reimplant after 14 days of first

negative blood cultures

Reimplant after blood

cultures negative for at least 72 h Reimplant after proper healing of the skin

Dababneh AS, Sohail MR; Clev Clin J Med 2011

Reimplant after blood

cultures negative for at least 72 h

Population study, from lead extraction to reimplantation.

Zucchelli G et al. Europace 2012;14:515-521

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author

2011. For permissions please email: journals.permissions@oup.com

Conclusions The complete removal of the system is the more effective

therapy for the eradication of complications divice-related

(infections, malfunctioning).

Different endovascular approches are available for leads

extraction, and the possibility of combinated use makes

the therapy more effective and safety.

To reduces complications and increase efficiency has a

key role the training and subsequent experience of the

operator

Today there are reliable data on the timing to replant