Device Complications: Infection and Safety

Extract All Hardware

1

Angelo Auricchio, MD PhD FESC

Director, Cardiac Electrophysiology Programme, Fondazione Cardiocentro Ticino, Lugano

Director, Center for Computational Medicine in Cardiology, Università della Svizzera Italiana, Lugano

Scientific Director, Fondazione Ticino Cuore, Lugano

Professor of Cardiology, University of Magdeburg, Germany

Past-President European Heart Rhythm Association

Disclosure:

Consultant to Abbott, Biosense Webster, Bristol-Myers Squibb, Boston

Scientific, Cardiotek-Schwarzer, Cordis Biologics Delivery Systems, DC

Devices, Leadexx, Medtronic Inc, Resmed, Respicardia, Schiller AG,

LivaNova

Speaker fee from Boston Scientific, Medtronic Inc, Resmed, Respicardia,

LivaNova

Rates of mortality and nonfatal outcomes

after ICD implantation

2 Ranasinghe et al Ann Inter Medicine 2016

• 114’484 patients aged 65 years or older (mean: 74.8) first ICD implantation

• 72.4% male

• 1437 US hospitals

ELECTRa: Indications

N=3,555 patients

Bongiorni MG et al. ESC Late Breaking Trial 2015

Changing relative indication for lead extraction over 7

years at a tertiary referral center

4 Jones SO, Heart Rhythm 2008:5;520-525,

Prevalence of CIED infection in 48 European

centres

5 Bongiorni MG et al. Europace 2012

Early versus late appearance of CIED infection:

presenting symptoms and co-morbidities

Greensporn AJ et al. JACC 2013

Difficulty

to diagnose

late

infection

Pathways to systemic infection

POCKET LEAD Pocket infections can spread to the

bloodstream and/or escalate to endocarditis

ELSEWHERE IN THE BODY BLOODSTREAM LEAD

CIED systems can be infected by bloodbornepathogens from anywhere in the body

Infection could originate from

a dental procedure

1

Or, from a leg wound that

just won’t heal

2

Or from any other infection

in the body

3

CAUTION:

Leads are a highway to the heart

fast lane for infection.

Stepwise approach to management of

suspected CIED infection in adults

Sohail M et al JACC 2007

Indication for transvenous lead extraction:

Infection

9

Class I

1. Complete device and lead removal is recommended in all patients with definite CIED system infection,

as evidenced by valvular endocarditis, lead endocarditis or sepsis. (Level of evidence: B)

2. Complete device and lead removal is recommended in all patients with CIED pocket infection as

evidenced by pocket abscess, device erosion, skin adherence, or chronic draining sinus without clinically

evident involvement of the transvenous portion of the lead system. (Level of evidence: B)

3. Complete device and lead removal is recommended in all patients with valvular endocarditis without

definite involvement of the lead(s) and/or device. (Level of evidence: B)

4. Complete device and lead removal is recommended in patients with occult gram-positive bacteremia

(not contaminant). (Level of evidence: B)

Class IIa

1. Complete device and lead removal is reasonable in patients with persistent occult gram-negative

bacteremia. (Level of evidence: B)

Class III

1. CIED removal is not indicated for a superficial or incisional infection without involvement of the device

and/or leads (Level of evidence: C)

2. CIED removal is not indicated to treat chronic bacteremia due to a source other than the CIED, when

long-term suppressive antibiotics are required. (Level of evidence: C)

Wilkoff B et al. Heart Rhythm 2009

Percentage of centres attributing class of

indication for complete hardware removal

10 Bongiorni MG et al. Europace 2012

Outcome of surgical conservative treatment

11

Results from surgical conservative treatment and antibiotics in the absence of

hardware removal have been very disappointing

38 pts with local infection

Antibiotics,

no removal

12 pts

Failure 100%

Removal +

2w AbTh

19 pts

Success 100%

Removal +

6w AbTh

7 pts

Success 100%

Del Rio et al. Chest 2003

Complete extraction reduces risk of

reinfection by 75%

Tisher et al. Europace 2014

Relapse rate by treatment in different

patients categories

13

50% 50%

60%

67%

100%

0.90% 1% 1.10% 0%4.20%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Cardiac DeviceInfection Patients

(n=123)

Patients with LocalPocket Symptoms or

Overt Infections(n=105)

Cardiac DeviceInfection Patients

(n=185)

Cardiac DeviceInfection Patients

(n=39)

Device-RelatedEndocarditis Patients

(n=31)

Partial system removal or medical Rx Complete device removal

Chau JD et al

(2000)

Klug D et al

(2004)

Sohail MR et al

(2007)

Margery R et al

(2009)

Rio A et al

(2003)

Mechanism of biofilms formation and

protection from immune response

14

Contact with solid surface triggers the expression of a panel of bacterial enzymes which catalyze the formation of sticky polysaccharides that promote colonization and protection.

Bacteria embedded within biofilm are resistant to both immunological and non-specific defense mechanisms of the body.

Antibodies, topical and systemic antibiotics are unable to penetrate the biofilm which also acts as a microbial reservoir for infection of neighboring tissue

Risk of delayed system removal

15

“Delaying the definitive operation

with removal of all of the

components of the CIED system

can be a fatal choice for the patient”

Wilkoff B et al. Heart Rhythm 2009

• Antibiotic therapy without device removal is associated with a 7-fold increase in 30-day mortality

• Immediate system removal is associated with a 3-fold decrease in 1-year mortality as compared to preliminary antibiotic treatment and delayed system removal

• Mortality rates in patients with endocarditis who had systems removed are less than 18%, compared with up to 66% with antibiotics alone.

New scenario in lead extraction

16

In the past Cardiac surgery

Restricted indication (septicemia)

High morbidity

High mortality

More recently Extraction equipment is more complete, sophisticated and

efficient

Technique have improved

Physicians are more skilled

Risk and morbidity of the procedure, when performed by experienced physicians are low

17

Vegetation size and lead-associated

endocarditis

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Vegetation Size <10 mm

(n=61)

Vegetation Size >10 mm

(n=68)

CIED removal 100% 96%

Removal at time initial presentation 60.6% 80.6%

Laser sheath 62.2% 49%

Major procedure related complications

- Open thoracotomy/sternotomy

- Percutaneous removal

1 pt (1.7%)

- Respiratory failure

7 pts (10.2%)

- Respiratory failure (1), remote infection (1)

- Vascular tear (2), stroke (1), pulmonary

embolism (4)

Vegetation Size

(<10 mm)

Vegetation Size

(>10 mm)

Greensporn AJ et al JACC Card Imag 2014

Survival of patients with CRT after device

infection, extraction and reimplantation

19 Rickard J et al JACC HF 2013

Survival of patients with CRT after device

infection, extraction and reimplantation

20 Rickard J et al JACC HF 2013

Complication incidence is decreasing

Laser-assisted removal

Year

PLEXES

153 pts

9 centers

1999

Total US

1684 pts

89 centers

2002

LExICon

1449 pts

13 centers

2009

Procedural MAEs 2.0% 1.9% 1.4%

Procedural Mortality 0.65% 0.6% 0.28%

% MAE Patients Surviving 67% 69% 80%

Clinical trials have demonstrated that the overall rate of

complications associated with lead extraction procedures is low

and decreasing

Complications do not have to be fatal if proper procedural

precautions are instituted and followed

Lesson from the ELECTRA Registry

High Volume Centre > 2.5 pts/month

Low volume Centre ≤ 2.5 pts/month

High Volume Centre > 2.5 pts/month

Low volume Centre ≤ 2.5 pts/month

N=3,510 patients

Bongiorni MG et al. HRS 2016

The LExICon study reports a procedural MAE rate of 1.4%, as defined by the 2000 NASPE Policy Statement. However, 0.3% (n=4) of the MAEs were bleeding requiring transfusion,

which is no longer defined as an MAE by the 2009 HRS Expert Consensus Document

0%

1%

2%

3%

4%

5%

6%

A-Fib Ablation DFT

5.9%

0.08-

0.23%

PCIs

4-5%

1-2%

0.4%

Procedural MAEs

Procedural Mortality

0.07%

Lead Removal

(LExICon)

1.4%

0.28%

2.2%

Lead

Addition/Revision

1.1%

Comparative complications rate

How to make safe an extraction procedure ?

24

Facilities- High quality fluoroscopy

Extraction team

Equipment- Emergency sternotomy & ECC

Protocols

Volume & Experience

Specific Set-Up & Team Comprehensive Toolkit

25

Average cost of a hospital-acquired infection

USD 72’000

Cost to healthcare system

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Enormous economic burden on hospitals and the healthcare system

Early removal reduces length of hospital stay and increases survival

Timing of Lead Removal

<10 days >10 days

Length of Hospital Stay 18 ± 13 44 ± 38

Survival (at one year) 83.1% 66.1%

USD 56’470 potential cost of

delayed treatment

Greensporn AJ et al. JACC 2011

ELECTRa: Follow-up 12 MonthsMortality by infective complications

N=3044 patients

P < 0.0001

Preliminary

analysis

Preliminary

analysis

5.4%10.2%

66.7%

6.5%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Patients uninfected atFollow Up

Patients localyinfected at Follow Up

Patients systemicinfected at Follow Up

All patients

Follow Up 1 YearMortality by infective complications

at Follow Up (%)

P < 0.0001

P < 0.0001

Courtesy by Bongiorni MG (ELECTRA Registry)

Algorithm of managing a patient with

infected CIED

28 Nof E and Epstein LM. Eur Heart J 2013

Conclusion

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No attempt should be made to save an infected

system from removal because

it endangers the patient’s life,

prolongs hospitalization,

increases costs, and

most likely will fail !

Thank you for your attention

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Lugano, Switzerland