CIED Infection What to Know and How to Save Lives - Philips

CIED Infection What to Know and How to Save Lives

Grand Rounds Presentation

©2020 Koninklijke Philips N.V. All rights reserved. Approved for external distribution. D058999-00 122020

Agenda

Agenda

1. CIED infection is common

2. HRS Class I guidelines for referral & removal

3. Patient outcomes

4. Antibiotics vs efficacy & safety of complete removal

5. How we can work together to improve patient care


Infection is common in device patients1

N=72,701 PM Implants

Over 3 years, 1 in 20 patients develops PM infection*

*Most infections are not directly related to the care received while in a hospital20

60,000+ patients develop an infection annually37

– Pocket infection

– Systemic infection

– Endocarditis

>65% of patients are under treated4

– >6 in 10 patients suffering from cardiac device infections are treated with antibiotics only or not treated at all


Infection risk increases over time2

Overall Rate of CIED Infection:

• 6.2% at 15 years

• 11.7% at 25 years

• 24.1% with 3+ pocket manipulations [i.e. implant, pocket

manipulation 2, pocket manipulation 3]


HRS Class I Indication for Referral & Removal3

Extractor Consultation

• Evaluation by physicians with specific expertise in CIED infection and lead extraction is recommended for patients with documented CIED infection. (Class I

indication)

Extraction

• Class I indication to remove all hardware for systemic infection, pocket infection, or endocarditis. (Class I indication)

Antibiotics

• If antibiotics are going to be prescribed, drawing at least two sets of blood cultures before starting antibiotic therapy is recommended for all patients with

suspected CIED infection to improve the precision and minimize the duration of antibiotic therapy. (Class I indication)

Despite Class I guidelines for device removal, 65% of patients with CIED infection may be under-treated (do not undergo complete device removal) and are at risk for recurring infection, endocarditis or death.4


Patient outcomes

“Delaying the definitive operation with removal of all of the components of the CIED system can be a fatal choice for the patient.” – HRS Consensus

0.28%

26-35%

66%

Procedural mortality from

extraction5

1-year mortality rate with CIED

infection6,7

Mortality from device-related endocarditis5

Antibiotics only Extraction

Reported mortality

47.6% bacteremia8* 16.7% bacteremia8*

Up to 66% endocarditis9** 18% endocarditis9**

Relapse rate9-13

50–100% 0-4.2%

Procedure risk14

0.28% mortality

1.4% major adverse event rate

97.7% clinical success rate*12-week mortality**Mean follow-up period 22 ± 4 months


One-year survival device removal vs no removal during index hospitalization15

Δ 18.2%


High Risk of Relapse Without Complete System Removal

0.9% 1.0% 1.1% 0%4.2%

50% 50%

60%67%

100%

Chua, J.D. (2000) Klug, D. (2004) Sohail, M.R. (2007) Margery, R. (2009) Del Rio, A. (2003)

Relapse Rates by Treatment9-13

Complete System Removal

Partial System Removal or Medical Treatment Alone

n=123Cardiac device

infection patients

n=105Patients with local

pocket symptoms or overt infections

n=185Cardiac device

infection patients

n=39Cardiac device

infection patients

n=31Device related endocarditis

patients

7XMortality

In multivariate analysis, conservative management was associated with a 7-fold increase in 30-day mortality16

A multicenter prospective study found an 80% failure rate within 6 months for attempting to salvage infected CIEDs17

80%Failure within

6 months17


Timely referral can be life-saving18

N = 127 N = 106

“Delayed infected CIED extraction is associated with worse in-hospital morbidity and 1-year mortality. This underscores the importance of early detection and a strategy for prompt management including lead extraction.”18

Immediate system removal is associated with a 3-fold decrease in one-year mortality as compared to preliminary antibiotic treatment and delayed system removal16

3XMortality


>65% of Patients Not Treated with Class I Guidelines, Why?Identification

–41% of device infected

patients have an

endovascular infection, and

their pockets may look

intact (image on right)19

–Many systemic infections

have a source other than

the device.20

Timing

–Most device infections

occur >1 year after pocket

manipulation.20

41%

59%Pocket Infection

Endovascular Infection16

(intact pocket)*

*A device pocket that appeared benign but who had systemic signs and symptoms of infection and a clinical history, supported by microbiology and occasionally echocardiographic imaging data that guided the treating team to the diagnosis of device-related infection

Breakout of Infection: Pocket vs. Endovascular19

https://www.eplabdigest.com/articles/Axial-Access-and-Lateral-Pocket-Technique-Antiarrhythmic-Device-Placement


https://www.eplabdigest.com/articles/Axial-Access-and-Lateral-Pocket-Technique-Antiarrhythmic-Device-Placement

Case Example – Yale38

– Patient with ICD presented with pocket infection in 2009. Blood cultures were

positive for coagulase negative Staphylococcus.

– Generator removed, but the lead was cut and retracted back into the

subclavian vein (image on right). Treated with antibiotics & implanted with

dual-chamber ICD.

– In 2010, patient developed a lump on his neck & prescribed several courses of

antibiotics.

– From 2011-2012, patient underwent 3 surgeries for a recurrent left neck mass.

In the 3rd procedure, dissection of tract was described as originating from the

left subclavian.

– After several physician evaluations & 12 positive blood cultures, he was finally

referred to an EP extractor, his lead was extracted, and his infection cured.

“Four years after the initial infection, having undergone three ENT surgeries, numerous evaluations by different specialists and 12 positive blood cultures with the same organism, he underwent extraction of both the abandoned lead and the dual chamber ICD, which cured his infection.”

–Jude Clancy, MD

“If patients are being missed at a well-resourced major medical institution, I believe they are probably being missed at other institutions as well.”

-Jude Clancy, MD


4-5%

3.8%

2.2%

1.4%

1.0%

0.4%

1-2%

3.5%

0.0%0.3% 0.2% 0.1%

PCIs TAVR Leadaddition/revision

Leadremoval

(LExICon)

A-Fibablation

DFT

Procedural Major Adverse Event

Procedural Mortality

Perceived vs Actual Procedural Risk: Comparison of Lead Extraction vs Other Common Procedures21-31

1.1%*

97.7%Clinical Success32

Proven safety of lead extraction

99.7%Procedural safety rate32

88.2%SVC tear survival with proper use of Bridge occlusion balloon33

* 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 werebleeding requiring transfusion which is no longer defined as an MAE by the 2009 HRS Expert Consensus Document.


Together, we can save lives. Here’s what we can do3:

13

Diagnosis*

- Blood cultures- Imaging (TEE)- Check pocket (erosion, redness, etc)- 2 sets of blood cultures before antibiotics

Referral (Class I)**

- Positive blood culture

- Positive TEE (vegetation)

- Evidence of pocket infection/erosion (see next slide)

Patient Education

- HRS patient education website + educational brochures:

upbeat.org/cied-management

*See HRS diagnosis charts in back-up slides for more information

**The presence of any one of these (individually) triggers a referral


Examples of Pocket Infection

14

Less obvious

More obvious

Images courtesy of

Bruce Wilkoff, MD


A life-saving equation3


16

Additional Information


Disciplines to consider including in Grand Rounds, CEUs, or other education with this information

17

❑ Electrophysiologists

❑ Cardiac surgeons

❑ Infectious disease

❑ Nephrology

❑ ER Staff

❑ Device clinic staff

❑ Primary care physicians

❑ General cardiologists

❑ Interventional cardiologists

❑ Internal Medicine


HRS Diagnosis Charts3

18

To download the full HRS Consensus Pocket Guide, click here


https://www.philips.com/c-dam/b2bhc/us/landing-pages/lead-management/consensus-pocket-guide.pdf?_ga=2.140880501.690281582.1605888210-494422228.1588196958


19





20




>6 in 10 patients not treated appropriately with complete system extraction4

21

Images from D021403-04 Infection InfoGraphic


ANTIBIOTICS ALONE MAY BE INEFFECTIVE

• Biofilms that cause antibiotic resistance are present in up to 85% of microbial infections34

• These bacterial biofilms adhere to devices and leads- this makes curing the infection difficult without complete system removal35

• Bacteria in biofilms are highly resistant to antibiotics; sometimes requiring a minimum antibiotic concentration 1000 times that of free-living bacteria34,36

Higher risk of:

✓ Infection Relapse

✓ Prolonged Antibiotic Use

✓ Antibiotic Resistance

✓ Endocarditis

✓ Mortality

Image of bacterial biofilm surface

Image courtesy of Dr. Roger Carrillo


No Predictable Factors for Salvaging an Infected Device17

• Study of 10 international academic centers who

conducted a prospective review of 433 patients in

MEDIC database

• Results - Within 6 months:

–101 / 127 attempted device salvages failed (80%)

–14 / 53 patients discharged with an infected CIED

died (26%)

• No predictors were identified for what could be

salvaged

23

“Device removal should remain a mandatory and early management intervention in patients with CIED infection.” 17

80%Device salvage failure within 6

months17


References1. Canti llon, D. J., Exner, D. V., Badie, N., Davis, K., Gu, N. Y., Nabutovsky, Y., & Doshi, R. (2017). Complications and health care costs associated with transvenous cardiac

pacemakers in a nationwide assessment. JACC: Cl inical Electrophysiology, 3(11), 1296-1305.2. Dai , Mingyan, et. al. “Trends of Cardiovascular Implantable Electronic Device Infection in 3 Decades: A Population-Based Study.” JACC: Cl inical Electrophysiology (September

2019).

3. Kusumoto et a l. 2017 HRS Expert Consensus Statement on Cardiovascular Implantable Electronic Device Lead Management and Extraction. Heart Rhythm, 20174. Sohail, M Rizwan, et al. Incidence, Treatment Intensity, and Incremental Annual Expenditures for Patients Experiencing a Cardiac Implantable Electronic Device Infection:

Evidence From a Large US Payer Database 1-Year Post Implantation. Ci rc Arrhythm Electrophysiol. 2016; 9(8).5. SohailMR, et a l. Management and outcome of permanent and implantable cardioverter-defibrillator infections. J Am Coll Cardiol. 2007;49:1851–1859.6. Maytin M, Jones SO, Epstein LM. Long-Term Mortality After Transvenous Lead Extraction. Circ Arrhythm Electrophysiol. 2012;5:252-257.7. SohailMR, Henrikson CA, Bra id-Forbes M, Forbes K, Lerner DJ, Mortality and cost associated with cardiovascular implantable electronic device infections. Arch Inern Med/Vol

171 (No. 20). Nov 14, 20118. Chamis AL., et a l. Staphylococcus aureus Bacteremia in Patients with Permanent Pacemakers or Implantable Cardioverter-Defibrillators. Ci rculation. 2001;104:1029-1033.

doi :10.1161/hc3401.095097.9. Chua, J.D., et al. (2000). Diagnosis and management of infections involving implantable electrophysiologic cardiac devices. Annals of Internal Medicine, 133(8): 604-608.10. del Rio A, Anguera I, Miro JM, et a l. Surgical treatment of pacemaker and defibrillator lead endocarditis: the impact of electrode lead extraction on outcome. Chest

2003;124:1451–9.11. Klug, D., et a l. (2004). Local symptoms at the site of pacemaker implantation indicate latent systemic infection. Heart, 90(8), 882-886.12. SohailMR, et a l. Management and outcome of permanent and implantable cardioverter-defibrillator infections. J Am Coll Cardiol. 2007;49:1851–1859.13. Margey, R. et a l. Contemporary management of and outcomes from cardiac device related infections Europace (2010) 12 (1): 64-70 fi rst published online November 11, 2009

doi :10.1093/europace/eup362 14. Wazni, O et. a l. Lead Extraction in the Contemporary Setting: The LExICon Study: A Multicenter Observational Retrospective Study of Consecutive Laser Lead Extractions, J Am

Col l Cardiol, 55:579-586.15. Athan, E., Chu, V. H., Tattevin, P., Selton-Suty, C., Jones, P., Naber, C., ... & Spelman, D. (2012). Cl inical characteristics and outcome of infective endocarditis involving

implantable cardiac devices. Jama, 307(16), 1727-1735.


References continued16. Le KY, Sohail MR, Friedman PA, et a l. Impact of timing of device removal on mortality in patients with cardiovascular implantable electrophysiologic device infections. Heart

Rhythm 2011;8:1678 – 85.17. Peacock Jr, James E., et al. “Attempted salvage of infected cardiovascular implantable electronic devices: Are there clinical factors that predict success?.” Pacing and Clinical

Electrophysiology 41.5 (2018): 524-531.

18. Lin, Andrew, et al. “Early Versus Delayed Lead Extraction in Patients with Infected Cardiovascular Implantable Electronic Device.” Moderated ePoster Presentation. 2020 Heart Rhythm Society Annual Abstract Presentations Online.

19. Tarakji, K, et a l. Cardiac implantable electronic device infections: presentation, management, and patient outcomes, Heart Rhythm, Vol. 7, No. 8, 2010: 1043-7.20. Hussein et al. Microbiology of Cardiac Implantable Electronic Device Infections. J Am Col l Cardiol EP 2016;2:498–505 Circ Arrhythm Electrophysio21. Kern M. SCAI Interventional Cardiology Board Review Book. Lippincott Williams & Wi lkins 2006; p.165.

22. Barbanti M, Petronio AS, Capodanno D, et a l. Impact of balloon post-dilation on clinical outcomes after transcatheter aortic valve replacement with the self-expanding CoreValveprosthesis. JACC Cardiovasc Interv 2014;7:1014–21. 10.1016/j.jcin.2014.03.009

23. Doshi R, Decter DH, Meraj P. Incidence of arrhythmias and impact of permanent pacemaker implantation in hospitalizations with transcatheter aortic va lve replacement. Cl inCardiol. 2018;41:640–645.

24. Cul ler, SD, Cohen, DJ, Brown, PP. Trends in aortic valve replacement procedures between 2009 and 2015: has transcatheter aortic valve replacement made a difference? Ann

Thorac Surg 2018; 105: 1137–1143.25. Poole, J. et. al., Complication Rates Associated with Pacemaker and ICD Generator Replacements when Combined with Planned Lea d Addition or Revision, American Heart

Association, November 15, 2009.26. Wazni, O et. a l. Lead Extraction in the Contemporary Setting: The LExICon Study: A Multicenter Observational Retrospective Study of Consecutive Laser Lead Extractions, J Am Col l

Cardiol, 55:579-586.

27. Elayi CS, Darrat Y, Suffredini JM, et al. Sex differences in complications of catheter ablation for atrial fibrillation: Results on 85,977 patients. J Intervent Cardiac Electrophysiol. 2018:1-7.

28. Khan MN, et a l. Pulmonary-vein isolation for atrial fibrillation in patients with HF. N Engl J Med 2008;359(17):1778–178529. Jones DG, et al. A randomized trial to assess catheter ablation versus rate control in the management of persistent atrial fi brillation in HF. J Am Col l Cardiol 2013; 61(18):1894–190330. Hummel J, et al. Phased RF ablation in persistent atrial fibrillation. Heart Rhythm 2014;11(2):202–209.31. Brignole, M. et. al., Defibrillation testing at the time of implantation of cardioverter defibrillator in the clinical practice: a nation-wide survey, Europace 2007 Vol . 9 No. 7: 540-543.32. Wazni, O et. a l. Lead Extraction in the Contemporary Setting: The LExICon Study: A Multicenter Observational Retrospective Study of Consecutive Laser Lead Extractions, J Am Col l

Cardiol, 55:579-586.33. Ryan Azarrafiy, BA; Darren C. Tsang, BS; Bruce L. Wilkoff, MD, FHRS; Roger G. Carrillo, MD, MBA, FHRS. The Endovascular Occlusion Balloon for Treatment of Superior Vena Cava

Tears During Transvenous Lead Extraction: A Multi-Year Analysis and An Update to Best Practice Protocol. Ci rculation: Arrhythmia and Electrophysiology, August 2019.


References continued34. Lazãr, Veronica, and C. Chifiriuc. "Medical significance and new therapeutical strategies for biofilm associated infections." Rom Arch Microb & Immunol 69 (2010): 125-138.35. Wilkoff, B.L., et al. (1999). Pacemaker lead extraction with the laser sheath: Results of the Pacing Lead Extraction with Exc imer Sheath (PLEXES) Trial. Journal of the American College of Cardiology, 33(6).36. Chen L. and Wen, Y. “The role of bacterial biofilm in persistent infections and control strategies.” Int J Oral Sci, 2011, DOI: 10.4248/IJOS11022 37. iData, MRG, Eucomed, EHRA White Book, Product Performance Reports (Biotronik, Boston Scientific, Medtronic, and St. Jude Medical), and internal estimates / analysis on file.38. Philips case study on file - D021414-01 Cardiac Device Infection Awareness - Clancy.pdf


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CIED Infection What to Know and How to Save Lives - Philips