icd replacement-what to do with devices which were never ... · icd replacement-what to do with...

ICD Replacement-What to do with devices which were never

activatedRadu CIUDIN MD, PhD, DAS-CAM (Maastricht), FESC

“C.Davila” University of Medicine and Pharmacy

Bucharest, ROMANIA

ARRHYTHMIAS UPDATE 2019

5-6 April, TESSALONIKI

How to decide what to do with ICDs/CRT-Ds witch were never

been activated (YET?)

Radu CIUDIN

ICD is a well establish therapy for SCD preventionGuidelines are not covering ICD/CRT-D Replacement issue

ICDs/CRT-Ds Replacement decision-few Questions

• Deciding the ICD/CRT-D replacement : to take it for granted or taking a new implant decision?

• Replacements do have complications!

• Not all pts with ICDs/CRT-Ds are the same !

• Re-testing the patients for ICD replacement indications : a need or present guidelines limitations ?

• New tests : fibrosis assessment? Invasive/Non-invasive EP and vest mapping? Genetic testing ?

• Psychological impact of ICD/CRT-Ds implant/replacement and ethical considerations

• A case study

Deciding ICD/CRT-D Replacement – to take it for granted or taking a new implant decision algorithm ?

ICDs/CRT-Ds Replacement decision







• A case study

Replacement complications !

More complications during Replacement !! !!

HA! Old device implanted but not the new one!

Complications are more frequent with the numberOf leads!

>10% of LV leadsAre not implanted

__________________________________

More complications – Shall we do defibrillation test during Replacement??

Do NOT forget INFECTIONS -Infection Microbiology*

•Positive Blood cultures. (41,6 %) , Stafilococus aureus 70,2%

* Ciudin R.et al. Therapeutics, Pharmacology and Clinical Toxicology , 2008

Stafilococ alb

(1)

Pseudomona

s A. (1)

Piocianic. (1)

MRSA. (3) Enterococ. (1)

Stafilococ

auriu Co-P. (2)

Stafilococ

auriu Co-N. (6)








• A case study

45%

34% 7%

6% 4%

2%

2%

8%

Indication for implantationIschemic DCM

Nonischemic DCM

HCM

ARVD

LQTS

Brugada Syndrome

Idiopatic VF

Cardiac Prognosis in ICD Replacement PtsInstitute of Cardiovascular Diseases , Bucharest, Romania

Gender – M vs F ( ? Bias?) – Co-Morbidities?

77.35%

22.65%

0.00%

20.00%

40.00%

60.00%

80.00%

100.00%

120.00%

Sex distribution

Men Women

TO ADD “SEATTLE HEART FAILURE SCORE?

Co- Morbidities!Average Age for Replacement >70 y o !

NYHA class

6%

56%

36%

2%NYHA class

NYHA I

NYHA II

NYHA III

NYHA IV

LVEF ?

45%

27%

28%

LVEF distribution

≤35% (Severe)

36-50%(mild/moderate)

>50%(preserved/normal)

Primary vs Secondary Prevention of SCD

13

40

Type of prevention

Primary prevention Secondary prevention

AIM: beneficial effects of ICDs in primary and secondary preventionConclusions : Comparable mortality between both groups. Primary prevention group = lower risk for appropriate shoks

Pre DANISH

AIM: ICD efficacy in pts without IHD : meta - analysis

ALSO POST DANISH

European Heart Journal, Volume 38, Issue 22, 7 June 2017, Pages 1738–1746, https://doi.org/10.1093/eurheartj/ehx028

The content of this slide may be subject to copyright: please see the slide notes for details.

Figure 1 Study flow chart.



Figure 4 Left ventricular dysfunction with acute myocardial

infarction: impact of primary prevention ICD on all-cause

mortality...

NO ICD indication in ACUTE MI



Figure 3 (A) Title: Left ventricular dysfunction with ischaemic

heart disease: impact of primary prevention ICD on all cause

mortality ...



Figure 2 Title: Left ventricular dysfunction without ischaemic

heart disease: impact of primary prevention ICD on all cause

mortality...

Conclusions: It may be no longer be necessary to distinguish between

ischemic vs non-ischemic when deciding on primary prevention ICD implantation. DANISH is consistent with these data . 24% reduction mortality in both aetiologies !!






• New tests : fibrosis assessment? Non-invasive EP mapping? Genetic testing ?


• A case study

JACC : Cardiovascular ImagingAugust 2017DOI:10.1016/j.jcmg.2017.04.021

• Scar Characterization to Predict Life-Threatening

Arrhythmic Events and Sudden Death in Patients

With Cardiac Resynchronization Therapy

The GAUDI-CRT Study

Juan Acosta, …, Lluis Mont and Antonio Berruezo

Juan Acosta et al. JIMG 2017;j.jcmg.2017.04.021

2017 American College of Cardiology Foundation





The GAUDI-CRT Study

AIM: to analyse whether scar characterization could improve the risk stratification for life-threatening ventricular arrhythmias and sudden cardiac death

Methods: Primary prevention class I for CRT ( D vs P) and IRM to analyse scar presence/absence ,quantity of amount of core and border zone (BZ) and distribution.

Primary endpoint: appropriate defibrillator therapy and SCD

Juan Acosta et al. JIMG 2017;j.jcmg.2017.04.021

2017 American College of Cardiology Foundation





The GAUDI-CRT Study

Results : 217 pts, (40% ischaemic), 36 months F-up, 25 pts (11,5%0 had end-point – all in pts with scar. Independent predictors: scar mass, scar heterogeneity, BZ mass and channel mass

Conclusions: The presence, extension, heterogeneity and qualitative distribution of BZ tissue of myocardial scar predict appropriate ICD therapy and SCD in CRT candidates.

Primary Prevention of Sudden Cardiac Death in a Nonischemic Dilated Cardiomyopathy Population, Volume: 6, Issue: 3, Pages: 504-512, DOI: (10.1161/CIRCEP.113.000216)

IDCM – PVS protocol for Primary Prevention of SCD


LVEF remains a significant factor to predict death but of any cause


PVS was the single independent risk factor for future ICD activation

Induction of VT/VF during PVS in pts with IDCM is associated with >1 ICD therapy

Programmed Ventricular Stimulation






• New tests : fibrosis assessment? Non-invasive EP mapping? Genetic testing ?


• A case study

Psychological Profile of ICD patient

Multifactorial:

• Depends of age, co-morbidities, social environment, culture and tradition, health system and family support…

• Anxiety

• Hope

• Sensitivity

• Withdrawal

• Uncertainty

• …

“Prof C C Iliescu Institute of Cardiovascular DiseasesC Davila Univ of MedicineBucharestRomania

Psychological ProfileOf ICD patient

90 pts3 groups :Standard, PM, ICD

California Psychological Inventory 260

27 psychological determinants

Graphic analysis of the 3 groups : PM, ICD and Standard

CPI 260 – ICD group vs Standard

ICD STANDARD

ICD pts– psychological characteristics in Romania

• All psychological characteristics are diminished ( withdrawal)

• Sensitivity enhanced

• Hostility (including against medical personnel - increased !!} –

a specific characteristic of Romanian population in a post communist transition social period)

A different issue – ICD deactivation in pts with end stage heart failure

A case study

• 19 y old young adult

• 2 fast sustained VT –presyncope/syncope

• ICD –VR implant

• No shocks/no ATP for 7/8 years. Now- Engineer at the age of 27 y o

• Battery voltage - ERI

• Coming for ICD Replacement- Has his own story – job proposal in a nuclear plant – he will lose the job if administration will find out that he has an ICD! He has family – can not afford to lose job! He want ICD explant but no replacement.

• What will you do?

Conclusions

• ICD therapy is a well establish therapy for life threatening ventricular arrhythmias and Sudden cardiac death prevention

• Thought ICDs are lifesaving for most of the patients having present guidelines indications – evaluation of clinical and ethical aspects of ICD/CRT-Ds Replacement is long overdue!

• Clinicians and Patients must move beyond the view of ICD therapy as a lifelong treatment committing patients to obtaining replacement devices for years or decades after implantation with no reassessment of a new up dated indication and re-evaluation!

Thank you !EFCHARISTO !

[email protected]

• Metoda

• CPI 260 ( California Psychological Inventory)-:• Dominanta Impresie buna

• Capacitatea de Statut Comunalitate

• Sociabilitate Stare de bine

• Prezenta sociala Toleranta

• Acceptare de sine Realizare prin Conformism

• Independenta Realizare prin Independenta

• Empatie Eficienta

• Responsabilitate Fluenta conceptuala, Intuitie psihologica

• Conformism Social Flexibilitate, Sensibilitate

• Autocontrol Potential managerial,Creativitate, leadership,amicalitate,aplicarea legii,ostilitate

Studiu –Profilul Psihopatologic al PTS cu ICD/PM-InstitutulCC Iliescu

Tip ICD (uni/bi/tricameral)

33

8

12

0

5

10

15

20

25

30

35

Unicameral Bicameral Tricameral

Defibrillator type

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