Προβληµατισµοί κατά την αντικατάσταση απινιδωτή. Νέος απινιδωτής, βηµατοδότης ή τίποτα;

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1 Προβληµατισµοί κατά την αντικατάσταση απινιδωτή. Νέος απινιδωτής, βηµατοδότης ή τίποτα; Ε. Συµεωνίδου, MD, PhD Β Παν Καρδιολογική, Aττικόν Νοσοκοµείο Σεµινάρια οµάδων εργασίας EKE 2015 Iωάννινα

2 ICDs Replacement! >100,000 implantations of ICDs annually in the United States.! Of these, 25% are replacements of existing devices because of battery depletion.! Because of the high cost and concern about patient selection, the appropriateness of initial device placement has been closely scrutinized.! But there has been little consideration as to what happens in the years after implantation, when! ICD batteries require replacement, device leads become defective, or systems become infected.

3 ICD Replacement! Should all these patients routinely receive replacement ICDs?! Is it necessary to ensure that the patients continue to meet criteria for implantation at the time of device replacement?! Is it time for a Change?! Is it time for a New Approach to ICD Replacement

4 Incidence of arrhythmic events in patients with ΙCD for secondary prevention The specificity of the selection criteria for ICD low

5 Primary prevention ICD replacement/matter of debate! No doubts exist about the need to replace ICD in secondary prevention patients; however, a debate continues on how to approach subjects implanted in primary prevention referred for elective replacement due to battery depletion.! Only 20% to 30% of patients implanted for primary prevention receive appropriate ICD shocks. This means that up to 75% are not in need for ICD? therapy up to the time of replacement.! Whether these pts should need device replacement is a matter of debate.

6 Debate! Prevention of SCD by means of the ICD is considered to be a lifelong therapy.! However, it is still unresolved if patients who never experienced an appropriate ICD intervention during generator longevity really need to undergo device replacement.

7 2 reasons for restratification before ICD replacement!! 1st the clinical data for pts presenting for ICD replacement must be thoroughly reevaluated.! During an average of 5 years with an ICD, patients health may have evolved in ways that should influence decisions about replacement! 2nd, patients experiences living with their devices may influence their views on replacement.! Pts approach initial ICD implantation with highly variable understanding and expectations about living with a device.! Yet many Pts will have complications of device herapy, including inappropriate shocks, and ICD replacement itself exposes patients to a 5% risk of major complications.

8 Refraining from replacing an ICD. Apart from Clinical problem an ethical! Previously recommended ICD as a lifesaving therapy. Now no longer required and neglecting replacement?! Refraining from replacing an ICD may be viewed in the same light as deactivating a currently functioning one.! Similar to primary implantation, replacement of a generator should involve conscious participation by the patient and should be preceded by a clear presentation of all benefits and risks related to a procedure

9 Absence of guidance at the time of battery depletion! Lack of empirical data on outcomes after ICD replacement has prevented the development of evidence-based recommendations to guide clinicians.! In the absence of such guidance, clinicians may feel compelled by ethical or legal considerations to replace the ICD regardless of whether the patient still meets implantation criteria.

10 At the time of generator replacement physicians have to ICD replacement candidates!as evidenced by randomized trials and ICD registries, only 20% to 30% of patients implanted for primary prevention receive appropriate ICD shocks. Never appropriate shock EF 35% Never appropriate shock But improvement of EF 35%

11 What to do about primary-prevention ICDs in pts with improved EF! 20-40% of HF pts with reduced EF demonstrate substantial improvement in their EF during FU.! When they present for elective replacement of ICD should ICD be continued? Naksuk N, Adabag S. Curr Heart Fail Rep 2014

12 Incidence of appropriate shock in ICD with Improved EF At generator replacement 27% EF<35% 36% Improved EF >35% 26% unchanged had appropriate shocks. Some before, some after replacement, some before & after On the basis of these observations, the authors conclude that some ICD patients whose LVEF improves to >35% at generator replacement remain at risk of appropriate ICD shocks Naksuk N, Saab A, Li JM, et al. Incidence of appropriate shock in implantable cardioverter-defibrillator patients with improved ejection fraction. J Card Fail 2013;19:

13 In patients who at the time of ICD present with LVEF above ICD indications limits, 3 potential clinical situations should be considered:! a) unrecognized reversible cause of left ventricular dysfunction at the time of implantation;! b) spontaneous positive remodeling occurred, and! c) might have had inappropriately assessed LVEF at the time of implantation and in fact has never fulfilled the implantation criteria.! Recent data from the MADIT-CRT trial showed that 38% of patients enrolled in a trial based on the criterion of LVEF < 30% had significantly higher ejection fraction values (in the range of 30.1%-45.3%) when echocardiographic data was analyzed centrally by echo experts.

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15 DEFINITE Trial in non-ischemic cardiomyopathy Highlights that appropriate caution should be exercised to not extrapolate the positive effect of improved LVEF to the elimination of arrhythmic events! The authors concluded that LVEF improvement was associated with improved survival, but not with a significant decrease in appropriate shocks Schliamser JE, Kadish AH, Subacius H, et al., for the DEFINITE Investigators. Significance of follow-up left ventricular ejection fraction measurements in the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation Trial (DEFINITE). Heart Rhythm 2013;

16 Scar or low EF more arrhythmogenic?! It is more likely that the presence of scar and fibrosis is more arrhythmogenic than low LVEF itself, as documented by several MRI studies.! It also should be noted that autonomic nervous system changes may play a role in arrhythmogenesis

17 Time dependence of appropriate ICD therapy in ischemic cardiomyopathy K,!EF may improve but the scar still exists! The risk may be lower but not zero! [J Am Coll Cardiol. 2014]! Risk of 1st appropriate ICD therapy persists over time, and thus replacement of ICDs appears to be indicated for all patients Alsheikh-Ali AA, Homer M, Maddukuri PV, Kalsmith B, Estes NA 3rd, Link MS. Time-dependence of appropriate implantable defibrillator therapy in patients with ischemic cardiomyopathy. J Cardiovasc Electrophysiol 2008;19:784 9.

18 NICMP Evaluation of the Need of Elective ICD Replacement in Primary Prevention Patients Without Prior Appropriate ICD Therapy! A substantial number of primary prevention patients without previous appropriate ICD therapy received appropriate ICD therapy after first device replacement.! However, non-ischemic cardiomyopathy patients represent a low arrhythmic subgroup and the benefit of elective ICD replacement seems less clear in this population. In NICMP patients using beta-blockers, the cumulative event rate for appropriate ICD therapy after device replacement was 4.1% at 3 years

19 INSURE trial Long-term benefit of implantable cardioverter/ defibrillator therapy after elective device replacement: results of the INcidence free SUrvival after ICD REplacement (INSURE) trial a prospective multicentre study

20 Subsequent ICD Therapies After Elective Generator Replacement Patients with no ICD indication at the time of generator replacement subsequently receive significantly fewer ICD therapies compared with patients with an ICD indication (2.8% vs. 10.7% per person-year, p < 0.001). Data do support the case to perform ICD explants instead of ICD replacement in patients with no appropriate therapies and significant improvement of the EF. Vinay Kini, MD,* Mohamad Khaled Soufi, MD,y Rajat Deo, MD, MTR,* Andrew E. Epstein, MD,*Rupa Bala, MD,* Michael Riley, MD, PHD,* Peter W. Groeneveld, MD, MS,z Alaa Shalaby, MD,Sanjay Dixit.

21 Reevaluation more complicated in CRT pts Association Between LVEF CRT Defibrillator Therapy for Sustained Ventricular Tachyarrhythmias In pts with primary prevention indications for CRTD, the estimated 2 year risk of appropriate therapy was 3.3%, 2.5%, 1.9% for those in whom post CRT LVEF increased to 45%, 50%, 55%. Manfredi et al Therefore CRT super responders have low risk of need for ICD

22 The REPLACE Death After Replacement Evaluation Score for Predicting Mortality After Device Replacement or Upgrade Should All Implantable Devices Be Replaced?! They have developed a mortality risk score, the REPLACE DARE Score, for identifying patients with limited expected longevity before the replacement, in whom the relative risk and benefit of the procedure should be carefully considered. Severe HF, arrhythmia and antiarrhythmic therapy, cerebrovascular disease, and chronic kidney disease are associated with higher mortality rates, in the general population and in specific subgroups M. Chung et al. 2014

23 Recommendations for improving decisions surrounding ICD! 1. A comprehensive medical evaluation should occur before ICD replacement,! 2. Patient preferences, past experiences, and advance care planning should be explicitly included in decision making.! 3. Advance care planning should be revisited and patients should be educated about the possibility of device deactivation at the time of potential ICD replacement.! 4. A multidisciplinary task force should be created to establish guidelines regarding the clinical, ethical, and logistic aspects of ICD replacement.! 5. Prospective studies should be conducted of patients at high or low risk for SCD who are eligible for ICD replacement to identify populations that are unlikely to benefit from therapy. N engl j med 366;4, 2012 Daniel B. Kramer, M.D., Alfred E. Buxton, M.D., and Peter J. Zimetbaum, M.D.

24 In the meantime, it is time for a new approach to elective replacements of ICDs.! 1.If LVEF improves at the time of reevaluation such that a patient no longer meets implantation criteria and! 2.has not had appropriate therapy, it is reasonable to have a discussion with the patient regarding the risk of replacement and uncertain benefit.! Finally, careful reassessment of the patient s desire for life sustaining therapies should be undertaken with a informed discussion. of their cardiac and general medical status, quality of life, and life expectancy.! From a societal perspective, this approach should result in savings.