Le complicanze nei portatori di ICD e CRT
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1 Le complicanze nei portatori di ICD e CRT Attilio Del Rosso Key points: 1 ICD therapy has been shown to be effective in aborting sudden arrhtymic death and reducing mortality 2 Patients who do not benefit from device therapy are exposed to procedural and device complications 3 Needs in the future for greater reliability fo devices
2 Effect of implantable cardioverter defibrillator (ICDs) on all-cause mortality in randomized trials
3 NNT to save one life for ICDs and various cardiovascular drugs
4 ICD Evolution Worldwide
5 Impianti di defibrillatori e defibrillatori per CRT in Italia (EUCOMED) ICD CRT-D Tot
6
7 aa,, miocardiopatia ipertrofica non ostruttiva, non familiarità per morte improvvisa - Una sincope nel passaggio dalla posizione accovacciata ad eretta - Impianto AICD sottopettorale Dopo 6 mesi dislocazione del generatore in sede ascellare - Reimpianto di nuovo dispositivo in sede sottopettorale - In 4 anni nessun intervento del dispositivo per TV
8 Peri-implantation complications (Ezekowitz 2007) Complications Type of study Studies n Raw data Pooled risk RCT (LVSD) 8 35/ Death RCT (no LVSD) Observational (LVSD) /725 24/ Observational (no LVSD) 6 454/ Total / Mechanical RCT Observational / / Total /
9 Italian DT survey (7857 procedures) Intraoperative complications Total % Death % Cardiopulmonary arrest % Cardiogenic shock % Stroke % Pulmonary embolism % External DC shock % (high threshold) System revisions %
10 Post-implantation complications 1. (Ezekowitz 2007) Complications Type of study Studies n Leads problems RCT Observational Total Raw data 11/ / /6955 Pooled risk* Inappropriate RCT 2 155/ shocks Observational Total / / Infections RCT Observational / / Total 17 76/ * Per 100 patients-years
11
12 Implanted Transvenous Right Ventricular Lead models and Number of Defective Leads (Kleeman 2007) 148/990 (15%) - FUP 1525 days
13 Kaplan-Meier curves of event-free lead function of the Medtronic lead models 6936 and 6966 (n234) compared with a pooled group of models that were implanted from 1997 onwards (n746).
14 Medtronic Sprint Fidelis elettrocateteri impiantati nel mondo But in spite of such widespread use, the FDA never required the Sprint Fidelis Leads to be tested in humans 665 fratture in elettrocateteri estratti before they were marketed, and it did not monitor the 5 decessi verosimilmente attribuibili alla device after it was introduced. frattura 2,3% In di una fratture più recente entro 30 stima mesi il dall impianto tasso di malfunzionamento è del 3,75%/anno e del 12,1% a 3 anni vs 0.58%/anno e 1,5% a 3 anni degli altri elettrocateteri
15 Lethal Proarrhythmia Tung, R. et al. J Am Coll Cardiol 2008;52:
16 Increased rate of subacute lead complications with small-caliber implantable cardioverter-defibrillator leads (Ellis 2009) Small-diameter (n= 138) Standard-diameter (n= 167) p Lead failures 11 (8%) 1 (0,6%).0008
17 Incidence of different causes of lead defects versus time after lead implantation (Kleeman 2007)
18 Annual rate of defibrillation lead defects versus time after lead implantation. (Kleeman 2007)
19 Complications in Patients with Single Chamber, Dual Chamber, and Biventricular CRT-ICDs (Alter 2005)
20 Uno shock appropriato non equivale ad uno shock necessario
21 Fattori che possono giustificare una elevata incidenza di shocks appropriati Programmazione Riconoscimento breve (12/16) Terapia attivata anche su tachicardie lente Effetto proaritmico del device
22 Factors Potentially Influencing Incidence of ICD Therapies Irritability from lead(s): suspect if events occur early after implantation Ventricular undersensing with resultant inappropriate pacing Increased fractionation of left ventricular electrograms possibly signifying effects on conduction in scar-related isthmus sites Double wave reentry: best described with acceleration of VT during anti-tachycardia pacing Right ventricular pacing: increased heart failure events may lead to more VT/VF episodes Biventricular pacing (possibly by abnormal wave fronts) may increase arrhythmias in selected patients, or decrease arrhythmias due to improved heart failure status Heterogeneity of repolarization/dispersion of refractoriness Physical damage to system
23 Clinical ventricular tachycardia Pacing at the ICD lead tip
24 Reducing cardioverter-defibrillator shock administration by Antitachycardia Pacing during Device Charging
25 Strategic Programming of Detection and Therapy Parameters in Implantable Cardioverter-Defibrillators Reduces Shocks in Primary Prevention Patients (Wilkoff 2008)
26 Patients Experiencing Inappropriate ICD Shocks in MADIT II (2008)
27 Causes of inappropriate shocks Supraventricular tachycardia (sinus tachycardia & atrial fibrilation) Oversensing T-wave, P-wave Diaphragmatic/myopotential sensing Sensing Lead problem (fracture/insulation disruption/migration) Pacemaker interaction External electrical interference (EMI) The implantable cardioverter defibrillator. E. Alt H.Klein J.C.Griffin p257
28 Rhythm Responsible for ICD Shock Episodes in MADIT II (2008)
29 Impact of Defibrillator Shocks on Quality of Life (Schron 2002) Comparison SF-36 PCS Score p Patients concerns p ICD shocks* 1.45 (-2.74, -0.18) (1.07, 3.23).001 *Any versus none
30 Dislodgement of the ventricular lead to the level of the tricuspid annulus causes fatal inappropriate ICD shock (Veltmann 2007)
31 Hazard Ratios for the Association of ICD Shock with the Risk of Death, According to Shock Type Poole J et al. N Engl J Med 2008;359: SCD-HeFT population
32 Predictors of All-Cause Mortality by Cox Proportional Hazards Regression Analysis in MADIT II (2008)
33
34 Cumulative probability of infection in patients with an implantable cardioverter-defibrillator (ICD) vs those with a permanent pacemaker (PPM) (Uslan 2007) Incidence 1.9 per 1000 device-years Device infections Blood-stream infections
35 Prevalence and risk factors related to infections of cardiac resynchronization therapy device (Romeyer-Bouchard 2009) 303 CRT devices 4,3% infections at 2,6 years Risk factors for infections: procedure time (p = 0.002) dialysis (p = ) re-intervention (p = 0.006) procedure type (CRT-ICD vs. CRT-PM or upgrading procedures; p = 0.01)
36 Post-implantation complications 2. (Ezekowitz 2007) Complications Type of study Studies n Raw data* Pooled risk Mechanical malfunction RCT Observational Total / / / Device malfunction RCT Observational / / Total / * Number of patients/patients-year
37 Pace Maker and Implantable Cardioverter- Defibrillator Malfunction Rates (Maisel 2006) Pacemaker ICD
38 Company/Device Date Advisory Issue Risk of Advisory of Failure Medtronic Marquis Guidant Ventak Prizm 2 DR Guidant Ventak Prizm AVT Vitality AVT Contak Renewal AVT Guidant Contak Renewal 3, 4 Renewal 3, 4 AVT, RF February 2005 June 2005 June 2005 June 2005 Accelerated battery depletion caused by internal battery short 0.01 Short circuit caused by wire insulation problem within lead connector block 0.1 Random memory error, limiting delivery of therapies Magnetic switch faulty, impairing delivery of therapies St Jude Photon DR Photon MicroVR/DR Atlas VR/DR October 2005 Memory chip affected by atmospheric radiation, which can impair pacing and delivery of therapies ELA Alto ICD August 2001 Migration of metal, which can impair pacing and delivery of therapies
39 Deaths associated with implantable cardioverter defibrillator failure and deactivation reported in the USA FDA MAUDE Database ( ) (Hauser 2004) Total deaths 212 Leads or pulse generators failure 103 (49 %) No informations available from the manufacturers 3 devices deactivated prior elective surgery 5 devices programmed Monitor only Deactivation of normally functioning device 51 (24%) 11 (5%) 3 devices deactivated by inadvertent exposure to electromagnetic interferences
40 Complications from 533 elective advisory device replacements during a mean of 2.7± 2.8 months of follow-up (Gould 2007) Minor Severity and complications No (%) Incisional infection, medically managed 9 (1.7) Significant site pain, medically managed 1 (0.2) Heart failure requiring admission 1 (0.2) Major psychological morbidity, medically managed 1 (0.2) Major Pocket infection requiring extraction 10 (1.9) Postextraction deaths 2 (0.4) Hematoma requiring reoperation 12 (2.3) System malfunction requiring reoperation 8 (1.5) Significant site pain requiring reoperation 1 (0.2) Total 43 (8.1)
41
42 History of pioneering ICD technology Future developments 144 cc/235 g 32 cc/82 g 1980 Future Needs 1988 in the 1997 future for 1999 greater 2004reliability of leads and devices. Testing new ICD technology! developments Breakthrough CRM solutions 1st human implant of Automatic Implantable Defibrillator (AID) ENDOTAK - 1st human implant of endocardial shocking lead Eliminated need for thoracotomy First dualchamber ICD First CRT-D in Europe First CRT-D RF device
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