Device Implantation: Long-Term Commitments. Fayez Bokhari, MD, FRCPC Director of Cardiology Military Hospital, Jeddah

Transcription

1 Device Implantation: Long-Term Commitments Fayez Bokhari, MD, FRCPC Director of Cardiology Military Hospital, Jeddah

2 Who should Implant ICD? 1. Electrophysiologist 2. Surgeons 3. General Cardiologist with interest in implantation 4. Anyone Doctor with adequate implantation training

3 Non EP dealing with an ICD:

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5 5% Estimated Annual Incidence and Growing 1% Infection 0.5% infection rate for new implants 2-7% infection rate for replacements/upgrades 2.5% Malfunction 1.65%-20% annual ICD lead failure based on age 0.5% Occlusion 9-35% of device replacement or upgrade 1% Redundant +Advisory Leads +MRI Conditional

6 Infection Many infection patients may be under-diagnosed 59% Pocket Infection 41% Endovascular Infection 37 (intact pocket)* >40% of all patients involve difficultto-diagnose endovascular infections Diagnosis usually made by combining clinical findings with microbiology and echocardiographic imaging studies *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

7 Rising Rates of Device Infections Figure 1. Proportional increase in cardiac devices implanted and those infected by year of hospitalization, normalized to the number of devices implanted and infected in 1996, respectively. Note the dramatic increase in device infections compared with device implantations, after Voight, A et al. JACC :

8 Mortality Lower mortality risk for laser lead extraction procedure than with infection and co-morbidities 14% 12% 12.4% 10% 8% 7.9% 6% 4% 4.3% 2% 0% 0.28% 0.3% 1.7% Laser-assisted Lead Extraction Procedure No Infection Pocket Infection Device-related Endocarditis (DRE) DRE + Diabetes DRE + Renal Insufficiency* * Creatinine 2.0 mg/dl

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10 Advisory Leads- Sprint Fidelis 15.5% failure at 99 months, increasing about 1.8% per year 18 20% of 97 functioning Fidelis leads removed for reasons other than malfunction had evidence of fracture not due to lead extraction. Sprint Fidelis Model 6949 Lead Performance May 2013 Fidelis is a registered trademark of Medtronic.

11 Advisory Leads- Riata Riata's manufacturer, St. Jude Medical Inc., recalled these leads on Nov. 28, 2011, due to premature erosion of the insulation around the electrical conductor wires, known as insulation failure. 22 Inside-out abrasion involves conductors being visible outside of the lead body through x-ray or fluroscopy. 20 Even moderate changes in lead impedance within normal limits at follow-up should prompt careful fluoroscopic evaluation 21 Since insulation defects at the level of the tricuspid valve occur late during follow-up, routine fluoroscopic examination of leads should be advised prior to elective generator change. 21 Riata is a registered trademark of St. Jude Medical.

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13 Implantable cardioverter defibrillator (ICD) implantation carries a significant risk of complications

14 Complication rates in randomised controlled trials (RCTs) compared to registry. Vivienne A Ezzat et al. Open Heart 2015;2:e by British Cardiovascular Society

15 a contemporary systematic review using meta-analysis of ICD complications in randomised controlled trials (RCTs) and compare it to recent data from the largest international ICD registry, the US National Cardiovascular Data Registry (NCDR). PubMed was searched for any RCTs involving ICD implantation published ; 18 were identified for analysis including 6433 patients, mean follow-up 3 months 5.6 years. Exclusion criteria were studies of children, hypertrophic cardiomyopathy, congenital heart disease, resynchronisation therapy and generator changes. Total pooled complication rate from the RCTs (excluding inappropriate shocks) was 9.1%, including displacement 3.1%, pneumothorax 1.1% and haematoma 1.2%. Infection rate was 1.5%. There were no predictors of complications but longer follow-up showed a trend to higher complication rates (p=0.07).

16 Baseline characteristics of the included studies Trial Year N Mean Follow-up (months) Mean age (years) Per cent male Mean EF (%) Per cent IHD Per cent DM 1 Calkins et al23 SCV vs cephalic approach NA NA 2 Deisenhofer et al24 Dual vs single chamber NA 67 NA 3 Kron et al8 AVID Bänsch et al25 CAT NA 5 Moss et al26 MADIT Vollman et al vs NA 7 Bänsch et al NA NA NA 8 Bokhari et al29 CIDS subset Hohnloser et al30 DINAMIT Kadish et al11 DEFINITE Bänsch et al31 Quick-ICD NA 12 Reddy et al32 SMASH-VT Almendral et al10 DATAS Russo et al33 INTRINSIC RV NA Steinbeck et al7 IRIS Kuck et al34 VTACH NA 17 Varma et al35 TRUST NA 18 Cheng et al36 Warfarin Summary estimate

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18 A total of 532 patients (pooled event rate 9.1%) had an ICD-related complication. All complications were considered to be major in that they required intervention or further hospitalisation. Access-related: pneumothorax, haemothorax, haematoma (including need for transfusion) and thrombosis. Lead-related: dissection or perforation (to include tamponade), displacement, fracture, undersensing or oversensing, insulation defects and the need for any lead revision regardless of cause. Generator-related: This includes generator failure and any need for generator revision, for example, migration or erosion. Infection: requiring intervention, including the use of antibiotic therapy or device extraction.

19 Complications Access-related, n (%) Lead-related, n (%) Patients, n All events, n (%) Total Pneumothorax Haematoma Total Displacement Generatorrelated, n (%) Infection, n (%) Calkins et al (2.8) 1 (1.4) 1 (1.4) 1 (1.4) 1 (1.4) 0 Deisenhofer et al (10.9) 2 (2.2) 1 (1.1) 1 (1.1) 8 (8.7) 0 Kron et al (12.6) 16 (3.0) 6 (1.1) 8 (1.5) 31 (5.8) 11 (2.0) 7 (1.3) 14 (2.6) Bänsch et al (28) 2 (4.0) 2 (4.0) 10 (20.0) 9 (18) 2 (4.0) Moss et al (2.4) 13 (1.8) 5 (0.7) Vollman et al (11.8) 45 (8.3) 8 (1.5) Bänsch et al (19.6) 20 (19.6) 9 (8.8) Bokhari et al (35) 18 (30) 2 (3.3) 3 (5.0) Hohnloser et al (8.1) 7 (2.3) Kadish et al (5.7) 5 (2.2) 1 (0.4) 1 (0.4) Bänsch et al (1.6) 1 (0.5) 1 (0.5) 2 (1.1) 1 (0.5) Reddy et al Almendral et al (9.0) 11 (3.3) 4 (1.2) 4 (1.2) 15 (4.5) 13 (3.9) 4 (1.2) Russo et al (4.6) 15 (1.0) 15 (1.0) 33 (2.2) 23 (1.5) 38 (2.5) Steinbeck et al (18.3) Kuck et al (14.0) 6 (5.6) 4 (3.7) 7 (6.5) 1 (0.9) Varma et al (6.0) Cheng et al (6.3) Event rate, % (95% CI) 9.1 (6.4 to 12.6) 2.1 (1.3 to 3.3) 1.1 (0.6 to 1.8) 1.2 (0.9 to 1.7) 5.8 (3.3 to 9.8) 3.1 (1.7 to 5.8) 2.7 (1.3 to 5.7) 1.5 (0.8 to 2.6)

20 On meta regression the only variable showing a relationship with complication rate was length of follow-up (p=0.07). A 6-month increase in followup time was associated with a 15% increase in complication rate (95% CI 2% to 34% increase).

21 The largest registry population of ICD patients is the US National Cardiovascular Data Registry (NCDR) ICD registry: Relationship between physician procedure volume and ICD complication published in 2012, included initial ICD implantations performed between 2006 and In contrast, data from the NCDR ICD, reporting on implants ( ) showed a statistically significant threefold lower total major complication rate of 3.08% with lead displacement 1.02%, haematoma 0.86% and pneumothorax 0.44%.

22 Given the slightly more contemporary nature of the registry data it is possible that the lower complication rate reflects increased operator experience and improved device/lead technology This may reflect under-reporting of complications in registries. Reporting of ICD complications in RCTs and registries is very variable and there is a need to standardise classification of complications internationally. In addition, patients enrolled in RCTs may potentially be treated by the more experienced operators of a centre while procedures in registry patients might conceivably be performed by operators with a wider range of experience.

23 In a recently published Danish registry experience, the total complication rate for any cardiovascular implantable electronic device (CIED) was reported as 9.5%. This study included all patients on the Danish Pacemaker and ICD Register undergoing a CIED procedure from May 2010 to April The authors concluded that CIED complications are more frequent than generally acknowledged.

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29 Venous Occlusion Occlusions may pose a significant challenge during a device upgrade or a malfunctioning lead replacement Occlusion Management Options Laser lead extraction Implant a new system on contralateral side Tunnel leads from contralateral side Implant and tunnel an epicardial lead Venoplasty to gain access Image courtesy of Dr. Avi Fischer

30 Growing Need for Lead Extraction Expanded Indications from 14 to 30 CATEGORY INDICATION CLASS Infection Pocket infection I Occult gram-positive bacteremia I Occult gram-negative bacteremia IIa Chronic Pain Severe chronic pain IIa Occlusion Ipsilateral occlusion w/o contralateral contraindication IIa Functional Lead Due to design or failure, may pose immediate threat I Risk of interference with device operation IIb Due to design or failure poses potential future threat IIb Functional leads not being used (ICD upgrade) IIb To permit the implantation of an MRI conditional CIED system IIb Need MRI with no other imaging options for diagnosis IIb Non Functional Lead Implant would require > 4 leads on one side or >5 leads through SVC IIa Need MRI with no other imaging options for diagnosis IIa To permit the implantation of an MRI conditional CIED system IIb Non functional lead at device/lead procedure IIb HRS indications for lead extraction apply only to those patients in whom the benefits of lead removal outweigh the risks when assessed based on individualized patient factors and operator specific experience and outcomes. See HRS consensus document Class III indications for when lead removal is not recommended.

31 MRI Contraindication Capped & Abandoned leads are a major contraindication for MRI MRI is the gold standard diagnostic tool for soft tissue imaging for neurologists, oncologists, and orthopedic surgeons. It is estimated that up to 75% of pacemaker patients will have a medical need for an MRI over the lifetime of their device.

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40 ICD interrogation for one of the device shocks

41 The patient was admitted over the weekend The patient had a cardiac arrest the day before EP Check and died! ICD interrogation for the last device shock VP VP

42 A shock (Rx1 Defib) was given for the device diagnosis of VF. Oversensing of the atrial signal by the ICD lead causing double counting and inappropriate shocks. DDx: 1.T wave oversense due to T wave amplitude/ morphology changes e.g. hyperkalaema 2.T wave oversense due to QT interval change e.g. antiarrhythmia drugs 3.Artefacts due to lead fracture 4.Electromagnetic interference

43 ICD shocks can be associated with: Anxiety, 1 healthcare utilization, 2 decreased quality of life, 3 and mortality 4 ICD trials show inappropriate shock rates up to 21% 30% of all shocked episodes are inappropriate 5 Incidence of Inappropriate Shocks in the ICD Population 20 months MADIT-II 6 29 months DEFINITE 7 45 months SCD- HeFT 8 5 years ALTITUDE 9 1 Sears SF Jr, et al. Clin Cardiol. 1999;22: Sweeney MO, et al. Heart Rhythm. 2010;7: Schron EB, et al. Circulation. 2002;105: Poole JE, et al. NEJM. 2008;359: Powell BD, et al. Pacing Clin Electrophysiol. 2012;35: Daubert JP, et al. JACC. 2008;51: Kadish A, et al. NEJM. 2004;350: Poole JE, et al. NEJM. 2008;359: Saxon LA, et al. Circulation. 2010;122:

44 Causes of Inappropriate Shocks SmartShock Technology 20% 65% Supraventricular Tachycardia Wavelet + PR Logic SVT Discriminators in VF Zone Oversensing/Artifact T-Wave Discrimination Lead Integrity Alert Lead Noise Discrimination Non-Sustained Ventricular Tachycardia Confirmation+ 1 XXXX 1 Poole, et al. NEJM 2008;359:

45 Conclusion It is clearly evident that implantation of an ICD/pacing lead carries a significant risk of immediate and long-term complications with 1/20 patients suffering a complication. This is a reflection of the limitations of current implantation techniques Furthermore, even in the best hands acute lead stability remains an issue. These factors are compounded by the limited longevity of leads and possibility of multiple replacements particularly in younger patients. The emergence of subcutaneous ICD and now leadless pacing systems may limit some of these complications.

46 EP dealing with an ICD.

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48 Causes for inappropriate therapy (Shock or ATP) atrial arrhythmias (AF, atrial flutter, SVT) oversensing due to lead fracture noise or overcounting (Twave oversensing, EMI, myopotentials) Causes for unnecessary therapy (Shock or ATP) Too aggressive treatment of VT than absolutely required shock or ATP for premature detection of non-sustained VT; premature ATP may accelerate NSVT Shock for sustained pace-terminable VT