Principali complessitàcliniche e gestionali dell estrazione di elettrocateteri
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1 Principali complessitàcliniche e gestionali dell estrazione di elettrocateteri Maria Grazia Bongiorni, Direttore UOC Cardiologia 2 Azienda Ospedaliero Universitaria - Pisa
2 Indications for lead Extraction The need for lead extraction is rapidly increasing due to: New indication for device treatment Higher lead prevalence due to increased life expectancy CIED modes requiring more leads for patient Upgrading from device systems becoming more frequent Lead Recalls and malfunctions Lead Infections Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
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5 LEAD EXTRACTIONS PAPERS PUBLISHED ON LEAD EXTRACTION Ovid Medline
6 SUCCESS & COMPLICATIONS IN CLINICAL PRACTICE Maytin M. et al. Heart 2011;97:425-34
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8 Infection Rates (estimated from National Hospital Discharge Survey) Voigt A, et al, PACE 2010; 33(4)
9 Why? Patients with more co-morbidities Sicker Patients Larger Devices More ICDs Longer implant time Less experienced implanters More complex devices Cathlab sterile technique
10 Odds ratio for developing CIED Infection Klug D et al. Circulation 2007;116(12): Lekkerkerker JC et al. Heart 2009;95(9): Margey R et al. Europace 2010;12(1): Sohail MR et al. Clin Infect Dis. 2007;45(2): Bloom H et al. Pacing Clinical Electrophysiology 2006;29(2):
11 Diagnosis E. Durante Mangoni et al. Intern Emerg Med 2012 Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
12 CIED infection is a serious complication associated with sustantial morbidity, mortality and costs. CIED infection increases the risk of in-hospital death by more than 2 fold Division of Cardiovascular Diseases - University Hospital of Pisa (Italy) Baddour LM et al, Circulation 2010; 121:
13 THERAPY Antibiotic Therapy Transvenous Lead Extraction Although clinical presentation might be different, the management of both pocket infection or systemic infection is very similar and involves complete system removal and antibiotic therapy. The type of infection might affect the duration of antibiotic therapy and the decision for timing and type of reimplant. Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
14 Mortality after CIEDs infections Study (year) Population Time period Patients (n) Outcomes Voigt et al 2006 CIED infection vs control CIED infection increase in-hospital mortality 2 fold Sohail et al 2007 CIED infection patients retrosp. 189 (69% local, 23% systemic) In hospital mortality 3.7 % Baman et al 2009 CIED infection patients, 89%TLE retrosp. 210 (65% local, 34% systemic) In hospital mortality 8% 6-month mortality 18% Tarakji er al 2010 CIED infection patients, TLE retrosp. 412 (58% local, 42% systemic) In hospital mortality 4.6%, 1 year mortality 17%(12%L,25%S) Le et al 2011 CIED infection patients , retrosp. 416 (9% local) 30-d mortality 5.5% 1 year mortyality 14.6% De Bie et al 2012 All patients underwent ICD or CRT-D implant (2.6% TLE for CIED infection) 2 fold increase in mortality in CIED infection group Deharo et al 2012 CIED infection vs uninfected CIED infection 197 (41% local, 59% systemic) 1 year mortality 14.3% in infected vs 11% in uninfected CIEDs Sohail et al pts impl., repl. revision 1/1/ /12/ CIED infection Mortality rate with inf %, w/o infection % Athan et al patients with endocarditis with CIED endocarditis Division of Cardiovascular Diseases - University Hospital of Pisa (Italy) In-hospital mortality 14.7% 1 year mortality 32.2 % Tarakji KG and Wilkoff BL Expert Rev Cardiovasc Ther 2013
15 Optimal treatment of CIED Infections Clinician Infectious Diseases Specialist CIED Infections INTEGRATED, MULTIDISCIPLINARY APPROACH Comorbidities Multiorgan failure - Effects of antimicrobial therapy Arrhythmologist Surgeon Lead Extraction Acute and longterm Antibiotics Pre and Post-extraction
16 Lead extraction TOOLS TECHNIQUES VENOUS APPROACHES
17 Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
18 Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
19 Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
20 Transvenous Lead Extraction Approach 1. Venous Entry Approach: using the implant vein 1 2. Inferior Approach or Femoral Approach 3. Internal Jugular Approach 3 2 Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
21 TRANSVENOUS LEAD REMOVAL Importance of coaxial orientation of any sheath to avoid vascular injury Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
22 FDA Manufacturers and User Defined Experience (MAUDE) database from 1995 to 2008: 57 deaths and 48 serious cardiovascular injuries associated with device-assisted lead extraction were reported COMPLICATION FATAL IN (%) SVC laceration 18/28 = 64% Haemopericardium 2/6 = 33% Innominate vein tear 1/4 = 25% RA tear 1/4 = 25% OTHER CAUSES OF DEATH Hypotension 3, Haemorrhage 2, RV perforation 1 Unspecified 2, Pulmonary embolus 1 Division of Cardiovascular Diseases - University Hospital of Pisa (Italy) RG Hauser et al Europace 2010; 12:
23 Potential complications of transvenous lead extraction Major Complications Death Cardiac avulsion requiring intervention (percutaneous or surgical) Vascular Injury requiring intervention (percutaneous or surgical) Pulmonary embolism requiring surgical Intervention Respiratory arrest/anesthesia related complication prolonging hospitalisation Stroke CIED infection at previously non-infected site Minor Complications Pericardial effusion not requiring intervention Hemotorax not requiring intervention Pocket haematoma requiring reoperation Upper extremity thrombosis resulting in medical treatment Haemodynamically significant air embolism Migrated lead fragment without sequelae Blood transfusion as a result of intraoperative blood loss Pneumothorax requiring chest tube Pulmoary embolism not requiring surgical intervention Division of Cardiovascular Diseases - University Hospital of Pisa (Italy) Hearth Rhythm July 2009
24 Factors affecting outcome PATIENT-RELATED - Gender, Age, BMI - Comorbidities - Infections - Diabetes - Renal Failure LEAD-RELATED - Type, Number and position - Dwelling time - Lead damage TOOLS-TECHNIQUES AND APPROACHES RELATED - Tools - Techniques - Venous Approaches TEAM-RELATED - Experience and Volume - Staff training - Surgical back-up Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
25 Division of Cardiovascular Diseases - University Hospital of Pisa (Italy) EHRA position paper 2012
26 Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
27 EXTRACTION - REQUIREMENTS PERSONNEL 1. PRIMARY OPERATOR 2. CARDIOSURGEON (IF NOT A PRIMARY OPERATOR), TRAINED TO FIX ACUTE COMPLICATIONS 3. ANESTESIOLOGIST 4. SCRUBBED ASSISTANT 5. NON-SCRUBBED ASSISTANT 6. TECHNICIAN FLUOROSCOPIC EQUIPMENT 7. ECHOCARDIOGRAPHER HRS Expert Consensus 2009, EHRA position paper 2012
28 EXTRACTION - REQUIREMENTS PERSONNEL PRIMARY OPERATOR EXPERIENCE Byrd et al. PACE 2002;25:
29 EXTRACTION - REQUIREMENTS PERSONNEL CARDIOTHORACIC SURGEON: IMMEDIATELY AVAILABLE IS AWARE OF PROCEDURE ABLE TO MANAGE LIFE-THREATENING COMPLICATIONS HRS Expert Consensus 2009, EHRA position paper 2012
30 SUCCESS & COMPLICATIONS IN CLINICAL PRACTICE ASSIST DEVICES COMPLICATIONS DBASES: US Food and Drug Administration (FDA), Manufacturers and User Defined Experience (MAUDE) : 57 death, 48 seriuous cardiovascular injuries Tool n Number of events Death Injury LALE SVC/RA/IV tear SCV/RA/IV tear survival rate 45% RV perforation Hypotension Haemopericardium Pulmonary embolus 1 1 SC artery laceration 1 1 Haemothorax 1 1 Unspecified 2 2 Hauser R.G. et al. Europace 2010;12:
31 EXTRACTION - REQUIREMENTS PERSONNEL PRIMARY OPERATOR IT IS RECOGNIZED THAT IN CASE OF SVC IS TORN OR PERFORATED, DELAYS OVER 5-10 MINUTES TO HAVING OPEN ACCESS TO THE HEART IS OFTEN ASSOCIATED WITH FATAL OUTCOME HRS Expert Consensus 2009, EHRA position paper 2012
32 LEAD EXTRACTION ENVIRONMENT LEAD EXTRACTION CENTER REQUIREMENTS - GENERAL: HOSPITAL WITH CARDIOTHORACIC SURGERY, ANGIOGRAPHY AND PACEMAKER LABORATORY FULL RANGE OF EXTRACTION (AND OTHER) TOOLS EHRA position paper 2012
33 Lead Extraction: The Devil s Triangle PATIENT TIME TEAM (Facilities, Experience) LEAD
34 PERSONAL TECHNIQUE Progressive dissection with single twisting sheath (mechanical dilatation) Superior Approach using the implant vein Exposed leads Internal Jugular Approach (in case of free-floating floating leads or difficult exposed leads When dilatation was stopped at any binding site for 5 min, or when dilatation was judjed too risky, the Internal Jugular Approach was considered. Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
35 Patients and Leads Characteristics (January 1997 June 2013) Patients 2029 Age, mean range Sex M / F 1546/483 Leads 3688 Mean pacing period (months) range Pacing / Defibrillating leads 3044/644 Exposed / Intravascular 3597/91 Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
36 RESULTS (January 1997 June 2013) 2029 Patients Leads CLINICAL SUCCESS=98.5% Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
37 Major Complications (0,6%) (January 1997 June 2013) 2029 Patients Leads 7F / 5M (Mean age 75,3 y) (range 65-86) Cardiac Tamponade 11 (Fatal) 2 Hemothorax 1 (Fatal) 1 Deaths 3/2029 pts (0,15%) NO SVC Tears Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)
38 REQUIREMENTS TO PERFORM LEAD EXTRACTIONS SURVEY REGISTRY HRS Expert Consensus 2009, EHRA position paper 2012
39 ELECTRa Registry (EuropeanLead Extraction ConTRolled Registry) Study design and method This is the first large prospective, multicentre, European Controlled Registry of consecutive patients undergoing TLE procedures in European Countries. About 100 centres were invited to participate in the registry from 25 countries. Eachcentre will register consecutive patients for a total of 3500 patients. Every patient will be enrolled the day before the procedure. All consecutive patients will be followed up to 1 year. Indications to perform procedures will be left to the decision of participating physicians. No specific protocol or recommendations for the procedure, materials, techniques of lead extractions, or treatment after the procedure will be mandated during this observational study.
40 ELECTRa Registry (EuropeanLead Extraction ConTRolled Registry) First large Prospective,multicentre, European ControlledRegistry of consecutive patients undergoing TLE procedures in European Countries Prospective Controlled
41 Executive Committee ELECTRa Registry Maria Grazia Bongiorni (Chair) Charles Kennergren (Co-chair) Christian Butter Jean-Claude Deharo Andrzej Kutarski Aldo Rinaldi Aldo Maggioni (EORP) Carina Blomström-Lundqvist (Chair-SIC) Angelo Auricchio (EHRA President) Regional Coordinators Maria Grazia Bongiorni Charles Kennergren Christian Butter Jean-Claude Deharo Andrzej Kutarski Aldo Rinaldi EURObservationalResearch Programme Thierry Ferreira - Head of department EORP Gérard Gracia Data Monitor Viviane Missiamenou Data Monitor Marème Konte Data Monitor Maryna Andarala Data Monitor Cécile Laroche Statistician Charles Taylor IT Specialist Patti-Ann McNeill Myriam Glemot Emanuela Fiorucci Myriam Lafay Simone Romano Assistant Assistant Assistant Assistant 41 Fellow
42 ELECTRa Registry Primary Objective The primary objective is: To evaluate the acute and Long-Term safety of TLE Measures: Major procedure-related complications (including death) in acute and Long-Term follow-up
43 ELECTRa Registry Secondary Objectives To describe demographic, clinical, and biological characteristics of patients undergoing TLE procedure in a representative setting of European cardiology Centres. To describe the characteristics of leads undergoing extraction. To evaluate indications for TLE procedures. To describe the diagnostic and therapeutic approaches employed in the routine practice of physicians performing TLE procedures. To assess the acute and chronic outcomes of TLE procedures.
44 ELECTRa Registry 44
45 ELECTRa Registry
46 ELECTRa Registry 30/09/2013 STATUS REPORT : > 200 Pts enrolled > 50 Pts enrolled < 50 Pts enrolled
47 ELECTRa: Trend of Recruitment
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49 Approaching lead extraction Grazie per l l attenzione
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