ESC CONGRESS – Barcelona, Spain

1. Executive Committee: Maria Grazia Bongiorni,  IT  (Chair) Charles Kennergren,  SE  (Co-chair) Christian Butter,  DE    Jean-Claude Deharo,  FR      Andrzej Kutarski,  PL Aldo Rinaldi,  UK Aldo P. Maggioni,  IT Carina Blomstrom-Lundqvist,  SE  Angelo Auricchio,  CH     Karl-Heinz Kuck,  DE    ELECTRa (European Lead Extraction ConTRolled) Registry: preliminary data on TransvenousLead Extraction in Europe ESC CONGRESS – Barcelona, Spain AUGUST 30, 2014 Maria Grazia Bongiorni, MD, FESC ELECTRa Registry Chair University Hospital of Pisa (IT)

2. Background In recent years the number of CIED complications increased because of: • Increase of device implantation per year • More complex procedures • Sicker and high risk patients Transvenous Lead Extraction is the gold standard in the treatment of CIED-related infective complications and is often required in the management of lead malfunction TLE is unexplored across European countries regarding appropriate indications, tools, techniques, success rate and complications in acute and long-term follow-up

3. ELECTRa: Objectives The ELECTRa (European Lead Extraction ConTRolled) Registry is a prospective, multicentre registry of patients undergoing Transvenous Lead Extraction in ESC countries Primary objective: To evaluate the acute and long-term safety of TLE Secondary objectives: • To describe characteristics of patients and leads undergoing TLE procedure • To evaluate indications, tools and techniques for TLE procedures • To assess the acute and chronic outcomes of TLE procedures • To compare outcomes between low and high volume centers

4. ELECTRa: Study design Recruitment of patients started on November 2012 and ended on May 2014 All consecutive patients with indications for TLE (following HRS consensus document) in the participating centres during the enrolment period were included Data were collected using a web based system and audited at randomly selected centres No specific protocol for the procedure, materials, techniques of extraction, or treatment after the procedure was mandatory during this observational study High and low volume centres were defined on the basis of their volume of activity at the end of the study calculating the median number of patients enrolled/month/centre

5. ELECTRa: Enrollments 19 participating countries 76 enrolling centres 3524 enrolled pts

6. ELECTRa: Patient characteristics • N= 3 524 pts Demographics Clinical History Risk factors Concomitant Diseases Risk factors & Concomitant Diseases

7. ELECTRa: Devices

8. ELECTRa: TLE Indications

9. ELECTRa: Leads characteristics • Total Leads Extracted = 6 433

10. ELECTRa Outcomes:Major complications Major complication: Any of the outcomes related to the procedure which is life threatening or results in death. In addition, any unexpected event that causes persistent or significant disability or any event that requires significant surgical intervention. 1. Death 2. Cardiac avulsion or tear requiring thoracotomy, pericardiocentesis, chest tube or surgical repair 3. Vascular avulsion or tear requiring thoracotomy, pericardiocentesis, chest tube or surgical repair 4. Pulmonary embolism requiring surgical intervention 5. Respiratory arrest or anesthesia related complication leading to prolongation of hospitalization 6. Stroke 7. Pacing system related infection of a previously non-infected site Wilkoff BL, Love CJ, Byrd CL, Bongiorni MG, Carrillo RG, Crossley GH, Epstein LM, Friedman RA, Kennergren CEH, Mitkowski P, Schaerf RHM, Wazni OM: Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities,training, indications, and patient management: this document was endorsed by the American Heart Association (AHA). Heart Rhythm 2009;6:1085–104

11. ELECTRa Outcomes:Major complications P=0.0389 P=0.0446 P=0.9668 P=0.0875 Intra-procedural complications: Any event related to the performance of a procedure that occurs or becomes evident from the time the patient enters the operating room until the time the patient leaves the operating room. Post-procedural: Any event related to the procedure that occurs or becomes evident pre-discharge. • High Volume Centre > 2.5 pts/month • Low volume Centre ≤ 2.5 pts/month (Wilkoff BL et al. Heart Rhythm 2009;6:1085–104) • % of major complications calculated on the database • using locked patients with TLE done • (N= 3479 pts)

12. ELECTRa Outcomes:Major complications P=0.0153 • % of major complications calculated on the database • using locked patients with TLE done • (N= 3479 pts)

13. ELECTRa Outcomes:Minor complications Minor complication: Any undesired event related to the procedure that requires medical intervention or minor procedural intervention to remedy, and does not limit persistently or significantly the patient’s function, nor threaten life or cause death. 1. Pericardial effusion non requiring pericardiocentesis or surgical intervention 2. Hemothorax not requiring a chest tube 3. Hematoma at the surgical site requiring reoperation for drainage 4. Arm swelling or thrombosis of implant vein resulting in medical intervention 5. Vascular repair near the implant site or venous entry site 6. Hemodynamically significant air embolism 7. Migrated lead fragment without sequelae 8. Blood transfusion related to blood loss during surgery Wilkoff BL, Love CJ, Byrd CL, Bongiorni MG, Carrillo RG, Crossley GH, Epstein LM, Friedman RA, Kennergren CEH, Mitkowski P, Schaerf RHM, Wazni OM: Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities,training, indications, and patient management: this document was endorsed by the American Heart Association (AHA). Heart Rhythm 2009;6:1085–104

14. ELECTRa Outcomes:Minor complications P=0.0002 P=0.0038 P=0.0166 P=0.7111 • % of major complications calculated on the database • using locked patients with TLE done • (N= 3479 pts)

15. ELECTRa Outcomes: Radiological Success rate Radiological Success Removal of all targeted leads and all lead material from the vascular space, with the absence of any permanently disabling complication or procedure related death. Partial = less than 4 cm remains in the cardiovascular system (Wilkoff BL et al. Heart Rhythm 2009;6:1085–104)

16. ELECTRa Outcomes:Clinical Success rate Clinical success Based on the achievement of clinical outcome according to intention to treat defined as “removal of all targeted leads and lead material from the vascular space, or retention of a small portion of the lead that does not negatively impact the outcome goals of the procedure. (Wilkoff BL et al. Heart Rhythm 2009;6:1085–104)

17. Conclusions ELECTRA Registry is the first large prospectic registry on Transvenous Lead Extraction conducted in the ESC countries Infective and non infective indications are almost equally considered in clinical practice for this kind of intervention The radiological success rate is more than 95% and the assumed clinical success rate is extremely high (98,3%) Major and Minor complications are more frequent in low volume centers and mainly in the post-operative period An accurate analysis of all data collected will give us details about the real world on TLE and will make possible a better knowledge to further improve the outcomes

18. ExecutiveCommittee: Maria Grazia Bongiorni,  IT  (Chair) Charles Kennergren,  SE (Co-chair) Christian Butter,  DE    Jean-Claude Deharo,  FR      Andrzej Kutarski,  PL Aldo Rinaldi,  UK Aldo P. Maggioni,  IT Carina Blomstrom-Lundqvist,  SE  Angelo Auricchio,  CH     Karl-HeinzKuck,  DE Research Fellow: Simone Lorenzo Romano, IT EORP Team: Aldo P. Maggioni, Scientific Coordinator Thierry Ferreira, Head of Department Cecile Laroche, Statistician Charles Taylor, IT Specialist Gerard Gracia, Data MonitorViviane Missiamenou, Data MonitorMarèmeKonte, Data MonitorMarynaAndarala, Data Monitor EmanuelaFiorucci, Project OfficerPatti-Ann McNeill, Project OfficerMyriam Glémot, Project Officer ElinFolkesson, Project OfficerCaroline Pommier, Administrative Assistant We express one's thanks to: