esc congress – barcelona, spain

EURObservational Research Programme

ESC CONGRESS – Barcelona, SpainESC CONGRESS – Barcelona, Spain

AUGUST 30, 2014AUGUST 30, 2014

Maria Grazia Bongiorni, MD, FESCELECTRa Registry Chair University Hospital of Pisa (IT)

ELECTRa ELECTRa (European Lead Extraction ConTRolled) (European Lead Extraction ConTRolled)

Registry: Registry: preliminary data on Transvenous Lead preliminary data on Transvenous Lead

Extraction in EuropeExtraction in Europe

Executive Committee:

Maria Grazia Bongiorni, IT (Chair) Charles Kennergren, SE (Co-chair) Christian Butter, DE Jean-Claude Deharo, FR Andrzej Kutarski, PL Aldo Rinaldi, UKAldo P. Maggioni, ITCarina Blomstrom-Lundqvist, SE Angelo Auricchio, CH Karl-Heinz Kuck, DE


2ELECTRa Registry Status Report – ESC CONGRESS, Barcelona, Spain - 31 August 2014

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



ELECTRa: Objectives

• 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

The ELECTRa (European Lead Extraction ConTRolled) Registry is a prospective, multicentre registry of patients undergoing Transvenous Lead Extraction in ESC countries



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



ELECTRa: Enrollments

19 participating countries

76 enrolling centres

3524 enrolled pts



ELECTRa: Patient characteristicsN= 3 524 pts

Clinical HistoryDemographics

Risk factors & Concomitant Diseases

Concomitant Diseases

Risk factors



ELECTRa: Devices



ELECTRa: TLE Indications



ELECTRa: Leads characteristics

Total Leads Extracted = 6 433



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



% of major complications calculated on the database using locked patients with TLE done

(N= 3479 pts)


High Volume Centre > 2.5 pts/month

Low volume Centre ≤ 2.5 pts/month

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.

(Wilkoff BL et al. Heart Rhythm 2009;6:1085–104)

P=0.0446

P=0.9668

P=0.0875

P=0.0389




P=0.0153


(N= 3479 pts)



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



ELECTRa Outcomes:Minor complications

P=0.0166

P=0.0038

P=0.7111

P=0.0002


(N= 3479 pts)



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




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.

ELECTRa Outcomes:Clinical Success rate




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


Executive Committee:

Maria Grazia Bongiorni, IT (Chair) Charles Kennergren, SE (Co-chair) Christian Butter, DE Jean-Claude Deharo, FR Andrzej Kutarski, PL Aldo Rinaldi, UKAldo P. Maggioni, ITCarina Blomstrom-Lundqvist, SE Angelo Auricchio, CH Karl-Heinz Kuck, DE

Research Fellow:

Simone Lorenzo Romano, IT

EORP Team:

Aldo P. Maggioni, Scientific CoordinatorThierry Ferreira, Head of Department Cecile Laroche, StatisticianCharles Taylor, IT SpecialistGerard Gracia, Data MonitorViviane Missiamenou, Data MonitorMarème Konte, Data MonitorMaryna Andarala, Data MonitorEmanuela Fiorucci, Project OfficerPatti-Ann McNeill, Project Officer Myriam Glémot, Project OfficerElin Folkesson, Project Officer Caroline Pommier, Administrative Assistant

We express one's thanks to:

esc congress – barcelona, spain

Documents