Principali complessitàcliniche e gestionali dell ... · Principali complessitàcliniche e gestionali dell’estrazione di elettrocateteri. ... New indication for device treatment

Maria Grazia Bongiorni,Direttore UOC Cardiologia 2

Azienda Ospedaliero –Universitaria - Pisa

Principali complessità cliniche e gestionali dell’estrazione di elettrocateteri

Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)

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

Indications for lead ExtractionIndications for lead Extraction

PAPERS PUBLISHED ON LEAD EXTRACTIONPAPERS PUBLISHED ON LEAD EXTRACTIONPAPERS PUBLISHED ON LEAD EXTRACTION

Ovid Medline 1999-2013

LEAD EXTRACTIONSLEAD EXTRACTIONS

SUCCESS & COMPLICATIONS IN CLINICAL PRACTICESUCCESS & COMPLICATIONS IN CLINICAL PRACTICE

Maytin M. et al. Heart 2011;97:425-34

Infection Rates(estimated from National Hospital Discharge Survey)

Voigt A, et al, PACE 2010; 33(4) 414–419

Why?

� Patients with more co-morbidities– “Sicker Patients”

� Larger Devices– More ICDs

� Longer implant time– Less experienced implanters

– More complex devices

� “Cathlab sterile technique”

Odds ratio for developing CIED Infection

Klug D et al. Circulation 2007;116(12):1349-1355. - Lekkerkerker JC et al. Heart 2009;95(9):715-720.Margey R et al. Europace 2010;12(1):64-70. - Sohail MR et al. Clin Infect Dis. 2007;45(2):166-173.Bloom H et al. Pacing Clinical Electrophysiology 2006;29(2):142-145.


E. Durante Mangoni et al. Intern Emerg Med 2012

Diagnosis Diagnosis


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


Baddour LM et al, Circulation 2010; 121:458-477


THERAPYTHERAPY

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.

Antibiotic Therapy


Mortality after CIEDs infectionsMortality after CIEDs infectionsStudy (year) Population Time period Patients (n) Outcomes

Voigt et al

2006

CIED infection vs

control

1996-2003 CIED infection increase in-hospital

mortality 2 fold

Sohail et al

2007

CIED infection

patients

1991-2003

retrosp.

189 (69% local,

23% systemic)

In hospital mortality 3.7 %

Baman et al

2009

CIED infection

patients, 89%TLE

1995-2006

retrosp.

210 (65% local,

34% systemic)

In hospital mortality 8%

6-month mortality 18%

Tarakji er al

2010

CIED infection

patients, TLE

2002-2007

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

1991-2008,

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

2000-2009 2476. 64 (2.6%

TLE for CIED

infection)

2 fold increase in mortality in CIED

infection group

Deharo et al

2012

CIED infection vs

uninfected

2004-2008 CIED infection

197 (41% local,

59% systemic)

1 year mortality 14.3% in infected

vs 11% in uninfected CIEDs

Sohail et al

2011

200.219 pts impl.,

repl. revision

1/1/2007 -

31/12/2007

5187 CIED

infection

Mortality rate with inf 4.6-11.3%,

w/o infection 27.4-36.3%

Athan et al

2012

2760 patients with

endocarditis

2000-2006 171 with CIED

endocarditis

In-hospital mortality 14.7%

1 year mortality 32.2 %

Tarakji KG and Wilkoff BL Expert Rev Cardiovasc Ther 2013

Optimal treatment of CIED Infections

ClinicianClinician Infectious DiseasesInfectious DiseasesSpecialistSpecialist

ArrhythmologistArrhythmologistSurgeonSurgeon

CIEDCIEDInfectionsInfections

ComorbiditiesComorbiditiesMultiorgan failureMultiorgan failure

-- Effects of antimicrobial Effects of antimicrobial therapytherapy

Lead ExtractionLead ExtractionAcute and longtermAcute and longterm

AntibioticsAntibioticsPre and PostPre and Post --extractionextraction

INTEGRATED, MULTIDISCIPLINARY APPROACH

Lead extractionLead extraction

TOOLS TOOLS

TECHNIQUES TECHNIQUES

VENOUS APPROACHESVENOUS APPROACHES





1. Venous Entry Approach: using the implant vein1. Venous Entry Approach: using the implant vein

2. Inferior Approach or Femoral Approach2. Inferior Approach or Femoral Approach

3. Internal Jugular Approach 3. Internal Jugular Approach

Transvenous Lead Extraction Approach

13

2


Importance of coaxial orientation of any sheath to avoid vascular injury

TRANSVENOUS LEAD REMOVAL


RG Hauser et al Europace 2010; 12: 395-401

SVC laceration 18/28 = 64%Haemopericardium 2/6 = 33%Innominate vein tear 1/4 = 25%RA tear 1/4 = 25%

Hypotension 3, Haemorrhage 2, RV perforation 1 Unspecified 2,Pulmonary embolus 1

FATAL IN (%)FATAL IN (%)COMPLICATIONCOMPLICATION

OTHER CAUSES OF DEATHOTHER CAUSES OF DEATH

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


Major Complications

Death

Cardiac avulsion requiring intervention(percutaneous or surgical)

Vascular Injury requiring intervention(percutaneous or surgical)

Pulmonary embolism requiring surgicalIntervention

Respiratory arrest/anesthesia related complicationprolonging 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 inmedical treatment

Haemodynamically significant air embolism

Migrated lead fragment without sequelae

Blood transfusion as a result of intraoperativeblood loss

Pneumothorax requiring chest tube

Pulmoary embolism not requiring surgicalintervention

Potential complications of transvenous lead extraction

Hearth Rhythm July 2009


Factors affecting outcomeFactors affecting outcome

PATIENT-RELATED- Gender, Age, BMI

- Comorbidities

- Infections

- Diabetes

- Renal Failure

LEAD-RELATED- Type , Number and position

- Dwelling time

- Lead damage

TEAM-RELATED- Experience and Volume

- Staff training

- Surgical back-up

TOOLS-TECHNIQUES AND APPROACHES RELATED- Tools

- Techniques

- Venous Approaches

Division of Cardiovascular Diseases - University Hospital of Pisa (Italy) EHRA position paper 2012


EXTRACTION - REQUIREMENTSEXTRACTION - REQUIREMENTS

PERSONNELPERSONNELPERSONNEL

HRS Expert Consensus 2009, EHRA position paper 2012

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

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

Byrd et al. PACE 2002;25:804-808


PERSONNEL – PRIMARY OPERATOR EXPERIENCEPERSONNEL PERSONNEL –– PRIMARY OPERATOR EXPERIENCEPRIMARY OPERATOR EXPERIENCE


CARDIOTHORACIC SURGEON:

• IMMEDIATELY AVAILABLE

• IS AWARE OF PROCEDURE

• ABLE TO MANAGE LIFE-THREATENING COMPLICATIONS

CARDIOTHORACIC SURGEON:

• IMMEDIATELY AVAILABLE

• IS AWARE OF PROCEDURE

• ABLE TO MANAGE LIFE-THREATENING COMPLICATIONS


PERSONNELPERSONNELPERSONNEL

SUCCESS & COMPLICATIONS IN CLINICAL PRACTICESUCCESS & COMPLICATIONS IN CLINICAL PRACTICE

Hauser R.G. et al. Europace 2010;12:395-401

ASSIST DEVICES COMPLICATIONSASSIST DEVICES COMPLICATIONSDBASES: US Food and Drug Administration (FDA), Manufacturers and User Defined Experience (MAUDE)

1995-2008: 57 death, 48 seriuous cardiovascular injuries

Tool n Number of events

Death Injury

LALE 45 25 20

SVC/RA/IV tear 31 17 14

RV perforation 1 1 0

Hypotension 3 3 0

Haemopericardium 5 1 4

Pulmonary embolus 1 1

SC artery laceration 1 1

Haemothorax 1 1

Unspecified 2 2

SCV/RA/IV tear survival rate – 45%


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

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


PERSONNEL – PRIMARY OPERATORPERSONNEL PERSONNEL –– PRIMARY OPERATORPRIMARY OPERATOR

EHRA position paper 2012

REQUIREMENTS - GENERAL:

• HOSPITAL WITH CARDIOTHORACIC SURGERY, ANGIOGRAPHY AND PACEMAKER LABORATORY

• FULL RANGE OF EXTRACTION (AND OTHER) TOOLS

REQUIREMENTS - GENERAL:

• HOSPITAL WITH CARDIOTHORACIC SURGERY, ANGIOGRAPHY AND PACEMAKER LABORATORY

• FULL RANGE OF EXTRACTION (AND OTHER) TOOLS

LEAD EXTRACTION ENVIRONMENTLEAD EXTRACTION ENVIRONMENT

LEAD EXTRACTION CENTERLEAD EXTRACTION CENTERLEAD EXTRACTION CENTER

PATIENTPATIENT LEADLEAD

TIMETIME

TEAMTEAM

(Facilities,(Facilities,

Experience)Experience)

Lead Extraction: The Devil’s Triangle


Superior ApproachSuperior Approach using using the implant veinthe implant veinExposed leadsExposed leads

Internal Jugular ApproachInternal Jugular Approach

(in case of free(in case of free--floating leads or floating leads or difficult exposed leadsdifficult exposed leads

Progressive dissection with single twisting sheath Progressive dissection with single twisting sheath

(mechanical dilatation)(mechanical dilatation)

When dilatation was stopped at any binding site for 5 min, or when dilatation was judjed too risky, the Internal Jugular Approach was considered.

PERSONAL TECHNIQUE

Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)Division of Cardiovascular Diseases - University Hospital of Pisa (Italy)

PatientsPatients 20292029

Age, meanAge, meanrangerange

65.665.633--9595

Sex M / FSex M / F 1546/4831546/483

LeadsLeads 36883688

Mean pacing period (months)Mean pacing period (months)rangerange

71.2 71.2 11--420420

Pacing / Defibrillating leadsPacing / Defibrillating leads 3044/6443044/644

Exposed / IntravascularExposed / Intravascular 3597/913597/91

Patients and Leads CharacteristicsPatients and Leads Characteristics(January 1997 (January 1997 –– June 2013)June 2013)


RESULTS

CLINICAL SUCCESS=98.5%

(January 1997 – June 2013)2029 Patients - 3688 Leads


Cardiac Tamponade Cardiac Tamponade 1111(Fatal)(Fatal) 22

Major ComplicationsMajor Complications(0,6%)(0,6%)

Deaths 3/2029 pts (0,15%)

HemothoraxHemothorax 1 1 (Fatal)(Fatal) 11

7F / 5M (Mean age 75,3 y) (range 65-86)

NO SVC TearsNO SVC Tears

(January 1997 – June 2013)2029 Patients - 3688 Leads

REQUIREMENTS TO PERFORM LEAD EXTRACTIONSREQUIREMENTS TO PERFORM LEAD EXTRACTIONS

SURVEY

REGISTRY

SURVEYSURVEY

REGISTRYREGISTRY


Study design and method

This is the first large prospective, multicentre, European Controlled Registry of

consecutive patients undergoing TLE procedures in European Countries.

(EuropeanLead Extraction ConTRolled Registry)

ELECTRa Registry

• About 100 centres were invited to participate in the registry from 25 countries.

• Each centre 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.

First large Prospective, multicentre, European Controlled Registry of

consecutive patients undergoing TLE procedures

in European Countries

Prospective

Controlled

ELECTRa Registry(EuropeanLead Extraction ConTRolled Registry)

Executive Committee

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)

ELECTRa RegELECTRa Registryistry

EURObservational Research Programme

Thierry Ferreira - Head of department EORP

Gérard Gracia Data MonitorViviane Missiamenou Data MonitorMarème Konte Data MonitorMaryna Andarala Data MonitorCécile Laroche StatisticianCharles Taylor IT Specialist

Patti-Ann McNeill AssistantMyriam Glemot AssistantEmanuela Fiorucci AssistantMyriam Lafay Assistant

Simone Romano Fellow

•

Regional Coordinators

Maria Grazia Bongiorni

Charles Kennergren

Christian Butter

Jean-Claude Deharo

Andrzej Kutarski

Aldo Rinaldi 41

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

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.

ELECTRa Registry

ELECTRa Registry

44

ELECTRa Registry

ELECTRa Registry

> 200 Pts enrolled

> 50 Pts enrolled

< 50 Pts enrolled

30/09/2013 STATUS REPORT :

ELECTRa: Trend of

Recruitment

Approaching lead extractionApproaching lead extraction

Grazie per lGrazie per l’’ attenzioneattenzione

Documents

Principali complessitàcliniche e gestionali dell ... · Principali complessitàcliniche e gestionali dell’estrazione di elettrocateteri. ... New indication for device treatment