Journal of Geriatric Cardiology(2013)10:39 2013JGC All rights rerved;
Rearch Article Open Access Implantable defibrillator lead extraction with optimized standar d extr action techniques
Xian-Ming Chu1,2,Xue-Bin Li1,Ping Zhang1,Yi An2,Jiang-Bo Duan1,Long Wang1,Ding Li1,Bing Li3, Ji-Hong Guo1
1Dep artment of Cardiac Electrophy siology,Peking University Peop le’s Hospital,B eijing100044,China
2Dep artment of Cardiology,the Affiliated Hospital of Medical College,Qingd ao Univ ersity,Qing dao266100,China
toefl考试
tmds3Dep artmen t of Biology,M edical College of Qing dao Un iv ersity,Qin gdao266021,China
Abstract
Background Implantable cardioverter-defibrillator(ICD)leads might not be extracted especially in developing countries becau of the high cost and lack of specialized tools.We aimed to evaluate transvenous extraction of ICD leads using optimized standard techniques. Methods We prospectively analyzed clinical characteristics,optimized extraction techniques and the feasibility of extraction for40patients (33males;mean age47.9±16.1years)with42ICD leads.Results Complete procedural success rate was95.2%(40/42),and the clinical success rate was97.6%(41/42).One ICD lead required cardiothoracic surgery.Minor complications occurred in three cas(7.5%),and no major complications or death occurred.Locking stylets were ud to extract most leads(34,81.0%)and almost half of the leads(20,47.6%) required mechanical dilatation to free fibrotic adhesions;the leads had been implanted for a longer period of time than the others(43.7±18.2vs.18.4±13.4months,P<0.05).Three-quarters of the leads(30,71.4%)were extracted with locking stylets plus manual traction(12, 28.6%),or mechanical dilatation with counter-traction(18,42.8%)by the superior vena cava approach and one-quarter of the leads(11, 26.2%)were removed by optimized snare techniques using the femoral vein approach.Median extraction time was20min(range2–68min) per lead.Linear regression analysis showed that the extraction time was significantly correlated with implant duration(r=0.70,P<0.001). Median follow-up was14.5months(range1–58months),no infection,or procedure-related death occurred in our ries.C
onclusions Our optimized procedure for transvenous extraction of ICD leads provides a practical and low-cost method for standard procedures.
J Geriatr Cardiol2013;10:39.doi:10.3969/j.issn.1671-5411.2013.01.002
Keywords:Lead;Extraction;Implantable cardioverter-defibrillator;Infection;Complications
1Introduction
The u of implantable cardioverter-defibrillator(ICD) leads has been exponentially increasing,and ICD lead extraction has become a necessary procedure.But ICD lead extraction has potentially rious complications,including venous or myocardial tear,cardiac tamponade,and even death.[1]Powered sheaths,such as Excimer lar or a radiofrequency system,have been ud for extraction of ICD or pacemaker leads.[2,3]However,the Heart Rhythm Society(HRS)has stated that“possible predictors of major Correspond ence to:Xue-Bin Li&Ji-Hong Guo,Department of Cardiac Electrophysiology,Peking University Peo ple's Hosp ital,No.11Xizhimen South St,Xicheng District,Beijing100044,China.E-mails:lixuebing_zb@ (Li XB);(Chu XM)
Telephone:+86-532-82913125Fax:+86-532-82913125
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Received:August21,2012Revid:Octob er13,2012 Accepted:Jan uary30,2013Pub lished online:March20,2013complications were implant duration of the oldest lead, female gender,ICD lead removal,and u of the lar extraction technique,multiple leads,and calcified leads.”[4,5] Conquently,u of powered sheaths may not be optimal.
In addition,powered sheath systems are not available in many countries,especially in developing countries such as China.Furthermore,the high cost prevents their widespread u.To investigate ICD lead extraction in China,we explored the feasibility of transvenous extraction of ICD leads by optimized standard techniques.In our practice, traditional traction,mechanical dilatation,counter-traction, and our innovative extraction methods were synergistic and optimized to dissociate and extract leads,or lead fragments, and may be uful and low cost for clinical practice.
2Methods
2.1Patient s
Extraction indications were HRS class I and IIa indica-
scapegoat
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tions:infection with a cardiovascular implantable electronic device(CIED)system or CIED pocket;valvular endocar-ditis without definite involvement of the lead(s)and/or device;occult Gram-positive bacteremia;and lead malfunc-tion.Exclusion criteria were HRS classⅢindications.[4,5] The study was approved by the audit department and Rearch Ethics Committee of Peking University People's Hospital.All subjects gave their informed connt,and patient anonymity has been prerved.
From January2006to July2012,more than580leads were extracted from280patients in our center.Leads were extracted becau of infection or lead malfunction.There were40patients with ICD leads,and data collected included patient demographics,type of device and leads,co-mor-bidities,reason for extraction,procedural information and complications,re-implantation,and outcome.
2.2Definit ions
Lead extraction,complete procedural success,clinical success,failure,and complications were defined according to the HRS recommendation.Complete procedural success was defined as removal of all targeted leads and lead material from the vascular space,with the abnce of any permanently disabling complication or procedure-related death.Clinical success was defined as removal of all targ
eted 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. Implant duration was the time between initial lead implantation to the time of extraction.Lead extraction time was duration from the time when the head of the lead was cut off to the time of complete removal.Device-related infective endocarditis was defined according to the modified Duke criteria.[6]Intracardiac vegetation was defined as a discrete,echogenic,oscillating mass found on a valve,lead, or endocardial surface and confirmed in multiple views by echocardiography.[5–8]
2.3Current protocol
culture是什么意思To prevent the potential risk of ptic embolization, pre-operative trans-esophageal echocardiography(TEE) was applied to stratify patients according to risk.Patients with infection and intracardiac vegetation reprented a high-risk population with multiple co-morbidities and significantly higher mortality rate regardless of management strategy.[9]Pacemaker dependency was checked for each patient before lead removal,and temporary pacing was ud when needed.After extraction,all patients underwent TEE before device reimplantation.Patients with infection received rial blood cultures and intravenous antibiotic therapy.[5–8]2.4Optimized standard techniques
Strategies were chon in a step-wi fashion.The superior vena cava approach was preferred.First,the ICD lead was discted,then manual traction was attempted,and the location of the binding tissue and adhesion extent along the lead was estimated by X-ray.Second,if lead removal failed,the lead was cut off,and a proper-sized locking stylet (Liberator Locking Stylet,Cook Medical,USA)was inrted along the lumen and locked at the distal part of the lead,then manual traction was attempted again.Third,if traction alone was still unsuccessful becau of adherent fibrotic tissue,a telescoping dilator polypropylene sheath (LR-PPLBES,Byrd Dilator Sheath Set,Cook Medical, USA)was inrted along the lead to disrupt fibrotic attachments until the lead was free of all binding tissue. Then,the sheath was connected to the endocardium,and counter-traction was ud to remove the lead.
If the lead was not accessible from the venous entry,the optimized snare methods by the femoral vein approach were applied.A ud and disinfected ablation catheter was typically applied to stretch leads to dissociate them from the vascular wall,endocardium,and/or valve.In some cas,if the lead floated in the right-ventricular and/or pulmonary artery,an ablation catheter was manipulated to and stretch the lead into the right atrium or vena cava.Then,a Gooneck Snare(Amplatz,USA)was inrted through a 6F Judkin right coronary catheter(Cordis,USA)to grasp and remove the lead or le
ad fragments.An ablation catheter could be ud with the Byrd Workstation Retrieval Set, Dotter Basket Snare and Tip-Deflecting Guide Wire(Cook Medical,USA)to snare the lead or lead fragments.
2.5St at istical analysis
Data were prented as mean±SD,median(interquartile range[IQR]),and/or number and percentage.The unpaired Student’s t-test or Mann-Whitney U test was ud to analyze the nonparametric data.Linear regression analysis was undertaken to asss the relationship between extraction time and implant duration.All the statistical analys were performed using SPSS17(SPSS Inc.,Chicago,IL)and P< 0.05was considered statistically significant.
3Results
3.1Baline clinical char acter istics
We extracted42ICD leads from the40patients(33 males;mean age47.9±16.1years).Patient demographics, indications for extraction(Figure1)and lead types were listed in Table1.Before visiting our center,29patients with
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infection had received enhanced antibiotic therapy(vanco-mycin,etc.);21patients with pocket infection underwent pocket debridement for one to six times without lead removal,then,the original ICD devices were reimplanted in 15patients after disinfection.New pockets or deep burying of original ICD devices under the pectoralis was tried.One patient with infective endocarditis underwent ICD replace-ment in another medical center despite recurrent fever and lead vegetation;repeated high fever and positive blood culture continued after replacement.Six ICD leads had been cut off and fixed to the chest muscle,but had retracted into the heart or vasculature,over time.All attempts of conrva-tive treatment failed.
Six patients with endocarditis have visible vegetation; two on the lead(0.8×0.5cm,0.6×1.0cm),one on the lead and tricuspid valve(1.8×1.4cm),one on the lead and the superior vena cava entry(0.5×1.2cm),and the other two on the tricuspid valve(1.0×1.6cm,0.5×1.4
computational mechanics
cm).
Figure1.Extraction indications.(A):Pocket infection;(B): Lead breakage under clavicle.
Table1.Baline clinical characteristics of patients(n=40)and implantable cardioverter-defibrillators(ICDs,n=42).
Ch ar acter istics
Male/female
Age,y r s(mean,r an ge)
Imp lantation ind ication
Brugada synd rome(ICD)
heyiL ong QT syndrome(ICD)
Cardiomyop athy(cardiac resynchron ization therapy defibrillator) Extr action ind ication
Infectio n
Pocket in fection
Endocarditis
Gram-p ositiv e bacteremia
Intracardiac vegetation,cm(mean±SD)
Lead break age or damage
Defibrillator lead
Single-coil/dual-coil
Coated/n on-coated lead
Active/passive fix ation lead
Imp lant d uration,mon ths(mean±SD,range)33(82.5%)/7(17.5%) 47.9±16.1(range26–85)
17(42.5%)
15(37.5%)
8(20.0%)
29(72.5%)
21(52.5%)
6(15.0%)
2(5.0%)
(0.9±0.4)×(1.0±0.7) 11±27.5,n=42
4(9.5%)/38(90.5%)
19(45.2%)/23(54.8%)
6(14.3%)/36(85.7%) 32.5±23.8(2–96)
3.2Char acter istics of ICD lead extr action
We ud specialized extraction equipment for all the42 ICD leads,including locking stylets,telescoping sheaths,or femoral extraction tools(Figure2).Locking stylets were ud for34ICD leads(81.0%),another six leads had fractured and prolapd into the heart before surgery,and the remaining two leads could not be inrted through by locking stylets due to the breakage.Twenty dual-coil leads (47.6%),including four coated and16non-coated leads, adhered to the wall of the vein,tricuspid,and/or myocar-dium(Figure3)and had much longer implant duration than the other ICD leads[43.7±18.2(range22–96)vs.18.4±13.4(range1–48)months,P<0.05].In the cas,telescoping dilator sheaths and counter-traction were ud to isolate the leads along the adherent strip organizations for removal.Optimized snare methods by the femoral approach were ud if the lead had been cut off and retracted into the heart chamber before surgery(n=6,14.3%),or could not be removed by the superior vena cava approach(n=6, 14.3%)due to large adherent tissues or disruption during surgery.
In total,complete procedural success rate was95.2% (40/42),and the clinical success rate was97.6%(41/42) (Figure2).One patient required cardiothoracic surgery after failed by the transvenous approach,the56-month lead was non-coated,passive-fixati on,dual-coil,and formed
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Figure 2.Implantable cardioverter-defibrillator lead-extrac-tion characteristics (leads,n =
42).
Figure 3.Extracted implantable cardioverter-defibrillator lead with adhesive myocardium.
vere adhesion with the superior vena cava,and there was a vegetation on the lead and the superior vena cava entry (0.5×1.2cm).In one patient (with a non-coated,passive-fixation,dual-coil lead for 47months),a small portion of the lead was retained,but did not negatively affect the outcome of the procedure.In total,30ICD leads (71.4%)were completely extracted with the u of locking stylets plus manual traction (12,28.6%),or mechanical dilatation plus counter-traction (18,42.8%)by the superior vena cava approach (Figure 4).Optimized snare techniques were successfully ud to remove 11leads (26.2%)by the femo-ral approach (Figure 5,Figure 6).In particular,six ICD leads (14.3%)were active fixation leads (screw-in leads).After being locked with locking stylets and with some applied tension,the leads rotated counter-clockwi and were successfully removed.For five leads,the active fixed spirals have not retracted back to the end of the
electrodes.
Figure 4.Superior vena cava approach.A female patient with pocket infection and dual-coil ICD lead (96months).(A):After the lead was locked with a locking stylet,a telescoping dilator sheath (black arrow)was advanced over the lead to free adhesions (polypropylene sheath was fuzzy on X-ray);(B):The sheath was advanced and connected to the endocardium,counter-traction was applied to remove the lead;(C):Extracted ICD and fibrotically encapsulated lead (white arrow).ICD:implantable
cardioverter-de-fibrillator.
The mean extraction time was 21.3±13.9min (range 2–68min)(median 20.0min,IQR 11.3–30.1min)per ICD lead.It was significantly longer for non-coated leads (n =22)than coated leads (n =19)(28.1±141min vs.12.6±6.6min,P =0.03).The extraction time was positively correla-ted with implant duration (r =0.70,P <0.001),and did not differ significantly between 6screw-in and 35passive-fixation leads [22.4±13.8min (range 2–38min)vs.20.8±15.8min (range 3–68min),P >0.05].3.3Complications
We found three cas (7.5%)with minor complications.Mild pulmonary embolism occurred in a patient with vege-tation (1.8×1.4cm)on the 56-month lead and tricuspid valve.Pneumothorax occurred in one female with lead breakage (96-month duration);the dual-coil lead had solidly adhered to the superior vena cava and subclavian vein.A locking stylet and telescoping dilator sheath were ud to remove the lead successfully,with lead extraction time of 20min.The chest X-ray revealed a left pneumothorax,which cured after clod thoracic drainage.One patient
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decision making
Figure 5.Superior vena cava approach and femoral vein approach(optimized snare technique).A male patient with pocket infection;one single-coil ICD lead(2months)and one dual-coil ICD lead(breakage under clavicle,black arrow)(28 months).(A):The single-coil lead was extracted successful by u of a locking stylet by the superior vena cava approach;however, the dual-coil ICD lead could not be removed becau of vere adhesion and breakage;(B&C):A Gooneck Snare(black arrow) and a Judkin right coronary catheter(white arrow)were inrted through a long16F sheath(Byrd Workstation,(black arrow))to grasp and extract the dual-coil lead;(D):The intact single-coil lead and fragments of the dual-coil lead.(pocket infection,60-month duration)had a small quantity of pericardial effusion after the procedure(extraction time 30min).
3.4Laboratory determination
Blood,pocket tissue and leads were cultured to arch for infectious pathogens.For29patients with infection,the pathogenic organisms were S taphylococcus aureus(n=12, 50.0%),S taphylococcus epidermidis(n=8,33.4%), Staphylococcus w arneri(n=2,8.3%)and Streptococcus viridians(n=2,8.3%).Causative organisms for six patients with infective endocarditis were Staphylococcus warneri(n =2),S treptococcus viridians(n=2)and Staphylococcus epidermidis(n=2).In the two patients with Gram-positive bacteremia,S taphylococcus epidermidis was isolated.For 21pati
ents with pocket infection,16had positive pocket tissue cultures,including methicillin-resistant Staphyloc-occus aureus in four patients,methicillin-nsitive Staphy-lococcus aureus in eight patients,and methicillin-nsitive Staphylococcus epidermidis in four patients.Blood cultures for all patients with pocket infection were negative.No lead fragment gave a positive result.
3.5Clinical follow-up
The mean follow-up was22.5±18.4months[range1–58 months,median14.5months(IQR7.3–41.8)].Three patients died due to cardiac sudden death,heart failure,or traffic accident.Recurrent fever decread within24h after extraction in patients with infection.In total,31patients (77.5%)underwent re-implantation with new devices during hospitalization at a median time of eight days
just a dream nellyafter Figure6.Optimized/innovative extraction techniques by femoral vein approach.(A):Standard snare with Dotter Basket Snare and
Tip-Deflecting Guidewire;(B&C):A ud and disinfected ablation catheter was adopted to twine,stretch and dissociate leads;(D-H):An blation catheter was ud with a16F sheath and Dotter Basket to remove leads.
a
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