Transvenous Lead Extraction without Procedure-Related Deaths in 1000 Consecutive Patients: A Single-Center Experience

Figures & data

Figure 1 (A) Hybrid operating room. In the background a table with surgical instruments designed for sternotomy. (B) Cardiac surgical and anesthesia team and an echocardiographer performing TEE monitoring (C) Removed leads. Thick fibrotic tissue with calcific changes around the leads, and a variety of damage to outer silicone tube (mechanical damage during extraction and an old abrasion – dark color of the distal end of the lead). (D) “After the battle”. The tools used for lead extraction: conventional mechanical non-powered sheaths (Byrd polypropylene sheaths, Cook) in three sizes and mechanical rotational threaded sheaths - Evolution (Cook) – two sizes.

Figure 2 Transvenous extraction of an atrial lead was complicated by right atrial appendage rupture and cardiac tamponade requiring urgent cardiac repair. (A) Fluoroscopy. Atrial lead removal, the tip of the sheath marked with an arrow. (B) 2D TEE images (mid-esophageal view). The winding and pulling on the right atrial appendage (RAA) during extraction of the atrial lead. These potentially harmful effects are not visible on fluoroscopy. The sheath marked with an arrow. (C) 2D TEE images (transgastric view). Separation of pericardial layers – blood – immediately after removal of the lead. (D) Extracted leads on the table. Thick fibrotic encapsulation, partly calcified around the leads. Small abrasion of the external tube with perforation of the atrial lead – less visible. Fluid in the lead in this area. (E) Intraoperative view – RAA rupture/injury.

Table 1 Patient Demographic and Clinical Data, Pacing System Data, Indications for TLE

General Patient Information	No/Range	Mean±SD/%
Patient age during TLE [year]	18–99	67.32±14.34
NYHA III or IV (n)	154	15.4%
LVEF < 40% (n)	380	38.0%
Permanent AF [yes/no]	235	23.5%
Heart failure symptomatic (n)	288	28.8%
Previous sternotomy (n)	143	14.3%
Valvular implant (n)	89	8.9%
Long-term anticoagulation (n)	420	42.0%
Long-term antiplatelet treatment (n)	462	46.2%
Diabetes (any) (n)	203	20.3%
Renal failure (any) (n)	260	26.0%
Charlson’s index [points]	0–16	4.87±3.69
Main TLE Indications	No	(%)
Systemic infection (n)	159	15.9%
Local (pocket) infection (n)	63	6.3%
Mechanical Lead Damage (electric failure) (n)	305	30.5%
Lead dysfunction caused by (usually dry) perforation	136	13.6%
Lead dysfunction (exit/entry block, dislodgement, extracardiac pacing) (n)	135	13.5%
Change of pacing mode/ upgrading, downgrading (n)	62	6.2%
Restored Venous Access (symptomatic occlusion, SVC syndrome, lead replacement/upgrading) (n)	45	4.5%
Threatening/potentially threatening lead (loops of the leads, free ending, left heart, LDTD (n)	35	3.5%
Other (MRI indication, cancer, pain of pocket, loss of indication for pacing/ICD) (n)	34	3.4%
Abandoned lead/prevention of abandonment (AF, redundant leads) (n)	26	2.6%
All (n)	1000	100.0%
System before TLE procedure	No	(%), mean±SD
AAI (n)	72	7.2%
DDD	460	46.0%
VDD (n)	20	2.0%
VVI (n)	95	9.5%
CRT-P (n)	27	2.7%
ICD-V (n)	129	12.9%
ICD-D (n)	95	9.5%
CRT-D (n)	98	9.8%
PM lead, unit removed earlier (n)	1	0.1%
ICD lead, unit removed earlier (n)	3	0.3%
Lead dwell time of oldest lead in the patient before TLE [months]	1–468	112.9±77.40
Sum of lead dwell times in the patient before TLE [years]	1–104	17.31±14.13

Abbreviations: AAI, single chamber atrial pacing system; AF, atrial fibrillation; CRT-D, cardiac resynchronization therapy-defibrillator; CRT-P, cardiac resynchronization therapy-pacemaker; ICD, implantable cardioverter-defibrillator dual chamber; ICD-V, implantable cardioverter-defibrillator single chamber; LDTD, lead-dependent tricuspid dysfunction; LVEF, left ventricular ejection fraction; MRI, magnetic resonance imaging; NYHA, New York Heart Association class; PM, pacemaker; SVC, superior vena cava; TLE, transvenous lead extraction; VVI, single chamber ventricular pacing system; VDD, dual chamber pacing system without atrial pacing.

Table 2 Lead Management and Organization of TLE Procedure

General Procedure Information	No/Range	Mean±SD/%
Main goal of TLE
Infectious indications	222	22.2%
Lead replacement	515	51.5%
Up-grading of the system	138	13.8%
Down-grading of the system	54	5.4%
Superfluous lead extraction	47	4.7%
System removal - reimplantation deferred	13	1.3%
Redundant system removal	11	1.1%
All	1000	100.0%
General options of lead management
Extraction of all leads	770	77.0%
Functional lead was left for continuous use	227	22.7%
Non-functional, superfluous lead was extracted	91	9.1%
Non-functional lead was left	1	0.1%
Presence of abandoned lead before TLE
Presence of abandoned lead	93	9.3%
Number of abandoned leads	0–3	0.12±0.39
Extraction of abandoned lead
Extraction of abandoned lead (number of patients)	91	9.1%
1 abandoned lead was extracted	71	7.1%
2 abandoned leads were extracted	18	1.8%
3 abandoned leads were extracted	2	0.2%
Abandoned lead was left	1	0.1%
Organizational model of TLE procedure. The role of cardiac surgeon, TEE and general anesthesia
Cardiac surgeon as a co-operator in hybrid room	504	50.4%
Cardiac surgeon as a co-operator in hybrid room without TEE	58	5.8%
Cardiac surgeon as a co-operator in operating (cardiac surgery) room	406	40.6%
Cardiac surgeon as a co-operator in operating (cardiac surgery) room without TEE	32	3.2%
All	1000	100.0%

Table 3 TLE Procedure Information

Procedure Information	No/Range	Mean±SD/%
Oldest extracted lead dwell time [months]	1–468	111.7±76.99
Sum of dwell times of extracted leads (global age of extracted leads) [years]	1–104	15.6 ±14.1
Procedure duration (skin-skin time) [minute]	31–330	63.03±27.17
Procedure duration (sheath-sheath time) [minute]	1–300	15.44±24.38
Average time of single lead extraction [minutes]	1–240	9.0±14.3
Venous obstruction/occlusion n (%)	118	11.8%
Dependence on the pacemaker	234	23.4%
1 lead was extracted	480	48.0%
2 leads were extracted	405	40.5%
3 leads were extracted	99	9.9%
4 leads were extracted	15	1.5%
5 leads were extracted	1	0.1%
Selected approach
Left subclavian approach	963	96.3%
Right subclavian approach	20	2.0%
Both	8	0.8%
Subclavian+femoral approach	4	0.4%
Other combined approach	2	0.2%
Jugular approach only	1	0.1%
Cardiac surgery. Lead remnant removal during rescue intervention	2	0.2%
All	1000	100.0%
Extraction of “challenging/ terrible leads”
Extraction of VDD lead	23	2.3%
Extraction of lead with proximal ending in cardiovascular system	5	0.6%
Extraction of ICD lead	298	29.8%
Extraction of CS branch lead for LV pacing	73	7.3%
Extraction of CS, CSO leads for LA pacing	51	5.1%
Procedure complexity - “technical problems”
Any technical complication	250	25.0%
Block in subclavian venous entry	118	11.8%
Byrd dilator collapse/twist	52	5.2%
Lead to lead fibrotic adherence	98	9.8%
Fracture of the extracted lead	58	5.8%
Necessity to change approach	17	1.7%
Loss of broken lead fragment	6	0.6%
Dislodgement of functional lead	10	1.0%
1 technical problem	140	14.0%
2 technical problems	50	5.0%
3 technical problems	15	1.5%
4 technical problems	6	0.6%
5 technical problems	1	0.1%
6 technical problems	1	0.1%
Unrolling ICD lead coil with dilating sheath	15	1.5%
No technical complications	788	78.8%
Necessity to use rotational mechanical sheath (Evolution or TightRail)	25	2.5%
Necessity to use metal sheath	113	11.3%
Necessity to use lasso catheter	41	4.1%
Use of lasso and guide wire loop	15	1.5%

Abbreviations: CS, coronary sinus; CSO, coronary sinus ostium; ICD, implantable cardioverter-defibrillator; LA, left atrium; LV, left ventricle; VDD, dual chamber pacing system without atrial pacing.

Table 4 Effectiveness of Lead Extraction Expressed as Radiographic, Clinical and Procedural Success, Major and Minor Complications in 1000 Procedures

TLE Effectiveness	No
Complete procedural success “with the absence of any permanently disabling complication”
Success	945
Success but rescue cardiac surgery	13
Success explorative sternotomy	1
No, retained lead tip	10
No, retained lead fragment	24
No, significant tricuspid valve damage	7
All	1000
Clinical success „with the absence of any permanently disabling complication”
Success	976
Success but rescue cardiac surgery	14
Success explorative sternotomy	1
No, retained lead tip, infectious indication	2
No, significant tricuspid valve damage	7
All	1000
Major complications
Absent	978
Hemopericardium - cardiac surgery	13
Hemothorax - cardiac surgery	1
Acute heart failure	1
Tricuspid valve damage - significant	7
All	1000
Rescue (acute) cardiac surgery
RA suture (damaged during V lead extr.)	1
Vena cava suture	1
RA suture (damaged during atrial lead extr.)	10
RV suture	1
Numerous/Complex sutures (RA, CS)	1
Acute Tricuspid Valve Repair	1
Explorative sternotomy	1
Extracorporeal circulation during rescue cardiac surgery	3
All acute surgical interventions	16
Minor complications during TLE
Worsening tricuspid valve function	40
Bleeding requiring blood transfusion	18
Hematoma requiring evacuation	12
Pericardial effusion without surgical intervention	10
Migrated lead fragment without sequelae	0
Venous thrombosis requiring medical intervention	4
Pneumothorax requiring chest tube	3
Pulmonary embolism	0
All patients with minor complications	92
Long-term survival after TLE procedure
Periprocedural-related death	0
7-day mortality	3
30-day mortality	13
6-month mortality	41
All follow-up mortality	147
All	1000

Abbreviations: CS, coronary sinus; RA, right atrium.

Table 5 Major Complications of TLE in Patients with Lead Implant Duration of Less Than 10 Years

Age of Oldest Extracted lead [in Months]	Safety TLE Score^Citation15	Major Complication	Acute Surgical Intervention	Planned Delayed Surgical Intervention
385	17.9	Tricuspid valve damage		Tricuspid valve repair
363	16.6	Hemopericardium - surgery	RA suture
348	24.8	Hemopericardium - surgery	RA suture
324	17.9	Hemopericardium - surgery	RA suture
300	16.6	Tricuspid valve damage
278	14.3	Hemopericardium - surgery	RA suture
245	15.2	Hemopericardium - surgery	RA suture
226	15.2	Hemopericardium - surgery	RA suture
223	10.2	Tricuspid valve damage		Tricuspid valve repair
219	11.1	Hemopericardium - surgery	RA suture
204	13.9	Hemopericardium - surgery	RA suture
182	11.6	Hemopericardium - surgery
144	5.8	Tricuspid valve damage		Tricuspid valve repair
143	13.9	Hemopericardium - surgery	RA suture
135	13.9	Tricuspid valve damage		Refused TV repair
132	7.8	Hemopericardium - surgery	RV suture
119	3.7	Hemopericardium - surgery	RA suture
112	7.8	Hemopericardium - surgery	RA suture
108	8.8	Tricuspid valve damage		Borderline indications -observation
97	5.0	Tricuspid valve damage		Disqualification, cancer disease
69	6.4	Hemothorax - surgery	VCS suture
50	6.4	Acute heart failure, suspected VCS tear	Explorative sternotomy

Table 6 List of Publications Describing Effectiveness and Safety of TLE Procedures

Reference Number	Author, Journal, Year	Type of Study	Number of pts	Methods of TLE (Predominant, First Line Tool)	Mean Dwell Time (Months)	% of infectious Indications	Procedural/Clinical Success (PS)/(CS)	Major Complications (%)	Procedure Related Death (%)
1	Byrd CL Pacing Clin Electrophysiol 1999	US Extraction Database analysis	2338	Mech dilat	47	27.00%	PS 93%	1.40%	0.40%
3	Bongiorni M Eur Heart J. 2008	Single-center study	1193	Mech dilat	69	82.00%	PS 98.4%	0.70%	0.30%
5	Kennergren C Europace 2009	Single- center study	647	Laser 60%	91	58.00%	CS 97.6%	0.90%	0.00%
6	JACC Wazani O JACC 2010	LEXICon Sudy	1449	Laser sheath	82	57.00%	PS 96.5%	1.40%	0.30%
7	Gomes S Europace 2014	Single- center study	510	Mech dilat	47	65.00%	PS 96%	0.30%	0.20%
9	Maytin M CAE 2012	Single- center study	985	Laser 58%	72	50.00%	PS 99, CS 95%	0.60%	0.00%
10	Brunner MP Heart Rhythm 2014	Single- center study	2999	Laser 70%	61	43.00%	PS 95.1%	1.80%	0.20%
11	Fu HX Pacing Clin Electrophysiol 2015	Single- center study	652	Laser 51%	57	59.00%	PS 96.6%	2.01%	0.30%
13	El-Chami MF Heart Rhythm 2015	Single- center study	462	Laser 45%	55	15.00%	PS 98% CS 98%	1.30%	0.65%
14	2015 Merchant FM (Atlanta)	Single- center study	508	Laser 57%, Mech dilat 8%	61	32.50%	PS 96.5%	1.60%	1.10%
15	2016 Gomes S Pacing Clin Electrophysiol (Sydney)	Single- center study	510	Mech dilat	47	74.00%	PS 92%, CS 98.2	0.20%	0.20%
16	2016 Bashir J Circ Arrhythm Electrophysiol	The British Columbia Cardiac Registry	1082	Laser	129	45.00%	???	3.00%	0.37%
17	2017 Barakat AF Heart Rhythm	Single- center study	503	Laser 62% Evol 9%	57	0.00%	PS 96.6% CS 97.2%	1.00%	0.40%
18	Hussein AA JACC Clin Electrophysiol 2017	Single- center study	1836	Laser, Mech Rotat	108	100.00%	PS 94.2 CS 95.1%	1.93%	0.29%
19	Kutarski A Europace 2017	Single- center study	2049	Mech dilat 97%	89	40.00%	PS 95.0% CS 97.9	1.80%	0.36%
20	Bongiorni M Eur Heart Journal 2017	The European Lead Extraction ConTRolled Registry (ELECTRa)	3555	Laser 19.3%	77	52.00%	CS 96.7%	1.70%	0.50%
21	Sood N Circ Arrhythm Electrophysiol 2018	Multicenter register	11,304	Laser 63%	65	14.00%	PS 97%	2.30%	0.16%
23	Sharma S JACC Clin Electrophysiol 2018	Single- center study	400	Mech Rotat	81	54.00%	PS 97.0,CS 99.7%	1.50%	0.00%
26	Gould J Pacing Clin Electrophysiol 2019	Single- center study	925	Laser 56%	85	54.60%	CS 98.5%	1.60%	0.30%
27	Jacheć W Pacing Clin Electrophysiol 2019	Two-center study	3810	Mech dilat 98%	86	46.10%	PS 94.6% CS 97.6%	1.44%	0.17%
29	Segreti L Europace 2020	Single- center study	1210	Mech dilat	72	67.00%	CS 96%	0.70%	0.16%
31	Starck CT Europace 2020	Multicenter study (PROMET)	2205	Mech Rotat	74	46.00%	PS 97%, CS 96%	1.00%	0.18%
32	Giannotti Santoro M, Pacing Clin Electrophysiol 2020	Single- center study	1316	Mech dilat	72	65.70%	CS 97%	0.70%	0.00%
33	Zhou X Heart Vessels 2020	Single- center study	492	Needle’s Eye Snare	113	91.00%	PS 94%,CS 98%	1.90%	0.20%
33	Stefańczyk P This paper 2021	Single-center study	1000	Mech dilat 98%	112	22.00%	CS 99.1, PS 95.9	2.20%	0.00%
	ALL studies		43,940		74.51	41.71%		1.67%	0.24%

Notes: Mech dilatation: Cook’s extraction kit as locking stylets, dilator sheaths, and/or transfemorally used snares, retrieval baskets, and sheaths and if necessary other tools. Mech Rotational: Evolution, TightRail.

Abbreviations: PS, complete procedural success; CS, clinical success.

Bongiorni MG, Kennergren C, Butter C, et al., ELECTRa Investigators. The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) registry of transvenous lead extraction outcomes. Eur Heart J. 2017;38:2995–3005.

 PubMed Web of Science ®Google Scholar