Predicting the difficulty of a lead extraction procedure: the LED index.
BACKGROUND
According to recent surveys, many sites performing permanent lead extractions do not meet the minimum prerequisites concerning personnel training, procedures' volume, or facility requirements. The current Heart Rhythm Society consensus on lead extractions suggests that patients should be referred to more experienced sites when a better outcome could be achieved. The purpose of this study was to develop a score aimed at predicting the difficulty of a lead extraction procedure through the analysis of a high-volume center database. This score could help to discriminate patients who should be sent to a referral site.


METHODS
A total of 889 permanent leads were extracted from 469 patients. All procedures were performed from January 2009 to May 2012 by two expert electrophysiologists, at the University Hospital of Brescia. Factors influencing the difficulty of a procedure were assessed using a univariate and a multivariate logistic regression model. The fluoroscopy time of the procedure was taken as an index of difficulty. A Lead Extraction Difficulty (LED) score was defined, considering the strongest predictors.


RESULTS
Overall, 873 of 889 (98.2%) leads were completely removed. Major complications were reported in one patient (0.2%) who manifested cardiac tamponade. Minor complications occurred in six (1.3%) patients. No deaths occurred. Median fluoroscopic time was 8.7 min (3.3-17.3). A procedure was classified as difficult when fluoroscopy time was more than 31.2 min [90th percentile (PCTL)].At a univariate analysis, the number of extracted leads and years from implant were significantly associated with an increased risk of fluoroscopy time above 90th PCTL [odds ratio (OR) 1.51, 95% confidence interval (CI) 1.08-2.11, P = 0.01; and OR 1.19, 95% CI 1.12-1.25, P < 0.001, respectively). After adjusting for patient age and sex, and combining with other covariates potentially influencing the extraction procedure, a multivariate analysis confirmed a 71% increased risk of fluoroscopy time above 90th PCTL for each additional lead extracted (OR 1.71, 95% CI 1.06-2.77, P = 0.028) and a 23% increased risk for each year of lead age (OR 1.23, 95% CI 1.15-1.31, P < 0.001). Further nonindependent factors increasing the risk were the presence of active fixation leads and dual-coil implantable cardiac defibrillator leads. Conversely, vegetations significantly favored lead extraction.The LED score was defined as: number of extracted leads within a procedure + lead age (years from implant) + 1 if dual-coil - 1 if vegetation. The LED score independently predicted complex procedure (with fluoroscopic time >90th PCTL) both at univariate and multivariate analysis. A receiver-operating characteristic analysis showed an area under the curve of 0.81. A LED score greater than 10 could predict fluoroscopy time above 90th PCTL with a sensitivity of 78.3% and a specificity of 76.7%.


CONCLUSIONS
The LED score is easy to compute and potentially predicts fluoroscopy time above 90th PCTL with a relatively high accuracy.
aDivision of Cardiology, Civil Hospital and University, Brescia bBiotronik Italia Spa, Vimodrone, Milan, Italy cCardiovascular Department, Hospital Oil Workers, Baku, Azerbaijan.
Luca
L
Bontempi
Francesca
F
Vassanelli
Manuel
M
Cerini
Antonio
A
D'Aloia
Enrico
E
Vizzardi
Alessio
A
Gargaro
Francesco
F
Chiusso
Rashad
R
Mamedouv
Alessandro
A
Lipari
Antonio
A
Curnis
D000368:Aged; D000369:Aged, 80 and over; D002983:Clinical Competence; D017147:Defibrillators, Implantable; D020878:Device Removal / Q000009:adverse effects / Q000379:methods*; D004567:Electrodes, Implanted; D005260:Female; D005471:Fluoroscopy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial; D011379:Prognosis; D018570:Risk Assessment / Q000379:methods; D013997:Time Factors