Abstract
Background In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial. Objective Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited. Methods We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers. Results Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84%]; Riata ST 89, [16%]). Complete procedural success achieved in 99.1%. The cohort was 78% men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34% ± 14%. The mean implant duration was 44.7 months (range 0-124.6 months). The majority of leads extracted were for infection (305 [53.0%]) and 220 (35.7%) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9% were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P <.0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7% vs 17.7% failure; P =.23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P =.01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%). Conclusion Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.
| Original language | English |
|---|---|
| Pages (from-to) | 1613-1618 |
| Number of pages | 6 |
| Journal | Heart Rhythm |
| Volume | 11 |
| Issue number | 9 |
| DOIs | |
| State | Published - Jan 1 2014 |
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Keywords
- ICD
- Lead extraction
- Lead management
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
- Physiology (medical)
Cite this
Multicenter experience with extraction of the Riata/Riata ST ICD lead. / Maytin, Melanie; Wilkoff, Bruce L.; Brunner, Michael; Cronin, Edmond; Love, Charles J.; Grazia Bongiorni, Maria; Segreti, Luca; Carrillo, Roger; Garisto, Juan D.; Kutalek, Steven; Subzposh, Faiz; Fischer, Avi; Coffey, James O.; Gangireddy, Sandeep R.; Saba, Samir; Mittal, Suneet; Arshad, Aysha; O'Keefe, Ryan Michael; Henrikson, Charles A.; Belott, Peter; John, Roy M.; Epstein, Laurence M.
In: Heart Rhythm, Vol. 11, No. 9, 01.01.2014, p. 1613-1618.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Multicenter experience with extraction of the Riata/Riata ST ICD lead
AU - Maytin, Melanie
AU - Wilkoff, Bruce L.
AU - Brunner, Michael
AU - Cronin, Edmond
AU - Love, Charles J.
AU - Grazia Bongiorni, Maria
AU - Segreti, Luca
AU - Carrillo, Roger
AU - Garisto, Juan D.
AU - Kutalek, Steven
AU - Subzposh, Faiz
AU - Fischer, Avi
AU - Coffey, James O.
AU - Gangireddy, Sandeep R.
AU - Saba, Samir
AU - Mittal, Suneet
AU - Arshad, Aysha
AU - O'Keefe, Ryan Michael
AU - Henrikson, Charles A.
AU - Belott, Peter
AU - John, Roy M.
AU - Epstein, Laurence M.
PY - 2014/1/1
Y1 - 2014/1/1
N2 - Background In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial. Objective Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited. Methods We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers. Results Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84%]; Riata ST 89, [16%]). Complete procedural success achieved in 99.1%. The cohort was 78% men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34% ± 14%. The mean implant duration was 44.7 months (range 0-124.6 months). The majority of leads extracted were for infection (305 [53.0%]) and 220 (35.7%) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9% were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P <.0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7% vs 17.7% failure; P =.23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P =.01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%). Conclusion Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.
AB - Background In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial. Objective Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited. Methods We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers. Results Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84%]; Riata ST 89, [16%]). Complete procedural success achieved in 99.1%. The cohort was 78% men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34% ± 14%. The mean implant duration was 44.7 months (range 0-124.6 months). The majority of leads extracted were for infection (305 [53.0%]) and 220 (35.7%) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9% were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P <.0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7% vs 17.7% failure; P =.23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P =.01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%). Conclusion Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.
KW - ICD
KW - Lead extraction
KW - Lead management
UR - http://www.scopus.com/inward/record.url?scp=84906716488&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84906716488&partnerID=8YFLogxK
U2 - 10.1016/j.hrthm.2014.05.014
DO - 10.1016/j.hrthm.2014.05.014
M3 - Article
C2 - 24854215
AN - SCOPUS:84906716488
VL - 11
SP - 1613
EP - 1618
JO - Heart Rhythm
JF - Heart Rhythm
SN - 1547-5271
IS - 9
ER -