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Heart Rhythm. 2014 Sep;11(9):1613-8. doi: 10.1016/j.hrthm.2014.05.014. Epub 2014 May 20.

Multicenter experience with extraction of the Riata/Riata ST ICD lead.

Author information

1
Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: mmaytin@partners.org.
2
Cleveland Clinic, Cleveland, Ohio.
3
Ohio State University Medical Center, Columbus, Ohio.
4
University Hospital, Pisa, Italy.
5
University of Miami Miller School of Medicine, Miami, Florida.
6
Drexel University College of Medicine, Philadelphia, Pennsylvania.
7
Mount Sinai School of Medicine, New York, New York.
8
University of Pittsburgh Medical College, Pittsburgh, Pennsylvania.
9
The Valley Health System and Columbia University College of Physicians and Surgeons, New York, New York.
10
Oregon Health & Science University, Portland, Oregon.
11
Scripps Green Hospital, El Cajon, California.
12
Brigham and Women's Hospital, Boston, Massachusetts.

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.

KEYWORDS:

ICD; Lead extraction; Lead management

PMID:
24854215
DOI:
10.1016/j.hrthm.2014.05.014
[Indexed for MEDLINE]
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