PISA, ITALY — Transvenous lead extraction (TLE) of cardiac implantable electronic devices has an acceptable risk/benefit ratio in clinical practice, but with potentially life-threatening complications, according to the prospective European Lead Extraction Controlled Registry (ELECTRA)[1].
The study also identified that femoral access was associated with a higher rate of procedure-related major complications (4.09%), either as the primary (9.09%) or secondary (3.46%) approach, when compared with other approaches (1.43%, P=0.002).
In multivariate analyses, a femoral approach more than tripled the risk of procedure-related major complications including death (odds ratio 3.60, 95% CI 1.64–7.87) and clinical failure (OR 3.93, 95% CI 2.23–6.92).
"This novel finding that femoral access was less safe in comparison with other approaches still warrants some precautions regarding choice of environmental facility, operator experience, and risk profile of the patient to minimize the risk for complications," lead author Dr Maria Grazia Bongiorni (University Hospital of Pisa, Italy) and her colleagues reported recently in the European Heart Journal.
Other independent predictors of procedure-related major complications including death were female sex (OR 2.11, 95% CI 1.23–3.62), lead dwell time >10 years (OR 3.54, 95% CI 1.60–7.83), and use of powered sheaths alone (OR 2.40, 95% CI 1.41–4.09).
Independent predictors of clinical failure were:
Female sex (OR 1.81, 95% CI 1.21–2.73).
>3 extracted leads (OR 2.47, 95% CI 1.62–3.76).
Lead dwell time >10 years (OR 4.00, 95% CI 2.20–7.26).
Powered sheaths alone (OR 1.89, 95% CI 1.25–2.86).
Low-volume centers (OR 2.23, 95% CI 1.46–3.42).
ELECTRA Design
The study, described as the largest reflection of current TLE practice, enrolled 3555 consecutive patients (mean age 64.8 years; 72% male), of whom 3510 underwent TLE at 73 centers in 19 European countries from November 1, 2012 to May 30, 2014.
A total of 6493 leads, including 4917 pacing and 1576 ICD leads, were targeted for extraction. The mean dwell time of extracted leads was 6.4 years and mean number of leads extracted per case 1.8. The most common indication for lead removal was device infection, with a rate of 52.8%, and which was systemic in about 19% and local in 33% of the cohort.
The primary end point of procedure-related major complications occurred in 58 patients (1.7%), including death in 17 (0.5%). Nine of the deaths were intraprocedural and eight postprocedural.
Two-thirds of major complications occurred during the procedure itself, most frequently due cardiac avulsion or thoracic vascular lesions, in 28 and 15 patients, respectively.
Of the 47 patients who underwent therapeutic intervention for a major complication, 37 survived. Mortality related to cardiovascular complications occurred in 12 patients (0.3%). Two patients died without intervention, including one patient who had a peripheral vessel lesion diagnosed late with bleeding after a femoral approach.
Independent predictors of all-cause mortality were:
Low-volume centers (OR 2.02, 95% CI 1.07–3.81).
Age >68 years (OR 2.42, 95% CI 1.26–4.66).
NYHA class 3–4 (OR 4.08, 95% CI 2.24–7.43).
Systemic infection (OR 4.93, 95% CI 2.72–8.93).
High- vs Low-Volume Centers
The investigators also examined the impact of procedural center volume on outcomes using an "arbitrary cutoff" of >30 cases per center per year, based on previous consensus statements regarding center experience and training. High-volume centers enrolled a median of 43 patients/year (range 30–218) vs 22 patients/year at low-volume centers (range 12–29).
Despite the patients having similar lead dwell times and number of leads extracted, high-volume centers were significantly more likely to achieve radiological (P<0.0001) and clinical (P=0.0001) success than low-volume centers.
They also had lower all-cause in-hospital major complications (2.4% vs 4.1%, P=0.014) and death rates (1.2% vs 2.5%, P=0.008) than low-volume centers.
This finding "suggests that the outcome of TLE not only is confined to the TLE procedure per se but is dependent on multiple patient factors and comorbidities that require an advanced and highly skilled multidisciplinary team management that may be facilitated only in [high-volume] centers," Bongiorni and colleagues write.
While the ELECTRA registry confirmed the inverse relation between major complications and procedural center volume, the investigators note that as this was not the primary end point of the study they "cannot clearly define the appropriate number of procedures per center per year to minimize the complications related to the procedure."
Finally, lead extractions in high-volume centers were associated with a shorter procedure duration and significantly shorter hospital stay than at low-volume centers (6.0 vs 8.4 days; P<0.0001), which "may also have important financial implications," they added.
The study was supported by Boston Scientific, Cook Medical, Medtronic, Spectranetics, and Zoll. Bongiorni reports grants from Boston Scientific, Medtronic, St Jude Medical, and Biosense Webster. Disclosures for the coauthors are listed in the paper.
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Heartwire from Medscape © 2017
Cite this: Real-world Registry IDs Highs, Lows of Device Lead Extraction - Medscape - Apr 20, 2017.
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