Date Published: April 29, 2019
Publisher: Public Library of Science
Author(s): Arwa Younis, Michael Glikson, Amit Meitus, Noga Arwas, Sharon Shalom Natanzon, Dor Lotan, David Luria, Roy Beinart, Eyal Nof, Tomohiko Ai.
Cardiac implantable electronic device (CIED) trans venous lead extraction (TLE) is technically challenging. Whether the use of a laser sheath reduces complications and improves outcomes is still in debate. We therefore aimed at comparing our experience with and without laser in a large referral center.
Information of all patients undergoing TLE was collected prospectively. We retrospectively compared procedural outcomes prior to the introduction of the laser sheath lead extraction technique to use of laser sheath.
During the years 2007–2017, there were 850 attempted lead removals in 407 pts. Of them, 339 (83%) were extracted due to infection, device upgrade/lead malfunction in 42 (10%) cases, and other (7%). Complete removal (radiological success) of all leads was achieved in (88%). Partial removal was achieved in another 6% of the patients. Comparison of cases prior to and after laser technique introduction, showed that with laser, a significantly smaller proportion of cases required conversion to femoral approach [31/275 (6%) laser vs. 40/132 (15%) non-laser; p<0.001]. However, success rates of removal [259/275 (94%) vs. 124/132 (94%) respectively; p = 0.83] and total complication rates [35 (13%) vs. 19 (14%) respectively; p = 0.86] did not differ prior to and after laser use. In multivariate analysis, laser-assisted extraction was an independent predictor for no need for femoral extraction (OR = 0.39; 95% CI 0.23–0.69; p = 0.01). Introduction of laser lead removal resulted in decreased need to convert to femoral approach, albeit without improving success rates or preventing major complications.
With the steady increase in the population life expectancy and the progress in medical knowledge and technology, the number of CIEDs (cardiovascular implantable electronic devices) implanted continues to rise worldwide [1, 2]. This results in an increase need for lead extraction above and beyond the rise in implantations [1, 3]. Leads are extracted due to infection, malfunction, venous stenosis, occlusion, need for device upgrade and more .
The main finding of our study is that the use of laser significantly reduced the need to convert to femoral approach during the procedure without increasing the complication rates. However the overall procedural success did not improve with laser.
The main limitation of our study is the non-randomized design. There are some significant differences in the characteristics of the patients and the indications for the procedure. These differences are e secondary to expanding the indications for the extraction (i.e. older patients with more comorbidities). However in a multivariable analysis the use of laser was still the only predictive variable. This can be found in Table 4. The design of the study cannot eliminate the fact that the ability to crossover to another sheath may have biased the results. However, since we used the same stepwise approach in all patients during each period, we assume that this bias was low. Our relative low number of patients with complication resulted in difficulties concluding statistical significance. We assume that for evaluating the differences in complication rates, a larger sample size is needed.
In our high volume center, introduction of laser lead removal resulted in lesser need to convert to femoral approach, albeit without improving success rates or preventing major complications.