Based on the published results primarily from cohort studies, percutaneous lead extraction is now considered a safe procedure and indications for its use have broadened from device-related infections to less strict indications, such as recurrent isolated bacteremia, asymptomatic upper vein occlusion and malfunctioning/redundant leads. Almost 50% of electrophysiologists consider lead extraction in these latter situations. To broaden its implementation, further prospective evaluation against conservative approaches is still needed. Rather than only aiming at short-term results, this technique should be integrated into wide-ranging tailored long-term strategies to manage all of the different issues of implanted patients.
1 December 2017 in International Journal of Cardiology
(1) Background: Leadless (LL) stimulation is perceived to lower surgical, vascular, and lead-related complications compared to transvenous (TV) pacemakers, yet controlled studies are lacking and real-life experience is non-conclusive. (2) Aim: To prospectively analyse survival and complication rates in leadless versus transvenous VVIR pacemakers. (3) Methods: Prospective analysis of mortality and complications in 344 consecutive VVIR TV and LL pacemaker recipients between June 2015 and May 2021. Indications for VVIR pacing were “slow” AF, atrio-ventricular block in AF or in sinus rhythm in bedridden cognitively impaired patients. LL indication was based on individualised clinical judgement. (4) Results: 72 patients received LL and 272 TV VVIR pacemakers. LL pacemaker indications included ongoing/expected chronic haemodialysis, superior venous access issues, active lifestyle with low pacing percentage expected, frailty causing high bleeding/infectious risk, previous valvular endocarditis, or device infection requiring extraction. No significant difference in the overall acute and long-term complication rate was observed between LL and TV cohorts, with greater mortality occurring in TV due to selection of older patients. (5) Conclusions: Given the low complication rate and life expectancy in this contemporary VVIR cohort, extending LL indications to all VVIR candidates is unlikely to provide clear-cut benefits. Considering the higher costs of LL technology, careful patient selection is mandatory for LL PMs to become advantageous, i.e., in the presence of vascular access issues, high bleeding/infectious risk, and long life expectancy, rendering lead-related issues and repeated surgery relevant in the long-term perspective.
Left ventricular active fixation lead is fundamental for targeted pacing site. The challenge is the extraction but in our experience Attain(®) Stability™ was removed without any problem. As usual the lead can cause a thrombosis of the coronary vein but we performed a venoplasty in order to place again a lead in the target site and maintain the CRT response.
27 June 2011 in International Journal of Technology Assessment in Health Care
Background: We calculated the daily cost of implantable cardioverter-defibrillators (ICDs) based on their actual longevity to prove whether the up-front cost is a reliable parameter for the ICD purchasing-process.Methods. Longevity of single chamber (SC), double chamber (DC), and biventricular (BiV) ICDs from Medtronic (MDT), Guidant (GDT), and St. Jude Medical (SJM) was measured in all the patients implanted in years 2000, 2001, 2002 who reached device replacement within December 31, 2009. The cost of each ICD (device + lead/s) was normalized for its own longevity. Data are expressed as median (25th–75th percentile).Results: A total of 123/153 patients completed the study, 70 percent being alive 8 years after implantation. MDT devices had a superior longevity compared with GDT and SJM (p < .001). Fifty-eight percent of replaced ICDs had a service life at least 1 year shorter than the manufacturers' prediction. Longer-lasting devices had a significantly lower daily cost: €4.8 (4.6–5.7) versus €6.8 (6.2–9.2) and €6.9 (6.2–7.6) for SC (p < .001); €6.9 (6.8–7.7) versus €12.6 (11.8–13.3) and €13.4 (10.3–16.1) for DC; €8.5 (8.3–10.3) versus €15.4 (15.1–15.8) and €14.6 (14.1–14.9) for BiV (p < .005).Conclusions: The true cost of ICD treatment is strictly dependent on device longevity, whereas device up-front cost is unreliable. This aspect should be valued in the technology purchasing process, and could set the basis for an outcome-based reimbursement system. Our observations may be the benchmark respectively for ICD longevity and daily ICD cost in future comparisons. Independent observations in the real-life scenario are needed to properly value newer technologic improvements.