Results of the Patient-Related Outcomes of Mechanical lead Extraction Techniques (PROMET) study: a multicentre retrospective study on advanced mechanical lead extraction techniques.

AIMS: Several large studies have documented the outcome of transvenous lead extraction (TLE), focusing on laser and mechanical methods. To date there has been no large series addressing the results obtained with rotational lead extraction tools. This retrospective multicentre study was designed to investigate the outcomes of mechanical and rotational techniques. METHODS AND RESULTS: Data were collected on a total of 2205 patients (age 66.0 ± 15.7 years) with 3849 leads targeted for extraction in six European lead extraction centres. The commonest indication was infection (46%). The targeted leads included 2879 pacemaker leads (74.8%), 949 implantable cardioverter-defibrillator leads (24.6%), and 21 leads for which details were unknown; 46.6% of leads were passive fixation leads. The median lead dwell time was 74 months [interquartile range (IQR) 41-112]. Clinical success was obtained in 97.0% of procedures, and complete extraction was achieved for 96.5% of leads. Major complications occurred in 22/2205 procedures (1%), with a peri-operative or procedure-related mortality rate of 4/2205 (0.18%). Minor complications occurred in 3.1% of procedures. A total of 1552 leads (in 992 patients) with a median dwell time of 106 months (IQR 66-145) were extracted using the Evolution rotational TLE tool. In this subgroup, complete success was obtained for 95.2% of leads with a procedural mortality rate of 0.4%. CONCLUSION: Patient outcomes in the PROMET study compare favourably with other large TLE trials, underlining the capability of rotational TLE tools and techniques to match laser methods in efficacy and surpass them in safety

STereotactic Arrhythmia Radioablation (STAR): the Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary consortium (STOPSTORM.eu) and review of current patterns of STAR practice in Europe

The EU Horizon 2020 Framework-funded Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary (STOPSTORM) consortium has been established as a large research network for investigating STereotactic Arrhythmia Radioablation (STAR) for ventricular tachycardia (VT). The aim is to provide a pooled treatment database to evaluate patterns of practice and outcomes of STAR and finally to harmonize STAR within Europe. The consortium comprises 31 clinical and research institutions. The project is divided into nine work packages (WPs): (i) observational cohort; (ii) standardization and harmonization of target delineation; (iii) harmonized prospective cohort; (iv) quality assurance (QA); (v) analysis and evaluation; (vi, ix) ethics and regulations; and (vii, viii) project coordination and dissemination. To provide a review of current clinical STAR practice in Europe, a comprehensive questionnaire was performed at project start. The STOPSTORM Institutions' experience in VT catheter ablation (83% ≥ 20 ann.) and stereotactic body radiotherapy (59% > 200 ann.) was adequate, and 84 STAR treatments were performed until project launch, while 8/22 centres already recruited VT patients in national clinical trials. The majority currently base their target definition on mapping during VT (96%) and/or pace mapping (75%), reduced voltage areas (63%), or late ventricular potentials (75%) during sinus rhythm. The majority currently apply a single-fraction dose of 25 Gy while planning techniques and dose prescription methods vary greatly. The current clinical STAR practice in the STOPSTORM consortium highlights potential areas of optimization and harmonization for substrate mapping, target delineation, motion management, dosimetry, and QA, which will be addressed in the various WPs

Exact matching of trabectome-mediated ab interno trabeculectomy to conventional trabeculectomy with mitomycin C followed for 2 years

Purpose We used exact matching for a highly balanced comparison of ab interno trabeculectomy (AIT) with the trabectome to trabeculectomy with mitomycin C (TRAB). Methods A total of 5485 patients who underwent AIT were exact-matched to 196 TRAB patients by baseline intraocular pressure (IOP), number of glaucoma medications, and glaucoma type. Nearest-neighbor–matching was applied to age. Success was defined as a final IOP of less than 21 mmHg, IOP reduction of at least 20% reduction from baseline, and no secondary surgical interventions. Outcomes were measured at 1, 3, 6, 12, 18, and 24 months. Results A total of 165 AIT could be matched to 165 TRAB. The mean baseline IOP was 22.3 ± 5.6 mmHg, and the baseline number of glaucoma medications was 2.7 ± 1.1 in both groups. At 24 months, IOP was reduced to 15.8 ± 5.2 mmHg in AIT and 12.4 ± 4.7 mmHg in TRAB. IOP was lower than baseline at all visits (p  0.01). Secondary surgical interventions had the highest impact on success and became necessary in 15 AIT and 59 TRAB patients. Thirty-two challenging events occurred in TRAB and none in AIT. Conclusion Both AIT and TRAB reduced IOP and medications. This reduction was more significant in TRAB but at the expense of four times as many secondary interventions

Transvenous lead extraction: The influence of age on patient outcomes in the PROMET study cohort

Background Cardiac implantable electronic device (CIED) therapy contributes to an improvement in morbidity and mortality across all patient demographics. Patient age is a recognized risk factor for unfavorable outcomes in invasive procedures. This is the largest series of non-laser transvenous lead extraction (TLE) evaluating the association between patient age and procedure outcomes. Methods Data of 2205 (3849 leads) patients was collected retrospectively from six European TLE centers between January 2005–December 2018 in the PROMET study. Of these, 153 patients with 319 leads were excluded for incomplete data. A comparison of outcomes was performed between the age groups young [< 50 years], young intermediate [50–69 years], older intermediate [70–79 years], and octogenarian [≥80 years]. Results Infection was most common indication for TLE in the octogenarian cohort, less common in the younger population (60.1% vs. 33.2%, respectively, p < .01). High-voltage leads were extracted most frequently from young patients, less frequently from octogenarians (31.6% vs. 10%, p < .001), while the opposite was evident for pacemaker leads (p < .001). Rotational sheath use was equally prevalent across all patient groups (p = .79). Minor and major complications across all the age groups were statistically similar, as was procedural success; the 30-day mortality was most significant in the octogenarian and least in the young patients (4.9% vs. 0.4%, p = .005). Propensity matching multivariate analysis found systemic infection, lead dwell time, and patient age (p = .013, OR 1.064 [1.013–1.116]) increased risk of 30-day mortality. Conclusion TLE is safe and effective across all age groups. 30-day mortality risk is significantly higher in the older patients

Patient related outcomes of mechanical lead extraction techniques (PROMET) study: A comparison of two professions

BACKGROUND With an increasing number of cardiac implantable electronic devices (CIEDs), there has been a paralleled increase in demand for transvenous lead extraction (TLE). Cardiac surgeons (CS) and cardiologists perform TLE; however, data comparing the two groups of operators is scarce. OBJECTIVE We compared the outcomes of TLE performed by cardiologists and CS from six European lead extraction units. METHOD Data was collected retrospectively of 2205 patients who had 3849 leads extracted (PROMET) between 2005 and 2018. Patient demographics and procedural outcomes were compared between the CS and cardiologist groups, using propensity score matching. A multivariate regression analysis was also performed for variables associated with 30-day mortality. RESULTS CS performed the majority of extractions (59.8%), of leads with longer dwell times (90 [57-129 interquartile range (IQR)] vs. 62 [31-102 IQR] months, CS vs. cardiologists, p < .001) and with pre-dominantly non-infectious indications (57.4% vs. 50.2%, CS vs. cardiologists, p < .001). CS achieved a higher complete success per lead than the cardiologists (98.1% vs. 95.7%, respectively, p < .01), with a higher number of minor complications (5.51% vs. 2.1%, p < .01) and similar number of major complications (0.47% vs. 1.3%, p = .12). Thirty-day mortality was similarly low in the CS and cardiologist groups (1.76% vs. 0.94%, p = .21). Unmatched data multivariate analysis revealed infection indication (OR 6.12 [1.9-20.3], p < .01), procedure duration (OR 1.01 [1.01-1.02], p < .01) and CS operator (OR 2.67, [1.12-6.37], p = .027) were associated with 30-day mortality. CONCLUSION TLE by CS was performed with similar safety and higher efficacy compared to cardiologists in high and medium-volume lead extraction centers