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.

Persistent left superior vena cava transvenous lead extraction: A European experience.

BACKGROUND: Transvenous lead extraction (TLE) is rising in parallel to cardiac implantable electronic device implantations. Persistent left side superior vena cava (PLSVC) is a relatively common anatomical variant in the healthy population; TLE in patients with a PLSVC is rare. METHOD: Data were collated from 6 European TLE institutes of 10 patients who had undergone lead extraction with a PLSVC. Patient demographics, procedural challenges and outcomes were reported. RESULTS: Ten patients aged 73.4 ± 7.8 years (60% male) underwent TLE of 20 leads (3 left ventricle, 10 right ventricle, 7 right atrium) with dwell time of 82.95 ± 39.1 months. Of the 10 cases, 4 had an infection indication and 5 were biventricular system extractions; 25% of the extracted leads were defibrillator leads. The majority of the procedures were completed in the cardiac catheterization suite (80%) under general anaesthesia (60%) by cardiologists (80%) using a rotational powered sheath (65%). The Tandem approach was used successfully in 3 cases. Complete procedural success was obtained in 100% of cases in the absence of complications within 127.4 ± 74.7 min. There was no 30-day mortality. CONCLUSION: TLE in PLSVC is feasible albeit rare. Standard extraction techniques in experienced hands are associated with favorable outcomes; the Tandem procedure may be an additional technique to improve the safety and efficacy of TLE in PLSVC.

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.

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.

Leadless pacemaker extraction from a single-center perspective.

BACKGROUND: Leadless pacemaker can be considered as a technical revolution in cardiac pacing devices, with clear advantages over conventional pacemakers in overcoming all lead-related complications. However, the management of these devices once they reach the end of life (EOL) of the battery is still controversial. In the next years, there will be an increase in the need to define a clear strategy in the management of leadless PM once they reach their EOL. Safe extraction of these devices will define in a great manner this strategy METHODS: We performed the extraction of three functioning Nanostim leadless pacemaker prophylactically in two females and one male patients as part of the Nanostim battery depletion field action recommendation. All patients had a prior transesophageal 3D echocardiography to determine the device intracardiac mobility and the extent of possible endothelialization. For the extractions, we used the Nanostim Retrieval Catheter S1RSIN (St. Jude Medical, St. Paul, MN, USA), which is a proprietary catheter provided by the manufacturing company based on a lasso. RESULTS: Complete extraction of the devices was achieved in all patients using a relatively short fluoroscopic time (16, 19, and 12 minutes). CONCLUSIONS: The extraction of leadless pacemakers can be considered as a safe and feasible procedure using the tools provided by the manufacturer and designed for the extraction. However, a very low threshold must be maintained to avoid any risk to the patients. Our extraction time ranges are between 983 and 1,070 days, nevertheless it is necessary to gather more long-term data to assess the feasibility and safety of these procedures.

Evaluación de los resultados de la cirugía reconstructiva del esqueleto mitroaórtico en la endocarditis infecciosa activa / Evaluation of the results of surgical reconstruction of the mitroaortic skeleton in active infective endocarditis

Resumen Introducción: La cirugía en la endocarditis infecciosa activa con múltiples abscesos y destrucción del cuerpo fibroso intervalvular, representa un procedimiento de alta exigencia técnica y de difícil manejo postoperatorio. Se presenta la experiencia con una técnica original de resección radical y reconstrucción posterior con pericardio bovino. Material y métodos: En los últimos ocho años en nuestro centro se intervinieron 29 pacientes con endocarditis infecciosa activa y abscesos paravalvulares que destruían la unión mitro-aórtica (20 sobre prótesis y 9 sobre válvula nativa): 13 de ellos llegaron al quirófano en situación de sepsis grave. El EuroScore I medio de la serie fue 36 ±22,7%. Para tratarlos se realizó una resección amplia del tejido infectado y posterior reconstrucción del cuerpo fibroso con pericardio bovino fijado en glutaraldehído, mediante una técnica original. Resultados: La mortalidad hospitalaria de la serie fue del 20,7%. El seguimiento medio fue de 34,2 ± 28 meses con un máximo de 8 años. Dos pacientes requirieron reintervención a causa de fugas periprotésicas aórticas. Se registró una sola recidiva del proceso infeccioso. Dos pacientes fallecieron durante el seguimiento posterior al alta, por causas no cardíacas. Conclusiones: La resección amplia de la unión mitro-aórtica y la posterior reconstrucción con pericardio bovino, en algunos casos puede ser la única opción quirúrgica para salvar la vida de un paciente. Los autores consideran que la técnica presentada es un procedimiento reproducible, con morbilidad y mortalidad aceptables, y con el que se minimizaría el riesgo de recidivas futuras.

Abstract Introduction : Surgical intervention of active infective endocarditis with multiple abscesses and destruction of the intervalvular fibrous body represents a technically demanding procedure with a difficult postoperative management. The experience is presented with an original technique for radical resection and subsequent reconstruction using bovine pericardium. Material and methods: During the last eight years in our centre 29 patients with active infective endocarditis and paravalvular abscesses that destroyed the microaortic union underwent surgery (20 over prosthesis and 9 over native valve): 13 of them reached the operating room with severe sepsis. Average EuroScore I of the series was 36 ± 22.7%. Treatment consisted of a broad resection of infected tissue and subsequent reconstruction of the fibrous body with glutaraldehyde fixed bovine pericardium, by means of an original technique. Results: Hospital mortality of the series was 20.7%. Average follow-up was 34.2 ± 28 months, with a maximum of 8 years. Two patients required a reoperation due to periprosthetic aortic valve leaks. Only one relapse of the infectious process was registered. Two patients passed away during follow-up after discharge, for non-cardiac reasons. Conclusion: Broad resection of the mitroaortic union and subsequent reconstruction with bovine pericardium can in some cases be the only surgical option to save a patient's life. The authors consider that the presented technique is a repeatable procedure, with acceptable morbidity and mortality, that would minimise the risk of future recurrence.

Implantation of cardioverter defibrillators with minimal fluoroscopy using a three-dimensional navigation system: a feasibility study.

AIMS: Fluoroscopy is necessary to implant cardioverter defibrillators using the conventional approach. Modern electroanatomic navigation systems allow the visualization of multiple catheters and, as they are capable of rendering precise geometrical reconstructions of cardiac chambers, have been used for fluoroscopy-free electrophysiological procedures. The aim of our study was to assess the feasibility of non-fluoroscopic implants using a three-dimensional navigation system. METHODS AND RESULTS: The NavX system was used to create the virtual anatomies of heart chambers and thoracic veins. Defibrillator leads were placed at stable positions using exclusively the electrical and anatomical information provided by the navigator. A single fluoroscopy shot confirmed final lead positions. Thirty-five consecutive patients had 30 single-chamber and 5 dual-chamber defibrillators implanted. Cardiac chambers geometries were developed in 10 ± 4.3 min. Ventricular and atrial leads were implanted, with suitable positions and electrical parameters being achieved, in 18 ± 22 and 16 ± 9 min, respectively. The final confirmatory shot was the only fluoroscopy needed in 31 (89%) cases. Two patients needed fluoroscopy-guided relocation of the ventricular lead due to high defibrillation threshold and a breakdown of the active-fixation mechanism, respectively. In one patient the ventricular lead was totally extracted and reimplanted because a loop has formed in the vena cava, and one patient required fluoroscopy-guided subclavian puncture. In five cases (16%), the position of the proximal defibrillation coil was minimally modified with fluoroscopy due to incomplete geometric reconstruction of the superior vena cava. CONCLUSION: Fluoroscopy-free defibrillators implantation is feasible using a navigation system. Suitable placement of the proximal coil is a critical stage and requires a reliable and complete reconstruction of the superior vena cava.