Follow-up of CRT-D patients downgraded to CRT-P at the time of generator exchange.

Background: Some patients with cardiac resynchronisation therapy (CRT) experience super-response (LVEF improvements to ≥50%). At generator exchange (GE), downgrading (DG) from CRT-defibrillator (CRT-D) to CRT-pacemaker (CRT-P) could be an option for these patients on primary prevention ICD indication and no required ICD therapies. Long-term data on arrhythmic events in super-responders is scarce. Methods: CRT-D patients with LVEF improvement to ≥50% at GE were identified in four large centres for retrospective analysis. Mortality, significant ventricular tachyarrhythmia and appropriate ICD-therapy were determined, and patient analysis was split into two groups (downgraded to CRT-P or not). Results: Sixty-six patients (53% male, 26% coronary artery disease) on primary prevention were followed for a median of 129 months [IQR: 101-155] after implantation. 27 (41%) patients were downgraded to CRT-P at GE after a median of 68 [IQR: 58-98] months (LVEF 54% ± 4%). The other 39 (59%) continued with CRT-D therapy (LVEF 52% ± 6%). No cardiac death or significant arrhythmia occurred in the CRT-P group (median follow-up (FU) 38 months [IQR: 29-53]). Three appropriate ICD-therapies occurred in the CRT-D group [median FU 70 months (IQR: 39-97)]. Annualized event-rates after DG/GE were 1.5%/year and 1.0%/year in the CRT-D group and the whole cohort, respectively. Conclusions: No significant tachyarrhythmia were detected in the patients downgraded to CRT-P during follow-up. However, three events were observed in the CRT-D group. Whilst downgrading CRT-D patients is an option, a small residual risk for arrhythmic events remains and decisions regarding downgrade should be made on a case-by-case basis.

Inter-hospital comparison of working time allocation among internal medicine residents using time-motion observations: an innovative benchmarking tool.

OBJECTIVES: The vast majority of residents' working time is spent away from patients. In hospital practice, many factors may influence the resident's working day structure.Using an innovative method, we aimed to compare working time allocation among internal medicine residents using time-motion observations. The first study goal was to describe how the method could be used for inter-hospital comparison. The secondary goal was to learn about specific differences in the resident's working day structure in university and non-university hospital settings. DESIGN: Two separate time-motion studies. Trained peer-observers followed the residents during weekday day shifts with a tablet, able to record 22 different activities and corresponding context (with patient, phone, colleague or computer). SETTING: Internal medicine residencies at a university (May-July 2015) and a non-university (September-October 2016) community hospital. PARTICIPANTS: 28 residents (mean age: 29 years, average postgraduate training: 30 months) at university hospital, 21 residents (mean age: 30 years, average postgraduate training: 17 months) at non-university hospital. OUTCOMES: Time spent with patients and time dedicated to activities directly related to patients; description of main differences of time allocation between hospitals. RESULTS: Cumulatively 1051 hours of observation (566 (university hospital)+486 (non-university hospital)) and 92 day shifts (49+43) were evaluated. Daily working time was 11.5 versus 11.3 hours. A median daily period of 195 min (IQR 179-211, 27.9%) and 116 min (IQR 98-134, 17.2%) (p<0.001) was dedicated to direct patient care, respectively. CONCLUSIONS: We successfully identified differences potentially related to each hospital structure and organisation. Inter-hospital comparisons could help set up interventions aiming to improve workday structure and experience of residents.

The Medtronic Sprint Fidelis® lead history revisited-Extended follow-up of passive leads.

BACKGROUND: Due to high failure rates, Medtronic withdrew the Sprint Fidelis lead (SFL) from the market. Passive fixation lead models exhibited better survival than active models, but most studies have limited follow-up. Aim of this study was to give insights into passive lead survival with a follow-up of 10 years. METHODS: In two large Swiss centers, patients with passive SFLs were identified and data from routine implantable cardioverter defibrillator (ICD) follow-ups were collected. Patients were censored at time of death, last device interrogation (if lost to follow-up), time of lead revision (in non-SFL-related problems), or at database closure (31th December 2017). We defined lead failure as any of the following: lead fracture with inappropriate discharge; sudden increase in low-voltage impedance to >1500 or high-voltage impedance to >100 Ω; >300 nonphysiological short VV-intervals. RESULTS: We identified 145 patients. Age at implant was 60 ± 12 years with a median follow-up of 10.2 (interquartile range [IQR]: 5.0-11.2) years. Thirty-five percent of patients died after 5.4 ± 2.7 years. A total of 19 leads (13%) failed after 6.7 ± 3.2 years (range: 1.2-12.0). Overt malfunction with shocks existed in four patients (3%). Cumulative lead survival was 93.1% at 6, 88.2% at 8, 83.8% at 10, and 77.6% at 11 years, respectively, with 35% of implanted leads under monitoring at 10 years. Lead survival fits best a Weibull distribution with accelerating failure rates (k = 1.95, 95% CI 1.32-2.87, P < 0.001). CONCLUSIONS: During very long-term follow-up, failure rate of the passive SFL shows an increase resulting in an impaired lead survival of 84% at 10 years.

Very late follow-up of a passive defibrillator lead under recall: do failure rates increase during long-term observation.

BACKGROUND: The Medtronic Sprint Fidelis lead (SFL; Medtronic Inc., Minneapolis, MN, USA) has a significantly impaired long-term survival, and active fixation leads fare worse than passive leads. The goal of this study was to present data of a series of passive SFL only with very long mean follow-up of more than 6 years. METHODS: Patients in whom a passive SFL was implanted in two large Swiss centers were followed. We excluded eight (5.5%) patients with a follow-up of <6 months. Patients who died or were lost during follow-up were censored at death or last device check, all others on January 31, 2014. We employed two different definitions of failure: strict = fracture with inappropriate discharge; sudden increase in impedance >1,500 or high-voltage impedance >100 Ohm; >300 nonphysiological short interventricular-intervals. Lenient = any of the above plus a linear increase in impedance >1,500 Ohm or a linear decrease in sensing to a level that treating cardiologists considered inappropriate. RESULTS: We included 137 patients. Age was 60 ± 12 years. Mean and median follow-up were 6.2 ± 2.1 and 6.8 (interquartile range 4.8-7.8) years. Applying the strict definition, 12 leads (8.8%) were replaced after 4.9 ± 2.4 years (range 1.2-8.1). Applying the lenient definition, 14 leads (10.2%) failed. Cumulative lead survival was 98.5% at 3, 96.9% at 4, 94.2% at 5, and 93.1% at 6 years. Leads "at risk" were: n = 122 (89%), 115 (84%), 101 (74%), and 88 (64%). CONCLUSIONS: In this population with passive SFLs, 5-year lead survival is impaired with 94.2% based on 74% of leads "at risk" at this time point.

Long-term performance of the Medtronic Sprint Fidelis lead: a matter of lead type?

AIMS: In 2007, the Medtronic™ Sprint Fidelis(®) lead was withdrawn from the market due to elevated failure rates. Since then, several studies were published with failure rates between 1.3 and 3.75%/year. However, they included a very high percentage of active fixation leads. Data in a population with passive leads are missing. METHODS AND RESULTS: All 166 patients who received a Fidelis lead between December 2004 and October 2007 in two teaching hospitals were identified. We excluded nine patients with incomplete data and 18 with active fixation leads. The study population thus consists of 139 patients with passive leads. Pacing and high-voltage impedance values were systematically collected at implant and in intervals of 6 months. Follow-up was 49 ± 15 months. All leads were 6948 models. During a follow-up of 41 ± 15 months, nine leads (6.5%) failed. Annual failure rate was 1.9%/year (95% CI 0.4-4.2), cumulative 5-year survival 95.8%. There were no differences between leads used in resynchronization and non-resynchronization devices (8.9 and 5.3%, P value 0.47). CONCLUSION: In a population with only passive leads, the Fidelis lead exhibited an impaired long-term survival, but performance was better than in previous studies in which >90% of leads were active models.