Outsourcing the Remote Management of Cardiac Implantable Electronic Devices: Medical Care Quality Improvement Project.

BACKGROUND: Remote management is partially replacing routine follow-up in patients implanted with cardiac implantable electronic devices (CIEDs). Although it reduces clinical staff time compared with standard in-office follow-up, a new definition of roles and responsibilities may be needed to review remote transmissions in an effective, efficient, and timely manner. Whether remote triage may be outsourced to an external remote monitoring center (ERMC) is still unclear. OBJECTIVE: The aim of this health care quality improvement project was to evaluate the feasibility of outsourcing remote triage to an ERMC to improve patient care and health care resource utilization. METHODS: Patients (N=153) with implanted CIEDs were followed up for 8 months. An ERMC composed of nurses and physicians reviewed remote transmissions daily following a specific remote monitoring (RM) protocol. A 6-month benchmarking phase where patients' transmissions were managed directly by hospital staff was evaluated as a term of comparison. RESULTS: A total of 654 transmissions were recorded in the RM system and managed by the ERMC team within 2 working days, showing a significant time reduction compared with standard RM management (100% vs 11%, respectively, within 2 days; P<.001). A total of 84.3% (551/654) of the transmissions did not include a prioritized event and did not require escalation to the hospital clinician. High priority was assigned to 2.3% (15/654) of transmissions, which were communicated to the hospital team by email within 1 working day. Nonurgent device status events occurred in 88 cases and were communicated to the hospital within 2 working days. Of these, 11% (10/88) were followed by a hospitalization. CONCLUSIONS: The outsourcing of RM management to an ERMC safely provides efficacy and efficiency gains in patients' care compared with a standard in-hospital management. Moreover, the externalization of RM management could be a key tool for saving dedicated staff and facility time with possible positive economic impact. TRIAL REGISTRATION: ClinicalTrials.gov NCT01007474; http://clinicaltrials.gov/ct2/show/NCT01007474.

Performance of the Durata implantable cardioverter defibrillator lead: results of an independent multicenter study.

AIMS: The high rate of implantable cardioverter defibrillator (ICD) lead failures related to the Sprint Fidelis' and Riata's design have raised serious concerns about the reliability of ICD leads. The St. Jude Medical Durata family of leads replaced the preceding Riata line following increased rates of lead failure (1.17% per year). The aim of our study was to evaluate the long-term performance of the Durata lead. METHODS: Eight hundred and eighteen Durata ICD leads were implanted in 11 Italian centers. The incidence of lead failure, defined as a sudden rise in long-term pacing or defibrillation impedance and/or a sudden change in R-wave amplitude and capture thresholds, was assessed. The incidences of lead dislodgment and lead perforation were also evaluated. RESULTS: During a median follow-up of 1353 days (3.7 years; 25-75th interquartile range 806-1887 days) lead failure occurred in 16/818 leads (0.54%/year). The overall survival, free of lead failure, was 98.9% at 3 years, 98.2% at 4 years and 97.5% at 5 years. Lead dislodgment occurred in 12/818 leads with an incidence of 0.4%/year. No cases of cardiac perforation were reported. No major adverse events were reported except for two cases of inappropriate shocks as a consequence of failure or dislodgment. CONCLUSION: Our study suggests that the Durata lead does not engender a higher risk of failure. Overall survival, free from lead failure, was found to be higher than previously reported for the Riata lead.

Bipolar active fixation left ventricular lead or quadripolar passive fixation lead? An Italian multicenter experience.

AIMS: About one-third of patients receiving cardiac resynchronization therapy (CRT) are not responders, due to either patient selection or technical issues. Left ventricular quadripolar passive fixation leads (QPL) and bipolar active fixation (BAF) leads have been designed to ensure a targeted left ventricular stimulation area, minimizing lead dislodgments and phrenic nerve stimulation (PNS). The aim was to compare real-world safety and efficacy of BAF (Attain Stability, Medtronic Plc.) and QPL (Attain Performa, Medtronic Plc.). METHODS: We performed a retrospective analysis examining procedural and follow-up data of 261 BAF and 124 QPL (programmed to single-site left ventricular pacing), included in the ClinicalService project from 16 Italian hospitals. RESULTS: At median follow-up of 12 months, no difference in left ventricular pacing threshold was recorded between BAF and QPL (1.3 ±â€Š0.9 V @0.4 ms vs. 1.3 ±â€Š1.0 V @0.4 ms; P = 0.749). Total left ventricular lead dislodgement rate was 1.43/100 patient-years in BAF vs. 2.9/100 patient-years in QPL (P = 0.583). However, no dislodgements occurred among BAF after hospital discharge. Events requiring repeated surgery or permanently turning CRT off occurred in 0.8% of BAF, as compared with 4.0% of QPL (P = 0.025). There was no difference between groups in the echo CRT responders' rate (70% of BAF and 66% of QPL; P = 0.589) or in the annual rate of heart failure hospitalization (P = 0.513). CONCLUSIONS: BAF resulted in noninferior clinical outcome and CRT responders' rate in comparison to QPL. Moreover, BAF ensured more precise and stable placement in cardiac veins, with comparable electrical performance and less than 1% patients with unsolved PNS.

[Short-term effects of stimulation in the right ventricular outflow tract]. / Effetti a breve termine della stimolazione in tratto di efflusso del ventricolo destro.

INTRODUCTION: Stimulation in the right ventricular outflow tract (RVOT) showed better clinical and hemodynamic results at short, medium and long term than apical pacing. METHODS: We enrolled 30 patients undergoing pacemaker implantation with positioning of electrocatheters in the high or low RVOT. All patients underwent clinical, echocardiographic and electrocardiographic evaluation after implantation and at 6-month follow-up. RESULTS: After 6 months of pacing, no significant changes in echocardiographic parameters were observed, whereas differences were found between the duration of spontaneous QRS and the duration of QRS stimulated at the time of implantation. Electrocatheter implantation in the high RVOT showed a particular benefit. CONCLUSIONS: Chronic stimulation in RVOT, preferably in the high tract, can be considered a viable alternative to apical pacing in patients with likely high rates of stimulation, especially of young age.

Efficacy of a tool combining guide-wire and stylet for the left ventricular lead positioning.

AIMS: The left ventricular (LV) lead for cardiac resynchronization therapy (CRT) is usually positioned in the coronary sinus via a stylet-guided or an 'over-the-wire' approach. Recently, a new tool has been developed, the Medtronic Attain Hybrid, that combines guide-wire and stylet features. We assessed its safety and efficacy in comparison with standard tools currently used in clinical practice. METHODS AND RESULTS: Patients undergoing standard CRT device implantation were enrolled in seven Italian centres. In the preliminary phase of the study (Phase I), data were collected during implantation procedures performed with standard tools (three patients per centre). Subsequently, the Attain Hybrid was made available in the centres and data were collected for all consecutive patients undergoing implantation during the following year. A learning phase was considered (Phase II), and the last three patients per centre (Phase III) were used for comparison with Phase I. One hundred and seventeen patients were enrolled: 21 patients in Phase I, 75 in Phase II, and 21 in Phase III. Rates of successful implantation were similar in Phases I and III (95 vs. 100%, P=1.000). The pre-defined target vein was reached in 15 (71%) patients in Phase I and in 21 (100%) patients in Phase III (P=0.021). In 10 (48%) procedures during Phase I, LV lead positioning necessitated switching from guide-wire to stylet; this proportion decreased during Phase III (14%, P=0.043). Mean LV positioning time was 16±7 min in Phase I and 11±6 min in Phase III (P=0.040). No adverse events or lead-related complications were detected on implantation or during a follow-up of 6±4 months. CONCLUSION: The Attain Hybrid is safe and effective. It significantly improves target vein accessibility and reduces procedural time in comparison with conventional tools.

Usefulness of mechanical transvenous dilation and location of areas of adherence in patients undergoing coronary sinus lead extraction.

AIMS: Few data have been currently reported on the outcome of coronary sinus (CS) lead removal, particularly using mechanical dilation (MD). We aimed to evaluate feasibility, safety, and effectiveness of CS lead extraction, focusing on MD usefulness, in the event that lead traction (LT) was ineffective. METHODS AND RESULTS: We studied 37 consecutive patients (30 males, mean age 68.1, range 52-80), who underwent left ventricle (LV) pacing lead removal; the indication for extraction was local infection in 16 patients (43.3%), sepsis in 11 patients (29.7%), and lead malfunction in 10 patients (27%). The procedure was first attempted by LT, followed, if unsuccessful, by MD using polypropylene sheaths. All CS leads (time from implant 19.5 +/- 16.5, range 2-84 months) were successfully removed; LT was effective (LT group) in 27 patients (73%) and ineffective in 10 patients (27%), for whom MD was necessary (MD group). There were no major complications. The areas of adherence were in the CS in only one patient. No differences were noted in the data analysed between LT and MD groups; in particular, time from implant was similar in the two groups (MD vs. LT group: 17 +/- 8.9 vs. 20.4 +/- 18.6 months; P = ns). CONCLUSION: Our study suggests that CS leads, after medium-term implantation, can be effectively and safely removed using MD with polypropylene sheaths, in the case of unsuccessful LT. No pre-operative elements predictive of LT failure could be identified. Areas of adherence were rarely located in the CS or its tributaries.

New-onset ventricular tachycardia after cardiac resynchronization therapy.

It is well established that coronary artery disease with healed myocardial infarction is the most common backdrop for ventricular tachycardia (VT). Although the clinical benefits of biventricular pacing (BivP) in the treatment of severe heart failure are well documented, exact relation with ventricular arrhythmias remains still unclear. We describe a case of a patient, whitout a previous history of arrhythmic episodes, in which the onset of several episodes of VT presented immediatly after cardiac resynchronization therapy (CRT) and did not occur after BivP discontinuation.

Pacing and implantable cardioverter-defibrillator transvenous lead extraction.

During the last 20 years, the transvenous techniques for the extraction of chronically implanted pacing (PL) and defibrillating leads (DL) achieved a high success rate. However the procedures are often complex and are associated with a small but significant risk. The operators' experience and the availability of different approaches for difficult cases seem to affect both the results and the complications. This paper represents a review of indications, techniques and results of a 10-year experience in the field of transvenous lead extraction. Since January 1997, extraction was attempted in 1330 leads; among these 1137 were successfully extracted with the standard mechanical approach (success rate 85.4%); in 12 leads was performed a partial extraction (0.9%) and 1 was inapplicable (0.07%). The jugular approach was performed in 180 leads (164 PL and 16 DL): 39 were intravascular free-floating leads (38 PL and 1 DL) and 141 were difficult exposed leads (126 PL and 15 DL) allowing extraction in 178/180 (98.8%) cases. After this approach, the final results were: total extraction 98.88%, partial extraction 0.90%, unextracted 0.15%, and not applicable 0.07%. Major complications occurred in 4 cases (0.3%) and were cardiac tamponade (2 underwent successful pericardiocentesis, 1 surgical repair, and 1 patient died). No complications were directly related to the jugular approach. In conclusion, transvenous lead extraction is an effective and safe procedure. The success rate and the incidence of complications are highly affected by the staff experience. The use of the jugular approach, in the presence of free-floating or difficult exposed leads, increases both safety and success rate.