Organizational model and reactions to alerts in remote monitoring of cardiac implantable electronic devices: A survey from the Home Monitoring Expert Alliance project.

BACKGROUND: This survey aimed to describe the organizational workflow of cardiac implantable electronic devices (CIEDs) remote monitoring (RM) service in ordinary practice. METHODS: A questionnaire was designed for our purpose and completed by 49 sites participating to the Italian Home Monitoring Expert Alliance. RESULTS: A dedicated organizational model for RM was set up for 86% of centers. The median RM team consisted of 2 (Interquartile range [IQR]: 1-3) physicians and 1 (IQR: 0-2) nurse. RM service was available in working hours and the median percentage of patients included was 100% (IQR: 10%-100%) for implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) recipients and 5% (IQR:0%-30%) for pacemakers. In-office follow-up was performed every 12 and 6 months for pacemaker and ICD/CRT recipients, respectively. More than 90% of sites used to activate all technical alerts, with a prompt reaction in case of an out-of-range parameter. The threshold for atrial fibrillation (AF) daily burden notification in most cases ranged from 2.4 to 7.2 hours. All ventricular arrhythmias alerts were usually switched on: an inappropriate therapy or more than one appropriate episode triggered an urgent in-hospital visit. Concerning heart failure, low CRT percentage pacing alert was always used, while the other available notifications were less frequently switched on. CONCLUSIONS: This survey showed that RM service was usually set up with a primary nursing model including on average two responsible physicians and one nurse and mainly offered to ICD/CRT patients. Technical, AF and ventricular arrhythmia alerts triggered prompt reactions, while heart failure related indexes were generally less applied.

Temporal variation in optimal atrioventricular and interventricular delay during cardiac resynchronization therapy.

BACKGROUND: Tailored atrioventricular delay (AVd) and interventricular delay (VVd) combination improves hemodynamics in patients treated with cardiac resynchronization therapy (CRT). Whether tailored AVd-VVd combination changes over time is not known. METHODS AND RESULTS: Twenty-two patients (18 M, aged 69.9 +/- 12.5 years, New York Heart Association class III, QRS > or = 130 ms, ejection fraction 29.6 +/- 8.8%) were implanted with a biventricular device with programmable VVd. Myocardial performance index (MPI) was evaluated during pacing at different VVds and AVds at baseline and after 6 and 12 months. The optimal AVd-VVd combination was identified by the minimum MPI. After optimization, the appropriate AVd-VVd combination was programmed in each patient. MPI at 6-month follow-up after optimization was significantly higher compared with baseline (.79 +/- .21 vs. .59 +/- .15, P < .05). Re-optimization of AVd-VVd combination was required after 6 months in 21 of 22 (95%) patients. Re-optimization significantly reduced MPI compared with the value prior to re-optimization (.56 +/- .15 vs. .79 +/- .21, P < .05). The MPI remained unchanged at 12-month compared with 6-month follow-up (.59 +/- .19 vs. .56 +/-.15, P = NS). Clinical symptoms and reverse left ventricular remodeling were sustained at 6-month and 12-month follow-up. CONCLUSION: Optimal AVd and VVd combination changes over time in patients with heart failure. Sustained improvement in clinical symptoms and reverse left ventricular remodeling after CRT are not temporally associated with improvement in MPI.

Echocardiographic examination of atrioventricular and interventricular delay optimization in cardiac resynchronization therapy.

In 21 patients implanted with a biventricular pacing device with programmable interventricular delay (VVd), the myocardial performance index (MPI) was evaluated during spontaneous sinus rhythm, simultaneous biventricular pacing, and sequential biventricular pacing at different VVds and atrioventricular delays (AVds). The AVd-VVd combination associated with the minimum MPI defined patient-tailored biventricular pacing. Simultaneous biventricular pacing significantly improved MPI compared with spontaneous sinus rhythm. An additional improvement was obtained by tailored biventricular pacing. The optimal AVds were significantly shorter during right ventricular preactivation than during left ventricular preactivation.

Product-experience reporting on endocardial defibrillation leads: a 4-year national perspective.

The medical device industry must implement accurate programs to monitor product performance once the product is released into the market. Product-experience reports provide a means for physicians who use medical devices to provide continuous feedback to manufacturers in order to monitor device performance. We examined product-experience reports sent from Italy over 4 years (2004-2007) related to a single manufacturer's family of permanent endocardial leads (Endotak Reliance, Boston Scientific, MA, USA) used with implantable cardioverter-defibrillators. Out of 15,772 implanted leads, physicians sent in 454 (2.87%) product-experience reports. Only 126 out of 454 (28%) leads were returned to the company; most of these (101 out of 126; 80%) were related to implant procedure. Laboratory analyses of returned leads rarely showed loss of integrity (0.01%). The practice of reporting product performance and returning the device to companies should be strongly encouraged in order to better identify potential issues affecting implantable devices.

Implantation of left ventricular leads using a telescopic catheter system.

BACKGROUND: Implantation procedures for cardiac resynchronization therapy (CRT) remain challenging with regard to coronary sinus (CS) cannulation and left ventricular (LV) lead positioning. Technologic advances in catheter design may facilitate CS cannulation and LV lead placement. AIMS: To evaluate two different telescoping dual-catheter systems, RAPIDO Guiding Catheter System (Group R) and RAPIDO ADVANCE Guiding Catheter System (Group A) (Guidant Inc., St. Paul, MN, USA), during implantation of a CRT device. METHODS: Seventy-four consecutive patients randomly received a CRT device using the R or A system. RESULTS: An LV lead was successfully implanted in 74 patients (100%). (1) Median times for CS cannulation in groups R and A were 0.3 minutes (range from 0.05 to 14 minutes) and 0.5 minutes (range from 0.05 to 9 minutes), respectively (P = NS). (2) Median times for LV lead placement were 8 minutes (range from 0.8 to 100 minutes) and 3.5 minutes (range from 0.25 to 30 minutes), respectively, for groups R and A (P = 0.032). (3) Median total fluoroscopy times were 12.33 minutes (range from 5 to 70 minutes) and 14.33 minutes (range from 6 to 53 minutes) for groups R and A, respectively (P = NS). (4) Median procedural times for CRT implantation were 80 minutes (range from 40 to 200 minutes) and 75 minutes (range from 45 to 180 minutes) (P = NS) in groups R and A, respectively. There were no major complications. CONCLUSION: CS cannulation and LV lead placement with a telescopic dual-catheter system is a safe and feasible approach that may reduce fluoroscopy and overall CRT implantation times. Our observations suggest that the RAPIDO ADVANCE System is faster than the RAPIDO System in terms of median time for LV lead positioning.