Sergio Valsecchi

Remote Monitoring of CRT-ICD: The Multicenter Italian CareLink Evaluation—Ease of Use, Acceptance, and Organizational Implications

Purpose: The Medtronic CareLink allows remote implantable device follow‐up. In this first European experience with CareLink, we assessed the ease of use of the system, the acceptance, and satisfaction of patients and clinicians.

Monitoring Intrathoracic Impedance with an Implantable Defibrillator Reduces Hospitalizations in Patients with Heart Failure

Purpose: Some implantable cardioverter‐defibrillators (ICDs) are now able to monitor intrathoracic impedance. The aim of the study was to describe the use of such monitoring in clinical practice and to evaluate the clinical impact of the fluid accumulation alert feature of these ICDs.

Prediction of response to cardiac resynchronization therapy: The selection of candidates for CRT (SCART) study

Background: The aim of this study was to evaluate the ability of baseline clinical and echocardiographic parameters to predict a positive response to CRT.

Long-Term Complications Related to Biventricular Defibrillator Implantation Rate of Surgical Revisions and Impact on Survival: Insights From the Italian ClinicalService Database

Background— Long-term data on device-related untoward events in patients receiving defibrillators for resynchronization therapy (CRT-D) are lacking. We quantified the frequency of repeat invasive procedures and the nature of long-term complications in current clinical practice and examined possible predictors of device-related events and their association with long-term patient outcome. Methods and Results— We analyzed data from 3253 patients who underwent de novo successful implantation of CRT-D and were followed up for a median of 18 months (25th to 75th percentiles: 9 to 30) in 117 Italian centers. Device-related events were reported in 416 patients, and, specifically, surgical interventions for system revision were described in 390 patients. Four years after the implantation procedure, 50% of patients underwent surgical revision for battery depletion and 14% for unanticipated events. For comparison, at 4 years battery depletion occurred in 10% and 13% of patients who received single- and dual-chamber defibrillators at the study centers, and unanticipated events were reported as 4% and 9%, respectively. In CRT-D, infections occurred at a rate of 1.0%/y, and the risk of infections increased after device replacement procedures (hazard ratio, 2.04; 95% confidence interval, 1.01 to 4.09; P =0.045). Left ventricular lead dislodgements were reported at a rate of 2.3%/y and were predicted by longer fluoroscopy time and higher pacing threshold on implantation. Device-related events were not associated with a worse clinical outcome; indeed, the risk of death was similar in patients with and without surgical revision (hazard ratio, 0.90; 95% confidence interval, 0.56 to 1.47; P =0.682). Conclusions— In current clinical practice device-related events are more frequent in CRT-D than in single- or dual-chamber defibrillators, and are frequently managed by surgical intervention for system revision. However, a worse clinical outcome is not associated with these events. Clinical Trial Registration— URL: . Unique identifier: [NCT01007474][1]. # Clinical Perspective {#article-title-32} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01007474&atom=%2Fcirculationaha%2F123%2F22%2F2526.atomBackground— Long-term data on device-related untoward events in patients receiving defibrillators for resynchronization therapy (CRT-D) are lacking. We quantified the frequency of repeat invasive procedures and the nature of long-term complications in current clinical practice and examined possible predictors of device-related events and their association with long-term patient outcome. Methods and Results— We analyzed data from 3253 patients who underwent de novo successful implantation of CRT-D and were followed up for a median of 18 months (25th to 75th percentiles: 9 to 30) in 117 Italian centers. Device-related events were reported in 416 patients, and, specifically, surgical interventions for system revision were described in 390 patients. Four years after the implantation procedure, 50% of patients underwent surgical revision for battery depletion and 14% for unanticipated events. For comparison, at 4 years battery depletion occurred in 10% and 13% of patients who received single- and dual-chamber defibrillators at the study centers, and unanticipated events were reported as 4% and 9%, respectively. In CRT-D, infections occurred at a rate of 1.0%/y, and the risk of infections increased after device replacement procedures (hazard ratio, 2.04; 95% confidence interval, 1.01 to 4.09; P=0.045). Left ventricular lead dislodgements were reported at a rate of 2.3%/y and were predicted by longer fluoroscopy time and higher pacing threshold on implantation. Device-related events were not associated with a worse clinical outcome; indeed, the risk of death was similar in patients with and without surgical revision (hazard ratio, 0.90; 95% confidence interval, 0.56 to 1.47; P=0.682). Conclusions— In current clinical practice device-related events are more frequent in CRT-D than in single- or dual-chamber defibrillators, and are frequently managed by surgical intervention for system revision. However, a worse clinical outcome is not associated with these events. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01007474.

Single-operator experience with a mechanical approach for removal of pacing and implantable defibrillator leads

AIMS Recently, a mechanical single-sheath technique with a multiple venous entry-site approach for the removal of pacemaker and implantable defibrillator leads was reported to have a high success rate and few complications. In our institution, this technique of lead removal has been used since 2002. In this paper, we report our experience, with the aim of evaluating the effectiveness and safety of the proposed procedure. METHODS AND RESULTS This study is a retrospective analysis of the case records of all patients referred to our institution for transvenous lead extraction, according to class I or II Heart Rhythm Society indications. Over 7 years, 300 consecutive patients underwent procedures for transvenous removal of 518 leads. The most frequent indication for extraction was infection (74%). Complete removal of 502 (96.9%) leads and partial removal of 10 leads (1.9%) were achieved. Six leads (1.2%) could not be removed. All defibrillation coils and coronary sinus leads were successfully removed. There were no procedure-related deaths but only one major complication (0.3%). CONCLUSION Our experience shows that the proposed mechanical technique is very effective and associated with few serious complications, thus confirming previous findings. This approach may be reproduced in other settings with very satisfactory results.

Epicardial ganglionated plexus stimulation decreases postoperative inflammatory response in humans

BACKGROUND Surgical cardiac revascularization produces a high degree of systemic inflammation and the secretion of several cytokines. Intensive postoperative inflammation may increase the incidence of postoperative atrial fibrillation and favor organ dysfunctions. No data documenting the anti-inflammatory properties of epicardial vagal ganglionated plexus stimulation are available. OBJECTIVE To verify the feasibility and safety of postoperative inferior vena cava-inferior atrial ganglionated plexus (IVC-IAGP) burst stimulation and the effectiveness of this approach in reducing serum levels of inflammatory cytokines. METHODS In 27 patients who were candidates for off-pump surgical revascularization, the IVC-IAGP was located during surgery, a temporary wire was inserted, and a negative atrioventricular node dromotropic effect was obtained in 20 patients on applying high-frequency burst stimulation. In 5 patients atrial fibrillation or phrenic nerve stimulation was induced, and the remaining 15 patients served as the experimental group. Twenty additional patients underwent off-pump surgical revascularization without IVC-IAGP stimulation and served as the control group. On arrival in the intensive care unit, the experimental group underwent IVC-IAGP stimulation for 6 hours. Blood samples were collected at different times. RESULTS The serum levels of cytokines were not statistically different at baseline and on arrival in the intensive care unit between the groups, while they proved statistically different after 6 hours of stimulation: interleukin-6 (EG: 121 ± 71 pg/mL vs CG: 280 ± 194 pg/mL; P = .004), tumor necrosis factor-α (EG: 2.68 ± 1.81 pg/mL vs CG: 5.87 ± 3.48 pg/mL; P = .003), vascular endothelial growth factor (EG: 93 ± 43 pg/mL vs CG: 177 ± 86 pg/mL; P = .002), and epidermal growth factor (EG: 79 ± 48 pg/mL vs CG: 138 ± 76 pg/mL; P = .012). CONCLUSIONS Prolonged burst IVC-IAGP stimulation after surgical revascularization appears to be feasible and safe and significantly reduces inflammatory cytokines in the postoperative period.

Dual-site left ventricular cardiac resynchronization therapy.

Simultaneous stimulation of 2 left ventricular (LV) sites could enhance the effectiveness of cardiac resynchronization therapy (CRT). The aim of this study was to evaluate the acute hemodynamic response to dual-site LV CRT. Two LV pacing leads were successfully implanted in 12 CRT candidates (New York Heart Association classes III to IV, QRS >or=120 ms). Target positions were the lateral or posterolateral vein (site A) and anterior or anterolateral vein (site B). A conductance catheter was placed in the left ventricle for pressure-volume measurements. Tested CRT configurations were alternated by atrial overdrive pacing at a fixed rate and included site A and B single-site CRT and dual-site LV CRT (2 LV sites plus right ventricular apex) at 4 atrioventricular intervals. Overall, single-site LV CRT significantly enhanced stroke volume, stroke work, maximum pressure derivative, and conductance-derived indexes of LV synchrony when delivered in site A, whereas no significant changes were noticed with pacing in site B. Specifically, site-A pacing resulted in a higher stroke volume increase (LV pacing site associated with the best hemodynamic response [best-LV]) in 8 patients, and site-B pacing, in 4 patients. At intermediate atrioventricular intervals, dual-site LV CRT resulted in improved stroke volume, stroke work, maximum pressure derivative, and LV synchrony with respect to single-site CRT when delivered at the best-LV (all p <0.05). However, single-site CRT at best-LV produced results similar to dual-site LV CRT when the atrioventricular interval was optimized in each patient. In conclusion, adding a second LV lead does not result in further improvement in acute hemodynamic response with respect to standard CRT when the single LV pacing site and atrioventricular interval are optimal.

Major predictors of fibrous adherences in transvenous implantable cardioverter-defibrillator lead extraction

BACKGROUND Percutaneous removal of implantable cardioverter-defibrillator (ICD) leads is a difficult procedure because of the consequence of massive fibrous tissue growth along the lead. OBJECTIVE The purpose of this study was to describe the occurrence and location of fibrous adherences in ICD lead extraction and to identify potential predictors among patient and lead characteristics. METHODS We studied 637 consecutive patients who underwent transvenous extraction of 678 ICD leads from 1997 to 2013. RESULTS Procedural success rate was 99%, without major complications. Areas of adherence were found in the subclavian vein (78%), innominate vein (65%), superior vena cava (66%), and heart (73%). Dwell-time, passive fixation, and dual-coil lead design were independently associated with adherences. Dual-coil lead design was associated with adherences in the innominate vein and superior vena cava, whereas coil treatment (eg, expandable polytetrafluoroethylene-coated or medical adhesive back-filled strategies) prevented adherences. Passive fixation mechanism was associated with adherences in the heart. CONCLUSION ICD leads, after long dwell-time, are affected by fibrous adherences uniformly distributed along the lead course. Lead features represent major predictors of the phenomenon. Careful lead selection is recommended at the time of implantation to prevent adherences. In addition, lead-related risk stratification is mandatory before a transvenous extraction procedure.

Follow‐Up of CRT‐ICD: Implications for the Use of Remote Follow‐Up Systems. Data from the InSync ICD Italian Registry

Background: Launch of remote follow‐up systems in Europe is currently underway. However, there is insufficient understanding of postimplant practices with respect to device follow‐up, reprogramming of device features, and postshock clinic visits.

Heart rate variability monitored by the implanted device predicts response to CRT and long-term clinical outcome in patients with advanced heart failure

Few data exist on the long‐term changes and the prognostic value of heart rate variability (HRV) assessed by implanted devices in heart failure (HF) patients treated with resynchronization therapy (CRT).