Avi Fischer

Trends in Use and Adverse Outcomes Associated with Transvenous Lead Removal in the United States

Background— Transvenous lead removal (TLR) has made significant progress with respect to innovation, efficacy, and safety. However, limited data exist regarding trends in use and adverse outcomes outside the centers of considerable experience for TLR. The aim of our study was to examine use patterns, frequency of adverse events, and influence of hospital volume on complications. Methods and Results— Using the Nationwide Inpatient Sample, we identified 91 890 TLR procedures. We investigated common complications including pericardial complications (hemopericardium, cardiac tamponade, or pericardiocentesis), pneumothorax, stroke, vascular complications (consisting of hemorrhage/hematoma, incidents requiring surgical repair, and accidental arterial puncture), and in-hospital deaths described with TLR, defining them by the validated International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code. We specifically assessed in-hospital death (2.2%), hemorrhage requiring transfusion (2.6%), vascular complications (2.0%), pericardial complications (1.4%), open heart surgery (0.2%), and postoperative respiratory failure (2.4%). Independent predictors of complications were female sex and device infections. Hospital volume was not independently associated with higher complications. There was a significant rise in overall complication rates over the study period. Conclusions— The overall complication rate in patients undergoing TLR was higher than previously reported. Female sex and device infections are associated with higher complications. Hospital volume was not associated with higher complication rates. The number of adverse events in the literature likely underestimates the actual number of complications associated with TLR.

Patients treated with catheter ablation for ventricular tachycardia after an ICD shock have lower long-term rates of death and heart failure hospitalization than do patients treated with medical management only

BACKGROUND Ventricular arrhythmias in patients with implantable cardioverter-defibrillators (ICDs) adversely affect outcomes. Antiarrhythmic approaches to ventricular tachycardia (VT) have variable efficacy and may increase risk of ventricular arrhythmias, worsening cardiomyopathy, and death. Comparatively, VT ablation is an alternative approach that may favorably affect outcomes. OBJECTIVE To further explore the effect on long-term outcomes after catheter ablation of VT, we compared patients with history of ICD shocks who did not undergo ablation, patients with a history of ICD shocks that underwent ablation, and patients with ICDs who had no history of ICD shocks. METHODS A total of 102 consecutive patients with structural heart disease who underwent VT ablation for recurrent ICD shocks were compared with 2088 patients with ICDs and no history of appropriate shocks and 817 patients with ICDs and a history of appropriate shocks for VT or ventricular fibrillation. Outcomes considered were mortality, heart failure hospitalization, atrial fibrillation, and stroke/transient ischemic attack. RESULTS The mean age of 3007 patients was 65.4 ± 13.9 years. Over long-term follow-up, 866 (28.8%) died, 681 (22.7%) had a heart failure admission, 706 (23.5%) developed new-onset atrial fibrillation, and 224 (7.5%) had a stroke. The multivariate-adjusted risks of deaths and heart failure hospitalizations were higher in patients with history of ICD shocks who were treated medically than in patients with ICDs and no history of shock (hazard ratio [HR] 1.45; P < .0001 vs HR 2.00; P < .0001, respectively). The multivariate-adjusted risks were attenuated after VT ablation with death and heart failure hospitalization rates similar to those of patients with no shock (HR 0.89; P = .58 vs HR 1.38; P = .09, respectively). A similar nonsignificant trend was seen with stroke/transient ischemic attack. CONCLUSIONS Patients treated with VT ablation after an ICD shock have a significantly lower risk of death and heart failure hospitalization than did patients managed medically only. The adverse event rates after VT ablation were similar to those of patients with ICDs but without VT.

Contribution of ethylenetetrafluoroethylene (ETFE) insulation to the electrical performance of Riata® silicone leads having externalized conductors.

BackgroundThe insulation of St. Jude Medical Riata® leads contains a polytetrafluoroethylene (PTFE) liner, silicone tubing, and ethylenetetrafluoroethylene (ETFE) coating on individual cable conductors. ETFE has sufficient dielectric strength to assure electrical function. This investigation intended to analyze performance of leads with and without externalized conductors and with intact and breached ETFE.MethodsTesting was performed on ETFE-coated conductors to determine their ability to deliver high-voltage therapy. Tests were performed on samples under different conditions and current leakage was measured. A high-voltage test and a cyclic pulse test were performed, and the effect of lead modifications on the potential gradient from a high-voltage shock was used to determine functionality. Measurements from modified Riata® leads were compared with a control lead with all insulation and conducting elements intact.ResultsCurrent leakage for all conditions tested, was within the acceptance criteria for the high-voltage test and the cyclic pulse test. In conductors that underwent cyclic testing, the highest value of current leakage was within the limit of acceptability for both phases of the test. Testing of leads with externalized conductors and breached ETFE showed similar potential gradients compared with a control lead.ConclusionsTesting of ETFE-coated conductors following multiple preconditioning steps showed that ETFE serves as a redundant layer of insulation. In the event that the ETFE coating is breached, the potential gradient seen resulting from a high-voltage defibrillation shock was similar to a lead with no breach to the ETFE, even after 100 shocks.

Additional electrodes on the Quartet™ LV lead provide more programmable pacing options than bipolar and tripolar equivalents

Aims The aim of this study was to evaluate any benefits to the number of viable pacing vectors and maximal spatial coverage with quadripolar left ventricular (LV) leads when compared with tripolar and bipolar equivalents in patients receiving cardiac resynchronization therapy (CRT). Methods and Results A meta-analysis of five previously published clinical trials involving the Quartet™ LV lead (St Jude Medical, St Paul, MN, USA) was performed to evaluate the number of viable pacing vectors defined as capture thresholds ≤2.5 V and no phrenic nerve stimulation and maximal spatial coverage of viable vectors in CRT patients at pre-discharge (n = 370) and first follow-up (n = 355). Bipolar and tripolar lead configurations were modelled by systematic elimination of two and one electrode(s), respectively, from the Quartet lead. The Quartet lead with its four pacing electrodes exhibited the greatest number of pacing vectors per patient when compared with the best bipolar and the best tripolar modelled equivalents. Similarly, the Quartet lead provided the highest spatial coverage in terms of the distance between two furthest viable pacing cathodes when compared with the best bipolar and the best tripolar configurations (P < 0.05). Among the three modelled bipolar configurations, the lead configuration with the two most distal electrodes resulted in the highest number of viable pacing vectors. Among the four modelled tripolar configurations, elimination of the second proximal electrode (M3) resulted in the highest number of viable pacing options per patient. There were no significant differences observed between pre-discharge and first follow-up analyses. Conclusion The Quartet lead with its four electrodes and the capability to pace from four anatomical locations provided the highest number of viable pacing vectors at pre-discharge and first follow-up visits, providing more flexibility in device programming and enabling continuation of CRT in more patients when compared with bipolar and tripolar equivalents.

The Evolution of the Cardiac Implantable Electronic Device Connector

Cardiac implantable electronic devices (CIEDs) play a vital role in the management of cardiac rhythm disturbances. The devices are comprised of two primary components: a generator and lead joined by a connector. Original pacemaker lead connectors were created de novo at the time of implantation or replacement and were very unreliable. With the development of new lead designs, creation of a standard connector configuration, the IS‐1 connector became mandatory. Similar connector development also occurred with the advent of the implantable cardioverter defibrillator (ICD), resulting in creation of the high voltage standard: the DF‐1 connector. Differing from a pacemaker lead, the ICD lead connector requires one IS‐1 connector and one or two DF‐1 connectors, resulting in a large cumbersome lead connector and generator header block. Recently, a revolutionary quad pole single plug connector standard has been approved for market release. These are the single‐pin DF4 and IS4 lead connectors that carry low‐ and high‐voltage poles or all low‐voltage poles, respectively. These connectors, together with new labeling guidelines, have simplified operative procedures and reduced errors, when mating lead connectors into the generators connector block.