R. Hardwin Mead

Long-term outcome with the automatic implantable cardioverter-defibrillator

The automatic implantable cardioverter-defibrillator was implanted in 270 patients because of life-threatening arrhythmias over a 7 year period. There was a history of sustained ventricular tachycardia or fibrillation, or both, in 96% of these patients, 80% had one or more prior cardiac arrests and 78% had coronary artery disease as their underlying diagnosis. The average ejection fraction was 34%, and 96% of these patients had had an average of 3.4 antiarrhythmic drug failures per patient before defibrillator implantation. There were four perioperative deaths and eight patients had generator infection or generator erosion, or both, during the perioperative period or during long-term follow-up. Concomitant antiarrhythmic drug therapy was given to 69% of patients. Shocks from the device were given to 58% of patients. and 20% received problematic shocks. The device was removed from 16 patients during long-term follow-up for a variety of reasons. There were 7 sudden cardiac deaths and 30 nonsudden cardiac deaths, 18 of which were secondary to congestive heart failure. The actuarial incidence of sudden death, total cardiac death and total mortality from all causes was 1%, 7% and 8%, respectively, at 1 year, and 4%, 24% and 26% at 5 years. The automatic implantable cardioverter-defibrillator nearly eliminates sudden death over a long-term follow-up period in a high risk group of patients. It has an acceptable rate of complications or problems, or both, and most late deaths in these patients are nonsudden and of cardiovascular origin.

The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) Trial: The Value of Wireless Remote Monitoring With Automatic Clinician Alerts

OBJECTIVESnThe primary objective was to determine if wireless remote monitoring with automatic clinician alerts reduces the time from a clinical event to a clinical decision in response to arrhythmias, cardiovascular (CV) disease progression, and device issues compared to patients receiving standard in-office care. A secondary objective was to compare the rates of CV health care utilization between patients in the remote and in-office arms.nnnBACKGROUNDnIn addition to providing life-saving therapy, implantable cardioverter-defibrillators collect advanced diagnostics on the progression of the patients heart disease. Device technology has progressed to allow wireless remote monitoring with automatic clinician alerts to replace some scheduled in-office visits.nnnMETHODSnThe CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) study was a multicenter, prospective, randomized evaluation involving 1,997 patients from 136 clinical sites who underwent insertion of an implantable cardioverter-defibrillator (including cardiac resynchronization therapy devices) and were followed up for 15 months. Health care utilization data included all CV-related hospitalizations, emergency department visits, and clinic office visits.nnnRESULTSnThe median time from clinical event to clinical decision per patient was reduced from 22 days in the in-office arm to 4.6 days in the remote arm (p < 0.001). The health care utilization data revealed a decrease in mean length of stay per CV hospitalization visit from 4.0 days in the in-office arm to 3.3 days in the remote arm (p = 0.002).nnnCONCLUSIONSnWireless remote monitoring with automatic clinician alerts as compared with standard in-office follow-up significantly reduced the time to a clinical decision in response to clinical events and was associated with a significant reduction in mean length of CV hospital stay. (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision [CONNECT]; NCT00402246).

Remote monitoring of implantable cardioverter defibrillators: a prospective analysis.

A prospective study evaluating the functionality and ease of use of the Medtronic CareLink® Network, “CareLink,” was conducted at ten investigational sites. This internet‐based remote monitoring service allows clinicians to remotely manage their patients implantable cardioverter defibrillators (ICDs) and chronic diseases. The network is comprised of a patient monitor, a secure server, and clinician and patient websites. Under clinician direction, patients interrogated their ICDs at home, and transmitted data to secure servers via a standard telephone line. Comprehensive device data and a 10‐second presenting rhythm electrogram were captured by the monitor and available for access and review on the clinician website. The information could also be printed using a standard desktop computer with internet access. During this study, patients were asked to transmit device data twice, at least 7 days apart, as scheduled by the clinic. Monitor functionality was assessed, and ease of using the system components was evaluated via questionnaires completed by patients and clinicians following each data transmission and review. Fifty‐nine patients (64 ± 14 years, range 22‐85 years) completed 119 transmissions with only 14 calls to the study support center. Clinician review of data transmissions revealed several clinically significant findings, including silent AF discovery, assessment of antiarrhythmic drug efficacy in a previously diagnosed AF patient, previously unobserved atrial undersensing, and ventricular tachycardia. ICD patients found the monitor easy to use. Clinicians were pleased with the performance of the network and the quality of the web‐accessed data, and found it comparable to an in‐office device interrogation. CareLink is a practical tool for routine device management and may allow timely identification of clinically important issues. (PACE 2004; 27[Pt. I]:757–763)

The use of dabigatran immediately after atrial fibrillation ablation.

Dabigatran After AF Ablation. Introduction: Atrial fibrillation (AF) ablation requires postprocedural anticoagulation to prevent thromboembolic events because of the ablation procedure itself or due to recurrent AF postprocedure. Dabigatran is a new anticoagulant and may be useful after AF ablation to prevent thromboembolic events.

Clinical experience with sotalol in patients with drug-refractory ventricular Arrhythmias

Sixty-five patients with symptomatic, drug-refractory, sustained ventricular tachycardia or fibrillation were treated with oral sotalol (80 to 480 mg twice daily). Sotalol was withdrawn in 11 patients because of continued inducibility of ventricular tachycardia at the time of follow-up electrophysiologic study. Therefore, the clinical effectiveness of sotalol could be evaluated in 54 patients followed up for 11.5 +/- 6 months (range 0.2 to 25). The actuarial incidence of successful sotalol therapy was 54 +/- 13% at 6 months and 47 +/- 13% at 12 months. In 39 patients who underwent electrophysiologic testing while receiving oral sotalol, the drug prevented the reinduction of ventricular tachycardia/fibrillation in 8 (20%). During follow-up study, arrhythmia recurred in 1 (17%) of 6 patients whose ventricular tachycardia was noninducible with oral sotalol and in 8 (44%) of 18 with inducible tachycardia but who were continued on oral sotalol therapy. Adverse effects were noted in 28 patients (42%), requiring drug withdrawal in 13 (22%) and dose reduction after hospital discharge in 10 (15%). Exacerbation of ventricular arrhythmia occurred in six patients (9%), one of whom had associated hypokalemia. Sotalol is frequently useful in the control of intractable, life-threatening ventricular arrhythmias, and its efficacy appears to be predicted by programmed stimulation. However, there is a high rate of limiting side effects, which precludes its use in a large number of patients, and a substantial risk of arrhythmia exacerbation.

The NASPE /BPEG Defibrillator Code

A new generic code, patterned after and compatible with the NASPE/BPEG Generic Pacemaker Code (NBG Code) was adopted by the NASPE Board of Trustees on January 23. 1993. It was developed by the NASPE Mode Code Committee, including members of the North American Society of Pacing and Electrophysiology (NASPE) and the British Pacing and Electrophysiology Croup (BPEC). It is abbreviated as the NBD (for NASPE/BPEC Defibrillator) Code. It is intended for describing the capabilities and operation of implanted cardioverter defibrillators (ICDs) in conversation, record keeping, and device labeling, and incorporates four positions designating: (1) shock location; (2) antitachycardia pacing location; (3) means of tachycardia detection; and (4) antibradycardia pacing location. An additional Short Form, intended only for use in conversation, was defined as a concise means of distinguishing devices capable of shock alone, shock plus antibradycardia pacing, and shock plus antitachycardia and antibradycardia pacing.

Comparison of defibriliation efficacy in humans using a new catheter and superior vena cava spring-left ventricular patch electrodes

The automatic implantable cardioverter-defibrillator currently utilizes an electrode system that requires a major operation for implantation. Effective defibrillation using an implantable cardioverter-defibrillator catheter positioned transvenously would eliminate the morbidity associated with such surgery. Fifteen patients undergoing defibrillator implantation were studied to compare the efficacy of the catheter with that of the superior vena cava spring (6.7 cm2, anode)-left ventricular patch (13.5 cm2, cathode) electrode system using truncated exponential waveforms with 60% tilt. The catheter is 11F in diameter and tripolar. A distal platinum-iridium tip used for pacing was separated by 4 mm from a middle 4.3 cm2 platinum electrode; these were positioned at the right ventricular apex. The proximal 8.5 cm2 platinum electrode was situated at the superior vena cava-right atrial junction. Defibrillation was performed using the middle (cathode) and proximal (anode) electrodes. Ventricular fibrillation was induced by alternating current six times, and defibrillation shocks of 1, 5, 10, 15, 20 or 25 J were given in random order, first using the catheter and then the spring-patch system. Rescue shocks of higher energy were given if there was failure. Although very low energy levels appeared to be slightly more efficacious when using the spring-patch system, there was no statistically significant difference between the electrode systems for any of the energies tested. Permanent implantation of the catheter would have been suitable in 45% of the patients, as compared with 54% of patients with the spring-patch system (p = NS).(ABSTRACT TRUNCATED AT 250 WORDS)

Long-term results of atrial fibrillation ablation: the importance of all initial ablation failures undergoing a repeat ablation.

BACKGROUNDnAblation is more successful for patients with paroxysmal atrial fibrillation (AF1) than for those with persistent (AF2) or longstanding persistent AF (AF3). Many patients fail initial ablation and undergo repeat ablations. Little is known about repeat ablation procedure times, complications, and outcomes.nnnMETHODSnWe evaluated Kaplan-Meier freedom from AF by AF type and sex for initial and repeat ablations and for final status of 843 patients undergoing 1122 ablations. We examined complications, procedure times and reasons why patients do not undergo repeat ablations. Cox multivariate analysis evaluated factors predicting ablation failure.nnnRESULTSnInitial ablations were more successful in AF1 than AF2 or AF3 (P < .0001) patients. For each AF type, repeat ablations were more successful than initial ablations (P = .01 to <.001). Procedure times (139.1 ± 49.1 vs 135.3 ± 45.6 minutes, P = .248) and major complications (1.66% vs 2.87%, P = .216) were similar. Women had different clinical characteristics than men, similar initial and repeat ablation success rates but lower overall success because of fewer repeat ablations (57.8% vs 68.2%, P = .047) due to patient choice (P = .028). Patients with either successful initial ablations or undergoing repeat ablations had late AF recurrence rates of 0% to 1.5% a year. Age (P = .012), larger left atria (P = .002), female sex (P = .001), AF2 (P < .0001), AF3 (P = .003), and coronary disease (P = .003) predicted failure.nnnCONCLUSIONSnRepeat ablations are more successful than initial ablations, have similar procedure times and complication rates, help determine final success rates, and may explain sex difference in success rates. For the best outcomes, patients should assume that a repeat ablation may be required to eliminate AF.

Peri-procedural interrupted oral anticoagulation for atrial fibrillation ablation: comparison of aspirin, warfarin, dabigatran, and rivaroxaban

Aims Atrial fibrillation ablation requires peri-procedural oral anticoagulation (OAC) to prevent thromboembolic events. There are several options for OAC. We evaluate peri-procedural AF ablation complications using a variety of peri-procedural OACs. Methods and results We examined peri-procedural OAC and groin, bleeding, and thromboembolic complications for 2334 consecutive AF ablations using open irrigated-tip radiofrequency (RF) catheters. Pre-ablation OAC was warfarin in 1113 (47.7%), dabigatran 426 (18.3%), rivaroxaban 187 (8.0%), aspirin 472 (20.2%), and none 136 (5.8%). Oral anticoagulation was always interrupted and intraprocedural anticoagulation was unfractionated heparin (activated clotting time, ACT = 237 ± 26 s). Pre- and post-OAC drugs were the same for 1591 (68.2%) and were different for 743 (31.8%). Following ablation, 693 (29.7%) were treated with dabigatran and 291 (12.5%) were treated with rivaroxaban. There were no problems changing from one OAC pre-ablation to another post-ablation. Complications included 12 (0.51%) pericardial tamponades [no differences for dabigatran (P = 0.457) or rivaroxaban (P = 0.163) compared with warfarin], 12 (0.51%) groin complications [no differences for rivaroxaban (P = 0.709) and fewer for dabigatran (P = 0.041) compared with warfarin]. Only 5 of 2334 (0.21%) required blood transfusions. There were two strokes (0.086%) and no transient ischaemic attacks (TIAs) in the first 48 h post-ablation. Three additional strokes (0.13%), and two TIAs (0.086%) occurred from 48 h to 30 days. Only one stroke had a residual deficit. Compared with warfarin, the neurologic event rate was not different for dabigatran (P = 0.684) or rivaroxaban (P = 0.612). Conclusion Using interrupted OAC, low target intraprocedural ACT, and irrigated-tip RF, the rate of peri-procedural groin, haemorrhagic, and thromboembolic complications was extremely low. There were only minimal differences between OACs. Low-risk patients may remain on aspirin/no OAC pre-ablation. There are no problems changing from one OAC pre-ablation to another post-ablation.

The use of a radiofrequency needle improves the safety and efficacy of transseptal puncture for atrial fibrillation ablation

BACKGROUNDnAtrial fibrillation (AF) ablation requires transseptal puncture to gain entry to the left atrium (LA). On rare occasions, LA entry cannot be achieved or cardiac perforation results in pericardial tamponade.nnnOBJECTIVEnThis study sought to compare a new radiofrequency (RF) transseptal needle with the standard needle.nnnMETHODSnWe evaluated 1,550 AF ablations in 1,167 patients. We compared 975 transseptal punctures done using a standard needle to 575 done using a new electrode-tipped needle attached to an RF perforation generator.nnnRESULTSnThe rate of failure to cross the atrial septum was lower for the RF needle (1 of 575 [0.17%] vs. 12 of 975 [1.23%], P = .039) and there were fewer pericardial tamponades with the RF needle (0 of 575 [0.00%] vs. 9 of 975 [0.92%], P = .031). Multivariate analysis showed the RF needle use was the only variable associated with a lower incidence of tamponade (P = .04). Becasuse the RF needle was used later in our series, we examined our 975 standard needle punctures over time for evidence of improved operator experience that might explain the superior RF results. For the standard needle, there was no trend for improved septal crossing rates (P = .794) or fewer tamponades (P = .456) with more operator experience. Instrumentation time was shorter for the RF needle (27.1 ± 10.9 vs. 36.4 ± 17.7 minutes, P < .0001).nnnCONCLUSIONnOur data suggest that the RF needle is superior to the standard transseptal needle. It results in shorter instrumentation times, a greater efficacy in transseptal crossing, and fewer episodes of pericardial tamponade.