The epidemic of inadequate biventricular pacing in patients with persistent or permanent atrial fibrillation and its association with mortality.

BACKGROUND: We classified patients' atrial fibrillation (AF), assessed its impact on biventricular pacing (BIVP%), and determined whether AF classification or BIVP% independently correlate with mortality in cardiac resynchronization therapy defibrillator patients. METHODS AND RESULTS: Cardiac resynchronization therapy defibrillator patients were classified as permanent (daily mean AF burden ≥23 hours), persistent (≥7 consecutive days of AF ≥23 hours/d), paroxysmal (≥1 day with AF ≥6 hours), or no/little AF (all others) using device-detected AF during the 6 months postimplant. We evaluated subsequent all-cause mortality using a multivariable Cox proportional hazard regression. Among 54 019 patients (age, 70±11 years; 73% male; follow-up, 2.3±1.2 years), 8% of patients each had permanent (N=4449), persistent (N=4237), and paroxysmal AF (N=4219). A high proportion of patients with permanent (69%) and persistent (62%) AF did not achieve high BIVP (>98%). Relative to no/little AF, patients with AF had increased mortality after adjusting for age, sex, BIVP, and shocks (permanent: hazard ratio=1.28 [1.19-1.38]; P<0.001; persistent: hazard ratio=1.51 [1.41-1.61]; P<0.001). Relative to patients with BIVP >98%, patients with reduced BIVP had increased mortality after adjusting for age, sex, AF, and shocks (90%-98%: hazard ratio=1.20 [1.15-1.26]; P<0.001; <90%: hazard ratio=1.32 [1.23-1.41]; P<0.001). High BIVP% was associated with the greatest mortality improvement in permanent AF among the AF classifications. CONCLUSIONS: High BIVP% was not achieved in two thirds of 8686 patients with persistent or permanent AF, and these patients had an increased risk of death. A shift toward more aggressive rate control and more pacing may be necessary in patients with AF to maximize the benefits of cardiac resynchronization therapy.

Transvenous extraction of implantable cardioverter-defibrillator leads under advisory--a comparison of Riata, Sprint Fidelis, and non-recalled implantable cardioverter-defibrillator leads.

BACKGROUND: Comparative safety and efficacy associated with transvenous lead extraction (TLE) of recalled and non-recalled implantable cardioverter-defibrillator (ICD) leads has not been well characterized. OBJECTIVES: To compare the indications, techniques, and procedural outcomes of recalled vs non-recalled ICD lead extraction procedures. METHODS: TLE procedures performed at our institution from June 2002 to June 2012 in which Riata, Sprint Fidelis, or non-recalled ICD leads were extracted were included in the analysis. RESULTS: ICD lead extraction procedures were performed in 1079 patients, including 430 patients with recalled leads (121 Riata, 308 Sprint Fidelis, and 1 Riata and Sprint Fidelis) and 649 patients with non-recalled ICD leads. A total of 2056 chronic endovascular leads were extracted, of which 1215 (59.1%) were ICD leads. Overall, there was 96.8% complete procedural success, 99.1% clinical success, and 0.9% failure, with 3.9% minor complications and 1.5% major complications. Procedural outcomes for Riata and Sprint Fidelis TLE procedures were no different. Lead implant duration was significantly less in recalled than in non-recalled ICD lead TLE procedures. Complete procedural success was higher in recalled (424 of 430 [98.6%]) than in non-recalled (621 of 649 [95.7%]; P = .007) ICD lead TLE procedures. Minor complications were lower in recalled (10 of 430 [2.3%]) than in non-recalled (32 of 649 [5.0%]; P = .030) ICD lead TLE procedures. Rates of clinical success, failure, and major complications were no different in the recalled and non-recalled ICD lead TLE procedures. CONCLUSION: In our experience, recalled ICD leads were extracted with safety and efficacy comparable to that of non-recalled ICD leads.

Use of dabigatran for periprocedural anticoagulation in patients undergoing catheter ablation for atrial fibrillation.

BACKGROUND: Pulmonary vein isolation (PVI) for atrial fibrillation is associated with a transient increased risk of thromboembolic and hemorrhagic events. We hypothesized that dabigatran can be safely used as an alternative to continuous warfarin for the periprocedural anticoagulation in PVI. METHODS AND RESULTS: A total of 999 consecutive patients undergoing PVI were included; 376 patients were on dabigatran (150 mg), and 623 patients were on warfarin with therapeutic international normalized ratio. [corrected] Dabigatran was held 1 to 2 doses before PVI and restarted at the conclusion of the procedure or as soon as patients were transferred to the nursing floor. Propensity score matching was applied to generate a cohort of 344 patients in each group with balanced baseline data. Total hemorrhagic and thromboembolic complications were similar in both groups, before (3.2% versus 3.9%; P=0.59) and after (3.2% versus 4.1%; P=0.53) matching. Major hemorrhage occurred in 1.1% versus 1.6% (P=0.48) before and 1.2% versus 1.5% (P=0.74) after matching in the dabigatran versus warfarin group, respectively. A single thromboembolic event occurred in each of the dabigatran and warfarin groups. Despite higher doses of intraprocedural heparin, the mean activated clotting time was significantly lower in patients who held dabigatran for 1 or 2 doses than those on warfarin. CONCLUSIONS: Our study found no evidence to suggest a higher risk of thromboembolic or hemorrhagic complications with use of dabigatran for periprocedural anticoagulation in patients undergoing PVI compared with uninterrupted warfarin therapy.

Pacemaker and ICD leads: strategies for long-term management.

Pacemaker and defibrillator therapy is on the rise as a result of expanding indications. Unfortunately, this trend is associated with an increased number of cardiac device-related complications. Lead failure, device infection and vascular complication are not uncommon and may cause significant patient morbidity and mortality. Furthermore, the considerable variability in the approach to dealing with device-related complications not infrequently leads to additional problems and complications. This review is intended to provide general guidelines and strategies for long-term management of cardiac devices. Proper implantation techniques that focus on primary prevention of complications, as well as, planning for future procedures are essential. The use of sterile techniques and implementation of peri-operative antibiotics are well supported in clinical trials. Additionally, minimizing the amount of implanted hardware and limiting the procedure length have also been shown to decrease the rates of infectious complications. Once device infection is confirmed, the primary objective, short of a few exceptions, should consist of the entire system removal via open surgery or percutaneously and antibiotic therapy before reimplantation. Vascular occlusions are not uncommon; however, in the majority of cases they are asymptomatic. Nonetheless, they pose a significant problem with device reimplantation, especially in the younger patients who will require multiple generator exchanges in the future. Site preservation should, therefore, become the primary objective. This can also be accomplished with the open surgical or percutaneous device removal. The latter is very safe and effective when performed in experienced centers. Finally, lead follow-up must be routinely conducted to identify problematic leads, prevent further reimplantations, and guide future research.