Transvenous pacemaker and defibrillator lead extraction is a higher risk procedure with variation in preferred technique. A frequently fatal complication of this procedure is perforation of the ...superior vena cava. We have developed a tandem femoral-superior technique that incorporates snaring of targeted leads from a femoral approach combined with use of a rotational cutting sheath advanced over the lead from the subclavian vein.
We sought to evaluate the safety and efficacy of a tandem femoral-superior approach to lead extraction.
Consecutive patients undergoing transvenous extraction of at least 1 pacemaker or defibrillator lead with implant duration ≥1 year in which a tandem femoral-superior technique was used as the initial extraction strategy were included. The registry spanned 2010-2018 and consisted of procedures performed by a single primary operator.
A total of 131 patients were included. A total of 267 leads with a mean implant duration of 9.8 years, including 90 defibrillator leads (33.7%), were targeted for extraction. No superior vena cava perforation or other vascular damage occurred. Clinical procedural success was achieved in 96.2% of cases. There were 5 major complications (3.8% of patients), with 3 being pericardial effusion requiring intervention. There were no deaths.
A tandem femoral-superior approach to lead extraction effectively eliminated superior vena cava injury. This is a safe and effective technique for transvenous lead extraction.
Dual-chamber (atrioventricular) and single-chamber (ventricular) pacing are alternative treatment approaches for sinus-node dysfunction that causes clinically significant bradycardia. However, it is ...unknown which type of pacing results in the better outcome.
We randomly assigned a total of 2010 patients with sinus-node dysfunction to dual-chamber pacing (1014 patients) or ventricular pacing (996 patients) and followed them for a median of 33.1 months. The primary end point was death from any cause or nonfatal stroke. Secondary end points included the composite of death, stroke, or hospitalization for heart failure; atrial fibrillation; heart-failure score; the pacemaker syndrome; and the quality of life.
The incidence of the primary end point did not differ significantly between the dual-chamber group (21.5 percent) and the ventricular-paced group (23.0 percent, P=0.48). In patients assigned to dual-chamber pacing, the risk of atrial fibrillation was lower (hazard ratio, 0.79; 95 percent confidence interval, 0.66 to 0.94; P=0.008), and heart-failure scores were better (P<0.001). The differences in the rates of hospitalization for heart failure and of death, stroke, or hospitalization for heart failure were not significant in unadjusted analyses but became marginally significant in adjusted analyses. Dual-chamber pacing resulted in a small but measurable increase in the quality of life, as compared with ventricular pacing.
In sinus-node dysfunction, dual-chamber pacing does not improve stroke-free survival, as compared with ventricular pacing. However, dual-chamber pacing reduces the risk of atrial fibrillation, reduces signs and symptoms of heart failure, and slightly improves the quality of life. Overall, dual-chamber pacing offers significant improvement as compared with ventricular pacing.
Dual-chamber (DDDR) pacing preserves AV synchrony and may reduce heart failure (HF) and atrial fibrillation (AF) compared with ventricular (VVIR) pacing in sinus node dysfunction (SND). However, DDDR ...pacing often results in prolonged QRS durations (QRSd) as the result of right ventricular stimulation, and ventricular desynchronization may result. The effect of pacing-induced ventricular desynchronization in patients with normal baseline QRSd is unknown.
Baseline QRSd was obtained from 12-lead ECGs before pacemaker implantation in MOST, a 2010-patient, 6-year, randomized trial of DDDR versus VVIR pacing in SND. Cumulative percent ventricular paced (Cum%VP) was determined from stored pacemaker data. Baseline QRSd <120 ms was observed in 1339 patients (707 DDDR, 632 VVIR). Cum%VP was greater in DDDR versus VVIR (90% versus 58%, P=0.001). Cox models demonstrated that the time-dependent covariate Cum%VP was a strong predictor of HF hospitalization in DDDR (hazard ratio HR, 2.99 95% CI, 1.15 to 7.75 for Cum%VP >40%) and VVIR (HR 2.56 95% CI, 1.48 to 4.43 for Cum%VP >80%). The risk of AF increased linearly with Cum%VP from 0% to 85% in both groups (DDDR, HR 1.36 95% CI, 1.09, 1.69; VVIR, HR 1.21 95% CI 1.02, 1.43, for each 25% increase in Cum%VP). Model results were unaffected by adjustment for known baseline predictors of HF hospitalization and AF.
Ventricular desynchronization imposed by ventricular pacing even when AV synchrony is preserved increases the risk of HF hospitalization and AF in SND with normal baseline QRSd.
Class 1C antiarrhythmic drugs (AAD) have been associated with harm in patients treated for ventricular arrhythmias with a prior myocardial infarction. Consensus guidelines have advocated that these ...drugs not be used in patients with stable coronary artery disease (CAD). However, long-term data are lacking to know if unique risks exist when these drugs are used for atrial fibrillation (AF) in patients with CAD without a prior myocardial infarction.
In 24,315 patients treated with the initiation of AADs, two populations were evaluated: (1) propensity-matched AF patients with CAD were created based upon AAD class (flecainide, n = 1,114, vs class-3 AAD, n = 1,114) and (2) AF patients who had undergone a percutaneous coronary intervention or coronary artery bypass graft (flecainide, n = 150, and class-3 AAD, n = 1,453). Outcomes at 3 years for mortality, heart failure (HF) hospitalization, ventricular tachycardia (VT), and MACE were compared between the groups.
At 3 years, mortality (9.1% vs 19.3%, P < .0001), HF hospitalization (12.5% vs 18.3%, P < .0001), MACE (22.9% vs 36.6%, P < .0001), and VT (5.8% vs 8.5%, P = .02) rates were significantly lower in the flecainide group for population 1. In population 2, adverse event rates were also lower, although not significantly, in the flecainide compared to the class-3 AAD group for mortality (20.9% vs 25.8%, P = .26), HF hospitalization (24.5% vs 26.1%, P = .73), VT (10.9% vs 14.7%, P = .28) and MACE (44.5% vs 49.5%, P = .32).
Flecainide in select patients with stable CAD for AF has a favorable safety profile compared to class-3 AADs. These data suggest the need for prospective trials of flecainide in AF patients with CAD to determine if the current guideline-recommended exclusion is warranted.
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Background
Atrial fibrillation (AF) significantly reduces health‐related quality of life (HRQoL), previously measured in clinical trials using patient‐reported outcomes (PROs). We examined AF PROs in ...clinical practice and their association with subsequent clinical management.
Methods
The Utah My Evaluation (mEVAL) program collects the Toronto AF Symptom Severity Scale (AFSS) in AF outpatients at the University of Utah. Baseline factors associated with worse AF symptom score (range 0–35, higher is worse) were identified in univariate and multivariable analyses. Secondary outcomes included AF burden and AF healthcare utilization. We also compared subsequent clinical management at 6 months between patients with better versus worse AF HRQoL.
Results
Overall, 1338 patients completed the AFSS symptom score, which varied by sex (mean 7.26 for males vs. 10.27 for females; p < .001), age (<65, 9.73; 65–74, 7.66; ≥75, 7.58; p < .001), heart failure (9.39 with HF vs. 7.67 without; p < .001), and prior ablation (7.28 with prior ablation vs. 8.84; p < .001). In multivariable analysis, younger age (mean difference 2.92 for <65 vs. ≥75; p < .001), female sex (mean difference 2.57; p < .001), pulmonary disease (mean difference 1.88; p < .001), and depression (mean difference 2.46; p < .001) were associated with higher scores. At 6‐months, worse baseline symptom score was associated with the use of rhythm control (37.1% vs. 24.5%; p < .001). Similar cofactors and results were associated with increased AF burden and health care utilization scores.
Conclusions
AF PROs in clinical practice identify highly‐symptomatic patients, corroborating findings in more controlled, clinical trials. Increased AFSS score correlates with more aggressive clinical management, supporting the utility of disease‐specific PROs guiding clinical practice.
Abstract
Aims
Incorporating patient-reported outcomes (PROs) into routine care of atrial fibrillation (AF) enables direct integration of symptoms, function, and health-related quality of life (HRQoL) ...into practice. We report our initial experience with a system-wide PRO initiative among AF patients.
Methods and results
All patients with AF in our practice undergo PRO assessment with the Toronto AF Severity Scale (AFSS), and generic PROs, prior to electrophysiology clinic visits. We describe the implementation, feasibility, and results of clinic-based, electronic AF PRO collection, and compare AF-specific and generic HRQoL assessments. From October 2016 to February 2019, 1586 unique AF patients initiated 2379 PRO assessments, 2145 of which had all PRO measures completed (90%). The median completion time for all PRO measures per visit was 7.3 min (1st, 3rd quartiles: 6, 10). Overall, 38% of patients were female (n = 589), mean age was 68 (SD 12) years, and mean CHA2DS2-VASc score was 3.8 (SD 2.0). The mean AFSS symptom score was 8.6 (SD 6.6, 1st, 3rd quartiles: 3, 13), and the full range of values was observed (0, 35). Generic PROs of physical function, general health, and depression were impacted at the most severe quartiles of AF symptom score (P < 0.0001 for each vs. AFSS quartile).
Conclusion
Routine clinic-based, PRO collection for AF is feasible in clinical practice and patient time investment was acceptable. Disease-specific AF PROs add value to generic HRQoL instruments. Further research into the relationship between PROs, heart rhythm, and AF burden, as well as PRO-guided management, is necessary to optimize PRO utilization.
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