Symptom Severity and Health-Related Quality of Life in Patients with Atrial Fibrillation: Findings from the Observational ARENA Study.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with impaired health-related quality of life (HRQoL), high symptom severity, and poor cardiovascular outcomes. Both clinical and psychological factors may contribute to symptom severity and HRQoL in AF. METHODS: Using data from the observational Atrial Fibrillation Rhine-Neckar Region (ARENA) trial, we identified medical and psychosocial factors associated with AF-related symptom severity using European Heart Rhythm Association symptom classification and HRQoL using 5-level EuroQoL- 5D. RESULTS: In 1218 AF patients (mean age 71.1 ± 10.5 years, 34.5% female), female sex (OR 3.7, p < 0.001), preexisting coronary artery disease (CAD) (OR 1.7, p = 0.020), a history of cardioversion (OR 1.4, p = 0.041), cardiac anxiety (OR 1.2; p < 0.001), stress from noise (OR 1.4, p = 0.005), work-related stress (OR 1.3, p = 0.026), and sleep disturbance (OR 1.2, p = 0.016) were associated with higher AF-related symptom severity. CAD (ß = -0.23, p = 0.001), diabetes mellitus (ß = -0.25, p < 0.001), generalized anxiety (ß = -0.30, p < 0.001), cardiac anxiety (ß = -0.16, p < 0.001), financial stress (ß = -0.11, p < 0.001), and sleep disturbance (ß = 0.11, p < 0.001) were associated with impaired HRQoL. CONCLUSIONS: Psychological characteristics, preexisting CAD, and diabetes may play an important role in the identification of individuals at highest risk for impaired HRQoL and high symptom severity in patients with AF.

Six-year outcomes of anterior lumbar interbody arthrodesis with use of interbody fusion cages and recombinant human bone morphogenetic protein-2.

BACKGROUND: Twenty-four-month outcomes have been reported for patients with degenerative lumbar disc disease who were treated with stand-alone anterior lumbar interbody arthrodesis with use of dual tapered interbody fusion cages and recombinant human bone morphogenetic protein-2. This report represents an update of the clinical and radiographic results of this treatment at six years. METHODS: Two hundred and seventy-seven patients with single-level degenerative disc disease with up to grade-I spondylolisthesis were enrolled in two prospective, multicenter, U.S. Food and Drug Administration-approved investigational device exemption studies and were treated with an open or a laparoscopic surgical procedure. The patients received recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge with lumbar fusion cage implants. One hundred and forty-six patients completed the six-year clinical follow-up evaluations, and 130 patients had complete radiographic follow-up at six years. Outcomes were determined with use of well-established clinical outcome measurements (Oswestry Disability Index, Short Form-36, and back and leg pain scores) and radiographic assessments. RESULTS: At six years, 128 (98%) of the 130 patients treated with recombinant human bone morphogenetic protein-2 and stand-alone fusion cages had a fusion. The second surgery rate was 6.7% (eighteen patients) prior to two years and 3.7% (seven patients) from two to six years. A worst-case scenario analysis, which includes all second surgical procedures due to pseudarthrosis, resulted in a fusion rate at seventy-two months of 91% (128 of 141). Significant improvements in the Oswestry Disability Index scores, Short Form-36 health survey physical component summary scores, and back and leg pain scores were achieved by six weeks in both the open and laparoscopic groups and were sustained at six years (p < 0.001). The percentage of patients who were working at six months (63%) was higher than the percentage who had been working preoperatively (52%), and this improvement was sustained at six years (68%). CONCLUSIONS: The use of dual tapered threaded fusion cages and recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge obtained and maintained intervertebral spinal fusion, improved clinical outcomes, and reduced pain after anterior lumbar interbody arthrodesis in patients with degenerative lumbar disc disease.

Laparoscopic anterior lumbar interbody fusion at L4-L5: an anatomic evaluation and approach classification.

STUDY DESIGN: An anatomic classification system was devised on the basis of operative reports and preoperative magnetic resonance imaging or computerized tomography from 139 patients who underwent laparoscopic anterior lumbar interbody fusion involving L4-L5. OBJECTIVE: To devise a classification system for laparoscopic exposure of the L4-L5 disc space that would allow prediction of the safest approach for any given vascular configuration. SUMMARY OF BACKGROUND DATA: The laparoscopic technique has gained acceptance at L5-S1 but has been less successful at L4-L5. The vascular bifurcation and the variability of the anatomy have led to difficulties with exposure. METHODS: Data were collected on 139 patients undergoing laparoscopic anterior lumbar interbody fusion involving the L4-L5 disc space. Operative notes and preoperative magnetic resonance imaging and computed tomography scans were reviewed, and a classification system was devised based on the aortic bifurcation and confluence of the left iliac vein with the vena cava. Three variations were identified. Complications, particularly ejaculatory dysfunction, were described. RESULTS: Three classification categories were described. Twenty-five patients (18%) were classified as category A (above the bifurcation of both vessels), 52 patients (37%) were classified as category B (below the bifurcation of both vessels), and 51 patients (37%) were classified as category C (between the left iliac artery and vein). There were 8 (5.8%) intraoperative and 17 (12.2%) postoperative complications. Ejaculatory dysfunction constituted the majority of the postoperative complications, representing 16% of the male population. The incidence of ejaculatory dysfunction correlated with exposure from the left side of the aorta or the left iliac artery. For two-level fusions from L4 to S1, the incidence of ejaculatory dysfunction was 63% for category A but 0% for categories B and C. An alternative approach was suggested for category A: exposing the disc space between the aorta and vena cava. CONCLUSION: The laparoscopic approach to L4-L5 is complicated by the variability of the vascular anatomy encountered during the exposure. Routine magnetic resonance imaging or computed tomography can be used to classify the vascular anatomy and plan the optimal approach. Avoiding the left side of the aorta or the left iliac artery may minimize the risk of ejaculatory dysfunction.