A comparison of bleeding complications post-ablation between warfarin and dabigatran.

INTRODUCTION: Although warfarin has traditionally been used for reducing risk of stroke in patients with atrial fibrillation, over the past year, the direct thrombin inhibitor dabigatran has become an accepted alternative. No study has conclusively investigated bleeding risks of patients treated with dabigatran immediately following radiofrequency catheter ablation (RFCA) procedures. METHODS: We evaluated 156 consecutive patients referred for RFCA of atrial arrhythmias: 31 patients were on dabigatran and 125 patients were on warfarin. The incidence of bleeding complications during the first 48 h and the first week following ablation were recorded and comparisons made using Fisher's exact test. Major complications were defined as hemorrhage requiring blood products or the need for vascular intervention. Minor complications were defined as prolonged bleeding from the catheter insertion site, hematoma formation, or development of ecchymosis. Our study also took into account the intraprocedure activated clotting time (ACT) levels in an effort to describe any differences between both patient groups. RESULTS: There were no differences in age, gender, procedure type, or level of intraprocedural anticoagulation between the warfarin and dabigatran groups. No major bleeding complications were observed in either patient group at either 48 h or 1 week postprocedure. Six of the 31 dabigatran patients and 21 of the 125 warfarin patients had minor bleeding complications. There was no statistically significant difference between the incidence of minor bleeding complications between the two groups (p = 0.7384), although rebleeding was more commonly observed in patients on dabigatran. In regard to the intraprocedure ACT levels, there was more variability in the dabigatran patient group, and it was more difficult to achieve the goal ACT level, yet these results did not affect overall bleeding complications. CONCLUSION: In our cohort, bleeding-related complications 48 h and 1 week post-ablation were similar for warfarin and dabigatran. Dabigatran is associated with more intraprocedural variability in ACT than warfarin.

Late toxicity after postprostatectomy salvage radiation therapy.

PURPOSE: To evaluate late toxicity in patients who received salvage external beam radiotherapy (EBRT) for a detectable prostate-specific antigen (PSA) level after radical prostatectomy (RP). METHODS: A cohort of 308 consecutive patients underwent salvage EBRT from July 1987 through June 2003 for a detectable PSA level after RP. All were treated with high-energy photons (6-20 MV) to a median dose of 64.8 Gy (range: 54.0-72.4 Gy) in 1.8- to 2.0-Gy fractions. RESULTS: Median follow-up from the completion of EBRT was 60 months (range: 1 day-174 months). Late toxicity occurring more than 90 days after EBRT completion was identified in 41 patients (13%). Twelve patients (3.9%) had grade 2 urethral strictures and were treated with urethral dilation, 3 patients had grade 3 cystitis, and 1 had a grade 4 rectal complication. These numbers correspond to an estimated 0.7% (95% confidence interval, 0.0-1.6%) of patients experiencing a grade 3 or 4 complication by 5 years after the start of EBRT. CONCLUSIONS: Salvage EBRT for a detectable PSA level after RP is the only curative treatment in this setting. This treatment can be administered in a manner that results in a low likelihood of late complications.

Radiofrequency catheter ablation of atrial fibrillation in older patients: outcomes and complications.

INTRODUCTION: Catheter ablation (CA) of atrial fibrillation (AF) has become a treatment option for younger patients with drug refractory AF. It is not known whether pulmonary veins (PV) have an important mechanistic role in elderly patients with AF or whether CA is an effective treatment for the elderly. METHODS: We evaluated 240 consecutive patients that were referred to the electrophysiology laboratory for CA for AF using a PV antral isolation approach. Linear ablations were not routinely performed. Clinical outcomes and healthcare resource utilization was evaluated during the 12 months after CA in patients <65 years old (Group 1; 91 patients), 65-75 years old (Group II; 88 patients), and >75 years old (Group III; 61 patients). RESULTS: Older patients were more likely to have persistent atrial fibrillation (I: 24%, II: 34%, III: 66%). Major complication rates (I: 1%; II: 1%; III: 0%; p=ns) and minor complication rates (I: 4%; II: 5%; III: 5%; p=ns) were similar for all three groups. At 12 month follow-up younger patients were more likely to be in sinus rhythm without prolonged episodes of atrial fibrillation without antiarrhythmic drug therapy (AARx) (I: 94%, II: 84%, III: 61%). However in Group III, effective treatment (AF <1 h/mo +/- AARx) was achieved in 82% of patients. After radiofrequency catheter ablation, hospitalizations, emergency room and nonroutine clinic visits decreased significantly for all three groups during the 12 months after RFA (I: pre 22; post: 3; Group II: pre 26; post 4; III: pre 20; post 2). CONCLUSIONS: CA can be effective for treating AF in selected older patients as stand-alone therapy or as hybrid therapy with AARx. PVs appear to be an important arrhythmogenic structure regardless of age. CA is associated with decreased healthcare resource utilization in all age groups.

Combined prostate brachytherapy and short-term androgen deprivation therapy as salvage therapy for locally recurrent prostate cancer after external beam irradiation.

PURPOSE: We describe the treatment outcome in 17 patients who received combined salvage brachytherapy and short-term androgen deprivation therapy for local prostate cancer relapse after prior external beam irradiation. MATERIALS AND METHODS: Median patient age was 68 years. Local relapse after external beam irradiation was confirmed by biopsy. Median prostate specific antigen at local relapse was 4.7 ng/ml. Five of the 17 patients were enrolled in a protocol combining androgen deprivation therapy with brachytherapy and the remaining men were treated off protocol. All patients received neoadjuvant androgen deprivation therapy for a median of 3 months, followed by ultrasound guided brachytherapy using 125I in 9 and 103Pd seeds in 8. Five patients also received adjuvant leuprolide for a median of 6 months. Biochemical failure was defined using the American Society for Therapeutic Radiology and Oncology definition. Toxicity was graded with a modified Radiation Therapy Oncology Group scale. RESULTS: Median followup was 44 months. The actuarial 4-year biochemical control rate was 75%. Three patients died of intercurrent diseases. No prostate cancer mortality or local failure had occurred at last followup. One patient had bone metastasis. No clinical or treatment factor was associated with biochemical control. Grade 3 and 4 genitourinary toxicity developed in 7 (41%) and 1 patients (6%), respectively. Grade 2 and 3 gastrointestinal toxicity occurred in 5 (29%) and 1 patients (6%), respectively. CONCLUSIONS: Our series suggests that salvage brachytherapy and short-term androgen deprivation therapy can achieve biochemical control in select patients with local relapse after prior external beam irradiation. The major side effects are urinary complications, including grade 3 and 4 complications in 41% and 6% of cases, respectively.

Salvage radiotherapy for isolated prostate specific antigen increase after radical prostatectomy: evaluation of prognostic factors and creation of a prognostic scoring system.

PURPOSE: This study was performed to evaluate the results and prognostic factors associated with radiotherapy for a detectable serum prostate specific antigen level after radical prostatectomy. MATERIALS AND METHODS: From July 1987 through July 2003, 368 patients received radiotherapy for a detectable prostate specific antigen level (biochemical relapse) as the sole evidence of recurrence after radical prostatectomy for node negative prostate cancer. Estimated survival and relapse-free probabilities were obtained via Kaplan-Meier estimation. Associations of patient factors with survival and biochemical relapse were investigated using Cox proportional hazards models. RESULTS: With a median followup of 5 years the 5 and 8-year freedom from biochemical relapse were an estimated 46% (95% CI 41%-53%) and 35% (95% CI 29%-43%) while survival was 92% (95% CI 89%-95%) and 80% (95% CI 74%-87%), respectively. Patient and treatment variables showing evidence of association with biochemical relapse on multivariate analysis included pathological stage T3a or less vs T3b (seminal vesicle involvement, p = 0.029), pathological Gleason score 7 or less vs 8 or greater (p <0.001) and pre-radiotherapy prostate specific antigen (p <0.001). Four biochemical failure risk groups were created by assigning seminal vesicle involvement, Gleason score and pre-radiotherapy prostate specific antigen each a score of 0 to 2. These individual scores were summed. The freedom from biochemical failure at 5 years for each risk group was 0 to 1-69%, 2-53%, 3-26% and 4 to 5-6%. CONCLUSIONS: The presence of seminal vesicle involvement and high Gleason score in the radical prostatectomy specimen are inherent predictors of adverse outcome. Early referral for salvage radiotherapy can decrease subsequent biochemical relapse.