Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity) Trial: Results at 1 Year.

Background Bariatric embolization is a new endovascular procedure to treat patients with obesity. However, the safety and efficacy of bariatric embolization are unknown. Purpose To evaluate the safety and efficacy of bariatric embolization in severely obese adults at up to 12 months after the procedure. Materials and Methods For this prospective study (NCT0216512 on ClinicalTrials.gov ), 20 participants (16 women) aged 27-68 years (mean ± standard deviation, 44 years ± 11) with mean body mass index of 45 ± 4.1 were enrolled at two institutions from June 2014 to February 2018. Transarterial embolization of the gastric fundus was performed using 300- to 500-µm embolic microspheres. Primary end points were 30-day adverse events and weight loss at up to 12 months. Secondary end points at up to 12 months included technical feasibility, health-related quality of life (Short Form-36 Health Survey ([SF-36]), impact of weight on quality of life (IWQOL-Lite), and hunger or appetite using a visual assessment scale. Analysis of outcomes was performed by using one-sample t tests and other exploratory statistics. Results Bariatric embolization was performed successfully for all participants with no major adverse events. Eight participants had a total of 11 minor adverse events. Mean excess weight loss was 8.2% (95% confidence interval [CI]: 6.3%, 10%; P < .001) at 1 month, 11.5% (95% CI: 8.7%, 14%; P < .001) at 3 months, 12.8% (95% CI: 8.3%, 17%; P < .001) at 6 months, and 11.5% (95% CI: 6.8%, 16%; P < .001) at 12 months. From baseline to 12 months, mean SF-36 scores increased (mental component summary, from 46 ± 11 to 50 ± 10, P = .44; physical component summary, from 46 ± 8.0 to 50 ± 9.3, P = .15) and mean IWQOL-Lite scores increased from 57 ± 18 to 77 ± 18 (P < .001). Hunger or appetite decreased for 4 weeks after embolization and increased thereafter, without reaching pre-embolization levels. Conclusion Bariatric embolization is well tolerated in severely obese adults, inducing appetite suppression and weight loss for up to 12 months. Published under a CC BY-NC-ND 4.0 license. Online supplemental material is available for this article.

Predictors of Late-Onset Atrial Fibrillation Following Isolated Mitral Valve Repairs in Patients With Preserved Ejection Fraction.

BACKGROUND: We sought to determine the incidence of and risk factors for late-onset atrial fibrillation (LOAF) in patients with preserved ejection fractions undergoing mitral valve repair METHODS: We included patients undergoing isolated mitral valve repair (MVR) for degenerative disease between 1997-2014 at our institution with EF ≥60%. Patients who had AF preoperatively were excluded from the final analysis. Our primary outcome, LOAF, was defined as AF occurring after discharge following MVR (≥9 days). RESULTS: 223 patients were included in the study with a mean follow-up of 4.8 ± 4.6 years. A total of 25 patients developed LOAF, and freedom from LOAF was 93.9% at one year, and 87.3% at five years. Patients developing LOAF were of similar mean age (58 vs. 63 years in controls, p = 0.08) and had similar preoperative comorbidities, but did show a trend toward larger left atrial diameter (5.1 vs. 4.7 cm, p = 0.11). After risk adjustment with Cox regression analysis, only increasing left atrial size was associated with LOAF (HR 1.63, p = 0.04). On follow-up, 29 patients (10.8%) developed moderate or greater mitral regurgitation at a mean of 2.2 years. Using a mixed-effects model, we were unable to detect an association between recurrent mitral regurgitation following MVR and LOAF (OR 1.36, p = 0.42). CONCLUSIONS: LOAF occurs in about 13% of preserved ejection fraction patients undergoing MVR by five years. Increasing left atrial diameter is an independent predictor of LOAF. Concomitant anti-arrhythmic procedures may warrant further investigation in patients with preserved ejection fraction and enlarged left atria undergoing MVR. doi: 10.1111/jocs.12774 (J Card Surg 2016;31:486-492).

Attributable harm of severe bleeding after cardiac surgery in hemodynamically stable patients.

BACKGROUND: We sought to quantify the effect of severe postoperative bleeding in hemodynamically stable patients following cardiac surgery. METHODS: We reviewed the charts of all cardiac surgery patients operated on at our institution between 2010 and 2014. After excluding patients with tamponade or MAP <60, we propensity matched patients having chest tube output >300 mL in the first postoperative hour, >200 mL in the second, and >100 mL in the third ("bleeding" group) with patients having <50 mL/h of chest tube output ("dry" group). The primary outcome was a composite of morbidity or mortality (excluding reexploration). RESULTS: 5016 patients were operated on between 2010 and 2014; of these, we included the records of 84 bleeding and 498 dry patients. Propensity matching resulted in 68 pairs of patients well-matched on baseline and operative variables. As compared to matched dry patients, bleeding patients were more likely to experience the primary outcome of any morbidity/mortality (36.8 vs. 13.2 %, p = 0.002), as well as ventilation >24 h (33.8 vs. 7.4 %, p < 0.001) and 30-day mortality (11.8 vs. 1.5 %, p = 0.02). Of the 84 bleeding patients, 46 underwent reexploration for bleeding within 24 h of surgery. A subgroup analysis propensity matching bleeding patients who were or were not reexplored <24 h demonstrated similarly poor outcomes in each group (primary outcome, 44.7 % reexplored vs. 50.0 % non-reexplored, p = 0.65), though reexplored patients were far less likely to require hematoma evacuation/washout >24 h after surgery (0 vs. 18.4 %, p = 0.005). CONCLUSIONS: Even among hemodynamically stable patients, severe bleeding is associated with markedly worse outcomes following cardiac surgery.