Saad, Marwan

AbstractBackgroundThere is a paucity of data regarding the sex‐related differences in the trends and outcomes of trans‐septal transcatheter mitral valve replacement (TS‐TMVR).MethodsThe Nationwide Readmissions Database (2015–2018) was queried for admissions for TS‐TMVR. Propensity matched analysis was conducted to compare outcomes with hospitalizations for TS‐TMVR among women versus men. The main study outcome was in‐hospital mortality.ResultsOur final analysis included 2063 hospitalizations for TS‐TMVR; of whom, 58.1% were women. The proportion of women among those undergoing TS‐TMVR increased from 50% in 2015 to 60.2% in 2018 (Ptrend = 0.04). Compared with men, women undergoing TS‐TMVR were slightly younger, and had a distinct profile of comorbidities. After matching, there was no significant difference in in‐hospital mortality among women versus men undergoing TS‐TMVR (7.8% vs. 6.1%, OR = 1.30; 95% CI: 0.79–2.13). Subgroup analyzes showed an interaction toward higher mortality with women versus men among patients with CKD (Pinteraction = 0.07). There were no significant differences between women and men in in‐hospital complications or length of stay after TS‐TMVR. Compared with men, women undergoing TS‐TMVR were more likely to be discharged to a nursing facility (17.7% vs. 11.5%, p = 0.01) and had higher rates of 30‐day readmissions (22.4% vs. 13.6%, p = 0.01).ConclusionThis nationwide analysis showed an increase in the proportion of women among patients undergoing TS‐TMVR during the study years. There were no differences in in‐hospital mortality, in‐hospital complications, or length of stay between both sexes following TS‐TMVR. Women were more likely to be discharged to nursing facilities and had higher rates of readmission at 30 days even after propensity matching.

AbstractBackgroundThere is a paucity of literature on safety and efficacy of various transseptal puncture (TSP) needles.ObjectivesTo assess the reported mechanisms of failure, complications, and outcomes among the most frequently used transseptal needles in the United States.MethodsWe queried the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and January 2021 for reports on the most commonly used transseptal needles: NRG (Baylis Medical, Montreal, Canada), and BRK (St. Jude, Saint Paul, MN)]. The primary outcome was the mechanism of failure. Secondary outcomes included clinical consequences of device failure.ResultsThe final analysis included 306 reports of failure/complication with TSP needles (NRG n = 70, BRK n = 236). The most commonly reported mode of failure was detachment of the needle component (i.e., clip, hub, stopcock, shaft, spring, or needle tip) (14.7% overall; 17.8% BRK; and 4.3% NRG). Among these reports, cardiac perforation was the most common complication (69.9% overall; 69.1% for BRK; and 72.9% for NRG). Pericardiocentesis was the second most commonly reported complication (45.1% overall; 48.3% for BRK; and 34.3% for NRG). The procedure was successfully completed in 33.3% of all cases (36.4% for BRK and 22.9% for NRG), while surgical conversion was needed in (13.4% overall; 14% for BRK and 11.4% for NRG) of the reports. Death occurred in 3.9% of all cases overall (3.4% for BRK and 5.7% for NRG).ConclusionsNeedle detachment was the most common mode of failure, and cardiac perforation was the most common complication reported with TSP needles. Future efforts should focus on innovative TSP needle design, best practice guidelines, including role of imaging guidance, and increased TSP training.

AbstractObjectiveThe authors aimed to investigate the benefits and risks of catheter‐directed thrombolysis (CDT) in acute deep venous thrombosis (DVT).BackgroundThe role of CDT in the management of DVT is evolving. Data on CDT versus anticoagulation alone in acute DVT is sparse.MethodsWe performed a systematic review and meta‐analysis of published studies that compared CDT to anticoagulation alone in patients with acute DVT.ResultsWe included 11 studies (four randomized control trials [RCTs] and seven observational studies) with a total of 8,737 patients. During hospital stay, patients who received CDT had higher odds of major bleeding (2.5% vs. 1.6%; OR 1.46, 95% CI [1.07, 1.98], p = .02), blood transfusion (10.8% vs. 6.2%; OR 1.8, 95% CI [1.52, 2.13], p < .001), and thromboembolism (15.5% vs. 10%; OR 1.67, 95% CI [1.47, 1.91], p < .001) compared with anticoagulation alone. At 6‐month follow‐up, patients who received CDT had higher venous patency (71.1% vs. 37.7%; OR 5.49, 95% CI [2.63, 11.5], p < .001) and lower postthrombotic syndrome (PTS; 27% vs. 40.7%; OR 0.44, 95% CI [0.22, 0.86], p = .02). During a mean follow‐up duration of 30.5 ± 28 months, CDT group continued to have higher venous patency (79.6% vs. 71.8%; OR 3.79, 95% CI [1.54, 9.32], p = .004) and lower PTS (44.7% vs. 50.5%; OR 0.43, 95% CI [0.23, 0.78], p = .006), but no difference in thromboembolism.ConclusionCompared with anticoagulation alone, CDT for patients with acute DVT was associated with a higher risk of complications, but a higher rate of venous patency and lower risk of postthrombotic syndrome at 2.5 years follow‐up.

Background: Radial access (RA) is increasingly used in chronic total occlusion (CTO) percutaneous coronary intervention with encouraging results. However, there are concerns about its safety and efficacy because of higher complexity and the need for strong guide catheter support. Methods and Results: We performed a systematic review and meta-analysis of all studies published through November 2018 reporting the outcomes of RA versus femoral access in CTO percutaneous coronary intervention. Outcomes included major bleeding, access-site complications, in-hospital major adverse events, and technical success. Nine observational studies with 10 590 patients (10 617 lesions) were included in the meta-analysis. CTO lesions attempted using RA had lower Japan-CTO score (2.3±1.2 versus 2.5±1.3; P <0.001). Use of RA was associated with similar technical success (78.7% versus 78.5%; odds ratio, 1.11; 95% CI, 0.94–1.31; P =0.24; I 2 =23%), lower risk of access-site complications (0.73% versus 1.79%; odds ratio, 0.34; 95% CI, 0.22–0.51; P <0.001; I 2 =0%) and major bleeding (0.18% versus 0.9%; odds ratio, 0.22; 95% CI, 0.10–0.45; P <0.001; I 2 =0%), and similar risk of in-hospital adverse events and in-hospital mortality (odds ratio, 0.36; 95% CI, 0.12–1.07; P =0.07; I 2 =0%) as compared to femoral access. Results were similar when analyzing radial-only versus any femoral access and when excluding the largest study. Conclusions: As compared with femoral access, RA is used in CTO percutaneous coronary intervention of less complex lesions and is associated with fewer access-site complications and major bleeding and comparable technical success.