The Wolverine cutting balloon (CB) (Boston Scientific) is a specialized balloon catheter with microsurgical blades that is used for balloon-resistant lesions. The Manufacturer and User Facility Device Experience (MAUDE) database serves as a repository for reports of medical device complications. The aim of this study was to analyze complications associated with CB use during percutaneous coronary intervention in real-world contemporary practice. The MAUDE database was searched from January 1, 2020 through December 31, 2023 for reports of complications associated with CB use. Data from individual reports were extracted for analysis. The final analysis included 2278 complications, of which 97.3% (n = 2216) were associated with device malfunction, 2.4% (n = 55) were associated with patient injury, and 0.3% (n = 7) were associated with patient death. The most common complication overall was balloon rupture (n = 1847), while the most common complication associated with patient injury or death was device entrapment (n = 33). The median number of inflations was significantly higher for complications associated with patient injury or death (3 [IQR 1-8]) compared with complications associated with device malfunction (1[IQR 1-2]) (P = .0035). The median maximum inflation pressure was significantly higher for complications associated with patient injury or death (12 [IQR 11-15] atm) compared with complications associated with device malfunction (8 [IQR 6-10] atm) (P = .0001). Overall, 2.7% of reported complications were associated with patient injury or death. The most common complication overall was balloon rupture. Device entrapment was the most common complication among reports associated with patient injury or death. Higher inflation pressures and greater number of inflations may be associated with adverse outcomes.
Abstract Background The effect of utilizing transapical (TA) access for transcatheter aortic valve replacement (TAVR) on cardiac function has not been well studied. Aims The aim of this retrospective study is to determine the direct effects of TA access for TAVR on myocardial function parameters and their correlation with 4‐year survival. Methods Three hundred and thirty propensity matched patients, who underwent TAVR using Sapien valve (Edwards Lifesciences Corp, Irvine, CA) between February 15, 2012 and June 17, 2016 (115 TA and 115 transfemoral [TF] routes) were studied. The pre‐ and 1 month post‐TAVR echocardiographic features of both groups were compared. The 4‐year survival in both groups was analyzed. Results Baseline clinical characteristics, diastolic function parameters, left ventricular (LV) chamber size, and ejection fraction were similar between matched TA and TF groups. At 1 month following TAVR, there was a significant increase in stroke volume index (SVI) in both TA (mean increase 7 cm 3 /m 2 ; P = 0.03) and TF groups (mean increase 7 cm 3 /m 2 ; P < 0.001). Left ventricular ejection fraction (LVEF) significantly increased post TF TAVR (mean increase 2%; P = 0.008), but no significant increase was observed post TA TAVR (mean increase 1%; P = 0.27). Both groups had significant improvement in aortic valve (AV) hemodynamics post‐TAVR ( P < 0.001). Overall, there were no significant differences in the mean change of SVI, LVEF, or left ventricular end diastolic dimensions (LVEDDs) post TA versus TF TAVR. There was no significant difference in 4‐year survival in the TF compared to TA group (49% vs 50%, P = 0.43). Conclusion Both TA and TF TAVR were equally associated with favorable changes in LV SVI and AV hemodynamics in 30 days. TA TAVR patients had similar 4 year survival to propensity matched TF TAVR; therefore, TA TAVR remains an acceptable alternative access route in patients not amenable to TF TAVR.
Contemporary direct ("fully percutaneous") transaxillary (TAx) large-bore arterial access technique advocates for a 0.018" wire to be passed from femoral arterial access to axillary artery to serve percutaneous bailout options. However, in certain patients, avoiding femoral arterial access entirely may be desired. We describe the merits of a "fully upper extremity" (FUE) bailout approach, as a refinement to previously described direct TAx technique.
