RESUMEN
BACKGROUND: The Diamondback 360® Coronary Orbital Atherectomy System (Cardiovascular Systems Inc., St. Paul, MN) is the first and only orbital atherectomy system approved by the US FDA for the treatment of severely calcified lesions. While the device has proven to be safe in clinical trials, real-world data are minimal. METHODS: The Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports on the Diamondback 360® Coronary from January 2019 to January 2022. RESULTS: A total of 566 events were reported during the study period. After the exclusion of duplicate reports, the final cohort included 547 reports. The most common mode of failure was break or separation of a device part (40.4%, n = 221) mainly due to breaking in the tip of the ViperWire (66.1%), driveshaft (22.7%), or crown (12.2%). The most common vessel associated with events was the left anterior descending artery (31.4%), followed by the right coronary artery (26.9%), left circumflex (21.6%), and left main coronary artery (6.4%). The most common clinical adverse outcome was perforation (33.0%, n = 181) with 23.7% resulting in cardiac tamponade. Most perforation cases were treated by covered stent (44.2%), surgery (30.5%), stent (98%), and balloon angioplasty (9%). There were 89 (16.3%) events of death with 67% due to perforation (p < 0.001). CONCLUSION: Our study provided a glimpse of real-world adverse outcomes and common modes of failure due to orbital atherectomy. The most common mode of failure was the break or separation of a device part and the most common complication was perforation according to the MAUDE database. It will help physicians to anticipate complications and escalate care appropriately.
RESUMEN
Background: The Turnpike catheters (Teleflex, Wayne, PA, USA) is a microcatheter that was approved by the Food and Drug Administration in November 2014 to be used to access discrete regions of the coronary and peripheral vasculature. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of the Turnpike catheters from March 2015 through August 2021. Results: A total of 216 reports were found during the study period. After excluding duplicate reports (n = 21), our final cohort included 195 reports. The most common failure mode was catheter tip break or detachment (83%, n = 165) which was significantly associated with over-torquing (p-value = 0.025). The most common clinical consequence was the entrapment of the catheter (33%, n = 65), followed by vessel injury (7.8% n = 15) and vessel occlusion (3.6%, n = 7). Most patients had no consequences (47.0%, n = 93) or recovered (11%, n = 22). A total of 4 deaths were reported. 35.8% of reports (n = 69) specified the presence of severe calcification in the target vessel. Over torquing by interventionists was reported in 33.2% of events (n = 64). Conclusion: Despite clinical trials demonstrating the safety of the Turnpike catheters, complications can still occur. These data serve to inform operators about potentional risks and complications associated with the use of the device. Physicians should avoid over-torqueing which seems to be the most common mechanism for device complications.
RESUMEN
Valgus subtrochanteric osteotomy is the standard surgical treatment for coxa vara. Nevertheless, there is no consensus on the method of fixation and osteotomy technique. There are some reports on employing rigid internal fixation methods that preclude the need of postoperative immobilization. This is a technical description of a valgus osteotomy performed using external fixation with preoperative and postoperative data on a cohort of 9 patients. In this study, 9 hips in 9 patients with the diagnosis of developmental coxa vara underwent a subtrochanteric osteotomy with stabilization by an external fixator. The planned correction angle was obtained for all 9 patients with the osteotomies healing primarily. Radiographic analysis showed an improvement in Hilgenreiner's epiphyseal angle and the neck-shaft angle. There were no major complications associated with use of this method of stabilization. Minimal access surgery using external fixation for a valgus osteotomy of the proximal femur is safe and effective for the treatment for coxa vara and limb length discrepancy. It has potential advantages over commonly used open techniques and provides available alternative to currently applied methods used for fixation of proximal femoral osteotomies.
