Pre-emptive thoracic endovascular aortic repair is unnecessary in extended type A (DeBakey type I) aortic dissections.

OBJECTIVE: Pre-emptive thoracic endovascular aortic repair (TEVAR) improves late survival and limits progression of disease after type B aortic dissection, but the potential value of pre-emptive TEVAR has not been evaluated after type A dissection extending beyond the aortic arch (DeBakey type I). The purpose of this study was to compare disease progression and need for aortic intervention in survivors of acute, extended type A (ExTA) dissections after initial repair of the ascending aorta versus acute type B aortic dissections. METHODS: Consecutive patients presenting with ExTA or type B dissections between 2011 and 2018 were studied. Forty-three patients with ExTA and 44 with type B dissections who survived to discharge and had follow-up imaging studies were included in the analysis. Study end points included progression of aortic disease (>5 mm growth or extension), need for intervention, and death. RESULTS: The groups were not different for age, sex, atherosclerotic risk factors, or extent of dissection distal to the left subclavian artery. Following emergent ascending aortic repair, five ExTA patients (12%) underwent TEVAR within 4 months after discharge. Despite optimal medical treatment, 29 type B patients (66%) underwent early or late TEVAR (P < .001). During a mean follow-up of 38 ± 30 months, 38 ExTA patients (88%) did not require intervention-23 (53%) of whom showed no disease progression. In comparison, during a mean follow-up of 18 ± 6 months, 14 type B patients (32%) did not require intervention-nine (20%) of whom showed no disease progression (P = .003). There was one aortic-related late death in the ExTA group and two in the type B group. Compared with ExTA patients, type B patients had significantly worse intervention-free survival and intervention/growth-free survival (log rank, P < .001). CONCLUSIONS: In contrast with type B dissections, these midterm results demonstrate that one-half of ExTA aortic dissections show no disease progression in the thoracic or abdominal aorta, and few require additional interventions. After initial repair of the ascending aorta, pre-emptive TEVAR does not seem to be justified in patients with acute, ExTA dissections.

Development of a Classification Scheme for Examining Adverse Events Associated with Medical Devices, Specifically the DaVinci Surgical System as Reported in the FDA MAUDE Database.

OBJECTIVE: To examine the Manufacturer and User Facility Device Experience Database (MAUDE) database to capture adverse events experienced with the Da Vinci Surgical System. In addition, to design a standardized classification system to categorize the complications and machine failures associated with the device. SUMMARY BACKGROUND DATA: Overall, 1,057,000 DaVinci procedures were performed in the United States between 2009 and 2012. Currently, no system exists for classifying and comparing device-related errors and complications with which to evaluate adverse events associated with the Da Vinci Surgical System. METHODS: The MAUDE database was queried for events reports related to the DaVinci Surgical System between the years 2009 and 2012. A classification system was developed and tested among 14 robotic surgeons to associate a level of severity with each event and its relationship to the DaVinci Surgical System. Events were then classified according to this system and examined by using Chi-square analysis. RESULTS: Two thousand eight hundred thirty-seven events were identified, of which 34% were obstetrics and gynecology (Ob/Gyn); 19%, urology; 11%, other; and 36%, not specified. Our classification system had moderate agreement with a Kappa score of 0.52. Using our classification system, we identified 75% of the events as mild, 18% as moderate, 4% as severe, and 3% as life threatening or resulting in death. Seventy-seven percent were classified as definitely related to the device, 15% as possibly related, and 8% as not related. Urology procedures compared with Ob/Gyn were associated with more severe events (38% vs 26%, p < 0.0001). Energy instruments were associated with less severe events compared with the surgical system (8% vs 87%, p < 0.0001). Events that were definitely associated with the device tended to be less severe (81% vs 19%, p < 0.0001). CONCLUSIONS: Our classification system is a valid tool with moderate inter-rater agreement that can be used to better understand device-related adverse events. The majority of robotic related events were mild but associated with the device.