Clinical Outcome of Transcatheter Aortic Valve Replacement With TriGUARD 3™ Cerebral Embolic Protection Device.

OBJECTIVE: Periprocedural stroke during transcatheter aortic valve replacement (TAVR) is a highly feared adverse event. The TriGUARD 3 cerebral embolic protection device (CEPD) may have the potential benefit of reduction of embolic events, but it still remains unclear whether it reduces the incidence of periprocedural stroke or transient ischemic attack (TIA). We aimed to investigate whether the latest TriGUARD 3 CEPD reduces the incidence of clinically overt stroke within 72 h or at discharge after TAVR. METHODS: In this prospective single-center study 117 patients (mean age 80.3 years, 53.8 % male) were included from July 2020 to December 2021. RESULTS: The primary efficacy endpoint of this study, periprocedural clinically overt stroke or TIA, within 72 h or at discharge after TAVR with the TriGUARD 3 CEPD occurred in 1/117 pts (0.8 %). Secondary endpoints (device related issues such as life-threatening or disabling bleeding, acute kidney injury, major vascular complications) were reported in 4/117 pts (3.4 %). CONCLUSIONS: This study suggests that the use of the latest TriGUARD 3™ CEPD in transfemoral TAVR seems to be associated with a low rate of clinically overt stroke and a low rate of device related adverse events, reflecting "real world" TAVR practice. However these results should be hypothesis generating and confirmed in a large RCT.

Detection of construction errors in ex vivo coronary artery anastomoses by 13-MHz epicardial ultrasonography.

OBJECTIVE: Intraoperative detection of suboptimal coronary anastomoses allows revision before chest closure. We evaluated an epicardial 13-MHz ultrasound minitransducer as a means to detect three different coronary anastomosis construction errors. METHODS: In total, 120 internal thoracic artery-to-coronary artery anastomoses were constructed correctly (n = 60) or incorrectly (n = 60) with one technical error: suture crossover, purse-string or deep toe stitch (n = 20 each). Anastomoses were performed on ex vivo pressure-perfused porcine (96 anastomoses) and human hearts (24 anastomoses). Two blinded observers scanned and scored the anastomoses with epicardial ultrasonography. In 24 human and 24 porcine anastomoses, angiograms were made of 24 correct and 24 incorrect anastomoses and scored by two other blinded observers. Angioscopy and cast injection served as a reference. RESULTS: Overall, 119 of 120 anastomoses were accurately scored as correct or incorrect within a median of 67 seconds (8-381 seconds) by both observers (sensitivity 0.98, specificity 1.00, kappa 1.00 (1.00, 1.00, and 1.00 in angiography subset, respectively). One deep toe stitch that induced outflow corner stenosis was spotted by both observers but regarded as insignificant and thus inaccurately scored as correct. In 5 anastomoses, unintended irregularities were detected. By angiography, anastomoses were accurately scored with a sensitivity of 0.75 and a specificity of 0.81 ( P < .001 vs ultrasonography) and kappa of 0.54. Angioscopy and cast confirmed ultrasonographic findings and did not reveal irregularities other than detected by ultrasonography. CONCLUSION: Ex vivo epicardial 13-MHz ultrasonography allowed rapid and accurate evaluation of coronary anastomoses and detected technical construction errors with higher sensitivity and specificity than angiography.

Geometry assessment of coronary artery anastomoses with construction errors by epicardial ultrasound.

OBJECTIVE: There is concern about the quality of the distal anastomosis in off-pump coronary artery bypass grafting. We investigated the impact of specific construction errors on anastomotic geometry using epicardial ultrasound. METHODS: Twelve ex vivo pressure perfused porcine and five isolated post-mortem human hearts were used to construct 35 internal mammary artery to coronary artery anastomoses, either without (n = 7) or with a standardized construction error (oversutured toe, oversutured heel, cross-over or purse string; each error, n = 7). The anastomotic geometry was visualized and measured by a 13 MHz ultrasound mini-transducer. Impression cast material was used to validate anastomotic geometry. RESULTS: All 28 errors were visualized properly. Two unintended construction abnormalities were observed. In the porcine heart, the ratio of anastomotic orifice area and outflow corner area was 1.3+/-0.2 (mean+/-standard deviation) in the control group and reduced in the error groups: oversutured toe, 0.6+/-0.2 (P = 0.001 oversutured heel, 0.9+/-0.2 (P = 0.037); cross-over, 0.4+/-0.2 (P < 0.001); purse string, 0.3+/-0.2 (P < 0.001). None of the errors reduced the area of the inflow or outflow corner itself compared to the recipient coronary artery. In the human heart, all construction errors as well as wall plaque were visualized properly. In all anastomoses, ultrasound geometry corresponded to cast geometry. CONCLUSIONS: Ex vivo, epicardial 13 MHz ultrasound enabled accurate visualization and assessment of four different construction errors in the coronary anastomosis. All errors reduced the area of the anastomotic orifice, but not the inflow or outflow corner.

Robot-assisted 13 MHz epicardial ultrasound for endoscopic quality assessment of coronary anastomoses.

In totally endoscopic coronary artery bypass surgery, intra-operative assessment of anastomotic quality is needed. We evaluated the endoscopic application of epicardial ultrasound to visualize the coronary anastomosis and detect a construction error. In 8 pigs (71-78kg), 16 internal mammary artery to left anterior descending coronary artery anastomoses were constructed conventionally, either correctly (n=8) or incorrectly with a suture cross-over construction error (n=8). A 13MHz mini-transducer (15x9x6mm) was introduced through a port and manipulated by the 'da Vinci' system. The chest was re-opened and scanning repeated manually. Postoperatively, macroscopic inspection served as reference and the intra-operative ultrasound images were scored as 'correct' or 'construction error' by two blinded observers. All anastomoses were scored accurately by both observers. One anastomosis constructed to be correct was scored as construction error, due to narrowing of the outflow corner and anastomotic orifice. Ultrasound images corresponded with macroscopic inspection. Closed-chest scan time was about 1.5 times longer than open-chest scan time, 176s (88-464) (median, range) versus 125s (75-314) (P=0.01), respectively. Closed-chest epicardial 13MHz ultrasound scanning required a median of 3min and enabled discrimination between correctly and incorrectly constructed coronary anastomoses.