BACKGROUND: The conventional thoracic endovascular aortic repair (TEVAR) involves groin incisions under general or epidural anesthesia. As technology moves towards less invasive procedures, a total percutaneous approach is desirable. In this study, we describe a Preclosing technique and investigate its safety and efficacy for femoral access sites management, and evaluate its advantages as compared to those of traditional surgical cutdown approaches. METHODS: The Preclosing technique involves two or multiple 6 F Perclose Proglide devices deployed in the femoral artery before upsizing to a 20-25 F sheath. The sutures were secured to close the arteriotomy at the end of the procedure. The medical records of patients who underwent thoracic endovascular aortic repairs using the Preclosing technique between December 2009 and November 2010 (group A) were compared with those using surgical femoral cutdown from January 2008 to November 2009 (group B). Outcome measures included rates of technical success, early complications, anesthesia method, procedure time, cardiac care unit (CCU) stay, time from procedure to discharge, hospital stay, procedure expense, hospital cost. RESULTS: Between the two groups, there were no significant differences in baseline characteristics, in the endograft models or profiles. The technical success rate was 100.0% (85/85) in group A vs. 97.4% (147/151) in group B (P < 0.05). There was no access-related mortality in both groups. Compared with group B, the incidence of early complications were fewer in group A, 9.4% (8/85) vs. 22.5% (34/151) (P < 0.01). Local anesthesia with conscious sedation was used more often in group A, 68.2% (58/85) vs. 51.7% (78/151) in group B (P < 0.01). The procedure duration was shorter, (96 ± 33) minutes in group A vs. (127 ± 41) minutes in group B (P < 0.01). The length of the CCU stay, the duration from procedure to discharge, and the hospital stay were both reduced in group A, (117.3 ± 88.3) hours, (7.5 ± 5.3) days and (15.3 ± 6.8) days vs. (132.7 ± 115.5) hours, (10.5 ± 5.0) days and (19.5 ± 7.8) days in group B (P < 0.01). The procedure cost was RMB (109,000 ± 30,000) Yuan in group A vs. RMB (108,000 ± 25,000) Yuan in group B (P = NS). The hospital cost was RMB (130,000 ± 35,000) Yuan in group A vs. RMB (128,000 ± 33,000) Yuan in group B (P = NS). CONCLUSIONS: Total percutaneous TEAVR with the Preclosing technique is safe and effective with meticulous technique and appropriate patient selection. The Preclosing technique decreases access-related complications, depends less on general anesthesia and the surgeon's cooperation, saves procedure time and shortens the CCU/hospital stay. With these advantages, the use of two percutaneous closure devices increases the hospital cost only slightly.
BACKGROUND: The conventional thoracic endovascular aortic repair (TEVAR) involves groin incisions under general or epidural anesthesia. As technology moves towards less invasive procedures, a total percutaneous approach is desirable. In this study, we describe a Preclosing technique and investigate its safety and efficacy for femoral access sites management, and evaluate its advantages as compared to those of traditional surgical cutdown approaches. METHODS: The Preclosing technique involves two or multiple 6 F Perclose Proglide devices deployed in the femoral artery before upsizing to a 20-25 F sheath. The sutures were secured to close the arteriotomy at the end of the procedure. The medical records of patients who underwent thoracic endovascular aortic repairs using the Preclosing technique between December 2009 and November 2010 (group A) were compared with those using surgical femoral cutdown from January 2008 to November 2009 (group B). Outcome measures included rates of technical success, early complications, anesthesia method, procedure time, cardiac care unit (CCU) stay, time from procedure to discharge, hospital stay, procedure expense, hospital cost. RESULTS: Between the two groups, there were no significant differences in baseline characteristics, in the endograft models or profiles. The technical success rate was 100.0% (85/85) in group A vs. 97.4% (147/151) in group B (P < 0.05). There was no access-related mortality in both groups. Compared with group B, the incidence of early complications were fewer in group A, 9.4% (8/85) vs. 22.5% (34/151) (P < 0.01). Local anesthesia with conscious sedation was used more often in group A, 68.2% (58/85) vs. 51.7% (78/151) in group B (P < 0.01). The procedure duration was shorter, (96 ± 33) minutes in group A vs. (127 ± 41) minutes in group B (P < 0.01). The length of the CCU stay, the duration from procedure to discharge, and the hospital stay were both reduced in group A, (117.3 ± 88.3) hours, (7.5 ± 5.3) days and (15.3 ± 6.8) days vs. (132.7 ± 115.5) hours, (10.5 ± 5.0) days and (19.5 ± 7.8) days in group B (P < 0.01). The procedure cost was RMB (109,000 ± 30,000) Yuan in group A vs. RMB (108,000 ± 25,000) Yuan in group B (P = NS). The hospital cost was RMB (130,000 ± 35,000) Yuan in group A vs. RMB (128,000 ± 33,000) Yuan in group B (P = NS). CONCLUSIONS: Total percutaneous TEAVR with the Preclosing technique is safe and effective with meticulous technique and appropriate patient selection. The Preclosing technique decreases access-related complications, depends less on general anesthesia and the surgeon's cooperation, saves procedure time and shortens the CCU/hospital stay. With these advantages, the use of two percutaneous closure devices increases the hospital cost only slightly.
Authors: Bastiaan P Vierhout; Ben R Saleem; Alewijn Ott; Jan Maarten van Dijl; Ties D van Andringa de Kempenaer; Maurice E N Pierie; Jan T Bottema; Clark J Zeebregts Journal: Trials Date: 2015-09-14 Impact factor: 2.279