OBJECTIVES: Transcatheter heart valves such as the self-expandable Portico valve (St. Jude Medical) are being developed to overcome limitations of first-generation devices. Since clinical experience with this valve is still limited in a real-world setting, we investigated its use on an all-comer basis. METHODS: Between October 2015 and October 2016, a total of 100 consecutive patients assessed for transcatheter aortic valve replacement (TAVR) and found suitable for the Portico valve were included. The primary endpoint was 30-day all-cause mortality. Secondary endpoints included immediate postprocedural survival, complications according to Valve Academic Research Consortium (VARC)-2 criteria, and echocardiographic findings. RESULTS: All 100 participants received a Portico valve; the patient group included 56 women (56%) and 44 men (44%) with mean age of 81.7 ± 5.1 years. Mean EuroScore II and STS scores were 6.2 ± 8.6 and 5.2 ± 6.1, respectively. Immediate postprocedural survival rate was 99%. The 30-day mortality rate (6%) was comparable with earlier studies performed in selected patients. Complications included major stroke (2%), minor stroke (2%), major vascular complication (2%), minor vascular complication (4%), cardiac tamponade (1%), major bleeding (3%), conversion into open surgery (1%), and pacemaker implantation (19.5%). Maximal and mean echocardiographic gradients were reduced from 66 mm Hg (range, 21-141 mm Hg) to 15 mm Hg (range, 4-41 mm Hg) (P<.001) and from 44 mm Hg (range, 12-84 mm Hg) to 8 mm Hg (range, 2-25 mm Hg) (P<.001), respectively. A low rate of more-than-mild paravalvular leak was observed (4.4%). CONCLUSIONS: Our immediate and 30-day post-TAVR results support favorable survival comparable to other studies, and significant clinical improvement with the Portico valve in non-selected patients in a real-world setting, with short-term complications being uncommon.
OBJECTIVES: Transcatheter heart valves such as the self-expandable Portico valve (St. Jude Medical) are being developed to overcome limitations of first-generation devices. Since clinical experience with this valve is still limited in a real-world setting, we investigated its use on an all-comer basis. METHODS: Between October 2015 and October 2016, a total of 100 consecutive patients assessed for transcatheter aortic valve replacement (TAVR) and found suitable for the Portico valve were included. The primary endpoint was 30-day all-cause mortality. Secondary endpoints included immediate postprocedural survival, complications according to Valve Academic Research Consortium (VARC)-2 criteria, and echocardiographic findings. RESULTS: All 100 participants received a Portico valve; the patient group included 56 women (56%) and 44 men (44%) with mean age of 81.7 ± 5.1 years. Mean EuroScore II and STS scores were 6.2 ± 8.6 and 5.2 ± 6.1, respectively. Immediate postprocedural survival rate was 99%. The 30-day mortality rate (6%) was comparable with earlier studies performed in selected patients. Complications included major stroke (2%), minor stroke (2%), major vascular complication (2%), minor vascular complication (4%), cardiac tamponade (1%), major bleeding (3%), conversion into open surgery (1%), and pacemaker implantation (19.5%). Maximal and mean echocardiographic gradients were reduced from 66 mm Hg (range, 21-141 mm Hg) to 15 mm Hg (range, 4-41 mm Hg) (P<.001) and from 44 mm Hg (range, 12-84 mm Hg) to 8 mm Hg (range, 2-25 mm Hg) (P<.001), respectively. A low rate of more-than-mild paravalvular leak was observed (4.4%). CONCLUSIONS: Our immediate and 30-day post-TAVR results support favorable survival comparable to other studies, and significant clinical improvement with the Portico valve in non-selected patients in a real-world setting, with short-term complications being uncommon.
Authors: Alberto Alperi; Guillem Muntané-Carol; Afonso B Freitas-Ferraz; Lucia Junquera; David Del Val; Laurent Faroux; François Philippon; Josep Rodés-Cabau Journal: Ann Cardiothorac Surg Date: 2020-11