European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2017
Outcomes of perventricular off-pump versus conventional closure of ventricular septal defects: a prospective randomized study.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Voitov Alexey, Omelchenko Alexander, Gorbatykh Yuriy, Zaitsev Gregory, Arkhipov Alexey, Soynov Ilya, Bogachev-Prokophiev Alexander, Karaskov Alexander
Аннотация
OBJECTIVES: Perventricular device closure (PVDC) of ventricular septal defects (VSDs) has demonstrated excellent clinical results. However, no prospective studies have compared PVDC with the conventional approach (CA).
METHODS: Between June 2012 and August 2014, 640 consecutive patients with isolated VSD were enrolled in the study, and randomized into the PVDC group ( n = 320) and the CA group ( n = 320). The mean ages were 36.2 (10; 36) months and 36.2 (10; 36) months, respectively. The average weights were 13.9 (8.1; 15.0) kg and 14.5 (6.9; 13.8) kg, respectively. The mean follow-up was 24.9 (standard deviation 1.8) months.
RESULTS: No early or late deaths occurred in either group. The procedural success rate reached 96.6% in the PVDC group, with a 3.4% conversion rate to CA. Mean procedure time was 56.9 (30; 70) min in the PVDC group and 162 (120; 180) min in the CA group ( P = 0.000). Thirteen (3.9%) patients in the CA group and only 4 (1.3%) in the PVDC group required postoperative blood transfusion in the intensive care unit ( P = 0.040). At the final follow-up, significantly more residual shunts were found in the CA group. No rhythm or conduction disorders occurred in any patient of either group.
CONCLUSIONS: According to the mid-term follow-up results, PVDC has similar efficacy to CA for VSD closure. The off-pump PVDC technique reduces blood product transfusion and the procedural time and minimizes surgical trauma while providing excellent cosmetic results.
METHODS: Between June 2012 and August 2014, 640 consecutive patients with isolated VSD were enrolled in the study, and randomized into the PVDC group ( n = 320) and the CA group ( n = 320). The mean ages were 36.2 (10; 36) months and 36.2 (10; 36) months, respectively. The average weights were 13.9 (8.1; 15.0) kg and 14.5 (6.9; 13.8) kg, respectively. The mean follow-up was 24.9 (standard deviation 1.8) months.
RESULTS: No early or late deaths occurred in either group. The procedural success rate reached 96.6% in the PVDC group, with a 3.4% conversion rate to CA. Mean procedure time was 56.9 (30; 70) min in the PVDC group and 162 (120; 180) min in the CA group ( P = 0.000). Thirteen (3.9%) patients in the CA group and only 4 (1.3%) in the PVDC group required postoperative blood transfusion in the intensive care unit ( P = 0.040). At the final follow-up, significantly more residual shunts were found in the CA group. No rhythm or conduction disorders occurred in any patient of either group.
CONCLUSIONS: According to the mid-term follow-up results, PVDC has similar efficacy to CA for VSD closure. The off-pump PVDC technique reduces blood product transfusion and the procedural time and minimizes surgical trauma while providing excellent cosmetic results.