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COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
Challenge for perceval: aortic valve replacement with small sutureless valves--a multicenter study.
Annals of Thoracic Surgery 2015 April
BACKGROUND: There is controversy concerning the performance of small aortic prostheses (size < 21). These have been associated with morbidity and mortality after aortic valve replacement (AVR) due to their increased gradient. Sutureless technology is now available but the performance of the smallest of these prostheses needs to be assessed.
METHODS: The registries of 4 European centers, including 276 consecutive patients (mean age 79.7 ± 5.2 years, 69.9% females), were reviewed in order to compare data on the smallest model of the Sorin-Perceval sutureless prosthesis (Sorin Group, Saluggia, Italy) compared with larger models. The small valve ("S" size) was inserted (S group) in 47 patients, while 229 patients had a larger one (labeled "M" and "L" by manufacturer, herein L group). Except for body surface area (1.60 ± 0.16 vs 1.78 ± 0.19 m(2), p < 0.001), there were no other relevant preoperative differences. The European system for cardiac operative risk evaluation log was 11.4 ± 6.1 versus 12.6 ± 9.6 (p = 0.28).
RESULTS: Median sternotomy was the most frequent approach (S group 87.2% vs L group 79.5%, p = 0.31). The associated procedures were similar for both groups (31.9% vs 34.5%, p = 0.87). For isolated AVR, cardiopulmonary bypass and cross-clamp times were, respectively, 49.1 ± 16.0 and 30.7 ± 9.2 minutes (S group) versus 52.6 ± 23.1 and 32.3 ± 13.6 minutes (L group) (p = 0.33 and 0.45). Hospital mortality was nil (S group) versus 2.6% (L group) (p = 0.62). At discharge, the peak-pressure-gradients were 22.7 ± 7.9 and 20.9 ± 8.4 mm Hg (p = 0.24) while indexed effective orifice areas were 0.84 ± 0.16 and 0.86 ± 0.25 cm(2)/m(2) (p = 0.76). At follow-up (1.5 ± 1.3 years), echo data and survival did not differ (p = 0.17).
CONCLUSIONS: This multicenter study confirms the safety, efficacy, and ease of insertion of Perceval valves in elderly patients with small annulus. The performance of the smaller prosthesis was satisfying and prosthesis size did not affect patient outcome.
METHODS: The registries of 4 European centers, including 276 consecutive patients (mean age 79.7 ± 5.2 years, 69.9% females), were reviewed in order to compare data on the smallest model of the Sorin-Perceval sutureless prosthesis (Sorin Group, Saluggia, Italy) compared with larger models. The small valve ("S" size) was inserted (S group) in 47 patients, while 229 patients had a larger one (labeled "M" and "L" by manufacturer, herein L group). Except for body surface area (1.60 ± 0.16 vs 1.78 ± 0.19 m(2), p < 0.001), there were no other relevant preoperative differences. The European system for cardiac operative risk evaluation log was 11.4 ± 6.1 versus 12.6 ± 9.6 (p = 0.28).
RESULTS: Median sternotomy was the most frequent approach (S group 87.2% vs L group 79.5%, p = 0.31). The associated procedures were similar for both groups (31.9% vs 34.5%, p = 0.87). For isolated AVR, cardiopulmonary bypass and cross-clamp times were, respectively, 49.1 ± 16.0 and 30.7 ± 9.2 minutes (S group) versus 52.6 ± 23.1 and 32.3 ± 13.6 minutes (L group) (p = 0.33 and 0.45). Hospital mortality was nil (S group) versus 2.6% (L group) (p = 0.62). At discharge, the peak-pressure-gradients were 22.7 ± 7.9 and 20.9 ± 8.4 mm Hg (p = 0.24) while indexed effective orifice areas were 0.84 ± 0.16 and 0.86 ± 0.25 cm(2)/m(2) (p = 0.76). At follow-up (1.5 ± 1.3 years), echo data and survival did not differ (p = 0.17).
CONCLUSIONS: This multicenter study confirms the safety, efficacy, and ease of insertion of Perceval valves in elderly patients with small annulus. The performance of the smaller prosthesis was satisfying and prosthesis size did not affect patient outcome.
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