PURPOSE: The purpose of this study was to evaluate whether intensive surveillance compared with routine follow-up examinations improves femoropopliteal/crural graft patency. METHODS: After operation the patients were randomized to intensive (n = 79) or routine surveillance (n = 77). The groups were matched with regard to sex, diabetes, indication for surgical procedure, surgical procedure, and graft material. Intensive surveillance was clinical examination, ankle/brachial index measurements, and duplex scans 1, 3, 6, 9, 12, 15, 18, 21, 24, and 36 months after operation. Routine surveillance was clinical examination and ankle/brachial index measurements without duplex scanning 1, 12, 24, and 36 months after operation. Grafts with a decrease in ankle/brachial index of more than 0.15 compared with the initial postoperative ankle/brachial index or a duplex scan showing a graft or anastomotic stenosis of more than 50% underwent angiography and if necessary, a revision or repeat procedure. Occluded grafts were reopened with thrombectomy or thrombolysis or were replaced with a new graft. RESULTS: Assisted primary cumulative vein graft patency in the intensive group (n = 56) compared with that in the routine surveillance group (n = 50) after 3 years was 78% versus 53% (chi square analysis, 4.51; one degree of freedom; p < 0.05). Secondary patency was 82% versus 56% (chi square analysis, 5.62; one degree of freedom; p < 0.05). Assisted primary cumulative e-polytetrafluoroethylene and composite graft patency after 1 year in the intensive group (n = 23) compared with that of the routine surveillance group (n = 20) was 57% vs 50% (chi square analysis, 2.17; one degree of freedom; p > 0.1). Secondary patency was 67% vs 54% (chi square analysis, 1.85; one degree of freedom; p > 0.1). Revisions were made on 14 patent and 10 thrombosed grafts in the intensive group and on four patent and 15 thrombosed grafts in the routine surveillance group. All except eight were made during the first postoperative year. CONCLUSIONS: Intensive surveillance identified failing vein grafts leading to a significantly higher cumulative assisted primary and secondary patency compared with cumulative assisted primary and secondary patency after routine follow-up examination. The patency of e-polytetrafluoroethylene and composite grafts was not influenced by intensive surveillance.
RCT Entities:
PURPOSE: The purpose of this study was to evaluate whether intensive surveillance compared with routine follow-up examinations improves femoropopliteal/crural graft patency. METHODS: After operation the patients were randomized to intensive (n = 79) or routine surveillance (n = 77). The groups were matched with regard to sex, diabetes, indication for surgical procedure, surgical procedure, and graft material. Intensive surveillance was clinical examination, ankle/brachial index measurements, and duplex scans 1, 3, 6, 9, 12, 15, 18, 21, 24, and 36 months after operation. Routine surveillance was clinical examination and ankle/brachial index measurements without duplex scanning 1, 12, 24, and 36 months after operation. Grafts with a decrease in ankle/brachial index of more than 0.15 compared with the initial postoperative ankle/brachial index or a duplex scan showing a graft or anastomotic stenosis of more than 50% underwent angiography and if necessary, a revision or repeat procedure. Occluded grafts were reopened with thrombectomy or thrombolysis or were replaced with a new graft. RESULTS: Assisted primary cumulative vein graft patency in the intensive group (n = 56) compared with that in the routine surveillance group (n = 50) after 3 years was 78% versus 53% (chi square analysis, 4.51; one degree of freedom; p < 0.05). Secondary patency was 82% versus 56% (chi square analysis, 5.62; one degree of freedom; p < 0.05). Assisted primary cumulative e-polytetrafluoroethylene and composite graft patency after 1 year in the intensive group (n = 23) compared with that of the routine surveillance group (n = 20) was 57% vs 50% (chi square analysis, 2.17; one degree of freedom; p > 0.1). Secondary patency was 67% vs 54% (chi square analysis, 1.85; one degree of freedom; p > 0.1). Revisions were made on 14 patent and 10 thrombosed grafts in the intensive group and on four patent and 15 thrombosed grafts in the routine surveillance group. All except eight were made during the first postoperative year. CONCLUSIONS: Intensive surveillance identified failing vein grafts leading to a significantly higher cumulative assisted primary and secondary patency compared with cumulative assisted primary and secondary patency after routine follow-up examination. The patency of e-polytetrafluoroethylene and composite grafts was not influenced by intensive surveillance.
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