A multicenter, phase I evaluation of cryopreserved venous valve allografts for the treatment of chronic deep venous insufficiency

Michael Dalsing, S. Raju, T. W. Wakefield, S. Taheri

Research output: Contribution to journalArticle

36 Citations (Scopus)

Abstract

Purpose: A phase I feasibility study was conducted to determine whether cryopreserved venous valved segments would remain patent/competent in a short-term period (6 months). Methods: The target group consisted of 10 patients (C4-6, E, A(D), P(R)). The exclusion criteria included untreated superficial/perforator venous disease, significant venous or arterial obstruction, hypercoagulability or coagulopathy, and significant preexisting medical conditions. Required preoperative tests were venous duplex, ascending/descending venography, and a physiologic study (eg, APG, blood typing, an ankle/brachial index, and if post-thrombotic, a hypercoagulability work-up). A single-valve transplant was placed below all reflux, aided by anticoagulation with or without a distal arteriovenous fistula. Postoperative assessment included duplex scanning/clinical examination (at 1, 3, and 6 months), descending venogram (at 1 month), and physiologic study (at 1 and 6 months). The primary end point was valve patency/competence, with clinical outcome as a secondary end point. Adverse events were recorded. Results: After eliminating protocol violations, nine patients with superficial femoral (5) or popliteal (4) vein valve transplants were studied. Six-month actuarial results show a patency rate of 67% ± 16% and 78% ± 13%, respectively, a primary and secondary competency rate of 56% ± 17% and 67% ± 16%, respectively, and a 100% patient survival rate. Clinical outcome averaged 1.1, with healing and/or freedom from ulcer recurrence, in six of nine patients. A postoperative risk of seroma formation (3) and cellulitis (1) exists. Conclusion: In patients with few remaining therapeutic options, one can achieve a 6-month assisted patency and competency rate of 78% and 67%, respectively, with an improved clinical outcome.

Original languageEnglish
Pages (from-to)854-866
Number of pages13
JournalJournal of Vascular Surgery
Volume30
Issue number5
DOIs
StatePublished - 1999

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Venous Valves
Venous Insufficiency
Allografts
Thrombophilia
Popliteal Vein
Blood Grouping and Crossmatching
Transplants
Therapeutics
Seroma
Ankle Brachial Index
Preexisting Condition Coverage
Clinical Competence
Cellulitis
Phlebography
Arteriovenous Fistula
Feasibility Studies
Thigh
Ulcer
Survival Rate
Recurrence

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery

Cite this

A multicenter, phase I evaluation of cryopreserved venous valve allografts for the treatment of chronic deep venous insufficiency. / Dalsing, Michael; Raju, S.; Wakefield, T. W.; Taheri, S.

In: Journal of Vascular Surgery, Vol. 30, No. 5, 1999, p. 854-866.

Research output: Contribution to journalArticle

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