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Invited Commentary| Volume 44, ISSUE 2, P193-194, August 2012

Discrepancies between Treatment Standards and Clinical Reality: The Role of Population-based Practice Registries – commentary on the first VASCUNET report

Open ArchivePublished:May 24, 2012DOI:https://doi.org/10.1016/j.ejvs.2012.05.005
      This issue of the Journal features a vitally important paper which, hopefully, heralds a new era of complementary reporting of vascular care. The VASCUNET Committee, a group of National vascular registry representatives supported by the European Society for Vascular Surgery (ESVS), presents its first peer-reviewed report on surgical practice pattern for peripheral arterial occlusive disease (PAOD) within nine countries across Europe and Australia.
      • Lees T.
      • Troëng T.
      • Thomson I.A.
      • Menyhei G.
      • Simo G.
      • Beiles B.
      • et al.
      International variations infrainguinal bypass surgery – a vascunet report.
      The sheer size of more than 32,000 analyzed peripheral bypass procedures warrants a powerful voice to its findings that cannot be ignored. Unlike previous population-based surveys,
      • Goodney Philip P.
      • Beck Adam W.
      • Nagle Jan
      • Welch H. Gilbert
      • Zwolak Robert M.
      National trends in lower extremity bypass surgery, endovascular interventions, and major amputations.
      the VASCUNET report presents stratified data on bypass level and choice of conduit according to PAOD severity. Thus it offers, at least theoretically, a unique opportunity to assess whether practice recommendations
      • Norgren L.
      • Hiatt W.R.
      • Dormandy J.A.
      • Nehler M.R.
      • Harris K.A.
      • Fowkes F.G.
      • for the TASC II Working Group
      Inter-society consensus for the management of peripheral arterial disease (TASC II).
      • Setacci C.
      • de Donato G.
      • Teraa M.
      • Moll F.L.
      • Ricco J.B.
      • Becker F.
      • et al.
      Chapter IV: treatment of critical limb ischaemia.
      are actually reflected in clinical reality.
      Why is such appraisal so important? Apart from external validation of guideline applicability and identification of conflicting evidence, population-based appraisal is essential to support credibility of surgical treatment options that are increasingly challenged by less invasive alternatives, such as in PAOD.
      • Setacci C.
      • de Donato G.
      • Teraa M.
      • Moll F.L.
      • Ricco J.B.
      • Becker F.
      • et al.
      Chapter IV: treatment of critical limb ischaemia.
      • Diehm N.
      • Baumgartner I.
      • Jaff M.
      • Do D.D.
      • Minar E.
      • Schmidli J.
      • et al.
      A call for uniform reporting standards in studies assessing endovascular treatment for chronic ischaemia of lower limb arteries.
      Thereby, the VASCUNET report highlights two crucial aspects. First, that it is feasible at all to collaborate across national boundaries to amalgamate individual registry data successfully. And second, how unexpectedly difficult it may turn out to extract clinically meaningful evidence from such meta-registries.
      Data completeness and validity (i.e., representativeness) represent the obvious challenges in any population-based research. The authors of the VASCUNET report have highlighted the variable limitations regarding data audit and validation process across the participating countries and share their concerns about uncertain data quality with us. Thus, interpretation of variations regarding both demographic patient profiles and practice pattern remains difficult due to potential confounding or bias.
      Far more astonishing, however, are the seeming difficulties to agree to the nature of baseline characteristics and outcome measures, even in the context of a prospective study design
      • Lees T.
      • Troëng T.
      • Thomson I.A.
      • Menyhei G.
      • Simo G.
      • Beiles B.
      • et al.
      International variations infrainguinal bypass surgery – a vascunet report.
      and accepted reporting standards.
      • Diehm N.
      • Baumgartner I.
      • Jaff M.
      • Do D.D.
      • Minar E.
      • Schmidli J.
      • et al.
      A call for uniform reporting standards in studies assessing endovascular treatment for chronic ischaemia of lower limb arteries.
      • Rutherford Robert B.
      • Dennis Baker J.
      • Ernst Calvin
      • Wayne Johnston K.
      • Porter John M.
      • Ahn Sam
      • et al.
      Recommended standards for reports dealing with lower extremity ischemia: revised version.
      Admittedly, the ‘art of the feasible’ mandates reduction to minimal datasets, in particular for registries with voluntary data capture. However, extractable information should still make sense clinically.
      It is interesting that almost none of the involved registries (many of which are run by the respective National vascular surgery societies) captured certain essential clinical information. For instance, how can it be explained that the VASCUNET countries performed roughly 10 times less bypass procedures per 100,000 population than the US in the same period?
      • Goodney Philip P.
      • Beck Adam W.
      • Nagle Jan
      • Welch H. Gilbert
      • Zwolak Robert M.
      National trends in lower extremity bypass surgery, endovascular interventions, and major amputations.
      In other words, what proportions were treated by valid alternatives such as supervised exercise or endovascular intervention,
      • Norgren L.
      • Hiatt W.R.
      • Dormandy J.A.
      • Nehler M.R.
      • Harris K.A.
      • Fowkes F.G.
      • for the TASC II Working Group
      Inter-society consensus for the management of peripheral arterial disease (TASC II).
      or were not treated at all? It seems unlikely that the endovascular shift should have been much more pronounced than in the US where almost 80% of PAOD patients were treated by endovascular means already in 2006. Or, what was the penetration of best medical treatment among this high risk population? This quality measure of overall vascular care is essential for surgical patients as much as for any other.
      • Norgren L.
      • Hiatt W.R.
      • Dormandy J.A.
      • Nehler M.R.
      • Harris K.A.
      • Fowkes F.G.
      • for the TASC II Working Group
      Inter-society consensus for the management of peripheral arterial disease (TASC II).
      And lastly, what was the clinical outcome of bypass surgery beyond 30 days?
      The lack of outcome information is particularly concerning when considering that some reported quality indicators did not comply at all with current practice guidelines.
      • Norgren L.
      • Hiatt W.R.
      • Dormandy J.A.
      • Nehler M.R.
      • Harris K.A.
      • Fowkes F.G.
      • for the TASC II Working Group
      Inter-society consensus for the management of peripheral arterial disease (TASC II).
      • Setacci C.
      • de Donato G.
      • Teraa M.
      • Moll F.L.
      • Ricco J.B.
      • Becker F.
      • et al.
      Chapter IV: treatment of critical limb ischaemia.
      Synthetic graft materials were overused to an incredible extent: up to 70% of claudicants received synthetic conduits, as did up to 50% of those with critical limb ischemia in some countries! Even for extreme indications such as below the knee bypass for ischemic tissue loss overall use of synthetic conduits reached 20%. Moreover, up to 40% of all surgical bypasses were applied to non-threatened, claudicating limbs, i.e. for relative indications. Perhaps as a consequence of the above, patency rates at 30 days remained significantly below the expected.
      More than anything else, these findings highlight the urgent need for conjoint efforts to improve monitoring and reporting of delivered treatment quality in clinical practice. Wherever national obligations are lacking, the vascular societies will have to assume the responsibility to implement, supervise and audit meaningful quality control and improvement programmes with mandatory reporting of minimal datasets. Supranational societies such as the ESVS are in an important position to recommend the most suitable datapoints in accordance with society reporting standards and to enforce uniform definitions in view of international audits. The VASCUNET initiative has just demonstrated how difficult such coordinations are. However, without comprehensive demonstration of reproducible treatment quality outside controlled studies, the credibility of our daily practice is at stake.

      References

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        International variations infrainguinal bypass surgery – a vascunet report.
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        National trends in lower extremity bypass surgery, endovascular interventions, and major amputations.
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        • de Donato G.
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        Chapter IV: treatment of critical limb ischaemia.
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        • Diehm N.
        • Baumgartner I.
        • Jaff M.
        • Do D.D.
        • Minar E.
        • Schmidli J.
        • et al.
        A call for uniform reporting standards in studies assessing endovascular treatment for chronic ischaemia of lower limb arteries.
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        • Rutherford Robert B.
        • Dennis Baker J.
        • Ernst Calvin
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        Recommended standards for reports dealing with lower extremity ischemia: revised version.
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