Inferior Vena Cava Filter Registry

Database updatesAugust 2009Inferior VenaCava FilterRegistry

August 2009Contents• The growth of the database• The potential for further growth• Country of placement• Age and gender profiles• Indication• Prophylaxis in high risk patients• Intention• Device• Location• Insertion complications• Filter complications• Retrieval / conversiondocument assembled 22/09/2009

Database reportInferior Vena Cava Filter RegistryThe growth of the databaseThe charts below show the growth of the database in terms of both contributors and numbers of procedures.The growth of the database (n=147 users; n=680 treatments)Cumulative number of placements Cumulative number of usersCumulative number ofplacements600500400300200100180150120906030Cumulative number ofregistered users0Apr 2008May 2008Jun 2008Jul 2008Aug 2008Sep 2008Oct 2008Nov 2008Dec 2008Jan 2009Feb 2009Mar 2009Apr 2009May 2009Jun 2009Jul 2009Aug 2009Period0document assembled 29/09/2009powered by Dendrite

August 2009The potential for further growthCountry of the registered users (n=147 registered users)UnspecifiedNon-UKCountryNothern IrelandWalesScotlandEngland0 20 40 60 80 100 120Number of usersdocument assembled 29/09/2009

Database reportInferior Vena Cava Filter RegistryCountry of placementCountry of placement (n=680 placements)EnglandN. IrelandCountryScotlandWalesUnknown0 50 100 150 200 250 300 350 400 450 500Number of placementsdocument assembled 29/09/2009powered by Dendrite

August 2009Age and gender profilesGenderAge at procedure / yearsFemale Male Unspecified All99 0 1 0 1Unspecified 3 0 0 3All 383 297 0 680Age and gender (n=677 placements)30%Female MalePercentage of patients25%20%15%10%5%0%99Age at proceduredocument assembled 29/09/2009

Database reportInferior Vena Cava Filter RegistryIndicationThe great majority of filters are being placed for accepted indications according to Society of InterventionalRadiology criteria.DataIndicationCountPercentagePE despite anti-coagulation 82 19.3%PE plus contra-indication to anti-coagulation 170 40.0%DVT / PE plus limited cardio-pulmonary reserve 31 7.3%DVT with high risk of embolisation 92 21.6%Paradoxical emboli Indication 3 0.7%DVT with contra-indication to anti-coagulation 131 30.8%Adjunct to lysis 10 2.4%Prophylaxis in high risk patient 118 27.8%Pre-operative with acute DVT / PE 208 48.9%Pregnant with DVT / PE 18 4.2%Other 51 12.0%Unspecified 26Patient denominator 680Indication (n=654 placements)Pre-operative with acute DVT / PEPE plus contra-indication to anti-coagulationDVT with contra-indication to anti-coagulationProphylaxis in high risk patientIndicationDVT with high risk of embolisationPE despite anti-coagulationOtherDVT / PE plus limited cardio-pulmonary reservePregnant with DVT / PEAdjunct to lysisParadoxical emboli Indication0% 10% 20% 30% 40% 50%document assembled 29/09/2009Percentage of patientspowered by Dendrite

August 2009Prophylaxis in high-risk patientsDataHigh risk groupsCountPercentageHead / spinal injury / paraplegia / prolonged immobility 14 12.7%Major trauma 9 8.2%Bariatric surgery 3 2.7%Hypercoagulable state 12 10.9%Malignancy 54 49.1%Pre-operative with no acute DVT/PE 53 48.2%Unspecified 8Patient denominator 118High risk groups (n=110 placements)Bariatric surgeryMajor traumaHigh-risk groupsHypercoagulable stateHead / spinal injury / paraplegia / prolongedimmobilityPre-operative withno acute DVT/PEMalignancydocument assembled 29/09/20090% 10% 20% 30% 40% 50%Percentage of patients

Database reportInferior Vena Cava Filter RegistryIntentionWhere the intention has been stated, retrieval is planned in the majority of cases. Most published series suggestthat retrieval is actually carried out in only a minority. Is there a mismatch between intention and practice?Time will tell.DataIntentionCountPercentagePermanent 272 41.4%Temporary 306 46.6%Conversion 4 0.6%Undecided 75 11.4%Unspecified 23All 680Percentage of placements50%45%40%35%30%25%20%15%10%5%0%Intention (n=657 placements)Permanent Temporary Conversion UndecidedIntentiondocument assembled 29/09/2009powered by Dendrite

August 2009DeviceOne of the purposes of the registry is to compare devices in terms of complications and retrievability. Substantialnumbers will be required for comparisons to be statistically meaningful.DataDeviceCountPercentageB Braun Tempofilter IVC filter (retrievable) 1 0.2%B Braun VenaTech LGM IVC filter 1 0.2%Bard G2 IVC filter 22 3.4%Bard Recovery IVC filter (retrievable) 30 4.6%Cook Birds Nest IVC filter 3 0.5%Cook Celect IVC filter (retrievable) 134 20.5%Cook Gunther Tulip IVC filter (retrievable) 244 37.3%Cordis OptEase IVC filter (retrievable) 104 15.9%Cordis TrapEase IVC filter 59 9.0%Pyramed ALN IVC filter (retrievable) 78 6.9%Simon Nitinol IVC filter 11 1.7%Unspecified 26All 680Make and type of device (n=654 placements)Cook Gunther Tulip IVC filter (retrievable)Cook Celect IVC filter (retrievable)Make and type of deviceCordis OptEase IVC filter (retrievable)Cordis TrapEase IVC filterPyramed ALN IVC filter (retrievable)Bard Recovery IVC filter (retrievable)Bard G2 IVC filterSimon Nitinol IVC filterCook Birds Nest IVC filterB Braun Tempofilter IVC filter (retrievable)0% 10% 20% 30% 40%document assembled 29/09/2009Percentage of placements

Database reportInferior Vena Cava Filter RegistryLocationThe great majority of placements are described as infrarenal and very few as juxtarenal. Many operators aim todeploy the apex of the filter at about the level of the renal veins. The original intention was that this locationwould be classified as juxtarenal. It may be that some operators are placing filters in this location, but describingit as infrarenal.DataLocationCountPercentageInfra-renal IVC 590 90.8%Juxta-renal IVC 31 4.8%Supra-renal IVC 26 4.0%Other 3 0.5%Unspecified 30All 680Percentage of placements100%90%80%70%60%50%40%30%20%10%0%Location (n=650 placements)Infra-renal IVC Juxta-renal IVC Supra-renal IVC OtherLocationdocument assembled 29/09/2009powered by Dendrite

August 2009Insertion complicationsThe insertion complications are very few. This is predictable and reassuring.DataInsertion complicationsCountPercentageNone 406 98.5%Access site vein thrombosis 0 0.0%Haematoma 1 0.2%Embolisation 0 0.0%Sepsis 1 0.2%Other 4 1.0%Unspecified 268All 680Insertion complications (n=412 placements)NoneSepsisInsertion complicationAccess sitethrombosisHaematomaEmbolisationOther0% 20% 40% 60% 80% 100%Percentage of placementsdocument assembled 29/09/2009

Database reportInferior Vena Cava Filter RegistryFilter complicationsVery few follow up reports have been received to date. The registry aims to collect follow-up data at one yearafter insertion. Therefore the paucity of relevant data at Q5 is not surprising. The success of this registry is verydependent on follow-up data. Contributors will need to be reminded and encouraged to submit this data.DataFilter complicationsCountPercentageNone 16 55.2%Migration >10 mm 2 6.9%Caval wall perforation 7 24.1%Structural filaure 0 0.0%Other 6 20.7%Unspecified 651All 680Filter complications (n=29 placements)NoneFilter complicationMigration >10 mmCaval wall perforationStructural failureOther0% 10% 20% 30% 40% 50% 60%Percentage of placementsdocument assembled 29/09/2009powered by Dendrite

August 2009Retrieval / conversionIt appears that retrieval has been attempted so far in about half the cases for whom temporary placement wasintended. In due course, valuable information will be available on the proportion that are not retrieved andthe reasons for non-retrieval.Retrieval conversion attemptedCountryNo Yes Unspecified AllEngland 57 103 330 490Wales 3 2 14 19Scotland 5 19 21 45N. Ireland 14 29 27 70Unspecified 5 11 40 56All 84 164 432 680document assembled 29/09/2009

Dendrite Clinical SystemsDr Peter K.H. WaltonManaging Director59A Bell StreetHenley-on-ThamesOxfordshire RG9 2BAUnited KingdomPhone +44 (0) 1491 411 288Fax +44 (0) 1491 411 377email peter.walton@e-dendrite.comwww.e-dendrite.com