M Johnson Disclosures

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1 2/22/2013 IVC Filters: Current Controversies and the PRESERVE Study Matthew S Johnson MD FSIR Indiana University School of Medicine M Johnson Disclosures Speaking and Teaching Bayer Cook Nordion Research Support Nordion Consulting Boston Scientific CeloNova Endoshape Merit Nordion Penumbra Bruckheimer et al. JVIR 2003; 14: Complications of Permanent Filters Filter Bird s Nest 1 N FU (months) Recurrent PE DVT IVC Thrombosis % 6% 3.9% Titanium Greenfield % 22.7% 6.5% Vena Tech % 32% 11.2% Simon Nitinol % 8.9% 7.7% SS OTW Greenfield % 7.3% 1.7% TrapEase % 45.7% 2.8% Gunther Tulip % NR 9.6% Vena Tech LP % 10.3% 0% 1Meta-analysis from Streiff MB. Blood 2000; 95: Greenfield et al. J Vasc Surg 2000; 32: Rousseau et al. J Vasc Interv Radiol 2000; 11: Neuerburg et al. Cardiovasc Intervent Radiol 1997; 20: Kinney, TB. J Vasc Interv Radiol 2003; 14:

2 2/22/2013 Retrievable Vena Cava Filters: Rationale The rates of complications of vena cava filters are unknown but the risks are real Filter removal may reduce the risks of some of these complications, including caval thrombosis, filter migration, caval penetration, and DVT Retrievable IVC Filters: The Case Against The degree to which retrieval lessens the rates of complications of vena cava filters is unknown Filter modification may increase the rates of some complications, e.g., migration Filter removal introduces new risks Radiation and contrast exposure during retrieval; procedural complication; PE following removal of filter Millward. JVIR 2005; 16: Image courtesy of Shannon Kaufman, MD 2

3 2/22/2013 Lack of Data Lack of Consensus Paucity of randomized controlled trial data 1,2 Paucity of prospective trial data 3-5 Relative abundance of retrospective reviews 1. Decousus et al. NEJM 1998; 338: PREPIC Study Group. Circulation 2005; 112: Mismetti et al. Chest 2007; 131: Binkert et al. JVIR 2009; 20: Johnson et al. 2010; 21: Lack of Data Lack of Consensus Preponderance of data is limited in value Multiple disparate devices Retrospective >> Prospective Variable study methodologies Variable reporting of results Kaufman et al. JVIR 2009; 20: Lack of Data Concern for Utility Although their deployment seems of theoretical benefit, their clinical efficacy and adverse event profile is unclear. AUTHORS CONCLUSIONS: No recommendations can be drawn from the two studies There is a paucity of VCFs outcome evidence when used within currently approved indications and a lack of trials on retrievable filters. Young et al. Cochrane Database Syst Rev.2010 Feb 17;(2):CD

4 2/22/2013 Questionable Efficacy + Obvious Complications = Problem Images courtesy of John Kaufmann, MD FDA Action In response to a perceived increase in IVCFrelated complications* such as caval perforation filter fracture migration embolization paralleling the increased use of rivcf The FDA issued an initial communication on August 9, 2010, suggesting that rivcf should be removed when no longer needed *MAUDE database = Manufacturer And User facility Device Experience IVC Filters: Initial Communication: Risk of Adverse Events With Long-Term Use [Posted 08/09/2010] AUDIENCE: Emergency Medicine, Surgery ISSUE: Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of pulmonary embolism (PE) has subsided. The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation. BACKGROUND: FDA reviewed the literature and is conducting quantitative decision analysis modeling to evaluate the change in the risk/benefit profile after retrievable IVC filter implantation over time. More information about FDA s decision analysis model including risk/benefit implantation timeframe suggestions will be made available in an update to this communication as well as in a future publication in a peer-reviewed medical journal. RECOMMENDATION: FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from PE is no longer needed. FDA encourages all physicians involved in the treatment and follow-up of IVC filter recipients to consider the risks and benefits of filter removal for each patient. If a patient has a retrievable IVC filter that should be removed based on his or her individual risk/benefit profile, the primary care physician and/or those providing ongoing patient care should refer the patient for IVC filter removal when feasible and clinically indicated. 4

5 2/22/2013 Societal Response Discussions between members of the Society of Interventional Radiology (SIR), The Society for Vascular Surgery (SVS), and The FDA began in November, 2010, and Defined questions (see next slide), and Considered the best method to answer questions RCT versus other, considering Scope Participants Logistics (including funding) FDA s Questions Include: What are the types and rates of adverse events (AE) associated with permanent and retrievable filters? Are there device designs or materials that are more prone to those AE? What are the most common AE associated with off label use? What is the rate of prophylactic (vs. on-label) IVCF placement? What is the proportion of permanent to retrievable filters being implanted? Options RCT is inadequate to address complicated landscape (see next slide) Registries, e.g., the MAUDE database, have no denominator Need a prospective study with definitions Subject population (demographics- Who? Why?) Device(s) Goals (e.g., prophylaxis vs standard indication) Terms (e.g., DVT, migration, perforation) Methodology (e.g., imaging at X timepoint) Outcomes (e.g., freedom from complication) 5

6 2/22/2013 The Filters Which Have Been Cleared by the FDA ALN Argon (Rex) B Braun Bard BSC Cook Cordis Rafael MT Volcano (Crux) ALN Option VenaTech LGM, VenaTech LP SN, Recovery Meridian Greenfield(s) Birds Nest, Tulip, Celect TrapEase, OptEase SafeFlo Crux Options RCT is inadequate to address complicated landscape Registries, e.g., the MAUDE database, have no denominator Need a prospective study with definitions Subject population (demographics- Who? Why?) Device(s) Goals (e.g., prophylaxis vs standard indication) Terms (e.g., DVT, migration, perforation) Methodology (e.g., imaging at X timepoint) Outcomes (e.g., freedom from complication) Prospective Study = PRESERVE The aforementioned discussions- SIR, SVS, FDA, other societal representatives, AND, over the last year, manufacturers of IVCF cleared for use in the UShave led to the development of a soon-to-be initiated national study (PRESERVE) directed toward the evaluation of the safety and effectiveness of IVCF, and to answering the FDA s other questions as well That study was presented to the FDA on August 10,

7 2/22/2013 The PRESERVE Study PREdicting the Safety and Effectiveness of inferior VEna cava filters The PRESERVE Investigators Methods (Current Draft) Prospective, multicenter, single-arm clinical trial of adults ( 18 years of age) in whom IVCF are clinically indicated Primary endpoints Safety = freedom from major complications Effectiveness = freedom from PE subjects will be enrolled, with a minimum of ~300 subjects per filter type Methods (Current Draft) Subjects whose filters are removed will be evaluated 3 months following removal 7

8 2/22/2013 Methods (Current Draft) In addition to study-mandated images, the following will be sent to the core lab, if obtained LE US or CT venogram in cases of suspected DVT CT arteriograms or pulmonary arteriograms in cases of suspected PE Case report forms will be provided to CRO, as will (hopefully) standard reports PRESERVE: Recent Updates A joint SIR/SVS entity, called the IVC Filter Study Group Foundation has been created That entity has chosen the CRO that will run the study Summary As a multidisciplinary (SIR, SVS et al) initiative conceived and created in association with the FDA and industry, the PRESERVE trial represents a paradigmatic shift, in which each group has agreed to work together to address an important healthcare concern. The PRESERVE trial also represents a shift toward recognition that demonstration of safety and efficacy may not necessarily require a randomized controlled trial. 8

9 2/18/2013 VuMedi Webinar IVC Filters My Approach to Filter Removal - Patient Evaluation, Anticoagulation Thomas B. Kinney, MD, MSME UCSD Medical Center Professor of Clinical Radiology Director UCSD HHT Clinic tbkinney@ucsd.edu Disclosures Chairman, Data Safety Monitoring Board, Crux Biomedical Member, Clinical Events Committee, Bio2 Medical, Inc Outline Strategy FDA Follow-up Management of IVC filter patient Selection from removal Anticoagulation management during removal 1

10 2/18/2013 Pre-filter removal strategy *Kaufman JA, Kinney TB, Streiff MB, et al. J Vasc Interv Radiol 2006;17: Patient Clinician Education: -Permanent versus optional filters Review pertinent imaging planning for ease of removal Placement issues Enroll in clinical follow-up Recurrent PE after removal August 9, 2010 Removing Retrievable Inferior Vena Cava Filters: Initial Communication. FDA Communication dated August 9, : 259,000 insertions? Removing Retrievable Inferior Vena Cava Filters: Initial Communication. FDA Communication dated August 9,

11 2/18/2013 FDA Recommendation implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from PE is no longer needed. Removing Retrievable Inferior Vena Cava Filters: Initial Communication. FDA Communication dated August 9, Tracking Method(s) Software Filter clinic Responsible Individual Third Party Management of patients with IVC filters* *Kaufman JA, Kinney TB, Streifff MB, Sing RF, Proctor MC, Beaker D, Cipolle M, Comerota AJ, Millward SF, Rogers FB, Sacks D, Venbrux AC. Guidelines for the use of retrievable and convertible vena cava filters: Report from the Society of Interventional Radiology Multidisciplinary Consensus Conference. J Vasc Interv Radiol 2006; 17:

12 2/18/2013 Patient selection for filter discontinuation Patient evaluation before filter D/C IVC filters can be removed safely with fully anticoagulated pts* Jugular punctures (except Optease) performed with u/s guidance *Hoppe H, Kaufman JA, Barton RE, et al. Safety of Inferior Vena Cava Filter Retrieval in Anticoagulated Patients. Chest 2007; 132:

13 2/18/2013 Conclusions Observe indications for insertion Educate your physicians and patients Put in place systems to track patients Filters can be removed frequently when no longer indicated Pts can have filters removed on full anticoagulation 5

14 2/22/2013 Retrieval Techniques that work - Most of the Time Marcelo Guimaraes, M.D. Associate Professor Radiology and Surgery Division of Vascular and Interventional Radiology Medical University of South Carolina Cook Medical - Patents holder - Consultant Disclosure Terumo Interventional Systems - Consultant, researcher Bayer Medical - Consultant Baylis Medical - Consultant US guided Jugular access IVC Filter evaluation. Any clots in the IVC? Venocavography CO2 1

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16 2/22/2013 IVC thrombosis Consider pharmacological/mechanical thrombectomy, stenting 3

17 2/22/2013 In doubts about clots in the IVC? IVC / Iliac veins IVUS Venous Doppler US did not rule out clots in the common/external iliac veins? Consider Bilateral Iliac venogram 4

18 2/22/2013 Be thorough! Venous Doppler US report: No DVT in the LE Devices for IVC filter removal Basic material for removal: - 5 / 6 Fr Multipurpose/vertebral 10 mm snare 10-Fr Introducer sheath 5-Fr catheter - Snare (10, mm) - 10-Fr Long vascular sheath Devices for IVC filter removal - Removal kit (cone or snare) - GooseNeck Snare / Ensnare - Alligator forceps 5

19 2/22/2013 Temporary Filter removal 84 days after implant IVC filter removal: cone 6

20 2/22/2013 IVC filter removal: cone 7

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22 2/22/2013 IVC filter removal: cone Technical detail Technical details Check RAO or LAO once you believe you re aligned One view is no view 9

23 2/22/2013 Misalignment of the IVC filter hook and the retrievable system? Filter removal: alligator forceps 10

24 2/22/2013 Filter removal: PTA balloon / snare 11

25 2/22/2013 Filter removal:alligator forceps/snare 12

26 2/22/2013 Filter removal: creation of a loop? 13

27 2/22/2013 Optease: just advance the sheath don t advance the filter together Creatinine

28 2/22/2013 What should be avoided What should be avoided Too much tension pulling the snare/cone backwards - gentle manipulation Listen to the patient. Pain? What should be avoided Back pain 15

29 2/22/2013 Histology after filter removal Subendothelial hemorrhage J Vasc Interv Radiol Nov;16(11): Brountzos E, et al. JVIR Volume 14(6), June 2003, pp Hamada, A, et al. J Vasc Interv Radiol Nov;16(11): Sometimes there s nothing better than surgery IVC filter deployed in the R renal vein What to do in case of unsuccessful retrieval? Studies: higher incidence of IVC thrombosis with IVC filter Encourage exercise Patient s surveillance / education about the IVC filter 16

30 2/22/2013 What to do in case of unsuccessful retrieval? Consider anticoagulation therapy if filter can not be removed (contra-indicated/technical limitation) Return in case of minimal discomfort in the LE (heaviness, swelling) What to do in case of unsuccessful retrieval? Consider advanced techniques 17

31 Advanced Retrieval Techniques John A. Kaufman MD, MS Dotter Interventional Institute Portland, OR Disclosures John Kaufman, MD Company/Organization NIH, Gore, Guerbet Bio2, EV3, Guerbet, Cook, Gore Delcath, VuMedi, VIVA Hatch, Veniti Affiliation/Relationship Research Consulting Medical Board Ownership interest Principles of Complex Retrieval Assess need for removal Pre-procedure imaging - CT Review of prior attempts Anticoagulate during procedure Sequential increase in aggressiveness General anesthesia 1

32 Penetration Penetration 2

33 Penetration Penetration 63 yr female for filter retrieval 3

34 1 Month Later - New R Flank Pain Endobronchial Forceps Stavropoulos et al. JVIR 2008;19:

35 R Flank Pain Persists What do you do? What do you tell The patient? The company? The FDA? Her lawyer? Filter in Place 4 Months 5

36 Spectranetics Laser CVX-300 system 308 nm Excimer laser Ultraviolet 50 micron penetration 12F, 14F, 16F 50 cm length Kuo W et al, JVIR 2011;22: Laser Removal Activation < 2 Seconds 6

37 Prior DVT and PE For major surgery Filter placed for short-term protection History 5 Months Later Failed Retrieval Could not engage hook Clinic Visit Tolerating anticoagulation No symptoms from filter But patient told filter must come out! What is the right thing to do? 7

38 Right or Wrong - Retrieval Pulled Really Hard Lots of Problems. 8

39 Lots of Problems. Bi-Directional Approach Biopsy forceps Two snares Four Sheaths 16 F jugular 18 F femoral 14 F femoral 10 F femoral Equipment So Far 9

40 Try From Above Again Final Cavogram Failed Retrieval 10

41 Open Removal Conclusions Assess real need for retrieval Planning is essential Always have a back-up strategy Be prepared to stop early 11