I am NOT: Wishful Thinking Against New Ideas Against New - PowerPoint PPT Presentation

4/14/2016 Disclosures Inferior Vena Cava Filters: A Love /Hate (Mostly Hate) Relationship Lack of Political Correctness Gregory L. Moneta, M.D. Professor and Chief, Vascular Surgery Oregon Health & Science University Knight Cardiovascular Institute Portland. Oregon, USA The Problem of the “Con-Position” Non Thinking ! Mistaken thinking I am NOT: Wishful Thinking • Against New Ideas • Against New Therapies “Lemming” Behavior • Against Endovascular Therapies Misuse of the Bully Pulpit 1

4/14/2016 Why Filters: PE Happens IVC Filters and Bariatric Surgery • Bariatric Outcomes Longitudinal Database • 73,921 subjects • About 200,000 • Mandated clinical pathways to prevent VTE deaths/year secondary to PE • Risk VTE in 90 days: 0.42% • 626 patients with IVC filters Many are perhaps -increased risk of VTE with IVC filter preventable -hazard ratio 7.66, 95% CI 4.55-12.91 Winegar, et al. Surg Obes Relat Dis 20111: 7;181-188 Trauma Prophylaxis Filters for Prophylaxis • Eastern Association for Surgery for Trauma (EAST): -High risk injuries precluding thromboprophylactic Rx -Level 3 recommendation • American College Chest Physicians (ACCP) -”We do not recommend the use of an IVC filter as • Michigan Trauma Registry* thromboprophylaxis, even in patients at high risk for -803 prophylactic IVC filters in 39,456 patients (2%) VTE. -Hospital variation (0.6 TO 9.6%) in filter use. -No variation in mortality by quartile use of filters. -Increased DVT with prophylactic filter (OR 1.83; 95% CI 1.15 – 2.93) *Ann Surg 2015; 262: 577-85) 2

4/14/2016 Complications Vena Cava Filters IVC Filters (Increasing Utilization) • Misplacement • Thrombosis • Migration • 1979: 2000 filters • Fracture • By 1990: >120,000 • Penetration Greenfield filters had been placed • Ineffective • 2000: 50,000/yr -mortality • 2009:>130,000/yr -PE prevention • Inducing VTE Misplaced filter secondary to Renal Vein Variant Right Hepatic Vein Filter 3

4/14/2016 Deployment Errors Thrombosis: IVC Filter / Vena Cava/ Iliac Veins Intracardiac Filter: Premature unsheathing led to ensnarement in the right atrium IVC Filters IVC Filters (FDA Warning: Posted August 9, 2010) •29 year old male with a • Since 2005 there were 921 adverse event perforated duodenum from an reports: IVC filter. -328 migrations •4 unit drop in Hematocrit -146 embolizations of device components • Infected, disrupted infrarenal -70 IVC perforations aorta discovered at exploration. -56 filter fractures •Treated with rifampin soaked Dacron aortic interposition graft 4

4/14/2016 IVC Filters (Mobin Uddin Filter) • First IVC filter • Developed in late 1960s • Initial favorable reports • Late reports: -50% IVC occlusion rate -High rate of PE -Migration IVC Filters IVC Filters (Kimray-Greenfield Filter*) (Kimray-Greenfield Filter: 1988 report*) • 469 patients • Introduced in 1973 • 146 long-term follow-up (mean 43 months) • 1981 report: • 190 lost to follow-up -156 patients • 133 died (33%) -119 patients followed • 4% PE rate (17 fatal, 9 nonfatal) -3% PE rate • 4% IVC occlusion -5% IVC occlusion • 44% with post thrombotic syndrome - No migration *Arch Surg 1981; 116: 1451-1456 *Surgery 1988; 104: 706-712 5

4/14/2016 IVC Filters IVC Filters (Kimray-Greenfield Filter: 1988 report*) (Literature) • More than 600 reports • Served as evidence for efficacy of IVC filters • Likely would not be sufficient evidence by • Virtually all retrospective analysis of single modern standards: institution case-series -Half the patients lost by either death or LTFU -No control group • Only ONE randomized, controlled trial -No follow-up imaging *Surgery 1988; 104: 706-712 IVC Filters IVC Filters (PREPIC Study: Prevention du Risque (PREPIC Study) d’Pulmonarie par Interruption Cave ) • Published in 1988 • One of two types of anticoagulation • 400 consecutive patients with acute • With or without addition of a vena cava filter proximal DVT with or without PE • Considered ‘high-risk” by their physicians 6

4/14/2016 IVC Filters IVC Filters (PREPIC Study: Two-year Results) (PREPIC Study: Eight-year Results) • in symptomatic PE in the filter group • No mortality difference with or without filter -6.2% vs. 15.2% (p =0.008) • Filter patients: 10% higher DVT rate (95% • in DVT in the filter group CI, 11.6% to 20.8%) -35.7% vs. 27.5% (p= 0.04) • Nonstatistically significant reduction in PE, • No difference in mortality p=0.16 • IVC Filters IVC Filters (PREPIC Study: How was PE determined?) (PREPIC Study: What Has Happened) • Annual phone calls: -Questioned for symptoms suggestive of VTE • Weak findings of the PREPIC study and no other randomized trials has permitted great variation in the -Imaging recommended based on answers use of filters. - Guidelines • Therefore not just symptoms drove patients to - ”Judgment” hospital - Financial motivation - Industry • Is discovering a condition evident only on probing a valid patient-centered outcome? • 7

4/14/2016 PREPIC2 Study* IVC Filters • Randomized trial of retrievable IVC filters with (Guidelines) anticoagulation vs anticoagulation alone. • Acute symptomatic PE with leg DVT and RV • American college of Chest Physicians dysfunction and/or pulmonary hypertension • American Heart Association • Filter + AC group, n=200 • British Committee for Standards in Hematology • AC only, N=199 • Thrombosis Interest Group of Canada • 193 filters with 153/164 retrievals • Filter + AC group: Recurrent PE in 6 (3%, all Only consensus is placement in patients with VTE and a contraindication to fatal) anticoagulation! • AC only: Recurrent PE in 3 (1.5%, 2 fatal) *JAMA 2015; 313:1627-635 IVC Filters IVC Filters (Guidelines: No Consensus) (How Did We Get Where we Are?) • VTE despite anticoagulation • Benefits: Difficult to prove • Patients with recent VTE who must have • Complications: Are now obvious: anticoagulation held for surgery -Bird’s Nest: 0.34% procedural deaths • Patients with proximal DVT and poor -VenaTech: 22% IVC occlusion at 5 years cardiac reserve 33% IVC occlusion at 9 years • Patients with free-floating DVT -Bard Retrievable: 16% risk stent fracture • Primary prevention in high-risk patients -Overall 19% cava vena penetration rate* *Circulation 2015; 132:944-952 8

4/14/2016 IVC Filters IVC Filters (How Did We Get Where we Are?) (How Did We Get Where we Are?) • 510 (k) process in 1976 served as the basis of • U.S. Food and Drug Administration (FDA) approval approval of the Mobin Uddin filter process for vena cava filters: -there was no previous approved filter! - all filters approved through the 510 (k) process for • 510 (k) process in 1985 served as the basis of devices approval of the Greenfield filter - NOT based on safety -based on approval of the Mobin Uddin filter! - NOT based on efficacy 510 (k) process: Titanium Greenfield, Bird’s Nest, VenaTech, Gunther Tulip, etc - Based on similarity to an existing product • IOM recommends 510 (k) process be stopped! IVC Filters Questions? Conclusions: Why I dislike IVC Filters • It is unclear why IVC filters were ever approved. • There is no consensus on the use of IVC filters. • There is no proof IVC filters save lives or are even remotely cost effective. • There is clear evidence IVC filters can cause harm. Columbia River, Oregon 9

4/14/2016 IVC Filters (FDA MedWatch Safety information and Adverse Event Reporting Program) • On line: www.fda.gov/MedWatch/report.htm • Phone: 1-800-332-1088 to request form • Fax: 1-800-FDA-0178 10