IVC Filters: Rate of Insertion, Indications, Effects on Prognosis, Evidence Basis for Current Practices. Paul D. Stein, MD

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Transcription:

IVC Filters: Rate of Insertion, Indications, Effects on Prognosis, Evidence Basis for Current Practices Paul D. Stein, MD Professor Department of Osteopathic Medical Specialties College of Osteopathic Medicine Michigan State University, East Lansing, Michigan

Open Procedures John Hunter Femoral vein ligation 1784 Bottini IVC ligation 1893 Homans Femoral vein ligation 1929 Fatal recurrent PE 5-8% Oschner, DeBakey IVC ligation 1943 Operative mortality 14% Recurrent PE 6% Fatal recurrent PE 2% Venous insufficiency 33% DeWeese, Hunter IVC suture plication 1958 Operative mortality 10% IVC occlusion 31% Moretz clip Adams/DeWesse clip Miles clip IVC clip 1959 1965 1971 Operative mortality 12% Recurrent PE 4% Fatal recurrent PE 1.7% IVC occlusion 33% Greenfield LJ. Arch Surg 1992;127:622-626. Jones TK et al. Ann Thorac Surg 1986;42:48-55

Permanent Filters Mobin Uddin umbrella Greenfield stainless steel filter Greenfield titanium filter 28F (9.3 mm) sheath 12F (4 mm) sheath 1969 Fatal recurrent PE <1% Occlusion 60% 1973 Occlusion 2% with or without anticoagulants Insertion site thrombosis 30%-41% 1989 Bird s Nest 1984 Venatech/LGM 1988 Simon Nitinol 1989 Greenfield LJ. Arch Surg 1992;127:622-626.

Mobin-Uddin Umbrella 1969

Greenfield Filter (1973)

Lazar J. Greenfield

Permanent Filters Vena Tech LGM

Retrievable Filters Recovery July 2003 Gunther Tulip Oct 2003 OptEase March 2004

Retrievable Filters Optease IVC Filter - Günther Tulip Celect IVC Filter From Cook Medical Filtre Veine Cave ALN

No. of VC Filters In Patients with PE 50,000 40,000 30,000 20,000 10,000 0 NHDS (1979-2010) Retrievable Approved 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Year Updated from: Stein et al. AJM; 2011;124:655-661

Indications for IVC Filter in PE Definite Contraindication to anticoagulation Recurrent PE despite anticoagulation Possible Severe PE in whom recurrence may be fatal PE with continuing DVT by ultrasound

Nationwide Inpatient Sample (NIS) Healthcare Cost and Utilization Project (HCUP) Agency for Healthcare Research and Quality (AHRQ) Samples approx 20% of US nonfederal, short-term hospitals About 1000 hospitals 5 to 8 million hospital stays HCUP Nationwide Inpatient Sample www.hcup-us.ahrq.gov/nisoverview.jsp

The Nationwide Inpatient Sample 1999-2008 2,110,320 PE Stein et al. AJM; 2012;125:478-484

In-hospital All-cause Mortality (%) 60 40 20 0 33.2 51.5 Unstable PE 1999-2008 VC Filter 7.6 17.6 No VC Filter 25.0 58.1 Anticoagulants* Thrombolytics** Embolectomy*** *Stein et al. AJC 2010:106:558-563 **Stein et al. AJM 2012;125:465-470 ***Stein & Matta. AJM 2012;125:471-477

Stable PE High Risk 1999 2008 Stein et al. AJM; 2012;125:478-484 Stein & Matta. AJM 2012;125:471-477

Stable PE Low Risk 1999-2008 10 In-hospital All-cause Mortality (%) 5 0 7.2 VC Filter 7.9 No VC Filter Stein et al. AJM; 2012;125:478-484

Low Risk Stable PE with DVT n= 721,230 1999-2008 10 In-hospital All-cause Mortality (%) 5 0 6.7 VC Filter 5.3 No VC Filter Stein et al. AJM; 2012;125:478-484

Unstable Patients PE attributable In-hospital Case Fatality Rate Stein et al. AJM; 2012;125:465-470

Embolectomy PE attributable In-hospital Case Fatality Rate Stein et al. AJM; 2012;125:471-477

Stable Low Risk No Thrombolytic Therapy & No Embolectomy PE attributable In-hospital Case Fatality Rate Stein & Matta (unpublished data)

2,110,320 PE (1999-2008) Stable No Lytics 95.3% Unstable 3.4% Stable and Lytics 1.3% Stein et al. AJM; 2012;125:478-484

Proportion That Received Filters Stein et al. AJM; 2012;125:478-484

Distribution of Vena Cava Filters n= 325,730 (1999-2008) Stable Low Risk 91.4% Unstable 6.0% Stable High Risk 2.6% Stein et al. AJM; 2012;125:478-484

Stable Patients With PE 50,000 Number of VC Filters Inserted 40,000 30,000 20,000 10,000 Retrievable Approved 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 Years Stein & Matta (Unpublished)

Unstable PE n= 72,240 No IVC Filter 73% IVC Filter 27% Stein et al. AJM; 2012;125:478-484

Retrievable Filter Complications (n=284) IVC or filter thrombosis 6.0% Filter migration, often asymptomatic 3.9% Filter tilt 7.7% Leg edema, moderate 0.7% Total 18.3% Stein et al Am J Cardiol 2004; 94:1090-1093

Embolized OptEase IVC Filter

Retrievable Filter Complications (n=144) IVC Thrombosis 2.1% New DVT 4.9% Filter Migration 1.3% Total 8.3% Janjua et al. J Invasive Cardiol 2010; 22:235-239

Half of retrievable IVC filter complications occurred after 3 months Janjua et al. J Invasive Cardiol 2010; 22:235-239

Retrievable IVC Filters n= 3,230 Attempted Retrival 41% Janjua et al. J Invasive Cardiol 2010; 22:235-239

Indications for Retrievable IVC Filter with PE Based on In-Hospital Case-Fatality Rate Data, Nationwide Inpatient Sample 1999-2008 (n=2,110,320 PE) Unstable patients (shock or on ventilatory support). Stable high-risk patients (administered thrombolytic therapy or embolectomy) Stein et al. AJM; 2012;125:478-484 Stein & Matta. AJM 2012;125:471-477

Pulmonary Embolism Routine IVC filter insertion in unstable patients or stable high-risk patients would save 1800 lives/year

Pulmonary Embolism Avoidance of unnecessary IVC filters in stable low-risk patients would save $133 million/year