This case involves a 39-year-old severely obese man who presented to the hospital with severe right flank pain. Upon admission, the patient had a CT scan which showed a hematoma on the right side. The hospital staff elected to not put him on anti-coagulants for prophylaxis; due to a possible ongoing bleed even though the patient was bed ridden and not improving. One week into his hospital stay, the patient experienced severe shortness of breath and leg swelling. The only treatment he received was Albuterol. The patient was not given compression stockings nor was he considered for more advanced DVT prophylaxis such as an IVC filter. A pulmonologist was not called in for a consult until patient’s condition deteriorated to the point of intubation. The patient was eventually diagnosed with a pulmonary embolism and died shortly thereafter.

A patient with a hematoma would not be a candidate initially for anti-coagulation. Once there was no further evidence of bleeding, and ideally, the cause of the hematoma understood, prophylactic dosages of subcutaneous heparin or low-molecular weight heparin could be administered to prevent deep venous thrombi (DVT) in a bedridden patient at risk for this common disorder. In a patient with increased risk of DVT who has a relative contraindication for anti-coagulation, sequential compression devices (SCD's) could have been used to decrease his risk of DVT and subsequent PE. This device could have been used upon his admission to the hospital. Once he became short of breath and developed leg swelling, pulmonary embolism should have been considered and a diagnostic study performed. PE is a major killer in this country and most deaths occur without an antemortem diagnosis and the opportunity for effective treatment.

1. What precautions should have been taken with this type of patient?

Location: Colorado B.S., University of Michigan at Ann Arbor M.D., University of Michigan Medical School at Ann Arbor Residency, Chief Resident, Michael Reese Hospital and Medical Center Fellowship, Pulmonary Medical and Critical Care, University of California at San Diego Board Certification: Internal Medicine, Critical Care Medicine, Pulmonary Medicine Member, Fellow of the American College of Chest Physicians Member, American Thoracic Society Member, Colorado Medical Society Published, 7 articles, peer-reviewed publications Former F****** D***** P******** A********* Former S*** P*********** P******** a** C******* C*** Former D******* I******** C*** U*** P*************** L**** M****** C***** Former C**** o* M******* S** J***** H******* Currnent, Assitant Clinical Professor at major medical university Current D******* R********** T****** a* m**** h********* c***** Current D******* o* a**** c******* c*** d********* a* m**** h********* c***** Current F****** a* p******** m******* p****** p******* Current A********* F****** a* 3 m**** h******* c******

Based in Denver, CO, Dr. Schwartz is a graduate of the University of Michigan (BA & MD). He completed his residency in internal medicine at Michael Reese Hospital and Medical Center in Chicago and his fellowship in pulmonary medicine at UCSD Medical Center in San Diego. Dr. Schwartz is board certified in pulmonary medicine, internal medicine and critical care medicine and has more than 30 years experience actively treating patients for pulmonary and respiratory issues. He currently manages Colorado Pulmonary Associates, a private practice, and serves as director of respiratory therapy at St. Lukes Medical Center in Denver,

DVT Prophylaxis Never Utilized Which Results in Deadly Pulmonary Embolism

This case involves a forty-nine-year-old male patient who presented to the hospital complaining of right calf pain and an episode of dizziness associated with a brief loss of consciousness. A CT scan of the head showed the patient had an active bleed in the right cerebellum and a workup for a deep venous thrombosis was positive in the right lower limb. A Bard Recovery Filter was placed as a precaution and the patient was taken off anticoagulants due to his brain bleed. Three days into his admission, the patient complained of shortness of breath and severe chest pain. A pulmonary embolism was suspected and the patient was placed back on anticoagulants with close monitoring of his INR levels. The patient was discharged from the hospital after he was deemed to be medically stable but was found dead two days later in his home. The cause of death was a saddle pulmonary thromboembolus.

I believe this patient was discharged too soon and proper cogulation stability was not yet reached. Patients may have treatment initiated using concomitant warfarin and unfractionated heparin for five days in the hospital, with discharge on warfarin alone when the international normalized ratio (INR) is two. Alternatively, patients may be discharged on concomitant therapy with a LMWH and warfarin for at least five days. The LMWH is then discontinued in the outpatient setting when the INR reaches two.

1. Was this patient monitored long enough before being discharged?

Location: Pennsylvania B.S., University of California at Berkeley M.D., University of California at San Francisco Residency, Categorical Internal Medicine, Hospital of the University of Pennsylvania Fellowship, Pulmonary and Critical Care Medicine, Hospital of the University of Pennsylvania Board Certification: Internal Medicine, Critical Care Medicine, Pulmonary Medicine Member, International Association for the Study of Lung Cancer Member, American College of Chest Physicians Member, American Thoracic Society Published, 50+ abstracts, book chapters, peer-reviewed publications Lectures, 10+ nationally invited lectures Former I********* M******* U********* o* P*********** S***** o* M******* Current D******* L*** N***** P****** a* t** t** m****** u********* Current D******* C******* R******* I************* P********** a** T******* O******* a* m**** m****** s***** Current A******** P******** a* m**** h********* c*****

This extremely qualified, board certified and fellowship trianed pulmonologist currently holds clinical, academic, and research positions at among the finest medical institutions in the nation. He is extensively published in his field, and has given numerous invited lectures nationwide. He also holds a medical patent. These strong qualifications make him highly capable of reviewing the case at hand.

Saddle Embolism Kills Man After Hospital Discharge

This case involves a thirty-two-year-old male who was scheduled for a gastric bypass surgery. The patient had a Bard Recovery Filter, a type of IVC catheter filter, placed prophylactically to prevent the propagation of clots to the lungs and heart. Such precautionary measures were undertaken due to the patient’s increased risk for deep venous thrombosis (DVT). Sometime after the IVC filter was placed, the patient experienced severe bilateral lower extremity swelling and pain. A CT scan of the abdomen and pelvis showed the IVC filter had several prongs extending outside of the vascular lumen of the inferior vena cava. As a result of the perforation of the vena cava by the IVC filter, the patient suffered DVT and complete thrombosis and occlusion of the inferior vena cava, pelvic veins, and lower extremities bilaterally resulting in phlegmasia (or inflammation of the vasculature) and lower extremity ischemia requiring bilateral below-knee amputations.

It is proposed the global stressors of the respiratory and cardiac cycles of the human body cause the IVC filter to develop stress or “fatigue” fractures of the Nitinol (the material of which its made) surface of the device. This results in fracture of one or more of the struts of the device. The struts will then become embedded in the anatomy, causing perforation. The IVC is a very large vein that carries blood back to the heart from the lower extremity. Impediment of venous return can lead to engorgement of the lower extremities, leading to serious complications.

1. Is it possible for an IVF filter to perforate the IVC? If so, what complications can be expected?

Inferior Vena Cava Filter Perforates and Leads to Below-Knee Amputations

This case involves an otherwise healthy patient that presented to his primary care physician with extreme shortness of breath in Utah. He was admitted and was discharged almost immediately with a prescription for Xarelto. Several days later, the patient suffered a stroke while at work. He presented to the emergency room within an hour of the onset of his symptoms. However, he was not given tPA or an IVC Catheter due to the fact that he was on blood thinners. The patient was then transferred to a larger hospital for surgical intervention; however, by the time he arrive the clot had grown too large to operate on. The patient died several days later while in the hospital.

It is possible for the delay for care by the neurosurgeon to have caused the clot to increase in size and thus render it inoperable. The images would determine if that may have caused it. If a patient has a cerebral blood clot, the required response time for intervention is critical. Time is brain; thus, the sooner the better. Currently, the AHA recommends a door-to-puncture of the groin of less than 90 min after hospital arrival. If everything goes right, the recanalization of the vessel should be completed within 120 min of arrival. I participate on Quality Improvement Committees at different institutions. As such, I review cases like this on a frequent basis, and have lectured on this topic before.

1. Could the delay for care by the neurosurgeon have caused the clot to increase in size and thus render it inoperable? 2. What is the required response time for attending to a patient that has a cerebral blood clot for intervention?

Location: Midwest BS, MS University of Buenos Aires, Argentina MD, University of Buenos Aires, Argentina Internship, Internal Medicine, Stroke Hospital of Cook County Residency, Neurology, University of Chicago Fellowship, vascular neurology, University of Illinois at Chicago Board Certified, neurology, vascular neurology Fellow, American Heart Association Member, American Academy of Neurology Publications, 24+ Peer-reviewed articles, 16 Book chapters, 40+ lectures/ presentations Current S***** I******** D******* a* a m**** u********* m****** c***** i* t** m******* Current S****** H*** V******* N******** a* a m**** u********* m****** c***** i* t** m*******

West Coast

Utah

This extremely qualified expert completed his residency in Neurology at the prestigious University of Chicago. He then went on to finish a Vascular Neurology fellowship at the University of Illinois in Chicago. He has published over 24 peer-reviewed articles and book chapters in his field. He is currently the Stroke Medical Director at a major university hospital in the Midwest. The expert leads a comprehensive stroke center that serves as a leading referral tertiary care center for stroke in one of the largest cities in the midwest.

Stroke Patient’s Clot Allegedly Grows to Inoperable Size Due to Delay in Treatment

This case involves a patient who had a medical history of clotting issues who developed a hematoma on her upper right thigh. She presented to the hospital and was admitted with an elevated INR as well as swelling in the affected leg. The patient’s anticoagulation was stopped and vitamin K was given in order to stabilize her INR levels. While her INR was brought back into acceptable ranges, as well as the presence of other reassuring test results, anticoagulation was not resumed. However, doctors did choose to implant an IVC filter. A few weeks later the patient was killed by a massive pulmonary embolism.

In a patient with a history of venous thrombosis, Coumadin should be resumed as soon as the bleeding has stopped. Filters are placed to prevent pulmonary embolism, but do not prevent deep vein thrombosis. In this case the filter may have been tilted allowing a clot from the leg veins to go past the filter into the lungs, the filter may have been in a renal vein, or a clot could have been trapped in the filter and continued to grow on the upstream side of the filter and then broke off, going to the lungs. It is well recognized in the literature that pulmonary embolisms do occur after filter placement. The PREPIC study is the longest duration study showing this. The hospital records will display the size of the filter (it is most likely 30mm). It is not critical to measure the vena cava, since after deployment, the struts expand until they poke into the vena cava wall. Measuring the vena cava takes back seat to making sure the filter is in the vena cava and is properly oriented. Filters have been used to prevent pulmonary embolism for a limited time in patients who cannot be anticoagulated. Prolonged substitution for anticoagulation is not one of the indications for filters. Risks of filters include deep vein thrombosis, clogged filter, migrated filter, and fractures of the filter.

1. How is it determined if Coumadin should be re-started? 2. In a patient with this presentation, under what circumstances should the inferior vena cava be measured? 3. Can an IVC filter ever be used in place of anti-coagulation?

Hematology Expert Opines on Pulmonary Embolism Linked to IVC Filter

This case involves a 56-year-old male patient at risk for pulmonary embolism who was unable to undergo anticoagulation therapy. The patient had an IVC filter implant placed. The patient complained of persistent pain for weeks following the surgery but was told this was normal and not a cause for concern. Within months, the filter migrated and perforated the patient’s vena cava wall. He eventually passed away from complications related to the implant. It was alleged that the implant should have been removed

I have treated patients who have developed the complications described above. I routinely perform IVC filter placements and perform complex retrievals and I am familiar with the FDA guidelines. Our group is one of the national leaders in complex filter retrievals. We established one of the first filter clinics in the country. We see hundreds of CT scans of the abdomen each year with filter struts perforating the inferior vena cava. Perforations of the caval wall are fairly common. Most are of no consequence, but some require intervention. I would need more details on the case, including the degree of migration and perforation.

1. Do you routinely treat patients like the one described above? 2. Are you familiar with the FDA guidelines for timing of the removal of such a filter?

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IVC Filter Expert Witness Case Studies

DVT Prophylaxis Never Utilized Which Results in Deadly Pulmonary Embolism

Saddle Embolism Kills Man After Hospital Discharge

Inferior Vena Cava Filter Perforates and Leads to Below-Knee Amputations

Stroke Patient’s Clot Allegedly Grows to Inoperable Size Due to Delay in Treatment

Hematology Expert Opines on Pulmonary Embolism Linked to IVC Filter

Patient Expires Following Delayed Removal Of Defective Implant

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