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DB was a 22-year-old man who was brought to the hospital after he was found down in the street by police. Witnesses confirmed that DB was a pedestrian involved in a hit-and-run accident with a motor vehicle.
Upon initial assessment at the hospital, DB was awake and alert. Imaging confirmed several rib fractures, a broken right humerus, and two burst fractures of the thoracic spine. In addition, DB had evidence of a pulmonary contusion and a pneumothorax. DB went to the operating room for his spinal injuries and was subsequently admitted by Dr. Hospitalist 1 to the trauma intensive care unit. DB remained intubated and sedated. Dr. Hospitalist 1 documented that DB was at high risk for venous thromboembolism (VTE) and DB received bilateral intermittent pneumatic compression (IPC) of his legs and subcutaneous unfractionated heparin (UFH), 5,000 units every 8 hours, for VTE prophylaxis.
Over the next week, DB underwent open reduction and internal fixation of his right humerus fracture, along with an additional neurosurgical procedure to further stabilize his spine. DB made progress with respect to his pneumothorax and his chest tubes were eventually discontinued. DB was extubated on hospital day 5. On hospital day 7, DB was transferred out of the trauma ICU. For unclear reasons, DB’s prophylactic UFH was discontinued at the time of transfer. DB continued to wear bilateral IPC devices on his legs while he was in bed.
DB began physical therapy, but he had significant pain control issues. On hospital day 11, Dr. Hospitalist 2 restarted UFH, 5,000 units every 8 hours, for VTE prophylaxis. Two days later, DB was noted to have asymmetric edema of his right lower extremity and Dr. Hospitalist 3 obtained a vascular ultrasound. DB was diagnosed with an acute right femoral deep vein thrombosis. Dr. Hospitalist 3 ordered intravenous UFH 80 units/kg bolus followed by an intravenous infusion at 18 units/kg per hour.
The following morning (hospital day 14), the activated partial thromboplastin time was noted to be 82 seconds (1.5-2.5 thromboplastin time control). At approximately 10 a.m. that same day, DB collapsed while he was up to the commode. A code blue was called, but DB did not respond to resuscitation and was pronounced dead at 10:45 a.m. Autopsy confirmed the cause of death as a large saddle pulmonary embolism.
Complaint
DB’s mother was a flight attendant and very familiar with the concept of VTE and VTE prevention. According to her research on the internet, pulmonary embolism (PE) was a "never event" for hospitals and she immediately sought DB’s medical records to ascertain whether appropriate VTE prophylaxis had occurred. Once she discovered that DB had his prophylactic UFH discontinued for 4 days (12 doses of heparin missed), she contacted an attorney and a complaint was filed.
The complaint alleged that the physicians caring for DB failed to apply appropriate VTE prophylaxis commensurate with his high risk, and their collective failure in this regard was the proximate cause for his acute deep vein thrombosis and fatal PE.
Scientific principles
Trauma patients are considered to be at high risk for the development of VTE and some form of prophylaxis is universally recommended. Low-dose UFH given subcutaneously has been shown in multiple studies to safely and effectively decrease the incidence of VTE in high-risk groups. For those patients deemed to be at prohibitive risk for bleeding, nonpharmacologic methods of prevention are recommended. IPC prevents venous thrombosis by enhancing blood flow in the deep veins of the legs, thereby preventing venous stasis. IPC also reduces plasminogen activator inhibitor-1 (PAI-1), thereby increasing endogenous fibrinolytic activity.
Despite appropriate prophylaxis, acute VTE can still occur. Full-dose anticoagulant therapy is indicated for patients with symptomatic VTE, and anticoagulation is usually achieved initially with intravenous UFH or weight-adjusted doses of subcutaneous low-molecular-weight heparin. A 2010 meta-analysis of 13 prospective cohort studies and 56 randomized clinical trials demonstrated that the rate of recurrent fatal VTE following the appropriate initiation of full-dose anticoagulant therapy was just 0.4% (Ann. Intern. Med.2010;152:578-89).
Complaint rebuttal and discussion
The defense argued that the approach to VTE prophylaxis in a patient such as DB was a matter of clinical judgment and that, regardless of the strategy applied, acute events can and do occur. The defense highlighted the fact that DB was persistently anemic following his ICU transfer and that the physicians were concerned about possible hemorrhage. The defense also pointed out that DB continued to receive mechanical prophylaxis, which was appropriate.
In addition, the defense explained that DB had his acute DVT diagnosed immediately and he received appropriate full-dose anticoagulation prior to his death; DB therefore had less than a 0.4% chance of dying from VTE, according to the literature. Defense experts opined that, since DB went on to succumb to fatal PE despite adequate therapy, he was somehow different than those who typically respond to treatment and/or VTE prevention. In other words, the defense experts opined that DB would have developed and ultimately died from VTE regardless of what the physicians did or didn’t do in this case.
Conclusion
At the time of DB’s transition of care from the ICU to the regular nursing floor, there was no chart documentation to support the notion that his physicians were concerned about hemorrhage. It is more likely than not that DB had his subcutaneous UFH discontinued for several days by mistake.
Whether DB would still have suffered an acute DVT (along with a fatal PE) had the UFH prophylaxis not been interrupted is unknown. Sadly, DB defied the odds when he did not respond to treatment following the diagnosis of his acute DVT. At the end of the day, the plaintiffs were unable to find an expert to rebut the opinions of the defense in this case and, as a result, the case was dismissed without prejudice.
Dr. Michota is director of academic affairs in the hospital medicine department at the Cleveland Clinic and medical editor of Hospitalist News. He has been involved in peer review both within and outside the legal system.
DB was a 22-year-old man who was brought to the hospital after he was found down in the street by police. Witnesses confirmed that DB was a pedestrian involved in a hit-and-run accident with a motor vehicle.
Upon initial assessment at the hospital, DB was awake and alert. Imaging confirmed several rib fractures, a broken right humerus, and two burst fractures of the thoracic spine. In addition, DB had evidence of a pulmonary contusion and a pneumothorax. DB went to the operating room for his spinal injuries and was subsequently admitted by Dr. Hospitalist 1 to the trauma intensive care unit. DB remained intubated and sedated. Dr. Hospitalist 1 documented that DB was at high risk for venous thromboembolism (VTE) and DB received bilateral intermittent pneumatic compression (IPC) of his legs and subcutaneous unfractionated heparin (UFH), 5,000 units every 8 hours, for VTE prophylaxis.
Over the next week, DB underwent open reduction and internal fixation of his right humerus fracture, along with an additional neurosurgical procedure to further stabilize his spine. DB made progress with respect to his pneumothorax and his chest tubes were eventually discontinued. DB was extubated on hospital day 5. On hospital day 7, DB was transferred out of the trauma ICU. For unclear reasons, DB’s prophylactic UFH was discontinued at the time of transfer. DB continued to wear bilateral IPC devices on his legs while he was in bed.
DB began physical therapy, but he had significant pain control issues. On hospital day 11, Dr. Hospitalist 2 restarted UFH, 5,000 units every 8 hours, for VTE prophylaxis. Two days later, DB was noted to have asymmetric edema of his right lower extremity and Dr. Hospitalist 3 obtained a vascular ultrasound. DB was diagnosed with an acute right femoral deep vein thrombosis. Dr. Hospitalist 3 ordered intravenous UFH 80 units/kg bolus followed by an intravenous infusion at 18 units/kg per hour.
The following morning (hospital day 14), the activated partial thromboplastin time was noted to be 82 seconds (1.5-2.5 thromboplastin time control). At approximately 10 a.m. that same day, DB collapsed while he was up to the commode. A code blue was called, but DB did not respond to resuscitation and was pronounced dead at 10:45 a.m. Autopsy confirmed the cause of death as a large saddle pulmonary embolism.
Complaint
DB’s mother was a flight attendant and very familiar with the concept of VTE and VTE prevention. According to her research on the internet, pulmonary embolism (PE) was a "never event" for hospitals and she immediately sought DB’s medical records to ascertain whether appropriate VTE prophylaxis had occurred. Once she discovered that DB had his prophylactic UFH discontinued for 4 days (12 doses of heparin missed), she contacted an attorney and a complaint was filed.
The complaint alleged that the physicians caring for DB failed to apply appropriate VTE prophylaxis commensurate with his high risk, and their collective failure in this regard was the proximate cause for his acute deep vein thrombosis and fatal PE.
Scientific principles
Trauma patients are considered to be at high risk for the development of VTE and some form of prophylaxis is universally recommended. Low-dose UFH given subcutaneously has been shown in multiple studies to safely and effectively decrease the incidence of VTE in high-risk groups. For those patients deemed to be at prohibitive risk for bleeding, nonpharmacologic methods of prevention are recommended. IPC prevents venous thrombosis by enhancing blood flow in the deep veins of the legs, thereby preventing venous stasis. IPC also reduces plasminogen activator inhibitor-1 (PAI-1), thereby increasing endogenous fibrinolytic activity.
Despite appropriate prophylaxis, acute VTE can still occur. Full-dose anticoagulant therapy is indicated for patients with symptomatic VTE, and anticoagulation is usually achieved initially with intravenous UFH or weight-adjusted doses of subcutaneous low-molecular-weight heparin. A 2010 meta-analysis of 13 prospective cohort studies and 56 randomized clinical trials demonstrated that the rate of recurrent fatal VTE following the appropriate initiation of full-dose anticoagulant therapy was just 0.4% (Ann. Intern. Med.2010;152:578-89).
Complaint rebuttal and discussion
The defense argued that the approach to VTE prophylaxis in a patient such as DB was a matter of clinical judgment and that, regardless of the strategy applied, acute events can and do occur. The defense highlighted the fact that DB was persistently anemic following his ICU transfer and that the physicians were concerned about possible hemorrhage. The defense also pointed out that DB continued to receive mechanical prophylaxis, which was appropriate.
In addition, the defense explained that DB had his acute DVT diagnosed immediately and he received appropriate full-dose anticoagulation prior to his death; DB therefore had less than a 0.4% chance of dying from VTE, according to the literature. Defense experts opined that, since DB went on to succumb to fatal PE despite adequate therapy, he was somehow different than those who typically respond to treatment and/or VTE prevention. In other words, the defense experts opined that DB would have developed and ultimately died from VTE regardless of what the physicians did or didn’t do in this case.
Conclusion
At the time of DB’s transition of care from the ICU to the regular nursing floor, there was no chart documentation to support the notion that his physicians were concerned about hemorrhage. It is more likely than not that DB had his subcutaneous UFH discontinued for several days by mistake.
Whether DB would still have suffered an acute DVT (along with a fatal PE) had the UFH prophylaxis not been interrupted is unknown. Sadly, DB defied the odds when he did not respond to treatment following the diagnosis of his acute DVT. At the end of the day, the plaintiffs were unable to find an expert to rebut the opinions of the defense in this case and, as a result, the case was dismissed without prejudice.
Dr. Michota is director of academic affairs in the hospital medicine department at the Cleveland Clinic and medical editor of Hospitalist News. He has been involved in peer review both within and outside the legal system.
DB was a 22-year-old man who was brought to the hospital after he was found down in the street by police. Witnesses confirmed that DB was a pedestrian involved in a hit-and-run accident with a motor vehicle.
Upon initial assessment at the hospital, DB was awake and alert. Imaging confirmed several rib fractures, a broken right humerus, and two burst fractures of the thoracic spine. In addition, DB had evidence of a pulmonary contusion and a pneumothorax. DB went to the operating room for his spinal injuries and was subsequently admitted by Dr. Hospitalist 1 to the trauma intensive care unit. DB remained intubated and sedated. Dr. Hospitalist 1 documented that DB was at high risk for venous thromboembolism (VTE) and DB received bilateral intermittent pneumatic compression (IPC) of his legs and subcutaneous unfractionated heparin (UFH), 5,000 units every 8 hours, for VTE prophylaxis.
Over the next week, DB underwent open reduction and internal fixation of his right humerus fracture, along with an additional neurosurgical procedure to further stabilize his spine. DB made progress with respect to his pneumothorax and his chest tubes were eventually discontinued. DB was extubated on hospital day 5. On hospital day 7, DB was transferred out of the trauma ICU. For unclear reasons, DB’s prophylactic UFH was discontinued at the time of transfer. DB continued to wear bilateral IPC devices on his legs while he was in bed.
DB began physical therapy, but he had significant pain control issues. On hospital day 11, Dr. Hospitalist 2 restarted UFH, 5,000 units every 8 hours, for VTE prophylaxis. Two days later, DB was noted to have asymmetric edema of his right lower extremity and Dr. Hospitalist 3 obtained a vascular ultrasound. DB was diagnosed with an acute right femoral deep vein thrombosis. Dr. Hospitalist 3 ordered intravenous UFH 80 units/kg bolus followed by an intravenous infusion at 18 units/kg per hour.
The following morning (hospital day 14), the activated partial thromboplastin time was noted to be 82 seconds (1.5-2.5 thromboplastin time control). At approximately 10 a.m. that same day, DB collapsed while he was up to the commode. A code blue was called, but DB did not respond to resuscitation and was pronounced dead at 10:45 a.m. Autopsy confirmed the cause of death as a large saddle pulmonary embolism.
Complaint
DB’s mother was a flight attendant and very familiar with the concept of VTE and VTE prevention. According to her research on the internet, pulmonary embolism (PE) was a "never event" for hospitals and she immediately sought DB’s medical records to ascertain whether appropriate VTE prophylaxis had occurred. Once she discovered that DB had his prophylactic UFH discontinued for 4 days (12 doses of heparin missed), she contacted an attorney and a complaint was filed.
The complaint alleged that the physicians caring for DB failed to apply appropriate VTE prophylaxis commensurate with his high risk, and their collective failure in this regard was the proximate cause for his acute deep vein thrombosis and fatal PE.
Scientific principles
Trauma patients are considered to be at high risk for the development of VTE and some form of prophylaxis is universally recommended. Low-dose UFH given subcutaneously has been shown in multiple studies to safely and effectively decrease the incidence of VTE in high-risk groups. For those patients deemed to be at prohibitive risk for bleeding, nonpharmacologic methods of prevention are recommended. IPC prevents venous thrombosis by enhancing blood flow in the deep veins of the legs, thereby preventing venous stasis. IPC also reduces plasminogen activator inhibitor-1 (PAI-1), thereby increasing endogenous fibrinolytic activity.
Despite appropriate prophylaxis, acute VTE can still occur. Full-dose anticoagulant therapy is indicated for patients with symptomatic VTE, and anticoagulation is usually achieved initially with intravenous UFH or weight-adjusted doses of subcutaneous low-molecular-weight heparin. A 2010 meta-analysis of 13 prospective cohort studies and 56 randomized clinical trials demonstrated that the rate of recurrent fatal VTE following the appropriate initiation of full-dose anticoagulant therapy was just 0.4% (Ann. Intern. Med.2010;152:578-89).
Complaint rebuttal and discussion
The defense argued that the approach to VTE prophylaxis in a patient such as DB was a matter of clinical judgment and that, regardless of the strategy applied, acute events can and do occur. The defense highlighted the fact that DB was persistently anemic following his ICU transfer and that the physicians were concerned about possible hemorrhage. The defense also pointed out that DB continued to receive mechanical prophylaxis, which was appropriate.
In addition, the defense explained that DB had his acute DVT diagnosed immediately and he received appropriate full-dose anticoagulation prior to his death; DB therefore had less than a 0.4% chance of dying from VTE, according to the literature. Defense experts opined that, since DB went on to succumb to fatal PE despite adequate therapy, he was somehow different than those who typically respond to treatment and/or VTE prevention. In other words, the defense experts opined that DB would have developed and ultimately died from VTE regardless of what the physicians did or didn’t do in this case.
Conclusion
At the time of DB’s transition of care from the ICU to the regular nursing floor, there was no chart documentation to support the notion that his physicians were concerned about hemorrhage. It is more likely than not that DB had his subcutaneous UFH discontinued for several days by mistake.
Whether DB would still have suffered an acute DVT (along with a fatal PE) had the UFH prophylaxis not been interrupted is unknown. Sadly, DB defied the odds when he did not respond to treatment following the diagnosis of his acute DVT. At the end of the day, the plaintiffs were unable to find an expert to rebut the opinions of the defense in this case and, as a result, the case was dismissed without prejudice.
Dr. Michota is director of academic affairs in the hospital medicine department at the Cleveland Clinic and medical editor of Hospitalist News. He has been involved in peer review both within and outside the legal system.
