Bleeding complications following femoral angiographic access

Bleeding complications following angiographic interventions have recently become an increasing cause of medical malpractice litigation. The reason for this increase is likely a result of several factors including the controversy surrounding the multiple approaches that are currently employed for the treatment of this type of bleeding, as well as the significant morbidity and mortality associated with these treatment paradigms. Allegations in these lawsuits usually include failure to diagnose, failure to treat, failure to transfuse, negligence in the use of an endovascular approach, and negligence in open surgical treatment. Physical examination, close observation, and an aggressive approach to intervention are necessary if litigation is to be avoided in this patient population.

Case 1

The patient underwent cardiac catheterization with placement of a coronary stent. The patient was placed on Integrilin. Following the catheterization, the patient had multiple episodes of hypotension. Each episode responded to fluid boluses and transfusion. No surgical consultation was obtained. The patient’s hemoglobin never fell below 8 grams. The patient was transfused approximately 8 units of blood. The patient’s Integrilin was discontinued. However, the patient progressed to multisystem organ failure and died. Autopsy revealed a massive hematoma of the retroperitoneum and a patent coronary stent. A medical malpractice suit was filed. The case was settled.

Case 2

A patient underwent cardiac catheterization and subsequently developed severe bleeding. She received approximately 10 units of blood prior to vascular surgical consultation. By the time the vascular surgeon saw the patient, the patient was intubated and on vasopressors. The vascular surgeon stated that the patient was not a candidate for surgery. The patient subsequently died. A lawsuit was filed against both the cardiologist and the vascular surgeon. This case was settled by both physicians.

Case 3

A cardiologist calls a vascular surgeon who is at home at 10 p.m. to let her know that he has a patient with a retroperitoneal hematoma following a cardiac cath. He informs the surgeon that the patient is stable. He “just wants her to be aware in case the patient’s condition deteriorates.”

During the night the patient has repeated hypotensive episodes which the cardiologist manages with transfusions. At 5 a.m. the patient arrests and is resuscitated. The surgeon is called, and she takes the patient to surgery but the patient succumbs. The surgeon is sued for not coming in to see the patient and being more involved during the night.

The jury finds in favor of the surgeon. However, the trial took 2 weeks during which time the surgeon had to attend the deliberations and so she was unable work.

Discussion

Unfortunately, the above examples represent the all too often complication of postprocedure bleeding following femoral access.

In case 1, early exploration would more likely than not, and within a reasonable degree of medical certainty, prevented the patient’s death. The presumption is that the patient died from the untreated complication of postcatheterization hemorrhage. The defendant’s claim that the patient’s hemoglobin was never lower than 8 mg did not serve as an adequate defense. Even if the patient was found at autopsy to have an occluded stent which caused an acute MI, the plaintiff’s attorney would likely argue successfully that if the bleeding had been appropriately treated, the stent would have remained patent. The cardiologist was found culpable for not consulting a vascular surgeon.

In the second example, the plaintiff’s expert explained to the jury that without surgery, the patient would continue to bleed and certainly die. He went on to opine that the only possible chance of the patient surviving was with surgical intervention, and this chance was denied to the patient by the vascular surgeon who refused to operate. In these types of cases, the surgeon incorrectly believes that he/she can avoid liability and involvement in the case by not operating on the patient. However, as this case demonstrated, the surgeon is still likely to be named as a defendant in the law suit.

The third case illustrates two common pitfalls for the vascular surgeon and perhaps represents the most dangerous situation for the vascular surgeon. The first pitfall occurs when the vascular surgeon relies on telephone information without examining the patient. Secondly, as in this case, a formal consult was never initiated by the cardiologist. The surgeon incorrectly assumed that because no formal consult was placed she had no liability. However, according to the plaintiff’s expert, since she had been informed about the patient she should have come in to see the patient.

Had she done so, he alleged she would have realized that the patient required an intervention either with a covered stent or a surgical repair of the bleeding external iliac artery. Clearly, the fact that no formal consult was placed in the chart did not prevent the vascular surgeon from being a named defendant in this case.

Several steps should be taken if a physician is to minimize the risk of being named as a defendant in a lawsuit involving postangiographic intervention bleeding. First, if the physician is a not a surgeon, surgical consultation should be obtained as soon as postprocedure bleeding is suspected. Second, surgeons should pursue an aggressive approach to the treatment of this complication. Whereas it may be reasonable to treat a single episode of hypotension with fluid or blood transfusion, unless there are mitigating circumstances, any patient who develops a second episode of hypotension in the face of ongoing bleeding should undergo intervention. Furthermore, there must be clear documentation as to why a particular approach (endovascular versus open repair) was chosen. A medical physician’s inability to perform an open approach or a surgeon’s inability to perform an endovascular approach are not sustainable defenses.

Surgeons who are consulted late in the patient’s clinical course, prior to intervention, should document the patient’s poor prognosis and make it clear that no matter what is done the patient is unlikely to survive.

However, in most situations, the defense that a patient with ongoing bleeding was too unstable to treat is likely to fail.

Access site bleeding following percutaneous interventions is often a readily treatable complication. A low threshold for intervention, cooperation among vascular specialists, and, as always, clear documentation will go a long way to keep physicians working and out of the courtroom.

Dr. Brown is associate editor of Vascular Specialist. Dr. Samson is the medical editor, Vascular Specialist.

 The opinions expressed by the authors neither imply nor establish a standard 
of care.

Bleeding complications following angiographic interventions have recently become an increasing cause of medical malpractice litigation. The reason for this increase is likely a result of several factors including the controversy surrounding the multiple approaches that are currently employed for the treatment of this type of bleeding, as well as the significant morbidity and mortality associated with these treatment paradigms. Allegations in these lawsuits usually include failure to diagnose, failure to treat, failure to transfuse, negligence in the use of an endovascular approach, and negligence in open surgical treatment. Physical examination, close observation, and an aggressive approach to intervention are necessary if litigation is to be avoided in this patient population.

Case 1

The patient underwent cardiac catheterization with placement of a coronary stent. The patient was placed on Integrilin. Following the catheterization, the patient had multiple episodes of hypotension. Each episode responded to fluid boluses and transfusion. No surgical consultation was obtained. The patient’s hemoglobin never fell below 8 grams. The patient was transfused approximately 8 units of blood. The patient’s Integrilin was discontinued. However, the patient progressed to multisystem organ failure and died. Autopsy revealed a massive hematoma of the retroperitoneum and a patent coronary stent. A medical malpractice suit was filed. The case was settled.

Case 2

A patient underwent cardiac catheterization and subsequently developed severe bleeding. She received approximately 10 units of blood prior to vascular surgical consultation. By the time the vascular surgeon saw the patient, the patient was intubated and on vasopressors. The vascular surgeon stated that the patient was not a candidate for surgery. The patient subsequently died. A lawsuit was filed against both the cardiologist and the vascular surgeon. This case was settled by both physicians.

Case 3

A cardiologist calls a vascular surgeon who is at home at 10 p.m. to let her know that he has a patient with a retroperitoneal hematoma following a cardiac cath. He informs the surgeon that the patient is stable. He “just wants her to be aware in case the patient’s condition deteriorates.”

During the night the patient has repeated hypotensive episodes which the cardiologist manages with transfusions. At 5 a.m. the patient arrests and is resuscitated. The surgeon is called, and she takes the patient to surgery but the patient succumbs. The surgeon is sued for not coming in to see the patient and being more involved during the night.

The jury finds in favor of the surgeon. However, the trial took 2 weeks during which time the surgeon had to attend the deliberations and so she was unable work.

Discussion

Unfortunately, the above examples represent the all too often complication of postprocedure bleeding following femoral access.

In case 1, early exploration would more likely than not, and within a reasonable degree of medical certainty, prevented the patient’s death. The presumption is that the patient died from the untreated complication of postcatheterization hemorrhage. The defendant’s claim that the patient’s hemoglobin was never lower than 8 mg did not serve as an adequate defense. Even if the patient was found at autopsy to have an occluded stent which caused an acute MI, the plaintiff’s attorney would likely argue successfully that if the bleeding had been appropriately treated, the stent would have remained patent. The cardiologist was found culpable for not consulting a vascular surgeon.

In the second example, the plaintiff’s expert explained to the jury that without surgery, the patient would continue to bleed and certainly die. He went on to opine that the only possible chance of the patient surviving was with surgical intervention, and this chance was denied to the patient by the vascular surgeon who refused to operate. In these types of cases, the surgeon incorrectly believes that he/she can avoid liability and involvement in the case by not operating on the patient. However, as this case demonstrated, the surgeon is still likely to be named as a defendant in the law suit.

The third case illustrates two common pitfalls for the vascular surgeon and perhaps represents the most dangerous situation for the vascular surgeon. The first pitfall occurs when the vascular surgeon relies on telephone information without examining the patient. Secondly, as in this case, a formal consult was never initiated by the cardiologist. The surgeon incorrectly assumed that because no formal consult was placed she had no liability. However, according to the plaintiff’s expert, since she had been informed about the patient she should have come in to see the patient.

Had she done so, he alleged she would have realized that the patient required an intervention either with a covered stent or a surgical repair of the bleeding external iliac artery. Clearly, the fact that no formal consult was placed in the chart did not prevent the vascular surgeon from being a named defendant in this case.

Several steps should be taken if a physician is to minimize the risk of being named as a defendant in a lawsuit involving postangiographic intervention bleeding. First, if the physician is a not a surgeon, surgical consultation should be obtained as soon as postprocedure bleeding is suspected. Second, surgeons should pursue an aggressive approach to the treatment of this complication. Whereas it may be reasonable to treat a single episode of hypotension with fluid or blood transfusion, unless there are mitigating circumstances, any patient who develops a second episode of hypotension in the face of ongoing bleeding should undergo intervention. Furthermore, there must be clear documentation as to why a particular approach (endovascular versus open repair) was chosen. A medical physician’s inability to perform an open approach or a surgeon’s inability to perform an endovascular approach are not sustainable defenses.

Surgeons who are consulted late in the patient’s clinical course, prior to intervention, should document the patient’s poor prognosis and make it clear that no matter what is done the patient is unlikely to survive.

However, in most situations, the defense that a patient with ongoing bleeding was too unstable to treat is likely to fail.

Access site bleeding following percutaneous interventions is often a readily treatable complication. A low threshold for intervention, cooperation among vascular specialists, and, as always, clear documentation will go a long way to keep physicians working and out of the courtroom.

Dr. Brown is associate editor of Vascular Specialist. Dr. Samson is the medical editor, Vascular Specialist.

 The opinions expressed by the authors neither imply nor establish a standard 
of care.

Bleeding complications following angiographic interventions have recently become an increasing cause of medical malpractice litigation. The reason for this increase is likely a result of several factors including the controversy surrounding the multiple approaches that are currently employed for the treatment of this type of bleeding, as well as the significant morbidity and mortality associated with these treatment paradigms. Allegations in these lawsuits usually include failure to diagnose, failure to treat, failure to transfuse, negligence in the use of an endovascular approach, and negligence in open surgical treatment. Physical examination, close observation, and an aggressive approach to intervention are necessary if litigation is to be avoided in this patient population.

Case 1

The patient underwent cardiac catheterization with placement of a coronary stent. The patient was placed on Integrilin. Following the catheterization, the patient had multiple episodes of hypotension. Each episode responded to fluid boluses and transfusion. No surgical consultation was obtained. The patient’s hemoglobin never fell below 8 grams. The patient was transfused approximately 8 units of blood. The patient’s Integrilin was discontinued. However, the patient progressed to multisystem organ failure and died. Autopsy revealed a massive hematoma of the retroperitoneum and a patent coronary stent. A medical malpractice suit was filed. The case was settled.

Case 2

A patient underwent cardiac catheterization and subsequently developed severe bleeding. She received approximately 10 units of blood prior to vascular surgical consultation. By the time the vascular surgeon saw the patient, the patient was intubated and on vasopressors. The vascular surgeon stated that the patient was not a candidate for surgery. The patient subsequently died. A lawsuit was filed against both the cardiologist and the vascular surgeon. This case was settled by both physicians.

Case 3

A cardiologist calls a vascular surgeon who is at home at 10 p.m. to let her know that he has a patient with a retroperitoneal hematoma following a cardiac cath. He informs the surgeon that the patient is stable. He “just wants her to be aware in case the patient’s condition deteriorates.”

During the night the patient has repeated hypotensive episodes which the cardiologist manages with transfusions. At 5 a.m. the patient arrests and is resuscitated. The surgeon is called, and she takes the patient to surgery but the patient succumbs. The surgeon is sued for not coming in to see the patient and being more involved during the night.

The jury finds in favor of the surgeon. However, the trial took 2 weeks during which time the surgeon had to attend the deliberations and so she was unable work.

Discussion

Unfortunately, the above examples represent the all too often complication of postprocedure bleeding following femoral access.

In case 1, early exploration would more likely than not, and within a reasonable degree of medical certainty, prevented the patient’s death. The presumption is that the patient died from the untreated complication of postcatheterization hemorrhage. The defendant’s claim that the patient’s hemoglobin was never lower than 8 mg did not serve as an adequate defense. Even if the patient was found at autopsy to have an occluded stent which caused an acute MI, the plaintiff’s attorney would likely argue successfully that if the bleeding had been appropriately treated, the stent would have remained patent. The cardiologist was found culpable for not consulting a vascular surgeon.

In the second example, the plaintiff’s expert explained to the jury that without surgery, the patient would continue to bleed and certainly die. He went on to opine that the only possible chance of the patient surviving was with surgical intervention, and this chance was denied to the patient by the vascular surgeon who refused to operate. In these types of cases, the surgeon incorrectly believes that he/she can avoid liability and involvement in the case by not operating on the patient. However, as this case demonstrated, the surgeon is still likely to be named as a defendant in the law suit.

The third case illustrates two common pitfalls for the vascular surgeon and perhaps represents the most dangerous situation for the vascular surgeon. The first pitfall occurs when the vascular surgeon relies on telephone information without examining the patient. Secondly, as in this case, a formal consult was never initiated by the cardiologist. The surgeon incorrectly assumed that because no formal consult was placed she had no liability. However, according to the plaintiff’s expert, since she had been informed about the patient she should have come in to see the patient.

Had she done so, he alleged she would have realized that the patient required an intervention either with a covered stent or a surgical repair of the bleeding external iliac artery. Clearly, the fact that no formal consult was placed in the chart did not prevent the vascular surgeon from being a named defendant in this case.

Several steps should be taken if a physician is to minimize the risk of being named as a defendant in a lawsuit involving postangiographic intervention bleeding. First, if the physician is a not a surgeon, surgical consultation should be obtained as soon as postprocedure bleeding is suspected. Second, surgeons should pursue an aggressive approach to the treatment of this complication. Whereas it may be reasonable to treat a single episode of hypotension with fluid or blood transfusion, unless there are mitigating circumstances, any patient who develops a second episode of hypotension in the face of ongoing bleeding should undergo intervention. Furthermore, there must be clear documentation as to why a particular approach (endovascular versus open repair) was chosen. A medical physician’s inability to perform an open approach or a surgeon’s inability to perform an endovascular approach are not sustainable defenses.

Surgeons who are consulted late in the patient’s clinical course, prior to intervention, should document the patient’s poor prognosis and make it clear that no matter what is done the patient is unlikely to survive.

However, in most situations, the defense that a patient with ongoing bleeding was too unstable to treat is likely to fail.

Access site bleeding following percutaneous interventions is often a readily treatable complication. A low threshold for intervention, cooperation among vascular specialists, and, as always, clear documentation will go a long way to keep physicians working and out of the courtroom.

Dr. Brown is associate editor of Vascular Specialist. Dr. Samson is the medical editor, Vascular Specialist.

 The opinions expressed by the authors neither imply nor establish a standard 
of care.