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Protocol helped identify hospitalized children at risk for VTE
SAN DIEGO – Following simple institutional care guidelines helped clinicians identify pediatric patients at moderate-to-severe risk of venous thromboembolism (VTE), results from a single-center study showed.
“Hospital-acquired VTE is on the rise in the pediatric population,” lead study author Emily Southard, MD, said at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “This consists of a DVT or [pulmonary embolism] 48 hours or more after admission, or any time at the site of a central venous catheter.”
One published study found a 70% increased incidence in the pediatric population from 2001-2007 (Pediatrics 2009;124[4]:1001-8). More than half of the children in that study (63%) had at least one coexisting complex medical condition, with malignancy being the most common.
Hospital-acquired VTE cases tend to harbor a number of complications, said Dr. Southard, who is a pediatric hematology/oncology fellow at Children’s Hospital Colorado, Aurora. For example, 15%-20% of patients with a DVT will have a pulmonary embolism (PE) as well, 26% of patients with upper or lower extremity DVT develop post-thrombotic syndrome, and 3% of patients with PE develop chronic pulmonary hypertension.
“Medical costs are also impacted,” she said. “The cost for a hospital-acquired VTE in pediatrics increased the length of stay by about 8 days and increased the cost of hospital admission by more than $27,000.”
Known risk factors for VTE in this patient population include ICU admission (Odds Ratio, 2.14), presence of a central venous catheter (OR, 2.12), mechanical ventilation (OR, 1.56), and prolonged admission (OR, 1.03 for each day).
Risk factors in pediatric trauma patients include ICU admission (OR, 6.25), transfusion of blood products (OR, 2.1), lower extremity fracture (OR, 1.8), and neurosurgery (OR, 2.13). She and her associates hypothesized that understanding the relative contributions of clinical, biological, and genetic risk factors for pediatric VTE would help appropriately risk-stratify patients and allow better prophylactic approaches.
In 2012, Children’s Hospital Colorado implemented a VTE risk assessment tool as part of a hospital-wide patient safety initiative. The assessment is triggered via an Epic Best Practice Advisory to complete in certain higher-risk patients, including ICU patients, hematology/oncology floor patients, any patients with a central line catheter, and those who are over age 12 and obese.
Clinicians also assess for risk factors such as significant infection, recent surgery, and personal or family history of thrombophilia. Next, they classify each patient’s risk of hospital-acquired VTE as high, moderate, or low risk.
In a pilot study, Dr. Southard and her associates set out to validate the accuracy of the institution’s VTE risk assessment tool since it was implemented in 2012. She presented findings from 215 hospital-acquired VTE cases in patients younger than age 18, compared with age-matched inpatient controls. Data from patients under 6 months of age is available after October 2016, coinciding with a change in definition of pediatric hospital-acquired VTE.
Most hospital-acquired VTE patients (77.2%) ranged in age from 1-17 years. The number of patients admitted for a trauma diagnosis was similar between VTE cases and controls (7.4% vs. 7.9%, respectively). However, compared with controls, a significantly greater number of VTE cases were immobile (41.8% vs. 10.3%, respectively), required ICU admission (86.4% vs. 26.5%), had a central venous catheter (80.4% vs. 10.9%), had a positive blood culture (16.7% vs. 1.9%), required surgery or a medical procedure (57.7% vs. 36.7%), and had a longer procedure time (a mean of 151 vs. 133 minutes).
The researchers also found that upon initial admission, 7.9% of VTE cases were identified as high risk and another 21.9% were identified as moderate risk, compared with 1.2% and 3.7% in the controls, respectively.
“Patients identified as moderate or high risk for VTE were generally more medically complex patients,” Dr. Southard said.
Future directions of this project include expanding the patient population that has a risk assessment performed.
Dr. Southard reported having no financial disclosures.
SOURCE: Southard E et al. THSNA 2018.
SAN DIEGO – Following simple institutional care guidelines helped clinicians identify pediatric patients at moderate-to-severe risk of venous thromboembolism (VTE), results from a single-center study showed.
“Hospital-acquired VTE is on the rise in the pediatric population,” lead study author Emily Southard, MD, said at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “This consists of a DVT or [pulmonary embolism] 48 hours or more after admission, or any time at the site of a central venous catheter.”
One published study found a 70% increased incidence in the pediatric population from 2001-2007 (Pediatrics 2009;124[4]:1001-8). More than half of the children in that study (63%) had at least one coexisting complex medical condition, with malignancy being the most common.
Hospital-acquired VTE cases tend to harbor a number of complications, said Dr. Southard, who is a pediatric hematology/oncology fellow at Children’s Hospital Colorado, Aurora. For example, 15%-20% of patients with a DVT will have a pulmonary embolism (PE) as well, 26% of patients with upper or lower extremity DVT develop post-thrombotic syndrome, and 3% of patients with PE develop chronic pulmonary hypertension.
“Medical costs are also impacted,” she said. “The cost for a hospital-acquired VTE in pediatrics increased the length of stay by about 8 days and increased the cost of hospital admission by more than $27,000.”
Known risk factors for VTE in this patient population include ICU admission (Odds Ratio, 2.14), presence of a central venous catheter (OR, 2.12), mechanical ventilation (OR, 1.56), and prolonged admission (OR, 1.03 for each day).
Risk factors in pediatric trauma patients include ICU admission (OR, 6.25), transfusion of blood products (OR, 2.1), lower extremity fracture (OR, 1.8), and neurosurgery (OR, 2.13). She and her associates hypothesized that understanding the relative contributions of clinical, biological, and genetic risk factors for pediatric VTE would help appropriately risk-stratify patients and allow better prophylactic approaches.
In 2012, Children’s Hospital Colorado implemented a VTE risk assessment tool as part of a hospital-wide patient safety initiative. The assessment is triggered via an Epic Best Practice Advisory to complete in certain higher-risk patients, including ICU patients, hematology/oncology floor patients, any patients with a central line catheter, and those who are over age 12 and obese.
Clinicians also assess for risk factors such as significant infection, recent surgery, and personal or family history of thrombophilia. Next, they classify each patient’s risk of hospital-acquired VTE as high, moderate, or low risk.
In a pilot study, Dr. Southard and her associates set out to validate the accuracy of the institution’s VTE risk assessment tool since it was implemented in 2012. She presented findings from 215 hospital-acquired VTE cases in patients younger than age 18, compared with age-matched inpatient controls. Data from patients under 6 months of age is available after October 2016, coinciding with a change in definition of pediatric hospital-acquired VTE.
Most hospital-acquired VTE patients (77.2%) ranged in age from 1-17 years. The number of patients admitted for a trauma diagnosis was similar between VTE cases and controls (7.4% vs. 7.9%, respectively). However, compared with controls, a significantly greater number of VTE cases were immobile (41.8% vs. 10.3%, respectively), required ICU admission (86.4% vs. 26.5%), had a central venous catheter (80.4% vs. 10.9%), had a positive blood culture (16.7% vs. 1.9%), required surgery or a medical procedure (57.7% vs. 36.7%), and had a longer procedure time (a mean of 151 vs. 133 minutes).
The researchers also found that upon initial admission, 7.9% of VTE cases were identified as high risk and another 21.9% were identified as moderate risk, compared with 1.2% and 3.7% in the controls, respectively.
“Patients identified as moderate or high risk for VTE were generally more medically complex patients,” Dr. Southard said.
Future directions of this project include expanding the patient population that has a risk assessment performed.
Dr. Southard reported having no financial disclosures.
SOURCE: Southard E et al. THSNA 2018.
SAN DIEGO – Following simple institutional care guidelines helped clinicians identify pediatric patients at moderate-to-severe risk of venous thromboembolism (VTE), results from a single-center study showed.
“Hospital-acquired VTE is on the rise in the pediatric population,” lead study author Emily Southard, MD, said at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “This consists of a DVT or [pulmonary embolism] 48 hours or more after admission, or any time at the site of a central venous catheter.”
One published study found a 70% increased incidence in the pediatric population from 2001-2007 (Pediatrics 2009;124[4]:1001-8). More than half of the children in that study (63%) had at least one coexisting complex medical condition, with malignancy being the most common.
Hospital-acquired VTE cases tend to harbor a number of complications, said Dr. Southard, who is a pediatric hematology/oncology fellow at Children’s Hospital Colorado, Aurora. For example, 15%-20% of patients with a DVT will have a pulmonary embolism (PE) as well, 26% of patients with upper or lower extremity DVT develop post-thrombotic syndrome, and 3% of patients with PE develop chronic pulmonary hypertension.
“Medical costs are also impacted,” she said. “The cost for a hospital-acquired VTE in pediatrics increased the length of stay by about 8 days and increased the cost of hospital admission by more than $27,000.”
Known risk factors for VTE in this patient population include ICU admission (Odds Ratio, 2.14), presence of a central venous catheter (OR, 2.12), mechanical ventilation (OR, 1.56), and prolonged admission (OR, 1.03 for each day).
Risk factors in pediatric trauma patients include ICU admission (OR, 6.25), transfusion of blood products (OR, 2.1), lower extremity fracture (OR, 1.8), and neurosurgery (OR, 2.13). She and her associates hypothesized that understanding the relative contributions of clinical, biological, and genetic risk factors for pediatric VTE would help appropriately risk-stratify patients and allow better prophylactic approaches.
In 2012, Children’s Hospital Colorado implemented a VTE risk assessment tool as part of a hospital-wide patient safety initiative. The assessment is triggered via an Epic Best Practice Advisory to complete in certain higher-risk patients, including ICU patients, hematology/oncology floor patients, any patients with a central line catheter, and those who are over age 12 and obese.
Clinicians also assess for risk factors such as significant infection, recent surgery, and personal or family history of thrombophilia. Next, they classify each patient’s risk of hospital-acquired VTE as high, moderate, or low risk.
In a pilot study, Dr. Southard and her associates set out to validate the accuracy of the institution’s VTE risk assessment tool since it was implemented in 2012. She presented findings from 215 hospital-acquired VTE cases in patients younger than age 18, compared with age-matched inpatient controls. Data from patients under 6 months of age is available after October 2016, coinciding with a change in definition of pediatric hospital-acquired VTE.
Most hospital-acquired VTE patients (77.2%) ranged in age from 1-17 years. The number of patients admitted for a trauma diagnosis was similar between VTE cases and controls (7.4% vs. 7.9%, respectively). However, compared with controls, a significantly greater number of VTE cases were immobile (41.8% vs. 10.3%, respectively), required ICU admission (86.4% vs. 26.5%), had a central venous catheter (80.4% vs. 10.9%), had a positive blood culture (16.7% vs. 1.9%), required surgery or a medical procedure (57.7% vs. 36.7%), and had a longer procedure time (a mean of 151 vs. 133 minutes).
The researchers also found that upon initial admission, 7.9% of VTE cases were identified as high risk and another 21.9% were identified as moderate risk, compared with 1.2% and 3.7% in the controls, respectively.
“Patients identified as moderate or high risk for VTE were generally more medically complex patients,” Dr. Southard said.
Future directions of this project include expanding the patient population that has a risk assessment performed.
Dr. Southard reported having no financial disclosures.
SOURCE: Southard E et al. THSNA 2018.
REPORTING FROM THSNA 2018
Key clinical point:
Major finding: A significantly greater number of VTE patients were immobile (41.8% vs. 10.3%, respectively), required ICU admission (86.4% vs. 26.5%), and had a central venous catheter (80.4% vs. 10.9%), compared with controls.
Study details: A retrospective analysis of 215 hospital-acquired VTE cases in patients younger than age 18.
Disclosures: Dr. Southard reported having no financial disclosures.
Source: Southard E et al. THSNA 2018.
Warfarin dose capping avoided supratherapeutic INRs in hospitalized elderly
SAN DIEGO – A simple intervention of initial warfarin dose capping in hospitalized patients aged 85 years and older led to significant reductions in supratherapeutic INRs without a significant change in length of stay, a single-center study showed.
“We’re excited to see if these results are reproducible,” Jonathan Falsetta, PharmD, said at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “We do feel that it may represent an important step forward in warfarin safety in a vulnerable patient population.”
“From this we gathered that we had an issue with dosing,” said Dr. Falsetta, who is assistant director of pharmacy clinical educational services at Plainview Hospital. “These patients were spiking dangerously high INRs, and we needed to do something about it.”
A review of current medical literature revealed a lack of well-validated recommendations regarding warfarin initiation in older patients, so Dr. Falsetta and his associates set out to create their own dose-capping recommendation. This involved limiting the initial dose of warfarin to 2.5 mg or less for hospitalized patients aged 85 years and older.
“We wanted this to be applicable to patients regardless if they were warfarin naïve or if they had been on warfarin prior to admission,” he said.
Before the roll out, clinical pharmacists and pharmacy residents conducted provider education on the initial dose capping protocol. Providers could order initial doses that exceeded 2.5 mg with valid clinical reasoning. Outcomes of interest were dosing protocol compliance and post-intervention analysis of INRs in this patient population. The pre-intervention period spanned from Nov. 1, 2014 through Oct. 31, 2015, while the post-intervention period spanned from Nov. 1, 2015 through Oct. 31, 2017. Dr. Falsetta reported data from 768 patients.
Between the pre-intervention and post-intervention periods, compliance with dose capping rose from 38.5% to 64.2% (P less than .001), the supratherapeutic INR rate dropped from 20.9% to 13.3% (P= .004), and the length of hospital stay in hours rose from a mean of 145.8 to a mean of 155.8, which was not statistically significant (P= .13).
Following the post-intervention period, the number of peak INRs in the 1 to 2 range rose by 15% and the number of peak INRs in the 2 to 3 range rose by 6%. At the same time, the number of peak INRs in the 3 to 4 range fell by 6%, the number of peak INRs in the 4 to 5 range fell by 36%, and the number of peak INRs in the 5 and greater range fell by 53%. These INR percentages represent relative increases and/or decreases.
“This was a relatively simple intervention that resulted in significant reductions in supratherapeutic INRs,” Dr. Falsetta said.
The researchers also observed that there was less IV vitamin K use after the dose capping intervention. “We can’t say for sure that this was tied to the intervention, but it was interesting, and it is something for us to take a look at, as well as roll this out in future iterations,” he said. “We are on the cusp of rolling this out at some of the tertiary sites within our health care system, and some of the community sites as well.”
He acknowledged certain limitations of the study, including its single-center design, relatively small sample size, and lack of clinical endpoints. “I’d like to be able to tie this to something like reduced bleeding events,” Dr. Falsetta said. “I think that’s something we need to explore in the future.”
Dr. Falsetta reported having no financial disclosures.
SOURCE: Falsetta J et al. THSNA 2018.
SAN DIEGO – A simple intervention of initial warfarin dose capping in hospitalized patients aged 85 years and older led to significant reductions in supratherapeutic INRs without a significant change in length of stay, a single-center study showed.
“We’re excited to see if these results are reproducible,” Jonathan Falsetta, PharmD, said at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “We do feel that it may represent an important step forward in warfarin safety in a vulnerable patient population.”
“From this we gathered that we had an issue with dosing,” said Dr. Falsetta, who is assistant director of pharmacy clinical educational services at Plainview Hospital. “These patients were spiking dangerously high INRs, and we needed to do something about it.”
A review of current medical literature revealed a lack of well-validated recommendations regarding warfarin initiation in older patients, so Dr. Falsetta and his associates set out to create their own dose-capping recommendation. This involved limiting the initial dose of warfarin to 2.5 mg or less for hospitalized patients aged 85 years and older.
“We wanted this to be applicable to patients regardless if they were warfarin naïve or if they had been on warfarin prior to admission,” he said.
Before the roll out, clinical pharmacists and pharmacy residents conducted provider education on the initial dose capping protocol. Providers could order initial doses that exceeded 2.5 mg with valid clinical reasoning. Outcomes of interest were dosing protocol compliance and post-intervention analysis of INRs in this patient population. The pre-intervention period spanned from Nov. 1, 2014 through Oct. 31, 2015, while the post-intervention period spanned from Nov. 1, 2015 through Oct. 31, 2017. Dr. Falsetta reported data from 768 patients.
Between the pre-intervention and post-intervention periods, compliance with dose capping rose from 38.5% to 64.2% (P less than .001), the supratherapeutic INR rate dropped from 20.9% to 13.3% (P= .004), and the length of hospital stay in hours rose from a mean of 145.8 to a mean of 155.8, which was not statistically significant (P= .13).
Following the post-intervention period, the number of peak INRs in the 1 to 2 range rose by 15% and the number of peak INRs in the 2 to 3 range rose by 6%. At the same time, the number of peak INRs in the 3 to 4 range fell by 6%, the number of peak INRs in the 4 to 5 range fell by 36%, and the number of peak INRs in the 5 and greater range fell by 53%. These INR percentages represent relative increases and/or decreases.
“This was a relatively simple intervention that resulted in significant reductions in supratherapeutic INRs,” Dr. Falsetta said.
The researchers also observed that there was less IV vitamin K use after the dose capping intervention. “We can’t say for sure that this was tied to the intervention, but it was interesting, and it is something for us to take a look at, as well as roll this out in future iterations,” he said. “We are on the cusp of rolling this out at some of the tertiary sites within our health care system, and some of the community sites as well.”
He acknowledged certain limitations of the study, including its single-center design, relatively small sample size, and lack of clinical endpoints. “I’d like to be able to tie this to something like reduced bleeding events,” Dr. Falsetta said. “I think that’s something we need to explore in the future.”
Dr. Falsetta reported having no financial disclosures.
SOURCE: Falsetta J et al. THSNA 2018.
SAN DIEGO – A simple intervention of initial warfarin dose capping in hospitalized patients aged 85 years and older led to significant reductions in supratherapeutic INRs without a significant change in length of stay, a single-center study showed.
“We’re excited to see if these results are reproducible,” Jonathan Falsetta, PharmD, said at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “We do feel that it may represent an important step forward in warfarin safety in a vulnerable patient population.”
“From this we gathered that we had an issue with dosing,” said Dr. Falsetta, who is assistant director of pharmacy clinical educational services at Plainview Hospital. “These patients were spiking dangerously high INRs, and we needed to do something about it.”
A review of current medical literature revealed a lack of well-validated recommendations regarding warfarin initiation in older patients, so Dr. Falsetta and his associates set out to create their own dose-capping recommendation. This involved limiting the initial dose of warfarin to 2.5 mg or less for hospitalized patients aged 85 years and older.
“We wanted this to be applicable to patients regardless if they were warfarin naïve or if they had been on warfarin prior to admission,” he said.
Before the roll out, clinical pharmacists and pharmacy residents conducted provider education on the initial dose capping protocol. Providers could order initial doses that exceeded 2.5 mg with valid clinical reasoning. Outcomes of interest were dosing protocol compliance and post-intervention analysis of INRs in this patient population. The pre-intervention period spanned from Nov. 1, 2014 through Oct. 31, 2015, while the post-intervention period spanned from Nov. 1, 2015 through Oct. 31, 2017. Dr. Falsetta reported data from 768 patients.
Between the pre-intervention and post-intervention periods, compliance with dose capping rose from 38.5% to 64.2% (P less than .001), the supratherapeutic INR rate dropped from 20.9% to 13.3% (P= .004), and the length of hospital stay in hours rose from a mean of 145.8 to a mean of 155.8, which was not statistically significant (P= .13).
Following the post-intervention period, the number of peak INRs in the 1 to 2 range rose by 15% and the number of peak INRs in the 2 to 3 range rose by 6%. At the same time, the number of peak INRs in the 3 to 4 range fell by 6%, the number of peak INRs in the 4 to 5 range fell by 36%, and the number of peak INRs in the 5 and greater range fell by 53%. These INR percentages represent relative increases and/or decreases.
“This was a relatively simple intervention that resulted in significant reductions in supratherapeutic INRs,” Dr. Falsetta said.
The researchers also observed that there was less IV vitamin K use after the dose capping intervention. “We can’t say for sure that this was tied to the intervention, but it was interesting, and it is something for us to take a look at, as well as roll this out in future iterations,” he said. “We are on the cusp of rolling this out at some of the tertiary sites within our health care system, and some of the community sites as well.”
He acknowledged certain limitations of the study, including its single-center design, relatively small sample size, and lack of clinical endpoints. “I’d like to be able to tie this to something like reduced bleeding events,” Dr. Falsetta said. “I think that’s something we need to explore in the future.”
Dr. Falsetta reported having no financial disclosures.
SOURCE: Falsetta J et al. THSNA 2018.
REPORTING FROM THSNA 2018
Key clinical point:
Major finding: The supratherapeutic INR rate dropped from 20.9% to 13.3% (P= .004) between the pre- and post-intervention period.
Study details: A single-center study of 768 hospitalized patients aged 85 years and older.
Disclosures: Dr. Falsetta reported having no financial disclosures.
Source: Falsetta J et al., THSNA 2018.
Many VTE patients live in fear of the next event
SAN DIEGO – An estimated 41% of patients who experienced a venous thromboembolism (VTE) fear another clot often or almost all the time. In addition, about 25% report abnormal levels of anxiety, and 12% have abnormal depression scores.
Those are key findings from a large survey that set out to estimate the number of bleeding harms and emotional harms experienced by a U.S. population of adults who have experienced a VTE.
“There is emerging research in Europe that shows high levels of stress and anxiety in people who have a thrombosis event,” lead study author Michael Feehan, PhD, said in an interview at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “We interviewed people around the country and found that a lot of them were living with fear, anxiety, and distress. We did a projective exercise and asked, ‘If VTE was an animal, what would it be?’ Many responded with snakes and bears, hostile things. Snakes came up a lot. Snakes can be dormant, and then they can suddenly come out and bite you. That was the kind of language they were using.”
In what he said is the largest study of its kind, Dr. Feehan, a psychologist in the College of Pharmacy at the University of Utah, Salt Lake City, and his associates conducted an online survey of 907 patients aged 18 and older who had experienced a VTE event in the previous 24 months.
The survey was administered in May 2016 and excluded patients with cancer-related VTE. It took about 30 minutes to complete and included questions about the bleeding harms that have occurred since their VTE diagnosis, such as nosebleeds or a cut difficult to control, excessive bruising, vomiting blood, bloody urine, and blood in stools. It also included standardized measures of anxiety, depression, cognitive function, and ratings on eight items of current distress, feeling tense, anxious, confused, depressed, afraid, angry, frustrated, or annoyed.
Self-reported bleeding events included excessive bruising (45%), bleeding from cuts difficult to control (33%), and epistaxis (16%). As for emotional harm, 41% of respondents lived in fear of getting another clot “often” or “almost all the time,” while 25% experienced abnormally high levels of anxiety, and 12% experienced abnormally high levels of depression.
A multivariate structural equation model revealed the following principal factors significantly associated with a composite latent variable of emotional harm: poor health literacy, younger age, the lack of perceived self-control over one’s health, history of medical mistakes in care, and overt barriers to health care access such as transportation limitations and financial limitations (P less than .05 for all associations).
“If you’re working with patients who believe they don’t have any control over their own care, or if they’re younger or have other disease states, or if they have difficulty getting to and from the hospital, all of those things contribute to elevated emotional harms,” Dr. Feehan said. “That level of emotional harm is clinically relevant.”
After the research team shared the study results with staff of the university’s thrombosis services, clinicians started changing how they interview patients. “For example, instead of asking just ‘Have you experienced any VTE symptoms?’ they now ask things like, ‘How are you feeling?’ or ‘How are things going for you living with the disease?’” Dr. Feehan noted. “Then, patients might say, ‘I’m actually quite worried.’ Such questions can help patients open up about how they feel and foster a better relationship with their provider. A better relationship with their provider might help them feel more in control.”
The study was supported by Pfizer Independent Grants for Learning & Change, Bristol-Myers Squibb Independent Medical Education, the Joint Commission, the National Eye Institute, and an unrestricted grant from Research to Prevent Blindness. Dr. Feehan disclosed that he has consulted for Pfizer in the past.
SOURCE: Feehan et al. THSNA 2018, Poster 75.
SAN DIEGO – An estimated 41% of patients who experienced a venous thromboembolism (VTE) fear another clot often or almost all the time. In addition, about 25% report abnormal levels of anxiety, and 12% have abnormal depression scores.
Those are key findings from a large survey that set out to estimate the number of bleeding harms and emotional harms experienced by a U.S. population of adults who have experienced a VTE.
“There is emerging research in Europe that shows high levels of stress and anxiety in people who have a thrombosis event,” lead study author Michael Feehan, PhD, said in an interview at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “We interviewed people around the country and found that a lot of them were living with fear, anxiety, and distress. We did a projective exercise and asked, ‘If VTE was an animal, what would it be?’ Many responded with snakes and bears, hostile things. Snakes came up a lot. Snakes can be dormant, and then they can suddenly come out and bite you. That was the kind of language they were using.”
In what he said is the largest study of its kind, Dr. Feehan, a psychologist in the College of Pharmacy at the University of Utah, Salt Lake City, and his associates conducted an online survey of 907 patients aged 18 and older who had experienced a VTE event in the previous 24 months.
The survey was administered in May 2016 and excluded patients with cancer-related VTE. It took about 30 minutes to complete and included questions about the bleeding harms that have occurred since their VTE diagnosis, such as nosebleeds or a cut difficult to control, excessive bruising, vomiting blood, bloody urine, and blood in stools. It also included standardized measures of anxiety, depression, cognitive function, and ratings on eight items of current distress, feeling tense, anxious, confused, depressed, afraid, angry, frustrated, or annoyed.
Self-reported bleeding events included excessive bruising (45%), bleeding from cuts difficult to control (33%), and epistaxis (16%). As for emotional harm, 41% of respondents lived in fear of getting another clot “often” or “almost all the time,” while 25% experienced abnormally high levels of anxiety, and 12% experienced abnormally high levels of depression.
A multivariate structural equation model revealed the following principal factors significantly associated with a composite latent variable of emotional harm: poor health literacy, younger age, the lack of perceived self-control over one’s health, history of medical mistakes in care, and overt barriers to health care access such as transportation limitations and financial limitations (P less than .05 for all associations).
“If you’re working with patients who believe they don’t have any control over their own care, or if they’re younger or have other disease states, or if they have difficulty getting to and from the hospital, all of those things contribute to elevated emotional harms,” Dr. Feehan said. “That level of emotional harm is clinically relevant.”
After the research team shared the study results with staff of the university’s thrombosis services, clinicians started changing how they interview patients. “For example, instead of asking just ‘Have you experienced any VTE symptoms?’ they now ask things like, ‘How are you feeling?’ or ‘How are things going for you living with the disease?’” Dr. Feehan noted. “Then, patients might say, ‘I’m actually quite worried.’ Such questions can help patients open up about how they feel and foster a better relationship with their provider. A better relationship with their provider might help them feel more in control.”
The study was supported by Pfizer Independent Grants for Learning & Change, Bristol-Myers Squibb Independent Medical Education, the Joint Commission, the National Eye Institute, and an unrestricted grant from Research to Prevent Blindness. Dr. Feehan disclosed that he has consulted for Pfizer in the past.
SOURCE: Feehan et al. THSNA 2018, Poster 75.
SAN DIEGO – An estimated 41% of patients who experienced a venous thromboembolism (VTE) fear another clot often or almost all the time. In addition, about 25% report abnormal levels of anxiety, and 12% have abnormal depression scores.
Those are key findings from a large survey that set out to estimate the number of bleeding harms and emotional harms experienced by a U.S. population of adults who have experienced a VTE.
“There is emerging research in Europe that shows high levels of stress and anxiety in people who have a thrombosis event,” lead study author Michael Feehan, PhD, said in an interview at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “We interviewed people around the country and found that a lot of them were living with fear, anxiety, and distress. We did a projective exercise and asked, ‘If VTE was an animal, what would it be?’ Many responded with snakes and bears, hostile things. Snakes came up a lot. Snakes can be dormant, and then they can suddenly come out and bite you. That was the kind of language they were using.”
In what he said is the largest study of its kind, Dr. Feehan, a psychologist in the College of Pharmacy at the University of Utah, Salt Lake City, and his associates conducted an online survey of 907 patients aged 18 and older who had experienced a VTE event in the previous 24 months.
The survey was administered in May 2016 and excluded patients with cancer-related VTE. It took about 30 minutes to complete and included questions about the bleeding harms that have occurred since their VTE diagnosis, such as nosebleeds or a cut difficult to control, excessive bruising, vomiting blood, bloody urine, and blood in stools. It also included standardized measures of anxiety, depression, cognitive function, and ratings on eight items of current distress, feeling tense, anxious, confused, depressed, afraid, angry, frustrated, or annoyed.
Self-reported bleeding events included excessive bruising (45%), bleeding from cuts difficult to control (33%), and epistaxis (16%). As for emotional harm, 41% of respondents lived in fear of getting another clot “often” or “almost all the time,” while 25% experienced abnormally high levels of anxiety, and 12% experienced abnormally high levels of depression.
A multivariate structural equation model revealed the following principal factors significantly associated with a composite latent variable of emotional harm: poor health literacy, younger age, the lack of perceived self-control over one’s health, history of medical mistakes in care, and overt barriers to health care access such as transportation limitations and financial limitations (P less than .05 for all associations).
“If you’re working with patients who believe they don’t have any control over their own care, or if they’re younger or have other disease states, or if they have difficulty getting to and from the hospital, all of those things contribute to elevated emotional harms,” Dr. Feehan said. “That level of emotional harm is clinically relevant.”
After the research team shared the study results with staff of the university’s thrombosis services, clinicians started changing how they interview patients. “For example, instead of asking just ‘Have you experienced any VTE symptoms?’ they now ask things like, ‘How are you feeling?’ or ‘How are things going for you living with the disease?’” Dr. Feehan noted. “Then, patients might say, ‘I’m actually quite worried.’ Such questions can help patients open up about how they feel and foster a better relationship with their provider. A better relationship with their provider might help them feel more in control.”
The study was supported by Pfizer Independent Grants for Learning & Change, Bristol-Myers Squibb Independent Medical Education, the Joint Commission, the National Eye Institute, and an unrestricted grant from Research to Prevent Blindness. Dr. Feehan disclosed that he has consulted for Pfizer in the past.
SOURCE: Feehan et al. THSNA 2018, Poster 75.
REPORTING FROM THSNA 2018
Key clinical point: Consider asking VTE patients how living with their disease affects them from an emotional standpoint.
Major finding: Of 907 survey respondents, 41% said they live in fear of getting another clot “often” or “almost all the time.”
Study details: An online survey of 907 patients aged 18 and older who had experienced a VTE event in the previous 24 months.
Disclosures: The study was supported by Pfizer Independent Grants for Learning & Change, Bristol-Myers Squibb Independent Medical Education, the Joint Commission, the National Eye Institute, and an unrestricted grant from Research to Prevent Blindness. Dr. Feehan disclosed that he has consulted for Pfizer in the past.
Source: Feehan M et al. THSNA 2018, Poster 75.
Bleeding episodes more common in boys with VWD
SAN DIEGO – Among children with types 1 and 2 von Willebrand disease (VWD), a higher proportion of boys than girls reported ever having a bleeding episode and using more treatment products. But the trend did not continue among children with type 3 disease.
Those are some of the key findings from a never-before-published analysis of surveillance data from the Centers for Disease Control and Prevention presented by Karon Abe, PhD, during a poster session at the biennial summit of the Thrombosis & Hemostasis Societies of North America.
The researchers retrieved data from the UDC (Universal Data Collection System), a federally funded surveillance system of people with hemophilia and other bleeding disorders treated at 130 U.S. Hemophilia Treatment Centers (HTCs) during 1998-2011. Although UDC data collection ended in 2011, a current CDC bleeding surveillance project called Community Counts continues and expands on the work of the UDC.
Between 1998 and 2011, data were collected on 2,413 children with VWD aged 2-12 years. Of these, 2,070 had type 1, 224 had type 2, and 119 had type 3 VWD. The researchers used chi-square analysis and Wilcoxon rank sum tests to assess differences in bleeding characteristics by sex and by type of VWD. Next, they used a multivariate regression model to examine the association between demographic and clinical characteristics and a history of ever having had a bleeding episode among type 1 VWD patients.
Nearly two-thirds of children (65%) were non-Hispanic, 17% were Hispanic, 8% were black, and the remainder were from other ethnicities. In addition, 40% of the children had no family history of a bleeding disorder.
The median age of first bleed was lower among children with type 3 VWD, compared with other VWD types, and was lower among boys than girls with type 1 VWD (36 months vs. 48 months, respectively; P less than .001) and type 3 VWD (9 months vs. 12 months; P = .04), Dr. Abe reported.
A higher proportion of boys than girls reported ever having a bleeding episode among children with type 1 VWD (78% vs. 73%; P = .01) and type 2 VWD (90% vs. 75%; P = .01), but not among children with type 3 VWD (97% vs. 96%; P = .77).
A higher prevalence of treatment-product use was reported among children with type 3 VWD, compared with those with the other VWD types (a mean of 95% vs. 79% and 71% among types 2 and 1, respectively). A significantly higher prevalence of the use of treatment product was seen among boys than girls with type 1 VWD (73% vs. 68%, P = .03) and type 2 VWD (87% vs. 72%, P =.01), but not type 3 VWD (94% vs. 96%, P = .87).
The most common sites of the first bleed among all patients regardless of gender or VWD type were epistaxis and oral cavity bleeding.
“To our surprise, the boys were showing more bleeding and were receiving more product than the females,” Dr. Abe said in an interview. “This is a fairly large population.”
Multivariate regression analysis revealed independent associations between the following patient characteristics and ever having a bleed among children with type 1 VWD: male gender (adjusted odds ratio, 1.23); being aged 7-9 years at registration, compared with being aged 2-6 years (aOR, 1.5); being black (aOR, 1.7); being Asian, Native Hawaiian or Pacific Islander (aOR, 2.4), being Hispanic (aOR, 2.8), and being some other race/ethnicity (aOR, 1.8). However, family history of a bleeding disorder was protective (aOR, 0.721).
Dr. Abe said she hopes that the findings will raise awareness and help physicians to educate families about bleeding symptoms and intervene to treat bleeding episodes appropriately. She and her associates are planning to compare the data with Community Counts, “so it’s more up to date,” she said.
Dr. Abe reported having no financial disclosures.
SOURCE: Abe K et al. THSNA 2018, Poster 145.
SAN DIEGO – Among children with types 1 and 2 von Willebrand disease (VWD), a higher proportion of boys than girls reported ever having a bleeding episode and using more treatment products. But the trend did not continue among children with type 3 disease.
Those are some of the key findings from a never-before-published analysis of surveillance data from the Centers for Disease Control and Prevention presented by Karon Abe, PhD, during a poster session at the biennial summit of the Thrombosis & Hemostasis Societies of North America.
The researchers retrieved data from the UDC (Universal Data Collection System), a federally funded surveillance system of people with hemophilia and other bleeding disorders treated at 130 U.S. Hemophilia Treatment Centers (HTCs) during 1998-2011. Although UDC data collection ended in 2011, a current CDC bleeding surveillance project called Community Counts continues and expands on the work of the UDC.
Between 1998 and 2011, data were collected on 2,413 children with VWD aged 2-12 years. Of these, 2,070 had type 1, 224 had type 2, and 119 had type 3 VWD. The researchers used chi-square analysis and Wilcoxon rank sum tests to assess differences in bleeding characteristics by sex and by type of VWD. Next, they used a multivariate regression model to examine the association between demographic and clinical characteristics and a history of ever having had a bleeding episode among type 1 VWD patients.
Nearly two-thirds of children (65%) were non-Hispanic, 17% were Hispanic, 8% were black, and the remainder were from other ethnicities. In addition, 40% of the children had no family history of a bleeding disorder.
The median age of first bleed was lower among children with type 3 VWD, compared with other VWD types, and was lower among boys than girls with type 1 VWD (36 months vs. 48 months, respectively; P less than .001) and type 3 VWD (9 months vs. 12 months; P = .04), Dr. Abe reported.
A higher proportion of boys than girls reported ever having a bleeding episode among children with type 1 VWD (78% vs. 73%; P = .01) and type 2 VWD (90% vs. 75%; P = .01), but not among children with type 3 VWD (97% vs. 96%; P = .77).
A higher prevalence of treatment-product use was reported among children with type 3 VWD, compared with those with the other VWD types (a mean of 95% vs. 79% and 71% among types 2 and 1, respectively). A significantly higher prevalence of the use of treatment product was seen among boys than girls with type 1 VWD (73% vs. 68%, P = .03) and type 2 VWD (87% vs. 72%, P =.01), but not type 3 VWD (94% vs. 96%, P = .87).
The most common sites of the first bleed among all patients regardless of gender or VWD type were epistaxis and oral cavity bleeding.
“To our surprise, the boys were showing more bleeding and were receiving more product than the females,” Dr. Abe said in an interview. “This is a fairly large population.”
Multivariate regression analysis revealed independent associations between the following patient characteristics and ever having a bleed among children with type 1 VWD: male gender (adjusted odds ratio, 1.23); being aged 7-9 years at registration, compared with being aged 2-6 years (aOR, 1.5); being black (aOR, 1.7); being Asian, Native Hawaiian or Pacific Islander (aOR, 2.4), being Hispanic (aOR, 2.8), and being some other race/ethnicity (aOR, 1.8). However, family history of a bleeding disorder was protective (aOR, 0.721).
Dr. Abe said she hopes that the findings will raise awareness and help physicians to educate families about bleeding symptoms and intervene to treat bleeding episodes appropriately. She and her associates are planning to compare the data with Community Counts, “so it’s more up to date,” she said.
Dr. Abe reported having no financial disclosures.
SOURCE: Abe K et al. THSNA 2018, Poster 145.
SAN DIEGO – Among children with types 1 and 2 von Willebrand disease (VWD), a higher proportion of boys than girls reported ever having a bleeding episode and using more treatment products. But the trend did not continue among children with type 3 disease.
Those are some of the key findings from a never-before-published analysis of surveillance data from the Centers for Disease Control and Prevention presented by Karon Abe, PhD, during a poster session at the biennial summit of the Thrombosis & Hemostasis Societies of North America.
The researchers retrieved data from the UDC (Universal Data Collection System), a federally funded surveillance system of people with hemophilia and other bleeding disorders treated at 130 U.S. Hemophilia Treatment Centers (HTCs) during 1998-2011. Although UDC data collection ended in 2011, a current CDC bleeding surveillance project called Community Counts continues and expands on the work of the UDC.
Between 1998 and 2011, data were collected on 2,413 children with VWD aged 2-12 years. Of these, 2,070 had type 1, 224 had type 2, and 119 had type 3 VWD. The researchers used chi-square analysis and Wilcoxon rank sum tests to assess differences in bleeding characteristics by sex and by type of VWD. Next, they used a multivariate regression model to examine the association between demographic and clinical characteristics and a history of ever having had a bleeding episode among type 1 VWD patients.
Nearly two-thirds of children (65%) were non-Hispanic, 17% were Hispanic, 8% were black, and the remainder were from other ethnicities. In addition, 40% of the children had no family history of a bleeding disorder.
The median age of first bleed was lower among children with type 3 VWD, compared with other VWD types, and was lower among boys than girls with type 1 VWD (36 months vs. 48 months, respectively; P less than .001) and type 3 VWD (9 months vs. 12 months; P = .04), Dr. Abe reported.
A higher proportion of boys than girls reported ever having a bleeding episode among children with type 1 VWD (78% vs. 73%; P = .01) and type 2 VWD (90% vs. 75%; P = .01), but not among children with type 3 VWD (97% vs. 96%; P = .77).
A higher prevalence of treatment-product use was reported among children with type 3 VWD, compared with those with the other VWD types (a mean of 95% vs. 79% and 71% among types 2 and 1, respectively). A significantly higher prevalence of the use of treatment product was seen among boys than girls with type 1 VWD (73% vs. 68%, P = .03) and type 2 VWD (87% vs. 72%, P =.01), but not type 3 VWD (94% vs. 96%, P = .87).
The most common sites of the first bleed among all patients regardless of gender or VWD type were epistaxis and oral cavity bleeding.
“To our surprise, the boys were showing more bleeding and were receiving more product than the females,” Dr. Abe said in an interview. “This is a fairly large population.”
Multivariate regression analysis revealed independent associations between the following patient characteristics and ever having a bleed among children with type 1 VWD: male gender (adjusted odds ratio, 1.23); being aged 7-9 years at registration, compared with being aged 2-6 years (aOR, 1.5); being black (aOR, 1.7); being Asian, Native Hawaiian or Pacific Islander (aOR, 2.4), being Hispanic (aOR, 2.8), and being some other race/ethnicity (aOR, 1.8). However, family history of a bleeding disorder was protective (aOR, 0.721).
Dr. Abe said she hopes that the findings will raise awareness and help physicians to educate families about bleeding symptoms and intervene to treat bleeding episodes appropriately. She and her associates are planning to compare the data with Community Counts, “so it’s more up to date,” she said.
Dr. Abe reported having no financial disclosures.
SOURCE: Abe K et al. THSNA 2018, Poster 145.
REPORTING FROM THSNA 2018
Key clinical point:
Major finding: A higher proportion of boys than girls reported ever having a bleeding episode among children with type 1 VWD (78% vs. 73%; P= .01) and type 2 VWD (90% vs. 75%; P= .01), but not among children with type 3 VWD (97% vs. 96%; P= .77).
Study details: An analysis of 2,413 children with VWD aged 2-12 years.
Disclosures: Dr. Abe reported having no financial disclosures.
Source: Abe K et al. THSNA 2018, Poster 145.
Beware of polypharmacy in patients taking warfarin
SAN DIEGO – The incidence of polypharmacy among patients on warfarin therapy appears to peak at age 75, with close to 10 concurrent active prescriptions on average, results from a single-center study showed.
“Beware of polypharmacy with these patients,” Alan Jacobson, MD, said in an interview at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “Anticoagulation tends to be a high-risk area. If you don’t treat, people have strokes. If you treat, they can have bleeds. Warfarin is the number one drug that gets older patients into the ER and admitted. We know that warfarin has a lot of drug-drug interactions.”
For example, in the ARISTOTLE trial, patients used a median of six drugs, and 26% of patients used nine or more drugs (BMJ. 2016 Jun 15;353:i2868.
In an effort to determine the average and maximum number of concurrent prescription drugs for age-dependent brackets of patients on warfarin, Dr. Jacobson and his associates reviewed the electronic pharmacy records of 1,122 warfarin patients at the VA Loma Linda Healthcare System. They excluded medications that could be obtained over the counter and calculated the average number of concurrent drugs for each of 10 age brackets: under age 50, over age 90, and eight brackets between those limits.
The researchers reported that 9,885 prescriptions were tabulated for the study population, which translated into a per patient average of 8.8 concurrent active prescription drugs, independent of age. They observed an age-dependent increase in the number of concurrent drugs that peaked at 9.9 among patients aged 70-74 years, and tapered off in those older than age 75. One patient in the 70- to 74-year-old age group was on 28 active prescriptions.
“If you’re on 28 pills, your chance of a bleeding complication is high,” Dr. Jacobson said. “We try to be rigorous with all of our patients on education. With these patients, slow the conversation down more. Have a family member come in with them and go into more detail.”
He added that the maximum number of concurrent prescriptions for any single patient in each age bracket tended to be two to three times higher than that of the average patient.
Dr. Jacobson acknowledged certain limitations of the study, including its single-center design and relatively small sample size. There was also no comparison available as to the number of concurrent prescriptions for patients not receiving warfarin. He reported having no financial disclosures.
dbrunk@mdedge.com
SOURCE: Jacobson M et al. THSNA 2018. Poster 2.
SAN DIEGO – The incidence of polypharmacy among patients on warfarin therapy appears to peak at age 75, with close to 10 concurrent active prescriptions on average, results from a single-center study showed.
“Beware of polypharmacy with these patients,” Alan Jacobson, MD, said in an interview at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “Anticoagulation tends to be a high-risk area. If you don’t treat, people have strokes. If you treat, they can have bleeds. Warfarin is the number one drug that gets older patients into the ER and admitted. We know that warfarin has a lot of drug-drug interactions.”
For example, in the ARISTOTLE trial, patients used a median of six drugs, and 26% of patients used nine or more drugs (BMJ. 2016 Jun 15;353:i2868.
In an effort to determine the average and maximum number of concurrent prescription drugs for age-dependent brackets of patients on warfarin, Dr. Jacobson and his associates reviewed the electronic pharmacy records of 1,122 warfarin patients at the VA Loma Linda Healthcare System. They excluded medications that could be obtained over the counter and calculated the average number of concurrent drugs for each of 10 age brackets: under age 50, over age 90, and eight brackets between those limits.
The researchers reported that 9,885 prescriptions were tabulated for the study population, which translated into a per patient average of 8.8 concurrent active prescription drugs, independent of age. They observed an age-dependent increase in the number of concurrent drugs that peaked at 9.9 among patients aged 70-74 years, and tapered off in those older than age 75. One patient in the 70- to 74-year-old age group was on 28 active prescriptions.
“If you’re on 28 pills, your chance of a bleeding complication is high,” Dr. Jacobson said. “We try to be rigorous with all of our patients on education. With these patients, slow the conversation down more. Have a family member come in with them and go into more detail.”
He added that the maximum number of concurrent prescriptions for any single patient in each age bracket tended to be two to three times higher than that of the average patient.
Dr. Jacobson acknowledged certain limitations of the study, including its single-center design and relatively small sample size. There was also no comparison available as to the number of concurrent prescriptions for patients not receiving warfarin. He reported having no financial disclosures.
dbrunk@mdedge.com
SOURCE: Jacobson M et al. THSNA 2018. Poster 2.
SAN DIEGO – The incidence of polypharmacy among patients on warfarin therapy appears to peak at age 75, with close to 10 concurrent active prescriptions on average, results from a single-center study showed.
“Beware of polypharmacy with these patients,” Alan Jacobson, MD, said in an interview at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “Anticoagulation tends to be a high-risk area. If you don’t treat, people have strokes. If you treat, they can have bleeds. Warfarin is the number one drug that gets older patients into the ER and admitted. We know that warfarin has a lot of drug-drug interactions.”
For example, in the ARISTOTLE trial, patients used a median of six drugs, and 26% of patients used nine or more drugs (BMJ. 2016 Jun 15;353:i2868.
In an effort to determine the average and maximum number of concurrent prescription drugs for age-dependent brackets of patients on warfarin, Dr. Jacobson and his associates reviewed the electronic pharmacy records of 1,122 warfarin patients at the VA Loma Linda Healthcare System. They excluded medications that could be obtained over the counter and calculated the average number of concurrent drugs for each of 10 age brackets: under age 50, over age 90, and eight brackets between those limits.
The researchers reported that 9,885 prescriptions were tabulated for the study population, which translated into a per patient average of 8.8 concurrent active prescription drugs, independent of age. They observed an age-dependent increase in the number of concurrent drugs that peaked at 9.9 among patients aged 70-74 years, and tapered off in those older than age 75. One patient in the 70- to 74-year-old age group was on 28 active prescriptions.
“If you’re on 28 pills, your chance of a bleeding complication is high,” Dr. Jacobson said. “We try to be rigorous with all of our patients on education. With these patients, slow the conversation down more. Have a family member come in with them and go into more detail.”
He added that the maximum number of concurrent prescriptions for any single patient in each age bracket tended to be two to three times higher than that of the average patient.
Dr. Jacobson acknowledged certain limitations of the study, including its single-center design and relatively small sample size. There was also no comparison available as to the number of concurrent prescriptions for patients not receiving warfarin. He reported having no financial disclosures.
dbrunk@mdedge.com
SOURCE: Jacobson M et al. THSNA 2018. Poster 2.
REPORTING FROM THSNA 2018
Key clinical point:
Major finding: On average, warfarin patients had 8.8 concurrent active prescription drugs.
Study details: A review of medical records from 1,122 warfarin patients.
Disclosures: Dr. Jacobson reported having no financial disclosures.
Source: Jacobson A et al. THSNA 2018. Poster 2.
DOACs may be beneficial in post-op atrial fib after CABG
SAN DIEGO – The use of direct oral anticoagulants were not significantly different from warfarin for safety and efficacy in cases of postoperative atrial fibrillation following coronary artery bypass grafting, according to results from a single-center study.
In fact, , which suggests a potential for reduced hospital stay-related costs. “There are several different niche populations for which the DOACs have not been studied,” one of the study authors, Ammie J. Patel, PharmD, said in an interview at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “This provides the opportunity for institutions and hospitals to study the use of these drugs in non-traditional ways.”
Dr. Patel, of Temple University, Philadelphia, said that postoperative atrial fibrillation occurs in about 30% of patients following CABG and that new-onset postoperative atrial fibrillation after CABG has been linked to a 21% increase in relative mortality.
Noting that patients with planned major surgery were excluded from RE-LY, ROCKET AF, ARISTOTLE, and other pivotal clinical trials of DOACs, she and her research mentor, Rachael Durie, PharmD, retrospectively evaluated the safety and efficacy of DOACs in 285 cases of new-onset postoperative atrial fibrillation following CABG performed at Jersey Shore University Medical Center, Neptune, N.J., between July 1, 2014, and June 30, 2016. They hypothesized that using DOACs in this patient population might offer advantages over warfarin, including rapid onset and earlier hospital discharge, fewer drug interactions, and no coagulation monitoring.
Of the 146 patients on anticoagulants, 79 were discharged on warfarin, 43 on apixaban, 20 on rivaroxaban, and 4 on dabigatran. The other 139 patients were not anticoagulated for various reasons, one of which included normal sinus rhythm at discharge.
The researchers found that the DOACs were not significantly different from warfarin for efficacy endpoints in stroke (P = 0.23) or systemic embolism (P = 0.68). Safety endpoints also were similar among all groups for major bleeding (P = 0.57) or minor bleeding (P = 0.63). Median post-CABG length of stay was significantly longer in the warfarin group (8 days, P = 0.005), compared with dabigatran (7.5 days), rivaroxaban (6.5 days), and apixaban (6 days). In addition, the median total hospital length of stay was significantly longer with warfarin (11 days, P = 0.004), compared with rivaroxaban (8.5 days) and apixaban (9 days), but not compared with dabigatran (12 days).
Dr. Patel acknowledged that the study’s retrospective design and small sample size are limitations and said that larger prospective trials are warranted to confirm these results. She reported having no financial disclosures.
dbrunk@frontlinemedcom.com
SOURCE: Patel AJ et al. THSNA 2018. Poster 64.
SAN DIEGO – The use of direct oral anticoagulants were not significantly different from warfarin for safety and efficacy in cases of postoperative atrial fibrillation following coronary artery bypass grafting, according to results from a single-center study.
In fact, , which suggests a potential for reduced hospital stay-related costs. “There are several different niche populations for which the DOACs have not been studied,” one of the study authors, Ammie J. Patel, PharmD, said in an interview at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “This provides the opportunity for institutions and hospitals to study the use of these drugs in non-traditional ways.”
Dr. Patel, of Temple University, Philadelphia, said that postoperative atrial fibrillation occurs in about 30% of patients following CABG and that new-onset postoperative atrial fibrillation after CABG has been linked to a 21% increase in relative mortality.
Noting that patients with planned major surgery were excluded from RE-LY, ROCKET AF, ARISTOTLE, and other pivotal clinical trials of DOACs, she and her research mentor, Rachael Durie, PharmD, retrospectively evaluated the safety and efficacy of DOACs in 285 cases of new-onset postoperative atrial fibrillation following CABG performed at Jersey Shore University Medical Center, Neptune, N.J., between July 1, 2014, and June 30, 2016. They hypothesized that using DOACs in this patient population might offer advantages over warfarin, including rapid onset and earlier hospital discharge, fewer drug interactions, and no coagulation monitoring.
Of the 146 patients on anticoagulants, 79 were discharged on warfarin, 43 on apixaban, 20 on rivaroxaban, and 4 on dabigatran. The other 139 patients were not anticoagulated for various reasons, one of which included normal sinus rhythm at discharge.
The researchers found that the DOACs were not significantly different from warfarin for efficacy endpoints in stroke (P = 0.23) or systemic embolism (P = 0.68). Safety endpoints also were similar among all groups for major bleeding (P = 0.57) or minor bleeding (P = 0.63). Median post-CABG length of stay was significantly longer in the warfarin group (8 days, P = 0.005), compared with dabigatran (7.5 days), rivaroxaban (6.5 days), and apixaban (6 days). In addition, the median total hospital length of stay was significantly longer with warfarin (11 days, P = 0.004), compared with rivaroxaban (8.5 days) and apixaban (9 days), but not compared with dabigatran (12 days).
Dr. Patel acknowledged that the study’s retrospective design and small sample size are limitations and said that larger prospective trials are warranted to confirm these results. She reported having no financial disclosures.
dbrunk@frontlinemedcom.com
SOURCE: Patel AJ et al. THSNA 2018. Poster 64.
SAN DIEGO – The use of direct oral anticoagulants were not significantly different from warfarin for safety and efficacy in cases of postoperative atrial fibrillation following coronary artery bypass grafting, according to results from a single-center study.
In fact, , which suggests a potential for reduced hospital stay-related costs. “There are several different niche populations for which the DOACs have not been studied,” one of the study authors, Ammie J. Patel, PharmD, said in an interview at the biennial summit of the Thrombosis & Hemostasis Societies of North America. “This provides the opportunity for institutions and hospitals to study the use of these drugs in non-traditional ways.”
Dr. Patel, of Temple University, Philadelphia, said that postoperative atrial fibrillation occurs in about 30% of patients following CABG and that new-onset postoperative atrial fibrillation after CABG has been linked to a 21% increase in relative mortality.
Noting that patients with planned major surgery were excluded from RE-LY, ROCKET AF, ARISTOTLE, and other pivotal clinical trials of DOACs, she and her research mentor, Rachael Durie, PharmD, retrospectively evaluated the safety and efficacy of DOACs in 285 cases of new-onset postoperative atrial fibrillation following CABG performed at Jersey Shore University Medical Center, Neptune, N.J., between July 1, 2014, and June 30, 2016. They hypothesized that using DOACs in this patient population might offer advantages over warfarin, including rapid onset and earlier hospital discharge, fewer drug interactions, and no coagulation monitoring.
Of the 146 patients on anticoagulants, 79 were discharged on warfarin, 43 on apixaban, 20 on rivaroxaban, and 4 on dabigatran. The other 139 patients were not anticoagulated for various reasons, one of which included normal sinus rhythm at discharge.
The researchers found that the DOACs were not significantly different from warfarin for efficacy endpoints in stroke (P = 0.23) or systemic embolism (P = 0.68). Safety endpoints also were similar among all groups for major bleeding (P = 0.57) or minor bleeding (P = 0.63). Median post-CABG length of stay was significantly longer in the warfarin group (8 days, P = 0.005), compared with dabigatran (7.5 days), rivaroxaban (6.5 days), and apixaban (6 days). In addition, the median total hospital length of stay was significantly longer with warfarin (11 days, P = 0.004), compared with rivaroxaban (8.5 days) and apixaban (9 days), but not compared with dabigatran (12 days).
Dr. Patel acknowledged that the study’s retrospective design and small sample size are limitations and said that larger prospective trials are warranted to confirm these results. She reported having no financial disclosures.
dbrunk@frontlinemedcom.com
SOURCE: Patel AJ et al. THSNA 2018. Poster 64.
REPORTING FROM THSNA 2018
Key clinical point: DOACs may be safe and effective alternatives to warfarin in postoperative atrial fibrillation after CABG.
Major finding: DOACs were not significantly different from warfarin for efficacy endpoints in stroke (P = 0.23) or systemic embolism (P = 0.68).
Study details: A retrospective, single-center study of DOACs in 285 cases of new-onset postoperative atrial fibrillation following CABG.
Disclosures: Dr. Patel reported having no financial disclosures.
Source: Patel AJ et al. THSNA 2018. Poster 64.
Low vitamin D common in chronically anticoagulated children
SAN DIEGO – Pediatric hematologists should consider testing for vitamin D deficiency to optimize bone health in children who will be receiving chronic anticoagulation. That’s a key message from a single-center retrospective review presented during a poster session at the biennial summit of the Thrombosis & Hemostasis Societies of North America.
“More research is needed to determine which children should be targeted for screening for low [bone mineral density], though our research suggests that children with prolonged treatment with steroids may be at the highest risk,” Kavita N. Patel, MD, one of the study’s authors, said in an interview.
“A few studies have shown reduced BMD in children taking warfarin,” she said. “Subsequently, recommendations have been published that children receiving chronic anticoagulation undergo bone density testing. This study sought to determine if children who were receiving chronic anticoagulation [not only warfarin but also low molecular weight heparins and direct oral anticoagulants] had low BMD and whether the length of anticoagulation or any other medical conditions or medications affected the probability of having low BMD. We also wanted to report on the prevalence of low vitamin D in this same group of children since low vitamin D is a known risk for low BMD.”
The study population was a retrospective cohort of children aged 10-21 years who received anticoagulation for more than 1 year at Children’s Healthcare of Atlanta between Jan. 2, 2012, and Oct. 15, 2017. The researchers evaluated a number of factors, including demographic variables, anticoagulants used, vitamin D status, previously reported comorbid conditions and medications associated with changes in BMD. They defined vitamin D deficiency as less than 20 ng/mL and insufficiency as 20-29 ng/mL.
Dr. Patel reported results from 27 males and 23 females. Of these, 15 (30%) underwent bone density testing with dual-energy X-ray absorptiometry; 5 (10%) did not undergo dual-energy X-ray absorptiometry testing because there is no age-specific standardization below the age of 5 years. Nearly half of the patients (42%) were Caucasian, 34% were African American, 16% were Hispanic, and the rest were from other ethnicities. The top four common indications for extended anticoagulation were recurrent venous thromboembolism (26%), extended treatment for deep vein thrombosis (18%), antiphospholipid syndrome (14%), and thrombophilia plus a single venous thromboembolism (14%).
The anticoagulants most often utilized were enoxaparin (59%), warfarin (29%), and rivaroxaban (7%). The most frequent risk factor for low BMD was long-term use of steroids (16%; defined as greater than 6 months of continuous use in the year prior to BMD testing).
Vitamin D deficiency was identified in 52% of subjects who were tested, while another 24% had insufficient levels of vitamin D. Overall, the median lumbar spine z score was –1.4. Five (30%) subjects who completed BMD testing had low BMD, with median z score of –2.5. None met fracture criteria for pediatric osteoporosis. On linear regression, the only factor found to be significantly associated with a BMD lumbar spine z score in chronically anticoagulated children was the long-term use of steroids (P = .04).
Dr. Patel acknowledged certain limitations of the study, including its single-center design and the fact that not all of the children receiving chronic anticoagulation could be tested.
She reported having no financial disclosures.
SOURCE: Patel KN et al. THSNA 2018, Poster 65.
SAN DIEGO – Pediatric hematologists should consider testing for vitamin D deficiency to optimize bone health in children who will be receiving chronic anticoagulation. That’s a key message from a single-center retrospective review presented during a poster session at the biennial summit of the Thrombosis & Hemostasis Societies of North America.
“More research is needed to determine which children should be targeted for screening for low [bone mineral density], though our research suggests that children with prolonged treatment with steroids may be at the highest risk,” Kavita N. Patel, MD, one of the study’s authors, said in an interview.
“A few studies have shown reduced BMD in children taking warfarin,” she said. “Subsequently, recommendations have been published that children receiving chronic anticoagulation undergo bone density testing. This study sought to determine if children who were receiving chronic anticoagulation [not only warfarin but also low molecular weight heparins and direct oral anticoagulants] had low BMD and whether the length of anticoagulation or any other medical conditions or medications affected the probability of having low BMD. We also wanted to report on the prevalence of low vitamin D in this same group of children since low vitamin D is a known risk for low BMD.”
The study population was a retrospective cohort of children aged 10-21 years who received anticoagulation for more than 1 year at Children’s Healthcare of Atlanta between Jan. 2, 2012, and Oct. 15, 2017. The researchers evaluated a number of factors, including demographic variables, anticoagulants used, vitamin D status, previously reported comorbid conditions and medications associated with changes in BMD. They defined vitamin D deficiency as less than 20 ng/mL and insufficiency as 20-29 ng/mL.
Dr. Patel reported results from 27 males and 23 females. Of these, 15 (30%) underwent bone density testing with dual-energy X-ray absorptiometry; 5 (10%) did not undergo dual-energy X-ray absorptiometry testing because there is no age-specific standardization below the age of 5 years. Nearly half of the patients (42%) were Caucasian, 34% were African American, 16% were Hispanic, and the rest were from other ethnicities. The top four common indications for extended anticoagulation were recurrent venous thromboembolism (26%), extended treatment for deep vein thrombosis (18%), antiphospholipid syndrome (14%), and thrombophilia plus a single venous thromboembolism (14%).
The anticoagulants most often utilized were enoxaparin (59%), warfarin (29%), and rivaroxaban (7%). The most frequent risk factor for low BMD was long-term use of steroids (16%; defined as greater than 6 months of continuous use in the year prior to BMD testing).
Vitamin D deficiency was identified in 52% of subjects who were tested, while another 24% had insufficient levels of vitamin D. Overall, the median lumbar spine z score was –1.4. Five (30%) subjects who completed BMD testing had low BMD, with median z score of –2.5. None met fracture criteria for pediatric osteoporosis. On linear regression, the only factor found to be significantly associated with a BMD lumbar spine z score in chronically anticoagulated children was the long-term use of steroids (P = .04).
Dr. Patel acknowledged certain limitations of the study, including its single-center design and the fact that not all of the children receiving chronic anticoagulation could be tested.
She reported having no financial disclosures.
SOURCE: Patel KN et al. THSNA 2018, Poster 65.
SAN DIEGO – Pediatric hematologists should consider testing for vitamin D deficiency to optimize bone health in children who will be receiving chronic anticoagulation. That’s a key message from a single-center retrospective review presented during a poster session at the biennial summit of the Thrombosis & Hemostasis Societies of North America.
“More research is needed to determine which children should be targeted for screening for low [bone mineral density], though our research suggests that children with prolonged treatment with steroids may be at the highest risk,” Kavita N. Patel, MD, one of the study’s authors, said in an interview.
“A few studies have shown reduced BMD in children taking warfarin,” she said. “Subsequently, recommendations have been published that children receiving chronic anticoagulation undergo bone density testing. This study sought to determine if children who were receiving chronic anticoagulation [not only warfarin but also low molecular weight heparins and direct oral anticoagulants] had low BMD and whether the length of anticoagulation or any other medical conditions or medications affected the probability of having low BMD. We also wanted to report on the prevalence of low vitamin D in this same group of children since low vitamin D is a known risk for low BMD.”
The study population was a retrospective cohort of children aged 10-21 years who received anticoagulation for more than 1 year at Children’s Healthcare of Atlanta between Jan. 2, 2012, and Oct. 15, 2017. The researchers evaluated a number of factors, including demographic variables, anticoagulants used, vitamin D status, previously reported comorbid conditions and medications associated with changes in BMD. They defined vitamin D deficiency as less than 20 ng/mL and insufficiency as 20-29 ng/mL.
Dr. Patel reported results from 27 males and 23 females. Of these, 15 (30%) underwent bone density testing with dual-energy X-ray absorptiometry; 5 (10%) did not undergo dual-energy X-ray absorptiometry testing because there is no age-specific standardization below the age of 5 years. Nearly half of the patients (42%) were Caucasian, 34% were African American, 16% were Hispanic, and the rest were from other ethnicities. The top four common indications for extended anticoagulation were recurrent venous thromboembolism (26%), extended treatment for deep vein thrombosis (18%), antiphospholipid syndrome (14%), and thrombophilia plus a single venous thromboembolism (14%).
The anticoagulants most often utilized were enoxaparin (59%), warfarin (29%), and rivaroxaban (7%). The most frequent risk factor for low BMD was long-term use of steroids (16%; defined as greater than 6 months of continuous use in the year prior to BMD testing).
Vitamin D deficiency was identified in 52% of subjects who were tested, while another 24% had insufficient levels of vitamin D. Overall, the median lumbar spine z score was –1.4. Five (30%) subjects who completed BMD testing had low BMD, with median z score of –2.5. None met fracture criteria for pediatric osteoporosis. On linear regression, the only factor found to be significantly associated with a BMD lumbar spine z score in chronically anticoagulated children was the long-term use of steroids (P = .04).
Dr. Patel acknowledged certain limitations of the study, including its single-center design and the fact that not all of the children receiving chronic anticoagulation could be tested.
She reported having no financial disclosures.
SOURCE: Patel KN et al. THSNA 2018, Poster 65.
REPORTING FROM THSNA 2018
Key clinical point:
Major finding: Of chronically anticoagulated children, 52% were vitamin D deficient and another 24% had insufficient levels of the nutrient.
Study details: A retrospective, single-center cohort study of 50 chronically anticoagulated children.
Disclosures: Dr. Patel reported having no financial disclosures.
Source: Patel KN et al. THSNA 2018, Poster 65.