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The Official Newspaper of the American Association for Thoracic Surgery
Endobronchial valves improve pulmonary function in emphysema
Endobronchial valves improved pulmonary function, exercise capacity, and quality of life in a prospective randomized controlled trial involving 68 adults with severe emphysema, according to a report published online Dec. 10 in the New England Journal of Medicine.
“The improvements we found were of greater magnitude than those noted with pharmacologic treatment in comparable patients and were similar to improvements with surgical lung-volume reduction, but with significantly less morbidity,” said Karin Klooster of the department of pulmonary diseases, University Medical Center Groningen (the Netherlands) and her associates.
Previous research suggested that bronchoscopic lung-volume reduction using one-way endobronchial valves to block inspiratory but not expiratory air flow would be most effective in patients who had a complete rather than an incomplete fissure between the targeted lobe and the adjacent lobe on high-resolution CT. “A complete fissure on HRCT [high-resolution computed tomography] is a surrogate finding for the absence of interlobar collateral ventilation; if there is collateral ventilation, an occluded lobe can be reinflated through its collaterals,” defeating the purpose of the procedure, the researchers wrote.
During a 3-year period, Ms. Klooster and her associates studied emphysema patients who were older than 35 years (mean age, 58-59) and had a postbronchodilator forced expiratory volume in 1 second (FEV1) less than 60% of predicted volume, a total lung capacity more than 100% of the predicted value, and residual volume more than 150% of predicted volume. On HRCT, all the study participants showed a complete or nearly complete fissure between the targeted lobe and the adjacent lobe. They were randomly assigned to receive endobronchial valves (34 patients) or usual care (34 control subjects) and followed for 6 months. At that time, control subjects were allowed to crossover and receive endobronchial valves as well.
The median procedure time was 18 minutes (range, 6-51 minutes), and the median number of valves placed in each patient was 4 (range, 2-7 valves). The median hospital stay was 1 day (range, 1-13 days).
Compared with the control subjects, patients who received endobronchial valves showed a reduction in target lobar volume of 1,366 mL. This was accompanied by improvements in FEV1 by 191 mL, in forced vital capacity by 442 mL, in residual lung volume, in longer 6-minute walk distance by 106 meters, in scores on the Clinical COPD Questionnaire measuring daily functioning, and in scores on the St. George’s Respiratory Questionnaire measuring quality of life. The results for the control subjects who crossed over to the active-treatment group were very similar, the investigators said (N Engl J Med. 2015 Dec 10;373:2325-35. doi:10.1056/NEJMoa1507807).
However, several adverse effects occurred, and close monitoring of this patient population is crucial. The most common complication was pneumothorax, which developed in 6 of the 34 patients (18%), usually within 1 day of undergoing the procedure. Pneumothorax resolved spontaneously in one patient but required chest-tube drainage in the other five; it resolved in one patient after temporary removal of the valves to promote healing, and in another after permanent removal of all valves.
Other adverse effects, some of which required repeat bronchoscopy, included torsion of the lower-lobe bronchus after upper-lobe treatment (two patients), pneumonia distal to the valves (one patient), increased dyspnea and sputum production (two patients), valve migration (two patients), valve dislocation because of granulation-tissue formation (one patient), and persistent cough (one patient). Despite these setbacks, “the overall outcome of treatment was positive,” Ms. Klooster and her associates said.
All patients who underwent valve removal recovered without any further adverse effects, indicating that this treatment “is fully reversible and doesn’t preclude further therapeutic options,” they added.
The study was supported by the Netherlands Organization for Health Research and Development and the University Medical Center Groningen. Ms. Klooster reported receiving fees, devices, travel support, and grant support from Pulmonx and PneumRx/BTG; her associates reported ties to numerous industry sponsors. Pulmonx commercially supplied the endobronchial valves for the study.
Endobronchial valves improved pulmonary function, exercise capacity, and quality of life in a prospective randomized controlled trial involving 68 adults with severe emphysema, according to a report published online Dec. 10 in the New England Journal of Medicine.
“The improvements we found were of greater magnitude than those noted with pharmacologic treatment in comparable patients and were similar to improvements with surgical lung-volume reduction, but with significantly less morbidity,” said Karin Klooster of the department of pulmonary diseases, University Medical Center Groningen (the Netherlands) and her associates.
Previous research suggested that bronchoscopic lung-volume reduction using one-way endobronchial valves to block inspiratory but not expiratory air flow would be most effective in patients who had a complete rather than an incomplete fissure between the targeted lobe and the adjacent lobe on high-resolution CT. “A complete fissure on HRCT [high-resolution computed tomography] is a surrogate finding for the absence of interlobar collateral ventilation; if there is collateral ventilation, an occluded lobe can be reinflated through its collaterals,” defeating the purpose of the procedure, the researchers wrote.
During a 3-year period, Ms. Klooster and her associates studied emphysema patients who were older than 35 years (mean age, 58-59) and had a postbronchodilator forced expiratory volume in 1 second (FEV1) less than 60% of predicted volume, a total lung capacity more than 100% of the predicted value, and residual volume more than 150% of predicted volume. On HRCT, all the study participants showed a complete or nearly complete fissure between the targeted lobe and the adjacent lobe. They were randomly assigned to receive endobronchial valves (34 patients) or usual care (34 control subjects) and followed for 6 months. At that time, control subjects were allowed to crossover and receive endobronchial valves as well.
The median procedure time was 18 minutes (range, 6-51 minutes), and the median number of valves placed in each patient was 4 (range, 2-7 valves). The median hospital stay was 1 day (range, 1-13 days).
Compared with the control subjects, patients who received endobronchial valves showed a reduction in target lobar volume of 1,366 mL. This was accompanied by improvements in FEV1 by 191 mL, in forced vital capacity by 442 mL, in residual lung volume, in longer 6-minute walk distance by 106 meters, in scores on the Clinical COPD Questionnaire measuring daily functioning, and in scores on the St. George’s Respiratory Questionnaire measuring quality of life. The results for the control subjects who crossed over to the active-treatment group were very similar, the investigators said (N Engl J Med. 2015 Dec 10;373:2325-35. doi:10.1056/NEJMoa1507807).
However, several adverse effects occurred, and close monitoring of this patient population is crucial. The most common complication was pneumothorax, which developed in 6 of the 34 patients (18%), usually within 1 day of undergoing the procedure. Pneumothorax resolved spontaneously in one patient but required chest-tube drainage in the other five; it resolved in one patient after temporary removal of the valves to promote healing, and in another after permanent removal of all valves.
Other adverse effects, some of which required repeat bronchoscopy, included torsion of the lower-lobe bronchus after upper-lobe treatment (two patients), pneumonia distal to the valves (one patient), increased dyspnea and sputum production (two patients), valve migration (two patients), valve dislocation because of granulation-tissue formation (one patient), and persistent cough (one patient). Despite these setbacks, “the overall outcome of treatment was positive,” Ms. Klooster and her associates said.
All patients who underwent valve removal recovered without any further adverse effects, indicating that this treatment “is fully reversible and doesn’t preclude further therapeutic options,” they added.
The study was supported by the Netherlands Organization for Health Research and Development and the University Medical Center Groningen. Ms. Klooster reported receiving fees, devices, travel support, and grant support from Pulmonx and PneumRx/BTG; her associates reported ties to numerous industry sponsors. Pulmonx commercially supplied the endobronchial valves for the study.
Endobronchial valves improved pulmonary function, exercise capacity, and quality of life in a prospective randomized controlled trial involving 68 adults with severe emphysema, according to a report published online Dec. 10 in the New England Journal of Medicine.
“The improvements we found were of greater magnitude than those noted with pharmacologic treatment in comparable patients and were similar to improvements with surgical lung-volume reduction, but with significantly less morbidity,” said Karin Klooster of the department of pulmonary diseases, University Medical Center Groningen (the Netherlands) and her associates.
Previous research suggested that bronchoscopic lung-volume reduction using one-way endobronchial valves to block inspiratory but not expiratory air flow would be most effective in patients who had a complete rather than an incomplete fissure between the targeted lobe and the adjacent lobe on high-resolution CT. “A complete fissure on HRCT [high-resolution computed tomography] is a surrogate finding for the absence of interlobar collateral ventilation; if there is collateral ventilation, an occluded lobe can be reinflated through its collaterals,” defeating the purpose of the procedure, the researchers wrote.
During a 3-year period, Ms. Klooster and her associates studied emphysema patients who were older than 35 years (mean age, 58-59) and had a postbronchodilator forced expiratory volume in 1 second (FEV1) less than 60% of predicted volume, a total lung capacity more than 100% of the predicted value, and residual volume more than 150% of predicted volume. On HRCT, all the study participants showed a complete or nearly complete fissure between the targeted lobe and the adjacent lobe. They were randomly assigned to receive endobronchial valves (34 patients) or usual care (34 control subjects) and followed for 6 months. At that time, control subjects were allowed to crossover and receive endobronchial valves as well.
The median procedure time was 18 minutes (range, 6-51 minutes), and the median number of valves placed in each patient was 4 (range, 2-7 valves). The median hospital stay was 1 day (range, 1-13 days).
Compared with the control subjects, patients who received endobronchial valves showed a reduction in target lobar volume of 1,366 mL. This was accompanied by improvements in FEV1 by 191 mL, in forced vital capacity by 442 mL, in residual lung volume, in longer 6-minute walk distance by 106 meters, in scores on the Clinical COPD Questionnaire measuring daily functioning, and in scores on the St. George’s Respiratory Questionnaire measuring quality of life. The results for the control subjects who crossed over to the active-treatment group were very similar, the investigators said (N Engl J Med. 2015 Dec 10;373:2325-35. doi:10.1056/NEJMoa1507807).
However, several adverse effects occurred, and close monitoring of this patient population is crucial. The most common complication was pneumothorax, which developed in 6 of the 34 patients (18%), usually within 1 day of undergoing the procedure. Pneumothorax resolved spontaneously in one patient but required chest-tube drainage in the other five; it resolved in one patient after temporary removal of the valves to promote healing, and in another after permanent removal of all valves.
Other adverse effects, some of which required repeat bronchoscopy, included torsion of the lower-lobe bronchus after upper-lobe treatment (two patients), pneumonia distal to the valves (one patient), increased dyspnea and sputum production (two patients), valve migration (two patients), valve dislocation because of granulation-tissue formation (one patient), and persistent cough (one patient). Despite these setbacks, “the overall outcome of treatment was positive,” Ms. Klooster and her associates said.
All patients who underwent valve removal recovered without any further adverse effects, indicating that this treatment “is fully reversible and doesn’t preclude further therapeutic options,” they added.
The study was supported by the Netherlands Organization for Health Research and Development and the University Medical Center Groningen. Ms. Klooster reported receiving fees, devices, travel support, and grant support from Pulmonx and PneumRx/BTG; her associates reported ties to numerous industry sponsors. Pulmonx commercially supplied the endobronchial valves for the study.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Endobronchial valves improved pulmonary function, exercise capacity, and QOL in severe emphysema.
Major finding: Patients who received endobronchial valves showed improved FEV1 by 191 mL, forced vital capacity by 442 mL, residual lung volume, 6-minute walk distance by 106 meters, and QOL scores.
Data source: A prospective randomized controlled trial involving 68 patients treated during a 3-year period at a single medical center.
Disclosures: The Netherlands Organization for Health Research and Development and the University Medical Center Groningen funded the study. Ms. Klooster reported receiving fees, devices, travel support, and grant support from Pulmonx and PneumRx/BTG; her associates reported ties to numerous industry sponsors. Pulmonx commercially supplied the endobronchial valves for this study.
Analysis finds 28.8% prevalence of depression in residents
The estimated prevalence of depression or depressive symptoms was 28.8% among residents and interns worldwide in a meta-analysis of 54 studies of the issue, according to a report published online December 8 in JAMA.
The depression rate ranged from 20.9% to 43.2%, depending on the instrument used to assess symptoms. Eleven studies used the Beck Depression Inventory (BDI), 11 used the Center for Epidemiological Studies Depression Scale (CES-D), 8 used the two-item Primary Care Evaluation of Mental Disorders questionnaire (PRIME-MD), 7 used the nine-item Patient Health Questionnaire (PHQ-9), 4 used the Zung Self-Rating Depression Scale (SDS), 3 used the Harvard Department of Psychiatry/National Depression Screening Day Scale (HANDS), and 11 used other validated methods, said Dr. Douglas A. Mata of the department of pathology, Brigham and Women’s Hospital and Harvard Medical School, Boston, and his associates.
“It is important to note that the vast majority of participants were assessed through self-report inventories that measured depressive symptoms, rather than gold-standard diagnostic clinical interviews for major depressive disorder,” they said.
The meta-analysis included 31 cross-sectional and 23 longitudinal studies published in peer-reviewed journals since 1963 and involving 17,560 residents or interns in North America (35 studies), Asia (9 studies), Europe (5 studies), South America (4 studies), and Africa (1 study). When the results were pooled, the overall prevalence of depression or depressive symptoms was 28.8% (4,969 of 17,560 participants).
In a sensitivity analysis, no individual study affected the overall prevalence estimate by more than 1%. Further analyses showed no significant differences in the prevalence of depression between cross-sectional and longitudinal studies, between U.S. studies and those performed in other countries, between studies of nonsurgical residents only vs. studies of all types of residents, or between studies of interns only vs. studies of upper level residents only. This suggests that the underlying causes of depressive symptoms “are common to the residency experience,” Dr. Mata and his associates said (JAMA. 2015 Dec 8. doi: 10.1001/jama.2015.15845).
The prevalence of depression increased over time. Although this rise was characterized as modest, “it is notable, given efforts by the Accreditation Council for Graduate Medical Education, European Working Time Directive, and others to limit trainee duty hours and improve work conditions. [This] trend may reflect the medical community’s increased awareness of depression or developments external to medical education. Future studies should explore specific factors that may explain this trend,” the investigators said.
The study findings indicate that the long-term health of physicians may be affected, since depression has been linked to a higher risk of future depressive episodes and greater long-term morbidity. Patient care may also be affected, given the established association between physician depression and lower-quality care, they added.
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Dr. Thomas L. Schwenk |
The meta-analysis by Mata et al. makes it clear that the extent of significant depressive symptomatology, if not overt clinical depression, among physicians-in-training is extraordinarily and unacceptably high. Relieving the burden of depression in these individuals is an issue of professional performance in addition to one of human compassion.
A national conversation about the fundamental structure and function of the graduate medical education system is long overdue, not unlike the discussion that reformed undergraduate medical education after the Flexner Report. The high burden of depressive symptoms among residents and interns has reached a crisis level. It is a marker for deeper and more profound problems in the medical education system, which require equally profound solutions.
Dr. Thomas L. Schwenk is at the University of Nevada, Reno. He reported having no relevant financial disclosures. Dr. Schwenk made these remarks in an editorial accompanying Dr. Mata’s report (JAMA 2015;314:2357-8).
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Dr. Thomas L. Schwenk |
The meta-analysis by Mata et al. makes it clear that the extent of significant depressive symptomatology, if not overt clinical depression, among physicians-in-training is extraordinarily and unacceptably high. Relieving the burden of depression in these individuals is an issue of professional performance in addition to one of human compassion.
A national conversation about the fundamental structure and function of the graduate medical education system is long overdue, not unlike the discussion that reformed undergraduate medical education after the Flexner Report. The high burden of depressive symptoms among residents and interns has reached a crisis level. It is a marker for deeper and more profound problems in the medical education system, which require equally profound solutions.
Dr. Thomas L. Schwenk is at the University of Nevada, Reno. He reported having no relevant financial disclosures. Dr. Schwenk made these remarks in an editorial accompanying Dr. Mata’s report (JAMA 2015;314:2357-8).
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|
Dr. Thomas L. Schwenk |
The meta-analysis by Mata et al. makes it clear that the extent of significant depressive symptomatology, if not overt clinical depression, among physicians-in-training is extraordinarily and unacceptably high. Relieving the burden of depression in these individuals is an issue of professional performance in addition to one of human compassion.
A national conversation about the fundamental structure and function of the graduate medical education system is long overdue, not unlike the discussion that reformed undergraduate medical education after the Flexner Report. The high burden of depressive symptoms among residents and interns has reached a crisis level. It is a marker for deeper and more profound problems in the medical education system, which require equally profound solutions.
Dr. Thomas L. Schwenk is at the University of Nevada, Reno. He reported having no relevant financial disclosures. Dr. Schwenk made these remarks in an editorial accompanying Dr. Mata’s report (JAMA 2015;314:2357-8).
The estimated prevalence of depression or depressive symptoms was 28.8% among residents and interns worldwide in a meta-analysis of 54 studies of the issue, according to a report published online December 8 in JAMA.
The depression rate ranged from 20.9% to 43.2%, depending on the instrument used to assess symptoms. Eleven studies used the Beck Depression Inventory (BDI), 11 used the Center for Epidemiological Studies Depression Scale (CES-D), 8 used the two-item Primary Care Evaluation of Mental Disorders questionnaire (PRIME-MD), 7 used the nine-item Patient Health Questionnaire (PHQ-9), 4 used the Zung Self-Rating Depression Scale (SDS), 3 used the Harvard Department of Psychiatry/National Depression Screening Day Scale (HANDS), and 11 used other validated methods, said Dr. Douglas A. Mata of the department of pathology, Brigham and Women’s Hospital and Harvard Medical School, Boston, and his associates.
“It is important to note that the vast majority of participants were assessed through self-report inventories that measured depressive symptoms, rather than gold-standard diagnostic clinical interviews for major depressive disorder,” they said.
The meta-analysis included 31 cross-sectional and 23 longitudinal studies published in peer-reviewed journals since 1963 and involving 17,560 residents or interns in North America (35 studies), Asia (9 studies), Europe (5 studies), South America (4 studies), and Africa (1 study). When the results were pooled, the overall prevalence of depression or depressive symptoms was 28.8% (4,969 of 17,560 participants).
In a sensitivity analysis, no individual study affected the overall prevalence estimate by more than 1%. Further analyses showed no significant differences in the prevalence of depression between cross-sectional and longitudinal studies, between U.S. studies and those performed in other countries, between studies of nonsurgical residents only vs. studies of all types of residents, or between studies of interns only vs. studies of upper level residents only. This suggests that the underlying causes of depressive symptoms “are common to the residency experience,” Dr. Mata and his associates said (JAMA. 2015 Dec 8. doi: 10.1001/jama.2015.15845).
The prevalence of depression increased over time. Although this rise was characterized as modest, “it is notable, given efforts by the Accreditation Council for Graduate Medical Education, European Working Time Directive, and others to limit trainee duty hours and improve work conditions. [This] trend may reflect the medical community’s increased awareness of depression or developments external to medical education. Future studies should explore specific factors that may explain this trend,” the investigators said.
The study findings indicate that the long-term health of physicians may be affected, since depression has been linked to a higher risk of future depressive episodes and greater long-term morbidity. Patient care may also be affected, given the established association between physician depression and lower-quality care, they added.
The estimated prevalence of depression or depressive symptoms was 28.8% among residents and interns worldwide in a meta-analysis of 54 studies of the issue, according to a report published online December 8 in JAMA.
The depression rate ranged from 20.9% to 43.2%, depending on the instrument used to assess symptoms. Eleven studies used the Beck Depression Inventory (BDI), 11 used the Center for Epidemiological Studies Depression Scale (CES-D), 8 used the two-item Primary Care Evaluation of Mental Disorders questionnaire (PRIME-MD), 7 used the nine-item Patient Health Questionnaire (PHQ-9), 4 used the Zung Self-Rating Depression Scale (SDS), 3 used the Harvard Department of Psychiatry/National Depression Screening Day Scale (HANDS), and 11 used other validated methods, said Dr. Douglas A. Mata of the department of pathology, Brigham and Women’s Hospital and Harvard Medical School, Boston, and his associates.
“It is important to note that the vast majority of participants were assessed through self-report inventories that measured depressive symptoms, rather than gold-standard diagnostic clinical interviews for major depressive disorder,” they said.
The meta-analysis included 31 cross-sectional and 23 longitudinal studies published in peer-reviewed journals since 1963 and involving 17,560 residents or interns in North America (35 studies), Asia (9 studies), Europe (5 studies), South America (4 studies), and Africa (1 study). When the results were pooled, the overall prevalence of depression or depressive symptoms was 28.8% (4,969 of 17,560 participants).
In a sensitivity analysis, no individual study affected the overall prevalence estimate by more than 1%. Further analyses showed no significant differences in the prevalence of depression between cross-sectional and longitudinal studies, between U.S. studies and those performed in other countries, between studies of nonsurgical residents only vs. studies of all types of residents, or between studies of interns only vs. studies of upper level residents only. This suggests that the underlying causes of depressive symptoms “are common to the residency experience,” Dr. Mata and his associates said (JAMA. 2015 Dec 8. doi: 10.1001/jama.2015.15845).
The prevalence of depression increased over time. Although this rise was characterized as modest, “it is notable, given efforts by the Accreditation Council for Graduate Medical Education, European Working Time Directive, and others to limit trainee duty hours and improve work conditions. [This] trend may reflect the medical community’s increased awareness of depression or developments external to medical education. Future studies should explore specific factors that may explain this trend,” the investigators said.
The study findings indicate that the long-term health of physicians may be affected, since depression has been linked to a higher risk of future depressive episodes and greater long-term morbidity. Patient care may also be affected, given the established association between physician depression and lower-quality care, they added.
FROM JAMA
Key clinical point: The prevalence of depression or depressive symptoms was 28.8% (range, 20.9%-43.2%) among residents in a meta-analysis of 54 studies.
Major finding: The overall prevalence of depression or depressive symptoms was 28.8% (4,969 of 17,560 participants) across all countries, all types of studies, and all types of graduate medical education programs.
Data source: A meta-analysis of 31 cross-sectional and 23 longitudinal studies involving 17,560 residents and interns worldwide.
Disclosures: This study was supported by the U.S. Department of State Fulbright Scholarship program, the National Institutes of Health, and the NIH Medical Scientist Training Program. Dr. Mata and his associates reported having no relevant financial disclosures.
AHA: COPD doubles sudden cardiac death risk in hypertensives
ORLANDO – A second, confirmatory major study has shown that chronic obstructive pulmonary disease independently increases the risk of sudden cardiac death severalfold.
COPD was associated with a roughly twofold increased risk of sudden cardiac death (SCD) in hypertensive patients with COPD, compared with those without the pulmonary disease, in the Scandinavian Losartan Intervention for Endpoint Reduction in Hypertension (LIFE) trial, Dr. Peter M. Okin reported at the American Heart Association scientific sessions.
Moreover, aggressive blood pressure lowering in the hypertensive COPD patients didn’t negate this risk, added Dr. Okin of Cornell University in New York.
The impetus for his secondary analysis of LIFE data was an earlier report from the landmark, population-based Rotterdam Heart Study. Among 1,615 participants with COPD, the age- and sex-adjusted risk of SCD was 1.34-fold greater than in nearly 12,000 controls. This increased SCD risk climbed to 2.12-fold during the first 2,000 days following diagnosis of COPD and reached 3.58-fold among those with frequent COPD exacerbations during this period (Eur Heart J. 2015 Jul 14;36[27]:1754-61).
Dr. Okin’s secondary analysis of LIFE data included 9,193 hypertensive subjects with ECG evidence of left ventricular hypertrophy who were randomized to lisinopril- or atenolol-based blood pressure lowering to a target of 140/90 mm Hg or less. A history of COPD was present in 385 patients (4.2%) at enrollment.
During a mean 4.8 years of prospective follow-up, 178 patients experienced SCD, a prespecified secondary endpoint in the LIFE trial. The incidence rate was 9 cases per 1,000 patient-years in those with COPD and 3.8 per 1,000 person-years in those without the pulmonary disease.
In a univariate analysis, a history of COPD was associated with a 2.36-fold increased risk of SCD during follow-up. In a multivariate analysis extensively adjusted for potential confounders – treatment arm, age, race, gender, history of atrial fibrillation, baseline serum creatinine and serum glucose, stroke or TIA, as well as on-treatment blood pressure, heart rate, QRS duration, HDL cholesterol level, use of a statin or hydrochlorothiazide, and incident MI or heart failure – COPD remained associated with a 1.82-fold increased risk of SCD, the cardiologist reported.
“These results suggest the need for additional studies to assess whether there are targeted therapies that can reduce the risk of SCD in patients with COPD,” he concluded.
As previously reported, the main finding in LIFE was that losartan conferred benefits beyond blood pressure control (Lancet. 2002 Mar 23;359[9311]:995-1003).
Dr. Okin reported serving as a consultant to Novartis.
ORLANDO – A second, confirmatory major study has shown that chronic obstructive pulmonary disease independently increases the risk of sudden cardiac death severalfold.
COPD was associated with a roughly twofold increased risk of sudden cardiac death (SCD) in hypertensive patients with COPD, compared with those without the pulmonary disease, in the Scandinavian Losartan Intervention for Endpoint Reduction in Hypertension (LIFE) trial, Dr. Peter M. Okin reported at the American Heart Association scientific sessions.
Moreover, aggressive blood pressure lowering in the hypertensive COPD patients didn’t negate this risk, added Dr. Okin of Cornell University in New York.
The impetus for his secondary analysis of LIFE data was an earlier report from the landmark, population-based Rotterdam Heart Study. Among 1,615 participants with COPD, the age- and sex-adjusted risk of SCD was 1.34-fold greater than in nearly 12,000 controls. This increased SCD risk climbed to 2.12-fold during the first 2,000 days following diagnosis of COPD and reached 3.58-fold among those with frequent COPD exacerbations during this period (Eur Heart J. 2015 Jul 14;36[27]:1754-61).
Dr. Okin’s secondary analysis of LIFE data included 9,193 hypertensive subjects with ECG evidence of left ventricular hypertrophy who were randomized to lisinopril- or atenolol-based blood pressure lowering to a target of 140/90 mm Hg or less. A history of COPD was present in 385 patients (4.2%) at enrollment.
During a mean 4.8 years of prospective follow-up, 178 patients experienced SCD, a prespecified secondary endpoint in the LIFE trial. The incidence rate was 9 cases per 1,000 patient-years in those with COPD and 3.8 per 1,000 person-years in those without the pulmonary disease.
In a univariate analysis, a history of COPD was associated with a 2.36-fold increased risk of SCD during follow-up. In a multivariate analysis extensively adjusted for potential confounders – treatment arm, age, race, gender, history of atrial fibrillation, baseline serum creatinine and serum glucose, stroke or TIA, as well as on-treatment blood pressure, heart rate, QRS duration, HDL cholesterol level, use of a statin or hydrochlorothiazide, and incident MI or heart failure – COPD remained associated with a 1.82-fold increased risk of SCD, the cardiologist reported.
“These results suggest the need for additional studies to assess whether there are targeted therapies that can reduce the risk of SCD in patients with COPD,” he concluded.
As previously reported, the main finding in LIFE was that losartan conferred benefits beyond blood pressure control (Lancet. 2002 Mar 23;359[9311]:995-1003).
Dr. Okin reported serving as a consultant to Novartis.
ORLANDO – A second, confirmatory major study has shown that chronic obstructive pulmonary disease independently increases the risk of sudden cardiac death severalfold.
COPD was associated with a roughly twofold increased risk of sudden cardiac death (SCD) in hypertensive patients with COPD, compared with those without the pulmonary disease, in the Scandinavian Losartan Intervention for Endpoint Reduction in Hypertension (LIFE) trial, Dr. Peter M. Okin reported at the American Heart Association scientific sessions.
Moreover, aggressive blood pressure lowering in the hypertensive COPD patients didn’t negate this risk, added Dr. Okin of Cornell University in New York.
The impetus for his secondary analysis of LIFE data was an earlier report from the landmark, population-based Rotterdam Heart Study. Among 1,615 participants with COPD, the age- and sex-adjusted risk of SCD was 1.34-fold greater than in nearly 12,000 controls. This increased SCD risk climbed to 2.12-fold during the first 2,000 days following diagnosis of COPD and reached 3.58-fold among those with frequent COPD exacerbations during this period (Eur Heart J. 2015 Jul 14;36[27]:1754-61).
Dr. Okin’s secondary analysis of LIFE data included 9,193 hypertensive subjects with ECG evidence of left ventricular hypertrophy who were randomized to lisinopril- or atenolol-based blood pressure lowering to a target of 140/90 mm Hg or less. A history of COPD was present in 385 patients (4.2%) at enrollment.
During a mean 4.8 years of prospective follow-up, 178 patients experienced SCD, a prespecified secondary endpoint in the LIFE trial. The incidence rate was 9 cases per 1,000 patient-years in those with COPD and 3.8 per 1,000 person-years in those without the pulmonary disease.
In a univariate analysis, a history of COPD was associated with a 2.36-fold increased risk of SCD during follow-up. In a multivariate analysis extensively adjusted for potential confounders – treatment arm, age, race, gender, history of atrial fibrillation, baseline serum creatinine and serum glucose, stroke or TIA, as well as on-treatment blood pressure, heart rate, QRS duration, HDL cholesterol level, use of a statin or hydrochlorothiazide, and incident MI or heart failure – COPD remained associated with a 1.82-fold increased risk of SCD, the cardiologist reported.
“These results suggest the need for additional studies to assess whether there are targeted therapies that can reduce the risk of SCD in patients with COPD,” he concluded.
As previously reported, the main finding in LIFE was that losartan conferred benefits beyond blood pressure control (Lancet. 2002 Mar 23;359[9311]:995-1003).
Dr. Okin reported serving as a consultant to Novartis.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point: Two large studies link chronic obstructive pulmonary disease with increased risk of sudden cardiac death.
Major finding: Patients with COPD and hypertension had nearly a twofold increased risk of sudden cardiac death, compared with hypertensives without the pulmonary disease.
Data source: This was a secondary analysis comparing sudden cardiac death rates in 385 hypertensive patients with and nearly 12,000 without COPD, all participants in the LIFE trial.
Disclosures: The presenter reported serving as a consultant to Novartis.
Diabetes raises the cardiovascular risk higher in women than men
Women with type 2 diabetes mellitus have a twofold greater risk of developing coronary heart disease, compared with men with type 2 diabetes, according to a scientific statement from the American Heart Association.
In outlining the many sex differences in the impact of diabetes on cardiovascular disease risk, the authors of the statement have also called for more research into why there are these sex differences and how to treat them.
Around 1 in 10 adult Americans are estimated to have diabetes, and among those individuals, cardiovascular disease alone accounts for more than three-quarters of hospitalizations and half of all deaths.
“Although nondiabetic women have fewer cardiovascular events than nondiabetic men of the same age, this advantage appears to be lost in the context of [type 2 diabetes],” wrote American Heart Association Diabetes Committee Cochair Dr. Judith G. Regensteiner, director of the Center for Women’s Health Research at the University of Colorado at Denver, Aurora, and her coauthors.
Women with type 2 diabetes experience myocardial infarctions earlier in life than do men and are more likely to die from them, yet the rates of revascularization are lower in women with diabetes, compared with men, according to a statement published in the December 7 online issue of Circulation.
Women with diabetes also have more impaired endothelium-dependent vasodilation, worse atherogenic dyslipidemia, prothrombotic coagulation profile and higher metabolic syndrome prevalence than men with diabetes (Circulation. 2015 Dec 7. doi: 10.1161/CIR.0000000000000343).
Diabetes is also associated with a greater risk of incident heart failure and is a stronger risk factor for stroke in women than in men, although men with stroke are more likely to have diabetes.
Black and Hispanic women with type 2 diabetes also experience a disproportionately larger impact of the disease on their coronary artery disease and stroke risk, compared with men.
The authors of the statement also observed that, compared with men with diabetes, women are less likely to be taking statins, aspirin, ACE inhibitors, or beta-blockers, with the suggestion of lower medication adherence in women.
While the overall prevalence of diabetes is similar in men and women, there are sex-specific conditions such as gestational diabetes and polycystic ovary syndrome that contribute to women’s risk of the disease.
Research is needed to explore the full extent of sex differences between men and women, as this may have therapeutic implications, Dr. Regensteiner said in an interview.
“There really isn’t too much a clinician can do differently at this point because we don’t have information to guide changes in therapy,” she said, noting that any potential heart problems should be subject to the same level of scrutiny in women as in men.
The authors of the statement pointed out that observational evidence suggested women with diabetes may benefit from a higher frequency and intensity of physical activity than men with diabetes, and women with type 1 diabetes may experience greater improvements in hemoglobin A1c with exercise, compared with men.
The American Heart Association issued the statement. Several authors declared research grants or consultancies from the pharmaceutical industry or ownership interests in private companies.
Women with type 2 diabetes mellitus have a twofold greater risk of developing coronary heart disease, compared with men with type 2 diabetes, according to a scientific statement from the American Heart Association.
In outlining the many sex differences in the impact of diabetes on cardiovascular disease risk, the authors of the statement have also called for more research into why there are these sex differences and how to treat them.
Around 1 in 10 adult Americans are estimated to have diabetes, and among those individuals, cardiovascular disease alone accounts for more than three-quarters of hospitalizations and half of all deaths.
“Although nondiabetic women have fewer cardiovascular events than nondiabetic men of the same age, this advantage appears to be lost in the context of [type 2 diabetes],” wrote American Heart Association Diabetes Committee Cochair Dr. Judith G. Regensteiner, director of the Center for Women’s Health Research at the University of Colorado at Denver, Aurora, and her coauthors.
Women with type 2 diabetes experience myocardial infarctions earlier in life than do men and are more likely to die from them, yet the rates of revascularization are lower in women with diabetes, compared with men, according to a statement published in the December 7 online issue of Circulation.
Women with diabetes also have more impaired endothelium-dependent vasodilation, worse atherogenic dyslipidemia, prothrombotic coagulation profile and higher metabolic syndrome prevalence than men with diabetes (Circulation. 2015 Dec 7. doi: 10.1161/CIR.0000000000000343).
Diabetes is also associated with a greater risk of incident heart failure and is a stronger risk factor for stroke in women than in men, although men with stroke are more likely to have diabetes.
Black and Hispanic women with type 2 diabetes also experience a disproportionately larger impact of the disease on their coronary artery disease and stroke risk, compared with men.
The authors of the statement also observed that, compared with men with diabetes, women are less likely to be taking statins, aspirin, ACE inhibitors, or beta-blockers, with the suggestion of lower medication adherence in women.
While the overall prevalence of diabetes is similar in men and women, there are sex-specific conditions such as gestational diabetes and polycystic ovary syndrome that contribute to women’s risk of the disease.
Research is needed to explore the full extent of sex differences between men and women, as this may have therapeutic implications, Dr. Regensteiner said in an interview.
“There really isn’t too much a clinician can do differently at this point because we don’t have information to guide changes in therapy,” she said, noting that any potential heart problems should be subject to the same level of scrutiny in women as in men.
The authors of the statement pointed out that observational evidence suggested women with diabetes may benefit from a higher frequency and intensity of physical activity than men with diabetes, and women with type 1 diabetes may experience greater improvements in hemoglobin A1c with exercise, compared with men.
The American Heart Association issued the statement. Several authors declared research grants or consultancies from the pharmaceutical industry or ownership interests in private companies.
Women with type 2 diabetes mellitus have a twofold greater risk of developing coronary heart disease, compared with men with type 2 diabetes, according to a scientific statement from the American Heart Association.
In outlining the many sex differences in the impact of diabetes on cardiovascular disease risk, the authors of the statement have also called for more research into why there are these sex differences and how to treat them.
Around 1 in 10 adult Americans are estimated to have diabetes, and among those individuals, cardiovascular disease alone accounts for more than three-quarters of hospitalizations and half of all deaths.
“Although nondiabetic women have fewer cardiovascular events than nondiabetic men of the same age, this advantage appears to be lost in the context of [type 2 diabetes],” wrote American Heart Association Diabetes Committee Cochair Dr. Judith G. Regensteiner, director of the Center for Women’s Health Research at the University of Colorado at Denver, Aurora, and her coauthors.
Women with type 2 diabetes experience myocardial infarctions earlier in life than do men and are more likely to die from them, yet the rates of revascularization are lower in women with diabetes, compared with men, according to a statement published in the December 7 online issue of Circulation.
Women with diabetes also have more impaired endothelium-dependent vasodilation, worse atherogenic dyslipidemia, prothrombotic coagulation profile and higher metabolic syndrome prevalence than men with diabetes (Circulation. 2015 Dec 7. doi: 10.1161/CIR.0000000000000343).
Diabetes is also associated with a greater risk of incident heart failure and is a stronger risk factor for stroke in women than in men, although men with stroke are more likely to have diabetes.
Black and Hispanic women with type 2 diabetes also experience a disproportionately larger impact of the disease on their coronary artery disease and stroke risk, compared with men.
The authors of the statement also observed that, compared with men with diabetes, women are less likely to be taking statins, aspirin, ACE inhibitors, or beta-blockers, with the suggestion of lower medication adherence in women.
While the overall prevalence of diabetes is similar in men and women, there are sex-specific conditions such as gestational diabetes and polycystic ovary syndrome that contribute to women’s risk of the disease.
Research is needed to explore the full extent of sex differences between men and women, as this may have therapeutic implications, Dr. Regensteiner said in an interview.
“There really isn’t too much a clinician can do differently at this point because we don’t have information to guide changes in therapy,” she said, noting that any potential heart problems should be subject to the same level of scrutiny in women as in men.
The authors of the statement pointed out that observational evidence suggested women with diabetes may benefit from a higher frequency and intensity of physical activity than men with diabetes, and women with type 1 diabetes may experience greater improvements in hemoglobin A1c with exercise, compared with men.
The American Heart Association issued the statement. Several authors declared research grants or consultancies from the pharmaceutical industry or ownership interests in private companies.
FROM CIRCULATION
Key clinical point: There are significant sex differences in the impact of diabetes on cardiovascular risk.
Major finding: Women with diabetes have a greater than twofold risk of coronary artery disease, compared with men with diabetes.
Data source: Scientific statement from the American Heart Association.
Disclosures: The statement is produced by the American Heart Association. Several authors declared research grants or consultancies from the pharmaceutical industry or ownership interests in private companies.
Health spending growth soars after years of low growth
Five years of low growth in national health spending expenditures reversed substantially in 2014, driven by new Affordable Care Act coverage mandates and higher prescription drug spending, largely for new hepatitis C treatments.
U.S. health spending climbed to $3 trillion and grew by 5.3%, as compared with 2013 when growth was 2.9%. Per capita spending in 2014 was up 4.5% to $9,523 from $9,115 in 2013, according to Centers for Medicare & Medicaid Services Office of the Actuary (Health Affairs. 2015 Dec 2 doi: 10.1377/hlthaff.2015.1194).
Anne B. Martin, an economist with actuary’s office, said the 2014 numbers reversed several years of historically low spending growth that tracked with the sluggish economy. She attributed the uptick in growth to the ACA’s access mandates as well as prescription drug purchases, namely those for HCV, which added $11.3 billion in new spending.
“We can’t necessarily say that the [low-growth] cycle has been broken, but this 2014 phenomenon is driven primarily by the ACA expansion and the one-time impact of bringing the new hepatitis C drug into the 2014 mix,” Ms. Martin said.
Between 2013 and 2014, 8.7 million additional patients were enrolled in public and private health insurance, bringing the total insured share of the population from 86% to 88.8%, the highest coverage rate since 1987, according to Ms. Martin and her colleagues.
The growth rate for private health insurance spending went from 1.6% in 2013 to 4.4% in 2014. The $991 billion spent reflected the addition of 2.2 million newly insured patients, and higher rates of spending on medications, clinical services, and inpatient care, compared with 2013.
Federal government spending grew the fastest in 2014 at 11.7%, an 8.2% faster growth rate than in 2013.
In 2014, 28% of all health care purchases were made by the federal government, up from 26% in 2013.
Medicaid-specific spending totaled $495.8 billion, an 11% growth rate in 2014, up from 5.9% in 2013, reflecting the addition of 7.7 million Medicaid enrollees, various increases in prescription drug rebates, and updated provider fees.
Medicare spending jumped to 5.5%, up from 3.0% in 2013, largely due to prescription drugs, although Micah Hartman, a statistician in the Office of the Actuary, said that the per-enrollee spending rate was 2.4% in 2014, up from –0.2% in 2013, which was due to physician and clinical services, higher administrative costs, as well as the net cost of insurance, including fees and administrative costs.
Mr. Hartman singled out Medicare Advantage as a key contributor, noting that the 9.7% increase in growth for that program was from ACA-stipulated fees.
Overall, pharmaceutical spending was $297.7 billion in 2014, according to the report, attributable to novel HCV drugs, other new treatments, fewer-than-normal patent expirations and, in some cases, a doubling of the costs for certain brand-name drugs. The overall 2014 pharmaceutical expenditure growth rate was 12.2%, compared with 2.4% in 2013, the largest differential since 2002.
Physician and clinical services in 2014 went from a growth rate of 2.5% to 4.6%, with total spending at $603.7 billion. Hospital spending last year was $971.8 billion, with a spending growth rate of 4.1%, compared with 3.5% in 2013.
On Twitter @whitneymcknight
Five years of low growth in national health spending expenditures reversed substantially in 2014, driven by new Affordable Care Act coverage mandates and higher prescription drug spending, largely for new hepatitis C treatments.
U.S. health spending climbed to $3 trillion and grew by 5.3%, as compared with 2013 when growth was 2.9%. Per capita spending in 2014 was up 4.5% to $9,523 from $9,115 in 2013, according to Centers for Medicare & Medicaid Services Office of the Actuary (Health Affairs. 2015 Dec 2 doi: 10.1377/hlthaff.2015.1194).
Anne B. Martin, an economist with actuary’s office, said the 2014 numbers reversed several years of historically low spending growth that tracked with the sluggish economy. She attributed the uptick in growth to the ACA’s access mandates as well as prescription drug purchases, namely those for HCV, which added $11.3 billion in new spending.
“We can’t necessarily say that the [low-growth] cycle has been broken, but this 2014 phenomenon is driven primarily by the ACA expansion and the one-time impact of bringing the new hepatitis C drug into the 2014 mix,” Ms. Martin said.
Between 2013 and 2014, 8.7 million additional patients were enrolled in public and private health insurance, bringing the total insured share of the population from 86% to 88.8%, the highest coverage rate since 1987, according to Ms. Martin and her colleagues.
The growth rate for private health insurance spending went from 1.6% in 2013 to 4.4% in 2014. The $991 billion spent reflected the addition of 2.2 million newly insured patients, and higher rates of spending on medications, clinical services, and inpatient care, compared with 2013.
Federal government spending grew the fastest in 2014 at 11.7%, an 8.2% faster growth rate than in 2013.
In 2014, 28% of all health care purchases were made by the federal government, up from 26% in 2013.
Medicaid-specific spending totaled $495.8 billion, an 11% growth rate in 2014, up from 5.9% in 2013, reflecting the addition of 7.7 million Medicaid enrollees, various increases in prescription drug rebates, and updated provider fees.
Medicare spending jumped to 5.5%, up from 3.0% in 2013, largely due to prescription drugs, although Micah Hartman, a statistician in the Office of the Actuary, said that the per-enrollee spending rate was 2.4% in 2014, up from –0.2% in 2013, which was due to physician and clinical services, higher administrative costs, as well as the net cost of insurance, including fees and administrative costs.
Mr. Hartman singled out Medicare Advantage as a key contributor, noting that the 9.7% increase in growth for that program was from ACA-stipulated fees.
Overall, pharmaceutical spending was $297.7 billion in 2014, according to the report, attributable to novel HCV drugs, other new treatments, fewer-than-normal patent expirations and, in some cases, a doubling of the costs for certain brand-name drugs. The overall 2014 pharmaceutical expenditure growth rate was 12.2%, compared with 2.4% in 2013, the largest differential since 2002.
Physician and clinical services in 2014 went from a growth rate of 2.5% to 4.6%, with total spending at $603.7 billion. Hospital spending last year was $971.8 billion, with a spending growth rate of 4.1%, compared with 3.5% in 2013.
On Twitter @whitneymcknight
Five years of low growth in national health spending expenditures reversed substantially in 2014, driven by new Affordable Care Act coverage mandates and higher prescription drug spending, largely for new hepatitis C treatments.
U.S. health spending climbed to $3 trillion and grew by 5.3%, as compared with 2013 when growth was 2.9%. Per capita spending in 2014 was up 4.5% to $9,523 from $9,115 in 2013, according to Centers for Medicare & Medicaid Services Office of the Actuary (Health Affairs. 2015 Dec 2 doi: 10.1377/hlthaff.2015.1194).
Anne B. Martin, an economist with actuary’s office, said the 2014 numbers reversed several years of historically low spending growth that tracked with the sluggish economy. She attributed the uptick in growth to the ACA’s access mandates as well as prescription drug purchases, namely those for HCV, which added $11.3 billion in new spending.
“We can’t necessarily say that the [low-growth] cycle has been broken, but this 2014 phenomenon is driven primarily by the ACA expansion and the one-time impact of bringing the new hepatitis C drug into the 2014 mix,” Ms. Martin said.
Between 2013 and 2014, 8.7 million additional patients were enrolled in public and private health insurance, bringing the total insured share of the population from 86% to 88.8%, the highest coverage rate since 1987, according to Ms. Martin and her colleagues.
The growth rate for private health insurance spending went from 1.6% in 2013 to 4.4% in 2014. The $991 billion spent reflected the addition of 2.2 million newly insured patients, and higher rates of spending on medications, clinical services, and inpatient care, compared with 2013.
Federal government spending grew the fastest in 2014 at 11.7%, an 8.2% faster growth rate than in 2013.
In 2014, 28% of all health care purchases were made by the federal government, up from 26% in 2013.
Medicaid-specific spending totaled $495.8 billion, an 11% growth rate in 2014, up from 5.9% in 2013, reflecting the addition of 7.7 million Medicaid enrollees, various increases in prescription drug rebates, and updated provider fees.
Medicare spending jumped to 5.5%, up from 3.0% in 2013, largely due to prescription drugs, although Micah Hartman, a statistician in the Office of the Actuary, said that the per-enrollee spending rate was 2.4% in 2014, up from –0.2% in 2013, which was due to physician and clinical services, higher administrative costs, as well as the net cost of insurance, including fees and administrative costs.
Mr. Hartman singled out Medicare Advantage as a key contributor, noting that the 9.7% increase in growth for that program was from ACA-stipulated fees.
Overall, pharmaceutical spending was $297.7 billion in 2014, according to the report, attributable to novel HCV drugs, other new treatments, fewer-than-normal patent expirations and, in some cases, a doubling of the costs for certain brand-name drugs. The overall 2014 pharmaceutical expenditure growth rate was 12.2%, compared with 2.4% in 2013, the largest differential since 2002.
Physician and clinical services in 2014 went from a growth rate of 2.5% to 4.6%, with total spending at $603.7 billion. Hospital spending last year was $971.8 billion, with a spending growth rate of 4.1%, compared with 3.5% in 2013.
On Twitter @whitneymcknight
FROM THE JOURNAL HEALTH AFFAIRS
Readmission after esophagectomy raises mortality
About one in five patients who have surgery to remove part or all of the esophagus return to the hospital for complications within 30 days, and when they do their chance of death increases fivefold, compared with those who don’t return to the hospital, investigators at the University of Virginia Health System reported in the Journal of Thoracic and Cardiovascular Surgery (2015;150:1254-60).
“Early recognition of life-threatening readmission diagnoses is essential in order to provide optimal care,” said lead author Dr. Yinin Hu and colleagues. Esophageal cancer is the fastest-growing cancer in the United States, so the study investigators set out to closely examine the reasons for readmissions and death after surgery.
The study identified 1,688 patients in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database aged 66 or older who had surgery for esophageal cancer from 2000 to 2009. The overall 30-day mortality was 6.9%, and the 90-day mortality was 13.9%.
After excluding in-hospital deaths, the investigators’ readmission analysis included 1,543 patients. In this group, overall 90-day mortality following discharge was 6.4%, and the readmission rate within 30 days of discharge was 20.7%
The 90-day mortality for patients who were readmitted was more than four times that for those who were not readmitted, 16.3% vs. 3.8%; their in-hospital mortality was 8.8%. About one-third of readmissions were to facilities different from where patients had the index esophagectomy, and those patients were about seven times more likely to be transferred after readmission than patients admitted to the same facility, 15% vs. 1.9%. Risk-adjusted mortality did not vary significantly across providers.
The most frequent reasons for readmission were pneumonia (11.8%), malnutrition/dehydration (8.1%), pleural effusion (97.5%), and aspiration pneumonitis (6.8%). “Notably, more than one in five patients readmitted with a pulmonary diagnosis subsequently died within 90 days of the operation,” Dr. Hu and coauthors said, indicating that readmissions for pulmonary complications carried the worst prognosis.
This is the first study to demonstrate the gravity of pulmonary readmissions within 30 days of discharge, Dr. Hu and coauthors said. “Patients with nonspecific dyspneic symptoms or small pleural effusions should receive aggressive care upon readmission, as more than 20% will not survive the next few months,” Dr. Hu and coauthors said. “These results reinforce the notion that a fairly benign readmitting diagnosis is often an indicator of a much more severe root process.”
Among nonpulmonary reasons for readmission, dehydration and malnutrition carried the highest risk for death. “While there are many interventions that can promote postoperative nutrition, a readmission due to poor dietary tolerance often indicates other complications such as infection, stenosis, or anastomotic leak,” Dr. Hu and coauthors said. They suggested a thorough root-cause analysis should be part of every readmission.
The study also analyzed the hospital length of stay (LOS) as a predictor for readmission. The median LOS was 13 days, but the most common LOS was 9 days. “In general, the probability of readmission increases with increasing postoperative LOS,” Dr. Hu and colleagues said.
The authors reported no disclosures. Dr. Yinin Hu received funding from the National Institutes of Health and coauthor Dr. Benjamin Kozower received funding from the Agency for Healthcare Research and Quality.
The findings of this study may indicate that patients who stay in the hospital longer have underlying issues that did not surface during their admission for the operation, Dr. Anthony W. Kim of Yale University, New Haven, Conn., said in his invited commentary (J Thorac Cardiovasc Surg. 2015;150:1030-1). “Therefore, rather than employing a prevention of a failure-to-rescue strategy during a readmission, it may be worthwhile to enact a prevention-of-readmission strategy triggered by a longer than typical [length of stay],” Dr. Kim said. He suggested the root-cause analysis should begin in the hospital on the day after the patient exceeds the median length of stay.
|
Dr. Anthony W. Kim |
But citing the law of unintended consequences, Dr. Kim warns against using readmission as a quality metric as well a instrument to dictate reimbursement. “The law of unintended consequences dictates that when a readmission is taken out of context, using this measure raises the potential conflict of interest between doing what is right for the patient and achieving a specific milestone that may not be in the best interest of an individual patient,” he said. “Discharging a patient early perhaps to the exclusion of adequately addressing inpatient issues for the purposes of achieving a target [length of stay] is perhaps the prime example of these conflicting interests.”
Because of the difficult recovery course after esophagectomy, some readmissions are “necessary, beneficial and, unequivocally, the right decision,” Dr. Kim said. “Ironically, one of the unintended consequences of this article may be that it exposes the fact that until a better system of recording and scrutinizing readmissions exists, governing organizations should exercise considerable caution when assessing a surgeon, hospital, or system and their readmissions,” he said.
To paraphrase the sociologist Robert K. Merton, who devised the law of unintended consequences, the existing state of knowledge limits one’s ability to anticipate the consequences of action. The authors of this study “have added immensely to a body of knowledge that is still growing and deserves ongoing study if policy is to be based upon it,” Dr. Kim said.
Dr. Kim had no disclosures.
The findings of this study may indicate that patients who stay in the hospital longer have underlying issues that did not surface during their admission for the operation, Dr. Anthony W. Kim of Yale University, New Haven, Conn., said in his invited commentary (J Thorac Cardiovasc Surg. 2015;150:1030-1). “Therefore, rather than employing a prevention of a failure-to-rescue strategy during a readmission, it may be worthwhile to enact a prevention-of-readmission strategy triggered by a longer than typical [length of stay],” Dr. Kim said. He suggested the root-cause analysis should begin in the hospital on the day after the patient exceeds the median length of stay.
|
|
Dr. Anthony W. Kim |
But citing the law of unintended consequences, Dr. Kim warns against using readmission as a quality metric as well a instrument to dictate reimbursement. “The law of unintended consequences dictates that when a readmission is taken out of context, using this measure raises the potential conflict of interest between doing what is right for the patient and achieving a specific milestone that may not be in the best interest of an individual patient,” he said. “Discharging a patient early perhaps to the exclusion of adequately addressing inpatient issues for the purposes of achieving a target [length of stay] is perhaps the prime example of these conflicting interests.”
Because of the difficult recovery course after esophagectomy, some readmissions are “necessary, beneficial and, unequivocally, the right decision,” Dr. Kim said. “Ironically, one of the unintended consequences of this article may be that it exposes the fact that until a better system of recording and scrutinizing readmissions exists, governing organizations should exercise considerable caution when assessing a surgeon, hospital, or system and their readmissions,” he said.
To paraphrase the sociologist Robert K. Merton, who devised the law of unintended consequences, the existing state of knowledge limits one’s ability to anticipate the consequences of action. The authors of this study “have added immensely to a body of knowledge that is still growing and deserves ongoing study if policy is to be based upon it,” Dr. Kim said.
Dr. Kim had no disclosures.
The findings of this study may indicate that patients who stay in the hospital longer have underlying issues that did not surface during their admission for the operation, Dr. Anthony W. Kim of Yale University, New Haven, Conn., said in his invited commentary (J Thorac Cardiovasc Surg. 2015;150:1030-1). “Therefore, rather than employing a prevention of a failure-to-rescue strategy during a readmission, it may be worthwhile to enact a prevention-of-readmission strategy triggered by a longer than typical [length of stay],” Dr. Kim said. He suggested the root-cause analysis should begin in the hospital on the day after the patient exceeds the median length of stay.
|
|
Dr. Anthony W. Kim |
But citing the law of unintended consequences, Dr. Kim warns against using readmission as a quality metric as well a instrument to dictate reimbursement. “The law of unintended consequences dictates that when a readmission is taken out of context, using this measure raises the potential conflict of interest between doing what is right for the patient and achieving a specific milestone that may not be in the best interest of an individual patient,” he said. “Discharging a patient early perhaps to the exclusion of adequately addressing inpatient issues for the purposes of achieving a target [length of stay] is perhaps the prime example of these conflicting interests.”
Because of the difficult recovery course after esophagectomy, some readmissions are “necessary, beneficial and, unequivocally, the right decision,” Dr. Kim said. “Ironically, one of the unintended consequences of this article may be that it exposes the fact that until a better system of recording and scrutinizing readmissions exists, governing organizations should exercise considerable caution when assessing a surgeon, hospital, or system and their readmissions,” he said.
To paraphrase the sociologist Robert K. Merton, who devised the law of unintended consequences, the existing state of knowledge limits one’s ability to anticipate the consequences of action. The authors of this study “have added immensely to a body of knowledge that is still growing and deserves ongoing study if policy is to be based upon it,” Dr. Kim said.
Dr. Kim had no disclosures.
About one in five patients who have surgery to remove part or all of the esophagus return to the hospital for complications within 30 days, and when they do their chance of death increases fivefold, compared with those who don’t return to the hospital, investigators at the University of Virginia Health System reported in the Journal of Thoracic and Cardiovascular Surgery (2015;150:1254-60).
“Early recognition of life-threatening readmission diagnoses is essential in order to provide optimal care,” said lead author Dr. Yinin Hu and colleagues. Esophageal cancer is the fastest-growing cancer in the United States, so the study investigators set out to closely examine the reasons for readmissions and death after surgery.
The study identified 1,688 patients in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database aged 66 or older who had surgery for esophageal cancer from 2000 to 2009. The overall 30-day mortality was 6.9%, and the 90-day mortality was 13.9%.
After excluding in-hospital deaths, the investigators’ readmission analysis included 1,543 patients. In this group, overall 90-day mortality following discharge was 6.4%, and the readmission rate within 30 days of discharge was 20.7%
The 90-day mortality for patients who were readmitted was more than four times that for those who were not readmitted, 16.3% vs. 3.8%; their in-hospital mortality was 8.8%. About one-third of readmissions were to facilities different from where patients had the index esophagectomy, and those patients were about seven times more likely to be transferred after readmission than patients admitted to the same facility, 15% vs. 1.9%. Risk-adjusted mortality did not vary significantly across providers.
The most frequent reasons for readmission were pneumonia (11.8%), malnutrition/dehydration (8.1%), pleural effusion (97.5%), and aspiration pneumonitis (6.8%). “Notably, more than one in five patients readmitted with a pulmonary diagnosis subsequently died within 90 days of the operation,” Dr. Hu and coauthors said, indicating that readmissions for pulmonary complications carried the worst prognosis.
This is the first study to demonstrate the gravity of pulmonary readmissions within 30 days of discharge, Dr. Hu and coauthors said. “Patients with nonspecific dyspneic symptoms or small pleural effusions should receive aggressive care upon readmission, as more than 20% will not survive the next few months,” Dr. Hu and coauthors said. “These results reinforce the notion that a fairly benign readmitting diagnosis is often an indicator of a much more severe root process.”
Among nonpulmonary reasons for readmission, dehydration and malnutrition carried the highest risk for death. “While there are many interventions that can promote postoperative nutrition, a readmission due to poor dietary tolerance often indicates other complications such as infection, stenosis, or anastomotic leak,” Dr. Hu and coauthors said. They suggested a thorough root-cause analysis should be part of every readmission.
The study also analyzed the hospital length of stay (LOS) as a predictor for readmission. The median LOS was 13 days, but the most common LOS was 9 days. “In general, the probability of readmission increases with increasing postoperative LOS,” Dr. Hu and colleagues said.
The authors reported no disclosures. Dr. Yinin Hu received funding from the National Institutes of Health and coauthor Dr. Benjamin Kozower received funding from the Agency for Healthcare Research and Quality.
About one in five patients who have surgery to remove part or all of the esophagus return to the hospital for complications within 30 days, and when they do their chance of death increases fivefold, compared with those who don’t return to the hospital, investigators at the University of Virginia Health System reported in the Journal of Thoracic and Cardiovascular Surgery (2015;150:1254-60).
“Early recognition of life-threatening readmission diagnoses is essential in order to provide optimal care,” said lead author Dr. Yinin Hu and colleagues. Esophageal cancer is the fastest-growing cancer in the United States, so the study investigators set out to closely examine the reasons for readmissions and death after surgery.
The study identified 1,688 patients in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database aged 66 or older who had surgery for esophageal cancer from 2000 to 2009. The overall 30-day mortality was 6.9%, and the 90-day mortality was 13.9%.
After excluding in-hospital deaths, the investigators’ readmission analysis included 1,543 patients. In this group, overall 90-day mortality following discharge was 6.4%, and the readmission rate within 30 days of discharge was 20.7%
The 90-day mortality for patients who were readmitted was more than four times that for those who were not readmitted, 16.3% vs. 3.8%; their in-hospital mortality was 8.8%. About one-third of readmissions were to facilities different from where patients had the index esophagectomy, and those patients were about seven times more likely to be transferred after readmission than patients admitted to the same facility, 15% vs. 1.9%. Risk-adjusted mortality did not vary significantly across providers.
The most frequent reasons for readmission were pneumonia (11.8%), malnutrition/dehydration (8.1%), pleural effusion (97.5%), and aspiration pneumonitis (6.8%). “Notably, more than one in five patients readmitted with a pulmonary diagnosis subsequently died within 90 days of the operation,” Dr. Hu and coauthors said, indicating that readmissions for pulmonary complications carried the worst prognosis.
This is the first study to demonstrate the gravity of pulmonary readmissions within 30 days of discharge, Dr. Hu and coauthors said. “Patients with nonspecific dyspneic symptoms or small pleural effusions should receive aggressive care upon readmission, as more than 20% will not survive the next few months,” Dr. Hu and coauthors said. “These results reinforce the notion that a fairly benign readmitting diagnosis is often an indicator of a much more severe root process.”
Among nonpulmonary reasons for readmission, dehydration and malnutrition carried the highest risk for death. “While there are many interventions that can promote postoperative nutrition, a readmission due to poor dietary tolerance often indicates other complications such as infection, stenosis, or anastomotic leak,” Dr. Hu and coauthors said. They suggested a thorough root-cause analysis should be part of every readmission.
The study also analyzed the hospital length of stay (LOS) as a predictor for readmission. The median LOS was 13 days, but the most common LOS was 9 days. “In general, the probability of readmission increases with increasing postoperative LOS,” Dr. Hu and colleagues said.
The authors reported no disclosures. Dr. Yinin Hu received funding from the National Institutes of Health and coauthor Dr. Benjamin Kozower received funding from the Agency for Healthcare Research and Quality.
Key clinical point: Patients readmitted after esophagectomy are at a greater than fourfold higher risk of death than patients who do not need readmission.
Major finding: The 90-day mortality for patients who were readmitted was greater than four times that for those who were not readmitted, 16.3% vs. 3.8%.
Data source: Analysis of 1,688 patients in the SEER-Medicare database aged 66 or older who had surgery for esophageal cancer from 2000 to 2009.
Disclosures: The authors had no disclosures. Lead author Dr. Yinin Hu received funding from the National Institutes of Health and coauthor Dr. Benjamin Kozower received funding from the Agency for Healthcare Research and Quality.
Does position matter in ViV implantation?
With transcatheter valve-in-valve implantation emerging as a novel treatment for high-risk patients whose existing bioprostheses have deteriorated, a team of investigators at University Heart Center in Hamburg, Germany, has found that the procedure can be done successfully in four different anatomic positions with a variety of bioprostheses.
The findings from the single-center study were published in the December issue of the Journal of Thoracic and Cardiovascular Surgery. (J Thorac Cardiovasc Surg. 2015;150:1557-67). They retrospectively analyzed results of 75 patients who had transcatheter valve-in-valve (ViV) replacement at their institution from 2008 to 2014.
“ViV can be performed in all anatomic positions with acceptable hemodynamic and clinical outcome in high-risk patients,” wrote Dr. Lenard Conradi and coauthors. “Increasing importance of ViV can be anticipated considering growing use of surgical bioprostheses.”
Replacement of biological valves is becoming more common. For surgical aortic valve replacement (SAVR), biological procedures have largely replaced mechanical valve implantation, comprising 87% of all such procedures by 2014, according to data from the German Society for Thoracic and Cardiovascular Surgery (Thorac Cardiovasc Surg. 2014;62:380-92). “Therefore, increasing caseload of patients with deteriorated bioprostheses can be expected,” wrote Dr. Conradi and coauthors.
The four anatomic positions in which the investigators performed the procedures and their share of cases are: aortic (54 patients/72%), mitral (17/22.7%), and tricuspid and pulmonary positions (2/2.7% each). The average interval between the index procedure and ViV was 9 years, with a deviation of nearly 5 years among all procedures. Dr. Conradi and coinvestigators said their study focused on technical aspects of ViV procedures from each position to provide guidance for surgeons.
Overall, the study authors performed ViV successfully in 97.3% of patients, with two patients requiring sequential transcatheter heart valve implantation for initial malpositioning. Thirty-day mortality was 8%, which “ranged lower” than expected when compared to standard preoperative risk stratification, they wrote. Mortality was at 5.6% in the aortic group and 17.6% in the mitral group.
That none of the currently available surgical bioprostheses or transcatheter heart valves (THV) were designed for later ViV procedures in deteriorated bioprostheses – although the CoreValve and Sapein THV have approvals for the indication – “may explain some of the apparent shortcomings of ViV therapy,” the researchers wrote.
The most significant challenge of ViV therapy is dealing with elevated residual gradients, which positioning can influence, according to the study findings. “This is not so much an issue for mitral, tricuspid, or pulmonary positions since surgical bioprostheses implanted in these positions are usually of sufficient size to accommodate the THV,” the researchers noted. “However, in the aortic position, more severe spatial restrictions may apply.”
They cited other reports that described a reverse relationship between size of the bioprosthetic and resulting transvalvular gradient after ViV (JACC Cardiovasc Interv. 2011;4:1218-27; JAMA 2014;312:162-70).
To reduce gradients, the investigators used post-ballooning after aortic ViV with a self-expandable THV in 16 cases, succeeding in 12. “Likely, further THV expansion with active compression of soft leaflet and/or pannus tissue and tighter apposition of THV against the frames of surgical bioprostheses contributed to this desired effect,” wrote the researchers. Patient-prosthesis mismatch probably explained the four cases in which gradients could not be further reduced, they noted.
They issued one “word of caution” regarding aortic ViV in small-sized surgical bioprostheses: “Elevated postprocedural gradients have to be expected and must be weighed against expected benefits and against risk of repeat open heart surgery.”
The six transcatheter heart valves the investigators used were Edwards Sapien (XT)/Sapien3 (52%, 39/75); Medtronic CoreValve/CoreValveEvolut (34.7%, 26); St. Jude Portico and Boston Scientific Lotus (4%, three each); and JenaValve and Medtronic Engager (2.7%, two each). The study also looked at different access routes: transapical in 53.3% (40), transfemoral (transarterial or transvenous) in 42.7% (32), transaortic in 2.7% (2), and transjugular in 1.3% (1).
Dr. Conradi and coauthors Dr. Moritz Seiffert, Dr. Ulrich Schaefer, and Dr. Hendrik Treede disclosed ties with Edwards Lifesciences, JenaValve Technology, Medtronic, Symetis, and St. Jude Medical. Four other coauthors reported no disclosures.
As the population ages and younger patients choose bioprosthetic valves to avoid lifelong warfarin, surgeons are going to face more situations where they will have to decide whether to perform surgical or transcatheter reoperative valve surgery, Dr. Jessica Forcillo of Emory University, Atlanta, and coauthors wrote in an invited commentary (J Thorac Cardiovasc Surg. 2015;150:1568-9).
They called the 8% 30-day mortality rate in the Hamburg study “high” even though the average age of the study population was a “relatively young” 74 years. The Hamburg authors may have learned more had they evaluated fewer prostheses. “With a small number of patients and at the beginning of an experience, focusing on one or two available prostheses may have resulted in more accurate and reliable results,” noted Dr. Forcillo and her colleagues. That 53% of the procedures were done via the transapical approach may also explain the mortality rate, they said.
The overall 30-day mortality rate along with a 17.6% mortality in the mitral ViV group are causes for “some caution against overzealous performance of this procedure and continued monitoring of outcomes in other series,” wrote Dr. Forcillo and her colleagues.
But ViV implantation is a “transformative” technology, they said. “For the elderly, high-risk patients with [structural valve degeneration], transcatheter options may provide improved short-term outcomes,” they added. “The valve community eagerly awaits larger series with adjudicated outcomes of the transcatheter valve-in-valve procedure.”
Dr. Forcillo and coauthor Lillian Tsai had no disclosures. Dr. Vinod Thourani disclosed ties with St. Jude Medical, Edwards Lifesciences, Boston Scientific, Abbott Medical, Medtronic, Directflow, and Sorin Medical.
As the population ages and younger patients choose bioprosthetic valves to avoid lifelong warfarin, surgeons are going to face more situations where they will have to decide whether to perform surgical or transcatheter reoperative valve surgery, Dr. Jessica Forcillo of Emory University, Atlanta, and coauthors wrote in an invited commentary (J Thorac Cardiovasc Surg. 2015;150:1568-9).
They called the 8% 30-day mortality rate in the Hamburg study “high” even though the average age of the study population was a “relatively young” 74 years. The Hamburg authors may have learned more had they evaluated fewer prostheses. “With a small number of patients and at the beginning of an experience, focusing on one or two available prostheses may have resulted in more accurate and reliable results,” noted Dr. Forcillo and her colleagues. That 53% of the procedures were done via the transapical approach may also explain the mortality rate, they said.
The overall 30-day mortality rate along with a 17.6% mortality in the mitral ViV group are causes for “some caution against overzealous performance of this procedure and continued monitoring of outcomes in other series,” wrote Dr. Forcillo and her colleagues.
But ViV implantation is a “transformative” technology, they said. “For the elderly, high-risk patients with [structural valve degeneration], transcatheter options may provide improved short-term outcomes,” they added. “The valve community eagerly awaits larger series with adjudicated outcomes of the transcatheter valve-in-valve procedure.”
Dr. Forcillo and coauthor Lillian Tsai had no disclosures. Dr. Vinod Thourani disclosed ties with St. Jude Medical, Edwards Lifesciences, Boston Scientific, Abbott Medical, Medtronic, Directflow, and Sorin Medical.
As the population ages and younger patients choose bioprosthetic valves to avoid lifelong warfarin, surgeons are going to face more situations where they will have to decide whether to perform surgical or transcatheter reoperative valve surgery, Dr. Jessica Forcillo of Emory University, Atlanta, and coauthors wrote in an invited commentary (J Thorac Cardiovasc Surg. 2015;150:1568-9).
They called the 8% 30-day mortality rate in the Hamburg study “high” even though the average age of the study population was a “relatively young” 74 years. The Hamburg authors may have learned more had they evaluated fewer prostheses. “With a small number of patients and at the beginning of an experience, focusing on one or two available prostheses may have resulted in more accurate and reliable results,” noted Dr. Forcillo and her colleagues. That 53% of the procedures were done via the transapical approach may also explain the mortality rate, they said.
The overall 30-day mortality rate along with a 17.6% mortality in the mitral ViV group are causes for “some caution against overzealous performance of this procedure and continued monitoring of outcomes in other series,” wrote Dr. Forcillo and her colleagues.
But ViV implantation is a “transformative” technology, they said. “For the elderly, high-risk patients with [structural valve degeneration], transcatheter options may provide improved short-term outcomes,” they added. “The valve community eagerly awaits larger series with adjudicated outcomes of the transcatheter valve-in-valve procedure.”
Dr. Forcillo and coauthor Lillian Tsai had no disclosures. Dr. Vinod Thourani disclosed ties with St. Jude Medical, Edwards Lifesciences, Boston Scientific, Abbott Medical, Medtronic, Directflow, and Sorin Medical.
With transcatheter valve-in-valve implantation emerging as a novel treatment for high-risk patients whose existing bioprostheses have deteriorated, a team of investigators at University Heart Center in Hamburg, Germany, has found that the procedure can be done successfully in four different anatomic positions with a variety of bioprostheses.
The findings from the single-center study were published in the December issue of the Journal of Thoracic and Cardiovascular Surgery. (J Thorac Cardiovasc Surg. 2015;150:1557-67). They retrospectively analyzed results of 75 patients who had transcatheter valve-in-valve (ViV) replacement at their institution from 2008 to 2014.
“ViV can be performed in all anatomic positions with acceptable hemodynamic and clinical outcome in high-risk patients,” wrote Dr. Lenard Conradi and coauthors. “Increasing importance of ViV can be anticipated considering growing use of surgical bioprostheses.”
Replacement of biological valves is becoming more common. For surgical aortic valve replacement (SAVR), biological procedures have largely replaced mechanical valve implantation, comprising 87% of all such procedures by 2014, according to data from the German Society for Thoracic and Cardiovascular Surgery (Thorac Cardiovasc Surg. 2014;62:380-92). “Therefore, increasing caseload of patients with deteriorated bioprostheses can be expected,” wrote Dr. Conradi and coauthors.
The four anatomic positions in which the investigators performed the procedures and their share of cases are: aortic (54 patients/72%), mitral (17/22.7%), and tricuspid and pulmonary positions (2/2.7% each). The average interval between the index procedure and ViV was 9 years, with a deviation of nearly 5 years among all procedures. Dr. Conradi and coinvestigators said their study focused on technical aspects of ViV procedures from each position to provide guidance for surgeons.
Overall, the study authors performed ViV successfully in 97.3% of patients, with two patients requiring sequential transcatheter heart valve implantation for initial malpositioning. Thirty-day mortality was 8%, which “ranged lower” than expected when compared to standard preoperative risk stratification, they wrote. Mortality was at 5.6% in the aortic group and 17.6% in the mitral group.
That none of the currently available surgical bioprostheses or transcatheter heart valves (THV) were designed for later ViV procedures in deteriorated bioprostheses – although the CoreValve and Sapein THV have approvals for the indication – “may explain some of the apparent shortcomings of ViV therapy,” the researchers wrote.
The most significant challenge of ViV therapy is dealing with elevated residual gradients, which positioning can influence, according to the study findings. “This is not so much an issue for mitral, tricuspid, or pulmonary positions since surgical bioprostheses implanted in these positions are usually of sufficient size to accommodate the THV,” the researchers noted. “However, in the aortic position, more severe spatial restrictions may apply.”
They cited other reports that described a reverse relationship between size of the bioprosthetic and resulting transvalvular gradient after ViV (JACC Cardiovasc Interv. 2011;4:1218-27; JAMA 2014;312:162-70).
To reduce gradients, the investigators used post-ballooning after aortic ViV with a self-expandable THV in 16 cases, succeeding in 12. “Likely, further THV expansion with active compression of soft leaflet and/or pannus tissue and tighter apposition of THV against the frames of surgical bioprostheses contributed to this desired effect,” wrote the researchers. Patient-prosthesis mismatch probably explained the four cases in which gradients could not be further reduced, they noted.
They issued one “word of caution” regarding aortic ViV in small-sized surgical bioprostheses: “Elevated postprocedural gradients have to be expected and must be weighed against expected benefits and against risk of repeat open heart surgery.”
The six transcatheter heart valves the investigators used were Edwards Sapien (XT)/Sapien3 (52%, 39/75); Medtronic CoreValve/CoreValveEvolut (34.7%, 26); St. Jude Portico and Boston Scientific Lotus (4%, three each); and JenaValve and Medtronic Engager (2.7%, two each). The study also looked at different access routes: transapical in 53.3% (40), transfemoral (transarterial or transvenous) in 42.7% (32), transaortic in 2.7% (2), and transjugular in 1.3% (1).
Dr. Conradi and coauthors Dr. Moritz Seiffert, Dr. Ulrich Schaefer, and Dr. Hendrik Treede disclosed ties with Edwards Lifesciences, JenaValve Technology, Medtronic, Symetis, and St. Jude Medical. Four other coauthors reported no disclosures.
With transcatheter valve-in-valve implantation emerging as a novel treatment for high-risk patients whose existing bioprostheses have deteriorated, a team of investigators at University Heart Center in Hamburg, Germany, has found that the procedure can be done successfully in four different anatomic positions with a variety of bioprostheses.
The findings from the single-center study were published in the December issue of the Journal of Thoracic and Cardiovascular Surgery. (J Thorac Cardiovasc Surg. 2015;150:1557-67). They retrospectively analyzed results of 75 patients who had transcatheter valve-in-valve (ViV) replacement at their institution from 2008 to 2014.
“ViV can be performed in all anatomic positions with acceptable hemodynamic and clinical outcome in high-risk patients,” wrote Dr. Lenard Conradi and coauthors. “Increasing importance of ViV can be anticipated considering growing use of surgical bioprostheses.”
Replacement of biological valves is becoming more common. For surgical aortic valve replacement (SAVR), biological procedures have largely replaced mechanical valve implantation, comprising 87% of all such procedures by 2014, according to data from the German Society for Thoracic and Cardiovascular Surgery (Thorac Cardiovasc Surg. 2014;62:380-92). “Therefore, increasing caseload of patients with deteriorated bioprostheses can be expected,” wrote Dr. Conradi and coauthors.
The four anatomic positions in which the investigators performed the procedures and their share of cases are: aortic (54 patients/72%), mitral (17/22.7%), and tricuspid and pulmonary positions (2/2.7% each). The average interval between the index procedure and ViV was 9 years, with a deviation of nearly 5 years among all procedures. Dr. Conradi and coinvestigators said their study focused on technical aspects of ViV procedures from each position to provide guidance for surgeons.
Overall, the study authors performed ViV successfully in 97.3% of patients, with two patients requiring sequential transcatheter heart valve implantation for initial malpositioning. Thirty-day mortality was 8%, which “ranged lower” than expected when compared to standard preoperative risk stratification, they wrote. Mortality was at 5.6% in the aortic group and 17.6% in the mitral group.
That none of the currently available surgical bioprostheses or transcatheter heart valves (THV) were designed for later ViV procedures in deteriorated bioprostheses – although the CoreValve and Sapein THV have approvals for the indication – “may explain some of the apparent shortcomings of ViV therapy,” the researchers wrote.
The most significant challenge of ViV therapy is dealing with elevated residual gradients, which positioning can influence, according to the study findings. “This is not so much an issue for mitral, tricuspid, or pulmonary positions since surgical bioprostheses implanted in these positions are usually of sufficient size to accommodate the THV,” the researchers noted. “However, in the aortic position, more severe spatial restrictions may apply.”
They cited other reports that described a reverse relationship between size of the bioprosthetic and resulting transvalvular gradient after ViV (JACC Cardiovasc Interv. 2011;4:1218-27; JAMA 2014;312:162-70).
To reduce gradients, the investigators used post-ballooning after aortic ViV with a self-expandable THV in 16 cases, succeeding in 12. “Likely, further THV expansion with active compression of soft leaflet and/or pannus tissue and tighter apposition of THV against the frames of surgical bioprostheses contributed to this desired effect,” wrote the researchers. Patient-prosthesis mismatch probably explained the four cases in which gradients could not be further reduced, they noted.
They issued one “word of caution” regarding aortic ViV in small-sized surgical bioprostheses: “Elevated postprocedural gradients have to be expected and must be weighed against expected benefits and against risk of repeat open heart surgery.”
The six transcatheter heart valves the investigators used were Edwards Sapien (XT)/Sapien3 (52%, 39/75); Medtronic CoreValve/CoreValveEvolut (34.7%, 26); St. Jude Portico and Boston Scientific Lotus (4%, three each); and JenaValve and Medtronic Engager (2.7%, two each). The study also looked at different access routes: transapical in 53.3% (40), transfemoral (transarterial or transvenous) in 42.7% (32), transaortic in 2.7% (2), and transjugular in 1.3% (1).
Dr. Conradi and coauthors Dr. Moritz Seiffert, Dr. Ulrich Schaefer, and Dr. Hendrik Treede disclosed ties with Edwards Lifesciences, JenaValve Technology, Medtronic, Symetis, and St. Jude Medical. Four other coauthors reported no disclosures.
Key clinical point: Transcatheter valve-in-valve (ViV) implantation is a relatively safe treatment for patients with a deteriorated bioprostheses.
Major finding: A ViV implantation when performed in four different positions with six different transcatheter heart valves had a 30-day mortality of 8%.
Data source: Retrospective analysis of 75 consecutive patients receiving ViV procedures from 2008 to 2014 at a single institution.
Disclosures: Dr. Conradi and coauthors Dr. Moritz Seiffert, Dr. Ulrich Schaefer, and Dr. Hendrik Treede disclosed relationships with Edwards Lifesciences, JenaValve Technology, Medtronic, Symetis, and St. Jude Medical. Four other coauthors reported no disclosures.
Surgical ablation endures at 5 years
The Cox-Maze IV procedure (CMPIV) has become the standard for surgical ablation for atrial fibrillation (AF), yet little information has been available on how late outcomes compare with catheter-based ablation. A recent analysis of 576 procedures found that after 5 years, most people who had the procedure remained free of atrial tachyarrhythmias and anticoagulation.
The study, by investigators from Washington University, Barnes-Jewish Hospital in St. Louis, was published in the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2015;150:1168-78). The researchers first presented the study in April at the American Association for Thoracic Surgery meeting in Seattle.
“The results of the CMPIV remain superior to those reported for catheter ablation and other forms of surgical AF ablation, especially for patients with persistent or long-standing AF,” wrote Dr. Matthew C. Henn and his colleagues.
They set out to evaluate late outcomes after CMPIV using current consensus definitions of treatment failure, noting that such outcomes had yet to be reported. They followed 576 patients with atrial fibrillation who had a CMPIV from 2002 to 2014 and compared long-term freedom from atrial fibrillation on and off antiarrhythmic drugs (AADs) across various subgroups. They included the left-sided CMPIV lesion in the analysis because, they said, it had success rates similar to those of biatrial CMPIV.
The Cox-Maze procedure was first introduced by Dr. James Cox in 1987 and updated from the original “cut-and-sew” technique in 2002 to combine bipolar radiofrequency and cryothermal ablation lines in place of most surgical incisions. This iteration was called the Cox-Maze IV procedure. In 2005, CMPIV was modified to include a superior connecting lesion, which formed a “box lesion” by completely isolating the entire posterior left atrium. The study included 512 people who underwent the “box lesion” set procedure.
“The modifications of the CMPIV have allowed it to be performed through a right minithoracotomy (RMT) approach, which has further reduced major morbidity, mortality, and hospital stay compared to those who underwent sternotomy while enjoying equivalent outcomes with regards to freedom from AF,” wrote Dr. Henn and his coauthors.
In the entire cohort, the overall freedom from atrial tachyarrhythmias (ATAs) and anticoagulation were 92% at 1 year, 88% at 2 years, 87% at 3 years, 81% at 4 years, and 73% at 5 years. Overall freedom from ATAs off antiarrhythmic drugs for the entire cohort ranged from 81% at 1 year to 61% at 5 years, and freedom from anticoagulation ranged from 65% at 1 year to 55% at 5 years.
“Freedoms from ATAs on or off AADs were significantly higher in those who underwent box lesion sets when compared to those who did not at 5 years,” noted Dr. Henn and his coauthors. Among the box lesion set group, 78% of those on AADs remained free of ATAs vs. 45% in the non–box lesion set group, and for those off AADs, 66% had no ATAs at 5 years while 33% of the non–box lesion set group did.
Of the overall study population, 41% had paroxysmal AF and 58% had nonparoxysmal AF. Among the latter group, 20% had persistent and 80% had long-standing persistent AF. The nonparoxysmal AF group had a longer duration of preoperative AF, larger left atria and more failed catheter ablations, Dr. Henn and coauthors reported. But, the study showed no differences in freedom from atrial fibrillation on or off AADs at 5 years between patients with paroxysmal AF or persistent/long-standing persistent AF, or between those who underwent stand-alone procedure and those who received a concomitant Cox-Maze procedure. Among those who had a concomitant procedure, 50% had a concomitant mitral valve procedure and 23% had coronary artery bypass grafting.
“The CMPIV results in our series were better than what has been achieved with catheter ablation,” the researchers wrote. They cited studies that showed arrhythmia-free survival after a single ablation procedure ranging from 17% to 29% and “equally poor results.” (Circ Arrhythm Electrophysiol. 2015;8:18-24; J Am Coll Cardiol. 2011;57:160-166; J Am Heart Assoc. 2013;2:e004549.)
“The CMPIV remains the most successful surgical treatment for AF, even in patients with non-paroxysmal AF and regardless of the complexity of the concomitant procedures,” Dr. Henn and his coauthors concluded.
Inconsistencies in this study of the Cox-Maze IV procedure include differing types of atrial fibrillation, heterogeneous concomitant operations, multiple lesion sets and energy sources and inconsistent postablation monitoring, all of which make direct comparisons of surgical ablation strategies or even catheter ablation difficult, Dr. Robert Hawkins and Dr. Gorav Ailawadi of the University of Virginia noted in their invited commentary (J Thorac Cardiovasc Surg. 2015;150:1179-80). “Moreover, without controls or selection criteria, it is difficult to account for selection bias,” they wrote.
Yet, this study has “some important findings” despite its shortcomings, namely the “respectable” rates of atrial tachyarrhythmias off antiarrhythmic drugs. These results are superior to other clinical trials, “in part due to the expertise at Washington University,” noted Dr. Hawkins and Dr. Ailawadi.
Adding patients who had the box lesion set approach also improved 5-year outcomes in the study substantially, and left atrium (LA) ablation alone has good results in patients with paroxysmal AF, left atria less than 5.0 cm, and no right atrial enlargement. “Yet, a direct comparison between biatrial and LA lesion sets cannot be made due to the above listed limitations,” they wrote.
The study makes a case for surgical ablation when the preoperative duration of AF is less than 5-10 years and left atrium size is not a problem, and the lesion-set requires further investigation, they said. “Finally, this study highlights the continued need for rigorous monitoring and comparisons of homogeneous patient populations to make stronger conclusions.”
Dr. Ailawadi disclosed relationships with Abbot Vascular, Mitralign, Edwards Lifesciences and St. Jude Medical. Dr. Hawkins had no relationships to disclose.
Inconsistencies in this study of the Cox-Maze IV procedure include differing types of atrial fibrillation, heterogeneous concomitant operations, multiple lesion sets and energy sources and inconsistent postablation monitoring, all of which make direct comparisons of surgical ablation strategies or even catheter ablation difficult, Dr. Robert Hawkins and Dr. Gorav Ailawadi of the University of Virginia noted in their invited commentary (J Thorac Cardiovasc Surg. 2015;150:1179-80). “Moreover, without controls or selection criteria, it is difficult to account for selection bias,” they wrote.
Yet, this study has “some important findings” despite its shortcomings, namely the “respectable” rates of atrial tachyarrhythmias off antiarrhythmic drugs. These results are superior to other clinical trials, “in part due to the expertise at Washington University,” noted Dr. Hawkins and Dr. Ailawadi.
Adding patients who had the box lesion set approach also improved 5-year outcomes in the study substantially, and left atrium (LA) ablation alone has good results in patients with paroxysmal AF, left atria less than 5.0 cm, and no right atrial enlargement. “Yet, a direct comparison between biatrial and LA lesion sets cannot be made due to the above listed limitations,” they wrote.
The study makes a case for surgical ablation when the preoperative duration of AF is less than 5-10 years and left atrium size is not a problem, and the lesion-set requires further investigation, they said. “Finally, this study highlights the continued need for rigorous monitoring and comparisons of homogeneous patient populations to make stronger conclusions.”
Dr. Ailawadi disclosed relationships with Abbot Vascular, Mitralign, Edwards Lifesciences and St. Jude Medical. Dr. Hawkins had no relationships to disclose.
Inconsistencies in this study of the Cox-Maze IV procedure include differing types of atrial fibrillation, heterogeneous concomitant operations, multiple lesion sets and energy sources and inconsistent postablation monitoring, all of which make direct comparisons of surgical ablation strategies or even catheter ablation difficult, Dr. Robert Hawkins and Dr. Gorav Ailawadi of the University of Virginia noted in their invited commentary (J Thorac Cardiovasc Surg. 2015;150:1179-80). “Moreover, without controls or selection criteria, it is difficult to account for selection bias,” they wrote.
Yet, this study has “some important findings” despite its shortcomings, namely the “respectable” rates of atrial tachyarrhythmias off antiarrhythmic drugs. These results are superior to other clinical trials, “in part due to the expertise at Washington University,” noted Dr. Hawkins and Dr. Ailawadi.
Adding patients who had the box lesion set approach also improved 5-year outcomes in the study substantially, and left atrium (LA) ablation alone has good results in patients with paroxysmal AF, left atria less than 5.0 cm, and no right atrial enlargement. “Yet, a direct comparison between biatrial and LA lesion sets cannot be made due to the above listed limitations,” they wrote.
The study makes a case for surgical ablation when the preoperative duration of AF is less than 5-10 years and left atrium size is not a problem, and the lesion-set requires further investigation, they said. “Finally, this study highlights the continued need for rigorous monitoring and comparisons of homogeneous patient populations to make stronger conclusions.”
Dr. Ailawadi disclosed relationships with Abbot Vascular, Mitralign, Edwards Lifesciences and St. Jude Medical. Dr. Hawkins had no relationships to disclose.
The Cox-Maze IV procedure (CMPIV) has become the standard for surgical ablation for atrial fibrillation (AF), yet little information has been available on how late outcomes compare with catheter-based ablation. A recent analysis of 576 procedures found that after 5 years, most people who had the procedure remained free of atrial tachyarrhythmias and anticoagulation.
The study, by investigators from Washington University, Barnes-Jewish Hospital in St. Louis, was published in the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2015;150:1168-78). The researchers first presented the study in April at the American Association for Thoracic Surgery meeting in Seattle.
“The results of the CMPIV remain superior to those reported for catheter ablation and other forms of surgical AF ablation, especially for patients with persistent or long-standing AF,” wrote Dr. Matthew C. Henn and his colleagues.
They set out to evaluate late outcomes after CMPIV using current consensus definitions of treatment failure, noting that such outcomes had yet to be reported. They followed 576 patients with atrial fibrillation who had a CMPIV from 2002 to 2014 and compared long-term freedom from atrial fibrillation on and off antiarrhythmic drugs (AADs) across various subgroups. They included the left-sided CMPIV lesion in the analysis because, they said, it had success rates similar to those of biatrial CMPIV.
The Cox-Maze procedure was first introduced by Dr. James Cox in 1987 and updated from the original “cut-and-sew” technique in 2002 to combine bipolar radiofrequency and cryothermal ablation lines in place of most surgical incisions. This iteration was called the Cox-Maze IV procedure. In 2005, CMPIV was modified to include a superior connecting lesion, which formed a “box lesion” by completely isolating the entire posterior left atrium. The study included 512 people who underwent the “box lesion” set procedure.
“The modifications of the CMPIV have allowed it to be performed through a right minithoracotomy (RMT) approach, which has further reduced major morbidity, mortality, and hospital stay compared to those who underwent sternotomy while enjoying equivalent outcomes with regards to freedom from AF,” wrote Dr. Henn and his coauthors.
In the entire cohort, the overall freedom from atrial tachyarrhythmias (ATAs) and anticoagulation were 92% at 1 year, 88% at 2 years, 87% at 3 years, 81% at 4 years, and 73% at 5 years. Overall freedom from ATAs off antiarrhythmic drugs for the entire cohort ranged from 81% at 1 year to 61% at 5 years, and freedom from anticoagulation ranged from 65% at 1 year to 55% at 5 years.
“Freedoms from ATAs on or off AADs were significantly higher in those who underwent box lesion sets when compared to those who did not at 5 years,” noted Dr. Henn and his coauthors. Among the box lesion set group, 78% of those on AADs remained free of ATAs vs. 45% in the non–box lesion set group, and for those off AADs, 66% had no ATAs at 5 years while 33% of the non–box lesion set group did.
Of the overall study population, 41% had paroxysmal AF and 58% had nonparoxysmal AF. Among the latter group, 20% had persistent and 80% had long-standing persistent AF. The nonparoxysmal AF group had a longer duration of preoperative AF, larger left atria and more failed catheter ablations, Dr. Henn and coauthors reported. But, the study showed no differences in freedom from atrial fibrillation on or off AADs at 5 years between patients with paroxysmal AF or persistent/long-standing persistent AF, or between those who underwent stand-alone procedure and those who received a concomitant Cox-Maze procedure. Among those who had a concomitant procedure, 50% had a concomitant mitral valve procedure and 23% had coronary artery bypass grafting.
“The CMPIV results in our series were better than what has been achieved with catheter ablation,” the researchers wrote. They cited studies that showed arrhythmia-free survival after a single ablation procedure ranging from 17% to 29% and “equally poor results.” (Circ Arrhythm Electrophysiol. 2015;8:18-24; J Am Coll Cardiol. 2011;57:160-166; J Am Heart Assoc. 2013;2:e004549.)
“The CMPIV remains the most successful surgical treatment for AF, even in patients with non-paroxysmal AF and regardless of the complexity of the concomitant procedures,” Dr. Henn and his coauthors concluded.
The Cox-Maze IV procedure (CMPIV) has become the standard for surgical ablation for atrial fibrillation (AF), yet little information has been available on how late outcomes compare with catheter-based ablation. A recent analysis of 576 procedures found that after 5 years, most people who had the procedure remained free of atrial tachyarrhythmias and anticoagulation.
The study, by investigators from Washington University, Barnes-Jewish Hospital in St. Louis, was published in the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2015;150:1168-78). The researchers first presented the study in April at the American Association for Thoracic Surgery meeting in Seattle.
“The results of the CMPIV remain superior to those reported for catheter ablation and other forms of surgical AF ablation, especially for patients with persistent or long-standing AF,” wrote Dr. Matthew C. Henn and his colleagues.
They set out to evaluate late outcomes after CMPIV using current consensus definitions of treatment failure, noting that such outcomes had yet to be reported. They followed 576 patients with atrial fibrillation who had a CMPIV from 2002 to 2014 and compared long-term freedom from atrial fibrillation on and off antiarrhythmic drugs (AADs) across various subgroups. They included the left-sided CMPIV lesion in the analysis because, they said, it had success rates similar to those of biatrial CMPIV.
The Cox-Maze procedure was first introduced by Dr. James Cox in 1987 and updated from the original “cut-and-sew” technique in 2002 to combine bipolar radiofrequency and cryothermal ablation lines in place of most surgical incisions. This iteration was called the Cox-Maze IV procedure. In 2005, CMPIV was modified to include a superior connecting lesion, which formed a “box lesion” by completely isolating the entire posterior left atrium. The study included 512 people who underwent the “box lesion” set procedure.
“The modifications of the CMPIV have allowed it to be performed through a right minithoracotomy (RMT) approach, which has further reduced major morbidity, mortality, and hospital stay compared to those who underwent sternotomy while enjoying equivalent outcomes with regards to freedom from AF,” wrote Dr. Henn and his coauthors.
In the entire cohort, the overall freedom from atrial tachyarrhythmias (ATAs) and anticoagulation were 92% at 1 year, 88% at 2 years, 87% at 3 years, 81% at 4 years, and 73% at 5 years. Overall freedom from ATAs off antiarrhythmic drugs for the entire cohort ranged from 81% at 1 year to 61% at 5 years, and freedom from anticoagulation ranged from 65% at 1 year to 55% at 5 years.
“Freedoms from ATAs on or off AADs were significantly higher in those who underwent box lesion sets when compared to those who did not at 5 years,” noted Dr. Henn and his coauthors. Among the box lesion set group, 78% of those on AADs remained free of ATAs vs. 45% in the non–box lesion set group, and for those off AADs, 66% had no ATAs at 5 years while 33% of the non–box lesion set group did.
Of the overall study population, 41% had paroxysmal AF and 58% had nonparoxysmal AF. Among the latter group, 20% had persistent and 80% had long-standing persistent AF. The nonparoxysmal AF group had a longer duration of preoperative AF, larger left atria and more failed catheter ablations, Dr. Henn and coauthors reported. But, the study showed no differences in freedom from atrial fibrillation on or off AADs at 5 years between patients with paroxysmal AF or persistent/long-standing persistent AF, or between those who underwent stand-alone procedure and those who received a concomitant Cox-Maze procedure. Among those who had a concomitant procedure, 50% had a concomitant mitral valve procedure and 23% had coronary artery bypass grafting.
“The CMPIV results in our series were better than what has been achieved with catheter ablation,” the researchers wrote. They cited studies that showed arrhythmia-free survival after a single ablation procedure ranging from 17% to 29% and “equally poor results.” (Circ Arrhythm Electrophysiol. 2015;8:18-24; J Am Coll Cardiol. 2011;57:160-166; J Am Heart Assoc. 2013;2:e004549.)
“The CMPIV remains the most successful surgical treatment for AF, even in patients with non-paroxysmal AF and regardless of the complexity of the concomitant procedures,” Dr. Henn and his coauthors concluded.
Key clinical point: Outcomes with the Cox-Maze IV procedure for surgical ablation are superior to catheter ablation and other forms of surgical ablation for atrial fibrillation for up to 5 years duration.
Major finding: Seventy-three percent of the study population was free from atrial tachyarrhythmias and 55% were free from anticoagulation at 5 years.
Data source: Prospective analysis of 576 consecutive patients with atrial fibrillation who had Cox-Maze IV procedure or a left-sized Cox-Maze IV procedure from 2002 to 2014 at a single institution
Disclosures: The National Institutes of Health provided grants for the study. Coauthor Dr. Ralph J. Damiano Jr. disclosed research grants and educational funding from AtriCure and Edwards LifeSciences. The other authors had no disclosures.
Pediatric heart transplant results not improving
A 25-year study of heart transplants in children with congenital heart disease (CHD) at one institution has found that results haven’t improved over time despite advances in technology and techniques. To improve outcomes, transplant surgeons may need to do a better job of selecting patients and matching patients and donors, according to study in the December issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2015;150:1455-62).
“Strategies to improve outcomes in CHD patients might need to address selection criteria, transplantation timing, pretransplant and posttransplant care,” noted Dr. Bahaaldin Alsoufi, of the division of cardiothoracic surgery, Children’s Healthcare of Atlanta, Emory University. “The effect of donor/recipient race mismatch warrants further investigation and might impact organ allocation algorithms or immunosuppression management,” wrote Dr. Alsoufi and his colleagues.
The researchers analyzed results of 124 children with CHD who had heart transplants from 1988 to 2013 at Emory University and Children’s Healthcare of Atlanta. Median age was 3.8 years; 61% were boys. Ten years after heart transplantation, 44% (54) of patients were alive without a second transplant, 13% (17) had a second transplant and 43% (53) died without a second transplant. After the second transplant, 9 of the 17 patients were alive, but 3 of them had gone onto a third transplant. Overall 15-year survival following the first transplant was 41% (51).
The study cited data from the Registry of the International Society for Heart and Lung Transplantation that reported more than 11,000 pediatric heart transplants worldwide in 2013, and CHD represents about 54% of all heart transplants in infants.
A multivariate analysis identified the following risk factors for early mortality after transplant: age younger than 12 months (hazard ration [HR] 7.2) and prolonged cardiopulmonary bypass (HR 5). Late-phase mortality risk factors were age younger than 12 months (HR 3) and donor/recipient race mismatch (HR 2.2).
“Survival was not affected by era, underlying anomaly, prior Fontan, sensitization or pulmonary artery augmentation,” wrote Dr. Alsoufi and his colleagues.
Among the risk factors, longer bypass times may be a surrogate for a more complicated operation, the authors said. But where prior sternotomy is a risk factor following a heart transplant in adults, the study found no such risk in children. Another risk factor previous reports identified is pulmonary artery augmentation, but, again, this study found no risk in the pediatric group.
The researchers looked at days on the waiting list, with a median wait of 39 days in the study group. In all, 175 children were listed for transplants, but 51 did not go through for various reasons. Most of the children with CHD who had a heart transplant had previous surgery; only 13% had a primary heart transplant, mostly in the earlier phase of the study.
Dr. Alsoufi and coauthors also identified African American race as a risk factor for lower survival, which is consistent with other reports. But this study agreed with a previous report that donor/recipient race mismatch was a significant risk factor in white and African American patients (Ann Thorac Surg. 2009;87:204-9). “While our finding might be anecdotal and specific to our geographic population, this warrants some investigation and might have some impact on future organ allocation algorithms and immunosuppression management,” the researchers wrote.
The authors had no relevant disclosures. Emory University School of Medicine, Children’s Healthcare of Atlanta provided study funding.
In his invited commentary, Dr. Robert D.B. Jaquiss of Duke University, Durham, N.C., took issue with the study authors’ “distress” at the lack of improvement in survival over the 25-year term of the study (J Thorac Cardiovasc Surg. 2015;150:1463-4) . Using the year 2000 as a demarcation line for early and late-phase results, Dr. Jaquiss said, “It must be pointed out that in the latter period recipients were much more ill.” He noted that 89% of post-2000 heart transplant patients had UNOS status 1 vs. 49% in the pre-2000 period.
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Dr. Robert Jaquiss |
“Considering these between-era differences, an alternative, less ‘discouraging’ interpretation is that excellent outcomes were maintained despite the trend toward transplantation in sicker patients, undergoing more complex transplants, with longer ischemic times,” he said.
Dr. Jaquiss also cited “remarkably outstanding outcomes” in Fontan patients, reporting only one operative death in 33 patients. He found the lower survival for African-American patients in the study group “more sobering,” but also controversial because, among other reasons, “a complete mechanistic explanation remains elusive.” How these findings influence pediatric heart transplant practice “requires thoughtful and extensive investigation and discussion,” he said.
Wait-list mortality and mechanical bridge to transplant also deserve mention, he noted. “Though they are only briefly mentioned, the patients who died prior to transplant provide mute testimony to the lack of timely access to suitable donors,” Dr. Jaquiss said. Durable mechanical circulatory support can provide a bridge for these patients, but was not available through the majority of the study period.
“It is striking that no patient in this report was supported by a ventricular assist device (VAD), and only a small number (5%) had been on [extracorporeal membrane oxygenation] support,” Dr. Jaquiss said. “This is an unfortunate and unavoidable weakness of this report, given the recent introduction of VADs for pediatric heart transplant candidates.” The use of VAD in patients with CHD is “increasing rapidly,” he said.
Dr. Jaquiss had no disclosures.
In his invited commentary, Dr. Robert D.B. Jaquiss of Duke University, Durham, N.C., took issue with the study authors’ “distress” at the lack of improvement in survival over the 25-year term of the study (J Thorac Cardiovasc Surg. 2015;150:1463-4) . Using the year 2000 as a demarcation line for early and late-phase results, Dr. Jaquiss said, “It must be pointed out that in the latter period recipients were much more ill.” He noted that 89% of post-2000 heart transplant patients had UNOS status 1 vs. 49% in the pre-2000 period.
|
|
Dr. Robert Jaquiss |
“Considering these between-era differences, an alternative, less ‘discouraging’ interpretation is that excellent outcomes were maintained despite the trend toward transplantation in sicker patients, undergoing more complex transplants, with longer ischemic times,” he said.
Dr. Jaquiss also cited “remarkably outstanding outcomes” in Fontan patients, reporting only one operative death in 33 patients. He found the lower survival for African-American patients in the study group “more sobering,” but also controversial because, among other reasons, “a complete mechanistic explanation remains elusive.” How these findings influence pediatric heart transplant practice “requires thoughtful and extensive investigation and discussion,” he said.
Wait-list mortality and mechanical bridge to transplant also deserve mention, he noted. “Though they are only briefly mentioned, the patients who died prior to transplant provide mute testimony to the lack of timely access to suitable donors,” Dr. Jaquiss said. Durable mechanical circulatory support can provide a bridge for these patients, but was not available through the majority of the study period.
“It is striking that no patient in this report was supported by a ventricular assist device (VAD), and only a small number (5%) had been on [extracorporeal membrane oxygenation] support,” Dr. Jaquiss said. “This is an unfortunate and unavoidable weakness of this report, given the recent introduction of VADs for pediatric heart transplant candidates.” The use of VAD in patients with CHD is “increasing rapidly,” he said.
Dr. Jaquiss had no disclosures.
In his invited commentary, Dr. Robert D.B. Jaquiss of Duke University, Durham, N.C., took issue with the study authors’ “distress” at the lack of improvement in survival over the 25-year term of the study (J Thorac Cardiovasc Surg. 2015;150:1463-4) . Using the year 2000 as a demarcation line for early and late-phase results, Dr. Jaquiss said, “It must be pointed out that in the latter period recipients were much more ill.” He noted that 89% of post-2000 heart transplant patients had UNOS status 1 vs. 49% in the pre-2000 period.
|
|
Dr. Robert Jaquiss |
“Considering these between-era differences, an alternative, less ‘discouraging’ interpretation is that excellent outcomes were maintained despite the trend toward transplantation in sicker patients, undergoing more complex transplants, with longer ischemic times,” he said.
Dr. Jaquiss also cited “remarkably outstanding outcomes” in Fontan patients, reporting only one operative death in 33 patients. He found the lower survival for African-American patients in the study group “more sobering,” but also controversial because, among other reasons, “a complete mechanistic explanation remains elusive.” How these findings influence pediatric heart transplant practice “requires thoughtful and extensive investigation and discussion,” he said.
Wait-list mortality and mechanical bridge to transplant also deserve mention, he noted. “Though they are only briefly mentioned, the patients who died prior to transplant provide mute testimony to the lack of timely access to suitable donors,” Dr. Jaquiss said. Durable mechanical circulatory support can provide a bridge for these patients, but was not available through the majority of the study period.
“It is striking that no patient in this report was supported by a ventricular assist device (VAD), and only a small number (5%) had been on [extracorporeal membrane oxygenation] support,” Dr. Jaquiss said. “This is an unfortunate and unavoidable weakness of this report, given the recent introduction of VADs for pediatric heart transplant candidates.” The use of VAD in patients with CHD is “increasing rapidly,” he said.
Dr. Jaquiss had no disclosures.
A 25-year study of heart transplants in children with congenital heart disease (CHD) at one institution has found that results haven’t improved over time despite advances in technology and techniques. To improve outcomes, transplant surgeons may need to do a better job of selecting patients and matching patients and donors, according to study in the December issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2015;150:1455-62).
“Strategies to improve outcomes in CHD patients might need to address selection criteria, transplantation timing, pretransplant and posttransplant care,” noted Dr. Bahaaldin Alsoufi, of the division of cardiothoracic surgery, Children’s Healthcare of Atlanta, Emory University. “The effect of donor/recipient race mismatch warrants further investigation and might impact organ allocation algorithms or immunosuppression management,” wrote Dr. Alsoufi and his colleagues.
The researchers analyzed results of 124 children with CHD who had heart transplants from 1988 to 2013 at Emory University and Children’s Healthcare of Atlanta. Median age was 3.8 years; 61% were boys. Ten years after heart transplantation, 44% (54) of patients were alive without a second transplant, 13% (17) had a second transplant and 43% (53) died without a second transplant. After the second transplant, 9 of the 17 patients were alive, but 3 of them had gone onto a third transplant. Overall 15-year survival following the first transplant was 41% (51).
The study cited data from the Registry of the International Society for Heart and Lung Transplantation that reported more than 11,000 pediatric heart transplants worldwide in 2013, and CHD represents about 54% of all heart transplants in infants.
A multivariate analysis identified the following risk factors for early mortality after transplant: age younger than 12 months (hazard ration [HR] 7.2) and prolonged cardiopulmonary bypass (HR 5). Late-phase mortality risk factors were age younger than 12 months (HR 3) and donor/recipient race mismatch (HR 2.2).
“Survival was not affected by era, underlying anomaly, prior Fontan, sensitization or pulmonary artery augmentation,” wrote Dr. Alsoufi and his colleagues.
Among the risk factors, longer bypass times may be a surrogate for a more complicated operation, the authors said. But where prior sternotomy is a risk factor following a heart transplant in adults, the study found no such risk in children. Another risk factor previous reports identified is pulmonary artery augmentation, but, again, this study found no risk in the pediatric group.
The researchers looked at days on the waiting list, with a median wait of 39 days in the study group. In all, 175 children were listed for transplants, but 51 did not go through for various reasons. Most of the children with CHD who had a heart transplant had previous surgery; only 13% had a primary heart transplant, mostly in the earlier phase of the study.
Dr. Alsoufi and coauthors also identified African American race as a risk factor for lower survival, which is consistent with other reports. But this study agreed with a previous report that donor/recipient race mismatch was a significant risk factor in white and African American patients (Ann Thorac Surg. 2009;87:204-9). “While our finding might be anecdotal and specific to our geographic population, this warrants some investigation and might have some impact on future organ allocation algorithms and immunosuppression management,” the researchers wrote.
The authors had no relevant disclosures. Emory University School of Medicine, Children’s Healthcare of Atlanta provided study funding.
A 25-year study of heart transplants in children with congenital heart disease (CHD) at one institution has found that results haven’t improved over time despite advances in technology and techniques. To improve outcomes, transplant surgeons may need to do a better job of selecting patients and matching patients and donors, according to study in the December issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2015;150:1455-62).
“Strategies to improve outcomes in CHD patients might need to address selection criteria, transplantation timing, pretransplant and posttransplant care,” noted Dr. Bahaaldin Alsoufi, of the division of cardiothoracic surgery, Children’s Healthcare of Atlanta, Emory University. “The effect of donor/recipient race mismatch warrants further investigation and might impact organ allocation algorithms or immunosuppression management,” wrote Dr. Alsoufi and his colleagues.
The researchers analyzed results of 124 children with CHD who had heart transplants from 1988 to 2013 at Emory University and Children’s Healthcare of Atlanta. Median age was 3.8 years; 61% were boys. Ten years after heart transplantation, 44% (54) of patients were alive without a second transplant, 13% (17) had a second transplant and 43% (53) died without a second transplant. After the second transplant, 9 of the 17 patients were alive, but 3 of them had gone onto a third transplant. Overall 15-year survival following the first transplant was 41% (51).
The study cited data from the Registry of the International Society for Heart and Lung Transplantation that reported more than 11,000 pediatric heart transplants worldwide in 2013, and CHD represents about 54% of all heart transplants in infants.
A multivariate analysis identified the following risk factors for early mortality after transplant: age younger than 12 months (hazard ration [HR] 7.2) and prolonged cardiopulmonary bypass (HR 5). Late-phase mortality risk factors were age younger than 12 months (HR 3) and donor/recipient race mismatch (HR 2.2).
“Survival was not affected by era, underlying anomaly, prior Fontan, sensitization or pulmonary artery augmentation,” wrote Dr. Alsoufi and his colleagues.
Among the risk factors, longer bypass times may be a surrogate for a more complicated operation, the authors said. But where prior sternotomy is a risk factor following a heart transplant in adults, the study found no such risk in children. Another risk factor previous reports identified is pulmonary artery augmentation, but, again, this study found no risk in the pediatric group.
The researchers looked at days on the waiting list, with a median wait of 39 days in the study group. In all, 175 children were listed for transplants, but 51 did not go through for various reasons. Most of the children with CHD who had a heart transplant had previous surgery; only 13% had a primary heart transplant, mostly in the earlier phase of the study.
Dr. Alsoufi and coauthors also identified African American race as a risk factor for lower survival, which is consistent with other reports. But this study agreed with a previous report that donor/recipient race mismatch was a significant risk factor in white and African American patients (Ann Thorac Surg. 2009;87:204-9). “While our finding might be anecdotal and specific to our geographic population, this warrants some investigation and might have some impact on future organ allocation algorithms and immunosuppression management,” the researchers wrote.
The authors had no relevant disclosures. Emory University School of Medicine, Children’s Healthcare of Atlanta provided study funding.
Key clinical point: Pediatric heart transplantation outcomes for congenital heart disease haven’t improved in the current era, indicating ongoing challenges.
Major finding: Ten years following heart transplantation, 13% of patients had undergone retransplantation, 43% had died without retransplantation, and 44% were alive without retransplantation.
Data source: A review of 124 children with congenital heart disease who had heart transplantation at a single center.
Disclosures: The study authors had no relationships to disclose.
AHA: Three measures risk stratify acute heart failure
ORLANDO – Three simple, routinely collected measurements together provide a lot of insight into the risk faced by community-dwelling patients hospitalized for acute decompensated heart failure, according to data collected from 3,628 patients at one U.S. center.
The three measures are blood urea nitrogen (BUN), systolic blood pressure, and serum creatinine. Using dichotomous cutoffs first calculated a decade ago, these three parameters distinguish up to an eightfold range of postdischarge mortality during the 30 or 90 days following an index hospitalization, and up to a fourfold range of risk for rehospitalization for heart failure during the ensuing 30 or 90 days, Dr. Sithu Win said at the American Heart Association scientific sessions.
Applying this three-measure assessment to patients hospitalized with acute decompensated heart failure “may guide care-transition planning and promote efficient allocation of limited resources,” said Dr. Win, a cardiologist at the Mayo Clinic in Rochester, Minn. The next step is to try to figure out the best way to use this risk prognostication in routine practice, he added.
Researchers published the original analysis that identified BUN, systolic BP, and serum creatinine as key prognostic measures in 2005 using data taken from more than 65,000 U.S. heart failure patients enrolled in ADHERE (Acute Decompensated Heart Failure National Registry) (JAMA. 2005 Feb 2;293[5]:572-80). Using a classification and regression tree analysis, the 2005 study verified dichotomous cutoffs for these three parameters that identified patients at highest risk for in-hospital mortality.
The 2005 study prioritized the application of these cutoffs to define in-hospital mortality risk: first BUN, then the systolic BP criterion, and lastly the serum creatinine criterion. This resulted in five risk levels: Highest-risk patients had a BUN of at least 43 mg/dL, a systolic BP of less than 115 mm Hg, and a serum creatinine of at least 2.75 mg/dL. Lowest-risk patients had a BUN of less than 43 mg/dL and a systolic BP of more than 115 mm Hg. (In lower-risk patients, serum-creatinine level dropped out as a risk determinant.) The analysis also created three categories of patients with intermediate risk based on various combinations of the three measures.
The new study run by Dr. Win and his associates evaluated how this risk-assessment tool developed to predict in-hospital mortality performed for predicting event rates among community-based heart failure patients who had a total of 5,918 hospitalizations for acute decompensated heart failure at the Mayo Clinic during 2000-2013. They averaged 78 years old, half were women, and 48% had heart failure with preserved ejection fraction.
The risk-level distribution of the 3,628 Mayo patients closely matched the pattern seen in the original ADHERE registry: 63% were low risk, 17% were at intermediate level 3 (the lowest risk level in the intermediate range), 13% were at intermediate level 2, 5% at intermediate level 1, and 2% were categorized as high risk.
For 30-day mortality post hospitalization, patients at the highest risk level had a mortality rate eightfold higher than did the lowest-risk patients, those rated intermediate level 1 had a fivefold higher mortality rate, intermediate level 2 patients had a threefold higher rate, and those at intermediate 3 had a 50% higher rate, Dr. Win reported. During the 90 days after discharge, mortality rates relative to the lowest risk level ranged from a sixfold higher rate among the highest-risk patients to a 50% higher rate among patients with an intermediate 3 designation.
Analysis of rehospitalizations for heart failure showed that, by 30 days after hospitalization, the readmission rate ran threefold higher in the highest-risk patients, compared with those at the lowest risk and fourfold higher among those at intermediate risk level 1. Heart failure readmissions by 90 days following the index hospitalization ran threefold higher for both the highest-risk patients as well as those at intermediate level 1, compared with the patients at lowest risk.
The new analyses also showed that roughly similar risk patterns occurred regardless of whether patients had heart failure with reduced or preserved ejection fraction during their index hospitalization, although the relatively increased rate of 30-day mortality with a worse risk profile was most dramatic among patients with reduced ejection fraction. Age, sex, and comorbidity severity did not have a marked effect on the relationships between event rates and risk levels, Dr. Win said.
Dr. Win had no disclosures.
On Twitter @mitchelzoler
ORLANDO – Three simple, routinely collected measurements together provide a lot of insight into the risk faced by community-dwelling patients hospitalized for acute decompensated heart failure, according to data collected from 3,628 patients at one U.S. center.
The three measures are blood urea nitrogen (BUN), systolic blood pressure, and serum creatinine. Using dichotomous cutoffs first calculated a decade ago, these three parameters distinguish up to an eightfold range of postdischarge mortality during the 30 or 90 days following an index hospitalization, and up to a fourfold range of risk for rehospitalization for heart failure during the ensuing 30 or 90 days, Dr. Sithu Win said at the American Heart Association scientific sessions.
Applying this three-measure assessment to patients hospitalized with acute decompensated heart failure “may guide care-transition planning and promote efficient allocation of limited resources,” said Dr. Win, a cardiologist at the Mayo Clinic in Rochester, Minn. The next step is to try to figure out the best way to use this risk prognostication in routine practice, he added.
Researchers published the original analysis that identified BUN, systolic BP, and serum creatinine as key prognostic measures in 2005 using data taken from more than 65,000 U.S. heart failure patients enrolled in ADHERE (Acute Decompensated Heart Failure National Registry) (JAMA. 2005 Feb 2;293[5]:572-80). Using a classification and regression tree analysis, the 2005 study verified dichotomous cutoffs for these three parameters that identified patients at highest risk for in-hospital mortality.
The 2005 study prioritized the application of these cutoffs to define in-hospital mortality risk: first BUN, then the systolic BP criterion, and lastly the serum creatinine criterion. This resulted in five risk levels: Highest-risk patients had a BUN of at least 43 mg/dL, a systolic BP of less than 115 mm Hg, and a serum creatinine of at least 2.75 mg/dL. Lowest-risk patients had a BUN of less than 43 mg/dL and a systolic BP of more than 115 mm Hg. (In lower-risk patients, serum-creatinine level dropped out as a risk determinant.) The analysis also created three categories of patients with intermediate risk based on various combinations of the three measures.
The new study run by Dr. Win and his associates evaluated how this risk-assessment tool developed to predict in-hospital mortality performed for predicting event rates among community-based heart failure patients who had a total of 5,918 hospitalizations for acute decompensated heart failure at the Mayo Clinic during 2000-2013. They averaged 78 years old, half were women, and 48% had heart failure with preserved ejection fraction.
The risk-level distribution of the 3,628 Mayo patients closely matched the pattern seen in the original ADHERE registry: 63% were low risk, 17% were at intermediate level 3 (the lowest risk level in the intermediate range), 13% were at intermediate level 2, 5% at intermediate level 1, and 2% were categorized as high risk.
For 30-day mortality post hospitalization, patients at the highest risk level had a mortality rate eightfold higher than did the lowest-risk patients, those rated intermediate level 1 had a fivefold higher mortality rate, intermediate level 2 patients had a threefold higher rate, and those at intermediate 3 had a 50% higher rate, Dr. Win reported. During the 90 days after discharge, mortality rates relative to the lowest risk level ranged from a sixfold higher rate among the highest-risk patients to a 50% higher rate among patients with an intermediate 3 designation.
Analysis of rehospitalizations for heart failure showed that, by 30 days after hospitalization, the readmission rate ran threefold higher in the highest-risk patients, compared with those at the lowest risk and fourfold higher among those at intermediate risk level 1. Heart failure readmissions by 90 days following the index hospitalization ran threefold higher for both the highest-risk patients as well as those at intermediate level 1, compared with the patients at lowest risk.
The new analyses also showed that roughly similar risk patterns occurred regardless of whether patients had heart failure with reduced or preserved ejection fraction during their index hospitalization, although the relatively increased rate of 30-day mortality with a worse risk profile was most dramatic among patients with reduced ejection fraction. Age, sex, and comorbidity severity did not have a marked effect on the relationships between event rates and risk levels, Dr. Win said.
Dr. Win had no disclosures.
On Twitter @mitchelzoler
ORLANDO – Three simple, routinely collected measurements together provide a lot of insight into the risk faced by community-dwelling patients hospitalized for acute decompensated heart failure, according to data collected from 3,628 patients at one U.S. center.
The three measures are blood urea nitrogen (BUN), systolic blood pressure, and serum creatinine. Using dichotomous cutoffs first calculated a decade ago, these three parameters distinguish up to an eightfold range of postdischarge mortality during the 30 or 90 days following an index hospitalization, and up to a fourfold range of risk for rehospitalization for heart failure during the ensuing 30 or 90 days, Dr. Sithu Win said at the American Heart Association scientific sessions.
Applying this three-measure assessment to patients hospitalized with acute decompensated heart failure “may guide care-transition planning and promote efficient allocation of limited resources,” said Dr. Win, a cardiologist at the Mayo Clinic in Rochester, Minn. The next step is to try to figure out the best way to use this risk prognostication in routine practice, he added.
Researchers published the original analysis that identified BUN, systolic BP, and serum creatinine as key prognostic measures in 2005 using data taken from more than 65,000 U.S. heart failure patients enrolled in ADHERE (Acute Decompensated Heart Failure National Registry) (JAMA. 2005 Feb 2;293[5]:572-80). Using a classification and regression tree analysis, the 2005 study verified dichotomous cutoffs for these three parameters that identified patients at highest risk for in-hospital mortality.
The 2005 study prioritized the application of these cutoffs to define in-hospital mortality risk: first BUN, then the systolic BP criterion, and lastly the serum creatinine criterion. This resulted in five risk levels: Highest-risk patients had a BUN of at least 43 mg/dL, a systolic BP of less than 115 mm Hg, and a serum creatinine of at least 2.75 mg/dL. Lowest-risk patients had a BUN of less than 43 mg/dL and a systolic BP of more than 115 mm Hg. (In lower-risk patients, serum-creatinine level dropped out as a risk determinant.) The analysis also created three categories of patients with intermediate risk based on various combinations of the three measures.
The new study run by Dr. Win and his associates evaluated how this risk-assessment tool developed to predict in-hospital mortality performed for predicting event rates among community-based heart failure patients who had a total of 5,918 hospitalizations for acute decompensated heart failure at the Mayo Clinic during 2000-2013. They averaged 78 years old, half were women, and 48% had heart failure with preserved ejection fraction.
The risk-level distribution of the 3,628 Mayo patients closely matched the pattern seen in the original ADHERE registry: 63% were low risk, 17% were at intermediate level 3 (the lowest risk level in the intermediate range), 13% were at intermediate level 2, 5% at intermediate level 1, and 2% were categorized as high risk.
For 30-day mortality post hospitalization, patients at the highest risk level had a mortality rate eightfold higher than did the lowest-risk patients, those rated intermediate level 1 had a fivefold higher mortality rate, intermediate level 2 patients had a threefold higher rate, and those at intermediate 3 had a 50% higher rate, Dr. Win reported. During the 90 days after discharge, mortality rates relative to the lowest risk level ranged from a sixfold higher rate among the highest-risk patients to a 50% higher rate among patients with an intermediate 3 designation.
Analysis of rehospitalizations for heart failure showed that, by 30 days after hospitalization, the readmission rate ran threefold higher in the highest-risk patients, compared with those at the lowest risk and fourfold higher among those at intermediate risk level 1. Heart failure readmissions by 90 days following the index hospitalization ran threefold higher for both the highest-risk patients as well as those at intermediate level 1, compared with the patients at lowest risk.
The new analyses also showed that roughly similar risk patterns occurred regardless of whether patients had heart failure with reduced or preserved ejection fraction during their index hospitalization, although the relatively increased rate of 30-day mortality with a worse risk profile was most dramatic among patients with reduced ejection fraction. Age, sex, and comorbidity severity did not have a marked effect on the relationships between event rates and risk levels, Dr. Win said.
Dr. Win had no disclosures.
On Twitter @mitchelzoler
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point: Dichotomous cutoffs for BUN, systolic BP, and serum creatinine together robustly risk stratified patients hospitalized for acute decompensated heart failure.
Major finding: Three baseline measures together stratified patients over an eightfold range for 30-day mortality following hospital discharge.
Data source: Application of the risk-stratification formula to 3,628 heart failure patients hospitalized at one U.S. center during 2000-2013.
Disclosures: Dr. Win had no disclosures.
