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The Official Newspaper of the American Association for Thoracic Surgery
Parents seek easily understood public reporting of cardiac outcome measures
HOUSTON – Parents of children with congenital heart disease cite survival statistics, surgeon-specific experience, and complication rates as the three most important congenital heart surgery outcome measures to report publicly, results from a large survey show.
“Recently, an increasing demand for the public reporting of pediatric heart surgery outcomes has led to the development of several different reporting schemes, including a hospital star rating system and procedure-specific mortality data tables for the Society of Thoracic Surgeons benchmark operations,” study investigator Mallory L. Irons, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “However, despite the availability of these reporting schemes, there remain unanswered questions about the optimal format and content of public reporting for pediatric heart surgery outcomes.”
“These procedures have been determined to represent more homogenous patient groups,” she said. “How data [are] presented may be just as important as the data itself. Noticeably absent from these frameworks is parent input regarding the information that may be necessary to make an informed choice about their child’s care.
“Failure to consider this perspective may contribute to suboptimal reporting and misunderstanding of the data presented. The goal of the current study was to identify parent preferences regarding the content of pediatric heart surgery outcomes reports, specifically with respect to the type of data that is included as well as the optimal format for presentation of this data.”
She and her associates developed a 43-question survey for 1,862 parents of children born with heart defects. The parents were invited to participate through member lists from patient advocacy groups Mended Little Hearts, the Pediatric Congenital Heart Association, and Sisters by Heart, and from a cohort of patients who underwent surgical correction for an STS benchmark procedure at the Children’s Hospital of Philadelphia after Jan. 1, 2007.
Of the 1,862 parents, 1,281 (69%) provided complete responses for inclusion in the final analysis. The mean age of respondents was 37 years, 92% were mothers of children with congenital heart disease, and 92% were white. “Most reported household incomes in excess of $65,000 per year, but lower income households were also significantly represented,” Dr. Irons added. More than half of the children (57%) were diagnosed with CHD prenatally, 63% underwent an initial repair in the neonatal period, and 60% of families were referred to a cardiac surgical center by a physician, while 23% were transferred from their birth hospital.
When the respondents were asked to rank categories of outcome measures or other types of information to include in an optimal public reporting scheme on a scale of 1 (most important) to 8 (least important), they identified survival statistics, surgeons’ experience with congenital heart surgery, and complication rates as the three most important. These preferences were stable across differences in education levels, household incomes, and race or ethnicity, Dr. Irons said.
Presented with three display formats for hospital-specific mortality rates, most parents (89%) identified a numerical procedure-based approach as the best format, and more than half (60%) identified the hospital star rating system as the worst potential format to display mortality data. These preferences also were stable across differences in education levels, household incomes, and race or ethnicity.
Dr. Irons acknowledged certain limitations of the study, including its retrospective design, and the fact that it lacked input from parents who do not have Internet access. “Similarly, the availability of the survey in English only prevents non-native English speakers from contributing,” she said. “Finally, while we have identified what types of information parents want, we must acknowledge that small case numbers limit the presentation of certain types of data, such as surgeon-specific outcomes, in a statistically meaningful way.”
In her opinion, an optimal reporting system requires a common database in which to collect and analyze data, a robust methodology for risk adjustment, and a way to compare performance across a field that is inherently heterogeneous.
“The ideal public reporting system should be valid as well as easily understood by all stakeholders,” Dr. Irons concluded. “We must recognize that just because parents want certain data, [it] does not mean that we can provide it in a meaningful, statistically valid way. Perhaps the most important takeaway from our study is the importance of involving parents and other stakeholders in the design and planning of methodologies for public reporting of congenital heart surgery outcomes. Ultimately, the optimal platform will represent a melding of what parents want, and what is statistically meaningful and valid.”
Jeffrey P. Jacobs, MD, a pediatric heart surgeon at Johns Hopkins University, Baltimore, who also chairs the STS Workforce on National Databases, characterized the study as “an extremely important paper that examines the format and structure of how it might be best to share information about cardiac surgical outcomes with patients and their families.” He said the STS “has studied multiple different strategies, and currently we use a method where we report outcomes using a categorical system of star ratings and augment that with detailed specific data with point estimates for confidence intervals. We continue to study and explore better ways to share this information with our patients and with their families.”
Dr. Irons reported having no financial disclosures.
HOUSTON – Parents of children with congenital heart disease cite survival statistics, surgeon-specific experience, and complication rates as the three most important congenital heart surgery outcome measures to report publicly, results from a large survey show.
“Recently, an increasing demand for the public reporting of pediatric heart surgery outcomes has led to the development of several different reporting schemes, including a hospital star rating system and procedure-specific mortality data tables for the Society of Thoracic Surgeons benchmark operations,” study investigator Mallory L. Irons, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “However, despite the availability of these reporting schemes, there remain unanswered questions about the optimal format and content of public reporting for pediatric heart surgery outcomes.”
“These procedures have been determined to represent more homogenous patient groups,” she said. “How data [are] presented may be just as important as the data itself. Noticeably absent from these frameworks is parent input regarding the information that may be necessary to make an informed choice about their child’s care.
“Failure to consider this perspective may contribute to suboptimal reporting and misunderstanding of the data presented. The goal of the current study was to identify parent preferences regarding the content of pediatric heart surgery outcomes reports, specifically with respect to the type of data that is included as well as the optimal format for presentation of this data.”
She and her associates developed a 43-question survey for 1,862 parents of children born with heart defects. The parents were invited to participate through member lists from patient advocacy groups Mended Little Hearts, the Pediatric Congenital Heart Association, and Sisters by Heart, and from a cohort of patients who underwent surgical correction for an STS benchmark procedure at the Children’s Hospital of Philadelphia after Jan. 1, 2007.
Of the 1,862 parents, 1,281 (69%) provided complete responses for inclusion in the final analysis. The mean age of respondents was 37 years, 92% were mothers of children with congenital heart disease, and 92% were white. “Most reported household incomes in excess of $65,000 per year, but lower income households were also significantly represented,” Dr. Irons added. More than half of the children (57%) were diagnosed with CHD prenatally, 63% underwent an initial repair in the neonatal period, and 60% of families were referred to a cardiac surgical center by a physician, while 23% were transferred from their birth hospital.
When the respondents were asked to rank categories of outcome measures or other types of information to include in an optimal public reporting scheme on a scale of 1 (most important) to 8 (least important), they identified survival statistics, surgeons’ experience with congenital heart surgery, and complication rates as the three most important. These preferences were stable across differences in education levels, household incomes, and race or ethnicity, Dr. Irons said.
Presented with three display formats for hospital-specific mortality rates, most parents (89%) identified a numerical procedure-based approach as the best format, and more than half (60%) identified the hospital star rating system as the worst potential format to display mortality data. These preferences also were stable across differences in education levels, household incomes, and race or ethnicity.
Dr. Irons acknowledged certain limitations of the study, including its retrospective design, and the fact that it lacked input from parents who do not have Internet access. “Similarly, the availability of the survey in English only prevents non-native English speakers from contributing,” she said. “Finally, while we have identified what types of information parents want, we must acknowledge that small case numbers limit the presentation of certain types of data, such as surgeon-specific outcomes, in a statistically meaningful way.”
In her opinion, an optimal reporting system requires a common database in which to collect and analyze data, a robust methodology for risk adjustment, and a way to compare performance across a field that is inherently heterogeneous.
“The ideal public reporting system should be valid as well as easily understood by all stakeholders,” Dr. Irons concluded. “We must recognize that just because parents want certain data, [it] does not mean that we can provide it in a meaningful, statistically valid way. Perhaps the most important takeaway from our study is the importance of involving parents and other stakeholders in the design and planning of methodologies for public reporting of congenital heart surgery outcomes. Ultimately, the optimal platform will represent a melding of what parents want, and what is statistically meaningful and valid.”
Jeffrey P. Jacobs, MD, a pediatric heart surgeon at Johns Hopkins University, Baltimore, who also chairs the STS Workforce on National Databases, characterized the study as “an extremely important paper that examines the format and structure of how it might be best to share information about cardiac surgical outcomes with patients and their families.” He said the STS “has studied multiple different strategies, and currently we use a method where we report outcomes using a categorical system of star ratings and augment that with detailed specific data with point estimates for confidence intervals. We continue to study and explore better ways to share this information with our patients and with their families.”
Dr. Irons reported having no financial disclosures.
HOUSTON – Parents of children with congenital heart disease cite survival statistics, surgeon-specific experience, and complication rates as the three most important congenital heart surgery outcome measures to report publicly, results from a large survey show.
“Recently, an increasing demand for the public reporting of pediatric heart surgery outcomes has led to the development of several different reporting schemes, including a hospital star rating system and procedure-specific mortality data tables for the Society of Thoracic Surgeons benchmark operations,” study investigator Mallory L. Irons, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “However, despite the availability of these reporting schemes, there remain unanswered questions about the optimal format and content of public reporting for pediatric heart surgery outcomes.”
“These procedures have been determined to represent more homogenous patient groups,” she said. “How data [are] presented may be just as important as the data itself. Noticeably absent from these frameworks is parent input regarding the information that may be necessary to make an informed choice about their child’s care.
“Failure to consider this perspective may contribute to suboptimal reporting and misunderstanding of the data presented. The goal of the current study was to identify parent preferences regarding the content of pediatric heart surgery outcomes reports, specifically with respect to the type of data that is included as well as the optimal format for presentation of this data.”
She and her associates developed a 43-question survey for 1,862 parents of children born with heart defects. The parents were invited to participate through member lists from patient advocacy groups Mended Little Hearts, the Pediatric Congenital Heart Association, and Sisters by Heart, and from a cohort of patients who underwent surgical correction for an STS benchmark procedure at the Children’s Hospital of Philadelphia after Jan. 1, 2007.
Of the 1,862 parents, 1,281 (69%) provided complete responses for inclusion in the final analysis. The mean age of respondents was 37 years, 92% were mothers of children with congenital heart disease, and 92% were white. “Most reported household incomes in excess of $65,000 per year, but lower income households were also significantly represented,” Dr. Irons added. More than half of the children (57%) were diagnosed with CHD prenatally, 63% underwent an initial repair in the neonatal period, and 60% of families were referred to a cardiac surgical center by a physician, while 23% were transferred from their birth hospital.
When the respondents were asked to rank categories of outcome measures or other types of information to include in an optimal public reporting scheme on a scale of 1 (most important) to 8 (least important), they identified survival statistics, surgeons’ experience with congenital heart surgery, and complication rates as the three most important. These preferences were stable across differences in education levels, household incomes, and race or ethnicity, Dr. Irons said.
Presented with three display formats for hospital-specific mortality rates, most parents (89%) identified a numerical procedure-based approach as the best format, and more than half (60%) identified the hospital star rating system as the worst potential format to display mortality data. These preferences also were stable across differences in education levels, household incomes, and race or ethnicity.
Dr. Irons acknowledged certain limitations of the study, including its retrospective design, and the fact that it lacked input from parents who do not have Internet access. “Similarly, the availability of the survey in English only prevents non-native English speakers from contributing,” she said. “Finally, while we have identified what types of information parents want, we must acknowledge that small case numbers limit the presentation of certain types of data, such as surgeon-specific outcomes, in a statistically meaningful way.”
In her opinion, an optimal reporting system requires a common database in which to collect and analyze data, a robust methodology for risk adjustment, and a way to compare performance across a field that is inherently heterogeneous.
“The ideal public reporting system should be valid as well as easily understood by all stakeholders,” Dr. Irons concluded. “We must recognize that just because parents want certain data, [it] does not mean that we can provide it in a meaningful, statistically valid way. Perhaps the most important takeaway from our study is the importance of involving parents and other stakeholders in the design and planning of methodologies for public reporting of congenital heart surgery outcomes. Ultimately, the optimal platform will represent a melding of what parents want, and what is statistically meaningful and valid.”
Jeffrey P. Jacobs, MD, a pediatric heart surgeon at Johns Hopkins University, Baltimore, who also chairs the STS Workforce on National Databases, characterized the study as “an extremely important paper that examines the format and structure of how it might be best to share information about cardiac surgical outcomes with patients and their families.” He said the STS “has studied multiple different strategies, and currently we use a method where we report outcomes using a categorical system of star ratings and augment that with detailed specific data with point estimates for confidence intervals. We continue to study and explore better ways to share this information with our patients and with their families.”
Dr. Irons reported having no financial disclosures.
AT THE STS ANNUAL MEETING
Key clinical point:
Major finding: When parents of children with congenital heart disease were asked to rank categories of outcome measures or other types of information to include in an optimal public reporting scheme, they identified survival statistics, surgeons’ experience with congenital heart surgery, and complication rates as the three most important
Data source: A retrospective survey of 1,862 parents of children born with heart defects.
Disclosures: Dr. Irons reported having no financial disclosures.
Sleep apnea may induce distinct form of atrial fibrillation
ORLANDO – Patients with atrial fibrillation (AF) should be screened for obstructive sleep apnea (OSA), because this information may be useful in guiding ablation strategies, according to results of a prospective study.
The study, which associated OSA in AF with a high relative rate of non–pulmonary vein (PV) triggers, has contributed to the “growing body of evidence implicating sleep apnea in atrial remodeling and promotion of the AF substrate,” Elad Anter, MD, associate director of the clinical electrophysiology laboratory at Beth Israel Deaconess Medical Center, Boston, reported at the annual International AF Symposium.
Despite the close association between OSA and AF, it has been unclear whether OSA is a causative factor. Dr. Anter suggested that mechanistic association is strengthening, however.
It has been hypothesized that OSA generates AF substrate through negative intrathoracic pressure changes and autonomic nervous system activation. But Dr. Anter reported that there is more recent and compelling evidence that the repetitive occlusions produced by OSA result in remodeling of the atria, producing scar tissue that slows conduction and produces susceptibility to reentry AF.
A newly completed prospective multicenter study adds support to this latter hypothesis. In the protocol, patients with paroxysmal AF scheduled for ablation were required to undergo a sleep study, an AF mapping study, and follow-up for at least 12 months. A known history of OSA was an exclusion criterion. To isolate the effect of OSA, there were exclusions for other major etiologies for AF, such as heart failure or coronary artery disease.
The AF mapping was conducted when patients were in sinus rhythm “to evaluate the baseline atrial substrate and avoid measurements related to acute electrical remodeling,” Dr. Anter explained.
Of 172 patients initially enrolled, 133 completed the sleep study, 118 completed the mapping study, and 110 completed both and were followed for at least 12 months. Of these, 43 patients without OSA were compared with 43 patients with OSA defined as an apnea-hypopnea index (AHI) of at least 15. Patients in the two groups did not differ significantly for relevant characteristics, such as body mass index (BMI), age, presence of hypertension, or duration of AF; but the left atrial (LA) volume was significantly greater (P = .01) in those with OSA than those without.
Even though the prevalence of voltage abnormalities was higher in the OSA group for the right (P = .01) and left atria (P = .0001) before ablation, the prevalence of PV triggers (63% vs. 65%), non-PV triggers (19% vs. 12%) and noninducible triggers (19% vs. 23%) were similar.
After ablation, PV triggers were no longer inducible in either group, but there was a striking difference in inducible non-PV triggers. While only 11.6% remained inducible in the non-OSA group, 41.8% (P = .003) remained inducible in the OSA patients.
“AF triggers in OSA were most commonly located at the LA septum, at the zone of low voltage and abnormal electrograms, as determined during sinus rhythm,” Dr. Anter reported. “Ablation of these triggers at the zone of tissue abnormality in the OSA patients resulted in termination of AF in 9 (64.2%) of the 14 patients.”
Overall, at the end of 12 months, 79% of those without OSA remained in arrhythmia-free survival, versus 65.1% of the group with OSA that were treated with PV isolation alone.
The lower rate of success in the OSA group shows the importance of specifically directing ablation to the areas of low voltage and slow conduction in the left anterior septum that Dr. Anter indicated otherwise would be missed.
“These zones are a common source of extra-PV triggers and localized circuits or rotors of AF in OSA patients,” he reported. “Ablation of these low voltage zones is associated with improved clinical outcome in OSA patients with paroxysmal AF.”
The data, which Dr. Anter said are consistent with a growing body of work regarding the relationship of OSA and AF, provided the basis for suggesting that AF patients undergo routine screening for OSA.
In patients with OSA, ablation of PV triggers alone even in paroxysmal PAF “may not be sufficient,” he cautioned. “Evaluation of non-PV triggers should also be performed.”
Dr. Anter reported financial relationships with Biosense Webster and Boston Scientific.
Atrial fibrillation (AF) is the most common cardiac arrhythmia encountered in clinical practice and is associated with increased morbidity and mortality due to thromboembolism, stroke, and worsening of pre-existing heart failure. Both its incidence and prevalence are increasing as AF risk increases with advancing age.1 While the strategies of heart rate control and anticoagulation to lower stroke risk and rhythm control have been found comparable with regard to survival, many patients remain highly symptomatic because of palpitations and reduced cardiac output.1
Structural abnormalities of the atria, including fibrosis and dilation, accompanied by conduction abnormalities, provide the underlying substrate for AF. It is well established that AF episodes perpetuate atrial remodeling leading to more frequent and prolonged AF episodes. Hence, there is the long-standing notion that “AF begets AF.” While a variety of antiarrhythmic drugs have been employed over the years to prevent AF recurrences and to maintain sinus rhythm, their use has decreased over the past 2 decades due to their major side effects and their potential of proarrhythmia.
Since AF patients represent a heterogeneous group of patients with CV diseases of varying type and severity as well as comorbidities, it stands to reason that the pulmonary venous–left atrial junction may not be the sole culprit region of all cases of AF and that other anatomical locations might serve as triggers for AF.
In support of this notion are the results of the prospective multicenter study presented by Dr. Elad Anter at the annual International AF Symposium. This important study is consistent with and expands upon prior studies that have suggested that sites within the atria remote from the pulmonary veins may serve as triggers for AF, rather than lower technical success of pulmonary vein ablation.5 It further highlights the importance of fibrosis and associated electrical dispersion to the pathogenesis of AF.6 However, the recommendation that patients with AF be screened for OSA is not new, as nearly half of patients with AF also have OSA.7 While AF and OSA share common risk factors/comorbidities such as male gender, obesity, hypertension, coronary artery disease, and congestive heart failure, OSA has been found to be an independent risk factor for AF development.
It is important to know whether OSA was treated, as the presence of OSA raises the risk of AF recurrence and OSA treatment decreases AF recurrence after ablation.8,9 Conversely, in the setting of OSA, AF is more resistive to rhythm control. Enhanced vagal activation, elevated sympathetic tone, and oxidative stresses due to oxygen desaturation and left atrial distension have all been implicated in the pathogenesis linking OSA to the development of AF. Repeated increases in upper airway resistance during airway obstruction have been shown to lead to atrial stretch, dilation, and fibrosis.10 Since patients with heart failure, coronary artery disease, and other underlying causes for AF were excluded from the onset, the results may not be applicable to a large segment of AF patients. Exclusion of underlying cardiac conditions potentially raised the yield of patients found to have OSA and the potential value of OSA screening. Of note: Less than half of patients that were enrolled had complete data for analysis, which may further limit applicability of the study findings. All patients had paroxysmal AF and were in sinus rhythm while the mapping procedure was performed, leaving questions as to how to approach patients presenting acutely with persistent or long standing AF, or those recently treated with antiarrhythmic therapy. Also, since arrhythmia-free survival decreases from 1 to 5 years after AF ablation, and short-time success rates do not predict longer success rates, the present study results should be interpreted with cautious optimism.11
However, these limitations should not detract from the major implications of the study. In the setting of AF, OSA should be clinically suspected not only because of the frequent coexistence of the two disorders but because the presence of OSA should prompt electrophysiologists to consider non–pulmonary vein triggers of AF prior to ablation attempts. The consideration of alternative ablation sites might help to explain the lack of ablation procedure endpoints to predict long-term success of ablation and holds promise for increasing technical success rates. Given that airway obstruction may occur in other clinical settings such as seizure-induced laryngospasm and that seizures may induce arrhythmias and sudden death, there is potential for non–pulmonary vein sites to trigger AF and other arrhythmias in settings other than OSA as well.12 Whether other disease states are associated with a higher likelihood of non-pulmonary veins trigger sites also merits further study. Moreover, this study underscores the notion that with regard to AF ablation, “no one site fits all” and “clinical mapping” may serve as a valuable adjunct to anatomical mapping. It also serves as a reminder of the multidisciplinary nature of Chest Medicine and the need of a team oriented approach..
References
1. Iwasaki YK, Nishida K, Kato T, Nattel S. Atrial fibrillation pathophysiology: implications for management. Circulation. 2011;124:2264-74.
2. Verma A, Jiang CY, Betts TR, et al. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015;372:1812-22.
3. Kuck KH, Brugada J, Fürnkranz A, et al. Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. N Engl J Med. 2016;374:2235-45.
4. Calkins H, Reynolds MR, Spector P, et al. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol. 2009;2:349-61.
5. Narayan SM, Krummen DE, Shivkumar K, et al. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012;60:628-36.
6. Kottkamp H, Berg J, Bender R, et al. Box Isolation of Fibrotic Areas (BIFA): a patient-tailored substrate modified application approach for ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2016;27:22-30.
7. Stevenson IH, Teichtahl H, Cunnington D, et al. Prevalence of sleep disordered breathing in paroxysmal and persistent atrial fibrillation patients with normal left ventricular function. Eur Heart J. 2008;29:1662-9.
8. Fein AS, Shvilkin A, Shah D, et al. Treatment of obstructive sleep apnea reduces the risk of atrial fibrillation recurrence after catheter ablation. J Am Coll Cardiol. 2013;62:300-5.
9. Naruse Y, Tada H, Satoh M, et al. Concomitant obstructive sleep apnea increases the recurrence of atrial fibrillation following radiofrequency catheter ablation of atrial fibrillation: clinical impact of continuous positive airway pressure therapy. Heart Rhythm. 2013;10:331-7.
10. Otto M, Belohlavek M, Romero-Corral A, et al. Comparison of cardiac structural and functional changes in obese otherwise healthy adults with versus without obstructive sleep apnea. Am J Cardiol. 2007;99:1298-302.
11. Kis Z, Muka T, Franco OH, et al. The short and long-term efficacy of pulmonary vein isolation as a sole treatment strategy for paroxysmal atrial fibrillation: a systematic review and meta-analysis. Curr Cardiol Rev. 2017 Jan 17. [Epub ahead of print].
12. Nakase K, Kollmar R, Lazar J, et al. Laryngospasm, central and obstructive apnea during seizures: defining pathophysiology for sudden death in a rat model. Epilepsy Res. 2016;128:126-39.
Atrial fibrillation (AF) is the most common cardiac arrhythmia encountered in clinical practice and is associated with increased morbidity and mortality due to thromboembolism, stroke, and worsening of pre-existing heart failure. Both its incidence and prevalence are increasing as AF risk increases with advancing age.1 While the strategies of heart rate control and anticoagulation to lower stroke risk and rhythm control have been found comparable with regard to survival, many patients remain highly symptomatic because of palpitations and reduced cardiac output.1
Structural abnormalities of the atria, including fibrosis and dilation, accompanied by conduction abnormalities, provide the underlying substrate for AF. It is well established that AF episodes perpetuate atrial remodeling leading to more frequent and prolonged AF episodes. Hence, there is the long-standing notion that “AF begets AF.” While a variety of antiarrhythmic drugs have been employed over the years to prevent AF recurrences and to maintain sinus rhythm, their use has decreased over the past 2 decades due to their major side effects and their potential of proarrhythmia.
Since AF patients represent a heterogeneous group of patients with CV diseases of varying type and severity as well as comorbidities, it stands to reason that the pulmonary venous–left atrial junction may not be the sole culprit region of all cases of AF and that other anatomical locations might serve as triggers for AF.
In support of this notion are the results of the prospective multicenter study presented by Dr. Elad Anter at the annual International AF Symposium. This important study is consistent with and expands upon prior studies that have suggested that sites within the atria remote from the pulmonary veins may serve as triggers for AF, rather than lower technical success of pulmonary vein ablation.5 It further highlights the importance of fibrosis and associated electrical dispersion to the pathogenesis of AF.6 However, the recommendation that patients with AF be screened for OSA is not new, as nearly half of patients with AF also have OSA.7 While AF and OSA share common risk factors/comorbidities such as male gender, obesity, hypertension, coronary artery disease, and congestive heart failure, OSA has been found to be an independent risk factor for AF development.
It is important to know whether OSA was treated, as the presence of OSA raises the risk of AF recurrence and OSA treatment decreases AF recurrence after ablation.8,9 Conversely, in the setting of OSA, AF is more resistive to rhythm control. Enhanced vagal activation, elevated sympathetic tone, and oxidative stresses due to oxygen desaturation and left atrial distension have all been implicated in the pathogenesis linking OSA to the development of AF. Repeated increases in upper airway resistance during airway obstruction have been shown to lead to atrial stretch, dilation, and fibrosis.10 Since patients with heart failure, coronary artery disease, and other underlying causes for AF were excluded from the onset, the results may not be applicable to a large segment of AF patients. Exclusion of underlying cardiac conditions potentially raised the yield of patients found to have OSA and the potential value of OSA screening. Of note: Less than half of patients that were enrolled had complete data for analysis, which may further limit applicability of the study findings. All patients had paroxysmal AF and were in sinus rhythm while the mapping procedure was performed, leaving questions as to how to approach patients presenting acutely with persistent or long standing AF, or those recently treated with antiarrhythmic therapy. Also, since arrhythmia-free survival decreases from 1 to 5 years after AF ablation, and short-time success rates do not predict longer success rates, the present study results should be interpreted with cautious optimism.11
However, these limitations should not detract from the major implications of the study. In the setting of AF, OSA should be clinically suspected not only because of the frequent coexistence of the two disorders but because the presence of OSA should prompt electrophysiologists to consider non–pulmonary vein triggers of AF prior to ablation attempts. The consideration of alternative ablation sites might help to explain the lack of ablation procedure endpoints to predict long-term success of ablation and holds promise for increasing technical success rates. Given that airway obstruction may occur in other clinical settings such as seizure-induced laryngospasm and that seizures may induce arrhythmias and sudden death, there is potential for non–pulmonary vein sites to trigger AF and other arrhythmias in settings other than OSA as well.12 Whether other disease states are associated with a higher likelihood of non-pulmonary veins trigger sites also merits further study. Moreover, this study underscores the notion that with regard to AF ablation, “no one site fits all” and “clinical mapping” may serve as a valuable adjunct to anatomical mapping. It also serves as a reminder of the multidisciplinary nature of Chest Medicine and the need of a team oriented approach..
References
1. Iwasaki YK, Nishida K, Kato T, Nattel S. Atrial fibrillation pathophysiology: implications for management. Circulation. 2011;124:2264-74.
2. Verma A, Jiang CY, Betts TR, et al. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015;372:1812-22.
3. Kuck KH, Brugada J, Fürnkranz A, et al. Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. N Engl J Med. 2016;374:2235-45.
4. Calkins H, Reynolds MR, Spector P, et al. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol. 2009;2:349-61.
5. Narayan SM, Krummen DE, Shivkumar K, et al. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012;60:628-36.
6. Kottkamp H, Berg J, Bender R, et al. Box Isolation of Fibrotic Areas (BIFA): a patient-tailored substrate modified application approach for ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2016;27:22-30.
7. Stevenson IH, Teichtahl H, Cunnington D, et al. Prevalence of sleep disordered breathing in paroxysmal and persistent atrial fibrillation patients with normal left ventricular function. Eur Heart J. 2008;29:1662-9.
8. Fein AS, Shvilkin A, Shah D, et al. Treatment of obstructive sleep apnea reduces the risk of atrial fibrillation recurrence after catheter ablation. J Am Coll Cardiol. 2013;62:300-5.
9. Naruse Y, Tada H, Satoh M, et al. Concomitant obstructive sleep apnea increases the recurrence of atrial fibrillation following radiofrequency catheter ablation of atrial fibrillation: clinical impact of continuous positive airway pressure therapy. Heart Rhythm. 2013;10:331-7.
10. Otto M, Belohlavek M, Romero-Corral A, et al. Comparison of cardiac structural and functional changes in obese otherwise healthy adults with versus without obstructive sleep apnea. Am J Cardiol. 2007;99:1298-302.
11. Kis Z, Muka T, Franco OH, et al. The short and long-term efficacy of pulmonary vein isolation as a sole treatment strategy for paroxysmal atrial fibrillation: a systematic review and meta-analysis. Curr Cardiol Rev. 2017 Jan 17. [Epub ahead of print].
12. Nakase K, Kollmar R, Lazar J, et al. Laryngospasm, central and obstructive apnea during seizures: defining pathophysiology for sudden death in a rat model. Epilepsy Res. 2016;128:126-39.
Atrial fibrillation (AF) is the most common cardiac arrhythmia encountered in clinical practice and is associated with increased morbidity and mortality due to thromboembolism, stroke, and worsening of pre-existing heart failure. Both its incidence and prevalence are increasing as AF risk increases with advancing age.1 While the strategies of heart rate control and anticoagulation to lower stroke risk and rhythm control have been found comparable with regard to survival, many patients remain highly symptomatic because of palpitations and reduced cardiac output.1
Structural abnormalities of the atria, including fibrosis and dilation, accompanied by conduction abnormalities, provide the underlying substrate for AF. It is well established that AF episodes perpetuate atrial remodeling leading to more frequent and prolonged AF episodes. Hence, there is the long-standing notion that “AF begets AF.” While a variety of antiarrhythmic drugs have been employed over the years to prevent AF recurrences and to maintain sinus rhythm, their use has decreased over the past 2 decades due to their major side effects and their potential of proarrhythmia.
Since AF patients represent a heterogeneous group of patients with CV diseases of varying type and severity as well as comorbidities, it stands to reason that the pulmonary venous–left atrial junction may not be the sole culprit region of all cases of AF and that other anatomical locations might serve as triggers for AF.
In support of this notion are the results of the prospective multicenter study presented by Dr. Elad Anter at the annual International AF Symposium. This important study is consistent with and expands upon prior studies that have suggested that sites within the atria remote from the pulmonary veins may serve as triggers for AF, rather than lower technical success of pulmonary vein ablation.5 It further highlights the importance of fibrosis and associated electrical dispersion to the pathogenesis of AF.6 However, the recommendation that patients with AF be screened for OSA is not new, as nearly half of patients with AF also have OSA.7 While AF and OSA share common risk factors/comorbidities such as male gender, obesity, hypertension, coronary artery disease, and congestive heart failure, OSA has been found to be an independent risk factor for AF development.
It is important to know whether OSA was treated, as the presence of OSA raises the risk of AF recurrence and OSA treatment decreases AF recurrence after ablation.8,9 Conversely, in the setting of OSA, AF is more resistive to rhythm control. Enhanced vagal activation, elevated sympathetic tone, and oxidative stresses due to oxygen desaturation and left atrial distension have all been implicated in the pathogenesis linking OSA to the development of AF. Repeated increases in upper airway resistance during airway obstruction have been shown to lead to atrial stretch, dilation, and fibrosis.10 Since patients with heart failure, coronary artery disease, and other underlying causes for AF were excluded from the onset, the results may not be applicable to a large segment of AF patients. Exclusion of underlying cardiac conditions potentially raised the yield of patients found to have OSA and the potential value of OSA screening. Of note: Less than half of patients that were enrolled had complete data for analysis, which may further limit applicability of the study findings. All patients had paroxysmal AF and were in sinus rhythm while the mapping procedure was performed, leaving questions as to how to approach patients presenting acutely with persistent or long standing AF, or those recently treated with antiarrhythmic therapy. Also, since arrhythmia-free survival decreases from 1 to 5 years after AF ablation, and short-time success rates do not predict longer success rates, the present study results should be interpreted with cautious optimism.11
However, these limitations should not detract from the major implications of the study. In the setting of AF, OSA should be clinically suspected not only because of the frequent coexistence of the two disorders but because the presence of OSA should prompt electrophysiologists to consider non–pulmonary vein triggers of AF prior to ablation attempts. The consideration of alternative ablation sites might help to explain the lack of ablation procedure endpoints to predict long-term success of ablation and holds promise for increasing technical success rates. Given that airway obstruction may occur in other clinical settings such as seizure-induced laryngospasm and that seizures may induce arrhythmias and sudden death, there is potential for non–pulmonary vein sites to trigger AF and other arrhythmias in settings other than OSA as well.12 Whether other disease states are associated with a higher likelihood of non-pulmonary veins trigger sites also merits further study. Moreover, this study underscores the notion that with regard to AF ablation, “no one site fits all” and “clinical mapping” may serve as a valuable adjunct to anatomical mapping. It also serves as a reminder of the multidisciplinary nature of Chest Medicine and the need of a team oriented approach..
References
1. Iwasaki YK, Nishida K, Kato T, Nattel S. Atrial fibrillation pathophysiology: implications for management. Circulation. 2011;124:2264-74.
2. Verma A, Jiang CY, Betts TR, et al. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015;372:1812-22.
3. Kuck KH, Brugada J, Fürnkranz A, et al. Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. N Engl J Med. 2016;374:2235-45.
4. Calkins H, Reynolds MR, Spector P, et al. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol. 2009;2:349-61.
5. Narayan SM, Krummen DE, Shivkumar K, et al. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012;60:628-36.
6. Kottkamp H, Berg J, Bender R, et al. Box Isolation of Fibrotic Areas (BIFA): a patient-tailored substrate modified application approach for ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2016;27:22-30.
7. Stevenson IH, Teichtahl H, Cunnington D, et al. Prevalence of sleep disordered breathing in paroxysmal and persistent atrial fibrillation patients with normal left ventricular function. Eur Heart J. 2008;29:1662-9.
8. Fein AS, Shvilkin A, Shah D, et al. Treatment of obstructive sleep apnea reduces the risk of atrial fibrillation recurrence after catheter ablation. J Am Coll Cardiol. 2013;62:300-5.
9. Naruse Y, Tada H, Satoh M, et al. Concomitant obstructive sleep apnea increases the recurrence of atrial fibrillation following radiofrequency catheter ablation of atrial fibrillation: clinical impact of continuous positive airway pressure therapy. Heart Rhythm. 2013;10:331-7.
10. Otto M, Belohlavek M, Romero-Corral A, et al. Comparison of cardiac structural and functional changes in obese otherwise healthy adults with versus without obstructive sleep apnea. Am J Cardiol. 2007;99:1298-302.
11. Kis Z, Muka T, Franco OH, et al. The short and long-term efficacy of pulmonary vein isolation as a sole treatment strategy for paroxysmal atrial fibrillation: a systematic review and meta-analysis. Curr Cardiol Rev. 2017 Jan 17. [Epub ahead of print].
12. Nakase K, Kollmar R, Lazar J, et al. Laryngospasm, central and obstructive apnea during seizures: defining pathophysiology for sudden death in a rat model. Epilepsy Res. 2016;128:126-39.
ORLANDO – Patients with atrial fibrillation (AF) should be screened for obstructive sleep apnea (OSA), because this information may be useful in guiding ablation strategies, according to results of a prospective study.
The study, which associated OSA in AF with a high relative rate of non–pulmonary vein (PV) triggers, has contributed to the “growing body of evidence implicating sleep apnea in atrial remodeling and promotion of the AF substrate,” Elad Anter, MD, associate director of the clinical electrophysiology laboratory at Beth Israel Deaconess Medical Center, Boston, reported at the annual International AF Symposium.
Despite the close association between OSA and AF, it has been unclear whether OSA is a causative factor. Dr. Anter suggested that mechanistic association is strengthening, however.
It has been hypothesized that OSA generates AF substrate through negative intrathoracic pressure changes and autonomic nervous system activation. But Dr. Anter reported that there is more recent and compelling evidence that the repetitive occlusions produced by OSA result in remodeling of the atria, producing scar tissue that slows conduction and produces susceptibility to reentry AF.
A newly completed prospective multicenter study adds support to this latter hypothesis. In the protocol, patients with paroxysmal AF scheduled for ablation were required to undergo a sleep study, an AF mapping study, and follow-up for at least 12 months. A known history of OSA was an exclusion criterion. To isolate the effect of OSA, there were exclusions for other major etiologies for AF, such as heart failure or coronary artery disease.
The AF mapping was conducted when patients were in sinus rhythm “to evaluate the baseline atrial substrate and avoid measurements related to acute electrical remodeling,” Dr. Anter explained.
Of 172 patients initially enrolled, 133 completed the sleep study, 118 completed the mapping study, and 110 completed both and were followed for at least 12 months. Of these, 43 patients without OSA were compared with 43 patients with OSA defined as an apnea-hypopnea index (AHI) of at least 15. Patients in the two groups did not differ significantly for relevant characteristics, such as body mass index (BMI), age, presence of hypertension, or duration of AF; but the left atrial (LA) volume was significantly greater (P = .01) in those with OSA than those without.
Even though the prevalence of voltage abnormalities was higher in the OSA group for the right (P = .01) and left atria (P = .0001) before ablation, the prevalence of PV triggers (63% vs. 65%), non-PV triggers (19% vs. 12%) and noninducible triggers (19% vs. 23%) were similar.
After ablation, PV triggers were no longer inducible in either group, but there was a striking difference in inducible non-PV triggers. While only 11.6% remained inducible in the non-OSA group, 41.8% (P = .003) remained inducible in the OSA patients.
“AF triggers in OSA were most commonly located at the LA septum, at the zone of low voltage and abnormal electrograms, as determined during sinus rhythm,” Dr. Anter reported. “Ablation of these triggers at the zone of tissue abnormality in the OSA patients resulted in termination of AF in 9 (64.2%) of the 14 patients.”
Overall, at the end of 12 months, 79% of those without OSA remained in arrhythmia-free survival, versus 65.1% of the group with OSA that were treated with PV isolation alone.
The lower rate of success in the OSA group shows the importance of specifically directing ablation to the areas of low voltage and slow conduction in the left anterior septum that Dr. Anter indicated otherwise would be missed.
“These zones are a common source of extra-PV triggers and localized circuits or rotors of AF in OSA patients,” he reported. “Ablation of these low voltage zones is associated with improved clinical outcome in OSA patients with paroxysmal AF.”
The data, which Dr. Anter said are consistent with a growing body of work regarding the relationship of OSA and AF, provided the basis for suggesting that AF patients undergo routine screening for OSA.
In patients with OSA, ablation of PV triggers alone even in paroxysmal PAF “may not be sufficient,” he cautioned. “Evaluation of non-PV triggers should also be performed.”
Dr. Anter reported financial relationships with Biosense Webster and Boston Scientific.
ORLANDO – Patients with atrial fibrillation (AF) should be screened for obstructive sleep apnea (OSA), because this information may be useful in guiding ablation strategies, according to results of a prospective study.
The study, which associated OSA in AF with a high relative rate of non–pulmonary vein (PV) triggers, has contributed to the “growing body of evidence implicating sleep apnea in atrial remodeling and promotion of the AF substrate,” Elad Anter, MD, associate director of the clinical electrophysiology laboratory at Beth Israel Deaconess Medical Center, Boston, reported at the annual International AF Symposium.
Despite the close association between OSA and AF, it has been unclear whether OSA is a causative factor. Dr. Anter suggested that mechanistic association is strengthening, however.
It has been hypothesized that OSA generates AF substrate through negative intrathoracic pressure changes and autonomic nervous system activation. But Dr. Anter reported that there is more recent and compelling evidence that the repetitive occlusions produced by OSA result in remodeling of the atria, producing scar tissue that slows conduction and produces susceptibility to reentry AF.
A newly completed prospective multicenter study adds support to this latter hypothesis. In the protocol, patients with paroxysmal AF scheduled for ablation were required to undergo a sleep study, an AF mapping study, and follow-up for at least 12 months. A known history of OSA was an exclusion criterion. To isolate the effect of OSA, there were exclusions for other major etiologies for AF, such as heart failure or coronary artery disease.
The AF mapping was conducted when patients were in sinus rhythm “to evaluate the baseline atrial substrate and avoid measurements related to acute electrical remodeling,” Dr. Anter explained.
Of 172 patients initially enrolled, 133 completed the sleep study, 118 completed the mapping study, and 110 completed both and were followed for at least 12 months. Of these, 43 patients without OSA were compared with 43 patients with OSA defined as an apnea-hypopnea index (AHI) of at least 15. Patients in the two groups did not differ significantly for relevant characteristics, such as body mass index (BMI), age, presence of hypertension, or duration of AF; but the left atrial (LA) volume was significantly greater (P = .01) in those with OSA than those without.
Even though the prevalence of voltage abnormalities was higher in the OSA group for the right (P = .01) and left atria (P = .0001) before ablation, the prevalence of PV triggers (63% vs. 65%), non-PV triggers (19% vs. 12%) and noninducible triggers (19% vs. 23%) were similar.
After ablation, PV triggers were no longer inducible in either group, but there was a striking difference in inducible non-PV triggers. While only 11.6% remained inducible in the non-OSA group, 41.8% (P = .003) remained inducible in the OSA patients.
“AF triggers in OSA were most commonly located at the LA septum, at the zone of low voltage and abnormal electrograms, as determined during sinus rhythm,” Dr. Anter reported. “Ablation of these triggers at the zone of tissue abnormality in the OSA patients resulted in termination of AF in 9 (64.2%) of the 14 patients.”
Overall, at the end of 12 months, 79% of those without OSA remained in arrhythmia-free survival, versus 65.1% of the group with OSA that were treated with PV isolation alone.
The lower rate of success in the OSA group shows the importance of specifically directing ablation to the areas of low voltage and slow conduction in the left anterior septum that Dr. Anter indicated otherwise would be missed.
“These zones are a common source of extra-PV triggers and localized circuits or rotors of AF in OSA patients,” he reported. “Ablation of these low voltage zones is associated with improved clinical outcome in OSA patients with paroxysmal AF.”
The data, which Dr. Anter said are consistent with a growing body of work regarding the relationship of OSA and AF, provided the basis for suggesting that AF patients undergo routine screening for OSA.
In patients with OSA, ablation of PV triggers alone even in paroxysmal PAF “may not be sufficient,” he cautioned. “Evaluation of non-PV triggers should also be performed.”
Dr. Anter reported financial relationships with Biosense Webster and Boston Scientific.
Key clinical point: Atrial fibrillation associated with sleep apnea appears to have features that should be addressed specifically for sustained rhythm control.
Major finding: AF patients with sleep apnea have more non–pulmonary vein triggers after ablation than do those without sleep apnea (41.8% vs. 11.6%).
Data source: A prospective multicenter observational study.
Disclosures: Dr. Anter reported financial relationships with Biosense Webster and Boston Scientific.
Clinicians underusing statins, aspirin in HIV patients
NEW ORLEANS – Clinicians may not be prescribing enough statins and/or aspirin therapy for the HIV-infected population at highest risk for atherosclerotic cardiovascular disease, according to the results of a large retrospective study from an HIV clinic in New York.
“We need to shift our paradigm for care – from ‘take antiretrovirals and that’s it’ – to a focus on the whole patient and chronic conditions,” Emma Kaplan-Lewis, MD, said during a poster presentation at an annual scientific meeting on infectious diseases. Risk of cardiovascular events increases 1.5-fold among people with HIV treated with antiretroviral therapy, compared with the uninfected population, she noted.
The investigators examined prescriptions for a statin or aspirin therapy in three high-risk groups, defined by 2013 American College of Cardiology/American Heart Association guidelines and 2011 AHA/American College of Cardiology Foundation guidelines. They classified patients with an ICD-9 code indicating a history of atherosclerotic cardiovascular disease, 40- to 75-year-olds with diabetes and LDL cholesterol greater than 70 mg/dL, and those with an LDL cholesterol level greater than 190 mg/dL.
Almost two-thirds of the higher-risk patients, 141 (61%), had a history of atherosclerotic cardiovascular disease. In this cohort, 56% were prescribed statin therapy, and 100 (71%) were prescribed aspirin.
Of the 85 high-risk patients with diabetes and an LDL greater than 70 mg/dL, 48 (57%) were on statin therapy (aspirin not indicated), and of the 5 high-risk patients with an LDL cholesterol level greater than 190 mg/dL, 3 (60%) were on statin therapy, and 1 (20%) was on aspirin.
The investigators also found 37% of the higher-risk patients were active cigarette smokers. There was a trend toward lower statin use among smokers, 33% versus 44% for nonsmokers. “Smoking was not significantly associated with statin prescription, but this is a modifiable risk factor – after which they may not need a statin,” Dr. Kaplan-Lewis said.
The findings support risk-reduction interventions for people with HIV infection who are at higher risk for cardiovascular disease, Dr. Kaplan-Lewis said. The results support previous reports in the literature, including a study that found 51% of 13,579 veterans infected with HIV had an indication for statin use, but 22% of this group was not prescribed the therapy (Clin Infect Dis. 2016;63:407-13. doi: 10.1093/cid/ciw289).
In 2017, the investigators plan to share the study data with providers. “Each provider will get a list of their patients who should be on a statin. This is about awareness and making it more of a priority,” Dr. Kaplan-Lewis said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The findings of additional research assessing lower thresholds for statin use among people with HIV infection are still pending, Dr. Kaplan-Lewis added.
The study was supported in part by the New York State Department of Health Empire Clinical Research Investigator Program. Dr. Kaplan-Lewis had no relevant disclosures.
NEW ORLEANS – Clinicians may not be prescribing enough statins and/or aspirin therapy for the HIV-infected population at highest risk for atherosclerotic cardiovascular disease, according to the results of a large retrospective study from an HIV clinic in New York.
“We need to shift our paradigm for care – from ‘take antiretrovirals and that’s it’ – to a focus on the whole patient and chronic conditions,” Emma Kaplan-Lewis, MD, said during a poster presentation at an annual scientific meeting on infectious diseases. Risk of cardiovascular events increases 1.5-fold among people with HIV treated with antiretroviral therapy, compared with the uninfected population, she noted.
The investigators examined prescriptions for a statin or aspirin therapy in three high-risk groups, defined by 2013 American College of Cardiology/American Heart Association guidelines and 2011 AHA/American College of Cardiology Foundation guidelines. They classified patients with an ICD-9 code indicating a history of atherosclerotic cardiovascular disease, 40- to 75-year-olds with diabetes and LDL cholesterol greater than 70 mg/dL, and those with an LDL cholesterol level greater than 190 mg/dL.
Almost two-thirds of the higher-risk patients, 141 (61%), had a history of atherosclerotic cardiovascular disease. In this cohort, 56% were prescribed statin therapy, and 100 (71%) were prescribed aspirin.
Of the 85 high-risk patients with diabetes and an LDL greater than 70 mg/dL, 48 (57%) were on statin therapy (aspirin not indicated), and of the 5 high-risk patients with an LDL cholesterol level greater than 190 mg/dL, 3 (60%) were on statin therapy, and 1 (20%) was on aspirin.
The investigators also found 37% of the higher-risk patients were active cigarette smokers. There was a trend toward lower statin use among smokers, 33% versus 44% for nonsmokers. “Smoking was not significantly associated with statin prescription, but this is a modifiable risk factor – after which they may not need a statin,” Dr. Kaplan-Lewis said.
The findings support risk-reduction interventions for people with HIV infection who are at higher risk for cardiovascular disease, Dr. Kaplan-Lewis said. The results support previous reports in the literature, including a study that found 51% of 13,579 veterans infected with HIV had an indication for statin use, but 22% of this group was not prescribed the therapy (Clin Infect Dis. 2016;63:407-13. doi: 10.1093/cid/ciw289).
In 2017, the investigators plan to share the study data with providers. “Each provider will get a list of their patients who should be on a statin. This is about awareness and making it more of a priority,” Dr. Kaplan-Lewis said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The findings of additional research assessing lower thresholds for statin use among people with HIV infection are still pending, Dr. Kaplan-Lewis added.
The study was supported in part by the New York State Department of Health Empire Clinical Research Investigator Program. Dr. Kaplan-Lewis had no relevant disclosures.
NEW ORLEANS – Clinicians may not be prescribing enough statins and/or aspirin therapy for the HIV-infected population at highest risk for atherosclerotic cardiovascular disease, according to the results of a large retrospective study from an HIV clinic in New York.
“We need to shift our paradigm for care – from ‘take antiretrovirals and that’s it’ – to a focus on the whole patient and chronic conditions,” Emma Kaplan-Lewis, MD, said during a poster presentation at an annual scientific meeting on infectious diseases. Risk of cardiovascular events increases 1.5-fold among people with HIV treated with antiretroviral therapy, compared with the uninfected population, she noted.
The investigators examined prescriptions for a statin or aspirin therapy in three high-risk groups, defined by 2013 American College of Cardiology/American Heart Association guidelines and 2011 AHA/American College of Cardiology Foundation guidelines. They classified patients with an ICD-9 code indicating a history of atherosclerotic cardiovascular disease, 40- to 75-year-olds with diabetes and LDL cholesterol greater than 70 mg/dL, and those with an LDL cholesterol level greater than 190 mg/dL.
Almost two-thirds of the higher-risk patients, 141 (61%), had a history of atherosclerotic cardiovascular disease. In this cohort, 56% were prescribed statin therapy, and 100 (71%) were prescribed aspirin.
Of the 85 high-risk patients with diabetes and an LDL greater than 70 mg/dL, 48 (57%) were on statin therapy (aspirin not indicated), and of the 5 high-risk patients with an LDL cholesterol level greater than 190 mg/dL, 3 (60%) were on statin therapy, and 1 (20%) was on aspirin.
The investigators also found 37% of the higher-risk patients were active cigarette smokers. There was a trend toward lower statin use among smokers, 33% versus 44% for nonsmokers. “Smoking was not significantly associated with statin prescription, but this is a modifiable risk factor – after which they may not need a statin,” Dr. Kaplan-Lewis said.
The findings support risk-reduction interventions for people with HIV infection who are at higher risk for cardiovascular disease, Dr. Kaplan-Lewis said. The results support previous reports in the literature, including a study that found 51% of 13,579 veterans infected with HIV had an indication for statin use, but 22% of this group was not prescribed the therapy (Clin Infect Dis. 2016;63:407-13. doi: 10.1093/cid/ciw289).
In 2017, the investigators plan to share the study data with providers. “Each provider will get a list of their patients who should be on a statin. This is about awareness and making it more of a priority,” Dr. Kaplan-Lewis said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The findings of additional research assessing lower thresholds for statin use among people with HIV infection are still pending, Dr. Kaplan-Lewis added.
The study was supported in part by the New York State Department of Health Empire Clinical Research Investigator Program. Dr. Kaplan-Lewis had no relevant disclosures.
AT IDWEEK 2016
Key clinical point: Statins and aspirin therapy are underutilized in a proportion of the HIV positive population at higher risk for cardiovascular disease.
Major finding: Of the 141 high-risk people with HIV infection and a history of atherosclerotic cardiovascular disease, only 56% were prescribed a statin and 71% were prescribed aspirin.
Data source: Poster presentation at IDWeek 2016.
Disclosures: The study was supported in part by the New York State Department of Health Empire Clinical Research Investigator Program. Dr. Kaplan-Lewis had no relevant disclosures.
HHS Secretary-nominee avoids specifics on Medicaid funding during second hearing
WASHINGTON – Rep. Tom Price, MD (R-Ga.), dodged specifics on Medicaid reform and the issue of block grants for funding Medicaid during a hearing Jan. 24 before the Senate Financing Committee.
The committee will be voting to move forward to the full Senate his nomination as secretary of the Department of Health & Human Services.
Sen. Robert Casey (D-Penn.) queried Rep. Price about guarantees as to whether people with disabilities covered by Medicaid would continue to be covered under a block grant program. Rep. Price responded that the “metrics that we will use ... [are] the quality of care and whether or not they are receiving that care.”
Rep. Price added that he is committed “to make it so they have that [current level of existing] coverage or greater.” Sen. Casey questioned whether that goal could be achieved, considering the amount of funding that could potentially be lost to a block grant program.
When further pressed on the 2017 budget he prepared as House Budget Committee chairman that included block grants for Medicaid, Rep. Price would not state clearly his promotion of the concept. Instead, he said he was committed to creating a system that is affordable, accessible, of high quality, and responsive to patient needs, as well as one that incentivizes innovation and provides choice.
Rep. Price was also pressed on his advocacy of high-risk pools, particularly for those who have high-cost, preexisting conditions and might not be able to get coverage in other areas of the reformed market. He voiced his support for such pools as well as for pools that would allow people without a common economic link, such as an employer, to band together for insurance coverage.
Sen. Debbie Stabenow (D-Mich.) noted that the history of high-risk pools has been less than stellar, with insurance rates typically 150%-200% higher than the rates of other plans and, typically, lifetime caps on coverage.
Rep. Price additionally called for a “better” system that puts patients at the center of health care decisions. In response to discussion with Sen. Chuck Grassley (R-Iowa), Rep. Price said transparency, specifically in relation to the Physician Payments Sunshine Act, was “vital,” and expanded the notion of transparency to include outcomes and pricing so that patients could have the best information to make decisions about their own health care.
It is “virtually impossible” for patients to know their true health care costs, Rep. Price said. To be informed, patients need better outcome measures, which would be “a priority” if he is confirmed as secretary.
Rep. Price also agreed that the Children’s Health Insurance Plan should be extended, and when asked about extending the program for 5 years, he responded that “8 years would be better.”
In the area of mental health, he suggested treatment models similar to those used to address physical health.
Rep. Price was not grilled on his investments at the Finance Committee hearing as he was at the Health, Education, Labor and Pensions Committee hearing, where he maintained he did nothing unethical or against the rules of the Senate.
Separate from the hearing, eight Democratic senators, led by Ranking Member Patty Murray of Washington, sent a Jan. 23 letter to the U.S. Securities and Exchange Commission to investigate whether Rep. Price potentially engaged in insider trading or other violations in relation to his specific purchase of stock in Innate Immunotherapeutics.
WASHINGTON – Rep. Tom Price, MD (R-Ga.), dodged specifics on Medicaid reform and the issue of block grants for funding Medicaid during a hearing Jan. 24 before the Senate Financing Committee.
The committee will be voting to move forward to the full Senate his nomination as secretary of the Department of Health & Human Services.
Sen. Robert Casey (D-Penn.) queried Rep. Price about guarantees as to whether people with disabilities covered by Medicaid would continue to be covered under a block grant program. Rep. Price responded that the “metrics that we will use ... [are] the quality of care and whether or not they are receiving that care.”
Rep. Price added that he is committed “to make it so they have that [current level of existing] coverage or greater.” Sen. Casey questioned whether that goal could be achieved, considering the amount of funding that could potentially be lost to a block grant program.
When further pressed on the 2017 budget he prepared as House Budget Committee chairman that included block grants for Medicaid, Rep. Price would not state clearly his promotion of the concept. Instead, he said he was committed to creating a system that is affordable, accessible, of high quality, and responsive to patient needs, as well as one that incentivizes innovation and provides choice.
Rep. Price was also pressed on his advocacy of high-risk pools, particularly for those who have high-cost, preexisting conditions and might not be able to get coverage in other areas of the reformed market. He voiced his support for such pools as well as for pools that would allow people without a common economic link, such as an employer, to band together for insurance coverage.
Sen. Debbie Stabenow (D-Mich.) noted that the history of high-risk pools has been less than stellar, with insurance rates typically 150%-200% higher than the rates of other plans and, typically, lifetime caps on coverage.
Rep. Price additionally called for a “better” system that puts patients at the center of health care decisions. In response to discussion with Sen. Chuck Grassley (R-Iowa), Rep. Price said transparency, specifically in relation to the Physician Payments Sunshine Act, was “vital,” and expanded the notion of transparency to include outcomes and pricing so that patients could have the best information to make decisions about their own health care.
It is “virtually impossible” for patients to know their true health care costs, Rep. Price said. To be informed, patients need better outcome measures, which would be “a priority” if he is confirmed as secretary.
Rep. Price also agreed that the Children’s Health Insurance Plan should be extended, and when asked about extending the program for 5 years, he responded that “8 years would be better.”
In the area of mental health, he suggested treatment models similar to those used to address physical health.
Rep. Price was not grilled on his investments at the Finance Committee hearing as he was at the Health, Education, Labor and Pensions Committee hearing, where he maintained he did nothing unethical or against the rules of the Senate.
Separate from the hearing, eight Democratic senators, led by Ranking Member Patty Murray of Washington, sent a Jan. 23 letter to the U.S. Securities and Exchange Commission to investigate whether Rep. Price potentially engaged in insider trading or other violations in relation to his specific purchase of stock in Innate Immunotherapeutics.
WASHINGTON – Rep. Tom Price, MD (R-Ga.), dodged specifics on Medicaid reform and the issue of block grants for funding Medicaid during a hearing Jan. 24 before the Senate Financing Committee.
The committee will be voting to move forward to the full Senate his nomination as secretary of the Department of Health & Human Services.
Sen. Robert Casey (D-Penn.) queried Rep. Price about guarantees as to whether people with disabilities covered by Medicaid would continue to be covered under a block grant program. Rep. Price responded that the “metrics that we will use ... [are] the quality of care and whether or not they are receiving that care.”
Rep. Price added that he is committed “to make it so they have that [current level of existing] coverage or greater.” Sen. Casey questioned whether that goal could be achieved, considering the amount of funding that could potentially be lost to a block grant program.
When further pressed on the 2017 budget he prepared as House Budget Committee chairman that included block grants for Medicaid, Rep. Price would not state clearly his promotion of the concept. Instead, he said he was committed to creating a system that is affordable, accessible, of high quality, and responsive to patient needs, as well as one that incentivizes innovation and provides choice.
Rep. Price was also pressed on his advocacy of high-risk pools, particularly for those who have high-cost, preexisting conditions and might not be able to get coverage in other areas of the reformed market. He voiced his support for such pools as well as for pools that would allow people without a common economic link, such as an employer, to band together for insurance coverage.
Sen. Debbie Stabenow (D-Mich.) noted that the history of high-risk pools has been less than stellar, with insurance rates typically 150%-200% higher than the rates of other plans and, typically, lifetime caps on coverage.
Rep. Price additionally called for a “better” system that puts patients at the center of health care decisions. In response to discussion with Sen. Chuck Grassley (R-Iowa), Rep. Price said transparency, specifically in relation to the Physician Payments Sunshine Act, was “vital,” and expanded the notion of transparency to include outcomes and pricing so that patients could have the best information to make decisions about their own health care.
It is “virtually impossible” for patients to know their true health care costs, Rep. Price said. To be informed, patients need better outcome measures, which would be “a priority” if he is confirmed as secretary.
Rep. Price also agreed that the Children’s Health Insurance Plan should be extended, and when asked about extending the program for 5 years, he responded that “8 years would be better.”
In the area of mental health, he suggested treatment models similar to those used to address physical health.
Rep. Price was not grilled on his investments at the Finance Committee hearing as he was at the Health, Education, Labor and Pensions Committee hearing, where he maintained he did nothing unethical or against the rules of the Senate.
Separate from the hearing, eight Democratic senators, led by Ranking Member Patty Murray of Washington, sent a Jan. 23 letter to the U.S. Securities and Exchange Commission to investigate whether Rep. Price potentially engaged in insider trading or other violations in relation to his specific purchase of stock in Innate Immunotherapeutics.
One GOP plan says states that like their Obamacare can keep it
Some states could keep their federally funded insurance exchange with consumer protections intact under a proposal unveiled Monday by two Republican U.S. senators.
Sen. Bill Cassidy (R-La.) and Sen. Susan Collins (R-Maine) said their proposed legislation would allow states that embraced the Affordable Care Act to keep operating under many of the current federal rules.
Another option is for states to pursue a less-regulated alternative to Obamacare under the Patient Freedom Act. Or they could reject federal dollars completely in favor of a new state solution for health coverage.
“We give states the option,” Sen. Cassidy said at press conference Jan. 23.
Some health law supporters say the Cassidy-Collins proposal, one of several in the GOP-controlled Congress, could represent a lifeline for states such as California that have invested heavily in expanding coverage under the ACA.
But many Democrats at the state and national level criticized the plan as potentially harmful to millions of Americans who rely on the health law because it does not promise sufficient funding and consumer protections.
“It provides a somewhat illusory option to stay in the ACA without the guarantee of federal assistance necessary to allow states to maintain the level of coverage they are currently providing,” California Insurance Commissioner Dave Jones, an elected Democrat, said in an interview.
California fully implemented the health law by expanding Medicaid coverage to millions of low-income people and creating its own insurance exchange, which ultimately covered 1.3 million enrollees. Supporters have held the state up as proof that the health law can work as intended – and as a counterpoint to Republican contentions that Obamacare is collapsing nationally.
Sen. Cassidy said his legislation promotes the Republican doctrine of states’ rights while avoiding the one-size-fits-all approach from Washington.
Sen. Collins echoed that sentiment, saying she favors letting states that had success with the health law maintain the status quo. She described it as “reimplementation of the ACA” in those states.
“If a state chooses to remain covered by the ACA, exchange policies will continue to be eligible for cost-sharing subsidies and advance premium tax credits,” she said in a Senate floor speech Jan. 23. “The insurance market will still be subject to ACA requirements, and the individual mandate and employer mandate will also remain in place in that state.”
Sen. Cassidy and Sen. Collins acknowledged that details of their bill haven’t been worked out, nor is it clear how it will mesh with other proposals. Competing plans in Congress don’t envision these state options, and it’s unclear what approach President Donald Trump and his nascent administration will take in crafting a replacement plan.
Still, some industry experts and analysts say the Cassidy-Collins proposal is intriguing.
“The advantage to a state like California is we could protect what we have accomplished already,” said Howard Kahn, former chief executive of L.A. Care Health Plan, an insurer on the Covered California exchange. The large managed care plan serves patients in Medi-Cal, the state’s Medicaid program.
“Cassidy’s proposal could work for California better than other alternatives in the short term. The question is whether they maintain federal funding for the longer term,” Mr. Kahn said. “My feeling is you do have to engage with the rational Republicans who are trying to find something that doesn’t tear it all apart.”
Federal funding is a key issue for states. In a summary of the bill posted by Sen. Collins, it said states choosing to retain Obamacare or pick the Republican alternative could receive “funding equal to 95% of federal premium tax credits and cost-sharing subsidies, as well as the federal match for Medicaid expansion.”
Dylan H. Roby, of the department of health services administration at the University of Maryland School of Public Health, College Park, said “California would still have to absorb a 5% cut, at least, in the premium tax credits and cost-sharing subsidies.”
Republicans will need 60 votes in the U.S. Senate to pass a full replacement for the ACA. Sen. Cassidy said his compromise approach is designed to win over some Democrats and reach that 60-vote majority.
In her speech on the Senate floor, Sen. Collins said children could still stay on their parents’ health plans until they are 26 years old. There would be no discrimination against preexisting conditions and no caps on annual or lifetime coverage, she said.
Other key features of the legislation include a provision allowing states to automatically enroll eligible people in health plans unless they opt out. The plan also promotes health savings accounts and price transparency requiring hospitals and other providers to disclose costs so consumers can shop around for the best price.
This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
Some states could keep their federally funded insurance exchange with consumer protections intact under a proposal unveiled Monday by two Republican U.S. senators.
Sen. Bill Cassidy (R-La.) and Sen. Susan Collins (R-Maine) said their proposed legislation would allow states that embraced the Affordable Care Act to keep operating under many of the current federal rules.
Another option is for states to pursue a less-regulated alternative to Obamacare under the Patient Freedom Act. Or they could reject federal dollars completely in favor of a new state solution for health coverage.
“We give states the option,” Sen. Cassidy said at press conference Jan. 23.
Some health law supporters say the Cassidy-Collins proposal, one of several in the GOP-controlled Congress, could represent a lifeline for states such as California that have invested heavily in expanding coverage under the ACA.
But many Democrats at the state and national level criticized the plan as potentially harmful to millions of Americans who rely on the health law because it does not promise sufficient funding and consumer protections.
“It provides a somewhat illusory option to stay in the ACA without the guarantee of federal assistance necessary to allow states to maintain the level of coverage they are currently providing,” California Insurance Commissioner Dave Jones, an elected Democrat, said in an interview.
California fully implemented the health law by expanding Medicaid coverage to millions of low-income people and creating its own insurance exchange, which ultimately covered 1.3 million enrollees. Supporters have held the state up as proof that the health law can work as intended – and as a counterpoint to Republican contentions that Obamacare is collapsing nationally.
Sen. Cassidy said his legislation promotes the Republican doctrine of states’ rights while avoiding the one-size-fits-all approach from Washington.
Sen. Collins echoed that sentiment, saying she favors letting states that had success with the health law maintain the status quo. She described it as “reimplementation of the ACA” in those states.
“If a state chooses to remain covered by the ACA, exchange policies will continue to be eligible for cost-sharing subsidies and advance premium tax credits,” she said in a Senate floor speech Jan. 23. “The insurance market will still be subject to ACA requirements, and the individual mandate and employer mandate will also remain in place in that state.”
Sen. Cassidy and Sen. Collins acknowledged that details of their bill haven’t been worked out, nor is it clear how it will mesh with other proposals. Competing plans in Congress don’t envision these state options, and it’s unclear what approach President Donald Trump and his nascent administration will take in crafting a replacement plan.
Still, some industry experts and analysts say the Cassidy-Collins proposal is intriguing.
“The advantage to a state like California is we could protect what we have accomplished already,” said Howard Kahn, former chief executive of L.A. Care Health Plan, an insurer on the Covered California exchange. The large managed care plan serves patients in Medi-Cal, the state’s Medicaid program.
“Cassidy’s proposal could work for California better than other alternatives in the short term. The question is whether they maintain federal funding for the longer term,” Mr. Kahn said. “My feeling is you do have to engage with the rational Republicans who are trying to find something that doesn’t tear it all apart.”
Federal funding is a key issue for states. In a summary of the bill posted by Sen. Collins, it said states choosing to retain Obamacare or pick the Republican alternative could receive “funding equal to 95% of federal premium tax credits and cost-sharing subsidies, as well as the federal match for Medicaid expansion.”
Dylan H. Roby, of the department of health services administration at the University of Maryland School of Public Health, College Park, said “California would still have to absorb a 5% cut, at least, in the premium tax credits and cost-sharing subsidies.”
Republicans will need 60 votes in the U.S. Senate to pass a full replacement for the ACA. Sen. Cassidy said his compromise approach is designed to win over some Democrats and reach that 60-vote majority.
In her speech on the Senate floor, Sen. Collins said children could still stay on their parents’ health plans until they are 26 years old. There would be no discrimination against preexisting conditions and no caps on annual or lifetime coverage, she said.
Other key features of the legislation include a provision allowing states to automatically enroll eligible people in health plans unless they opt out. The plan also promotes health savings accounts and price transparency requiring hospitals and other providers to disclose costs so consumers can shop around for the best price.
This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
Some states could keep their federally funded insurance exchange with consumer protections intact under a proposal unveiled Monday by two Republican U.S. senators.
Sen. Bill Cassidy (R-La.) and Sen. Susan Collins (R-Maine) said their proposed legislation would allow states that embraced the Affordable Care Act to keep operating under many of the current federal rules.
Another option is for states to pursue a less-regulated alternative to Obamacare under the Patient Freedom Act. Or they could reject federal dollars completely in favor of a new state solution for health coverage.
“We give states the option,” Sen. Cassidy said at press conference Jan. 23.
Some health law supporters say the Cassidy-Collins proposal, one of several in the GOP-controlled Congress, could represent a lifeline for states such as California that have invested heavily in expanding coverage under the ACA.
But many Democrats at the state and national level criticized the plan as potentially harmful to millions of Americans who rely on the health law because it does not promise sufficient funding and consumer protections.
“It provides a somewhat illusory option to stay in the ACA without the guarantee of federal assistance necessary to allow states to maintain the level of coverage they are currently providing,” California Insurance Commissioner Dave Jones, an elected Democrat, said in an interview.
California fully implemented the health law by expanding Medicaid coverage to millions of low-income people and creating its own insurance exchange, which ultimately covered 1.3 million enrollees. Supporters have held the state up as proof that the health law can work as intended – and as a counterpoint to Republican contentions that Obamacare is collapsing nationally.
Sen. Cassidy said his legislation promotes the Republican doctrine of states’ rights while avoiding the one-size-fits-all approach from Washington.
Sen. Collins echoed that sentiment, saying she favors letting states that had success with the health law maintain the status quo. She described it as “reimplementation of the ACA” in those states.
“If a state chooses to remain covered by the ACA, exchange policies will continue to be eligible for cost-sharing subsidies and advance premium tax credits,” she said in a Senate floor speech Jan. 23. “The insurance market will still be subject to ACA requirements, and the individual mandate and employer mandate will also remain in place in that state.”
Sen. Cassidy and Sen. Collins acknowledged that details of their bill haven’t been worked out, nor is it clear how it will mesh with other proposals. Competing plans in Congress don’t envision these state options, and it’s unclear what approach President Donald Trump and his nascent administration will take in crafting a replacement plan.
Still, some industry experts and analysts say the Cassidy-Collins proposal is intriguing.
“The advantage to a state like California is we could protect what we have accomplished already,” said Howard Kahn, former chief executive of L.A. Care Health Plan, an insurer on the Covered California exchange. The large managed care plan serves patients in Medi-Cal, the state’s Medicaid program.
“Cassidy’s proposal could work for California better than other alternatives in the short term. The question is whether they maintain federal funding for the longer term,” Mr. Kahn said. “My feeling is you do have to engage with the rational Republicans who are trying to find something that doesn’t tear it all apart.”
Federal funding is a key issue for states. In a summary of the bill posted by Sen. Collins, it said states choosing to retain Obamacare or pick the Republican alternative could receive “funding equal to 95% of federal premium tax credits and cost-sharing subsidies, as well as the federal match for Medicaid expansion.”
Dylan H. Roby, of the department of health services administration at the University of Maryland School of Public Health, College Park, said “California would still have to absorb a 5% cut, at least, in the premium tax credits and cost-sharing subsidies.”
Republicans will need 60 votes in the U.S. Senate to pass a full replacement for the ACA. Sen. Cassidy said his compromise approach is designed to win over some Democrats and reach that 60-vote majority.
In her speech on the Senate floor, Sen. Collins said children could still stay on their parents’ health plans until they are 26 years old. There would be no discrimination against preexisting conditions and no caps on annual or lifetime coverage, she said.
Other key features of the legislation include a provision allowing states to automatically enroll eligible people in health plans unless they opt out. The plan also promotes health savings accounts and price transparency requiring hospitals and other providers to disclose costs so consumers can shop around for the best price.
This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
USPSTF punts on sleep apnea screening
because the current evidence is inadequate to assess the benefits and harms of doing so, according to a Recommendation Statement published online Jan. 23 in JAMA.
The USPSTF makes recommendations about the effectiveness of specific health care services for patients who don’t have related signs or symptoms. In this case, the Recommendation Statement addresses adults who don’t snore excessively; gasp or choke while sleeping; or report the daytime sleepiness, impaired cognition, or mood changes typically associated with obstructive sleep apnea, said Kirsten Bobbins-Domingo, PhD, MD, chair of the organization and lead author of the Recommendation Statement, and her associates (JAMA 2017 Jan 23. doi: 10.1001/jama.2016.20325).
The USPSTF commissioned a comprehensive review of the literature to examine whether screening such patients by primary caregivers would effectively identify those who have obstructive sleep apnea and lead to treatment that would prevent the elevated rates of death, cognitive impairment, motor vehicle crashes, cardiovascular events, and cerebrovascular events related to the disorder. Daniel E. Jonas, MD, of the University of North Carolina at Chapel Hill and his associates reviewed 110 relevant studies involving 46,188 participants.
They found that the accuracy and clinical utility of numerous OSA screening tools was uncertain. In particular, the Epworth Sleepiness Scale, the STOP (Snoring, Tiredness, Observed Apnea, and High Blood Pressure) questionnaire, the STOP-BANG (STOP plus BMI, Age, Neck Circumference, and Gender) questionnaire, the Berlin Questionnaire, the Wisconsin Sleep Questionnaire, and the Multivariable Apnea Prediction (MVAP) tool have not been adequately validated in primary care settings.
Moreover, no studies directly assessed whether screening had an impact on actual health outcomes. Several treatments, notably CPAP and mandibular advancement devices, did improve intermediate outcomes such as scores on the apnea-hypopnea index, scores on the Epworth Sleepiness Scale, and blood pressure levels, but the evidence did not show that this in turn improved mortality, cardiovascular events, or the other “hard” outcomes of interest, Dr. Jonas and his associates said in their Evidence Report (JAMA 2017 Jan 23. doi: 10.1001/jama.2016.19635).
Dr. Bobbins-Domingo and her associates on the task force noted that this Recommendation Statement is consistent with that of the American Academy of Family Physicians, which also concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening asymptomatic adults for obstructive sleep apnea.
The American College of Physicians offers a “weak” recommendation based on low-quality evidence that patients with unexplained daytime sleepiness and patients suspected of having apnea undergo a sleep study, said Dr. Bobbins-Domingo, professor of medicine at the University of California, San Francisco, and her associates.
In contrast, the American Academy of Sleep Medicine recommends that routine health visits should include questions about OSA and evaluation of risk factors such as obesity, retrognathia, and treatment-refractory hypertension. If there are positive findings, a comprehensive sleep evaluation should follow, according to the AASM.
The USPSTF is an independent voluntary group supported by the Agency for Healthcare Research and Quality as mandated by the U.S. Congress. The authors’ conflict of interest disclosures are available at www.uspreventiveservicestaskforce.org.
This recommendation must not be misinterpreted. If clinicians are discouraged from directly questioning patients about apnea signs and symptoms or from using short screening questionnaires to identify those at high risk for the disorder, it would negatively influence public health.
Susan Redline, MD, is at the Sleep Health Institute and in the Division of Sleep and Circadian Disorders at Brigham and Women’s Hospital and Harvard Medical School and Beth Israel Deaconess Medical Center, all in Boston. She reported ties to Jazz Pharmaceuticals, RosMed Inc., and the Beckman Company, as well as serving on the American Academy of Sleep Medicine’s board of directors. Dr. Redline made these remarks in an editorial accompanying the USPSTF reports (JAMA 2017;317:368-70).
This recommendation must not be misinterpreted. If clinicians are discouraged from directly questioning patients about apnea signs and symptoms or from using short screening questionnaires to identify those at high risk for the disorder, it would negatively influence public health.
Susan Redline, MD, is at the Sleep Health Institute and in the Division of Sleep and Circadian Disorders at Brigham and Women’s Hospital and Harvard Medical School and Beth Israel Deaconess Medical Center, all in Boston. She reported ties to Jazz Pharmaceuticals, RosMed Inc., and the Beckman Company, as well as serving on the American Academy of Sleep Medicine’s board of directors. Dr. Redline made these remarks in an editorial accompanying the USPSTF reports (JAMA 2017;317:368-70).
This recommendation must not be misinterpreted. If clinicians are discouraged from directly questioning patients about apnea signs and symptoms or from using short screening questionnaires to identify those at high risk for the disorder, it would negatively influence public health.
Susan Redline, MD, is at the Sleep Health Institute and in the Division of Sleep and Circadian Disorders at Brigham and Women’s Hospital and Harvard Medical School and Beth Israel Deaconess Medical Center, all in Boston. She reported ties to Jazz Pharmaceuticals, RosMed Inc., and the Beckman Company, as well as serving on the American Academy of Sleep Medicine’s board of directors. Dr. Redline made these remarks in an editorial accompanying the USPSTF reports (JAMA 2017;317:368-70).
because the current evidence is inadequate to assess the benefits and harms of doing so, according to a Recommendation Statement published online Jan. 23 in JAMA.
The USPSTF makes recommendations about the effectiveness of specific health care services for patients who don’t have related signs or symptoms. In this case, the Recommendation Statement addresses adults who don’t snore excessively; gasp or choke while sleeping; or report the daytime sleepiness, impaired cognition, or mood changes typically associated with obstructive sleep apnea, said Kirsten Bobbins-Domingo, PhD, MD, chair of the organization and lead author of the Recommendation Statement, and her associates (JAMA 2017 Jan 23. doi: 10.1001/jama.2016.20325).
The USPSTF commissioned a comprehensive review of the literature to examine whether screening such patients by primary caregivers would effectively identify those who have obstructive sleep apnea and lead to treatment that would prevent the elevated rates of death, cognitive impairment, motor vehicle crashes, cardiovascular events, and cerebrovascular events related to the disorder. Daniel E. Jonas, MD, of the University of North Carolina at Chapel Hill and his associates reviewed 110 relevant studies involving 46,188 participants.
They found that the accuracy and clinical utility of numerous OSA screening tools was uncertain. In particular, the Epworth Sleepiness Scale, the STOP (Snoring, Tiredness, Observed Apnea, and High Blood Pressure) questionnaire, the STOP-BANG (STOP plus BMI, Age, Neck Circumference, and Gender) questionnaire, the Berlin Questionnaire, the Wisconsin Sleep Questionnaire, and the Multivariable Apnea Prediction (MVAP) tool have not been adequately validated in primary care settings.
Moreover, no studies directly assessed whether screening had an impact on actual health outcomes. Several treatments, notably CPAP and mandibular advancement devices, did improve intermediate outcomes such as scores on the apnea-hypopnea index, scores on the Epworth Sleepiness Scale, and blood pressure levels, but the evidence did not show that this in turn improved mortality, cardiovascular events, or the other “hard” outcomes of interest, Dr. Jonas and his associates said in their Evidence Report (JAMA 2017 Jan 23. doi: 10.1001/jama.2016.19635).
Dr. Bobbins-Domingo and her associates on the task force noted that this Recommendation Statement is consistent with that of the American Academy of Family Physicians, which also concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening asymptomatic adults for obstructive sleep apnea.
The American College of Physicians offers a “weak” recommendation based on low-quality evidence that patients with unexplained daytime sleepiness and patients suspected of having apnea undergo a sleep study, said Dr. Bobbins-Domingo, professor of medicine at the University of California, San Francisco, and her associates.
In contrast, the American Academy of Sleep Medicine recommends that routine health visits should include questions about OSA and evaluation of risk factors such as obesity, retrognathia, and treatment-refractory hypertension. If there are positive findings, a comprehensive sleep evaluation should follow, according to the AASM.
The USPSTF is an independent voluntary group supported by the Agency for Healthcare Research and Quality as mandated by the U.S. Congress. The authors’ conflict of interest disclosures are available at www.uspreventiveservicestaskforce.org.
because the current evidence is inadequate to assess the benefits and harms of doing so, according to a Recommendation Statement published online Jan. 23 in JAMA.
The USPSTF makes recommendations about the effectiveness of specific health care services for patients who don’t have related signs or symptoms. In this case, the Recommendation Statement addresses adults who don’t snore excessively; gasp or choke while sleeping; or report the daytime sleepiness, impaired cognition, or mood changes typically associated with obstructive sleep apnea, said Kirsten Bobbins-Domingo, PhD, MD, chair of the organization and lead author of the Recommendation Statement, and her associates (JAMA 2017 Jan 23. doi: 10.1001/jama.2016.20325).
The USPSTF commissioned a comprehensive review of the literature to examine whether screening such patients by primary caregivers would effectively identify those who have obstructive sleep apnea and lead to treatment that would prevent the elevated rates of death, cognitive impairment, motor vehicle crashes, cardiovascular events, and cerebrovascular events related to the disorder. Daniel E. Jonas, MD, of the University of North Carolina at Chapel Hill and his associates reviewed 110 relevant studies involving 46,188 participants.
They found that the accuracy and clinical utility of numerous OSA screening tools was uncertain. In particular, the Epworth Sleepiness Scale, the STOP (Snoring, Tiredness, Observed Apnea, and High Blood Pressure) questionnaire, the STOP-BANG (STOP plus BMI, Age, Neck Circumference, and Gender) questionnaire, the Berlin Questionnaire, the Wisconsin Sleep Questionnaire, and the Multivariable Apnea Prediction (MVAP) tool have not been adequately validated in primary care settings.
Moreover, no studies directly assessed whether screening had an impact on actual health outcomes. Several treatments, notably CPAP and mandibular advancement devices, did improve intermediate outcomes such as scores on the apnea-hypopnea index, scores on the Epworth Sleepiness Scale, and blood pressure levels, but the evidence did not show that this in turn improved mortality, cardiovascular events, or the other “hard” outcomes of interest, Dr. Jonas and his associates said in their Evidence Report (JAMA 2017 Jan 23. doi: 10.1001/jama.2016.19635).
Dr. Bobbins-Domingo and her associates on the task force noted that this Recommendation Statement is consistent with that of the American Academy of Family Physicians, which also concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening asymptomatic adults for obstructive sleep apnea.
The American College of Physicians offers a “weak” recommendation based on low-quality evidence that patients with unexplained daytime sleepiness and patients suspected of having apnea undergo a sleep study, said Dr. Bobbins-Domingo, professor of medicine at the University of California, San Francisco, and her associates.
In contrast, the American Academy of Sleep Medicine recommends that routine health visits should include questions about OSA and evaluation of risk factors such as obesity, retrognathia, and treatment-refractory hypertension. If there are positive findings, a comprehensive sleep evaluation should follow, according to the AASM.
The USPSTF is an independent voluntary group supported by the Agency for Healthcare Research and Quality as mandated by the U.S. Congress. The authors’ conflict of interest disclosures are available at www.uspreventiveservicestaskforce.org.
FROM JAMA
Cardiac events after NSCLC radiotherapy occur early
Cardiac events are “relatively common,” affecting 23% of patients, and occur earlier than previously thought following radiotherapy for non–small-cell lung cancer (NSCLC), according to a report in the Journal of Clinical Oncology.
Radiation-associated cardiac toxicity has long been recognized in patients treated for other thoracic cancers, but the conventional wisdom has been that it isn’t a consideration in patients with stage III NSCLC because “there are few long-term survivors to experience toxicity, given the typically long latency of radiotherapy-associated heart injury and the poor prognosis” of this cancer. However, the findings “challenge the perception that minimizing heart dose is not important in the treatment of patients with stage III NSCLC,” said Kyle Wang, MD, of University of North Carolina Hospitals, Chapel Hill, and his associates.
“Our data support minimization of heart radiation exposure whenever possible to doses lower than commonly recommended in patients with stage III NSCLC, to reduce risks of [cardiac] toxicity,” they noted.
Dr. Wang and his associates performed a retrospective post hoc analysis of data pooled from six prospective phase I and II trials that the University of North Carolina was involved in between 1996 and 2009. The studies assessed both dose-escalated radiotherapy and various chemotherapeutic regimens in 112 patients who were followed for a median of 8.8 years (range, 2.3-17.3 years). All the patients received induction chemotherapy, 90% received concurrent chemotherapy, and 25% received consolidation chemotherapy.
A total of 26 patients (23%) had at least one symptomatic cardiac event following radiotherapy: pericardial effusion (7 patients), MI (5 patients), unstable angina (3 patients), pericarditis (2 patients), significant arrhythmia (12 patients), and heart failure (1 patient). After the data were adjusted to account for competing risks of death, the 2-year rate of symptomatic cardiac toxicity was 10% and the 4-year rate was 18%. The first adverse cardiac event occurred at a median of 26 months (range, 1-84 months).
The risk of cardiac toxicities rose with increasing radiation exposure: At 2 years, the rate of cardiac events was 4% for those exposed to less than 10 Gy, 7% for those exposed to 10-20 Gy, and 21% for those exposed to greater than 20 Gy. At 4 years, those rates were 4%, 13%, and 41%, respectively. Patients whose hearts were exposed to greater than 20 Gy had a significantly higher rate of cardiac events than did those exposed to less than 10 Gy (HR, 5.47) or to 10-20 Gy (HR, 2.76).
Even though the prognosis may be poor in patients with stage III NSCLC, “they generally receive higher heart doses and may also have more comorbidities and smoking history, thus increasing risk and perhaps shortening the latency between radiotherapy and resultant heart disease,” Dr. Wang and his associates said (J Clin Oncol. 2017 Jan 23 [doi: 10.1200/JCO.2016.70.0229]).
“In our opinion, tumor coverage should rarely be compromised to meet a heart dose constraint. However, it would be reasonable to try to limit heart mean dose to less than 20 Gy (lower if possible) on the basis of the high event rate we observed in patients exceeding this dose (21% at 2 years and 41% at 4 years). Sophisticated radiation treatment planning techniques (e.g., [intensity-modulated radiation therapy]) and charged-particle therapy with protons or carbon ions may provide increased flexibility to generate more conformal treatment plans and reduce heart dose, which could potentially improve the clinical outcomes in patients with stage III NSCLC,” they added.
This is the first report to clearly associate radiation doses with clinically significant cardiac events in patients with locally advanced NSCLC treated with modern radiotherapy techniques, and it suggests that these events happen much earlier than conventionally believed.
Perhaps cardiac risk didn’t matter so much when, historically, the life expectancy of this patient population was only 2 years. But given the improvements in survival over the last 2 decades, together with the findings of Wang et al., the era of indiscriminate irradiation to the heart should end.
Charles B. Simone II, MD, is at the University of Maryland Medical Center, Baltimore. He reported having no relevant financial disclosures. Dr. Simone made these remarks in an editorial accompanying Dr. Wang’s report (J Clin Oncol. 2017 January 23 [doi: 10.1200/JCO.2016.71.5581]).
This is the first report to clearly associate radiation doses with clinically significant cardiac events in patients with locally advanced NSCLC treated with modern radiotherapy techniques, and it suggests that these events happen much earlier than conventionally believed.
Perhaps cardiac risk didn’t matter so much when, historically, the life expectancy of this patient population was only 2 years. But given the improvements in survival over the last 2 decades, together with the findings of Wang et al., the era of indiscriminate irradiation to the heart should end.
Charles B. Simone II, MD, is at the University of Maryland Medical Center, Baltimore. He reported having no relevant financial disclosures. Dr. Simone made these remarks in an editorial accompanying Dr. Wang’s report (J Clin Oncol. 2017 January 23 [doi: 10.1200/JCO.2016.71.5581]).
This is the first report to clearly associate radiation doses with clinically significant cardiac events in patients with locally advanced NSCLC treated with modern radiotherapy techniques, and it suggests that these events happen much earlier than conventionally believed.
Perhaps cardiac risk didn’t matter so much when, historically, the life expectancy of this patient population was only 2 years. But given the improvements in survival over the last 2 decades, together with the findings of Wang et al., the era of indiscriminate irradiation to the heart should end.
Charles B. Simone II, MD, is at the University of Maryland Medical Center, Baltimore. He reported having no relevant financial disclosures. Dr. Simone made these remarks in an editorial accompanying Dr. Wang’s report (J Clin Oncol. 2017 January 23 [doi: 10.1200/JCO.2016.71.5581]).
Cardiac events are “relatively common,” affecting 23% of patients, and occur earlier than previously thought following radiotherapy for non–small-cell lung cancer (NSCLC), according to a report in the Journal of Clinical Oncology.
Radiation-associated cardiac toxicity has long been recognized in patients treated for other thoracic cancers, but the conventional wisdom has been that it isn’t a consideration in patients with stage III NSCLC because “there are few long-term survivors to experience toxicity, given the typically long latency of radiotherapy-associated heart injury and the poor prognosis” of this cancer. However, the findings “challenge the perception that minimizing heart dose is not important in the treatment of patients with stage III NSCLC,” said Kyle Wang, MD, of University of North Carolina Hospitals, Chapel Hill, and his associates.
“Our data support minimization of heart radiation exposure whenever possible to doses lower than commonly recommended in patients with stage III NSCLC, to reduce risks of [cardiac] toxicity,” they noted.
Dr. Wang and his associates performed a retrospective post hoc analysis of data pooled from six prospective phase I and II trials that the University of North Carolina was involved in between 1996 and 2009. The studies assessed both dose-escalated radiotherapy and various chemotherapeutic regimens in 112 patients who were followed for a median of 8.8 years (range, 2.3-17.3 years). All the patients received induction chemotherapy, 90% received concurrent chemotherapy, and 25% received consolidation chemotherapy.
A total of 26 patients (23%) had at least one symptomatic cardiac event following radiotherapy: pericardial effusion (7 patients), MI (5 patients), unstable angina (3 patients), pericarditis (2 patients), significant arrhythmia (12 patients), and heart failure (1 patient). After the data were adjusted to account for competing risks of death, the 2-year rate of symptomatic cardiac toxicity was 10% and the 4-year rate was 18%. The first adverse cardiac event occurred at a median of 26 months (range, 1-84 months).
The risk of cardiac toxicities rose with increasing radiation exposure: At 2 years, the rate of cardiac events was 4% for those exposed to less than 10 Gy, 7% for those exposed to 10-20 Gy, and 21% for those exposed to greater than 20 Gy. At 4 years, those rates were 4%, 13%, and 41%, respectively. Patients whose hearts were exposed to greater than 20 Gy had a significantly higher rate of cardiac events than did those exposed to less than 10 Gy (HR, 5.47) or to 10-20 Gy (HR, 2.76).
Even though the prognosis may be poor in patients with stage III NSCLC, “they generally receive higher heart doses and may also have more comorbidities and smoking history, thus increasing risk and perhaps shortening the latency between radiotherapy and resultant heart disease,” Dr. Wang and his associates said (J Clin Oncol. 2017 Jan 23 [doi: 10.1200/JCO.2016.70.0229]).
“In our opinion, tumor coverage should rarely be compromised to meet a heart dose constraint. However, it would be reasonable to try to limit heart mean dose to less than 20 Gy (lower if possible) on the basis of the high event rate we observed in patients exceeding this dose (21% at 2 years and 41% at 4 years). Sophisticated radiation treatment planning techniques (e.g., [intensity-modulated radiation therapy]) and charged-particle therapy with protons or carbon ions may provide increased flexibility to generate more conformal treatment plans and reduce heart dose, which could potentially improve the clinical outcomes in patients with stage III NSCLC,” they added.
Cardiac events are “relatively common,” affecting 23% of patients, and occur earlier than previously thought following radiotherapy for non–small-cell lung cancer (NSCLC), according to a report in the Journal of Clinical Oncology.
Radiation-associated cardiac toxicity has long been recognized in patients treated for other thoracic cancers, but the conventional wisdom has been that it isn’t a consideration in patients with stage III NSCLC because “there are few long-term survivors to experience toxicity, given the typically long latency of radiotherapy-associated heart injury and the poor prognosis” of this cancer. However, the findings “challenge the perception that minimizing heart dose is not important in the treatment of patients with stage III NSCLC,” said Kyle Wang, MD, of University of North Carolina Hospitals, Chapel Hill, and his associates.
“Our data support minimization of heart radiation exposure whenever possible to doses lower than commonly recommended in patients with stage III NSCLC, to reduce risks of [cardiac] toxicity,” they noted.
Dr. Wang and his associates performed a retrospective post hoc analysis of data pooled from six prospective phase I and II trials that the University of North Carolina was involved in between 1996 and 2009. The studies assessed both dose-escalated radiotherapy and various chemotherapeutic regimens in 112 patients who were followed for a median of 8.8 years (range, 2.3-17.3 years). All the patients received induction chemotherapy, 90% received concurrent chemotherapy, and 25% received consolidation chemotherapy.
A total of 26 patients (23%) had at least one symptomatic cardiac event following radiotherapy: pericardial effusion (7 patients), MI (5 patients), unstable angina (3 patients), pericarditis (2 patients), significant arrhythmia (12 patients), and heart failure (1 patient). After the data were adjusted to account for competing risks of death, the 2-year rate of symptomatic cardiac toxicity was 10% and the 4-year rate was 18%. The first adverse cardiac event occurred at a median of 26 months (range, 1-84 months).
The risk of cardiac toxicities rose with increasing radiation exposure: At 2 years, the rate of cardiac events was 4% for those exposed to less than 10 Gy, 7% for those exposed to 10-20 Gy, and 21% for those exposed to greater than 20 Gy. At 4 years, those rates were 4%, 13%, and 41%, respectively. Patients whose hearts were exposed to greater than 20 Gy had a significantly higher rate of cardiac events than did those exposed to less than 10 Gy (HR, 5.47) or to 10-20 Gy (HR, 2.76).
Even though the prognosis may be poor in patients with stage III NSCLC, “they generally receive higher heart doses and may also have more comorbidities and smoking history, thus increasing risk and perhaps shortening the latency between radiotherapy and resultant heart disease,” Dr. Wang and his associates said (J Clin Oncol. 2017 Jan 23 [doi: 10.1200/JCO.2016.70.0229]).
“In our opinion, tumor coverage should rarely be compromised to meet a heart dose constraint. However, it would be reasonable to try to limit heart mean dose to less than 20 Gy (lower if possible) on the basis of the high event rate we observed in patients exceeding this dose (21% at 2 years and 41% at 4 years). Sophisticated radiation treatment planning techniques (e.g., [intensity-modulated radiation therapy]) and charged-particle therapy with protons or carbon ions may provide increased flexibility to generate more conformal treatment plans and reduce heart dose, which could potentially improve the clinical outcomes in patients with stage III NSCLC,” they added.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Cardiac events are “relatively common” and occur earlier than previously thought following radiotherapy for NSCLC.
Major finding: Following radiotherapy, 26 of 112 patients (23%) had at least one symptomatic cardiac event: pericardial effusion (7 patients), MI (5 patients), unstable angina (3 patients), pericarditis (2 patients), significant arrhythmia (12 patients), and heart failure (1 patient).
Data source: A retrospective post hoc analysis of data from six phase I and II trials involving 112 patients who received radiotherapy for stage-III NSCLC during 1996-2009.
Disclosures: This study was supported in part by the National Institutes of Health. Dr. Wang reported having no relevant financial disclosures; his associates disclosed ties to La Jolla Pharmaceutical, Vision RT, Medtronic, Novartis, Elekta, Morphomics, Accuray, and Varian Medical Systems.
Judge blocks Aetna-Humana merger
A federal judge has blocked a megamerger between health insurance giants Aetna and Humana, ruling that the consolidation would violate antitrust laws and reduce competition.
In a Jan. 23 decision, Judge John D. Bates of the U.S. District Court for the District of Columbia denied Aetna’s $37 billion plan to purchase Humana, following a month-long trial that began in early December. The court was unpersuaded that the efficiencies generated by the merger would be “sufficient to mitigate the anticompetitive effects for consumers in the challenged markets,” Judge Bates said in his opinion.
The U.S. Department of Justice, which challenged the merger, called the ruling a victory for patients, particularly seniors and working families.
“Competition spurs health insurers to offer higher quality and more affordable health insurance to seniors who choose Medicare Advantage plans and to low-income families and individuals who purchase insurance from public exchanges,” Brent Snyder, deputy assistant attorney general, said in a statement. “Aetna attempted to buy a formidable rival, Humana, instead of competing independently to win customers. Millions of consumers have benefited from competition between Aetna and Humana, and will continue to benefit because of today’s decision to block this merger.”
The Department of Justice, eight states, and the District of Columbia sued Aetna and Humana after an investigation into their proposed July 2015 merger. The government argued that the companies compete head-to-head in the Medicare Advantage and public exchange markets, and that such competition would be lost following the merger to the significant detriment of patients. Aetna and Humana argued their proposed merger would not substantially lessen competition because of the government’s regulatory authority over Medicare Advantage, the threat of entry by new competitors, and the defendants’ proposed divestiture of a portion of their Medicare Advantage business to insurer Molina Healthcare. The insurers also asserted that no current competition between the two companies exists in the 17 complaint counties because Aetna has decided not to compete in those counties in 2017. Judge Bates disagreed.
“The merger would likely substantially lessen competition in the market for individual Medicare Advantage in all 364 complaint counties,” Judge Bates said in his opinion. “This conclusion is based on identification of the proper product market, the overwhelming market concentration figures generated by the merger, and the considerable evidence of valuable head-to-head competition between Aetna and Humana, which the merger would eliminate. The companies’ rebuttal arguments are unpersuasive.”
The American Medical Association praised the ruling.
“Elderly patients were the big winners today as a federal court imposed an injunction on Aetna’s $37 billion acquisition of Humana,” AMA president Andrew W. Gurman, MD, said in a statement. “Aetna’s strategy to eliminate head-to-head competition with rival Humana posed a clear and present threat to the quality, accessibility, and affordability of health care for millions of seniors. The AMA applauds the extraordinarily well-documented, comprehensive, fact-based ruling of U.S. District Judge John D. Bates, which acknowledged that meaningful action was needed to preserve competition and protect high-quality medical care from unprecedented market power that Aetna would acquire from the merger deal.”
Another ruling is expected soon in the $48 billion planned merger between Anthem and Cigna, which is also being challenged by the Justice department. A trial in that case wrapped up in late December in front of U.S. District Court for the District of Columbia Judge Amy Berman.
[email protected]
On Twitter @legal_med
A federal judge has blocked a megamerger between health insurance giants Aetna and Humana, ruling that the consolidation would violate antitrust laws and reduce competition.
In a Jan. 23 decision, Judge John D. Bates of the U.S. District Court for the District of Columbia denied Aetna’s $37 billion plan to purchase Humana, following a month-long trial that began in early December. The court was unpersuaded that the efficiencies generated by the merger would be “sufficient to mitigate the anticompetitive effects for consumers in the challenged markets,” Judge Bates said in his opinion.
The U.S. Department of Justice, which challenged the merger, called the ruling a victory for patients, particularly seniors and working families.
“Competition spurs health insurers to offer higher quality and more affordable health insurance to seniors who choose Medicare Advantage plans and to low-income families and individuals who purchase insurance from public exchanges,” Brent Snyder, deputy assistant attorney general, said in a statement. “Aetna attempted to buy a formidable rival, Humana, instead of competing independently to win customers. Millions of consumers have benefited from competition between Aetna and Humana, and will continue to benefit because of today’s decision to block this merger.”
The Department of Justice, eight states, and the District of Columbia sued Aetna and Humana after an investigation into their proposed July 2015 merger. The government argued that the companies compete head-to-head in the Medicare Advantage and public exchange markets, and that such competition would be lost following the merger to the significant detriment of patients. Aetna and Humana argued their proposed merger would not substantially lessen competition because of the government’s regulatory authority over Medicare Advantage, the threat of entry by new competitors, and the defendants’ proposed divestiture of a portion of their Medicare Advantage business to insurer Molina Healthcare. The insurers also asserted that no current competition between the two companies exists in the 17 complaint counties because Aetna has decided not to compete in those counties in 2017. Judge Bates disagreed.
“The merger would likely substantially lessen competition in the market for individual Medicare Advantage in all 364 complaint counties,” Judge Bates said in his opinion. “This conclusion is based on identification of the proper product market, the overwhelming market concentration figures generated by the merger, and the considerable evidence of valuable head-to-head competition between Aetna and Humana, which the merger would eliminate. The companies’ rebuttal arguments are unpersuasive.”
The American Medical Association praised the ruling.
“Elderly patients were the big winners today as a federal court imposed an injunction on Aetna’s $37 billion acquisition of Humana,” AMA president Andrew W. Gurman, MD, said in a statement. “Aetna’s strategy to eliminate head-to-head competition with rival Humana posed a clear and present threat to the quality, accessibility, and affordability of health care for millions of seniors. The AMA applauds the extraordinarily well-documented, comprehensive, fact-based ruling of U.S. District Judge John D. Bates, which acknowledged that meaningful action was needed to preserve competition and protect high-quality medical care from unprecedented market power that Aetna would acquire from the merger deal.”
Another ruling is expected soon in the $48 billion planned merger between Anthem and Cigna, which is also being challenged by the Justice department. A trial in that case wrapped up in late December in front of U.S. District Court for the District of Columbia Judge Amy Berman.
[email protected]
On Twitter @legal_med
A federal judge has blocked a megamerger between health insurance giants Aetna and Humana, ruling that the consolidation would violate antitrust laws and reduce competition.
In a Jan. 23 decision, Judge John D. Bates of the U.S. District Court for the District of Columbia denied Aetna’s $37 billion plan to purchase Humana, following a month-long trial that began in early December. The court was unpersuaded that the efficiencies generated by the merger would be “sufficient to mitigate the anticompetitive effects for consumers in the challenged markets,” Judge Bates said in his opinion.
The U.S. Department of Justice, which challenged the merger, called the ruling a victory for patients, particularly seniors and working families.
“Competition spurs health insurers to offer higher quality and more affordable health insurance to seniors who choose Medicare Advantage plans and to low-income families and individuals who purchase insurance from public exchanges,” Brent Snyder, deputy assistant attorney general, said in a statement. “Aetna attempted to buy a formidable rival, Humana, instead of competing independently to win customers. Millions of consumers have benefited from competition between Aetna and Humana, and will continue to benefit because of today’s decision to block this merger.”
The Department of Justice, eight states, and the District of Columbia sued Aetna and Humana after an investigation into their proposed July 2015 merger. The government argued that the companies compete head-to-head in the Medicare Advantage and public exchange markets, and that such competition would be lost following the merger to the significant detriment of patients. Aetna and Humana argued their proposed merger would not substantially lessen competition because of the government’s regulatory authority over Medicare Advantage, the threat of entry by new competitors, and the defendants’ proposed divestiture of a portion of their Medicare Advantage business to insurer Molina Healthcare. The insurers also asserted that no current competition between the two companies exists in the 17 complaint counties because Aetna has decided not to compete in those counties in 2017. Judge Bates disagreed.
“The merger would likely substantially lessen competition in the market for individual Medicare Advantage in all 364 complaint counties,” Judge Bates said in his opinion. “This conclusion is based on identification of the proper product market, the overwhelming market concentration figures generated by the merger, and the considerable evidence of valuable head-to-head competition between Aetna and Humana, which the merger would eliminate. The companies’ rebuttal arguments are unpersuasive.”
The American Medical Association praised the ruling.
“Elderly patients were the big winners today as a federal court imposed an injunction on Aetna’s $37 billion acquisition of Humana,” AMA president Andrew W. Gurman, MD, said in a statement. “Aetna’s strategy to eliminate head-to-head competition with rival Humana posed a clear and present threat to the quality, accessibility, and affordability of health care for millions of seniors. The AMA applauds the extraordinarily well-documented, comprehensive, fact-based ruling of U.S. District Judge John D. Bates, which acknowledged that meaningful action was needed to preserve competition and protect high-quality medical care from unprecedented market power that Aetna would acquire from the merger deal.”
Another ruling is expected soon in the $48 billion planned merger between Anthem and Cigna, which is also being challenged by the Justice department. A trial in that case wrapped up in late December in front of U.S. District Court for the District of Columbia Judge Amy Berman.
[email protected]
On Twitter @legal_med
Early, in-hospital shunt failure common among infants
HOUSTON – Among neonates and infants who underwent shunt construction as a source of pulmonary blood flow, early, in-hospital shunt failure occurred in 7.3% of cases, results from a large retrospective study showed.
“Approximately one in seven patients who experiences cardiac surgery in the first year of life undergoes construction of a systemic to pulmonary artery shunt of some type,” one of the study investigators, Marshall L. Jacobs, MD, said in an interview. The study was presented at the annual meeting of the Society of Thoracic Surgeons.
“Early failure of such shunts is an incompletely understood phenomenon which accounts for important morbidity and mortality among infants and neonates. Much of what is known about shunt failure is based on experiences reported from individual institutions. The few multicenter studies to date have been clinical trials that focused primarily on pharmacologic strategies intended to reduce the risk of shunt failure due to thrombosis. Their utility for guiding clinical decision making has been limited. Some have been underpowered; some have had limited risk adjustment of subjects.”
Dr. Do, who presented the findings at the meeting and is currently a Congenital Heart Surgery Fellow at the Children’s Hospital of Philadelphia, and a team of 11 other investigators utilized the STS Congenital Heart Surgery Database to identify 9,172 neonates and infants who underwent shunt construction as a source of pulmonary blood flow at 118 institutions from 2010 to 2015. Criteria for shunt failure included a documented diagnosis of in-hospital shunt failure, shunt revision, or catheter-based shunt intervention. The investigators used multivariable logistic regression to evaluate risk factors for in-hospital shunt failure.
Of the 9,172 at-risk neonates and infants, 674 (7.3%) experienced early, in-hospital shunt failure. “The observed rate of early shunt failure varied across the many specific types of shunts, and was lower with systemic ventricle to pulmonary artery shunts (as in the Sano modification of the Norwood procedure) than with the systemic artery to pulmonary artery shunts,” said Dr. Jacobs, who is a cardiothoracic surgeon at Johns Hopkins University, Baltimore.
In multivariable analysis, risk factors for in-hospital shunt failure included lower weight at operation for both neonates and infants, preoperative hypercoagulable state, and the collective presence of any other STS Congenital Heart Surgery Database preoperative risk factors. Neither cardiopulmonary bypass nor single ventricle diagnosis were risk factors for shunt failure. The investigators also observed that patients with in-hospital shunt failure had significantly higher rates of operative mortality (31.9% vs. 11.1%) and major morbidity (84.4% vs. 29.4%), and longer postoperative length of stay among survivors (a median of 45 vs. 22 days).
“Understanding the characteristics of the patient groups found to be at highest risk for early shunt failure is helpful in identifying individual patients that may warrant expectant surveillance, enhanced pharmacologic management, or other strategies to reduce the risk of shunt failure,” Dr. Jacobs concluded.
“But perhaps more importantly it provides key information that may be helpful in the design and development of future clinical trials and/or collaborative quality improvement initiatives designed to reduce the cost in lives and resources that is associated with early shunt dysfunction.”
He acknowledged certain limitations of the study, including its retrospective observational design and the voluntary nature of the STS Congenital Heart Surgery Database. “In addition, some potentially important variables, such as detailed data concerning preoperative test results of coagulation assays are not collected in the STS Congenital Heart Surgery Database,” he said.
The research was supported by the STS Access & Publications Research program. The investigators reported having no financial disclosures.
HOUSTON – Among neonates and infants who underwent shunt construction as a source of pulmonary blood flow, early, in-hospital shunt failure occurred in 7.3% of cases, results from a large retrospective study showed.
“Approximately one in seven patients who experiences cardiac surgery in the first year of life undergoes construction of a systemic to pulmonary artery shunt of some type,” one of the study investigators, Marshall L. Jacobs, MD, said in an interview. The study was presented at the annual meeting of the Society of Thoracic Surgeons.
“Early failure of such shunts is an incompletely understood phenomenon which accounts for important morbidity and mortality among infants and neonates. Much of what is known about shunt failure is based on experiences reported from individual institutions. The few multicenter studies to date have been clinical trials that focused primarily on pharmacologic strategies intended to reduce the risk of shunt failure due to thrombosis. Their utility for guiding clinical decision making has been limited. Some have been underpowered; some have had limited risk adjustment of subjects.”
Dr. Do, who presented the findings at the meeting and is currently a Congenital Heart Surgery Fellow at the Children’s Hospital of Philadelphia, and a team of 11 other investigators utilized the STS Congenital Heart Surgery Database to identify 9,172 neonates and infants who underwent shunt construction as a source of pulmonary blood flow at 118 institutions from 2010 to 2015. Criteria for shunt failure included a documented diagnosis of in-hospital shunt failure, shunt revision, or catheter-based shunt intervention. The investigators used multivariable logistic regression to evaluate risk factors for in-hospital shunt failure.
Of the 9,172 at-risk neonates and infants, 674 (7.3%) experienced early, in-hospital shunt failure. “The observed rate of early shunt failure varied across the many specific types of shunts, and was lower with systemic ventricle to pulmonary artery shunts (as in the Sano modification of the Norwood procedure) than with the systemic artery to pulmonary artery shunts,” said Dr. Jacobs, who is a cardiothoracic surgeon at Johns Hopkins University, Baltimore.
In multivariable analysis, risk factors for in-hospital shunt failure included lower weight at operation for both neonates and infants, preoperative hypercoagulable state, and the collective presence of any other STS Congenital Heart Surgery Database preoperative risk factors. Neither cardiopulmonary bypass nor single ventricle diagnosis were risk factors for shunt failure. The investigators also observed that patients with in-hospital shunt failure had significantly higher rates of operative mortality (31.9% vs. 11.1%) and major morbidity (84.4% vs. 29.4%), and longer postoperative length of stay among survivors (a median of 45 vs. 22 days).
“Understanding the characteristics of the patient groups found to be at highest risk for early shunt failure is helpful in identifying individual patients that may warrant expectant surveillance, enhanced pharmacologic management, or other strategies to reduce the risk of shunt failure,” Dr. Jacobs concluded.
“But perhaps more importantly it provides key information that may be helpful in the design and development of future clinical trials and/or collaborative quality improvement initiatives designed to reduce the cost in lives and resources that is associated with early shunt dysfunction.”
He acknowledged certain limitations of the study, including its retrospective observational design and the voluntary nature of the STS Congenital Heart Surgery Database. “In addition, some potentially important variables, such as detailed data concerning preoperative test results of coagulation assays are not collected in the STS Congenital Heart Surgery Database,” he said.
The research was supported by the STS Access & Publications Research program. The investigators reported having no financial disclosures.
HOUSTON – Among neonates and infants who underwent shunt construction as a source of pulmonary blood flow, early, in-hospital shunt failure occurred in 7.3% of cases, results from a large retrospective study showed.
“Approximately one in seven patients who experiences cardiac surgery in the first year of life undergoes construction of a systemic to pulmonary artery shunt of some type,” one of the study investigators, Marshall L. Jacobs, MD, said in an interview. The study was presented at the annual meeting of the Society of Thoracic Surgeons.
“Early failure of such shunts is an incompletely understood phenomenon which accounts for important morbidity and mortality among infants and neonates. Much of what is known about shunt failure is based on experiences reported from individual institutions. The few multicenter studies to date have been clinical trials that focused primarily on pharmacologic strategies intended to reduce the risk of shunt failure due to thrombosis. Their utility for guiding clinical decision making has been limited. Some have been underpowered; some have had limited risk adjustment of subjects.”
Dr. Do, who presented the findings at the meeting and is currently a Congenital Heart Surgery Fellow at the Children’s Hospital of Philadelphia, and a team of 11 other investigators utilized the STS Congenital Heart Surgery Database to identify 9,172 neonates and infants who underwent shunt construction as a source of pulmonary blood flow at 118 institutions from 2010 to 2015. Criteria for shunt failure included a documented diagnosis of in-hospital shunt failure, shunt revision, or catheter-based shunt intervention. The investigators used multivariable logistic regression to evaluate risk factors for in-hospital shunt failure.
Of the 9,172 at-risk neonates and infants, 674 (7.3%) experienced early, in-hospital shunt failure. “The observed rate of early shunt failure varied across the many specific types of shunts, and was lower with systemic ventricle to pulmonary artery shunts (as in the Sano modification of the Norwood procedure) than with the systemic artery to pulmonary artery shunts,” said Dr. Jacobs, who is a cardiothoracic surgeon at Johns Hopkins University, Baltimore.
In multivariable analysis, risk factors for in-hospital shunt failure included lower weight at operation for both neonates and infants, preoperative hypercoagulable state, and the collective presence of any other STS Congenital Heart Surgery Database preoperative risk factors. Neither cardiopulmonary bypass nor single ventricle diagnosis were risk factors for shunt failure. The investigators also observed that patients with in-hospital shunt failure had significantly higher rates of operative mortality (31.9% vs. 11.1%) and major morbidity (84.4% vs. 29.4%), and longer postoperative length of stay among survivors (a median of 45 vs. 22 days).
“Understanding the characteristics of the patient groups found to be at highest risk for early shunt failure is helpful in identifying individual patients that may warrant expectant surveillance, enhanced pharmacologic management, or other strategies to reduce the risk of shunt failure,” Dr. Jacobs concluded.
“But perhaps more importantly it provides key information that may be helpful in the design and development of future clinical trials and/or collaborative quality improvement initiatives designed to reduce the cost in lives and resources that is associated with early shunt dysfunction.”
He acknowledged certain limitations of the study, including its retrospective observational design and the voluntary nature of the STS Congenital Heart Surgery Database. “In addition, some potentially important variables, such as detailed data concerning preoperative test results of coagulation assays are not collected in the STS Congenital Heart Surgery Database,” he said.
The research was supported by the STS Access & Publications Research program. The investigators reported having no financial disclosures.
AT THE STS ANNUAL MEETING
Key clinical point:
Major finding: Among neonates and infants who underwent shunt operations, 7.3% experienced early, in-hospital shunt failure.
Data source: A retrospective analysis of 9,172 neonates and infants who underwent shunt construction as a source of pulmonary blood flow at 118 institutions from 2010 to 2015.
Disclosures: The research was supported by the STS Access & Publications Research program. The investigators reported having no financial disclosures.
Multivessel PCI in STEMI gains traction
SNOWMASS, COLO. – The tide appears to have turned regarding the merits of percutaneous coronary intervention in non-infarct-related arteries in conjunction with primary PCI for ST-elevation MI in patients with multivessel disease, Douglas E. Drachman, MD, said at the Annual Cardiovascular Conference at Snowmass.
Previously, multivessel PCI in STEMI patients who are hemodynamically stable was believed harmful and was given a Class IIIb recommendation – meaning don’t do it – in the 2013 American College of Cardiology/American Heart Association STEMI guidelines. Just 2 years later, however, new evidence in the form of three randomized trials prompted a focused update of the joint guidelines in which the practice was upgraded to Class IIb status, meaning it could be considered and may be beneficial.
Roughly 50% of STEMI patients have significant lesions in non-infarct-related arteries (non-IRA). The question of how best to treat such patients is an important one because multivessel coronary disease in STEMI is associated with increased risks of both reinfarction and mortality, noted Dr. Drachman, an interventional cardiologist at Massachusetts General Hospital in Boston.
He offered several reasons why the findings of the three influential randomized trials differed from earlier negative retrospective observational studies: “I would argue there’s been significant improvement in our technique in doing PCI. We’re primarily doing transradial interventions now for our patients, so the risk associated with multiple accesses is reduced. Our ability to use more potent antithrombotic strategies is enhanced by our concern about bleeding risk. And the stent platforms that we use in our interventional strategies have improved to the point that we are tackling ever more challenging lesions with greater aplomb and less concern that we may cause harm. I think all these factors have enhanced the ability of the interventionalist to select and treat non-IRAs in a staged fashion and be less parsimonious at the point of care.”
The remaining questions are which non-IRA lesions should be treated, in whom, when relative to primary PCI, and what are the cost implications? These issues are being tackled in at least eight active randomized controlled trials. Depending upon the answers to come, multivessel PCI in STEMI patients could receive a further upgrade in the guidelines.
Since release of the 2015 focused guideline update, several large studies have provided further backing for multivessel PCI in STEMI patients with significant multivessel disease, although these weren’t randomized prospective studies and hence must be considered hypothesis-generating.
One of these major pieces of evidence was a meta-analysis of observational studies led by Eric R. Bates, MD, professor of internal medicine at the University of Michigan in Ann Arbor. He and his coinvestigators analyzed studies comparing culprit vessel-only primary PCI for STEMI patients with multivessel disease versus staged PCI in which primary PCI was done first, followed by PCI of a non-infarct-related vessel later during the same hospitalization or soon after. Staged PCI was the clear winner, with a 2.2-fold greater likelihood of freedom from mortality (J Am Coll Cardiol. 2016 Sep 6;68(10):1066-81).
When the investigators compared studies of staged PCI versus multivessel PCI in the same session as primary PCI, staged PCI was again the clear winner, with a 4-fold greater freedom from mortality.
Among the possible risks of performing PCI of a non-IRA in the same session as primary PCI are increased risks of thrombosis, contrast-induced nephropathy, stent undersizing due to vasospasm, and unintended jeopardy of distant viable myocardium due to microembolization or side branch occlusion, Dr. Drachman said.
“Maybe in certain circumstances it’s best to let the dust settle after the urgent vessel intervention. Wait a couple of days and then make your plan,” the cardiologist advised.
Another informative recent piece of evidence was provided by a Canadian retrospective observational study which compared revascularization strategies in 6,503 consecutive STEMI patients with multivessel disease. Staged multivessel PCI during the index hospitalization was performed in 658 patients, multivessel PCI during the primary PCI session in 1,325, and PCI limited to the infarct-related artery in 4,520. The study endpoints were 2-year all-cause mortality and repeat revascularization.
Staged multivessel PCI had the lowest mortality and repeat revascularization rates. The 2-year mortality rate associated with this strategy was 45% less than with multivessel intervention at the time of primary PCI and 35% lower than for culprit vessel-only PCI, which unsurprisingly had the highest repeat revascularization rate (JACC Cardiovasc Interv. 2017 Jan 9;10(1):11-23).
The first of the three randomized trials that led to a change in the guidelines was the UK PRAMI study (Preventive Angioplasty in Acute Myocardial Infarction). It showed at a mean 23-months followup that STEMI patients with multivessel disease had a 65% reduction in the relative risk of a composite endoint of cardiovascular death, MI, or refractory angina if they received non-IRA PCI at the same time as primary PCI compared with PCI limited to the IRA (N Engl J Med. 2013 Sep 19;369(12):1115-23).
Next came another UK trial: CvLPRIT (Complete vs. Culprit-Lesion Only Primary PCI) demonstrated a 65% reduction in the composite 12-month outcome of all-cause mortality, MI, heart failure, or ischemia-driven PCI with staged PCI during the index hospitalization compared with culprit vessel-only PCI (J Am Coll Cardiol. 2015 Mar 17;65(10):963-72).
Finally, DANAMI-3-PRIMULTI (the Third Danish Study of Optimal Acute Treatment of Patients with STEMI: Primary PCI in Multivessel Disease) showed a dramatic reduction in the risk of ischemia-driven PCI during a median 27 months of followup in patients who underwent staged multivessel PCI guided by the findings of fractional flow reserve measurement compared with primary PCI limited to the IRA (Lancet. 2015 Aug 15;386(9994):665-71). However, fractional flow reserve-guided multivessel PCI didn’t decrease the risk of death or nonfatal recurrent MI, leaving its role unsettled pending the results of ongoing clinical trials.
Dr. Drachman said it’s clear certain STEMI patients should not undergo non-IRA PCI. These include anyone in whom the procedure would be lengthy due to vessel tortuosity or chronic total occlusion, as well as patients with stable saphenous vein graft disease or heavily calcified lesions requiring atherectomy, since multivessel PCI in those settings would pose a high risk for additional left ventricular dysfunction.
“Be thoughtful about patients who have renal dysfunction,” he added.
Dr. Drachman reported having no financial conflicts of interest.
SNOWMASS, COLO. – The tide appears to have turned regarding the merits of percutaneous coronary intervention in non-infarct-related arteries in conjunction with primary PCI for ST-elevation MI in patients with multivessel disease, Douglas E. Drachman, MD, said at the Annual Cardiovascular Conference at Snowmass.
Previously, multivessel PCI in STEMI patients who are hemodynamically stable was believed harmful and was given a Class IIIb recommendation – meaning don’t do it – in the 2013 American College of Cardiology/American Heart Association STEMI guidelines. Just 2 years later, however, new evidence in the form of three randomized trials prompted a focused update of the joint guidelines in which the practice was upgraded to Class IIb status, meaning it could be considered and may be beneficial.
Roughly 50% of STEMI patients have significant lesions in non-infarct-related arteries (non-IRA). The question of how best to treat such patients is an important one because multivessel coronary disease in STEMI is associated with increased risks of both reinfarction and mortality, noted Dr. Drachman, an interventional cardiologist at Massachusetts General Hospital in Boston.
He offered several reasons why the findings of the three influential randomized trials differed from earlier negative retrospective observational studies: “I would argue there’s been significant improvement in our technique in doing PCI. We’re primarily doing transradial interventions now for our patients, so the risk associated with multiple accesses is reduced. Our ability to use more potent antithrombotic strategies is enhanced by our concern about bleeding risk. And the stent platforms that we use in our interventional strategies have improved to the point that we are tackling ever more challenging lesions with greater aplomb and less concern that we may cause harm. I think all these factors have enhanced the ability of the interventionalist to select and treat non-IRAs in a staged fashion and be less parsimonious at the point of care.”
The remaining questions are which non-IRA lesions should be treated, in whom, when relative to primary PCI, and what are the cost implications? These issues are being tackled in at least eight active randomized controlled trials. Depending upon the answers to come, multivessel PCI in STEMI patients could receive a further upgrade in the guidelines.
Since release of the 2015 focused guideline update, several large studies have provided further backing for multivessel PCI in STEMI patients with significant multivessel disease, although these weren’t randomized prospective studies and hence must be considered hypothesis-generating.
One of these major pieces of evidence was a meta-analysis of observational studies led by Eric R. Bates, MD, professor of internal medicine at the University of Michigan in Ann Arbor. He and his coinvestigators analyzed studies comparing culprit vessel-only primary PCI for STEMI patients with multivessel disease versus staged PCI in which primary PCI was done first, followed by PCI of a non-infarct-related vessel later during the same hospitalization or soon after. Staged PCI was the clear winner, with a 2.2-fold greater likelihood of freedom from mortality (J Am Coll Cardiol. 2016 Sep 6;68(10):1066-81).
When the investigators compared studies of staged PCI versus multivessel PCI in the same session as primary PCI, staged PCI was again the clear winner, with a 4-fold greater freedom from mortality.
Among the possible risks of performing PCI of a non-IRA in the same session as primary PCI are increased risks of thrombosis, contrast-induced nephropathy, stent undersizing due to vasospasm, and unintended jeopardy of distant viable myocardium due to microembolization or side branch occlusion, Dr. Drachman said.
“Maybe in certain circumstances it’s best to let the dust settle after the urgent vessel intervention. Wait a couple of days and then make your plan,” the cardiologist advised.
Another informative recent piece of evidence was provided by a Canadian retrospective observational study which compared revascularization strategies in 6,503 consecutive STEMI patients with multivessel disease. Staged multivessel PCI during the index hospitalization was performed in 658 patients, multivessel PCI during the primary PCI session in 1,325, and PCI limited to the infarct-related artery in 4,520. The study endpoints were 2-year all-cause mortality and repeat revascularization.
Staged multivessel PCI had the lowest mortality and repeat revascularization rates. The 2-year mortality rate associated with this strategy was 45% less than with multivessel intervention at the time of primary PCI and 35% lower than for culprit vessel-only PCI, which unsurprisingly had the highest repeat revascularization rate (JACC Cardiovasc Interv. 2017 Jan 9;10(1):11-23).
The first of the three randomized trials that led to a change in the guidelines was the UK PRAMI study (Preventive Angioplasty in Acute Myocardial Infarction). It showed at a mean 23-months followup that STEMI patients with multivessel disease had a 65% reduction in the relative risk of a composite endoint of cardiovascular death, MI, or refractory angina if they received non-IRA PCI at the same time as primary PCI compared with PCI limited to the IRA (N Engl J Med. 2013 Sep 19;369(12):1115-23).
Next came another UK trial: CvLPRIT (Complete vs. Culprit-Lesion Only Primary PCI) demonstrated a 65% reduction in the composite 12-month outcome of all-cause mortality, MI, heart failure, or ischemia-driven PCI with staged PCI during the index hospitalization compared with culprit vessel-only PCI (J Am Coll Cardiol. 2015 Mar 17;65(10):963-72).
Finally, DANAMI-3-PRIMULTI (the Third Danish Study of Optimal Acute Treatment of Patients with STEMI: Primary PCI in Multivessel Disease) showed a dramatic reduction in the risk of ischemia-driven PCI during a median 27 months of followup in patients who underwent staged multivessel PCI guided by the findings of fractional flow reserve measurement compared with primary PCI limited to the IRA (Lancet. 2015 Aug 15;386(9994):665-71). However, fractional flow reserve-guided multivessel PCI didn’t decrease the risk of death or nonfatal recurrent MI, leaving its role unsettled pending the results of ongoing clinical trials.
Dr. Drachman said it’s clear certain STEMI patients should not undergo non-IRA PCI. These include anyone in whom the procedure would be lengthy due to vessel tortuosity or chronic total occlusion, as well as patients with stable saphenous vein graft disease or heavily calcified lesions requiring atherectomy, since multivessel PCI in those settings would pose a high risk for additional left ventricular dysfunction.
“Be thoughtful about patients who have renal dysfunction,” he added.
Dr. Drachman reported having no financial conflicts of interest.
SNOWMASS, COLO. – The tide appears to have turned regarding the merits of percutaneous coronary intervention in non-infarct-related arteries in conjunction with primary PCI for ST-elevation MI in patients with multivessel disease, Douglas E. Drachman, MD, said at the Annual Cardiovascular Conference at Snowmass.
Previously, multivessel PCI in STEMI patients who are hemodynamically stable was believed harmful and was given a Class IIIb recommendation – meaning don’t do it – in the 2013 American College of Cardiology/American Heart Association STEMI guidelines. Just 2 years later, however, new evidence in the form of three randomized trials prompted a focused update of the joint guidelines in which the practice was upgraded to Class IIb status, meaning it could be considered and may be beneficial.
Roughly 50% of STEMI patients have significant lesions in non-infarct-related arteries (non-IRA). The question of how best to treat such patients is an important one because multivessel coronary disease in STEMI is associated with increased risks of both reinfarction and mortality, noted Dr. Drachman, an interventional cardiologist at Massachusetts General Hospital in Boston.
He offered several reasons why the findings of the three influential randomized trials differed from earlier negative retrospective observational studies: “I would argue there’s been significant improvement in our technique in doing PCI. We’re primarily doing transradial interventions now for our patients, so the risk associated with multiple accesses is reduced. Our ability to use more potent antithrombotic strategies is enhanced by our concern about bleeding risk. And the stent platforms that we use in our interventional strategies have improved to the point that we are tackling ever more challenging lesions with greater aplomb and less concern that we may cause harm. I think all these factors have enhanced the ability of the interventionalist to select and treat non-IRAs in a staged fashion and be less parsimonious at the point of care.”
The remaining questions are which non-IRA lesions should be treated, in whom, when relative to primary PCI, and what are the cost implications? These issues are being tackled in at least eight active randomized controlled trials. Depending upon the answers to come, multivessel PCI in STEMI patients could receive a further upgrade in the guidelines.
Since release of the 2015 focused guideline update, several large studies have provided further backing for multivessel PCI in STEMI patients with significant multivessel disease, although these weren’t randomized prospective studies and hence must be considered hypothesis-generating.
One of these major pieces of evidence was a meta-analysis of observational studies led by Eric R. Bates, MD, professor of internal medicine at the University of Michigan in Ann Arbor. He and his coinvestigators analyzed studies comparing culprit vessel-only primary PCI for STEMI patients with multivessel disease versus staged PCI in which primary PCI was done first, followed by PCI of a non-infarct-related vessel later during the same hospitalization or soon after. Staged PCI was the clear winner, with a 2.2-fold greater likelihood of freedom from mortality (J Am Coll Cardiol. 2016 Sep 6;68(10):1066-81).
When the investigators compared studies of staged PCI versus multivessel PCI in the same session as primary PCI, staged PCI was again the clear winner, with a 4-fold greater freedom from mortality.
Among the possible risks of performing PCI of a non-IRA in the same session as primary PCI are increased risks of thrombosis, contrast-induced nephropathy, stent undersizing due to vasospasm, and unintended jeopardy of distant viable myocardium due to microembolization or side branch occlusion, Dr. Drachman said.
“Maybe in certain circumstances it’s best to let the dust settle after the urgent vessel intervention. Wait a couple of days and then make your plan,” the cardiologist advised.
Another informative recent piece of evidence was provided by a Canadian retrospective observational study which compared revascularization strategies in 6,503 consecutive STEMI patients with multivessel disease. Staged multivessel PCI during the index hospitalization was performed in 658 patients, multivessel PCI during the primary PCI session in 1,325, and PCI limited to the infarct-related artery in 4,520. The study endpoints were 2-year all-cause mortality and repeat revascularization.
Staged multivessel PCI had the lowest mortality and repeat revascularization rates. The 2-year mortality rate associated with this strategy was 45% less than with multivessel intervention at the time of primary PCI and 35% lower than for culprit vessel-only PCI, which unsurprisingly had the highest repeat revascularization rate (JACC Cardiovasc Interv. 2017 Jan 9;10(1):11-23).
The first of the three randomized trials that led to a change in the guidelines was the UK PRAMI study (Preventive Angioplasty in Acute Myocardial Infarction). It showed at a mean 23-months followup that STEMI patients with multivessel disease had a 65% reduction in the relative risk of a composite endoint of cardiovascular death, MI, or refractory angina if they received non-IRA PCI at the same time as primary PCI compared with PCI limited to the IRA (N Engl J Med. 2013 Sep 19;369(12):1115-23).
Next came another UK trial: CvLPRIT (Complete vs. Culprit-Lesion Only Primary PCI) demonstrated a 65% reduction in the composite 12-month outcome of all-cause mortality, MI, heart failure, or ischemia-driven PCI with staged PCI during the index hospitalization compared with culprit vessel-only PCI (J Am Coll Cardiol. 2015 Mar 17;65(10):963-72).
Finally, DANAMI-3-PRIMULTI (the Third Danish Study of Optimal Acute Treatment of Patients with STEMI: Primary PCI in Multivessel Disease) showed a dramatic reduction in the risk of ischemia-driven PCI during a median 27 months of followup in patients who underwent staged multivessel PCI guided by the findings of fractional flow reserve measurement compared with primary PCI limited to the IRA (Lancet. 2015 Aug 15;386(9994):665-71). However, fractional flow reserve-guided multivessel PCI didn’t decrease the risk of death or nonfatal recurrent MI, leaving its role unsettled pending the results of ongoing clinical trials.
Dr. Drachman said it’s clear certain STEMI patients should not undergo non-IRA PCI. These include anyone in whom the procedure would be lengthy due to vessel tortuosity or chronic total occlusion, as well as patients with stable saphenous vein graft disease or heavily calcified lesions requiring atherectomy, since multivessel PCI in those settings would pose a high risk for additional left ventricular dysfunction.
“Be thoughtful about patients who have renal dysfunction,” he added.
Dr. Drachman reported having no financial conflicts of interest.
EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS