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Patent foramen ovale and the risk of cryptogenic stroke
The article by Roth and Alli in this issue describes in depth more than 10 years of research that addresses the question, Should we close a patent foramen ovale (PFO) to prevent recurrent cryptogenic stroke?
There is no longer any doubt that PFO can be the pathway for thrombus from the venous circulation to go from the right atrium to the left atrium, bypassing the pulmonary capillary filtration bed, and entering the arterial side to produce a stroke, myocardial infarction, or peripheral embolus. Two questions remain: What should we do to prevent another episode? And is percutaneous closure of a PFO with the current devices preferable to medical therapy?
How much do we know about the risks and benefits of closure of PFO? I maintain that we know a great deal about interatrial shunt and paradoxical embolism as a cause of cryptogenic stroke. Prospective randomized clinical trials now give us data with which we can provide appropriate direction to our patients. Percutaneous closure is no longer an “experimental procedure,” as insurance companies claim. The experiment has been done, and the only issue is how one interprets the data from the randomized clinical trials.
The review by Roth and Alli comprehensively describes the observational studies, as well as the three randomized clinical trials done to determine whether PFO closure is preferable to medical therapy to prevent recurrent stroke in patients who have already had one cryptogenic stroke. If we understand some of the subtleties and differences between the trials, we can reach an appropriate conclusion as to what to recommend to our patients.
A review of 10 reports of transcatheter closure of PFO vs six reports of medical therapy for cryptogenic stroke showed a range of rates of recurrent stroke at 1 year—between 0% and 4.9% for transcatheter closure, and between 3.8% and 12% for medical therapy.1
These numbers are important because they were used to estimate the number of patients that would be necessary to study in a randomized clinical trial to demonstrate a benefit of PFO closure vs medical therapy. Unlike most studies of new devices, the PFO closure trials were done in an environment in which patients could get their PFO closed with other devices that were already approved by the US Food and Drug Administration (FDA) for closure of an atrial septal defect. This ability of patients to obtain PFO closure outside of the trial with an off-label device meant that the patients who agreed to be randomized tended to have lower risk for recurrence than patients studied in the observational populations. From a practical standpoint, this meant that the event rate in the patients who participated in the randomized clinical trials (1.7% per year) was lower than predicted from the observational studies.2,3
Another way of saying this is that the randomized clinical trials were underpowered to answer the question. A common way of dealing with this problem is to combine the results of different studies in a meta-analysis. This makes sense if the studies are assessing the same thing. This is not the case with the PFO closure trials. Although the topic of percutaneous PFO closure vs medical therapy was the same, the devices used were different.
In the CLOSURE trial (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale),3 the device used was the STARFlex, which is no longer produced—and for good reasons. It is not as effective as the Amplatzer or Helex devices in completely closing the right-to-left shunt produced by a PFO. In addition, the CardioSEAL or STARFlex device increases the risk of atrial fibrillation, which was seen in 6% of the treated patients.3 This was the major cause of recurrent stroke in the CLOSURE trial. The CardioSEAL STARFlex device was also more thrombogenic.
In the RESPECT trial (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment),2 which used the Amplatzer PFO closure device, there was no increased incidence of atrial fibrillation in the device group compared with the control group. Therefore, it is not appropriate to combine the results of the CLOSURE trial with the results of the RESPECT trial and PC trial,4 both of which used the Amplatzer device.
Our patients want to know what the potential risks and benefits will be if they get their PFO closed with a specific device. They don’t want to know the average risk between two different devices.
However, if you do a meta-analysis of the RESPECT and PC trials, which used the same Amplatzer PFO occluder device, and combine the number of patients studied to increase the statistical power, then the benefit of PFO closure is significant even with an intention-to-treat analysis. By combining the two studies that assessed the same device, you reach a completely different interpretation than if you do a meta-analysis including the CLOSURE trial, which showed no benefit.
The medical community should not uncritically accept meta-analysis methodology. It is a marvelous case example of how scientific methods can be inappropriately used and two diametrically opposed conclusions reached if the meta-analysis combines two different types of devices vs a meta-analysis of just the Amplatzer device.
If we combine the numbers from the RESPECT and PC trials, there were 23 strokes in 691 patients (3.3%) in the medical groups and 10 strokes in 703 patients (1.4%) who underwent PFO closure. By chi square analysis of this intention-to-treat protocol, PFO closure provides a statistically significant reduction in preventing recurrent stroke (95% confidence interval 0.20–0.89, P = .02).
From the patient’s perspective, what is important is this: If I get my PFO closed with an Amplatzer PFO occluder device, what are the risks of the procedure, and what are the potential benefits compared with medical therapy? We can now answer that question definitively. I tell my patients, “The risks of the procedure are remarkably low (about 1%) in experienced hands, and the benefit is that your risk of recurrent stroke will be reduced 73%2 compared with medical therapy.” In the RESPECT Trial, the as-treated cohort consisted of 958 patients with 21 primary end-point events (5 in the closure group and 16 in the medical-therapy group). The rate of the primary end point was 0.39 events per 100 patient-years in the closure group vs 1.45 events per 100 patient-years in the medical-therapy group (hazard ratio 0.27; 95% confidence interval 0.10–0.75; P = .007).
Not all cryptogenic strokes in people who have a PFO are caused by paradoxical embolism. PFO may be an innocent bystander. In addition, not all people who have a paradoxical embolism will have a recurrent stroke. For example, if a young woman presents with a PFO and stroke, is it possible that she can prevent another stroke just by stopping her birth-control pills and not have her PFO closed? What is the risk of recurrent stroke if she were to become pregnant? We do not know the answers to these questions.
Your patients do not want to wait to find out if they are going to have another stroke. The meta-analysis of the randomized clinical trials for paradoxical embolism demonstrates that the closure devices are safe and effective. The FDA should approve the Amplatzer PFO occluder with an indication to prevent recurrent stroke in patients with PFO and an initial cryptogenic event.
- Khairy P, O’Donnell CP, Landzberg MJ. Transcatheter closure versus medical therapy of patent foramen ovale and presumed paradoxical thromboemboli: a systematic review. Ann Intern Med 2003; 139:753–760.
- Carroll JD, Saver JL, Thaler DE, et al; RESPECT Investigators. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med 2013; 368:1092–1100.
- Furlan AJ, Reisman M, Massaro J, et al; CLOSURE Investigators. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med 2012; 366:991–999.
- Meier B, Kalesan B, Mattle HP, et al; PC Trial Investigators. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med 2013; 368:1083–1091.
The article by Roth and Alli in this issue describes in depth more than 10 years of research that addresses the question, Should we close a patent foramen ovale (PFO) to prevent recurrent cryptogenic stroke?
There is no longer any doubt that PFO can be the pathway for thrombus from the venous circulation to go from the right atrium to the left atrium, bypassing the pulmonary capillary filtration bed, and entering the arterial side to produce a stroke, myocardial infarction, or peripheral embolus. Two questions remain: What should we do to prevent another episode? And is percutaneous closure of a PFO with the current devices preferable to medical therapy?
How much do we know about the risks and benefits of closure of PFO? I maintain that we know a great deal about interatrial shunt and paradoxical embolism as a cause of cryptogenic stroke. Prospective randomized clinical trials now give us data with which we can provide appropriate direction to our patients. Percutaneous closure is no longer an “experimental procedure,” as insurance companies claim. The experiment has been done, and the only issue is how one interprets the data from the randomized clinical trials.
The review by Roth and Alli comprehensively describes the observational studies, as well as the three randomized clinical trials done to determine whether PFO closure is preferable to medical therapy to prevent recurrent stroke in patients who have already had one cryptogenic stroke. If we understand some of the subtleties and differences between the trials, we can reach an appropriate conclusion as to what to recommend to our patients.
A review of 10 reports of transcatheter closure of PFO vs six reports of medical therapy for cryptogenic stroke showed a range of rates of recurrent stroke at 1 year—between 0% and 4.9% for transcatheter closure, and between 3.8% and 12% for medical therapy.1
These numbers are important because they were used to estimate the number of patients that would be necessary to study in a randomized clinical trial to demonstrate a benefit of PFO closure vs medical therapy. Unlike most studies of new devices, the PFO closure trials were done in an environment in which patients could get their PFO closed with other devices that were already approved by the US Food and Drug Administration (FDA) for closure of an atrial septal defect. This ability of patients to obtain PFO closure outside of the trial with an off-label device meant that the patients who agreed to be randomized tended to have lower risk for recurrence than patients studied in the observational populations. From a practical standpoint, this meant that the event rate in the patients who participated in the randomized clinical trials (1.7% per year) was lower than predicted from the observational studies.2,3
Another way of saying this is that the randomized clinical trials were underpowered to answer the question. A common way of dealing with this problem is to combine the results of different studies in a meta-analysis. This makes sense if the studies are assessing the same thing. This is not the case with the PFO closure trials. Although the topic of percutaneous PFO closure vs medical therapy was the same, the devices used were different.
In the CLOSURE trial (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale),3 the device used was the STARFlex, which is no longer produced—and for good reasons. It is not as effective as the Amplatzer or Helex devices in completely closing the right-to-left shunt produced by a PFO. In addition, the CardioSEAL or STARFlex device increases the risk of atrial fibrillation, which was seen in 6% of the treated patients.3 This was the major cause of recurrent stroke in the CLOSURE trial. The CardioSEAL STARFlex device was also more thrombogenic.
In the RESPECT trial (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment),2 which used the Amplatzer PFO closure device, there was no increased incidence of atrial fibrillation in the device group compared with the control group. Therefore, it is not appropriate to combine the results of the CLOSURE trial with the results of the RESPECT trial and PC trial,4 both of which used the Amplatzer device.
Our patients want to know what the potential risks and benefits will be if they get their PFO closed with a specific device. They don’t want to know the average risk between two different devices.
However, if you do a meta-analysis of the RESPECT and PC trials, which used the same Amplatzer PFO occluder device, and combine the number of patients studied to increase the statistical power, then the benefit of PFO closure is significant even with an intention-to-treat analysis. By combining the two studies that assessed the same device, you reach a completely different interpretation than if you do a meta-analysis including the CLOSURE trial, which showed no benefit.
The medical community should not uncritically accept meta-analysis methodology. It is a marvelous case example of how scientific methods can be inappropriately used and two diametrically opposed conclusions reached if the meta-analysis combines two different types of devices vs a meta-analysis of just the Amplatzer device.
If we combine the numbers from the RESPECT and PC trials, there were 23 strokes in 691 patients (3.3%) in the medical groups and 10 strokes in 703 patients (1.4%) who underwent PFO closure. By chi square analysis of this intention-to-treat protocol, PFO closure provides a statistically significant reduction in preventing recurrent stroke (95% confidence interval 0.20–0.89, P = .02).
From the patient’s perspective, what is important is this: If I get my PFO closed with an Amplatzer PFO occluder device, what are the risks of the procedure, and what are the potential benefits compared with medical therapy? We can now answer that question definitively. I tell my patients, “The risks of the procedure are remarkably low (about 1%) in experienced hands, and the benefit is that your risk of recurrent stroke will be reduced 73%2 compared with medical therapy.” In the RESPECT Trial, the as-treated cohort consisted of 958 patients with 21 primary end-point events (5 in the closure group and 16 in the medical-therapy group). The rate of the primary end point was 0.39 events per 100 patient-years in the closure group vs 1.45 events per 100 patient-years in the medical-therapy group (hazard ratio 0.27; 95% confidence interval 0.10–0.75; P = .007).
Not all cryptogenic strokes in people who have a PFO are caused by paradoxical embolism. PFO may be an innocent bystander. In addition, not all people who have a paradoxical embolism will have a recurrent stroke. For example, if a young woman presents with a PFO and stroke, is it possible that she can prevent another stroke just by stopping her birth-control pills and not have her PFO closed? What is the risk of recurrent stroke if she were to become pregnant? We do not know the answers to these questions.
Your patients do not want to wait to find out if they are going to have another stroke. The meta-analysis of the randomized clinical trials for paradoxical embolism demonstrates that the closure devices are safe and effective. The FDA should approve the Amplatzer PFO occluder with an indication to prevent recurrent stroke in patients with PFO and an initial cryptogenic event.
The article by Roth and Alli in this issue describes in depth more than 10 years of research that addresses the question, Should we close a patent foramen ovale (PFO) to prevent recurrent cryptogenic stroke?
There is no longer any doubt that PFO can be the pathway for thrombus from the venous circulation to go from the right atrium to the left atrium, bypassing the pulmonary capillary filtration bed, and entering the arterial side to produce a stroke, myocardial infarction, or peripheral embolus. Two questions remain: What should we do to prevent another episode? And is percutaneous closure of a PFO with the current devices preferable to medical therapy?
How much do we know about the risks and benefits of closure of PFO? I maintain that we know a great deal about interatrial shunt and paradoxical embolism as a cause of cryptogenic stroke. Prospective randomized clinical trials now give us data with which we can provide appropriate direction to our patients. Percutaneous closure is no longer an “experimental procedure,” as insurance companies claim. The experiment has been done, and the only issue is how one interprets the data from the randomized clinical trials.
The review by Roth and Alli comprehensively describes the observational studies, as well as the three randomized clinical trials done to determine whether PFO closure is preferable to medical therapy to prevent recurrent stroke in patients who have already had one cryptogenic stroke. If we understand some of the subtleties and differences between the trials, we can reach an appropriate conclusion as to what to recommend to our patients.
A review of 10 reports of transcatheter closure of PFO vs six reports of medical therapy for cryptogenic stroke showed a range of rates of recurrent stroke at 1 year—between 0% and 4.9% for transcatheter closure, and between 3.8% and 12% for medical therapy.1
These numbers are important because they were used to estimate the number of patients that would be necessary to study in a randomized clinical trial to demonstrate a benefit of PFO closure vs medical therapy. Unlike most studies of new devices, the PFO closure trials were done in an environment in which patients could get their PFO closed with other devices that were already approved by the US Food and Drug Administration (FDA) for closure of an atrial septal defect. This ability of patients to obtain PFO closure outside of the trial with an off-label device meant that the patients who agreed to be randomized tended to have lower risk for recurrence than patients studied in the observational populations. From a practical standpoint, this meant that the event rate in the patients who participated in the randomized clinical trials (1.7% per year) was lower than predicted from the observational studies.2,3
Another way of saying this is that the randomized clinical trials were underpowered to answer the question. A common way of dealing with this problem is to combine the results of different studies in a meta-analysis. This makes sense if the studies are assessing the same thing. This is not the case with the PFO closure trials. Although the topic of percutaneous PFO closure vs medical therapy was the same, the devices used were different.
In the CLOSURE trial (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale),3 the device used was the STARFlex, which is no longer produced—and for good reasons. It is not as effective as the Amplatzer or Helex devices in completely closing the right-to-left shunt produced by a PFO. In addition, the CardioSEAL or STARFlex device increases the risk of atrial fibrillation, which was seen in 6% of the treated patients.3 This was the major cause of recurrent stroke in the CLOSURE trial. The CardioSEAL STARFlex device was also more thrombogenic.
In the RESPECT trial (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment),2 which used the Amplatzer PFO closure device, there was no increased incidence of atrial fibrillation in the device group compared with the control group. Therefore, it is not appropriate to combine the results of the CLOSURE trial with the results of the RESPECT trial and PC trial,4 both of which used the Amplatzer device.
Our patients want to know what the potential risks and benefits will be if they get their PFO closed with a specific device. They don’t want to know the average risk between two different devices.
However, if you do a meta-analysis of the RESPECT and PC trials, which used the same Amplatzer PFO occluder device, and combine the number of patients studied to increase the statistical power, then the benefit of PFO closure is significant even with an intention-to-treat analysis. By combining the two studies that assessed the same device, you reach a completely different interpretation than if you do a meta-analysis including the CLOSURE trial, which showed no benefit.
The medical community should not uncritically accept meta-analysis methodology. It is a marvelous case example of how scientific methods can be inappropriately used and two diametrically opposed conclusions reached if the meta-analysis combines two different types of devices vs a meta-analysis of just the Amplatzer device.
If we combine the numbers from the RESPECT and PC trials, there were 23 strokes in 691 patients (3.3%) in the medical groups and 10 strokes in 703 patients (1.4%) who underwent PFO closure. By chi square analysis of this intention-to-treat protocol, PFO closure provides a statistically significant reduction in preventing recurrent stroke (95% confidence interval 0.20–0.89, P = .02).
From the patient’s perspective, what is important is this: If I get my PFO closed with an Amplatzer PFO occluder device, what are the risks of the procedure, and what are the potential benefits compared with medical therapy? We can now answer that question definitively. I tell my patients, “The risks of the procedure are remarkably low (about 1%) in experienced hands, and the benefit is that your risk of recurrent stroke will be reduced 73%2 compared with medical therapy.” In the RESPECT Trial, the as-treated cohort consisted of 958 patients with 21 primary end-point events (5 in the closure group and 16 in the medical-therapy group). The rate of the primary end point was 0.39 events per 100 patient-years in the closure group vs 1.45 events per 100 patient-years in the medical-therapy group (hazard ratio 0.27; 95% confidence interval 0.10–0.75; P = .007).
Not all cryptogenic strokes in people who have a PFO are caused by paradoxical embolism. PFO may be an innocent bystander. In addition, not all people who have a paradoxical embolism will have a recurrent stroke. For example, if a young woman presents with a PFO and stroke, is it possible that she can prevent another stroke just by stopping her birth-control pills and not have her PFO closed? What is the risk of recurrent stroke if she were to become pregnant? We do not know the answers to these questions.
Your patients do not want to wait to find out if they are going to have another stroke. The meta-analysis of the randomized clinical trials for paradoxical embolism demonstrates that the closure devices are safe and effective. The FDA should approve the Amplatzer PFO occluder with an indication to prevent recurrent stroke in patients with PFO and an initial cryptogenic event.
- Khairy P, O’Donnell CP, Landzberg MJ. Transcatheter closure versus medical therapy of patent foramen ovale and presumed paradoxical thromboemboli: a systematic review. Ann Intern Med 2003; 139:753–760.
- Carroll JD, Saver JL, Thaler DE, et al; RESPECT Investigators. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med 2013; 368:1092–1100.
- Furlan AJ, Reisman M, Massaro J, et al; CLOSURE Investigators. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med 2012; 366:991–999.
- Meier B, Kalesan B, Mattle HP, et al; PC Trial Investigators. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med 2013; 368:1083–1091.
- Khairy P, O’Donnell CP, Landzberg MJ. Transcatheter closure versus medical therapy of patent foramen ovale and presumed paradoxical thromboemboli: a systematic review. Ann Intern Med 2003; 139:753–760.
- Carroll JD, Saver JL, Thaler DE, et al; RESPECT Investigators. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med 2013; 368:1092–1100.
- Furlan AJ, Reisman M, Massaro J, et al; CLOSURE Investigators. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med 2012; 366:991–999.
- Meier B, Kalesan B, Mattle HP, et al; PC Trial Investigators. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med 2013; 368:1083–1091.
Changes to practice may help avoid ‘double trouble’
Large-volume thoracentesis is defined as the drainage of more than 1 L of fluid. Inherent in this procedure is the removal of a large amount of fluid from a cavity with a rigid wall, which leads to changes in pleural pressure and to expansion of the lung. Two specific complications occur, pneumothorax and reexpansion pulmonary edema. The images submitted for the Clinical Picture article by Drs. Apter and Aronowitz in this issue of the Journal highlight these complications.
Retrospective studies have found an association between the amount of fluid drained and the incidence of pneumothorax.1,2 Although technical issues may account for it (eg, needle injury to the lung that leads to postprocedural pneumothorax), the available evidence suggests that it has more to do with the drainage of larger volumes than the lung can expand to fill.3,4 That is, the patient’s lung cannot expand,5 so drainage creates a vacuum, and air enters the pleural space3 through the lung parenchyma, or perhaps from around the drainage catheter.
In a series of patients who underwent therapeutic thoracentesis,3 23 (8.7%) of 265 patients had pneumothorax. Interestingly, some patients had only symptoms, some had only excessively negative pressures (< 25 cm H2O), some had both, and some had neither. Thus, there does not seem to be a reliable sign or symptom of an unexpanding lung, but pleural manometry may help increase its detection.6 This technique, however, is rarely used in clinical practice.
Another consequence of therapeutic thoracentesis is reexpansion pulmonary edema. This rare condition occurs only after large-volume thoracentesis or evacuation of a moderate to large pneumothorax.7 The pathophysiology behind this is controversial.8 As with pneumothorax, a large case series did not find a correlation between volume removed or pleural pressures and reexpansion pulmonary edema.7 Experimental data and analysis of case series8–10 suggest that the duration of lung collapse and the speed of drainage and negative pressure applied contribute to the development of edema. Vacuum bottles are often used to speed drainage and to contain the large amount of fluid drained. These bottles have an initial negative pressure of about −723 mm Hg (personal communication with Baxter Healthcare Product information line), which may lead to rapid changes in lung volume and perhaps to higher negative pleural pressures.
Given the risks discussed above, we believe it is appropriate to avoid vacuum bottles and instead to use the syringe and one-way valve supplied in most thoracentesis kits. Further, pleural manometry to detect changes in pressure that suggest an unexpandable lung may lead to the appropriate early termination of a planned large-volume thoracentesis.3 The complications reported by Drs. Apter and Aronowitz are relatively rare and, at this point, unpredictable; therefore, generating high-quality evidence for prediction or management will be difficult. In the meantime, understanding the physiologic changes in the lung and the pleural space when draining large effusions from the chest may help avoid double trouble.
- Josephson T, Nordenskjold CA, Larsson J, Rosenberg LU, Kaijser M. Amount drained at ultrasound-guided thoracentesis and risk of pneumothorax. Acta Radiol 2009; 50:42–47.
- Gordon CE, Feller-Kopman D, Balk EM, Smetana GW. Pneumothorax following thoracentesis: a systematic review and meta-analysis. Arch Intern Med 2010; 170:332–339.
- Heidecker J, Huggins JT, Sahn SA, Doelken P. Pathophysiology of pneumothorax following ultrasound-guided thoracentesis. Chest 2006; 130:1173–1184.
- Huggins JT, Sahn SA, Heidecker J, Ravenel JG, Doelken P. Characteristics of trapped lung: pleural fluid analysis, manometry, and air-contrast chest CT. Chest 2007; 131:206–213.
- Woodring JH, Baker MD, Stark P. Pneumothorax ex vacuo. Chest 1996; 110:1102–1105.
- Feller-Kopman D. Therapeutic thoracentesis: the role of ultrasound and pleural manometry. Curr Opin Pulmon Med 2007; 13:312–318.
- Feller-Kopman D, Berkowitz D, Boiselle P, Ernst A. Large-volume thoracentesis and the risk of reexpansion pulmonary edema. Ann Thorac Surg 2007; 84:1656–1661.
- Tarver RD, Broderick LS, Conces DJ, Jr. Reexpansion pulmonary edema. J Thorac Imag 1996; 11:198–209.
- Murphy K, Tomlanovich MC. Unilateral pulmonary edema after drainage of a spontaneous pneumothorax: case report and review of the world literature. J Emerg Med 1983; 1:29–36.
- Pavlin J, Cheney FW Unilateral pulmonary edema in rabbits after reexpansion of collapsed lung. J Appl Physiol Respir Environ Exerc Physiol 1979; 46:31–35.
Large-volume thoracentesis is defined as the drainage of more than 1 L of fluid. Inherent in this procedure is the removal of a large amount of fluid from a cavity with a rigid wall, which leads to changes in pleural pressure and to expansion of the lung. Two specific complications occur, pneumothorax and reexpansion pulmonary edema. The images submitted for the Clinical Picture article by Drs. Apter and Aronowitz in this issue of the Journal highlight these complications.
Retrospective studies have found an association between the amount of fluid drained and the incidence of pneumothorax.1,2 Although technical issues may account for it (eg, needle injury to the lung that leads to postprocedural pneumothorax), the available evidence suggests that it has more to do with the drainage of larger volumes than the lung can expand to fill.3,4 That is, the patient’s lung cannot expand,5 so drainage creates a vacuum, and air enters the pleural space3 through the lung parenchyma, or perhaps from around the drainage catheter.
In a series of patients who underwent therapeutic thoracentesis,3 23 (8.7%) of 265 patients had pneumothorax. Interestingly, some patients had only symptoms, some had only excessively negative pressures (< 25 cm H2O), some had both, and some had neither. Thus, there does not seem to be a reliable sign or symptom of an unexpanding lung, but pleural manometry may help increase its detection.6 This technique, however, is rarely used in clinical practice.
Another consequence of therapeutic thoracentesis is reexpansion pulmonary edema. This rare condition occurs only after large-volume thoracentesis or evacuation of a moderate to large pneumothorax.7 The pathophysiology behind this is controversial.8 As with pneumothorax, a large case series did not find a correlation between volume removed or pleural pressures and reexpansion pulmonary edema.7 Experimental data and analysis of case series8–10 suggest that the duration of lung collapse and the speed of drainage and negative pressure applied contribute to the development of edema. Vacuum bottles are often used to speed drainage and to contain the large amount of fluid drained. These bottles have an initial negative pressure of about −723 mm Hg (personal communication with Baxter Healthcare Product information line), which may lead to rapid changes in lung volume and perhaps to higher negative pleural pressures.
Given the risks discussed above, we believe it is appropriate to avoid vacuum bottles and instead to use the syringe and one-way valve supplied in most thoracentesis kits. Further, pleural manometry to detect changes in pressure that suggest an unexpandable lung may lead to the appropriate early termination of a planned large-volume thoracentesis.3 The complications reported by Drs. Apter and Aronowitz are relatively rare and, at this point, unpredictable; therefore, generating high-quality evidence for prediction or management will be difficult. In the meantime, understanding the physiologic changes in the lung and the pleural space when draining large effusions from the chest may help avoid double trouble.
Large-volume thoracentesis is defined as the drainage of more than 1 L of fluid. Inherent in this procedure is the removal of a large amount of fluid from a cavity with a rigid wall, which leads to changes in pleural pressure and to expansion of the lung. Two specific complications occur, pneumothorax and reexpansion pulmonary edema. The images submitted for the Clinical Picture article by Drs. Apter and Aronowitz in this issue of the Journal highlight these complications.
Retrospective studies have found an association between the amount of fluid drained and the incidence of pneumothorax.1,2 Although technical issues may account for it (eg, needle injury to the lung that leads to postprocedural pneumothorax), the available evidence suggests that it has more to do with the drainage of larger volumes than the lung can expand to fill.3,4 That is, the patient’s lung cannot expand,5 so drainage creates a vacuum, and air enters the pleural space3 through the lung parenchyma, or perhaps from around the drainage catheter.
In a series of patients who underwent therapeutic thoracentesis,3 23 (8.7%) of 265 patients had pneumothorax. Interestingly, some patients had only symptoms, some had only excessively negative pressures (< 25 cm H2O), some had both, and some had neither. Thus, there does not seem to be a reliable sign or symptom of an unexpanding lung, but pleural manometry may help increase its detection.6 This technique, however, is rarely used in clinical practice.
Another consequence of therapeutic thoracentesis is reexpansion pulmonary edema. This rare condition occurs only after large-volume thoracentesis or evacuation of a moderate to large pneumothorax.7 The pathophysiology behind this is controversial.8 As with pneumothorax, a large case series did not find a correlation between volume removed or pleural pressures and reexpansion pulmonary edema.7 Experimental data and analysis of case series8–10 suggest that the duration of lung collapse and the speed of drainage and negative pressure applied contribute to the development of edema. Vacuum bottles are often used to speed drainage and to contain the large amount of fluid drained. These bottles have an initial negative pressure of about −723 mm Hg (personal communication with Baxter Healthcare Product information line), which may lead to rapid changes in lung volume and perhaps to higher negative pleural pressures.
Given the risks discussed above, we believe it is appropriate to avoid vacuum bottles and instead to use the syringe and one-way valve supplied in most thoracentesis kits. Further, pleural manometry to detect changes in pressure that suggest an unexpandable lung may lead to the appropriate early termination of a planned large-volume thoracentesis.3 The complications reported by Drs. Apter and Aronowitz are relatively rare and, at this point, unpredictable; therefore, generating high-quality evidence for prediction or management will be difficult. In the meantime, understanding the physiologic changes in the lung and the pleural space when draining large effusions from the chest may help avoid double trouble.
- Josephson T, Nordenskjold CA, Larsson J, Rosenberg LU, Kaijser M. Amount drained at ultrasound-guided thoracentesis and risk of pneumothorax. Acta Radiol 2009; 50:42–47.
- Gordon CE, Feller-Kopman D, Balk EM, Smetana GW. Pneumothorax following thoracentesis: a systematic review and meta-analysis. Arch Intern Med 2010; 170:332–339.
- Heidecker J, Huggins JT, Sahn SA, Doelken P. Pathophysiology of pneumothorax following ultrasound-guided thoracentesis. Chest 2006; 130:1173–1184.
- Huggins JT, Sahn SA, Heidecker J, Ravenel JG, Doelken P. Characteristics of trapped lung: pleural fluid analysis, manometry, and air-contrast chest CT. Chest 2007; 131:206–213.
- Woodring JH, Baker MD, Stark P. Pneumothorax ex vacuo. Chest 1996; 110:1102–1105.
- Feller-Kopman D. Therapeutic thoracentesis: the role of ultrasound and pleural manometry. Curr Opin Pulmon Med 2007; 13:312–318.
- Feller-Kopman D, Berkowitz D, Boiselle P, Ernst A. Large-volume thoracentesis and the risk of reexpansion pulmonary edema. Ann Thorac Surg 2007; 84:1656–1661.
- Tarver RD, Broderick LS, Conces DJ, Jr. Reexpansion pulmonary edema. J Thorac Imag 1996; 11:198–209.
- Murphy K, Tomlanovich MC. Unilateral pulmonary edema after drainage of a spontaneous pneumothorax: case report and review of the world literature. J Emerg Med 1983; 1:29–36.
- Pavlin J, Cheney FW Unilateral pulmonary edema in rabbits after reexpansion of collapsed lung. J Appl Physiol Respir Environ Exerc Physiol 1979; 46:31–35.
- Josephson T, Nordenskjold CA, Larsson J, Rosenberg LU, Kaijser M. Amount drained at ultrasound-guided thoracentesis and risk of pneumothorax. Acta Radiol 2009; 50:42–47.
- Gordon CE, Feller-Kopman D, Balk EM, Smetana GW. Pneumothorax following thoracentesis: a systematic review and meta-analysis. Arch Intern Med 2010; 170:332–339.
- Heidecker J, Huggins JT, Sahn SA, Doelken P. Pathophysiology of pneumothorax following ultrasound-guided thoracentesis. Chest 2006; 130:1173–1184.
- Huggins JT, Sahn SA, Heidecker J, Ravenel JG, Doelken P. Characteristics of trapped lung: pleural fluid analysis, manometry, and air-contrast chest CT. Chest 2007; 131:206–213.
- Woodring JH, Baker MD, Stark P. Pneumothorax ex vacuo. Chest 1996; 110:1102–1105.
- Feller-Kopman D. Therapeutic thoracentesis: the role of ultrasound and pleural manometry. Curr Opin Pulmon Med 2007; 13:312–318.
- Feller-Kopman D, Berkowitz D, Boiselle P, Ernst A. Large-volume thoracentesis and the risk of reexpansion pulmonary edema. Ann Thorac Surg 2007; 84:1656–1661.
- Tarver RD, Broderick LS, Conces DJ, Jr. Reexpansion pulmonary edema. J Thorac Imag 1996; 11:198–209.
- Murphy K, Tomlanovich MC. Unilateral pulmonary edema after drainage of a spontaneous pneumothorax: case report and review of the world literature. J Emerg Med 1983; 1:29–36.
- Pavlin J, Cheney FW Unilateral pulmonary edema in rabbits after reexpansion of collapsed lung. J Appl Physiol Respir Environ Exerc Physiol 1979; 46:31–35.
Stalled out
Am I the only person spooked by the way automation is taking over our public bathrooms? I appreciate some of this touch-free, infrared technology; I won’t always be nimble enough to push the flush lever with my right toe. But then I get that stall where Niagara Falls goes off every time I shift my weight. What is this, a bathroom or the Bellagio Fountains?
And darnit, people, if you're going to make the faucets automatic, can you please do the soap dispenser and paper towel roll, too? I feel like an idiot waving my hands around by the bathroom wall while the guy next to me walks up and yanks a towel off the roll. Then I smack my forehead with my wet hand, and I can't dry it without bending down under that motion-sensing ramjet thing that I should have used in the first place. The day I always feared has finally arrived: My bathroom is smarter than I am.
Playing by ear
I'm often frustrated but rarely surprised when the emergency department (ED) docs at our local hospital fail to follow basic pediatric treatment guidelines. Sore throat? Here’s some antibiotics. Runny nose? Antibiotics are good for that. Ankle sprain? Snake bite? Azithromycin for everyone! “If only,” I think, “we had a pediatric emergency department...at an academic medical center...in a more advanced country...with a public health system. ..."
But now, thanks to a new study from Sweden, my dreams are dashed. Apparently, even at an academic medical center with a pediatric ED in a country with public health care and that is capable of manufacturing affordable, sleek modern furniture that fits in the back of a station wagon and assembles in 5 minutes with a simple Allen wrench, even in freaking Sweden the ED docs overtreat acute otitis media (AOM) with antibiotics. And, according to author Jimmy Célind and his colleagues from the University of Gothenburg, they can't be stopped.
The investigators reviewed charts before and after a simple intervention to see if educating providers on evidence-based AOM guidelines would improve their compliance with those guidelines. The results? Not one outcome measure – use of drugs as opposed to nondrug management, choice of drug, drug dosage, or duration of drug treatment – improved.
The authors had several theories about why their intervention failed. The campaign consisted of one lecture and some fliers, without any ongoing monitoring and feedback. Providers were educated, but the patients were not. Patients were also in an ED, where people waited a long time to be seen and weren't keen to return in 2 days for follow-up. I have a different theory, however: They just forgot to include the Allen wrench.
The dark side of light
Here in North Carolina, a bill restricting teens' use of tanning beds appears to have stalled out in the legislature for a second year in a row, despite the success of such measures in states as diverse as Louisiana and Indiana (they both end with “ana,” but otherwise, they're diverse). I get it: Just because we keep teens from drinking, smoking, and driving, and just because tanning beds are a major cause of deadly cancer, there are also great reasons not to limit kids’ right to tan, like, um, where else can they wear those little dark eye cup things?
We've known for a while that using tanning beds increases kids' risk of developing deadly malignant melanoma, but a new study in Pediatrics adds basal cell carcinoma to the list, which is, to be fair, merely disfiguring. The study came from New Hampshire, a state which balances a paucity of intense sunlight with a rich supply of people who sunburn easily. Sunlamps, tanning beds, and tanning booths all increased the risk of cancer; kids who started tanning younger suffered more carcinoma.
None of these data are likely to impress opponents of laws limiting kids' use of tanning beds. “North Carolina shouldn't be a nanny state!”they'll shout. But when it comes to cancer, I disagree, at least when some of the people we're talking about still have an actual nanny.
My yellow stars!
Is it just me, or have sugary breakfast cereals become the latest punching bag of nutritionists and doctors? Only soft drinks and potato chips seem to draw as much blame for the obesity epidemic, although I had a slice of chocolate cake last night that I’d like to nominate for some serious scorn. Even the cereal makers didn’t see this next one coming, however. According the Environmental Working Group (EWG), this “nutritious part of a complete breakfast, fortified with vitamins and minerals” is too fortified with vitamins and minerals! Take that, you crispy flakes of morning goodness!
When it comes to vitamins and minerals, you really can have too much of a good thing, and the folks at the EWG make a compelling argument (strongly disputed by cereal manufacturers) that the levels of vitamin A, zinc, and niacin in many breakfast cereals actually pose a potential danger to kids’ health. Now, of course, I’m looking at the cereal boxes in my pantry and wondering what to do with them. I think I’ll go to a public restroom and ask the toilet.
David L. Hill, M.D., FAAP, is the author of Dad to Dad: Parenting Like a Pro (AAP Publishing, 2012). He is also vice president of Cape Fear Pediatrics in Wilmington, N.C., and adjunct assistant professor of pediatrics at the University of North Carolina at Chapel Hill. He serves as Program Director for the AAP Council on Communications and Media and as an executive committee member of the North Carolina Pediatric Society. He has recorded commentaries for NPR's All Things Considered and provided content for various print, television, and Internet outlets.
Am I the only person spooked by the way automation is taking over our public bathrooms? I appreciate some of this touch-free, infrared technology; I won’t always be nimble enough to push the flush lever with my right toe. But then I get that stall where Niagara Falls goes off every time I shift my weight. What is this, a bathroom or the Bellagio Fountains?
And darnit, people, if you're going to make the faucets automatic, can you please do the soap dispenser and paper towel roll, too? I feel like an idiot waving my hands around by the bathroom wall while the guy next to me walks up and yanks a towel off the roll. Then I smack my forehead with my wet hand, and I can't dry it without bending down under that motion-sensing ramjet thing that I should have used in the first place. The day I always feared has finally arrived: My bathroom is smarter than I am.
Playing by ear
I'm often frustrated but rarely surprised when the emergency department (ED) docs at our local hospital fail to follow basic pediatric treatment guidelines. Sore throat? Here’s some antibiotics. Runny nose? Antibiotics are good for that. Ankle sprain? Snake bite? Azithromycin for everyone! “If only,” I think, “we had a pediatric emergency department...at an academic medical center...in a more advanced country...with a public health system. ..."
But now, thanks to a new study from Sweden, my dreams are dashed. Apparently, even at an academic medical center with a pediatric ED in a country with public health care and that is capable of manufacturing affordable, sleek modern furniture that fits in the back of a station wagon and assembles in 5 minutes with a simple Allen wrench, even in freaking Sweden the ED docs overtreat acute otitis media (AOM) with antibiotics. And, according to author Jimmy Célind and his colleagues from the University of Gothenburg, they can't be stopped.
The investigators reviewed charts before and after a simple intervention to see if educating providers on evidence-based AOM guidelines would improve their compliance with those guidelines. The results? Not one outcome measure – use of drugs as opposed to nondrug management, choice of drug, drug dosage, or duration of drug treatment – improved.
The authors had several theories about why their intervention failed. The campaign consisted of one lecture and some fliers, without any ongoing monitoring and feedback. Providers were educated, but the patients were not. Patients were also in an ED, where people waited a long time to be seen and weren't keen to return in 2 days for follow-up. I have a different theory, however: They just forgot to include the Allen wrench.
The dark side of light
Here in North Carolina, a bill restricting teens' use of tanning beds appears to have stalled out in the legislature for a second year in a row, despite the success of such measures in states as diverse as Louisiana and Indiana (they both end with “ana,” but otherwise, they're diverse). I get it: Just because we keep teens from drinking, smoking, and driving, and just because tanning beds are a major cause of deadly cancer, there are also great reasons not to limit kids’ right to tan, like, um, where else can they wear those little dark eye cup things?
We've known for a while that using tanning beds increases kids' risk of developing deadly malignant melanoma, but a new study in Pediatrics adds basal cell carcinoma to the list, which is, to be fair, merely disfiguring. The study came from New Hampshire, a state which balances a paucity of intense sunlight with a rich supply of people who sunburn easily. Sunlamps, tanning beds, and tanning booths all increased the risk of cancer; kids who started tanning younger suffered more carcinoma.
None of these data are likely to impress opponents of laws limiting kids' use of tanning beds. “North Carolina shouldn't be a nanny state!”they'll shout. But when it comes to cancer, I disagree, at least when some of the people we're talking about still have an actual nanny.
My yellow stars!
Is it just me, or have sugary breakfast cereals become the latest punching bag of nutritionists and doctors? Only soft drinks and potato chips seem to draw as much blame for the obesity epidemic, although I had a slice of chocolate cake last night that I’d like to nominate for some serious scorn. Even the cereal makers didn’t see this next one coming, however. According the Environmental Working Group (EWG), this “nutritious part of a complete breakfast, fortified with vitamins and minerals” is too fortified with vitamins and minerals! Take that, you crispy flakes of morning goodness!
When it comes to vitamins and minerals, you really can have too much of a good thing, and the folks at the EWG make a compelling argument (strongly disputed by cereal manufacturers) that the levels of vitamin A, zinc, and niacin in many breakfast cereals actually pose a potential danger to kids’ health. Now, of course, I’m looking at the cereal boxes in my pantry and wondering what to do with them. I think I’ll go to a public restroom and ask the toilet.
David L. Hill, M.D., FAAP, is the author of Dad to Dad: Parenting Like a Pro (AAP Publishing, 2012). He is also vice president of Cape Fear Pediatrics in Wilmington, N.C., and adjunct assistant professor of pediatrics at the University of North Carolina at Chapel Hill. He serves as Program Director for the AAP Council on Communications and Media and as an executive committee member of the North Carolina Pediatric Society. He has recorded commentaries for NPR's All Things Considered and provided content for various print, television, and Internet outlets.
Am I the only person spooked by the way automation is taking over our public bathrooms? I appreciate some of this touch-free, infrared technology; I won’t always be nimble enough to push the flush lever with my right toe. But then I get that stall where Niagara Falls goes off every time I shift my weight. What is this, a bathroom or the Bellagio Fountains?
And darnit, people, if you're going to make the faucets automatic, can you please do the soap dispenser and paper towel roll, too? I feel like an idiot waving my hands around by the bathroom wall while the guy next to me walks up and yanks a towel off the roll. Then I smack my forehead with my wet hand, and I can't dry it without bending down under that motion-sensing ramjet thing that I should have used in the first place. The day I always feared has finally arrived: My bathroom is smarter than I am.
Playing by ear
I'm often frustrated but rarely surprised when the emergency department (ED) docs at our local hospital fail to follow basic pediatric treatment guidelines. Sore throat? Here’s some antibiotics. Runny nose? Antibiotics are good for that. Ankle sprain? Snake bite? Azithromycin for everyone! “If only,” I think, “we had a pediatric emergency department...at an academic medical center...in a more advanced country...with a public health system. ..."
But now, thanks to a new study from Sweden, my dreams are dashed. Apparently, even at an academic medical center with a pediatric ED in a country with public health care and that is capable of manufacturing affordable, sleek modern furniture that fits in the back of a station wagon and assembles in 5 minutes with a simple Allen wrench, even in freaking Sweden the ED docs overtreat acute otitis media (AOM) with antibiotics. And, according to author Jimmy Célind and his colleagues from the University of Gothenburg, they can't be stopped.
The investigators reviewed charts before and after a simple intervention to see if educating providers on evidence-based AOM guidelines would improve their compliance with those guidelines. The results? Not one outcome measure – use of drugs as opposed to nondrug management, choice of drug, drug dosage, or duration of drug treatment – improved.
The authors had several theories about why their intervention failed. The campaign consisted of one lecture and some fliers, without any ongoing monitoring and feedback. Providers were educated, but the patients were not. Patients were also in an ED, where people waited a long time to be seen and weren't keen to return in 2 days for follow-up. I have a different theory, however: They just forgot to include the Allen wrench.
The dark side of light
Here in North Carolina, a bill restricting teens' use of tanning beds appears to have stalled out in the legislature for a second year in a row, despite the success of such measures in states as diverse as Louisiana and Indiana (they both end with “ana,” but otherwise, they're diverse). I get it: Just because we keep teens from drinking, smoking, and driving, and just because tanning beds are a major cause of deadly cancer, there are also great reasons not to limit kids’ right to tan, like, um, where else can they wear those little dark eye cup things?
We've known for a while that using tanning beds increases kids' risk of developing deadly malignant melanoma, but a new study in Pediatrics adds basal cell carcinoma to the list, which is, to be fair, merely disfiguring. The study came from New Hampshire, a state which balances a paucity of intense sunlight with a rich supply of people who sunburn easily. Sunlamps, tanning beds, and tanning booths all increased the risk of cancer; kids who started tanning younger suffered more carcinoma.
None of these data are likely to impress opponents of laws limiting kids' use of tanning beds. “North Carolina shouldn't be a nanny state!”they'll shout. But when it comes to cancer, I disagree, at least when some of the people we're talking about still have an actual nanny.
My yellow stars!
Is it just me, or have sugary breakfast cereals become the latest punching bag of nutritionists and doctors? Only soft drinks and potato chips seem to draw as much blame for the obesity epidemic, although I had a slice of chocolate cake last night that I’d like to nominate for some serious scorn. Even the cereal makers didn’t see this next one coming, however. According the Environmental Working Group (EWG), this “nutritious part of a complete breakfast, fortified with vitamins and minerals” is too fortified with vitamins and minerals! Take that, you crispy flakes of morning goodness!
When it comes to vitamins and minerals, you really can have too much of a good thing, and the folks at the EWG make a compelling argument (strongly disputed by cereal manufacturers) that the levels of vitamin A, zinc, and niacin in many breakfast cereals actually pose a potential danger to kids’ health. Now, of course, I’m looking at the cereal boxes in my pantry and wondering what to do with them. I think I’ll go to a public restroom and ask the toilet.
David L. Hill, M.D., FAAP, is the author of Dad to Dad: Parenting Like a Pro (AAP Publishing, 2012). He is also vice president of Cape Fear Pediatrics in Wilmington, N.C., and adjunct assistant professor of pediatrics at the University of North Carolina at Chapel Hill. He serves as Program Director for the AAP Council on Communications and Media and as an executive committee member of the North Carolina Pediatric Society. He has recorded commentaries for NPR's All Things Considered and provided content for various print, television, and Internet outlets.
New York’s ambitious agenda seeks to end the HIV epidemic
Not every day does an elected politician turn public health hero, but that happened when New York Governor Andrew Cuomo on June 29 announced an ambitious plan to identify all New York state residents who are infected with HIV, and start them on effective treatment. The goal is that by 2020 the number of HIV patients in New York will finally start to drop, and the HIV epidemic will end, at least in New York.
The program was announced in a press release and by Mr. Cuomo before the start of the annual New York City Gay Pride March on June 29. The three-point program is dubbed Bending the Curve, an epidemiologic and public health concept of HIV that has kicked around the infectious diseases community for several years. The idea is that with today’s highly active antiretroviral therapy – with high efficacy for controlling viral load, low toxicity, and a low daily pill count – the amount of HIV circulating in infected patients can be maintained at undetectable levels, rendering the patient noninfectious.
I heard the National Institutes of Health’s Dr. Anthony Fauci, longtime leader of federally funded U.S. efforts to control HIV, present this concept at a meeting a year ago, but at the time, this great idea was just that, a concept not yet being attempted in real life.
New York’s move makes it the first U.S. jurisdiction to adopt early, aggressive treatment as a public health mandate, serving as a tryout for a highly sensible hypothesis.
Speaking to the New York Times on June 26, when word of the New York initiative first came out, Dr. Fauci commented that it would serve as a national model, and that "if you aggressively seek out people who are infected, [and] get them into voluntary testing, care, and treatment, the mathematical model shows a sharp deflection in the curve of people ultimately getting the infection. Ultimately, you can end the pandemic."
The New York program aims to do this with an aggressive program of testing and treatment paid for by the state, which has worked out a deal with a trio of drug companies to buy state-of-the-art HIV drugs at a reduced price. The program also calls for more extensive promotion of and state payment for pre-exposure prophylaxis treatment. The governor’s statement did not put a price tag on what this will cost New York, but it emphasized that substantial cost savings will result from cutting new HIV infections.
As the Times’ coverage highlighted, the program is no slam dunk. It’s a great idea that will surely encounter logistic issues. But it received praise and support from leaders of several constituency groups, a key factor that should help it succeed. For example, the statement announcing the program quoted Benjamin Bashein, acting executive director of the AIDS Community Research Initiative of America, as saying, "ACRIA applauds Governor Cuomo for his bold plan to end AIDS in New York state. We now have the knowledge and the means to dramatically reduce new infections and promote optimal health for those with HIV. Governor Cuomo’s leadership will make New York a model for ending AIDS across the country and around the globe."
On Twitter @mitchelzoler
Not every day does an elected politician turn public health hero, but that happened when New York Governor Andrew Cuomo on June 29 announced an ambitious plan to identify all New York state residents who are infected with HIV, and start them on effective treatment. The goal is that by 2020 the number of HIV patients in New York will finally start to drop, and the HIV epidemic will end, at least in New York.
The program was announced in a press release and by Mr. Cuomo before the start of the annual New York City Gay Pride March on June 29. The three-point program is dubbed Bending the Curve, an epidemiologic and public health concept of HIV that has kicked around the infectious diseases community for several years. The idea is that with today’s highly active antiretroviral therapy – with high efficacy for controlling viral load, low toxicity, and a low daily pill count – the amount of HIV circulating in infected patients can be maintained at undetectable levels, rendering the patient noninfectious.
I heard the National Institutes of Health’s Dr. Anthony Fauci, longtime leader of federally funded U.S. efforts to control HIV, present this concept at a meeting a year ago, but at the time, this great idea was just that, a concept not yet being attempted in real life.
New York’s move makes it the first U.S. jurisdiction to adopt early, aggressive treatment as a public health mandate, serving as a tryout for a highly sensible hypothesis.
Speaking to the New York Times on June 26, when word of the New York initiative first came out, Dr. Fauci commented that it would serve as a national model, and that "if you aggressively seek out people who are infected, [and] get them into voluntary testing, care, and treatment, the mathematical model shows a sharp deflection in the curve of people ultimately getting the infection. Ultimately, you can end the pandemic."
The New York program aims to do this with an aggressive program of testing and treatment paid for by the state, which has worked out a deal with a trio of drug companies to buy state-of-the-art HIV drugs at a reduced price. The program also calls for more extensive promotion of and state payment for pre-exposure prophylaxis treatment. The governor’s statement did not put a price tag on what this will cost New York, but it emphasized that substantial cost savings will result from cutting new HIV infections.
As the Times’ coverage highlighted, the program is no slam dunk. It’s a great idea that will surely encounter logistic issues. But it received praise and support from leaders of several constituency groups, a key factor that should help it succeed. For example, the statement announcing the program quoted Benjamin Bashein, acting executive director of the AIDS Community Research Initiative of America, as saying, "ACRIA applauds Governor Cuomo for his bold plan to end AIDS in New York state. We now have the knowledge and the means to dramatically reduce new infections and promote optimal health for those with HIV. Governor Cuomo’s leadership will make New York a model for ending AIDS across the country and around the globe."
On Twitter @mitchelzoler
Not every day does an elected politician turn public health hero, but that happened when New York Governor Andrew Cuomo on June 29 announced an ambitious plan to identify all New York state residents who are infected with HIV, and start them on effective treatment. The goal is that by 2020 the number of HIV patients in New York will finally start to drop, and the HIV epidemic will end, at least in New York.
The program was announced in a press release and by Mr. Cuomo before the start of the annual New York City Gay Pride March on June 29. The three-point program is dubbed Bending the Curve, an epidemiologic and public health concept of HIV that has kicked around the infectious diseases community for several years. The idea is that with today’s highly active antiretroviral therapy – with high efficacy for controlling viral load, low toxicity, and a low daily pill count – the amount of HIV circulating in infected patients can be maintained at undetectable levels, rendering the patient noninfectious.
I heard the National Institutes of Health’s Dr. Anthony Fauci, longtime leader of federally funded U.S. efforts to control HIV, present this concept at a meeting a year ago, but at the time, this great idea was just that, a concept not yet being attempted in real life.
New York’s move makes it the first U.S. jurisdiction to adopt early, aggressive treatment as a public health mandate, serving as a tryout for a highly sensible hypothesis.
Speaking to the New York Times on June 26, when word of the New York initiative first came out, Dr. Fauci commented that it would serve as a national model, and that "if you aggressively seek out people who are infected, [and] get them into voluntary testing, care, and treatment, the mathematical model shows a sharp deflection in the curve of people ultimately getting the infection. Ultimately, you can end the pandemic."
The New York program aims to do this with an aggressive program of testing and treatment paid for by the state, which has worked out a deal with a trio of drug companies to buy state-of-the-art HIV drugs at a reduced price. The program also calls for more extensive promotion of and state payment for pre-exposure prophylaxis treatment. The governor’s statement did not put a price tag on what this will cost New York, but it emphasized that substantial cost savings will result from cutting new HIV infections.
As the Times’ coverage highlighted, the program is no slam dunk. It’s a great idea that will surely encounter logistic issues. But it received praise and support from leaders of several constituency groups, a key factor that should help it succeed. For example, the statement announcing the program quoted Benjamin Bashein, acting executive director of the AIDS Community Research Initiative of America, as saying, "ACRIA applauds Governor Cuomo for his bold plan to end AIDS in New York state. We now have the knowledge and the means to dramatically reduce new infections and promote optimal health for those with HIV. Governor Cuomo’s leadership will make New York a model for ending AIDS across the country and around the globe."
On Twitter @mitchelzoler
The give and take on explaining drug side effects
"What are the side effects?" How many times a day do you get asked that? Plenty, I’m sure. I certainly hear it.
The list of side effects (small print on the product insert) is enormous. No one can possibly cover them in the few minutes we have during a visit, so I just try to hit the ones that are most likely and those that are most serious.
Of course, most patients still go home and look them up. The majority of patients are fine with it, but some immediately develop every side effect imaginable through the power of suggestion. While I’m all for "empowered patients," the Internet is full of both useful and insanely inaccurate information. It’s often hard to tell them apart.
I still get asked for drugs "without any side effects" and try to explain that there is no such thing and never will be. The vagaries of human biochemistry are such that everyone will have a negative reaction to something sooner or later. And it generally can’t be predicted in advance.
I try to reassure people that just because a drug can cause an adverse reaction doesn’t mean that it will. I explain how most side effects were reported in a minority of patients, go over how the data are collected during trials, and so on. Most people are reasonable and understand that there’s a benefit-to-risk calculation we’re making, like anything else.
But some patients are quite adamant that as long as there’s even the slightest chance of them having a side effect, they don’t want to take it. They want help, but won’t let me help them. Those appointments are frustrating and make me wonder why the patient bothered to come in at all. They’re the reason I keep a wand next to my desk.
There is no shortage of treatments for at least some of the many conditions that neurologists treat, but at the same time there is always the chance that side effects will occur. Medicine, like everything else in life, has benefits and risks.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
"What are the side effects?" How many times a day do you get asked that? Plenty, I’m sure. I certainly hear it.
The list of side effects (small print on the product insert) is enormous. No one can possibly cover them in the few minutes we have during a visit, so I just try to hit the ones that are most likely and those that are most serious.
Of course, most patients still go home and look them up. The majority of patients are fine with it, but some immediately develop every side effect imaginable through the power of suggestion. While I’m all for "empowered patients," the Internet is full of both useful and insanely inaccurate information. It’s often hard to tell them apart.
I still get asked for drugs "without any side effects" and try to explain that there is no such thing and never will be. The vagaries of human biochemistry are such that everyone will have a negative reaction to something sooner or later. And it generally can’t be predicted in advance.
I try to reassure people that just because a drug can cause an adverse reaction doesn’t mean that it will. I explain how most side effects were reported in a minority of patients, go over how the data are collected during trials, and so on. Most people are reasonable and understand that there’s a benefit-to-risk calculation we’re making, like anything else.
But some patients are quite adamant that as long as there’s even the slightest chance of them having a side effect, they don’t want to take it. They want help, but won’t let me help them. Those appointments are frustrating and make me wonder why the patient bothered to come in at all. They’re the reason I keep a wand next to my desk.
There is no shortage of treatments for at least some of the many conditions that neurologists treat, but at the same time there is always the chance that side effects will occur. Medicine, like everything else in life, has benefits and risks.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
"What are the side effects?" How many times a day do you get asked that? Plenty, I’m sure. I certainly hear it.
The list of side effects (small print on the product insert) is enormous. No one can possibly cover them in the few minutes we have during a visit, so I just try to hit the ones that are most likely and those that are most serious.
Of course, most patients still go home and look them up. The majority of patients are fine with it, but some immediately develop every side effect imaginable through the power of suggestion. While I’m all for "empowered patients," the Internet is full of both useful and insanely inaccurate information. It’s often hard to tell them apart.
I still get asked for drugs "without any side effects" and try to explain that there is no such thing and never will be. The vagaries of human biochemistry are such that everyone will have a negative reaction to something sooner or later. And it generally can’t be predicted in advance.
I try to reassure people that just because a drug can cause an adverse reaction doesn’t mean that it will. I explain how most side effects were reported in a minority of patients, go over how the data are collected during trials, and so on. Most people are reasonable and understand that there’s a benefit-to-risk calculation we’re making, like anything else.
But some patients are quite adamant that as long as there’s even the slightest chance of them having a side effect, they don’t want to take it. They want help, but won’t let me help them. Those appointments are frustrating and make me wonder why the patient bothered to come in at all. They’re the reason I keep a wand next to my desk.
There is no shortage of treatments for at least some of the many conditions that neurologists treat, but at the same time there is always the chance that side effects will occur. Medicine, like everything else in life, has benefits and risks.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Enigmatic inconsistencies between WHI data and conclusions; Exaggerated or intentionally fabricated data?
Enigmatic inconsistencies between WHI data and conclusions
The issue of the inconsistencies between the Women’s Health Initiative (WHI) data and conclusions is enigmatic because the integrity and judgment of researchers has in the past and should remain above reproach.
For those of us in the private sector of obstetrics and gynecology, the feeling that there must be information that intentionally or unintentionally has been omitted from our view remains the most comfortable and convenient explanation for the discrepancies.
The vindication of observational studies predating WHI by the reanalysis of WHI data seems to be continually suppressed in the literature, and the unreasoning exclusion of the critical issue of timing in the initiation and continued administration of estrogen therapy (ET) and hormone therapy (HT) is inexplicable. One is repeatedly tempted to consider some underlying agenda.
Elimination of sampling by Wyeth, and now exclusion from drug formularies with the attendant exorbitant increases in cost have, in addition to the absence of a defense by researchers or manufacturers, discouraged continuing use of this valuable medication, even among those in whom the safety and benefits of Premarin and Prempro have been established over years of experience and scores of studies.
It is much like the children’s story, “The Emperor’s New Clothes.” It seems incredible that so many knowledgeable authorities seem unable to recognize a 60% reduction in coronary artery plaque in recently menopausal women (ages 50–59 years) after 5.2 years of HT, which underscores the importance of patient selection and timing of administration.1 Wyeth’s explanation, when I inquired, was that this involved “off-label” use, although the data are from reanalysis of WHI data. I would think that a 60% reduction of arterial plaque deserves front-page coverage.
When articles about the discontinuation of WHI began to appear in 2001, stated reasons included the overwhelming predominance of new breast cancer cases in estrogen-administered subjects, but no one seems to appreciate the 47% decrease in breast cancer mortality discovered in the reanalysis, due to the chronologically earlier appearance of disease at earlier clinical stages. In my practice, we are finding in situ disease in HT and ET patients after 4 to 5 years of use.
Consequently, I am appreciative of Dr. Thacker’s mention of the Sarrel data2 and her expansion into the “so often” overlooked issues. I think that it’s overdue—integrity must be restored to the interpretation of NIH’s $780,000,000 expenditure of taxpayer dollars. After all, WHI was to be the statistically unimpeachable clarification of estrogen and hormone replacement.
Glenn N. Hayashi, MD
Honolulu, Hawaii
Exaggerated or intentionally fabricated data?
Thank you for publishing Dr. Holly Thacker’s commentary regarding the travesty that was and is WHI. I enthusiastically support her admonition to “look at the totality of the data on menopausal HT, evaluate our patients individually, treat those who are truly hormonally deficient and suffering, and counsel them that many of the harms linked to HT have been exaggerated.”
My only disagreement is Dr. Thacker’s choice of the word “exaggerated” when describing the harms linked to HT. I would have chosen instead the words “intentionally fabricated.” How? By taking data out of context, by releasing data selectively, by withholding data—all for the purpose of achieving and then protecting their frighteningly negative and destructive initial conclusions.
I wish it were the case that an independent commission might right these wrongs. Unfortunately, that cannot happen in today’s intellectual context. The fundamental error that made WHI’s multitude of errors possible was the notion that we can dispense with the difficult work of considering “the totality of the data” by placing our faith in “statistical significance” derived from a single “randomized controlled trial.” That fundamental error is too deeply entrenched, too highly remunerative, and too propitiously useful to those seeking a world concordant with their fantasies.
Reality demands that we account for every fact and will in time put an end to this deadly conceit.
Geoffrey C. Kincaid, MD
Knoxville, Tennessee
TELL US WHAT YOU THINK! Drop us a line and let us know what you think about this or other current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: [email protected] Please include your name, city and state. Stay in touch! Your feedback is important to us!
1. Manson JE, Allison MA, Rossouw JE, et al; WHI and WHI-CACS Investigators. Estrogen therapy and coronary-artery calcification. N Engl J Med. 2007;356(25):2591–2602.
2. Sarrel PM, Njike VY, Vinante V, Katz DL. The mortality toll of estrogen avoidance: an analysis of excess deaths among hysterectomized women aged 50 to 59. Am J Pub Health. 2013;103(9):1583–1588.
Enigmatic inconsistencies between WHI data and conclusions
The issue of the inconsistencies between the Women’s Health Initiative (WHI) data and conclusions is enigmatic because the integrity and judgment of researchers has in the past and should remain above reproach.
For those of us in the private sector of obstetrics and gynecology, the feeling that there must be information that intentionally or unintentionally has been omitted from our view remains the most comfortable and convenient explanation for the discrepancies.
The vindication of observational studies predating WHI by the reanalysis of WHI data seems to be continually suppressed in the literature, and the unreasoning exclusion of the critical issue of timing in the initiation and continued administration of estrogen therapy (ET) and hormone therapy (HT) is inexplicable. One is repeatedly tempted to consider some underlying agenda.
Elimination of sampling by Wyeth, and now exclusion from drug formularies with the attendant exorbitant increases in cost have, in addition to the absence of a defense by researchers or manufacturers, discouraged continuing use of this valuable medication, even among those in whom the safety and benefits of Premarin and Prempro have been established over years of experience and scores of studies.
It is much like the children’s story, “The Emperor’s New Clothes.” It seems incredible that so many knowledgeable authorities seem unable to recognize a 60% reduction in coronary artery plaque in recently menopausal women (ages 50–59 years) after 5.2 years of HT, which underscores the importance of patient selection and timing of administration.1 Wyeth’s explanation, when I inquired, was that this involved “off-label” use, although the data are from reanalysis of WHI data. I would think that a 60% reduction of arterial plaque deserves front-page coverage.
When articles about the discontinuation of WHI began to appear in 2001, stated reasons included the overwhelming predominance of new breast cancer cases in estrogen-administered subjects, but no one seems to appreciate the 47% decrease in breast cancer mortality discovered in the reanalysis, due to the chronologically earlier appearance of disease at earlier clinical stages. In my practice, we are finding in situ disease in HT and ET patients after 4 to 5 years of use.
Consequently, I am appreciative of Dr. Thacker’s mention of the Sarrel data2 and her expansion into the “so often” overlooked issues. I think that it’s overdue—integrity must be restored to the interpretation of NIH’s $780,000,000 expenditure of taxpayer dollars. After all, WHI was to be the statistically unimpeachable clarification of estrogen and hormone replacement.
Glenn N. Hayashi, MD
Honolulu, Hawaii
Exaggerated or intentionally fabricated data?
Thank you for publishing Dr. Holly Thacker’s commentary regarding the travesty that was and is WHI. I enthusiastically support her admonition to “look at the totality of the data on menopausal HT, evaluate our patients individually, treat those who are truly hormonally deficient and suffering, and counsel them that many of the harms linked to HT have been exaggerated.”
My only disagreement is Dr. Thacker’s choice of the word “exaggerated” when describing the harms linked to HT. I would have chosen instead the words “intentionally fabricated.” How? By taking data out of context, by releasing data selectively, by withholding data—all for the purpose of achieving and then protecting their frighteningly negative and destructive initial conclusions.
I wish it were the case that an independent commission might right these wrongs. Unfortunately, that cannot happen in today’s intellectual context. The fundamental error that made WHI’s multitude of errors possible was the notion that we can dispense with the difficult work of considering “the totality of the data” by placing our faith in “statistical significance” derived from a single “randomized controlled trial.” That fundamental error is too deeply entrenched, too highly remunerative, and too propitiously useful to those seeking a world concordant with their fantasies.
Reality demands that we account for every fact and will in time put an end to this deadly conceit.
Geoffrey C. Kincaid, MD
Knoxville, Tennessee
TELL US WHAT YOU THINK! Drop us a line and let us know what you think about this or other current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: [email protected] Please include your name, city and state. Stay in touch! Your feedback is important to us!
Enigmatic inconsistencies between WHI data and conclusions
The issue of the inconsistencies between the Women’s Health Initiative (WHI) data and conclusions is enigmatic because the integrity and judgment of researchers has in the past and should remain above reproach.
For those of us in the private sector of obstetrics and gynecology, the feeling that there must be information that intentionally or unintentionally has been omitted from our view remains the most comfortable and convenient explanation for the discrepancies.
The vindication of observational studies predating WHI by the reanalysis of WHI data seems to be continually suppressed in the literature, and the unreasoning exclusion of the critical issue of timing in the initiation and continued administration of estrogen therapy (ET) and hormone therapy (HT) is inexplicable. One is repeatedly tempted to consider some underlying agenda.
Elimination of sampling by Wyeth, and now exclusion from drug formularies with the attendant exorbitant increases in cost have, in addition to the absence of a defense by researchers or manufacturers, discouraged continuing use of this valuable medication, even among those in whom the safety and benefits of Premarin and Prempro have been established over years of experience and scores of studies.
It is much like the children’s story, “The Emperor’s New Clothes.” It seems incredible that so many knowledgeable authorities seem unable to recognize a 60% reduction in coronary artery plaque in recently menopausal women (ages 50–59 years) after 5.2 years of HT, which underscores the importance of patient selection and timing of administration.1 Wyeth’s explanation, when I inquired, was that this involved “off-label” use, although the data are from reanalysis of WHI data. I would think that a 60% reduction of arterial plaque deserves front-page coverage.
When articles about the discontinuation of WHI began to appear in 2001, stated reasons included the overwhelming predominance of new breast cancer cases in estrogen-administered subjects, but no one seems to appreciate the 47% decrease in breast cancer mortality discovered in the reanalysis, due to the chronologically earlier appearance of disease at earlier clinical stages. In my practice, we are finding in situ disease in HT and ET patients after 4 to 5 years of use.
Consequently, I am appreciative of Dr. Thacker’s mention of the Sarrel data2 and her expansion into the “so often” overlooked issues. I think that it’s overdue—integrity must be restored to the interpretation of NIH’s $780,000,000 expenditure of taxpayer dollars. After all, WHI was to be the statistically unimpeachable clarification of estrogen and hormone replacement.
Glenn N. Hayashi, MD
Honolulu, Hawaii
Exaggerated or intentionally fabricated data?
Thank you for publishing Dr. Holly Thacker’s commentary regarding the travesty that was and is WHI. I enthusiastically support her admonition to “look at the totality of the data on menopausal HT, evaluate our patients individually, treat those who are truly hormonally deficient and suffering, and counsel them that many of the harms linked to HT have been exaggerated.”
My only disagreement is Dr. Thacker’s choice of the word “exaggerated” when describing the harms linked to HT. I would have chosen instead the words “intentionally fabricated.” How? By taking data out of context, by releasing data selectively, by withholding data—all for the purpose of achieving and then protecting their frighteningly negative and destructive initial conclusions.
I wish it were the case that an independent commission might right these wrongs. Unfortunately, that cannot happen in today’s intellectual context. The fundamental error that made WHI’s multitude of errors possible was the notion that we can dispense with the difficult work of considering “the totality of the data” by placing our faith in “statistical significance” derived from a single “randomized controlled trial.” That fundamental error is too deeply entrenched, too highly remunerative, and too propitiously useful to those seeking a world concordant with their fantasies.
Reality demands that we account for every fact and will in time put an end to this deadly conceit.
Geoffrey C. Kincaid, MD
Knoxville, Tennessee
TELL US WHAT YOU THINK! Drop us a line and let us know what you think about this or other current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: [email protected] Please include your name, city and state. Stay in touch! Your feedback is important to us!
1. Manson JE, Allison MA, Rossouw JE, et al; WHI and WHI-CACS Investigators. Estrogen therapy and coronary-artery calcification. N Engl J Med. 2007;356(25):2591–2602.
2. Sarrel PM, Njike VY, Vinante V, Katz DL. The mortality toll of estrogen avoidance: an analysis of excess deaths among hysterectomized women aged 50 to 59. Am J Pub Health. 2013;103(9):1583–1588.
1. Manson JE, Allison MA, Rossouw JE, et al; WHI and WHI-CACS Investigators. Estrogen therapy and coronary-artery calcification. N Engl J Med. 2007;356(25):2591–2602.
2. Sarrel PM, Njike VY, Vinante V, Katz DL. The mortality toll of estrogen avoidance: an analysis of excess deaths among hysterectomized women aged 50 to 59. Am J Pub Health. 2013;103(9):1583–1588.
Mobile interventions boost diabetes care
Mobile app interventions for people with diabetes improved glycemic control in separate studies reported at the annual scientific sessions of the American Diabetes Association, San Francisco.
Interim results from a prospective randomized controlled study of 106 patients from a medically underserved Hispanic population with poorly controlled type 2 diabetes found that hemoglobin A1c (HbA1c) levels decreased by an average of a relative 12% after 6 months in those who used a text-messaging intervention called Dulce Digital on their mobile phones in addition to receiving usual care, compared with a 2% relative decrease in the control patients who received usual care alone.
Mean HbA1c levels decreased from 9.4% at baseline in the Dulce Digital group to 8.4% after 3 months and at 6 months. In the control group, mean HbA1c levels started at 9.5%, decreased to 9.2% at 3 months, and increased to 9.3% at 6 months. The differences between groups were statistically significant, nurse practitioner Maria Isabel Garcia reported.
Changes in other measures, including weight, blood pressure, or lipids, did not differ significantly between groups, said Ms. Garcia of Scripps Health, San Diego.
Patients in the Dulce Digital group who had no cell phone or had limited text-messaging service, received a phone with unlimited messaging. They then received two or three texts per day initially, with the frequency tapering over a 6-month period. Three kinds of texts were sent. Educational messages included a reminder to "Use small plates! Portions will look larger, and you may feel more satisfied after eating." Medication reminders might say, "Tick, tock. Take your medication at the same time every day!" Blood glucose prompts reminded patients, "Time to check your blood sugar! Text back your results."
Nurses monitored blood glucose responses and called the patient if they saw one reported value greater than 250 mg/L or less than 70 mg/dL, three values in the 181- to 250-mg/dL range within 1 month, or no texts back for 1 week.
"Ninety-one percent of the U.S. population already has a cell phone. So let’s use that as a way to circumvent these barriers to access to care," Ms. Garcia said. She and her associates are pursuing funding for further study of Dulce Digital with longer follow-up.
In a separate randomized, controlled French study of 190 adults with type 2 diabetes who were starting insulin, the Telediab2 software system loaded onto patients’ phones nearly doubled the likelihood that patients would achieve HbA1c levels of less than 7% by 13 months (31%), compared with patients in a control group or a third group who used a simplified software intervention for only the first 4 months (19%), Dr. Sylvia Franc reported in a poster presentation.
The TeleDiab2 system provides automatic basal insulin titration based on blood glucose targets and rules devised by the treating physician, as well as automatic personalized coaching for blood glucose monitoring, diet, and physical activity based on pre- and postprandial blood glucose values. The app enables remote telemonitoring and short teleconsultations, said Dr. Franc of Sud-Francilien Hospital, Corbeil Essones, France.
Physicians initiated and titrated basal insulin at baseline. Patients in the control group then received face-to-face consultations every 3 months. The simplified intervention group received phone consultations through the app for the first 4 months (and had significantly improved HbA1c levels, compared with the control group, in that period), then had face-to-face visits every 3 months. Patients in the Telediab2 group had no face-to-face visits; they had phone consultations every 2 weeks until month 4, then monthly phone consultations.
Mobile technology also impressed attendees at the meeting in four small studies showing progress in early attempts to develop an "artificial pancreas." In two 5-day crossover studies, 52 U.S. adults and adolescents with type 1 diabetes using a bionic insulin-glucagon pancreas achieved better glycemic control than did patients using insulin pump therapy (N. Engl. J. Med. 2014 June 15 [doi:10.1056/NEJMoa1314474]). The FlorenceD2 closed-loop insulin delivery system seemed to improve glucose control when used by patients at home in two small European randomized crossover studies.
Dr. Garcia and Dr. Franc reported having no financial disclosures. Lifescan, which sells glucose monitoring products, supported Dr. Garcia’s study.
On Twitter @SherryBoschert
Mobile app interventions for people with diabetes improved glycemic control in separate studies reported at the annual scientific sessions of the American Diabetes Association, San Francisco.
Interim results from a prospective randomized controlled study of 106 patients from a medically underserved Hispanic population with poorly controlled type 2 diabetes found that hemoglobin A1c (HbA1c) levels decreased by an average of a relative 12% after 6 months in those who used a text-messaging intervention called Dulce Digital on their mobile phones in addition to receiving usual care, compared with a 2% relative decrease in the control patients who received usual care alone.
Mean HbA1c levels decreased from 9.4% at baseline in the Dulce Digital group to 8.4% after 3 months and at 6 months. In the control group, mean HbA1c levels started at 9.5%, decreased to 9.2% at 3 months, and increased to 9.3% at 6 months. The differences between groups were statistically significant, nurse practitioner Maria Isabel Garcia reported.
Changes in other measures, including weight, blood pressure, or lipids, did not differ significantly between groups, said Ms. Garcia of Scripps Health, San Diego.
Patients in the Dulce Digital group who had no cell phone or had limited text-messaging service, received a phone with unlimited messaging. They then received two or three texts per day initially, with the frequency tapering over a 6-month period. Three kinds of texts were sent. Educational messages included a reminder to "Use small plates! Portions will look larger, and you may feel more satisfied after eating." Medication reminders might say, "Tick, tock. Take your medication at the same time every day!" Blood glucose prompts reminded patients, "Time to check your blood sugar! Text back your results."
Nurses monitored blood glucose responses and called the patient if they saw one reported value greater than 250 mg/L or less than 70 mg/dL, three values in the 181- to 250-mg/dL range within 1 month, or no texts back for 1 week.
"Ninety-one percent of the U.S. population already has a cell phone. So let’s use that as a way to circumvent these barriers to access to care," Ms. Garcia said. She and her associates are pursuing funding for further study of Dulce Digital with longer follow-up.
In a separate randomized, controlled French study of 190 adults with type 2 diabetes who were starting insulin, the Telediab2 software system loaded onto patients’ phones nearly doubled the likelihood that patients would achieve HbA1c levels of less than 7% by 13 months (31%), compared with patients in a control group or a third group who used a simplified software intervention for only the first 4 months (19%), Dr. Sylvia Franc reported in a poster presentation.
The TeleDiab2 system provides automatic basal insulin titration based on blood glucose targets and rules devised by the treating physician, as well as automatic personalized coaching for blood glucose monitoring, diet, and physical activity based on pre- and postprandial blood glucose values. The app enables remote telemonitoring and short teleconsultations, said Dr. Franc of Sud-Francilien Hospital, Corbeil Essones, France.
Physicians initiated and titrated basal insulin at baseline. Patients in the control group then received face-to-face consultations every 3 months. The simplified intervention group received phone consultations through the app for the first 4 months (and had significantly improved HbA1c levels, compared with the control group, in that period), then had face-to-face visits every 3 months. Patients in the Telediab2 group had no face-to-face visits; they had phone consultations every 2 weeks until month 4, then monthly phone consultations.
Mobile technology also impressed attendees at the meeting in four small studies showing progress in early attempts to develop an "artificial pancreas." In two 5-day crossover studies, 52 U.S. adults and adolescents with type 1 diabetes using a bionic insulin-glucagon pancreas achieved better glycemic control than did patients using insulin pump therapy (N. Engl. J. Med. 2014 June 15 [doi:10.1056/NEJMoa1314474]). The FlorenceD2 closed-loop insulin delivery system seemed to improve glucose control when used by patients at home in two small European randomized crossover studies.
Dr. Garcia and Dr. Franc reported having no financial disclosures. Lifescan, which sells glucose monitoring products, supported Dr. Garcia’s study.
On Twitter @SherryBoschert
Mobile app interventions for people with diabetes improved glycemic control in separate studies reported at the annual scientific sessions of the American Diabetes Association, San Francisco.
Interim results from a prospective randomized controlled study of 106 patients from a medically underserved Hispanic population with poorly controlled type 2 diabetes found that hemoglobin A1c (HbA1c) levels decreased by an average of a relative 12% after 6 months in those who used a text-messaging intervention called Dulce Digital on their mobile phones in addition to receiving usual care, compared with a 2% relative decrease in the control patients who received usual care alone.
Mean HbA1c levels decreased from 9.4% at baseline in the Dulce Digital group to 8.4% after 3 months and at 6 months. In the control group, mean HbA1c levels started at 9.5%, decreased to 9.2% at 3 months, and increased to 9.3% at 6 months. The differences between groups were statistically significant, nurse practitioner Maria Isabel Garcia reported.
Changes in other measures, including weight, blood pressure, or lipids, did not differ significantly between groups, said Ms. Garcia of Scripps Health, San Diego.
Patients in the Dulce Digital group who had no cell phone or had limited text-messaging service, received a phone with unlimited messaging. They then received two or three texts per day initially, with the frequency tapering over a 6-month period. Three kinds of texts were sent. Educational messages included a reminder to "Use small plates! Portions will look larger, and you may feel more satisfied after eating." Medication reminders might say, "Tick, tock. Take your medication at the same time every day!" Blood glucose prompts reminded patients, "Time to check your blood sugar! Text back your results."
Nurses monitored blood glucose responses and called the patient if they saw one reported value greater than 250 mg/L or less than 70 mg/dL, three values in the 181- to 250-mg/dL range within 1 month, or no texts back for 1 week.
"Ninety-one percent of the U.S. population already has a cell phone. So let’s use that as a way to circumvent these barriers to access to care," Ms. Garcia said. She and her associates are pursuing funding for further study of Dulce Digital with longer follow-up.
In a separate randomized, controlled French study of 190 adults with type 2 diabetes who were starting insulin, the Telediab2 software system loaded onto patients’ phones nearly doubled the likelihood that patients would achieve HbA1c levels of less than 7% by 13 months (31%), compared with patients in a control group or a third group who used a simplified software intervention for only the first 4 months (19%), Dr. Sylvia Franc reported in a poster presentation.
The TeleDiab2 system provides automatic basal insulin titration based on blood glucose targets and rules devised by the treating physician, as well as automatic personalized coaching for blood glucose monitoring, diet, and physical activity based on pre- and postprandial blood glucose values. The app enables remote telemonitoring and short teleconsultations, said Dr. Franc of Sud-Francilien Hospital, Corbeil Essones, France.
Physicians initiated and titrated basal insulin at baseline. Patients in the control group then received face-to-face consultations every 3 months. The simplified intervention group received phone consultations through the app for the first 4 months (and had significantly improved HbA1c levels, compared with the control group, in that period), then had face-to-face visits every 3 months. Patients in the Telediab2 group had no face-to-face visits; they had phone consultations every 2 weeks until month 4, then monthly phone consultations.
Mobile technology also impressed attendees at the meeting in four small studies showing progress in early attempts to develop an "artificial pancreas." In two 5-day crossover studies, 52 U.S. adults and adolescents with type 1 diabetes using a bionic insulin-glucagon pancreas achieved better glycemic control than did patients using insulin pump therapy (N. Engl. J. Med. 2014 June 15 [doi:10.1056/NEJMoa1314474]). The FlorenceD2 closed-loop insulin delivery system seemed to improve glucose control when used by patients at home in two small European randomized crossover studies.
Dr. Garcia and Dr. Franc reported having no financial disclosures. Lifescan, which sells glucose monitoring products, supported Dr. Garcia’s study.
On Twitter @SherryBoschert
Prescribing psychotropics to family members
Recently, I put up a post on our main Shrink Rap blog titled, "Is it okay to shrink your sister in an emergency?" Given how difficult it can be to get an appointment with a psychiatrist, I wondered about the ethics of prescribing psychotropics to a distressed family member when other options are limited.
First, I created a fictional scenario. Sister Lucy was treated for panic disorder 5 years ago. She took a benzodiazepine for a few weeks, an SSRI for a year, and went to psychotherapy. Her symptoms resolved, and she was able to terminate treatment with the blessing of her psychiatrist. Last year, Lucy moved to a new state and, being generally healthy, she has not yet established relationships with primary care providers. So with no physician, in a new state, Lucy had a recurrence of her panic disorder. She was initially seen in an emergency department, given a small supply of Ativan (lorazepam), and instructions to see a psychiatrist.
Lucy called around, and the earliest appointment she could get was 6 weeks away. She tried a handful of psychiatrists, but she did not call every psychiatrist in town. Most of the ones she tried were not taking new patients, and the voice mail systems of each mental health group were time consuming and frustrating, some cut her off, and no one had any more immediate response than to go to the ED if it were an emergency, and Lucy had already done that. Her brother, a psychiatrist in another state, came to visit for the weekend, and he witnessed several of her panic attacks. He had no more luck finding a psychiatrist for her. Lucy visited an urgent care center, where she was restarted on the SSRI and given more of the Ativan. But at the drugstore, she noticed she was given a 2-week supply and this would not last until the scheduled appointment.
So I asked our blog readers if it was okay for the brother to write prescriptions to hold his sister over until her scheduled appointment. The other options would have been for her to continue to suffer, to see if she could find another form of treatment more quickly, to return to the urgent care center on a continual basis and hope they would provide more medication, or to find a new primary care doctor who could prescribe in the meantime. Lucy didn’t know if this would be any easier. The psychiatrist who saw her 5 years ago before she moved would not be comfortable resuming medications without seeing her, but just in case there was any doubt, he retired, moved to North Korea, and died in a freak accident where he was swept up by a street cleaner so that option was not on the table (fictional characters can lead interesting and tragic lives).
Readers wrote in with a variety of thoughts. One psychiatrist empathized; she had a very depressed relative, and she debated providing medication samples in the interim while the relative waited to get in with a mental health professional. Another psychiatrist had seen too many patients become addicted to prescription benzodiazepines and suggested that this might start a cycle where Sister Lucy would pester brother psychiatrist for more medication in the future. Most of the psychiatrists felt that if a reasonable effort were made to obtain care and the barriers were valid, then it was a tough situation, but ultimately they felt it was okay to resume medications that previously had worked and been tolerated, for a limited period of time, since Lucy was symptomatic and this constituted an emergency.
The patients who wrote in were less forgiving, overall. Several insisted it was easy enough to find a primary care doctor within days, and a primary care doctor would certainly prescribe the medications. I was told that all one has to do is call one’s insurance company, so, curious, I called mine and got two names. The first one had a message saying staff was not in on Wednesday and the caller should try back tomorrow. I didn’t. The second one instructed me to leave a message that would be returned within 24 hours. It wasn’t. I e-mailed my own primary care doctor to ask when the next new patient appointment was – this physician charges a practice fee (too low to be considered "concierge," but high enough to enable a lower caseload). The response I received is that the practice is full. I e-mailed a friend who is a wonderful primary care doctor but takes no health insurance and has opted out of Medicare, and he had an opening the following week. I, however, had insider knowledge that a random newcomer to town might not have, and the insurance companies would certainly not be referring urgent cases to this out-of-network doctor. And all this assumes that any doc will do; there is no allowance here for the idea of waiting for a psychiatrist or internist who might come highly recommended or have subspecialty training.
I was left to say that it wasn’t easy to find a psychiatrist or a primary care doctor on demand when one is new in town and in a state of emotional distress. Again, I was told otherwise! I learned about a service called ZocDoc.com where you can make a next day appointment with a physician, simply by giving your Zip code, insurance, and specialty desired. Interesting, as I do this all the time with an App called OpenTable to schedule reservations at restaurants. Why not doctors’ appointments?
So it was late, and I tried to schedule a next day appointment with a primary care doc. It worked! Only I didn’t really want the appointment; what I wanted was information to write my article for Clinical Psychiatry News this week. I dialed the doctor to cancel the appointment, and instead of getting an office machine, I got the actual doctor – and he even sounded like a nice guy. He couldn’t cancel my appointment, but I then realized that, like OpenTable, there was a button to push to cancel the appointment, and I did that. I looked for psychiatrists, and there weren’t many with next day appointments – perhaps one – nearby, but if I would drive 30 miles or so to the next major city, I could get an appointment very soon, and certainly within a couple of weeks. Interesting. I learned something new!
So I wondered about Sister Lucy, and I decided she lives in Boise, Idaho, a place I’ve never been to and whose availability of medical care I know nothing about. The ZocDoc site there is not active, and so poor Lucy is back to her original problem, and I am left to the original question: Should her brother prescribe her medications?
Dr. Miller is a coauthor of "Shrink Rap: Three Psychiatrists Explain Their Work" (Baltimore: the Johns Hopkins University Press, 2011).
Recently, I put up a post on our main Shrink Rap blog titled, "Is it okay to shrink your sister in an emergency?" Given how difficult it can be to get an appointment with a psychiatrist, I wondered about the ethics of prescribing psychotropics to a distressed family member when other options are limited.
First, I created a fictional scenario. Sister Lucy was treated for panic disorder 5 years ago. She took a benzodiazepine for a few weeks, an SSRI for a year, and went to psychotherapy. Her symptoms resolved, and she was able to terminate treatment with the blessing of her psychiatrist. Last year, Lucy moved to a new state and, being generally healthy, she has not yet established relationships with primary care providers. So with no physician, in a new state, Lucy had a recurrence of her panic disorder. She was initially seen in an emergency department, given a small supply of Ativan (lorazepam), and instructions to see a psychiatrist.
Lucy called around, and the earliest appointment she could get was 6 weeks away. She tried a handful of psychiatrists, but she did not call every psychiatrist in town. Most of the ones she tried were not taking new patients, and the voice mail systems of each mental health group were time consuming and frustrating, some cut her off, and no one had any more immediate response than to go to the ED if it were an emergency, and Lucy had already done that. Her brother, a psychiatrist in another state, came to visit for the weekend, and he witnessed several of her panic attacks. He had no more luck finding a psychiatrist for her. Lucy visited an urgent care center, where she was restarted on the SSRI and given more of the Ativan. But at the drugstore, she noticed she was given a 2-week supply and this would not last until the scheduled appointment.
So I asked our blog readers if it was okay for the brother to write prescriptions to hold his sister over until her scheduled appointment. The other options would have been for her to continue to suffer, to see if she could find another form of treatment more quickly, to return to the urgent care center on a continual basis and hope they would provide more medication, or to find a new primary care doctor who could prescribe in the meantime. Lucy didn’t know if this would be any easier. The psychiatrist who saw her 5 years ago before she moved would not be comfortable resuming medications without seeing her, but just in case there was any doubt, he retired, moved to North Korea, and died in a freak accident where he was swept up by a street cleaner so that option was not on the table (fictional characters can lead interesting and tragic lives).
Readers wrote in with a variety of thoughts. One psychiatrist empathized; she had a very depressed relative, and she debated providing medication samples in the interim while the relative waited to get in with a mental health professional. Another psychiatrist had seen too many patients become addicted to prescription benzodiazepines and suggested that this might start a cycle where Sister Lucy would pester brother psychiatrist for more medication in the future. Most of the psychiatrists felt that if a reasonable effort were made to obtain care and the barriers were valid, then it was a tough situation, but ultimately they felt it was okay to resume medications that previously had worked and been tolerated, for a limited period of time, since Lucy was symptomatic and this constituted an emergency.
The patients who wrote in were less forgiving, overall. Several insisted it was easy enough to find a primary care doctor within days, and a primary care doctor would certainly prescribe the medications. I was told that all one has to do is call one’s insurance company, so, curious, I called mine and got two names. The first one had a message saying staff was not in on Wednesday and the caller should try back tomorrow. I didn’t. The second one instructed me to leave a message that would be returned within 24 hours. It wasn’t. I e-mailed my own primary care doctor to ask when the next new patient appointment was – this physician charges a practice fee (too low to be considered "concierge," but high enough to enable a lower caseload). The response I received is that the practice is full. I e-mailed a friend who is a wonderful primary care doctor but takes no health insurance and has opted out of Medicare, and he had an opening the following week. I, however, had insider knowledge that a random newcomer to town might not have, and the insurance companies would certainly not be referring urgent cases to this out-of-network doctor. And all this assumes that any doc will do; there is no allowance here for the idea of waiting for a psychiatrist or internist who might come highly recommended or have subspecialty training.
I was left to say that it wasn’t easy to find a psychiatrist or a primary care doctor on demand when one is new in town and in a state of emotional distress. Again, I was told otherwise! I learned about a service called ZocDoc.com where you can make a next day appointment with a physician, simply by giving your Zip code, insurance, and specialty desired. Interesting, as I do this all the time with an App called OpenTable to schedule reservations at restaurants. Why not doctors’ appointments?
So it was late, and I tried to schedule a next day appointment with a primary care doc. It worked! Only I didn’t really want the appointment; what I wanted was information to write my article for Clinical Psychiatry News this week. I dialed the doctor to cancel the appointment, and instead of getting an office machine, I got the actual doctor – and he even sounded like a nice guy. He couldn’t cancel my appointment, but I then realized that, like OpenTable, there was a button to push to cancel the appointment, and I did that. I looked for psychiatrists, and there weren’t many with next day appointments – perhaps one – nearby, but if I would drive 30 miles or so to the next major city, I could get an appointment very soon, and certainly within a couple of weeks. Interesting. I learned something new!
So I wondered about Sister Lucy, and I decided she lives in Boise, Idaho, a place I’ve never been to and whose availability of medical care I know nothing about. The ZocDoc site there is not active, and so poor Lucy is back to her original problem, and I am left to the original question: Should her brother prescribe her medications?
Dr. Miller is a coauthor of "Shrink Rap: Three Psychiatrists Explain Their Work" (Baltimore: the Johns Hopkins University Press, 2011).
Recently, I put up a post on our main Shrink Rap blog titled, "Is it okay to shrink your sister in an emergency?" Given how difficult it can be to get an appointment with a psychiatrist, I wondered about the ethics of prescribing psychotropics to a distressed family member when other options are limited.
First, I created a fictional scenario. Sister Lucy was treated for panic disorder 5 years ago. She took a benzodiazepine for a few weeks, an SSRI for a year, and went to psychotherapy. Her symptoms resolved, and she was able to terminate treatment with the blessing of her psychiatrist. Last year, Lucy moved to a new state and, being generally healthy, she has not yet established relationships with primary care providers. So with no physician, in a new state, Lucy had a recurrence of her panic disorder. She was initially seen in an emergency department, given a small supply of Ativan (lorazepam), and instructions to see a psychiatrist.
Lucy called around, and the earliest appointment she could get was 6 weeks away. She tried a handful of psychiatrists, but she did not call every psychiatrist in town. Most of the ones she tried were not taking new patients, and the voice mail systems of each mental health group were time consuming and frustrating, some cut her off, and no one had any more immediate response than to go to the ED if it were an emergency, and Lucy had already done that. Her brother, a psychiatrist in another state, came to visit for the weekend, and he witnessed several of her panic attacks. He had no more luck finding a psychiatrist for her. Lucy visited an urgent care center, where she was restarted on the SSRI and given more of the Ativan. But at the drugstore, she noticed she was given a 2-week supply and this would not last until the scheduled appointment.
So I asked our blog readers if it was okay for the brother to write prescriptions to hold his sister over until her scheduled appointment. The other options would have been for her to continue to suffer, to see if she could find another form of treatment more quickly, to return to the urgent care center on a continual basis and hope they would provide more medication, or to find a new primary care doctor who could prescribe in the meantime. Lucy didn’t know if this would be any easier. The psychiatrist who saw her 5 years ago before she moved would not be comfortable resuming medications without seeing her, but just in case there was any doubt, he retired, moved to North Korea, and died in a freak accident where he was swept up by a street cleaner so that option was not on the table (fictional characters can lead interesting and tragic lives).
Readers wrote in with a variety of thoughts. One psychiatrist empathized; she had a very depressed relative, and she debated providing medication samples in the interim while the relative waited to get in with a mental health professional. Another psychiatrist had seen too many patients become addicted to prescription benzodiazepines and suggested that this might start a cycle where Sister Lucy would pester brother psychiatrist for more medication in the future. Most of the psychiatrists felt that if a reasonable effort were made to obtain care and the barriers were valid, then it was a tough situation, but ultimately they felt it was okay to resume medications that previously had worked and been tolerated, for a limited period of time, since Lucy was symptomatic and this constituted an emergency.
The patients who wrote in were less forgiving, overall. Several insisted it was easy enough to find a primary care doctor within days, and a primary care doctor would certainly prescribe the medications. I was told that all one has to do is call one’s insurance company, so, curious, I called mine and got two names. The first one had a message saying staff was not in on Wednesday and the caller should try back tomorrow. I didn’t. The second one instructed me to leave a message that would be returned within 24 hours. It wasn’t. I e-mailed my own primary care doctor to ask when the next new patient appointment was – this physician charges a practice fee (too low to be considered "concierge," but high enough to enable a lower caseload). The response I received is that the practice is full. I e-mailed a friend who is a wonderful primary care doctor but takes no health insurance and has opted out of Medicare, and he had an opening the following week. I, however, had insider knowledge that a random newcomer to town might not have, and the insurance companies would certainly not be referring urgent cases to this out-of-network doctor. And all this assumes that any doc will do; there is no allowance here for the idea of waiting for a psychiatrist or internist who might come highly recommended or have subspecialty training.
I was left to say that it wasn’t easy to find a psychiatrist or a primary care doctor on demand when one is new in town and in a state of emotional distress. Again, I was told otherwise! I learned about a service called ZocDoc.com where you can make a next day appointment with a physician, simply by giving your Zip code, insurance, and specialty desired. Interesting, as I do this all the time with an App called OpenTable to schedule reservations at restaurants. Why not doctors’ appointments?
So it was late, and I tried to schedule a next day appointment with a primary care doc. It worked! Only I didn’t really want the appointment; what I wanted was information to write my article for Clinical Psychiatry News this week. I dialed the doctor to cancel the appointment, and instead of getting an office machine, I got the actual doctor – and he even sounded like a nice guy. He couldn’t cancel my appointment, but I then realized that, like OpenTable, there was a button to push to cancel the appointment, and I did that. I looked for psychiatrists, and there weren’t many with next day appointments – perhaps one – nearby, but if I would drive 30 miles or so to the next major city, I could get an appointment very soon, and certainly within a couple of weeks. Interesting. I learned something new!
So I wondered about Sister Lucy, and I decided she lives in Boise, Idaho, a place I’ve never been to and whose availability of medical care I know nothing about. The ZocDoc site there is not active, and so poor Lucy is back to her original problem, and I am left to the original question: Should her brother prescribe her medications?
Dr. Miller is a coauthor of "Shrink Rap: Three Psychiatrists Explain Their Work" (Baltimore: the Johns Hopkins University Press, 2011).
Bariatric surgery/Preventive medicine
Until recently, bariatric surgery was considered a cosmetic operation with little physiologic importance. A series of preliminary randomized clinical trials, however, have suggested that bariatric surgery may have importance in mitigating the adverse pathophysiology associated with obesity, including type 2 diabetes and some cardiovascular risk factors.
The finding of a surgical method of modifying this disease, which has occupied research for the last century, is somewhat unexpected after the many false starts associated with medical interventions. The two most popular surgical procedures, the gastric bypass and the sleeve gastrectomy performed using laparoscopic techniques, are currently being performed in obese patients with BMIs of greater than 35 with very low morbidly and rare mortality events. Several nonrandomized and prospective trials have examined the effect of bariatric surgery and reported beneficial effects on diabetes regression and significant reduction in major cardiovascular disease ( JAMA 2012;307:56-65).
The recent report of the 3-year follow-up of the STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial ( N. Engl. J. Med. 2014;370:2002-13) provides additional physiologic information on the benefits of bariatric surgery in 150 obese diabetic patients aged 20-60 years with BMIs of 27-43, compared with intensive medical therapy. Patients were randomized to three arms: intensive medical therapy, gastric bypass, or sleeve gastrectomy. Most of the patients were white women with a history of diabetes for 8.3 years; the mean hemoglobin A1c was 9.3%. At baseline, 43% of the patients required insulin therapy. The primary endpoint was the achievement of HbA1c of 6% or less, which was achieved in 5% of the medically treated patients, compared with 38% in the gastric bypass group and 24% in the sleeve gastrectomy group. Decrease in BMI was the only measure that predicted the achievement of the HbA1c endpoint. Body weight decreased by 4.5% in the intensive medical group, 24.5% in the gastric bypass group, and 21.1% in the sleeve gastrectomy group. Significant decreases in low-density lipoprotein cholesterol and increases in high-density lipoprotein cholesterol were achieved in both surgical intervention groups, compared with the intensive medical care group. In addition, medical control of diabetes was improved and 69% and 43% of the gastrectomy and sleeve bypass group, respectively, were no longer requiring insulin therapy. There was, however, no significant difference in the change in blood pressure in the three groups. There were no life-threatening complications or deaths in the groups, but there were a number of complications associated with the procedure.
The metabolic changes associated with bariatric surgery reported in STAMPEDE open the door for future randomized studies examining long-term morbidity and mortality benefits that may be attributed to this therapy. Bariatric surgery is being performed widely in the United States with very low mortality and morbidity. Previous short-term studies have reported the benefit of bariatric surgery, compared with intensive medical therapy. The longer duration of follow-up in STAMPEDE emphasizes the need for larger randomized trials of this method of therapy. The study of the surgical patients may also provide new insight into the relationship of body fat to the expression of type 2 diabetes.
The prevention of medical disease using surgical techniques in clinical medicine has not been a particularly fertile road of investigation. Intervention in the treatment of coronary artery disease with bypass surgery although associated with symptomatic benefit and with some exceptions, has not been overwhelmingly successful in affecting the long-term mortality of that disease. Bariatric surgery may be the first surgical intervention that can arrest or even reverse type 2 diabetes and its many sequelae.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Until recently, bariatric surgery was considered a cosmetic operation with little physiologic importance. A series of preliminary randomized clinical trials, however, have suggested that bariatric surgery may have importance in mitigating the adverse pathophysiology associated with obesity, including type 2 diabetes and some cardiovascular risk factors.
The finding of a surgical method of modifying this disease, which has occupied research for the last century, is somewhat unexpected after the many false starts associated with medical interventions. The two most popular surgical procedures, the gastric bypass and the sleeve gastrectomy performed using laparoscopic techniques, are currently being performed in obese patients with BMIs of greater than 35 with very low morbidly and rare mortality events. Several nonrandomized and prospective trials have examined the effect of bariatric surgery and reported beneficial effects on diabetes regression and significant reduction in major cardiovascular disease ( JAMA 2012;307:56-65).
The recent report of the 3-year follow-up of the STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial ( N. Engl. J. Med. 2014;370:2002-13) provides additional physiologic information on the benefits of bariatric surgery in 150 obese diabetic patients aged 20-60 years with BMIs of 27-43, compared with intensive medical therapy. Patients were randomized to three arms: intensive medical therapy, gastric bypass, or sleeve gastrectomy. Most of the patients were white women with a history of diabetes for 8.3 years; the mean hemoglobin A1c was 9.3%. At baseline, 43% of the patients required insulin therapy. The primary endpoint was the achievement of HbA1c of 6% or less, which was achieved in 5% of the medically treated patients, compared with 38% in the gastric bypass group and 24% in the sleeve gastrectomy group. Decrease in BMI was the only measure that predicted the achievement of the HbA1c endpoint. Body weight decreased by 4.5% in the intensive medical group, 24.5% in the gastric bypass group, and 21.1% in the sleeve gastrectomy group. Significant decreases in low-density lipoprotein cholesterol and increases in high-density lipoprotein cholesterol were achieved in both surgical intervention groups, compared with the intensive medical care group. In addition, medical control of diabetes was improved and 69% and 43% of the gastrectomy and sleeve bypass group, respectively, were no longer requiring insulin therapy. There was, however, no significant difference in the change in blood pressure in the three groups. There were no life-threatening complications or deaths in the groups, but there were a number of complications associated with the procedure.
The metabolic changes associated with bariatric surgery reported in STAMPEDE open the door for future randomized studies examining long-term morbidity and mortality benefits that may be attributed to this therapy. Bariatric surgery is being performed widely in the United States with very low mortality and morbidity. Previous short-term studies have reported the benefit of bariatric surgery, compared with intensive medical therapy. The longer duration of follow-up in STAMPEDE emphasizes the need for larger randomized trials of this method of therapy. The study of the surgical patients may also provide new insight into the relationship of body fat to the expression of type 2 diabetes.
The prevention of medical disease using surgical techniques in clinical medicine has not been a particularly fertile road of investigation. Intervention in the treatment of coronary artery disease with bypass surgery although associated with symptomatic benefit and with some exceptions, has not been overwhelmingly successful in affecting the long-term mortality of that disease. Bariatric surgery may be the first surgical intervention that can arrest or even reverse type 2 diabetes and its many sequelae.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Until recently, bariatric surgery was considered a cosmetic operation with little physiologic importance. A series of preliminary randomized clinical trials, however, have suggested that bariatric surgery may have importance in mitigating the adverse pathophysiology associated with obesity, including type 2 diabetes and some cardiovascular risk factors.
The finding of a surgical method of modifying this disease, which has occupied research for the last century, is somewhat unexpected after the many false starts associated with medical interventions. The two most popular surgical procedures, the gastric bypass and the sleeve gastrectomy performed using laparoscopic techniques, are currently being performed in obese patients with BMIs of greater than 35 with very low morbidly and rare mortality events. Several nonrandomized and prospective trials have examined the effect of bariatric surgery and reported beneficial effects on diabetes regression and significant reduction in major cardiovascular disease ( JAMA 2012;307:56-65).
The recent report of the 3-year follow-up of the STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial ( N. Engl. J. Med. 2014;370:2002-13) provides additional physiologic information on the benefits of bariatric surgery in 150 obese diabetic patients aged 20-60 years with BMIs of 27-43, compared with intensive medical therapy. Patients were randomized to three arms: intensive medical therapy, gastric bypass, or sleeve gastrectomy. Most of the patients were white women with a history of diabetes for 8.3 years; the mean hemoglobin A1c was 9.3%. At baseline, 43% of the patients required insulin therapy. The primary endpoint was the achievement of HbA1c of 6% or less, which was achieved in 5% of the medically treated patients, compared with 38% in the gastric bypass group and 24% in the sleeve gastrectomy group. Decrease in BMI was the only measure that predicted the achievement of the HbA1c endpoint. Body weight decreased by 4.5% in the intensive medical group, 24.5% in the gastric bypass group, and 21.1% in the sleeve gastrectomy group. Significant decreases in low-density lipoprotein cholesterol and increases in high-density lipoprotein cholesterol were achieved in both surgical intervention groups, compared with the intensive medical care group. In addition, medical control of diabetes was improved and 69% and 43% of the gastrectomy and sleeve bypass group, respectively, were no longer requiring insulin therapy. There was, however, no significant difference in the change in blood pressure in the three groups. There were no life-threatening complications or deaths in the groups, but there were a number of complications associated with the procedure.
The metabolic changes associated with bariatric surgery reported in STAMPEDE open the door for future randomized studies examining long-term morbidity and mortality benefits that may be attributed to this therapy. Bariatric surgery is being performed widely in the United States with very low mortality and morbidity. Previous short-term studies have reported the benefit of bariatric surgery, compared with intensive medical therapy. The longer duration of follow-up in STAMPEDE emphasizes the need for larger randomized trials of this method of therapy. The study of the surgical patients may also provide new insight into the relationship of body fat to the expression of type 2 diabetes.
The prevention of medical disease using surgical techniques in clinical medicine has not been a particularly fertile road of investigation. Intervention in the treatment of coronary artery disease with bypass surgery although associated with symptomatic benefit and with some exceptions, has not been overwhelmingly successful in affecting the long-term mortality of that disease. Bariatric surgery may be the first surgical intervention that can arrest or even reverse type 2 diabetes and its many sequelae.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Keeping Safe in the Water
Summer is here, and with it comes an increase in swimming and other aquatic activities. To me, there is nothing more relaxing than floating in the ocean or a pool. (Personally, I’ve never been a lake girl.)
I cannot remember not knowing how to swim. My mother, who in her youth was a swimming instructor, taught all my siblings and me. Mom instructed us not only on how to swim but also on understanding that every “body” of water has the potential to be dangerous.
Moreover, we all knew “the rules” to follow when near the water. The key ones: Pay attention in the water; wait an hour after eating before going in; and never swim alone. If we were in a boat, regardless of our swimming ability, we were required to wear a life jacket. Failure to adhere to even one of these would result in being “dry docked”—in other words, having to sit on the beach or poolside and not being allowed to go into the water. This was something none of us ever wanted.
Because of my childhood experience, swimming and water safety are second nature to me, along with playing a role in water safety activities through high school and college. I was a lifeguard at local pools and taught swimming and lifesaving at a YMCA. Just as I learned, I taught others to be ever vigilant around the water. I was, and taught others to be, cautious about never swimming alone—always have a buddy—and when in the ocean, to heed the warning signs of dangerous waves or riptides.
I taught people of all ages to swim. The youngest was an 8-month-old girl and the oldest, a 62-year-old man. While I never expected either of them to become a competitive swimmer, what I wanted was for them to be able to keep safe around the water. That is the goal of teaching someone to swim: to give that person the tools to save himself or herself when in danger in the water. Sadly, every season (not just summer), people drown.
According to the CDC’s National Center for Injury Prevention and Control, the leading factors that affect the risk for drowning—the ones over which we have control—are
Lack of Swimming Ability: Many people—adults and children alike—report that they cannot swim. Research indicates that formal swimming lessons can reduce the risk for drowning among children ages 1 to 4.
Lack of Barriers: Barriers such as fencing can prevent young children from gaining access to a pool without caregivers’ awareness. (Some municipalities have zoning ordinances for private pool owners, requiring barriers for safety.)
Lack of Supervision: Drowning can happen quickly and quietly anywhere there is water (eg, bathtub, swimming pool, bucket) and even in the presence of lifeguards.
Location: People of different ages drown in different locations. For example, home swimming pools are the site of most drownings among children ages 1 to 4. Drownings in natural settings (eg, lakes, rivers, oceans) increase with age; more than half of fatal and nonfatal drownings among those ages 15 and older occur in these settings.
Failure to Wear Life Jackets: The US Coast Guard (USCG) received reports of 4,604 boating incidents in 2010; a total of 3,153 boaters were injured, and 672 died. Most boating deaths were by drowning, with 88% of victims not wearing life jackets at the time of the incident.
Alcohol Use: Among adolescents and adults, alcohol use is involved in up to 70% of deaths associated with water recreation, almost a quarter of emergency department visits for drowning, and about one in five reported boating deaths.1
Since 2010, I have read multiple news stories about people drowning unintentionally. The causes have ranged from being swept away in raging floodwaters; grounding, capsizing, or sinking a vessel; and water-skiing or similar mishaps.2 In fact, each day about 10 people die from unintentional drowning; what is surprising is that only two of them are children younger than 14. This statistic tells me that we need to include water safety warnings in our “anticipatory guidance” for all patients. We must raise awareness of the need to be cautious around water, even if the person knows how to swim.
The National Drowning Prevention Alliance, the USCG, the CDC, and the World Health Organization provide information about water safety and drowning prevention. The vital message is that no single device or solution can prevent drowning.
That said, we must remind our patients and families to be attentive while near, in, or on the water. Caution them to be alert to potential dangers in all environments—even the most innocent-looking or most familiar body of water can be a threat. All adults and children should wear life jackets or personal flotation devices (PFD) approved by the USCG when boating (even if the boat is only a canoe)!
Recent events among my circle of friends and family have made me revisit one of the rules of my childhood and consider extending it. In discussions with colleagues, I have suggested that we recommend everyone older than 40 seriously consider wearing some type of PFD when near or in the water, even if they are not in a boat. Some rebuffed this idea as an unnecessary nuisance. But I consider it a minor inconvenience that could mean the difference between a fatal and nonfatal aquatic incident. I cannot help but wonder if it would have made a difference in some cases.
How strictly do you enforce “the rules” for yourself and your family? Share your feedback at [email protected].
REFERENCES
1. CDC. Unintentional drowning: get the facts. www.cdc.gov/HomeandRecreationalSafety/Water-Safety/waterinjuries-factsheet.html. Accessed June 16, 2014.
2. US Department of Homeland Security and US Coast Guard. 2013 Recreational Boating Statistics. COMDTPUB P16754.27. www.uscgboating.org/assets/1/AssetManager/2013RecBoatingStats.pdf. Accessed June 16, 2014.
Summer is here, and with it comes an increase in swimming and other aquatic activities. To me, there is nothing more relaxing than floating in the ocean or a pool. (Personally, I’ve never been a lake girl.)
I cannot remember not knowing how to swim. My mother, who in her youth was a swimming instructor, taught all my siblings and me. Mom instructed us not only on how to swim but also on understanding that every “body” of water has the potential to be dangerous.
Moreover, we all knew “the rules” to follow when near the water. The key ones: Pay attention in the water; wait an hour after eating before going in; and never swim alone. If we were in a boat, regardless of our swimming ability, we were required to wear a life jacket. Failure to adhere to even one of these would result in being “dry docked”—in other words, having to sit on the beach or poolside and not being allowed to go into the water. This was something none of us ever wanted.
Because of my childhood experience, swimming and water safety are second nature to me, along with playing a role in water safety activities through high school and college. I was a lifeguard at local pools and taught swimming and lifesaving at a YMCA. Just as I learned, I taught others to be ever vigilant around the water. I was, and taught others to be, cautious about never swimming alone—always have a buddy—and when in the ocean, to heed the warning signs of dangerous waves or riptides.
I taught people of all ages to swim. The youngest was an 8-month-old girl and the oldest, a 62-year-old man. While I never expected either of them to become a competitive swimmer, what I wanted was for them to be able to keep safe around the water. That is the goal of teaching someone to swim: to give that person the tools to save himself or herself when in danger in the water. Sadly, every season (not just summer), people drown.
According to the CDC’s National Center for Injury Prevention and Control, the leading factors that affect the risk for drowning—the ones over which we have control—are
Lack of Swimming Ability: Many people—adults and children alike—report that they cannot swim. Research indicates that formal swimming lessons can reduce the risk for drowning among children ages 1 to 4.
Lack of Barriers: Barriers such as fencing can prevent young children from gaining access to a pool without caregivers’ awareness. (Some municipalities have zoning ordinances for private pool owners, requiring barriers for safety.)
Lack of Supervision: Drowning can happen quickly and quietly anywhere there is water (eg, bathtub, swimming pool, bucket) and even in the presence of lifeguards.
Location: People of different ages drown in different locations. For example, home swimming pools are the site of most drownings among children ages 1 to 4. Drownings in natural settings (eg, lakes, rivers, oceans) increase with age; more than half of fatal and nonfatal drownings among those ages 15 and older occur in these settings.
Failure to Wear Life Jackets: The US Coast Guard (USCG) received reports of 4,604 boating incidents in 2010; a total of 3,153 boaters were injured, and 672 died. Most boating deaths were by drowning, with 88% of victims not wearing life jackets at the time of the incident.
Alcohol Use: Among adolescents and adults, alcohol use is involved in up to 70% of deaths associated with water recreation, almost a quarter of emergency department visits for drowning, and about one in five reported boating deaths.1
Since 2010, I have read multiple news stories about people drowning unintentionally. The causes have ranged from being swept away in raging floodwaters; grounding, capsizing, or sinking a vessel; and water-skiing or similar mishaps.2 In fact, each day about 10 people die from unintentional drowning; what is surprising is that only two of them are children younger than 14. This statistic tells me that we need to include water safety warnings in our “anticipatory guidance” for all patients. We must raise awareness of the need to be cautious around water, even if the person knows how to swim.
The National Drowning Prevention Alliance, the USCG, the CDC, and the World Health Organization provide information about water safety and drowning prevention. The vital message is that no single device or solution can prevent drowning.
That said, we must remind our patients and families to be attentive while near, in, or on the water. Caution them to be alert to potential dangers in all environments—even the most innocent-looking or most familiar body of water can be a threat. All adults and children should wear life jackets or personal flotation devices (PFD) approved by the USCG when boating (even if the boat is only a canoe)!
Recent events among my circle of friends and family have made me revisit one of the rules of my childhood and consider extending it. In discussions with colleagues, I have suggested that we recommend everyone older than 40 seriously consider wearing some type of PFD when near or in the water, even if they are not in a boat. Some rebuffed this idea as an unnecessary nuisance. But I consider it a minor inconvenience that could mean the difference between a fatal and nonfatal aquatic incident. I cannot help but wonder if it would have made a difference in some cases.
How strictly do you enforce “the rules” for yourself and your family? Share your feedback at [email protected].
REFERENCES
1. CDC. Unintentional drowning: get the facts. www.cdc.gov/HomeandRecreationalSafety/Water-Safety/waterinjuries-factsheet.html. Accessed June 16, 2014.
2. US Department of Homeland Security and US Coast Guard. 2013 Recreational Boating Statistics. COMDTPUB P16754.27. www.uscgboating.org/assets/1/AssetManager/2013RecBoatingStats.pdf. Accessed June 16, 2014.
Summer is here, and with it comes an increase in swimming and other aquatic activities. To me, there is nothing more relaxing than floating in the ocean or a pool. (Personally, I’ve never been a lake girl.)
I cannot remember not knowing how to swim. My mother, who in her youth was a swimming instructor, taught all my siblings and me. Mom instructed us not only on how to swim but also on understanding that every “body” of water has the potential to be dangerous.
Moreover, we all knew “the rules” to follow when near the water. The key ones: Pay attention in the water; wait an hour after eating before going in; and never swim alone. If we were in a boat, regardless of our swimming ability, we were required to wear a life jacket. Failure to adhere to even one of these would result in being “dry docked”—in other words, having to sit on the beach or poolside and not being allowed to go into the water. This was something none of us ever wanted.
Because of my childhood experience, swimming and water safety are second nature to me, along with playing a role in water safety activities through high school and college. I was a lifeguard at local pools and taught swimming and lifesaving at a YMCA. Just as I learned, I taught others to be ever vigilant around the water. I was, and taught others to be, cautious about never swimming alone—always have a buddy—and when in the ocean, to heed the warning signs of dangerous waves or riptides.
I taught people of all ages to swim. The youngest was an 8-month-old girl and the oldest, a 62-year-old man. While I never expected either of them to become a competitive swimmer, what I wanted was for them to be able to keep safe around the water. That is the goal of teaching someone to swim: to give that person the tools to save himself or herself when in danger in the water. Sadly, every season (not just summer), people drown.
According to the CDC’s National Center for Injury Prevention and Control, the leading factors that affect the risk for drowning—the ones over which we have control—are
Lack of Swimming Ability: Many people—adults and children alike—report that they cannot swim. Research indicates that formal swimming lessons can reduce the risk for drowning among children ages 1 to 4.
Lack of Barriers: Barriers such as fencing can prevent young children from gaining access to a pool without caregivers’ awareness. (Some municipalities have zoning ordinances for private pool owners, requiring barriers for safety.)
Lack of Supervision: Drowning can happen quickly and quietly anywhere there is water (eg, bathtub, swimming pool, bucket) and even in the presence of lifeguards.
Location: People of different ages drown in different locations. For example, home swimming pools are the site of most drownings among children ages 1 to 4. Drownings in natural settings (eg, lakes, rivers, oceans) increase with age; more than half of fatal and nonfatal drownings among those ages 15 and older occur in these settings.
Failure to Wear Life Jackets: The US Coast Guard (USCG) received reports of 4,604 boating incidents in 2010; a total of 3,153 boaters were injured, and 672 died. Most boating deaths were by drowning, with 88% of victims not wearing life jackets at the time of the incident.
Alcohol Use: Among adolescents and adults, alcohol use is involved in up to 70% of deaths associated with water recreation, almost a quarter of emergency department visits for drowning, and about one in five reported boating deaths.1
Since 2010, I have read multiple news stories about people drowning unintentionally. The causes have ranged from being swept away in raging floodwaters; grounding, capsizing, or sinking a vessel; and water-skiing or similar mishaps.2 In fact, each day about 10 people die from unintentional drowning; what is surprising is that only two of them are children younger than 14. This statistic tells me that we need to include water safety warnings in our “anticipatory guidance” for all patients. We must raise awareness of the need to be cautious around water, even if the person knows how to swim.
The National Drowning Prevention Alliance, the USCG, the CDC, and the World Health Organization provide information about water safety and drowning prevention. The vital message is that no single device or solution can prevent drowning.
That said, we must remind our patients and families to be attentive while near, in, or on the water. Caution them to be alert to potential dangers in all environments—even the most innocent-looking or most familiar body of water can be a threat. All adults and children should wear life jackets or personal flotation devices (PFD) approved by the USCG when boating (even if the boat is only a canoe)!
Recent events among my circle of friends and family have made me revisit one of the rules of my childhood and consider extending it. In discussions with colleagues, I have suggested that we recommend everyone older than 40 seriously consider wearing some type of PFD when near or in the water, even if they are not in a boat. Some rebuffed this idea as an unnecessary nuisance. But I consider it a minor inconvenience that could mean the difference between a fatal and nonfatal aquatic incident. I cannot help but wonder if it would have made a difference in some cases.
How strictly do you enforce “the rules” for yourself and your family? Share your feedback at [email protected].
REFERENCES
1. CDC. Unintentional drowning: get the facts. www.cdc.gov/HomeandRecreationalSafety/Water-Safety/waterinjuries-factsheet.html. Accessed June 16, 2014.
2. US Department of Homeland Security and US Coast Guard. 2013 Recreational Boating Statistics. COMDTPUB P16754.27. www.uscgboating.org/assets/1/AssetManager/2013RecBoatingStats.pdf. Accessed June 16, 2014.