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Study eyes liability associated with implantable devices for chronic pain
SAN DIEGO – The maintenance of implantable drug delivery systems for the management of chronic pain was associated with death, permanent brain damage, or permanent neurological injury from granuloma, and was largely associated with substandard care.
Those are key findings from an analysis of data from the Anesthesia Closed Claims Project that were presented by Dr. Dermot R. Fitzgibbon at the annual meeting of the American Society of Anesthesiologists.
“Implantable devices are relatively new in chronic pain management, and have only been available since the early 1990s,” said Dr. Fitzgibbon, professor of anesthesiology and pain medicine at the University of Washington, Seattle. Such devices are considered advanced techniques for refractory chronic pain and include implantable drug delivery systems, spinal cord stimulators, and peripheral nerve stimulators. Previous studies have demonstrated that morbidity and mortality from implantable drug delivery systems (IDDS) and spinal cord stimulators typically occur during implantation or removal of devices or during device maintenance (Neuromodulation. 2012;15[5]:467-82 and Clin J Pain. 2007;23[2]:180-95). The purpose of the current study was to investigate liability associated with implantable devices used to manage chronic pain.
Dr. Fitzgibbon and his associates used the Anesthesia Closed Claims Project Database to identify 970 claims related to chronic pain that have occurred since 1990. A total of 148 of these claims were related to implantable devices, and the majority of them were for surgical procedures (107 [72%] vs. 41 [28%] for IDDS maintenance).
Of the 107 surgical device procedures, 50% were for an IDDS system, followed by spinal cord stimulator (40%), tunneled epidural (7%), and peripheral nerve stimulator (3%). Temporary minor injury occurred in 74% of the surgical device procedures, followed by permanent cord injury (16%), death/permanent brain damage (8%), and other permanent injury (2%). The most common reasons for permanent spinal cord injury were needle or catheter trauma to the cord (7 cases), epidural hematoma (3 cases), and incorrect placement of the stimulator (2 cases). Infections occurred in 25 of the surgical device procedures. Among these 25 claims, 3 resulted in death or severe permanent injury, 7 involved retained parts and sponges, and 5 were cases of epidural abscess – 4 of which were associated with a tunneled epidural catheter.
Of the 41 damaging events that occurred during IDDS maintenance, 44% were temporary minor injuries, while 32% involved death or permanent brain damage from medication administration errors and 24% involved permanent spinal cord injury, primarily from a delay in recognition of granuloma formation at the catheter tip.
The researchers found that maintenance of IDDS, compared with claims related to other surgical devices, were more commonly associated with a risk of death or permanent damage, less commonly resulted in temporary minor injury, were more likely to have care deemed as substandard, and were more commonly associated with payments (P = .001 for all comparisons). The median payment for all claims was $274,000.
The Anesthesia Closed Claims Project is funded by the Anesthesia Quality Institute. Dr. Fitzgibbon reported having no financial disclosures.
SAN DIEGO – The maintenance of implantable drug delivery systems for the management of chronic pain was associated with death, permanent brain damage, or permanent neurological injury from granuloma, and was largely associated with substandard care.
Those are key findings from an analysis of data from the Anesthesia Closed Claims Project that were presented by Dr. Dermot R. Fitzgibbon at the annual meeting of the American Society of Anesthesiologists.
“Implantable devices are relatively new in chronic pain management, and have only been available since the early 1990s,” said Dr. Fitzgibbon, professor of anesthesiology and pain medicine at the University of Washington, Seattle. Such devices are considered advanced techniques for refractory chronic pain and include implantable drug delivery systems, spinal cord stimulators, and peripheral nerve stimulators. Previous studies have demonstrated that morbidity and mortality from implantable drug delivery systems (IDDS) and spinal cord stimulators typically occur during implantation or removal of devices or during device maintenance (Neuromodulation. 2012;15[5]:467-82 and Clin J Pain. 2007;23[2]:180-95). The purpose of the current study was to investigate liability associated with implantable devices used to manage chronic pain.
Dr. Fitzgibbon and his associates used the Anesthesia Closed Claims Project Database to identify 970 claims related to chronic pain that have occurred since 1990. A total of 148 of these claims were related to implantable devices, and the majority of them were for surgical procedures (107 [72%] vs. 41 [28%] for IDDS maintenance).
Of the 107 surgical device procedures, 50% were for an IDDS system, followed by spinal cord stimulator (40%), tunneled epidural (7%), and peripheral nerve stimulator (3%). Temporary minor injury occurred in 74% of the surgical device procedures, followed by permanent cord injury (16%), death/permanent brain damage (8%), and other permanent injury (2%). The most common reasons for permanent spinal cord injury were needle or catheter trauma to the cord (7 cases), epidural hematoma (3 cases), and incorrect placement of the stimulator (2 cases). Infections occurred in 25 of the surgical device procedures. Among these 25 claims, 3 resulted in death or severe permanent injury, 7 involved retained parts and sponges, and 5 were cases of epidural abscess – 4 of which were associated with a tunneled epidural catheter.
Of the 41 damaging events that occurred during IDDS maintenance, 44% were temporary minor injuries, while 32% involved death or permanent brain damage from medication administration errors and 24% involved permanent spinal cord injury, primarily from a delay in recognition of granuloma formation at the catheter tip.
The researchers found that maintenance of IDDS, compared with claims related to other surgical devices, were more commonly associated with a risk of death or permanent damage, less commonly resulted in temporary minor injury, were more likely to have care deemed as substandard, and were more commonly associated with payments (P = .001 for all comparisons). The median payment for all claims was $274,000.
The Anesthesia Closed Claims Project is funded by the Anesthesia Quality Institute. Dr. Fitzgibbon reported having no financial disclosures.
SAN DIEGO – The maintenance of implantable drug delivery systems for the management of chronic pain was associated with death, permanent brain damage, or permanent neurological injury from granuloma, and was largely associated with substandard care.
Those are key findings from an analysis of data from the Anesthesia Closed Claims Project that were presented by Dr. Dermot R. Fitzgibbon at the annual meeting of the American Society of Anesthesiologists.
“Implantable devices are relatively new in chronic pain management, and have only been available since the early 1990s,” said Dr. Fitzgibbon, professor of anesthesiology and pain medicine at the University of Washington, Seattle. Such devices are considered advanced techniques for refractory chronic pain and include implantable drug delivery systems, spinal cord stimulators, and peripheral nerve stimulators. Previous studies have demonstrated that morbidity and mortality from implantable drug delivery systems (IDDS) and spinal cord stimulators typically occur during implantation or removal of devices or during device maintenance (Neuromodulation. 2012;15[5]:467-82 and Clin J Pain. 2007;23[2]:180-95). The purpose of the current study was to investigate liability associated with implantable devices used to manage chronic pain.
Dr. Fitzgibbon and his associates used the Anesthesia Closed Claims Project Database to identify 970 claims related to chronic pain that have occurred since 1990. A total of 148 of these claims were related to implantable devices, and the majority of them were for surgical procedures (107 [72%] vs. 41 [28%] for IDDS maintenance).
Of the 107 surgical device procedures, 50% were for an IDDS system, followed by spinal cord stimulator (40%), tunneled epidural (7%), and peripheral nerve stimulator (3%). Temporary minor injury occurred in 74% of the surgical device procedures, followed by permanent cord injury (16%), death/permanent brain damage (8%), and other permanent injury (2%). The most common reasons for permanent spinal cord injury were needle or catheter trauma to the cord (7 cases), epidural hematoma (3 cases), and incorrect placement of the stimulator (2 cases). Infections occurred in 25 of the surgical device procedures. Among these 25 claims, 3 resulted in death or severe permanent injury, 7 involved retained parts and sponges, and 5 were cases of epidural abscess – 4 of which were associated with a tunneled epidural catheter.
Of the 41 damaging events that occurred during IDDS maintenance, 44% were temporary minor injuries, while 32% involved death or permanent brain damage from medication administration errors and 24% involved permanent spinal cord injury, primarily from a delay in recognition of granuloma formation at the catheter tip.
The researchers found that maintenance of IDDS, compared with claims related to other surgical devices, were more commonly associated with a risk of death or permanent damage, less commonly resulted in temporary minor injury, were more likely to have care deemed as substandard, and were more commonly associated with payments (P = .001 for all comparisons). The median payment for all claims was $274,000.
The Anesthesia Closed Claims Project is funded by the Anesthesia Quality Institute. Dr. Fitzgibbon reported having no financial disclosures.
AT THE ASA ANNUAL MEETING
Key clinical point: Malpractice claims for implantable devices for chronic pain are most often associated with maintenance of implantable drug delivery systems (IDDS) rather than the surgical placement of the devices.
Major finding: Maintenance of IDDS, compared with claims related to other surgical devices, was more commonly associated with a risk of death or permanent damage, less commonly resulted in temporary minor injury, was more likely to have care deemed as substandard, and was more commonly associated with payments (P = .001 for all comparisons).
Data source: An analysis of 970 claims related to chronic pain that have occurred since 1990.
Disclosures: The Anesthesia Closed Claims Project is funded by the Anesthesia Quality Institute. The researchers reported having no financial disclosures.
EADV: Best treatments for great saphenous vein reflux
COPENHAGEN – Superior 5-year outcomes for great saphenous vein reflux were achieved with conventional surgery and endovenous laser ablation as compared with ultrasound-guided foam sclerotherapy in a randomized trial, Dr. Simone van der Velden reported at the annual congress of the European Academy of Dermatology and Venereology.
The multicenter study included 224 randomized legs belonging to symptomatic patients with a target great saphenous vein diameter of at least 5 mm. If deemed necessary, patients could undergo one re-treatment at 3 or 12 months after their initial procedure. At 5 years of follow-up, 86% of the treated legs were available for long-term evaluation, noted Dr. van der Velden of Erasmus University Medical Center in Rotterdam, the Netherlands.
The primary endpoint was obliteration or absence of the treated great saphenous vein segment. This was achieved with conventional surgery in 85% of treated cases, in 77% of legs treated with endovenous laser ablation (EVLA), and in 23% with ultrasound-guided foam sclerotherapy (UGFS).
Absence of above-the-knee greater saphenous vein reflux – a secondary endpoint – was achieved in 85% of the conventional surgery group and in 82% of the EVLA group, both of which were significantly better results than the 41% response with UGFS.
Another secondary endpoint was grade II neovascularization. Here again, both conventional surgery and EVLA outperformed UGFS, with rates of 17%, 13%, and 4%, respectively. In contrast, there was no significant difference between the three treatment groups in terms of the presence of refluxing tributaries above or below knee level, she continued.
Scores on the disease-specific Chronic Venous Insufficiency quality of life Questionnaire (CIVIQ) deteriorated over time in the UGFS group, improved in the EVLA-treated patients, and remained stable in the conventional surgery group.
Conventional surgery was performed under general anesthesia and entailed high ligation of the saphenofemoral junction and phlebectomy of tributaries. In contrast, EVLA was done under local tumescent anesthesia using a 940-nm laser. The laser fiber was introduced at knee level, positioned 1-2 cm below the saphenofemoral junction, and delivered an energy of roughly 60 Joules/cm2.
For UGFS, operators utilized a foam comprising 1 mL of sodium tetradecyl sulfate per 3 mL of air. A maximum of 10 mL of foam could be injected per treatment session, depending upon the diameter of the great saphenous vein and length of the refluxing trunk. Phlebectomies in this group were performed only in the event of patient complaints.
Of note, patients in the minimally invasive UGFS group required re-treatment three times more often than did those in the other two study arms.
Dr. van der Velden said she has heard from some UGFS partisans that she and her coinvestigators may have undertreated patients in that study arm because they didn’t routinely perform phlebectomies of the tributaries, and the average amount of foam they injected, about 4.5 mL, was on the low side.
The study was sponsored by Erasmus University. Dr. van der Velden reported having no financial conflicts of interest.
COPENHAGEN – Superior 5-year outcomes for great saphenous vein reflux were achieved with conventional surgery and endovenous laser ablation as compared with ultrasound-guided foam sclerotherapy in a randomized trial, Dr. Simone van der Velden reported at the annual congress of the European Academy of Dermatology and Venereology.
The multicenter study included 224 randomized legs belonging to symptomatic patients with a target great saphenous vein diameter of at least 5 mm. If deemed necessary, patients could undergo one re-treatment at 3 or 12 months after their initial procedure. At 5 years of follow-up, 86% of the treated legs were available for long-term evaluation, noted Dr. van der Velden of Erasmus University Medical Center in Rotterdam, the Netherlands.
The primary endpoint was obliteration or absence of the treated great saphenous vein segment. This was achieved with conventional surgery in 85% of treated cases, in 77% of legs treated with endovenous laser ablation (EVLA), and in 23% with ultrasound-guided foam sclerotherapy (UGFS).
Absence of above-the-knee greater saphenous vein reflux – a secondary endpoint – was achieved in 85% of the conventional surgery group and in 82% of the EVLA group, both of which were significantly better results than the 41% response with UGFS.
Another secondary endpoint was grade II neovascularization. Here again, both conventional surgery and EVLA outperformed UGFS, with rates of 17%, 13%, and 4%, respectively. In contrast, there was no significant difference between the three treatment groups in terms of the presence of refluxing tributaries above or below knee level, she continued.
Scores on the disease-specific Chronic Venous Insufficiency quality of life Questionnaire (CIVIQ) deteriorated over time in the UGFS group, improved in the EVLA-treated patients, and remained stable in the conventional surgery group.
Conventional surgery was performed under general anesthesia and entailed high ligation of the saphenofemoral junction and phlebectomy of tributaries. In contrast, EVLA was done under local tumescent anesthesia using a 940-nm laser. The laser fiber was introduced at knee level, positioned 1-2 cm below the saphenofemoral junction, and delivered an energy of roughly 60 Joules/cm2.
For UGFS, operators utilized a foam comprising 1 mL of sodium tetradecyl sulfate per 3 mL of air. A maximum of 10 mL of foam could be injected per treatment session, depending upon the diameter of the great saphenous vein and length of the refluxing trunk. Phlebectomies in this group were performed only in the event of patient complaints.
Of note, patients in the minimally invasive UGFS group required re-treatment three times more often than did those in the other two study arms.
Dr. van der Velden said she has heard from some UGFS partisans that she and her coinvestigators may have undertreated patients in that study arm because they didn’t routinely perform phlebectomies of the tributaries, and the average amount of foam they injected, about 4.5 mL, was on the low side.
The study was sponsored by Erasmus University. Dr. van der Velden reported having no financial conflicts of interest.
COPENHAGEN – Superior 5-year outcomes for great saphenous vein reflux were achieved with conventional surgery and endovenous laser ablation as compared with ultrasound-guided foam sclerotherapy in a randomized trial, Dr. Simone van der Velden reported at the annual congress of the European Academy of Dermatology and Venereology.
The multicenter study included 224 randomized legs belonging to symptomatic patients with a target great saphenous vein diameter of at least 5 mm. If deemed necessary, patients could undergo one re-treatment at 3 or 12 months after their initial procedure. At 5 years of follow-up, 86% of the treated legs were available for long-term evaluation, noted Dr. van der Velden of Erasmus University Medical Center in Rotterdam, the Netherlands.
The primary endpoint was obliteration or absence of the treated great saphenous vein segment. This was achieved with conventional surgery in 85% of treated cases, in 77% of legs treated with endovenous laser ablation (EVLA), and in 23% with ultrasound-guided foam sclerotherapy (UGFS).
Absence of above-the-knee greater saphenous vein reflux – a secondary endpoint – was achieved in 85% of the conventional surgery group and in 82% of the EVLA group, both of which were significantly better results than the 41% response with UGFS.
Another secondary endpoint was grade II neovascularization. Here again, both conventional surgery and EVLA outperformed UGFS, with rates of 17%, 13%, and 4%, respectively. In contrast, there was no significant difference between the three treatment groups in terms of the presence of refluxing tributaries above or below knee level, she continued.
Scores on the disease-specific Chronic Venous Insufficiency quality of life Questionnaire (CIVIQ) deteriorated over time in the UGFS group, improved in the EVLA-treated patients, and remained stable in the conventional surgery group.
Conventional surgery was performed under general anesthesia and entailed high ligation of the saphenofemoral junction and phlebectomy of tributaries. In contrast, EVLA was done under local tumescent anesthesia using a 940-nm laser. The laser fiber was introduced at knee level, positioned 1-2 cm below the saphenofemoral junction, and delivered an energy of roughly 60 Joules/cm2.
For UGFS, operators utilized a foam comprising 1 mL of sodium tetradecyl sulfate per 3 mL of air. A maximum of 10 mL of foam could be injected per treatment session, depending upon the diameter of the great saphenous vein and length of the refluxing trunk. Phlebectomies in this group were performed only in the event of patient complaints.
Of note, patients in the minimally invasive UGFS group required re-treatment three times more often than did those in the other two study arms.
Dr. van der Velden said she has heard from some UGFS partisans that she and her coinvestigators may have undertreated patients in that study arm because they didn’t routinely perform phlebectomies of the tributaries, and the average amount of foam they injected, about 4.5 mL, was on the low side.
The study was sponsored by Erasmus University. Dr. van der Velden reported having no financial conflicts of interest.
AT THE EADV CONGRESS
Key clinical point: Long-term outcomes for treatment of great saphenous vein reflux were significantly better with conventional surgery or endovenous laser ablation than with ultrasound-guided foam sclerotherapy.
Major finding: Obliteration or absence of the treated great saphenous vein segment was achieved with conventional surgery in 85% of treated cases, with endovenous laser ablation (EVLA) in 77% of legs treated, and with ultrasound-guided foam sclerotherapy (UGFS) in 23%.
Data source: This multicenter clinical trial with 5-year follow-up included 224 legs randomized to one of three popular treatments for great saphenous varicose veins.
Disclosures: The study was sponsored by Erasmus University. The presenter reported having no financial conflicts of interest.
VIDEO: ASAP 2 trial will test Watchman in warfarin-contraindicated patients
Now that the Watchman device for left atrial appendage closure is on the U.S. market, target patients are those with atrial fibrillation who can tolerate at least a brief, 6-week course of treatment with warfarin – which is what the device’s labeling demands – but are poor candidates for long-term treatment with oral anticoagulation because they have had a serious bleeding episode while on anticoagulant treatment, Dr. Vivek Y. Reddy said in an interview.
Another type of atrial fibrillation patient who is potentially a prime target for Watchman placement are those with a complete contraindication to warfarin treatment, but as of now this makes then ineligible to receive the device. This category of patient will be the target of the ASAP 2 trial, a large, multicenter trial planned to start by the end of 2015 that will randomize atrial fibrillation patients ineligible to receive any oral anticoagulation to receive Watchman followed by a 6-month period of dual antiplatelet therapy or to current standard therapy for such patients with aspirin alone, said Dr. Reddy, professor of medicine and director of the cardiac arrhythmia service at Mount Sinai Hospital in New York.
The ASAP 2 trial follows the pilot study ASAP (ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology) that Dr. Reddy led and ran at four centers in Europe placing Watchman in patients ineligible to receive any oral anticoagulant treatment followed by 6 months of dual antiplatelet therapy. The ASAP results showed that this approach could be safe and effective (J Am Coll Cardiol. 2013 Jun 25;61[25]:2551-6.).
Patients with a total contraindication against treatment with warfarin or another oral anticoagulant “have the greatest need,” said Dr. Reddy. “The problem is we don’t have much safety data” for these patients, and while the results from the ASAP trial showed the device can be safely placed just using dual antiplatelet therapy the numbers were small and the device is not approved for use in this setting, he said.
Dr. Reddy has been an advisor to and received research grants from Atritech/Boston Scientific, the companies that developed and now market Watchman.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
Now that the Watchman device for left atrial appendage closure is on the U.S. market, target patients are those with atrial fibrillation who can tolerate at least a brief, 6-week course of treatment with warfarin – which is what the device’s labeling demands – but are poor candidates for long-term treatment with oral anticoagulation because they have had a serious bleeding episode while on anticoagulant treatment, Dr. Vivek Y. Reddy said in an interview.
Another type of atrial fibrillation patient who is potentially a prime target for Watchman placement are those with a complete contraindication to warfarin treatment, but as of now this makes then ineligible to receive the device. This category of patient will be the target of the ASAP 2 trial, a large, multicenter trial planned to start by the end of 2015 that will randomize atrial fibrillation patients ineligible to receive any oral anticoagulation to receive Watchman followed by a 6-month period of dual antiplatelet therapy or to current standard therapy for such patients with aspirin alone, said Dr. Reddy, professor of medicine and director of the cardiac arrhythmia service at Mount Sinai Hospital in New York.
The ASAP 2 trial follows the pilot study ASAP (ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology) that Dr. Reddy led and ran at four centers in Europe placing Watchman in patients ineligible to receive any oral anticoagulant treatment followed by 6 months of dual antiplatelet therapy. The ASAP results showed that this approach could be safe and effective (J Am Coll Cardiol. 2013 Jun 25;61[25]:2551-6.).
Patients with a total contraindication against treatment with warfarin or another oral anticoagulant “have the greatest need,” said Dr. Reddy. “The problem is we don’t have much safety data” for these patients, and while the results from the ASAP trial showed the device can be safely placed just using dual antiplatelet therapy the numbers were small and the device is not approved for use in this setting, he said.
Dr. Reddy has been an advisor to and received research grants from Atritech/Boston Scientific, the companies that developed and now market Watchman.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
Now that the Watchman device for left atrial appendage closure is on the U.S. market, target patients are those with atrial fibrillation who can tolerate at least a brief, 6-week course of treatment with warfarin – which is what the device’s labeling demands – but are poor candidates for long-term treatment with oral anticoagulation because they have had a serious bleeding episode while on anticoagulant treatment, Dr. Vivek Y. Reddy said in an interview.
Another type of atrial fibrillation patient who is potentially a prime target for Watchman placement are those with a complete contraindication to warfarin treatment, but as of now this makes then ineligible to receive the device. This category of patient will be the target of the ASAP 2 trial, a large, multicenter trial planned to start by the end of 2015 that will randomize atrial fibrillation patients ineligible to receive any oral anticoagulation to receive Watchman followed by a 6-month period of dual antiplatelet therapy or to current standard therapy for such patients with aspirin alone, said Dr. Reddy, professor of medicine and director of the cardiac arrhythmia service at Mount Sinai Hospital in New York.
The ASAP 2 trial follows the pilot study ASAP (ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology) that Dr. Reddy led and ran at four centers in Europe placing Watchman in patients ineligible to receive any oral anticoagulant treatment followed by 6 months of dual antiplatelet therapy. The ASAP results showed that this approach could be safe and effective (J Am Coll Cardiol. 2013 Jun 25;61[25]:2551-6.).
Patients with a total contraindication against treatment with warfarin or another oral anticoagulant “have the greatest need,” said Dr. Reddy. “The problem is we don’t have much safety data” for these patients, and while the results from the ASAP trial showed the device can be safely placed just using dual antiplatelet therapy the numbers were small and the device is not approved for use in this setting, he said.
Dr. Reddy has been an advisor to and received research grants from Atritech/Boston Scientific, the companies that developed and now market Watchman.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @mitchelzoler
TCT: Bivalirudin no better than heparin for preventing post-TAVR bleeding
SAN FRANCISCO – The reversible direct thrombin inhibitor bivalirudin, compared with unfractionated heparin, did not reduce the rate of major bleeding at 48 hours after transcatheter aortic valve replacement, in the randomized, open label, phase IIIb BRAVO 3 trial.
Bivalirudin, which has a half-life of 25 minutes, has been shown to reduce major bleeding in the setting of percutaneous coronary intervention when compared with other regimens, but its safety and efficacy as compared with that of unfractionated heparin was unknown. In BRAVO 3 (The effect of BivaliRudin on Aortic Valve Intervention Outcomes trial), the rate of major bleeding at 48 hours, defined as Bleeding Academic Research Consortium (BARC) 3b or greater, was 6.9% in 404 patients treated with bivalirudin vs. 9.0% in 398 patients treated with heparin (relative risk, 0.77), Dr. Thierry Lefevre reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Further, the rate of net adverse clinical outcomes (NACE), including all-cause mortality, myocardial infarction, stroke, and major bleeding at up to 30 days was 14.4% in the bivalirudin group vs. 16.1% in the heparin group (relative risk, 0.89), Dr. Lefevre of Institut Hospitalier Jacques Cartier, Massy, France, said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The differences on both measures failed to meet statistical significance. With respect to bleeding at 48 hours, bivalirudin did not meet superiority, and with respect to cardiovascular events at 30 days, the prespecified noninferiority hypothesis was met.
No difference was seen between the groups for secondary endpoints, including bleeding defined according to various other bleeding scales and other BARC types.
The findings were published simultaneously in the Journal of the American College of Cardiology (J Am Coll Cardiol. 2015;Oct 15. doi: 10.1016/j.jacc.2015.10.003).
Heparin should remain the standard of care, especially given its lower cost compared to the cost of bivalirudin, Dr. Lefevre said.
However, Dr. Lefevre noted, major bleeding remains an important concern in transcatheter aortic valve replacement (TAVR), and “bivalirudin may be used as an alternative to heparin during TAVR in patients who cannot be treated with UFH.”
BRAVO III participants were adults with aortic stenosis who were at high surgical risk and who were scheduled for TAVR via transfemoral access. They were enrolled at 31 centers in seven countries throughout Europe and North America.
Those randomized to the bivalirudin group received an initial bolus of 0.75 mg/kg followed by a continuous infusion at a rate of 1.75 mg/kg per hour in those with an estimated glomerular filtration rate (eGFR) of 60 mL/min or greater, 1.4 mg/kg per hour in those with eGFR of 30-59 mL/min, and 1.0 mg/kg per hour in those with eGFR lower than 30 mL/min.
Heparin dosing and administration included a recommended target activated clotting time of greater than 25 seconds. Protamine was used for reversal at the end of the procedure based on standard local institution practice.
Session moderator Dr. Ajay J. Kirtane said that “one of the reasons this trial is exciting is that there has been a hypothesis that bivalirudin could reduce bleeding compared to heparin alone in PCI patients. While this is a much bigger access site, you don’t necessarily see these trends. On the other hand, when you have a bigger access site there is potential for increased signal, but this study is still somewhat underpowered.”
The Medicines Company provided funding for the BRAVO 3 trial to the Icahn School of Medicine at Mount Sinai, New York. Dr. Lefevre disclosed ties with Boston Scientific, Directflow, Edwards, Symetis and Medtronic.
SAN FRANCISCO – The reversible direct thrombin inhibitor bivalirudin, compared with unfractionated heparin, did not reduce the rate of major bleeding at 48 hours after transcatheter aortic valve replacement, in the randomized, open label, phase IIIb BRAVO 3 trial.
Bivalirudin, which has a half-life of 25 minutes, has been shown to reduce major bleeding in the setting of percutaneous coronary intervention when compared with other regimens, but its safety and efficacy as compared with that of unfractionated heparin was unknown. In BRAVO 3 (The effect of BivaliRudin on Aortic Valve Intervention Outcomes trial), the rate of major bleeding at 48 hours, defined as Bleeding Academic Research Consortium (BARC) 3b or greater, was 6.9% in 404 patients treated with bivalirudin vs. 9.0% in 398 patients treated with heparin (relative risk, 0.77), Dr. Thierry Lefevre reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Further, the rate of net adverse clinical outcomes (NACE), including all-cause mortality, myocardial infarction, stroke, and major bleeding at up to 30 days was 14.4% in the bivalirudin group vs. 16.1% in the heparin group (relative risk, 0.89), Dr. Lefevre of Institut Hospitalier Jacques Cartier, Massy, France, said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The differences on both measures failed to meet statistical significance. With respect to bleeding at 48 hours, bivalirudin did not meet superiority, and with respect to cardiovascular events at 30 days, the prespecified noninferiority hypothesis was met.
No difference was seen between the groups for secondary endpoints, including bleeding defined according to various other bleeding scales and other BARC types.
The findings were published simultaneously in the Journal of the American College of Cardiology (J Am Coll Cardiol. 2015;Oct 15. doi: 10.1016/j.jacc.2015.10.003).
Heparin should remain the standard of care, especially given its lower cost compared to the cost of bivalirudin, Dr. Lefevre said.
However, Dr. Lefevre noted, major bleeding remains an important concern in transcatheter aortic valve replacement (TAVR), and “bivalirudin may be used as an alternative to heparin during TAVR in patients who cannot be treated with UFH.”
BRAVO III participants were adults with aortic stenosis who were at high surgical risk and who were scheduled for TAVR via transfemoral access. They were enrolled at 31 centers in seven countries throughout Europe and North America.
Those randomized to the bivalirudin group received an initial bolus of 0.75 mg/kg followed by a continuous infusion at a rate of 1.75 mg/kg per hour in those with an estimated glomerular filtration rate (eGFR) of 60 mL/min or greater, 1.4 mg/kg per hour in those with eGFR of 30-59 mL/min, and 1.0 mg/kg per hour in those with eGFR lower than 30 mL/min.
Heparin dosing and administration included a recommended target activated clotting time of greater than 25 seconds. Protamine was used for reversal at the end of the procedure based on standard local institution practice.
Session moderator Dr. Ajay J. Kirtane said that “one of the reasons this trial is exciting is that there has been a hypothesis that bivalirudin could reduce bleeding compared to heparin alone in PCI patients. While this is a much bigger access site, you don’t necessarily see these trends. On the other hand, when you have a bigger access site there is potential for increased signal, but this study is still somewhat underpowered.”
The Medicines Company provided funding for the BRAVO 3 trial to the Icahn School of Medicine at Mount Sinai, New York. Dr. Lefevre disclosed ties with Boston Scientific, Directflow, Edwards, Symetis and Medtronic.
SAN FRANCISCO – The reversible direct thrombin inhibitor bivalirudin, compared with unfractionated heparin, did not reduce the rate of major bleeding at 48 hours after transcatheter aortic valve replacement, in the randomized, open label, phase IIIb BRAVO 3 trial.
Bivalirudin, which has a half-life of 25 minutes, has been shown to reduce major bleeding in the setting of percutaneous coronary intervention when compared with other regimens, but its safety and efficacy as compared with that of unfractionated heparin was unknown. In BRAVO 3 (The effect of BivaliRudin on Aortic Valve Intervention Outcomes trial), the rate of major bleeding at 48 hours, defined as Bleeding Academic Research Consortium (BARC) 3b or greater, was 6.9% in 404 patients treated with bivalirudin vs. 9.0% in 398 patients treated with heparin (relative risk, 0.77), Dr. Thierry Lefevre reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Further, the rate of net adverse clinical outcomes (NACE), including all-cause mortality, myocardial infarction, stroke, and major bleeding at up to 30 days was 14.4% in the bivalirudin group vs. 16.1% in the heparin group (relative risk, 0.89), Dr. Lefevre of Institut Hospitalier Jacques Cartier, Massy, France, said at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The differences on both measures failed to meet statistical significance. With respect to bleeding at 48 hours, bivalirudin did not meet superiority, and with respect to cardiovascular events at 30 days, the prespecified noninferiority hypothesis was met.
No difference was seen between the groups for secondary endpoints, including bleeding defined according to various other bleeding scales and other BARC types.
The findings were published simultaneously in the Journal of the American College of Cardiology (J Am Coll Cardiol. 2015;Oct 15. doi: 10.1016/j.jacc.2015.10.003).
Heparin should remain the standard of care, especially given its lower cost compared to the cost of bivalirudin, Dr. Lefevre said.
However, Dr. Lefevre noted, major bleeding remains an important concern in transcatheter aortic valve replacement (TAVR), and “bivalirudin may be used as an alternative to heparin during TAVR in patients who cannot be treated with UFH.”
BRAVO III participants were adults with aortic stenosis who were at high surgical risk and who were scheduled for TAVR via transfemoral access. They were enrolled at 31 centers in seven countries throughout Europe and North America.
Those randomized to the bivalirudin group received an initial bolus of 0.75 mg/kg followed by a continuous infusion at a rate of 1.75 mg/kg per hour in those with an estimated glomerular filtration rate (eGFR) of 60 mL/min or greater, 1.4 mg/kg per hour in those with eGFR of 30-59 mL/min, and 1.0 mg/kg per hour in those with eGFR lower than 30 mL/min.
Heparin dosing and administration included a recommended target activated clotting time of greater than 25 seconds. Protamine was used for reversal at the end of the procedure based on standard local institution practice.
Session moderator Dr. Ajay J. Kirtane said that “one of the reasons this trial is exciting is that there has been a hypothesis that bivalirudin could reduce bleeding compared to heparin alone in PCI patients. While this is a much bigger access site, you don’t necessarily see these trends. On the other hand, when you have a bigger access site there is potential for increased signal, but this study is still somewhat underpowered.”
The Medicines Company provided funding for the BRAVO 3 trial to the Icahn School of Medicine at Mount Sinai, New York. Dr. Lefevre disclosed ties with Boston Scientific, Directflow, Edwards, Symetis and Medtronic.
AT TCT 2015
Key clinical point: The reversible direct thrombin inhibitor bivalirudin did not reduce the rate of major bleeding at 48 hours after transcatheter aortic valve replacement, compared with unfractionated heparin, in the BRAVO 3 trial.
Major finding: The rate of major bleeding at 48 hours was 6.9% vs. 9.0% in patients treated with bivalirudin vs. heparin (relative risk, 0.77).
Data source: A randomized, open-label, phase IIIb study of 802 patients.
Disclosures: The Medicines Company provided funding for the BRAVO 3 trial to the Icahn School of Medicine at Mount Sinai, New York. Dr. Lefevre disclosed ties with Boston Scientific, Directflow, Edwards, Symetis and Medtronic.
Midair medical emergencies
Question: One hour into an Air France international flight out of New York, Dr. Internist responded to a call for emergency medical assistance. A U.S. passenger had briefly passed out but then appeared to recover. Dr. Internist made a tentative diagnosis of a transient ischemic attack, but did not think an immediate divert was necessary. Based on the doctor’s assessment, the pilot continued on the previously scheduled flight path, landing several hours later in Paris. Meanwhile, the passenger’s condition worsened, and he expired shortly after arrival.
Which of the following statements is correct?
A. Under the common law, there is no legal duty to aid a stranger in distress; but under French law, a doctor is legally obligated to provide emergency assistance.
B. The U.S. federal Aviation Medical Assistance Act may immunize the doctor against liability for negligence during a midair medical emergency.
C. A tort action may still lie against the airline, notwithstanding the doctor’s advice not to divert.
D. Expect jurisdictional conflicts in the event there is a lawsuit.
E. All are correct.
Answer: E. Under the common law, there is no legal duty for anyone, even a doctor, to come to the aid of a stranger. However, doctors are generally held to have an ethical duty to offer emergency care. The American Medical Association’s Code of Medical Ethics states: “Physicians are free to choose whom they will serve. The physician should, however, respond to the best of his or her ability in cases of emergency where first aid treatment is essential.”1
In contrast, Australia and most civil law jurisdictions, e.g., many European countries, impose a legal obligation to render assistance. Under French law, for example, failure to render assistance to a person in urgent need of help can be met with fines of up to 75,000 euros and 5 years imprisonment.
Medical “emergencies” occur in roughly 1 of every 600 flights, which may be an underestimate because of underreporting. The most common medical reasons for aircraft diversion are cardiac, respiratory, and neurologic emergencies. According to a recent review in the New England Journal of Medicine, the decision to divert lies solely with the captain of the aircraft, who must also consider factors such as fuel, costs, the ability to land, and the medical resources available at that airport.2 The review also summarizes medical steps to be taken during midair medical emergencies.
Two related laws other than international aviation treaties govern medical liability during commercial flights: the generic “Good Samaritan” statute, which all 50 U.S. states have enacted, and the more specific federal Aviation Medical Assistance Act.
In 1959, California enacted the first Good Samaritan statute, whose intent is to encourage the helping of people in distress. In general, the law protects against liability arising out of nonreimbursed negligent rescue, but it does not affirmatively require doctors to come to the aid of strangers. Vermont, however, is an exception, and imposes a legal duty to assist a victim in need.
Typically, there is legal immunity against ordinary negligence but not gross misconduct, although California appears to excuse even gross negligence so long as the act was done in good faith. In a litigated case, a California court eloquently declared: “The goodness of the Samaritan is a description of the quality of his or her intention, not the quality of the aid delivered.”3
There is no universal definition of gross negligence, but the term frequently is equated with willful, wanton, or reckless conduct. One can think of gross negligence as aggravated negligence, involving more than mere mistake, inadvertence, or inattention, and representing highly unreasonable conduct or an extreme departure from ordinary care where a high degree of danger is apparent.4 An example may be an obviously inebriated physician attempting to provide treatment and causing harm to the victim.
However, the Good Samaritan statute, being state based, may not be applicable to scenarios with cross-border jurisdictional issues. The specific law that incorporates Good Samaritan assistance during commercial flights is the federal Aviation Medical Assistance Act (AMAA), which Congress enacted in 1998. In addition to Federal Aviation Administration mandates such as requisite medical supplies on board and training of flight crew, this federal law shields providers who respond to in-flight medical emergencies.
The AMAA covers claims arising from domestic flights and those arising from international flights involving U.S. carriers or residents, but it does not protect a provider who exhibits flagrant disregard for the patient’s health and safety. Liability is generally determined under the law of the country in which the aircraft is registered, but the citizenship status of the parties and where the incident occurs are also relevant.5
Under the facts of the hypothetical given above, one can expect jurisdictional conflicts in the event the plaintiff files a lawsuit, because it is unclear whether the AMAA is applicable where a foreign airline is on an international flight over the Atlantic, even one out of New York involving a U.S. citizen.
There does not appear to be an appellate court opinion on physician negligence during an in-flight medical emergency, but there have been lower court decisions and settlements adverse to the airline.6
For example, Northwest Airlines reportedly settled out of court following the death of a passenger on a flight from Manila to Tokyo, despite its claim that three doctors on board the aircraft did not feel an emergency landing was warranted. In a similar case, a Miami federal judge ordered Lufthansa German Airlines to pay damages of $2.7 million to a passenger having a heart attack during a 9-hour flight, after the captain heeded the recommendation from a doctor on board against diverting. In neither case were the doctors apparently named as defendants.
In summary, a doctor is ethically obligated to provide medical assistance in a midair emergency situation. It is highly unlikely that any adverse legal repercussion will ensue. Good Samaritan statutes and, more specifically, the AMAA, properly provide immunity against any allegation of ordinary negligence. Finally, one should be mindful of the need for the patient’s consent before examination and treatment, and, as always, keep written notes of what you have done.
References
1. AMA Code of Medical Ethics §8.11, 2012-2013 edition.
2. N Engl J Med. 2015 Sep 3;373(10):939-45.
3. Perkins v. Howard, 232 Cal.App.3d 708 (1991).
4. Prosser and Keeton on Torts, 5th ed. 1984, p. 211-4.
5. Aviation Medical Assistance Act of 1998, Pub L. No. 105-170. Washington, DC.
6. Aviat Space Environ Med. 1997 Dec;68(12):1134-8.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.
Question: One hour into an Air France international flight out of New York, Dr. Internist responded to a call for emergency medical assistance. A U.S. passenger had briefly passed out but then appeared to recover. Dr. Internist made a tentative diagnosis of a transient ischemic attack, but did not think an immediate divert was necessary. Based on the doctor’s assessment, the pilot continued on the previously scheduled flight path, landing several hours later in Paris. Meanwhile, the passenger’s condition worsened, and he expired shortly after arrival.
Which of the following statements is correct?
A. Under the common law, there is no legal duty to aid a stranger in distress; but under French law, a doctor is legally obligated to provide emergency assistance.
B. The U.S. federal Aviation Medical Assistance Act may immunize the doctor against liability for negligence during a midair medical emergency.
C. A tort action may still lie against the airline, notwithstanding the doctor’s advice not to divert.
D. Expect jurisdictional conflicts in the event there is a lawsuit.
E. All are correct.
Answer: E. Under the common law, there is no legal duty for anyone, even a doctor, to come to the aid of a stranger. However, doctors are generally held to have an ethical duty to offer emergency care. The American Medical Association’s Code of Medical Ethics states: “Physicians are free to choose whom they will serve. The physician should, however, respond to the best of his or her ability in cases of emergency where first aid treatment is essential.”1
In contrast, Australia and most civil law jurisdictions, e.g., many European countries, impose a legal obligation to render assistance. Under French law, for example, failure to render assistance to a person in urgent need of help can be met with fines of up to 75,000 euros and 5 years imprisonment.
Medical “emergencies” occur in roughly 1 of every 600 flights, which may be an underestimate because of underreporting. The most common medical reasons for aircraft diversion are cardiac, respiratory, and neurologic emergencies. According to a recent review in the New England Journal of Medicine, the decision to divert lies solely with the captain of the aircraft, who must also consider factors such as fuel, costs, the ability to land, and the medical resources available at that airport.2 The review also summarizes medical steps to be taken during midair medical emergencies.
Two related laws other than international aviation treaties govern medical liability during commercial flights: the generic “Good Samaritan” statute, which all 50 U.S. states have enacted, and the more specific federal Aviation Medical Assistance Act.
In 1959, California enacted the first Good Samaritan statute, whose intent is to encourage the helping of people in distress. In general, the law protects against liability arising out of nonreimbursed negligent rescue, but it does not affirmatively require doctors to come to the aid of strangers. Vermont, however, is an exception, and imposes a legal duty to assist a victim in need.
Typically, there is legal immunity against ordinary negligence but not gross misconduct, although California appears to excuse even gross negligence so long as the act was done in good faith. In a litigated case, a California court eloquently declared: “The goodness of the Samaritan is a description of the quality of his or her intention, not the quality of the aid delivered.”3
There is no universal definition of gross negligence, but the term frequently is equated with willful, wanton, or reckless conduct. One can think of gross negligence as aggravated negligence, involving more than mere mistake, inadvertence, or inattention, and representing highly unreasonable conduct or an extreme departure from ordinary care where a high degree of danger is apparent.4 An example may be an obviously inebriated physician attempting to provide treatment and causing harm to the victim.
However, the Good Samaritan statute, being state based, may not be applicable to scenarios with cross-border jurisdictional issues. The specific law that incorporates Good Samaritan assistance during commercial flights is the federal Aviation Medical Assistance Act (AMAA), which Congress enacted in 1998. In addition to Federal Aviation Administration mandates such as requisite medical supplies on board and training of flight crew, this federal law shields providers who respond to in-flight medical emergencies.
The AMAA covers claims arising from domestic flights and those arising from international flights involving U.S. carriers or residents, but it does not protect a provider who exhibits flagrant disregard for the patient’s health and safety. Liability is generally determined under the law of the country in which the aircraft is registered, but the citizenship status of the parties and where the incident occurs are also relevant.5
Under the facts of the hypothetical given above, one can expect jurisdictional conflicts in the event the plaintiff files a lawsuit, because it is unclear whether the AMAA is applicable where a foreign airline is on an international flight over the Atlantic, even one out of New York involving a U.S. citizen.
There does not appear to be an appellate court opinion on physician negligence during an in-flight medical emergency, but there have been lower court decisions and settlements adverse to the airline.6
For example, Northwest Airlines reportedly settled out of court following the death of a passenger on a flight from Manila to Tokyo, despite its claim that three doctors on board the aircraft did not feel an emergency landing was warranted. In a similar case, a Miami federal judge ordered Lufthansa German Airlines to pay damages of $2.7 million to a passenger having a heart attack during a 9-hour flight, after the captain heeded the recommendation from a doctor on board against diverting. In neither case were the doctors apparently named as defendants.
In summary, a doctor is ethically obligated to provide medical assistance in a midair emergency situation. It is highly unlikely that any adverse legal repercussion will ensue. Good Samaritan statutes and, more specifically, the AMAA, properly provide immunity against any allegation of ordinary negligence. Finally, one should be mindful of the need for the patient’s consent before examination and treatment, and, as always, keep written notes of what you have done.
References
1. AMA Code of Medical Ethics §8.11, 2012-2013 edition.
2. N Engl J Med. 2015 Sep 3;373(10):939-45.
3. Perkins v. Howard, 232 Cal.App.3d 708 (1991).
4. Prosser and Keeton on Torts, 5th ed. 1984, p. 211-4.
5. Aviation Medical Assistance Act of 1998, Pub L. No. 105-170. Washington, DC.
6. Aviat Space Environ Med. 1997 Dec;68(12):1134-8.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.
Question: One hour into an Air France international flight out of New York, Dr. Internist responded to a call for emergency medical assistance. A U.S. passenger had briefly passed out but then appeared to recover. Dr. Internist made a tentative diagnosis of a transient ischemic attack, but did not think an immediate divert was necessary. Based on the doctor’s assessment, the pilot continued on the previously scheduled flight path, landing several hours later in Paris. Meanwhile, the passenger’s condition worsened, and he expired shortly after arrival.
Which of the following statements is correct?
A. Under the common law, there is no legal duty to aid a stranger in distress; but under French law, a doctor is legally obligated to provide emergency assistance.
B. The U.S. federal Aviation Medical Assistance Act may immunize the doctor against liability for negligence during a midair medical emergency.
C. A tort action may still lie against the airline, notwithstanding the doctor’s advice not to divert.
D. Expect jurisdictional conflicts in the event there is a lawsuit.
E. All are correct.
Answer: E. Under the common law, there is no legal duty for anyone, even a doctor, to come to the aid of a stranger. However, doctors are generally held to have an ethical duty to offer emergency care. The American Medical Association’s Code of Medical Ethics states: “Physicians are free to choose whom they will serve. The physician should, however, respond to the best of his or her ability in cases of emergency where first aid treatment is essential.”1
In contrast, Australia and most civil law jurisdictions, e.g., many European countries, impose a legal obligation to render assistance. Under French law, for example, failure to render assistance to a person in urgent need of help can be met with fines of up to 75,000 euros and 5 years imprisonment.
Medical “emergencies” occur in roughly 1 of every 600 flights, which may be an underestimate because of underreporting. The most common medical reasons for aircraft diversion are cardiac, respiratory, and neurologic emergencies. According to a recent review in the New England Journal of Medicine, the decision to divert lies solely with the captain of the aircraft, who must also consider factors such as fuel, costs, the ability to land, and the medical resources available at that airport.2 The review also summarizes medical steps to be taken during midair medical emergencies.
Two related laws other than international aviation treaties govern medical liability during commercial flights: the generic “Good Samaritan” statute, which all 50 U.S. states have enacted, and the more specific federal Aviation Medical Assistance Act.
In 1959, California enacted the first Good Samaritan statute, whose intent is to encourage the helping of people in distress. In general, the law protects against liability arising out of nonreimbursed negligent rescue, but it does not affirmatively require doctors to come to the aid of strangers. Vermont, however, is an exception, and imposes a legal duty to assist a victim in need.
Typically, there is legal immunity against ordinary negligence but not gross misconduct, although California appears to excuse even gross negligence so long as the act was done in good faith. In a litigated case, a California court eloquently declared: “The goodness of the Samaritan is a description of the quality of his or her intention, not the quality of the aid delivered.”3
There is no universal definition of gross negligence, but the term frequently is equated with willful, wanton, or reckless conduct. One can think of gross negligence as aggravated negligence, involving more than mere mistake, inadvertence, or inattention, and representing highly unreasonable conduct or an extreme departure from ordinary care where a high degree of danger is apparent.4 An example may be an obviously inebriated physician attempting to provide treatment and causing harm to the victim.
However, the Good Samaritan statute, being state based, may not be applicable to scenarios with cross-border jurisdictional issues. The specific law that incorporates Good Samaritan assistance during commercial flights is the federal Aviation Medical Assistance Act (AMAA), which Congress enacted in 1998. In addition to Federal Aviation Administration mandates such as requisite medical supplies on board and training of flight crew, this federal law shields providers who respond to in-flight medical emergencies.
The AMAA covers claims arising from domestic flights and those arising from international flights involving U.S. carriers or residents, but it does not protect a provider who exhibits flagrant disregard for the patient’s health and safety. Liability is generally determined under the law of the country in which the aircraft is registered, but the citizenship status of the parties and where the incident occurs are also relevant.5
Under the facts of the hypothetical given above, one can expect jurisdictional conflicts in the event the plaintiff files a lawsuit, because it is unclear whether the AMAA is applicable where a foreign airline is on an international flight over the Atlantic, even one out of New York involving a U.S. citizen.
There does not appear to be an appellate court opinion on physician negligence during an in-flight medical emergency, but there have been lower court decisions and settlements adverse to the airline.6
For example, Northwest Airlines reportedly settled out of court following the death of a passenger on a flight from Manila to Tokyo, despite its claim that three doctors on board the aircraft did not feel an emergency landing was warranted. In a similar case, a Miami federal judge ordered Lufthansa German Airlines to pay damages of $2.7 million to a passenger having a heart attack during a 9-hour flight, after the captain heeded the recommendation from a doctor on board against diverting. In neither case were the doctors apparently named as defendants.
In summary, a doctor is ethically obligated to provide medical assistance in a midair emergency situation. It is highly unlikely that any adverse legal repercussion will ensue. Good Samaritan statutes and, more specifically, the AMAA, properly provide immunity against any allegation of ordinary negligence. Finally, one should be mindful of the need for the patient’s consent before examination and treatment, and, as always, keep written notes of what you have done.
References
1. AMA Code of Medical Ethics §8.11, 2012-2013 edition.
2. N Engl J Med. 2015 Sep 3;373(10):939-45.
3. Perkins v. Howard, 232 Cal.App.3d 708 (1991).
4. Prosser and Keeton on Torts, 5th ed. 1984, p. 211-4.
5. Aviation Medical Assistance Act of 1998, Pub L. No. 105-170. Washington, DC.
6. Aviat Space Environ Med. 1997 Dec;68(12):1134-8.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.
TCT: Early intervention cut mortality in severe, asymptomatic AS
SAN FRANCISCO - Early valve replacement may be in the best interest of asymptomatic patients with severe aortic stenosis, possibly halving their 5-year risk of death, based on data from the CURRENT AS registry study.
Compared to watchful waiting, early surgical intervention also reduced by 81% the risk of hospitalization for heart failure, Dr. Tomohiko Taniguchi said at the Transcatheter Cardiovascular Therapeutics annual meeting. The study was simultaneously published in the Journal of the American College of Cardiology (Am Coll Cardiol. 2015. doi: 10.1016/j.jacc.2015.10.001).
Observation has been the byword for asymptomatic patients with severe aortic stenosis (AS). The American College of Cardiology recommends a conservative approach to the asymptomatic AS patient, but acknowledges the disorder inevitably progresses in nearly all patients. In the ACC’s 2014 treatment guidelines, survival during the asymptomatic phase is similar to that of age-matched controls when patients are carefully followed.
But the CURRENT AS registry results suggest that “the long-term outcome of asymptomatic patients with severe aortic stenosis was dismal when they were managed conservatively in real clinical practice,” Dr. Taniguchi said during a press briefing at the meeting, which was sponsored by the Cardiovascular Research Foundation.
“If you’re watching and waiting, and you wait for sudden death, then that is a problem,” said Dr. Ajay J. Kirtane, who moderated the briefing. Early intervention “potentially changes the game because we do have a less-invasive procedure we can offer – transcatheter aortic valve replacement (AVR),” said Dr. Kirtane of New York-Presbyterian Hospital.
In the CURRENT AS study, severe AS was considered a peak aortic jet velocity over 4.0 m/s, or a mean aortic pressure gradient greater than 40 mm Hg, or an aortic valve area less than 1.0 cm2. The registry includes 3,815 patients; Dr. Taniguchi of Kyoto University reported outcomes for a propensity-score matched cohort of 582 patients, 291 in the initial AVR group and 291 in the conservatively managed group. There was no treatment randomization; treatment decisions were made at the clinical level.
Patients in the matched cohort were in their early 70s; in 80%, the AS etiology was degenerative. The mean aortic pressure gradient was 54 mm Hg in the early intervention group and 45 mm Hg in the watchful waiting group. In 79% of the early intervention group and in 54% of the watchful waiting group, the mean aortic pressure gradient was below 40 mm Hg.
Among the patients who underwent AVR despite being asymptomatic, most (63%) had at least one surgical indication, including severe AS (41%), left ventricular dysfunction (7%), rapid hemodynamic progression (11%), or active infective endocarditis (0.3%). Other cardiac surgery indications were present in 8%. Many of the conservatively managed patients (41%) did eventually require AVR, Dr. Taniguchi noted.
By the end of the 5-year follow up period, 26% of the conservative therapy group and 15% of the early AVR group had died – a significant difference (hazard ratio, 0.64; P = .02).
The coprimary endpoint of heart failure hospitalization was also significantly more common among the conservatively treated group (19.9% vs. 3.8%; HR, 0.19; P less than .001).
The early intervention group also did significantly better on several secondary clinical outcomes, including cardiovascular death (10% vs. 18.6%), aortic valve-related death (5.3% vs. 13.5%), sudden death (3.6% vs. 5.8%), and emerging symptoms (3.2% vs. 46.3%).
Dr. Taniguchi had no financial disclosures. The study was sponsored by Kyoto University.
The findings make a good case for carefully considering which patients might benefit more from early intervention than from close observation. They also suggest a place for less invasive valve replacement rather than watchful waiting in some asymptomatic patients.
|
Dr. Jeffrey Popma |
I think this finding is fabulous, and raises the question of whether the ventricle cares even if the patient doesn’t care. Should we be intervening earlier with transcatheter aortic valve replacement? A less-invasive therapy early on may have benefits.
Dr. Jeffrey J. Popma is professor of medicine at Harvard Medical School and director of interventional cardiology at the Beth Israel Deaconess Medical Center, both in Boston.
The findings make a good case for carefully considering which patients might benefit more from early intervention than from close observation. They also suggest a place for less invasive valve replacement rather than watchful waiting in some asymptomatic patients.
|
|
Dr. Jeffrey Popma |
I think this finding is fabulous, and raises the question of whether the ventricle cares even if the patient doesn’t care. Should we be intervening earlier with transcatheter aortic valve replacement? A less-invasive therapy early on may have benefits.
Dr. Jeffrey J. Popma is professor of medicine at Harvard Medical School and director of interventional cardiology at the Beth Israel Deaconess Medical Center, both in Boston.
The findings make a good case for carefully considering which patients might benefit more from early intervention than from close observation. They also suggest a place for less invasive valve replacement rather than watchful waiting in some asymptomatic patients.
|
|
Dr. Jeffrey Popma |
I think this finding is fabulous, and raises the question of whether the ventricle cares even if the patient doesn’t care. Should we be intervening earlier with transcatheter aortic valve replacement? A less-invasive therapy early on may have benefits.
Dr. Jeffrey J. Popma is professor of medicine at Harvard Medical School and director of interventional cardiology at the Beth Israel Deaconess Medical Center, both in Boston.
SAN FRANCISCO - Early valve replacement may be in the best interest of asymptomatic patients with severe aortic stenosis, possibly halving their 5-year risk of death, based on data from the CURRENT AS registry study.
Compared to watchful waiting, early surgical intervention also reduced by 81% the risk of hospitalization for heart failure, Dr. Tomohiko Taniguchi said at the Transcatheter Cardiovascular Therapeutics annual meeting. The study was simultaneously published in the Journal of the American College of Cardiology (Am Coll Cardiol. 2015. doi: 10.1016/j.jacc.2015.10.001).
Observation has been the byword for asymptomatic patients with severe aortic stenosis (AS). The American College of Cardiology recommends a conservative approach to the asymptomatic AS patient, but acknowledges the disorder inevitably progresses in nearly all patients. In the ACC’s 2014 treatment guidelines, survival during the asymptomatic phase is similar to that of age-matched controls when patients are carefully followed.
But the CURRENT AS registry results suggest that “the long-term outcome of asymptomatic patients with severe aortic stenosis was dismal when they were managed conservatively in real clinical practice,” Dr. Taniguchi said during a press briefing at the meeting, which was sponsored by the Cardiovascular Research Foundation.
“If you’re watching and waiting, and you wait for sudden death, then that is a problem,” said Dr. Ajay J. Kirtane, who moderated the briefing. Early intervention “potentially changes the game because we do have a less-invasive procedure we can offer – transcatheter aortic valve replacement (AVR),” said Dr. Kirtane of New York-Presbyterian Hospital.
In the CURRENT AS study, severe AS was considered a peak aortic jet velocity over 4.0 m/s, or a mean aortic pressure gradient greater than 40 mm Hg, or an aortic valve area less than 1.0 cm2. The registry includes 3,815 patients; Dr. Taniguchi of Kyoto University reported outcomes for a propensity-score matched cohort of 582 patients, 291 in the initial AVR group and 291 in the conservatively managed group. There was no treatment randomization; treatment decisions were made at the clinical level.
Patients in the matched cohort were in their early 70s; in 80%, the AS etiology was degenerative. The mean aortic pressure gradient was 54 mm Hg in the early intervention group and 45 mm Hg in the watchful waiting group. In 79% of the early intervention group and in 54% of the watchful waiting group, the mean aortic pressure gradient was below 40 mm Hg.
Among the patients who underwent AVR despite being asymptomatic, most (63%) had at least one surgical indication, including severe AS (41%), left ventricular dysfunction (7%), rapid hemodynamic progression (11%), or active infective endocarditis (0.3%). Other cardiac surgery indications were present in 8%. Many of the conservatively managed patients (41%) did eventually require AVR, Dr. Taniguchi noted.
By the end of the 5-year follow up period, 26% of the conservative therapy group and 15% of the early AVR group had died – a significant difference (hazard ratio, 0.64; P = .02).
The coprimary endpoint of heart failure hospitalization was also significantly more common among the conservatively treated group (19.9% vs. 3.8%; HR, 0.19; P less than .001).
The early intervention group also did significantly better on several secondary clinical outcomes, including cardiovascular death (10% vs. 18.6%), aortic valve-related death (5.3% vs. 13.5%), sudden death (3.6% vs. 5.8%), and emerging symptoms (3.2% vs. 46.3%).
Dr. Taniguchi had no financial disclosures. The study was sponsored by Kyoto University.
SAN FRANCISCO - Early valve replacement may be in the best interest of asymptomatic patients with severe aortic stenosis, possibly halving their 5-year risk of death, based on data from the CURRENT AS registry study.
Compared to watchful waiting, early surgical intervention also reduced by 81% the risk of hospitalization for heart failure, Dr. Tomohiko Taniguchi said at the Transcatheter Cardiovascular Therapeutics annual meeting. The study was simultaneously published in the Journal of the American College of Cardiology (Am Coll Cardiol. 2015. doi: 10.1016/j.jacc.2015.10.001).
Observation has been the byword for asymptomatic patients with severe aortic stenosis (AS). The American College of Cardiology recommends a conservative approach to the asymptomatic AS patient, but acknowledges the disorder inevitably progresses in nearly all patients. In the ACC’s 2014 treatment guidelines, survival during the asymptomatic phase is similar to that of age-matched controls when patients are carefully followed.
But the CURRENT AS registry results suggest that “the long-term outcome of asymptomatic patients with severe aortic stenosis was dismal when they were managed conservatively in real clinical practice,” Dr. Taniguchi said during a press briefing at the meeting, which was sponsored by the Cardiovascular Research Foundation.
“If you’re watching and waiting, and you wait for sudden death, then that is a problem,” said Dr. Ajay J. Kirtane, who moderated the briefing. Early intervention “potentially changes the game because we do have a less-invasive procedure we can offer – transcatheter aortic valve replacement (AVR),” said Dr. Kirtane of New York-Presbyterian Hospital.
In the CURRENT AS study, severe AS was considered a peak aortic jet velocity over 4.0 m/s, or a mean aortic pressure gradient greater than 40 mm Hg, or an aortic valve area less than 1.0 cm2. The registry includes 3,815 patients; Dr. Taniguchi of Kyoto University reported outcomes for a propensity-score matched cohort of 582 patients, 291 in the initial AVR group and 291 in the conservatively managed group. There was no treatment randomization; treatment decisions were made at the clinical level.
Patients in the matched cohort were in their early 70s; in 80%, the AS etiology was degenerative. The mean aortic pressure gradient was 54 mm Hg in the early intervention group and 45 mm Hg in the watchful waiting group. In 79% of the early intervention group and in 54% of the watchful waiting group, the mean aortic pressure gradient was below 40 mm Hg.
Among the patients who underwent AVR despite being asymptomatic, most (63%) had at least one surgical indication, including severe AS (41%), left ventricular dysfunction (7%), rapid hemodynamic progression (11%), or active infective endocarditis (0.3%). Other cardiac surgery indications were present in 8%. Many of the conservatively managed patients (41%) did eventually require AVR, Dr. Taniguchi noted.
By the end of the 5-year follow up period, 26% of the conservative therapy group and 15% of the early AVR group had died – a significant difference (hazard ratio, 0.64; P = .02).
The coprimary endpoint of heart failure hospitalization was also significantly more common among the conservatively treated group (19.9% vs. 3.8%; HR, 0.19; P less than .001).
The early intervention group also did significantly better on several secondary clinical outcomes, including cardiovascular death (10% vs. 18.6%), aortic valve-related death (5.3% vs. 13.5%), sudden death (3.6% vs. 5.8%), and emerging symptoms (3.2% vs. 46.3%).
Dr. Taniguchi had no financial disclosures. The study was sponsored by Kyoto University.
Early TIPS tied to mortality reduction in esophageal bleeds
HONOLULU – Early use of a transjugular intrahepatic portosystemic shunt (TIPS) is associated with substantial reductions in mortality, according to an analysis of a national inpatient database.
Based on this study, “early use of TIPS, together with patient and physician education on current guidelines and protocols, should continue to be a priority to improve patient outcomes” in patients with hepatic cirrhosis and risk of recurrent esophageal variceal bleeds, reported Dr. Basile Njei, a gastroenterology fellow at Yale University, New Haven, Conn.
In this study, the Nationwide Inpatient Sample database was queried by ICD-9 codes to identify patients with esophageal variceal bleeding treated between the years 2000 and 2010. The goal was to compare early use of TIPS, defined as TIPS administered within 72 hours of the bleeding, relative to rescue TIPS, defined as TIPS after two or more episodes of bleeding or one bleeding episode followed by another endoscopic intervention, such as balloon tamponade or surgery.
Over the period of study, a Poisson regression analysis used to control for multiple variables associated any TIPS utilization with an inverse association with overall mortality, producing a relative risk of 0.88 (95% confidence interval, 0.83-0.92). In the context of timing of TIPS, in-hospital mortality fell from 5.6% for those who received rescue TIPS to 1.5% in those who underwent early TIPS.
On multivariate analysis, an advantage was observed for early TIPS relative to rescue TIPS for in-hospital mortality (RR, 0.85; P less than .01), in-hospital rebleeding (RR, 0.57; P less than .01), and length of hospital stay (RR, 0.87; P less than .01). Rates of sepsis (RR, 0.83; P = .32) and hepatic encephalopathy (RR, 0.87; P = .22) were not significantly lower in the early TIPS group, but they were also not increased. For early TIPS versus no TIPS, the advantages on multivariate analysis were similar for both in-hospital deaths (RR, 0.87; P less than .01) and in-hospital rebleeding (RR, 0.57; P less than .01), but no advantage was seen for length of stay for TIPS versus no TIPS (RR, 0.99; P = .18).
Overall, there was a steady decline in mortality associated with esophageal variceal bleeding over the period of evaluation, falling incrementally over time from 656 deaths per 100,000 hospitalizations in 2000 to 412 deaths per 100,000 in 2010. This 37.2% reduction was statistically significant (P less than .01). The reduction in mortality was inversely associated with an increasing use of TIPS over the study period.
The data from this analysis are consistent with a multicenter randomized trial conducted several years ago in Europe (N Engl J Med. 2010;362:2370-9). In that study 63 patients with hepatic cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy were randomized to early TIPS or rescue TIPS. At 1 year, 86% of those in the early TIPS group were alive versus 61% (P = .01) of those randomized to receive TIPS as a rescue strategy.
Relative to the previous study, the key finding of this study is that early TIPS “is associated with significant short-term reductions in rebleeding and mortality without a significant increase in encephalopathy in real world U.S. clinical practice,” according to Dr. Njei. It substantiates the European study and encourages a protocol that emphasizes early TIPS, particularly in those with a high risk of repeat esophageal variceal bleeding.
In the discussion that followed the presentation of these results at the annual meeting of the American College of Gastroenterology, the moderator, Dr. Paul Y. Kwo, medical director of liver transplantation, Indiana University, Indianapolis, pointed out, that some of those in the rescue TIPS group might simply have been poor candidates for this intervention. Although he praised the methodology of this study, which won the 2015 ACG Fellows-In-Training Award, he questioned whether rescue TIPS was a last resort salvage therapy in those initially considered poor risks for TIPS. Dr. Njei responded that the multivariate analysis was specifically designed to control for variables such as risk status to diminish this potential bias. Indeed, he said he believes TIPS is underemployed.
“The relatively small percentage of eligible cases receiving early TIPS suggests that there is room for further improvement in the treatment of patients with decompensated cirrhosis and esophageal variceal bleeding,” Dr. Njei concluded.
Dr. Njei reported that he had no relevant financial relationships to disclose.
HONOLULU – Early use of a transjugular intrahepatic portosystemic shunt (TIPS) is associated with substantial reductions in mortality, according to an analysis of a national inpatient database.
Based on this study, “early use of TIPS, together with patient and physician education on current guidelines and protocols, should continue to be a priority to improve patient outcomes” in patients with hepatic cirrhosis and risk of recurrent esophageal variceal bleeds, reported Dr. Basile Njei, a gastroenterology fellow at Yale University, New Haven, Conn.
In this study, the Nationwide Inpatient Sample database was queried by ICD-9 codes to identify patients with esophageal variceal bleeding treated between the years 2000 and 2010. The goal was to compare early use of TIPS, defined as TIPS administered within 72 hours of the bleeding, relative to rescue TIPS, defined as TIPS after two or more episodes of bleeding or one bleeding episode followed by another endoscopic intervention, such as balloon tamponade or surgery.
Over the period of study, a Poisson regression analysis used to control for multiple variables associated any TIPS utilization with an inverse association with overall mortality, producing a relative risk of 0.88 (95% confidence interval, 0.83-0.92). In the context of timing of TIPS, in-hospital mortality fell from 5.6% for those who received rescue TIPS to 1.5% in those who underwent early TIPS.
On multivariate analysis, an advantage was observed for early TIPS relative to rescue TIPS for in-hospital mortality (RR, 0.85; P less than .01), in-hospital rebleeding (RR, 0.57; P less than .01), and length of hospital stay (RR, 0.87; P less than .01). Rates of sepsis (RR, 0.83; P = .32) and hepatic encephalopathy (RR, 0.87; P = .22) were not significantly lower in the early TIPS group, but they were also not increased. For early TIPS versus no TIPS, the advantages on multivariate analysis were similar for both in-hospital deaths (RR, 0.87; P less than .01) and in-hospital rebleeding (RR, 0.57; P less than .01), but no advantage was seen for length of stay for TIPS versus no TIPS (RR, 0.99; P = .18).
Overall, there was a steady decline in mortality associated with esophageal variceal bleeding over the period of evaluation, falling incrementally over time from 656 deaths per 100,000 hospitalizations in 2000 to 412 deaths per 100,000 in 2010. This 37.2% reduction was statistically significant (P less than .01). The reduction in mortality was inversely associated with an increasing use of TIPS over the study period.
The data from this analysis are consistent with a multicenter randomized trial conducted several years ago in Europe (N Engl J Med. 2010;362:2370-9). In that study 63 patients with hepatic cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy were randomized to early TIPS or rescue TIPS. At 1 year, 86% of those in the early TIPS group were alive versus 61% (P = .01) of those randomized to receive TIPS as a rescue strategy.
Relative to the previous study, the key finding of this study is that early TIPS “is associated with significant short-term reductions in rebleeding and mortality without a significant increase in encephalopathy in real world U.S. clinical practice,” according to Dr. Njei. It substantiates the European study and encourages a protocol that emphasizes early TIPS, particularly in those with a high risk of repeat esophageal variceal bleeding.
In the discussion that followed the presentation of these results at the annual meeting of the American College of Gastroenterology, the moderator, Dr. Paul Y. Kwo, medical director of liver transplantation, Indiana University, Indianapolis, pointed out, that some of those in the rescue TIPS group might simply have been poor candidates for this intervention. Although he praised the methodology of this study, which won the 2015 ACG Fellows-In-Training Award, he questioned whether rescue TIPS was a last resort salvage therapy in those initially considered poor risks for TIPS. Dr. Njei responded that the multivariate analysis was specifically designed to control for variables such as risk status to diminish this potential bias. Indeed, he said he believes TIPS is underemployed.
“The relatively small percentage of eligible cases receiving early TIPS suggests that there is room for further improvement in the treatment of patients with decompensated cirrhosis and esophageal variceal bleeding,” Dr. Njei concluded.
Dr. Njei reported that he had no relevant financial relationships to disclose.
HONOLULU – Early use of a transjugular intrahepatic portosystemic shunt (TIPS) is associated with substantial reductions in mortality, according to an analysis of a national inpatient database.
Based on this study, “early use of TIPS, together with patient and physician education on current guidelines and protocols, should continue to be a priority to improve patient outcomes” in patients with hepatic cirrhosis and risk of recurrent esophageal variceal bleeds, reported Dr. Basile Njei, a gastroenterology fellow at Yale University, New Haven, Conn.
In this study, the Nationwide Inpatient Sample database was queried by ICD-9 codes to identify patients with esophageal variceal bleeding treated between the years 2000 and 2010. The goal was to compare early use of TIPS, defined as TIPS administered within 72 hours of the bleeding, relative to rescue TIPS, defined as TIPS after two or more episodes of bleeding or one bleeding episode followed by another endoscopic intervention, such as balloon tamponade or surgery.
Over the period of study, a Poisson regression analysis used to control for multiple variables associated any TIPS utilization with an inverse association with overall mortality, producing a relative risk of 0.88 (95% confidence interval, 0.83-0.92). In the context of timing of TIPS, in-hospital mortality fell from 5.6% for those who received rescue TIPS to 1.5% in those who underwent early TIPS.
On multivariate analysis, an advantage was observed for early TIPS relative to rescue TIPS for in-hospital mortality (RR, 0.85; P less than .01), in-hospital rebleeding (RR, 0.57; P less than .01), and length of hospital stay (RR, 0.87; P less than .01). Rates of sepsis (RR, 0.83; P = .32) and hepatic encephalopathy (RR, 0.87; P = .22) were not significantly lower in the early TIPS group, but they were also not increased. For early TIPS versus no TIPS, the advantages on multivariate analysis were similar for both in-hospital deaths (RR, 0.87; P less than .01) and in-hospital rebleeding (RR, 0.57; P less than .01), but no advantage was seen for length of stay for TIPS versus no TIPS (RR, 0.99; P = .18).
Overall, there was a steady decline in mortality associated with esophageal variceal bleeding over the period of evaluation, falling incrementally over time from 656 deaths per 100,000 hospitalizations in 2000 to 412 deaths per 100,000 in 2010. This 37.2% reduction was statistically significant (P less than .01). The reduction in mortality was inversely associated with an increasing use of TIPS over the study period.
The data from this analysis are consistent with a multicenter randomized trial conducted several years ago in Europe (N Engl J Med. 2010;362:2370-9). In that study 63 patients with hepatic cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy were randomized to early TIPS or rescue TIPS. At 1 year, 86% of those in the early TIPS group were alive versus 61% (P = .01) of those randomized to receive TIPS as a rescue strategy.
Relative to the previous study, the key finding of this study is that early TIPS “is associated with significant short-term reductions in rebleeding and mortality without a significant increase in encephalopathy in real world U.S. clinical practice,” according to Dr. Njei. It substantiates the European study and encourages a protocol that emphasizes early TIPS, particularly in those with a high risk of repeat esophageal variceal bleeding.
In the discussion that followed the presentation of these results at the annual meeting of the American College of Gastroenterology, the moderator, Dr. Paul Y. Kwo, medical director of liver transplantation, Indiana University, Indianapolis, pointed out, that some of those in the rescue TIPS group might simply have been poor candidates for this intervention. Although he praised the methodology of this study, which won the 2015 ACG Fellows-In-Training Award, he questioned whether rescue TIPS was a last resort salvage therapy in those initially considered poor risks for TIPS. Dr. Njei responded that the multivariate analysis was specifically designed to control for variables such as risk status to diminish this potential bias. Indeed, he said he believes TIPS is underemployed.
“The relatively small percentage of eligible cases receiving early TIPS suggests that there is room for further improvement in the treatment of patients with decompensated cirrhosis and esophageal variceal bleeding,” Dr. Njei concluded.
Dr. Njei reported that he had no relevant financial relationships to disclose.
AT ACG 2015
Key clinical point:Early use of a transjugular intrahepatic portosystemic shunt to reduce the risk of esophageal variceal rebleeding is associated with reduced mortality.
Major finding: In those receiving early TIPS (TIPS administered within 72 hours of the bleeding) mortality was 1.5% vs. 5.6% for those receiving TIPS as rescue therapy.
Data source: A retrospective evaluation of a national inpatient database.
Disclosures: Dr. Njei reported that he had no relevant financial relationships to disclose.
Healthcare.gov: Premiums to jump in 8 states
Patients in eight states could be in for a big surprise when they reenroll for health insurance coverage through the federal marketplace.
The Health & Human Services department announced Oct. 26 that residents in Oklahoma, Montana, Alaska, New Mexico, South Dakota, North Carolina, Oregon, and Tennessee will see at least a 20% rise in premiums for benchmark plans. Leading the way is Oklahoma with a 35.7% increase, followed by Montana (34.5%) and Alaska (31.5%).
Open enrollment for 2016 begins on Nov. 1.
Four states will see a decline in benchmark premium rates, the largest occurring in Indiana (–12.6%), followed by Mississippi (–8.2%), Maine (–1.2%), and Ohio (–0.7%).
Across the 37 states in the federal marketplace, premiums for benchmark plan will increase on average 7.5%. In 2015, there were 8.8 million people enrolled in benchmark plans.
HHS also reported that next year, nearly 8 in 10 returning patients will be able to buy a plan with premiums less than $100 after tax credits, while 7 in 10 will be able to spend $75 or less after tax credits.
Patients in more than two-thirds of counties covered by the federal marketplace will be able to choose from three or more plans. HHS also noted that in the second open enrollment period (2015), those who switched plans within the same tier saved an average of nearly $400 on their annualized premiums after tax credits, compared with those who did not switch.
Patients in eight states could be in for a big surprise when they reenroll for health insurance coverage through the federal marketplace.
The Health & Human Services department announced Oct. 26 that residents in Oklahoma, Montana, Alaska, New Mexico, South Dakota, North Carolina, Oregon, and Tennessee will see at least a 20% rise in premiums for benchmark plans. Leading the way is Oklahoma with a 35.7% increase, followed by Montana (34.5%) and Alaska (31.5%).
Open enrollment for 2016 begins on Nov. 1.
Four states will see a decline in benchmark premium rates, the largest occurring in Indiana (–12.6%), followed by Mississippi (–8.2%), Maine (–1.2%), and Ohio (–0.7%).
Across the 37 states in the federal marketplace, premiums for benchmark plan will increase on average 7.5%. In 2015, there were 8.8 million people enrolled in benchmark plans.
HHS also reported that next year, nearly 8 in 10 returning patients will be able to buy a plan with premiums less than $100 after tax credits, while 7 in 10 will be able to spend $75 or less after tax credits.
Patients in more than two-thirds of counties covered by the federal marketplace will be able to choose from three or more plans. HHS also noted that in the second open enrollment period (2015), those who switched plans within the same tier saved an average of nearly $400 on their annualized premiums after tax credits, compared with those who did not switch.
Patients in eight states could be in for a big surprise when they reenroll for health insurance coverage through the federal marketplace.
The Health & Human Services department announced Oct. 26 that residents in Oklahoma, Montana, Alaska, New Mexico, South Dakota, North Carolina, Oregon, and Tennessee will see at least a 20% rise in premiums for benchmark plans. Leading the way is Oklahoma with a 35.7% increase, followed by Montana (34.5%) and Alaska (31.5%).
Open enrollment for 2016 begins on Nov. 1.
Four states will see a decline in benchmark premium rates, the largest occurring in Indiana (–12.6%), followed by Mississippi (–8.2%), Maine (–1.2%), and Ohio (–0.7%).
Across the 37 states in the federal marketplace, premiums for benchmark plan will increase on average 7.5%. In 2015, there were 8.8 million people enrolled in benchmark plans.
HHS also reported that next year, nearly 8 in 10 returning patients will be able to buy a plan with premiums less than $100 after tax credits, while 7 in 10 will be able to spend $75 or less after tax credits.
Patients in more than two-thirds of counties covered by the federal marketplace will be able to choose from three or more plans. HHS also noted that in the second open enrollment period (2015), those who switched plans within the same tier saved an average of nearly $400 on their annualized premiums after tax credits, compared with those who did not switch.
ACA insurance networks lack specialist coverage
Nearly 15% of insurance plans for sale via healthcare.gov lack in-network physicians for at least one specialty, according to an analysis published Oct. 27 in JAMA. Endocrinologists, rheumatologists, and psychiatrists were most commonly excluded.
Stephen C. Dorner of Harvard T. H. Chan School of Public Health, Boston, and his colleagues examined physician networks in 34 states offering plans through the federal marketplace (healthcare.gov) during 2015 open enrollment. They searched plans’ online directories for in-network specialists in obstetrics/gynecology, dermatology, cardiology, psychiatry, oncology, neurology, endocrinology, rheumatology, and pulmonology. Searches were done for specialists within both 50 and 100 miles.
Of the 135 plans, 18 (13%) were specialist deficient in the 100-mile search, while 19 (14%) of plans lacked in-network specialists in the 50-mile search (JAMA. 2015;16:1749-50. doi. 101001/jama.2015.9375).
Patients in specialist-deficient plans had high out-of-network costs, Mr. Dorner and colleagues found. Of the 19 specialist-deficient plans, 5 did not cover out-of-network services, whereas 11 of the remaining 14 plans required cost-sharing of 50% or more. Nine of the 19 inadequate plans did not cover medications prescribed by out-of-network physicians.
The findings raise concerns about patient access to specialty care and suggest that a number of plans are violating network adequacy requirements, Mr. Dorner said, adding that such inadequate plans precipitate high out-of-pocket costs and may lead to adverse plan selection.
On Twitter @legal_med
Nearly 15% of insurance plans for sale via healthcare.gov lack in-network physicians for at least one specialty, according to an analysis published Oct. 27 in JAMA. Endocrinologists, rheumatologists, and psychiatrists were most commonly excluded.
Stephen C. Dorner of Harvard T. H. Chan School of Public Health, Boston, and his colleagues examined physician networks in 34 states offering plans through the federal marketplace (healthcare.gov) during 2015 open enrollment. They searched plans’ online directories for in-network specialists in obstetrics/gynecology, dermatology, cardiology, psychiatry, oncology, neurology, endocrinology, rheumatology, and pulmonology. Searches were done for specialists within both 50 and 100 miles.
Of the 135 plans, 18 (13%) were specialist deficient in the 100-mile search, while 19 (14%) of plans lacked in-network specialists in the 50-mile search (JAMA. 2015;16:1749-50. doi. 101001/jama.2015.9375).
Patients in specialist-deficient plans had high out-of-network costs, Mr. Dorner and colleagues found. Of the 19 specialist-deficient plans, 5 did not cover out-of-network services, whereas 11 of the remaining 14 plans required cost-sharing of 50% or more. Nine of the 19 inadequate plans did not cover medications prescribed by out-of-network physicians.
The findings raise concerns about patient access to specialty care and suggest that a number of plans are violating network adequacy requirements, Mr. Dorner said, adding that such inadequate plans precipitate high out-of-pocket costs and may lead to adverse plan selection.
On Twitter @legal_med
Nearly 15% of insurance plans for sale via healthcare.gov lack in-network physicians for at least one specialty, according to an analysis published Oct. 27 in JAMA. Endocrinologists, rheumatologists, and psychiatrists were most commonly excluded.
Stephen C. Dorner of Harvard T. H. Chan School of Public Health, Boston, and his colleagues examined physician networks in 34 states offering plans through the federal marketplace (healthcare.gov) during 2015 open enrollment. They searched plans’ online directories for in-network specialists in obstetrics/gynecology, dermatology, cardiology, psychiatry, oncology, neurology, endocrinology, rheumatology, and pulmonology. Searches were done for specialists within both 50 and 100 miles.
Of the 135 plans, 18 (13%) were specialist deficient in the 100-mile search, while 19 (14%) of plans lacked in-network specialists in the 50-mile search (JAMA. 2015;16:1749-50. doi. 101001/jama.2015.9375).
Patients in specialist-deficient plans had high out-of-network costs, Mr. Dorner and colleagues found. Of the 19 specialist-deficient plans, 5 did not cover out-of-network services, whereas 11 of the remaining 14 plans required cost-sharing of 50% or more. Nine of the 19 inadequate plans did not cover medications prescribed by out-of-network physicians.
The findings raise concerns about patient access to specialty care and suggest that a number of plans are violating network adequacy requirements, Mr. Dorner said, adding that such inadequate plans precipitate high out-of-pocket costs and may lead to adverse plan selection.
On Twitter @legal_med
FROM JAMA
Key clinical point: Many patients who buy insurance via healthcare.gov are not getting access to specialists’ care.
Major finding: In a study of 135 federal marketplace insurance plans, nearly 15% lacked in-network physicians for at least one specialty. Of 34 states, 9 had at least one specialist-deficient plan.
Data source: Review of physician networks listed on insurance plans for sale via healthcare.gov in April 2015.
Disclosures: No relevant financial disclosures were reported.
ACS: No pull-out pneumothorax with ‘party balloon Valsalva’
CHICAGO – Investigators have come up with a simple way to reduce and maybe even eliminate pull-out pneumothoraces during chest tube removal.
Instead of standard inhale or exhale Valsalva maneuvers, they have their patients blow up a party balloon as the tube is pulled.
That produces the same Valsalva effects as the standard maneuvers, but with two significant advantages. First, it’s easy to explain and for patients to understand and do – not much more instruction is required than “blow up the balloon” – and, secondly, the inflating balloon is a visual check to make sure patients are doing the maneuver correctly. “It’s easy. Everyone can do it,” said lead investigator Dr. Puwadon Thitivaraporn, who developed the technique with Dr. Kritaya Kritayakirana and colleagues at King Chulalongkorn Memorial Hospital in Bangkok, Thailand.
To see how well it works, the team randomized 10 women and 38 men about equally to four removal techniques: the standard expire Valsalva, the standard inspire Valsalva, and two balloon maneuvers – blowing the balloon up after a deep breath and blowing it up with residual lung volume after an initial exhalation.
The subjects were trauma patients 15-64 years old, with a mean age of 38 years. Lung injuries, rib fractures, and tube suction were a bit more common in the standard maneuver groups. Patients with tracheotomies, chronic lung disease, and Glasgow Coma Scores below 13 were excluded from the study. Hemopneumothorax was the most common indication for tube placement.
Two patients in each of the standard groups (16%) developed a pull-out pneumothorax within 24 hours of tube removal, confirmed by x-ray. One required chest tube reinsertion, and all four ended up spending extra time in the hospital. Similar problems have been reported in American medicine (J Trauma. 2001 Apr;50[4]:674-7).
Meanwhile, not a single balloon patient had a lung collapse when their tube was pulled.
Because of the small number of subjects, the differences weren’t statistically significant, but they came close in a group comparison of standard patients with balloon patients (P = .11). The investigators estimated they would need almost 600 hundred subjects to reach statistical significance.
Even so, the party balloon technique appears to be “easier and safer” than standard maneuvers, as well as “reproducible and cheap, and it can prevent recurrent pneumothorax. It can be used as an alternative to the classic Valsalva,” said Dr. Thitivaraporn, a cardiothoracic surgery resident at the Bangkok hospital.
The balloon method is being used there now in nontrauma patients, as well, but the standard maneuvers are also being used until the balloon technique shows statistically significant benefits, he said.
With manometry, the team found that a party balloon’s internal pressure builds quickly as it’s inflated from a starting diameter of about 4.5 cm to about 9 cm, peaking at about 60 mm Hg; pressure trails off to about 40 mm Hg as inflation continues past 9 cm.
The investigators have no relevant disclosures.
CHICAGO – Investigators have come up with a simple way to reduce and maybe even eliminate pull-out pneumothoraces during chest tube removal.
Instead of standard inhale or exhale Valsalva maneuvers, they have their patients blow up a party balloon as the tube is pulled.
That produces the same Valsalva effects as the standard maneuvers, but with two significant advantages. First, it’s easy to explain and for patients to understand and do – not much more instruction is required than “blow up the balloon” – and, secondly, the inflating balloon is a visual check to make sure patients are doing the maneuver correctly. “It’s easy. Everyone can do it,” said lead investigator Dr. Puwadon Thitivaraporn, who developed the technique with Dr. Kritaya Kritayakirana and colleagues at King Chulalongkorn Memorial Hospital in Bangkok, Thailand.
To see how well it works, the team randomized 10 women and 38 men about equally to four removal techniques: the standard expire Valsalva, the standard inspire Valsalva, and two balloon maneuvers – blowing the balloon up after a deep breath and blowing it up with residual lung volume after an initial exhalation.
The subjects were trauma patients 15-64 years old, with a mean age of 38 years. Lung injuries, rib fractures, and tube suction were a bit more common in the standard maneuver groups. Patients with tracheotomies, chronic lung disease, and Glasgow Coma Scores below 13 were excluded from the study. Hemopneumothorax was the most common indication for tube placement.
Two patients in each of the standard groups (16%) developed a pull-out pneumothorax within 24 hours of tube removal, confirmed by x-ray. One required chest tube reinsertion, and all four ended up spending extra time in the hospital. Similar problems have been reported in American medicine (J Trauma. 2001 Apr;50[4]:674-7).
Meanwhile, not a single balloon patient had a lung collapse when their tube was pulled.
Because of the small number of subjects, the differences weren’t statistically significant, but they came close in a group comparison of standard patients with balloon patients (P = .11). The investigators estimated they would need almost 600 hundred subjects to reach statistical significance.
Even so, the party balloon technique appears to be “easier and safer” than standard maneuvers, as well as “reproducible and cheap, and it can prevent recurrent pneumothorax. It can be used as an alternative to the classic Valsalva,” said Dr. Thitivaraporn, a cardiothoracic surgery resident at the Bangkok hospital.
The balloon method is being used there now in nontrauma patients, as well, but the standard maneuvers are also being used until the balloon technique shows statistically significant benefits, he said.
With manometry, the team found that a party balloon’s internal pressure builds quickly as it’s inflated from a starting diameter of about 4.5 cm to about 9 cm, peaking at about 60 mm Hg; pressure trails off to about 40 mm Hg as inflation continues past 9 cm.
The investigators have no relevant disclosures.
CHICAGO – Investigators have come up with a simple way to reduce and maybe even eliminate pull-out pneumothoraces during chest tube removal.
Instead of standard inhale or exhale Valsalva maneuvers, they have their patients blow up a party balloon as the tube is pulled.
That produces the same Valsalva effects as the standard maneuvers, but with two significant advantages. First, it’s easy to explain and for patients to understand and do – not much more instruction is required than “blow up the balloon” – and, secondly, the inflating balloon is a visual check to make sure patients are doing the maneuver correctly. “It’s easy. Everyone can do it,” said lead investigator Dr. Puwadon Thitivaraporn, who developed the technique with Dr. Kritaya Kritayakirana and colleagues at King Chulalongkorn Memorial Hospital in Bangkok, Thailand.
To see how well it works, the team randomized 10 women and 38 men about equally to four removal techniques: the standard expire Valsalva, the standard inspire Valsalva, and two balloon maneuvers – blowing the balloon up after a deep breath and blowing it up with residual lung volume after an initial exhalation.
The subjects were trauma patients 15-64 years old, with a mean age of 38 years. Lung injuries, rib fractures, and tube suction were a bit more common in the standard maneuver groups. Patients with tracheotomies, chronic lung disease, and Glasgow Coma Scores below 13 were excluded from the study. Hemopneumothorax was the most common indication for tube placement.
Two patients in each of the standard groups (16%) developed a pull-out pneumothorax within 24 hours of tube removal, confirmed by x-ray. One required chest tube reinsertion, and all four ended up spending extra time in the hospital. Similar problems have been reported in American medicine (J Trauma. 2001 Apr;50[4]:674-7).
Meanwhile, not a single balloon patient had a lung collapse when their tube was pulled.
Because of the small number of subjects, the differences weren’t statistically significant, but they came close in a group comparison of standard patients with balloon patients (P = .11). The investigators estimated they would need almost 600 hundred subjects to reach statistical significance.
Even so, the party balloon technique appears to be “easier and safer” than standard maneuvers, as well as “reproducible and cheap, and it can prevent recurrent pneumothorax. It can be used as an alternative to the classic Valsalva,” said Dr. Thitivaraporn, a cardiothoracic surgery resident at the Bangkok hospital.
The balloon method is being used there now in nontrauma patients, as well, but the standard maneuvers are also being used until the balloon technique shows statistically significant benefits, he said.
With manometry, the team found that a party balloon’s internal pressure builds quickly as it’s inflated from a starting diameter of about 4.5 cm to about 9 cm, peaking at about 60 mm Hg; pressure trails off to about 40 mm Hg as inflation continues past 9 cm.
The investigators have no relevant disclosures.
AT THE ACS CLINICAL CONGRESS
Key clinical point: The next time you pull a chest tube, you might want to ask your patient to blow up a balloon.
Major finding: Sixteen percent of patients collapsed a lung with classic inhale/exhale Valsalva maneuvers during chest tube removal, but none did with the balloon technique.
Data source: Randomized, controlled trial of 48 chest tube patients.
Disclosures: The investigators have no relevant disclosures.
