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Mitchel is a reporter for MDedge based in the Philadelphia area. He started with the company in 1992, when it was International Medical News Group (IMNG), and has since covered a range of medical specialties. Mitchel trained as a virologist at Roswell Park Memorial Institute in Buffalo, and then worked briefly as a researcher at Boston Children's Hospital before pivoting to journalism as a AAAS Mass Media Fellow in 1980. His first reporting job was with Science Digest magazine, and from the mid-1980s to early-1990s he was a reporter with Medical World News. @mitchelzoler
PCI advances produce CABG-like 1-year outcomes
BARCELONA – Improvements in percutaneous coronary intervention over the past decade have made a difference. Coronary stenting to treat triple-vessel disease produced roughly the same 1-year results as coronary artery bypass surgery, based on results from 454 patients in an uncontrolled, prospective trial.
With state-of-the-art percutaneous coronary intervention (PCI), the 1-year incidence of major cardiac and cerebrovascular events was 11% in the Synergy Between PCI with Taxus and Cardiac Surgery (SYNTAX) II trial, a PCI outcome substantially better than the 18% rate with PCI seen in the original SYNTAX trial, run during 2005-2007. That incidence was similar to the 11% 1-year major adverse event rate seen in patients who underwent coronary artery bypass grafting (CABG) in the first SYNTAX trial (N Engl J Med. 2009 Mar 5;360[10]:961-72), said Javier Escaned, MD, who reported the results at the annual congress of the European Society of Cardiology.
- Initial assessment of patients using both clinical and anatomic criteria with the SYNTAX score II (Lancet. 2013 Feb 23;381[9867]:639-50), an improvement over the original SYNTAX score that only used anatomic data.
- Assessment of each coronary stenosis for its physiologic impact using a pressure wire to measure the instantaneous wave-free ratio and fractional flow reserve of each suspicious lesion.
- Performing PCI with a second-generation everolimus-eluting stent with a bioabsorbable polymer stent (Synergy) instead of the paclitaxel-eluting first-generation stent (Taxus) used in the first SYNTAX trial.
- Optimization of stent placement with intravascular ultrasound.
- Application of contemporary methods for treating total chronic occlusions that produce higher success rates than a decade ago.
- Prescription of current guideline-directed medical therapy to each patient following PCI.
“To get the best results you need to do all of this; none of these steps takes full credit by itself,” said Dr. Escaned, an interventional cardiologist at the Hospital Clinic San Carlos in Madrid. “The message from SYNTAX II is that if you put all of these steps together, this is the result,” he said in an interview.
An underlying assumption of the single-arm design of SYNTAX II and its “exploratory” comparison to a 334-patient subset of the 897 patients who underwent CABG in the original SYNTAX trial who retrospectively met the SYNTAX score II enrollment criteria used in the current trial was that “CABG has not changed much” since the first SYNTAX trial, Dr. Escaned said. Although he acknowledged that some progress also occurred with CABG in the subsequent 10 years, “it has not been as big a change” as going to second-generation drug-eluting stents, using a pressure wire assessment to target physiologically important stenoses, and improved techniques for treating chronic total occlusions that have nearly doubled success rates in patients with these lesions.
The SYNTAX II trial enrolled 454 patients with de novo triple-vessel coronary disease without left main stem involvement at 22 centers in four European countries during 2014 and 2015. The improvement in the primary 1-year endpoint in the current patients compared with PCI patients from the first SYNTAX trial was driven primarily by reductions in MI and in repeat revascularizations. The SYNTAX II patients also had a 0.7% rate of definite stent thrombosis events, compared with a 2.4% rate in the original SYNTAX PCI patients, a statistically significant difference. Concurrently with Dr. Escaned’s report at the meeting an article with the results appeared online (Eur Heart J. 2017 Aug 26;doi: 10.1093/eurheartj/ehx512).
Dr. Escaned cautioned that longer-term follow-up is needed to more fully compare the PCI results with CABG.
SYNTAX II received unrestricted grant support from Philips/Volcano and Boston Scientific, the companies that market the pressure wires and stents used in the study. Dr. Escaned reported ties to Abbott, AstraZeneca, Biosensors, Boston Scientific, Medtronic, OrbusNeich, Philips/Volcano, and Boston Scientific.
[email protected]
On Twitter @mitchelzoler
BARCELONA – Improvements in percutaneous coronary intervention over the past decade have made a difference. Coronary stenting to treat triple-vessel disease produced roughly the same 1-year results as coronary artery bypass surgery, based on results from 454 patients in an uncontrolled, prospective trial.
With state-of-the-art percutaneous coronary intervention (PCI), the 1-year incidence of major cardiac and cerebrovascular events was 11% in the Synergy Between PCI with Taxus and Cardiac Surgery (SYNTAX) II trial, a PCI outcome substantially better than the 18% rate with PCI seen in the original SYNTAX trial, run during 2005-2007. That incidence was similar to the 11% 1-year major adverse event rate seen in patients who underwent coronary artery bypass grafting (CABG) in the first SYNTAX trial (N Engl J Med. 2009 Mar 5;360[10]:961-72), said Javier Escaned, MD, who reported the results at the annual congress of the European Society of Cardiology.
- Initial assessment of patients using both clinical and anatomic criteria with the SYNTAX score II (Lancet. 2013 Feb 23;381[9867]:639-50), an improvement over the original SYNTAX score that only used anatomic data.
- Assessment of each coronary stenosis for its physiologic impact using a pressure wire to measure the instantaneous wave-free ratio and fractional flow reserve of each suspicious lesion.
- Performing PCI with a second-generation everolimus-eluting stent with a bioabsorbable polymer stent (Synergy) instead of the paclitaxel-eluting first-generation stent (Taxus) used in the first SYNTAX trial.
- Optimization of stent placement with intravascular ultrasound.
- Application of contemporary methods for treating total chronic occlusions that produce higher success rates than a decade ago.
- Prescription of current guideline-directed medical therapy to each patient following PCI.
“To get the best results you need to do all of this; none of these steps takes full credit by itself,” said Dr. Escaned, an interventional cardiologist at the Hospital Clinic San Carlos in Madrid. “The message from SYNTAX II is that if you put all of these steps together, this is the result,” he said in an interview.
An underlying assumption of the single-arm design of SYNTAX II and its “exploratory” comparison to a 334-patient subset of the 897 patients who underwent CABG in the original SYNTAX trial who retrospectively met the SYNTAX score II enrollment criteria used in the current trial was that “CABG has not changed much” since the first SYNTAX trial, Dr. Escaned said. Although he acknowledged that some progress also occurred with CABG in the subsequent 10 years, “it has not been as big a change” as going to second-generation drug-eluting stents, using a pressure wire assessment to target physiologically important stenoses, and improved techniques for treating chronic total occlusions that have nearly doubled success rates in patients with these lesions.
The SYNTAX II trial enrolled 454 patients with de novo triple-vessel coronary disease without left main stem involvement at 22 centers in four European countries during 2014 and 2015. The improvement in the primary 1-year endpoint in the current patients compared with PCI patients from the first SYNTAX trial was driven primarily by reductions in MI and in repeat revascularizations. The SYNTAX II patients also had a 0.7% rate of definite stent thrombosis events, compared with a 2.4% rate in the original SYNTAX PCI patients, a statistically significant difference. Concurrently with Dr. Escaned’s report at the meeting an article with the results appeared online (Eur Heart J. 2017 Aug 26;doi: 10.1093/eurheartj/ehx512).
Dr. Escaned cautioned that longer-term follow-up is needed to more fully compare the PCI results with CABG.
SYNTAX II received unrestricted grant support from Philips/Volcano and Boston Scientific, the companies that market the pressure wires and stents used in the study. Dr. Escaned reported ties to Abbott, AstraZeneca, Biosensors, Boston Scientific, Medtronic, OrbusNeich, Philips/Volcano, and Boston Scientific.
[email protected]
On Twitter @mitchelzoler
BARCELONA – Improvements in percutaneous coronary intervention over the past decade have made a difference. Coronary stenting to treat triple-vessel disease produced roughly the same 1-year results as coronary artery bypass surgery, based on results from 454 patients in an uncontrolled, prospective trial.
With state-of-the-art percutaneous coronary intervention (PCI), the 1-year incidence of major cardiac and cerebrovascular events was 11% in the Synergy Between PCI with Taxus and Cardiac Surgery (SYNTAX) II trial, a PCI outcome substantially better than the 18% rate with PCI seen in the original SYNTAX trial, run during 2005-2007. That incidence was similar to the 11% 1-year major adverse event rate seen in patients who underwent coronary artery bypass grafting (CABG) in the first SYNTAX trial (N Engl J Med. 2009 Mar 5;360[10]:961-72), said Javier Escaned, MD, who reported the results at the annual congress of the European Society of Cardiology.
- Initial assessment of patients using both clinical and anatomic criteria with the SYNTAX score II (Lancet. 2013 Feb 23;381[9867]:639-50), an improvement over the original SYNTAX score that only used anatomic data.
- Assessment of each coronary stenosis for its physiologic impact using a pressure wire to measure the instantaneous wave-free ratio and fractional flow reserve of each suspicious lesion.
- Performing PCI with a second-generation everolimus-eluting stent with a bioabsorbable polymer stent (Synergy) instead of the paclitaxel-eluting first-generation stent (Taxus) used in the first SYNTAX trial.
- Optimization of stent placement with intravascular ultrasound.
- Application of contemporary methods for treating total chronic occlusions that produce higher success rates than a decade ago.
- Prescription of current guideline-directed medical therapy to each patient following PCI.
“To get the best results you need to do all of this; none of these steps takes full credit by itself,” said Dr. Escaned, an interventional cardiologist at the Hospital Clinic San Carlos in Madrid. “The message from SYNTAX II is that if you put all of these steps together, this is the result,” he said in an interview.
An underlying assumption of the single-arm design of SYNTAX II and its “exploratory” comparison to a 334-patient subset of the 897 patients who underwent CABG in the original SYNTAX trial who retrospectively met the SYNTAX score II enrollment criteria used in the current trial was that “CABG has not changed much” since the first SYNTAX trial, Dr. Escaned said. Although he acknowledged that some progress also occurred with CABG in the subsequent 10 years, “it has not been as big a change” as going to second-generation drug-eluting stents, using a pressure wire assessment to target physiologically important stenoses, and improved techniques for treating chronic total occlusions that have nearly doubled success rates in patients with these lesions.
The SYNTAX II trial enrolled 454 patients with de novo triple-vessel coronary disease without left main stem involvement at 22 centers in four European countries during 2014 and 2015. The improvement in the primary 1-year endpoint in the current patients compared with PCI patients from the first SYNTAX trial was driven primarily by reductions in MI and in repeat revascularizations. The SYNTAX II patients also had a 0.7% rate of definite stent thrombosis events, compared with a 2.4% rate in the original SYNTAX PCI patients, a statistically significant difference. Concurrently with Dr. Escaned’s report at the meeting an article with the results appeared online (Eur Heart J. 2017 Aug 26;doi: 10.1093/eurheartj/ehx512).
Dr. Escaned cautioned that longer-term follow-up is needed to more fully compare the PCI results with CABG.
SYNTAX II received unrestricted grant support from Philips/Volcano and Boston Scientific, the companies that market the pressure wires and stents used in the study. Dr. Escaned reported ties to Abbott, AstraZeneca, Biosensors, Boston Scientific, Medtronic, OrbusNeich, Philips/Volcano, and Boston Scientific.
[email protected]
On Twitter @mitchelzoler
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: At 1 year, the combined major adverse event rate was 11%, similar to the CABG rate in the original SYNTAX trial.
Data source: SYNTAX II, a prospective, multicenter, single-arm study with 454 patients.
Disclosures: SYNTAX II received unrestricted grant support from Philips/Volcano and Boston Scientific, the companies that market the pressure wires and stents used in the study. Dr. Escaned reported ties to Abbott, AstraZeneca, Biosensors, Boston Scientific, Medtronic, OrbusNeich, Philips/Volcano, and Boston Scientific.
VIDEO: Celiac disease runs ninefold higher in eosinophilic esophagitis
ORLANDO – Patients with eosinophilic esophagitis had a ninefold increased prevalence of celiac disease, compared with the general public, in a review of more than 35 million U.S. residents.
This finding, which corresponded to a 2% overall prevalence rate of celiac disease in patients diagnosed with eosinophilic esophagitis, suggests that routine screening for celiac disease in eosinophilic esophagitis patients is warranted, Emad Mansoor, MD, said at the World Congress of Gastroenterology at ACG 2017.
This high prevalence level “has great implications for how we screen, treat, and manage” patients with either disorder, Dr. Mansoor said in a video interview. He hypothesized that celiac disease and eosinophilic esophagitis could share genetic etiologies or environmental or autoimmune triggers that produce the high level of overlap that the results showed.
The same analysis also found high rates of celiac disease in patients with either eosinophilic gastroenteritis or colitis, but because these are both much less prevalent than eosiniphillic esophagitis the absolute number of patients with either of these eosinophilic disorders who also had celiac disease was much lower.
It’s very possible that the prevalence of eosinophilic esophagitis among patients with celiac disease is also significantly elevated, compared with the general population, but he and his associates have not run this analysis.
Their study included diagnostic records for 35,795,250 people in the Explorys database during May 2012 to May 2017, with entries from 317,000 providers at 360 U.S. hospitals. The review identified 84,040 patients with a diagnosis of celiac disease, 15,360 with eosinophilic esophagitis, 1,440 with eosinophilic gastritis, and 800 with eosinophilic colitis. This worked out to a 5-year prevalence rate of 234.8 cases of celiac disease per 100,000 patients (0.235%), an eosinophilic esophagitis prevalence of 43.7 per 100,000, an eosinophilic gastroenteritis rate of 4.0 per 100,000, and an eosinophilic colitis rate of 2.2 per 100,000, said Dr. Mansoor, a gastroenterologist at University Hospitals Cleveland Medical Center.
The prevalence of celiac disease among patients with eosinophilic gastroenteritis or colitis was higher than in the eosinophilic esophagitis patients, with rates of 3.5% and 3.7%, respectively, that translated into odds ratios about 16-fold higher than the prevalence rates in the general population for both of these eosionophilic disorders.
The analyses reported by Dr. Mansoor also showed that the prevalence of celiac disease among patients with eosinophilic esophagitis was nearly twice as high in children (not more than 18 years old) as in adults and 50% higher in women than in men. These age and sex differences were both statistically significant.
Dr. Mansoor had no disclosures.
[email protected]
On Twitter @mitchelzoler
ORLANDO – Patients with eosinophilic esophagitis had a ninefold increased prevalence of celiac disease, compared with the general public, in a review of more than 35 million U.S. residents.
This finding, which corresponded to a 2% overall prevalence rate of celiac disease in patients diagnosed with eosinophilic esophagitis, suggests that routine screening for celiac disease in eosinophilic esophagitis patients is warranted, Emad Mansoor, MD, said at the World Congress of Gastroenterology at ACG 2017.
This high prevalence level “has great implications for how we screen, treat, and manage” patients with either disorder, Dr. Mansoor said in a video interview. He hypothesized that celiac disease and eosinophilic esophagitis could share genetic etiologies or environmental or autoimmune triggers that produce the high level of overlap that the results showed.
The same analysis also found high rates of celiac disease in patients with either eosinophilic gastroenteritis or colitis, but because these are both much less prevalent than eosiniphillic esophagitis the absolute number of patients with either of these eosinophilic disorders who also had celiac disease was much lower.
It’s very possible that the prevalence of eosinophilic esophagitis among patients with celiac disease is also significantly elevated, compared with the general population, but he and his associates have not run this analysis.
Their study included diagnostic records for 35,795,250 people in the Explorys database during May 2012 to May 2017, with entries from 317,000 providers at 360 U.S. hospitals. The review identified 84,040 patients with a diagnosis of celiac disease, 15,360 with eosinophilic esophagitis, 1,440 with eosinophilic gastritis, and 800 with eosinophilic colitis. This worked out to a 5-year prevalence rate of 234.8 cases of celiac disease per 100,000 patients (0.235%), an eosinophilic esophagitis prevalence of 43.7 per 100,000, an eosinophilic gastroenteritis rate of 4.0 per 100,000, and an eosinophilic colitis rate of 2.2 per 100,000, said Dr. Mansoor, a gastroenterologist at University Hospitals Cleveland Medical Center.
The prevalence of celiac disease among patients with eosinophilic gastroenteritis or colitis was higher than in the eosinophilic esophagitis patients, with rates of 3.5% and 3.7%, respectively, that translated into odds ratios about 16-fold higher than the prevalence rates in the general population for both of these eosionophilic disorders.
The analyses reported by Dr. Mansoor also showed that the prevalence of celiac disease among patients with eosinophilic esophagitis was nearly twice as high in children (not more than 18 years old) as in adults and 50% higher in women than in men. These age and sex differences were both statistically significant.
Dr. Mansoor had no disclosures.
[email protected]
On Twitter @mitchelzoler
ORLANDO – Patients with eosinophilic esophagitis had a ninefold increased prevalence of celiac disease, compared with the general public, in a review of more than 35 million U.S. residents.
This finding, which corresponded to a 2% overall prevalence rate of celiac disease in patients diagnosed with eosinophilic esophagitis, suggests that routine screening for celiac disease in eosinophilic esophagitis patients is warranted, Emad Mansoor, MD, said at the World Congress of Gastroenterology at ACG 2017.
This high prevalence level “has great implications for how we screen, treat, and manage” patients with either disorder, Dr. Mansoor said in a video interview. He hypothesized that celiac disease and eosinophilic esophagitis could share genetic etiologies or environmental or autoimmune triggers that produce the high level of overlap that the results showed.
The same analysis also found high rates of celiac disease in patients with either eosinophilic gastroenteritis or colitis, but because these are both much less prevalent than eosiniphillic esophagitis the absolute number of patients with either of these eosinophilic disorders who also had celiac disease was much lower.
It’s very possible that the prevalence of eosinophilic esophagitis among patients with celiac disease is also significantly elevated, compared with the general population, but he and his associates have not run this analysis.
Their study included diagnostic records for 35,795,250 people in the Explorys database during May 2012 to May 2017, with entries from 317,000 providers at 360 U.S. hospitals. The review identified 84,040 patients with a diagnosis of celiac disease, 15,360 with eosinophilic esophagitis, 1,440 with eosinophilic gastritis, and 800 with eosinophilic colitis. This worked out to a 5-year prevalence rate of 234.8 cases of celiac disease per 100,000 patients (0.235%), an eosinophilic esophagitis prevalence of 43.7 per 100,000, an eosinophilic gastroenteritis rate of 4.0 per 100,000, and an eosinophilic colitis rate of 2.2 per 100,000, said Dr. Mansoor, a gastroenterologist at University Hospitals Cleveland Medical Center.
The prevalence of celiac disease among patients with eosinophilic gastroenteritis or colitis was higher than in the eosinophilic esophagitis patients, with rates of 3.5% and 3.7%, respectively, that translated into odds ratios about 16-fold higher than the prevalence rates in the general population for both of these eosionophilic disorders.
The analyses reported by Dr. Mansoor also showed that the prevalence of celiac disease among patients with eosinophilic esophagitis was nearly twice as high in children (not more than 18 years old) as in adults and 50% higher in women than in men. These age and sex differences were both statistically significant.
Dr. Mansoor had no disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: Among patients with eosinophilic esophagitis, the celiac disease prevalence was ninefold higher than in the general population.
Data source: Review of more than 35 million U.S. patients during 2012-2017.
Disclosures: Dr. Mansoor had no disclosures.
Home-based cognitive-behavioral therapy aids IBS
ORLANDO – A 10-week program of home-based cognitive-behavioral therapy led to significantly better improvements in irritable bowel syndrome than did a control education program in a prospective, randomized, single-center trial with 436 patients.
Study data also showed that the improvements produced by the home-based cognitive-behavioral therapy (CBT) program were durable, persisting in 63% of high responders out to 6 months after treatment, Jeffrey M. Lackner, PsyD, said at the World Congress of Gastroenterology at ACG 2017.
He suggested that the minimal contact, home-based approach actually enhanced the efficacy of the CBT training that patients received.
“Patients are given tasks to carry out. Responsibility is placed on them. It changes the dynamic between the clinician and patient,” Dr. Lackner said. Skills patients learned during the minimal contact sessions included self-monitoring, muscle relaxation, worry control, problem solving, and modification of core beliefs.
The study enrolled adults up to 70 years old with at least moderately severe IBS symptoms at least twice weekly who met the Rome III diagnostic criteria. When patients performed a self-assessment 2 weeks after the end of the 10-week intervention, 61% of those in the home-based CBT program group rated themselves as much or very much improved, compared with 55% of patients who received standard CBT and 44% of patients in the control group, who attended generic education sessions. The differences between each of the two CBT groups and the controls were statistically significant. Patient assessments performed by blinded gastroenterologists rated 56% of the home-based CBT patients as much or very much improved, compared with 51% of those who received standard CBT and 40% of the controls.
When reassessed 3 and 6 months later, the edge that home-based CBT patients showed over the control patients persisted. After 6 months off treatment, 57% of those who received home-based CBT continued to say they were much or very much improved over their baseline status, compared with 47% of the controls.
Dr. Lackner’s analysis also examined whether patients treated with CBT, either standard or home based, went into remission. He defined remission as having no or only mild symptoms during an assessment 2 weeks after the end of the intervention and then maintaining this response out to 6 months. No or only mild symptoms were reported by 35% of all CBT patients soon after treatment, compared with 23% of the controls. Six months later, 63% of the high-responding patients on CBT and 52% of the high responders with education maintained their high response.
“CBT appears to have an enduring effect that protects against subsequent relapse and recurrence in a sizable subsample of patients,” he concluded. The findings “suggest possible disease modification by CBT.”
Dr. Lackner had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
ORLANDO – A 10-week program of home-based cognitive-behavioral therapy led to significantly better improvements in irritable bowel syndrome than did a control education program in a prospective, randomized, single-center trial with 436 patients.
Study data also showed that the improvements produced by the home-based cognitive-behavioral therapy (CBT) program were durable, persisting in 63% of high responders out to 6 months after treatment, Jeffrey M. Lackner, PsyD, said at the World Congress of Gastroenterology at ACG 2017.
He suggested that the minimal contact, home-based approach actually enhanced the efficacy of the CBT training that patients received.
“Patients are given tasks to carry out. Responsibility is placed on them. It changes the dynamic between the clinician and patient,” Dr. Lackner said. Skills patients learned during the minimal contact sessions included self-monitoring, muscle relaxation, worry control, problem solving, and modification of core beliefs.
The study enrolled adults up to 70 years old with at least moderately severe IBS symptoms at least twice weekly who met the Rome III diagnostic criteria. When patients performed a self-assessment 2 weeks after the end of the 10-week intervention, 61% of those in the home-based CBT program group rated themselves as much or very much improved, compared with 55% of patients who received standard CBT and 44% of patients in the control group, who attended generic education sessions. The differences between each of the two CBT groups and the controls were statistically significant. Patient assessments performed by blinded gastroenterologists rated 56% of the home-based CBT patients as much or very much improved, compared with 51% of those who received standard CBT and 40% of the controls.
When reassessed 3 and 6 months later, the edge that home-based CBT patients showed over the control patients persisted. After 6 months off treatment, 57% of those who received home-based CBT continued to say they were much or very much improved over their baseline status, compared with 47% of the controls.
Dr. Lackner’s analysis also examined whether patients treated with CBT, either standard or home based, went into remission. He defined remission as having no or only mild symptoms during an assessment 2 weeks after the end of the intervention and then maintaining this response out to 6 months. No or only mild symptoms were reported by 35% of all CBT patients soon after treatment, compared with 23% of the controls. Six months later, 63% of the high-responding patients on CBT and 52% of the high responders with education maintained their high response.
“CBT appears to have an enduring effect that protects against subsequent relapse and recurrence in a sizable subsample of patients,” he concluded. The findings “suggest possible disease modification by CBT.”
Dr. Lackner had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
ORLANDO – A 10-week program of home-based cognitive-behavioral therapy led to significantly better improvements in irritable bowel syndrome than did a control education program in a prospective, randomized, single-center trial with 436 patients.
Study data also showed that the improvements produced by the home-based cognitive-behavioral therapy (CBT) program were durable, persisting in 63% of high responders out to 6 months after treatment, Jeffrey M. Lackner, PsyD, said at the World Congress of Gastroenterology at ACG 2017.
He suggested that the minimal contact, home-based approach actually enhanced the efficacy of the CBT training that patients received.
“Patients are given tasks to carry out. Responsibility is placed on them. It changes the dynamic between the clinician and patient,” Dr. Lackner said. Skills patients learned during the minimal contact sessions included self-monitoring, muscle relaxation, worry control, problem solving, and modification of core beliefs.
The study enrolled adults up to 70 years old with at least moderately severe IBS symptoms at least twice weekly who met the Rome III diagnostic criteria. When patients performed a self-assessment 2 weeks after the end of the 10-week intervention, 61% of those in the home-based CBT program group rated themselves as much or very much improved, compared with 55% of patients who received standard CBT and 44% of patients in the control group, who attended generic education sessions. The differences between each of the two CBT groups and the controls were statistically significant. Patient assessments performed by blinded gastroenterologists rated 56% of the home-based CBT patients as much or very much improved, compared with 51% of those who received standard CBT and 40% of the controls.
When reassessed 3 and 6 months later, the edge that home-based CBT patients showed over the control patients persisted. After 6 months off treatment, 57% of those who received home-based CBT continued to say they were much or very much improved over their baseline status, compared with 47% of the controls.
Dr. Lackner’s analysis also examined whether patients treated with CBT, either standard or home based, went into remission. He defined remission as having no or only mild symptoms during an assessment 2 weeks after the end of the intervention and then maintaining this response out to 6 months. No or only mild symptoms were reported by 35% of all CBT patients soon after treatment, compared with 23% of the controls. Six months later, 63% of the high-responding patients on CBT and 52% of the high responders with education maintained their high response.
“CBT appears to have an enduring effect that protects against subsequent relapse and recurrence in a sizable subsample of patients,” he concluded. The findings “suggest possible disease modification by CBT.”
Dr. Lackner had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: After completion of a 10-week treatment, 61% of CBT patients and 44% of controls showed either much or very much improvement.
Data source: A prospective, randomized, single-center study with 436 patients.
Disclosures: Dr. Lackner had no relevant financial disclosures.
Role grows for heart failure patient-reported outcomes
DALLAS – The Food and Drug Administration is keenly seeking patient-reported outcomes as endpoints in cardiovascular drug or device trials, particularly for heart failure patients, but the bar remains high for getting such an outcome into labeling, said agency officials who regulate cardiovascular disease therapies.
The FDA issued guidance nearly 8 years ago on how to integrate patient-reported outcome (PRO) measures into medical product development, but so far no heart failure drug nor device has met the agency’s standards for documented success in improving a PRO, despite the clear need for these patients to receive patient-centered care, clinicians said.
“We don’t yet have a patient-reported outcome in a label for heart failure,” Paul A. Heidenreich, MD, said during a session on PROs at the annual scientific meeting of the Heart Failure Society of America. He voiced hope that a PRO might end up on the label of a heart failure drug or device sometime in 2018. “Almost half of FDA submissions now include a PRO” as part of the data package, added Dr. Heidenreich, a cardiologist and professor of medicine at Stanford (Calif.) University.
For years, PROs for heart failure weren’t often used in trials, and they remain largely absent from routine practice – an absence Dr. Heidenreich lamented. “Just focusing on mortality in heart failure is really not patient centered,” he said.
Heart failure physicians “are very good at disease-centered care” that focuses on survival and reducing hospitalizations, but “survival is often not as important to patients,” noted Mary Norine Walsh, MD, medical director of the heart failure and cardiac transplantation program at St. Vincent Medical Group in Indianapolis. She suggested “tailoring treatment to improve patient symptoms, physical function, and quality of life” without necessarily reducing hospital readmissions or increasing survival rates. “Self-reported measures have more meaning for patients,” she said, and called for using PROs to better target interventions to the patients who can most benefit from them.
Two FDA representatives who spoke during the session agreed on the importance of PROs and attested to the agency’s interest in greater reliance on them.
“PROs are a critical complement to the other measures made in device trials,” said Bram Zuckerman, MD, director of the FDA’s division of cardiovascular devices. “We need PRO information because it reflects important aspects of patients’ health-related quality of life.”
The most commonly used PRO measures in device trials today are the Kansas City Cardiomyopathy Questionnaire (J Am Coll Cardiol. 2000 Apr;35[5]:1245-55) and the Minnesota Living With Heart Failure questionnaire, he noted.
“Neither is perfect, but there is a track record in heart failure device development that these two PROs can be helpful.” The FDA’s cardiovascular device division “wants to use PRO information,” Dr. Zuckerman said.
“All-cause mortality is the most unbiased endpoint, but there is interest in PROs,” agreed Ebony Dashiell-Aje, PhD, from the FDA’s office of new drugs in the Center for Drug Evaluation and Research. She highlighted the encouragement that the FDA gave to drug and device developers to include PROs in trials, both in its 2009 guidance document as well as in a “roadmap” from the agency on how to measure PROs in clinical trials. “Unfortunately, in heart failure we struggle to find tools that can adequately measure the patient’s perspective and be sensitive enough to detect a treatment benefit,” she said.
Norman Stockbridge, MD, director of the division of cardiovascular and renal products in the agency’s Office of Drug Evaluation, cited even bigger barriers to FDA approval of PROs as labeled effects from drugs or devices.
Getting a PRO endpoint supported by clinical-trial results that qualify it for an FDA label faces two big challenges. One challenge, he said, is “how much of an effect we need to see in a complex scoring algorithm to know that patients actually received some benefit in a disease that often varies from day to day and from week to week.” The second challenge is that, “in a disease with a high background rate of bad outcomes, you need some evidence that the benefit [from the treatment] is worth any risk,” which is something that can be hard to prove in heart failure when many patients don’t live more than 2 years with the disease, Dr. Stockbridge said in an interview.
“You need to be able to make the argument that the [PRO] benefit is likely perceptible to patients, but that is only half the problem. The other half is whether the developer can rule out that survival is not less than it would have been with no treatment. If patients take this, will they feel better but have a greater risk of being hurt?”
So far, no drug or device developer has succeeded in proving this to the FDA, despite the agency’s 2009 guidance on how it could be done.
That guidance “is one of the two worst and most destructive guidance documents we ever published,” Dr. Stockbridge declared.
Dr. Walsh, Dr. Heidenreich, Dr. Zuckerman, Dr. Dashiell-Aje, and Dr. Stockbridge had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
DALLAS – The Food and Drug Administration is keenly seeking patient-reported outcomes as endpoints in cardiovascular drug or device trials, particularly for heart failure patients, but the bar remains high for getting such an outcome into labeling, said agency officials who regulate cardiovascular disease therapies.
The FDA issued guidance nearly 8 years ago on how to integrate patient-reported outcome (PRO) measures into medical product development, but so far no heart failure drug nor device has met the agency’s standards for documented success in improving a PRO, despite the clear need for these patients to receive patient-centered care, clinicians said.
“We don’t yet have a patient-reported outcome in a label for heart failure,” Paul A. Heidenreich, MD, said during a session on PROs at the annual scientific meeting of the Heart Failure Society of America. He voiced hope that a PRO might end up on the label of a heart failure drug or device sometime in 2018. “Almost half of FDA submissions now include a PRO” as part of the data package, added Dr. Heidenreich, a cardiologist and professor of medicine at Stanford (Calif.) University.
For years, PROs for heart failure weren’t often used in trials, and they remain largely absent from routine practice – an absence Dr. Heidenreich lamented. “Just focusing on mortality in heart failure is really not patient centered,” he said.
Heart failure physicians “are very good at disease-centered care” that focuses on survival and reducing hospitalizations, but “survival is often not as important to patients,” noted Mary Norine Walsh, MD, medical director of the heart failure and cardiac transplantation program at St. Vincent Medical Group in Indianapolis. She suggested “tailoring treatment to improve patient symptoms, physical function, and quality of life” without necessarily reducing hospital readmissions or increasing survival rates. “Self-reported measures have more meaning for patients,” she said, and called for using PROs to better target interventions to the patients who can most benefit from them.
Two FDA representatives who spoke during the session agreed on the importance of PROs and attested to the agency’s interest in greater reliance on them.
“PROs are a critical complement to the other measures made in device trials,” said Bram Zuckerman, MD, director of the FDA’s division of cardiovascular devices. “We need PRO information because it reflects important aspects of patients’ health-related quality of life.”
The most commonly used PRO measures in device trials today are the Kansas City Cardiomyopathy Questionnaire (J Am Coll Cardiol. 2000 Apr;35[5]:1245-55) and the Minnesota Living With Heart Failure questionnaire, he noted.
“Neither is perfect, but there is a track record in heart failure device development that these two PROs can be helpful.” The FDA’s cardiovascular device division “wants to use PRO information,” Dr. Zuckerman said.
“All-cause mortality is the most unbiased endpoint, but there is interest in PROs,” agreed Ebony Dashiell-Aje, PhD, from the FDA’s office of new drugs in the Center for Drug Evaluation and Research. She highlighted the encouragement that the FDA gave to drug and device developers to include PROs in trials, both in its 2009 guidance document as well as in a “roadmap” from the agency on how to measure PROs in clinical trials. “Unfortunately, in heart failure we struggle to find tools that can adequately measure the patient’s perspective and be sensitive enough to detect a treatment benefit,” she said.
Norman Stockbridge, MD, director of the division of cardiovascular and renal products in the agency’s Office of Drug Evaluation, cited even bigger barriers to FDA approval of PROs as labeled effects from drugs or devices.
Getting a PRO endpoint supported by clinical-trial results that qualify it for an FDA label faces two big challenges. One challenge, he said, is “how much of an effect we need to see in a complex scoring algorithm to know that patients actually received some benefit in a disease that often varies from day to day and from week to week.” The second challenge is that, “in a disease with a high background rate of bad outcomes, you need some evidence that the benefit [from the treatment] is worth any risk,” which is something that can be hard to prove in heart failure when many patients don’t live more than 2 years with the disease, Dr. Stockbridge said in an interview.
“You need to be able to make the argument that the [PRO] benefit is likely perceptible to patients, but that is only half the problem. The other half is whether the developer can rule out that survival is not less than it would have been with no treatment. If patients take this, will they feel better but have a greater risk of being hurt?”
So far, no drug or device developer has succeeded in proving this to the FDA, despite the agency’s 2009 guidance on how it could be done.
That guidance “is one of the two worst and most destructive guidance documents we ever published,” Dr. Stockbridge declared.
Dr. Walsh, Dr. Heidenreich, Dr. Zuckerman, Dr. Dashiell-Aje, and Dr. Stockbridge had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
DALLAS – The Food and Drug Administration is keenly seeking patient-reported outcomes as endpoints in cardiovascular drug or device trials, particularly for heart failure patients, but the bar remains high for getting such an outcome into labeling, said agency officials who regulate cardiovascular disease therapies.
The FDA issued guidance nearly 8 years ago on how to integrate patient-reported outcome (PRO) measures into medical product development, but so far no heart failure drug nor device has met the agency’s standards for documented success in improving a PRO, despite the clear need for these patients to receive patient-centered care, clinicians said.
“We don’t yet have a patient-reported outcome in a label for heart failure,” Paul A. Heidenreich, MD, said during a session on PROs at the annual scientific meeting of the Heart Failure Society of America. He voiced hope that a PRO might end up on the label of a heart failure drug or device sometime in 2018. “Almost half of FDA submissions now include a PRO” as part of the data package, added Dr. Heidenreich, a cardiologist and professor of medicine at Stanford (Calif.) University.
For years, PROs for heart failure weren’t often used in trials, and they remain largely absent from routine practice – an absence Dr. Heidenreich lamented. “Just focusing on mortality in heart failure is really not patient centered,” he said.
Heart failure physicians “are very good at disease-centered care” that focuses on survival and reducing hospitalizations, but “survival is often not as important to patients,” noted Mary Norine Walsh, MD, medical director of the heart failure and cardiac transplantation program at St. Vincent Medical Group in Indianapolis. She suggested “tailoring treatment to improve patient symptoms, physical function, and quality of life” without necessarily reducing hospital readmissions or increasing survival rates. “Self-reported measures have more meaning for patients,” she said, and called for using PROs to better target interventions to the patients who can most benefit from them.
Two FDA representatives who spoke during the session agreed on the importance of PROs and attested to the agency’s interest in greater reliance on them.
“PROs are a critical complement to the other measures made in device trials,” said Bram Zuckerman, MD, director of the FDA’s division of cardiovascular devices. “We need PRO information because it reflects important aspects of patients’ health-related quality of life.”
The most commonly used PRO measures in device trials today are the Kansas City Cardiomyopathy Questionnaire (J Am Coll Cardiol. 2000 Apr;35[5]:1245-55) and the Minnesota Living With Heart Failure questionnaire, he noted.
“Neither is perfect, but there is a track record in heart failure device development that these two PROs can be helpful.” The FDA’s cardiovascular device division “wants to use PRO information,” Dr. Zuckerman said.
“All-cause mortality is the most unbiased endpoint, but there is interest in PROs,” agreed Ebony Dashiell-Aje, PhD, from the FDA’s office of new drugs in the Center for Drug Evaluation and Research. She highlighted the encouragement that the FDA gave to drug and device developers to include PROs in trials, both in its 2009 guidance document as well as in a “roadmap” from the agency on how to measure PROs in clinical trials. “Unfortunately, in heart failure we struggle to find tools that can adequately measure the patient’s perspective and be sensitive enough to detect a treatment benefit,” she said.
Norman Stockbridge, MD, director of the division of cardiovascular and renal products in the agency’s Office of Drug Evaluation, cited even bigger barriers to FDA approval of PROs as labeled effects from drugs or devices.
Getting a PRO endpoint supported by clinical-trial results that qualify it for an FDA label faces two big challenges. One challenge, he said, is “how much of an effect we need to see in a complex scoring algorithm to know that patients actually received some benefit in a disease that often varies from day to day and from week to week.” The second challenge is that, “in a disease with a high background rate of bad outcomes, you need some evidence that the benefit [from the treatment] is worth any risk,” which is something that can be hard to prove in heart failure when many patients don’t live more than 2 years with the disease, Dr. Stockbridge said in an interview.
“You need to be able to make the argument that the [PRO] benefit is likely perceptible to patients, but that is only half the problem. The other half is whether the developer can rule out that survival is not less than it would have been with no treatment. If patients take this, will they feel better but have a greater risk of being hurt?”
So far, no drug or device developer has succeeded in proving this to the FDA, despite the agency’s 2009 guidance on how it could be done.
That guidance “is one of the two worst and most destructive guidance documents we ever published,” Dr. Stockbridge declared.
Dr. Walsh, Dr. Heidenreich, Dr. Zuckerman, Dr. Dashiell-Aje, and Dr. Stockbridge had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM THE HFSA ANNUAL SCIENTIFIC MEETING
VIDEO: Gastroenterologist survey shows opportunity to expand Lynch syndrome testing
ORLANDO – A large percentage of U.S. gastroenterologists said that they don’t routinely order genetic testing for Lynch syndrome for patients with early-onset colorectal cancer, often because the physicians believe that the test is too expensive, or because they are unfamiliar with interpreting or applying the results, according to survey replies from 442 gastroenterologists.
Another factor hindering broader screening for Lynch syndrome (also known as hereditary nonpolyposis colorectal cancer) is that many of the surveyed gastroenterologists did not see themselves as having primary responsibility for ordering Lynch syndrome testing in patients who develop colorectal cancer before reaching age 50 years, Jordan J. Karlitz, MD, and his associates reported in a poster at the World Congress of Gastroenterology at ACG 2017.
The survey results showed that only a third of the survey respondents believed it primarily was the attending gastroenterologist’s responsibility to order testing for Lynch syndrome using either a microsatellite DNA instability test or by immunohistochemistry. A larger percentage, 38%, said that ordering one of these tests was something that a pathologist should arrange, 15% said it was primarily the responsibility of the attending medical oncologist, and the remaining respondents cited a surgeon or genetic counselor as having primary responsibility for ordering the test.
This absence of a clear consensus on who orders the test shows a “diffusion of responsibility” that often means testing is never ordered, Dr. Karlitz said in a video interview. What’s needed instead is “reflex testing” that’s done automatically for appropriate patients, an approach that has become standard at several U.S. medical centers, he noted.
The survey Dr. Karlitz and his associates ran stemmed from a report they published in 2015 that focused on management of the 274 patients diagnosed with early-onset colorectal cancer in Louisiana during 2011, defined as cancers diagnosed in patients aged 50 years or younger. Data collected in the Louisiana Tumor Registry showed that Lynch syndrome testing occurred for only 23% of these patients, the researchers reported (Am J Gastroenterol. 2015 Jul;110[7]:948-55).
To better understand the underpinnings of this low testing rate they sent a survey about Lynch syndrome testing by email in March 2017 to nearly 12,000 physicians on the membership roster of the American College of Gastroenterology. They received 455 replies, with 442 (97%) of the responses from gastroenterologists. When asked why they might not order Lynch syndrome testing for patients with early-onset colorectal cancer, 22% said the cost of testing was prohibitive, 18% blamed their lack of familiarity with the Lynch syndrome tests and how to properly interpret their results, and 15% attributed their decision to a lack of easy access to genetic counseling for their patients, with additional reasons cited by fewer respondents.
Dr. Karlitz noted that current recommendations from the National Comprehensive Cancer Network call for Lynch syndrome testing for all patients who develop colorectal cancer regardless of their age at diagnosis.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
ORLANDO – A large percentage of U.S. gastroenterologists said that they don’t routinely order genetic testing for Lynch syndrome for patients with early-onset colorectal cancer, often because the physicians believe that the test is too expensive, or because they are unfamiliar with interpreting or applying the results, according to survey replies from 442 gastroenterologists.
Another factor hindering broader screening for Lynch syndrome (also known as hereditary nonpolyposis colorectal cancer) is that many of the surveyed gastroenterologists did not see themselves as having primary responsibility for ordering Lynch syndrome testing in patients who develop colorectal cancer before reaching age 50 years, Jordan J. Karlitz, MD, and his associates reported in a poster at the World Congress of Gastroenterology at ACG 2017.
The survey results showed that only a third of the survey respondents believed it primarily was the attending gastroenterologist’s responsibility to order testing for Lynch syndrome using either a microsatellite DNA instability test or by immunohistochemistry. A larger percentage, 38%, said that ordering one of these tests was something that a pathologist should arrange, 15% said it was primarily the responsibility of the attending medical oncologist, and the remaining respondents cited a surgeon or genetic counselor as having primary responsibility for ordering the test.
This absence of a clear consensus on who orders the test shows a “diffusion of responsibility” that often means testing is never ordered, Dr. Karlitz said in a video interview. What’s needed instead is “reflex testing” that’s done automatically for appropriate patients, an approach that has become standard at several U.S. medical centers, he noted.
The survey Dr. Karlitz and his associates ran stemmed from a report they published in 2015 that focused on management of the 274 patients diagnosed with early-onset colorectal cancer in Louisiana during 2011, defined as cancers diagnosed in patients aged 50 years or younger. Data collected in the Louisiana Tumor Registry showed that Lynch syndrome testing occurred for only 23% of these patients, the researchers reported (Am J Gastroenterol. 2015 Jul;110[7]:948-55).
To better understand the underpinnings of this low testing rate they sent a survey about Lynch syndrome testing by email in March 2017 to nearly 12,000 physicians on the membership roster of the American College of Gastroenterology. They received 455 replies, with 442 (97%) of the responses from gastroenterologists. When asked why they might not order Lynch syndrome testing for patients with early-onset colorectal cancer, 22% said the cost of testing was prohibitive, 18% blamed their lack of familiarity with the Lynch syndrome tests and how to properly interpret their results, and 15% attributed their decision to a lack of easy access to genetic counseling for their patients, with additional reasons cited by fewer respondents.
Dr. Karlitz noted that current recommendations from the National Comprehensive Cancer Network call for Lynch syndrome testing for all patients who develop colorectal cancer regardless of their age at diagnosis.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
ORLANDO – A large percentage of U.S. gastroenterologists said that they don’t routinely order genetic testing for Lynch syndrome for patients with early-onset colorectal cancer, often because the physicians believe that the test is too expensive, or because they are unfamiliar with interpreting or applying the results, according to survey replies from 442 gastroenterologists.
Another factor hindering broader screening for Lynch syndrome (also known as hereditary nonpolyposis colorectal cancer) is that many of the surveyed gastroenterologists did not see themselves as having primary responsibility for ordering Lynch syndrome testing in patients who develop colorectal cancer before reaching age 50 years, Jordan J. Karlitz, MD, and his associates reported in a poster at the World Congress of Gastroenterology at ACG 2017.
The survey results showed that only a third of the survey respondents believed it primarily was the attending gastroenterologist’s responsibility to order testing for Lynch syndrome using either a microsatellite DNA instability test or by immunohistochemistry. A larger percentage, 38%, said that ordering one of these tests was something that a pathologist should arrange, 15% said it was primarily the responsibility of the attending medical oncologist, and the remaining respondents cited a surgeon or genetic counselor as having primary responsibility for ordering the test.
This absence of a clear consensus on who orders the test shows a “diffusion of responsibility” that often means testing is never ordered, Dr. Karlitz said in a video interview. What’s needed instead is “reflex testing” that’s done automatically for appropriate patients, an approach that has become standard at several U.S. medical centers, he noted.
The survey Dr. Karlitz and his associates ran stemmed from a report they published in 2015 that focused on management of the 274 patients diagnosed with early-onset colorectal cancer in Louisiana during 2011, defined as cancers diagnosed in patients aged 50 years or younger. Data collected in the Louisiana Tumor Registry showed that Lynch syndrome testing occurred for only 23% of these patients, the researchers reported (Am J Gastroenterol. 2015 Jul;110[7]:948-55).
To better understand the underpinnings of this low testing rate they sent a survey about Lynch syndrome testing by email in March 2017 to nearly 12,000 physicians on the membership roster of the American College of Gastroenterology. They received 455 replies, with 442 (97%) of the responses from gastroenterologists. When asked why they might not order Lynch syndrome testing for patients with early-onset colorectal cancer, 22% said the cost of testing was prohibitive, 18% blamed their lack of familiarity with the Lynch syndrome tests and how to properly interpret their results, and 15% attributed their decision to a lack of easy access to genetic counseling for their patients, with additional reasons cited by fewer respondents.
Dr. Karlitz noted that current recommendations from the National Comprehensive Cancer Network call for Lynch syndrome testing for all patients who develop colorectal cancer regardless of their age at diagnosis.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
AT THE WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: Among gastroenterologist survey respondents, one-third said they had primary responsibility for ordering Lynch syndrome testing.
Data source: Survey emailed to members of the American College of Gastroenterology and completed by 455 physicians and surgeons.
Disclosures: Dr. Karlitz has been a speaker on behalf of Myriad Genetics, a company that markets genetic tests for Lynch syndrome.
CardioMEMS shows real-world success as use expands
DALLAS – Management of outpatients with advanced heart failure using an implanted pulmonary artery pressure monitor continues to show real-world efficacy and safety at least as impressive as in the pivotal trial for the device.
Data from the first waves of patients to receive the CardioMEMS implanted pulmonary artery pressure (PAP) monitor since it got Food and Drug Administration marketing approval in May 2014 also showed steady uptake of this fluid volume management strategy for patients with advanced heart failure, despite Medicare reimbursement issues in some U.S. regions, J. Thomas Heywood, MD, said at the at the annual scientific meeting of the Heart Failure Society of America. He estimated that more than 6,000 U.S. heart failure patients have now had a CardioMEMS PAP monitor implanted.
“The clinicians using CardioMEMS now have a lot more experience” than they had during the trial, he said in an interview. “They have more experience using the device, they know what treatments to use to lower PAP more effectively, and they are now convinced that patients will benefit from reducing diastolic PAP.”
Dr. Heywood estimated that tens of thousands more U.S. heart failure patients with New York Heart Association class III disease and a recent history of at least one heart failure hospitalization are eligible to receive an implanted PAP monitor, dwarfing the more than 6,000 patients who received a device so far.
The postapproval study
The newest efficacy data come from the first 300 patients enrolled in the CardioMEMS HF System Post Approval Study, a registry of patients receiving an implanted PAP monitor funded by the device’s manufacturer and scheduled to include a total of 1,200 patients. Dr. Heywood said full enrollment was on track for completion by the end of October 2017.
The first 300 patients enrolled in the postapproval study were older than the CHAMPION cohort; they averaged about 69 years of age, compared with about 62 years in CHAMPION, were more often women (38% vs. 28% in CHAMPION), and were more likely to have heart failure with preserved ejection fraction (41% vs. about 22%).
A similar pattern existed for the 6-month cumulative tally of PAP area under the curve, which showed an average rise of 42 mm Hg/day in the CHAMPION control patients, an average drop of 160 mm Hg/day in the CHAMPION patients managed using their CardioMEMS data, and a drop of 281 mm Hg/day in the 300 postapproval study patients.
“We’re now using the implanted sensor in a broader population of patients, and one wonders whether the effect will be diluted. What we see is at least as good as in the CHAMPION trial. This is just an early snapshot, but it is exciting that we see no erosion of the benefit. It’s a great indication that the correct patients are receiving it,” Dr. Raval said while presenting a poster at the meeting.
Further scrutiny of the same 300 patients showed another feature of the impact of PAP monitoring on patient outcomes: The first 90 days with the PAP monitor in place led to a greater number of tweaks in patient treatment and a steady fall in PAP. During days 91-180, PAP tended to level off, the number of medication adjustments dropped, and heart failure hospitalizations fell even more than in the first 90 days, Joanna M. Joly, MD, reported in a separate poster at the meeting.
The data showed “effective reduction” of PAP during the second half of the study despite fewer medication adjustments. How was that possible? Patients who transmit data on their PAPs undergo “modeling of their behavior” based on the feedback they receive from the device, Dr. Joly suggested. Regular measurement of their PAP and seeing how the number relates to their clinical status helps patients “understand the impact of their nonadherence to diet and their medications.” Another factor could be the growing familiarity clinicians develop over time with PAP fluctuations that individual patients display repeatedly that are usually self-correcting. Also, patients may undergo “hemodynamic remodeling” that results in improved self-correction of minor shifts in fluid volume and vascular tone, she said.
This pattern of a reduced need for interventions after the first 90 days with a PAP implant suggests that many patients managed this way may be able to transition to care largely delivered by local providers, or even play a greater role in their own self-care once their PAP and clinical state stabilizes, Dr. Joly said.
The findings imply that by the end of the first 90 days, “patients accept the device and manage themselves better. It becomes basically a behavioral device” that helps patients better optimize their diet and behavior, Dr. Raval observed.
Safety holds steady
Continued real-world use of PAP monitoring has also resulted in new safety insights. During the first 3 years when the CardioMEMS device was on the U.S. market, May 2014–May 2017, the FDA’s adverse event reporting system for devices, the Manufacturer and User Facility Device Experience (MAUDE) received reports on 177 unique adverse events in 155 patients implanted with a PAP monitor, Muthiah Vaduganathan, MD, reported at the meeting. During the same 3-year period, he estimated that at least 5,500 U.S. patients had received a CardioMEMS device, based on data Dr. Vaduganathan obtained from the manufacturer, Abbott. This works out to an adverse event rate of about 2.8%, virtually identical to the rate reported from CHAMPION, noted Dr. Vaduganathan, a cardiologist also at Brigham and Women’s.
Analysis of both the 22 deaths as well as the episodes of pulmonary artery injury or hemoptysis showed that the preponderance occurred relatively early after introduction for U.S. use, suggesting that “a learning curve may exist for the most serious complications,” he said. “Improved safety and device durability may result from careful patient selection, increased operator training, and refined technologies.”
Dr. Vaduganathan cautioned that the MAUDE database is limited by its bias toward serious adverse events, selective reporting, and lack of adjudication for the reported events. Concurrently with his report at the meeting, a written version appeared online (JAMA Cardiol. 2017 Sep 18. doi:10.1001/jamacardio.2017.3791).
“The adverse event rate was reassuringly low, well below the accepted threshold for device safety. It bodes favorably for the device,” he said in an interview.
“But with a passive surveillance system like MAUDE, adverse events are likely underreported; we see in MAUDE the most severe adverse events. There is certainly a larger spectrum of more minor events that we are not seeing, but I think these numbers accurately reflect serious events.” A full registry of every U.S. patient who receives the device, similar to what’s in place for U.S. patients who undergo transcatheter aortic valve replacement, would provide a more complete picture of the risks, Dr. Vaduganathan suggested.
He also voiced some surprise about the frequency of pulmonary artery injury, which was not as apparent in the 550 total patients enrolled in CHAMPION. Clinicians who place the PAP monitor are required to first take a training program, but the manufacturer has no mandated minimum number of placements an operator must assist on before launching a new CardioMEMS practice, Dr. Vaduganathan said. Many of the pulmonary artery injuries reported to MAUDE resulted from wire perforations that resulted from loss of wire control, he noted.
Clarifying the optimal CardioMEMS recipients
PAP monitoring for patients with advanced heart failure “is a major advance for certain patients who have historically been very challenging to manage,” especially patients with heart failure with preserved ejection fraction, which has few other treatment options. But “it’s often difficult to know when to pull the trigger” and proceed with placing a PAP monitor in an eligible patient, he said. “Greater experience will help us better understand that,” Dr. Vaduganathan predicted.
Dr. Heywood said that, in addition to the standard criteria of NYHA class III symptoms and a recent history of a heart failure hospitalization, the other clinical feature he looks for in a patient who is a possible CardioMEMS recipient is a persistently elevated systolic PAP as measured using echocardiography.
“These are patients with evidence of an ongoing hemodynamic problem despite treatment, and I need more data to do a better job of getting their PAP down.” Although the PAP that patients self-measure once they have the device in place is their diastolic PAP, measuring systolic PAP by echo is usually a good surrogate for finding patients who also have a persistently elevated diastolic PAP, he explained.
Another important selection criterion is to look for the patients who are dying from heart failure rather than with heart failure, Dr. Heywood added.
“If heart failure is the major thing wrong, then we can improve their quality of life” by guiding fluid management with regular PAP measurement, especially patients with preserved left ventricular ejection fraction who have few other treatment options right now, he said.
The CardioMEMS HF System Post Approval Study is sponsored by Abbott, which markets CardioMEMS. Dr Heywood has been a consultant to and/or has received research funding from Abbott as well as Impedimed, Medtronic, Novartis, and Otsuka. Dr. Raval has been a consultant to Abbott. Dr. Joly and Dr. Vaduganathan had no disclosures.
[email protected]
On Twitter @mitchelzoler
DALLAS – Management of outpatients with advanced heart failure using an implanted pulmonary artery pressure monitor continues to show real-world efficacy and safety at least as impressive as in the pivotal trial for the device.
Data from the first waves of patients to receive the CardioMEMS implanted pulmonary artery pressure (PAP) monitor since it got Food and Drug Administration marketing approval in May 2014 also showed steady uptake of this fluid volume management strategy for patients with advanced heart failure, despite Medicare reimbursement issues in some U.S. regions, J. Thomas Heywood, MD, said at the at the annual scientific meeting of the Heart Failure Society of America. He estimated that more than 6,000 U.S. heart failure patients have now had a CardioMEMS PAP monitor implanted.
“The clinicians using CardioMEMS now have a lot more experience” than they had during the trial, he said in an interview. “They have more experience using the device, they know what treatments to use to lower PAP more effectively, and they are now convinced that patients will benefit from reducing diastolic PAP.”
Dr. Heywood estimated that tens of thousands more U.S. heart failure patients with New York Heart Association class III disease and a recent history of at least one heart failure hospitalization are eligible to receive an implanted PAP monitor, dwarfing the more than 6,000 patients who received a device so far.
The postapproval study
The newest efficacy data come from the first 300 patients enrolled in the CardioMEMS HF System Post Approval Study, a registry of patients receiving an implanted PAP monitor funded by the device’s manufacturer and scheduled to include a total of 1,200 patients. Dr. Heywood said full enrollment was on track for completion by the end of October 2017.
The first 300 patients enrolled in the postapproval study were older than the CHAMPION cohort; they averaged about 69 years of age, compared with about 62 years in CHAMPION, were more often women (38% vs. 28% in CHAMPION), and were more likely to have heart failure with preserved ejection fraction (41% vs. about 22%).
A similar pattern existed for the 6-month cumulative tally of PAP area under the curve, which showed an average rise of 42 mm Hg/day in the CHAMPION control patients, an average drop of 160 mm Hg/day in the CHAMPION patients managed using their CardioMEMS data, and a drop of 281 mm Hg/day in the 300 postapproval study patients.
“We’re now using the implanted sensor in a broader population of patients, and one wonders whether the effect will be diluted. What we see is at least as good as in the CHAMPION trial. This is just an early snapshot, but it is exciting that we see no erosion of the benefit. It’s a great indication that the correct patients are receiving it,” Dr. Raval said while presenting a poster at the meeting.
Further scrutiny of the same 300 patients showed another feature of the impact of PAP monitoring on patient outcomes: The first 90 days with the PAP monitor in place led to a greater number of tweaks in patient treatment and a steady fall in PAP. During days 91-180, PAP tended to level off, the number of medication adjustments dropped, and heart failure hospitalizations fell even more than in the first 90 days, Joanna M. Joly, MD, reported in a separate poster at the meeting.
The data showed “effective reduction” of PAP during the second half of the study despite fewer medication adjustments. How was that possible? Patients who transmit data on their PAPs undergo “modeling of their behavior” based on the feedback they receive from the device, Dr. Joly suggested. Regular measurement of their PAP and seeing how the number relates to their clinical status helps patients “understand the impact of their nonadherence to diet and their medications.” Another factor could be the growing familiarity clinicians develop over time with PAP fluctuations that individual patients display repeatedly that are usually self-correcting. Also, patients may undergo “hemodynamic remodeling” that results in improved self-correction of minor shifts in fluid volume and vascular tone, she said.
This pattern of a reduced need for interventions after the first 90 days with a PAP implant suggests that many patients managed this way may be able to transition to care largely delivered by local providers, or even play a greater role in their own self-care once their PAP and clinical state stabilizes, Dr. Joly said.
The findings imply that by the end of the first 90 days, “patients accept the device and manage themselves better. It becomes basically a behavioral device” that helps patients better optimize their diet and behavior, Dr. Raval observed.
Safety holds steady
Continued real-world use of PAP monitoring has also resulted in new safety insights. During the first 3 years when the CardioMEMS device was on the U.S. market, May 2014–May 2017, the FDA’s adverse event reporting system for devices, the Manufacturer and User Facility Device Experience (MAUDE) received reports on 177 unique adverse events in 155 patients implanted with a PAP monitor, Muthiah Vaduganathan, MD, reported at the meeting. During the same 3-year period, he estimated that at least 5,500 U.S. patients had received a CardioMEMS device, based on data Dr. Vaduganathan obtained from the manufacturer, Abbott. This works out to an adverse event rate of about 2.8%, virtually identical to the rate reported from CHAMPION, noted Dr. Vaduganathan, a cardiologist also at Brigham and Women’s.
Analysis of both the 22 deaths as well as the episodes of pulmonary artery injury or hemoptysis showed that the preponderance occurred relatively early after introduction for U.S. use, suggesting that “a learning curve may exist for the most serious complications,” he said. “Improved safety and device durability may result from careful patient selection, increased operator training, and refined technologies.”
Dr. Vaduganathan cautioned that the MAUDE database is limited by its bias toward serious adverse events, selective reporting, and lack of adjudication for the reported events. Concurrently with his report at the meeting, a written version appeared online (JAMA Cardiol. 2017 Sep 18. doi:10.1001/jamacardio.2017.3791).
“The adverse event rate was reassuringly low, well below the accepted threshold for device safety. It bodes favorably for the device,” he said in an interview.
“But with a passive surveillance system like MAUDE, adverse events are likely underreported; we see in MAUDE the most severe adverse events. There is certainly a larger spectrum of more minor events that we are not seeing, but I think these numbers accurately reflect serious events.” A full registry of every U.S. patient who receives the device, similar to what’s in place for U.S. patients who undergo transcatheter aortic valve replacement, would provide a more complete picture of the risks, Dr. Vaduganathan suggested.
He also voiced some surprise about the frequency of pulmonary artery injury, which was not as apparent in the 550 total patients enrolled in CHAMPION. Clinicians who place the PAP monitor are required to first take a training program, but the manufacturer has no mandated minimum number of placements an operator must assist on before launching a new CardioMEMS practice, Dr. Vaduganathan said. Many of the pulmonary artery injuries reported to MAUDE resulted from wire perforations that resulted from loss of wire control, he noted.
Clarifying the optimal CardioMEMS recipients
PAP monitoring for patients with advanced heart failure “is a major advance for certain patients who have historically been very challenging to manage,” especially patients with heart failure with preserved ejection fraction, which has few other treatment options. But “it’s often difficult to know when to pull the trigger” and proceed with placing a PAP monitor in an eligible patient, he said. “Greater experience will help us better understand that,” Dr. Vaduganathan predicted.
Dr. Heywood said that, in addition to the standard criteria of NYHA class III symptoms and a recent history of a heart failure hospitalization, the other clinical feature he looks for in a patient who is a possible CardioMEMS recipient is a persistently elevated systolic PAP as measured using echocardiography.
“These are patients with evidence of an ongoing hemodynamic problem despite treatment, and I need more data to do a better job of getting their PAP down.” Although the PAP that patients self-measure once they have the device in place is their diastolic PAP, measuring systolic PAP by echo is usually a good surrogate for finding patients who also have a persistently elevated diastolic PAP, he explained.
Another important selection criterion is to look for the patients who are dying from heart failure rather than with heart failure, Dr. Heywood added.
“If heart failure is the major thing wrong, then we can improve their quality of life” by guiding fluid management with regular PAP measurement, especially patients with preserved left ventricular ejection fraction who have few other treatment options right now, he said.
The CardioMEMS HF System Post Approval Study is sponsored by Abbott, which markets CardioMEMS. Dr Heywood has been a consultant to and/or has received research funding from Abbott as well as Impedimed, Medtronic, Novartis, and Otsuka. Dr. Raval has been a consultant to Abbott. Dr. Joly and Dr. Vaduganathan had no disclosures.
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On Twitter @mitchelzoler
DALLAS – Management of outpatients with advanced heart failure using an implanted pulmonary artery pressure monitor continues to show real-world efficacy and safety at least as impressive as in the pivotal trial for the device.
Data from the first waves of patients to receive the CardioMEMS implanted pulmonary artery pressure (PAP) monitor since it got Food and Drug Administration marketing approval in May 2014 also showed steady uptake of this fluid volume management strategy for patients with advanced heart failure, despite Medicare reimbursement issues in some U.S. regions, J. Thomas Heywood, MD, said at the at the annual scientific meeting of the Heart Failure Society of America. He estimated that more than 6,000 U.S. heart failure patients have now had a CardioMEMS PAP monitor implanted.
“The clinicians using CardioMEMS now have a lot more experience” than they had during the trial, he said in an interview. “They have more experience using the device, they know what treatments to use to lower PAP more effectively, and they are now convinced that patients will benefit from reducing diastolic PAP.”
Dr. Heywood estimated that tens of thousands more U.S. heart failure patients with New York Heart Association class III disease and a recent history of at least one heart failure hospitalization are eligible to receive an implanted PAP monitor, dwarfing the more than 6,000 patients who received a device so far.
The postapproval study
The newest efficacy data come from the first 300 patients enrolled in the CardioMEMS HF System Post Approval Study, a registry of patients receiving an implanted PAP monitor funded by the device’s manufacturer and scheduled to include a total of 1,200 patients. Dr. Heywood said full enrollment was on track for completion by the end of October 2017.
The first 300 patients enrolled in the postapproval study were older than the CHAMPION cohort; they averaged about 69 years of age, compared with about 62 years in CHAMPION, were more often women (38% vs. 28% in CHAMPION), and were more likely to have heart failure with preserved ejection fraction (41% vs. about 22%).
A similar pattern existed for the 6-month cumulative tally of PAP area under the curve, which showed an average rise of 42 mm Hg/day in the CHAMPION control patients, an average drop of 160 mm Hg/day in the CHAMPION patients managed using their CardioMEMS data, and a drop of 281 mm Hg/day in the 300 postapproval study patients.
“We’re now using the implanted sensor in a broader population of patients, and one wonders whether the effect will be diluted. What we see is at least as good as in the CHAMPION trial. This is just an early snapshot, but it is exciting that we see no erosion of the benefit. It’s a great indication that the correct patients are receiving it,” Dr. Raval said while presenting a poster at the meeting.
Further scrutiny of the same 300 patients showed another feature of the impact of PAP monitoring on patient outcomes: The first 90 days with the PAP monitor in place led to a greater number of tweaks in patient treatment and a steady fall in PAP. During days 91-180, PAP tended to level off, the number of medication adjustments dropped, and heart failure hospitalizations fell even more than in the first 90 days, Joanna M. Joly, MD, reported in a separate poster at the meeting.
The data showed “effective reduction” of PAP during the second half of the study despite fewer medication adjustments. How was that possible? Patients who transmit data on their PAPs undergo “modeling of their behavior” based on the feedback they receive from the device, Dr. Joly suggested. Regular measurement of their PAP and seeing how the number relates to their clinical status helps patients “understand the impact of their nonadherence to diet and their medications.” Another factor could be the growing familiarity clinicians develop over time with PAP fluctuations that individual patients display repeatedly that are usually self-correcting. Also, patients may undergo “hemodynamic remodeling” that results in improved self-correction of minor shifts in fluid volume and vascular tone, she said.
This pattern of a reduced need for interventions after the first 90 days with a PAP implant suggests that many patients managed this way may be able to transition to care largely delivered by local providers, or even play a greater role in their own self-care once their PAP and clinical state stabilizes, Dr. Joly said.
The findings imply that by the end of the first 90 days, “patients accept the device and manage themselves better. It becomes basically a behavioral device” that helps patients better optimize their diet and behavior, Dr. Raval observed.
Safety holds steady
Continued real-world use of PAP monitoring has also resulted in new safety insights. During the first 3 years when the CardioMEMS device was on the U.S. market, May 2014–May 2017, the FDA’s adverse event reporting system for devices, the Manufacturer and User Facility Device Experience (MAUDE) received reports on 177 unique adverse events in 155 patients implanted with a PAP monitor, Muthiah Vaduganathan, MD, reported at the meeting. During the same 3-year period, he estimated that at least 5,500 U.S. patients had received a CardioMEMS device, based on data Dr. Vaduganathan obtained from the manufacturer, Abbott. This works out to an adverse event rate of about 2.8%, virtually identical to the rate reported from CHAMPION, noted Dr. Vaduganathan, a cardiologist also at Brigham and Women’s.
Analysis of both the 22 deaths as well as the episodes of pulmonary artery injury or hemoptysis showed that the preponderance occurred relatively early after introduction for U.S. use, suggesting that “a learning curve may exist for the most serious complications,” he said. “Improved safety and device durability may result from careful patient selection, increased operator training, and refined technologies.”
Dr. Vaduganathan cautioned that the MAUDE database is limited by its bias toward serious adverse events, selective reporting, and lack of adjudication for the reported events. Concurrently with his report at the meeting, a written version appeared online (JAMA Cardiol. 2017 Sep 18. doi:10.1001/jamacardio.2017.3791).
“The adverse event rate was reassuringly low, well below the accepted threshold for device safety. It bodes favorably for the device,” he said in an interview.
“But with a passive surveillance system like MAUDE, adverse events are likely underreported; we see in MAUDE the most severe adverse events. There is certainly a larger spectrum of more minor events that we are not seeing, but I think these numbers accurately reflect serious events.” A full registry of every U.S. patient who receives the device, similar to what’s in place for U.S. patients who undergo transcatheter aortic valve replacement, would provide a more complete picture of the risks, Dr. Vaduganathan suggested.
He also voiced some surprise about the frequency of pulmonary artery injury, which was not as apparent in the 550 total patients enrolled in CHAMPION. Clinicians who place the PAP monitor are required to first take a training program, but the manufacturer has no mandated minimum number of placements an operator must assist on before launching a new CardioMEMS practice, Dr. Vaduganathan said. Many of the pulmonary artery injuries reported to MAUDE resulted from wire perforations that resulted from loss of wire control, he noted.
Clarifying the optimal CardioMEMS recipients
PAP monitoring for patients with advanced heart failure “is a major advance for certain patients who have historically been very challenging to manage,” especially patients with heart failure with preserved ejection fraction, which has few other treatment options. But “it’s often difficult to know when to pull the trigger” and proceed with placing a PAP monitor in an eligible patient, he said. “Greater experience will help us better understand that,” Dr. Vaduganathan predicted.
Dr. Heywood said that, in addition to the standard criteria of NYHA class III symptoms and a recent history of a heart failure hospitalization, the other clinical feature he looks for in a patient who is a possible CardioMEMS recipient is a persistently elevated systolic PAP as measured using echocardiography.
“These are patients with evidence of an ongoing hemodynamic problem despite treatment, and I need more data to do a better job of getting their PAP down.” Although the PAP that patients self-measure once they have the device in place is their diastolic PAP, measuring systolic PAP by echo is usually a good surrogate for finding patients who also have a persistently elevated diastolic PAP, he explained.
Another important selection criterion is to look for the patients who are dying from heart failure rather than with heart failure, Dr. Heywood added.
“If heart failure is the major thing wrong, then we can improve their quality of life” by guiding fluid management with regular PAP measurement, especially patients with preserved left ventricular ejection fraction who have few other treatment options right now, he said.
The CardioMEMS HF System Post Approval Study is sponsored by Abbott, which markets CardioMEMS. Dr Heywood has been a consultant to and/or has received research funding from Abbott as well as Impedimed, Medtronic, Novartis, and Otsuka. Dr. Raval has been a consultant to Abbott. Dr. Joly and Dr. Vaduganathan had no disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE HFSA ANNUAL SCIENTIFIC MEETING
VIDEO: Endoscopy surpasses surgery for acute necrotizing pancreatitis
ORLANDO – An endoscopic approach to treatment of acute necrotizing pancreatitis was substantially safer than was minimally invasive surgical treatment in a randomized study of 66 patients.
Performing drainage and necrosectomy endoscopically in 34 patients with necrotizing pancreatitis that was symptomatic, infected, or both resulted in a 12% rate of major adverse events over the 3 months following intervention compared with a 38% rate among 32 similar patients who underwent laparoscopic drainage followed by either internal debridement or video-assisted retroperitoneal debridement, Ji Young Bang, MD, said at the World Congress of Gastroenterology at ACG 2017.
This statistically significant reduction in the study’s primary endpoint was driven primarily by a major reduction in the incidence of pancreaticocutaneous fistula, which occurred in none of the endoscopy patients and in eight (25%) of the surgery patients, and a smaller reduction in enterocutaneous fistula, which occurred in none of the endoscopy patients and in four (13%) of the patients treated surgically, said Dr. Bang, a gastroenterologist at the Center for Interventional Endoscopy at Florida Hospital, Orlando.
Based on these results, the endoscopic approach “is the treatment of the future,” Dr. Bang said in a video interview. Although the randomized study had a modest number of patients, it was adequately powered to address the hypothesis that endoscopy caused fewer major adverse events than did minimally invasive surgery, and hence the findings should have “an important clinical impact” on the choice of endoscopy or a minimally invasive surgical approach. But Dr. Bang also stressed that a successful endoscopic approach as obtained in this study requires treatment at a center that can offer multidisciplinary expertise from gastrointestinal endoscopists, surgeons, and radiologists, as well as infectious disease physicians, to minimize infections.
Prior to this study, results from the Pancreatitis, Endoscopic Transgastric vs Primary Necrosectomy in Patients With Infected Necrosis (PENGUIN) study run in the Netherlands had also shown significantly fewer adverse events with endoscopic treatment compared with laparoscopic surgery in 20 randomized patients (JAMA. 2012 Mar 14;307[10]:1053-61).
The study reported by Dr. Bang, the Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) trial, enrolled patients with an average necrotic collection size of about 11 cm. The average age of the patients was 59 years. Nearly half of the patients had confirmed infected necrosis. More than 90% had American Society of Anesthesiologists class III or IV disease, and about half had systemic inflammatory response syndrome. All patients had disease that was amenable to both the endoscopic and minimally invasive surgical approaches.
The study’s primary endpoint included several other adverse events in addition to fistulas during 3-month follow-up: death, new-onset organ failure or multiple systemic dysfunction, visceral perforation, and intra-abdominal bleeding. The incidence of each of these outcomes was about the same in the two study arms.
The results also showed that endoscopy was significantly better than surgery for several other secondary outcomes, including new-onset systemic inflammatory response syndrome as well as the prevalence of this complication 3 days after intervention (21% compared with 66%), days in the ICU, average total procedure and hospitalization cost ($76,000 compared with $117,000), and physical quality of life 3 months after treatment. For all other measured outcomes the endoscopic approach and surgical approach produced similar outcomes, and no outcome measured showed that endoscopy was significantly inferior to surgery, Dr. Bang reported.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
ORLANDO – An endoscopic approach to treatment of acute necrotizing pancreatitis was substantially safer than was minimally invasive surgical treatment in a randomized study of 66 patients.
Performing drainage and necrosectomy endoscopically in 34 patients with necrotizing pancreatitis that was symptomatic, infected, or both resulted in a 12% rate of major adverse events over the 3 months following intervention compared with a 38% rate among 32 similar patients who underwent laparoscopic drainage followed by either internal debridement or video-assisted retroperitoneal debridement, Ji Young Bang, MD, said at the World Congress of Gastroenterology at ACG 2017.
This statistically significant reduction in the study’s primary endpoint was driven primarily by a major reduction in the incidence of pancreaticocutaneous fistula, which occurred in none of the endoscopy patients and in eight (25%) of the surgery patients, and a smaller reduction in enterocutaneous fistula, which occurred in none of the endoscopy patients and in four (13%) of the patients treated surgically, said Dr. Bang, a gastroenterologist at the Center for Interventional Endoscopy at Florida Hospital, Orlando.
Based on these results, the endoscopic approach “is the treatment of the future,” Dr. Bang said in a video interview. Although the randomized study had a modest number of patients, it was adequately powered to address the hypothesis that endoscopy caused fewer major adverse events than did minimally invasive surgery, and hence the findings should have “an important clinical impact” on the choice of endoscopy or a minimally invasive surgical approach. But Dr. Bang also stressed that a successful endoscopic approach as obtained in this study requires treatment at a center that can offer multidisciplinary expertise from gastrointestinal endoscopists, surgeons, and radiologists, as well as infectious disease physicians, to minimize infections.
Prior to this study, results from the Pancreatitis, Endoscopic Transgastric vs Primary Necrosectomy in Patients With Infected Necrosis (PENGUIN) study run in the Netherlands had also shown significantly fewer adverse events with endoscopic treatment compared with laparoscopic surgery in 20 randomized patients (JAMA. 2012 Mar 14;307[10]:1053-61).
The study reported by Dr. Bang, the Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) trial, enrolled patients with an average necrotic collection size of about 11 cm. The average age of the patients was 59 years. Nearly half of the patients had confirmed infected necrosis. More than 90% had American Society of Anesthesiologists class III or IV disease, and about half had systemic inflammatory response syndrome. All patients had disease that was amenable to both the endoscopic and minimally invasive surgical approaches.
The study’s primary endpoint included several other adverse events in addition to fistulas during 3-month follow-up: death, new-onset organ failure or multiple systemic dysfunction, visceral perforation, and intra-abdominal bleeding. The incidence of each of these outcomes was about the same in the two study arms.
The results also showed that endoscopy was significantly better than surgery for several other secondary outcomes, including new-onset systemic inflammatory response syndrome as well as the prevalence of this complication 3 days after intervention (21% compared with 66%), days in the ICU, average total procedure and hospitalization cost ($76,000 compared with $117,000), and physical quality of life 3 months after treatment. For all other measured outcomes the endoscopic approach and surgical approach produced similar outcomes, and no outcome measured showed that endoscopy was significantly inferior to surgery, Dr. Bang reported.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
ORLANDO – An endoscopic approach to treatment of acute necrotizing pancreatitis was substantially safer than was minimally invasive surgical treatment in a randomized study of 66 patients.
Performing drainage and necrosectomy endoscopically in 34 patients with necrotizing pancreatitis that was symptomatic, infected, or both resulted in a 12% rate of major adverse events over the 3 months following intervention compared with a 38% rate among 32 similar patients who underwent laparoscopic drainage followed by either internal debridement or video-assisted retroperitoneal debridement, Ji Young Bang, MD, said at the World Congress of Gastroenterology at ACG 2017.
This statistically significant reduction in the study’s primary endpoint was driven primarily by a major reduction in the incidence of pancreaticocutaneous fistula, which occurred in none of the endoscopy patients and in eight (25%) of the surgery patients, and a smaller reduction in enterocutaneous fistula, which occurred in none of the endoscopy patients and in four (13%) of the patients treated surgically, said Dr. Bang, a gastroenterologist at the Center for Interventional Endoscopy at Florida Hospital, Orlando.
Based on these results, the endoscopic approach “is the treatment of the future,” Dr. Bang said in a video interview. Although the randomized study had a modest number of patients, it was adequately powered to address the hypothesis that endoscopy caused fewer major adverse events than did minimally invasive surgery, and hence the findings should have “an important clinical impact” on the choice of endoscopy or a minimally invasive surgical approach. But Dr. Bang also stressed that a successful endoscopic approach as obtained in this study requires treatment at a center that can offer multidisciplinary expertise from gastrointestinal endoscopists, surgeons, and radiologists, as well as infectious disease physicians, to minimize infections.
Prior to this study, results from the Pancreatitis, Endoscopic Transgastric vs Primary Necrosectomy in Patients With Infected Necrosis (PENGUIN) study run in the Netherlands had also shown significantly fewer adverse events with endoscopic treatment compared with laparoscopic surgery in 20 randomized patients (JAMA. 2012 Mar 14;307[10]:1053-61).
The study reported by Dr. Bang, the Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) trial, enrolled patients with an average necrotic collection size of about 11 cm. The average age of the patients was 59 years. Nearly half of the patients had confirmed infected necrosis. More than 90% had American Society of Anesthesiologists class III or IV disease, and about half had systemic inflammatory response syndrome. All patients had disease that was amenable to both the endoscopic and minimally invasive surgical approaches.
The study’s primary endpoint included several other adverse events in addition to fistulas during 3-month follow-up: death, new-onset organ failure or multiple systemic dysfunction, visceral perforation, and intra-abdominal bleeding. The incidence of each of these outcomes was about the same in the two study arms.
The results also showed that endoscopy was significantly better than surgery for several other secondary outcomes, including new-onset systemic inflammatory response syndrome as well as the prevalence of this complication 3 days after intervention (21% compared with 66%), days in the ICU, average total procedure and hospitalization cost ($76,000 compared with $117,000), and physical quality of life 3 months after treatment. For all other measured outcomes the endoscopic approach and surgical approach produced similar outcomes, and no outcome measured showed that endoscopy was significantly inferior to surgery, Dr. Bang reported.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
AT THE WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: Major adverse events occurred in 12% of patients treated endoscopically and in 38% of patients treated surgically.
Data source: MISER, a multicenter randomized study of 66 evaluable patients.
Disclosures: MISER received no commercial funding. Dr. Bang had no disclosures.
MI, stroke risk from HFrEF surpasses HFpEF
DALLAS – Patients newly diagnosed with heart failure with reduced ejection fraction had about an 8% incidence of MIs during the subsequent 9 months, and a 5% incidence of ischemic strokes in a retrospective review of more than 1,600 community-dwelling U.S. patients.
The MI and ischemic stroke incidence rates in heart failure patients with reduced ejection fraction (HFrEF) were both significantly higher than in more than 4,000 patients with heart failure with preserved ejection fraction (HFpEF), Gregg C. Fonarow, MD, said while presenting a poster at the annual scientific meeting of the Heart Failure Society of America.
The findings suggest that greater attention is needed to reduce the risks for MI and stroke in HFrEF patients, suggested Dr. Fonarow, professor and cochief of cardiology at the University of California, Los Angeles, and his associates in their poster.
The study used claims data collected during July 2009-September 2016 from more than 10 million people enrolled in the United Health Group, who received care at more than 650 hospitals and about 6,600 clinics. The study included all patients diagnosed with heart failure during a hospital or emergency room visit and who had no history of a heart failure diagnosis or episode during the preceding 18 months, a left ventricular ejection fraction measurement made close to the time of the index encounter, and no stroke or MI apparent at the time of the index event. The study included 1,622 patients with HFrEF, defined as a left ventricular ejection fraction of less than 40%, 4,288 with HFpEF, defined as an ejection fraction of 50% or more, and 1,095 with heart failure with a borderline ejection fraction of 40%-49%.
The HFrEF patients had an average ejection fraction of 28%, they averaged 72 years old, 36% were women, and 8% had a prior stroke. The HFpEF patients averaged 74 years old, their average ejection fraction was 61%, 55% were women, and 11% had a prior stroke. Follow-up data on all patients were available for an average of nearly 9 months following their index heart failure event, with some patients followed as long as 1 year.
During follow-up, the incidence of ischemic stroke was 5.4% in the HFrEF patients and 3.9% in those with HFpEF, a difference that worked out to a statistically significant 40% higher ischemic stroke rate in HFrEF patients after adjustment for baseline differences between the two patient groups, Dr. Fonarow reported. The patients with a borderline ejection fraction had a 3.7% stroke incidence that fell short of a significant difference, compared with the HFrEF patient.The rate of new MIs during follow-up was 7.5% in the HFrEF patients and 3.2% in the HFpEF patients, a statistically significant 2.5-fold relatively higher MI rate with HFrEF, a statistically significant difference after adjustments. The MI incidence in patients with a borderline ejection fraction was 5.9%
[email protected]
On Twitter @mitchelzoler
DALLAS – Patients newly diagnosed with heart failure with reduced ejection fraction had about an 8% incidence of MIs during the subsequent 9 months, and a 5% incidence of ischemic strokes in a retrospective review of more than 1,600 community-dwelling U.S. patients.
The MI and ischemic stroke incidence rates in heart failure patients with reduced ejection fraction (HFrEF) were both significantly higher than in more than 4,000 patients with heart failure with preserved ejection fraction (HFpEF), Gregg C. Fonarow, MD, said while presenting a poster at the annual scientific meeting of the Heart Failure Society of America.
The findings suggest that greater attention is needed to reduce the risks for MI and stroke in HFrEF patients, suggested Dr. Fonarow, professor and cochief of cardiology at the University of California, Los Angeles, and his associates in their poster.
The study used claims data collected during July 2009-September 2016 from more than 10 million people enrolled in the United Health Group, who received care at more than 650 hospitals and about 6,600 clinics. The study included all patients diagnosed with heart failure during a hospital or emergency room visit and who had no history of a heart failure diagnosis or episode during the preceding 18 months, a left ventricular ejection fraction measurement made close to the time of the index encounter, and no stroke or MI apparent at the time of the index event. The study included 1,622 patients with HFrEF, defined as a left ventricular ejection fraction of less than 40%, 4,288 with HFpEF, defined as an ejection fraction of 50% or more, and 1,095 with heart failure with a borderline ejection fraction of 40%-49%.
The HFrEF patients had an average ejection fraction of 28%, they averaged 72 years old, 36% were women, and 8% had a prior stroke. The HFpEF patients averaged 74 years old, their average ejection fraction was 61%, 55% were women, and 11% had a prior stroke. Follow-up data on all patients were available for an average of nearly 9 months following their index heart failure event, with some patients followed as long as 1 year.
During follow-up, the incidence of ischemic stroke was 5.4% in the HFrEF patients and 3.9% in those with HFpEF, a difference that worked out to a statistically significant 40% higher ischemic stroke rate in HFrEF patients after adjustment for baseline differences between the two patient groups, Dr. Fonarow reported. The patients with a borderline ejection fraction had a 3.7% stroke incidence that fell short of a significant difference, compared with the HFrEF patient.The rate of new MIs during follow-up was 7.5% in the HFrEF patients and 3.2% in the HFpEF patients, a statistically significant 2.5-fold relatively higher MI rate with HFrEF, a statistically significant difference after adjustments. The MI incidence in patients with a borderline ejection fraction was 5.9%
[email protected]
On Twitter @mitchelzoler
DALLAS – Patients newly diagnosed with heart failure with reduced ejection fraction had about an 8% incidence of MIs during the subsequent 9 months, and a 5% incidence of ischemic strokes in a retrospective review of more than 1,600 community-dwelling U.S. patients.
The MI and ischemic stroke incidence rates in heart failure patients with reduced ejection fraction (HFrEF) were both significantly higher than in more than 4,000 patients with heart failure with preserved ejection fraction (HFpEF), Gregg C. Fonarow, MD, said while presenting a poster at the annual scientific meeting of the Heart Failure Society of America.
The findings suggest that greater attention is needed to reduce the risks for MI and stroke in HFrEF patients, suggested Dr. Fonarow, professor and cochief of cardiology at the University of California, Los Angeles, and his associates in their poster.
The study used claims data collected during July 2009-September 2016 from more than 10 million people enrolled in the United Health Group, who received care at more than 650 hospitals and about 6,600 clinics. The study included all patients diagnosed with heart failure during a hospital or emergency room visit and who had no history of a heart failure diagnosis or episode during the preceding 18 months, a left ventricular ejection fraction measurement made close to the time of the index encounter, and no stroke or MI apparent at the time of the index event. The study included 1,622 patients with HFrEF, defined as a left ventricular ejection fraction of less than 40%, 4,288 with HFpEF, defined as an ejection fraction of 50% or more, and 1,095 with heart failure with a borderline ejection fraction of 40%-49%.
The HFrEF patients had an average ejection fraction of 28%, they averaged 72 years old, 36% were women, and 8% had a prior stroke. The HFpEF patients averaged 74 years old, their average ejection fraction was 61%, 55% were women, and 11% had a prior stroke. Follow-up data on all patients were available for an average of nearly 9 months following their index heart failure event, with some patients followed as long as 1 year.
During follow-up, the incidence of ischemic stroke was 5.4% in the HFrEF patients and 3.9% in those with HFpEF, a difference that worked out to a statistically significant 40% higher ischemic stroke rate in HFrEF patients after adjustment for baseline differences between the two patient groups, Dr. Fonarow reported. The patients with a borderline ejection fraction had a 3.7% stroke incidence that fell short of a significant difference, compared with the HFrEF patient.The rate of new MIs during follow-up was 7.5% in the HFrEF patients and 3.2% in the HFpEF patients, a statistically significant 2.5-fold relatively higher MI rate with HFrEF, a statistically significant difference after adjustments. The MI incidence in patients with a borderline ejection fraction was 5.9%
[email protected]
On Twitter @mitchelzoler
AT THE HFSA ANNUAL SCIENTIFIC MEETING
Key clinical point:
Major finding: HFrEF patients had a 40% higher incidence of stroke and a 2.5-fold higher incidence of MI, compared with HFpEF patients.
Data source: Retrospective review of 7,005 U.S. patients newly diagnosed with heart failure.
Disclosures: The study was funded by Janssen. Dr. Fonarow had no relevant disclosures.
VIDEO: AF ablation boosts survival in heart failure patients
BARCELONA – In patients with heart failure with reduced ejection fraction who also have atrial fibrillation, catheter ablation of the arrhythmia produced significantly improved long-term survival and a significant reduction in heart failure hospitalizations, in results from a multicenter randomized trial with more than 350 patients.
During 5-year follow-up, heart failure patients who underwent an ablative procedure for their atrial fibrillation (AF) had a statistically significant 37% lower rate of the combined primary endpoint of all-cause death or hospitalization for worsening heart failure, compared with control patients managed by standard medical therapy, Nassir F. Marrouche, MD, said at the annual congress of the European Society of Cardiology. The results also showed significant reductions from ablation, compared with controls, for the individual secondary endpoints of all-cause mortality, heart failure hospitalizations, cardiovascular mortality, and cardiovascular hospitalizations, said Dr. Marrouche, a professor of medicine and electrophysiologist at the University of Utah in Salt Lake City.
“Catheter ablation of atrial fibrillation is already done in heart failure patients, but now we have added information that this treatment may not just improve AF symptoms but also lead to a significant improvement in prognosis,” said Johannes Brachmann, MD, a coinvestigator on the study and professor and chief of cardiology at Coburg (Germany) Hospital.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) trial was investigator initiated and run at 31 centers in nine countries. The study randomized patients with paroxysmal or persistent AF and heart failure with a left ventricular ejection fraction of 35% or less. All patients also had to have failed treatment with, been intolerant of, or refused treatment with at least one antiarrhythmic drug, and they had to have been implanted with either an implantable cardioverter defibrillator or a cardiac resynchronization therapy and defibrillation device. The researchers randomized 179 patients to catheter ablation by pulmonary vein isolation, and 184 patients to either a standard rate or rhythm-control regimen plus anticoagulation to prevent ischemic stroke.
The ablation procedure also cut the average AF burden by more than half, compared with medical therapy throughout the 5-year follow-up, Dr. Marrouche reported.
The results “support the need to monitor patients with heart failure for atrial fibrillation,” Dr. Brachmann said in a video interview. This means broader use of monitoring technologies to diagnose AF in heart failure patients, such as implanted loop recorders or implanted rhythm devices.
The prevalence of atrial fibrillation in patients with heart failure with reduced ejection fraction can run 30% or higher. In patients with NYHA class IV heart failure, the AF prevalence is about 50%, Dr. Brachmann said.
CASTLE AF was funded by Biotronik. Dr. Marrouche has been a consultant to and received research funding from Biotronik and from several other companies. Dr. Brachmann has been a speaker for and has received research funding from Biotronik and from Abbott and Medtronic.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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On Twitter @mitchelzoler
The results of several studies have shown that patients with both atrial fibrillation and heart failure have about a 40% increased mortality, compared with heart failure patients without atrial fibrillation.
Five prior randomized controlled trials assessed the impact of AF ablation, compared with rate or rhythm control, in heart failure patients. But unlike CASTLE AF, all the prior studies used freedom from AF as the primary endpoint.
Enrolled patients were symptomatic from AF. Would asymptomatic patients get the same benefits? All enrolled patients had failed prior antiarrhythmic treatment or were intolerant or unwilling to take it. Does this mean the trial enrolled patients who generally were unresponsive to antiarrhythmic drugs, thereby skewing the results toward worse outcomes in control patients? Also, the 5-week run-in period used before randomization may have shifted enrollment toward patients well suited to ablation. The enrolled patients were also relatively young (averaging 64 years of age), and about 60% were New York Heart Association functional class II. A minority had longstanding AF. Were these younger and healthier patients better able to tolerate ablation? And can centers with less experience performing ablations have similar results?
The CASTLE AF results suggest that the time has come to offer AF ablation to patients with heart failure with reduced ejection fraction and AF, but we must be careful to select patients who are similar to the ones enrolled in this trial.
Carina Blomström-Lundqvist, MD, an electrophysiologist at Uppsala (Sweden) University Hospital, made these comments as designated discussant for the report. She has received research funding from Medtronic and Cardiome, and she has received honoraria from Biotronik, Bayer, Bristol-Myers Squibb, Medtronic, Merck, Pfizer, and Sanofi.
The results of several studies have shown that patients with both atrial fibrillation and heart failure have about a 40% increased mortality, compared with heart failure patients without atrial fibrillation.
Five prior randomized controlled trials assessed the impact of AF ablation, compared with rate or rhythm control, in heart failure patients. But unlike CASTLE AF, all the prior studies used freedom from AF as the primary endpoint.
Enrolled patients were symptomatic from AF. Would asymptomatic patients get the same benefits? All enrolled patients had failed prior antiarrhythmic treatment or were intolerant or unwilling to take it. Does this mean the trial enrolled patients who generally were unresponsive to antiarrhythmic drugs, thereby skewing the results toward worse outcomes in control patients? Also, the 5-week run-in period used before randomization may have shifted enrollment toward patients well suited to ablation. The enrolled patients were also relatively young (averaging 64 years of age), and about 60% were New York Heart Association functional class II. A minority had longstanding AF. Were these younger and healthier patients better able to tolerate ablation? And can centers with less experience performing ablations have similar results?
The CASTLE AF results suggest that the time has come to offer AF ablation to patients with heart failure with reduced ejection fraction and AF, but we must be careful to select patients who are similar to the ones enrolled in this trial.
Carina Blomström-Lundqvist, MD, an electrophysiologist at Uppsala (Sweden) University Hospital, made these comments as designated discussant for the report. She has received research funding from Medtronic and Cardiome, and she has received honoraria from Biotronik, Bayer, Bristol-Myers Squibb, Medtronic, Merck, Pfizer, and Sanofi.
The results of several studies have shown that patients with both atrial fibrillation and heart failure have about a 40% increased mortality, compared with heart failure patients without atrial fibrillation.
Five prior randomized controlled trials assessed the impact of AF ablation, compared with rate or rhythm control, in heart failure patients. But unlike CASTLE AF, all the prior studies used freedom from AF as the primary endpoint.
Enrolled patients were symptomatic from AF. Would asymptomatic patients get the same benefits? All enrolled patients had failed prior antiarrhythmic treatment or were intolerant or unwilling to take it. Does this mean the trial enrolled patients who generally were unresponsive to antiarrhythmic drugs, thereby skewing the results toward worse outcomes in control patients? Also, the 5-week run-in period used before randomization may have shifted enrollment toward patients well suited to ablation. The enrolled patients were also relatively young (averaging 64 years of age), and about 60% were New York Heart Association functional class II. A minority had longstanding AF. Were these younger and healthier patients better able to tolerate ablation? And can centers with less experience performing ablations have similar results?
The CASTLE AF results suggest that the time has come to offer AF ablation to patients with heart failure with reduced ejection fraction and AF, but we must be careful to select patients who are similar to the ones enrolled in this trial.
Carina Blomström-Lundqvist, MD, an electrophysiologist at Uppsala (Sweden) University Hospital, made these comments as designated discussant for the report. She has received research funding from Medtronic and Cardiome, and she has received honoraria from Biotronik, Bayer, Bristol-Myers Squibb, Medtronic, Merck, Pfizer, and Sanofi.
BARCELONA – In patients with heart failure with reduced ejection fraction who also have atrial fibrillation, catheter ablation of the arrhythmia produced significantly improved long-term survival and a significant reduction in heart failure hospitalizations, in results from a multicenter randomized trial with more than 350 patients.
During 5-year follow-up, heart failure patients who underwent an ablative procedure for their atrial fibrillation (AF) had a statistically significant 37% lower rate of the combined primary endpoint of all-cause death or hospitalization for worsening heart failure, compared with control patients managed by standard medical therapy, Nassir F. Marrouche, MD, said at the annual congress of the European Society of Cardiology. The results also showed significant reductions from ablation, compared with controls, for the individual secondary endpoints of all-cause mortality, heart failure hospitalizations, cardiovascular mortality, and cardiovascular hospitalizations, said Dr. Marrouche, a professor of medicine and electrophysiologist at the University of Utah in Salt Lake City.
“Catheter ablation of atrial fibrillation is already done in heart failure patients, but now we have added information that this treatment may not just improve AF symptoms but also lead to a significant improvement in prognosis,” said Johannes Brachmann, MD, a coinvestigator on the study and professor and chief of cardiology at Coburg (Germany) Hospital.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) trial was investigator initiated and run at 31 centers in nine countries. The study randomized patients with paroxysmal or persistent AF and heart failure with a left ventricular ejection fraction of 35% or less. All patients also had to have failed treatment with, been intolerant of, or refused treatment with at least one antiarrhythmic drug, and they had to have been implanted with either an implantable cardioverter defibrillator or a cardiac resynchronization therapy and defibrillation device. The researchers randomized 179 patients to catheter ablation by pulmonary vein isolation, and 184 patients to either a standard rate or rhythm-control regimen plus anticoagulation to prevent ischemic stroke.
The ablation procedure also cut the average AF burden by more than half, compared with medical therapy throughout the 5-year follow-up, Dr. Marrouche reported.
The results “support the need to monitor patients with heart failure for atrial fibrillation,” Dr. Brachmann said in a video interview. This means broader use of monitoring technologies to diagnose AF in heart failure patients, such as implanted loop recorders or implanted rhythm devices.
The prevalence of atrial fibrillation in patients with heart failure with reduced ejection fraction can run 30% or higher. In patients with NYHA class IV heart failure, the AF prevalence is about 50%, Dr. Brachmann said.
CASTLE AF was funded by Biotronik. Dr. Marrouche has been a consultant to and received research funding from Biotronik and from several other companies. Dr. Brachmann has been a speaker for and has received research funding from Biotronik and from Abbott and Medtronic.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
BARCELONA – In patients with heart failure with reduced ejection fraction who also have atrial fibrillation, catheter ablation of the arrhythmia produced significantly improved long-term survival and a significant reduction in heart failure hospitalizations, in results from a multicenter randomized trial with more than 350 patients.
During 5-year follow-up, heart failure patients who underwent an ablative procedure for their atrial fibrillation (AF) had a statistically significant 37% lower rate of the combined primary endpoint of all-cause death or hospitalization for worsening heart failure, compared with control patients managed by standard medical therapy, Nassir F. Marrouche, MD, said at the annual congress of the European Society of Cardiology. The results also showed significant reductions from ablation, compared with controls, for the individual secondary endpoints of all-cause mortality, heart failure hospitalizations, cardiovascular mortality, and cardiovascular hospitalizations, said Dr. Marrouche, a professor of medicine and electrophysiologist at the University of Utah in Salt Lake City.
“Catheter ablation of atrial fibrillation is already done in heart failure patients, but now we have added information that this treatment may not just improve AF symptoms but also lead to a significant improvement in prognosis,” said Johannes Brachmann, MD, a coinvestigator on the study and professor and chief of cardiology at Coburg (Germany) Hospital.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) trial was investigator initiated and run at 31 centers in nine countries. The study randomized patients with paroxysmal or persistent AF and heart failure with a left ventricular ejection fraction of 35% or less. All patients also had to have failed treatment with, been intolerant of, or refused treatment with at least one antiarrhythmic drug, and they had to have been implanted with either an implantable cardioverter defibrillator or a cardiac resynchronization therapy and defibrillation device. The researchers randomized 179 patients to catheter ablation by pulmonary vein isolation, and 184 patients to either a standard rate or rhythm-control regimen plus anticoagulation to prevent ischemic stroke.
The ablation procedure also cut the average AF burden by more than half, compared with medical therapy throughout the 5-year follow-up, Dr. Marrouche reported.
The results “support the need to monitor patients with heart failure for atrial fibrillation,” Dr. Brachmann said in a video interview. This means broader use of monitoring technologies to diagnose AF in heart failure patients, such as implanted loop recorders or implanted rhythm devices.
The prevalence of atrial fibrillation in patients with heart failure with reduced ejection fraction can run 30% or higher. In patients with NYHA class IV heart failure, the AF prevalence is about 50%, Dr. Brachmann said.
CASTLE AF was funded by Biotronik. Dr. Marrouche has been a consultant to and received research funding from Biotronik and from several other companies. Dr. Brachmann has been a speaker for and has received research funding from Biotronik and from Abbott and Medtronic.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: AF ablation was linked to a 37% 5-year reduction in mortality and heart failure hospitalization, compared with standard treatment.
Data source: CASTLE AF, a multicenter randomized trial with 363 patients.
Disclosures: CASTLE AF was funded by Biotronik. Dr. Marrouche has been a consultant to and received research funding from Biotronik and from several other companies. Dr. Brachmann has been a speaker for and has received research funding from Biotronik and from Abbott and Medtronic.
VIDEO: Intermittent furosemide during acute HFpEF favors kidneys
DALLAS – Patients with heart failure with preserved ejection fraction who were hospitalized for acute decompensation had a significantly smaller rise in serum creatinine when treated with intermittent, bolus doses of furosemide, compared with patients who received a continuous furosemide infusion in a single-center, randomized trial with 90 patients.
Intermittent furosemide also resulted in many fewer episodes of worsening renal function. In the trial, 12% of patients who received bolus furosemide doses developed worsening renal function during hospitalization compared with 36% of patients treated with a continuous furosemide infusion, Kavita Sharma, MD, said at the annual scientific meeting of the Heart Failure Society of America.
While acknowledging that this finding is preliminary because it was made in a relatively small, single-center study, “I’d be cautious about continuous infusion” in acute decompensated patients with heart failure with preserved ejection fraction (HFpEF); “bolus is preferred,” Dr. Sharma said in a video interview.
Results from the prior Diuretic Optimization Strategies Evaluation (DOSE) trial, published in 2011, had shown no significant difference in renal function in hospitalized heart failure patients randomized to receive either bolus or continuous furosemide, but that study largely enrolled patients with heart failure with reduced ejection fraction (HFrEF) (N Engl J Med. 2011 Mar 3;364[9]:797-805).
“When patients with HFpEF are hospitalized with acute heart failure there is a high rate of kidney injury, that often results in slowing diuresis leading to longer hospital stays. With adjustment for changes in blood pressure and volume of diuresis we saw a fourfold increase in worsening renal failure [with continuous infusion], so you should think twice before using continuous dosing,” said Dr. Sharma, a heart failure cardiologist at Johns Hopkins Medicine in Baltimore.
She presented results from Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction (ROPA-DOP), which randomized 90 hospitalized heart failure patients with a left ventricular ejection fraction of at least 50% and an estimated glomerular filtration rate of more than 15 mL/min/1.73 m2. The enrolled patients averaged 66 years old, 61% were women, their average body mass index was 41 kg/m2, and their average estimated glomerular filtration rate was 58 mL/min/1.73 m2.
The study’s primary endpoint was percent change in creatinine during hospitalization, which rose by an average 5% in the patients who received intermittent bolus furosemide and by an average 16% in patient who received a continuous infusion, a statistically significant difference. In a regression analysis that controlled for between-group differences in patient’s age, sex, race, body mass index, smoking status, changes in systolic blood pressure, heart rate, fluid balance after 72 hours, and other variables, patients treated with continuous furosemide infusion averaged an 11% greater increase in serum creatinine, Dr. Sharma reported. After similar adjustments, the secondary endpoint rate of worsening renal function was more than four times more likely to occur in the patients on continuous infusion compared with those who received intermittent bolus treatment, she said.
A second aspect of the ROPA-DOP trial randomized the same patients to received either low dose (3 mcg/kg per min) dopamine or placebo during hospitalization. The results showed that low-dose dopamine had no significant impact on either change in creatinine levels or on the incidence of worsening renal function compared with placebo, though dopamine treatment did link with a nonsignificant trend toward somewhat greater diuresis. These results were consistent with prior findings in the Renal Optimization Strategies Evaluation (ROSE) trial (JAMA. 2013 Nov 18;310[23]:2533-43), which used a mixed population of patients with HFpEF or HFrEF but predominantly patients with HFrEF, Dr. Sharma noted.
“It was a neutral finding [for dopamine in ROPA-DOP], and while there was no harm from dopamine there was clearly no benefit,” she said. It is possible that HFpEF patients with right ventricular dysfunction secondary to pulmonary hypertension might benefit from low-dose dopamine, but this needs further study, Dr. Sharma said.
[email protected]
On Twitter @mitchelzoler
In the Diuretic Optimization Strategies Evaluation (DOSE) trial, we enrolled heart failure patients with a mix of reduced ejection fraction and preserved ejection fraction. The DOSE results showed no relationship between ejection fraction and the response to furosemide treatment by intermittent bolus or by continuous infusion in patients hospitalized with acute decompensated heart failure. The results also showed that continuous infusion was no better than intermittent bolus treatment, and following our report in 2011 (N Engl J Med. 2011 Mar 3;364[9]:797-805), many centers that had previously relied on continuous furosemide switched to use of bolus doses primarily because continuous infusion is much less convenient.
But it is important to keep in mind that trial results focus on averages and populations of patients. Anecdotally, we see some acute heart failure patients who seem to respond better to continuous infusion, and so some clinicians switch patients who do not respond well to bolus treatment to continuous infusion. In DOSE, we only tested the efficacy of the initial strategy; we have no evidence on whether or not changing the dosing strategy helps patients who do not respond adequately to an initial strategy of intermittent bolus doses.
G. Michael Felker, MD , professor of medicine at Duke University, Durham, N.C., made these comments in an interview. He has been a consultant to Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, MyoKardia, Novartis, Stealth, and Trevena.
In the Diuretic Optimization Strategies Evaluation (DOSE) trial, we enrolled heart failure patients with a mix of reduced ejection fraction and preserved ejection fraction. The DOSE results showed no relationship between ejection fraction and the response to furosemide treatment by intermittent bolus or by continuous infusion in patients hospitalized with acute decompensated heart failure. The results also showed that continuous infusion was no better than intermittent bolus treatment, and following our report in 2011 (N Engl J Med. 2011 Mar 3;364[9]:797-805), many centers that had previously relied on continuous furosemide switched to use of bolus doses primarily because continuous infusion is much less convenient.
But it is important to keep in mind that trial results focus on averages and populations of patients. Anecdotally, we see some acute heart failure patients who seem to respond better to continuous infusion, and so some clinicians switch patients who do not respond well to bolus treatment to continuous infusion. In DOSE, we only tested the efficacy of the initial strategy; we have no evidence on whether or not changing the dosing strategy helps patients who do not respond adequately to an initial strategy of intermittent bolus doses.
G. Michael Felker, MD , professor of medicine at Duke University, Durham, N.C., made these comments in an interview. He has been a consultant to Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, MyoKardia, Novartis, Stealth, and Trevena.
In the Diuretic Optimization Strategies Evaluation (DOSE) trial, we enrolled heart failure patients with a mix of reduced ejection fraction and preserved ejection fraction. The DOSE results showed no relationship between ejection fraction and the response to furosemide treatment by intermittent bolus or by continuous infusion in patients hospitalized with acute decompensated heart failure. The results also showed that continuous infusion was no better than intermittent bolus treatment, and following our report in 2011 (N Engl J Med. 2011 Mar 3;364[9]:797-805), many centers that had previously relied on continuous furosemide switched to use of bolus doses primarily because continuous infusion is much less convenient.
But it is important to keep in mind that trial results focus on averages and populations of patients. Anecdotally, we see some acute heart failure patients who seem to respond better to continuous infusion, and so some clinicians switch patients who do not respond well to bolus treatment to continuous infusion. In DOSE, we only tested the efficacy of the initial strategy; we have no evidence on whether or not changing the dosing strategy helps patients who do not respond adequately to an initial strategy of intermittent bolus doses.
G. Michael Felker, MD , professor of medicine at Duke University, Durham, N.C., made these comments in an interview. He has been a consultant to Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, MyoKardia, Novartis, Stealth, and Trevena.
DALLAS – Patients with heart failure with preserved ejection fraction who were hospitalized for acute decompensation had a significantly smaller rise in serum creatinine when treated with intermittent, bolus doses of furosemide, compared with patients who received a continuous furosemide infusion in a single-center, randomized trial with 90 patients.
Intermittent furosemide also resulted in many fewer episodes of worsening renal function. In the trial, 12% of patients who received bolus furosemide doses developed worsening renal function during hospitalization compared with 36% of patients treated with a continuous furosemide infusion, Kavita Sharma, MD, said at the annual scientific meeting of the Heart Failure Society of America.
While acknowledging that this finding is preliminary because it was made in a relatively small, single-center study, “I’d be cautious about continuous infusion” in acute decompensated patients with heart failure with preserved ejection fraction (HFpEF); “bolus is preferred,” Dr. Sharma said in a video interview.
Results from the prior Diuretic Optimization Strategies Evaluation (DOSE) trial, published in 2011, had shown no significant difference in renal function in hospitalized heart failure patients randomized to receive either bolus or continuous furosemide, but that study largely enrolled patients with heart failure with reduced ejection fraction (HFrEF) (N Engl J Med. 2011 Mar 3;364[9]:797-805).
“When patients with HFpEF are hospitalized with acute heart failure there is a high rate of kidney injury, that often results in slowing diuresis leading to longer hospital stays. With adjustment for changes in blood pressure and volume of diuresis we saw a fourfold increase in worsening renal failure [with continuous infusion], so you should think twice before using continuous dosing,” said Dr. Sharma, a heart failure cardiologist at Johns Hopkins Medicine in Baltimore.
She presented results from Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction (ROPA-DOP), which randomized 90 hospitalized heart failure patients with a left ventricular ejection fraction of at least 50% and an estimated glomerular filtration rate of more than 15 mL/min/1.73 m2. The enrolled patients averaged 66 years old, 61% were women, their average body mass index was 41 kg/m2, and their average estimated glomerular filtration rate was 58 mL/min/1.73 m2.
The study’s primary endpoint was percent change in creatinine during hospitalization, which rose by an average 5% in the patients who received intermittent bolus furosemide and by an average 16% in patient who received a continuous infusion, a statistically significant difference. In a regression analysis that controlled for between-group differences in patient’s age, sex, race, body mass index, smoking status, changes in systolic blood pressure, heart rate, fluid balance after 72 hours, and other variables, patients treated with continuous furosemide infusion averaged an 11% greater increase in serum creatinine, Dr. Sharma reported. After similar adjustments, the secondary endpoint rate of worsening renal function was more than four times more likely to occur in the patients on continuous infusion compared with those who received intermittent bolus treatment, she said.
A second aspect of the ROPA-DOP trial randomized the same patients to received either low dose (3 mcg/kg per min) dopamine or placebo during hospitalization. The results showed that low-dose dopamine had no significant impact on either change in creatinine levels or on the incidence of worsening renal function compared with placebo, though dopamine treatment did link with a nonsignificant trend toward somewhat greater diuresis. These results were consistent with prior findings in the Renal Optimization Strategies Evaluation (ROSE) trial (JAMA. 2013 Nov 18;310[23]:2533-43), which used a mixed population of patients with HFpEF or HFrEF but predominantly patients with HFrEF, Dr. Sharma noted.
“It was a neutral finding [for dopamine in ROPA-DOP], and while there was no harm from dopamine there was clearly no benefit,” she said. It is possible that HFpEF patients with right ventricular dysfunction secondary to pulmonary hypertension might benefit from low-dose dopamine, but this needs further study, Dr. Sharma said.
[email protected]
On Twitter @mitchelzoler
DALLAS – Patients with heart failure with preserved ejection fraction who were hospitalized for acute decompensation had a significantly smaller rise in serum creatinine when treated with intermittent, bolus doses of furosemide, compared with patients who received a continuous furosemide infusion in a single-center, randomized trial with 90 patients.
Intermittent furosemide also resulted in many fewer episodes of worsening renal function. In the trial, 12% of patients who received bolus furosemide doses developed worsening renal function during hospitalization compared with 36% of patients treated with a continuous furosemide infusion, Kavita Sharma, MD, said at the annual scientific meeting of the Heart Failure Society of America.
While acknowledging that this finding is preliminary because it was made in a relatively small, single-center study, “I’d be cautious about continuous infusion” in acute decompensated patients with heart failure with preserved ejection fraction (HFpEF); “bolus is preferred,” Dr. Sharma said in a video interview.
Results from the prior Diuretic Optimization Strategies Evaluation (DOSE) trial, published in 2011, had shown no significant difference in renal function in hospitalized heart failure patients randomized to receive either bolus or continuous furosemide, but that study largely enrolled patients with heart failure with reduced ejection fraction (HFrEF) (N Engl J Med. 2011 Mar 3;364[9]:797-805).
“When patients with HFpEF are hospitalized with acute heart failure there is a high rate of kidney injury, that often results in slowing diuresis leading to longer hospital stays. With adjustment for changes in blood pressure and volume of diuresis we saw a fourfold increase in worsening renal failure [with continuous infusion], so you should think twice before using continuous dosing,” said Dr. Sharma, a heart failure cardiologist at Johns Hopkins Medicine in Baltimore.
She presented results from Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction (ROPA-DOP), which randomized 90 hospitalized heart failure patients with a left ventricular ejection fraction of at least 50% and an estimated glomerular filtration rate of more than 15 mL/min/1.73 m2. The enrolled patients averaged 66 years old, 61% were women, their average body mass index was 41 kg/m2, and their average estimated glomerular filtration rate was 58 mL/min/1.73 m2.
The study’s primary endpoint was percent change in creatinine during hospitalization, which rose by an average 5% in the patients who received intermittent bolus furosemide and by an average 16% in patient who received a continuous infusion, a statistically significant difference. In a regression analysis that controlled for between-group differences in patient’s age, sex, race, body mass index, smoking status, changes in systolic blood pressure, heart rate, fluid balance after 72 hours, and other variables, patients treated with continuous furosemide infusion averaged an 11% greater increase in serum creatinine, Dr. Sharma reported. After similar adjustments, the secondary endpoint rate of worsening renal function was more than four times more likely to occur in the patients on continuous infusion compared with those who received intermittent bolus treatment, she said.
A second aspect of the ROPA-DOP trial randomized the same patients to received either low dose (3 mcg/kg per min) dopamine or placebo during hospitalization. The results showed that low-dose dopamine had no significant impact on either change in creatinine levels or on the incidence of worsening renal function compared with placebo, though dopamine treatment did link with a nonsignificant trend toward somewhat greater diuresis. These results were consistent with prior findings in the Renal Optimization Strategies Evaluation (ROSE) trial (JAMA. 2013 Nov 18;310[23]:2533-43), which used a mixed population of patients with HFpEF or HFrEF but predominantly patients with HFrEF, Dr. Sharma noted.
“It was a neutral finding [for dopamine in ROPA-DOP], and while there was no harm from dopamine there was clearly no benefit,” she said. It is possible that HFpEF patients with right ventricular dysfunction secondary to pulmonary hypertension might benefit from low-dose dopamine, but this needs further study, Dr. Sharma said.
[email protected]
On Twitter @mitchelzoler
AT THE HFSA ANNUAL SCIENTIFIC MEETING
Key clinical point:
Major finding: Serum creatinine rose by an average 5% with intermittent bolus furosemide and by 16% with continuous infusion.
Data source: ROPA-DOP, a single-center randomized trial with 90 patients.
Disclosures: Dr. Sharma had no disclosures.