User login
Cardiac arrests peak with pollution in Japan
PHILADELPHIA – Out-of-hospital cardiac arrests spike with daily counts of emissions-related particulate matter – a key contributor to urban smog – and particularly affect men and people older than age 75, according to results of a nationwide Japanese study presented at the American Heart Association scientific sessions.
“Short-term exposure to particulate pollutants is a potential trigger for cardiac-origin, out-of-hospital cardiac arrest [OHCA] onset in Japan,” said Sunao Kojima, MD, a professor at Kawasaki Medical School in Kurashiki, Japan.
The study used the All-Japan Utstein Registry of OHCA throughout all 47 prefectures in Japan. The analysis then applied prefecture-specific estimates of PM2.5 – particulate matter that measures 2.5 mcm in average diameter – using a time-stratified, case-crossover design. By comparison, PM2.5 is about 1/40th the diameter of human hair (approximately 100 mcm) and about 1/12th that of cedar pollen (30 mcm).
“Increased OHCAs incidence correlated with the average increase in PM2.5 concentrations over those observed 1 day before cardiac arrest,” Dr. Kojima said.
What’s noteworthy about the Utstein registry, Dr. Kojima said, is that emergency medical service personnel in Japan are not authorized to terminate resuscitation efforts, so most OHCA patients are transported to the nearest hospital and are thus counted in the registry.
From a total count of 1.4 million EMS-assessed OHCAs from 2005 through 2016, the study focused on 103,189 bystander-witnessed events from April 2011 through 2016. The analysis further divided that population into three groups: those presenting with initial ventricular fibrillation/pulseless ventricular tachycardia (20,848); those without initial VF/pulseless VT (80,110); and those with initial cardiac rhythm of unknown origin (2,231).
“The pathways linking PM2.5 exposure with OHCA remain unknown, but several mechanisms have been suspected,” Dr. Kojima said. “A major mechanism is thought to be associated with oxidative stress and systemic inflammation.”
The average daily concentration for PM2.5 was 13.9/m3 across all of Japan, Dr. Kojima said, with the highest concentrations in western Japan (16.3/m3). A 10-mcg/m3 increase in the average PM2.5 concentrations on the day of OHCA from the previous day (lag 0-1) was associated with a 1.6% increase in OHCAs (95% confidence interval, 0.1-3.1%), he said.
“Increased PM2.5 concentrations were closely associated with OHCA incidence, even when adjusted for other pollutants, such as ozone, nitrogen dioxide, sulfur dioxide, and lag 0-1,” Dr. Kojima said.
The incidence for PM2.5-related OHCA was higher for people age 75 and older and for men, during the warm season and in the central region. In the central region, the incidence increased around 6% for every 10-mcg/m3 day-to-day increase in the average PM2.5 compared to less than 1% increases in the eastern and western regions, Dr. Kojima said.
PM2.5 levels also seemed to influence outcomes depending on the origin of the OHCA, he said. Patients with VF/pulseless VT and pulseless electrical activity had better outcomes than did those with asystole. Increased PM2.5 levels were linked with lower rates of restoration of spontaneous circulation, 1-month survival, and 1-month survival with minimal neurological impairment, he said. Patients who had chest-compression-only CPR seemed to do significantly better than did those who had chest compression with rescue breathing, he said.
“There may be room for further discussion regarding the impact of performing rescue breathing in CPR and the consequent effects of short-term PM2.5 exposure on patients with cardiac origin,” he said.
Dr. Kojima has no financial relationships to disclose. The study received funding from the Japan Ministry of the Environment, Japan Society for the Promotion of Science, and Foundation for Total Health Promotion, Japan.
SOURCE: Kojima S. AHA 2019, Session FS.AOS.F1.
PHILADELPHIA – Out-of-hospital cardiac arrests spike with daily counts of emissions-related particulate matter – a key contributor to urban smog – and particularly affect men and people older than age 75, according to results of a nationwide Japanese study presented at the American Heart Association scientific sessions.
“Short-term exposure to particulate pollutants is a potential trigger for cardiac-origin, out-of-hospital cardiac arrest [OHCA] onset in Japan,” said Sunao Kojima, MD, a professor at Kawasaki Medical School in Kurashiki, Japan.
The study used the All-Japan Utstein Registry of OHCA throughout all 47 prefectures in Japan. The analysis then applied prefecture-specific estimates of PM2.5 – particulate matter that measures 2.5 mcm in average diameter – using a time-stratified, case-crossover design. By comparison, PM2.5 is about 1/40th the diameter of human hair (approximately 100 mcm) and about 1/12th that of cedar pollen (30 mcm).
“Increased OHCAs incidence correlated with the average increase in PM2.5 concentrations over those observed 1 day before cardiac arrest,” Dr. Kojima said.
What’s noteworthy about the Utstein registry, Dr. Kojima said, is that emergency medical service personnel in Japan are not authorized to terminate resuscitation efforts, so most OHCA patients are transported to the nearest hospital and are thus counted in the registry.
From a total count of 1.4 million EMS-assessed OHCAs from 2005 through 2016, the study focused on 103,189 bystander-witnessed events from April 2011 through 2016. The analysis further divided that population into three groups: those presenting with initial ventricular fibrillation/pulseless ventricular tachycardia (20,848); those without initial VF/pulseless VT (80,110); and those with initial cardiac rhythm of unknown origin (2,231).
“The pathways linking PM2.5 exposure with OHCA remain unknown, but several mechanisms have been suspected,” Dr. Kojima said. “A major mechanism is thought to be associated with oxidative stress and systemic inflammation.”
The average daily concentration for PM2.5 was 13.9/m3 across all of Japan, Dr. Kojima said, with the highest concentrations in western Japan (16.3/m3). A 10-mcg/m3 increase in the average PM2.5 concentrations on the day of OHCA from the previous day (lag 0-1) was associated with a 1.6% increase in OHCAs (95% confidence interval, 0.1-3.1%), he said.
“Increased PM2.5 concentrations were closely associated with OHCA incidence, even when adjusted for other pollutants, such as ozone, nitrogen dioxide, sulfur dioxide, and lag 0-1,” Dr. Kojima said.
The incidence for PM2.5-related OHCA was higher for people age 75 and older and for men, during the warm season and in the central region. In the central region, the incidence increased around 6% for every 10-mcg/m3 day-to-day increase in the average PM2.5 compared to less than 1% increases in the eastern and western regions, Dr. Kojima said.
PM2.5 levels also seemed to influence outcomes depending on the origin of the OHCA, he said. Patients with VF/pulseless VT and pulseless electrical activity had better outcomes than did those with asystole. Increased PM2.5 levels were linked with lower rates of restoration of spontaneous circulation, 1-month survival, and 1-month survival with minimal neurological impairment, he said. Patients who had chest-compression-only CPR seemed to do significantly better than did those who had chest compression with rescue breathing, he said.
“There may be room for further discussion regarding the impact of performing rescue breathing in CPR and the consequent effects of short-term PM2.5 exposure on patients with cardiac origin,” he said.
Dr. Kojima has no financial relationships to disclose. The study received funding from the Japan Ministry of the Environment, Japan Society for the Promotion of Science, and Foundation for Total Health Promotion, Japan.
SOURCE: Kojima S. AHA 2019, Session FS.AOS.F1.
PHILADELPHIA – Out-of-hospital cardiac arrests spike with daily counts of emissions-related particulate matter – a key contributor to urban smog – and particularly affect men and people older than age 75, according to results of a nationwide Japanese study presented at the American Heart Association scientific sessions.
“Short-term exposure to particulate pollutants is a potential trigger for cardiac-origin, out-of-hospital cardiac arrest [OHCA] onset in Japan,” said Sunao Kojima, MD, a professor at Kawasaki Medical School in Kurashiki, Japan.
The study used the All-Japan Utstein Registry of OHCA throughout all 47 prefectures in Japan. The analysis then applied prefecture-specific estimates of PM2.5 – particulate matter that measures 2.5 mcm in average diameter – using a time-stratified, case-crossover design. By comparison, PM2.5 is about 1/40th the diameter of human hair (approximately 100 mcm) and about 1/12th that of cedar pollen (30 mcm).
“Increased OHCAs incidence correlated with the average increase in PM2.5 concentrations over those observed 1 day before cardiac arrest,” Dr. Kojima said.
What’s noteworthy about the Utstein registry, Dr. Kojima said, is that emergency medical service personnel in Japan are not authorized to terminate resuscitation efforts, so most OHCA patients are transported to the nearest hospital and are thus counted in the registry.
From a total count of 1.4 million EMS-assessed OHCAs from 2005 through 2016, the study focused on 103,189 bystander-witnessed events from April 2011 through 2016. The analysis further divided that population into three groups: those presenting with initial ventricular fibrillation/pulseless ventricular tachycardia (20,848); those without initial VF/pulseless VT (80,110); and those with initial cardiac rhythm of unknown origin (2,231).
“The pathways linking PM2.5 exposure with OHCA remain unknown, but several mechanisms have been suspected,” Dr. Kojima said. “A major mechanism is thought to be associated with oxidative stress and systemic inflammation.”
The average daily concentration for PM2.5 was 13.9/m3 across all of Japan, Dr. Kojima said, with the highest concentrations in western Japan (16.3/m3). A 10-mcg/m3 increase in the average PM2.5 concentrations on the day of OHCA from the previous day (lag 0-1) was associated with a 1.6% increase in OHCAs (95% confidence interval, 0.1-3.1%), he said.
“Increased PM2.5 concentrations were closely associated with OHCA incidence, even when adjusted for other pollutants, such as ozone, nitrogen dioxide, sulfur dioxide, and lag 0-1,” Dr. Kojima said.
The incidence for PM2.5-related OHCA was higher for people age 75 and older and for men, during the warm season and in the central region. In the central region, the incidence increased around 6% for every 10-mcg/m3 day-to-day increase in the average PM2.5 compared to less than 1% increases in the eastern and western regions, Dr. Kojima said.
PM2.5 levels also seemed to influence outcomes depending on the origin of the OHCA, he said. Patients with VF/pulseless VT and pulseless electrical activity had better outcomes than did those with asystole. Increased PM2.5 levels were linked with lower rates of restoration of spontaneous circulation, 1-month survival, and 1-month survival with minimal neurological impairment, he said. Patients who had chest-compression-only CPR seemed to do significantly better than did those who had chest compression with rescue breathing, he said.
“There may be room for further discussion regarding the impact of performing rescue breathing in CPR and the consequent effects of short-term PM2.5 exposure on patients with cardiac origin,” he said.
Dr. Kojima has no financial relationships to disclose. The study received funding from the Japan Ministry of the Environment, Japan Society for the Promotion of Science, and Foundation for Total Health Promotion, Japan.
SOURCE: Kojima S. AHA 2019, Session FS.AOS.F1.
REPORTING FROM AHA 2019
Icosapent ethyl cost effective in REDUCE-IT analysis
PHILADELPHIA – The overall costs of icosapent ethyl were less than placebo, and the medication reduced cardiovascular events by 30% at a cost that fits well within acceptable quality-adjusted life-year (QALY) parameters, according to a cost-effectiveness analysis of the REDUCE-IT trial.
Days before the presentation of the analysis at the American Heart Association scientific sessions, a Food and Drug Administration advisory panel unanimously recommended approval of icosapent ethyl (Vascepa) for a new indication for reducing CV event risk. Icosapent ethyl, a highly purified form of the ethyl ester of eicosapentaenoic acid derived from fish oil, received FDA approval in 2012 for treatment of triglyceride levels of at least 500 mg/dL.
“What we found here is that icosapent ethyl is a dominant strategy,” said William S. Weintraub, MD, director of outcomes research at MedStar Heart & Vascular Institute in Washington, in reporting preliminary cost-analysis findings from REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl – Intervention Trial). “It’s offering better outcomes at a lower cost.”
The dominant strategy was demonstrated by cost savings in 70% of simulations the cost-effectiveness analysis ran, Dr. Weintraub said.
“These are very impressive results,” said session moderator Seth S. Martin, MD, an internist and cardiologist at Johns Hopkins University, Baltimore. “We don’t often see dominant strategies for new drugs. This is very exciting.”
“Almost never,” Dr. Weintraub responded.
REDUCE-IT randomized 8,179 patients with a diagnosis of CVD or with diabetes and other risk factors who had been on statins and had triglycerides of 135-499 mg/dL to either 4 g of icosapent ethyl daily or placebo (N Engl J Med. 2019;380:11-22). Trial results showed the treatment group had an absolute risk reduction of 4.8% and a relative risk reduction of 25% of first CV events and a 30% relative risk reduction for total events, Dr. Weintraub said.
The analysis determined that the QALYs for icosapent ethyl versus those for placebo were 3.34 and 3.27, respectively, during the trial period and 11.61 and 11.35 over a lifetime. The mean costs for the two treatments were $27,576 and $28,205 during the trial period and $235,352 and $236,636 lifetime, respectively, Dr. Weintraub said.
An analysis of cost effectiveness showed that almost all of the estimates fell below the willingness-to-pay (WTP) threshold of $50,000 per QALY gained, Dr. Weintraub said. “In fact, some 70% plus are in what’s called quadrant two; that is, decreased cost and increased efficacy.”
The analysis also calculated the value of icosapent ethyl at three different WTP thresholds: up to $6 a day at a WTP of $50,000, up to $12 a day at $100,000, and up to $18 a day at $150,000. The analysis used the actual net pricing of $4.16 a day, Dr. Weintraub said. “That’s why we showed we have the dominant strategy,” he said.
Further cost-effectiveness analyses of the REDUCE-IT data will focus on subgroups, such as U.S. and non–U.S. patients and people with diabetes. He also emphasized the data he reported were preliminary. “We have a lot more work to do,” Dr. Weintraub said.
Dr. Weintraub reported having financial relationships with Amarin Pharma, which markets Vascepa, and AstraZeneca.
SOURCE: Weintraub WS. AHA 2019, Session FS.AOS.F1.
PHILADELPHIA – The overall costs of icosapent ethyl were less than placebo, and the medication reduced cardiovascular events by 30% at a cost that fits well within acceptable quality-adjusted life-year (QALY) parameters, according to a cost-effectiveness analysis of the REDUCE-IT trial.
Days before the presentation of the analysis at the American Heart Association scientific sessions, a Food and Drug Administration advisory panel unanimously recommended approval of icosapent ethyl (Vascepa) for a new indication for reducing CV event risk. Icosapent ethyl, a highly purified form of the ethyl ester of eicosapentaenoic acid derived from fish oil, received FDA approval in 2012 for treatment of triglyceride levels of at least 500 mg/dL.
“What we found here is that icosapent ethyl is a dominant strategy,” said William S. Weintraub, MD, director of outcomes research at MedStar Heart & Vascular Institute in Washington, in reporting preliminary cost-analysis findings from REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl – Intervention Trial). “It’s offering better outcomes at a lower cost.”
The dominant strategy was demonstrated by cost savings in 70% of simulations the cost-effectiveness analysis ran, Dr. Weintraub said.
“These are very impressive results,” said session moderator Seth S. Martin, MD, an internist and cardiologist at Johns Hopkins University, Baltimore. “We don’t often see dominant strategies for new drugs. This is very exciting.”
“Almost never,” Dr. Weintraub responded.
REDUCE-IT randomized 8,179 patients with a diagnosis of CVD or with diabetes and other risk factors who had been on statins and had triglycerides of 135-499 mg/dL to either 4 g of icosapent ethyl daily or placebo (N Engl J Med. 2019;380:11-22). Trial results showed the treatment group had an absolute risk reduction of 4.8% and a relative risk reduction of 25% of first CV events and a 30% relative risk reduction for total events, Dr. Weintraub said.
The analysis determined that the QALYs for icosapent ethyl versus those for placebo were 3.34 and 3.27, respectively, during the trial period and 11.61 and 11.35 over a lifetime. The mean costs for the two treatments were $27,576 and $28,205 during the trial period and $235,352 and $236,636 lifetime, respectively, Dr. Weintraub said.
An analysis of cost effectiveness showed that almost all of the estimates fell below the willingness-to-pay (WTP) threshold of $50,000 per QALY gained, Dr. Weintraub said. “In fact, some 70% plus are in what’s called quadrant two; that is, decreased cost and increased efficacy.”
The analysis also calculated the value of icosapent ethyl at three different WTP thresholds: up to $6 a day at a WTP of $50,000, up to $12 a day at $100,000, and up to $18 a day at $150,000. The analysis used the actual net pricing of $4.16 a day, Dr. Weintraub said. “That’s why we showed we have the dominant strategy,” he said.
Further cost-effectiveness analyses of the REDUCE-IT data will focus on subgroups, such as U.S. and non–U.S. patients and people with diabetes. He also emphasized the data he reported were preliminary. “We have a lot more work to do,” Dr. Weintraub said.
Dr. Weintraub reported having financial relationships with Amarin Pharma, which markets Vascepa, and AstraZeneca.
SOURCE: Weintraub WS. AHA 2019, Session FS.AOS.F1.
PHILADELPHIA – The overall costs of icosapent ethyl were less than placebo, and the medication reduced cardiovascular events by 30% at a cost that fits well within acceptable quality-adjusted life-year (QALY) parameters, according to a cost-effectiveness analysis of the REDUCE-IT trial.
Days before the presentation of the analysis at the American Heart Association scientific sessions, a Food and Drug Administration advisory panel unanimously recommended approval of icosapent ethyl (Vascepa) for a new indication for reducing CV event risk. Icosapent ethyl, a highly purified form of the ethyl ester of eicosapentaenoic acid derived from fish oil, received FDA approval in 2012 for treatment of triglyceride levels of at least 500 mg/dL.
“What we found here is that icosapent ethyl is a dominant strategy,” said William S. Weintraub, MD, director of outcomes research at MedStar Heart & Vascular Institute in Washington, in reporting preliminary cost-analysis findings from REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl – Intervention Trial). “It’s offering better outcomes at a lower cost.”
The dominant strategy was demonstrated by cost savings in 70% of simulations the cost-effectiveness analysis ran, Dr. Weintraub said.
“These are very impressive results,” said session moderator Seth S. Martin, MD, an internist and cardiologist at Johns Hopkins University, Baltimore. “We don’t often see dominant strategies for new drugs. This is very exciting.”
“Almost never,” Dr. Weintraub responded.
REDUCE-IT randomized 8,179 patients with a diagnosis of CVD or with diabetes and other risk factors who had been on statins and had triglycerides of 135-499 mg/dL to either 4 g of icosapent ethyl daily or placebo (N Engl J Med. 2019;380:11-22). Trial results showed the treatment group had an absolute risk reduction of 4.8% and a relative risk reduction of 25% of first CV events and a 30% relative risk reduction for total events, Dr. Weintraub said.
The analysis determined that the QALYs for icosapent ethyl versus those for placebo were 3.34 and 3.27, respectively, during the trial period and 11.61 and 11.35 over a lifetime. The mean costs for the two treatments were $27,576 and $28,205 during the trial period and $235,352 and $236,636 lifetime, respectively, Dr. Weintraub said.
An analysis of cost effectiveness showed that almost all of the estimates fell below the willingness-to-pay (WTP) threshold of $50,000 per QALY gained, Dr. Weintraub said. “In fact, some 70% plus are in what’s called quadrant two; that is, decreased cost and increased efficacy.”
The analysis also calculated the value of icosapent ethyl at three different WTP thresholds: up to $6 a day at a WTP of $50,000, up to $12 a day at $100,000, and up to $18 a day at $150,000. The analysis used the actual net pricing of $4.16 a day, Dr. Weintraub said. “That’s why we showed we have the dominant strategy,” he said.
Further cost-effectiveness analyses of the REDUCE-IT data will focus on subgroups, such as U.S. and non–U.S. patients and people with diabetes. He also emphasized the data he reported were preliminary. “We have a lot more work to do,” Dr. Weintraub said.
Dr. Weintraub reported having financial relationships with Amarin Pharma, which markets Vascepa, and AstraZeneca.
SOURCE: Weintraub WS. AHA 2019, Session FS.AOS.F1.
REPORTING FROM AHA 2019
GALILEO, GALILEO 4D: Mixed results in post-TAVR anticoagulation
PHILADELPHIA – The results of the first randomized prospective trial of an anticoagulation strategy versus standard dual antiplatelet (DAPT) therapy for patients undergoing transcatheter aortic valve replacement (TAVR) show that routine anticoagulation is not suitable for all comers in a high-risk population.
In the main GALILEO trial of elderly patients after TAVR, those who received an investigational anticoagulation strategy with the direct factor Xa inhibitor rivaroxaban (Xarelto; Bayer/Janssen) had worse survival and more thromboembolic and bleeding events than patients who received standard DAPT.
However, in the GALILEO 4D substudy of patients who underwent four-dimensional computed tomography (4DCT) randomized to the two therapies, those in the rivaroxaban arm were less likely to show subclinical leaflet motion abnormalities and leaflet thickening.
Preliminary results from GALILEO were disclosed in an October 3, 2018, “Dear Healthcare Professional” letter from Bayer, and the trial was stopped after a median of 17 months due to safety concerns.
The full data analysis from GALILEO as well as the results from GALILEO 4D were presented at the American Heart Association scientific sessions to coincide with their publication on Nov. 16, 2019, in the New England Journal of Medicine.
The takeaway message is that, despite the positive imaging finding in GALILEO 4D, “there is no reason to give 10 mg rivaroxaban-based treatment routinely after TAVR in patients who don’t need anticoagulation anyhow,” lead author in the main GALILEO trial, George D. Dangas, MD, PhD, Mount Sinai Hospital, New York, said in an interview.
However, because rivaroxaban had an effect in reducing the clots on leaflets, he said, further investigation is required to determine the optimal therapeutic strategy after TAVR.
Similarly, the assigned discussant for GALILEO, Elaine Hylek, MD, of Boston University said in an interview that “we just don’t know right now what the overall added benefit of an oral anticoagulant would be in this high-risk patient population after having a TAVR.”
Ole De Backer, MD, PhD, of Rigshospitalet University Hospital, Copenhagen, lead author of the GALILEO 4D substudy, concluded that, although the rivaroxaban-based strategy was associated with fewer valve abnormalities in this analysis, those positive outcomes need to be taken in context with worse clinical outcomes in the main GALILEO trial.
GALILEO
Guidelines recommend DAPT after TAVR, but this advice is based on expert consensus or small studies, the GALILEO study authors noted. Several years ago, there were random case reports and then case series of patients who had undergone TAVR or surgical aortic valve replacement (SAVR) and developed clots around the valve, Dr. Dangas explained.
These developments coincided with the first available high-quality CT angiography images that captured valve abnormalities that had not been seen before.
In parallel, there were rare reports of stroke and transient ischemic attack (TIA) that may have been associated with TAVR or SAVR. This triggered a series of studies to investigate an anticoagulation strategy after TAVR.
From December 2015 to May 2018, GALILEO enrolled 1,644 patients at 136 sites in 16 countries who had undergone successful TAVR, and had no indication for an anticoagulant (e.g., no atrial fibrillation).
The patients had a mean age of 80.6 years (plus or minus 6.6 years) and 49.5% were female. The median time from TAVR to randomization was 2 days (range, 0-8 days).
Half were randomized to receive an antithrombotic strategy, rivaroxaban 10 mg once daily plus aspirin 75-100 mg once daily for the first 90 days followed by rivaroxaban alone. The other half received an antiplatelet-based strategy, aspirin 75-100 mg once daily plus clopidogrel 75 mg once daily for the first 90 days followed by aspirin alone.
In the intention-to-treat analysis, death or first thromboembolic event, the primary efficacy outcome, occurred in 105 patients in the rivaroxaban group and 78 patients in the antiplatelet group (hazard ratio, 1.35; 95% CI, 1.01-1.81; P = .04).
Major, disabling, or life-threatening bleeding, the primary safety outcome, occurred in 46 and 31 patients, respectively (HR, 1.50; P = .08).
A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (HR, 1.69; 95% CI, 1.13-2.53).
The individuals who were enrolled in this study were 80 and older, Dr. Hylek pointed out. “The age in and of itself is an uncontested risk factor for everything, whether it be bleeding, embolic event, or obviously mortality.”
Although the dose was half that used to prevent stroke in patients with atrial fibrillation, perhaps a “twice-daily lower dose” might be the way to go, moving forward, she said.
Patients who did not have atrial fibrillation may have developed atrial fibrillation in the interim, and “you would have to change the dose of the rivaroxaban.”
Also, patients who may have been taking aspirin for 5 or 10 years and “survived” aspirin, who were then newly exposed to an anticoagulant, would be more likely to experience bleeding.
“I certainly wouldn’t close the door on novel anticoagulants,” she concluded. “There are still other drug trials that are out there with this TAVR population. We’ll wait for that,” and see if the results corroborate these findings.
The high-risk patients may turn out to be a potential niche group for drugs being developed to inhibit factor XIa, she speculated.
GALILEO 4D
However, despite the negative results of the overall GALILEO study, results from the substudy that used 4DCT to evaluate function of the bioprosthetic aortic valves suggested rivaroxaban may have potentially beneficial effects on valve function.
The results showed that patients on the rivaroxaban and aspirin regimen had lower rates of subclinical reduced leaflet motion and leaflet thickening than patients on the antiplatelet strategy, said Dr. De Backer, reporting on behalf of the GALILEO-4D investigators.
The substudy evaluated 205 patients who had 4DCT 90 days after TAVR. The primary substudy endpoint was at least one prosthetic valve leaflet with a grade 3 or higher motion reduction, which 2 of 97 patients in the rivaroxaban group had (2.1%) versus 11 of 101 in the antiplatelet group (10.9%, P = .01).
“This indicated an 80% greater reduction of the primary endpoint in the rivaroxaban arm,” Dr. De Backer said. The chief secondary endpoint, the proportion of patients with at least one thickened leaflet, was met by 12.4% of the rivaroxaban group and 32.4% of the antiplatelet arm, “a 60% significant reduction by rivaroxaban,” Dr. De Backer said.
However, when the 10 patients in each group who didn’t adhere to the study drug regimen were excluded, he said, “then we see no single patient had reduced leaflet motion of grade 3 or more in the rivaroxaban arm.”
Another takeaway from the substudy is the ineffectiveness of transthoracic echocardiography as opposed to 4DCT in TAVR patients. Echocardiography (ECG) failed to show any significant differences in the mean valve gradient between the treatment groups, Dr. De Backer said.
Eleven patients who didn’t have leaflet thickening (7.3%) and 7 patients who did (15.9%) showed an increase of 5 mm Hg or more in the mean valve gradient on echo. ECG also showed a similar increase in the mean valve gradient in 14 patients who had no to moderate reduced leaflet motion (grade 3 or lower, 7.7%) and in four patients (30.8) who had grade 3 or higher reduced leaflet motion.
“This basically confirms results from observational studies that transthoracic echocardiography is often not good enough to detect these phenomena,” Dr. De Backer said.
The percentages of substudy patients who had major clinical events – major bleeding, thromboembolic events, or death at 90 days – were each less than 3%, he said. “There were too few clinical events to permit any assessment of the impact of leaflet thickening or reduced leaflet motion on clinical outcomes,” he said.
That lack of clarity with regard to clinical events is one of the questions the study leaves unanswered, said discussant Victoria Delgado, MD, PhD, of Leiden University Medical Center in the Netherlands.
“With stroke or TIA, there are too few events to draw any conclusions,” she said of the substudy. “We don’t know when we need to use CT, when we need to evaluate these patients, or maybe when we should go for more advanced imaging techniques where we can see the biology of those changes in the leaflets.” Hopefully, she said, future studies provide those insights.
“CT can be more sensitive than ECG to see these subclinical changes,” she said, “but the open questions that we have are to see if there is a correlation between thrombosis rate on imaging versus the stroke rate.”
The substudy’s conclusion on ECG, however, has been borne out by previous retrospective studies, Dr. Delgado added.
Robert A. Harrington, MD, of Stanford Medicine, tried to put the seemingly conflicting findings of the main GALILEO study and the 4D substudy into context.
“There you have the disconnect between the mechanism and the clinical observation and those are sometimes difficult to reconcile because the assumption is that the mechanism leads to the clinical outcome.”
While the main study shows that routine anticoagulation after TAVR is not indicated, the findings raise questions about the risk of clots forming on bioprosthetic valves. “Yes, maybe there are clots forming on these valves, but maybe that’s not causing the bad clinical outcomes,” Dr. Harrington said.
The findings also raise questions about the use of newer anticoagulants to prevent stroke post TAVR, he said. “It appears that warfarin is better than the newer anticoagulants for reasons that aren’t entirely clear.”
Dr. Dangas, lead author of the main GALILEO trial, said the substudy results could help design future trials of even-lower doses of anticoagulation in a more selective group of TAVR patients.
“In order to decrease the clots, first of all you don’t need the full dose of anticoagulation; even a low dose may do the trick,” he said. Further investigations can evaluate the clinical significance of having a blood clot in the valve as an indication for anticoagulation versus antiplatelet therapy.
“Even though this obviously doesn’t mean you’re going to have a stroke in a year or two,” Dr. Dangas said, “could it perhaps mean that the valve is not going to have such a good durability later on?”
Perhaps future studies of anticoagulation in TAVR should concentrate on patients who actually have clotting in the valve, he said.
The trial was supported by Bayer and Janssen. Dr. Dangas reported receiving grants from Bayer during the conduct of the study, personal fees from Bayer and Janssen, grants and personal fees from Daiichi-Sankyo, and “other” funding from Medtronic outside the submitted work. Dr. De Backer reported receiving grants from Bayer during the conduct of the study and personal fees from Abbott and Boston Scientific outside the submitted work.
SOURCE: Dangas GD and De Backer O. AHA 19, Late-Breaking Science 3 session.
This article also appears on Medscape.com.
PHILADELPHIA – The results of the first randomized prospective trial of an anticoagulation strategy versus standard dual antiplatelet (DAPT) therapy for patients undergoing transcatheter aortic valve replacement (TAVR) show that routine anticoagulation is not suitable for all comers in a high-risk population.
In the main GALILEO trial of elderly patients after TAVR, those who received an investigational anticoagulation strategy with the direct factor Xa inhibitor rivaroxaban (Xarelto; Bayer/Janssen) had worse survival and more thromboembolic and bleeding events than patients who received standard DAPT.
However, in the GALILEO 4D substudy of patients who underwent four-dimensional computed tomography (4DCT) randomized to the two therapies, those in the rivaroxaban arm were less likely to show subclinical leaflet motion abnormalities and leaflet thickening.
Preliminary results from GALILEO were disclosed in an October 3, 2018, “Dear Healthcare Professional” letter from Bayer, and the trial was stopped after a median of 17 months due to safety concerns.
The full data analysis from GALILEO as well as the results from GALILEO 4D were presented at the American Heart Association scientific sessions to coincide with their publication on Nov. 16, 2019, in the New England Journal of Medicine.
The takeaway message is that, despite the positive imaging finding in GALILEO 4D, “there is no reason to give 10 mg rivaroxaban-based treatment routinely after TAVR in patients who don’t need anticoagulation anyhow,” lead author in the main GALILEO trial, George D. Dangas, MD, PhD, Mount Sinai Hospital, New York, said in an interview.
However, because rivaroxaban had an effect in reducing the clots on leaflets, he said, further investigation is required to determine the optimal therapeutic strategy after TAVR.
Similarly, the assigned discussant for GALILEO, Elaine Hylek, MD, of Boston University said in an interview that “we just don’t know right now what the overall added benefit of an oral anticoagulant would be in this high-risk patient population after having a TAVR.”
Ole De Backer, MD, PhD, of Rigshospitalet University Hospital, Copenhagen, lead author of the GALILEO 4D substudy, concluded that, although the rivaroxaban-based strategy was associated with fewer valve abnormalities in this analysis, those positive outcomes need to be taken in context with worse clinical outcomes in the main GALILEO trial.
GALILEO
Guidelines recommend DAPT after TAVR, but this advice is based on expert consensus or small studies, the GALILEO study authors noted. Several years ago, there were random case reports and then case series of patients who had undergone TAVR or surgical aortic valve replacement (SAVR) and developed clots around the valve, Dr. Dangas explained.
These developments coincided with the first available high-quality CT angiography images that captured valve abnormalities that had not been seen before.
In parallel, there were rare reports of stroke and transient ischemic attack (TIA) that may have been associated with TAVR or SAVR. This triggered a series of studies to investigate an anticoagulation strategy after TAVR.
From December 2015 to May 2018, GALILEO enrolled 1,644 patients at 136 sites in 16 countries who had undergone successful TAVR, and had no indication for an anticoagulant (e.g., no atrial fibrillation).
The patients had a mean age of 80.6 years (plus or minus 6.6 years) and 49.5% were female. The median time from TAVR to randomization was 2 days (range, 0-8 days).
Half were randomized to receive an antithrombotic strategy, rivaroxaban 10 mg once daily plus aspirin 75-100 mg once daily for the first 90 days followed by rivaroxaban alone. The other half received an antiplatelet-based strategy, aspirin 75-100 mg once daily plus clopidogrel 75 mg once daily for the first 90 days followed by aspirin alone.
In the intention-to-treat analysis, death or first thromboembolic event, the primary efficacy outcome, occurred in 105 patients in the rivaroxaban group and 78 patients in the antiplatelet group (hazard ratio, 1.35; 95% CI, 1.01-1.81; P = .04).
Major, disabling, or life-threatening bleeding, the primary safety outcome, occurred in 46 and 31 patients, respectively (HR, 1.50; P = .08).
A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (HR, 1.69; 95% CI, 1.13-2.53).
The individuals who were enrolled in this study were 80 and older, Dr. Hylek pointed out. “The age in and of itself is an uncontested risk factor for everything, whether it be bleeding, embolic event, or obviously mortality.”
Although the dose was half that used to prevent stroke in patients with atrial fibrillation, perhaps a “twice-daily lower dose” might be the way to go, moving forward, she said.
Patients who did not have atrial fibrillation may have developed atrial fibrillation in the interim, and “you would have to change the dose of the rivaroxaban.”
Also, patients who may have been taking aspirin for 5 or 10 years and “survived” aspirin, who were then newly exposed to an anticoagulant, would be more likely to experience bleeding.
“I certainly wouldn’t close the door on novel anticoagulants,” she concluded. “There are still other drug trials that are out there with this TAVR population. We’ll wait for that,” and see if the results corroborate these findings.
The high-risk patients may turn out to be a potential niche group for drugs being developed to inhibit factor XIa, she speculated.
GALILEO 4D
However, despite the negative results of the overall GALILEO study, results from the substudy that used 4DCT to evaluate function of the bioprosthetic aortic valves suggested rivaroxaban may have potentially beneficial effects on valve function.
The results showed that patients on the rivaroxaban and aspirin regimen had lower rates of subclinical reduced leaflet motion and leaflet thickening than patients on the antiplatelet strategy, said Dr. De Backer, reporting on behalf of the GALILEO-4D investigators.
The substudy evaluated 205 patients who had 4DCT 90 days after TAVR. The primary substudy endpoint was at least one prosthetic valve leaflet with a grade 3 or higher motion reduction, which 2 of 97 patients in the rivaroxaban group had (2.1%) versus 11 of 101 in the antiplatelet group (10.9%, P = .01).
“This indicated an 80% greater reduction of the primary endpoint in the rivaroxaban arm,” Dr. De Backer said. The chief secondary endpoint, the proportion of patients with at least one thickened leaflet, was met by 12.4% of the rivaroxaban group and 32.4% of the antiplatelet arm, “a 60% significant reduction by rivaroxaban,” Dr. De Backer said.
However, when the 10 patients in each group who didn’t adhere to the study drug regimen were excluded, he said, “then we see no single patient had reduced leaflet motion of grade 3 or more in the rivaroxaban arm.”
Another takeaway from the substudy is the ineffectiveness of transthoracic echocardiography as opposed to 4DCT in TAVR patients. Echocardiography (ECG) failed to show any significant differences in the mean valve gradient between the treatment groups, Dr. De Backer said.
Eleven patients who didn’t have leaflet thickening (7.3%) and 7 patients who did (15.9%) showed an increase of 5 mm Hg or more in the mean valve gradient on echo. ECG also showed a similar increase in the mean valve gradient in 14 patients who had no to moderate reduced leaflet motion (grade 3 or lower, 7.7%) and in four patients (30.8) who had grade 3 or higher reduced leaflet motion.
“This basically confirms results from observational studies that transthoracic echocardiography is often not good enough to detect these phenomena,” Dr. De Backer said.
The percentages of substudy patients who had major clinical events – major bleeding, thromboembolic events, or death at 90 days – were each less than 3%, he said. “There were too few clinical events to permit any assessment of the impact of leaflet thickening or reduced leaflet motion on clinical outcomes,” he said.
That lack of clarity with regard to clinical events is one of the questions the study leaves unanswered, said discussant Victoria Delgado, MD, PhD, of Leiden University Medical Center in the Netherlands.
“With stroke or TIA, there are too few events to draw any conclusions,” she said of the substudy. “We don’t know when we need to use CT, when we need to evaluate these patients, or maybe when we should go for more advanced imaging techniques where we can see the biology of those changes in the leaflets.” Hopefully, she said, future studies provide those insights.
“CT can be more sensitive than ECG to see these subclinical changes,” she said, “but the open questions that we have are to see if there is a correlation between thrombosis rate on imaging versus the stroke rate.”
The substudy’s conclusion on ECG, however, has been borne out by previous retrospective studies, Dr. Delgado added.
Robert A. Harrington, MD, of Stanford Medicine, tried to put the seemingly conflicting findings of the main GALILEO study and the 4D substudy into context.
“There you have the disconnect between the mechanism and the clinical observation and those are sometimes difficult to reconcile because the assumption is that the mechanism leads to the clinical outcome.”
While the main study shows that routine anticoagulation after TAVR is not indicated, the findings raise questions about the risk of clots forming on bioprosthetic valves. “Yes, maybe there are clots forming on these valves, but maybe that’s not causing the bad clinical outcomes,” Dr. Harrington said.
The findings also raise questions about the use of newer anticoagulants to prevent stroke post TAVR, he said. “It appears that warfarin is better than the newer anticoagulants for reasons that aren’t entirely clear.”
Dr. Dangas, lead author of the main GALILEO trial, said the substudy results could help design future trials of even-lower doses of anticoagulation in a more selective group of TAVR patients.
“In order to decrease the clots, first of all you don’t need the full dose of anticoagulation; even a low dose may do the trick,” he said. Further investigations can evaluate the clinical significance of having a blood clot in the valve as an indication for anticoagulation versus antiplatelet therapy.
“Even though this obviously doesn’t mean you’re going to have a stroke in a year or two,” Dr. Dangas said, “could it perhaps mean that the valve is not going to have such a good durability later on?”
Perhaps future studies of anticoagulation in TAVR should concentrate on patients who actually have clotting in the valve, he said.
The trial was supported by Bayer and Janssen. Dr. Dangas reported receiving grants from Bayer during the conduct of the study, personal fees from Bayer and Janssen, grants and personal fees from Daiichi-Sankyo, and “other” funding from Medtronic outside the submitted work. Dr. De Backer reported receiving grants from Bayer during the conduct of the study and personal fees from Abbott and Boston Scientific outside the submitted work.
SOURCE: Dangas GD and De Backer O. AHA 19, Late-Breaking Science 3 session.
This article also appears on Medscape.com.
PHILADELPHIA – The results of the first randomized prospective trial of an anticoagulation strategy versus standard dual antiplatelet (DAPT) therapy for patients undergoing transcatheter aortic valve replacement (TAVR) show that routine anticoagulation is not suitable for all comers in a high-risk population.
In the main GALILEO trial of elderly patients after TAVR, those who received an investigational anticoagulation strategy with the direct factor Xa inhibitor rivaroxaban (Xarelto; Bayer/Janssen) had worse survival and more thromboembolic and bleeding events than patients who received standard DAPT.
However, in the GALILEO 4D substudy of patients who underwent four-dimensional computed tomography (4DCT) randomized to the two therapies, those in the rivaroxaban arm were less likely to show subclinical leaflet motion abnormalities and leaflet thickening.
Preliminary results from GALILEO were disclosed in an October 3, 2018, “Dear Healthcare Professional” letter from Bayer, and the trial was stopped after a median of 17 months due to safety concerns.
The full data analysis from GALILEO as well as the results from GALILEO 4D were presented at the American Heart Association scientific sessions to coincide with their publication on Nov. 16, 2019, in the New England Journal of Medicine.
The takeaway message is that, despite the positive imaging finding in GALILEO 4D, “there is no reason to give 10 mg rivaroxaban-based treatment routinely after TAVR in patients who don’t need anticoagulation anyhow,” lead author in the main GALILEO trial, George D. Dangas, MD, PhD, Mount Sinai Hospital, New York, said in an interview.
However, because rivaroxaban had an effect in reducing the clots on leaflets, he said, further investigation is required to determine the optimal therapeutic strategy after TAVR.
Similarly, the assigned discussant for GALILEO, Elaine Hylek, MD, of Boston University said in an interview that “we just don’t know right now what the overall added benefit of an oral anticoagulant would be in this high-risk patient population after having a TAVR.”
Ole De Backer, MD, PhD, of Rigshospitalet University Hospital, Copenhagen, lead author of the GALILEO 4D substudy, concluded that, although the rivaroxaban-based strategy was associated with fewer valve abnormalities in this analysis, those positive outcomes need to be taken in context with worse clinical outcomes in the main GALILEO trial.
GALILEO
Guidelines recommend DAPT after TAVR, but this advice is based on expert consensus or small studies, the GALILEO study authors noted. Several years ago, there were random case reports and then case series of patients who had undergone TAVR or surgical aortic valve replacement (SAVR) and developed clots around the valve, Dr. Dangas explained.
These developments coincided with the first available high-quality CT angiography images that captured valve abnormalities that had not been seen before.
In parallel, there were rare reports of stroke and transient ischemic attack (TIA) that may have been associated with TAVR or SAVR. This triggered a series of studies to investigate an anticoagulation strategy after TAVR.
From December 2015 to May 2018, GALILEO enrolled 1,644 patients at 136 sites in 16 countries who had undergone successful TAVR, and had no indication for an anticoagulant (e.g., no atrial fibrillation).
The patients had a mean age of 80.6 years (plus or minus 6.6 years) and 49.5% were female. The median time from TAVR to randomization was 2 days (range, 0-8 days).
Half were randomized to receive an antithrombotic strategy, rivaroxaban 10 mg once daily plus aspirin 75-100 mg once daily for the first 90 days followed by rivaroxaban alone. The other half received an antiplatelet-based strategy, aspirin 75-100 mg once daily plus clopidogrel 75 mg once daily for the first 90 days followed by aspirin alone.
In the intention-to-treat analysis, death or first thromboembolic event, the primary efficacy outcome, occurred in 105 patients in the rivaroxaban group and 78 patients in the antiplatelet group (hazard ratio, 1.35; 95% CI, 1.01-1.81; P = .04).
Major, disabling, or life-threatening bleeding, the primary safety outcome, occurred in 46 and 31 patients, respectively (HR, 1.50; P = .08).
A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (HR, 1.69; 95% CI, 1.13-2.53).
The individuals who were enrolled in this study were 80 and older, Dr. Hylek pointed out. “The age in and of itself is an uncontested risk factor for everything, whether it be bleeding, embolic event, or obviously mortality.”
Although the dose was half that used to prevent stroke in patients with atrial fibrillation, perhaps a “twice-daily lower dose” might be the way to go, moving forward, she said.
Patients who did not have atrial fibrillation may have developed atrial fibrillation in the interim, and “you would have to change the dose of the rivaroxaban.”
Also, patients who may have been taking aspirin for 5 or 10 years and “survived” aspirin, who were then newly exposed to an anticoagulant, would be more likely to experience bleeding.
“I certainly wouldn’t close the door on novel anticoagulants,” she concluded. “There are still other drug trials that are out there with this TAVR population. We’ll wait for that,” and see if the results corroborate these findings.
The high-risk patients may turn out to be a potential niche group for drugs being developed to inhibit factor XIa, she speculated.
GALILEO 4D
However, despite the negative results of the overall GALILEO study, results from the substudy that used 4DCT to evaluate function of the bioprosthetic aortic valves suggested rivaroxaban may have potentially beneficial effects on valve function.
The results showed that patients on the rivaroxaban and aspirin regimen had lower rates of subclinical reduced leaflet motion and leaflet thickening than patients on the antiplatelet strategy, said Dr. De Backer, reporting on behalf of the GALILEO-4D investigators.
The substudy evaluated 205 patients who had 4DCT 90 days after TAVR. The primary substudy endpoint was at least one prosthetic valve leaflet with a grade 3 or higher motion reduction, which 2 of 97 patients in the rivaroxaban group had (2.1%) versus 11 of 101 in the antiplatelet group (10.9%, P = .01).
“This indicated an 80% greater reduction of the primary endpoint in the rivaroxaban arm,” Dr. De Backer said. The chief secondary endpoint, the proportion of patients with at least one thickened leaflet, was met by 12.4% of the rivaroxaban group and 32.4% of the antiplatelet arm, “a 60% significant reduction by rivaroxaban,” Dr. De Backer said.
However, when the 10 patients in each group who didn’t adhere to the study drug regimen were excluded, he said, “then we see no single patient had reduced leaflet motion of grade 3 or more in the rivaroxaban arm.”
Another takeaway from the substudy is the ineffectiveness of transthoracic echocardiography as opposed to 4DCT in TAVR patients. Echocardiography (ECG) failed to show any significant differences in the mean valve gradient between the treatment groups, Dr. De Backer said.
Eleven patients who didn’t have leaflet thickening (7.3%) and 7 patients who did (15.9%) showed an increase of 5 mm Hg or more in the mean valve gradient on echo. ECG also showed a similar increase in the mean valve gradient in 14 patients who had no to moderate reduced leaflet motion (grade 3 or lower, 7.7%) and in four patients (30.8) who had grade 3 or higher reduced leaflet motion.
“This basically confirms results from observational studies that transthoracic echocardiography is often not good enough to detect these phenomena,” Dr. De Backer said.
The percentages of substudy patients who had major clinical events – major bleeding, thromboembolic events, or death at 90 days – were each less than 3%, he said. “There were too few clinical events to permit any assessment of the impact of leaflet thickening or reduced leaflet motion on clinical outcomes,” he said.
That lack of clarity with regard to clinical events is one of the questions the study leaves unanswered, said discussant Victoria Delgado, MD, PhD, of Leiden University Medical Center in the Netherlands.
“With stroke or TIA, there are too few events to draw any conclusions,” she said of the substudy. “We don’t know when we need to use CT, when we need to evaluate these patients, or maybe when we should go for more advanced imaging techniques where we can see the biology of those changes in the leaflets.” Hopefully, she said, future studies provide those insights.
“CT can be more sensitive than ECG to see these subclinical changes,” she said, “but the open questions that we have are to see if there is a correlation between thrombosis rate on imaging versus the stroke rate.”
The substudy’s conclusion on ECG, however, has been borne out by previous retrospective studies, Dr. Delgado added.
Robert A. Harrington, MD, of Stanford Medicine, tried to put the seemingly conflicting findings of the main GALILEO study and the 4D substudy into context.
“There you have the disconnect between the mechanism and the clinical observation and those are sometimes difficult to reconcile because the assumption is that the mechanism leads to the clinical outcome.”
While the main study shows that routine anticoagulation after TAVR is not indicated, the findings raise questions about the risk of clots forming on bioprosthetic valves. “Yes, maybe there are clots forming on these valves, but maybe that’s not causing the bad clinical outcomes,” Dr. Harrington said.
The findings also raise questions about the use of newer anticoagulants to prevent stroke post TAVR, he said. “It appears that warfarin is better than the newer anticoagulants for reasons that aren’t entirely clear.”
Dr. Dangas, lead author of the main GALILEO trial, said the substudy results could help design future trials of even-lower doses of anticoagulation in a more selective group of TAVR patients.
“In order to decrease the clots, first of all you don’t need the full dose of anticoagulation; even a low dose may do the trick,” he said. Further investigations can evaluate the clinical significance of having a blood clot in the valve as an indication for anticoagulation versus antiplatelet therapy.
“Even though this obviously doesn’t mean you’re going to have a stroke in a year or two,” Dr. Dangas said, “could it perhaps mean that the valve is not going to have such a good durability later on?”
Perhaps future studies of anticoagulation in TAVR should concentrate on patients who actually have clotting in the valve, he said.
The trial was supported by Bayer and Janssen. Dr. Dangas reported receiving grants from Bayer during the conduct of the study, personal fees from Bayer and Janssen, grants and personal fees from Daiichi-Sankyo, and “other” funding from Medtronic outside the submitted work. Dr. De Backer reported receiving grants from Bayer during the conduct of the study and personal fees from Abbott and Boston Scientific outside the submitted work.
SOURCE: Dangas GD and De Backer O. AHA 19, Late-Breaking Science 3 session.
This article also appears on Medscape.com.
REPORTING FROM AHA 2019
Weaknesses exposed in valsartan recall
ED visits for hypertension in month after the 2018 recall spiked 55%
PHILADELPHIA – The 2018 recall of generic forms of the antihypertensive valsartan exposed weaknesses in the recall systems for generic drugs in both the United States and Canada that caused many patients on the drug to fall through the cracks, according to a study of prescribing patterns in Ontario before and after the recall reported at the American Heart Association scientific sessions.
The results also have been published online in the journal Circulation (2019 Nov 11. doi: 10.1161/CIRCULATIONAHA.119.044494).
Cynthia Jackevicius, PharmD, of the Western University of Health Sciences in Pomona, Calif., reported that 90% of patients on recalled generic valsartan products switched to another antihypertension drug, but called the 10% for whom the study had no data “concerning.” She also said that ED visits for hypertension (HTN) in the month after the recall spiked 55%, from a rate of 0.11% to 0.17% (P = .02). While small, that increase was statistically significant, she said.
The Food and Drug Administration and Health Canada issued voluntary recalls of generic forms of valsartan in July 2018 following reports of N-nitrosodimethylamine (NDMA), a suspected carcinogen, being found in the products. Eventually, the recalls expanded to include valsartan products containing the contaminants N-nitrosodiethylamine (NDEA) and N-nitroso-N-methyl-4-aminobutyric acid (NMBA), as well as losartan and irbesartan products.
The Ontario study evaluated prescribing patterns and health system utilization in four different provincewide health databases and involved 55,461 patients, all of whom were on recalled generic valsartan when Health Canada issued the recall. The study also computed monthly rates of ED visits and hospitalizations for HTN, congestive heart failure, stroke/transit ischemic attack, and MI as primary diagnoses for 18 months before and 6 months after the recall. Rates of utilization for CHF and MI remained relatively flat through the study period, Dr. Jackevicius said, but rates of ED visits for stroke/TIA showed “a very small relative increase: 6% and 8% in ED visits and hospitalizations, respectively.” Respective P values were .020 and .037.
As for the nature of the ED visits after the recall, Dr. Jackevicius said the study did not tease that out. Many visits could have been for uncontrolled HTN or to get expired prescriptions refilled.
“But either way, even if it is just getting a new prescription, this isn’t the best response,” she said. We need to have a better system where patients can more easily or with less burden deal with a recall.”
Session moderator Seth S. Martin, MD, MHS, of Johns Hopkins University in Baltimore, echoed Dr. Jackevicius’s concerns about the handling of drug recalls. “Recalls are increasing,” he said. “Is this just the tip of the iceberg on the quality of generics and we’re going to see these floodgates open? Is this going to be chaos or is this more isolated to this class of medication, the ARBs? This is becoming a little concerning.”
Dr. Jackevicius made note of the recalls that followed the original valsartan recall.
“This really opened a lot of questions in terms of the quality of generic products,” she said. Drug manufacturers are putting safeguards into place to detect these potential contaminants, she said, “but a lot more work needs to be done to ensure the supply. All of these recalls and the prominence of this will be increased.”
The response to the recalls also must undergo revision, she said, citing the experiences of the United States and Canada. “There isn’t really a good system or strategy for recalls in either country,” Dr. Jackevicius said, noting that regulatory bodies notify prescribers and physicians, but “they don’t know which patients are on it.”
A better strategy would be to involve pharmacies more in the process. “The pharmacies have the lot numbers, and they will know what patients are on the recalled drug,” she said. “The pharmacists are the ones who are making the changes in the drugs, and giving them the responsibility so patients don’t have to go into the ED is important. If it’s a basic interchange of a drug, the pharmacists can do that to help raise compliance.”
Dr. Jackevicius had no relevant relationships to disclose.
SOURCE: Jackevicius J. AHA 2019. Session FS.AOS.F1.
ED visits for hypertension in month after the 2018 recall spiked 55%
ED visits for hypertension in month after the 2018 recall spiked 55%
PHILADELPHIA – The 2018 recall of generic forms of the antihypertensive valsartan exposed weaknesses in the recall systems for generic drugs in both the United States and Canada that caused many patients on the drug to fall through the cracks, according to a study of prescribing patterns in Ontario before and after the recall reported at the American Heart Association scientific sessions.
The results also have been published online in the journal Circulation (2019 Nov 11. doi: 10.1161/CIRCULATIONAHA.119.044494).
Cynthia Jackevicius, PharmD, of the Western University of Health Sciences in Pomona, Calif., reported that 90% of patients on recalled generic valsartan products switched to another antihypertension drug, but called the 10% for whom the study had no data “concerning.” She also said that ED visits for hypertension (HTN) in the month after the recall spiked 55%, from a rate of 0.11% to 0.17% (P = .02). While small, that increase was statistically significant, she said.
The Food and Drug Administration and Health Canada issued voluntary recalls of generic forms of valsartan in July 2018 following reports of N-nitrosodimethylamine (NDMA), a suspected carcinogen, being found in the products. Eventually, the recalls expanded to include valsartan products containing the contaminants N-nitrosodiethylamine (NDEA) and N-nitroso-N-methyl-4-aminobutyric acid (NMBA), as well as losartan and irbesartan products.
The Ontario study evaluated prescribing patterns and health system utilization in four different provincewide health databases and involved 55,461 patients, all of whom were on recalled generic valsartan when Health Canada issued the recall. The study also computed monthly rates of ED visits and hospitalizations for HTN, congestive heart failure, stroke/transit ischemic attack, and MI as primary diagnoses for 18 months before and 6 months after the recall. Rates of utilization for CHF and MI remained relatively flat through the study period, Dr. Jackevicius said, but rates of ED visits for stroke/TIA showed “a very small relative increase: 6% and 8% in ED visits and hospitalizations, respectively.” Respective P values were .020 and .037.
As for the nature of the ED visits after the recall, Dr. Jackevicius said the study did not tease that out. Many visits could have been for uncontrolled HTN or to get expired prescriptions refilled.
“But either way, even if it is just getting a new prescription, this isn’t the best response,” she said. We need to have a better system where patients can more easily or with less burden deal with a recall.”
Session moderator Seth S. Martin, MD, MHS, of Johns Hopkins University in Baltimore, echoed Dr. Jackevicius’s concerns about the handling of drug recalls. “Recalls are increasing,” he said. “Is this just the tip of the iceberg on the quality of generics and we’re going to see these floodgates open? Is this going to be chaos or is this more isolated to this class of medication, the ARBs? This is becoming a little concerning.”
Dr. Jackevicius made note of the recalls that followed the original valsartan recall.
“This really opened a lot of questions in terms of the quality of generic products,” she said. Drug manufacturers are putting safeguards into place to detect these potential contaminants, she said, “but a lot more work needs to be done to ensure the supply. All of these recalls and the prominence of this will be increased.”
The response to the recalls also must undergo revision, she said, citing the experiences of the United States and Canada. “There isn’t really a good system or strategy for recalls in either country,” Dr. Jackevicius said, noting that regulatory bodies notify prescribers and physicians, but “they don’t know which patients are on it.”
A better strategy would be to involve pharmacies more in the process. “The pharmacies have the lot numbers, and they will know what patients are on the recalled drug,” she said. “The pharmacists are the ones who are making the changes in the drugs, and giving them the responsibility so patients don’t have to go into the ED is important. If it’s a basic interchange of a drug, the pharmacists can do that to help raise compliance.”
Dr. Jackevicius had no relevant relationships to disclose.
SOURCE: Jackevicius J. AHA 2019. Session FS.AOS.F1.
PHILADELPHIA – The 2018 recall of generic forms of the antihypertensive valsartan exposed weaknesses in the recall systems for generic drugs in both the United States and Canada that caused many patients on the drug to fall through the cracks, according to a study of prescribing patterns in Ontario before and after the recall reported at the American Heart Association scientific sessions.
The results also have been published online in the journal Circulation (2019 Nov 11. doi: 10.1161/CIRCULATIONAHA.119.044494).
Cynthia Jackevicius, PharmD, of the Western University of Health Sciences in Pomona, Calif., reported that 90% of patients on recalled generic valsartan products switched to another antihypertension drug, but called the 10% for whom the study had no data “concerning.” She also said that ED visits for hypertension (HTN) in the month after the recall spiked 55%, from a rate of 0.11% to 0.17% (P = .02). While small, that increase was statistically significant, she said.
The Food and Drug Administration and Health Canada issued voluntary recalls of generic forms of valsartan in July 2018 following reports of N-nitrosodimethylamine (NDMA), a suspected carcinogen, being found in the products. Eventually, the recalls expanded to include valsartan products containing the contaminants N-nitrosodiethylamine (NDEA) and N-nitroso-N-methyl-4-aminobutyric acid (NMBA), as well as losartan and irbesartan products.
The Ontario study evaluated prescribing patterns and health system utilization in four different provincewide health databases and involved 55,461 patients, all of whom were on recalled generic valsartan when Health Canada issued the recall. The study also computed monthly rates of ED visits and hospitalizations for HTN, congestive heart failure, stroke/transit ischemic attack, and MI as primary diagnoses for 18 months before and 6 months after the recall. Rates of utilization for CHF and MI remained relatively flat through the study period, Dr. Jackevicius said, but rates of ED visits for stroke/TIA showed “a very small relative increase: 6% and 8% in ED visits and hospitalizations, respectively.” Respective P values were .020 and .037.
As for the nature of the ED visits after the recall, Dr. Jackevicius said the study did not tease that out. Many visits could have been for uncontrolled HTN or to get expired prescriptions refilled.
“But either way, even if it is just getting a new prescription, this isn’t the best response,” she said. We need to have a better system where patients can more easily or with less burden deal with a recall.”
Session moderator Seth S. Martin, MD, MHS, of Johns Hopkins University in Baltimore, echoed Dr. Jackevicius’s concerns about the handling of drug recalls. “Recalls are increasing,” he said. “Is this just the tip of the iceberg on the quality of generics and we’re going to see these floodgates open? Is this going to be chaos or is this more isolated to this class of medication, the ARBs? This is becoming a little concerning.”
Dr. Jackevicius made note of the recalls that followed the original valsartan recall.
“This really opened a lot of questions in terms of the quality of generic products,” she said. Drug manufacturers are putting safeguards into place to detect these potential contaminants, she said, “but a lot more work needs to be done to ensure the supply. All of these recalls and the prominence of this will be increased.”
The response to the recalls also must undergo revision, she said, citing the experiences of the United States and Canada. “There isn’t really a good system or strategy for recalls in either country,” Dr. Jackevicius said, noting that regulatory bodies notify prescribers and physicians, but “they don’t know which patients are on it.”
A better strategy would be to involve pharmacies more in the process. “The pharmacies have the lot numbers, and they will know what patients are on the recalled drug,” she said. “The pharmacists are the ones who are making the changes in the drugs, and giving them the responsibility so patients don’t have to go into the ED is important. If it’s a basic interchange of a drug, the pharmacists can do that to help raise compliance.”
Dr. Jackevicius had no relevant relationships to disclose.
SOURCE: Jackevicius J. AHA 2019. Session FS.AOS.F1.
REPORTING FROM AHA 2019
Key clinical point: Neither Canada nor the United States has a good system or strategy for recalling generic drugs.
Major finding: One in 10 patients may have discontinued therapy after the recall.
Study details: Population study of prescribing patterns and health utilization rates of 55,461 patients on valsartan before and after the July 2018 recall.
Disclosures: Dr. Jackevicius has no relevant financial relationships to report.
Source: Jackevicius C. AHA 2019. Session FS.AOS.F1.
What repair is best for juxtarenal aneurysm?
CHICAGO – Outcomes with fenestrated endografts and endograft anchors to repair abdominal aortic aneurysms (AAAs) in the region of the renal artery have improved as the techniques have gained popularity in recent years, but open repair may still achieve better overall results, vascular surgeons on opposite sides of the controversy contended during a debate at the annual meeting of the Midwestern Vascular Surgery Society.
Fenestrated endovascular aortic repair (FEVAR) “is as safe as open surgery to treat complex aneurysm,” said Carlos Bechara, MD, of Loyola University Medical Center in Chicago. “EndoAnchors [Medtronic] do provide an excellent off-the-shelf solution to treat short, hostile necks with promising short-term results.”
Arguing for open repair was Paul DiMusto, MD, of the University of Wisconsin–Madison. “Open repair has an equal perioperative mortality to FEVAR,” Dr. DiMusto said, adding that the open approach also has a higher long-term branch patency rate, lower secondary-intervention rate, a lower incidence of long-term renal failure, and higher long-term survival. “So putting that all together, open repair is best,” he said.
They staked out their positions by citing a host of published trials.
“The presence of a short neck can create a challenging clinical scenario for an endovascular repair of abdominal aortic aneurysm,” Dr. Bechara said. However, he noted he was discussing complex aneurysm in which the aortic clamp is placed above the renal arteries, differentiating it from infrarenal AAA in which the clamp is below the renal arteries with no renal ischemia time. He noted a 2011 study that determined a short neck was a predictor of Type 1A endoleak after AAA repair, but that compliance with best practices at the time was poor; more than 44% of EVARs did not follow the manufacturer’s instruction (Circulation. 2011;123:2848-55).
But FEVAR was approved by the Food and Drug Administration in 2012, with an indication for an infrarenal neck length of 4-14 mm, Dr. Bechara noted. Since then, several studies have reported excellent outcomes with the technique. An early small study of 67 patients reported a 100% technical success rate with one patient having a Type 1 endoleak at 3 years (J Vasc Surg. 2014;60:1420-8).
This year, a larger study evaluated 6,825 patients in the American College of Surgeons National Surgical Quality Improvement Program who had FEVAR, open AAA repair or standard infrarenal endovascular repair during 2012-2016. “Actually, the fenestrated approach had fewer complications than open repair and the outcomes were comparable to standard EVAR,” Dr. Bechara noted. The trial reported FEVAR had lower rates of perioperative mortality (1.8% vs. 8.8%; P = .001), postoperative renal dysfunction (1.4% vs. 7.7%; P = .002), and overall complications (11% vs. 33%; P less than.001) than did open repair (J Vasc Surg. 2019;69:1670-78).
In regard to the use of endograft anchors for treatment of endoleaks, migrating grafts, and high-risk seal zones, Dr. Bechara noted they are a good “off-the-shelf” choice for complex AAA repair. He cited current results of a cohort of 70 patients with short-neck AAA (J Vasc Surg. 2019;70:732-40). “This study showed a procedural success rate at 97% and a technical success rate at 88.6%,” he said. “They had no stent migration, no increase in sac size or AAA rupture or open conversion.”
He also pointed to just-published results from a randomized trial of 881 patients with up to 14 years of follow-up that found comparable rates of death/secondary procedures, as well as durability, between patients who had endovascular and open repairs (77.7% and 75.5%, respectively, N Engl J Med. 2019;380:2126-35). Also, he noted that hospital volume is an important predictor of success with open repair, with high-volume centers reporting lower mortality (3.9%) than low-volume centers (9%; Ann Surg. 2018 Nov 29. doi: 10.1097/SLA.0000000000002873). “So not many centers are doing high-volume open aortic surgery,” he said.
To make his case that open surgery for juxtarenal AAAs is superior, Dr. DiMusto cited a number of recent studies, including a three-center trial of 200 patients who had open and FEVAR procedures (J Endovasc Ther. 2019;26:105-12). “There was no difference in perioperative mortality [2.2% for FEVAR, 1.9% in open repair], ” Dr. DiMusto said “There was a higher freedom from reintervention in the open group [96% vs. 78%], and there was higher long-term vessel patency in the open group” (97.5% having target patency for open vs. 93.3% for FEVAR).
He also pointed to a meta-analysis of 2,326 patients that found similar outcomes for mortality and postoperative renal insufficiency between FEVAR and open repair, around 4.1%, but showed significantly higher rates of renal failure in FEVAR, at 19.7% versus 7.7% (J Vasc Surg. 2015;61:242-55). This study also reported significantly more secondary interventions with FEVAR, 12.7% vs. 4.9%, Dr. DiMusto said.
Another study of 3,253 complex AAA repairs, including 887 FEVAR and 2,125 open procedures, showed that FEVAR had a technical success rate of 97%, with no appreciable difference in perioperative mortality between the two procedures (Ann Surg. 2019 Feb 1. doi: 10.1097/SLA.0000000000003094).
However, Dr. DiMusto said, adjusted 3-year mortality in this study was higher with FEVAR, and further analysis yielded outcomes that favored open repair. “After excluding perioperative deaths, differences remained, with 9% mortality for FEVAR and 5% for open repair [P = .02],” he said. “This corresponded to a 66% higher risk for overall mortality following FEVAR.”
What’s more, Dr. DiMusto said, draft guidelines from the National Institute for Health and Care Excellence in the United Kingdom advise against offering complex EVAR to people with an unruptured AAA under two scenarios: if open surgery is an option; and even if they’re unable to have surgery because of anesthetic or medical issues. The final guidelines have yet to be released.
Dr. Bechara disclosed financial relationships with Gore Medical and Cook Medical and equity interest in MOKITA Medical. Dr. DiMusto has no relevant financial disclosures.
CHICAGO – Outcomes with fenestrated endografts and endograft anchors to repair abdominal aortic aneurysms (AAAs) in the region of the renal artery have improved as the techniques have gained popularity in recent years, but open repair may still achieve better overall results, vascular surgeons on opposite sides of the controversy contended during a debate at the annual meeting of the Midwestern Vascular Surgery Society.
Fenestrated endovascular aortic repair (FEVAR) “is as safe as open surgery to treat complex aneurysm,” said Carlos Bechara, MD, of Loyola University Medical Center in Chicago. “EndoAnchors [Medtronic] do provide an excellent off-the-shelf solution to treat short, hostile necks with promising short-term results.”
Arguing for open repair was Paul DiMusto, MD, of the University of Wisconsin–Madison. “Open repair has an equal perioperative mortality to FEVAR,” Dr. DiMusto said, adding that the open approach also has a higher long-term branch patency rate, lower secondary-intervention rate, a lower incidence of long-term renal failure, and higher long-term survival. “So putting that all together, open repair is best,” he said.
They staked out their positions by citing a host of published trials.
“The presence of a short neck can create a challenging clinical scenario for an endovascular repair of abdominal aortic aneurysm,” Dr. Bechara said. However, he noted he was discussing complex aneurysm in which the aortic clamp is placed above the renal arteries, differentiating it from infrarenal AAA in which the clamp is below the renal arteries with no renal ischemia time. He noted a 2011 study that determined a short neck was a predictor of Type 1A endoleak after AAA repair, but that compliance with best practices at the time was poor; more than 44% of EVARs did not follow the manufacturer’s instruction (Circulation. 2011;123:2848-55).
But FEVAR was approved by the Food and Drug Administration in 2012, with an indication for an infrarenal neck length of 4-14 mm, Dr. Bechara noted. Since then, several studies have reported excellent outcomes with the technique. An early small study of 67 patients reported a 100% technical success rate with one patient having a Type 1 endoleak at 3 years (J Vasc Surg. 2014;60:1420-8).
This year, a larger study evaluated 6,825 patients in the American College of Surgeons National Surgical Quality Improvement Program who had FEVAR, open AAA repair or standard infrarenal endovascular repair during 2012-2016. “Actually, the fenestrated approach had fewer complications than open repair and the outcomes were comparable to standard EVAR,” Dr. Bechara noted. The trial reported FEVAR had lower rates of perioperative mortality (1.8% vs. 8.8%; P = .001), postoperative renal dysfunction (1.4% vs. 7.7%; P = .002), and overall complications (11% vs. 33%; P less than.001) than did open repair (J Vasc Surg. 2019;69:1670-78).
In regard to the use of endograft anchors for treatment of endoleaks, migrating grafts, and high-risk seal zones, Dr. Bechara noted they are a good “off-the-shelf” choice for complex AAA repair. He cited current results of a cohort of 70 patients with short-neck AAA (J Vasc Surg. 2019;70:732-40). “This study showed a procedural success rate at 97% and a technical success rate at 88.6%,” he said. “They had no stent migration, no increase in sac size or AAA rupture or open conversion.”
He also pointed to just-published results from a randomized trial of 881 patients with up to 14 years of follow-up that found comparable rates of death/secondary procedures, as well as durability, between patients who had endovascular and open repairs (77.7% and 75.5%, respectively, N Engl J Med. 2019;380:2126-35). Also, he noted that hospital volume is an important predictor of success with open repair, with high-volume centers reporting lower mortality (3.9%) than low-volume centers (9%; Ann Surg. 2018 Nov 29. doi: 10.1097/SLA.0000000000002873). “So not many centers are doing high-volume open aortic surgery,” he said.
To make his case that open surgery for juxtarenal AAAs is superior, Dr. DiMusto cited a number of recent studies, including a three-center trial of 200 patients who had open and FEVAR procedures (J Endovasc Ther. 2019;26:105-12). “There was no difference in perioperative mortality [2.2% for FEVAR, 1.9% in open repair], ” Dr. DiMusto said “There was a higher freedom from reintervention in the open group [96% vs. 78%], and there was higher long-term vessel patency in the open group” (97.5% having target patency for open vs. 93.3% for FEVAR).
He also pointed to a meta-analysis of 2,326 patients that found similar outcomes for mortality and postoperative renal insufficiency between FEVAR and open repair, around 4.1%, but showed significantly higher rates of renal failure in FEVAR, at 19.7% versus 7.7% (J Vasc Surg. 2015;61:242-55). This study also reported significantly more secondary interventions with FEVAR, 12.7% vs. 4.9%, Dr. DiMusto said.
Another study of 3,253 complex AAA repairs, including 887 FEVAR and 2,125 open procedures, showed that FEVAR had a technical success rate of 97%, with no appreciable difference in perioperative mortality between the two procedures (Ann Surg. 2019 Feb 1. doi: 10.1097/SLA.0000000000003094).
However, Dr. DiMusto said, adjusted 3-year mortality in this study was higher with FEVAR, and further analysis yielded outcomes that favored open repair. “After excluding perioperative deaths, differences remained, with 9% mortality for FEVAR and 5% for open repair [P = .02],” he said. “This corresponded to a 66% higher risk for overall mortality following FEVAR.”
What’s more, Dr. DiMusto said, draft guidelines from the National Institute for Health and Care Excellence in the United Kingdom advise against offering complex EVAR to people with an unruptured AAA under two scenarios: if open surgery is an option; and even if they’re unable to have surgery because of anesthetic or medical issues. The final guidelines have yet to be released.
Dr. Bechara disclosed financial relationships with Gore Medical and Cook Medical and equity interest in MOKITA Medical. Dr. DiMusto has no relevant financial disclosures.
CHICAGO – Outcomes with fenestrated endografts and endograft anchors to repair abdominal aortic aneurysms (AAAs) in the region of the renal artery have improved as the techniques have gained popularity in recent years, but open repair may still achieve better overall results, vascular surgeons on opposite sides of the controversy contended during a debate at the annual meeting of the Midwestern Vascular Surgery Society.
Fenestrated endovascular aortic repair (FEVAR) “is as safe as open surgery to treat complex aneurysm,” said Carlos Bechara, MD, of Loyola University Medical Center in Chicago. “EndoAnchors [Medtronic] do provide an excellent off-the-shelf solution to treat short, hostile necks with promising short-term results.”
Arguing for open repair was Paul DiMusto, MD, of the University of Wisconsin–Madison. “Open repair has an equal perioperative mortality to FEVAR,” Dr. DiMusto said, adding that the open approach also has a higher long-term branch patency rate, lower secondary-intervention rate, a lower incidence of long-term renal failure, and higher long-term survival. “So putting that all together, open repair is best,” he said.
They staked out their positions by citing a host of published trials.
“The presence of a short neck can create a challenging clinical scenario for an endovascular repair of abdominal aortic aneurysm,” Dr. Bechara said. However, he noted he was discussing complex aneurysm in which the aortic clamp is placed above the renal arteries, differentiating it from infrarenal AAA in which the clamp is below the renal arteries with no renal ischemia time. He noted a 2011 study that determined a short neck was a predictor of Type 1A endoleak after AAA repair, but that compliance with best practices at the time was poor; more than 44% of EVARs did not follow the manufacturer’s instruction (Circulation. 2011;123:2848-55).
But FEVAR was approved by the Food and Drug Administration in 2012, with an indication for an infrarenal neck length of 4-14 mm, Dr. Bechara noted. Since then, several studies have reported excellent outcomes with the technique. An early small study of 67 patients reported a 100% technical success rate with one patient having a Type 1 endoleak at 3 years (J Vasc Surg. 2014;60:1420-8).
This year, a larger study evaluated 6,825 patients in the American College of Surgeons National Surgical Quality Improvement Program who had FEVAR, open AAA repair or standard infrarenal endovascular repair during 2012-2016. “Actually, the fenestrated approach had fewer complications than open repair and the outcomes were comparable to standard EVAR,” Dr. Bechara noted. The trial reported FEVAR had lower rates of perioperative mortality (1.8% vs. 8.8%; P = .001), postoperative renal dysfunction (1.4% vs. 7.7%; P = .002), and overall complications (11% vs. 33%; P less than.001) than did open repair (J Vasc Surg. 2019;69:1670-78).
In regard to the use of endograft anchors for treatment of endoleaks, migrating grafts, and high-risk seal zones, Dr. Bechara noted they are a good “off-the-shelf” choice for complex AAA repair. He cited current results of a cohort of 70 patients with short-neck AAA (J Vasc Surg. 2019;70:732-40). “This study showed a procedural success rate at 97% and a technical success rate at 88.6%,” he said. “They had no stent migration, no increase in sac size or AAA rupture or open conversion.”
He also pointed to just-published results from a randomized trial of 881 patients with up to 14 years of follow-up that found comparable rates of death/secondary procedures, as well as durability, between patients who had endovascular and open repairs (77.7% and 75.5%, respectively, N Engl J Med. 2019;380:2126-35). Also, he noted that hospital volume is an important predictor of success with open repair, with high-volume centers reporting lower mortality (3.9%) than low-volume centers (9%; Ann Surg. 2018 Nov 29. doi: 10.1097/SLA.0000000000002873). “So not many centers are doing high-volume open aortic surgery,” he said.
To make his case that open surgery for juxtarenal AAAs is superior, Dr. DiMusto cited a number of recent studies, including a three-center trial of 200 patients who had open and FEVAR procedures (J Endovasc Ther. 2019;26:105-12). “There was no difference in perioperative mortality [2.2% for FEVAR, 1.9% in open repair], ” Dr. DiMusto said “There was a higher freedom from reintervention in the open group [96% vs. 78%], and there was higher long-term vessel patency in the open group” (97.5% having target patency for open vs. 93.3% for FEVAR).
He also pointed to a meta-analysis of 2,326 patients that found similar outcomes for mortality and postoperative renal insufficiency between FEVAR and open repair, around 4.1%, but showed significantly higher rates of renal failure in FEVAR, at 19.7% versus 7.7% (J Vasc Surg. 2015;61:242-55). This study also reported significantly more secondary interventions with FEVAR, 12.7% vs. 4.9%, Dr. DiMusto said.
Another study of 3,253 complex AAA repairs, including 887 FEVAR and 2,125 open procedures, showed that FEVAR had a technical success rate of 97%, with no appreciable difference in perioperative mortality between the two procedures (Ann Surg. 2019 Feb 1. doi: 10.1097/SLA.0000000000003094).
However, Dr. DiMusto said, adjusted 3-year mortality in this study was higher with FEVAR, and further analysis yielded outcomes that favored open repair. “After excluding perioperative deaths, differences remained, with 9% mortality for FEVAR and 5% for open repair [P = .02],” he said. “This corresponded to a 66% higher risk for overall mortality following FEVAR.”
What’s more, Dr. DiMusto said, draft guidelines from the National Institute for Health and Care Excellence in the United Kingdom advise against offering complex EVAR to people with an unruptured AAA under two scenarios: if open surgery is an option; and even if they’re unable to have surgery because of anesthetic or medical issues. The final guidelines have yet to be released.
Dr. Bechara disclosed financial relationships with Gore Medical and Cook Medical and equity interest in MOKITA Medical. Dr. DiMusto has no relevant financial disclosures.
EXPERT ANALYSIS FROM MIDWESTERN VASCULAR 2019
Chronic kidney disease may not be deterrent for B-FEVAR
CHICAGO – Although advanced renal dysfunction is a major contraindication for open repair of complex thoracoabdominal aneurysms (TAAA) and pararenal aneurysms (PRA), a single-center study of patients who had branched-fenestrated endovascular aneurysm repair (B-FEVAR) found that those with severe or moderate dysfunction and those with normal kidney function had similar results, according to a study reported at the annual meeting of the Midwestern Vascular Surgery Society.
“In our series of patients with stage 4 and 5 chronic kidney disease, branched-fenestration aneurysm repair for pararenal and thoracoabdominal aneurysm was associated with acceptable morbidity and mortality,” said Luis C. Cajas-Monson, MD, of the Mayo Clinic in Rochester, Minn. “Although often a contraindication for open repair, B-FEVAR could be a safe alternative for TAAA patients with poor renal function.”
The study evaluated 231 patients who had B-FEVAR for the following etiologies: 80 for PRA; 89 for Type I to III TAAA; and 62 for type IV TAAA. The patients had at least 1 year of follow-up. A small percentage of patients (4%; n = 9) had stage IV or V chronic kidney disease; the remainder had stage I to III CKD. The study compared results in the lower- and higher-stage CKD groups.
“The frequency of endovascular aortic aneurysm repair continues to increase, and it has advanced to treating more complex aortic pathology,” Dr. Cajas-Monson said. “There appears to be no significant decline in renal function with complex EVAR.” He noted that in open TAAA repair, the more severe the chronic kidney disease state, the worse the outcomes.
The Mayo researchers set out to evaluate the impact of renal function on survival after B-FEVAR for TAAA and PRA. “We hypothesized that renal function is not a significant factor in early and late survival after B-FEVAR,” Dr. Cajas-Monson said. TAAA patients represented 65% of the study population, with 59% having Extent I to III and 41% having Extent IV disease.
Dr. Cajas-Monson noted that demographics were comparable between the higher- and lower-stage CKD groups, with the exception of higher baseline creatinine levels in the CKD 4/5 patients: 3.14 vs. 1.13 (P less than .001). Operative outcomes and length of stay were also similar.
The higher-stage group had a higher overall rate of major adverse events, but given the small sample size this was not found to be significantly different (44% vs. 29%; P = .26). However, there were no events of perioperative death, stroke, paraplegia or estimated blood loss greater than 1 L in the higher-stage patients, while the lower-stage group had low percentages of these events.
Three-year survival was 84% in the lower-stage group and 75% in the higher-stage group.
Dr. Cajas-Monson acknowledged that the small sample size was a limitation of the study. “Further evaluation of patients with renal dysfunction is needed to validate our initial findings,” he said.
This abstract of this study was published in the Journal of Vascular Surgery (2019. 70 [3]:e67).
Dr. Cajas-Monson had no financial relationships to disclose.
SOURCE: Cajas-Monson LC et al. Midwestern Vascular 2019, Abstract 19.
CHICAGO – Although advanced renal dysfunction is a major contraindication for open repair of complex thoracoabdominal aneurysms (TAAA) and pararenal aneurysms (PRA), a single-center study of patients who had branched-fenestrated endovascular aneurysm repair (B-FEVAR) found that those with severe or moderate dysfunction and those with normal kidney function had similar results, according to a study reported at the annual meeting of the Midwestern Vascular Surgery Society.
“In our series of patients with stage 4 and 5 chronic kidney disease, branched-fenestration aneurysm repair for pararenal and thoracoabdominal aneurysm was associated with acceptable morbidity and mortality,” said Luis C. Cajas-Monson, MD, of the Mayo Clinic in Rochester, Minn. “Although often a contraindication for open repair, B-FEVAR could be a safe alternative for TAAA patients with poor renal function.”
The study evaluated 231 patients who had B-FEVAR for the following etiologies: 80 for PRA; 89 for Type I to III TAAA; and 62 for type IV TAAA. The patients had at least 1 year of follow-up. A small percentage of patients (4%; n = 9) had stage IV or V chronic kidney disease; the remainder had stage I to III CKD. The study compared results in the lower- and higher-stage CKD groups.
“The frequency of endovascular aortic aneurysm repair continues to increase, and it has advanced to treating more complex aortic pathology,” Dr. Cajas-Monson said. “There appears to be no significant decline in renal function with complex EVAR.” He noted that in open TAAA repair, the more severe the chronic kidney disease state, the worse the outcomes.
The Mayo researchers set out to evaluate the impact of renal function on survival after B-FEVAR for TAAA and PRA. “We hypothesized that renal function is not a significant factor in early and late survival after B-FEVAR,” Dr. Cajas-Monson said. TAAA patients represented 65% of the study population, with 59% having Extent I to III and 41% having Extent IV disease.
Dr. Cajas-Monson noted that demographics were comparable between the higher- and lower-stage CKD groups, with the exception of higher baseline creatinine levels in the CKD 4/5 patients: 3.14 vs. 1.13 (P less than .001). Operative outcomes and length of stay were also similar.
The higher-stage group had a higher overall rate of major adverse events, but given the small sample size this was not found to be significantly different (44% vs. 29%; P = .26). However, there were no events of perioperative death, stroke, paraplegia or estimated blood loss greater than 1 L in the higher-stage patients, while the lower-stage group had low percentages of these events.
Three-year survival was 84% in the lower-stage group and 75% in the higher-stage group.
Dr. Cajas-Monson acknowledged that the small sample size was a limitation of the study. “Further evaluation of patients with renal dysfunction is needed to validate our initial findings,” he said.
This abstract of this study was published in the Journal of Vascular Surgery (2019. 70 [3]:e67).
Dr. Cajas-Monson had no financial relationships to disclose.
SOURCE: Cajas-Monson LC et al. Midwestern Vascular 2019, Abstract 19.
CHICAGO – Although advanced renal dysfunction is a major contraindication for open repair of complex thoracoabdominal aneurysms (TAAA) and pararenal aneurysms (PRA), a single-center study of patients who had branched-fenestrated endovascular aneurysm repair (B-FEVAR) found that those with severe or moderate dysfunction and those with normal kidney function had similar results, according to a study reported at the annual meeting of the Midwestern Vascular Surgery Society.
“In our series of patients with stage 4 and 5 chronic kidney disease, branched-fenestration aneurysm repair for pararenal and thoracoabdominal aneurysm was associated with acceptable morbidity and mortality,” said Luis C. Cajas-Monson, MD, of the Mayo Clinic in Rochester, Minn. “Although often a contraindication for open repair, B-FEVAR could be a safe alternative for TAAA patients with poor renal function.”
The study evaluated 231 patients who had B-FEVAR for the following etiologies: 80 for PRA; 89 for Type I to III TAAA; and 62 for type IV TAAA. The patients had at least 1 year of follow-up. A small percentage of patients (4%; n = 9) had stage IV or V chronic kidney disease; the remainder had stage I to III CKD. The study compared results in the lower- and higher-stage CKD groups.
“The frequency of endovascular aortic aneurysm repair continues to increase, and it has advanced to treating more complex aortic pathology,” Dr. Cajas-Monson said. “There appears to be no significant decline in renal function with complex EVAR.” He noted that in open TAAA repair, the more severe the chronic kidney disease state, the worse the outcomes.
The Mayo researchers set out to evaluate the impact of renal function on survival after B-FEVAR for TAAA and PRA. “We hypothesized that renal function is not a significant factor in early and late survival after B-FEVAR,” Dr. Cajas-Monson said. TAAA patients represented 65% of the study population, with 59% having Extent I to III and 41% having Extent IV disease.
Dr. Cajas-Monson noted that demographics were comparable between the higher- and lower-stage CKD groups, with the exception of higher baseline creatinine levels in the CKD 4/5 patients: 3.14 vs. 1.13 (P less than .001). Operative outcomes and length of stay were also similar.
The higher-stage group had a higher overall rate of major adverse events, but given the small sample size this was not found to be significantly different (44% vs. 29%; P = .26). However, there were no events of perioperative death, stroke, paraplegia or estimated blood loss greater than 1 L in the higher-stage patients, while the lower-stage group had low percentages of these events.
Three-year survival was 84% in the lower-stage group and 75% in the higher-stage group.
Dr. Cajas-Monson acknowledged that the small sample size was a limitation of the study. “Further evaluation of patients with renal dysfunction is needed to validate our initial findings,” he said.
This abstract of this study was published in the Journal of Vascular Surgery (2019. 70 [3]:e67).
Dr. Cajas-Monson had no financial relationships to disclose.
SOURCE: Cajas-Monson LC et al. Midwestern Vascular 2019, Abstract 19.
REPORTING FROM MIDWESTERN VASCULAR 2019
Retinal artery blockage doesn’t necessarily portend stroke
CHICAGO – Occlusion of the retinal artery has been thought to be a predictor of stroke, but an analysis of patients with diagnosed retinal artery occlusion at Cleveland Clinic has found that their risk of stroke is about the same as the general population, a researcher reported at the annual meeting of the Midwestern Vascular Surgery Society.
“Subsequent hemispheric stroke is rare with or following retinal artery occlusion (RAO),” said David Laczynski, MD, a vascular surgeon at the Cleveland Clinic. “We do caution that large database studies may be overestimating the risk of stroke after RAO.” Studies have reported a stroke rate of up to 20% at 1 year, he said (Am J Ophthalmol. 2012;154:645-52).
ROA is a thromboembolic disorder of the vessels that provide blood to the back of the eye. American Academy of Ophthalmology preferred practice patterns recommend that patients with central RAO should be referred to the emergency department or a stroke center.
“As the vascular surgeon who’s on the receiving end of these consults, we have little data to provide to our patients as far as what their prognosis is,” Dr. Laczynski said. He noted the pathogenesis varies and that the diagnosis is difficult to arrive at. Fluorescein angiography imaging of the retina is essential to confirm diagnosis of ROA, but Dr. Laczynski said that many institutions do not have access to this level of imaging.
The study evaluated 221 patients whose RAO was confirmed with fluorescein angiography from 2004 to 2018 at the Cleveland Clinic Cole Eye Institute. The impetus of the study was to use the eye center to evaluate the institution’s experience with RAO, Dr. Laczynski said. “We were specifically concerned with looking at confirmed, symptomatic RAO with the risk of subsequent stroke,” he said. The study’s hypothesis was that RAO is not associated with an increased risk of stroke. The study population is the largest series in ROA ever reported, Dr. Laczynski said.
The average age of patients was 66 years. With a median follow-up of 2.2 years, the stroke rate was 2.3% (n = 5), with four of the strokes occurring at the time of RAO and one at 1.2 years later. Only one stroke patient had greater than 50% stenosis of the carotid artery. The rate of stroke, death, or MI was 10% (n = 22), Dr. Laczynski said. When concurrent ischemic events were excluded, the stroke rate was less than 1%.
“Sixty-three percent of patients (n = 141) had carotid imaging, but only 14.2% (n = 20) had more than 50% stenosis of the carotid artery,” Dr. Laczynski said. “Ten patients had carotid intervention.”
Among study limitations Dr. Laczynski pointed out were its single-center, retrospective nature and that not all patients had carotid artery imaging. “We cannot make any conclusion in regard to RAO and carotid artery disease,” Dr. Laczynski said.
This study was also published in the Journal of Vascular Surgery (2019 Sep;70[3]:e59-60).
Dr. Laczynski has no financial relationships to disclose.
SOURCE: Laczynski DJ et al. Midwestern Vascular 2019. J Vasc Surg. 2019 Sep;70[3]:e59-60.
CHICAGO – Occlusion of the retinal artery has been thought to be a predictor of stroke, but an analysis of patients with diagnosed retinal artery occlusion at Cleveland Clinic has found that their risk of stroke is about the same as the general population, a researcher reported at the annual meeting of the Midwestern Vascular Surgery Society.
“Subsequent hemispheric stroke is rare with or following retinal artery occlusion (RAO),” said David Laczynski, MD, a vascular surgeon at the Cleveland Clinic. “We do caution that large database studies may be overestimating the risk of stroke after RAO.” Studies have reported a stroke rate of up to 20% at 1 year, he said (Am J Ophthalmol. 2012;154:645-52).
ROA is a thromboembolic disorder of the vessels that provide blood to the back of the eye. American Academy of Ophthalmology preferred practice patterns recommend that patients with central RAO should be referred to the emergency department or a stroke center.
“As the vascular surgeon who’s on the receiving end of these consults, we have little data to provide to our patients as far as what their prognosis is,” Dr. Laczynski said. He noted the pathogenesis varies and that the diagnosis is difficult to arrive at. Fluorescein angiography imaging of the retina is essential to confirm diagnosis of ROA, but Dr. Laczynski said that many institutions do not have access to this level of imaging.
The study evaluated 221 patients whose RAO was confirmed with fluorescein angiography from 2004 to 2018 at the Cleveland Clinic Cole Eye Institute. The impetus of the study was to use the eye center to evaluate the institution’s experience with RAO, Dr. Laczynski said. “We were specifically concerned with looking at confirmed, symptomatic RAO with the risk of subsequent stroke,” he said. The study’s hypothesis was that RAO is not associated with an increased risk of stroke. The study population is the largest series in ROA ever reported, Dr. Laczynski said.
The average age of patients was 66 years. With a median follow-up of 2.2 years, the stroke rate was 2.3% (n = 5), with four of the strokes occurring at the time of RAO and one at 1.2 years later. Only one stroke patient had greater than 50% stenosis of the carotid artery. The rate of stroke, death, or MI was 10% (n = 22), Dr. Laczynski said. When concurrent ischemic events were excluded, the stroke rate was less than 1%.
“Sixty-three percent of patients (n = 141) had carotid imaging, but only 14.2% (n = 20) had more than 50% stenosis of the carotid artery,” Dr. Laczynski said. “Ten patients had carotid intervention.”
Among study limitations Dr. Laczynski pointed out were its single-center, retrospective nature and that not all patients had carotid artery imaging. “We cannot make any conclusion in regard to RAO and carotid artery disease,” Dr. Laczynski said.
This study was also published in the Journal of Vascular Surgery (2019 Sep;70[3]:e59-60).
Dr. Laczynski has no financial relationships to disclose.
SOURCE: Laczynski DJ et al. Midwestern Vascular 2019. J Vasc Surg. 2019 Sep;70[3]:e59-60.
CHICAGO – Occlusion of the retinal artery has been thought to be a predictor of stroke, but an analysis of patients with diagnosed retinal artery occlusion at Cleveland Clinic has found that their risk of stroke is about the same as the general population, a researcher reported at the annual meeting of the Midwestern Vascular Surgery Society.
“Subsequent hemispheric stroke is rare with or following retinal artery occlusion (RAO),” said David Laczynski, MD, a vascular surgeon at the Cleveland Clinic. “We do caution that large database studies may be overestimating the risk of stroke after RAO.” Studies have reported a stroke rate of up to 20% at 1 year, he said (Am J Ophthalmol. 2012;154:645-52).
ROA is a thromboembolic disorder of the vessels that provide blood to the back of the eye. American Academy of Ophthalmology preferred practice patterns recommend that patients with central RAO should be referred to the emergency department or a stroke center.
“As the vascular surgeon who’s on the receiving end of these consults, we have little data to provide to our patients as far as what their prognosis is,” Dr. Laczynski said. He noted the pathogenesis varies and that the diagnosis is difficult to arrive at. Fluorescein angiography imaging of the retina is essential to confirm diagnosis of ROA, but Dr. Laczynski said that many institutions do not have access to this level of imaging.
The study evaluated 221 patients whose RAO was confirmed with fluorescein angiography from 2004 to 2018 at the Cleveland Clinic Cole Eye Institute. The impetus of the study was to use the eye center to evaluate the institution’s experience with RAO, Dr. Laczynski said. “We were specifically concerned with looking at confirmed, symptomatic RAO with the risk of subsequent stroke,” he said. The study’s hypothesis was that RAO is not associated with an increased risk of stroke. The study population is the largest series in ROA ever reported, Dr. Laczynski said.
The average age of patients was 66 years. With a median follow-up of 2.2 years, the stroke rate was 2.3% (n = 5), with four of the strokes occurring at the time of RAO and one at 1.2 years later. Only one stroke patient had greater than 50% stenosis of the carotid artery. The rate of stroke, death, or MI was 10% (n = 22), Dr. Laczynski said. When concurrent ischemic events were excluded, the stroke rate was less than 1%.
“Sixty-three percent of patients (n = 141) had carotid imaging, but only 14.2% (n = 20) had more than 50% stenosis of the carotid artery,” Dr. Laczynski said. “Ten patients had carotid intervention.”
Among study limitations Dr. Laczynski pointed out were its single-center, retrospective nature and that not all patients had carotid artery imaging. “We cannot make any conclusion in regard to RAO and carotid artery disease,” Dr. Laczynski said.
This study was also published in the Journal of Vascular Surgery (2019 Sep;70[3]:e59-60).
Dr. Laczynski has no financial relationships to disclose.
SOURCE: Laczynski DJ et al. Midwestern Vascular 2019. J Vasc Surg. 2019 Sep;70[3]:e59-60.
REPORTING FROM MIDWESTERN VASCULAR 2019
Key clinical point: Retinal artery occlusion may not necessarily increase one’s stroke risk.
Major finding: The risk of stroke in patients with RAO was 2.3%.
Study details: A retrospective, single-institution review of 221 patients from 2004 to 2018.
Disclosures: Dr. Laczynski has no financial relationships to disclose.
Source: Laczynski DJ et al. Midwestern Vascular 2019. J Vasc Surg. 2019 Sep;70[3]:e59-60.
F-BEVAR safe in patients with one kidney
CHICAGO – Patients who have one kidney do as well after fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal or thoracoabdominal aortic aneurysm as patients with both kidneys, according to a study of almost 300 patients presented at the annual meeting of the Midwestern Vascular Surgery Society.
“Despite the worse baseline renal function associated with single functioning kidney patients, F-BEVAR is safe and effective with nearly identical outcomes in patients with a SFK [single functioning kidney] as compared to patients with two functioning kidneys,” said Keouna Pather of Mayo Clinic, Rochester, Minn.
The study evaluated 287 F-BEVAR patients enrolled in a physician-sponsored investigation device exemption study from November 2013 to October 2018. Thirty of those patients had one kidney, the remaining 257 were the control group. Ms. Pather noted that characteristics were similar between both patient groups with the exception that SFK patients were younger (age 70 vs. 74 years; P = .009) and had larger renal artery diameter (6 vs. 5.7 mm; P = .05). “Patients with a SFK had enlargement of their renal artery in a compensatory fashion,” she said.
Survival at 2 years was 92% for SFK patients and 84% for controls.
“The SFK patients did start at a worse baseline of CKD [chronic kidney disease] stages as compared to controls,” she noted. In the SFK group, 63% (n = 19) had Stage III CKD versus 40% (n = 104) of controls (P = .02). Likewise, rates of Stage IV CKD were 10% (n = 3) and 2% (n = 4), respectively (P = .03).
In terms of outcomes, two patients in the control group died within 30 days but none in the SFK group did, Ms. Pather said. Also, a higher percentage of SFK patients had estimated blood loss greater than 1 L, compared with controls (20% vs. 7%; P = .02). All other outcomes, including rates of acute kidney injury (20% vs. 12%; P = .26), were not statistically different, she said.
“Between the groups, there was no significant difference in CKD progression that needed stenting,” she added, with 27% (n = 8) and 26% (n = 67) of the SFK and controls progressing to CKD Stages III to V.
The study also identified predictors of acute kidney injury in SFK patients: total fluoroscopy time (hours), which raised the risk by 78.5%, and estimated blood loss greater than 1 L, which increased risk by 109%.
Predictors of renal function deterioration in SFK patients were renal artery occlusion or reintervention for branch stenosis or kink, which raised the risk threefold; a Crawford extent II, which more than doubled the risk; and acute kidney injury, which raised chances almost fivefold. “Development of postoperative AKI [acute kidney injury] is the most important predictor for renal function deterioration,” Pather said.
When freedom from renal function deterioration at 2 years was compared between the two groups, again the results were similar because of the small sample size of the SFK group: 100% for the SFK group and 84% for controls.
Ms. Pather had no financial relationships to disclose.
CHICAGO – Patients who have one kidney do as well after fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal or thoracoabdominal aortic aneurysm as patients with both kidneys, according to a study of almost 300 patients presented at the annual meeting of the Midwestern Vascular Surgery Society.
“Despite the worse baseline renal function associated with single functioning kidney patients, F-BEVAR is safe and effective with nearly identical outcomes in patients with a SFK [single functioning kidney] as compared to patients with two functioning kidneys,” said Keouna Pather of Mayo Clinic, Rochester, Minn.
The study evaluated 287 F-BEVAR patients enrolled in a physician-sponsored investigation device exemption study from November 2013 to October 2018. Thirty of those patients had one kidney, the remaining 257 were the control group. Ms. Pather noted that characteristics were similar between both patient groups with the exception that SFK patients were younger (age 70 vs. 74 years; P = .009) and had larger renal artery diameter (6 vs. 5.7 mm; P = .05). “Patients with a SFK had enlargement of their renal artery in a compensatory fashion,” she said.
Survival at 2 years was 92% for SFK patients and 84% for controls.
“The SFK patients did start at a worse baseline of CKD [chronic kidney disease] stages as compared to controls,” she noted. In the SFK group, 63% (n = 19) had Stage III CKD versus 40% (n = 104) of controls (P = .02). Likewise, rates of Stage IV CKD were 10% (n = 3) and 2% (n = 4), respectively (P = .03).
In terms of outcomes, two patients in the control group died within 30 days but none in the SFK group did, Ms. Pather said. Also, a higher percentage of SFK patients had estimated blood loss greater than 1 L, compared with controls (20% vs. 7%; P = .02). All other outcomes, including rates of acute kidney injury (20% vs. 12%; P = .26), were not statistically different, she said.
“Between the groups, there was no significant difference in CKD progression that needed stenting,” she added, with 27% (n = 8) and 26% (n = 67) of the SFK and controls progressing to CKD Stages III to V.
The study also identified predictors of acute kidney injury in SFK patients: total fluoroscopy time (hours), which raised the risk by 78.5%, and estimated blood loss greater than 1 L, which increased risk by 109%.
Predictors of renal function deterioration in SFK patients were renal artery occlusion or reintervention for branch stenosis or kink, which raised the risk threefold; a Crawford extent II, which more than doubled the risk; and acute kidney injury, which raised chances almost fivefold. “Development of postoperative AKI [acute kidney injury] is the most important predictor for renal function deterioration,” Pather said.
When freedom from renal function deterioration at 2 years was compared between the two groups, again the results were similar because of the small sample size of the SFK group: 100% for the SFK group and 84% for controls.
Ms. Pather had no financial relationships to disclose.
CHICAGO – Patients who have one kidney do as well after fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal or thoracoabdominal aortic aneurysm as patients with both kidneys, according to a study of almost 300 patients presented at the annual meeting of the Midwestern Vascular Surgery Society.
“Despite the worse baseline renal function associated with single functioning kidney patients, F-BEVAR is safe and effective with nearly identical outcomes in patients with a SFK [single functioning kidney] as compared to patients with two functioning kidneys,” said Keouna Pather of Mayo Clinic, Rochester, Minn.
The study evaluated 287 F-BEVAR patients enrolled in a physician-sponsored investigation device exemption study from November 2013 to October 2018. Thirty of those patients had one kidney, the remaining 257 were the control group. Ms. Pather noted that characteristics were similar between both patient groups with the exception that SFK patients were younger (age 70 vs. 74 years; P = .009) and had larger renal artery diameter (6 vs. 5.7 mm; P = .05). “Patients with a SFK had enlargement of their renal artery in a compensatory fashion,” she said.
Survival at 2 years was 92% for SFK patients and 84% for controls.
“The SFK patients did start at a worse baseline of CKD [chronic kidney disease] stages as compared to controls,” she noted. In the SFK group, 63% (n = 19) had Stage III CKD versus 40% (n = 104) of controls (P = .02). Likewise, rates of Stage IV CKD were 10% (n = 3) and 2% (n = 4), respectively (P = .03).
In terms of outcomes, two patients in the control group died within 30 days but none in the SFK group did, Ms. Pather said. Also, a higher percentage of SFK patients had estimated blood loss greater than 1 L, compared with controls (20% vs. 7%; P = .02). All other outcomes, including rates of acute kidney injury (20% vs. 12%; P = .26), were not statistically different, she said.
“Between the groups, there was no significant difference in CKD progression that needed stenting,” she added, with 27% (n = 8) and 26% (n = 67) of the SFK and controls progressing to CKD Stages III to V.
The study also identified predictors of acute kidney injury in SFK patients: total fluoroscopy time (hours), which raised the risk by 78.5%, and estimated blood loss greater than 1 L, which increased risk by 109%.
Predictors of renal function deterioration in SFK patients were renal artery occlusion or reintervention for branch stenosis or kink, which raised the risk threefold; a Crawford extent II, which more than doubled the risk; and acute kidney injury, which raised chances almost fivefold. “Development of postoperative AKI [acute kidney injury] is the most important predictor for renal function deterioration,” Pather said.
When freedom from renal function deterioration at 2 years was compared between the two groups, again the results were similar because of the small sample size of the SFK group: 100% for the SFK group and 84% for controls.
Ms. Pather had no financial relationships to disclose.
REPORTING FROM MIDWESTERN VASCULAR 2019
Key clinical point: Fenestrated-branched endovascular repair of abdominal aortic aneurysm is safe and effective.
Major finding: Two-year survival rates were 92% for one-kidney patients and 84% for those with two kidneys.
Study details: Retrospective review of a prospectively collected database of 287 patients who had F-BEVAR from 2013 to 2018.
Disclosures: Ms. Pather has no financial relationships to disclose.
Source: Pather K et al. Midwestern Vascular 2019, Abstract 2.
Isolated iliac disease a marker for better health status?
CHICAGO – Surgery and endovascular treatment for peripheral artery disease (PAD) among patients with claudication improves health status more in the setting of isolated iliac disease and multilevel disease than in other forms of PAD, which suggests that vascular specialists should give pause before pursuing interventions on superficial femoral and infrapopliteal artery lesions, a researcher of the PORTRAIT registry reported at the annual meeting of the Midwestern Vascular Surgery Society.
“Our analysis demonstrated that interventions for aortoiliac disease and multilevel disease appeared to improve overall health status more over time compared to femoral-popliteal disease and infrapopliteal disease,” said Todd R. Vogel, MD, of the University of Missouri Health System in Columbia.
The study evaluated improvement in Peripheral Artery Questionnaire (PAQ) scores from baseline to post intervention in 623 patients in the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry. The patients were selected and combined with anatomic data on the nature of their claudication. Aortoiliac-only (AI) disease represented 20.4% (n = 127) of the study group, femoral-popliteal-only (FP) 35.5% (n = 221), infrapopliteal/distal (IP) 6.3% (n = 39), and multilevel disease (ML) 37.9% (n = 236).
In terms of demographics, patients in the AI group tended to be younger (average age of 61.2 years vs. 66.6 years for the study overall; P less than .001) and had a higher rate of smokers (96.1% former and current smokers vs. 90.7% overall; P less than .001). Otherwise, Dr. Vogel noted, demographics, smoking status, and severity of claudication were similar across the disease groups.
Rates of medical intervention were similar in the AI and ML disease groups, which were primarily endovascular procedures: 26% and 27%, respectively. The AI group had the highest rates of endovascular interventions, at 24%, with the FP group at 15%, IP at 11% and ML at 21%. Those who did not have surgery or endovascular aneurysm repair were treated medically.
“The AI group did significantly better at 3 months than the other groups,” Dr. Vogel pointed out, noting that at 12 months those patients had an average PAQ score of around 78 versus scores of around 75 for FP, 74 for IP, and 70 for ML.
“In the AI group, there’s also an immediate increase in quality of life that is sustained over time,” he said. At 3 months, PAQ scores in AI patients who had endovascular aneurysm repair increased 41 points over baseline, leveling off to a 38.8-point gain at 12 months, the highest gains across all disease groups and all treatment categories.
“However,” Dr. Vogel added, “the group with ML disease probably was the most improved over time on the PAQ scores,” he said, explaining that across the board, this group had lower baseline PAQ scores than all the other groups.
“No significant benefits were found with intervention versus medical management for FP and IP,” he said. “This suggests that intervention should be considered after medical management has been exhausted.”
Dr. Vogel also said the findings support aggressive treatment of AI and ML for symptomatic claudication. “This anatomic region represents the greatest potential benefit for improving overall health status in patients with symptomatic PAD,” he said.
Dr. Vogel had no relevant financial relationships to disclose.
CHICAGO – Surgery and endovascular treatment for peripheral artery disease (PAD) among patients with claudication improves health status more in the setting of isolated iliac disease and multilevel disease than in other forms of PAD, which suggests that vascular specialists should give pause before pursuing interventions on superficial femoral and infrapopliteal artery lesions, a researcher of the PORTRAIT registry reported at the annual meeting of the Midwestern Vascular Surgery Society.
“Our analysis demonstrated that interventions for aortoiliac disease and multilevel disease appeared to improve overall health status more over time compared to femoral-popliteal disease and infrapopliteal disease,” said Todd R. Vogel, MD, of the University of Missouri Health System in Columbia.
The study evaluated improvement in Peripheral Artery Questionnaire (PAQ) scores from baseline to post intervention in 623 patients in the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry. The patients were selected and combined with anatomic data on the nature of their claudication. Aortoiliac-only (AI) disease represented 20.4% (n = 127) of the study group, femoral-popliteal-only (FP) 35.5% (n = 221), infrapopliteal/distal (IP) 6.3% (n = 39), and multilevel disease (ML) 37.9% (n = 236).
In terms of demographics, patients in the AI group tended to be younger (average age of 61.2 years vs. 66.6 years for the study overall; P less than .001) and had a higher rate of smokers (96.1% former and current smokers vs. 90.7% overall; P less than .001). Otherwise, Dr. Vogel noted, demographics, smoking status, and severity of claudication were similar across the disease groups.
Rates of medical intervention were similar in the AI and ML disease groups, which were primarily endovascular procedures: 26% and 27%, respectively. The AI group had the highest rates of endovascular interventions, at 24%, with the FP group at 15%, IP at 11% and ML at 21%. Those who did not have surgery or endovascular aneurysm repair were treated medically.
“The AI group did significantly better at 3 months than the other groups,” Dr. Vogel pointed out, noting that at 12 months those patients had an average PAQ score of around 78 versus scores of around 75 for FP, 74 for IP, and 70 for ML.
“In the AI group, there’s also an immediate increase in quality of life that is sustained over time,” he said. At 3 months, PAQ scores in AI patients who had endovascular aneurysm repair increased 41 points over baseline, leveling off to a 38.8-point gain at 12 months, the highest gains across all disease groups and all treatment categories.
“However,” Dr. Vogel added, “the group with ML disease probably was the most improved over time on the PAQ scores,” he said, explaining that across the board, this group had lower baseline PAQ scores than all the other groups.
“No significant benefits were found with intervention versus medical management for FP and IP,” he said. “This suggests that intervention should be considered after medical management has been exhausted.”
Dr. Vogel also said the findings support aggressive treatment of AI and ML for symptomatic claudication. “This anatomic region represents the greatest potential benefit for improving overall health status in patients with symptomatic PAD,” he said.
Dr. Vogel had no relevant financial relationships to disclose.
CHICAGO – Surgery and endovascular treatment for peripheral artery disease (PAD) among patients with claudication improves health status more in the setting of isolated iliac disease and multilevel disease than in other forms of PAD, which suggests that vascular specialists should give pause before pursuing interventions on superficial femoral and infrapopliteal artery lesions, a researcher of the PORTRAIT registry reported at the annual meeting of the Midwestern Vascular Surgery Society.
“Our analysis demonstrated that interventions for aortoiliac disease and multilevel disease appeared to improve overall health status more over time compared to femoral-popliteal disease and infrapopliteal disease,” said Todd R. Vogel, MD, of the University of Missouri Health System in Columbia.
The study evaluated improvement in Peripheral Artery Questionnaire (PAQ) scores from baseline to post intervention in 623 patients in the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry. The patients were selected and combined with anatomic data on the nature of their claudication. Aortoiliac-only (AI) disease represented 20.4% (n = 127) of the study group, femoral-popliteal-only (FP) 35.5% (n = 221), infrapopliteal/distal (IP) 6.3% (n = 39), and multilevel disease (ML) 37.9% (n = 236).
In terms of demographics, patients in the AI group tended to be younger (average age of 61.2 years vs. 66.6 years for the study overall; P less than .001) and had a higher rate of smokers (96.1% former and current smokers vs. 90.7% overall; P less than .001). Otherwise, Dr. Vogel noted, demographics, smoking status, and severity of claudication were similar across the disease groups.
Rates of medical intervention were similar in the AI and ML disease groups, which were primarily endovascular procedures: 26% and 27%, respectively. The AI group had the highest rates of endovascular interventions, at 24%, with the FP group at 15%, IP at 11% and ML at 21%. Those who did not have surgery or endovascular aneurysm repair were treated medically.
“The AI group did significantly better at 3 months than the other groups,” Dr. Vogel pointed out, noting that at 12 months those patients had an average PAQ score of around 78 versus scores of around 75 for FP, 74 for IP, and 70 for ML.
“In the AI group, there’s also an immediate increase in quality of life that is sustained over time,” he said. At 3 months, PAQ scores in AI patients who had endovascular aneurysm repair increased 41 points over baseline, leveling off to a 38.8-point gain at 12 months, the highest gains across all disease groups and all treatment categories.
“However,” Dr. Vogel added, “the group with ML disease probably was the most improved over time on the PAQ scores,” he said, explaining that across the board, this group had lower baseline PAQ scores than all the other groups.
“No significant benefits were found with intervention versus medical management for FP and IP,” he said. “This suggests that intervention should be considered after medical management has been exhausted.”
Dr. Vogel also said the findings support aggressive treatment of AI and ML for symptomatic claudication. “This anatomic region represents the greatest potential benefit for improving overall health status in patients with symptomatic PAD,” he said.
Dr. Vogel had no relevant financial relationships to disclose.
REPORTING FROM MIDWESTERN VASCULAR 2019
Study questions preemptive TEVAR for extended type A dissections
CHICAGO – The need for additional intervention after repair of the ascending aorta in extended type A aortic dissection has been thought to follow the practice for type B dissection and favor preemptive thoracic endovascular aortic repair. However, preemptive TEVAR may, at least in the midterm, provide no benefit in patients with extended type A dissections, according to results reported at the annual meeting of the Midwestern Vascular Surgery Society.
“TEVAR does not appear to be indicated in patients with extended type A dissections after acute aortic repair,” said Amy B. Reed, MD, of the University of Minnesota.
The study’s hypothesis was that growth rates of dissection and the need for additional intervention in the descending thoracic aorta are similar between extended type A (ExTA) and type B aortic dissection after initial repair of the ascending aorta. Dr. Reed noted that investigators from the INSTEAD-XL trial reported that preemptive TEVAR improved outcomes in patients with type B dissections (Circ Cardiovasc Interv. 2013;6:407-16). “The thinking has been that patients with uncomplicated ExTA would also benefit from early TEVAR,” Dr. Reed said.
The study evaluated 87 consecutive patients from 2011 to 2018, 43 with ExTA and 44 with type B dissections. Characteristics of both groups were similar, except the type B group had a significantly higher rate of coronary artery disease, 16% vs. 0% (P = .01). The distal extent of the dissection was beyond the aortic bifurcation in 75% of the ExTA patients and 52% of the type B group, “so we felt that these groups were really well matched,” Dr. Reed said.
Of the 43 ExTA patients, five had repair and 38 had no intervention. At an average follow-up of 33 months, 23 of the no-intervention patients showed no growth of their dissection, Dr. Reed said. In the type B group, 15 had no repair, and of those nine showed no growth (one patient died early and five did show growth).
“When we look at intervention-free survival, there’s a significant difference between our ExTA patients vs. our type B patients over time, with significantly more type B patients requiring intervention,” she said. At 28 months, 88% of ExTA were intervention free, whereas at 9 months 35% of type B patients were.
“We feel that, following the repair of ascending acute aortic dissection, in those patients with ExTA dissections, there does appear to be a slow progression of distal aortic disease,” Dr. Reed said. “Rarely do these patients develop complications such as dissection needing intervention either in the acute hospital period or delayed.”
Because the findings are based on medium-term follow-up, she said, “We certainly need further follow-up to confirm these midterm findings.”
Dr. Reed had no relevant financial relationships to disclose.
CHICAGO – The need for additional intervention after repair of the ascending aorta in extended type A aortic dissection has been thought to follow the practice for type B dissection and favor preemptive thoracic endovascular aortic repair. However, preemptive TEVAR may, at least in the midterm, provide no benefit in patients with extended type A dissections, according to results reported at the annual meeting of the Midwestern Vascular Surgery Society.
“TEVAR does not appear to be indicated in patients with extended type A dissections after acute aortic repair,” said Amy B. Reed, MD, of the University of Minnesota.
The study’s hypothesis was that growth rates of dissection and the need for additional intervention in the descending thoracic aorta are similar between extended type A (ExTA) and type B aortic dissection after initial repair of the ascending aorta. Dr. Reed noted that investigators from the INSTEAD-XL trial reported that preemptive TEVAR improved outcomes in patients with type B dissections (Circ Cardiovasc Interv. 2013;6:407-16). “The thinking has been that patients with uncomplicated ExTA would also benefit from early TEVAR,” Dr. Reed said.
The study evaluated 87 consecutive patients from 2011 to 2018, 43 with ExTA and 44 with type B dissections. Characteristics of both groups were similar, except the type B group had a significantly higher rate of coronary artery disease, 16% vs. 0% (P = .01). The distal extent of the dissection was beyond the aortic bifurcation in 75% of the ExTA patients and 52% of the type B group, “so we felt that these groups were really well matched,” Dr. Reed said.
Of the 43 ExTA patients, five had repair and 38 had no intervention. At an average follow-up of 33 months, 23 of the no-intervention patients showed no growth of their dissection, Dr. Reed said. In the type B group, 15 had no repair, and of those nine showed no growth (one patient died early and five did show growth).
“When we look at intervention-free survival, there’s a significant difference between our ExTA patients vs. our type B patients over time, with significantly more type B patients requiring intervention,” she said. At 28 months, 88% of ExTA were intervention free, whereas at 9 months 35% of type B patients were.
“We feel that, following the repair of ascending acute aortic dissection, in those patients with ExTA dissections, there does appear to be a slow progression of distal aortic disease,” Dr. Reed said. “Rarely do these patients develop complications such as dissection needing intervention either in the acute hospital period or delayed.”
Because the findings are based on medium-term follow-up, she said, “We certainly need further follow-up to confirm these midterm findings.”
Dr. Reed had no relevant financial relationships to disclose.
CHICAGO – The need for additional intervention after repair of the ascending aorta in extended type A aortic dissection has been thought to follow the practice for type B dissection and favor preemptive thoracic endovascular aortic repair. However, preemptive TEVAR may, at least in the midterm, provide no benefit in patients with extended type A dissections, according to results reported at the annual meeting of the Midwestern Vascular Surgery Society.
“TEVAR does not appear to be indicated in patients with extended type A dissections after acute aortic repair,” said Amy B. Reed, MD, of the University of Minnesota.
The study’s hypothesis was that growth rates of dissection and the need for additional intervention in the descending thoracic aorta are similar between extended type A (ExTA) and type B aortic dissection after initial repair of the ascending aorta. Dr. Reed noted that investigators from the INSTEAD-XL trial reported that preemptive TEVAR improved outcomes in patients with type B dissections (Circ Cardiovasc Interv. 2013;6:407-16). “The thinking has been that patients with uncomplicated ExTA would also benefit from early TEVAR,” Dr. Reed said.
The study evaluated 87 consecutive patients from 2011 to 2018, 43 with ExTA and 44 with type B dissections. Characteristics of both groups were similar, except the type B group had a significantly higher rate of coronary artery disease, 16% vs. 0% (P = .01). The distal extent of the dissection was beyond the aortic bifurcation in 75% of the ExTA patients and 52% of the type B group, “so we felt that these groups were really well matched,” Dr. Reed said.
Of the 43 ExTA patients, five had repair and 38 had no intervention. At an average follow-up of 33 months, 23 of the no-intervention patients showed no growth of their dissection, Dr. Reed said. In the type B group, 15 had no repair, and of those nine showed no growth (one patient died early and five did show growth).
“When we look at intervention-free survival, there’s a significant difference between our ExTA patients vs. our type B patients over time, with significantly more type B patients requiring intervention,” she said. At 28 months, 88% of ExTA were intervention free, whereas at 9 months 35% of type B patients were.
“We feel that, following the repair of ascending acute aortic dissection, in those patients with ExTA dissections, there does appear to be a slow progression of distal aortic disease,” Dr. Reed said. “Rarely do these patients develop complications such as dissection needing intervention either in the acute hospital period or delayed.”
Because the findings are based on medium-term follow-up, she said, “We certainly need further follow-up to confirm these midterm findings.”
Dr. Reed had no relevant financial relationships to disclose.
REPORTING FROM MIDWESTERN VASCULAR 2019