Biotronik today released results from the Castle-AF study exploring the use of catheter ablation to treat heart failure patients with atrial fibrillation, touting a 38% composite reduction in all-cause mortality and hospitalization for worsening heart failure.
The 398-patient, 33-site study compared the results of catheter ablation treatment for AF in heart failure patients using implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators to standard-of-care pharmacological therapy, the company said. Biotronik touted it as the largest study of its kind to date.
Results indicated a 47% reduction in mortality for patients treated with catheter ablation, as well as a 44% reduction in hospitalizations for worsening heart failure, the company said.
“Castle-AF is currently the only existing study that measures a hard primary outcome in patients who have received catheter ablation or conventional therapy for AF The results of this trial underscore the importance of catheter ablation as a mode of treatment, indicating that the procedure should be performed as early as possible and as a first-line therapy in this group of patients,” study co-lead Dr. Nassir Marrouche of the University of Utah said in a prepared statement.
“There has been a general lack of consensus within the scientific community on the most appropriate way to manage AF in heart failure patients. The indicative results from Castle-AF could pave the way for wider adoption of catheter ablation and may prompt changes in current guidelines for treatment. This could have a considerable impact on heart failure patients with coexisting AF,” study co-lead Dr. Johannes Brachmann said in a press release.
Study: Implanted cardiac monitors improve atrial fibrillation detection
Implantable cardiac monitors have detected a nearly 30% incidence rate of previously undiagnosed atrial fibrillation at 18 months in patients at high risk of both AF and stroke, according to a new study published in JAMA Cardiology.
In the trial, researchers implanted 385 individuals at high risk of both AF and stroke with insertable cardiac monitors, with approximately 90% having nonspecific symptoms for AF. Patients were monitored for 18 to 30 months.
At 18 months, trial investigators found that the detection rate of AF lasting 6 or more minutes was 29%, up from earlier detection rates of 6% at 30 days, 20% at 6 months and 27% at 12 months. At 24 and 30 months, detection rates were 34% and 40%, respectively, with a median time from device insertion to the 1st AF episode detection being 123 days.
For patients with AF lasting 6 or more minutes at 18 months, 10% had 1 or more episodes that lasted 24 hours or longer, with oral anticoagulation therapy prescribed for 56% of those patients.
Study authors wrote that the incidence of AF was still rising at 30 months and that ideal monitoring duration was unclear, noting limitations to the trial due to its modest size.
“Further trials regarding the value of detecting subclinical AF and of prophylactic therapies are warranted,” study authors wrote according to a press release.
Study: Renal denervation shown to lower blood pressure for hypertensive patients
A new study, published recently in Lancet, reports that renal denervation has been shown to lower blood pressure in hypertensive patients not currently taking medication.
In the Spyral HTN-Off Med study, trial investigators examined the use of Medtronic‘s (NYSE:MDT) Symplicity Spyral renal denervation system for patients with uncontrolled hypertension, or who were drug naive or stopped taking antihypertensive medications at least 4 weeks prior to the trial.
Results at 3-months from the 1st 80 patients in the trial showed a decline in office-based systolic and diastolic blood pressure of 10 mmHg and 5.3 mmHg respectively for those treated with renal denervation, compared to 2.3 mmHg and 0.3 mmHg in the sham treatment arm.
For 24-hour ambulatory blood pressure, data indicated a drop of 5.5 mmHg and 4.8 mmHg in systolic and diastolic blood pressure for patients treated with renal denervation, versus declines of 0.5 mmHg and 0.4 mmHg for those in the sham control.
No major safety events were reported in either arm, according to study researchers.
“The sham-controlled Symplicity HTN-3 trial failed to show a significant blood pressure lowering effect of renal denervation. We applied lessons from this trial to the Spyral HTN-Off Med study regarding how the procedure was performed, the patient population, and the influence of medications,” co-principal investigator Michael Boehm of Germany’s University of Saarland said in a press release.”All blood pressure measurements within the renal denervation arm showed statistically significant reductions from baseline, while none of the measurements in the sham arm were significantly reduced from baseline. This is particularly important as even small reductions correlate to significant reductions in death, stroke, and overall cardiovascular risk. The effectiveness of renal denervation in this study may have been due to the new procedural approach, which aimed to achieve complete denervation, and the fact that patients were not taking antihypertensive medications which may have confounded the results of previous studies.”
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