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Icahn School of Medicine at Mount Sinai1, Harvard University2, Houston Methodist Hospital3, Riverside Methodist Hospital4, The Texas Heart Institute5, University of Michigan6, University of Pittsburgh7, United States Department of Veterans Affairs8, Spectrum Health9, University of Kansas10, Saint Francis University11, Duke University12, Johns Hopkins University13, PinnacleHealth System14, Medtronic plc15, Mayo Clinic16
TL;DR: In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aorti-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aorticsvalve replacement.
Abstract: BACKGROUND We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery. METHODS We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing. RESULTS A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, −0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke. CONCLUSIONS In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement. (Funded by Medtronic; U.S. CoreValve High Risk Study ClinicalTrials.gov number, NCT01240902.)
2,432 citations
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Harvard University1, University of Michigan2, PinnacleHealth System3, St. Luke's Hospital4, Spectrum Health5, Mount Sinai Hospital6, Scripps Research Institute7, University of Kansas8, Yale University9, Johns Hopkins University10, Alfred Hospital11, McGill University12, Saint Francis University13, University of Pittsburgh14, Mayo Clinic15, Medtronic plc16, Paradigm17
TL;DR: In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self‐expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months.
Abstract: Background Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is know...
2,240 citations
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Houston Methodist Hospital1, Erasmus University Rotterdam2, Beth Israel Deaconess Medical Center3, University of Copenhagen4, Pinnacle Financial Partners5, Mount Sinai Hospital6, New York University7, University of Michigan8, University of Pittsburgh9, Spectrum Health10, Mayo Clinic11, McGill University12, University of Bern13, Riverside Methodist Hospital14, Cedars-Sinai Medical Center15, Johns Hopkins University16, Medtronic plc17, Paradigm18
TL;DR: TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure.
Abstract: BackgroundAlthough transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. MethodsWe evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement. ResultsA total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 7...
2,095 citations
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TL;DR: Electrocardiographic monitoring with an ICM was superior to conventional follow-up for detecting atrial fibrillation after cryptogenic stroke in patients with cryptogenic Stroke.
Abstract: Background Current guidelines recommend at least 24 hours of electrocardiographic (ECG) monitoring after an ischemic stroke to rule out atrial fibrillation. However, the most effective duration and type of monitoring have not been established, and the cause of ischemic stroke remains uncertain despite a complete diagnostic evaluation in 20 to 40% of cases (cryptogenic stroke). Detection of atrial fibrillation after cryptogenic stroke has therapeutic implications. Methods We conducted a randomized, controlled study of 441 patients to assess whether long-term monitoring with an insertable cardiac monitor (ICM) is more effective than conventional follow-up (control) for detecting atrial fibrillation in patients with cryptogenic stroke. Patients 40 years of age or older with no evidence of atrial fibrillation during at least 24 hours of ECG monitoring underwent randomization within 90 days after the index event. The primary end point was the time to first detection of atrial fibrillation (lasting >30 seconds) within 6 months. Among the secondary end points was the time to first detection of atrial fibrillation within 12 months. Data were analyzed according to the intention-to-treat principle. Results By 6 months, atrial fibrillation had been detected in 8.9% of patients in the ICM group (19 patients) versus 1.4% of patients in the control group (3 patients) (hazard ratio, 6.4; 95% confidence interval [CI], 1.9 to 21.7; P<0.001). By 12 months, atrial fib rillation had been detected in 12.4% of patients in the ICM group (29 patients) versus 2.0% of patients in the control group (4 patients) (hazard ratio, 7.3; 95% CI, 2.6 to 20.8; P<0.001). Conclusions ECG monitoring with an ICM was superior to conventional follow-up for detecting atrial fibrillation after cryptogenic stroke. (Funded by Medtronic; CRYSTAL AF ClinicalTrials.gov number, NCT00924638.)
1,632 citations
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Stanford University1, Indiana University – Purdue University Indianapolis2, Emory University3, University of Oklahoma4, University of Kansas5, Cornell University6, Thomas Jefferson University7, Marshfield Clinic8, Veterans Health Administration9, University of California, Los Angeles10, St. Joseph's Hospital and Medical Center11, Rush University Medical Center12, University of Pennsylvania13, University of California, San Francisco14, University of Virginia15, Columbia University16, Harvard University17, Medtronic plc18
TL;DR: A multicenter, double‐blind, randomized trial of bilateral stimulation of the anterior nuclei of the thalamus for localization‐related epilepsy is reported.
Abstract: Summary
Purpose: We report a multicenter, double-blind, randomized trial of bilateral stimulation of the anterior nuclei of the thalamus for localization-related epilepsy
Methods: Participants were adults with medically refractory partial seizures, including secondarily generalized seizures Half received stimulation and half no stimulation during a 3-month blinded phase; then all received unblinded stimulation
Results: One hundred ten participants were randomized Baseline monthly median seizure frequency was 195 In the last month of the blinded phase the stimulated group had a 29% greater reduction in seizures compared with the control group, as estimated by a generalized estimating equations (GEE) model (p = 0002) Unadjusted median declines at the end of the blinded phase were 145% in the control group and 404% in the stimulated group Complex partial and “most severe” seizures were significantly reduced by stimulation By 2 years, there was a 56% median percent reduction in seizure frequency; 54% of patients had a seizure reduction of at least 50%, and 14 patients were seizure-free for at least 6 months Five deaths occurred and none were from implantation or stimulation No participant had symptomatic hemorrhage or brain infection Two participants had acute, transient stimulation-associated seizures Cognition and mood showed no group differences, but participants in the stimulated group were more likely to report depression or memory problems as adverse events
Discussion: Bilateral stimulation of the anterior nuclei of the thalamus reduces seizures Benefit persisted for 2 years of study Complication rates were modest Deep brain stimulation of the anterior thalamus is useful for some people with medically refractory partial and secondarily generalized seizures
1,444 citations
Authors
Showing all 5804 results
Name | H-index | Papers | Citations |
---|---|---|---|
David A. Kass | 127 | 580 | 58747 |
Tony L. Yaksh | 123 | 806 | 60898 |
Jeffrey J. Popma | 121 | 702 | 72455 |
Muthiah Manoharan | 96 | 497 | 44464 |
Richard E. Kuntz | 85 | 272 | 33372 |
Christopher K. Zarins | 83 | 435 | 33182 |
Laura Mauri | 83 | 375 | 44873 |
John W. Eaton | 82 | 298 | 26403 |
Kathleen A. Sluka | 81 | 282 | 19154 |
Bruce L. Wilkoff | 80 | 440 | 38518 |
Paul A. Gurbel | 77 | 589 | 28852 |
Giuseppe Boriani | 77 | 747 | 26166 |
Mark G. Stewart | 73 | 548 | 20995 |
Paul Van de Heyning | 72 | 424 | 19373 |
Douglas L. Jones | 70 | 512 | 21596 |