The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve ...replacement (SAVR) among high operative mortality–risk patients.
The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability.
Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned.
A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years.
This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)
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Angiopoietin-like 3 (ANGPTL3) inhibits endothelial lipase and lipoprotein lipase. Injection of antisense oligonucleotides targeting
ANGPTL3
messenger RNA effects a reduction of atherogenic ...lipoproteins in humans and mice and a slowing of progression of atherosclerosis in mice.
Epidemiology and risk factors for delirium across hospital settings Vasilevskis, Eduard E., MD; Han, Jin H., MD, MSc; Hughes, Christopher G., MD ...
Baillière's best practice and research in clinical anaesthesiology/Bailliere's best practice & research. Clinical anaesthesiology,
09/2012, Letnik:
26, Številka:
3
Journal Article
Recenzirano
Odprti dostop
Delirium is one of the most common causes of acute end-organ dysfunction across hospital settings, occurring in as high as 80% of critically ill patients that require intensive care unit (ICU) care. ...The implications of this acute form of brain injury are profound. Across many hospital settings (emergency department, general medical ward, postoperative and ICU), a patient who experiences delirium is more likely to experience increased short- and long-term mortality, decreases in long-term cognitive function, increases in hospital length of stay and increased complications of hospital care. With the development of reliable setting-specific delirium-screening instruments, researchers have been able to highlight the predisposing and potentially modifiable risk factors that place patients at highest risk. Among the large number of risk factors discovered, administration of potent sedative medications, most notably benzodiazepines, is most consistently and strongly associated with an increased burden of delirium. Alternatively, in both the hospital and ICU, delirium can be prevented with the application of protocols that include early mobility/exercise. Future studies must work to understand the epidemiology across settings and focus upon modifiable risk factors that can be integrated into existing delirium prevention and treatment protocols.
Subclavian artery revascularization is frequently performed in the setting of thoracic endovascular aortic repair (TEVAR). However, there is little information on the short- and long-term outcomes of ...patients undergoing carotid to subclavian artery bypass in this clinical setting. As such, this study sought to define the early and late outcomes associated with this procedure.
Patients undergoing carotid-subclavian bypass in conjunction with TEVAR between June 2005 and September 2016 were retrospectively identified from a prospectively maintained, single-center aortic surgery database. The 30-day outcomes specific to the carotid-subclavian bypass procedure were analyzed, including cervical plexus nerve injury, bleeding complications, and local vascular complications. All preoperative and postoperative chest radiographs were carefully analyzed to assess for hemidiaphragm elevation indicative of phrenic nerve palsy. Long-term outcomes included primary graft patency and anastomotic complications.
Of 579 consecutive patients undergoing TEVAR during this time interval, 112 patients (19%) underwent concomitant carotid-subclavian bypass. The cohort was 38% female (n = 43), with a mean age of 65 ± 14 years. The majority of conduits were 8-mm polytetrafluoroethylene grafts (n = 107 95.5%), with a minority being reversed saphenous vein (n = 4 3.6%) or Dacron (n = 1 0.9%) grafts. The bypass procedure was done concurrently at the time of TEVAR in 91% (n = 102) of cases. The short-term complication rate attributed specifically to the carotid-subclavian bypass was 29% (n = 33). These complications included phrenic nerve palsy in 25% (n = 27), recurrent laryngeal nerve palsy in 5% (n = 6), axillary nerve palsy in 2% (n = 2), and neck hematoma requiring re-exploration in 1% (n = 1) of patients. The 30-day in-hospital all-cause mortality rate was 5% (n = 6), and the rate of permanent paraparesis or paraplegia was 0.9% (n = 1). Of the operative survivors (n = 106), follow-up imaging of the bypass graft was available in 87% (n = 92) of patients. Actuarial primary graft patency was 97% at 5 years. There were three patients (3%) with bypass graft occlusions, two of which were clinically silent and detected on follow-up imaging. The third was detected because of symptoms of subclavian steal and required repeated revascularization. Two patients (2%) developed a late anastomotic pseudoaneurysm requiring either endovascular (n = 1) or surgical (n = 1) intervention.
Carotid-subclavian bypass for revascularization of the subclavian artery performed in the setting of TEVAR is durable, although the true complication rate is likely higher than is generally reported in the literature because of a not insignificant rate of phrenic nerve palsy. These data should serve well as “gold standard” comparison data for emerging branch graft devices.
This phase 3 trial tested inotersen, a modified oligonucleotide that targets
TTR
messenger RNA, in the treatment of hereditary transthyretin amyloidosis, a disease in which misfolded transthyretin ...proteins are deposited in peripheral nerves and other tissues.
This Society for Vascular Surgery/Society of Thoracic Surgeons (SVS/STS) document illustrates and defines the overall nomenclature associated with type B aortic dissection. The contents describe a ...new classification system for practical use and reporting that includes the aortic arch. Chronicity of aortic dissection is also defined along with nomenclature in patients with prior aortic repair and other aortic pathologic processes, such as intramural hematoma and penetrating atherosclerotic ulcer. Complicated vs uncomplicated dissections are clearly defined with a new high-risk grouping that will undoubtedly grow in reporting and controversy. Follow-up criteria are also discussed with nomenclature for false lumen status in addition to measurement criteria and definitions of aortic remodeling. Overall, the document provides a facile framework of language that will allow more granular discussions and reporting of aortic dissection in the future.
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Purpose
Cognitive impairment after critical illness is common and debilitating. We developed a cognitive therapy program for critically ill patients and assessed the feasibility and safety of ...administering combined cognitive and physical therapy early during a critical illness.
Methods
We randomized 87 medical and surgical ICU patients with respiratory failure and/or shock in a 1:1:2 manner to three groups: usual care, early once-daily physical therapy, or early once-daily physical therapy plus a novel, progressive, twice-daily cognitive therapy protocol. Cognitive therapy included orientation, memory, attention, and problem-solving exercises, and other activities. We assessed feasibility outcomes of the early cognitive plus physical therapy intervention. At 3 months, we also assessed cognitive, functional, and health-related quality of life outcomes. Data are presented as median (interquartile range) or frequency (%).
Results
Early cognitive therapy was a delivered to 41/43 (95 %) of cognitive plus physical therapy patients on 100 % (92–100 %) of study days beginning 1.0 (1.0–1.0) day following enrollment. Physical therapy was received by 17/22 (77 %) of usual care patients, by 21/22 (95 %) of physical therapy only patients, and 42/43 (98 %) of cognitive plus physical therapy patients on 17 % (10–26 %), 67 % (46–87 %), and 75 % (59–88 %) of study days, respectively. Cognitive, functional, and health-related quality of life outcomes did not differ between groups at 3-month follow-up.
Conclusions
This pilot study demonstrates that early rehabilitation can be extended beyond physical therapy to include cognitive therapy. Future work to determine optimal patient selection, intensity of treatment, and benefits of cognitive therapy in the critically ill is needed.
The addition of ribociclib to hormone therapy showed a greater benefit with regard to overall survival than hormone therapy alone in women with hormone-receptor–positive, human epidermal growth ...factor receptor 2–negative advanced breast cancer.