Objective Under Food and Drug Administration investigational device exemption, the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) has been testing the safety of less aggressive ...anticoagulation than recommended by the American College of Cardiology/American Heart Association guidelines after implantation of an approved bileaflet mechanical valve. Methods In this first limb of the PROACT, patients with elevated risk factors for thromboembolism were randomized at 33 US centers to receive lower dose warfarin (test international normalized ratio INR, 1.5-2.0) or continue standard warfarin (control INR, 2.0-3.0), 3 months after mechanical aortic valve replacement. The INR was adjusted by home monitoring; all patients received 81 mg aspirin daily. Adverse events were independently adjudicated. Results A total of 375 aortic valve replacement patients were randomized into control (n = 190) and test (n = 185) groups from September 2006 to December 2009. The mean age ± standard deviation was 55.2 ± 12.5 years; 79% were men; and 93% were in sinus rhythm preoperatively. Calcific degeneration was present in 67%; active endocarditis was excluded. Concomitant procedures included coronary artery bypass grafting (27%), aortic aneurysm repair (14%), and other (25%). The follow-up duration averaged 3.82 years (755.7 patient-years pt-yrs for control; 675.2 pt-yrs for test). The mean INR was 2.50 ± 0.63 for the control and 1.89 ± 0.49 for the test groups ( P < .0001). The test group experienced significantly lower major (1.48% vs 3.26%/pt-yr; P = .047) and minor (1.32% vs 3.41%/pt-yr; P = .021) bleeding rates. The incidence of stroke, transient ischemic attack, total neurologic events, and all-cause mortality were similar between the 2 groups. Conclusions INR can be safely maintained between 1.5 and 2.0 after aortic valve replacement with this approved bileaflet mechanical prosthesis. With low-dose aspirin, this resulted in a significantly lower risk of bleeding, without a significant increase in thromboembolism.
Percutaneous mitral repair with the MitraClip device (Evalve, Menlo Park, CA) has been reported. Preserving conventional surgical options in the event of percutaneous treatment failure is important. ...We describe surgical treatment at varying intervals after the MitraClip procedure in 32 patients.
One hundred seven patients with moderate-to-severe or severe mitral regurgitation who were either symptomatic (91%) or, if asymptomatic (9%), had evidence of left ventricular dysfunction were enrolled as part of the Endovascular Valve Edge-to-Edge REpair STudy (EVEREST) phase I registry study or as "roll-in" subjects in the EVEREST II study. Thirty-two of the 107 patients (30%) underwent surgery after an attempted MitraClip procedure.
Of the 32 patients undergoing post-clip mitral valve surgery, 23 patients (72%) had one or more clips implanted and 9 patients (28%) received no clip implant. The indications for mitral valve surgery in the 23 patients with a clip included partial clip detachment (n = 10), residual or recurrent mitral regurgitation greater than 2+ (n = 9), and other (atrial septal defect n = 2, device malfunction n = 1, and incorrectly diagnosed mitral stenosis n = 1). Twenty-seven of 31 patients (87%) underwent the surgical procedure planned before surgery (planned procedure unknown in 1 patient). Four of 25 patients (16%) with planned repair underwent mitral valve replacement.
Standard surgical options were preserved in patients who had surgery after percutaneous repair with the MitraClip device. Successful repair was feasible in the majority of patients after the MitraClip procedure, with repair performed as late as 18 months after clip implantation.
Tucked away: an infected thrombus Hubbard, Elizabeth, BA; Wise, Eric, MD, PhD; Hubbard, Bradley, MD ...
The American journal of medicine,
06/2016, Letnik:
129, Številka:
6
Journal Article
Recenzirano
Odprti dostop
A relic from a previously undiagnosed event was a persistent source of infection in a 50-year-old man. The patient presented to his primary care provider's office with a three-week history of fevers, ...dyspnea on exertion, nonproductive cough, and left shoulder pain. He was sent to the Emergency Department to exclude an acute pulmonary embolism after initial blood work revealed an elevated D-dimer level. Ciprofloxacin had been prescribed for a urinary tract infection 14 days earlier, after he was evaluated in the emergency department of another hospital. At that time, urine cultures grew methicillin-sensitive Staphylococcus aureus. Here, Hubbard et al discuss the assessment and management of infected thrombus.
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