Day: 05/25/2013

Propofol Procedural Sedation Is Safe.

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No adverse outcomes occurred among 1000 adult propofol procedural sedation episodes.

To determine the safety of propofol for emergency department (ED) procedural sedation, researchers retrospectively applied a sedation adverse-event reporting tool to 1008 consecutive patients (age range, 15 to 97 years) who underwent procedural sedation at a single ED in the U.K. over a 5-year period. Sentinel events included oxygen saturation <75% for any length of time or <90% for more than 60 seconds, apnea lasting longer than 60 seconds, aspiration event, need for intubation, cardiovascular collapse, permanent neurologic disability, and death. Most patients were sedated for orthopedic procedures (77%) and cardioversion (9%). Monitoring included pulse oximetry, non-invasive blood pressure measurement, respiratory rate, and electrocardiography; nasal capnography was adopted near the end of the study period.

A total of 73 adverse events were reported: 11 sentinel, 34 moderate, 25 minor, and 3 minimal risk. Sentinel events included six episodes of prolonged hypotension (>60 seconds) requiring brief vasopressor support, and five episodes of hypoxia, all but one of which resolved with assisted ventilation. One patient with unstable ventricular tachycardia underwent cardioversion, vomited, and became hypoxic, necessitating intubation for airway protection and altered mentation. He was found to have a saddle pulmonary embolism and distal aortic thrombus; he survived to hospital discharge. No adverse outcomes related to procedural sedation were identified.

Comment: Several patients with sentinel adverse events had significant underlying medical comorbidities. Fortunately, no patients suffered any adverse outcomes related to the procedural sedation, but this study reminds us that proper monitoring, including capnography, and careful patient selection are crucial to ensure the safety of this procedure. Patients at high risk for adverse events, such as those with significant cardiopulmonary comorbidity, and those with difficult airways should be evaluated for possible sedation in the operating room.

 

Source: Journal Watch Emergency Medicine

 

Sofosbuvir Works for Patients Who Cannot Take Peginterferon.

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Two phase III studies confirm the efficacy of a sofosbuvir and ribavirin therapy in patients with HCV genotype 2 or 3 infection for whom peginterferon is not an option.

In patients infected with hepatitis C virus (HCV) genotype 2 or 3, treatment with peginterferon plus ribavirin has a sustained virologic response (SVR) of 70% to 85%. However, adverse effects of peginterferon are a barrier to treatment for many patients. Now, two industry-funded, phase III trials have evaluated the efficacy of sofosbuvir (400 mg daily) plus ribavirin (1000 mg–1200 mg daily) in these patients.

In a blinded, placebo-controlled trial, investigators randomized 280 patients for whom peginterferon therapy was not an option (e.g., adverse effects, contraindications for interferons, and patient refusal) to receive sofosbuvir/ribavirin or matching placebo for 12 weeks. In a blinded, active-control trial, researchers randomized 202 patients with prior nonresponse to peginterferon therapy to receive 12 or 16 weeks of sofosbuvir/ribavirin. The primary endpoint in both studies was SVR at 12 weeks after therapy ended.

In patients for whom peginterferon therapy was not an option, SVR was 78% for treatment with sofosbuvir/ribavirin compared with 0% for placebo (P<0.001). In previously treated patients, SVR was 50% for 12 weeks of therapy versus 73% for 16 weeks (P<0.001). SVR rates were lower for patients with genotype 3 versus genotype 2 in both treatment-naive patients (61% vs. 93%) and treatment-experienced patients who received therapy for 12 weeks (30% vs. 86%) or 16 weeks (62% vs. 94%).

SVR rates were lower in patients with cirrhosis than without, both in treatment-naive patients (overall, 61% vs. 81%; genotype 3 vs. 2, 21% vs. 94%) and treatment-experienced patients (overall, 66% vs. 76%; genotype 3 vs. 2 in 16-week group, 61% vs. 78%). In both studies, investigators found no evidence of resistance development, and discontinuation rates were low (1%–2%).

Comment: Oral sofosbuvir plus ribavirin is effective in patients with HCV genotypes 2 or 3 for whom peginterferon-based therapy is not an option or was previously ineffective. Of note, these sustained virologic response rates for sofosbuvir plus ribavirin are comparable to or higher than those previously reported for therapy with peginterferon plus ribavirin in this population.

Source: Journal Watch Gastroenterology

 

Burning Bridges: Must Warfarin Be Stopped for Device Implantation?

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In a randomized trial, heparin bridging for implantation of a pacemaker or implantable cardioverter-defibrillator was associated with an increase in device-pocket hematoma.

Warfarin increases the risk for bleeding. Surgery is associated with bleeding. The intuitive inference that patients should discontinue chronic warfarin therapy before undergoing surgery, combined with concern about the ensuing thromboembolic risk, has led to the standard use of intravenous heparin or subcutaneous low-molecular-weight heparin as an anticoagulation “bridge” during warfarin washout. However, some practitioners question the benefits of this practice.

In a multicenter trial, 681 warfarin recipients undergoing permanent pacemaker or implantable cardioverter-defibrillator implantation were randomized to continue warfarin or to discontinue warfarin with a heparin bridge for 5 days before surgery. All patients had an estimated annual risk for thromboembolism of 

≥5% (mean CHADS2 score, 3.4). The trial was stopped early because of a strongly significant increase in the rate of device-pocket hematoma in the heparin-bridging group compared with the warfarin-continuation group (16.0% vs. 3.5%). Two patients in the warfarin-continuation group experienced stroke or transient ischemic attack (compared with none in the heparin-bridging group); however, both had subtherapeutic international normalized ratios at the time of surgery.

Comment: These data confirm what many surgeons and electrophysiologists observe on a daily basis — heparin bridging during warfarin interruption increases bleeding risk even more than continuing warfarin does. The findings are important for patients with atrial fibrillation and a high annual risk for thromboembolism. Whether warfarin can be withheldwithout bridging in individuals at low risk for thromboembolism remains unstudied. For such patients, an effective strategy might be to stop warfarin 1 or 2 days — rather than the traditional 5 days — before surgery.

 

Source:Journal Watch Cardiology