Medicolegal Issues

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Does a short duration of perioperative smoking cessation lead to a reduction in postoperative complications?

Background: Prior studies have demonstrated a reduction in postoperative complications when patients stop smoking in the perioperative period. However, they have not clearly shown what effect a fairly short duration of cessation, such as a period of only four weeks, has on the frequency of complications.

Study design: Randomized controlled trial.

Setting: Four university-affiliated hospitals in Sweden.

Synopsis: Using 117 patients who were daily smokers for less than one year between the ages of 18-79 who were scheduled for elective general or orthopedic surgery, this study showed that a smoking-cessation intervention initiated as little as four weeks prior to surgery resulted in fewer postoperative complications. The complication rate was reduced from 41% in the control group to 21% in the intervention group, which received cessation counseling and nicotine-replacement therapy. The relative risk reduction was 49% (95% confidence interval, 3-40) with a number needed to treat of five.

Because this was a randomized controlled trial with a large observed benefit, it appears to be reasonable to endorse perioperative smoking cessation as late as four weeks before an elective surgery. The study was limited in its ability to detect a difference in wound infections by the small sample size and the possibility patients might have unblinded themselves to outcome assessors, causing an overestimation of the effect of the intervention on the primary outcome of all complications.

Bottom line: Perioperative smoking cessation reduces postoperative complications even when started just four weeks prior to surgery.

Citation: Lindstrom D, Azodi OS, Wladis A, et al. Effects of a perioperative smoking cessation intervention on postoperative complications. Ann Surg. 2008;248(5):739-745.

Does implantable-defibrillator therapy cause deterioration in quality of life for patients with heart failure?

Background: Patients with depressed left-ventricular function are known to have improved survival after receiving implantable cardioverter defibrillators (ICDs). However, there is concern ICD therapy can prolong survival at the expense of a diminished quality of life.

Study design: Randomized placebo-controlled trial.

Setting: Multiple centers in the U.S., Canada, and New Zealand.

Synopsis: Using 2,479 patients from the Sudden Cardiac Death in Heart Failure trial who were 18 and older and had stable heart failure and depressed left-ventricular function, this study demonstrated no significant quality-of-life difference at 30 months when compared with patients who received ICD, amiodarone, and state-of-the-art medical therapy or an amiodarone placebo and state-of-the-art medical therapy. While functional status did not differ at any time between the three groups, psychological well-being was improved in the ICD group at three months (p=0.01) and 12 months (p=0.03) when compared with the placebo group, but at 30 months there was no difference between the groups.

While the trial was randomized and placebo-controlled, the investigators were unable to blind patients or outcome assessors. Nevertheless, the lack of deterioration of quality of life in ICD patients is reassuring.

Bottom line: Placement of ICDs in heart failure patients with a high risk of sudden cardiac death does not appear to decrease quality of life.

Citation: Mark DB, Anstrom KJ, Sun JL, et al. Quality of life with defibrillator therapy or amiodarone in heart failure. N Engl J Med. 2008;359:999-1008.

CLINICAL SHORTS

SERIAL 2-POINT ULTRASONOGRAPHY PLUS D-DIMER IS EQUIVALENT TO WHOLE-LEG ULTRASONOGRAPHY FOR DIAGNOSING DVT

Randomized trials show that when comparing serial 2-point ultrasonography plus D-dimer testing with whole-leg ultrasonography, the strategies were equivalent in excluding a first episode of suspected DVT in outpatients.

Citation: Bernardi E, Camporese G, Buller HR, et al. Serial 2-point ultrasonography plus D-dimer vs whole-leg color-coded Doppler ultrasonography for diagnosing suspected symptomatic deep vein thrombosis. JAMA. 2008;300(14):1653-1659.

DAILY HEMODIALYSIS IS COST-EFFECTIVE IN ICU PATIENTS WITH ACUTE KIDNEY INJURY (AKI)

Markov model based on prospective trial data shows daily hemodialysis is cost-effective for AKI in the ICU compared with alternate-day hemodialysis.

Citation: Desai AA, Baras J, Berk BB, et al. Management of acute kidney injury in the intensive care unit. Arch Intern Med. 2008;168(16):1761-1767.

THROMBOLYSIS FOR IN-HOSPITAL STROKE IS SAFE, BUT ASSOCIATED WITH DELAYS

Prospective observational trial shows thrombolysis is safe and effective for in-hospital stroke, but statistically significant delays exist compared with out-of-hospital strokes.

Citation: Masjuan J, Simal P, Fuentes B, et al. In-hospital stroke treated with intravenous tissue plasminogen activator. Stroke. 2008;39:2614-2616.

ALGORITHM CAN IDENTIFY HIGH-RISK HEART FAILURE PATIENTS

Prospective observational study identifies clinical variables for a bedside algorithm, which stratifies the risk of hospitalized heart failure patients for early mortality or readmission to identify those who might benefit from closer follow-up.

Citation: O’Connor CM, Abraham WT, Albert NM, et al. Predictors of mortality after discharge in patients hospitalized with heart failure: an analysis from the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF). Am Heart J. 2008;156(4):662-673.

IN-HOSPITAL SMOKING-CESSATION INTERVENTIONS WITH FOLLOW-UP CAN WORK

Meta-analysis of 33 trials shows in-hospital smoking-cessation counseling followed up with more than one month of outpatient support can be effective.

Citation: Rigotti NA, Munafo MR, Stead LF. Smoking cessation interventions for hospitalized smokers. Arch Intern Med. 2008;168(18):1950-1960.

OMISSION OF KEY INFORMATION DURING SIGN-OUT LEADS TO ADVERSE CONSEQUENCES

An audio-taped study of sign-out among internal medicine house staff teams revealed omission of key information during sign-out resulted in delays in diagnosis or treatment.

Citation: Horwitz LI, Moin T, Krumholz HM, Wang L, Bradley EH. Consequences of inadequate sign-out for patient care. Arch Intern Med. 2008;168(16):1755-1760.

HOSPITAL PALLIATIVE CARE CONSULTATION TEAMS ARE ASSOCIATED WITH HOSPITAL COST SAVINGS

Analysis of administrative data from eight diverse hospitals with palliative-care programs revealed consultation with palliative care saved $1,696 (p<0.001) per hospital admission in patients discharged alive, and $4,098 (p=0.003) per hospital admission in patients who died in the hospital.

Citation: Morrison RS, Penrod JD, Cassel JB, et al. Cost savings associated with U.S. hospital palliative care consultation programs. Arch Intern Med. 2008;168(16):1783-1790.

HIGHER EDUCATIONAL DEBT INFLUENCES INTERNAL MEDICINE RESIDENT CAREER PLANS

U.S. medical graduates with a debt of $50,000 to $99,999 are more likely than those with no debt to choose a hospitalist career, and this preference increased with increased debt level.

Citation: McDonald FS, West CP, Popkave C, Kolars JC. Educational debt and reported career plans among internal medicine residents. Ann Intern Med. 2008;149:416-420.

BRAIN IMAGING IMPORTANT IN IDENTIFYING VASCULAR TERRITORY AFTER TIA OR MINOR STROKE

Neurologists were only moderately reliable at identifying the vascular territory of a TIA or motor stroke, highlighting the fact brain imaging is needed to accurately identify the vascular territories of these events.

Citation: Flossmann E, Redgrave JN, Briley D, Rothwell PM. Reliability of clinical diagnosis of the symptomatic vascular territory in patients with recent transient ischemic attack or minor stroke. Stroke. 2008;39:2457-2460.

HIGH-DOSE VITAMIN B SUPPLEMENTATION DOES NOT SLOW COGNITIVE DECLINE IN ALZHEIMER’S DISEASE

Multicenter, randomized, placebo-controlled trial finds no difference in the rate of cognitive decline in patients with Alzheimer’s disease treated with high-dose vitamin B supplements for 18 months.

Citation: Aisen PS, Schneider LS, Sano M, et al. High-dose B vitamin supplementation and cognitive decline in Alzheimer’s disease. JAMA. 2008; 300(15):1774-1783.

Can a simplified, revised Geneva score retain diagnostic accuracy and clinical utility?

Background: The revised Geneva score is a validated and objective clinical decision rule, but has multiple variables with different weights. This can make the tool cumbersome and difficult to remember, and could lead to inaccurate calculations and misjudgments in patient care.

Study design: Retrospective cohort study.

Setting: Four university-affiliated European hospitals.

Synopsis: Using data from two prior prospective trials involving patients with suspected pulmonary embolism (PE), this study showed re-analysis of these patients with a simplified, revised Geneva score, which gives only one point to each clinical factor, resulted in the same level of diagnostic accuracy. Specifically, data from 1,049 patients was used to construct a receiver-operating characteristic curve analysis comparing the standardized and simplified Geneva score, which showed areas under the curve of 0.75 (95% confidence interval 0.71-0.78) and 0.74 (0.70-0.77), respectively. Additionally, the safety of using this clinical tool to rule out PE was demonstrated when using both a three-level (low-intermediate probability) and a dichotomized scheme (PE unlikely) in combination with a negative D-dimer test.

The retrospective nature of the study was its major limitation. The authors suggest a prospective study to complete validation of the simplified, revised Geneva score.

Bottom line: With prospective analysis, it might be possible to further validate a simplified, revised Geneva score.

Citation: Klok FA, Mos ICM, Nijkeuter M, et al. Simplification of the revised Geneva score for assessing clinical probability of pulmonary embolism. Arch Intern Med. 2008;168(19):2131-2136.

Is the rate of postoperative major adverse cardiac events (MACEs) inversely related to time after percutaneous coronary intervention (PCI) with a drug-eluting stent (DES)?

Background: The American College of Cardiology and the American Heart Association recently released an advisory that included a recommendation to delay elective noncardiac surgery (NCS) for one year after DES placement. However, no large study addresses the timing of NCS after PCI with DES.

Study design: Retrospective observational study.

Setting: Mayo Clinic, Rochester, Minn.

Synopsis: Looking at 520 patients who had NCS after DES at the Mayo Clinic, 5.4% experienced MACEs, but the rate of MACEs was not significantly associated with the time after stent placement to surgery (p=0.337). However, observed rates of MACEs were lower after one year. Elderly patients and those going for emergent surgery are at the highest risk for MACE. Bleeding complications were not associated with antiplatelet use.

Although this study does not provide a clear cutoff time for when it is safe to proceed to NCS after DES, it is somewhat reassuring to see the relatively small number of MACEs and the lack of bleeding complications associated with antiplatelet use. However, careful coordination between hospitalists, cardiologists, anesthesiologists, and surgeons is still needed when coordinating NCS after DES, especially in the elderly or during emergent situations.

Bottom line: While time to noncardiac surgery after drug-eluting stent placement is not associated with major adverse cardiac events, observed rates of events are lower after one year.

Citation: Rabbitts JA, Nuttall GA, Brown MJ, et al. Cardiac risk of non-cardiac surgery after percutaneous coronary intervention with drug-eluting stents. Anesthesiology.2008;109: 596-604.

Is the risk of MACEs and bleeding events for patients undergoing NCS related to the time interval between PCI with bare-metal stent?

Background: In order to prevent thrombosis of bare-metal stents (BMS) placed during percutaneous coronary intervention (PCI), antiplatelet therapy is used. This poses a risk of bleeding, if surgery is needed during the antiplatelet therapy. The American College of Cardiology and the American Heart Association recommends delaying NCS for at least six weeks after PCI with BMS.

Study design: Retrospective observational study.

Setting: Mayo Clinic, Rochester, Minn.

Synopsis: Looking at 899 patients who had NCS within one year of PCI with BMS at the Mayo Clinic between Jan. 1, 1990, and Jan. 1, 2005, this study found that when NCS was done 30 days or less after PCI with BMS, the MACEs rate was 10.5%, compared with 2.8% when NCS was done 91 or more days after PCI with BMS. After a multivariable analysis, it also was shown bleeding events were not associated with time between PCI with BMS and NCS.

While the American College of Cardiology and the American Heart Association recommends delaying NCS for at least six weeks after PCI with BMS, waiting at least 90 days would permit completion of antiplatelet therapy and re-endothelialization of the stent.

Bottom line: The risk of MACEs with noncardiac surgery is lowest when performed at least 90 days after PCI with bare-metal stent.

Citation: Nuttall GA, Brown MJ, Stombaugh JW, et al. Time and cardiac risk of surgery after bare-metal stent, percutaneous coronary intervention. Anesthesiology. 2008;109: 588-595.

Should we screen extensively for cancer in patients with newly diagnosed venous thromboembolism (VTE)?

Background: It is well known VTE can be the first manifestation of previously undiagnosed cancer. Retrospective studies have suggested “limited” cancer screening, including a history and physical examination, along with basic blood work, adequately identifies malignancy in patients with unexplained VTE. However, more recent prospective studies have suggested more extensive screening, which includes imaging studies or tumor-marker measurement, can increase the rate of cancer detection.

Study design: Systematic review.

Setting: Literature search using MEDLINE, EMBASE, the Cochrane Register of Controlled Trials, and evidence-based medicine reviews.

Synopsis: Thirty-six studies of 9,516 patients with VTE reported the period prevalence of previously undiagnosed cancer from baseline to 12 months was 6.3% (95% confidence interval (CI) of 5.6% to 6.9%) in all patients with VTE, and was even higher in patients with unprovoked VTE, 10% (95% CI 8.6% to 11.3%). Of the 34 articles used for prevalence assessment, an extensive screening strategy using CT scans of the abdomen and pelvis increased the proportion of previously undiagnosed cancer detection from 49.4% (CI, 40.2% to 58.5%; limited screening) to 69.7% (CI, 61.1% to 77.8%) in patients with unprovoked VTE. Ultrasonography of the abdomen and pelvis and tumor-marker screening did not result in a clinically significant increase in the frequency of cancer detection.

Four studies compared the rate of detection of early-stage, previously undiagnosed cancer between the limited and extensive screening strategies. Extensive screening led to an absolute decrease in cancer-related mortality of 1.9%, but this difference was not statistically significant.

In this systematic review, there is a great deal of heterogeneity in the studies. Most of the studies did not look at whether an increase in detection of new malignant conditions resulted in a change in the detection rate of early-stage cancer, or a decrease in cancer-related morbidity, cancer-related mortality, or overall mortality. Furthermore, the studies did not assess the consequences of extensive screening, such as patient anxiety and discomfort, testing complications, burden of additional tests for false-positive results, or cost-effectiveness. However, it is important for hospitalists to recognize undiagnosed cancer is common in unexplained VTE and warrants at least a limited-screening approach with more extensive screening.

Bottom line: Although the prevalence of undiagnosed cancer is common in VTE, extensive screening did not offer a cancer-related mortality benefit. CT of the abdomen and pelvis did, however, lead to a greater number of cancer diagnoses in patients with unexplained VTE.

Citation: Carrier M, Le Gal G, Wells PS, Fergusson D, Ramsay T, Rodger MA. Systematic review: the Trousseau syndrome revisited: should we screen extensively for cancer in patients with venous thromboembolism? Ann Intern Med. 2008;149: 323-333.

Does the use of preadmission statins decrease the risk of death, bacteremia, and pulmonary complications in patients admitted with pneumonia?

Background: Both experimental and clinical studies have suggested statins improve outcomes in severe infections, such as sepsis. This is thought to be due to the antithrombotic, anti-inflammatory, and immunomodulatory effects of statins. However, previous studies on the effect of statins on pneumonia have conflicting outcomes.

Study design: Population-based cohort study of 29,900 patients.

Setting: Danish Health Registry.

Synopsis: Researchers studied patients ages 15 years and older hospitalized with pneumonia for the first time between January 1997 and December 2004. While statin users had more co-morbidities than nonusers, the 30-day mortality was 10.3% in users, compared with 15.7% in nonusers, corresponding to an adjusted 30-day mortality rate ratio of 0.69 (95% CI of 0.58-0.82). The 90-day mortality ratio was 16.8% in users, compared with 22.4% in nonusers, corresponding to an adjusted 90-day mortality ratio of 0.75 (95% CI of 0.65-0.86). Former use of statins was not associated with a decreased risk of death. The adjusted risk for bacteremia and pulmonary complications was not significantly different between nonusers and users.

Because this was an observational study, a causal relationship cannot be determined. Hospitalists should be alerted to the possibility statins might, in the future, prove to be a standard treatment modality in pneumonia. A randomized, double-blind trial might help further determine the effect of the acute use of statins on pneumonia outcomes.

Bottom line: Preadmission statin use is associated with a decrease in 30- and 90-day mortality in pneumonia.

Citation: Thomsen RW, Riis A, Kornum JB, Christensen S, Johnsen SP, Sorensen HT. Preadmission use of statins and outcomes after hospitalization with pneumonia. Arch Intern Med. 2008;168(19):2081-2087.

Do outcomes differ when patients with acute myocardial infarction (MI) undergo PCI with drug-eluting stents (DES) compared with bare-metal stents?

Background: Randomized trials comparing drug-eluting stents with bare-metal stents in acute MI have been limited in size and duration. Concern exists regarding higher mortality among patients with ST-elevation MI treated with DES.

Study design: Observational, cohort study.

Setting: Patients were identified from a state-mandated database, in which all PCI performed in Massachusetts are reported.

Synopsis: Between April 2003 and September 2004, 7,217 eligible patients underwent stenting for acute MI. They were assigned to either the DES group or the bare-metal stent (BMS) group using propensity score matching. Patients in the DES group had lower mortality at two years, compared to a matched cohort of patients in the BMS group with MI (10.7% vs. 12.8%; absolute risk difference, -2.1%, CI, -3.8% to -0.4%). A statistically significant difference was noted among patients with or without ST-elevation MI.

The rates of target vessel revascularization at two years with MI were significantly lower among patients receiving DES than among those receiving BMS (9.6% vs. 14.5%; risk difference, -4.9%; CI, -6.1% to -3.1%).

The study is limited by its observational nature and residual confounding bias after matching. Importantly, this study was performed to determine if DESs were harmful, and the finding of reduced mortality was unanticipated.

Bottom line: Although patients with acute MI treated with drug-eluting stents had lower mortality and repeat revascularization rates compared with bare-metal stents, this outcome merits confirmation in randomized trials.

Citation: Mauri L, Silbaugh TS, Garg P, et al. Drug-eluting or bare-metal stents for acute myocardial infarction. N Engl J Med. 2008;359 (13):1330-1342.

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