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Residual Shunt After Patent Foramen Ovale Closure and Long-Term Stroke Recurrence: A Prospective Cohort Study: Annals of Internal Medicine: Vol 172, No 11
Background: Residual shunt is observed in up to 25% of patients after patent foramen ovale (PFO) closure, but its long-term influence on stroke recurrence currently is unknown. Objective: To investigate the association of residual shunt after PFO closure with the incidence of recurrent stroke and transient ischemic attack (TIA). Design: Prospective cohort study comparing stroke or TIA recurrence in patients with and without residual shunt after PFO closure. Setting: Single hospital center. Participants: 1078 consecutive patients (mean age, 49.3 years) with PFO-attributable cryptogenic stroke who were undergoing percutaneous PFO closure were followed for up to 11 years. Measurements: Residual shunt was evaluated by transthoracic echocardiography with saline contrast. Primary outcome was a composite of the first recurrent ischemic stroke or TIA after PFO closure. Results: Compared with complete closure, the presence of residual shunt after PFO closure was associated with an increased incidence of recurrent stroke or TIA: 2.32 versus 0.75 events per 100 patient-years (hazard ratio [HR], 3.05 [95% CI, 1.65 to 5.62]; P < 0.001). This result remained robust after adjustment for important covariates, namely age; study period; device; presence of atrial septal aneurysm, hypertension, hyperlipidemia, diabetes, hypercoagulability, or hypermobile septum; and medication use (HR, 3.01 [CI, 1.59 to 5.69]; P < 0.001). Further stratification based on shunt size revealed that moderate or large residual shunts were associated with a higher risk for stroke or TIA recurrence (HR, 4.50 [CI, 2.20 to 9.20]; P < 0.001); the result for small residual shunts was indeterminate (HR, 2.02 [CI, 0.87 to 4.69]; P = 0.102). Limitation: Nonrandomized study with potential unmeasured confounding. Conclusion: Among patients undergoing PFO closure to prevent future stroke, the presence of residual shunt, particularly a moderate or large residual shunt, was associated with an increased risk for stroke or TIA recurrence. Primary Funding Source: National Institutes of Health.
Comparative Pricing of Branded Tenofovir Alafenamide–Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate–Emtricitabine for HIV Preexposure Prophylaxis: A Cost-Effectiveness Analysis: Annals of Internal Medicine: Vol 172, No 9
Background: Tenofovir alafenamide–emtricitabine (F/TAF) was recently approved as a noninferior and potentially safer option than tenofovir disoproxil fumarate–emtricitabine (F/TDF) for HIV preexposure prophylaxis (PrEP) in the United States. Objective: To estimate the greatest possible clinical benefits and economic savings attributable to the improved safety profile of F/TAF and the maximum price payers should be willing to pay for F/TAF over generic F/TDF. Design: Cost-effectiveness analysis. Data Sources: Published literature on F/TDF safety (in persons with and those without HIV) and the cost and quality-of-life effects of fractures and end-stage renal disease (ESRD). Target Population: Age-stratified U.S. men who have sex with men (MSM) using PrEP. Time Horizon: Five years. Perspective: Health care sector. Intervention: Preexposure prophylaxis with F/TAF versus F/TDF. Outcome Measures: Fractures averted, cases of ESRD averted, quality-adjusted life-years (QALYs) saved, costs, incremental cost-effectiveness ratios (ICERs), and maximum justifiable price for F/TAF compared with generic F/TDF. Results of Base-Case Analysis: Over a 5-year horizon, compared with F/TDF, F/TAF averted 2101 fractures and 25 cases of ESRD for the 123 610 MSM receiving PrEP, with an ICER of more than $7 million per QALY. At a 50% discount for generic F/TDF ($8300 per year) and a societal willingness to pay up to $100 000 per QALY, the maximum fair price for F/TAF was $8670 per year. Results of Sensitivity Analysis: Among persons older than 55 years, the ICER for F/TAF remained more than $3 million per QALY and the maximum permissible fair price for F/TAF was $8970 per year. Results were robust to alternative time horizons and PrEP-using population sizes. Limitation: Intermittent use and on-demand PrEP were not considered. Conclusion: In the presence of a generic F/TDF alternative, the improved safety of F/TAF is worth no more than an additional $370 per person per year. Primary Funding Source: National Institute of Allergy and Infectious Diseases, National Institute on Drug Abuse, National Institute of Mental Health, and Massachusetts General Hospital Executive Committee on Research.
Altered Risk for Cardiovascular Events With Changes in the Metabolic Syndrome Status: A Nationwide Population-Based Study of Approximately 10 Million Persons: Annals of Internal Medicine: Vol 171, No 12
Background: Population-scale evidence for the association between dynamic changes in metabolic syndrome (MetS) status and alterations in the risk for major adverse cardiovascular events (MACE) is lacking. Objective: To investigate whether recovery from or development of MetS in a population is associated with an altered risk for MACE. Design: Nationwide cohort study. Setting: An analysis based on the National Health Insurance Database of Korea. Participants: A total of 27 161 051 persons who received national health screenings from 2009 to 2014 were screened. Those with a history of MACE were excluded. We determined the MetS status of 9 553 042 persons using the following harmonizing criteria: MetS-chronic (n = 1 486 485), MetS-developed (n = 587 088), MetS-recovery (n = 538 806), and MetS-free (n = 6 940 663). Measurements: The outcome was the occurrence of MACE, including acute myocardial infarction, revascularization, and acute ischemic stroke, identified from the claims database. The incidence rate ratios (IRRs) were calculated with adjustments for body mass index, comorbidity scores, previous metabolic variables, and other clinical or demographic variables. Results: At a median follow-up of 3.54 years, the MetS-recovery group (incidence rate, 4.55 per 1000 person-years) had a significantly lower MACE risk (adjusted IRR, 0.85 [95% CI, 0.83 to 0.87]) than that of the MetS-chronic group (incidence rate, 8.52 per 1000 person-years). The MetS-developed group (incidence rate, 6.05 per 1000 person-years) had a significantly higher MACE risk (adjusted IRR, 1.36 [CI, 1.33 to 1.39]) than that of the MetS-free group (incidence rate, 1.92 per 1000 person-years). Among the MetS components, change in hypertension was associated with the largest difference in MACE risk. Limitation: Limited assessment of mortality and short follow-up. Conclusion: Recovery from MetS was significantly associated with decreased risk for MACE, whereas development of MetS was associated with increased risk. Primary Funding Source: Korea Healthcare Technology R&D Project, Ministry of Health and Welfare, Republic of Korea.
High-Intensity Versus Low-Intensity Surveillance for Patients With Colorectal Adenomas: A Cost-Effectiveness Analysis: Annals of Internal Medicine: Vol 171, No 9
Background: Surveillance of patients with colorectal adenomas has limited long-term evidence to support current practice. Objective: To compare the lifetime benefits and costs of high- versus low-intensity surveillance. Design: Microsimulation model. Data Sources: U.S. cancer registry, cost data, and published literature. Target Population: U.S. patients aged 50, 60, or 70 years with low-risk adenomas (LRAs) (1 to 2 small adenomas) or high-risk adenomas (HRAs) (3 to 10 small adenomas or ≥1 large adenoma) removed after screening with colonoscopy or fecal immunochemical testing (FIT). Time Horizon: Lifetime. Perspective: Societal. Intervention: No further screening or surveillance, routine screening after 10 years, low-intensity surveillance (10 years after LRA removal and 5 years after HRA removal), and high-intensity surveillance (5 years after LRA removal and 3 years after HRA removal). Outcome Measures: Colorectal cancer (CRC) incidence and incremental cost-effectiveness. Results of Base-Case Analysis: Without surveillance or screening, lifetime CRC incidence for patients aged 50 years was 10.9% after LRA removal and 17.2% after HRA removal at screening colonoscopy. Subsequent colonoscopic screening, low-intensity surveillance, or high-intensity surveillance decreased incidence by 39%, 46% to 48%, and 55% to 56%, respectively. Incidence of CRC and surveillance benefits were higher for adenomas detected at FIT screening and lower for older patients. High-intensity surveillance cost less than $30 000 per quality-adjusted life-year (QALY) gained compared with low-intensity surveillance. Results of Sensitivity Analysis: High-intensity surveillance cost less than $100 000 per QALY gained in most alternative scenarios for adenoma recurrence, CRC incidence, longevity, quality of life, screening ages, surveillance ages, test performance, disutilities, and cost. Limitation: Few surveillance outcome data exist. Conclusion: The model suggests that high-intensity surveillance as recommended in the United States provides modest but clinically relevant benefits over low-intensity surveillance at acceptable cost. Primary Funding Source: National Cancer Institute.
Risks and Benefits of Dolutegravir- and Efavirenz-Based Strategies for South African Women With HIV of Child-Bearing Potential: A Modeling Study: Annals of Internal Medicine: Vol 170, No 9
Background: Dolutegravir is superior to efavirenz for HIV antiretroviral therapy (ART) but may be associated with an increased risk for neural tube defects (NTDs) in newborns if used by women at conception. Objective: To project clinical outcomes of ART policies for women of child-bearing potential in South Africa. Design: Model of 3 strategies: efavirenz for all women of child-bearing potential (EFV), dolutegravir for all women of child-bearing potential (DTG), or World Health Organization (WHO)-recommended efavirenz without contraception or dolutegravir with contraception (WHO approach). Data Sources: Published data on NTD risks (efavirenz, 0.05%; dolutegravir, 0.67% [Tsepamo study]), 48-week ART efficacy with initiation (efavirenz, 60% to 91%; dolutegravir, 96%), and age-stratified fertility rates (2 to 139 per 1000 women). Target Population: 3.1 million South African women with HIV (aged 15 to 49 years) starting or continuing first-line ART, and their children. Time Horizon: 5 years. Perspective: Societal. Intervention: EFV, DTG, and WHO approach. Outcome Measures: Deaths among women and children, sexual and pediatric HIV transmissions, and NTDs. Results of Base-Case Analysis: Compared with EFV, DTG averted 13 700 women's deaths (0.44% decrease) and 57 700 sexual HIV transmissions, but increased total pediatric deaths by 4400 because of more NTDs. The WHO approach offered some benefits compared with EFV, averting 4900 women's deaths and 20 500 sexual transmissions while adding 300 pediatric deaths. Overall, combined deaths among women and children were lowest with DTG (358 000 deaths) compared with the WHO approach (362 800 deaths) or EFV (367 300 deaths). Results of Sensitivity Analysis: Women's deaths averted with DTG exceeded pediatric deaths added with EFV unless dolutegravir-associated NTD risk was 1.5% or greater. Limitation: Uncertainty in NTD risks and dolutegravir efficacy in resource-limited settings, each examined in sensitivity analyses. Conclusion: Although NTD risks may be higher with dolutegravir than efavirenz, dolutegravir will lead to many fewer deaths among women, as well as fewer overall HIV transmissions. These results argue against a uniform policy of avoiding dolutegravir in women of child-bearing potential. Primary Funding Source: National Institutes of Health, National Institute of Allergy and Infectious Diseases and Eunice Kennedy Shriver National Institute of Child Health and Human Development; Massachusetts General Hospital; and Harvard University Center for AIDS Research.
Local Area Variation in Morbidity Among Low-Income, Older Adults in the United States: A Cross-sectional Study: Annals of Internal Medicine: Vol 171, No 7
Background: Recent studies have reported that low-income adults living in more affluent areas of the United States have longer life expectancies. Less is known about the relationship between the affluence of a geographic area and morbidity of the low-income population. Objective: To evaluate the association between the prevalence of chronic conditions among low-income, older adults and the economic affluence of a local area. Design: Cross-sectional association study. Setting: Medicare in 2015. Participants: 6 363 097 Medicare beneficiaries aged 66 to 100 years with a history of low-income support under Medicare Part D. Measurements: Adjusted prevalence of 48 chronic conditions was computed for 736 commuting zones (CZs). Factor analysis was used to assess spatial covariation of condition prevalence and to construct a composite condition prevalence index for each CZ. The association between morbidity and area affluence was measured by comparing the average of condition prevalence index across deciles of median CZ house values. Results: The mean age of study participants was 77.7 years (SD, 8.2); 67% were women, and 61% were white. The crude prevalence of 48 chronic conditions ranged from 72.5 per 100 for hypertension to 0.6 per 100 for posttraumatic stress disorder. The prevalence of these 48 chronic conditions was highly spatially correlated. Composite condition prevalence was on average substantially lower in more affluent CZs. Limitation: Low-income status measured on the basis of receipt of Medicare Part D low-income subsidies and not capturing persons not enrolled in Medicare Part D. Conclusion: Low-income, older adults living in more affluent areas of the country are healthier, and areas with poor health in the low-income, older adult population tend to have a high prevalence of most chronic conditions. Primary Funding Source: National Institute on Aging.
Medicare Spending and the Adequacy of Support With Daily Activities in Community-Living Older Adults With Disability: An Observational Study: Annals of Internal Medicine: Vol 170, No 12
Background: Identifying factors that affect variation in health care spending among older adults with disability may reveal opportunities to better address their care needs while offsetting excess spending. Objective: To quantify differences in total Medicare spending among older adults with disability by whether they experience negative consequences due to inadequate support with household activities, mobility, or self-care. Design: Observational study of in-person interviews and linked Medicare claims. Setting: United States, 2015. Participants: 3716 community-living older adults who participated in the 2015 NHATS (National Health and Aging Trends Study) and survived for 12 months. Measurements: Total Medicare spending by spending quartile in multivariable regression models that adjusted for individual characteristics. Results: Negative consequences were experienced by 18.3% of participants with disability in household activities, 25.6% with mobility disability, and 20.0% with self-care disability. Median Medicare spending was higher for those who experienced negative consequences due to household ($4866 vs. $4095), mobility ($7266 vs. $4115), and self-care ($10 935 vs. $4436) disability versus those who did not. In regression-adjusted analyses, median spending did not differ appreciably for participants who experienced negative consequences in household activities ($338 [95% CI, −$768 to $1444]), but was higher for those with mobility ($2309 [CI, $208 to $4409]) and self-care ($3187 [CI, $432 to $5942]) disability. In the bottom-spending quartile, differences were observed for self-care only ($1460 [CI, $358 to $2561]). No differences were observed in the top quartile. Limitation: This observational study could not establish causality. Conclusion: Inadequate support for mobility and self-care is associated with higher Medicare spending, especially in the middle and lower ends of the spending distribution. Better support for the care needs of older adults with disability could offset some Medicare spending. Primary Funding Source: The Commonwealth Fund.
Should This Woman With Dense Breasts Receive Supplemental Breast Cancer Screening?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 169, No 7
Breast cancer will develop in 12% of women during their lifetime and is the second leading cause of cancer death among U.S. women. Mammography is the most commonly used tool to screen for breast cancer. Considerable uncertainty exists regarding the age at which to begin screening and the optimal screening interval. Breast density is a risk factor for breast cancer. In addition, for women with dense breasts, small tumors may be missed on mammography and the sensitivity of screening is diminished. At the time of publication, 35 states had passed laws mandating that breast density be reported in the letters that radiologists send to women with their mammogram results. The mandated language may be challenging for patients to understand, and such reporting may increase worry for women who are told that their risk for breast cancer is higher than average on the basis of breast density alone. The U.S. Preventive Services Task Force and the American College of Radiology (ACR) have each issued guidelines that address breast cancer screening for women with dense breasts. Both organizations found insufficient evidence to recommend for or against magnetic resonance screening, whereas the ACR advises consideration of ultrasonography for supplemental screening. In this Beyond the Guidelines, 2 experts—a radiologist and a general internist—discuss these controversies. In particular, the discussants review the role of supplemental breast cancer screening, including breast ultrasonography or magnetic resonance imaging for women with dense breasts. Finally, the experts offer specific advice for a patient who finds her mammography reports confusing.
Self-reported Physical Health of Women Who Did and Did Not Terminate Pregnancy After Seeking Abortion Services: A Cohort Study: Annals of Internal Medicine: Vol 171, No 4
Background: Research demonstrates worse short-term morbidity and mortality associated with childbirth than with abortion, but little research has examined long-term physical health in women with unwanted pregnancies after abortion versus childbirth. Objective: To examine the physical health of women who seek and receive or are denied abortion. Design: Prospective cohort study. Setting: 30 U.S. abortion facilities from 2008 to 2010. Participants: Of 1132 women seeking abortion who consented to participate, 874 were included in this analysis (328 who had first-trimester abortion, 383 who had second-trimester abortion, and 163 who gave birth). Measurements: Self-reported overall health; chronic abdominal, pelvic, back, and joint pain; chronic headaches or migraines; obesity; asthma; gestational and nongestational hypertension and diabetes; and hyperlipidemia were assessed semiannually for 5 years. Mortality was assessed by using verbal autopsy and public records. Results: No significant differences were observed in self-rated health or chronic pain after first-trimester versus second-trimester abortion. At 5 years, 27% (95% CI, 21% to 34%) of women who gave birth reported fair or poor health compared with 20% (CI, 16% to 24%) of women who had first-trimester abortion and 21% (CI, 18% to 25%) who had second-trimester abortion. Women who gave birth also reported more chronic headaches or migraines and joint pain, but experienced similar levels of other types of chronic pain and obesity. Gestational hypertension was reported by 9.4% of participants who gave birth. Eight of 1132 participants died during follow-up, 2 in the postpartum period. Maternal mortality did not differ statistically by group. Limitation: Self-reported outcome measures, uncertain generalizability, and 41% loss to follow-up at 5 years. Conclusion: Although some argue that abortion is detrimental to women's health, these study data indicate that physical health is no worse in women who sought and underwent abortion than in women who were denied abortion. Indeed, differences emerged suggesting worse health among those who gave birth. Primary Funding Source: An anonymous foundation.
Percutaneous Closure Versus Medical Treatment in Stroke Patients With Patent Foramen Ovale: A Systematic Review and Meta-analysis: Annals of Internal Medicine: Vol 168, No 5
Background: New evidence emerged recently regarding the percutaneous closure of patent foramen ovale (PFO) to prevent recurrent stroke in patients with cryptogenic stroke. Purpose: To compare risks for recurrent cerebrovascular events in adults with PFO and cryptogenic stroke who underwent PFO closure versus those who received medical therapy alone. Data Sources: PubMed, Scopus, and Google Scholar from 1 December 2004 through 14 September 2017; references of eligible studies; relevant scientific session abstracts; and cardiology Web sites. Study Selection: Randomized controlled trials, published in English, that compared PFO closure using a currently available device with medical treatment alone and that reported, at minimum, the rates of stroke or transient ischemic attack (TIA) or of new-onset atrial fibrillation (AF) or atrial flutter (AFL). Data Extraction: 2 investigators independently extracted study data and assessed study quality. Data Synthesis: 4 of 5 trials comparing PFO closure with medical therapy used commercially available devices. These 4 trials, involving 2531 patients, found that PFO closure reduced the risk for the main outcome of stroke or TIA (risk difference [RD], −0.029 [95% CI, −0.050 to −0.007]) and increased the risk for new-onset AF or AFL (RD, 0.033 [CI, 0.012 to 0.054]). The beneficial effect of PFO closure was associated with larger interatrial shunts (P = 0.034). Limitation: Trials were not double-blind, and inclusion criteria were heterogeneous. Conclusion: Compared with medical treatment, PFO closure prevents recurrent stroke and TIA but increases the incidence of AF or AFL in PFO carriers with cryptogenic stroke. Primary Funding Source: Italian Ministry of Education, University and Research (MIUR). (PROSPERO: CRD42017074686)