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1.
BMC Infect Dis ; 20(1): 23, 2020 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-31914940

RESUMO

BACKGROUND: The prevalence of diabetes mellitus continues to inexorably rise in the United States and throughout the world. Lower limb amputations are a devastating comorbid complication of diabetes mellitus. Osteomyelitis increases the risk of amputation fourfold and commonly presages death. Antimicrobial therapy for diabetic foot osteomyelitis (DFO) varies greatly, indicating that high quality data are needed to inform clinical decision making. Several small trials have indicated that the addition of rifampin to backbone antimicrobial regimens for osteomyelitis outside the setting of the diabetic foot results in 28 to 42% higher cure rates. METHODS/DESIGN: This is a prospective, randomized, double-blind investigation of the addition of 6 weeks of rifampin, 600 mg daily, vs. matched placebo (riboflavin) to standard-of-care, backbone antimicrobial therapy for DFO. The study population are patients enrolled in Veteran Health Administration (VHA), ages ≥18 and ≤ 89 years with diabetes mellitus and definite or probable osteomyelitis of the foot for whom an extended course of oral or intravenous antibiotics is planned. The primary endpoint is amputation-free survival. The primary hypothesis is that using rifampin as adjunctive therapy will lower the hazard rate compared with the group that does not use rifampin as adjunctive therapy. The primary hypothesis will be tested by means of a two-sided log-rank test with a 5% significance level. The test has 90% power to detect a hazard ratio of 0.67 or lower with a total of 880 study participants followed on average for 1.8 years. DISCUSSION: VA INTREPID will test if a rifampin-adjunctive antibiotic regimen increases amputation-free survival in patients seeking care in the VHA with DFO. A positive finding and its adoption by clinicians would reduce lower extremity amputations and their associated physical and emotional impact and reduce mortality for Veterans and for the general population with diabetic foot osteomyelitis. Given that rifampin-adjunctive regimens are currently employed for therapy for the majority of DFO cases in Europe, and only in a small minority of cases in the United States, the trial results will impact therapeutic decisions, even if the null hypothesis is not rejected. TRIAL REGISTRATION: Registered January 6, 2017 at ClinicalTrials.gov, NCT03012529.


Assuntos
Amputação , Pé Diabético/tratamento farmacológico , Osteomielite/tratamento farmacológico , Rifampina/uso terapêutico , Veteranos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Amputação/estatística & dados numéricos , Antibacterianos/uso terapêutico , Antibioticoprofilaxia , Pé Diabético/complicações , Pé Diabético/epidemiologia , Pé Diabético/cirurgia , Método Duplo-Cego , Feminino , Pé/microbiologia , Pé/patologia , Pé/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Osteomielite/complicações , Osteomielite/epidemiologia , Osteomielite/cirurgia , Placebos , Estudos Prospectivos , Prevenção Secundária/métodos , Veteranos/estatística & dados numéricos , Adulto Jovem
2.
Br J Haematol ; 188(3): 424-427, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31515797

RESUMO

Severity of cardiac involvement remains the leading determinant of survival in light chain (AL) amyloidosis. Until recently, cardiac response after treatment relied on reduction of N-terminal pro-brain natriuretic peptide (NT-proBNP). In this study, 94 patients with AL amyloidosis (baseline BNP ≥150 pg/ml) had BNP measured at 6 months following treatment. Median overall survival was not reached for cardiac response (≥50 pg/ml and ≥ 30% decrease in BNP), 9·2 years for cardiac stability (<50 pg/ml and <30% change in BNP) and 2·8 years for cardiac progression (≥50 pg/ml or ≥30% increase in BNP) (log-rank P < 0·001). Cardiac response and progression, as measured by BNP values, are significantly associated with survival in AL amyloidosis.

3.
J Vasc Surg ; 71(2): 567-574.e4, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31443977

RESUMO

OBJECTIVE: Although the effect of body mass index (BMI) on the treatment of infrainguinal peripheral artery disease has been reported, outcomes of patients on the upper end of the obesity spectrum, including morbid obesity (MO) and superobesity (SO), are unclear. Our goal was to analyze perioperative outcomes after lower extremity bypass (LEB) and peripheral vascular interventions (PVIs) in this population of patients. METHODS: The Vascular Quality Initiative was reviewed for all infrainguinal peripheral artery disease interventions from 2010 to 2017. All patients were categorized into four groups: nonobese (BMI 18.5-29.9 kg/m2), obese (BMI 30-39.9 kg/m2), morbidly obese (BMI 40-49.9 kg/m2), and superobese (BMI ≥50 kg/m2). Patient and case details were recorded. Multivariable analysis was used to analyze outcomes. For statistical analysis, MO and SO groups were combined. RESULTS: We identified 29,138 LEB cases (68.5% nonobese, 28.3% obese, 2.9% morbidly obese, 0.3% superobese) and 81,405 PVI cases (66.6% nonobese, 29.2% obese, 3.6% morbidly obese, 0.5% superobese). For both LEB and PVI, patients with MO and SO were more likely to be younger, female, nonsmokers, and ambulatory (P < .05). They also more often had diabetes, end-stage renal disease, congestive heart failure, and fewer previous inflow procedures (P < .05). LEB and PVI interventions in patients with MO and SO were less often elective and more often performed for tissue loss. Multivariable analysis showed that LEB in patients with MO and SO was not significantly associated with increased perioperative cardiac complications, return to the operating room, or mortality. Patients with MO and SO were significantly associated with increased surgical site infection (odds ratio, 1.43; 95% confidence interval, 1.02-1.98; P = .03) and increased respiratory complications (odds ratio, 1.6; 95% confidence interval, 1.11-2.31; P = .01). Multivariable analysis showed that MO and SO were not significantly associated with periprocedural access site hematoma, access site stenosis or occlusion, or mortality after PVI. CONCLUSIONS: MO and SO were significantly associated with increased incidence of wound infections and respiratory complications after LEB but were not significantly associated with increased incidence after PVI. Overall, patients with MO and SO have more comorbidities and more advanced presentation of vascular disease at the time of intervention, but MO and SO alone should not deter necessary and appropriate revascularization.

4.
Aging Male ; 23(1): 81-92, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30782054

RESUMO

Objective: The association between erectile dysfunction (ED), hypogonadism, cardiovascular disease, and type 2 diabetes is well documented, but long-term data are limited. The aim of this study is to investigate effects of long-term testosterone therapy (TTh) with testosterone undecanoate in men with hypogonadism and ED.Patients and methods: Observational, prospective registry of 805 hypogonadal men with different degrees of ED, evaluated by the International Index of Erectile Function - Erectile Function Domain. Four hundred and twelve patients underwent TTh, 393 patients served as controls, with an observation period up to 12 years.Results: TTh led to substantial and sustained reduction of ED; improvement in erectile function was significant for each successive year until year 9. This was accompanied by improvements in cardiometabolic risk factors and urinary function throughout the 12-year follow-up period. Benefits of TTh were stronger for patients with moderate/severe ED than for patients with no/minor ED. Incidence of prostate cancer, major adverse cardiovascular events, and mortality were significantly lower in men on TTh compared with untreated men.Conclusion: Long-term TTh for up to 12 years alleviates ED, improves cardiometabolic risk factors, and reduces prostate cancer. Patients must stay on TTh consistently for a long time to achieve maximum benefits of TTh.

5.
JAMA Netw Open ; 2(11): e1916003, 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31755948

RESUMO

Importance: Among patients diagnosed with diabetes, the lifetime incidence of foot ulcers is 15%. Infection is a common complication of foot ulcers, and 20% to 60% of infections result in diabetic foot osteomyelitis (DFO). Current treatment guidelines do not endorse any specific antibiotic agent for DFO, but small clinical trials suggest the addition of rifampin to antimicrobial regimens results in improved cure rates for osteomyelitis. Objective: To compare the clinical outcomes of patients treated for DFO in the Veterans Health Administration (VHA) with and without adjunctive rifampin. Design, Setting, and Participants: This observational cohort study used VHA databases to identify index DFO cases from January 1, 2009, through December 31, 2013, and analyzed patients alive and without high-level amputation at 90 days after diagnosis in whom antibiotic therapy was initiated within 6 weeks of diagnosis. Patients with death or major amputation within 90 days of diagnosis, who were not treated with systemic antibiotics dispensed by the VHA within 6 weeks of diagnosis, or who were treated at facilities where rifampin was not dispensed for DFO were excluded. The retrospective cohort to inform the planning of a multisite randomized clinical trial was first investigated in spring 2015; retrospective analysis was performed from February 2017 through September 2019. Exposures: Patients initiating rifampin therapy within 6 weeks of the DFO diagnosis and receiving the drug for at least 14 days within 90 days of diagnosis were considered treated with rifampin. Patients not administered rifampin within 90 days of diagnosis served as the comparator group. Main Outcomes and Measures: A combined end point of mortality or amputation within 2 years of diagnosis was analyzed. Differences in times to event were evaluated using log-rank tests. Differences in event rates were compared using χ2 tests and multivariable logistic regression. Results: The analysis population included 130 patients treated with rifampin and 6044 treated without rifampin (total of 6174; 6085 men [98.6%]; mean [SD] age, 64.9 [9.7] years). Lower event rates were observed among the rifampin group (35 of 130 [26.9%] vs 2250 of 6044 [37.2%]; P = .02). Patients treated with rifampin were younger (mean [SD] age, 62.2 [9.4] vs 64.9 [9.6] years), had fewer comorbidities (mean [SD] Charlson comorbidity index score, 3.5 [1.8] vs 4.0 [2.2]), had more infectious disease specialty consultations (63 of 130 [48.5%] vs 1960 of 6044 [32.4%]), and more often had Staphylococcus aureus identified in cultures (55 of 130 [42.3%] vs 1755 of 6044 [29.0%]) than patients not treated with rifampin. A logistic regression estimating the odds of events and controlling for these and other covariates yielded a significant association of rifampin (odds ratio, 0.65; 95% CI, 0.43-0.96; P = .04). Conclusions and Relevance: In this cohort study, patients administered rifampin experienced lower rates of death and amputation than patients not treated with rifampin, which remained significant after adjustment for confounders. These results coupled with existing evidence from small clinical trials suggest the addition of rifampin to current treatment regimens may be a useful antimicrobial option in the treatment of DFO.

6.
Int J Angiol ; 28(2): 124-129, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31384110

RESUMO

We identified factors that would lead to wound complications after open femoral exposure for endovascular abdominal aortic aneurysm repair (oEVAR). Using the National Surgical Quality Improvement Program dataset (2005-2014), we examined the patients who underwent oEVAR. Patients were stratified on whether they developed postoperative wound complications. Comparisons were made between group with wound complications and those without and adjusted analyses performed to identify variables that independently increased the risk of wound complications. There were 14,868 patients in the study cohort and 2.6% (384 patients) developed wound complications after EVAR. Among those with wound complications, 94% (360 patients) of patients had superficial and deep surgical site infection. Patients who had wound complication were likely to be younger (72.6 vs. 73.7 years old ( p = 0.02), functionally dependent (5.4 vs. 2.5%) ( p < 0.05), smoker (3 vs. 2.4%, p =0.03), female (4 vs. 2.2%), with significantly higher body mass index (31 vs. 28), and more commonly had diabetes (4 vs. 2.4%, p < 0.001) or renal failure (12 vs. 3%, p < 0.001). Although perioperative survival was similar, patients who had wound complications had significantly longer hospital length of stay (LOS) (7.3 ± 12 vs. 3.4 ± 5 days, p < 0.001). Up to 3% patients developed wound complications after open femoral exposure during EVAR with significantly higher LOS and therefore cost utilization.

7.
Am Heart J ; 216: 82-90, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31415994

RESUMO

Coronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting. STUDY DESIGN AND OBJECTIVES: Prospective, single-blind, randomized, active-control, multi-center study designed to assess the safety and efficacy of the novel Svelte sirolimus-eluting stent (SES) systems. A total of 1630 subjects with up to 3 target lesions will be randomized 1:1 to the Svelte SES versus either the Xience or Promus everolimus-eluting stents (control). Randomization will be stratified by whether or not a direct stenting strategy is planned by the investigator. The primary endpoint is target lesion failure (TLF) at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a non-inferiority test with a non-inferiority margin of 3.58%. Secondary clinical endpoints include individual components of TLF, stent thrombosis and measures of procedural resource utilization including contrast administration, fluoroscopy exposure and procedural resource utilization as well as costs. CONCLUSION: The OPTMIZE Trial will evaluate the safety, efficacy and clinical value of the novel Svelte SES in subjects with up to 3 lesions, and will provide a comparison of direct stenting between randomized devices.

8.
Eur J Vasc Endovasc Surg ; 58(4): 529-537, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31439432

RESUMO

OBJECTIVE: The choice for surgical revascularisation for aortoiliac occlusive disease is often tempered by patient comorbidities. This study compares peri-operative outcomes and the association between choice of operation and one year major adverse limb event (MALE) free survival and five year mortality. METHODS: The Vascular Study Group of New England (VSGNE) dataset for supra-inguinal bypass operations from 2009 to 2015 was queried. This study excluded cases with bypass other than aortofemoral (AFB), axillofemoral (AXB), and femorofemoral (FFB), and those with endovascular interventions or femoral endarterectomy. Cases combined with other procedures, indications other than occlusive disease, and missing pathology were also excluded. Patients were divided into three groups: AFB, AXB, and FFB. Thirty day post-operative death (POD) and adverse events were compared using univariable and multivariable analyses. One year MALE free survival was compared between groups with log rank test and Kaplan-Meier plot. Proportional hazard Cox regression was used for adjusted comparison of MALE free and five year survival. RESULTS: In total, 1,602 cases were included: 207 (12.9%) AXB; 872 (54.4%) AFB; 523 (32.6%) FFB. AXB patients were older with more comorbidities. Post-operative complications and POD rates were significantly higher for AXB (p < .05). On adjusted analyses, AXB increased the hazard of one year MALE (hazard ratio [HR] 1.76, 95% confidence interval [CI] 1.12-2.78; p = .014) and five year mortality (HR 1.54; 95% CI 1.11-2.41; p = .009). Both FFB and AFB had similar one year MALE free survival but significantly better one year MALE free survival than AXB. CONCLUSION: After adjusting for confounding variables, and while acknowledging limitations related to the VSGNE data set, FFB led to significantly lower rates of post-operative complications than AXB. FFB may serve as the extra-anatomical operation of choice in high risk patients with extensive disease, who cannot undergo AFB, provided that anatomy permits. AFB should be performed preferentially in low risk patients with appropriate anatomy. Owing to its higher complications rates, the study suggests that AXB should be limited to patients with no other option for revascularisation.

9.
Stat Med ; 38(21): 4112-4130, 2019 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-31256435

RESUMO

Two-way enriched design (TED) is a novel approach addressing placebo response in clinical trials. It is a two-stage, randomized, placebo-controlled trial design with enrichment in placebo non-responders and treatment responders at the second stage. All data from the first stage and data from placebo non-responders and treatment responders in the second stage are used for the final analysis of the treatment effect. The existing methods for the analysis of TED data include score tests with one, two, and three degrees of freedom. All these methods are only applicable to binary outcomes. However, there is an interest in continuous outcomes in clinical trials in psychiatry. In this manuscript, we apply some novel methods, including a repeated measures model, a weighted repeated measures model with weights from propensity score, and weights from K-means clustering, to analyze TED data for both binary outcomes and continuous outcomes. The simulation study indicates that the repeated measures model performs consistently well in preserving the type I error and achieving the minimum mean standard error as well as a higher power. The performance of the weighted repeated measures model with weights from K-means clustering improves with increasing sample size. Investigators can choose from these analytic approaches under different scenarios.

10.
ESC Heart Fail ; 6(5): 1085-1087, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31268222

RESUMO

In this observational analysis from the Practice Innovation and Clinical Excellence Registry®, we examined changes in guideline-directed medical therapies relative to changes in symptom severity in ambulatory patients with heart failure with reduced ejection fraction, finding change in medication more often occurring when patients were changing their New York Heart Association symptom severity, rather than during periods of stable symptoms. Additionally, despite being available for a year during the time of our analysis, the use of sacubitril/valsartan was extremely low, and most often added in the context of worsening symptoms, not how this drug was studied and not how the guidelines articulate its use.

11.
ESC Heart Fail ; 6(4): 784-792, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31268631

RESUMO

AIMS: Guidelines for management of patients with heart failure with mid-range ejection fraction [HFmrEF; left ventricular EF (LVEF) 41-49%] do not exist. Disagreement exists whether HFmrEF should be considered a distinct group. The aim of this study is to examine characteristics of patients with HFmrEF with HF with reduced EF (HFrEF; LVEF ≤ 40%) or preserved EF (HFpEF; LVEF ≥ 50%). METHODS AND RESULTS: We examined data collected in the American College of Cardiology's National Cardiovascular Data Registry (NCDR) Practice Innovation and Clinical Excellence (PINNACLE) Registry® for first HF patient visits between 1 May 2008 and 30 June 2016. Analysis was performed using ANOVA F-tests (or Kruskal-Wallis tests for non-normally distributed variables) for continuous parameters and χ2 tests for nominal covariates at the first diagnosed HF visit. Given the NCDR PINNACLE Registry® is a US-based registry, we opted to define HFmrEF as per the US guidelines, which define HFmrEF as LVEF 41-49% in contrast to European guidelines, which define HFmrEF as LVEF 40-49%. Among 1 103 386 patients with available data, 36.1% (N = 398 228) had HFrEF, 7.5% (N = 82 292) had HFmrEF, and 56.5% (N = 622 866) had HFpEF. Compared with patients with HFrEF or HFpEF, patients with HFmrEF had more prevalent coronary and peripheral artery disease and more history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass surgery (all P < 0.001). Patients with HFmrEF were also more likely to have atrial fibrillation/flutter, diabetes, and chronic kidney disease and to have a history of tobacco use (both P < 0.001). Among those with EF assessment prior to this analysis, only 4.8% (N = 1032) previously had HFrEF that improved to HFmrEF; 32.9% (N = 7072) had HFpEF previously and progressed to HFmrEF. Those patients who transitioned from HFpEF to HFmrEF had considerably more complex profiles and were less aggressively managed compared with those who remained with HFmrEF (all P < 0.001). CONCLUSIONS: In this large descriptive analysis, patients with HFmrEF had an atherothrombotic phenotype distinct from other forms of HF. Interventions aimed at treating coronary ischaemia and addressing prevalent risk factors may play a particularly important role in the management of patients with HFmrEF.

12.
Am J Hematol ; 94(10): 1098-1103, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31292986

RESUMO

Light chain (AL) amyloidosis is a protein folding disorder that can affect many different organ systems, in addition to the coagulation pathway. D-dimer, a measurement of fibrin degradation, is commonly elevated in hematologic malignancies, but the prevalence and significance of D-dimer elevation in AL amyloidosis is unknown. We conducted an analysis of 921 patients with AL amyloidosis that presented to the Boston University Amyloidosis Center. Baseline characteristics and laboratory data of the 897 patients included in the final cohort were analyzed. Four hundred twenty three patients (47%) had an elevated D-dimer (>0.5 µg/mL). Multivariate analysis demonstrated that a normal D-dimer level of ≤0.5 µg/mL, and a level of >0.5 µg/mL but <1 µg/mL, conferred a lower risk of mortality (HR 0.49 and 0.59, respectively) when compared to a D-dimer level ≥ 1 µg/mL. The increased risk of mortality in patients with a D-dimer level ≥ 1 µg/mL was present in all cardiac stages. The median overall survival based on D-dimer range of ≤0.5, >0.5 but <1, and ≥ 1 µg/mL was 5.86, 4.04, and 2.08 years, respectively (P < .001). This retrospective analysis demonstrates the high prevalence of D-dimer elevation in AL amyloidosis and confirms that this laboratory finding is independently associated with decreased survival.

13.
Sci Rep ; 9(1): 8552, 2019 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-31189919

RESUMO

Cardiac involvement in systemic amyloidosis (AL) occurs in ~50% of all AL patients. However once symptomatic heart failure develops, therapeutic options are limited thereby conferring a poor overall prognosis. The median survival is <6 months when AL patients are untreated for the underlying plasma cell dyscrasia. We thus sought to identify risk factors of increased mortality in treatment-naïve, AL cardiac amyloidosis with heart failure. Patients with biopsy-proven AL cardiac amyloid, who presented with heart failure and did not received prior AL treatment, were enrolled between 2004-2014, at the initial visit to the Amyloidosis Center at Boston University Medical Center. Routine laboratory tests, physical examination and echocardiography data were collected. There were 165 predominantly white (76.4%), and male (61%) patients, with a mean age of 61.6 ± 9.5 years. Median survival was 10.9 months (95% CI 6.2-14.7). By multivariate analysis increased relative wall thickness (RWT) [HR 6.70; 95% CI 2.45-18.30), older age (HR 1.04; 95% CI 1.01-1.06), higher New York Heart Association (NYHA) functional class (HR 1.50; 95% CI 1.02-2.2), log brain natriuretic peptide (BNP) levels (HR 1.45; 95% CI 1.15-1.81) and C-reactive protein (CRP) levels (HR 1.02; 95% CI 1.00-1.04) were significant predictors for increased mortality. In conclusion, in treatment-naïve, AL cardiac amyloidosis patients with heart failure symptoms who lack these high-risk features may have a better outcome. These findings might allow for better risk stratification although outcomes are still poor.

14.
J Vasc Surg ; 70(6): 1851-1861, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31147124

RESUMO

OBJECTIVE: Smoking has been associated with poor postoperative outcomes across various surgical procedures. However, the effect of quitting smoking preoperatively for elective operations is unclear. Our goal was to assess the temporal effect of smoking cessation before elective lower extremity bypass (LEB) and open abdominal aortic aneurysm (AAA) repair on perioperative outcomes. METHODS: The Vascular Quality Initiative was reviewed for all patients with a documented smoking history and who underwent an elective LEB or open AAA repair from 2010 to 2017. Patients were then categorized into three groups: long-term smoking cessation (LTSC; defined as quitting smoking ≥8 weeks before surgery), short-term smoking cessation (STSC; defined as quitting smoking < 8 weeks before surgery), and current smokers (CS). Patient and procedure details were recorded. Univariate and multivariate analysis for crude and propensity-matched data were used to compare outcomes among groups. RESULTS: We identified 15,950 patients with a documented smoking history who underwent an elective LEB (43.3% LTSC, 2.2% STSC, 54.5% CS) and 5215 patients who underwent an elective open AAA repair (42.9% LTSC, 2.4% STSC, 54.7% CS). LTSC patients compared with STSC and CS, respectively, were more often obese, diabetic, on aspirin, on a statin, had coronary artery disease, and had congestive heart failure, but were less likely to have chronic obstructive pulmonary disease (all P < .05). Perioperative outcomes demonstrated significant differences comparing LTSC with STSC and CS for myocardial infarction (3.4% vs 1.4% vs 1.4%), dysrhythmia (4.2% vs 2.5% vs 2.7%), 30-day mortality (1.6% vs .3% vs .9%), in-hospital mortality (1.1% vs 0% vs 0.5%; all P < .001) and congestive heart failure (1.8% vs .8% vs 1.5%; P = .003). There was no difference in outcomes after analysis of propensity-matched data for LTSC or STSC on any postoperative outcomes for LEB. For open AAA repair, LTSC compared with CS patients, respectively, were older, more often male, obese, on a statin, diabetic, and less frequently had chronic obstructive pulmonary disease (P < .05 for all). Perioperative outcomes demonstrated differences in pulmonary complications when comparing LTSC with STSC and CS (9.5% vs 8.0% vs 12.5%; P = .002). Multivariate analysis demonstrated that LTSC patients compared with CS were less likely to experience pulmonary complications (odds ratio, 0.65; 95% confidence interval, 0.53-0.79; P < .001). Propensity-matched multivariate analysis confirmed that LTSC remained significantly less likely to encounter pulmonary complications (odds ratio, 0.49; 95% confidence interval, 0.33-0.74; P = .001). CONCLUSIONS: In our propensity-matched, risk-adjusted cohort, LTSC and STSC were not associated with perioperative outcomes after elective LEB. LTSC was associated with a significantly decreased odds of pulmonary complications after elective open AAA repair. STSC was not associated with perioperative outcomes after elective open AAA repair. If time permits, a longer period of smoking cessation should be attempted before elective open AAA repair.

16.
J Vasc Surg ; 69(5): 1559-1565, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31010519

RESUMO

OBJECTIVE: Advancement in academic medicine is multifactorial. Our objectives were to characterize academic appointments in vascular surgery and to investigate what factors, particularly publications, influenced academic appointment. METHODS: Academic vascular surgeons at Accreditation Council for Graduate Medical Education vascular training programs or at primary sites of U.S. allopathic medical schools were included. Those with qualified titles, such as "adjunct" or a "clinical" prefix, were excluded. Sex, education, region, board certification, and affiliation details were recorded. Web of Science was queried for publication details and h-index. The h-index is a "personal impact factor" defined as "x" number of publications cited at least "x" number of times. After surgeons' information was deidentified, univariate and multivariable analyses were completed for academic appointment and appointment as division chief. RESULTS: There were 642 vascular surgeons who met criteria: 297 (46.3%) assistant professors, 150 (23.4%) associate professors, and 195 (30.4%) professors. There were 96 (15%) division chiefs and 10 (1.6%) chairs of surgery, and 83.2% were male. Surgeons worked in the Northeast (33.5%), Southern (32.6%), Central (20.1%), and Western (13.9%) United States. The mean (±standard deviation) number of publications was 13.7 ± 15.4 for assistant professors, 33.9 ± 28.8 for associate professors, and 86.8 ± 63.6 for professors (P < .001). Mean number of first or last author publications was 5.3 ± 6.4 for assistant professors, 12.2 ± 12.7 for associate professors, and 38.7 ± 35.3 for professors (P < .001). Mean h-index was 5.9 ± 5.4 for assistant professors, 12 ± 7.7 for associate professors, and 24.9 ± 12.6 for professors (P < .001). In multivariable analysis, vascular surgery board certification (adjusted odds ratio [OR], 6.08; 95% confidence interval [CI], 1.15-32.2; P = .03), academic appointment at a public medical school (OR, 1.99; 95% CI, 1.18-3.37; P = .01), years since medical school graduation (OR, 1.13; 95% CI, 1.09-1.18; P < .001, per year), and number of publications (OR, 1.05; 95% CI, 1.03-1.06; P < .001, per publication) were independently associated with associate professor. Factors independently associated with professor were years since medical school graduation (OR, 1.18; 95% CI, 1.12-1.24; P < .001, per year) and number of first or last author publications (OR, 1.05; 95% CI, 1.02-1.09; P = .003, per publication). Appointment as division chief was independently associated with h-index (OR, 1.04; 95% CI, 1.01-1.08; P = .016, per point). CONCLUSIONS: Total number of publications was independently associated with associate professor, with number of first or last author publications particularly important for professor. The h-index was not independently associated with academic appointment, but it was for appointment as division chief. This study provides relevant data for promotional guidance in academic vascular surgery.


Assuntos
Docentes de Medicina/normas , Publicações Periódicas como Assunto/normas , Seleção de Pessoal/normas , Cirurgiões/normas , Procedimentos Cirúrgicos Vasculares/normas , Autoria/normas , Bibliometria , Mobilidade Ocupacional , Comportamento de Escolha , Feminino , Humanos , Masculino , Estudos Retrospectivos , Estados Unidos
17.
Diabetes Care ; 42(6): 1104-1111, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30862651

RESUMO

OBJECTIVE: Type 2 diabetes (T2D) is a public health threat. Prediabetes represents a window of opportunity for intervention to prevent T2D. Men with T2D and prediabetes often have low testosterone. Since testosterone improves glycemic control in T2D, we investigated whether testosterone therapy (TTh) in men with hypogonadism and prediabetes prevents progression to T2D. RESEARCH DESIGN AND METHODS: Three hundred and sixteen men with prediabetes (defined as HbA1c 5.7-6.4%) and total testosterone levels ≤12.1 nmol/L combined with symptoms of hypogonadism were analyzed. Two hundred and twenty-nine men received parenteral testosterone undecanoate (T-group), and 87 men with hypogonadism served as untreated control subjects. Metabolic and anthropometric parameters were measured twice yearly for 8 years. RESULTS: HbA1c decreased by 0.39 ± 0.03% (P < 0.0001) in the T-group and increased by 0.63 ± 0.1% (P < 0.0001) in the untreated group. In the T-group, 90% achieved normal glucose regulation (HbA1c <5.7%). In the untreated group, 40.2% progressed to T2D (HbA1c >6.5%). TTh was also associated with significant improvements in fasting glucose, triglyceride:HDL ratio, triglyceride-glucose index, lipid accumulation product, total cholesterol, LDL, HDL, non-HDL, triglycerides, and Aging Males' Symptoms (AMS) scale. Significant deterioration in all these parameters was seen in the untreated group. Mortality was 7.4% in the T-group and 16.1% in the untreated group (P < 0.05). The incidence of nonfatal myocardial infarction was 0.4% in the T-group and 5.7% in the untreated group (P < 0.005). CONCLUSIONS: Long-term TTh completely prevents prediabetes progression to T2D in men with hypogonadism and improves glycemia, lipids, and AMS score. TTh holds tremendous potential for the large and growing population of men with prediabetes and hypogonadism.

18.
J Neurol Sci ; 400: 122-128, 2019 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-30927619

RESUMO

GOAL: We performed a systematic review and meta-analysis aiming to clarify the relationship between acid-suppressive medication (ASM) and the risk of pneumonia in acute stroke. METHODS: The included studies examined patients with an acute ischemic and/or hemorrhagic stroke, assessed the relationship of one or both groups of ASM, histamine-2 receptor antagonist (H2RA) and proton-pump inhibitor (PPI), as a variable of interest, and used the occurrence of hospital-acquired pneumonia (HAP) as an outcome measure. The search was conducted in MEDLINE, Cochrane, Embase, and Google Scholar. Random-effects meta-analyses were used to obtain pooled estimates of the effect. RESULTS: 5 retrospective cohort-studies fulfilled study criteria. The results revealed a higher risk of pneumonia for both, patients receiving PPI (adjusted relative risk [RR] 2.37, 95% confidence interval [CI] 1.36-4.17, I2 0%) and H2RAs (adjusted RR 1.73, 95% CI 0.74-4.25, I2 68.3%), although the latter did not reach statistical significance. A comparison of the overall acid versus non-acid groups using unadjusted values yielded likewise an increased risk for pneumonia for patients receiving ASM (unadjusted RR 4.65, 95% CI 1.64-13.16, I2 93.3%). CONCLUSION: Results of this meta-analysis show an increased risk for HAP in acute stroke patients who receive ASM, particularly those exposed to PPIs. Larger, well-controlled studies in acute stroke populations are needed to establish a clearer association between ASM and HAP. These results, however, urge caution when prescribing ASM - especially to stroke patients considered to be at high risk for pneumonia.

19.
JAMA Cardiol ; 4(3): 265-271, 2019 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-30785590

RESUMO

Importance: One-third of Medicare beneficiaries are enrolled in Medicare Advantage (MA), Medicare's private plan option. Medicare Advantage incentivizes performance on evidence-based care, but limited information exists using reliable clinical data to determine whether this translates into better quality for patients with coronary artery disease (CAD) enrolled in MA compared with those enrolled in traditional fee-for-service (FFS) Medicare. Objective: To determine differences in evidence-based secondary prevention treatments and intermediate outcomes among patients with CAD enrolled in MA vs FFS Medicare. Design, Setting, and Participants: In this observational, retrospective, cohort study, deidentified data from patients 18 years or older diagnosed as having CAD between January 1, 2013, and May 1, 2014, at cardiology practices participating in the Practice Innovation and Clinical Excellence (PINNACLE) registry were studied, including 35 563 patients enrolled in MA and 172 732 enrolled in FFS Medicare. Data were analyzed from March to July 2018. Exposures: Medicare Advantage enrollment. Main Outcomes and Measures: Medication prescription patterns among eligible patients and intermediate outcomes, including blood pressure and low-density lipoprotein cholesterol. Results: Of the 35 563 patients with CAD enrolled in MA, 20 193 (56.8%) were male, and the mean (SD) age was 76.7 (7.6) years; of the 172 732 patients with CAD enrolled in FFS Medicare, 100 025 (57.9%) were male, and the mean (SD) age was 77.5 (8.0) years. Patients enrolled in MA were younger, less likely to be white, and more likely to be female and to have heart failure, diabetes, and chronic kidney disease compared with those enrolled in FFS Medicare. Compared with FFS Medicare beneficiaries, MA beneficiaries were more likely to receive secondary prevention treatments, including ß-blockers (80.6% vs 78.8%; P < .001), angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (70.7% vs 65.1%; P < .001), and statins (68.4% vs 64.5%; P < .001). Patients enrolled in MA were also more likely to receive all 3 medications when eligible (48.9% vs 40.4%; P < .001). After adjustment, MA beneficiaries had higher odds of receiving guideline-recommended therapy compared with FFS Medicare beneficiaries for ß-blockers (odds ratio, 1.10; 95% CI, 1.04-1.17; P = .002), angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (odds ratio, 1.13; 95% CI, 1.08-1.19; P < .001), and all 3 medications (odds ratio, 1.23; 95% CI, 1.001-1.50; P = .047). There were no significant differences in intermediate outcomes between those enrolled in MA and FFS Medicare, including systolic and diastolic blood pressure and low-density lipoprotein cholesterol levels. Conclusions and Relevance: Among patients with CAD in the PINNACLE registry, MA beneficiaries had more comorbidities than FFS Medicare beneficiaries and were more likely to receive secondary prevention treatments. However, this did not translate into differences in intermediate outcomes. These findings suggest that MA plans may drive improvements in process-based quality measures for Medicare beneficiaries, although this may have a limited effect on improving patient outcomes over FFS Medicare.


Assuntos
Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/tratamento farmacológico , Planos de Pagamento por Serviço Prestado/normas , Medicare Part C/normas , Antagonistas Adrenérgicos beta/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Pressão Sanguínea/fisiologia , Cardiologia , Estudos de Coortes , Comorbidade , Doença da Artéria Coronariana/prevenção & controle , Diabetes Mellitus/tratamento farmacológico , Prática Clínica Baseada em Evidências , Planos de Pagamento por Serviço Prestado/estatística & dados numéricos , Feminino , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Lipoproteínas LDL/sangue , Masculino , Medicare Part C/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Insuficiência Renal Crônica/tratamento farmacológico , Estudos Retrospectivos , Estados Unidos/epidemiologia
20.
J Biopharm Stat ; 29(6): 1130-1133, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30794042

RESUMO

A Sequential Parallel Comparison Design has two stages, the first comparing drug to placebo and the second comparing drug to placebo among patients who did not respond to placebo in the first stage. The paper, Statistical Inference Problems in Sequential Parallel Comparison Designs, claims that the estimate of the treatment difference in the second stage is biased and that under certain circumstances, a suggested hypothesis test will reject the null hypothesis when it should be accepted. This rejoinder argues that the estimate in the second stage is not biased when the true target of estimation (estimand) is properly understood. Further, the null hypothesis that the authors posit is not the correct null hypothesis for clinical trials, and in the situation, they describe that the treatment should be considered to be effective.

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