Meta-Analysis Comparing Endovascular Treatment Modalities for Femoropopliteal Peripheral Artery Disease.

Endovascular interventions are commonly utilized for treatment of femoropopliteal peripheral artery disease. The relative efficacy of these interventions remains unclear. A Bayesian network meta-analysis was performed comparing 5 endovascular treatment modalities: balloon angioplasty (BA), bare metal stent (BMS), covered stent (CS), drug-coated balloon (DCB), drug-eluting stent (DES) for femoropopliteal peripheral artery disease. The primary efficacy end points were freedom from target lesion revascularization (TLR) and primary patency at 12 months. BA was the reference treatment. Twenty-two trials including 4,381 participants provided data on TLR. Sixteen trials including 3,691 participants provided data on primary patency. Point estimates for DCB suggested that it was the most efficacious treatment for freedom from TLR (odds ratio [OR] 4.23; 95% credible intervals [CrI] 2.43 to 7.66) followed by CS (OR 3.65; 95% CrI 1.11 to 12.55), DES (OR 2.64; 95% CrI 0.72 to 9.77), and BMS (OR 2.3; 95% CrI 1.11 to 4.76). Similarly, point estimates for primary patency were highest with DES (OR 8.93; 95% CrI 3.04, 27.14) followed by CS (OR 3.91; 95% CrI 1.18, 13.84), DCB (OR 3.32; 95% CrI 1.8, 6.25), and BMS (OR 3.5; 95% CrI 1.58, 7.99). In conclusion, DCB has the lowest need for TLR whereas DES has the highest primary patency rate. DCB, CS, and BMS were associated with significant reductions in TLR compared with BA, whereas DCB, DES, CS, and BMS were associated with significantly improved primary patency compared with BA.

Relative Costs of Surgical and Transcatheter Aortic Valve Replacement and Medical Therapy.

BACKGROUND: The number of patients treated for aortic valve disease in the United States is increasing rapidly. Transcatheter aortic valve replacement (TAVR) is supplanting surgical aortic valve replacement (SAVR) and medical therapy (MT). The economic implications of these trends are unknown. Therefore, we undertook to determine the costs, inpatient days, and number of admissions associated with treating aortic valve disease with SAVR, TAVR, or MT. METHODS: Using the Nationwide Readmissions Database, we identified patients with aortic valve disease admitted 2012 to 2016 for SAVR, TAVR, and disease symptoms (congestive heart failure, unstable angina, non-ST-elevation myocardial infarction, syncope). Patients not undergoing SAVR or TAVR were classified as receiving MT. Beginning with the index admission, we estimated inpatient costs, days, and admissions over 6 months. RESULTS: Among 190 563 patients with aortic valve disease, the average aggregate 6-month inpatient costs were $59 743 for SAVR, $64 395 for TAVR, and $23 460 for MT. Mean index admission was longer for SAVR (10.0 days) than for TAVR (7.0 day) or MT (5.3 days), but the average number of unplanned readmission inpatient days was 2.0 for SAVR, 3.0 for TAVR, and 4.3 for MT; the average number of total admissions was 1.3 for SAVR, 1.5 for TAVR, and 1.7 for MT (P<0.01 for all). TAVR index admission costs decreased over time to become similar to SAVR costs by 2016. CONCLUSIONS: Aggregate costs were higher for TAVR than SAVR and were significantly more expensive than MT alone. However, TAVR costs decreased over time while SAVR and MT costs remained unchanged.

Endovascular Versus Surgical Revascularization for Acute Limb Ischemia: A Propensity-Score Matched Analysis.

BACKGROUND: The optimal revascularization strategy for acute limb ischemia (ALI) remains unclear, and contemporary comparative effectiveness data on endovascular versus surgical revascularization are lacking. METHODS: We used the 2010 to 2014 National Inpatient Sample databases to identify hospitalizations with a primary diagnosis of ALI. Patients were propensity-score matched on the likelihood of undergoing endovascular versus surgical revascularization using a logistic regression model. The primary outcome was in-hospital mortality. Secondary outcomes included myocardial infarction, stroke, composite of death/myocardial infarction/stroke, any amputation, fasciotomy, acute kidney injury, major bleeding, transfusion, vascular complications, length of stay, and hospital costs. RESULTS: Of 10 484 (weighted national estimate=51 914) hospitalizations for ALI, endovascular revascularization was performed in 5008 (47.8%) and surgical revascularization in 5476 (52.2%). In the propensity-score matched cohort (n=7746; 3873 per group), patients who underwent endovascular revascularization had significantly lower in-hospital mortality (2.8% versus 4.0%; P=0.002), myocardial infarction (1.9% versus 2.7%; P=0.022), composite of death/myocardial infarction/stroke (5.2% versus 7.5%; P<0.001), acute kidney injury (10.5% versus 11.9%; P=0.043), fasciotomy (1.9% versus 8.9%; P<0.001), major bleeding (16.7% versus 21.0%; P<0.001), and transfusion (10.3% versus 18.5%; P<0.001), but higher vascular complications (1.4% versus 0.7%; P=0.002), compared with those undergoing surgical revascularization. Rates of any amputation were similar between the 2 groups (4.7% versus 5.1%; P=0.43). Median length of stay was shorter and hospital costs higher with endovascular versus surgical revascularization. CONCLUSIONS: In patients with ALI, endovascular revascularization was associated with better in-hospital clinical outcomes compared with surgical revascularization. Contemporary randomized controlled trials are needed to determine the optimal revascularization strategy for ALI.

Perfusion Assessment in Critical Limb Ischemia: Principles for Understanding and the Development of Evidence and Evaluation of Devices: A Scientific Statement From the American Heart Association.

There are >12 million patients with peripheral artery disease in the United States. The most severe form of peripheral artery disease is critical limb ischemia (CLI). The diagnosis and management of CLI is often challenging. Ethnic differences in comorbidities and presentation of CLI exist. Compared with white patients, black and Hispanic patients have higher prevalence rates of diabetes mellitus and chronic renal disease and are more likely to present with gangrene, whereas white patients are more likely to present with ulcers and rest pain. A thorough evaluation of limb perfusion is important in the diagnosis of CLI because it can not only enable timely diagnosis but also reduce unnecessary invasive procedures in patients with adequate blood flow or among those with other causes for ulcers, including venous, neuropathic, or pressure changes. This scientific statement discusses the current tests and technologies for noninvasive assessment of limb perfusion, including the ankle-brachial index, toe-brachial index, and other perfusion technologies. In addition, limitations of the current technologies along with opportunities for improvement, research, and reducing disparities in health care for patients with CLI are discussed.

Ankle-brachial index in patients with intermittent claudication is a poor indicator of patient-centered and clinician-based evaluations of functional status.

BACKGROUND: The association between the severity of ankle-brachial index (ABI), a traditional measure of the severity of peripheral artery disease (PAD), and patients' perceptions of their health status is poorly characterized. In Patient-Centered Outcomes Related to Treatment Practices in Peripheral Artery Disease: Investigating Trajectories (PORTRAIT), a study of patients with intermittent claudication (IC), we studied the correlation of ABI values and Rutherford symptom classification with PAD-specific health status as measured by the Peripheral Artery Questionnaire (PAQ). METHODS: Among 1251 patients with new onset or exacerbation of IC enrolled at 16 sites in the United States, Netherlands, and Australia, ABI values were categorized as mild (>0.80), moderate (0.40-0.79), and severe (<0.40). Spearman rank correlation coefficients were calculated between raw ABI values and PAQ scores and between the Rutherford classification and PAQ scores. RESULTS: Mean ABI was 0.67 (standard deviation, 0.19); 24.3% had mild, 67.6% moderate, and 8.1% severe PAD. According to the Rutherford classification, 22.7% were stage 1 (mild claudication), 49.5% stage 2 (moderate claudication), and 27.8% stage 3 (severe claudication). Correlations (95% confidence interval) were found between ABI and the PAQ summary score (r = 0.09 [0.04-0.15]) and the PAQ physical limitations score (r = 0.14 [0.09-0.20]); no correlations were found between ABI and the PAQ quality of life score (r = 0.03 [-0.02 to 0.09]) and the PAQ symptoms score (r = 0.04 [-0.01 to 0.10]). With the correlations between ABI and PAQ scores, ABI explained only 0.1% to 2.1% of the variation in PAQ scores. Rutherford classification had stronger but still modest associations with PAQ scores (PAQ summary, r = -0.27 [-0.21 to -0.32]; PAQ quality of life, r = -0.21 [-0.16 to -0.27]; PAQ symptoms, r = -0.18 [-0.13 to -0.23]; PAQ physical limitations, r = -0.27 [-0.22 to -0.32]); Rutherford class explained 3.2% to 7.3% of the variation in PAQ scores. CONCLUSIONS: In a large, international cohort of patients with IC, patient-centered health status assessments are weakly associated with physicians' or hemodynamic assessments. To best measure the impact of PAD on patients' symptoms, functional capacity, and quality of life, direct assessment from patients is needed, rather than relying on physiologic or clinician-assigned assessments.

Etiologies and predictors of 30-day readmissions in patients undergoing percutaneous mechanical circulatory support-assisted percutaneous coronary intervention in the United States: Insights from the Nationwide Readmissions Database.

BACKGROUND: Patients undergoing percutaneous mechanical circulatory support (pMCS)-assisted percutaneous coronary intervention (PCI) represent a high-risk group vulnerable to complications and readmissions. HYPOTHESIS: Thirty-day readmissions after pMCS-assisted PCI are common among patients with comorbidities and account for a significant amount of healthcare spending. METHODS: Patients undergoing PCI and pMCS (Impella, TandemHeart, or intra-aortic balloon pump) for any indication between January 1, 2012, and November 30, 2014, were selected from the Nationwide Readmissions Database. Patients were identified using appropriate ICD-9-CM codes. Clinical risk factors and complications were analyzed for association with 30-day readmission. RESULTS: Our analysis included 29 247 patients, of which 4535 (15.5%) were readmitted within 30 days. On multivariate analysis, age ≥ 65 years, female sex, hypertension, diabetes, chronic lung disease, heart failure, prior implantable cardioverter-defibrillator, liver disease, end-stage renal disease, and length of stay ≥5 days during index hospitalization were independent predictors of 30-day readmission. Cardiac etiologies accounted for ~60% of readmissions, of which systolic or diastolic heart failure (22%), stable coronary artery disease (11.1%), acute coronary syndromes (8.9%), and nonspecific chest pain (4.0%) were the most common causes. In noncardiac causes, sepsis/septic shock (4.6%), hypotension/syncope (3.2%), gastrointestinal bleed (3.1%), and acute kidney injury (2.6%) were among the most common causes of 30-day readmissions. Mean length of stay and cost of readmissions was 4 days and $16 191, respectively. CONCLUSIONS: Thirty-day readmissions after pMCS-assisted PCI are common and are predominantly associated with increased burden of comorbidities. Reducing readmissions for common cardiac etiologies could save substantial healthcare costs.

Public Health Impact of the Centers for Medicare and Medicaid Services Decision on Pass-Through Add-On Payments for Drug-Coated Balloons: A Call to Action.

On Wednesday, November 1, 2017, the Centers for Medicare and Medicaid Services (CMS) made a public decision to end the transitional pass-through add-on payment for drug-coated balloons beginning January 1, 2018, without creating a new ambulatory payment classification rate for these devices. In this Viewpoint, the authors highlight the disconnect between the CMS's decision not to create a new ambulatory payment classification category for drug-coated balloons despite demonstrated clinical superiority. The authors believe this decision is more in line with a rigid fee-for-service payment system than a value-based system that encourages quality over quantity, and disadvantages both the elderly and the poor. They call on all who advocate for patients with peripheral artery disease to action, encouraging their engagement on CMS decisions regarding payment.

Ventricular septal rupture complicating acute myocardial infarction: Incidence, treatment, and outcomes among medicare beneficiaries 1999-2014.

OBJECTIVES: The present study was designed to assess whether the incidence and outcomes of VSR-AMI have changed in the era of timely primary PCI. BACKGROUND: Ventricular septal rupture (VSR) is a rare but frequently fatal complication of acute myocardial infarction (AMI). METHODS: We conducted a retrospective cohort study of all Medicare fee-for-service beneficiaries from 1999 to 2014 to examine trends in the incidence, surgical and percutaneous repair, and 30-day and 1-year mortality of VSR-AMI. RESULTS: The annual incidence of VSR-AMI hospitalization declined by 41.6% from 197 patients per 100,000 AMIs in 1999 to 115 patients per 100,000 AMIs in 2014 (P < 0.001). The 30-day VSR-AMI repair rate decreased from 49.9% in 1999 to 33.3% in 2014 (P < 0.001). In 2014, 82.9% of repairs were performed surgically and 17.1% percutaneously. VSR-AMI mortality rates were high (60.2% at 30 days; 68.5% at 1 year) and changed minimally over the study period with adjusted 30-day mortality per year Odds Ratio (OR) 0.99 (95% confidence interval [CI] 0.98-1.01) and adjusted 1-year mortality per year OR 0.98 (95% CI 0.97-1.00). Across the 16 years of data, unadjusted mortality rates were lower in patients undergoing repair than in unrepaired patients at 30 days (mean 51.7% and 65.7%, P ≤ 0.01) and 1 year (mean 62.0% and 72.8%, P < 0.01). CONCLUSIONS: In the era of increased timely primary PCI, the incidence of VSR-AMI hospitalization declined but its associated mortality rate remained high. Rates of VSR repair decreased from 1999 to 2014 despite increased use of percutaneous repair.

PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories): Overview of Design and Rationale of an International Prospective Peripheral Arterial Disease Study.

BACKGROUND: Health status outcomes, including symptoms, functional status, and quality of life, are critically important outcomes from patients' perspectives. The PORTRAIT study (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) was designed to prospectively define health status outcomes and examine associations between patients' characteristics and care to these outcomes among those presenting with new-onset or worsened claudication. METHODS AND RESULTS: PORTRAIT screened 3637 patients with an abnormal ankle-brachial index and new, or worsened, claudication symptoms from 16 peripheral arterial disease (PAD) specialty clinics in the United States, the Netherlands, and Australia between June 2, 2011, and December 3, 2015. Of the 1608 eligible patients, 1275 (79%) were enrolled. Before treatment, patients were interviewed to obtain their demographics, PAD symptoms and health status, psychosocial characteristics, preferences for shared decision-making, socioeconomic, and cardiovascular risk factors. Patients' medical history, comorbidities, and PAD diagnostic information were abstracted from patients' medical records. Serial information about patients' health status, psychosocial, and lifestyle factors was collected at 3, 6, and 12 months by a core laboratory. Follow-up rates ranged from 84.2% to 91%. Clinical follow-up for PAD-related hospitalizations and major cardiovascular events is ongoing. CONCLUSIONS: PORTRAIT systematically collected serial PAD-specific health status data as a foundation for risk stratification, comparative effectiveness studies, and clinicians' adherence to quality-based performance measures. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01419080.

Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.

OBJECTIVE: The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible. METHODS: Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. RESULTS: The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. CONCLUSIONS: Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.

Association between health status and sociodemographic, clinical and treatment disparities in the Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) registry.

Patients with peripheral artery disease (PAD) and intermittent claudication (IC) have impaired functional status and quality of life. However, little is known about which factors are associated with poorer health status at the time of initial presentation for PAD specialty care. Characterization of such features might provide insight into disparities that impact health status in this population. A total of 1258 patients from the United States, the Netherlands and Australia with new or worsened IC were enrolled at their first PAD specialty care visit between June 2011 and December 2015. The mean Peripheral Artery Questionnaire (PAQ) Summary Score (range 0-100), a disease-specific health status measure, was 49.2 ± 21.9. Hierarchical, multivariable linear regression was used to relate patient characteristics to baseline PAQ. Patient characteristics independently associated with poorer health status were age ( p < 0.001), female sex ( p < 0.001), not being married ( p = 0.02), economic burden (moderate/severe vs none, moderate/severe vs some; p = 0.03), difficulty getting care (moderate/severe vs none, moderate/severe vs some; p < 0.001), chronic lung disease ( p = 0.02), back pain ( p < 0.001), bilateral vs unilateral PAD ( p = 0.02), intermittent claudication severity (moderate vs mild, severe vs mild, p < 0.001), and lack of prior participation in an exercise program ( p = 0.005). Disparities in both vascular and non-vascular factors were associated with patients' health status at the time of presentation and should be addressed by all who care for patients with vascular disease.

Contemporary Sex-Based Differences by Age in Presenting Characteristics, Use of an Early Invasive Strategy, and Inhospital Mortality in Patients With Non-ST-Segment-Elevation Myocardial Infarction in the United States.

BACKGROUND: Prior studies have reported higher inhospital mortality in women versus men with non-ST-segment-elevation myocardial infarction. Whether this is because of worse baseline risk profile compared with men or sex-based disparities in treatment is not completely understood. METHODS AND RESULTS: We queried the 2003 to 2014 National Inpatient Sample databases to identify all hospitalizations in patients aged ≥18 years with the principal diagnosis of non-ST-segment-elevation myocardial infarction. Complex samples multivariable logistic regression models were used to examine sex differences in use of an early invasive strategy and inhospital mortality. Of 4 765 739 patients with non-ST-segment-elevation myocardial infarction, 2 026 285 (42.5%) were women. Women were on average 6 years older than men and had a higher comorbidity burden. Women were less likely to be treated with an early invasive strategy (29.4% versus 39.2%; adjusted odds ratio, 0.92; 95% confidence interval, 0.91-0.94). Women had higher crude inhospital mortality than men (4.7% versus 3.9%; unadjusted odds ratio, 1.22; 95% confidence interval, 1.20-1.25). After adjustment for age (adjusted odds ratio, 0.96; 95% confidence interval, 0.94-0.98) and additionally for comorbidities, other demographics, and hospital characteristics, women had 10% lower odds of inhospital mortality (adjusted odds ratio, 0.90; 95% confidence interval, 0.89-0.92). Further adjustment for differences in the use of an early invasive strategy did not change the association between female sex and lower risk-adjusted inhospital mortality. CONCLUSIONS: Although women were less likely to be treated with an early invasive strategy compared with men, the lower use of an early invasive strategy was not responsible for the higher crude inhospital mortality in women, which could be entirely explained by older age and higher comorbidity burden.

Registry Assessment of Peripheral Interventional Devices (RAPID)　- Registry Assessment of Peripheral Interventional Devices Core Data Elements.

BACKGROUND: The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible.Methods and Results:Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. CONCLUSIONS: Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.

Endovascular Versus Surgical Revascularization for Chronic Mesenteric Ischemia: Insights From the National Inpatient Sample Database.

OBJECTIVES: This study sought to compare in-hospital major adverse cardiac and cerebrovascular events (MACCE) following endovascular therapy with open surgery for chronic mesenteric ischemia (CMI). BACKGROUND: There are limited contemporary data on in-hospital cardiovascular outcomes among patients with CMI undergoing revascularization via endovascular therapy versus open surgery in the United States. METHODS: Patients with CMI undergoing endovascular or surgical (mesenteric bypass or endarterectomy) revascularization between 2007 and 2014 were identified from the National Inpatient Sample. Weighted national estimates were obtained. Primary and secondary endpoints were MACCE (death, myocardial infarction, stroke, cardiac post-operative complications) and composite in-hospital complications (MACCE + post-operative peripheral vascular complications, gastrointestinal hemorrhage, major bleeding, and bowel resection), respectively. Propensity score matching was used to obtain a balanced cohort of 880 unweighted patients in each group. RESULTS: Of 4,150 patients with CMI, 3,206 (77.2%) underwent endovascular therapy and 944 (22.8%) underwent surgery (weighted national estimates of 15,850 and 4,687, respectively). In the propensity-matched cohort, MACCE and composite in-hospital complications occurred significantly less often after endovascular therapy than surgery (8.6% vs. 15.9%; p < 0.001; and 15.3% vs. 20.3%; p < 0.006). Endovascular therapy was also associated with lower median hospital costs ($20,807.00 [interquartile range: $13,640.20 to $32.754.50] vs. $31,137.00 [interquartile range: $21,680.40 to $52,152.20]; p < 0.001, respectively) and shorter length of stay (5 [interquartile range: 2 to 10] vs. 10 [interquartile range: 7 to 17] days, respectively; p < 0.001) compared with open surgery. CONCLUSIONS: In a large, retrospective analysis of patients with CMI, endovascular therapy remained the dominant revascularization modality, and was associated with lower rates of MACCE, composite in-hospital complications, lower costs, and shorter length of stay compared with surgery.

Association Between Hospital Volume and 30-Day Readmissions Following Transcatheter Aortic Valve Replacement.

Importance: With the approval of transcatheter aortic valve replacement (TAVR) for patients with severe symptomatic aortic stenosis at intermediate surgical risk, TAVR volume is projected to increase exponentially in the United States. The 30-day readmission rate for TAVR was recently reported at 17.9%. The association between institutional TAVR volume and the 30-day readmission metric has not been examined. Objective: To assess the association between hospital TAVR volume and 30-day readmission. Design, Setting, and Participants: In this observational study, we used the 2014 Nationwide Readmissions Database to identify hospitals with established TAVR programs (performing at least 5 TAVRs in the first quarter of 2014). Based on annual TAVR volume, hospitals were classified as low (<50), medium (≥50 to <100), and high (≥100) volume. Rates, causes, and costs of 30-day readmissions were compared between low-, medium-, and high-volume hospitals. Data were analyzed from November to December 2016. Exposure: Transcatheter aortic valve replacement. Main Outcomes and Measures: Thirty-day readmissions. Results: Of 129 hospitals included in this study, 20 (15.5%) were categorized as low volume, 47 (36.4%) as medium volume, and 62 (48.1%) as high volume. Of 16 252 index TAVR procedures, 663 (4.1%), 3067 (18.9%), and 12 522 (77.0%) were performed at low-, medium-, and high-volume hospitals, respectively. Thirty-day readmission rates were significantly lower in high-volume compared with medium-volume (adjusted odds ratio, 0.76; 95% CI, 0.68-0.85; P < .001) and low-volume (adjusted odds ratio, 0.75; 95% CI, 0.60-0.92; P = .007) hospitals. Noncardiac readmissions were more common in low-volume hospitals (65.6% vs 60.6% in high-volume hospitals), whereas cardiac readmissions were more common in high-volume hospitals (39.4% vs 34.4% in low-volume hospitals). There were no significant differences in length of stay and costs per readmission among the 3 groups (mean [SD], 5.5 [5.0] days vs 5.9 [7.5] days vs 6.0 [5.8] days; P = .74, and $13 886 [18 333] vs $14 135 [17 939] vs $13 432 [15 725]; P = .63, respectively). Conclusions and Relevance: We report for the first time, to our knowledge, an inverse association between hospital TAVR volume and 30-day readmissions. Lower readmission at higher-volume hospitals was associated with significantly lower cost to the health care system.

Sex differences in disease-specific health status measures in patients with symptomatic peripheral artery disease: Data from the PORTRAIT study.

Peripheral artery disease (PAD) is associated with poor health status (symptoms, functioning, quality of life (QOL)). Whether sex differences exist in PAD-specific health status is unknown. In patients presenting to a specialty clinic with new-onset or recent exacerbation of PAD, we examined sex differences as assessed by the Peripheral Artery Questionnaire (PAQ). The Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) study is a multicenter, international prospective study of patients with new or worsening PAD symptoms. Baseline characteristics and mean PAQ scores were compared among women ( n=481) and men ( n=793) before they underwent treatment. The independent association of sex with health status was assessed with multivariable linear regression. As compared with men, women were less often Caucasian, married and employed, and more often lacking health insurance, living alone (36.2% vs 23.6%, p<0.001), had depression and avoided care due to cost (17.0% vs 12.3%, p=0.018). Women and men were of a similar age and education level, and had similar ankle-brachial index (ABI) values (0.7 ± 0.2 in both groups, p=0.052). Female sex was independently associated with lower PAQ scores on all domains (physical functioning adjusted mean difference of -8.40, p<0.001; social functioning adjusted mean difference of -6.8, p<0.001; QOL adjusted mean difference of -6.7, p<0.001), although no differences were observed in treatment satisfaction (adjusted mean difference -0.20, p=0.904). Despite similar ABIs, women presenting with symptoms of PAD had poorer PAD-specific functioning as compared with men, impacting all major health status domains, independent of socio-economic and clinical characteristics.

Contrast-induced nephropathy in patients undergoing endovascular peripheral vascular intervention: Incidence, risk factors, and outcomes as observed in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

BACKGROUND: The incidence, risk factors, and outcomes associated with Contrast-induced nephropathy (CIN) after Percutaneous Vascular Intervention (PVI) in contemporary medical practice are largely unknown. METHODS: A total of 13 126 patients undergoing PVI were included in the analysis. CIN was defined as an increase in serum creatinine from pre-PVI baseline to post-PVI peak Cr of ≥0.5 mg/dL. RESULTS: CIN occurred in 3% (400 patients) of the cohort, and 26 patients (6.5%) required dialysis. Independent predictors of CIN were high and low body weight, diabetes, heart failure, anemia, baseline renal dysfunction, critical limb ischemia, and a higher acuity of the PVI procedure and a contrast dose that was greater than three times the calculated creatinine clearance (CCC) (adjusted OR 1.4, 95% CI: 1.1-1.8, P = 0.003). CIN was strongly associated with adverse outcome including in-hospital death (adjusted OR 18.1, CI 10.7-30.6, P < 0.001), myocardial infarction (adjusted OR 16.2, CI 8.9-29.5, P < 0.001), transient ischemic attack/stroke (adjusted OR 5.5, CI 3.2-14.9, P = 0.001), vascular access complications (adjusted OR 3.4, CI 2.3-5, P < 0.001), and transfusion (adjusted OR 7, CI 5.4-9, P < 0.001). Hospital stay was longer in patients who developed CIN versus those who did not. CONCLUSIONS: CIN is not an uncommon complication associated with PVI, can be reliably predicted from pre-procedural variables, including a contrast dose of greater than three times the CCC and is strongly associated with the risk of in-hospital death, MI, stroke, transfusion, and increased hospital length of stay.