Thirty-Day Readmission Rate and Healthcare Economic Effects of Patients With Transcatheter Aortic Valve Replacement and Coexisting Chronic Congestive Heart Failure.

Transcatheter aortic valve replacement (TAVR) procedures have increased since adoption in 2010. Readmission for TAVR patients with underlying chronic congestive heart failure (cCHF) remains challenging. Therefore, we sought to determine the 30-day readmission rate (30-DRr) of patients who undergo TAVR & co-existing cCHF and its impact on mortality & healthcare utilization in the United States. We performed a retrospective study using the national readmission database year 2017 and 2018. The patients studied were discharged with TAVR as a principal diagnosis and underlying cCHF as a secondary diagnosis according to ICD-10 codes. The primary outcome was a 30-day readmission rate and mortality, while secondary outcomes were the most common diagnoses for readmission, and resource utilization. A total of 76,892 index hospitalization for TAVR with coexisting cCHF: mean age was 79.7 years [SD: ± 2], and 54.5% of patients were males. In-hospital mortality rate for index admission was 1.63%. The 30-DRr was 9.5%. Among the group of readmitted patients, in-hospital mortality rate was 3.13%. Readmission mortality showed a statistically significant increase compared to index mortality (3.13% vs 1.63%, adjusted P ≤ 0.001, aOR: 2.1, 95% CI: 1.6-2.9). The total healthcare in-hospital economic spending was $94.4 million, and total patient charge of $412 million. Approximately 1 in 10 patients who underwent TAVR with underlying cCHF had 30-DRr, with subsequent readmissions associated with increased healthcare spending. Readmission mortality showed a statistically significant increase when compared to index mortality. TAVR patients with cCHF are a vulnerable subset requiring additional outpatient care.

The shifting care and outcomes for patients with endangered limbs - Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale.

BACKGROUND: Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (>20% at 1 year). Little is known about the processes of care, patients' preferences, or outcomes, as seen from patients' perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI. METHODS: This 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers. RESULTS: A total of 70 patients have been enrolled. The mean age was 68.4 ± 11.3 years, 31.4% were female, and 20.0% were African American. CONCLUSIONS: SCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes.ClinicalTrials.gov identifier (NCT Number): NCT04710563 https://clinicaltrials.gov/ct2/show/NCT04710563.

Safety, Efficacy, and Cost-Effectiveness of Same-Day Discharge for Left Atrial Appendage Occlusion.

BACKGROUND: Percutaneous left atrial appendage occlusion (LAAO) with the Watchman device is FDA approved for stroke prevention in patients with nonvalvular atrial fibrillation who have an appropriate indication. During the COVID-19 pandemic, a same-day discharge protocol (SDDP) was employed to improve resource utilization, relieve hospital occupation, and reduce the possible risk of in-hospital virus transmission. OBJECTIVES: We sought to analyze the safety, feasibility, and cost effectiveness for SDDP in patients receiving LAAO. METHODS: A prospective analysis of 142 consecutive patients, 119 treated prior to SDDP and 23 who underwent SDDP following LAAO with cardiac computed tomography angiography (CTA)-guided pre-procedural planning and intracardiac echocardiogram (ICE). Procedures were performed in a single, large academic hospital in the United States. In-hospital and 45-day procedural success, adverse events, length of procedure, and length-of-stay were evaluated. RESULTS: Baseline patient characteristics including mean CHA2DS2VASc scores and mean HAS-BLED scores were similar in both groups. All procedures were successful. There was no significant difference in rates of procedural complications or in-hospital adverse events. The mean procedure time in the SDDP group was 11 minutes longer than in the conventional group (62.1 ± 5.9 vs 51.1 ± 21; P=.01). Outcomes at 45-day follow-up were similar. SDDP was associated with a reduced length of stay compared with conventional strategy and a 15% reduction in total costs. CONCLUSIONS: Same-day discharge strategy for LAAO appears safe, feasible and could become the new standard approach for LAAO. A protocol including CTA pre-procedural planning, ICE-guided deployment and conscious sedation reduces hospital occupation and lowers costs.

Association of Frailty With Treatment Selection and Long-Term Outcomes Among Patients With Chronic Limb-Threatening Ischemia.

Background The optimal treatment strategy for patients with chronic limb-threatening ischemia (CLTI) is often unclear. Frailty has emerged as an important factor that can identify patients at greater risk of poor outcomes and guide treatment selection, but few studies have explored its utility among the CLTI population. We examine the association of a health record-based frailty measure with treatment choice and long-term outcomes among patients hospitalized with CLTI. Methods and Results We included patients aged >65 years hospitalized with CLTI in the Medicare Provider Analysis and Review data set between October 1, 2009 and September 30, 2015. The primary exposure was frailty, defined by the Claims-based Frailty Indicator. Baseline frailty status and revascularization choice were examined using logistic regression. Cox proportional hazards regression was used to determine the association between frailty and death or amputation, stratifying by treatment strategy. Of 85 060 patients, 35 484 (42%) were classified as frail. Frail patients had lower likelihood of revascularization (adjusted odds ratio [OR], 0.78; 95% CI, 0.75‒0.82). Among those revascularized, frailty was associated with lower likelihood of surgical versus endovascular treatment (adjusted OR, 0.76; CI, 0.72‒0.81). Frail patients experienced increased risk of amputation or death, regardless of revascularization status (revascularized: adjusted hazard ratio [HR], 1.34; CI, 1.30‒1.38; non-revascularized: adjusted HR, 1.22; CI, 1.17‒1.27). Among those revascularized, frailty was independently associated with amputation or death irrespective of revascularization strategy (surgical: adjusted HR, 1.36; CI, 1.31‒1.42; endovascular: aHR, 1.29; CI, 1.243‒1.35). Conclusions Among patients hospitalized with CLTI, frailty is an important independent predictor of revascularization strategy and longitudinal adverse outcomes.

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.

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.

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.

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.

Hemodynamic Assessment Before and After Endovascular Therapy for Critical Limb Ischemia and Association With Clinical Outcomes.

OBJECTIVES: This study sought to determine the relationship between change in ankle-brachial index (ABI) and toe-brachial index (TBI) and outcomes following revascularization of critical limb ischemia (CLI). BACKGROUND: An increase in ABI of 0.15 after revascularization for peripheral artery disease with claudication is considered significant. However, the utility of using change in ABI or TBI to predict outcomes in patients with CLI is unproven. METHODS: This was an observational study of 218 patients with Rutherford class V or VI CLI that underwent endovascular therapy. Receiver-operating characteristic curve analysis determined cutpoints in post-procedure ABI and TBI, as well as change in these values for endpoints of wound healing, major adverse limb events (MALE), and repeat revascularization. RESULTS: After multivariable Cox proportional hazards analysis adjusting for age, diabetes, glomerular filtration rate, smoking, Rutherford class, and baseline ABI or TBI, neither static post-procedure ABI nor post-procedure TBI were associated with wound healing (hazard ratio [HR]: 1.21; 95% confidence interval [CI]: 0.77 to 1.89; p = 0.40; HR: 1.49; 95% CI: 0.98 to 2.27; p = 0.065, respectively). However, change in ABI ≥0.23 was independently associated with wound healing (HR: 1.87; 95% CI: 1.12 to 3.15; p = 0.018) and less repeat revascularization (HR: 0.40; 95% CI: 0.19 to 0.84; p = 0.015), but not MALE. Increase in TBI ≥0.21 was independently associated with wound healing (HR: 1.63; 95% CI: 1.02 to 2.59; p = 0.039), and reduced MALE (HR: 0.27; 95% CI: 0.09 to 0.77; p = 0.014), but not repeat revascularization. CONCLUSIONS: A change in ABI and TBI from pre-procedural values provides prognostic value in determining which patients may have wound healing and reduced MALE.

Percutaneous Therapies for Peripheral Artery Disease.

Percutaneous therapies for peripheral artery disease continue to evolve with new techniques and devices. Although guidelines-recommended therapies have impacted cardiovascular morbidity and mortality, endovascular interventions have been shown to reduce limb pain, improve quality of life, and prolong walking distance for those with claudication and to reduce amputation rates among those with critical limb ischemia. Novel devices such as drug-eluting stents and drug-coated balloons have improved patency for moderate-length lesions, whereas others allow treatment of heavily calcified and tortuous segments. New adjunctive devices to cross lesions and reduce or modify associated plaque have also been developed, although level 1 data regarding their efficacy are sparse. There has also been a better mechanistic understanding of lower extremity endovascular treatment using tools such as intravascular ultrasound. This information has highlighted the need for better stent size selection for the femoropopliteal arterial segments and larger balloon diameters for the tibial arteries. Moreover, a wound perfusion approach with direct in-line flow, the so-called angiosome approach, and reconstruction of the pedal loop have been advocated for improved wound healing. Technical advances such as the tibiopedal access and reentry methods have allowed crossing of lesions that were considered no option for the endovascular approach in the past. Collectively, there has been increased awareness, interest, and commitment by various specialty societies and organizations to advance the treatment of peripheral artery disease and critical limb ischemia. This is also evident by the recent coalition of 7 professional societies and organizations that represented >150 000 allied health professionals and millions of patients with peripheral artery disease at the 2015 Centers for Medicaid and Medicare Services Medicare Evidence Development and Coverage Analysis Committee meeting. The percutaneous therapies for peripheral artery disease continue to evolve with longer follow-up with randomized data and larger prospective registries. In the future, it is hopeful that we will treat the lower extremity arteries according to segments, taking into account plaque morphology, luminal versus subintimal crossing, location, and stenotic versus occlusive disease. Until then, we must identify the most cost-effective, efficacious, and safe treatment for each patient. The goal of this article is to aid the practicing vascular specialist consider the optimal choices for the management of patients with vascular disease.

Clinical utility of cerebral angiography in the preoperative assessment of endocarditis.

Cerebral angiography is an invasive procedure utilized without supporting guidelines in preoperative evaluations of infective endocarditis (IE). It is used to identify mycotic intracranial aneurysm, which is suspected to increase the risk of intracranial bleeding during cardiac surgery. Our objectives were to: (1) assess the utility of cerebral angiography by determining which subset of IE patients benefit from its performance; and (2) identify clinical and noninvasive screening tests that can preclude the need for invasive cerebral angiography. Retrospective analysis was performed of all patients treated surgically for IE from 7/2007 to 1/2012 and discharged with medical treatment for IE from 7/2007 to 7/2009 presenting to a large academic center. Of the 151 patients who underwent cerebral angiography, mycotic aneurysm was identified in seven (prevalence=4.6%; 95% CI 2.3-9.3%). Five had viridans group streptococci as the causative IE microorganism (p=0.0017). Noninvasive imaging and particularly absence of intracranial bleed on magnetic resonance imaging conveys a negative predictive value (NPV) of 0.977 (95% CI 0.879-0.996). Absence of a focal neurologic deficit or altered mental status convey a NPV of 0.990 (95% CI 0.945-0.998) and 0.944 (95% CI 0.883-0.974), respectively. Clinical suspicion for mycotic aneurysm and thus utilization of cerebral angiography is likely necessary only in the setting of acute neurologic deficits and when noninvasive imaging demonstrates acute intracranial bleed. A novel association between viridans group streptococci and intracranial mycotic aneurysm is demonstrated.

Presence of external carotid artery plaque independently predicts mortality in patients without internal carotid artery atherosclerosis.

BACKGROUND: The presence of plaque in the external carotid artery (ECA) detected on carotid duplex ultrasound (CDU) is of unknown clinical significance and may not be reported in routine clinical practice. We hypothesize that ECA plaque in the absence of plaque in the other cervical vessels is a risk factor for increased all-cause mortality. OBJECTIVES: To determine the significance of ECA plaque on all-cause mortality in the absence of internal carotid artery (ICA) or common carotid artery (CCA) plaque. METHODS: We queried the Non-Invasive Vascular Laboratory database for all CDUs performed between 1 January 2005 and 31 December 2005. All images were reviewed for the presence of plaque. Studies were included if plaque was absent in both the CCA and the ICA. Chart review was performed to obtain demographic and clinical information. All-cause mortality was determined using the Social Security Death Index. RESULTS: A total of 500 patient studies met the inclusion criteria; 64 patients (12.8%) had plaque in one or both ECAs. There was no significant difference in age (mean 58.1 ± 14.8 years), race (82.5% white), or sex (64.4% male) between those with and without ECA plaque. There was a significant difference in all-cause mortality between patients with and without isolated ECA plaque after adjustment for age, sex, low-density lipoprotein cholesterol, smoking, hypertension, body mass index, and surgery within 30 days of CDU (adjusted hazard ratio 2.60, 95% CI 1.46-4.66, p<0.001). CONCLUSIONS: The presence of plaque isolated to the ECA is an independent predictor of all-cause mortality and may impart important prognostic information for patients referred for CDU.

Acute and critical limb ischemia: when time is limb.

Acute and critical limb ischemia post significant rates of morbidity and death, and need to be promptly recognized and treated to avoid amputation. Perfusion should be thoroughly assessed using multiple methods, and patients should be considered for revascularization (angioplasty or bypass surgery) to restore blood perfusion. Underlying conditions that need to be assessed and treated include cardiovascular disease, diabetes, and infection.

A direct comparison of early and late outcomes with three approaches to carotid revascularization and open heart surgery.

OBJECTIVES: The aim of this study was a comparison of risk-adjusted outcomes of 3 approaches to carotid revascularization in the open heart surgery (OHS) population. BACKGROUND: Without randomized clinical trials, the best approach to managing coexisting severe carotid and coronary disease remains uncertain. Staged carotid endarterectomy (CEA) followed by OHS or combined CEA and OHS are commonly used. A recent alternative is carotid artery stenting (CAS). METHODS: From 1997 to 2009, 350 patients underwent carotid revascularization within 90 days before OHS at a tertiary center: 45 staged CEA-OHS, 195 combined CEA-OHS, and 110 staged CAS-OHS. The primary composite endpoint was all-cause death, stroke, and myocardial infarction (MI). Staged CAS-OHS patients had higher prevalence of previous stroke (p = 0.03) and underwent more complex OHS. Therefore, the propensity score adjusted multiphase hazard function models with modulated renewal to account for staging, and competing risks were used. RESULTS: Using propensity analysis, staged CAS-OHS and combined CEA-OHS had similar early hazard phase composite outcomes, whereas staged CEA-OHS incurred the highest risk driven by interstage MI. Subsequently, staged CAS-OHS patients experienced significantly fewer late hazard phase events compared with both staged CEA-OHS (adjusted hazard ratio: 0.33; 95% confidence interval: 0.15 to 0.77; p = 0.01) and combined CEA-OHS (adjusted hazard ratio: 0.35; 95% confidence interval: 0.18 to 0.70; p = 0.003). CONCLUSIONS: Staged CAS-OHS and combined CEA-OHS are associated with a similar risk of death, stroke, or MI in the short term, with both being better than staged CEA-OHS. However, the outcomes significantly favor staged CAS-OHS after the first year.