Long-term Outcomes of Peripheral Artery Disease In Veterans: Analysis of the PEripheral ARtery Disease Long-term Survival Study (PEARLS).

Background: Contemporary research in peripheral artery disease (PAD) remains limited due to lack of a national registry and low accuracy of diagnosis codes to identify PAD patients in electronic health records. Methods & Results: Leveraging a novel natural language processing (NLP) system that identifies PAD with high accuracy using ankle brachial index (ABI) and toe-brachial index (TBI) values, we created a registry of 103,748 patients with new onset PAD patients in the Veterans Health Administration (VHA). Study endpoints include mortality, cardiovascular (hospitalization for acute myocardial infarction or stroke) and limb events (hospitalization for critical limb ischemia or major amputation) and were identified using VA and non-VA encounters. The mean age was 70.6 years; 97.3% were males, and 18.5% self-identified as Black race. The mean ABI value was 0.78 (SD: 0.26) and the mean TBI value was 0.51 (SD: 0.19). Nearly one-third (32.4%) patients were currently smoking and 35.4% formerly smoked. Prevalence of hypertension (86.6%), heart failure (22.7%), diabetes (54.8%), renal failure (23.6%), and chronic obstructive pulmonary disease (35.4%) was high. At 1-year, 9.4% of patients had died. The 1-year incidence of cardiovascular events was 5.6 per 100 patient-years and limb events was 4.5 per 100 patient-years. Conclusions: We have successfully launched a registry of >100,000 patients with a new diagnosis of PAD in the VHA, the largest integrated health system in the U.S. The ncidence of death and clinical events in our cohort is high. Ongoing studies will yield important insights regarding improving care and outcomes in this high-risk group.

Clinical Outcomes of Non-Stent-Based Interventions for Symptomatic Below-the-Knee Peripheral Artery Disease in the Excellence in Peripheral Artery Disease (XLPAD) Registry.

For endovascular treatment of below-the-knee (BTK) peripheral artery disease (PAD), independently adjudicated real-world outcomes comparing non-stent-based balloon angioplasty (percutaneous transluminal angioplasty) and adjunctive treatments with or without a concomitant ipsilateral femoropopliteal (FP) artery intervention are scarce. A total of 1,060 patients from the multicenter XLPAD registry who underwent non-stent-based BTK PAD intervention between 2006 and 2021 were included. The primary outcome was the 1-year incidence of major adverse limb events (MALEs), a composite of all-cause death, any amputation, or clinically driven repeat revascularization. A total of 566 patients underwent BTK and 494 BTK + FP interventions; 72% were men, with a mean age of 68.4 ± 10.9 years. Diabetes mellitus was more prevalent in the BTK-only group (76.5% vs 69%, p = 0.006). Mean Rutherford class was 4.2 ± 1.18; chronic limb-threatening ischemia was more frequent in the BTK group (55.3% vs 49%, p = 0.040). Moderate to severe calcification was more frequent in the BTK + FP group (21.2% vs 27.1%, p = 0.024), as was lesion length (110.6 ± 77.3 vs 135.4 ± 86.3 mm, p <0.001). Nearly 81% of lesions were treated with percutaneous transluminal angioplasty. Drug-coated balloon (1.6% vs 14%, p <0.001) and atherectomy (38% vs 58.5%, p <0.001) use was more frequent in the BTK + FP group. The rate of procedural success was higher in the BTK + FP group (86% vs 91%, p = 0.009), with amputation being the most common complication at 3.3% within 30 days after the procedure. The rates of 1-year MALE (21.2% vs 22.3%, p = 0.675) and mortality (4.6% vs 3.4%, p = 0.3) were similar between the BTK and BTK + FP groups. Nonstent treatment for BTK PAD with concomitant FP intervention leads to high procedural success and similar rates of 1-year MALE compared with isolated BTK intervention. Condensed Abstract: The vast majority of below-the-knee (BTK) peripheral artery disease (PAD) interventions are performed with balloon angioplasty. Presence of inflow femoropopliteal PAD in patients who undergo BTK interventions can affect the outcome of the procedure. This report explores immediate procedural success and major adverse limb events at 1 year after balloon angioplasty treatment for isolated BTK PAD and in patients who underwent an additional femoropopliteal PAD intervention.

SCAI Manual of Standard Operating Procedures for Performing Scientific Surveys.

The Society for Cardiovascular Angiography & Interventions (SCAI) endeavors to serve the interventional cardiology community, including both clinicians and patients. The SCAI Scientific Oversight Committee is charged with annually reviewing the scientific needs of the membership at large, including survey-based research of the practice patterns and perspectives of SCAI members and stakeholders. This document is intended as a reference by the survey proponents, document writing groups, external collaborators, SCAI representatives, peer reviewers, and anyone seeking information about the SCAI surveys program. The aims of this SCAI document are to: (1) provide a framework for members to develop survey requests that are relevant, feasible, and align with the Society's missions and goals; (2) promote transparency and clarity for the process of performing a survey through SCAI; (3) establish the criteria for evaluating survey requests and provide input on reliable and meaningful design, data collection, and best practices; and (4) facilitate collaboration and communication between the survey committee and members of SCAI to maximize the impact of the findings to the interventional community at large.

Five-Year Outcomes of Measured and Predicted Prosthesis-Patient Mismatch following Transcatheter Aortic Valve Implantation.

Data on the long-term outcomes of prosthesis patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) remain controversial. This study aimed to investigate the incidence and clinical outcomes of measured PPM (PPMM) and predicted PPM (PPMP) in patients who underwent TAVI. This is a retrospective analysis of 3,016 patients who underwent TAVI at a large health care system between 2012 and 2021. Effective orifice area indexed to body surface area (EOAi) was measured at discharge using the continuity equation. EOAi was predicted according to the published predictive tables for each model and size of the valve. Primary end point was 5-year survival rate. Mean age was 80 years, and 55.6% were male. The mean Society of Thoracic Surgeons risk score was 4.66%. 74.9% of patients received a balloon-expandable valve (BEV), and 25.1% received a self-expanding valve (SEV). The incidence of severe PPM was markedly lower when defined by predicted versus measured EOAi (0.8% vs 6.3%, p <0.001) and when assessed in SEV versus BEV (5.3% vs 6.6%, p = 0.02). Neither severe PPMp nor severe PPMM was associated with 5-year mortality (hazard ratio 1.26, 95% confidence interval 0.96 to 1.66, p = 0.095; hazard ratio 1.03, 95% confidence interval 0.42 to 2.49, p = 0.954, respectively), irrespective of the presence of high residual pressure gradient. Neither BEV nor SEV was associated with an increased 5-year mortality, irrespective of PPM definition or severity. In this large health care system analysis, neither severe PPMP nor severe PPMM was associated with 5-year all-cause mortality. There was no difference between BEV and SEV in terms of mortality, irrespective of the definition or severity of PPM.

Cardiac Computed Tomography Angiography in the Evaluation of Coronary Artery Disease: An Interventional Perspective.

Cardiac computed tomography angiography (CCTA) has become the gold standard for noninvasive anatomic assessment of the coronary arteries. With high positive predictive value and even higher negative predictive value, CCTA allows for rapid determination of the presence or absence of coronary plaque and triage of patients' need for further invasive evaluation and treatment. From an interventional cardiologist's perspective, CCTA (more so than stress testing) is helpful in determining the need for invasive therapy. In conjunction with functional assessments, the anatomic evaluation from CCTA mirrors the anatomical assessment of a coronary angiogram more than any other noninvasive assessment. This allows for catheter selection, percutaneous coronary intervention preplanning, as well as additional decision making before the patient has entered the catheterization laboratory. This manuscript explores some of the more recent developments in noninvasive coronary angiography and discusses the use and utility of CCTA from an interventional cardiologist's perspective.

Modern Treatment of Pulmonary Embolism (USCDT vs MT): Results From a Real-World, Big Data Analysis (REAL-PE).

Background: Advanced therapies are increasingly utilized to treat pulmonary embolism (PE). A unique data platform allows access to electronic health record data for comparison of the safety of PE therapies. Methods: All data from Truveta (Truveta, Inc) were analyzed (16 systems, 83,612,413 patients, 535,567 with PE). All patients treated with ultrasound-assisted catheter-directed thrombolysis (USCDT) (Boston Scientific) or mechanical thrombectomy (MT) (Inari Medical) for PE were identified. The primary analysis was based on index procedures performed from January 2009 to May 2023, and contemporary analysis on those performed from January 2018 to May 2023. Bleeding was assessed via direct laboratory analysis and transfusion administration documentation. International Society for Thrombosis and Hemostasis (ISTH) and Bleeding Academic Research Consortium (BARC) 3b definitions were recreated. Multiple logistic regression analysis of major bleeding was performed. In-hospital death and median length of stay were measured. Results: For the primary analysis, 2259 patients (N = 1577 USCDT, N = 682 MT) and for the contemporary analysis 1798 patients (N = 1137 USCDT, N = 661 MT) met the criteria. Incidence of hemoglobin reduction (>2 and >5 g/dL) and transfusions received were significantly higher among MT-treated patients in both analyses, as was ISTH and BARC 3b major bleeding (primary: ISTH MT 17.3% vs USCDT 12.4% P = .002; BARC 3b MT 15.4% vs USCDT 11.8% P = .019) (contemporary: ISTH MT 17.2% vs USCDT 11.0% P = .0002; BARC 3b MT 15.4% vs USCDT 10.6% P = .002). Regression analysis demonstrated that MT is associated with major bleeding. Median length of stay, all-cause 30-day readmission and in-hospital mortality were similar between groups. Intracranial hemorrhage was more common with MT. Conclusions: Major bleeding derived from direct laboratory and transfusion data occurred more frequently with MT vs USCDT. Intracranial hemorrhage was more common among MT-treated patients. In the absence of randomized data, these results provide guidance regarding the bleeding risk and safety of strategies for advanced PE therapy.

Skeletal muscle desmin alterations following revascularization in peripheral artery disease claudicants.

Peripheral artery disease (PAD) is characterized by varying severity of arterial stenosis, exercise induced claudication, malperfused tissue precluding normal healing and skeletal muscle dysfunction. Revascularization interventions improve circulation, but post-reperfusion changes within the skeletal muscle are not well characterized. This study investigates if revascularization enhanced hemodynamics increases walking performance with concurrent improvement of mitochondrial function and reverses abnormal skeletal muscle morphological features that develop with PAD. Fifty-eight patients completed walking performance testing and muscle biopsy before and 6 months after revascularization procedures. Muscle fiber morphology, desmin structure, and mitochondria respiration assessments before and after the revascularization were evaluated. Revascularization improved limb hemodynamics, walking function, and muscle morphology. Qualitatively not all participants recovered normal structural architecture of desmin in the myopathic myofibers after revascularization. Heterogenous responses in the recovery of desmin structure following revascularization may be caused by other underlying factors not reversed with hemodynamic improvements. Revascularization interventions clinically improve patient walking ability and can reverse the multiple subcellular functional and structural abnormalities in muscle cells. Further study is needed to characterize desmin structural remodeling with improvements in skeletal muscle morphology and function.

Safety and Efficacy of Radial Artery Access for Peripheral Vascular Intervention: A Single-Center Experience.

Radial artery (RA) access has been increasingly utilized for coronary procedures because of lower rates of access-site complications and improved patient satisfaction. However, limited data are available for RA access for peripheral vascular intervention (PVI). We performed a retrospective review of 143 patients who underwent PVI through RA access from February 2020 to September 2022 at a single institution. Baseline characteristics and follow-up data were ascertained from a prospectively maintained institutional database. Of 491 PVI, 156 (31.8%) were performed through the RA. Anatomical locations for intervention were the femoral (44.8%), iliac (31.1%), popliteal (9.6%) peroneal (2.7%), tibial (9.9%), and subclavian (1.9%) arteries. Procedural access was obtained through the right RA (92.9%), left RA (4.5%), or right ulnar artery (2.6%) using the 6 French R2P Destination Slender sheath in 85, 105, and 119 cm lengths. Atherectomy was used in 34.7%. Mean contrast volume was 105.5 ml and the average fluoroscopy time was 18.5 minutes. Conversion to femoral access occurred in 3 cases (1.9%) because of arterial spasm and noncrossable lesions. Concomitant pedal access occurred in 2 cases (1.3%). Periprocedural complication rate was 3.84%, of which access-site hematoma was most common (3.2%); none required blood transfusion, surgical intervention, or additional hospital stay. There was 1 case (0.64%) of in-hospital stroke. The mortality rate at 30-day, 6-month, and 1-year was 1.4%, 2.8%, and 4.2%, respectively. In conclusion, RA access is feasible for diverse PVI, and future studies are needed to assess safety and benefit compared with femoral artery access.

Impact of a Quality Improvement Initiative on Medical Management of Veterans With Peripheral Artery Disease.

Guideline-directed medical therapy (GDMT) for peripheral artery disease (PAD) remains severely underused. Prevention of Amputation in Veterans Everywhere (PAVE) is a screening program designed to prevent or delay major lower extremity amputation. This study aimed to determine whether diagnosis of PAD through the PAVE program improves the prescription of GDMT in veterans with asymptomatic PAD. Patients enrolled into the PAVE program from our institution from 2020 to 2021 were included. Patients with an abnormal ankle-brachial index (ABI), defined as ABI <0.9 or >1.2, were selected for further analysis. Primary outcome was adherence to GDMT, following class I and class IIa recommendations. Secondary outcomes included changes in low-density lipoprotein (LDL), blood pressure, and hemoglobin A1c (HbA1c). A total of 6,313 patients were enrolled into the PAVE program between 2020 and 2021. Of these, 211 had abnormal ABI and were included in our analysis. With enrollment into PAVE, there was significant increase in the prescription of aspirin (74.4% vs 64.9%, p = 0.044) and statins (91.5% vs 82%, p = 0.006). The overall adherence to GDMT significantly increased (56.9% vs 38.9%, p <0.001). The number of patients needed to enroll in PAVE to improve GDMT adherence is 5.6 (95% confidence interval 3.6 to 12.3). Patients enrolled into PAVE program saw significant decreases in HbA1c, with mean decrease of 0.3 (p = 0.012) and a decrease in LDL, with a mean decrease of 6.2 (p = 0.01). In conclusion, enrollment into an amputation prevention program secondarily increased adherence to GDMT, driven by increases in the prescription of statins and aspirin, with resulting decreases in HbA1c and LDL.

Real-World Experience and Outcomes With Percutaneous Coronary Intervention for Protected Versus Unprotected Left Main Coronary Artery Disease: Insights from the Veteran Affairs Clinical Assessment Reporting and Tracking Program.

The practice patterns and outcomes of protected left main (PLM) and unprotected left main (ULM) percutaneous coronary intervention (PCI) are not well defined in contemporary US clinical practice. Data were collected from all Veteran Affairs catheterization laboratories participating in the Clinical Assessment Reporting and Tracking Program between 2009 and 2019. The analysis included 4,351 patients who underwent left main PCI, of whom 1,306 pairs of PLM and ULM PCI were included in a propensity-matched cohort. Selected temporal trends were also assessed. The primary outcome was major adverse cardiovascular event (MACE) outcomes at 1 year, which was defined as a composite of all-cause mortality, rehospitalization for myocardial infarction (MI), rehospitalization for stroke, or urgent revascularization. Patients who underwent ULM PCI compared with patients who underwent PLM PCI were older (age 71.5 vs 69.2 years, p <0.001), more clinically complex, and more likely to present with acute coronary syndrome. In the propensity-matched cohort, radial access was used more often for ULM PCI (21% [273] vs 14% [185], p <0.001) and ULM PCI was more likely to involve the left main bifurcation (22% vs 14%, p = 0.003) and require mechanical circulatory support (10% [134] vs 1% [17], p <0.001). The 1-year MACEs occurred more frequently with ULM PCI than PLM PCI (22% [289] vs 16% [215], p ≤0.001) and all-cause mortality was also higher (16% [213] vs 10% [125], p ≤0.001). In the matched cohort, there was a low incidence of rehospitalization for MI (4% [48] ULM vs 4% [48] PLM, p = 1.000) or revascularization (7% [94] ULM vs 6% [84] PLM, p = 0.485). In this real-world experience, patients who underwent PLM PCI had better 1-year outcomes than those who underwent ULM PCI; however, in both groups, there was a high rate of mortality and MACEs at 1 year despite a relatively low rate of MI or revascularization.

Addressing Barriers to Entry and Retention of Women in Interventional Vascular Specialties With Proposed Solutions: A Scientific Statement From the American Heart Association.

Representation of women in interventional vascular fields (interventional cardiology, interventional radiology, and vascular surgery) lags behind that in other specialties. With women representing half of all medical school graduates, encouraging parity of women in these fields needs to start in medical school. Barriers to pursuing careers in vascular intervention include insufficient exposure during core clerkships, early mentorship, visibility of women in the field, length of training, lifestyle considerations, work culture and environment, and concerns about radiation exposure. This scientific statement highlights potential solutions for both the real and perceived barriers that women may face in pursuing careers in vascular intervention, including streamlining of training (as both interventional radiology and vascular surgery have done with a resultant increase in percentage of women trainees), standardization of institutional promotion of women in leadership, and professional and industry partnerships for the retention and advancement of women.

Treatment Variability Among Patients Hospitalized for Chronic Limb-Threatening Ischemia: An Analysis of the 2016 to 2018 US National Inpatient Sample.

BACKGROUND: Little is known about treatment variability across US hospitals for patients with chronic limb-threatening ischemia (CLTI). METHODS AND RESULTS: Data were collected from the 2016 to 2018 National Inpatient Sample. All patients aged ≥18 years, admitted to nonfederal US hospitals with a primary diagnosis of CLTI, were identified. Patients were classified according to their clinical presentation (rest pain, skin ulceration, or gangrene) and were further characterized according to the treatment strategy used. The primary outcome of interest was variability in CLTI treatment, as characterized by the median odds ratio. The median odds ratio is defined as the likelihood that 2 similar patients would be treated with a given modality at 1 versus another randomly selected hospital. There were 15 896 (weighted n=79 480) hospitalizations identified where CLTI was the primary diagnosis. Medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, and amputation alone were used in 4057 (25%), 5390 (34%), 3733 (24%), and 2716 (17%) patients, respectively. After adjusting for both patient- and hospital-related factors, the median odds ratio (95% CI) for medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, any revascularization, and amputation alone were 1.28 (1.19-1.38), 1.86 (1.77-1.95), 1.65 (1.55-1.74), 1.37 (1.28-1.45), and 1.42 (1.27-1.55), respectively. CONCLUSIONS: Significant variability in CLTI treatment exists across US hospitals and is not fully explained by patient or hospital characteristics.