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.

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.

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.

Infective Endocarditis Complicated With a Large Left Coronary Cusp Aneurysm: A Condition With Undefined Natural History and Treatment.

The natural history and treatment of an aortic cusp aneurysm with or without rupture because of native aortic valve infective endocarditis (NAV-IE) have not been well defined. This may explain why current guidelines for the management of valvular heart disease do not include this complication as an indication for surgical aortic valve replacement or repair or transcatheter aortic valve replacement (TAVR). We describe herein the first case of a man aged 76 years with multiple co-morbidities with a NAV-IE associated large left coronary cusp aneurysm with subsequent rupture and consequent severe aortic regurgitation and heart failure for which he underwent an off-label successful TAVR. This patient's scenario suggests that a cusp aneurysm because of NAV-IE poses a high risk for subsequent rupture, severe aortic regurgitation, and heart failure. In conclusion, TAVR may be a reasonable alternative to high-risk surgical aortic valve replacement in patients with NAV-IE associated cusp aneurysms with or without but impending rupture.

Outcomes of Percutaneous Coronary Intervention for Protected versus Unprotected Left Main Coronary Artery Disease: Insights from the VA CART Program.

Background: Practice patterns and outcomes of protected left main (PLM) and unprotected left main (ULM) percutaneous coronary intervention (PCI), as well as the differences between these types of PCI, are not well defined in real-world clinical practice. Methods: Data collected from all Veteran Affairs (VA) catheterization laboratories participating in the Clinical Assessment Reporting and Tracking Program between 2009 and 2019. The analysis included 4,351 patients undergoing left main PCI, of which 1,306 pairs of PLM and ULM PCI were included in a propensity matched cohort. Patients and procedural characteristics were compared between PLM and ULM PCI. Temporal trends were also assessed. Peri-procedural and one-year major adverse cardiovascular events (MACE) were compared using cumulative incidence plots. The primary outcome was 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. Results: ULM PCI patients in comparison to PLM PCI were older (71.5 vs 69.2; P < 0.001), more clinically complex and more likely to present with ACS. 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 LM bifurcation (22% vs 14%; P = 0.003) and require mechanical circulatory support (10% [134] vs 1% [17]; P <0.001). One-year MACE occurred more frequently with ULM PCI compared to 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). Conclusions: Veterans undergoing PLM PCI had better one-year outcomes than those undergoing ULM PCI, but in both groups there was a high rate of mortality and MACE at one-year despite a relatively low rate of MI or revascularization.

Causes of Malfunction of Bioprostheses Inserted Percutaneously in the Aortic Valve Position in Patients Whose Native Aortic Valve Was Congenitally Bicuspid and Stenotic.

Transcatheter aortic valve implantation (TAVI) has brought in recent years relief of cardiac-induced symptoms to a large number of patients with aortic stenosis. Whether it is better to use TAVI for the treatment of aortic valve stenosis superimposed on a congenitally bicuspid valve has been debated in contrast to its proved usefulness in aortic valve stenosis involving a tricuspid aortic valve. From January 2020 to March 2023, surgical aortic valve replacement of TAVI valve and native aortic valve was done in 6 patients. The clinical findings of the patients and morphologic findings from the surgical specimens submitted to the cardiac pathology department were subsequently examined. All the 6 native aortic valves had bicuspid configuration. The TAVI valve in each patient was excised from 9 to 88 months (mean 36 months) after it had been implanted because of paravalvular leak in 4, severe stenosis of the prosthetic valve in 1, and bioprosthetic cuspal degeneration in 1. Prosthetic valve endocarditis was clinically suspected in 2 patients, but the specimen culture was negative. Before surgical aortic valve replacement, 3 patients experienced stroke after TAVI. All 6 patients had low hemoglobin levels (mean 9.5 mg/100 ml) and low hematocrit levels (mean 29.5%). Reticulocyte count was available in 4 patients and was increased in all (mean 3.5%). When the stenotic native aortic valve configuration is bicuspid, the raphe tends to be calcified first and located perpendicular to the flow of the blood and may prevent the ring of the caged bioprosthesis from being transferred to the aortic wall, which is a requirement for full opening of the lumen of the bioprosthesis. Thus, thorough consideration needs to be made before performing TAVI in patients whose native aortic valve is stenotic and bicuspid.

Comparative Outcomes of Interventions for Femoropopliteal Chronic Total Occlusion Versus Non-Chronic Total Occlusion Lesions From the Multicenter XLPAD Registry.

Background Endovascular intervention of femoropopliteal chronic total occlusions (CTOs) is technically more complex. However, there is lack of comparative analysis between CTO and non-CTO femoropopliteal interventions. Methods and Results We report procedural details and outcomes of patients treated for femoropopliteal CTO and non-CTO lesions in the XLPAD (Excellence in Peripheral Artery Disease) registry (NCT01904851) between 2006 and 2019. Primary outcomes were procedural success and 1-year major adverse limb events, a composite of all-cause death, target limb revascularization, or major amputation. Analysis included 2895 patients (CTO: n=1516 patients; non-CTO: n=1379 patients) with 3658 lesions (CTO: n=1998 lesions; non-CTO: n=1660 lesions). Conventional balloon angioplasty (20.86% versus 33.48%, P<0.001) or drug-coated balloon angioplasty (1.26% versus 2.93%, P<0.001) were more frequent in the non-CTO group, whereas bare-metal stents (28.09% versus 20.22%, P<0.001) or covered stents (4.08% versus 1.83%, P<0.001) were more frequent in the CTO group. Debulking procedures were more commonly performed in the non-CTO group (41.44% versus 53.13%, P<0.001), despite a similar degree of calcification between the 2 groups. Procedural success was higher in the non-CTO group (90.12% versus 96.79%, P<0.001). Procedural complications were higher in the CTO group (7.21% versus 4.66%, P=0.002), mainly due to excess distal embolization (1.5% versus 0.6%, P=0.015). Adjusted 1-year major adverse limb events were higher in the CTO group (22.47% versus 18.77%, P=0.019), driven mainly by target limb revascularization (19.00% versus 15.34%, P=0.013). Conclusions Procedural success is lower for endovascular treatment of femoropopliteal CTO compared with non-CTO lesions. CTO lesions are associated with higher rates of periprocedural complications and reinterventions after 1 year.

Intravenous iron therapy among patients with heart failure and iron deficiency: An updated meta-analysis of randomized controlled trials.

Background: Randomized clinical trials (RCTs) evaluating the role of intravenous (IV) iron administration in patients with heart failure (HF) and iron deficiency (ID) have yielded inconsistent results. Methods: Electronic search of MEDLINE, EMBASE and OVID databases was performed until November 2022 for RCTs that evaluated the role of IV iron administration in patients with HF and ID. The main study outcomes were the composite of HF hospitalization or cardiovascular mortality, and individual outcome of HF hospitalization. Summary estimates were evaluated using random effects model. Results: The final analysis included 12 RCTs with 3,492 patients (1,831 patients in the IV iron group and 1,661 patients in the control group). The mean follow-up was 8.3 months. IV iron was associated with a lower incidence in the composite of HF hospitalization or cardiovascular mortality (31.9% vs. 45.3%; relative risk [RR] 0.72; 95% confidence interval [CI] 0.59-0.88) and individual outcome of HF hospitalization (28.4% vs. 42.2; RR 0.69; 95% CI 0.57-0.85). There was no significant difference between both groups in cardiovascular mortality (RR 0.88; 95% CI 0.75-1.04) and all-cause mortality (RR 0.95; 95% CI 0.83-1.09). IV iron was associated with lower New York Heart Association class and higher left ventricular ejection fraction (LVEF). Meta-regression analyses showed no effect modification for the main outcomes based on age, hemoglobin level, ferritin level or LVEF. Conclusion: Among patients with HF and ID, IV iron administration was associated with reduction in the composite of HF hospitalization or cardiovascular mortality and driven by a reduction in HF hospitalization.

Outcomes of Percutaneous Coronary Intervention for In-Stent Restenosis Versus De Novo Lesions: A Meta-Analysis.

Background In-stent restenosis (ISR) is commonly encountered even in the era of contemporary percutaneous coronary intervention (PCI). There is a paucity of data on the comparative outcomes of PCI for ISR lesions versus de novo lesions. Methods and Results An electronic search was conducted for MEDLINE, Cochrane, and Embase through August 2022 for studies comparing the clinical outcomes after PCI for ISR versus de novo lesions. The primary outcome was major adverse cardiac events. Data were pooled using a random-effects model. The final analysis included 12 studies, with a total of 708 391 patients, of whom 71 353 (10.3%) underwent PCI for ISR. The weighted follow-up duration was 29.1 months. Compared with de novo lesions, PCI for ISR was associated with a higher incidence of major adverse cardiac events (odds ratio [OR], 1.31 [95% CI, 1.18-1.46]). There was no difference on a subgroup analysis of chronic total occlusion lesions versus none (Pinteraction=0.69). PCI for ISR was associated with a higher incidence of all-cause mortality (OR, 1.03 [95% CI, 1.02-1.04]), myocardial infarction (OR, 1.20 [95% CI, 1.11-1.29]), target vessel revascularization (OR, 1.42 [95% CI, 1.29-1.55]), and stent thrombosis (OR, 1.44 [95% CI, 1.11-1.87]), but no difference in cardiovascular mortality (OR, 1.04 [95% CI, 0.90-1.20]). Conclusions PCI for ISR is associated with higher incidence of adverse cardiac events compared with PCI for de novo lesions. Future efforts should be directed toward prevention of ISR and exploring novel treatment strategies for ISR lesions.

Reproducibility of Femoropopliteal Artery Intravascular Ultrasound Imaging in Patients With Peripheral Artery Disease.

Despite increased use of intravascular ultrasound (IVUS) during peripheral artery interventions, evidence for reproducibility of IVUS measurements and its relation to angiography is lacking. Forty cross-sectional IVUS images of the femoropopliteal artery from 20 randomly selected patients enrolled in the XLPAD (Excellence in Peripheral Artery Disease) registry who underwent peripheral artery interventions and met criteria based on IVUS consensus guidelines were independently assessed by 2 blinded readers. IVUS images from 6 patients (40 images) were selected for angiographic correlation and met criteria for identifiable landmarks (e.g., stent edge and bifurcation). Lumen cross-sectional area (CSA), external elastic membrane (EEM) CSA, luminal diameter, and reference vessel diameter were repeatedly measured. The Lumen CSA and EEM CSA intra-observer agreement by Spearman rank-order correlation (ρ) was >0.993, intraclass correlation coefficient was >0.997, and repeatability coefficient was <1.34. For the interobserver measurement of luminal CSA and EEM CSA, the ρ = 0.742 and 0.764; intraclass correlation coefficient = 0.888 and 0.885; and repeatability coefficient = 7.24 and 11.34, respectively. A Bland-Altman plot for lumen and EEM CSA showed good reproducibility. For angiographic comparison, the ρ for luminal diameter, luminal area, and vessel area were 0.419, 0.414, and 0.649, respectively. Femoropopliteal IVUS measurements showed strong intra-observer and interobserver agreement; IVUS and angiographic measurements did not demonstrate a similar strong agreement.