Publications by Year: 2022

2022

Secemsky EA, Mosarla RC, Rosenfield K, Kohi M, Lichtenberg M, Meissner M, Varcoe R, Holden A, Jaff MR, Chalyan D, Clair D, Hawkins BM, Parikh SA. Appropriate Use of Intravascular Ultrasound During Arterial and Venous Lower Extremity Interventions. JACC. Cardiovascular interventions. 2022;15(15):1558–1568. PMID: 35926922

BACKGROUND: There has been growing use of intravascular ultrasound (IVUS) during lower extremity arterial and venous revascularization. Observational data suggest that the use of IVUS can improve periprocedural and long-term outcomes, but largescale prospective data remain limited. Consensus opinion regarding the appropriate use of IVUS during peripheral intervention is needed.

OBJECTIVES: The purpose of this consensus document is to provide guidance on the appropriate use of IVUS in various phases of peripheral arterial and venous interventions.

METHODS: A 12-member writing committee was convened to derive consensus regarding the appropriate clinical scenarios for use of peripheral IVUS. The group iteratively created a 72-question survey representing 12 lower extremity arterial interventional scenarios. Separately, a 40-question survey representing 8 iliofemoral venous interventional scenarios was constructed. Clinical scenarios were categorized by interventional phases: preintervention, intraprocedure, and postintervention optimization. Thirty international vascular experts (15 for each survey) anonymously completed the survey instrument. Results were categorized by appropriateness using the median value and disseminated to the voting panel to reevaluate for any disagreement.

RESULTS: Consensus opinion concluded that IVUS use may be appropriate during the preintervention phase for evaluating the etiology of vessel occlusion and plaque morphology in the iliac and femoropopliteal arteries. IVUS was otherwise rated as appropriate during iliac and femoropopliteal revascularization in most other preintervention scenarios, as well as intraprocedural and postprocedural optimization phases. IVUS was rated appropriate in all interventional phases for the tibial arteries. For iliofemoral venous interventions, IVUS was rated as appropriate in all interventional phases.

CONCLUSIONS: Expert consensus can help define clinical procedural scenarios in which peripheral IVUS may have value during lower extremity arterial and venous intervention while additional prospective data are collected.

Mihatov N, Mosarla RC, Kirtane AJ, Parikh SA, Rosenfield K, Chen S, Song Y, Yeh RW, Secemsky EA. Outcomes Associated With Peripheral Artery Disease in Myocardial Infarction With Cardiogenic Shock. Journal of the American College of Cardiology. 2022;79(13):1223–1235. PMID: 35361344

BACKGROUND: Mortality rates for patients presenting with acute myocardial infarction (AMI) and cardiogenic shock (CS) remain high despite advances in revascularization strategies and mechanical circulatory support (MCS) devices.

OBJECTIVES: This study sought to elucidate the association between comorbid lower extremity peripheral artery disease (PAD) and outcomes in CS and AMI.

METHODS: PAD status was defined in Medicare beneficiaries hospitalized with CS and AMI from October 1, 2015 to June 30, 2018. Primary outcomes ascertained through December 31, 2018 included in- and out-of-hospital mortality. Secondary outcomes included bleeding, amputation, stroke, and lower extremity revascularization. Multivariable regression models with adjustment for confounders were used to estimate risk. Subgroup analyses included patients treated with MCS and those who underwent coronary revascularization.

RESULTS: Among 71,690 patients, 5.9% (N = 4,259) had PAD. Mean age was 77.8 ± 7.9 years, 58.7% were male, and 84.3% were White. Cumulative in-hospital mortality was 47.2%, with greater risk among those with PAD (56.3% vs 46.6% without PAD; adjusted OR: 1.50; 95% CI: 1.40-1.59). PAD patients also had greater risk of in-hospital amputation (1.6% vs 0.2%; adjusted OR: 7.0; 95% CI: 5.26-9.37) and out-of-hospital mortality (67.9% vs 40.7%; adjusted HR: 1.78; 95% CI: 1.67-1.90). MCS was less frequently utilized in PAD patients (21.5% vs 38.6% without PAD; P < 0.001) and was associated with higher mortality, need for lower extremity revascularization, and amputation risk. Findings were consistent in patients who underwent coronary revascularization.

CONCLUSIONS: Among patients presenting with AMI and CS, PAD was associated with worse limb outcomes and survival. In addition to lower MCS utilization rates, those with PAD who received MCS had increased mortality, lower extremity revascularization, and amputation rates.

Krawisz AK, Natesan S, Wadhera RK, Chen S, Song Y, Yeh RW, Jaff MR, Giri J, Julien H, Secemsky EA. Differences in Comorbidities Explain Black-White Disparities in Outcomes After Femoropopliteal Endovascular Intervention. Circulation. 2022;146(3):191–200. PMID: 35695005

BACKGROUND: Black adults have a higher incidence of peripheral artery disease and limb amputations than White adults in the United States. Given that peripheral endovascular intervention (PVI) is now the primary revascularization strategy for peripheral artery disease, it is important to understand whether racial differences exist in PVI incidence and outcomes.

METHODS: Data from fee-for-service Medicare beneficiaries ≥66 years of age from 2016 to 2018 were evaluated to determine age- and sex-standardized population-level incidences of femoropopliteal PVI among Black and White adults over the 3-year study period. Patients' first inpatient or outpatient PVIs were identified through claims codes. Age- and sex-standardized risks of the composite outcome of death and major amputation within 1 year of PVI were examined by race.

RESULTS: Black adults underwent 928 PVIs per 100 000 Black beneficiaries compared with 530 PVIs per 100 000 White beneficiaries (risk ratio, 1.75 [95% CI, 1.73-1.77]; P<0.01). Black adults who underwent PVI were younger (mean age, 74.5 years versus 76.4 years; P<0.01), were more likely to be female (52.8% versus 42.7%; P<0.01), and had a higher burden of diabetes (70.6% versus 56.0%; P<0.01), chronic kidney disease (67.5% versus 56.6%; P<0.01), and heart failure (47.4% versus 41.7%; P<0.01) than White adults. When analyzed by indication for revascularization, Black adults were more likely to undergo PVI for chronic limb-threatening ischemia than White adults (13 023 per 21 352 [61.0%] versus 59 956 per 120 049 [49.9%]; P<0.01). There was a strong association between Black race and the composite outcome at 1 year (odds ratio, 1.21 [95% CI, 1.16-1.25]). This association persisted after adjustment for socioeconomic status (odds ratio, 1.08 [95% CI, 1.03-1.13]) but was eliminated after adjustment for comorbidities (odds ratio, 0.96 [95% CI, 0.92-1.01]).

CONCLUSIONS: Among fee-for-service Medicare beneficiaries, Black adults had substantially higher population-level PVI incidence and were significantly more likely to experience adverse events after PVI than White adults. The association between Black race and adverse outcomes appears to be driven by a higher burden of comorbidities. This analysis emphasizes the critical need for early identification and aggressive management of peripheral artery disease risk factors and comorbidities to reduce Black-White disparities in the development and progression of peripheral artery disease and the risk of adverse events after PVI.

Mosarla RC, Armstrong E, Bitton-Faiwiszewski Y, Schneider PA, Secemsky EA. State-of-the-Art Endovascular Therapies for the Femoropopliteal Segment: Are We There Yet?. Journal of the Society for Cardiovascular Angiography & Interventions. 2022;1(5). PMID: 36268042

Peripheral arterial disease is an increasingly prevalent condition with significant associated morbidity, mortality, and health care expenditure. Endovascular interventions are appropriate for most patients with either ongoing symptoms of intermittent claudication despite lifestyle and medical optimization or chronic limb-threatening ischemia. The femoropopliteal segment is the most common arterial culprit responsible for claudication and the most commonly revascularized segment. Endovascular approaches to revascularization of the femoropopliteal segment are advancing with an evolving landscape of techniques for arterial access, device-based therapies, vessel preparation, and intraprocedural imaging. These advances have been marked by debate and controversy, notably related to the safety of paclitaxel-based devices and necessity of atherectomy. In this review, we provide a critical overview of the current evidence, practice patterns, emerging evidence, and technological advances for endovascular intervention of the femoropopliteal arterial segment.

Teng AE, Kennedy KF, Parikh R V, Armstrong EJ, Hsue PY, Secemsky EA. Temporal trends and outcomes of peripheral artery disease revascularization and amputation among the HIV population. AIDS (London, England). 2022;36(12):1717–1724. PMID: 35848583

OBJECTIVE: With antiretroviral therapy, people with HIV (PWH) are developing age-related diseases, including peripheral arterial disease (PAD). This study examined frequency and outcomes of peripheral vascular intervention (PVI) and primary amputation in PWH.

DESIGN: We used the National Inpatient Sample (NIS) database to examine demographics, comorbidities, and temporal trends among PVI and primary amputation admissions by HIV status from 2012 to 2018.

METHODS: Inverse probability of treatment weighting was used to calculate adjusted odds of in-hospital death and amputation. Cost of hospitalization and length of stay were compared by HIV status and revascularization approach.

RESULTS: Of the 347 824 hospitalizations for PVI/amputation, 0.6% were PWH, which was stable over time. PWH had more renal and hepatic disease, whereas uninfected individuals had more traditional PAD risk factors. 55.2% of HIV+ admissions were endovascular compared with 49.3% in HIV- admissions, and 28.9% of the HIV+ admissions were elective compared with 42.1% among HIV-. HIV status did not impact amputation following PVI. In-hospital death was similar between groups following PVI or primary amputation. PWH had lower costs of hospitalization and a trend towards shorter hospital stays.

CONCLUSION: Although PWH are developing more age-related chronic illnesses, the number of PAD-associated procedures has remained flat. Despite being younger with fewer traditional PAD risk factors, PWH had higher rates of unplanned PVI admissions and endovascular revascularization but similar in-hospital outcomes. These findings suggest PWH have different risk factors for PAD and are likely underdiagnosed and undertreated, whereas those who are treated have similar outcomes to the general population.

Divakaran S, Parikh SA, Hawkins BM, Chen S, Song Y, Banerjee S, Rosenfield K, Secemsky EA. Temporal Trends, Practice Variation, and Associated Outcomes With IVUS Use During Peripheral Arterial Intervention. JACC. Cardiovascular interventions. 2022;15(20):2080–2090. PMID: 36265940

BACKGROUND: Intravascular ultrasound (IVUS) has been shown in limited prospective studies to improve procedural outcomes for patients undergoing lower extremity peripheral arterial intervention (PVI).

OBJECTIVES: The authors aimed to study temporal trends, practice variation, and associated outcomes with the use of IVUS during PVI among Medicare beneficiaries.

METHODS: All PVIs performed from 2016 to 2019 among Medicare beneficiaries aged >65 years were included. Temporal trends in IVUS use were stratified by procedural location (inpatient, outpatient, or ambulatory surgery center [ASC]/office-based laboratory [OBL]) and physician specialty. The primary outcome was major adverse limb events (MALE). Inverse probability weighting was used to account for differences in baseline characteristics. Cox regression with competing risks was used to estimate weighted hazard ratios.

RESULTS: During the study period, 543,488 PVIs were included, of which 63,372 (11.7%) used IVUS. A substantial growth in IVUS use was observed, which was driven by procedures performed in ASCs/OBLs (23.6% increase from quarter 1 of 2016 through quarter 4 of 2019). Among operators who used IVUS, there was also notable variation in use (median operator use 5.4% of cases; IQR: 2.2%-15.0%; range, <1%-100%). In weighted analysis, IVUS use during PVI was associated with a lower risk of MALE through a median of 514 days (adjusted hazard ratio: 0.73; 95% CI: 0.70-0.75; P < 0.0001).

CONCLUSIONS: In contemporary nationwide data, IVUS use during PVI has increased since 2016, driven by growth in the ASC/OBL setting. However, there remains substantial variation in operator practice. When used during PVI, IVUS was associated with a lower risk of short- and long-term MALE.

Earle W, Abdallah G, Meagher S, Shen K, Gibson M, Ho KKL, Secemsky EA. Reducing use of triple therapy after percutaneous coronary intervention: Results from a hospital-wide quality improvement initiative. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2022;100(6):941–947. PMID: 36183363

BACKGROUND: Trials have shown that for patients on oral anticoagulants (OAC), a short course of dual antiplatelet therapy (DAPT) with OAC reduces post-percutaneous coronary intervention (PCI) bleeding without increasing ischemic events. Adoption of this strategy has been variable. We evaluated the impact of an institutional quality improvement (QI) initiative to reduce the use of triple therapy (TT, OAC + DAPT) and improve discharge communication post-PCI.

METHODS: A hospital-wide QI initiative was developed to minimize time on TT post-PCI. Interventions included institutional guidelines emphasizing discharge on OAC with a P2Y12 inhibitor or reducing TT duration to ≤30 days, changes to the computerized decision-support system, and an educational curriculum for house staff. PCI patients 18 months before and after the initiative (2017-2020) were reviewed along with a faculty survey assessing prescribing practices to evaluate the efficacy of the interventions.

RESULTS: Among 2797 PCIs reviewed, 431 were included based on OAC at discharge: 24.9% female, 80.1% White, and the mean age was 74 years. The most common indications for OAC were atrial fibrillation (70.1%) and left ventricular dysfunction (11.4%). Mean duration of TT decreased (58.7-37.8 days, p = 0.02) and patients discharged on TT ≤ 30 days increased (24%-37%, p = 0.019) after intervention. Of surveyed faculty (n = 20), 75.0% reported familiarity with the guidelines and 57.9% reported using them to make therapy decisions.

CONCLUSIONS: Following the implementation of a QI initiative, fewer patients were discharged on TT and shorter durations of TT were used. Similar initiatives should be considered at institutions with the prevalent use of TT post-PCI.