Publications

OBJECTIVE: The application of 2 distinct and simultaneously applied drug-delivery platforms for the treatment of peripheral artery disease (PAD) has not been studied. This study investigated the outcomes of femoropopliteal disease treated with drug-coated balloon (DCB) followed by placement of drug-eluting stent (DES) when a bail-out procedure is required.

METHODS: This was a single-center, retrospective study enrolling 22 consecutive patients (23 limbs) treated with DCB + DES. Bail-out stenting was performed for flow-limiting postangioplasty dissections and/or suboptimal angiographic result, such as residual stenosis. Procedural success (<30% residual stenosis) and the incidence of major adverse limb event (MALE) during an average follow-up of 15.2 months were estimated.

RESULTS: Among the 22 patients (23 limbs), 14 presented with claudication and 8 with critical limb ischemia. The majority of the lesions were Trans-Atlantic Inter-Society Consensus class C/D, with a mean lesion length of 321 ± 130 mm. DCB angioplasty was performed with Stellarex (Philips) in 6 cases and In.Pact DCB (Medtronic) in 16 cases. Eluvia DES (Boston Scientific) was used for bail-out stenting in all cases (in 10 limbs for flow-limiting dissection and in 13 limbs for suboptimal angiographic result due to significant residual stenosis and/or recoil). A single Eluvia DES was used in 15 cases, while multiple Eluvia DESs were used in 8 cases. Procedural success was achieved in all but 1 case where persistent recoil occurred in a heavily calcified lesion. During an average follow-up of 15 months, restenosis or reocclusion of the target vessel was observed in 6 cases (26.1%), although only 3 patients required repeat revascularization (13.0%). During follow-up, 1 death and 1 major amputation occurred, both in patients who had originally presented with critical limb ischemia. Additionally, on routine duplex ultrasound, there were no cases of aneurysm formation at the sites of Eluvia stent placement.

CONCLUSION: DCB with provisional DES implantation could be a viable treatment option for cases of suboptimal DCB results, without apparent additional cardiovascular or limb-related risks. Additional studies are needed to determine the risks and benefits of double-dose paclitaxel approach, especially for those patients with significant residual stenosis after DCB.

BACKGROUND: Women with coronary artery disease are shown to have worse outcomes after percutaneous coronary intervention compared with men; however, less is known about sex-based outcomes following lower extremity peripheral vascular intervention (PVI) for symptomatic peripheral artery disease. The study aims to assess whether female sex is independently associated with periprocedural complications in patients undergoing PVI.

METHODS: Analysis includes patients undergoing lower extremity PVI from September 2016 to March 2020 from the Vascular Quality Initiative registry. Multivariate logistic regression was used to assess the independent association of female sex with post-PVI complications.

RESULTS: Of the 119 620 patients included, 47 316 (39.6%) were women. Analysis reflected that women were at higher risk of developing access site complications, including any hematoma (odds ratio [OR], 1.45 [1.35-1.57]), hematoma requiring transfusion (OR, 2.24 [1.82-2.76]; P<0.001), hematoma requiring surgery (OR, 1.49 [1.19-1.86]; P<0.001), pseudoaneurysm (OR, 1.69 [1.39-2.05]; P<0.001), and access site occlusion (OR, 1.89 [1.15-3.08]; P<0.001). Women also faced higher risks of target lesion dissection (OR, 1.36 [1.26-1.46]; P<0.001), above-knee amputation (OR, 1.37 [1.18-1.58]; P<0.001), and in-hospital mortality (OR, 1.21 [1.07-1.38]; P=0.003).

CONCLUSIONS: In a contemporary cohort, women undergoing lower extremity PVI for symptomatic peripheral artery disease were at higher risk than men of developing periprocedural complications, including moderate or severe access site bleeding, above-knee amputation, and in-hospital mortality. This increased risk persisted despite adjustment for differences in baseline patient or procedural characteristics and warrants further investigation.

Although angiography has been the primary imaging modality used in peripheral vascular intervention, this technique has major limitations due to the evaluation of three-dimensional vessels in two dimensions. Intravascular ultrasound (IVUS) is an important adjunctive tool that can address some of these limitations. This systematic review assesses the appropriateness of IVUS as an imaging modality for guiding peripheral intervention through evidence collection and clinical appraisal of studies. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a cohort of 48 studies (29 arterial; 19 venous) detailing IVUS use in peripheral vascular intervention were extracted. Qualitative assessment of the studies evaluated pre- and postprocedure efficacy of IVUS and revealed that IVUS-guided peripheral intervention in arterial and venous diagnosis and treatment was superior to other imaging techniques alone. Each study in the cohort was further assessed for reliability and validity using the Oxford Centre for Evidence Based Medicine (CEBM) level of evidence scale. The majority of both arterial (79.3%) and venous (73.7%) studies received a 2b rating, the second highest level of evidence rating. The evidence to date indicates that IVUS results in better clinical outcomes overall and should be more widely adopted as an adjunctive imaging modality during peripheral intervention. (PROSPERO Registration No.: CRD42021232353).

OBJECTIVE: The aim of this study was to evaluate the association of HIV infection with outcomes among people hospitalized with COVID-19.

DESIGN: A prospectively planned analysis of the American Heart Association's COVID-19 Cardiovascular Disease Registry.

SETTING: One hundred and seven academic and community hospitals in the United States from March through December 2020.

PARTICIPANTS: Consecutive sample of 21 528 adults hospitalized with COVID-19 at participating hospitals.

MAIN OUTCOME AND MEASURE: Primary outcome was predefined as in-hospital mortality. We used hierarchical mixed effects models to assess the association of HIV with in-hospital mortality accounting for patient demographics, comorbidities, and clustering by hospital. Secondary outcomes included major adverse cardiac events (MACE), severity of illness, and length of stay (LOS).

RESULTS: The registry included 220 people with HIV (PWH). PWH were younger and more likely to be male, Non-Hispanic Black, on Medicaid, and active tobacco users. Of the study population, 36 PWH (16.4%) died compared with 3290 (15.4%) without HIV [risk ratio 1.06; 95% confidence interval (95% CI) 0.79-1.43; P = 0.71]. After adjustment for age, sex, race, and insurance, HIV was not associated with in-hospital mortality (aOR 1.12; 95% CI 0.76-1.64; P = 0.58) with no change in effect after adding BMI and comorbidities (aOR 1.14; 95% CI 0.78-1.68; P = 0.51). HIV was not associated with MACE (aOR 0.99; 95% CI 0.69-1.44, P = 0.91), COVID severity (aOR 0.96; 95% CI 0.62-1.50; P = 0.86), or LOS (aOR 1.03; 95% CI 0.76-1.66; P = 0.21).

CONCLUSION: In the largest study of PWH hospitalized with COVID-19 in the United States to date, we did not find significant associations between HIV and adverse outcomes including in-hospital mortality, MACE, or severity of illness.

OBJECTIVES: This study was designed to compare efficiency and quality metrics between percutaneous coronary intervention (PCI) procedures using optical coherence tomography (OCT) guided by a variable workflow versus a standardized workflow in a real-world population.

BACKGROUND: The LightLab (LL) Initiative was designed to evaluate the impact of a standardized OCT workflow during PCI to address barriers to adoption.

METHODS: The LL Initiative was a multicenter, prospective, observational study. PCI efficiency data were collected from 1/21/19 to 1/8/21 from 45 physicians at 17 US centers. OCT-guided PCIs were compared between baseline phase (variable workflow; N = 383) and the LL workflow utilization phase (N = 447). The LL workflow uses OCT to assess lesion Morphology, Length and Diameter, and then optimize outcomes by correcting for Medial dissection, stent mal-Apposition, and under-eXpansion (MLD MAX). Matching based on propensity scores was used to control for differences between PCIs.

RESULTS: After propensity matching, 291 paired procedures were included. Integration of the LL versus variable workflow resulted in no difference in procedure time (51 min vs. 51 min, p = 0.93). There was a reduction in radiation exposure (1124 mGy vs. 1493 mGy, p < 0.0001) and contrast volume (160 cc vs. 172 cc, p < 0.001). The LL workflow decreased the proportion of underexpanded lesions (34% vs. 54%, p < 0.0001) and improved minimum stent expansion (85% vs. 79%, p < 0.0001). Number of noncompliant balloons used was reduced with the LL workflow. (2.0 vs. 1.7, p < 0.01).

CONCLUSIONS: These data suggest that standardizing imaging with the LL workflow may overcome barriers to imaging and improve PCI outcomes without prolonging procedures.

OBJECTIVES: To understand the prevalence of malnutrition and its association with chronic limb-threatening ischemia (CLTI) outcomes; to clarify the differential impact of revascularization methods on outcomes; to assess the ability of the CLTI Frailty Risk Score (CLTI-FRS) to predict adverse events in patients hospitalized with CLTI.

BACKGROUND: Despite advances in the management of CLTI, a majority still undergo major amputation, and a minority heal within 6 months. There is a lack of validated assessment tools for the identification and management of frailty and malnutrition in these patients.

METHODS: Using the National Inpatient Sample from January 2012 to September 2015, we identified all patients with CLTI using International Classification of Diseases Ninth Edition Clinical Modification codes. The cohort was divided into three groups according to nutritional status. Multivariable regression analysis was used to analyze the interaction between malnutrition and outcomes of interest.

RESULTS: Of 1,414,080 CLTI-related hospitalizations, 163,835 (11.6%) were malnourished, 332,855 (23.5%) patients were frail, 917,390 (64.9%) were well-nourished. In-hospital mortality, major amputation, the average length of stay, and hospital costs were highest among malnourished or frail patients and lowest in well-nourished patients (p < 0.001). Malnourished and frail patients were observed to have lower rates of mortality with endovascular revascularization as compared to surgical (adjusted odds ratios: 0.675 [0.533-0.854; p = 0.001]).

CONCLUSION: Many patients with CLTI are malnourished or frail, and this is associated with mortality and amputation. Both malnourished and frail patients were observed to have a mortality benefit with a less invasive approach to revascularization. Better assessment of nutritional and frailty status of CLTI patients may guide therapy and help prevent amputation and death.

OBJECTIVES: The study describes the evolution of optical coherence tomography (OCT) adoption and performance during percutaneous coronary intervention (PCI) following implementation of a standardized LightLab (LL) workflow.

BACKGROUND: The purpose of the LL Clinical Initiative was to evaluate the impact of a standardized workflow on physician efficiency, decision making, and image quality.

METHODS: The LL Clinical Initiative is a multicenter, prospective, observational clinical program. Data were collected from 48 physicians at 17 U.S. centers from 01/21/19 to 06/08/21. The study included 401 OCT-guided PCIs during the baseline phase and 1898 during the LL workflow phases. The baseline phase consisted of physicians utilizing OCT at their discretion. After completing the baseline phase, the workflow progressed through multiple phases culminating in the expansion phase, which focused on addressing greater procedural complexity. The LL workflow utilized OCT to assess plaque Morphology, lesion Length, and vessel Diameter before PCI, and optimized results by treating Medial edge dissection, stent mal-Apposition, and stent under-eXpansion (MLD MAX). High-level summary statistics were generated to elucidate trends.

RESULTS: After program implementation, there was a rise in the number of PCIs where the LL workflow was utilized compared to the baseline phase (68% during the expansion phase vs. 41% at baseline; p for trend <0.0001). Adoption of the LL workflow was associated with progressively greater procedural and lesion complexity when OCT was performed pre- and post-PCI (87% vs. 52%, p < 0.0001; 55% vs. 37%, p < 0.0001, respectively). In addition, the quality of OCT imaging obtained improved after LL workflow introduction, with over 95% of pre- and post-PCI pullback quality considered usable during the expansion phase. Finally, there was a reduction in time spent on OCT interpretation, both pre-PCI (4.6 min vs. 7.5 min, p < 0.0001) and post-PCI (2.9 min vs. 5.3 min, p < 0.0001).

CONCLUSIONS: After completion of the standardized OCT-guided workflow, there was greater uptake of OCT imaging, incorporation in more complex procedures, procedural efficiency, and image quality.