Publications

2022

Natesan S, Mosarla RC, Parikh SA, Rosenfield K, Suomi J, Chalyan D, Jaff M, Secemsky EA. Intravascular ultrasound in peripheral venous and arterial interventions: A contemporary systematic review and grading of the quality of evidence. Vascular medicine (London, England). 2022;27(4):392–400. PMID: 35546056

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).

Khuddus MA, Darki A, Padaliya BB, West NEJ, Rapoza RJ, Buccola J, Amis G, Chehab BM, Secemsky EA, Investigators LI. Improving efficiency and operator proficiency during percutaneous coronary interventions utilizing a standardized optical coherence tomography workflow. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2022;100 Suppl 1:S14-S24. PMID: 36661365

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.

Durstenfeld MS, Sun K, Ma Y, Rodriguez F, Secemsky EA, Parikh R V, Hsue PY. Association of HIV infection with outcomes among adults hospitalized with COVID-19. AIDS (London, England). 2022;36(3):391–398. PMID: 34750295

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.

Karim AM, Li J, Panhwar MS, Arshad S, Shalabi S, Mena-Hurtado C, Aronow HD, Secemsky EA, Shishehbor MH. Impact of malnutrition and frailty on mortality and major amputation in patients with CLTI. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2022;99(4):1300–1309. PMID: 35114067

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.

Raja A, Osborn EA, Bergmark BA, Croce KD, Poulin MF, Tamez H, West N, Buccola J, Meinen J, Secemsky EA, Investigators LCI. OCT utilization: Summary statistics from the LightLab clinical initiative. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2022;100 Suppl 1:S36-S43. PMID: 36661366

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.

Carroll BJ, Beyer SE, Shanafelt C, Kabrhel C, Rali P, Rivera-Lebron B, Rosovsky R, Ross CB, Pinto DS, Secemsky EA. Interhospital Transfer for the Management of Acute Pulmonary Embolism. The American journal of medicine. 2022;135(4):531–535. PMID: 34954228

BACKGROUND: There are increasing treatment options for the management of acute pulmonary embolism (PE), though many are only available at tertiary care centers. Patients with acute pulmonary embolism with high-risk features are often transferred for consideration of such therapies. There are limited data describing outcomes in patients transferred with acute pulmonary embolism.

METHODS: We evaluated patients with acute pulmonary embolism at our tertiary care center from August 2012 through August 2018 and compared clinical characteristics, pulmonary embolism features, management, and outcomes in those transferred for acute pulmonary embolism to those that were not transferred.

RESULTS: Of 2050 patients with pulmonary embolism included in the study, 432 (21.1%) were transferred from an outside hospital with a known diagnosis of pulmonary embolism. Patients transferred had a lower rate of malignancy (22.2% vs 33.3%; P < .001) and median Charlson comorbidity index (3 vs 4; P < .001). A higher percentage of patients transferred were classified as intermediate- or high-risk pulmonary embolism (62.5% vs 43.0%; P <.001) and more frequently received advanced therapy beyond anticoagulation alone (12.5% vs 3.2%, P < .001). Overall survival to discharge was similar between groups, though definite pulmonary embolism-related mortality was higher in the transferred group (38.5% vs 9.4%, P = .004).

CONCLUSION: More than 1 in 5 patients treated for acute pulmonary embolism at a tertiary care center were transferred from an outside facility. Transferred patients had higher risk pulmonary embolism features, more often received advanced therapy, and had higher definite pulmonary embolism-related mortality. There are opportunities to further optimize outcomes of patients transferred for management of acute pulmonary embolism.

Zimetbaum P, Carroll BJ, Locke AH, Secemsky E, Schermerhorn M. Lead-Related Venous Obstruction in Patients With Implanted Cardiac Devices: JACC Review Topic of the Week. Journal of the American College of Cardiology. 2022;79(3):299–308. PMID: 35057916

Cardiac implantable electronic device implantation rates have increased in recent decades. Venous obstruction of the subclavian, brachiocephalic, or superior vena cava veins represents an important complication of implanted leads. These forms of venous obstruction can result in significant symptoms as well as present a barrier to the implantation of additional device leads. The risk factors for the development of these complications remain poorly understood, and diagnosis relies on clinical recognition and cross-sectional imaging. Anticoagulation remains the mainstay of treatment, and thrombus debulking, lead extraction, venoplasty, and stenting are all important therapeutic interventions. This review provides a multidisciplinary-based approach to the evaluation and management of cardiac implantable electronic device lead-associated venous obstruction.