Publications

2024

Shimoda T, D’Oria M, Kuno T, Heindel P, Lepidi S, Hussain MA, Takagi H, Secemsky EA. Comparative Effectiveness of Intravascular Ultrasound Versus Angiography in Abdominal and Thoracic Endovascular Aortic Repair: Systematic Review and Meta-Analysis.. The American journal of cardiology. 2024;223:81–91. PMID: 38768845

The effectiveness of intravascular ultrasound (IVUS) with angiography compared with angiography guidance alone in treating aortic conditions, such as dissections, aneurysms, and blunt traumatic injuries, remains unclear. This systematic review and meta-analysis evaluates the current literature for IVUS use during thoracic endovascular aortic repair (TEVAR) and abdominal endovascular aortic repair (EVAR). A comprehensive search of MEDLINE, EMBASE, and Cochrane CENTRAL databases was conducted in March 2024 adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies comparing outcomes of TEVAR/EVAR with and without IVUS were identified. The outcomes of interest included contrast volume, fluoroscopy and procedural time, perioperative endoleak, and reinterventions and all-cause mortality during follow-up. Data with 95% confidence intervals (CIs) were extracted. Pooled analysis was performed using a random-effect model. Subgroup analysis was performed stratified by the condition being treated. Risk of bias was assessed using the Newcastle-Ottawa Scale for observational studies. A total of 4,219 patients (n = 2,655 IVUS and n = 1,564 non-IVUS) from 9 observational studies were included. The IVUS group exhibited a reduction in contrast agent volume (weighted mean difference -34.65 mL, 95% CI -54.73 to -14.57) and fluoroscopy time (weighted mean difference -6.13 minutes, 95% CI -11.10 to -1.15), with no difference in procedural time. The perioperative type I and III endoleak occurrences were similar (risk ratio 2.36, 95% CI 0.55 to 10.11; risk ratio 0.72, 95% CI 0.09 to 5.77, respectively). Reintervention and mortality during follow-up were comparable (hazard ratio 0.80, 95% CI 0.33 to 1.97; hazard ratio 0.75, 95% CI 0.47 to 1.18, respectively). All the included studies had small risks of bias. In conclusion, this meta-analysis provides evidence that IVUS enables the safe deployment of TEVAR/EVAR with reduced contrast agent and radiation exposure.

Members WC, Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutierrez A, Hawkins BM, Hess CN, Ho KJ, Jones S, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.. Journal of the American College of Cardiology. 2024;83(24):2497–2604. PMID: 38752899

AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia).

METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate.

STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.

Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutierrez A, Hawkins BM, Hess CN, Ho KJ, Jones S, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.. Circulation. 2024;149(24):e1313-e1410. PMID: 38743805

AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia).

METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate.

STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.

Fanaroff AC, Dayoub EJ, Yang L, Schultz K, Ramadan OI, Wang GJ, Damrauer SM, Genovese EA, Secemsky EA, Parikh SA, Nathan AS, Kohi MP, Weinberg MD, Jaff MR, Groeneveld PW, Giri JS. Association Between Diagnosis-to-Limb Revascularization Time and Clinical Outcomes in Outpatients With Chronic Limb-Threatening Ischemia: Insights From the CLIPPER Cohort.. Journal of the American Heart Association. 2024;13(9):e033898. PMID: 38639376

BACKGROUND: The extent and consequences of ischemia in patients with chronic limb-threatening ischemia (CLTI) may change rapidly, and delays from diagnosis to revascularization may worsen outcomes. We sought to describe the association between time from diagnosis to endovascular lower extremity revascularization (diagnosis-to-limb revascularization [D2L] time) and clinical outcomes in outpatients with CLTI.

METHODS AND RESULTS: In the CLIPPER cohort, comprising patients between 66 and 86 years old diagnosed with CLTI betweeen 2010 and 2019, we used Medicare claims data to identify patients who underwent outpatient endovascular revascularization within 180 days of diagnosis. We described the risk-adjusted association between D2L time and clinical outcomes. Among 1 130 065 patients aged between 66 and 86 years with CLTI, 99 221 (8.8%) underwent outpatient endovascular lower extremity revascularization within 180 days of their CLTI diagnosis. Among patients with D2L time <30 days, there was no association between D2L time and all-cause death or major lower extremity amputation. However, among patients with D2L time >30 days, each additional 10-day increase in D2L time was associated with a 2.5% greater risk of major amputation (hazard ratio, 1.025 [95% CI, 1.014-1.036]). There was no association between D2L time and all-cause death.

CONCLUSIONS: A delay of >30 days from CLTI diagnosis to lower extremity endovascular revascularization was associated with an increased risk of major lower extremity amputation among patients undergoing outpatient endovascular revascularization. Improving systems of care to reduce D2L time could reduce amputations.

Pyun AJ, Goodney PP, Eldrup-Jorgensen J, Wadzinski J, Secemsky EA, Cigarroa JE. Device regulation and surveillance in vascular care: Challenges and opportunities.. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2024;104(1):84–91. PMID: 38639136

Cardiovascular devices are essential for the treatment of cardiovascular diseases including cerebrovascular, coronary, valvular, congenital, peripheral vascular and arrhythmic diseases. The regulation and surveillance of vascular devices in real-world practice, however, presents challenges during each individual product's life cycle. Four examples illustrate recent challenges and questions regarding safety, appropriate use and efficacy arising from FDA approved devices used in real-world practice. We outline potential pathways wherein providers, regulators and payors could potentially provide high-quality cardiovascular care, identify safety signals, ensure equitable device access, and study potential issues with devices in real-world practice.

Wadhera RK, Secemsky EA, Xu J, Yeh RW, Song Y, Goldhaber SZ. Community Socioeconomic Status, Acute Cardiovascular Hospitalizations, and Mortality in Medicare, 2003 to 2019.. Circulation. Cardiovascular quality and outcomes. 2024;17(4):e010090. PMID: 38597091

BACKGROUND: Socioeconomically disadvantaged communities in the United States disproportionately experience poor cardiovascular outcomes. Little is known about how hospitalizations and mortality for acute cardiovascular conditions have changed among Medicare beneficiaries in socioeconomically disadvantaged and nondisadvantaged communities over the past 2 decades.

METHODS: Medicare files were linked with the Centers for Disease Control and Prevention's social vulnerability index to examine age-sex standardized hospitalizations for myocardial infarction, heart failure, ischemic stroke, and pulmonary embolism among Medicare fee-for-service beneficiaries ≥65 years of age residing in socioeconomically disadvantaged communities (highest social vulnerability index quintile nationally) and nondisadvantaged communities (all other quintiles) from 2003 to 2019, as well as risk-adjusted 30-day mortality among hospitalized beneficiaries.

RESULTS: A total of 10 942 483 Medicare beneficiaries ≥65 years of age were hospitalized for myocardial infarction, heart failure, stroke, or pulmonary embolism (mean age, 79.2 [SD, 8.7] years; 53.9% female). Although age-sex standardized myocardial infarction hospitalizations declined in socioeconomically disadvantaged (990-650 per 100 000) and nondisadvantaged communities (950-570 per 100 000) from 2003 to 2019, the gap in hospitalizations between these groups significantly widened (adjusted odds ratio 2003, 1.03 [95% CI, 1.02-1.04]; adjusted odds ratio 2019, 1.14 [95% CI, 1.13-1.16]). There was a similar decline in hospitalizations for heart failure in socioeconomically disadvantaged (2063-1559 per 100 000) and nondisadvantaged communities (1767-1385 per 100 000), as well as for ischemic stroke, but the relative gap did not change for both conditions. In contrast, pulmonary embolism hospitalizations increased in both disadvantaged (146-184 per 100 000) and nondisadvantaged communities (153-184 per 100 000). By 2019, risk-adjusted 30-day mortality was similar between hospitalized beneficiaries from socioeconomically disadvantaged and nondisadvantaged communities for myocardial infarction, heart failure, and ischemic stroke but was higher for pulmonary embolism (odds ratio, 1.10 [95% CI, 1.01-1.20]).

CONCLUSIONS: Over the past 2 decades, hospitalizations for most acute cardiovascular conditions decreased in both socioeconomically disadvantaged and nondisadvantaged communities, although significant disparities remain, while 30-day mortality is now similar across most conditions.

Rodriguez BC, Secemsky EA, Swaminathan R V, Feldman DN, Schlaich M, Battaglia Y, Filippone EJ, Krittanawong C. Opportunities and Limitations of Renal Denervation: Where Do We Stand?. The American journal of medicine. 2024;. PMID: 38588936

Hypertension is a primary contributor to cardiovascular disease, and the leading risk factor for loss of quality adjusted life years. Up to 50% of the cases of hypertension in the United States remain uncontrolled. Additionally, 8%-18% of the hypertensive population have resistant hypertension; uncontrolled pressure despite 3 different antihypertensive agents. Recently, catheter-based percutaneous renal denervation emerged as a method for ablating renal sympathetic nerves for difficult-to-control hypertension. Initial randomized (non-sham) trials and registry analyses showed impressive benefit, but the first sham-controlled randomized controlled trial using monopolar radiofrequency ablation showed limited benefit. With refinement of techniques to include multipolar radiofrequency, ultrasound denervation, and direct ethanol injection, randomized controlled trials demonstrated significant blood pressure improvement, leading to US Food and Drug Administration approval of radiofrequency- and ultrasound-based denervation technologies. In this review article, we summarize the major randomized sham-controlled trials and societal guidelines regarding the efficacy and safety of renal artery denervation for the treatment of uncontrolled hypertension.

Patrone L, Pasqui E, Conte MS, Farber A, Ferraresi R, Menard M, Mills JL, Rundback J, Schneider P, Ysa A, Abhishek K, Adams GL, Ahmad N, Ahmed I, Alexandrescu VA, Amor M, Alper D, Andrassy M, Attinger C, Baadh A, Barakat H, Biasi L, Bisdas T, Bhatti Z, Blessing E, Bonaca MP, Bonvini S, Bosiers M, Bradbury AW, Beasley R, Behrendt CA, Brodmann M, Cabral G, Cancellieri R, Casini A, Chandra V, Chisci E, Chohan O, Choke ETC, Chong PFS, Clerici G, Coscas R, Costantino M, Paola LD, Dand S, Davies RSM, D’Oria M, Diamantopoulos A, Debus S, Deloose K, Del Giudice C, de Donato G, De Rubertis B, De Vries JP, Dias N V, Diaz-Sandoval L, Dick F, Donas K, Dua A, Fanelli F, Fazzini S, Foteh M, Gandini R, Gargiulo M, Garriboli L, Genovese EA, Gifford E, Gouëffic Y, Goverde P, Gupta PC, Hinchliffe R, Holden A, Houlind KC, Howard DP, Huasen B, Isernia G, Katsanos K, Katzen B, Kolh P, Koncar I, Korosoglou G, Krishnan P, Kroencke T, Krokidis M, Kumarasamy A, Hayes P, Iida O, Lafont EA, Langhoff R, Lecis A, Lessne M, Lichaa H, Lichtenberg M, Lobato M, Lopes A, Loreni G, Lucatelli P, Madassery S, Maene L, Manzi M, Maresch M, Mathews JS, McCaslin J, Micari A, Michelagnoli S, Migliara B, Morgan R, Morelli L, Morosetti D, Mouawad N, Moxey P, Müller-Hülsbeck S, Mustapha J, Nakama T, Nasr B, N’dandu Z, Neville R, Noory E, Nordanstig J, Noronen K, Palena LM, Parlani G, Patel AS, Patel P, Patel R, Patel S, Pena C, Perkov D, Portou M, Pratesi G, Rammos C, Reekers J, Riambau V, Roy T, Rosenfield K, Ruffino MA, Saab F, Saratzis A, Sbarzaglia P, Schmidt A, Secemsky E, Siah M, Sillesen H, Simonte G, Sirvent M, Sommerset J, Steiner S, Sakr A, Scheinert D, Shishebor M, Spiliopoulos S, Spinelli A, Stravoulakis K, Taneva G, Teso D, Tessarek J, Theivacumar S, Thomas A, Thomas S, Thulasidasan N, Torsello G, Tripathi R, Troisi N, Tummala S, Tummala V, Twine C, Uberoi R, Ucci A, Valenti D, van den Berg J, van den Heuvel D, Van Herzeele I, Varcoe R, de Ceniga MV, Veith FJ, Venermo M, Vijaynagar B, Virdee S, Von Stempel C, Voûte MT, Yeung KK, Zeller T, Zayed H, Baker MM. The "Woundosome" Concept and Its Impact on Procedural Outcomes in Patients With Chronic Limb-Threatening Ischemia.. Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists. 2024;:15266028241231745. PMID: 38523459
Talasaz AH, Sadeghipour P, Ortega-Paz L, Kakavand H, Aghakouchakzadeh M, Beavers C, Fanikos J, Eikelboom JW, Siegal DM, Monreal M, Jimenez D, Vaduganathan M, Castellucci LA, Cuker A, Barnes GD, Connors JM, Secemsky EA, Van Tassell BW, De Caterina R, Kurlander JE, Aminian A, Piazza G, Goldhaber SZ, Moores L, Middeldorp S, Kirtane AJ, Elkind MS V, Angiolillo DJ, Konstantinides S, Lip GYH, Stone GW, Cushman M, Krumholz HM, Mehran R, Bhatt DL, Bikdeli B. Optimizing antithrombotic therapy in patients with coexisting cardiovascular and gastrointestinal disease.. Nature reviews. Cardiology. 2024;21(8):574–592. PMID: 38509244

Balancing the safety and efficacy of antithrombotic agents in patients with gastrointestinal disorders is challenging because of the potential for interference with the absorption of antithrombotic drugs and for an increased risk of bleeding. In this Review, we address considerations for enteral antithrombotic therapy in patients with cardiovascular disease and gastrointestinal comorbidities. For those with gastrointestinal bleeding (GIB), we summarize a general scheme for risk stratification and clinical evidence on risk reduction approaches, such as limiting the use of concomitant medications that increase the risk of GIB and the potential utility of gastrointestinal protection strategies (such as proton pump inhibitors or histamine type 2 receptor antagonists). Furthermore, we summarize the best available evidence and potential gaps in our knowledge on tailoring antithrombotic therapy in patients with active or recent GIB and in those at high risk of GIB but without active or recent GIB. Finally, we review the recommendations provided by major medical societies, highlighting the crucial role of teamwork and multidisciplinary discussions to customize the antithrombotic regimen in patients with coexisting cardiovascular and gastrointestinal diseases.