Publications

2025

Lauder L, Fisher NDL, Böhm M, Pfister O, Secemsky EA, Taub PR, Mahfoud F. Renal Denervation in Hypertension and Chronic Heart Failure.. JACC. Cardiovascular interventions. 2025;18(15):1833–1847. PMID: 40803758

Renal denervation (RDN) is an interventional approach that targets the sympathetic nervous system with the goal of modulating its activity, an important contributor to the pathogenesis of many cardiovascular and metabolic diseases. Unlike pharmacologic therapies, RDN efficacy is independent of patient adherence to medications, which remains a major limiting factor in long-term blood pressure control. Initially developed to treat severe, treatment-resistant hypertension, RDN has demonstrated consistent results in recent sham-controlled trials across the spectrum of hypertension. As a result, RDN has been incorporated into European guidelines as a treatment option for select patients and endorsed by cardiovascular and hypertension societies worldwide. This review outlines the physiological rationale behind RDN, summarizes the current evidence supporting its effectiveness, provides an overview of the available technologies, and evaluates its emerging role in the treatment of chronic heart failure and other conditions characterized by high sympathetic nervous system activity. Finally, the authors explore future directions, including the concept of multiorgan denervation, which aims to achieve an enhanced degree of sympathetic modulation by targeting additional sympathetic nerves beyond the kidney.

Halabi S, Hennawi HA, Secemsky EA, Palena M, Manzi M. Intravascular Ultrasound Guided Puncture of Stumpless Tibial Occlusions.. The American journal of cardiology. 2025; PMID: 40789536

This report describes a novel technique using intravascular ultrasound (IVUS) to guide revascularization of a stumpless posterior tibial artery occlusion in a patient with chronic limb-threatening ischemia. After failed attempts at both antegrade and retrograde access, IVUS was employed to identify and mark the exact location of the posterior tibial artery ostium. Using this guidance, successful wire cannulation was achieved, confirmed intraluminally with IVUS, followed by balloon angioplasty and restoration of brisk in-line flow through the posterior tibial and lateral plantar arteries. This intervention ultimately led to complete wound healing and avoided a major amputation. In conclusion, this IVUS-guided technique offers a safe and effective approach for revascularizing challenging stumpless tibial occlusions, expanding the tools available for limb salvage in complex peripheral artery disease.

Secemsky EA, Sato R, Williams AO, Fanaroff AC, Duval S, Jaff MR, Greenberg-Worisek A, Giri J, Wifler W, Monteleone P. Interplay of Race and Community Characteristics on Health Disparities among Medicare Beneficiaries with Peripheral Artery Disease.. The American journal of cardiology. 2025; PMID: 40784469

BACKGROUND: Research on disparities in peripheral artery disease (PAD) often examines factors individually. However, complex interactions between sex, race, and geography likely influence outcomes and treatment use OBJECTIVE: This study investigates the combined effects of race and community characteristics on outcomes and treatment utilization among Medicare beneficiaries with PAD METHODS: This retrospective cohort study analyzed 100% Medicare Standard Analytic Files from 2017 to 2023. Primary outcomes included death, major amputation, and endovascular and surgical revascularization. Kaplan-Meier and Cox proportional hazards regression were used to examine the associations between outcomes and individual-level race (Black versus White) and county-level minority population percentage (the percentage that was not non-Hispanic White, using the Distressed Community Index).

RESULTS: Black patients had an increased risk of death and major amputation than White patients (death: Hazard Ratio [HR]=1.13, 95% Confidence Interval [CI]=1.12, 1.13; major amputation: HR=2.79, 95% CI=2.72, 2.86). These risks were exacerbated in counties with a higher percentage of minority populations. While Black patients were more likely to receive endovascular revascularization treatment than White patients overall (HR=1.06, 95%CI=1.05, 1.08), those residing in counties in the highest quartile of minority population percentage were significantly less likely to receive endovascular revascularization (HR=0.95, 95% CI=0.94, 0.97) compared to those in the lowest quartile of minority population percentage.

CONCLUSIONS: This study highlights the combined impact of race and community characteristics on health disparities in PAD populations. More access to appropriate interventions among Black patients residing in areas with high-minority populations could significantly improve health outcomes and advance equity.

Kim JM, Li S, Song Y, Parikh SA, Schneider PA, Krishnan P, Yeh RW, Secemsky EA. Geographic Variation in Endovascular Revascularization for Chronic Limb-Threatening Ischemia Care Among Medicare Beneficiaries (2016-2023).. Journal of vascular surgery. 2025; PMID: 40738231

OBJECTIVE: Chronic limb-threatening ischemia (CLTI), the most severe manifestation of peripheral artery disease (PAD), is associated with high risk of major amputation and mortality. While timely revascularization is a cornerstone of CLTI management, disparities in access to care and outcomes persist across US geographic regions. This study aims to evaluate variations in endovascular revascularization for CLTI, healthcare utilization patterns, and outcomes stratified by US regions to inform how we address these disparities.

METHODS: From 2016 through 2023, all endovascular revascularizations for CLTI among Medicare fee-for-service beneficiaries were included and evaluated by Northeast, South, Midwest, and West regions of the US. Follow-up continued through December 31, 2023, with a median duration of 625 days (maximum 2921 days). The primary outcome was a composite of death or major amputation. Secondary outcomes included major amputation, all-cause mortality, repeat revascularization, change in ambulatory status, and healthcare utilization before and after revascularization. Multivariable Cox proportional hazards regression models were used to adjust for demographic, clinical, and procedural characteristics.

RESULTS: Among 381,173 beneficiaries, the South performed more than half of all revascularizations throughout the study period (52.18%), followed by the West (17.3%), Northeast (16.2%), and the Midwest (13.9%). After adjustment, the Midwest showed the highest risk for the primary outcome (hazard ratio [HR] 1.20, 95% confidence interval [CI]: 1.18, 1.22, p<0.0001) followed by the South (HR 1.11, 95% CI 1.10, 1.13, p<0.0001) and West (HR 1.04, 95% CI 1.02, 1.06, p<0.0001), all compared to the Northeast. Healthcare utilization analyses revealed fewer outpatient visits with a vascular provider before and after revascularization in all regions compared to the Northeast with the lowest rates in the Midwest (before revascularization: adjusted rate ratio [aRR]: 0.73; 95% CI: 0.72, 0.74; p<0.0001; after revascularization: aRR: 0.73; 95% CI: 0.72, 0.74; p<0.0001) CONCLUSIONS: Disparities in access to care and outcomes persist across U.S. regions for Medicare beneficiaries with CLTI and influence healthcare utilization and outcomes. The Midwest region in particular, that care for a high proportion of rural patients, experience the greatest risks of amputation and death related to CLTI, which may in part be due to less frequent healthcare contact following revascularization. Targeted improvements in healthcare access, especially in rural and economically disadvantaged regions, are needed to enhance outcomes in CLTI patients.

Lee HH, Sharp ASP, Secemsky EA. Measuring Success in Renal Denervation: Response Parameters and Predictors of Response.. The American journal of cardiology. 2025; PMID: 40684826

Renal denervation has recently emerged as a novel approach to improving blood pressure control, particularly in patients with uncontrolled or resistant hypertension. Although a substantial body of evidence has accumulated regarding the procedure's efficacy and safety, considerable variation exists across studies in the primary measures used to assess treatment response. The degree of response also differs widely among individuals, highlighting the importance of identifying factors associated with enhanced or limited responses to renal denervation. In this review, we summarize the currently available evidence on response parameters and predictors of response to renal denervation and offer perspectives for future research.

Weber MA, Secemsky EA, Krawisz A, Kandzari DE. Renal denervation for managing hypertension: Key elements in selecting and referring patients.. Cardiovascular revascularization medicine : including molecular interventions. 2025; PMID: 40670248

Renal denervation (RDN) is an innovative procedure with regulatory approval for treating patients whose blood pressure remains uncontrolled despite lifestyle changes and the prescription of antihypertensive medications. It is important to consider how to create accessible patient referral pathways for this complementary therapy in the context of differing healthcare systems and the availability of appropriate resources. Today, most hypertensive patients are managed by primary care practitioners in the community. This paper considers various program models that integrate RDN into clinical practice, from decentralized systems where community physicians refer patients to an RDN facility, to centralized hypertension or academic centers that provide comprehensive care. Providing community practices with checklists that guide patient selection for possible referral for RDN is an important start to the process. Key to the success of an RDN program at an interventional facility is the careful selection of patients. Ideally, this is managed by a team that includes interventional physicians skilled in the RDN procedure, clinicians knowledgeable about hypertension management who can confirm the suitability of patients referred for the procedure, and supporting nursing staff to guide patients through the process. By adopting the practices outlined in this paper, the availability of RDN can be appropriately applied to improving hypertension control in patients at need, in turn reducing their risk of adverse cardiovascular outcomes.

Brodmann M, Falah B, Palena LM, Tan KT, Airoldi F, Liistro F, Razavi MK, Parikh SA, Secemsky EA, Granada JF. Clinical and Angiographic Outcomes of a Novel Thin Strut Poly(L-lactide) Based Bioresorbable Vascular Scaffold in Below the Knee Arterial Disease: The RESOLV I First in Human Study.. European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. 2025; PMID: 40651804

OBJECTIVE: This first in human study evaluated the six month angiographic and one year clinical outcomes of a novel thin strut, sirolimus eluting, resorbable scaffold for symptomatic below the knee peripheral arterial disease (PAD). RESOLV I is an international, prospective, multicentre, single arm study assessing the performance of the MAGNITUDE drug eluting resorbable scaffold (DRS) for the treatment of below the knee lesions in patients with symptomatic PAD.

METHODS: Angiographic and duplex ultrasound evaluations were performed by independent core labs at baseline, post-DRS implantation, and at six months follow up. Binary re-stenosis (> 50% diameter stenosis) was determined via quantitative vascular angiography or duplex ultrasound when quantitative vascular angiography was unavailable. Peri-operative death, major adverse limb events, and functional status were evaluated up to one year.

RESULTS: Thirty five patients (mean age 74.5 ± 6.0 years) were enrolled: six (17%) had chronic total occlusion lesions and 25 (71%) had a baseline Rutherford-Becker classification of stage 5. The mean lesion length was 30.1 ± 12.0 mm. The binary re-stenosis rate at six months was 10% (3/31) (angiographic patency of 90%) and mean in segment late lumen loss was 0.75 ± 0.74 mm. Improved Rutherford class at 12 months follow up was achieved in 88% (29/33) of patients and most were asymptomatic (Rutherford-Becker class 0). No amputation or clinically driven target lesion revascularisation events were seen through 12 months.

CONCLUSION: Early results of the RESOLV I study showed that implantation of a thin strut MAGNITUDE DRS achieved low binary re-stenosis rates at six months, as well as improvement in functional status, with no clinically driven target lesion revascularisation at one year.