Publications

BACKGROUND: The Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial reported the superiority of surgical bypass compared with endovascular intervention for the treatment of chronic limb-threatening ischemia (CLTI) in patients deemed suitable for either; however, the generalizability of these findings to the broader CLTI population is in question. Herein, we analyzed perioperative (30-day) outcomes from the National Surgical Quality Improvement Project (NSQIP) for CLTI interventions.

METHODS: The NSQIP-Vascular targeted database was queried from 2014 to 2019, contemporaneous with BEST-CLI, for patients undergoing CLTI intervention. Surgical bypass groups included saphenous vein (OPEN-GSV) or alternative conduit (OPEN-Other) and were compared to the endovascular (intervention group) (ENDO). Inverse Probability weighting with regression adjustment assessed 30-day outcomes including perioperative death (POD), major amputation, major adverse limb events (MALE, major reintervention and/or amputation), composite MALE or POD, and major adverse cardiovascular events (MACE, myocardial infarction, or stroke). Results were provided as risk ratio (RR).

RESULTS: Of the total cohort, 6780 (34.1%) were in the OPEN-GSV group, 4201 (21.1%) in OPEN-Other, and 8887 (44.7%) in ENDO. Compared to OPEN-GSV, ENDO exhibited a higher risk for major amputation (RR, 1.38; P = .002), higher risk of MALE (RR, 1.23; P = .004), lower risk of MACE (RR, 0.48; P < .001), and similar risk for all other outcomes. Compared to OPEN-Other, ENDO exhibited a lower risk of MACE (RR, 0.49; P < .001) and POD (RR, 0.76; P = .040) and was similar for all other outcomes.

CONCLUSIONS: These data demonstrate a higher rate of early amputation and MALE among those who underwent ENDO vs OPEN-GSV. Conversely, early limb events were similar between ENDO and OPEN-Other. Both OPEN-GSV and OPEN-Other were associated with a higher risk of 30-day MACE. OPEN-Other was associated with a higher risk of MACE. These data highlight the importance of patient selection to optimize overall patient outcomes in CLTI.

Pulmonary embolism (PE) is a life-threatening condition characterised by occlusion of the pulmonary vasculature, with a global incidence of approximately 1 in 1,000 patients. While pharmacological therapy remains the cornerstone of PE management, selected patients may benefit from catheter-directed treatments due to their potential for rapid symptom relief and swift haemodynamic stabilisation. Catheter-directed thrombolysis and catheter-directed mechanical thrombectomy are current treatment options, though their availability is still limited. This review provides a practical outlook on catheter-directed therapies for PE, outlining optimal procedural planning, device selection, technical execution, evaluation of results, and management of complications.

Endovascular operators experience elevated rates of occupational orthopedic injuries and persistent radiation exposure with current lead shielding. Novel shielding systems eliminate the need to wear lead aprons while also mitigating occupational radiation exposure, but real-world evidence of their efficacy remains needed. This study evaluated consecutive endovascular procedures requiring fluoroscopy at U.S. and international institutions following installation of a commercially available portable shielding system consisting of interlocking radiation-attenuating acrylic and soft shielding components. Live dosimeters were placed at the left shoulder of the main and assistant operators for quantification of radiation exposure. In total, 1,712 endovascular procedures performed by 671 operators at 153 sites (19% non-U.S.). In 1,712 (99.4%), radiation exposure was recorded. A majority of procedures (83.6%) were coronary interventions including diagnostic angiography (43.8%), nonchronic total occlusion PCI (27.6%), and chronic total occlusion PCI (6.7%). Median fluoroscopy time was 7.7 mins (IQR 3.9 to 15.3 min), and median radiation exposure to the main operator and first assistant was 2 μSv and 1 μSv. This was comparable to historical measurements of under-lead radiation exposure. In conclusion, the Rampart system effectively reduced radiation exposure in real-world practice, enabling a safe lead-free procedure lab.

Endovascular renal denervation (RDN) is a catheter-based, procedural therapy for the treatment of hypertension that was approved by the US Food and Drug Administration (FDA) in November 2023. Early studies suggest that endovascular RDN reduces blood pressure (BP) in patients with hypertension. However, BP response to RDN is highly variable, optimal patient selection remains uncertain, and the procedure's high cost remains a significant challenge. The purpose of this review is to comprehensively examine the literature regarding the mechanism by which endovascular RDN reduces BP and the safety and effectiveness of RDN, and to discuss key considerations for selecting appropriate patients for endovascular RDN. Relevant studies in the field were identified from PubMed using search terms including 'renal denervation' and 'renal denervation for hypertension.' In conclusion, clinical trials have demonstrated a statistically significant BP-lowering effect of endovascular RDN, which based on multiple trials with long-term follow-up, appears to persist over several years with low complication rates. More research is needed to understand which patients benefit most from endovascular RDN and to evaluate the long-term outcomes, including the impact of endovascular RDN on cardiovascular events.

BACKGROUND: Symptomatic peripheral artery disease (PAD) is prevalent and guideline-recommended therapies include optimal medical therapy (OMT), supervised exercise therapy (SET), and revascularization (stenting). The Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) trial examined longitudinal patient-reported outcomes to assess response to OMT, SET, and stenting. The predictors of symptomatic improvement have not been fully assessed.

METHODS: This is a secondary analysis of the CLEVER trial, which randomized patients with claudication to OMT alone, OMT plus SET, or OMT plus stenting. The primary outcome was a change in the Peripheral Artery Questionnaire (PAQ) summary score by 10 points or more from baseline to 6 and 18 months. Multivariate logistic regression was used to identify predictors of response.

RESULTS: Of the 103 participants (66 men, median age 63 years), 65 (63%) had a response to therapy at 6 months. Of 98 participants who completed the 18-month PAQ, 52 (53%) had a symptomatic response. On binary logistic regression, when compared to OMT, SET (6 months: odds ratio [OR] 4.25, 95% CI: 1.33-13.58; 18 months: OR 3.92, 95% CI: 1.04-14.70) and ST (6 months: OR 5.19, 95% CI: 1.58-17.03; 18 months: OR 11.50, 95% CI: 2.89-45.72) were associated with an increase in PAQ at 6 and 18 months.

CONCLUSION: Among randomized patients in the CLEVER trial, treatment with either SET or stenting was predictive of clinically meaningful change in the PAQ summary score from baseline to 6 and 18 months. These interventions, with a prioritization of SET, should be more widely available to patients with PAD. This study adds to the findings of the CLEVER trial by denoting that SET and stenting are beneficial in patients with PAD, independent of comorbidities.

BACKGROUND: Patients with both peripheral artery disease (PAD) and coronary artery disease are at heightened risk for adverse cardiovascular outcomes. Although long-term risk has been well documented, contemporary in-hospital outcomes for patients with PAD presenting with acute myocardial infarction (AMI) are less well characterized.

METHODS: We analyzed 493 740 AMI hospitalizations from 670 US sites in the NCDR (National Cardiovascular Data Registry) Chest Pain-MI Registry between January 2019 and March 2023. Primary outcomes were in-hospital mortality and major bleeding; secondary end points included cardiac arrest, cardiogenic shock, heart failure, stroke, and new dialysis initiation. Subgroup analyses were conducted by age, sex, race, AMI type, revascularization status, and extent of coronary disease. We used the NCDR validated risk model for multivariable adjustment.

RESULTS: PAD was present in 36 274 patients with AMI (7.4%). In-hospital mortality was significantly higher in patients with PAD compared with those without (8.23% versus 4.87%; adjusted odds ratio [aOR], 1.25 [95% CI, 1.19-1.31]). Increased mortality persisted across age groups (<65 years: aOR, 1.42; ≥65 years: aOR, 1.18) and AMI type (non-ST-segment-elevation MI: aOR, 1.14; ST-segment-elevation MI: aOR, 1.46), with significant interactions by both age and AMI type. Among revascularized patients, mortality was elevated in those with PAD (aOR, 1.49). PAD was associated with increased rates of major bleeding (aOR, 1.23), particularly among revascularized patients (aOR, 1.31), as well as cardiac arrest, shock, heart failure, stroke, and new dialysis.

CONCLUSIONS: PAD was independently associated with markedly worse in-hospital outcomes in AMI, highlighting the need for risk mitigation strategies in this high-risk population.

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.