Publications by Year: 2025

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.

BACKGROUND AND AIMS: Radial access site for percutaneous coronary intervention (PCI) is recommended by clinical practice guidelines because of superior outcomes compared with femoral access site. Historically, the adoption of radial access site in the USA has lagged behind much of the rest of the world, but contemporary data on access site selection across the spectrum of clinical presentations and its association with outcomes are lacking.

METHODS: A retrospective cohort study from the National Cardiovascular Data Registry's CathPCI Registry was conducted including PCIs performed between 1 January 2013 and 30 June 2022. The comparative safety of radial vs femoral access site for PCI was evaluated with instrumental variable analysis, a technique that can be used to support causal inference, exploiting operator variation in access site preferences as the instrumental variable.

RESULTS: Overall, 6 658 479 PCI procedures were performed during the study period, of which 40.4% (n = 2 690 355) were performed via radial access site, increasing from 20.3% in 2013 to 57.5% in 2022. This increase was seen in all geographic regions and across the full spectrum of presentations, with the largest relative increase seen in patients with ST-elevation myocardial infarction. Overall, 2 420 805 PCIs met inclusion criteria for the comparative safety analysis. In instrumental variable analyses, radial access site was associated with lower in-hospital mortality [absolute risk difference (ARD) -.15%, 95% confidence interval (CI) -.20 to -.10], major access site bleeding (ARD -.64%, 95% CI -.68 to -.60), and other major vascular complications (ARD -.21%, 95% CI -.23 to -.18) but a higher risk of ischaemic stroke (ARD .05%, 95% CI .03-.08). There was no association with the falsification endpoint of gastrointestinal or genitourinary bleeding (ARD .00%, 95% CI -.03-.03).

CONCLUSIONS: Over the past decade, use of radial access site for PCI has increased 2.8-fold in the USA and now represents the dominant form of access site across all procedural indications. Based on instrumental variable analyses, PCI with radial access site had lower rates of in-hospital mortality, major access site bleeding, and other major vascular complications compared with femoral access site but a slightly higher risk of ischaemic stroke in contemporary practice.

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.

INTRODUCTION: National guidelines recommend forearm arteriovenous fistulas (AVFs) over upper arm AVFs as the initial permanent vascular access for hemodialysis if consistent with the end-stage kidney disease (ESKD) Life-Plan, but comparative outcomes are underexplored. Our objective was to assess longitudinal outcomes of forearm versus upper arm AVFs in patients with advanced kidney disease.

METHODS: Using multicenter data from three prospective studies (Hemodialysis Fistula Maturation [HFM] Study; PATENCY-1; and PATENCY-2), we conducted a cohort study of 1,516 patients who underwent upper extremity AVF creation (2014-2019). Demographic factors, comorbidities, procedural details, and 3 years of longitudinal follow-up were captured. Outcomes included primary, primary-assisted, and secondary patency at 3 years, successful AVF use, and access-related hand ischemia (ARHI) interventions. Forearm versus upper arm AVF outcomes were compared using Cox regression and logistic regression models. Subgroup analyses included outcomes stratified by site volume using model interaction terms.

RESULTS: The study population included 1,059 forearm AVFs and 457 upper arm AVFs; mean (SD) age was 56.2 (13.4) years and 25.2% were female. The overall primary, primary-assisted, and secondary patency at 3 years was 26.2% (95% CI 23.6% to 29.1%), 57.6% (54.6% to 60.9%), and 66.5% (63.6% to 69.5%), respectively, with no significant differences between forearm and upper arm AVFs. Successful AVF use at 12 months was also similar between forearm (66.1%) and upper arm AVFs (70.0%) (OR 1.02, 95% CI [0.71-1.48], p=0.91). Forearm AVFs had lower risk of ARHI interventions (HR 0.36, 95% CI [0.18-0.71], p=0.003) compared to upper arm AVFs. Subgroup analyses showed that compared to upper arm AVFs, patients who received forearm AVFs at low volume sites (≤30 access creations per year) were at higher risk for loss of primary-assisted (HR 2.03, 95% CI [1.21-3.41], p<0.001) and secondary patency (HR 2.53, 95% CI [1.33-4.83], p <0.001). Patients receiving forearm AVFs at low volume sites also had lower AVF use at 12 months (OR 0.52, 95% CI [0.21-1.31], p value of interaction =0.03).

CONCLUSIONS: Although forearm AVFs demonstrate similar long-term patency and usability to upper arm AVFs, they are associated with lower rates of ARHI. However, outcomes for forearm AVFs appear to have associations with institutional volume-significantly poorer results are seen at low-volume centers. System-level efforts are needed to improve outcomes for forearm AVFs, which serve as a critical lifeline for ESKD patients.