Patel, Parag

Introduction: The use of intravascular ultrasound (IVUS) to guide lower extremity deep venous stent placement is associated with improved identification of the degree of maximal vessel stenosis, vessel obstruction, and thrombus burden, compared to venography alone. As the US medical system moves towards value-based care, the financial impact of interventional tools requires close consideration. Currently, there are limited evaluations of the cost effectiveness of IVUS during venous procedures. Research Question: This study seeks to examine the cost-effectiveness of IVUS in lower extremity deep venous interventions. Methods: Medicare fee-for-service claims data from 2016 through 2021 for beneficiaries aged ≥ 65 years undergoing lower extremity venous interventions with stent placement, thrombolysis, and/or thrombectomy were analyzed. Cost ratios between IVUS-guided and non-IVUS-guided procedures were assessed using gamma regression, adjusting for demographic and clinical variables. Results: A total of 52,610 patients were included, with 42.6% undergoing IVUS-guided procedures. IVUS utilization varied by setting, with higher usage in hospital-based outpatient centers (75.3%) and ambulatory surgical centers/outpatient-based laboratories (ASC/OBL; 86.4%) compared to inpatient hospitalizations (10.4%). Among inpatient procedures, IVUS-guided venous intervention was associated with greater cost than non-IVUS procedures at 90 days, with an adjusted cost ratio of 1.04 (95% CI 1.01-1.07), yet was associated with an average 0.6-day shorter hospitalization (p < 0.001; Figure 1, Figure 2 ). There were marginal increased costs associated with use of IVUS in inpatient procedures persisting through one- and three-years follow-up, with adjusted cost ratios of 1.05 (95% CI 1.02-1.08) and 1.05 (95% CI 1.02-1.09), respectively. In contrast, IVUS use was associated with significant cost savings in outpatient settings, with adjusted cost ratios of 0.71 (95% CI 0.69-0.73) in hospital-based outpatient settings and 0.75 (95% CI 0.73-0.78) in ASC/OBL at 90 days. These cost savings persisted at one- and three-year follow-up. Conclusions: IVUS-guided venous intervention was associated with cost savings in outpatient and ASC/OBL settings, while maintaining near cost equivalence in inpatient settings. These findings suggest that in addition to the clinical benefit of IVUS for venous intervention, IVUS is a cost-effective strategy, particularly in the outpatient setting.

Background: Impella 5.5 is a temporary MCS device FDA-approved for use up to 14 days. Limited data suggest it may be safe beyond this. We aim assess outcomes based on the duration of Impella 5.5 support in heart failure cardiogenic shock (HFCS) patients at our institution. Methods: We retrospectively reviewed all HFCS patients supported with Impella 5.5 at our institution between 2020-2024. Patients supported for >14 days were compared with those supported for ≤14 days. Categorical variables were analyzed with chi-square tests, continuous variables with t-tests or Mann-Whitney U. Logistic regression identified factors linked to clinical outcomes. Results: 154 patients were included: 38 (25%) with support ≤14 days, 116 (75%) with >14 days. Median support duration was 10 (6–12) vs 31 (22–45) days, respectively. Median support duration was 10 (6-12) days for the ≤14 cohort and 31 days (22-45) days for the >14 cohort. Baseline characteristics, comorbidities, LVEF 18% (15-23) and hemodynamics show no statistical differences. Patients supported for >14 days were more likely to undergo heart transplant compared to those supported ≤14 days (91% vs 74%, p=0.009). In contrast, myocardial recovery was more likely in the ≤14 day cohort (8% vs 1%, p=0.018). One patient suffered stroke post-transplant in the ≤14 day group and two had brachial plexus injuries in the >14 days group. Mortality during the impella-supported period was slightly higher in the ≤14 day group (8% vs 5%, p=0.535) but comparable overall, 13% in both groups, p=0.971. Support >14 days was associated with transplant outcome (OR 3.41, 95% CI 1.32–8.84, p=0.012), and remained significant after adjusting for age, gender, GFR, and EF (OR 4.05, 95% CI 1.31–12.54, p=0.015). Support duration <14 days was associated with recovery or LVAD outcomes (OR 5.01, 95% CI 1.49–16.89, p=0.009), and remained significant after adjustment (OR 5.43, 95% CI 1.11–26.45, p=0.036). No association was observed between duration of support and LVAD/mortality outcomes or with EcPella use. Conclusion: Shorter Impella support duration was independently associated with early myocardial recovery or LVAD candidacy, likely reflecting rapid clinical decision-making. Prolonged Impella support was associated with increased likelihood of transitioning to heart transplantation, likely reflecting clinical stabilization over time. Our multidisciplinary, single-center data suggests Impella 5.5 can be used beyond FDA-approved 14 days in HFCS patients.

Abstract Background Patients with end-stage heart failure and chronic kidney disease requiring dual-organ transplantation (DOT) face significant challenges in utilizing durable mechanical circulatory support due to the risks associated with renal replacement therapies (RRTs) and multi-organ failure. Given the limited options available for long-term support in this patient population, there remains a critical need for alternative strategies to optimize end-organ function and bridge patients safely to transplant. With prolonged waitlist times for DOT, we present our experience with the Impella 5.5 as temporary mechanical circulatory support, demonstrating its potential to provide hemodynamic stability and support as a bridge to transplantation (BTT) in this complex cohort. Methods A single-centre retrospective review was completed of all patients listed for single-organ transplantation or DOT between December 2019 and November 2022 at Mayo Clinic in Florida, supported by the Impella 5.5 intended as BTT. The focus of this analysis was patients requiring RRT or listed for heart/kidney transplantation. Data were extracted from the electronic health record at baseline and during their transplant episode of care after institutional review board approval as exempt status for retrospective data collection. Results A total of 41 patients were supported with Impella 5.5, intended as BTT. All patients underwent successful transplantation. We focus on the 10 patients with Impella support who underwent DOT. In the DOT group, the median age at transplantation was 63 years (59–66), with nine males and one female. The baseline median ejection fraction was 19% (15–22), with 50% Caucasian and 50% African American and an even split between ischaemic and non-ischaemic aetiology. Median body mass index was 30 kg/m2 (26–31), and 60% were in blood group O. The median time on the waitlist for DOT patients was 53 days (29–75). Perioperative management of DOT Impella patients demonstrated baseline haemodynamics of RA 11 mmHg (7–16), mean PA 36 mmHg (32–47), PCWP 29 mmHg (21–35), mixed venous saturation (SVO2%) 51 (46–61) and Fick CI 2.03 L/min/m2 (1.66–2.5). Post-Impella placement haemodynamics demonstrated significant improvements in RA pressure to 5 mmHg (4–8), P = 0.02, SVO2 to 70% (65–72), P = 0.002, and Fick CI to 5.5 (5.2–8), P = 0.03. The average duration of support was 44 days (range 10–94). The median glomerular filtration rate at baseline was 27 mmol/L (16–29). Twenty-four hour urine protein averaged 168 mg/24 h (range 87–328), with the 24 h creatinine clearance of 29 mg/24 h (range 24–35). Eight of the 10 patients required continuous or intermittent RRT before DOT. The median total duration of RRT (including Impella support) was 36 days (9–72). DOT recipients had a 1 year survival of 90%, with an average follow-up of 432 days. Conclusions Our findings demonstrate that prolonged use of the Impella 5.5 provides safe and effective haemodynamic support for patients with end-stage heart and kidney failure awaiting dual-organ transplantation. With a 1 year survival rate of 90%, our data suggest that Impella 5.5 can be a viable alternative to traditional support strategies, particularly in patients who are otherwise limited by RRTs. As dual-organ transplantation becomes more prevalent, the Impella 5.5 offers a promising bridge to transplant, improving both short-term and long-term outcomes in this complex patient population.

Introduction/Background: Patients with heart failure and those waiting for a heart transplant often experience a significant decrease in their ability to perform daily activities and exercise, leading to a lower quality of life. Although exercise-based cardiac rehabilitation (EBCR) is a possible treatment option, its effectiveness has not been well measured, resulting in limited adoption. Research Questions/Hypothesis: Could physical rehabilitation before receiving a heart transplant improve functional status and better outcomes? Goals/Aims: Our objective is to evaluate the effect of pre-transplant physical therapy on the standardized improvement of AM-PAC scores, measured from the earliest pre-transplant assessment to the most recent pre-transplant evaluation. Our second objective is to assess the impact of the latest Pre-Transplant AM-PAC Score on the number of hospital-free days following transplantation. Methods: We conducted a retrospective study on 91 heart transplant patients who received Impella support from January 2019 to April 2023, approved by the Mayo Clinic Institutional Review Board. We collected data on demographics, AMPAC scores, and outcomes at three time points. Continuous variables were compared using the T-test or Mann-Whitney test, and categorical variables using the Chi-square or Fisher's exact test. We used a linear regression model to investigate the relationship between rehabilitation duration and AMPAC scores. Quantile regression was preferred due to the non-normal distribution of the outcome, hospital-free days. Results: We conducted a linear regression analysis and found a statistically significant association between increased hours spent in PT and greater improvement. After one hour of physical therapy, there was an average increase of 1.07 (95% CI 0.1, 2; p=0.03) in AMPAC scoore. We also compared the change in the AMPAC score with hospital-free days, and it was statistically significant in quantile regression analysis, indicating an increase of 0.28 (95% CI 0.2, 0.55; P=0.03) points in the AMPAC Score, corresponding to an additional hospital-free day. Conclusion: Increased hours spent in physical therapy show a significant positive association with greater improvement in standardized AM-PAC Mobility scores and hospital-free days. These findings encourage increasing uptake and support of cardiac rehabilitation programs.

Abstract Background Impella is an advanced ventricular assist device frequently used as a bridge to heart transplantation. The association of Impella with increased rates of gout flares has not been studied. Our primary aim is to determine the rates of gout flares in patients on Impella support. Methodology A retrospective study was conducted between January 2017 and September 2022 involving all patients who underwent heart transplantation. The cohort was divided into groups based on Impella support for statistical analysis. In patients receiving Impella support, outcome measures were compared based on the development of gout flares. Results 213 patients were analyzed, with 19.71% supported by Impella. Impella and non-Impella groups had similar age, race, and BMI, but more males were in the Impella group. Gout and chronic kidney disease were more prevalent in Impella-supported patients, while coronary artery disease was less common. The incidence of gout flare was significantly higher in Impella patients (31% vs. 5.3%). The Impella group had an adjusted odds ratio for in-hospital gout flare of 8.069 (95% CI = 2.13–35.08, P = 0.003). Impella-supported patients with gout flares had longer intensive care unit and hospital stays but no difference in mortality or other outcomes. Conclusion Our study is the first to identify the potential association between Impella support and increased rates of gout flares in hospitalized patients. Future studies are required to confirm this association and further elucidate the biological pathways. It is imperative to consider introducing appropriate measures to prevent and promptly manage gout flares in Impella-supported patients.