Publications

BACKGROUND: Despite improving abdominal aortic aneurysm (AAA) outcomes in the United States, significant disparities exist. Smaller studies found that women experienced worse outcomes after endovascular aortic aneurysm repair (EVAR), yet few larger analyses have confirmed this. This study aimed to characterize sex-related differences in outcomes among patients who underwent infrarenal EVAR.

METHODS: Medicare fee-for-service beneficiaries ⩾ 66 years old who underwent infrarenal EVAR for intact AAA between January 1, 2011 and December 31, 2019 were included in this retrospective cohort study. The primary outcome was a composite of late aneurysm rupture, aortic reintervention, conversion to open repair, or all-cause mortality. Cox regression and Fine-Gray models were used.

RESULTS: Among 111,381 patients, the mean age was 76.63 ± 6.60 years, 92.88% were White, and 21.19% were women. The maximum follow-up was 3283 days. The hazard of the primary outcome was higher in women in the adjusted model (p = 0.013). When mortality was excluded, the association with sex persisted (p < 0.0010 [adjusted subdistribution model]; p < 0.0010 [adjusted cause-specific model]). Women experienced a lower frequency of postprocedural office visits, but a higher frequency of emergency department visits and hospital readmissions.

CONCLUSION: Women undergoing EVAR had a greater risk of adverse outcomes and unexpected healthcare utilization. Further investigation is warranted to determine the drivers of these outcomes.

Background: Angiography-derived fractional flow reserve (Angio-FFR) is an emerging tool for guiding percutaneous coronary intervention (PCI). Its uptake and outcomes compared to pressure wire (PW)-based assessment in the US are unknown. Methods: We conducted a cohort study of US Medicare beneficiary data from 1 January 2019 to 31 December 2024. Propensity score matching (1:3) of Angio-FFR to PW was performed in patients who underwent PCI during the same procedure, and separately among those who did not undergo PCI during the same procedure. The primary outcome was the cumulative incidence of major adverse cardiovascular events (MACE) through 2 years, including all-cause death, myocardial infarction (MI) and repeat revascularization. Secondary outcomes included individual MACE components, 30-day acute kidney injury and 30-day major bleeding. Falsification endpoints (hospitalization for pneumonia and hip fracture) were used to assess unmeasured confounding. Results: Of 466,535 angiograms that included intra-procedural physiologic assessment, 1.00% (N=4,672) used Angio-FFR. Annual use increased from 0.47% in 2019 to 3.85% in 2024. Among PCI patients, 1,591 Angio-FFR and 4,773 PW matched PCI patients had similar MACE rates through 2 years (24.8% vs 23.5%; HR 1.01, 95% CI 0.85 - 1.20). Secondary outcomes and falsification endpoints were not significantly different. In non-PCI patients, 2,532 Angio-FFR and 7,596 PW matched patients also had similar MACE through 2 years (24.1% vs 23.9%; HR 0.97, 95% CI 0.84 - 1.11). Conclusions: Angio-FFR usage in the US is modest but increasing. Angio-FFR guidance during angiography versus PW was associated with comparable outcomes through 2 years.

BACKGROUND: The safety and effectiveness of concomitant catheter ablation at the time of left atrial appendage (LAA) occlusion (LAAO) are not well characterized.

OBJECTIVE: This study aimed to describe the safety and effectiveness of LAAO during concomitant ablation of atrial fibrillation (AF) with LAAO performed as a stand-alone procedure.

METHODS: Patients from the Surveillance Postapproval Analysis Plan who underwent concomitant ablation and LAAO were compared with patients who underwent LAAO alone. The primary effectiveness end point was complete seal of the LAA, and the primary safety end point was the occurrence of major adverse events at 45 days.

RESULTS: Among 96,968 patients, 1.9% (n = 1844) underwent concomitant ablation; these patients were younger (median 73 [quartile 1, quartile 3 68-78] vs 76 [72-82] years) and had lower CHA2DS2-VASc scores (4 [3-5] vs 5 [4-6]), previous clinically relevant bleeding (32.4% vs 56.6%), or fall risk (30.2% vs 42.2%). The most common discharge drug therapy in the concomitant AF ablation group was direct-acting oral anticoagulant plus aspirin (56.2%), followed by direct-acting oral anticoagulant alone (30.0%). Immediately after implant, patients undergoing concomitant ablation had lower rates of any residual leak (1.6% vs 3.7%; P < .001); no difference was seen at 45 days (15.7% vs 16.9%; P = .29). In-hospital major adverse events were more frequent in those undergoing LAAO with concomitant ablation than LAAO without ablation (1.9% vs 1.2%; P = .0111). In-hospital major bleeding (1.6% vs 1.0%; P = .0073) and pericardial effusion requiring intervention (0.8% vs 0.4%; P = .0108) were more frequent with combined LAAO and AF ablation. At 1 year after the procedure, the composite of all-cause mortality, stroke, or systemic embolism was less frequent in those undergoing LAAO with concomitant ablation (5.2% vs 9.3%; P < .0001).

CONCLUSION: Patients undergoing concomitant AF ablation at the time of LAAO are younger and have fewer comorbidities. There was no clinically important difference in LAA seal peridevice leaks with concomitant LAAO; however, there was a higher rate of major bleeding and pericardial effusion requiring intervention.

BACKGROUND: Assessing intermediate coronary lesions with an intracoronary pressure wire improves clinical outcomes in patients undergoing cardiac catheterization and percutaneous coronary intervention (PCI). However, clinical use of pressure-wire-based physiological assessment remains low. Measurement of fractional flow reserve (FFR) derived from coronary angiographic images alone correlates well with pressure-wire-based FFR measurements and may simplify procedures, but its effect on clinical outcomes is unknown.

METHODS: In this international noninferiority trial, we randomly assigned patients undergoing coronary angiography who were found to have at least one intermediate coronary stenosis to physiological assessment with measurements derived from angiographic images (FFRangio) or with pressure-wire-based measurements. The primary end point was a composite of death, myocardial infarction, or unplanned, clinically indicated coronary revascularization at 1 year. The noninferiority margin was 3.5 percentage points.

RESULTS: A total of 1930 patients were randomly assigned to physiological assessment with FFRangio (FFRangio group; 965 patients) or a pressure-wire-based approach (pressure-wire group; 965 patients). The mean age of the patients was 68.4 years, and 25.0% of the patients were women. At 1 year, a primary end-point event had occurred in 64 patients (Kaplan-Meier estimate, 6.9%) in the FFRangio group and 65 patients (Kaplan-Meier estimate, 7.1%) in the pressure-wire group (hazard ratio, 0.98; 95% confidence interval, 0.70 to 1.39; difference, -0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval, 2.1 percentage points; P<0.001 for noninferiority). There were no apparent differences between the groups with respect to the incidence of bleeding, acute kidney injury, or procedure-related adverse events.

CONCLUSIONS: Among patients with intermediate coronary-artery lesions undergoing physiological assessment in the cardiac catheterization laboratory, an angiography-guided strategy involving FFRangio was noninferior to a pressure-wire-guided strategy with respect to a composite end point of death, myocardial infarction, or unplanned clinically indicated coronary revascularization at 1 year. (Funded by CathWorks; ALL-RISE ClinicalTrials.gov number, NCT05893498.).

The optimal treatment of patients with diffuse large B-cell lymphoma (DLBCL) or Hodgkin lymphoma (HL) with preexisting cardiomyopathy is uncertain. An anonymous, electronic survey was distributed by e-mail to three US lymphoma cooperative groups, two community hospitals, and twelve academic medical systems, and distributed at one international lymphoma meeting. Fifty hematology-oncology providers caring for patients with lymphoma were included. In response to a vignette of a 67-yo with Stage III DLBCL with LVEF of 40-45%, 15 (30%) would use non-anthracycline regimens, 13 (26%) R-CHOP with liposomal doxorubicin instead of doxorubicin, 11 (22%) R-CHOP without modification and 6 (12%) R-CHOP with a continuous doxorubicin infusion. In a second vignette of a patient with HL in remission after frontline treatment with doxorubicin cumulative dose 300 mg/m2, 16 (32%) would order an echocardiogram after treatment. There was substantial variability in preferred treatment regimens with preexisting cardiomyopathy and in cardiac monitoring after anthracycline.

BACKGROUND: A predictive model for early-stage classic Hodgkin's lymphoma (cHL) does not exist. Leveraging patient-level data from large clinical trials and registries, we developed and validated a model that we term the Early-Stage cHL International Prognostication Index (E-HIPI) to predict 2-year progression-free survival (PFS).

METHODS: We developed the model using the Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) guidelines in 3000 adults with newly diagnosed early-stage cHL from four international phase III clinical trials conducted from 1994 to 2011. External validation was performed in two cohorts, totaling 2360 treated patients from five international cHL registries (1996 to 2019). Two-year PFS was estimated using a Cox model with pretreatment variables selected using backward elimination. Internal validation corrected for overfitting. External validation assessed discrimination and calibration. The final model was also compared against European Organisation for Research and Treatment of Cancer (EORTC) favorable or unfavorable status.

RESULTS: The median age in the development cohort was 31.2 years; 77.4% had stage II disease. The estimated 2-year PFS was 93.7%. Final variables retained in the model were sex and continuous values of maximum tumor diameter (MTD), and levels of hemoglobin and albumin. The optimism-corrected C statistic in the development cohort was 0.63 (95% confidence interval, 0.60 to 0.69). Two-year PFS was lower in the validation cohorts 1 (90.3%) and 2 (91.6%). In validation cohort 1, the C statistic was 0.63 and the calibration slope was near 1, but overall calibration indicated underprediction, which improved on updating the intercept. The performance was similar in validation cohort 2. In addition, higher-risk E-HIPI scores were associated with worse outcomes in both the EORTC unfavorable and favorable subgroups. When included altogether in one Cox model, the E-HIPI was associated with PFS, whereas EORTC favorable or unfavorable status was not. Online risk calculators were developed (https://rtools.mayo.edu/holistic_ehipi/).

CONCLUSIONS: Utilizing objective, continuous, and readily available variables, we developed and validated a new prediction model for early-stage cHL. Male sex, lower hemoglobin or albumin levels, and higher MTDs were associated with worse PFS. (Funded by the National Cancer Institute; grant number, NCI R01 CA 262265-04.).

Anthracyclines are an effective treatment for hematologic malignancies but have significant risk of cardiotoxicity that increases with lifetime dose, best characterized for doxorubicin. However, patients may receive different anthracycline formulations, and cardiotoxic dose equivalency for nondoxorubicin anthracyclines is uncertain, making it challenging to calculate a patient's lifetime dose to make decisions about safety of additional anthracycline treatment and risk stratification for monitoring and cardioprotective strategies. In addition, dexrazoxane reduces the risk of cardiovascular toxicity with anthracyclines but how to incorporate previous dexrazoxane treatment into risk stratification is unclear. Here, a young woman previously treated with anthracyclines as induction therapy for acute myeloid leukemia and concern for previous anthracycline cardiotoxicity presented with disease relapse. Because optimal therapy included retreatment with anthracyclines, this case demonstrates the multidisciplinary discussion for her case, reviewing the risks and benefits of repeat anthracycline exposure and detailing the evidence for strategies to monitor and prevent worsening cardiotoxicity.