First Coast Cardiovascular Institute

Objective: The objective of this open-label, interventional, prospective clinical study was to evaluate the effectiveness of a multimodal wound matrix (MWM) in moving chronic, nonhealing wounds that had failed prior therapies onto a healing trajectory. The overall response rate was the proportion of subjects who had greater than 40% reduction in size after 4 weeks of treatment. Secondary objectives included the percentage area reduction (PAR) after 4 and 12 weeks, incidence of ulcer closing, and changes in quality of life. Approach: An open-label, interventional, prospective cohort, real-world evidence study was conducted following the STROBE criteria. Criteria included chronic nonhealing wounds of multiple etiologies in subjects with extensive comorbidities. Results were compared with data from the U.S. Wound Registry. Results: A total of 111 subjects entered the screening phase and 64 were treated. Fifty-three wounds were eligible for the dataset that included 18 diabetic foot ulcers, 19 venous leg ulcers, 2 pressure injuries, 1 surgical, 1 lower extremity wound, and 12 unclassified etiologies. The objective response rate was 42%. The 4-week PAR was 34%. The 12-week PAR was 66%. Eighteen wounds closed by week 12. Innovation: MWM is a formulation technology developed to address the major obstacles that prevent healing. Results were evaluated in a patient population with extensive comorbidities that had failed prior treatments and would be generally excluded from controlled trials. Conclusion: The results from this study support the contention that MWM achieves substantial clinical improvement in a complex patient population not enrolled in clinical trials and demonstrates an advancement in wound management.

Atherectomy is an important option for debulking atherosclerotic plaque from diseased arteries in patients with infrainguinal arterial disease. Laser atherectomy uses a high-powered laser to remove the plaque from the arteries to restore blood flow. The Pathfinder multicenter registry was initiated to evaluate the safety and efficacy of the 355 nm laser atherectomy system in a real-world setting for the treatment of de novo, re-stenotic and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with peripheral artery disease (PAD). The study was a prospective, single-arm, multicenter, open-label registry study for patients treated with the 355 nm laser system. Clinical and lesion characteristics, procedural safety and efficacy data, and baseline, 6-, and 12-month outcomes data, including Ankle Brachial Index (ABI), Rutherford class, and Walking Impairment Questionnaires (WIQ), were collected. The primary efficacy endpoint was the achievement of ≤30% final residual stenosis at the index lesion postatherectomy and adjunctive therapy evaluated by an angiographic Core Lab. The primary safety endpoint was the percentage of subjects who did not experience periprocedural major adverse events (PPMAEs) before discharge. One hundred and two subjects with 121 lesions treated with the 355 nm laser device at 10 centers were included in the analysis. Mean age was 68.4 ± 10.21 years, 61.8% of subjects were male, 44.6% had critical limb ischemia (CLI), and 47.3% had tibial lesions. The mean residual stenosis at the end of the procedure was 24.4 ± 15.5 with 69 lesions (69.0%) achieving technical procedural success (<30% stenosis); similar rates were observed for subjects with ISR (25.5 ± 14.9), chronic total occlusion (CTO) (28.1 ± 17.0), and severe calcification (36.5 ± 21.6) lesions. Mean ABI, Rutherford, and WIQ scores were improved at both 6 and 12 months. Ninety-seven of 102 subjects (95.1%) met the primary safety endpoint of not experiencing a PPMAE before discharge. The initial data from the Pathfinder Registry demonstrates the 355 nm laser system is safe and effective in a real-world setting for performing atherectomy in patients with infrainguinal PAD.

Background: Peripheral arterial disease is a ubiquitous disease that varies in terms of morbidity and mortality due to biologic sex, including the impact of traditional and non-traditional risk factors and sex-specific conditions that adds complexity and contributes to the existing disparities. Thus, understanding the sex-specific trends of PAD in the United States population is critical for developing targeted interventions. We sought to analyze the burden of PAD in male and female patients across the US from 1990 to 2019. Methods: Using the Global Burden of Disease (GBD) study data from 2019, we performed an analysis of the burden of PAD from 1990-2019, across US states. The GBD defined PAD based on studies that used symptom-based criteria and expressed the burden of PAD as the age-standardized prevalence and disability adjusted life years (DALYs) rates. We additionally estimated the regional relative change in DALYs. Results: In 2019, there were 5.4 million males and 7.1 million females with PAD in the US. Absolute PAD prevalence and DALYs increased in both sexes between 1990 and 2019, figure. The 2019 age-standardized prevalence of PAD (per 100,000) in the US in 2019 was 2,124 (95% Uncertainty Interval (UI): 1905-2354), and 2,302 (95% UI: 2,079-2,522) for females. Between 1990 and 2019, females had higher increase in age-standardized PAD DALYs compared with males (13.8% vs 5.5%). Significant state-level geographic variance was noted in age-standardized prevalence of PAD in both sexes (2-fold difference between lowest and highest state), figure. Conclusion: The burden of PAD is increasing in the US owing to the aging population. The absolute prevalence of PAD is higher in women compared with men in the US. Over the past 3 decades, there has been a more significant increase age-standardized PAD DALYs in women as compared with men. Future studies are needed to investigate and target these disparities.

ObjectiveTo examine the likelihood of response with continued galcanezumab treatment in patients with episodic or chronic migraine without initial clinical improvement.BackgroundA percentage of patients with migraine may require additional time on pharmacotherapy but discontinue treatment prematurely. Additionally, recognizing when continued treatment is unlikely to provide improvement limits unnecessary exposure.MethodsPost hoc analysis of response after continued galcanezumab treatment was conducted in a subset of patients with episodic (N = 879) and chronic (N = 555) migraine who did not achieve “good” early improvement (episodic, ≥50% reduction in baseline migraine headache days [MHD] and chronic, ≥30% reduction) after 1 month of dosing (NR‐1; episodic, n = 450 and chronic, n = 306). This subset was categorized by level of reduction in MHD during 1 month of treatment: “modest” (>30% to <50% fewer MHD for episodic and >10% to <30% fewer MHD for chronic), “limited” (episodic only; >10% to ≤30% fewer MHD), or “minimal/no” early improvement (≤10% fewer MHD to ≤10% more MHD), or “worsening” (>10% more MHD). The percentages of patients having “better” (≥75% fewer MHD for episodic and ≥50% for chronic), “good,” or “little‐to‐no” (≤10% fewer MHD) response during the remaining treatment period were calculated for each category. Similarly, the subset of NR‐1 patients who did not achieve “good” early improvement after 2 months of treatment (NR‐2; episodic, n = 290 and chronic, n = 240) were categorized by level of their average monthly reduction across 1 and 2 months using similar categories.ResultsOf NR‐1 patients with episodic migraine having “modest” early improvement, 62% (96/155) achieved “good” and 20% (31/155) achieved “better” responses with continued treatment. A percentage of patients with “limited” (43%; 46/108) or “minimal/no” (34%; 29/85) early improvement, or “worsening” (20%; 20/102) achieved a “good” response after continued treatment. A percentage of NR‐1 patients with chronic migraine having “modest” early improvement achieved “good” (38%; 44/116) and “better” (13%; 15/116) responses with continued treatment. A “good” response was achieved for a percentage of patients with “minimal/no” early improvement (17%; 23/133). Similar patterns were observed for the NR‐2 subset, though percentages were lower.ConclusionsGalcanezumab‐treated patients with episodic or chronic migraine without response following 1 or 2 months of treatment appear to have a reasonable likelihood of continued improvement in months following initial treatment and this opportunity is more likely in patients showing greater early improvements. While a small percentage of patients with episodic or chronic migraine who experienced worsening in the number of MHD following initial treatment responded with continued treatment, most do not show substantial reduction in MHD. Overall benefit of therapy should be determined collaboratively between the patient and physician.

Purpose: To report a prospective, multicenter, observational study (ClinicalTrials.gov identifier NCT01609621) of the safety and effectiveness of tibiopedal access and retrograde crossing in the treatment of infrainguinal chronic total occlusions (CTOs). Methods: Twelve sites around the world prospectively enrolled 197 patients (mean age 71±11 years, range 41-93; 129 men) from May 2012 to July 2013 who met the inclusion criterion of at least one CTO for which a retrograde crossing procedure was planned or became necessary. The population consisted of 64 (32.5%) claudicants (Rutherford categories 2/3) and 133 (67.5%) patients with critical limb ischemia (Rutherford category ≥4). A primary antegrade attempt to cross had been made prior to the tibiopedal attempt in 132 (67.0%) cases. Techniques used for access, retrograde lesion crossing, and treatment were at the operator’s discretion. Follow-up data were obtained 30 days after the procedure. Results: Technical tibiopedal access success was achieved in 184 (93.4%) of 197 patients and technical occlusion crossing success in 157 (85.3%) of the 184 successful tibial accesses. Failed access attempts were more common in women (9 of 13 failures). The rate of successful crossing was roughly equivalent between sexes [84.7% (50/59) women compared to 85.6% (107/125) men]. Technical success did not differ significantly based on a prior failed antegrade attempt: the access success rate was 92.4% (122/132) after a failed antegrade access vs 95.4% (62/65) in those with a primary tibiopedal attempt (p=0.55). Similarly, crossing success was achieved in 82.8% (101/122) after a failed antegrade access vs 90.3% (56/62) for patients with no prior antegrade attempt (p=0.19). Minor complications related to the access site occurred in 11 (5.6%) cases; no patient had access vessel thrombosis, compartment syndrome, or surgical revascularization. Conclusion: Tibiopedal access appears to be safe and can be used effectively for the crossing of infrainguinal lesions in patients with severe lower limb ischemia.

Chemotherapy improves breast cancer survival but is underused more often in black than in white women. We examined associations between patient-physician relationships and chemotherapy initiation and timeliness of initiation among black and white patients. Women with primary invasive, non-metastatic breast cancer were recruited via hospitals (in Washington, DC and Detroit) and community outreach between July 2006 and April 2011. Data were collected via telephone interviews and medical records. Logistic regression models evaluated associations between chemotherapy initiation and independent variables. Since there were race interactions, analyses were race-stratified. Factors associated with time from surgery to chemotherapy initiation and delay of ≥90 days were evaluated with linear and logistic regressions, respectively. Among eligible women, 82.8 % were interviewed and 359 (90.9 %) of those had complete data. The odds of initiating chemotherapy were 3.26 times (95 % CI: 1.51, 7.06) higher among black women reporting greater communication with physicians (vs. lesser), after considering covariates. In contrast, the odds of starting chemotherapy were lower for white women reporting greater communication (vs. lesser) (adjusted OR 0.22, 95 % CI: 0.07, 0.73). The opposing direction of associations was also seen among the sub-set of black and white women with definitive clinical indications for chemotherapy. Among those initiating treatment, black women had longer mean time to the start of chemotherapy than whites (71.8 vs. 55.0 days, p = 0.005), but race was not significant after considering trust in oncologists, where initiation time decreased as trust increased, controlling for covariates. Black women were also more likely to delay ≥90 days than whites (27 vs. 8.3 %; p = 0.024), but this was not significant after considering religiosity. The patient-physician dyad and sociocultural factors may represent leverage points to improve chemotherapy patterns in black women.

No abstract available.