Jetstream Atherectomy Followed by Paclitaxel-Coated Balloons versus Balloon Angioplasty Followed by Paclitaxel-Coated Balloons: Twelve-Month Exploratory Results of the Prospective Randomized JET-RANGER Study.

Background: It is unknown at this time whether Jetstream atherectomy (JET) and paclitaxel-coated balloon (PCB) provides a superior outcome to balloon angioplasty (PTA) followed by PCB in treating femoropopliteal (FP) arterial disease. Methods: The JET-RANGER study was a multicenter (eleven US centers) randomized trial, core lab-adjudicated, designed to demonstrate the superiority of JET + PCB versus PTA + PCB in treating FP arterial disease. The study intended to enroll 255 patients, but was stopped early because of poor enrollment due to COVID-19 and concerns about the association of paclitaxel with mortality. The data are thus considered exploratory. A total of 47 patients (48 lesions) with claudication (80.9%) or rest pain/ulcerations (19.2%) were randomly assigned 2:1 to JET + PCB (n=31) or PTA + PCB (n=16). The In.PACT (Medtronic) and Ranger (Boston Scientific) PCBs were used. Freedom from target-lesion revascularization (TLR) was evaluated at 1 year. Analysis was performed on intention to treat. Results: Mean lesion length was 10.8±4.3 cm for JET + PCB and 11.2±7.6 cm for PTA + PCB (P=0.858). There were no other differences in demographic or angiographic variables between the two groups. Procedural success was superior with JET + PCB (87.1%) vs PTA + PCB alone (52.9%; P=0.0147). Overall bailout stenting rate was 17% (0 JET + DCB versus 50% PCB, P<0.0001). There was no distal embolization requiring treatment. There was no amputation or death in either group. Using KM analysis, the primary end point of freedom from TLR (bailout stent considered a TLR) at 1 year was 100% and 43.8% (P<0.0001) for JET + PCB versus PTA + PCB, respectively. When bailout stent was not considered a TLR, freedom from TLR was 100% and 93.7%, respectively (P=0.327). Conclusion: A high rate of freedom from TLR was seen in the JET + PCB arm and the PTA + DCB arm at 1-year follow-up, with a significant reduction in bailout stenting following vessel prepping with the Jetstream.

Gender Differences in the Outcomes of Drug-Coated Balloon Treatment in Symptomatic Femoropopliteal Arterial Disease.

OBJECTIVES: To assess 24-month outcome differences based on sex in symptomatic femoro-popliteal arterial disease of patients treated with drug-coated balloon (DCB). BACKGROUND: Peripheral artery disease affects over 12 million people in the United States. Drug-coated balloons have shown to be effective in treating patients with symptomatic femoropopliteal arterial occlusive disease. Debate remains regarding its safety and efficacy in female gender. We investigated the differential treatment effect between genders. METHODS: Patients (93 females and 102 males) with symptomatic femoropopliteal arterial disease treated with DCB from November 2014 to November 2015 were included in this retrospective study. We compared the resting ankle-brachial indices (ABIs) and peak systolic velocities (PSVs) by arterial duplex between the male and female patients at 6, 12, and 24 months postintervention. RESULTS: Females had significantly smaller vessels (4.70 ± 0.9, P = .02) and higher body mass index (BMI; 30.0 ± 3.7, P = .002) than males. Females had significantly decreased ABI and PSV at the 6-month (ABI: 0.90 ± 0.15, P = .05 and PSV: 188.30 ± 103.1, P = .02), 12-month (ABI: 0.86 ± 0.15, P < .0001 and PSV: 219.10 ± 100.10, P = .001), and at 24-month (ABI: 0.84 ± 0.2, P = .0001 and PSV: 251.0 ± 135.9, P < .0001) intervals when compared to males. Females had increased clinically driven target lesion revascularization (TLR) at 6 months (females = 8 vs males = 4, P = .22), 12 months (females = 12 vs males = 4, P = .02), and 24 months (females = 14 vs males = 6, P = .03). In simple logistic regression analysis, BMI, age, reference vessel diameter (RVD), and gender were strongly associated with target lesion restenosis. The final model included the above and it produced the following odds ratios (ORs): BMI (OR = 1.07, 95% confidence interval [CI]: 0.98-1.2), age (OR: 1.0, CI: 0.96-1.03), RVD (OR: 1.6, CI: 1.02-2.4), and gender (OR: 3.5, CI: 1.6-7.8). CONCLUSION: Females treated with DCBs have significantly decreased ABI, PSVs, and an increased rate of TLR than their male counterparts.

Histological features of restenosis associated with paclitaxel drug-coated balloon: implications for therapy.

PURPOSE: To investigate the cellular and extracellular changes induced by drug-coated balloons (DCB) in the treatment of superficial femoral artery (SFA) restenosis, and to compare histopathological features with those observed after plain old balloon angioplasty (POBA) from the same patients. METHODS AND RESULTS: Plaque samples for five patients with SFA restenosis (first-time) after POBA were collected using atherectomy and DCB. These samples constitute the POBA restenosis group. The same five patients developed recurrent restenosis (RR) after DCB, at the same intervention site. These SFA-RR lesions were again treated using atherectomy and POBA. These samples constitute the DCB restenosis group. DCB restenosis group plaques showed significant reduction in neointima, smooth muscle cells, fibroblast densities, and Ki67 index; and increase in caspase 3, features of apoptosis and type III collagen deposition in comparison to the POBA restenosis group. CONCLUSION: Plaque tissue from the DCB restenosis group show reductions in neointimal thickness, cellularity, and cellular proliferation, along with increased apoptosis, and Type III collagen content. These results suggest a different mechanistic pathway for DCB restenosis, in which neointimal proliferation is reduced but reparative fibrosis is increased. The treatment for SFA-RR after DCB may therefore benefit from different forms of therapy including scaffolding, rather than recurrent anti-proliferative therapy.

Tricuspid Annular Plane Systolic Excursion and Its Association with Mortality in Critically Ill Patients.

BACKGROUND: Transient left ventricular dysfunction can occur under conditions of extreme emotional or physiological stress. There is little data on right ventricular function in such situations. METHODS: One hundred twenty patients admitted to an ICU with a noncardiac illness were studied. Those with documented coronary disease, ejection fraction <40%, sepsis, or intracranial hemorrhage were excluded. Echocardiograms were performed within 24 hours of admission. Tricuspid annular plane systolic excursion (TAPSE) was measured to assess right ventricular systolic function. Plasma catecholamines (norepinephrine, epinephrine, dopamine) were measured on admission. Clinical and demographic data were collected, along with data on ICU length of stay (LOS), hospital LOS, and in-hospital and long-term mortality. TAPSE was tested for correlation with adverse outcomes and length of stay. RESULTS: Mean TAPSE for the group was 2.05 ± 0.66 cm. Based on area under the ROC curve analysis, TAPSE <2.4 cm was the best cutoff for predicting in-hospital and long-term mortality. There were 13 in-hospital deaths, 12 in the group with TAPSE <2.4 cm and one among those with TAPSE ≥2.4 cm. On multivariate analysis, TAPSE <2.4 cm was a significant predictor of in-hospital mortality (χ(2)  = 4.6, P = 0.03). When tested against hospital LOS, an inverse correlation was found (P = 0.04). No association was found between TAPSE and catecholamine levels. CONCLUSIONS: Right ventricular systolic function, as assessed by TAPSE, has important prognostic value in critically ill patients. Mean values were lower in patients who died in-hospital versus those who survived to discharge. In addition, patients with TAPSE <2.4 cm had a longer hospital length of stay.

Acute Limb Ischemia.

Acute limb ischemia is a vascular event presenting with sudden decrease in limb perfusion (of <14 days' duration) that threatens limb viability. Acute thrombosis of the native artery or graft makes up the bulk of etiopathogenesis. Prompt revascularization is the cornerstone of management of acute limb ischemia in limbs that have not undergone irreversible tissue and nerve damage. Amputation is performed in patients with irreversible tissue and nerve damage.

Distribution of dyssynchrony in subjects with no known cardiac disease and comparison of velocity vector imaging to color-coded tissue Doppler imaging.

Data on the distribution of dyssynchrony in subjects with normal ejection fraction (EF) and normal QRS are scarce. We studied 100 subjects with no known cardiac disease (52% male, mean age 60 ± 17 years) using velocity vector imaging (VVI). Seventeen percent had septal to lateral (S-L) wall longitudinal delay >75 msec, 63% of subjects had S-L wall radial delay >75 msec, and 25% had a circumferential opposing wall delay >100 msec. Those with circumferential opposing wall delay of >100 msec had a lower EF (57 ± 5% vs. 62 ± 5%, P < 0.05). In an additional group of 33 patients, we compared the longitudinal dyssynchrony parameters as assessed by VVI and tissue Doppler imaging (TDI) and found them to be comparable. In conclusion, we find significant variation in time to peak velocities in subjects with no known cardiac disease, who had a normal left ventricular ejection fraction and QRS duration. VVI is comparable to TDI.

Dyssynchrony in obese subjects without a history of cardiac disease using velocity vector imaging.

BACKGROUND: The aim of this study was to examine the occurrence of intra-left ventricular (LV) dyssynchrony in obese versus nonobese subjects without known cardiac disease using Velocity Vector Imaging (VVI). METHODS: One hundred ninety consecutive subjects with no known cardiac disease had their echocardiograms analyzed using VVI after excluding subjects with QRS durations>120 msec or LV ejection fractions<55%. Study subjects were divided into two groups on the basis of body mass index: obese (>30 kg/m2) and nonobese (<30 kg/m2). RESULTS: The final cohort included 136 subjects (74 obese; 32% women; mean age, 55±16 years). The occurrence of intra-LV dyssynchrony was higher in the obese group compared with the nonobese group. CONCLUSIONS: There was an increased prevalence of intra-LV dyssynchrony in obese subjects, especially longitudinal and radial dyssynchrony. This dyssynchrony may signal a mechanism by which obesity predisposes to the development of heart failure.

Can total cardiac calcium predict the coronary calcium score?

BACKGROUND: Mitral annular calcification (MAC) shares the same risk factors as atherosclerosis and is associated with coronary artery disease as well as cardiovascular events. However, sensitivity and positive predictive value are low. We hypothesized that a global echocardiographic calcium score would better predict coronary atherosclerotic burden, as assessed by coronary artery calcium score (CAC), than MAC alone. METHODS: An echocardiographic score was devised to measure global cardiac calcification in a semi-quantitative manner; this included calcification in the aortic valve and root, the mitral valve and annulus, and the sub-mitral apparatus. This score, and a simplified version, were compared with a similar calcification score by CT scan, as well as the CAC. RESULTS: There was a good correlation between the two global calcification scores; the echocardiographic score also correlated with CAC. Using CAC >400 as a measure of severe coronary atherosclerosis, an echocardiographic score ≥5 had a positive predictive value of 60%. Importantly, the simplified score performed equally well (≥3 had a positive predictive value of 62%). CONCLUSIONS: Global cardiac calcification, assessed by CT scan or echocardiography, correlates with the extent of coronary calcium. A semi-quantitative calcium score can be easily applied during routine echocardiographic interpretation and can alert the reader to the possibility of severe coronary atherosclerosis.

Relation between common allergic symptoms and coronary heart disease among NHANES III participants.

We investigated whether there is an increased risk of coronary heart diseases (CHD) in those with common allergic symptoms using the NHANES III, which is a representative sample of the United States population in 1988 to 1994. CHD was defined by Rose questionnaire and history of heart attack. Allergic symptoms were categorized into no symptoms (NO), rhinoconjunctivitis without wheezing (RC), and wheezing (WZ) based on symptoms. Multivariate logistic regression was used to obtain odds ratios (ORs) of CHD. Eight thousand six hundred fifty-three nonpregnant subjects ≥20 years old with overnight fasting ≥8 hours were included. CHD was present in 5.9% of the population; 36.5% did not have allergic symptoms (NO), 45.9% had RC, and 17.6% had WZ. The prevalence of CHD was 3.9% in NO, 4.8% in RC, and 12.8% in WZ (p <0.001). Compared to NO, unadjusted ORs of CHD were 1.24 (95% confidence interval 0.94 to 1.62) in RC and 3.58 (2.68 to 4.78) in WZ and ORs adjusted for sociodemographic factors and co-morbidities were 1.40 (1.02 to 1.92) in RC and 2.64 (1.79 to 3.90) in WZ. Only the group of women <50 years of age had significantly increased ORs in RC and WZ. In conclusion, common allergic symptoms were significantly associated with an increased risk of CHD.