Finding the optimal access for proximal upper limb artery (PULA) interventions: Lessons learned from the PULA multicenter registry.

OBJECTIVE: The multicenter proximal upper limb artery (PULA) Registry was created to study the optimal puncture sites for the interventions involving the subclavian, axillary, and innominate arteries. BACKGROUND: Little is known about the optimal vascular access for PULA interventions, despite the well-known technical complexity of these procedures. METHODS: We performed the retrospective analysis of consecutive patients treated for symptomatic steno-occlusive disease of the proximal upper limb arteries between January 2015 and December 2019 in three high-volume centers. Acute thrombotic occlusions were excluded from the study. RESULTS: Two hundred and seventy-two patients were treated for significant stenosis and 108 for total occlusion. The baseline patient's characteristics were similar, except for the higher median age of the stenotic patients: 68.5 years (31.1; 90.0) versus 64 years (38.0; 86.0) p = 0.0015. Successful revascularization rate was higher in the stenotic group 93.75% (255/272) versus 86.11% (93/108) p = 0.0230, while the procedure length 27 min (8; 133) versus 46 min (7; 140) p = 0.0001 and fluoroscopy times 439 s (92; 2993) versus 864 s (86; 4176) p = 0.0001 were higher in the occlusion group. The main adverse event rate was similarly low. Dual access was used more often to treat occlusions (60.19% (65/108) vs. 11.40% (31/272) p = 0.0001) without significantly increasing the complication rate. The safest access was ultrasound-guided distal radial artery puncture, significantly better than conventional radial access with 0% (0/31) versus 13.6% (18/131) p = 0.0253 complication. CONCLUSIONS: The percutaneous revascularization of proximal upper limb arteries is a safe and effective. Dual access can be applied to increase treatment efficacy, without significantly compromising safety.

Clinical Impact of Weight-Loss Pharmacotherapy in Patients with Atherosclerotic Cardiovascular Disease.

Obesity is associated with the development and progression of multiple cardiovascular risk factors, such as hypertension, dyslipidemia, and type 2 diabetes mellitus, and is an important contributor to the global burden of atherosclerotic cardiovascular disease (CVD). Guidelines suggest that clinicians provide lifestyle counseling and promote lifestyle modifications before considering weight-loss surgery. However, despite lifestyle modifications and increased physical activity, most patients with obesity will not lose significant weight or will experience weight regain. Weight-loss pharmacotherapy added to lifestyle modification has long been perceived as a bridge between lifestyle modifications alone and weight-loss surgery. However, since its inception, weight-loss pharmacotherapy has been plagued by variable efficacy and concern about cardiovascular safety. Following requirements from regulatory authorities, efficacy and cardiovascular safety trials have been conducted for the currently available weight-loss pharmacotherapeutic agents. Overall, these trials have shown that weight-loss pharmacotherapy is only modestly efficient for the inducement of weight loss. Recent trials have also demonstrated the cardiovascular safety of some of these agents. We review these trials with a focus on the clinical impact of these weight-loss pharmacotherapeutic agents in patients with atherosclerotic CVD.

Long-Term Outcomes and Weight Loss After Bariatric Embolization of the Left Gastric Artery.

OBJECTIVES: Bariatric embolization of the left gastric artery is a promising technique to induce weight loss in obese patients. We aimed to assess long-term effects. METHODS: Patients with severe obesity were recruited to undergo left gastric artery embolization via transradial access. We report clinical outcomes and weight loss up to 2 years. RESULTS: We completed 7 procedures successfully in 7 men with severe obesity after diagnostic coronary angiography. Median weight was 160 kg (interquartile range, 140.0-180.0 kg) and body mass index was 49.4 kg/m² (interquartile range, 43.2-61.7 kg/m²). Acutely, no adverse events were reported other than mild epigastric pain, which subsided within 24 hours with proton pump inhibitors. No delayed gastrointestinal complications were reported up to 2 years after index procedure. One patient died of pulmonary embolism 18 months after the procedure. One patient underwent a second embolization procedure after it was shown that the left gastric artery was patent 18 months after the initial procedure. Compared with baseline in the 6 surviving patients, overall weight loss was 7.7% (range, 3.2%-14.1%). CONCLUSIONS: Bariatric embolization of the left gastric artery may induce weight loss, which appears sustained up to 2 years. Spontaneous recanalization of the left gastric artery may pave the way for repeat procedures and other interventions. Further research is necessary to define the benefits, safety, and indications for this technique.

Outcomes in Patients with Obesity and Coronary Artery Disease with and Without Bariatric Surgery.

OBJECTIVES: The clinical benefit of bariatric surgery in patients with severe obesity and established coronary artery disease (CAD) is unclear. We aimed to compare the cardiovascular outcomes of severely obese CAD patients with and without bariatric surgery. METHODS: Patients with a history of myocardial revascularization documented prior to bariatric surgery were identified from a dedicated database with prospectively collected outcomes. These patients were matched 1 to 1 with CAD patients who had prior revascularization but who did not undergo bariatric surgery. The primary outcomes were death (cardiac and non-cardiac) and major adverse cardio-cerebral events (MACCE), including death, myocardial infarction (MI), stroke, and repeat myocardial revascularization throughout follow-up. RESULTS: After propensity score matching, 116 bariatric patients were matched with 116 control patients. Ninety-eight had a history of coronary artery bypass surgery and 134 had a previous percutaneous coronary intervention. After a median follow-up of 8.9 (6.3-14.2) years, MACCE was significantly lower in the bariatric group (HR 0.65; 95% CI 0.42-1.00; P = 0.049) driven by a significant reduction in non-cardiac mortality (HR 0.49; 95% CI 0.23-1.00; P = 0.049). There was no significant difference in the rates of all-cause death (HR 0.58; 95% CI 0.33-1.01; P = 0.056), cardiovascular death (HR 0.77; 95% CI 0.31-1.85; P = 0.55), MI (HR 1.09; 95% CI 0.47-2.58; P = 0.85), stroke (HR 1.47; 95% CI 0.24-11.2; P = 0.67), and repeat myocardial revascularization (HR 0.56; 95% CI 0.27-1.13; P = 0.11). CONCLUSION: Although bariatric surgery in obese CAD patients may reduce the composite MACCE endpoint during long-term follow-up, this effect seems unrelated to cardiovascular outcomes.

Radial Approach for Left Gastric Artery Angiography and Embolization for the Treatment of Obesity: Technical Considerations.

BACKGROUND/PURPOSE: Bariatric embolization of the left gastric artery (LGA) is being investigated as a technique to induce substantial weight loss in obese patients. Radial access is associated with less vascular complications than femoral access, especially in patients with severe obesity. We sought to assess the feasibility, safety and technical challenges of LGA angiography through radial access. METHODS/MATERIALS: Patients with suspected coronary artery disease (CAD) and obesity (BMI > 30 kg/m2) referred for diagnostic catheterization and/or percutaneous coronary intervention (PCI) were eligible. After completion of diagnostic and/or PCI, selective cannulation of celiac artery was performed and images of the LGA were taken from multiple views. Detailed procedural parameters such as procedure time, contrast volume and radiation data as well as anatomical variations were assessed. RESULTS: Between February and December 2018, we successfully achieved 50 selective angiographies of celiac artery from 54 enrolled patients (92.6%) and LGA was optimally visualized in 47/50 (97%) of cases. Right radial access was used in 50 cases. Mean age was 63.9 ±â€¯8.0 years and 74% were men. Median BMI was 34.4 kg/m2 [32.2-39.4]. The median procedural time was 7 [5-10] minutes, contrast volume was 41 ml [33-63], fluoroscopy time was 160 [103-248] seconds and radiation exposure was 3125 [1906-4735] Gy.cm2. No complications were noted. The mean difficulty of the procedure on a visual analogue scale was 4/10. CONCLUSIONS: LGA angiography via transradial approach was feasible in the large majority of CAD patients with obesity. No safety issues were encountered.

Comparison of Short and Long Term Cardiovascular Outcomes After Bariatric Surgery in Patients With vs Without Coronary Artery Disease.

There is little data regarding the risks and benefits of bariatric surgery in patients with coronary artery disease (CAD). We aimed to assess the short- and long-term cardiovascular outcomes of patients with CAD undergoing bariatric surgery. Patients with a history of CAD were identified from a dedicated database with prospectively collected outcomes, comprising all 6795 patients who underwent bariatric surgery between January 1992 and October 2017. Patients were matched with patients who did not have CAD before the bariatric surgery procedure. The primary endpoints were mortality (cardiac and noncardiac) and major adverse cardiocerebral events (MACCE), including all-cause death, myocardial infarction, stroke, and myocardial revascularization at 30 days after bariatric surgery and throughout follow-up. After propensity score matching, 249 patients with chronic CAD were matched with 249 patients without CAD. Throughout follow-up (7.4 years; interquartile range 4.1 to 11.5, maximum 22 years), mortality (mainly cardiac mortality) remained significantly higher in the CAD compared with the non-CAD group (18% vs 10%, hazard ratio [HR] 1.70, 95% confidence interval [CI]: 1.03 to 2.79, p = 0.037). At 30 days, MACCE rate was significantly higher in the CAD compared with the non-CAD group (3.6% vs 0.4%, p = 0.011), essentially driven by non-ST elevation myocardial infarctions. After 30 days, MACCE rates remained significantly higher in the CAD group (30% vs 14%, HR 2.18, 95% CI: 1.45-3.28, p = 0.0002). In conclusion, patients with severe obesity and CAD referred to bariatric surgery were at a higher risk of early and late MACCE compared with non-CAD severely obese patients. Further study is required to define how this cardiovascular risk compares with nonoperated patients.

Transradial left gastric artery embolization to treat severe obesity: A pilot study.

BACKGROUND: Bariatric surgery is currently the only effective treatment with long-lasting results to treat severe obesity. OBJECTIVES: We performed a pilot study to evaluate the feasibility, safety and efficacy of percutaneous distal embolization of the left gastric artery (LGA) using a transradial approach. METHODS AND RESULTS: We recruited seven severely obese male patients (mean age 48 ± 7 years) referred for diagnostic coronary angiography. Mean baseline weight was 160 ± 27 kg and body mass index was of 52 ± 8 kg/m2 . We successfully injected 300-500 µm polyvinyl alcohol particles using 5Fr catheters and all distal LGA were occluded at the end of procedures. Mean procedure duration was 24 ± 13 min and mean fluoroscopy time was 10 ± 5 min. Six patients reported mild transient epigastric discomfort, which resolved with proton pump inhibitors. At 2 months, the average weight loss was of 7 ± 6 kg (median loss: -10 kg [-2, -11]), 6 ± 12 kg (median loss: -9 kg [-16, +4]) at 6 months and 13 ± 17 kg (median loss: -11 kg [0, -25]) up to 12 months after index procedures. CONCLUSION: Percutaneous transradial LGA embolization appears to be a promising technique to reduce the obesity burden. Randomized trials are required to further delineate the risk/benefit ratio, potential clinical indications and long term results.

A Randomized Double-Blind Placebo-Controlled Study Comparing Intracoronary Versus Intravenous Abciximab in Patients With ST-Elevation Myocardial Infarction Undergoing Transradial Rescue Percutaneous Coronary Intervention After Failed Thrombolysis.

The risk and benefit ratio of glycoprotein IIb/IIIa inhibitors with dual oral antiplatelet therapy after failed thrombolysis and rescue percutaneous coronary intervention (PCI) is unclear. Using a randomized placebo-controlled, double-blind design, we compared intravenous (IV) and intracoronary (IC) abciximab delivery in 74 patients referred for rescue transradial PCI. The primary angiographic end points were the final thrombolysis in myocardial infarction flow and myocardial blush grades. Secondary end points included acute and 6-month outcomes using angiographic parameters, platelet aggregation parameters, cardiac biomarkers, cardiac magnetic resonance measurements (CMR) and clinical end points. After rescue PCI, normal thrombolysis in myocardial infarction 3 flows were obtained in 70% in the IC group, 48% in the IV group, and 71% in the placebo group, respectively (p = 0.056). Final myocardial blush grades 2 and 3 were obtained in 43% and 39% in the IC group, 48% and 26% in the IV group, and 46% and 42% in the placebo group (p = 0.67), respectively. Acutely, peak release of cardiac biomarkers, necrosis size, myocardial perfusion and no-reflow as assessed by CMR, and clinical end points were similar between the groups and did not suggest a benefit for IC or IV abciximab compared with placebo. There was no increase in bleeding or access site-related complications with abciximab compared with placebo. Clinical, angiographic, and CMR outcomes at 6 months remained comparable between the groups. In patients with ST-elevation myocardial infarction presenting with failed thrombolysis undergoing transradial rescue PCI, IC or IV abciximab had no significant clinical impact.

Pretreatment with P2Y12 inhibitors and outcome in patients with ST-segment elevation myocardial infarction treated by primary percutaneous coronary intervention.

AIMS: Preload with clopidogrel, ticagrelor, or prasugrel in the setting of ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI) is frequently applied. Limited data are available regarding the outcome impact of pretreatment with these drugs in the real world. METHODS AND RESULTS: The outcome of 760 STEMI patients treated by primary PCI receiving clopidogrel, prasugrel, or ticagrelor (n = 269, 327, 164, respectively) was evaluated. Patients in the clopidogrel group were older, whereas those in the ticagrelor group had less hypertension but were more active smokers. Angiographic characteristics were comparable among the three groups. At 1 month, more events were observed in the clopidogrel group (11.1%) than in the ticagrelor and prasugrel groups (7.1 vs. 5.1%, P = 0.025), whereas the number of events in the ticagrelor and prasugrel groups did not differ. At 1 year, similar differences existed, mainly driven by a higher rate of death (19.5%, P = 0.008) or stent thrombosis (2 vs. 1.3% for ticagrelor, P = 0.132; vs. 0.3% for prasugrel, P = 0.07) in the clopidogrel group. In-hospital and 1-year bleeding rates were similar between groups. CONCLUSION: In real-world practice, pretreatment with prasugrel or ticagrelor in ongoing STEMI treated by primary PCI seems to be a well tolerated alternative strategy compared with clopidogrel but provides superior benefit in terms of outcomes.

Transradial experience with bioresorbable vascular scaffolds: A case-matched study with metallic drug-eluting stents.

BACKGROUND: Whether polymeric bioresorbable vascular scaffolds (BVS) implantation with transradial approach is feasible and safe is unknown. We compared the feasibility and safety of the transradial approach for BVS delivery with metallic drug-eluting stents (DES). METHODS: We identified 118 consecutive patients who underwent BVS implantation and we compared 30-days and 1-year results with 118 matched patients with DES. Patients were matched for age, sex, risk factors and clinical indication. RESULTS: Rates of transradial approach were 98% in the BVS group vs 95% in the DES group (P = 0.16) with 5Fr used in 38% and 32% (P = 0.34), respectively. The number of stents was similar in both groups, 2.6 ±â€¯1.5 vs 2.4 ±â€¯1.3 (P = 0.23). Although maximal pressure for stent deployment was identical in both groups (16 ±â€¯3 atm), more lesions were pre-dilated (83% vs 52%, P < 0.001) and post-dilated (71% vs 33%, P < 0.001) in the BVS group. Contrast volume (217 ±â€¯97 vs 175 ±â€¯108 ml, P < 0.001), fluoroscopy time (16 [10-23] vs 13 [8-21] min, P = 0.04) and procedure duration (65 ±â€¯31 vs 56 ±â€¯47 min, P = 0.045) were significantly higher in the BVS group. Major adverse cardiac events, including death, myocardial infarction and target vessel revascularization remained similar in both groups, 1.7% vs 0.8% (P = 0.56) at 30 days and 10% vs 8.5% (P = 0.66) at 1 year. At 1 year, stent thrombosis occurred in 2 (1.7%) patients in the BVS group and 1 (0.8%) patient in the DES group (P = 0.56). CONCLUSION: The use of transradial approach for BVS compared to DES implantation was feasible and safe in all-comers, although BVS implantation included more technical challenges. Outcomes up to 1-year remained comparable in both groups.

Ratio of high-sensitivity troponin to creatine kinase-MB in takotsubo syndrome.

BACKGROUND: Takotsubo syndrome (TT) and myocardial infarction (MI) share numerous similarities in clinical presentation, ECG modifications and biomarker elevation. We sought to determine whether the ratio of high-sensitivity cardiac troponin T (hs-TnT) to the myocardial fraction of creatine kinase (CKMB) could be a potent discriminator between TT and MI patients. METHODS: We separately present analysis of data from retrospective files and prospectively recruited patients presenting with TT (35 retrospective and 42 prospective), NSTEMI (48 retrospective and 75 prospective) and STEMI (20 retrospective and 39 prospective). We compared ratios of hs-TnT to CKMB on admission to the hospital between TT, NSTEMI and STEMI patients. Receiver operating characteristic (ROC) curves were analysed to determine optimal cut-off values. RESULTS: On admission, hs-TnT/CKMB ratio was significantly higher in TT patients than in NSTEMI and STEMI patients in both the retrospective phase (median and interquartile range, TT 0.024 [0.018-0.047] vs NSTEMI 0.009 [0.006-0.022], p<0.0001; TT vs STEMI 0.011 [0.006-0.016], p=0.0002) and the prospective cohort (median and interquartile range, TT 0.032 [0.018-0.040] vs NSTEMI 0.009 [0.006-0.015], p<0.0001; TT vs STEMI 0.009 [0.005-0.017], p<0.0001). A cut-off hs-TnT/CKMB ratio of 0.015 distinguished TT from MI with a sensitivity of 85.7% and a specificity of 67.6% (AUC 0.796; 95%CI: 0.71-0.89) in the retrospective phase. In the prospective phase, a ratio of 0.017 distinguished TT from MI with a sensitivity of 83.3% and a specificity of 78.1% (AUC 0.88; 95%CI: 0.83-0.94). CONCLUSION: hs-TnT/CKMB ratio is a novel, readily available parameter that could be used alongside clinical risk scores, other biomarkers and ECG findings to discriminate between TT and MI.

Duration of dual anti-platelet therapy - State of the art after the DAPT and PEGASUS-TIMI 54 trials.

Dual anti-platelet therapy is prescribed in the setting of coronary heart disease for the prevention of stent thrombosis and acute thrombotic events. The optimal duration of dual anti-platelet therapy is still under debate as numerous trials have shown non-inferiority of a strategy of early cessation of one of the agents as compared to the standard practice whereas two larger trials have demonstrated benefit of prolonging dual anti-platelet therapy.

Prognostic importance of exercise brain natriuretic peptide in asymptomatic degenerative mitral regurgitation.

AIM: The exercise Doppler echocardiographic stress test can be of interest in the management of asymptomatic patients with primary mitral regurgitation (MR). The resting brain natriuretic peptide (BNP) level is a good surrogate marker of the consequences of MR and is a powerful predictor of outcome. The incremental prognostic value of BNP response during exercise is unknown. We aimed to identify the determinants of exercise BNP level and to evaluate its prognostic value in asymptomatic patients with primary MR. METHODS AND RESULTS: Comprehensive resting and exercise transthoracic Doppler echocardiography was performed in 113 consecutive asymptomatic patients with moderate to severe degenerative MR and preserved left ventricular (LV) function. Blood samples were collected both at rest and during exercise. The BNP level significantly increased from rest to exercise (P < 0.0001). The independent determinants of exercise BNP were resting E/Ea ratio (P = 0.043), indexed left atrial volume (P = 0.022), and exercise LV global longitudinal strain (P = 0.001). There was a significant graded relationship between increasing BNP level at exercise (according to tertiles) and increased incidence of cardiac events (death, heart failure, mitral valve surgery driven by symptoms, or LV dilatation/dysfunction onset) (1 year, 11 ± 5% vs. 14 ± 6% vs. 43.5 ± 9%; 2 years, 21 ± 7% vs. 40 ± 8% vs. 67 ± 9%; in tertiles 1, 2 and 3, respectively). On multivariable analysis, after adjustment for demographic and echocardiographic data and for resting BNP level, exercise BNP remained significantly associated with increased risk of cardiac events during the follow-up (hazard ratio 2.8 and 3.4, P = 0.041 and 0.023, for tertiles 2 and 3, as compared with tertile 1). CONCLUSIONS: In asymptomatic patients with primary MR, exercise BNP level provides incremental prognostic value beyond what is achieved by demographic and echocardiographic data and resting BNP level. Patients with elevated exercise BNP should be considered at high risk of reduced cardiac event-free survival.

Prognostic importance of brain natriuretic peptide and left ventricular longitudinal function in asymptomatic degenerative mitral regurgitation.

OBJECTIVES: To identify the determinants and the impact on outcome of brain natriuretic peptide (BNP) in asymptomatic patients with degenerative mitral regurgitation (MR). METHOD: Comprehensive transthoracic echocardiography including two-dimensional speckle tracking quantification was performed in 135 consecutive asymptomatic patients (60±14 years, 56% men) with moderate to severe degenerative MR and preserved left ventricular (LV) function. Blood samples were collected at the time of the echocardiography and plasma BNP levels were measured. MAIN OUTCOME MEASURES: BNP level and cardiac events. RESULTS: BNP was correlated with age, indexed LV end-systolic diameter, indexed left atrium (LA) volume, estimated LV filling pressure with E/Ea ratio, systolic pulmonary arterial pressure and global longitudinal strain (GLS). In multiple regression analysis, indexed LA volume (p=0.008), mitral deceleration time (p=0.003) and GLS (p<0.0001) were independently associated with BNP. During follow-up (mean=23±19 months), 54 events occurred resulting in 4-year event-free survival of 50±6%. There was a graded relationship between the increase in BNP (ie, according to quartile) and reduced event-free survival (p<0.0001). In Cox multivariable analysis, indexed LA volume (HR=1.04, p=0.003), GLS (HR=1.14, p=0.007) and 3rd and 4th quartiles of BNP (HR=8.5, p=0.002 and HR=8.8, p=0.002) were independent determinants of event-free survival. CONCLUSION: In asymptomatic degenerative MR, LV longitudinal function and LA volume are the main determinants of BNP release. BNP is a powerful independent predictor of cardiac events. Measurement of plasma BNP may help to improve risk stratification and management of asymptomatic patients with degenerative MR.