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.
Objectives
To review the technical limitations of available pressure‐wires, present the design evolution of a nitinol fiber‐optic pressure wire and to summarize the First‐in‐Man (FIM) O2 pilot study ...results.
Background
Despite increasing use of physiology assessment of coronary lesions, several technical limitations persist. We present technical details, design evolution and early clinical results with a novel 0.014” nitinol fiber‐optic based pressure‐wire.
Methods and Results
The 0.014’ OptoWire™ (Opsens Medical, Quebec, Canada) was designed to combine improved handling properties compared to standard pressure‐wires and to offer extremely reliable pressure recording and transmission due to fiber‐optic properties compared to piezo‐electric sensors and electrical wires. In vitro assessment showed that OptoWire™ steerability, pushability and torquability properties were closer to regular PCI wires than standard electrical pressure wires. In the First‐in‐Man O2 study, 60 patients were recruited at 2 centers in Canada. A total of 103 lesions were assessed with the OptoWire™ and OptoMonitor™, 75 lesions at baseline and 28 lesions post‐PCI (without disconnection). In all crossed lesions (n = 100, 97%), mean Pd/Pa and FFR could be adequately measured. In 11 cases assessed successively with OptoWire™ and Aegis™ (Abbott Vascular, USA) bland‐Altman analysis showed a mean difference of 0.002 ± 0.052 mmHg (p = .91) for Pd/Pa and 0.01 ± 0.06 for FFR calculation (p = .45). There was no device‐related complication. Upon these initial results, several design changes aimed to improve overall performance including torquability, stiffness, resistance to kink and pressure drift were completed.
Conclusion
The novel 0.014” fiber‐optic OptoWire™ provides superior wire handling with reduced risk of pressure drift allowing reliable pre‐ and post‐PCI physiology assessment.
Background Transapical aortic valve implantation (TAVI) for the treatment of severe aortic stenosis requires the insertion of a large catheter through the left ventricular apex. However, the ...electrocardiographic (ECG) changes associated with the incision and repair of the left ventricular apex and the potential damage to the conduction system caused by implanting a balloon-expandable valve in aortic position are not known. The objective of our study was to determine the incidence, type, and timing of ECG changes associated with TAVI. Methods The standard 12-lead ECGs of 33 consecutive patients (mean age 81 ± 9 years, 13 men) diagnosed with symptomatic severe aortic stenosis (valve area 0.62 ± 0.16 cm2 ) who underwent TAVI with an Edwards-SAPIEN valve were analyzed at baseline (within 24 hours before the procedure), immediately (within 6 hours) after the procedure, at hospital discharge, and at 1-month follow-up. Results There were no procedural deaths, and 30-day mortality was 6%. The incidence of complete left ventricular branch block (LBBB) and left anterior hemiblock (LAHB) increased from 9% and 3% at baseline to 27% and 36% after the procedure, respectively ( P < .03 for both). A lower (ventricular) position of the valve relative to the hinge point of the anterior mitral leaflet was associated with a higher incidence of new LBBB (35% vs 0%, P = .029); and a greater valve size–aortic annulus ratio, with the occurrence of new LAHB (1.20 ± 0.07 vs 1.14 ± 0.06, P = .021). At 1-month follow-up, the rate of LBBB and LAHB decreased to 13% and 10%, respectively ( P = not significant compared with baseline). There were no cases of new atrioventricular block, and no patient needed pacemaker implantation. Transient (<48 hours) ST-elevation changes, mostly in the anterior and/or lateral leads, occurred in 6 patients (18%) immediately after the procedure; but only 1 of these patients presented new Q waves at 1-month follow-up. Conclusions Transapical aortic valve implantation was associated with a significant but transient (<1 month) increase in LBBB and LAHB, with no patient requiring pacemaker implantation. These changes were partially related to both lower (more ventricular) valve positioning and greater valve oversizing. Transient (<48 hours) ST-segment elevation changes occurred in about one fifth of the patients after the procedure, but only a minority developed new Q waves in the ECG.
Targeting metabolic determinants of exercise performance with pharmacological agents that would mimic/potentiate the effects of exercise represents an attractive clinical alternative to ...counterbalance the poor exercise capacity in patients with type 2 diabetes mellitus (T2DM). We examined the effect of 1-yr treatment with the insulin sensitizer peroxisome proliferator-activated receptor (PPAR)γ agonist rosiglitazone on aerobic exercise capacity and body fat composition/distribution in men with T2DM and stable coronary artery disease (CAD). One-hundred four men (age: 64 ± 7 yr; body mass index: 30.0 ± 4.4 kg/m
) with T2DM and CAD were randomized to receive rosiglitazone or placebo for 1 yr. Aerobic exercise capacity (exercise duration) was assessed with a maximal treadmill test, and body composition/distribution were assessed by dual-energy X-ray absorptiometry/computed tomography scans. At 1 yr, patients with T2DM under PPARγ agonist treatment showed a reduction in aerobic exercise capacity compared with the control group (exercise duration change, -31 ± 8 versus 7 ± 11 s,
= 0.009). Significant increases in body fat mass (3.1 ± 0.4 kg, 12%), abdominal and mid-thigh subcutaneous adipose tissue (AT) levels, and mid-thigh skeletal muscle fat were found (all
< 0.01), whereas no effect on visceral AT levels was observed (
> 0.05) under treatment. Subcutaneous fat mass gained under PPARγ agonist was the strongest predictor of the worsening in aerobic exercise capacity (
> 0.0001); no association was found with skeletal muscle fat infiltration nor visceral AT. Treatment with the insulin sensitizer PPARγ agonist rosiglitazone in patients with T2DM and CAD is associated with a worsening in aerobic exercise capacity, which seems to be mainly attributable to weight gain and subcutaneous fat mass expansion.
Background The benefit of transradial access (TRA) in patients with cardiogenic shock (CS) is uncertain. We sought to determine the benefits of TRA in patients with CS undergoing coronary ...angiography/intervention. Methods MEDLINE, Embase, Cochrane Central, and electronic databases were searched for studies that assessed the following: (1) patients with CS who underwent percutaneous coronary intervention (PCI) and (2) the association between choice of arterial access, 30-day all-cause mortality, and 30-day major adverse cardiac and cerebral events (MACCEs) using random-effects model. Results From 3,652 retrieved citations, 8 studies involving 8,131 patients with CS undergoing PCI (via TRA: 2,321 patients, via TFA: 5,810 patients) were included. Transradial access was associated with significantly reduced risk for all-cause mortality (unadjusted: risk ratio RR 0.60, 95% CI 0.52-0.71, P < .001, I2 = 29%, 8 included studies; adjusted: RR 0.55, 95% CI 0.46-0.65, P < .001, I2 = 0%, 6 included studies) and MACCE (unadjusted: RR 0.68, 95% CI 0.63-0.73, P < .001, I2 = 0%, 6 included studies; adjusted: RR 0.63, 95% CI 0.52-0.75, P < .001, I2 = 0%, 4 included studies) at 30 days when compared with TFA. Conclusions Transradial access is associated with reduced mortality and MACCE at 30 days in patients with CS undergoing PCI. Considering the possible influence of selection bias on the effect estimate in our analysis, randomized controlled trials are needed to better assess this association.
The study aimed to evaluate inclacumab for the reduction of myocardial damage during a percutaneous coronary intervention (PCI) in patients with non-ST-segment elevation myocardial infarction.
...P-selectin is an adhesion molecule involved in interactions between endothelial cells, platelets, and leukocytes. Inclacumab is a recombinant monoclonal antibody against P-selectin, with potential anti-inflammatory, antithrombotic, and antiatherogenic properties.
Patients (N = 544) with non-ST-segment elevation myocardial infarction scheduled for coronary angiography and possible ad hoc PCI were randomized to receive 1 pre-procedural infusion of inclacumab 5 or 20 mg/kg or placebo. The primary endpoint, evaluated in patients who underwent PCI, received study medication, and had available efficacy data (n = 322), was the change in troponin I from baseline at 16 and 24 h after PCI.
There was no effect of inclacumab 5 mg/kg. Placebo-adjusted geometric mean percent changes in troponin I with inclacumab 20 mg/kg were -24.4% at 24 h (p = 0.05) and -22.4% at 16 h (p = 0.07). Peak troponin I was reduced by 23.8% (p = 0.05) and area under the curve over 24 h by 33.9% (p = 0.08). Creatine kinase-myocardial band yielded similar results, with changes of -17.4% at 24 h (p = 0.06) and -16.3% at 16 h (p = 0.09). The incidence of creatine kinase-myocardial band increases >3 times the upper limit of normal within 24 h was 18.3% and 8.9% in the placebo and inclacumab 20-mg/kg groups, respectively (p = 0.05). Placebo-adjusted changes in soluble P-selectin level were -9.5% (p = 0.25) and -22.0% (p < 0.01) with inclacumab 5 and 20 mg/kg. There was no significant difference in adverse events between groups.
Inclacumab appears to reduce myocardial damage after PCI in patients with non-ST-segment elevation myocardial infarction. (A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction Non-STEMI Undergoing Percutaneous Coronary Intervention; NCT01327183).
Purpose:
To compare the acute success and complication rates of distal radial (DR) vs proximal radial (PR) artery access for superficial femoral artery (SFA) interventions.
Materials and Methods:
...Between 2016 and 2019, 195 consecutive patients with symptomatic SFA stenosis were treated via DR (n=38) or PR (n=157) access using a sheathless guide. Secondary access was achieved through the pedal artery when necessary. The main outcomes were technical success, major adverse events (MAEs), and access site complications. Secondary outcomes were treatment success, fluoroscopy time, radiation dose, procedure time, and crossover rate to another puncture site.
Results:
Overall technical success was achieved in 188 patients (96.4%): 37 of 38 patients (97.3%) in the DR group and 151 of 157 patients (96.2%) in the PR group (p=0.9). Dual (transradial and transpedal) access was used in 14 patients (36.8%) in the DR group and 28 patients (18.9%) in the PR group (p<0.01). Chronic total occlusions were recanalized in 25 of 26 DR patients (96.1%) and in 79 of 81 PR patients (92.6%) (p=0.57). The crossover rate to femoral access was 0% in the DR group vs 3.2% in the PR group (p=0.59). Stents were implanted in the SFA in 15 DR patients (39.4%) and in 39 patients (24.8%) in the PR group (p=0.1). The contrast volume, fluoroscopy time, radiation dose, and procedure time were not statistically different between the DR and PR groups, nor were the rates of access site complications (2.6% and 7.0%, respectively). The cumulative incidences of MAE at 6 months in the DR and PR groups were 15.7% vs 14.6%, respectively (p=0.8).
Conclusion:
SFA interventions can be safely and effectively performed using PR or DR access with acceptable morbidity and a high technical success rate. DR access is associated with few access site complications.
Systematic use of coronary stents and optimized platelet aggregation inhibition has greatly improved the short-term results of percutaneous coronary interventions. Transradial percutaneous coronary ...interventions have been associated with a low risk of bleeding complications. It is unknown whether moderate- and high-risk patients can be discharged safely the same day after uncomplicated transradial percutaneous coronary interventions.
We randomized 1005 patients after a bolus of abciximab and uncomplicated transradial percutaneous coronary stent implantation either to same-day home discharge and no infusion of abciximab (group 1, n=504) or to overnight hospitalization and a standard 12-hour infusion of abciximab (group 2, n=501). The primary composite end point of the study was the 30-day incidence of any of the following events: death, myocardial infarction, urgent revascularization, major bleeding, repeat hospitalization, access site complications, and severe thrombocytopenia. The noninferiority of same-day home discharge and bolus of abciximab only compared with overnight hospitalization and abciximab bolus and infusion was evaluated. Two thirds of patients presented with unstable angina and approximately 20% presented with high-risk acute coronary syndrome prior to the procedure. The incidence of the primary end point was 20.4% in group 1 and 18.2% in group 2 (P=0.017 for noninferiority) with a troponin T-based definition of myocardial infarction; the incidence of the primary end point was 11.1% in group 1 and 9.6% in group 2 (P=0.0004 for noninferiority) with a creatinine kinase myocardial band-based definition of myocardial infarction. No death occurred. Rate of major bleeding in both groups was extremely low at 0.8% and 0.2%, respectively. From 504 patients randomized in group 1, 88% were discharged home the same day.
Our data suggest that same-day home discharge after uncomplicated transradial coronary stenting and bolus only of abciximab is not clinically inferior, in a wide spectrum of patients, to the standard overnight hospitalization and a bolus followed by a 12-hour infusion. This novel approach offers a safe strategy for same-day home discharge after uncomplicated coronary intervention.
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.
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.
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%).
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.
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