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Currently only the peripheral intravascular lithotripsy (IVL) device is approved for use in the United States. We queried the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database from January 1, 2016 to December 14, 2020 for all reports of adverse events and modes of failure related to the peripheral IVL device, when used for on- and off-label indications. There were 20 reports of use in peripheral artery disease interventions and 3 reports of off-label use in coronary interventions. Device malfunction in 13 of 23 patients (56.5%) was the most common adverse event reported. Partial balloon or catheter dislodgment was the most common mode of IVL device failure in 12 of 20 patients (60%), followed by balloon rupture in 3 of 20 patients (15%). Coronary use was rare, and associated with balloon perforation in 1 of 3 patients, bradycardia in 1 of 3 patients, and aortocoronary dissection in 1 of 3 patients. In summary, IVL use carries risk of complications; hence, continued vigilance and postmarketing monitoring are warranted.

Background There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions. Objectives We performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter vs. antegrade wire escalation for antegrade crossing of coronary chronic total occlusions. Methods The primary endpoints were: the time required to cross the chronic total occlusion or abort the procedure, and the frequency of procedural major adverse cardiovascular events. The secondary endpoints were: technical and procedural success, total procedure time, fluoroscopy time required to cross and total fluoroscopy time, total air kerma radiation dose, total contrast volume, and equipment utilization. Results Between 2015 and 2017, 246 patients were randomized to CrossBoss (n=122) or wire escalation (n=124) at 11 US centers. The baseline clinical and angiographic characteristics of the study groups were similar. Technical and procedural success were 87.8% and 84.1%, respectively and were similar in the two groups. Crossing time was similar: 56 (interquartile ranges: 33, 93) min in the CrossBoss and 66 (36, 105) min in the wire escalation group (p=0.323), as was as the incidence of procedural major adverse cardiovascular events (3.28% vs. 4.03%, p=1.000). There were no significant differences in the secondary study endpoints. Conclusions As compared with wire escalation, upfront use of the CrossBoss catheter for antegrade crossing of coronary chronic total occlusions was associated with similar crossing time, similar success and complication rates and similar equipment utilization and cost.

Objectives The aim of this study was to develop a hybrid approach–specific model to predict chronic total coronary artery occlusion (CTO) percutaneous coronary intervention success, useful for experienced but not ultra-high-volume operators. Background CTO percutaneous coronary intervention success rates vary widely and have improved with the “hybrid approach,” but current predictive models for success have major limitations. Methods Data were obtained from consecutively attempted patients from 7 clinical sites (9 operators, mean annual CTO volume 61 ± 17 cases). Angiographic analysis of 21 lesion variables was performed centrally. Statistical modeling was performed on a randomly designated training group and tested in a separate validation cohort. The primary outcome of interest was technical success. Results A total of 436 patients (456 lesions) met entry criteria. Twenty-five percent of lesions had prior failed percutaneous coronary interventions at the site. The right coronary artery was the most common location (56.4%), and mean occlusion length was 24 ± 20 mm. The initial approach was most often antegrade wire escalation (70%), followed by retrograde (22%). Success was achieved in 79.4%. Failure was most closely correlated with presence of an ambiguous proximal cap, and in the presence of an ambiguous proximal cap, specifically defined collateral score (combination of Werner and tortuosity scores) and retrograde tortuosity. Without an ambiguous proximal cap, poor distal target, occlusion length >10 mm, ostial location, and 1 operator variable contributed. Prior failure, and Werner and tortuosity scores alone, were only weakly correlated with outcomes. The basic 7-item model predicted success, with C statistics of 0.753 in the training cohort and 0.738 in the validation cohort, the later superior (p Conclusions Success can be reasonably well predicted, but that prediction requires modification and combination of angiographic variables. Differences in operator skill sets may make it challenging to create a powerful, generalizable, predictive tool.

The study aim was to assess the effect of hourglass-shaped V8 and TAV8 balloons (InterValve, Inc) on aortic valve area (AVA) and other outcomes in patients with severe aortic stenosis undergoing balloon aortic valvuloplasty (BAV). BAV has re-emerged with transcatheter therapy. Cylindrical balloons have been the device of choice despite limitations. The hourglass-shaped balloons, with shorter, broader segments separated by a narrowed waist, permit enhanced fixation and better leaflet opening without annular or sinotubular compromise.We compared outcomes of InterValve balloon use in patients undergoing BAV with outcomes of cylindrical balloon use in patients from a BAV database. Patients were propensity matched by age, gender, baseline AVA, left ventricular ejection fraction, and Society of Thoracic Surgeons mortality risk score. Endpoints included change in AVA and aortic insufficiency (AI) by echocardiography, new permanent pacemaker (PPM) implantation, and major adverse events (ie, procedural death, emergency surgery, or stroke).Forty InterValve balloon patients were matched with 40 cylindrical balloon patients. Postprocedure change in AVA trended strongly in favor of InterValve balloon patients (0.29 ± 0.17 cm² vs 0.22 ± 0.15 cm²; P=.06). Maximum balloon sizes were significantly smaller for InterValve balloon patients. Worsened AI occurred less frequently with InterValve balloons. There was no difference in postprocedure PPM implantations or major adverse events.Use of the hourglass-shaped balloons provided larger AVA, as compared with use of cylindrical balloons. Use of the novel balloons was not associated with an increase in AI, PPM, or major adverse events.

The authors performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter versus antegrade wire escalation for antegrade crossing of coronary chronic total occlusions.There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions.The primary endpoints were the time required to cross the chronic total occlusion or abort the procedure and the frequency of procedural major adverse cardiovascular events. The secondary endpoints were technical and procedural success, total procedure time, fluoroscopy time required to cross and total fluoroscopy time, total air kerma radiation dose, total contrast volume, and equipment use.Between 2015 and 2017, 246 patients were randomized to the CrossBoss catheter (n = 122) or wire escalation (n = 124) at 11 U.S. centers. The baseline clinical and angiographic characteristics of the study groups were similar. Technical and procedural success were 87.8% and 84.1%, respectively, and were similar in the 2 groups. Crossing time was similar: 56 min (interquartile range: 33 to 93 min) in the CrossBoss group and 66 min (interquartile range: 36 to 105 min) in the wire escalation group (p = 0.323), as was as the incidence of procedural major adverse cardiovascular events (3.28% vs. 4.03%; p = 1.000). There were no significant differences in the secondary study endpoints.As compared with wire escalation, upfront use of the CrossBoss catheter for antegrade crossing of coronary chronic total occlusions was associated with similar crossing time, similar success and complication rates, and similar equipment use and cost.

The aim of this study was to develop a hybrid approach-specific model to predict chronic total coronary artery occlusion (CTO) percutaneous coronary intervention success, useful for experienced but not ultra-high-volume operators.CTO percutaneous coronary intervention success rates vary widely and have improved with the "hybrid approach," but current predictive models for success have major limitations.Data were obtained from consecutively attempted patients from 7 clinical sites (9 operators, mean annual CTO volume 61 ± 17 cases). Angiographic analysis of 21 lesion variables was performed centrally. Statistical modeling was performed on a randomly designated training group and tested in a separate validation cohort. The primary outcome of interest was technical success.A total of 436 patients (456 lesions) met entry criteria. Twenty-five percent of lesions had prior failed percutaneous coronary interventions at the site. The right coronary artery was the most common location (56.4%), and mean occlusion length was 24 ± 20 mm. The initial approach was most often antegrade wire escalation (70%), followed by retrograde (22%). Success was achieved in 79.4%. Failure was most closely correlated with presence of an ambiguous proximal cap, and in the presence of an ambiguous proximal cap, specifically defined collateral score (combination of Werner and tortuosity scores) and retrograde tortuosity. Without an ambiguous proximal cap, poor distal target, occlusion length10 mm, ostial location, and 1 operator variable contributed. Prior failure, and Werner and tortuosity scores alone, were only weakly correlated with outcomes. The basic 7-item model predicted success, with C statistics of 0.753 in the training cohort and 0.738 in the validation cohort, the later superior (p 0.05) to that of the J-CTO (Multicenter CTO Registry of Japan) (0.55) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) (0.61) scores.Success can be reasonably well predicted, but that prediction requires modification and combination of angiographic variables. Differences in operator skill sets may make it challenging to create a powerful, generalizable, predictive tool.

In patients with hibernating myocardium, regional uptake of the glucose analog 2-fluorine 18-fluoro-2-deoxy-d-glucose (FDG) is increased under resting conditions. It is unclear whether the degree of increased FDG uptake correlates with the degree of impaired blood flow response and whether chronic changes in the glucose transporters may play a role in the enhanced FDG uptake under fasted conditions.Twelve swine were instrumented with a constrictor on the left anterior descending (LAD) artery. Serial echocardiography and positron emission tomography studies were done to assess temporal changes in myocardial function, blood flow, and FDG uptake. One week after surgery (early study), wall thickening, blood flow, and postdobutamine FDG uptake in LAD and remote territories were similar. By approximately 6 weeks (late study), baseline wall thickening in the LAD region was lower than in remote regions (20% +/- 7% and 36% +/- 6%, P.05), as was dobutamine-stimulated blood flow (0.92 +/- 0.16 mL. min(-1). g(-1) and 1.17 +/- 0.20 mL. min(-1). g(-1) in LAD and remote regions, respectively; P.05). After the dobutamine infusion, FDG uptake in the LAD region during fasted conditions was higher than in remote regions (0.128 +/- 0.053 micromol. min(-1). g(-1) and 0.098 +/- 0.044 micromol. min(-1). g(-1), respectively; P.05), and the increase was proportional to the impairment in dobutamine blood flow (r(2) = 0.62, P.001). After the animals were killed, the LAD region showed a higher content of GLUT4 by immunoblots and a greater degree of translocation as estimated by immunohistochemistry. In 5 additional hibernating pigs studied under resting fasted conditions, FDG uptake and GLUT4 translocation were also higher in the LAD region, in the absence of dobutamine stimulation.In hibernating myocardium, regional FDG uptake under fasting conditions is higher than in remote regions, both at rest and after an infusion of dobutamine. The degree of poststress FDG uptake is proportional to the impaired stress-induced blood flow. Total GLUT4 content as well as membrane-bound protein is higher in the hibernating tissue, and these changes may facilitate the observed increase in FDG uptake.

Chronic total occlusion (CTO)s are common and often result in referral for bypass surgery without attempted PCI. When PCI is attempted, success rates are variable and current predictive models for success have major limitations. We sought to develop a hybrid approach-specific model to predict CTO

Background— Cocaine abuse has been implicated in multiple cardiovascular complications. Coronary artery aneurysms (CAAs) and ectasia occur in 0.2% to 5.3% of patients referred for angiography and are associated with atherosclerosis, Kawasaki’s disease, and several rare disorders. After observing CAAs in multiple young cocaine users, we investigated the prevalence of CAAs among cocaine users undergoing coronary angiography. Methods and Results— Clinical and angiographic characteristics of 112 consecutive patients with a history of cocaine use and coronary angiography were compared with a control group of similar age and risk factors from an existing angiographic database over the same time period. Coronary angiograms were independently read by 3 reviewers blinded to cocaine use. Cocaine users were young (mean age, 44 years), predominantly male (80%), and cigarette smokers (95%). Control patients had higher rates of diabetes (33%) and more severe coronary artery disease ( P =0.01). Previous myocardial infarction was common in both groups (45% of cocaine users, 38% of control patients). Despite the frequent history of myocardial infarction among cocaine users, 48% had nonobstructive coronary artery disease. Among cocaine users, 34 of 112 (30.4%) had CAAs compared with 6 of 79 (7.6%) in the control group ( P Conclusions— This is the first description of an association between cocaine use and CAA. The prevalence of CAA among cocaine users was higher than expected (30.4%), given such a young cohort. Cocaine use may predispose to the formation of CAA, which may in turn be a contributing factor to myocardial infarction.

The goal of this study was to determine whether myocardial glucose uptake after repetitive ischemia differs in response to coronary occlusion-reperfusion versus supply-demand ischemia induced by dobutamine. Although glucose metabolism is increased after myocardial ischemia, the metabolic effect of supply-demand ischemia induced by dobutamine may increase glucose metabolism within remote myocardium. This would make it difficult to discriminate postischemic from remote myocardium with glucose tracers.Eighteen swine with a hydraulic occluder and flow probe on the circumflex artery underwent repetitive ischemia. In group 1 (n = 9), the circumflex artery was occluded, whereas in group 2 (n = 9), circumflex flow was decreased by 30% before dobutamine (40 micro g/kg/min intravenously). Each pig underwent 15 min of ischemia, twice per day for 5 d. Echocardiography and PET to determine myocardial glucose ((18)F-FDG) uptake were performed after final ischemia, and tissue was later analyzed for activation of Akt, p38 mitogen-activated protein, and adenosine monophosphate (AMP) kinase.Wall thickening in the circumflex region was lower than in remote regions in both groups. (18)F-FDG uptake in the circumflex region was similar in groups 1 and 2 (0.22 +/- 0.03 and 0.23 +/- 0.04 micro mol/min/g, respectively; not statistically significant). In the remote region, (18)F-FDG uptake was lower than in the circumflex region in group 1 (0.14 +/- 0.03 micro mol/min/g; P0.05) but was similar to that in the circumflex region in group 2 (0.20 +/- 0.03 micro mol/min/g; not statistically significant). AMP kinase activity in the remote region was significantly lower than in the circumflex region in group 1 but was similar to that in the circumflex region in group 2.Unlike repetitive coronary artery occlusion-reperfusion, repetitive supply-demand ischemia with dobutamine alters glucose uptake within the remote myocardium, possibly as a result of AMP kinase activation. Clinically, these data suggest that (18)F-FDG studies have a limited role in discriminating postischemic from remote myocardium after dobutamine stress.

Repetitive myocardial ischemia increases glucose uptake, but the effect on glycogen is unclear. Thirteen swine instrumented with a hydraulic occluder on the circumflex (Cx) artery underwent 10-min occlusions twice per day for 4 days. After 24 h postfinal ischemia and in the fasted state, echocardiogram and positron emission tomography imaging for blood flow ([13N]-ammonia) and 2-[18F]fluoro-2-deoxy-d-glucose (FDG) uptake were obtained. Tissue was then collected for ATP, creatine phosphate (CP), glycogen, and glucose transporter-4 content, and hexokinase activity. After reperfusion, regional function and CP-to-ATP ratios in the Cx and remote regions were similar. Despite the absence of stunning, the Cx region demonstrated higher glycogen levels (33 ± 11 vs. 24 ± 11 μmol/g; P < 0.05), and this increase correlated well with the increase in FDG uptake ( r2= 0.78; P < 0.01). Hexokinase activity was also increased relative to remote regions (0.62 ± 0.29 vs. 0.37 ± 0.19 IU/g; P < 0.05), with no difference in GLUT-4 content. In summary, 24 h after repetitive ischemia, glucose uptake and glycogen levels are increased at a time that functional and bioenergetic markers of stunning have recovered. The significant correlation between glycogen content and FDG accumulation in the postischemic region suggests that increased rates of glucose transport and/or phosphorylation are linked to increased glycogen levels in hearts subjected to repetitive bouts of ischemia.