Radial artery access technique evaluation trial: randomized comparison of Seldinger versus modified Seldinger technique for arterial access for transradial catheterization.

BACKGROUND: Radial artery access for transradial catheterization is obtained using either Seldinger or modified Seldinger technique. There is no comparative evaluation of the safety and benefits of these two techniques. METHODS: Four hundred twelve patients undergoing transradial catheterization were randomized to group I (n = 210) Seldinger technique, and group II (n = 202) modified Seldinger technique. Demographic and procedural data were collected at the time of the procedure. Data on hematoma and radial artery occlusion (RAO) were recorded at 24 hr and 30 days after the procedure. RESULTS: Age, gender, weight, height, and history of diabetes mellitus were comparable between groups I and II. Access time (78.3 ± 37.7 sec vs. 134.2 ± 87.5 sec, P < 0.001), procedure time (17.1 ± 6.4 min vs. 19.3 ± 7.1 min, P < 0.01), number of attempts to get access (1.7 ± 0.8 vs. 2.2 ± 0.8, P < 0.001), were significantly different favoring group I. Access was obtained at first attempt in 53% of patients in group I compared with 16% in group II (P < 0.001). Change in technique (crossover) was required in 10.8% of group II patients, compared with no crossover in group I (P < 0.0001). Incidence of hematoma (0.5% vs. 1.5%, P > 0.2) and 30-day RAO (4.3% vs. 3.9 %, P > 0.5) was similar between groups I and II. CONCLUSIONS: Seldinger technique is a faster and more predictable radial artery access technique compared with modified Seldinger technique with no increase in bleeding or RAO.

Trends in Usage and Clinical Outcomes of Coronary Atherectomy: A Report From the National Cardiovascular Data Registry CathPCI Registry.

BACKGROUND: Adjunctive coronary atherectomy (CA) can be utilized in treating severely calcified coronary lesions; however, the temporal trends, patient selection, and variation in use of CA have not been well described. We sought to assess the trends in usage, interhospital variability, and outcomes with CA among patients undergoing percutaneous coronary intervention (PCI). METHODS: All patients undergoing PCI in the National Cardiovascular Data Registry CathPCI Registry from July 1, 2009 to December 31, 2016 (N=3 864 377) were analyzed based on utilization of either rotational or orbital CA. Intervals using date of index CA grouped into 2009 Q3 to 2010, 2011 to 2012, 2013 to 2014, and 2015 to 2016 and hospital-level quartiles based on annual CA volumes were evaluated. The primary outcome measure was in-hospital major adverse cardiac events defined as a composite of all-cause mortality, periprocedural myocardial infarction, or stroke. Independent variables associated with outcomes were determined. RESULTS: CA represented 1.7% (n=65 033) of the total PCI volume. Among hospitals performing PCI (n=1672), 577 (34.5%) did not perform any CA. Patients treated with CA were elderly, more often male, and had a history of diabetes, prior myocardial infarction, PCI, and coronary artery bypass grafting. The utilization of CA increased from 1.1% in Q3 2009 to 3.0% in Q4 of 2016 (5% quarterly increase in odds of CA; OR [95% CI], 1.05 [1.04-1.06], P<0.001). Among patients undergoing CA, there was a temporal decline in major adverse cardiac events (0.98 [0.97-0.99], P<0.001) and myocardial infarction (0.97 [0.96-0.98], P<0.001). In adjusted analyses, increasing hospital CA volume was associated with lower mortality (0.85 [0.76-0.96], P=0.01) and lower rates of PCI failure or complication requiring coronary artery bypass grafting (0.67 [0.56-0.79], P<0.001) but was associated with small increase in coronary perforation (1.18 [1.04-1.35], P<0.01). CONCLUSIONS: Although CA is performed infrequently, its use has increased over time. After accounting for potential confounders, higher CA volume was associated with lower risk of major adverse events counterbalanced by small risk of coronary perforation.

Effect of hemostatic device on radial artery occlusion: A randomized comparison of compression devices in the radial hemostasis study.

BACKGROUND: Asymptomatic radial artery occlusion (RAO) is a major limitation of transradial catheterization (TRC). Two radial compression hemostatic devices are compared for their respective effects on RAO. METHODS: In a prospective, randomized, single center, blinded trial, 320 patients were randomly treated with a TR band (Terumo Corporation) or Safeguard Radial (Merit Medical). Institution wide protocols consisting of anticoagulation, patent hemostasis, duration of compression, and use of 6 French slender sheaths (Terumo Corporation) were observed. Patient discomfort related to the device was recorded using the universal pain scale. Radial artery patency was evaluated by reverse Barbeau's test prior to discharge (1-hour post-diagnostic catheterization or 6-24 hour post-intervention) and at 30-days. RESULTS: Of the 320 patients, 155 were randomized to the TR group (TRG) and 159 to the Safeguard group (SGG). 6 patients were excluded due to the inability to insert 6 Fr slender sheaths or patient withdrawing consent. Demographic and procedural characteristics were similar with the exception of the type of coronary procedure performed. Both bands were equally effective in achieving patent hemostasis. Despite having a higher rate of post-procedure hematoma (1.29% TRG vs. 3.1% SGG, p = 0.04) and acute RAO (3.8% TRG vs. 6.28% SGG, p = 0.05) with the Safeguard band, at 30 days RAO was similar in both groups (1.9% TRG vs. 2.5% SGG; p = 0.21). Patients in the SGG reported significantly less band discomfort and were found to require less air to achieve patent hemostasis. CONCLUSION: Evidence-based contemporary TRC protocols of using smaller diameter access, anticoagulation, and use of just enough pressure for the shortest duration of time to achieve hemostasis is associated with very low RAO rate at 30 days irrespective of the radial compression device used.

Retrograde Tibio-Pedal Access for Revascularization of Lower-Extremity Peripheral Artery Disease Using a 6 Fr Slender Sheath: The "Pedal-First" Pilot Project.

OBJECTIVE: We studied the safety and efficacy of tibio-pedal access (TPA) as the sole primary access (ie, the "pedal-first" strategy) for revascularization of peripheral artery disease (PAD). METHODS: We reviewed a prospectively maintained database of patients where TPA was used as a primary access for retrograde diagnostic angiography and intervention. Patients suffering from symptomatic PAD and abnormal non-invasive testing were treated with the intention of using only ipsilateral TPA if there was antegrade flow in one of the three run-off vessels on ultrasound (US). Additional radial or femoral access (FA) was used only if needed for successful revascularization. TPA was achieved with US guidance using a 6 Fr thin-walled hydrophilic sheath. Patency of the accessed tibio-pedal artery was evaluated with US at 30 days. RESULTS: The pedal-first approach was attempted for 41 limbs in 36 patients. The overall rate of successful revascularization was 95% (39 limbs). TPA was successfully used in all 39 limbs and "pedal-only" success occurred in 30 limbs (77%). Two procedures were unsuccessful in revascularizing target-vessel occlusion despite dual access. Patients without FA were able to ambulate at an average of 3 hours post procedure. No acute vascular access-related complications were noted. Each accessed tibio-pedal artery was patent on US evaluation at 30 days. CONCLUSION: The pedal-first approach of using TPA with a 6 Fr thin-walled sheath as a primary access and as the only access for diagnosis and intervention of PAD is safe and highly successful in carefully selected patients.

Randomized Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions: The CrossBoss First Trial.

OBJECTIVES: 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. BACKGROUND: There is equipoise about the optimal initial strategy for crossing 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 use. RESULTS: 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. 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 use and cost.