How to limit radial artery spasm during percutaneous coronary interventions: The spasmolytic agents to avoid spasm during transradial percutaneous coronary interventions (SPASM3) study.

AIMS: To compare the efficacy of three vasodilators in preventing radial artery spasm (RAS) in patients undergoing transradial percutaneous coronary interventions (PCI). METHODS AND RESULTS: 731 patients were randomized to receive diltiazem 5 mg, verapamil 2.5 mg, or isosorbide dinitrate (ISDN) 1 mg before coronary intervention. RAS occurred in 20.1% in the whole population and was significantly reduced by verapamil and ISDN compared to diltiazem (16.2, 17.2, and 26.6%, respectively; P < 0.006). There was also a trend towards less severe pain (more than 8 on a numerical scale from 0 [no pain] to 10 [maximal pain]), and less severe RAS (complete catheter blockage or severe pain), among patients treated by verapamil compared to ISDN and diltiazem (1.3% vs. 2.8% vs. 2.9%, P = 0.43 and 5.1% vs. 6.2% vs. 9.5%, respectively, P = 0.13). No difference was found between the three vasodilators in terms of crossover or safety events. Female gender, failure at first attempt to access the radial artery, emergency procedures, and the use of diltiazem were independent predictors of RAS. CONCLUSION: Verapamil and ISDN considerably reduce the incidence of RAS compared to diltiazem during transradial PCI.

Abnormal epicardial coronary vasomotor reactivity is associated with altered outcomes.

BACKGROUND: The prevalence and significance of abnormal epicardial coronary vasomotor reactivity (ACVR) in patients with symptoms compatible with myocardial ischaemia remains ill-defined. Our diagnostic strategy is to perform a provocative test (PT) in every patient presenting with chest pain at rest, for whom coronary angiography does not reveal significant epicardial coronary artery disease (≥70% stenosis by visual assessment). AIM: To evaluate such a strategy in terms of incidence of ACVR, PT safety and patient outcomes. METHODS: The present study was a retrospective observational study with a median clinical follow-up of 5years. The primary outcome was incidence of ACVR in patients with PT. Risk factors for ACVR and clinical follow-up were obtained, and the rate of major adverse cardiovascular and cerebrovascular events (MACCE; death, cardiovascular mortality, myocardial infarction, stroke and coronary revascularization) was reported. RESULTS: ACVR was documented in 294 (12.4%) of the 2379 patients with PT, out of the 13,654 patients undergoing angiography. Patients with ACVR were more often female (43.9% vs. 30.0%; P<0.0001), current smokers (37.4% vs. 8.7%; P<0.0001) and had a suspected acute coronary syndrome (36.7% vs. 29.1%; P=0.005) at admittance compared with patients without ACVR. During clinical follow-up, MACCE occurred more frequently in patients with (9.8%) than in those without (3.7%) ACVR (hazard ratio [HR] 4.15, 95% confidence interval [CI] 2.62-6.57; P<0.0001), including more myocardial infarctions (4.0% vs. 0.4%; HR 17.8, 95% CI 6.41-49.5; P<0.0001) and more myocardial revascularizations (6.1% vs. 1.1%; HR 9.36, 95% CI 4.67-18.74; P<0.0001) compared with patients with normal PT at baseline. CONCLUSIONS: ACVR is frequent in patients with symptoms compatible with myocardial ischaemia at rest, with no significant coronary stenosis. PT is a safe strategy to identify a population at high risk of recurrent ischaemic events.

B-CONVINCED: Beta-blocker CONtinuation Vs. INterruption in patients with Congestive heart failure hospitalizED for a decompensation episode.

AIMS: Whether or not beta-blocker therapy should be stopped during acutely decompensated heart failure (ADHF) is unsure. METHODS AND RESULTS: In a randomized, controlled, open labelled, non-inferiority trial, we compared beta-blockade continuation vs. discontinuation during ADHF in patients with LVEF below 40% previously receiving stable beta-blocker therapy. 169 patients were included, among which 147 were evaluable. Mean age was 72 +/- 12 years, 65% were males. After 3 days, 92.8% of patients pursuing beta-blockade improved for both dyspnoea and general well-being according to a physician blinded for therapy vs. 92.3% of patients stopping beta-blocker. This was the main endpoint and the upper limit for unilateral 95% CI (6.6%) is lower that of the predefined upper limit (12.5%), indicating non-inferiority. Similar findings were obtained at 8 days and when evaluation was made by the patient. Plasma BNP at Day 3, length of hospital stay, re-hospitalization rate, and death rate after 3 months were also similar. Beta-blocker therapy at 3 months was given to 90% of patients vs. 76% (P < 0.05). CONCLUSION: In conclusion, during ADHF, continuation of beta-blocker therapy is not associated with delayed or lesser improvement, but with a higher rate of chronic prescription of beta-blocker therapy after 3 months, the benefit of which is well established.

Comparison of TransFemoral Transcatheter Aortic Valve Replacement Performed With a Minimally Invasive Simplified Technique: "FAST" Versus a Standard Approach.

OBJECTIVES: To assess the safety and efficacy of a new simplified procedure for transfemoral (TF) transcatheter aortic valve replacement (TAVR): the FAST protocol. BACKGROUND: A minimalist approach for TF-TAVR has been reported. The goal of this simplified strategy is to reduce the rate of specific complications associated with general anesthesia, second vascular access, and use of temporary pacemaker, and to reduce the length of stay. METHODS: We retrospectively reviewed all TF-TAVR cases performed at our center between January 2015 and December 2017. The FAST strategy consisted of local anesthesia with conscious sedation, echocardiographically guided TF puncture for main vascular access, radial approach for secondary arterial access, and left ventricular guidewire rapid pacing. Patients were sorted according to the initial strategy (FAST vs standard). The primary outcome was an early safety composite outcome including all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication, and valve-related dysfunction. RESULTS: A total of 285 consecutive patients were included in the present analysis (76 FAST patients and 209 standard patients). There were no baseline differences between groups. Complete FAST procedure was feasible in 83.0% of cases and all FAST procedures were successful. The primary outcome was significantly lower in the FAST group (1.3% vs 14.3%; P<.001). The use of FAST protocol resulted in a reduction of major bleeding (1.3% vs 10.1%; P=.01), blood transfusion (2.6% vs 14.3%; P<.01), and vascular complications related to the secondary access (0.0% vs 5.3%; P=.04). The length of stay was also significantly lower in the FAST group (4.9 days vs 6.4 days; P<.01). CONCLUSIONS: FAST can be safely performed and is associated with lower rates of iatrogenic complications and a shorter length of stay.

Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited. OBJECTIVES: The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period. METHODS: TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers. RESULTS: A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased. CONCLUSIONS: The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828).

Impact of an extension tube on operator radiation exposure during coronary procedures performed through the radial approach.

BACKGROUND: Operator radiation exposure is high during coronary procedures. The radial access decreases the rate of local vascular complications but increases operator radiation exposure. As the X-ray exposure is related to the distance between the operator and the radiation source, the use of an extension tube between the proximal part of the coronary catheter and the 'injection device' might decrease operator radiation exposure. AIMS: To demonstrate that the use of an extension tube during coronary procedures performed through the radial approach decreases operator radiation. METHODS: Overall, 230 patients were included consecutively and randomized to procedures performed with or without an extension tube. Radiation exposure measures were obtained using two electronic dosimeters, one under the lead apron and the other exposed on the physician's left arm. RESULTS: A non-significant trend towards lower left-arm operator exposure was noted in the extension tube group (28.7+/-31.0microSv vs 38.4+/-44.2microSv, p=0.0739). No significant difference was noted according to the type of procedure. Radiation levels were low compared with the series published previously and decreased for each operator during the study. CONCLUSION: The use of an extension tube did not reduce operator radiation exposure during procedures performed through the radial approach. However, physician awareness was increased during the study due to the use of an exposed electronic dosimeter. The use of exposed electronic dosimeters could therefore be recommended to allow operators to improve their protection techniques.

Prevention of arterial spasm during percutaneous coronary interventions through radial artery: the SPASM study.

AIMS: Radial artery spasm remains the major limitation of transradial approach for percutaneous coronary interventions. The aim of our study was to evaluate the efficacy of vasodilators in the prevention of radial artery spasm during percutaneous coronary interventions. METHODS AND RESULTS: 1,219 patients were consecutively randomized to receive placebo (n = 198), molsidomine 1 mg (n = 203), verapamil 2.5 mg (n = 409), 5 mg (n = 203) or verapamil 2.5 mg and molsidomine 1 mg (n = 206). All drugs were administered through the arterial sheath. The primary end point was the occurrence of a radial artery spasm defined by the operator as severe limitation of the catheter movement, with or without angiographic confirmation. Main characteristics including age, sex, wrist and arterial sheath diameters and procedure duration were identical across the groups. The rate of radial artery spasm was lowest in patients receiving verapamil and molsidomine (4.9%), compared to verapamil 2.5 mg or 5 mg (8.3 and 7.9%), or molsidomine 1 mg (13.3%); and placebo (22.2%) (P < 0.0001). CONCLUSION: Radial artery spasm during transradial percutaneous interventions was effectively prevented by the administration of vasodilators. The combination of verapamil 2.5 mg and molsidomine 1 mg provided the strongest relative risk reduction of spasm compared to placebo and should therefore be recommended during percutaneous coronary interventions through the radial approach.