Impact of the number of modifiable risk factors on clinical outcomes after percutaneous coronary intervention: An analysis from the e-Ultimaster registry.

Aims: A substantial proportion of the patients undergoing percutaneous coronary intervention (PCI) have none of the of standard modifiable cardiovascular risk factors (SMuRFs): hypertension, diabetes, hypercholesterolaemia and smoking. The aim of this analysis was to compare clinical outcomes after PCI according to the number of SMuRFs. Methods: Patients with an indication for a PCI were stratified based upon the number of SMuRFs: 0, 1, 2 or 3-4. The primary outcome was target lesion failure (TLF), a composite of cardiac death, target vessel-related myocardial infarction or clinically driven target lesion revascularization at 1-year. Inverse weighted propensity score (IWPS) adjustment was performed to adjust for differences in baseline characteristics. Results: The prevalence of SMuRFs was: 0 SMuRF 16.4 %; 1 SMuRF 27.8 %; 2 SMuRFs 34.7 % and 3-4 SMuRFs 21.1 %. Patients without SMuRFs were younger, more likely to be male and had less complex coronary artery disease. The incidence of TLF increased with the number of SMuRFs: 2.65 %, 2.75 %, 3.23 %, and 4.24 %, Ptrend < 0.001. The relative risk (RR) for a TLF was 60 % higher (95 % confidence interval 1.32-1.93, p < 0.01) for patients with 3-4 SMuRFs compared to patients without SMuRFs. The trend remained (Ptrend < 0.01) after IWPS with TLF rates of 2.88 %, 2.64 %, 2.88 % and 3.65 %. The RR for a TLF was 27 % higher (95 % CI 1.05-1.53, p < 0.01). Conclusion: The incidence of clinical events at 1-year increased with the number of SMuRFs. While patients without SMuRFs have a relatively favourable risk profile, more research is needed to optimize therapeutic management in the majority of patients.

Direct wire pacing during measurement of fractional flow reserve: A randomized proof-of-concept noninferiority crossover trial.

Background: Adenosine administration for fractional flow reserve (FFR) measurement may induce heart pauses. Aims: To assess the accuracy and tolerability of direct wire pacing (DWP) during measurement of FFR. Methods: Adults with at least one intermediate coronary artery stenosis (40%-80%) were consecutively enrolled between June 2021 and February 2022 in this randomized, noninferiority, crossover trial (NCT04970082) carried out in France. DWP was applied (DWP) or not (standard method) through the pressure guidewire used for FFR measurement during adenosine-induced maximal hyperaemia. Subjects were randomly assigned to the allocation sequence (DWP first or standard first). A 2-minute washout period was observed between the two FFR measurements performed for each stenosis. The primary endpoint was the reproducibility of FFR measurements between methods. Results: A total of 150 focal lesions, presented by 94 subjects, were randomized (ratio: 1:1). The FFR values obtained with each method were nearly identical (R = 0.98, p = 0.005). The mean FFR difference of 0.00054 (95% confidence interval: 0.004 to 0.003) showed the noninferiority of FFR measurement with DWP vs. that with the standard method. Higher levels of chest discomfort were reported with DWP than with the standard method (0.61 ± 0.84 vs. 1.05 ± 0.89, p < 0.001), and a correlation was observed between the electrical sensations reported with DWP and chest discomfort (p < 0.001). Pauses (n = 20/148 lesions) were observed with the standard method, but did not correlate with chest discomfort (p = 0.21). No pauses were observed with DWP. Conclusions: DWP during FFR measurement resulted in accurate and reproducible FFR values, and eliminated the pauses induced by adenosine.

Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation. BACKGROUND: Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR). METHODS: This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days. RESULTS: Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001). CONCLUSIONS: Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896).

Radiation Doses to Patients in Interventional Coronary Procedures-Estimation of Updated National Reference Levels by Dose Audit.

The objective of this study was to estimate the French national updated reference levels (RLs) for coronary angiography (CA) and percutaneous coronary intervention (PCI) by a dose audit from a large data set of unselected procedures and in standard-sized patients. Kerma-area product (PKA), air kerma at interventional point (Ka,r), fluoroscopy time (FT), and the number of registered frames (NFs) and runs (NRs) were collected from 51 229 CAs and 42 222 PCIs performed over a 12-month period at 61 French hospitals. RLs estimated by the 75th percentile in CAs and PCIs performed in unselected patients were 36 and 78 Gy.cm² for PKA, 498 and 1285 mGy for Ka,r, 6 and 15 min for FT, and 566 and 960 for NF, respectively. These values were consistent with the RLs calculated in standard-sized patients. The large difference in dose between sexes leads us to propose specific RLs in males and females. The results suggest a trend for a time-course reduction in RLs for interventional coronary procedures.

Patient exposure to X-rays during coronary angiography and percutaneous transluminal coronary intervention: results of a multicenter national survey.

OBJECTIVES: To evaluate practices for the protection from radiation of patients during coronary angiography (CA) and percutaneous coronary intervention (PCI), and to update reference values for the main radiation dose parameters. BACKGROUND: Few multicenter data from large populations exist on radiation doses to patients during CA and PCI. METHODS: RAY'ACT is a multicenter, nationwide French survey, with retrospective analysis of radiation parameters routinely registered in professional software from 33,937 CAs and 27,826 PCIs performed at 44 centers from January 1, through December 31, 2010. RESULTS: Kerma-area product (KAP) was registered in 91.7% (44/48) of centers and in 91.5% of procedures for CA (median, 27.2 Gy·cm(2) , interquartile range [IQR], 15.5-45.2) and 91.1% for PCI (median, 56.8 Gy·cm(2) , IQR, 32.8-94.6). Fluoroscopy time was registered in 87.5% (42/48) of centers and in 83.1% of procedures (median, 3.7 min, IQR, 2.3-6.3 for CA; 10.3 min, 6.7-16.2 for PCI). Variability across centers was high. Old equipment and routine left ventriculography were more common and number of registered frames and frame rate were higher in centers delivering high doses. The radial route was associated with lower doses than the femoral route (median KAP 26.8 Gy·cm(2) [15.1-44.25] vs. 28.1 [16.4-46.9] for CA, respectively; and 55.6 Gy·cm(2) [32.2-92.1] vs. 59.4 [24.6-99.9] for PCI, respectively; P < 0.01). CONCLUSIONS: This survey showed a very high rate of compliance with dose registration during CA and PCI in French nonacademic hospitals. Updated diagnostic reference values are established for the main dose parameters (KAP, 45 Gy·cm(2) for CA, 95 Gy·cm(2) for PCI).

Predictive factors of cardiac events after implantation of sirolimus-eluting stents for treatment of in-stent restenosis.

BACKGROUND: The factors associated with recurrent restenosis after SES implantation for in-stent restenosis are unknown. This study aimed to assess the clinical outcome and to analyse predictive factors of cardiac events in patients with in-stent restenosis treated with Sirolimus-eluting stent (SES). METHODS: In 3 centers, consecutive patients (n = 100) with elective indication to percutaneous coronary intervention (PCI) for in-stent restenosis (n = 110) were treated with SES: 28 lesions were focal, 40 diffuse, 17 proliferative, and 15 showed total occlusion. RESULTS: SES implantation was successful in all patients, without complication during the first hospital stay. The mean follow-up was 15 (10-24) months. A cardiac event related to the target vessel occurred in 24 (24%) patients, and was associated with dialysis status (p < 0.05), lower ejection fraction (p < 0.05) and revascularization without SES in another site (p < 0.0001). A cardiac event related to the SES occurred in 11 (11%) patients, secondary to an acute or sub-acute thrombosis of the SES (2%), to a late occlusion of the target vessel (4%) or to a non-occlusive restenosis of the SES (5%), and was associated with unstable angina (p < 0.01), multivessel disease (p < 0.03) and revascularization without SES in another site (p < 0.03). No cardiac event related to the SES occurred in patients with direct stenting. Target lesion revascularization for in-SES restenosis or occlusion of the target vessel was performed in 7 (7%) patients, and was associated with unstable angina (p < 0.01) and revascularization without SES in another site (p < 0.01). Target vessel revascularization was needed in 20 patients (20%), related to dialysis status (p < 0.01) and a revascularization without SES in another site (p < .0001). CONCLUSIONS: SESs are effective in the treatment of high risk patients with complex in-stent restenosis. Most of cardiac events during follow-up are related to a revascularization without SES in another site.

Acute and six-month clinical outcome after Helistent stent implantation in coronary arteries: results of the French Helistent multicenter registry.

The purpose of our study was to determine the feasibility, safety, and efficacy of the new tubular (Helistent) stent (Hexacath, France) in patients with coronary artery disease. Patients were prospectively included in a multicenter French registry: acute results and 6-month target lesion revascularization rate were assessed. A total of 628 stents were implanted in 527 patients (616 lesions). Mean age was 64 +/- 11 years. Predilatation was performed in 77% of cases. The stent was successfully deployed in 99.4% of attempted lesions. Three patients died during the hospital stay and 10 patients developed myocardial infarction. Angiographic stent thrombosis rate was 1.1%. There was no need for urgent cardiac surgery during hospital stay. Six-month clinical follow-up was obtained in 95% of patients; target lesion revascularization rate was 8.3%. Eight patients (1.6%) (extracardiac death in three patients) died and three patients (0.6%) developed myocardial infarction. In conclusion, the Helistent stent appears safe and effective in minimizing acute complications of elective coronary interventions. Six-month major cardiac events were rare and clinical restenosis was low (< 10%).