Prevention of Atrial Fibrillation After Atrial Flutter Ablation With Ramipril (from the PREFACE Study).

The clinical efficacy of the inhibitors of the renin-angiotensin-aldosterone system (RAAS) as an upstream therapy for atrial fibrillation (AF) prevention is controversial. No study has itemized so far the role of RAAS inhibitors in AF prevention after atrial flutter (AFL) ablation. This trial aims to investigate the effect of ramipril compared with placebo on AF occurrence in patients hospitalized for AFL ablation without structural heart disease. The Prevention of Atrial Fibrillation by Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter (PREFACE) trial was a prospective, multicenter, randomized, double-blind, double-dummy trial depicting the AF occurrence during a 12-month follow-up as the primary end point. A total of 198 patients hospitalized for AFL ablation were enrolled in the trial and randomized to placebo or ramipril 5 mg/day. Patients were followed up during 1 year after AFL ablation using 1-week Holter electrocardiogram at 3, 6, 9, and 12 months. The intention-to-treat population encompassed 97 patients in the ramipril group and 101 patients in the placebo group. The primary end point, such as AF occurrence during the 1-year follow-up, was not different between the 2 groups (p = 0.96). Secondary end points, including the occurrence of supraventricular arrhythmia (p = 0.50), heart failure, stroke, and death, were not different between the 2 groups. Safety outcome parameters, including serious adverse events leading to treatment disruption (p = 0.10), hypotension, impairment of renal function, and elevated serum potassium level, also were not different between the 2 groups. In conclusion, RAAS inhibition using ramipril does not reduce AF occurrence in patients facing AFL ablation during the 1-year follow-up.

Comparison of clockwise and counterclockwise right atrial flutter using high-resolution mapping and automated velocity measurements.

BACKGROUND: Only few studies have been performed that explore the electrophysiological differences between clockwise (CW) and counterclockwise (CCW) right atrial (RA) cavotricuspid isthmus (CTI)-dependent atrial flutter (AFL) using the high-resolution Rhythmia mapping system. OBJECTIVES: We sought to compare CW and CCW CTI-dependent AFL in pure right AFL patients (pts) using the ultra-high-definition (ultra-HD) Rhythmia mapping system and we mathematically developed a cartography model based on automatic velocity RA measurements to identify electrophysiological AFL specificities. METHODS AND RESULTS: Thirty-three pts were recruited. The mean age was 71 ± 13 years old. The sinus venosus (SV) block line was present in 32/33 of cases (97%) and no significant difference was found between CCW and CW CTI AFL (100% vs. 91%; p = .7). No line was localized in the region of the crista terminalis (CT). A superior gap was present in the posterior line in 14/31 (45.2%) but this was similarly present in CCW AFL, when compared to CW AFL (10/22 [45.5%] vs. 4/10 [40%]; p = .9). When present, the extension of the posterior line of block was observed in 18/31 pts (58%) without significant differences between CCW and CW CI AFL (12/22 [54.5%] vs. 6/10 [60%]; p = .9) The Eustachian ridge line of block was similarly present in both groups (82% [18/22] vs. 45.5% [5/11]; p = .2). The absence of the Eustachian ridge line of block led to significantly slowed velocity in this area (28 ± 10 cm/s; n = 8), and the velocities were similarly altered between both groups (26 ± 10 [4/22] vs. 29.8 ± 11 cm/s [4/11]; p = .6). We created mathematical, three-dimensional RA reconstruction-velocity model measurements. In each block localization, when the block line was absent, velocity was significantly slowed (≤20 cm/s). A systematic slowdown in conduction velocity was observed at the entrance and exit of the CTI in 100% of cases. This alteration to the conduction entrance was localized at the lateral side of the CTI for the CCW AFL and at the septal side of the CTI for CW AFL. The exit-conduction alteration was localized at the CTI septal side for the CCW AFL and at the CTI lateral side for the CW AFL. CONCLUSION: The ultra-HD Rhythmia mapping system confirmed the absence of significant electrophysiological differences between CCW and CW AFL. The mechanistic posterior SV and Eustachian ridge block lines were confirmed in each arrhythmia. A systematic slowing down at the entrance and exit of the CTI was demonstrated in both CCW and CW AFL, but in reverse positions.

ST-segment elevation myocardial infarction: Management and association with prognosis during the COVID-19 pandemic in France.

BACKGROUND: Systems of care have been challenged to control progression of the COVID-19 pandemic. Whether this has been associated with delayed reperfusion and worse outcomes in French patients with ST-segment elevation myocardial infarction (STEMI) is unknown. AIM: To compare the rate of STEMI admissions, treatment delays, and outcomes between the first peak of the COVID-19 pandemic in France and the equivalent period in 2019. METHODS: In this nationwide French survey, data from consecutive STEMI patients from 65 centres referred for urgent revascularization between 1 March and 31 May 2020, and between 1 March and 31 May 2019, were analysed. The primary outcome was a composite of in-hospital death or non-fatal mechanical complications of acute myocardial infarction. RESULTS: A total of 6306 patients were included. During the pandemic peak, a 13.9±6.6% (P=0.003) decrease in STEMI admissions per week was observed. Delays between symptom onset and percutaneous coronary intervention were longer in 2020 versus 2019 (270 [interquartile range 150-705] vs 245 [140-646]min; P=0.013), driven by the increase in time from symptom onset to first medical contact (121 [60-360] vs 150 [62-420]min; P=0.002). During 2020, a greater number of mechanical complications was observed (0.9% vs 1.7%; P=0.029) leading to a significant difference in the primary outcome (112 patients [5.6%] in 2019 vs 129 [7.6%] in 2020; P=0.018). No significant difference was observed in rates of orotracheal intubation, in-hospital cardiac arrest, ventricular arrhythmias and cardiogenic shock. CONCLUSIONS: During the first peak of the COVID-19 pandemic in France, there was a decrease in STEMI admissions, associated with longer ischaemic time, exclusively driven by an increase in patient-related delays and an increase in mechanical complications. These findings suggest the need to encourage the population to seek medical help in case of symptoms.

Predictors of high-degree conduction disturbances and pacemaker implantation after transcatheter aortic valve replacement: Prognostic role of the electrophysiological study.

BACKGROUND: Predictors of high-degree atrioventricular block (HAVB) after transcatheter aortic valve replacement (TAVR) are recognized, but the electrophysiological study's (EPS) role is still a subject to debate. The objective of our study was to determine factors associated with PPM implantation including the potential role of EPS before and/or after TAVR. METHODS AND RESULTS: Seventy four consecutive patients (pts) were included and 21 pts (28.4%) received a PPM during the immediate postoperative follow-ups (until Day 5): HAVB in 15 pts (71.4%), prophylactic implantation due to a documented increased HV interval ≥ 95-100 ms plus LBBB in 2 pts (9.5%), a high-degree HV block evidenced at the EPS plus LBBB in 3 pts (14.3%) and one additional patient was implanted for AV-block in presence of AFib (4.8%). In the multivariate model 1 including parameters before TAVR, both prosthesis diameter and PR lengthening remained significantly associated with PPM as well RBBB. In the multivariate model 2 including parameters after TAVR, only HV remained significantly associated with the risk of PPM (OR = 1.15 (1.05-1.26), p = .004). When all the significant variables in models 1 and 2 were analyzed together in model 3, only HV after TAVR remained significantly associated with an increased risk of PPM. CONCLUSIONS: In this prospective observational study, it was revealed that a Day 4-5 EPS is likely to more precisely stratify the risk of PPM implantation regarding its ability to discover asymptomatic severe infra-hisian conduction disturbances particularly in presence of LBBB. Multivariate analysis confirmed the prognostic value of HV alteration.

Radiation Exposure for Percutaneous Interventions of Chronic Total Coronary Occlusions in a Multicenter Registry: The Influence of Operator Variability and Technical Set-up.

AIMS: Radiation exposure is a limiting factor for percutaneous coronary interventions (PCI) of chronic total coronary occlusion (CTO) lesions. This study was designed to analyze changes in patient radiation dose for CTO-PCI and parameters associated with radiation dose. METHODS AND RESULTS: We analyzed a cohort of 12,136 procedures performed by 23 operators between 2012 and 2017 from the European Registry of CTO-PCI. Radiation exposure was recorded as air kerma (AK) and dose area product (DAP). A dose rate index (DRI) was calculated as AK per fluoroscopy time to normalize for individual differences in fluoroscopy time. The lesion complexity increased from Japanese-CTO (J-CTO) score of 2.19 ± 1.44 to 2.46 ± 1.28, with an increase of retrograde procedures from 31.1% to 40.7%; still, procedural success improved from 87.7% to 92.1%. Fluoroscopy time remained similar, but AK decreased by 14.9%, from 2.35 Gy (interquartile range [IQR], 1.29-4.14 Gy) to 2.00 Gy (IQR, 1.08-3.45 Gy) and DAP decreased by 21.5%, from 130 Gy•cm² (IQR, 70-241 Gy•cm²) to 102 Gy•cm² (IQR, 58-184 Gy•cm²). Radiation exposure was determined by the lesion complexity (J-CTO score) and procedural complexity (antegrade or retrograde). DRI was determined by fluoroscopy frame rate and type of equipment used, but the major influence remained interoperator differences. CONCLUSIONS: Radiation exposure decreased during the observation period despite an increase in lesion and procedural complexity. While many operators already achieved a goal of low radiation exposure, there were considerable interoperator differences in radiation management, indicating further potential for improvement.

Impact of ß-blocker therapy on right ventricular function in heart failure patients with reduced ejection fraction. A prospective evaluation.

BACKGROUND: Beta-blocker (ß-blocker) therapy has been shown to improve mortality and reduce hospitalizations in patients with heart failure (HF) with reduced ejection fraction (HFrEF). Although the physiological action mechanisms of ß-blockers are well described, their effects on right ventricular (RV) function have not been prospectively studied. OBJECTIVE: This prospective study aimed to (a) evaluate whether ß-blocker therapy impacts RV remodeling based on echo parameters and (b) determine the predictive echo factors of ß-blocker therapy response. METHODS: From September 2017 to September 2018, HF patients were prospectively enrolled using CIBIS criteria: Class II, III, or IV HF; left ventricular ejection fraction (LVEF) of ≤40%; hospitalized for HF within the previous 12 months. Echo evaluation was performed before initiating ß-blocker therapy and 3 months after optimal dose adjustment. Based on previous studies, patients with (absolute) LVEF ≥ 5% improvement were considered significant ß-blocker therapy responders. RESULTS: Overall, 40 patients (pts) completed the study, characterized as follows by age: 70 ± 10 years; gender: 10 women; cardiomyopathy etiology: idiopathic in 24 and ischemic in 16; NYHA Class: II in 22 and III in 10; LVEF: 32 ± 5%; and NTProBNP: 2665 ± 2400 pg/mL. The final population comprised 32 pts (79%), with eight (21%) excluded: two because of ß-blocker therapy intolerance, one lost to follow-up, and five withdrew from the study. Under ß-blocker therapy, several echo parameters significantly improved: LVEF from 31.7 ± 9 to 40.5 ± 9 (P < .0001); LV end-diastolic volume (EDV) from 154 ± 54 to 143 ± 45 mL (P = .06); LV end-systolic volume (ESV) from 107 ± 49 to 88 ± 37 mL (P = .0006); LV ES from 46 ± 11 to 64 ± 13 mL (P = .008); LV end-diastolic diameter (EDD) from 57 ± 9 to 54 ± 6 mm (P = .04); LV end-systolic diameter (ESD) from 48 ± 10 to 44 ± 7 mm (P = .007); and right ventricular systolic pressure (RV SP) from 39 ± 10 to 32 ± 8 mm Hg (P = .0001). Significant modifications were observed in terms of RV echo parameters: right ventricular (RV) size decreased from 30 ± 4 to 27 ± 5 mm (P = .03), while RV systolic function significantly improved based on tricuspid annular plane systolic excursion (TAPSE) (16.5 ± 4 vs. 19 ± 4 mm; 0.0006); DTI-derived tricuspid lateral annular systolic velocity wave (S') (10 ± 2 vs. 11.3 ± 3 cm/s; P = .03); and RIMP (Tei index) (0.5 ± 0.1 vs 0.46 ± 0.1; P = .04). RV 2D fractional area change (%) did not significantly differ despite a clear improvement tendency (35 ± 6 vs. 37 ± 4%; P = .1). No significant modifications were observed concerning LV diastolic parameters. Overall, ß-blocker echo responders (n = 23/32; 72%) exhibited the same left and right echo parameters. No echo variables predicted the ß-blocker response. CONCLUSIONS: In HFrEF pts, ß-blocker therapy significantly improves LV and RV systolic remodeling. Accordingly, ß-blocker therapy could be applied as soon as possible in HFrEF patients with right ventricular dysfunction so as to limit RV remodeling.

Management of Left Ventricular Thrombi with Direct Oral Anticoagulants: Retrospective Comparative Study with Vitamin K Antagonists.

BACKGROUND AND OBJECTIVES: The efficacy of direct oral anticoagulants (DOACs) in the management of left ventricular (LV) thrombi remains to be determined, especially in patients with ischemic cardiomyopathy. This retrospective study sought to compare the efficacy of vitamin K antagonists (VKAs) and DOACs in patients with LV thrombi and evaluate the rate of LV thrombus resolution after adjusting anticoagulation. METHODS: This observational retrospective study included patients admitted to our institution for LV thrombus between January 2010 and August 2019. The rate of LV thrombus resolution was compared between VKAs and DOACs. Patients without thrombus resolution with DOAC treatment were switched to VKA agents in order to obtain an international normalized ratio (INR) of 3-4. RESULTS: Between January 2010 and August 2019, 59 consecutive patients with LV thrombi detected by transthoracic echocardiography were included in the study. The mean age was 62 ± 14 years and 16.9% were women. The circumstances of LV thrombus discovery were as follows: acute myocardial infarction or ischemic myocardiopathy (n = 22), stroke (n = 6), chest pain (n = 7), heart failure (n = 11), transthoracic echocardiographic evaluation (n = 11), and ventricular arrhythmias (n = 2). The proportion of patients on DOACs was 28.8% (n = 17), while that of those on VKAs was 71.2% (n = 42). Thrombus resolution was obtained in 70.6% (12/17) of patients on DOACs and in 71.4% (30/42) of those on VKAs (p = 0.9). Patients who failed to respond to DOAC treatment were treated with VKAs, and following this treatment adjustment all LV thrombi were dissolved in the DOAC group (5/5). Five embolic events (8.4% of stroke) occurred before the treatment initiation and six with anticoagulants (2/17 with DOACs [11.8%] and 4/42 with VKAs [9.5%]; p = 0.8). CONCLUSIONS: This retrospective observational study found a similar efficacy between DOAC and VKA agents in patients with LV thrombi (70.6% vs. 71.5%); however, when the thrombus remains, VKAs are still the standard of care as it is possible to control INR levels (3-4) with them.

MRI of Reperfused Acute Myocardial Infarction Edema: ADC Quantification versus T1 and T2 Mapping.

Background After acute myocardial infarction (AMI), reperfusion injury is associated with microvascular lesions and myocardial edema. Purpose To evaluate the performance of apparent diffusion coefficient (ADC) quantification compared with T1 and T2 values in the detection of acute myocardial injury. Materials and Methods In this prospective study conducted from June 2016 to November 2018, participants without a history of heart failure or cardiomyopathy were enrolled after undergoing reperfusion for their first AMI. Quantitative T1 and T2 mapping were performed with a 1.5-T MRI scanner and compared with a fast free-breathing acquisition technique for ADC mapping (approximate duration, 3 minutes; five slices; spin-echo cardiac diffusion acquisition; b values, 0 and 200 sec/mm2; six diffusion-encoding directions; five repetitions). Quantitative ADC and unenhanced T1 and T2 values were compared in infarct, border, and remote regions by using Welch analysis of variance with Games-Howell post hoc test for pairwise comparisons. Results Thirty-four participants with AMI underwent MRI an average of 5 days ± 1.9 (standard deviation) after reperfusion. Mean ADC was markedly high in the infarcted regions (2.32 × 10-3 mm2/sec; 95% confidence interval [CI]: 2.28, 2.36) and moderately high in the border regions (1.91 ×10-3 mm2/sec; 95% CI: 1.89, 1.94; P < .001). In remote regions, mean ADC (1.62 ×10-3 mm2/sec; 95% CI: 1.59, 1.64) was comparable to that measured in vivo in healthy volunteers. Within the same regions of interest, although the measures showed similar trends in infarct and remote regions for T1 (mean, 1332 mec [95% CI: 1296, 1368] vs 1045 msec [95% CI: 1034, 1056]; P < .001) and T2 (72 msec [95% CI: 69, 75] vs 50 msec [95% CI: 49, 51]; P < .001), the magnitude of the differences among regions was greater when using ADC. Normalized signal differences between infarct and remote regions showed that diffusion-weighted MRI depicted edema 5.1 (P < .001) and 3.5 (P < .001) times greater than did T1 and T2 maps, respectively. Conclusion Multislice cardiac diffusion-weighted images could be acquired in those with acute myocardial injury. Quantitative apparent diffusion coefficient mapping showed greater differences among remote regions and lesions than did T1 or T2 mapping. © RSNA, 2020 See also the editorial by Lloyd and Farris in this issue.

Impact of sacubitril/valsartan on echo parameters in heart failure patients with reduced ejection fraction a prospective evaluation.

BACKGROUND: Sacubitril/valsartan has been shown to improve mortality and reduce hospitalizations in patients with heart failure (HF) with reduced ejection fraction (HFrEF). Although the physiological action mechanisms of sacubitril/valsartan are well described, its effects on left ventricular (LV) remodelling and other echocardiographic (echo) parameters have not been prospectively studied. OBJECTIVE: The aim of this prospective study was to: McMurray et al. (2012) [1] evaluate if sacubitril/valsartan impacts LV remodelling based on echo parameters; Ponikowski et al. (2016) [2] identify the predictive factors of sacubitril/valsartan response or intolerance. METHODS: From May 2017 to September 2018, 52 HF patients were prospectively enrolled using PARADIGM-HF criteria: Class II, III, or IV HF; ejection fraction (EF) of 40% or less; hospitalized for HF within the previous 12 months. Echo evaluation was performed before initiating sacubitril/valsartan and 3 months after optimal dose adjustment. Based on previous studies, patients with (absolute) improvement in left ventricular ejection fraction (LVEF) ≥ 5% were considered significant sacubitril/valsartan responders. RESULTS: The 52 patients completing the study were characterized by age: 70 ±â€¯10 years; gender: 11women; aetiology: idiopathic in 20 and ischaemic in 32; NYHA Class: II in 17 and III in 35; LVEF: 32 ±â€¯5%; NTProBNP: 1805 ±â€¯1914 pg/mL. The final population comprised 41 pts (79%), as 11 (21%) did not tolerate sacubitril/valsartan therapy. Under sacubitril/valsartan, several echo parameters significantly improved: LVEF from 32.6 ±â€¯5 to 36 ±â€¯6% (p < 0.0001); LVES volume from 117 ±â€¯40 to 108 ±â€¯46 mL (p = 0.0051); SEV from 59 ±â€¯12 to 64 ±â€¯13 (p = 0.0061); LVEDD from 60 ±â€¯4 to 57 ±â€¯5 mm (p = 0.0002); mean right ventricular systolic pressure (RVSP) from 39 ±â€¯10 to 32 ±â€¯8 (p = 0.0001). No significant modifications were observed concerning LV diastolic parameters or RV echo parameters. Sacubitril/valsartan echo responders (n = 18/41; 42%) had less severe LV remodelling, as shown by LVEDV: 144 ±â€¯37 vs. 193 ±â€¯47 mL, p = 0.0009; LVESV: 96 ±â€¯28 vs. 133 ±â€¯42 mL; p = 0.003; LVTDD: 61 ±â€¯4 vs. 57 ±â€¯5 mm; p = 0.02; significant mitral regurgitation: 6/18 (33%) vs. 16/23 (69%), p = 0.02; no diastolic LV or RV parameters impacted sacubitril/valsartan response. Predictors of sacubitril/valsartan intolerance were baseline creatinine level: 137 ±â€¯99 vs. 100 ±â€¯24, p = 0.03; LVEF: 29 ±â€¯6 vs. 33 ±â€¯5%; p = 0.04. CONCLUSIONS: In HFrEF patients, sacubitril/valsartan significantly improves LV systolic remodelling, without any significant effects on LV diastolic or RV systolic echo parameters. Sacubitril/valsartan responders exhibit both less severe LV remodelling and less significant mitral regurgitation. Accordingly, sacubitril/valsartan could be used as soon as possible in HFrEF patients in order to limit LV remodelling, while precluding non-response or intolerance.

Pre-participation cardiovascular evaluation in Pacific Island athletes.

BACKGROUND: Pre-participation cardiovascular evaluation (PPE) aims to detect cardiac disease with sudden cardiac death (SCD) risk. No study has focused on Pacific Island athletes. METHODS: A total of 2281 Pacific Island athletes were studied with (i) a questionnaire on family, personal history and symptoms, (ii) a physical examination and (iii) a 12-lead ECG. RESULTS: 85% presented a normal history and examination. A positive family history was 1.4-1.9 fold higher in Melanesians, Polynesians and Métis than in Caucasians, while a positive personal history, abnormal symptoms and abnormal examination was 1.3 fold higher in Melanesians and Métis than in others. Neither gender nor training level had a bearing on these results. Melanesians had higher T wave inversions (TWIs) in V2-V4 leads but had no CV abnormalities. Lateral or infero-lateral TWIs were found in 6 male and in 5 highly trained athletes and cardiomyopathies were diagnosed in 3/6 athletes. Overall, 3.9% athletes were found to have a CV abnormality and 0.8% had a risk of SCD. Polynesians and males were more at risk than the others while the level of training made no difference. In athletes at risk of SCD, the main detected CV diseases were cardiomyopathies, Wolff-Parkinson-White (WPW) and severe valve lesions of rheumatoid origin. CONCLUSIONS: PPE revealed that 3.9% presented CV abnormalities. A risk of SCD was found in 0.8% with cardiomyopathies, WPW, and severe valve lesions of rheumatoid origin. Melanesians, Polynesians and male of high level of training were more at risk than others.

Comparison of prevalence and management of left atrial appendage thrombi under old and new anticoagulants prior to left atrial catheter ablation.

BACKGROUND: The prevalence and management of left atrial appendage (LAA) thrombi associated with new anticoagulants remain to be elucidated, especially prior to atrial fibrillation (AFib) ablation. This study sought to (1) compare the prevalence of LAA thrombi and/or severe LAA contrast under vitamin K antagonist (VKA) agents and novel oral anticoagulants (NOACs), (2) evaluate the rate of LAA thrombus resolution after anticoagulation modification, and (3) determine the predictive factors of LAA thrombi and severe LAA contrast in patients prior to LA AFib ablation. METHODS: Between January 2013 and March 2016, 576 consecutive patients referred for AFib ablation were included, and the prevalence of transesophageal echocardiography-detected thrombi was similar under NOACs (2.1%) and VKA agents (2.6%). RESULTS: Thrombus resolution was obtained in 50% of cases following anticoagulation modification. Through multivariate exact logistic regression analysis with relevant clinical and echocardiographic features, age (P<.001), LAA hypocontractility (P<.001), and left ventricular ejection fraction (P=.007) were found to be independently associated with the occurrence of LAA thrombus. The relevant factors independently associated with LAA thrombus or severe contrast were LAA hypocontractility (P<.001) and age (P<.001). CONCLUSIONS: The prevalence of transesophageal echocardiography-detected thrombi in patients referred for AFib ablation is similar under NOACs (2.1%) and VKA agents (2.6%). Under VKA therapy with 3-4 international normalized ratio, 50% of thrombi dissolved. Independent predictive factors of procedure contraindication included age, LAA hypocontractility, and left ventricular ejection fraction.

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 very high pressure stent deployment on angiographic and long-term clinical outcomes in true coronary bifurcation lesions treated by the mini-crush stent technique: A single center experience.

BACKGROUND: Percutaneous coronary intervention (PCI) for bifurcation lesions (BL) using 2 stents technique is known to be associated with high rates of procedural failure especially on the side branch (SB) mainly due to stent incomplete apposition. Stent deployment at very high pressure (SDHP) may lead to better stent expansion and apposition. However, SDHP may also be at the origin of deeper wall injury resulting into major cardiac adverse events. No data are available on evaluation of SDHP in BL treated by a mini-crush stent technique. METHODS: One hundred and thirteen consecutive patients underwent PCI for BL (Medina 1, 1, 1) using a mini-crush stent technique with SDHP defined as ≥20atm. An angiographic follow-up was performed at 6 month and clinical follow-up was obtained at a median of 3 years. RESULTS: Stent deployment mean pressures were 20±1.4atm (range 20-25) in the main vessel (MV) and 20±1.5atm (range 20-25) in SB. Simultaneous final kissing balloon was used in 92% of cases. PCI was successful in 100%. Angiographic follow-up was obtained in 83% of patients. Restenosis rate was 13% (12% restenosis in the SB) with only one case (0.8%) of SB probable thrombosis. Another case of late stent thrombosis occurred at a 3 years clinical follow-up. CONCLUSION: Compared with previously published studies in which stents were deployed at lower pressure, SDHP does not increase the restenosis rate in BL using mini-crush stent technique but seems to reduce the rate of stent thrombosis.

Substantial superiority of Niobe ES over Niobe II system in remote-controlled magnetic pulmonary vein isolation.

BACKGROUND: Catheter ablation of atrial fibrillation (AFib) primarily relies upon pulmonary vein isolation (PVI), but such procedures are associated with significant X-ray exposure. The newer Epoch system has been developed so as to enable more precise magnetic navigation whilst limiting X-ray exposure. OBJECTIVES: This study was aimed at quantifying both exposure time and X-ray reduction with the newer Epoch system compared to Niobe II during AFib ablation procedures. METHODS: From November 2011 to November 2013, our last 92 consecutive patients treated with the Niobe ES (Epoch Solution; 4th generation magnetic navigation technology) system were compared with the first 92 consecutive patients treated using the Niobe II system (3rd generation magnetic navigation technology) for symptomatic drug-refractory AFib. RESULTS: Mean patient age was 59±11years (20% female), and the study population was affected by either symptomatic paroxysmal (65.2%) or persistent (34.8%) AFib. Median procedure time was 2±0.5h and median total X-ray exposure 12.3±6.4min. Procedure time (1.9±0.4 vs. 2.7±1h, p<0.0001) and X-ray duration (12±4 vs. 15±7min, p=0.001) were significantly lower with Niobe ES than with the Niobe II system. X-ray ablation exposure time was also significantly lower with the Niobe ES system than with the Niobe II system (2.9±2 vs. 4±3.5min; p=0.01). Through multivariate analysis, the only predictive factors influencing both procedure duration and X-ray exposure were found to be the Niobe ES system use and LA size. CONCLUSIONS: Our study was the first to demonstrate that the new Niobe ES magnetic robotic system substantially reduced overall operating, fluoroscopy, and ablation times during AFib ablation procedure.

Transcatheter leadless cardiac pacing: The new alternative solution.

INTRODUCTION: A lack of information about the feasibility and safety of leadless pacemaker (LPMs) exists in a fragile population of patients with limited venous anatomy access or conventional pacemaker (PM) contraindication. Accordingly, the goal of this prospective observational study was to report our experience with this new leadless technology in a subset of patients with contraindication or limited venous access. METHODS AND RESULTS: Between May 2015 and July 2016, 14 patients were consecutively included. The indications for initial PM implantation were atrioventricular (AV) block in 10/14 patients (71%), bradyarrhythmia in one (7%), and uncontrolled atrial fibrillation (AFib) requiring AV-node ablation in three (21.5%). AFib was observed in 9 of the 14 patients (64.3%) and 3 were completely dependent with no escape rhythm (21.5%). Normal access pathways via the right or left subclavian veins were occluded due to previous PM implantations and revisions in 4 patients (28.6%) and total vena cava occlusion in 3 (21.4%). End-stage renal disease with hemodialysis was present in 8 (57%) with either local-device infections or presence of long-term implanted dialysis catheters. Evidence of previous bilaterally-infected pectoral tissue was present in 3 patients (21.5%). All procedures were successful (100%) and electrical parameters remained stable over time. No direct pacemaker-related adverse events were reported, including mechanical complications, except for one ventricular fibrillation one day post-implantation under very specific conditions. CONCLUSION: This series demonstrated very stable performance and reassuring safety results during mid-term follow-up in a very fragile population requiring a PM. The Micra LPM constitutes an excellent alternative to the epicardial surgical approach in this very fragile population.

Robotic magnetic navigation for ablation of human arrhythmias.

Radiofrequency treatment represents the first choice of treatment for arrhythmias, in particular complex arrhythmias and especially atrial fibrillation, due to the greater benefit/risk ratio compared to antiarrhythmic drugs. However, complex arrhythmias such as atrial fibrillation require long procedures with additional risks such as X-ray exposure or serious complications such as tamponade. Given this context, the treatment of arrhythmias using robotic magnetic navigation entails a technique well suited to complex arrhythmias on account of its efficacy, reliability, significant reduction in X-ray exposure for both patient and operator, as well as a very low risk of perforation. As ongoing developments will likely improve results and procedure times, this technology will become one of the most modern technologies for treating arrhythmias. Based on the literature, this review summarizes the advantages and limitations of robotic magnetic navigation for ablation of human arrhythmias.

Restenosis after percutaneous coronary intervention for coronary chronic total occlusion. The central role of an optimized immediate post-procedural angiographic result.

BACKGROUND: Factors of restenosis after percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO) have not been fully explored. In particular, although the last ACC/AHA guidelines on PCI suggest that a minimum diameter stenosis of 10% with an optimal goal of as close to 0% as possible should be the new benchmark for lesions treated by stenting, angiographic success of PCI for CTO remains in the literature most often defined as a <30% residual diameter stenosis. Whether an optimized immediate post-PCI angiographic result (OAR) defined by a minimal diameter stenosis as close to 0% is associated with a lower restenosis rate in this subset of coronary lesions remains unknown. METHODS: Therefore, we assessed by quantitative coronary analysis (QCA) both the immediate post-PCI and 6-month follow-up angiographic results of 170 successfully treated true CTO. RESULTS: Post-PCI QCA immediate residual diameter stenosis was <30% in all 170 CTOs and OAR defined as a ≤10% residual stenosis was achieved in 133 (78%). Global binary restenosis rate was 21% in the 170 lesions. Restenosis rates were 46% and 14% in the non-OAR group and in the OAR group, respectively (p<0.0001). Multivariate analysis showed that a non-OAR, a younger age and a retrograde approach were independent factors of restenosis. CONCLUSION: Thus, an optimized immediate angiographic result with a minimal diameter stenosis as close to 0% as possible appears to be associated with a lower rate of restenosis after CTO PCI.

Unusual complication during a percutaneous coronary intervention for a bifurcation lesion using T and Protrusion technique.

Our case reports the first migration of a stent already deployed at high pressure in the main vessel during a 2-stent strategy for a bifurcation lesion using T and protrusion technique. The Kissing balloon was not optimal and could have led to an insufficient strut/cell opening and then to LAD stent pulled back into the artery tree. This case report highlights the importance of an optimal Kissing Balloon in two stent bifurcation technique.