Clinical effects of permanent pacemaker implantation after transcatheter aortic valve implantation: Insights from the nationwide FRANCE-TAVI registry.

BACKGROUND: The influence of permanent pacemaker implantation upon outcomes after transcatheter aortic valve implantation (TAVI) remains controversial. AIMS: To evaluate the impact of permanent pacemaker implantation after TAVI on short- and long-term mortality, and on the risk of hospitalization for heart failure. METHODS: Data from the large FRANCE-TAVI registry, linked to the French national health single-payer claims database, were analysed to compare 30-day and long-term mortality rates and hospitalization for heart failure rates among patients with versus without permanent pacemaker implantation after TAVI. Multivariable regressions were performed to adjust for confounders. RESULTS: A total of 36,549 patients (mean age 82.6years; 51.6% female) who underwent TAVI from 2013 to 2019 were included in the present analysis. Among them, 6999 (19.1%) received permanent pacemaker implantation during the index hospitalization, whereas 232 (0.6%) underwent permanent pacemaker implantation between hospital discharge and 30days after TAVI, at a median of 11 (interquartile range: 7-18) days. In-hospital permanent pacemaker implantation was not associated with an increased risk of death between discharge and 30days (adjusted odds ratio: 0.91, 95% confidence interval: 0.64-1.29). At 5years, the incidence of all-cause death was higher among patients with versus without permanent pacemaker implantation within 30days of the procedure (adjusted hazard ratio: 1.13, 95% confidence interval: 1.07-1.19). Permanent pacemaker implantation within 30days of TAVI was also associated with a higher 5-year rate of hospitalization for heart failure (adjusted subhazard ratio: 1.17, 95% confidence interval: 1.11-1.23). CONCLUSIONS: Permanent pacemaker implantation after TAVI is associated with an increased risk of long-term hospitalization for heart failure and all-cause mortality. Further research to mitigate the risk of postprocedural permanent pacemaker implantation is needed as TAVI indications expand to lower-risk patients.

Echocardiographic estimation of pulmonary pressure in patients with severe tricuspid regurgitation.

OBJECTIVES: The estimation of systolic pulmonary artery pressure (sPAP) by transthoracic echocardiography (TTE) is challenging in patients with severe tricuspid regurgitation (TR). The study aimed to determine the reliability of the assessment of sPAP by TTE in this population. METHODS: This study was a single-centre analysis of consecutive patients at the University Hospital of Rennes with right heart catheterisation and TTE, performed with a maximum delay of 48 hours. Lin's concordance coefficient (LCC) and Bland-Altman analysis were used to compare the values. RESULTS: After applying the exclusion criteria, 236 patients were included in the analysis (age 71±11.5 years old; male 56%). The two principal indications were TR (34.3%) and mitral regurgitation (32.2%). The correlation between the two procedures was good in the total population (LCC=0.80; 95% limits of agreement (LOA): 0.74, 0.84), but weaker in the 78 patients (33%) with severe TR (LCC=0.67; 95% LOA: 0.49, 0.80), with a propensity to an underestimation by TTE. An elevated right atrial pressure (RAP) was associated with an underestimation by TTE of about 8 mmHg. The presence of a 'V-wave cut-off' sign on continuous-wave Doppler (OR=3.74; 95% CI 1.48, 9.30; p<0.01), found exclusively in patients with severe TR, was an independent predictor of sPAP misestimation by TTE. CONCLUSION: The reliability of the estimation of sPAP in patients with severe TR could be altered by high RAP which cannot be estimated with current thresholds.

Conductive disturbances in the transcatheter aortic valve implantation setting: An appraisal of current knowledge and unmet needs.

New-onset conduction disturbances, including left bundle branch block and permanent pacemaker implantation, remain a major issue after transcatheter aortic valve implantation. Preprocedural risk assessment in current practice is most often limited to evaluation of the baseline electrocardiogram, whereas it may benefit from a multimodal approach, including ambulatory electrocardiogram monitoring and multidetector computed tomography. Physicians may encounter equivocal situations during the hospital phase, and the management of follow-up is not fully defined, despite the publication of several expert consensuses and the inclusion of recommendations regarding the role of electrophysiology studies and postprocedural monitoring in recent guidelines. This review provides an overview of current knowledge and future perspectives regarding the management of new-onset conduction disturbances in the setting of transcatheter aortic valve implantation, from the preprocedural phase to long-term follow-up.

Evolution of non-invasive myocardial work variables after transcatheter aortic valve implantation in patients with severe aortic stenosis.

INTRODUCTION: Guidelines recommend aortic valve replacement in patients with severe aortic stenosis who present with symptoms or left ventricular ejection fraction<50%, both conditions representing a late stage of the disease. Whereas global longitudinal strain is load dependent, but interesting for assessing prognosis, myocardial work has emerged. AIM: To evaluate acute changes in myocardial work occurring in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: Patients who underwent TAVI were evaluated before and after by echocardiography. Complete echocardiographies were considered. Myocardial work indices (global work index, global constructive work, global work efficiency, global wasted work) were calculated integrating mean transaortic pressure gradient and brachial cuff systolic pressure. RESULTS: One hundred and twenty-five patients underwent successful TAVI, with a significant decrease in mean transaortic gradient (from 52.5±16.1 to 12.2±5.0; P<0.0001). There was no significant change in left ventricular ejection fraction after TAVI. Myocardial work data after TAVI showed a significant reduction in global work index (1389±537 vs. 2014±714; P<0.0001), global constructive work (1693±543 vs. 2379±761; P<0.0001) and global work efficiency (85.0±7.06 vs. 87.1±5.98; P=0.0034). The decrease in global work index and global constructive work after TAVI was homogeneous among different subgroups, based on global longitudinal strain, left ventricular ejection fraction and New York Heart Association status before TAVI. We observed a significant association between global work index and global constructive work before TAVI, and global longitudinal strain degradation after TAVI. CONCLUSIONS: Myocardial work variables show promising potential in best understanding the left ventricular myocardial consequences of aortic stenosis and its correction. Given their ability to discriminate between New York Heart Association status and global longitudinal strain evolution, we can hypothesize about their clinical value.

Prognostic impact of permanent pacemaker implantation after transcatheter aortic valve replacement.

BACKGROUND: Conduction disturbances requiring permanent pacemaker implantation (PPI) remain a common complication of transcatheter aortic valve replacement (TAVR). OBJECTIVE: The purpose of this study was to determine the prognostic impact of PPI after TAVR according to the timing of implantation relative to TAVR. METHODS: A total of 1199 patients (median age 83 years; interquartile range 78-86 years; 549 [45.8%] female) were included in the analysis, of whom 894 (70.8%) had not undergone PPI, 130 (10.8%) had undergone previous PPI, 116 (9.7%) had undergone in-hospital PPI, and 59 (4.9%) had undergone PPI during follow-up. Median follow-up was 2.94 years (1.42-4.32 years). The primary outcome was the composite of all-cause mortality and hospitalization for heart failure. RESULTS: PPI during follow-up was associated with a higher occurrence of the primary outcome (hazard ratio [HR] 2.11; 95% confidence interval [CI] 1.39-3.20) whereas previous PPI and in-hospital PPI were not (HR 0.96; 95% CI 0.71-1.29 and HR 1.26; 95% CI 0.88-1.81, respectively). PPI during follow-up was associated with a higher risk of hospitalization for heart failure (sub-HR 3.21; 95% CI 2.02-5.11), while this relationship was only borderline significant for previous PPI (sub-HR 1.51; 95% CI 0.99-2.29). In contrast, there was no relationship between in-hospital PPI and the subsequent risk of hospitalization for heart failure. CONCLUSION: Previous PPI and in-hospital PPI had no long-term prognostic impact on the risk of all-cause mortality and hospitalization for heart failure, whereas PPI during follow-up was associated with a higher risk of hospitalization for heart failure. The present study questions the deleterious influence of periprocedural post-TAVR PPI, which has previously been suggested by certain studies.

Validation of a Whole Heart Segmentation from Computed Tomography Imaging Using a Deep-Learning Approach.

The aim of this study is to develop an automated deep-learning-based whole heart segmentation of ECG-gated computed tomography data. After 21 exclusions, CT acquired before transcatheter aortic valve implantation in 71 patients were reviewed and randomly split in a training (n = 55 patients), validation (n = 8 patients), and a test set (n = 8 patients). A fully automatic deep-learning method combining two convolutional neural networks performed segmentation of 10 cardiovascular structures, which was compared with the manually segmented reference by the Dice index. Correlations and agreement between myocardial volumes and mass were assessed. The algorithm demonstrated high accuracy (Dice score = 0.920; interquartile range: 0.906-0.925) and a low computing time (13.4 s, range 11.9-14.9). Correlations and agreement of volumes and mass were satisfactory for most structures. Six of ten structures were well segmented. Deep-learning-based method allowed automated WHS from ECG-gated CT data with a high accuracy. Challenges remain to improve right-sided structures segmentation and achieve daily clinical application.

Early and late ventricular arrhythmias complicating ST-segment elevation myocardial infarction.

BACKGROUND: Ventricular arrhythmias can be life-threatening complications of ST-segment elevation myocardial infarction (STEMI). AIMS: To describe the incidence, predictors and in-hospital impact of early ventricular arrhythmia (EVA, occurring

Electrophysiological Study-Guided Permanent Pacemaker Implantation in Patients With Conduction Disturbances Following Transcatheter Aortic Valve Implantation.

Conduction disturbances remain common following transcatheter aortic valve implantation (TAVI). Aside from high-degree atrioventricular block (HAVB), their optimal management remains elusive. Invasive electrophysiological studies (EPS) may help stratify patients at low or high risk of HAVB allowing for an early discharge or permanent pacemaker (PPM) implantation among patients with conduction disturbances. We evaluated the safety and diagnostic performances of an EPS-guided PPM implantation strategy among TAVI recipients with conduction disturbances not representing absolute indications for PPM. All patients who underwent TAVI at a single expert center from June 2017 to July 2020 who underwent an EPS during the index hospitalization were included in the present study. False negative outcomes were defined as patients discharged without PPM implantation who required PPM for HAVB within 6 months of the initial EPS. False positive outcomes were defined as patients discharged with a PPM with a ventricular pacing percentage <1% at follow-up. A total of 78 patients were included (median age 83.5, 39% female), among whom 35 patients (45%) received a PPM following EPS. The sensitivity, specificity, positive and negative predictive values of the EPS-guided PPM implantation strategy were 100%, 89.6%, 81.5%, and 100%, respectively. Six patients suffered a mechanical HAVB during EPS and received a PPM. These 6 patients showed PPM dependency at follow-up. In conclusion, an EPS-guided PPM implantation strategy for managing post-TAVI conduction disturbances appears effective to identify patients who can be safely discharged without PPM implantation.

Effects of Remote Ischemic Pre-Conditioning to Prevent Contrast-Induced Nephropathy after Intravenous Contrast Medium Injection: A Randomized Controlled Trial.

OBJECTIVE: We aimed to assess the effects of remote ischemic pre-conditioning (RIPC) on the incidence of contrast-induced nephropathy (CIN) after an intravenous (IV) or intra-arterial injection of contrast medium (CM) in patient and control groups. MATERIALS AND METHODS: This prospective, randomized, single-blinded, controlled trial included 26 patients who were hospitalized for the evaluation of the feasibility of transcatheter aortic valve implantation and underwent investigations including contrast-enhanced computed tomography (CT), with Mehran risk scores greater than or equal to six. All the patients underwent four cycles of five minute-blood pressure cuff inflation followed by five minutes of total deflation. In the RIPC group (n = 13), the cuff was inflated to 50 mm Hg above the patient's systolic blood pressure (SBP); in the control group (n = 13), it was inflated to 10 mm Hg below the patient's SBP. The primary endpoint was the occurrence of CIN. Additionally, variation in the serum levels of cystatin C was assessed. RESULTS: One case of CIN was observed in the control group, whereas no cases were detected in the RIPC group (p = 0.48, analysis of 25 patients). Mean creatinine values at the baseline, 24 hours after injection of CM, and 48 hours after injection of CM were 88 ± 32 µmol/L, 91 ± 28 µmol/L and 82 ± 29 µmol/L, respectively (p = 0.73) in the RIPC group, whereas in the control group, they were 100 ± 36 µmol/L, 110 ± 36 µmol/L, and 105 ± 34 µmol/L, respectively (p = 0.78). Cystatin C values (median [Q1, Q3]) at the baseline, 24 hours after injection of CM, and 48 hours after injection of CM were 1.10 [1.08, 1.18] mg/L, 1.17 [0.97, 1.35] mg/L, and 1.12 [0.99, 1.24] mg/L, respectively (p = 0.88) in the RIPC group, whereas they were 1.11 [0.97, 1.28] mg/L, 1.13 [1.08, 1.25] mg/L, and 1.16 [1.03, 1.31] mg/L, respectively (p = 0.93), in the control group. CONCLUSION: The risk of CIN after an IV injection of CM is very low in patients with Mehran risk score greater than or equal to six and even in the patients who are unable to receive preventive hyperhydration. Hence, the Mehran risk score may not be an appropriate method for the estimation of the risk of CIN after IV CM injection.

Determinants and Impact of Heart Failure Readmission Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Heart failure (HF) readmission is common post-transcatheter aortic valve replacement (TAVR). Nonetheless, limited data are available regarding its predictors and clinical impact. This study evaluated the incidence, predictors, and impact of HF readmission within 1-year post-TAVR, and assessed the effects of the prescription of HF therapies at discharge on the risk of HF readmission and death. METHODS: Patients included in the TAVR registry of a single expert center from 2009 to 2017 were analyzed. Competing-risk and Cox regressions were performed to identify predictors of HF readmission and death. RESULTS: Among 750 patients, 102 (13.6%) were readmitted for HF within 1-year post-TAVR. Overall, 53 patients (7.1%) experienced late readmissions (>30 days post-TAVR), and 17 (2.3%) had multiple readmissions. In ≈30% of readmissions, no trigger could be identified. Predominant causes of readmissions were changes in medication/nonadherence and supraventricular arrhythmia. Independent predictors of HF readmission included diabetes mellitus, chronic lung disease, previous acute HF, grade III or IV aortic regurgitation, and pulmonary hypertension both at discharge from the index hospitalization but not HF therapies. Overall, HF readmission did not significantly impact all-cause mortality (hazard ratio [HR], 1.36 [95% CI, 0.99-1.85]). However, late (HR, 1.90 [95% CI, 1.30-2.78]) and multiple HF readmissions (HR, 2.10 [95% CI,1.17-3.76]) were significantly associated with all-cause mortality. Prescription of renin-angiotensin system inhibitors at discharge was associated with a lower rate of all-cause mortality, especially among patients receiving doses of 25% to <50% (HR, 0.67 [95% CI, 0.48-0.94]) and 75% to 100% (HR, 0.61 [95% CI, 0.37-0.98]) of the optimal daily dose. CONCLUSIONS: HF readmission is common within 1-year of TAVR. Late and multiple HF readmissions associate with an increased risk of long-term all-cause mortality. Baseline comorbidities (diabetes, chronic lung disease, previous acute HF) and echocardiographic findings at discharge (grade III or IV aortic regurgitation, pulmonary hypertension) identified patients at high risk of HF readmission.

Pharmacoinvasive Strategy Versus Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction in Patients ≥70 Years of Age.

The benefit-risk ratio of a pharmacoinvasive strategy (PI) in patients ≥70 years of age with ST-segment elevation myocardial infarction (STEMI) remains uncertain resulting in its limited use in this population. This study compared efficacy and safety of PI with primary percutaneous coronary intervention (pPCI). Data from 2,841 patients (mean age: 78.1 ± 5.6 years, female: 36.1%) included in a prospective multicenter registry, and who underwent either PI (n = 269) or pPCI (n = 2,572), were analyzed. The primary end point was in-hospital major adverse cardiovascular events (MACE) defined as the composite of all-cause mortality, nonfatal MI, stroke, and definite stent thrombosis. Secondary end points included all-cause death, major bleeding, net adverse clinical events, and the development of in-hospital Killip class III or IV heart failure. Propensity-score matching and conditional logistic regression were used to adjust for confounders. Within the matched cohort, rates of MACE was not statistically different between the PI (n = 247) and pPCI (n = 958) groups, (11.3% vs 9.0%, respectively, odds ratio 1.25, 95% confidence interval 0.81 to 1.94; p = 0.31). Secondary end points were comparable between groups at the exception of a lower rate of development of Killip class III or IV heart failure after PI. The rate of intracranial hemorrhage was significantly higher in the PI group (2.3% vs 0.0%, p = 0.03). In conclusion, the present study demonstrated no difference regarding in-hospital MACE following PI or pPCI in STEMI patients ≥70 years of age. An adequately-powered randomized trial is needed to precisely define the role of PI in this high-risk subgroup.

Management of aortic valve replacement according to the gradient across symptomatic aortic valve stenosis and its prognostic impact.

BACKGROUND: Treatment strategy for low-gradient (LG) aortic stenosis (AS) remains an unresolved issue. The presence of a low aortic gradient and preserved left ventricular ejection fraction (LVEF) might lead toward the underestimation of aortic stenosis severity and a more conservative management. We sought (a) to describe the nature and timing of intervention according to flow/gradient subgroups in patibents with LG-AS, (2) to determine the factors associated with the decision to intervene, and (c) to describe prognosis. METHODS AND RESULTS: One hundred and ten patients prospectively included in this study underwent a standardized clinical and imaging evaluation at inclusion and at 1-year follow-up. According to aortic flow, gradient and LVEF, patients were divided into 4 groups: LG-normal flow [n = 27], LG-low flow-low LVEF [n = 27], LG-low flow-normal LVEF [n = 16], and high gradient (HG) [n = 40]). 73% of patients underwent AVR 86 ± 59 days after the initial assessment. The HG subgroup had significantly higher intervention rates (P < .001). In multivariable analysis, four parameters were associated with the AVR: aortic gradient (HR 1.52 [1.10-2.11], P = .012), LVEF (HR 0.58 [0.40-0.85], P = .006), atrial fibrillation (HR 0.43 [0.021-0.87], P = .019), and NT-proBNP (HR 0.92[0.86-0.98), P = .008]. Patients operated earlier had better outcomes than those having a delayed AVR (P = .042). LG-AS patients had worse outcomes than HG-AS patients (P < .001). CONCLUSION: Compared to HG-AS, LG-AS is less likely to benefit from an AVR and had a significantly worse outcome. Further interventional studies are needed to investigate the timing of AVR in these patients.

Comparison of the Transarterial and Transthoracic Approaches in Nontransfemoral Transcatheter Aortic Valve Implantation.

Transfemoral approach stands as the reference access-route for transcatheter aortic valve implantation (TAVI). Nonetheless, alternatives approaches are still needed in a significant proportion of patients. This study aimed at comparing outcomes between transthoracic-approach (transapical or transaortic) and transarterial-approach (transcarotid or subclavian) TAVI. Data from 191 consecutive patients who underwent surgical-approach TAVI from May 2009 to September 2017 were analyzed. Patients were allocated in 2 groups according to the approach. The primary end point was the 30-day composite of death of any cause, need for open surgery, tamponade, stroke, major or life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary obstruction, or major vascular complications. During the study period, 104 patients underwent transthoracic TAVI (transapical: 60.6%, transaortic: 39.4%) whereas 87 patients underwent transarterial TAVI (subclavian: 83.9%, transcarotid: 16.1%). Logistic EuroSCORE I tended to be higher in transthoracic-TAVI recipients. In-hospital and 30-day composite end point rates were 25.0% and 11.5% (p = 0.025), and 26.0% and 14.9% (p = 0.075) for the transthoracic and transarterial cohorts, respectively. Propensity score-adjusted logistic regression demonstrated no significant detrimental association between the 30-day composite end point and transthoracic access (odds ratio 2.12 95% confidence interval 0.70 to 6.42; p = 0.18). Transarterial TAVI was associated with a shorter length of stay (median: 6 vs 7 days, p <0.001). TAVI approach was not an independent predictor of midterm mortality. In conclusion, nontransfemoral transarterial-approach TAVI is safe, feasible, and associated with comparable rates of major perioperative complications, and midterm mortality compared with transthoracic-approach TAVI.

Current indications for the intra-aortic balloon pump: The CP-GARO registry.

BACKGROUND: Intra-aortic balloon pumps (IABPs) have been used routinely since the 1970s. Recently, large randomized trials failed to show that IABP therapy has meaningful benefit, and international recommendations downgraded its place, particularly in cardiogenic shock. AIMS: The aim of this registry was to describe the contemporary use of IABP therapy, in light of these new data. METHODS: This prospective multicentre registry included 172 patients implanted with an IABP in 19 French cardiac centres in 2015. Baseline characteristics, aetiologies leading to IABP use, and IABP-related and disease-related complications were assessed. In-hospital and 1-year mortality rates were studied. RESULTS: A total of 172 patients were included (mean age 65.5±12.0 years; 118 men [68.6%]). The reasons for IABP implantation were mainly haemodynamic (n=107; 62.2%), followed by bridge to revascularization (n=34; 19.8%) and four other "rare" aetiologies (n=29 patients; 16.8%). In-hospital and 1-year mortality rates were 40.7% and 45.8%, respectively. Fourteen patients (8.1%) experienced ischaemic or haemorrhagic complications, which were directly related to the IABP in seven patients (4.1%). CONCLUSIONS: Despite current international guidelines regarding the place of IABPs in ischaemic cardiogenic shock without mechanical complications, this aetiology remains the leading cause for its utilization in the contemporary era.

Predicting the development of in-hospital cardiogenic shock in patients with ST-segment elevation myocardial infarction treated by primary percutaneous coronary intervention: the ORBI risk score.

Aims: To derive and validate a readily useable risk score to identify patients at high-risk of in-hospital ST-segment elevation myocardial infarction (STEMI)-related cardiogenic shock (CS). Methods and results: In all, 6838 patients without CS on admission and treated by primary percutaneous coronary intervention (pPCI), included in the Observatoire Régional Breton sur l'Infarctus (ORBI), served as a derivation cohort, and 2208 patients included in the obseRvatoire des Infarctus de Côte-d'Or (RICO) constituted the external validation cohort. Stepwise multivariable logistic regression was used to build the score. Eleven variables were independently associated with the development of in-hospital CS: age >70 years, prior stroke/transient ischaemic attack, cardiac arrest upon admission, anterior STEMI, first medical contact-to-pPCI delay >90 min, Killip class, heart rate >90/min, a combination of systolic blood pressure <125 mmHg and pulse pressure <45 mmHg, glycaemia >10 mmol/L, culprit lesion of the left main coronary artery, and post-pPCI thrombolysis in myocardial infarction flow grade <3. The score derived from these variables allowed the classification of patients into four risk categories: low (0-7), low-to-intermediate (8-10), intermediate-to-high (11-12), and high (≥13). Observed in-hospital CS rates were 1.3%, 6.6%, 11.7%, and 31.8%, across the four risk categories, respectively. Validation in the RICO cohort demonstrated in-hospital CS rates of 3.1% (score 0-7), 10.6% (score 8-10), 18.1% (score 11-12), and 34.1% (score ≥13). The score demonstrated high discrimination (c-statistic of 0.84 in the derivation cohort, 0.80 in the validation cohort) and adequate calibration in both cohorts. Conclusion: The ORBI risk score provides a readily useable and efficient tool to identify patients at high-risk of developing CS during hospitalization following STEMI, which may aid in further risk-stratification and thus potentially facilitate pre-emptive clinical decision making.

Immediate complete revascularization in patients with ST-segment elevation myocardial infarction and multivessel disease treated by primary percutaneous coronary intervention: Insights from the ORBI registry.

BACKGROUND: Recent studies demonstrated the superiority of complete revascularization (CR) in patients treated by primary percutaneous coronary intervention (pPCI) in ST-elevation myocardial infarction (STEMI). AIM: To evaluate whether immediate CR improves in-hospital outcomes in patients with STEMI with multivessel disease. METHODS: Data from a prospective multicentre registry including 9365 patients with STEMI were analysed. Patients with multivessel disease and treated with pPCI (n=3412) were included and separated into two groups according to whether immediate CR was performed during the index procedure. The primary endpoint was in-hospital major adverse cardiovascular events (MACE), defined as a composite of all-cause death, non-fatal myocardial infarction, stroke and definite stent thrombosis. Secondary endpoints were individual components of MACE and major bleeding. Multivariable Cox regression and propensity-score adjustment were performed to account for confounders. RESULTS: Immediate CR was performed in 98 patients (2.9%), whereas 3314 patients (97.1%) were incompletely revascularized. The prevalence of severe heart failure (Killip class III or IV) and significant lesions of the left main coronary artery were higher in the immediate CR group (21.6% vs. 13.5% and 24.5% vs. 6.7%, respectively; P<0.001 for both). After adjustment, immediate CR was not associated with reduced rates of MACE (hazard ratio [HR] 0.64, 95% confidence interval [CI]: 0.31-1.35; P=0.24) or all-cause death (HR: 0.52, 95% CI: 0.23-1.16; P=0.11), but with increased risks of definite stent thrombosis (HR: 3.93, 95% CI: 1.12-13.75; P=0.03) and major bleeding (HR: 17.46, 95% CI: 2.29-133.17; P=0.006). CONCLUSION: Immediate CR did not improve in-hospital outcomes of patients with STEMI with multivessel disease in this analysis. Randomized studies are warranted to elucidate the optimal timing of CR in patients with STEMI.

Anomalous Origin of the Left Coronary Artery From the Pulmonary Artery Presenting in Adulthood: a French Nationwide Retrospective Study.

Anomalous origin of the left coronary artery from the pulmonary artery (ALCAPA) is a rare congenital heart disease usually diagnosed during the first months of life. Without surgical treatment, ALCAPA carries a high mortality risk, and disease presentation in adulthood is rare. We describe the diagnosis and management of patients presenting with ALCAPA in adulthood. This multicenter French nationwide retrospective study included adult patients diagnosed from 1980 to 2014. Eleven adult patients (mean age: 38 ± 17 years) were analyzed. All patients were symptomatic, presenting with chest pain, palpitations, heart failure, or syncope. Electrocardiogram was abnormal in 8 (73%) patients. Echocardiogram showed a mildly depressed left ventricular ejection fraction of 50 ± 13%, kinetic abnormalities in 5 (45%) patients, and significant mitral regurgitation in 8 (73%) patients. Coronary angiography was performed in 10 (91%) patients and confirmed the diagnosis. Computerized tomography scan, magnetic resonance imaging, and myocardial scintigraphy were performed when deemed necessary. Ten patients underwent reconstructive surgery, but 1 patient was not operated because of age. Four patients experienced postoperative complications including cardiogenic shock, heart failure, renal failure, or additional surgery. After a median follow-up of 2.5 years, all 10 operated patients were alive and asymptomatic, and the nonoperated patient had died at the age of 70 from syncope related to ventricular tachycardia. ALCAPA may be diagnosed in adults. Although complications may occur postoperatively, long-term outcome is favorable in adult patients undergoing surgical correction. Surgery should be discussed as first-line therapy in adults with ALCAPA.

Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Lower-Surgical-Risk Patients With Chronic Obstructive Pulmonary Disease.

Respiratory complications are a major factor contributing to postoperative morbidity and mortality, especially in patients with chronic obstructive pulmonary disease (COPD). Our objective was to compare the rate of respiratory complications in patients with COPD with severe aortic stenosis who underwent transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR). Low-to-intermediate surgical-risk patients with moderate or severe COPD who underwent TAVI or SAVR at 2 tertiary centers were included in this study. COPD was defined by the Global Initiative for Chronic Lung Disease classification. The primary end point was the 30-day composite of respiratory mortality, prolonged ventilation (>24 hours), the need for reintubation for respiratory causes, tracheostomy, acute respiratory distress syndrome, pneumonia, or pneumothorax. The inverse probability of treatment weighting was determined to reduce baseline imbalance between the 2 groups. A total of 321 patients (mean age 72.4 ± 9.3 years old, 74.5% male, mean Society of Thoracic Surgeons predicted risk of mortality 3.8 ± 1.9%, mean forced expiratory volume 1: 59 ± 13%) were included in the analysis. TAVI was performed in 122 patients, whereas 199 underwent SAVR. There were no differences between the 2 groups regarding the composite respiratory primary end point (SAVR 10.6%, TAVR 7.4%, adjusted odds ratio 0.57, 95% confidence interval 0.20 to 1.65, p = 0.30). Transfemoral TAVI without general anesthesia (28 patients) was associated with the lowest rate of respiratory complications (3.6%). Among patients with moderate or severe COPD at low-to-intermediate surgical risk, TAVI patients had a similar rate of 30-day major pulmonary complications compared with SAVR patients despite a higher baseline risk profile. Future studies should further investigate whether TAVI is associated with reduced respiratory complications, comparing transfemoral TAVI recipients treated with local anesthesia with their SAVR counterparts.

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).

Efficacy and safety of prehospital administration of unfractionated heparin, enoxaparin or bivalirudin in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: Insights from the ORBI registry.

BACKGROUND: Despite numerous studies in recent years, the best anticoagulant option for primary percutaneous coronary intervention (PCI) remains a matter of debate. AIMS: To compare in-hospital outcomes after prehospital administration of low-dose unfractionated heparin (UFH)±glycoprotein IIb/IIIa inhibitors (GPIs), enoxaparin±GPIs, or bivalirudin in patients undergoing primary PCI for ST-segment elevation myocardial infarction (STEMI). METHODS: A total of 1720 patients (median age 62.0 years, 79.2% male) who had been enrolled in a prospective registry and received an injectable anticoagulant in physician-staffed mobile intensive care units before primary PCI were included in the study. The main outcomes were in-hospital major adverse cardiovascular events (MACE) (a composite of all-cause mortality, non-fatal myocardial infarction, stroke or definite stent thrombosis) and in-hospital major bleeding (Bleeding academic research consortium type 3 or 5). RESULTS: UFH was administered in 420 (24.4%) patients, enoxaparin in 1163 (67.6%) patients and bivalirudin in 137 patients (8.0%). Rates of in-hospital MACE were 7.4% with UFH, 6.0% with enoxaparin and 6.6% with bivalirudin, with no significant differences between groups (P=0.628). In-hospital major bleeding occurred in 1.7% of patients on UFH, 1.4% on enoxaparin and 1.5% on bivalirudin (P=0.851). By multivariable analysis, the prehospital anticoagulant used was not an independent predictor of MACE or major bleeding. CONCLUSION: In this prospective registry, there were no significant differences in the rates of in-hospital MACE or major bleeding after prehospital initiation of UFH, enoxaparin or bivalirudin in patients treated by primary PCI for STEMI.