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).

Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB-TAVI Study.

INTRODUCTION: Percutaneous aortic valve replacement (transcatheter aortic valve implantation (TAVI)) notably increases the likelihood of the appearance of a complete left bundle branch block (LBBB) by direct lesion of the LBB of His. This block can lead to high-grade atrioventricular conduction disturbances responsible for a poorer prognosis. The management of this complication remains controversial. METHOD AND ANALYSIS: The screening of LBBB after TAVI persisting for more than 24 hours will be conducted by surface ECG. Stratification will be performed by post-TAVI intracardiac electrophysiological study. Patients at high risk of conduction disturbances (≥70 ms His-ventricle interval (HV) or presence of infra-Hisian block) will be implanted with a pacemaker enabling the recording of disturbance episodes. Those at lower risk (HV <70 ms) will be implanted with a loop recorder device with remote monitoring of cardiovascular implantable electronic devices (CIEDs). Clinical, ECG and implanted device follow-up will also be performed at 3, 6 and 12 months. The primary objective is to assess the efficacy and safety of a decisional algorithm based on electrophysiological study and remote monitoring of CIEDs in the prediction of high-grade conduction disturbances in patients with LBBB after TAVI. The primary end point is to compare the incidence (rate and time to onset) of high-grade conduction disturbances in patients with LBBB after TAVI between the two groups at 12 months. Given the proportion of high-grade conduction disturbances (20-40%), a sample of 200 subjects will allow a margin of error of 6-7%. The LBBB-TAVI Study has been in an active recruiting phase since September 2015 (21 patients already included). ETHICS AND DISSEMINATION: Local ethics committee authorisation was obtained in May 2015. We will publish findings from this study in a peer-reviewed scientific journal and present results at national and international conferences. TRIAL REGISTRATION NUMBER: NCT02482844; Pre-results.

Myocardial Fractional Flow Reserve Measurement Using Contrast Media as a First-Line Assessment of Coronary Lesions in Current Practice.

BACKGROUND: Fractional flow reserve (FFR) measurement requires adenosine injection. However, adenosine can induce conductive and rhythmic complications, or be contraindicated in some patients. Contrast-induced hyperemia could provide a simple first-line method (contrast-enhanced FFR; cFFR) to assess coronary lesions. In this study we evaluated the accuracy of cFFR to predict lesion significance. METHODS: This prospective study included 104 patients with 138 coronary lesions. Each stenosis was evaluated using resting distal coronary pressure to aortic pressure ratio (Pd/Pa) measurements using intracoronary iodixanol (cFFR) and adenosine (FFR) injection. An FFR value ≤ 0.8 defined a significant lesion. RESULTS: Dose-ranging analysis (n = 12 lesions) showed that 10 mL iodixanol was required to obtain the lowest cFFR value. Intermeasurement reproducibility of cFFR (n = 18 lesions) showed limited variability and small mean estimated bias (0.001 ± 0.014). Values of cFFR and FFR were highly correlated in a first series of n = 36 lesions (r = 0.9; P < 0.001). Receiver-operating characteristic curve analysis showed an excellent accuracy of cFFR cutoff value of ≤ 0.85 in predicting FFR value ≤ 0.80 (area under the curve, 0.94; 95% confidence interval, 0.90-0.98; sensitivity, 95%; specificity, 73%). This threshold was then tested prospectively in an independent cohort of n = 72 lesions. A cFFR value ≤ 0.85 correctly identified hemodynamically significant lesions with a sensitivity of 100%, specificity of 78%, positive predictive value of 78%, and negative predictive value of 100%. CONCLUSIONS: cFFR is reproducible and can be achieved with usual volumes of contrast. A cFFR threshold value of 0.85 provides excellent sensitivity and negative predictive value in coronary artery stenosis.

Female gender is an independent predictor of in-hospital mortality after STEMI in the era of primary PCI: insights from the greater Paris area PCI Registry.

AIMS: To determine if female gender is an independent predictor of in-hospital mortality after percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction (STEMI). A higher early mortality rate after STEMI has been reported in women before the widespread use of PCI in STEMI. PCI improves the prognosis of STEMI, however, the effect of PCI in women in this setting is controversial. In a large regional prospective registry, we examined the in-hospital mortality after PCI for STEMI. METHODS AND RESULTS: The greater Paris area comprises 11 million inhabitants. Data from all PCIs performed in 41 centres is entered in a mandatory registry. In-hospital mortality is recorded in another hospital-based database. From 2003 to 2007, 16,760 patients were treated by PCI for STEMI <24 hours; 21.9% were women. Female patients were significantly older than men, 69.7 ± 14.3 years versus 59.3 ± 13.0 years (p<0.0001). The rate of diabetes mellitus and cardiogenic shock were significantly higher in women versus men, respectively 19.0% versus 15.6%, p<0.0001 and 6.7% versus 4.0%, p<0.0001. The success rate of PCI was significantly lower in women: 94.7% versus 95.9%, p=0.002. In-hospital mortality was significantly higher in women 9.8 % versus 4.3%, p<0.0001 and the impact of gender on mortality was significant only after the age of 75. By multivariate analysis, female gender is associated with higher in-hospital mortality. CONCLUSIONS: After PCI for STEMI, female gender is still an independent predictor of in-hospital mortality.

Comparison of 64-slice computed tomography planimetry and Doppler echocardiography in the assessment of aortic valve stenosis.

BACKGROUND AND AIM OF THE STUDY: The study aim was to compare, prospectively, the planimetry of aortic stenosis on 64-slice computed tomography (CT), with the area calculated by Doppler transthoracic echocardiography (TTE) in symptomatic patients evaluated before potential aortic valve replacement. METHODS: Fifty-two consecutive patients (27 males, 25 females; mean age 74 +/- 10 years) admitted to the authors' institution during 2005 were evaluated with 64-slice CT and Doppler TTE. The time interval between the two evaluations was 2 +/- 1 weeks. Planimetry of the anatomic orifice area (AOA) drawn on 64-slice CT was compared to the effective area determined by Doppler TTE by Bland and Altman analysis, and the anatomic area threshold value corresponding to a significant effective aortic stenosis (50.75 cm2) was determined by receiver operating characteristic (ROC) analysis. RESULTS: The aortic orifice area measured by 64-slice CT correlated well with the effective area (r = 0.76; p <0.0001), but was significantly greater, with a systematic overestimation (0.132 cm(2)) and a variability of 0.239 cm(2). There was good agreement between planimetry determined by two independent radiologists (difference = 0.002, variability = 0.115 cm(2)). ROC analysis showed that a threshold value of 0.95 cm(2) as measured by 64-slice CT planimetry identifies significant aortic stenosis with sensitivity, specificity, accuracy, positive and negative predictive values of 82%, 77%, 81%, 91% and 59%, respectively. CONCLUSION: 64-slice CT is a reproducible and reliable non-invasive method to evaluate aortic valve stenosis compared to the reference method of Doppler TTE. Indeed, the CT approach could replace the latter evaluation when measurements used in the continuity equation are inadequate.

Acute myocardial infarction early viability assessment by 64-slice computed tomography immediately after coronary angiography: comparison with low-dose dobutamine echocardiography.

OBJECTIVES: Early evaluation of myocardial viability in acute myocardial infarction is useful to guide therapy. Therefore, we assessed 64-slice computed tomography (CT) immediately after coronary angiography in this setting. BACKGROUND: Recent preliminary studies have shown the promising usefulness of late hyperenhancement multislice computed tomography (MSCT) for non-viability assessment. METHODS: Thirty-six patients admitted for a first acute myocardial infarction had a coronary angiogram early after admission followed by 64-slice CT without iodine reinjection. The 16 segments of the left ventricle depicted by the American Society of Echocardiography were graded: no, subendocardial, or transmural hyperenhancement. No or subendocardial hyperenhancement were expected to reflect viability. Two to 4 weeks later, the same segments' contractility was evaluated at rest. Low-dose dobutamine echocardiography was performed in case of akinetic segment at rest. RESULTS: Mean delay between coronary angiography and MSCT was 24 +/- 11 min (range 7 to 51 min). We compared 576 segments evaluated by each method. Agreement was noted for 560 segments (97%) and disagreement for 16 segments (3%). Thus, 64-slice CT after coronary angiography for an acute myocardial infarction had 98% sensitivity, 94% specificity, 97% accuracy, and 99% positive and 79% negative predictive values for detecting viable myocardial segments at a very early stage of an acute myocardial infarction. On a per-patient analysis, sensitivity, specificity, accuracy, and positive and negative predictive values were 92%, 100%, 94%, and 100% and 85%, respectively. CONCLUSIONS: A 64-slice CT after coronary angiography for an acute myocardial infarction is a promising method for early evaluation of viable myocardium.