Transapical Mitral Valve Replacement: 1-Year Results of the Real-World Tendyne European Experience Registry.

BACKGROUND: Early studies of the Tendyne transcatheter mitral valve replacement (TMVR) showed promising results in a small selective cohort. OBJECTIVES: The authors present 1-year data from the currently largest commercial, real-world cohort originating from the investigator-initiated TENDER (Tendyne European Experience) registry. METHODS: All patients from the TENDER registry eligible for 1-year follow-up were included. The primary safety endpoint was 1-year cardiovascular mortality. Primary performance endpoint was reduction of mitral regurgitation (MR) up to 1 year. RESULTS: Among 195 eligible patients undergoing TMVR (median age 77 years [Q1-Q3: 71-81 years], 60% men, median Society of Thoracic Surgeons Predicted Risk of Mortality 5.6% [Q1-Q3: 3.6%-8.9%], 81% in NYHA functional class III or IV, 94% with MR 3+/4+), 31% had "real-world" indications for TMVR (severe mitral annular calcification, prior mitral valve treatment, or others) outside of the instructions for use. The technical success rate was 95%. The cardiovascular mortality rate was 7% at 30 day and 17% at 1 year (all-cause mortality rates were 9% and 29%, respectively). Reintervention or surgery following discharge was 4%, while rates of heart failure hospitalization reduced from 68% in the preceding year to 25% during 1-year follow-up. Durable MR reduction to ≤1+ was achieved in 98% of patients, and at 1 year, 83% were in NYHA functional class I or II. There was no difference in survival and major adverse events between on-label use and "real-world" indications up to 1 year. CONCLUSIONS: This large, real-world, observational registry reports high technical success, durable and complete MR elimination, significant clinical benefits, and a 1-year cardiovascular mortality rate of 17% after Tendyne TMVR. Outcomes were comparable between on-label use and "real-world" indications, offering a safe and efficacious treatment option for patients without alternative treatments. (Tendyne European Experience Registry [TENDER]; NCT04898335).

Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience.

AIMS: Transcatheter mitral valve implantation (TMVI) is a new treatment option for patients with symptomatic mitral valve (MV) disease. Real-world data have not yet been reported. This study aimed to assess procedural and 30-day outcomes of TMVI in a real-world patient cohort. METHOD AND RESULTS: All consecutive patients undergoing implantation of a transapically delivered self-expanding valve at 26 European centres from January 2020 to April 2021 were included in this retrospective observational registry. Among 108 surgical high-risk patients included (43% female, mean age 75 ± 7 years, mean STS-PROM 7.2 ± 5.3%), 25% was treated for an off-label indication (e.g. previous MV intervention or surgery, mitral stenosis, mitral annular calcification). Patients were highly symptomatic (New York Heart Association [NYHA] functional class III/IV in 86%) and mitral regurgitation (MR) was graded 3+/4+ in 95% (38% primary, 37% secondary, and 25% mixed aetiology). Technical success rate was 96%, and MR reduction to ≤1+ was achieved in all patients with successful implantation. There were two procedural deaths and 30-day all-cause mortality was 12%. At early clinical follow-up, MR reduction was sustained and there were significant reductions of pulmonary pressure (systolic pulmonary artery pressure 52 vs. 42 mmHg, p < 0.001), and tricuspid regurgitation severity (p = 0.013). Heart failure symptoms improved significantly (73% in NYHA class I/II, p < 0.001). Procedural success rate according to MVARC criteria was 80% and was not different in patients treated for an off-label indication (74% vs. 81% for off- vs. on-label, p = 0.41). CONCLUSION: In a real-world patient population, TMVI has a high technical and procedural success rate with efficient and durable MR reduction and symptomatic improvement.

Dynamic Myocardial Perfusion CT for the Detection of Hemodynamically Significant Coronary Artery Disease.

OBJECTIVES: In this international, multicenter study, using third-generation dual-source computed tomography (CT), we investigated the diagnostic performance of dynamic stress CT myocardial perfusion imaging (CT-MPI) in addition to coronary CT angiography (CTA) compared to invasive coronary angiography (ICA) and invasive fractional flow reserve (FFR). BACKGROUND: CT-MPI combined with coronary CTA integrates coronary artery anatomy with inducible myocardial ischemia, showing promising results for the diagnosis of hemodynamically significant coronary artery disease in single-center studies. METHODS: At 9 centers in Europe, Japan, and the United States, 132 patients scheduled for ICA were enrolled; 114 patients successfully completed coronary CTA, adenosine-stress dynamic CT-MPI, and ICA. Invasive FFR was performed in vessels with 25% to 90% stenosis. Data were analyzed by independent core laboratories. For the primary analysis, for each coronary artery the presence of hemodynamically significant obstruction was interpreted by coronary CTA with CT-MPI compared to coronary CTA alone, using an FFR of ≤0.80 and angiographic severity as reference. Territorial absolute myocardial blood flow (MBF) and relative MBF were compared using C-statistics. RESULTS: ICA and FFR identified hemodynamically significant stenoses in 74 of 289 coronary vessels (26%). Coronary CTA with ≥50% stenosis demonstrated a per-vessel sensitivity, specificity, and accuracy for the detection of hemodynamically significant stenosis of 96% (95% CI: 91%-100%), 72% (95% CI: 66%-78%), and 78% (95% CI: 73%-83%), respectively. Coronary CTA with CT-MPI showed a lower sensitivity (84%; 95% CI: 75%-92%) but higher specificity (89%; 95% CI: 85%-93%) and accuracy (88%; 95% CI: 84%-92%). The areas under the receiver-operating characteristic curve of absolute MBF and relative MBF were 0.79 (95% CI: 0.71-0.86) and 0.82 (95% CI: 0.74-0.88), respectively. The median dose-length product of CT-MPI and coronary CTA were 313 mGy·cm and 138 mGy·cm, respectively. CONCLUSIONS: Dynamic CT-MPI offers incremental diagnostic value over coronary CTA alone for the identification of hemodynamically significant coronary artery disease. Generalized results from this multicenter study encourage broader consideration of dynamic CT-MPI in clinical practice. (Dynamic Stress Perfusion CT for Detection of Inducible Myocardial Ischemia [SPECIFIC]; NCT02810795).

Dual-axis rotational coronary angiography versus conventional coronary angiography: a randomized comparison.

BACKGROUND: Dual-axis of rotational coronary angiography (RA), with one single cine acquisition during continuous C-arm motion along a pre-described path, is an alternative to conventional coronary angiography (CA). We assessed the performance of RA versus CA in a modern, experienced cath lab setting. METHODS: Sixty-seven patients with suspected coronary artery disease undergoing invasive coronary angiography were randomized to CA (n = 35) or dual-axis RA (n = 32). CA was performed with four left and two right coronary artery acquisitions with manual contrast medium injection. In RA, one cine acquisition each was performed for the left (5 projections) and right coronary artery (3 projections) with a fixed amount of contrast medium applied by a power injector. In both groups, single cine acquisitions in additional angulations were performed to fully interpret the coronary system, if necessary. Procedural parameters and outcome were compared. RESULTS: Mean age was 63 ± 12 years (64% males). Six additional projections were required in the RA group compared to 13 in the CA group (p = 0.173). Fluoroscopy duration (CA: 3 ± 3 min, RA: 3 ± 2 min, p = 0.748) and dose area product (CA: 1291 ± 761 µGym2, RA: 1476 ± 679 µGym2, p = 0.235) did not differ significantly between both groups. For CA, the amount of contrast medium (42 ± 13 vs. 46 ± 8 ml, p = 0.022) and procedure time (8 ± 5 vs. 11 ± 3 min, p < 0.001) were significantly lower. No major adverse event occurred during hospital stay. CONCLUSIONS: Dual-axis RA represents a feasible and safe alternative method to CA for obtaining coronary angiograms. However, no superiority was observed when performed by an experienced interventionalist with a modern system.

Magnetic resonance phase contrast velocity mapping for flow quantification in irregular heart rhythms using radial k-space ultrashort echo time imaging.

BACKGROUND: Phase contrast velocity mapping sequences utilising ultrashort echo time (UTE) radial k-space sequences have been used to reduce intravoxel dephasing at high velocities. We evaluated the accuracy of the UTE flow sequence for mitral regurgitation (MR) quantification, including patients with atrial fibrillation. METHODS: Forty patients underwent cardiac MRI for indirect MR quantification by assessment of aortic flow using a UTE phase contrast sequence (TE 0.65 ms) combined with left ventricular stroke volume. Retrospective ECG-gating was used in sinus rhythm (30 patients), prospective ECG-triggering in atrial fibrillation (10). MR was also quantified by a standard phase contrast sequence (TE 2.85 ms, standard flow method) and by comparing stroke volumes (volumetric method). RESULTS: UTE flow-derived MR measurement showed modest agreement in sinus rhythm (95% limits of agreement: ±38.2 ml; ±29.8%) and atrial fibrillation (±33.7 ml; ±30.3%) compared to standard flow assessment. There was little systematic bias in sinus rhythm (mean offset -4.4 ml /-3.5% compared to standard flow assessment), but a slight bias towards greater regurgitation in atrial fibrillation (+15.2 ml /+14.0%). There were wider limits of agreement between the UTE flow method and volumetric method than between the regular flow method and the volumetric method in sinus rhythm (±48.4 ml; ±36.4%; mean offset: -12.2 ml /-9.0%) and similar limits of agreement in atrial fibrillation (±29.6 ml; 25.8%; +12.0 ml /+10.3%). CONCLUSIONS: UTE flow imaging is inferior to conventional flow techniques for MR assessment in patients with sinus rhythm as well as atrial fibrillation. However, the number of atrial fibrillation patients in this initial study is small.

Computer-aided evaluation of low-dose and low-contrast agent third-generation dual-source CT angiography prior to transcatheter aortic valve implantation (TAVI).

PURPOSE: To evaluate the performance of computer-aided evaluation software for a comprehensive workup of patients prior to transcatheter aortic valve implantation (TAVI) using low-contrast agent and low radiation dose third-generation dual-source CT angiography. METHODS: We evaluated 30 consecutive patients scheduled for TAVI. All patients underwent ECG-triggered high-pitch dual-source CT angiography of the aortic root and aorta with a standardized contrast agent volume (30 ml Imeron350, flow rate 4 ml/s) and low-dose (100 kv/350 mAs) protocol. An expert (10 years of experience) manually evaluated aortic root and iliac access dimensions (distance between coronary ostia and aortic annulus, minimal/maximal diameters and area-derived diameter of the aortic annulus) and best CT-predicted fluoroscopic projection angle as the reference standard. Utilizing computer-aided software (syngo.via), the same pre-TAVI workup was performed and compared to the reference standard. RESULTS: Mean CTDI[Formula: see text] was 3.46 mGy and mean DLP 217.6 ± 12.1 mGy cm, corresponding to a mean effective dose of 3.7 ± 0.2 mSv. Computer-aided evaluation was successful in all but one patient. Compared to the reference standard, Bland-Altman analysis indicated very good agreement for the distances between aortic annulus and coronary ostia (RCA: mean difference 0.8 mm; 95 % CI 0.4-1.2 mm; LM: mean difference 0.9 mm; 95 % CI 0.5-1.3 mm); however, we demonstrated a systematic overestimation of annulus- derived diameter using the software (mean difference 44.4 mm[Formula: see text]; 95 % CI 30.4-58.3 mm[Formula: see text]). Based on respective annulus dimensions, the recommended prosthesis size (Edwards SAPIEN 3) matched in 26 out of the 29 patients (90 %). CT-derived fluoroscopic projection angles showed an excellent agreement for both methods. Out of 58 iliac arteries, 15 (25 %) arteries could not be segmented by the software. Preprocessing time of the software was 71 ± 11 s (range 51-96 s), and reading time with the software was 118 ± 31 s (range 68-201 s). CONCLUSION: In the workup of pre-TAVI CT angiography, computer-aided evaluation of low-contrast, low-dose examinations is feasible with good agreement and quick reading time. However, a systematic overestimation of the aortic annulus area is observed.

Prediction of fluoroscopic angulations for transcatheter aortic valve implantation by CT angiography: influence on procedural parameters.

AIMS: Repeated angiograms to achieve an exactly orthogonal visualization of the aortic valve plane can substantially contribute to the total contrast amount required for transcatheter aortic valve implantation (TAVI). We investigated whether pre-procedural identification of an optimal fluoroscopic projection by cardiac computed tomography (CT) can significantly reduce the amount of a procedure-related contrast agent compared with angiographic determination of suitable angulations. METHODS AND RESULTS: Eighty consecutive patients (81 ± 5 years, 55% male) with symptomatic severe aortic valve stenosis and normal renal function who underwent cardiac CT prior to TAVI were prospectively randomized. In 40 patients, a CT-predicted suitable angulation was used for the first aortic angiogram (CT cohort); in the other 40 patients, the first aortogram was acquired at LAO 10°/cranial 10 (angiography cohort). Additional aortograms were performed if no satisfactory view of the aortic valve plane was obtained. The number of aortograms needed to achieve a satisfactory fluoroscopic projection (1.2 ± 0.6 vs. 3.2 ± 1.7; P < 0.001) and the total amount of contrast agent per TAVI procedure were significantly lower in the CT cohort (95 ± 21 vs. 125 ± 36 mL; P < 0.001). Incidence of acute kidney injury was not significantly different. There was no significant difference regarding radiation dose, time of procedure, degree of post-procedural aortic regurgitation, complications and 30-day mortality between the cohorts. CONCLUSION: Pre-procedural identification of a suitable fluoroscopic projection by cardiac CT significantly reduces a procedural contrast agent volume required for TAVI.

Contrast volume reduction using third generation dual source computed tomography for the evaluation of patients prior to transcatheter aortic valve implantation.

OBJECTIVES: Chronic renal failure is common in patients referred for transcatheter aortic valve implantation (TAVI). CT angiography is recommended and provides crucial information prior to TAVI. We evaluated the feasibility of a reduced contrast volume protocol for pre-procedural CT imaging. METHODS: Forty consecutive patients were examined with prospectively ECG-triggered high-pitch spiral acquisition using a novel third-generation dual-source CT system; 38 ml contrast agent was used. Image quality was graded on a visual scale (1-4). Contrast attenuation was measured at the level of the aortic root and at the iliac bifurcation. RESULTS: Mean patient age was 82 ± 6 years (23 males; 58 %). Mean attenuation/average image quality was 285 ± 60 HU/1.5 at the aortic annulus compared to 289 ± 74 HU/1.8 at the iliac bifurcation (p = 0.77/p = 0.29). Mean estimated effective radiation dose was 2.9 ± 0.3 mSv. A repeat acquisition was necessary in one patient due to image quality. Out of the 35 patients who underwent TAVI, 31 (89 %) patients had no or mild aortic regurgitation. Thirty-two (91 %) patients were discharged successfully. CONCLUSION: Pre-procedural CTA with a total of 38 ml contrast volume is feasible and clinically useful, using third-generation dual-source CT, allowing comprehensive imaging for procedural success. KEY POINTS: • Reduction of contrast agent volume is crucial in patients with chronic renal failure. • Novel third-generation computed tomography helps to reduce contrast agent volume. • Pre-procedural CT allows comprehensive imaging for procedural success before heart valve implantation. • A low-contrast CT protocol is feasible for pre-procedural TAVI planning.

Prospectively ECG-triggered high-pitch coronary angiography with third-generation dual-source CT at 70 kVp tube voltage: feasibility, image quality, radiation dose, and effect of iterative reconstruction.

BACKGROUND: Low tube voltage reduces radiation exposure in coronary CT angiography (CTA). Using 70 kVp tube potential has so far not been possible because CT systems were unable to provide sufficiently high tube current with low voltage. OBJECTIVE: We evaluated feasibility, image quality (IQ), and radiation dose of coronary CTA using a third-generation dual-source CT system capable of producing 450 mAs tube current at 70 kVp tube voltage. METHODS: Coronary CTA was performed in 26 consecutive patients with suspected coronary artery disease, selected for body weight <100 kg and heart rate <60 beats/min. High-pitch spiral acquisition was used. Filtered back projection (FBP) and iterative reconstruction (IR) algorithms were applied. IQ was assessed using a 4-point rating scale (1 = excellent, 4 = nondiagnostic) and objective parameters. RESULTS: Mean age was 62 ± 9 years (46% males; mean body mass index, 27.7 ± 3.8 kg/m(2); mean heart rate, 54 ± 5 beats/min). Mean dose-length product was 20.6 ± 1.9 mGy × cm; mean estimated effective radiation dose was 0.3 ± 0.03 mSv. Diagnostic IQ was found in 365 of 367 (FBP) and 366 of 367 (IR) segments (P nonsignificant). IQ was rated "excellent" in 53% (FBP) and 86% (IR) segments (P = .001) and "nondiagnostic" in 2 (FBP) and 1 segment (IR) (P nonsignificant). Mean IQ score was lesser in FBP vs IR (1.5 ± 0.4 vs 1.1 ± 0.2; P < .001). Image noise was lower in IR vs FBP (60 ± 10 HU vs 74 ± 8 HU; P < .001). CONCLUSION: In patients <100 kg and with a regular heart rate <60 beats/min, third-generation dual-source CT using high-pitch spiral acquisition and 70 kVp tube voltage is feasible and provides both robust IQ and very low radiation exposure.