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).

Ultrahigh-Spatial-Resolution Photon-counting Detector CT Angiography of Coronary Artery Disease for Stenosis Assessment.

Background Coronary CT angiography is a first-line test in coronary artery disease but is limited by severe calcifications. Photon-counting-detector (PCD) CT improves spatial resolution. Purpose To investigate the effect of improved spatial resolution on coronary stenosis assessment and reclassification. Materials and Methods Coronary stenoses were evaluated prospectively in a vessel phantom (in vitro) containing two stenoses (25%, 50%), and retrospectively in patients (in vivo) who underwent ultrahigh-spatial-resolution cardiac PCD CT (from July 2022 to April 2023). Images were reconstructed at standard resolution (section thickness, 0.6 mm; increment, 0.4 mm; Bv44 kernel), high spatial resolution (section thickness, 0.4 mm; increment, 0.2 mm; Bv44 kernel), and ultrahigh spatial resolution (section thickness, 0.2; increment, 0.1 mm; Bv64 kernel). Percentages of diameter stenosis (DS) were compared between reconstructions. In vitro values were compared with the manufacturer specifications of the phantom and patient results were assessed regarding effects on Coronary Artery Disease Reporting and Data System (CAD-RADS) reclassification. Results The in vivo sample included 114 patients (mean age, 68 years ± 9 [SD]; 71 male patients). In vitro percentage DS measurements were more accurate with increasing spatial resolution for both 25% and 50% stenoses (mean bias for standard resolution, high spatial resolution, and ultrahigh spatial resolution, respectively: 10.1%, 8.0%, and 2.3%; P < .001). In vivo results confirmed decreasing median percentage DS with increasing spatial resolution for calcified stenoses (n = 161) (standard resolution, high spatial resolution, and ultrahigh spatial resolution, respectively: 41.5% [IQR, 27.3%-58.2%], 34.8% [IQR, 23.7%-55.1%], and 26.7% [IQR, 18.6%-44.3%]; P < .001), whereas noncalcified (n = 13) and mixed plaques (n = 19) did not show evidence of a difference (P ≥ .88). Ultrahigh-spatial-resolution reconstructions led to reclassification of 62 of 114 (54.4%) patients to lower CAD-RADS category than that assigned using standard resolution. Conclusion In vivo and in vitro coronary stenosis assessment improved for calcified stenoses by using ultrahigh-spatial-resolution PCD CT reconstructions, leading to lower percentage DS compared with standard resolution and clinically relevant rates of reclassification. © RSNA, 2024 Supplemental material is available for this article. See also the editorial by McCollough in this issue.

Photon-Counting Detector CT Virtual Monoenergetic Images for Coronary Artery Stenosis Quantification: Phantom and In Vivo Evaluation.

BACKGROUND. Calcium blooming causes stenosis overestimation on coronary CTA. OBJECTIVE. The purpose of this article was to evaluate the impact of virtual monoenergetic imaging (VMI) reconstruction level on coronary artery stenosis quantification using photon-counting detector (PCD) CT. METHODS. A phantom containing two custom-made vessels (representing 25% and 50% stenosis) underwent PCD CT acquisitions without and with simulated cardiac motion. A retrospective analysis was performed of 33 patients (seven women, 26 men; mean age, 71.3 ± 9.0 [SD] years; 64 coronary artery stenoses) who underwent coronary CTA by PCD CT followed by invasive coronary angiography (ICA). Scans were reconstructed at nine VMI energy levels (40-140 keV). Percentage diameter stenosis (PDS) was measured, and bias was determined from the ground-truth stenosis percentage in the phantom and ICA-derived quantitative coronary angiography measurements in patients. Extent of blooming artifact was measured in the phantom and in calcified and mixed plaques in patients. RESULTS. In the phantom, PDS decreased for 25% stenosis from 59.9% (40 keV) to 13.4% (140 keV) and for 50% stenosis from 81.6% (40 keV) to 42.3% (140 keV). PDS showed lowest bias for 25% stenosis at 90 keV (bias, 1.4%) and for 50% stenosis at 100 keV (bias, -0.4%). Blooming artifacts decreased for 25% stenosis from 61.5% (40 keV) to 35.4% (140 keV) and for 50% stenosis from 82.7% (40 keV) to 52.1% (140 keV). In patients, PDS for calcified plaque decreased from 70.8% (40 keV) to 57.3% (140 keV), for mixed plaque decreased from 69.8% (40 keV) to 56.3% (140 keV), and for noncalcified plaque was 46.6% at 40 keV and 54.6% at 140 keV. PDS showed lowest bias for calcified plaque at 100 keV (bias, 17.2%), for mixed plaque at 140 keV (bias, 5.0%), and for noncalcified plaque at 40 keV (bias, -0.5%). Blooming artifacts decreased for calcified plaque from 78.4% (40 keV) to 48.6% (140 keV) and for mixed plaque from 73.1% (40 keV) to 44.7% (140 keV). CONCLUSION. For calcified and mixed plaque, stenosis severity measurements and blooming artifacts decreased at increasing VMI reconstruction levels. CLINICAL IMPACT. PCD CT with VMI reconstruction helps overcome current limitations in stenosis quantification on coronary CTA.

Cardiac CT Beyond Coronaries: Focus on Structural Heart Disease.

PURPOSE OF REVIEW: Cardiac computed tomography (CT) is an established non-invasive imaging tool for the assessment of coronary artery disease. Furthermore, it plays a key role in the preinterventional work-up of patients presenting with structural heart disease. RECENT FINDINGS: CT is the gold standard for preprocedural annular assessment, device sizing, risk determination of annular injury, coronary occlusion or left ventricular outflow tract obstruction, calcification visualization and quantification of the target structure, and prediction of a co-planar fluoroscopic angulation for transcatheter interventions in patients with structural heart disease. It is further a key imaging modality in postprocedural assessment for prosthesis thrombosis, degeneration, or endocarditis. CT plays an integral part in the imaging work-up of novel transcatheter therapies for structural heart disease and postprocedural assessment for prosthesis thrombosis or endocarditis. This review provides a comprehensive overview of the key role of CT in the context of structural heart interventions.

Optimization of Kernel Type and Sharpness Level Improves Objective and Subjective Image Quality for High-Pitch Photon Counting Coronary CT Angiography.

(1) Background: Photon-counting detector (PCD) CT offers a wide variety of kernels and sharpness levels for image reconstruction. The aim of this retrospective study was to determine optimal settings for coronary CT angiography (CCTA). (2) Methods: Thirty patients (eight female, mean age 63 ± 13 years) underwent PCD-CCTA in a high-pitch mode. Images were reconstructed using three different kernels and four sharpness levels (Br36/40/44/48, Bv36/40/44/48, and Qr36/40/44/48). To analyze objective image quality, the attenuation, image noise, contrast-to-noise ratio (CNR), and vessel sharpness were quantified in proximal and distal coronaries. For subjective image quality, two blinded readers assessed image noise, visually sharp reproduction of coronaries, and the overall image quality using a five-point Likert scale. (3) Results: Attenuation, image noise, CNR, and vessel sharpness significantly differed across kernels (all p < 0.001), with the Br-kernel reaching the highest attenuation. With increasing kernel sharpness, image noise and vessel sharpness increased, whereas CNR continuously decreased. Reconstruction with Br-kernel generally had the highest CNR (Br > Bv > Qr), except Bv-kernel had a superior CNR at sharpness level 40. Bv-kernel had significantly higher vessel sharpness than Br- and Qr-kernel (p < 0.001). Subjective image quality was rated best for kernels Bv40 and Bv36, followed by Br36 and Qr36. (4) Conclusion: Reconstructions with kernel Bv40 are beneficial to achieve optimal image quality in spectral high-pitch CCTA using PCD-CT.

Survival benefit of overweight patients undergoing MitraClip® procedure in comparison to normal-weight patients.

BACKGROUND: The number of MitraClip® implantations increased significantly in recent years. Data regarding the impact of weight class on survival are sparse. HYPOTHESIS: We hypothesized that weight class influences survival of patients treated with MitraClip® implantation. METHODS: We investigated in-hospital, 1-year, 3-year, and long-term survival of patients successfully treated with isolated MitraClip® implantation for mitral valve regurgitation (MR) (June 2010-March 2018). Patients were categorized by weight classes, and the impact of weight classes on survival was analyzed. RESULTS: Of 617 patients (aged 79.2 years; 47.3% females) treated with MitraClip® implantation (June 2010-March 2018), 12 patients were underweight (2.2%), 220 normal weight (40.1%), 237 overweight (43.2%), and 64 obesity class I (11.7%), 12 class II (2.2%), and 4 class III (0.7%). Preprocedural Logistic EuroScore (21.1 points [IQR 14.0-37.1]; 26.0 [18.5-38.5]; 26.0 [18.4-39.9]; 24.8 [16.8-33.8]; 33.0 [25.9-49.2]; 31.6 [13.1-47.6]; p = .291) was comparable between groups. Weight class had no impact on in-hospital death (0.0%; 4.1%; 1.5%; 0.0%; 7.7%; 0.0%; p = .189), 1-year survival (75.0%; 72.0%; 76.9%; 75.0%; 75.0%; 33.3%; p = .542), and 3-year survival (40.0%; 36.8%; 38.2%; 48.6%; 20.0%; 33.3%; p = .661). Compared to normal weight, underweight (hazard ratio [HR]: 1.35 [95% confidence interval [CI]: 0.65-2.79], p = .419), obesity-class I (HR: 0.93 [95% CI: 0.65-1.34], p = .705), class II (HR: 0.39 [95% CI: 0.12-1.24], p = .112), and class III (HR: 1.28 [95% CI: 0.32-5.21], p = .726) did not affect long-term survival. In contrast, overweight was associated with better survival (HR: 1.32 [95% CI: 1.04-1.68], p = .023). CONCLUSION: Overweight affected the long-term survival of patients undergoing MitraClip® implantation beneficially compared to normal weight.

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).

Intra-individual comparison of coronary calcium scoring between photon counting detector- and energy integrating detector-CT: Effects on risk reclassification.

Purpose: To compare coronary artery calcium volume and score (CACS) between photon-counting detector (PCD) and conventional energy integrating detector (EID) computed tomography (CT) in a phantom and prospective patient study. Methods: A commercially available CACS phantom was scanned with a standard CACS protocol (120 kVp, slice thickness/increment 3/1.5 mm, and a quantitative Qr36 kernel), with filtered back projection on the EID-CT, and with monoenergetic reconstruction at 70 keV and quantum iterative reconstruction off on the PCD-CT. The same settings were used to prospectively acquire data in patients (n = 23, 65 ± 12.1 years), who underwent PCD- and EID-CT scans with a median of 5.5 (3.0-12.5) days between the two scans in the period from August 2021 to March 2022. CACS was quantified using a commercially available software solution. A regression formula was obtained from the aforementioned comparison and applied to simulate risk reclassification in a pre-existing cohort of 514 patients who underwent a cardiac EID-CT between January and December 2021. Results: Based on the phantom experiment, CACS PCD-CT showed a more accurate measurement of the reference CAC volumes (overestimation of physical volumes: PCD-CT 66.1 ± 1.6% vs. EID-CT: 77.2 ± 0.5%). CACS EID-CT and CACS PCD-CT were strongly correlated, however, the latter measured significantly lower values in the phantom (CACS PCD-CT : 60.5 (30.2-170.3) vs CACS EID-CT 74.7 (34.6-180.8), p = 0.0015, r = 0.99, mean bias -9.7, Limits of Agreement (LoA) -36.6/17.3) and in patients (non-significant) (CACS PCD-CT : 174.3 (11.1-872.7) vs CACS EID-CT 218.2 (18.5-876.4), p = 0.10, r = 0.94, mean bias -41.1, LoA -315.3/232.5). The systematic lower measurements of Agatston score on PCD-CT system led to reclassification of 5.25% of our simulated patient cohort to a lower classification class. Conclusion: CACS PCD-CT is feasible and correlates strongly with CACS EID-CT , however, leads to lower CACS values. PCD-CT may provide results that are more accurate for CACS than EID-CT.

Transgastric imaging-The key to successful periprocedural TEE guiding for edge-to-edge repair of the tricuspid valve.

Intraprocedural transesophageal echocardiography (TEE) guidance plays an essential role in transcatheter repair therapy of the tricuspid valve (TV). So far, several different imaging concepts are in use. We propose an imaging protocol that fully addresses the morphological complexity of the TV and further offers efficacious workarounds for the frequently occurring restrictions of TV imaging in edge-to-edge repair of the TV. As a tertiary referral center with a large experience of more than 250 cases of transcatheter edge-to-edge repair (TEER) of the TV performed at the Heart Valve Center in Mainz/Germany, we have constantly adapted our peri-interventional echocardiographic approach to accomplish both. As a key measure for success, we intensely rely on the transgastric acoustic windows that not only deliver high-resolution information on the morphology of the TV and all relevant procedural steps but also help to avoid the frequent shadowing artifacts experienced in transesophageal imaging.

Early symptomatic benefit indicates long-term prognosis after transcatheter mitral valve edge-to-edge repair in functional and degenerative etiology.

BACKGROUND: Mitral regurgitation (MR) is common in patients with heart failure and constitutes an independent risk factor for adverse prognosis besides NYHA-class. The predictive value of dyspnea reduction after transcatheter mitral valve repair (TMVr) on outcome has not been investigated up to now. METHODS AND RESULTS: We enrolled 627 consecutive patients (47.0% female, 57.4% functional MR; median follow-up 486 days[IQR 157/961]; survival status available in 96.8%; symptoms assessed in n = 556 at baseline / n = 406 at 1 month) treated with isolated percutaneous mitral valve edge-to-edge repair in our center from 06/2010-03/2018 (exclusion of combined forms of TMVr) in a monocentric retrospective analysis. Survival was 97.6% at discharge, 73.9% after 1, 54.5% after 3, 37.6% after 5 and 21.7% after 7-years. Before TMVr, NYHA-classes III/IV were found in 89.0%. Of these, 74.7% reported symptomatic relief (reduction in NYHA-class) one month after procedure (NYHA class recorded in 406 patients at 30 days). NYHA-classes III/IV were documented in 37.2% (p < 0.001) at 30 days and in 36.6% (p < 0.001) at 1 year without significant changes between the follow-ups. Dyspnea reduction was accompanied by significantly improved long-term survival (1 year, 89.1 vs 71.2%, p = 0.001, 2 years: 75.5 vs 58.7%, p = 0.039) and was identified as an independent predictor for lower mortality (1-year HR for increased mortality by missing symptomatic improvement 2.94 [95%CI 1.53-5.65], p = 0.001; long-term HR 1.95 [95%CI 1.29-2.94], p = 0.001) independently in both etiologies of MR. CONCLUSION: TMVr by edge-to-edge therapy enables early and sustainable symptomatic improvement in nearly 75% of the symptomatic patients. The simple assessment of postinterventional changes in NYHA-class might serve as an independent predictor for mid- and long-term prognosis in both FMR and DMR.

Complications Following MitraClip Implantation.

PURPOSE OF REVIEW: To provide a detailed overview of complications associated with MitraClip therapy and its development over time with the aim to alert physicians for early recognition of complications and to offer treatment strategies for each complication, if possible. RECENT FINDINGS: The MitraClip system (MC) is the leading transcatheter technique to treat mitral regurgitation (MR) and has been established as a safe procedure with very low adverse event rates compared to mitral surgery at intermediate to high risk or in secondary MR. Lately, the fourth MC generation has been launched with novel technical features to facilitate device handling, decrease complication rates, and allow the treatment of even complex lesions. Although the complication rate is low, adverse events are associated with increased morbidity and mortality. The most common complications are bleeding, acute kidney failure, procedure-induced mitral stenosis, and an iatrogenic atrial septal defect with unknown clinical impact.

Analysis of left ventricular function, left ventricular outflow tract and aortic valve area using computed tomography: Influence of reconstruction parameters on measurement accuracy.

OBJECTIVES: Computed tomography (CT) allows reproducible assessment of left ventricular (LV) function, left ventricular outflow tract area (LVOTarea) and aortic valve area (AVA). We evaluated the influence of image reconstruction parameters on these measurements. METHODS: We analyzed 45 contrast-enhanced, retrospectively ECG-gated CT datasets acquired on a third-generation dual source system. A standard filtered-back-projection data set (20 cardiac phases (5% steps, 0-95%), 0.6-mm-slice thickness, 512 × 512 matrix) and eight reconstructions with modified slice thickness (1-8 mm), number of cardiac phases (5, 10), matrix size (256×256) and an iterative reconstruction (IR) algorithm were obtained. LV parameters (ejection fraction (EF), stroke volume (SV), end-diastolic (EDV), end-systolic volumes (ESV)), LVOTarea and AVA were assessed. RESULTS: Differences in LV parameters, LVOTarea and AVA, were only minimal between standard reconstructions and those with modified matrix size, IR algorithm and ≤2 mm slice thickness, while reconstructions with 8-mm slice thickness significantly overestimated SV (p < 0.001) and EDV (p = 0.016). AVA planimetry in reconstructions with ≥5 mm slice thickness was not feasible in 56% of patients. A decrease in the number of reconstructed phases (10 or 5) underestimated EF, SV, EDV, LVOTarea and AVA and overestimated ESV. CONCLUSIONS: Modifications of reconstruction parameters (except a slice thickness ≤2 mm) have only a marginal effect on LV, LVOTarea and AVA assessment. However, a reduced number of reconstructions per cardiac cycle may significantly influence measurements. ADVANCES IN KNOWLEDGE: Substantial modifications in number of reconstructions per cardiac cycle significantly affect the assessment of LV function, LVOTarea and AVA also in modern CT scanners.

Short-Term Clinical Outcomes of Transcatheter Tricuspid Valve Repair With the Third-Generation MitraClip XTR System.

OBJECTIVES: The aim of this study was to assess 30-day outcomes of transcatheter edge-to-edge repair with the MitraClip XTR for significant tricuspid regurgitation (TR), relative to baseline coaptation gap sizes (CGS). BACKGROUND: Transcatheter edge-to-edge repair using the MitraClip NT for patients with significant TR is safe and efficacious; the utility of the MitraClip XTR is unknown. METHODS: Patients with significant, symptomatic TR treated at a single site between April 2018 and December 2019, with consent and with complete data, were included (n = 50). Baseline and 30-day echocardiograms were assessed by an echocardiography core laboratory. Patients were divided into 3 subgroups on the basis of site-assessed CGS: subgroup I (< 7 mm), subgroup II (7 to 10 mm), and subgroup III (>10 mm). RESULTS: Technical success of the MitraClip XTR implantation was 100% (88% in the septal-anterior position) using a median of 2 clips (interquartile range: 1 to 2). At 30 days, single-leaflet detachment was noted in 3 patients (6%), with no instances of device embolization. TR was reduced by 1 grade in subgroup I and by 2 grades in subgroups II and III. New York Heart Association functional class was reduced by 1 class in all 3 subgroups. The 6-min walk distance increased in subgroup I (+115 m; p = 0.014) and subgroup II (+31.5 m; p = 0.028) but not subgroup III (+50 m; p = 0.999). A CGS of ≤8.4 mm was predictive of a reduction to moderate or less TR. CONCLUSIONS: MitraClip XTR implantation is a safe, effective treatment for a wider range of CGS in patients with symptomatic, significant TR than prior device iterations. All patients showed improvement in New York Heart Association functional class, and those with CGS <10 mm also experienced improved functional capacity.

Minimizing Paravalvular Regurgitation With the Novel SAPIEN 3 Ultra TAVR Prosthesis: A Real-World Comparison Study.

Objectives: We investigated performance and outcome of the latest-generation balloon-expandable SAPIEN 3 Ultra prosthesis (S3U) compared to the established SAPIEN 3 prosthesis (S3) in a real-world cohort, with focus on paravalvular regurgitation (PVR). Background: PVR is an adverse prognostic indicator of short- and long-term survival after transcatheter aortic valve replacement (TAVR). The S3U has been designed to improve sealing. Methods: We enrolled 343 consecutive patients presenting with severe native aortic valve stenosis eligible for a balloon-expandable prosthesis. The established S3 was implanted in the first 200 patients, the following 143 patients received the novel S3U after introduction in our institution. Primary endpoint was PVR after TAVR. Furthermore, we investigated procedural parameters and in-hospital and 30-day outcome. Results: PVR was significantly lower in the S3U cohort compared to the S3 cohort. They differed in their rate of mild PVR (11.2 vs. 48.0%, p < 0.001), whereas at least moderate PVR was similarly low in both cohorts (0.7 vs. 0.5%, p = 0.811). A significant reduction of post-dilatation rate, fluoroscopy time, and amount of contrast was observed in patients treated with the novel S3U (p < 0.001). The rate of adverse events in the in-hospital course and at 30 days were similarly low. At 30 days more patients receiving S3U improved in NYHA class (improvement ≥2 grades 34.6 vs. 19.9%, p = 0.003). Conclusion: The current study provides evidence that the novel S3U strongly minimizes PVR, thereby demonstrating the efficacy of improved sealing. Further studies will have to address if the observed reduction of PVR with S3U has prognostic significance.

Concomitant tricuspid regurgitation severity and its secondary reduction determine long-term prognosis after transcatheter mitral valve edge-to-edge repair.

BACKGROUND: Concomitant tricuspid regurgitation (TR) is a common finding in mitral regurgitation (MR). Transcatheter repair (TMVR) is a favorable treatment option in patients at elevated surgical risk. To date, evidence on long-term prognosis and the prognostic impact of TR after TMVR is limited. METHODS: Long-term survival data of patients undergoing isolated edge-to-edge repair from June 2010 to March 2018 (combinations with other forms of TMVR or tricuspid valve therapy excluded) were analyzed in a retrospective monocentric study. TR severity was categorized and the impact of TR on survival was analysed. RESULTS: Overall, 606 patients [46.5% female, 56.4% functional MR (FMR)] were enrolled in this study. TR at baseline was categorized severe/medium/mild/no or trace in 23.2/34.3/36.3/6.3% of the cases. At 30-day follow-up, improvement of at least one TR-grade was documented in 34.9%. Severe TR at baseline was identified as predictor of 1-year survival [65.2% vs. 77.0%, p = 0.030; HR for death 1.68 (95% CI 1.12-2.54), p = 0.013] and in FMR-patients also regarding long-term prognosis [adjusted HR for long-term mortality 1.57 (95% CI 1.00-2.45), p = 0.049]. Missing post-interventional reduction of TR severity was predictive for poor prognosis, especially in the FMR-subgroup [1-year survival: 92.9% vs. 78.3%, p = 0.025; HR for death at 1-year follow-up 3.31 (95% CI 1.15-9.58), p = 0.027]. While BNP levels decreased in both subgroups, TR reduction was associated with improved symptomatic benefit (NYHA-class-reduction 78.6 vs. 65.9%, p = 0.021). CONCLUSION: In this large study, both, severe TR at baseline as well as missing secondary reduction were predictive for impaired long-term prognosis, especially in patients with FMR etiology. TR reduction was associated with increased symptomatic benefit.

Determination of optimal fluoroscopic angulations for aorto-coronary ostial interventions from coronary computed tomography angiography.

BACKGROUND: An optimal aorto-coronary angiographic projection, characterized by an orthogonal visualization of the proximal coronary artery, is crucial for interventional success. We determined the distribution of optimal C-arm positions and assessed their feasibility by invasive coronary angiography. METHODS: Orthogonal aorto-coronary ostial angulations were determined in 310 CT data sets. In 100 patients undergoing subsequent invasive angiography, we assessed if the CT-predicted angulations were achievable by the C-arm system. If the predicted projection was not achievable due to mechanical constraints of the C-arm system, the most close, achievable angulation was determined. Patient characteristics were analyzed regarding the distribution of optimal angulations and its feasibility by the C-arm system. RESULTS: For the left ostium, CT revealed a mean angulation of LAO 23 â€‹± â€‹21°/cranial 25 â€‹± â€‹23° (90% of patients with a LAO/cranial angulation, 3% LAO/caudal, 4% RAO/cranial, 3% RAO/caudal) and were achievable by the C-arm system in 87% of patients. For the right ostium, the mean CT-predicted orthogonal angulation was LAO 36 â€‹± â€‹37°/cranial 36 â€‹± â€‹51° (84% LAO/cranial, 2% LAO/caudal, 14% RAO/caudal) and achievable by the C-arm system in 45% of patients. For the left ostium, a higher body weight was associated with a steeper LAO/cranial angulation being less feasible by the C-arm system due to mechanical constraints. CONCLUSIONS: Orthogonal aorto-left coronary angulations show a relative narrow distribution predominately in LAO/cranial position whereas a wider range of angulations was found for the right coronary ostium. The feasibility of CT-predicted angulations by the C-arm system is more restricted for the right than the left coronary ostium.

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.

Computed tomography imaging needs for novel transcatheter tricuspid valve repair and replacement therapies.

Transcatheter tricuspid valve therapies are an emerging field in structural heart interventions due to the rising number of patients with severe tricuspid regurgitation and the high risk for surgical treatment. Computed tomography (CT) allows exact measurements of the annular plane, evaluation of adjacent structures, assessment of the access route, and can also be used to identify optimal fluoroscopic projection planes to enhance periprocedural imaging. This review provides an overview of current transcatheter tricuspid valve repair and replacement therapies and to what extent CT can support these interventions.