BACKGROUND:Calcium is a determinant of paravalvular leakage (PVL) after transcatheter aortic valve implantation (TAVI). This is based on a fixed contrast attenuation value while X-ray attenuation is patient-dependent and without considering frame expansion and PVL location. We examined the role of calcium in (site-specific) PVL after TAVI using a patient-specific contrast attenuation coefficient combined with frame expansion.METHODS:57 patients were included with baseline CT, post-TAVI transthoracic echocardiography and rotational angiography (R-angio). Calcium load was assessed using a patient-specific contrast attenuation coefficient. Baseline CT and post-TAVI R-angio were fused to assess frame expansion. PVL was assessed by a core lab.RESULTS:Overall, the highest calcium load was at the non-coronary-cusp-region (NCR, 436 mm3) vs. the right-coronary-cusp-region (RCR, 233 mm3) and the left-coronary-cusp-region (LCR, 244 mm3), p < 0.001. Calcium load was higher in patients with vs. without PVL (1,137 vs. 742 mm3, p = 0.012) and was an independent predictor of PVL (odds ratio, 4.83, p = 0.004). PVL was seen most often in the LCR (39% vs. 21% [RCR] and 19% [NCR]). The degree of frame expansion was 71% at the NCR, 70% at the RCR and 74% at the LCR without difference between patients with or without PVL.CONCLUSIONS:Calcium load was higher in patients with PVL and was an independent predictor of PVL. While calcium was predominantly seen at the NCR, PVL was most often at the LCR. These findings indicate that in addition to calcium, specific anatomic features play a role in PVL after TAVI.

Childhood obesity continues to escalate worldwide and may affect left ventricular (LV) geometry and function. The aim of this study was to investigate the impact of obesity on prevalence of left ventricular hypertrophy (LVH) and diastolic dysfunction in children. In this analysis of prospectively collected cross-sectional data of children between 5 and 16 years of age from randomly selected schools in Peru, parameters of LV geometry and function were compared according to presence or absence of obesity (body mass index z-score > 2). LVH was based on left ventricular mass index (LVMI) adjusted for age and sex and defined by a z-score of > 2. LV diastolic function was assessed using mitral inflow early-to-late diastolic flow (E/A) ratio, peak early diastolic tissue velocities of the lateral mitral annulus (E′), early diastolic transmitral flow velocity to tissue Doppler mitral annular early diastolic velocity (E/E′) ratio, and left atrial volume index (LAVI). Among 1023 children, 681 children (mean age 12.2 ± 3.1 years, 341 male (50.1%)) were available for the present analysis, of which 150 (22.0%) were obese. LVH was found in 21 (14.0%) obese and in 19 (3.6%) non-obese children (p adjusted < 0.001). LVMI was greater in obese than that in non-obese children (36.1 ± 8.6 versus 28.7 ± 6.9 g/m 2.7 , p < 0.001). The mean mitral E/E′ ratio and LAVI were significantly higher in obese than those in non-obese individuals (E/E′: 5.2 ± 1.1 versus 4.9 ± 0.8, p adjusted = 0.043; LAVI 11.0 ± 3.2 versus 9.6 ± 2.9, p adjusted = 0.001), whereas E′ and E/A ratio were comparable. Childhood obesity was associated with left ventricular hypertrophy and determinants of diastolic dysfunction. ClinicalTrials.gov Identifier: NCT02353663.

Background Infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) occurs in up to 1.5% of patients within the first year. The development of an aorto-atrial fistula (AAF) is a rare but problematic complication of IE, which can be confirmed with transoesophageal echocardiography (TOE). We present an exceptional case of occluding an aorto-left atrial fistula only diagnosed with intraprocedural TOE during a subsequent procedure of MitraClip implantation. Case summary A 79-year-old symptomatic male patient with multiple comorbidities was referred due to severe mitral regurgitation (MR). He has had prior TAVI which was complicated with streptococcal IE for which he had received prolonged antibacterial therapy. Transthoracic echocardiography (TTE) revealed severe MR. The patient was accepted for a MitraClip procedure by the heart team. Intra-procedural TOE revealed also a significant continuous shunt through an AAF which was likely caused by the endocarditis. The strategy was therefore defined as to occlude the fistula with an Amplatzer Vascular Plug II 12 mm. The plug was released in the fistula leaving an insignificant residual shunt. After the transseptal puncture one MitraClip XTR was implanted, reducing the MR to mild. After the procedure, the patient’s general clinical condition improved without signs of haemolysis. The pre-discharge TTE confirmed trace residual shunt, mild residual MR and mild paravalvular leakage. Discussion Our case illustrates a complex transcatheter structural heart intervention with improvised procedural strategies based on the intra-procedural TOE findings. We conclude that the pre-procedural TOE needs to be comprehensive rather than exclusive, particularly in the context of bioprosthesis-related endocarditis.

We present the case of a 71-year-old man admitted because of chest tightness, palpitations, and progressive shortness of breath. The diagnosis of severe aortic stenosis, coarctation, and aneurysm was established, as well as severely depressed left ventricular ejection fraction. Three consecutive transcatheter procedures were successfully performed in a single session. (Level of Difficulty: Advanced.).

HomeCirculationVol. 143, No. 9Feasibility and Performance of Noninvasive Ultrasound Therapy in Patients With Severe Symptomatic Aortic Valve Stenosis Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBFeasibility and Performance of Noninvasive Ultrasound Therapy in Patients With Severe Symptomatic Aortic Valve StenosisA First-in-Human Study Emmanuel Messas, MD, PhD, Alexander IJsselmuiden, MD, PhD, Guillaume Goudot, MD, PhD, Selina Vlieger, MSc, Samuel Zarka, MD, Etienne Puymirat, MD, PhD, Bernard Cholley, MD, PhD, Christian Spaulding, MD, PhD, Albert A. Hagège, MD, PhD, Eloi Marijon, MD, PhD, Mickael Tanter, PhD, Benjamin Bertrand, MSF, Mathieu C. Rémond, DSc, Robin Penot, MSc, B. Ren, MD, PhD, Peter den Heijer, MD, PhD, Mathieu Pernot, PhD and René Spaargaren, MD Emmanuel MessasEmmanuel Messas Emmanuel Messas, MD, PhD, Hôpital Européen Georges Pompidou, Université Paris Descartes, Cardio-Vascular Departement, UMR 970, Paris, France. Email E-mail Address: [email protected] https://orcid.org/0000-0003-3214-7501 Cardiovascular Department (E. Messas, G.G., S.Z., E.P., B.C., C.S., A. A.A.H., E. Marijon), APHP Université de Paris, France. French Research Consortium RHU STOP-AS, Rouen, France. (E. Messas, B.B., M.C.R., R.P., R.S.). , Alexander IJsselmuidenAlexander IJsselmuiden Heart Center, Amphia Hospital, Breda, The Netherlands (A.I., S.V., P.d.H.). , Guillaume GoudotGuillaume Goudot Cardiovascular Department (E. Messas, G.G., S.Z., E.P., B.C., C.S., A. A.A.H., E. Marijon), APHP Université de Paris, France. , Selina VliegerSelina Vlieger Heart Center, Amphia Hospital, Breda, The Netherlands (A.I., S.V., P.d.H.). , Samuel ZarkaSamuel Zarka Cardiovascular Department (E. Messas, G.G., S.Z., E.P., B.C., C.S., A. A.A.H., E. Marijon), APHP Université de Paris, France. , Etienne PuymiratEtienne Puymirat Cardiovascular Department (E. Messas, G.G., S.Z., E.P., B.C., C.S., A. A.A.H., E. Marijon), APHP Université de Paris, France. , Bernard CholleyBernard Cholley https://orcid.org/0000-0001-6388-6011 Cardiovascular Department (E. Messas, G.G., S.Z., E.P., B.C., C.S., A. A.A.H., E. Marijon), APHP Université de Paris, France. Anesthesiology and Critical Care Department, Hôpital Européen Georges-Pompidou (B.C.), APHP Université de Paris, France. , Christian SpauldingChristian Spaulding Cardiovascular Department (E. Messas, G.G., S.Z., E.P., B.C., C.S., A. A.A.H., E. Marijon), APHP Université de Paris, France. , Albert A. HagègeAlbert A. Hagège Cardiovascular Department (E. Messas, G.G., S.Z., E.P., B.C., C.S., A. A.A.H., E. Marijon), APHP Université de Paris, France. , Eloi MarijonEloi Marijon Cardiovascular Department (E. Messas, G.G., S.Z., E.P., B.C., C.S., A. A.A.H., E. Marijon), APHP Université de Paris, France. , Mickael TanterMickael Tanter Physics for Medicine, U1273 INSERM, ESPCI Paris, CNRS, PSL Research University, France (M.T., M.P.). , Benjamin BertrandBenjamin Bertrand Cardiawave, Paris, France (B.B., M.C.R., R.P., R.S.). French Research Consortium RHU STOP-AS, Rouen, France. (E. Messas, B.B., M.C.R., R.P., R.S.). , Mathieu C. RémondMathieu C. Rémond Cardiawave, Paris, France (B.B., M.C.R., R.P., R.S.). French Research Consortium RHU STOP-AS, Rouen, France. (E. Messas, B.B., M.C.R., R.P., R.S.). , Robin PenotRobin Penot Cardiawave, Paris, France (B.B., M.C.R., R.P., R.S.). French Research Consortium RHU STOP-AS, Rouen, France. (E. Messas, B.B., M.C.R., R.P., R.S.). , B. RenB. Ren Cardialysis, Rotterdam, The Netherlands (B.R.). , Peter den HeijerPeter den Heijer Heart Center, Amphia Hospital, Breda, The Netherlands (A.I., S.V., P.d.H.). , Mathieu PernotMathieu Pernot Physics for Medicine, U1273 INSERM, ESPCI Paris, CNRS, PSL Research University, France (M.T., M.P.). and René SpaargarenRené Spaargaren Cardiawave, Paris, France (B.B., M.C.R., R.P., R.S.). French Research Consortium RHU STOP-AS, Rouen, France. (E. Messas, B.B., M.C.R., R.P., R.S.). Originally published25 Jan 2021https://doi.org/10.1161/CIRCULATIONAHA.120.050672Circulation. 2021;143:968–970Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 25, 2021: Ahead of Print Calcific aortic stenosis (CAS) is currently the most common heart valve disease. To date, surgical or transcatheter aortic valve replacement is the only effective treatment. However, 16% of patients with symptomatic severe CAS are rejected by local heart teams for surgical or transcatheter aortic valve replacement.1 Valvosoft (Cardiawave) is a device designed to improve the function of calcified aortic valves (AVs) with noninvasive ultrasound therapy (NIUT).2 On the basis of preclinical results,2,3 a prospective first-in-human study was conducted in 2 centers (Hôpital Européen Georges-Pompidou, France; Amphia Hospital, Breda, The Netherlands) in 10 patients with symptomatic severe CAS who were not eligible for AV replacement according to local heart teams (mainly because of comorbidities, vascular access, and life expectancy <12 months; https://www.clinicaltrials.gov, NCT03779620). The study was conducted in accordance with the Declaration of Helsinki and approved by the ethics committees of both participating centers and the competent authorities of The Netherlands and France. All patients provided written informed consent.The mechanism of action of NIUT consists of generating microscopic cavitation bubbles with short, high-pressure ultrasound pulses focused on the AV. As cavitation bubbles collapse, they produce shock waves inducing mechanical softening of the targeted calcified valve leaflet. Therapeutic dose was estimated as the mean acoustic focal energy (J/mm2) that integrates focal intensity over procedure duration.Data were presented as mean±SD for continuous variables and number and percentage for categorical data. Paired-sample t test or independent-sample t test, when appropriate, was used to compare continuous variables. Data will be made available from the corresponding author on reasonable request.Patients (mean age, 84.1±6.5 years; 50% women) had severe CAS (mean AV area, 0.61±0.18 cm2; mean pressure gradient, 37.5±10.5 mm Hg) and presented with severe comorbidities. NIUT could be delivered on the AV transthoracically in all patients using the real-time echo guiding of the device. Mean ultrasound delivery time was 52 minutes (range, 37–60 minutes), and mean acoustic focal energy delivered on the AV was 221±87 J/mm2.Seven patients were treated in a hybrid operating room and 3 in a catheterization laboratory. During the procedure, 1 patient developed atrial fibrillation, which spontaneously converted to sinus rhythm within minutes, and 7 patients had a few premature ventricular beats. Two patients had nonsustained ventricular tachycardia that lasted <4 seconds; this was hemodynamically well tolerated and resolved spontaneously. Events such as arrhythmia and chest wall discomfort from transducer pressure were managed with sedation or analgesia combined with short pauses in ultrasound application. Six patients were treated without general anesthesia, 4 of them without sedation. No deaths, myocardial infarctions, strokes, or transient ischemic attacks were reported at the 1-month follow-up. Patient 2 was hospitalized 2 weeks after the procedure for right-sided heart failure, which resolved and was adjudicated not to be procedure or device related.Clinical and echocardiographic evaluation was performed by an independent core laboratory. No significant difference between baseline and follow-up at 1 month was observed in the Mini-Mental State Examination score, suggesting that the cognitive function was not impaired. New-onset or worsening aortic regurgitation was not detected. No changes in left ventricular function and volumes were observed. For the overall population, a nonsignificant increase in AV area of 16.4% (0.61 cm2 versus 0.71 cm2; P=0.112) and a nonsignificant decrease in mean pressure gradient of 12.5% (37.5 mm Hg versus 32.8 mm Hg; P=0.191) were observed (Figure [A]). Figure (B) shows the wide variability in treatment response. Six patients were responders (patients 2–4 and 8–10) with an increase in AV area of 27.6% (P=0.03), associated with a decrease in mean pressure gradient of 23.5% (P=0.03). The duration of therapy was significantly longer in the responder group than in the nonresponder group (56.8±3.7 minutes versus 44.4±7.0 minutes; P<0.05), and the cumulative focal energy delivery was >180 J/mm2 (Figure [C]). Post hoc exploratory analysis attempting to identify factors potentially associated with treatment response suggests that a minimum treatment duration and focal energy may be needed to obtain a clinical effect.Download figureDownload PowerPointFigure. Treatment characteristics and changes in AVA and mean PG.A, Percent changes in aortic valve area (AVA) and mean pressure gradient (PG) at 1 month with respect to baseline for all patients. B, Change in AVA and mean PG for all patients. Patients were defined as responders if they showed an increase in AVA and a decrease in mean PG with improvement or stabilization of New York Heart Association class at 1 month after the procedure compared with baseline. Responders are represented as blue diamonds (top left); nonresponders are represented as orange circles. C, Responders and nonresponders are plotted as a function of treatment duration and focal energy. All 6 responders received >180 J/mm2 for at least 45 minutes. Of the 4 non-responders, 3 received less focal energy or energy for a duration <45 minutes; 1 nonresponder is on the border of the specified area. NIUT indicates noninvasive ultrasound therapy.NIUT is noninvasive, unlike other devices using similar concepts of calcium fragmentation,4 and can be performed without general anesthesia.Overall, current clinical data show that NIUT was feasible in 10 patients with severe CAS. Ongoing clinical studies are assessing its safety and the effects of higher energy doses. Current results reflect only 1-month outcomes and do not address safety and durability of the therapy. Brain magnetic resonance imaging was not performed in this study; therefore, silent cerebrovascular events5 cannot be ruled out.In conclusion, NIUT was feasible in this small cohort of 10 patients with severe CAS. Patients with the longest therapy time and highest energy levels showed promising results. Further studies with optimized treatment and longer follow-up are required to evaluate the safety, performance, and durability of this new technique and to determine the population benefiting most.Sources of FundingThis study has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement 829492 and is supported by the French Government, managed by the National Research Agency under the "Investissements d'avenir" program (reference Nos. ANR-16-RHUS-0003 and ANR VALVOSOFT-17-CE19-0019-02).Disclosures Drs Messas, M. Pernot, and Tanter are cofounders and shareholders of Cardiawave SA. B. Bertrand is cofounder and CEO of Cardiawave SA. R. Penot, Dr Rémond, and Dr Spaargaren are employees of Cardiawave SA. The other authors report no conflicts.FootnotesRegistration: URL https://www.clinicaltrials.gov; Unique identifier: NCT03779620.https://www.ahajournals.org/journal/circEmmanuel Messas, MD, PhD, Hôpital Européen Georges Pompidou, Université Paris Descartes, Cardio-Vascular Departement, UMR 970, Paris, France. Email emmanuel.[email protected]frReferences1. Durko AP, Osnabrugge RL, Van Mieghem NM, Milojevic M, Mylotte D, Nkomo VT, Pieter Kappetein A. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections.Eur Heart J. 2018; 39:2635–2642. doi: 10.1093/eurheartj/ehy107CrossrefMedlineGoogle Scholar2. Villemain O, Robin J, Bel A, Kwiecinski W, Bruneval P, Arnal B, Ré , mond M, Tanter M, Messas E, Pernot M. Pulsed cavitational ultrasound softening: a new noninvasive therapeutic approach for calcified bioprosthetic valve stenosis.JACC Basic Transl Sci. 2017; 2:372–383.CrossrefMedlineGoogle Scholar3. Messas E, Rémond MC, Goudot G, Zarka S, Penot R, Mateo P, Kwiecinski W, Escudero DS, Bel A, Ialy-Radio N, et al.. Feasibility and safety of non-invasive ultrasound therapy (NIUT) on an porcine aortic valve.Phys Med Biol. 2020; 65:215004. doi: 10.1088/1361-6560/aba6d3CrossrefMedlineGoogle Scholar4. Bartus K, Surve D, Sato Y, Halevi R, Kislev Y, Sax S, Markov L, Golan E, Levy R, Halon D, et al.. The LeaflexTM catheter: a novel device for treating calcific aortic stenosis: first-in-human intra-operative assessment of safety and efficacy.Struct Heart. 2020; 4:221–229. doi: 10.1080/24748706.2020.1746983CrossrefGoogle Scholar5. Nombela-Franco L, Armijo G, Tirado-Conte G. Cerebral embolic protection devices during transcatheter aortic valve implantation: clinical versus silent embolism.J Thorac Dis. 2018; 10(suppl 30):S3604–S3613. doi: 10.21037/jtd.2018.09.62CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Meng Y, Pople C, Budiansky D, Li D, Suppiah S, Lim-Fat M, Perry J, Sahgal A and Lipsman N (2021) Current state of therapeutic focused ultrasound applications in neuro-oncology, Journal of Neuro-Oncology, 10.1007/s11060-021-03861-0, 156:1, (49-59), Online publication date: 1-Jan-2022. Dall'Ara G, Grotti S, Guerrieri G, Compagnone M, Spartà D, Galvani M and Tarantino F (2022) Balloon aortic valvuloplasty: current status and future prospects, Expert Review of Cardiovascular Therapy, 10.1080/14779072.2022.2074837, 20:5, (389-402), Online publication date: 4-May-2022. Todurov B, Markovets A, Maruniak S and Demyanchuk V (2022) ULTRASONIC DECALCIFICATION OF AORTIC VALVE IN MODERN ERA: A CASE REPORT, Wiadomości Lekarskie, 10.36740/WLek202203128, 75:3, (732-734), Online publication date: 1-Mar-2022. Xu Z, Hall T, Vlaisavljevich E and Lee F (2021) Histotripsy: the first noninvasive, non-ionizing, non-thermal ablation technique based on ultrasound, International Journal of Hyperthermia, 10.1080/02656736.2021.1905189, 38:1, (561-575), Online publication date: 1-Jan-2021. Smadja D, Goudot G, Gendron N, Zarka S, Puymirat E, Philippe A, Spaulding C, Peronino C, Tanter M, Pernot M and Messas E (2021) Von Willebrand factor multimers during non-invasive ultrasound therapy for aortic valve stenosis, Angiogenesis, 10.1007/s10456-021-09803-8, 24:4, (715-717), Online publication date: 1-Nov-2021. Messas E and Goudot G (2021) La révolution des ultrasons en cardiologie et en pathologies vasculaires adultes : une épopée de plus de cinquante ans du diagnostic à la thérapie non invasive, Archives des Maladies du Coeur et des Vaisseaux - Pratique, 10.1016/j.amcp.2021.06.009, 2021:300, (28-30), Online publication date: 1-Sep-2021. March 2, 2021Vol 143, Issue 9 Advertisement Article InformationMetrics © 2021 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.120.050672PMID: 33486971 Originally publishedJanuary 25, 2021 KeywordsultrasonicsaortavalvescalciumPDF download Advertisement SubjectsClinical StudiesTreatment

The coronavirus disease 2019 (COVID-19) pandemic started in Wuhan, Hubei Province, China, in December 2019, and by 24 April 2020, it had affected >2.73 million people in 185 countries and caused >192,000 deaths. Despite diverse societal measures to reduce transmission of the severe acute respiratory syndrome coronavirus 2, such as implementing social distancing, quarantine, curfews and total lockdowns, its control remains challenging. Healthcare practitioners are at the frontline of defence against the virus, with increasing institutional and governmental supports. Nevertheless, new or ongoing clinical trials, not related to the disease itself, remain important for the development of new therapies, and require interactions among patients, clinicians and research personnel, which is challenging, given isolation measures. In this article, the authors summarise the acute effects and consequences of the COVID-19 pandemic on current cardiovascular trials.

Objectives: A retrospective observational cohort study to report on contemporary indications of balloon aortic valvuloplasty (BAV). Background: As indications for transcatheter aortic valve replacement (TAVR) are increasing, BAV is reinforced as a bridging therapy. Methods: A total of 47 consecutive patients who underwent BAV in parallel to an existing TAVR program was retrospectively assessed for BAV indications and clinical events during 1 year of follow-up. Results: The following indications were distinguished: bridge to destination aortic valve replacement therapy (BTD), bridge to urgent non-cardiac therapy (BTN) or palliation. BAV was performed in 20 (43%) patients as BTD, in 18 (38%) as BTN and in 9 (19%) as palliative treatment. Patients in the BTN cohort were younger (age 74.1 +/- 8.3% vs. 80.7 +/- 8.3% years in BTD, p = 0.02) with lower STS-scores (2.2% [IQR 1.3-4.6] vs. 13.0% [IQR 7.6-22.2] p < 0.001). Overall baseline mean transaortic gradient was 43.2 mmHg and reduced by a mean of 16.0 +/- 10.1 mmHg after BAV (p < 0.001). Procedural mortality was 8.5% (n = 4). All-cause mortality at 30 days and 1 year was 20% and 45% in BTD, 6% and 39% in BTN and 44% and 67% in the palliative group. Aortic valve replacement (AVR) was performed in 55% of the BTD and 50% of the BTN group at 1 year. Reasons for not undergoing definite AVR were clinical deterioration in BTD and terminal comorbidity in BTN. Compared to a contemporary TAVR cohort, procedural and 1 year mortality was significantly increased in the BAV cohort. Conclusion: BAV remains a valuable option in well-defined patient phenotypes to determine AVR feasibility, bridge to urgent non-cardiac therapy, and at times, palliation. These phenotypes represent vulnerable patients with overall poor clinical outcome.

Background: Elevated pulmonary artery pressure (PAP) in patients with severe aortic stenosis (AS) is a strong predictor of adverse prognosis. This study sought to assess the relation between PAP and clinical and echocardiographic parameters in elderly patients with severe AS, as well as to identify the determinants of the change in PAP after transcatheter aortic valve implantation (TAVI). Methods: The study included 170 subjects (age 81 ± 7 years, 45% men) with symptomatic severe AS who were treated by TAVI. They underwent a clinical evaluation and a transthoracic echocardiography before the TAVI procedure and 6 months after. Results: In a multivariable analysis, the independent predictors for baseline PAP were the body mass index (BMI) (β = 0.21, p =.006), COPD GOLD class (β = 0.20; p =.009), the E/e′ ratio (β = 0.20; p =.02) and the degree of aortic regurgitation (β = 0.20; p =.01). After TAVI, there was significantly less (51% vs. 29%, p<.0001) pulmonary hypertension, defined as a tricuspid regurgitation velocity ≥2.8 m/s. The baseline variables related to an improvement in PAP were the tricuspid regurgitation velocity (p =.0001) and the E/e′ (p =.005). From the parameters potentially modified with TAVI, the only independent predictor of PAP variation was the change in the E/e′ ratio (β = 0.23; p =.01). Conclusions: Independent predictors for baseline PAP in elderly patients with symptomatic AS were the BMI, GOLD class, the aortic regurgitation and the E/e′ ratio. The baseline predictors for a change in PAP 6 months after TAVI were the baseline PAP and E/e′, with only the change in the E/e′ ratio being correlated to the change in PAP.

Background: Elevated pulmonary artery pressure (PAP) in patients with severe aortic stenosis (AS) is a strong predictor of adverse prognosis. This study sought to assess the relation between PAP and clinical and echocardiographic parameters in elderly patients with severe AS, as well as to identify the determinants of the change in PAP after transcatheter aortic valve implantation (TAVI). Methods: The study included 170 subjects (age 81 +/- 7 years, 45% men) with symptomatic severe AS who were treated by TAVI. They underwent a clinical evaluation and a transthoracic echocardiography before the TAVI procedure and 6 months after. Results: In a multivariable analysis, the independent predictors for baseline PAP were the body mass index (BMI) (beta = 0.21, p = .006), COPD GOLD class (beta = 0.20; p = .009), the E/e ' ratio (beta = 0.20; p = .02) and the degree of aortic regurgitation (beta = 0.20; p = .01). After TAVI, there was significantly less (51% vs. 29%, p<.0001) pulmonary hypertension, defined as a tricuspid regurgitation velocity >= 2.8 m/s. The baseline variables related to an improvement in PAP were the tricuspid regurgitation velocity (p = .0001) and the E/e ' (p = .005). From the parameters potentially modified with TAVI, the only independent predictor of PAP variation was the change in the E/e ' ratio (beta = 0.23; p = .01). Conclusions: Independent predictors for baseline PAP in elderly patients with symptomatic AS were the BMI, GOLD class, the aortic regurgitation and the E/e ' ratio. The baseline predictors for a change in PAP 6 months after TAVI were the baseline PAP and E/e ', with only the change in the E/e ' ratio being correlated to the change in PAP.

OBJECTIVES The aim of this study was to assess the added value and predictive power of the TAVIguide (Added Value of Patient-Specific Computer Simulation in Transcatheter Aortic Valve Implantation) software in clinical practice. BACKGROUND Optimal outcome after transcatheter aortic valve replacement (TAVR) may become more important as TAVR shifts toward low-risk patients. Patient-specific computer simulation is able to provide prediction of outcome after TAVR. Its clinical role and validation of accuracy, however, have not yet been studied prospectively. METHODS A prospective, observational, multicenter study was conducted among 80 patients with severe aortic stenosis treated with the Evolut R valve. Simulation was performed in 42 patients and no simulation in 38. A comparison between the valve size (decision 1) and target depth of implantation selected by the operator on the basis of multislice computed tomography and the valve size (decision 2) and target depth of implantation selected after simulation were the primary endpoints. Predictive power was examined by comparing the simulated and observed degree of aortic regurgitation. RESULTS Decision 2 differed from decision 1 in 1 of 42 patients because of predicted paravalvular leakage, and changes in valve type occurred in 2 of 42. In 39 of 42 patients, decisions 1 and 2 were similar. Target depth of implantation differed in 7 of 42 patients after simulation (lower in 4 and higher in 3). In 16 of 42 patients, simulation affected the TAVR procedure; in 9, the operator avoided additional measures to achieve the target depth of implantation, and in 7 patients, additional measures were performed. There was a trend toward a higher degree of predicted than observed aortic regurgitation (17.5 vs. 12 ml/s; p = 0.13). CONCLUSIONS Patient-specific computer simulation did not affect valve size selection but did affect the selection of the target depth of implantation and the execution of TAVR to achieve the desired target depth of implantation. (c) 2020 by the American College of Cardiology Foundation.

Abstract Aims Significant mitral regurgitation (MR) is an important predictor for all‐cause mortality and heart failure (HF) hospitalizations independent of left ventricular ejection fraction (LVEF). The aims of this study were to investigate (i) in how many patients referred to a tertiary outpatient HF clinic HF therapy could be optimized, (ii) the effect of optimized treatment on MR severity, and (iii) whether a reduction in MR resulted in improvement of symptoms. Methods and results Forty‐seven referred patients with therapy‐resistant symptomatic chronic HF with an LVEF <40% and at least moderate MR were analysed on admission and after optimization of HF treatment after 6–18 months. The patients were classified as a volume responder when LV end‐systolic volume (LVESV) decreased ≥15%, as LVEF responder when LVEF increased by ≥5% points, as clinical responder when New York Heart Association (NYHA) class improved at least one category, and as MR responder when MR severity improved at least one category to maximally moderate. After 14 ± 4 months of treatment optimization, optimal doses of angiotensin‐converting enzyme inhibitors/angiotensin receptor blocker were seen in 18 (38%) patients compared with three (6%) at baseline (P < 0.001), and optimal doses of beta‐blockers were seen in 14 (30%) patients compared with four (9%) at baseline (P < 0.001). In total, 68% of the patients were clinical responders, 57% MR responders, 34% volumetric responders, and 49% LVEF responders. NYHA class improved from 2.9 ± 0.6 to 2.0 ± 0.9 (P < 0.001), MR class from 5.2 ± 0.8 to 3.6 ± 1.5 (P < 0.001), LVEF from 24% ± 9% to 31% ± 12% (P < 0.01), and LVESV non‐significantly improved. The positive predictive value of MR response to NYHA response was 88%; the negative predictive value was 53%, agreement 69%, and kappa 0.39. The positive predictive value of LVEF response to NYHA response was 76%; the negative predictive value was 44%, agreement 60%, and kappa 0.21. The positive predictive value of LVESV volume response to NYHA response was 75%; the negative predictive value was 39%, agreement 51%, and kappa 0.12. Conclusions Although this study was limited by a small number of patients, initiation and up‐titration of recommended HF therapy in patients referred to our tertiary HF outpatient clinic resulted in significant MR reduction in over half of the patients, emphasizing the importance of optimal medical treatment in these very sick cardiac patients with otherwise grave prognosis. MR reduction was best correlated to NYHA improvement.

Introduction Balloon aortic valvuloplasty (BAV) was originally devised as an alternative approach for treating aortic valve stenosis (AS) in patients who could not undergo aortic valve replacement (AVR)1. However, BAV only provided temporary clinical and haemodynamic improvement and its use was therefore limited to palliative therapy2. Transcatheter aortic valve implantation (TAVI) has revolutionised the treatment of symptomatic severe AS in elderly patients with an elevated operative risk3. Treating this increasingly frail population has renewed interest in a therapy which could temporarily alleviate symptoms in order to bridge patients to definitive valve replacement therapy or other urgent therapy. ...

In this report, we provide an overview of a new, updated echocardiographic classification of mitral regurgitation mechanisms to provide a more comprehensive and detailed assessment of mitral valve disorders. This is relevant to modern mitral valve repair techniques, with special attention to the added value of 3D-echocardiography.

AIMS:We sought to evaluate the interaction of different aortic root phenotypes with self-expanding (SEV), balloon-expandable (BEV) and mechanically expanded (MEV) and the impact on significant aortic regurgitation. METHODS AND RESULTS:We included 392 patients with a SEV (N = 205), BEV (N = 107) or MEV (N = 80). Aortic annulus eccentricity index and calcification were measured by multi-slice CT scan. Paravalvular aortic regurgitation was assessed by contrast aortography (primary analysis) and transthoracic echocardiography (secondary analysis). In mildly calcified roots paravalvular regurgitation incidence was similar for all transcatheter heart valves (SEV 8.4%; BEV 9.1%; MEV 2.0% p = 0.27). Conversely, in heavily calcified roots paravalvular regurgitation incidence was significantly higher with SEV (SEV 45.9%; BEV 0.0%; MEV 0.0% p < 0.001). When paravalvular regurgitation was assessed by TTE, the overall findings were similar although elliptic aortic roots were associated with more paravalvular regurgitation with SEV (20.5% vs. BEV 4.5% vs. MEV 3.2%; p = 0.009). CONCLUSIONS:In heavily calcified aortic roots, significant paravalvular aortic regurgitation is more frequent with SEV than with BEV or MEV, but similar in mildly calcified ones. These findings may support patient-tailored transcatheter heart valve selection. CLASSIFICATIONS:Aortic stenosis; multislice computed tomography; transcatheter aortic valve replacement; paravalvular aortic regurgitation. CONDENSED ABSTRACT:We sought to evaluate the interaction of different aortic root phenotypes with self-expanding (SEV), balloon-expandable (BEV) and mechanically expanded (MEV) and the impact on significant aortic regurgitation. We included 392 patients with a SEV (N = 205), BEV (N = 107) or MEV (N = 80). Aortic annulus eccentricity index and calcification were measured by multi-slice CT scan. Paravalvular aortic regurgitation was assessed by contrast aortography and transthoracic echocardiography. We found that in heavily calcified aortic roots, significant paravalvular aortic regurgitation is more frequent with SEV than with BEV or MEV, but similar in mildly calcified ones.

Moderate aortic stenosis (AS) and reduced left ventricular ejection fraction (LVEF) constitute a clinical entity that has been proposed as a therapeutic target for transcatheter aortic valve replacement (TAVR). It is defined by a mean trans-aortic gradient between 20 and 40 mmHg and an aortic valve area between 1.0 and 1.5 cm2 in patients with LVEF < 50%. Retrospective data suggests a prevalence of 0.8% among patients referred for echocardiographic assessment. These patients are younger and show a higher frequency of previous myocardial infarction than those with severe AS randomized to TAVR in recent trials. In two retrospective studies including patients with moderate AS and reduced LVEF, a one-year mortality rate of 9% and 32% was reported, the latter in patients treated with medical therapy only during follow-up. Echocardiographic diagnosis of moderate AS poses challenges as current guidelines are directed to determine severe AS, and different presentations of moderate and mild AS have been generally neglected. Thus, the nomenclature would need to be revised and a description of possible scenarios is provided in this review. Dobutamine stress echocardiography and computed tomography are promising complementary tools. Likewise, a standardized clinical pathway is needed, in which a high level of suspicion and a low threshold for referral to a heart valve center is warranted. The Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with Advanced heart failure (TAVR UNLOAD) trial (NCT02661451) is exploring whether TAVR would improve outcomes in patients receiving optimal heart failure therapy.

Excellent outcome after transcatheter aortic valve replacement (TAVR) is demonstrated by preserved transcatheter heart valve (THV) function at 2 to 5 years and intact structural integrity at 2 years [(1,2)][1]. Hypoattenuated leaflet thickening (HALT) appears in up to 40% by multislice computed

Patients in coronary intervention trials may require more than 1 procedure to complete the intended revascularization strategy. However, these staged interventions are not consistently defined. Standardized definitions are needed to allow meaningful comparisons of this outcome among trials. This document provides guidance on relevant parameters involving staged procedures, including minimum data collection and consistent classification of coronary procedures initially identified as staged; the aim is to achieve consistency among clinical trialists, sponsors, health authorities, and regulators. Definitions were developed jointly among representatives of academic institutions and clinical research organizations based on clinical trial experience and published literature. Reasons for staged procedures were identified and include baseline kidney function, contrast load and radiation exposure, lesion complexity, and patient or operator fatigue. Moreover, nonclinical reasons include procedure scheduling and reimbursement. Management of staged procedures should be a standalone section in clinical trial protocols and clinical events committee charters. These documents should clearly define a time window for staged procedures that allows latitude for local policies, while respecting accepted clinical guidelines, and consistency with study objectives. Investigators should document in the case report form the intent to stage a procedure, the lesions to be treated, and the reasons for staging, preferably before randomization. Ideally, all reinterventions, or at least all procedures performed after the recommended time window, those in which data suggest an anticipated procedure due to a worsening condition and those where a revascularization is attempted in the target vessel, should be reviewed by an independent clinical events committee.

Background: Right ventricular (RV) systolic dysfunction is associated with worse survival in patients undergoing surgical aortic valve replacement (SAVR), yet it is not included in traditional risk scores of transcatheter aortic valve implantation (TAVI) candidates. We aimed to evaluate the prognostic value of RV systolic function on clinical outcomes in patients undergoing TAVI at one year follow-up; and, echocardiographic changes of RV systolic function up to 12 months after TAVI and compared with SAVR when possible. Methods and results: This systematic review and meta-analysis is registered in PROSPERO (CRD42017065761). Studies investigating RV systolic function with echocardiography in TAVI cohorts were identified from Medline, Embase and Cochrane databases. We used random-effects models to assess differences in primary outcomes. Twenty-one studies were identified, where RV systolic function and clinical outcomes were assessed in eight (4016 patients) and RV systolic function changes were evaluated in 14 (1709 patients). For the primary outcome of all-cause death at one year, RV systolic dysfunction was associated with a significant 78% relative risk increase (risk ratio[95% confidence interval (CI)])= 1.78[1.37, 2.31], P < 0.01), albeit significant heterogeneity (I-2 = 64%, P < 0.01). RV systolic function was unchanged after TAVI throughout follow-up as shown with tricuspid annular plane systolic excursion (TAPSE)(mean difference[95% CI] pre-discharge = 0.03 [-0.92,0.99] mm, 1-3 months = -0.09[-0.89,0.71] mm, 6-12 months = 0.52 [-0.29,1.32] mm, all P = NS), while TAPSE was significantly reduced after SAVR (pre-discharge = -10.17[-13.11,-7.24] mm, P < 0.01; 1-3 months = -7.3[-8.17,-6.44] mm, P < 0.01; 6-12 months = -5.99[-7.95,-4.03] mm, P < 0.01). Conclusions: RV systolic dysfunction was associated with a significant increase in all-cause mortality at one year after TAVI. RV systolic function was unchanged after TAVI up to 12 months, whereas deteriorated significantly after SAVR. (C) 2018 Elsevier B.V. All rights reserved.