Larger Annulus Research Articles

Transcatheter aortic valve replacement with balloon-expandable and self-expandable valves in Japanese patients with large annulus: the OCEAN-TAVI registry

Abstract Background East Asians have smaller aortic valve complexes than individuals from Western countries, and few studies have reported transcatheter aortic valve replacement (TAVR) outcomes in Asian patients with a large annulus. Purpose We aimed to compare the acute and long-term outcomes of TAVR using balloon-expandable valves (BEVs) and self-expandable valves (SEVs) in Asian patients with a large annulus. Methods We retrospectively analyzed the data from the Optimized transCathEter vAlvular interveNtion Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry. A large annulus was defined by annular area ≥ 500 mm2 and average diameter ≥ 25 mm in computed tomography scans. The primary endpoint was the 3-year all-cause mortality. Secondary endpoints were 3-year heart-failure rehospitalization (HFR) after TAVR, acute outcomes of TAVR, and changes in valve function on echocardiography 2 years after TAVR. Results Among 773 patients, 671 (86.8%) underwent BEV-TAVR. The SEV-TAVR group showed a significantly higher incidence of above-moderate perivalvular leakage (2.1% vs. 7.8%; P < 0.001), and included a significantly greater percentage of patients who required postoperative pacemaker implantation (6.1% vs. 11.8%; P = 0.035). The incidence of moderate-to-severe prosthesis–patient mismatch did not differ between the two groups. The Kaplan–Meier curve showed no significant intergroup differences in the 3-year all-cause mortality and HFR rates (log-rank P = 0.900), and the echocardiography-indexed effective orifice area and mean transaortic valve pressure gradient at 2 years post-TAVR did not differ significantly between the two groups. Conclusions The benefits of BEV-TAVR may outweigh those of SEV-TAVR in patients with a large annulus.

Transapical Transcatheter Aortic Valve Replacement Under 3-Dimensional Guidance to Treat Pure Aortic Regurgitation in Patients with a Large Aortic Annulus.

Transcatheter aortic valve replacement (TAVR) is a challenge for patients with aortic regurgitation (AR) and a large annulus. Our goal was to evaluate the clinical outcomes and predictors of transapical TAVR in AR patients with a large annulus and noncalcification and the feasibility and safety of 3-dimensional printing (3DP) in the preprocedural simulation. Patients with a large annulus (diameter >29 mm) were enrolled and divided into the simulation (n = 43) and the nonsimulation group (n = 82). Surgeons used the specific 3DP model of the simulation group to simulate the main steps before the procedure and to refit the transcatheter heart valve (THV) according to the simulated results. The average annular diameter of the overall cohort was 29.8 ± 0.7 mm. Compared with the nonsimulation group, the simulation group used a higher proportion of extra oversizing for THVs (97.6% vs. 85.4%, p = 0.013), and the coaxiality performance was better (9.7 ± 3.9° vs. 12.7 ± 3.8°, p < 0.001). Both THV displacement and ≥ mild paravalvular leakage (PVL) occurred only in the nonsimulation group (9.8% vs. 0, p < 0.001; 9.8% vs. 0, p < 0.001). Multivariate regression analysis showed that extra oversizing, coaxial angle and annulus diameter were independent predictors of THV displacement and ≥ mild PVL, respectively. Based on 3DP guidance, transapical TAVR using extra oversizing was safe and feasible for patients with noncalcified AR with a large annulus. Extra oversizing and coaxial angle were predictors of postprocedural THV displacement and ≥ mild PVL in such patients.

Transcatheter Aortic Valve Implantation in Japanese Patients With Large Annulus: The OCEAN-TAVI Registry

BackgroundEast Asians have smaller aortic valve complexes than individuals from Western countries, and few studies have reported transcatheter aortic valve implantation (TAVI) outcomes in Asian patients with a large annulus. ObjectivesThis study aimed to compare the short- and long-term outcomes of TAVI using balloon-expandable valves (BEVs) and self-expandable valves (SEVs) in Asian patients with a large annulus. MethodsThe study retrospectively analyzed the data from the OCEAN-TAVI (Optimized Transcatheter Valvular Intervention Transcatheter Aortic Valve Implantation) registry. A large annulus was defined by an annular area ≥500 mm2 and an average diameter ≥25 mm as measured by computed tomography. The primary endpoint was 3-year all-cause mortality. Secondary endpoints were 3-year heart failure rehospitalization (HFR) after TAVI, short-term outcomes of TAVI, and changes in valve function 2 years after TAVI. ResultsAmong 773 patients, 671 underwent BEV TAVI. The SEV TAVI group showed a significantly higher incidence of greater than moderate paravalvular leakage (PVL) (P < 0.001), and an increased pacemaker implantation rate (P = 0.035). The incidence of prosthesis-patient mismatch did not differ between the 2 groups. The Kaplan-Meier curve showed no significant differences in 3-year all-cause mortality and HFR rates (log-rank P = 0.900), and echocardiographic valve function at 2 years post-TAVI did not differ between the 2 groups. ConclusionsThe lack of differences in postoperative valve performance and long-term prognosis between BEV TAVI and SEV TAVI highlights the importance of selecting valves that can reduce the pacemaker implantation rate and PVL grade in the acute phase in patients with a large annulus. (Optimized Transcatheter Valvular Intervention Transcatheter Aortic Valve Implantation [OCEAN-TAVI]; UMIN000020423)

Experimental research on the transformation of gas-oil two-phase flow pattern in large vertical annulus

Criteria for gas-oil two-phase flow transformation are essential guidelines that are used as auxiliary equations for the calculation of two-phase flows in gas-oil based drilling fluids within wellbores. The currently used flow pattern transformation criteria, which are based on gas-water two-phase flow experiments in circular pipes or small annuli, have limited applicability when calculating the gas-liquid two-phase flows in oil-based drilling fluids. In this study, experiments were carried out on the transformation of gas-oil two-phase flow patterns in a large annulus (φ100 mm × φ60 mm × 12 m) under different viscosities (16–39 mPa s). The flow characteristics of gas-liquid two-phase flows were measured using electrical capacitance volume tomography (ECVT) at different superficial gas-liquid velocities. It was found that as the liquid phase viscosity increased, the slug flow area gradually expanded, and the superficial gas velocity at which the annular mist flow appeared decreased. When the superficial Reynolds number of the liquid phase exceeded the critical value (approximately 135), the slug flow no longer appeared in the wellbore, and the bubble flow was directly transformed into the churn flow. Based on the results of the dimensionless analysis in the experiments, the criteria for flow-type transitions among different flow patterns were established by considering the influence of the liquid-phase viscosity. Both the average relative errors between the predicted and experimental values of the superficial gas velocity during the bubble-slug, bubble-churn, slug-churn, and churn-annular transitions, at the same superficial liquid velocities, were less than 3.5, 4.5, 3, and 7%, respectively.

FIRST ITALIAN CASE OF TRANSCATHETER TREATMENT OF AORTIC REGURGITATION IN L–VAD PATIENT WITH A DEDICATED DEVICE

Abstract In patients with L–VADs, aortic valve regurgitation is a relatively frequent complication often associated with high mortality. Surgical approaches are extremely complex and often lead to poor outcomes. TAVI can be a feasible solution but it is usually extremely challenging due to the absence of calcification and stenosis. We report the case of a 56–year–old man who underwent LVAD implantation 4years ago as destination therapy for dilated myocardiopathy and chronic multiple myeloma. During the last year, he progressively developed severe pure aortic regurgitation. Last month, he was admitted to our center for heart failure symptoms and recurrent ventricular arrhythmias (VT/VF). The patient was considered at high risk for surgery and evaluated for a transcatheter approach. Due to the absence of calcification and a relatively large annulus, we decided to use the JenaValve Trilogy prosthesis, the only THV CE approved for aortic regurgitation treatment. Unlike other types of THV (self– or balloon expandable), this is specifically designed for AR and does not require significant oversizing to allow correct anchoring. Another advantage in this setting is the possibility of avoiding the reduction of the LVAD flow due to the reduced risk of embolization and the possibility of proceeding to direct implantation without ventricular rapid pacing thanks to the direct anchoring method onto the native aortic leaflets. In this patient, a JenaValve size L bioprosthesis was implanted transfemorally under general anesthesia with an excellent result. The post–operative echocardiography showed a perfectly implanted prosthesis with no intraprosthesis regurgitation and only a mild anterior paravalvular leak with a subsequent improvement of all hemodynamic parameters. In our opinion, when feasible, the JenaValve implant can be a safe and effective therapeutic option in patients with active LVAD devices at high operative risk.

Foamed Cement Mitigates Gas Migration in Shallow Thermal Wells in Alberta

_ This article, written by JPT Technology Editor Chris Carpenter, contains highlights of paper SPE 214768, “Mitigating Gas Migration Using Foamed Cement on Shallow Thermal Wells in Northeast Alberta,” by Charles Sylvestre, SPE, Sanjel Energy Services; Julio Oliveira, Suncor Energy; and Heyong Jiao, Sanjel Energy Services. The paper has not been peer reviewed. _ A foamed cement solution was designed and implemented to cement shallow intermediate casing strings in a heavy oil play in northeast Alberta after conventional area-specific cementing solutions could not prevent surface casing vent flows. Foamed cement was pursued as a better alternative technical solution and ultimately led to its successful placement in the field. Significant technical and operational hurdles were overcome to confirm proper well control and ensure that the energized cement could be pumped safely and effectively. Introduction MacKay River is Alberta’s shallowest steam-assisted gravity drainage (SAGD) project, with wells typically ranging between 100 m and 150 m true vertical depth (TVD). Wells have been drilled recently at MacKay River with a horizontal length approaching 1000 m and total length exceeding 1500 m measured depth (MD). Wells at MacKay River are drilled using a slant rig because of the extremely shallow depth of the reservoir. The wells feature a three-string casing design with a shallow surface casing, an intermediate casing that runs from surface to the target formation and is landed at 90° inclination, and a horizontal production (or injection) liner hung off the intermediate casing. The intermediate casing is cemented in place and uses premium connections incorporating a metal-to-metal seal to provide a barrier between wellbore fluids and the formations overlying the reservoir. The complete paper discusses a new pad at the MacKay River SAGD operating site. The specific operations discussed are those involving intermediate cementing. Case-Well Challenges One of the most unusual features of the case wells was the discovery of gas trapped under a shallow formation at approximately 80–100 m vertical depth. The pad adjacent to this new pad has been in operation for 17 years. The second obstacle was the hole and casing size, which creates a large annulus. The open hole size was designed at 374.7 mm with the intermediate casing sized at 298.5 mm. This creates an annular gap of 38.1 mm in a gauge hole, but typically these wells require 150% cement excess to achieve cement returns to surface, meaning that, in certain areas of the well, the annulus is much larger. The next challenge presented by the case wells is that they are slanted wells, spudded at an angle of approximately 45° from the surface. The low temperature of these wells also adds to the complexity of preventing gas flow. At such low temperatures, cement sets much slower than in other well types. Finally, the shallow nature of the well, landing at only 113 m vertical depth, does not allow effective hydrostatic pressure control while the cement sets.

Etiologies and Impact of Exclusion Rates for Transcatheter Mitral and Tricuspid Valve Structural Heart Clinical Trials at a High-Volume Quaternary Care Hospital

There are various devices under clinical investigation for transcatheter mitral valve intervention (TMVI) and tricuspid valve intervention (TTVI), but exclusion rates remain high. We aim to investigate exclusion rates for transcatheter mitral valve repair (TMVr), transcatheter mitral valve replacement (TMVR), transcatheter tricuspid valve repair (TTVr) and transcatheter tricuspid valve replacement (TTVR). There were a total of 129 patients who were referred to St. Francis Hospital & Heart Center valve clinic and completed screening between January 2021 and July 2022. Causes for exclusion were classified into 4 categories: patient withdrawal, anatomic unsuitability, clinical criteria and medical futility. Among 129 patients, the exclusion rates for TMVr, TMVR, TTVr and TTVR were 81%, 85%, 91% and 87%, respectively. Patient withdrawal and medical futility were leading etiologies for exclusion, followed by anatomical unsuitability. TMVr had the highest rate of patient withdrawal (64%), the lowest anatomic unsuitability (5%) due to short posterior leaflet length. Replacement interventions have higher anatomic unsuitability (33%) compared to repair interventions (17%) (p=0.04). Most exclusions of anatomic unsuitability was due to mitral stenosis or small annulus size for TMVR and large annulus size for TTVR. Fifty percent of exclusions from TTVr were due to presence of pacemaker/defibrillator leads. Among patients excluded from their respective trials, patients being referred for TMVr had the highest recurrent hospitalization and repair group had a higher mortality (p<0.01 and p=0.01, respectively). In conclusion, exclusion rates for TMVI and TTVI trials remain high due to various reasons, limiting patients’ enrollment and treatment. This supports the need for further device improvement or exploring alternative means of therapy.

ON THE ITERATIONS AND THE ARGUMENT DISTRIBUTION OF MEROMORPHIC FUNCTIONS

AbstractThis paper consists of two parts. The first is to study the existence of a point a at the intersection of the Julia set and the escaping set such that a goes to infinity under iterates along Julia directions or Borel directions. Additionally, we find such points that approximate all Borel directions to escape if the meromorphic functions have positive lower order. We confirm the existence of such slowly escaping points under a weaker growth condition. The second is to study the connection between the Fatou set and argument distribution. In view of the filling disks, we show nonexistence of multiply connected Fatou components if an entire function satisfies a weaker growth condition. We prove that the absence of singular directions implies the nonexistence of large annuli in the Fatou set.

Mitigation of gas entrainment in swirling free surface flows

Gas entrainment presents a safety challenge within sodium-cooled fast reactors. This problem is similar to two-phase free surface interactions in a Taylor–Couette flow characterized by a large annulus gap (small radius ratio, η≈0.333) and highly turbulent swirling flows (Re≈105). The aim of the current work is to test strategies that could mitigate this phenomenon. A three-dimensional numerical model of the primary sodium pump annulus region involved in gas entrainment due to shaft rotation was developed, and turbulent swirling flow that occurs in the annular gap between the vessel and the shaft is investigated. The influence of baffle plates mounted on the stationary vessel with and without porosity was examined during the study. The simulation results revealed that submerged porous plates placed on the outer cylindrical wall both delayed vortex breakdown and suppressed shear waves near the surface. Both these effects substantially delayed gas entrainment into the liquid.

Experimental Study on Friction Coefficient of Gas–Oil Two-Phase Flow in a Large Annulus

Summary The friction coefficient is an important factor that affects the accurate calculation of wellbore annular pressure distribution and is of great significance for the safety of drilling operations. To date, investigations of the friction coefficient mainly focused on low-viscosity liquids (such as water and kerosene). Thus, the obtained friction coefficients have poor applicability in the calculation of gas–oil-based mud two-phase flow. This study reports gas–oil two-phase flow experiments for different viscosities (16–39 mPa·s) in the annulus of a large wellbore, performed using an experimental wellbore (Φ100×Φ60×12 000 mm). The gas–liquid mixture Reynolds number ranges from 500 to 10,000. The results reveal a consistent trend for the variation of the friction coefficient under different flow patterns. For the same mixture Reynolds number, a larger liquid viscosity corresponds to a smaller variation of the friction coefficient among different flow patterns. The larger the superficial liquid velocity, the greater the friction coefficient. Based on the dimensionless analysis of the experimental data, a model for the calculation of the friction coefficient of gas–oil two-phase flow in a large annulus is established, and its prediction error relative to the experimental data is found to be less than 30%. This study can provide a basis for accurate calculations of gas–oil-based mud two-phase flow in drilling wellbores.

Intrafraction Dosimetric Evaluation of Biology-Guided Radiotherapy to a Target Under Respiratory Motion

To evaluate the reproducibility and variability of biology-guided radiotherapy (BgRT) treatments using a large anthropomorphic phantom modeling the motion amplitude of a lung tumor. RefleXion X1 is equipped with two opposing 90 degrees PET detector arcs to capture the radionuclide emissions and direct the 6MV Linac to treat the lesions in real time. A custom-built phantom filled with a liquid [¹⁸F]Fluorodeoxyglucose (FDG) solution was used. Fillable target and OAR structures were 3D printed and attached to motion stages. The GTV = CTV was matched to the spherical 22 mm diameter target, and the PTV was a 5 mm expansion from the CTV volume. The Biology Tracking Zone (BTZ) was generated after adding 5 mm margin to the motion extent of the CTV. The OAR was a large C-shape annulus (emulating a heart) that was approximately 3 cm from the target. The 3D independent motion trajectory of the target was designed to mimic lung motion: range of +5.8 mm to -4.9 mm in LR, range of +14.4 mm to -11.3 mm in SI, and range of +5.2 mm to -5.1 mm in AP directions. The OAR motion waveform used a 1D sinusoidal pattern with a 5 mm amplitude in SI direction. The target and the OAR were filled with 40 kBq/mL while the background had 5 kBq/mL FDG. A BgRT Modeling (imaging-only) PET acquisition was performed using RefleXion X1 and used to generate a 4-fraction BgRT treatment plan prescribing 10 Gy/fraction to PTV. For each delivery, target, OAR and background were filled with the same FDG concentrations as in the BgRT Modeling PET planning scan. Dosimetry to the target and OAR were both measured using an ion-chamber (Exradin A14SL) and film in the coronal plane through the center of the GTV for all 4 fractions. The mean activity concentration within the (BTZ) was 7.4 ± 0.8 kBq/mL. The calculated signal-to-noise ratio metric (Normalized Target Signal) within the BTZ was 4.0 ± 0.3. Total treatment times were all less than 35 minutes (34.3 ± 0.2). Prescription dose coverage to the CTV for all 4 fractions was 100%. Ion chamber measurements in the CTV were -1.6 ± 1.3% relative to the planned dose over the active area of the ion-chamber. Minimum and maximum doses to the CTV, measured on film, were -7.7 ± 2.2% and 1.3 ± 1.4%, calculated relative to the planned dose distribution, respectively. The OAR maximum point dose measured on film was -8.7 ± 2.9%, calculated relative to the maximum OAR dose predicted on the bounded dose-volume histogram. Based on this initial study, accurate and reproducible dosimetry can be achieved for targets under respiratory motion using biology-guided radiotherapy over the course of a complete course of treatment. Further studies are needed to evaluate the intrafraction dosimetry of BgRT delivery under various motion models and tumor sizes.

Mechanisms and implications of mitral regurgitation in patients with severe aortic stenosis who received transcatheter aortic valve replacement.

This study aimed to investigate the mechanisms and clinical implications of mitral regurgitation (MR) in patients with severe aortic stenosis (AS) who received transcatheter aortic valve replacement (TAVR). We conducted retrospective echocardiographic analyses at baseline and 6 months after TAVR in 140 patients with symptomatic AS (85±5 years) who underwent TAVR. We defined significant MR as ≥ moderate based on evaluation of transthoracic echocardiography (TTE). There were 48 patients (34%) with preexisting MR at the baseline. Among measured TTE parameters, end-systolic wall stress (ESWS), mitral annulus area, and mitral valve thickening index were independent factors associated with preexisting MR (odds ratio [OR]: 1.013, 95% confidence interval [CI]: 1.005-1.021; OR: 1.740, 95% CI: 1.314-2.376; OR: 2.306, 95% CI: 1.426-3.848; respectively). Six months after TAVR, there were 34 patients with post-existing MR, A history of atrial fibrillation and ESWS after TAVR were independent factors (OR: 3.013, 95% CI: 1.208-7.556; OR: 1.013, 95% CI: 1.000-1.023; respectively). The Kaplan-Meier plot indicated that preexisting MR was a risk factor for heart failure-related events within 1 year of discharge after TAVR (p=.012). In patients who underwent TAVR for severe AS, preexisting MR was associated with having a thickened mitral valve and large mitral annulus size induced by high ESWS. These patients may have worse prognosis after TAVR and should be closely monitored in the long term.

Transcatheter transseptal treatment of patients with severe mitral regurgitation using an atrial fixation mitral valve replacement technology

BackgroundMitral regurgitation (MR) is the most common valvular heart disease worldwide with a 5-year mortality rate of 50 % with medical therapy alone. Several transcatheter mitral valve replacement (TMVR) devices are being investigated in clinical trials. Early evidence has demonstrated clinical benefits with a reduction in heart failure symptoms, low rates of residual MR, and reverse remodeling of the left ventricle (LV) over time. However, high anatomical screen failure rates limit its applicability. The primary reasons for the anatomical screen failure are risk of LV outflow tract obstruction, large mitral valve annulus size, and the presence of mitral annular calcification. Our clinical experiences using an atrial only fixation TMVR technology delivered via a transfemoral-transseptal approach is described. MethodsThree consecutive patients with severe functional MR underwent TMVR implantation using an atrial only fixation technology and a low-profile transseptal delivery system. ResultsTechnical success was achieved in 100 % of the patients with a clinically significant reduction in MR. Longer-term follow-up (up to 6-months) has demonstrated a sustained reduction in MR and significant improvement in quality of life for all patients. ConclusionsLonger-term outcomes in our patients showed persistent reduction in MR, sustained implant performance, and notable improvements in NYHA Class and quality of life. There were no major adverse events. Follow-up CT data showed no evidence of device-related thrombosis, with stable valve position and integrity. The atrial fixation TMVR technology may have benefits in preserving the dynamics of the native mitral valve annulus thereby reducing the overall risk of LVOT obstruction. Short AbstractWe present a single-center experience of three consecutive patients with severe functional MR treated with the AltaValve using a low-profile transseptal delivery system. A clinically significant reduction in mitral regurgitation was achieved in all patients, and longer-term follow-up has demonstrated sustained clinical benefits.

Three-Year Outcomes of Balloon-Expandable Transcatheter Aortic Valve Implantation According to Annular Size

Data on the association between annular size and transcatheter aortic valve implantation (TAVI) outcomes beyond 1 year are limited. The present study assessed the association between the aortic annulus size and TAVI clinical and hemodynamic outcomes at 3years of follow-up. Patients were classified according to the aortic annulus size as having small, intermediate, and large annuli (size <400, 400 to 574, and ≥575mm2, respectively). The co-primary endpoints were all-cause mortality and heart failure hospitalization. Further, the changes in hemodynamic outcomes over the follow-up period (median 37, interquartile range: 26 to 45 months) were assessed. The present analysis included 850 patients, with 182 patients (21.4%), 538 patients (63.3%), and 130 patients (15.3%) in the small, intermediate, and large-sized aortic annulus groups, respectively. The groups had comparable age and pre-TAVI pressure gradients; however, patients with small annuli had higher Society of Thoracic Surgeons risk scores. Adjusted Cox regression analysis showed that compared to patients with intermediate-sized annuli, patients with small and large annuli had similar all-cause mortality (hazard ratio [HR]=1.11, 95% confidence interval [CI] 0.72 to 1.69 and HR=0.74, 95% CI 0.48 to 1.16, respectively) and heart failure hospitalization rates (HR=0.96, 95% CI 0.55 to 1.69 and HR=1.26, 95% CI 0.73 to 2.17, respectively). However, patients with small annuli had consistently higher mean and peak pressure gradients and a higher risk of patient-prosthesis mismatch. The risks of moderate-to-severe regurgitation and structural valve deterioration were similar between the three groups. In conclusion, although patients with small annuli had higher transvalvular gradients, there was no significant association between the aortic annulus size and TAVI clinical outcomes at 3years of follow-up. Future studies should compare the performance of transcatheter valve types in patients with different aortic annulus sizes.

Transcatheter Aortic Valve Replacement in Large Annuli Valves With the Supra-Annular, Self-Expandable Evolut Platform in a Real-World Registry.

Transcatheter aortic valve replacement is approved for treatment of patients with severe aortic stenosis across the spectrum of risk. While considering broader indications for use, transcatheter aortic valve replacement in large native annuli has become increasingly important. Patients with tricuspid aortic stenosis undergoing transcatheter aortic valve replacement using the Evolut R or Evolut PRO+ 34 mm valves (Medtronic, Minneapolis, MN) in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry between October 2016 and September 2020 were stratified according to in range (>12%) device oversizing and below range (0%-12%) device oversizing. Patients undergoing valve-in-valve procedures, having a baseline annulus size <26 or ≥34 mm, or without computed tomography angiography measured annulus size were excluded. Percentage of oversizing was calculated as [(valve diameter-annulus diameter)×100/annulus diameter]. Transcatheter aortic valve replacement in patients with large annuli was performed in 8017 patients with a mean (±SD) age 79.3±7.9 years and 94% were male. Below range (n=1096) was less common than in range oversizing (n=6921). At 1-year follow-up, mortality (19.6% versus 14.9%; P=0.001), aortic valve reintervention (2.1% versus 0.6%; P<0.001) and valve-related readmission rates (3.2% versus 2.0%; P=0.014) were higher in the below range device oversizing group versus in range group respectively. In a multivariable Cox proportional hazards regression model, when controlling for clinically relevant covariates, below range device oversizing was associated with higher 1-year all-cause mortality (HR, 1.28 [CI, 1.07-1.51]; P=0.005). Results from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry in patients with large annuli valves using 34mm Evolut R/PRO+ valves suggest that in range (>12%) device oversizing delivered better clinical outcomes than implantation with below range (0%-12%) device oversizing.

Comparison of outcomes in patients with severe aortic stenosis treated with small and large Medtronic Evolut R and Evolut PRO self-expandable prosthetic valves.

Indications for transcatheter aortic valve implantation (TAVI) continue to expand. Very often TAVI must be done in large annuli. Implantation of the bigger prostheses is often associated with more procedural problems, which may affect the outcomes. To compare the outcomes of TAVI procedures using the self-expandable Medtronic Evolut R 34 with the smaller Evolut R or Evolut Pro 23, 26 or 29. We analysed 87 patients who received self-expandable Medtronic Evolut R and Pro valves. Group I consisted of 59 (67.81%) patients with Evolut 23, 26 or 29, and group II consisted of 28 (32.18%) patients who received an Evolut 34 valve. EuroSCORE II was 5.59 in group I vs 7.87 in group II (p = 0.02). The oversizing rate was higher in group II: 24.1% vs. 18.5% (p < 0.001). The procedure and fluoroscopy times were longer in group II: 209 vs. 187 min (p = 0.03), 44 vs. 27 min (p = 0.01). Moderate paravalvular leak was found more frequently in group II: 5 v 1 (p = 0.04). There was less device success in group II: 22 (78.57%) vs. 57 (96.6%) (p = 0.05). Early safety criteria were similar in both groups: 52 (88.1%) and 24 (92.3%) (p = 0.56). 30-day mortality was similar: 4 (6.7%) vs. 0 in group I and II respectively (p = 0.16). TAVI procedures in patients requiring an Evolut R 34 prosthesis are more challenging than in those who need smaller valves. Paravalvular leaks are more frequently observed after TAVI with Evolut R 34, which results in lower device success.

Comparison of Outcomes of Different Balloon Sets in Patients undergoing Percutaneous Transvenous Mitral Commissurotomy – Bigger and Differ is Better!

Background: Although the Inoue balloon technique is said to be more popular worldwide for PTMC in those who have severe MS, the Bonhoeffer multi-track (double balloon technique) system is used in our center. On the other hand, it is unknown which balloon set size will produce the best results. The current study's objective is to assess the efficacy of different balloon sets utilized in symptomatic patients with moderate to severe mitral stenosis (MS) following percutaneous transvenous mitral commissurotomy (PTMC).&#x0D; Methodology: There were 203 consecutive patients. In 154 patients, a 14x14mm balloon set was used, and in the other 49 patients, a 14x16mm balloon set. PTMC was deemed successful when MVA 1.5 cm2 was attained with just minimal MR. Patients with valve areas less than 1.5 cm2 and more severe MR are regarded as failed.&#x0D; Results: With a 14x16mm balloon set, post-procedure examination revealed noticeably better accomplishment in the valve area (2.960.84 cm2 versus 3.260.95 cm2; P=0.024). With a 14x16mm balloon set, a tendency towards a lower post-procedure mean pressure gradient across the mitral valve was seen (6.052.19 mmHg versus 5.472.24 mmHg; P=0.107). There was no discernible change in post-procedure MR, tamponade, or procedural failure. However, there was no significant statistical difference in the treatment efficacy between the groups (87.7% with a 14x16mm balloon set versus 77.9% with a 14x14mm balloon set; P=0.153).&#x0D; Conclusion: A 14x16 mm balloon set might be a better and safer option, particularly for taller and older patients with larger annuli.

BgRT Motion Management Maintains Target Dose Coverage for Respiratory and Non-Respiratory Motion

<h3>Purpose/Objective(s)</h3> Biology-guided radiotherapy (BgRT) uses outgoing emissions after administration of an injected radiotracer to dynamically guide the delivery of radiation treatment to PET-avid targets. In this study, we evaluated the tracking performance of FDG-guided BGRT for two potential types of motion management (respiratory and non-respiratory (gastrointestinal)) while exploring different target shapes: spherical and non-spherical. BgRT is designed to ensure target coverage while keeping organ-at-risk (OAR) doses low. <h3>Materials/Methods</h3> A large custom anthropomorphic phantom with 2 robotic articulating arms was used to place a target and organ-at-risk inside a 27-liter water filled cavity. The targets consisted of an integrated ion chamber inside a 3D printed 22 mm sphere or a small non-spherical ovoid shape filled with FDG. The hot FDG-filled OAR consisted of either a 3D printed large C-shape annulus (mimicking a heart), large ovoid (mimicking a kidney), or a 30 mm sphere, all with integrated ion chambers. Both the 3D printed target and the OAR were filled with an 8:1 concentration ratio versus the water background. Three different 10 Gy/fraction treatment plans with two different target shapes and realistic nearby OARs were created with a 5 mm margin added to the CTV to generate the PTV. 3D printed targets and OARs were loaded with EBT-XD radiographic film. A 3D elliptical motion trajectory with breathing induced hysteresis with a maximum amplitude of +/- 12 mm was used for the respiratory motion model. An asymmetric slow-moving drift waveform with long-step shifts of +13/-5mm mm was used for the non-respiratory (gastrointestinal) motion model. Dosimetric results were evaluated based on 2-dimensional comparisons between measured film and planned dose distributions for the target and OAR. BgRT must maintain a prescription dose margin greater than 2 mm on the CTV for the three different motion experiments. Also, ion-chamber point dose and maximum film dose on the OAR must be within bounds predicted by the treatment planning system. <h3>Results</h3> BgRT was able to meet minimum margin requirements (a margin loss < 3mm) and meet prescription dose coverage in both motion management scenarios while maintaining OAR dose limits within the plan predicted bounds (see Table 1). <h3>Conclusion</h3> BgRT is able to provide motion management in complex cases that is agnostic to the type of motion. BgRT is able to maintain the PTV coverage with less than 3 mm reduction from the original 5mm margin.

Comparison of clinical outcomes between use of overexpanding an undersized versus nominal-sized SAPIEN 3 ultra transcatheter heart valve in patients with borderline annulus area.

For patients with borderline annulus areas that fall between two valve sizes, overinflating a smaller balloon-expandable transcatheter heart valve (THV) may be preferable to nominal sizing of a larger THV. To evaluate the outcomes of nominal preparation versus over-expanding an under-sized SAPIEN 3 Ultra (S3U) transcatheter heart valve (OE-THV) in cases with borderline annuli. 958 patients that underwent TAVR with the S3U at four high-volume TAVR centers between January 2017 and December 2020 were retrospectively reviewed. 336 patients were identified as borderline annuli size, of which 146 (44%) received OE-THVs and 190 (56%) received nominal-sized THVs. The primary composite endpoint included: in-hospital mortality, aortic injury, moderate/severe paravalvular leak (PVL), permanent pacemaker implant (PPM), stroke, or conversion to surgery. Baseline characteristics were similar except for a larger percentage of females in the OE-THV (53.42% vs. 42.11%, p = 0.04). TAVR with OE-THV resulted a reduction in the primary composite endpoint (13.69% vs. 22.63%, p = 0.04). On subgroup analysis, there was no difference between 20 mm OE-THV versus 23 mm nominal or 23 mm OE-THV versus 26 mm nominal, but there was a reduction in the primary composite endpoint in patients with larger annuli that received a 26 mm OE-THV compared to the 29 mm nominally sized THV (9.7% vs. 27.4%, p = 0.02). At 1 month and 1 year follow-up, there was no significant difference in mortality, PVL rates, NYHA class, and/or KCCQ score. Overinflating a smaller-sized S3U THV may be a safer option in comparison to nominal sizing in patients with borderline annular area.

It’s Never too Late: Late-Stage Aortic Stenosis Treated With Transcatheter Aortic Valve In A Patient With Significant Aortic Root Enlargement With Measurements Beyond Those Recommended By The Valve Manufacturers

A patient with severe calcific bicuspid aortic valve stenosis, revealed by Transthoracic Echocardiogram (TEE), was markedly symptomatic with recurrent decompensation of diastolic heart failure. TEE also revealed moderate insufficiency with large annulus measurements beyond the parameters of currently available valve prostheses. Most valve companies initially declined to provide their device due to the size mismatch, raising concern about valve embolization and potential residual paravalvular leak (PVL). Ultimately, we decided that the calcification in both leaflets may be able to hold onto a 29 mm Edwards-SAPIEN valve, and after a prolonged informed consent the patient was considered for TAVR.