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Background--Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) may be less effective in small surgical valves because of patient/prosthesis mismatch. Bioprosthetic valve fracture (BVF) using a high-pressure balloon can be performed to facilitate VIV TAVR. Methods and Results--We report data from 20 consecutive clinical cases in which BVF was successfully performed before or after VIV TAVR by inflation of a high-pressure balloon positioned across the valve ring during rapid ventricular pacing. Hemodynamic measurements and calculation of the valve effective orifice area were performed at baseline, immediately after VIV TAVR, and after BVF. BVF was successfully performed in 20 patients undergoing VIV TAVR with balloon- expandable (n=8) or self-expanding (n=12) transcatheter valves in Mitroflow, Carpentier-Edwards Perimount, Magna and Magna Ease, Biocor Epic and Biocor Epic Supra, and Mosaic surgical valves. Successful fracture was noted fluoroscopically when the waist of the balloon released and by a sudden drop in inflation pressure, often accompanied by an audible snap. BVF resulted in a reduction in the mean transvalvular gradient (from 20.5±7.4 to 6.7±3.7 mm Hg, P<0.001) and an increase in valve effective orifice area (from 1.0±0.4 to 1.8±0.6 cm², P<0.001). No procedural complications were reported. Conclusions--BVF can be performed safely in small surgical valves to facilitate VIV TAVR with either balloon-expandable or self-expanding transcatheter valves and results in reduced residual transvalvular gradients and increased valve effective orifice area. [ABSTRACT FROM AUTHOR]

Background: Rehospitalization is a common end point in clinical trials of structural heart interventions, but whether rehospitalization is clinically and prognostically relevant in these patients is uncertain. The aim of this study was to evaluate the risk of rehospitalization events after aortic valve replacement (AVR) and their association with mortality and health status. Methods: The study population included patients who underwent transcatheter or surgical AVR in the PARTNER I‚ II‚ and III trials (Placement of Aortic Transcatheter Valves). Health status was assessed with the Kansas City Cardiomyopathy Questionnaire-overall summary score. The primary analysis focused on heart failure hospitalization within 1 year after AVR and its association with mortality, poor outcome (death, Kansas City Cardiomyopathy Questionnaire-overall summary score <60 or decrease by ≥10), and health status at 1 year using adjusted models. Secondary analyses examined the prognostic associations of rehospitalization due to a composite of heart failure, valve-related, or procedure-related causes. Results: Among 3403 patients treated with AVR (2008 transcatheter AVR, 1395 surgical AVR), the 1-year incidence was 6.7% for heart failure hospitalization and 9.7% for rehospitalization due to a composite of heart failure, valve-related, or procedure-related causes. Heart failure hospitalization after AVR was associated with increased risk of 1-year mortality (hazard ratio, 3.97 [2.48 to 6.36]; P <0.001), poor outcome (OR, 2.76 [1.73 to 4.40]; P <0.001), and worse health status (Kansas City Cardiomyopathy Questionnaire-overall summary mean difference −9.8 points [−13.8 to −5.8]; P <0.001). Rehospitalization due to a composite of heart failure, valve-related, or procedure-related causes was similarly associated with increased 1-year mortality (hazard ratio, 4.64 [3.11 to 6.92]; P <0.001), poor outcome (OR, 2.06 [1.38 to 3.07]; P =0.0004), and worse health status (Kansas City Cardiomyopathy Questionnaire-overall summary mean difference −8.8 points [−11.8 to −5.7]; P <0.001). There was no effect modification by treatment type (transcatheter AVR versus surgical AVR) for these associations. Conclusions: Heart failure hospitalization and rehospitalization after AVR are associated with increased risk of mortality and worse 1-year health status. These findings confirm the clinical and prognostic relevance of rehospitalization end points for trials of AVR. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00530894. [ABSTRACT FROM AUTHOR]

Improving functional status and quality of life are important goals of treatment for patients with severe aortic stenosis. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a heart failure health status measure and has been used in studies of patients with aortic stenosis. However, its psychometric properties have not yet been evaluated in these patients.We analyzed data from 955 patients, enrolled in the PARTNER trial of transcatheter aortic valve replacement, to evaluate the reliability, responsiveness, validity, and prognostic importance of the KCCQ in patients with severe aortic stenosis. The KCCQ was administered at baseline and at 1, 6, and 12 months after randomization to medical therapy, transcatheter aortic valve replacement, or surgical valve replacement. Among clinically stable patients, there were only small changes in the KCCQ domain scores over time (mean differences 0.1-4.2 points), and the intraclass correlation coefficients showed good agreement between paired assessments (0.65-0.76). However, the domain scores of patients who underwent transcatheter aortic valve replacement showed large changes after treatment (mean differences 13-30 points). Construct validity was demonstrated by comparing each domain against a relevant reference measure (Spearman correlations 0.46-0.69). Finally, among 157 patients randomized to medical management, lower KCCQ overall summary scores at baseline were strongly associated with an increased risk of mortality during the following 12 months.The KCCQ is a highly reliable, responsive, and valid measure of symptoms, functional status, and quality of life in patients with severe, symptomatic aortic stenosis. [ABSTRACT FROM AUTHOR]

This article examines the calculation of shielding barrier thicknesses for radiation therapy facilities according to the National Council on Radiation Protection and Measurements (NCRP) formalism. This study was made to determine the tenth value layers (TVLs) for various beam modalities as a function of field size. The study found that the data for large angles agrees with the NCRP report No. 151 but at the smaller angles the TVL values were significantly less, meaning that thinner shielding walls could be used. For machines that are dedicated to specific procedures this change could be significant in view of the small field sizes used.

The x-ray leakage from the housing of a therapy x-ray source is regulated to be <0. 1% of the useful beam exposure at 1 m from the source. It is to be expected that the machine leakage in the backward direction would be less because the gantry and stand contain significant amounts of additional metal to attenuate the x rays. A reduction in head leakage in this direction will have a direct effect on the thickness of the shielding wall behind the linear accelerator. However, no reports have been published to date on measurements in this area. The x-ray leakage in the backward direction has been measured from linacs having energies of 4, 6,10, 15, and 18 MV using a 100 cm3 ionization chamber and A12O3,/sub> dosimeters. The leakage was measured at nine different positions over the rear wall using a 3 X 3 matrix with a 1-m separation between adjacent horizontal and vertical points with either the leftmost or rightmost column aligned with the target and isocenter. In general, the leakage is less than the canonical value, but the exact value depends on energy, gantry angle, and measurement position. There is significantly greater attenuation directly behind the gantry stand for all energies. Leakage at 10 MV for some positions exceeded 0. 1%. Additionally, neutron leakage measurements were made for 10,15, and 18 MV x-ray beams using track-etch detectors. The average neutron leakage was less than 0. 1% except for 18 MV, where neutron leakage was more than 0. 1% of the useful beam at some positions.

Background: Clinical trials have demonstrated health status benefit of transcatheter mitral valve repair (TMVr) with MitraClip in patients with mitral valve regurgitation. Real-world site-level variability in health status outcomes for TMVr, and factors associated with this variability, are unknown.Methods: All patients undergoing TMVr procedure with MitraClip between November 2013 and March 2019 in the Transcatheter Valve Therapy Registry were included. Health status was measured at baseline and 30 days with the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score. Site-level variability in 30-day change in KCCQ-OS was examined by calculating the median odds ratio from a hierarchical logistic regression model, with ≥20-point improvement as the dependent variable. To define the extent to which patient characteristics, procedural characteristics (residual mitral valve regurgitation, periprocedural bleeding), site volume, and patients' baseline health status accounted for variability in outcomes, the proportion of variability (R2) explained by sequentially adding these variables to the model was quantified.Results: Across 339 sites, 12 415 patients (mean age 79.0±9.5 years, 46.1%. females, 89.5% White) completed baseline and 30-day health status assessments. Mean KCCQ-OS score was 43.0±24.4 at baseline and 67.0±24.9 at 30-day follow-up. Across sites, the proportion of patients achieving a ≥20-point improvement in KCCQ-OS ranged from 12.5% to 100% and the adjusted median odds ratio was 1.58 (95% CI, 1.46-1.69). The greatest contribution to the variability in health status outcomes was from patients' baseline KCCQ-OS score (R2=25%) with <1% of the variability explained by patient and procedural characteristics, and annual site volume.Conclusions: There is moderate variation across sites in their patients' achievement of health status benefits from TMVr, with patient's baseline health status accounting for the largest proportion of this variation. This underscores the importance of patient selection in supporting more consistent health status benefit from TMVr. [ABSTRACT FROM AUTHOR]

Background Drug-eluting stents reduce the risk of restenosis in patients undergoing percutaneous coronary intervention, but their use necessitates prolonged dual antiplatelet therapy, which increases costs and bleeding risk, and which may delay elective surgeries. While >80% of patients in the United States receive drug-eluting stents, less than a third report that their physicians discussed options with them. Methods and Results An individualized shared decision-making (SDM) tool for stent selection was designed and implemented at 2 US hospitals. In the postimplementation phase, all patients received the SDM tool before their procedure, with or without decision coaching from a trained nurse. All patients were interviewed with respect to their knowledge of stents, their participation in SDM, and their stent preference. Between May 2014 and December 2016, 332 patients not receiving the SDM tool, 113 receiving the SDM tool with coaching, and 136 receiving the tool without coaching were interviewed. Patients receiving the SDM tool + coaching, as compared with usual care, demonstrated higher knowledge scores (mean difference +1.8; P<0.001), reported more frequent participation in SDM (odds ratio=2.96; P<0.001), and were more likely to state a stent preference (odds ratio=2.00; P<0.001). No significant differences were observed between the use of the SDM tool without coaching and usual care. For patients who voiced a stent preference, concordance between stent desired and stent received was 98% for patients who preferred a drug-eluting stent and 50% for patients who preferred a bare metal stent. The SDM tool (with or without coaching) had no impact on stent selection or concordance. Conclusions An SDM tool for stent selection was associated with improvements in patient knowledge and SDM only when accompanied by decision coaching. However, the SDM tool (with or without coaching) had no impact on stent selection or concordance between patients' stent preference and stent received, suggesting that physician-level barriers to SDM may exist. Clinical Trial Information URL: https://www.clinicaltrials.gov . Unique Identifier: NCT02046902. [ABSTRACT FROM AUTHOR]

Background: Coronary accessibility following redo-transcatheter aortic valve replacement (redo-TAVR) is increasingly important, particularly in younger low-risk patients. This study aimed to predict coronary accessibility after simulated Sapien-3 balloon-expandable valve implantation within an Evolut supra-annular, self-expanding valve using pre-TAVR computed tomography (CT) imaging., Methods: A total of 219 pre-TAVR CT scans from the Evolut Low-Risk CT substudy were analyzed. Virtual Evolut and Sapien-3 valves were sized using CT-based diameters. Two initial Evolut implant depths were analyzed, 3 and 5 mm. Coronary accessibility was evaluated for 2 Sapien-3 in Evolut implant positions: Sapien-3 outflow at Evolut node 4 and Evolut node 5., Results: With a 3-mm initial Evolut implant depth, suitable coronary access was predicted in 84% of patients with the Sapien-3 outflow at Evolut node 4, and in 31% of cases with the Sapien-3 outflow at Evolut node 5 ( P <0.001). Coronary accessibility improved with a 5-mm Evolut implant depth: 97% at node 4 and 65% at node 5 ( P <0.001). When comparing 3- to 5-mm Evolut implant depth, sinus sequestration was the lowest with Sapien-3 outflow at Evolut node 4 (13% versus 2%; P <0.001), and the highest at Evolut node 5 (61% versus 32%; P <0.001)., Conclusions: Coronary accessibility after Sapien-3 in Evolut redo-TAVR relates to the initial Evolut implant depth, the Sapien-3 outflow position within the Evolut, and the native annular anatomy. This CT-based quantitative analysis may provide useful information to inform and refine individualized preprocedural CT planning of the initial TAVR and guide lifetime management for future coronary access after redo-TAVR., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02701283., Competing Interests: Disclosures Dr Tang is a physician proctor, consultant, and physician advisory board member for Medtronic, a consultant and physician advisory board member for Abbott Structural Heart, a consultant for NeoChord, and a physician advisory board member for JenaValve and Boston Scientific. He has received Speaker Honoraria for Siemens Healthineers and East End Medical. Dr Spencer is an employee and shareholder of Medtronic. Dr Rogers is a consultant and physician proctor to Edwards Lifesciences, Medtronic and Boston Scientific; is an Advisory Board member to Medtronic; has equity in Transmural Systems; and is a co-inventor on patents, assigned to National Institutes of Health, for transcatheter electrosurgery devices. Dr Grubb is a proctor, principal investigator and on the advisory board for Medtronic, serves on the advisory board or is a consultant for Ancora Heart, Boston Scientific, Abbott, 4C Medical, Gore, BioVentrix, and Edwards Lifesciences. Dr Gleason’s employer receives institutional grants and educational funding from Edwards Lifesciences, Abbott and Medtronic; he has no personal financial disclosures. Dr Gada has served as a consultant to Abbott, Bard Medical Corporation, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Mahoney is a proctor and consultant for Medtronic, Edwards, and Boston Scientific. Dr Dauerman is a consultant for Boston Scientific and Medtronic, and has received grant support from Boston Scientific and Medtronic. Dr Forrest has received grant support/research contracts and consultant fees/honoraria/speakers’ bureau fees from Edwards Lifesciences and Medtronic. Dr Reardon has received fees to his institution from Medtronic for consulting and providing educational services. Dr Blanke holds institutional research core laboratory agreements with Medtronic, Edwards Lifesciences, and Abbott with no personal compensation. Dr Leipsic holds institutional research core laboratory agreements with Medtronic, Edwards Lifesciences, Abbott, Boston Scientific, and Pi CARDIA with no personal compensation. Dr Abdel-Wahab’s institution receives speaker’s honoraria and consultancy fees on his behalf from Abbott, Boston Scientific, and Medtronic. Dr Attizzani is a consultant, serves as a proctor and is on the advisory board of Medtronic and is a consultant for Abbott Vascular. Dr Puri is a consultant, speaker and proctor for Medtronic, consults for Centerline Biomedical, Boston Scientific, Abbott, Philips, Products & Features, Shockwave Medical, VDyne, VahatiCor, Advanced Nanotherapies, NuevoSono, TherOx, GE Healthcare, BioVentrix, Protembis, and has equity interest in Centerline Biomedical, VahatiCor and NuevoSono. Dr Caskey reports proctor fees from Medtronic. Dr Chen is a proctor and is an advisory board member for Medtronic. Dr Allen has received grant support, proctor and speakers’ bureau fees from Edwards Lifesciences, Medtronic and Abbott with no personal compensation. Dr Chhatriwalla is a proctor for Edwards Lifesciences and Medtronic Inc, is on the speakers bureau for Abbott Vascular, Edwards Lifesciences and Medtronic Inc, and has a research grant from Boston Scientific. Dr Htun is a consultant for Medtronic. Dr Blackman is a proctor and consultant for Medtronic and Abbott Vascular, and a consultant for Edwards Lifesciences and Boston Scientific. Dr Tarantini has received lecture fees from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific. Dr Zhingre Sanchez is an employee and shareholder of Medtronic. Dr Popma is an employee and shareholder of Medtronic. Dr Sathananthan is a consulta nt to Edwards Lifesciences and Medtronic; and has received speaking fees from Edwards Lifesciences and NVT. The other authors report no conflicts.

Background: Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device., Methods and Results: A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%)., Conclusions: In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.

The calculation of shielding barrier thicknesses for radiation therapy facilities according to the NCRP formalism is based on the use of broad beams (that is, the maximum possible field sizes). However, in practice, treatment fields used in radiation therapy are, on average, less than half the maximum size. Indeed, many contemporary treatment techniques call for reduced field sizes to reduce co-morbidity and the risk of second cancers. Therefore, published tenth value layers (TVLs) for shielding materials do not apply to these very small fields. There is, hence, a need to determine the TVLs for various beam modalities as a function of field size. The attenuation of (60)Co gamma rays and photons of 4, 6, 10, 15, and 18 MV bremsstrahlung x ray beams by concrete has been studied using the Monte Carlo technique (MCNP version 4C2) for beams of half-opening angles of 0 degrees , 3 degrees , 6 degrees , 9 degrees , 12 degrees , and 14 degrees . The distance between the x-ray source and the distal surface of the shielding wall was fixed at 600 cm, a distance that is typical for modern radiation therapy rooms. The maximum concrete thickness varied between 76.5 cm and 151.5 cm for (60)Co and 18 MV x rays, respectively. Detectors were placed at 630 cm, 700 cm, and 800 cm from the source. TVLs have been determined down to the third TVL. Energy spectra for 4, 6, 10, 15, and 18 MV x rays for 10 x 10 cm(2) and 40 x 40 cm(2) field sizes were used to generate depth dose curves in water that were compared with experimentally measured values.