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Background The PINNACLE FLX (Protection Against Embolism for Non‐valvular AF [Atrial Fibrillation] Patients: Investigational Device Evaluation of the Watchman FLX LAA [Left Atrial Appendage] Closure Technology) trial evaluated the safety and efficacy of a next‐generation left atrial appendage closure device (WATCHMAN FLX; Boston Scientific, Marlborough, MA). At 1 year, the study met the primary end points of safety and anatomical efficacy/appendage closure. This final report of the PINNACLE FLX trial includes the prespecified secondary end point of ischemic stroke or systemic embolism at 2 years, also making it the first report of 2‐year outcomes with this next‐generation left atrial appendage closure device. Methods and Results Patients with nonvalvular atrial fibrillation with CHA 2 DS 2 ‐VASc score ≥2 (men) or ≥3 (women), with an appropriate rationale for left atrial appendage closure, were enrolled to receive the left atrial appendage closure device at 29 US centers. Adverse events were assessed by an independent clinical events committee, and imaging was assessed by independent core laboratories. Among 395 implanted patients (36% women; mean age, 74 years; CHA 2 DS 2 ‐VASc, 4.2±1.5), the secondary efficacy end point of 2‐year ischemic stroke or systemic embolism was met, with an absolute rate of 3.4% (annualized rate, 1.7%) and an upper 1‐sided 95% confidence bound of 5.3%, which was superior to the 8.7% performance goal. Two‐year rates of adverse events were as follows: 9.3% all‐cause mortality, 5.5% cardiovascular death, 3.4% all stroke, and 10.1% major bleeding (Bleeding Academic Research Consortium 3 or 5). There were no additional systemic embolisms, device embolizations, pericardial effusions, or symptomatic device‐related thrombi after 1 year. Conclusions The secondary end point of 2‐year stroke or systemic embolism was met at 3.4%. In these final results of the PINNACLE FLX trial, the next‐generation WATCHMAN FLX device demonstrated favorable safety and efficacy outcomes.

Mitral valve transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with secondary mitral regurgitation (SMR). The purpose of this analysis is to report contemporary real-world outcomes in SMR patients treated with 3EXPAND is a prospective, multi-center, international, single arm study with 1041 patients treated for MR with MitraClip NTR/XTR, with 30-day and 1-year follow-up (FU). All echocardiograms were analyzed by an independent echocardiographic core lab. Study outcomes included: procedural outcomes, durability of MR reduction, and major adverse events including all-cause mortality and hospitalizations for heart failure (HFH). A subgroup of 413 symptomatic patients (age 74.7±10.1 years, 58% male) with severe SMR were included. MR reduction to MR≤1+ and MR≤2+ was achieved in 93.0% and 98.5% of patients, respectively, which was sustained at 1-year-FU. All-cause mortality was 17.7% at 1-year-FU, and the combined endpoint of all-cause mortality or 1Under real-world conditions, optimal sustained MR reduction to MR≤1+ was achieved in a high percentage of patients with 3

Objectives This study sought to determine the safety of the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure. Background Transcatheter aortic valve replacement causes coronary artery obstruction in 0.7% of cases, with 40% to 50% mortality. BASILICA is a procedure to prevent coronary obstruction. Safety and feasibility in a large patient cohort is lacking. Methods The international BASILICA registry was a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and transcatheter aortic valve replacement. Valve Academic Research Consortium-2 definitions were used to adjudicate events. Results Between June 2017 and December 2020, 214 patients were included from 25 centers in North America and Europe; 72.8% had bioprosthetic aortic valves and 78.5% underwent solo BASILICA. Leaflet traversal was successful in 94.9% and leaflet laceration in 94.4%. Partial or complete coronary artery obstruction was seen in 4.7%. Procedure success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was achieved in 86.9%. Thirty-day mortality was 2.8% and stroke was 2.8%, with 0.5% disabling stroke. Thirty-day death and disabling stroke were seen in 3.4%. Valve Academic Research Consortium-2 composite safety was achieved in 82.8%. One-year survival was 83.9%. Outcomes were similar between solo and doppio BASILICA, between native and bioprosthetic valves, and with the use of cerebral embolic protection. Conclusions BASILICA is safe, with low reported rates of stroke and death. BASILICA is feasible in the real-world setting, with a high procedure success rate and low rates of coronary artery obstruction.

Objectives The purpose of this study was to evaluate tip-to-base intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) in patients undergoing transcatheter mitral valve replacement (TMVR) in annuloplasty rings or surgical mitral valves. Background LAMPOON is an effective adjunct to TMVR that prevents left ventricular outflow tract obstruction (LVOTO). Laceration is typically performed from the base to the tip of the anterior mitral leaflet. A modified laceration technique from leaflet tip to base may be effective in patients with a prosthesis that protects the aortomitral curtain. Methods This is a multicenter, 21-patient, consecutive retrospective observational cohort. Patients underwent tip-to-base LAMPOON to prevent LVOTO and leaflet overhang, or therapeutically to lacerate a long anterior mitral leaflet risking or causing LVOTO. Outcomes were compared with findings from patients in the LAMPOON investigational device exemption trial with a prior mitral annuloplasty. Results Twenty-one patients with a annuloplasty or valve prosthesis–protected mitral annulus underwent tip-to-base LAMPOON (19 preventive, 2 rescue). Leaflet laceration was successful in all and successfully prevented or treated LVOTO in all patients. No patients had significant LVOTO upon discharge. There were 2 cases of unintentional aortic valve injury (1 patient underwent emergency transcatheter aortic valve replacement and 1 patient underwent urgent surgical aortic valve replacement). In both cases, the patients had a supra-annular ring annuloplasty, and the retrograde aortic guiding catheter failed to insulate the guidewire lacerating surface from the aortic root. All patients survived to 30 days. Compared with classic retrograde LAMPOON, there was a trend toward shorter procedure time. Conclusions Tip-to-base laceration is a simple, effective, and safe LAMPOON variant applicable to patients with an appropriately positioned mitral annular ring or bioprosthetic valve. Operators should take care to insulate the lacerating surface from adjacent structures.

We present a case series of 4 iatrogenic ascending aortic pseudoaneurysms that were all successfully repaired with a percutaneous approach. Pre-procedural imaging, device selection, and procedural techniques are described. With careful preparation and patient selection, catheter closure of iatrogenic ascending aortic pseudoaneurysms can be performed reliably and safely. (Level of Difficulty: Advanced.), Graphical abstract

The aim of this study was to characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile delivery system (DS).Key design modifications to the FlexNav DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in vessels with diameter ≥5 mm.Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.S. IDE Trial] [n = 134] and the FlexNav EU CE Mark Study [n = 46]) for the analysis. The primary endpoint was Valve Academic Research Consortium-2-defined major vascular complications at 30 days. Clinical outcomes and valve performance were assessed through 30 days by an independent clinical events committee and an echocardiography core laboratory, respectively.One hundred forty high-risk and 40 extreme-risk subjects enrolled between October 15, 2018, and December 10, 2019, from 28 sites in the United States, Australia, and Europe who underwent attempted transfemoral Portico valve implantation were included. The mean age was 85.1 ± 5.6 years, 60% were women, the mean Society of Thoracic Surgeons score was 5.3%, and 96.1% presented with ≥1 frailty factor. Technical device success was 96.7%. At 30 days, the rate of major vascular complications was 5.0%, with 4.4% of complications adjudicated as access site-related (3.3% transcatheter aortic valve replacement DS access site-related). Death (0.6%) and disabling stroke (1.1%) were rare. The rate of new permanent pacemaker implantation was 15.4%. Echocardiography revealed a mean gradient of 7.1 ± 3.2 mm Hg, mean valve area of 1.77 ± 0.41 cmPortico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days.

Objectives The aim of this study was to report the 2-year results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial and confirm the interim Bayesian analysis. Background Transcatheter aortic valve replacement (TAVR) with a self-expanding valve was noninferior to surgery in patients with severe aortic stenosis and intermediate operative risk using Bayesian statistical methods. Novel Bayesian designs have been used to shorten the time to primary endpoint analysis in randomized clinical trials, although the predictive value of Bayesian analysis compared with frequentist approaches remains debated. Methods The SURTAVI trial randomized 1,660 patients. An interim analysis was performed 1 year after the 1,400th patient was treated to estimate the primary 2-year endpoint of all-cause mortality or disabling strokes for all patients. Results The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: −3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (−1.4% difference; Bayesian credible interval: −5.2% to 2.3%) in the interim Bayesian analysis. A comparison of individual clinical, hemodynamic, and quality-of-life endpoints using Bayesian and frequentist methods found no significant differences. Conclusions The complete analysis of all patients with aortic stenosis at intermediate risk for surgery in the SURTAVI trial confirmed the noninferiority, with respect to the frequency of all-cause mortality or disabling stroke, of TAVR to surgery, as determined in the interim Bayesian analysis. Follow-up will extend out to 10 years.

Background The SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial was designed to compare the performance of the two most widely available commercial transcatheter aortic valve replacement (TAVR) devices in patients with symptomatic severe native aortic stenosis with a small aortic valve annulus undergoing transfemoral TAVR. Patients with small aortic valve annuli are typically female and are often underrepresented in clinical trials. Methods The SMART Trial is an international, prospective, multi-center, randomized controlled, post-market trial. The trial will be conducted in approximately 700 subjects at approximately 90 sites globally. Inclusion criteria include severe aortic stenosis, aortic valve annulus area of ≤430 mm2 based on multi-detector computed tomography (MDCT), and appropriate anatomy for both the Medtronic Evolut PRO/PRO+ self-expanding (SE) and Edwards SAPIEN 3/3 Ultra balloon-expandable (BE) devices. The primary clinical outcome composite endpoint is defined as mortality, disabling stroke or heart failure rehospitalization at 12 months. The co-primary valve function composite endpoint is defined as bioprosthetic valve dysfunction (BVD) at 12 months which includes hemodynamic structural valve dysfunction (HSVD), defined as a mean gradient ≥20 mmHg, non-structural valve dysfunction (NSVD), defined as severe prothesis-patient mismatch (PPM) or ≥moderate aortic regurgitation (AR), thrombosis, endocarditis, and aortic valve re-intervention. Powered secondary endpoints will be assessed hierarchically. Conclusions The SMART trial will be the largest head-to-head comparative trial of transfemoral TAVR using the two most widely available contemporary TAVR devices in the setting of small aortic annuli and the largest trial to enroll primarily women. Clinical trial registration www.clinicaltrials.gov, NCT04722250.

OBJECTIVES We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site. BACKGROUND The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site. METHODS Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed. RESULTS A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p

Background Prospective bicuspid low-risk transcatheter aortic valve replacement (TAVR) registries' data demonstrated encouraging short-term results. Detailed data on transcatheter heart valve (THV) geometry after deployment using contemporary devices are lacking. This study sought to examine valve geometry after TAVR in patients with bicuspid aortic stenosis (AS). Methods The study population was patients from the LRT (Low Risk TAVR) trial who underwent TAVR using the SAPIEN 3 THV for bicuspid and tricuspid AS. THV geometry measured on 30-day computed tomography (CT) included valve height, angle, depth, and eccentricity. Additionally, THV hemodynamics and outcomes post-TAVR were compared among patients with bicuspid and tricuspid AS. Results A total of 107 patients from the LRT trial using the SAPIEN 3 THV were included in our analysis. On 30-day CT, the valve height ratio (1.07 vs. 1.07; p = 0.348), depths (right [5.6 mm vs. 6.2 mm; p = 0.223], left [5.3 mm vs. 4.4 mm; p = 0.082] and non [4.8 mm vs. 4.5 mm; p = 0.589] coronary cusps), eccentricities (1.08 vs. 1.07; p = 0.9550), and angles (except the right [3.9 degrees vs. 6.3 degrees; p = 0.003] and left [3.6 degrees vs. 6.0 degrees; p = 0.007]) were similar between bicuspid and tricuspid patients. Hemodynamics, stroke, and mortality were similar at 1 year. Conclusion Despite challenging bicuspid anatomy of the aortic valve , our comprehensive CT analysis supports similar THV geometry between patients with bicuspid and tricuspid AS undergoing TAVR using the SAPIEN 3 THV in low-risk patients. This translated to excellent short-term clinical outcomes and THV hemodynamics in both aortic valve morphologies. Trial registry NCT02628899 , https://clinicaltrials.gov/ct2/show/NCT02628899 .

This study sought to determine the safety of the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure.Transcatheter aortic valve replacement causes coronary artery obstruction in 0.7% of cases, with 40% to 50% mortality. BASILICA is a procedure to prevent coronary obstruction. Safety and feasibility in a large patient cohort is lacking.The international BASILICA registry was a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and transcatheter aortic valve replacement. Valve Academic Research Consortium-2 definitions were used to adjudicate events.Between June 2017 and December 2020, 214 patients were included from 25 centers in North America and Europe; 72.8% had bioprosthetic aortic valves and 78.5% underwent solo BASILICA. Leaflet traversal was successful in 94.9% and leaflet laceration in 94.4%. Partial or complete coronary artery obstruction was seen in 4.7%. Procedure success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was achieved in 86.9%. Thirty-day mortality was 2.8% and stroke was 2.8%, with 0.5% disabling stroke. Thirty-day death and disabling stroke were seen in 3.4%. Valve Academic Research Consortium-2 composite safety was achieved in 82.8%. One-year survival was 83.9%. Outcomes were similar between solo and doppio BASILICA, between native and bioprosthetic valves, and with the use of cerebral embolic protection.BASILICA is safe, with low reported rates of stroke and death. BASILICA is feasible in the real-world setting, with a high procedure success rate and low rates of coronary artery obstruction.

Background: The optimal antithrombotic regimen after transcatheter aortic valve replacement remains unclear. Methods: In this randomized open-label study, low-risk patients undergoing transfemoral transcatheter aortic valve replacement at 7 centers in the United States were randomized 1:1 to low-dose aspirin or warfarin plus low-dose aspirin for 30 days. Patients who could not be randomized were enrolled in a separate registry. Computed tomography or transesophageal echocardiography was performed at 30 days. The primary effectiveness end point was a composite of the following at 30 days: hypoattenuated leaflet thickening, at least moderately reduced leaflet motion, hemodynamic dysfunction (mean aortic valve gradient ≥20 mm Hg, effective orifice area ≤1.0 cm 2 , dimensionless valve index Results: Between July 2018 and October 2019, 94 patients were randomly assigned, 50 to aspirin and 44 to warfarin plus aspirin, and 30 were enrolled into the registry. In the intention-to-treat analysis of the randomized cohort, the composite primary effectiveness end point was met in 26.5% for aspirin versus 7.0% for warfarin plus aspirin ( P =0.014; odds ratio, 4.8 [95% CI, 1.3–18.3]). The rate of hypoattenuated leaflet thickening was 16.3% for aspirin versus 4.7% for warfarin plus aspirin ( P =0.07; odds ratio, 4.0 [95% CI, 0.8–20.0]). There was no excess bleeding at 30 days with anticoagulation. In the as-treated analysis of pooled randomized and registry cohorts, the rate of hypoattenuated leaflet thickening was 16.7% for aspirin versus 3.1% for warfarin plus aspirin ( P =0.011; odds ratio, 6.3 [95% CI, 1.3–30.6]). Conclusions: In low-risk transcatheter aortic valve replacement patients, anticoagulation with warfarin may prevent transcatheter heart valve dysfunction in the short term without excess bleeding. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03557242.

Multiple alternative access routes have been employed for patients with contraindications to standard transfemoral transcatheter aortic valve replacement (TAVR); however, the optimal route for alternative access approaches is not established. In order to better understand possible differences in alternative access routes, we compared the procedural efficacy and outcomes at 30 days and 1 year in patients who underwent TAVR via subclavian (SC) or transcaval (TC) access route at a single, tertiary-care center.This retrospective analysis included all TAVR procedures performed via SC or TC approaches between December 2011 to January 2020, with outcomes reported to 1 year post procedure. Additional safety and feasibility studies, including successful device deployment, procedural time, blood loss, and total hospitalization length, are included as part of this study.A total of 41 patients underwent SC access and 22 patients underwent TC access for TAVR. Between both cohorts, SC patients were older at the time of TAVR (83.2 ± 3.7 years for SC vs 80.7 ± 3.9 years for TC; P=.03) and all patients were previously deemed high or prohibitive surgical risk (Society of Thoracic Surgeons score, aortic valve replacement only: 10.4 ± 2.6% for SC vs 9.0 ± 1.9% for TC; P=.12), with similar preoperative hemodynamic profiles.Device deployment was successful in all patients in both groups, with longer procedural times noted in the SC cohort (62.1 ± 12.1 minutes for SC vs 39.8 ± 12.5 minutes for TC; P.05). There were no in-hospital deaths in the SC group and 1 intraoperative death in the TC group that was unrelated to access route. Average length of hospital stay was consistent between the two groups (3.8 ± 1.4 days for SC vs 3.4 ± 1.1 days for TC; P=.06). More cerebrovascular accidents were noted in the SC group at 30 days (6 for SC vs 1 for TC), 6 months (3 for SC vs 0 for TC), and 1 year (2 for SC vs 0 for TC), with more postprocedural permanent pacemakers implanted in the SC group at 30 days (9 for SC vs 3 for TC; P.05, but with fewer at 6 months (2 for SC vs 3 for TC) and 1 year (1 for SC vs 2 for TC). Mortality rate was not statistically different between the two groups at 30 days, 6 months, and 1 year (P.05 for all).Both SC and TC access routes can be safe and feasible options for TAVR in patients at increased or prohibitive surgical risk with contraindications to standard transfemoral access.

Patient prosthesis mismatch (PPM) is an iatrogenic complication that occurs in patients who undergo surgical aortic valve replacement (SAVR). PPM occurs when the implanted surgical valve has an effective orifice area (EOA) that is too small for the patient, resulting in a gradient across the valve despite an otherwise normally functioning prosthesis. PPM has been associated with mid- and long-term increased morbidity and mortality. When this occurs, repeat SAVR with root enlargement and implantation of a larger prosthesis is traditionally employed; however, this approach involves the risks of morbidity and mortality of redo surgery, which may be prohibitive in critically ill or medically complex patients. Bioprosthetic valve fracture (BVF), where high-pressure balloon inflation is employed to fracture the surgical valve sewing ring to increase the EOA, has been used as an adjunct for valve-in-valve (transcatheter aortic valve in surgical aortic valve [TAV in SAV]) procedures for degenerated surgical valves to increase EOA, but has not yet been reported as standalone therapy for early PPM after SAVR.We present a case of a 41-year-old male (body surface area, 2.3 m²) who presented 4 months after SAVR with a 21 mm surgical valve (Magna Ease, true inner diameter, 19 mm) with severe PPM (mean gradient, 43 mm Hg) despite normal functioning valvular prosthetic leaflets, associated with debilitating symptoms. This patient was deemed high risk by the heart team, and was successfully treated with TAV in SAV (26 mm Evolut R) and concomitant high-pressure bioprosthetic valve fracture (BVF) with a 22 mm high-pressure balloon. The patient tolerated the procedure well; mean gradient was 5 mm Hg post BVF and prompt resolution of symptoms was seen. His postprocedure recovery was uneventful and his symptoms resolved, allowing him to return to work within a week of his hospital discharge. BVF associated with TAV in SAV appears to be a feasible approach for treatment of severe symptomatic PPM even in the early postoperative period with otherwise normally functioning prosthesis.

Canine thyroid tumours are uncommon and the majority of tumours are carcinomas or adenomas, with only very few mixed tumours or metastases from distant sites described to date. A primary thyroid haemangiosarcoma has never been reported in veterinary medicine. In this case report, we describe a dog with a history of a large, non-painful, mobile ventral neck mass in the right paralaryngeal region. CT and ultrasound-guided fine needle aspirates were used for clinical staging. The mass was surgically excised and histopathological examination indicated a haemangiosarcoma. Abdominal ultrasound revealed the presence of splenic nodules and splenectomy indicated the presence of haemangiosarcoma. Chemotherapy with doxorubicin was started, but the dog was euthanased after three rounds of therapy, 97 days after the mass was discovered.

In patients with increased surgical risk and hemodynamically significant mitral disease, a transcatheter strategy for mitral valve replacement (TMVR) may be suitable; however, is also not without procedure risk. Obstruction of the left ventricular outflow tract (LVOT) is one of the most dreaded complications of TMVR, requiring careful consideration of potential candidates with preprocedural imaging and ex vivo valvular fit simulation as part of risk assessment for postprocedure obstruction. In patients at high risk of LVOT obstruction, early studies have shown that alcohol septal ablation or electrosurgical laceration of the anterior mitral leaflet (LAMPOON) procedure prior to TMVR may mitigate the risk of LVOT obstruction. We describe the recent successful management of a patient with severe mitral valve disease, mitral annular calcification (MAC), and high risk of post-TMVR LVOT obstruction, who underwent a sequential strategy of ASA followed by electrosurgical leaflet resection with the LAMPOON procedure prior to TMVR to successfully prevent LVOT obstruction. To our knowledge, this is the first time this dual strategy has been reported, and it may allow more patients with severe mitral valve disease to undergo TMVR in the future.

Transcatheter aortic valve replacement (TAVR) has been widely adopted, but outcomes in end-stage renal disease (ESRD) patients on hemodialysis (HD) have not been extensively studied.A total of 1260 TAVRs were performed at our center between December 2011 and October 2018, including 86 patients (6.82%) with ESRD on HD. Comparisons were made between baseline demographics, preoperative risk, hemodynamics, and reintervention, as well as survival at 30 days, 1 year, and 2 years.Age at TAVR was 62.7 ± 12.1 years in the ESRD-HD group vs 72.3 ± 5.9 years in the non-ESRD group (P.01). STS scores were 10.2 ± 1.3% in the ESRD-HD group vs 8.1 ± 1.1% in the non-ESRD group (P.01). Mortality rates were different between the ESRD-HD group and the non-ESRD group (30-day mortality, 5.8% vs 3.1%, respectively [P=.05]; 1-year mortality, 25.1% vs 13.6%, respectively [P.01]; 2-year mortality, 51.6% vs 23.0%, respectively [P.01]). Baseline aortic valve areas (AVAs) were comparable; however, ESRD-HD patients had higher gradients than non-ESRD patients at every postprocedural interval assessed (30-day AVA, 1.47 ± 0.2 cm² vs 1.32 ± 0.1 cm², respectively [P.001]; 1-year AVA, 1.39 ± 0.1 cm² vs 1.05 ± 0.1 cm², respectively [P.01]; 2-year AVA, 1.28 ± 0.1 cm² vs 0.77 ± 0.05 cm² , respectively [P.01]). Repeat TAVR was needed within 2 years in 5 ESRD-HD patients (6.8%) and 1 non-ESRD patient (0.01%).In our single-center cohort, the ESRD-HD TAVR group demonstrated significantly higher rates of need for valvular reintervention (6.8% vs 0.01%) at 2 years, as well as higher mortality rates at 30 days, 1 year, and 2 years.

Background Cangrelor, an intravenous, reversible P2Y12 antagonist, is approved for use in patients undergoing percutaneous coronary intervention (PCI). Objectives This study sought to evaluate the efficacy and safety of cangrelor compared with clopidogrel in subgroups that did and did not receive glycoprotein IIb/IIIa inhibitors (GPIs). Methods This pooled, patient-level analysis of the 3 CHAMPION (Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition) trials analyzed all randomized patients who underwent PCI and received the study drug (n = 24,902). Only bailout/rescue GPI use was permitted, except in CHAMPION PCI, in which routine or bailout/rescue GPI use was at the site investigator’s discretion. The primary efficacy endpoint was the composite of all-cause mortality, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 h after randomization. Results Overall, 3,173 patients (12.7%) received a GPI, most commonly eptifibatide (69.4%). Despite variation in indications for GPIs, baseline characteristics were well balanced between the cangrelor and clopidogrel arms in subsets receiving and not receiving GPIs. Rates of the primary composite endpoint were lower with cangrelor compared with clopidogrel in patients who did (4.9% vs. 6.5%; odds ratio [OR]: 0.74; 95% confidence interval [CI]: 0.55 to 1.01) or did not receive a GPI (3.6% vs. 4.4%; OR: 0.82; 95% CI: 0.72 to 0.94; Pint = 0.55). Cangrelor did not increase the primary safety endpoint, GUSTO-defined severe/life-threatening bleeding, in patients who did (0.4% vs. 0.5%; OR: 0.71; 95% CI: 0.25 to 1.99) or did not receive GPIs (0.2% vs. 0.1%; OR: 1.56; 95% CI: 0.80 to 3.04; Pint = 0.21). GPI use was associated with increased risk of bleeding in both treatment arms. Conclusions Cangrelor’s efficacy in reducing ischemic complications in patients undergoing PCI was maintained irrespective of GPI administration. GPI use was associated with substantially higher bleeding rates, regardless of the randomization to cangrelor or clopidogrel. (A Clinical Trial to Demonstrate the Efficacy of Cangrelor [PCI]: NCT00305162 ; Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition [PLATFORM]: NCT00385138 ; A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI] [CHAMPION PHOENIX] [CHAMPION]: NCT01156571 )

Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP).This study evaluated the safety and efficacy of TCEP during TAVR.Nineteen centers randomized 363 patients undergoing TAVR to a safety arm (n = 123), device imaging (n = 121), and control imaging (n = 119). The primary safety endpoint consisted of major adverse cardiac and cerebrovascular events (MACCE) at 30 days, and the primary efficacy endpoint was reduction in new lesion volume in protected brain territories on magnetic resonance imaging scans at 2 to 7 days. Patients underwent neurocognitive assessments, and the debris captured was analyzed.The rate of MACCE (7.3%) was noninferior to the performance goal (18.3%, pTCEP was safe, captured embolic debris in 99% of patients, and did not change neurocognitive function. Reduction in new lesion volume on magnetic resonance scans was not statistically significant. (Cerebral Protection in Transcatheter Aortic Valve Replacement [SENTINEL]; NCT02214277).

Percutaneous approaches have become routine in transcatheter aortic valve replacement (TAVR). Despite numerous advantages, vascular complications associated with percutaneous access can occur during and after TAVR, and increase morbidity and mortality significantly. Effective management of potentially catastrophic vascular complications often requires prompt recognition, diagnosis, and management by multidisciplinary teams.

I have to confess that it was with some trepidation that, in 2005 at the start of my function as President of the newly instituted, and now already defunct, European Union Civil Service Tribunal in Luxembourg, I awaited the appointment that was to be set up with Carl Baudenbacher in order to explore the possibility of organising a working meeting between our small Tribunal and his EFTA Court. Who was this man, I wondered, who could take on the job of succeeding the mythical and monumental Icelander, Thor Vilhjalmsson as President of the EFTA Court? When, very soon after my arrival in Luxembourg, I did meet Carl, at an official dinner of the EFTA Court, I discovered the congenial, cultured and dynamic reality of “this man”. What followed was a still continuing history of family friendship. This modest article on one aspect of judicial reasoning—namely, whether the acceptability of a court’s ruling should enter into the decision-making process of judges—is dedicated to Carl in thanks for that friendship, as well as being an expression of respect for his professional achievements.

Transcatheter Aortic Valve Replacement (TAVR) has evolved as a strategy for managing aortic stenosis in a growing proportion of patients considered at high or intermediate surgical risk. Though early data has demonstrated excellent durability and life span of transcatheter valves up to five years, there is an absence of case based studies in the literature regarding transcatheter valve failure after TAVR, and outcomes of subsequent redo TAVR Valve-in-Valve (VIV) procedures. We report here a successful case of emergent, catheter-based treatment for severe, highly symptomatic valve in valve restenosis of a 5 year old Sapien valve.

Transcatheter mitral valve-in-valve (TMVIV) or valve-in-ring (TMVIR) replacement has shown early promise in patients deemed poor surgical candidates as a less invasive alternative to conventional reoperative mitral valve (MV) replacement.This retrospective, single-center study reviewed the procedural outcomes of all TMVIV and TMVIR procedures between 2013-2018 at a large tertiary referral center serving the southeastern United States. An analysis of patient safety measures was also performed, with a retrospective assessment of relative procedural safety that included preoperative risk stratification and postoperative mortality predictors, operative time, average blood loss, length of hospital stay, and readmission rates.This study included 24 patients with severe MV disease and medical comorbidities who were considered too high risk for conventional MV replacement. All patients underwent TMVIV or TMVIR with Edwards Sapien XT or S3 transcatheter valves (Edwards Lifesciences). A secure database of patient demographics, preoperative risk assessment, and procedural data was created and included technical success rates, blood loss, operative time, and intraoperative and immediate postoperative complications. Subsequent follow-up of patient outcomes reported here include those collected at 30 days, 180 days, and 1 year.Of the 24 patients in our study, 16 received TMVIV and 8 received TMVIR implantation. Each procedure was performed successfully under general anesthesia via transseptal approach (n = 17) or transapical approach (n = 7), with only 1 patient (8.2%) requiring late operative reintervention 252 days post op. Average procedural time was 76 min and average blood loss was75 mL, with 20/24 patients (83%) successfully extubated on postoperative day 0. Length of Intensive Care Unit stay was 1.7 ± 1.4 days and length of total inpatient stay was 2.8 ± 1.8 days. Echocardiograms were collected immediately post op, at 30 days, at 180 days, and subsequently at yearly intervals; follow-up demonstrated excellent prosthetic valve function with low transvalvular gradients, and no evidence of valve embolization or thrombosis. In patients with follow-up data available at 1 year (n = 13), there were no readmissions at 30 days or 180 days, and only 1 admission (8.3%) during the first postoperative year for symptoms related to congestive heart failure (CHF).TMVIV and TMVIR can be safe and effective in a patient population considered at prohibitive risk for conventional surgery. These procedures can be performed efficiently in a hybrid operating room, with relatively short procedural times and high rates of early extubation. Procedural complications, mortality, and readmission rates for CHF at 30 days, 180 days, and 1 year were very low in this high-risk cohort.

The incidence of transcatheter aortic valve replacement (TAVR) graft dysfunction and valvular restenosis has not been well characterized in end-stage renal disease (ESRD) patients beyond the first post-operative year. This study sought to undertake a retrospective assessment of longitudinal outcome

Vascular complications remain a significant technical challenge for transfemoral TAVR (transcatheter aortic valve replacement). The goal of this study is to develop a preoperative tool for prediction of major vascular complications of TAVR.A retrospective review was performed of all patients who underwent transfemoral TAVR at a tertiary medical center from 2011 to 2015. Iliofemoral arterial measurements were obtained with computed tomography angiography three-dimensional reconstruction images and an Iliac Morphology Score (IMS) was created from these measurements. Vascular complications were defined by Valve Academic Research Consortium (VARC-2) criteria. Statistical analyses were performed utilizing chi-squared test, Student's t-test, and binomial regression.We analyzed the data of 198 transfemoral TAVR patients. VARC-2 vascular complications were seen in 25 patients (13%). Major and minor vascular complication rates in the entire cohort were 4% (n = 7) and 9% (n = 18), respectively. Thirty-one patients (15.6%) required vascular surgery consultation. A total of 24 patients (12%) required surgical or percutaneous vascular interventions. Univariate analysis identified gender, iliac diameter, iliac calcification, and access type (open versus percutaneous) as predictors of major complications. The IMS was composed of ipsilateral minimum iliac diameter and iliac calcifications based on area under the receiver operator curve (AUROC) analysis (P 0.05, AUROC = 0.82). Arterial size and calcification were classified with a value of 0-3 based on severity. Multivariate analysis identified gender and IMS as independent predictors of major complications. The mean IMS for the cohort was 3.4 (range 0-6). Patients were divided into high (IMS ≥ 5, n = 55) and low risk (IMS5, n = 143) groups based on the inflection point for specificity (73%) and sensitivity (83%). The high-risk group had smaller iliac diameters, areas, luminal volumes, and a higher rate of major vascular complications (9% vs. 1%, P = 0.001). The 30-day mortality rate in the high score group was 9% and 1.4% in low score group (P = 0.02, AUROC = 0.72).An IMS composed of ipsilateral minimum iliac diameter plus iliac calcification is an excellent predictor of major vascular complications and mortality. Alternative access in patients with high IMS may reduce major vascular complications and 30-day mortality.

Evaluating a series of thoracic radiographs may be one of the most challenging imaging tasks confronting the small animal clinicians in their daily practice. Pathological changes can sometimes be quite subtle, while at other times they can be confusing in their complexity. Radiographs that are not of optimal quality only add to this confusion, either by hiding pathological changes or creating artifacts that resemble pathology. In the ideal world, every thoracic radiograph would be perfect and the clinician9s task would be easier. In the real world, patients with intrathoracic disease can be high risk and difficult to position, and a balance needs to be struck between patient safety and diagnostic quality. This article describes how to get the most out of thoracic radiographs by improving the diagnostic quality of radiographic films.

Extramural studies (EMS) are compulsory for all veterinary students in the UK. The benefits of a strong EMS programme are considerable, and have been clearly set out by the RCVS in its EMS recommendations, policy and guidance notes. Although universities take primary responsibility for delivering ‘Day 1 competencies’ for students, EMS placements provide the ‘real world’ environment in which undergraduates can develop their practical skills further and continue to build the professional skills essential for a successful career. Here, Paul Mahoney and Nicola Martin outline how the Royal Veterinary College and the People's Dispensary for Sick Animals are working together to ensure that students get the most from their EMS placements.

Bilateral transpalpebral ultrasonography was performed on 53 captive Asian elephants (Elephas maximus) in order to describe the normal ultrasonographic appearance and measurements of the Asian elephant eye. Transpalpebral ultrasonography was performed using a portable ultrasound unit and a 4-7-MHz broadband curvilinear transducer on animals housed at seven institutions in the United Kingdom and in Sri Lanka. Both males and females were included in the study and ages ranged from 14 mo to 65 yr. Ultrasonic examinations were conducted on unsedated animals, without the use of topical or local anesthesia. The ultrasonographic appearance of the globe and intraocular structures of the Asian elephant eye is similar to that in other species. Biometry measurements recorded for adult (n=41) and juvenile (n=10) Asian elephants were: axial length, 3.44 +/- 0.21 cm and 3.18 +/- 0.19 cm (mean +/- SD); equatorial diameter, 3.88 +/- 0.32 cm and 3.60 +/- 0.24 cm; corneal thickness, 0.17 +/- 0.02 cm and 0.16 +/- 0.02 cm; anterior segment depth, 0.45 +/- 0.08 cm and 0.36 +/- 0.07 cm; lens diameter, 1.90 +/- 0.14 cm and 1.75 +/- 0.19 cm; lens depth, 1.01 +/- 0.12 cm and 0.94 +/- 0.10 cm, and posterior segment depth, 1.82 +/- 0.17 cm and 1.72 +/- 0.15 cm, respectively. Multiple linear regression analysis indicated a significant relationship between the explanatory variables (age, sex, and height) and the dependent variables (axial length, equatorial diameter, corneal thickness, anterior segment depth, lens diameter, and lens depth). The main finding of this statistical test was that the globe increases in size as the animal ages. Transpalpebral ultrasonography was found to be an effective and practical imaging modality in the evaluation of the Asian elephant eye, without the need for chemical restraint.

Σκοπός της αναδρομικής αυτής μeλέτης eίναι η διeρeύνηση της eυαισθησίας, eιδικότητας και ακρίβeιας των απeικονιστικών μeθόδων που χρησιμοποιούνται για τη διάγνωση του έκτοπου ουρητήρα στο σκύλο. Μeλeτήθηκe αρχeιακό υλικό του νοσοκομeίου ζώων Queen Mother Hospital for animals του Royal Veterinary College της Μeγάλης Βρeτανίας από το Νοέμβριο του 1995 μέχρι τον Ιανουάριο του 2006. Μόνο σκύλοι μe τουλάχιστον μία ακτινολογική μeλέτη μe χρήση σκιαγραφικής ουσίας, υπeρηχογραφική eξέταση, eξέταση των ουρητήρων και χeιρουργική διάγνωση συμπeριeλήφθησαν. Πραγματοποιήθηκe συγκριτική αξιολόγηση της eνδοφλέβιας ουρογραφίας (EΟ), παλλίνδρομης ουρογραφίας (ΠΟ), υπeρηχογραφικής eξέτασης (ΥΠΟ) και χeιρουργικής διάγνωσης. Όλα τα πeριστατικά αξιολογήθηκαν ανά ουρητήρα ξeχωριστά, αλλά και μe βάση το πeριστατικό συνολικά ανeξάρτητα από την απόληξη του κάθe ουρητήρα. Η ΥΠΟ βρέθηκe να έχeι την υψηλότeρη eυαισθησία, eιδικότητα και ακρίβeια ανά πeριστατικό και μe βάση την τeλική διάγνωση, eνώ η EΟ eίχe υψηλότeρη eυαισθησία στην ανάλυση ανά ουρητήρα. Το κυριότeρο μeιονέκτημα της ΥΠΟ eίναι η μη eντόπιση της σωστής θέσης του έκτοπου ουρητήρα. Όταν η ανάλυση πραγματοποιήθηκe μe βάση την τeλική διάγνωση του πeριστατικού και ανeξάρτητα από την απόληξη του κάθe ουρητήρα, η ΥΠΟ eίχe τέλeια eυαισθησία, eιδικότητα και ακρίβeια. Η χαμηλότeρη eιδικότητα και ακρίβeια των μeθόδων EΟ και ΠΟ φαίνeται να σχeτίζeται μe τη δυσκολία αναγνώρισης της θέσης απόληξης των ουρητήρων.

Objective: To assess the usefulness of computed tomography arthrography of the stifle in diagnosing meniscal tears in dogs with cranial cruciate ligament insufficiency. Methods: A prospective clinical study was performed. Dogs were included if they had evidence of cranial cruciate ligament insufficiency or persistent or recurrent lameness following surgery for cranial cruciate ligament insufficiency. Dogs were sedated for a computed tomography scan of the affected stifle, orientated in the dorsal plane. A survey computed tomography scan was followed by a computed tomography arthrogram. A stifle arthrotomy was performed, and the surgical findings were recorded. The computed tomography scans were reviewed by three blinded reviewers, and the results were compared to the surgical findings. Results: Twenty-one computed tomography arthrograms from 20 dogs were included. At surgery, damage to the medial meniscus was identified in 14 stifles. Initial interpretation of computed tomography arthrography images was 57 to 64 per cent sensitive and 71 to 100 per cent specific for diagnosing medial meniscal injuries. Interpretation of the images on retrospective analysis was 71 per cent sensitive and 100 per cent specific, with an accuracy of 0·857. Clinical Significance: The accuracy of stifle computed tomography arthrography for the diagnosis of tears to the medial meniscus was found to be good. It is a minimally invasive and repeatable technique, which does not require general anaesthesia or specialist training to obtain the images. The ability to reliably diagnose meniscal injury without the need for surgery may be advantageous, particularly in dogs which had previously had surgery for cranial cruciate ligament insufficiency.

A multicenter trial has established the antifracture efficacy of oral daily (2.5mg) as well as intermittent (20mg every other day for 12 doses every 3mo) ibandronate in women with postmenopausal osteoporosis. As diagnostic spinal radiographs for this trial were read at 2 centers, the study protocol included rigorous procedures for diagnosis of morphometric vertebral fractures. These included standardized qualitative and morphometric assessment methods for diagnosing vertebral osteoporotic fractures and consensus cross-validation procedures for maximizing fracture diagnostic accuracy and consistency between the 2 radiographic reading centers. Using these stringent measures, the between-center discrepancy in the diagnosis of prevalent fractures was only 8%. Furthermore, after cross-validation, discrepancy in the final diagnosis of incident fractures between centers was found for only 4 patients, resulting in a net gain of only 2 fractures in the trial. This meticulous methodology provided a highly effective means of identifying vertebral fractures and recruiting the trial population in which to assess the efficacy of ibandronate in postmenopausal osteoporosis.

Objective - To investigate the use of computed tomography (CT) arthrography in cadaveric canine stifles with particular emphasis on the diagnosis of meniscal injury. Study Design - Prospective cadaver study. Sample Population - Pelvic limbs from adult Beagles (n=10). Methods - After survey CT scan of each stifle oriented in the dorsal plane, positive contrast stifle CT arthrogram (CTA) was performed using the same slice orientation. Each stifle was then randomly allocated into 1 of 2 treatment groups: group A-arthrotomy, cranial cruciate ligament (CCL) transection and simulated injury to the caudal horn of the medial meniscus; group B-arthrotomy and CCL transection only. CT scan was repeated as before and post-arthrotomy images were interpreted by a radiologist unaware of treatment grouping. Results - The cranial and caudal cruciate ligaments, medial and lateral menisci, menisco-femoral ligament, and long digital extensor tendon were all identifiable on CTA images. CTA was 90% sensitive and 100% specific for diagnosing simulated caudal horn meniscal injury. Conclusions - Stifle CTA enables identification of intra-articular structures within the stifle and is a reliable method for identifying simulated meniscal injuries in a cadaver model. Clinical Relevance - CTA imaging of the canine stifle has potential clinical value for detection of meniscal injury. (c) Copyright 2008 by The American College of Veterinary Surgeons.