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The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective study for valve-in-mitral annular calcification (ViMAC), mitral valve-in-ring (MViR), and mitral valve-in-valve (MViV) using balloon-expandable aortic transcatheter heart valves. Procedural outcomes beyond 1 year are not well described.This study evaluated 2-year outcomes in ViMAC, MViR, and MViV in the MITRAL trial.This multicenter prospective study enrolled patients with severe MAC, prior failed mitral annuloplasty ring repair, or prior failed bioprosthetic MV replacement who were at high surgical risk at 13 U.S. sites.Between February 1, 2015, and December 31, 2017, 91 patients were enrolled (31 with ViMAC, 30 with MViR, and 30 with MViV). In the ViMAC group, 2-year all-cause mortality was 39.3%, 66.7% were New York Heart Association (NYHA) functional class I-II, and mean MV gradient was 5.6 ± 2.0 mm Hg. In the MViR group, 2-year all-cause mortality was 50%, 65% were NYHA functional class I-II, and mean MV gradient was 6.5 ± 2.7 mm Hg. In the MViV group, 2-year all-cause mortality was 6.7%, 85% were NYHA functional class I-II, and mean MV gradient was 6.9 ± 2.4 mm Hg. At 2 years, all patients had ≤mild mitral regurgitation and survivors in all 3 arms showed sustained improvement in Kansas City Cardiomyopathy Questionnaire scores compared to baseline.Use of balloon-expandable aortic transcatheter heart valves in selected patients with severe MAC, failed annuloplasty ring, and bioprosthetic MV dysfunction is associated with improvements in symptoms, quality of life, and stable prosthesis function at 2-year follow-up. Between 1 and 2 years, the MViR group experienced higher mortality rates than the MViV and ViMAC groups.

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.

CuAlNi shape memory alloy (SMA) has wide scope in vibration damping applications for machine tools. A bespoke cold spray based additive manufacturing system was used to fabricate CuAlNi SMA precursor structures of two different compositions with optimized deposition parameters, which were subsequently alloyed via annealing. The two compositions of CuAlNi chosen for the study were Cu rich in wt% (Cu-82%, Al-14%, Ni-4%) and the Ni rich in wt% (Cu-12%, Al-2%, Ni-80%) shape memory alloy material. The various properties of developed samples were compared with commercially available CuAlNi structure. The properties compared include surface morphology, crystal structure, phase transformation temperature, and mechanical properties were studied with scanning electron microscopy (SEM), X-ray diffraction (XRD), differential scanning calorimetry (DSC) compression testing respectively. The shape memory characteristics were also analyzed using dynamic mechanical analyzer (DMA). Among the two samples, Cu rich sample exhibited better SMA qualities than Ni rich sample as reported in the literature. The micro-hardness of Cu rich sample was to be 356 ± 3 VHN comparatively lower than Ni rich sample. The DSC results revealed the phase transformation hysteresis for Cu rich sample to be very low at 5 ± 3°C. The Cu rich CuAlNi SMA showed very good shape memory characteristics in the DMA results in the range of 50°C to 100°C.

The timing of hemodynamic support in acute myocardial infarction complicated by cardiogenic shock (AMICS) has yet to be defined. The aim of this meta-analysis was to evaluate the impact of timing of Impella initiation on early and midterm mortality.A systematic literature review and meta-analysis was conducted using PubMed and Cochrane databases. All studies reporting short-term mortality rates and timing of Impella placement in AMICS were included. Meta-regression analysis and sensitivity analysis were performed on the primary endpoint, short-term mortality (≤30 days), and secondary endpoints (midterm mortality, device-related bleeding, and limb ischemia).Of 1289 studies identified, 13 studies (6810 patients; 2970 patients identified as receiving Impella pre-PCI and 3840 patients receiving Impella during/post-PCI) were included in this analysis. Median age was 63.8 years (IQR 63-65.7); 76% of patients were male, and a high prevalence of cardiovascular risk factors was noted across the entire population. Short-term mortality was significantly reduced in those receiving pre-PCI vs. during/post-PCI Impella support (37.2% vs 53.6%, RR 0.7; CI 0.56-0.88). Midterm mortality was also lower in the pre-PCI Impella group (47.9% vs 73%, RR 0.81; CI 0.68-0.97). The rate of device-related bleeding (RR 1.05; CI 0.47-2.33) and limb ischemia (RR 1.6; CI 0.63-2.15) were similar between the two groups.This analysis suggests that Impella placement prior to PCI in AMICS may have a positive impact on short- and midterm mortality compared with post-PCI, with similar safety outcomes. Due to the observational nature of the included studies, further studies are needed to confirm this hypothesis (CRD42022300372).

Patients presenting with acute myocardial infarction complicated by cardiogenic shock (AMI-CS) are at high risk for impaired antiplatelet activity secondary to malabsorption, systemic hypoperfusion, hypothermia, need for mechanical ventilation, and high use of analgesics. The use of antiplatelet therapy in these high-risk patients is not well studied.Using the National Cardiogenic Shock Initiative database, we analyzed patients who presented with AMI-CS at 60 hospitals from March 2018 to December 2020. All patients were treated using a standard shock protocol. Herein, the patterns of antiplatelet use are described.A total of 204 patients were included in the analysis, of which 174 (85.3%) presented with ST-segment elevation myocardial infarction (STEMI). The majority (84.3%) received antiplatelet therapy before percutaneous coronary intervention (PCI); of those who received antiplatelets, 77.9% received aspirin, 55.2% received an oral P2Y12 inhibitor, and 19.2% received intravenous (IV) antiplatelet therapy. Ticagrelor was the most common P2Y12 inhibitor administered (41.9%), followed by clopidogrel (12.2%) and prasugrel (1.2%). Only 18.6% of oral antiplatelet agents were crushed. Baseline characteristics of patients who received IV vs non-IV antiplatelet agents were similar. Thrombolysis in Myocardial Infarction (TIMI) 0 flow was present in 69.6% of patients before PCI and aspiration thrombectomy was performed in 24.5% of patients. The presence of STEMI, cardiac arrest, cardiopulmonary resuscitation, hypothermia, vasopressor use, elevated lactate levels, or number of vessels treated did not influence the use of IV antiplatelet agents.The use of crushed and IV antiplatelet agents in AMI-CS is low. Further studies are needed in this high-risk population to assess whether more potent antiplatelet inhibition will improve outcomes.

Mechanical circulatory support (MCS) devices are increasingly used for hemodynamic support in cardiogenic shock or high-risk percutaneous coronary interventions. Vascular complications remain a major source of morbidity and mortality despite technological advances with percutaneous techniques. Little is known about the rates and predictors of vascular complications with large-bore access MCS in the contemporary era.The study cohort was derived from National Inpatient Sample using data from 2015 to 2019 for cardiac hospitalizations with the use of: intra-aortic balloon pump (IABP) Impella, and/or extracorporeal membrane oxygenation (ECMO). The rates of vascular complications and in-hospital outcomes were analyzed using multivariable logistic regression.Of 221,700 hospitalizations with MCS use, the majority had only IABP (68%). The rates of vascular complications were greatest with ECMO (15.8%) when compared with IABP (3.0%) and Impella (5.6%). Among patients with vascular complications, in-hospital mortality was higher with ECMO (56.3%) when compared with IABP (26.2%) and Impella (33.8%). Peripheral arterial disease (PAD) was the strongest predictor of vascular complications, with 10 times higher odds when present (adjusted odds ratio [aOR] 10.96, p 0.001). In risk-adjusted models, when compared with IABP, the use of Impella (aOR: 1.73, p 0.001), ECMO (aOR: 5.35, p 0.001), or a combination of MCS devices (aOR: 3.47, p 0.001) was associated with higher odds of vascular complications.In contemporary practice, the use of MCS is associated with significant vascular complications and in-hospital mortality. Predictors of vascular complications include larger arteriotomy size, female gender, and peripheral arterial disease. Vascular access management remains essential to prevent major complications.

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.

This paper describes the use of Supersonic Laser Deposition (SLD) to manufacture nickel/graphite composite coatings on titanium and aluminium substrates. Laser heating is critical for depositing coatings containing up to 13.3 vol% graphite. For a given feedstock composition, the resulting graphite content and average size of the graphite particles retained in the coating increases with laser power, until substrate melting occurs. The effect of the powder type, feedstock composition, and process conditions on coating structure is characterized. The friction and wear behaviour of selected coating compositions is examined. Nickel coatings containing 13.3 vol% graphite demonstrated self-lubricating behaviour with a stable coefficient of friction below 0.14 in pin-on-disc testing.

Cardiogenic shock (CS) is associated with significant morbidity and mortality. Differentiating the etiologic factors driving CS has epidemiological significance and aids in optimization of therapeutic strategies, prognostication, and resource utilization. The aim herein is to investigate the epidemiology and clinical outcomes of CS in those with ischemic and nonischemic CS etiologies. Using International Classification of Diseases codes, we queried the national inpatient sample for CS hospitalization from 2007 to 2018 and divided the study sample into cohorts of ischemic (I-CS) and nonischemic cardiogenic shock (NI-CS). We then compared the primary outcome of in-hospital mortality between these 2 cohorts. Two groups of secondary outcomes (clinical and procedural) were also assessed between the 2 cohorts. CS was present in 557,860 hospitalizations; 84% of these were I-CS and 15.8% NI-CS. Patients with I-CS were older, more commonly males, with more risk factors for coronary artery disease (P0.05). NI-CS had higher prevalence of preexisting systolic heart failure and atrial fibrillation. The in-hospital mortality was significantly higher in patients with I-CS (32.2% vs. 29.5%, adjusted odds ratio 1.10, P0.001). Frequencies of acute ischemic stroke, mechanical ventilation, ventricular arrhythmias, and vascular complications were higher in I-CS versus NI-CS, while acute kidney injury and acute liver failure were more common in NI-CS (P0.05). The use of mechanical circulatory support devices was higher in the I-CS group. In conclusion, patients with I-CS comprise the vast majority of CS and are associated with higher mortality and higher resource utilization. Conversely, patients with NI-CS appear to have higher survival but with a higher prevalence of end-organ dysfunction.

To assess the impact of pulmonary hypertension (PH) on outcomes of patients with severe mitral annular calcification (MAC) undergoing transcatheter mitral valve replacement (TMVR).PH is associated with poor outcomes after mitral valve surgery. Whether the presence of PH in patients with MAC undergoing (TMVR) is associated with poor outcomes, is unknown.Retrospective evaluation of 116 patients from 51 centers in 11 countries who underwent TMVR with valve in mitral annular calcification (ViMAC) using balloon-expandable aortic transcatheter valves (THVs) from September 2012 to March 2017. Pulmonary artery systolic blood pressure (PASP) by echocardiogram was available in 90 patients. The subjects were stratified based on PASP: No PH = PASP ≤35 mmHg (n = 11); mild to moderate PH = PASP 36-49 mmHg (n = 21) and severe PH = PASP ≥50 mmHg (n = 58). Clinical, procedural, and echocardiographic outcomes were assessed.Mean age was 72.7 (±12.8) years, 59 (65.6%) were female, Society of Thoracic Surgeons score was 15.8 + 11.8% and 90.0% where in New York Heart Association (NYHA) class III-IV. There was no significant difference in all-cause mortality at 30 days (no PH = 27.3%, mild-moderate PH = 19.0%, severe PH = 31.6%; p = 0.55) or at 1 year (no PH = 54.5%, mild-moderate PH = 38.1%, severe PH = 56.1%; p = 0.36). No difference in adverse events, NYHA class or amount of residual mitral regurgitation at 1 year were observed between the groups.This study suggests that the presence of PH in patients with predominantly mitral stenosis with MAC undergoing TMVR does not impact mortality or adverse events. Further studies are needed to fully understand the effect of PH in this group of patients.

Several studies have pair-wise compared access sites for transcatheter aortic valve replacement (TAVR) but pooled estimate of overall comparative efficacy and safety outcomes are not well known. We sought to compare short- and long-term outcomes following various alternative access routes for TAVR.Thirty-four studies with a pooled sample size of 32,756 patients were selected by searching PubMed and Cochrane library databases from inception through 11th June 2021 for patients undergoing TAVR via 1 of 6 different access sites: Transfemoral (TF), Transaortic (TAO), Transapical (TA), Transcarotid (TC), Transaxillary/Subclavian (TSA), and Transcaval (TCV). Data were extracted to conduct a frequentist network meta-analysis with a random-effects model using TF access as a reference group.Compared with TF, both TAO [RR 1.91, 95% CI (1.46-2.50)] and TA access [RR 2.12, 95% CI (1.84-2.46)] were associated with an increased risk of 30-day mortality. No significant difference was observed for stroke, myocardial infarction, major bleeding, conversion to open surgery, and major adverse cardiovascular or cerebrovascular events at 30 days between different accesses. Major vascular complications were lower in TA [RR 0.43, (95% CI, 0.28-0.67)] and TC [RR 0.51, 95% CI (0.35-0.73)] access compared to TF. The 1-year mortality was higher in TAO [RR of 1.35, (95% CI, 1.01-1.81)] and TA [RR 1.44, (95% CI, 1.14-1.81)] groups.Non-thoracic alternative access site utilization for TAVR implantation (TC, TSA and TCV) is associated with outcomes similar to conventional TF access. Thoracic TAVR access (TAO and TA) translates into increased short and long-term mortality.

This study sought to evaluate the differences in cardiogenic shock patient characteristics in trial patients and real-life patients.Cardiogenic shock (CS) is a leading cause of mortality in patients presenting with acute myocardial infarction (AMI). However, the enrollment of patients into clinical trials is challenging and may not be representative of real-world patients.We performed a systematic review of studies in patients presenting with AMI-related CS and compared patient characteristics of those enrolled into randomized controlled trials (RCTs) with those in registries.We included 14 RCTs (n = 2,154) and 12 registries (n = 133,617). RCTs included more men (73% vs 67.7%, P 0.001) compared with registries. Patients enrolled in RCTs had fewer comorbidities, including less hypertension (61.6% vs 65.9%, P 0.001), dyslipidemia (36.4% vs 53.6%, P 0.001), a history of stroke or transient ischemic attack (7.1% vs 10.7%, P 0.001), and prior coronary artery bypass graft surgery (5.4% vs 7.5%, P 0.001). Patients enrolled in RCTs also had lower lactate levels (4.7 ± 2.3 mmol/L vs 5.9 ± 1.9 mmol/L, P 0.001) and higher mean arterial pressure (73.0 ± 8.8 mm Hg vs 62.5 ± 12.2 mm Hg, P 0.001). Percutaneous coronary intervention (97.5% vs 58.4%, P 0.001) and extracorporeal membrane oxygenation (11.6% vs 3.4%, P 0.001) were used more often in RCTs. The in-hospital mortality (23.9% vs 38.4%, P 0.001) and 30-day mortality (39.9% vs 45.9%, P 0.001) were lower in RCT patients.RCTs in AMI-related CS tend to enroll fewer women and lower-risk patients compared with registries. Patients enrolled in RCTs are more likely to receive aggressive treatment with percutaneous coronary intervention and extracorporeal membrane oxygenation and have lower in-hospital and 30-day mortality.

Supersonic Laser Deposition (SLD) is a coating and fabrication process combining cold spray (CS) with laser heating of the deposition zone. Laser heating increases deformation on impact, improving bonding for a given particle velocity, eliminating the need to use helium while retaining the advantages of CS; solid-state deposition, low oxidation and high build rate (≤ 10 kg/hr). Although solid lubricants offer advantages over liquid lubrication, remaining effective over a wide range of operating temperatures and loads, while simplifying sealing, their use is limited by current application methods. SLD enables the deposition of metallic coatings which incorporate solid lubricants into metallic coatings, onto a range of substrates. This paper details the powders and conditions used to deposit nickel/graphite using SLD, and the structure and tribological properties of the coatings produced. Co-efficients of friction below 0.14 were demonstrated for nickel/graphite coatings on aluminium substrates.

We report herein Rhodococcus equi infection in an 11-y-old, male llama with a history of diarrhea and endoparasitism. Postmortem examination revealed granulomatous and ulcerative enteritis, pyogranulomatous mesenteric lymphadenitis, fibrinosuppurative peritonitis, and granulomatous hepatitis. Intralesional macrophages were laden with gram-positive cocci. Bacteriology identified R. equi, and cultures tested positive for R. equi choE and vapA genes by PCR. This case expands the reported spectrum of lesions associated with R. equi infections in llamas from pyogranulomatous bronchopneumonia and peripheral lymphadenitis to pyogranulomatous mesenteric lymphadenitis and enteritis. We also link a R. equi that is carrying the virulent-associated protein gene VapA to clinical disease in New World camelids.

Case summary An 8-year-old domestic longhair cat was evaluated for a right ventral subcutaneous cervical mass. Serial bloodwork and contrast-enhanced cranial and thoracic CT initially lacked ethmoturbinate lysis and showed a progressive, vascularized, right ventral cervical mass involving local lymph nodes. The mass was removed surgically on two occasions. Histopathology and fungal culture were diagnostic for a recurring sclerosing fungal granuloma and pyogranulomatous and eosinophilic lymphadenitis, consistent with Aspergillus species. The cat was treated with oral itraconazole; however, owing to the owner’s non-compliance in administering the medication and disease progression, the cat was humanely euthanized 3 years after diagnosis. Relevance and novel information The development of a cervical subcutaneous fungal granuloma of Aspergillus species in a domestic longhair cat before obvious maxillary, orbital or ethmoturbinate lysis on initial diagnostics is rare and suggests an early onset of lymphatic or hematogenous spread from a suspected nidus of infection within the sinonasal cavity.

Background Renal lymphoma in dogs is rare and has a poor prognosis. Granular lymphocyte morphology is rarely reported in canine renal lymphoma. Mild to moderate polycythemia is reported in a number of canine renal lymphoma cases. Case presentation A 10-year-old Labrador retriever presented to a university veterinary teaching hospital after a 1-month history of polyuria, polydipsia, and pollakiuria and a 2-week history of abdominal distention, lethargy, and increased respiratory effort. Abdominal ultrasound showed a wedge-shaped to rounded, heterogeneously hypoechoic mass lesion in the left kidney. Cytologic analysis of a percutaneous aspirate of the mass was consistent with lymphoma of granular lymphocytes. Severe polycythemia (hematocrit 0.871) was noted on a complete blood cell count. Clonality analysis identified a clonally rearranged T-cell receptor (TCR) gene and immunohistochemical staining was CD3+, CD79a- and CD11d+, supporting cytotoxic T-cell lymphoma. Conclusions To our knowledge, this is the first report of renal cytotoxic T-cell lymphoma with severe polycythemia in a dog. Severe polycythemia and renal cytotoxic T-cell lymphoma are both rare in dogs; this report adds to the body of knowledge on these conditions.

Acute MR due to mechanical mitral valve (MV) complications frequently results in cardiogenic shock and requires emergency surgical intervention. There was limited evidence for alternative treatment like MitraClip for patients at prohibitive surgical risk. We aimed to study the technical features and outcomes of emergency transcatheter edge-to-edge repair (TEER) using the MitraClip system for patients with cardiogenic shock (CS) secondary to acute mitral regurgitation (MR) and mechanical MV complication.We performed institutional review and systemic literature review to identify all TEER for CS patients due to acute mitral regurgitation and mechanical MV complication. Clinical endpoints included device success rate assessed at the end of procedure, ability to wean off MCS, all-cause and cardiovascular mortality at 30-day.Eight patients were identified from institutional review. Detail anatomical analysis found that patients with mechanical MV complications related to myocardial infarction had a lower transseptal height achieved during MitraClip (3.6 ± 0.1 cm vs 4.3 ± 0.3 cm, p = 0.03) than those not related. Pooled analysis for cases from institutional review (n = 8) and systemic literature review (n = 16) was performed. The device success rate was 68.8 %. Seventy-five percent (n = 18) cases required mechanical circulatory support (MCS), and 94.4 % were able to wean off MCS. At 30-day, the cardiovascular mortality was 4.5 % and the all-cause mortality was 9.1 %.In CS patients due to acute MR and mechanical MV complications, TEER with/without MCS was feasible with a reasonable device success rate.

Cutaneous round cell tumors in goats present a diagnostic challenge. In this article, we provide a description of caprine cutaneous mast cell tumors (MCT) and histiocytomas, and report on the validation of anti-human antibodies to CD117/KIT and Iba1 by immunohistochemistry on a range of caprine tissues. Cells immunolabeled for CD117/KIT included resident mast cells in normal lung and skin, interstitial cells of Cajal (intestine), and neuronal cell bodies (brain). Cells immunolabeled for Iba1 included resident macrophages in many tissues including normal lung, dendritic cells (hemolymphatic tissues), Kupffer cells, and microglia. Of 5 cutaneous MCT, only one had metachromasia of cytoplasmic granules; however, neoplastic cells of all 5 MCT had positive immunolabeling for CD117/KIT. The CD117/KIT immunolabeling pattern was predominately focal paranuclear in 3 cases, and cytoplasmic or membranous in 1 case each. Two histiocytomas were identified and had strong positive immunolabeling for Iba1 but not CD117/KIT. All 7 cutaneous round cell tumors described herein occurred in goats less than 4 years of age; the 2 cutaneous histiocytomas were in goats less than 14 months of age. Neither of the cutaneous histiocytomas recurred within 24 months of surgical removal.