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Objectives This study sought to evaluate the outcomes of the early experience of transcatheter mitral valve replacement (TMVR) with balloon-expandable valves in patients with severe mitral annular calcification (MAC) and reports the first large series from a multicenter global registry. Background The risk of surgical mitral valve replacement in patients with severe MAC is high. There are isolated reports of successful TMVR with balloon-expandable valves in this patient population. Methods We performed a multicenter retrospective review of clinical outcomes of patients with severe MAC undergoing TMVR. Results From September 2012 to July of 2015, 64 patients in 32 centers underwent TMVR with compassionate use of balloon-expandable valves. Mean age was 73 ± 13 years, 66% were female, and mean Society of Thoracic Surgeons score was 14.4 ± 9.5%. The mean mitral gradient was 11.45 ± 4.4 mm Hg and the mean mitral area was 1.18 ± 0.5 cm 2 . SAPIEN valves (Edwards Lifesciences, Irvine, California) were used in 7.8%, SAPIEN XT in 59.4%, SAPIEN 3 in 28.1%, and Inovare (Braile Biomedica, Brazil) in 4.7%. Access was transatrial in 15.6%, transapical in 43.8%, and transseptal in 40.6%. Technical success according to Mitral Valve Academic Research Consortium criteria was achieved in 46 (72%) patients, primarily limited by the need for a second valve in 11 (17.2%). Six (9.3%) had left ventricular tract obstruction with hemodynamic compromise. Mean mitral gradient post-procedure was 4 ± 2.2 mm Hg, paravalvular regurgitation was mild or absent in all. Thirty-day all-cause mortality was 29.7% (cardiovascular = 12.5% and noncardiac = 17.2%); 84% of the survivors with follow-up data available were in New York Heart Association functional class I or II at 30 days (n = 25). Conclusions TMVR with balloon-expandable valves in patients with severe MAC is feasible but may be associated with significant adverse events. This strategy might be an alternative for selected high-risk patients with limited treatment options.

Background Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited and additional interventional approaches are required. Objectives This study sought to report the safety and performance data from the feasibility study with a novel direct annuloplasty system. Methods Seventy-one patients with moderate to severe FMR (mean 67.7 ± 11.3 years of age, left ventricular [LV] ejection fraction 34.0 ± 8.3%), on stable medical heart failure medication were prospectively enrolled. Results Device success rate was 70.4% (n = 50 of 71). No intraprocedural death occurred. In patients receiving implants, 4 patients (8.9%) experienced cardiac tamponade. Thirty-day (n = 45) and 6-month (n = 41) rates for all-cause mortality, stroke, and myocardial infarction were 4.4%, 4.4%, and 0.0% and 12.2%, 4.9%, and 0%, respectively. At 6 months, nonurgent mitral surgery was performed in 1 patient (2.4%) and nonurgent percutaneous repair in 7 patients (17.1%). Echocardiographic core analysis after 6 months showed mitral regurgitation reduction in 50% of treated patients by a mean of 1.3 grades. Concerning mitral valve (MV) annular geometry, we found significant reduction of anterior-posterior (–0.31 ± 0.4 cm) and septal-lateral dimensions (–0.21 ± 0.3 cm), a decreased MV-tenting area (–0.57 ± 1.1 cm2) and increase in MV coaptation length (0.13 ± 0.2 cm). Transthoracic echocardiography indicated reverse LV remodeling with reduction of LV end-diastolic diameter (–0.20 ± 0.4 mm) and volume (–22 ± 39 ml). Treatment was associated with significant improvement in 6-min walking distances (56.5 ± 92.0 m) and improvements in New York Heart Association functional class III/IV at 6 months from 53.3% to 23.3%. Conclusions Percutaneous direct annuloplasty is feasible and safe in high-risk FMR patients. This treatment initiates LV reverse remodeling, and provides clinical improvement during 6 months after treatment. (Mitralign Percutaneous Annuloplasty First in Man Study; NCT01852149).

Introduction: In the certification of primary and comprehensive stroke centers The Joint Commission cites neuro assessments/reassessment (neuro-checks) as one of the most problematic standards. The role of neuro-checks (NC) is to readily detect neurological change, but it is surprising that the assessment has undergone relatively little scientific study. Their effectiveness in detecting worsening in acute ischemic stroke patients has not been well examined. The aim of this study is to establish the usefulness of neuro-checks to detect neurological deterioration. Methods: We performed a retrospective chart review of acute ischemic strokes treated with IV tPA in 2017 at a large Comprehensive Stroke Center. Demographics, baseline and 24-hour NIHSS score, vascular risk factors, vascular syndrome at presentation and neuro-check findings during the first 72 hours following admission were recorded. NC consist of an assessment of orientation, Glasgow Coma Scale (GCS), arm and leg strength and sensation. Neurological deterioration was defined as worsening in the clinical judgement of a vascular neurologist during daily patient visits. Frequency and reasons of neurological deterioration and detection rates by neuro-checks were collected. Results: 107 patients were analyzed (52% male, age 69.7 ± 15.6 [mean+/-SD] years). Mean NIHSS score was 12 ± 7.3 on arrival and 7.8 ± 7.6 at 24 hours. An average of 63.3 ± 13.9 neuro-checks were performed per patient. Neurological deterioration was observed in 28 (26%) patients. Of these, 12 (42%) were detected by NC, 9 (32%) by nurses outside of the scheduled NC time and 7 (25%) remained undetected and were found during follow up physician visits. The most common components of the NC that helped detection were decreased motor strength and confusion. Most common reasons for failure to discover deterioration were gradual decline (3/7 [42%]) and transfer to floor (2/7 [28.5%]). Conclusions: While NC increase the chance of detecting neurological deterioration in patients with acute stroke a significant proportion of deteriorations are found outside scheduled assessments or remained undetected. This suggests that novel monitoring strategies are needed to readily identify worsening neurological status in acute stroke.

Objective To assess the feasibility and outcomes in patients undergoing transvenous transseptal (TS) transcatheter aortic valve replacement (TAVR). Background TS approach for TAVR was abandoned in favor of retrograde transfemoral, transaortic, or transapical approaches. TS TAVR may still be warranted in patients for whom no other approach is feasible. Methods Observational consecutive case series at a single center, to evaluate technical outcomes in inoperable patients with aortic stenosis who had contraindications for other approaches and who underwent TAVR via a transvenous TS antegrade approach using the Edwards–Sapien (ES) valve. Results Over a 4-month period, 9 patients underwent TS TAVR with 26 mm (n = 4) and 23 mm (n = 5) ES valves. Mean age was 84.5 ± 6.6 years and Society of Thoracic Surgeons predicted risk of mortality was 7.8 ± 2.8%. Specific contraindications for other access included iliofemoral arterial diameter

Objective To determine the impact of suture-mediated vascular closure devices (VCDs) on net adverse clinical events (NACEs) after balloon aortic valvuloplasty (BAV). Background Ischemic and bleeding complications are common following transfemoral BAV; however, previous studies have been single center and limited by varying definitions of major bleeding. Methods The Effect of Bivalirudin on Aortic Valve Intervention Outcomes (BRAVOs) study was a retrospective observational study conducted at two high-volume academic centers over a 6-year period designed to compare the effect of bivalirudin versus unfractionated heparin. This is a subanalysis of 428 consecutive patients who underwent BAV (with 10–13 French sheaths) to compare the effect of hemostasis with VCDs versus manual compression utilizing standardized definitions. NACE was defined as the composite of major bleeding and major adverse clinical events (MACEs). All events were adjudicated by an independent clinical events committee who were blinded to antithrombin use. Results Preclosure was performed in 269 (62.8%) of patients. While bivalirudin was used more frequently in those with pre-closure (60.6% vs. 37.7%, P

This study sought to evaluate the outcomes of the early experience of transcatheter mitral valve replacement (TMVR) with balloon-expandable valves in patients with severe mitral annular calcification (MAC) and reports the first large series from a multicenter global registry.The risk of surgical mitral valve replacement in patients with severe MAC is high. There are isolated reports of successful TMVR with balloon-expandable valves in this patient population.We performed a multicenter retrospective review of clinical outcomes of patients with severe MAC undergoing TMVR.From September 2012 to July of 2015, 64 patients in 32 centers underwent TMVR with compassionate use of balloon-expandable valves. Mean age was 73 ± 13 years, 66% were female, and mean Society of Thoracic Surgeons score was 14.4 ± 9.5%. The mean mitral gradient was 11.45 ± 4.4 mm Hg and the mean mitral area was 1.18 ± 0.5 cm(2). SAPIEN valves (Edwards Lifesciences, Irvine, California) were used in 7.8%, SAPIEN XT in 59.4%, SAPIEN 3 in 28.1%, and Inovare (Braile Biomedica, Brazil) in 4.7%. Access was transatrial in 15.6%, transapical in 43.8%, and transseptal in 40.6%. Technical success according to Mitral Valve Academic Research Consortium criteria was achieved in 46 (72%) patients, primarily limited by the need for a second valve in 11 (17.2%). Six (9.3%) had left ventricular tract obstruction with hemodynamic compromise. Mean mitral gradient post-procedure was 4 ± 2.2 mm Hg, paravalvular regurgitation was mild or absent in all. Thirty-day all-cause mortality was 29.7% (cardiovascular = 12.5% and noncardiac = 17.2%); 84% of the survivors with follow-up data available were in New York Heart Association functional class I or II at 30 days (n = 25).TMVR with balloon-expandable valves in patients with severe MAC is feasible but may be associated with significant adverse events. This strategy might be an alternative for selected high-risk patients with limited treatment options.

Transcatheter valve implantation for pure severe native aortic valve insufficiency (AI) without aortic stenosis has recently been described in a small series of inoperable or high-risk patients.1 We describe first transcatheter aortic valve replacement in a man using a novel caval-aortic approach in a high-risk patient with severe AI, who was deemed unsuitable for surgical aortic valve replacement. A 72-year-old man with severely dilated ischemic cardiomyopathy (ejection fraction, 20%) was admitted because of decompensated heart failure. A cardiac catheterization revealed nonobstructive coronary artery disease and severe (>4) AI. His Society of Thoracic Surgeons score was 12.4% mainly because of age, low ejection fraction, New York Heart Association class IV, peripheral arterial disease, severe chronic obstructive pulmonary disease, diabetes mellitus on insulin, and chronic kidney disease stage 3. Given his aforementioned comorbidities, he was deemed high-risk candidate for surgical valve replacement. Because of severe peripheral arterial disease and maximum subclavian diameter

The first transcatheter aortic valve replacement (TAVR) approach was antegrade transvenous transseptal. This approach obligated transseptal catheterization and a more circuitous path to deploy the valve. The procedural complexities associated with the transseptal approach led to its replacement by

Spontaneous coronary artery dissection (SCAD) is a rare cause of acute coronary syndrome (ACS). Consequently, its presentation and optimal treatment are yet to be clearly defined. In the current literature, all case series report less than 50 patients, most of whom are either young peripartum women or women who have used oral contraceptives over long periods. All information in this study was compiled by the database service from two hospitals, the first one between 2003 and 2012 and the second one between 2007 and 2012, to include the clinical characteristics, angiography. and treatment approaches in the study population. The study population consisted in four women (50%) and four men (50%) whose ages ranged between 28 and 57 years. Two women had a history of oral contraceptive use and three women presented during peripartum. None of the patients had traditional cardiovascular risk factors or previous heart disease. In 88% of the cases, the principal diagnoses were non-ST segment elevation myocardial infarction and unstable angina. All patients underwent emergency coronary angiography and percutaneous coronary intervention. Half of them were treated with drug-eluting stents and the other half with bare metal stents. The most frequent type of dissection was NIHBL Type E, and the right coronary artery was the most frequently compromised. SCAD is a rare cause of ACS; however, its identification has improved due to the availability of angiography and new complementary techniques. Regarding treatment, PCI seems effective with adequate long-term results.

The mechanism by which Pseudomonas causes excessive inflammation in the cystic fibrosis lung is unclear. We have reported that arachidonic acid is increased and docosahexaenoic acid (DHA) decreased in lung, pancreas, and ileum from cftr−/−mice. Oral DHA corrected this defect and reversed the pathology. To determine which mediators regulate inflammation in lungs from cftr−/−mice and whether inhibition occurs with DHA, cftr−/−and wild-type (WT) mice were exposed to aerosolized Pseudomonas lipopolysaccharide (LPS). After 2 days of LPS, tumor necrosis factor-α (TNF-α), macrophage inflammatory protein-2, and KC levels in bronchoalveolar lavage fluid were increased in cftr−/−compared with WT mice and not suppressed by pretreatment with oral DHA. Neutrophil levels were not different between cftr−/−and WT mice. After 3 days of aerosolized LPS, neutrophil concentration, TNF-α, and the eicosanoids 6-keto-PGF1α, PGF2α, PGE2, and thromboxane B2were all increased in bronchoalveolar lavage fluid from cftr−/−mice compared with WT controls. Oral DHA had no significant effect on TNF-α levels in cftr−/−mice. In contrast, neutrophils and eicosanoids were decreased in cftr−/−but not in WT mice treated with DHA, indicating that the effects of DHA on these inflammatory parameters may be related to correction of the membrane lipid defect.

In patients with hypertrophic obstructive cardiomyopathy, hemodynamically significant ventricular septal defect after septal myectomy is a rare sequela that warrants closure. Percutaneous closure provides a safer alternative to repeated sternotomy, which is associated with significant morbidity and mortality rates. We report a possibly unique case of successful retrograde percutaneous closure, with an AMPLATZER Muscular VSD Occluder, of an iatrogenic ventricular septal defect consequent to surgical therapy for hypertrophic obstructive cardiomyopathy.

Transcatheter Aortic Valve Replacement (TAVR) improves survival in inoperable patients with severe aortic stenosis (AS). Compared to surgical aortic valve replacement (AVR), TAVR is associated with a higher incidence of paravalvular leaks. The aortic regurgitation (AR) index has been shown to be

Objectives To assess the impact of the Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) on access for patients with aortic stenosis (AS) with transcatheter aortic valve replacement (TAVR) in a tertiary care center. Background TAVR has given hope to patients with AS who are deemed inoperable. The effects of the NCD on access to patients with AS has not been evaluated. Materials and Methods A total of 94 inoperable AS patients were evaluated and treated from December 2011 through June of 2012 with TAVR. Patients who underwent transfemoral (TF) vs. non-TF access were compared. The CMS NCD was released on May 1, 2012 and on July 1, 2012, the nontransfemoral access program was put on hold due to lack of reimbursement. Results Patients in the TF (n = 33) and non-TF access (n = 61) groups were similar in age (85.2 ± 6.3 vs. 84.8 ± 6.6 P = 0.74) and STS mortality (9.38 ± 5.33 vs. 7.91 ± 3.69, P = 0.074). The iliofemoral arteries were larger diameter in the TF group (7.72 ± 1.49 vs. 6.21 ± 1.78, P < 0.001) and males (7.39 ± 1.81 vs. 6.1 ± 1.61 P < 0.001). More women underwent valve implantation via non-TF access (73 vs. 23%, P = 0.03). After the NCD, 21 patients who previously qualified for non-TF TAVR would not be reimbursed by CMS. Four died soon after. Conclusions After the NCD, the proportion of inoperable patients with severe AS that can be treated with TAVR was greatly reduced due the lack of reimbursement for TAVR via non-TF access. This effect is particularly pronounced in women. © 2014 Wiley Periodicals, Inc.

La nocardiosis cutánea se caracteriza por ser una infección localizada o diseminada causada por un actinomiceto aerobio del género nocardia. Se presenta el caso de un paciente de sexo femenino de 60 años y se discute el tratamiento.

Background With the expansion in the use of transcatheter valve therapies for aortic stenosis, the incidence of hemodynamically significant paravalvular regurgitation (PVR) has become a clinical challenge. Methods The study population consisted of those patients with either acute significant PVR immediately post-Edwards SAPIEN (ES) aortic valve implantation, requiring additional maneuvers during the index transcatheter aortic valve replacement (TAVR) or symptomatic PVR requiring treatment by transcatheter closure at a later date. All the patients were assessed within 24 hrs, 30 days, 3 months, 6 months and 12 months after the procedure. Results A total of 100 consecutive patients underwent ES TAVR (62% with 23 mm and 38% with 26 mm valve), of them 27% (27/100) were identified to have hemodynamically significant PVR requiring additional percutaneous interventions during or after the index procedure. Patient's mean age was 85 ± 12 years and 74% (20/27) were male. The mean Society of Thoracic Surgeon Score was 11.3% (range 4.6–17.6%), 59% had a 23 mm and 41% had a 26 mm ES valve. There was no difference in the occurrence of PVR between a) two valve sizes—23 mm (16/62) vs. 26 mm (11/38) (P = 0.817) and b) the two approaches—transfemoral (15/48) vs. transapical (TA) (12/52) (P = 0.37). A total of 32 procedures were performed on the 27 patients: one patient required four and two required two procedures each. There were 19 repeat ballooning, seven valve in valve and six transcatheter device closure procedures. The approach was retrograde in 66%, antegrade transeptal in 6% and antegrade TA in 28%. The procedural success rate was 90.6%, the total 30-day, 3 months and 6 months mortality rate was 7.4, 18.5, and 22% respectively. At the time of final analysis a total of 56% (15/27) had completed a 12 month follow-up. Conclusion The management of PVR in the TAVR era is a technical challenge. We present our experience and propose a management approach. © 2013 Wiley Periodicals, Inc.

Biomarkers are biological parameters that can be objectively measured and quantified as indicators of normal biologic processes, pathogenic processes, or responses to a therapeutic intervention. Typically thought of as disease process screening, diagnosing, or monitoring tools, biomarkers may also be used to determine disease susceptibility and eligibility for specific therapies. Cardiac biomarkers are protein components of cell structures that are released into circulation when myocardial injury occurs. They play a pivotal role in the diagnosis, risk stratification, and treatment of patients with chest pain and suspected acute coronary syndrome and those with acute exacerbations of heart failure. Cardiac markers are central to the new definition of acute myocardial infarction put forward by the American College of Cardiology and the European Society of Cardiology. Active investigation has brought forward an increasingly large number of novel candidate markers but few have withstood the test of time and become integrated into contemporary clinical care because of their readily apparent diagnostic, prognostic, or therapeutic utility.

We present findings from a 59-year-old male patient who presented with coronary artery disease and refractory angina. Ten years prior, the patient had been implanted with 5 bare metal stents (BMS); he arrived with non-specific ST-T wave abnormalities. Angiographic data revealed a totally occluded right coronary artery at the level of the previously placed BMS, consistent with an acute occlusion and a significant thrombus. Our findings revealed that BMS thrombosis can occur as late as 10 years after implantation. Further data through clinical trials are warranted to look at this rare, but serious, complication.

Transcatheter aortic valve replacement (TAVR) was first done via the transseptal (TS) approach, but this was largely abandoned in favor of retrograde transfemoral (TF), transaortic (TAo) or transapical (TA) approaches. TS TAVR may still be warranted in patients for whom no other approach is feasible

Transcatheter aortic valve replacement (TAVR) has become the standard of care for inoperable patients with aortic stenosis (AS). Prior to release of the Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD), the TAVR access route was at the discretion of the treating

Bleeding is an important safety outcome, and has been defined historically in cardiovascular trials using multiple, heterogeneous definitions. The Bleeding Academic Research Consortium (BARC) standardized bleeding definition was developed to address this. However, a formal comparison of these

The risk of surgical mitral valve replacement in patients with severe mitral annular calcification (MAC) is very high due to comorbidities and technical challenges related to calcium burden, precluding surgery in many patients. There are few isolated reports of successful transcatheter mitral valve

Trancatheter aortic valve replacement (TAVR) is associated with a higher risk of stroke as compared to surgical aortic valve replacement. The data on the difference in the incidence of stroke between the transfemoral (TF) vs transapical (TA) approaches is limited to individual studies. We performed