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PubMed | University of Pennsylvania, Northwestern University, Intermountain Medical Center, Cardiovascular Research Foundation and 14 more.
Type: Journal Article | Journal: European heart journal | Year: 2016

Based on randomized trials using first-generation devices, transcatheter aortic valve replacement (TAVR) is well established in the treatment of high-risk (HR) patients with severe aortic stenosis (AS). To date, there is a paucity of adjudicated, prospective data evaluating outcomes with newer generation devices and in lower risk patients. We report early outcomes of a large, multicentre registry of inoperable, HR, and intermediate-risk (IR) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve (THV).Patients with severe, symptomatic AS (583 high surgical risk or inoperable and 1078 IR) were enrolled in a multicentre, non-randomized registry at 57 sites in the USA and Canada. All patients received TAVR with the SAPIEN 3 system via transfemoral (n = 1443, 86.9%) and transapical or transaortic (n = 218, 13.1%) access routes. The rate of 30-day all-cause mortality was 2.2% in HR/inoperable patients [mean Society of Thoracic Surgeons (STS) score 8.7%] and 1.1% in IR patients (mean STS score 5.3%); cardiovascular mortality was 1.4 and 0.9%, respectively. In HR/inoperable patients, the 30-day rate of major/disabling stroke was 0.9%, major bleeding 14.0%, major vascular complications 5.1%, and requirement for permanent pacemaker 13.3%. In IR patients, the 30-day rate of major/disabling stroke was 1.0%, major bleeding 10.6%, major vascular complications 6.1%, and requirement for permanent pacemaker 10.1%. Mean overall Kansas City Cardiomyopathy Questionnaire score increased from 47.8 to 67.8 (HR/inoperable, P < 0.0001) and 54.7 to 74.0 (IR, P < 0.0001). Overall, paravalvular regurgitation at 30 days was none/trace in 55.9% of patients, mild in 40.7%, moderate in 3.4%, and severe in 0.0%. Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days, while aortic valve area increased from 0.69 to 1.67 cm(2).The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular #NCT01314313.

PubMed | Heekin Orthopaedic Institute for Research Inc., Stryker Orthopaedics, The Orthopaedic Center, Baylor Scott and White Healthcare and The CORE Institute
Type: Journal Article | Journal: The journal of knee surgery | Year: 2015

We investigated a new revision total knee arthroplasty device and associated instrumentation to determine if it could reduce intraoperative complexity and restore the joint line through the arc of motion. In a prospective multicenter study, a total of 95 consecutive patients undergoing a revision knee arthroplasty were evaluated. Medical history, functional health scores, and intraoperative data were collected. The joint line was restored to 28mm5mm in full extension and 90-degree flexion. Significant improvements were noted in all functional and general health scores. The anatomic boss position may allow for a reduction in instrumentation, as the need for femoral offset adapters was limited. Joint line restoration with proper posterior condylar offset correlated with positive functional outcomes.

Leon M.B.,Columbia University | Smith C.R.,Columbia University | Mack M.J.,Columbia University | Mack M.J.,Baylor Scott and White Healthcare | And 30 more authors.
New England Journal of Medicine | Year: 2016

BACKGROUND Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aorticvalve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients. METHODS We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. RESULTS The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P = 0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P = 0.25). In the transfemoralaccess cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P = 0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation. CONCLUSIONS In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. Copyright © 2016 Massachusetts Medical Society. All rights reserved.

Tong C.W.,Texas A&M University | Tong C.W.,Baylor Scott and White Healthcare | Nair N.A.,Advanced Heart Failure | Doersch K.M.,Texas A&M University | And 2 more authors.
Pflugers Archiv European Journal of Physiology | Year: 2014

Diastolic dysfunction prominently contributes to heart failure with preserved ejection fraction (HFpEF). Owing partly to inadequate understanding, HFpEF does not have any effective treatments. Cardiac myosin-binding protein-C (cMyBP-C), a component of the thick filament of heart muscle that can modulate cross-bridge attachment/detachment cycling process by its phosphorylation status, appears to be involved in the diastolic dysfunction associated with HFpEF. In patients, cMyBP-C mutations are associated with diastolic dysfunction even in the absence of hypertrophy. cMyBP-C deletion mouse models recapitulate diastolic dysfunction despite in vitro evidence of uninhibited cross-bridge cycling. Reduced phosphorylation of cMyBP-C is also associated with diastolic dysfunction in patients. Mouse models of reduced cMyBP-C phosphorylation exhibit diastolic dysfunction while cMyBP-C phosphorylation mimetic mouse models show enhanced diastolic function. Thus, cMyBP-C phosphorylation mediates diastolic function. Experimental results of both cMyBP-C deletion and reduced cMyBP-C phosphorylation causing diastolic dysfunction suggest that cMyBP-C phosphorylation level modulates cross-bridge detachment rate in relation to ongoing attachment rate to mediate relaxation. Consequently, alteration in cMyBP-C regulation of cross-bridge detachment is a key mechanism that causes diastolic dysfunction. Regardless of the exact molecular mechanism, ample clinical and experimental data show that cMyBP-C is a critical mediator of diastolic function. Furthermore, targeting cMyBP-C phosphorylation holds potential as a future treatment for diastolic dysfunction. © 2014 The Author(s).

PubMed | Bryan College, Baylor Scott and White Healthcare, Central Texas VA Healthcare System and University of Central Florida
Type: Journal Article | Journal: Annals of vascular surgery | Year: 2015

Endovenous thermal ablation has emerged as an alternative therapy for the treatment of chronic superficial venous insufficiency (CVI) of the lower extremities. Recanalization, or anatomic failure, of a vein after endovenous radiofrequency ablation (RFA) has been described, albeit an infrequent occurrence. This study was performed to demonstrate risk factors associated with the efficacy of RFA and recanalization in the treatment of CVI.Data were collected in an ongoing multicenter registry, which was retrospectively reviewed. This study reviewed 249 limbs that underwent RFA of either the great saphenous vein (GSV) or the small saphenous vein (SSV) over a three-year period, including only patients for whom an intermediate (6 month) follow-up venous duplex ultrasound was available. Patients in whom recanalization was demonstrated via duplex (n = 17, 6.8%) were analyzed for patient-level characteristics. Logistic regression analysis was performed to determine the existence of any significant clinical risk factors associated with anatomic failure. The need for secondary interventions because of clinical symptoms associated with recanalization was analyzed as well.In this cohort, the initial vein occlusion rate was 93.1%. Segmental (n = 9, 53%) or complete (n = 8, 47%) recanalization was seen in 17 limbs (6.8%) after initial successful GSV ablation. All SSV remained persistently ablated. Anatomic failure was associated with higher rate of clinical symptom recurrence (41% vs. 21%; relative risk (RR), 2.75; 95% confidence interval [CI], 0.99-7.6; P < 0.05) and an increased need for secondary vein procedures in the affected limbs (35% vs. 12%; RR, 3.96; 95% CI, 1.3-11.7; P < 0.05). Two recanalized GSVs required repeated endothermal ablation, in efforts to aid in the healing of ulcerations. Patient factors including diabetes, hypertension, hyperlipidemia, anticoagulation or antiplatelet agent usage, presence of deep venous reflux, or tobacco use did not increase the risk of RFA failure. Comparatively, patients with GSV recanalization had a longer mean follow-up time (63.3 vs. 41.6 weeks) but no difference in disease severity (C4, 35% vs. 17%; C5, 18% vs. 15%; C6, 6% vs. 8%; not significant).Endothermal ablation is an efficacious treatment for CVI with most patients remaining reflux free. Recanalization of an isolated vein segment after RFA, although shown in recent literature to be effected by anatomic risk factors, appears to be a sporadic phenomenon with respect to clinical risk factors. Nevertheless, in our cohort, anatomic failure was associated with a 2-fold increase in symptom recurrence and the need for interval secondary vein procedures. Ultrasound interrogation is recommended especially in patients with persistent or recurrent symptoms or nonhealing ulcerations.

Oguayo K.N.,Baylor Scott and White Healthcare | Oguayo K.N.,Texas A&M University | Oyetayo O.O.,Baylor Scott and White Healthcare | Oyetayo O.O.,Texas A&M University | And 4 more authors.
Pharmacotherapy | Year: 2014

Flecainide is recommended as a first-line antiarrhythmic drug to maintain normal sinus rhythm in patients with atrial fibrillation (AF) who have structurally normal hearts or hypertension without left ventricular hypertrophy. Flecainide is a sodium channel blocker with minimal effects expected on ventricular repolarization. We describe the case of a 32-year-old man with a structurally normal heart and persistent AF who was started on diltiazem and flecainide 50 mg twice/day approximately a year prior to presentation. Due to persistent and bothersome symptoms, his dose was increased to 150 mg twice/day, which was associated with a progressive lengthening of his corrected QT interval. On the day of presentation, he underwent an exercise test as part of his job requirements. While running, he felt lightheaded and experienced a syncopal event and cardiac arrest. An automated external defibrillator was available that displayed polymorphic ventricular tachycardia. The patient was successfully resuscitated. Although rare, this case suggests that flecainide can induce QT prolongation leading to torsades de pointes. Clinicians should be aware and consider periodic evaluations with electrocardiograms. © 2014 Pharmacotherapy Publications, Inc.

PubMed | Baylor University, Wake Forest Baptist Medical Center, Baylor Research Institute, Baylor Scott and White Healthcare and Texas A&M University
Type: Journal Article | Journal: Health informatics journal | Year: 2015

Trauma centers manage an active Trauma Registry from which research, quality improvement, and epidemiologic information are extracted to ensure optimal care of the trauma patient. We evaluated coding procedures using the Relational Trauma Scoring System

Su B.W.,Marin General Hospital | Chaput C.D.,Baylor Scott and White Healthcare
Operative Techniques in Orthopaedics | Year: 2015

Cortical screws in the lumbar spine are an alternative to traditional pedicle screw fixation. The starting point is on the dorsal pars and the trajectory is up and out toward the lateral junction of the pedicle with the vertebral body. It allows for a smaller incision and less lateral dissection when compared with pedicle screw placement. Biomechanical studies have shown that cortical screws are equivalent to pedicle screws, and there is limited evidence of improved fixation with this technique in the setting of low bone density. Clinical studies demonstrate equivalent clinical and radiographic results between cortical screw and pedicle screws when used in conjunction with posterior interbody support. The indications, contraindications, surgical technique, special considerations, and literature surrounding the use of lumbar cortical screws are reviewed. © 2015 Published by Elsevier Inc.

PubMed | Baylor Scott and White Healthcare
Type: Journal Article | Journal: The American Journal of dermatopathology | Year: 2017

Dermatophytic pseudomycetoma represents a chronic infection characterized by a tumor-like growth containing dermatophytes arranged as clustered aggregates (grains) within the dermis. In contrast to mycetomas, they lack sinus tracts and are more common in the scalp. We describe a dermatophytic pseudomycetoma arising in the scalp of an 18-year-old African-American woman. Histopathologic examination showed a dense, mixed-cell infiltrate expanding the dermis. Accompanying this infiltrate were numerous grains scattered throughout the dermis. No sinus tracts were identified, but a number of grains were seen in the epidermal surface, admixed with serum crust. Recognition of a dermatophytic infection as a pseudomycetoma on a biopsy is important, as surgery may be required for a successful treatment.

PubMed | Baylor Scott and White Healthcare
Type: Clinical Trial | Journal: Digestive diseases and sciences | Year: 2015

The creation of no interruption zones (NIZs) reduces medical errors by reducing distraction levels on hospital wards. To date, the effect of a NIZ during colonoscopy has not been evaluated.Assess the effects of a NIZ during colonoscopy, on distraction levels, withdrawal times, and adenoma detection rates (ADRs).This was a non-randomized prospective study of screening colonoscopies at a teaching hospital. The intervention, a NIZ, was created by limiting conversations to the care of the patient undergoing the procedure and posting a do not disturb sign during the withdrawal phase of colonoscopy. Distraction levels, withdrawal times, and ADRs were analyzed at baseline and after the NIZ.The implementation of the NIZ leads to a significant reduction of high-distraction-level environments (13.1 vs. 5.1 %; p < 0.0001). There was a significant decrease in withdrawal time with NIZs; (10.6 vs. 9.9 min, p = 0.0038). There was no significant difference in ADRs (38 % baseline vs. 36 % NIZs, respectively; p = 0.33).Creation of a NIZ was associated with a significant decrease in high-distraction environments and shorter withdrawal times with no significant change in ADRs. Further studies are needed to evaluate whether lower distraction levels in an endoscopy suite translate to improved quality measures.

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