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1.
N Engl J Med ; 388(20): 1833-1842, 2023 May 18.
Article in English | MEDLINE | ID: mdl-36876753

ABSTRACT

BACKGROUND: Severe tricuspid regurgitation is a debilitating condition that is associated with substantial morbidity and often with poor quality of life. Decreasing tricuspid regurgitation may reduce symptoms and improve clinical outcomes in patients with this disease. METHODS: We conducted a prospective randomized trial of percutaneous tricuspid transcatheter edge-to-edge repair (TEER) for severe tricuspid regurgitation. Patients with symptomatic severe tricuspid regurgitation were enrolled at 65 centers in the United States, Canada, and Europe and were randomly assigned in a 1:1 ratio to receive either TEER or medical therapy (control). The primary end point was a hierarchical composite that included death from any cause or tricuspid-valve surgery; hospitalization for heart failure; and an improvement in quality of life as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), with an improvement defined as an increase of at least 15 points in the KCCQ score (range, 0 to 100, with higher scores indicating better quality of life) at the 1-year follow-up. The severity of tricuspid regurgitation and safety were also assessed. RESULTS: A total of 350 patients were enrolled; 175 were assigned to each group. The mean age of the patients was 78 years, and 54.9% were women. The results for the primary end point favored the TEER group (win ratio, 1.48; 95% confidence interval, 1.06 to 2.13; P = 0.02). The incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups. The KCCQ quality-of-life score changed by a mean (±SD) of 12.3±1.8 points in the TEER group, as compared with 0.6±1.8 points in the control group (P<0.001). At 30 days, 87.0% of the patients in the TEER group and 4.8% of those in the control group had tricuspid regurgitation of no greater than moderate severity (P<0.001). TEER was found to be safe; 98.3% of the patients who underwent the procedure were free from major adverse events at 30 days. CONCLUSIONS: Tricuspid TEER was safe for patients with severe tricuspid regurgitation, reduced the severity of tricuspid regurgitation, and was associated with an improvement in quality of life. (Funded by Abbott; TRILUMINATE Pivotal ClinicalTrials.gov number, NCT03904147.).


Subject(s)
Heart Valve Prosthesis Implantation , Tricuspid Valve Insufficiency , Aged , Female , Humans , Male , Cardiac Catheterization/adverse effects , Cardiac Catheterization/methods , Heart Failure/etiology , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Prospective Studies , Quality of Life , Treatment Outcome , Tricuspid Valve Insufficiency/surgery
2.
Dig Dis Sci ; 69(2): 562-569, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38135813

ABSTRACT

BACKGROUND: Long-COVID is a condition post SARS-CoV-2 infection with persistent or recurring symptoms affecting multiple organs, and may involve viral persistence, changes to the microbiome, coagulopathies, and alterations to neuro-immune interactions. These factors can disrupt the Gut-Brain Axis, which is a complex system involving bidirectional communication between the central nervous system and the gastrointestinal (GI) system. As a result of these disruptions, individuals with long-COVID may develop post-infectious functional GI disorders, which can cause a range of symptoms affecting the digestive system. AIM: To understand frequency of GI manifestations of Long-COVID and to determine association with sleep or neurological symptoms in a predominantly minority population. METHODS: We included patients with positive SARS-CoV-2 PCR (n = 747) who were hospitalized from Feb. 2020 to May 2021 at Howard University Hospital and followed between 6 and 12 months from discharge. GI, sleep, and neurological symptoms (via the Montreal Cognitive Assessment (MoCA) scoring system) were assessed using a standardized questionnaire. Linear regression analysis, χ2 and Fisher's exact test were utilized to determine the statistical significance of correlations of GI/Neuro/COVID. RESULTS: The mean age of patients was 58, with 51.6% females and a predominant African American ethnicity (73.6%, n = 550). A total of 108 patients died during their initial hospital stay, with the remaining 639 patients followed-up. Three hundred fifty (350) patients responded to the questionnaire (57 patients died during the follow-up period). Overall, 39 (13.3%) patients reported GI-related symptoms, out of which 19 (6.4%) had persistent symptoms and 20 (6.8%) developed new onset GI symptoms. Nausea and vomiting were the most common 24/39 (61.5%), followed by abdominal pain 7/39 (18%), diarrhea 5/39 (12.8%), and others 3/39 (7.6%). Patients who presented with vomiting during acute SARS-CoV-2 infection were more likely to have Long-COVID GI manifestations (P = 0.023). Use of ACE inhibitors, abnormal lymphocyte count and elevated ferritin are other variables that showed significant associations with Long-COVID GI manifestations (P = 0.03, 0.006 and 0.03, respectively). During follow-up, a total of 28 (9.5%) patients reported difficulty with sleep and 79 (27%) patients had abnormal MoCA assessment. With further analysis, there was a trend between presentation of GI symptoms on admission with abnormal MoCA assessment, and an association between abnormal LFTs and history of liver disease during hospitalization with subsequent sleep problems. Baseline characteristics, clinical comorbidities, other laboratory values, hospital length of stay, mechanical ventilation, medications during hospitalization, re-admission and Flu or COVID-19 vaccination have not shown any association with Long-COVID GI symptoms in our cohort. CONCLUSION: Dyspeptic symptoms were common GI manifestations in the acute and post COVID periods. GI symptoms, abnormal LFTs and a history of liver disease during the acute infectious phase associates with abnormal MoCA and sleep problems during follow-up. Further large population studies are needed to determine if COVID-19 leads to a GI symptoms-associated Long-COVID phenotypes and other symptoms through the Gut-Brain-Axis.


Subject(s)
COVID-19 , Gastrointestinal Diseases , Liver Diseases , Sleep Wake Disorders , Female , Humans , Male , COVID-19/complications , COVID-19/diagnosis , COVID-19/epidemiology , SARS-CoV-2 , Follow-Up Studies , Post-Acute COVID-19 Syndrome , Prospective Studies , COVID-19 Vaccines , Gastrointestinal Diseases/diagnosis , Gastrointestinal Diseases/epidemiology , Gastrointestinal Diseases/etiology , Liver Diseases/complications , Vomiting , Sleep Wake Disorders/etiology , Sleep Wake Disorders/complications
3.
Eur J Orthop Surg Traumatol ; 34(1): 75-89, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37656278

ABSTRACT

PURPOSE: A locking plate (LP) or non-locking plate (NLP) can be used for distal fibula fracture fixation. However, the advantages of LP over NLP in patients with distal fibula fractures are not clear. In terms of indications, the role of the two plates probably differs; however, to draw comparative conclusions, we conceptualized this systematic review and meta-analysis of studies that directly compared the two plates, wherein both groups' indications and baseline parameters were similar. METHODS: An electronic literature search was performed using PubMed/Medline, Embase, Scopus, and Cochrane Library databases for studies comparing the LP versus NLP fixation for the lateral malleolus fracture. A total of 18 studies were included in qualitative and quantitative analysis. A subgroup analysis was performed for patients aged < 55 years and patients aged > 55 years. The statistical analysis was performed by Review Manager Software version 5.4.1. RESULTS: A meta-analysis of 4243 fractures was performed across 18 studies. The rate of fracture union and overall complication rates did not differ between the two fixation groups with an OR of 0.71 (95% CI 0.26, 1.96, p = 0.51 and 1.11 (95% CI 0.84, 1.47, p = 0.47, respectively. There is no difference in the reoperation rate due to minor or major complications between the two groups. There was no difference in functional outcome (MD -0.85, with 95% CI -5.63, 3.93, p = 0.73), but NLP has a shorter surgical duration (MD 3.0, with 95% CI 0.26, 5.75, p = 0.03). A leave-one-out sensitivity analysis performed for overall complications affected the final outcome of the meta-analysis. CONCLUSION: This meta-analysis demonstrates no clear benefit in selecting LP over NLP for the fixation of lateral malleolus fractures.


Subject(s)
Ankle Fractures , Fibula Fractures , Humans , Ankle Fractures/surgery , Fracture Fixation, Internal/adverse effects , Reoperation , Bone Plates , Fibula/surgery , Treatment Outcome
4.
Europace ; 25(4): 1415-1422, 2023 04 15.
Article in English | MEDLINE | ID: mdl-36881781

ABSTRACT

AIMS: To determine outcomes in atrial fibrillation patients undergoing percutaneous left atrial appendage occlusion (LAAO) based on the underlying stroke risk (defined by the CHA2DS2-VASc score). METHODS AND RESULTS: Data were extracted from the National Inpatient Sample for calendar years 2016-20. Left atrial appendage occlusion implantations were identified on the basis of the International Classification of Diseases, 10th Revision, Clinical Modification code of 02L73DK. The study sample was stratified on the basis of the CHA2DS2-VASc score into three groups (scores of 3, 4, and ≥5). The outcomes assessed in our study included complications and resource utilization. A total of 73 795 LAAO device implantations were studied. Approximately 63% of LAAO device implantations occurred in patients with CHA2DS2-VASc scores of 4 and ≥5. The crude prevalence of pericardial effusion requiring intervention was higher with increased CHA2DS2-VASc score (1.4% in patients with a score of ≥5 vs. 1.1% in patients with a score of 4 vs. 0.8% in patients with a score of 3, P < 0.01). In the multivariable model adjusted for potential confounders, CHA2DS2-VASc scores of 4 and ≥5 were found to be independently associated with overall complications [adjusted odds ratio (aOR) 1.26, 95% confidence interval (CI) 1.18-1.35, and aOR 1.88, 95% CI 1.73-2.04, respectively] and prolonged length of stay (aOR 1.18, 95% CI 1.11-1.25, and aOR 1.54, 95% CI 1.44-1.66, respectively). CONCLUSION: A higher CHA2DS2-VASc score was associated with an increased risk of peri-procedural complications and resource utilization after LAAO. These findings highlight the importance of patient selection for the LAAO procedure and need validation in future studies.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Stroke , Humans , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Stroke/diagnosis , Stroke/epidemiology , Stroke/etiology , Atrial Appendage/surgery , Retrospective Studies , Treatment Outcome
5.
Europace ; 24(9): 1451-1459, 2022 10 13.
Article in English | MEDLINE | ID: mdl-35613020

ABSTRACT

AIMS: To determine outcomes in atrial fibrillation (AF) patients undergoing percutaneous left atrial appendage occlusion (LAAO) with concomitant heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF). METHODS AND RESULTS: Data were extracted from National Inpatient Sample for calendar years 2015-2019. LAAO device implantations were identified on the basis of ICD-10-CM code of 02L73DK. The outcomes assessed in our study included complications, in-patient mortality, and resource utilization. A total of 62 980 LAAO device implantations were studied. HFpEF (14.4%, n = 9040) and HFrEF (11.2%, n = 7100) were associated with a higher prevalence of major complications and in-patient mortality in crude analysis. In the multivariate model adjusted for potential confounders, HFpEF and HFrEF were not associated with major complications [adjusted odds ratio (aOR) 1.04, 95% confidence interval (CI) 0.93-1.16 and aOR 1.07, 95% CI 0.95-1.21] or in-patient mortality (aOR 1.48, 95% CI 0.85-2.55 and aOR 1.26, 95% CI 0.67-2.38). HFpEF and HFrEF were associated with prolonged length of stay (LOS) > 1 day (aOR 1.41, 95% CI 1.31-1.53 and aOR 1.66, 95% CI 1.53-1.80) and increased hospitalization costs > median cost 24 752$ (aOR 1.26, 95% CI 1.19-1.34 and aOR 1.21, 95% CI 1.13-1.29). CONCLUSION: The prevalence of HF in AF patients undergoing percutaneous LAAO was approximately 26%. HF was not independently associated with major complications and in-patient mortality but was associated with prolonged LOS and higher hospitalization costs.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Heart Failure , Atrial Appendage/surgery , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Atrial Fibrillation/surgery , Heart Failure/diagnosis , Heart Failure/epidemiology , Heart Failure/therapy , Hospitals , Humans , Inpatients , Prognosis , Stroke Volume/physiology
6.
J Immunol ; 205(10): 2806-2820, 2020 11 15.
Article in English | MEDLINE | ID: mdl-33055281

ABSTRACT

Intermediate monocytes (iMo; CD14+CD16+) increase in number in the circulation of patients with unstable coronary artery disease (CAD), and their recruitment to inflamed arteries is implicated in events leading to mortality following MI. Monocyte recruitment to inflamed coronary arteries is initiated by high affinity ß2-integrin (CD11c/CD18) that activates ß1-integrin (VLA-4) to bind endothelial VCAM-1. How integrin binding under shear stress mechanosignals a functional shift in iMo toward an inflammatory phenotype associated with CAD progression is unknown. Whole blood samples from patients treated for symptomatic CAD including non-ST elevation MI, along with healthy age-matched subjects, were collected to assess chemokine and integrin receptor levels on monocytes. Recruitment on inflamed human aortic endothelium or rVCAM-1 under fluid shear stress was assessed using a microfluidic-based artery on a chip (A-Chip). Membrane upregulation of high affinity CD11c correlated with concomitant activation of VLA-4 within focal adhesive contacts was required for arrest and diapedesis across inflamed arterial endothelium to a greater extent in non-ST elevation MI compared with stable CAD patients. The subsequent conversion of CD11c from a high to low affinity state under fluid shear activated phospho-Syk- and ADAM17-mediated proteolytic cleavage of CD16. This marked the conversion of iMo to an inflammatory phenotype associated with nuclear translocation of NF-κB and production of IL-1ß+ We conclude that CD11c functions as a mechanoregulator that activates an inflammatory state preferentially in a majority of iMo from cardiac patients but not healthy patients.


Subject(s)
CD11c Antigen/metabolism , Coronary Artery Disease/immunology , Endothelium, Vascular/immunology , Monocytes/immunology , Non-ST Elevated Myocardial Infarction/immunology , Adult , Aged , Allosteric Regulation/immunology , Aorta/cytology , Case-Control Studies , Cell Culture Techniques , Cell Line , Cell Membrane/metabolism , Coronary Artery Disease/blood , Coronary Artery Disease/surgery , Coronary Vessels/cytology , Coronary Vessels/immunology , Endothelial Cells/cytology , Endothelial Cells/immunology , Endothelial Cells/metabolism , Endothelium, Vascular/metabolism , Female , Humans , Integrin alpha4beta1/metabolism , Lab-On-A-Chip Devices , Male , Microfluidic Analytical Techniques/instrumentation , Middle Aged , Non-ST Elevated Myocardial Infarction/blood , Non-ST Elevated Myocardial Infarction/surgery , Percutaneous Coronary Intervention , Recombinant Proteins/immunology , Recombinant Proteins/metabolism , Transendothelial and Transepithelial Migration/immunology , Vascular Cell Adhesion Molecule-1/immunology , Vascular Cell Adhesion Molecule-1/metabolism
7.
Catheter Cardiovasc Interv ; 97(4): 745-754, 2021 03.
Article in English | MEDLINE | ID: mdl-33045138

ABSTRACT

BACKGROUND: During MitraClip implantation sub-valvular correction of trajectory and/or alignment may increase adverse clip or leaflet events. With systematic adjunctive use of fluoroscopy ("Parallax technique"), we aimed to assess parameters that minimize the need for corrective measures and help increase procedural efficiency. METHODS: We retrospectively analyzed 30 patients without (Fl-) and 39 patients utilizing adjunctive fluoroscopy (Fl+) during MitraClip implantation. After establishing trajectory and supra-valvular alignment, the Parallax technique was utilized. Trajectory and alignment are maintained during advancement. RESULTS: All patients had 3 or 4+ MR. There were no differences in baseline demographics. The average number of clips (Fl- vs Fl+) was 1.72 ± 0.8 vs 1.59 ± 0.5, p = .57. For the first clip, the need for sub-valvular alignment (80% vs. 36%, p = .0001), eversion with retraction back to left atrium (23% vs. 10%, p = .001) and the number of grasps (2.3 ± 1.2 vs 1.4 ± 0.9) was reduced. The time from transseptal puncture to first clip deployment (71 ± 21 vs 44 ± 16 min, p = .01) was reduced. Procedural success was achieved in all but one patient in the Fl- group (p = ns). There were no differences noted for in-hospital or 30-day outcomes. CONCLUSIONS: Systematic use of a simple and easy to implement "Parallax technique" was associated with reduced need for sub-valvular manipulation and was associated with improved procedural times. Further larger scale studies are needed to assess the applicability of the technique.


Subject(s)
Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Fluoroscopy , Humans , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Retrospective Studies , Treatment Outcome
8.
Catheter Cardiovasc Interv ; 96(1): 210-214, 2020 07.
Article in English | MEDLINE | ID: mdl-31617308

ABSTRACT

MitraClip is used for reduction of mitral insufficiency in patients who are not good surgical candidates, but with expanding indications, the use of MitraClip and the number of complications will increase. Here is presented a case of a single leaflet device attachment that worsened the patient's mitral insufficiency, as well as the technique for stabilizing the valve followed by retrieval of the device. A special focus is placed on removing the using a two-snare technique to avoid the need for a surgical cutdown and repair.


Subject(s)
Cardiac Catheterization , Device Removal , Foreign-Body Migration/therapy , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis , Mitral Valve Insufficiency/surgery , Mitral Valve/surgery , Aged , Female , Foreign-Body Migration/diagnostic imaging , Foreign-Body Migration/etiology , Heart Atria/diagnostic imaging , Humans , Mitral Valve/diagnostic imaging , Mitral Valve/physiopathology , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/physiopathology , Treatment Outcome
9.
Catheter Cardiovasc Interv ; 96(3): 699-705, 2020 09 01.
Article in English | MEDLINE | ID: mdl-32259371

ABSTRACT

The MitraClip procedure is carried out almost exclusively via the transfemoral approach. However, in some patients transfemoral delivery of MitraClip is not technically feasible (e.g., occluded inferior vena cava or tortuous/obstructive iliofemoral venous anatomy). The technical considerations and challenges of the MitraClip procedure are amplified when an alternate route is considered. We describe a successful case of MitraClip performed via the right internal jugular (IJ) approach in a patient with a flail A3 scallop and previous mitral valve repair. We reviewed prior cases in the literature and discuss step-by-step the pertinent clinical and technical considerations for performing this procedure via the transjugular route. In summary, the right IJ access site provides a reasonable alternative to perform the MitraClip procedure in cases where femoral access is contraindicated or prohibitive. A thorough understanding of the technical considerations is crucial in improving procedural success rates.


Subject(s)
Cardiac Catheterization/instrumentation , Catheterization, Central Venous , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis , Jugular Veins , Mitral Valve Annuloplasty/instrumentation , Mitral Valve Insufficiency/surgery , Mitral Valve/surgery , Humans , Jugular Veins/diagnostic imaging , Male , Middle Aged , Mitral Valve/diagnostic imaging , Mitral Valve/physiopathology , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/physiopathology , Recovery of Function , Reoperation , Treatment Outcome
10.
Catheter Cardiovasc Interv ; 96(3): E387-E392, 2020 09 01.
Article in English | MEDLINE | ID: mdl-32077578

ABSTRACT

OBJECTIVES: To propose a novel method for mapping leak location and frequency to a clock-face representation of the left atrial appendage (LAA) ostium. BACKGROUND: LAA occlusion with the Watchman device (WD) is an established therapy to reduce thromboembolic events in patients with atrial fibrillation (AF) and intolerance to long-term oral anticoagulation. Postimplantation leaks are known sequelae, but leak locations and characteristics are poorly described. METHODS: We retrospectively reviewed 101 consecutive WD implants from April 2015 to February 2018. Leak locations from 6-week post-implant transesophageal echocardiograms were mapped to a clock-face representation of the LAA ostium: 12:00 as cranial near the limbus, 3:00 as anterior toward the pulmonary artery, 6:00 as caudal near the mitral annulus, and 9:00 as posterior. Patient demographics, LAA dimensions, and procedural characteristics were also collected. RESULTS: Thirty-four patients had ≥1 leak totaling 45 leaks at 6-week follow-up. Baseline patient demographics showed a mean age 77, CHA2 DS2 VASc 4.69, and 64% of patients with permanent AF. No patient had a detectable leak at the time of implant. At 6 weeks, mean leak size was 2.67 ± 0.89 mm with no leak over 5 mm (largest 4.60 mm). Most leaks occurred along the posterior 6:00-12:00 segment (39/45) and the 6:00-9:00 quadrant (16/45). CONCLUSION: Six-week post-WD implant leaks localize to the posterior LAA ostium. This could result from the elliptical LAA orifice, differential LAA tissue composition, or implantation technique. This study provides a novel method for describing the location of post-implant leaks and serves as the basis for further investigations.


Subject(s)
Atrial Appendage/diagnostic imaging , Atrial Fibrillation/therapy , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Echocardiography, Transesophageal , Prosthesis Failure , Septal Occluder Device , Aged , Aged, 80 and over , Anatomic Landmarks , Atrial Appendage/physiopathology , Atrial Fibrillation/diagnosis , Atrial Fibrillation/physiopathology , Female , Humans , Male , Predictive Value of Tests , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome
11.
Catheter Cardiovasc Interv ; 95(3): 414-419, 2020 02 15.
Article in English | MEDLINE | ID: mdl-31638326

ABSTRACT

A transseptal puncture is critical for "left-sided" structural heart interventions. Procedures such as transcatheter edge-to-edge repair (MitraClip) and left atrial appendage (LAA) closure (Watchman) require precise puncture of the interatrial septum (IAS), and the presence of a prior atrial septal defect (ASD) closure device poses a challenge. We aim to present a successfully completed case of MitraClip and Watchman in the presence of ASD closure device in two different patients. A review of the literature will be reported, and pertinent clinical and technical considerations will be discussed in depth to achieve procedural success. In summary, transseptal puncture for left heart structural interventions is feasible in the presence of a prior ASD/patent foramen ovale closure device. A detailed understanding of the anatomical considerations as well as the use of multimodality imaging to evaluate the IAS will aid in improving procedural success rates.


Subject(s)
Atrial Fibrillation/therapy , Cardiac Catheterization , Heart Septal Defects, Atrial/therapy , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency/surgery , Mitral Valve/surgery , Aged, 80 and over , Atrial Fibrillation/diagnosis , Atrial Fibrillation/physiopathology , Cardiac Catheterization/instrumentation , Female , Heart Septal Defects, Atrial/diagnostic imaging , Heart Septal Defects, Atrial/physiopathology , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/instrumentation , Hemodynamics , Humans , Male , Mitral Valve/diagnostic imaging , Mitral Valve/physiopathology , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/physiopathology , Punctures , Recovery of Function , Risk Factors , Severity of Illness Index , Treatment Outcome
12.
Catheter Cardiovasc Interv ; 95(4): 748-755, 2020 03 01.
Article in English | MEDLINE | ID: mdl-31905260

ABSTRACT

BACKGROUND: Patients with critical limb ischemia often have infrapopliteal (IP) chronic total occlusions (CTOs). While revascularization is indicated to prevent major amputation, anterograde crossing of these lesions can be challenging, with high failure rates. OBJECTIVE: To develop and validate a scoring system that can adequately predict successful anterograde crossing of infrapopliteal CTOs. METHODS AND RESULTS: A total of 213 IP CTOs (147 successfully crossed with the anterograde approach vs. 66 where anterograde crossing failed) were included in the analysis. Backwards stepwise selection (p for retention <.05) was used to create a multivariable logistic regression model for the prediction of successful anterograde crossing using variables that were found to have a p < .1 in univariate analysis. The model was internally validated with bootstrapping and demonstrated excellent discriminatory ability (C-statistic 0.78 and Hosmer-Lemeshow p value = .61). A point score based on the beta-coefficient of the model variables was created, with one point assigned for presence of a noncentral (blunt) stump, one point for severe calcification at the entry site, and two points each for non-restenotic lesions or lesion length > 200 mm. The score was shown to have an excellent discriminatory ability for successful crossing, with low scores (0-2) associated with low failure rates (10%) and high scores associated with high failure rates (79%). CONCLUSIONS: The Infrapop-CTO score can stratify the procedural complexity of IP CTOs based on the likelihood of successful anterograde crossing. This score may help to direct optimal approaches toward infrapopliteal revascularization of patients with critical limb ischemia.


Subject(s)
Clinical Decision Rules , Endovascular Procedures , Ischemia/therapy , Peripheral Arterial Disease/therapy , Popliteal Artery , Chronic Disease , Critical Illness , Endovascular Procedures/adverse effects , Humans , Ischemia/diagnosis , Ischemia/physiopathology , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/physiopathology , Popliteal Artery/physiopathology , Predictive Value of Tests , Reproducibility of Results , Retrospective Studies , Risk Assessment , Risk Factors , Treatment Outcome
13.
Catheter Cardiovasc Interv ; 95(3): 439-446, 2020 02 15.
Article in English | MEDLINE | ID: mdl-31816169

ABSTRACT

BACKGROUND: Femoropopliteal (FP) artery is one of the most anatomically challenging areas for sustained stent patency. The incidence of FP in-stent restenosis (ISR) is estimated at 50% at 24 months. Prior studies have shown that lesion debulking with laser atherectomy (LA) combined with drug coated balloon (DCB) have superior outcomes compared to LA + balloon angioplasty (BA) ISR, but there have not been studies evaluating 2-year outcomes. METHODS: This was a dual-center retrospective cohort study that compared patients with FP-ISR treated with LA + DCB versus LA + BA. Cox regression analysis was used to examine 2-year outcomes of target lesion revascularization (TLR) and the composite outcome of TLR or restenosis. Multivariable analysis was performed for clinical and statistically significant (in the univariate analysis) variables. RESULTS: One hundred and seventeen consecutive patients with Tosaka II (n = 32) and III (n = 85) ISR were analyzed. Sixty-six patients were treated with LA + DCB and 51 with LA + BA. The LA + DCB group had more lesions with moderate to severe calcification (58% vs. 13%; p < .0001). The LA + DCB group was more likely to be treated with the use of embolic protection devices (64% vs. 23%, p < .001) and cutting balloons (61% vs. 6%, p < .001). Bail-out stenting rates were lower in the LA + DCB group (32% vs. 57%, p = .008). LA + DCB was superior (HR: 0.57; 95% CI: 0.34-0.9, p = .027) for the composite outcome of 2-year TLR or restenosis. The 12-month KM estimates for freedom from TLR or restenosis were 66% in the LA + DCB group versus 46% in the LA + BA group. The 24-month KM estimates were 45% in the LA + DCB group versus 24% in the LA + BA group. CONCLUSIONS: The combination of DCB + LA was associated with decreased rates of bail-out stenting and improved 2-year TLR or restenosis rates. Randomized clinical trials examining the DCB + LA combination for FP-ISR are needed.


Subject(s)
Angioplasty, Balloon/instrumentation , Atherectomy , Coated Materials, Biocompatible , Endovascular Procedures/instrumentation , Femoral Artery/surgery , Laser Therapy , Peripheral Arterial Disease/therapy , Popliteal Artery/surgery , Stents , Aged , Aged, 80 and over , Angioplasty, Balloon/adverse effects , Atherectomy/adverse effects , Constriction, Pathologic , Databases, Factual , Endovascular Procedures/adverse effects , Female , Femoral Artery/diagnostic imaging , Femoral Artery/physiopathology , Humans , Laser Therapy/adverse effects , Male , Middle Aged , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Popliteal Artery/diagnostic imaging , Popliteal Artery/physiopathology , Recurrence , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , United States , Vascular Patency
14.
Catheter Cardiovasc Interv ; 96(1): 145-155, 2020 07.
Article in English | MEDLINE | ID: mdl-32061033

ABSTRACT

Evidence-based recommendations for clinical practice are intended to help health care providers and patients make decisions, minimize inappropriate practice variation, promote effective resource use, improve clinical outcomes, and direct future research. The Society for Cardiovascular Angiography and Interventions (SCAI) has been engaged in the creation and dissemination of clinical guidance documents since the 1990s. These documents are a cornerstone of the society's education, advocacy, and quality improvement initiatives. The publications committee is charged with oversight of SCAI's clinical documents program and has created this manual of standard operating procedures to ensure consistency, methodological rigor, and transparency in the development and endorsement of the society's documents. The manual is intended for use by the publications committee, document writing groups, external collaborators, SCAI representatives, peer reviewers, and anyone seeking information about the SCAI documents program.


Subject(s)
Advisory Committees/standards , Angiography/standards , Cardiac Catheterization/standards , Endovascular Procedures/standards , Manuals as Topic/standards , Percutaneous Coronary Intervention/standards , Practice Guidelines as Topic/standards , Societies, Medical/standards , Evidence-Based Medicine/standards , Humans , Writing/standards
15.
Vasc Med ; 25(5): 427-435, 2020 10.
Article in English | MEDLINE | ID: mdl-32460647

ABSTRACT

The association between active smoking and wound healing in critical limb ischemia (CLI) is unknown. Our objective was to examine in a retrospective cohort study whether active smoking is associated with higher incomplete wound healing rates in patients with CLI undergoing endovascular interventions. Smoking status was assessed at the time of the intervention, comparing active to no active smoking, and also during follow-up visits at 6 and 9 months. Cox regression analysis was conducted to compare the incomplete wound healing rates of the two groups during follow-up. A total of 264 patients (active smokers: n = 41) were included. Active smoking was associated with higher rates of incomplete wound healing in the 6-month univariate Cox regression analysis (hazard ratio (HR) for incomplete wound healing: 4.54; 95% CI: 1.41-14.28; p = 0.012). The 6-month Kaplan-Meier (KM) estimates for incomplete wound healing were 91.1% for the active smoking group versus 66% for the non-current smoking group. Active smoking was also associated with higher rates of incomplete wound healing in the 9-month univariable (HR for incomplete wound healing: 2.32; 95% CI: 1.11-4.76; p = 0.026) and multivariable analysis (HR for incomplete wound healing: 9.09; 95% CI: 1.06-100.0; p = 0.044). The 9-month KM estimates for incomplete wound healing were 75% in the active smoking group versus 54% in the non-active smoking group. In conclusion, active smoking status at the time of intervention in patients with CLI is associated with higher rates of incomplete wound healing during both 6- and 9-month follow-up.


Subject(s)
Endovascular Procedures , Ischemia/therapy , Peripheral Arterial Disease/therapy , Smokers , Smoking/adverse effects , Wound Healing , Aged , Aged, 80 and over , Critical Illness , Endovascular Procedures/adverse effects , Female , Humans , Ischemia/diagnosis , Ischemia/physiopathology , Male , Middle Aged , Non-Smokers , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/physiopathology , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
17.
Catheter Cardiovasc Interv ; 94(6): 829-836, 2019 Nov 15.
Article in English | MEDLINE | ID: mdl-31001927

ABSTRACT

OBJECTIVES: Review indications and outcomes for transcatheter iatrogenic atrial septal defect (iASD) closure in patients undergoing MitraClip or transseptal (TS) mitral valve-in-valve/ring (ViV/ViR) procedures. BACKGROUND: Mitral valve transcatheter interventions require large-diameter TS sheaths that can result in iASDs that necessitate post-procedure transcatheter closure. Although the presence of iASD has been well-described, indications for closure and outcomes after TS mitral valve interventions have not been reported. METHODS: Patients undergoing MitraClip repair and ViV or ViR transcatheter mitral valve replacement (TMVR) from February 14, 2014, to January 16, 2018, were studied retrospectively in this single center study. RESULTS: Seventeen patients had iASD closure: 11 MitraClip and 6 TMVR (5 ViV, 1 ViR). Indications for iASD closure included large iASD (n = 7), large left-to-right shunt (n = 9), pulmonary hypertension (n = 8), large right-to-left shunt (n = 1), severe RV dysfunction (n = 2), thin/aneurysmal septum (n = 2), and mobile material on pacemaker leads (n = 2). Closures were performed without complications using Amplatzer septal occluders. At 30 days, 94% of subjects (n = 16) were alive with one patient deceased from unknown causes. There were no myocardial infarctions or strokes. At 12 months, follow-up was available for 14 of 17 patients, and 71% of patients (10/14) were alive. One patient died due to cardiac causes, two from noncardiac causes and one for unknown reasons. There was one myocardial infarction, one intraparenchymal hemorrhage, and no ischemic strokes. CONCLUSIONS: The most common reasons for iASD closure after TS MV procedures are: large ASD unlikely to spontaneously close, large left-to-right shunt, and pulmonary hypertension. Patients who required iASD closure had low 30-day mortality but higher one-year mortality potentially reflecting a population with substantial comorbidities.


Subject(s)
Atrial Septum/injuries , Cardiac Catheterization/adverse effects , Heart Injuries/therapy , Heart Valve Prosthesis Implantation/adverse effects , Mitral Valve/surgery , Aged , Aged, 80 and over , Atrial Septum/diagnostic imaging , Cardiac Catheterization/instrumentation , Cardiac Catheterization/mortality , Cardiac Catheters , Female , Heart Injuries/diagnostic imaging , Heart Injuries/etiology , Heart Injuries/mortality , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/mortality , Humans , Iatrogenic Disease , Male , Mitral Valve/diagnostic imaging , Retrospective Studies , Risk Factors , Septal Occluder Device , Time Factors , Treatment Outcome
18.
Catheter Cardiovasc Interv ; 93(5): E311-E317, 2019 04 01.
Article in English | MEDLINE | ID: mdl-30311343

ABSTRACT

OBJECTIVES: To compare left atrial appendage (LAA) angiography to transesophageal echocardiography (TEE) for assessing usable LAA depth. BACKGROUND: TEE is typically employed for procedural measurement of LAA ostial diameter and depth. Since angiography enhances distal LAA anatomy, we sought to compare angiography to TEE for determining usable LAA depth. METHODS: Seventy five Watchman device cases were retrospectively evaluated. Two independent cardiologists measured intraoperative LAA ostial diameter and depth at standard 0°, 45°, 90°, and 135° TEE omniplane views and in the right anterior oblique (RAO) 30°, caudal (CAUD) 30° angiographic view. RESULTS: The average age and CHA2 DS2 VASc score were 74 (±7.2) years and 4.6 (±1.3), respectively. The average ostial diameter and depth (mm) by TEE were 0°: 19.6 and 26.5; 45°: 17.5 and 26.6; 90°: 18.3 and 25.1; 135°: 19.5 and 23.3. The ostial diameter and depth (mm) by RAO 30° CAUD 30° angiography were 21.1 and 29.7. This angiographic view corresponds to a TEE view between 90° and 135°. In comparison to angiography, TEE 90° underestimated the LAA ostial diameter by 2.9 ± 3.7 mm (P < 0.001) and by 1.9 ± 4.0 mm at TEE 135° (P < 0.01); Pearson's r 0.53 angiography/TEE 90° and 0.50 angiography/TEE 135°. More importantly, TEE 90° underestimated the true usable LAA depth by 5.4 ± 5.8 mm (P < 0.001) and by 7.3 ± 6.1 mm at TEE 135° (P < 0.001); Pearson's r 0.39 angiography/TEE 90° and 0.30 angiography/TEE 135°. CONCLUSIONS: Compared to TEE, LAA angiography provides additional depth information and may be particularly valuable when patients have insufficient depth for Watchman by TEE measures.


Subject(s)
Atrial Appendage/diagnostic imaging , Atrial Fibrillation/therapy , Cardiac Catheterization/instrumentation , Coronary Angiography , Echocardiography, Transesophageal , Aged , Aged, 80 and over , Atrial Appendage/physiopathology , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/physiopathology , Atrial Function, Left , Cardiac Catheterization/adverse effects , Female , Humans , Male , Predictive Value of Tests , Retrospective Studies , Treatment Outcome
19.
Catheter Cardiovasc Interv ; 93(1): E49-E55, 2019 01 01.
Article in English | MEDLINE | ID: mdl-30351515

ABSTRACT

OBJECTIVES: To examine the association between a contralateral carotid artery occlusion (CCO) and the rates of subsequent target-lesion restenosis and revascularization after carotid artery stenting (CAS). BACKGROUND: Patients with carotid artery disease undergoing revascularization often have a CCO. The association of a CCO with long-term outcomes after CAS is uncertain. METHODS: At two institutions, 267 CAS procedures were performed from 2006 to 2016 including 47 (18%) with a CCO. Regular follow-up with duplex carotid ultrasound was performed to assess for restenosis. Univariate Cox regression analysis was performed to evaluate the association between the presence of a CCO and repeat revascularization. RESULTS: The mean patient age was 70 years. There was no significant difference (P > 0.05) in procedural indication (asymptomatic vs ischemic symptoms) or medical comorbidities between groups. During 5-year follow up, the rate of duplex-derived >80% stenosis was 6% in the non-CCO group and 9% in the CCO group (P = 0.45). Despite similar rates of >80% restenosis, there was a significant association between CCO and subsequent target-lesion revascularization (TLR), with rates of 6.4% vs 0.9% at 5 years (HR 7.2, confidence interval (CI) 1.2-43, P = 0.04). There were no significant differences between groups in the 5-year rates of stroke (4.3% in CCO group vs 4.5% in non-CCO group, HR 0.53, CI 0.07-4.22, P = 1.0) or MACCE (15% vs 18%, HR 0.55, CI 0.2-1.55, P = 0.68). CONCLUSIONS: Patients undergoing CAS with a CCO were more likely to undergo TLR during long-term follow up, but they did not have any differences in procedural success or short- and long-term outcomes.


Subject(s)
Carotid Stenosis/therapy , Endovascular Procedures/instrumentation , Stents , Aged , California , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/mortality , Carotid Stenosis/physiopathology , Colorado , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Male , Recurrence , Retreatment , Retrospective Studies , Risk Factors , Stroke/mortality , Time Factors , Treatment Outcome
20.
Catheter Cardiovasc Interv ; 94(1): 165-170, 2019 07 01.
Article in English | MEDLINE | ID: mdl-30588751

ABSTRACT

OBJECTIVES: This study investigates the correlation of occlusive wedge pressure (WP) with direct left atrial (LA) pressure in patients with severe mitral regurgitation (MR) undergoing transcatheter mitral valve repair (TMVr) with MitraClip. BACKGROUND: There is interest in acquiring objective hemodynamic parameters for intraprocedural guidance in patients undergoing MitraClip. METHODS: The study included 94 patients with severe MR at prohibitive surgical risk who underwent MitraClip at the University of California Davis Medical Center between 2014 and 2016. RESULTS: An average of 1.8 ± 0.7 clips were used to achieve MR grade of 2+ or less in 99% of patients. Correlation analysis of all (n = 236) pre-clip, inter-clip, and final-clip WP and LA pressures yielded a Pearson's R (r) of 0.85 and 0.79 for mean WP vs mean LA and WP V vs LA V, respectively. Median LA V to mean LA ratio (LAV:mLA) was 1.75 (IQR 1.5-1.9). 79% (n = 74) of patients had LAV:mLA ratio ≥ 1.5 with associated WP V vs LA V correlation (r) of 0.83. In patients with LAV:mLA ratio < 1.5, the correlation (r) was 0.69. Baseline characteristics were not significantly different between patients with LAV:mLA ratio ≥ 1.5 and patients with LAV:mLA ratio < 1.5. Post-procedure, median LA V: mean LA ratio decreased from 1.75 to 1.4, P = 0.0001. CONCLUSIONS: Correlation between WP and direct LA pressure in patients with severe MR undergoing Mitraclip is modest. Caution is advised when using WP to approximate LA pressure intraprocedurally, especially in patients with baseline low LAV:mLA ratios.


Subject(s)
Atrial Function, Left , Atrial Pressure , Cardiac Catheterization , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency/surgery , Mitral Valve/surgery , Monitoring, Intraoperative , Pulmonary Wedge Pressure , Aged , Aged, 80 and over , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Female , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/instrumentation , Humans , Male , Mitral Valve/diagnostic imaging , Mitral Valve/physiopathology , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/physiopathology , Prosthesis Design , Registries , Retrospective Studies , Severity of Illness Index , Time Factors , Treatment Outcome
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