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1.
J Card Fail ; 30(7): 952-957, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38458486

ABSTRACT

BACKGROUND: Cardiogenic shock (CS) is complicated by high mortality rates. Targeted temperature control (TTC) has been proposed as an adjunct therapy in CS. This study aims to examine the safety of TTC in patients presenting with CS. METHODS AND RESULTS: In this open-label, randomized controlled pilot trial, 20 patients with hemodynamic criteria for CS were assigned to standard of care plus TTC vs standard of care alone. The primary outcome was a composite safety outcome, including well-described complications of TTC. Secondary outcomes included mortality at 90 days, invasive hemodynamic and echocardiographic parameters, electrocardiographic measurements, and inotrope dosing. There were no significant differences in the composite analysis of prespecified safety outcomes (3 events in the TTC group vs 0 events in the control group; P = 0.24). Patients randomized to TTC demonstrated a statistically significant increase in cardiac index and cardiac power index compared to the control group at 48-96 hours after randomization (3.6 [3.1, 3.9] L/min/m2 vs 2.6 [2.5, 3.15] L/min/m2; P = 0.029 and 0.61 [0.55, 0.7] W/m2 vs 0.53 [0.435, 0.565] W/m2; P = 0.029, respectively). CONCLUSION: TTC may be a safe adjunct therapy for patients presenting with CS and may yield improvement in specific hemodynamic parameters.


Subject(s)
Hypothermia, Induced , Shock, Cardiogenic , Humans , Shock, Cardiogenic/therapy , Shock, Cardiogenic/physiopathology , Shock, Cardiogenic/mortality , Male , Female , Aged , Pilot Projects , Middle Aged , Hypothermia, Induced/methods , Treatment Outcome , Hemodynamics/physiology
2.
Catheter Cardiovasc Interv ; 99(4): 1165-1171, 2022 03.
Article in English | MEDLINE | ID: mdl-34837459

ABSTRACT

Health care practices are influenced by variety of factors. These factors that include social determinants, race and ethnicity, and gender not only affect access to health care but can also affect quality of care and patient outcomes. These are a source of health care disparities. This article acknowledges that these disparities exist in getting optimal care in structural heart disease, reviews the literature and proposes steps that can help reduce these disparities on personal and committee levels.


Subject(s)
Cardiology , Health Equity , Heart Diseases , Healthcare Disparities , Heart Diseases/diagnostic imaging , Heart Diseases/therapy , Humans , Treatment Outcome
3.
Vasc Med ; 26(2): 195-199, 2021 04.
Article in English | MEDLINE | ID: mdl-33507844

ABSTRACT

Previous studies on everolimus-eluting bioresorbable vascular scaffolds (BVS) have shown promising 1-year primary patency rates in infrapopliteal arteries. Literature from large cohorts on long-term outcomes with the infrapopliteal Absorb BVS (Abbott Vascular) is lacking. The aim of this study is to pool published and unpublished data to provide a more precise estimate of the 24-month outcomes of Absorb BVS for the treatment of infrapopliteal disease. For the pooled analysis, updated original and newly collected data from three cohorts on treatment with the Absorb BVS for de novo infrapopliteal lesions were combined. The primary endpoint was freedom from restenosis. Secondary endpoints were freedom from clinically driven target lesion revascularization (CD-TLR), major amputation and survival. The pooled analysis included a total of 121 patients with 161 lesions, treated with 189 Absorb BVS in 126 limbs. The mean age of the patients was 73 years, 57% had diabetes mellitus, and 75% were classified as Rutherford-Becker class 5 or 6. Of the 161 lesions, 101 (63%) were calcified and 36 (22%) were occlusions. Successful deployment was achieved with all scaffolds. Freedom from restenosis was 91.7% and 86.6% at 12 and 24 months, respectively, and freedom from CD-TLR was 97.2% and 96.6%. Major amputation occurred in 1.6% of the limbs. Overall survival was 85% at 24 months. In conclusion, this pooled analysis represents the largest reported analysis of mid-term results of the Absorb BVS for the management of chronic limb-threatening ischemia. At 24 months, the Absorb BVS was safe with promising clinical outcomes for the treatment of infrapopliteal disease.


Subject(s)
Coronary Artery Disease , Everolimus , Peripheral Arterial Disease , Absorbable Implants , Aged , Everolimus/administration & dosage , Humans , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Popliteal Artery/diagnostic imaging , Prosthesis Design , Treatment Outcome , Vascular Patency
4.
Vascular ; 29(3): 355-362, 2021 Jun.
Article in English | MEDLINE | ID: mdl-32921290

ABSTRACT

OBJECTIVES: To assess the safety, efficacy, and durability of the Absorb bioresorbable vascular scaffold in predominantly complex, infra-popliteal lesions for the management of chronic limb ischemia at two-year clinical follow-up. Bioresorbable vascular scaffold are biodegradable scaffolds that provide short-term vascular support before undergoing intravascular degradation. A recent trial reported excellent 36-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb bioresorbable vascular scaffold. METHODS: This single-center, retrospective study evaluated the use of the Absorb bioresorbable vascular scaffold (everolimus impregnated poly-L-lactic scaffold) in patients with infra-popliteal peripheral arterial disease (PAD) with respect to safety (thrombosis and TIMI bleeding), technical success, and freedom from clinically driven target vessel failure at 24 months. RESULTS: 31 patients (51.6% male) with a median age of 67 years with predominantly advanced infra-popliteal disease were treated with 49 bioresorbable vascular scaffold in 41 vessels. The mean stenosis was 94% (80-100), with 49% of lesions being chronic thrombotic occlusions. No scaffold thrombosis or peri-procedural bleeding was observed. Procedural success was achieved in all patients; 93.5% of patients experienced freedom from clinically driven target vessel failure at 24 months, driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months and 87.1% at 24 months. All patients were alive at 12 and 24 months. CONCLUSIONS: At 24 months, our study found that patients with predominantly advanced infra-popliteal PAD who were treated with Absorb bioresorbable vascular scaffold reported improved clinical status and a low and durable rate of clinically driven target vessel failure extending out to 24 months.


Subject(s)
Absorbable Implants , Angioplasty, Balloon/instrumentation , Ischemia/therapy , Peripheral Arterial Disease/therapy , Popliteal Artery , Aged , Aged, 80 and over , Amputation, Surgical , Angioplasty, Balloon/adverse effects , Female , Humans , Ischemia/diagnostic imaging , Ischemia/physiopathology , Limb Salvage , Male , Middle Aged , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Popliteal Artery/diagnostic imaging , Popliteal Artery/physiopathology , Retrospective Studies , Time Factors , Treatment Outcome , Vascular Patency
5.
Exp Physiol ; 104(9): 1343-1352, 2019 09.
Article in English | MEDLINE | ID: mdl-31264265

ABSTRACT

NEW FINDINGS: What is the central question of this study? Are circulating monocyte markers correlated with their derived macrophage polarization patterns and coronary artery disease severity? What is the main finding and its importance? There was an inverse relationship between circulating CD16+ monocytes (high) and M2 macrophages (low) that marked coronary disease severity, and the differences in polarization of macrophages were seen despite a week of cell culture ex vivo. This study highlights the importance, and potential prognostic implications, of circulating monocyte and descendant macrophage phenotypes in coronary artery disease. ABSTRACT: Monocytes and macrophages are central to atherosclerosis, but how they combine to mark progression of human coronary artery disease (CAD) is unclear. We tested whether patients' monocyte subtypes paired with their derived macrophage profiles were correlated with extent of CAD. Peripheral blood was collected from 40 patients undergoing cardiac catheterization, and patients were categorized as having no significant CAD, single vessel disease or multivessel disease according to the number of affected coronary arteries. Mononuclear cells were measured for the monocyte markers CD14 and CD16 by flow cytometry, and separate monocytes were cultured into macrophages over 7 days and measured for the polarization markers CD86 and CD206. At baseline, patients with a greater CAD burden were older, with higher rates of statin, ß-blocker and antiplatelet drug use, whereas other characteristics were similar across the spectrum of coronary disease. CD16+ (both intermediate and non-classical) monocytes were elevated in patients with single vessel and multivessel disease compared with those without significant CAD (P < 0.05), whereas regulatory M2 macrophages (CD206+ ) were decreased in patients with single vessel and multivessel disease (P < 0.001). An inverse relationship between paired CD16+ monocytes and M2 macrophages marked CAD severity. On multivariable linear regression, CAD severity was associated, along with age and traditional cardiovascular risk factors, with CD16+ monocytes (directly) and M2 macrophages (inversely). Circulating monocytes may influence downstream polarization of lesional macrophages, and these measures of monocyte and macrophage subtypes hold potential as biomarkers in CAD.


Subject(s)
Biomarkers/metabolism , Coronary Artery Disease/metabolism , Macrophages/metabolism , Monocytes/metabolism , Aged , Antigens, CD/metabolism , Female , Humans , Male , Middle Aged
6.
Catheter Cardiovasc Interv ; 93(7): 1228-1235, 2019 06 01.
Article in English | MEDLINE | ID: mdl-30393942

ABSTRACT

OBJECTIVE: To evaluate contrast media (CM) volume (CMV) saved using the DyeVert™ Plus Contrast Reduction System (DyeVert Plus System, Osprey Medical) in patients undergoing diagnostic coronary angiogram (CAG) and/or percutaneous coronary interventional (PCI) procedures performed with manual injections. BACKGROUND: Current guidelines advocate for monitoring and minimization of the total volume of CM in chronic kidney disease (CKD) patients undergoing invasive cardiac procedures. The DyeVert Plus System is an FDA cleared device designed to reduce CMV delivered during angiography and permit real-time CMV monitoring. METHODS: We performed a multicenter, single-arm, observational study. Eligible subjects were ≥ 18 years old with baseline estimated glomerular filtration rate (eGFR) 20-60 mL/min/1.73 m2 . The primary endpoint was % CMV saved over the total procedure. A secondary objective was to evaluate adverse events (AEs) related to DyeVert Plus System or to CM use. RESULTS: A total of 114 subjects were enrolled at eight centers. Mean age was 72 ± 9 years, 72% were male, and mean body mass index was 29 ± 5. Baseline eGFR was 43 ± 11 mL/min/1.73 m2 . CAG-only was performed in 65% of cases. One hundred and five subjects were evaluable for the primary endpoint. Mean CMV attempted was 112 ± 85 mL (range 22-681) and mean CMV delivered was 67 ± 51 mL (range 12-403), resulting in an overall CMV savings of 40.1 ± 8.8% (95% CI 38.4, 41.8; P < 0.0001) per procedure. Image quality was maintained in all but one case where the system was turned off for one injection. No DyeVert Plus System-related AEs were reported. Acute kidney injury (AKI; defined as serum creatinine rise of >0.3 mg/dL from baseline) was reported in 11 cases with seven occurring in subjects with baseline eGFR < 30 and three AKI events were attributed to CM. AKI rates increased as CMV/eGFR ratios increased. CONCLUSIONS: These data suggest DyeVert Plus System use in CKD patients undergoing CAG and/or PCI results in clinically meaningful CMV savings while maintaining image quality.


Subject(s)
Acute Kidney Injury/prevention & control , Contrast Media/administration & dosage , Coronary Angiography/instrumentation , Coronary Artery Disease/diagnostic imaging , Glomerular Filtration Rate , Kidney/drug effects , Acute Kidney Injury/chemically induced , Acute Kidney Injury/diagnostic imaging , Acute Kidney Injury/physiopathology , Aged , Aged, 80 and over , Contrast Media/adverse effects , Coronary Angiography/adverse effects , Coronary Artery Disease/complications , Coronary Artery Disease/therapy , Equipment Design , Female , Humans , Kidney/physiopathology , Male , Middle Aged , Percutaneous Coronary Intervention , Predictive Value of Tests , Prospective Studies , Protective Factors , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/diagnosis , Renal Insufficiency, Chronic/physiopathology , Risk Factors , Treatment Outcome , United States
7.
Catheter Cardiovasc Interv ; 94(7): 1028-1033, 2019 Dec 01.
Article in English | MEDLINE | ID: mdl-31617294

ABSTRACT

OBJECTIVES: To assess the safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) in complex, infrapopliteal lesions for the management of chronic limb ischemia. BACKGROUND: The interventional management of infrapopliteal PAD remains challenging due to high restenosis rates with metallic drug-eluting stents and balloon angioplasty. Metallic stents are associated with impaired vessel vasomotor tone, remodeling, autoregulation, and long-term inflammation. BVSs are biodegradable scaffolds that provide short-term vascular support before degrading to allow restoration of vasomotor tone and endothelial function. A recent trial reported excellent 12-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb BVS. METHODS: This single-center, retrospective study evaluated the use of the Absorb BVS (everolimus impregnated poly-L-lactic scaffold) in patients with infrapopliteal PAD with respect to safety (thrombosis and TIMI bleeding), technical success, and clinically driven target vessel failure (CD-TVF) at 12 months. RESULTS: Thirty-one patients (51.6% male) with a median age of 67 years with advanced infrapopliteal disease were treated with 49 BVS in 41 vessels. The mean stenosis was 94% (80-100), with 49% of lesions being CTOs. No scaffold thrombosis or periprocedural bleeding was observed. Procedural success was achieved in all patients. Freedom from CD-TVF was 95.1% at 12 months driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months. All patients were alive at 12 months, and 96.8% of patients improved their Rutherford-Becker classification. CONCLUSIONS: At 12 months, our study found that patients with advanced infrapopliteal PAD who were treated with Absorb BVS reported improved clinical status and a low rate of CD-TVF.


Subject(s)
Absorbable Implants , Angioplasty, Balloon/instrumentation , Ischemia/therapy , Peripheral Arterial Disease/therapy , Popliteal Artery , Aged , Angioplasty, Balloon/adverse effects , Chronic Disease , Databases, Factual , Female , Humans , Ischemia/diagnostic imaging , Ischemia/physiopathology , Male , Middle Aged , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Popliteal Artery/diagnostic imaging , Popliteal Artery/physiopathology , Prosthesis Design , Retrospective Studies , Risk Factors , Severity of Illness Index , Time Factors , Treatment Outcome , Vascular Patency
8.
Am J Physiol Heart Circ Physiol ; 314(5): H1033-H1042, 2018 05 01.
Article in English | MEDLINE | ID: mdl-29424571

ABSTRACT

There are multiple proposed mechanisms for the pathophysiology of heart failure (HF) with preserved ejection fraction (HFpEF). We hypothesized that coronary microvascular dysfunction is common in these patients. In a prospective, observational study, patients undergoing cardiac catheterization with HFpEF [left ventricular (LV) ejection fraction ≥ 50% and with clinical HF] were compared with similar patients without HFpEF. Patients with ≥50% stenosis were excluded, and coronary flow reserve (CFR) and the index of microvascular resistance (IMR) were measured after adenosine administration using a guidewire, with CFR ≤ 2 and IMR ≥ 23 being abnormal. Baseline characteristics and CFR and IMR were compared in 30 HFpEF patients and 14 control subjects. Compared with control subjects, HFpEF patients were older (65.4 ± 9.6 vs. 55.1 ± 3.1 yr, P < 0.01), had higher numbers of comorbidities (4.4 ± 1.5 vs. 2.6 ± 1.9, P = 0.002), had higher median B-type natriuretic peptide [161 (interquartile range: 75-511) pg/dl vs. 37 (interquartile range: 18.5-111) pg/dl, P < 0.01], and had higher LV end-diastolic pressure (17.8 ± 4.2 vs. 8.4 ± 4.2, P < 0.01). HFpEF patients had lower CFR (2.55 ± 1.60 vs. 3.84 ± 1.89, P = 0.024) and higher IMR (26.7 ± 10.3 vs. 19.7 ± 9.7 units, P = 0.037) than control subjects. Most (71.4%) control subjects had normal coronary physiology, whereas 36.7% of HFpEF patients had both abnormal CFR and IMR and another 36.7% had either abnormal CFR or IMR. In conclusion, this is the first study that has reported invasively determined CFR and IMR in HFpEF patients. We demonstrated the presence of four distinct coronary physiology groups in HFpEF patients. Investigation into the potential mechanisms for these findings is needed. NEW & NOTEWORTHY In this prospective observational study of patients with heart failure with preserved ejection fraction (HFpEF), we found that patients with HFpEF had more abnormalities of coronary flow and resistance than asymptomatic control patients, indicating that coronary microvascular dysfunction may play a role in the HFpEF disease process.


Subject(s)
Coronary Circulation , Coronary Vessels/physiopathology , Heart Failure/physiopathology , Microcirculation , Microvessels/physiopathology , Stroke Volume , Ventricular Function, Left , Aged , Case-Control Studies , Coronary Vessels/diagnostic imaging , Female , Heart Failure/diagnostic imaging , Humans , Illinois , Male , Microvessels/diagnostic imaging , Middle Aged , Prospective Studies , Vascular Resistance
9.
Catheter Cardiovasc Interv ; 92(2): 366-371, 2018 08 01.
Article in English | MEDLINE | ID: mdl-29745451

ABSTRACT

OBJECTIVE: To determine if the cardiac arrest triage (CART) Score would better predict poor outcomes after pharmacomechanical therapy (PMT) for massive and submassive pulmonary embolism (PE) than traditional risk scores BACKGROUND: PMT for massive and submassive PE allows for clot lysis with minimal doses of fibrinolytics. Although PMT results in improved right ventricular function, and reduced pulmonary pressures and thrombus burden, predictors of poor outcome are not well-studied. METHODS: We conducted a retrospective analysis of all patients who underwent PMT for massive or submassive PE at a single institution from 2010 to 2016. The CART score and electronic CART (eCART) score, derived previously as early warning scores for hospitalized patients, were compared to pulmonary embolism severity index (PESI) comparing the area under the receiver-operator characteristic curve (AUC) for predicting 30-day mortality. RESULTS: We studied 61 patients (56 ±17 years, 44.0% male, 29.5% massive PE, mean PESI 114.6 ± 42.7, mean CART 13.5 ± 1.39, mean eCART 108.5 ± 28.6). Thirty-day mortality was 24.6%. Treatments included rheolytic thrombectomy (32.7%), catheter-directed thrombolysis (50.8%), ultrasound-assisted thrombolysis (32.7%), and mechanical thrombectomy (4.9%). There were no differences in outcome based on technique. The eCART and CART scores had higher AUCs compared to PESI in predicting 30-day mortality (0.84 vs 0.72 vs 0.69, P = .010). We found troponin I and pro-BNP were higher in higher eCART tertiles, however AUCs were 0.51 and 0.63, respectively for 30-day mortality when used as stand-alone predictors. CONCLUSION: Compared to PESI score, CART and eCART scores better predict mortality in massive or submassive PE patients undergoing PMT.


Subject(s)
Decision Support Techniques , Fibrinolytic Agents/administration & dosage , Heart Arrest/mortality , Pulmonary Embolism/drug therapy , Thrombolytic Therapy/mortality , Triage/methods , Adult , Aged , Female , Fibrinolytic Agents/adverse effects , Health Status , Heart Arrest/diagnosis , Heart Arrest/etiology , Humans , Male , Middle Aged , Predictive Value of Tests , Pulmonary Embolism/complications , Pulmonary Embolism/diagnostic imaging , Pulmonary Embolism/mortality , Reproducibility of Results , Retrospective Studies , Risk Assessment , Risk Factors , Severity of Illness Index , Thrombolytic Therapy/adverse effects , Thrombolytic Therapy/methods , Time Factors , Treatment Outcome
10.
Echocardiography ; 34(5): 690-699, 2017 May.
Article in English | MEDLINE | ID: mdl-28345211

ABSTRACT

BACKGROUND: With the increasing use of transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis (AS), computed tomography (CT) remains the standard for annulus sizing. However, 3D transesophageal echocardiography (TEE) has been an alternative in patients with contraindications to CT. We sought to (1) test the feasibility, accuracy, and reproducibility of prototype 3DTEE analysis software (Philips) for aortic annular measurements and (2) compare the new approach to the existing echocardiographic techniques. METHODS: We prospectively studied 52 patients who underwent gated contrast CT, procedural 3DTEE, and TAVR. 3DTEE images were analyzed using novel semi-automated software designed for 3D measurements of the aortic root, which uses multiplanar reconstruction, similar to CT analysis. Aortic annulus measurements included area, perimeter, and diameter calculations from these measurements. The results were compared to CT-derived values. Additionally, 3D echocardiographic measurements (3D planimetry and mitral valve analysis software adapted for the aortic valve) were also compared to the CT reference values. RESULTS: 3DTEE image quality was sufficient in 90% of patients for aortic annulus measurements using the new software, which were in good agreement with CT (r-values: .89-.91) and small (<4%) inter-modality nonsignificant biases. Repeated measurements showed <10% measurements variability. The new 3D analysis was the more accurate and reproducible of the existing echocardiographic techniques. CONCLUSIONS: Novel semi-automated 3DTEE analysis software can accurately measure aortic annulus in patients with severe AS undergoing TAVR, in better agreement with CT than the existing methodology. Accordingly, intra-procedural TEE could potentially replace CT in patients where CT carries significant risk.


Subject(s)
Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/therapy , Aortic Valve/diagnostic imaging , Echocardiography, Three-Dimensional/methods , Image Interpretation, Computer-Assisted/methods , Software , Transcatheter Aortic Valve Replacement/methods , Aged, 80 and over , Algorithms , Aorta/diagnostic imaging , Aorta/surgery , Aortic Valve/surgery , Female , Humans , Image Enhancement/methods , Male , Prosthesis Fitting/methods , Reproducibility of Results , Sensitivity and Specificity , Tomography, X-Ray Computed/methods , Treatment Outcome
11.
Catheter Cardiovasc Interv ; 87(5): 971-9, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26527571

ABSTRACT

OBJECTIVE: This study sought to assess the long-term clinical benefits and predictors of survival of trans-catheter aortic valve closure in left ventricular assist device (LVAD) patients. BACKGROUND: LVADs have been shown to increase survival and quality of life in patients with end-stage heart failure. However, severe aortic insufficiency (AI) can develop in up to 50% of patients at 12 months resulting in significant morbidity and mortality. Trans-catheter treatment of LVAD associated AI has emerged as a potential alternative to surgical treatment. METHODS: We conducted a retrospective analysis of all patients undergoing trans-catheter aortic valve closure using an Amplatzer Multi-Fenestrated Septal Occluder "Cribriform" device to assess potential clinical and procedural factors associated with survival. Student's t-tests were used to compare baseline patient demographics and procedural characteristics, as well as patient outcomes immediately post procedure and at 6 months. A P-value of less than 0.05 was considered statistically significant. RESULTS: A total of 10 patients (70% male, median age 59 years) were included. Technical success was accomplished in 100% of patients with a 6 month survival rate of 30% (3/10). Compared with survivors, non-survivors had a higher rate of pre-procedural clinical co-morbidities, an increased likelihood of right ventricular failure, and received larger occluder devices. CONCLUSIONS: Trans-catheter aortic valve closure successfully treats late severe AI in LVAD patients, however, the presence or development of right heart failure portends a worse prognosis. Further studies are needed to investigate the factors involved in the development of right ventricular failure, and potential treatment, in patients undergoing trans-catheter aortic valve closure.


Subject(s)
Aortic Valve Insufficiency/therapy , Cardiac Catheterization , Heart Failure/therapy , Heart-Assist Devices/adverse effects , Ventricular Function, Left , Adult , Aged , Aortic Valve Insufficiency/diagnostic imaging , Aortic Valve Insufficiency/etiology , Aortic Valve Insufficiency/mortality , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Cardiac Catheterization/mortality , Comorbidity , Echocardiography, Doppler, Color , Echocardiography, Three-Dimensional , Echocardiography, Transesophageal , Female , Heart Failure/diagnostic imaging , Heart Failure/mortality , Heart Failure/physiopathology , Humans , Male , Middle Aged , Prosthesis Design , Retrospective Studies , Risk Factors , Septal Occluder Device , Severity of Illness Index , Time Factors , Treatment Outcome
13.
Catheter Cardiovasc Interv ; 86(3): 472-5, 2015 Sep.
Article in English | MEDLINE | ID: mdl-25708733

ABSTRACT

Vascular fistulae are frequent complications in patients who have undergone a Fontan operation for palliation of single ventricle physiology. Fistulae involving the pulmonary vasculature may result in progressive hypoxemia, pulmonary hemorrhage, and clinical symptoms. These are commonly managed by percutaneous transcatheter embolization utilizing coils, and more recently, vascular plugs and septal occluders. We present a clinical case of an adult patient who underwent an extracardiac Fontan procedure in childhood for univentricular physiology and presented with symptoms of systemic desaturation 10 years after his surgery. The patient was found to have a large fistula from the inferior vena cava to the right inferior pulmonary vein. The fistula was attempted to be closed with a 12 mm Amplatzer Septal Occluder (St. Jude Medical, St. Paul, MN). Angiography showed continued flow across the fistula, which was then successfully occluded with an 18 mm Amplatzer "Cribriform" Septal Occluder (St. Jude Medical, St. Paul, MN). The patient experienced immediate improvement in his systemic saturation, and demonstrates continued resolution of his symptomatic hypoxia on follow-up. This case illustrates an uncommon systemic to pulmonary vein fistula after Fontan, and a unique, successful embolization with two septal occluders, resulting in sustained symptomatic improvement.


Subject(s)
Cardiac Catheterization/methods , Embolization, Therapeutic/methods , Fontan Procedure/adverse effects , Heart Defects, Congenital/surgery , Pulmonary Veins/injuries , Vascular Fistula/etiology , Vascular Fistula/therapy , Coronary Angiography , Humans , Male , Septal Occluder Device , Young Adult
14.
Catheter Cardiovasc Interv ; 85(1): 161-5, 2015 Jan 01.
Article in English | MEDLINE | ID: mdl-25176592

ABSTRACT

Iatrogenic membranous ventricular septal defects (VSD) are rare complications of cardiothoracic surgery, most commonly seen as a complication of aortic valve replacements. An iatrogenic VSD can lead to right sided heart failure, systemic hypoxia, and arrhythmias, and closure is often necessary. Given the increased mortality associated with repeat surgical procedures, percutaneous transcatheter closure of these iatrogenic VSDs has increasingly become the preferred choice of therapy. We describe the first case of iatrogenic membranous VSD in the setting of mitral valve replacement and tricuspid valve repair, using the newly approved Amplatzer Duct Occluder II Device from an entirely retrograde approach. © 2014 Wiley Periodicals, Inc.


Subject(s)
Cardiac Catheterization , Heart Injuries/therapy , Heart Valve Prosthesis Implantation/adverse effects , Iatrogenic Disease , Ventricular Septum/injuries , Aged , Cardiac Catheterization/instrumentation , Echocardiography, Doppler, Color , Heart Injuries/diagnosis , Heart Injuries/etiology , Humans , Male , Prosthesis Design , Septal Occluder Device , Tomography, X-Ray Computed , Treatment Outcome
16.
Heart Rhythm ; 2024 May 18.
Article in English | MEDLINE | ID: mdl-38768843

ABSTRACT

BACKGROUND: Although expertise in left atrial appendage occlusion (LAAO) has grown, certain intricate anatomies may pose challenges, rendering them unsuitable for LAAO with the selected device. OBJECTIVE: This analysis aimed to characterize outcomes of patients with prior failed percutaneous LAAO procedures who underwent a subsequent attempt with an Amulet occluder in the EMERGE LAA postapproval study. METHODS: Patients enrolled in the National Cardiovascular Data Registry LAAO Registry who had an Amulet occluder implantation attempt between Food and Drug Administration approval (August 14, 2021) and June 30, 2023, were evaluated. A safety end point through 7 days or hospital discharge (whichever was later) and major adverse events through 45 days were reported. RESULTS: A total of 8591 patients underwent attempted Amulet occluder implantation, of whom 244 patients had prior failed LAAO. Implantation success was 88.9% and 96.2% in patients with prior failed LAAO and index LAAO, respectively (P < .001). The safety composite end point was low, occurring in 1.6% and 0.8% of patients with prior failed LAAO and index LAAO, respectively (P = .148). Any major adverse event through 45 days occurred in 7.4% and 6.3% of prior failed LAAO and index LAAO patient cohorts, respectively (P = .497); most adverse events were similar between the groups (P > .05). At 45 days, peridevice leak ≤3 mm was achieved in >90% of patients in either group. CONCLUSION: A high degree of implantation success with a low rate of adverse events can be achieved with the Amulet occluder. The findings imply that the dual occlusive mechanism Amulet occluder facilitates successful closure, even in challenging anatomic scenarios.

17.
Article in English | MEDLINE | ID: mdl-38310499

ABSTRACT

BACKGROUND: The Food and Drug Administration approved the Amulet occluder (Abbott) after demonstrating safety and effectiveness in the Amulet IDE (AMPLATZER Amulet LAA Occluder) trial. OBJECTIVES: The aim of the EMERGE Left Atrial Appendage study is to evaluate early postapproval outcomes of the Amulet occluder in the United States using data from the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry. METHODS: Patients with a commercial Amulet occluder implant attempt between Food and Drug Administration approval (August 14, 2021) and December 31, 2022, were included. The safety composite endpoint included all-cause death, ischemic stroke, systemic embolism, or device/procedure-related events requiring open cardiac surgery or endovascular intervention between device implantation and 7 days or hospital discharge (whichever is later). Major adverse events through 45 days were also reported and stratified by operator experience (early [<10 cases], moderate [10-29 cases], and high [30+ cases]). RESULTS: A total of 5,499 patients underwent attempted Amulet occluder implantation. Implant success was 95.8%, and complete closure was 97.2% post-left atrial appendage occlusion and 87.1% at 45 days. A safety composite endpoint event occurred in 0.76% patients. Any major adverse event occurred in 2.9% and 5.7% of patients in-hospital and through 45 days, respectively, driven by major bleeding and pericardial effusion (PE) requiring intervention. PE requiring surgery or percutaneous intervention decreased significantly with increasing experience both in-hospital (early vs high operator experience 1.8% vs 1.1%; P = 0.006) and at 45 days (2.3% vs 1.5%; P = 0.012). CONCLUSIONS: The EMERGE Left Atrial Appendage study demonstrates favorable safety and effectiveness of the Amulet occluder in the real-world setting. More experienced operators had improved implant success and fewer PEs, suggesting a learning curve effect implanting this dual occlusive mechanism device.

18.
JACC Cardiovasc Interv ; 17(7): 920-929, 2024 Apr 08.
Article in English | MEDLINE | ID: mdl-38599696

ABSTRACT

BACKGROUND: Ischemia with no obstructive coronary arteries is frequently caused by coronary microvascular dysfunction (CMD). Consensus diagnostic criteria for CMD include baseline angiographic slow flow by corrected TIMI (Thrombolysis In Myocardial Infarction) frame count (cTFC), but correlations between slow flow and CMD measured by invasive coronary function testing (CFT) are uncertain. OBJECTIVES: The aim of this study was to investigate relationships between cTFC and invasive CFT for CMD. METHODS: Adults with ischemia with no obstructive coronary arteries underwent invasive CFT with thermodilution-derived baseline coronary blood flow, coronary flow reserve (CFR), and index of microcirculatory resistance (IMR). CMD was defined as abnormal CFR (<2.5) and/or abnormal IMR (≥25). cTFC was measured from baseline angiography; slow flow was defined as cTFC >25. Correlations between cTFC and baseline coronary flow and between CFR and IMR and associations between slow flow and invasive measures of CMD were evaluated, adjusted for covariates. All patients provided consent. RESULTS: Among 508 adults, 49% had coronary slow flow. Patients with slow flow were more likely to have abnormal IMR (36% vs 26%; P = 0.019) but less likely to have abnormal CFR (28% vs 42%; P = 0.001), with no difference in CMD (46% vs 51%). cTFC was weakly correlated with baseline coronary blood flow (r = -0.35; 95% CI: -0.42 to -0.27), CFR (r = 0.20; 95% CI: 0.12 to 0.28), and IMR (r = 0.16; 95% CI: 0.07-0.24). In multivariable models, slow flow was associated with lower odds of abnormal CFR (adjusted OR: 0.53; 95% CI: 0.35 to 0.80). CONCLUSIONS: Coronary slow flow was weakly associated with results of invasive CFT and should not be used as a surrogate for the invasive diagnosis of CMD.


Subject(s)
Coronary Artery Disease , Cysteine/analogs & derivatives , Myocardial Infarction , Myocardial Ischemia , Adult , Humans , Microcirculation/physiology , Vascular Resistance/physiology , Treatment Outcome , Coronary Vessels/diagnostic imaging , Coronary Circulation/physiology , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy
19.
J Neurointerv Surg ; 2024 Jan 03.
Article in English | MEDLINE | ID: mdl-38171608

ABSTRACT

BACKGROUND: The use of covered stent grafts for the treatment of carotid rupture is increasingly being used given their ability to preserve the parent artery while simultaneously occluding the fistula or rupture point. METHODS: This case series describes the technical feasibility of using, and the performance of, the PK Papyrus covered coronary stent (Biotronik, Inc., Lake Oswego, Oregon, USA) in six patients with carotid rupture, including carotid cavernous fistulas, between July 2021 and October 2023 in a single-center institution in the USA. RESULTS: The median decade of life was 5 (IQR 3) with a 1:1 male-to-female ratio. The majority were black patients (n=5/6, 83.3%). The most common disease pathology was carotid cavernous fistula (n=4/6, 66.7%), followed by traumatic carotid rupture (n=2/6, 33.3%). All the stent embolization procedures were successfully treated with the PK Papyrus covered coronary stent. None of the patients had any recurrence or re-treatment. The number of stents required ranged from 1 to 3. A balloon guide catheter was used in 66.7% of cases (n=4/6). In-hospital mortality was 0.0% (n=0/6). No in-stent thrombosis was observed, but there was one case of cangrelor-associated hemorrhagic stroke conversion. Transfemoral access was used in all cases with one access site complication. Median follow-up time was 1.8 months (IQR 3.5). CONCLUSIONS: To our knowledge, this is the largest case series in the USA demonstrating the feasibility and safety of using the PK Papyrus covered coronary stent for the treatment of carotid rupture, including carotid cavernous fistulas.

20.
Echocardiography ; 30(6): E148-51, 2013 Jul.
Article in English | MEDLINE | ID: mdl-23551839

ABSTRACT

An elderly man with dyspnea and syncope was found to have severe aortic stenosis (AS) by the continuity equation, despite a transaortic gradient that was only moderately elevated, in the setting of severe left ventricular dysfunction. The transaortic gradient increased during postextrasystolic beats, suggesting that his that his AS was truly severe; this was confirmed by dobutamine echocardiography. He underwent transcatheter aortic-valve replacement (TAVR), with subsequent improvement in left ventricular systolic function. The diagnostic and prognostic significance of postextrasystolic potentiation, with associated increase in aortic stenosis gradient, deserves renewed attention in the TAVR era.


Subject(s)
Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Dobutamine , Echocardiography/methods , Exercise Test/methods , Heart Valve Prosthesis Implantation , Aged, 80 and over , Humans , Male , Preoperative Care/methods , Prognosis , Treatment Outcome , Vasodilator Agents
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