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1.
Dermatol Ther ; 35(2): e15231, 2022 02.
Article in English | MEDLINE | ID: mdl-34820971

ABSTRACT

Data on the effectiveness and safety of a drug in real-world clinical practice complement the evidence from clinical trials, which are carried out in a different setting. Little has been published on the effectiveness and safety of guselkumab in the treatment of psoriasis in clinical practice. The ojective of this study was to assess the effectiveness and safety of guselkumab at 24 weeks in patients with moderate to severe plaque psoriasis in routine clinical practice. A retrospective, multicentre study of adult patients with moderate to severe plaque psoriasis treated with guselkumab for at least 24 weeks was carried out in Spain. We studied 343 patients, 249 of whom were followed for 24 weeks. By week 24, the mean (SD) psoriasis area severity index (PASI) had decreased from 11.1 (7.3) to 1.7 (2.8) (-9.3; [-10.2;-8.4]), 85.9% of the patients had achieved PASI score of 4 or less and 77.9% a PASI score of 2 or less. In terms of relative PASI response, 59.4% of the patients achieved a PASI-90 response and 49.0% a PASI-100 response. On multivariate analysis, two factors reduced the probability of a PASI of 2 or less at 24 weeks: a BMI ≥30 (OR, 0.44; 95% CI, 0.22-0.88) and a greater previous exposure to biologic therapy (OR, 0.69; 95% CI, [0.56-0.84]). Adverse events were rare (9.9%) and led to withdrawal from treatment in only nine patients (2.6%) by the end of the follow-up period. The results of this study confirm the high efficacy and safety of guselkumab indicated by the clinical trial data. In clinical practice, the absolute PASI score appears to be a better marker of response to treatment than the relative value.


Subject(s)
Psoriasis , Adult , Antibodies, Monoclonal, Humanized , Humans , Psoriasis/diagnosis , Psoriasis/drug therapy , Retrospective Studies , Severity of Illness Index , Treatment Outcome
2.
Dermatol Ther ; 35(2): e15229, 2022 02.
Article in English | MEDLINE | ID: mdl-34820974

ABSTRACT

Carboxytherapy has been used in the treatment of autoimmune skin diseases such as psoriasis and morphea. Carboxytherapy has antioxidant effects, and leads to better tissue oxygenation, and release of growth factors. In this article, we decided to evaluate efficacy of combined carboxytherapy and narrowband-ultraviolet B (NB-UVB) compared to NB-UVB alone in the treatment of vitiligo. This is a prospective, split-body double-blind comparative study performed in patients with generalized stable vitiligo in acral areas and extremities referred to dermatology clinic of Afzalipour hospital in Kerman University of Medical Sciences. NB-UVB was performed three times a week in non-consecutive days for 4 months. In each patient, one lesion was randomly treated with carboxytherapy (weekly sessions for total of 16 sessions). Efficacy of treatment was evaluated by percentage of repigmentation of the lesions. Chi-square test and analysis of variance test (ANOVA) were used to compare efficacy of treatment based on demographic features of the patients and clinical features of the lesions, respectively. Twenty-eight patients with mean age of 32.35 ± 7.37 years old completed the study. At the end of the treatment, 37% of the patients in combination therapy group demonstrated more than 75% improvement compared to 0% in the monotherapy group (p = 0.001). There was no significant difference between either demographic features of the patients (age, sex, and skin phototypes) or duration of disease with efficacy of the treatment in both groups. Combination of carboxytherapy with NB-UVB leads to higher percentage of repigmentation and patients' satisfaction compared to monotherapy with NB-UVB.


Subject(s)
Ultraviolet Therapy , Vitiligo , Adult , Combined Modality Therapy , Humans , Prospective Studies , Skin/pathology , Treatment Outcome , Ultraviolet Therapy/adverse effects , Vitiligo/diagnosis , Vitiligo/drug therapy , Vitiligo/radiotherapy , Young Adult
3.
BMC Musculoskelet Disord ; 23(1): 308, 2022 Mar 31.
Article in English | MEDLINE | ID: mdl-35361169

ABSTRACT

BACKGROUND: Calcific tendinitis of the shoulder (CT) is a common disorder with a large disease burden. The initial treatment is with conservative measures. However, when this fails the next step treatment remains unclear. Minimal invasive treatment modalities have emerged. Needle aspiration of the calcific deposits (NACD) and extracorporeal shock wave therapy (ESWT) have both shown good clinical results. Nonetheless, in the current orthopedic literature there are not any studies available that compare both the effectiveness and cost-effectiveness of those two treatment modalities. Therefore, our primary objective is to compare the effectiveness of NACD to ESWT. A secondary objective is to compare the cost-effectiveness of both treatment modalities and workability. METHODS: Following a power calculation using the minimal clinical important difference of our primary outcome (Constant-Murley score, CMS) 140 patients will be included in the study. Enrolment is based upon strict inclusion/ exclusion criteria outlined in the Methods section. Participants will be randomized by computer in two groups (e.g. 70 patients will receive NACD and 70 patients will receive ESWT). The NACD treatment will consist of a sonographically guided removal of the calcific deposits and the ESWT treatment will be a focused ESWT. Both treatments will be conducted according to a standardized protocol, as part of care as usual in our hospital. The primary outcome will be the between group differences in functional outcome (measured with the CMS) between baseline and after 12 months follow-up. Secondary outcomes will be questionnaires regarding the clinical outcome (SST) and quality of life (EQ-5D-5L). Furthermore, NRS pain and cost related questionnaires (iPCQ and ProDisQ) will be collected during follow-up after two months, six months and at final follow-up after 12 months. DISCUSSION: This study will provide more insight regarding treatment for conservative therapy resistant calcific tendinitis of the shoulder by comparing NACD to focused ESWT, which will aid the physician and patient in determining the appropriate treatment plan. TRIAL REGISTRATION: Dutch trial register: NTR7093 registered on 11 March 2018.


Subject(s)
Calcinosis , Extracorporeal Shockwave Therapy , Tendinopathy , Calcinosis/complications , Calcinosis/diagnostic imaging , Calcinosis/therapy , Conservative Treatment , Humans , Quality of Life , Randomized Controlled Trials as Topic , Shoulder , Tendinopathy/complications , Tendinopathy/diagnostic imaging , Tendinopathy/therapy , Treatment Outcome
4.
BJOG ; 129(5): 805-811, 2022 Apr.
Article in English | MEDLINE | ID: mdl-34545675

ABSTRACT

OBJECTIVE: Pregnant women may develop disseminated intravascular coagulation (DIC), possibly resulting in massive maternal haemorrhage and perinatal death. The Japan guideline recommends use of antithrombin III (ATIII) for DIC in obstetrics; however, its effect remains uncertain. The present study aimed to investigate the effect of ATIII for DIC in obstetrics, using a national inpatient database in Japan. DESIGN: Nationwide observational study. SETTING: Japan. POPULATION: We used the Diagnosis Procedure Combination inpatient database to identify patients who delivered at hospital and were diagnosed with DIC from July 2010 to March 2018. METHODS: Propensity score matching analyses were performed to compare in-hospital maternal mortality and hysterectomy during hospitalisation between users and non-users of ATIII on the day of delivery. MAIN OUTCOME MEASURES: In-hospital mortality, hysterectomy. RESULTS: A total of 9920 patients were enrolled, including 4329 patients (44%) who used ATIII and 5511 patients (56%) who did not use ATIII. One-to-one propensity score matching created 3290 pairs. In-hospital maternal mortality did not differ significantly between the propensity-matched groups (0.3% in the ATIII group versus 0.5% in the control group; odds ratio 0.73; 95% CI 0.35-1.54). A significantly lower proportion of patients in the ATIII group, compared with those in the control group, underwent hysterectomy during hospitalisation (5.3% versus 8.7%; absolute risk difference -2.9%; 95% CI -4.2 to -1.6%). CONCLUSIONS: Although the present study did not show a mortality-reducing effect of ATIII for patients with DIC in obstetrics, it may have clinical benefit in terms of reducing the number of patients undergoing hysterectomy. TWEETABLE ABSTRACT: This study did not show mortality-reducing effect of antithrombin III for patients with DIC in obstetrics.


Subject(s)
Disseminated Intravascular Coagulation , Obstetrics , Antithrombin III/therapeutic use , Disseminated Intravascular Coagulation/diagnosis , Disseminated Intravascular Coagulation/drug therapy , Female , Humans , Japan/epidemiology , Pregnancy , Propensity Score , Treatment Outcome
5.
J Interv Cardiol ; 2022: 3932912, 2022.
Article in English | MEDLINE | ID: mdl-35360092

ABSTRACT

Background: The combined procedure of left atrial appendage closure (LAAC) and catheter ablation (CA) is a safe and feasible therapy to treat patients with atrial fibrillation (AF). However, the effect of the combined procedure on cardiac function remains unclear. This study aimed to investigate the changes in endocrine and mechanical function of the heart following the combined procedure. Methods: This retrospective study included 62 consecutive patients who underwent the combined procedure of AF ablation and WATCHMAN LAAC and 62 sex and age-matched patients who only received AF ablation. During follow-up, patients were examined for brain natriuretic peptide (BNP) levels to represent endocrine cardiac function. Mechanical cardiac function was assessed during echocardiographic examination by means of the LA ejection fraction, LA strain (Ƹ), and LA strain rate (SR). Results: (1) The BNP levels decreased acutely after the procedure, rose at day 3 postoperation, but trended downwards at 3 months postoperation in both groups. No significant difference was observed between the two groups. (2) LA ejection fraction, LA Ƹ, and SR exhibited a continuous upward trend over a 3-month follow-up in both groups. There was no significant difference in LA ejection fractions, SRe (the parameter of LA conduit function), and SRa (the parameter of LA booster pump function) between the two groups. However, the Ƹ and SRs (the parameters of LA reservoir function) improved in patients treated with CA alone. Conclusions: The combined procedure of LAAC and CA significantly improved the endocrine and mechanical function of the heart. Compared to simple CA, based on CA with LAAC intervention, it does not significantly change LA endocrine function but may lead to a decline in the LA reservoir function.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Catheter Ablation , Atrial Appendage/diagnostic imaging , Atrial Appendage/surgery , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Catheter Ablation/methods , Humans , Retrospective Studies , Treatment Outcome
6.
Säo Paulo med. j ; 140(3): 372-377, May-June 2022. tab, graf
Article in English | LILACS | ID: biblio-1377393

ABSTRACT

ABSTRACT BACKGROUND: Favipiravir is generally used in treating coronavirus disease 2019 (COVID-19) pneumonia in Turkey. OBJECTIVE: To determine the side effects of favipiravir and whether it is a good treatment option. DESIGN AND SETTING: Retrospective study conducted in Atatürk Chest Diseases and Chest Surgery Training and Research Hospital, Ankara, Turkey. METHODS: 357 patients who completed favipiravir treatment at the recommended dose were included. 37 patients with drug side effects and 320 patients without drug side effects were examined in two groups. RESULTS: Side effects were observed in 37 (10.36%) out of 357 patients using favipiravir. The most common side effect was liver dysfunction, in 26 (7.28%) of the patients. The following other side effects were also observed: diarrhea (1.4%), nausea (0.84%), abdominal pain (0.28%) and thrombocytopenia (0.28%). One patient (0.28%) presented both increased transaminases and nausea. CONCLUSION: In this study, it was determined that favipiravir may constitute an alternative for treating COVID-19 pneumonia given that its side effects are generally well tolerated and not serious.


Subject(s)
Drug-Related Side Effects and Adverse Reactions/drug therapy , COVID-19/drug therapy , Antiviral Agents/adverse effects , Pyrazines , Retrospective Studies , Treatment Outcome , Amides , SARS-CoV-2 , Nausea/chemically induced , Nausea/drug therapy
7.
Scand Cardiovasc J ; 56(1): 127-131, 2022 12.
Article in English | MEDLINE | ID: mdl-35652508

ABSTRACT

Objectives. To determine risk factors for radial artery and saphenous vein graft occlusion during long-term follow-up after coronary artery bypass grafting (CABG). Methods: From a cohort of 119 patients who had received a radial artery graft, 76 - of whom 55 also had at least one saphenous vein graft - underwent a preplanned direct angiography and anthropometric, biochemical, and endothelial function assessment 7.6-12.1 (mean 8.9) years after CABG. Comorbidity, medication, and smoking habits were also recorded. The association between these parameters and conduit longevity was analyzed in univariable and multivariable logistic regression models. Results: Radial artery graft occlusions were associated with higher plasma levels of high-sensitive C-reactive protein and patency was best among patients with pharmacologically treated hypertension. The sole independent risk factor identified for saphenous vein graft occlusion was tobacco smoking 8-12 years postoperatively. Conclusion: Our data support the contention that the pathogenesis of radial artery graft failure is distinct from vein graft disease and is related to hypertension status and systemic inflammation. These risk factors are potential targets for preventive measures. Accordingly, the study supports the eventual design of personalized secondary prevention regimens.Clinical registration number: ISRCTN23118170.


Subject(s)
Hypertension , Radial Artery , Coronary Angiography , Humans , Risk Factors , Saphenous Vein/transplantation , Treatment Outcome , Vascular Patency
9.
PLoS One ; 17(6): e0268690, 2022.
Article in English | MEDLINE | ID: mdl-35657973

ABSTRACT

BACKGROUND: Closure of a patent foramen ovale reduces the risk of recurrent stroke compared with medical therapy alone in young patients with cryptogenic strokes revealed by randomized control trials. Some cost-effectiveness analyses outside Japan have shown that patent foramen ovale closure is cost-effective, but no studies have examined cost-effectiveness in Japan. The objective of this study is to assess cost-effectiveness, from the perspective of a Japanese healthcare payer, of patent foramen ovale closure versus medical therapy alone for patients with patent foramen ovale related to cryptogenic strokes. METHODS: A cost-effectiveness study was conducted by developing a decision tree and a Markov model. Probabilities and a 5.9-year time horizon followed the RESPECT study. Utilities and costs were based upon published studies and assumptions. All assumptions were assessed by experts, including a cardiologist and a statistical expert. The target population comprised patients with cryptogenic stroke and patent foramen ovale, aged 60 years or younger. The model was discounted at 2.0% and its cycle was one month. A willingness-to-pay threshold is set at $50,000 / quality-adjusted life years (QALYs). Incremental cost-effectiveness ratio was evaluated. Then one-way sensitivity analyses as deterministic sensitivity analysis, and probabilistic sensitivity analyses were performed to assess data robustness. RESULTS: Incremental quality-adjusted life years, incremental costs, and incremental cost-effectiveness ratio were 0.464, $13,562, and $29,208 per QALY gained, respectively. One-way sensitivity analysis showed that the stable state utility score difference between patent foramen ovale closure and medical therapy had the largest impact on incremental cost-effectiveness ratio. Patent foramen ovale closure is cost-effective at a stable state utility score difference of >0.051, compared with medical therapy. Probabilistic sensitivity analyses demonstrated that patent foramen ovale closure was 50.3% cost-effective. CONCLUSIONS: Patent foramen ovale closure was cost-effective compared with medical therapy for Japanese patients with cryptogenic stroke who were ≤60 years.


Subject(s)
Foramen Ovale, Patent , Ischemic Stroke , Stroke , Adult , Cost-Benefit Analysis , Foramen Ovale, Patent/complications , Foramen Ovale, Patent/therapy , Humans , Middle Aged , Secondary Prevention/methods , Stroke/etiology , Stroke/therapy , Treatment Outcome
11.
Pak J Pharm Sci ; 35(2(Special)): 657-663, 2022 Mar.
Article in English | MEDLINE | ID: mdl-35668567

ABSTRACT

To analyze the clinical efficacy and safety of norepinephrine combined with ulinastatin in the treatment of septic shock. 100 patients with septic shock treated in our institution from May 2019 to May 2021 were recruited and randomly assigned to receive either norepinephrine (control group) or norepinephrine plus ulinastatin (experimental group) according to the treatment scheme. The treatment efficacy, time for shock improvement, intensive care unit (ICU) stay, total hospital stay, in-hospital mortality, 30-day survival, and changes in inflammatory factors (plasma C-reactive protein (CRP), serum lactic acid (LAC), serum procalcitonin (PCT), and interleukin-10 (IL-10)) before and after treatment were analyzed, and the sequential organ failure scores of the two groups were compared. The experimental group exhibited superior performance with respect to efficacy, ICU stays, and total hospital stay, in-hospital mortality to the control group (all P<0.05). After treatment, the experimental group presented lower levels of CRP, LAC, PCT and IL-10 and higher SOFA scores than the control group (P<0.05). Norepinephrine plus ulinastatin achieved remarkable results in the treatment of septic shock, improving the treatment efficiency, shortening the time for shock improvement and hospitalization, reducing hospital mortality, driving down the expression of inflammatory factors and enhancing the survival of patients, with high safety.


Subject(s)
Sepsis , Shock, Septic , Glycoproteins , Humans , Interleukin-10 , Norepinephrine/adverse effects , Procalcitonin , Prognosis , Retrospective Studies , Shock, Septic/drug therapy , Treatment Outcome
12.
Int J Med Inform ; 164: 104806, 2022 Aug.
Article in English | MEDLINE | ID: mdl-35671586

ABSTRACT

BACKGROUND: The Dutch Surgical Aneurysm Audit (DSAA) is a nationwide mandatory quality registry that evaluates the perioperative outcomes of abdominal aortic aneurysms (AAAs). The DSAA includes perioperative outcomes that occur up to 30 days, but various complications following AAA repair occur after this period. Administrative healthcare data yield the possibility to evaluate later occuring outcomes such as reinterventions, without increasing the registration burden. The aim of this study is to assess the feasibility and the potential benefit of administrative healthcare data to evaluate mid-term reinterventions following intact AAA repair. METHOD: All patients that underwent primary endovascular aneurysm repair (EVAR) or open surgical repair (OSR) for an intact infrarenal AAA between January 2017 and December 2018 were selected from the DSAA. Subsequently, these patients were identified in a database containing reimbursement data. Healthcare activity codes that refer to reinterventions following AAA repair were examined to assess reinterventions within 12 and 15 months following EVAR and OSR. RESULTS: We selected 4043 patients from the DSAA, and 2059 (51%) patients could be identified in the administrative healthcare database. Reintervention rates of 10.4% following EVAR and 9.5% following OSR within 12 months (p = 0.719), and 11.5% following EVAR and 10.8% following OSR within 15 months (p = 0.785) were reported. CONCLUSION: Administrative healthcare data as an addition to the DSAA is potentially beneficial to evaluate mid-term reinterventions following intact AAA repair without increasing the registration burden for clinicians. Further validation is necessary before reliable implementation of this tool is warranted.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aortic Aneurysm, Abdominal/surgery , Delivery of Health Care , Humans , Pilot Projects , Postoperative Complications/epidemiology , Postoperative Complications/surgery , Retrospective Studies , Risk Factors , Treatment Outcome
13.
Sci Rep ; 12(1): 9448, 2022 Jun 08.
Article in English | MEDLINE | ID: mdl-35676323

ABSTRACT

This study aimed to explore the feasibility of Phase I percutaneous spinal endoscopy with a 270° single incision in the ventral and dorsal dura mater for decompression treatment of thoracic spinal stenosis (TSS). Phase I percutaneous spinal endoscopy with a two-path (posterior and posterolateral approaches) single incision with a 270° decompression was performed in four cases of TSS with compression in the ventral and dorsal dura mater. The affected intervertebral space was located during the surgery, and the ossified ligamentum flavum in the ventral and dorsal dura mater was removed via laminectomy, which formed a decompression space in the thoracic cord. Next, posterolateral transforaminal expansion and plasty were performed to remove the ventral intervertebral disk. The visual analogue scale (VAS) score, thoracic spinal cord function score of the Japanese Orthopaedic Association (JOA) (11-point method), and Oswestry Disability Index (ODI) scores were used to evaluate the clinical efficacy. No dura mater or thoracic nerve injury occurred during the surgery. The symptoms of weakness in the lower extremities improved after the surgery. The postoperative magnetic resonance imaging and computed tomography examinations showed compression removal and dura mater bulging. The postoperative VAS, JOA, and ODI scores improved compared with the preoperative scores. Two surgical trajectories, posterior and posterolateral approaches, were established by a single incision using thoracic spinal canal decompression with Phase I 270° single-incision percutaneous spinal endoscopy. The posterior approach was performed mainly by translaminar unilateral fenestration and bilateral decompression in the ventral and dorsal dura mater, whereas the posterolateral approach was performed by decompression in the ventral dura mater to the midline of the vertebrae. This surgical method could be applied as a safe and feasible minimally invasive treatment for TSS with compression on both the ventral and dorsal dura mater.


Subject(s)
Spinal Stenosis , Thoracic Diseases , Decompression, Surgical/methods , Endoscopy/methods , Endoscopy, Gastrointestinal , Feasibility Studies , Humans , Lumbar Vertebrae/surgery , Retrospective Studies , Spinal Canal , Spinal Stenosis/diagnostic imaging , Spinal Stenosis/surgery , Treatment Outcome
14.
Biomed Pharmacother ; 151: 113189, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35676789

ABSTRACT

Tuberculosis (TB) and human immunodeficiency virus (HIV) represent a significant burden of disease on a global scale. Despite improvements in the global epidemic status, largely facilitated by increased access to pharmacotherapeutic interventions, slow progress in the development of new clinical interventions coupled with growing antimicrobial resistance to existing therapies represents a global health crisis. There is an urgent need to expand the armamentarium of TB and HIV therapeutic strategies. Host mediated immune responses represent an untapped reservoir of novel approaches for TB and HIV. Antimicrobial peptides (AMPs) are an essential aspect of the immune system. Cathelicidins and defensins AMPs have been studied for their potential applications in TB and HIV therapeutic interventions. Genetic polymorphism across different population groups may affect endogenous expression or activity of AMPs, potentially influencing therapeutic outcomes. However, certain genetic polymorphisms in autophagy pathways may alter the downstream effects of nano-delivery of cathelicidin. On the other hand, certain genetic polymorphisms in beta-defensins may provide a protective role in reducing HIV-1 mother-to-child-transmission. Pharmaceutical development of cathelicidins and defensins is disadvantaged with complex challenges. Nanoparticle formulations improve pharmacokinetics and biocompatibility while facilitating targeted drug delivery, potentially minimising the risk of immunogenicity or non-specific haemolytic activity. This review aims to explore the potential viability of using cathelicidins and defensins as novel pharmacotherapy in the management of TB and HIV, highlight potential pharmacogenomic implications in host mediated immunity and AMP therapeutic applications, as well as propose novel drug delivery strategies represented by nanomedicine for AMPs.


Subject(s)
Cathelicidins , Defensins , HIV Infections , Nanomedicine , Pharmacogenetics , Tuberculosis , Antimicrobial Cationic Peptides , Cathelicidins/genetics , Defensins/genetics , HIV Infections/drug therapy , HIV Infections/genetics , Humans , Infectious Disease Transmission, Vertical , Treatment Outcome , Tuberculosis/drug therapy , Tuberculosis/genetics
15.
JACC Cardiovasc Interv ; 15(11): 1126-1136, 2022 Jun 13.
Article in English | MEDLINE | ID: mdl-35680192

ABSTRACT

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is generally performed without control over the alignment of the bioprosthesis to the native aortic valve (AV) commissures. Data on the impact of commissural misalignment (CMA) on the clinical and hemodynamic outcome after TAVR are scarce. OBJECTIVES: The aim of this study was to investigate the impact of commissural misalignment (CMA) on the clinical and hemodynamic outcome in patients with severe tricuspid aortic stenosis undergoing TAVR using the balloon-expandable (BE) SAPIEN 3 valve (Edwards LifeSciences). METHODS: Clinical data of consecutive patients who underwent BE TAVR at Cedars-Sinai Medical Center (Los Angeles, California, USA) enrolled in the RESOLVE (Assessment of TRanscathetER and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation) registry were retrospectively analyzed to evaluate CMA, which was defined as a neocommissure position >30° compared with native commissures on computed tomography. RESULTS: A total of 324 patients (36.6% female, median Society of Thoracic Surgeons score of 3.9%) were included in the analysis. CMA was present in 171 individuals (52.8%). At 30 days, rates of aortic regurgitation greater than mild (5.6%) and a residual AV gradient ≥20 mm Hg (7.4%) were not different between CMA and non-CMA patients. Commissural orientation was independently associated with a relative AV mean gradient increase >50% from discharge to 30 days (per increase of 10° misalignment; OR: 1.3; 95% CI: 1.0-1.4; P = 0.01). The long-term composite outcome of death or stroke was not different between groups (log-rank P = 0.29). CONCLUSIONS: In patients with severe tricuspid aortic stenosis who undergo SAPIEN 3 TAVR, the neocommissures align randomly. Our data demonstrate that commissural alignment may impact device performance and clinical outcomes in patients undergoing BE TAVR. (Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic VaLVve Dysfunction with Multimodality Imaging and Its TrEatment with Anticoagulation [RESOLVE]; NCT02318342).


Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Anticoagulants , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Female , Hemodynamics , Humans , Male , Retrospective Studies , Risk Factors , Thrombosis , Treatment Outcome
16.
JACC Cardiovasc Interv ; 15(11): 1167-1175, 2022 Jun 13.
Article in English | MEDLINE | ID: mdl-35680197

ABSTRACT

BACKGROUND: The author recently reported ∼50% excess early mortality in patients with first-presentation ST-segment elevation myocardial infarction (STEMI) without standard modifiable cardiovascular risk factors (SMuRFs); the cause of this is not clear. OBJECTIVES: The aim of this study was to examine differences in infarct characteristics and clinical outcomes in patients with versus without SMuRFs (dyslipidemia, hypertension, diabetes mellitus, and smoking). METHODS: Individual-level data were pooled from 10 randomized percutaneous intervention (PCI) trials in which infarct size was measured within 1 month by either cardiac magnetic resonance or technetium-99m sestamibi single-photon emission computed tomography imaging. First-presentation STEMI was classified into 2 groups according to the presence or absence of at least 1 SMuRF. RESULTS: Among 2,862 patients, 524 (18.3%) were SMuRF-less. After adjusting for study effect, SMuRF-less patients had more frequent poor pre-PCI flow Thrombolysis In Myocardial Infarction 0/1 compared with patients with at least 1 SMuRF (72.0% vs 64.1%; OR: 1.35; 95% CI: 1.08-1.70). There were no independent associations between the presence or absence of SMuRFs at baseline and infarct size (estimate = -0.35; 95% CI: -1.93 to 1.23), left ventricular ejection fraction (estimate = -0.06; 95% CI: -1.33 to 1.20), or mortality at 30 days (HR: 0.46; 95% CI: 0.19-1.07) and 1 year (HR: 0.74; 95% CI: 0.43-1.29). CONCLUSIONS: First-presentation STEMI patients with no identifiable baseline SMuRFs had a higher risk of Thrombolysis In Myocardial Infarction flow grade 0/1 pre-PCI. However, after adjustment, there were no significant associations between SMuRF-less status and infarct size, left ventricle ejection fraction, or mortality.


Subject(s)
Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Cardiovascular Diseases , Heart Disease Risk Factors , Humans , Myocardial Infarction/etiology , Percutaneous Coronary Intervention/adverse effects , Randomized Controlled Trials as Topic , Risk Factors , ST Elevation Myocardial Infarction/diagnostic imaging , ST Elevation Myocardial Infarction/therapy , Stroke Volume , Treatment Outcome , Ventricular Function, Left
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