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1.
Artigo em Inglês | MEDLINE | ID: mdl-39206538

RESUMO

BACKGROUND: Calcification within chronic total occlusions (CTO) is strongly associated with worse outcomes. Despite the excellent success and safety of intravascular lithotripsy (IVL) in heavily calcified lesions, evidence in CTO remains scarce. AIM: This study aimed to evaluate the procedural and long-term clinical outcomes of IVL in heavily calcified CTO. METHODS: Patients who underwent IVL between 2019 and 2024 from an ongoing prospective multicenter registry were eligible for inclusion. Patients were therefore classified in CTO and non-CTO groups. The efficacy and safety endpoints of CTO percutaneous coronary interventions were defined according to the CTO-ARC consensus. In-hospital major adverse cardiovascular events (MACE) included cardiac death, nonfatal myocardial infarction and target lesion revascularization (TVR). RESULTS: A total of 404 patients underwent IVL, of which the treated lesion was a CTO in 33 (8.2%). The mean J-CTO score was 2.3 ± 1.1. Device success showed no significant difference between CTO and non-CTO groups (100% vs 98.4%; p = 0.35). Comparable technical success with residual stenosis <30% was observed in both groups (90.1% in CTO vs 89.2% in non-CTO, p = 0.83). The incidence of MACE was similar across groups during hospital stays (CTO 6.0% vs. non-CTO 1.9%, p = 0.12), at 30-day (CTO 9.1% vs. non-CTO 3.0%, p = 0.07), and at 12-month follow-up (CTO 9.1% vs. non-CTO 7.3%, p = 0.70). CONCLUSION: IVL provides high procedural success and consistent clinical outcomes in both CTO and non-CTO cases, reinforcing its role in managing heavily calcified coronary lesions.

2.
Skin Res Technol ; 30(4): e13682, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38616504

RESUMO

BACKGROUND: Natural products are often friendly and can be used on children's skin after systematic and careful research. Therefore, in this study, the Royal Oji Complex (ROC), a product with natural ingredients, was used to study their effectiveness on keratinocytes taken from the skin of children from 0 to 3 years old. METHOD: Normal human epidermal keratinocytes and tissue-isolated keratinocytes (TIKC) from young donors were treated with three different concentrations of ROC: 0.1, 1, and 10 ppm. The mRNA expression of the epidermal barrier's essential genes, such as hyaluronic acid synthase 3 (Has3), involucrin (IVL), loricrin (LOR), and claudin-1 (CLD1) was investigated using qRT-PCR. Ceramide content was measured by ELISA, with retinoic acid (R.A.) and amarogentin (AMA) serving as positive controls. RESULTS: ROC significantly elevated HAS3 gene expression in HEKn cells, especially at 10 ppm, indicating potential advantages for skin hydration in young infants. IVL increased at first but decreased as ROC concentrations increased. LOR was upregulated at lower ROC concentrations but reduced at higher doses. CLD1 gene expression increased considerably in HEKn but reduced with increasing ROC doses. Ceramide concentration increased somewhat but not significantly at 10 ppm. CONCLUSION: ROC shows potential in altering keratinocyte gene expression, with unique responses in HEKn and TIKC from young donors. While changes in ceramide content were insignificant, these results help to comprehend ROC's multiple effects on young children's skin.


Assuntos
Queratinócitos , Pele , Criança , Lactente , Humanos , Pré-Escolar , Recém-Nascido , Epiderme , Ceramidas , Doadores de Tecidos
3.
Vascular ; : 17085381241257736, 2024 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-38807487

RESUMO

PURPOSE: To report the first chronic limb-threatening ischemia (CLTI) patients who underwent an intravascular lithotripsy (IVL)-assisted percutaneous deep vein arterialization (pDVA). CASE REPORT 1: An 81-year-old patient presented with CLTI and a heavily calcified lesion of the popliteal artery and tibioperoneal trunk (TPT), with a distal tibial and foot arch occlusion. The patient underwent IVL and drug-coated balloon angioplasty for the distal popliteal artery and of the TPT to improve the inflow prior to pDVA. The wound situation remained stable without secondary procedure until the patient`s deaths due to complications of urosepsis 3 months later. CASE REPORT 2: A 64-year-old patient with rest pain of the left limb with a single-vessel tibial run-off (peroneal artery) and occluded pedal arch was treated with 3.5 mm IVL followed by a successful pDVA as mentioned above. IVL performed in the proximal posterior tibial artery to optimize the inflow to the circuit and change the compliance of the crossing point from the arterial to the vein system. The patient underwent repeat angioplasty of the plantar vein arch 5 months after the index procedure and thereafter remained asymptomatic during 2 years of follow-up. CONCLUSION: The combined use of IVL and pDVA could improve the patency of the reconstruction with clinical benefits in no-option CTLI patients.

4.
Arch Gynecol Obstet ; 309(2): 621-629, 2024 02.
Artigo em Inglês | MEDLINE | ID: mdl-38085353

RESUMO

OBJECTIVE: This study provides a concise overview of diagnostic and treatment strategies for intravenous leiomyomatosis (IVL), a rare disease with nonspecific clinical manifestations, based on cases from a tertiary referral hospital in China. METHODS: We retrospectively analyzed 11 premenopausal patients with confirmed IVL between 2018 and 2022. Clinical data from Ultrasound, Enhanced CT, and MRI were studied, along with surgical details, postoperative pathology, and follow-up information. RESULTS: Premenopausal patients showed no disease-specific symptoms, with 90.9% having a history of gynecological or obstetric surgery, and 72.7% having prior uterine fibroids. Cardiac involvement was evident in two cases, with echocardiography detecting abnormal floating masses from the inferior vena cava. Pelvic ultrasound indicated leiomyoma in 90.9% of cases, with ≥ 50 mm size. Surgery was the primary treatment, and lesions above the internal iliac vein resulted in significantly higher intraoperative blood loss (median 1300 ml vs. 50 ml, p = 0.005) and longer hospital stays (median 10 days vs. 4 days, p = 0.026). Three patients with lesions above the inferior vena cava required combined surgery with cardiac specialists. Recurrence occurred in 2 out of 11 patients with incomplete lesion resection. CONCLUSIONS: IVL mainly affects premenopausal women with uterine masses, primarily in the pelvic cavity (Stage I). Pelvic ultrasound aids early screening, while Enhanced CT or MR assists in diagnosing and assessing venous lesions. Complete resection is crucial to prevent recurrence. Lesions invading the internal iliac vein and above pose higher risks during surgery. A multidisciplinary team approach is essential for patients with lesions above the inferior vena cava, with simultaneous surgery as a potential treatment option.


Assuntos
Neoplasias Cardíacas , Leiomiomatose , Neoplasias Uterinas , Neoplasias Vasculares , Humanos , Feminino , Estudos Retrospectivos , Leiomiomatose/diagnóstico por imagem , Leiomiomatose/cirurgia , Leiomiomatose/patologia , Neoplasias Cardíacas/diagnóstico por imagem , Neoplasias Cardíacas/cirurgia , Neoplasias Cardíacas/patologia , Veia Cava Inferior/diagnóstico por imagem , Veia Cava Inferior/cirurgia , Veia Cava Inferior/patologia , Ultrassonografia , Neoplasias Uterinas/diagnóstico por imagem , Neoplasias Uterinas/cirurgia , Neoplasias Uterinas/patologia , Neoplasias Vasculares/diagnóstico por imagem , Neoplasias Vasculares/cirurgia , Neoplasias Vasculares/patologia
5.
Vasa ; 53(4): 263-274, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38934125

RESUMO

Background: Heavily calcified peripheral artery lesions increase the risk of vascular complications, constituting a severe challenge for the operator during catheter-based cardiovascular interventions. Intravascular Lithotripsy (IVL) technology disrupts subendothelial calcification by using localized pulsative sonic pressure waves and represents a promising technique for plaque modification in patients with severe calcification in peripheral arteries. Purpose: Our aim was to systematically review and summarize available data regarding the safety and efficacy of IVL in preparing severely calcified peripheral arteries and its use in Transcatheter Aortic Valve Implantation (TAVI). Patients and methods: This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL in the peripheral vasculature. The diameter of the vessel lumen before and after IVL was estimated. The occurrence of peri-procedural complications was assessed using a random-effects model. Results: 20 studies with a total of 1,223 patients with heavily calcified peripheral lesions were analysed. The mean age of the cohort was 70.6 ± 17.4 years. Successful IVL delivery achieved in 100% (95% CI: 100%-100%, I2 = 0%), with an increase in the luminal diameter (SMD: 4.66, 95% CI: 3.41-5.92, I2 = 90.8%) and reduction in diameter stenosis (SMD: -4.15, 95% CI: -4.75 to -3.55, I2 = 92.8%), and a concomitant low rate of complications. The procedure was free from dissection in 97% (95% CI: 91%-100%, I2 = 81.4%) while dissections of any type (A, B, C, or D) were observed in 6% (95% CI: 2%-10%, I2 = 85.3%) of the patients. Several rare cases of abrupt closure, no-reflow phenomenon, perforation, thrombus formation, and distal embolization were recorded. Finally, the subgroup analysis of patients who underwent a TAVI with IVL assistance presented successful implantation in 100% (95% CI: 100%-100%, I2 = 0%) of the cases, with only 4% (95% CI: 0%-12%, I2 = 68.96%) presenting dissections of any sort. Conclusions: IVL seems to be an effective and safe technique for modifying severely calcified lesions in peripheral arteries and it is a promising modality in TAVI settings. Future prospective studies are needed to validate our results.


Assuntos
Litotripsia , Doença Arterial Periférica , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter , Calcificação Vascular , Humanos , Litotripsia/efeitos adversos , Calcificação Vascular/terapia , Calcificação Vascular/diagnóstico por imagem , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento , Doença Arterial Periférica/terapia , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Masculino , Idoso , Idoso de 80 Anos ou mais , Feminino , Fatores de Risco , Pessoa de Meia-Idade , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/fisiopatologia
6.
J Endovasc Ther ; 30(1): 106-113, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-35130782

RESUMO

INTRODUCTION: The combination of intravascular lithotripsy (IVL) and drug-coated balloon (DCB) angioplasty for calcified peripheral lesions is associated with promising short-term results. However, data regarding the 12 months performance of this treatment option is missing. This study reports on the outcomes of IVL and DCB angioplasty for calcified femoropopliteal disease. METHODS: Patients treated with IVL and DCB for calcified femoropopliteal lesions between February 2017 and September 2020 were included into this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization (TLR) and overall mortality were additionally analyzed. RESULTS: Fifty-five (n = 55) patients and 71 lesions were analyzed. Most patients presented with long-term limb-threatening ischemia (n = 31, 56%), 47% (n = 26) were diabetics, and 66% (n = 36) had long-term kidney disease. The median lesion length was 77 mm (interquartile range: 45-136), and 20% (n = 14) of the lesions were chronic total occlusions (CTOs). Eccentric calcification was found in 23% of the vessels (n = 16), and circumferential calcium (peripheral arterial calcium scoring system [PACSS] Class 3 and 4) was present in 78% (n = 55) of the treated lesions.The technical success after IVL amounted to 87% (n = 62) and the procedural success to 97% (n = 69). A flow-limiting dissection was observed in 2 cases (3%). Both the rates of target lesion perforation and distal embolization were 1% (n = 1). A bail-out scaffold was deployed in 5 lesions (7%). At 12 months the Kaplan-Meier estimate of primary patency was 81%, the freedom from TLR was 92% and the secondary patency 98%. The overall survival amounted to 89%, while the freedom from major amputation to 98%. The presence of eccentric disease, CTOs, or PACSS Class 4 did not increase the risk for loss of patency or TLR. CONCLUSIONS: In this challenging cohort of patients, the use of IVL and DCB for calcified femoropopliteal lesions was associated with promising 12 months outcomes and an excellent safety profile.


Assuntos
Angioplastia com Balão , Doença Arterial Periférica , Humanos , Artéria Poplítea/diagnóstico por imagem , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Cálcio , Resultado do Tratamento , Fatores de Tempo , Artéria Femoral/diagnóstico por imagem , Angioplastia com Balão/efeitos adversos , Isquemia/diagnóstico por imagem , Isquemia/terapia , Grau de Desobstrução Vascular , Materiais Revestidos Biocompatíveis , Paclitaxel/efeitos adversos
7.
J Endovasc Ther ; : 15266028231205421, 2023 Oct 18.
Artigo em Inglês | MEDLINE | ID: mdl-37853746

RESUMO

PURPOSE: Vessel calcification is estimated to be present in 30% to 50% of patients with peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is unique compared with other arteries due to its exposure to significant deformation and biomechanical stress during knee motion. Intravascular lithotripsy (IVL) is a novel technique that uses acoustic pressure waves to cause microfractures within the intimal and medial wall calcification. Intravascular lithotripsy is safe in femoropopliteal and infrapopliteal lesions, but follow-up studies are lacking. Therefore, the purpose of this study was to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease. METHODS: This prospective, multicenter cohort study included all patients treated with IVL in the popliteal and infrapopliteal arteries at 4 sites. Standardized follow-up with duplex ultrasonography was scheduled at 6 to 8 weeks and 12 months. The primary safety endpoint was a composite of major adverse events (MAEs) at 30 days. Primary efficacy endpoints were primary patency, limb salvage, and amputation-free survival (AFS) at 12 months. Secondary endpoints were primary-assisted patency and freedom from target lesion revascularization (TLR). Endpoints were distributed for patients with chronic limb-threatening ischemia (CLTI) and intermittent claudication (IC) and estimated using the Kaplan-Meier method. RESULTS: Between April 2021 and March 2023, 29 patients with 30 limbs were treated. Diabetes mellitus (DM) and CLTI were present in 62.1% and 80.0% of patients, respectively. Within the 32 treated lesions, severe calcification was present in 84.4% and bailout stenting was necessary in 12.5% of the lesions. Four MAEs occurred within 30 days: 1 closure device failure, 1 major amputation, and 2 deaths, neither of which was related to the study device. The primary patency, primary-assisted patency, freedom from TLR, limb salvage, and AFS at 12 months were 68.8%, 90.0%, 93.3%, 83.9%, and 57.1% for CLTI patients, respectively. No events occurred in restenosis, re-occlusion, TLR, major amputation, or mortality in patients with IC. CONCLUSIONS: This first-ever analysis on follow-up outcomes of IVL in the popliteal and infrapopliteal arteries demonstrated promising safety and efficacy outcomes with a low rate of bailout stenting. CLINICAL IMPACT: Vessel calcification is a common feature in peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is subjected to biomechanical stress during knee motion, which makes stenting unappealing and often leads to worse clinical outcomes. This study aimed to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease. As in line with previous studies, no relevant procedural complications were found and the rate of bail-out stenting was only 12.5%. Moreover, in a complex patient population, this study demonstrated promising safety and efficacy outcomes. The comparison of IVL with angioplasty alone or other vessel preparation devices for popliteal and infrapopliteal arterial disease is warranted.

8.
Rinsho Ketsueki ; 63(3): 182-188, 2022.
Artigo em Japonês | MEDLINE | ID: mdl-35387930

RESUMO

Intravascular large B-cell lymphoma (IVLBCL) is a rare form of non-Hodgkin B-cell lymphoma which occurs mainly in capillaries and small blood vessels. Successful diagnosis of IVLBCL is challenging since it lacks tumor formation and presents various clinical manifestations. An 82-year-old Asian female patient presented to our emergency department with a history of general fatigue, weight loss, and fever for two weeks. The patient's random skin biopsy was negative, and her bone marrow biopsy revealed hemophagocytic syndrome with no obvious involvement of lymphoma cells. Gallium scintigraphy showed mild uptake in the uterus, pelvis, and spine. The repetitive bone marrow biopsy result and the endometrial cytology/biopsy were negative; however, the pelvic MRI was compatible with lymphoma, revealing lesions in the corpus uteri, pelvis, and vertebral body. After laparoscopic-assisted vaginal total hysterectomy and bilateral salpingo-oophorectomy, the diagnosis of the Asian variant of IVLBCL was made. Although total hysterectomy remains controversial for elderly patients with declining performance status, we could successfully diagnose the condition and initiate the treatment. The patient's general condition improved soon after starting rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone regimen on day 26, and she was discharged on day 45.


Assuntos
Linfoma Difuso de Grandes Células B , Neoplasias Vasculares , Idoso de 80 Anos ou mais , Anticorpos Monoclonais Murinos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Biópsia , Feminino , Humanos , Histerectomia , Linfoma Difuso de Grandes Células B/tratamento farmacológico , Rituximab/uso terapêutico , Neoplasias Vasculares/diagnóstico , Vincristina/uso terapêutico
9.
Aesthetic Plast Surg ; 45(4): 1792-1801, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33876290

RESUMO

BACKGROUND: Poly-L-lactic acid (PLLA) is widely used in tissue engineering. The natural polymer hyaluronic acid (HA) shows excellent biocompatibility and affects cell signaling, proliferation, and differentiation. In addition, a polynucleotide (PN) induces cell growth of human skin fibroblasts and osteoblasts. OBJECTIVE: In this study, we evaluated the properties, safety, and efficacy of a novel composite filler consisting of cross-linked HA with PN in combination with monodisperse PLLA microspheres manufactured using Inventage Lab Precision Particle Fabrication method. MATERIALS AND METHODS: The composition of the filler and characteristics of the microspheres were examined via scanning electron microscopy, particle size analysis, gel permeation chromatography, and rheology and osmolality measurement. Additionally, safety and efficacy of HA-PN/PLLA composite filler were conducted in in vitro and in vivo. RESULTS: Analysis of PLLA microspheres revealed spherical surfaces and a narrower particle size distribution than that in PLLA filler. HA-PN/PLLA composite filler had higher viscosity and elasticity values and similar osmolality as compared to those of HA and PN fillers. The nontoxicity in in vitro and in vivo tests reflected that the composite filler may be safe for human use. In addition, the composite filler maintained a more stable volume than did HA filler for 24 weeks after administration in HWY/Slc hairless rats. Furthermore, the results support the effect of HA-PN/PLLA in restoring skin structure. CONCLUSION: Altogether, these data suggest that the novel composite filler might be a safe and effective option in terms of tissue integration, clinical management during delivery and high esthetic durability. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .


Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos , Ácido Hialurônico , Poliésteres , Polinucleotídeos
10.
Microbiol Immunol ; 63(5): 186-193, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31009089

RESUMO

The cell wall-anchored protein-encoding spj gene on staphylococcal cassette chromosome mec IVl (SCCmecIVl) was found to vary in size because of its 22- and 86-aa repeat domains. The 22-aa repeats are the more flexible of the two repeats, comprising three 11-aa units, and were classified into three groups with eleven types. The 11/22-aa repeats are longer in individuals with bullous impetigo, shorter in those with invasive disease and were absent in a fatal case, this last one having been rapidly diagnosed by PCR. IS431-flanking pUB110 (bleO, aadD) is present on SCCmecIVl at 90%. The bacterial surface has the spj product and a unique surface layer.


Assuntos
Proteínas de Bactérias/genética , Parede Celular/microbiologia , Infecções Comunitárias Adquiridas/microbiologia , Staphylococcus aureus Resistente à Meticilina/genética , Staphylococcus aureus Resistente à Meticilina/patogenicidade , Infecções Estafilocócicas/microbiologia , Humanos , Virulência
11.
Int J Mol Sci ; 18(7)2017 Jun 27.
Artigo em Inglês | MEDLINE | ID: mdl-28654000

RESUMO

Non-melanomatous skin cancers (NMSCs), which include basal and squamous cell carcinoma (BCC and SCC respectively), represent a significant burden on the population, as well as an economic load to the health care system; yet treatments of these preventable cancers remain ineffective. Studies estimate that there has been a 2-fold increase in the incidence of NMSCs between the 1960s and 1980s. The increase in cases of NMSCs, as well as the lack of effective treatments, makes the need for novel therapeutic approaches all the more necessary. To rationally develop more targeted treatments for NMSCs, a better understanding of the cell of origin, in addition to the underlying pathophysiological mechanisms that govern the development of these cancers, is urgently required. Research over the past few years has provided data supporting both a "bottom up" and "top down" mechanism of tumourigenesis. The "bottom up" concept involves a cancer stem cell originating in the basal compartment of the skin, which ordinarily houses the progenitor cells that contribute towards wound healing and normal cell turnover of overlying epidermal skin layers. The "top down" concept involves a more differentiated cell undergoing genetic modifications leading to dedifferentiation, giving rise to cancer initiating cells (CICs). This review explores both concepts, to paint a picture of the skin SCC cell of origin, the underlying biology, and also how this knowledge might be exploited to develop novel therapies.


Assuntos
Carcinoma Basocelular/patologia , Carcinoma de Células Escamosas/patologia , Epiderme/patologia , Células-Tronco Neoplásicas/patologia , Neoplasias Cutâneas/patologia , Pele/patologia , Animais , Carcinogênese/genética , Carcinogênese/patologia , Carcinoma Basocelular/genética , Carcinoma de Células Escamosas/genética , Desdiferenciação Celular , Proteínas de Ligação a DNA/análise , Proteínas de Ligação a DNA/genética , Epiderme/metabolismo , Regulação Neoplásica da Expressão Gênica , Humanos , Células-Tronco Neoplásicas/metabolismo , Pele/metabolismo , Neoplasias Cutâneas/genética , Fatores de Transcrição/análise , Fatores de Transcrição/genética
13.
J Minim Invasive Gynecol ; 23(6): 849-50, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26802907

RESUMO

Laparoscopic imaging of intravenous leiomyomatosis is rare. We report a 35-year-old woman with uterine leiomyomatosis, laparoscopic hysterectomy exposed parametrial vessels with whitish plugs extending intravascularly toward the pelvic sidewall. Complete surgical resection and long-term follow-up are important.


Assuntos
Vasos Sanguíneos/patologia , Leiomiomatose/patologia , Pelve/irrigação sanguínea , Neoplasias Vasculares/patologia , Adulto , Feminino , Humanos , Histerectomia , Leiomiomatose/cirurgia , Neoplasias Uterinas/patologia , Neoplasias Uterinas/cirurgia , Neoplasias Vasculares/cirurgia
14.
J Clin Med ; 13(5)2024 Mar 04.
Artigo em Inglês | MEDLINE | ID: mdl-38592323

RESUMO

(1) Background: Transfemoral transcatheter aortic valve implantation (TAVI) has become the standard treatment for most patients with severe symptomatic aortic stenosis. Intravascular lithotripsy may facilitate transfemoral TAVI (IVL-TAVI) even in patients with severely calcified iliofemoral disease. We assessed technical aspects and clinical outcomes of this novel approach compared to alternative transaxillary access (TAX-TAVI). (2) Methods: IVL-TAVI was performed for severe iliofemoral calcifications precluding standard transfemoral access in 30 patients from 2019 to 2022 at a single academic heart center. IVL was performed as part of the TAVI procedure in all cases. Results were compared to a control group of 44 TAX-TAVI procedures performed for the same indication from 2016 to 2021. The safety outcome was a composite of all-cause death, stroke, access-related bleeding ≥ type 2 within 24 h and major vascular access site complications at 30 days. The efficacy outcome was defined as a technical success according to VARC-3. (3) Results: Median age was 78.2 [74.3, 82.6] years, 45.9% were female and mean STS-PROM was 3.6% [2.3, 6.0]. Iliofemoral calcifications were more severe in the IVL-TAVI vs. TAX-TAVI groups (lesion length: 63.0 mm [48.6, 80.3] vs. 48.5 mm [33.1, 68.8]; p = 0.043, severe calcification at target lesion: 90.0% vs. 68.2%; p = 0.047, and median arc calcification 360.0° [297.5, 360.0] vs. 360.0° [180.0, 360.0]; p = 0.033). Technical success was achieved in 93.3% vs. 81.8% (p = 0.187) in IVL- and TAX-TAVI and the safety outcome occurred in 10.0% vs. 31.8% in IVL- and TAX-TAVI (p = 0.047), respectively. (4) Conclusions: IVL-assisted transfemoral TAVI was feasible and safe with favorable outcomes compared to TAX-TAVI. IVL may further expand the number of patients eligible for transfemoral TAVI and may help overcome limitations of an alternative access.

15.
Adv Ther ; 41(7): 2936-2952, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38833144

RESUMO

INTRODUCTION: Hair loss is driven by multiple factors, including genetics. Androgenetic alopecia (AGA) is a condition in which treatments necessitate prolonged compliance with prescribed medications. We have developed IVL3001, a long-acting injectable (LAI) formulation of finasteride encapsulated within poly lactic-co-glycolic acid microspheres, to enhance the efficacy of the finasteride and to achieve consistent positive outcomes in adults. An open-label, sequential, single-dose phase I clinical trial was designed to evaluate the safety, pharmacokinetic (PK), and pharmacodynamic (PD) of IVL3001. METHODS: A total of 40 non-smoking, healthy adult males were divided into three cohorts where the IVL3001 group received a single subcutaneous injection of 12-36 mg IVL3001 and 1 mg finasteride (Propecia®) once daily for 28 days. The plasma concentrations of finasteride, dihydrotestosterone (DHT), and testosterone were measured using liquid chromatography-tandem mass spectrometry. The tolerability of the injections was assessed, and compartment models were developed to predict the effective dose and assess PK/PD profiles. RESULTS: IVL3001 and finasteride 1 mg tablets were well tolerated. IVL3001 showed consistent plasma concentrations without bursts or fluctuations. Consistent with its mechanism of action, IVL3001 reduced DHT levels. Simulation data showed that the administration of 12-36 mg of IVL3001 every 4 weeks achieved plasma concentrations similar to finasteride, with comparable DHT reduction. CONCLUSION: The present study represents the first clinical trial to evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD), and tolerability of finasteride long-acting injectables (LAI) in adults. The rapid onset of action sustained effective drug concentration and the prolonged half-life of IVL3001 suggest that it offers multiple benefits over conventional oral formulations in terms of therapeutic response and compliance. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04945226.


Assuntos
Inibidores de 5-alfa Redutase , Alopecia , Finasterida , Humanos , Finasterida/farmacocinética , Finasterida/administração & dosagem , Finasterida/efeitos adversos , Alopecia/tratamento farmacológico , Masculino , Adulto , Inibidores de 5-alfa Redutase/farmacocinética , Inibidores de 5-alfa Redutase/administração & dosagem , Inibidores de 5-alfa Redutase/efeitos adversos , Inibidores de 5-alfa Redutase/farmacologia , Di-Hidrotestosterona/farmacocinética , Di-Hidrotestosterona/administração & dosagem , Di-Hidrotestosterona/sangue , Pessoa de Meia-Idade , Preparações de Ação Retardada , Testosterona/farmacocinética , Testosterona/sangue , Injeções Subcutâneas , Adulto Jovem , Microesferas
16.
J Vasc Access ; : 11297298231222051, 2024 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-38205610

RESUMO

INTRODUCTION: The first-choice vascular access to starting dialysis in patients with End Stage Renal Disease (ESRD) is autogenous distal arteriovenous-fistula (AVF) to spare vascular district avoiding proximal fistula complications. One of most significant exclusion criteria to create distal AVF is still now the presence of huge calcification of the feeding artery due to large numbers of early failure (EF) and failure in maturation (FTM). In recent years the possibility to use new devices able to deliver intravascular lithotripsy (IVL) to treat high calcified stenosis could be a possibility to recruit these marginal arteries to create distal AVF. METHODS: ESRD patients with totally calcified radial artery wall were enrolled to participate to this prospective, single arm, multicentric study. The selected patients were treated with intraoperative IVL at surgical time, during anastomosis creation to soften calcified radial artery. Patients were followed 1 month after surgery with eco-doppler, for flow and vessels maturation assessment. At 3 month was investigated how many patients have started dialysis treatment with two needle cannulation and good efficiency. RESULTS: Nineteen distal forearm radio-cephalic fistula were built in 19 patients. One-month doppler assessment showed mean AVF flow of 743 ml/min and efferent vein caliper of 6.46 mm. At 3 months 14 patient have started stable 2 needles dialysis (other three patients were not yet dialysis dependent CKD). Were observed one immediate failure, one failure in maturation, and two late failures at 4 and 16 months respectively. Sixteen months primary and secondary patency was 78.9% and 89.5% respectively. CONCLUSION: These results showed how intraoperative IVL could help to recruit huge calcified marginal artery to create autogenous distal forearm AVF, avoiding proximal AVF, risking distal ischemia syndrome, and sparing vascular district to eventually rebuilt more proximal AVF in future.

17.
Ther Adv Cardiovasc Dis ; 18: 17539447241263444, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39049591

RESUMO

Percutaneous coronary intervention (PCI) of calcified coronary arteries is associated with poor outcomes. Poorly modified calcified lesion hinders the stent delivery, disrupts drug-carrying polymer, impairs drug elution kinetics and results in under-expanded stent (UES). UES is the most common cause of acute stent thrombosis and in-stent restenosis after PCI of calcified lesions. Angiography has poor sensitivity for recognition and quantification of coronary calcium, thereby mandating the use of intravascular imaging. Intravascular imaging, like intravascular ultrasound and optical coherence tomography, has the potential to accurately identify and quantify the coronary calcium and to guide appropriate modification device before stent placement. Available options for the modification of calcified plaque include modified balloons (cutting balloon, scoring balloon and high-pressure balloon), atherectomy devices (rotational atherectomy and orbital atherectomy) and laser atherectomy. Coronary intravascular lithotripsy (IVL) is the newest addition to the tool box for calcified plaque modification. It produces the acoustic shockwaves, which interact with the coronary calcium to cause multiplanar fractures. These calcium fractures increase the vessel compliance and result in desirable minimum stent areas. Coronary IVL has established its safety and efficacy for calcified lesion in series of Disrupt CAD trials. Its advantages over atherectomy devices include ease of use on workhorse wire, ability to modify deep calcium, no debris embolization causing slow flow or no-flow and minimal thermal injury. It is showing promising results in modification of difficult calcified lesion subsets such as calcified nodule, calcified left main bifurcation lesions and chronic total occlusion. In this review, authors will summarize the mechanism of action for IVL, its role in contemporary practice, evidence available for its use, its advantages over atherectomy devices and its imaging insight in different calcified lesion scenarios.


Shock the rock with coronary intravascular lithotripsyPresence of coronary calcium during stenting is associated with the risk of stent under expansion. It's imperative to adequately modify this coronary calcium before placing the stent. Till recent past, the most effective method for calcium modification is debulking it with rotational artherectomy, which is associated with the risk of coronary perforation, slow flow or abrupt vessel closure. Recently, a balloon-based lithotripsy device has established its safety and efficacy for treating such lesions. Coronary intravascular lithotripsy (IVL) is an easy to use calcium modification device and is associated with almost negligible complications, when compared with artherectomy devices. In this review, we will discuss the mechanism of IVL action and its use in different scenarios of calcified coronary artery disease.


Assuntos
Doença da Artéria Coronariana , Litotripsia , Calcificação Vascular , Humanos , Litotripsia/efeitos adversos , Calcificação Vascular/terapia , Calcificação Vascular/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Doença da Artéria Coronariana/diagnóstico por imagem , Resultado do Tratamento , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Stents , Vasos Coronários/diagnóstico por imagem , Fatores de Risco , Placa Aterosclerótica , Ultrassonografia de Intervenção
18.
Diagnostics (Basel) ; 14(13)2024 Jul 06.
Artigo em Inglês | MEDLINE | ID: mdl-39001332

RESUMO

A 43-year-old patient with a history of uterine fibromatosis was referred to our hospital for menometrorrhagia and pelvic pain. At the pelvic ultrasound, a highly-vascularized myometrial lesion in volumetric increase was described. An elongated, solid, hypoechoic, painless, and highly vascularized left parauterine mass was identified. On histological examination, a uterine smooth muscle tumor of uncertain malignant potential (STUMP) with intravascular invasion of the left uterine vein was diagnosed. The adnexa and peritoneum were free of disease. On a retrospective evaluation of the ultrasound images, we noticed that the intravascular lesion showed sonographic features comparable to the original mass. Moreover, the Color Doppler (CD) analysis revealed an interrupted blood flow within the left uterine vein. In this case, the ultrasound proved to be an accurate diagnostic tool. When inhomogeneous uterine masses are suspected, and a parauterine/paraadnexal mass surrounded by irregular vessels are identified, the sonographer should take into account a risk of intravascular invasion. The patency of uterine and ovarian vessels should be accurately evaluated, to guide a tailored patient surgical approach.

19.
J Cardiothorac Surg ; 18(1): 256, 2023 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-37658366

RESUMO

BACKGROUND: Intravascular leiomyomatosis (IVL) is a histologically benign smooth muscle tumor arising from the uterus that can spread through the pelvic veins and, on rare occasions, extend as far as the heart via the inferior vena cava. Despite its benign characteristics, it can behave like a malignant tumor leading to significant morbidity and even mortality if left untreated. CASE PRESENTATION: The patient is a 42-year-old woman with a past medical history of uterine leiomyomas. She presented with heavy bleeding and frequent spotting; therefore, she went to her gynecologist. After further evaluation, a mass within the uterus that expanded into the pelvic veins, inferior vena cava, and right atrium was discovered. After the complete removal of the mass, the patient underwent full recovery. IVL with cardiac extension was the final diagnosis. CONCLUSION: Although IVL is rare, it must be considered in women who underwent previous hysterectomies or myomectomies and present with symptoms of right heart failure. The ideal therapy will need the aid of a multidisciplinary team and will depend on the patient's symptoms, previous operative history, the tumor's extension, and resectability.


Assuntos
Insuficiência Cardíaca , Leiomiomatose , Feminino , Humanos , Adulto , Leiomiomatose/diagnóstico por imagem , Leiomiomatose/cirurgia , Átrios do Coração/cirurgia , Veia Cava Inferior/cirurgia , Ginecologista
20.
Cancer Diagn Progn ; 3(1): 31-37, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36632582

RESUMO

BACKGROUND: Intravascular large B-cell lymphoma (IVLBCL) is a rare subtype of extranodal B-cell lymphoma, which has traditionally been associated with poor outcomes. Despite increasing recognition, IVLBCL requires a high degree of clinical suspicion on the part of the clinician for its diagnosis. CASE SERIES: We present four patient cases: A 69-year-old female with constitutional symptoms and cognitive decline; a 78-year-old female with kidney injury and constitutional symptoms whose disease rapidly progressed to multiorgan failure and death; a 70-year-old asymptomatic female with an incidentally found, enlarged thyroid; and a 63-year-old male with cytopenia and constitutional symptoms. Retrospective chart analysis was performed on these four patients diagnosed with IVLBCL at our Institute to identify the pathognomonic features of the disease and compare these to the published evidence. IVLBCL has a heterogeneous presentation, as seen in our four patients. The disease is characterized by the exclusive presence of malignant cells inside the blood vessels and lack of organ infiltration. Traditional preliminary diagnostic modalities such as imaging are usually inconclusive, given the paucity of lymphomatous aggregates. A bone marrow biopsy, random skin biopsies, or a focal organ biopsy in appropriate cases is required for diagnosis. Immunosuppression might play a role in the pathogenesis. Timely initiation of aggressive cancer-directed therapy was associated with improved outcomes. Monitoring for disease response and relapse continues to be a challenge. CONCLUSION: Our mini-series highlights the significance of timely diagnosis and intervention in IVLBCL and emphasizes the importance of further research to determine its association with immunosuppression.

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