Evaluation of the safety and efficacy of a novel Anatomical classification and dUal anchoRing theory to Optimize the tavR strategy for pure severe Aortic regurgitation (AURORA): a prospective cohort study.

BACKGROUND: Success rate of transcatheter aortic valve replacement (TAVR) in aortic regurgitation (AR) patients is relatively low on account of the absence of calcified anchoring structures. Morphological classification and corresponding TAVR strategies for AR are lacking yet. METHODS: The AURORA study is a prospective, multicenter, single-arm cohort study to evaluate the safety and efficacy of transfemoral TAVR for severe AR in patients with high or prohibitive risk for surgery. Patients who are ≥ 65 years and diagnosed with severe pure AR as defined by the Echocardiographic Core Laboratory will be consecutively enrolled for further multidetector computed tomography (MDCT) scanning and multiplanar analyses. Based on a new anatomical classification and dual anchoring theory, patients will be classified into 4 types according to the level of the anchoring area. Types 1, 2 and 3 (at least 2 anchoring areas) will undergo the TAVR procedure with a domestic Chinese self-expanding valve (VitaFlow Valve, MicroPort, Shanghai, China), whereas type 4 (0 or 1 anchoring area) patients will be considered unsuitable for TAVR and will receive medical treatment. Our goal is to recruit 100 patients to account for 10% missing data or loss of patients to follow-up. Procedural, 30-day, 6-month and 12-month outcomes will be assessed according to Valve Academic Research Consortium-3 criteria. DISCUSSION: The AURORA study will establish a new AR anatomical classification based on dual anchoring theory through MDCT multiplanar measurement and assess the safety and efficacy of TAVR guided by this new classification and strategy in AR patients. TRIAL REGISTRATION: This Study was registered at Chinses Clinical Trial Registry. The registration number: ChiCTR2200055415; The date of registration: 9, January 2022; The URL of the registration: http://www.chictr.org.cn/showproj.aspx?proj=141209 .

Based on SEER Database: Population Distribution, Survival Analysis, and Prognostic Factors of Organ Metastasis of Lung Large Cell Neuroendocrine Carcinoma.

Background: The incidence rate of lung large cell neuroendocrine carcinoma (LCNEC) in lung cancer is low, but the malignancy is high and the prognosis is poor. We used the Surveillance, Epidemiology, and End Results (SEER) database to determine the population distribution of organ metastasis in LCNEC, conduct survival analysis, judge prognostic factors, and provide direction for follow-up diagnosis and treatment. Materials and methods: By logging into the SEER database, the data of lung LCNEC were retrieved and the target population was selected. According to the presence or absence of organ metastasis (bone, brain, liver, and lung), we divided the target population into the no organ metastasis group (n = 1,202) and the organ metastasis group (n = 870). By analyzing the clinicopathological data of patients and using the survival function, the corresponding median survival time was obtained, and the influencing factors of each group were analyzed. Then, the significant influencing factors were analyzed by multivariate Cox regression analysis to screen out the independent influencing factors. Result: In the overall sample group, multivariate Cox regression analysis showed that sex, age, primary site surgery, bone metastasis, brain metastasis, liver metastasis, radiotherapy, and chemotherapy were independent prognostic factors. The 1-year survival rate was 13.8% in the bone metastasis group, 19.1% in the brain metastasis group, 13.8% in the liver metastasis group, and 20.3% in the intrapulmonary metastasis group. In the organ metastasis group, multivariate Cox regression analysis showed that sex, chemotherapy, radiotherapy sequence with surgery, primary site surgery, liver metastasis, and age at diagnosis were independent factors affecting the prognosis. Conclusion: In the overall sample of LCNEC, bone metastasis, brain metastasis, and liver metastasis all reduced the overall survival time, while the effect of intrapulmonary metastasis on the overall survival time was not statistically significant. Sex, chemotherapy, radiotherapy sequence with surgery, primary site surgery, liver metastasis, and age were independent factors affecting the prognosis of the LCNEC organ metastasis group. Women, chemotherapy, and radiotherapy sequence with surgery were favorable factors, while old age, liver metastasis, and male were unfavorable factors.

Prevention of contrast-induced nephropathy by adequate hydration combined with isosorbide dinitrate for patients with renal insufficiency and congestive heart failure.

BACKGROUND: Adequate hydration remains the mainstay of contrast-induced nephropathy prevention, and nitrates could reduce cardiac preload. HYPOTHESIS: This study aimed to explore the adequate hydration with nitrates for patients with chronic kidney disease (CKD) and congestive heart failure (CHF) to reduce the risk of contrast-induced nephropathy (CIN) and at the same time avoid the acute heart failure. METHODS: Three hundred and ninty-four consecutive patients with CKD and CHF undergoing coronary procedures were randomized to either adequate hydration with nitrates (n = 196) or to routine hydration (control group; n = 198). The adequate hydration group received continuous intravenous infusion of isosorbide dinitrate combined with intravenous infusion of isotonic saline at a rate of 1.5 mL/kg/h during perioperative period. The definition of CIN was a 25% or 0.5 mg/dL rise in serum creatinine over baseline. This trial is registered with www.clinicaltrials.gov, number NCT02718521. RESULTS: Baseline characteristics were well-matched between the two groups. CIN occurred less frequently in adequate hydration group than the control group (12.8% vs 21.2%; P = 0.018). The incidence of acute heart failure did not differ between the two groups (8 [4.08%] vs 6[3.03%]; P = 0.599). Cumulative major adverse events (death, myocardial infarction, stoke, hospitalization for acute heart failure) during the 90-day follow-up were lower in the adequate hydration with nitrates group (P = 0.002). CONCLUSIONS: Adequate hydration with nitrates can safely and effectively reduce the risk of CIN in patients with CKD and CHF.

[Ex vivo assessment of coronary lesions by optical coherence tomography and intravascular ultrasound in comparison with histology results].

OBJECTIVE: To explore the diagnostic accuracy of optical coherence tomography (OCT) and intravascular ultrasound (IVUS) in the detection of ex vivo coronary plaques with different compositions compared with histology results. METHODS: OCT and IVUS were performed in 15 autopsied heart specimens and the isolated coronary artery was assessed by routine histological processing thereafter. Coronary plaques were classified into 3 types (lipid-rich plaque, calcified plaque and fibrous plaque) according to standard criteria respectively. Sensitivity and specificity for detection of different types of plaque by OCT and IVUS were calculated according histology results. RESULTS: Seventy seven coronary plaques were analyzed. OCT demonstrated a sensitivity and specificity of 69% and 88% for lipid-rich plaque, 93% and 92% for calcified plaque, 88% and 98% for fibrous plaque. IVUS demonstrated a sensitivity and specificity of 61% and 92%, 98% and 97%, 68% and 90% respectively. The agreement between OCT and IVUS in assessment of coronary plaque was 0.831 (Kappa = 0.72, P < 0.01). CONCLUSIONS: Both OCT and IVUS correctly detected ex vivo coronary plaques and there was a good agreement in assessment of coronary plaques between OCT and IVUS. OCT is superior to IVUS in assessment of fibrous plaque and is similar as IVUS in assessment of calcified plaque.

[Clinical efficacy of transcatheter renal arterial embolization plus cryoablation for medium and advanced renal carcinomas].

OBJECTIVE: To investigate the clinical efficacy of transcatheter renal arterial embolization (TRAE) plus cryoablation in the treatment of medium and advanced stage renal carcinomas. METHODS: The patients with medium and advanced stage renal carcinomas were randomized into 2 groups: TRAE group (A, n = 53) and TRAE plus cryoablation group (B, n = 51) undergoing cryoablation 2 - 3 weeks after TRAE. A total of 128 tumors (8.7 ± 3.2) (4.0 - 19.8) cm in diameter were detected. And the largest tumor in a specific patient with multiple lesions was selected for observation. At pre- and post-treatment, their clinical symptoms, kidney function and tumor diameters (computed tomography or magnetic resonance imaging) were observed. And their post-treatment profiles of tumor necrosis and survival were assessed. RESULTS: There was no difference in gender, age, size and Robson stage between two groups. The tumor necrosis of Group B was significantly higher than that of Group A (61% vs 35%, t = 6.784, P < 0.01). The median survival duration of Group B was significantly longer than that of Group A (24 vs 15 months, P < 0.05). There was no significant change of kidney function at pre- and post-treatment (P > 0.05). The quality-of-life scores improved at post-treatment (P < 0.01). CONCLUSION: As compared with TRAE therapy alone, the combination of TRAE and cryoablation may improve the tumor necrosis rate and prolong the patient survival duration.

[Experimental study on the immune functions of splenic dendritic cells after a combined therapy of cryoablation and granulocyte macrophage-colony stimulating factor for prostate cancer].

OBJECTIVE: To assess the changes about numbers and immune functions of splenic DC (dendritic cell) after a combined therapy of cryoablation and GM-CSF (granulocyte macrophage-colony stimulating factor) for prostate cancer. METHODS: Murine model of prostate cancer was established. And the tumor-bearing mice were divided into 4 groups: control group (Group A), GM-CSF treatment (Group B), cryoablation treatment (Group C) and a combined therapy of cryoablation and GM-CSF (Group D). Spleens were sampled before and 7, 14, 21 days after treatment. Immunohistochemistry of DC was performed. And splenic lymphocytes were isolated and their activated percents analyzed by flow cytometry. The tumor-specific cytolytic activity of cytotoxic T lymphocyte (CTL) was measured by LDH (lactate dehydrogenase) assay. And the lung metastasis rates were calculated. RESULTS: At Day 7 post-treatment, the number of DC per high-power field was 26.4 ± 1.1, 36.6 ± 2.1, 25.8 ± 1.3 and 58.2 ± 1.9 (P < 0.05); the activated percent of DC 13.60% ± 1.67%, 9.50% ± 0.21%, 14.40% ± 1.14% and 32.80% ± 2.39% (P < 0.05); cytolytic activity of CTL against prostate cancer cells 7.76% ± 0.11%, 8.10% ± 0.92%, 9.38% ± 0.45% and 41.68% ± 0.82% in Groups A, B and C respectively (P < 0.05). At Day 21 post-treatment, the rate of lung metastasis was 5/5, 4/5, 4/5 and 1/5 respectively. CONCLUSION: A combined therapy of cryoablation and GM-CSF may increase the number and activated percent of DC in spleen, enhance the tumor-specific immune responses and decrease lung metastasis rate.

[Effect of transcatheter renal arterial embolization combined with cryoablation on regulatory CD4+ CD25+ T lymphocytes in the peripheral blood of patients with advanced renal carcinoma].

OBJECTIVE: To analyze the effect of Argon-Helium cryosurgery (AHCS) combined with transcatheter renal arterial embolization (TRAE) on the differentiation of regulatory CD4+ CD25+ T cell (Treg) and its implication in patients with renal carcinoma. METHODS: 77 patients were called in the study, and were divided into two groups: TRAE group (n = 45, receiving TRAE only) and TRAE + cryoablation group (n = 32, receiving cryoablation 2-3 weeks after TRAE). The percentage of Treg cells and T lymphocyte subsets (CD3+T, CD4+T, CD8+T, and CD4+T/CD8+ T) in the peripheral blood was measured by flow cytometry before and 3 months after therapy. Meanwhile, the extent of tumor necrosis was measured by MRI or CT 1 month after therapy. RESULTS: The percentages of Treg cells of patients in TRAE + cryoablation group were decreased from 6.6% +/- 1.2% to 3.9% +/- 1.2%, (t = 42.768, P < 0.01), and the percentages of CD3+ T, CD4+ T, CD8+T, NK and CD4+T/CD8+T were significantly increased (P < 0.01). However, among the patients in TRAE group, the percentages of Treg, CD3+ T, CD4+ T, CD8+T, NK and CD4+T/CD8+T were increased (P > 0.05). The tumor necrosis rates of TRAE + cryoablation groups were 57.5%, significantly higher than those of TRAE group, which shows 31.6% (t = 6.784, P < 0.01). The median survival duration of the TRAE + cryoablation group was 20 months, significantly longer than that of the TRAE group (chi(2) = 7.368, P < 0.01). The decreasing extent of Treg cells is correlated with tumor necrosis rates (r = 0.90 P < 0.01) and life time (r = 0.67 P < 0.01). CONCLUSION: The therapy of TRAE combined with cryoablation contributed to reduce the percentage of Treg cells and improve the immune situation of patients with renal cell carcinoma, consequently increase tumor necrosis rate and prolongs the patients' survival duration.