Transurethral Resection of Non-Muscle Invasive Bladder Tumors Combined with Fluorescence Diagnosis and Photodynamic Therapy with Chlorin e6-Type Photosensitizers

Bladder cancer is a common disease with a high recurrence rate. In order to improve the treatment of superficial bladder tumors, we evaluated the efficacy and safety of transurethral resection (TURB) followed by fluorescence diagnosis (FD) and photodynamic therapy (PDT) with chlorin e6 photosensitizers (PSs), viz. “Fotoran e6” and “Fotoditazin”. It was found that both PSs generated singlet oxygen and revealed moderate affinity toward the lipid-like compartment. Between November 2018 and October 2020, 12 patients with verified non-muscle invasive bladder cancer (NMIBC) were treated by TURB combined with FD and PDT. Eight patients received “Fotoran e6” intravenously, while four patients received intravesical PSs. The patient ages were between 31 and 79 years, with a median age of 64.5 years (mean 61.3 ± 14.2). The total light dose was 150 J/cm2 for the local irradiation of the tumor bed with a red light at the λ = 660 nm wavelength, and 10–25 J/cm2 were additionally delivered for diffuse irradiation of the entire bladder mucosa. At the median follow-up period of 24 months (mean 24.5 ± 5.4 months, range 16–35 months), 11 patients remained tumor-free. One 79-year-old patient developed a recurrence without progression to the muscle layer. This pilot study shows that the TURB + FD + PDT technique is an effective and safe option for the first-line treatment of superficial bladder tumors

Amended STRONG-HF study design

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Safety, Tolerability and efficacy of Rapid Optimization, helped by NT-proBNP and GDF-15, of Heart Failure therapies (STRONG-HF): rationale and design for a multicentre, randomized, parallel-group study

Aims Patients admitted for acute heart failure (HF) are at high risk of readmission and death, especially in the 90 days following discharge. We aimed to assess the safety and efficacy of early optimization of oral HF therapy with beta‐blockers (BB), angiotensin‐converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) or angiotensin receptor–neprilysin inhibitors (ARNi), and mineralocorticoid receptor antagonists (MRA) on 90‐day clinical outcomes in patients admitted for acute HF. Methods In a multicentre, randomized, open‐label, parallel‐group study, a total of 900 patients will be randomized in a 1:1 ratio to either ‘usual care’ or ‘high‐intensity care’. Patients enrolled in the usual care arm will be discharged and managed according to usual clinical practice at the site. In the high‐intensity care arm, doses of oral HF medications – including a BB, ACEi or ARB, and MRA – will be up‐titrated to 50% of recommended doses before discharge and to 100% of recommended doses within 2 weeks of discharge. Up‐titration will be delayed if the patients develop worsening symptoms and signs of congestion, hyperkalaemia, hypotension, bradycardia, worsening of renal function or significant increase in N‐terminal pro‐B‐type natriuretic peptide between visits. The primary endpoint is 90‐day all‐cause mortality or HF readmission. Conclusions STRONG‐HF is the first study to assess whether rapid up‐titration of evidence‐based guideline‐recommended therapies with close follow‐up in a large cohort of patients discharged from an acute HF admission is safe and can affect adverse outcomes during the first 90 days after discharge