Transperineal laser ablation of the prostate as a treatment for benign prostatic hyperplasia and prostate cancer: The results of a Delphi consensus project.

Objective: To evaluate transperineal laser ablation (TPLA) with Echolaser® (Echolaser® TPLA, Elesta S.p.A., Calenzano, Italy) as a treatment for benign prostatic hyperplasia (BPH) and prostate cancer (PCa) using the Delphi consensus method. Methods: Italian and international experts on BPH and PCa participated in a collaborative consensus project. During two rounds, they expressed their opinions on Echolaser® TPLA for the treatment of BPH and PCa answering online questionnaires on indications, methodology, and potential complications of this technology. Level of agreement or disagreement to reach consensus was set at 75%. If the consensus was not achieved, questions were modified after each round. A final round was performed during an online meeting, in which results were discussed and finalized. Results: Thirty-two out of forty invited experts participated and consensus was reached on all topics. Agreement was achieved on recommending Echolaser® TPLA as a treatment of BPH in patients with ample range of prostate volume, from <40 mL (80%) to >80 mL (80%), comorbidities (100%), antiplatelet or anticoagulant treatment (96%), indwelling catheter (77%), and strong will of preserving ejaculatory function (100%). Majority of respondents agreed that Echolaser® TPLA is a potential option for the treatment of localized PCa (78%) and recommended it for low-risk PCa (90%). During the final round, experts concluded that it can be used for intermediate-risk PCa and it should be proposed as an effective alternative to radical prostatectomy for patients with strong will of avoiding urinary incontinence and sexual dysfunction. Almost all participants agreed that the transperineal approach of this organ-sparing technique is safer than transrectal and transurethral approaches typical of other techniques (97% of agreement among experts). Pre-procedural assessment, technical aspects, post-procedural catheterization, pharmacological therapy, and expected outcomes were discussed, leading to statements and recommendations. Conclusion: Echolaser® TPLA is a safe and effective procedure that treats BPH and localized PCa with satisfactory functional and sexual outcomes.

Transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a feasibility study. Results at 6 and 12 months from a retrospective multi-centric study.

PURPOSE: To investigate the effectiveness and safety of SoracteLite™-transperineal percutaneous laser ablation (TPLA) in the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) at 6 and 12 months follow-up. METHODS: Patients with urinary symptoms secondary to BPH underwent TPLA under local anesthesia in four centers. Under US guidance, up to four 21G applicators were inserted in the prostatic tissue. Each treatment was performed with diode laser operating at 1064 nm changing the illumination time according to prostate size. The primary end-points of this study were change in IPSS, PVR, Qmax, QoL, and prostatic volume at 6 an 12 months from SoracteLiteTM TPLA treatment. Secondary end-point was the assessment of complications. RESULTS: Analysis was performed on data 160 patients (mean age 69.8 ± 9.6 years) with at least 6 months follow and of 83 patients (mean age 67.9 ± 8.7 years) with at least 12 months follow-up. At 6 months, IPSS improved from 22.5 ± 5.1 to 7.7 ± 3.3 (P < 0.001), PVR from 89.5 ± 84.6 to 27.2 ± 44.5 ml (P < 0.001), Qmax from 8.0 ± 3.8 to 14.3 ± 3.9 ml/s (P < 0.001), QoL from 4.5 ± 1.1 to 1.8 ± 1.0 (P < 0.001), volume from 75.0 ± 32.4 to 60.3 ± 24.5 ml (P < 0.001). At 12 months, IPSS improved from 22.5 ± 4.5 to 7.0 ± 2.9 (P < 0.001), PVR from 71.7 ± 93.9 to 17.8 ± 51.0 ml (P < 0.001), Qmax from 8.6 ± 5.2 to 15.0 ± 4.0 ml/s (P < 0.001), QoL from 4.2 ± 0.6 to 1.6 ± 0.9 (P < 0.001), volume from 87.9 ± 31.6 to 58.8 ± 22.9 ml (P < 0.001). 7/160 (4.3%) grade I and 1/160 (0.6%) grade III complication occurred. CONCLUSIONS: SoracteLite™ TPLA allows significant improvement of IPSS, Qol, Qmax, PVR, and reduction of prostatic volume at 6 and 12 months.

Association between selenium and lycopene supplementation and incidence of prostate cancer: Results from the post-hoc analysis of the procomb trial.

BACKGROUND: Many potential chemopreventive agents have been used in PCa prevention, including selenium (Se) and lycopene (Ly). However, their role has been matter of debate over the years, due to potential of promotion of PCa. PURPOSE: In this study we aimed at evaluating the incidence risk of prostate cancer (PCa) in a cohort of patients treated with Se and Ly. METHODS: The Procomb trial design has been previously published (ISRCTN78639965). From April 2012 to April 2014 209 patients were followed and underwent prostate biopsy when PSA ≥4 ng/ml and/or suspicion of PCa. The all cohort was composed by patients treated with Se and Ly (Group A = 134 patients) and control (Group B = 75 patients). RESULTS: During the follow-up time of 2 years, a total of 24 patients (11.5%) underwent prostate biopsy, of which 9 (4.3%) where diagnosed with PCa and 15 (7.2%) where diagnosed with benign prostatic hyperplasia. We did not observe statistical differences in terms of mean changes of PSA between the two groups (p-value for trend = 0.33). The relative risk (RR) for PCa was 1.07 and 0.89 in group A and B, respectively (p = 0.95). At the multivariate Cox regression analysis supplementation with Se and Ly was not associated with greater risk of PCa (hazard ratio: 1.38; p = 0.67). CONCLUSION: In this analysis we did not show evidences supporting a detrimental role of Selenium and Lycopene supplementation in increasing PCa after 2 years of therapy, nor supporting a protective role.

[Management of electrical storm in implantable cardioverter-defibrillator recipients]. / La gestione della tempesta aritmica nel paziente portatore di defibrillatore impiantabile.

The term "electrical storm" (ES) indicates a state of cardiac electrical instability manifested by several episodes of ventricular tachyarrhythmias (VTs) within a short time. In patients with an implantable cardioverter-defibrillator (ICD), ES is best defined as three appropriate VT detections in 24h, treated by antitachycardia pacing, shock or eventually untreated but sustained in a VT monitoring zone. ES seems to have a low immediate mortality (1%) but frequently (50-80%) leads to hospitalization. Antiarrhythmic drugs have been shown to be very effective in treating ES in patients without ICD, whereas in ICD recipients, device programming is probably a key issue to prevent ES. Since sympathetic overreactivity is an important trigger, the risk of shock delivery should be minimized. Antitachycardia pacing can successfully terminate a significant percentage of fast VTs. Important parameters such as the number of VT cycles needed for VT detection can be increased from nominal values to allow spontaneous termination, and safety features that deliver a shock after a programmable time window independent of programming of antitachycardia pacing (sustained rate duration) should be prolonged or disabled. In some cases it may be advisable to turn off the ICD tachy mode to avoid multiple ineffective shocks. Substrate mapping and VT ablation may be useful for the treatment and prevention of ES.

[Responsibilities for the remote monitoring of heart failure patients]. / La responsabilità nel controllo a distanza del paziente con scompenso cardiaco.

Heart failure patients may frequently undergo repeat hospitalizations, and for this reason recent guidelines recommend a multidisciplinary approach including remote clinical state management through systems such as electronic devices, portable or implantable, with the aim of simplifying patient management and optimizing healthcare resources. This different way of healthcare organization has brought about new levels of responsibility, including device manufacturers responsible for the technical aspects, healthcare facilities responsible for the information systems used for patient clinical data transmission and for ambulatory patient access, and in particular the clinicians who should ensure the process supervision by providing prompt medical assistance if alarm signals are received. The use of telemedicine, however, may engender technical problems of varying difficulties. In terms of responsibility, service providers are not liable for damage deriving from technical default, except in the case of willful misconduct or gross negligence. No less important are the legal issues concerning permissions, conflicts of jurisdiction among nations, problems of service inaccessibility, as well as the identification of medical liability in relation to the activity of a multidisciplinary team, besides issues relating to informed consent and privacy protection. In conclusion, risk management with telemedicine may provide more accurate information and better traceability of operators' activity.

Cavernous body reduction in four patients with erectile dysfunction due to insufficient venous occlusion and a deficit of elastic fibers in the tunica albugínea

INTRODUCTION: The corpora cavernosa are cylindrical vessels containing fluid under pressure. Thus, if cavernous wall resistance decreases, the radius increases and internal pressure decreases (LaPlace's law). We reasoned that if we decrease the corpus cavernosum radius, by excising a strip from each tunica albuginea, intracavernous pressure would increase during erection. MATERIALS AND METHODS: We treated with this procedure, four patients (mean age 41.5) with long-standing erectile dysfunction due to veno-occlusive dysfunction, non-responders to phosphodiesterase-5 inhibitors and intracavernous PGE1 injection. RESULTS: Two months post-surgery, intracavernous PGE1 (40 mcg) induced a satisfactory erection in two patients and a 45 percent and 58 percent tumescence in the other two. PGE1 responders also responded to 100 mg sildenafil. After 100 mg sildenafil and 20 mg tadalafil, the two non-responders had erections that enabled penetration but were short lasting. CONCLUSION: The procedure described could be more effective than cavernous revascularization operations. The results seem to confirm the mathematical assumptions.

Laboratory assessment.

Nephrolithiasis has a multifactorial origin, and several disorders may coexist in the same patient. We made a basic and a specific laboratory evaluation. The complete metabolic evaluation consisted of a serum chemistry panel: blood sugar level, complete hemogram, serum electrolytes, GOT, GPT, calcium, phosphate, uric acid, and creatinine levels and RIA dosage of PTH, vitamin D3, cAMP, FT4, FT3 and TSH. The complete analyses of random urinalysis and culture are: (1) dip-stick test: pH, leukocytes/bacteria and Brand's test, and (2) 24-hour urine collection: calcium, magnesium, oxalate, phosphate, citrate, urea, urate, sodium, creatinine, chloride, potassium. It is possible with these tests to identify secondary causes of nephrolithiasis and uncover coexisting problems that may have an impact on patient management. The future for diagnosis, prevention and therapy will be the identification of genetic alterations and related specific dosage.

Actual chemotherapeutical possibilities in hormone-refractory prostate cancer (HRPC) patients.

Androgen deprivation therapy still remains the gold standard in the treatment of advanced prostate cancer. Unfortunately, patients with metastatic prostate cancer treated with androgen deprivation therapy frequently develop androgen-independent prostate cancer. Cytotoxic chemotherapy has not been used routinely and the current standard regimens have not demonstrated any significant alteration in the development of hormone-refractory disease. Recent phase III randomized clinical trials have suggested that docetaxel-based therapy, demonstrating a real increase of survival in treated patients, could represent the new standard treatment for metastatic patients. There is also promising activity of new drug combinations, such as taxanes plus vinca alkaloids, and of classic chemotherapeutic agents plus biological drugs. This review focuses on the current therapies for the treatment of HRPC.

Prostate cancer treatment and quality of life.

Prostate cancer is detected today at earlier stages and in younger men than ever before. A lot of men are asymptomatic and also physically and sexually active at diagnosis, and most of them are being treated by curative procedures. These trends have led to increasing numbers of patients undergoing disease management for longer periods of time. For many patients quality of life (QoL) may be just as important as survival. Thus, QoL considerations may well be the critical factor in medical decision-making for most of them. Widespread interest in studying patient-centred outcomes has led to the development of methods for health-related QoL measurements. In fact, many questionnaires have been introduced in clinical practice to assess the impact of QoL in patients (SF-36, CARES, FACT, EORTC QLQ-C30, GRISS, UCLA PCI, PCOS). Herein we evaluate the impact of QoL on patients affected by prostate cancer and treated with watchful waiting, radical prostatectomy, radiotherapy and hormonal therapy; we have also considered the role of supportive care, including the administration of analgesics, antidepressants, corticosteroids, bisphosphonates, antiemetics and stool softeners, together with psychological support. The ultimate goal of QoL research should strongly improve medical care and concretely assist patients and physicians in treatment decision-making.

Cavernous body reduction in four patients with erectile dysfunction due to insufficient venous occlusion and a deficit of elastic fibers in the tunica albuginea.

INTRODUCTION: The corpora cavernosa are cylindrical vessels containing fluid under pressure. Thus, if cavernous wall resistance decreases, the radius increases and internal pressure decreases (LaPlace's law). We reasoned that if we decrease the corpus cavernosum radius, by excising a strip from each tunica albuginea, intracavernous pressure would increase during erection. MATERIALS AND METHODS: We treated with this procedure, four patients (mean age 41.5) with long-standing erectile dysfunction due to veno-occlusive dysfunction, non-responders to phosphodiesterase-5 inhibitors and intracavernous PGE1 injection. RESULTS: Two months post-surgery, intracavernous PGE1 (40 mcg) induced a satisfactory erection in two patients and a 45% and 58% tumescence in the other two. PGE1 responders also responded to 100 mg sildenafil. After 100 mg sildenafil and 20 mg tadalafil, the two non-responders had erections that enabled penetration but were short lasting. CONCLUSION: The procedure described could be more effective than cavernous revascularization operations. The results seem to confirm the mathematical assumptions.

Role of surgery in treatment of locally advanced prostate cancer.

The proportion of prostate cancer diagnosed at localized stages increased from 56.7% to 74. 0% between 1973 and 1993 ("stage migration"). A corresponding increase in the number of radical prostatectomies performed each year was also noted. Nomograms are mathematical algorithms derived from statistical models that are used to predict outcomes for an individual patient, or for groups of patients. In fact, careful pre-operative patient and tumor selection before radical prostatectomy is mandatory. Locally advanced prostate cancer is defined as tumor that has extended clinically beyond the prostatic capsule, with invasion of the pericapsular tissue, apex, bladder neck or seminal vescicle, but without lymph node involvement or distant metastasis. It is estimated that 12-15% of prostate cancer are stage T3. Overstaging or understaging of this cancer is common. Correct staging of clinical T3 disease is even more difficult and both overstaging pT2 and understaging pT4 or pN+ are common. The goals of treatment for T3 tumors are to cure the disease, prolong survival or metastasis-free survival and improve the quality of life. The authors reviewed the most important studies, investigated radical prostatectomy as monotherapy for locally advanced prostate cancer and the integration of surgery with hormonal treatment. The EAU guidelines on prostate cancer state that radical prostatectomy in locally advanced disease is an option for selected patients with small T3, PSA <20 ng/ml, Gleason score <8 and a life expectancy > 10 years. Ten to 15% of clinical T3 are overstaged as pT2. This may lead to the possibility of curing these patients with surgery as the monotherapy. The increased use of nomograms and increased knowledge of recognized prognostic factors could lead to the selection of a large number of patients, often with a long life expectancy, who could benefit from surgical treatment.