Initial experience of transurethral ultrasound ablation of the prostate in Asia.
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ABSTRACT:
SUBMITTER: Miura M
PROVIDER: S-EPMC9579879 | biostudies-literature | 2022 Nov
REPOSITORIES: biostudies-literature
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Initial experience of transurethral ultrasound ablation of the prostate in Asia.
Miura Masayoshi M Takahashi Satoru S Fukumoto Maiko M Higashiyama Hiroshi H
BJUI compass 20220623 6
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Project description:OBJECTIVE:To report on the use of RFA for the treatment of symptomatic benign and autonomously functioning thyroid nodules (AFTNs) in the first reported UK cohort. METHODS:Patients treated over a 19-month period were retrospectively reviewed. Nodules were assessed pre-treatment and at 1 and 6?months post-treatment. Nodule volume was calculated and cosmetic assessment and thyroid-related quality of life (QoL) scores were recorded at each time point. Thyroid function tests (TFTs) were recorded at all three time points for patients with ATFNs. RESULTS:46 patients with 50 nodules were treated with no complications. The mean volume reduction 1-month post-treatment was 53 +- 14.9 % ( p < 0.0001). Six month data was available for 31 nodules and showed a mean 67 +- 17.6%?vol reduction ( p < 0.0001). Five of the six patients with ATFNs were euthyroid at 1-month post-procedure. 6-month data was available on three of these patients, and all remained euthyroid. The thyroid-related QoL and cosmetic scores also improved. Data from 23 patients was available pre-treatment and at 6?months post-treatment and there was a significant ( p < 0.0001) reduction in QoL score. Pre-treatment, 82 % of nodules were readily visible at rest, decreasing to 12.5 % 6 months after treatment ( p < 0.0001). CONCLUSIONS:Results align with published data suggesting that RFA is effective at reducing nodule volume and at treating ATFNs and leads to improvement in thyroid-related QoL and cosmetic scores. ADVANCES IN KNOWLEDGE:This early UK experience demonstrates that day-case radiofrequency ablation can provide safe and effective treatment of benign symptomatic thyroid nodules.
| S-EPMC6592080 | biostudies-literature
Project description:BackgroundUp to half of all men who undergo primary radiotherapy for localized prostate cancer (PCa) experience local recurrence.ObjectiveTo evaluate the safety and early functional and oncological outcomes of salvage magnetic resonance imaging-guided transurethral ultrasound ablation (sTULSA) for men with localized radiorecurrent PCa.Design setting and participantsThis prospective, single-center phase 1 study (NCT03350529) enrolled men with biopsy-proven localized PCa recurrence after radiotherapy. Multiparametric magnetic resonance imaging (mpMRI) and 18F prostate-specific membrane antigen-1007 (18F PSMA-1007) positron emission tomography (PET)-computed tomography (CT) were used to confirm organ-confined disease localization. Patients underwent either whole-gland or partial sTULSA, depending on their individual tumor characteristics.Outcome measurements and statistical analysisPatients were followed at 3-mo intervals. Adverse events (AEs, Clavien-Dindo scale), functional status questionnaires (Expanded Prostate Cancer Index [EPIC]-26, International Prostate Symptom Score, International Index of Erectile Function-5), uroflowmetry, and prostate-specific antigen (PSA) were assessed at every visit. Disease control was assessed at 1 yr using mpMRI and 18F-PSMA-1007 PET-CT, followed by prostate biopsies.Results and limitationsEleven patients (median age 69 yr, interquartile range [IQR] 68-74) underwent sTULSA (3 whole-gland, 8 partial sTULSA) and have completed 12-mo follow-up. Median PSA was 7.6 ng/ml (IQR 4.9-10) and the median time from initial PCa diagnosis to sTULSA was 11 yr (IQR 9.5-13). One grade 3 and three grade 2 AEs were reported, related to urinary retention and infection. Patients reported a modest degradation in functional status, most significantly a 20% decline in the EPIC-26 irritative/obstructive domain at 12 mo. A decline in maximum flow rate (24%) was also observed. At 1 yr, 10/11 patients were free of any PCa in the targeted ablation zone, with two out-of-field recurrences. Limitations include the nonrandomized design, limited sample size, and short-term oncological outcomes.ConclusionssTULSA appears to be safe and feasible for ablation of radiorecurrent PCa, offering encouraging preliminary oncological control.Patient summaryWe present safety and 1-yr functional and oncological outcomes of magnetic resonance imaging-guided transurethral ultrasound ablation (TULSA) as a salvage treatment for local prostate cancer recurrence after primary radiation. Salvage TULSA is safe and shows the ability to effectively ablate prostate cancer recurrence, with acceptable toxicity.
| S-EPMC8317885 | biostudies-literature
Project description:The treatment of low-risk prostate cancer is a common clinical dilemma between standard curative whole gland therapy (and its associated quality of life diminishing side effects) and active surveillance (and its low, but real, risk of progression). The goal of focal therapy in low-risk prostate cancer is to achieve the best balance between cancer control and maintenance of quality of life. Magnetic resonance-guided focused ultrasound (MRgFUS) surgery is a non-invasive thermal ablation method that integrates magnetic resonance imaging for target identification, treatment planning and closed-loop control of thermal deposition and focused ultrasound for thermal ablation of the tumour target. This novel transrectal system allows for tumour localization, targeting and monitoring of tumour target ablation in real time, while simultaneously preserving adjacent normal tissue thereby minimizing the side effects of standard curative surgical or radiation therapy. We report the first North American clinical experience of treatment of localized prostate cancer with focal MR-guided transrectal focused ultrasound (clinicaltrial.gov identifier NCT01226576).
| S-EPMC3529739 | biostudies-literature
Project description:Focal therapy of prostate cancer is an evolving treatment strategy that destroys a predefined region of the prostate gland that harbors clinically significant disease. Although long-term oncologic control has yet to be demonstrated, focal therapy is associated with a marked decrease in treatment-related morbidity. Focal laser ablation is an emerging modality that has several advantages, most notably real-time magnetic resonance imaging (MRI) compatibility. This review presents the principles of laser ablation, the role of multiparametric MRI for delineating the site of significant prostate cancer, a summary of published clinical studies, and our initial experience with 23 patients, criteria for selecting candidates for focal prostate ablation, and speculation regarding future directions.
| S-EPMC4080850 | biostudies-literature
Project description:ObjectivesTo assess differences in 24-month oncologic and functional outcomes in men with low to intermediate-risk prostate cancer treated with MRI-guided transurethral ultrasound ablation (TULSA) using intentionally conservative versus intensified treatment parameters.Patients and methodsPatients from a single center involved in two multicenter trials were included in this analysis. This included 14 of 30 patients with Gleason 3 + 3 from a Phase I study using intentionally conservative treatment parameters, and 15 of 115 patients with Gleason ≤ 3 + 4 from a pivotal study using intensified parameters. Follow-up data compared across these cohorts included 12-month biopsy and MRI for all patients, and 24-month PSA, micturition and quality of life (IIEF, IPSS, IPSS-QOL). The prognostic value of baseline parameters and PSA kinetics on 12-month histological recurrence was evaluated by logistic regression.Results12-month biopsy revealed clinically significant residual disease in 4 (29%) and 2 (14%) patients from the Phase I and pivotal studies, respectively. PSA nadir was 0.7 ng/ml for Phase I and 0.5 ng/ml for pivotal study patients. Patient age at diagnosis, use of MRI fusion/systematic prostate biopsy, number of obtained cores at initial biopsy, PSA course, and PSA nadir were identified as prognostic factors for treatment success. All but one patient from each cohort maintained erection firmness sufficient for penetration. No cases of pad use were reported at 24 months. There were no Grade 4 or higher adverse events, and no late toxicity related to the procedure.ConclusionTwo-year follow-up demonstrated the efficacy of TULSA for the treatment of localized prostate cancer, and the durability of PSA and functional outcomes. Intensifying treatment parameters in the pivotal trial had no impact on safety or functional outcomes through 24 months, while reducing the recurrence rate for clinically significant disease. Careful patient selection by MRI fusion/systematic prostate biopsy and adequate follow-up through routine 12-month biopsy are recommended.
| S-EPMC8579125 | biostudies-literature
Project description:BackgroundWe aimed to conduct a systematic review and meta-analysis of studies reporting functional and oncologic outcomes of combining whole-gland high-intensity focused ultrasound ablation (HIFU) with transurethral resection of the prostate (TURP) in prostate cancer (PCa) patients.MethodsPubMed, Embase, Web of Science, Scopus, and Cochrane Library were systematically searched until June 30, 2022. The ROBINS-I tool scale was used to evaluate quality of eligible studies. Biochemical failure was defined according to the criteria used in each raw study. The presence of any cancer on follow-up biopsy was classified as "positive biopsy". Patients able to penetrate their partner without pharmacologic support were rated potent. Meta-analysis was performed to evaluate functional outcomes using R project.ResultsA total of 1861 patients in 15 eligible studies were included. All studies were identified as moderate or high quality. There were 1388 (74.6%) patients with low-risk or intermediate-risk PCa in 15 studies and 473 (25.4%) patients with high-risk PCa in 12 studies. The mean PSA nadir postoperatively ranged from 0.20 to 1.90 ng/mL within average time of 1.9-12 months. Biochemical failure rates in all 15 studies ranged from 6.3% to 34% within average time of 1.9-60 months. Eleven studies reported the rates of positive biopsy ranged from 3% to 29.7% within average time of 3-12 months postoperatively. Based on the results of single-arm meta-analysis, the pooled rates of any degree urinary incontinence, acute urinary retention, urinary tract infections, and urethral stricture were 9.4% (95% CI: 6.1%-12.6%), 0.9% (95% CI: 0%-2%), 2.6% (95% CI: 0.8%-4.3%), and 4.3% (95% CI: 1.4%-7.1%), respectively. The pooled rate of being potent after procedure in previously potent patients was 43.6% (95% CI: 27.3%-59.8%). The sensitivity analysis revealed all the pooled results was relatively reliable. Egger's tests for the pooled results of acute urinary retention (p = 0.0651) and potency (p = 0.6749) both did not show significant publication bias.ConclusionsIt appears that the combination treatment of whole-gland HIFU and TURP could be applied for PCa patients. It might have potential advantages of decreasing catheterization time and improving urinary status. Prospective and comparative studies are needed to validate our findings.
| S-EPMC9597449 | biostudies-literature
Project description:BackgroundCatheter ablation of ventricular tachycardia (VT) can be technically challenging due to difficulty with catheter positioning in the left ventricle (LV) and achieving stable contact. The Hansen Sensei Robotic system (HRS) has been used in atrial fibrillation but its utility in VT is unclear.ObjectiveThe purpose of this study was to test the technical feasibility of robotic catheter ablation of LV ventricular tachycardia (VT) using the HRS.MethodsTwenty-three patients underwent LV VT mapping and ablation with the HRS via a transseptal, transmitral valve approach. Nineteen patients underwent substrate mapping and ablation (18 had ischemic cardiomyopathy, 1 had an apical variant of hypertrophic cardiomyopathy). Four patients had focal VT requiring LV VT mapping and ablation. Procedural endpoints included substrate modification by endocardial scar border ablation and elimination of late potentials, or elimination of inducible focal VT.ResultsMapping and ablation were entirely robotic without requiring manual catheter manipulation in all patients and reaching all LV regions with stable contact. Fluoroscopy time of the LV procedure was 22.2 ± 11.2 minutes. Radiofrequency time was 33 ± 21 minutes. Total procedural times were 231 ± 76 minutes. Complications included a left groin hematoma (opposite to the HRS sheath), 1 pericardial effusion without tamponade that was drained successfully, and transient right ventricular failure in a patient with previous left ventricular assist device. At 13.4 ± 6.7 months of follow-up (range 1-19 months), recurrence of VT occurred in 3 of 23 patients.ConclusionOur initial experience suggests that the HRS allows successful mapping and ablation of LV VT.
| S-EPMC3298677 | biostudies-literature
Project description:IntroductionPulsed field ablation (PFA) was recently introduced for the treatment of symptomatic atrial fibrillation (AF) with the claim of selectively ablating the myocardium while sparing surrounding tissues. We present our initial experience with a PFA catheter for pulmonary vein isolation (PVI) and describe procedural findings and peri-procedural safety of the first 100 patients.Materials and methodsWe investigated 100 patients treated for symptomatic AF using the FARAWAVE PFA catheter (Farapulse, Menlo Park, CA, USA) between July 2021 and March 2022. Procedure workflow and electrophysiological findings at the time of ablation, peri-procedural complications, and operator learning curves are described.ResultsThe mean age of patients was 62.9 ± 9.4 years, 62% were male subjects and 80% had paroxysmal AF. The median CHA2DS2-VASc score was 1.5 (IQR: 1.0-2.0) and the mean left atrial volume index was 35.7 ± 9.6 ml/m2. In 88 (88%) patients, PVI alone was performed and in 12 (12%) patients additional ablation of the posterior wall was performed. 3D-electroanatomic mapping was performed in 18 (18%) patients. Procedures without mapping lasted for 52.3 ± 16.6 min. The mean number of applications per pulmonary vein (PV) was 8.1 ± 0.6. In all patients (100%), all PVs were confirmed to be isolated. The learning curves of the two operators who performed > 20 procedures showed a negligible variation of performance over time and practice did not significantly predict procedure time [Operator 1 (senior): R 2 = 0.034, p = 0.35; Operator 2 (junior): R 2 = 0.004, p = 0.73]. There was no difference between the procedure times between senior and junior operators (Operator 1: 46.9 ± 9.7 min vs. Operator 2: 45.9 ± 9.9 min; p = 0.73). The only complications observed were two cases of bleeding at the site of percutaneous access.ConclusionOur initial experience shows that use of the PFA catheter for pulmonary vein isolation (PVI) is safe, fast, and easy to learn.
| S-EPMC9679623 | biostudies-literature
Project description:PurposeWe evaluated magnetic resonance imaging controlled transurethral ultrasound therapy as a treatment for magnetic resonance imaging defined focal prostate cancer using subsequent prostatectomy and histology as the reference standard.Materials and methodsFive men completed this pilot study, which was approved by the institutional review board. Prior to radical prostatectomy focal tumors identified by magnetic resonance imaging were treated by coagulating targeted subtotal 3-dimensional volumes of prostate tissue using magnetic resonance imaging controlled transurethral focused ultrasound. Treatment was performed with a 3 Tesla clinical magnetic resonance imaging unit combined with modified clinical planning software for high intensity focused ultrasound therapy. After prostatectomy whole mount histological sections parallel to the magnetic resonance imaging treatment planes were used to compare magnetic resonance imaging measurements with thermal damage at the cellular level and, thus, evaluate treatment and target accuracy.ResultsThree-dimensional target volumes of 4 to 20 cc and with radii up to 35 mm from the urethra were treated successfully. Mean ± SD temperature control accuracy at the target boundary was -1.6 ± 4.8C and the mean spatial targeting accuracy achieved was -1.5 ± 2.8 mm. Mean treatment accuracy with respect to histology was -0.4 ± 1.7 mm with all index tumors falling inside the histological outer limit of thermal injury.ConclusionsMagnetic resonance imaging guided transurethral ultrasound therapy is capable of generating thermal coagulation and tumor destruction in targeted 3-dimensional angular sectors out to the prostate capsule for prostate glands up to 70 cc in volume. Ultrasound parameters needed to achieve ablation at the prostate capsule were determined, providing a foundation for future studies.
| S-EPMC5161669 | biostudies-literature
Project description:IntroductionWe aimed to demonstrate feasibility and cancer detection rates of office-based ultrasound-guided transperineal magnetic resonance imaging-ultrasound (MRI-US) fusion (TFB) prostate biopsy under local anesthesia.MethodsWith institutional review board approval, records of men undergoing TFB in the office setting under local anesthesia were reviewed. Baseline patient characteristics, MRI findings, cancer detection rates, and complications were recorded. The PrecisionPoint Transperineal Access System (Perineologic, Cumberland, MD, U.S.), along with UroNav 3.0 image-fusion system (Invivo International, Best, The Netherlands) were used for all procedures. Following biopsy, men were surveyed to assess patient experience.ResultsBetween January 2019 and February 2020, 200 TFBs were performed, of which 141 (71%) were positive for prostate cancer, with 117 (83%) Gleason grade group 2 or higher. A total of 259 of 265 MRI lesions were biopsied, with 127 (49%) positive overall. Prostate Imaging-Reporting and Data System (PI-RADS) 4-5 lesions were positive for prostate cancer in 59% of cases. The mean procedural time was 20 minutes, with a patient enter-to-exit room time of 54 minutes. There were no septic complications, no patients required post-procedure hospital admission, and all procedures were successfully completed. Seventy-five percent of patients surveyed reported complete resolution of pain at three days following the procedure.ConclusionsOffice-based TFB represents a viable approach to prostate cancer detection following prostate MRI. Larger-scale assessment is needed to categorize cancer detection rates more accurately by PI-RADs subset, patient selection factors, complication rate, and cost relative to TFB under anesthesia.
| S-EPMC9328860 | biostudies-literature