Safety and feasibility study of holmium laser enucleation of the prostate (HOLEP) on patients receiving dual antiplatelet therapy (DAPT)

To report 5-year follow-up results of a randomised clinical trial comparing holmium laser enucleation of the prostate (HoLEP) with open prostatectomy (OP). One hundred twenty patients with prostates greater than 100g in weight according to transrectal ultrasound were randomised to either the HoLEP or the OP group (ie, 60 patients to each group). Preoperative and postoperative assessments included American Urological Association Symptom Score (AUA-SS), maximum urinary flow rates (Qmax), and postvoid residual urine (PVRU) volumes. Measurements were performed at 1, 3, 6, 12, 18, 24, 36, 48, and 60 mo. Postoperative outcome data were compared. All complications were recorded. Five years postoperatively, a total of 46 patients (38.3%) were lost to follow-up or had to be excluded from the study. All the remaining 74 patients (42 HoLEP vs. 32 OP patients, p=0.11) had undergone the 5-yr follow-up assessments. Mean AUA-SS was 3.0 in both groups (p=0.98), mean Qmax was 24.4 ml/s in both groups (p=0.97) and PVRU volume was 11 ml in the HoLEP and 5 ml in the OP group (p=0.25). Late complications consisted of urethral strictures and bladder-neck contractures; reoperation rates were 5% in the HoLEP and 6.7% in the OP group (p=1.0). No patient developed benign prostatic hyperplasia recurrence. Five years after the operation, the improvements in micturition obtained with HoLEP and OP were equally good, and reoperation rates similarly low. HoLEP seems to be a true endourological alternative to OP.

To assess the durability of holmium laser enucleation of prostate in comparison to transurethral resection of the prostate (TURP). Patients were enrolled in the present study between June 1997 and December 2000 and followed per protocol. All patients were urodynamically obstructed with a prostate volume of between 40 and 200 mL. At long-term follow-up, variables assessed included Benign Prostatic Hyperplasia Impact Index (BPHII), International Continence Society Short Form Male questionnaire (ICSmale-SF) and the International Index of Erectile Function (IIEF). Adverse events, including the need for retreatment, were specifically assessed. Thirty-one (14 holmium laser enucleation of the prostate [HoLEP] and 17 TURP) of the initial 61 patients were available, with 12 deceased and 18 lost to follow-up. The mean (range) follow-up was 7.6 (5.9-10.0) years and the mean (±sd) age at follow-up was 79.8 (±6.2) years. The mean (±sd) values (HoLEP vs TURP) were as follows: maximum urinary flow rate (Q(max)), 22.09 ± 15.47 vs 17.83 ± 8.61 mL/s; American Urological Association (AUA) symptom score, 8.0 ± 5.2 vs 10.3 ± 7.42; quality of life (QOL) score 1.47 ± 1.31 vs 1.31 ± 0.85; BPHII, 1.53 ± 2.9 vs 0.58 ± 0.79; IIEF-EF (erectile function), 11.6 ± 7.46 vs 9.21 ± 7.17; ICSmale Voiding Score (VS), 4.2 ± 3.76 vs 3.0 ± 2.41; ICSmale Incontinence Score (IS), 3.07 ± 3.3 vs 1.17 ± 1.4. There were no significant differences in any variable between the two groups beyond the first year. Of the assessable patients, none required re-operation for recurrent BPH in the HoLEP arm and three (of 17) required re-operation in the TURP arm . The results of this randomized trial confirm that HoLEP is at least equivalent to TURP in the long term with fewer re-operations being necessary. © 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.

The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.