Percutaneous transluminal angioplasty versus primary stenting in infrapopliteal arteries in critical limb ischemia.

BACKGROUND: In endovascular recanalisation of infrapopliteal arteries, studies have already pointed out the value of balloon angioplasty, but for stent implantation very few randomized controlled data exist so far. PATIENTS AND METHODS: We conducted a randomized controlled prospective trial in patients with critical limb ischemia (CLI) comparing the effect of percutaneous transluminal balloon angioplasty (PTA) versus primary stenting in infrapopliteal arteries, concerning 1-year clinical benefit and reobstruction rate. RESULTS: 54 patients were either randomized for primary stenting (balloon expandable stent) or PTA alone, 33 patients were assigned to the PTA group, 21 patients to the stent group. The whole follow up period of 12 months was completed by 46 patients. Improvement by at least one Rutherford classification was reached by a total of 33 (75.0 %) of patients at month 12, 22 (81.5 %) in the PTA group and 11 (64.7 %) in the stent group. A complete ulcer healing at month 12 showed 21 (63.6 %) of all patients, with a higher percentage in patients treated with PTA alone 16 (80.0 %) vs 5 (38.5 %). 50.0 % of all patients showed re-obstruction over the follow-up period, 39.4 % of the PTA and 66.7 % of the stent group. At month 3 primary patency rate was nearly equal in both groups (76.7 % PTA vs 75.0 % stent), but drifted apart with the duration of the follow-up period, with a primary patency at month 12 in the PTA group of 48,1 % vs 35,3 % in the stent group. As for secondary patency at month 12 the PTA group showed a patency rate of 70.4 %, vs 52.9 % in the stent group. CONCLUSIONS: Primary stenting with balloon expandable stents in the infrapopliteal arteries does not outway the benefit of PTA alone with the application of modern hydrophilic balloon catheters in patients with CLI.

[Percutaneous radio-frequency ablation (PRFA) in painful metastases involving bone]. / Die perkutane Radiofrequenzablation (PRFA) bei symptomatischen sekundär-neoplastischen Knochenläsionen.

AIM: The aim of the study was to determine the efficacy of PRFA in the palliative treatment of symptomatic bone metastases in regard to pain reduction, safety, and quality of life. METHOD: Over a period of 11 months, ten PRFA were performed in eight patients with painful metastases involving bone, where conventional treatment with radiation therapy, chemotherapy, and treatment with analgesics had failed to reduce the pain efficiently. Pain was measured with the visual analogue scale (VAS: 0 to 10) for the day and night before PRFA was performed, and daily for 7 days after release from the hospital via a dietary book, and at the follow-up periods of 1, 3, 6 weeks and 3 and 6 months after PRFA. Additionally, quality of life was self-assessed by the patient via the health surveys IQOLA SF-36 and EORTC QLQ-C30, and via the Karnofsky Performance Scale (KPS) by the physician at each follow-up. The patients' analgesics use was also recorded at the follow-up intervals and complications were monitored. Analysis of the primary end point was undertaken with paired comparison procedures. RESULTS: Under conventional therapy, pain was specified by the patients as VAS min of 4.1 and VAS max of 9.3. Due to PRFA a reduction of the preinterventional pain (VAS) from 7.4 (+/- 1.9 SD) and 5.0 (+/- 2.7 SD) for day and night, subsequently, to 1.8 (+/- 1.6 SD, minus 75 percent) and 0.7 (+/- 0.7 SD, minus 86 percent) was achieved within one day after admission to the hospital. This significant reduction did not change during the whole follow-up period, and was also reflected in the ability to reduce analgesics and in the improvement of specific domains of SF-36 and QLQ-C30. However, no significant change was detected in the summary scales for mental and physical health. No serious complications were observed. CONCLUSION: PRFA of symptomatic bone metastases is a safe technology to reduce pain intractable to conventional therapy, even in terminally ill patients.