Comparison of immediate and follow-up results of the short and long NIR stent with the Palmaz-Schatz stent.

The intrinsic characteristics of a stent including stent length may affect both procedural success and long-term outcome. The present study evaluated the immediate and follow-up results after implantation of the short and long NIR stent and compared these results with the Palmaz-Schatz stent. Between July 1995 and December 1996, stenting with a 16-mm NIR stent (NIR-16), a 32-mm NIR stent (NIR-32), or a Palmaz-Schatz stent (PS) was performed in 68, 57, and 155 lesions, respectively. There were no significant differences in the incidences of delivery failure (PS, 2.6%: NIR-16, 4.4%; NIR-32, 5.3%; p = NS) and procedural success (PS, 92%; NIR-16, 93%; NIR-32, 93%; p = NS) among the 3 groups. The reference vessel diameter was smaller in lesions with a 32-mm NIR stent than in those with a Palmaz-Schatz stent (PS, 3.14+/-0.58, NIR-16, 3.00+/-0.50; NIR-32, 2.90+/-0.47 mm; p <0.05). The lesion length was longer in lesions with a 32-mm NIR stent than in those with a Palmaz-Schatz or a 16-mm NIR stent (PS, 8.9+/-5.0; NIR-16, 11.0+/-4.1; NIR-32, 26.1+/-9.7 mm; p <0.01). After the procedure, the lesions with a 32-mm NIR stent had a smaller minimal lumen diameter than those with a Palmaz-Schatz stent (PS, 3.17+/-0.61; NIR-16, 2.99+/-0.51; NIR-32, 2.89+/-0.49 mm; p <0.01). At follow-up, a smaller minimal lumen diameter was observed in lesions with a 32-mm NIR stent than in those with a Palmaz-Schatz or a 16-mm NIR stent (PS, 2.32+/-0.98; NIR-16, 2.25+/-0.80; NIR-32, 1.68+/-0.79 mm; p <0.01). Restenosis rates were 16.5% in lesions with a Palmaz-Schatz stent, 13.3% in those with a 16-mm NIR stent, and 47.4% in those with a 32-mm NIR stent (p <0.01). Although stent delivery and procedural success of a long NIR stent were acceptable, the restenosis rate of a long NIR stent was high compared with a short NIR stent or a Palmaz-Schatz stent.     

Endovascular repair of carotid artery aneurysm with Jostent covered stent: initial experience and one-year result.

Treatment for symptomatic extracranial carotid artery aneurysm is evolving and we describe two cases of successful endovascular treatment of distal internal carotid aneurysm using Jostent, a balloon-expandable coronary polytetrafluoroethylene-covered stent. Both patients remained symptom-free at 1 year after the procedure and patency of the stents was maintained. We conclude that endovascular treatment of carotid artery aneurysm with Jostent is feasible and safe and may be more preferable than conventional strategies.     

Subacute stent thrombosis associated with a heparin-coated stent and heparin-induced thrombocytopenia.

Subacute stent thrombosis occurred in a patient 34 days after receiving a heparin-coated (HC) stent. The patient developed heparin-induced thrombocytopenia and diffuse thrombosis after the stent was placed. This raises the concern that patients who develop heparin-associated antibodies in the context of a recently placed HC stent may have an increased risk for subacute stent thrombosis.     

Results of the Jostent coronary stent graft implantation in various clinical settings: procedural and follow-up results.

The Jostent coronary stent graft (CSG) is composed of a PTFE layer sandwiched between two stainless steel stents, initially introduced for the treatment of coronary perforations and aneurysms with excellent results. By providing a mechanical barrier, this stent design also may be beneficial in the treatment of complex ulcerated lesions and in-stent restenosis by preventing debris protrusion and neointimal proliferation through the stent struts. To evaluate the safety and efficacy of this stent graft, we implanted 78 CSGs in 70 patients for a broad range of indications, including coronary perforations, aneurysms, degenerated saphenous vein grafts, complex lesions, and in-stent restenosis. The primary angiographic success rate (95.9%) was high, and using intravascular ultrasound (IVUS) guidance during stent implantation and high inflation pressures (19.3 +/- 3.2 atm), stent expansion with optimal symmetry was achieved in 94.7%. One limitation of the Jostent CSG was the side-branch occlusion rate (18.6%) and the resulting non-Q-wave infarction rate in seven cases (mean CK elevation, 238 U/l), acute Q-wave MI in two cases, and transient ventricular fibrillation in one patient after occlusion of the proximal RCA side branch without further complications. Subacute stent thrombosis occurred in four cases (5.7%) 7 to 70 days after stent implantation, despite using combined antiplatelet therapy with aspirin (ASA), ticlopidine, and/or clopidogrel for 30 days. Angiographic follow-up was available in 56 patients (80.0%) after a mean of 159 +/- 49 days, and follow-up IVUS was available in 38 cases. The overall restenosis rate (> 50% diameter stenosis) was 31.6% manifest primarily as edge restenosis (29.8% stent edge vs. 8.8% stent center; P < 0.001). IVUS examinations showed a minimal late lumen loss of 0.4 +/- 2.2 mm(2) within the center of the stent graft vs. 3.2 +/- 2.3 mm(2) at the stent edges (P < 0.001). The restenosis rate in the prespecified subgroups was 33.3% for saphenous vein grafts (2/6 lesions), 30.0% in complex lesions (6/20 lesions), and 38.5% (10/26 lesions) for the treatment of in-stent restenosis. Implantation of the Jostent CSG is feasible and safe, even in complex lesion subsets, and is associated with high primary success rates provided major side branches are avoided. The use of this stent may require an extended time course of antiplatelet therapy. Frequent focal stent edge renarrowing influences the overall restenosis rate. However, in treatment of complex in-stent restenosis and vein graft lesions, stent grafts may offer benefit over conventional therapies. Covered stents such as the JoMed coronary stent graft may become essential for bailout treatment of coronary perforations.     

Clinical and angiographic outcome of stent implantation without predilatation using the Jostent Flex stent

Conventional stenting requires predilatation which potentially increases vessel wall injury and cost of the procedure. In this study, the safety and efficacy of direct Jostent Flex (Jomed AB, Helsingborg, Sweden) stent placement was evaluated in 50 patients. Quantitative coronary angiography was performed at baseline, post-stent and 6 months follow-up. Clinical follow-up was done up to 9 months. In 50 patients (38 male/12 female; age 61+/-12 years) with stable (n = 42; 84%) or unstable (n = 8; 16%) angina, 53 Jostent Flex (JF) stents (diameter 3.2+/-0.2 mm) were implanted for 51 stenoses. Direct stenting was successful in 46 stenoses (90%). No stents were lost or damaged when retrieved after unsuccessful direct delivery. Eventually, all stents could be implanted at the target site. Angiographic success (<30% residual stenosis) was achieved in 49 lesions (96%). At 9 months, none of the patients had died. Target lesion revascularization was necessary in 4 (8%) patients at 6 months and in 2 (4%) other patients between 6 and 9 months. Minimal lumen diameter increased from 1.1+/-0.4 to 2.6+/-0.4 mm (p<0.001) after stent placement and 1.8+/-0.6 mm (p<0.001) at 6 months follow-up. Angiographic restenosis (> 50%) at 6 months was present in 24% of 49 treated stenoses. At 6 and 9 months, 39 (78%) and 41 (82%) of the patients were free of anginal symptoms and the ischemic event-free survival was 80% at 9 months. This study demonstrates the safety and efficacy of direct placement of the JF stent as well as favorable clinical and angiographic results up to 9 months after the procedure.     

Coronary intervention with a heparin-coated stent and aspirin only

OBJECTIVES: To determine the safety and efficacy of a post-stenting anti-platelet regimen of aspirin without additional ticlopidine or clopidogrel after successful heparin-coated stent implantation. METHODS: A prospective, non-randomized, multi-center pilot study of patients undergoing percutaneous coronary intervention, including those with acute coronary syndromes and small vessels with one-month clinical follow-up, was undertaken. Patients received a heparin-coated stent and were treated with aspirin only. RESULTS: Over a period of 6 months, a total of 122 patients were recruited in 6 centers. Their mean age was 57.2 10.0 years, 79% were male and 31% had unstable angina. Most (75%) had single-vessel disease, predominantly of the left anterior descending artery (51%), with a mean reference diameter of 2.44 mm 0.44 mm at baseline and 2.48 0.41 mm post stenting. At a 1-month clinical follow-up, no major adverse cardiovascular events (including subacute stent thrombosis) had occurred. Five patients were readmitted to hospital for symptoms unrelated to the interventional procedure. CONCLUSIONS: Heparin-coated stent implantation using an antiplatelet regimen of aspirin only, appears to be safe and feasible. A randomized trial of a larger number of patients appears warranted.     

国产Willis覆膜支架治疗复杂性颅内动脉瘤的疗效及长期随访

目的评价国产Willis覆膜支架系统治疗复杂性颅内动脉瘤患者的安全性及远期疗效。方法 2006年10月—2007年9月,复旦大学附属华山医院神经外科单纯采用国产颅内Willis覆膜支架系统,治疗7例复杂性颅内动脉瘤,其中颈内动脉海绵窦段3例,颈内动脉眼动脉段1例,4例均为大型宽颈动脉瘤;颈内动脉后交通段复发动脉瘤1例,椎动脉小脑后下动脉下段大型夹层动脉瘤2例。结果①对7例（7个动脉瘤）患者共置入9枚覆膜支架,其中8枚成功置入载瘤动脉。对5例置入支架后即刻造影,显示病变完全消失,载瘤动脉通畅;1例巨大海绵窦段动脉瘤置入1枚支架后,有少量对比剂漏入动脉瘤（内漏）;1例椎动脉瘤置入第1枚支架内漏明显,再置入1枚支架后好转。②术中发生颅内远端血管破裂出血1例,经开颅手术清除血肿后痊愈。其他病例无手术相关并发症。③术后5～12个月对7例患者均行临床及DSA随访,均无神经功能障碍。2例有内漏者,1例消失,1例仍有少量内漏,但较术后即刻明显好转;7例均无动脉瘤复发,载瘤动脉通畅。5例术后45～55个月再获得DSA随访,动脉瘤无复发,载瘤动脉通畅、无狭窄。1例失访,1例非动脉瘤性死亡。结论对部分复杂性颅内动脉瘤,采用Willis覆膜支架治疗安全有效,长期疗效较好。     

Long-term clinical safety and efficacy of NIROYAL vs. NIR intracoronary stent.

Research in vitro and in animal models suggested that gold electroplating of stents can attenuate neointimal hyperplasia and reduce thrombogenicity. The objective of this study was to evaluate the safety and efficacy of the gold-coated NIROYAL stent in the treatment of stenosed coronary arteries and bypass grafts. We retrospectively studied 181 consecutive patients undergoing deployment of NIR (n = 87) or NIROYAL (n = 94) coronary stents in a single tertiary referral center from July 1997 to December 1998. Mean follow-up duration for the NIR and NIROYAL patient groups were 11.6 and 11.4 (range, 3-12) months, respectively. Stent thrombosis rates were 3/87 (3%) in the NIR and 0/94 (0%) in the NIROYAL group (P = 0.07). The need for target lesion revascularization (TLR) in the NIR patient group was 8/87 (9%) compared to 11/94 (12%) in the NIROYAL patient group (P = 0.6). The overall MACE rates for the NIR and NIROYAL patient groups were 24/87 (28%) and 22/94 (23%), respectively (P = 0.5). The present study, hence, implies equivalence between the stainless steel NIR and the gold-plated NIROYAL stent with no significant difference in immediate and long-term clinical performance profiles.     

Long-term follow-up after angiographically successful coronary stenting: direct stent versus conventional stent implantation

The purpose of the study was to compare the impacts of angiographically successful direct stent implantation and conventional stent implantation (stent implantation following predilatation) on long-term major cardiac events. The authors prospectively studied 40 patients who had successful direct stent implantation and 46 patients who had successful conventional stent implantation. The end-point of the study was defined as the occurrence of a major cardiac event, including recurrent angina, acute myocardial infarction, death, and target vessel revascularization. The demographic and clinical characteristics of the study groups were similar, except the indication of percutaneous angioplasty, which was more frequently unstable angina in the conventional stent group (63% vs 38%, P: 0.03). Procedural minor complications were more frequent in conventional stent implantation, and there was also a positive correlation between the conventional stent implantation and procedural minor complications (r = 0.231, P: 0.03), and postprocedural troponin elevation (r = 0.221, P: 0.04). The incidences of major cardiac events including recurrent angina, acute myocardial infarction, death, death or myocardial infarction, and target vessel revascularization were not different between the study groups during the long-term follow-up period (21 +/- 7.1 months for direct stent group and 20 +/- 7.5 months for conventional stent group). Overall end-points occurred in 9 patients (22%) in the direct stent group and in 9 patients (19%) in the conventional stent group. Kaplan-Meier survival analysis showed that there was no difference in event-free survival between the patients treated with direct stent implantation and conventional stent implantation (log-rank: 1.52, P = 0.21). Two-vessel intervention and hypertension were found to be related with long-term major cardiac events (r = 0.214, P: 0.048, r = 0.206, P: 0.04, respectively). In addition to the procedural advantages, direct stent implantation may also provide comparable results with conventional stent implantation concerning the late cardiac events following successful percutaneous coronary angioplasty.     

Preliminary experience with the NIR coronary stent

We prospectively studied 223 patients (288 lesions) who underwent elective or bail out implantation of 309 NIR stents (Scimed, Boston Scientific Corporation, Galway, Ireland). Most lesions (68.4%) had unfavorable characteristics (type B2 or C). Primary success in stent deployment was achieved in 305 (98.6%). There was no Q-wave myocardial infarction. Emergency coronary artery bypass grafting (CABG) was required in 1 patient and 1 death occurred. Subacute thrombosis rate was 0.4%. Reference diameter was 2.65 ± 0.67 mm. Minimum luminal diameter (MLD) increased from 0.62 ± 0.45 to 2.69 ± 0.57 mm and diameter stenosis decreased from 78.3 ± 13.4% to 12.7 ± 5.9%. Clinical follow-up was performed in the first 135 patients for 5.3 ± 1.6 months and repeat angiography was undertaken in 35 (16%) with recurrence of symptoms at 4.6 ± 1.3 months. Clinical restenosis rate was 9.6%. We conclude that the NIR coronary stent exhibits favorable performance characteristics and appears to be safe and efficacious in the treatment of coronary lesions even in the presence of high-risk characteristics. Cathet. Cardiovasc. Diagn. 43:153–158, 1998. © 1998 Wiley-Liss, Inc.     

Clinical experience with the NIR stent: Retrospective observation on acute results and follow-up in 709 patients

The NIR stent is an expandable cellular coronary prosthesis with high flexibility and excellent trackability. the very low crossing profile, associated to the high flexibility, makes this stent suitable for complex and distal lesions. The aim of this study was to evaluate the feasibility, safety, and long-term (clinical follow-up) efficacy of elective and/or urgent deployment of the NIR stent in a broad patient group with coronary artery disease. Between June 1996 and May 1997, 986 NIR stents were implanted in 781 vessels (de novo or restenotic lesions in native vessels, saphenous vein grafts and internal mammary conduits) of 709 consecutive patients (498 men, 211 women) undergoing coronary angioplasty in two Villa Maria Group Catheterization Laboratories. Procedural angiographic success was achieved in 98.4% of all the lesions treated, ranging from 100% success rate in type A lesion to 97.6% in type C lesions (overall procedural success, 98.4%). Major adverse cardiac events (MACE) were considered from PTCA/stenting time to the patient discharge. The in-hospital MACE were limited and occurred in 15 patients: urgent surgical revascularization 0.8%, death 0.7%, sub-acute stent thrombosis 0.5% (overall in-hospital MACE rate 2.1%). Clinical follow-up data were obtained at 8.6±2.8 months following the stenting procedure. The event-free survival rate was 87.9%. The late MACE rate evaluation showed death, target lesion revascularization 9.9% (over-all late MACE rate 12.1%). The NIR stent performances in this broad patient population were excellent, showing very high procedural success rate both in normal and complex coronary anatomy. On the basis of the previous data, we can define NIR stent a safe multifunctional device suitable both for easy and complex situations. The clinical late results are very promising in term of event-free survivals and late MACE.     

Frequency of and risk factors for stent thrombosis after drug-eluting stent implantation during long-term follow-up

Despite concerns regarding the long-term safety of drug-eluting stent (DES) implantation because of late-onset stent thrombosis, the actual incidence of stent thrombosis after 1 year is unknown. We investigated the incidence, risk factors, and association of antiplatelet therapy interruption for the development of stent thrombosis after DES implantation during long-term follow-up. A total of 1,911 consecutive patients with DES implantation were enrolled (sirolimus-eluting stents in 1,545 patients, 2,045 lesions; paclitaxel-eluting stents in 366 patients, 563 lesions). During long-term follow-up (median 19.4 months, interquartile range 15.3 to 24.3), 15 patients (0.8%, 95% confidence interval 0.5% to 1.3%) developed stent thrombosis within 6 hours to 20.4 months. Eleven patients (0.6%, 95% confidence interval 0.3% to 1.0%) had late thrombosis (median 6.1 months). The incidence of stent thrombosis was 3.3% (4 of 121 patients) in patients with complete interruption of antiplatelet therapy (vs 0.6% in those without, p = 0.004) and 7.8% (5 of 64 patients) with premature interruption of aspirin or clopidogrel, or both (vs 0.5% in those without, p < 0.001). Independent predictors of stent thrombosis were premature antiplatelet therapy interruption, primary stenting in acute myocardial infarction, and total stent length. Stent thrombosis also developed while patients were on dual antiplatelet therapy (all patients with acute/subacute stent thrombosis and 36% of those with late stent thrombosis; 47% of total with stent thrombosis). In conclusion, stent thrombosis occurred in 0.8% after DES implantation during long-term follow-up. The incidence of late stent thrombosis was 0.6%, similar to that for bare metal stents. The predictors of stent thrombosis were premature antiplatelet therapy interruption, primary stenting in acute myocardial infarction, and total stent length.     

Comparison of direct stenting with conventional stent implantation in acute myocardial infarction

Small studies have suggested that direct stenting without balloon predilatation in ST-segment elevation myocardial infarction may reduce microcirculatory dysfunction. To examine the clinical benefits of direct stenting in a large cohort of patients who underwent primary percutaneous coronary intervention treated with contemporary pharmacotherapy, the 1-year outcomes from the multicenter, randomized Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial were analyzed. A total of 3,602 patients with ST-segment elevation myocardial infarction who underwent primary percutaneous coronary intervention were enrolled. The present study cohort consisted of 2,528 patients in whom single lesions (excluding bypass grafts) were treated with stent implantation. At operator discretion, direct stenting was attempted in 698 patients (27.6%), and stenting was performed after predilatation in 1,830 patients (72.4%). Propensity-score matching was performed to reduce bias. Direct stenting was successful in 677 patients (97.0%). ST-segment resolution at 60 minutes after the procedure was improved in patients who underwent direct compared to conventional stenting (median 74.8% vs 68.9%, respectively, p = 0.01). At 1-year follow-up, direct compared to conventional stenting was associated with a significantly lower rate of all-cause death (1.6% vs 3.8%, p = 0.01) and stroke (0.3% vs 1.1%, p = 0.049), with nonsignificant differences in target lesion revascularization, myocardial infarction, stent thrombosis, and major bleeding. Death at 1 year remained significantly lower in the direct stenting group after multivariate adjustment (hazard ratio 0.42, 95% confidence interval 0.21 to 0.86, p = 0.02) and in a propensity score-based analysis (hazard ratio 0.92, 95% confidence interval 0.88 to 0.95, p = 0.02). In conclusion, compared to stent implantation after predilatation, direct stenting is safe and effective in appropriately selected lesions in patients with ST-segment elevation myocardial infarction who undergo primary percutaneous coronary intervention and may result in improved survival.     

Comparison with conventional therapies of repeated sirolimus-eluting stent implantation for the treatment of drug-eluting coronary stent restenosis

This study compared the safety and efficacy of repeat percutaneous coronary intervention (PCI) using sirolimus-eluting stents (SESs) with conventional therapies for restenosis after drug-eluting stent placement. Fifty-five consecutive patients with 58 restenotic lesions (31 treated with SESs and 27 treated with paclitaxel-eluting stents) underwent PCI using SESs (33 lesions) or conventional therapies comprising cutting balloon angioplasty alone (11 lesions) or intracoronary brachytherapy (14 lesions). Baseline characteristics were similar for the 2 groups, except for greater edge involvement (75.8% vs 36.0%, p = 0.002) and less stent expansion (0.74 +/- 0.17 vs 0.95 +/- 0.21, p = 0.006) in the SES group than in the conventional group. The SES group achieved a greater postprocedural luminal gain than the conventional group (1.98 +/- 0.50 vs 1.22 +/- 0.48 mm, p <0.001). Follow-up angiography showed that late luminal loss (0.27 +/- 0.56 vs 0.76 +/- 0.84 mm, p = 0.021) and recurrent angiographic restenosis rate (3.6% vs 35.0%, p = 0.006) were lower in the SES group than in the conventional group. The repeated target lesion revascularization-free survival rates at 1 year were 96.7 +/- 3.2% for the SES group and 91.7 +/- 5.6% for the conventional group (p = 0.399). In conclusion, use of SESs was associated with a lower recurrent restenosis rate compared with conventional therapies.     

国产Firebird支架的远期安全性和有效性研究

目的 观察国产Firebird西罗莫司涂层支架治疗冠心病的远期安全性和治疗效果.方法 465例接受介入治疗的冠心病患者,由患者自主选择应用国产Firebird支架或进口Cypher支架,随访观察可能的不良事件和治疗效果,随访时间不少于24个月. 结果 Firebird组321例,随访观察(45.3±11.1)个月,其中166例(51.7%)复查冠状动脉造影,Cypher组144例,随访观察(46.1±12.1)个月,其中82例(56.3%)复查冠状动脉造影.随访结束时,两组间全因死亡(7.8%和7.6%)(x2=1.32,P=0.250)、心源性死亡(5.9%和5.6%)(x2=0.02,P=0.877)、急性心肌梗死(2.8%和3.4%)(x2=0.15,P=0.697)、因心血管事件再入院率(29.6%和31.9%)(x2=0.26,P=0.610)、急性和亚急性血栓事件(0.9%和1.3%)(x2=0.19,P=0.661)、晚期血栓事件(L 2%和1.3%)(x2=0.02,P=0.900)、靶病变再次血运重建术(3.4%和4.2%)(x2=0.15,P=0.694)差异均无统计学意义. 结论 国产Firebird西罗莫司涂层支架与进口Cypher西罗莫司涂层支架有相同或近似的远期安全性和有效性.     

国产Firebird支架的远期安全性和有效性研究

Objective To evaluate the long-term safety and efficacy of domestic Firebird rapamycin-eluting stent in treatment of patients with coronary artery disease (CAD). Methods The 465 patients with CAD received percutaneous interventional therapy with domestic Firebird or imported Cypher rapamycin-eluting stent based on patients' will and they were followed up for more than 24 months. Results The 321 cases in Firebird group were followed up for (45.3 ±11.1)months, with 166 cases (51.7%) received reexamination by coronary angiography. The 144 patients in Cypher group were followed up for (46.1 ± 12. 1) months, with 82 patients (56.3%) received reexamination by coronary angiography. At the termination of follow-up, there were no significant differences in all-cause death (7.8% vs. 7.6 %, x2 = 1.32, P = 0. 250), cardiac death (5.9% vs.5.6%, x2 =0. 02, P=0. 877), acute myocardial infarction (2.8% vs. 3.4%, x2 =0. 15, P=0. 697),cardiovascular-cause rehospitalization (29.6% vs. 31.9 %, x2 =0.26, P=0. 610), acute and subacute thrombosis events (0.9% vs. 1.3%, x2 =0.19, P=0.661), late thrombotic events (1.2% vs.1.3%, x2 =0. 02, P=0. 900) and target lesion revascularization (3.4% vs. 4.2%, x2 =0. 15, P=0. 694) between two groups. Conclusions Domestic Firebird rapamycin-eluting stent has the same or similar long-term safety and efficacy with imported Cypher rapamycin-eluting stent.     

The long-term efficacy of conventional radiotherapy in patients with GH-secreting pituitary adenomas

OBJECTIVE: To assess the long-term efficacy and safety of conventional radiotherapy (RT) in the control of acromegaly according to recent stringent criteria of cure. DESIGN: A retrospective longitudinal study. PATIENTS AND METHODS: Forty-seven patients with active acromegaly were treated with conventional RT between 1982 and 1994. All patients were first operated on and successively irradiated at a dose of 45-50 Gy in 25-28 fractions for persistent (n = 40) or recurrent (n = 7) disease. MEASUREMENTS: Long-term GH/IGF-I secretion and local tumour control were evaluated regularly, and possible side-effects were searched for systematically, especially in terms of secondary endocrine dysfunction. Biochemical cure of acromegaly was defined by glucose-suppressed plasma GH levels below 1 microg/l during an oral glucose tolerance test (OGTT) and normal age-corrected IGF-I values. RESULTS: The 5-, 10- and 15-year overall survival rates were 98%, 95% and 93%, respectively. Suppression of GH during OGTT was seen in 9% of patients at 2 years, 29% at 5 years, 52% at 10 years, and 77% at 15 years. Age-corrected IGF-I levels were normal in 8% of patients 2 years after RT, and this proportion increased to 23%, 42% and 61% after 5, 10 and 15 years, respectively. Normalization of GH/IGF-I mainly depended on pre-RT levels. Local tumour control was 95% at 5, 10 and 15 years after treatment. Late toxicity was mainly represented by progressive hypopituitarism, which was present in 33% of patients at baseline and increased to 57%, 78% and in 85% of patients at 5 10 and 15 years after RT, respectively. CONCLUSION: Conventional RT is effective in the long-term control of GH-secreting pituitary adenomas, although with a high prevalence of progressive hypopituitarism. At present, it remains a suitable option in acromegalic patients uncontrolled by surgery or medical therapy.     

Defibrillation efficacy testing: long-term follow-up and mortality.

AIMS: Extensive defibrillation threshold testing is no longer necessary to perform as devices have become more effective. We assessed the lowest effective defibrillation (LED) level at implantation and before hospital discharge and related this to outcome. METHODS AND RESULTS: One hundred and twenty-seven consecutive patients with biphasic shock and active can devices were studied at intraoperative and predischarge testing. A subgroup of 67 patients had > or = 3 VF inductions at implant. Improvement was defined when LED decreased by > or = 3 J. The LED was significantly higher at implantation compared with predischarge (P < 0.001). Improvement was seen in 73/127 patients (58%). In the group with > or = 3 VF inductions, an implantation LED > 9 J was related to a lower LVEF (P < 0.01); 34/67 patients (51%) had improvement in LED. During follow-up, 18/127 patients died, four received heart transplantation. No different outcome was observed in patients with and without improvement. However, for those with > or = 3 VF inductions, an independent predictor of mortality was implantation LED > 9 J without improvement on the second test. Safety margin < 10 J was not related to mortality. CONCLUSION: Repeated defibrillation efficacy testing before hospital discharge may confirm that a relatively high defibrillation energy is required. This is related to a higher mortality in long-term follow-up.