Whitepaper: Training in Diagnostic and Interventional Breast Radiology. / Whitepaper: Weiterbildung in der bildgebenden und interventionellen Mammadiagnostik.

PURPOSE: Breast imaging represents an integral part of radiology and is subject to strict quality controls. Regarding this, precise diagnostics including multimodal assessment by mammography, sonography, and MRI, including image-guided biopsy and localization procedures, is often decisive and must be performed by experts with profound knowledge and skills in all of these procedures.However, due to numerous restructurings, breast imaging has been shifted more and more towards large, specialized centers, resulting in less patient exposition and training opportunities for radiologists in smaller sites. The following whitepaper summarizes the current circumstances and discusses opinions of the participating societies. MATERIALS: Under the leadership of the German Roentgen Society (DRG) and with the participation of the DRG's AG Mammadiagnostik, the CAFRAD (Chefarztforum Radiologie), the KLR (Konferenz der Lehrstuhlinhaber für Radiologie e. V.), the DRG's Forum Junge Radiologie (FJR) and the Berufsverband der Deutschen Radiologen e. V. (BDR), possible solutions were discussed and consented for a structured training in breast radiology in the future. RESULTS: In addition to the teaching provided at the primary workplace, qualified training should be ensured through flexible, multi-institutional, interdisciplinary, and cross-sectoral collaboration. Furthermore, the integration of online case collections and close cooperation with certified breast cancer centers and mammography screening units is recommended. It is indispensible that online courses and case collections adhere to the standards of the national societies and include a maximum of one third of the required cases. CONCLUSION: In order to provide training in breast radiology at a high professional level, a paradigm shift with closer cooperation of all participants is necessary. This includes close collaboration of the breast imaging societies with the federal medical associations to establish new teaching concepts like e-learning in the training schedule of radiologists. KEY POINTS: · Breast diagnostics is an integral part of radiology training.. · Due to recent restructurings, smaller training centers have difficulties in meeting the case numbers demanded by the Specialist Training Regulations (WBO). Improved integration of the new structures and their adaptation to the needs of education are necessary to guarantee standardized high-quality training of young radiologists.. · The integration of certified case collections enables quality-assured training, even across regions in online-based formats. In accordance with the "blended learning principle", up to one-third of the required number of patient studies can be substituted with cases from a certified case collection.. · Legally secured short- and medium-term internships may complement training in radiology.. CITATION FORMAT: · Sauer ST, Bley TA, Wenkel E et al. Whitepaper: Training in Diagnostic and Interventional Breast Radiology. Fortschr Röntgenstr 2023; 195: 699 - 706.

Nationwide Provision of Radiologically-guided Interventional Measures for the Supportive Treatment of Tumor Diseases in Germany - An Analysis of the DeGIR Registry Data. / Flächendeckende Versorgung mit radiologisch-interventionellen supportiven Maßnahmen bei Tumorerkrankungen und anderen Erkrankungen (DeGIR-Modul C) in Deutschland ­ Eine Analyse der DeGIR-Registerdaten.

PURPOSE: In addition to direct oncologic therapy, interventional radiology plays an important supportive role in oncologic therapy primarily guided by other disciplines. These supporting measures include diagnostic punctures, drainages, biliary interventions, central venous access including port implantations, osteoplasties, pain therapies etc.). This study investigated the extent to which these radiologically guided supportive measures are available in Germany. MATERIAL AND METHODS: All interventional procedures documented in the DeGIR-registry (excluding transhepatic portosystemic shunts) of the years 2018 and 2019 were recorded (DeGIR-module C). A breakdown of the documented interventions was performed based on federal states as well as 40 individual regions (administrative districts and former administrative districts). RESULTS: A total of 136,328 procedures were recorded at 216 centers in DeGIR Module C in 2018 and 2019. On average, 389 cases were documented per hospital in 2018 and 394 cases in 2019; the increase per hospital from 2019 is not statistically significant but is relevant in the aggregate when new participating centers are included, with an overall increase of 10 % (6,554 more cases than the previous year). Normalized to one million inhabitants, an average of 781 procedures took place across Germany in 2018 and 860 in 2019. Districts with no registered procedures are not found for Module C.Indications for Module C interventions were mostly interdisciplinary in 2018 and 2019. In this context, the quality of outcome was very high; for the procedures drain placement, marking and biopsy the technical success was 99 %, while the complication rate was lower than 1 %. CONCLUSION: The structural analysis of this work concludes that in Germany there is good nationwide availability of radiologically guided supportive measures in oncological therapy. Accordingly, the training situation for prospective interventional radiologists is good, as the distribution to centers with high experience is excellent. In addition, the overall outcome quality of radiology-guided interventions is very high. KEY POINTS: · In Germany, there is good nationwide coverage of radiologically guided supportive interventions in oncological therapy.. · The training situation for prospective interventional radiologists is good, as the distribution to centers with high experience is excellent.. · The overall outcome quality of radiology-guided interventions is very high.. CITATION FORMAT: · Nadjiri J, Schachtner B, Bücker A et al. Nationwide Provision of Radiologically-guided Interventional Measures for the Supportive Treatment of Tumor Diseases in Germany - An Analysis of the DeGIR Registry Data. Fortschr Röntgenstr 2022; 194: 993 - 1002.

Availability of Interventional Oncology in Germany in the Years 2018 and 2019 - Results from a Nationwide Database (DeGIR Registry Data). / Flächendeckende Versorgung mit radiologisch durchgeführten Verfahren zur interventionell-onkologischen Tumortherapie in Deutschland in den Jahren 2018 und 2019 dargestellt anhand der DeGIR-Registerdaten.

OBJECTIVE: Over the past few decades, radiology has established itself in tumor therapy through interventional oncology including innovative and efficient procedures for minimalinvasive treatment of various tumor entities besides the "classic" therapeutic options such as surgery, chemotherapy and radiotherapy.Aim of this study was to evaluate the extent to which interventional oncology can provide nationwide care using the data from the register of the German Society for Interventional Radiology and Minimally Invasive Therapy (DeGIR registry), which records radiological interventions as part of quality assurance. METHODS: The numbers of interventions of participating clinics, which were recorded as part of module D (oncological procedures including TACE or other tumor-specific embolization, ablation, percutaneous tumor therapy) and identified by the DeGIR registry between 2018 and 2019, were analyzed retrospectively. The collected intervention data were evaluated regarding federal states and 40 smaller regions (administrative districts and former administrative districts). RESULTS: In 2018, 11 653 oncological interventions in 187 clinics were recorded by the DeGIR registry. In 2019, the number of participating clinics rose to 216 and the number of oncological interventions increased by 6 % to 12 323. The average number of oncological interventions per clinic decreased slightly from 62.5 (2018) to 57.1 (2019). The DeGIR requirement for being certified as a training center was met by 116 clinics in 2018 including 31 clinics with more than 100 interventions and 129 clinics in 2019 including 36 with more than 100 interventions. Oncological interventions have been performed in each of the 40 regions. An average of 599 interventions per region (standard deviation of 414) was recorded in the period between 2018 and 2019. CONCLUSION: Based on the distribution of the documented oncological interventions at federal state level as well as the district level, the supply of interventional tumor therapy depends on the geographical location. Therefore, the demand of oncological interventions might not be sufficiently covered in some regions. KEY POINTS: · Interventional-oncological tumor therapies are performed throughout Germany. · Looking at the notable geographical differences, the need for interventional oncological procedures does not seem to be sufficiently met.. · In order to improve the comprehensive provision of oncological interventions, the training of interventional radiologists should be promoted further.. CITATION FORMAT: · Radosa CG, Nadjiri J, Mahnken AH et al. Availability of Interventional Oncology in Germany in the Years 2018 and 2019 - Results from a Nationwide Database (DeGIR Registry Data). Fortschr Röntgenstr 2022; 194: 755 - 761.

Availability of interventional-radiological revascularization procedures in Germany - an analysis of the DeGIR Registry Data 2018/19. / Versorgungslage mit interventionell-radiologischer Gefäßrevaskularisation in Deutschland ­ eine Analyse der DEGIR-Registerdaten 2018/19.

PURPOSE: Peripheral artery disease (PAD) is a common condition with high socio-economic relevance. Therefore, qualified nationwide provision of interventional treatments of PAD is important for maintaining a high quality medical service in Germany. MATERIALS AND METHODS: All data on revascularization procedures from the quality management system of the German interventional radiological society (DeGIR) for the years 2018 and 2019 were retrospectively analysed. Number and distribution of DeGIR certified endovascular specialists and treatment centres was mapped. Documented procedures were broken down to the level of administrative districts. Absolute number of revascularization procedures and normalized number per one million inhabitants were computed. RESULTS: In 2019 there were 57 732 revascularization procedures from 228 participating centres performed by DeGIR certified interventional radiologists. A median of 62 recanalization procedures were documented per centre. 36 centres were considered to be high volume centres, with more than 500 procedures each. On a regional level in the years 2018 and 2019 combined a median (range) of 2324 (323-12 518) revascularization procedures per administrative district were performed by DeGIR certified interventional radiologist. CONCLUSION: There is a comprehensive nationwide high quality interventional-radiology service for the provision of revascularization procedures available in Germany. KEY POINTS: · In Germany there is a nationwide comprehensive infratsructure for the interventional-radiological treatment of PAD. · The volume of interventional-radiological treatments for PAD is growing. · There is a sufficient number of training and treatment centres for the delivery of interventional radiology procedures. CITATION FORMAT: · Mahnken AH, Nadjiri J, Schachtner B et al. Availability of interventional-radiological revascularization procedures in Germany - an analysis of the DeGIR Registry Data 2018/19. Fortschr Röntgenstr 2022; 194: 160 - 168.

Availability of Transcatheter Vessel Occlusion Performed by Interventional Radiologists to Treat Bleeding in Germany in the Years 2016 and 2017 - An Analysis of the DeGIR Registry Data. / Flächendeckende Versorgung mit radiologisch durchgeführten gefäßverschließenden Maßnahmen zur interventionellen Behandlung von Blutungen in Deutschland in den Jahren 2016 und 2017 ­ Eine Analyse der DeGIR-Registerdaten.

PURPOSE: Acute bleeding is a life-threatening condition that can be effectively treated minimally invasively by interventional radiologists using transcatheter vessel occlusion (TCVO). The purpose of this study was to evaluate the availability of TCVO performed by interventional radiologists in Germany based on the DeGIR registry. MATERIALS AND METHODS: TCVO interventions from the years 2016 and 2017 were included (DeGIR module B). The number of interventions was assessed by state and region. RESULTS: TCVO interventions were reported by 242 clinics in Germany. 16 763 module B interventions were reported in 2016 and 16 399 in 2017. DeGIR requirements for certification as a training center were fulfilled by 160 facilities in 2016 and by 162 facilities in 2017. Normalized to one million citizens, an average of 211 TCVO interventions were performed in 2016 and 200 in 2017 (standard deviation was 101 and 109); the median was 202 and 222, respectively. In all regions TCVO interventions were reported. Only a minimal number of small regions showed a lower number of clinics offering TCVO interventions. CONCLUSION: The results from the DeGIR registry indicate comprehensive nationwide availability of TCVO performed by interventional radiologists with the necessary experience in Germany on the state level for the treatment of acute bleeding. Furthermore, the distribution of facilities fulfilling the requirements of training centers allows for good educational possibilities for young interventional radiologists in Germany. Only the distribution of clinics offering TCVO in a few small regions might lead to increased transfer times in the case of acute bleeding. KEY POINTS: · As a treatment for life-threatening acute bleeding in Germany, transcatheter vessel occlusion led by interventional radiologists is readily available on the state level.. · Furthermore, the distribution of facilities fulfilling the requirements of training centers allows for good educational possibilities for young interventional radiologists in Germany.. · Due to the good training conditions in Germany, it might be possible to further improve the situation in smaller regions by training more interventional radiologists and employing them in regions with less coverage.. CITATION FORMAT: · Nadjiri J, Schachtner B, Bücker A et al. Availability of Transcatheter Vessel Occlusion Performed by Interventional Radiologists to Treat Bleeding in Germany in the Years 2016 and 2017 - An Analysis of the DeGIR Registry Data. Fortschr Röntgenstr 2020; 192: 952 - 960.

Surgical management of rectal foreign bodies: a 10-year single-center experience.

BACKGROUND: Patients with a rectal foreign body (RFB) are still a rare entity in general surgery departments but with an increasing incidence over the last years. This case is sometimes difficult to treat, and due to a lack of standardized treatment options, the aim of the study was to present our clinical experiences with the diagnostic and therapeutic approach to RFBs and a review of the currently available literature. MATERIALS AND METHODS: Data were collected retrospectively from the patient's records of 20 patients who were treated due to an RFB between 2006 and 2016. Patient's demographics, circumstances of insertion, inserted objects, clinical presentation, laboratory and imaging results, as well as surgical treatment and duration of hospital stay were analyzed. Additionally, a review of the literature was performed with the search items "rectal foreign body" and "surgical therapy". Because many publications were just case reports, we did not perform a meta-analysis or a systematic review. RESULTS: Twenty-two cases in 20 patients (80% male) presented to the emergency room. The mean age was 38.5±13.7 years. In 68.2% of the cases, the cause of RFB was due to sexual preferences. The following objects were inserted: six dildos, three vibrators, two bottles, one glass, one deodorant, one apple, one fever thermometer, multiple glass fragments and razor blades in one patient and six unknown objects. For 18 RFBs, manual peranal removal without anesthesia was possible in the emergency room, but two patients required intravenous analgesia. Two patients were transferred to the operating room and the foreign body was removed via the anus under general anesthesia. Open surgery with a laparotomy was necessary for two complicated cases. One patient was in need of surgery due to a vacuum generated by the RFB, whereas the second patient suffered from a sigmoid perforation. In all cases, there was no morbidity or mortality. CONCLUSION: In most cases, the removal of an RFB can be performed peranally in the emergency room without further complications, therefore representing the therapy of choice for RFB. Only in cases with perforation, acute abdomen, or failed peranal approaches, surgery is indicated to remove the foreign body.

Neuronal Na+/K+ ATPase is an autoantibody target in paraneoplastic neurologic syndrome.

OBJECTIVES: To identify an autoreactivity in a 66-year-old woman who presented with combined brainstem and cerebellar syndrome including vertical gaze palsy, severe progressive ataxia, and spastic tetraparesis, an acute deterioration of vision, dysarthria, and dysphagia with concurrent diagnosis of a colon adenocarcinoma. METHODS: Patient's serum and CSF underwent comprehensive autoantibody screening by indirect immunofluorescence assay and immunoblot. For autoantigen purification, a histo-immunoprecipitation technique was developed followed by mass spectrometrical analysis. Recombinant candidate antigens were expressed in HEK293 and used to verify the identification. RESULTS: Indirect immunofluorescence assay screening revealed strong immunoglobulin G reactivity with neural tissues in serum and CSF, but not with a panel of 28 recombinantly expressed established neural autoantigens. The hitherto unknown target antigen was identified as the neuronal Na(+)/K(+) ATPase. Epitope mapping and competitive inhibition experiments showed that the autoantibodies were directed against the membrane-spanning alpha 3 subunit (ATP1A3) of the enzyme but did not bind to extracellular epitopes. Immunohistochemical analysis revealed overexpression of this subunit in the patient's tumor. CONCLUSIONS: We describe a case of an anti-ATP1A3-associated neurologic disorder. Mutations in the gene encoding this neuronal surface protein have already been recognized as the cause of infantile alternating hemiplegia, rapid-onset dystonia parkinsonism, and CAPOS syndrome. Although the autoantibodies are unlikely to be pathogenic, they are likely to be rare biomarkers for the apparently paraneoplastic neurologic syndrome or for the tumor itself.

Stent-assisted coil embolization of a traumatic wide-necked renal segmental artery pseudoaneurysm.

We present the case of an Afghan woman with a renal segmental artery false aneurysm of the right kidney due to a shell splinter injury. Stent-assisted coil embolization of the aneurysm is described in detail.

Impact of donor serum sodium levels on outcome after heart transplantation.

We investigated the impact of elevated donor serum sodium levels on outcome after heart transplantation in 336 consecutive heart transplantations. Mean donor serum sodium was 148.2+/-10.2 mmol/liter (range 116 to 180 mmol/liter). Recipients were divided into 4 groups with serum sodium levels of 141, 147 and 155 mmol/liter, resulting in sodium levels of: 133+/-6.1 mmol/liter for Quartile A; 144+/-4.2 mmol/liter for Quartile B; 151+/-4.3 mmol/liter for Quartile C; and 162+/-6.6 mmol/liter for Quartile D, respectively (mean+/- standard deviation). Mean occurrence of primary graft failure (PGF) was 3.6% with the following quartile breakdown: A, 3.6%; B, 4.8%; C, 3.6%; and D, 2.4% (p=non-significant [NS]). Mean 5-year survival was 81.32% with: A, 83.51%; B, 76.03%; C, 80.47%; and D, 85.25% (p=NS). Coronary allograft vasculopathy (CAV) occurred in 19% of patients with a quartile breakdown of: A, 16.5%; B, 21%; C, 20%; and D, 14.5% (p=NS). No impact of donor serum sodium levels was seen on early post-operative results or on long-term outcome, indicating that cardiac allografts from donors with elevated sodium levels may be transplanted successfully with favorable results.

Tacrolimus or cyclosporine: which is the better partner for mycophenolate mofetil in heart transplant recipients?

BACKGROUND: The aim of this single-center study was to investigate whether trough level adjusted mycophenolate mofetil (MMF) is more efficacious in combination with tacrolimus (TAC) or cyclosporine (CsA) and to evaluate the impact of either drug on MMF dosage. METHODS: Sixty patients (TAC, n = 30; CsA, n = 30) undergoing heart transplantation were randomized into a prospective, open-label, controlled trial. Immunosuppression consisted of TAC or CsA in combination with MMF and corticosteroids. Target blood trough levels of TAC, CsA, and mycophenolic acid (MPA) were in the range of 10 to 15 ng/mL, 100 to 300 ng/mL, and 1.5 to 4.0 microg/mL, respectively. Acute rejection episodes (ARE); survival data; and adverse events with a special emphasis on infections, diabetes, hypertension, hypercholesterolemia, and the development of graft vessel disease (GVD) were recorded. RESULTS: Baseline characteristics were well balanced. All patients were successfully withdrawn from corticosteroids within 6 months of transplant. Freedom from acute rejection was significantly higher (P = 0.0001) and the incidence of ARE per 100 patient days significantly lower in the TAC-MMF group than in the CsA-MMF group (0.03 vs. 0.15; P = 0.00007). Overall patient survival during follow-up was similar (93% vs. 90%). To achieve the targeted MPA blood levels, a significantly lower dose of MMF was required for TAC versus CsA patients. After a follow-up time of 2 years, the mean GVD score was 1.85 +/- 3.18 in the TAC-MMF group and 3.95 +/- 4.8 in the CsA-MMF group (P = 0.08). CONCLUSIONS: At the selected doses and target levels for TAC and CsA used in this study, trough level adjusted MMF was more efficacious in combination with TAC for prevention of ARE. Furthermore, CsA patients need significantly more MMF to achieve similar MPA levels.

Sirolimus impairs gonadal function in heart transplant recipients.

The impact of sirolimus on hormone levels involved in the hypothalamus-pituitary-gonad axis in male heart transplant recipients was investigated. A pair-matched analysis with 132 male heart transplant recipients on either sirolimus based- or calcineurin inhibitor-based immunosuppression was performed. Matching criteria were age, years after transplantation and creatinine levels. Measured parameters were testosterone, luteinizing hormone (LH), follicle stimulating hormone (FSH), sexual hormone-binding globulin (SHBG) and free androgen index (FAI). Mean testosterone was 3.86 +/- 1.41 ng/mL in the sirolimus group and 4.55 +/- 1.94 ng/mL in the controls (p = 0.025). Serum LH was 12.82 +/- 11.19 mlU/mL in the sirolimus patients and 6.2 +/- 5.25 mlU/mL in the controls (p = 0.015). Follicle stimulating hormone levels were 13.31 +/- 18.4 mlU/mL vs. 7.32 +/- 5.53 mlU/mL, respectively (p = 0.015). The analysis revealed a significant decrease in testosterone and a significant increase in FSH and LH in the sirolimus group. The duration of sirolimus treatment correlated positively with SHBG (p < 0.01), LH (p < 0.05) and FSH (p < 0.05) and negative with the FAI (p < 0.05). Sirolimus trough levels correlated with LH and FSH levels (p < 0.01). Heart transplant recipients treated with sirolimus revealed significantly lower testosterone levels and a significant increase in gonadotropic hormones. These effects were trough-level dependent. All candidates awaiting organ transplantation should be informed about these adverse effects.

Mycophenolate mofetil and sirolimus as calcineurin inhibitor-free immunosuppression for late cardiac-transplant recipients with chronic renal failure.

BACKGROUND: Calcineurin-inhibitor (CNI)-related renal failure is a common problem after cardiac transplantation (HTx). The aim of this study was to introduce a CNI-free immunosuppressive regimen to HTx recipients with late posttransplant renal impairment and to evaluate the impact of conversion to this new immunosuppression (mycophenolate mofetil [MMF] and sirolimus [Sir]) treatment on renal function. METHODS AND RESULTS: Thirty-one HTx patients (25 men, 6 women; 0.2-14.2 years after transplantation) with CNI-based immunosuppression and a serum creatinine greater than 1.9 mg/dL were included in the study. Creatinine and cystatin levels were monitored to detect renal function. Mean patient age was 50+/-14 (range 19-74) years. Conversion was started with 6 mg Sir, continued with 2 mg, and the dose was adjusted to achieve target trough levels between 8 and 14 ng/mL. MMF was continued with trough level adjusted (1.5-4 microg/mL). Subsequently, the CNIs were tapered down and stopped. Clinical follow-up (first and every 3 months after conversion) included endomyocardial biopsies, echocardiography, and laboratory studies. Survival was 90% after a mean follow-up of 13+/-95 months. No acute rejection episode was detected during the study period. Renal function improved significantly after conversion: creatinine preconversion vs. postconversion: 3.14+/-0.76 mg/dL vs. 2.14+/-0.83 mg/dL, P =0.001. Cystatin preconversion vs. postconversion: 2.95+/-1.06 mg/L vs. 2.02+/-1.1 mg/L, P =0.01. In three patients, hemodialysis therapy was stopped completely after conversion. Graft function remained stable. Fractional shortening preconversion vs. postconversion: 36.9+/-6% vs. 36.4+/-6%. There were no serious adverse events. One patient had to be excluded because of noncompliance. CONCLUSIONS: Conversion from CNI-based immunosuppression to MMF and Sir in HTx patients with chronic renal failure was safe, preserved graft function, and improved renal function.

Renal recovery after conversion to a calcineurin inhibitor-free immunosuppression in late cardiac transplant recipients.

OBJECTIVE: Calcineurin inhibitor (CNI)-related renal failure is a common problem after cardiac transplantation (HTx). The aim of this prospective study was to evaluate the safety and efficacy of a completely CNI-free immunosuppressive regimen [mycophenolate mofetil (MMF) and sirolimus (Sir)] in HTx-recipients with late post-transplant renal impairment. METHODS: Since 2001, 30 HTx-patients (25 men, 6 women; 0.2-14.2 years after transplantation) with CNI-based immunosuppression and a serum creatinine >1.9 mg/dl were included in the study. Creatinine and cystatin levels were monitored to detect renal function. Conversion was started with 6 mg Sir or 500 mg MMF according to the pre-existing regimen and was continued with the dose adjusted to achieve target trough levels between 8 and 14 ng/ml (Sir) or 1.5 and 4 microg/ml (mycophenolate). Subsequently, the CNIs were tapered down and stopped. Clinical follow-up included endomyocardial biopsies, echocardiography and laboratory studies. Additionally, every HTx-patient treated at our centre between 1996 and 2001 due to chronic renal failure without immunosuppressive conversion and fulfilling the inclusion criteria were retrospectively analysed and acted as control group. RESULTS: Patient demographics and 1-year survival [93 (conversion) vs 90% (control)] were compared. No acute rejection episode was detected in either group. Renal function improved significantly in the conversion group (creatinine: 3.18+/-0.71 vs 2.22+/-0.79 mg/dl, P=0.001; cystatin pre- vs post-conversion: 2.95+/-1.06 vs 2.02+/-1.1 mg/l, P=0.01). In three patients haemodialysis therapy was stopped completely after conversion. In the control group renal impairment was deteriorating, creatinine increased from 2.44+/-0.8 to 3.28+/-1 mg/dl (P=0.01). In 10 out of 33 patients chronic haemodialysis had to be initiated within 1 year. Although side effects of CNI-free immunosuppression were common (76%), no patient had to be excluded due to adverse effects. CONCLUSIONS: Conversion from CNI-based immunosuppression to MMF and Sir in HTx-patients with chronic renal failure was safe, preserved graft function and improved renal function.

Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results.

BACKGROUND: Stent implantation for obstructive femoropopliteal artery disease has been associated with poor long-term outcomes. This study evaluated the effectiveness of shape memory alloy recoverable technology (SMART) nitinol self-expanding stents coated with a polymer impregnated with sirolimus (rapamycin) versus uncoated SMART Stents in superficial femoral artery obstructions. METHODS AND RESULTS: Thirty-six patients were recruited for this double-blind, randomized, prospective trial. All patients had chronic limb ischemia and femoral artery occlusions (57%) or stenoses (average lesion length, 85 +/- 57 mm). Patients were eligible for randomization after successful guidewire passage across the lesion. Eighteen patients received sirolimus-eluting SMART Stents and 18 patients received uncoated SMART Stents. The primary end point of the study was the in-stent mean percent diameter stenosis, as measured by quantitative angiography at 6 months. The instent mean percent diameter stenosis was 22.6% in the sirolimus-eluting stent group versus 30.9% in the uncoated stent group (P = 0.294). The in-stent mean lumen diameter was significantly larger in the sirolimus-eluting stent group (4.95 mm versus 4.31 mm in the uncoated stent group; P = 0.047). No serious adverse events (death or prolonged hospitalization) were reported. CONCLUSIONS: The use of sirolimus-eluting SMART Stents for superficial femoral artery occlusion is feasible, with a trend toward reducing late loss compared with uncoated stents. The coated stent also proved to be safe and was not associated with any serious adverse events.