Chio A.,University of Turin |
Mora G.,Fondazione Salvatore Maugeri |
Bonito V.,Ospedale Papa Giovanni XXIII |
Filippini G.,Instituto Neurologico Carlo Besta
Journal of Neurology, Neurosurgery and Psychiatry | Year: 2015
Background Staging of disease severity is useful for prognosis, decision-making and resource planning. However, no commonly used, validated staging system exists for amyotrophic lateral sclerosis (ALS). Our purpose was to develop an ALS staging system (ALS Milano-Torino Staging) that captures the observed progressive loss of independence and function. Methods Clinical milestones in ALS progression were defined by loss of independence in four key domains on the ALS Functional Rating Scale (ALSFRS): swallowing, walking/self-care, communicating and breathing. Stages were defined as follows: stage 0, functional involvement but no loss of independence on any domain; stages 1-4, number of domains in which independence was lost; and stage 5, death. Staging criteria were applied to patients enrolled in a Quality of Care in ALS (QOC) study; endpoints included function (ALSFRS), quality of life (QOL; Short Form-36) and health service costs. Between-stage transition probabilities were assessed in the QOC study and in a second clinical study of lithium carbonate in ALS. Results 70/118 (59.3%) participants in the QOC study progressed to higher stages of disease at 12 months compared with their baseline stage. Functional (ALSFRS) and QOL measures were inversely related to disease stage. Health service costs were directly related to increasing disease stages from 0 to 4 (p<0.001). Probabilities for transitioning from a given stage at baseline in both studies were usually greatest for the next highest stage. Conclusions The proposed ALS Milano-Torino Staging system correlates well with assessments of function, QOL and health service costs. Further studies are warranted to validate this system.
Bivalirudin versus heparin with or without glycoprotein IIb/IIIa inhibitors in patients with STEMI undergoing primary percutaneous coronary intervention: Pooled patient-level analysis from the HORIZONS-AMI and EUROMAX Trials
Stone G.W.,Columbia University |
Mehran R.,Mount Sinai Medical Center |
Goldstein P.,Lille University Hospital Center |
Witzenbichler B.,Helios Amperkliniken AG |
And 12 more authors.
Journal of the American College of Cardiology | Year: 2015
Background In the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trial, 3,602 patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) treated with bivalirudin had lower bleeding and mortality rates, but higher acute stent thrombosis rates compared with heparin + a glycoprotein IIb/IIIa inhibitor (GPI). Subsequent changes in primary PCI, including the use of potent P2Y12 inhibitors, frequent radial intervention, and pre-hospital medication administration, were incorporated into the EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trial, which assigned 2,218 patients to bivalirudin versus heparin ± GPI before primary PCI.Objectives The goal of this study was to examine the outcomes of procedural anticoagulation with bivalirudin versus heparin ± GPI for primary PCI, given the evolution in primary PCI.Methods Databases from HORIZONS-AMI and EUROMAX were pooled for patient-level analysis. The Breslow-Day test evaluated heterogeneity between trials.Results A total of 5,800 patients were randomized to bivalirudin (n = 2,889) or heparin ± GPI (n = 2,911). The radial approach was used in 21.3% of patients, prasugrel/ticagrelor was used in 18.1% of patients, and GPI was used in 84.8% of the control group. Bivalirudin compared with heparin ± GPI resulted in reduced 30-day rates of major bleeding (4.2% vs. 7.8%; relative risk [RR]: 0.53; 95% confidence interval [CI]: 0.43 to 0.66; p < 0.0001), thrombocytopenia (1.4% vs. 2.9%, RR: 0.48; 95% CI: 0.33 to 0.71; p = 0.0002), and cardiac mortality (2.0% vs. 2.9%; RR: 0.70; 95% CI: 0.50 to 0.97; p = 0.03), with nonsignificantly different rates of reinfarction, ischemia-driven revascularization, stroke, and all-cause mortality. Bivalirudin resulted in increased acute (<24 h) stent thrombosis rates (1.2% vs. 0.2%; RR: 6.04; 95% CI: 2.55 to 14.31; p < 0.0001), with nonsignificantly different rates of subacute stent thrombosis. Composite net adverse clinical events were lower with bivalirudin (8.8% vs. 11.9%; RR: 0.74; 95% CI: 0.63 to 0.86; p < 0.0001). There was no significant heterogeneity between the 2 trials for these outcomes, and results were consistent across major subgroups.Conclusions Despite increased acute stent thrombosis, primary PCI with bivalirudin improved 30-day net clinical outcomes, with significant reductions in major bleeding, thrombocytopenia, and transfusions compared with heparin ± GPI, results that were consistent with evolution in PCI technique and pharmacotherapy. (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966) (European Ambulance Acute Coronary Syndrome Angiography [EUROMAX]; NCT01087723). © 2015 American College of Cardiology Foundation.
News Article | November 7, 2016
WASHINGTON - Nov. 2, 2016 - Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OCT) to evaluate strut coverage and neoatherosclerosis (NA) found that bioresorbable polymer-based drug-eluting stents (BP-EES) are comparable to durable polymer-based drug-eluting stents (DP-ZES). Findings were reported today at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. To mitigate the risk related to durable polymer (DP), bioabsorbable polymers (BP) that coat only the abluminal side of the stent, avoiding contact with circulating blood, and render stent surface similar to those of BMS after complete absorption, have been developed. Whether BP abluminal coating may counteract in-vivo delayed healing and NA development in current thin-strut DES is unknown. TRANSFORM-OCT randomized 90 patients with multivessel disease (1:1) to a BP everolimus-eluting stent (BP-EES, Synergy) or a DP zotarolimus-eluting stent (DP-ZES, Resolute Integrity). The primary endpoints were maximum length of consecutive frames with uncovered struts at three months (powered for non-inferiority of BP-EES) and the percentage of patients presenting with frames of NA at 18 months (powered for superiority of BP-EES) as measured by OCT. The three-month median percentage of covered struts was 79.1 (IQR 60.4, 89.8) for BP-EES and 78.4 (IQR 62.1, 87.8) for DP-ZES, P=0.93. The 18-month median percentage of covered struts was 99.4 (IQR 96.6-100) for BP-EES and 98.0 (IQR 94.4-99.8) for DP-ZES, P=0.14. The co-primary endpoint of in-stent NA at 18 months from 98.9% of all eligible patients was 11.6 % for BP-EES versus 15.9% in DP-ZES (P=0.59) with low percentage of frames with NA in both stent types (1.1 ± 3.1 for BP-EES versus 2.5 ± 9.1 for DP-ZES, P=0.33) "In this head-to-head in-vivo comparison of early and late healing response, the bioresorbable abluminal polymer Synergy everolimus-eluting stent was non-inferior at 3-month and similar at 18-month follow-up to the durable conformal polymer Resolute zotarolimus-eluting stent," said Giulio Guagliumi, MD with Ospedale Giovanni XXIII in Bergamo, Italy. "TRANSFORM-OCT adds a novel mechanistic dimension to the assessment of new-generation drug-eluting stents, consolidating the understanding that well designed and biocompatible polymers, regardless of whether they are durable or biodegradable, may favorably impact the long-term vascular response of these stents." The TRANSFORM-OCT trial was designed, promoted and implemented by Ospedale Papa Giovanni XXIII, Bergamo (Italy) with unrestricted financial support provided by Boston Scientific International. The company was not involved with any of the study processes, including site selection, data collection, analysis, and drafting of the present abstract. Dr. Guagliumi reported consultant agreements with Boston Scientific and St. Jude Medical and receive research grants through the hospital by Abbott Vascular, St Jude Medical and Boston Scientific. The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease. Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. For more information, visit http://www. and http://www. .
News Article | November 21, 2016
A high-risk subtype of acute lymphoblastic leukemia (ALL) first identified in children is highly prevalent in adults with ALL and is associated with a poor outcome, according to an international collaboration led by St. Jude Children's Research Hospital. The findings, published today in the Journal of Clinical Oncology, suggest that affected patients may benefit from treatment with available medications. The study of 798 adults, who were between the ages of 21 and 86 years old when their cancer was diagnosed, showed that 194 patients, almost 25 percent, had the high-risk subtype Philadelphia chromosome-like ALL (Ph-like ALL). Many patients had genetic changes that suggest they may be treatable with targeted agents known as tyrosine kinase inhibitors, including dasatinib, imatinib and ruxolitinib. The drugs are already widely used to treat other types of leukemia that are common in adults. "This study establishes that a large percentage of adults with ALL have this high-risk subtype," said corresponding author Charles Mullighan, M.D., MBBS, a member of the St. Jude Department of Pathology. "The finding provides a compelling reason to identify those with Ph-like ALL and move forward with clinical trials of these targeted therapies in combination with current chemotherapeutic regimens." ALL is less common in adults than in children, but adults are far less likely to survive. Adults make up about 40 percent of the estimated 6,590 new cases of ALL identified annually in the U.S. At St. Jude, about 94 percent of pediatric ALL patients are alive five years after diagnosis. In this study, adults with Ph-like ALL had a five-year survival rate of 23.8 percent compared to 52.4 percent for adults with other ALL subtypes. The study builds on previous research from St. Jude, the federally funded Children's Oncology Group and other adult cooperative groups that identified Ph-like ALL as a distinct subtype of ALL first in children and then in young adults. "Our 2014 findings that the prevalence of Ph-like ALL increased with age and was particularly common in young adults generated tremendous interest because adult ALL is difficult to treat," Mullighan said. "In this study we determined that the prevalence remains high across the age spectrum of adults with ALL." Researchers used gene expression profiling to identify cases of Ph-like ALL. The incidence among adults with ALL peaked at 27.9 percent in young adults between the ages of 21 and 39 years old. It remained 20 percent or more in patients between 40 and 86 years old. Detailed genomic analysis of 180 of the Ph-like ALL cases showed that 88 percent of patients had genetic alterations fueling the cell proliferation that is a hallmark of cancer. The alterations result in abnormal activation of cell surface proteins called cytokine receptors or enzymes called kinases that cytokine receptors regulate. Tyrosine kinase inhibitors are designed to block different cytokine receptor signaling pathways. For example, dasatinib works by inhibiting ABL1 proteins while ruxolitinib targets the JAK2 protein. "Our comprehensive sequencing showed that Ph-like ALL in adults is the most genetically diverse subtype of leukemia that has been described," said first author Kathryn Roberts, Ph.D., a St. Jude staff scientist. "Cumulatively more than 50 different chromosomal rearrangements involving 15 different kinases and cytokine receptors have been identified. In this study, we identified 11 chromosomal rearrangements that are new to Ph-like ALL." The diversity of kinase-activating alterations in Ph-like ALL has important clinical implications, said co-author Hagop Kantarjian, M.D., of the University of Texas MD Anderson Cancer Center, Houston. "It is important that we now identify patients with Ph-like ALL at diagnosis to provide optimal treatment with targeted agents," he said. The findings also highlight the importance of centralized comprehensive genomic sequencing for patients, said co-author Elisabeth Paietta, Ph.D., of the Montefiore Health System and Albert Einstein College of Medicine. "Lymphoblasts from almost half of the patients with Ph-like ALL harbor a genomic rearrangement of CRLF2 (cytokine receptor-like factor 2), which can be detected by flow cytometry using an antibody to CRLF2. This is very important as it allows a quick characterization of this Ph-like ALL subtype, prior to any detailed sequencing," she said. The study reflects a growing effort to understand cancer genetics across the age spectrum. "We have recognized for many years that childhood ALL does not exist in isolation, but is a subset of a disease that affects people of varying ages," Mullighan said. The study's other authors are Zhaohui Gu, Debbie Payne-Turner, Kelly McCastlain, Deqing Pei, Ilaria Iacobucci, Marcus Valentine, Stanley Pounds, Lei Shi, Yongjin Li, Jinghui Zhang and Cheng Cheng, all of St. Jude; Richard Harvey, I-Ming Chen and Cheryl Willman, all of University of New Mexico Cancer Center, Albuquerque; Alessandro Rambaldi, Manuela Tosi and Orietta Spinelli, all of Ospedale Papa Giovanni XXIII, Italy; Jerald Radich, Fred Hutchinson Cancer Research Center, Seattle; Mark Minden, Princess Margaret Cancer Centre, Toronto; Jacob Rowe, Shaare Zedek Medical Center, Jerusalem; Selina Luger, Abramson Cancer Center, University of Pennsylvania; Mark Litzow, Mayo Clinic, Rochester, Minn.; Martin Tallman, Memorial Sloan Kettering Cancer Center, New York; Peter Wiernik, Cancer Research Foundation of New York, Bronx; Ravi Bhatia, The University of Alabama at Birmingham; Ibrahim Aldoss and Guido Marcucci, both of City of Hope National Medical Center, Duarte, Calif.; Jessica Kohlschmidt, Krzysztof Mrozek and Clara Bloomfield, all of The Ohio State University, Columbus; Wendy Stock, University of Chicago Medical Center; and Stephen Kornblau and Marina Konopleva, both of MD Anderson Cancer Center. The research was funded in part by Stand Up to Cancer; the St. Baldrick's Foundation; the American Society of Hematology; the Lady Tata Memorial Trust; the Leukemia Research Foundation; grants (CA21765, HHSN261200800001E, CA157937, CA180861, CA196171, CA145707) from the National Cancer Institute, part of the National Institutes of Health (NIH); grants (CA180820, CA180827, CA21115, CA180791, CA14958, CA189859, CA15488, CA17145, CA13650, CA180790) from the NIH; and ALSAC.
Imazio M.,Maria Vittoria Hospital |
Brucato A.,Ospedale Papa Giovanni XXIII |
Cemin R.,San Maurizio Regional Hospital |
Ferrua S.,Ospedale degli Infermi |
And 9 more authors.
New England Journal of Medicine | Year: 2013
BACKGROUND: Colchicine is effective for the treatment of recurrent pericarditis. However, conclusive data are lacking regarding the use of colchicine during a first attack of acute pericarditis and in the prevention of recurrent symptoms. METHODS: In a multicenter, double-blind trial, eligible adults with acute pericarditis were randomly assigned to receive either colchicine (at a dose of 0.5 mg twice daily for 3 months for patients weighing >70 kg or 0.5 mg once daily for patients weighing ≤70 kg) or placebo in addi;tion to conventional antiinflammatory therapy with aspirin or ibuprofen. The primary study outcome was incessant or recurrent pericarditis. RESULTS: A total of 240 patients were enrolled, and 120 were randomly assigned to each of the two study groups. The primary outcome occurred in 20 patients (16.7%) in the colchicine group and 45 patients (37.5%) in the placebo group (relative risk reduction in the colchicine group, 0.56; 95% confidence interval, 0.30 to 0.72; number needed to treat, 4; P<0.001). Colchicine reduced the rate of symptom persistence at 72 hours (19.2% vs. 40.0%, P=0.001), the number of recurrences per patient (0.21 vs. 0.52, P=0.001), and the hospitalization rate (5.0% vs. 14.2%, P=0.02). Colchicine also improved the remission rate at 1 week (85.0% vs. 58.3%, P<0.001). Overall adverse effects and rates of study-drug discontinuation were similar in the two study groups. No serious adverse events were observed. CONCLUSIONS: In patients with acute pericarditis, colchicine, when added to conventional anti-inflammatory therapy, significantly reduced the rate of incessant or recurrent pericarditis. Copyright © 2013 Massachusetts Medical Society.
Finazzi G.,Ospedale Papa Giovanni XXIII |
De Stefano V.,Catholic University |
Barbui T.,Ospedale Papa Giovanni XXIII |
Barbui T.,Hospital Papa Giovanni XXIII
Current Hematologic Malignancy Reports | Year: 2013
A high risk of arterial and venous thrombosis is the hallmark of chronic myeloproliferative neoplasms (MPNs), particularly polycythemia vera (PV) and essential thrombocythemia (ET). Clinical aspects, pathogenesis and management of thrombosis in MPN resemble those of other paradigmatic vascular diseases. The occurrence of venous thrombosis in atypical sites, such as the splanchnic district, and the involvement of plasmatic prothrombotic factors, including an acquired resistance to activated protein C, both link MPN to inherited thrombophilia. Anticoagulants are the drugs of choice for these complications. The pathogenic role of leukocytes and inflammation, and the high mortality rate from arterial occlusions are common features of MPN and atherosclerosis. The efficacy and safety of aspirin in reducing deaths and major thrombosis in PV have been demonstrated in a randomized clinical trial. Finally, the Virchow's triad of impaired blood cells, endothelium and blood flow is shared both by MPN and thrombosis in solid cancer. Phlebotomy and myelosuppressive agents are the current therapeutic options for correcting these abnormalities and reducing thrombosis in this special vascular disease represented by MPN. © 2013 Springer Science+Business Media New York.
Barbui T.,Ospedale Papa Giovanni XXIII |
Thiele J.,University of Cologne |
Vannucchi A.M.,University of Florence |
Tefferi A.,Mayo Medical School
Leukemia | Year: 2014
The aim of this review is to critically address the validity and clinical applicability of three major diagnostic classification systems for polycythemia vera (PV), that is, those proposed by the Polycythemia Vera Study Group (PVSG), the British Committee for Standards in Haematology (BCSH) and the World Health Organization (WHO). Special focus is on which one of the three red cell parameters (hemoglobin - HB, hematocrit - HCT and red cell mass - RCM) should be used as the diagnostic hallmark of PV. The revised BCSH employed a persistently raised HCT level as the first diagnostic criterion in combination with the presence of a JAK2V617F mutation. On the other hand, the WHO classification used a raised HB value as a surrogate for increased RCM in association with molecular markers and for the first time, the bone marrow (BM) morphology was included as a minor criterion. Ongoing controversy and discussion regards the use of certain threshold values for HCT and HB as surrogates for RCM as well as the existence of prodromal-latent disease, so-called masked PV (mPV). It has been shown that mPV can be recognized in patients not meeting the required HB or HCT threshold levels by both the WHO and BCSH criteria. These cases present with the same baseline clinical features as overt PV but present worsened survival. A critical reappraisal of the WHO criteria may suggest either to reduce the thresholds for HB or to consider HCT values as major diagnostic criterion, as in the BCSH, in association with JAK2V617F mutation. The clinical utility of using HCT as reference variable is supported also by results of clinical trials which explicitly recommend to use the HCT threshold for monitoring treatment. In questionable cases as in mPV, BM biopsy examinations should be mandated together with mutation analysis. © 2014 Macmillan Publishers Limited.
Subclinical carotid atherosclerosis and early vascular aging from long-term low-dose ionizing radiation exposure: A genetic, telomere, and vascular ultrasound study in cardiac catheterization laboratory staff
Andreassi M.G.,CNR Institute of Clinical Physiology |
Piccaluga E.,Ospedale L. Sacco |
Gargani L.,CNR Institute of Clinical Physiology |
Sabatino L.,CNR Institute of Clinical Physiology |
And 6 more authors.
JACC: Cardiovascular Interventions | Year: 2015
Objectives This study sought to assess the association between long-term radiation exposure in the catheterization laboratory (cath lab) and early signs of subclinical atherosclerosis. Background There is growing evidence of an excess risk of cardiovascular disease at low-dose levels of ionizing radiation exposure. Methods Left and right carotid intima-media thickness (CIMT) was measured in 223 cath lab personnel (141 male; age, 45 ± 8 years) and 222 unexposed subjects (113 male; age, 44 ± 10 years). Leukocyte telomere length (LTL) was evaluated by quantitative reverse transcriptase polymerase chain reaction. The DNA repair gene XRCC3 Thr241Met polymorphism was also analyzed to explore the possible interaction with radiation exposure. The occupational radiological risk score (ORRS) was computed for each subject on the basis of the length of employment, individual caseload, and proximity to the radiation source. A complete lifetime effective dose (mSv) was recorded for 57 workers. Results Left, right, and averaged CIMTs were significantly increased in high-exposure workers compared with both control subjects and low-exposure workers (all p values <0.04). On the left side, but not on the right, there was a significant correlation between CIMT and ORRS (p = 0.001) as well as lifetime dose (p = 0.006). LTL was significantly reduced in exposed workers compared with control subjects (p = 0.008). There was a significant correlation between LTL and both ORRS (p = 0.002) and lifetime dose (p = 0.03). The XRCC3 Met241 allele presented a significant interaction with high exposure for right side (pinteraction = 0.002), left side (pinteraction < 0.0001), and averaged (pinteraction < 0.0001) CIMTs. Conclusions Long-term radiation exposure in a cath lab may be associated with increased subclinical CIMT and telomere length shortening, suggesting evidence of accelerated vascular aging and early atherosclerosis. © 2015 American College of Cardiology Foundation.
Fagiuoli S.,Ospedale Papa Giovanni XXIII |
Daina E.,Instituto Of Ricerche Farmacologiche Mario Negri Irccs |
D'Antiga L.,Paediatric Hepatology |
Colledan M.,Ospedale Papa Giovanni XXIII |
Remuzzi G.,Instituto Of Ricerche Farmacologiche Mario Negri Irccs
Journal of Hepatology | Year: 2013
While the prevalence of most diseases caused by single-gene mutations is low and defines them as rare conditions, all together, monogenic diseases account for approximately 10 in every 1000 births according to the World Health Organisation. Orthotopic liver transplantation (LT) could offer a therapeutic option in monogenic diseases in two ways: by substituting for an injured liver or by supplying a tissue that can replace a mutant protein. In this respect, LT may be regarded as the correction of a disease at the level of the dysfunctional protein. Monogenic diseases that involve the liver represent a heterogeneous group of disorders. In conditions associated with predominant liver parenchymal damage (i.e., genetic cholestatic disorders, Wilson's disease, hereditary hemochromatosis, tyrosinemia, α1 antitrypsin deficiency), hepatic complications are the major source of morbidity and LT not only replaces a dysfunctional liver but also corrects the genetic defect and effectively cures the disease. A second group includes liver-based genetic disorders characterised by an architecturally near-normal liver (urea cycle disorders, Crigler-Najjar syndrome, familial amyloid polyneuropathy, primary hyperoxaluria type 1, atypical haemolytic uremic syndrome-1). In these defects, extrahepatic complications are the main source of morbidity and mortality while liver function is relatively preserved. Combined transplantation of other organs may be required, and other surgical techniques, such as domino and auxiliary liver transplantation, have been attempted. In a third group of monogenic diseases, the underlying genetic defect is expressed at a systemic level and liver involvement is just one of the clinical manifestations. In these conditions, LT might only be partially curative since the abnormal phenotype is maintained by extrahepatic synthesis of the toxic metabolites (i.e., methylmalonic acidemia, propionic acidemia). This review focuses on principles of diagnosis, management and LT results in both paediatric and adult populations of selected liver-based monogenic diseases, which represent examples of different transplantation strategies, driven by the understanding of the expression of the underlying genetic defect. © 2013 European Association for the Study of the Liver.
Castelli C.C.,Ospedale Papa Giovanni XXIII |
Gotti V.,Ospedale Papa Giovanni XXIII |
Ferrari R.,Ospedale Papa Giovanni XXIII
International Orthopaedics | Year: 2014
Purpose: Infection following knee replacement is an important cause of failure despite rigorous prophylaxis antibiotic protocols. The two-stage reimplantation procedure is considered the gold standard for treatment of subacute and chronic deep periprosthetic infections. The purpose of this study was to determine whether or not a preformed articulated spacer would allow comparable eradication of infection equal to rates reported in published studies and to see whether there is a resulting improvement in postoperative function with an acceptable quality of life, reducing postoperative pain and limiting surgical complications, thus simplifying the second stage of the procedure. Methods: We retrospectively reviewed 50 patients with infected TKA who underwent a two-stage exchange arthroplasty using an articulating preformed spacer. The device, designed like an ultracongruent condylar knee prosthesis, is composed of acrylic cement impregnated with antibiotic, with tested and standardised mechanical properties and antibiotic content and release mechanism. Results: The median follow-up period was seven (two to 13) years. Two-stage exchange arthroplasty was successful in controlling the infection in 92 % of patients; 64% of patients where women, and median patient age was 68 (54-80) years. Median implantation time of the preformed spacer was 16 (four to 60) weeks; 4 % of infections were delayed, and 96 % were late. Forty-six percent were caused by coagulase-negative Staphylococcus (CoNS). Mean Knee Society Score (KSS) was 35.38 (clinical) and 37.96 (function) on presentation; it improved to a mean of 72.92 (clinical) and 76.04 (function) after the first stage and to a mean of 75.38 (clinical) and 80.58 (function) at the final review. Bone loss was unchanged between stages, and range of motion remained unchanged or improved after definitive reimplantation. Conclusion: The use of preformed articulated knee spacer during a two stage technique for infected TKA improves patient QOL between stages and increases patient compliance and cooperation, reducing social costs. © 2014 Springer-Verlag Berlin Heidelberg.