Dual-layered micromesh stent technology for embolic prevention in carotid revascularization: technical experience and clinical outcomes from a high-volume interventional radiology center.

BACKGROUND: Carotid artery stenting (CAS) has become a cornerstone of carotid revascularization for stroke prevention. Despite the advantages of CAS, large-scale randomized trials involving prior (single-layer) generation of carotid stents demonstrated its higher risk of periprocedural cerebrovascular events compared to carotid endarterectomy (CEA). Dual-layer mesh-covered stents (DLSs) showed promising results in terms of 30-day embolic events. This study aims to evaluate 30-day clinical efficacy of DLS against a closed-cell single-layer stent, based on large-volume data. METHODS: The study center is part of the Italian National Outcomes Evaluation Program (PNE). CAS procedures performed between November 2017 and September 2023 were retrospectively analyzed. Our primary endpoint was 30-day survival free of death, stroke, and myocardial infarction (MI). Periprocedural stroke rate, technical success and restenosis rate of CAS procedures performed with DLSs and first-generation stents (FGSs) were also evaluated. RESULTS: Over a total of 1101 CAS procedures (55 men; 745 males; mean age of 79±7.8 years), 80.2% were treated with DLS and 48.6% were symptomatic. The cumulative stroke-, MI- and death-free 30-day survival was 98.9%, Technical success was achieved in 98.9% of cases. The DLS group showed significantly lower 30-day death, stroke and death+stroke and periprocedural minor stroke rates compared to FGS group (P=0.04; P=0.04; P=0.003 and P=0.0002, respectively). CONCLUSIONS: The use of DLS in patients undergoing CAS in our large-volume center showed a high technical success rate and minimal cerebral embolic complications by 30 days. High volumes and an experienced interventional team may contribute to these favorable outcomes.

The role of post-dilatation in carotid MicroNet-covered stent implantation, evaluated using 3D cone-beam CT angiography.

BACKGROUND: This study aims to assess the role and safety of post-dilatation in protected carotid artery stenting (PCAS) using the new MicroNet-covered 2nd-generation stent assessed by cone beam CT scans. METHODS: From March 2020 to March 2022, patients were enrolled in the study according to CT angiography results based on the following criteria: Evidence of 70% to 99% carotid stenosis in asymptomatic patients and 50% to 99% in symptomatic patients, per the NASCET index. Using a FilterWire EZ™ (Boston Scientific, Natick, MA, USA) embolic protection system (EPS), MicroNet-covered stent PCAS was performed by two interventional radiologists with at least 8 years of experience in endovascular intervention. Each patient underwent post-dilatation following stent placement. Finally, a third radiologist (not participating in the interventional procedures) evaluated the cone beam CT scans and calculated residual stenosis. Major and minor complications were recorded in the 30 days following the procedure. RESULTS: A total of 192 patients (121 male, mean age 73±10 years) were included in the study, and all patients received post-dilatation following stent implantation. Technical successes were achieved in all procedures. Adverse events noted in this study were limited to periprocedural transient ischemic attacks that occurred in three out of 192 patients (1.6%) and showed a swift complete recovery. The post-dilatation balloon diameters used in the study were: 5.0 mm (30.3%), 5.5 mm (39.3%) and 6 mm (30.3%). Optimized postdilatation resulted in a significant increase in the final luminal area. Similar improvements were observed in all subtypes of plaque. CONCLUSIONS: Post-dilatation in protected CAS is safe and induces a significant improvement in the cross-sectional area regardless of the stenotic plaque.

The Diagnostic Value of the 12-Lead ECG in Arrhythmogenic Left Ventricular Cardiomyopathy: Novel ECG Signs.

BACKGROUND: Electrocardiographic (ECG) findings in arrhythmogenic left ventricular cardiomyopathy (ALVC) are limited to small case series. OBJECTIVES: This study aimed to analyze the ECG characteristics of ALVC patients and to correlate ECG with cardiac magnetic resonance and genotype data. METHODS: We reviewed data of 54 consecutive ALVC patients (32 men, age 39 ± 15 years) and compared them with 84 healthy controls with normal cardiac magnetic resonance. RESULTS: T-wave inversion was often noted (57.4%), particularly in the inferior and lateral leads. Low QRS voltages in limb leads were observed in 22.2% of patients. The following novel ECG findings were identified: left posterior fascicular block (LPFB) (20.4%), pathological Q waves (33.3%), and a prominent R-wave in V1 with a R/S ratio ≥0.5 (24.1%). The QRS voltages were lower in ALVC compared with controls, particularly in lead I and II. At receiver-operating characteristic analysis, the sum of the R-wave in I to II ≤8 mm (AUC: 0.909; P < 0.0001) and S-wave in V1 plus R-wave in V6 ≤12 mm (AUC: 0.784; P < 0.0001) effectively discriminated ALVC patients from controls. It is noteworthy that 4 of the 8 patients with an apparently normal ECG were recognized by these new signs. Transmural late gadolinium enhancement was associated to LPFB, a R/S ratio ≥0.5 in V1, and inferolateral T-wave inversion, and a ringlike pattern correlated to fragmented QRS, SV1+RV6 ≤12 mm, low QRS voltage, and desmoplakin alterations. CONCLUSIONS: Pathological Q waves, LPFB, and a prominent R-wave in V1 were common ECG signs in ALVC. An R-wave sum in I to II ≤8 mm and SV1+RV6 ≤12 mm were specific findings for ALVC phenotypes compared with controls.

Cardiac magnetic resonance-guided cardiac ablation: a case series of an early experience.

Radiofrequency (RF) catheter ablation has become a widely used therapeutic approach. However, long-term results in terms of arrhythmia recurrence are still suboptimal. Cardiac magnetic resonance (CMR) could offer a valuable tool to overcome this limitation, with the possibility of targeting the arrhythmic substrate and evaluating the location, depth, and possible gaps of RF lesions. Moreover, real-time CMR-guided procedures offer a radiation-free approach with an evaluation of anatomical structures, substrates, RF lesions, and possible complications during a single procedure. The first steps in the field have been made with cavotricuspid isthmus ablation, showing similar procedural duration and success rate to standard fluoroscopy-guided procedures, while allowing visualization of anatomic structures and RF lesions. These promising results open the path for further studies in the context of more complex arrhythmias, like atrial fibrillation and ventricular tachycardias. Of note, setting up an interventional CMR (iCMR) centre requires safety and technical standards, mostly related to the need for CMR-compatible equipment and medical staff's educational training. For the cardiac imagers, it is fundamental to provide correct CMR sequences for catheter tracking and guide RF delivery. At the same time, the electrophysiologist needs a rapid interpretation of CMR images during the procedures. The aim of this paper is first to review the logistic and technical aspects of setting up an iCMR suite. Then, we will describe the experience in iCMR-guided flutter ablations of two European centres, Policlinico Casilino in Rome, Italy, and Haga Teaching Hospital in The Hague, the Netherlands.

The electrocardiogram in non-ischaemic-dilated cardiomyopathy.

This article summarizes the main electrocardiogram (ECG) findings in dilated cardiomyopathy (DCM) patients. Recent reports are described in the great 'pot' of DCM peculiar ECG patterns that are typical of specific forms of DCM. Patients with late gadolinium enhancement on CMR, who are at greatest arrhythmic risk, have also distinctive ECG features. Future studies in large DCM populations should evaluate the diagnostic and prognostic value of the ECG.

Cardiac magnetic resonance in Fabry disease.

Fabry disease (FD) is a rare X-linked inherited lysosomal storage disorder caused by deficient a-galactosidase A activity that leads to an accumulation of glycolipids, mainly globotriaosylceramide (Gb3) and globotriaosylsphingosine, in affected tissues, including the heart. Cardiovascular involvement usually manifests as left ventricular hypertrophy (LVH), myocardial fibrosis, heart failure, and arrhythmias, which limit the quality of life and represent the most common causes of death. Following the introduction of enzyme replacement therapy, early diagnosis and treatment have become essential in slowing down the disease progression and preventing major cardiac complications. Recent advances in the understanding of FD pathophysiology suggest that in addition to Gb3 accumulation, other mechanisms contribute to the development of cardiac damage. FD cardiomyopathy is characterized by an earlier stage of glycosphingolipid accumulation and a later one of hypertrophy. Morphological and functional aspects are not specific in the echocardiographic evaluation of Anderson-Fabry disease. Cardiac magnetic resonance with tissue characterization capability is an accurate technique for the differential diagnosis of LVH. Progress in imaging techniques has improved the diagnosis and staging of FD-related cardiac disease: a decreased myocardial T1 value is specific of FD. Late gadolinium enhancement is typical of the later stage of cardiac involvement but as in other cardiomyopathy is also valuable to predict the outcome and cardiac response to therapy.

MR guided cardiac ablation: how to build an interventional magnetic resonance suite and what's the role of the imaging.

Magnetic resonance (MR) represents a new interesting imaging approach for guiding electrophysiology (EP)-based ablation procedures of atrial flutter and typical atrial fibrillation. This new approach permits to reach good results if compared with conventional EP ablation. Tissue characterization by MR permits to detect cardiac anatomy and pathological substrate like myocardial scars well visualized with late gadolinium enhancement (LGE) sequences. Intra-procedural imaging is useful to real-time follow the catheter during the ablation procedure and at the same time to visualize cardiac anatomy in addition to understanding if the ablation is correctly performed using oedema sequences. Performing cardiac ablations inside an MR room permits to reduce radiation exposure and occupational illnesses.

Electrocardiogram in arrhytmogenic cardiomyopathy.

Criteria for diagnosis of arrhythmogenic cardiomyopathy (ACM) were first proposed in 1994 and subsequently revised in 2010 and in 2020 by an international task force. According to the last consensus of 2020, ACM is defined as a heart muscle disease affecting right ventricle, left ventricle or both, whose principal pathologic feature is fibrofatty myocardial replacement that impairs systolic ventricular function and predisposes to lethal ventricular arrhythmias. ECG findings not only could help to early recognize affected patients but also could identify the ones with maximum risk of ventricular arrhythmias and sudden cardiac death.

Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study.

AIM: The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). MATERIALS AND METHODS: From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5-7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected. RESULTS: VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders (p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p: 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management. CONCLUSION: Our study suggests a better outcome with the same complication rate, except that for AVF incidence for non-balloon collagen plug device if compared to balloon occluders vascular closure devices.

MRI-guided thoraco-abdominal percutaneous needle biopsy: our initial experience.

OBJECTIVE: The aim of this study is to describe the technique and to report early results of thoraco-abdominal biopsies in the Interventional Magnetic Resonance Imaging Suite (IMRIS). MATERIALS AND METHODS: We prospectively evaluated patients with indications for MRI-guided biopsy between January 2021 and May 2022. Exclusion criteria were indication for US-/CT-guided biopsy, contraindication to percutaneous biopsy, inability to lie flat for at least 30 min, claustrophobic, severe obesity, or non-MRI compatible devices. Biopsies were performed by 3 interventional radiologists, with at least 8 years of experience in oncological interventional radiology. Epidemiological, clinical, procedural, and histopathological data were retrospectively collected. RESULTS: From an initial population of 117 patients, 57 patients (32 male, mean age 64 ± 8 y) were finally enrolled. All 57 patients suspected thoraco-abdominal malignant lesions finally underwent MRI-guided percutaneous biopsy. The mean duration of the entire procedure was 37 min (range 28-65 min); the mean duration of the total needle-in-patient time was 10 min (range 6-19 min). Technical and clinical success were obtained for all the biopsies performed. Malignancy was demonstrated in 47/57 (82%) cases and benignancy in the remaining 10/57 (18%) cases. No major complications were detected after the biopsies; two minor compliances (severe pain) occurred and were managed conservatively. CONCLUSION: Our initial experience demonstrated the technical feasibility and the accuracy of MRI-guided biopsies of thoraco-abdominal masses. The reported data associated with the best comfort for the patient and for the operator make the use of MRI a valid alternative to other methods, especially in lesions that are difficult to approach via US or CT. CLINICAL RELEVANCE STATEMENT: Interventional MRI is one of the most important innovations available for interventional radiologists. This method will broaden the diagnostic and therapeutic possibilities, allowing treatment of lesions up to now not approachable percutaneously. For this, it is necessary to start publishing the data of the few groups that are developing the method. KEY POINTS: • To evaluate the use of MRI as a guide for percutaneous biopsies of various districts. • Our preliminary experience confirms experience demonstrated the technical feasibility and the accuracy of MRI-guided biopsies of thoraco-abdominal masses. • Interventional MRI can become the reference method for percutaneous biopsies in particular for lesions with difficult percutaneous approach.

Predicting gene and protein expression levels from DNA and protein sequences with Perceiver.

BACKGROUND AND OBJECTIVE: The functions of an organism and its biological processes result from the expression of genes and proteins. Therefore quantifying and predicting mRNA and protein levels is a crucial aspect of scientific research. Concerning the prediction of mRNA levels, the available approaches use the sequence upstream and downstream of the Transcription Start Site (TSS) as input to neural networks. The State-of-the-art models (e.g., Xpresso and Basenjii) predict mRNA levels exploiting Convolutional (CNN) or Long Short Term Memory (LSTM) Networks. However, CNN prediction depends on convolutional kernel size, and LSTM suffers from capturing long-range dependencies in the sequence. Concerning the prediction of protein levels, as far as we know, there is no model for predicting protein levels by exploiting the gene or protein sequences. METHODS: Here, we exploit a new model type (called Perceiver) for mRNA and protein level prediction, exploiting a Transformer-based architecture with an attention module to attend to long-range interactions in the sequences. In addition, the Perceiver model overcomes the quadratic complexity of the standard Transformer architectures. This work's contributions are 1. DNAPerceiver model to predict mRNA levels from the sequence upstream and downstream of the TSS; 2. ProteinPerceiver model to predict protein levels from the protein sequence; 3. Protein&DNAPerceiver model to predict protein levels from TSS and protein sequences. RESULTS: The models are evaluated on cell lines, mice, glioblastoma, and lung cancer tissues. The results show the effectiveness of the Perceiver-type models in predicting mRNA and protein levels. CONCLUSIONS: This paper presents a Perceiver architecture for mRNA and protein level prediction. In the future, inserting regulatory and epigenetic information into the model could improve mRNA and protein level predictions. The source code is freely available at https://github.com/MatteoStefanini/DNAPerceiver.

Anatomical Modifications After Stent Implantation: A Comparative Analysis Between CGuard, Wallstent, and Roadsaver Carotid Stents.

PURPOSE: Carotid revascularization can be associated with modifications of the vascular geometry, which may lead to complications. The changes on the vessel angulation before and after a carotid WallStent (WS) implantation are compared against 2 new dual-layer devices, CGuard (CG) and RoadSaver (RS). MATERIALS AND METHODS: The study prospectively recruited 217 consecutive patients (112 GC, 73 WS, and 32 RS, respectively). Angiography projections were explored and the one having a higher arterial angle was selected as a basal view. After stent implantation, a stent control angiography was performed selecting the projection having the maximal angle. The same procedure is followed in all the 3 stent types to guarantee comparable conditions. The angulation changes on the stented segments were quantified from both angiographies. The statistical analysis quantitatively compared the pre-and post-angles for the 3 stent types. The results are qualitatively illustrated using boxplots. Finally, the relation between pre- and post-angles measurements is analyzed using linear regression. RESULTS: For CG, no statistical difference in the axial vessel geometry between the basal and postprocedural angles was found. For WS and RS, statistical difference was found between pre- and post-angles. The regression analysis shows that CG induces lower changes from the original curvature with respect to WS and RS. CONCLUSION: Based on our results, CG determines minor changes over the basal morphology than WS and RS stents. Hence, CG respects better the native vessel anatomy than the other stents.Level of Evidence: Level 4, Case Series.

From Show to Tell: A Survey on Deep Learning-Based Image Captioning.

Connecting Vision and Language plays an essential role in Generative Intelligence. For this reason, large research efforts have been devoted to image captioning, i.e. describing images with syntactically and semantically meaningful sentences. Starting from 2015 the task has generally been addressed with pipelines composed of a visual encoder and a language model for text generation. During these years, both components have evolved considerably through the exploitation of object regions, attributes, the introduction of multi-modal connections, fully-attentive approaches, and BERT-like early-fusion strategies. However, regardless of the impressive results, research in image captioning has not reached a conclusive answer yet. This work aims at providing a comprehensive overview of image captioning approaches, from visual encoding and text generation to training strategies, datasets, and evaluation metrics. In this respect, we quantitatively compare many relevant state-of-the-art approaches to identify the most impactful technical innovations in architectures and training strategies. Moreover, many variants of the problem and its open challenges are discussed. The final goal of this work is to serve as a tool for understanding the existing literature and highlighting the future directions for a research area where Computer Vision and Natural Language Processing can find an optimal synergy.

Carotid artery revascularization using second generation stents versus surgery: a meta-analysis of clinical outcomes.

INTRODUCTION: Meta-analyses and emerging randomized data indicate that second-generation ('mesh') carotid stents (SGS) may improve outcomes versus conventional (single-layer) stents but clinically-relevant differences in individual SGS-type performance have been identified. No comparisons exist for SGS versus carotid endarterectomy (CEA). EVIDENCE ACQUISITION: Thirty-day death (D), stroke (S), myocardial infarction (M), and 12-month ipsilateral stroke and restenosis in SGS studies were meta-analyzed (random effect model) against CEA outcomes. Eligible studies were identified through PubMed/EMBASE/COCHRANE. Forest plots were formed for absolute adverse evet risk in individual studies and for relative outcomes with each SGS deign versus contemporary CEA outcomes as reference. Meta-regression was performed to identify potential modifiers of treatment modality effect. EVIDENCE SYNTHESIS: Data were extracted from 103,642 patients in 25 studies (14 SGS-treated, 41% symptomatic; nine randomized controlled trial (RCT)-CEA-treated, 37% symptomatic; and two Vascular Quality Initiative (VQI)-CEA-treated, 23% symptomatic). Casper/Roadsaver and CGuard significantly reduced DSM versus RCT-CEA (-2.70% and -2.95%, P<0.001 for both) and versus VQI-CEA (-1.11% and -1.36%, P<0.001 for both). Gore stent 30-day DSM was similar to RCT-CEA (P=0.581) but increased against VQI-CEA (+2.38%, P=0.033). At 12 months, Casper/Roadsaver ipsilateral stroke rate was lower than RCT-CEA (-0.75%, P=0.026) and similar to VQI-CEA (P=0.584). Restenosis with Casper/Roadsaver was +4.18% vs. RCT-CEA and +4.83% vs. VQI-CEA (P=0.005, P<0.001). CGuard 12-month ipsilateral stroke rate was similar to VQI-CEA (P=0.850) and reduced versus RCT-CEA (-0.63%, P=0.030); restenosis was reduced respectively by -0.26% and -0.63% (P=0.033, P<0.001). Twelve-month Gore stent outcomes were overall inferior to surgery. CONCLUSIONS: Meta-analytic integration of available clinical data indicates: 1) reduction in stroke but increased restenosis rate with Casper/Roadsaver, and 2) reduction in both stroke and restenosis with CGuard MicroNET-covered stent against contemporary CEA outcomes at 30 days and 12 months used as a reference. This may inform clinical practice in anticipation of large-scale randomized trials powered for low clinical event rates (PROSPERO-CRD42022339789).

Interventional Magnetic Resonance Imaging Suite (IMRIS): How to build and how to use.

Over the last ten years, the number of minimally invasive interventional procedures has been increasing steadily. Magnetic resonance imaging (MRI) is still far less frequently used for image-guided percutaneous procedures or as an intervention method than computed tomography (CT) and ultrasound (US). However, MRI has many advantages, such as lack of ionizing radiation, real-time MR-fluoroscopy placement high resolution, no bone and gas artifacts, the ability to display lesions that are difficult to observe on CT and US visualization of blood vessels without a contrast agent, free selection of imaging planes and in the case of procedures such as thermos or cryoablation it is possible to make an intraprocedural assessment of the process without the application of a contrasting agent (Marini et al. in Diagn Interv Imaging 102: 531-538, 2021; Li et al. in BMC Cancer 21: 366, 2021; Barkhausen et al. in Rofo 189: 611, 2017). Furthermore, in addition to its use in Interventional Radiology, MRI is also becoming a reality in cardiology thanks to the possibility of overcoming all the limits related to the fusion technology used up to now in cardiac ablations (Chubb et al. Arrhythm Electrophysiol Rev 6: 85, 2017). Some suites have been built in Northern Europe and in the United States, but based only on personal experience and industry indication. In our hospital, we have built a new Interventional Magnetic Resonance Imaging Suite (IMRIS), the first in Southern Europe and we have defined what the necessary requirements and equipment were for the safety of the patient and the operator.

Foot Revascularization Avoids Major Amputation in Persons with Diabetes and Ischaemic Foot Ulcers.

The study aims to evaluate the effectiveness of foot revascularization in persons with diabetic foot ulcers (DFUs) and below-the-ankle (BTA) arterial disease. Consecutive patients referred for a new active ischaemic DFU requiring lower limb revascularization were considered. Among those, only patients with a BTA arterial disease were included. Revascularization procedures were retrospectively analysed: in the case of successful foot revascularization (recanalization of pedal artery, or plantar arteries or both) or not, patients were respectively divided in two groups, successful foot perfusion (SFP) and failed foot perfusion (FFP). Healing, minor and major amputation at 12 months of follow-up were evaluated and compared. Eighty patients (80) were included. The mean age was 70.5 ± 10.9 years, 55 (68.7%) were male, 72 (90%) were affected by type 2 diabetes with a mean duration of 22.7 ± 11.3 years. Overall 45 (56.2%) patients healed, 47 (58.7%) had minor amputation and 13 (16.2%) major amputation. Outcomes for SFP and FFP were respectively: healing (89.3 vs. 9.1%, p < 0.0001), minor amputation (44.7 vs. 78.8%, p = 0.0001), major amputation (2.1 vs. 36.3%, p < 0.0001). Failed foot revascularization resulted an independent predictor of non-healing, minor amputation, and major amputation. Foot revascularization is mandatory to achieve healing and avoid major amputation in persons with ischaemic DFU and BTA arterial disease.

Harnessing the hERG1/ß1 Integrin Complex via a Novel Bispecific Single-chain Antibody: An Effective Strategy against Solid Cancers.

mAbs, either mono- or bispecific (bsAb), represent one of the most successful approaches to treat many types of malignancies. However, there are certain limitations to the use of full length mAbs for clinical applications, which can be overcome by engineered antibody fragments. The aim of this study was to develop a small bsAb, in the format of a single-chain diabody (scDb), to efficiently target two proteins, the hERG1 potassium channel and the ß1 subunit of integrin receptors, which specifically form a macromolecular complex in cancer cells. We provide evidence that the scDb we produced binds to the hERG1/ß1 complex in cancer cells and tissues, but does not bind to the hERG1 channel in nonpathologic tissues, in particular the heart. The scDb-hERG1-ß1 (i) downregulates the formation of the hERG1/ß1 complex, (ii) inhibits Akt phosphorylation and HIF-1α expression, and (iii) decreases cell survival, proliferation, and migration in vitro These effects only occur in cancer cells (either colon, pancreatic, or breast), but not in normal cells. In vivo, the scDb-hERG1-ß1 shows a good pharmacokinetic profile, with a half-life of 13.5 hours and no general, cardiac, or renal toxicity when injected intravenously up to the dose of 8 mg/kg. The scDb-hERG1-ß1 accumulates into subcutaneous xenografted tumors, arising from either colon or pancreatic human cancer cells, and induces a reduction of tumor growth and vascularization. Overall, the scDb-hERG1-ß1 represents an innovative single-chain bispecific antibody for therapeutic applications in solid cancers that overexpress the hERG1/ß1 integrin signaling complex.

Efficacy of Daptomycin-Containing Regimen for Treatment of Staphylococcal or Enterococcal Vertebral Osteomyelitis: A Prospective Clinical Experience.

Vertebral osteomyelitis (VO) is a compelling clinical entity for clinicians, because of its insidious and indolent course that makes diagnosis difficult. A concern is reported about the choice of antibiotic regimens, duration of therapy, and criteria to switch to oral therapy. We conducted a prospective observational study. All consecutive hospitalized patients with a confirmed diagnosis of VO caused by staphylococcal or enterococcal strains were analyzed. The primary endpoint was the analysis of clinical cure at the end of therapy. A propensity score for receiving therapy with daptomycin was added to the model. During the study period, 60 episodes of confirmed VO were observed. The main etiology of infection was methicillin-resistant Staphylococcus aureus (29%). Overall, clinical failure at end of therapy was reported in 11 (18.3%) patients. Logistic regression analysis, after propensity score, showed that >2 vertebrae involved (OR 2.4, CI95% 1.12-5.24, p = 0.002) and inadequate drainage of infection (OR 4.8, CI95% 2.45-8.51, p < 0.001) were independently associated with failure of therapy, while the use of a daptomycin-containing-regimen (OR 0.15, CI 95% 0.04-0.46, p < 0.001) with clinical cure. VO caused by staphylococcal or enterococcal strains is associated with an important rate of clinical failure. Daptomycin-containing regimen was strongly associated with clinical cure. Considering that over 70% of VO etiology is caused by Gram-positive strains but the etiology of infection is obtained in about 75% of cases, these data may help physicians to choose the appropriate antibiotic regimen.