Fiberscope-Based Measurement of Coaptation Height for Intraoperative Assessment of Mitral Valve Repair.

BACKGROUND: Restoring adequate coaptation height is a key principle of mitral valve (MV) repair. This study aimed to evaluate the utility of fiberscope (FS) technology to assess MV coaptation height for intraoperative use. METHODS: Ex-vivo testing was performed on five adult porcine hearts. The left atrium (LA) was resected, and the left ventricle (LV) was pressurized retrograde to 27 ± 1mm Hg. An endoscope was inserted into the LV apex, centered under the MV orifice. An FS system (Milliscope II camera, LED light source, and 0.7 mm diameter × 15 cm long) 90° semirigid scope with 1.2 mm focal length) was mounted above the MV annulus in a custom alignment and measuring fixture. Three blinded measurements were taken at two locations on each MV, A2 and P2 segment, from the top of coaptation to the leaflet edge identified by the FS. Accurate positioning was verified using the LV endoscope. A control (metal rod of similar thickness) was used for comparison, with coaptation height recorded when the control was seen via the endoscope. RESULTS: Coaptation heights were similar for the control and FS methods across all hearts at A2 (11.6 ± 2.6 mm control vs 11.8 ± 2.2 mm FS) and P2 (13.3 ± 2.6 mm control vs 13.4 ± 2.9 mm FS) segments, with similar measurement variability (control SD 0.1-1.0 mm; FS SD 0.1-0.9 mm). One outlier was excluded from analysis (n = 19/20). The maximum absolute difference and percent error between measurement methods were less than 1.1 mm (median [IQR], 0.6 [0.3-0.9] mm) and less than 14% (4.1 [2.2-7.6]%). CONCLUSIONS: Utilization of a miniaturized FS enabled precise and accurate quantification of MV coaptation. This technique is promising for evaluating post-repair valve competence and coaptation height.

A systematic review of the quality of cardiovascular surgery studies that extracted data from the MAUDE database.

OBJECTIVE: To investigate opportunities and limitations of using the Manufacturer and User Facility Device Experience (MAUDE) database for cardiovascular surgery research, we analyzed the quality of studies having ever used MAUDE, in the field of cardiovascular surgery. METHODS: We systematically searched the Cochrane Library, PubMed, EMBASE, and Google Scholar for randomized and nonrandomized studies, from inception to July 2019. Two authors evaluated the quality of the retrieved observational studies, according to the National Institutes of Health quality assessment tool for either case series or cross-sectional studies. These tools quantify the quality of case series and cohorts/cross-sectional studies, respectively, with nine and 14 queries. RESULTS: Fifty-eight studies were included in the final qualitative review. Of 58 identified studies, 32 were case series, 8 were abstracts of case series, and 13 were reviews or case discussion with an included series from MAUDE. Also, five articles were cross-sectional studies. Of the 32 formal case series, 26 (81%) were found to have poor quality. The most common reasons for a poor quality designation included a lack of consecutive participants, undetermined comparability of participants, and undetermined follow-up adequacy. Only one out of five cross-sectional studies had fair quality; four others were evaluated as poor quality studies. CONCLUSIONS: Cardiovascular surgery studies using the MAUDE database, whether case series or cross-sectional design, are mostly of poor quality. Their low quality is partly caused by poor study design, but mainly by intrinsic limitations to the MAUDE database: cases recruited are not consecutive; patient characteristics are not detailed enough to allow a meaningful comparison of patient characteristics between different patient entries; outcome measures are unclear; there is a limited follow-up; and time-to-event data are lacking. We conclude that the quality of cardiovascular surgery publications that rely on data from MAUDE could be improved if investigators were to extract all relevant data points from MAUDE entries, then apply standard quality assessment tools in compiling and reporting the data. MAUDE might be improved if it used medical case report standards during the process of reporting and indexing adverse events. To calculate the incidence rate of any adverse event, all event-free cases, as well as all adverse events in patients using a device, are required. Neither of these two variables is available in the MAUDE at the time of writing.

Epicardial left atrial appendage occlusion with a new medical device: assessment of procedural feasibility, safety and efficacy in a large animal model.

BACKGROUND: Left atrial appendage occlusion (LAAO) represents a treatment alternative to anticoagulation in patients with atrial fibrillation. We evaluate a novel device for epicardial LAAO in a translational canine model. METHODS: Nine hounds (n = 9) were used to assess usability, safety, and efficacy of the TigerPaw Pro (TPP) device for epicardial LAAO. Following baseline imaging (intra-cardiac echocardiography (ICE) and angiography) and intraoperative visual inspection, usability was tested via a ``closure/re-opening`` maneuver followed by deployment of a total of twenty TPP devices (n = 20) on the left and right atrial appendages respectively. Procedural safety was evaluated by assessing for adverse-events via direct Epicardial inspection and endocardial imaging. Efficacy evaluation included assessment of device positioning, presence of residual stumps and completeness of closure. Post-mortem evaluation was performed to confirm safety and efficacy. RESULTS: Usability testing of all TPP devices was successful (n = 20;100%, delivery-time range 22-120 s) without any procedural adverse-events (tissue damage or tears, bleeding, vessel-impingement, structural impact). All devices fully traversed the ostium (n = 18) or appendage body (n = 2), and conformed smoothly to adjacent cardiac anatomy. In nineteen deployments (n = 19;95%), all device connector pairs were fully engaged, while in one TPP device the most distal pair remained unengaged. ICE and post-mortem inspections revealed complete closure of all appendage ostia (n = 18;100%) and only in one case a small residual stump was detected. Intraoperative safety findings were further confirmed post-mortem. Devices created a nearly smooth line of closure via symmetric endocardial tissue-coaptation. CONCLUSIONS: In this preclinical model, the TPP demonstrated good ease of use for ostial access, ability to re-position (after engagement) and rapid deployment, while achieving safe and effective LAAO.

Left atrial appendage closure with the Watchman device using intracardiac vs transesophageal echocardiography: Procedural and cost considerations.

BACKGROUND: Imaging guidance for left atrial appendage (LAA) closure (LAAC) conventionally consists of transesophageal echocardiography (TEE) and fluoroscopy under general anesthesia (GA). Intracardiac echocardiography (ICE) can eliminate the need for GA, expedite procedural logistics, and reduce the patient experience to a simple venous puncture. OBJECTIVE: The purpose of this study was to define optimal ICE views and compare procedural parameters and cost of ICE vs TEE during LAAC with the Watchman device. METHODS: Optimal ICE views of the LAA for Watchman implant were delineated using Carto-Sound and 3-dimensional rendition of the LAA in 6 patients. Procedural and financial parameters of 104 consecutive patients with standard indications for LAAC undergoing Watchman implant using ICE guidance through a single transseptal puncture (n = 53 [51%]) were compared with those of TEE-guided implants (n = 51 [49%]) in 3 centers. RESULTS: Clinical characteristics were similar between the 2 groups. Total in-room, turnaround, and fluoroscopy times all were shorter using ICE (P <.05) under local anesthesia compared to the TEE group. Implant success was 100% in both groups without peri-device leaks or procedural complications. Follow-up TEE showed no significant peri-device leak in both groups. Total hospital charges for ICE with local anesthesia vs TEE were similar, as were total hospital direct and indirect costs. Professional fees were significantly lower with ICE and local anesthesia than with TEE because the charge of anesthesia staff was avoided. CONCLUSION: ICE-guided Watchman implant is safe, feasible, and comparable in cost to TEE during LAAC with a Watchman device but avoids GA and expedites procedure turnaround.

Blood Transfusion: Cost, Quality, and Other Considerations for the Surgical Management of the Critically Ill.

This article explores the average overall costs of blood transfusion for critically ill surgical patients and in particular explores the evidence supporting reduction of transfusion as part of guideline-based care in cardiothoracic surgical patients. Average cost data compiled from various sources are presented and quality and outcome considerations in blood transfusion in the critically ill are reviewed. Multiple strategies that have a high level of evidence to support their use in this population are noted.

Assessment of the usefulness of bacterial cellulose produced by Gluconacetobacter xylinus E25 as a new biological implant.

Bionanocellulose (BNC) is a clear polymer produced by the bacterium Gluconacetobacter xylinus. In our current study, "Research on the use of bacterial nanocellulose (BNC) in regenerative medicine as a function of the biological implants in cardiac and vascular surgery", we carried out material analysis, biochemical analysis, in vitro tests and in vivo animal model testing. In stage 1 of the project, we carried out physical and biological tests of BNC. This allowed us to modify subsequent samples of bacterial bionanocellulose. Finally, we obtained a sample that was accepted for testing on an animal model. That sample we define BNC1. Patches of BNC1 were then implanted into pigs' vessel walls. During the surgical procedures, we evaluated the technical aspects of sewing in the bioimplant, paying special attention to bleeding control and tightness of the suture line and the BNC1 bioimplant itself. We carried out studies evaluating the reaction of an animal body to an implantation of BNC1 into the circulatory system, including the general and local inflammatory reaction to the bioimplant. These studies allowed us to document the potential usefulness of BNC as a biological implant of the circulatory system and allowed for additional modifications of the BNC to improve the properties of this new implantable biological material.

The Value of Claims-Based Nontraditional Risk Factors in Predicting Long-term Mortality After MitraClip Procedure.

BACKGROUND: We sought to identify nontraditional risk factors coded in administrative claims data and evaluate their ability to improve prediction of long-term mortality in patients undergoing percutaneous mitral valve repair. METHODS: Patients undergoing transcatheter mitral valve repair using MitraClip implantation between September 28, 2010, and September 30, 2015 were identified among Medicare fee-for-service beneficiaries. We used nested Cox regression models to identify claims codes predictive of long-term mortality. Four groups of variables were introduced sequentially: cardiac and noncardiac risk factors, presentation characteristics, and nontraditional risk factors. RESULTS: A total of 3782 patients from 280 clinical sites received treatment with MitraClip over the study period. During the follow-up period, 1114 (29.5%) patients died with a median follow-up time period of 13.6 (9.6 to 17.3) months. The discrimination of a model to predict long-term mortality including only cardiac risk factors was 0.58 (0.55 to 0.60). Model discrimination improved with the addition of noncardiac risk factors (c = 0.63, 0.61 to 0.65; integrated discrimination improvement [IDI] = 0.038, P < 0.001), and with the subsequent addition of presentation characteristics (c = 0.67, 0.65 to 0.69; IDI = 0.033, P < 0.001 compared with the second model). Finally, the addition of nontraditional risk factors significantly improved model discrimination (c = 0.70, 0.68 to 0.72; IDI = 0.019, P < 0.001, compared with the third model). CONCLUSIONS: Risk-prediction models, which include nontraditional risk factors as identified in claims data, can be used to predict long-term mortality risk more accurately in patients who have undergone MitraClip procedures.

Level of Evidence in Economic Evaluations of Left Atrial Appendage Closure Devices: A Systematic Review.

OBJECTIVES: The objective of the present work was to assess the level of evidence in economic evaluations of percutaneous left atrial appendage closure devices, and to test the complementarity of three different tools for assessing the quality of economic evaluations. METHODS: We conducted a systematic review of articles in English or French listed in MEDLINE, Embase, Cochrane, the Cost-Effectiveness Analysis registry and the National Health Service Economic Evaluation Database. We included only economic evaluations concerning left atrial appendage closure devices. Data were extracted from articles by two authors working independently and using three analysis grids to measure the quality of economic evaluations [the British Medical Journal (BMJ) checklist, the hierarchy scale developed by Cooper et al. (J Health Serv Res Policy 10:245-50, 2005) and the Quality of Health Economic Studies (QHES) instrument]. RESULTS: Seven economic evaluations met our inclusion criteria. All were published between 2013 and 2016. All were cost-utility analyses, and fully complied with the BMJ checklist. According to the hierarchy scale developed by Cooper et al., the quality of data used was heterogeneous. Finally, the mean score for the seven economic studies was 90/100 with the QHES instrument. CONCLUSIONS: Despite the recent development of left atrial appendage closure devices, most economic evaluations conducted here were well-designed studies. Furthermore, different tools used to assess the quality of these studies were complementary, but none gave a global vision of the quality of economic studies.

Survival analysis of hierarchical learning curves in assessment of cardiac device and procedural safety.

Many Americans rely on cardiac surgical procedures and devices such as pacemakers and thrombolytic catheters to treat or manage their cardiovascular diseases. However, the failure of these cardiac devices and procedures could have grave consequences. One reason cardiac devices tended to fail was due to physician error; there is a learning effect for the physician or operator to come up to speed in skillfully implanting devices and conducting procedures. In order to better understand these learning effects, we had previously modeled the resulting learning curve effects in simulations a hierarchical setting with physicians clustered within institutions using our unique methodology (see the work of Govindarajulu et al 2017). Previously, we had employed these in hierarchical linear modeling and also in generalized estimating equations. In this setting, we have demonstrated how to apply similar methodology but revised in a survival analytic framework or time-to-event analyses. Through simulations and real dataset applications, we found that, out of the three shapes modeled to fit the learning curve, the logarithmic shape tended to have the best fit, similar to previous work (see the work of Govindarajulu et al 2017). However, as seen before, modeling the learning rate can be dataset specific and one shape may be better than another. We learned that modeling the learning rate could also be applied in the survival analysis setting through this new methodology. The goal of this paper is to model cardiac device and procedure learning curve effects in a time-to-event setting so that this knowledge may allow for the improvement of both short and long-term patient survival.

Economic assessment of traditional surgical intervention versus use of a new innovative radiofrequency based surgical system in device replacements.

INTRODUCTION: Intra-operative complications like mechanical damages to the leads, infections and hematomas during generator replacements of implantable pacemakers and defibrillators contribute to additional costs for hospitals. The aim of this study was to evaluate operation room use, costs and budget impact of generator replacements using either a traditional surgical intervention (TSI) with scissors, scalpel and electrocautery vs. a new radiofrequency energy based surgical system, called PEAK PlasmaBladeTM (PPB). MATERIALS AND METHODS: We conducted a retrospective analysis of a population including 508 patients with TSI and 254 patients with PPB who underwent generator replacement at the Kepler University Hospital in Linz or the St. Josef Hospital in Braunau, Austria. The economic analysis included costs of resources used for intra-operative complications (lead damages) and of procedure time for TSI vs. PPB. RESULTS: Proportion of males, mean age and type of generator replaced were similar between the two groups. Lead damages occurred significantly more frequent with TSI than with PPB (5.3% and 0.4%; p< 0.001) and the procedure time was significantly longer with TSI than with PPB (47.9±24.9 and 34.1±18.1 minutes; p<0.001). Shorter procedure time and a lower rate of lead damages with PPB resulted in per patient cost savings of €81. Based on estimated 2,700 patients annually undergoing generator replacement in Austria, the use of PPB may translate into cost savings of €219,600 and 621 saved operating facility hours. CONCLUSION: PPB has the potential to minimize the risk of lead damage with more efficient utilization of the operating room. Along with cost savings and improved quality of care, hospitals may use the saved operating room hours to increase the number of daily surgeries.

Cost-effectiveness analysis of a sealing hemostat patch (HEMOPATCH) vs standard of care in cardiac surgery.

BACKGROUND: A recent randomized controlled trial showed that patients undergoing ascending aorta surgery treated with HEMOPATCH to control bleeding had a significantly better hemostasis success rate than with dry or wet gauze compression or similar standard of care (SOC). OBJECTIVE: To compare the cost-effectiveness using two different agents for hemostasis (HEMOPATCH vs dry or wet gauze compression or similar SOC) in cardiac surgery from the European hospital perspective. METHODS: A literature-based cost-effectiveness model estimating average cost per successful hemostasis event was developed based on the hemostasis efficacy difference (HEMOPATCH = 97.6%, SOC = 65.8%, p < .001). Additional clinically significant end-points studied in the trial (blood transfusions and surgical revisions) were also analyzed. It was assumed that each surgery utilized two units of HEMOPATCH (dimensions of 4.5 × 9 cm) and two units of SOC. Product acquisition costs for HEMOPATCH and SOC were included along with outcome-related costs derived from the literature and inflation-adjusted to 2017 EUR and GBP. Results are presented for an average hospital with an annual case load of 574 cardiac surgeries. One-way and probabilistic sensitivity analyses were performed. RESULTS: Considering only product acquisition cost, HEMOPATCH had an incremental cost-effectiveness ratio (ICER) of €1,659, €1,519, €1,623, and £1,725 per hemostasis success when compared to SOC for Italy, Spain, France, and the UK, respectively. However, when considering the cost and potential difference in the frequency of transfusions and revisions compared to SOC, the use of HEMOPATCH was associated with an annual reduction of six revisions and 60 transfusions, improving the ICER to €1,440, €1,222, €1,461, and £1,592, respectively. Sensitivity analysis demonstrated model robustness. CONCLUSIONS: This analysis supports the use of HEMOPATCH over SOC in cardiac surgery in European hospitals to improve hemostasis success rates and potential cost offsets from reduced transfusions, complications, and surgical revisions.

3D transesophageal echocardiography: A new imaging tool for assessment of mitral regurgitation and for guiding percutaneous edge-to-edge mitral valve repair.

Real time three dimensional transesophageal echocardiography (3D TEE) is probably the most powerful and convincing imaging method for understanding the complicated multiform morphology and for evaluating geometry, dynamics and function of degenerative and functional mitral valve (MV) regurgitation. Moreover, color Doppler 3D TEE has been valuable to identify the location of the regurgitant orifice and the severity of the mitral regurgitation. 3D TEE has been shown to be of enormous value in helping surgeons to perform MV repair. In addition, due to its ability to show a "panoramic" view of the "theater" where the procedure takes place, it has become an indispensable companion of 2D TEE during percutaneous edge-to-edge repair. A novel hybrid imaging modality where echocardiography is merged with fluoroscopy, may in the future further improve guidance of this and other complex percutaneous transcatheter interventions.

Improved Algorithm for Ostium Size Assessment in Watchman Left Atrial Appendage Occlusion Using Three-Dimensional Echocardiography.

AIMS: Correct sizing of the ostium is a crucial step in left atrial appendage (LAA) occlusion procedures. However, unfavorable anatomy of the ostium often complicates the assessment of the true ostium diameter. We hypothesized that area-derived diameter (ADD) and perimeter-derived diameter (PDD) from three-dimensional transesophageal echocardiogram (3D-TEE) can facilitate this step of the procedure as compared with two-dimensional (2D) measurements. METHODS AND RESULTS: For 55 patients within the ALSTER-LAA registry, retrospective analysis of PDD and ADD was correlated with 2D measurements used during the procedure to ascertain correct size of the Watchman device (Boston Scientific). The observed data were put into relation to the calculated area of the device with 10%-30% compression and the clinical outcome after 30 days. 3D area and perimeter measurements of the LAA ostium matched the calculated range of the different device sizes. Recapture during implantation, gaps <5 mm, and device size changes were more often observed when ADDs would also have suggested the use of a larger device. CONCLUSION: 3D ADDs and PDDs are feasible to use in device size decisions. Employing these measurements may allow operators to further reduce intraprocedural recapture maneuvers, peridevice leakage, and device size changes.

Quantification of mitral regurgitation during percutaneous mitral valve repair: added value of simultaneous hemodynamic and 3D echocardiographic assessment.

The objective of this study was to investigate the usefulness of intraprocedural hemodynamic monitoring for MR evaluation during pMRV. Assessment of mitral regurgitation (MR) during percutaneous mitral valve repair (pMVR) procedure is challenging. 3D color Doppler allows exact quantification of MR, but is technically demanding. Sixty patients with moderate to severe MR (14 with structural and 46 functional MR) were included in the study. Intraprocedural pressure curves were continuously obtained in the left atrium (LA) and left ventricle (LV). Transesophageal echocardiography was performed using 3D color Doppler derived mean vena contracta area (VCAmean) and mitral regurgitation volume (RegVol) to quantify MR severity before and after each clip implantation. In the entire patient group, strongest correlations were observed firstly between VCA and the raise of the ascending limb of the left atrial V pressure wave (Vascend; r = 0.58, p < 0.001) and secondly between the difference of peak V wave pressure and mean LA pressure divided by systolic LV pressure [(Vpeak - LAmean) - LVsystole; r = 0.53, p < 0.001]. In patients with structural MR, the highest area under the ROC curve for prediction of mild MR (VCAmean < 0.2 cm² and RegVol < 30 ml) after clip implantation was found for Vascend (AUC 0.89, p < 0.001) whereas in functional MR calculation of (Vpeak - LAmean) - LVsystole showed the highest predictive value (AUC 0.69, p = 0.003). Invasive pressure monitoring can give a direct feedback with regard to the success of clip placement during pMVR.

Mycobacterium chimaera Infections Associated With Contaminated Heater-Cooler Devices for Cardiac Surgery: Outbreak Management.

The global outbreak of Mycobacterium chimaera infections associated with heater-cooler devices (HCDs) presents several important, unique challenges for the infection prevention community. The primary focus of this article is to assist hospitals in establishing a rapid response for identification, notification, and evaluation of exposed patients, and management of HCDs with regard to placement and containment, environmental culturing, and disinfection.

Cost effectiveness of left atrial appendage closure with the Watchman device for atrial fibrillation patients with absolute contraindications to warfarin.

AIMS: Atrial fibrillation (AF) patients with contraindications to oral anticoagulation have had few options for stroke prevention. Recently, a novel oral anticoagulant, apixaban, and percutaneous left atrial appendage closure (LAAC) have emerged as safe and effective therapies for stroke risk reduction in these patients. This analysis assessed the cost effectiveness of LAAC with the Watchman device relative to apixaban and aspirin therapy in patients with non-valvular AF and contraindications to warfarin therapy. METHODS AND RESULTS: A cost-effectiveness model was constructed using data from three studies on stroke prevention in patients with contraindications: the ASAP study evaluating the Watchman device, the ACTIVE A trial of aspirin and clopidogrel, and the AVERROES trial evaluating apixaban. The cost-effectiveness analysis was conducted from a German healthcare payer perspective over a 20-year time horizon. Left atrial appendage closure yielded more quality-adjusted life years (QALYs) than aspirin and apixaban by 2 and 4 years, respectively. At 5 years, LAAC was cost effective compared with aspirin with an incremental cost-effectiveness ratio (ICER) of €16 971. Left atrial appendage closure was cost effective compared with apixaban at 7 years with an ICER of €9040. Left atrial appendage closure was cost saving and more effective than aspirin and apixaban at 8 years and remained so throughout the 20-year time horizon. CONCLUSIONS: This analysis demonstrates that LAAC with the Watchman device is a cost-effective and cost-saving solution for stroke risk reduction in patients with non-valvular AF who are at risk for stroke but have contraindications to warfarin.

Transcatheter Versus Surgical Closure of Atrial Septal Defects in Children: A Value Comparison.

OBJECTIVES: The purpose of this study was to determine whether a transcatheter procedure or surgical closure offers a better value proposition for atrial septal defect (ASD) closure. BACKGROUND: Secundum ASDs are common congenital heart defects with both transcatheter and surgical treatment options. Although both options have been shown to have excellent results in children, the relative value of the 2 procedures is unclear. METHODS: Using data from the Pediatric Hospital Information System for 2004 to 2012, we compared the value of transcatheter versus surgical ASD closure for children ages 1 to 17 years, with value being defined as outcomes relative to costs. Total charges for procedure-related encounters were converted to costs using hospital-specific cost-to-charge ratios, and all costs were adjusted for inflation to reflect 2012 dollars. RESULTS: There were 4,606 transcatheter procedures and 3,159 surgeries at 35 children's hospitals. Those undergoing transcatheter closure were more likely to be older (5.6 years vs. 4.5 years, p < 0.0001). There was no mortality in either group. Children with a surgical procedure had a longer length of stay (4.0 days vs. 1.5 days, p < 0.0001), were more likely to have an infection (odds ratio: 3.73, p < 0.0001) or procedural complication (odds ratio: 6.66, p < 0.0001). Costs for transcatheter procedure encounters were lower than costs for surgical encounters (mean of $19,128 vs. $25,359, p < 0.0001). CONCLUSIONS: Both transcatheter and surgical ASD closure had excellent short-term outcomes, but transcatheter procedures had lower lengths of stay, rates of infection, and complications, resulting in lower overall costs. For children who are eligible, transcatheter ASD closure provides better short-term value than surgery.

Recent Developments in Minimally Invasive Cardiac Surgery: Evolution or Revolution?

Intraluminal aortic clamping has been achieved until now by means of a sophisticated device consisting of a three-lumen catheter named Endoclamp, which allows at the same time occlusion of the aorta, antegrade delivering of cardioplegia, and venting through the aortic root. This tool has shown important advantages allowing aortic occlusion and perfusate delivering without a direct contact with ascending aorta reducing meanwhile the risk of traumatic and/or iatrogenic injuries. Recently, a new device (Intraclude catheter) with the same characteristics and properties has been proposed and introduced in clinical practice. The aim of this paper is to investigate the differences between Endoclamp and Intraclude catheters and to analyze the advantages advocated by this new device for intraluminal aortic occlusion since it is noticeable as these new technological tools are gaining more and more attractiveness due to their appraised clinical efficacy.

Transareolar Robotic-Assisted Access to the Mitral Valve.

During the past years, a rapid development and refinements of robotic heart valve techniques have led to consider robotic mitral valve (MV) surgery safe, effective, and durable. Robotic MV surgery has proven to be a cost-effective and cost-saving strategy in MV operations, being associated with reduced morbidity and mortality rates. We present a novel video-assisted transareolar approach to access the MV using the da Vinci Si HD telemanipulation system (Intuitive Surgical, Inc, Sunnyvale, CA USA). This technique is effective and reproducible, providing maximum patient satisfaction from both the clinical and cosmetic points of view.

Comparison of Efficacy and Cost of Iodine Impregnated Drape vs. Standard Drape in Cardiac Surgery: Study in 5100 Patients.

We sought to examine the efficacy in preventing surgical site infection (SSI) in cardiac surgery, using two different incise drapes (not iodine-impregnated and iodine-impregnated). A cost analysis was also considered. Between January 2008 and March 2015, 5100 consecutive cardiac surgery patients, who underwent surgery in our Institute, were prospectively collected. A total of 3320 patients received a standard not iodine-impregnated steri-drape (group A), and 1780 patients received Ioban(®) 2 drape (group B). We investigated, by a propensity matched analysis, whether the use of standard incise drape or iodine-impregnated drape would impact upon SSI rate. Totally, 808 patients for each group were matched for the available risk factors. Overall incidence of SSI was significantly higher in group A (6.5 versus 1.9 %) (p = 0.001). Superficial SSI incidence was significantly higher in group A (5.1 vs 1.6 %) (p = 0.002). Deep SSI resulted higher in group A (1.4 %) than in group B (0.4 %), although not significantly (p = 0.11). Consequently, the need for vacuum-assisted closure (VAC) therapy use resulted 4.3 % in group A versus 1.2 % in group B (p = 0.001). Overall costs for groups A and B were 12.494.912 € and 11.721.417 €, respectively. The Ioban(®) 2 offered totally 773.495 € cost savings compared to standard steri-drape. Ioban 2 drape assured a significantly lower incidence of SSI. Additionally, Ioban(®) 2 drape proved to be cost-effective in cardiac surgery.