Post-implantation Complications Research Articles

Five-year outcomes following left ventricular assist device implantation in England

ObjectiveImplant rates of mechanical circulatory supports such as left ventricular assist devices (LVAD) have steadily increased in the last decade. We assessed the utility of administrative data to provide information...

Early Post-Operative Hyperlactatemia as a Prognostic Indicator for Left Ventricular Assist Device Implantation

<h3>Purpose</h3> This study evaluated the impact of early post-operative hyperlactatemia on outcomes after left ventricular assist device (LVAD) implantation. <h3>Methods</h3> Adults undergoing contemporary LVAD implantation (HeartMate 3 or HeartWare HVAD) between 2009 to 2018 were included. Peak post-operative (within 24-hours) lactate level was analyzed. The cohort was stratified into patients with and without post-op hyperlactatemia, which was defined as peak >3.5 mMol/L. The primary outcome was survival, and secondary outcomes included post-implant adverse events. Sub-analysis was performed to evaluate the impact of hours for lactate normalization, define as lactate <2 mMol/L. Multivariable cox regression was used for risk-adjustment. <h3>Results</h3> 190 patients were included. 49.5% experienced post-operative hyperlactatemia. Patients with post-operative hyperlactatemia had significantly higher rates of post-implant complications including re-operation, renal failure, and hepatic dysfunction (all, p≤0.05). The post-operative hyperlactatemia group also had significantly higher 90-days and 1-year mortality rates following LVAD implantation (all, p≤0.05) (<b>Table</b>). In multivariable analysis, post-operative hyperlactatemia (HR 1.69, 95% CI 1.09-2.60, p=0.02) was an independent predictor of overall mortality following LVAD implantation. Increased time for normalization of lactate also adversely impacted risk-adjusted overall mortality following implantation as a continuous variable (HR 1.02, 95% CI 1.01-1.03, p<.001). <h3>Conclusion</h3> This study demonstrates post-operative hyperlactatemia is associated with increased morbidity and mortality following LVAD implantation. Even early post-operative lactate trends within the first 24 postoperative hours appear to have useful role in predicting longitudinal survival following implantation. Careful monitoring of post-operative lactate with measures to normalize levels should be considered in the early care of LVAD patients.

Optimization Prior to Left Ventricular Assist Device Implantation is Associated with Reduced Risk of Severe Early Post-Implant Complications

<h3>Purpose</h3> Although hemodynamic status prior to continuous flow left ventricular assist device placement (CF-LVAD) is an important determinant of outcomes, data on pre-implant optimization and patient-oriented outcomes are sparse. <h3>Methods</h3> We identified consecutive patients undergoing CF-LVAD implant between 2007 and 2017 at a single institution. Hemodynamic variables at three time points and laboratory studies were evaluated pre-LVAD implant in a logistic regression model to identify predictors of the primary composite endpoint: need for right ventricular assist device (RVAD) therapy, requirement for hemodialysis at 90 days, and 30-day mortality. <h3>Results</h3> Multivariate modeling identified three variables significantly associated with the primary endpoint: right ventricular stroke work index (RVSWI), right atrial pressure (RAP), and blood urea nitrogen (BUN); all immediately pre-LVAD, <i>P</i><.01. Optimal dichotomization points (rounded) were 500 mmHg*ml*m⁻², 12 mmHg, and 40 mg/dL, respectively. The three-component model identified an AUC of 0.77 (<i>P</i><.0001) for the composite endpoint. Optimization of 2/3 parameters, 1/3, and 0/3 was associated with of odds ratios of 2.4 (95% CI 0.8-7.6), 5.5 (1.8-17.0), and 18.9 (4.9-73.1), respectively, for the primary endpoint relative to those patients who were fully optimized (3/3 parameters). Number of optimized parameters was also associated with 1-year overall survival (<i>P</i>=.02). <h3>Conclusion</h3> Low RVSWI, high RAP, and high BUN were independently associated with adverse outcomes after CF-LVAD implant, and demonstrated a stepwise association with severe post-implant adverse events. Prospective, protocol-driven hemodynamic optimization should be tested to improve outcomes after CF-LVAD implantation.

Implant pénien pour dysfonction érectile chez le patient neurologique, indication, complications et satisfaction : étude rétrospective sur 27 patients

Penile prosthesis for erectile dysfunction in patients with spinal cord injury or multiple sclerosis is sometimes discussed after failure of drug or instrumental treatments (vacuum). The objective of this study was to evaluate the complications, evolution and patient satisfaction after the implantation of a penile prosthesis in the neurological patient. Multi-center retrospective study of 27consecutive patients including 18spinal cord injured patients and 9patients with multiple sclerosis benefiting from the implantation of a penile prosthesis for erectile dysfunction purposes in two French centers between 2009and 2019. Post-implantation complications, evolution of the use of the prosthesis and global patient satisfaction were evaluated using the standardized questionnaire Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) during a telephone call between March and May 2020. The average age of implantation was 46.4years (±12.74). The length of follow-up to date of call was 6.05years (±2.86). 8/27patients (29.6%) had at least one complication of any Clavien-Dindo grade included 2infection. 2/27 (7,4%) patients had a mechanical prosthesis injury during follow-up. The patient's dexterity with inflation of the prosthesis was perfect in 85% of cases, and 75% for deflation. The satisfaction rate for prosthesis use at the time of the call was 75.36/100pts for the patient and 66.88/100pts for the partner. This study found an increased rate of prothesis infection compared to the general population in the neurologic patient, but patient and partner satisfaction remain sustainable after more than 5years of implantation. Dexterity was maintained over the long term, demonstrating a good selection of indications. These data invite to favorably consider the installation of a penile prosthesis in neurological patients who have failed first-line treatments. 4.

Biocompatibility and Antibacterial Properties of ZnO-Incorporated Anodic Oxide Coatings on TiZrNb Alloy.

In a present paper, we demonstrate novel approach to form ceramic coatings with incorporated ZnO nanoparticles (NPs) on low modulus TiZrNb alloy with enhanced biocompatibility and antibacterial parameters. Plasma Electrolytic Oxidation (PEO) was used to integrate ZnO nanoparticles (average size 12–27 nm), mixed with Ca(H2PO2)2 aqueous solution into low modulus TiZrNb alloy surface. The TiZrNb alloys with integrated ZnO NPs successfully showed higher surface porosity and contact angle. XPS investigations showed presence of Ca ions and absence of phosphate ions in the PEO modified layer, what explains higher values of contact angle. Cell culture experiment (U2OS type) confirmed that the surface of as formed oxide-ZnO NPs demonstrated hydrophobic properties, what can affect primary cell attachment. Further investigations showed that Ca ions in the PEO coating stimulated proliferative activity of attached cells, resulting in competitive adhesion between cells and bacteria in clinical situation. Thus, high contact angle and integrated ZnO NPs prevent bacterial adhesion and considerably enhance the antibacterial property of TiZrNb alloys. A new anodic oxide coating with ZnO NPs could be successfully used for modification of low modulus alloys to decrease post-implantation complications.

Left Ventricular Assist Device-Related Complications

Abstract Left ventricular assist device (LVAD) has emerged as a safe, durable, and revolutionary therapy for end-stage heart failure patients. Despite the appearance of newer-generation devices that have improved patient outcomes, the burden of adverse events remains significant. Although the survival rate for patients with LVAD is appreciated to be 81% at 1 year and 70% at 2 years, the incidence of adverse events is also high. Over time, both early and late postimplant complications have diminished in terms of prevalence and impact; however, complications, such as infections, bleeding, right heart failure, pump thrombosis, aortic insufficiency, or stroke, continue to represent a challenge for the practitioner. Therefore, the aim of this review is to highlight the most recent data regarding the current use of LVAD in the treatment of end-stage heart failure, with a specific focus on LVAD-related complications, in order to improve device-related outcomes. It will also revise how to mitigate the risk and how to approach specific adverse events. Withal, understanding the predisposing risk factors associated with postimplant complications, early recognition and appropriate treatment help to significantly improve the prognosis for patients with end-stage heart failure.

Azygos Vein Dissection during Pacemaker Electrode Lead Insertion: A Case Report

The invention of pacemakers has saved lives and improved the quality of life of countless patients. As the number of implantations has increased, so has the number of cases of post-implantation complications. To improve the ability to identify the complications of cardiac pacemaker insertion, it is necessary to remember that any type of intervention, however small, requires constant caution to achieve optimal surgical safety, minimal intraoperative risk, and individualized surgical methods, all of which can reduce the risk of complications of cardiac pacemaker insertion and maximize therapeutic benefits.

Nanopatterned silk-coated AZ31 magnesium alloy with enhanced antibacterial and corrosion properties.

Because of unique properties such as the lightweight, natural biodegradability, and biocompatibility, magnesium alloys are promising in biomedical implants. However, inadequate corrosion resistance in the physiological environment remains a technical hurdle and application of coatings is a viable means to overcome the deficiency. Also, the antibacterial properties are very important in order to mitigate post-implantation complications arising from bacterial infection. In this study, a biocompatible silk film is deposited on AZ31 Mg alloy to enhance the corrosion resistance and by means of oxygen plasma etching, nature-inspired nanopatterns are fabricated on the surface of the silk film to improve the inherent antibacterial properties. The biocompatibility and antibacterial properties are determined with MC3T3-E1 osteoblast cells and E. coli and S. aureus, respectively. The antimicrobial properties of the silk coated AZ31 are better than those of the bare alloy probably due to the combined effects of the nanopatterns and alkalinity associated with leaching of Mg ions. The β-sheets formed on the silk film is found to result in 104 times reduction in the corrosion current density and 50% reduction in Mg leaching after 1day. Although degradation of the β-sheets is observed to begin after 1day, the amount of Mg ions leached to the medium from silk-coated AZ31 is still 17% lower than that from the bare one. The biomimicking nanopatterns on the natural silk film improve the corrosion resistance, biocompatibility, and antibacterial properties simultaneously and have large clinical potential.

Stiffness of the aligned fibers affects structural and functional integrity of the oriented endothelial cells

Promoting healthy endothelialization of the tissue-engineered vascular grafts is of great importance in preventing the occurrence of undesired post-implantation complications including neointimal hyperplasia, late thrombosis, and neoatherosclerosis. Previous researches have demonstrated the crucial role of scaffold topography or stiffness in modulating the behavior of the monolayer endothelial cells (ECs). However, effects of the stiffness of scaffolds with anisotropic topography on ECs within vivo like oriented morphology has received little attention. In this study, aligned fibrous substrates (AFSs) with tunable stiffness (14.68–2141.72 MPa), similar to the range of stiffness of the healthy and diseased subendothelial matrix, were used to investigate the effects of fiber stiffness on ECs’ attachment, orientation, proliferation, function, remodeling and dysfunction. The results demonstrate that stiffness of the AFSs, capable of providing topographical cues, is a crucial endothelium-protective microenvironmental factor by maintaining stable and quiescent endothelium with in vivo like orientation and strong cell–cell junctions. Stiffer AFSs exacerbated the disruption of endothelium integrity, the occurrence of endothelial-to-mesenchymal transition (EndMT), and the inflammation-induced activation in the endothelial monolayer. This study provides new insights into the understanding on how the stiffness of biomimicking anisotropic substrate regulates the structural and functional integrity of the in vivo like endothelial monolayer, and offers essential designing parameters in engineering biomimicking small-diameter vascular grafts for the regeneration of viable blood vessels. Statement of significanceIn vascular tissue engineering, promoting endothelialization on scaffold surface has been considered as a paramount strategy to reduce post-implantation complications. Electrospun aligned fibers have been known to provide contact guidance effect in directing endothelial cells' oriented growth, however, whether the formed EC monolayer in ‘correct’ orientation shape is of ‘correct’ function hasn't been explored yet. Given the recognized important role of substrate stiffness in endothelial function, AFSs across physiologically relevant range of moduli (14.68–2141.72 MPa) while maintaining consistent surface chemistry and topographical features were employed to investigate the fiber stiffness effects on ECs function in anisotropic morphology. This study will provide more insightful perspectives in the physiologically remodeling progression of vascular endothelium and design of vascular scaffolds.

Shoulder Function After Cardioverter-Defibrillator Implantation: 5-Year Follow-up

Implantable cardioverter-defibrillator (ICD) represents the main tool for prevention of sudden cardiac death. Different kinds of postimplant complications have been described; however, little is known about shoulder functional impairment and its impact on quality of life. Patients with standard indications for elective prepectoral subcutaneous ICD insertion were enrolled during a 1-year period. The impact of ICD implantation on shoulder motility, pain, general disability, and quality of life was evaluated prospectively at baseline, and after 2 weeks, 3 months, 1 year, and 5 years using the Constant score, the Numeric Pain Rating Scale, the Disabilities of the Arm, Shoulder, and Hand scale, and the Short Form-36 Health Survey questionnaire. A total of 50 patients underwent insertion of single, dual chamber, or biventricular ICDs. Two weeks after implantation, functional impairment and mild pain were observed in ipsilateral shoulder movements, with a reduction in the Short Form-36 Health Survey score. Shoulder functional impairment improved at the third-month evaluations, with almost normalization at 1-year and 5-year assessments, as well as pain and quality of life. Prepectoral subcutaneous ICD implantation may be associated with ipsilateral shoulder functional impairment that regresses partially after 3 months and completely at 1-year and 5-year assessments. The less invasive implantation technique and the relatively small size of modern ICDs, independently from types and volumes, may be relevant to the degree of postimplantation shoulder functional impairment and recovery time. Shoulder function should be assessed at routine checks, especially soon after ICD implantation because of potential functional impairment and subsequent impact on quality of life.

New sparse implantation technique of I-125 low-dose-rate brachytherapy using concomitant short-term hormonal treatment for low and intermediate-risk prostate cancer: An initial study of therapeutic feasibility

This study aimed to evaluate the oncological outcomes and post-implantation complications of the concurrent androgen deprivation therapy (ADT) with I-125 low-dose-rate (LDR)-prostate brachytherapy (sparse implantation technique: SIT) in comparison with the conventional non-ADT using whole gland brachytherapy (CWT). 302 localized prostate cancer (PCa) patients were treated with CWT (implantation dose: 145 Gy) and 215 patients were treated with SIT, which applied reduced implantation dose of 123.5 Gy. SIT group had ADT consisting of bicalutamide 50 mg/day plus 3-month depot (11.25 mg) of leuprolide acetate subcutaneously on the post-implantation day-0. Post-implantation complications and biochemical-recurrence-free-survival (BCRS) were compared between the two groups. After ADT, SIT group had 40.9% patients (40.9%) with prostate volume reduction between 20–30%. At 3-months post-implantation, SIT group presented significantly better IPSS than CWT group (p = 0.038). Both groups showed decrease in IIEF-5 score at 3-months post-implantation, but ST group showed significantly better mean IIEF-5 scores (13.5) than the CWT group (11.1) (p = 0.045). For 3-months post-implantation dosimetry, both groups showed no significant differences regarding D90 (CWT 156 Gy vs. SIT 152 Gy). CWT group had 3 patients with rectal toxicity ≥radiation therapy oncology group (RTOG) grade 2 and 1 patient with urinary toxicity ≥RTOG grade 2 whereas SIT group had no patient with urinary or rectal toxicity ≥RTOG grade 2. Kaplan-Meier analyses showed no significant differences regarding PCSS were observed between the two groups (p = 0.350). The SIT group showed compatible oncological outcomes to the CWT and relatively smaller number of post-implantation complications within low- and intermediate-risk PCa patients.

Stiffness of the Aligned Fibers Affects Structural and Functional Integrity of the Oriented Endothelial Cells

Promoting healthy endothelialization of the tissue-engineered vascular grafts is of great importance in preventing the occurrence of undesired post-implantation complications including neointimal hyperplasia, late thrombosis, and neoatherosclerosis. Previous researches have demonstrated the crucial role of scaffold topography or stiffness in modulating the behavior of the monolayer endothelial cells (ECs). However, stiffness influence of the substrate/scaffold with anisotropic topography on ECs with in vivo like oriented morphology has rarely been attempted. In this study, aligned fibrous substrates (AFSs) with tunable stiffness (14.68~2141.72 MPa) resembling that of the healthy and diseased subendothelial matrix were used to investigate the effects of aligned fiber stiffness on EC attachment, orientation, proliferation, function, remodeling and dysfunction. The results demonstrate that stiffness of the AFSs capable of providing topographical cues is a crucial endothelium-protective microenvironmental factor by maintaining the long-standing, stable and quiescent endothelium with in vivo like orientation and strong cell-cell junctions. Stiffer AFSs exacerbated disruption of endothelium integrity, occurrence of endothelial-to-mesenchymal transition (EndMT), and inflammation-induced activation in endothelial monolayer. This study provides new insights into the understanding on how the stiffness of biomimicking anisotropic substrate regulates the structural and functional integrity of the in vivo like endothelial monolayer, and offers essential designing parameters in engineering biomimicking small-diameter vascular grafts for the regeneration of viable blood vessels.

Clinical Implications of Respiratory Failure in Patients Receiving Durable Left Ventricular Assist Devices for End-Stage Heart Failure.

The impact of respiratory failure on patients undergoing left ventricular assist device (LVAD) implantation is not well understood, especially since these patients were excluded from landmark clinical trials. We sought to evaluate the associations between immediate preimplant and postimplant respiratory failure on outcomes in advanced heart failure patients undergoing LVAD implantation. We included all patients in the Interagency Registry for Mechanically Assisted Circulatory Support who were implanted with continuous-flow LVADs from 2008 to 2016. Of the 16 362 patients who underwent continuous-flow LVAD placement, 906 (5.5%) required preimplant intubation within 48 hours before implantation, and 1001 (6.1%) patients developed respiratory failure within 1 week after implantation. A higher proportion of patients requiring preimplant intubation were Interagency Registry for Mechanically Assisted Circulatory Support profile 1, required mechanical circulatory support, and presented with cardiac arrest or myocardial infarction (P<0.001, all). At 1 year, 54.3% of patients intubated preimplant were alive without transplant, 20.1% had been transplanted, and 24.2% died before transplant. Patients requiring preimplant intubation had higher rates of postimplant complications, including bleeding, stroke, and right ventricular assist device implantation (P<0.01 for all). Among Interagency Registry for Mechanically Assisted Circulatory Support profile 1 patients, preimplant intubation incurred additional risk of death at 1 year compared with Interagency Registry for Mechanically Assisted Circulatory Support profile 1 patients not intubated (hazard ratio, 1.37 [95% CI, 1.13-1.65]; P=0.001). After multivariable analysis, both preimplant intubation (hazard ratio, 1.20 [95% CI, 1.03-1.41]; P=0.021) and respiratory failure within 1 week (hazard ratio, 2.54 [95% CI, 2.26-2.85]; P<0.001) were associated with higher all-cause 1-year mortality. Respiratory failure both before and after LVAD implantation identifies an advanced heart failure population with significantly worse 1-year mortality. This data might be helpful in counseling patients and their families about expectations about life with an LVAD.

Comparison of the linking arm effect on the biological performance of a CD31 agonist directly grafted on L605 CoCr alloy by a plasma-based multistep strategy.

Stents are cardiovascular implants deployed on atherosclerotic arteries that aid in reopening, sustaining, and avoiding their collapse. Nevertheless, postimplantation complications exist, and the risk of the renewal of the plaque subsists. Therefore, enhanced properties are mandatory requirements for clinics. For that purpose, a novel approach allowing the direct-grafting of bioactive molecules on cobalt-chromium devices (L605) has been developed. This original strategy involves the direct plasma functionalization of metallic surfaces with primary amines (-NH2). These groups act as anchor points to covalently graft biomolecules of interest, herein a peptide derived from CD31 (P23) with proendothelialization and antithrombotic properties. However, the biological activity of the grafted peptide could be impacted by its conformation. For this study, glutaric anhydride (GA), a short chain spacer, and polyethylene glycol (PEG) with antifouling properties were used as linking arms (LAs). The covalent grafting of the CD31 agonist on L605 by different LAs (GA-P23 and PEG-P23) was confirmed by XPS and ToF-SIMS analyses. The biological performance of these functionalized surfaces showed that, compared to the electropolished (EP) alloy, grafting the P23 with both LA increases adhesion and proliferation of endothelial cells (ECs) since day 1: EP = 68 ± 10%, GA-P23 = 101 ± 7%, and PEG-P23 = 106 ± 5% of cell viability. Moreover, ECs formed a complete monolayer at the surface, preventing clot formation (hemoglobin-free >80%). The potential of this plasma-based strategy for cardiovascular applications was confirmed by promoting a fast re-endothelialization, by improving the hemocompatibility of the alloy when coupled with the CD31 agonist and by its transfer onto commercial L605 stents, as confirmed by ToF-SIMS.

A Proof-of-Concept Demonstration for a Novel Soft Ventricular Assist Device

Patients treated by current ventricular assist devices (VADs) suffer from various post implantation complications including gastrointestinal bleeding and arteriovenous malformation. These issues are related to intrinsically mismatch of generated flow by VADs and the physiological flow. In addition, the common primary drawback of available VADs is excessive surgical dissection during implantation, which limits these devices to less morbid patients. We investigated an alternative soft VAD (SVAD) system that generates physiological flow, and designed to be implanted using minimally invasive surgery by leveraging soft materials. A soft VAD (which is an application of intraventricular balloon pump) is developed by utilizing a polyurethane balloon, which generates pulsatile flow by displacing volume within the left ventricle during its inflation and deflation phases. Our results show that the SVAD system generates an average ejection fraction of 50.18 ± 1.52% (n = 6 ± SD) in explanted porcine hearts. Since the SVAD is implanted via the apex of the heart, only a minithoracotomy should be required for implantation. Our results suggest that the SVAD system has the performance characteristics that could potentially make it useful for patients in acute and/or chronic heart failure, thus serving as a bridge-to-transplantation or bridge-to-recovery.

Complications of post-cochlear implantation in 1027 adults and children

BACKGROUNDThe number of cochlear implant (CI) recipients is increasing so there needs to be greater awareness of possible CI complications.OBJECTIVESDescribe complications of CI.DESIGNRetrospective, descriptional.SETTINGSTertiary health care center.PATIENTS AND METHODSData was collected by retrospective chart review on complications for recipients implanted for the period from January 2006 to June 2017.MAIN OUTCOME MEASURESMajor and minor post cochlear implantation complications.SAMPLE SIZE1027 cochlear implant recipients.RESULTSPost-operative complications were reported in 105 patients (10.2%). Minor complications were most often encountered (9.5%). Swelling (wound seroma or hematoma) was the most common complication. The major complication rate was only 7/105, 0.7%. Meningitis did not occur and cholesteatoma occurred in only one patient.CONCLUSIONCI is a safe surgical procedure at our center. We believe that this is probably due to the preoperative protocol, the surgical technique used, and the postoperative care conducted for all our patients. Despite this, it is important that both physicians and patients have knowledge of the possible consequences and risks posed by CI, especially in view of the fact that these patients require lifetime follow-up.LIMITATIONSFurther studies are needed, and should include more ENT centers across all regions of Saudi Arabia.

Left Ventricular Assist Devices (LVADS): History, Clinical Application and Complications.

Congestive heart failure is a major cause of morbidity and mortality as well as a major health care cost in the developed world. Despite the introduction of highly effective heart failure medical therapies and simple devices such as cardiac resynchronization therapy that reduce mortality, improve cardiac function and quality of life, there remains a large number of patients who do not respond to these therapies or whose heart failure progresses despite optimal therapy. For these patients, cardiac transplantation is an option but is limited by donor availability as well as co-morbidities which may limit survival post-transplant. For these patients, left ventricular assist devices (LVADs) offer an alternative that can improve survival as well as exercise tolerance and quality of life. These devices have continued to improve as technology has improved with substantially improved durability of the devices and fewer post-implant complications. Pump thrombosis, stroke, gastrointestinal bleeding and arrhythmias post-implant have become less common with the newest devices, making destination therapy where ventricular assist device are implanted permanently in patients with advanced heart failure, a reality and an appropriate option for many patients. This may offer an opportunity for long term survival in many patients. As the first of the totally implantable devices are introduced and go to clinical trials, LVADs may be introduced that may truly be alternatives to cardiac transplantation in selected patients. Post-implant right ventricular failure remains a significant complication and better ways to identify patients at risk as well as to manage this complication must be developed.

Neoatherosclerosis after drug-eluting stent implantation: a novel clinical and therapeutic challenge.

The recognition that obstructive disease of the epicardial coronary arteries, causing ischaemic heart disease, can be treated with a percutaneous coronary intervention (PCI) has been a major discovery in cardiology in the last 40 years contributing, in particular, to the reduction of mortality associated to acute myocardial infarction (AMI). However, even in the era of drug-eluting stent (DES) implantation, a sizable proportion of patients who undergo PCI may develop late or very late post-implantation complications, that occur in the form of restenosis, neoatherosclerosis, and/or in-stent thrombosis. Such complications are clinically relevant since they can cause AMI and negatively impact on the outcome. The underlying pathophysiological mechanisms are complex but related to inhibition of neointimal proliferation by DES that, on the hand, reduces the rate of in-stent restenosis, but, on the other hand, causes dysfunctional vessel healing, persistent inflammation, platelet activation, and adverse immunological responses. Multiple approaches have been developed or are under evaluation to target DES-related complications including pharmacotherapy, procedure-related imaging methods, novel stent designs, and drug-delivery methods. The aim of this review is to provide an update on the latest preclinical, translational, and clinical pharmacotherapeutic developments in this setting that target novel cellular mechanisms and pathways that might contribute to neoatherosclerosis. Due to the importance of secondary prevention in the reduction of DES-associated complications, this review also provides a short overview of pharmacological agents that are established or currently being investigated in this regard.

Total artificial heart implantation as a bridge to transplantation: a viable model for the future?

ABSTRACTIntroduction: Since the first total artificial heart (TAH) surgery in a human patient performed in 1969, over 1300 devices have been implanted worldwide. Patients are benefiting from increased lengths of durable support and indications have expanded beyond biventricular failure including allograft failure, severe restrictive disease, and complex congenital anomalies.Areas covered: The role of the TAH in biventricular failure, rates of successful bridge-to-transplant (BTT), and survival compared with biventricular assist devices (BiVADs) are discussed and differences between TAH and LVAD patient populations are highlighted. The device’s niche role in physiologies not amenable to single ventricle support is further described. New developments such as the 50cc Syncardia, continuous flow mechanisms (BiVACOR and Cleveland Clinic CF-TAH), and a bioprosthetic model (CARMAT) are discussed.Literature review was conducted utilizing the PubMed database selecting published research, database analyses, and case reports under ‘total artificial heart’ relevant to the paper’s aims.Expert commentary: TAH patients have high rates of successful BTT and survival on par with BiVAD-supported patients. Ongoing developments including decreased device size, continuous flow mechanisms, and use of bioprosthetic materials will ensure that the TAH will have an increasing role in advanced heart failure with increased device longevity and decreased post-implant complications.

Postapproval Community Hospital Experience in the United States with Left Atrial Appendage Closure Device (Watchman)

To review the procedural safety and postimplantation complications of Watchman device implanted at 2 community hospitals for primary prevention of systemic embolization in patients with nonvalvular atrial fibrillation (NVAF) who were not candidates for long-term oral anticoagulation (OAC). This was a retrospective case series of 48 patients carried out in 2 community hospitals in the United States. Patients with NVAF who had a CHADS2 higher than 2 or CHADS2VASc2 (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack [TIA] or thromboembolism, vascular disease, age 65-74 years, and female gender) score of 3 or higher and were not candidates for long-term OAC. These patients were selected for implantation of Watchman device. They were followed up at 45 days, 6 months, 9 months, and 12 months after implantation of Watchman device to assess for complications involving the device and to determine if anticoagulation could be discontinued at the 45 days follow-up. They were monitored for any systemic thromboembolism while off anticoagulation. The success rate of device implantation was 98% (48 of 49). Only a single patient could not get Watchman implantation because of unfavorable left atrial appendage anatomy. Access-related and device implantation-related complications were zero (0%). At 45 days follow-up and end of follow-up duration, the rate of thrombus formation on the Watchman device was 4% (2 of 48). One patient had TIA after warfarin discontinuation. With improved procedural technique and well-trained operators, Watchman implantation is feasible in a community hospital also.