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To describe outcomes associated with bridging strategies in patients with acute decompensated heart failure-related cardiogenic shock (ADHF-CS) bridged to durable left ventricular assist device (LVAD) or heart transplant (HTx).Durable LVAD or HTx recipients from 2014 to 2019 with pre-operative ADHF-CS were identified in the Society of Thoracic Surgeons Adult Cardiac Surgery Database and stratified by bridging strategy. The primary outcome was operative or 30-day post-operative mortality. Secondary outcomes included post-operative major bleeding. Exploratory comparisons between bridging strategies and outcomes were performed using overlap weighting with and without covariate adjustment. Among 9783 patients with pre-operative CS, 8777 (89.7%) had ADHF-CS. Medical therapy (N = 5013) was the most common bridging strategy, followed by intra-aortic balloon pump (IABP; N = 2816), catheter-based temporary mechanical circulatory support (TMCS; N = 417), and veno-arterial extracorporeal membrane oxygenation (VA-ECMO; N = 465). Mortality was highest in patients bridged with VA-ECMO (22%), followed by catheter-based TMCS (10%), IABP (9%), and medical therapy (7%). Adverse post-operative outcomes were more frequent in LVAD recipients compared with HTx recipients.Among patients with ADHF-CS bridged to HTx or durable LVAD, the highest rates of death and adverse events during index hospitalization were observed in those bridged with VA-ECMO, followed by catheter-based TMCS, IABP, and medical therapy. Patients who received durable LVAD had higher rates of post-operative complications compared with HTx recipients. Prospective trials are needed to define optimal bridging strategies in patients with ADHF-CS. This article is protected by copyright. All rights reserved.

Acute heart failure (HF) is an important complication of coronavirus disease 2019 (COVID-19) and has been hypothesized to relate to inflammatory activation.We evaluated consecutive intensive care unit (ICU) admissions for COVID-19 across 6 centers in the Critical Care Cardiology Trials Network, identifying patients with vs without acute HF. Acute HF was subclassified as de novo vs acute-on-chronic, based on the absence or presence of prior HF. Clinical features, biomarker profiles and outcomes were compared.Of 901 admissions to an ICU due to COVID-19, 80 (8.9%) had acute HF, including 18 (2.0%) with classic cardiogenic shock (CS) and 37 (4.1%) with vasodilatory CS. The majority (n = 45) were de novo HF presentations. Compared to patients without acute HF, those with acute HF had higher cardiac troponin and natriuretic peptide levels and similar inflammatory biomarkers; patients with de novo HF had the highest cardiac troponin levels. Notably, among patients critically ill with COVID-19, illness severity (median Sequential Organ Failure Assessment, 8 [IQR, 5-10] vs 6 [4-9]; P = 0.025) and mortality rates (43.8% vs 32.4%; P = 0.040) were modestly higher in patients with vs those without acute HF.Among patients critically ill with COVID-19, acute HF is distinguished more by biomarkers of myocardial injury and hemodynamic stress than by biomarkers of inflammation.

Telemedicine use increased dramatically during the COVID-19 pandemic; however, questions remain as to how telemedicine use impacts care.The purpose of this study was to examine the association of increased telemedicine use on rates of timely follow-up and unplanned readmission after acute cardiovascular hospital encounters.We examined hospital encounters for acute coronary syndrome, arrhythmia disorders, heart failure (HF), and valvular heart disease from a large U.S., multisite, integrated academic health system among patients with established cardiovascular care within the system. We evaluated 14-day postdischarge follow-up and 30-day all-cause unplanned readmission rates for encounters from the pandemic "steady state" period from May 24, 2020 through December 31, 2020, when telemedicine use was high and compared them to those of encounters from the week-matched period in 2019 (May 26, 2019, through December 31, 2019), adjusting for patient and encounter characteristics.The study population included 6,026 hospital encounters. In the pandemic steady-state period, 40% of follow-ups after these encounters were conducted via telemedicine vs 0% during the week-matched period in 2019. Overall, 14-day follow-up rates increased from 41.7% to 44.9% (adjusted difference: +2.0 percentage points [pp], 95% CI: -1.1 to +5.1 pp,Increased telemedicine use during the COVID-19 pandemic was associated with earlier follow-ups, particularly after HF encounters. Readmission rates did not increase, suggesting that the shift to telemedicine did not compromise care quality.

Background Morbidity and mortality associated with COVID-19 has increased exponentially, and patients with cardiovascular (CV) disease are at risk for poor outcomes. Several lines of evidence suggest a potential role for CV therapies in COVID-19 treatment. Characteristics of clinical trials of CV therapies related to COVID-19 registered on ClinicalTrials.gov have not been described. Methods ClinicalTrials.gov was queried on August 7, 2020 for COVID-19 related trials. Studies evaluating established CV drugs, other fibrinolytics (defibrotide), and extracorporeal membrane oxygenation were included. Studies evaluating anti-microbial, convalescent plasma, non-colchicine anti-inflammatory, and other therapies were excluded. Trial characteristics were tabulated from study-specific entries. Results A total of 2,935 studies related to COVID-19 were registered as of August 7, 2020. Of these, 1,645 were interventional studies, and the final analytic cohort consisted of 114 studies evaluating 10 CV therapeutic categories. Antithrombotics (32.5%; n = 37) were most commonly evaluated, followed by pulmonary vasodilators (14.0%; n = 16), renin-angiotensin-aldosterone system-related therapies (12.3%; n = 14), and colchicine (8.8%; n = 10). Trials evaluating multiple CV therapy categories and CV therapies in combination with non-CV therapies encompassed 4.4% (n = 5) and 9.6% (n = 11) of studies, respectively. Most studies were designed for randomized allocation (87.7%; n = 100), enrollment of less than 1000 participants (86.8%; n = 99), single site implementation (55.3%; n = 63), and had a primary outcome of mortality or a composite including mortality (56.1%; n = 64). Most study populations consisted of patients hospitalized with COVID-19 (81.6%; n = 93). At the time of database query, 28.9% (n = 33) of studies were not yet recruiting and the majority were estimated to be completed after December 2020 (67.8%; n = 78). Most lead sponsors were located in North America (43.9%; n = 50) or Europe (36.0%; n = 41). Conclusions A minority (7%) of clinical trials related to COVID-19 registered on ClinicalTrials.gov plan to evaluate CV therapies. Of CV therapy studies, most were planned to be single center, enroll less than 1000 inpatients, sponsored by European or North American academic institutions, and estimated to complete after December 2020. Collectively, these findings underscore the need for a network of sites with a platform protocol for rapid evaluation of multiple therapies and generalizability to inform clinical care and health policy for COVID-19 moving forward.

Background: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used to treat cardiogenic shock. However, VA-ECMO might hamper myocardial recovery. The Impella unloads the left ventricle. This study aimed to evaluate whether left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO was associated with lower mortality. Methods: Data from 686 consecutive patients with cardiogenic shock treated with VA-ECMO with or without left ventricular unloading using an Impella at 16 tertiary care centers in 4 countries were collected. The association between left ventricular unloading and 30-day mortality was assessed by Cox regression models in a 1:1 propensity score–matched cohort. Results: Left ventricular unloading was used in 337 of the 686 patients (49%). After matching, 255 patients with left ventricular unloading were compared with 255 patients without left ventricular unloading. In the matched cohort, left ventricular unloading was associated with lower 30-day mortality (hazard ratio, 0.79 [95% CI, 0.63–0.98]; P =0.03) without differences in various subgroups. Complications occurred more frequently in patients with left ventricular unloading: severe bleeding in 98 (38.4%) versus 45 (17.9%), access site–related ischemia in 55 (21.6%) versus 31 (12.3%), abdominal compartment in 23 (9.4%) versus 9 (3.7%), and renal replacement therapy in 148 (58.5%) versus 99 (39.1%). Conclusions: In this international, multicenter cohort study, left ventricular unloading was associated with lower mortality in patients with cardiogenic shock treated with VA-ECMO, despite higher complication rates. These findings support use of left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO and call for further validation, ideally in a randomized, controlled trial.

The United Network for Organ Sharing (UNOS) implemented a revised donor heart allocation system on October 18, 2018 with principle aims to reduce waitlist mortality, enhance geographic organ sharing, and improve organ distribution equity. Five recently published analyses compared outcomes of heart transplant (HT) recipients transplanted under the revised versus previous system. All demonstrated increased pre-transplant temporary mechanical circulatory support use and graft ischemic times under the revised system. However, despite using data from the same UNOS Registry, three analyses demonstrated increased risk of post-transplant mortality under the revised system, while two others found no significant difference in mortality risk. These studies differed in their analytic cohorts, study periods, follow-up duration, and statistical methodologies. Additionally, some may have introduced survivor bias or violated non-informative censoring. Given these variable findings, longer-term outcome assessment is warranted before the HT community can truly understand the impact of the 2018 UNOS system revision on post-transplant outcomes.

The identification of factors determining whether a lesion progresses, destabilizes or becomes quiescent remains a challenge. Wall or endothelial shear stress (WSS or ESS, respectively), the frictional force acting on the lumen wall, is strongly associated with changes in the natural history of lesions. Several clinical intravascular imaging studies have shown a clear link between disturbed flow, typically characterized by low WSS, and plaque growth. In support of these studies, in-vitro experiments of shear stress have identified several mechanisms promoting atherosclerosis. More recently, the relationship between WSS and major adverse cardiac events has been explored. Improvements in coronary computed tomography angiography (CCTA) image resolution and quality has allowed for the calculation of WSS from CT. In this review, we provide an introduction to WSS, highlight important human and animal intravascular-based WSS studies, and discuss CT-based WSS studies to date. Finally, we discuss future directions of CCTA and WSS computation.

As the prevalence of advanced heart failure continues to rise, treatment strategies for select patients include heart transplantation or durable left ventricular assist device (LVAD) support, both of which improve quality of life and extend survival. Recently, the HeartMate 3 has been incorporated into clinical practice, the United Network for Organ Sharing donor heart allocation system was revised, and the management of LVAD-related complications has evolved. Contemporary LVAD recipients have greater preoperative illness severity, but survival is higher and adverse event rates are lower compared with prior eras. This is driven by advances in device design, patient selection, surgical techniques, and long-term management. However, bleeding, infection, neurologic events, and right ventricular failure continue to limit broader implementation of LVAD support. Ongoing efforts to optimize management of patients implanted with current devices and parallel development of next-generation devices are likely to further improve outcomes for patients with advanced heart failure.

AIMS Implementation of guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) remains incomplete. Non-cardiovascular hospitalization may present opportunities for GDMT optimization. We assessed the efficacy and durability of a virtual, multidisciplinary 'GDMT Team' on medical therapy prescription for HFrEF. METHODS AND RESULTS Consecutive hospitalizations in patients with HFrEF (ejection fraction ≤40%) were prospectively identified from 3 February to 1 March 2020 (usual care group) and 2 March to 28 August 2020 (intervention group). Patients with critical illness, de novo heart failure, and systolic blood pressure

Purpose: To assess the efficacy and safety of antihypertensive drug classes, including angiotensin converting enzyme inhibitors/angiotensin II receptor blockers (ACEi/ARB), beta blockers (BB), calcium channel blockers (CCB), and thiazide diuretics (TD), in subjects at high cardiovascular (CV) risk. Methods: SPRINT was a randomized, controlled, open-label trial in which individuals without diabetes aged ≥50 years, at high CV risk, and with a systolic blood pressure (SBP) 130-180 mmHg were randomized to intensive (SBP target Results: Of 9361 participants, baseline use of antihypertensive agents was as follows: ACEi/ARB in 1317 (14%), BB in 911 (10%), CCB in 796 (9%), and TD in 979 (10%). A total of 1366 (15%) subjects did not have a record of being on an antihypertensive drug at baseline. In the intensive BP control group, use of a BB-based regimen at baseline was associated with a significantly higher risk of the primary outcome when compared with no medications ( Figure ). Similar patterns were observed for secondary efficacy endpoints. The risk of serious adverse events tended to be lower in patients receiving a treatment regimen containing either an ACEi/ARB or a TD compared with those receiving a regimen containing a BB or a CCB ( Figure ). Conclusions: In SPRINT, the risk of adverse events was lowest in patients who were not on an antihypertensive drug at baseline. ACEi/ARB-based and TD-based regimens appeared to have the best balance between efficacy and safety.

Bioprosthetic valve thrombosis (BPVT) is more common than previously thought and likely underreported. BPVT can be accurately diagnosed with cardiac imaging and treated successfully with anticoagulation, thus preventing reoperation. We hereby report a case of recurrent BPVT in the mitral position successfully treated with anticoagulation along with review of literature.

Background Although patients with cardiovascular disease face excess risks of severe illness with coronavirus disease-2019 (COVID-19), there may be indirect consequences of the pandemic on...

Importance The new United Network for Organ Sharing (UNOS) donor heart allocation system gives priority to patients supported with nondischargeable mechanical circulatory support (MCS) devices while awaiting heart transplant. Whether there has been a change in temporary MCS use in cardiac intensive care units (CICUs) since the implementation of this policy is unknown. Objectives To examine whether the UNOS donor heart allocation system revision in October 2018 was associated with changes in temporary MCS use in CICUs and whether temporary MCS use differed between US transplant centers and US nontransplant centers and Canadian centers. Design, Setting, and Participants In this cohort study, 14 centers from the Critical Care Cardiology Trials Network (CCCTN), a multicenter network of tertiary CICUs in North America, contributed 2-month snapshots of consecutive medical CICU admissions between September 1, 2017, and September 1, 2018 (prerevision period), and October 1, 2018, and September 1, 2019 (postrevision period). CICUs were classified as US transplant centers (n = 7) or other CICUs (US nontransplant centers or Canadian centers; n = 7). Exposure Revision to the UNOS donor heart allocation system. Main Outcomes and Measures Treatment with temporary MCS (intra-aortic balloon pump, microaxial intracardiac ventricular assist device, percutaneous centrifugal ventricular assist device, venoarterial extracorporeal membrane oxygenation, or surgically implanted, nondischargeable MCS device) during hospital admission. Results A total of 384 admissions for acute, decompensated, heart failure–related cardiogenic shock (ADHF-CS) were included, among which 248 (64.6%) were to US transplant centers; 126 admissions (51%) were in the prerevision period and 122 (49%) were in the postrevision period. The mean (SD) patient age was 61.2 (14.6) years; 246 patients (64.1%) were male. The proportion of admissions with ADHF-CS managed with temporary MCS at US transplant centers significantly increased from 25.4% (32 of 126 admissions) before to 42.6% (52 of 122 admissions) after the UNOS allocation system changes (P = .004). In other CICUs, the proportion did not significantly change (24.5% [13 of 53 admissions] to 24.1% [20 of 83 admissions];P = .95). After multivariable adjustment, patients admitted to US transplant centers in the postrevision period were more likely to receive temporary MCS compared with those admitted in the prerevision period (adjusted odds ratio, 2.19; 95% CI, 1.13-4.24;P = .02). Conclusions and Relevance In the year after implementation of the new UNOS donor heart allocation system, temporary MCS use in patients admitted with ADHF-CS increased in US transplant centers but not in other CICUs. Whether this shift in practice will affect outcomes of patients with ADHF-CS or organ distribution should be evaluated.

The natural history of coronary atherosclerosis is complex and atherosclerotic plaques exhibit large morphologic and functional variability within the same individual as well as over time. The purpose of this article is to review the role of blood flow patterns and shear stress on the development of microvascular and epicardial endothelial dysfunction and atherosclerosis progression.Recent breakthroughs in cardiovascular imaging have facilitated in-vivo characterization of the anatomic and functional characteristics of atherosclerotic plaques and have highlighted the role of endothelial shear stress and epicardial and microvascular endothelial dysfunction in the natural history of coronary atherosclerosis.There is an important need to identify individual lesions which may progress to vulnerable plaque in order to provide early therapeutic management. Evaluation of endothelial shear stress, local blood flow patterns, epicardial and microvascular endothelial dysfunction, as well as their complex associations might indicate those patients who have microvascular endothelial dysfunction and increased risk for upstream epicardial endothelial dysfunction and plaque progression. Such high-risk patients could potentially be targeted for more intensive therapeutic strategies to prevent the progression of both microvascular and epicardial atherosclerotic manifestations.

Introduction Optimal antithrombotic therapy after transcatheter aortic valve replacement (TAVR) remains unclear. We evaluated the association between antithrombotic regimens and outcomes in TAVR patients. Methods We retrospectively analyzed consecutive patients who underwent TAVR at a single academic center from April 2009 to March 2014. Antithrombotic regimens were classified as single or dual antiplatelet therapy (AP), single antiplatelet plus anticoagulant (SAC), or triple therapy (TT). The primary endpoint was a composite of death, myocardial infarction (MI), stroke, and major bleeding. Adjusted hazard ratios (HRs) were obtained with best subset variable selection methods using bootstrap resampling. Results Of 246 patients who underwent TAVR, 241 were eligible for analysis with 133, 88, and 20 patients in the AP, SAC, and TT groups, respectively. During a median 2.1-year follow-up, 53.5% had at least one endpoint—the most common was death (68%), followed by major bleeding (23%), stroke (6%), and MI (3%). At 2 years, the composite outcome occurred in 70% of TT, 42% of SAC, and 31% of AP patients. Compared to AP, adjusted HRs for the composite outcome were 2.88 [95% Confidence intervals (CI) (1.61–5.16); p = 0.0004] and 1.66 (95% CI [1.13-2.42]; p = 0.009) in the TT and SAC groups, respectively. Mortality rates at 2 years were 61% in the TT, 32% in the SAC, and 26% in the AP groups (p = 0.005). Conclusions The risk of the composite outcome of death, MI, stroke, or major bleeding at 2-year follow-up was significantly higher in TAVR patients treated with TT or SAC versus AP, even after multivariate adjustment.

Introduction Implementation of GDMT for HFrEF remains low. We assessed the feasibility of a virtual GDMT Team for optimization of GDMT during hospitalization for non-CV conditions. Hypothesis A GDMT Team will improve GDMT optimization compared with usual care. Methods Consecutive hospitalized patients with HFrEF≤40% were prospectively identified. Patients with critical illness, cardiology consult, de-novo HF, COVID-19 & SBP ≤90mmHg were excluded. February 3 to March 1, 2020 served as a pre-intervention period during which patients were screened, but did not receive GDMT Team interventions. From March 2 to June 21, 2020, a pharmacist-physician team provided up to 1 suggestion daily for GDMT optimization (evidence-based s-blockers, ACEi/ARB/ARNI, & MRA) to treating teams based on an evidence-based algorithm. The primary outcome of a composite GDMT optimization score, the net of positive therapeutic changes (+1 for new initiations/uptitrations) & negative therapeutic changes (-1 for discontinuations/downtitrations) during hospitalization, was compared between the pre- vs. post-intervention periods. Multivariable linear regression models were built adjusting associations for clinical factors. Safety outcomes requiring intervention or GDMT downtitration were identified. Results Of 187 encounters, 84 (45%) met eligibility criteria: 28 pre-intervention, 56 post-intervention. Mean age was 68±11 yrs, 70% men, and 61% White. Of 88 GDMT Team suggestions, 49 (56%) were followed by discharge. During the intervention, cumulative COVID-19 hospitalizations rose from 0 to 11085 in MA. Mean GDMT optimization score was -0.14 (95% CI: -0.58 to +0.30) pre-intervention & +0.64 (95% CI: +0.35 to +0.93) post-intervention (P=0.004). In a model inclusive of demographics, comorbidities, vital signs, potassium levels, eGFR, & LVEF, the intervention was the only factor associated with higher GDMT optimization score (β coeff 0.89; P=0.008). Safety events included 1 instance each of AKI, hyperkalemia, bradycardia, & hypotension. Conclusion Admission for non-CV conditions is a feasible setting for GDMT optimization. A virtual GDMT Team was associated with improved GDMT; this implementation strategy warrants testing in a prospective RCT.

An increasing number of patients transition to advanced-stage heart failure refractory to medical therapy. Left ventricular assist systems (LVAS) provide a bridge to candidates awaiting heart transplantation and extended device durability allows permanent implantation referred to as destination therapy. Noninvasive imaging plays a pivotal role in the optimal management of patients implanted with durable mechanical circulatory support (MCS) devices. Several advances require an updated perspective of multi-modality imaging in contemporary LVAS management. First, there has been substantial evolution of devices such as the introduction of the fully magnetically levitated HeartMate 3 pump (Abbott, Abbott Park, Illinois). Second, imaging beyond the device, of the peripheral system, is increasingly recognized as clinically relevant. Third, U.S. Food and Drug Administration recalls have called attention to LVAS complications beyond pump thrombosis that are amenable to imaging-based diagnosis. Fourth, there is increased availability of multimodality imaging, such as computed tomography and positron emission tomography, at many centers across the world. In this review, the authors provide a practical and contemporary approach to multi-modality imaging of current-generation durable MCS devices. As the use of LVAS and other novel MCS devices increases globally, it is critical for clinicians caring for LVAS patients to understand the roles of various imaging modalities in patient evaluation and management.

There has been a recent proliferation of consumer health devices (CHDs) that enable user-initiated screening for a variety of diseases. These devices represent a paradigm shift in the deployment of disease screening, a process that has historically been led by clinicians following the guidance of professional bodies. The detection of AF via CHDs is a contemporary example of this phenomenon and highlights several important implications of the shift of disease screening from clinicians to CHD users. These include responsibility for patient data and outcomes, healthcare costs and access, and an evolution of the patient-provider relationship. However, as CHD technologies mature and become more affordable, they have the potential to detect actionable subclinical disease and improve health. Rather than allow CHDs to enter the marketplace organically with the potential for unintended negative consequences, it is critical that clinical, research, and industry communities proactively collaborate and establish best practices for their use.

The updated UNOS heart transplantation allocation system, implemented in 10/2018, gives priority to pts treated with non-dischargeable mechanical circulatory support (MCS) devices while awaiting heart transplant. Whether there has been a change in temporary MCS use in cardiac intensive care units (

Transplant (tplant) coronary artery disease (TCAD) is an immunologic phenomenon and a major cause of morbidity/mortality after heart tplant. Low ESS drives plaque behavior in native CAD, but its role in TCAD, with its prominent immunologic environment, has not been studied. We studied 21 pts (av

Objectives The aim of this study was to evaluate the association between pre-procedural left ventricular hypertrophy (LVH) patterns and clinical outcomes after transcatheter aortic valve replacement (TAVR). Background The association between pre-procedural LVH pattern and severity and clinical outcomes after TAVR is uncertain. Methods Patients (n = 31,199) across 422 sites who underwent TAVR from November 2011 through June 2016 as part of the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapies) Registry linked with the Centers for Medicare and Medicaid Services database were evaluated by varying LVH patterns, according to sex-specific cutoffs for left ventricular mass index and relative wall thickness. The association between LVH pattern (concentric remodeling, concentric LVH, and eccentric LVH) and outcomes (rates of mortality, myocardial infarction [MI], stroke, new dialysis requirement) at 1-year follow-up were evaluated using multivariate hazard models. Results There were no significant associations between concentric remodeling (death: adjusted hazard ratio [HR]: 1.03; 95% confidence interval [CI]: 0.93 to 1.15; MI: HR: 1.05; 95% CI: 0.76 to 1.46; stroke: HR: 1.11; 95% CI: 0.89 to 1.39; new dialysis: HR: 0.86; 95% CI: 0.64 to 1.15), concentric LVH (death: HR: 1.04; 95% CI: 0.95 to 1.15; MI: HR: 1.12; 95% CI: 0.82 to 1.52; stroke: HR: 1.14; 95% CI: 0.92 to 1.40; new dialysis: HR: 1.17; 95% CI: 0.90 to 1.52), or eccentric LVH (death: HR: 0.98; 95% CI: 0.87 to 1.10; MI: HR: 1.07; 95% CI: 0.71 to 1.63; stroke: HR: 1.01; 95% CI: 0.78 to 1.32; new dialysis: HR: 1.25; 95% CI: 0.92 to 1.70) and outcomes at 1 year compared with patients without LVH. Conclusions In a contemporary cohort of patients who underwent TAVR, pre-procedural LVH according to left ventricular mass index and relative wall thickness was not associated with adverse outcomes at 1-year follow-up. TAVR is likely to benefit patients with severe aortic stenosis regardless of the presence of LVH.

The optimal blood pressure (BP) target to reduce the risk of cardiovascular (CV) events remains uncertain, especially in patients with coronary artery disease (CAD). Results from the Systolic Blood Pressure Intervention Trial (SPRINT) suggest that targeting a systolic BP120mmHg decreases the rate of death and CV events in patients with hypertension and increased CV risk. We sought to evaluate the real-world applicability of SPRINT to patients with atherothrombosis.We divided 35,411 hypertensive patients from the REACH registry into SPRINT-eligible and SPRINT-ineligible based on the trial's inclusion and exclusion criteria. We also determined the mean BP and the percentage of patients who had a systolic BP120mmHg in each group.A total of 11,993 (33.9%) patients were SPRINT-eligible, and 23,418 (66.1%) were SPRINT-ineligible. The most common reason for SPRINT ineligibility was diabetes mellitus (64.7%). Average BP was similar in both groups (139/79mmHg in SPRINT-eligible patients versus 140/79mmHg in SPRINT-ineligible patients). A total of 10.7% of SPRINT-eligible patients and 10.6% of SPRINT-ineligible patients had a systolic BP120mmHg.Overall, these results indicate that in a large, global registry, most patients with atherothrombosis would not have been eligible for SPRINT and were rarely being treated to a systolic BP120mmHg. Further dedicated investigation is warranted to determine the optimal BP target in this vulnerable patient population.

Objective A randomized study comparing efficacy and safety of a new 75 mg/1 ml formulation of injectable diclofenac sodium designed for intra-deltoid use with the conventional 75 mg/3 ml formulation given by the intra-gluteal route. Design This was an open-label, multicentric, randomized clinical trial. Methods A total of 250 adult patients with post-operative pain were randomized to receive either an injection diclofenac 75 mg/1 ml or diclofenac 75 mg/3 ml. Primary efficacy criteria were time to onset of analgesia and reduction in pain intensity. Severity of pain at site of injection and side effects were also evaluated. Results 232 patients completed the study. The mean times to onset of anal-gesia were comparable (16.17 ± 12.70 min in the diclofenac 75 mg/1 ml group and 19.16 ± 11.79 min in the diclofenac 75 mg/3 ml group). However, significantly more patients achieved analgesia in less than 5 min and had less pain at the site of injection with the 1 ml formulation. The need for rescue medication was also lower with the 1 ml formulation (2.5% vs. 9.82%). No side effects were reported. A significantly larger number of patients and physicians rated the efficacy and safety of injectable diclo-fenac 75 mg/1 ml as excellent. Conclusion Both formulations were effective and safe in the management of post-operative pain with a significantly lower need for rescue analgesia and less pain at site of injection with diclofenac 75 mg/1 ml formulation. The 1 ml formulation had an added advantage of intra-deltoid use. This would be specially helpful in obese/overweight patients with a thick subcutaneous pad of fat over the gluteal region.

Importance Expensive biological mesh materials are increasingly used to reinforce abdominal wall hernia repairs. The clinical and cost benefit of these materials are unknown. Objectives To review the published evidence on the use of biological mesh materials and to examine the US Food and Drug Administration (FDA) approval history for these devices. Evidence Acquisition Search of multiple electronic databases (Ovid, MEDLINE, EMBASE, Cochrane Systematic Reviews, Cochrane Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, and Cochrane National Health Service Economic Evaluation Database) to identify articles published between 1948 and June 30, 2015, on the use of biological mesh materials used to reinforce abdominal wall hernia repair. Keywords searched included surgical mesh, abdominal hernia, recurrence, infection, fistula, bioprosthesis, biocompatible materials, absorbable implants, dermis , and collagen . The FDA online database for 510(k) clearances was reviewed for all commercially available biological mesh materials. The median national price for mesh materials was established by a benchmarking query through several Integrated Delivery Network and Group Purchasing Organization tools. Evidence Synthesis Of 274 screened articles, 20 met the search criteria. Most were case series that reported results of convenience samples of patients at single institutions with a variety of clinical problems. Only 3 of the 20 were comparative studies. There were no randomized clinical trials. In total, outcomes for 1033 patients were described. Studies varied widely in follow-up time, operative technique, meshes used, and patient selection criteria. Reported outcomes and clinical outcomes, such as fistula formation and infection, were inconsistently reported across studies. Conflicts of interest were not reported in 16 of the 20 studies. Recurrence rates ranged from 0% to 80%. All biological mesh devices were approved by the FDA based on substantial equivalence to a group of nonbiological predicate devices that, on average, were one-third less costly. Conclusions and Relevance There is insufficient evidence to determine the extra costs associated with or the clinical efficacy of biological mesh materials for the repair of abdominal wall hernia.