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Background Influenza vaccine effectiveness (VE) against a spectrum of severe disease, including critical illness and death, remains poorly characterized. Methods We conducted a test-negative study in an intensive care unit (ICU) network at 10 US hospitals to evaluate VE for preventing influenza-associated severe acute respiratory infection (SARI) during the 2019–2020 season, which was characterized by circulation of drifted A/H1N1 and B-lineage viruses. Cases were adults hospitalized in the ICU and a targeted number outside the ICU (to capture a spectrum of severity) with laboratory-confirmed, influenza-associated SARI. Test-negative controls were frequency-matched based on hospital, timing of admission, and care location (ICU vs non-ICU). Estimates were adjusted for age, comorbidities, and other confounders. Results Among 638 patients, the median (interquartile) age was 57 (44–68) years; 286 (44.8%) patients were treated in the ICU and 42 (6.6%) died during hospitalization. Forty-five percent of cases and 61% of controls were vaccinated, which resulted in an overall VE of 32% (95% CI: 2–53%), including 28% (−9% to 52%) against influenza A and 52% (13–74%) against influenza B. VE was higher in adults 18–49 years old (62%; 95% CI: 27–81%) than those aged 50–64 years (20%; −48% to 57%) and ≥65 years old (−3%; 95% CI: −97% to 46%) (P = .0789 for interaction). VE was significantly higher against influenza-associated death (80%; 95% CI: 4–96%) than nonfatal influenza illness. Conclusions During a season with drifted viruses, vaccination reduced severe influenza-associated illness among adults by 32%. VE was high among young adults.

Background Test-negative design studies for evaluating influenza vaccine effectiveness (VE) enroll patients with acute respiratory infection. Enrollment typically occurs before influenza status is determined, resulting in over-enrollment of influenza-negative patients. With availability of rapid and accurate molecular clinical testing, influenza status could be ascertained before enrollment, thus improving study efficiency. We estimate potential biases in VE when using clinical testing. Methods We simulate data assuming 60% vaccinated, 25% of those vaccinated are influenza positive, and VE of 50%. We show the effect on VE in 5 scenarios. Results Vaccine effectiveness is affected only when clinical testing preferentially targets patients based on both vaccination and influenza status. Vaccine effectiveness is overestimated by 10% if nontesting occurs in 39% of vaccinated influenza-positive patients and 24% of others. VE is also overestimated by 10% if nontesting occurs in 8% of unvaccinated influenza-positive patients and 27% of others. Vaccine effectiveness is underestimated by 10% if nontesting occurs in 32% of unvaccinated influenza-negative patients and 18% of others. Conclusions Although differential clinical testing by vaccine receipt and influenza positivity may produce errors in estimated VE, bias in testing would have to be substantial and overall proportion of patients tested would have to be small to result in a meaningful difference in VE.

Most persons infected with SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), develop virus-specific antibodies within several weeks, but antibody titers might decline over time. Understanding the timeline of antibody decline is important for interpreting SARS-CoV-2 serology results. Serum specimens were collected from a convenience sample of frontline health care personnel at 13 hospitals and tested for antibodies to SARS-CoV-2 during April 3-June 19, 2020, and again approximately 60 days later to assess this timeline. The percentage of participants who experienced seroreversion, defined as an antibody signal-to-threshold ratio >1.0 at baseline and

Background:While numerous investigations have described worse outcomes for patients undergoing emergent procedures at night, few studies have investigated the impact of nighttime on the outcomes of emergent endotracheal intubation (EEI). We hypothesized that for patients requiring EEI at night, the outcome of first pass success would be lower as compared to during the day.Methods:We performed a retrospective cohort study of all patients admitted to our institution between January 1st, 2016 and July 17st, 2019 who underwent EEI outside of an emergency department or operating room. Nighttime was defined as between 7:00 pm and 6:59 am. The primary outcome was the rate of first pass success. Logistic regression was utilized with adjustment for demographic, morbidity and procedure related covariables.Results:The final examined cohort included 1,674 EEI during the day and 1,229 EEI at night. The unadjusted rate of first pass success was not different between the day and night (77.5% vs. 74.6%, unadjusted odds ratio (OR): 0.85; 95% confidence interval (CI): 0.72, 1.0; P = 0.073 though following adjustment for prespecified covariables the odds of first pass success was lower at night (adjusted OR: 0.83, 95% CI: 0.69, 0.99; P = 0.042. Obesity was found to be an effect modifier on first pass success rate for day vs. night intubations. In obese patients, nighttime intubations had significantly lower odds of first pass success (adjusted OR: 0.71, 95% CI: 0.52, 0.98; P = 0.037).Discussion:After adjustment for patient and procedure related factors, we have found that the odds of first pass success is lower at night as compared to the day. This finding was, to some degree, driven by obesity which was found to be a significant effect modifier in this relationship.

Functional lesion assessment in stable coronary disease is considered the gold standard. The result of fractional flow reserve (FFR) in stable coronary disease is often a decision-maker for patient qualification. Taking into account the paramount position of FFR, it is crucial to acknowledge and reduce all potential bias.In the present study, we quantified the influence of elevated HR on FFR results using a preclinical model and then validated the results in a clinical setting.The relationship between FFR and HR was first explored experimentally in a porcine model. A clinical validation study was conducted in patients with isolated moderate lesions in the left anterior descending artery (LAD) or right coronary artery (RCA). In both the experimental and clinical arms, FFR was measured at resting HR and with pacing at 100, 130, 160, and 180 (for pigs) beats per minute. In the porcine model and in the clinical settings, a significant correlation between FFR and HR was confirmed in the LAD (r = 0.89, p .0001; r = 0.53, p = .00002), but not in the RCA (r = -0.19, p = .5; r = 0.14, p = .3). Post hoc analyses revealed that the FFR values in the LAD at 130/min and above tended to be significantly different from the baseline HR.The results of this study indicate that in an experimental setting, tachycardia might be responsible for an overestimation of FFR results in LAD lesions.

Supplemental Digital Content is available in the text., Background: The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of a rapidly spreading illness, Coronavirus Disease 2019 (COVID-19), affecting thousands of people around the world. Urgent guidance for clinicians caring for the sickest of these patients is needed. Methods: We formed a panel of 36 experts from 12 countries. All panel members completed the World Health Organization conflict of interest disclosure form. The panel proposed 53 questions that are relevant to the management of COVID-19 in the ICU. We searched the literature for direct and indirect evidence on the management of COVID-19 in critically ill patients in the ICU. We identified relevant and recent systematic reviews on most questions relating to supportive care. We assessed the certainty in the evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, then generated recommendations based on the balance between benefit and harm, resource and cost implications, equity, and feasibility. Recommendations were either strong or weak, or in the form of best practice recommendations. Results: The Surviving Sepsis Campaign COVID-19 panel issued 54 statements, of which four are best practice statements, nine are strong recommendations, and 35 are weak recommendations. No recommendation was provided for six questions. The topics were: 1) infection control, 2) laboratory diagnosis and specimens, 3) hemodynamic support, 4) ventilatory support, and 5) COVID-19 therapy. Conclusion: The Surviving Sepsis Campaign COVID-19 panel issued several recommendations to help support healthcare workers caring for critically ill ICU patients with COVID-19. When available, we will provide new evidence in further releases of these guidelines.

Background: There has been limited investigation into the procedural outcomes of patients undergoing emergent endotracheal intubation (EEI) by a critical care medicine (CCM) specialist outside the intensive care unit (ICU). We hypothesized that EEI outside an ICU would be associated with lower rates of first pass success (FPS) as compared to inside an ICU. Methods: We performed a retrospective cohort study of all adult patients admitted to our academic medical center between January 1, 2016, and July 31, 2018, who underwent EEI by a CCM practitioner. The primary outcome of FPS was identified in the EEI procedure note. Secondary outcomes included difficult intubation (> 2 attempts at laryngoscopy) and mortality following EEI. Results: In total, 1958 patients (1035 [52.9%] inside ICU and 923 [47.1%]) outside an ICU) were included in the final cohort. Unadjusted rate of FPS was not different between patients intubated out of the ICU and patients intubated inside of the ICU (689 [74.7%] vs 775 [74.9%]; P = .91). There was also no difference in FPS between groups after adjusting for predictors of difficult intubation and baseline covariates (odds ratio: 0.95; 95% confidence interval, 0.75-1.2, P = .65). Mortality of patients undergoing EEI out of the ICU was higher at each examined time interval following EEI. Discussion: For EEI done by CCM practitioners, rate of FPS is not different between patients undergoing EEI outside an ICU as compared to inside an ICU. Despite the lack of difference between rates of procedural success, patient mortality following EEI outside an ICU is higher than EEI inside an ICU at all examined time points during hospitalization.

Rationale: Prone positioning is a well-established recruitment maneuver to improve oxygenation and decrease mortality in intubated patients with severe acute respiratory distress syndrome (ARDS). There is evolving literature in utilizing proning among non-intubated and hypoxemic patients with novel coronavirus 2019 (COVID-19). However, there is paucity of evidence proving a sustained improvement in patient-centered outcomes. We aimed to determine the association between prone positioning in non-intubated patients with COVID-19 and incidence of invasive mechanical ventilation (IMV) or in-hospital mortality. Methods: We conducted a nested matched case-control analysis of adult COVID-19 patients admitted to three hospital sites in Bronx, NY between March 1, 2020 and April 1, 2020. Patients with do-not-intubate orders were excluded. Cases were defined by IMV or in-hospital mortality. Each case was matched with two controls based on age, gender, admission date within two weeks, and hospital length of stay greater than index time of matched case via risk-set sampling. Index time was defined as time after hospital admission when the case was intubated or died, whichever came first. The presence of non-intubated proning was identified from provider documentation. Results: We included 600 patients, 41 (6.8%) underwent non-intubated proning. Cases had lower SpO2/FiO2 (S/F) ratios prior to IMV or in-hospital mortality compared to controls (case median, 97 [interquartile range, 90-290] versus control median, 404 [interquartile range, 296-452]). While most providers (58.5%) documented immediate improvement in oxygenation status after initiating non-intubated proning, there was no difference in worst S/F ratios before and after non-intubated proning in both case and control (case median S/F ratio difference, 3 [interquartile range,-3-8] versus control median S/F ratio difference, 0 [interquartile range,-3-50]). In the univariate analysis, patients who underwent non-intubated proning were 2.57 times more likely to require IMV or experience in-hospital mortality (hazard ratio, 2.57;95% confidence interval, 1.17-5.64;P =.02). Following adjustment for patient level differences, we found no association between non-intubated proning and IMV or inhospital mortality (adjusted hazard ratio, 0.92;95% confidence interval, 0.34-2.45;P =.86). Conclusions: Although many providers documented an immediate improvement in oxygenation after non-intubated proning, sustained improvement was not identified. Non-intubated proning did not reduce the need for IMV or in-hospital mortality after adjustment for severity of illness and oxygenation status. While non-intubated proning may temporarily improve hypoxemia, it may lead to harmful delays in intubation and respiratory complications. Physicians should rigorously monitor respiratory parameters when attempting non-intubated proning.

Although obesity is associated with increased mortality, epidemiologic studies in heart failure have reported lower mortality in obese patients compared with matched nonobese patients (the 'obesity paradox'). However, the relationship between survival and extreme (morbid) obesity (BMI ≥ 40) is poorly understood. We evaluate survival in low ejection fraction patients across a range of BMI categories, including extreme obesity.In a retrospective review, 12 181 consecutive patients receiving nuclear stress testing at a tertiary care center were stratified based on BMI and ejection fraction. Eight-year mortality data were collected using the social security death index.Normal ejection fraction patients (internal control, ejection fraction ≥50%) exhibited the J-shaped association between mortality and BMI that is observed in the general population. Among patients with reduced ejection fraction (50%), survival improved as obesity increased (P 0.0001). Those with extreme obesity had the lowest mortality (n = 1134, P 0.05).In this cohort of reduced Ejection fraction patients, the obesity paradox was observed in all weight categories, with the highest survival of all observed in the extremely obese BMI category. This further supports hypotheses that an obesity-related physiologic phenomenon affects mortality in reduced ejection fraction patients.

Background: Covid-19 associated coagulopathy (CAC) is associated with prothrombotic state and thromboembolism. However, true incidence of thromboembolic events is difficult to determine in the ICU setting. The aim of our study was to investigate the cumulative incidence of thromboembolic events in Covid-19 patients needing intensive care unit (ICU) admission and assessing the utility of point of care ultrasound (POCUS) to screen for and diagnose lower extremity deep venous thrombosis (DVT). Methods: We conducted a prospective observational study between April 22nd and May 26th, 2020 where all adult patients with the diagnosis of Covid-19 pneumonia admitted to 8 ICUs of Montefiore Medical Center were included. POCUS exam was performed on all patients at day 1 of ICU admission and at day 7 and 14 after the first exam. Results: The primary outcome was to study the cumulative incidence of thromboembolic events in Covid-19 patients needing ICU admission. A total of 107 patients were included. All patients got POCUS exam on day 1 in the ICU, 62% got day 7 and 41% got day 14 exam. POCUS diagnosed 17 lower extremity DVTs on day 1, 3 new on day 7 and 1 new on day 14. Forty patients developed 52 thromboembolic events, with the rate of 37.3%. We found a high 45-day cumulative incidence of thromboembolic events of 37% and a high 45-day cumulative incidence of lower and upper extremity DVT of 21% and 10% respectively. Twelve (30%) patients had failure of therapeutic anticoagulation. Occurrence of a thromboembolic event was not associated with a higher risk of mortality (HR 1.08, p value = .81). Conclusions: Covid-19 patients in ICU have a high cumulative incidence of thromboembolic events, but not associated with higher mortality. POCUS is an excellent tool to help screen and diagnose DVT during a pandemic.

Health care personnel (HCP) caring for patients with coronavirus disease 2019 (COVID-19) might be at high risk for contracting SARS-CoV-2, the virus that causes COVID-19. Understanding the prevalence of and factors associated with SARS-CoV-2 infection among frontline HCP who care for COVID-19 patients are important for protecting both HCP and their patients. During April 3-June 19, 2020, serum specimens were collected from a convenience sample of frontline HCP who worked with COVID-19 patients at 13 geographically diverse academic medical centers in the United States, and specimens were tested for antibodies to SARS-CoV-2. Participants were asked about potential symptoms of COVID-19 experienced since February 1, 2020, previous testing for acute SARS-CoV-2 infection, and their use of personal protective equipment (PPE) in the past week. Among 3,248 participants, 194 (6.0%) had positive test results for SARS-CoV-2 antibodies. Seroprevalence by hospital ranged from 0.8% to 31.2% (median = 3.6%). Among the 194 seropositive participants, 56 (29%) reported no symptoms since February 1, 2020, 86 (44%) did not believe that they previously had COVID-19, and 133 (69%) did not report a previous COVID-19 diagnosis. Seroprevalence was lower among personnel who reported always wearing a face covering (defined in this study as a surgical mask, N95 respirator, or powered air purifying respirator [PAPR]) while caring for patients (5.6%), compared with that among those who did not (9.0%) (p = 0.012). Consistent with persons in the general population with SARS-CoV-2 infection, many frontline HCP with SARS-CoV-2 infection might be asymptomatic or minimally symptomatic during infection, and infection might be unrecognized. Enhanced screening, including frequent testing of frontline HCP, and universal use of face coverings in hospitals are two strategies that could reduce SARS-CoV-2 transmission.

Prolonged symptom duration and disability are common in adults hospitalized with severe coronavirus disease 2019 (COVID-19). Characterizing return to baseline health among outpatients with milder COVID-19 illness is important for understanding the full spectrum of COVID-19-associated illness and tailoring public health messaging, interventions, and policy. During April 15-June 25, 2020, telephone interviews were conducted with a random sample of adults aged ≥18 years who had a first positive reverse transcription-polymerase chain reaction (RT-PCR) test for SARS-CoV-2, the virus that causes COVID-19, at an outpatient visit at one of 14 U.S. academic health care systems in 13 states. Interviews were conducted 14-21 days after the test date. Respondents were asked about demographic characteristics, baseline chronic medical conditions, symptoms present at the time of testing, whether those symptoms had resolved by the interview date, and whether they had returned to their usual state of health at the time of interview. Among 292 respondents, 94% (274) reported experiencing one or more symptoms at the time of testing; 35% of these symptomatic respondents reported not having returned to their usual state of health by the date of the interview (median = 16 days from testing date), including 26% among those aged 18-34 years, 32% among those aged 35-49 years, and 47% among those aged ≥50 years. Among respondents reporting cough, fatigue, or shortness of breath at the time of testing, 43%, 35%, and 29%, respectively, continued to experience these symptoms at the time of the interview. These findings indicate that COVID-19 can result in prolonged illness even among persons with milder outpatient illness, including young adults. Effective public health messaging targeting these groups is warranted. Preventative measures, including social distancing, frequent handwashing, and the consistent and correct use of face coverings in public, should be strongly encouraged to slow the spread of SARS-CoV-2.

Background AKI has been reported in patients with COVID-19 pneumonia and it is associated with higher mortality. The aim of our study is to describe characteristics, outcomes, and 60-day hospital mortality of patients with COVID-19 pneumonia and AKI in the intensive care unit (ICU). Methods We conducted a retrospective study in which all adult patients with confirmed COVID-19 who were admitted to ICUs of Montefiore Medical Center and developing AKI were included. The study period ranged from March 10 to April 11, 2020. The 60-day follow-up data through June 11, 2020 were obtained. Results Of 300 adults admitted to the ICUs with COVID-19 pneumonia, 224 patients (75%) presented with AKI or developed AKI subsequent to admission. A total of 218 (97%) patients required invasive mechanical ventilation for moderate to severe acute respiratory distress syndrome (ARDS). A total of 113 (50%) patients had AKI on day 1 of ICU admission. The peak AKI stages observed were stage 1 in 49 (22%), stage 2 in 35 (16%), and stage 3 in 140 (63%) patients, respectively. Among patients with AKI, 114 patients (51%) required RRT. The mortality rate of patients requiring RRT was 70%. Of the 34 patients who were survivors, 25 (74%) were able to be weaned off RRT completely before hospital discharge. Nonsurvivors were older and had significantly higher admission and peak creatinine levels, admission hemoglobin, and peak phosphate levels compared with survivors. The 60-day hospital mortality was 67%. Conclusions COVID-19 requiring ICU admission is associated with high incidence of severe AKI, necessitating RRT in approximately half of such patients. The majority of patients with COVID-19 and AKI in ICU developed moderate to severe ARDS, requiring invasive mechanical ventilation. Timing or severity of AKI did not affect outcomes. The 60-day hospital mortality is high (67%). Patients with AKI requiring RRT have high mortality, but survivors have good rates of RRT recovery. Podcast This article contains a podcast at https://www.asn-online.org/media/podcast/K360/2020_12_31_KID0004282020.mp3

Supplemental Digital Content is available in the text., Objectives: To determine the association between prone positioning in nonintubated patients with coronavirus disease 2019 and frequency of invasive mechanical ventilation or inhospital mortality. Design: A nested case-matched control analysis. Setting: Three hospital sites in Bronx, NY. Patients: Adult coronavirus disease 2019 patients admitted between March 1, 2020, and April 1, 2020. We excluded patients with do-not-intubate orders. Cases were defined by invasive mechanical ventilation or inhospital mortality. Each case was matched with two controls based on age, gender, admission date, and hospital length of stay greater than index time of matched case via risk-set sampling. The presence of nonintubated proning was identified from provider documentation. Intervention: Nonintubated proning documented prior to invasive mechanical ventilation or inhospital mortality for cases or prior to corresponding index time for matched controls. Measurements and Main Results: We included 600 patients, 41 (6.8%) underwent nonintubated proning. Cases had lower Spo2/Fio2 ratios prior to invasive mechanical ventilation or inhospital mortality compared with controls (case median, 97 [interquartile range, 90–290] vs control median, 404 [interquartile range, 296–452]). Although most providers (58.5%) documented immediate improvement in oxygenation status after initiating nonintubated proning, there was no difference in worst Spo2/Fio2 ratios before and after nonintubated proning in both case and control (case median Spo2/Fio2 ratio difference, 3 [interquartile range, –3 to 8] vs control median Spo2/Fio2 ratio difference, 0 [interquartile range, –3 to 50]). In the univariate analysis, patients who underwent nonintubated proning were 2.57 times more likely to require invasive mechanical ventilation or experience inhospital mortality (hazard ratio, 2.57; 95% CI, 1.17–5.64; p = 0.02). Following adjustment for patient level differences, we found no association between nonintubated proning and invasive mechanical ventilation or inhospital mortality (adjusted hazard ratio, 0.92; 95% CI, 0.34–2.45; p = 0.86). Conclusions: There was no significant association with reduced risk of invasive mechanical ventilation or inhospital mortality after adjusting for baseline severity of illness and oxygenation status.

Background Self-expanding stents (SES) are reemerging as therapeutic alternatives to treat coronary artery disease. It has been proposed that SES can improve clinical outcomes by inducing less injury at implantation and achieving better vessel wall apposition. To date, little data exists comparing the vascular response to both methods of deployment in a controlled experimental setting. Objective To quantify differences in vascular injury and healing between second-generation SES and balloon-expandable stents (BES) and the effects of balloon postdilatation in a porcine coronary model. Methods Seventy-five bare SES (AXXESS or vProtect) and 42 BES (Vision) were implanted in porcine coronaries. A subset of these received balloon postdilatation (SES + D = 22, BES + D = 20). Follow-up was scheduled at 30 (BES = 10, BES + D = 6, SES = 19, SES + D = 8), 90 (BES = 6, BES + D = 8, SES = 19, SES + D = 8), and 180 days (BES = 6, BES + D = 6, SES = 15, SES + D = 6). Results In vivo imaging and histological analysis showed that neointimal formation peaks early (30 days) in BES. Conversely, for SES, the peak occurred later (90 days). However, the neointimal formation achieved in either group equalized at 180 days. For SES, postdilatation shortened the peak of neointimal formation to 30 days. Conversely, for BES, postdilatation delayed the peak of neointimal formation to 90 days. At 30 days, histology showed that SES had significantly less injury. However, at 90 days, injury scores tended to be higher for SES. By 180 days, injury scores were comparable between both groups. Conclusions The mechanism of stent expansion influences the degree of vascular injury and healing. The synergistic use of balloon postdilatation changes the dynamics of healing and may impact the potential beneficial effects inherent to SES technologies. © 2012 Wiley Periodicals, Inc.

OBJECTIVES: Surgical ventricular reconstruction has been used to treat ischaemic cardiomyopathy with large akinetic or dyskinetic areas. However, application of this approach requires a sternotomy, cardiopulmonary bypass and a left ventriculotomy. This study assessed the feasibility and efficacy of minimally invasive, off-pump, epicardial catheter-based ventricular reconstruction (ECVR) in an anteroapical aneurysm ovine model. METHODS: Left ventricular (LV) anteroapical myocardial infarction was induced percutaneously by coil embolization of the left anterior descending coronary artery. Eight weeks after infarction, via mini left thoracotomy and without cardiopulmonary bypass, ECVR was performed in six sheep. The scar was excluded by placing anchor pairs on the LV epicardial anterior wall and the right ventricular side of the interventricular septum under fluoroscopic guidance. LV performance was evaluated before, immediately after device implantation and after 6 weeks by echocardiography. Terminal histopathology was performed. RESULTS: ECVR was completed expeditiously in all animals without complications. Parameters obtained 6 weeks after device implantation were compared with baseline (pre-device). End-systolic volume was decreased by 38% (25.6 ± 6.1 ml vs baseline 41.2 ± 7.2 ml, P= 0.02) with preservation of stroke volume. Ejection fraction was significantly increased by 13% (48.5 ± 7% vs baseline 35.8 ± 7%, P= 0.02). The circumferential strain in the anterior septum (−7.67 ± 5.12% vs baseline −0.96 ± 2.22%, P= 0.03) and anterior wall (−9.01 ± 3.51% vs baseline −4.15 ± 1.36%, P= 0.01) were significantly improved. The longitudinal strain in apex was reversed (−3.08 ± 1.53% vs baseline 3.09 ± 3.39%, P= 0.01). Histopathology showed full endocardial healing over the anchors with appreciable reduction of the chronic infarct in the LV. CONCLUSIONS: ECVR without cardiopulmonary bypass is a less invasive alternative to current standard therapies, reverses LV remodelling and improves cardiac performance in an ovine model of anteroapical aneurysm.

AIMS To demonstrate the feasibility and safety of percutaneous delivery of the novel inflow cannula of the CircuLite® SYNERGY® pocket Micro-pump via transseptal access in the swine model. METHODS AND RESULTS After transseptal puncture, the inflow cannula system was advanced into the left atrium (LA) via the right external jugular vein and anchored onto the atrial septum under fluoroscopic and intracardiac echo guidance in 14 acute animals. Subsequently, chronic studies were performed to examine the long-term healing response to the cannula implantation with an artery-LA shunt (n=10) and overall safety of the Micro-pump components (n=6). Acute studies proved the concept of transcatheter delivery of the inflow cannula via superior venous access. The cannula tips were securely anchored in all chronic animals and appropriately endothelialised as early as two weeks. No thrombi or septal damage was observed. For the chronic pump group, device speed of 22,000 rpm (~2.0 L/min) was maintained without any adverse cardiac events. Plasma free haemoglobin assays confirmed the absence of clinically significant haemolysis. CONCLUSIONS The transcatheter delivery of the inflow cannula via superior venous access to the LA is feasible and safe. This percutaneous delivery presents a significantly less invasive alternative to deliver partial circulatory support devices.

ObjectivesThe authors aimed to validate a novel iliofemoral in-stent restenosis (ISR) model for the efficacy evaluation of paclitaxel-coated balloons (PCB) using the familial hypercholesterolemic swine (FHS).BackgroundMost of the validation work regarding PCB technologies has been performed in the coronary territory of juvenile domestic swine. Although invaluable for safety evaluation, this model is not suited for the evaluation of the efficacy of peripheral PCB technologies.MethodsTwenty-four iliofemoral segments in 12 FHS underwent balloon injury and self-expanding stent placement. After 21 days, the resulting ISR lesions were treated with either 1 μg/mm2 dose (n = 8), or 3 μg/mm2 dose (n = 8) PCB (Cotavance, Bayer Pharma AG/MEDRAD, Indianola, Pennsylvania), or with an identical uncoated control balloon (n = 8).ResultsAt termination (28 days after treatment), the percent diameter stenosis by quantitative vascular analysis in the control group was higher (31.2 ± 13.7%) compared with the 1 μg/mm2 (19.3 ± 14.0%, 38% reduction) and 3 μg/mm2 (8.6 ± 10.7%, 72% reduction) PCB groups. Intravascular ultrasound analysis showed 36% (1 μg/mm2 dose, p = 0.04) and 55% (3 μg/mm2 dose, p < 0.01) reductions in neointimal volume stenosis. In the histological analysis, the control group showed the highest degree of percent area stenosis (65 ± 14.3%). The reductions in percent area stenosis was 13.2% (p = 0.5) and 26% (p = 0.04) in the 1 μg/mm2 and 3 μg/mm2 dose groups, respectively.ConclusionsThe FHS model of iliofemoral ISR demonstrated a dose-dependent effect on the inhibition of neointimal proliferation of a clinically validated PCB technology. This model represents a positive step toward the efficacy evaluation of PCB in the peripheral vascular territory.

Background Clinical trials have consistently demonstrated benefits of Paclitaxel-coated balloons (PCB) in particular clinical situations such as in-stent restenosis and peripheral vascular interventions. However, the long-term vascular effects of bare metal stents (BMS) delivered via PCB (PCB+BMS) are still unknown. The aim of this study was to assess the long-term effects of PCB+BMS on vascular healing and neointimal formation (NF). Methods A total of 208 stents: 56 BMS crimped on PCB, 50 BMS crimped on uncoated balloons (UCB+BMS), 52 Taxus and 50 Cypher stents were implanted in normal coronary arteries of 104 pigs using 1.2:1.0 stent-to-artery ratio. Follow-up occurred at 3, 7, 28, 90, and 180 days. Vascular effects were assessed based on angiographic and histological analysis. Endothelialization was evaluated using an anti von-Willebrand Factor stain. Results At 28 days, delivery of a BMS using a PCB led to a significant reduction in NF compared to the UCB+BMS and the Taxus stent (P < 0.01). Between 28 and 180 days, the progression of NF tended to be lower in the PCB+BMS compared to all DES groups. At 90 days, the PCB+BMS (2.56 ± 0.43) and the Taxus stents (2.60 ± 0.59) had a trend toward higher inflammatory scores compared to the UCB+BMS group (1.85 ± 1.13, P = 0.09). By 180 days, inflammation and NF had completely normalized between the groups. Expression of peristrut vWF was comparable among all tested groups at 28 days. Conclusion The long-term pattern of vascular healing occurring following PCB+BMS deployment appears to be comparable to what has been reported with DES technologies. © 2012 Wiley Periodicals, Inc.

Background— Drug-coated balloons are rapidly emerging as a therapeutic alternative for the interventional treatment of peripheral vascular disease. The purpose of this study was to test the hypothesis that an angioplasty balloon coated with the mTOR inhibitor zotarolimus (ZCB) would inhibit neointimal hyperplasia in a novel injury-based superficial femoral artery model in the familial hypercholesterolemic swine. Methods and Results— A total of 44 familial hypercholesterolemic swine were included (12 designated to study tissue pharmacokinetics and 32 to study safety and efficacy). Fogarty balloon denudation was performed in all superficial femoral artery segments, followed by balloon angioplasty. In the pharmacokinetic study, a total of 24 ZCBs (300 μg/cm 2 ) were used. Zotarolimus was detected in arterial tissue at 5 minutes (162 ng/mg of tissue), 24 hours (5.9 ng/mg of tissue), and 28 days (0.007 ng/mg of tissue) after ZCB inflation. In the safety and efficacy study, superficial femoral artery segments were randomized to either high-dose (600 μg/cm 2 , n=16), low-dose (300 μg/cm 2 , n=16), or paired uncoated balloons (high-dose ZCB control, n=16; low-dose ZCB control, n=16). At 28 days, the percentage of angiographic stenosis was similar among all tested groups. Histological analysis demonstrated a reduction in neointimal formation in both ZCB groups compared with controls (high-dose ZCB 44% reduction, P =0.007; low-dose ZCB 22% reduction, P =0.08). There was no evidence of delayed arterial healing or vascular toxicity in any of the ZCB groups. Conclusions— The single delivery of zotarolimus via coated balloon is feasible, and therapeutic levels are maintained up to 28 days. The ZCB technology appears to be effective in the reduction of neointimal proliferation in the superficial femoral artery of the familial hypercholesterolemic swine.

Aims: Despite recent abundance of data on drug-coated balloon technology, the biological effects of paclitaxel coated balloon (PCB) treatment followed by bare metal stent (BMS) implantation in peripheral arteries (simulating bail-out stenting, a common clinical scenario), have not been published. Methods and results: PCB technology containing a paclitaxel-iopromide coating and identical iopromide-coated controls (without paclitaxel) were used in 16 porcine ilio-femoral arteries. The biological effects of inflating one (PCBxl) or two sequential (PCBx2) paclitaxel coated balloons before BMS implantation were compared to the single application of a control balloon (CCBx1; contrast coated balloons). At 30 days PCBx2 displayed significantly reduced late lumen loss by angiography (58% reduction vs. CCBx1; p=0.04) and neointimal area by histomorphometry (35% reduction vs. CCBx1 and 30% vs. PCBx1; p-0.02). Similarly, percent area stenosis in the PCBx2 group was reduced by 45% as compared to CCBx1 and PCBx1 (p=0.04). At this time, all parameters of vessel wall healing (including injury score, inflammation, and endothelialisation) following drug coated balloon treatment were comparable to the control group. Conclusions: Paclitaxel delivery to porcine ilio-femorals using PCB followed by BMS implantation effectively decreased neointimal proliferation. More extensive and prolonged proliferative response of the vessel after stenting (necessitating higher drug dose) could potentially explain the undetectable effect of PEBx1 relative to CCBx1 in this pilot study. Histological analysis confirmed the safety and biocompatibility of PCB technology.

In large clinical trials enrolling patients with acute coronary syndromes, a high loading dose of clopidogrel (600 mg) has been found to be more effective compared to a low loading dose (300 mg). However, the applicability of these data to stable patients who undergo elective percutaneous coronary intervention is still unclear. A total of 400 patients who underwent elective PCI were prospectively randomized to receive either 600 mg (n = 200) or 300 mg (n = 200) of clopidogrel, followed by a daily maintenance dose of 75 mg. The primary end point was the presence of major adverse cardiovascular events (combined death, myocardial infarction, acute neurologic event, stent thrombosis, and need for percutaneous or surgical revascularization of the target vessel) during hospitalization and at 30 days. The secondary end point was periprocedural vascular complications, major bleeding, and cardiac enzyme elevation. There were no differences in the primary end point among the groups immediately after the procedure (3.5% of patients in the 300-mg group vs 4.5% of those in the 600-mg group, p = 0.799) or at 30 days (6% vs 5%, respectively, p = 0.826). The rates of periprocedural vascular complications (2.5% vs 3%, respectively, p = 1.00), bleeding complications (9% vs 8.5%, respectively, p = 1.00), and cardiac enzyme elevation (11% vs 15.5%, respectively, p = 0.317) were similar between the 2 groups. In conclusion, adverse cardiovascular events and bleeding complications during the initial hospitalization and at 30-day follow-up were similar when a 600-mg loading dose of clopidogrel was used compared to the conventional dose of 300 mg.

Introduction To date, most of all new developments in stent technologies are tested in normal animals. Although invaluable in the evaluation of device safety, the juvenile domestic swine (DS) do not follow the biological healing response occurring in humans following coronary stent implantation. By using a novel swine breed afflicted with familial hypercholesterolemia (FHS), we aimed to analyse the vascular response occurring following bare metal stent (BMS) implantation by comparing in vivo endovascular imaging and histological data. Methods A total of 26 swine were included in this study (12 FHS and 14 DS). Sixty eight BMS (FHS = 28 versus DS = 40) were implanted using a 10% overstretch ratio. Imaging evaluation (IVUS and OCT) was conducted in all animals at 30 (n = 14) or 90 (n = 12) days following stent implantation. After imaging, the stented coronary segments were harvested for histological evaluation. Results At 30 days, the degree of neointimal formation analysed by OCT (%AS = DS 21.9 ± 10% versus FHS 25.4 ± 12%; p = 0.18) and histology (DS 24.6 ± 10% versus FHS 23.58 ± 10%; p = 0.8) was similar between both animal groups. At 90 days, the degree of neointimal formation in the DS group decreased in all analysed variables (−40% in IVUS neointimal volume, −57% in OCT %AS, and −30% in %AS by histology) compared to the progression of neointimal formation observed in the FHS group (+29% in IVUS neointimal volume, +27% in OCT %AS and +43% in %AS by histology). Conclusion The pattern of neointimal formation following BMS implantation in the FHS follows a progressive course that does not occur in the DS. Therefore, by providing a progressive neointimal biological response to BMS implantation, the FHS could serve as an ideal efficacy model for the validation of drug eluting stent technologies.

Background— We aimed to demonstrate that, by separating endothelial progenitor cell capture from sirolimus delivery through the application of drug to the abluminal surface of the stent, the degree of endothelialization can be enhanced. Methods and Results— Stainless steel R Stents, with biodegradable SynBiosys polymer coating with sirolimus abluminally applied and surface modified with anti-CD34 antibody were prepared at 2 dosages (low-dose sirolimus [LD-Combo, 2.5 μg sirolimus/mm] and full-dose sirolimus [Combo, 5 μg sirolimus/mm). These Combo stents and the Cypher stent (10 μg sirolimus/mm) were deployed in 98 normal porcine arteries and harvested for pharmacokinetic analysis at 0.25, 1, 3, 7, 14, 28, and 35 days. The LD-Combo stents showed faster early release (50%total dose in 72 hours) than the Combo and Cypher. At 30 days, drug release was near complete with both Combo stents, whereas 20% of drug remained on the Cypher stents. To assess efficacy, a total of 50 stents (Xience V=8, Cypher=8, Genous bioengineered R stent=6, LD-Combo=14, and Combo=14) were implanted in 18 pigs for 14 and 28 days. Optical coherence tomography was performed, and stents were harvested for histology. At 28 days, there was less neointimal thickness with Combo (0.173±0.088 mm) compared with Cypher (0.358±0.225 mm), LD-Combo (0.316±0.228 mm), and Xience V (0.305±0.252 mm; P Conclusions— Both optical coherence tomography and histology demonstrate that anti-CD34 sirolimus-eluting stents promote endothelialization while reducing neointimal formation and inflammation.

Objectives This study aimed to evaluate the accuracy of optical coherence tomography (OCT) in analyzing the neointimal response to several drug-eluting stent (DES) types by comparing OCT images acquired in vivo with corresponding histological specimens using a nondiseased porcine injury model. Background Optical coherence tomography is emerging as a promising endovascular imaging tool for the evaluation of neointimal response after DES implantation. Methods A total of 84 stents were implanted—22 ML Vision (Abbott Vascular, Santa Clara, California), 22 Xience V (Abbott Vascular), 20 Endeavor (Medtronic, Minneapolis, Minnesota), and 20 Taxus Liberte (Boston Scientific, Natick, Massachusetts) stents—in normal porcine coronary arteries and were harvested at 28 (n = 42) and 90 (n = 42) days, with the different stent types equally distributed between the 2 follow-up periods. At termination, morphometric evaluation using OCT imaging was performed in all stented arteries. Histological morphometric analysis was performed and correlated with OCT. Results A total of 622 OCT–histology matched frames acquired from all stent designs were analyzed. The luminal (13.7%) and stent (6.1%) areas were consistently larger by OCT compared with histology. The mean neointimal thickness was very similar between techniques (∼3.27% variation). There was a high correlation between OCT and histology for the evaluation of neointimal area (R2 = 0.804), luminal area (R2 = 0.825), and neointimal thickness (R2 = 0.789). Correlation for total stent area was poor (R2 = 0.352). Although the proportion of individual struts determined to be uncovered by OCT and histology was similar, there was significant variation in the estimation of strut coverage between OCT and histology when the neointimal thickness was between 20 and 80 μm. This variation converged for neointimal thicknesses between 80 and 100 μm. Conclusions Subtle differences in neointimal formation induced by current DES can be reproducibly analyzed in vivo by OCT. However, OCT measurement of stent area seems to have less correlation with histology.

Background Right heart failure (RHF) is not an infrequent complication of left ventricular assist device (LVAD) implantation. Few studies have examined outcomes for LVAD patients who subsequently develop RHF. This study details one center's experience with RHF in chronic congestive heart failure (CHF) patients. Methods One hundred eight patients with chronic CHF (≥6 months) who underwent HeartMate LVAD implantation were identified during June 1996 to July 2004. Acute heart failure patients requiring LVADs were excluded to eliminate the impact of confounding non-cardiac factors. RHF was defined as the need for a subsequent right ventricular assist device (RVAD), ≥14 days of intravenous inotropes/pulmonary vasodilators, or both. Forty-two (38.9%) RHF patients were identified. Fourteen of these required RVAD insertion. Outcome parameters included early (≤30-day) mortality, intensive care unit (ICU) length of stay (LOS), incidence of re-operation for bleeding and acute renal failure, and stroke, bridge-to-transplantation rate and post-transplantation survival rate. Results More female patients developed RHF than not (73.3% vs 26.7%, p = 0.003). RHF patients had a higher early mortality rate, greater ICU LOS, higher rates of re-operation for bleeding and renal failure, and lower bridge-to-transplantation rate than non-RHF patients (19.0% vs 6.2%, p = 0.039; 23.8 ± 23.7 vs 9.6 ± 7.1 days, p p = 0.026; 61.0% vs 22.6%, p p = 0.003; respectively). Fourteen (33.3%) RHF patients required RVAD insertion. Elevated intra-operative central venous pressure (CVP) was found to be an independent predictor of post-LVAD RHF. Overall bridge-to-transplantation rate for the entire study cohort was 73.1%. Conclusions The development of RHF after LVAD insertion confers significant morbidity and mortality. Judicious application of inotropes and pulmonary vasodilators and timely RVAD insertion, if necessary, should be maintained. Further investigations evaluating pre- and intra-operative risk factors for the development of RHF are warranted.

Introduction Although saphenous vein grafts are widely used conduits for coronary artery bypass graft surgery, their clinical value remains limited due to high failure rates. The aim of the study was to evaluate feasibility, safety, and biocompatibility of peritoneal derived vascular grafts (PDVG) formed on a silicone-coated, latex, Foley catheter in a stromal cell-derived factor (SDF-1)- enriched environment. Methods Foley catheters were implanted into the parietal wall of 8 sheep. After 21 days the peritoneal cavity was re-opened and the newly formed tissue fragments were harvested. The animals were randomly assigned into: ( 1 ) study group in which conduits were incubated in a solution containing SDF-1, ( 2 ) control group without SDF-1 incubation. Left carotid arteries were accessed and “end-to-side” anastomoses were performed. Biological materials for histological examination were taken at 4, 7, 10, and 14 days. Results and Conclusions The study proved safety, feasibility, and biocompatibility of PDVG formed on the basis of a silicone-coated, latex catheter in an SDF-1 chemokine-enriched environment. These biological grafts effectively integrated with the native high-pressure arterial environment in an ovine model and provided favorable vascular profile. The potential clinical value of this technology needs to be further elucidated in long-term preclinical and clinical studies.

Background: Self-expanding stents (SES) are reemerging as therapeutic alternatives to treat coronary artery disease. It has been proposed that SES can improve clinical outcomes by inducing less injury at implantation and achieving better vessel wall apposition.To date, little data exists comparing the vascular response to both methods of deployment in a controlled experimental setting. Objective: To quantify differences in vascular injury and healing between second-generation SES and balloon-expandable stents (BES) and the effects of balloon post-dilatation in a porcine coronary model. Methods: Seventy-five bare SES (AXXESS or vProtect) and 42 BES (Vision) were implanted in porcine coronaries. A subset of these received balloon post-dilatation(SES 1 D 5 22, BES 1 D 5 20). Follow-up was scheduled at 30 (BES 5 10, BES 1 D 56, SES 5 19, SES 1 D 5 8), 90 (BES 5 6, BES 1 D 5 8, SES 5 19, SES 1 D 5 8), and 180 days (BES 5 6, BES 1 D 5 6, SES 5 15, SES 1 D 5 6). Results: In vivo imaging and histological analysis showed that neointimal formation peaks early (30 days) in BES. Conversely, for SES, the peak occurred later (90 days). However, the neointimal formation achieved in either group equalized at 180 days. For SES, post-dilatation shortened the peak of neointimal formation to 30 days. Conversely, for BES, post-dilatation delayed the peak of neointimal formation to 90 days. At 30 days, histology showed that SES had significantly less injury. However, at 90 days, injury scores tended to be higher for SES. By 180 days, injury scores were comparable between both groups. Conclusions: The mechanism of stent expansion influences the degree of vascular injury and healing. The synergistic use of balloon post dilatation changes the dynamics of healing and may impact the potential beneficial effects inherent to SES technologies.

BACKGROUND: Periprocedural antithrombotic prophylaxis in patients undergoing surgical valve procedures (SVP) is insufficiently investigated. Low molecular weight heparin (LMWH) has been considered as an alternative to unfractionated heparin (UFH). However, safety and efficacy of this prophylaxis strategy is unknown. This study aimed to investigate safety and efficacy of periprocedural LMWH prophylaxis and determine optimal dosage and timing for periprocedural cessation and initiation. METHODS: The present study is a retrospective, single-center observational analysis of 388 patients who underwent SVP (valve replacement or valvuloplasty) between 2015 and 2016. In-hospital endpoints were bleeding, transfusions, reoperation due to bleeding, and thromboembolic events. RESULTS: Giving the first dose of LMWH on the day of SVP was a risk factor for bleeding (OR 1.07; 95% CI 1.04–1.10; p < 0.001), transfusions (OR 1.04; 95% CI 1.01–1.07; p = 0.008) and reoperation due to bleeding (OR 1.20; 95% CI 1.12–1.28; p < 0.001), with > 40 mg/day as a predictor. A higher dosage of LMWH premedication was an independent risk factor for bleeding (OR 1.02; 95% CI 1.00–1.04; p = 0.03) and transfusion (OR 1.03; 95% CI 1.01–1.05; p = 0.01), with > 60 mg/day as a predictor for these events. LMWH dosed within 24 h prior to SVP increased the risk of transfusion (AUC 0.636; 95% CI 0.496–0.762; p = 0.04). CONCLUSIONS: Bleeding is an important early concern after surgical valve procedures. Safety and efficacy of periprocedural prophylaxis with LMWH depends on dosage and the timing of its administration. The most optimal periprocedural prophylaxis in the SVP population appears to be LMWH in dosage of 40–60 mg/day, which is recommended for deep vein thrombosis prophylaxis, ceased at least one day before SVP.

The administration of bone marrow-derived stem cells may provide a new treatment option for patients with heart failure. Transcatheter cell injection may require multi-imaging modalities to optimize delivery. This study sought to evaluate whether endomyocardial injection of mesenchymal precursor cells (MPCs) could be guided by real-time 3D echocardiography (RT3DE) in treating chronic, postinfarction (MI) left ventricular (LV) dysfunction in sheep. Four weeks after induction of an anterior wall myocardial infarction in 39 sheep, allogeneic MPCs in doses of either 25 × 106 ( n = 10), 75 × 106 ( n = 9), or 225 × 106 ( n = 10) cells or nonconditioned control media ( n = 10) were administered intramyocardially into infarct and border zone areas using a catheter designed for combined fluoroscopic and RT3DE-guided injections. LV function was assessed before and after injection. Infarct dimension and vascular density were evaluated histologically. RT3DE-guided injection procedures were safe. Compared to controls, the highest dose MPC treatment led to increments in ejection fraction (3±3% in 225M MPCs vs. −5±4% in the control group, p < 0.01) and wall thickening in both infarct (4±4% in 225M MPCs vs. −3±6% in the control group, p = 0.02) and border zones (4±6% in 225M MPCs vs. −8±9% in the control group, p = 0.01). Histology analysis demonstrated significantly higher arteriole density in the infarct and border zones in the highest dose MPC-treated animals compared to the lower dose or control groups. Endomyocardial implantation of MPCs under RT3DE guidance was safe and without observed logistical obstacles. Significant increases in LV performance (ejection fraction and wall thickening) and neovascularization resulted from this technique, and so this technique has important implications for treating patients with postischemic LV dysfunction.

Purpose To assess the effects of local paclitaxel delivery using the Remedy catheter on neointimal hyperplasia in a porcine model and compare these results to commercially available BMS and biodegradable polymer-coated paclitaxel-eluting stents (BP-PES). Methods and materials A total of 31 stents were implanted into coronary arteries of 15 domestic swine including eight BMS, six BP-PES, and 17 BMS after intravasal paclitaxel delivery at doses of 250 μg (LPD250; n =9) and 500 μg (LPD500, n =6). All stents were implanted under quantitative coronary angiography (QCA) guidance to achieve a balloon/artery diameter ratio of 1.15:1.0. Twenty-eight days after the procedure, follow-up coronary angiography was performed, the animals were euthanized, and the coronary arteries harvested for histopathological analysis. Results At follow-up, QCA analysis revealed that lumen loss was significantly worse in BMS and in both LPD groups in comparison to BP-PES stents ( P =.02). Histomorphometric analysis showed that the LPD500 group presented the highest percentage of area stenosis, achieving a statistically significant difference in comparison to BMS and BP-PES stents. Conclusion Our study demonstrates that local paclitaxel delivery using the Remedy transport catheter in the two studied doses (250 and 500 μg) is not effective at neointimal hyperplasia inhibition.

Spectrin and ankyrin participate in membrane organization, stability, signal transduction, and protein targeting; their interaction is critical for erythrocyte stability. Repeats 14 and 15 of βI-spectrin are crucial for ankyrin recognition, yet the way spectrin binds ankyrin while preserving its repeat structure is unknown. We have solved the crystal structure of the βI-spectrin 14,15 di-repeat unit to 2.1 Å resolution and found 14 residues critical for ankyrin binding that map to the end of the helix C of repeat 14, the linker region, and the B-C loop of repeat 15. The tilt (64°) across the 14,15 linker is greater than in any published di-repeat structure, suggesting that the relative positioning of the two repeats is important for ankyrin binding. We propose that a lack of structural constraints on linker and inter-helix loops allows proteins containing spectrin-like di-repeats to evolve diverse but specific ligand-recognition sites without compromising the structure of the repeat unit. The linker regions between repeats are thus critical determinants of both spectrin's flexibility and polyfunctionality. The putative coupling of flexibility and ligand binding suggests a mechanism by which spectrin might participate in mechanosensory regulation.

Purpose Almost 50,000 mitral valve operations are performed annually in the United States, with an increasing number of repairs. Recently, a percutaneous mitral valve repair option that achieves edge-to-edge approximation with a clip has been described in patients with mitral regurgitation. Description We describe 6 patients from three centers with mitral regurgitation after percutaneous repair who underwent reintervention. During open surgical revision, the clips were uneventfully removed in all patients with no limitation in surgical options. Five patients underwent repair and 1 underwent replacement. Evaluation After surgical revision, mitral regurgitation was significantly decreased, and all but 1 patient underwent uneventful recovery. One patient developed ilio-femoral deep venous thrombosis that was treated successfully with anticoagulation. Conclusions Preserving standard of care options is critical with any evolving technology in the event of initial treatment failure. Standard surgical options were preserved in all of the patients who underwent percutaneous mitral valve edge-to-edge repair. Furthermore, a thorough understanding of the clip design, in particular its unlocking mechanism, is essential and facilitates surgical clip removal.

Most of the validation work regarding Paclitaxel Coated Balloon (PCB) technologies has been performed in the coronary territory of juvenile domestic swine. Although invaluable for the evaluation of safety, this model is not properly suited for the evaluation of efficacy of peripheral PCB

ObjectiveThe loss of normal apical rotation is associated with left ventricular (LV) remodeling and systolic dysfunction in patients with congestive heart failure after myocardial infarction. The objective of the present study was to evaluate the effect of epicardial ventricular reconstruction, an off-pump, less-invasive surgical reshaping technique, on myocardial strain, LV twist, and the potential alteration of myocardial fiber orientation in an ovine model of LV anteroapical aneurysm.MethodsLV anteroapical myocardial infarction was induced by coil embolization of the left anterior descending artery. Eight weeks after occlusion, epicardial ventricular reconstruction was performed using left thoracotomy under fluoroscopic guidance in 8 sheep to completely exclude the scar. The peak systolic longitudinal/circumferential strains and LV twist were evaluated using speckle tracking echocardiography before (baseline), after device implantation, and at 6 weeks of follow-up.ResultsEpicardial ventricular reconstruction was completed in all sheep without any complications. Immediately after device implantation, LV twist significantly increased (4.18 ± 1.40 vs baseline 1.97 ± 1.92; P = .02). The ejection fraction had increased 17% and LV end-systolic volume had decreased 40%. The global longitudinal strain increased from −5.3% to −9.1% (P