Objective
The ‘Detroit Cardiogenic Shock Initiative’ is a single‐arm, multicenter study to assess the feasibility of early mechanical circulatory support (MCS) in patients who present with acute ...myocardial infarction complicated by cardiogenic shock (AMICS) who undergo percutaneous coronary intervention.
Methods
Between July 2016 and February 2017, 4 metro Detroit sites participated in the study. The centers agreed to treat patients with AMICS using a mutually agreed‐upon protocol emphasizing invasive hemodynamic monitoring and rapid initiation of MCS. Inclusion and exclusion criteria mimicked those from the ‘SHOCK’ trial with an additional exclusion criteria being use of intra‐aortic balloon pump counter pulsation prior to MCS.
Results
A total of 41 consecutive patients were included. Patients had an average age of 65 ± 14 years, 71% were male and 59% of patients were admitted to the hospital in cardiogenic shock. Prior to receiving MCS, 93% of patients were on vasopressors or inotropes, 15% of patients had a witnessed out of hospital cardiac arrest, 27% of patients had an in‐hospital cardiac arrest, and 17% were under active cardiopulmonary resuscitation while MCS was being implanted. In accordance to the protocol recommendation, 66% of patients had a MCS device inserted prior to PCI. Right heart catheterization and hemodynamic monitoring was performed in 83% of patients. Door to support times averaged 83 ± 58 minutes and 71% of patients were able to reduce the levels of inotropes and vasopressors within the first 24‐hours of their index procedure. Pre‐procedure cardiac power output (CPO) was 0.57 W and post‐procedure CPO was 0.95 W, a 67% increase (p < 0.001). Survival to explant for the entire cohort was 85% a significant improvement from institutional historical controls (85% vs 51% p < 0.001) and survival to discharge was 76%.
Conclusion
Centers who adopted a regional shock protocol emphasizing the delivery of early MCS with invasive hemodynamic monitoring can achieve rapid door to support times and can improve survival in patients who present with AMICS. Larger national studies will be needed to further validate this pilot feasibility study.
Abstract The role and timing of percutaneous mechanical circulatory support (MCS) devices in the treatment of acute myocardial infarction complicated by cardiogenic shock (AMICS) is not well ...understood. We sought to evaluate patient characteristics and predictors of outcomes in patients presenting with AMICS supported with an axial flow percutaneous MCS device. 287 consecutive unselected patients enrolled in the cVAD Registry presenting with AMICS who underwent percutaneous coronary intervention (PCI) were included in this analysis. All patients were supported with either the Impella 2.5 or Impella CP. Mean patient age was 66±12.5 years, 76% were male, mean left ventricular ejection fraction was 25 ±12 %. Prior to receiving MCS, 80% of patients required inotropes or vasopressors and 40% were supported with intra-aortic balloon pump. 9% of patients were under active cardiopulmonary resuscitation at the time of MCS implantation. Survival to discharge was 44%. In a multivariate analysis early implantation of a MCS device prior to PCI (p=0.04) and prior to requiring inotropes and vasopressors (p=0.05) was associated with increased survival. Survival was 66% when MCS was initiated <1.25 hours from shock onset, 37% when initiated within 1.25-4.25 hours, and 26% when initiated after 4.25 hours (p=0.017). Survival was 68%, 46%, 35%, 35%, 26% for patients requiring 0, 1, 2, 3, ≥4 inotropes prior to MCS support respectively (P<0.001). In conclusion, MCS implantation early after shock onset, before initiation of inotropes or vasopressors and prior to PCI, is independently associated with improved survival in patients presenting with AMICS.
The Impella percutaneous ventricular assist device (PVAD) rapidly deploys mechanical circulatory support (MCS) in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS). ...We present findings from a quality improvement (IQ) registry for US patients with AMICS who received Impella devices.
From January 2009 to December 2016, 46,949 patients from 1010US hospitals were entered into the IQ registry; of these, 15,259 had AMICS. Limited de-identified patient information, product performance, and survival to explantation were recorded. Of those with AMICS, 51% survived to explantation of PVAD. There was a significant difference between survival at explantation with quintile volume at hospitals (range: 0–100%; 30% survival rate in lowest quintile vs. 76% in top quintile; P<.0001). Use of the Impella device as first-line treatment pre-PCI was associated with a 59% survival rate, compared with 52% when used as a salvage strategy (P<.001). The survival rate among those who received hemodynamic monitoring with pulmonary artery catheters was 63% as compared with 49% in those who did not (P<.0001). Overall institutional Impella volume was related to survival (56% survival at sites with >7/year vs. 51% at sites with ≤1; P<.001).
In this early clinical experience with Impella support for AMICS, wide variation in outcomes existed across centers. Survival was higher when Impella was used as first support strategy, when invasive hemodynamic monitoring was used, and at centers with higher Impella implantation volume.
Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension.
We designed a prospective, single-blind, ...randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. Before randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. The primary efficacy end point was the change in office systolic blood pressure at 6 months; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months.
A total of 535 patients underwent randomization. The mean (±SD) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group (P<0.001 for both comparisons of the change from baseline), for a difference of -2.39 mm Hg (95% confidence interval CI, -6.89 to 2.12; P=0.26 for superiority with a margin of 5 mm Hg). The change in 24-hour ambulatory systolic blood pressure was -6.75±15.11 mm Hg in the denervation group and -4.79±17.25 mm Hg in the sham-procedure group, for a difference of -1.96 mm Hg (95% CI, -4.97 to 1.06; P=0.98 for superiority with a margin of 2 mm Hg). There were no significant differences in safety between the two groups.
This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control. (Funded by Medtronic; SYMPLICITY HTN-3 ClinicalTrials.gov number, NCT01418261.).
Objective
Demonstrate proof‐of‐concept validation of a computed tomography (CT) computer‐aided design prediction modeling tool to identify patients at risk for left ventricular outflow tract (LVOT) ...obstruction in transcatheter mitral valve replacement (TMVR).
Background
LVOT obstruction is a significant and even fatal consequence of TMVR.
Methods
From August 2013 to August 2017, 38 patients in 5 centers underwent TMVR with compassionate use of balloon‐expandable valves for severe mitral valve dysfunction because of degenerative surgical mitral ring, bioprosthesis, or severe native mitral stenosis from to severe mitral annular calcification. All patients had preprocedural CT scans performed for anatomic screening, intraprocedural TEE and invasive hemodynamics performed. Preprocedural prediction modeling was performed utilizing computer‐aided design (CAD) of the neo‐LVOT post‐TMVR. Post‐TMVR CT scans were obtained and compared to pre‐TMVR LVOT modeling datasets for validation.
Results
All patients underwent successful TMVR without device embolization. Seven of the 38 patients experienced LVOT obstruction, defined as an increase of ≥10 mmHg LVOT peak gradient post‐TMVR. Anatomic screening using CT was validated in 20/38 patients as preprocedural predicted neo‐LVOT surface area correlated well with post‐TMVR measurements (R2 = 0.8169, P < 0.0001). A receiver operating curve curve found a predicted neo‐LVOT surface area of ≤ 189.4 mm2 to have 100% sensitivity and 96.8% specificity for predicting TMVR‐induced LVOT obstruction.
Conclusion
CAD design and CT postprocessing are indispensable tools in predicting LVOT obstruction and necessary for anatomic screening in percutaneous TMVR.
The ventriloquism aftereffect (VAE) refers to a shift in auditory spatial perception following exposure to a spatial disparity between auditory and visual stimuli. The VAE has been previously ...measured on two distinct time scales. Hundreds or thousands of exposures to a an audio-visual spatial disparity produces enduring VAE that persists after exposure ceases. Exposure to a single audio-visual spatial disparity produces immediate VAE that decays over seconds. To determine if these phenomena are two extremes of a continuum or represent distinct processes, we conducted an experiment with normal hearing listeners that measured VAE in response to a repeated, constant audio-visual disparity sequence, both immediately after exposure to each audio-visual disparity and after the end of the sequence. In each experimental session, subjects were exposed to sequences of auditory and visual targets that were constantly offset by +8° or -8° in azimuth from one another, then localized auditory targets presented in isolation following each sequence. Eye position was controlled throughout the experiment, to avoid the effects of gaze on auditory localization. In contrast to other studies that did not control eye position, we found both a large shift in auditory perception that decayed rapidly after each AV disparity exposure, along with a gradual shift in auditory perception that grew over time and persisted after exposure to the AV disparity ceased. We modeled the temporal and spatial properties of the measured auditory shifts using grey box nonlinear system identification, and found that two models could explain the data equally well. In the power model, the temporal decay of the ventriloquism aftereffect was modeled with a power law relationship. This causes an initial rapid drop in auditory shift, followed by a long tail which accumulates with repeated exposure to audio-visual disparity. In the double exponential model, two separate processes were required to explain the data, one which accumulated and decayed exponentially and the other which slowly integrated over time. Both models fit the data best when the spatial spread of the ventriloquism aftereffect was limited to a window around the location of the audio-visual disparity. We directly compare the predictions made by each model, and suggest additional measurements that could help distinguish which model best describes the mechanisms underlying the VAE.
•As of May 27, 2020 there are over 1,678,843 confirmed cases of COVID-19 claiming more than 100,000 lives in the Unites States. Currently there is no known effective therapy or vaccine.•According to ...a protocol-based treatment algorithm, among hospitalized patients, use of hydroxychloroquine alone and in combination with azithromycin was associated with a significant reduction in-hospital mortality compared to not receiving hydroxychloroquine.•Findings of this observational study provide crucial data on experience with hydroxychloroquine therapy, providing necessary interim guidance for COVID-19 therapeutic practice.
The United States is in an acceleration phase of the COVID-19 pandemic. Currently there is no known effective therapy or vaccine for treatment of SARS-CoV-2, highlighting urgency around identifying effective therapies.
The purpose of this study was to evaluate the role of hydroxychloroquine therapy alone and in combination with azithromycin in hospitalized patients positive for COVID-19.
Multi-center retrospective observational study.
The Henry Ford Health System (HFHS) in Southeast Michigan: large six hospital integrated health system; the largest of hospitals is an 802-bed quaternary academic teaching hospital in urban Detroit, Michigan.
Consecutive patients hospitalized with a COVID-related admission in the health system from March 10, 2020 to May 2, 2020 were included. Only the first admission was included for patients with multiple admissions. All patients evaluated were 18 years of age and older and were treated as inpatients for at least 48h unless expired within 24h.
Receipt of hydroxychloroquine alone, hydroxychloroquine in combination with azithromycin, azithromycin alone, or neither.
The primary outcome was in-hospital mortality.
Of 2,541 patients, with a median total hospitalization time of 6 days (IQR: 4–10 days), median age was 64 years (IQR:53–76 years), 51% male, 56% African American, with median time to follow-up of 28.5 days (IQR:3–53). Overall in-hospital mortality was 18.1% (95% CI:16.6%–19.7%); by treatment: hydroxychloroquine+azithromycin, 157/783 (20.1% 95% CI: 17.3%–23.0%), hydroxychloroquine alone, 162/1202 (13.5% 95% CI: 11.6%–15.5%), azithromycin alone, 33/147 (22.4% 95% CI: 16.0%–30.1%), and neither drug, 108/409 (26.4% 95% CI: 22.2%–31.0%). Primary cause of mortality was respiratory failure (88%); no patient had documented torsades de pointes. From Cox regression modeling, predictors of mortality were age>65 years (HR:2.6 95% CI:1.9–3.3), white race (HR:1.7 95% CI:1.4–2.1), CKD (HR:1.7 95%CI:1.4–2.1), reduced O2 saturation level on admission (HR:1.5 95%CI:1.1–2.1), and ventilator use during admission (HR: 2.2 95%CI:1.4–3.3). Hydroxychloroquine provided a 66% hazard ratio reduction, and hydroxychloroquine+azithromycin 71% compared to neither treatment (p<0.001).
In this multi-hospital assessment, when controlling for COVID-19 risk factors, treatment with hydroxychloroquine alone and in combination with azithromycin was associated with reduction in COVID-19 associated mortality. Prospective trials are needed to examine this impact.
In Reimagining Human Rights, William O'Neill presents an interpretation of human rights "from below, " showing how victims of atrocity can embrace the rhetoric of human rights to dismantle old ...narratives of power and advance new ones. Topics covered include race and mass incarceration, immigration and refugee policy, and ecological responsibility.
Objectives
To evaluate the periprocedural characteristics and outcomes of patients supported with Impella 2.5 prior to percutaneous coronary intervention (pre‐PCI) versus those who received it after ...PCI (post‐PCI) in the setting of cardiogenic shock (CS) complicating an acute myocardial infarction (AMI).
Background
Early mechanical circulatory support may improve outcome in the setting of CS complicating an AMI. However, the optimal timing to initiate hemodynamic support has not been well characterized.
Methods
Data from 154 consecutive patients who underwent PCI and Impella 2.5 support from 38 US hospitals participating in the USpella Registry were included in our study. The primary end‐point was survival to discharge. Secondary end‐points included assessment of patients' hemodynamics and in‐hospital complications. A multivariate regression model was used to identify independent predictors for mortality.
Results
Both groups were comparable except for diabetes (P = 0.02), peripheral vascular disease (P = 0.008), chronic obstructive pulmonary disease (P = 0.05), and prior stroke (P = 0.04), all of which were more prevalent in the pre‐PCI group. Patients in the pre‐PCI group had more lesions (P = 0.006) and vessels (P = 0.01) treated. These patients had also significantly better survival to discharge compared to patients in the post‐PCI group (65.1% vs.40.7%, P = 0.003). Survival remained favorable for the pre‐PCI group after adjusting for potential confounding variables. Initiation of support prior to PCI with Impella 2.5 was an independent predictor of in‐hospital survival (Odds ratio 0.37, 95% confidence interval: 0.17–0.79, P = 0.01) in multivariate analysis. The incidence of in‐hospital complications included in the secondary end‐point was similar between the 2 groups.
Conclusions
The results of our study suggest that early initiation of hemodynamic support prior to PCI with Impella 2.5 is associated with more complete revascularization and improved survival in the setting of refractory CS complicating an AMI. (J Interven Cardiol 2014;27:1–11)
Background
The National Cardiogenic Shock Initiative is a single‐arm, prospective, multicenter study to assess outcomes associated with early mechanical circulatory support (MCS) in patients ...presenting with acute myocardial infarction and cardiogenic shock (AMICS) treated with percutaneous coronary intervention (PCI).
Methods
Between July 2016 and February 2019, 35 sites participated and enrolled into the study. All centers agreed to treat patients with AMICS using a standard protocol emphasizing invasive hemodynamic monitoring and rapid initiation of MCS. Inclusion and exclusion criteria mimicked those of the “SHOCK” trial with an additional exclusion criteria of intra‐aortic balloon pump counter‐pulsation prior to MCS.
Results
A total of 171 consecutive patients were enrolled. Patients had an average age of 63 years, 77% were male, and 68% were admitted with AMICS. About 83% of patients were on vasopressors or inotropes, 20% had a witnessed out of hospital cardiac arrest, 29% had in‐hospital cardiac arrest, and 10% were under active cardiopulmonary resuscitation during MCS implantation. In accordance with the protocol, 74% of patients had MCS implanted prior to PCI. Right heart catheterization was performed in 92%. About 78% of patients presented with ST‐elevation myocardial infarction with average door to support times of 85 ± 63 min and door to balloon times of 87 ± 58 min.
Survival to discharge was 72%. Creatinine ≥2, lactate >4, cardiac power output (CPO) <0.6 W, and age ≥ 70 years were predictors of mortality. Lactate and CPO measurements at 12–24 hr reliably predicted overall mortality postindex procedure.
Conclusion
In contemporary practice, use of a shock protocol emphasizing best practices is associated with improved outcomes.
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