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1.
Am J Cardiol ; 215: 19-27, 2024 Mar 15.
Article in English | MEDLINE | ID: mdl-38266797

ABSTRACT

Limited data exist regarding outcomes after coronary angiography (CAG) and percutaneous coronary intervention (PCI) in patients aged ≥90 years admitted to the cardiac intensive care unit (CICU) with acute coronary syndrome (ACS). We studied sequential CICU patients ≥90 years admitted with ACS from 2007 to 2018. Three therapeutic approaches were defined: (1) No CAG; (2) CAG without PCI (CAG/No PCI); and (3) CAG with PCI (CAG/PCI). In-hospital mortality was evaluated using multivariable logistic regression. All-cause 1-year mortality was evaluated using Kaplan-Meier and multivariable Cox proportional hazards analysis. The study included 239 patients with a median age of 92 (range 90 to 100) years (57% females; 45% ST-elevation myocardial infarction; 8% cardiac arrest; 16% shock). The No CAG group had higher Day 1 Sequential Organ Failure Assessment scores, more co-morbidities, worse kidney function, and fewer ST-elevation myocardial infarctions. In-hospital mortality was 20.8% overall and did not differ between the No CAG (n = 103; 21.4%), CAG/No PCI (n = 47; 21.3%), and CAG/PCI (n = 90; 20.0%) groups, before or after adjustment. Overall 1-year mortality was 52.5% and did not differ between groups before or after adjustment. Median survival was 6.9 months overall and 41.2% of hospital survivors died within 1 year of CICU admission. CICU patients aged ≥90 years with ACS have a substantial burden of illness with high in-hospital and 1-year mortality that was not lower in those who underwent CAG or PCI. These results suggest that careful patient selection for invasive coronary procedures is essential in this vulnerable population.


Subject(s)
Acute Coronary Syndrome , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Female , Humans , Aged, 80 and over , Male , Acute Coronary Syndrome/surgery , Heart , Intensive Care Units , Coronary Angiography , ST Elevation Myocardial Infarction/surgery
2.
J Invasive Cardiol ; 36(1)2024 Jan.
Article in English | MEDLINE | ID: mdl-38224294

ABSTRACT

OBJECTIVES: Early coronary angiography (CAG) has been recommended in selected patients following out-of-hospital-cardiac-arrest (OHCA). We aimed to identify clinical features associated with acute coronary occlusion (ACO) and evaluate the associations between ACO, successful percutaneous coronary intervention (PCI) and outcomes in this population. METHODS: We included comatose OHCA patients treated with targeted temperature management (TTM) between December 2005 and September 2016 who underwent early CAG within 24 hours. The co-primary outcomes were all-cause 30-day mortality and good neurological outcome (modified Rankin Score [mRS] ≤2) at hospital discharge. RESULTS: Among 155 patients (93% shockable arrest rhythm, 55% with ST elevation), 133 (86%) had coronary artery stenosis ≥50% and 65 (42%) had ACO. ST elevation (sensitivity 74%, specificity 59%, OR 4.0, 95% CI 2.0-8.1) and elevated first troponin (sensitivity 88%, specificity 26%, OR 2.5, 95% CI 1.1-6.1) had limited sensitivity and specificity for ACO. Unadjusted 30-day mortality did not differ significantly by coronary disease severity or ACO. Successful PCI was associated with a lower risk of 30-day mortality (adjusted HR 0.5, 95% CI 0.2-0.9, P=.03), especially among patients with ACO (adjusted HR 0.4, 95% CI 0.1-0.9, P=0.03). After adjustment, ACO and PCI were not associated with the probability of good neurological outcome. CONCLUSIONS: In this select cohort of resuscitated OHCA patients undergoing CAG, unstable coronary disease is highly prevalent and successful PCI was associated with a higher probability of 30-day survival, especially among those with ACO. Neither ACO nor successful PCI were independently associated with good neurological outcome.


Subject(s)
Coronary Artery Disease , Coronary Occlusion , Out-of-Hospital Cardiac Arrest , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Humans , Coronary Occlusion/diagnosis , Coronary Occlusion/surgery , Out-of-Hospital Cardiac Arrest/diagnosis , Out-of-Hospital Cardiac Arrest/etiology , Out-of-Hospital Cardiac Arrest/therapy , Heart
3.
J Med Internet Res ; 25: e47475, 2023 11 10.
Article in English | MEDLINE | ID: mdl-37948098

ABSTRACT

BACKGROUND: Accurate, timely ascertainment of clinical end points, particularly hospitalizations, is crucial for clinical trials. The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study extended the main TAILOR-PCI trial's follow-up to 2 years, using a smartphone-based research app featuring geofencing-triggered surveys and routine monthly mobile phone surveys to detect cardiovascular (CV) hospitalizations. This pilot study compared these digital tools to conventional site-coordinator ascertainment of CV hospitalizations. OBJECTIVE: The objectives were to evaluate geofencing-triggered notifications and routine monthly mobile phone surveys' performance in detecting CV hospitalizations compared to telephone visits and health record reviews by study coordinators at each site. METHODS: US and Canadian participants from the TAILOR-PCI Digital Follow-Up Study were invited to download the Eureka Research Platform mobile app, opting in for location tracking using geofencing, triggering a smartphone-based survey if near a hospital for ≥4 hours. Participants were sent monthly notifications for CV hospitalization surveys. RESULTS: From 85 participants who consented to the Digital Study, downloaded the mobile app, and had not previously completed their final follow-up visit, 73 (85.8%) initially opted in and consented to geofencing. There were 9 CV hospitalizations ascertained by study coordinators among 5 patients, whereas 8 out of 9 (88.9%) were detected by routine monthly hospitalization surveys. One CV hospitalization went undetected by the survey as it occurred within two weeks of the previous event, and the survey only allowed reporting of a single hospitalization. Among these, 3 were also detected by the geofencing algorithm, but 6 out of 9 (66.7%) were missed by geofencing: 1 occurred in a participant who never consented to geofencing, while 5 hospitalizations occurred among participants who had subsequently turned off geofencing prior to their hospitalization. Geofencing-detected hospitalizations were ascertained within a median of 2 (IQR 1-3) days, monthly surveys within 11 (IQR 6.5-25) days, and site coordinator methods within 38 (IQR 9-105) days. The geofencing algorithm triggered 245 notifications among 39 participants, with 128 (52.2%) from true hospital presence and 117 (47.8%) from nonhospital health care facility visits. Additional geofencing iterative improvements to reduce hospital misidentification were made to the algorithm at months 7 and 12, elevating the rate of true alerts from 35.4% (55 true alerts/155 total alerts before month 7) to 78.7% (59 true alerts/75 total alerts in months 7-12) and ultimately to 93.3% (14 true alerts/5 total alerts in months 13-21), respectively. CONCLUSIONS: The monthly digital survey detected most CV hospitalizations, while the geofencing survey enabled earlier detection but did not offer incremental value beyond traditional tools. Digital tools could potentially reduce the burden on study coordinators in ascertaining CV hospitalizations. The advantages of timely reporting via geofencing should be weighed against the issue of false notifications, which can be mitigated through algorithmic refinements.


Subject(s)
Percutaneous Coronary Intervention , Humans , Clopidogrel/therapeutic use , Follow-Up Studies , Pilot Projects , Canada , Hospitalization
6.
JACC Cardiovasc Interv ; 16(7): 816-825, 2023 04 10.
Article in English | MEDLINE | ID: mdl-37045502

ABSTRACT

BACKGROUND: Genetic-guided P2Y12 inhibitor selection has been proposed to reduce ischemic events by identifying CYP2C19 loss-of-function (LOF) carriers at increased risk with clopidogrel treatment after percutaneous coronary intervention (PCI). A prespecified analysis of TAILOR-PCI (Tailored Antiplatelet Therapy Following PCI) evaluated the effect of genetic-guided P2Y12 inhibitor therapy on cumulative ischemic and bleeding events. OBJECTIVES: Here, the authors detail a prespecified analysis of cumulative endpoints. The primary endpoint was cumulative incidence rate of ischemic events at 12 months. Cumulative incidence of major and minor bleeding was a secondary endpoint. Cox proportional hazards models as adapted by Wei, Lin, and Weissfeld were used to estimate the effect of this strategy on all observed events. METHODS: The TAILOR-PCI trial was a prospective trial including 5,302 post-PCI patients with acute and stable coronary artery disease (CAD) who were randomized to genetic-guided P2Y12 inhibitor or conventional clopidogrel therapy. In the genetic-guided group, LOF carriers were prescribed ticagrelor, whereas noncarriers received clopidogrel. TAILOR-PCI's primary analysis was time to first event in LOF carriers. RESULTS: Among 5,276 patients (median age 62 years; 25% women; 82% acute CAD; 18% stable CAD), 1,849 were LOF carriers (903 genetic-guided; 946 conventional therapy). The cumulative primary endpoint was significantly reduced in the genetic-guided group compared with the conventional therapy (HR: 0.61; 95% CI: 0.41-0.89; P = 0.011) with no significant difference in cumulative incidence of major or minor bleeding (HR: 1.36; 95% CI: 0.67-2.76; P = 0.39). CONCLUSIONS: Among CYP2C19 LOF carriers undergoing PCI, a genetic-guided strategy resulted in a statistically significant reduction in cumulative ischemic events without a significant difference in bleeding. (Tailored Antiplatelet Therapy Following PCI [TAILOR-PCI]; NCT01742117).


Subject(s)
Acute Coronary Syndrome , Coronary Artery Disease , Percutaneous Coronary Intervention , Humans , Female , Middle Aged , Male , Clopidogrel/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Cytochrome P-450 CYP2C19/genetics , Percutaneous Coronary Intervention/adverse effects , Prospective Studies , Treatment Outcome , Hemorrhage/etiology , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Coronary Artery Disease/complications , Acute Coronary Syndrome/therapy , Purinergic P2Y Receptor Antagonists/adverse effects
8.
Circ Cardiovasc Interv ; 15(7): e011540, 2022 07.
Article in English | MEDLINE | ID: mdl-35861796

ABSTRACT

BACKGROUND: Previous percutaneous coronary intervention risk models were focused on single outcome, such as mortality or bleeding, etc, limiting their applicability. Our objective was to develop contemporary percutaneous coronary intervention risk models that not only determine in-hospital mortality but also predict postprocedure bleeding, acute kidney injury, and stroke from a common set of variables. METHODS: We built risk models using logistic regression from first percutaneous coronary intervention for any indication per patient (n=19 322, 70.6% with acute coronary syndrome) using the Mayo Clinic registry from January 1, 2000 to December 31, 2016. Approval for the current study was obtained from the Mayo Foundation Institutional Review Board. Patients with missing outcomes (n=4183) and those under 18 (n=10) were removed resulting in a sample of 15 129. We built both models that included procedural and angiographic variables (Models A) and precatheterization model (Models B). RESULTS: Death, bleeding, acute kidney injury, and stroke occurred in 247 (1.6%), 650 (4.3%), 1184 (7.8%), and 67 (0.4%), respectively. The C statistics from the test dataset for models A were 0.92, 0.70, 0.77, and 0.71 and for models B were 0.90, 0.67, 0.76, and 0.71 for in-hospital death, bleeding, acute kidney injury, and stroke, respectively. Bootstrap analysis indicated that the models were not overfit to the available dataset. The probabilities estimated from the models matched the observed data well, as indicated by the calibration curves. The models were robust across many subgroups, including women, elderly, acute coronary syndrome, cardiogenic shock, and diabetes. CONCLUSIONS: The new risk scoring models based on precatheterization variables and models including procedural and angiographic variables accurately predict in-hospital mortality, bleeding, acute kidney injury, and stroke. The ease of its application will provide useful prognostic and therapeutic information to both patients and physicians.


Subject(s)
Acute Coronary Syndrome , Acute Kidney Injury , Percutaneous Coronary Intervention , Stroke , Acute Coronary Syndrome/diagnostic imaging , Acute Coronary Syndrome/therapy , Acute Kidney Injury/diagnosis , Acute Kidney Injury/epidemiology , Aged , Female , Hemorrhage , Hospital Mortality , Humans , Multimorbidity , Percutaneous Coronary Intervention/adverse effects , Registries , Risk Assessment , Risk Factors , Stroke/diagnosis , Stroke/epidemiology , Treatment Outcome
9.
JMIR Form Res ; 6(6): e34080, 2022 Jun 13.
Article in English | MEDLINE | ID: mdl-35699977

ABSTRACT

BACKGROUND: The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study is a novel proof-of-concept study that evaluated the feasibility of extending the TAILOR-PCI randomized controlled trial (RCT) follow-up period by using a remote digital platform. OBJECTIVE: The aim of this study is to describe patients' onboarding, engagement, and results in a digital study after enrollment in an RCT. METHODS: In this intervention study, previously enrolled TAILOR-PCI patients in the United States and Canada within 24 months of randomization were invited by letter to download the study app. Those who did not respond to the letter were contacted by phone to survey the reasons for nonparticipation. A direct-to-patient digital research platform (the Eureka Research Platform) was used to onboard patients, obtain consent, and administer activities in the digital study. The patients were asked to complete health-related surveys and digitally provide follow-up data. Our primary end points were the consent rate, the duration of participation, and the monthly activity completion rate in the digital study. The hypothesis being tested was formulated before data collection began. RESULTS: After the parent trial was completed, letters were mailed to 907 eligible patients (representing 18.8% [907/4837] of total enrolled in the RCT) within 15.6 (SD 5.2) months of randomization across 24 sites. Among the 907 patients invited, 290 (32%) visited the study website and 110 (12.1%) consented-40.9% (45/110) after the letter, 33.6% (37/110) after the first phone call, and 25.5% (28/110) after the second call. Among the 47.4% (409/862) of patients who responded, 41.8% (171/409) declined to participate because of a lack of time, 31.2% (128/409) declined because of the lack of a smartphone, and 11.5% (47/409) declined because of difficulty understanding what was expected of them in the study. Patients who consented were older (aged 65.3 vs 62.5 years; P=.006) and had a lower prevalence of diabetes (19% vs 30%; P=.02) or tobacco use (6.4% vs 24.8%; P<.001). A greater proportion had bachelor's degrees (47.2% vs 25.7%; P<.001) and were more computer literate (90.5% vs 62.3% of daily internet use; P<.001) than those who did not consent. The average completion rate of the 920 available monthly electronic visits was 64.9% (SD 7.6%); there was no decrease in this rate throughout the study duration. CONCLUSIONS: Extended follow-up after enrollment in an RCT by using a digital study was technically feasible but was limited because of the inability to contact most eligible patients or a lack of time or access to a smartphone. Among the enrolled patients, most completed the required electronic visits. Enhanced recruitment methods, such as the introduction of a digital study at the time of RCT consent, smartphone provision, and robust study support for onboarding, should be explored further. TRIAL REGISTRATION: Clinicaltrails.gov NCT01742117; https://clinicaltrials.gov/ct2/show/NCT01742117.

10.
J Invasive Cardiol ; 34(5): E356-E362, 2022 05.
Article in English | MEDLINE | ID: mdl-35501112

ABSTRACT

BACKGROUND: The safety and feasibility of radial access in patients undergoing percutaneous coronary intervention (PCI) prior to transcatheter aortic valve replacement (TAVR) has not been studied. METHODS: This study included consecutive patients who underwent PCI within 30 days before TAVR at Mayo Clinic. Vascular access was left to the discretion of the operator. Baseline demographics, procedural data, PCI outcomes, and subsequent transfemoral TAVR outcomes were extracted from patient charts. RESULTS: A total of 331 patients were included in this study, with 107 patients undergoing PCI via radial access (rPCI), and 224 via femoral access (fPCI). Mean age was 80.6 years and 35.6% were females (35.5% rPCI vs 35.3% fPCI). More patients in the fPCI group had previous coronary artery bypass graft surgery (13.1% rPCI vs 34.4% fPCI; P<.001). Fluoroscopy time (13.36 minutes vs 18.86 minutes; P<.001) and contrast use (115 mL vs 140 mL; P<.01) were lower in the rPCI group than in the fPCI group. Crossover rate from radial to femoral was 6.5%. There were more access-site hematomas in the fPCI group (2.8% rPCI vs 14.3% fPCI; P<.001), with no statistically significant rate of other access-related complications. There was no difference in stroke, myocardial infarction, cardiac arrest, or unplanned surgery. There was no difference in bleeding or stroke between both groups during subsequent transfemoral TAVR. CONCLUSION: Radial access for pre-TAVR PCI is feasible and safe and is associated with a lower rate of access-site hematoma. This study supports the increased use of transradial access for pre-TAVR PCI.


Subject(s)
Aortic Valve Stenosis , Percutaneous Coronary Intervention , Stroke , Transcatheter Aortic Valve Replacement , Aged, 80 and over , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/surgery , Female , Fluoroscopy , Humans , Male , Percutaneous Coronary Intervention/adverse effects , Stroke/etiology , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
11.
Circ Heart Fail ; 15(5): e008991, 2022 05.
Article in English | MEDLINE | ID: mdl-35240866

ABSTRACT

BACKGROUND: There are limited data on uninsured patients presenting with acute myocardial infarction-cardiogenic shock (AMI-CS). This study sought to compare the management and outcomes of AMI-CS between uninsured and privately insured individuals. METHODS: Using the National Inpatient Sample (2000-2016), a retrospective cohort of adult (≥18 years) uninsured admissions (primary payer-self-pay or no charge) were compared with privately insured individuals. Interhospital transfers were excluded. Outcomes of interest included in-hospital mortality, temporal trends in admissions, use of cardiac procedures, do-not-resuscitate status, palliative care referrals, and resource utilization. RESULTS: Of 402 182 AMI-CS admissions, 21 966 (5.4%) and 93 814 (23.3%) were uninsured and privately insured. Compared with private insured individuals, uninsured admissions were younger, male, from a lower socioeconomic status, had lower comorbidity, higher rates of acute organ failure, ST-segment elevation AMI-CS (77.3% versus 76.4%), and concomitant cardiac arrest (33.8% versus 31.9%; all P<0.001). Compared with 2000, in 2016, there were more uninsured (adjusted odds ratio, 1.15 [95% CI, 1.13-1.17]; P<0.001) and less privately insured admissions (adjusted odds ratio, 0.85 [95% CI, 0.83-0.87]; P<0.001). Uninsured individuals received less frequent coronary angiography (79.5% versus 81.0%), percutaneous coronary intervention (60.8% versus 62.2%), mechanical circulatory support (54% versus 55.5%), and had higher palliative care (3.8% versus 3.2%) and do-not-resuscitate status use (4.4% versus 3.2%; all P<0.001). Uninsured admissions had higher in-hospital mortality (adjusted odds ratio, 1.62 [95% CI, 1.55-1.68]; P<0.001) and resource utilization. CONCLUSIONS: Uninsured individuals have higher in-hospital mortality and lower use of guideline-directed therapies in AMI-CS compared with privately insured individuals.


Subject(s)
Heart Failure , Myocardial Infarction , Adult , Heart Failure/complications , Hospital Mortality , Humans , Insurance, Health , Male , Medically Uninsured , Myocardial Infarction/complications , Myocardial Infarction/diagnosis , Myocardial Infarction/therapy , Retrospective Studies , Shock, Cardiogenic/therapy , United States/epidemiology
12.
Am J Cardiol ; 169: 1-9, 2022 04 15.
Article in English | MEDLINE | ID: mdl-35045934

ABSTRACT

Cardiac arrest (CA) is common and has been associated with adverse outcomes in patients with cardiogenic shock (CS). We sought to determine the prevalence, patient characteristics, and outcomes of CA in cardiovascular intensive care unit patients with CS. We queried cardiovascular intensive care unit admissions from 2007 to 2018 with an admission diagnosis of CS and compared patients with and without CA. Temporal trends were assessed using linear regression. The primary and secondary outcomes of in-hospital and 1-year mortality were analyzed using logistic regression and Cox proportional-hazards analysis, respectively. We included 1,498 patients, and CA was present in 510 patients (34%), with 258 (50.6% of patients with CA) having ventricular fibrillation (VF). Mean age was 68 ± 14 years, and 37% were females. The prevalence of CA decreased over time (from 43% in 2007 to 24% in 2018, p <0.001). Hospital mortality was 33.3% and decreased over time in patients without CA (from 30% in 2007 to 22% in 2018, p = 0.05), but not in patients with CA (p = 0.71). CA was associated with a higher risk of hospital mortality (51.0% vs 24.2%, adjusted odds ratio 2.15, 95% confidence interval [CI] 1.52 to 3.05, p <0.001), with no difference between VF CA and non-VF CA (p = 0.64). CA was associated with higher 1-year mortality (adjusted hazard ratio 1.53, 95% CI 1.24 to 1.89, p <0.001). In conclusion, CA is present in 1 of 3 of CS hospitalizations and confers a substantially higher risk of hospital and 1-year mortality with no improvement during our 12-year study period contrary to prevailing trends.


Subject(s)
Heart Arrest , Shock, Cardiogenic , Aged , Aged, 80 and over , Female , Heart Arrest/diagnosis , Heart Arrest/epidemiology , Heart Arrest/therapy , Hospital Mortality , Humans , Intensive Care Units , Middle Aged , Retrospective Studies
13.
Am Heart J ; 244: 54-65, 2022 02.
Article in English | MEDLINE | ID: mdl-34774802

ABSTRACT

OBJECTIVE: To evaluate the epidemiology and outcomes of non-ST-segment-elevation myocardial infarction-cardiogenic shock (NSTEMI-CS) in the United States. METHODS: Adult (>18 years) NSTEMI-CS admissions were identified using the National Inpatient Sample (2000-2017) and classified by tertiles of admission year (2000-2005, 2006-2011 and 2012-2017). Outcomes of interest included temporal trends of prevalence and in-hospital mortality, use of cardiac procedures, in-hospital mortality, hospitalization costs, and length of stay. RESULTS: In over 7.3 million NSTEMI admissions, CS was noted in 189,155 (2.6%). NSTEMI-CS increased from 1.5% in 2000 to 3.6% in 2017 (adjusted odds ratio 2.03 [95% confidence interval 1.97-2.09]; P < .001). Rates of non-cardiac organ failure and cardiac arrest increased during the study period. Between 2000 and 2017, coronary angiography (43.9%-63.9%), early coronary angiography (13.6%-25.6%), percutaneous coronary intervention (14.8%-31.6%), and coronary artery bypass grafting use (19.0%-25.8%) increased (P < .001). Over the study period, the use of intra-aortic balloon pump remained stable (28.6%-28.8%), and both percutaneous left ventricular assist devices (0%-9.1%) and extra-corporeal membrane oxygenation (0.1%-1.6%) increased (all P < .001). In hospital mortality decreased from 50.2% in 2000 to 32.3% in 2017 (adjusted odds ratio 0.27 [95% confidence interval 0.25-0.29]; P < .001). During the 18-year period, hospital lengths of stay decreased, and hospitalization costs increased. CONCLUSIONS: In the United States, prevalence of CS in NSTEMI has increased 2-fold between 2000 and 2017, while in-hospital mortality has decreased during the study period. Use of coronary angiography and percutaneous coronary intervention increased during the study period.


Subject(s)
Non-ST Elevated Myocardial Infarction , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Adult , Hospital Mortality , Humans , Intra-Aortic Balloon Pumping/adverse effects , Non-ST Elevated Myocardial Infarction/complications , Non-ST Elevated Myocardial Infarction/diagnosis , Non-ST Elevated Myocardial Infarction/epidemiology , Percutaneous Coronary Intervention/adverse effects , ST Elevation Myocardial Infarction/complications , ST Elevation Myocardial Infarction/epidemiology , ST Elevation Myocardial Infarction/therapy , Shock, Cardiogenic/epidemiology , Shock, Cardiogenic/etiology , Shock, Cardiogenic/therapy , United States/epidemiology
14.
Circ Res ; 130(3): 326-338, 2022 02 04.
Article in English | MEDLINE | ID: mdl-34923853

ABSTRACT

BACKGROUND: Coronary endothelial dysfunction (CED) causes angina/ischemia in patients with nonobstructive coronary artery disease (NOCAD). Patients with CED have decreased number and function of CD34+ cells involved in normal vascular repair with microcirculatory regenerative potential and paracrine anti-inflammatory effects. We evaluated safety and potential efficacy of intracoronary autologous CD34+ cell therapy for CED. METHODS: Twenty NOCAD patients with invasively diagnosed CED and persistent angina despite maximally tolerated medical therapy underwent baseline exercise stress test, GCSF (granulocyte colony stimulating factor)-mediated CD34+ cell mobilization, leukapheresis, and selective 1×105 CD34+ cells/kg infusion into left anterior descending. Invasive CED evaluation and exercise stress test were repeated 6 months after cell infusion. Primary end points were safety and effect of intracoronary autologous CD34+ cell therapy on CED at 6 months of follow-up. Secondary end points were change in Canadian Cardiovascular Society angina class, as-needed sublingual nitroglycerin use/day, Seattle Angina Questionnaire scores, and exercise time at 6 months. Change in CED was compared with that of 51 historic control NOCAD patients treated with maximally tolerated medical therapy alone. RESULTS: Mean age was 52±13 years; 75% were women. No death, myocardial infarction, or stroke occurred. Intracoronary CD34+ cell infusion improved microvascular CED (%acetylcholine-mediated coronary blood flow increased from 7.2 [-18.0 to 32.4] to 57.6 [16.3-98.3]%; P=0.014), decreased Canadian Cardiovascular Society angina class (3.7±0.5 to 1.7±0.9, Wilcoxon signed-rank test, P=0.00018), and sublingual nitroglycerin use/day (1 [0.4-3.5] to 0 [0-1], Wilcoxon signed-rank test, P=0.00047), and improved all Seattle Angina Questionnaire scores with no significant change in exercise time at 6 months of follow-up. Historic control patients had no significant change in CED. CONCLUSIONS: A single intracoronary autologous CD34+ cell infusion was safe and may potentially be an effective disease-modifying therapy for microvascular CED in humans. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03471611.


Subject(s)
Angina Pectoris/therapy , Antigens, CD34/metabolism , Coronary Artery Disease/therapy , Leukapheresis/methods , T-Lymphocytes/transplantation , Adult , Aged , Angina Pectoris/etiology , Antigens, CD34/genetics , Coronary Artery Disease/complications , Endothelium, Vascular/pathology , Female , Humans , Male , Middle Aged , T-Lymphocytes/metabolism , Transplantation, Autologous
15.
Mayo Clin Proc Innov Qual Outcomes ; 6(1): 77-85, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34926992

ABSTRACT

OBJECTIVE: To study associations between the Minnesota coronavirus disease 2019 (COVID-19) mitigation strategies on incidence rates of acute myocardial infarction (MI) or revascularization among residents of Southeast Minnesota. METHODS: Using the Rochester Epidemiology Project, all adult residents of a nine-county region of Southeast Minnesota who had an incident MI or revascularization between January 1, 2015, and December 31, 2020, were identified. Events were defined as primary in-patient diagnosis of MI or undergoing revascularization. We estimated age- and sex-standardized incidence rates and incidence rate ratios (IRRs) stratified by key factors, comparing 2020 to 2015-2019. We also calculated IRRs by periods corresponding to Minnesota's COVID-19 mitigation timeline: "Pre-lockdown" (January 1-March 11, 2020), "First lockdown" (March 12-May 31, 2020), "Between lockdowns" (June 1-November 20, 2020), and "Second lockdown" (November 21-December 31, 2020). RESULTS: The incidence rate in 2020 was 32% lower than in 2015-2019 (24 vs 36 events/100,000 person-months; IRR, 0.68; 95% CI, 0.62-0.74). Incidence rates were lower in 2020 versus 2015-2019 during the first lockdown (IRR, 0.54; 95% CI, 0.44-0.66), in between lockdowns (IRR, 0.70; 95% CI, 0.61-0.79), and during the second lockdown (IRR, 0.54; 95% CI, 0.41-0.72). April had the lowest IRR (IRR 0.48; 95% CI, 0.34-0.68), followed by August (IRR, 0.55; 95% CI, 0.40-0.76) and December (IRR, 0.56; 95% CI, 0.41-0.77). Similar declines were observed across sex and all age groups, and in both urban and rural residents. CONCLUSION: Mitigation measures for COVID-19 were associated with a reduction in hospitalizations for acute MI and revascularization in Southeast Minnesota. The reduction was most pronounced during the lockdown periods but persisted between lockdowns.

16.
Shock ; 57(3): 360-369, 2022 03 01.
Article in English | MEDLINE | ID: mdl-34864781

ABSTRACT

BACKGROUND: There are limited data on the temporal trends, incidence, and outcomes of ST-segment-elevation myocardial infarction-cardiogenic shock (STEMI-CS). METHODS: Adult (>18 years) STEMI-CS admissions were identified using the National Inpatient Sample (2000-2017) and classified by tertiles of admission year (2000-2005, 2006-2011, 2012-2017). Outcomes of interest included temporal trends, acute organ failure, cardiac procedures, in-hospital mortality, hospitalization costs, and length of stay. RESULTS: In ∼4.3 million STEMI admissions, CS was noted in 368,820 (8.5%). STEMI-CS incidence increased from 5.8% in 2000 to 13.0% in 2017 (patient and hospital characteristics adjusted odds ratio [aOR] 2.45 [95% confidence interval {CI} 2.40-2.49]; P < 0.001). Multiorgan failure increased from 55.5% (2000-2005) to 74.3% (2012-2017). Between 2000 and 2017, coronary angiography and percutaneous coronary intervention use increased from 58.8% to 80.1% and 38.6% to 70.6%, whereas coronary artery bypass grafting decreased from 14.9% to 10.4% (all P < 0.001). Over the study period, the use of intra-aortic balloon pump (40.6%-37.6%) decreased, and both percutaneous left ventricular assist devices (0%-12.9%) and extra-corporeal membrane oxygenation (0%-2.8%) increased (all P < 0.001). In hospital mortality decreased from 49.6% in 2000 to 32.7% in 2017 (aOR 0.29 [95% CI 0.28-0.31]; P < 0.001). During the 18-year period, hospital lengths of stay decreased, hospitalization costs increased and use of durable left ventricular assist device /cardiac transplantation remained stable (P > 0.05). CONCLUSIONS: In the United States, incidence of CS in STEMI has increased 2.5-fold between 2000 and 2017, while in-hospital mortality has decreased during the study period. Use of coronary angiography and PCI increased during the study period.


Subject(s)
ST Elevation Myocardial Infarction/complications , ST Elevation Myocardial Infarction/therapy , Shock, Cardiogenic/epidemiology , Shock, Cardiogenic/therapy , Aged , Aged, 80 and over , Cardiovascular Surgical Procedures , Cohort Studies , Coronary Angiography/statistics & numerical data , Databases, Factual , Female , Hospital Costs , Hospital Mortality , Hospitalization/statistics & numerical data , Humans , Incidence , Intra-Aortic Balloon Pumping/statistics & numerical data , Male , Middle Aged , Practice Patterns, Physicians'/statistics & numerical data , Procedures and Techniques Utilization , ST Elevation Myocardial Infarction/mortality , Shock, Cardiogenic/diagnosis , Time Factors , United States
17.
Mayo Clin Proc Innov Qual Outcomes ; 5(6): 1118-1127, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34877476

ABSTRACT

OBJECTIVE: To analyze outcomes of patients with ST-segment elevation myocardial infarction (STEMI) after successful primary percutaneous coronary intervention (PCI) triaged to the cardiac intensive care unit (CICU) vs a general telemetry unit by a Zwolle risk score-based algorithm. METHODS: We introduced a quality improvement protocol in 2014 encouraging admission of STEMI patients with Zwolle score of 3 or less to general telemetry units unless they were hemodynamically unstable. We subsequently conducted a retrospective single-center cohort study of consecutive STEMI patients who had undergone primary PCI from January 1, 2014, to December 31, 2018. Outcomes studied include immediate complications, need for urgent unplanned intervention, need for CICU care, length of hospitalization, and survival. RESULTS: We identified 547 patients, 406 with a Zwolle score of 3 or less. Of these, 192 (47.3%) were admitted to general telemetry and 214 (52.7%) to the CICU. Reasons for CICU admission included persistent chest pain, late presentation, and procedural complications. The average hospital length of stay was 2.1±1.4 days for non-CICU patients and 3.3±2.8 days for low-risk CICU patients (P<.001). Two patients initially admitted to general telemetry required transfer to the CICU. There were 26 patients who required unplanned cardiovascular intervention within 30 days, 5 from the general telemetry unit; 540 patients survived to discharge. One in-hospital death occurred among those initially triaged to the general telemetry unit, and this was due to a noncardiac cause. CONCLUSION: A Zwolle score-based algorithm can be used to safely triage post-PCI STEMI patients to a general telemetry unit.

18.
Mayo Clin Proc Innov Qual Outcomes ; 5(5): 839-850, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34514335

ABSTRACT

OBJECTIVE: To determine whether the Mayo Cardiac Intensive Care Unit (CICU) Admission Risk Score (M-CARS) is associated with CICU resource utilization. PATIENTS AND METHODS: Adult patients admitted to our CICU from 2007 to 2018 were retrospectively reviewed, and M-CARS was calculated from admission data. Groups were compared using Wilcoxon test for continuous variables and χ2 test for categorical variables. RESULTS: We included 12,428 patients with a mean age of 67±15 years (37% female patients). The mean M-CARS was 2.1±2.1, including 5890 (47.4%) patients with M-CARS less than 2 and 644 (5.2%) patients with M-CARS greater than 6. Critical care restricted therapies were frequently used, including mechanical ventilation in 28.0%, vasoactive medications in 25.5%, and dialysis in 4.8%. A higher M-CARS was associated with greater use of critical-care therapies and longer CICU and hospital length of stay. The low-risk cohort with M-CARS less than 2 was less likely to require critical-care-restricted therapies, including invasive or noninvasive mechanical ventilation (8.0% vs 46.1%), vasoactive medications (10.1% vs 38.8%), or dialysis (1.0% vs 8.2%), compared with patients with M-CARS greater than or equal to 2 (all P<.001). CONCLUSION: Patients with M-CARS less than 2 infrequently require critical-care resources and have extremely low mortality, suggesting that the M-CARS could be used to facilitate the triage of critically ill cardiac patients.

19.
Mayo Clin Proc ; 96(9): 2354-2365, 2021 09.
Article in English | MEDLINE | ID: mdl-34366138

ABSTRACT

OBJECTIVE: To determine whether the Mayo Cardiac Intensive Care Unit (CICU) Admission Risk Score (M-CARS) accurately predicts 1-year mortality. METHODS: We retrospectively reviewed adult CICU patients admitted from January 1, 2007, through April 30, 2018, and calculated M-CARS using admission data. We examined the association between admission M-CARS, as continuous and categorical variables, and 1-year mortality. RESULTS: This study included 12,428 unique patients with a mean age of 67.6±15.2 years (4686 [37.7%] female). A total of 2839 patients (22.8%) died within 1 year of admission, including 1149 (9.2%) hospital deaths and 1690 (15.0%) of the 11,279 hospital survivors. The 1-year survival decreased incrementally as a function of increasing M-CARS (P<.001), and all components of M-CARS were significant predictors of 1-year mortality (P<.001). The 1-year survival among hospital survivors decreased incrementally as a function of increasing M-CARS for scores below 3 (all P<.001); however, there was no further decrease in 1-year survival for hospital survivors with M-CARS of 3 or more (P=.99). The M-CARS components associated with 1-year mortality among hospital survivors included blood urea nitrogen, red blood cell distribution width, Braden skin score, and respiratory failure (all P<.001). CONCLUSION: M-CARS predicted 1-year mortality among CICU admissions, with a plateau effect at high M-CARS of 3 or more for hospital survivors. Significant added predictors of 1-year mortality among hospital survivors included markers of frailty and chronic illness.


Subject(s)
Cardiovascular Diseases/mortality , Coronary Care Units/statistics & numerical data , Risk Assessment/methods , Aged , Aged, 80 and over , Female , Hospital Mortality , Humans , Male , Middle Aged , Proportional Hazards Models , Retrospective Studies , Risk Factors , Survival Analysis
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