Publications by authors named "David R Holmes"

876 Publications

10-Year Follow-Up After Revascularization in Elderly Patients With Complex Coronary Artery Disease.

J Am Coll Cardiol 2021 06;77(22):2761-2773

Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.

Background: The optimal revascularization strategy for the elderly with complex coronary artery disease remains unclear.

Objectives: The goal of this study was to investigate 10-year all-cause mortality, life expectancy, 5-year major adverse cardiac or cerebrovascular events (MACCE), and 5-year quality of life (QOL) after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in elderly individuals (>70 years old) with 3-vessel disease (3VD) and/or left main disease (LMD).

Methods: In the present pre-specified analysis on age of the SYNTAX Extended Survival study, 10-year all-cause death and 5-year MACCE were compared with Kaplan-Meier estimates and Cox proportional hazards models among elderly or nonelderly patients. Life expectancy was estimated by restricted mean survival time within 10 years, and QOL status according to the Seattle Angina Questionnaire up to 5 years was assessed by linear mixed-effects models.

Results: Among 1,800 randomized patients, 575 patients (31.9%) were elderly. Ten-year mortality did not differ significantly between PCI and CABG in elderly (44.1% vs. 41.1%; hazard ratio [HR]: 1.08; 95% confidence interval [CI]: 0.84 to 1.40) and nonelderly patients (21.1% vs. 16.6%; HR: 1.30; 95% CI: 1.00 to 1.69; p = 0.332). Among elderly patients, 5-year MACCE was comparable between PCI and CABG (39.4% vs. 35.1%; HR: 1.18; 95% CI: 0.90 to 1.56), whereas it was significantly higher in PCI over CABG among nonelderly patients (36.3% vs. 23.0%; HR: 1.69; 95% CI: 1.36 to 2.10; p = 0.043). There were no significant difference in life expectancy (mean difference: 0.2 years in favor of CABG; 95% CI: -0.4 to 0.7) and 5-year QOL status between PCI and CABG among elderly patients.

Conclusions: Elderly patients with 3VD and/or LMD had comparable 10-year all-cause death, life expectancy, 5-year MACCE, and 5-year QOL status irrespective of revascularization mode. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050) (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972).
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http://dx.doi.org/10.1016/j.jacc.2021.04.016DOI Listing
June 2021

Impact of Body Composition Indices on Ten-year Mortality After Revascularization of Complex Coronary Artery Disease (From the Syntax Extended Survival Trial).

Am J Cardiol 2021 07 26;151:30-38. Epub 2021 May 26.

Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; NHLI, Imperial College London, London, United Kingdom. Electronic address:

Numerous studies have demonstrated a paradoxical association between higher baseline body mass index (BMI) and lower long-term mortality risk after coronary revascularization, known as the "obesity paradox", possibly relying on the single use of BMI. The current study is a post-hoc analysis of the SYNTAX Extended Survival (SYNTAXES) trial, which is the extended follow-up of the SYNTAX trial comparing percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) in patients with left-main coronary artery disease (LMCAD) or three-vessel disease (3VD). Patients were stratified according to baseline BMI and/or waist circumference (WC). Out of 1,800 patients, 1,799 (99.9%) and 1,587 (88.2%) had available baseline BMI and WC data, respectively. Of those, 1,327 (73.8%) patients had High BMI (≥25 kg/m), whereas 705 (44.4%) patients had High WC (>102 cm for men or >88 cm for women). When stratified by both BMI and WC, 10-year mortality risk was significantly higher in patients with Low BMI/Low WC (adjusted hazard ratio [HR]: 1.65; 95% confidence interval [CI]: 1.09 to 2.51), Low BMI/ High WC (adjusted HR: 2.74; 95% CI: 1.12 to 6.69), or High BMI/High WC (adjusted HR: 1.59; 95% CI: 1.11 to 2.27) compared to those with High BMI/Low WC. In conclusion, the "obesity paradox" following coronary revascularization would be driven by low long-term mortality risk of the High BMI/Low WC group. Body composition should be assessed by the combination of BMI and WC in the appropriate evaluation of the long-term risk of obesity in patients with LMCAD or 3VD.
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http://dx.doi.org/10.1016/j.amjcard.2021.04.008DOI Listing
July 2021

Influence of intra-aortic balloon pump on mortality as a function of cardiogenic shock severity.

Catheter Cardiovasc Interv 2021 May 28. Epub 2021 May 28.

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.

Background: Randomized studies of intra-aortic balloon pump (IABP) in cardiogenic shock (CS) have only included on patients with acute coronary syndromes (ACS) without stratification according to shock severity. We examined the association between IABP and mortality in CS patients across the Society for Cardiovascular Angiography and Intervention (SCAI) shock stages.

Methods: We included cardiac intensive care unit patients admitted from 2007 to 2015 with CS from any etiology. In-hospital mortality associated with IABP was examined in each SCAI shock stage. Multivariable logistic regression was performed using inverse probability of treatment weighting (IPTW) to determine the association between IABP and in-hospital mortality.

Results: We included 934 patients, with a mean age of 68 ± 14 years; 60% had ACS. The distribution of SCAI shock stages was: B, 41%; C, 13%; D, 38%; E, 8%. In-hospital mortality was lower in the 39% of patients who received IABP (27% vs. 43%, adjusted OR with IABP after IPTW 0.53, 95% CI 0.40-0.72, p < .0001). IABP use was associated with lower crude in-hospital mortality in each SCAI shock stage (all p < .05, except p = .08 in SCAI shock stage E). We did not observe any significant heterogeneity in the association between IABP use and in-hospital mortality as a function of SCAI shock stage.

Conclusions: Patients with CS who were selected to receive an IABP had lower in-hospital mortality, without differences in this effect across the SCAI shock stages. Future studies should account for the severity and etiology of shock when evaluating the efficacy of IABP for CS.
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http://dx.doi.org/10.1002/ccd.29800DOI Listing
May 2021

Racial and Ethnic Disparities in Management and Outcomes of Cardiac Arrest Complicating Acute Myocardial Infarction.

J Am Heart Assoc 2021 06 20;10(11):e019907. Epub 2021 May 20.

Department of Cardiovascular Medicine Mayo Clinic Rochester MN.

Background The role of race and ethnicity in the outcomes of cardiac arrest (CA) complicating acute myocardial infarction (AMI) is incompletely understood. Methods and Results This was a retrospective cohort study of adult admissions with AMI-CA from the National Inpatient Sample (2012-2017). Self-reported race/ethnicity was classified as White, Black, and others (Hispanic, Asian or Pacific Islander, Native American, Other). Outcomes of interest included in-hospital mortality, coronary angiography, percutaneous coronary intervention, palliative care consultation, do-not-resuscitate status use, hospitalization costs, hospital length of stay, and discharge disposition. Of the 3.5 million admissions with AMI, CA was noted in 182 750 (5.2%), with White, Black, and other races/ethnicities constituting 74.8%, 10.7%, and 14.5%, respectively. Black patients admitted with AMI-CA were more likely to be female, with more comorbidities, higher rates of non-ST-segment-elevation myocardial infarction, and higher neurological and renal failure. Admissions of patients of Black and other races/ethnicities underwent coronary angiography (61.9% versus 70.2% versus 73.1%) and percutaneous coronary intervention (44.6% versus 53.0% versus 58.1%) less frequently compared to patients of white race (<0.001). Admissions of patients with AMI-CA had significantly higher unadjusted mortality (47.4% and 47.4%) as compared with White patients admitted (40.9%). In adjusted analyses, Black race was associated with lower in-hospital mortality (odds ratio [OR], 0.95; 95% CI, 0.91-0.99; =0.007) whereas other races had higher in-hospital mortality (OR, 1.11; 95% CI, 1.08-1.15; <0.001) compared with White race. Admissions of Black patients with AMI-CA had longer length of hospital stay, higher rates of palliative care consultation, less frequent do-not-resuscitate status use, and fewer discharges to home (all <0.001). Conclusions Racial and ethnic minorities received less frequent guideline-directed procedures and had higher in-hospital mortality and worse outcomes in AMI-CA.
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http://dx.doi.org/10.1161/JAHA.120.019907DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8483555PMC
June 2021

Ten-Year All-Cause Death According to Completeness of Revascularization in Patients With Three-Vessel Disease or Left Main Coronary Artery Disease: Insights From the SYNTAX Extended Survival Study.

Circulation 2021 07 20;144(2):96-109. Epub 2021 May 20.

Department of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, MN (D.R.H.).

Background: Ten-year all-cause death according to incomplete (IR) versus complete revascularization (CR) has not been fully investigated in patients with 3-vessel disease and left main coronary artery disease undergoing percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG).

Methods: The SYNTAX Extended Survival study (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]) evaluated vital status up to 10 years in patients who were originally enrolled in the SYNTAX trial. In the present substudy, outcomes of the CABG CR group were compared with the CABG IR, PCI CR, and PCI IR groups. In addition, in the PCI cohort, the residual SYNTAX score (rSS) was used to quantify the extent of IR and to assess its association with fatal late outcome. The rSS of 0 suggests CR, whereas a rSS>0 identifies the degree of IR.

Results: IR was more frequently observed in patients with PCI versus CABG (56.6% versus 36.8%) and more common in those with 3-vessel disease than left main coronary artery disease in both the PCI arm (58.5% versus 53.8%) and the CABG arm (42.8% versus 27.5%). Patients undergoing PCI with CR had no significant difference in 10-year all-cause death compared with those undergoing CABG (22.2% for PCI with CR versus 24.3% for CABG with IR versus 23.8% for CABG with CR). In contrast, those with PCI and IR had a significantly higher risk of all-cause death at 10 years compared with CABG and CR (33.5% versus 23.7%; adjusted hazard ratio, 1.48 [95% CI, 1.15-1.91]). When patients with PCI were stratified according to the rSS, those with a rSS≤8 had no significant difference in all-cause death at 10 years as the other terciles (22.2% for rSS=0 versus 23.9% for rSS>0-4 versus 28.9% for rSS>4-8), whereas a rSS>8 had a significantly higher risk of 10-year all-cause death than those undergoing PCI with CR (50.1% versus 22.2%; adjusted hazard ratio, 3.40 [95% CI, 2.13-5.43]).

Conclusions: IR is common after PCI, and the degree of incompleteness was associated with 10-year mortality. If it is unlikely that complete (or nearly complete; rSS<8) revascularization can be achieved with PCI in patients with 3-vessel disease, CABG should be considered. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00114972. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03417050.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.046289DOI Listing
July 2021

Temporal Trends, Clinical Characteristics, and Outcomes of Emergent Coronary Artery Bypass Grafting for Acute Myocardial Infarction in the United States.

J Am Heart Assoc 2021 08 15;10(15):e020517. Epub 2021 May 15.

Section of Interventional Cardiology Division of Cardiovascular Medicine Department of Medicine Emory University School of Medicine Atlanta GA.

Background There are limited contemporary data on the use of emergent coronary artery bypass grafting (CABG) in acute myocardial infarction. Methods and Results Adult (aged >18 years) acute myocardial infarction admissions were identified using the National (Nationwide) Inpatient Sample (2000-2017) and classified by tertiles of admission year. Outcomes of interest included temporal trends of CABG use; age-, sex-, and race-stratified trends in CABG use; in-hospital mortality; hospitalization costs; and hospital length of stay. Of the 11 622 528 acute myocardial infarction admissions, emergent CABG was performed in 1 071 156 (9.2%). CABG utilization decreased overall (10.5% [2000] to 8.7% [2017]; adjusted odds ratio [OR], 0.98 [95% CI, 0.98-0.98]; <0.001), in ST-segment-elevation myocardial infarction (10.2% [2000] to 5.2% [2017]; adjusted OR, 0.95 [95% CI, 0.95-0.95]; <0.001) and non-ST-segment-elevation myocardial infarction (10.8% [2000] to 10.0% [2017]; adjusted OR, 0.99 [95% CI, 0.99-0.99]; <0.001), with consistent age, sex, and race trends. In 2012 to 2017, compared with 2000 to 2005, admissions receiving emergent CABG were more likely to have non-ST-segment-elevation myocardial infarction (80.5% versus 56.1%), higher rates of noncardiac multiorgan failure (26.1% versus 8.4%), cardiogenic shock (11.5% versus 6.4%), and use of mechanical circulatory support (19.8% versus 18.7%). In-hospital mortality in CABG admissions decreased from 5.3% (2000) to 3.6% (2017) (adjusted OR, 0.89; 95% CI, 0.88-0.89 [<0.001]) in the overall cohort, with similar temporal trends in patients with ST-segment-elevation myocardial infarction and non-ST-segment-elevation myocardial infarction. An increase in lengths of hospital stay and hospitalization costs was seen over time. Conclusions Utilization of CABG has decreased substantially in acute myocardial infarction admissions, especially in patients with ST-segment-elevation myocardial infarction. Despite an increase in acuity and multiorgan failure, in-hospital mortality consistently decreased in this population.
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http://dx.doi.org/10.1161/JAHA.120.020517DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8475667PMC
August 2021

Impact of stent length and diameter on 10-year mortality in the SYNTAXES trial.

Catheter Cardiovasc Interv 2021 09 5;98(3):E379-E387. Epub 2021 May 5.

Department of Cardiology, National University of Ireland, Galway (NUIG), Galway.

Objectives: We investigated the impact of total stent length (TSL) and average nominal stent diameter (ASD) on 10-year mortality after percutaneous coronary intervention (PCI) in the SYNTAXES trial.

Background: TSL and ASD in patients treated with PCI are associated with major adverse cardiovascular events. However, the treatment effect of PCI with extensive and/or small stenting as compared with coronary artery bypass grafting (CABG) for complex coronary artery disease has not been fully evaluated.

Methods: Impacts on mortality of extensive stenting defined as TSL >100 mm and small stenting as ASD <3 mm were analyzed in 893 PCI patients and were compared to 865 CABG patients.

Results: TSL as a continuous variable was significantly associated with 10-year mortality (adjusted hazard ratio [HR], 1.05 [1.01-1.09] per 10 mm increase). PCI patients with extensive stenting had a higher 10 year mortality than CABG patients (adjusted HR, 1.97 [1.41-2.74]) or not- extensive stenting PCI (adjusted HR, 1.94 [1.36-2.77]). Although ASD did not have a significant association with 10 year mortality (adjusted HR, 0.97 [0.85-1.11] per 0.25 mm increase), PCI with small stents was associated with a higher 10 year mortality, compared to CABG (adjusted HR, 1.66 [1.23-2.26]) and PCI performed with large stents (adjusted HR, 1.74 [1.19-2.53]). Patients treated with not-extensive and large stents had similar mortality rates (24.0 versus 23.8%) as those treated with CABG.

Conclusions: Extensive and small stenting were associated with higher 10 year mortality, compared with CABG. When patients have to be treated with extensive or small stenting, revascularization with CABG should be preferred.
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http://dx.doi.org/10.1002/ccd.29721DOI Listing
September 2021

Racial Disparities in the Utilization and Outcomes of Temporary Mechanical Circulatory Support for Acute Myocardial Infarction-Cardiogenic Shock.

J Clin Med 2021 Apr 2;10(7). Epub 2021 Apr 2.

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN 55905, USA.

Racial disparities in utilization and outcomes of mechanical circulatory support (MCS) in patients with acute myocardial infarction-cardiogenic shock (AMI-CS) are infrequently studied. This study sought to evaluate racial disparities in the outcomes of MCS in AMI-CS. The National Inpatient Sample (2012-2017) was used to identify adult AMI-CS admissions receiving MCS support. MCS devices were classified as intra-aortic balloon pump (IABP), percutaneous left ventricular assist device (pLVAD) or extracorporeal membrane oxygenation (ECMO). Self-reported race was classified as white, black and others. Outcomes included in-hospital mortality, hospital length of stay and discharge disposition. During this period, 90,071 admissions were included with white, black and other races constituting 73.6%, 8.3% and 18.1%, respectively. Compared to white and other races, black race admissions were on average younger, female, with greater comorbidities, and non-cardiac organ failure (all < 0.001). Compared to the white race (31.3%), in-hospital mortality was comparable in black (31.4%; adjusted odds ratio (aOR) 0.98 (95% confidence interval (CI) 0.93-1.05); = 0.60) and other (30.2%; aOR 0.96 (95% CI 0.92-1.01); = 0.10). Higher in-hospital mortality was noted in non-white races with concomitant cardiac arrest, and those receiving ECMO support. Black admissions had longer lengths of hospital stay (12.1 ± 14.2, 10.3 ± 11.2, 10.9 ± 1.2 days) and transferred less often (12.6%, 14.2%, 13.9%) compared to white and other races (both < 0.001). In conclusion, this study of AMI-CS admissions receiving MCS devices did not identify racial disparities in in-hospital mortality. Black admissions had longer hospital stay and were transferred less often. Further evaluation with granular data including angiographic and hemodynamic parameters is essential to rule out racial differences.
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http://dx.doi.org/10.3390/jcm10071459DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8037539PMC
April 2021

Variation in Antithrombotic Therapy and Clinical Outcomes in Patients With Preexisting Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

Circ Cardiovasc Interv 2021 04 20;14(4):e009963. Epub 2021 Apr 20.

Duke Clinical Research Institute, Durham, NC (M.W.S., S.V., Z.L., J.P., J.K.H., A.N.V., E.D.P.).

Background: Optimal antithrombotic management of patients with preexisting atrial fibrillation undergoing transcatheter aortic valve replacement is challenging given the need to balance the risk of bleeding and thromboembolism. We aimed to examine variation in care and association of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality in patients undergoing transcatheter aortic valve replacement with concomitant atrial fibrillation in the United States.

Methods: Patients who underwent transcatheter aortic valve replacement with preexisting atrial fibrillation from November 2011 through September 2015 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry linked to the Medicare database were examined according to receipt of oral anticoagulants (OACs) or antiplatelet therapies (APTs) or a combination of these (OAC+APT) at discharge. To assess the associations of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality, we utilized inverse probability weighting for antithrombotic therapies and multivariable regression modeling to adjust for patient- and hospital-level variables.

Results: In the 11 382 patients included in our study, 5833 (51.2%) were discharged on OAC+APT, 4786 (42.0%) on APT alone, and 763 (6.7%) on OAC alone. There was significant variability in discharge medication patterns, including 42% of patients discharged without OAC therapy. In adjusted analyses, the risk for all-cause mortality and stroke was not significantly different when comparing the 3 different antithrombotic strategies. Risk of bleeding was higher with OAC+APT compared with APT alone (hazard ratio, 1.16 [95% CI, 1.05–1.27]) and similar compared with OAC alone (hazard ratio, 1.17 [95% CI, 0.93–1.47]).

Conclusions: There was significant variability in discharge medication patterns across US sites in patients with atrial fibrillation undergoing transcatheter aortic valve replacement, including significant underuse of OAC in this high-risk cohort. The use of OAC+APT (versus OAC alone or APT alone) was not associated with a lower risk of stroke or mortality but was associated with increased risk of bleeding complications at 1 year compared with APT alone.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009963DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8300574PMC
April 2021

Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial.

Circulation 2021 05 6;143(18):1754-1762. Epub 2021 Apr 6.

Boston Scientific Corporation, Marlborough, MA (R.D.S., N.T.G., D.J.A.).

Background: Left atrial appendage (LAA) occlusion provides an alternative to oral anticoagulation for thromboembolic risk reduction in patients with nonvalvular atrial fibrillation. Since regulatory approval in 2015, the WATCHMAN device has been the only LAA closure device available for clinical use in the United States. The PINNACLE FLX study (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) evaluated the safety and effectiveness of the next-generation WATCHMAN FLX LAA closure device in patients with nonvalvular atrial fibrillation in whom oral anticoagulation is indicated, but who have an appropriate rationale to seek a nonpharmaceutical alternative.

Methods: This was a prospective, nonrandomized, multicenter US Food and Drug Administration study. The primary safety end point was the occurrence of one of the following events within 7 days after the procedure or by hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring cardiac surgery. The primary effectiveness end point was the incidence of effective LAA closure (peri-device flow ≤5 mm), as assessed by the echocardiography core laboratory at 12-month follow-up.

Results: A total of 400 patients were enrolled. The mean age was 73.8±8.6 years and the mean CHADS-VASc score was 4.2±1.5. The incidence of the primary safety end point was 0.5% with a 1-sided 95% upper CI of 1.6%, meeting the performance goal of 4.2% (<0.0001). The incidence of the primary effectiveness end point was 100%, with a 1-sided 95% lower CI of 99.1%, again meeting the performance goal of 97.0% (<0.0001). Device-related thrombus was reported in 7 patients, no patients experienced pericardial effusion requiring open cardiac surgery, and there were no device embolizations.

Conclusions: LAA closure with this next-generation LAA closure device was associated with a low incidence of adverse events and a high incidence of anatomic closure. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02702271.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.050117DOI Listing
May 2021

Racial, ethnic and socioeconomic disparities in patients undergoing left atrial appendage closure.

Heart 2021 12 1;107(24):1946-1955. Epub 2021 Apr 1.

Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada

Objective: This manuscript aims to explore the impact of race/ethnicity and socioeconomic status on in-hospital complication rates after left atrial appendage closure (LAAC).

Methods: The US National Inpatient Sample was used to identify hospitalisations for LAAC between 1 October 2015 to 31 December 2018. These patients were stratified by race/ethnicity and quartiles of median neighbourhood income. The primary outcome was the occurrence of in-hospital major adverse events, defined as a composite of postprocedural bleeding, cardiac and vascular complications, acute kidney injury and ischaemic stroke.

Results: Of 6478 unweighted hospitalisations for LAAC, 58% were male and patients of black, Hispanic and 'other' race/ethnicity each comprised approximately 5% of the cohort. Adjusted by the older Americans population, the estimated number of LAAC procedures was 69.2/100 000 for white individuals, as compared with 29.5/100 000 for blacks, 47.2/100 000 for Hispanics and 40.7/100 000 for individuals of 'other' race/ethnicity. Black patients were ~5 years younger but had a higher comorbidity burden. The primary outcome occurred in 5% of patients and differed significantly between racial/ethnic groups (p<0.001) but not across neighbourhood income quartiles (p=0.88). After multilevel modelling, the overall rate of in-hospital major adverse events was higher in black patients as compared with whites (OR: 1.60, 95% CI 1.22 to 2.10, p<0.001); however, the incidence of acute kidney injury was higher in Hispanics (OR: 2.19, 95% CI 1.52 to 3.17, p<0.001). No significant differences were found in adjusted overall in-hospital complication rates between income quartiles.

Conclusion: In this study assessing racial/ethnic disparities in patients undergoing LAAC, minorities are under-represented, specifically patients of black race/ethnicity. Compared with whites, black patients had higher comorbidity burden and higher rates of in-hospital complications. Lower socioeconomic status was not associated with complication rates.
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http://dx.doi.org/10.1136/heartjnl-2020-318650DOI Listing
December 2021

Hemodynamic Basis for Dyspnea in Pulmonary Vein Stenosis.

Circ Heart Fail 2021 04 25;14(4):e007820. Epub 2021 Mar 25.

Department of Cardiovascular Medicine, Mayo Clinic, MN.

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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.120.007820DOI Listing
April 2021

Impact of chronic obstructive pulmonary disease on 10-year mortality after percutaneous coronary intervention and bypass surgery for complex coronary artery disease: insights from the SYNTAX Extended Survival study.

Clin Res Cardiol 2021 Jul 12;110(7):1083-1095. Epub 2021 Mar 12.

Department of Cardiology, National University of Ireland, Galway (NUIG), P.O. University Road, Galway, H91 TK33, Ireland.

Aims: To evaluate the impact of chronic obstructive pulmonary disease (COPD) on 10-year all-cause death and the treatment effect of CABG versus PCI on 10-year all-cause death in patients with three-vessel disease (3VD) and/or left main coronary artery disease (LMCAD) and COPD.

Methods: Patients were stratified according to COPD status and compared with regard to clinical outcomes. Ten-year all-cause death was examined according to the presence of COPD and the revascularization strategy.

Results: COPD status was available for all randomized 1800 patients, of whom, 154 had COPD (8.6%) at the time of randomization. Regardless of the revascularization strategy, patients with COPD had a higher risk of 10-year all-cause death, compared with those without COPD (43.1% vs. 24.9%; hazard ratio [HR]: 2.03; 95% confidence interval [CI]: 1.56-2.64; p < 0.001). Among patients with COPD, CABG appeared to have a slightly lower risk of 10-year all-cause death compared with PCI (42.3% vs. 43.9%; HR: 0.96; 95% CI: 0.59-1.56, p = 0.858), whereas among those without COPD, CABG had a significantly lower risk of 10-year all-cause death (22.7% vs. 27.1%; HR: 0.81; 95% CI: 0.67-0.99, p = 0.041). There was no significant differential treatment effect of CABG versus PCI on 10-year all-cause death between patients with and without COPD (p  = 0.544).

Conclusions: COPD was associated with a higher risk of 10-year all-cause death after revascularization for complex coronary artery disease. The presence of COPD did not significantly modify the beneficial effect of CABG versus PCI on 10-year all-cause death.

Trial Registration: SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.
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http://dx.doi.org/10.1007/s00392-021-01833-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8238698PMC
July 2021

Fibrinolysis vs. primary percutaneous coronary intervention for ST-segment elevation myocardial infarction cardiogenic shock.

ESC Heart Fail 2021 06 11;8(3):2025-2035. Epub 2021 Mar 11.

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.

Aims: There are limited contemporary data on the use of initial fibrinolysis in ST-segment elevation myocardial infarction cardiogenic shock (STEMI-CS). This study sought to compare the outcomes of STEMI-CS receiving initial fibrinolysis vs. primary percutaneous coronary intervention (PPCI).

Methods: Using the National (Nationwide) Inpatient Sample from 2009 to 2017, a comparative effectiveness study of adult (>18 years) STEMI-CS admissions receiving pre-hospital/in-hospital fibrinolysis were compared with those receiving PPCI. Admissions with alternate indications for fibrinolysis and STEMI-CS managed medically or with surgical revascularization (without fibrinolysis) were excluded. Outcomes of interest included in-hospital mortality, development of non-cardiac organ failure, complications, hospital length of stay, hospitalization costs, use of palliative care, and do-not-resuscitate status.

Results: During 2009-2017, 5297 and 110 452 admissions received initial fibrinolysis and PPCI, respectively. Compared with those receiving PPCI, the fibrinolysis group was more often non-White, with lower co-morbidity, and admitted on weekends and to small rural hospitals (all P < 0.001). In the fibrinolysis group, 95.3%, 77.4%, and 15.7% received angiography, PCI, and coronary artery bypass grafting, respectively. The fibrinolysis group had higher rates of haemorrhagic complications (13.5% vs. 9.9%; P < 0.001). The fibrinolysis group had comparable all-cause in-hospital mortality [logistic regression analysis: 28.8% vs. 28.5%; propensity-matched analysis: 30.8% vs. 30.3%; adjusted odds ratio 0.97 (95% confidence interval 0.90-1.05); P = 0.50]. The fibrinolysis group had comparable rates of acute organ failure, hospital length of stay, rates of palliative care referrals, do-not-resuscitate status use, and lesser hospitalization costs.

Conclusions: The use of initial fibrinolysis had comparable in-hospital mortality than those receiving PPCI in STEMI-CS in the contemporary era in this large national observational study.
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http://dx.doi.org/10.1002/ehf2.13281DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8120407PMC
June 2021

Ten-year all-cause mortality according to smoking status in patients with severe coronary artery disease undergoing surgical or percutaneous revascularization.

Eur J Prev Cardiol 2020 Nov 30. Epub 2020 Nov 30.

Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.

Aims: To evaluate the impact of various smoking status on 10-year all-cause mortality and to examine a relative treatment benefit of coronary artery bypass grafting (CABG) vs. percutaneous coronary intervention (PCI) according to smoking habits.

Methods And Results: The SYNTAX Extended Survival study evaluated vital status up to 10 years in 1800 patients with de novo three-vessel disease and/or left main coronary artery disease randomized to CABG or PCI in the SYNTAX trial. In the present analysis, patients were divided into three groups (current, former, or never smokers), and the primary endpoint of 10-year all-cause mortality was assessed according to smoking status. Smoking status was available in 1793 (99.6%) patients at the time of randomization, of whom 363 were current smokers, 798 were former smokers, and 632 were never smokers. The crude rates of 10-year all-cause mortality were 29.7% in current smokers, 25.3% in former smokers, and 25.9% in never smokers (Log-rank P = 0.343). After adjustment for imbalances in baseline characteristics, current smokers had a significantly higher risk of 10-year all-cause mortality than never smokers [adjusted hazard ratio (aHR): 2.29; 95% confidence interval (CI): 1.60-3.27; P < 0.001], whereas former smokers did not. PCI was associated with a higher risk of all-cause mortality than CABG among current smokers (HR: 1.60; 95% CI: 1.09-2.35; P = 0.017), but it failed to show a significant interaction between revascularization strategies and smoking status (Pinteraction = 0.910).

Conclusion: Current smokers had a higher adjusted risk of 10-year all-cause mortality, whereas former smokers did not. The treatment effect of CABG vs. PCI did not differ significantly according to smoking status.

Clinical Trial Registration: SYNTAX: ClinicalTrials.gov reference: NCT00114972; SYNTAX Extended Survival. ClinicalTrials.gov reference: NCT03417050.
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http://dx.doi.org/10.1093/eurjpc/zwaa089DOI Listing
November 2020

Influence of age and shock severity on short-term survival in patients with cardiogenic shock.

Eur Heart J Acute Cardiovasc Care 2021 Aug;10(6):604-612

Department of Interventional and General Cardiology, University Heart Centre Hamburg, Hamburg, Germany.

Aims: Cardiogenic shock (CS) is associated with poor outcomes in older patients, but it remains unclear if this is due to higher shock severity. We sought to determine the associations between age and shock severity on mortality among patients with CS.

Methods And Results: Patients with a diagnosis of CS from Mayo Clinic (2007-15) and University Clinic Hamburg (2009-17) were subdivided by age. Shock severity was graded using the Society for Cardiovascular Angiography and Intervention (SCAI) shock stages. Predictors of 30-day survival were determined using Cox proportional-hazards analysis. We included 1749 patients (934 from Mayo Clinic and 815 from University Clinic Hamburg), with a mean age of 67.6 ± 14.6 years, including 33.6% females. Acute coronary syndrome was the cause of CS in 54.0%. The distribution of SCAI shock stages was 24.1%; C, 28.0%; D, 33.2%; and E, 14.8%. Older patients had similar overall shock severity, more co-morbidities, worse kidney function, and decreased use of mechanical circulatory support compared to younger patients. Overall 30-day survival was 53.3% and progressively decreased as age or SCAI shock stage increased, with a clear gradient towards lower 30-day survival as a function of increasing age and SCAI shock stage. Progressively older age groups had incrementally lower adjusted 30-day survival than patients aged <50 years.

Conclusion: Older patients with CS have lower short-term survival, despite similar shock severity, with a high risk of death in older patients with more severe shock. Further research is needed to determine the optimal treatment strategies for older CS patients.
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http://dx.doi.org/10.1093/ehjacc/zuaa035DOI Listing
August 2021

Antithrombotic Therapy in Patients With Atrial Fibrillation Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention: A North American Perspective: 2021 Update.

Circulation 2021 02 8;143(6):583-596. Epub 2021 Feb 8.

Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (D.L.B., C.P.C., D.P.F.).

A growing number of patients undergoing percutaneous coronary intervention (PCI) with stent implantation also have atrial fibrillation. This poses challenges for their optimal antithrombotic management because patients with atrial fibrillation undergoing PCI require oral anticoagulation for the prevention of cardiac thromboembolism and dual antiplatelet therapy for the prevention of coronary thrombotic complications. The combination of oral anticoagulation and dual antiplatelet therapy substantially increases the risk of bleeding. Over the last decade, a series of North American Consensus Statements on the Management of Antithrombotic Therapy in Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention have been reported. Since the last update in 2018, several pivotal clinical trials in the field have been published. This document provides a focused updated of the 2018 recommendations. The group recommends that in patients with atrial fibrillation undergoing PCI, a non-vitamin K antagonist oral anticoagulant is the oral anticoagulation of choice. Dual antiplatelet therapy with aspirin and a P2Y inhibitor should be given to all patients during the peri-PCI period (during inpatient stay, until time of discharge, up to 1 week after PCI, at the discretion of the treating physician), after which the default strategy is to stop aspirin and continue treatment with a P2Y inhibitor, preferably clopidogrel, in combination with a non-vitamin K antagonist oral anticoagulant (ie, double therapy). In patients at increased thrombotic risk who have an acceptable risk of bleeding, it is reasonable to continue aspirin (ie, triple therapy) for up to 1 month. Double therapy should be given for 6 to 12 months with the actual duration depending on the ischemic and bleeding risk profile of the patient, after which patients should discontinue antiplatelet therapy and receive oral anticoagulation alone.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.050438DOI Listing
February 2021

Mortality 10 Years After Percutaneous or Surgical Revascularization in Patients With Total Coronary Artery Occlusions.

J Am Coll Cardiol 2021 02;77(5):529-540

Department of Cardiology, National University of Ireland, Galway, Galway, Ireland.

Background: The long-term clinical benefit after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with total occlusions (TOs) and complex coronary artery disease has not yet been clarified.

Objectives: The objective of this analysis was to assess 10-year all-cause mortality in patients with TOs undergoing PCI or CABG.

Methods: This is a subanalysis of patients with at least 1 TO in the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study, which investigated 10-year all-cause mortality in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial, beyond its original 5-year follow-up. Patients with TOs were further stratified according to the status of TO recanalization or revascularization.

Results: Of 1,800 randomized patients to the PCI or CABG arm, 460 patients had at least 1 lesion of TO. In patients with TOs, the status of TO recanalization or revascularization was not associated with 10-year all-cause mortality, irrespective of the assigned treatment (PCI arm: 29.9% vs. 29.4%; adjusted hazard ratio [HR]: 0.992; 95% confidence interval [CI]: 0.474 to 2.075; p = 0.982; and CABG arm: 28.0% vs. 21.4%; adjusted HR: 0.656; 95% CI: 0.281 to 1.533; p = 0.330). When TOs existed in left main and/or left anterior descending artery, the status of TO recanalization or revascularization did not have an impact on the mortality (34.5% vs. 26.9%; adjusted HR: 0.896; 95% CI: 0.314 to 2.555; p = 0.837).

Conclusions: At 10-year follow-up, the status of TO recanalization or revascularization did not affect mortality, irrespective of the assigned treatment and location of TOs. The present study might support contemporary practice among high-volume chronic TO-PCI centers where recanalization is primarily offered to patients for the management of angina refractory to medical therapy when myocardial viability is confirmed. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972).
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http://dx.doi.org/10.1016/j.jacc.2020.11.055DOI Listing
February 2021

Ten-year all-cause death following percutaneous or surgical revascularization in patients with prior cerebrovascular disease: insights from the SYNTAX Extended Survival study.

Clin Res Cardiol 2021 Oct 30;110(10):1543-1553. Epub 2021 Jan 30.

Department of Cardiology, National University of Ireland Galway, University Road, Galway, H91 TK33, Ireland.

Background: Coronary bypass artery grafting (CABG) has a higher procedural risk of stroke than percutaneous coronary intervention (PCI), but may offer better long-term survival. The optimal revascularization strategy for patients with prior cerebrovascular disease (CEVD) remains unclear.

Methods And Results: The SYNTAXES study assessed the vital status out to 10 year of patients with three-vessel disease and/or left main coronary artery disease enrolled in the SYNTAX trial. The relative efficacy of PCI vs. CABG in terms of 10 year all-cause death was assessed according to prior CEVD. The primary endpoint was 10 year all-cause death. The status of prior CEVD was available in 1791 (99.5%) patients, of whom 253 patients had prior CEVD. Patients with prior CEVD were older and had more comorbidities (medically treated diabetes, insulin-dependent diabetes, metabolic syndrome, peripheral vascular disease, chronic obstructive pulmonary disease, impaired renal function, and congestive heart failure), compared with those without prior CEVD. Prior CEVD was an independent predictor of 10 year all-cause death (adjusted HR: 1.35; 95% CI: 1.04-1.73; p = 0.021). Patients with prior CEVD had a significantly higher risk of 10 year all-cause death (41.1 vs. 24.1%; HR: 1.92; 95% CI: 1.54-2.40; p < 0.001). The risk of 10 year all-cause death was similar between patients receiving PCI or CABG irrespective of the presence of prior CEVD (p = 0.624).

Conclusion: Prior CEVD was associated with a significantly increased risk of 10 year all-cause death which was similar in patients treated with PCI or CABG. These results do not support preferential referral for PCI rather than CABG in patients with prior CEVD.

Trial Registration: SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.
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http://dx.doi.org/10.1007/s00392-020-01802-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8484131PMC
October 2021

Defining Shock and Preshock for Mortality Risk Stratification in Cardiac Intensive Care Unit Patients.

Circ Heart Fail 2021 01 19;14(1):e007678. Epub 2021 Jan 19.

Sentara Heart Hospital, Advanced Heart Failure Center and Eastern Virginia Medical School, Norfolk, Virginia (D.A.B.).

Background: Previous studies have defined preshock as isolated hypotension or isolated hypoperfusion, whereas shock has been variably defined as hypoperfusion with or without hypotension. We aimed to evaluate the mortality risk associated with hypotension and hypoperfusion at the time of admission in a cardiac intensive care unit population.

Methods: We analyzed Mayo Clinic cardiac intensive care unit patients admitted between 2007 and 2015. Hypotension was defined as systolic blood pressure <90 mm Hg or mean arterial pressure <60 mm Hg, and hypoperfusion as admission lactate >2 mmol/L, oliguria, or rising creatinine. Associations between hypotension and hypoperfusion with hospital mortality were estimated using multivariable logistic regression.

Results: Among 10 004 patients with a median age of 69 years, 43.1% had acute coronary syndrome, and 46.1% had heart failure. Isolated hypotension was present in 16.7%, isolated hypoperfusion in 15.3%, and 8.7% had both hypotension and hypoperfusion. Stepwise increases in hospital mortality were observed with hypotension and hypoperfusion compared with neither hypotension nor hypoperfusion (3.3%; all <0.001): isolated hypotension, 9.3% (adjusted odds ratio, 1.7 [95% CI, 1.4-2.2]); isolated hypoperfusion, 17.2% (adjusted odds ratio, 2.3 [95% CI, 1.9-3.0]); both hypotension and hypoperfusion, 33.8% (adjusted odds ratio, 2.8 [95% CI, 2.1-3.6]). Adjusted hospital mortality in patients with isolated hypoperfusion was higher than in patients with isolated hypotension (=0.02) and not significant different from patients with both hypotension and hypoperfusion (=0.18).

Conclusions: Hypotension and hypoperfusion are both associated with increased mortality in cardiac intensive care unit patients. Hospital mortality is higher with isolated hypoperfusion or concomitant hypotension and hypoperfusion (classic shock). We contend that preshock should refer to isolated hypotension without hypoperfusion, while patients with hypoperfusion can be considered to have shock, irrespective of blood pressure.
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.120.007678DOI Listing
January 2021

Long-Term Clinical Outcomes of Underdosed Direct Oral Anticoagulants in Patients with Atrial Fibrillation and Atrial Flutter.

Am J Med 2021 06 12;134(6):788-796. Epub 2021 Jan 12.

Department of Cardiovascular Diseases, Mayo Clinic, Phoenix Ariz.

Background: Although direct oral anticoagulants (DOACs) have been shown to be effective at reducing the risk of stroke in patients with atrial fibrillation/flutter (AF), they are sometimes underdosed off-label to mitigate their associated higher bleeding risk. We sought to evaluate frequency and clinical outcomes of inappropriate underdosing of DOACS in patients with AF.

Methods: We conducted a study of subjects with AF who had a clinical indication for stroke prophylaxis (with a congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65 to 47 years, sex category [CHADS-VASc] of 2 or greater) and were prescribed 1 of the 4 clinically approved DOACs (apixaban, rivaroxaban, dabigatran, or edoxaban). We compared all-cause mortality, composite of stroke and systemic embolism, composite of myocardial infarction (MI), acute coronary syndromes (ACS), and coronary revascularization, and major bleeding between patients appropriately dosed and inappropriately underdosed.

Results: A total of 8125 patients met inclusion criteria, with a mean follow up of 2.2 ± 2 years. Of those, 1724 patients (21.2%) were inappropriately dosed. After adjusting for baseline variables, there was no difference in all-cause mortality, risk of stroke or systemic embolism, International Society on Thrombosis and Haemostasis (ISTH) major bleeding, or composite of myocardial infarction, acute coronary syndromes, or coronary revascularization between patients appropriately dosed and inappropriately underdosed. In subgroup analysis, only apixaban demonstrated an increased incidence all-cause mortality (hazard ratio [HR] 1.24, 95% confidence interval [CI] 1.03-1.49) with inappropriate underdosing. There was no difference in the remaining clinical outcomes noted on subgroup analysis.

Conclusion: Underdosing of DOACs did not minimize risk of bleeding, systemic embolization or all-cause mortality in patients with AF. Inappropriate underdosing with apixaban in particular was associated with increased all-cause mortality.
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http://dx.doi.org/10.1016/j.amjmed.2020.12.022DOI Listing
June 2021

A Novel Method to Measure Transient Impairments in Cognitive Function During Acute Bouts of Hypoxia.

Aerosp Med Hum Perform 2020 Nov;91(11):839-844

Exposure to low oxygen environments (hypoxia) can impair cognitive function; however, the time-course of the transient changes in cognitive function is unknown. In this study, we assessed cognitive function with a cognitive test before, during, and after exposure to hypoxia. Nine participants (28 4 yr, 7 women) completed Conners Continuous Performance Test (CCPT-II) during three sequential conditions: 1) baseline breathing room air (fraction of inspired oxygen, Fo₂ 0.21); 2) acute hypoxia (Fo₂ 0.118); and 3) recovery after exposure to hypoxia. End-tidal gas concentrations (waveform capnography), heart rate (electrocardiography), frontal lobe tissue oxygenation (near infrared spectroscopy), and mean arterial pressure (finger photoplethysmography) were continuously assessed. Relative to baseline, during the hypoxia trial end-tidal (-30%) and cerebral (-9%) oxygen saturations were reduced. Additionally, the number of commission errors during the CCPT-II was greater during hypoxia trials than baseline trials (2.6 0.4 vs. 1.9 0.4 errors per block of CCPT-II). However, the reaction time and omission errors did not differ during the hypoxia CCPT-II trials compared to baseline CCPT-II trials. During the recovery CCPT-II trials, physiological indices of tissue hypoxia all returned to baseline values and number of commission errors during the recovery CCPT-II trials was not different from baseline CCPT-II trials. Oxygen concentrations were reduced (systemically and within the frontal lobe) and commission errors were increased during hypoxia compared to baseline. These data suggest that frontal lobe hypoxia may contribute to transient impairments in cognitive function during short exposures to hypoxia.
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http://dx.doi.org/10.3357/AMHP.5665.2020DOI Listing
November 2020

Sex Disparities in the Use and Outcomes of Temporary Mechanical Circulatory Support for Acute Myocardial Infarction-Cardiogenic Shock.

CJC Open 2020 Nov 5;2(6):462-472. Epub 2020 Jun 5.

Department of Physiology and Biomedical Engineering, Mayo Clinic, Rochester, Minnesota, USA.

Background: There are limited sex-specific data on patients receiving temporary mechanical circulatory support (MCS) for acute myocardial infarction-cardiogenic shock (AMI-CS).

Methods: All admissions with AMI-CS with MCS use were identified using the National Inpatient Sample from 2005 to 2016. Outcomes of interest included in-hospital mortality, discharge disposition, use of palliative care and do-not-resuscitate (DNR) status, and receipt of durable left ventricular assist device (LVAD) and cardiac transplantation.

Results: In AMI-CS admissions during this 12-year period, MCS was used more frequently in men-50.4% vs 39.5%; < 0.001. Of the 173,473 who received MCS (32% women), intra-aortic balloon pumps, percutaneous LVAD, extracorporeal membrane oxygenation, and ≥ 2 MCS devices were used in 92%, 4%, 1%, and 3%, respectively. Women were on average older (69 ± 12 vs 64 ± 13 years), of black race (10% vs 6%), and had more comorbidity (mean Charlson comorbidity index 5.0 ± 2.0 vs 4.5 ± 2.1). Women had higher in-hospital mortality than men (34% vs 29%, adjusted odds ratio [OR]: 1.19, 95% confidence interval [CI]: 1.16-1.23; < 0.001) overall, in intra-aortic balloon pumps users (OR: 1.20 [95% CI: 1.16-1.23]; < 0.001), and percutaneous LVAD users (OR: 1.75 [95% CI: 1.49-2.06]; < 0.001), but not in extracorporeal membrane oxygenation or ≥ 2 MCS device users ( > 0.05). Women had higher use of palliative care, DNR status, and discharges to skilled nursing facilities.

Conclusions: There are persistent sex disparities in the outcomes of AMI-CS admissions receiving MCS support. Women have higher in-hospital mortality, palliative care consultation, and use of DNR status.
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http://dx.doi.org/10.1016/j.cjco.2020.06.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7710954PMC
November 2020

Systemic Inflammatory Response Syndrome Is Associated With Increased Mortality Across the Spectrum of Shock Severity in Cardiac Intensive Care Patients.

Circ Cardiovasc Qual Outcomes 2020 12 7;13(12):e006956. Epub 2020 Dec 7.

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine (J.C.J., K.B.K.), Mayo Clinic, Rochester, MN.

Background: The systemic inflammatory response syndrome (SIRS) frequently occurs in patients with cardiogenic shock and may aggravate shock severity and organ failure. We sought to determine the association of SIRS with illness severity and survival across the spectrum of shock severity in cardiac intensive care unit (CICU) patients.

Methods: We retrospectively analyzed 8995 unique patients admitted to the Mayo Clinic CICU between 2007 and 2015. Patients with ≥2/4 SIRS criteria based on admission laboratory and vital sign data were considered to have SIRS. Patients were stratified by the 2019 Society for Cardiovascular Angiography and Interventions (SCAI) shock stages using admission data. The association between SIRS and mortality was evaluated across SCAI shock stage using logistic regression and Cox proportional-hazards models for hospital and 1-year mortality, respectively.

Results: The study population had a mean age of 67.5±15.2 years, including 37.2% women. SIRS was present in 33.9% of patients upon CICU admission and was more prevalent in advanced SCAI shock stages. Patients with SIRS had higher illness severity, worse shock, and more organ failure, with an increased risk of mortality during hospitalization (16.8% versus 3.8%; adjusted odds ratio, 2.1 [95% CI, 1.7-2.5]; <0.001) and at 1 year (adjusted hazard ratio, 1.4 [95% CI, 1.3-1.6]; <0.001). After multivariable adjustment, SIRS was associated with higher hospital and 1-year mortality among patients in SCAI shock stages A through D (all <0.01) but not SCAI shock stage E.

Conclusions: One-third of CICU patients meet clinical criteria for SIRS at the time of admission, and these patients have higher illness severity and worse outcomes across the spectrum of SCAI shock stages. The presence of SIRS identified CICU patients at increased risk of short-term and long-term mortality. Further study is needed to determine whether systemic inflammation truly drives SIRS in this population and whether patients with SIRS respond differently to supportive therapies for shock.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.006956DOI Listing
December 2020

Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review.

J Am Coll Cardiol 2020 12;76(23):2786-2794

Department of Cardiovascular Surgery, Baylor Health Care System, and Baylor Scott and White-The Heart Hospital-Plano Research Center, Plano, Texas.

The development of technology to treat unmet clinical patient needs in the United States has been an important focus for the U.S. Food and Drug Administration and the 2016 Congressional 21st Century Cures Act. In response, a program of early feasibility studies (EFS) has been developed. One of the important issues has been the outmigration of the development and testing of medical devices from the United States. The EFS committee has developed and implemented processes to address issues to develop strategies for early treatment of these patient groups. Initial implementation of the U.S. Food and Drug Administration EFS program has been successful, but residual significant problems have hindered the opportunity to take full advantage of the program. These include delays in gaining Institutional Review Board approval, timeliness of budget and contractual negotiations, and lack of access to and enrollment of study subjects. This paper reviews improvements that have been made to the U.S. EFS ecosystem and outlines potential approaches to address remaining impediments to program success.
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http://dx.doi.org/10.1016/j.jacc.2020.10.019DOI Listing
December 2020

Evaluation of Outcomes Following Pulmonary Artery Stenting in Fibrosing Mediastinitis.

Cardiovasc Intervent Radiol 2021 Mar 17;44(3):384-391. Epub 2020 Nov 17.

Vascular and Interventional Radiology, Mayo Clinic, Rochester, MN, USA.

Purpose: Fibrosing mediastinitis is a rare disease characterized by fibrosis of mediastinal structures with subsequent constriction of the bronchi and pulmonary vessels leading to potential respiratory compromise and death. Presently, there is no effective curative treatment with available treatments focused on reducing symptomology, including placement of pulmonary artery stents. Limited studies examine the use of stents in fibrosing mediastinitis. Given this knowledge gap, we assessed stent patency, hemodynamics, complications, and secondary outcomes of clinical improvement of pulmonary artery stenting for fibrosing mediastinitis.

Materials And Methods: Nine patients with fibrosing mediastinitis and pulmonary artery stents were retrospectively identified for inclusion (six females, three males; mean age 44.17 years, range 13-68; total 13 primary stents) from 2005 to 2018. Eight patients had history of PH. All patients had dyspnea on presentation. Seven patients had ventilation/perfusion studies demonstrating impairment. Results from computed tomography and echocardiography studies were collected to assess patency and physiologic response.

Results: All patients received initial angioplasty and stenting of the right pulmonary artery (10 stents). Two patients underwent additional left-sided intervention (3 stents). Stenting significantly increased lesion luminal patency (54-79%; P < 0.005) and reduced systolic pressure gradients across stenoses (mean -9.38 mmHg; P < 0.005). Primary patency at one year was 90%. Two stents received reintervention at 276 and 497 days. 89% reported improvement in dyspnea in the initial post-stenting period. There were no mortalities or major complications.

Conclusion: Pulmonary artery stenting improves vascular patency and provides symptomatic relief in patients with fibrosing mediastinitis.
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http://dx.doi.org/10.1007/s00270-020-02714-zDOI Listing
March 2021

Low-dose CT image and projection dataset.

Med Phys 2021 Feb 16;48(2):902-911. Epub 2020 Dec 16.

Department of Radiology, Mayo Clinic, Rochester, MN, USA.

Purpose: To describe a large, publicly available dataset comprising computed tomography (CT) projection data from patient exams, both at routine clinical doses and simulated lower doses.

Acquisition And Validation Methods: The library was developed under local ethics committee approval. Projection and image data from 299 clinically performed patient CT exams were archived for three types of clinical exams: noncontrast head CT scans acquired for acute cognitive or motor deficit, low-dose noncontrast chest scans acquired to screen high-risk patients for pulmonary nodules, and contrast-enhanced CT scans of the abdomen acquired to look for metastatic liver lesions. Scans were performed on CT systems from two different CT manufacturers using routine clinical protocols. Projection data were validated by reconstructing the data using several different reconstruction algorithms and through use of the data in the 2016 Low Dose CT Grand Challenge. Reduced dose projection data were simulated for each scan using a validated noise-insertion method. Radiologists marked location and diagnosis for detected pathologies. Reference truth was obtained from the patient medical record, either from histology or subsequent imaging.

Data Format And Usage Notes: Projection datasets were converted into the previously developed DICOM-CT-PD format, which is an extended DICOM format created to store CT projections and acquisition geometry in a nonproprietary format. Image data are stored in the standard DICOM image format and clinical data in a spreadsheet. Materials are provided to help investigators use the DICOM-CT-PD files, including a dictionary file, data reader, and user manual. The library is publicly available from The Cancer Imaging Archive (https://doi.org/10.7937/9npb-2637).

Potential Applications: This CT data library will facilitate the development and validation of new CT reconstruction and/or denoising algorithms, including those associated with machine learning or artificial intelligence. The provided clinical information allows evaluation of task-based diagnostic performance.
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http://dx.doi.org/10.1002/mp.14594DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7985836PMC
February 2021
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