Clinical Impact of Hypoattenuating Leaflet Thickening After Transcatheter Aortic Valve Replacement.

BACKGROUND: Hypoattenuated leaflet thickening (HALT), identified on functional cardiac computed tomography (CTA), can affect valve function and clinical outcomes. The objective of this study was to assess the impact of HALT on clinical outcomes in patients treated with transcatheter aortic valve replacement (TAVR). METHODS: In July 2015, Minneapolis Heart Institute implemented prospective screening of HALT at 30-day post-TAVR with CTA. Patients with evidence of HALT were recommended to initiate anticoagulation for 3 to 6 months with warfarin. Echocardiographic, ischemic, and bleeding outcomes were compared between HALT+ and HALT- patients. Survival rates were compared between HALT+ and HALT- patients using log-rank test, with Cox regression analysis used to identify variables independently associated with long-term death landmarked at time of CTA. This analysis included patients treated from July 1, 2015 to October 31, 2019. RESULTS: Of 856 patients undergoing TAVR during the study period, 638 (75%) underwent CTA post-TAVR (median time 31 [30-37] days). HALT+ was evident in 79 (12.3%). HALT+ patients were more likely prescribed warfarin at 1, 3, and 12 months (all P<0.001) and had similar gradients compared with HALT- patients. After a median follow-up of 2.2 years (1.5-3.2), HALT+ patients had increased mortality (30% versus 20%; P=0.001). In Cox regression analysis, presence of HALT (hazard ratio, 1.83 [95% CI, 1.13-2.97]; P=0.014) remained independently associated with long-term mortality. CONCLUSIONS: In a large, real-world cohort of patients receiving TAVR followed by systematic screening with CTA 30-days post-procedure, HALT was found in 12% of patients and independently associated with long-term mortality. Findings of this nonrandomized, observational cohort study require independent validation.

Temporal changes in patient characteristics and outcomes in ST-segment elevation myocardial infarction 2003-2018.

BACKGROUND: We sought to describe changes in demographic variables, process of care measures, and outcomes of patients treated in a regional ST-segment elevation myocardial infarction (STEMI) program over the last 15 years. METHODS: We describe demographic variables, process of care measures, and outcomes of patients treated in the program in various 5-year time periods: 2003-2007 (n = 1,821), 2008-2012 (n = 1,968), and 2013-2018 (n = 2,223). The primary outcome measures were in-hospital and 30-day mortality. RESULTS: Among 6,012 STEMI patients treated from 2003 to 2018 we observed a significant increase in mean age at presentation (62 ± 14 to 64 ± 13 years) and diabetes (14-22%, p < .01). The proportion of patients with cardiogenic shock (CS) and cardiac arrest (CA) pre-PCI increased significantly from 9.5% to 11.1% and 8.5% to 12.7% (p < .05), respectively. The median door-to-balloon (D2B) times decreased from 98 to 93 min and total ischemic time decreased from 202 to 185 min (all p < .05). Despite increased patient complexity, the proportion of nontransfer and transfer patients achieving D2B times consistent with guideline recommendations remained unchanged (for nontransfer patients 79-82%, p = .45 and for transfer patients 65-64%, p = .34). Among all STEMI patients, in-hospital mortality increased during the study period from 4.9 to 6.9% (p = .007) but remained stable (<2%) when CA and CS patients were excluded. CONCLUSIONS: Over the last 15 years, short-term STEMI mortality has increased despite improvements in care delivery metrics. Patients with CA and/or CS now represent 10% of STEMI patients and are responsible for 80% of deaths. Therefore, efforts to improve STEMI mortality, and metrics for assessing STEMI programs, should focus on these patients.

Statin Eligibility and Outpatient Care Prior to ST-Segment Elevation Myocardial Infarction.

BACKGROUND: The impact of the 2013 American College of Cardiology/American Heart Association cholesterol guidelines on statin eligibility in individuals otherwise destined to experience cardiovascular disease (CVD) events is unclear. METHODS AND RESULTS: We analyzed a prospective cohort of consecutive ST-segment elevation myocardial infarction (STEMI) patients from a regional STEMI system with data on patient demographics, low-density lipoprotein cholesterol levels, CVD risk factors, medication use, and outpatient visits over the 2 years prior to STEMI. We determined pre-STEMI eligibility according to American College of Cardiology/American Heart Association guidelines and the prior Third Report of the Adult Treatment Panel guidelines. Our sample included 1062 patients with a mean age of 63.7 (13.0) years (72.5% male), and 761 (71.7%) did not have known CVD prior to STEMI. Only 62.5% and 19.3% of individuals with and without prior CVD were taking a statin before STEMI, respectively. In individuals not taking a statin, median (interquartile range) low-density lipoprotein cholesterol levels in those with and without known CVD were low (108 [83, 138]  mg/dL and 110 [87, 133] mg/dL). For individuals not taking a statin, only 38.7% were statin eligible by ATP III guidelines. Conversely, 79.0% would have been statin eligible according to American College of Cardiology/American Heart Association guidelines. Less than half of individuals with (49.2%) and without (41.1%) prior CVD had seen a primary care provider during the 2 years prior to STEMI. CONCLUSIONS: In a large cohort of STEMI patients, application of American College of Cardiology/American Heart Association guidelines more than doubled pre-STEMI statin eligibility compared with Third Report of the Adult Treatment Panel guidelines. However, access to and utilization of health care, a necessity for guideline implementation, was suboptimal prior to STEMI.

Radiation dose and image quality of 70 kVp functional cardiovascular computed tomography imaging in congenital heart disease.

BACKGROUND: The use of cardiac computed tomography (CT) for quantification of ventricular function is limited by relatively high radiation dose. OBJECTIVES: The goal of this study was to describe the radiation exposure and image quality of 70 kVp functional cardiac CT in patients with congenital heart disease (CHD). METHODS: A retrospective review of 70 kVp ECG gated functional CT scans using tube current modulation was performed in CHD patients at a single institution. Quantitative and qualitative (assessed by myocardial segment, 1-4; 1 = optimal) image quality was determined. Per segment image quality was compared between thin (1.5 mm) and thick (8 mm) reconstructions and by patient age and size. Scan DLP was used to estimate radiation dose. RESULTS: 72 scans were performed during the time of review (7/2013-6/2015). Median patient age was 19.5 years (8.0, 27.1) and BMI was 20.1 (16.6, 24.5) kg/m(2). Median functional scan DLP was 78.8 (45.5, 98) and unadjusted and adjusted procedural mSv were 1.10 (0.64, 1.37) and 1.13 (0.90, 1.37). Image quality of 1 was achieved in all myocardial segments in >75% of scans. Patients with a weight ≥75 kg were more likely to have a scan achieve optimal image when using thick reconstructions compared to thin (81.3% vs. 43.8%; p = 0.028). CONCLUSIONS: Imaging of ventricular function with 70 kVp in CHD patients can be done with low radiation doses and provides diagnostic image quality, particularly for patients <75 kg. In larger patients, thicker slice reconstruction improved image quality.

Eligibility and utilization of implantable cardioverter-defibrillators in a regional STEMI system.

BACKGROUND: Studies have shown mortality benefit for implantable cardioverter-defibrillators (ICDs) in ST-elevation myocardial infarction (STEMI) patients with reduced left ventricular ejection fraction (LVEF), but contemporary eligibility and appropriate utilization of ICDs is unknown. OBJECTIVE: The purpose of this study was to determine the contemporary eligibility and appropriate utilization of ICDs post-STEMI. METHODS: Using the prospective Minneapolis Heart Institute regional STEMI registry, LVEF before discharge and at follow-up were stratified into 3 groups: normal (LVEF ≥50%), mildly reduced (LVEF 35%-49%), and severely reduced (LVEF <35%). RESULTS: From March 2003 to June 2012, 3626 patients were treated. Patients with in-hospital death (n = 187), ICD in place (n = 21), negative cardiac biomarkers (n = 337), and undocumented in-hospital LVEF (n = 9) were excluded, leaving 3072 patients in the final analysis, including 1833 (59.7%) with LVEF ≥50%, 875 (28.5%) with LVEF between 35% and 49%, and 364 (11.8%) with LVEF <35% before hospital discharge. Overall, 1029 patients (33.5%) underwent follow-up echocardiography ≥40 days post-STEMI, including 140 of the 364 patients (38.5%) discharged with LVEF <35%. In total, 73 patients (7.1%) with follow-up echocardiography ≥40 days post-STEMI met criteria for an ICD (68 LVEF ≤30%, 5 LVEF 30%-35%, and New York Heart Association class II or greater). Only 26 of these patients (35.6%) underwent ICD placement within 1 year post-STEMI. Overall, only 10% to 15% of potentially eligible patients had an ICD implemented. CONCLUSION: Rates of ICD implantation in appropriate STEMI patients after 40 days are low. Strategies are needed to identify and expand access to these high-risk patients.

Internal medicine point-of-care ultrasound assessment of left ventricular function correlates with formal echocardiography.

PURPOSE: Although focused cardiac ultrasonographic (FoCUS) examination has been evaluated in emergency departments and intensive care units with good correlation to formal echocardiography, accuracy for the assessment of left ventricular systolic function (LVSF) when performed by internal medicine physicians still needs independent evaluation. METHODS: This prospective observational study in a 640-bed, academic, quaternary care center, included 178 inpatients examined by 10 internal medicine physicians who had completed our internal medicine bedside ultrasound training program. The ability to estimate LVSF with FoCUS as "normal," "mild to moderately decreased," or "severely decreased" was compared with left ventricular ejection fraction (>50%, 31-49%, and <31%, respectively) from formal echocardiography interpreted by a cardiologist. RESULTS: Sensitivity and specificity of FoCUS for any degree of LVSF impairment were 0.91 (95% confidence interval [CI] 0.80, 0.97) and 0.88 (95% CI 0.81, 0.93), respectively. The interrater agreement between internal medicine physician-performed FoCUS and formal echocardiography for any LVSF impairment was "good/substantial" with κ = 0.77 (p < 0.001), 95% CI (0.67, 0.87). Formal echocardiography was classified as "technically limited due to patient factors" in 20% of patients; however, echogenicity was sufficient in 100% of FoCUS exams to classify LVSF. CONCLUSIONS: Internal medicine physicians using FoCUS identify normal versus decreased LVSF with high sensitivity, specificity, and "good/substantial" interrater agreement when compared with formal echocardiography. These results support the role of cardiac FoCUS by properly trained internal medicine physicians for discriminating normal from reduced LVSF.

Comparison of functional recovery following percutaneous coronary intervention for ST elevation myocardial infarction in three age groups (<70, 70 to 79, and ≥80 years).

Functional outcomes of elderly patients ≥80 years who undergo percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI) are unknown. Registry data indicate that up to 55% of elderly patients with STEMI do not receive reperfusion therapy despite a suggested mortality benefit, and only limited data are available regarding outcomes in elderly patients treated with primary PCI. Therefore, prospective data from a regional STEMI transfer program were analyzed to determine major adverse cardiac events, length of stay, and discharge status of consecutive patients with STEMI ≥80 years from March 2003 to November 2006. Of the 1,323 consecutive patients with STEMI treated in this regional STEMI system from March 2003 to November 2006, 199 (15.0%) were ≥80 years old. In-hospital mortality in elderly patients was 11.6%, with a 1-year mortality rate of 25.6%. Of the 166 patients with age ≥80 who lived independently or in assisted living before hospital admission and survived, 150 (90.4%) were discharged to a similar living situation or projected to such a living situation after temporary nursing home care. The median length of hospital stay was 4 days for these patients. In conclusion, elderly patients with age ≥80 receiving PCI for STEMI in a regional STEMI program have short hospital stays and excellent functional recovery on the basis of a very high rate of return to a similar previous living situation.

Long-term follow-up of older patients with Mobitz type I second degree atrioventricular block.

OBJECTIVE: To examine the long-term survival of older patients with Mobitz I second degree atrioventricular (AV) block. DESIGN: Retrospective cohort study. Propensity score adjustment for requiring a cardiac implantable electronic device (CIED) was performed. Multivariable Cox regression analysis was used. SETTING: Tertiary care referral centre. PATIENTS: We examined 299 older patients (age >45 years) with Mobitz I second degree AV block on ECG at the Minneapolis Veterans Affairs Medical Center from 1992 to 2010. MAIN OUTCOME MEASURE: Survival. RESULTS: The average age of patients was 75±9 years; 99% were male; 59% had coronary heart disease; 44% had heart failure. 141 (47%) patients required CIED, of which 17 were implantable cardioverter-defibrillators (ICDs). CIEDs were implanted a median of 110 days after the ECG for symptomatic bradycardia, high-degree AV block or prevention of sudden cardiac death. Patients with CIED had greater cardiac co-morbidity than those without CIED. After a median 3.3 years of follow-up (range 3 days to 19 years), 190 (64%) patients died. Patients with CIED had longer survival than those without CIED (p=0.001). In propensity-adjusted multivariable Cox regression analysis, CIED implantation was associated with a 46% reduction in mortality (HR 0.54, 95% CI 0.35 to 0.82; p=0.004). Excluding 17 patients with ICDs did not alter the results. CONCLUSIONS: In this retrospective cohort study of older male patients with Mobitz I AV block on ECG, CIED implantation was associated with longer survival.

Causes of delay and associated mortality in patients transferred with ST-segment-elevation myocardial infarction.

BACKGROUND: Regional ST-segment-elevation myocardial infarction systems are being developed to improve timely access to primary percutaneous coronary intervention (PCI). System delays may diminish the mortality benefit achieved with primary PCI in ST-segment-elevation myocardial infarction patients, but the specific reasons for and clinical impact of delays in patients transferred for PCI are unknown. METHODS AND RESULTS: This was a prospective, observational study of 2034 patients transferred for primary PCI at a single center as part of a regional ST-segment-elevation myocardial infarction system from March 2003 to December 2009. Despite long-distance transfers, 30.4% of patients (n=613) were treated in ≤ 90 minutes and 65.7% (n=1324) were treated in ≤ 120 minutes. Delays occurred most frequently at the referral hospital (64.0%, n=1298), followed by the PCI center (15.7%, n=317) and transport (12.6%, n=255). For the referral hospital, the most common reasons for delay were awaiting transport (26.4%, n=535) and emergency department delays (14.3%, n=289). Diagnostic dilemmas (median, 95.5 minutes; 25th and 75th percentiles, 72-127 minutes) and nondiagnostic initial ECGs (81 minutes; 64-110.5 minutes) led to delays of the greatest magnitude. Delays caused by cardiac arrest and/or cardiogenic shock had the highest in-hospital mortality (30.6%), in contrast with nondiagnostic initial ECGs, which, despite long treatment delays, did not affect mortality (0%). Significant variation in both the magnitude and clinical impact of delays also occurred during the transport and PCI center segments. CONCLUSIONS: Treatment delays occur even in efficient systems for ST-segment-elevation myocardial infarction care. The clinical impact of specific delays in interhospital transfer for PCI varies according to the cause of the delay.

Impact of age on treatment and outcomes in ST-elevation myocardial infarction.

OBJECTIVES: We hypothesized that older patients in a regional ST-elevation myocardial infarction (STEMI) transfer program would attain comparable treatment to younger patients. BACKGROUND: Older patients have been either excluded or underrepresented in STEMI clinical trials. Observational studies suggest that these patients are less likely to receive adjunctive pharmacologies and reperfusion therapy-thrombolysis or percutaneous coronary intervention (PCI)-and therapy is frequently delayed. METHODS: We identified a consecutive series of 2,262 STEMI patients (March 2003-December 2008) who either presented or were transferred to Abbott Northwestern Hospital for PCI (<65 years [n = 1285], 65-74 years [n = 436], 75-84 years [n = 381], and ≥85 years [n = 160]). Main outcome measures included time-to-reperfusion therapy, adjunctive medications received, and all-cause mortality. RESULTS: Overall time-to-reperfusion therapy was similar across age strata-94 minutes (<65 years), 101 minutes (65-74 years), 106 minutes (75-84 years), and 103 minutes (≥85 years). No difference in adjunctive antiplatelet or anticoagulant medications was seen at hospital admission, and only slight differences in standard post-myocardial infarction medication use were seen by age at hospital discharge. Age was an independent predictor of in-hospital and yearly mortality up to 5 years (1-year mortality 3.4% [<65 years], 9.2% [65-74 years], 15.2% [75-84 years], and 28.9% [≥85 years]; P < .0001). CONCLUSIONS: Older patients receive similar care to younger patients when treated in a regional STEMI transfer program. Although all-cause mortality in the elderly is increased, the absolute rates are lower than previously established. Our data suggest primary PCI (including transfer) can be applied to all appropriate STEMI patients, regardless of age.

Pharmaco-invasive strategies expand access to percutaneous coronary intervention in ST-elevation myocardial infarction.

Primary percutaneous coronary intervention (PCI) is the preferred method of reperfusion in patients with ST-elevation myocardial infarction (STEMI). Therefore, increasing timely access to PCI is a major national focus. The majority of United States hospitals are not PCI capable, which has stimulated the development of regional STEMI programs using standardized protocols and organized transfer systems. These regional STEMI systems have improved treatment times and clinical outcomes, leading to a recent class I recommendation in the American College of Cardiology/American Heart Association guidelines to develop STEMI systems of care. Despite this, less than 15% of patients transferred from non-PCI hospitals to PCI centers have total door-to-balloon times less than 2 hours. We review the therapeutic options for the STEMI patient with expected delay to PCI focusing on recent pharmacoinvasive trials. Based on these trial results, recent guidelines recommend early transfer and cardiac catheterization for patients treated with fibrinolytic therapy.

A regional system to provide timely access to percutaneous coronary intervention for ST-elevation myocardial infarction.

BACKGROUND: Percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) is superior to fibrinolysis when performed in a timely manner in high-volume centers. Recent European trials suggest that transfer for PCI also may be superior to fibrinolysis and increase access to PCI. In the United States, transfer times are consistently long; therefore, many believe a transfer for PCI strategy for STEMI is not practical. METHODS AND RESULTS: We developed a standardized PCI-based treatment system for STEMI patients from 30 hospitals up to 210 miles from a PCI center. From March 2003 to November 2006, 1345 consecutive STEMI patients were treated, including 1048 patients transferred from non-PCI hospitals. The median first door-to-balloon time for patients <60 miles (zone 1) and 60 to 210 miles (zone 2) from the PCI center was 95 minutes (25th and 75th percentiles, 82 and 116 minutes) and 120 minutes (25th and 75th percentiles, 100 and 145 minutes), respectively. Despite the high-risk unselected patient population (cardiogenic shock, 12.3%; cardiac arrest, 10.8%; and elderly [> or =80 years of age], 14.6%), in-hospital mortality was 4.2%, and median length of stay was 3 days. CONCLUSIONS: Rapid transfer of STEMI patients from community hospitals up to 210 miles from a PCI center is safe and feasible using a standardized protocol with an integrated transfer system.

Comparison of safety and efficacy of sirolimus-eluting stents versus bare metal stents in patients with ST-segment elevation myocardial infarction.

Sirolimus-eluting stents (SESs) are superior to bare metal stents (BMSs) for percutaneous coronary intervention, but data regarding SESs in ST-segment elevation myocardial infarction (STEMI) are limited. We investigated the clinical outcomes of patients with STEMI who were treated with SESs. We measured clinical characteristics and acute and long-term outcomes in 306 consecutive patients with STEMI who received a SES (n = 156) or a BMS (n = 150). Patients were followed for death, nonfatal reinfarction, and target vessel revascularization. Patients with SESs had a 0.6% in-hospital mortality rate versus 5.3% in patients with BMSs (p = 0.015). Six-month mortality rates were 1.9% (SES) and 10.1% (BMS, p = 0.003). At 6 months, patients with SESs were less likely to have target vessel revascularization (1.3% vs 8.1%, p = 0.005) and achieve the composite end point (3.2% vs 16.1%, p = 0.0001). No subacute thrombosis or clinical restenosis occurred in the SES group. Patients who received BMSs were older, received more stents, and had more myocardial damage, worse renal function, and lower ejection fractions than did those in the SES group. By multivariate discriminant analysis, stent type (SES vs BMS) was the most significant determinant of the 6-month composite end point (p = 0.01) and the need for target vessel revascularization (p = 0.02). In conclusion, SESs are safe and effective in STEMI at 6 months.