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1.
Struct Heart ; 8(2): 100237, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38481714

ABSTRACT

Background: The eligibility and potential benefit of transcatheter edge-to-edge repair (TEER) in addition to guideline-directed medical therapy to treat moderate-severe or severe secondary mitral regurgitation (MR) has not been reported in a contemporary heart failure (HF) population. Methods: Eligibility for TEER based on Food and Drug Administration (FDA) labeling: (1) HF symptoms, (2) moderate-severe or severe MR, (3) left ventricular ejection fraction (LVEF) 20% to 50%, (4) left ventricular end-systolic dimension 7.0 cm, and (5) receiving GDMT (blocker + angiotensin-converting enzyme inhibitor/angiotensin receptor blocker). The proportion (%) of patients eligible for TEER. The hypothetical number needed to treat to prevent or postpone adverse outcomes was estimated using relative risk reductions from published hazard ratios in the registration trial and the observed event rates. Results: We identified 50,841 adults with HF and known LVEF. After applying FDA criteria, 2461 patients (4.8%) were considered eligible for transcatheter mitral valve replacement (FDA+), with the vast majority of patients excluded (FDA-) based on a lack of clinically significant MR (N = 47,279). FDA+ patients had higher natriuretic peptide levels and were more likely to have a prior HF hospitalization compared to FDA- patients. Although FDA+ patients had a more dilated left ventricle and lower LVEF, median (25th-75th) left ventricular end-systolic dimension (cm) was low at 4.4 (3.7-5.1) and only 30.8% had severely reduced LVEF. FDA+ patients were at higher risk of HF-related morbidity and mortality. The estimated number needed to treat to potentially prevent or postpone all-cause hospitalization was 4.4, 8.8 for HF hospitalization, and 5.3 for all-cause death at 24 months in FDA+ patients. Conclusions: There is a low prevalence of TEER eligibility based on FDA criteria primarily due to absence of moderate-severe or severe MR. FDA+ patients are a high acuity population and may potentially derive a robust clinical benefit from TEER based on pivotal studies. Additional research is necessary to validate the scope of eligibility and comparative effectiveness of TEER in real-world populations.

2.
Am Heart J ; 266: 32-47, 2023 12.
Article in English | MEDLINE | ID: mdl-37553045

ABSTRACT

BACKGROUND: Contemporary outcomes for aortic stenosis (AS) and the association between physician-assessed AS severity and quantitative parameters is poorly understood. We aimed to evaluate AS natural history, compare outcomes for physicians' AS assessment vs. quantitative parameters, and identify AS parameters with the most explanatory power. METHODS: We ascertained physician-assessed AS severity, echocardiographic parameters, and clinical data for 546,769 patients from 2008-2018, examined multivariable associations of physician-assessed AS severity and number of quantitative severe AS parameters with death, cardiovascular hospitalization, and aortic valve replacement, and estimated the relative contribution of different quantitative AS parameters on outcomes. RESULTS: Among 49,604 AS patients (mean [SD] age 77 [11] years), 17.6% had moderate, 3.6% moderate-severe, and 9.4% severe AS. During median 3.7 [IQR 1.7-6.8] years, physician-assessed AS severity strongly correlated with outcomes, with moderate AS patients tracking closest to mild AS, and moderate-to-severe AS patients more comparable to severe AS. Although the number of quantitative severe AS parameters strongly predicted outcomes (adjusted HR [95% CI] for death 1.40 [1.34-1.46], 1.70 [1.56-1.85], and 1.78 [1.63-1.94] for 1, 2, and 3 parameters, respectively), aortic valve area <1.0 cm2 was the most frequent severe AS parameter, explained the largest relative contribution (67%), and was common in patients classified as moderate (21%) or moderate-severe (56%) AS. CONCLUSIONS: Physician-assessed AS severity predicts outcomes, with cumulative effects for each severe AS parameter. Moderate AS includes a wide spectrum of patients, with discordant AVA <1.0 cm2 being both common and predictive. Better identification of non-classical severe AS phenotypes may improve outcomes.


Subject(s)
Aortic Valve Stenosis , Humans , Aged , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Echocardiography , Catheters , Severity of Illness Index
3.
Struct Heart ; 7(4): 100166, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37520133

ABSTRACT

Background: Transcatheter aortic valve replacement (TAVR) may be used to urgently or emergently treat severe aortic stenosis, but outcomes for this high-risk population have not been well-characterized. We sought to describe the incidence, clinical characteristics, and outcomes of patients undergoing urgent or emergent vs. elective TAVR. Methods: We identified all adults who received TAVR for primary aortic stenosis between 2013 and 2019 within an integrated health care delivery system in Northern California. Elective or urgent/emergent procedure status was based on standard Society of Thoracic Surgeons definitions. Data were obtained from electronic health records, the Society of Thoracic Surgeons-American College of Cardiology Transcatheter Valve Therapy Registry, and state/national reporting databases. Logistic regression and Cox proportional hazard models were performed. Results: Among 1564 eligible adults that underwent TAVR, 81 (5.2%) were classified as urgent/emergent. These patients were more likely to have heart failure (63.0% vs. 47.4%), reduced left ventricular ejection fraction (21.0% vs. 11.8%), or a prior aortic valve balloon valvuloplasty (13.6% vs. 5.0%) and experienced higher unadjusted rates of 30-day and 1-year morbidity and mortality. Urgent/emergent TAVR status was independently associated with non-improved quality of life at 30-days (hazard ratio, 4.87; p < 0.01) and acute kidney injury within 1-year post-TAVR (hazard ratio, 2.11; p = 0.01). There was not a significant difference in adjusted 1-year mortality with urgent/emergent TAVR. Conclusions: Urgent/emergent TAVR status was uncommon and associated with high-risk clinical features and higher unadjusted rates of short- and long-term morbidity and mortality. Procedure status may be useful to identify patients less likely to experience significant short term improvement in health-related quality of life post-TAVR.

4.
J Interv Cardiol ; 2023: 1147352, 2023.
Article in English | MEDLINE | ID: mdl-37251366

ABSTRACT

Background: Randomized trials have shown superiority of the novel P2Y12 inhibitors over clopidogrel in patients with acute coronary syndrome (ACS), but clinical benefit in the community remains controversial. Our objective was to compare the safety and efficacy of clopidogrel to ticagrelor and prasugrel in patients with ACS undergoing percutaneous coronary intervention (PCI) in a real-world population. Methods: We conducted a retrospective cohort study of patients with ACS who underwent PCI and were discharged with clopidogrel, ticagrelor, or prasugrel from 2012 to 2018 within Kaiser Permanente Northern California. We used Cox proportional hazard models with propensity-score matching to evaluate the association of the P2Y12 agent with the primary outcomes of all-cause mortality, myocardial infarction (MI), stroke, and bleeding events. Results: The study included 15,476 patients (93.1% on clopidogrel, 3.6% on ticagrelor and 3.2% on prasugrel). Compared to the clopidogrel group, ticagrelorand prasugrel patients were younger with less comorbidities. In multivariable models with propensity-score matching, we found a lower risk of all-cause mortality in the ticagrelor vs the clopidogrel group (HR (95% CI) 0.43 (0.20-0.92)), but no differences in the other endpoints, and no difference between prasugrel and clopidogrel among any endpoints. A larger proportion of patients on ticagrelor or prasugrel switched to an alternative P2Y12 agent vs. clopidogrel (p < 0.01), and a higher level of persistence was seen among patients on clopidogrel vs. ticagrelor (p = 0.03) or prasugrel (p < 0.01). Conclusion: Among patients with ACS who underwent PCI, we observed a lower risk of all-cause mortality in patients treated with ticagrelor vs clopidogrel, but no difference in other clinical endpoints nor any differences in endpoints between prasugrel vs. clopidogrel users. These results suggest that further study is needed to identify an optimal P2Y12 inhibitor in a real-world population.


Subject(s)
Acute Coronary Syndrome , Percutaneous Coronary Intervention , Humans , Clopidogrel/therapeutic use , Ticagrelor/therapeutic use , Acute Coronary Syndrome/drug therapy , Prasugrel Hydrochloride/adverse effects , Purinergic P2Y Receptor Antagonists/adverse effects , Retrospective Studies , Percutaneous Coronary Intervention/methods , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Ischemia , Platelet Aggregation Inhibitors/adverse effects , Treatment Outcome
5.
Int J Cardiol ; 384: 107-111, 2023 08 01.
Article in English | MEDLINE | ID: mdl-37119944

ABSTRACT

BACKGROUND: Data on the epidemiology of aortic stenosis (AS) are primarily derived from single center experiences and administrative claims data that do not delineate by degree of disease severity. METHODS: An observational cohort study of adults with echocardiographic AS was conducted January 1st, 2013-December 31st, 2019 at an integrated health system. The presence/grade of AS was based on physician interpretation of echocardiograms. RESULTS: A total of 66,992 echocardiogram reports for 37,228 individuals were identified. The mean ± standard deviation (SD) age was 77.5 ± 10.5, 50.5% (N = 18,816) were women, and 67.2% (N = 25,016) were non-Hispanic whites. The age-standardized AS prevalence increased from 589 (95% Confidence Interval [CI] 580-598) to 754 (95% CI 744-764) cases per 100,000 during the study period. The age-standardized AS prevalences were similar in magnitude among non-Hispanic whites (820, 95% CI 806-834), non-Hispanic blacks (728, 95% CI 687-769), and Hispanics (789, 95% CI 759-819) and substantially lower for Asian/Pacific Islanders (511, 95% CI 489-533). Finally, the distribution of AS by degree of severity remained relatively unchanged over time. CONCLUSIONS AND RELEVANCE: The population prevalence of AS has grown considerably over a short timeframe although the distribution of AS severity has remained stable.


Subject(s)
Aortic Valve Stenosis , Female , Humans , Male , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/epidemiology , Black or African American , Hispanic or Latino , Prevalence , United States , White , Aged , Aged, 80 and over , Asian American Native Hawaiian and Pacific Islander
6.
Am Heart J ; 256: 60-72, 2023 02.
Article in English | MEDLINE | ID: mdl-36372246

ABSTRACT

BACKGROUND: The approved use of transcatheter aortic valve replacement (TAVR) for aortic stenosis has expanded substantially over time. However, gaps remain with respect to accurately delineating risk for poor clinical and patient-centered outcomes. Our objective was to develop prediction models for 30-day clinical and patient-centered outcomes after TAVR within a large, diverse community-based population. METHODS: We identified all adults who underwent TAVR between 2013-2019 at Kaiser Permanente Northern California, an integrated healthcare delivery system, and were monitored for the following 30-day outcomes: all-cause death, improvement in quality of life, all-cause hospitalizations, all-cause emergency department (ED) visits, heart failure (HF)-related hospitalizations, and HF-related ED visits. We developed prediction models using gradient boosting machines using linked demographic, clinical and other data from the Society for Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT Registry and electronic health records. We evaluated model performance using area under the curve (AUC) for model discrimination and associated calibration plots. We also evaluated the association of individual predictors with outcomes using logistic regression for quality of life and Cox proportional hazards regression for all other outcomes. RESULTS: We identified 1,565 eligible patients who received TAVR. The risks of adverse 30-day post-TAVR outcomes ranged from 1.3% (HF hospitalizations) to 15.3% (all-cause ED visits). In models with the highest discrimination, discrimination was only moderate for death (AUC 0.60) and quality of life (AUC 0.62), but better for HF-related ED visits (AUC 0.76). Calibration also varied for different outcomes. Importantly, STS risk score only independently predicted death and all-cause hospitalization but no other outcomes. Older age also only independently predicted HF-related ED visits, and race/ethnicity was not significantly associated with any outcomes. CONCLUSIONS: Despite using a combination of detailed STS/ACC TVT Registry and electronic health record data, predicting short-term clinical and patient-centered outcomes after TAVR remains challenging. More work is needed to identify more accurate predictors for post-TAVR outcomes to support personalized clinical decision making and monitoring strategies.


Subject(s)
Aortic Valve Stenosis , Heart Failure , Transcatheter Aortic Valve Replacement , Humans , United States , Transcatheter Aortic Valve Replacement/methods , Quality of Life , Treatment Outcome , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/epidemiology , Risk Factors , Heart Failure/etiology , Registries , Aortic Valve/surgery
7.
Am J Cardiol ; 132: 44-51, 2020 10 01.
Article in English | MEDLINE | ID: mdl-32762964

ABSTRACT

The optimal duration of dual antiplatelet therapy (DAPT) after treatment of chronic total occlusions (CTO) with percutaneous coronary intervention (PCI) is unknown. We aimed to determine if extended (> 12 months) DAPT was associated with a net clinical benefit. The study population included patients who underwent successful CTO PCI within Kaiser Permanente Northern California between 2009 and 2016. Baseline demographic, clinical, and procedural characteristics were compared for patients on DAPT ≤ versus > 12 months. Clinical outcomes (death, myocardial infarction (MI), and ≥ Academic Research Consortium type 3a bleeding) were compared beginning 12 months after PCI using Cox proportional hazards models. We also adjudicated individual causes of death. 1,069 patients were followed for a median of 3.6 years (Interquartile Range = 2.2 to 5.5) following CTO PCI. Patients on DAPT ≤ 12 months (n = 597, 56%) were more likely to have anemia, end stage renal disease, and previous MI. After adjustment for between group differences, > 12 months of DAPT was associated with lower death or MI (hazard ratio [HR]: 0.66; 95% confidence interval [CI]: 0.47 to 0.93) and lower death (HR: 0.54; 95% CI: 0.36 to 0.82). There were no associations with MI (HR: 0.91; 95% CI: 0.55 to 1.5) or bleeding (HR 1.1; 95% CI: 0.50 to 2.4), but a numerically higher proportion of patients on shorter v. longer DAPT died of a cardiovascular cause (37% vs 20%, p = 0.10). In conclusion, > 12 months of DAPT was associated with lower death or MI, without an increase in bleeding. Prospective studies are needed to evaluate the optimal duration of DAPT in this unique subgroup.


Subject(s)
Coronary Occlusion/therapy , Dual Anti-Platelet Therapy/methods , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors/therapeutic use , California/epidemiology , Chronic Disease , Coronary Angiography , Coronary Occlusion/diagnosis , Coronary Occlusion/mortality , Drug Administration Schedule , Female , Follow-Up Studies , Humans , Male , Middle Aged , Postoperative Period , Prognosis , Retrospective Studies , Survival Rate/trends , Time Factors
8.
Am J Cardiol ; 130: 37-45, 2020 09 01.
Article in English | MEDLINE | ID: mdl-32665131

ABSTRACT

Coronary artery perforation (CP) is a rare but potentially life-threatening complication of percutaneous coronary intervention (PCI). Given the marked increase in high-risk and complex PCIs, careful review and understanding of PCI complications may help to improve procedural and clinical outcomes. Our aim was to study the trends, predictors and outcomes of CP in the contemporary era. This cross-sectional multicenter analysis included data collected from institutions participating in the National Cardiovascular Data Registry CathPCI Registry between July 2009 and June 2015. Multivariable logistic regression models were created to identify predictors of CP and compare the in-hospital outcomes of CP and non-CP patients. Of 3,759,268 PCIs performed during the study period, there were 13,779 CP (0.37%). During the study period, the proportion of PCI that developed CP remained unchanged (0.33% to 0.4%) (p for trend 0.16). Chronic total occlusion (CTO) PCI as percentage of total PCI volume increased over the study period (3% to 4%) (p for trend <0.001) with a concomitant significant increase in CTOs with perforation (1.2% to 1.5%, p for trend = 0.02). CTO PCI (Odds Ratio [OR] 2.59) female gender (OR 1.38), saphenous vein graft PCI (OR 1.2), ACC Type C lesion (1.48), cardiogenic shock on presentation (1.15), and use of atherectomy (laser/ rotational) (OR 2.38) were significant predictors of CP. CP patients had significantly higher rates of cardiogenic shock (7.73% vs 1.02%), tamponade (9.6% vs 0.05%) and death (4.87% vs 1.14%) compared with those without CP. Strongest predictors of any adverse events amongst CP were cardiogenic shock (OR 3.93), cardiac arrest (OR 2.02) and use of atherectomy device (OR 2.5). Use of covered stents was also strongly associated with adverse events (OR 3.67) reflecting severity of these CPs. CP in CTO PCI had higher rates of any adverse event than non-CTO CP (26.8% vs 22%, p < 0.001). However non-CTO CP had higher rates of coronary artery bypass grafting (CABG) (urgent, emergent, or salvage) (5.8% vs 4.5%, p = 0.03) and death (6.9% vs 5.6%, p = 0.04). CP in CABG PCI had fewer adverse events compared with those without previous CABG (16.1% vs 24.7%). In a large real world experience, we identified several clinical and procedural factors associated with increased risk of CP and adverse outcomes. The trends in CP remained constant over the study period.


Subject(s)
Coronary Vessels/injuries , Intraoperative Complications/epidemiology , Intraoperative Complications/etiology , Percutaneous Coronary Intervention/adverse effects , Aged , Coronary Occlusion/surgery , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Registries , Risk Assessment
10.
J Am Heart Assoc ; 6(10)2017 Oct 05.
Article in English | MEDLINE | ID: mdl-28982671

ABSTRACT

BACKGROUND: ECG left ventricular hypertrophy (LVH) is a well-known predictor of cardiovascular disease. However, no prior study has characterized patterns of presence/absence of ECG LVH ("ECG LVH trajectories") across the adult lifespan in both sexes and across ethnicities. We examined: (1) correlates of ECG LVH trajectories; (2) the association of ECG LVH trajectories with incident coronary heart disease, transient ischemic attack, ischemic stroke, hemorrhagic stroke, and heart failure; and (3) reclassification of cardiovascular disease risk using ECG LVH trajectories. METHODS AND RESULTS: We performed a cohort study among 75 412 men and 107 954 women in the Northern California Kaiser Permanente Medical Care Program who had available longitudinal exposures of ECG LVH and covariates, followed for a median of 4.8 (range <1-9.3) years. ECG LVH was measured by Cornell voltage-duration product. Adverse trajectories of ECG LVH (persistent, new development, or variable pattern) were more common among blacks and Native American men and were independently related to incident cardiovascular disease with hazard ratios ranging from 1.2 for ECG LVH variable pattern and transient ischemic attack in women to 2.8 for persistent ECG LVH and heart failure in men. ECG LVH trajectories reclassified 4% and 7% of men and women with intermediate coronary heart disease risk, respectively. CONCLUSIONS: ECG LVH trajectories were significant indicators of coronary heart disease, stroke, and heart failure risk, independently of level and change in cardiovascular disease risk factors, and may have clinical utility.


Subject(s)
Electrocardiography , Health Status Disparities , Hypertrophy, Left Ventricular/diagnosis , Racial Groups , Adult , Black or African American , Aged , Aged, 80 and over , Asian , Brain Ischemia/diagnosis , Brain Ischemia/ethnology , California/epidemiology , Comorbidity , Coronary Disease/diagnosis , Coronary Disease/ethnology , Databases, Factual , Female , Health Maintenance Organizations , Heart Failure/diagnosis , Heart Failure/ethnology , Hispanic or Latino , Humans , Hypertrophy, Left Ventricular/ethnology , Hypertrophy, Left Ventricular/physiopathology , Indians, North American , Intracranial Hemorrhages/diagnosis , Intracranial Hemorrhages/ethnology , Ischemic Attack, Transient/diagnosis , Ischemic Attack, Transient/ethnology , Life Style/ethnology , Male , Middle Aged , Native Hawaiian or Other Pacific Islander , Predictive Value of Tests , Prognosis , Risk Factors , Stroke/diagnosis , Stroke/ethnology , Time Factors , White People
11.
J Am Coll Cardiol ; 66(19): 2104-2113, 2015 Nov 10.
Article in English | MEDLINE | ID: mdl-26541921

ABSTRACT

BACKGROUND: Up to 65% of patients with ST-segment elevation myocardial infarction (STEMI) have multivessel coronary artery disease (MVCAD). Long-term health status of STEMI patients after multivessel revascularization is unknown. OBJECTIVES: This study investigated the relationship between multivessel revascularization and health status outcomes (symptoms and quality of life [QoL]) in STEMI patients with MVCAD. METHODS: Using a U.S. myocardial infarction registry and the Seattle Angina Questionnaire (SAQ), we determined the health status of patients with STEMI and MVCAD at the time of STEMI and 1 year later. We assessed the association of multivessel revascularization during index hospitalization with 1-year health status using multivariable linear regression analysis, and also examined demographic, clinical, and angiographic factors associated with multivessel revascularization. RESULTS: Among 664 STEMI patients with MVCAD, 251 (38%) underwent multivessel revascularization. Most revascularizations were staged during the index hospitalization (64.1%), and 8.0% were staged after discharge, with 27.9% performed during primary percutaneous coronary intervention. Multivessel revascularization was associated with age and more diseased vessels. At 1 year, multivessel revascularization was independently associated with improved symptoms (4.5 points higher SAQ angina frequency score; 95% confidence interval [CI]: 1.0 to 7.9) and QoL (6.6 points higher SAQ QoL score; 95% CI: 2.7 to 10.6). One-year mortality was not different between those who did and did not undergo multivessel revascularization (3.6% vs. 3.4%; log-rank test p = 0.88). CONCLUSIONS: Multivessel revascularization improved angina and QoL in STEMI patients with MVCAD. Patient-centered outcomes should be considered in future trials of multivessel revascularization.


Subject(s)
Coronary Artery Disease/surgery , Electrocardiography , Health Status , Myocardial Infarction/surgery , Myocardial Revascularization/methods , Registries , Coronary Artery Disease/complications , Coronary Artery Disease/physiopathology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myocardial Infarction/complications , Myocardial Infarction/physiopathology , Prospective Studies , Treatment Outcome
13.
BMJ ; 350: h1302, 2015 Mar 24.
Article in English | MEDLINE | ID: mdl-25805158

ABSTRACT

OBJECTIVE: To examine whether prospective bleeding risk estimates for patients undergoing percutaneous coronary intervention could improve the use of bleeding avoidance strategies and reduce bleeding. DESIGN: Prospective cohort study comparing the use of bleeding avoidance strategies and bleeding rates before and after implementation of prospective risk stratification for peri-procedural bleeding. SETTING: Nine hospitals in the United States. PARTICIPANTS: All patients undergoing percutaneous coronary intervention for indications other than primary reperfusion for ST elevation myocardial infarction. MAIN OUTCOME MEASURES: Use of bleeding avoidance strategies, including bivalirudin, radial approach, and vascular closure devices, and peri-procedural bleeding rates, stratified by bleeding risk. Observed changes were adjusted for changes observed in a pool of 1135 hospitals without access to pre-procedural risk stratification. Hospital level and physician level variability in use of bleeding avoidance strategies was examined. RESULTS: In a comparison of 7408 pre-intervention procedures with 3529 post-intervention procedures, use of bleeding avoidance strategies within intervention sites increased with pre-procedural risk stratification (odds ratio 1.81, 95% confidence interval 1.44 to 2.27), particularly among higher risk patients (2.03, 1.58 to 2.61; 1.41, 1.09 to 1.83 in low risk patients, after adjustment for control sites; P for interaction = 0.05). Bleeding rates within intervention sites were significantly lower after implementation of risk stratification (1.0% v 1.7%; odds ratio 0.56, 0.40 to 0.78; 0.62, 0.44 to 0.87, after adjustment); the reduction in bleeding was greatest in high risk patients. Marked variability in use of bleeding avoidance strategies was observed across sites and physicians, both before and after implementation. CONCLUSIONS: Prospective provision of individualized bleeding risk estimates was associated with increased use of bleeding avoidance strategies and lower bleeding rates. Marked variability between providers highlights an important opportunity to improve the consistency, safety, and quality of care. Study registration Clinicaltrials.gov NCT01383382.


Subject(s)
Blood Loss, Surgical/prevention & control , Decision Support Techniques , Health Status Indicators , Hemostasis, Surgical/statistics & numerical data , Percutaneous Coronary Intervention , Perioperative Care/methods , Postoperative Hemorrhage/prevention & control , Adult , Aged , Aged, 80 and over , Blood Loss, Surgical/statistics & numerical data , Female , Hemostasis, Surgical/methods , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/methods , Postoperative Hemorrhage/epidemiology , Prospective Studies , Risk Assessment , Treatment Outcome , United States
14.
Am Heart J ; 169(2): 234-241.e1, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25641532

ABSTRACT

BACKGROUND: While the process of informed consent is designed to transfer knowledge of the risks and benefits of treatment and to engage patients in shared medical decision-making, this is poorly done in routine clinical care. We assessed the impact of a novel informed consent form for percutaneous coronary intervention (PCI) that is more simply written, includes images of the procedure, and embeds individualized estimates of outcomes on multiple domains of successful informed consent and shared decision-making. METHODS: We interviewed 590 PCI patients receiving traditional consent documents and 527 patients receiving novel ePRISM consents at 9 US centers and compared patients' perceptions, knowledge transfer, and engagement in medical decision-making. Heterogeneity across sites was assessed and adjusted for using hierarchical models. RESULTS: Site-adjusted analyses revealed more frequent review (72% for ePRISM vs 45% for original consents) and better understanding of the ePRISM consents (ORs=1.8-3.0, depending upon the outcome) with marked heterogeneity across sites (median relative difference [MRD] in the ORs of ePRISM's effect =2-3.2). Patients receiving ePRISM consents better understood the purposes and risks of the procedure (ORs=1.9-3.9, MRDs=1.1-6.2), engaged more in shared decision-making (proportional OR=2.1 [95% CI=1.02-4.4], MRD=2.2) and discussed stent options with their physicians (58% vs. 31%; site-adjusted odds ratio=2.7 [95% CI=1.2, 6.3], MRD=2.6) more often. CONCLUSIONS: A personalized consent document improved the process of informed consent and shared decision-making. Marked heterogeneity across hospitals highlights that consent documents are but one aspect of engaging patients in understanding and participating in treatment.


Subject(s)
Coronary Disease , Decision Making , Informed Consent/standards , Patient Navigation , Percutaneous Coronary Intervention , Aged , Coronary Disease/diagnosis , Coronary Disease/psychology , Coronary Disease/therapy , Female , Humans , Information Literacy , Information Services , Male , Middle Aged , Outcome and Process Assessment, Health Care , Patient Navigation/methods , Patient Navigation/standards , Patient Participation/methods , Patient Participation/psychology , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Quality Improvement , Risk Assessment/methods , Sociometric Techniques
15.
Circulation ; 130(25): 2295-301, 2014 Dec 23.
Article in English | MEDLINE | ID: mdl-25391519

ABSTRACT

BACKGROUND: Decisions to proceed with surgical versus percutaneous revascularization for multivessel coronary artery disease are often based on subtle clinical information that may not be captured in contemporary registries. The present study sought to evaluate the association between surgical ineligibility documented in the medical record and long-term mortality among patients with unprotected left main or multivessel coronary artery disease undergoing percutaneous coronary intervention. METHODS AND RESULTS: All subjects undergoing nonemergent percutaneous coronary intervention for unprotected left main or multivessel coronary artery disease were identified at 2 academic medical centers from 2009 to 2012. Documentation of surgical ineligibility was assessed through review of electronic medical records. Cox proportional hazard models adjusted for known mortality risk factors were created to assess long-term mortality in patients with and without documentation of surgical ineligibility. Among 1013 subjects with multivessel coronary artery disease, 218 (22%) were deemed ineligible for coronary artery bypass graft surgery. The most common explicitly cited reasons for surgical ineligibility in the medical record were poor surgical targets (24%), advanced age (16%), and renal insufficiency (16%). After adjustment for known risk factors, documentation of surgical ineligibility remained independently associated with an increased risk of in-hospital (odds ratio, 6.26; 95% confidence interval, 2.16-18.15; P<0.001) and long-term mortality (hazard ratio, 2.98; 95% confidence interval, 1.88-4.72, P<0.001) after percutaneous coronary intervention. CONCLUSIONS: Documented surgical ineligibility is common and associated with significantly increased long-term mortality among patients undergoing percutaneous coronary intervention with unprotected left main or multivessel coronary disease, even after adjustment for known risk factors for adverse events during percutaneous revascularization.


Subject(s)
Coronary Artery Disease/mortality , Coronary Artery Disease/therapy , Percutaneous Coronary Intervention/mortality , Aged , Cardiac Surgical Procedures , Contraindications , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Decision Support Techniques , Female , Hospital Mortality , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Proportional Hazards Models , Risk Factors
17.
Clin Cardiol ; 37(3): 167-71, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24399781

ABSTRACT

BACKGROUND: The absence of auscultatory aortic valve closure sound is associated with severe aortic stenosis. The absence of Doppler-derived aortic opening (Aop ) or closing (Acl ) may be a sign of advanced severe aortic stenosis. HYPOTHESIS: Absent Doppler-detected Aop or Acl transient is indicative of very severe aortic stenosis and is associated with adverse outcome. METHODS: A total of 118 consecutive patients with moderate (n = 63) or severe aortic stenosis (n = 55) were included. Aop and Acl signals were identified in a blinded fashion by continuous-wave Doppler. Patients with and without Aop and Acl were compared using χ(2) test for dichotomous variables and analysis of variance for continuous variables. The associations of Aop and Acl with aortic valve replacement were determined. RESULTS: Aop or Acl were absent in 22 of 118 patients. The absence of Aop or Acl was associated with echocardiographic parameters of severe aortic stenosis. The absence of Aop or Acl was associated with incident aortic valve replacement (36.4% vs 7.3%, respectively, P < 0.001). Even in patients with aortic valve area <1 cm(2) , the absence of Aop or Acl was still associated with increased rate of aortic valve replacement (42.1% vs 13.9%, respectively, P = 0.019) and provided incremental predictive value over peak velocity. CONCLUSIONS: In a typical population of patients with aortic stenosis, approximately 1 in 6 has no detectible aortic valve opening or closing Doppler signal. The absence of an Aop or Acl signal is a highly specific sign of severe aortic stenosis and is associated with incident aortic valve replacement.


Subject(s)
Aortic Valve Stenosis/diagnostic imaging , Aortic Valve/diagnostic imaging , Echocardiography, Doppler , Heart Valve Prosthesis , Aged , Analysis of Variance , Aortic Valve/surgery , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/surgery , Blood Flow Velocity , Female , Heart Auscultation , Heart Failure/epidemiology , Humans , Male , Retrospective Studies , Severity of Illness Index
18.
J Invasive Cardiol ; 25(1): 23-7, 2013 Jan.
Article in English | MEDLINE | ID: mdl-23293171

ABSTRACT

OBJECTIVES: We aimed to assess the associations of stenting strategy and bifurcation anatomy with outcomes of percutaneous coronary intervention (PCI) for distal unprotected left main (ULM) coronary disease. BACKGROUND: There are limited and conflicting data regarding long-term outcomes associated with stenting strategies for PCI of distal ULM coronary disease. METHODS: Patients undergoing non-emergent PCI for distal ULM coronary disease comprised the study cohort. Baseline characteristics and outcomes including cardiac death, cardiac death or myocardial infarction (MI), and overall major adverse cardiac events (MACEs) were compared for patients undergoing single-vessel stenting (SVS) versus bifurcation stenting (BS). RESULTS: Seventy patients underwent treatment of distal ULM coronary disease with PCI. Drug-eluting stents (DESs) were used in 96% and 32 (46%) had BS. Patients undergoing SVS vs BS had more severe disease involving the left circumflex artery. Patients with BS were more likely to experience cardiac death and MI (hazard ratio [HR] 3.5; 95% confidence interval [CI], 1.1-11.1; P=.04) or combined MACE (HR, 4.2; 95% CI, 1.8-10.2; P=.001). After adjusting for angiographic characteristics of the bifurcation in Cox proportional hazards models, BS remained a significant predictor of MACE. CONCLUSIONS: In this unselected series of patients undergoing PCI for distal left main disease, a single-vessel stenting strategy was associated with superior long-term outcomes after accounting for angiographic characteristics of the bifurcation. Future studies need to take into account additional factors to clarify the ideal treatment strategy for distal left main disease.


Subject(s)
Angioplasty, Balloon, Coronary/methods , Coronary Artery Disease/therapy , Coronary Vessels/anatomy & histology , Stents , Aged , Aged, 80 and over , Angioplasty, Balloon, Coronary/mortality , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Coronary Vessels/diagnostic imaging , Death, Sudden, Cardiac/epidemiology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Proportional Hazards Models , Severity of Illness Index , Treatment Outcome
19.
Interv Cardiol ; 8(1): 14-18, 2013 Mar.
Article in English | MEDLINE | ID: mdl-29588745

ABSTRACT

There have been over a dozen studies in the drug-eluting stent era comparing the effectiveness of percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery for the treatment of unprotected left main disease. These studies have been both randomised and observational in nature. While both methodologies provide important insights, careful consideration of their respective strengths and limitations is imperative in generalising their findings.

20.
Article in English | MEDLINE | ID: mdl-23286168

ABSTRACT

In clinical practice, physicians often exploit previously observed patterns in coronary angiograms from similar patients to quickly assess the state of the disease in a current patient. These assessments involve visually observed features such as the distance of a junction from the root and the tortuosity of the arteries. In this paper, we show how these visual features can be automatically extracted from coronary artery images and used for finding similar coronary angiograms from a database. Testing on a large collection has shown the method finds clinically similar coronary angiograms from patients with similar clinical history.


Subject(s)
Algorithms , Coronary Angiography/methods , Coronary Artery Disease/diagnostic imaging , Pattern Recognition, Automated/methods , Radiographic Image Interpretation, Computer-Assisted/methods , Subtraction Technique , Humans , Radiographic Image Enhancement/methods , Reproducibility of Results , Sensitivity and Specificity
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