Outcomes of Participants With Diabetes in the ISCHEMIA Trials.

BACKGROUND: Among patients with diabetes and chronic coronary disease, it is unclear if invasive management improves outcomes when added to medical therapy. METHODS: The ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trials (ie, ISCHEMIA and ISCHEMIA-Chronic Kidney Disease) randomized chronic coronary disease patients to an invasive (medical therapy + angiography and revascularization if feasible) or a conservative approach (medical therapy alone with revascularization if medical therapy failed). Cohorts were combined after no trial-specific effects were observed. Diabetes was defined by history, hemoglobin A1c ≥6.5%, or use of glucose-lowering medication. The primary outcome was all-cause death or myocardial infarction (MI). Heterogeneity of effect of invasive management on death or MI was evaluated using a Bayesian approach to protect against random high or low estimates of treatment effect for patients with versus without diabetes and for diabetes subgroups of clinical (female sex and insulin use) and anatomic features (coronary artery disease severity or left ventricular function). RESULTS: Of 5900 participants with complete baseline data, the median age was 64 years (interquartile range, 57-70), 24% were female, and the median estimated glomerular filtration was 80 mL·min-1·1.73-2 (interquartile range, 64-95). Among the 2553 (43%) of participants with diabetes, the median percent hemoglobin A1c was 7% (interquartile range, 7-8), and 30% were insulin-treated. Participants with diabetes had a 49% increased hazard of death or MI (hazard ratio, 1.49 [95% CI, 1.31-1.70]; P<0.001). At median 3.1-year follow-up the adjusted event-free survival was 0.54 (95% bootstrapped CI, 0.48-0.60) and 0.66 (95% bootstrapped CI, 0.61-0.71) for patients with diabetes versus without diabetes, respectively, with a 12% (95% bootstrapped CI, 4%-20%) absolute decrease in event-free survival among participants with diabetes. Female and male patients with insulin-treated diabetes had an adjusted event-free survival of 0.52 (95% bootstrapped CI, 0.42-0.56) and 0.49 (95% bootstrapped CI, 0.42-0.56), respectively. There was no difference in death or MI between strategies for patients with diabetes versus without diabetes, or for clinical (female sex or insulin use) or anatomic features (coronary artery disease severity or left ventricular function) of patients with diabetes. CONCLUSIONS: Despite higher risk for death or MI, chronic coronary disease patients with diabetes did not derive incremental benefit from routine invasive management compared with initial medical therapy alone. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.

Infective Endocarditis Hospitalizations and Antibiotic Prophylaxis Rates Before and After the 2007 American Heart Association Guideline Revision.

BACKGROUND: In 2007, the American Heart Association recommended antibiotic prophylaxis for the prevention of infective endocarditis (IE) for only the highest-risk patients. Whether this change affected the use of antibiotic prophylaxis and the incidence of IE is unclear. METHODS: IE-related hospitalizations were identified from 2002 to 2014 among all adults and those at high and moderate risk for IE, stratified by age. Prescriptions for antibiotic prophylaxis were obtained from the Ontario Drug Benefit database for adults ≥65 years of age. Outcomes were antibiotic prophylaxis prescription rates and incidence of IE-related hospitalization. Trends in patient and pathogen characteristics were analyzed. Time series analyses were performed with segmented regression and change-point analyses. RESULTS: Prescriptions for antibiotic prophylaxis decreased substantially in the moderate-risk cohort after the guideline revision (mean quarterly prescriptions, 30 680 versus 17 954 [level change, -6,481; P=0.0004] per 1 million population) with a minimal, yet significant, decrease followed by a slow increase in the high-risk group. There were 7551 IE-related hospitalizations among 6884 adults ≥18 years of age. Among adults ≥65 years of age, the mean IE rate increased from 872 to 1385 and 229 to 283 per 1 million population at risk per quarter in the high- and moderate-risk groups, respectively. Change-point analyses indicated that this increase occurred in the second half of 2010 in adults ≥65 years of age, 3 years after the American Heart Association guideline revision. Staphylococcus aureus and streptococcal species accounted for 30.3% and 26.4% of all IE, with a decrease in streptococcal infections over time. CONCLUSIONS: Antibiotic prophylaxis decreased significantly in the moderate-risk group with minimal change in the high-risk group after the American Heart Association guideline revision in 2007. However, IE-related hospitalizations increased among both high- and moderate-risk patients 3 years after the revision. Our study provides support for the cessation of antibiotic prophylaxis in the moderate-risk population.

Balancing the risks of bleeding and stent thrombosis: a decision analytic model to compare durations of dual antiplatelet therapy after drug-eluting stents.

BACKGROUND: After coronary stent placement, whether dual antiplatelet therapy (DAPT) duration should be extended to prevent late stent thrombosis (ST) or adverse cardiovascular events is uncertain. METHODS: To define the reduction in ischemic events required to outweigh increased bleeding with longer-duration DAPT, we developed a decision-analytic Markov model comparing DAPT durations of 6, 12, and 30 months after DES. Separate models were developed for patients presenting with and without an acute coronary syndrome (ACS). We used sensitivity analyses to identify the incremental benefit of longer-duration DAPT on either ST or the composite of cardiac death, myocardial infarction, and ischemic stroke (major adverse cardiovascular and cerebrovascular events [MACCEs]) required to outweigh the increased risk of bleeding associated with longer DAPT. The outcome from each strategy was quantified in terms of quality-adjusted life years. RESULTS: In the non-ACS population, in order for 30 months of DAPT to be preferred over 12 months of therapy, DAPT would have to result in a 78% reduction in the risk of ST (relative risk [RR] 0.22, 3.1 fewer events per 1000) and only a 5% reduction in MACCE (RR 0.95, 2.2 fewer events per 1000) as compared with aspirin alone. For the ACS population, DAPT would have to result in a 44% reduction in the risk of ST (RR 0.56, 3.4 fewer events per 1000) but only a 2% reduction in MACCE (RR 0.98, 2.3 fewer events per 1000) as compared with aspirin alone, for 30 months of DAPT to be preferred for 12 months. CONCLUSIONS: Small absolute differences in the risk of ischemic events with longer DAPT would be sufficient to outweigh the known bleeding risks.

Angiographic characteristics of coronary arterial segments progressing to myocardial infarction in patients with and without chronic kidney disease.

BACKGROUND: Individuals with chronic kidney disease (CKD) have high rates of myocardial infarction (MI), but whether the nature of coronary lesions susceptible to plaque rupture is altered and whether the high rate of MI is related to a greater burden of atherosclerotic lesions in individuals with CKD is uncertain. METHODS: We used quantitative coronary angiography to assess atherosclerotic plaque location and characteristics at baseline and at the time of MI in 62 patients with and without CKD. Univariate and multivariable conditional logistic regression models were used to assess whether the association between pre-MI angiographic findings and MI differs in individuals with and without CKD. RESULTS: The risk of MI rose as the distance from the coronary ostium decreased both in patients with CKD (odds ratio per 10 mm 0.92 [95 % CI 0.87-0.99]) and in those without CKD (odds ratio 0.83 [95 % CI 0.75-0.93]). Although tighter degrees of coronary stenosis were associated with increased risks of MI in patients with and without CKD, the majority of MIs (70.9 % in patients with CKD and 89.5 % in those without CKD) occurred in segments with <50 % diameter stenosis at baseline. CONCLUSIONS: The characteristics of lesions progressing to MI are similar in individuals with and without CKD and the majority of events occur in areas with <50 % stenosis at baseline. Given the high burden of non-stenotic lesions in patients with CKD, an interventional strategy aimed solely at sites with high-grade stenosis is unlikely to markedly reduce the risk of MI in patients with CKD.

Health Status and Clinical Outcomes in Older Adults With Chronic Coronary Disease: The ISCHEMIA Trial.

BACKGROUND: Whether initial invasive management in older vs younger adults with chronic coronary disease and moderate or severe ischemia improves health status or clinical outcomes is unknown. OBJECTIVES: The goal of this study was to examine the impact of age on health status and clinical outcomes with invasive vs conservative management in the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial. METHODS: One-year angina-specific health status was assessed with the 7-item Seattle Angina Questionnaire (SAQ) (score range 0-100; higher scores indicate better health status). Cox proportional hazards models estimated the treatment effect of invasive vs conservative management as a function of age on the composite clinical outcome of cardiovascular death, myocardial infarction, or hospitalization for resuscitated cardiac arrest, unstable angina, or heart failure. RESULTS: Among 4,617 participants, 2,239 (48.5%) were aged <65 years, 1,713 (37.1%) were aged 65 to 74 years, and 665 (14.4%) were aged ≥75 years. Baseline SAQ summary scores were lower in participants aged <65 years. Fully adjusted differences in 1-year SAQ summary scores (invasive minus conservative) were 4.90 (95% CI: 3.56-6.24) at age 55 years, 3.48 (95% CI: 2.40-4.57) at age 65 years, and 2.13 (95% CI: 0.75-3.51) at age 75 years (Pinteraction = 0.008). Improvement in SAQ Angina Frequency was less dependent on age (Pinteraction = 0.08). There were no age differences between invasive vs conservative management on the composite clinical outcome (Pinteraction = 0.29). CONCLUSIONS: Older patients with chronic coronary disease and moderate or severe ischemia had consistent improvement in angina frequency but less improvement in angina-related health status with invasive management compared with younger patients. Invasive management was not associated with improved clinical outcomes in older or younger patients. (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches [ISCHEMIA]; NCT01471522).

European Registry of Carotid Artery Stenting: results from a prospective registry of eight high volume EUROPEAN institutions.

BACKGROUND: Carotid endarterectomy (CEA) is the standard revascularization therapy to prevent stroke in patients with carotid artery disease. Carotid artery stenting (CAS) could be considered a potential alternative in patients at high surgical risk. Recent clinical trials have challenged this concept due a relatively high incidence of post-CAS adverse events, which occurred in low volume centers. The aim of this study was to evaluate the outcomes associated with neuroprotected CAS in selected high volume centers. METHODS: From January 2007 to December 2007, 1,611 patients underwent neuroprotected CAS in eight European Centers. For each patients, clinical, procedural, and one month follow-up data from all patients have been collected. An independent clinical events committee adjudicated the events. RESULTS: Overall in hospital death was 0.06% (one patient), whereas in-hospital stroke was 0.49% (eight patients). Between hospital discharge and 30 days three additional patients died (0.18%) and 10 patients experienced a stroke (0.67%). Overall 30 days mortality was 0.24% (four patients) and stroke incidence 1.12% (18 patients). The 30 day stroke/death rate was 1.36%. CONCLUSIONS: CAS is a reasonable alternative to CEA to treat carotid artery atherosclerosis in well-experienced high volume centers. These data suggest that future prospective trials comparing CAS and CEA outcomes should include only centers highly experienced in both treatment modalities.

Lack of association between migraine headache and patent foramen ovale: results of a case-control study.

BACKGROUND: Clinical observations of migraine headache symptoms in patients with a patent foramen ovale (PFO), both of which conditions are highly prevalent, have raised the question of a possible pathophysiological relationship. We sought to evaluate the assumption of an association between migraine headaches and the presence of PFO by use of a large case-control study. METHODS AND RESULTS: We conducted a case-control study to assess the prevalence of PFO in subjects with and without migraine. Case subjects were those with a history of migraine (diagnosed by neurologists at a specialty academic headache clinic). Control subjects were healthy volunteers without migraine 1:1 matched on the basis of age and sex with case subjects. Presence of PFO was determined by transthoracic echocardiogram with second harmonic imaging and transcranial Doppler ultrasonography during a standardized procedure of infused agitated saline contrast with or without Valsalva maneuver and a review of the results by experts blinded to case-control status. PFO was considered present if both studies were positive. Odds ratios were calculated with conditional logistic regression in the matched cohort (n=288). In the matched analysis, the prevalence of PFO was similar in case and control subjects (26.4% versus 25.7%; odds ratio 1.04, 95% confidence interval 0.62 to 1.74, P=0.90). There was no difference in PFO prevalence in those with migraine with aura and those without (26.8% versus 26.1%; odds ratio 1.03, 95% confidence interval 0.48 to 2.21, P=0.93). CONCLUSIONS: We found no association between migraine headaches and the presence of PFO in this large case-control study.

Drug-eluting or bare-metal stents for acute myocardial infarction.

BACKGROUND: Studies comparing percutaneous coronary intervention (PCI) with drug-eluting and bare-metal coronary stents in acute myocardial infarction have been limited in size and duration. METHODS: We identified all adults undergoing PCI with stenting for acute myocardial infarction between April 1, 2003, and September 30, 2004, at any acute care, nonfederal hospital in Massachusetts with the use of a state-mandated database of PCI procedures. We performed propensity-score matching on three groups of patients: all patients with acute myocardial infarction, all those with acute myocardial infarction with ST-segment elevation, and all those with acute myocardial infarction without ST-segment elevation. Propensity-score analyses were based on clinical, procedural, hospital, and insurance information collected at the time of the index procedure. Differences in the risk of death between patients receiving drug-eluting stents and those receiving bare-metal stents were determined from vital-statistics records. RESULTS: A total of 7217 patients were treated for acute myocardial infarction (4016 with drug-eluting stents and 3201 with bare-metal stents). According to analysis of matched pairs, the 2-year, risk-adjusted mortality rates were lower for drug-eluting stents than for bare-metal stents among all patients with myocardial infarction (10.7% vs. 12.8%, P=0.02), among patients with myocardial infarction with ST-segment elevation (8.5% vs. 11.6%, P=0.008), and among patients with myocardial infarction without ST-segment elevation (12.8% vs. 15.6%, P=0.04). The 2-year, risk-adjusted rates of recurrent myocardial infarction were reduced in patients with myocardial infarction without ST-segment elevation who were treated with drug-eluting stents, and repeat revascularization rates were significantly reduced with the use of drug-eluting stents as compared with bare-metal stents in all groups. CONCLUSIONS: In patients presenting with acute myocardial infarction, treatment with drug-eluting stents is associated with decreased 2-year mortality rates and a reduction in the need for repeat revascularization procedures as compared with treatment with bare-metal stents.

Giant, thrombosed, sellar-suprasellar internal carotid artery aneurysm with persistent, primitive trigeminal artery causing hypopituitarism.

A rare case of a giant, thrombosed, sellar-suprasellar paraclinoid internal carotid artery (ICA) aneurysm with persistent primitive trigeminal artery (PPTA) causing hypopituitarism that manifested as hypogonadism, hypothyroidism, and hypocortisolism is reported. There were no visual/neurological deficits, diabetes insipidus, or episodes of subarachnoid hemorrhage. The alteration in the flow dynamics of the circle of Willis due to the presence of PPTA may have been responsible for both the genesis of the giant aneurysm as well as for the induction of thrombogenesis within its lumen. As the digital subtraction angiogram showed complete thrombosis within the aneurysm and hormonal replacement therapy was effective in ensuring complete normalization of symptoms, the patient was unwilling to undergo surgical clipping of the aneurysm and removal of the suprasellar clot in an attempt to restore pituitary functions. Hypopituitarism recurred when the patient stopped her hormonal supplementation therapy after 7 years, and she again became symptom-free on restarting the therapy. To the best of the authors' knowledge, this represents the first reported case in the literature of hypopituitarism consequent to a giant, thrombosed, sellar-suprasellar ICA aneurysm with an associated PPTA on the side of the aneurysm.

Impact of Transcatheter Mitral Valve Repair on Preprocedural and Postprocedural Hospitalization Rates.

OBJECTIVES: The objective of this study was to determine the effect of transcatheter mitral valve repair (TMVr) on hospitalization rates by assessing pre- and postprocedural hospitalization patterns. BACKGROUND: TMVr has emerged as the treatment of choice for selected patients with mitral regurgitation, but the impact of these procedures on hospital utilization remains unclear. METHODS: All patients who underwent TMVr in Ontario, Canada, between 2011 and 2017 were included in this observational study using population-based data. Hospitalization person-year rates were assessed in the years before and after TMVr and 4 predefined intervals: 1 to 30, 31 to 90, 91 to 182, and 183 to 365 days. Main outcomes of interest were all-cause and heart failure (HF) hospitalizations. Poisson regression models were used to compare incidence rates across all time periods. RESULTS: The study cohort included 523 patients. In the year preceding TMVr, 66.2% of patients were hospitalized compared with 47.4% in the year following. There were stepwise increases in both all-cause and HF hospitalization rates in the periods preceding the index procedure, and all postprocedural periods had significantly lower hospitalization rates. The adjusted rate ratios for all-cause and HF-related hospitalization in the year after TMVr were 0.65 (95% CI: 0.56-0.76) and 0.38 (95% CI: 0.29-0.51), respectively. All time periods had significant reductions in all-cause and HF hospitalization in the adjusted analysis. CONCLUSIONS: In this population-based study, significant reductions were observed in both all-cause and HF-related hospitalizations in all time periods after TMVr compared with the year prior. This suggests that TMVr has a sustained effect on hospitalization rates despite a high-risk population.

Short Durations of Radial Hemostatic Device After Diagnostic Transradial Cardiac Catheterization: The PRACTICAL-2 Randomized Trial.

BACKGROUND: Radial artery occlusion (RAO) is the most common complication following transradial approach (TRA) for cardiac catheterisation. Our aim was to assess if decreasing radial hemostatic device (RHD) time reduces the risk of RAO among individuals receiving small sheath sizes with no adjunctive heparin. METHODS: We randomised 450 individuals undergoing diagnostic cardiac catheterization via TRA to 3 durations of RHD time: 10, 20, or 30 minutes. After these time periods, the RHD was gradually released over 20 minutes. The primary efficacy end point was forearm hematoma grade ≥ 2 (5-10 cm) and the primary safety end point was RAO (as determined by Doppler ultrasound) 1 hour after RHD removal (before discharge). RESULTS: The mean age was 66 years and 64% were male. Five-French sheaths were used in all patients. Hematoma grade ≥ 2 occurred in only 1 patient, who was in the 20-minute group (P = 0.39). RAO occurred in 6.7% of patients in the 10-minute group, 10.7% in the 20-minute group and 6% in the 30-minute group (P = 0.26). CONCLUSIONS: Among patients receiving small-caliber sheaths without adjunctive heparin, the incidence of forearm hematoma and RAO are low. Shorter durations of RHD time did not further reduce the risk of these complications.

The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation.

BACKGROUND: Mitral valve surgery is the standard of care for patients with symptomatic mitral regurgitation (MR) or asymptomatic MR with evidence of left ventricular dysfunction or dilation. Whether an endovascular approach to repair can offer comparable effectiveness with improved safety remains to be determined in randomized trials. STUDY DESIGN: The EVEREST II Trial is a multicenter, randomized controlled trial to evaluate the benefits and risks of endovascular mitral valve repair using the MitraClip device compared with open mitral valve surgery (control) in patients with moderate or severe MR. Using a 2:1 randomization ratio, the trial is enrolling up to 186 MitraClip-treated subjects and 93 control subjects. Trial end points include a primary efficacy end point: the proportion of patients free from death, surgery for valve dysfunction, and with moderate-severe (3+) or severe (4+) MR at 12 months; the primary safety end point includes the proportion of patients with death, myocardial infarction, reoperation, nonelective cardiovascular surgery, stroke, renal failure, deep would infection, ventilation >48 hours, gastrointestinal complication, new permanent atrial fibrillation, septicemia, or transfusion of >or=2 U at 30 days or hospital discharge, whichever is longer. CONCLUSIONS: This randomized controlled trial is designed to evaluate the performance of endovascular mitral repair in comparison to open mitral valve surgery in patients with significant MR.

Management of multiple tethering in spinal dysraphism.

INTRODUCTION: The most challenging component of spinal dysraphism is cord tethering. Tethering can occur due to single or multiple lesions within the same patient. It is imperative to aggressively identify and release all the tethering lesions in order to provide maximum benefit to the patient. With increasing number of tethering lesions, the clinical profile and outcome show significant differences, and this difference is significantly more when more than two tethering lesions coexist in the same patient. MATERIAL AND METHODS: Out of the 248 patients of spinal dysraphism who underwent surgical management at Sanjay Gandhi Institute of Medical Sciences, Lucknow, India, between 1997 and 2007, 160 were included in the study. Patients were classified into two groups based on the number of tethering lesions. The first group (Group A) comprised cases of spinal dysraphism with tethering demonstrable at one or two sites. The second group (Group B) comprised patients with radiological or intraoperative evidence of multiple tethering lesions (more than two). RESULTS: There were 119/160 patients in Group A, while 41/160 patients were in Group B (with more than two sites of tethering). The preoperative neurological examination revealed significant differences between the two study groups. The clinical profile and the surgical outcomes have shown significant differences in the two study groups. These differences are statistically significant. CONCLUSION: We strongly believe that the mere presence or absence of tethering is not a sufficient documentation to predict its effect on the cases of spinal dysraphism. Tethering is a complex entity that needs to be further classified in terms of the number of tethering lesions, which significantly affect the pre- and postoperative status of the patients. We would like to suggest the term "Spina Bifida Multiplex" for the cases where more than two lesions are found to be responsible for tethering.

Morbidity in Pregnant Women with a Prosthetic Heart Valve.

BACKGROUND: Women with a prosthetic heart valve are perceived to be at higher risk for adverse outcomes, but their absolute and relative risk of experiencing maternal morbidity and cardiac complications is largely unknown. OBJECTIVE: The objective of the study was to determine the risk of maternal morbidity and cardiac complications in women with a prior heart valve replacement, compared with matched counterparts without known cardiac disease. STUDY DESIGN: A retrospective population-based matched cohort study was completed in the province of Ontario, Canada, where there is universal health care. Included were all women of child-bearing age who had bioprosthetic or mechanical replacement of the mitral or aortic valve, April 1994 to March 2016 (valve replacement group). Those in the valve replacement group, and who had at least 1 birth, were 1:4 matched to a community comparison group without heart disease and who also had at least 1 birth. Matching was by maternal age at cohort entry, year of cohort entry, geographic area, income level, and age at first birth. Maternal outcomes included severe maternal morbidity, all-cause mortality, and cardiac morbidity as well as a prolonged hospital length of stay >7 days. Relative risks and 95% confidence intervals were further adjusted for age at birth and immigration status. RESULTS: There were 90 live births among the 64 women in the valve replacement group and 404 live births among the 253 women in the matched community comparison group. There were no stillbirths. Severe maternal morbidity occurred in 13 pregnancies (14.4%) in the valve replacement group and 6 (1.5%) in the community comparison group (adjusted relative risk, 9.73, 95% confidence interval, 3.70-25.59); there were no maternal deaths. The corresponding rates of prolonged hospital length of stay were 37.8% and 18.8% (adjusted relative risk, 2.33, 95% confidence interval, 1.48-3.67). CONCLUSION: Pregnant women who had aortic or mitral valve replacement were more likely to experience severe maternal morbidity, as well as prolonged hospital length of stay, than matched counterparts without heart disease. This information can enhance shared decision making about the timing of valve replacement and pregnancy planning in young and middle-aged women. To determine the absolute and relative risk of maternal morbidity and cardiac complications in women with prior heart valve replacement, a retrospective population-based matched cohort study was completed in the province of Ontario, Canada, where there is universal health care. Included were all women of child-bearing age who had bioprosthetic or mechanical replacement of the mitral or aortic valve, April 1994 to March 2016 (valve replacement group). Those in the valve replacement group, and who had at least one birth, were 1:4 matched to a community comparison group without heart disease and who also had at least 1 birth. There were 90 live births among the 64 women in the valve replacement group and 404 live births among the 253 women in the matched community comparison group. Severe maternal morbidity occurred in 13 pregnancies (14.4%) in the valve replacement group and 6 (1.5%) in the community comparison group (adjusted relative risk, 9.73); there were no maternal deaths. The corresponding rates of prolonged hospital length of stay were 37.8% and 18.8% (adjusted relative risk, 2.33). In summary, pregnant women who had an aortic or mitral valve replacement were more likely to experience severe maternal morbidity, as well as prolonged hospital length of stay, than matched counterparts without heart disease.

Drug-eluting or bare-metal stenting in patients with diabetes mellitus: results from the Massachusetts Data Analysis Center Registry.

BACKGROUND: Patients with diabetes mellitus (DM) are at high risk for restenosis, myocardial infarction, and cardiac mortality after coronary stenting, and the long-term safety of drug-eluting stents (DES) relative to bare-metal stents (BMS) in DM is uncertain. We report on a large consecutive series of patients with DM followed up for 3 years after DES and BMS from a regional contemporary US practice with mandatory reporting. METHODS AND RESULTS: All adults with DM undergoing percutaneous coronary intervention with stenting between April 1, 2003, and September 30, 2004, at all acute care nonfederal hospitals in Massachusetts were identified from a mandatory state database. According to index admission stent type, patients were classified as DES treated if all stents were drug eluting and as BMS treated if all stents were bare metal; patients treated with both types of stents were excluded from the primary analysis. Mortality rates were obtained from vital statistics records, and myocardial infarction and revascularization rates were obtained from the state database with complete 3 years of follow-up on the entire cohort. Risk-adjusted mortality, myocardial infarction, and revascularization differences (DES-BMS) were estimated with propensity-score matching based on clinical, procedural, hospital, and insurance information collected at the index admission. DM was present in 5051 patients (29% of the population) treated with DES or BMS during the study. Patients with DM were more likely to receive DES than BMS (66.1% versus 33.9%; P<0.001). The unadjusted cumulative incidence of mortality at 3 years was 14.4% in DES versus 22.2% in BMS (P<0.001). Based on propensity-score analysis of 1:1 matched DES versus BMS patients (1476 DES:1476 BMS), the risk-adjusted mortality, MI, and target vessel revascularization rates at 3 years were 17.5% versus 20.7% (risk difference, -3.2%; 95% confidence interval, -6.0 to -0.4; P=0.02), 13.8% versus 16.9% (-3.0%; 95% confidence interval, -5.6 to 0.5; P=0.02), and 18.4% versus 23.7% (-5.4%; confidence interval, -8.3 to -2.4; P<0.001), respectively. CONCLUSIONS: In a real-world diabetic patient population with mandatory reporting and follow-up, DES were associated with reduced mortality, myocardial infarction, and revascularization rates at long-term follow-up compared with BMS.

Cost-effectiveness analysis of short-duration dual antiplatelet therapy with newer drug-eluting stent platforms versus longer-duration dual antiplatelet therapy with a second-generation drug-eluting stent in elective percutaneous coronary intervention.

BACKGROUND: The cost-effectiveness of newer drug-eluting stents (DES) such as biodegradable-polymer or polymer-free stents with shorter dual antiplatelet therapy (DAPT) duration is unknown. We evaluated the cost-effectiveness of treatment with newer DES that may allow for shorter DAPT duration. PATIENTS AND METHODS: We performed a cost-effectiveness analysis of treatment with newer DES platforms followed by 1 or 3 months of DAPT compared with standard second-generation DES followed by 6 or 12 months of DAPT in patients with stable coronary disease. A Markov model simulated distinct health states over a lifetime. Probabilistic sensitivity analysis and one-way sensitivity analyses were performed. A high-risk bleeding scenario was also evaluated. RESULTS: Among patients with typical bleeding risk, second-generation DES and 6 months of DAPT was less expensive and resulted in marginally higher quality-adjusted life years compared with other strategies. A newer DES platform and 3 months of DAPT was preferred when the risk of fatal bleeding was two times greater than baseline, or when bleeding increased long-term mortality by a factor of 1.5. In a probabilistic sensitivity analysis, second-generation DES and 6 months of DAPT was preferred in 58% of iterations, whereas in a high-risk bleeding patient scenario, a newer DES and 3 months of DAPT was preferred in 52% of iterations. CONCLUSION: A DES that allows 3 months of DAPT without increasing stent-related events is likely to be cost-effective among patients at elevated risk of bleeding, but not in patients with average bleeding risk.

Attained pregnancy among women with a prosthetic heart valve.

BACKGROUND: Women with prosthetic heart valves are at higher risk for adverse outcomes during pregnancy. The rates of achieved pregnancy, regardless of the pregnancy outcome, are largely unknown in this group of women. OBJECTIVE: To determine the rate of pregnancy in women with prior heart valve replacement, and compare that to women without known heart disease. STUDY DESIGN: A retrospective matched population-based cohort study was done between April 1994 and March 2017, in Ontario, Canada, where universal health care is available. Administrative healthcare databases were used to identify study participants, exposures and outcomes. Each woman of child-bearing age who had a bioprosthetic or mechanical mitral or aortic valve replacement (valve replacement group) was matched to four women without heart disease (community comparison group) -- by age, year of cohort entry, any recent prior pregnancy, geographic area of residence and income level. Starting after the date of cohort entry (defined as the date valve replacement date in the valve replacement group), participants were assessed for a recognized pregnancy, namely, a livebirth, stillbirth, miscarriage or induced abortion. Hazard ratios (HR) and 95% confidence intervals (CI) were further adjusted for age, immigrant status and comorbid medical conditions. RESULTS: 1596 women with a valve replacement were matched with 6378 women in the community comparison group. After a median (interquartile range, IQR) duration of follow-up of 3.1 (1.0-5.6) and 2.7 (1.0-6.0) years, respectively, 98 women in the valve replacement group achieved a recognized pregnancy (0.63 per 100 person-years), compared to 607 women in the community comparison group (0.88 per 100 person-years) - an adjusted HR of 0.72 (95% CI 0.57-0.89). Within the valve replacement group, those with a mechanical valve were less likely to achieve a recognized pregnancy than those with a bioprosthetic valve (adjusted HR 0.57, 95% CI 0.38-0.87). CONCLUSION: Women who undergo aortic or mitral valve replacement are less likely to achieve a pregnancy than matched counterparts without heart disease. This information, and the reasons for why this is so, can inform decisions about the timing of valve replacement and pregnancy planning.

Same-Day Discharge After Elective Percutaneous Coronary Interventions in Ontario, Canada.

Background To manage overcrowding and bed shortages in Canadian hospitals, same-day discharge (SDD) after percutaneous coronary intervention (PCI) has emerged as a solution to improve resource utilization. However, limited information exists regarding current trends, hospital variation, and safety of SDD PCI in Canada. Methods and Results We evaluated outpatients undergoing elective PCI in Ontario, Canada, from October 2008 to March 2016. SDD was defined when patients were discharged on the day of PCI, and non-SDD was defined as those patients who had 1 overnight stay. The primary outcome was 30-day all-cause death or hospitalization for acute coronary syndrome. Inverse probability of treatment weighting with propensity score was used to account for differences in baseline and clinical characteristics between SDD and non-SDD groups. Among 35 972 patients who underwent elective PCI at 17 PCI centers in Ontario, 10 801 patients (30%) had SDD PCI and 25 121 patients (70%) had non-SDD PCI. Substantial hospital variation for SDD PCI was observed, ranging from 0% to 87% during the study period. In the propensity-weighted cohort, SDD patients had no significant difference in 30-day rates of death or hospitalization for acute coronary syndrome (1.3% versus 1.6%; hazard ratio: 0.84 [95% CI, 0.65-1.08]; P=0.17) compared with non-SDD patients. SDD and non-SDD patients also had no significant difference in 30-day rates of mortality or coronary revascularization. Conclusions In this large population-based cohort of elective PCI patients, we demonstrated the safety of SDD PCI. Increased adoption of this strategy could lead to improved bed-flow efficiency and substantial savings for the Canadian healthcare system without comprising outcomes.

The new world of cardiac interventions: a brief review of the recent advances in non-coronary percutaneous interventions.

Advances in cardiovascular interventional techniques have allowed percutaneous treatment of conditions that either previously required open operations or have not been amenable to treatment. Conditions such as atrial and ventricular septal defects and patent foramen ovale are now amenable to percutaneous closure using implantable devices. A number of strategies have evolved to reduce the risk of stroke such as percutaneous occlusion of the left atrial appendage for patients in atrial fibrillation. Valvular heart disease and complications of its repair are approachable via the percutaneous route. Percutaneous pulmonary and aortic valve replacements have been performed in humans. There are evolving techniques for repair of the mitral valve and of prosthetic paravalvular leaks using devices such as the Amplatzer septal occluder to repair the defects without the need for repeat open heart surgery. Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction can now be approached using alcohol septal ablation with results comparable to the surgical technique. These advances have occurred as a result of improvement in the design of the devices used as well as a better understanding of the pathophysiology of conditions. Many of these techniques are in evolution and in this paper we review some of the recent developments in this dynamic area of interventional cardiology.