Sacral neuromodulation versus onabotulinumtoxinA for refractory urgency urinary incontinence: impact on fecal incontinence symptoms and sexual function.

BACKGROUND: Women with refractory urgency urinary incontinence can be treated with onabotulinumtoxinA or sacral neuromodulation. Little data exists on the comparative effects of treatment of refractory urgency urinary incontinence on other pelvic floor complaints, such as bowel and sexual function. OBJECTIVE: The objective of this study was to compare the impact of these treatments on fecal incontinence and sexual symptoms. METHODS: This was a planned supplemental analysis of a randomized trial in women with refractory urgency urinary incontinence treated with onabotulinumtoxinA (n = 190) or sacral neuromodulation (n = 174). Fecal incontinence and sexual symptoms were assessed at baseline and at 6, 12, and 24 months. Fecal incontinence symptoms were measured using the St Mark's (Vaizey) Fecal Incontinence severity scale. Sexual symptoms were measured using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) and the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). The PISQ-IR allows measurement of sexual symptoms in both sexually active and non-sexually active adults. Primary outcomes were change in Vaizey and PISQ-12 scores between baseline and 6 months. Secondary outcomes were change in PISQ-IR total and subscores between baseline and 6 months and change in Vaizey, PISQ-12, and PISQ-IR scores between baseline and 12 and 24 months. Intent-to-treat analysis was performed using repeated measures mixed model to estimate change in all parameters from baseline while adjusting for the baseline score. A subgroup analysis of women with clinically significant bowel symptoms was conducted based on baseline Vaizey score of ≥12. RESULTS: At baseline, mean Vaizey scores were indicative of mild fecal incontinence symptoms and were not different between onabotulinumtoxinA and sacral neuromodulation groups (7.6 ± 5.3 vs 6.6 ± 4.9, P = .07). The proportion of sexually active women (56% vs 63%, P = .25), mean PISQ-12 score (33.4 ± 7.5 vs 32.7 ± 6.7, P = .55), or PISQ-IR subscores were also not different between the onabotulinumtoxinA and sacral neuromodulation groups at baseline. There was no difference between women treated with onabotulinumtoxinA and those treated with sacral neuromodulation at 6 months in terms of improvement in fecal incontinence symptom score (Vaizey: -1.9, 95% confidence interval -2.6 to -1.2 vs -0.9, 95% confidence interval -1.7 to -0.2, P = .07) or sexual symptoms score (PISQ-12: 2.2, 95% confidence interval 0.7 to 3.7 vs 2.2, 95% confidence interval 0.7 to 3.7, P = .99). There was no difference in improvement between groups in the sexual symptom subscores in sexually active and non-sexually active women at 6 months. Similar findings were noted at 12 and 24 months. In a subgroup (onabotulinumtoxinA = 33 and sacral neuromodulation = 22) with clinically significant fecal incontinence at baseline (Vaizey score ≥12), there was a clinically meaningful improvement in symptoms in both groups from baseline to 6 months, with no difference in improvement between the onabotulinumtoxinA and sacral neuromodulation groups (-5.1, 95% confidence interval -7.3 to -2.8 vs -5.6, 95% confidence interval -8.5 to -2.6, P = .8). CONCLUSION: There were no differences in improvement of fecal incontinence and sexual symptoms in women with urgency urinary incontinence treated with onabotulinumtoxinA or sacral neuromodulation. Women with significant fecal incontinence symptoms at baseline had clinically important improvement in symptoms, with no difference between the treatments. Our findings can help clinicians counseling women considering treatment for refractory urgency urinary incontinence.

Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial.

BACKGROUND: Urgency urinary incontinence (UUI) is a chronic condition for which sacral neuromodulation (SNM) (InterStim/Medtronic) and onabotulinumtoxinA (BTX) (BotoxA/Allergan) are utilized. These therapies have not been compared over extended time. OBJECTIVE: To compare UUI episodes (UUIE) over 24 mo following SNM or BTX. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, open-label, randomized, extension trial (February 2012-July 2016) at nine US medical centers involving 386 women with ≥6 UUIE over 3 d inadequately managed by medications. Participants were clinical responders to treatment: ≥50% reduction in UUIEs after SNM placement or 1 mo post BTX. INTERVENTION: SNM (n=194) versus 200 U BTX (n=192). SNM reprogrammings occurred throughout the 24 mo. After 6 mo, two additional BTX injections were allowed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcome: change in mean daily UUIE over 24 mo. SECONDARY OUTCOMES: no UUIE, ≥75% and ≥50% UUIE reduction; Overactive Bladder Questionnaire Short Form; Urinary Distress Inventory short form; Incontinence Impact Questionnaire; Patient Global Impression of Improvement; Overactive Bladder Satisfaction of Treatment Questionnaire; and adverse events (AEs). Primary analysis used a linear mixed model. RESULTS AND LIMITATIONS: Outcome data were available for 260/298 (87%) clinical responders. No difference in decreased mean UUIE was found over 24 mo (-3.88 vs -3.50 episodes/d,95% confidence interval [CI]=-0.14-0.89; p=0.15), with no differences in UUI resolution, ≥75% or ≥50% UUIE reduction. BTX group maintained higher satisfaction (mean difference=-9.14, 95% CI=-14.38--3.90; p<0.001), treatment endorsement (mean difference=-12.16, 95% CI=-17.7--6.63; p<0.001) through 24 mo. Other secondary measures did not differ. Recurrent urinary tract infections (UTIs) were higher after BTX (24% vs 10%; p<0.01), 6% required intermittent catheterization post second injection. SNM revision and removals occurred in 3% and 9% patients, respectively. CONCLUSIONS: Both treatments offered sustainable UUI improvement, and higher BTX dosing had low clean intermittent catheterization rates, but with UTI risk. SNM revision/removal rates were low due to standardized lead placement with strict treatment response definitions. PATIENT SUMMARY: We compared a large group of US women with severe urgency urinary incontinence (UUI) who received sacral neuromodulation (InterStim) or onabotulinumtoxinA (Botox A) therapy during a 2-yr period. We found that both therapies had similar success in reducing UUI symptoms, and adverse events were low. However, women in the BotoxA group had higher satisfaction and endorsement with their treatment, but with a higher chance of a urinary tract infection. We conclude that both therapies offer sustained reduction in daily incontinence over 2 yr.

Persistence with secondary prevention medications after acute myocardial infarction: Insights from the TRANSLATE-ACS study.

BACKGROUND: Persistent use of secondary prevention therapies after acute myocardial infarction (MI) is critical to optimizing long-term outcomes. METHODS: Medication persistence was assessed among 7,955 MI patients in 216 hospitals participating in the Treatment with Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome study from 2010 to 2012. Persistence was defined as continuation of aspirin, adenosine diphosphate receptor inhibitors, ß-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and statins from discharge to 6 months post-MI. Multivariable logistic regression modeling was used to determine factors associated with nonpersistence, defined as <80% persistence with all medication classes. RESULTS: Overall, 31% of MI patients stopped taking a least 1 medication by 6 months. The most common reasons cited for medications discontinuation were side effects and physician instruction (57%), whereas financial concerns were cited in 8% overall. After multivariable modeling, black race (odds ratio 1.36, 95% CI 1.15-1.62), older age (odds ratio 1.07, 95% CI 1.02-1.12), atrial fibrillation (odds ratio 1.67, 95% CI 1.33-2.09), dialysis (odds ratio 1.79, 95% CI 1.15-2.78), and depression (odds ratio 1.22, 95% CI 1.02-1.45) were associated with lower likelihood of persistence. Private insurance (odds ratio 0.85, 95% 0.76-0.95), prescription cost assistance (odds ratio 0.63, 95% CI 0.54-0.75), and outpatient follow-up arranged before discharge (odds ratio 0.89, 95% CI 0.80-0.99) were associated with higher persistence. CONCLUSIONS: Nearly one-third of MI patients are no longer persistent with their prescribed medications by 6 months. Patients at high risk for nonpersistence may be identified by clinical and sociodemographic features. These observations underscore key opportunities to optimize longitudinal use of secondary prevention therapies.

Early Medication Nonadherence After Acute Myocardial Infarction: Insights into Actionable Opportunities From the TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) Study.

BACKGROUND: Nonadherence to prescribed evidence-based medications after acute myocardial infarction (MI) can contribute to worse outcomes and higher costs. We sought to better understand the modifiable factors contributing to early nonadherence of evidence-based medications after acute MI. METHODS AND RESULTS: We assessed 7425 acute MI patients treated with percutaneous coronary intervention at 216 US hospitals participating in TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) between April 2010 and May 2012. Using the validated Morisky instrument to assess cardiovascular medication adherence at 6 weeks post MI, we stratified patients into self-reported high (score, 8), moderate (score, 6-7), and low (score, <6) adherence groups. Moderate and low adherence was reported in 25% and 4% of patients, respectively. One third of low adherence patients described missing doses of antiplatelet therapy at least twice a week after percutaneous coronary intervention. Signs of depression and patient-reported financial hardship because of medication expenses were independently associated with a higher likelihood of medication nonadherence. Patients were more likely to be adherent at 6 weeks if they had follow-up appointments made before discharge and had a provider explain potential side effects of their medications. Lower medication adherence may be associated with a higher risk of 3-month death/readmission (adjusted hazard ratio, 1.35; 95% confidence interval, 0.98-1.87) although this did not reach statistical significance. CONCLUSIONS: Even early after MI, a substantial proportion of patients report suboptimal adherence to prescribed medications. Tailored patient education and pre discharge planning may represent actionable opportunities to optimize patient adherence and clinical outcomes. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01088503.

Cluster-randomized clinical trial examining the impact of platelet function testing on practice: the treatment with adenosine diphosphate receptor inhibitors: longitudinal assessment of treatment patterns and events after acute coronary syndrome prospective open label antiplatelet therapy study.

BACKGROUND: Little is known about how clinicians use platelet function testing to guide choice and dosing of adenosine diphosphate receptor inhibitor (ADPri) therapy in routine community practice. METHODS AND RESULTS: The Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (ACS)-Prospective, Open Label, Antiplatelet Therapy Study (TRANSLATE-POPS) was a cluster-randomized trial in which 100 hospitals were assigned access to no-cost platelet function testing versus usual care for acute myocardial infarction patients treated with percutaneous coronary intervention. In both arms, ADPri treatment decisions were left up to the care team. The primary end point was the frequency of ADPri therapy adjustment before discharge. Secondary end points included 30-day rates of major adverse cardiovascular events and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries-defined bleeding events. Platelet function testing was performed in 66.9% of patients treated in intervention sites versus 1.4% of patients in usual care sites. Intervention arm patients were more likely to have ADPri therapy adjustment than usual care patients (14.8% versus 10.5%, P=0.004; odds ratio 1.68, 95% confidence interval 1.18-2.40); however, there were no significant differences in 30-day major adverse cardiovascular events (4.8% versus 5.4%, P=0.73; odds ratio 0.94, 95% confidence interval 0.66-1.34) or bleeding (4.3% versus 4.2%, P=0.33; odds ratio 0.86, 95% confidence interval 0.55-1.34). One-year outcomes were also not significantly different between groups. An as-treated analysis showed higher incidence of ADPri therapy adjustment among intervention arm patients who received platelet function testing than untested usual care arm (16.4% versus 10.2%, P<0.0001), but no significant differences in major adverse cardiovascular events or bleeding. CONCLUSIONS: TRANSLATE-POPS found that when clinicians routinely used platelet function testing, they were more likely to adjust their choice or dosing of ADPri therapy; yet with few changes in therapy overall, significant differences in clinical outcomes were not seen. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01088503.

In-hospital switching between adenosine diphosphate receptor inhibitors in patients with acute myocardial infarction treated with percutaneous coronary intervention: Insights into contemporary practice from the TRANSLATE-ACS study.

AIMS: While randomized clinical trials have compared clopidogrel with higher potency adenosine diphosphate (ADP) receptor inhibitors among patients with acute myocardial infarction, little is known about the frequency, effectiveness and safety of switching between ADP receptor inhibitors in routine clinical practice. METHODS AND RESULTS: We studied 11,999 myocardial infarction patients treated with percutaneous coronary intervention at 230 hospitals from April 2010 to October 2012 in the TRANSLATE-ACS study. Multivariable Cox regression was used to compare six-month post-discharge risks of major adverse cardiovascular events (MACE: death, myocardial infarction, stroke, or unplanned revascularization) and Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO)-defined bleeding between in-hospital ADP receptor inhibitor switching versus continuation of the initially selected therapy. Among 8715 patients treated initially with clopidogrel, 994 (11.4%) were switched to prasugrel or ticagrelor; switching occurred primarily after percutaneous coronary intervention (60.9%) and at the time of hospital discharge (26.7%). Among 3284 patients treated initially with prasugrel or ticagrelor, 448 (13.6%) were switched to clopidogrel; 48.2% of switches occurred after percutaneous coronary intervention and 48.0% at hospital discharge. Switching to prasugrel or ticagrelor was not associated with increased bleeding when compared with continuation on clopidogrel (2.7% vs. 3.3%, adjusted hazard ratio 0.96, 95% confidence interval 0.64-1.42, p=0.82). Switching from prasugrel or ticagrelor to clopidogrel was not associated with increased MACE (8.9% vs. 7.7%, adjusted hazard ratio 1.06, 95% confidence interval 0.75-1.49, p=0.76) when compared with continuation on the higher potency agent. CONCLUSIONS: In-hospital ADP receptor inhibitor switching occurs in more than one in 10 myocardial infarction patients in contemporary practice. In this observational study, ADP receptor inhibitor switching does not appear to be significantly associated with increased hazard of MACE or bleeding.

Surgical revascularization is associated with maximal survival in patients with ischemic mitral regurgitation: a 20-year experience.

BACKGROUND: The optimal treatment for ischemic mitral regurgitation remains actively debated. Our objective was to evaluate the relationship between ischemic mitral regurgitation treatment strategy and survival. METHODS AND RESULTS: We retrospectively reviewed patients at our institution diagnosed with significant coronary artery disease and moderate or severe ischemic mitral regurgitation from 1990 to 2009, categorized by medical treatment alone, percutaneous coronary intervention, coronary artery bypass grafting (CABG), or CABG plus mitral valve repair or replacement. Kaplan-Meier methods and multivariable Cox proportional hazards analyses were performed to assess the relationship between treatment strategy and survival, with the use of propensity scores to account for nonrandom treatment assignment. A total of 4989 patients were included: medical treatment alone=36%, percutaneous coronary intervention=26%, CABG=33%, and CABG plus mitral valve repair or replacement=5%. Median follow-up was 5.37 years. Compared with medical treatment alone, significantly lower mortality was observed in patients treated with percutaneous coronary intervention (adjusted hazard ratio, 0.83; 95% confidence interval, 0.76-0.92; P=0.0002), CABG (adjusted hazard ratio, 0.56; 95% confidence interval, 0.51-0.62; P<0.0001), and CABG plus mitral valve repair or replacement (adjusted hazard ratio, 0.69; 95% confidence interval, 0.57-0.82; P<0.0001). There was no significant difference in these results based on mitral regurgitation severity. CONCLUSIONS: Patients with significant coronary artery disease and moderate or severe ischemic mitral regurgitation undergoing CABG alone demonstrated the lowest risk of death. CABG with or without mitral valve surgery was associated with lower mortality than either percutaneous coronary intervention or medical treatment alone.

Association of systemic lupus erythematosus with angiographically defined coronary artery disease: a retrospective cohort study.

OBJECTIVE: To determine if systemic lupus erythematosus (SLE) is associated with a higher prevalence of coronary artery disease (CAD) in select patients undergoing coronary angiography. We compared the extent of angiographic abnormalities, CAD risk factors, and all-cause mortality in SLE patients with non-SLE controls. METHODS: We identified SLE patients (n = 86) and controls matched by sex and year of cardiac catheterization (n = 258) undergoing cardiac catheterization for the evaluation of CAD (median followup duration of 4.3 years). Multivariable logistic regression was used to determine if SLE was associated with obstructive CAD, defined as ≥70% stenosis in a major epicardial coronary artery. Risk-adjusted survival differences between the 2 groups were assessed using Cox proportional hazards modeling. RESULTS: The SLE patients (85% women) were younger than the non-SLE patients (median age 49 years versus 70 years; P < 0.001) and were less likely to have diabetes mellitus and hyperlipidemia, but had similar rates of hypertension (70% versus 71%; P = 0.892). In unadjusted analyses, SLE and non-SLE patients had similar rates of obstructive CAD by angiography (52% versus 62%; overall P = 0.11). After adjustment for known CAD risk factors, SLE was associated with a significantly increased likelihood of CAD (odds ratio 2.24 [95% confidence interval (95% CI) 1.08-4.67]). SLE was also associated with a nonsignificant increase in all-cause mortality (hazard ratio 1.683 [95% CI 0.98-2.89], P = 0.060). CONCLUSION: In this selected population, SLE was significantly associated with the presence of CAD as defined by coronary angiography, the gold standard for assessing flow-limiting lesions in this disease. The patients with SLE showed a similar severity of CAD as the controls despite having less than half the rate of diabetes mellitus and being 20 years younger.

Left and codominant coronary artery circulations are associated with higher in-hospital mortality among patients undergoing percutaneous coronary intervention for acute coronary syndromes: report From the National Cardiovascular Database Cath Percutaneous Coronary Intervention (CathPCI) Registry.

BACKGROUND: Left or codominant coronary arterial circulation may represent less well-balanced myocardial perfusion and thus confer worse prognosis in acute coronary syndrome, especially for culprit lesions arising from the left coronary artery. METHODS AND RESULTS: We related left and codominance, relative to right dominance, with in-hospital mortality in 207 926 percutaneous coronary interventions (PCI) for acute coronary syndromes from July 1, 2009 through June 30, 2010 in the National Cardiovascular Data Registry Cath Percutaneous Coronary Intervention (CathPCI) Registry database version 4. Generalized estimating equations and logistic regression analyses were used in unadjusted and multivariable adjusted models. Models were adjusted using the validated National Cardiovascular Data Registry mortality risk model. We performed subgroup analyses and formally tested for effect modification by the epicardial coronary artery containing the culprit lesion. Left coronary dominance was associated with higher in-hospital mortality in unadjusted (odds ratio=1.29, 95% confidence interval [CI], 1.17-1.42) and adjusted models (1.19, 95% CI, 1.06-1.34). Codominance was associated with worsened mortality only in adjusted models (odds ratio=1.16, 95% CI, 1.01-1.34). Addition of coronary dominance to the National Cardiovascular Data Registry risk model did not materially change model discrimination or calibration. The odds of death for left versus right dominance among those with left circumflex or left main culprit lesions was 1.25 (95% CI, 1.02-1.53), for right coronary artery lesions was 1.19 (95% CI, 0.83-1.71), and for left anterior descending artery lesions was 1.09 (95% CI, 0.93-1.28). There was no statistical evidence for effect modification by culprit lesion vessel (P=0.8). CONCLUSIONS: Left and codominance are associated with modestly increased post-percutaneous coronary intervention in-hospital mortality in patients with acute coronary syndrome. Confirmation of these findings with angiographic core laboratory verification of coronary dominance and longer term follow-up will be desirable.

Incidence of thrombocytopenia among patients receiving heparin venous thromboembolism prophylaxis.

BACKGROUND: Heparin is commonly used for venous thromboembolism prophylaxis; however, the incidence of acquired thrombocytopenia in this setting has not been well described. METHODS: The Complications After Thrombocytopenia Caused by Heparin (CATCH) Registry was designed to evaluate the risk of thrombocytopenia among patients receiving heparin in diverse clinical settings. We examined the incidence, management, and outcomes of thrombocytopenia (platelet count decrease ≥50% or to nadir <150×10(9)/L) among patients with normal admission platelet counts (≥150×10(9)/L) who received ≥72 hours of heparin venous thromboembolism prophylaxis. RESULTS: Among 1017 patients receiving heparin venous thromboembolism prophylaxis, 190 (19%) developed thrombocytopenia. Factors significantly associated with the development of thrombocytopenia include higher admission platelet count, ventilator use, prolonged heparin exposure, unfractionated heparin use, lower admission blood pressure, and cardiac surgery. For thrombocytopenic patients, only 5% received serologic testing for heparin-induced thrombocytopenia, and a hematology consult was obtained in 3%, but none were switched to a direct thrombin inhibitor. Acquired thrombocytopenia was not associated with increased in-hospital risk of mortality or thromboembolic events (adjusted odds ratio 1.06; 95% confidence interval, 0.57-1.95); however, it was associated with increased Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) moderate or severe bleeding risk (adjusted odds ratio 4.49; 95% confidence interval, 2.24-9.02). CONCLUSION: Thrombocytopenia occurs frequently in patients on heparin venous thromboembolism prophylaxis, yet its diagnosis has minimal impact on downstream management. The development of thrombocytopenia is associated with increased bleeding risk.

Relationship of the time interval between cardiac catheterization and elective coronary artery bypass surgery with postprocedural acute kidney injury.

BACKGROUND: Some prior studies have suggested that the time to cardiac surgery after cardiac catheterization is inversely related to postoperative acute kidney injury (AKI). However, these studies, because of the small number of patients, were unable to adequately account for patient case-mix and included both those undergoing elective surgery and those undergoing urgent surgery. METHODS AND RESULTS: We examined data on 2441 consecutive patients undergoing elective coronary artery bypass surgery (CABG) after cardiac catheterization. The association of post-CABG AKI (defined as increase in post-CABG serum creatinine ≥ 50% above baseline or the need for new dialysis) and time between cardiac catheterization and CABG was evaluated using multivariable logistic regression modeling. AKI occurred in 17.1% of CABG patients. The risk of AKI was highest in patients in whom CABG was performed ≤ 1 day after cardiac catheterization (adjusted mean rates [95% CI]: 24.0% [18.0%, 30.9%], 18.4% [14.8%, 22.5%], 17.3% [13.3%, 21.9%], 16.4% [12.6%, 20.8%], and 15.8% [13.7%, 18.0%] for days ≤ 1, 2, 3, 4, and ≥ 5, respectively; P=0.019 for test of trend). Post-CABG AKI was associated with increased risk of long-term death (hazard ratio 1.268, 95% CI 1.093, 1.471). CONCLUSIONS: The risk of post-CABG AKI was inversely and modestly related to the time between cardiac catheterization and CABG, with the highest incidence in those operated ≤ 1 day after cardiac catheterization despite their lower risk profile. Whether delaying elective CABG >24 hours of exposure to contrast agents (when feasible) has the potential for decreasing post-CABG AKI remains to be evaluated in future studies.

Left circumflex occlusion in acute myocardial infarction (from the National Cardiovascular Data Registry).

Compared to occlusions of other major coronary arteries, patients presenting with acute left circumflex (LCx) occlusion usually have ST-segment elevation on the electrocardiogram <50% of the time, potentially delaying treatment and resulting in worse outcomes. In contemporary practice, little is known about the clinical outcomes of patients with LCx territory occlusion without ST-segment elevation myocardial infarction (STEMI). We identified patients with myocardial infarction from April 2004 to June 2009 in the CathPCI Registry treated with percutaneous coronary intervention for culprit LCx territory occlusion, excluding those with previous coronary artery bypass grafting. Logistic generalized estimating equation modeling was used to compare the outcomes, including in-hospital mortality between patients with STEMI and non-STEMI (NSTEMI) adjusting for differences in the baseline characteristics. Of the 27,711 patients with myocardial infarction and acute LCx territory occlusion, 18,548 (67%) presented with STEMI and 9,163 (33%) with NSTEMI. With the exception of a greater proportion of cardiac risk factors and cardiac history in the NSTEMI group, the demographic and baseline characteristics were clinically similar between the 2 groups, despite the statistical significance resulting from the large population. The patients with STEMI were more likely to have a proximal LCx culprit lesion (63% vs 27%, p <0.0001) and had greater risk-adjusted in-hospital mortality (odds ratio 1.36, 95% confidence interval 1.12 to 1.65, p = 0.002) compared to patients with NSTEMI. In conclusion, acute LCx territory occlusion often presents as NSTEMI, but patients with NSTEMI and occlusion have a lower mortality risk than those with STEMI, possibly because of factors such as the amount of myocardium involved, the lesion location along the vessel, and/or a dual blood supply.

Percutaneous coronary intervention in native arteries versus bypass grafts in prior coronary artery bypass grafting patients: a report from the National Cardiovascular Data Registry.

OBJECTIVES: This study examined a large registry to determine the frequency, predictors, and outcomes of native coronary artery versus bypass graft percutaneous coronary intervention (PCI) in patients with prior coronary artery bypass graft surgery (CABG). BACKGROUND: The PCI target vessel and corresponding outcomes in prior CABG patients are poorly studied. METHODS: We analyzed the frequency and factors associated with native versus bypass graft PCI in prior CABG patients undergoing PCI between January 1, 2004, and June 30, 2009, in the National Cardiovascular Data Registry (NCDR) CathPCI Registry. Generalized estimating equations logistic regression modeling was used to generate independent variables associated with native versus bypass graft PCI and in-hospital mortality. RESULTS: During the study period, PCI in prior CABG patients represented 17.5% of the total PCI volume (300,902 of 1,721,046). The PCI target was a native coronary artery in 62.5% and a bypass graft in 37.5%: saphenous vein graft (SVG) (104,678 [34.9%]), arterial graft (7,517 [2.5%]), or both arterial graft and SVG (718 [0.2%]). Compared with patients undergoing native coronary artery PCI, those undergoing bypass graft PCI had higher-risk characteristics and more procedural complications. On multivariable analysis, several parameters (including graft stenosis and longer interval from CABG) were associated with performing native coronary PCI, and bypass graft PCI was associated with higher in-hospital mortality (adjusted odds ratio: 1.22, 95% confidence interval: 1.12 to 1.32). CONCLUSIONS: Most PCIs performed in prior CABG patients are done in native coronary artery lesions. Compared with native coronary PCI, bypass graft PCI is independently associated with higher in-hospital mortality.

Extent of and reasons for nonuse of implantable cardioverter defibrillator devices in clinical practice among eligible patients with left ventricular systolic dysfunction.

BACKGROUND: Several studies that used claims and registry data have reported that 40% to 80% of patients eligible for an implantable cardioverter defibrillator (ICD) fail to receive one in clinical practice, and the rates are especially high among women and blacks. The extent and documented reasons for nonuse of ICDs among patients with left ventricular systolic dysfunction are unknown. METHODS AND RESULTS: Using hospital claims and clinical data, we identified patients hospitalized with a heart failure diagnosis and left ventricular ejection fraction ≤30% between January 1, 2007, and August 30, 2007, at a tertiary-care center. Using claims data, we determined placement of an ICD or cardiac resynchronization therapy with defibrillation device at any time up to 1 year after hospitalization. Medical records for patients without an ICD were abstracted to determine reasons for nonuse. Patients with an ICD were compared with patients without an ICD and also with patients without an ICD who did not have any contraindication for an ICD as identified through chart abstraction. Of the 542 potentially eligible patients identified, 224 (41%) did not have an ICD. In the initial adjusted analysis, female sex (odds ratio=1.90; 95% CI, 1.28 to 2.81) and increasing age (odds ratio=1.07; 95% CI, 1.04 to 1.11) were associated with a higher likelihood of not having an ICD. After detailed chart review, of the 224 patients without an ICD, 117 (52%) were ineligible for the device and 38 (17%) patients refused the device, resulting in only 69 (13%) patients eligible for an ICD who failed to receive one. In this subsequent adjusted analysis, remaining factors associated with a higher likelihood of not having an ICD were absence of ventricular arrhythmias (odds ratio=4.93; 95% CI, 2.56 to 9.50), noncardiology hospital service (odds ratio=3.73; 95% CI, 1.98 to 7.04), and lack of health insurance (odds ratio=3.10; 95% CI, 1.48 to 6.46). CONCLUSIONS: On the basis of a detailed chart review, the true rate of ICD underuse may be substantially lower than previous estimates. In addition, after accounting for ICD eligibility criteria, patient sex and age disparities in ICD therapy were no longer present.

Modifiable risk factors associated with sudden cardiac arrest within hemodialysis clinics.

Sudden cardiac arrest is the most common cause of death among patients with end-stage kidney disease (ESKD) maintained on hemodialysis. Here we sought to identify dialysis-related factors associated with this increased risk in a case-control study encompassing 43,200 patients dialyzed in outpatient clinics of a large organization. Within this group, we compared the clinical and dialysis-specific data of 502 patients who experienced a sudden cardiac arrest with 1632 age- and dialysis-vintage-matched controls. There were 4.5 sudden cardiac arrest events per 100,000 dialysis treatments during the 3-year study period. These patients were significantly more likely to have been exposed to low potassium dialysate of less than 2 meq/l. These differences could not be explained by predialysis serum potassium levels. There was no evidence for a beneficial effect of low potassium dialysate even among those with higher predialysis serum potassium levels. Other factors strongly associated with sudden cardiac arrest by multivariable analysis included increased ultrafiltration volumes, exposure to low calcium dialysate, and predialysis serum creatinine levels. These relationships persisted after adjustment for covariates, but traditional risk factors such as history of coronary heart disease and congestive heart failure were not significantly influential. Hence, our study suggests that modifications of the hemodialysis prescription may improve the risk of sudden cardiac arrest in patients with ESKD.

Impact of recovery of renal function on long-term mortality after coronary artery bypass grafting.

Whether prognosis differs in acute renal failure (ARF) after coronary artery bypass grafting (CABG) in patients with and without recovery of renal function is not known. We studied patients who had CABG at Duke University Medical Center (1995 to 2008). ARF was defined as an increase in peak creatinine ≥50% after CABG or ≥0.7 mg/dl above baseline or need for new dialysis. Patients were categorized into 3 groups: (1) no ARF after CABG, (2) ARF after CABG and completely recovered renal function at day 7 (return of creatinine to no higher than baseline and no dialysis), or (3) ARF after CABG with no recovery of renal function at day 7 (creatinine no higher than baseline or new dialysis). Main outcome measurement was risk-adjusted long-term mortality (excluding death ≤7 days). ARF after CABG occurred in 2,083 of 10,415 patients (20%) and completely recovered in 703 (33.7%). Risk-adjusted mortality was highest in patients with ARF without recovery of renal function (hazard ratios 1.47, 95% confidence interval 1.34 to 1.62) and intermediate in those with ARF but completely recovered renal function (hazard ratios 1.21, 95% confidence interval 1.07 to 1.37, referent no-ARF group). Mortality was lower in patients with ARF compared to those without complete recovery of renal function (p = 0.0083). In conclusion, in patients with ARF after CABG, complete recovery of renal function was associated with significantly lower long-term mortality compared to those without such recovery, although this was significantly higher than in those without ARF. Thus, major emphasis should be on prevention of ARF in patients undergoing CABG.

Influence of patient age on procedural selection in mitral valve surgery.

BACKGROUND: Previous studies suggest that mitral valve replacement is comparable to repair in the elderly, and a national trend exists toward tissue valves. However, few direct comparison data are available, and this study evaluated the effects of patient age on risk-adjusted survival after mitral procedures. METHODS: From 1986 to 2006, 2,064 patients underwent isolated primary mitral operations (±CABG). Maximal follow-up was 20 years with a median of 5 years. Valve disease etiology was the following: degenerative, 864; ischemic, 450; rheumatic, 416; endocarditis, 98; and "other," 236. Overall, 58% had repair and 39% had concomitant coronary artery bypass grafting. Survival differences were evaluated with a Cox proportional hazards model that included baseline characteristics, valve disease etiology, and choice of repair versus replacement with tissue or mechanical valves. RESULTS: Baseline risk profiles generally were better for mechanical valves, and age was the most significant multivariable predictor of late mortality [hazard ratio = 1.4 per 10-year increment, Wald χ(2) = 32.7, p < 0.0001]. As compared with repair, risk-adjusted survival was inferior with either tissue valves [1.8, 27.6, <0.0001] or mechanical valves [1.3, 8.1, 0.0044], and no treatment interaction was observed with age (p = 0.18). At no patient age did tissue valves achieve equivalent survival to either repair or mechanical valves. CONCLUSIONS: Mitral repair is associated with better survival than valve replacement across the spectrum of patient age. If replacement is required, mechanical valves achieve better outcomes, even in the elderly. These data suggest that tissue valves should be reserved only for patients with absolute contraindications to anticoagulation who are not amenable to repair.

Racial differences in long-term survival among patients with coronary artery disease.

BACKGROUND: Cardiovascular disease is the leading cause of death among blacks and whites in the United States. Despite this, there are insufficient data on the long-term prognosis of black patients with coronary artery disease (CAD) as well as the major clinical related determinants of outcome. METHODS: We studied 22,618 patients (3,314 black) having significant CAD findings at cardiac catheterization performed at Duke from January 1986 to December 2004 with follow-up through June 2006. Using Kaplan-Meier and Cox modeling, we compared unadjusted and adjusted long-term survival by patient race and gender (median follow-up 7.6 years, interquartile range 3.5-13.0) as well as identified major patient characteristics associated with survival. RESULTS: Blacks with CAD were younger; were more often female; had lower median household incomes; and had more hypertension, diabetes mellitus, and heart failure. The number of coronary vessels with significant disease was similar by race. At 15-year follow-up, black women had the lowest survival and white men had the highest (41.5% vs 45.8%, P < .0001). Blacks were less likely to receive initial therapy with coronary revascularization (odds ratio 0.66, 95% CI 0.60-0.72, P < .0001). After adjusting for baseline clinical and demographic characteristics and initial treatment selection, black race remained an independent predictor of lower survival (hazard ratio 2.54, 95% CI 1.60-4.04, P < .0001). CONCLUSIONS: Among patients with CAD, blacks have lower long-term survival compared with whites. The difference may be partially, but not fully, explained by differences in cardiovascular risk factors and 30-day revascularization rates.