Physician assessment of aortic stenosis severity, quantitative parameters, and long-term outcomes: Results from the KP-VALVE project.

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.

Very late stent thrombosis with second generation drug eluting stents compared to bare metal stents: Network meta-analysis of randomized primary percutaneous coronary intervention trials.

BACKGROUND: The relative safety of drug-eluting stents (DES) and bare-metal stents (BMS) in primary percutaneous coronary intervention (PPCI) in ST elevation myocardial infarction (STEMI) continues to be debated. The long-term clinical outcomes between second generation DES and BMS for primary percutaneous coronary intervention (PCI) using network meta-analysis were compared. METHODS: Randomized controlled trials comparing stent types (first generation DES, second generation DES, or BMS) were considered for inclusion. A search strategy used Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion criteria, and sample characteristics were extracted. Network meta-analysis was used to pool direct (comparison of second generation DES to BMS) and indirect evidence (first generation DES with BMS and second generation DES) from the randomized trials. RESULTS: Twelve trials comparing all stents types including 9,673 patients randomly assigned to treatment groups were analyzed. Second generation DES was associated with significantly lower incidence of definite or probable ST (OR 0.59, 95% CI 0.39-0.89), MI (OR 0.59, 95% CI 0.39-0.89), and TVR at 3 years (OR 0.50: 95% CI 0.31-0.81) compared with BMS. In addition, there was a significantly lower incidence of MACE with second generation DES versus BMS (OR 0.54, 95% CI 0.34-0.74) at 3 years. These were driven by a higher rate of TVR, MI and stent thrombosis in the BMS group at 3 years. There was a non-significant reduction in the overall and cardiac mortality [OR 0.83, 95% CI (0.60-1.14), OR 0.88, 95% CI (0.6-1.28)] with the use of second generation DES versus BMS at 3 years. CONCLUSIONS: Network meta-analysis of randomized trials of primary PCI demonstrated lower incidence of MACE, MI, TVR, and stent thrombosis with second generation DES compared with BMS. © 2016 Wiley Periodicals, Inc.

Management of drug eluting stent in-stent restenosis: A systematic review and meta-analysis.

BACKGROUND: The optimal management for coronary drug eluting stent in-stent restenosis (DES ISR) is unclear. We performed a meta-analysis of observational and randomized studies to compare the outcomes of management of DES ISR using DES, drug eluting balloon (DEB), or balloon angioplasty (BA). METHODS: Eligible studies (25 single arm and 13 comparative, including 4 randomized studies with a total of 7,474 patients with DES ISR) were identified using MEDLINE search and proceedings of international meetings. Outcomes studied include major adverse cardiac events (MACE), target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), stent thrombosis (ST), and mortality. Follow-up ranged from 0.5 to 3.5 years (mean 1.4 years). RESULTS: The rate of TLR was significantly lower in the DES (odds ratio [OR] 0.50, 95% confidence interval [CI] 0.36-0.69) and DEB (OR 0.31, 95% CI 0.18-0.55) groups compared to BA. Similarly, TVR rate was significantly lower in the DES (OR 0.55, 95% CI 0.39-0.77) and DEB (OR 0.32, 95% CI 0.18-0.58) groups compared to BA. All other outcomes were similar between the DES/BA and DEB/BA comparisons. TLR was significantly lower in the DES group compared to BA for vessels < or > 2.75 mm. CONCLUSION: Treatment of coronary DES ISR with DES or DEB is associated with a reduction in the risk of TLR and TVR compared to BA alone. The relative risk reduction for TLR with DES is similar to DEB. DEBs have a potential role in the treatment of DES ISR by avoiding placement of another layer of stent. © 2015 Wiley Periodicals, Inc.

Aortic annulus and root characteristics in severe aortic stenosis due to bicuspid aortic valve and tricuspid aortic valves: implications for transcatheter aortic valve therapies.

BACKGROUND: Patients with severe aortic stenosis due to BAV are excluded from transcatheter aortic valve replacement (TAVR) due to concern for asymmetric expansion and valve dysfunction. We sought to characterize the aortic root and annulus in bicuspid aortic valve (BAV) and tricuspid aortic valves (TAV). METHODS AND RESULTS: We identified patients with severe AS who underwent multi-detector computed tomographic (MDCT) imaging prior to surgical aortic valve replacement (SAVR, n = 200) for BAV and TAVR (n = 200) for TAV from 2010 to 2013. The presence of a BAV was confirmed on surgical and pathological review. Annulus measurements of the basal ring (short- and long-axis, area-derived diameter), coronary ostia height, sinus area (SA), sino-tubular junction area (STJ), calcification and eccentricity index (EI, 1-short axis/long axis) were made. Patients with TAV were older (78.8 years vs. 57.8 years, P = 0.04) than those with BAV. The aortic annulus area (5.21 ± 2.1 cm(2) vs. 4.63 ± 2.0 cm(2) , P = 0.0001), sinus of Valsalva diameter (3.7 ± 0.9 cm vs. 3.1 ± 0.1 cm, P = 0.001) and ascending aorta diameter (3.5 ± 0.7 cm vs. 2.97 ± 0.6 cm, P = 0.001) were significantly larger with BAV. Bicuspid aortic annuli were significantly less elliptical (EI, 1.24 ± 0.1 vs. 1.29 ± 0.1, P = 0.006) and more circular (39% vs. 4%, P < 0.001) compared to the TAV annulus. There was more eccentric annular calcification in BAV vs. TAV (68% vs. 32%, P < 0.001). The mean distance from the aortic annulus to the left main coronary ostium was less than the right coronary ostium. Less than 10% of the BAV annuli would not fit a currently available valved stents. CONCLUSION: Bicuspid aortic valves have a larger annulus size, sinus of Valsalva and ascending aorta dimensions. In addition, the BAV aortic annuli appear circular and most will fit currently available commercial valved stents.

MitraClip for severe symptomatic mitral regurgitation in patients at high surgical risk: a comprehensive systematic review.

BACKGROUND: The optimal treatment of patients with severe mitral regurgitation (MR) at high surgical risk (HSR) is unknown. Recently, the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study suggested MitraClip (MC) was a safe and effective treatment option. METHODS: We performed a search strategy for MC or mitral valve surgery (MVS) in patients at HSR for surgical mortality (logistic EuroSCORE >18 or STS score > 10) using Medline databases, proceedings of international meetings, and the STS database. We identified 21 studies utilizing MC (n = 3,198) and MVS (n = 3,265, >90% from the STS database) from 2003 to 2013. Information about patient characteristics, surgical risk, and 30-day and 1-year outcomes were extracted. RESULTS: Patients who underwent MC or MVS had a mean age of 74 ± 10 years with no differences in surgical risk, NYHA class, or MR grade (P = 0.46). Technical success was achieved in 96% of patients undergoing MC versus 98% in the MVS group (P = 0.45). Patients undergoing MC were treated with one or two MC in 90% (n = 2,878) with only a few requiring repeat MC (0.4%, n = 13) or mitral surgery (0.3%, n = 52) at 30 days. The pooled event rates for mortality was 3.2% (95% CI [2.5-4.2]), stroke was 1.1% (95% CI [0.7-0.2]) at 30 days. At 31 days to 1 year, the pooled event rate for mortality was 13.0% [95% CI (9-18.3)], stroke was 1.6% [95% CI (0.8-3.2)], and repeat MVS was 1.3% [95% CI (0.7-2.6)] with the majority of patients in the mild/moderate MR grade and NYHA class after MC. The 30-day event rates for mortality and stroke were 16.8% (95% CI [14-19]) and 4.5% (95% CI [3.9-5.3]) after MVS, respectively. CONCLUSION: Based on high risk MC studies and high risk MVS data predominantly from STS database, patients with severe MR who are at HSR can be effectively treated with MC or MVS. MC can be safely implanted in high risk patients with relatively low mortality and stroke risk.

Characterization of internal pudendal artery atherosclerosis using aortography and multi-detector computed angiography.

OBJECTIVE: To compare multi-detector computed tomography (MDCT) and aortography in the assessment of the internal pudendal artery (IPA) anatomy and degree of atherosclerosis. METHODS: Eighty-three patients underwent MDCT and aortography of the pelvic vasculature prior to consideration for transcatheter aortic valve replacement. These modalities were used to localize the IPA origin, degree of stenosis (normal: <50% stenosis or abnormal: >50% stenosis or occlusion), normal= and extent of calcification, quantified using a nominal scale (0 = no calcification, 1 = <25%, 2 = 25-50%, 3 = >50% of the IPA length). These studies were read independently and were blinded. RESULTS: Mean patient age was 78 ± 8 years with a high prevalence of atherosclerotic disease (70% coronary artery disease (CAD) and 30% peripheral artery disease (PAD)). The prevalence of having IPA stenosis or occlusion was 54%, 18% had an accessory arterial origin. In a patient-based analysis, the sensitivity of MDCT for detecting significant proximal IPA disease was 100% and, specificity 74%, positive predictive valve was 66%, and negative predictive value was 100%. In assessing the distal IPA and cavernosal arteries, the sensitivity was 100%, specificity was 64%, positive predictive value 89%, and negative predictive value of 100%. MDCT used significantly more contrast and more radiation than aortography. CONCLUSION: MDCT had a high false-positive rate and low false-negative rate in evaluating the proximal IPA. For the distal IPA or cavernosal arteries, MDCT showed a high sensitivity and low specificity. These modalities have complementary roles in the assessment of IPA patency.

Current state of endovascular treatment for vasculogenic erectile dysfunction.

Normal erectile function requires adequate penile arterial inflow, normal penile architecture and an intact venous capacitance system. Vascular disease is the dominant etiology of erectile dysfunction (ED) and current medical therapy increases penile blood flow. However, in a large proportion of patients, medical therapy is inadequate or contraindicated requiring the use of mechanical constrictive devices or implantation of a penile prosthesis. Rapid advances in endovascular intervention have allowed safe and effective treatment of small arteries in other vascular beds. A minimally invasive approach targeting penile arterial inflow disease may prove to be safe and effective. In this paper, we discuss the normal arterial blood supply to the penis, describe angiographic findings in patients with ED, and critically review the published data on endovascular and microsurgical approaches at reestablishing penile blood flow. Lastly, we offer a potential algorithm and procedural tips for endovascular intervention for ED.

Echocardiographic and Clinical Outcomes in Symptomatic Patients With Less Than Severe Aortic Stenosis After Supra-Annular Self-Expanding Transcatheter Aortic Valve Replacement.

Optimal timing for aortic valve replacement in symptomatic patients with less than severe aortic stenosis (AS) is not well defined. There is limited information on the benefit of valve replacement in these patients. Symptomatic patients with less than severe AS, defined as a mean aortic gradient ≥20 and <40 mm Hg, peak aortic velocity >3 and <4 m/s, and aortic valve area >1.0 and <1.5 cm2, enrolled in the Society for Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry and who underwent attempted supra-annular, self-expanding transcatheter aortic valve replacement (TAVR) were reviewed. Site-reported valve hemodynamics, clinical events, and quality of life metrics were analyzed at 30 days and 1 year after the procedure. A total of 1,067 patients with attempted TAVR (mean age 78.4 ± 8.4 years; Society for Thoracic Surgery score 4.7 ± 3.4%) were found to have symptoms but less than severe AS. From baseline to postprocedure, mean gradient decreased (29.9 ± 4.9 vs 8.4 ± 4.8 mm Hg, p <0.001), and aortic valve area increased (1.2 ± 0.1 vs 2.2 ± 0.7 cm2, p <0.001). Clinical events included 30-day and 1-year all-cause mortality (1.5% and 9.6%), stroke (2.2% and 3.3%), and new pacemaker implantation (18.1% and 20.9%). There were statistically significant improvements in the New York Heart Association functional class and Kansas City Cardiomyopathy Questionnaire at 30 days and 1 year. In conclusion, patients with symptomatic but less than severe AS who underwent supra-annular, self-expanding TAVR experienced improved valve hemodynamics and quality of life measures 1 year after the procedure. Randomized studies of TAVR versus a control arm in symptomatic patients with less than severe AS are ongoing.

Outcomes of Adults with Severe Aortic Stenosis Undergoing Urgent or Emergent vs. Elective Transcatheter Aortic Valve Replacement Within an Integrated Health Care Delivery System.

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.

Temporal trends in the prevalence and severity of aortic stenosis within a contemporary and diverse community-based cohort.

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.

Non-invasive volumetric assessment of aortic atheroma: a core laboratory validation using computed tomography angiography.

Aortic atherosclerosis has been linked with worse peri- and post-procedural outcomes following a range of aortic procedures. Yet, there are currently no standardized methods for non-invasive volumetric pan-aortic plaque assessment. We propose a novel means of more accurately assessing plaque volume across whole aortic segments using computed tomography angiography (CTA) imaging. Sixty patients who underwent CTA prior to trans-catheter aortic valve implantation were included in this analysis. Specialized software analysis (3mensio Vascular™, Pie Medical, Maastricht, Netherlands) was used to reconstruct images using a centerline approach, thus creating true cross-sectional aortic images, akin to those images produced with intravascular ultrasonography. Following aortic segmentation (from the aortic valve to the renal artery origin), atheroma areas were measured across multiple contiguous evenly spaced (10 mm) cross-sections. Percent atheroma volume (PAV), total atheroma volume (TAV) and calcium score were calculated. In our populations (age 79.9 ± 8.5 years, male 52 %, diabetes 27 %, CAD 84 %, PVD 20 %), mean ± SD number of cross sections measured for each patient was 35.1 ± 3.5 sections. Mean aortic PAV and TAV were 33.2 ± 2.51 % and 83,509 ± 17,078 mm(3), respectively. Median (IQR) calcium score was 1.5 (0.7-2.5). Mean (SD) inter-observer coefficient of variation and agreement for plaque area among 4 different analysts was 14.1 (5.4), and the mean (95 % CI) Lin's concordance correlation coefficient was 0.79 (0.62-0.89), effectively simulating a Core Laboratory scenario. We provide an initial validation of cross-sectional volumetric aortic atheroma assessment using CTA. This proposed methodology highlights the potential for utilizing non-invasive aortic plaque imaging for risk prediction across a range of clinical scenarios.

Impact of statins and beta-blocker therapy on mortality after coronary artery bypass graft surgery.

BACKGROUND: We conducted a retrospective cohort study of patients after first-time isolated coronary artery bypass graft surgery (CABG) and assessed the impact of a discharge regimen including beta-blockers and statin therapy and their relationship to long-term all cause mortality and major adverse cardiovascular events (MACE). METHODS: We identified patients age >18 years, undergoing first time isolated CABG from 1993 to 2005. Patients were identified using the Cardiovascular Information Registry (CVIR). We collected follow-up information at 30, 60, 90 days and yearly follow-up. The registry is approved for use in research by the institutional review broad. RESULTS: We identified 5,205 patients who underwent single isolated CABG between January 1993 and December 2005. The mean age was 64.5±9.7 years and over 70% were male. There was a significant difference in the low density lipoproteins (LDL) concentration between those with or without statin medications (134±41.9 mg/dL) (no statin) vs. 126±44.8 mg/dL (with statin), P=0.001. A discharge regimen with statin therapy was associated with and overall reduction in 30 day, 1 year and long-term mortality. In addition, overall the triple ischemic endpoint of death, myocardial infarction (MI) and stroke was also significantly lower in the statin vs. no-statin group. In addition, statin and beta-blockers exerted synergistic effect on overall mortality outcomes short-term and in the long-term. We note that the predictors of overall death include no therapy with statin therapy and age [hazard ratios (HR) 1.1, 95% CI: 1.04-1.078, P<0.001] and presence of renal failure (HR 2.0, P=0.005). The estimated 11-year Kaplan Meier curves for mortality between the two groups starts to diverge immediately post discharge after single isolated CABG and continue to diverge through out the follow-up period. CONCLUSIONS: A post-discharge regimen of statins independently reduces overall and 1 year mortality. These results confirm those of earlier studies within a contemporary surgical population and support the current clinical guidelines.

Transient post-operative atrial fibrillation predicts short and long term adverse events following CABG.

OBJECTIVE: To assess the relationship between the development of transient post-operative atrial fibrillation (TPOAF) following coronary artery bypass graft (CABG) surgery and risk of long-term mortality. BACKGROUND: Atrial fibrillation (AF) following CABG is common and associated with increased morbidity and mortality in the perioperative period. However the impact of TPOAF and its management on long-term morbidity and mortality in patients undergoing first time, isolated CABG surgery remains unclear. METHODS: The Cleveland Clinic Cardiovascular Information Registry was used to identify 5,205 consecutive patients who underwent CABG between January 1993 and December 2005. Patients with TPOAF (n=1,490) were compared to those without post-operative AF (n=3,645) for the endpoints of death, myocardial infarction (MI), or stroke at 1 year. RESULTS: Overall rates of 1-year mortality, MI and stroke were 3.7%, 0.8%, and 2.6%, respectively. Patients with TPOAF had an increased risk of death at 1 year as compared to patients without POAF (6.4% vs. 2.7%; P<0.001), but there was not an increased risk of stroke or MI. Multivariate analysis identified TPOAF as an independent predictor of death at 1 year (HR 1.89, 95% CI, 1.42-2.53; P<0.001). After propensity matching, patients who developed TPOAF experienced a significantly increased risk of death compared with those without TPOAF (HR 1.96, 95% CI, 1.34-2.86; P<0.001). CONCLUSIONS: In patients undergoing first time, isolated CABG, the presence of TPOAF identifies a subgroup of patients at increased risk for all-cause mortality. Future prospective studies to determine potential beneficial interventions in this large population are warranted.

The impact of renal artery stenosis on outcomes after open-heart surgery.

OBJECTIVES: The aim of this study was to assess the impact of atherosclerotic renal artery stenosis (ARAS) on outcomes after open-heart surgery (OHS). BACKGROUND: Acute kidney injury after OHS portends significant morbidity and mortality. METHODS: Data from all adult patients undergoing OHS from January 2000 to April 2010 who underwent renal duplex ultrasound were prospectively collected. ARAS was severe (60% to 99% stenosis) if peak systolic velocity was >200 cm/s. The associations between ARAS and post-operative reduction in glomerular filtration rate (GFR), need for renal replacement therapy, length of stay, and overall short-term and long-term mortality (up to 8 years) were tested using multivariate time-to-event adjusted analysis. RESULTS: A total of 714 patients were evaluated, with a mean age of 67 ± 12 years (63% men) and a mean GFR of 52 ± 25.9 ml/min/1.73 m(2). A total of 206 (29%) had ARAS; of these, 79% (n = 163) had unilateral and 21% (n = 43) had bilateral ARAS. ARAS was associated with peripheral artery disease (p = 0.004) and lower high-density lipoprotein levels (p = 0.04). Patients with advanced age (p = 0.01) and descending aorta grafting (p = 0.004) had significant post-operative reductions in GFR. Adjusted models showed a nonsignificant trend between ARAS and reduction in GFR (p = 0.09). ARAS was not associated with need for renal replacement therapy (p = 0.4), longer length of stay (p = 0.7), or mortality (p = 0.7), but low pre-operative GFR was a strong predictor of long-term mortality. CONCLUSIONS: ARAS does not appear to be associated with post-operative change in GFR, need for hemodialysis, longer length of stay, or mortality in patients undergoing OHS.

Stent thrombosis with second-generation drug-eluting stents compared with bare-metal stents: network meta-analysis of primary percutaneous coronary intervention trials in ST-segment­elevation myocardial infarction [corrected].

BACKGROUND: The relative safety of drug-eluting stents (DESs) and bare-metal stents (BMSs) with respect to stent thrombosis (ST) continues to be debated. There are limited data comparing safety and efficacy of second-generation DES to BMS. We compared the clinical outcomes between second-generation DES and BMS for primary percutaneous coronary intervention using network meta-analysis. METHODS AND RESULTS: Randomized controlled trials comparing stent types (first-generation DES, second-generation DES or BMS) were considered for inclusion. A search strategy used Medline, Embase, Cochrane databases, and proceedings of the international meetings. Information about study design, inclusion criteria, and sample characteristics were extracted. Network meta-analysis was used to pool direct (comparison of second-generation DES to BMS) and indirect evidence (first-generation DES with BMS and second-generation DES) from the randomized trials. Twenty-one trials comparing all stents types, including 12 866 patients randomly assigned to treatment groups, were analyzed. A significantly lower incidence of ST was noted with the use of second-generation DES as early as 30 days (odds ratio [OR], 0.36; 95% confidence interval [CI], 0.15-0.82) and between 31 days and 1 year (OR, 0.49; 95% CI, 0.30-0.79) when compared with BMS. Second-generation DES was associated with significantly lower incidence of definite ST at 1 year (OR, 0.3; 95% CI, 0.11-0.83) and myocardial infarction (OR, 0.3; 95% CI, 0.17-0.54) and target vessel revascularization at 1 year (OR, 0.54; 95% CI, 0.80-0.98) when compared with BMS. There was no difference in mortality at 30 days (OR, 0.84; 95% CI, 0.45-1.59) or 1 year (OR, 0.80; 95% CI, 0.56-1.14) with the use of second-generation DES versus BMS. The small number of events may influence the precision of the analysis. CONCLUSIONS: Network meta-analysis of randomized trials of primary percutaneous coronary intervention demonstrated lower incidence of ST, myocardial infarction, and target vessel revascularization with second-generation DES when compared with BMS. The use of second-generation DES for percutaneous coronary intervention in ST-segment-elevation myocardial infarction was not associated with adverse events when compared with BMS.

Pulmonary vein isolation for the treatment of drug-refractory atrial fibrillation in adults with congenital heart disease.

BACKGROUND: Atrial fibrillation (AF) is a common arrhythmia in adults with congenital heart disease (CHD). Long-term antiarrhythmic therapy (AAT) in these patients has significant shortcomings. The safety and efficacy of pulmonary vein antrum isolation (PVAI) for the treatment of AF in CHD is presently unknown. HYPOTHESIS: We hypothesized that PVAI for AF in patients with CHD is effective and safe. METHODS: We reviewed a prospective cohort of 4315 patients (age ≥ 18) undergoing PVAI for drug refractory AF at a single institution and identified 36 consecutive patients with CHD (single ventricle physiology, tetralogy of Fallot, coarctation of the aorta, ventricular septal defects, atrial septal defects (ASD) and cardiomyopathy resulting from anomalous origin of the left main coronary from the pulmonary artery). A second cohort of 355 consecutive patients with noncongenital structural heart disease (NSHD) (coronary artery disease, valvular heart disease, ejection fraction <50%, or prior noncongenital cardiac surgery) undergoing PVAI during the same time period was used as a control. Success was defined as freedom from AF starting two months after PVAI in the absence AAT until the end of follow-up. Partial success was defined as freedom from AF in the presence of AAT until the end of follow-up. Combined success was defined as the sum of success and partial success. We compared the outcomes with the use of propensity-score matching in the overall cohort. RESULTS: Patients with NSHD were older and had higher prevalence of hypertension (P < .01), diabetes (P < .01) and hyperlipidemia (P < .01). The most common CHD lesion was ASD (61%) and the most common NSHD lesion was valvular heart disease (57%). After one PVAI, success was achieved in 42% and 53% at 300 days in the CHD and NSHD groups respectively. Four-year success was achieved in 27% and 36% in the CHD and NSHD groups, respectively. There were no significant differences in the success rates between patients groups (P= .46), nor were there any differences in left atrial size or changes in ejection fraction after one or two PVAI in the respective groups. Complication rates between the CHD and NSHD groups were similar (15% vs. 11%, P= .42) except for a higher risk of vascular site complications in patients with CHD (8% vs. 1%, P < .05). CONCLUSION: PVAI is an attractive treatment modality in drug refractory AF in CHD, with combined success rates in excess of 60%. The maintenance of sinus rhythm after PVAI in CHD appears similar to that of NSHD and warrants prospective validation.