Citations 350

Transcatheter Valve Therapy Registry Is A Model For Medical Device Innovation And Surveillance

Health Affairs | February 2, 2015 | Volume: 34 | Issue: 2 | Pages: 328-334

10.1377/hlthaff.2014.1010 | PMID 25646114

Spontaneous Coronary Artery Dissection

Circulation: Cardiovascular Interventions | November 18, 2014 | Volume: 7 | Issue: 6 | Pages: 777-786

10.1161/circinterventions.114.001659 | PMID 25406203

Background— Spontaneous coronary artery dissection (SCAD) is a nonatherosclerotic acute coronary syndrome for which optimal management remains undefined. Methods and Results— We performed a retrospective study of 189 patients presenting with a first SCAD episode. We evaluated outcomes according to initial management: (1) revascularization versus conservative therapy and (2) percutaneous coronary intervention (PCI) versus conservative therapy stratified by vessel flow at presentation. Demographics were similar in revascularization versus conservative (mean age, 44±9 years; women 92% both groups), but vessel occlusion was more frequent in revascularization (44/95 versus 18/94). There was 1 in-hospital death (revascularization) and 1 late death (conservative). Procedural failure rate was 53% in those managed with PCI. In the subgroup of patients presenting with preserved vessel flow, rates of PCI failure were similarly high (50%), and 6 (13%) required emergency coronary artery bypass grafting. In the conservative group, 85 of 94 (90%) had an uneventful in-hospital course, but 9 (10%) experienced early SCAD progression requiring revascularization. Kaplan–Meier estimated 5-year rates of target vessel revascularization and recurrent SCAD were no different in revascularization versus conservative therapy (30% versus 19%; P =0.06 and 23% versus 31%; P =0.7). Conclusions— PCI for SCAD is associated with high rates of technical failure even in those presenting with preserved vessel flow and does not protect against target vessel revascularization or recurrent SCAD. A strategy of conservative management with prolonged observation may be preferable.
Neuroimaging patterns of ischemic stroke after percutaneous coronary intervention

Catheterization and Cardiovascular Interventions | September 25, 2014 | Volume: 85 | Issue: 6 | Pages: 1033-1040

10.1002/ccd.25678 | PMID 25256948

ObjectivesWe sought to determine neuroimaging patterns, ischemic mechanisms, and functional outcomes of ischemic stroke related to percutaneous coronary intervention (PCI) over a 16‐year period. Background: Stroke is a feared complication of PCI, associated with poor patient outcomes. The majority of strokes that occur after PCI are ischemic rather than hemorrhagic. However, mechanisms of cerebral ischemia in this setting are incompletely understood.MethodsWe performed a retrospective single‐center cohort study of patients with radiologically confirmed ischemic stroke occurring after PCI (PCI‐stroke), between January 1, 1994 and December 31, 2009. Using brain imaging, infarctions were subclassified by radiological pattern and arterial territory as embolic, small subcortical, or hemodynamic. Modified Rankin Scale scores were used to assess functional outcome at 3 and 6 months.ResultsRadiologically confirmed PCI‐stroke was identified in 35 patients. The majority of strokes (91%) revealed an embolic pattern, while the remaining strokes were small subcortical infarctions (9%). Watershed strokes with exclusive borderzone involvement, indicative of a hemodynamic mechanism, were not identified, despite the presence of periprocedural hypotension in 23% of patients. The middle cerebral artery (MCA) territory was affected most frequently (80%), and all patients suffering a complete MCA territorial infarction (14%) died in the hospital. Functional outcome among survivors of PCI‐stroke was typically favorable in those who had single rather than multiple vascular territory involvement.ConclusionsThe vast majority of radiologically confirmed ischemic strokes related to PCI are embolic. MCA territory strokes are most common and uniformly fatal when the entire MCA territory is affected. Functional outcomes in survivors of PCI‐stroke are improved when only a single arterial territory is affected. © 2014 Wiley Periodicals, Inc.
Defining the Optimal Cardiac Troponin T Threshold for Predicting Death Caused by Periprocedural Myocardial Infarction After Percutaneous Coronary Intervention

Circulation: Cardiovascular Interventions | July 23, 2014 | Volume: 7 | Issue: 4 | Pages: 533-542

10.1161/circinterventions.113.000544 | PMID 25052010

Background— There is controversy about the diagnostic and prognostic significance of percutaneous coronary intervention–related myocardial infarction, especially with the use of cardiac troponin T (cTnT). This analysis was designed to address the question of the presence and the level of a prognostic cTnT threshold. Methods and Results— We evaluated 5268 consecutive patients who underwent nonemergent percutaneous coronary intervention between 2000 and 2009 with a preprocedural cTnT level below the upper limit of normal (ULN, ≤0.01 ng/mL). Postprocedural cTnT and creatine kinase-MB mass levels (ULN, 6.7 ng/mL in men and 3.8 ng/mL in women) were found to be associated with 3-month mortality in Cox proportional hazard models (hazard ratio per doubling of cTnT, 1.24; 95% confidence interval, 1.08–1.43; P =0.003 and hazard ratio per doubling of creatine kinase-MB, 1.30; 95% confidence interval, 1.05–1.60; P =0.018), adjusted for the Mayo Clinic risk scores for in-hospital and postdischarge mortality. The optimal prognostic threshold for 3-month mortality was 25× ULN for cTnT (hazard ratio, 4.53; 99% confidence interval, 1.59–12.9; P <0.001), which provided similar information as a value of 5× ULN for creatine kinase-MB (hazard ratio, 4.31; 99% confidence interval, 1.27–14.6; P =0.002). The cumulative mortality rate was 0.6% at 91 days. Conclusions— A significant association of postpercutaneous coronary intervention cardiac biomarker elevation with a small number of postpercutaneous coronary intervention outcomes was noted for the early (first 91 days) follow-up period with an identifiable optimal threshold of 25× ULN (0.25, ng/mL) for cTnT, which provided similar early outcome information as a cutoff of 5× ULN for creatine kinase-MB.
Fibrosing Mediastinitis

Circulation | July 14, 2014 | Volume: 130 | Issue: 3 | Pages: 290-291

10.1161/circulationaha.114.010166 | PMID 25024126

Comparison of manual and semiautomated techniques for analyzing gastric volumes with MRI in humans

American Journal of Physiology-Gastrointestinal and Liver Physiology | July 11, 2014 | Volume: 307 | Issue: 5 | Pages: G582-G587

10.1152/ajpgi.00048.2014 | PMID 25012844

Gastric emptying, accommodation, and motility can be quantified with magnetic resonance imaging (MRI). The first step in image analysis entails segmenting the stomach from surrounding structures, usually by a time-consuming manual process. We have developed a semiautomated process to segment and measure gastric volumes with MRI. Gastric images were acquired with a three-dimensional gradient echo MRI sequence at 5, 10, 20, and 30 min after ingestion of a liquid nutrient (Ensure, 296 ml) labeled with gadolinium in 20 healthy volunteers and 29 patients with dyspeptic symptoms. The agreement between gastric volumes measured by manual segmentation and our new semiautomated algorithm was assessed with Lin's concordance correlation coefficient (CCC) and the Bland Altman test. At 5 min after a meal, food volumes measured by manual (352 ± 4 ml) and semiautomated (346 ± 4 ml) techniques were correlated {CCC[95% confidence interval (CI)] 0.70 (0.52, 0.81)}; air volumes measured by manual (88 ± 6 ml) and semiautomated (84 ± 6 ml) techniques were also correlated [CCC (95% CI) 0.89 (0.82, 0.94)]. Findings were similar at subsequent time points. The Bland Altman test was not significant. The time required for semiautomated segmentation ranged from an average of 204 s for the 5-min images to 233 s for the 20-min images. These times were appreciably smaller than the typical times of many tens of minutes, even hours, required for manual segmentation. To conclude, a semiautomated process can measure gastric food and air volume using MRI with comparable accuracy and far better efficiency than a manual process.
Prognostic implications of severe coronary calcification in patients undergoing coronary artery bypass surgery: An analysis of the SYNTAX Study

Catheterization and Cardiovascular Interventions | May 14, 2014 | Volume: 85 | Issue: 2 | Pages: 199-206

10.1002/ccd.25545 | PMID 24824456

ObjectivesTo investigate the prognostic implications of the presence of severe lesion calcification in patients undergoing coronary artery bypass graft (CABG) operation.BackgroundThere is robust evidence that lesion calcification is a predictor of worse prognosis in patients undergoing percutaneous coronary intervention; however, there is limited data about the prognostic implication of lesion calcium in patients treated with CABG.MethodsWe retrospectively analyzed data from 1,545 patients who underwent CABG and were recruited in the SYNTAX study and CABG registry. Two experts reviewed the angiographic data and classified patients in two groups: those with severely calcified coronary arteries and those without severe lesion calcification. Clinical outcomes at 5‐year follow‐up were collected and compared in the two groups.ResultsOne out of three patients exhibited severe lesion calcification (n = 588). Patients with calcified coronaries had an increased mortality at 5‐year follow‐up (17.1% vs. 9.9%, P < 0.001) and a higher event rate of death‐myocardial infarction (MI) compared with those without (19.4% vs. 13.2%, P = 0.003), but there was no statistical significant difference between the two groups for major adverse cardiovascular events (MACE, 26.8% vs. 21.8%, P = 0.057). In multivariate Cox regression analysis severe lesion calcification was an independent predictor of an increased all‐cause mortality (hazard ratio: 1.39, 95% confidence interval: 1.02–1.89; P = 0.037) but it was not an independent predictor of the combined end‐points death‐MI or MACE.ConclusionsSevere lesion calcification is associated with an increased mortality in patients undergoing CABG, but it is not an independent predictor of death‐MI or MACE. This paradox can be attributed to the fact that CABG allows perfusion of the healthy coronaries bypassing the diseased arteries and thus it minimizes the risk of coronary events due to progressive atherosclerosis. © 2014 Wiley Periodicals, Inc.
Five-Year Outcomes in Patients With Left Main Disease Treated With Either Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting in the Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery Trial

Circulation | April 4, 2014 | Volume: 129 | Issue: 23 | Pages: 2388-2394

10.1161/circulationaha.113.006689 | PMID 24700706

Background— Current guidelines recommend coronary artery bypass graft surgery (CABG) when treating significant de novo left main coronary artery (LM) stenosis; however, percutaneous coronary intervention (PCI) has a class IIa indication for unprotected LM disease in selected patients. This analysis compares 5-year clinical outcomes in PCI- and CABG-treated LM patients in the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) trial, the largest trial in this group to date. Methods and Results— The SYNTAX trial randomly assigned 1800 patients with LM or 3-vessel disease to receive either PCI (with TAXUS Express paclitaxel-eluting stents) or CABG. The unprotected LM cohort (N=705) was predefined and powered. Major adverse cardiac and cerebrovascular event rates at 5 years was 36.9% in PCI patients and 31.0% in CABG patients (hazard ratio, 1.23 [95% confidence interval, 0.95–1.59]; P =0.12). Mortality rate was 12.8% and 14.6% in PCI and CABG patients, respectively (hazard ratio, 0.88 [95% confidence interval, 0.58–1.32]; P =0.53). Stroke was significantly increased in the CABG group (PCI 1.5% versus CABG 4.3%; hazard ratio, 0.33 [95% confidence interval, 0.12–0.92]; P =0.03) and repeat revascularization in the PCI arm (26.7% versus 15.5%; hazard ratio, 1.82 [95% confidence interval, 1.28–2.57]; P <0.01). Major adverse cardiac and cerebrovascular events were similar between arms in patients with low/intermediate SYNTAX scores but significantly increased in PCI patients with high scores (≥33). Conclusions— At 5 years, no difference in overall major adverse cardiac and cerebrovascular events was found between treatment groups. PCI-treated patients had a lower stroke but a higher revascularization rate versus CABG. These results suggest that both treatments are valid options for LM patients. The extent of disease should accounted for when choosing between surgery and PCI, because patients with high SYNTAX scores seem to benefit more from surgery compared with those in the lower tertiles. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00114972.
Time‐Trend Analysis on the Framingham Risk Score and Prevalence of Cardiovascular Risk Factors in Patients Undergoing Percutaneous Coronary Intervention Without Prior History of Coronary Vascular Disease Over the Last 17 Years: A Study From the Mayo Clinic

Clinical Cardiology | March 20, 2014 | Volume: 37 | Issue: 7 | Pages: 408-416

10.1002/clc.22274 | PMID 24652812

ABSTRACTBackgroundThere is a paucity of data on the temporal trends of cardiovascular risk factors in patients undergoing percutaneous coronary intervention (PCI). We investigated the secular trends of risk profiles of patients undergoing PCI without prior history of cardiovascular disease (CVD).HypothesisCVD risk factors are changed over time.MethodsThis time‐trend analysis from 1994 to 2010 was performed within the Mayo Clinic PCI Registry. Outcome measures were prevalence of CVD risk factors, including the Framingham risk score (FRS), at the time of admission for PCI.ResultsDuring this period, 12,055 patients without a history of CVD (mean age, 65.0 ± 12.4 years, 67% male) underwent PCI at the Mayo Clinic. Age distribution slightly shifted toward older age (P for trend <0.05), but sex did not change over time. Despite a higher prevalence of hypertension, hypercholesterolemia, and diabetes mellitus over time, actual blood pressure and lipid profiles improved (P for trend <0.001). Over time, FRS and 10‐year CVD risk improved significantly (7.3 ± 3.2 to 6.5 ± 3.3, P for trend <0.001; and 11.0 to 9.0, P for trend <0.001, respectively). Body mass index, not included in the FRS, increased significantly (29.0 ± 5.2 to 30.1 ± 6.2 kg/m2, P for trend <0.001), whereas smoking prevalence did not change.ConclusionsThe current study demonstrates that although traditional FRS and its associated predicted 10‐year cardiovascular risk declined over time, the prevalence of risk factors increased in patients undergoing PCI. The study suggests the need for a new risk‐factor assessment in this patient population.
Axillary Artery Conduit Formation for Arterial Access During Transapical Transcatheter Aortic Valve Replacement

Journal of Cardiac Surgery | March 19, 2014 | Volume: 29 | Issue: 3 | Pages: 308-311

10.1111/jocs.12326 | PMID 24641470