Transcatheter aortic valve replacement in patients with severe mitral or tricuspid regurgitation at extreme risk for surgery.

OBJECTIVES: Patients with symptomatic severe aortic stenosis and severe mitral regurgitation or severe tricuspid regurgitation were excluded from the major transcatheter aortic valve replacement trials. We studied these 2 subgroups in patients at extreme risk for surgery in the prospective, nonrandomized, single-arm CoreValve US Expanded Use Study. METHODS: The primary end point was all-cause mortality or major stroke at 1 year. A favorable medical benefit was defined as a Kansas City Cardiomyopathy Questionnaire overall summary score greater than 45 at 6 months and greater than 60 at 1 year and with a less than 10-point decrease from baseline. RESULTS: There were 53 patients in each group. Baseline characteristics for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were age 84.2 ± 6.4 years and 84.9 ± 6.5 years; male, 29 (54.7%) and 22 (41.5%), and mean Society of Thoracic Surgeons score 9.9% ± 5.0% and 9.2% ± 4.0%, respectively. Improvement in valve regurgitation from baseline to 1 year occurred in 72.7% of the patients with severe mitral regurgitation and in 61.8% of patients with severe tricuspid regurgitation. A favorable medical benefit occurred in 31 of 47 patients (66.0%) with severe mitral regurgitation and 33 of 47 patients (70.2%) with severe tricuspid regurgitation at 6 months, and in 25 of 44 patients (56.8%) with severe mitral regurgitation and 24 of 45 patients (53.3%) with severe tricuspid regurgitation at 1 year. All-cause mortality or major stroke for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were 11.3% and 3.8% at 30 days and 21.0% and 19.2% at 1 year, respectively. There were no major strokes in either group at 1 year. CONCLUSIONS: Transcatheter aortic valve replacement in patients with severe mitral regurgitation or severe tricuspid regurgitation is reasonable and safe and leads to improvement in atrioventricular valve regurgitation.

1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses.

OBJECTIVES: This study evaluated the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF). BACKGROUND: Self-expanding TAVR is superior to medical therapy for patients with severe native aortic valve stenosis at increased surgical risk. METHODS: The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation. RESULTS: SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p < 0.001). CONCLUSIONS: Self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality and major stroke rate, significantly improved aortic valve hemodynamics, and low rates of moderate and no severe residual aortic regurgitation, with improved quality of life.

Neurological Events Following Transcatheter Aortic Valve Replacement and Their Predictors: A Report From the CoreValve Trials.

BACKGROUND: The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. Identification of predictors for stroke is likely to be a critical factor aiding patient selection and management as TAVR use becomes widespread. METHODS AND RESULTS: Patients enrolled in the CoreValve US Extreme Risk and High Risk Pivotal Trials or Continued Access Study treated with the self-expanding CoreValve bioprosthesis were included in this analysis. The 1-year stroke rate after TAVR was 8.4%. Analysis of the stroke hazard rate identified an early phase (0-10 days; 4.1% of strokes) and a late phase (11-365 days; 4.3% of strokes). Baseline predictors of early stroke included National Institutes of Health stroke scale score >0, prior stroke, prior transient ischemic attack, peripheral vascular disease, absence of prior coronary artery bypass surgery, angina, low body mass index (<21 kg/m(2)), and falls within the past 6 months. Significant procedural predictors were total time in the catheterization laboratory or operating room, delivery catheter in the body time, rapid pacing used during valvuloplasty, and repositioning of the prosthesis. Predictors of stroke between 11 and 365 days were small body surface area, severe aortic calcification, and falls within the past 6 months. There were no significant imaging predictors of early or late stroke. CONCLUSIONS: Predictors of early stroke after TAVR included clinical and procedural factors; predictors of later stroke were limited to patient but not anatomic characteristics. These findings indicate that further refinement of imaging to identify anatomic factors predisposing to embolization may help improve stroke prediction in patients undergoing TAVR. CLINICAL TRIAL REGISTRATIONS: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01240902, NCT01531374.

Surgical repair of a left atrial-esophageal fistula after radiofrequency catheter ablation for atrial fibrillation.

Left atrial-esophageal fistula is a highly lethal complication of ablative therapy for atrial fibrillation. Because of its unusual rate of occurrence, there has not been a uniform approach to either the diagnosis or corrective therapy. We offer 1 such surgical option based on presumptive and early diagnosis-left atrial repair with cardiopulmonary bypass followed by repair of the esophagus with an omental wrap and supported with decompressive gastrostomy and feeding jejunostomy.

Left circumflex coronary artery occlusion after mitral valve annuloplasty: "a stitch in time".

The left circumflex coronary artery is susceptible to injury during mitral valve surgery because of its proximity to the mitral valve annulus. We report the case of a 73-year-old woman who had undergone mitral valve repair and experienced a perioperative myocardial infarction due to occlusion of the left circumflex coronary artery. After percutaneous coronary intervention, a fistulous communication had developed between the stented portion of the left circumflex coronary artery and the left atrium, which, to our knowledge, is the first report of such a complication. The patient underwent successful mitral valve replacement. Although injuries to the left circumflex coronary artery are rare during mitral valve surgery, we believe that increasing awareness of the risk will help to prevent potentially fatal complications. We also recommend that surgeons gather as much detail as possible about the patient's anatomy before operation, use careful and meticulous surgical techniques, and use transesophageal echocardiography to look for wall-motion abnormalities before closing the incision.

Drug-eluting versus bare-metal stents in the treatment of patients with ST-segment elevation myocardial infarction.

OBJECTIVES: The purpose of this study was to compare outcomes for drug-eluting stents (DES) and bare-metal stents (BMS) for patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Despite some controversy related to late stent thromboses, DES are approved for use in many patients undergoing stenting. However, there are several types of patients in whom implanting a DES would be regarded as off-label use, and this study compares DES and BMS for one of these groups. METHODS: New York's percutaneous coronary intervention registry was used to identify 772 patients undergoing percutaneous coronary intervention (PCI) for STEMI who received BMS and 1,154 STEMI patients who received DES between October 1, 2003, and December 31, 2004. These patients were tracked through December 31, 2005. Mortality, target vessel PCI, and subsequent coronary artery bypass graft (CABG) surgery within 2 years of undergoing the procedure were captured. Adverse outcomes were adjusted using proportional hazards methods to account for baseline differences in patients' severity of illness. RESULTS: The BMS patients had significantly higher mortality (adjusted hazard ratio [HR] vs. DES = 2.01, 95% confidence interval [CI] 1.21 to 3.34, risk-adjusted mortality = 8.6% vs. 5.0%, p = 0.007) and significantly higher subsequent CABG surgery (adjusted HR vs. DES = 2.33, 95% CI 1.31 to 4.16, risk-adjusted rate = 6.4% vs. 3.0%, p = 0.004) rates. There was no difference by type of DES (adjusted HR for paclitaxel-eluting stent versus sirolimus-eluting stent; mortality 0.72, 95% CI 0.30 to 1.72), subsequent CABG surgery (adjusted HR = 0.60, 95% CI 0.26 to 1.40), and target vessel PCI (adjusted HR = 0.74, 95% CI 0.35 to 1.58). CONCLUSIONS: In this observational study, DES were associated with lower mortality and subsequent CABG surgery when used for STEMI patients.

Value of electrocardiographically gated single-photon emission computed tomographic myocardial perfusion scintigraphy in a cohort of symptomatic postmenopausal women.

The aim of this study is to prospectively evaluate the clinical value of electrocardiographically gated single-photon emission computed tomographic myocardial perfusion scintigraphy (MPS) imaging in a cohort of postmenopausal women with symptoms suggestive of ischemic heart disease. Forty-six postmenopausal women with no history of coronary artery disease (CAD), but with typical or atypical angina and >or=1 risk factor for CAD, were enrolled and underwent both coronary angiography and technetium-99m sestamibi MPS with exercise (n = 36) or pharmacologic stress (n = 10). All women were followed up for 5.0 +/- 3 years for the occurrence of hospitalization for acute coronary syndrome, myocardial infarction, and/or new-onset or worsening angina. CAD prevalence (>or=50% diameter stenosis) was 62% (26 of 42 patients). Fifteen patients (36%) had 1-vessel disease, 7 (17%) had 2-vessel disease, and 4 (10%) had 3-vessel disease. Diagnostic sensitivity and specificity of the exercise electrocardiogram were 67% and 69%, respectively. By comparison, sensitivity of MPS was 88% and specificity was 87.5% (p <0.0001). Cox survival analysis showed 3- and 5-year cumulative event-free survival rates of 97% and 94% for patients with normal MPS results compared with 60% and 48% for those with abnormal MPS findings (p <0.001). In conclusion, results of this study indicate high diagnostic and prognostic accuracy for MPS in symptomatic postmenopausal women.

Development of in vitro antimicrobial resistance in bacteria exposed to residue level exposures of antimicrobial drugs, pesticides and veterinary drugs.

Ten ppb or less of antibacterial drugs, pesticides and veterinary drugs could increase antibacterial resistance in bacteria. The minimum inhibitory concentration (MIC) was the indicator of resistance and Staphylococcus aureus ATCC 9144 the indicator organism. Seventeen compounds used in human, veterinary medicine, crop production, and found in the environment, were studied singly, and as combinations. Single compounds decreased MIC values in 5.3% of possibilities; showed no changes in 74.4% of values; increased values in 21.8%; 16.5% of MICs increased 4- to 8-fold; 4.7% of changes were >8-fold. For two-compound mixtures 5.1% of MICs showed no changes; 34.3% increased 4-8 times; 60.6% increased >8-fold. For six-compound combinations: 5.9% of MICs showed no changes; 15.6% increased 4- to 8-fold; 78.5% increased >8-fold.

Impact of completeness of percutaneous coronary intervention revascularization on long-term outcomes in the stent era.

BACKGROUND: The importance of completeness of revascularization by percutaneous coronary intervention in patients with multivessel disease is unclear in that there is little information on the impact of incomplete revascularization outside of randomized trials. The objective of this study is to compare long-term mortality and subsequent revascularization for percutaneous coronary intervention patients receiving stents who were completely revascularized (CR) with those who were incompletely revascularized (IR). METHODS AND RESULTS: Patients from New York State's Percutaneous Coronary Interventions Reporting System were subdivided into patients who were CR and IR. Then subsets of IR patients were contrasted with CR patients. Differences in long-term survival and subsequent revascularization for CR and IR patients were compared after adjustment for differences in preprocedural risk. A total of 68.9% of all stent patients with multivessel disease who were studied were IR, and 30.1% of all patients had total occlusions and/or > or =2 IR vessels. At baseline, the following patients were at higher risk: those who were older and those with more comorbid conditions, worse ejection fraction, and more renal disease and stroke. After adjustment for these baseline differences, IR patients were significantly more likely to die at any time (adjusted hazard ratio=1.15; 95% confidence interval, 1.01 to 1.30) than CR patients. IR patients with total occlusions and a total of > or =2 IR vessels were at the highest risk compared with CR patients (hazard ratio=1.36; 95% confidence interval, 1.12 to 1.66). CONCLUSIONS: IR with stenting is associated with an adverse impact on long-term mortality, and consideration should be given to either achieving CR, opting for surgery, or monitoring percutaneous coronary intervention patients with IR more closely after discharge.

Volume-outcome relationships for percutaneous coronary interventions in the stent era.

BACKGROUND: Most studies that are the basis of recommended volume thresholds for percutaneous coronary interventions (PCIs) predate the routine use of stent placement. METHODS AND RESULTS: Data from New York's Percutaneous Coronary Interventions Reporting System in 1998 to 2000 (n=107 713) were used to examine the impact of annual hospital volume and annual operator volume on in-hospital mortality, same-day coronary artery bypass graft (CABG) surgery, and same-stay CABG surgery after adjustment for differences in patients' severity of illness. For a hospital-volume threshold of 400, the odds ratios for low-volume hospitals versus high-volume hospitals were 1.98 (95% CI, 1.17, 3.35) for in-hospital mortality, 2.07 (95% CI, 1.36, 3.15) for same-day CABG surgery, and 1.51 (95% CI, 1.03, 2.21) for same-stay CABG surgery. For an operator-volume threshold of 75, the odds ratios for low-volume versus high-volume operators were 1.65 (95% CI, 1.05, 2.60) for same-day CABG surgery and 1.55 (95% CI, 1.10, 2.18) for same-stay CABG surgery. Operator volume was not significantly associated with mortality. Also, for hospital volumes below 400 and operator volumes below 75, the respective odds of mortality, same-day CABG surgery, and same-stay CABG surgery were 5.92, 4.02, and 3.92 times the odds for hospital volumes of 400 or higher and operator volumes of 75 or higher. CONCLUSIONS: Higher-volume operators and hospitals continue to experience lower risk-adjusted PCI outcome rates.

Outcomes of paclitaxel-eluting stent implantation in patients with stenosis of the left anterior descending coronary artery.

OBJECTIVES: We sought to examine the efficacy of paclitaxel-eluting stent implantation in the left anterior descending coronary artery (LAD). BACKGROUND: Restenosis and recurrent cardiac events after percutaneous intervention are more common for lesions in the LAD than other native coronary arteries, and often necessitate bypass surgery. Drug-eluting stents may improve the long-term prognosis of this high-risk group. METHODS: In the TAXUS-IV trial, 1,314 patients with single de novo coronary lesions were assigned to implantation of the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or an identical bare-metal stent; 536 (41%) randomized patients had LAD lesions. RESULTS: Baseline characteristics of patients with LAD lesions were well-matched between the randomized groups. Late lumen loss at nine months after paclitaxel-eluting and control stent implantation were 0.28 +/- 0.51 mm and 0.54 +/- 0.57 mm, respectively (p = 0.0004), and binary restenosis rates were 11.3% and 26.9%, respectively (p = 0.004). At one year, major adverse cardiac events (MACE) occurred in 13.5% of TAXUS-treated patients versus 21.2% treated with the control stent (p = 0.01). The need for bypass surgery at one year was reduced among patients randomized to the TAXUS stent (2.6% vs. 6.3%, p = 0.02). In the proximal LAD subgroup (n = 126), the one-year target vessel revascularization rate was 7.9% with the TAXUS stent and 18.6% with the bare-metal stent (p = 0.009). CONCLUSIONS: Compared to bare-metal stents, implantation of polymer-based, paclitaxel-eluting stents in LAD lesions is safe, and reduces angiographic restenosis and MACE one year. Notably, the need for bypass graft surgery due to restenosis is reduced after TAXUS stent implantation in LAD lesions.

In Vitro Enhancement of Antibiotic Resistance Development-Interaction of Residue Levels of Pesticides and Antibiotics †.

This study investigated the interaction of three commonly used pesticides, carbaryl, captan, and malathion, with combinations of antibiotics occurring commonly in milk, all at levels below established tolerances. The modality of measurement was the MIC; the assay organism was Staphylococcus aureus ATCC 9144. Acetone alone or individual pesticides in acetone caused no increase in the baseline MIC of any of the marker antibiotics. For single antibiotics, (ampicillin, dihydrostreptomycin, erythromycin, neomycin, oxytetracycline, and sulfamethazine) 7.1 % of the combination possibilities showed increased MICs. The three pesticides together resulted in an increased MIC in 4.8% of the combinations. Varying combinations of three of the aforelisted antibiotics showed increases in the baseline MIC in 18.5% of the possibilities. Combinations of three antibiotics and the three pesticides showed increased MICs in 24.4% of the possibilities. There appears to be an additive effect upon the development of antibiotic resistance of S. aureus cells between the three pesticides and the antibiotics in the combinations studied.