Transcatheter mitral valve in ring, hazards of long anterior mitral leaflet and 3-dimensional rings.

OBJECTIVES: The purpose of this study was to define anterior mitral leaflet (AML) length and mitral ring characteristics associated with LVOT obstruction and PVL following MViR. BACKGROUND: Transcatheter Mitral Valve in Ring (MViR) procedural complications including parvalvular leak (PVL) and left ventricular outflow tract (LVOT) obstruction are frequent. METHODS: Clinical records, computer tomographic scans (CTs) and echocardiograms of consecutive MViR patients were retrospectively reviewed for anterior mitral leaflet length, CT-simulated neoLVOT, and aortomitral angle among patients with and without MViR-induced LVOT obstruction. Acute and 1-year outcomes are described. RESULTS: Twenty-two patients underwent MViR. Technical success was achieved in 13/22 (57.1%) patients, limited by paravalvular regurgitation requiring second transcatheter heart valves (THVs) in seven patients. Second valves were needed in 6/11 (54.5%) patients with 3-dimensional rings but 1/11 (9.1%, p = .06) of patients with planar rings. Procedure success at 30 days was achieved in 20/22 (90.9%) patients. There were no procedural, in-hospital, or 30-day deaths. Two patients developed significant LVOT obstruction, one managed with urgent surgery and one with elective alcohol septal ablation. Anterior mitral leaflets were longer among the two patients with LVOT obstruction than the 20 patients who did not develop LVOT obstruction when measured by TEE (30 mm vs. 21 mm, p = .009) or by CT (29 mm vs. 22 mm, p = .026). CONCLUSIONS: AML >25 mm increases the risk of MViR induced LVOT obstruction. PVL is common, particularly in 3-dimensional rings which can be managed with a second THV.

Transcatheter Aortic Valve-in-Valve Replacement for Degenerated Stentless Bioprosthetic Aortic Valves: Results of a Multicenter Retrospective Analysis.

OBJECTIVES: The purpose of this study was to evaluate the safety and efficacy of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) for stentless bioprosthetic aortic valves (SBAVs) and to identify predictors of adverse events. BACKGROUND: ViV TAVR in SBAVs is associated with unique technical challenges and risks. METHODS: Clinical records and computer tomographic scans were retrospectively reviewed for procedural complications, predictors of coronary obstruction, mortality, and echocardiographic results. RESULTS: Among 66 SBAV patients undergoing ViV TAVR, mortality was 2 of 66 patients (3.0%) at 30 days and 5 of 52 patients (9.6%) at 1 year. At 1 year, left ventricular end-systolic dimension was decreased versus baseline (median [interquartile range (IQR)]: 3.0 [2.6 to 3.6] cm vs. 3.7 [3.2 to 4.4] cm; p < 0.001). Coronary occlusion in 6 of 66 procedures (9.1%) resulted in myocardial infarction in 2 of 66 procedures (3.0%). Predictors of coronary occlusion included subcoronary implant technique compared with full root replacement (6 of 31, 19.4% vs. 0 of 28, 0%; p = 0.01), short simulated radial valve-to-coronary distance (median [IQR]: 3.4 [0.0 to 4.6] mm vs. 4.6 [3.2 to 6.2] mm; p = 0.016), and low coronary height (7.8 [5.8 to 10.0] mm vs. 11.6 [8.7 to 13.9] mm; p = 0.003). Coronary arteries originated <10 mm above the valve leaflets in 34 of 97 unobstructed coronary arteries (35.1%). CONCLUSIONS: TAVR in SBAVs is frequently associated with high-risk coronary anatomy but can be performed with a low risk of death and myocardial infarction, resulting in favorable ventricular remodeling. A subcoronary surgical approach is associated with an increased risk of coronary obstruction.

The effect of postoperative medical treatment on left ventricular mass regression after aortic valve replacement.

OBJECTIVE: The study objective was to analyze factors associated with left ventricular mass regression in patients undergoing aortic valve replacement with a newer bioprosthesis, the Trifecta valve pericardial bioprosthesis (St Jude Medical Inc, St Paul, Minn). METHODS: A total of 444 patients underwent aortic valve replacement with the Trifecta bioprosthesis from 2007 to 2009 at 6 US institutions. The clinical and echocardiographic data of 200 of these patients who had left ventricular hypertrophy and follow-up studies 1 year postoperatively were reviewed and compared to analyze factors affecting left ventricular mass regression. RESULTS: Mean (standard deviation) age of the 200 study patients was 73 (9) years, 66% were men, and 92% had pure or predominant aortic valve stenosis. Complete left ventricular mass regression was observed in 102 patients (51%) by 1 year postoperatively. In univariate analysis, male sex, implantation of larger valves, larger left ventricular end-diastolic volume, and beta-blocker or calcium-channel blocker treatment at dismissal were significantly associated with complete mass regression. In the multivariate model, odds ratios (95% confidence intervals) indicated that male sex (3.38 [1.39-8.26]) and beta-blocker or calcium-channel blocker treatment at dismissal (3.41 [1.40-8.34]) were associated with increased probability of complete left ventricular mass regression. Patients with higher preoperative systolic blood pressure were less likely to have complete left ventricular mass regression (0.98 [0.97-0.99]). CONCLUSIONS: Among patients with left ventricular hypertrophy, postoperative treatment with beta-blockers or calcium-channel blockers may enhance mass regression. This highlights the need for close medical follow-up after operation. Labeled valve size was not predictive of left ventricular mass regression.

Black pigmented aortic valve and sinus of Valsalva caused by life-long minocycline therapy.

Minocycline, a derivative of tetracycline, is a broad-spectrum antibiotic used in the treatment of various infections. Black discolouration of the skin, teeth, bones and the thyroid gland are sequelae of long-term minocycline therapy. We report an unusual case of minocycline-induced pigmentation of the aortic valve and sinuses of Valsalva.

Patterns of anticoagulation following bioprosthetic valve implantation: observations from ANSWER.

BACKGROUND AND AIM OF THE STUDY: The American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommend a three-month administration of warfarin following bioprosthetic valve replacement (BVR). However, strong evidence supporting this recommendation is lacking, making process variation likely. METHODS: In the ANSWER Registry, a total of 386 patients who had received either Epic or Biocor BVRs between May 2007 and August 2008 at 40 centers was enrolled. Patterns of discharge anticoagulation and outpatient International Normalized Ratio (INR) values were collected. Mortality, embolic, and bleeding events were assessed up to six months after BVR. RESULTS: The median patient age was 74 years (interquartile range (IQR): 67-80 years), 39% of patients were female, and 65% were classified as a high thromboembolic risk. Warfarin was prescribed in 38% of all BVR patients, and in 49% of those at high risk of thromboembolism. The median time to therapeutic INR was nine days (IQR: 1 to 18 days), and 20% of patients failed to reach therapeutic levels. Among those patients achieving a therapeutic INR, 78% and 57% respectively had at least one subtherapeutic or supratherapeutic INR during the subsequent follow up to three months. During the follow up, patients treated with warfarin had similar rates of embolic events (2.8% versus 3.1%, p = 0.884), but a substantially higher incidence of bleeding than those not treated with warfarin (12% versus 3%, p = 0.0012). Among patients who were anticoagulated, those with supratherapeutic INR-values had a seven-fold higher risk for overt bleeding events (26% versus 3%). CONCLUSION: Anticoagulation strategies after BVR are highly variable. In this population, challenges in achieving and maintaining therapeutic warfarin anticoagulation are common, and are associated with an increased risk of bleeding. Further studies are required to clarify the optimal post-BVR anticoagulation strategy.

St Jude Medical Epic porcine bioprosthesis: results of the regulatory evaluation.

BACKGROUND: The St Jude Medical Epic heart valve (St Jude Medical, Inc, St Paul, Minn) is a tricomposite glutaraldehyde-preserved porcine bioprosthesis. The St Jude Medical Biocor porcine bioprosthesis is the precursor valve to the St Jude Medical Epic valve. The Epic valve is identical to the Biocor valve except that it is treated with Linx AC ethanol-based calcium mitigation therapy. METHODS: The St Jude Medical Epic valve was implanted in 761 patients (mean age 73.9 ± 9.2 years) between 2003 and 2006 in the US Food and Drug Administration regulatory study in 22 investigational centers. The position distribution was 557 aortic valve replacements, 175 mitral valve replacements, and 29 double valve replacements. Concomitant coronary artery bypass grafting was performed in 50.8% of patients undergoing aortic valve replacement and 36.6% of those undergoing mitral valve replacement. RESULTS: The early mortality was 3.6% in aortic and 2.3% in mitral valve replacement. The follow-up was 1675.5 patient-years with a mean of 2.2 ± 1.2 years/patient. Late mortality was 5.2%/patient-year in aortic and 6.6%/patient-year in mitral valve replacement. The late major thromboembolism rate was 0.98%/patient-year for aortic and 2.6%/patient-year for mitral valve replacement. There were 19 reoperations, including 2 for structural valve deterioration, 1 for thrombosis, 9 for nonstructural dysfunction, and 7 for prosthetic valve endocarditis. The actuarial freedom from reoperation owing to structural valve deterioration for aortic valve replacement at 4 years for age 60 years or less was 93.3% ± 6.4%; for ages 61 to 70 years, 98.1% ± 1.9%; and for older than 70 years, 100% (P = .0006 > 70 vs ≤ 60 years). There were no events of structural deterioration with mitral valve replacement. The actuarial freedom from major thromboembolism for all patients at 4 years was 93.6% ± 1.0%. The 2 cases of structural valve deterioration occurred in aortic valves that became perforated without calcification causing aortic regurgitation. CONCLUSIONS: The performance of the St Jude Medical Epic porcine bioprosthesis is satisfactory at 4 years for both aortic and mitral valve replacement. This study establishes the early clinical performance including durability of this porcine bioprosthesis.

Metal allergy to Amplatzer occluder device presented as severe bronchospasm.

Percutaneous closure of an atrial septal defect has become increasingly popular among interventional cardiologists. With this relatively new technology being more widespread, it is important to acknowledge any device-related complications. We report a case of severe bronchospasm secondary to a metal allergy after an atrial septal defect device closure requiring device removal.

Hyperglycemia predicts mortality after CABG: postoperative hyperglycemia predicts dramatic increases in mortality after coronary artery bypass graft surgery.

OBJECTIVE: Risk of morbidity and mortality after coronary artery bypass graft surgery (CABG) is higher in patients with clinical diabetes mellitus (DM). We evaluated whether outcomes are affected by postoperative hyperglycemia in CABG patients independent of preoperative DM diagnosis. RESEARCH DESIGN AND METHODS: A total of 2297 consecutive CABG patients were studied. The first glucose value after surgery completion (mean 15 min) was tested as a predictor of outcome. Primary outcome variables were prolonged ventilation (>24 h), deep sternal wound infection, renal failure, permanent stroke, any reoperation, length of stay (>14 days) and mortality. All outcomes except for prolonged ventilation and length of stay were tracked out to 30 days postoperatively. Patients were stratified by glycemic control: Low (glucose <80), normal (referent, glucose 80-110), high (glucose 111-200) and very high (glucose >200 mg/dl). Multivariable logistic regression was used to determine the independent predictive value of glycemic groups, adjusted for outcome specific risk scores from the Society of Thoracic Surgeons model. RESULTS: Patient distribution among groups low through very high were 44 (1.9%), 476 (20.7%), 1425 (62.0%) and 352 (15.3%). Greater complication rates were noted in the very high group when compared with the referent group: prolonged ventilation (adjusted odds ratio (OR)=2.66, P<.001), length of stay >14 days (adjusted OR=2.06, P=.004) and mortality (adjusted OR=7.71, P<.001). CONCLUSION: Patients with blood glucose values >200 mg/dl immediately after CABG had an increased risk of complications, including mortality, independent of a clinical diagnosis of DM. This study documents the high risk associated with early postoperative hyperglycemia in this group, suggesting the need for prospective trials of glycemic control.

Comparison of standard Maze III and radiofrequency Maze operations for treatment of atrial fibrillation.

OBJECTIVE: This study compares clinical results of the standard Maze III operation, a highly effective treatment for atrial fibrillation, to less complex variations of the Maze III operation utilizing unipolar and bipolar radiofrequency ablation and pulmonary vein isolation. METHODS: Records were reviewed of 377 patients who had operations for treatment of atrial fibrillation at a single institution over a 10-year period. Standard Maze III was performed in 220 patients, unipolar radiofrequency Maze III in 60, bipolar radiofrequency Maze III in 65, and radiofrequency pulmonary vein isolation in 32. Electrocardiograms were obtained at discharge and 3-, 6-, and 12-month intervals. Chi-square test, logistic regression, and Bayesian theory analyses were performed to determine significant associations between operative procedures and outcomes. RESULTS: Mean age was 65.1 years (range 22-87). There were 13 hospital deaths (3.4%) and 16 deaths during follow-up. Most patients (90.2%, 340/377) had concomitant operations. Electrocardiogram analysis was available in 344 patients at 3 months and 313 patients at 6 months. Freedom from atrial fibrillation at 6 months was superior after standard Maze III compared with radiofrequency modifications. Subanalysis according to surgeon experience demonstrated good results regardless of operative experience. CONCLUSIONS: This single-institution experience suggests that the standard Maze III operation is superior to radiofrequency operations for treatment of atrial fibrillation. Radiofrequency modifications of the Maze III operation are also effective treatments for atrial fibrillation and can achieve good results regardless of surgeon experience.

Multivariate predictors of heart transplantation outcomes in the era of chronic mechanical circulatory support.

BACKGROUND: Determining which pretransplantation (TX) characteristics predict the development of chronic renal dysfunction (CRD) or death after heart TX would enable more accurate risk assessment at the time of candidate evaluation. METHODS: A cohort of 278 patients underwent TX in three hospitals between 1993 and 2002. Predictive models for CRD (serum creatinine consistently above 2 mg/dL) and allograft loss (death or re-TX) were constructed using logistic and Cox regression, respectively. RESULTS: Using logistic regression, CRD was more likely to develop in TX patients if they had a larger body surface area (odds ratio [OR] = 5.8 per m2, 95% confidence interval [CI] = 1.04 to 31.9, p = 0.04) or were inotrope dependent (OR = 1.8, 95% CI = 0.90 to 3.7, p = 0.09). Notably, the implementation of mechanical circulatory support as bridge to transplantation decreased the risk of CRD (OR = 0.30, 95% CI = 0.12 to 0.72, p = 0.007). Cox analysis demonstrated independent predictive ability of improved survival for males (hazard ratio [HR] = 0.42, 95% CI = 0.21 to 0.83, p = 0.01). Worse survival was observed with prior sternotomy (HR = 3.5, 95% CI = 2.0 to 6.0, p < 0.001), diabetes mellitus (HR = 1.9, 95% CI = 0.98 to 3.9, p = 0.06), and elevated serum creatinine (HR = 2.8 per mg/dL, 95% CI = 1.3 to 5.8, p = 0.007). CONCLUSIONS: Certain pretransplant characteristics clearly predispose a patient to the development of CRD or increased mortality after heart transplantation. Interestingly, the risk of CRD after heart transplantation is greater for patients bridged to transplant with inotropes than with mechanical circulatory support. When hemodynamically indicated, timely implementation of pretransplant mechanical circulatory support should be considered.

Early postoperative use of unfractionated heparin or enoxaparin is associated with increased surgical re-exploration for bleeding.

BACKGROUND: A variety of indications (eg, prosthetic heart valves, atrial fibrillation, etc.) exist for the use of unfractionated heparin (UFH) and enoxaparin (ENOX) in the early postoperative period following open-heart surgery. However, the overall postoperative risk for hemorrhage from the use of UFH and ENOX are not known. METHODS: From 1998 to 2001, 2,977 consecutive open-heart or valve surgery patients were retrospectively evaluated. Postoperatively, 2,037 received no UFH or ENOX, 579 received intravenous UFH, and 361 received ENOX. Baseline characteristics were collected, patients who required surgical re-exploration for postoperative bleeding and time between surgery and re-exploration were followed-up. RESULTS: Average patient ages were 64 +/- 13, 65 +/- 12, and 68 +/- 10 years receiving none, UFH (p < 0.01 vs none), and ENOX (p < 0.01 vs none; p < 0.01 vs UFH), respectively. Rates of surgical re-exploration were 2.7% for none, 7.8% for UFH, and 8.9% for ENOX (vs none, adjusted hazard ratio = 2.8; p < 0.001 for UFH; hazard ratio = 3.3; p < 0.001 for ENOX). Males were also at higher risk for re-exploration (hazard ratio = 1.4; p = 0.07). For those requiring re-exploration, the interval between surgery and first re-exploration was prolonged (> 4 days) among those receiving ENOX (37.5%, odds ratio = 36.7; p = 0.001) and UFH (20.0%, odds ratio = 14.7; p = 0.01) compared with none (1.8%). Prolonged times with ENOX had a greater proportion of prolonged times than UFH (odds ratio = 2.5; p = 0.09). CONCLUSIONS: Early postoperative use of ENOX and UFH is associated with a significant increase in re-exploration for postoperative bleeding, often at a significantly delayed time period after the initial surgery. This delay was especially common with ENOX suggesting the need for prospective studies.

Preoperative use of enoxaparin compared with unfractionated heparin increases the incidence of re-exploration for postoperative bleeding after open-heart surgery in patients who present with an acute coronary syndrome: clinical investigation and reports.

BACKGROUND: Enoxaparin has become an attractive therapy for use during acute coronary syndrome (ACS) because of its potential superior efficacy over unfractionated heparin (UFH), its longer activity, and its subcutaneous route of administration. However, because a significant number of patients presenting with ACS may be sent directly to open heart surgery while still on anticoagulation, it is important to understand any potential bleeding risks that may be associated with the use of enoxaparin under these circumstances. METHODS: From 1998 to 2001, 1159 consecutive patients presenting with an acute coronary syndrome who received either UFH (n=1008) or enoxaparin (n=151) before proceeding to open heart surgery for urgent therapy during the same hospitalization were included in this study. Incidence of perioperative bleeding as evidenced by the units of blood products (packed red blood cells or platelets) transfused or the need for surgical re-exploration for postoperative bleeding was recorded. RESULTS: Average age was 65+/-11 and 67+/-11 years for patients receiving UFH and enoxaparin, respectively (P=0.005). Seventy-five percent of those receiving UFH and 64% of those receiving enoxaparin (P<0.005) were males. After discharge, the incidence of rehospitalization for hemorrhage requiring return to surgery for re-exploration was 7.9% in the enoxaparin group and 3.7% in the UFH group (adjusted hazard ratio=2.6, P=0.03). The use of blood products did not differ between groups (UFH=2.7+/-6.5 U and enoxaparin=2.3+/-4.5 U; P=NS). CONCLUSION: The preoperative use of enoxaparin compared with UFH in patients presenting with an ACS who undergo open-heart surgery during the same hospitalization is associated with a significantly increased incidence of re-exploration for postoperative bleeding. Further study is needed to understand the mechanism of this phenomenon and to develop appropriate guidelines to address this potentially important issue.

Repair of transverse sternal nonunions using metal plates and autogenous bone graft.

Transverse sternal nonunion is a complication of sternal fracture or partial sternotomy, and requires surgical treatment. Three patients with repeated failure of standard sternal repair were treated with a technique using metal plates and autogenous bone graft, which resulted in bone union in all patients. Metal plating of the sternum, accompanied by autogenous bone graft, is an effective method of treating transverse sternal nonunion.

Paravalvular leak and other events in silzone-coated mechanical heart valves: a report from AVERT.

BACKGROUND: The Artificial Valve Endocarditis Reduction Trial (AVERT) was designed to compare endocarditis rates in Silzone versus conventional valves. Recruitment ended January 21, 2000, because of higher rates of paravalvular leakage in patients receiving the Silzone prosthesis. The present analysis determined late event rates that might be used in the management of approximately 36,000 patients who have received the Silzone prosthesis. METHODS: A total of 807 patients in 19 centers in North America and Europe were randomized. Mean age was 61+/-11 years; 41% were women. Operations included aortic valve replacement in 59%, mitral valve replacement in 32%, and aortic and mitral valve replacements in 9%; 41% had concomitant operations (26% coronary artery bypass grafting). RESULTS: Major paravalvular leakage (followed by repair, explant, or mortality) occurred in 18 of 403 patients receiving Silzone valves and 4 of 404 patients without Silzone valves (2-year event-free rates: 91.1% versus 98.9% conventional, p < 0.003). Similarly, 2-year freedom from any explant was lower in the Silzone arm (19 versus 2 events; 90.1% versus 99.4%, p = 0.0002). Rates of mortality and stroke were similar during follow-up. CONCLUSIONS: Continued follow-up of AVERT supports the conclusion that the Silzone prosthesis has increased risk of paravalvular leakage requiring reoperation. Overall survival is similar in the two groups.