Aortic Root Thrombus Directly After Left Ventricular Assist Device Implantation.

A 70-year-old female heart failure patient could not be weaned from temporary left ventricular mechanical support with Impella CP (Abiomed Inc, Danvers, MA) after myocardial infarction; therefore, she underwent left ventricular assist device implantation (HeartMate 3; Abbott, Chicago, IL). After uneventful surgery, the patient had an early postoperative thrombus in the aortic root, and surgical thrombectomy on extracorporeal circulation was performed on the seventh postoperative day. The patient recovered well and presented in good condition with no neurologic symptoms at the 6-month follow-up visit. Surgical excision of aortic root thrombus is a feasible option even for frail patients with a left ventricular assist device.

Après un infarctus du myocarde, une patiente de 70 ans présentant une insuffisance cardiaque n'a pas pu être sevrée d'une assistance mécanique temporaire pour le ventricule gauche par dispositif Impella CP (Abiomed Inc, Danvers, MA); elle a donc subi l'implantation d'un dispositif d'assistance ventriculaire gauche (HeartMate 3; Abbott, Chicago, IL). Après une intervention sans incident, la patiente a présenté un thrombus postopératoire précoce dans l'anneau aortique, et une thrombectomie chirurgicale sous circulation extracorporelle a été réalisée le septième jour suivant l'intervention. La patiente s'est bien rétablie et semblait en bonne santé, sans symptômes neurologiques, au moment de la visite de suivi six mois plus tard. L'excision chirurgicale du thrombus de l'anneau aortique est une option réaliste même chez les patients fragiles ayant un dispositif d'assistance ventriculaire gauche.

Clinical criteria replenish high-sensitive troponin and inflammatory markers in the stratification of patients with suspected acute coronary syndrome.

OBJECTIVES: In patients with suspected acute coronary syndrome (ACS), rapid triage is essential. The aim of this study was to establish a tool for risk prediction of 30-day cardiac events (CE) on admission. 30-day cardiac events (CE) were defined as early coronary revascularization, subsequent myocardial infarction, or cardiovascular death within 30 days. METHODS AND RESULTS: This single-centre, prospective cohort study included 377 consecutive patients presenting to the emergency department with suspected ACS and for whom troponin T measurements were requested on clinical grounds. Fifteen biomarkers were analyzed in the admission sample, and clinical parameters were assessed by the TIMI risk score for unstable angina/Non-ST myocardial infarction and the GRACE risk score. Sixty-nine (18%) patients presented with and 308 (82%) without ST-elevations, respectively. Coronary angiography was performed in 165 (44%) patients with subsequent percutaneous coronary intervention--accounting for the majority of CE--in 123 (33%) patients, respectively. Eleven out of 15 biomarkers were elevated in patients with CE compared to those without. High-sensitive troponin T (hs-cTnT) was the best univariate biomarker to predict CE in Non-ST-elevation patients (AUC 0.80), but did not yield incremental information above clinical TIMI risk score (AUC 0.80 vs 0.82, p = 0.69). Equivalence testing of AUCs of risk models and non-inferiority testing demonstrated that the clinical TIMI risk score alone was non-inferior to its combination with hs-cTnT in predicting CE. CONCLUSIONS: In patients presenting without ST-elevations, identification of those prone to CE is best based on clinical assessment based on TIMI risk score criteria and hs-cTnT.

Evaluation of calcium loss after transcatheter aortic valve implantation.

OBJECTIVES: Aortic valve calcification and changes after transcatheter aortic valve implantation (TAVI) were specifically assessed by computed tomography (CT). The main difference between TAVI and the conventional technique is the compression of the cusps of the calcified native valve against the aortic wall before implantation. The objective of this study was to quantify the segmented calcification in the area of the basal annular plane before and after TAVI. METHODS: The CT scans of 20 patients (13 male and 7 female; mean age: 82.9 ± 8.1 years) were assessed. The aortic valve calcification was segmented; derived from this segmentation volume, mass and Hounsfield units (HU)/density of the calcifications on the annulus and cusps before and after TAVI were evaluated. Pre- and postoperative data were compared regarding potential calcification loss and calcification distances to the left and right coronary ostia. RESULTS: Significantly lower postprocedural mean volumes and masses for all cusps (P < 0.001) were found. The mean differences in the volume for the non-coronary, right-coronary and left-coronary cusp were -156.8 ± 53.73, -155.5 ± 62.54 and -115 ± 57.53 mm(3), respectively, and differences in mass were -88.78 ± 29.48, -95.2 ± 39.27 and -71.56 ± 35.62 mg, respectively. Over all cusps, mean HU increased after intervention [784.41 ± 92.5 HU (pre) and 818.63 ± 78.71 HU (post); P < 0.004]. In 80.03% of all cusps, calcification loss was found; all patients were affected. Significantly lower (P < 0.047) postprocedural mean distances were found from the left and right coronary ostia to the next calcification point. CONCLUSIONS: Our results show a significant loss of calcification in all patients after TAVI, with a reduction in the calcification distances to the coronary ostia and the compression of calcification in the area of the device landing zone. The clinical implications of this finding need to be investigated further.

Early and late mortality in patients undergoing transcatheter aortic valve implantation: comparison of the novel EuroScore II with established risk scores.

OBJECTIVES: In the evaluation of patients considered for transcatheter aortic valve implantation (TAVI), the EuroScore II might be superior to established risk scores. METHODS: We assessed the performance of the EuroScore II in predicting mortality in a cohort of 350 TAVI patients. RESULTS: The EuroScore II and the logistic EuroScore were higher in nonsurvivors compared to survivors at 30 days (12.6 ± 1.8 vs. 7.5 ± 0.3%, p < 0.001 for EuroScore II, and 27.7 ± 2.8 vs. 22.1 ± 0.8%, p = 0.04 for logistic EuroScore), while the STS-PROM score did not differ (7.3 ± 0.8 vs. 6.4 ± 0.3%, p = 0.09). The area under the curve (AUC) was 0.70 for the EuroScore II, 0.61 for the logistic EuroScore and 0.59 for the STS-PROM score for predicting 30-day mortality. Based on the estimated 30-day mortality risk, 3 risk groups were identified, a low-risk (EuroScore II ≤4%, 30-day mortality 1.2%), an intermediate-risk (EuroScore II between 4% and 9%, 30-day mortality 8.6%) and a high-risk group (EuroScore II >9%, 30-day mortality, 17.1%; p = 0.03). Regarding cumulative mortality, the AUC was 0.67 for the EuroScore II, 0.62 for the logistic EuroScore and 0.55 for the STS-PROM score for predicting mortality at total follow-up. CONCLUSIONS: In this patient cohort, the EuroScore II performed best in predicting short- and long-term mortality.

Altered activation of endothelial anti- and proapoptotic pathways by high-density lipoprotein from patients with coronary artery disease: role of high-density lipoprotein-proteome remodeling.

BACKGROUND: Endothelial dysfunction and injury are thought to play an important role in the progression of coronary artery disease (CAD). High-density lipoprotein from healthy subjects (HDL(Healthy)) has been proposed to exert endothelial antiapoptotic effects that may represent an important antiatherogenic property of the lipoprotein. The present study therefore aimed to compare effects of HDL(CAD) and HDL(Healthy) on the activation of endothelial anti- and proapoptotic pathways and to determine which changes of the lipoprotein are relevant for these processes. METHODS AND RESULTS: HDL was isolated from patients with stable CAD (HDL(sCAD)), an acute coronary syndrome (HDL(ACS)), and healthy subjects. HDL(Healthy) induced expression of the endothelial antiapoptotic Bcl-2 protein Bcl-xL and reduced endothelial cell apoptosis in vitro and in apolipoprotein E-deficient mice in vivo. In contrast, HDL(sCAD) and HDL(ACS) did not inhibit endothelial apoptosis, failed to activate endothelial Bcl-xL, and stimulated endothelial proapoptotic pathways, in particular, p38-mitogen-activated protein kinase-mediated activation of the proapoptotic Bcl-2 protein tBid. Endothelial antiapoptotic effects of HDL(Healthy) were observed after inhibition of endothelial nitric oxide synthase and after delipidation, but not completely mimicked by apolipoprotein A-I or reconstituted HDL, suggesting an important role of the HDL proteome. HDL proteomics analyses and subsequent validations and functional characterizations suggested a reduced clusterin and increased apolipoprotein C-III content of HDL(sCAD) and HDL(ACS) as mechanisms leading to altered effects on endothelial apoptosis. CONCLUSIONS: The present study demonstrates for the first time that HDL(CAD) does not activate endothelial antiapoptotic pathways, but rather stimulates potential endothelial proapoptotic pathways. HDL-proteome remodeling plays an important role for these altered functional properties of HDL. These findings provide novel insights into mechanisms leading to altered vascular effects of HDL in coronary disease.

Fractional flow reserve evaluation in patients considered for transfemoral transcatheter aortic valve implantation: a case series.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has become an established therapy for severe aortic stenosis (AS) in high-risk elderly individuals. Concomitant coronary artery disease (CAD) is frequently encountered in this patient population and may have an impact on outcomes. Hence, in patients with both severe AS and CAD, a bespoke therapy of both AS and/or CAD appears mandatory. METHODS: We report a series of 5 patients with severe AS and concomitant CAD considered for TAVI who underwent fractional flow reserve (FFR) for hemodynamic assessment of coronary lesions. RESULTS: In 3 patients, a 2-staged procedure was undertaken with FFR measurements at the time of invasive assessment and TAVI thereafter. In the remaining 2 patients, FFR measurements were performed immediately prior to the TAVI procedure with deferral of percutaneous coronary intervention (PCI) in one and ad hoc PCI in the other patient. All 5 patients had uneventful FFR measurements and procedural TAVI outcomes. One patient with a staged approach noted a significant improvement in symptoms already after PCI. CONCLUSIONS: FFR provides an effective and safe strategy to assess hemodynamic significance of coronary lesions in patients with severe AS and concomitant CAD considered for TAVI.

Assessment of inflammatory response to transfemoral transcatheter aortic valve implantation compared to transapical and surgical procedures: a pilot study.

AIMS: Surgical aortic valve replacement (AVR) has been associated with systemic inflammatory reactions. Yet, the role of inflammation following transcatheter aortic valve implantation (TAVI) has not been fully elucidated. METHODS AND RESULTS: In a total of 40 patients evaluated by the 'heart team,' this retrospective study assessed levels of high-sensitive C-reactive protein (hs-CRP) and leukocyte counts following 'uneventful' AVR and TAVI. Four groups of matched patients were compared (AVR; transapical and transfemoral Edwards SAPIEN [TA ES and TF ES, respectively]; and transfemoral Medtronic CoreValve [TF CV]). A postprocedural increase of both hs-CRP levels and leukocyte counts was observed (P<.001) with peak levels 48 hours after the procedures. Comparing treatment groups, hs-CRP levels at 48 hours were significantly higher following AVR and TA ES compared to TF ES and TF CV (P<.04). Leukocyte counts at 48 hours were higher following TA ES compared to TF ES and TF CV (P<.03). Multivariate analysis incorporating both hs-CRP levels and leukocyte counts confirmed significant differences for all measurements over time (P<.001). Furthermore, the treatment group significantly influenced postprocedural hs-CRP levels and leukocyte counts (P<.001). CONCLUSION: Both AVR and TAVI evoke a postprocedural inflammatory response. Higher hs-CRP levels and leukocyte counts following AVR and apical TAVI suggest less inflammation following femoral procedures.

Transcatheter aortic valve implantation (TAVI) outcome according to standardized endpoint definitions by the Valve Academic Research Consortium (VARC).

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become an accepted treatment option for severe aortic stenosis (AS) in high-risk individuals. Yet, current results are difficult to compare given the lack of standardized definitions. METHODS AND RESULTS: TAVI was performed in 130 high-risk individuals. The Edwards SAPIEN (n = 50) and the Medtronic CoreValve (n = 80) prostheses were implanted by transfemoral (75%) or transapical (25%) access. Outcomes at 30 days and 1 year are reported according to the newly established Valve Academic Research Consortium (VARC) criteria. Median follow-up was 235 days (range, 44-490 days). Thirty-day device success was high (91.5%). Combined safety endpoint at 30 days was 20.8%, with an all-cause mortality of 11.5%. Major vascular complications (11.5%), life-threatening or disabling bleeding (8.5%), and acute kidney injury (6.2%) were further major adverse events. At 1-year follow-up, valve performance was accurate in 94.7% of patients. However, prosthetic-valve associated complications, such as new left bundle branch block (20.0%) or permanent pacemaker implantation (34.7%), were common; cumulative prosthetic-valve associated complications were significantly more frequent in patients treated with a Medtronic CoreValve prosthesis (p = 0.0012). Overall 1-year survival was 80%, with the VARC combined efficacy endpoint (composite of survival, freedom from therapy failure, and accurate valve performance) met in 70.2%. In particular, at 1 year, 68.5% of the patients were living independently at home. CONCLUSION: The newly established VARC standardized definitions are useful for TAVI outcome reporting.

Myeloid related proteins activate Toll-like receptor 4 in human acute coronary syndromes.

INTRODUCTION: We previously reported increased expression of TLR4 on monocytes in thrombi from patients with acute coronary syndromes (ACS). In mice, myeloid related protein (MRP) 8 and MRP14, cytoplasmic proteins of neutrophils and monocytes, activate Toll-like receptor (TLR) 4 during sepsis. In human ACS, we investigated now whether the pro-inflammatory action of MRPs occurs through TLR4 in monocytes derived from thrombi. METHODS: Coronary thrombi and peripheral blood of 27 ACS patients were analyzed. CD14(+) monocytes were isolated and incubated with TLR2 ligand PM3SKA, TLR4 ligand lipopolysaccharide (LPS), MRP8, MRP14, or MRP8/14 heterocomplex. Anti-TLR4 antibodies (HTA125) were used to block TLR4 and polymyxin B (PMB) was employed to inhibit endotoxins. Before and after stimulation, the release of TNFα was measured by ELISA and the expression of TLR4 on CD14(+) monocytes was determined by flow cytometry. Further, selected pathways of downstream signaling were analyzed. RESULTS: MRP8 and MRP8/14 increased release of TNFα in cultures of CD14(+) monocytes, more in cells derived from thrombi compared with matched peripheral blood cells (p<0.001). LPS, MRP8, and MRP8/14, but much less PM3SKA and MRP14 alone, stimulated TNFα release, which can be inhibited by HTA125. MRP8/14 enhanced TLR4 expression on monocytes from thrombi (p<0.001), but not on monocytes from peripheral blood of the same patients. CONCLUSION: In ACS, MRP8 and MRP8/14 complex are specific ligands of TLR4, which induce the release of TNFα and probably other pro-inflammatory agents from monocytes. This specific MRP8/14-dependent pathway with striking similarities to sepsis increasing expression of TLR4 in thrombi appears to be involved in the pathogenesis of coronary occlusion and may represent a novel therapeutic target in ACS.

Cubic Hermite Bezier spline based reconstruction of implanted aortic valve stents from CT images.

Mechanical forces and strain induced by transcatheter aortic valve implantation are usually named as origins for postoperative left ventricular arrhythmia associated with the technique. No quantitative data has been published so far to substantiate this common belief. As a first step towards quantitative analysis of the biomechanic situation at the aortic root after transapical aortic valve implantation, we present a spline-based method for reconstruction of the implanted stent from CT images and for locally measuring the deformation of the stent.

Cellular actors, Toll-like receptors, and local cytokine profile in acute coronary syndromes.

AIMS: Inflammation plays a key role in acute coronary syndromes (ACS). Toll-like receptors (TLR) on leucocytes mediate inflammation and immune responses. We characterized leucocytes and TLR expression within coronary thrombi and compared cytokine levels from the site of coronary occlusion with aortic blood (AB) in ACS patients. METHODS AND RESULTS: In 18 ACS patients, thrombi were collected by aspiration during primary percutaneous coronary intervention. Thrombi and AB from these patients as well as AB from 10 age-matched controls without coronary artery disease were assessed by FACS analysis for cellular distribution and TLR expression. For further discrimination of ACS specificity, seven non-coronary intravascular thrombi and eight thrombi generated in vitro were analysed. In 17 additional patients, cytokine levels were determined in blood samples from the site of coronary occlusion under distal occlusion and compared with AB. In coronary thrombi from ACS, the percentage of monocytes related to the total leucocyte count was greater than in AB (47 vs. 20%, P = 0.0002). In thrombi, TLR-4 and TLR-2 were overexpressed on CD14-labelled monocytes, and TLR-2 was increased on CD66b-labelled granulocytes, in comparison with leucocytes in AB. In contrast, in vitro and non-coronary thrombi exhibited no overexpression of TLR-4. Local blood samples taken under distal occlusion revealed elevated concentrations of chemokines (IL-8, MCP-1, eotaxin, MIP-1alpha, and IP-10) and cytokines (IL-1ra, IL-6, IL-7, IL-12, IL-17, IFN-alpha, and granulocyte-macrophage colony-stimulating factor) regulating both innate and adaptive immunity (all P < 0.05). CONCLUSION: In ACS patients, monocytes accumulate within thrombi and specifically overexpress TLR-4. Together with the local expression patterns of chemokines and cytokines, the increase of TLR-4 reflects a concerted activation of this inflammatory pathway at the site of coronary occlusion in ACS.

Double transseptal puncture for catheter ablation of atrial fibrillation: safety of the technique and its use in the outpatient setting.

Introduction. For pulmonary vein isolation in patients with atrial fibrillation (AF), some centers use the double transseptal puncture technique for catheter access in order to facilitate catheter manipulation within the left atrium. However, no safety data has so far been published using this approach. Method. 269 ablation procedures were performed in 243 patients (mean age 56.6 ± 9.3 years, 75% men) using the double transseptal puncture for catheter access in all cases. Patients were considered for ablation of paroxysmal (80%), persistent (19%), and permanent (1%) AF. 230 procedures were performed on an outpatient basis (85.5%), and 26 were repeat procedures (9.7%). Results. The double transseptal puncture catheter access was successfully achieved in all patients. The procedural success with the endpoint of pulmonary vein isolation was reached in 255 procedures (95%). A total of 1048 out of 1062 pulmonary veins (99%) were successfully isolated. Major complications occurred in eight patients (3.0%). Of these, seven patients (2.6%) had pericardial effusion requiring percutaneous drainage, and one patient (0.4%) suffered a minor reversible stroke. One patient (0.4%) had a minor air embolism with transient symptoms. Conclusion. The double transseptal puncture catheterization technique allows easy catheter manipulation within the left atrium to reach the goal of acute procedural success in AF ablation. Procedure-related complications are rare, and the technique can be used safely for AF ablation in the outpatient setting.

Transcatheter aortic valve implantation: impact on clinical and valve-related outcomes.

BACKGROUND: Transcatheter aortic valve implantation is an alternative to open heart surgery in patients with aortic stenosis. However, long-term data on a programmatic approach to aortic valve implantation remain sparse. METHODS AND RESULTS: Transcatheter aortic valve implantation was performed in 168 patients (median age, 84 years) in the setting of severe aortic stenosis and high surgical risk. Access was transarterial (n=113) or, in the presence of small iliofemoral artery diameter, transapical (n=55). The overall success rate was 94.1% in this early experience. Intraprocedural mortality was 1.2%. Operative (30-day) mortality was 11.3%, lower in the transarterial group than the transapical group (8.0% versus 18.2%; P=0.07). Overall mortality fell from 14.3% in the initial half to 8.3% in the second half of the experience, from 12.3% to 3.6% (P=0.16) in transarterial patients and from 25% to 11.1% (P=0.30) in transapical patients. Functional class improved over the 1-year postprocedure period (P<0.001). Survival at 1 year was 74%. The bulk of late readmission and mortality was not procedure or valve related but rather was due to comorbidities. Paravalvular regurgitation was common but generally mild and remained stable at late follow-up. At a maximum of >3 years and a median of 221 days, structural valve failure was not observed. CONCLUSIONS: Transcatheter aortic valve implantation can result in early and sustained functional improvement in high-risk aortic stenosis patients. Late outcome is determined primarily by comorbidities unrelated to aortic valve disease.

A new transcatheter aortic valve and percutaneous valve delivery system.

OBJECTIVES: We describe procedural and clinical outcomes in a high-risk cohort undergoing transcatheter aortic valve replacement with early next-generation transcatheter valve and delivery systems. BACKGROUND: Percutaneous aortic valve replacement is gaining acceptance as a viable option in patients at high surgical risk. Broader application will require further advances in valve and delivery system technology. METHODS: Transarterial aortic valve replacement was attempted in 25 patients (mean age 85 years) determined to be at high surgical risk due to comorbidities. A new delivery catheter system (RetroFlex 2, Edwards Lifesciences, Irving, California) was utilized in combination with either a balloon-expandable SAPIEN (Edwards Lifesciences) valve or a next-generation low-profile cobalt-chromium bovine pericardial SAPIEN XT (Edwards Lifesciences) valve. RESULTS: Percutaneous valve replacement was successful in all 25 high-risk patients. Aortic valve area increased from 0.59 +/- 0.15 cm(2) to 1.60 +/- 0.27 cm(2). In this high-risk cohort (Society of Thoracic Surgeons and logistic EuroSCORE estimates of surgical mortality were 8.9% and 21.0%, respectively), 30-day mortality was 0%. CONCLUSIONS: Technical and procedural advances in catheter systems and prosthetic valves designed for percutaneous aortic valve delivery may contribute to increased procedural success and improved clinical outcomes.

Comparison of the hemodynamic performance of percutaneous and surgical bioprostheses for the treatment of severe aortic stenosis.

OBJECTIVES: This study was undertaken to compare the hemodynamic performance of a percutaneous bioprosthesis to that of surgically implanted (stented and stentless) bioprostheses for the treatment of severe aortic stenosis. METHODS: Fifty patients who underwent percutaneous aortic valve implantation (PAVI) with the Cribier-Edwards or Edwards SAPIEN bioprosthetic valve (Edwards Lifesciences, Inc., Irvine, California) were matched 1:1 for sex, aortic annulus diameter, left ventricular ejection fraction, body surface area, and body mass index, with 2 groups of 50 patients who underwent surgical aortic valve replacement (SAVR) with a stented valve (Edwards Perimount Magna [SAVR-ST group]), or a stentless valve (Medtronic Freestyle, Medtronic, Minneapolis, Minnesota [SAVR-SL group]). Doppler echocardiographic data were prospectively obtained before the intervention, at discharge, and at 6- to 12-month follow-up. RESULTS: Mean transprosthetic gradient at discharge was lower (p < 0.001) in the PAVI group (10 +/- 4 mm Hg) compared with the SAVR-ST (13 +/- 5 mm Hg) and SAVR-SL (14 +/- 6 mm Hg) groups. Aortic regurgitation (AR) occurred more frequently in the PAVI group (mild: 42%, moderate: 8%) compared with the SAVR-ST (mild: 10%, moderate: 0%) and SAVR-SL (mild: 12%, moderate: 0%) groups (p < 0.0001). At follow-up, the mean gradient in the PAVI group remained lower (p < 0.001) than that of the SAVR-ST group, but was similar to that of the SAVR-SL group. The incidence of severe prosthesis-patient mismatch was significantly lower (p = 0.007) in the PAVI group (6%) compared with the SAVR-ST (28%) and SAVR-SL (20%) groups. However, the incidence of AR remained higher (p < 0.0001) in the PAVI group compared with the 2 other groups. CONCLUSIONS: PAVI provided superior hemodynamic performance compared with the surgical bioprostheses in terms of transprosthetic gradient and prevention of severe prosthesis-patient mismatch, but was associated with a higher incidence of AR.

Transapical transcatheter aortic valve implantation: 1-year outcome in 26 patients.

BACKGROUND: We reported the first case of successful transapical transcatheter aortic valve implantation in a human subject in 2005 and have now completed a 12-month follow-up on our first 26 patients. This is, to date, the longest follow-up of patients undergoing transapical aortic valve implantation. METHODS: Between October 2005 and January 2007, 26 patients (13 female) underwent transcatheter transapical aortic valve implantation with either 23- or 26-mm Edwards Lifesciences transcatheter bioprostheses. All patients with symptomatic aortic stenosis were declined for conventional aortic valve replacement because of unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-up was performed before discharge and at 1, 6, and 12 months. Data from the 17 patients who survived over 12 months were used for comparisons of the baseline and follow-up results. RESULTS: The mean age was 80 +/- 9 years, and the predicted operative mortality was 37% +/- 20% by using logistic EuroSCORE and 11% +/- 6% by using the Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Six patients died within 30 days (30-day mortality, 23%), and 3 patients died from noncardiovascular causes after 30 days (late mortality, 12%). Among patients who survived at least 30 days, 12-month survival was 85%. There were no late valve-related complications. New York Heart Association functional class improved significantly. The aortic valve area and mean gradient remained stable at 12 months (1.6 +/- 0.3 cm(2) and 9.6 +/- 4.8 mm Hg, respectively). CONCLUSION: Our 1-year clinical and echocardiographic outcomes suggest that transapical transcatheter aortic valve implantation is a viable alternative to conventional aortic valve replacement in selected high-risk patients.