Two-dimensional transesophageal echocardiography for aortic annular sizing in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Accurate preoperative assessment of the aortic annulus dimension is crucial for successful transcatheter aortic valve implantation (TAVI). In this study we examined the accuracy of a novel method using two-dimensional transesophageal echocardiography (2D-TEE) for measurement of the aortic annulus. METHODS: We evaluated the theoretical impact of the measurement of the annulus diameter and area using the circumcircle of a triangle method on the decision to perform the procedure and choice of the prosthesis size. RESULTS: Sixty-three consecutive patients were scheduled for TAVI. Mean age was 82 ± 4 years, and 25 patients (55.6 %) were female. Mean aortic annulus diameter was 20.3 ± 2.2 mm assessed by TEE on the mid-esophageal long-axis view and 23.9 ± 2.3 mm using CT (p < 0.001). There was a tendency for the TEE derived areas using the new method to be higher (p < 0.001). The TEE measurements were on average 42.33 mm(2) higher than the CT measurements without an evidence of a systematic over- or under-sizing (p = 1.00). Agreement between TEE and CT chosen valve sizes was good overall (kappa = 0.67 and weighted kappa = 0.71). For patients who turned out to have no AR, the two methods agreed in 84.6 % of patients. CONCLUSIONS: CT remanis the gold standard in sizing of the aortic valve annulus. Nevertheless, sizing of the aortic valve annulus using TEE derived area may be helpful. The impact of integration of this method in the algorithm of aortic annulus sizing on the outcome of patients undergoing TAVI should be examined in future studies.

Feasibility of a new method using two-dimensional transesophageal echocardiography for aortic annular sizing in patients undergoing transcatheter aortic valve implantation; a case-control study.

BACKGROUND: Accurate preoperative assessment of the aortic annulus dimension is crucial for successful transcatheter aortic valve implantation (TAVI). In this study we validated a new method using two-dimensional transesophageal echocardiography (2D-TEE) for measurement of the aortic annulus prior to TAVI. METHODS: We analysed 124 patients who underwent successful TAVI using a self-expandable prosthesis, divided equally into two groups; in the study group we used the cross sectional short axis 2D-TEE for measurement of the aortic annulus and in the control group we used the long axis 2D-TEE. RESULTS: Both groups were comparable regarding the clinical parameters. On the other hand, patients in the study group had less left ventricular ejection fraction (38.9 % versus 45.6 %, p = 0.01). The aortic valve annulus was, although not statistically significant, smaller in the study group (21.58 versus 23.28 mm, p = 0.25). Post procedural quantification of the aortic regurgitation revealed that only one patient in both groups had severe aortic regurgitation (AR), in this patient the valve was implanted deep. The incidence of significant AR was higher in the control group (29.0 % versus 12.9 %, p = 0.027). CONCLUSIONS: Sizing of the aortic valve annulus using cross-sectional 2D-TEE offers a safe and plausible method for patients undergoing TAVI using the self-expandable prosthesis and is significantly superior to using long axis 2D-TEE.

Long-term clinical outcome of thin-strut cobalt-chromium stents in the drug-eluting stent era: results of the COBALT (comparison of bare-metal stents in all-comers' lesion treatment) registry.

BACKGROUND: Despite widespread penetration of drug-eluting stents (DES) in clinical practice, a relevant percentage of patients with coronary artery disease are still treated with bare-metal stents (BMS). Contemporary BMS, however, are less well investigated and comparative data on clinical outcome are lacking. METHODS AND RESULTS: This single-center registry aimed to assess characteristics and outcome of patients treated with 2 different new-generation cobalt-chromium BMS, the MULTI-LINK VISION and PRO-Kinetic stents. During the study, adopted criteria for BMS selection were: (1) limited compliance to dual antiplatelet therapy, (2) ST-elevation myocardial infarction (MI) or saphenous vein graft (SVG) interventions, and (3) noncomplex lesions located either in the right coronary artery or in the nonproximal segments of the left coronary artery. During a 24-month period 1,176 patients were treated with the VISION (n = 438) or PRO-Kinetic stent (n = 738). Median duration of follow-up was 549.5 and 528.5 days, respectively. Target lesion revascularization (TLR) and target vessel revascularization were numerically lower in the VISION group (10.4 vs. 12.3% and 11.9 vs. 15.2%, P = 0.24 and 0.11). Death (4.1 vs. 4.3%, P = 0.85), MI (2 vs. 2.3%, P = 0.78), and ARC definite stent thrombosis (0.5 vs. 0.5%, P = 0.84) were similar. By multivariate analysis, variables associated with TLR were SVG interventions (HR 2.21, 95% CI 1.26-3.86), total stent length (HR 1.01, 95% CI 1.00-1.02), and smoking (HR 1.51, 95% CI 1.05-2.16). CONCLUSION: In the DES era, the use of last-generation thin-strut BMS in selected patients is associated with acceptable clinical outcome, with similar clinical results for both the MULTI-LINK VISION and PRO-Kinetic stents.

Early hemodynamic and neurohormonal response after transcatheter aortic valve implantation.

BACKGROUND: The conventional surgical aortic bioprostheses used for treatment of aortic stenosis (AS) are inherently stenotic in nature. The more favorable mechanical profile of the Medtronic CoreValve bioprosthesis may translate into a better hemodynamic and neurohormonal response. PATIENTS AND METHODS: The early hemodynamic and neurohormonal responses of 56 patients who underwent successful transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve bioprosthesis for severe symptomatic AS were compared with those of 36 patients who underwent surgical aortic valve replacement (SAVR) using tissue valves in the same period. RESULTS: At baseline, patients in the TAVI and SAVR group had comparable indexed aortic valve area (0.33 ± 0.1 vs 0.34 ± 0.1 cm² , respectively; P = .69) and mean transvalvular gradient (51.1 ± 16.5 vs 53.1 ± 14.3 mm Hg, respectively; P = .56). At 30-day follow-up, mean transvalvular gradient was lower in the TAVI group than in the SAVR group (10.3 ± 4 vs 13.1 ± 6.2 mm Hg, respectively; P = .015), and the indexed aortic valve area was larger in the TAVI group (1.0 ± 0.14 vs 0.93 ± 0.13 cm²/m²; P = .017). There was a trend toward a higher incidence of moderate patient-prosthesis mismatch in the surgical group compared with the TAVI group (30.5% vs 17.8%, respectively; P = .11). The overall incidence of prosthetic regurgitation (any degree) was higher in the TAVI group than in the SAVR group (85.7% vs 16.7%, respectively; P < .00001). The left ventricular mass index decreased after TAVI (175.1 ± 61.8 vs 165.6 ± 57.2 g/m²; P = .0003) and remained unchanged after SAVR (165.1 ± 50.6 vs 161 ± 64.8 g/m²; P = .81). Similarly, NT-ProBNP decreased after TAVI (3,479 ± 2,716 vs 2,533 ± 1,849 pg/mL; P = .033) and remained unchanged after SAVR (1,836 ± 2,779 vs 1,689 ± 1,533 pg/mL; P = .78). There was a modest correlation between natriuretic peptides and left ventricular mass index in the whole cohort (r = 0.4, P = .013). CONCLUSION: In patients with severe AS, TAVI resulted in lower transvalvular gradients and higher valve areas than SAVR. Such hemodynamic performance after TAVI may have contributed to early initiation of a reverse cardiac remodeling process and a decrease in natriuretic peptides.

Successful percutaneous coronary intervention after implantation of a CoreValve percutaneous aortic valve.

BACKGROUND: The association between aortic valve disease and coronary atherosclerosis is common. In the recent era of percutaneous aortic valve replacement (PAVR), there is little experience with coronary artery intervention after valve implantation. CASE REPORT: To our knowledge, this is the first case of successful percutaneous coronary intervention after implantation of a CoreValve percutaneous aortic valve. We report a case of a 79-year-old female patient who underwent successful coronary artery intervention few months after a CoreValve's percutaneous implantation for severe aortic valve stenosis. Verifying the position of the used wires (crossing from inside the self expanding frame) is of utmost importance before proceeding to coronary intervention. In this case, crossing the aortic valve, coronary angiography, and multivessel stenting were successfully performed. CONCLUSION: Percutaneous coronary intervention in patients with previous CoreValve is feasible and safe.

Pooled analysis of percutaneous mitral valvuloplasty in Egypt.

BACKGROUND: Till now, no pooled analysis summarizing the Egyptian experience in percutaneous mitral valvuloplasty (PMV) exists. OBJECTIVES AND METHODS: To pool the data of PMV procedures and perform a new analysis regarding the immediate outcome and follow-up results as well as to compare the results of different techniques. RESULTS: Patients (2,256) with mitral stenosis of rheumatic origin were included, 292 males and 1,964 females. Double balloon (DB) was used in 1,148 patients (51%), Inoue balloon (IB) in 914 patients (40.5%), metallic commissurotome (MC) in 142 patients (6%), Multi-Track in 33 patients (1.5%), and single balloon in 19 patients (1%). The mitral valve area (MVA) increased from 0.94 +/- 0.18 cm2 to 1.92 +/- 0.36 cm2; mean pressure gradient dropped from 15.94 +/- 5.46 mmHg to 5.85 +/- 2.6 mmHg. The most common complication was the occurrence of a new mitral regurgitation (MR) and/or increase in its grade (36%). Inadequate dilatation occurred in 192 patients (8.5%). Follow-up data (for 5.7 +/- 5.9 months) showed that the immediate results of PMV on MVA persisted through the follow-up period (1.78 +/- 0.35 cm2). Multi-Track system resulted in the largest increase in MVA and also resulted in the largest immediate increase in the grade of MR. CONCLUSIONS: This study confirms the success of PMV and its results during follow-up. The Multi-Track system, and the DB resulted in the largest MVA, the IB and the single balloon resulted in the least increase in MR. The most common complication of PMV is the increase in the degree of MR.

Effect of gender differences on 1-year mortality after transcatheter aortic valve implantation for severe aortic stenosis: results from a multicenter real-world registry.

OBJECTIVES: The aim of this analysis is to examine the influence of gender differences on the outcome after transcatheter aortic valve implantation (TAVI) from a multicenter real-world registry in Germany (TAVI registry). BACKGROUND: The impact of gender differences on the clinical outcome after TAVI was examined in small studies with conflicting results. METHODS: Consecutive patients (n = 1,432) undergoing TAVI in the period between January 2009 and June 2010 in Germany were evaluated. Differences in all-cause mortality were examined with Kaplan-Meier estimates and proportional hazards models. RESULTS: Women comprised 57.8 % of the cohort. The Edwards Sapien valve (18.5 %) and CoreValve (81.5 %) were used through the transfemoral (87.7 %), subclavian (3.0 %), transapical (8.6 %), or transaortic approach (0.7 %). At baseline, women had higher aortic gradients and were older. Men had more comorbidities: prior myocardial infarction, prior revascularization, prior coronary artery bypass surgery, peripheral arterial vascular disease and chronic obstructive pulmonary disease. Women had more periprocedural vascular complications in comparison to men (25.2 vs. 17.2 %, p < 0.001). There was no significant difference in mortality at 30-day follow-up (7.6 % for women vs. 8.6 % for men, p = 0.55). The adjusted HR for 1-year all-cause mortality favored women, HR 0.75 (95 % CI 0.57-0.98, p = 0.0346) with a mortality rate of 17.3 vs. 23.6 % for men. CONCLUSIONS: Female gender is associated with better 1-year survival after TAVI. These results suggest that TAVI could be the best treatment modality for elderly women with symptomatic severe aortic stenosis.

Percutaneous left atrial appendage closure with a novel self-modelizing device: a pre-clinical feasibility study.

The aim of the study is to evaluate the feasibility and safety of a new left atrial appendage (LAA) occluder. Twelve pigs were included. In 2 pigs the implantation process failed due to pericardial tamponade in 1 pig and device embolization in the other pig. The placement of the devices was controlled via TEE and fluoroscopy. After 6 weeks of implantation the hearts were explanted. The devices were found to be easy to deploy and showed a very good adaptation to the LAA tissue. Eight out of 10 pigs had full closure of the LAA directly after implantation. After six weeks, due to the self-modelizing properties of the device, all pigs had a full closure of the LAA. The macroscopic evaluation of the explanted hearts showed that all devices were securely integrated in LAA tissues. There was one case of mild pericarditis but no macroscopic signs of inflammation on the device surrounding endocardium. The explantation revealed that device loops had penetrated the LAA tissue in three pigs. However, no signs of bleeding, pericardial effusion, or other damage to the LAA wall could be detected and the pigs were in good condition with normal weight gain and no clinical symptoms. The Occlutech® LAA occluder achieved complete closure of the LAA in all pigs, and remained in the LAA, with benign healing and no evidence of new thrombus or damage to surrounding structures. Moreover, the uncompromised survival of all implanted pigs demonstrates the feasibility and safety of the device.

Haemodynamic evaluation of aortic regurgitation after transcatheter aortic valve implantation using cardiovascular magnetic resonance.

AIMS: Echocardiography may underestimate the degree of paravalvular aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve bioprosthesis due to inherent limitations of ultrasound imaging in the evaluation of implanted cardiac prostheses. We aimed to evaluate the accuracy and feasibility of cardiovascular magnetic resonance (CMR) in quantifying regurgitant volume (RV) and regurgitant fraction (RF) in patients treated with this bioprosthesis for severe calcific aortic stenosis, and to compare the results with echocardiography and aortography. METHODS AND RESULTS: This study included 16 patients with a mean age of 78.7 years (eight women, eight men) who underwent successful TAVI using Medtronic CoreValve bioprosthesis. AR was evaluated by CMR, echocardiography, and aortography. Angiography was performed immediately after valve implantation. CMR and echocardiography were performed four weeks after valve implantation. There was a highly significant correlation between the CMR-derived and the angiographically-estimated degree of AR (r=0.86, p<0.001). On the other hand, there was only a limited correlation between CMR and echocardiography (r=0.374, p=0.15) as well as angiography and echocardiography (r=0.319, p=0.23) regarding the degree of AR. The weighted kappa for agreement between echocardiography and angiography was 0.14, for agreement between echocardiography and CMR 0.20, and for agreement between angiography and CMR 0.72. Echocardiography underestimated AR by one degree compared to CMR in five patients and 2 degrees in two patients; in six of these, the degree of AR obtained by CMR was similar to angiography. CONCLUSIONS: In patients undergoing TAVI, comparisons between purely quantitative measurements of AR by CMR and qualitative assessment by angiography showed better correlations than those with echocardiography. This suggests that echocardiography may underestimate the degree of AR and CMR in these circumstances has a great potential in reliably measuring the severity of AR in a quantitative manner.

Clinical and hemodynamic predictors of natriuretic peptide elevation among aortic valve disease patients.

We investigated the relative contribution of hemodynamic and clinical factors to serum natriuretic peptide elevation in seventy-one patients with either aortic stenosis or aortic regurgitation. We found that pulmonary hypertension, heart failure and renal failure are the most powerful independent predictors of natriuretic peptide elevation in patients with aortic valve disease, irrespective of the type or severity of valvular lesion itself.

Impact of smoking on the outcome of patients treated with drug-eluting stents: 1-year results from the prospective multicentre German Drug-Eluting Stent Registry (DES.DE).

BACKGROUND: Cigarette smoking strongly increases morbidity and mortality from cardiovascular causes, but the relevance of smoking in patients treated with drug-eluting stents (DES) is unknown. AIMS: To assess the impact of smoking on the presentation and outcome of patients treated with DES. METHODS AND RESULTS: We analyzed data from the prospective multicentre German Drug-Eluting Stent Registry (DES.DE) and identified 1,122 patients who had never smoked and 1,052 patients who were current smokers. Smokers were younger (56.5 vs. 69.4 years, p < 0.0001), more often males, with less frequent diabetes and hypertension compared to non-smokers. Smokers presented more often with acute coronary syndromes. After a mean follow-up of 12.5 months, smokers had both higher mortality (4.6 vs. 2.7%, p < 0.05) and myocardial infarction (MI) rates (4.9 vs. 3%, p < 0.01). There was no significant difference between smokers and non-smokers in the rate of target vessel revascularization (9.8 vs. 11.4%, p = 0.26). Major adverse cardiac and cerebrovascular events (defined as the composite of death, MI and stroke, MACCE) were higher in smokers (10.6 vs. 6.1%, p < 0.001). Moreover, after adjustment for baseline clinical and angiographic variables, smoking continued to be a strong independent predictor for MACCE (OR = 2.34, 95% CI 1.49-3.68). In a subgroup analysis, we found that the increased risk of smoking was most prominent in patients presenting with stable angina pectoris (OR = 3.71, 95% CI 1.24-2.57, p < 0.05). Smoking almost doubled the risk for MACCE in acute MI patients, though this did not reach statistical significance (adjusted OR = 1.91, 95% CI 0.93-3.94, p = 0.74). CONCLUSION: This large multicentre DES registry provides evidence that smokers treated with DES, despite lower incidence of predisposing risk factors for atherosclerosis, experience higher rates of death and MI compared to non-smokers, particularly in the setting of stable coronary artery disease. Smoking has only marginal effects on target vessel revascularization rates in patients treated with DES.

Comparison of hospital mortality with intra-aortic balloon counterpulsation insertion before versus after primary percutaneous coronary intervention for cardiogenic shock complicating acute myocardial infarction.

Primary percutaneous coronary intervention (PCI) and intra-aortic balloon pump counterpulsation (IABP) are established treatment modalities in acute myocardial infarction complicated by cardiogenic shock. We hypothesized that the insertion of the IABP before primary PCI might result in better survival of patients with cardiogenic shock compared to postponing the insertion to after primary PCI. We, therefore, retrospectively studied 48 patients who had undergone primary PCI with IABP because of cardiogenic shock complicating acute myocardial infarction (26 patients received the IABP before and 22 patients after primary PCI). No significant differences were present in the baseline clinical characteristics between the 2 groups. The mean number of diseased vessels was greater in the group of patients treated with the IABP before primary PCI (2.8 +/- 0.5 vs 2.3 +/- 0.7, p = 0.012), but the difference in the number of treated vessels was not significant. The peak creatine kinase and creatine kinase -MB levels were lower in patients treated with the IABP before primary PCI (median 1,077, interquartile range 438 to 2067 vs median 3,299, interquartile range 695 to 6,834, p = 0.047, and median 95, interquartile range 34 to 196 vs median 192, interquartile range 82 to 467, p = 0.048, respectively). In-hospital mortality and the overall incidence of major adverse cardiac and cerebrovascular events were significantly lower in the group of patients receiving the IABP before primary PCI (19% vs 59% and 23% vs 77%, p = 0.007 and p = 0.0004, respectively). Multivariate analysis identified renal failure (odds ratio 15.2, 95% confidence interval 3.13 to 73.66) and insertion of the IABP after PCI (odds ratio 5.2, 95% confidence interval 1.09 to 24.76) as the only independent predictors of in-hospital mortality. In conclusion, the results of the present study suggest that patients with cardiogenic shock complicating acute myocardial infarction who undergo primary PCI assisted by IABP have a more favorable in-hospital outcome and lower in-hospital mortality than patients who receive IABP after PCI.

Anatomic and procedural predictors of paravalvular aortic regurgitation after implantation of the Medtronic CoreValve bioprosthesis.

OBJECTIVES: The purpose of this study was to determine the predictors of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI). BACKGROUND: TAVI has been associated with a high rate of paravalvular regurgitation, usually mild. Nevertheless, moderate to severe regurgitations still occur and may have negative clinical consequences. METHODS: Fifty patients with severe aortic stenosis were recruited and underwent successful TAVI with the Medtronic CoreValve bioprosthesis through the transfemoral route. The end point of this study is the early occurrence of significant AR, defined as the occurrence of grade II or more AR by post-procedural aortography. RESULTS: The study population's mean age was 80.5 ± 7.9 years, with a mean aortic valve area of 0.64 ± 0.17 cm². Post-procedural AR was absent in 3 patients and was grade I in 27 patients, grade II in 13 patients, and grade III in 7 patients. Using univariate analysis, the chance of significant AR increased with increasing angle of left ventricular outflow tract to ascending aorta (∠LVOT-AO) (odds ratio: 1.24, p < 0.001). For the depth of the device in relation to the noncoronary cusp, there was a minimum chance of AR corresponding to depth = 9.5 mm (odds ratio: 1.1, p = 0.01). Using multivariate analysis, we found a greater chance of significant AR with a greater angle (odds ratio: 1.24, p = 0.001), and that the chance of significant AR is a minimum when depth of the device in relation to the noncoronary cusp is ∼10 mm (odds ratio: 1.1, p = 0.024). A predictive model was generated, and if 2 ×∠LVOT-AO + (depth to noncoronary cusp - 10)² ≥ 50, the likelihood of occurrence of significant AR could be predicted with a sensitivity of 85% and a specificity of 87%. CONCLUSIONS: The occurrence of significant AR after TAVI can be predicted by anatomic and procedural variables. A model such as that presented can be used to select suitable patients for this procedure and guide operators during implantation of the device.