BACKGROUND:Transcatheter aortic valve implantation (TAVI) is an alternative treatment of severe symptomatic aortic stenosis (AS) in patients with high operative risk. In spite of favorable entire results, long-term mortality of patients is high. HYPOTHESIS:The present study aims to identify independent preprocedural risk factors to improve risk stratification in these highly selected patients. METHODS:This prospective study included 202 consecutive patients with severe symptomatic AS and high operative risk (mean logistic European System for Cardiac Operative Risk Evaluation, 22±17%; mean age, 79±6 years; 107 female). Preprocedural comprehensive examinations were performed (laboratory, electrocardiography, echocardiography, cardiac catheterization). All patients received transfemoral or transaxillary TAVI with a CoreValve prosthesis (Medtronic, Minneapolis, MN). RESULTS:During a follow-up of 535±333 days, 56 patients (28%) reached the primary study end point (all-cause mortality). Independent predictors of long-term mortality were as follows: hemoglobin<12.5 g/dL (hazard risk [HR], 3.62; 95% confidence interval [CI], 2.025-6.468; P<0.001), aortic mean gradient≤41 mm Hg (HR, 2.16; 95% CI, 1.272-3.655; P=0.004), and left atrial diameter>42 mm (HR, 3.09; 95% CI, 1.588-6.019; P=0.001). Our risk-stratification model based on these independent predictors separated patients into 4 groups with high (74%), intermediate (37%), low (18%), and very low (3%) all-cause mortality. CONCLUSIONS:In patients undergoing TAVI, preprocedural assessment of hemoglobin, aortic mean gradient, and left atrial diameter provides independent prognostic information and therefore contributes to improved risk stratification in TAVI.

Recently, moderate and severe postprocedure aortic regurgitations (ARs) have been identified as independent risk factors for short- and midterm mortality after transcatheter aortic valve implantation (TAVI). However, very few data exist on the long-term outcome of postprocedure AR. From 2008 to 2011, 198 consecutive patients with severe aortic stenosis successfully underwent TAVI with the Core Valve prosthesis (Medtronic CV, Minneapolis, Minnesota). After the procedure, patients were subdivided into groups depending on the presence of moderate/severe AR. The primary study end point was death from any cause after TAVI. The secondary end point was defined as cardiovascular death. In study patients (80 +/- 6 years old, logistic European System for Cardiac Operative Risk Evaluation 22 +/- 16%, left ventricular ejection fraction 53 +/- 13%), moderate/severe AR occurred in 28 patients (14%). Despite similar baseline characteristics, patients with moderate/severe AR had higher 30-day and 1-year mortality rates than patients with none/mild AR (21% vs 6%, p = 0.019; 57% vs 16%, p <0.001, respectively). During a mean follow-up of 535 333 days, the primary end point was reached in 54 and the secondary end point in 33 patients. Moderate/severe AR was the strongest independent risk factor of all-cause-mortality (hazard ratio 4.89, 95% confidence interval 2.78 to 8.56, p <0.001) and the strongest independent risk factor of cardiovascular mortality (hazard ratio 7.90, 95% confidence interval 3.95 to 15.81, p <0.001). In conclusion, moderate and severe postprocedure ARs are not uncommon complications after TAVI. Although long-term outcome of patients with none/mild AR is favorable, outcome of patients with moderate/severe AR is dismal. (C) 2012 Elsevier Inc. All rights reserved. (Am J Cardiol 2012;110:1500-1506)

Severe aortic valve stenosis is a common valvular heart disease that is characterized by left ventricular (LV) pressure overload. A lasting effect of pressure overload is LV remodeling, accompanied by concentric hypertrophy and increased myocardial stiffness. Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement for patients with severe symptomatic aortic valve stenosis and high surgical risk. Although TAVI has favorable hemodynamic performance, aortic valve regurgitation (AR) is the most frequent complication because of the specific technique used for implantation of transcatheter valves. During implantation, the calcified native valve is pushed aside, and the prosthesis usually achieves only an incomplete prosthesis apposition. As a consequence, the reported prevalence of moderate and severe AR after TAVI is 6% to 21%, which is considerably higher than that after a surgical valve replacement. Although mild AR probably has minor hemodynamic effects, even moderate AR might result in serious consequences. In moderate and severe AR after TAVI, a normal-sized LV with increased myocardial stiffness has been exposed to volume overload. Because the noncompliant LV is unable to raise end-diastolic volume, the end-diastolic pressure increases, and the forward stroke volume decreases. In recent years, an increasing number of patients have successfully undergone TAVI. Despite encouraging overall results, a substantial number of patients receive neither symptomatic nor prognostic benefits from TAVI. Aortic valve regurgitation has been considered a potential contributor to morbidity and mortality after TAVI. Therefore, various strategies and improvements in valve designs are mandatory to reduce the prevalence of AR after TAVI.

This case illustrates the awareness that must be taken of the high morphological risk due to the calcifications of both, the aortic and mitral annulus in elderly patients when performing transapical aortic valve implantation. In an 86-year-old, multimorbid woman (logistic EuroSCORE = 27%) with symptomatic aortic stenosis (annular diameter = 23.4 mm) and severe mitral annular calcification, the implantation of a 26-mm Edwards SAPIEN (Edwards Lifesciences, Irvine, California, United States) valve in aortic position was primary successful, with no paravalvular leakage, valve instability, or coronary malperfusion. Second, a persisting transmural bleeding led to hypovolemic shock, which could not be stabilized even after going on cardiopulmonary bypass, and the patient died in the operation room. The autopsy showed a subvalvular ventricular rupture due to a transmural perforation of the calcified fibrotic annulus during valvuloplasty.

AimsThis prospective study aimed to evaluate the prognostic impact of left ventricular ejection fraction (LVEF) and aortic mean gradient patterns on outcome after transcatheter aortic valve implantation (TAVI).Methods and resultsFrom 2008 to 2011, 202 consecutive patients with severe symptomatic aortic valve stenosis (aortic valve area <1.0 cm2) were submitted to TAVI. Patients were divided into four groups according to LVEF (>50% vs. ≤50%) and aortic mean pressure gradient (>40 mmHg vs. ≤40 mmHg): group 1, preserved LVEF/high gradient (n = 86); group 2, preserved LVEF/low gradient (n = 27); group 3, reduced LVEF/high gradient (n = 45); and group 4, reduced LVEF/low gradient (n = 44). A CoreValve prosthesis (Medtronic, Minneapolis, MN, USA) was inserted retrogradely. Echocardiography was performed before and 1 year after TAVI. The primary study endpoint (1‐year all‐cause mortality) was reached in 47 patients (23%). All‐cause mortality was lowest in group 1 (14%), intermediate in group 2 (22%) and group 3 (27%), and highest in group 4 (39%) (P = 0.007). In survivors, aortic mean gradient decreased in all patients (baseline 48 ± 13 mmHg vs. 10 ± 4 mmHg at 1 year, P < 0.001). LVEF improved in group 3 and group 4 (baseline 42 ± 8% vs. 51 ± 11% at 1 year, P < 0.001).ConclusionSevere aortic stenosis with low gradient and/or reduced LVEF is associated with worse outcome after TAVI compared with aortic stenosis with preserved LVEF/high gradient. The evaluation of these haemodynamic parameters may help to improve risk stratification in patients undergoing TAVI.

Background Transcatheter aortic valve implantation (TAVI) has emerged as an alternative technique in patients with severe symptomatic aortic valve stenosis. However, a number of patients have no benefit after implantation. This prospective study attempted to identify predictors of poor treatment response.Methods From June 2008 to September 2010, consecutive patients with symptomatic severe aortic valve stenosis and high surgical risk were submitted to TAVI with the CoreValve prosthesis (Medtronic, Minneapolis, MN). The primary end point was all-cause mortality at 6 months. Secondary end point (poor treatment response) was defined as no improvement of symptoms assessed with the New York Heart Association class 6 months after TAVI.Results A total of 145 patients (mean age 79.1 +/- 6.4 years, mean logistic EuroSCORE 21% +/- 16.2%) were included. During the follow-up period, 23 (15.9%) patients died. Independent predictors of all-cause mortality were as follows: aortic mean gradient <= 40 mm Hg (odds ratio [OR] 3.93), moderate and severe tricuspid valve regurgitation (OR 4.50), and moderate and severe postprocedural aortic valve regurgitation (OR 4.26). In 122 surviving patients, 25 patients (20%) showed no improvement in symptoms. Independent predictors of poor treatment response were severe mitral valve regurgitation (OR 7.42) and moderate and severe postprocedural aortic valve regurgitation (OR 10.1).Conclusions Cardiac comorbidities (low-gradient aortic stenosis, tricuspidal valve regurgitation) are associated with all-cause mortality, whereas mitral valve regurgitation is a risk factor for poor treatment response after TAVI. Postprocedural aortic valve regurgitation is a strong predictor of both-mortality and poor treatment response. (Am Heart J 2011;162:238-245.e1.)

Revascularization of coronary artery lesions should be based on objective evidence of ischemia, as recommended by the guidelines of the European Society of Cardiology. However, even in the case of stable coronary artery disease and elective percutaneous coronary intervention (PCI), pre-procedural noninvasive stress test results are available in a minority of patients only. It is common practice for physicians to make decisions on revascularization in the catheterization laboratory after a cursory review of the angiogram, despite the well-recognized inaccuracy of such an approach. Myocardial fractional flow reserve (FFR) measured by a coronary pressure wire is a specific index of the functional significance of a coronary lesion, with superior diagnostic accuracy for the detection of ischemia than any noninvasive stress test. FFR trials on patients with single and multivessel disease, such as the DEFER and FAME studies, have demonstrated that the clinical benefit of PCI with respect to patient outcome is greatest when revascularization is limited to lesions inducing ischemia, whereas lesions not inducing ischemia should be treated medically.

Transcatheter aortic valve implantation (TAVI) is an alternative therapy for symptomatic severe aortic valve stenosis in high-risk patients with several co-morbidities. We evaluated the 1-year effects of TAVI on quality of life, exercise capacity, neurohormonal activation, and myocardial hypertrophy. From June 2008 to October 2009, consecutive patients aged ≥75 years with symptomatic severe aortic valve stenosis (area <1 cm2) and a logistic euroSCORE ≥15% or aged >60 years with additional specified risk factors underwent TAVI. An aortic valve prosthesis (CoreValve) was inserted in a retrograde fashion. Examinations were performed before and 30 days and 1 year after TAVI. An assessment of the quality of life (Minnesota Living with Heart Failure Questionnaire), a 6-minute walking test, measurement of B-type natriuretic peptide, and echocardiography were performed. In 51 patients (mean age 78 ± 6.6 years, mean left ventricular ejection fraction 58.4 ± 12.2%), the follow-up examinations were performed after TAVI. The 1-year follow-up visit after TAVI revealed significantly improved quality of life (baseline Minnesota Living with Heart Failure Questionnaire score 39.6 ± 19 vs 26.1 ± 18, p <0.001) and more distance covered in the 6-minute walking test (baseline 185 ± 106 vs 266 ± 118 m, p <0.001). The B-type natriuretic peptide level had decreased (baseline 642 ± 634 vs 323 ± 266 pg/ml, p <0.001), and the left ventricular mass index had decreased (156 ± 45 vs 130 ± 42 g/m2, p <0.001). The left ventricular diameter and ejection fraction remained unchanged. In conclusion, TAVI leads to significantly reduced neurohormonal activation, regression of myocardial hypertrophy, and lasting enhancement of quality of life and exercise capacity in patients with symptomatic and severe aortic stenosis 1 year after intervention.

BACKGROUND:Low-flow, low-gradient aortic stenosis is associated with relevant postoperative mortality whereas conservative management results in dismal prognosis. We present the initial experience of low-flow, low-gradient aortic stenosis treated with transcatheter aortic valve implantation (TAVI). METHODS:From June 2008 to December 2010 167 consecutive patients with native severe aortic stenosis and an excessive operative risk underwent TAVI. Of these, 15 patients presented with low-flow, low-gradient aortic stenosis (aortic valve area < 1 cm(2) , left ventricular (LV) ejection fraction < 40%, aortic mean gradient < 40 mm Hg). The CoreValve prosthesis 18-F-generation (Medtronic, Minneapolis, Minnesota) was inserted retrograde. Clinical follow-up and echocardiography were performed 6 months after procedure. RESULTS:Patients with low-flow, low-gradient aortic stenosis (mean LV ejection fraction 32 ± 6%, mean aortic gradient 27 ± 7 mm Hg) had higher all-cause mortality 6 months after TAVI compared to patients without low-flow, low-gradient aortic stenosis (33% vs. 13%, P = 0.037). In the surviving 10 patients with low-flow, low-gradient aortic stenosis, LV ejection fraction increased (34 ± 6% before vs. 46 ± 11% 6 months after TAVI, p = 0.005) and more distance covered in the 6-minute walk test (218 ± 102 meters before vs. 288 ± 129 meters 6 months after TAVI, p = 0.038). CONCLUSION:Our study suggests that TAVI is feasible in patients with severe co-morbidities and low-flow, low-gradient aortic stenosis. Within the first 6 months after treatment all-cause mortality was considerable high, but the surviving patients showed symptomatic benefit and significant improvement of myocardial function and exercise capacity.

Purpose. To evaluate the usefulness of serial compression B-scan and Doppler sonography (US) in screening for deep venous thrombosis (DVT) of the lower extremities in patients with spinal cord injuries.Method. Patients with paraplegia and tetraplegia due to spinal cord injuries were screened by a serial compression B-scan and Doppler US protocol for DVT of the bilateral lower extremities within the first 36 hours after admission, at day 7 and at day 21. In patients with DVT, a follow-up US examination was performed 3 weeks after diagnosis to assess thrombi distribution.Results. Between January 2007 and March 2008, a total of 115 patients (75 males, 40 females), aged 19 to 85 years, were included. The first US examination documented a DVT in 44 cases (38.3%). After an initial negative scan, sonography after 7 days and 21 days showed DVT in 6 patients and 2 patients, respectively. Cumulative rate of DVT after the first 3 weeks was 45.2% (n=52). Follow-up US after 3 weeks in patients with DVT documented a complete recanalization in 19 patients (36.5%), no change in 12 patients (23.1%), and residual thrombi with partial recanalization in 21 patients (40.4%).Conclusion. Our study supports the use of serial compression B-scan and Doppler US as a screening tool for DVT of the lower extremities in patients with spinal cord injuries early after injury. (C) 2009 Wiley Periodicals, Inc. J Clin Ultrasound 38:17-20, 2010; Published online in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/jcu.20634

In this prospective study, we aimed to document the rate and localization of deep venous thromboses in patients with spinal cord injuries. Patients with paraplegia or tetraplegia were screened by a serial color duplex sonography protocol for deep venous thrombosis within the first 36 hours after admission, at day 7, and at day 21. Sonography was performed by a complete scan including the veins below the knee. A total of 139 patients were included (19-90 years, 63.5% male). Cumulative rate of deep venous thrombosis after 3 duplex scans was 45.3% (n = 63). In 71.4% (n = 45), thromboses were localized below the knee. Because of the relevant number of distal vein thromboses, inclusion of the calf veins during screening scans is suggested. Further studies are needed to analyze the clinical benefit of diagnosing and treating distal vein thromboses.

Pregabalin (PGB) is an antiepileptic drug that is also approved for neuropathic pain and for the treatment of generalized anxiety disorder (GAD) [1] [3] [8] [9]. PGB is a GABA analogue that is reported to have mild side effects including transient dizziness, somnolence, dry mouth and ataxia [14]. Edemas are reported to occur in up to 8% of the treated patients but only in higher doses [7]. In the literature to date, there are only two reports on PGB-related edema [12] [15], one of them caused by withdrawal of the drug [12] and one observed with medium dosages of PGB [15]. The authors of the latter case report conclude, however, that edema with PGB treatment may be self-limited, transient and therefore not frequently found. We report here on three cases of severe and persistent edema in young females with GAD and a history of premenstrually-related cyclic edema, one of which was succesfully treated with a new oral contraceptive regimen.

BACKGROUND:Fractional flow reserve (FFR) measurements in the so-called gray-zone range of > or = 0.75 and < or =0.80 are associated with uncertainty concerning the guidance of patient therapy. It is unclear whether any difference in clinical outcome exists when revascularization treatment of FFR-evaluated lesions in this borderline range is deferred or performed. The objective of this study is to compare the clinical outcome of these patients with respect to their recommended treatment strategy. METHODS:Out of a single center database of 900 consecutive patients with stable coronary artery disease, 97 patients with borderline FFR measurements were identified and included in the study. The rate of major adverse cardiac events (MACE; cardiac death, myocardial infarction (MI), coronary revascularization) and the presence of angina were evaluated at follow-up. RESULTS:A total of 48 patients were deferred from revascularization and 49 patients underwent revascularization. There was no difference in risk profile between these groups. At a mean follow-up of 24+/-16 months, event-free survival in the deferred group was significantly better regarding overall MACE, combined rate of cardiac death, and MI, as well as MACE related to the FFR-evaluated vessel. No difference with regard to the presence of angina was observed. CONCLUSIONS:Patients with coronary lesions in the borderline FFR range can be deferred from revascularization without putting them at increased risk for major adverse events. Revascularization may be considered in the course of therapy on an individual basis if typical angina persists or worsens despite maximal medical treatment.

BACKGROUND:Treatment of symptomatic coronary artery disease with percutaneous intervention requires antithrombotic therapy. Patients with elevated thromboembolic risk benefit from therapy with glycoprotein IIb/IIIa inhibitors. The safety and effectiveness of glycoprotein IIb/IIIa inhibition have been well documented in clinical trials. Drug-induced bleeding complications in elderly patients have not been specifically addressed.METHODS:Between 2006 and 2009, a total of 439 unselected patients 80 years of age and older undergoing percutaneous intervention for symptomatic coronary artery disease were included in the present nonrandomized retrospective study. In one-half of the patients, glycoprotein IIb/IIIa inhibitors were administered peri-interventionally. The in-hospital occurrence of bleeding complications (access site, gastrointestinal and cerebral) were analyzed in the groups with and without glycoprotein IIb/IIIa inhibitors.RESULTS:The mean age of the patients was 84 years. Nearly all patients (95%) received dual antiplatelet therapy. Patients treated with glycoprotein IIb/IIIa inhibitors had more complex coronary lesions and bypass graft interventions, and a tendency toward more access site bleeding complications than patients without inhibitors, which included femoral hematomas (4.6% versus 2.3%, respectively; P not significant) and femoral pseudoaneurysms (6% versus 3.2%, respectively; P not significant). The rate of blood transfusion was equal in both groups (0.9%). Major hemorrhagic events did not occur. Vessel closure devices were used more often in patients without glycoprotein inhibition.CONCLUSIONS:An increase in minor bleedings must be expected when using glycoprotein IIb/IIIa inhibitors in patients 80 years of age and older. However, this issue must not prevent this treatment option from being offered to elderly patients. There appears to be no elevated risk for major bleeding complications. Broadened use of vascular closure devices in this specific patient population may lower the rate of access site complications.

The technique of miniaturized cardiopulmonary bypass (M-CPB) for beating-heart coronary artery bypass grafting (CABG) is relatively new and has potential advantages when compared to conventional cardiopulmonary bypass (CPB). M-CPB consists of less tubing length and requires less priming volume. The system is phosphorylcholine coated and results in minimal pump-related inflammatory response and organ injury. Finally, this technique combines the advantages of the off-pump CABG (OPCAB) with the better exposure provided by CPB to facilitate complete revascularization. The hypothesis is that CABG with M-CPB has a better outcome in terms of complete coronary revascularization and perioperative results as that compared to off-pump CABG (OPCAB). In a retrospective study, 302 patients underwent beating-heart CABG, 117 (39%) of them with the use of M-CPB and 185 (61%) with OPCAB. After propensity score matching 62 patients in both groups were demographically similar. The most important intra- and early-postoperative parameters were analyzed. Endpoints were hospital mortality and complete revascularization. Hospital mortality was comparable between the groups. The revascularization was significantly more complete in M-CPB patients than in patients in the OPCAB group. Beating-heart CABG with M-CPB is a safe procedure and it provides an optimal operative exposure with significantly more complete coronary revascularization when compared to OPCAB. Beating-heart CABG with the support of a M-CPB is the operation of choice when total coronary revascularization is needed.

The application of tricuspid annular plane systolic excursion (TAPSE) as an additional echocardiographic tool to analyse right ventricular (RV) systolic function has been recently established and two-dimensional-guided M-mode measurements of systolic long axis function of the RV are simple, repeatable, and highly reproducible. However, rare data are available on normal values. We aimed to analyse normal values in healthy women > 70 years of age.In a cross-sectional survey, we investigated a cohort of randomly selected, non-hospitalized women > 70 years of age. History of myocardial infarction, valvular heart disease, and diastolic dysfunction were exclusion criteria. In order to rule out left ventricular or RV dysfunction, a normal left ventricular ejection fraction and normal values of B-type natriuretic peptide (BNP) were necessary prior to study inclusion. A detailed echocardiographic examination was performed. A total of 80 participants were included (mean age 75 +/- 2.6 years). Mean left ventricular ejection fraction was 63.8 +/- 5.7%. Tissue Doppler derived mean E/E' ratio was 10 +/- 2.3. Mean right atrial diameter was 31.3 +/- 4.7 mm. Mean values for RV outflow tract and RV dimension were 27.3 +/- 3.6 and 28.8 +/- 3.7 mm, respectively. Mean TAPSE was 23.7 +/- 3.5 mm. Mean value of BNP was normal (42.5 +/- 35.7 pg/mL).In women > 70 years of age without heart failure, structural heart disease, and neurohormonal activation, normal TAPSE values are similar to 24 mm.

Background This prospective study was designed to evaluate the hemodynamic results of transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis (Medtronic, Minneapolis, Minnesota) and the effects on left ventricular function.Methods From June 2008 to June 2009, consecutive patients with severe symptomatic aortic valve stenosis (aortic valve area <1 cm(2)) and the indication for TAVI were included. Aortic valve prosthesis was inserted retrograde. Examinations of study patients were performed before, 30 days, and 6 months after TAVI and comprised measurement of B-type natriuretic peptide and echocardiography. Severe prosthesis-patient mismatch was defined as an indexed effective aortic valve area <= 0.65 cm(2)/m(2).Results In 39 patients, follow-up examinations were performed after TAVI. Severe prosthesis-patient mismatch seldom occurred (n = 1), but mild to moderate aortic valve regurgitation due to paravalvular leaks was common (n = 24, 62%). After 6 months, left ventricular mass index declined (158 +/- 46 vs 138 +/- 45 g/m(2), P = .001), and peak early diastolic mitral annular velocity (E') and peak systolic mitral annular velocity (S') increased (P = .004 and P < .001, respectively). B-type natriuretic peptide levels decreased (744 +/- 708 at baseline vs 367 +/- 273 at 30 days, P = .003, 279 -/+ 186 pg/mL at 6 months, P = .001). Left ventricular diameters and ejection fraction remained unchanged.Conclusion Despite the high incidence of paravalvular regurgitation after TAVI, hemodynamic results were favorable. Furthermore, TAVI had positive effects on left ventricular remodeling and improved neurohormonal activity, myocardial hypertrophy, and diastolic function. (Am Heart J 2010;159:926-32.)