Elimination of Benign Ventricular Premature Beats or Ventricular Tachycardia with Catheter Ablation versus Two Different Optimal Antiarrhythmic Drug Treatment Regimens (Sotalol or Verapamil/Flecainide).

BACKGROUND: Symptomatic idiopathic ventricular arrhythmias (VA), including premature beats (VPB) and nonsustained ventricular tachycardia (VT) are commonly encountered arrhythmias. Although these VA are usually benign, their treatment can be a challenge to primary and secondary health care providers. Mainstay treatment is comprised of antiarrhythmic drugs (AAD) and, in case of drug intolerance or failure, patients are referred for catheter ablation to tertiary health care centers. These patients require extensive medical attention and drug regimens usually have disappointing results. A direct comparison between the efficacy of the most potent AAD and primary catheter ablation in these patients is lacking. The ECTOPIA trial will evaluate the efficacy of 2 pharmacological strategies and 1 interventional approach to: suppress the VA burden, improve the quality of life (QoL), and safety. HYPOTHESIS: We hypothesize that flecainide/verapamil combination and catheter ablation are both superior to sotalol in suppressing VA in patients with symptomatic idiopathic VA. STUDY DESIGN: The Elimination of Ventricular Premature Beats with Catheter Ablation versus Optimal Antiarrhythmic Drug Treatment (ECTOPIA) trial is a randomized, multicenter, prospective clinical trial to compare the efficacy of catheter ablation versus optimal AAD treatment with sotalol or flecainide/verapamil. One hundred eighty patients with frequent symptomatic VA in the absence of structural heart disease or underlying cardiac ischemia who are eligible for catheter ablation with an identifiable monomorphic VA origin with a burden ≥5% on 24-h ambulatory rhythm monitoring will be included. Patients will be randomized in a 1:1:1 fashion. The primary endpoint is defined as >80% reduction of the VA burden on 24-h ambulatory Holter monitoring. After reaching the primary endpoint, patients randomized to one of the 2 AAD arms will undergo a cross-over to the other AAD treatment arm to explore differences in drug efficacy and QoL in individual patients. Due to the use of different AAD (with and without ß-blocking characteristics) we will be able to explore the influence of alterations in sympathetic tone on VA burden reduction in different subgroups. Finally, this study will assess the safety of treatment with 2 different AAD and ablation of VA.

Is the difference in outcome between men and women treated by primary percutaneous coronary intervention age dependent? Gender difference in STEMI stratified on age.

AIM: Poorer outcomes in women with ST-elevation myocardial infarction (STEMI) are often attributed to gender differences in baseline characteristics. However, these may be age dependent. We examined the importance of gender in separate age groups of patients with STEMI undergoing primary percutaneous coronary intervention (PPCI). METHODS AND RESULTS: Data of 6746 consecutive patients with STEMI admitted for PPCI between 1998 and 2008 in our hospital were evaluated. Age was stratified into two groups, <65 years (young group) and ≥65 years (elderly). Endpoints were enzymic infarct size as well as 30-day and 1 year mortality. We studied a total of 4991 (74.0%) men and 1755 (26.0%) women; 40% of women were <65 years and 60% of men were <65 years of age. In the elderly group (≥65 years), women had more frequently diabetes and hypertension while they smoked less frequently than men. Younger women smoked more often than similarly aged men and had more hypertension. At angiography, single-vessel disease and TIMI 3 flow before PPCI was more present in younger women than men, whereas these differences were not found in the older age group. Patient delay before admission was shorter in men at all ages, while women had lower creatine kinase levels. Younger women had a higher mortality after 30 days (HR 2.1, 95% CI 1.3-3.4) and at 1 year (HR 1.7, 95% CI 1.2-2.6), whereas in the older age group women mortality rates were higher at 30 days (HR 1.5, 95% CI 1.1-2.0) but not at 1 year (HR 1.2, 95% CI 0.9-1.5). After multivariate analysis, 1-year mortality remained significantly higher in women at younger age (HR 1.7, 95% CI 1.1-2.5). Patient delay before admission was shorter in men in both age groups. Creatine kinase levels were in both age groups higher in men. CONCLUSIONS: Differences in mortality between men and women with STEMI treated with PPCI are age dependent. Although young women have less obstructive coronary artery disease and more often TIMI 3 flow before PCI (suggesting a lower risk), survival was worse compared to similarly aged men. Women had a longer patient delay compared to men, but this was not related to gender-specific mortality.

Age-dependent differences in diabetes and acute hyperglycemia between men and women with ST-elevation myocardial infarction: a cohort study.

BACKGROUND: Both acute hyperglycemia as diabetes results in an impaired prognosis in ST-elevation myocardial infarction (STEMI) patients. It is unknown whether there is a different prevalence of diabetes and acute hyperglycemia in men and women within age-groups. METHODS: Between 2004 and 2010, 4640 consecutive patients (28% women) with STEMI, were referred for primary PCI. Patients were stratified into two age groups, < 65 years (2447 patients) and ≥65 years (2193 patients). Separate analyses were performed in 3901 patients without diabetes. Diabetes was defined as known diabetes or HbA1c ≥6.5 mmol/l at admission. RESULTS: The prevalence of diabetes was comparable between women and men in the younger age group (14% vs 12%, p = 0.52), whereas in the older age group diabetes was more prevalent in women (25% vs 17% p < 0.001). In patients without diabetes, admission glucose was comparable between both genders in younger patients (8.1 ± 2.0 mmol/l vs 8.0 ± 2.2 mmol/l p = 0.36), but in older patients admission glucose was higher in women than in men (8.7 ± 2.1 mmol/l vs 8.4 ± 2.1 mmol/l p = 0.028). After multivariable analyses, the occurrence of increased admission glucose was comparable between men and women in the younger age group (OR 1.1, 95%CI 0.9-1.5), but increased in women in the older age group (OR 1.3, 95% CI 1.1-1.7). Both diabetes and hyperglycemia were associated with a higher one-year mortality in both men and women. CONCLUSIONS: The differences between men and women in hyperglycemia and diabetes in patients with STEMI are age dependent and can only be observed in older patients. This may have implications for medical treatment and should be investigated further.

How should I treat acute valve regurgitation?

BACKGROUND: An 81-year-old male with symptoms of angina and dyspnoea (NYHA 3), a history of coronary bypass surgery, a transaortic peak gradient of 109 mmHg on transthoracic echocardiography and a logistic Euro-SCORE of 21.6 was deemed suboptimal for surgery by a multidisciplinary team and was accepted for TAVI. INVESTIGATION: Preprocedural diameter of the native aortic root was 24.4 mm on transthoracic echocardiography (TTE), 26.9 mm on contrast angiography and 26.8 mm by 30.2 mm on multislice computed tomography (MSCT). DIAGNOSIS: heavy calcification of the aortic root and coronary arteries by MSCT. TREATMENT: Transcatheter aortic calve replacement with an 29 mm CoreValve prosthesis.

In-hospital complications after transcatheter aortic valve implantation revisited according to the Valve Academic Research Consortium definitions.

OBJECTIVES: To determine the occurrence of in-hospital complications after transcatheter aortic valve implantation (TAVI) according to the Valve Academic Research Consortium (VARC) criteria in addition to the length of stay (LOS). BACKGROUND: The absence of uniformity in endpoint definitions challenges the comparison between previously reported major adverse cerebro- and cardiovascular event rates after TAVI. To address this, in 2009, the VARC was established aiming to provide standardized endpoint definitions for TAVI clinical trials. METHODS: Between November 2005 and September 2010, we prospectively enrolled 150 consecutive patients who underwent TAVI with the Medtronic CoreValve System in our institution. Complications, prosthetic valve associated endpoints, and therapy-specific endpoints were defined according to the definitions provided by the VARC. RESULTS: The mean age (±SD) was 81 (±7) years and 55% were female. Thirty-day or in-hospital mortality was 11%, and the 30-day combined safety endpoint was 22%. Seventy-six patients (51%) had ≥1 cardiovascular and/or noncardiovascular complication of whom 16 also underwent a new permanent pacemaker implantation (PPI). In the 74 patients with uneventful TAVI, 12 patients (8%) underwent PPI. TAVI was truly uneventful in 62 patients (41%). Bleeding complications were observed most frequently (31%), followed by acute kidney injury (18%), vascular complications (16%), and stroke/TIA (11%). The median LOS in patients with a complicated and a truly uncomplicated TAVI was 14.0 (8.0-20.5) and 8.0 (7.0-10.8) days, respectively (P < 0.001). CONCLUSION: TAVI was associated with ≥1 cardiovascular and/or noncardiovascular event in 51% of the patients; new PPI was needed in another 8%, and TAVI was truly uncomplicated in 41%. Complications and need for new PPI significantly prolonged LOS.

Frequency, determinants, and prognostic effects of acute kidney injury and red blood cell transfusion in patients undergoing transcatheter aortic valve implantation.

OBJECTIVES: To determine the frequency and independent predictors of acute kidney injury (AKI) in addition to the prognostic implications of both AKI and periprocedural red blood cell (RBC) transfusions on 30 day and cumulative late mortality in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: RBC transfusions have been reported to predict AKI following TAVI. Data on the prognostic implications of both factors, however, are lacking. METHODS: 126 consecutive patients underwent TAVI with the Medtronic CoreValve Revalving System. AKI was defined according to the valve academic research consortium definitions as an absolute increase in serum creatinine ≥0.3 mg dL⁻¹ (≥26.4 µmol L⁻¹) or a percentage increase ≥ 50% within 72 hr following TAVI. RESULTS: Five patients on chronic haemodialysis and three intraprocedural deaths were excluded, leading to a final study population of 118 patients. AKI occurred in 19% of the patients necessitating temporary haemodialysis in 2%. Independent predictors of AKI included: previous myocardial infarction (OR: 5.72; 95% CI: 1.64-19.94), periprocedural (<24 hr) RBC transfusions (OR: 1.29; 95% CI: 1.01-1.70), postprocedural (<72 hr) leucocyte count (OR: 1.18; 95% CI: 1.02-1.37), and logistic EuroSCORE (OR: 1.08; 95% CI: 1.01-1.14). In patients with AKI, 30-day mortality was 23% and cumulative late mortality (median: 13 months) was 55%. AKI (OR: 5.47; 95% CI: 1.23-24.21) and postprocedural leucocyte count (OR: 1.20; 95% CI: 1.03-1.38) were independent predictors of 30-day mortality while AKI (HR: 2.79; 95% CI: 1.36-5.71) was the only independent predictor of late mortality. CONCLUSIONS: AKI following TAVI occurred in 19% of the patients. RBC transfusion was found to be an independent predictor of AKI, which in turn predicted both 30-day and cumulative late mortality.

[Survival and disorders after percutaneous aortic valve replacement]. / Overleving en klachten na percutane aortaklepvervanging.

OBJECTIVE: Description of the characteristics of patients with aortic valve stenosis and high surgical risk considered suitable for percutaneous aortic valve replacement (PAVR) and investigation of the effect of this treatment on survival and the occurrence of complications. DESIGN: Prospective observational single center cohort study. METHOD: Patients with aortic valve stenosis and high surgical risk received a special consultation, after which the heart team decided whether they were considered suitable for PAVR or for surgical valve replacement (AVR). Deaths and complications in the 30 day period after PAVR were registered. The study period was September 2005-January 2009. The EuroSCORE system was used to summarise the patient characteristics, survival was determined by using the Kaplan Meier method, and the subjective health status defined following the New York Heart Association (NYHA) classification. RESULTS: In the study period 166 patients were referred for PAVR of whom 91 (55%) actually underwent PAVR, 16 (10%) underwent surgical valve replacement (AVR), 39 (23%) were rejected for AVR/PAVR and 20 patients (12%) declined surgical treatment. The mean EuroSCORE (SD) for PAVR was 17% (8), for AVR 12% (7) , for patients unsuitable for surgery 19% (12) and for those declining surgery 25% (14). The mortality and risk of stroke 30 days after PAVR were respectively 12 and 13%. Survival at 1 year after PAVR was 73%. This was associated with a significant improvement of the functional class: before PAVR 15% of patients had NYHA class ≤ 2, and afterwards 72%. CONCLUSION: PAVR was associated with a substantial risk of mortality and stroke. The subjective health status of patients did improve substantially after PAVR. In the absence of randomised studies, the authors are of the opinion that PAVR should be restricted to patients who are not considered suitable for surgical valve replacement.

Persistent conduction abnormalities and requirements for pacemaking six months after transcatheter aortic valve implantation.

AIMS: Early conduction abnormalities and need for pacemaking after transcatheter aortic valve implantation (TAVI) is well recognised. It is still unknown, however, if these conduction abnormalities are persistent, and what is the need for permanent pacemaking after 1-month follow-up. In this prospective study, we examined the incidence of post-procedural and 6-month conduction abnormalities and need for permanent pacemaking after TAVI. METHODS AND RESULTS: We examined the 12-lead electrocardiogram (ECG) of 91 consecutive patients in whom a Medtronic CoreValve ReValving System was implanted between November 2005 and April 2009. We evaluated the ECGs before treatment, after treatment, at 1-month and 6-month follow-up. The requirement and timing of permanent pacemaking was documented. The mean age of patients was 81±7 years and the mean logistic EuroSCORE was 16±9%. Median duration of follow-up was 213 days (IQR 64, 519). There was a 39% increase in the frequency of LBBB after TAVI (15% before treatment vs. 54% after treatment, p<0.001). Importantly, there was no significant change in the frequency of LBBB from after treatment to 1- or 6-month follow-up (54% after treatment vs. 42% at 1-month follow-up, p=0.45, and 54% after treatment vs. 45% at 6-month follow-up, p=0.39). Permanent pacemaking was required in 17/91 (19%) of patients. A permanent pacemaker was implanted in 8/17 patients (47%) within seven days of TAVI, in 6/17 (35%) at 7-30 days, and in 3/17 (18%) after 30 days. Male gender, previous myocardial infarction, pre-existing right bundle branch block, actual diameter (mm) of the inflow portion of the CoreValve frame post-implantation and depth of implantation were predictors for new LBBB; pre-treatment QRS duration (msec) and septal wall thickness were predictors for permanent pacemaking. CONCLUSIONS: These results suggest that early conduction abnormalities occurring after TAVI persist at 6-months follow-up. Patient-related, anatomical-related, and procedure-related factors need to be considered in the pathogenesis of conduction abnormalities after TAVI.

Relationship between the logistic EuroSCORE and the Society of Thoracic Surgeons Predicted Risk of Mortality score in patients implanted with the CoreValve ReValving system--a Bern-Rotterdam Study.

BACKGROUND: Surgical risk scores, such as the logistic EuroSCORE (LES) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score, are commonly used to identify high-risk or "inoperable" patients for transcatheter aortic valve implantation (TAVI). In Europe, the LES plays an important role in selecting patients for implantation with the Medtronic CoreValve System. What is less clear, however, is the role of the STS score of these patients and the relationship between the LES and STS. OBJECTIVE: The purpose of this study is to examine the correlation between LES and STS scores and their performance characteristics in high-risk surgical patients implanted with the Medtronic CoreValve System. METHODS: All consecutive patients (n = 168) in whom a CoreValve bioprosthesis was implanted between November 2005 and June 2009 at 2 centers (Bern University Hospital, Bern, Switzerland, and Erasmus Medical Center, Rotterdam, The Netherlands) were included for analysis. Patient demographics were recorded in a prospective database. Logistic EuroSCORE and STS scores were calculated on a prospective and retrospective basis, respectively. RESULTS: Observed mortality was 11.1%. The mean LES was 3 times higher than the mean STS score (LES 20.2% +/- 13.9% vs STS 6.7% +/- 5.8%). Based on the various LES and STS cutoff values used in previous and ongoing TAVI trials, 53% of patients had an LES > or =15%, 16% had an STS > or =10%, and 40% had an LES > or =20% or STS > or =10%. Pearson correlation coefficient revealed a reasonable (moderate) linear relationship between the LES and STS scores, r = 0.58, P < .001. Although the STS score outperformed the LES, both models had suboptimal discriminatory power (c-statistic, 0.49 for LES and 0.69 for STS) and calibration. CONCLUSIONS: Clinical judgment and the Heart Team concept should play a key role in selecting patients for TAVI, whereas currently available surgical risk score algorithms should be used to guide clinical decision making.

Changes in mitral regurgitation after transcatheter aortic valve implantation.

OBJECTIVES: To assess the acute and intermediate changes in mitral regurgitation (MR) severity after transcatheter aortic valve implantation (TAVI) with the CoreValve Revalving SystemTM (CRS). BACKGROUND: Following surgical aortic valve replacement, improvement in MR is reported in 27-82% of the patients. The changes in MR severity following CRS implantation are unknown. METHODS: Transthoracic echocardiography was performed in 79 consecutive patients before and after treatment, and at the first outpatient visit. Left ventricular dimensions and ejection fraction (LVEF), left atrial (LA) size, and aortic gradient were measured. MR was assessed by color flow mapping and was graded as none, mild, moderate, or severe. It was defined as organic or functional. The depth of CRS implantation was measured by angiography. RESULTS: Post-treatment, the mean gradient decreased from 48 +/- 16 mm Hg to 9 +/- 5 mm Hg (P < 0.0001). There was no significant change in the left ventricular dimensions, LA size, and LVEF. MR pretreatment was mild, moderate, or severe in 57%, 18%, and 1% of the patients, respectively. It was defined as organic in 27 patients (36%) and functional in 27 patients (36%). The degree of MR remained unchanged in 61% of the patients, improved in 17%, and worsened in 22%. MR improvement was associated with a lower baseline LVEF (P = 0.02). There was no association between the changes in MR severity and the depth of CRS implantation. CONCLUSIONS: Most patients who underwent TAVI had some degree of MR. Overall there was no change in the degree of MR post-treatment. Patients in whom MR improved had a lower LVEF at baseline.

Three dimensional evaluation of the aortic annulus using multislice computer tomography: are manufacturer's guidelines for sizing for percutaneous aortic valve replacement helpful?

AIMS: To evaluate the effects of applying current sizing guidelines to different multislice computer tomography (MSCT) aortic annulus measurements on Corevalve (CRS) size selection. METHODS AND RESULTS: Multislice computer tomography annulus diameters [minimum: D(min); maximum: D(max); mean: D(mean) = (D(min) + D(max))/2; mean from circumference: D(circ); mean from surface area: D(CSA)] were measured in 75 patients referred for percutaneous valve replacement. Fifty patients subsequently received a CRS (26 mm: n = 22; 29 mm: n = 28). D(min) and D(max) differed substantially [mean difference (95% CI) = 6.5 mm (5.7-7.2), P < 0.001]. If D(min) were used for sizing 26% of 75 patients would be ineligible (annulus too small in 23%, too large in 3%), 48% would receive a 26 mm and 12% a 29 mm CRS. If D(max) were used, 39% would be ineligible (all annuli too large), 4% would receive a 26 mm, and 52% a 29 mm CRS. Using D(mean), D(circ), or D(CSA) most patients would receive a 29 mm CRS and 11, 16, and 9% would be ineligible. In 50 patients who received a CRS operator choice corresponded best with sizing based on D(CSA) and D(mean) (76%, 74%), but undersizing occurred in 20 and 22% of which half were ineligible (annulus too large). CONCLUSION: Eligibility varied substantially depending on the sizing criterion. In clinical practice both under- and oversizing were common. Industry guidelines should recognize the oval shape of the aortic annulus.

Assisted circulation using the Tandemhear , percutaneous transseptal left ventricular assist device, during percutaneous aortic valve implantation: the Rotterdam experience.

AIMS: The morbidity and mortality of surgical aortic valve replacement are increased in elderly patients with multiple high risk comorbid conditions. Percutaneous prosthetic aortic valve replacement (PAVR) via the femoral arterial approach is feasible in selected patients, who are poor operative candidates, with satisfactory short term outcomes. It is conceivable that patients with poor LV function may benefit from periprocedural cardio-circulatory support. We evaluated the short-term safety and efficacy of using the TandemHeart PTVA System (p-LVAD) to deliver extracorporeal circulatory support in patients undergoing PAVR. METHODS AND RESULTS: Between April 2006 and May 2007 the TandemHeart was used in 10 patients (age: range 64-85, median 80) undergoing elective PAVR using the CoreValve Revalving System. The median (range) time for implementation of circulatory support was 32 (22-40) minutes. A pump flow up to 4.6 L/min was achieved. Systemic haemodynamics were maintained in all but one patient. The median (range) systemic arterial pressure (MBP) was 77 (67-89) mmHg at baseline and 76 (61-91) mmHg after pump functioning. A major systolic blood pressure drop (systolic blood pressure < 70 mmHg, pulse pressure < 10 mmHg, occurred in one patient due to PAVR related pericardial tamponade. Median (range) duration of support was 64 (60-93) minutes. Successful weaning was achieved in all patients. There was one in hospital death. Survival at 12 months was 90%, at 15 months 70%. Vascular access site complications were seen in two patients. One patient suffered a mild to moderate access site bleeding, one a local wound infection. There was no technical device failure. CONCLUSIONS: The TandemHeart-PTVA may provide a valuable safeguard during high risk PAVR procedures and enables precise delivery of the CoreValve prosthesis. The rate of device related cardiac and vascular complications was acceptable.

Geometry and degree of apposition of the CoreValve ReValving system with multislice computed tomography after implantation in patients with aortic stenosis.

OBJECTIVES: Using multislice computed tomography (MSCT), we sought to evaluate the geometry and apposition of the CoreValve ReValving System (CRS, Medtronic, Luxembourgh, Luxembourgh) in patients with aortic stenosis. BACKGROUND: There are no data on the durability of percutaneous aortic valve replacement. Geometric factors may affect durability. METHODS: Thirty patients had MSCT at a median 1.5 months (interquartile range [IQR] 0 to 7 months) after percutaneous aortic valve replacement. Axial dimensions and apposition of the CRS were evaluated at 4 levels: 1) the ventricular end; 2) the nadir; 3) central coaptation of the CRS leaflets; and 4) commissures. Orthogonal smallest and largest diameters and cross-sectional surface area were measured at each level. RESULTS: The CRS (26-mm: n = 14, 29-mm: n = 16) was implanted at 8.5 mm (IQR 5.2 to 11.0 mm) below the noncoronary sinus. None of the CRS frames reached nominal dimensions. The difference between measured and nominal cross-sectional surface area at the ventricular end was 1.6 cm(2) (IQR 0.9 to 2.6 cm(2)) and 0.5 cm(2) (IQR 0.2 to 0.7 cm(2)) at central coaptation. At the level of central coaptation the CRS was undersized relative to the native annulus by 24% (IQR 15% to 29%). The difference between the orthogonal smallest and largest diameters (degree of deformation) at the ventricular end was 4.4 mm (IQR 3.3 to 6.4 mm) and it decreased progressively toward the outflow. Incomplete apposition of the CRS frame was present in 62% of patients at the ventricular end and was ubiquitous at the central coaptation and higher. CONCLUSIONS: Dual-source MSCT demonstrated incomplete and nonuniform expansion of the CRS frame, but the functionally important mid-segment was well expanded and almost symmetrical. Undersizing and incomplete apposition were seen in the majority of patients.

A comparison of patient characteristics and 30-day mortality outcomes after transcatheter aortic valve implantation and surgical aortic valve replacement for the treatment of aortic stenosis: a two-centre study.

AIMS: It is unclear whether transcatheter aortic valve implantation (TAVI) addresses an unmet clinical need for those currently rejected for surgical aortic valve replacement (SAVR) and whether there is a subgroup of high-risk patients benefiting more from TAVI compared to SAVR. In this two-centre, prospective cohort study, we compared baseline characteristics and 30-day mortality between TAVI and SAVR in consecutive patients undergoing invasive treatment for aortic stenosis. METHODS AND RESULTS: We pre-specified different adjustment methods to examine the effect of TAVI as compared with SAVR on overall 30-day mortality: crude univariable logistic regression analysis, multivariable analysis adjusted for baseline characteristics, analysis adjusted for propensity scores, propensity score matched analysis, and weighted analysis using the inverse probability of treatment (IPT) as weights. A total of 1,122 patients were included in the study: 114 undergoing TAVI and 1,008 patients undergoing SAVR. The crude mortality rate was greater in the TAVI group (9.6% vs. 2.3%) yielding an odds ratio [OR] of 4.57 (95%-CI 2.17-9.65). Compared to patients undergoing SAVR, patients with TAVI were older, more likely to be in NYHA class III and IV, and had a considerably higher logistic EuroSCORE and more comorbid conditions. Adjusted OR depended on the method used to control for confounding and ranged from 0.60 (0.11-3.36) to 7.57 (0.91-63.0). We examined the distribution of propensity scores and found scores to overlap sufficiently only in a narrow range. In patients with sufficient overlap of propensity scores, adjusted OR ranged from 0.35 (0.04-2.72) to 3.17 (0.31 to 31.9). In patients with insufficient overlap, we consistently found increased odds of death associated with TAVI compared with SAVR irrespective of the method used to control confounding, with adjusted OR ranging from 5.88 (0.67-51.8) to 25.7 (0.88-750). Approximately one third of patients undergoing TAVI were found to be potentially eligible for a randomised comparison of TAVI versus SAVR. CONCLUSIONS: Both measured and unmeasured confounding limit the conclusions that can be drawn from observational comparisons of TAVI versus SAVR. Our study indicates that TAVI could be associated with either substantial benefits or harms. Randomised comparisons of TAVI versus SAVR are warranted.

Population characteristics, treatment assignment and survival of patients with aortic stenosis referred for percutaneous valve replacement.

AIMS: An increasing number of patients are referred for percutaneous aortic valve replacement (PAVR). Although case studies are available on outcome of selected patients, little is known about the demographics, treatment assignment and survival of the total referred population. METHODS AND RESULTS: This was a prospective observational cohort study. From September 2005 to September 2007, 100 patients were referred for PAVR of whom 39 underwent PAVR, 14 surgical valve replacement (AVR) and three balloon valvuloplasty (PABV). Another 16 refused treatment and 28 were no candidate (non severe aortic stenosis [n=11], asymptomatic and normal ventricular function [n=3], comorbidity [n=12], technically PAVR not feasible [n=2]). The logistic EuroSCORE (Mean, sd) was: 15 +/- 6% (PAVR), 9 +/- 11% (AVR), 22 +/- 15% (PABV), 25 +/- 14% (refusals) and 17 +/- 12% (no-candidate). The mean follow-up was 13 months (range 0-30 months). Cumulative survival at six months was 97%, 85% and 70%, for PAVR, AVR and refusals, respectively. At 12 months, it was 87%, 62% and 40% respectively. CONCLUSIONS: Not all patients referred for PAVR finally receive it. Approximately 15% of the patients received AVR and 30% were considered not eligible. This may reflect the lack of sufficient data and need for an improvement in the technology in order to offer PAVR to both lower and higher risk patients. Considering risk and outcome, it is conceivable that patients who refused treatment could have benefited the most from it.

Early echocardiographic evaluation following percutaneous implantation with the self-expanding CoreValve Revalving System aortic valve bioprosthesis.

AIMS: Although safety and feasibility studies have been published, there are few reports dedicated to the echocardiographic evaluation of patients following percutaneous aortic valve replacement (PAVR). This report describes the early echocardiographic evaluation of patients undergoing PAVR with the CoreValve Revalving System. METHODS AND RESULTS: The population consisted of 33 consecutive patients with aortic stenosis who underwent successful PAVR. Echocardiograms were performed pre-treatment (123+/-110 days prior), post-treatment (6+/-2 days) and post-discharge (80+/-64 days). Aortic valve function and left ventricular dimensions, systolic and diastolic function were assessed pre- and post-implantation. The mean age was 81+/-7 years and the mean Logistic Euroscore was 20+/-12. Following PAVR, the mean transaortic valve gradient decreased (46+/-16 mmHg pre-treatment vs. 12+/-7 mmHg post-treatment vs. 9+/-5 mmHg post-discharge, p<0.001) and the mean effective orifice area increased (0.75+/-0.23 cm2 pre-treatment vs. 1.97+/-0.85 cm2 post-treatment vs. 1.72+/-0.45 cm2 post-discharge, p<0.001). There was no significant change in mean ejection fraction (41+/-12% pre-treatment vs. 46+/-15% post-treatment vs. 44+/-13% post-discharge, p=0.44). Approximately two-thirds of patients had no change in diastolic function at follow-up. CONCLUSION: Following implantation, there was a sustained decrease in aortic valve gradient and increase in aortic valve area. In addition, the mean ejection fraction did not change significantly and in the majority of patients, diastolic function was unchanged.