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.

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.

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.