Maayan Konigstein

The Obesity Paradox in Patients Undergoing Transcatheter Aortic Valve Implantation

Obesity is a major risk factor for cardiovascular morbidity and mortality. A considerable number of studies, however, showed better outcomes for overweight patients undergoing cardiovascular interventions—the so called obesity paradox.

Transcatheter treatment for refractory angina with the Coronary Sinus Reducer.

AIMS To evaluate the clinical efficacy of the coronary sinus (CS) Reducer in attenuating angina severity in patients suffering from severe refractory angina. METHODS AND RESULTS Patients with refractory angina, objective evidence of myocardial ischaemia and no option for revascularisation were treated with CS Reducer implantation at two medical centres. Six-month follow-up evaluation consisted of clinical assessment of angina severity. Objective assessment of ischaemia at six-month follow-up was performed in one of the two centres. Successful CS Reducer implantation was achieved in 21 of 23 eligible patients, at both centres. No device-related adverse effects were observed during the procedure or the follow-up period. Canadian Cardiovascular Society (CCS) score diminished from a mean of 3.3 at baseline to 2.0 at six months (n=20, p<0.01), exercise duration was prolonged from 3:16 to 5:16 min (min:sec; n=8, p=0.05). Thallium SPECT summed stress score and summed difference score were both reduced (n=9, 21.5±10 vs.13.2±9, p=0.01, and 11.1±6 vs. 4.7±4, p=0.007, respectively). Wall motion score index at peak dobutamine infusion was also significantly improved (n=8, 1.9±0.4 vs. 1.4±0.4, p=0.046). CONCLUSIONS CS Reducer implantation was safe and resulted in significant improvement of angina class. The results of the ongoing randomised sham-control trial will address the concern regarding the possible placebo effect, and hopefully further support our encouraging observations.

Comparison of Outcomes in Patients ≤85 Versus >85 Years of Age Undergoing Transcatheter Aortic-Valve Implantation

The impact of age on baseline characteristics and outcomes in patients with severe aortic stenosis who undergo transcatheter aortic valve implantation (TAVI) has not been thoroughly investigated. To describe the baseline clinical profile of TAVI patients aged >85 and ≤85 years and to evaluate the influence of age differences on outcomes, we evaluated a consecutive cohort of 293 patients who underwent transfemoral TAVI at the Tel Aviv Medical Center. The cohort was divided into 2 groups: patients aged >85 years (n = 93) and patients aged ≤85 years (n = 200). Mean age was 83 ± 5.3 years (range 63 to 98) for the entire cohort. Women comprised 70% of the older group and 57.5% of the younger age group (p = 0.043). Baseline clinical profile, including EuroSCORE index and preprocedural aortic valve area were similar in both age groups. Thirty-day mortality, major vascular complications, need for permanent pacemaker implantation, length of hospital stay, and improvement in functional class after the procedure showed no differences between the 2 groups. Adjustment for baseline clinical differences between groups did not change the results. In conclusion, among patients who underwent transfemoral TAVI, older patients (>85 years) experience similar benefits and outcomes regarding functional status, complication rates, and 30-day mortality.

Drug-induced Brugada syndrome: Clinical characteristics and risk factors

BACKGROUND Cardiac arrest may result from seemingly innocuous medications that do not necessarily have cardiac indications. The best-known example is the drug-induced long QT syndrome. A less known but not necessarily less important form of drug-induced proarrhythmia is the drug-induced Brugada syndrome. OBJECTIVE The purpose of this study was to identify clinical and ECG risk markers for drug-induced Brugada syndrome. METHODS Reports of drug-induced Brugada syndrome recounted by an international database (http://www.brugadadrugs.org) were reviewed to define characteristics that identify patients prone to developing this complication. For each patient with drug-induced Brugada syndrome who had an ECG recorded in the absence of drugs, we included 5 healthy controls matched by gender and age. All ECGs were evaluated for Brugada-like abnormalities. RESULTS Seventy-four cases of drug-induced Brugada syndrome from noncardiac medications were identified: 77% were male, and drug toxicity was involved in 46%. Drug-induced Brugada syndrome from oral medications generally occurred weeks after the initiation of therapy. Mortality was 13%. By definition, all cases had a type I Brugada pattern during drug therapy. Nevertheless, their ECG in the absence of drugs was more frequently abnormal than the ECG of controls (56% vs 33%, P = .04). CONCLUSION Drug-induced Brugada syndrome from noncardiac drugs occurs predominantly in adult males, is frequently due to drug toxicity, and occurs late after the onset of therapy. Minor changes are frequently noticeable on baseline ECG, but screening is impractical because of a prohibitive false-positive rate.

Forced diuresis with matched hydration in reducing acute kidney injury during transcatheter aortic valve implantation (Reduce-AKI): study protocol for a randomized sham-controlled trial

BackgroundAcute kidney injury (AKI) is observed in up to 41% of patients undergoing transcatheter aortic valve implantation (TAVI) and is associated with increased risk for mortality. The aim of the present study is to evaluate whether furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system reduces AKI in patients undergoing TAVI.Methods/DesignReduce-AKI is a randomized sham-controlled study designed to examine the effect of an automated matched hydration system in the prevention of AKI in patients undergoing TAVI. Patients will be randomized in a 1:1 fashion to the RenalGuard system (active group) versus non-matched saline infusion (sham-controlled group). Both arms receive standard overnight saline infusion and N-acetyl cysteine before the procedure.DiscussionThe Reduce-AKI trial will investigate whether the use of automated forced diuresis with matched saline infusion is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVI.Trial registrationClinicaltrials.gov: NCT01866800, 30 April 30 2013.

Impact of Carotid Atherosclerosis on the Risk of Adverse Cardiac Events in Patients With and Without Coronary Disease

Background and Purpose— Carotid atherosclerosis (CA) is reportedly a strong predictor of imminent cardiac events even in the absence of established coronary artery disease (CAD). We examined the differential impact of CA on the risk of major adverse cardiovascular events in patients with and without CAD diagnosed angiographically. Methods— We conducted a follow-up survey of 1391 patients who underwent clinically driven coronary angiography and a same-day carotid ultrasound and Doppler study. Definitions of CAD, CA, and carotid artery stenosis were in accordance with current practice guidelines. Results— Of 1391 patients, angiographic CAD was present in 1105 (79%) patients. Mean and median follow-up was 1574 and 1702 days, respectively. Rates of the primary composite major adverse cardiovascular event end point were higher among patients with CAD compared with those without CAD (48% versus 20%; P<0.001), whereas the rates of all-cause mortality (10% versus 9%; P=0.81) and stroke (7% versus 5%; P=0.3) did not differ significantly between both groups. Carotid artery stenosis and CA were associated with an increased risk of the composite major adverse cardiovascular event end point among patients without CAD (hazard ratio=3.17 [95% confidence interval, 1.52–6.60]; P<0.01; and hazard ratio=1.69 [0.95–3.01]; P=0.07, respectively) though not in patients with CAD. Carotid artery stenosis was associated with an increased risk of all-cause mortality among patients without CAD (hazard ratio=2.93 [1.09–7.87]; P=0.03]) though not among those with CAD. Conclusions— CA and carotid artery stenosis are independent predictors of major adverse cardiovascular event in patients undergoing coronary angiography. The prognostic implications of carotid disease are imparted predominantly in patients without pre-existent CAD.

Prevention of post procedural acute kidney injury in the catheterization laboratory in a real-world population.

BACKGROUND Radiologists and cardiologists have a remarkably different approach to the clinical importance and to the need for prophylactic treatment of contrast-induced acute kidney injury (CI-AKI). OBJECTIVES To evaluate the efficacy of forced diuresis with matched controlled hydration (FMH) in a real-world, high risk population. METHODS This is an investigator-driven, single-center, retrospective analysis of prospectively collected data. A total of 150 consecutive patients undergoing coronary angiography, angioplasty or TAVR who were treated with FMH were compared to a matched historical control cohort. RESULTS In the FMH treated patients, eGFR improved following the procedure from 37ml/min per 1.73m2 at baseline to 39ml/min per 1.73m2 (p<0.001); the net creatinine decreased from 1.85mg/dl to 1.78mg/dl (p<0.001). Among the matched control group, eGFR deteriorated from a baseline value of 36.7ml/min per 1.73m2 to 33.2ml/min per 1.73m2 post procedurally (p<0.001); the net creatinine increased from 1.88mg/dl to 2.14mg/dl (p<0.001). The incidence of post procedural AKI was substantially lower in the FMH treated group (2.7%) compared to the control group (26.7%). By multivariable analysis FMH treatment was independently correlated with reduced incidence of post procedural AKI compared with the control group (OR 0.06, p<0.001). Contrast volume did not correlate with AKI in neither univariate nor multivariate analyses. CONCLUSIONS In patients undergoing coronary angiography, angioplasty or TAVR, who are considered high risk to develop post procedural AKI, forced diuresis with matched controlled hydration resulted in a significant net creatinine decrease, eGFR increase and a decrease in the incidence of AKI.

Norton scale for predicting prognosis in elderly patients undergoing trans-catheter aortic valve implantation: A historical prospective study

BACKGROUND The Norton scale is traditionally used to assess the risk of pressure ulcers. However, recent studies have shown its prognostic utilization in elderly patients with diverse medical conditions. The association between low admission Norton scale scores (ANSS), complications, and mortality in elderly patients following trans-catheter aortic valve implantation (TAVI) has never been studied. We aimed to determine if low ANSS (≤16) is associated with complications and 30-day and 1-year mortality in elderly patients undergoing TAVI. METHODS The medical charts of elderly (≥70 years) TAVI patients at the Tel-Aviv Medical Center, a tertiary medical center, were studied for the following measurements: ANSS, demographics, co-morbidities, complications during hospitalization, and 30-day and 1-year mortality. Complications included: an atrio-ventricular block, stroke, and vascular complications. RESULTS The cohort included 302 elderly patients: 179 (59.3%) were women; the mean age was 83.3±5.1 years. Following TAVI, 112 (37.1%) patients had complications other than pressure ulcers, 10 (3.3%) patients died within 30 days, and 42 (13.9%) patients died within one year. Overall, 36 (11.9%) patients had low ANSS. 1-year mortality rates were almost three times higher in patients with low ANSS relative to patients with high ANSS (27.8% vs. 12.0%; the relative risk 1.1; p=0.018). A stepwise logistic regression analysis showed that ANSS was independently inversely associated with 1-year mortality (p=0.018). Complications and 30-day mortality rates were similar in both groups. CONCLUSIONS Low ANSS are associated with 1-year mortality after TAVI. The Norton scale may therefore be used as an additional tool for elderly patient selection before TAVI.

HbA1c Levels and Long-Term Mortality in Patients Undergoing Coronary Angiography

Objectives: Previous studies investigating the prognostic value of HbA1c in patients undergoing coronary angiography reported a mixed pattern of results. Therefore, we aimed to better define the prognostic power of HbA1c among coronary catheterized patients. Methods: Patients undergoing coronary angiography (n = 3,749) were divided into four groups according to HbA1c levels (<5, 5-6, 6-7 and >7%). Cox regression models assessed long-term mortality after adjusting for multiple covariates. Results: Baseline clinical profiles differed in HbA1c groups, with a higher prevalence of comorbidities in the groups with higher HbA1c levels. Median follow-up was 1,745 days (interquartile range 1,007-2,171). A J-shaped association curve was observed between HbA1c levels and all-cause mortality rates, with patients in the lowest and highest HbA1c groups suffering from significantly higher mortality rates compared to in-between groups (hazard ratio 1.9, 95% CI 1.32-2.74, p = 0.001, and hazard ratio 1.58, 95% CI 1.29-1.95, p < 0.001, for the lowest and highest HbA1c groups, respectively). This association persisted after adjustment for anemia, nutritional status, renal function, cardiovascular risk factors and inflammatory biomarkers. Conclusions: HbA1c levels <5 or >7% are predictors of all-cause mortality in patients undergoing coronary angiography.

Polymer-free drug-eluting stent in unselected patient population: A single center experience☆ , ☆☆ ,★

OBJECTIVE To evaluate the clinical performance of the Cre8™ polymer-free drug-eluting-stent in unselected real-life population. BACKGROUND Inflammation plays a key role in the multi-factorial process eventually leading to target vessel failure (TVF) after drug-eluting-stent (DES) implantation. The local chronic inflammatory reaction in the vessel wall at the site of stent implantation is, at least in part, attributed to interaction between the polymer coating of DES and vessel wall components. The belief that elimination of the polymer will reduce the occurrence of short and long-term TVF has led to the field of polymer-free DES development. METHODS AND RESULTS In this prospective, open-labeled, single-center, uncontrolled trial we enrolled consecutive patients undergoing PCI to receive the Cre8™ stent. The only exclusion criteria were in-stent restenosis and target vessel diameter <2.5mm. Primary end points were cardiac death and target vessel failure (TVF) at 1-year. Overall, 215 patients were enrolled, in which 318 Cre8 stents were implanted. Study population was characterized by a high prevalence of comorbidities including 38% of diabetics. More than 50% presented with acute coronary syndromes. During 1-year of follow-up there were 1 case of sudden death and 1 case of non-cardiac death, as well as 2 cases of TVF. CONCLUSION In this small single-center trial of unselected real-life population, the polymer-free Cre8™ DES appears to be effective, as it was associated with very low rates of target-vessel-failure up to 1-year follow-up.