Outcomes of Patients Undergoing PCI of Ostial Coronary Lesions: A Single-Center Study.

INTRODUCTION: Ostial coronary lesions are a subset of proximal coronary lesions, which are relatively more difficult to treat and were associated with worse clinical outcomes in the early percutaneous coronary intervention (PCI) era. Data regarding the outcomes of ostial lesions' PCI in the contemporary era are lacking. METHODS: We conducted a single-center, all-comer, prospective registry study, enrolling patients undergoing PCI with the use of contemporary drug-eluting stents (DES) between July 2016 and February 2018. Included in the present analysis were only patients treated for proximal lesions. Clinical outcomes were compared between patients undergoing PCI of ostial versus proximal nonostial lesions. The primary endpoint was target vessel revascularization (TVR). Secondary endpoints included target lesion revascularization (TLR) and major cardiovascular adverse events (MACE) at 12 months. RESULTS: A total of 334 (84.7% male, 67.3 ± 10.7 years) patients were included, of which 91 patients were treated for ostial lesions and 243 were treated for proximal nonostial lesions. Baseline and procedural characteristics were similar between the two groups. At 12 months, TVR and TLR were numerically higher among patients undergoing PCI of ostial versus nonostial lesions without reaching statistical significance (5.5% vs. 3.3%; p = 0.35 and 4.4% vs. 2.5%; p = 0.47, respectively). The rate of MACE was similar between the two groups. CONCLUSION: In patients undergoing PCI with the use of contemporary DES, clinical outcomes were similar among patients treated for ostial compared to proximal nonostial lesions. Larger studies are required to further evaluate the performance of contemporary DES in this subset of lesions.

Neutrophil-to-Lymphocyte Ratio as a Prognostic Marker in Transcatheter Aortic Valve Implantation (TAVI) Patients.

BACKGROUND: Neutrophil-to-lymphocyte ratio (NLR) is a simple and cost-effective marker of inflammation. This marker has been shown to predict cardiac arrhythmias, progression of valvular heart disease, congestive heart failure decompensation, acute kidney injury, and mortality in cardiovascular patients. The pathologic process of aortic stenosis includes chronic inflammation of the valve and therefore biomarkers of inflammation might offer additive prognostic value. OBJECTIVES: To evaluate NLR and its association with long term mortality in transcatheter aortic valve implantation (TAVI) patients. METHODS: We evaluated data of 1152 consecutive patient from the Tel Aviv Medical Center TAVI registry who underwent TAVI. Data included baseline clinical, demographic, and echocardiographic findings; procedural complications; and post-procedure mortality. Patients were compared by using the median NLR value (4.1) and evaluated for long-term mortality. RESULTS: Patients with NLR above the median had higher mortality rates (26.4% vs. 16.3%, P < 0.001) at 3 years post-procedure. A multivariable analysis found NLR to be an independent risk factor for mortality (hazard ratio = 1.47, 95% confidence interval 1.09-1.99, P = 0.013). In addition, high NLR was linked to complicationsduring and after the procedure. CONCLUSIONS: NLR is an independent prognostic marker among TAVI patients. This marker may represent an increased inflammatory response and should be added to previous known prognostic factors.

Impact of preprocedural left ventricle hypertrophy and geometrical patterns on mortality following TAVR.

BACKGROUND: In contrast to surgical aortic valve replacement, left ventricle (LV) hypertrophy (LVH) had not been clearly associated with mortality following transcatheter aortic valve replacement (TAVR). METHODS: We performed a retrospective analysis of patients enrolled in the Israeli multicenter TAVR registry for whom preprocedural LV mass index (LVMI) data were available. Patients were divided into categories according to LVMI: normal LVMI and mild, moderate, and severe LVH. Mild LVH was regarded as the reference group. Additionally, LV geometry patterns were examined (concentric and eccentric LVH, and concentric remodeling). RESULTS: The cohort consisted of 1,559 patients, 46.5% male, with a mean age of 82.2 (±6.8) years and mean LVMI of 121 (±29) g/m2. Rates of normal LVMI and mild, moderate, and severe LVH were 31% (n = 485), 21% (n = 322), 18% (n = 279), and 30% (n = 475), respectively. Three-year mortality rates for normal LVMI and mild, moderate, and severe LVH were 19.8%, 18.3%, 23.7%, and 24.4%, respectively. Compared to mild LVH, moderate LVH and severe LVH were independently associated with an increased risk for all-cause mortality (hazard ratio [HR] 1.58, 95% CI 1.15-2.18, P = .005; HR 1.46, 95% CI 1.1-1.95, P = .009; respectively). Concentric LVH was independently associated with a decreased risk for mortality compared to normal LV geometry (HR 0.75, 95% CI 0.63-0.89, P = .001). Compared to concentric LVH, eccentric LVH was independently associated with a 33% increased risk for mortality (HR 1.33, 95% CI 1.11-1.60, P = .002). CONCLUSIONS: Mild concentric LVH confers a protective effect among patients with severe aortic stenosis undergoing TAVR. However, hypertrophy becomes maladaptive, and an increased baseline LVMI, eccentric pattern particularly, may be associated with all-cause mortality in this population.

Acute kidney injury after transcatheter aortic valve implantation and mortality risk-long-term follow-up.

BACKGROUND: Acute kidney injury (AKI) complicating transcatheter aortic valve implantation (TAVI) is relatively frequent and associated with significant morbidity. Previous studies have shown a higher 30-day and 1-year mortality risk in patients with periprocedural AKI. Our aim was to identify the prognostic impact of periprocedural AKI on long-term follow-up. METHODS: This is a single-center prospective study evaluating patients undergoing TAVI for severe aortic stenosis. AKI was defined according to the Valve Academic Research Consortium 2 definition, as an absolute increase in serum creatinine ≥0.3 mg/dL or an increase >50% within the first week following TAVI. Mortality data were compared between patients who developed AKI and those who did not. Logistic and Cox regressions were used for survival analysis. RESULTS: The final analysis included 1086 consecutive TAVI patients. AKI occurred in 201 patients (18.5%). During the follow-up period, 289 patients died. AKI was associated with an increased risk of 30-day mortality {4.5 versus 1.9% in the non-AKI group; hazard ratio [HR] 3.70 [95% confidence interval (CI) 1.35-10.13]}. Although 1-year mortality was higher in the AKI group in univariate analysis, it was not significant after a multivariate regression. AKI was a strong predictor of longer-term mortality [42.3 versus 22.7% for 7-year mortality; HR 1.71 (95% CI 1.30-2.25)]. In 189 of 201 patients we had data regarding recovery from AKI up to 30 days after discharge. In patients with recovery from AKI, the mortality rate was lower (38.2 versus 56.6% in the nonrecovery group; P = 0.022). CONCLUSIONS: Periprocedural AKI following TAVI is a strong risk factor for short-term as well as long-term mortality (up to 7 years). Therefore more effort is needed to reduce this complication.

Forced diuresis with matched hydration during transcatheter aortic valve implantation for Reducing Acute Kidney Injury: a randomized, sham-controlled study (REDUCE-AKI).

AIMS: Acute kidney injury (AKI) is a common complication following transcatheter aortic valve implantation (TAVI) and is associated with increased risk for short- and long-term mortality. In patients undergoing percutaneous coronary intervention (PCI), forced diuresis with matched hydration has been shown to reduce the incidence of AKI by ∼50%. The aim of the present study was to evaluate whether forced diuresis with matched intravenous hydration reduces AKI in patients undergoing TAVI. METHODS AND RESULTS: Reducing Acute Kidney Injury (REDUCE-AKI) was a single-centre, prospective, randomized, double-blind sham-controlled clinical trial, designed to examine the effect of an automated matched saline infusion with urine output for the prevention of AKI in patients undergoing TAVI. A total of 136 TAVI patients were randomized, 68 in each group. Mean age was 83.9 ± 5 years and 41.2% were males. There were no differences in baseline characteristics between the two groups. The rate of AKI was not statistically different between the groups (25% in the active group vs. 19.1% in the sham group, P = 0.408). There was a significant increase in long-term mortality in the active group (27.9% vs. 13. 2% HR 3.744, 95% CI 1.51-9.28; P = 0.004). The study was terminated prematurely by the Data Safety Monitoring Board for futility and a possible signal of harm. CONCLUSIONS: Unlike in PCI, forced diuresis with matched hydration does not prevent AKI in patients undergoing TAVI, and might be associated with increased long-term mortality. Future studies should focus on understanding the mechanisms behind these findings. CLINICALTRIALS.GOV REGISTRATION: NCT01866800, 30 April 2013.

Safety outcomes of new versus old generation transcatheter aortic valves.

OBJECTIVE: To compare procedural outcomes of transcatheter aortic valve implantation (TAVI) patients who were implanted with older versus newer generation valves. BACKGROUND: The current evidence base for improved safety of the newer commercially available TAVI valves is limited. METHODS: A retrospective analysis of the Israeli multicenter TAVI registry was performed. Patients were stratified by valve generation of four commercially available devices: Edwards Sapien (ESX) Edwards Sapien S3 (ES3), Medtronic CoreValve (MCV), and Medtronic Evolut R (MER). RESULTS: The cohort consisted of 737 patients with new generation valves (NGVs; ES3 n = 223; MER n = 514) and 1,869 with old generation valves (OGVs; MCV n = 1,181; ESX n = 688). Device success rates were significantly higher in NGV (97.5 versus 95.4%), with less post-procedural paravalvular leak (3 versus 5.8%), and valve mal-positioning (1.2 versus 3.4%); all P-values<0.05. There were no differences in rates of permanent pacemaker implantation, stroke or acute kidney injury (AKI) of any stage between the groups, although stage ≥2 AKI was more prevalent in NGV. After adjustment to significant differences in baseline patient and procedural characteristics, device success was higher (OR 1.86, 95% confidence interval (CI) 1.09-3.18, P = 0.023) and the 1-month safety outcome was significantly lower (OR 0.72, 95% CI 0.55-0.96, P = 0.025) for NGV. Device success was driven mainly by improved rates of PVL of ES3, while the safety outcome was mainly driven by improved rates of life-threatening bleeding and valve mal-positioning of MER. CONCLUSION: As compared to OGV, use of NGV for TAVI was associated with higher rates of device success and lower rates of adverse events.

First-Phase Ejection Fraction and Long-Term Survival in Patients Who Underwent Transcatheter Aortic Valve Implantation.

Early recognition of deteriorating left ventricular function plays a key prognostic role in patients with aortic stenosis (AS). First-phase ejection fraction (EF1), the ejection fraction (EF) up to time of maximal contraction, has been suggested for detection of early left ventricular dysfunction in patients with AS with preserved EF. This work aims to evaluate the predictive value of EF1 for assessment of long-term survival in patients with symptomatic severe AS and preserved EF who undergo transcatheter aortic valve implantation (TAVI). We included 102 consecutive patients (median age 84 years [interquartile range 80 to 86 years]) who underwent TAVI between 2009 and 2011. Patients were retrospectively stratified into tertiles by EF1. Device success and procedural complications were defined according to the Valve Academic Research Consortium-3 criteria. Mortality data were retrieved from a computerized interface of the Israeli Ministry of Health. Baseline characteristics, co-morbidities, clinical presentation, and echocardiographic findings were similar among groups. The groups did not differ significantly regarding device success and in-hospital complications. During a potential follow-up period of >10 years, 88 patients died. Kaplan-Meier analysis (log-rank p = 0.017) followed by multivariable Cox regression analysis showed that EF1 predicted long-term mortality independently, either as continuous variable (hazard ratio 1.04, 95% confidence interval 1.01 to 1.07, p = 0.012) or for each decrease in tertile group (hazard ratio 1.40, 95% confidence interval 1.05 to 1.86, p = 0.023). In conclusion, low EF1 is associated with a significant decrease in adjusted hazard for long-term survival in patients with preserved EF who undergo TAVI. Low EF1 might delineate a population at great risk who would benefit from prompt intervention.

Vascular Complications in Transcatheter Aortic Valve Replacement With Plug-Based vs Suture-Based Closure Devices.

BACKGROUND: There are conflicting data regarding the efficacy and safety of suture vs plug-based vascular closure devices (VCDs) for large-bore catheter management in patients undergoing transcatheter aortic valve replacement (TAVR). We compared the rates of vascular complications (VCs) associated with 2 commonly used VCDs in a large cohort of patients undergoing TAVR. METHODS: We conducted a single-centre, all-comer, prospective registry study, enrolling patients undergoing TAVR for symptomatic severe aortic stenosis (AS) between the years 2009 and 2022. Clinical outcomes were compared between patients undergoing closure of the femoral access point using the MANTA VCD (M-VCD) (Teleflex, Wayne, PA) vs the ProGlide VCD (P-VCD) (Abbott Vascular, Abbott Park, IL). The main outcome measures were researcher adjudicated events of VARC-2 defined major and minor VCs. RESULTS: Overall, 2368 patients were enrolled in the registry; 1315 (51.0% male, 81.0 ± 7.0 years) patients were included in the current analysis. P-VCD was used in 813 patients, whereas M-VCD was used in 502 patients. In-hospital VCs were more frequent in the M-VCD vs the P-VCD group (17.3% vs 9.8%; P < 0.001). This outcome was mainly driven by elevated rates of minor VCs in the M-VCD group, whereas no significant difference was observed for major VCs (15.1% vs 8.4%; P < 0.001 and 2.2% vs 1.5%; P = 0.33, respectively). CONCLUSIONS: In patients undergoing TAVR for severe AS, M-VCD was associated with higher rates of VCs. This outcome was mainly driven by minor VCs. The rate of major VCs was low in both groups.

Long-term Implications of Post-Procedural Left Ventricular End-Diastolic Pressure in Patients Undergoing Transcatheter Aortic Valve Implantation.

Current risk models have only limited accuracy in predicting transcatheter aortic valve Implantation (TAVI) outcomes and there is a paucity of clinical variables to guide patient management after the procedure. The prognostic impact of elevated left ventricular end-diastolic pressure (LVEDP) in TAVI patients is unknown. The aim of the present study was to evaluate the prognostic value of after-procedural LVEDP in patients who undewent TAVI. Consecutive patients with severe symptomatic aortic stenosis who undewent TAVI were divided into 2 groups according to after-procedural LVEDP above and below or equal 12 mm Hg. Collected data included baseline clinical, laboratory and echocardiographic variables. We evaluated the impact of elevated vs. normal LVEDP on in-hospital outcomes, short- and long-term mortality. Eight hundred forty-five patients were included in the study with complete in-hospital and late mortality data available for all survivors (median follow-up 29.5 months [IQR 16.5 to 48.0]). The mean age (±SD) was 82.3±6.2 years and mean Society of Thoracic Surgery score was 4.0%±3.0%. Patients with LVEDP>12 mm Hg (n = 591, 70%) and LVEDP≤12 mm Hg (n = 254, 30%) had a 6-months mortality rate of 6.8% and 2%, respectively (P=0.004) and a 1-year mortality rate of 10.1% vs 4.9%, respectively (p = 0.017). By multivariable analysis, after-procedural LVEDP>12 mm Hg was independently associated with all-cause mortality (HR 2.45, 95% CI 1.58 to 3.76, p <0.001) during long-term follow-up. In conclusion, elevated after-procedural LVEDP in patients who undewent TAVI is an independent predictor of mortality following TAVI. Further research regarding the use of LVEDP as a tool for after-procedural medical management is warranted.

Assessment of Kidney Function After Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR), although associated with an increased risk for acute kidney injury (AKI), may also result in improvement in renal function. OBJECTIVE: The aim of this study is to evaluate the magnitude of kidney function improvement (KFI) after TAVR and to assess its significance on long-term mortality. DESIGN: This is a prospective single center study. SETTING: The study was conducted in cardiology department, interventional unit, in a tertiary hospital. PATIENTS: The cohort included 1321 patients who underwent TAVR. MEASUREMENTS: Serum creatinine level was measured at baseline, before the procedure, and over the next 7 days or until discharge. METHODS: Kidney function improvement was defined as the mirror image of AKI, a reduction in pre-procedural to post-procedural minimal creatinine of more than 0.3 mg/dL, or a ratio of post-procedural minimal creatinine to pre-procedural creatinine of less than 0.66, up to 7 days after the procedure. Patients were categorized and compared for clinical endpoints according to post-procedural renal function change into 3 groups: KFI, AKI, or preserved kidney function (PKF). The primary endpoint was long-term all-cause mortality. RESULTS: The incidence of KFI was 5%. In 55 out of 66 patients patients, the improvement in kidney function was minor and of unclear clinical significance. Acute kidney injury occurred in 19.1%. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 was a predictor of KFI after multivariable analysis (odds ratio = 0.93 to develop KFI; confidence interval [95% CI]: 0.91-0.95, P < .001). Patients in the KFI group had a higher Society of Thoracic Surgery (STS) score than other groups. Mortality rate did not differ between KFI group and PKF group (43.9% in KFI group and 33.8% in PKF group) but was significantly higher in the AKI group (60.7%, P < .001). LIMITATIONS: The following are the limitations: heterozygous definitions of KFI within different studies and a single center study. Although data were collected prospectively, analysis plan was defined after data collection. CONCLUSIONS: Improvement in kidney function following TAVR was not a common phenomenon in our cohort and did not reduce overall mortality rate.

CONTEXTE: L'implantation transcathéter de valvule aortique (ITVA), bien qu'elle soit associée à un risque accru d'insuffisance rénale aiguë (IRA), est susceptible d'améliorer la fonction rénale. OBJECTIFS: Évaluer l'ampleur de l'amélioration de la fonction rénale (AFR) après une ITVA et évaluer son incidence sur le taux de mortalité à long terme. TYPE D'ÉTUDE: Étude prospective menée dans un seul centre hospitalier. CADRE: Le service de cardiologie, unité interventionnelle, d'un centre de soins tertiaires. SUJETS: La cohorte était constituée de 1 321 patients ayant subi une ITVA. MESURES: Le taux de créatinine sérique a été mesuré à l'inclusion, avant l'intervention et pour les 7 jours suivants, ou jusqu'au congé du patient. MÉTHODOLOGIE: L'AFR a été définie comme l'image miroir de l'IRA, soit une réduction de plus de 0,3 mg/dl du taux de créatinine après l'intervention par rapport au taux minimum de créatinine mesuré pré-ITVA, ou un rapport entre la créatinine minimale post-ITVA et la créatinine pré-ITVA inférieur à 0,66 jusqu'à 7 jours après l'intervention. Les patients ont été classés en trois groupes et comparés selon des critères cliniques en fonction de la modification de la fonction rénale après l'intervention : un groupe AFR, un groupe IRA et un groupe « fonction rénale préservée ¼ (FRP). Le critère principal était la mortalité toutes causes confondues. RÉSULTATS: L'incidence d'une AFR était de 5 % et elle s'est avérée mineure et d'importance clinique incertaine pour 55 des 66 patients concernés. La proportion de patients atteints d'IRA était de 19,1 %. Après l'analyse multivariée, un débit de filtration glomérulaire estimé (DFGe) inférieur à 60 ml/min/1,73 m2 s'est avéré un facteur prédictif de l'AFR [rapport de cotes pour une AFR : 0,93 (IC : 0,91-0,95; p < 0,001)]. Les patients du groupe AFR présentaient un score de la Society of Thoracic Surgery (STS) plus élevé que ceux des autres groupes. Le taux de mortalité était similaire pour les groupes AFR et FRP (respectivement 43,9 % et 33,8 %), mais s'est avéré significativement plus élevé dans le groupe IRA (60,7 %; p < 0,001). LIMITES: Manque de consensus autour de la définition d'une amélioration de la fonction rénale dans les différentes études.Étude menée dans un seul centre.Bien que les données aient été recueillies de façon prospective, le plan d'analyse n'a été défini qu'après la collecte des données. CONCLUSION: L'amélioration de la fonction rénale après l'ITVA n'était pas un phénomène courant dans notre cohorte et n'a pas permis de réduire le taux de mortalité global.

The impact of normal range estimated glomerular filtration rate on mortality in selected patients undergoing coronary angiography - a long-term follow-up.

BACKGROUND: Estimated glomerular filtration rate (eGFR) predicts mortality and adverse cardiovascular events in people with chronic kidney disease. The significance of eGFR within the normal range and its long-term effect on clinical adverse events is unknown. We examined the effect of normal range or mildly reduced eGFR on long-term mortality in a large prospective registry. METHODS: The study included consecutive patients undergoing clinically-driven coronary angiography who had an eGFR ≥60 ml/min/1.73 m2. Baseline clinical characteristics were assessed, and patients were followed-up for the occurrence of all-cause mortality. Cox regression analysis was used to evaluate the impact of eGFR. RESULTS: A total of 4186 patients were recruited. Median follow-up time was 2883 days (7.9 years). Mean age was 62.0 ± 11.3 years with 77.4% males. Clinical presentation included acute coronary syndrome and stable angina. In a multivariable model adjusted for possible confounding factors, decreasing eGFR within the normal and mildly reduced range was inversely associated with long-term all-cause mortality with a hazard ratio (HR) of 1.32 for every decrease of 10 ml/min/1.732 in eGFR. Compared to eGFR > 100 ml/min/1.732, there was a graded association between lower eGFR values and increased long term mortality with a HR of 1.16 (0.59-2.31) for eGFR 90-100 ml/min/1.732, HR 1.54 (0.81-2.91) for eGFR 80-90 ml/min/1.732, HR 2.62 (1.41-4.85) for eGFR 70-80 ml/min/1.732 and HR 2.93 (1.58-5.41) for eGFR 60-70 ml/min/1.732. CONCLUSION: eGFR within the normal and mildly reduced range is an independent predictor of long-term all-cause mortality in selected patients undergoing clinically driven coronary angiography.

Comparative efficacy analysis of an aspiration device before primary angioplasty in patients with acute myocardial infarction: a single-center experience.

BACKGROUND: ST-elevation myocardial infarction is caused by occlusive coronary thrombosis where antecedent plaque disruption occurs. When treating STEMI the main goal is to achieve prompt reperfusion of the infarction area. Several studies have demonstrated the efficacy of an aspiration device before percutaneous coronary intervention in patients with acute myocardial infarction. OBJECTIVES: To determine the added value of thrombus aspiration prior to primary PCI by comparing AMI patients with totally occluded infarct-related artery treated with routine primary PCI to those treated with extraction device prior to primary PCI. METHODS: The study group comprised 122 consecutive patients with AMI and a totally occluded infarct artery (TIMI flow 0) who underwent primary PCI. The patients were divided into two groups: 68 who underwent primary PCI only (control group) and 54 who underwent primary thrombus extraction with an extraction device before PCI (extraction group). Baseline clinical and lesion characteristics were similar in both groups. Final TIMI grade flow and myocardial blush as well as 1 year mortality, target lesion revascularization, recurrent myocardial infarction, unstable angina and stroke were compared between the two groups. RESULTS: Primary angiographic results were better for the extraction group versus the control group: final grade 3 TIMI flow was 100% vs. 95.6% (P= 0.03) and final grade 3 myocardial blush grade 50% vs. 41.18% (although Pwas not significant). Long-term follow-up total MACE showed a nonsignificant positive trend in the extraction group (12.96% vs. 24.71%, P= 0.26). CONCLUSIONS: The use of extraction devices for intracoronary thrombectomy during primary PCI in patients with totally occluded infarct artery significantly improved epicardial reperfusion in the infarct-related vessel and showed a trend for more favorable long-term outcome.

The impact of coronary sinus narrowing on diastolic function in patients with refractory angina.

OBJECTIVE: Evaluating the impact of Coronary sinus (CS) narrowing on diastolic function. BACKGROUND: Narrowing of the CS is an emerging therapy for refractory angina pectoris, improving perfusion to the ischemic subendocardium and relieving ischemia and angina. It was speculated that increased CS pressure might cause interstitial myocardial edema and diastolic dysfunction. METHODS: Prospective assessment of diastolic function was performed at baseline and 6 months following CS Reducer implantation in consecutive patients treated for refractory angina. Diastolic function assessment included left atrial volume, early transmitral filling peak velocity (E wave), E wave deceleration time (DT), transmitral atrial wave velocity (A wave), and early diastolic velocity of the septal (e' septal) and lateral (e' lateral) aspects of the mitral annulus. RESULTS: Twenty-four patients with chronic refractory angina and proven myocardial ischemia (mean age 69.3 ±â€¯10.9 years) were included in the analysis. A wave velocity, E/A ratio, E wave DT and left atrial volume did not significantly change 6 months following Reducer implantation (p > 0.1 for all comparisons). A non-significant decrease in E wave velocity (80.5 ±â€¯22.3 cm/s vs. 75.7 ±â€¯17.5 cm/s, p = 0.19) and non significant increase in e' septal and lateral (5.28 ±â€¯1.54 cm/s vs. 5.30 ±â€¯1.71 cm/s, p = 0.95 and 8.26 ±â€¯1.85 cm/s vs. 8.46 ±â€¯2.07 cm/s, p = 0.69, respectively) led to a non-significant decrease in E/e' average ratio (12.6 ±â€¯5.7 vs. 11.4 ±â€¯3.3, p = 0.24). Mean diastolic function class significantly decreased following Reducer implantation from 1.5 ±â€¯0.66 to 1.17 ±â€¯0.76 (p = 0.008). CONCLUSION: Coronary sinus narrowing in patients with myocardial ischemia and refractory angina does not adversely affect diastolic function and may actually improve it.

Prognostic Implications of Baseline Pulmonary Vascular Resistance Determined by Transthoracic Echocardiography Before Transcatheter Aortic Valve Replacement.

BACKGROUND: Elevated pulmonary vascular resistance (PVR) determined using right heart catheterization portends an adverse prognosis following transcatheter aortic valve replacement (TAVR). The prognostic role of preprocedural PVR determined noninvasively using transthoracic echocardiography has not been studied in the TAVR setting. METHODS: Baseline clinical and echocardiographic variables from a prospective TAVR registry were analyzed to determine preprocedural PVR and its impact on late outcomes (all-cause mortality, stroke, readmission for heart failure, new-onset atrial fibrillation). Echocardiographic PVR was estimated by the ratio of peak tricuspid regurgitation velocity to the time-velocity integral of the right ventricular outflow tract. RESULTS: Ninety-seven patients were included in the study, with complete 3-year follow-up data available for all survivors. Mean PVR was 2.1 ± 0.) WU in the entire cohort and 2.7 ± 0.9 WU among patients with pulmonary hypertension. In the entire cohort, 29 patients (29.9%) died during the study period. Three-year all-cause mortality and composite adverse event rates were higher with increased versus normal PVR (55.6% vs 24.1% [P = .008] and 66.7% vs 41.8% [P = .06], respectively). By multivariate analysis, PVR as either a continuous (hazard ratio, 1.75; 95% CI, 1.1-2.81; P = .02) or a categorical (≥2.5 vs >2.5 WU; hazard ratio, 2.49; 95% CI, 1.09-5.71; P = .03) variable was independently associated with all-cause mortality. Although systolic pulmonary artery pressure was associated with all-cause mortality on univariate analysis, this association was not statistically significant on multivariate analysis accounting for PVR. CONCLUSIONS: PVR estimated using transthoracic echocardiography is an independent predictor of mortality at long-term follow-up after TAVR. Systolic pulmonary artery pressure was associated with increased late mortality, although this relation was not significant after adjustment for baseline variables and PVR.

Red blood cell distribution width as a prognostic factor in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Red blood cell distribution width (RDW), which is routinely reported in complete blood counts, is a measure of the variability in size of circulating erythrocytes. RDW is an independent predictor of prognosis in patients with cardiovascular diseases. We evaluated the short- and long-term prognostic value of RDW in a large cohort of transcatheter aortic valve implantation (TAVI) patients. METHODS: The impact of RDW on outcome was determined prospectively in 1029 consecutive patients with severe aortic stenosis (AS) undergoing transfemoral TAVI. The cohort was divided into 2 groups according to RDW above and below 15.5%. Collected data included patient characteristics, medical background, left ventricle ejection fraction (LVEF), frailty score, Society of Thoracic Surgeons (STS) score, periprocedural laboratory results, and long-term (up to 7.5 years) clinical outcomes. RESULTS: The mean age (±SD) was 83.1±6.3 years, mean STS score was 4.2±3.1% and mean estimated LVEF was 55.7±8.4%. Mean pre-TAVI RDW levels were 15.3±3.2%. Patients with RDW≤15.5% (n=683) and RDW>15.5% (n=346) had a 1-year mortality rate of 6% and 17%, respectively (p=0.001) and a 5-year mortality rate of 20% and 38%, respectively (p<0.001). Baseline RDW>15.5% was independently associated with all-cause mortality (hazard ratio 1.83, 95% confidence interval 1.44-2.32, p<0.001). CONCLUSIONS: Elevated RDW is a strong independent marker and predictor of short- and long-term mortality following TAVI, that might present a relevant future supplement to current preprocedural risk scores. Additional research is needed to clarify the mechanisms responsible for this finding.

Effect of Statin Therapy and Long-Term Mortality Following Transcatheter Aortic Valve Implantation.

Increased inflammatory response after aortic valve replacement is linked to higher postprocedural mortality. The aim of the present analysis was to assess the impact of baseline statin therapy on procedural outcomes and mortality after transcatheter aortic valve implantation (TAVI). We performed a retrospective analysis on patients who underwent TAVI stratified to 3 statin therapy groups: high-intensity statin (HIS), low-medium intensity statins, and no statin. Included were 1,238 patients. Patients treated with HIS were significantly younger, had higher body mass index, lower Society of Thoracic Surgeons score, and higher prevalence of dyslipidemia, hypertension, past stroke, and ischemic heart disease. Procedural outcomes were similar between groups. There were no statistically significant short-term mortality differences at 1 month (2.2% vs 2.1% vs 3.5%, p = 0.50) and 1 year (6.9% vs 9.3% vs 14.2%, p = 0.15), albeit the observed numerical trend. As for long-term mortality (median follow time of 2.5 years, interquartile range 1.3 to 4.2), lower mortality rates were observed in the HIS group (14.5% vs 25.2% vs 36.6%, p = 0.001). Compared with no statin, the HIS group was significantly associated with reduced risk of long-term mortality in multivariate analysis (hazard ratio = 0.59, 95% CI 0.37 to 0.96, p = 0.03). Baseline HIS therapy is associated with reduced rates of long-term morality after TAVI.

Outcomes of Transcatheter Aortic Valve Implantation in Patients With Low Versus Intermediate to High Surgical Risk.

Referral of low surgical risk (LSR) patients for transcatheter aortic valve implantation (TAVI) becomes common in multiple tertiary centers, and clinical trial data for this population are not available to date. We performed a retrospective analysis on an Israeli multicenter registry. LSR and intermediate-high surgical risk (I-HSR) were defined by a Society of Thoracic Surgery score of <4% and ≥4%, respectively. The cohort included 2336 patients (LSR n = 1198, I-HLR n = 1138). As compared with LSR, patients with I-HSR were older and had significantly higher rates of baseline comorbidities. Although devices success rates (94% vs 96%), paravalvular leak (3.5% vs 5.2%), and permanent pacemaker implantation (17.2 vs 18%) were comparable (p >0.05 for all comparisons), the safety outcome at 1 month (12.7% vs 9.8%), procedural mortality (1.9% vs 0.6%), and mortality at 3 years (30.1% vs 16.1%) were higher in patients with I-HSR (p <0.05 for all comparisons). In a subanalysis of patients with very LSR, comparable rates of device success and safety outcomes were observed, whereas mortality at 1 to 3 years was lower. In conclusion, although procedural outcomes were comparable between LSR and I-HSR TAVI patients, the rates of short- and long-term mortality, as well as the safety outcome, were lower in LSR patients.

Coronary Sinus Reducer implantation improves symptoms, ischaemia and physical capacity in patients with refractory angina unsuitable for myocardial revascularisation: a single-centre experience.

AIMS: The aim of this study was to evaluate the clinical efficacy of Coronary Sinus Reducer implantation in alleviating angina symptoms and improving objective ischaemia parameters and indices of physical capacity. METHODS AND RESULTS: Patients with refractory angina (Canadian Cardiovascular Society [CCS] class 3-4) were treated with the Reducer. Baseline and follow-up evaluation consisted of clinical assessment including completion of the Seattle Angina Questionnaire (SAQ) and CCS class evaluation, and objective assessment by treadmill exercise test, dobutamine echocardiography and six-minute walk test (6MWT). Overall, 48 patients (40 male) were enrolled. No periprocedural or long-term adverse events were recorded. CCS class diminished from a mean of 3.4±0.5 at baseline to 2.0±1 (p<0.001), and all domains of the SAQ improved significantly following Reducer implantation. Mean exercise duration increased from 03:43±01:30 to 04:36±02:18 min:sec (p=0.025) and 6MWT distance increased from 299.9±97.9 m to 352.9±75.3 m (p=0.002). Ejection fraction (EF%) at stress increased from 51.0±10 to 56.5±10 (p=0.004), and wall motion score index improved from 1.58±0.4 to 1.37±0.3 (p=0.004). CONCLUSIONS: Reducer implantation for the treatment of refractory angina is a simple and safe procedure which significantly alleviates symptoms of angina and improves objective ischaemia parameters and indices of physical function.

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.

Steroid therapy and conduction disturbances after transcatheter aortic valve implantation.

BACKGROUND: Direct mechanical compression of the frame struts on the adjacent bundle branch with local inflammatory reaction might cause conduction system disturbances and need for pacemaker implantation following transcatheter aortic valve implantation (TAVI). We assessed the impact of preprocedural anti-inflammatory steroid therapy on the occurrence of conduction disturbances following TAVI. METHODS AND RESULTS: From a cohort of 324 patients who underwent transfemoral TAVI, 39 (12%) were pretreated with steroids because of iodine allergy (n=29) or active obstructive pulmonary disease (n=10). We compared the rate of occurrence of new conduction disturbances and pacemaker implantation between TAVI patients with (n=39) and without (n=285) steroid treatment, using Cox logistic regression estimates and proportional hazards models. The overall occurrence of new conduction defects and the need for new pacemaker implantation were similar among steroid and non-steroid-treated patients (38.4% vs 37.5% and 25.6% vs 25.3%, respectively). New conduction disturbances were more prevalent in patients treated with CoreValve prosthesis, low implantation, and smaller aortic annulus diameter (P<.001, P<.001, and P=.006, respectively). Thirty-day mortality and complication rates were similar between the groups. CONCLUSION: Although safe, steroid treatment prior to TAVI failed to reduce the incidence of new conduction defects and the need for pacemaker implantation.