Conduction disorders following transcatheter aortic valve replacement using acurate Neo2 transcatheter heart valve: A propensity matched analysis.

BACKGROUND: The ACURATE neo2 transcatheter aortic valve was developed to improve paravalvular leak (PVL) rates while maintaining low rates of conduction disturbances and permanent pacemaker implantation (PPMI) seen with its predecessor. We aimed to compare conduction disturbances rates of transcatheter aortic valve replacement (TAVR) using ACURATE Neo2 with other commonly used valves. METHODS: A retrospective analysis of the Israeli TAVR registry between the years 2014-2023 was performed to compare conduction disturbances and PVL rates, and procedural outcomes, among patients treated with ACURATE neo2, Edwards Sapien 3 (S3), and Evolut PRO valves. Propensity score matching was performed to compare groups with similar characteristics. RESULTS: Following exclusion of patients with non-femoral access, unknown valve type, older-generation valves, and less commonly used valves or (n = 4387), our analysis included 3208 patients undergoing TAVR using ACURATE neo2, Edwards S3, and Evolut PRO valves. Propensity matched groups comprised 169 patients each. Rates of any conduction disturbances [left bundle branch block (LBBB), atrioventricular block, or PPMI] were lower in the ACURATE neo2 group compared to both other valves [15.8 %, S3-37.5 % (p < 0.001), Evolut PRO-27.5 % (p = 0.02)] as were LBBB rates [9.0 %, S3-31.3 % (p < 0.001); Evolut PRO-20.1 % (p = 0.01). Atrioventricular block and PPMI rates were lower without statistical significance, as were rates of above-moderate PVL. CONCLUSIONS: In this analysis, TAVR using ACURATE neo2 was associated with a lower composite rate of conduction disturbances in comparison to the Evolut PRO and Edwards S3 valves, mainly due to lower left bundle branch block rates, with non-significantly lower rates of PPMI and PVL.

Evaluation of coronary disease among patients undergoing transcatheter aortic valve implantation: propensity score matching analysis.

BACKGROUND: Chronic coronary syndrome (CCS) is common among elderly patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). Current guidelines recommend performance of percutaneous coronary intervention (PCI) of any > 70% proximal coronary lesions prior to TAVI. AIMS: To evaluate the outcomes of two diagnostic approaches for CCS clearance pre-TAVI and to determine the reduction in the need of invasive angiography (IA). METHODS: We investigated 2219 patients undergoing TAVI for severe aortic stenosis at two large centers with different pre-procedural strategies for CCS assessment: pre-TAVI computed tomography angiography (CTA) with selective invasive angiography according to CTA results or mandatory IA. We preformed propensity score matching analysis using a 1:1 ratio. The final study cohort included 870 matched patients. Peri-procedural complications were documented according to the VARC-2 criteria. Mortality rates were prospectively documented. RESULTS: Mean age of the study population was 82 ± 7, of whom 55% were female. Patients in the IA group had significantly higher rates of pre-TAVI PCI compared to the CTA group (39% vs. 22%, p < 0.001). Following TAVI, peri-procedural myocardial infarction (MI) rates were similar between the two groups (0.3% vs. 0.7%, p value = 0.41), but spontaneous MI were significantly lower among the IA group (0% vs. 1.3%, p value = 0.03). Kaplan-Meier's survival analysis found that the cumulative probability of 1-year morality was similar between the two groups (p value log rank = 0.65). Cox regression analysis did not find association between CCS clearance strategy and outcome. CONCLUSIONS: In elderly patients, CTA-driven approach for CCS evaluation pre-TAVI is a valid strategy with similar outcome as compared to invasive approach. CTA strategy significantly reduces invasive procedures rates without compromising patient's outcome.

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.

Temporal Trends of Transcatheter Aortic Valve Implantation over 12 Years: A High-Volume Single-Center Experience.

Transcatheter aortic valve replacement (TAVR) has become the mainstay of treatment for patients with severe AS. Since the TAVR population and patients' outcomes have dramatically changed over the last decade, updated data regarding contemporary practice and trends are pertinent to clinical use. We performed a retrospective observational analysis of consecutive patient who underwent TAVR for symptomatic severe AS between the years 2009 and 2021 in a single high-volume center. Patients were divided into four equal time groups based on the procedure date (2009−2012, 2013−2015, 2016−2018 and 2019−2021). A total of 1988 patients were included in this study and divided into four groups, with 321, 482, 565 and 620 patients in groups 1−4, respectively. Significant trends were seen in baseline characteristics of a few parameters, including lower age, lower procedural risk and reduced rates of comorbidity (p for trend < 0.0001 for all factors mentioned above). A shift was seen in the procedural technique with lower balloon pre-dilatation and higher device success rates (p for trend < 0.0001). The post-procedural period changed over the years with fewer pacemaker placements (p < 0.0001) and reduced rates of AKI and post-procedural bleed (p value 0.02 and <0.0001, respectively). Furthermore, overall hospital stay was shortened from 7 ± 7.1 days to 2.3 ± 1.7 (p < 0.0001). Finally, patient follow up revealed reduced mortality rates at 30 days (p < 0.0001) and 1 year (p = 0.013). Multivariate regression revealed that a late implantation date was an independent protector from mortality (HR 0.84, p = 0.002). In conclusion, our study demonstrated that TAVR has become a safer practice over the years with reduced rates of morbidity and mortality.

Clinical Predictors for Procedural Stroke and Implications for Embolic Protection Devices during TAVR: Results from the Multicenter Transcatheter Aortic Valve Replacement In-Hospital Stroke (TASK) Study.

Background: Data to support the routine use of embolic protection devices for stroke prevention during transcatheter aortic valve replacement (TAVR) are controversial. Identifying patients at high risk for peri-procedural cerebrovascular events may facilitate effective patient selection for embolic protection devices during TAVR. Aim: To generate a risk score model for stratifying TAVR patients according to peri-procedural cerebrovascular events risk. Methods and results: A total of 8779 TAVR patients from 12 centers worldwide were included. Peri-procedural cerebrovascular events were defined as an ischemic stroke or a transient ischemic attack occurring ≤24 h from TAVR. The peri-procedural cerebrovascular events rate was 1.4% (n = 127), which was independently associated with 1-year mortality (hazards ratio (HR) 1.78, 95% confidence interval (CI) 1.06−2.98, p < 0.028). The TASK risk score parameters were history of stroke, use of a non-balloon expandable valve, chronic kidney disease, and peripheral vascular disease, and each parameter was assigned one point. Each one-point increment was associated with a significant increase in peri-procedural cerebrovascular events risk (OR 1.96, 95% CI 1.56−2.45, p < 0.001). The TASK score was dichotomized into very-low, low, intermediate, and high (0, 1, 2, 3−4 points, respectively). The high-risk TASK score group (OR 5.4, 95% CI 2.06−14.16, p = 0.001) was associated with a significantly higher risk of peri-procedural cerebrovascular events compared with the low TASK score group. Conclusions: The proposed novel TASK risk score may assist in the pre-procedural risk stratification of TAVR patients for peri-procedural cerebrovascular events.

Local Anesthesia versus Conscious Sedation among Patients Undergoing Transcatheter Aortic Valve Implantation-A Propensity Score Analysis.

BACKGROUND: Conscious sedation (CS) has been used successfully to treat patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) and as such is considered the standard anesthesia method. The local anesthesia (LA) only approach may be feasible and safe thanks to improvements in operators' experience. OBJECTIVE: To evaluate differences between LA only versus CS approaches on short- and long-term outcomes among patients undergoing TAVI. METHODS: We performed a propensity score analysis on 1096 patients undergoing TAVI for severe AS. Two hundred and seventy-four patients in the LA group were matched in a ratio of 1:3 with 822 patients in the CS group. The primary outcome was a 1-year mortality rate. Secondary outcomes included procedural and peri-procedural complication rates and in-hospital mortality. RESULTS: Patients in the CS group had significantly higher rates of grade 2-3 acute kidney injury and were more likely to have had new left bundle branch block and high-degree atrioventricular block. Patients who underwent TAVI under CS had significantly higher in-hospital and 1-year mortality rates compared to LA (1.6% vs. 0.0% p-value = 0.036 and 8.5% vs. 3.3% p-value = 0.004, respectively). Kaplan-Meier's survival analysis showed that the cumulative probability of 1-year mortality was significantly higher among subjects undergoing CS compared to patients LA (p-value log-rank = 0.024). Regression analysis indicated that patients undergoing CS were twice more likely to die of at 1-year when compared to patients under LA (HR 2.18, 95%CI 1.09-4.36, p-value = 0.028). CONCLUSIONS: As compared to CS, the LA-only approach is associated with lower rates of peri-procedural complications and 1-year mortality rates.

Generational Differences in Outcomes of Self-Expanding Valves for Transcatheter Aortic Valve Replacement.

BACKGROUND: The Medtronic Evolut Pro valve (EPV) is a new-generation self-expanding valve (SEV), particularly designed to reduce paravalvular leak (PVL) rates in transcatheter aortic valve replacement (TAVR). We aimed to compare the safety and efficacy of EPV with older-generation SEVs, in particular, postprocedural PVL and permanent pacemaker (PPM) implantation rates. METHODS: We performed a retrospective, multicenter, propensity-matched analysis of the Israeli TAVR registry between September 2008 and June 2019. Two independent propensity score-matched comparisons were performed comparing EPV with the first-generation CoreValve (CV), and comparing EPV with the second-generation Evolut R valve (ERV). RESULTS: The registry included 2591 patients who were propensity-matched into 3 cohorts: EPV (n = 222), CV (n = 212), and ERV (n = 213). Moderate and above PVL rates were lower for EPV (angiographic PVL [aPVL], 0.6%; echocardiographic PVL [ePVL], 3.0%) as compared with CV (aPVL, 7.8% [P<.001] and ePVL, 11.6% [P<.01]), but not as compared with ERV (aPVL, 6.4% [P<.01] and ePVL, 4.4% [P=.57]). Lower rates of PPM were noted for EPV (16.3%) as compared with both CV (33.5%; P<.001) and ERV (24.4%; hazard ratio, 0.61; 95% confidence interval, 0.37-0.995; P=.046). Other safety and efficacy outcome rates were excellent, with significant improvements as compared with older-generation SEVs. CONCLUSIONS: The EPV demonstrates excellent procedural safety and efficacy outcomes. Moderate and above PVL rates were significantly reduced in comparison with CV; however, not significantly reduced as compared with ERV. The need for PPM implantation was lower as compared with both older-generation valves.

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 Valve Size on Paravalvular Leak and Valve Hemodynamics in Patients With Borderline Size Aortic Valve Annulus.

Background: Transcatheter heart valve (THV) selection for transcatheter aortic valve implantation (TAVI) is crucial to achieve procedural success. Borderline aortic annulus size (BAAS), which allows a choice between two consecutive valve sizes, is a common challenge during device selection. In the present study, we evaluated TAVI outcomes in patients with BAAS according to THV size selection. Methods: We performed a retrospective study including patients with severe aortic stenosis (AS) and BAAS, measured by multi-detector computed tomography (MDCT), undergoing TAVI with self-expandable (SE) or balloon-expandable (BE) THV from the Israeli multi-center TAVI registry. The aim was to evaluate outcomes of TAVI, mainly paravalvular leak (PVL) and valve hemodynamics, in patients with BAAS (based on MDCT) according to THV sizing selection in between 2 valve sizes. In addition, to investigate the benefit of shifting between different THV types (BE and SE) to avoid valve size selection in BAAS. Results: Out of 2,352 patients with MDCT measurements, 598 patients with BAAS as defined for at least one THV type were included in the study. In BAAS patients treated with SE-THV, larger THV selection was associated with lower rate of PVL, compared to smaller THV (45.3 vs. 64.5%; pv = 0.0038). Regarding BE-THV, larger valve selection was associated with lower post-procedural transvalvular gradients compared to smaller THV (mean gradient: 9.9 ± 3.7 vs. 12.5 ± 7.2 mmHg; p = 0.019). Of note, rates of mortality, left bundle branch block, permanent pacemaker implantation, stroke, annular rupture, and/or coronary occlusion did not differ between groups. Conclusion: BAAS is common among patients undergoing TAVI. Selection of a larger THV in these patients is associated with lower rates of PVL and optimized THV hemodynamics with no effect on procedural complications. Additionally, shift from borderline THV to non-borderline THV modified both THV hemodynamics and post-dilatation rates.

Comparison of permanent pacemaker implantation rate after first and second generation of transcatheter aortic valve implantation-A retrospective cohort study.

OBJECTIVES: This study aimed to compare permanent pacemaker implantation (PPMI) rates among patients undergoing Trans-catheter Aortic Valve Implantation (TAVI) with first generation (G1) versus second generation (G2) valves and the impact of PPMI on long-term mortality. BACKGROUND: PPMI is a known adverse event after TAVI. Recently, two novel iterations of valve designs of both the balloon expandable valves (BEV) and self-expanding valves (SEV) were introduced as a second generation valves. METHODS: All patients included in the Israeli multicenter TAVI registry were grouped according to valve type (BEV vs. SEV) and generation (G1 vs. G2). A comparison was made for clinical and outcome indices of patients undergoing TAVI with G1 and G2 in each of the valve systems. RESULTS: A total of 1377 patients were included. The incidence of PPMI did not differ between G1-BEV versus G2-BEV (15.3% vs. 17.4%; p = 0.598) nor between G1-SEV versus G2-SEV (23.4% vs. 20.3%; p = 0.302). Depth of implantation and complete right bundle branch block were independently associated with PPMI post-TAVI in both valve systems. PPMI was not associated with an increased risk for 2-year mortality. CONCLUSIONS: The incidence of PPMI remains a relevant adverse event post-TAVI even when the newer generation valves are used. Since the predictors for PPMI are well established, a standardized approach for the management of conduction disorders is much needed.

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.

Prognostic implication of right ventricular dysfunction and tricuspid regurgitation following transcatheter aortic valve replacement.

OBJECTIVES: Right ventricular (RV) dysfunction and tricuspid regurgitation (TR) are associated with adverse outcomes in severe aortic stenosis (AS) patients. Our aim was to evaluate the association between ≥moderate TR and RV dysfunction on long-term mortality following transcatheter aortic valve replacement (TAVR). METHODS: A retrospective analysis of the Israeli multicenter TAVR registry among 4,344 consecutive patients, with all-cause mortality as the main outcome measure. RESULTS: Echocardiographic assessment of TR grade and RV dysfunction was available for 3,733 and 1,850 patients, of whom ≥moderate TR and RV dysfunction was noted for 478(13%) and 78(4%), respectively. The mean follow-up time was 2.9 ± 2.3 years. In univariate models, ≥Moderate TR and ≥moderate RV dysfunction were associated with increased long-term mortality (HR 1.45, 95% CI 1.24-1.69, p < .001 and HR 1.73, 95% CI 1.21-2.47, p = 0.003, respectively). These finding did not remained significant after adjusting to echocardiographic parameters. A subset of patients with no improvement in RV function had the highest long-term mortality risk (HR 3.3, 95% CI 1.95-5.7, p < .001). CONCLUSION: When adjusted to multiple echocardiographic characteristics baseline ≥Moderate TR and ≥moderate RV dysfunction were not associated with long-term mortality following TAVR. Persistent RV dysfunction following TAVR was associated with the highest risk for mortality.

Effect of pacemaker implantation after transcatheter aortic valve replacement on long- and mid-term mortality.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become quite common. Atrioventricular conduction defects remain a frequent complication resulting with permanent pacemaker (PPM) implantation. Past studies showed conflicting results regarding PPM effect on mortality. OBJECTIVE: The purpose of this study was to assess the influence of PPM implantation on mid- and long-term mortality in a large cohort of patients who underwent TAVR. METHODS: Patients undergoing TAVR between 2009 and 2019 were categorized into groups: no PPM implanted (no-PPM), PPM implanted before the procedure (pre-PPM), and PPM implanted postprocedure (post-PPM). All-cause mortality up to 6 years was compared. Subanalyses were performed according to pacing burden. Proportion of patients who had decreased left ventricular ejection fraction within 1 year of the procedure after TAVR was also recorded. RESULTS: A total of 1489 patients were followed. Unadjusted mortality was similar for patients regardless of PPM status within 12 months (P > .187), yet within 72 months, mortality was similar for the post-PPM (P = .257) and higher for pre-PPM (hazard ratio 1.53; P = .002) groups. Analysis adjusted by clinical characteristics did not show any independent long- or mid-term survival effects of PPM (P > .563). Analysis according to pacing burden showed no significant mortality difference (P > .8). Analysis of post-PPM patients with "high" or "near constant" (>40%) pacing burden vs no-PPM patients showed similar mortality for both mid- and long-term mortality (P = .055 and P = .513). Left ventricular ejection fraction decrease within 1 year was more common in both PPM groups, with a higher proportion with higher pacing burden (P < .001). CONCLUSION: This cohort of consecutive patients undergoing TAVR showed that postprocedure PPM was not associated with increased long-term mortality. This conclusion was not altered by ventricular pacing burden.

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.

Re-Appraisal of Echocardiographic Assessment in Patients with Pulmonary Embolism: Prospective Blinded Long-Term Follow-Up.

BACKGROUND: Acute pulmonary embolism (PE) is considered to be one of the most common cardiovascular diseases with considerable mortality. Conflicting data imply possible role for echocardiography in assessing this disease. OBJECTIVES: To determine which of the echo parameters best predicts short-term and long-term mortality in patients with PE. METHODS: We prospectively enrolled 235 patients who underwent computed tomography of pulmonary arteries (CTPA) and transthoracic Echocardiography (TTE) within < 24 hours. TTE included a prospectively designed detailed evaluation of the right heart including right ventricular (RV) myocardial performance index (RIMP), RV end diastolic and end systolic area, RV fractional area change, acceleration time (AT) of pulmonary flow and visual estimation. Interpretation and performance of TTE were blinded to the CTPA results. RESULTS: Although multiple TTE parameters were associated with PE, all had low discriminative capacity (AUC < 0.7). Parameters associated with 30-day mortality in univariate analysis were acceleration time (AT) < 81 msec (P = 0.04), stroke volume < 44 cc (P = 0.005), and RIMP > 0.42 (P = 0.05). The only RV independent echo parameter associated with poor long-term prognosis (adjusted for significant clinical, and routine echo associates of mortality) was RIMP (hazard ratio 3.0, P = 0.04). The only independent RV echo parameters associated with mortality in PE patients were RIMP (P = 0.05) and AT (P = 0.05). Addition of RIMP to nested models eliminated the significance of all other parameters assessing RV function. CONCLUSIONS: Doppler-based parameters like pulmonary flow AT, RIMP, and stroke volume, have additive value in addition to visual RV estimation to assess prognosis in patients with PE.

Coronary Access After TAVR-in-TAVR as Evaluated by Multidetector Computed Tomography.

OBJECTIVES: The aim of this study was to assess coronary accessibility after transcatheter aortic valve replacement (TAVR)-in-TAVR using multidetector computed tomography. BACKGROUND: Expanding TAVR to patients with longer life expectancy may involve more frequent bioprosthetic valve failure and need for redo TAVR. Coronary access after TAVR-in-TAVR may be challenging, particularly as the leaflets from the initial transcatheter heart valve (THV) will form a neo-skirt following TAVR-in-TAVR. METHODS: In 45 patients treated with different combinations of CoreValve and Evolut (CV/EV) THVs with supra-annular leaflet position and SAPIEN THVs with intra-annular leaflet position, post-TAVR-in-TAVR multidetector computed tomographic scans were analyzed to examine coronary accessibility. RESULTS: After TAVR-in-TAVR, the coronary arteries originated below the top of the neo-skirt in 90% of CV/EV-first cases compared with 67% of SAPIEN-first cases (p = 0.009). For these coronary arteries originating below the top of the neo-skirt, the distance between the THV and the aortic wall was <3 mm in 56% and 25% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.035). Coronary access may be further complicated by THV-THV stent frame strut misalignment in 53% of CV/EV-in-CV/EV cases. The risk for technically impossible coronary access was 27% and 10% in CV/EV-first and SAPIEN-first cases, respectively (p = 0.121). Absence of THV interference with coronary accessibility can be expected in 8% and 33% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.005). CONCLUSIONS: Coronary access after TAVR-in-TAVR may be challenging in a significant proportion of patients. THVs with intra-annular leaflet position or low commissural height and large open cells may be preferable in terms of coronary access after TAVR-in-TAVR.

Impact of right ventricular volumes on the outcomes of TAVR: a volumetric analysis of preprocedural computed tomography.

AIMS: The aim of this study was to assess the prognostic implications of increased right ventricle volume index (RVVI) using cardiac-gated computed tomography angiography (CCTA) data among patients undergoing transcatheter valve replacement (TAVR). METHODS AND RESULTS: CCTA of 323 patients who underwent TAVR at Stanford University Medical Center (CA, USA) and Tel Aviv Medical Center (Israel) between 2013 and 2016 was analysed by an automatic four-chamber volumetric software and grouped into quartiles according to RVVI. Higher one-year mortality rates were noted for the upper quartiles - 5%, 4.9%, 8.6%, and 16% (p=0.039), in Q1 <59 ml/m2, Q2 59-69 ml/m2, Q3 69-86 ml/m2, and Q4 >86 ml/m2, respectively. However, the differences were not significant after propensity score adjustments. Sub-analyses of Q1 demonstrated an escalating risk for one-year mortality in concordance to RVVI: HR 2.28, HR 2.76, and HR 4.7, for the upper 25th, 15th, and 5th percentiles, respectively (p<0.05 for all comparisons). After propensity score adjustments for clinical and echocardiographic characteristics, only the upper 5th percentiles (RVVI >120 ml/m2) retained statistical significance (HR 2.82, 95% CI: 1.02-7.78, p=0.045). Notably, 68.7% of patients from this group were considered low-intermediate risk for surgery. CONCLUSIONS: Cardiac volumetric data by CCTA performed for procedural planning may help to predict outcome in patients undergoing TAVR.

Automated external defibrillator use and outcomes after out-of-hospital cardiac arrest: an Israeli cohort study.

BACKGROUND: Out-of-hospital cardiac arrests (OHCA) are a serious healthcare situation with low survival rates. Application of an automated external defibrillator (AED) by bystanders shortens time to defibrillation and increases survival. In Israel, a regulation ensuring the presence of AED in public places was issued and implemented since 2014. We investigated whether this regulation had an impact on the outcomes of OHCA patients. METHODS: We performed a retrospective, single-center observational study. Included in the cohort were patients who were admitted to the department of intensive care cardiac unit with OHCA. Patients were stratified into two groups according to the year the regulation was introduced: group 1 (2009-2013) and group 2 (2014-2018). RESULTS: A total of 77 patients were included in group 1 and 61 in group 2. The utilization of AED was significantly higher in group 2 compared to group 1 (42% vs. 27%; P = 0.04). Compared to group 1 patients, group 2 had lower 48 h (0% vs. 8%; P = 0.02) and 30-day mortality (28% vs. 42%; P = 0.02). Cognitive damage following recovery was less frequent in group 2 (55% vs. 81%; P = 0.01). CONCLUSION: Deployment of AEDs in public places by mandatory regulations increased utilization for OHCA and may improve outcomes.

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.

Effectiveness and Safety of Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis and Variable Ejection Fractions (<40%, 40%-49%, and >50%).

We evaluated the safety and efficacy of transcatheter aortic valve implantation (TAVI) in aortic stenosis patients with mid-range ejection fraction (ASmrEF) and compared it to aortic stenosis patients with reduced ejection fraction (ASrEF) and preserved ejection fraction (ASpEF). TAVI cases were stratified by baseline ejection fraction (ASrEF, ASmrEF, ASpEF) and compared for characteristics, procedural outcomes, and change in echocardiographic parameters at 1 year and mortality over a 5-year follow-up. The final study population included 708 patients who underwent TAVI. ASmrEF patients presented with improved EF at 1-year after procedure (49.0 ± 9.8 at 1 year vs 43.0 ± 2.5 at baseline, p <0.001) and showed improvements in left ventricular (LV) diameters (LV end-diastolic diameter: 50.4 ± 6.0 at 1 year vs 53.0 ± 5.5 at baseline and LV end-systolic diameter 34.7 ± 7.8 at 1 year vs 39.5 ± 5.9 at baseline, p <0.001 for both). LVEF improved for patients with ASrEF but not in ASpEF patients. LV diameters did not improve for patients in either group. Procedural safety and success rates were similar between all heart failure groups. Survival rates over a 5-year follow-up post-TAVI were not different between patients with ASmrEF, ASrEF, and ASpEF (ASrEF 78.4%, ASmrEF 81.9%, ASpEF 78.3%, p = 0.327). TAVI for patients with ASmrEF is safe and effective and results in marked improvement of LV function and structure.