Ticagrelor versus Prasugrel in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Analysis from the Acute Coronary Syndrome Israeli Survey.

INTRODUCTION: We aimed to compare the outcomes of acute coronary syndrome (ACS) patients undergoing in-hospital percutaneous coronary intervention treated with prasugrel versus ticagrelor. METHODS: Among 7,233 patients enrolled to the Acute Coronary Syndrome Israeli Survey (ACSIS) between 2010 and 2018, we identified 1,126 eligible patients treated with prasugrel and 817 with ticagrelor. Comparison between the groups was performed separately in ST-elevation myocardial infarction (STEMI) patients, propensity score matched (PSM) STEMI patients, and non-ST-elevation ACS (NSTE-ACS) patients. RESULTS: In-hospital complication rates, including rates of stent thrombosis, were not significantly different between groups. In PSM STEMI patients, 30-day re-hospitalization rate (p < 0.05), 30-day MACE (the composite of death, MI, stroke, and urgent revascularization, p = 0.006), and 1-year mortality rates (p = 0.08) were higher in the ticagrelor group compared to the prasugrel group; in NSTE-ACS patients, outcomes were not associated with drug choice. In Cox regression analysis applied on the entire cohort, prasugrel was associated with lower 1-year mortality in STEMI patients but not in NSTE-ACS patients (p for interaction 0.03). CONCLUSIONS: Compared to ticagrelor, prasugrel was associated with superior clinical outcomes in STEMI patients, but not in NSTE-ACS patients.

Preoperative evaluation of pulmonary hypertension in lung transplant candidates: echocardiography versus right heart catheterization.

BACKGROUND: Right heart catheterization (RHC) and echocardiography are both routinely used for pulmonary artery systolic pressure (PASP) assessment in lung transplantation (LT) candidates, although this is not mandated by current guidelines. We aimed to explore the performance of echocardiographic PASP as an indicator of pulmonary hypertension in LT candidates, in order to assess the necessity of RHC. METHODS: From a retrospective registry of 393 LT candidates undergoing RHC and echocardiography during 2015-2019, patients were assessed for the presence of pulmonary hypertension (PH), defined as mean pulmonary artery pressure (mPAP) above 20 mmHg, according to two methods-echocardiography and RHC. The primary outcome was the correlation between the PASP estimated by echocardiography to that measured by RHC. Secondary outcomes were the prediction value of the echocardiographic evaluation and its accuracy. RESULTS: The mean value of PASP estimated by echocardiography was 49.5 ± 20.0 mmHg, compared to 42.5 ± 18.0 mmHg measured by RHC. The correlation between the two measurements was moderate (Pearson's correlation: r = 0.609, p < 0.01). Echocardiography PASP measurements were moderately discriminative to diagnose PH, with an area under the curve (AUC) of 0.72 (95% CI 0.66-0.77). Echocardiographic overestimation of PASP of more than 10 mmHg was found in 35.0% of the patients, and underestimation was found in 11.6% of the patients. CONCLUSION: In the pre-surgical evaluation of LT candidates, echocardiographic estimation of PASP had moderate correlation and limited accuracy compared to the PASP measured by RHC. We thus recommend performing routine RHC to all LT candidates, regardless of the echocardiographic estimation of PASP.

Coronary Artery Disease in patients with End-Stage Kidney Disease; Current perspective and gaps of knowledge.

Coronary artery disease (CAD) is very common in dialysis patients. One third have preexisting CAD and another one third have significant occult disease at the time of starting dialysis. Symptoms are often absent or are atypical, emphasizing the need for vigorous screening, specifically in patients awaiting transplant. The lesions tend to be heavily calcified, diffuse, and involve multiple vessels, consequently, percutaneous coronary interventions are more complicated to perform, and are less successful in achieving and maintaining short- and long-term patency. Dialysis patients have been excluded from the randomized controlled trials on which the current standards for managing CAD have been established. Due to differences in pathobiology and risks and benefits, it is uncertain that the results of these clinical trials extrapolate to patients with advanced chronic kidney disease (CKD). Here we review the data from observational studies and identify special considerations concerning the diagnosis and management of CAD in dialysis patients, including the use of noninvasive functional testing vs anatomical testing, the management of acute coronary syndromes and of stable coronary artery disease, the role for percutaneous revascularization vs coronary artery bypass grafting, and of platelet inhibitor therapy after coronary stenting. We review the preliminary results of the recently published ISCHEMIA-CKD trial, the only trial to date to involve large numbers of dialysis patients. This is the first of, hopefully, many trials in the pipeline that will examine therapies for CAD specifically in patients with advanced CKD, a growing population that is at particularly high risk for poor outcomes.

Periprocedural myocardial infarction in chronic total occlusion: The challenge of precise diagnosis and prognostication.

Myonecrosis following PCI is a frequent impediment that may impact cardiac prognosis. The frequency of periprocedural myocardial infarction (PMI) in CTO-PCI is dependent on MI definition (biomarker and threshold), lesions characteristics, and PCI course. This study identified predictors of PMI during CTO-PCI and it showed that PMI and peak CK-MB level were associated with worse clinical outcomes.

MitraClip-induced systolic anterior motion complicated by pericardial effusion: A case report.

Systolic anterior motion (SAM) of the anterior mitral leaflet is a well reported complication of surgical mitral valve repair (MVR). In the current report, we present a case of SAM with left ventricular outflow tract obstruction (LVOTO) which occurred after transcatheter mitral valve repair (TMVR) using the MitraClip device. LVOTO was caused by the combination of protrusion of the MitraClip device into the LVOT and underfilling of the left ventricle due to pericardial effusion and atrial fibrillation. Rapid clinical resolution and marked decline in LVOT pressure gradient occurred following surgical drainage and windowing of the pericardium. We conclude that SAM and LVOTO could occur after TMVR. Seeking and addressing reversible aggravators of LVOTO including pericardial effusion is essential and could potentially make the difference between a successful procedure and a failed one. © 2016 Wiley Periodicals, Inc.

Temporal trends in percutaneous coronary interventions thru the drug eluting stent era: Insights from 18,641 procedures performed over 12-year period.

BACKGROUND: The last decade, regarded as the DES era in PCI, has witnessed significant advances in the management of coronary disease. We aimed to assess temporal trends in the practice and outcome of percutaneous coronary intervention (PCI) during the drug eluting stent (DES) era. METHODS: We analyzed 18,641 consecutive PCI's performed between January 2004 and December 2016, distinguished by procedural date (Q1 : 2004-2006, n = 4,865; Q2 : 2007-2009, n = 4,977; Q3 : 2010-2012, n = 4,230; Q4 : 2013-2016, n = 4,569). RESULTS: At presentation, mean patients age was 65 (±11) years and 22.8% were females. Over time, there was a rise in the relative number of octogenarians (Q1 : 10.7% vs Q4 : 15.5%, P < 0.001) and an increase in the burden of most comorbidities (e.g., left ventricular dysfunction ≥ moderate and chronic kidney disease, P < 0.001 for both). Despite a 2-fold increase in the rate of complex interventions, and a 3-fold increase in the rate of unprotected left-main angioplasty (P < 0.001 for both), the radial approach was increasingly adopted (Q1 : 2% to Q4 : 63.5%, P < 0.001). DES implantation increased from 43% to 83% at the expense of bare metal stent (BMS) application, and accompanied by drug coated balloon sprout to 1.8%, P < 0.001. Kaplan-Meier survival curves revealed a time-based enhanced outcome, with a decreased rate of death, MI, target vessel revascularization and CABG over the years. CONCLUSIONS: In the last decade, PCI has evolved to offer better outcome to more elderly, sicker patient population, with more complex coronary disease interventions. The shift to second generation DES and to enhanced PCI techniques may explain part of this progress.

The Effect of Mineralocorticoid Receptor Antagonists on Recruitment and Function of Endothelial Progenitor Cells in Patients with Congestive Heart Failure.

BACKGROUND: Circulating endothelial progenitor cells have an important role in the process of vascular repair. Impaired recruitment and function of endothelial progenitor cells is related to the pathophysiology of congestive heart failure. Endothelial progenitor cells have been shown to express the mineralocorticoid receptor. OBJECTIVES: To investigate the effect of mineralocorticoid receptor antagonists on endothelial progenitor cells in patients with heart failure. METHODS: Twenty-four patients with compensated heart failure, who were not under mineralocorticoid receptor antagonist therapy, were recruited. Either eplerenone (n=8) or spironolactone (n=16) therapy was initiated. Circulating endothelial progenitor cell level, identified as the proportion of mononuclear cells expressing vascular endothelial growth factor receptor 2 (VEGFR-2), CD133, and CD34, was evaluated by flow cytometry at baseline and after 8 weeks. Following 7 days of culture, colonies were counted by microscopy and MTT assay was performed on randomly selected patients (n=12) to estimate viability. RESULTS: Both median CD34+/VEGFR2+ and median CD133+/VEGFR2+ increased significantly (P = 0.04 and 0.02, respectively). However, the number of colonies and viability of the cells after therapy (as assessed by the MTT assay) was not significantly different compared with the baseline. CONCLUSIONS: These preliminary results suggest that mineralocorticoid receptor blockade may enhance endothelial progenitor cells recruitment in patients with compensated heart failure.

Long Term Outcomes of MGuard Stent Deployment in Saphenous Vein Grafts and Native Coronary Arteries: A Single Center Experience.

BACKGROUND: The MGuard™ stent (InspireMD, Tel Aviv, Israel) is a bare metal mesh-covered stent, developed to prevent no-reflow phenomenon during percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) and acute myocardial infarction (MI), both associated with significant atherothrombotic lesions. OBJECTIVES: To report on local experience with patients treated with the MGuard stent until follow-up at 1 year. METHODS: We followed 163 consecutive patients who underwent MGuard stent deployment during the period 2009 to 2014 in a large tertiary cardiac center in central Israel. RESULTS: The MGuard stent was used in 67% of patients who underwent SVG-PCI while 33% were treated for native coronary artery disease, the majority during ST-elevation MI (STEMI). The mean age was 67 years and 83% were males. The clinical presentation was STEMI in 30% and non-STEMI/unstable angina in 60% of patients. Of the total number of patients, 47% had diabetes and 29% had chronic kidney disease. All patients had follow-up at 1 year. Mortality in the native group was 1.9% vs. 10% in the vein graft cohort. ST was 2% in both groups. The major adverse cardiac event (MACE) rates were 11% in the native artery and 29% in the vein graft group, mainly due to respective target lesion revascularization/target vessel revascularization rates of 6% and 7% in the native vessel group and 11% and 15% in the SVG group. CONCLUSIONS: In suitable patients undergoing SVG-PCI or native lesion intervention during acute MI, the MGuard stent is a viable treatment strategy. Its potential merits and limitations warrant further evaluation.

The Relationship between Cigarette Smoking and Renal Function: A Large Cohort Study.

BACKGROUND: Both cigarette smoking and chronic kidney disease (CKD) are linked to cardiovascular morbidity and development of atherosclerosis. However, the relationship between cigarette smoking and renal function is not clearly understood. OBJECTIVES: To investigate the relationship between cigarette smoking and renal function, and determine whether the intensity of cigarette smoking influences renal function. METHODS: We conducted a retrospective analysis of subjects attending the screening center at the Rabin Medical Center. Subjects were classified as smokers, non-smokers and past smokers. Renal function was evaluated by means of the CKD-EPI equation for estimating glomerular filtration rate (eGFR). Multivariate and gender-based analyses were performed. RESULTS: The study population comprised 24,081 participants, of whom 3958 (17%) were classified current smokers, and 20,123 non-smokers of whom 4523 were classified as past smokers. Current smokers presented a higher eGFR compared to the non-smoking group (100.8 vs. 98.7, P < 0.001) as well as higher rates of proteinuria (15.3% vs. 9.3%, P < 0.001). The difference in eGFR between smokers and non-smokers was more significant in males than in females. Past smokers had the lowest eGFR of all groups, this difference remained significant after age adjustments (P = 0.005). CONCLUSIONS: Cigarette smoking is associated with higher eGFR compared to non-smoking. This difference was more pronounced in males than females, implying a gender-based difference. The higher prevalence of proteinuria in smokers suggests a mechanism of hyperfiltration, which might result in future progressive renal damage.

The frequency and prognostic impact of fever following transcatheter aortic valve implantation.

OBJECTIVES: This study sought to explore the frequency and prognostic implications of infectious and noninfectious fever following transcatheter aortic valve implantation (TAVI). METHODS: We performed a retrospective cohort study including 194 consecutive patients who underwent TAVI at our institution. We identified and characterized all patients who developed fever within the first 72 h following the procedure. We determined the etiology of the fevers (infectious vs. noninfectious) and assessed their impact on in-hospital complications and 1-year mortality. RESULTS: Following TAVI, 65 (33.5%) patients had fever (mean age 83.7 ± 3.8 years, 70.2% female). An infectious etiology was evident in only 17 of the 65 patients (26.1%) with fever, mainly due to pneumonia (52.9%) and a urinary tract infection (41.2%). No significant difference was observed in baseline characteristics, the mean fever temperature/duration, or signs of inflammatory response between infectious and noninfectious fevers. The mean hospital duration was longer (7 ± 4.8 days vs. 4.7 ± 2.4 days, p = 0.01) among patients with an infectious fever; however, fever had no impact on the 1-year mortality rate (5.9 and 4.5%, respectively, p = 0.71). CONCLUSIONS: Our study demonstrates that, although fever was a common phenomenon after TAVI, it represented an infectious complication only in a minority of cases. Nevertheless, fever, infectious or not, had no impact on the 1-year mortality rate following TAVI.

Complex left appendage morphology is associated with Embolic Stroke of Undetermined Source.

INTRODUCTION: Variations in the left atrial appendage (LAA) morphology are associated with different embolic risk in patients with atrial fibrillation (AF). Data are scarce regarding the association between LAA morphology and Embolic stroke of undetermined source (ESUS). PATIENTS AND METHODS: Using cardiac computed tomography (CCT) scans, LAA morphology was categorized as either chicken wing (CW), cactus, windsock, or cauliflower. Furthermore, we examined the presence of large secondary lobes arising from the main lobe, considering their existence as indicative of a complex LAA morphology. LAA morphologies were compared between ESUS (n = 134) and AF patients (n = 120); and between ESUS patients with (n = 24) and without (n = 110) subsequent AF diagnosis during long-term follow-up. RESULTS: ESUS patients had a significantly higher prevalence of cauliflower morphology compared to AF group (52% vs 34%, respectively, p = 0.01); however, no significant difference was found between the groups when categorizing LAA morphology to either CW or non-CW. ESUS patients had significantly higher prevalence of large secondary lobes compared with AF patients (50% vs 29%, respectively, p = 0.001). When comparing ESUS patients with and without AF diagnosis during follow-up (20-48 months of follow-up, median 31 months), there were no significant differences in the prevalence of the "classical" morphologies, but large secondary lobes were significantly more prevalent among those without subsequent AF diagnosis. CONCLUSION: ESUS patients have a high prevalence of complex LAA morphology, which might be associated with an increased risk for thrombus formation even in the absence of AF.

Outcomes of Drug-Eluting Balloons for In-Stent Restenosis: Large Cohort Analysis and Single-Center Clinical Experience.

BACKGROUND: The use of drug-eluting balloons (DEBs) remains clinically relevant in the contemporary era of drug-eluting stent percutaneous coronary interventions (DES-PCI), especially in the setting of in-stent restenosis (ISR). Our goal was to assess the outcomes of ISR patients in a large prospective registry. METHODS: A total of 2329 consecutive patients with ISR-PCI (675 using DEB and 1654 with DES) were treated in our medical centre from 2010 to 2021. Clinical end points included mortality and major adverse cardiac events (MACE) at 1 year. Clinical outcomes were adjusted for multiple confounders. RESULTS: Mean ages (65.9 ± 11.0 vs 66.1 ± 10.5; P = 0.73) and percentages of female patients (16.6% vs 18.2%; P = 0.353) were similar between both ISR groups. Patients treated with DEB for ISR suffered more from diabetes, hypertension, and previous myocardial infarction (P < 0.01 for all) and presented more frequently with acute coronary syndrome (40.0% vs 34.4%; P = 0.01) compared with patients treated with DES for ISR. One-year MACE was significantly higher in the DEB ISR-PCI group (23.4% vs 19.6%; P = 0.002) compared to the DES ISR-PCI group, but no significant differences in mortality were observed at 1 year between the groups. After adjustment for multiple confounders, DEB ISR-PCI was not associated with increased MACE at 1 year (P = 0.55). CONCLUSIONS: In our large experience, patients treated with DEB for ISR-PCI have higher baseline risk and sustained increased MACE rates compared with DES ISR-PCI patients. After adjustment for confounding variables, clinical outcomes are similar between the groups at 1 year after PCI.

The real-world safety of sacubitril / valsartan among older adults (≥75): A pharmacovigilance study from the FDA data.

BACKGROUND: Heart failure is a major cause of morbidity and mortality among older adults. Sacubitril-Valsartan (Sac/Val) has been shown to improve patients' outcomes; however, its safety profile among older adults has not been adequately examined. We therefore aimed to examine its safety profile among this population. METHODS: We conducted a retrospective pharmacovigilance study utilizing the FDA's database of safety reports (FAERS). We employed disproportionality analysis comparing Sac/Val to angiotensin receptor blockers (ARBs). We aim to evaluate the reporting of pre-defined adverse events associated with Sac/Val (hypotension, acute kidney injury (AKI), hyperkalemia and angioedema) in two age groups: adults (< 75 years) and older adults (≥ 75). For each subgroup, we calculated reporting odds ratio (ROR) and compared them by calculating P for interaction. RESULTS: The FAERS database encompassed 18,432 unique reports of Sac/Val. Of them, 12,630 (68.5%) subjects were adults (< 75 years), and 5802 (31.5%) were older adults (≥ 75 years), with a median age (IQR) of 68 (59-77). When compared to ARBs, Sac/Val was associated with higher reporting of hypotension, lower reporting of acute kidney injury (AKI) and hyperkalemia, and similar reporting of angioedema. Notably, we did not observe a significant interaction between the age subgroups and the risk estimates (AKI: Pinteraction = 0.72, hyperkalemia: Pinteraction = 0.94, hypotension: Pinteraction = 0.31, and angioedema: Pinteraction = 0.61). CONCLUSIONS: In this postmarking study, none of the prespecified adverse events was reported more frequently in older adults. These findings provide reassurance for safety use of Sac/Val in older adults.

Is 90 the new 80? Temporal trends in nonagenarians undergoing percutaneous coronary interventions.

BACKGROUND: Coronary artery disease (CAD) is a leading cause of death in the elderly population. Data regarding percutaneous coronary interventions (PCIs) in nonagenarians are scarce, and differences in long term outcomes between generations remain unclear. We aimed to study the pattern and temporal trends of nonagenarians treated with PCI. MATERIALS AND METHODS: A total of 14,695 patients underwent PCI between 2009-2020. We identified 2,034 (13.8%) octogenarians (age 80-89), and 222 (1.5%) nonagenarians (age 90-99). Endpoints included mortality and major adverse cardiac events (MACE) at 1 year. MATERIALS AND METHODS: A total of 14,695 patients underwent PCI between 2009-2020. We identified 2,034 (13.8%) octogenarians (age 80-89), and 222 (1.5%) nonagenarians (age 90-99). Endpoints included mortality and major adverse cardiac events (MACE) at 1 year. RESULTS: The number of nonagenarians undergoing PCI has increased substantially during the study time period, from 89 patients in the earlier time period (2009-2014) to 133 patients in the later time period (2015-2020). At 1-year, nonagenarians had significantly higher rates of both death (24.3% vs. 14.9%, p<0.01), and MACE (30.6% vs. 22.0%, p<0.01), as compared to octogenarians. The cumulative survival rate was higher among octogenarians both in the early and late time period (p<0.01 and p=0.039, respectively). A significant reduction in nonagenarian MACE rates were observed during the study time period, resulting in a non-significant difference in MACE rates in the later time period between both groups. CONCLUSION: The number of nonagenarians who undergo PCI is on the rise. While their clinical outcomes are inferior as compared to younger age groups, improvement was noted in the late time period.

Outcomes and predictors of left ventricle recovery in patients with severe left ventricular dysfunction undergoing transcatheter aortic valve implantation.

BACKGROUND: Data on the likelihood of left ventricle (LV) recovery in patients with severe LV dysfunction and severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) and its prognostic value are limited. AIMS: We aimed to assess the likelihood of LV recovery following TAVI, examine its association with midterm mortality, and identify independent predictors of LV function. METHODS: In our multicentre registry of 17 TAVI centres in Western Europe and Israel, patients were stratified by baseline LV function (ejection fraction [EF] >/≤30%) and LV response: no LV recovery, LV recovery (EF increase ≥10%), and LV normalisation (EF ≥50% post-TAVI). RESULTS: Our analysis included 10,872 patients; baseline EF was ≤30% in 914 (8.4%) patients and >30% in 9,958 (91.6%) patients. The LV recovered in 544 (59.5%) patients, including 244 (26.7%) patients whose LV function normalised completely (EF >50%). Three-year mortality for patients without severe LV dysfunction at baseline was 29.4%. Compared to this, no LV recovery was associated with a significant increase in mortality (adjusted hazard ratio 1.32; p<0.001). Patients with similar LV function post-TAVI had similar rates of 3-year mortality, regardless of their baseline LV function. Three variables were associated with a higher likelihood of LV recovery following TAVI: no previous myocardial infarction (MI), estimated glomerular filtration rate >60 mL/min, and mean aortic valve gradient (mAVG) (expressed either as a continuous variable or as a binary variable using the standard low-flow, low-gradient aortic stenosis [AS] definition). CONCLUSIONS: LV recovery following TAVI and the extent of this recovery are major determinants of midterm mortality in patients with severe AS and severe LV dysfunction undergoing TAVI. Patients with no previous MI and those with an mAVG >40 mmHg show the best results following TAVI, which are at least equivalent to those for patients without severe LV dysfunction. (ClinicalTrials.gov: NCT04031274).

The Impact of Cerebral Embolic Protection Devices on Characteristics and Outcomes of Stroke Complicating TAVR.

BACKGROUND: Acute ischemic stroke remains a serious complication of transcatheter aortic valve replacement (TAVR). Cerebral embolic protection devices (CEPD) were developed to mitigate the risk of acute ischemic stroke complicating TAVR (AISCT). However, the existing body of evidence does not clearly support CEPD efficacy in AISCT prevention. OBJECTIVES: In a cohort of patients with AISCT, we aimed to compare the characteristics and outcomes of patients who have had unprotected TAVR (CEPD-) vs CEPD-protected TAVR (CEPD+). METHODS: Data were derived from an international multicenter registry focusing on AISCT. We included all patients who experienced ischemic stroke within 72 hours of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale (NIHSS). Primary outcomes were neurologic disability status according to the modified Rankin Score at 30 days, and 6-month all-cause death. Propensity score matched analysis was used to control for differences between groups. RESULTS: In 18,725 TAVR procedures, 416 AISCT (2.2%) within 72 hours were documented, of which 376 were in the CEPD- TAVR group and 40 in the CEPD+ TAVR group. Although the middle cerebral artery stroke rate was similar in both groups (29.7% CEPD- vs 33.3% CEPD+; P = 0.71), AISCT in the CEPD+ group was characterized by a lower rate of internal carotid artery occlusion (0% vs 4.7%) and higher rate of vertebrobasilar system strokes (15.4% vs 5.7%; P = 0.04). AISCT was severe (NIHSS ≥15) in 21.6% CEPD- and 23.3% CEPD+ AISCT (P = 0.20). Disabling stroke rates (modified Rankin Score >1 at 30 days) were 47.3% vs 42.5% (P = 0.62), and 6-month mortality was 31.3% vs 23.3% (P = 0.61), in the CEPD- and CEPD+ groups, respectively. In the propensity score matched cohort, disabling stroke rates were 56.5% vs 41.6% (P = 0.16), and 6-month mortality was 33% vs 19.5% (P = 0.35), in the CEPD- and CEPD+ groups, respectively. CONCLUSIONS: In a large cohort of patients with AISCT, the use of CEPD had little effect on stroke distribution, severity, and outcomes.

Embolization of percutaneous left atrial appendage closure devices: Timing, management and clinical outcomes.

BACKGROUND: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. OBJECTIVES: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. METHODS: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. RESULTS: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. CONCLUSIONS: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. CONDENSED ABSTRACT: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high.

Meta-analysis of short- and long-term clinical outcomes of the self-expanding Evolut R/pro valve versus the balloon-expandable Sapien 3 valve for transcatheter aortic valve implantation.

BACKGROUND: The Evolut R/Pro and the Sapien 3 are the most commonly valve systems used today for transcatheter aortic valve implantation (TAVI). However, there is a still uncertainty regarding the efficacy and safety comparison of these two valves. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies comparing the Evolut R/Pro versus the Sapien 3. The primary outcome was all-cause mortality (short and long-term). The secondary outcomes were stroke, bleeding, permanent pacemaker implantation (PPI), acute kidney injury (AKI), major vascular complication, device success, moderate- severe aortic regurgitation (AR), and pressure gradients. RESULTS: Twenty-one publications totaling 35,248 patients were included in the analysis. Evolut R/Pro was associated with higher risk of short-term all-cause mortality (OR = 1.31;95% CI 1.15-1.49, p < 0.001) and a trend of higher long-term mortality (OR = 1.07;95% CI 1.00-1.16, p = 0.06). The Evolut R/Pro was associated with higher risk of PPI and AR and lower risk for bleeding, major vascular complication, and pressure gradients. There was no significant difference between the groups regarding the risk of stroke, AKI and device success. CONCLUSIONS: The Evolut R/Pro valve system compared to the Sapien 3 is associated with higher risk of short-term mortality, significant AR and PPI while providing the advantage of lower risk of bleeding, major vascular complication, and lower residual transvalvular gradients.

Early and Mid-Term Outcomes of Transcatheter Aortic Valve Implantation versus Surgical Aortic Valve Replacement: Updated Systematic Review and Meta-Analysis.

(1) Background: The use of transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis is expanding significantly. We aimed to perform a meta-analysis comparing the safety and efficacy of TAVI versus surgical aortic valve replacement (SAVR) during the early and mid-term follow-up period. (2) Methods: We conducted a meta-analysis of randomized controlled trials (RCTs) comparing 1- to 2-year outcomes between TAVI and SAVR. The study protocol was preregistered in PROSPERO and the results were reported according to PRISMA guidelines. (3) Results: The pooled analysis included data from eight RCTs totaling 8780 patients. TAVI was associated with a lower risk of all-cause mortality or disabling stroke (OR 0.87, 95%CI 0.77-0.99), significant bleeding (OR 0.38, 95%CI 0.25-0.59), acute kidney injury (AKI; OR 0.53, 95%CI 0.40-0.69) and atrial fibrillation (OR 0.28, 95%CI 0.19-0.43). SAVR was associated with a lower risk of major vascular complication (MVC; OR 1.99, 95%CI 1.29-3.07) as well as permanent pacemaker implantation (PPI; OR 2.28, 95%CI 1.45-3.57). (3) Conclusions: TAVI compared with SAVR during early and mid-term follow-up was associated with a lower risk of all-cause mortality or disabling stroke, significant bleeding, AKI and atrial fibrillation; however, it was associated with a higher risk of MVC and PPI.