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Mesenteric ischemia is a rare but lethal complication of transcatheter aortic valve replacement (TAVR). We present a challenging case of an 80-year-old man who had abdominal pain few hours following TAVR. Repeated abdominal and pelvic imaging showed no vascular obstruction, but exploratory laparoscopy revealed a necrotic bowel. (Level of Difficulty: Intermediate.), Graphical abstract

We aimed to validate a new scoring system based on extent of cardiac damage for risk stratification in patients undergoing transcatheter aortic valve replacement (TAVR) in a real-world cohort and to examine the addition of baseline albumin in risk assessment.We investigated 2608 patients undergoing TAVR. Subjects were divided into five groups based on their echocardiography findings. Patients were further assessed by incorporating baseline albumin. Multivariable analysis demonstrated that each increase in stage was associated with significant increased risk of 1-year mortality (HR 1.37, 95%CI 1.23-1.54, p .001). Among patients at increased stage (3-4), incorporation of baseline of albumin identified the highest risk group, such that each 1 decrement in albumin levels was associated with more than triple increase in mortality among patients at stage 3 and 4 (HR 2.77, 95% CI 1.48-5.18, p-value = .001).Cardiac damage classification is validated in a real-world cohort of patients undergoing TAVR. Incorporation of low baseline albumin may further identify patients at the highest risk group.We evaluated 2608 patients undergoing transcatheter aortic valve replacement (TAVR) in order to validate a new scoring system dividing patients in to 5 stages (0-4) based on extent of cardiac damage. Patients were further assessed by incorporating baseline albumin. Multivariable analysis demonstrated that each increase in stage was associated with significant increased risk of 1-year mortality. Furthermore, among patients at increased stage (3-4), incorporation of baseline of albumin identified the highest risk group, such that each 1 decrement in albumin levels was associated with more than triple increase in mortality among patients at stage 3 and 4.

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.

Background Current guidelines recommend an early invasive strategy for patients with non-ST segment elevation myocardial infarction (NSTEMI). Purpose To evaluate whether early invasive strategy is associated with better outcome among patients with chronic kidney disease (CKD). Methods Retrospective cohort analysis of consecutive patients with NSTEMI between 2008 and 2021. Glomerular filtration rate (eGFR) was estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation. Invasively treated patients were dichotomized into early ( Results Final study population comprised 7,107 NSTEMI patients, of whom 3,172 (45%) had eGFR Conclusion Among invasively treated NSTEMI patients, the benefit of early invasive strategy is modified by CKD, and limited to those with eGFR ≥45 ml/min/1.73m2. Funding Acknowledgement Type of funding sources: None.

Background: A small proportion of patients in need of transcatheter aortic valve replacement (TAVR) are not suitable for the transfemoral approach due to peripheral artery disease. Alternative TAVR approaches are associated with short- and long-term hazards. A novel technique of caval-aortic (transcaval) access for TAVR has been utilized as an alternative access technique.Aim: To compare safety and efficacy of transcaval access as compared to other alternative access (axillary or apical) for TAVR.Methods: A single-center, retrospective analysis of consecutive patients undergoing alternative access for TAVR. Events were adjudicated according to VARC-2 criteria.Results: A total of 185 patients were included in the present analysis. Mean age was 81 years with a small majority for male gender (54%). Of the entire cohort, 20 patients (12%) underwent transcaval TAVR, and 165 patients (82%) underwent TAVR using alternative access. Overall, baseline characteristics were comparable between the two groups. General anesthesia was not utilized in transcaval patients; however, it was routinely used in nearly all alternative access patients. TAVR device success was comparable between the two groups (95%). Acute kidney injury occurred significantly less frequently among transcaval patients as compared to alternative access patients (5 vs. 12%, p = 0.05). Hospital stay was shorter for transcaval patients (6.3 days vs. 14.4; p < 0.001). No difference in early or 30-day mortality (10 vs. 7.9%, p = 0.74) was noted between groups.Conclusions: In patients who cannot undergo TAVR via the trans-femoral approach due to peripheral vascular disease, transcaval access is a safe approach as compared to other alternative access techniques, with lower risk of kidney injury and shorter hospital stay.

Chronic kidney disease (CKD) has a negative impact on outcomes after transcatheter aortic valve replacement (TAVR). Data on outcomes in renal transplant recipients (RTRs) undergoing TAVR are scarce. We compared the outcomes in RTRs undergoing TAVR with matched patients who have native kidneys and similar kidney function.This retrospective cohort study used data from 16 TAVR centres (13,941 patients). The study cohort included 216 patients (72 RTRs and 144 matched controls).The mean estimated glomerular filtration rate (eGFR) was 39.2 ± 23.6 vs 44.5 ± 23.6 mL/min for RTRs and control patients (P = 0.149), with a similar CKD stage distribution. After TAVR, the eGFR declined among RTRs but remained stable for up to 1 year in controls (P = 0.021). Long-term hemodialysis was required in 19 (26.4%) RTRs and 20 (13.8%) controls (hazard ratio [HR] = 2.09 95% confidence interval [CI], 1.03-3.86; P = 0.039) and was most often initiated during the periprocedural period (14 RTRs vs 16 controls; P = 0.039). After a median follow-up of 2.3 years, risk of death (29.2% vs 31.9%) and death/hemodialysis (40.3% vs 36.8%) was similar between the groups. The contrast volume/eGFR ratio was the strongest predictor of hemodialysis initiation (odds ratio [OR] = 1.64; 95% CI, 1.36-1.97 per 1 unit increase; P0.001), with a greater effect among RTRs than controls (P for interaction = 0.022).s: TAVR appears safe in RTRs with mortality rates similar to matched patients with native kidneys. However, RTRs carry an increased risk of progressive renal impairment and need for hemodialysis initiation after TAVR. Our data highlight the importance of minimizing contrast load during TAVR, particularly in RTRs.

While the combination of a small aortic valve area (AVA) and low mean gradient is frequently labeled 'low-flow low-gradient aortic stenosis (AS)', there are two potential causes for this finding: underestimation of mean gradient and underestimation of AVA.In order to investigate the prevalence and causes of discordant echocardiographic findings in symptomatic patients with AS and normal left ventricular (LV) function, we evaluated 72 symptomatic patients with AS and normal LV function by comparing Doppler, invasive, computed tomography (CT) LV outflow tract (LVOT) area, and calcium score (CaSc).Thirty-six patients had discordant echocardiographic findings (mean gradient40 mmHg, AV area ≤ 1 cm²). Of those, 19 had discordant invasive measurements (true discordant [TD]) and 17 concordant (false discordant [FD]): In 12 of the FD the mean gradient was30 mmHg; technical pitfalls were found in 10 patients (no reliable right parasternal Doppler in 6). LVOT area by echocardiography or CT could not differentiate between concordants and discordants nor between TD and FD (p = NS). CaSc was similar in concordants and FD (p = 0.3), and it was higher in true concordants than in TD (p = 0.005). CaSc positive predictive value for the correct diagnosis of severe AS was 95% for concordants and 93% for discordants.Discordant echocardiographic findings are commonly found in patients with symptomatic AS. Underestimation of the true mean gradient due to technical difficulties is an important cause of these discrepant findings. LVOT area by echocardiography or CT cannot differentiate between TD and FD. In the absence of a reliable and compete multi-window Doppler evaluation, patients should undergo CaSc assessment.

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

Transcatheter aortic valve-in-valve (VIV) is established treatment of degenerative surgical bioprostheses in patients at high operative risk and was approved by the US Food and Drug Administration in 2015. The AHA/ACC guidelines for the management of patients with valvular heart disease give it class IIa indication based on nonrandomized data including registries and case series only. When planning an aortic VIV procedure, therapy of small surgical valves should be approached with caution, as patient prosthesis mismatch (PPM) and significant residual gradients remain a major challenge. In addition, when the indication for the procedure is valve regurgitation, every effort should be taken to rule out aortic para-valvular leak, since VIV implantation is not expected to improve hemodynamics in this case. In addition to careful patient selection and procedural planning, the VIV procedure itself has particular operator-associated aspects that will be discussed in this chapter. Despite growing experience with this procedure, for selected patients, such as very-low-risk patients and patients with small diameter bioprosthesis, a heart team discussion should still consider the option of redo surgical aortic valve replacement.

Background Coronary artery disease (CAD) is common among elderly patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). Current guidelines recommend that percutaneous coronary intervention (PCI) of >70% proximal coronary lesions prior to TAVI. The aim of the current study was to evaluate two approaches to CAD diagnosis pre-TAVI. Methods We investigated 2,027 patients undergoing TAVI for severe aortic stenosis at two large centers with different pre-procedural CAD assessment: pre-TAVI computed tomography angiography (CTA) with selective invasive angiography according to CTA results (N=831) or mandatory invasive angiography (IA) (N=1,196). Peri-procedural complications were documented according to the VARC-2 criteria. Mortality rates were prospectively documented. Results Mean age of the study population was 86±4, of whom 55% were female. Patients in the IA group had significantly higher rates of pre-TAVI PCI compared to the CTA group (32% vs. 17%, p Conclusions In elderly patients, CTA driven approach for CAD 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. Funding Acknowledgement Type of funding source: None

Introduction Coronary clearance in patients undergoing TAVR is performed by invasive coronary angiography (ICA) or computed tomography angiography (CTA). We aimed to investigate whether CTA-derived low coronary calcium (CAC) score may rule out obstructive coronary artery disease (CAD) in these patients. Methods We included 232 consecutive patients with severe aortic stenosis (mean age 80±8; 50% female) who underwent both pre-TAVR CTA and ICA between 2012–2019. Obstructive CAD was defined as a >50% in left main or >70% in the 3 main epicardial vessels. Patients with prior coronary stents or bypass grafts were excluded. CAC score was calculated by Agatston method. Receiver operating characteristic (ROC) was applied to establish the CAC threshold for obstructive CAD, and adjustment for age, gender, diabetes and renal failure was applied. Results CAC scores range was 3.5–5200 (median = 1028). Eighty-eight patients (38%) had obstructive CAD. ROC curves showed high negative predictive value (NPV) for LAD - CAC score 280, NPV 95%; LCX - CAC score 320, NPV 93%; and RCA - CAC score 347, NPV 90% (figure). Binary logistic regression confirmed CAC score cutoffs per vessel as an independent predictor of obstructive CAD [LAD (OR 3.9, CI 1.1–14, p-0.033); CX (OR 5.7, CI 2.4–12, p Conclusion CAC score per-vessel can be useful to rule out obstructive CAD in patients with severe aortic stenosis undergoing TAVR. Using specific CAC cut offs can identify patients who may omit ICA CAC per vessel Funding Acknowledgement Type of funding source: None

Introduction and purpose Data on the survival of patients with moderate aortic stenosis (AS) is conflicting. The purpose of the current analysis was to assess survival of moderate AS patients. Methods SHARE is an historical retrospective cohort of all cardiovascular patients evaluated in an Israeli tertiary hospital between 2007 and 2019. The current analysis included all patients who underwent echocardiographic evaluation. Aortic stenosis severity was extracted for all patients from the echocardiographic reports. All-cause mortality and was available for all patients. Subjects with severe AS or aortic valve replacement were excluded from the analysis. Results Cohort included 97,561 subjects of whom 42,187 (43.2%) were outpatients. Final cohort included 93,889 patients with a mean age of 66±17 (58% men). There were 2,949 (3%) with moderate AS. During a median follow up of 52 [IQR 22–89] months 17,173 (18%) patients died. Kaplan-Meier survival analysis demonstrated worse cumulative probability of death of 51%±2% vs. 20%±0% at 5 years for patients with moderate AS vs. mild or no AS, respectively (p Log rank Conclusion Moderate AS is associated with worse survival. Our findings underscore the importance of careful clinical observation as well as the need for further studies. Figure 1 Funding Acknowledgement Type of funding source: None

Purpose To report long-term results of iliofemoral stent placement after transcatheter aortic valve replacement (TAVR). Materials and Methods TAVR access-related complications treated with iliofemoral stent placement were recorded in 56 patients (mean age, 81 years; range; 53–93 years; 48% male) of 648 patients who underwent TAVR at a single center. Fifty-six patients treated with stent placement (40 patients with stent grafts and 16 patients with bare metal stents) underwent clinical and ultrasonographic follow-up after a mean of 676 days (range, 60–1840 days). Results During follow-up, none of the 56 patients who had stent placement underwent a vascular reintervention of the affected limb, and none suffered from limb claudication. No decrease was observed in ankle-brachial index (ABI) values to an abnormal value, except in 1 patient (mean preprocedural and postprocedural ABI of 1.2 ± 0.14, range, 0.97–1.4 and 1.19 ± 0.24, range, 0.65–1.54, respectively). Arterial duplex assessment showed normal stent flow velocity (mean, 168.7 ± 63.2 cm/sec; range, 80–345 cm/sec) in all but 1 patient. Conclusion Iliofemoral stent implantation is a safe and efficacious treatment for vascular access site and access-related complications during transfemoral TAVR.

Objectives The study sought to examine the effect of coronary artery disease (CAD) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR). Background CAD is common in the TAVR population. However, there are conflicting data on the prognostic significance of CAD and its treatment in this population. Methods The authors analyzed 1,270 consecutive patients with severe aortic stenosis (AS) undergoing TAVR at 3 Israeli centers. They investigated the association of CAD severity (no CAD, nonsevere CAD [i.e., SYNTAX score (SS) 22]) and revascularization completeness (“reasonable” incomplete revascularization [ICR] [i.e., residual SS 8]) with all-cause mortality following TAVR using a Cox proportional hazards ratio model adjusted for multiple prognostic variables. Results Of the 1,270 patients, 817 (64%) had no CAD, 331 (26%) had nonsevere CAD, and 122 (10%) had severe CAD. Over a median follow-up of 1.9 years, 311 (24.5%) patients died. Mortality was higher in the severe CAD and the ICR groups, but not in the nonsevere CAD or “reasonable” ICR groups, versus no CAD. After multivariate adjustment, both severe CAD (hazard ratio: 2.091; p = 0.017) and ICR (hazard ratio: 1.720; p = 0.031) were associated with increased mortality. Conclusions Only severe CAD was associated with increased mortality post-TAVR. More complete revascularization pre-TAVR may attenuate the association of severe CAD and mortality.

Balloon pre-dilatation before transcatheter aortic valve replacement (TAVR) is performed at the discretion of the treating physician. Clinical data assessing the implications of this step on procedural outcomes are limited.We conducted a retrospective analysis of 1164 consecutive TAVR patients in the Israeli multicenter TAVR registry (Sheba, Rabin, and Tel Aviv Medical Centers) between the years 2008 and 2014. Patients were divided to those who underwent balloon pre-dilation (n=1026) versus those who did not (n=138).Rates of balloon pre-dilation decreased from 95% in 2008-2011 to 59% in 2014 (p for trend=0.002). Baseline characteristics between groups were similar except for more smoking (22% vs. 8%, p=0.008), less past CABG (18% vs. 26%, p=0.016), less diabetes mellitus (35% vs. 45%, p=0.01), and lower STS mortality scores (5.2±3.7 vs. 6.1±3.5, p=0.006) in the pre-dilatation group. The pre-dilation group included less patients with moderate to severely depressed LVEF (7% vs. 16%, p0.001) and higher aortic peak gradients (76.9±22.7mmHg vs. 71.4±24.3mmHg, p=0.01). Stroke rates were comparable in both groups (2.5% vs. 3%, p=0.8), but pre-dilation was associated with lower rates of balloon post-dilatation (9% vs. 26%, p0.001). On multivariate analysis, balloon pre-dilatation was not a predictor of device success or any post-procedural complications (p=0.07).Balloon pre-dilatation was not associated with procedural adverse events and may decrease the need for balloon post-dilatation. The results of the present study support the current practice to perform liberally balloon pre-dilatation prior to valve implantation.

Very little data exist on the impact of sex on aortic and arterial anatomy as relevant for transcatheter aortic valve implantation (TAVI).To investigate whether patients with severe aortic stenosis (AS) referred for TAVI display sex-specific differences in aortic root and ilio-femoral artery size.In 506 patients referred for pre-procedural CT evaluation before TAVI we performed a detailed assessment of aortic root anatomy: size of the annulus and the sinus of Valsalva (SoV), diameter of the sino-tubular junction (STJ), and distance of the coronary artery ostia to the aortic annulus plane; we also determined the dimensions of aorta, subclavian, and ilio-femoral arteries.Women had significantly smaller aortic root dimensions (annulus mean diameter: 22.9 ± 2.2 mm vs. 25.7 ± 2.7 mm, SoV mean diameter: 31.8 ± 4.2 mm vs. 36.3 ± 3.8 mm, STJ mean diameter: 26.3 ± 3.4 mm vs. 29.8 ± 4.2 mm) and lower left and right coronary artery ostia take-off (12.3 ± 2.4 vs. 14.1 ± 2.9 mm; 14.8 ± 2.6 vs. 17.1 ± 3.2 mm, respectively) than men (P 0.001 for all), even after adjustment for their smaller body surface area (BSA) and height. Dimensions of the ascending aorta, subclavian and ilio-femoral arteries were also significantly smaller in women, but not when adjusted for BSA.Women with severe AS had smaller aortic root dimensions even after correcting for their smaller body size and height, reflecting a sex-specific difference. In contrast, sex-related differences in aortic, subclavian, and ilio-femoral dimensions were fully explained by the smaller BSA of women.

Background The combination of a small aortic valve area valve area (AVA) and a low mean gradient (MG) severity pose a serious clinical challenge in the diagnosis of severe aortic stenosis (AS). While this discordance is frequently labeled “low-flow low-gradient AS”, there are two additional potential causes: underestimation of MG and underestimation of AVA. Purpose To investigate prevalence and root causes of discordant echocardiographic findings in symptomatic patients with AS and normal LV function by comparing Doppler data, invasive hemodynamic data, CT LV outflow tract size and calcium score. Methods and results We studied 67 severely symptomatic patients with AS and an LVEF>50%. Thirty patients (45%) had discordant echocardiographic findings (MG35 mmHg; in 5 it was >30 mmHg and only in 2 between 25 and 29 mmHg. In 6 of the 14 patients with underestimated MG, no right parasternal Doppler examination had been performed, LVOT VTI tracings were clearly suboptimal in 3 patients and 1 case was deemed inadequate due to poor imaging quality. LVOT area by echocardiography or by CT could not differentiate between Concordants and Discordants (p=0.3 and p=0.8 respectively) or between True and False Discordants (p=0.5 and p=0.6 respectively). While calcium score was similar in Concordants (2711±1159 AU) and False Discordants (2692±1136AU, p=0.96), it tended to be higher in Concordants (2711±1159 AU), when compared to True Discordants (1906±1284 AU, p=0.07). In patients with concordant echocardiographic findings calcium score levels of >3000 AU in men and >1600 AU in female had a positive predictive value (PPV) of 90% for the correct diagnosis of severe aortic stenosis. In patients with discordant findings the PPV was 80%. Conclusions 1) The majority of severely symptomatic AS patients with normal LV systolic function an echocardiographic AVA≤1.0 cm2 and a MG>30mmHg considered for TAVR have severe AS by calcium score. 2) In this patient population, discordant echocardiographic findings are in about half of the cases due to technical factors (“pseudo-discordance”) rather than due to true low flow low-gradient stenosis. 3) Pseudo-discordance is mainly due to mild-moderate underestimation of gradients, caused by a lack of reliable right parasternal tracings, rather than due to underestimation of valve area due to the echocardiographic circularity assumption in the presence of an elliptical LVOT. 4) The diagnosis of true low-flow AS cannot be established without a clear Doppler tracing from the right parasternal window. 5) Absent an adequate right parasternal window, patients should undergo CT assessment of calcium score.

Background: The risk of conduction system abnormalities (CSA) after transcatheter aortic valve implantation remains high. We aimed to evaluate the impact of mitral annular calcium (MAC) score on the development of CSA after transcatheter aortic valve implantation. Methods: Consecutive patients (n=168), with severe AoV stenosis, without prior CSA, underwent computed tomography transcatheter AoV implantation followed by device implantation; CoreValve (n=72) and SAPIEN (n=96). MAC, AoV, and left ventricular outflow tract calcium (Ca++) scores were quantitated from noncontrast ECG-gated computed tomography using Agatston method. The primary end point was a combination of complete left bundle branch block or high-degree atrioventricular block. Logistic regression was used to analyze the predictive value of Ca++ scores of different locations. Results: The primary end point was documented in 62% of the fourth quartile MAC score (>2700) patients as compared with 31% of the first quartile (P =0.03. Logistic regression analysis documented MAC score as an independent predictor either of primary end point as a continuous variable (odds ratio: 1.02, 95% [CI]: 1.00 – 1.03, p = 0.021) or as quartile cutoffs, whereas Q4 was a strong and independent predictor (odds ratio: 3.69, 95% [CI]: 1.37 – 9.95, p = 0.010). Conclusions: MAC score was found to be an independent predictor of CSA in patients undergoing transcatheter aortic valve implantation without preexisting CSA. Therefore, the current study suggests that patients with high MAC score category (fourth MAC score quartile) should be considered at high risk for CSA, warranting closer monitoring. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02023060.

Background About a decade past the first transcatheter aortic valve implantation (TAVI), data are limited regarding temporal trends accompanying its evolution from novel technology to mainstream therapy. We evaluated these trends in a large multicenter TAVI registry. Hypothesis TAVI is changing and improving with time. Methods Patients who underwent TAVI between January 2008 and December 2014 at 3 high-volume Israeli centers were divided into 5 time quintiles according to procedure date. Outcomes were analyzed and reported according to Valve Academic Research Consortium-2. Results A total of 1285 patients were studied (43% male; mean age, 83 ± 3 years; mean Society of Thoracic Surgeons [STS] score, 5.5 ± 3.6). Over time, there was a shift toward treating patients at lower STS score, increased use of conscious sedation and transfemoral approach, and decreased use of balloon predilatation. The balloon-expandable to self-expandable valve utilization ratio decreased, the valve-in-valve experience increased from 4% to 17% of all TAVI volume, and length of hospital stay was halved (P = 0.006). Kaplan-Meier survival curves showed gradual decrease in mortality risk (P = 0.031), but there was no significant 1-year mortality decrease by multivariable analysis. Each year increment was associated with an adjusted 20%, 15%, and 12% decrease in new pacemaker obligation (P = 0.004), new pacemaker obligation or left bundle branch block (P = 0.008), and in-hospital infections (P = 0.082), respectively. Conclusions Temporal trends accompanying TAVI evolution include its utilization in lower-risk patients, procedural simplification, improved overall survival, decreased pacemaker obligation, and shorter hospital stay.

AIMS Albumin is a marker of frailty. Scarce data are available on correlations between frailty-related parameters and outcomes in patients undergoing TAVI. This study sought to evaluate the relation between albumin and mortality in TAVI candidates. METHODS AND RESULTS A total of 150 patients (mean age 81±6 years) undergoing TAVI were included in the study. Patients with pre-procedural albumin >4 g/dl (>40 g/L) (n=71) were compared to those ≤4 g/dl (≤40 g/L) (n=79). The cut-off value of 4 g/dl (40 g/L) was based on the mean value of albumin in the patients included in the study. During a mean follow-up of 2.1 years the survival rate was 72%. Patients in both groups had similar baseline characteristics. The 2.1-year mortality was higher in the low albumin group compared with the normal albumin group (35% vs. 19%, p=0.01). Multivariate analysis indicated that low pre-procedural albumin was independently associated with a more than twofold increase in 2.1-year all-cause mortality (p=0.01, HR=2.28; 95% CI: 1.17-4.44). Low post-procedural serum albumin remained a strong parameter correlated with all-cause mortality (HR=2.47; 95% CI: 1.28-4.78; p

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

We evaluated temporal trends in gender-related differences in patients who underwent transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic stenosis from a multicenter TAVI registry during the years 2008 to 2016. Our final cohort included 1,159 males and 1,370 females, with a median follow-up of 2.3 (IQR 1.2, 4.4) years. For temporal trends analysis, the entire population was divided according to period of procedure: 2008 to 2012 and 2013 to 2016. During the 2008 to 2012 period, the rates of in-hospital aortic paravalvular leak, myocardial infarction, pacemaker implantation, and stroke were higher among men than women, but became comparable between the gender during the 2013 to 2016 period. Multivariate analysis demonstrated that female patients who underwent TAVI between the years 2008 and 2012 had a 26% lower risk of death compared with male patients (p = 0.004), but there were no gender-related differences in mortality risk between the years 2013 and 2016 (hazard ratio 1.07, p = 0.6; gender-by-year of procedure, p = 0.027 for interaction). In conclusion, the favorable long-term prognosis described in female patients during the earlier TAVI period seemed to diminish with contemporary TAVI. This might be attributed to current technological advances and improved valve sizing, with a more significant benefit in favor of male patients.

Background The outcomes of patients with diabetes mellitus (DM) who are referred to surgical aortic valve replacement are poor in comparison to non-diabetic (ND) patients. However, the outcome of diabetic patients referred to transcatheter aortic valve replacement (TAVR) is less established. Further, DM and AS are both associated with left ventricular hypertrophy. It is not clear if alleviation of AS results in greater degree of reverse remodeling in DM patients in comparison to ND. We aim to evaluate if diabetes mellitus has an impact on TAVR outcome and remodeling patterns. Methods All consecutive patients who underwent TAVR (2007–2012) were included in this analysis. A comparison of baseline, procedural, post-procedural outcomes and echocardiographic left-ventricle mass indices was performed between DM and ND patients. Results DM was prevalent in 165 of 499 (33.0%) consecutive patients who underwent TAVR. DM patients were younger, weighed more, had higher rates of renal insufficiency and larger caliber peripheral vessels. Other than that, no disparities were noted in baseline characteristics. Procedural aspects were mostly similar between the groups but ND patients had higher rates of both vascular complications and bleeding. This did not translate into statistically significant differences in mortality both at 30days and at 1year (DM 6.7% vs. ND 10.5%; p =0.16 and DM 22.4% vs. 25.7%; p =0.48, respectively). Incidences of reverse remodeling patterns were similar between the two groups. Conclusion TAVR outcome is probably driven by baseline characteristics and post-operative complications while diabetes itself is not associated with poor outcome after TAVR.

Background Acute kidney injury (AKI) was demonstrated to adversely affect outcome in patients undergoing transcatheter aortic valve implantation (TAVI). We compared predictors for AKI and associated outcomes according to various definitions among patients undergoing TAVI in a tertiary medical center. Methods Two-hundred and seventeen TAVI patients were evaluated for the occurrence of AKI according to Kidney Disease Improving Global Outcomes (KDIGO)/Valve Academic Research Consortium (VARC-2) and Risk Injury Failure Loss End-Stage (RIFLE) definitions. Multivariate analysis was conducted to assess predictors of AKI. Cox hazard ratio was used to evaluate long-term mortality in this patient population. Results AKI occurred in 23 and 21% of patients (n = 49, n = 46) according to KDIGO/VARC-2 and RIFLE definitions, respectively, with an approximate 10% of disagreement between both systems. Predictors of AKI according to KDIGO/VARC-2 were chronic obstructive pulmonary disease (COPD; OR = 2.66, P = 0.01), PVD (OR = 3.45, P = 0.02) and a lower baseline eGFR (OR = 1.03 per 1 mL/min/1.73 m2 decrease, P = 0.02). While BMI (OR = 1.12, P = 0.01), prior ischemic heart disease (OR = 2.35, P = 0.04) and COPD (OR = 2.18, P = 0.04) were associated with AKI as defined by the RIFLE definition. AKI defined by either classification was independently associated with long-term mortality (HR = 1.63, for the KDIGO/VARC-2 definition and HR = 1.60 for RIFLE definition, P = 0.04 for both models), with borderline superiority of the KDIGO/VARC-2 classification. Conclusions Different clinical characteristics predict the occurrence of AKI after TAVI when RIFLE and KDIGO/VARC-2 classifications are used. Both classification systems of AKI identify patients with increased risk for long-term mortality, with superiority of the KDIGO/VARC-2 definition, which should be used for AKI grading. © 2015 Wiley Periodicals, Inc.

Objective To assess the rate of Vascular complications in steroid treated patients undergoing transfemoral aortic valve implantation (TAVI). Background Steroid therapy has been associated with increased post-surgical bleeding. Vascular complications are a major concern in patients undergoing TAVI. However, the effect of corticosteroids on vascular complications has not been assessed in these patients. Methods We conducted a retrospective analysis of 220 consecutive patients undergoing transfemoral TAVI at our institute between 2009 and 2013. Patients who were on steroids at the time of the procedure (n = 25) were compared with those who were not (n = 195). Results Baseline characteristics between groups were similar except for greater incidence of chronic renal failure (52 vs. 25%, P = 0.05) and lower left ventricular ejection fraction (50.3 vs. 55.8%, P = 0.037) in the steroid group. The rate of procedural success and nonvascular complication were similar in both groups with the exception of more temporary AV block in the steroid group (24 vs. 8%, P = 0.016). Patients treated with steroids had significantly more minor vascular complication (44 vs. 23%, P = 0.024), and significantly more femoral artery stenosis (16 vs. 5%, P = 0.036), occlusion (8 vs. 1%, P = 0.014), need for femoral artery percutaneous transluminal angioplasty (PTA) (32 vs. 12%, P = 0.009), and femoral artery PTA or stenting (32% vs. 15%, P = 0.031). On multivariate analysis steroid treatment was the only predictor of minor vascular complications (RR=2.65, 95% CI 1.04-6.8, P = 0.042). Conclusions Concurrent corticosteroid treatment is associated with a higher rate of minor vascular complication following transfemoral TAVI. Operators should be aware of this risk when assessing patients for the procedure. © 2015 Wiley Periodicals, Inc.

Limited amount of data suggest that patients with aortic stenosis and pulmonary hypertension (PH) who undergo transcatheter aortic valve replacement (TAVR) experience decrease in PH postprocedure. Inconsistent use of systolic pulmonary artery pressure cut-off values in previous studies limits our ability to draw meaningful conclusions regarding the prognostic role of PH in assessment of TAVR candidates. A total of 415 consecutive patients who underwent TAVR were included in the present study. Two groups were compared based on receiver-operating characteristics curve analysis for the best SPAP value to predict outcome, yielding 2 study groups of no/mild PH (≤50 mm Hg; n = 172, 41%) versus moderate/severe PH (>50 mm Hg; n = 243, 59%). Demographics and co-morbidities were comparable between the 2 groups; however, right-sided cardiac failure (35% vs 19.8%, p = 0.02) and mitral regurgitation (18.4% vs 8.6%, p = 0.007) were more frequent in patients with moderate/severe PH. Procedural characteristics and complications were comparable between the groups. Although there was an early overall decrease in SPAP postprocedure, only 26% of moderate/severe patients with PH experienced a significant decrease in SPAP (>10 mm Hg). The 30-day (14.5% vs 7.4%, p = 0.02) and 1-year mortality (30.8% vs 21%, p = 0.02) was higher in moderate/severe patients with PH. In multivariate analysis, systolic pulmonary artery pressure and chronic lung disease were identified as independent predictors for mortality at 1 year. PH is a frequent co-morbidity in patients with severe aortic stenosis who underwent TAVR. Significantly elevated pulmonary artery pressures at baseline may serve as a poor prognostic factor when performing preprocedural assessment of the patients.

Coronary artery size is increased in patients with left ventricular hypertrophy (LVH), thus accommodating higher flow rates necessary to perfuse an increased muscle mass; yet despite an absolute increase in myocardial blood flow, flow per unit mass is reduced, rendering the myocardium susceptible to

In the era prior to transcatheter aortic valve replacement (TAVR), several studies have suggested that women have been less frequently referred to surgical aortic valve replacement (SAVR) due to various reasons (1). At age younger than 65 years, gender does not seem to play a major role in referral to SAVR. However, among octogenarians and nonagenarians, women were unequally denied of SAVR (2). In the TAVR era things have changed, in most TAVR studies, female patients are equally represented (3,4).

Advanced chronic kidney disease (CKD) is an independent predictor of mortality in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to identify predictors of 1-year mortality in patients after TAVI stratified by the presence or absence of advanced CKD (defined as estimated glomerular filtration rate

The Israel Heart Society is a member of the European Society of Cardiology, and the Israeli Working Group of Interventional Cardiology is an active participant in EAPCI. The aim of this manuscript is to provide a snapshot of cardiac interventions performed in the State of Israel during the period 2010-2015. Data for this manuscript were collected via collaboration with the National Diseases Registries Unit of the Israel Center for Disease Control. During the survey period, the Israeli population increased by 7% but only one additional hospital with an active cardiac catheterisation laboratory was opened. The vast majority of the percutaneous procedures are performed in public hospital settings. Total coronary angiography procedures remained stable throughout the survey period, and the percentage of PCI out of total coronary angiography procedures remained approximately 50% throughout the survey period. More than 90% of the PCI procedures were performed using stent deployment, and the use of drug-eluting stents increased significantly during the survey period from 46% in 2010 to 92% in 2015. The number of TAVI procedures increased dramatically, by more than sixfold, from 130 procedures in 2010 to 851 procedures in 2015 (with 130 implants/million population at Q4 of 2015). The vast majority of interventional cardiology procedures are funded by the governmental healthcare providers, and all the citizens of the country have access to the most advanced cardiac interventions. If corrected for the increase in the population, the volumes of coronary interventions are decreasing throughout the country. However, structural heart disease interventions, and specifically valvular interventions, are growing rapidly and this trend is expected to continue in the near future.

Transcatheter aortic valve implantation (TAVI) has been widely used for the treatment of aortic stenosis. Most pivotal studies of TAVI included patients with a mean age of over 80 years old. Many young patients may also be considered for TAVI because of severe co-morbidities. We sought to describe a group of patients undergoing TAVI at an age below 70 and to compare them with older patients undergoing the procedure. This study included 1,324 consecutive patients from a 3-center TAVI registry from 2008 to 2014. Patients were divided according to age into 3 groups: patients aged 70 years and below, patients between the ages of 71 and 80, and patients 81 years and older. Patients in the younger group had higher body mass index (p0.001), higher proportion of previous stroke (p = 0.05), peripheral vascular disease (p = 0.03), and diabetes mellitus (p0.001). Thirty percent of patients in the younger group had functional class IV. Corticosteroids treatment was 5-fold higher in the younger group (p0.001). Average valve area was lower in the older group (p = 0.004). Thirty-day mortality was similar between the 3 groups. We found no difference in the rate of in-hospital complications. One-year all-cause mortality rate of patients aged 70 years, 71 to 80 years, and80 years was 7.6%, 7.5%, and 12.6%, respectively, p = 0.01. In conclusion, younger patients undergoing TAVI exhibited higher prevalence of risk factors and co-morbidities that probably explain the decision to perform TAVI rather than surgical aortic valve replacement. Nevertheless, the 1-year mortality of these patients was significantly lower than in older patients.

Objectives To assess the prevalence at baseline, postprocedural incidence, and clinical impact of atrial fibrillation (AF) on consecutive patients undergoing transcatheter aortic valve implantation (TAVI). Background AF in patients with aortic stenosis (AS) is an independent risk factor for adverse outcome. Despite the evidence for high AF prevalence and the increased risk in surgical series, there are limited data with regard to AF and its impact on outcome after TAVI. Methods Consecutive patients with symptomatic, severe AS were analyzed and categorized according to prevalence of AF on initial admission (baseline AF) and according to the development of new AF postprocedure (postprocedure AF). A total of 371 patients were included in the analysis; of them, 143 (39%) had AF at baseline. Results No difference in procedural and hospital outcome was found between groups; however, baseline AF patients did have higher 1-year mortality (28.8 vs. 18%, P = 0.01). Of the patients with no baseline AF, 46 patients (20%) developed new, postprocedural AF during their hospital stay. Inhospital death was twice as frequent in patients with new, postprocedure AF, however, this difference did not reach statistical significance (13 vs. 6.7%, P = 0.22). Procedure hemodynamic instability (OR 9.3; 95% CI 1.5–59), and transapical access (OR 4.96, 95% CI 1.9–13.2) were independent predictors for development of new AF. Conclusions Baseline and postprocedure AF are common in AS patients undergoing TAVI. However, only postprocedure AF is associated with a prolonged and more complicated hospital course. AF is associated with poor long-term, but not short-term, mortality. © 2014 Wiley Periodicals, Inc.

Objective This study aimed to report the outcomes of African Americans (AAs) in the US undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). Background Compared to Caucasians, AAs are reported to have poorer outcomes from most cardiovascular diseases, including high complication rates after surgical aortic valve replacement. The outcomes of AAs undergoing TAVR are not well established. Methods Consecutive patients who underwent TAVR were included in this analysis. Patients' baseline characteristics, procedural data, in-hospital- and long-term outcomes were recorded and a comparison was performed between the AA and Caucasian cohorts. Results In a cohort of 469 consecutive patients, 51 (10.8%) were AA and 345 (74.5%) were Caucasian. The remaining patients (n = 73; 15.3%) self-reported their race as “unknown” or were from other races. Most baseline characteristics were similar between the two groups except for less men (33.3 vs. 50.1%; P = 0.016), a lower mean left ventricular ejection fraction (48.85 ± 16.35 vs. 53.24 ± 13.41%; P = 0.04) and lower rates of atrial fibrillation in AAs (15.7 vs.45.4%; P

Re-operation after coronary artery bypass grafting (CABG) is associated with increased risk for morbidity and mortality. Transcatheter aortic valve implantation (TAVI) is an alternative for patients with aortic stenosis, but the outcomes of patients with a history of CABG are unknown. The aim of this study was to explore the association between previous CABG and the outcome of patients undergoing TAVI. Out of 372 consecutive patients who underwent TAVI from 2007 to 2013, 122 (32.8%) had previous CABG, whereas 250 (67.2%) did not. A comparison was made between groups. Subgroup analysis compared patients with and without previous CABG in 3 patient subsets: inoperable, operable, and those who underwent transapical TAVI. Patients with previous CABG were younger (81.99±6.78 vs 84.81±7.06 years, respectively, p0.001). These patients also had more high-risk features (e.g., peripheral vascular disease, previous myocardial infarction, past cerebrovascular disease, and lower average left ventricular ejection fraction (p0.05 for all). Procedural aspects were mostly similar between groups. No disparities in mortality rates at 1 year were noted (22.1% vs 21.6%, respectively, p=0.91). Subgroup analyses yielded similar outcomes for all 3 groups. In conclusion, although patients with previous CABG present with more high-risk features, they share similar short- and long-term outcomes with patients without previous CABG, irrespective of their surgical risk. This includes patients who underwent transapical access. TAVI in patients with previous CABG is safe and does not confer a significant risk for adverse outcome.

Objective This study aimed to explore the correlates for mortality in patients treated with both primary percutaneous coronary intervention (PCI) and intra-aortic balloon pump counter-pulsation (IABP). Background Acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) is associated with high mortality rates. Methods From a cohort of patients with AMI, treated with both primary PCI and IABP and who met strict definitions for CS to identify correlates associated with mortality, the study compared patients who died in-hospital to those who survived to discharge. Results A cohort of 93 patients met the inclusion/exclusion criteria. Of them, 66.7% were male, and the average age was 64.96 ± 13.06 years. The overall in-hospital mortality rate for this cohort was 33%. The baseline characteristics were balanced save for older average age and left ventricular ejection fraction in those who died (p = 0.049 and p = 0.014, respectively). Insertion of IABP pre-PCI and cardiac arrest at the catheterization lab were more frequent in those who died (p = 0.027 and p = 0.008, respectively). The insertion of IABP pre-PCI, cardiac arrest at the cath lab, and lower ejection fraction were correlated with in-hospital mortality (ORs 2.68, 5.93, and 0.02, respectively). Conclusions In the era of primary PCI and IABP as standard of care in AMI complicated by CS, patients with low EF, those who necessitate IABP insertion pre-PCI, and those who necessitate cardiopulmonary resuscitation during PCI are at higher risk for in-hospital mortality and should be considered for more robust hemodynamic support devices with an attempt to improve their prognosis.

Objectives The study aimed to evaluate the impact of chronic lung disease (CLD) on outcomes of severe aortic stenosis patients across all treatment modalities. Background Outcomes of patients with CLD undergoing transcatheter aortic valve replacement (TAVR) have not been systematically examined. Methods All patients who underwent TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve) trial, including the continued access registry (n = 2,553; 1,108 with CLD), were evaluated according to CLD clinical severity. Additionally, outcomes of CLD patients included in the randomization arms of the PARTNER trial were compared: Cohort A patients (high-risk operable) treated by either TAVR (n = 149) or surgical aortic valve replacement (SAVR); (n = 138); and Cohort B patients (inoperable) treated by either TAVR (n = 72) or standard therapy only (n = 95). Results Among all TAVR-treated patients, at 1-year follow-up, patients with CLD had higher mortality than those without it (23.4% vs. 19.6%, p = 0.02). Baseline characteristics of CLD patients who underwent TAVR were similar to respective controls. In Cohort A, 2-year all-cause death rates were similar (TAVR 35.2% and SAVR 33.6%, p = 0.92), whereas in Cohort B, the death rate was lower after TAVR (52.0% vs. 69.6% after standard therapy only, p = 0.04). Independent predictors for mortality in CLD patients undergoing TAVR included poor mobility (6-min walk test Conclusions Although patients with CLD undergoing TAVR had worse outcomes than patients without CLD, TAVR performed better in these patients than standard therapy and was similar to SAVR. However, CLD patients who were either poorly mobile or oxygen-dependent had poor outcomes. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894 )

The aim of this study was to identify predictors of 30-day and midterm mortality after transcatheter aortic valve implantation (TAVI) by means of a systemic review. TAVI was demonstrated to be safe and efficacious in patients with severe aortic stenosis. An accurate estimation of procedural risk of these patients represents an actual challenge. The PubMed and Cochrane Collaboration databases were systematically searched for studies reporting on the incidence and independent predictors of 30-day and midterm mortality. Adverse events were pooled with random effect, whereas independent predictors are reported as odds ratios (ORs) with 95% confidence intervals (CIs). A total of 25 studies with 8,874 patients were included (median age 82.5 +/- 1.5 years, 54.6% women). At 30 days, 7.5% of patients (n = 663) died. At midterm follow-up (median 365 days, interquartile range 267 to 365 days), the cumulative mortality rate was 21.6% (n = 1,917). Acute kidney injury (AM) stage >= 2 (OR 18.0, 95% CI 6.3 to 52), preprocedural hospitalization for heart failure (OR 9.4, 95% CI 2.6 to 35), periprocedural acute myocardial infarction (OR 8.5, 95% CI 2.6 to 33.5), and increased pro-brain natriuretic peptide (pro-BNP) levels (OR 5.4, 95% CI 1.7 to 16.5) were the most important independent predictors of 30-day mortality. Increased proBNP levels (OR 11, 95% CI 1.5 to 81), AKI stage 3 (OR 6.8, 95% CI 2.6 to 15.7), left ventricular ejection fraction

Routine use of embolic protection devices (EPDs) for stroke prevention during transcatheter aortic valve replacement (TAVR) is controversial. Identifying patients at high risk for periprocedural cerebrovascular events (CVEs) may facilitate effective patient selection for EPDs and stroke prevention.

Objective To evaluate the axial integrity of different coronary stents using intravascular ultrasound (IVUS). Background Longitudinal stent deformation was recently reported. Methods Consecutive patients who underwent IVUS analysis after drug-eluting stent (DES) implantation for de novo coronary lesions were evaluated. Stent length was compared with label length for calculation of absolute change and relative difference (absolute change divided by label length). Results A total of 233 DES utilizing five different platforms were included. The median absolute change in stent length was 0.90 mm (interquartile range [IQR] 0.48–1.39) and the relative difference was 5.24% (IQR 2.55–8.29). There was no significant difference among the groups in median absolute or relative change: Cypher 0.89 mm/3.89%, Taxus 0.88 mm/5.39%, Endeavor 1.16 mm/6.77%, Xience V 0.86 mm/5.80%, and PROMUS Element 0.79 mm/5.34% (P = 0.085, P = 0.072, respectively). Multivariate logistic regression revealed that the Cypher stent was independently correlated with a lower change in length, whereas stent label length and deployment pressure were correlated with higher absolute change. Conclusion The axial integrity of DES platforms examined in vivo was high, with only mild changes in stent length after implantation. While there are differences between first- and second-generation DES, axial integrity among second-generation DES was similar. © 2013 Wiley Periodicals, Inc.

Marriage confers various health advantages in the general population. However, the added value of marriage among patients who undergo percutaneous coronary intervention (PCI) beyond the standard cardiovascular risk factors is not clear. This study aimed to assess the effects of marital status on outcomes of patients undergoing elective or urgent PCI.Clinical observational analysis of consecutive patients undergoing elective or urgent PCI from 1993 to 2011 was performed. Patients were stratified by marital status, comparing married to unmarried patients. Clinical outcome up to 12 months was obtained by telephone contact or office visit. A total of 11,216 patients were included in the present analysis; 55% were married and 45% unmarried.Significant differences in baseline characteristics were noted, including a lower prevalence of hypertension (86% vs 88%), diabetes (34% vs 38%), and smoking (19% vs 25%) among married vs unmarried patients, respectively (P.001). However, married patients had a higher prevalence of hypercholesterolemia and family history of coronary artery disease. Early and late major adverse cardiac event rates were significantly lower for married vs unmarried patients up to 1 year (13.3% vs 8.2%, P.001). Married status was independently associated with improved outcome in multivariable analysis (hazard ratio 0.7, 95% CI 0.6-0.9).Married patients who undergo urgent or elective PCI have superior short- and long-term outcomes up to 1 year when compared with unmarried patients. These benefits persist after adjustment for multiple traditional cardiovascular risk factors.

The safety and efficacy outcomes of stent overlap with second-generation drug-eluting stents (DES) have not been well established. This study aimed to compare the 1-year clinical outcomes of overlapping everolimus-eluting stents (EES) with those of overlapping first-generation DES. This retrospective analysis included 350 patients treated with overlapping EES (169 patients with 237 lesions), sirolimus-eluting stents (SES, 102 patients with 252 lesions), or paclitaxel-eluting stents (PES, 79 patients with 182 lesions). End points were major adverse cardiovascular events (MACE: defined as the composite of death, myocardial infarction, or target lesion revascularization), target vessel revascularization, and definite stent thrombosis at 1 year. During a follow-up of 1 year, overall MACE occurred in 6.5% of EES-, 16.8% of SES-, and 10.1% of PES-treated patients (p = 0.026). Myocardial infarction was lowest in the EES group versus SES and PES groups (0 vs 1.0% vs 2.5%, respectively; p = 0.080), and mortality was similar (3.6% vs 9.0% vs 5.1%, p = 0.162). The EES patients showed a trend toward lower rates of 1-year target lesion revascularization (3.1% vs 8.2% vs 6.5%, p = 0.181) and target vessel revascularization (3.7% vs 9.1% vs 11.7%, p = 0.051) compared with the SES- and PES-treated patients. The cumulative incidence of definite stent thrombosis was lowest in the EES group (0 for EES vs 3.9% for SES vs 2.5% for PES, p = 0.014). In conclusion, stent overlap with EES versus first-generation DES was associated with lower rates of MACE and stent thrombosis. Our results suggest that the use of EES when deploying overlapping stents is effective and safe.

Objective This study aimed to compare the safety and efficacy of everolimus-eluting stents (EES) to first-generation drug-eluting stents (DES) in multivessel disease (MVD). Background Second-generation EES have demonstrated superiority over first-generation DES for single-vessel disease, although the merits of EES in MVD are less established. Methods A cohort of 1,285 patients (3,124 lesions) with ≥2 diseased vessels were treated with either first-generation DES (n = 1,002) or EES (n = 283). The rates of death, myocardial infarction, target lesion revascularization, target vessel revascularization, definite stent thrombosis, and major adverse cardiac events (MACE), defined as the combined incidence of target vessel revascularization, death, and non-fatal myocardial infarction, were compared at 1 year. Results Baseline characteristics were similar except for a lower left ventricular ejection fraction and a lower incidence of stable angina pectoris in the first-generation DES group (P = 0.001 and 0.013, respectively). At 1 year, the MACE rate was lower in the EES group (9.5P% vs. 15.7%; P = 0.01). Multivariable analysis demonstrated that EES use predicted a higher chance of freedom from MACE at 1 year (hazard ratio 0.58 [0.38–0.87]; P = 0.009; 95% confidence interval). Conclusions The use of EES in patients with MVD is safe with signals for improved effectiveness compared to first-generation DES. Randomized trials comparing new-generation DES to coronary artery bypass grafting surgery are warranted.

Background Drug-eluting stents have shown promising clinical results in the treatment of acute coronary syndrome (ACS) patients. We aimed to evaluate the long-term outcome of Endeavor® zotarolimus-eluting stent (EZES) implantation in an ACS population and to compare these results with those obtained in patients treated with sirolimus-eluting (SES) and paclitaxel-eluting stents (PES). Methods This prospective study included 1481 consecutive ACS patients (72% myocardial infarction, age 65 ± 13 years, 62% male) treated with a drug-eluting stent: (SES, n = 925; PES, n = 417; EZES, n = 139). The primary end point was major adverse cardiac events (MACE) at 2 years, defined as the composite of death, myocardial infarction, and target vessel revascularization. Two-year follow-up was obtained in all patients. Results Baseline clinical and angiographic characteristics were mostly similar. Unadjusted 2-year MACE and death rates were lower in the EZES group than in the SES and PES groups (MACE: 18.7% vs. 25.3% vs. 30.2%, p = 0.02; death: 10.1% vs. 16.4% vs. 22.2%, p = 0.002, respectively). The rate of definite stent thrombosis at 2 years was lower in the EZES group without statistically significant difference (0.7% vs. 2.9% SES vs. 1.7% PES, p = 0.16). After adjusting for differences in baseline characteristics, EZES use was an independent correlate for 2-year MACE (vs. SES, hazard ratio 0.65, p = 0.049; vs. PES, hazard ratio 0.57, p = 0.01). Conclusion In an ACS patient population, a lower long-term MACE rate was observed in patients treated with an EZES when compared to treatment with first-generation drug-eluting stents. The use of EZES in contemporary practice has excellent long-term outcome in terms of low rates of revascularization and clinical events.

Paravalvular regurgitation is a common, potentially life-threatening complication of transcatheter aortic valve replacement. Previous studies report a 65%–94% rate of paravalvular leakage after transcatheter implantation, mostly of mild degree. The rate of significant (≥ + 2) paravalvular regurgitation varies in large clinical trials, and is associated with worse clinical outcome. There is less agreement regarding the significance of mild regurgitation (grade 1 +). There are anatomical and procedural correlates for paravalvular leak—most importantly, severe valve calcification, patient prosthetic mismatch, and device malposition. The following review details the current knowledge on paravalvular regurgitation after transcatheter aortic valve replacement, including diagnosis, correlates, clinical outcome, preventive and therapeutic strategies related to this complication.

The incidence and prognostic implication of myocardial injury after transcatheter aortic valve replacement (TAVR) have not been consistently studied. We aimed to assess the incidence and extent of myocardial injury after TAVR performed using transfemoral and transapical approaches. The clinical data from patients with aortic stenosis who underwent TAVR were retrospectively analyzed. The myocardial necrosis markers cardiac troponin I and creatine kinase (CK)-MB were assessed during hospitalization. Of the 150 TAVR patients, 95% and 50% had an abnormally elevated cardiac troponin I and CK-MB level, respectively. The transapical patients had significantly greater elevations of both cardiac troponin I (13.8 ± 14.0 vs 2.5 ± 5.8 ng/ml, p0.001) and CK-MB (28.4 ± 24.2 vs 7.4 ± 8.6 ng/ml, p ≤0.001). On receiver operating curve analysis, postprocedural CK-MB (twofold increase) had high predictive power for 30-day mortality (area under the curve 0.85, p0.001). Patients with high CK-MB levels had greater rates of postprocedural kidney injury (22% vs 6%, p = 0.026), in-hospital (22% vs 0%, p0.001), 30-day (27% vs 1.5%, p0.001), and 1-year mortality (41% vs 18%, p = 0.01). Baseline renal failure and no β-blocker treatment on admission were independent predictors of an elevated postprocedural CK-MB level. In conclusion, a cardiac biomarker increase after TAVR was common and more frequent among transapical access patients. A twofold increase (7 ng/ml) in CK-MB after transfemoral TAVR was a surrogate for poor long-term outcomes.

The CardioMEMS Champion Heart Failure Monitoring System (CardioMEMS, Atlanta, Georgia) is a permanently implantable pressure measurement system designed to wirelessly measure and monitor pulmonary artery (PA) pressure and heart rate in heart failure (HF) patients to guide ambulatory HF management and to reduce HF hospital stays. On December 8, 2011, the Food and Drug Administration (FDA) Circulatory System Device Panel reviewed the CardioMEMS Champion HF Monitoring System premarket approval (PMA) application. The majority of Panel members agreed that that the discussed monitoring system is safe for use in the indicated patient population. However, new information reported by the FDA with regard to preferential support in management of patients in the treatment group raised concerns among the Panel members with regard to potential bias in analyzing the efficacy of the device itself. Additionally, Panel members raised concerns with regard to the efficacy of the device in certain patient subpopulations. Hence, most Panel members decided that there was not reasonable assurance that the discussed monitoring system is effective. This summary aims to describe the discussions and recommendations made during this meeting.

Although second-generation everolimus-eluting stents (EESs) have demonstrated superiority over first-generation paclitaxel-eluting stents for a broad subset of patients and lesions, it is unclear whether the same applies to sirolimus-eluting stents (SESs). The present study compared the long-term clinical outcomes between EESs and SESs in patients with small coronary artery disease. A cohort of 643 patients treated with EESs (220 patients with 245 lesions) or SESs (423 patients with 523 lesions) in small vessel lesions (defined as those receiving stents ≤2.5 mm) were retrospectively analyzed. The end points included target lesion revascularization, target vessel revascularization, major adverse cardiovascular events (all-cause death, myocardial infarction, or target lesion revascularization), and definite stent thrombosis at 1 year of follow-up. The baseline characteristics were generally similar between the 2 groups, except that more systemic hypertension was seen in the EES group and more patients had a family history of coronary artery disease in the SES group. The 1-year target lesion revascularization (5.6% vs 4.8%, p = 0.68) and target vessel revascularization (5.6% vs 7.6%, p = 0.33) rates showed no significant differences between the EES and SES groups. Overall major adverse cardiovascular events occurred in 9.1% of the EES- and 8.6% of SES-treated patients (p = 0.83). This similar major adverse cardiovascular events rate remained after adjustment. The rate of stent thrombosis was 0% in the EES group and 1.2% in the SES group (p = 0.17). In conclusion, EESs demonstrated comparable clinical outcomes to those of SESs in small vessel interventions. The absence of stent thrombosis among patients treated with EESs suggests a good safety profile for this second-generation drug-eluting stent, which should be carefully studied in a larger series of patients with small vessel disease.

Objectives This study aims to determine how excimer laser coronary atherectomy (ELCA) performs in the drug-eluting stent (DES) era. Background For more than 20years, ELCA has been used for coronary intervention. With developments in the coronary intervention field, the role of ELCA is in question. Methods The study includes 119 patients with 124 lesions who underwent percutaneous coronary intervention (PCI) with ELCA in our institution from January 2004 to May 2011. Results The main indications for ELCA use were saphenous vein graft (SVG) (45 lesions), acute myocardial infarction (AMI) (7 lesions), chronic total occlusion (CTO) (32 lesions), in-stent restenosis (ISR) (15 lesions), and calcified de-novo lesions (25 lesions). High success rates were recorded for the SVG, AMI, CTO, ISR, and calcified lesion indications (91.1%, 85.7%, 93.8%, 86.7%, and 80%; respectively). ELCA related complications were reported in 10 patients (8%); four dissections, three no-reflow phenomena, two perforations, and one thrombus formation. Conclusion ELCA is an alternative solution with acceptable performance in the treatment of complex coronary lesions not ideally suitable for balloon angioplasty.

Drug-eluting stents have shown promising clinical results in the treatment of coronary artery disease, including in women. Studies with first-generation drug-eluting stents, however, have reported higher rates of stent thrombosis (ST). The aim of this study was to evaluate the safety and efficacy of second-generation everolimus-eluting stents (EES) versus first-generation sirolimus-eluting stents (SES) in women. The study included 1,649 women; 1,152 (70%) received SES and 497 (30%) received EES. In-hospital and 1-, 6-, and 12-month clinical outcomes were analyzed and compared. Correlates of major adverse cardiac events and ST were identified. Baseline clinical characteristics were similar between stent types, although more peripheral vascular disease and family history of coronary artery disease were seen in the SES group, while more unstable angina pectoris at initial diagnosis was more prevalent in the EES group. The EES group had more type C and distal lesions. There was a higher rate of target vessel revascularization and major adverse cardiac events in the SES group (14.7% vs 10.8%, p = 0.04) at 1 year. ST tended to be higher in the SES group (1.5% vs 0.4%, p = 0.06) at 6 and 12 months. After adjustment, multivariate analysis indicated that the EES group was less likely to have target vessel revascularization and major adverse cardiac events (hazard ratio 0.67, 95% confidence interval 0.47 to 0.95, p = 0.024) and had lower rates of ST (hazard ratio 0.09, 95% confidence interval 0.01 to 0.70, p = 0.022) at 1 year. In conclusion, contemporary use of EES in women is associated with improvement in efficacy and safety profiles compared to SES; however, a large randomized trial is needed to confirm this conclusion.

Background Surgical retroperitoneal access to the iliac artery may provide an alternative route for transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis and prohibitively small common femoral arteries. Methods Consecutive patients undergoing TAVR via the femoral approach were divided into two groups; standard percutaneous access (n=103) and surgical retroperitoneal access (n=15) for patients in whom dilators could not be advanced without resistance. For retroperitoneal access, proximal groin vessels were exposed surgically and direct puncture was performed. The sheath was tunneled from the level of the initial inguinal puncture site in order to achieve coaxial entry of the sheath into the vessel. Results Baseline characteristics were similar in both groups. Procedural characteristics were insignificantly different between groups; although, procedure time was longer (34min), while fluoroscopy time and contrast utilization were lower in the retroperitoneal access group. There was no outcome difference between groups. Conclusions Surgical retroperitoneal access is a reasonable alternative for transcatheter aortic valve replacement in high-risk patients with aortic stenosis who have poor percutaneous access options due to peripheral vascular disease.