Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study.

BACKGROUND: Subclinical leaflet thrombosis of bioprosthetic aortic valves after transcatheter valve replacement (TAVR) and surgical aortic valve replacement (SAVR) has been found with CT imaging. The objective of this study was to report the prevalence of subclinical leaflet thrombosis in surgical and transcatheter aortic valves and the effect of novel oral anticoagulants (NOACs) on the subclinical leaflet thrombosis and subsequent valve haemodynamics and clinical outcomes on the basis of two registries of patients who had CT imaging done after TAVR or SAVR. METHODS: Patients enrolled between Dec 22, 2014, and Jan 18, 2017, in the RESOLVE registry, and between June 2, 2014, and Sept 28, 2016, in the SAVORY registry, had CT imaging done with a dedicated four-dimensional volume-rendered imaging protocol at varying intervals after TAVR and SAVR. We defined subclinical leaflet thrombosis as the presence of reduced leaflet motion, along with corresponding hypoattenuating lesions shown with CT. We collected data for baseline demographics, antithrombotic therapy, and clinical outcomes. We analysed all CT scans, echocardiograms, and neurological events in a masked fashion. FINDINGS: Of the 931 patients who had CT imaging done (657 [71%] in the RESOLVE registry and 274 [29%] in the SAVORY registry), 890 [96%] had interpretable CT scans (626 [70%] in the RESOLVE registry and 264 [30%] in the SAVORY registry). 106 (12%) of 890 patients had subclinical leaflet thrombosis, including five (4%) of 138 with thrombosis of surgical valves versus 101 (13%) of 752 with thrombosis of transcatheter valves (p=0·001). The median time from aortic valve replacement to CT for the entire cohort was 83 days (IQR 33-281). Subclinical leaflet thrombosis was less frequent among patients receiving anticoagulants (eight [4%] of 224) than among those receiving dual antiplatelet therapy (31 [15%] of 208; p<0·0001); NOACs were equally as effective as warfarin (three [3%] of 107 vs five [4%] of 117; p=0·72). Subclinical leaflet thrombosis resolved in 36 (100%) of 36 patients (warfarin 24 [67%]; NOACs 12 [33%]) receiving anticoagulants, whereas it persisted in 20 (91%) of 22 patients not receiving anticoagulants (p<0·0001). A greater proportion of patients with subclinical leaflet thrombosis had aortic valve gradients of more than 20 mm Hg and increases in aortic valve gradients of more than 10 mm Hg (12 [14%] of 88) than did those with normal leaflet motion (seven [1%] of 632; p<0·0001). Although stroke rates were not different between those with (4·12 strokes per 100 person-years) or without (1·92 strokes per 100 person-years) reduced leaflet motion (p=0·10), subclinical leaflet thrombosis was associated with increased rates of transient ischaemic attacks (TIAs; 4·18 TIAs per 100 person-years vs 0·60 TIAs per 100 person-years; p=0·0005) and all strokes or TIAs (7·85 vs 2·36 per 100 person-years; p=0·001). INTERPRETATION: Subclinical leaflet thrombosis occurred frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. Anticoagulation (both NOACs and warfarin), but not dual antiplatelet therapy, was effective in prevention or treatment of subclinical leaflet thrombosis. Subclinical leaflet thrombosis was associated with increased rates of TIAs and strokes or TIAs. Despite excellent outcomes after TAVR with the new-generation valves, prevention and treatment of subclinical leaflet thrombosis might offer a potential opportunity for further improvement in valve haemodynamics and clinical outcomes. FUNDING: RESOLVE (Cedars-Sinai Heart Institute) and SAVORY (Rigshospitalet).

Concomitant mitral annular calcification and severe aortic stenosis: prevalence, characteristics and outcome following transcatheter aortic valve replacement.

AIMS: Calcified aortic stenosis (AS) and mitral annular calcification (MAC) have certain similar etiology and pathophysiological mechanisms. MAC is frequently encountered in pre-procedural computed tomography (CT) imaging of patients that undergo transcatheter aortic valve replacement (TAVR), but its prognostic implications for these patients have not been thoroughly investigated. This study sought to evaluate the prevalence of MAC among patients with severe AS and to assess the clinical implications of MAC on these patients during and following TAVR. METHODS AND RESULTS: Consecutive patients that underwent TAVR were compared according to the existence of MAC and its severity in pre-TAVR CT scans. From the entire cohort of 761 patients, 49.3% had MAC, and 50.7% did not have MAC. Mild MAC was present in 231 patients (30.4%), moderate MAC in 72 patients (9.5%), and severe MAC in 72 patients (9.5%). Thirty-day mortality and major complications were similar between patients with and without MAC. In a multivariable survival analysis, severe MAC was found to be an independent strong predictor of overall mortality following TAVR (all-cause mortality: hazards ratio [HR] 1.95, 95% confidence interval [CI] 1.24-3.07, P = 0.004; cardiovascular mortality: HR 2.35, 95% CI 1.19-4.66; P = 0.01). Severe MAC was also found to be an independent strong predictor of new permanent pacemaker implantation (PPI) after TAVR (OR 2.83, 95% CI 1.08-7.47; P = 0.03). CONCLUSION: Half of the patients with severe AS evaluated for TAVR were found to have MAC. Severe MAC is associated with increased all-cause and cardiovascular mortality and with conduction abnormalities following TAVR and should be included in future risk stratification models for TAVR.

Outcome of paravalvular leak repair after transcatheter aortic valve replacement with a balloon-expandable prosthesis.

BACKGROUND: Significant paravalvular leak (PVL) occurs in up to 13% of patients after transcatheter aortic valve replacement (TAVR) with a balloon-expandable bioprosthesis. Transcatheter PVL repair has emerged as a less invasive alternative for this problem. OBJECTIVES: The aim of this study was to evaluate the safety, feasibility, and clinical outcomes of transcatheter PVL repair after TAVR with balloon-expandable valve. METHODS: We retrospectively identified 15 patients who underwent 16 PVL repair procedures after the TAVR at our center. Procedural characteristics, results, and clinical outcomes were analyzed. The association of PVL repairs with subsequent hospitalizations and mortality was assessed and compared to 57 patients who did not undergo repair for at least moderate PVL after TAVR. RESULTS: The PVL repair was successful in 13 (87%) patients, without significant procedure or device related complications. In patients with successful PVL repair, there was an improvement in symptom status, subsequent hospitalizations, and B-type natriuretic peptide levels. There was 1 (out of 13, 8%) death in the group of patients who successfully underwent PVL repair whereas 24 (out of 57, 42%) patients died during follow up in the group that did not undergo repair of their PVL. Similarly, there was significant reduction in the subsequent heart failure related hospitalization after the PVL repair, compared with the patients who did not undergo PVL repair (P = 0.03). CONCLUSION: Transcatheter repair of PVL after TAVR can be safely and effectively accomplished in carefully selected patients, and may lead to reduction in hospitalizations, improvement in symptoms, and long-term survival. © 2016 Wiley Periodicals, Inc.

Transcatheter Aortic Valve Replacement With Different Valve Types in Elliptic Aortic Annuli.

BACKGROUND: The aim of this study was to determine the influence of an elliptic annulus on acute device success rates following self-expanding (SE) transcatheter aortic valve replacement (TAVR) vs. balloon-expandable (BE) TAVR.Methods and Results:Outcomes were assessed using Valve Academic Research Consortium-2 definitions. Aortic annulus ratio (AAR) was measured as short axis diameter/long axis diameter. Mean AAR was 0.81±0.06. Patients were therefore divided into 2 groups: AAR <0.82 and AAR ≥0.82. For circular annuli (AAR ≥0.82; 363 patients), high device success rates were achieved in both valve groups (SE valve, 90.5% vs. BE valve, 95.0%, P=0.14). Conversely, for AAR <0.82 (374 patients), SE valves had lower device success rates than BE valves (82.5% vs. 95.3%, P=0.002). For elliptic annuli, SE-TAVR was an independent predictor of unsuccessful device implantation (OR, 6.34, P<0.001). Nonetheless, increased oversizing of SE valves for elliptic annuli was associated with an exponential rise in device success (threshold ≥17.5%; area under the curve, 0.83) but not for BE-TAVR. Furthermore, optimally oversized SE valves and BE valves had a similarly high device success for elliptic annuli (SE valve, 96.2% vs. BE valve, 95.3%). CONCLUSIONS: For circular annuli, similarly high device success was achieved for the 2 valve types. Conversely, for elliptic annuli, SE valves had a lower device success than BE valves. Device success following optimal oversizing of SE valves, however, was similar to that for BE valves.

Transcatheter Aortic Valve Implantation With Different Valve Designs for Severe Device Landing Zone Calcification.

Severe device landing zone calcification (DLZ-CA) predicted paravalvular leak (PVL) and post-dilatation (PD) after transcatheter aortic valve implantation (TAVI). The aim of this study was to determine the influence of DLZ-CA on PVL or PD rates after SAPIEN XT (XT) versus CoreValve (CV).We analyzed patients undergoing TAVI who had severe DLZ-CA. Severe DLZ-CA defined the upper left ventricular outflow tract calcification; the cross-sectional region 2 mm inferior to the annular plane. PVL was evaluated at 30days using transthoracic echocardiography. Overall, 133 patients had XT-TAVI and the remaining 41 patients had CV-TAVI. Two patients had annulus injury in the XT group (oversizing 20.2% and 20.5% for two XT cases). PD was less frequently performed in the XT group (34.1% versus 12.8%; P = 0.002), but PVL rates were similar between both groups (42.1% versus 41.5% for the XT and CV groups, respectively; P = 0.94). Importantly, excessive oversizing or the degree of filling volume was not associated with decreased PVL after XT-TAVI (P = non-significant for all). On multivariate analysis, CV-TAVI was found to be one of the independent predictors of need for PD (Odds ratio 3.63, 95% confidence interval 1.55 to 8.53, P = 0.003).In the setting of severe DLZ-CA, XT and CV have similar rates of PVL but XT had less need for PD. Excessive oversizing with XT carries a risk of root injury which could be further increased by DLZ-CA.

Impact of body mass index on the outcomes following transcatheter aortic valve implantation.

OBJECTIVES: To investigate the influence of body mass index (BMI) on short- and midterm outcomes following transcatheter aortic valve implantation (TAVI). BACKGROUND: Although obesity is a major risk factor for cardiovascular mortality, numerous studies reported a beneficial effect of obesity on survival in patients with cardiovascular disease and in patients after cardiac interventions. Moreover, all previous reports examining the relation between BMI and outcomes following TAVI have underscored the "obesity paradox" in these patients. METHODS: During a 3 year period, 805 patients with severe aortic stenosis that underwent TAVI at our institute were evaluated. Based on baseline BMI, patients were classified as normal weight (18.5-24.9 kg/m(2) ), overweight (25.0-29.9 kg/m(2) ), or obese (≥30 kg/m(2) ). TAVI endpoints, device success, and adverse events were considered according to the Valve Academic Research Consortium (VARC)-2 definitions. RESULTS: Obese patients were significantly younger, had higher prevalence of diabetes mellitus and chronic lung disease, and had lower prevalence of frailty. Device success was similar between the 3 groups. All-cause mortality up to 30 days was 2.9% (10/340) vs 4.5% (12/268) vs 0.5% (1/186) in patients with normal weight, overweight, and obesity, respectively (p = 0.048). In a multivariable model, overweight and obese patients had similar overall mortality compared to patients with normal weight. CONCLUSIONS: We found no evidence for the existence of an obesity paradox following TAVI. Correction for possible confounders such as frailty in the present cohort may explain the discrepancy between the current report and the previous reports that suggested a protective effect for increased BMI following TAVI. © 2016 Wiley Periodicals, Inc.

Balloon-expandable transcatheter aortic valve replacement in patients with extreme aortic valve calcification.

OBJECTIVES: To assess the procedural and short-term clinical outcome of performing balloon-expandable TAVR in patients with extremely calcified aortic valves. BACKGROUND: Quantity of aortic valve calcification predicts rates of paravalvular regurgitation (PVR) post transcatheter aortic valve replacement (TAVR). Nonetheless, short-term outcomes of balloon-expandable TAVR in patients with extremely high calcified aortic valves have not been previously described. METHODS: We studied patients with severe aortic stenosis that underwent balloon-expandable TAVR and had a pre-procedural non-contrast CT. Twenty patients that had aortic valve calcification score (AVCS) of more than 8,000 Agatston Units were compared to 279 patients with lower calcification scores. TAVR endpoints, device success and adverse events were considered according to the Valve Academic Research Consortium-2 definitions. RESULTS: Device success was 80% in the extremely high calcification group compared to 95.3% in patients with less calcified aortic valves (P = 0.004). There was significantly more postprocedural PVR in the extreme calcification group: 50%, 35%, 10%, 5% vs. 72.4%, 25.8%, 1.8%, 0% for no/trace, mild, moderate and severe PVR, respectively (P < 0.001). There was one case of ascending aortic perforation resulting in intramural hematoma that resolved with no treatment. In-hospital mortality, new pacemaker implantation and major complications were similar between groups. CONCLUSIONS: Balloon-expandable TAVR in patients with extremely calcified aortic valve is associated with lower device success and greater risk of PVR. © 2015 Wiley Periodicals, Inc.

Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation.

BACKGROUND: The majority of transcatheter aortic valve implantation (TAVI) procedures are currently performed by percutaneous transfemoral approach. The potential contribution of the type of vascular closure device to the incidence of vascular complications is not clear. AIM: To compare the efficacy of a Prostar XL- vs. Perclose ProGlide-based vascular closure strategy. METHODS: The ClOsure device iN TRansfemoral aOrtic vaLve implantation (CONTROL) multi-center study included 3138 consecutive percutaneous transfemoral TAVI patients, categorized according to vascular closure strategy: Prostar XL- (Prostar group) vs. Perclose ProGlide-based vascular closure strategy (ProGlide group). Propensity-score matching was used to assemble a cohort of patients with similar baseline characteristics. RESULTS: Propensity matching identified 944 well-matched patients (472 patient pairs). Composite primary end point of major vascular complications or in-hospital mortality occurred more frequently in Prostar group when compared with ProGlide group (9.5 vs. 5.1%, P = 0.016), and was driven by higher rates of major vascular complication (7.4 vs. 1.9%, P < 0.001) in the Prostar group. However, in-hospital mortality was similar between groups (4.9 vs. 3.5%, P = 0.2). Femoral artery stenosis occurred less frequently in the Prostar group (3.4 vs. 0.5%, P = 0.004), but overall, Prostar use was associated with higher rates of major bleeding (16.7 vs. 3.2%, P < 0.001), acute kidney injury (17.6 vs. 4.4%, P < 0.001) and with longer hospital stay (median 6 vs. 5 days, P = 0.007). CONCLUSIONS: Prostar XL-based vascular closure in transfemoral TAVI procedures is associated with higher major vascular complication rates when compared with ProGlide; however, in-hospital mortality is similar with both devices.

Comparison of early and late outcomes of TAVI alone compared to TAVI plus PCI in aortic stenosis patients with and without coronary artery disease.

OBJECTIVES: To assess the safety and effectiveness of performing percutaneous coronary intervention (PCI) before transcatheter aortic valve implantation (TAVI). BACKGROUND: The presence of coronary artery disease (CAD) negatively impact procedural outcomes and long-term survival after (TAVI). The management of obstructive CAD before TAVI is not yet well established. METHODS: Patients with severe symptomatic aortic stenosis (AS) (n = 249) that underwent TAVI were divided into two groups: patients with CAD (subdivided to patients treated with TAVI alone and to patients that underwent PCI before TAVI) and patients with isolated AS. Procedural endpoints, device success and adverse events were considered according to the Valve Academic Research Consortium (VARC) definitions. RESULTS: Of a cohort of 249 consecutive patients with mean age of 83.2 ± 5.5 years, 83 patients with AS + CAD were treated with TAVI alone, 61 patients with AS + CAD underwent PCI before TAVI and 105 patients underwent TAVI for isolated AS. The mean duration of follow-up was 17 months (range: 6-36 months). Despite a significantly higher logistic EuroScore of the AS+CAD group compared to the AS alone group (30.1 vs. 21.1 P < 0. 001), the overall VARC-adjudicated endpoints did not differ between the groups. All-cause mortality at 30-days was 1.6% for patients with AS+CAD treated with PCI compared to 2.9% for patients with AS alone (P = 1). CONCLUSIONS: Performing PCI before TAVI in high-risk elderly patients with significant CAD and severe AS is feasible and safe. This combined treatment approach did not increase the periprocedural risk for complications or the all-cause mortality.

Prevalence and predictors of carotid artery stenosis in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.

OBJECTIVES: Our aim was to analyze the prevalence and predictors of Carotid artery stenosis (CAS) in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: CAS is associated with the risk of periprocedural stroke in patients undergoing cardiac surgery. However, little is known about the prevalence of and clinical significance of CAS in the setting of TAVI. METHODS: Consecutive patients undergoing a carotid Doppler study the day before TAVI were followed prospectively. CAS was defined in accordance with current practice guidelines. Logistic regression models were used to identify independent correlates of CAS. RESULTS: The study included 171 patients (age 82 ± 6, male gender 47%). Carotid atherosclerosis (CA, defined as any carotid plaque) was present in 164 (96%) of patients, and CAS (peak systolic velocity [PSV] ≥ 125 cm/sec; ≥50% diameter stenosis) in 57 (33%) patients. Severe CAS (PSV ≥ 230 cm/sec; ≥70% stenosis, or near occlusion) was found in 15 (9%) patients. By multivariate analysis, smoking and a higher Euroscore independently predicted the presence of CAS. Patients in the present TAVI cohort had a significantly higher prevalence of both unilateral and bilateral CAS ≥ 50% than those in a previously reported cohort (n = 494 patients, age ≥ 70) undergoing clinically driven coronary angiography (33% vs. 20%, OR = 1.9, P = 0.001; and, 13% vs. 6%, OR = 2.3, P = 0.003, respectively). CAS was not independently associated with 30-day mortality or stroke rates. CONCLUSIONS: The prevalence of CAS in patients undergoing TAVI is high, exceeding that observed in patients undergoing catheterization for coronary indications. The impact of CAS on clinical outcomes following TAVI merits further research.

Radiation dose of patients undergoing transcatheter aortic valve implantation: a comparison between Edwards SAPIEN XT and Medtronic CoreValve aortic valve prostheses.

BACKGROUND: The relative radiation dose (RD) of patients undergoing transcatheter aortic valve implantation (TAVI) with either the Edwards Sapien XT (ESX) or the Medtronic CoreValve (MCV) prostheses has not been studied in depth. Our aim was to quantify RD in uncomplicated transfemoral TAVI with either prosthesis. METHODS: We analyzed 248 consecutive patients undergoing uncomplicated transfemoral TAVI between March 2009 and September 2012, at a single tertiary care facility. Total air Kerma, cumulated dose area product (DAP), and fluoroscopy time were determined in each case. RESULTS: The ESX and MCV prostheses were implanted in 44 and 204 patients, respectively. Though mean fluoroscopy time was higher during ESX valve implantation, overall RD per total air Kerma and DAP was significantly higher during MCV implantation (P < 0.05 for both comparisons). By multivariate regression analyses, prosthesis type was an independent predictor of RD according to both total air Kerma and DAP (r(2) = 0. 498; P < 0.01 and r(2) = 0.363; P < 0.01, respectively). CONCLUSION: In uncomplicated transfemoral TAVI, RD is greater during MCV implantation than during ESX implantation.

Transcatheter aortic valve implantation: a single-center experience of 300 cases.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has recently become an alternative to surgical aortic valve replacement in selected patients with high operative risk. OBJECTIVES: To investigate the 30 day clinical outcome of the first 300 consecutive patients treated with transfemoral TAVI at the Tel Aviv Medical Center. METHODS: The CoreValve was used in 250 patients and the Edwards-Sapien valve in 50. The mean age of the patients was 83 +/- 5.3 years (range 63-98 years) and the mean valve area 0.69 +/- 0.18 cm2 (range 0.3-0.9 cm2); 62% were women. RESULTS: The procedural success rate was 100%, and 30 day follow-up was done in all the patients. The average Euro-score for the cohort was 26 +/- 13 (range 1.5-67). Total in-hospital mortality and 30 day mortality were both 2.3% (7 patients). Sixty-seven patients (22%) underwent permanent pacemaker implantation after the TAVI procedure, mostly due to new onset of left bundle brunch block and prolonged PR interval or to high degree atrioventricular block. The rate of stroke was 1.7% (5 patients). Forty-one patients (13.7%) had vascular complications, of whom 9 (3%) were defined as major vascular complications (according to the VARC definition). CONCLUSIONS: The 30 day clinical outcome in the first 300 consecutive TAVI patients in our center was favorable, with a mortality rate of 2.3% and low rates of stroke (1.7%) and major vascular complications (3%).

Nonobstructive coronary atherosclerosis is associated with adverse prognosis among patients diagnosed with myocardial infarction without obstructive coronary arteries.

BACKGROUND AND AIMS: The prognostic impact of nonobstructive coronary artery disease (CAD), as opposed to normal coronary arteries, on long-term outcomes of patients with myocardial infarction with no obstructive coronary arteries (MINOCA) is unclear. We aimed to address the association between nonobstructive-CAD and major adverse events (MAE) following MINOCA. METHODS: We conducted a retrospective cohort study of consecutive MINOCA patients admitted to a large referral medical center between 2005 and 2018. Patients were classified according to coronary angiography as having either normal-coronaries or nonobstructive-CAD. The primary outcome was MAE, defined as the composite of all-cause mortality and recurrent acute coronary syndrome (ACS). RESULTS: Of the 1544 MINOCA patients, 651 (42%) had normal coronaries, and 893 (58%) had CAD. The mean age was 61.2 ± 12.6 years, and 710 (46%) were females. Nonobstructive-CAD patients were older and less likely to be females, with higher rates of diabetes, hypertension, dyslipidemia, atrial fibrillation, and chronic renal-failure (p < 0.05). At a median follow-up of 7 years, MAE occurred in 203 (23%) patients and 67 (10%) patients in the nonobstructive-CAD and normal-coronaries groups, respectively (p < 0.01). In multivariable models, nonobstructive -CAD was significantly associated with long-term MAE [adjusted-hazard-ratio (aHR):1.67, 95% confidence-interval (95%CI):1.25-2.23; p < 0.001]. Other factors associated with a higher MAE-risk were older-age (aHR:1.05,95%CI:1.03-1.06; p < 0.001) and left ventricular ejection-fraction<40% (aHR:3.04,95%CI:2.03-4.57; p < 0.001), while female-sex (aHR:0.72, 95%CI: 0.56-0.94; p=0.014) and sinus rhythm at presentation (aHR:0.66, 95%CI: 0.44-0.98; p=0.041) were associated with lower MAE-risk. CONCLUSIONS: In MINOCA, nonobstructive-CAD is independently associated with a higher MAE-risk than normal-coronaries. This finding may promote risk-stratification of patients with nonobstructive-CAD-MINOCA who require tighter medical follow-up and treatment optimization.

Predictors of Adverse Outcome in High-Risk Percutaneous Coronary Interventions Patients.

BACKGROUND: Identifying high-risk percutaneous coronary intervention (PCI) patients is challenging. We aimed to evaluate which high-risk patients are prone to adverse events. METHODS: We performed a retrospective study including consecutive high-risk PCIs from 2005 to 2018 in a large tertiary medical centre. Patients with unprotected left main (LM) disease, last patent coronary vessel, or 3-vessel coronary artery disease with left ventricular ejection fraction < 35% were included. A predictive 30-day major adverse cardiac events (MACE) score consisting of any myocardial infarction, all-cause death, or target-vessel revascularisation was constructed. RESULTS: From 2005 to 2018, a total of 1890 patients who underwent PCI met the predefined high-risk PCI criteria. Mortality rate was 8.8% at 30 days and 20.7% at 1 year, and 30-day MACE rate was 14.2% and 33.5% at 1 year. Predictors of short-term MACE were New York Heart Association functional class (NYHA) 4 (hazard ratio [HR] 6.65; P < 0.001), systolic blood pressure (SBP) < 90 mm Hg (HR 4.93; P < 0.001), creatinine > 1.3 mg/dL (HR 3.57; P < 0.001), hemoglobin < 11.0 g/dL (HR 3.07; P < 0.001), pulmonary artery systolic pressure > 50 mm Hg (HR 2.06; P < 0.001), atrial fibrillation (HR 1.74; P < 0.001), and LM disease (HR 2.04; P < 0.001) or last patent vessel (HR 1.70; P = 0.002). A score constructed from these parameters reached a sensitivity of 90% and a specificity of 81% with areas under the receiver operating characteristic curve of 0.92 for MACE and 0.94 with 89% sensitivity and 87% specificity for all-cause mortality. CONCLUSIONS: Specific features such as LM lesion or last patent conduit, pulmonary hypertension, atrial fibrillation, anemia, and renal failure, along with low SBP and NYHA 4, aid risk stratification and consideration of further treatment measures.

Development of saliva-based cardiac troponin I point-of-care test using alpha-amylase depletion: a feasibility study.

INTRODUCTION: Cardiac troponin (cTn) is the biomarker of choice for detection of myocardial injury. There is a great need for simple point-of-care (POC) troponin testing among patients with chest pain, mainly in the prehospital setting. The purpose of this study was to evaluate the presence of cardiac troponin I (cTnI) in saliva of patients with myocardial injury using alpha-amylase depletion technique. METHODS: Saliva samples were collected from 40 patients with myocardial injury who were tested positive for conventional high-sensitivity cardiac troponin T (cTnT) blood tests, and from 66 healthy volunteers. Saliva samples were treated for the removal of salivary alpha-amylase. Treated and untreated samples were tested with blood cTnI Rapid Diagnostic Test. Salivary cTnI levels were compared to blood cTnT levels. RESULTS: Thirty-six of 40 patients with positive blood cTnT had positive salivary samples for cTnI following alpha-amylase depletion treatment (90.00% sensitivity). Moreover, three of the four negative saliva samples were obtained from patients with relatively low blood cTnT levels of 100 ng/L or less (96.88% sensitivity for 100 ng/L and above). The negative predictive value was 93.65% and rose up to 98.33% considering the 100 ng/L cutoff. Positive predictive values were 83.72% and 81.58%, respectively. Among 66 healthy volunteers and 7 samples yielded positive results (89.39% specificity). CONCLUSION: In this preliminary work, the presence of cTnI in saliva was demonstrated for the first time to be feasibly identified by a POC oriented assay. The specific salivary alpha-amylase depletion technique was shown to be crucial for the suggested assay.

The impact of lockdown enforcement during the SARSCoV-2 pandemic on the timing of presentation and early outcomes of patients with ST-elevation myocardial infarction.

INTRODUCTION: Early reports described decreased admissions for acute cardiovascular events during the SarsCoV-2 pandemic. We aimed to explore whether the lockdown enforced during the SARSCoV-2 pandemic in Israel impacted the characteristics of presentation, reperfusion times, and early outcomes of ST-elevation myocardial infarction (STEMI) patients. METHODS: A multicenter prospective cohort comprising all STEMI patients treated by primary percutaneous coronary intervention admitted to four high-volume cardiac centers in Israel during lockdown (20/3/2020-30/4/2020). STEMI patients treated during the same period in 2019 served as controls. RESULTS: The study comprised 243 patients, 107 during the lockdown period of 2020 and 136 during the same period in 2019, with no difference in demographics and clinical characteristics. Patients admitted in 2020 had higher admission and peak troponin levels, had a 2.4 fold greater likelihood of Door-to-balloon times> 90 min (95%CI: 1.2-4.9, p = 0.01) and 3.3 fold greater likelihood of pain-to-balloon times> 12 hours (OR 3.3, 95%CI: 1.3-8.1, p<0.01). They experienced higher rates hemodynamic instability (25.2% vs 14.7%, p = 0.04), longer hospital stay (median, IQR [4, 3-6 Vs 5, 4-6, p = 0.03]), and fewer early (<72 hours) discharge (12.4% Vs 32.4%, p<0.001). CONCLUSIONS: The lockdown imposed during the SARSCoV-2 pandemic was associated with a significant lag in the time to reperfusion of STEMI patients. Measures to improves this metric should be implemented during future lockdowns.

Investigation of Computed-Tomography Based Predictors of Acute Stroke Related to Transcatheter Aortic Valve Replacement: Aortic Wall Plaque Thickness Might be a Predictive Parameter of Stroke.

OBJECTIVES: Little information is available on computed tomography (CT)-based predictors of stroke related to transcatheter aortic valve replacement (TAVR). The objective of this study was to determine whether anatomical features of the aortic valve and aorta visualized by CT are predictive parameters of stroke. METHODS: The study included 1270 patients who underwent preprocedural contrast-enhanced CT assessment and TAVR for severe aortic valve stenosis. Twenty-six patients (2.5%) who developed acute strokes that occurred within 48 hours after TAVR and 104 matched patients without strokes were identified, using 1:4 propensity-score matching. The degree of hypoattenuation in the aortic valve leaflets, calcium volume of the aortic valve, and plaque thickness in the aortic wall (the ascending aorta, aortic arch, and descending thoracic aorta) were assessed. RESULTS: There were no differences between the two groups in the degree of hypoattenuation in the aortic valve leaflets and calcium volume of the aortic valve. The plaque thickness of the aortic arch and descending aorta were greater in the stroke group than in the non-stroke group: aortic arch, 2.4 mm (IQR, 1.3-2.8 mm) vs 1.8 mm (IQR, 1.4-2.2 mm), respectively (P<.01); and descending aorta, 2.9 mm (IQR, 2.1-4.2 mm) vs 2.8 mm (IQR, 2.1-3.6 mm); respectively (P=.049). CONCLUSION: Aortic wall plaque thickness measured by contrast-enhanced CT might be a predictive parameter of strokes that occur within 48 hours after TAVR.

Pleural effusion: characterization with CT attenuation values and CT appearance.

OBJECTIVE: The purpose of this study was to assess the utility of CT in characterizing pleural effusions on the basis of attenuation values and CT appearance. MATERIALS AND METHODS: We retrospectively analyzed 100 pleural effusions in patients who underwent chest CT and diagnostic thoracentesis within 48 hours of each other. On the basis of Light's criteria, effusions were classified as exudates or transudates using laboratory biochemistry markers. The mean value in Hounsfield units of an effusion was determined using a region of interest on the three slices with the greatest quantity of fluid. All CT scans also were reviewed for the presence of additional pleural features such as fluid loculation, pleural thickening, and pleural nodules. RESULTS: Twenty-two of the 100 pleural effusions were transudates and 78 were exudates. The mean attenuation of the exudates (7.2 HU; [SD] 9.4 HU; range, 21-28 HU) was not significantly lower than the mean attenuation of the transudates (10.1 HU; 6.9 HU; range, 0.3-32 HU), (p = 0.24). None of the additional CT features accurately differentiated exudates from transudates (p > 0.1). Fluid loculation was found in 58% of exudates and in 36% of transudates. Pleural thickening was found in 59% of exudates and in 36% of transudates. CONCLUSION: The clinical use of CT attenuation values to characterize pleural fluid is not accurate. Although fluid loculation, pleural thickness, and pleural nodules were more commonly found in patients with exudative effusions, the presence of these features does not accurately differentiate between exudates and transudates.

Prognostic Impact of Permanent Pacemaker Implantation in Patients With Low Left Ventricular Ejection Fraction Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Data are limited regarding the clinical impact of permanent pacemaker implantation (PPI) in patients with low left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR). The aim of this study was to determine the impact of new PPI in patients with baseline low LVEF at 2-year follow-up after TAVR. METHODS: A total of 659 patients undergoing TAVR between January 2013 and December 2015 were included in the study. Patients were divided into two groups according to the need for PPI after TAVR. These patients were further divided by their baseline LVEF: low LVEF (≤50%) and preserved LVEF (>50%). RESULTS: A total of 104 patients (15.8%) needed PPI following TAVR. After a median follow-up of 19.1 months (interquartile range, 11.4-24.4 months), overall and cardiovascular survival showed no significant differences between new PPI and no PPI (overall, log-rank P=.94; cardiovascular, log-rank P=.51). Nonetheless, patients requiring PPI who had low LVEF had higher cardiovascular mortality compared to patients with low LVEF who didn't need PPI (log-rank P<.001). Multivariable Cox hazard model demonstrated that patients with new PPI and low LVEF had higher 2-year cardiovascular mortality after TAVR (hazard ratio, 5.76; P<.001). CONCLUSION: New PPI following TAVR was not associated with overall survival or cardiovascular survival difference at 2 years. However, receiving a new PPI in the setting of low LVEF adversely impacts mid-term cardiovascular survival.