P2Y12 adenosine receptor inhibitors preloading among patients with non-ST-elevation acute coronary syndromes; insights from a nationwide multicenter registry.

BACKGROUND: The safety and efficacy of treatment with P2Y12 adenosine-diphosphate receptor inhibitors (P2Y12-RI) before coronary angiography among patients with non-ST-segment elevation acute coronary syndromes (NSTEACS) are questionable. AIMS: To assess the pretreatment rate with P2Y12-RI and its association with ischemic and bleeding risks among patients with NSTEACS. METHODS: The study comprised patients with NSTEACS referred for coronary angiography and included in the Acute Coronary Syndrome Israeli Surveys between 2013 and 2021. Patients were divided into two groups according to the timing of P2Y12-RI loading concerning coronary angiography: pretreatment and posttreatment. The primary endpoints were 30-day major adverse cardiovascular events (MACE; composite of cardiovascular mortality, myocardial infarction, stroke, stent thrombosis, and urgent revascularization) and 1-year all-cause mortality. RESULTS: Of 3076 patients, 2423 (78.8%) received pretreatment with a P2Y12-RI, and 653 (21.2%) received P2Y12-RI posttreatment. Prasugrel and ticagrelor were used more in the posttreatment group compared to the pretreatment group (16% vs. 6% and 38% vs. 25%, respectively, p < 0.001 for both). No difference was observed in the rate of 30-day MACE comparing pretreatment and posttreatment (5.3% vs. 2.2%, respectively, p = 0.62). A sensitivity analysis of 30-day MACE among patients from the 2021 survey demonstrated similar results (2.5% in the posttreatment group vs. 8.0% in the pretreatment group, p = 0.13). There were no differences in 1-year all-cause mortality rates between the pretreatment and posttreatment groups (4.8% vs. 3.8%, p = 0.31). CONCLUSIONS: Among patients with NSTEACS referred for an invasive strategy, the P2Y12-RI posttreatment strategy was associated with similar 30-day and 1-year MACE as the pretreatment strategy. These large-scale, multicenter, real-world data provide reassurance on the safety and efficacy of delaying P2Y12-IR until after coronary stratification to improve clinical decision-making.

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.

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.

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.

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.

Retrieval of a Very Large Foreign Body From the Bronchial Tree in an Intubated Patient / Recuperación de un cuerpo extraño de gran tamaño del árbol bronquial de un paciente intubado

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Anticoagulation After Surgical or Transcatheter Bioprosthetic Aortic Valve Replacement.

BACKGROUND: There is paucity of evidence on the impact of anticoagulation (AC) after bioprosthetic aortic valve replacement (AVR) on valve hemodynamics and clinical outcomes. OBJECTIVES: The study aimed to assess the impact of AC after bioprosthetic AVR on valve hemodynamics and clinical outcomes. METHODS: Data on antiplatelet and antithrombotic therapy were collected. Echocardiograms were performed at 30 days and 1 year post-AVR. Linear regression model and propensity-score adjusted cox proportional model were used to assess the impact of AC on valve hemodynamics and clinical outcomes, respectively. RESULTS: A total of 4,832 patients undergoing bioprosthetic AVR (transcatheter aortic valve replacement [TAVR], n = 3,889 and surgical AVR [SAVR], n = 943) in the pooled cohort of PARTNER2 (Placement of Aortic Transcatheter Valves) randomized trials and nonrandomized registries were studied. Following adjustment for valve size, annular diameter, atrial fibrillation, and ejection fraction at the time of assessment of hemodynamics, there was no significant difference in aortic valve mean gradients or aortic valve areas between patients discharged on AC vs. those not discharged on AC, for either TAVR or SAVR cohorts. A significantly greater proportion of patients not discharged on AC had an increase in mean gradient >10 mm Hg from 30 days to 1 year, compared with those discharged on AC (2.3% vs. 1.1%, p = 0.03). There was no independent association between AC after TAVR and adverse outcomes (death, p = 0.15; rehospitalization, p = 0.16), whereas AC after SAVR was associated with significantly fewer strokes (hazard ratio [HR]: 0.17; 95% confidence interval [CI]: 0.05-0.60; p = 0.006). CONCLUSIONS: In the short term, early AC after bioprosthetic AVR did not result in adverse clinical events, did not significantly affect aortic valve hemodynamics (aortic valve gradients or area), and was associated with decreased rates of stroke after SAVR (but not after TAVR). Whether early AC after bioprosthetic AVR has impact on long-term outcomes remains to be determined. (Placement of AoRTic TraNscathetER Valves [PARTNERII A]; NCT01314313).

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.

Early Clinical Outcomes of Transcatheter Aortic Valve Replacement in Left Ventricular Outflow Tract Calcification: New-Generation Device vs Early-Generation Device.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in cases with left ventricular outflow tract calcification (LVOT-CA) remains a challenging procedure. The aim of this study was to compare the early outcomes of patients undergoing TAVR in LVOT-CA with new-generation devices vs early-generation devices. METHODS: Between January 2014 and December 2016, a total of 433 patients with severe aortic stenosis who had a preprocedural multidetector computed tomography underwent TAVR in a LVOT-CA. After propensity matching, data from 119 patients in each group were analyzed. TAVR endpoints and adverse events were defined according to the Valve Academic Research Consortium-2. RESULTS: Compared with early-generation devices (Edwards Sapien/Sapien XT/CoreValve), new-generation devices (Sapien 3/Evolut R) had significantly lower incidence of mild-moderate paravalvular leak (PVL) (1.7% new vs 7.6% early; P=.03), tended to have lower incidence of moderate or severe PVL (5.0% new vs 11.8% early; P=.06), had no significant difference in device success (89.1% new vs 83.2% early; P=.19), and had a significantly higher early safety rate at 30 days (93.3% new vs 84.9% early; P=.04). For cardiac conduction disturbances, new-generation and early-generation devices had similarly high rates of new permanent pacemaker implantation (16.8% new vs 15.1% early; P=.72), whereas the number of patients who developed new-onset left bundle-branch block (LBBB) were significantly higher in those with new-generation devices (16.0% new vs 6.7% early; P=.03). CONCLUSION: In the setting of LVOT-CA, patients with new-generation devices compared to those with early-generation devices had acceptable clinical outcomes except for cardiac conduction disturbances, especially in new-onset LBBB.

Impact of Aortic Root Anatomy and Geometry on Paravalvular Leak in Transcatheter Aortic Valve Replacement With Extremely Large Annuli Using the Edwards SAPIEN 3 Valve.

OBJECTIVES: The aim of this study was to determine factors affecting paravalvular leak (PVL) in transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. BACKGROUND: The largest recommended annular area for the 29-mm S3 is 683 mm2. However, experience with S3 TAVR in annuli >683 mm2 has not been widely reported. METHODS: From December 2013 to July 2017, 74 patients across 16 centers with mean area 721 ± 38 mm2 (range: 684 to 852 mm2) underwent S3 TAVR. The transfemoral approach was used in 95%, and 39% were under conscious sedation. Patient, anatomic, and procedural characteristics were retrospectively analyzed. Valve Academic Research Consortium-2 outcomes were reported. RESULTS: Procedural success was 100%, with 2 deaths, 1 stroke, and 2 major vascular complications at 30 days. Post-dilatation occurred in 32%, with final balloon overfilling (1 to 5 ml extra) in 70% of patients. Implantation depth averaged 22.3 ± 12.4% at the noncoronary cusp and 20.7 ± 9.9% at the left coronary cusp. New left bundle branch block occurred in 17%, and 6.3% required new permanent pacemakers. Thirty-day echocardiography showed mild PVL in 22.3%, 6.9% moderate, and none severe. There was no annular rupture or coronary obstruction. Mild or greater PVL was associated with larger maximum annular and left ventricular outflow tract (LVOT) diameters, larger LVOT area and perimeter, LVOT area greater than annular area, and higher annular eccentricity. CONCLUSIONS: TAVR with the 29-mm S3 valve beyond the recommended range by overexpansion is safe, with acceptable PVL and pacemaker rates. Larger LVOTs and more eccentric annuli were associated with more PVL. Longer term follow-up will be needed to determine durability of S3 TAVR in this population.

High-pressure post-dilation following transcatheter valve-in-valve implantation in small surgical valves.

AIMS: Residual gradients >20 mmHg after transcatheter valve-in-valve (ViV) implantation are associated with worse survival. This study aimed to evaluate the feasibility of high-pressure post-dilation with a non-compliant balloon after transcatheter ViV implantation in small surgical valves to optimise haemodynamics. METHODS AND RESULTS: Thirty patients underwent ViV implantation in surgical valves with internal dimension ≤19 mm. High-pressure post-dilation to 16-20 atmospheres with a non-compliant balloon was performed in 12 patients and 18 patients underwent ViV without post-dilation. SAPIEN 3 and Evolut valves were used in 10 and two patients, respectively. The mean aortic valve (AV) gradient decreased by 11.3 mmHg following high-pressure post-dilation (18.7±7.9 mmHg immediately post ViV to 7.5±2.6 mmHg following high-pressure post-dilation, p<0.01). There were no cases of aortic root rupture. High-pressure post-dilation, compared to no post-dilation, was associated with lower invasive AV mean gradients at the end of the ViV procedure (8.2±3.5 mmHg vs. 17.3±7.9 mmHg, p=0.001) as well as lower day 1 (18.0±4.5 mmHg vs. 25.0±8.1 mmHg, p=0.016) and 30-day gradients (19.8±2.5 vs. 26.5±11.0, p=0.038) on transthoracic echocardiography. CONCLUSIONS: High-pressure post-dilation of small surgical valves following transcatheter ViV implantation results in a significant improvement in post-procedure haemodynamics.