Comparison of different transbronchial biopsy sampling techniques for the diagnosis of peripheral pulmonary lesions with radial endobronchial ultrasound-guided bronchoscopy: A prospective study

BackgroundData regarding the transbronchial biopsy (TBB) techniques in radial endobronchial ultrasound (R-EBUS)-guided bronchoscopy are limited. The purpose of this study was to compare three R-EBUS-guided TBB techniques for the diagnosis of peripheral pulmonary lesions (PPLs).MethodsA prospective pilot study was conducted including 90 patients with positive bronchus sign PPLs, who underwent R-EBUS-guided TBB. TBB techniques were performed in all patients using small biopsy forceps with a guide sheath (GS). These samples were submitted for both cell block histology (CB) and conventional histology (SB). Standard biopsy forceps were used to collect further samples that were submitted for conventional histology (LB). The diagnostic yields of the three techniques were compared.ResultsThe mean diameter of the PPLs was 25.5 ± 8.2 mm and the final diagnoses included 70 malignant and 20 benign lesions. The overall diagnostic yield of R-EBUS-guided bronchoscopy was 82.2%. Although the difference was not statistically significant, CB provided the highest yield of the three TBB techniques: 68.9%, 65.6%, and 62.2% for CB, SB, and LB, respectively (P = 0.20). When the GS was removed and standard biopsy forceps were introduced, misplacement (detected by fluoroscopy) was observed in 24 cases, and LB provided a diagnosis in 11 cases. PPLs ≤20 mm were associated with misplacement (P = 0.003). After the exclusion of misplaced cases, the diagnostic yields were 69.7%, 71.2%, and 68.2% for CB, SB, and LB, respectively (P = 0.65).ConclusionsNeither the size of biopsy forceps nor the histology process affected the diagnostic yield of R-EBUS-guided bronchoscopy.     

Sedation with fentanyl and midazolam without oropharyngeal anesthesia compared with sedation with pethidine and midazolam with oropharyngeal anesthesia in ultrathin bronchoscopy for peripheral lung lesions

BackgroundIn advanced lung cancer, precision medicine requires repeated biopsies via bronchoscopy at therapy change. Since bronchoscopies are often stressful for patients, sedation using both fentanyl and midazolam is recommended in Europe and America. In Japan, bronchoscopies are generally orally performed under midazolam and oropharyngeal anesthesia. Nasal intubation creates a physiological route to the trachea, causing less irritation to the pharynx than intubation via the oral cavity; however, the necessity of oropharyngeal anesthesia remains unclear. We aimed to compare the safety, patient discomfort, and diagnostic rates for oropharyngeal anesthesia and sedation with pethidine and midazolam (Group A) and sedation with midazolam and fentanyl without oropharyngeal anesthesia (Group B) for ultrathin bronchoscopy of peripheral pulmonary lesions (PPLs) via nasal intubation.MethodsWe retrospectively reviewed 74 consecutive potential lung cancer patients who underwent ultrathin bronchoscopies at the Hakodate Goryoukaku Hospital between July 2019 and June 2020. We reviewed the following: diagnostic rates; cumulative doses of lidocaine, midazolam, and fentanyl; hemodynamic changes; procedural complications in both groups. Pharyngeal anesthesia in group A was administered by spraying 2% (w/v) lidocaine into the pharynx. The chi-squared test was used for statistical analyses.ResultsThere were no significant changes in hemodynamic parameters and complications. The mean level of discomfort for bronchoscopic examinations was significantly lower in Group B (2.39 vs. 1.64; P = 0.014), with no significant inter-group difference in the diagnostic yields for PPLs (63.0% vs. 71.4%; P = 0.46).ConclusionsOur findings indicate the advantages of sedation with fentanyl and midazolam without oropharyngeal anesthesia for ultrathin bronchoscopy through nasal intubation.     

Topical nasal xylometazoline for flexible bronchoscopy (VAIN): A randomized,double-blind,placebo-controlled trial

BackgroundThe role of topical nasal vasoconstrictor administration during flexible bronchoscopy is unclear.MethodsConsecutive subjects undergoing flexible bronchoscopy were randomized to receive either topical xylometazoline (0.1%) or placebo (saline nasal spray, 0.74% w/v isotonic solution) before bronchoscopy. Background topical anesthesia included 2% nasal lignocaine gel, pharyngeal spray of 10% lignocaine, and 1% lignocaine solution for spray-as-you-go administration. The primary outcome was the operator rated ease of nasal negotiation of the bronchoscope on the visual analog scale (Negotiation VAS). Secondary objectives included assistant rated facial pain scale score, patient-rated nasal pain score (Pain VAS), time to reach the vocal cords after bronchoscope insertion, operator rated nasal mucosal trauma score (Trauma VAS), hemodynamic changes, and complications between the groups.ResultsIn all, 148 subjects were recruited and randomized to the placebo (73) and xylometazoline groups (75). Operator rated ease of nasal bronchoscope negotiation (Negotiation VAS) was similar in both the groups [Median (IQR), 1 (1–2) in both groups, p = 0.79]. There were no differences in the other outcomes including assistant rated score of facial pain [(Median (IQR), 2 (2–4) placebo and 2 (2–4) xylometazoline, p = 0.36], Pain VAS [Median (IQR), placebo 2 (1–2) and xylometazoline 2 (1–3), p = 0.28], Trauma VAS, [Median (IQR), placebo 1 (0–2) and xylometazoline 1 (0–1), p = 0.28], hemodynamic changes, or complications between the two groups.ConclusionThe findings of this study do not support the administration of topical nasal xylometazoline in flexible bronchoscopy.Trial registryTrial registered on Clinicaltrials.gov, www.clinicaltrials.gov NCT03424889, on January 02, 2018.     

Peak Troponin and CMR to Guide Management in Suspected ACS and Nonobstructive Coronary Arteries

BackgroundPatients presenting with acute coronary syndrome (ACS) and nonobstructive coronary arteries are a diagnostic dilemma. Cardiac magnetic resonance (CMR) has an overall diagnostic yield of ～75%; however, in ～25% of patients, CMR does not identify any myocardial injury. Identifying the underlying diagnosis has important clinical implications for patients’ management and outcome.ObjectivesThe authors sought to assess whether the combination of CMR and peak troponin levels in patients with ACS and nonobstructive coronary arteries would lead to increased diagnostic yield.MethodsConsecutive patients with ACS and nonobstructive coronary arteries without an obvious cause underwent CMR. The primary endpoint of the study was the diagnostic yield of CMR. The Youden index was used to find the optimal diagnostic cut point for peak troponin T to combine with CMR to improve diagnostic yield. Logistic or Cox regression models were used to estimate predictors of a diagnosis by CMR.ResultsA total of 719 patients met the inclusion criteria. The peak troponin T threshold for optimal diagnostic sensitivity and specificity was 211 ng/L. Overall, CMR has a diagnostic yield of 74%. CMR performed <14 days from presentation and with a peak troponin of ≥211 ng/L (n = 198) leads to an improved diagnostic yield (94% vs 72%) compared with CMR performed ≥14 days (n = 245). When CMR was performed <14 days and with a peak troponin of <211 ng/L, the diagnostic yield was 76% (n = 86) compared with 53% (n = 190) when performed ≥14 days. An increase in 1 peak troponin decile increases the odds of the CMR identifying a diagnosis by 20% (OR: 1.20; P = 0.008, 95% CI: 1.05-1.36).ConclusionsThe combination of CMR performed <14 days from presentation and peak troponin T ≥211 ng/L leads to a very high diagnostic yield (94%) on CMR. The diagnostic yield remains high (72%) even when CMR is performed ≥14 days from presentation, but reduces to 53% when peak troponin T was <211 ng/L.     

Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center,Randomized Study

ObjectivesThis study aimed to compare the efficacy and safety of the distal transradial approach (dTRA) versus the conventional transradial approach (TRA) for coronary angiography and percutaneous coronary interventions.BackgroundThe recommended approach for coronary procedures is TRA. However, it is associated with radial artery occlusion (RAO). The dTRA could potentially decrease the incidence of RAO.MethodsOne thousand forty-two consecutive patients were randomized (1:1) to right dTRA or TRA. The primary endpoint was the rate of RAO, which was evaluated by Doppler ultrasound at 60 days after randomization.ResultsFive hundred eighteen and 524 patients were randomized to dTRA and TRA, respectively. Follow-up Doppler evaluation of the radial artery was accomplished in 404 (78.0%) patients in the dTRA group and 392 (74.8%) in the TRA group. The rate of RAO was significantly reduced in the dTRA group compared with TRA group (3.7% vs 7.9%, respectively; P = 0.014). The rate of successful sheath insertion was lower in the dTRA group compared with the TRA group (78.7% vs 94.8%, respectively; P < 0.001). More punctures (median = 2 [IQR: 1-3] vs median = 1 [IQR: 1-2]; P < 0.001) and a longer time (120 vs 75 seconds; P < 0.001) were required for sheath insertion in the dTRA group compared with the TRA group. The hemostasis time was shorter in the dTRA group compared with the TRA group (60 vs 120 minutes; P < 0.001). The dose area product was higher in the dTRA group (median = 32,729 in the dTRA vs 28,909 cGy/cm² in the TRA group; P = 0.02). No significant differences were observed in the secondary safety endpoints (bleeding [Bleeding Academic Research Consortium ≥2] and severe radial artery spasm).ConclusionsAccording to our study, dTRA was associated with a lower rate of forearm RAO, a shorter time of hemostasis, a higher crossover rate and dose area product, and a longer procedural time compared with TRA.     

Randomized Clinical Trial on Prevention of Radial Occlusion After Transradial Access Using Nitroglycerin: PATENS Trial

ObjectivesThe aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency.BackgroundThe TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO.MethodsThe authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 μg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound.ResultsA total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed re-establishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO.ConclusionsThe routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).     

Impact of Echocardiographic Guidance on Safety and Efficacy of Left Atrial Appendage Closure: An Observational Study

ObjectivesThe aim of this study was to evaluate the impact of echocardiographic guidance on the safety and efficacy of left atrial appendage closure (LAAC).BackgroundExpert consensus documents recommend intraprocedural imaging by means of either transesophageal echocardiography or intracardiac echocardiography to guide LAAC. However, no evidence exists that intraprocedural echocardiographic guidance in addition to fluoroscopy improves the safety and efficacy of LAAC.MethodsConsecutive LAAC procedures performed at a high-volume center between January 2009 and October 2020 were stratified on the basis of intraprocedural imaging modalities, including fluoroscopic guidance (FG) only or intraprocedural echocardiographic guidance (EG) in addition to fluoroscopy. The primary safety endpoint was the composite of procedure-related complications occurring within 7 days after the procedure. Technical success at 7 days and at follow-up were secondary endpoints.ResultsAmong 811 LAAC procedures, 549 (67.7%) and 262 (32.3%) were assigned to the FG and EG groups, respectively. After adjusting for confounders, EG remained associated with a lower rate of the primary safety endpoint (3.4% vs 9.1%; P = 0.004; adjusted odds ratio [OR]: 0.31; 95% CI: 0.11-0.90; P = 0.030). Technical success trended higher at 7 days (92.1% vs 87.2%; P = 0.065; adjusted OR: 1.68; 95% CI: 0.95-3.01; P = 0.079) and was significantly improved with EG compared with FG (87.6% vs 79.9%; P = 0.018; OR: 4.06; 95% CI: 1.60-10.27; P = 0.003) after a median follow-up period of 4.9 months (interquartile range: 3.4 months-6.2 months).ConclusionsIn a large cohort of consecutive LAACs, the use of intraprocedural echocardiography to guide intervention in addition to standard fluoroscopy was associated with lower risks for procedural complications and higher mid-term technical success rates.     

Center Valve Preference and Outcomes of Transcatheter Aortic Valve Replacement: Insights From the AMTRAC Registry

BackgroundData on outcomes of transcatheter aortic valve replacement (TAVR) using balloon-expandable valves (BEVs) or self-expandable valves (SEVs) as well as the impact of center valve preference on these outcomes are limited.ObjectivesThe aim of this study was to compare outcomes of TAVR procedures using third-generation BEVs and SEVs stratified by center valve preference.MethodsIn a multicenter registry (n = 17), 13 centers exhibited valve preference (66.6%-90% of volume) and were included. Outcomes were compared between BEVs and SEVs stratified by center valve preference.ResultsIn total, 7,528 TAVR procedures (3,854 with SEVs and 3,674 with BEVs) were included. The mean age was 81 years, and the mean Society of Thoracic Surgeons score was 5.2. Baseline characteristics were similar between BEVs and SEVs. Need for pacemaker implantation was higher with SEVs at BEV- and SEV-dominant centers (17.8% vs 9.3% [P < 0.001] and 12.7% vs 10.0% [P = 0.036], respectively; HR: 1.51; P for interaction = 0.021), risk for cerebrovascular accident was higher with SEVs at BEV-dominant but not SEV-dominant centers (3.6% vs 1.1% [P < 0.001] and 2.2% vs 1.4% [P = 0.162]; HR: 2.08; P for interaction < 0.01). Aortic regurgitation greater than mild was more frequent with SEVs at BEV-dominant centers and similar with BEVs regardless of center dominance (5.2% vs 2.8% [P < 0.001] and 3.4% vs 3.7% [P = 0.504], respectively). Two-year mortality was higher with SEVs at BEV-dominant centers but not at SEV-dominant centers (21.9% vs 16.9% [P = 0.021] and 16.8% vs 16.5% [P = 0.642], respectively; HR: 1.20; P for interaction = 0.032).ConclusionsPeriprocedural outcomes, aortic regurgitation greater than mild, and 2-year mortality are worse when TAVR is performed using SEVs at BEV-dominant centers. Outcomes are similar regardless of valve type at SEV-dominant centers. The present results stress the need to account for this factor when comparing BEV and SEV outcomes. (The Aortic+Mitral Transcatheter [AMTRAC] Valve Registry; NCT04031274)     

Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial

BackgroundCurrently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. A large-scale, international, randomized trial comparing RAO with TRA and DRA is lacking.ObjectivesThe aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO.MethodsDISCO RADIAL (Distal vs Conventional Radial Access) was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA or TRA with systematic implementation of best practices to reduce RAO. The primary endpoint was the incidence of forearm RAO assessed by vascular ultrasound at discharge. Secondary endpoints include crossover, hemostasis time, and access site–related complications.ResultsOverall, 657 patients underwent TRA, and 650 patients underwent DRA. Forearm RAO did not differ between groups (0.91% vs 0.31%; P = 0.29). Patent hemostasis was achieved in 94.4% of TRA patients. Crossover rates were higher with DRA (3.5% vs 7.4%; P = 0.002), and median hemostasis time was shorter (180 vs 153 minutes; P < 0.001). Radial artery spasm occurred more with DRA (2.7% vs 5.4%; P = 0.015). Overall bleeding events and vascular complications did not differ between groups.ConclusionsWith the implementation of a rigorous hemostasis protocol, DRA and TRA have equally low RAO rates. DRA is associated with a higher crossover rate but a shorter hemostasis time.     

Femoral or Radial Approach in Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial

ObjectivesThe aim of this study was to compare transradial access (TRA) with transfemoral access (TFA) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI).BackgroundTRA reduces the risk for vascular access complications but may make complex PCI, such as CTO PCI, more challenging.MethodsFORT CTO (Femoral or Radial Approach in the Treatment of Coronary Chronic Total Occlusion) (NCT03265769) was a prospective, noninferiority, randomized controlled study of TRA vs TFA for CTO PCI. The primary study endpoint was procedural success, defined as technical success without any in-hospital major adverse cardiovascular events. The secondary study endpoint was major access-site complications.ResultsBetween 2017 and 2021, 610 of 800 patients referred for CTO PCI at 4 centers were randomized to TRA (n = 305) or TFA (n = 305). Mean J-CTO (Multicenter CTO Registry in Japan) (2.1 ± 0.1 vs 2.2 ± 0.1; P = 0.279), PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) (1.3 ± 0.9 vs 1.1 ± 1.0; P = 0.058) and PROGRESS CTO complication (2.4 ± 1.8 vs 2.3 ± 1.8; P = 0.561) scores and use of the retrograde approach (11% vs 14%; P = 0.342) were similar in the TRA and TFA groups. TRA was noninferior to TFA for procedural success (84% vs 86%; P = 0.563) but had fewer access-site complications (2.0% vs 5.6%; P = 0.019). There was no difference between TFA and TRA in procedural duration, contrast volume, or radiation dose.COnclusionsTRA was noninferior to TFA for CTO PCI but had fewer access-site complications.     

Outcomes of Redo Transcatheter Aortic Valve Replacement According to the Initial and Subsequent Valve Type

BackgroundAs transcatheter aortic valve (TAV) replacement is increasingly used in patients with longer life expectancy, a sizable proportion will require redo TAV replacement (TAVR). The unique configuration of balloon-expandable TAV (bTAV) vs a self-expanding TAV (sTAV) potentially affects TAV-in-TAV outcome.ObjectivesThe purpose of this study was to better inform prosthesis selection, TAV-in-TAV outcomes were assessed according to the type of initial and subsequent TAV.MethodsPatients from the Redo-TAVR registry were analyzed using propensity weighting according to their initial valve type (bTAV [n = 115] vs sTAV [n = 106]) and subsequent valve type (bTAV [n = 130] vs sTAV [n = 91]).ResultsPatients with failed bTAVs presented later (vs sTAV) (4.9 ± 2.1 years vs 3.7 ± 2.3 years; P < 0.001), with smaller effective orifice area (1.0 ± 0.7 cm² vs 1.3 ± 0.8 cm²; P = 0.018) and less frequent dominant regurgitation (16.2% vs 47.3%; P < 0.001). Mortality at 30 days was 2.3% (TAV-in-bTAV) vs 0% (TAV-in-sTAV) (P = 0.499) and 1.7% (bTAV-in-TAV) vs 1.0% (sTAV-in-TAV) (P = 0.612); procedural safety was 72.6% (TAV-in-bTAV) vs 71.2% (TAV-in-sTAV) (P = 0.817) and 73.2% (bTAV-in-TAV) vs 76.5% (sTAV-in-TAV) (P = 0.590). Device success was similar according to initial valve type but higher with subsequent sTAV vs bTAV (77.2% vs 64.3%; P = 0.045), primarily because of lower residual gradients (10.3 mm Hg [8.9-11.7 mm Hg] vs 15.2 mm Hg [13.2-17.1 mm Hg]; P < 0.001). Residual regurgitation (moderate or greater) was similar after bTAV-in-TAV and sTAV-in-TAV (5.7%) and nominally higher after TAV-in-bTAV (9.1%) vs TAV-in-sTAV (4.4%) (P = 0.176).ConclusionsIn selected patients, no association was observed between TAV type and redo TAVR safety or mortality, yet subsequent sTAV was associated with higher device success because of lower redo gradients. These findings are preliminary, and more data are needed to guide valve choice for redo TAVR.     

Distal vs Conventional Radial Access for Coronary Angiography and/or Intervention: A Meta-Analysis of Randomized Trials

BackgroundEmerging evidence from randomized clinical trials (RCTs) comparing distal radial access (DRA) with conventional radial access (RA) is available.ObjectivesThe aim of this study was to provide a quantitative appraisal of the effects of DRA) vs conventional RA for coronary angiography with or without intervention.MethodsThe PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched for RCT comparing DRA vs conventional RA for coronary angiography and/or intervention. Data were pooled by meta-analysis using a random-effects model. The primary endpoint was radial artery occlusion (RAO) at the longest available follow-up.ResultsFourteen studies enrolling 6,208 participants were included. Compared with conventional RA, DRA was associated with a significant lower risk of RAO, either detected at latest follow-up (risk ratio [RR]: 0.36; 95% CI: 0.23-0.56; P < 0.001; number needed to treat [NNT] = 30) or in-hospital (RR: 0.32; 95% CI: 0.19-0.53; P < 0.001; NNT = 28), as well as EASY (Early Discharge After Transradial Stenting of Coronary Arteries) ≥II hematoma (RR: 0.51; 95% CI: 0.27-0.96; P = 0.04; NNT = 107). By contrast, DRA was associated with a higher risk of access site crossover (RR: 3.08; 95% CI: 1.88-5.06; P < 0.001; NNT = 12), a longer time for radial puncture (standardized mean difference [SMD]: 3.56; 95% CI: 0.96-6.16; P < 0.001), a longer time for sheath insertion (SMD: 0.37; 95% CI: 0.16-0.58; P < 0.001), and a higher number of puncture attempts (SMD: 0.59, 95% CI: 0.48-0.69; P < 0.001).ConclusionsCompared with conventional RA, DRA is associated with lower risks of RAO and EASY ≥II hematoma but requires longer time for radial artery cannulation and sheath insertion, more puncture attempts, and a higher access site crossover.     

Hyperventilation/Breath-Hold Maneuver to Detect Myocardial Ischemia by Strain-Encoded CMR: Diagnostic Accuracy of a Needle-Free Stress Protocol

ObjectivesThe purpose of this study was to evaluate the diagnostic accuracy of a fast, needle-free test for myocardial ischemia using fast Strain-ENCoded (fSENC) cardiovascular MR (CMR) after a hyperventilation/breath-hold maneuver (HVBH).BackgroundMyocardial stress testing is one of the most frequent diagnostic tests performed. Recent data indicate that CMR first-pass perfusion outperforms other modalities. Its use, however, is limited by the need for both, a vasodilatory stress and the intravenous application of gadolinium. Both are associated with added cost, safety concerns, and patient inconvenience. The combination of 2 novel CMR approaches, fSENC, an ultrafast technique to visualize myocardial strain, and HVBH, a physiological vasodilator, may overcome these limitations.MethodsPatients referred for CMR stress testing underwent an extended protocol to evaluate 3 different tests: 1) adenosine-perfusion; 2) adenosine-strain; and 3) HVBH-strain. Diagnostic accuracy was assessed using quantitative coronary angiography as reference.ResultsA total of 122 patients (age 66 ± 11years; 80% men) suspected of obstructive coronary artery disease were enrolled. All participants completed the protocol without significant adverse events. Adenosine-strain and HVBH-strain provided significantly better diagnostic accuracy than adenosine-perfusion, both on a patient level (adenosine-strain: sensitivity 82%, specificity 83%; HVBH-strain: sensitivity 81%, specificity 86% vs. adenosine-perfusion: sensitivity 67%, specificity 92%; p < 0.05) and territory level (adenosine-strain: sensitivity 67%, specificity 93%; HVBH-strain: sensitivity 63%, specificity 95% vs. adenosine-perfusion: sensitivity 49%, specificity 96%; p < 0.05). However, these differences in diagnostic accuracy disappear by excluding patients with history of coronary artery bypass graft or previous myocardial infarction. The response of longitudinal strain differs significantly between ischemic and nonischemic segments to adenosine (ΔLS_ischemic = 0.6 ± 5.4%, ΔLS_nonischemic = −0.9 ± 2.7%; p < 0.05) and HVBH (ΔLS_ischemic = 1.3% ± 3.8%, ΔLS_nonischemic = −0.3 ± 1.8%; p = 0.002). Test duration of HVBH-strain (t = 64 ± 2 s) was significantly shorter compared with adenosine-strain (t = 184 ± 59 s; p < 0.0001) and adenosine-perfusion (t = adenosine-perfusion: 172 ± 59 s; p < 0.0001).ConclusionsHVBH-strain has a high diagnostic accuracy in detecting significant coronary artery stenosis. It is not only significantly faster than any other method but also neither requires contrast agents nor pharmacological stressors.     

Sex Differences in Safety and Effectiveness of LAAO: Insights From the Amulet IDE Trial

BackgroundWomen have higher rates of acute complications after left atrial appendage occlusion (LAAO). However, data on long-term safety and effectiveness are limited.ObjectivesThe aim of this study was to examine sex-specific short- and long-term outcomes after LAAO in the Amulet IDE (Amplatzer? Amulet? LAA Occluder) trial.MethodsThe following outcomes were compared between men and women: in-hospital complications, device-related outcomes (peridevice leak at 45 days and device-related thrombus at 18 months), and long-term clinical outcomes (death, thromboembolism, and bleeding). Subanalyses for the interaction between sex and device type were performed.ResultsA total of 1,833 patients underwent attempted device implantation (917 with the Amulet and 916 with the Watchman), of whom 734 were women (40%). Device success was 97.4% in men and 97.1% in women (P = 0.60). Rates of major in-hospital adverse events were higher in women (4.4% vs 1.9%; P < 0.01), driven by major bleeding (3.7% vs 1.0%; P < 0.01) and pericardial effusion requiring intervention (2.0% vs 0.5%; P < 0.01). Peridevice leak and device-related thrombus were similar in men and women (18.3% vs 18.9% [P = 0.78] and 3.3% vs 5.0% [P = 0.10], respectively). There were no differences between men and women in rates of ischemic stroke or systemic embolism (2.6% vs 2.6%; P = 0.98), transient ischemic attack (1.3% vs 1.6%; P = 0.69), hemorrhagic stroke (0.5% vs 0.4%; P = 0.88), major bleeding (10.1% vs 10.9%; P = 0.49), cardiovascular death (4.3% vs 3.5%; P = 0.45), or all-cause death (8.9% vs 6.9%; P = 0.16).ConclusionsIn the Amulet IDE trial, long-term clinical outcomes including effectiveness following LAAO were comparable in men and women despite the higher rates of in-hospital complications due to major bleeding and pericardial effusion in women. (Amplatzer? Amulet? LAA Occluder Trial [Amulet IDE]; NCT02879448)     

Functional Coronary Angiography–Derived Index of Microcirculatory Resistance in Patients With ST-Segment Elevation Myocardial Infarction

ObjectivesThe aim of this study was to evaluate the diagnostic accuracy and prognostic implications of angiography-derived index of microcirculatory resistance (angio-IMR) in patients with ST-segment elevation myocardial infarction (STEMI).BackgroundThe index of microcirculatory resistance (IMR) is a reliable invasive measure of coronary microvascular dysfunction in patients with STEMI. A functional coronary angiography–derived method to estimate IMR is a wire- and hyperemic agent–free alternative to IMR.MethodsThe study population consisted of 2 independent cohorts. The diagnostic cohort comprised patients with IMR from the culprit vessel immediately after successful primary percutaneous coronary intervention (n = 31). The prognostic cohort was patients with STEMI who were successfully treated with primary percutaneous coronary intervention and followed for 10 years from the index procedure (n = 309). Angio-IMR was calculated using computational flow and pressure simulation. The primary outcome was a composite of cardiac death and readmission for heart failure over 10 years of follow-up.ResultsIn the diagnostic cohort, angio-IMR correlated well with IMR (R = 0.778; P < 0.001). Sensitivity, specificity, accuracy, and area under the curve of angio-IMR to predict IMR >40 U were 75.0%, 84.2%, 80.6%, and 0.899 (95% confidence interval: 0.786-0.949), respectively. In the prognostic cohort, patients with angio-IMR >40 U showed significantly higher risk for cardiac death or readmission for heart failure than did those with angio-IMR ≤40 U (46.7% vs 16.6%; adjusted hazard ratio: 2.909; 95% CI: 1.670-5.067; P < 0.001). Angio-IMR >40 U was an independent predictor of cardiac death or readmission for heart failure (hazard ratio: 2.173; 95% CI: 1.157-4.079; P = 0.016) and showed incremental prognostic value compared with a model with clinical risk factors only (C index = 0.726 vs 0.666 [P < 0.001], net reclassification index = 0.704 [P < 0.001]).ConclusionsAngio-IMR showed high correlation and diagnostic accuracy to predict IMR. Patients with STEMI with angio-IMR >40 U showed a significantly higher risk for cardiac death or readmission for heart failure than those with preserved angio-IMR values. (Prognostic Implication of Angiography-Derived IMR in STEMI Patients; NCT04628377)     

Differences in Demographics and Outcomes Between Men and Women With Spontaneous Coronary Artery Dissection

BackgroundSpontaneous coronary artery dissection (SCAD) is an increasingly recognized cause of myocardial infarction (MI) that most frequently affects women. The characteristics of men with SCAD are less well described.ObjectivesThe aim of this study was to describe the characteristics of men with SCAD.MethodsWe compared baseline demographics, clinical presentation, angiographic findings and cardiovascular outcomes of men and women in the Canadian SCAD Study. Major adverse cardiovascular events (MACE) were composite of death, MI, stroke or transient ischemic attack, heart failure hospitalization, and revascularization.ResultsOf 1,173 patients with SCAD, 123 (10.5%) were men. Men with SCAD were younger than women (mean age 49.4 ± 9.6 years vs 52.0 ± 10.6 years; P = 0.01). Men had lower rate of prior MI than women (0.8% vs 7.0%; P = 0.005). Men were less likely to have fibromuscular dysplasia (FMD) (27.8% vs 52.7%; P = 0.001), depression (9.8% vs 20.2%; P = 0.005), emotional stress (35.0% vs 59.3%; P < 0.001), or high score on the Perceived Stress Scale (3.5% vs 11.0%; P = 0.025) but were more likely to report isometric physical stress (40.2% vs 24.0%; P = 0.007). There was no difference in angiographic types of SCAD, but men had more circumflex artery (44.4% vs 30.9%; P = 0.001) and fewer right coronary artery (11.8% vs 21.7%; P = 0.0054) dissections. At median follow-up of 3.0 (IQR: 2.0-3.8) years, men had fewer hospital presentations with chest pain (10.6% vs 24.8%; P < 0.001). There were no differences in in-hospital events or follow-up MACE (7.3% vs 12.7%; P = 0.106).ConclusionsTen percent of SCAD patients were men. Men were younger and more likely to have a physical trigger but were less likely to have FMD, depression, or an emotional trigger. Men had less recurrent chest pain but no significant difference in MACE.     

Component-resolved diagnostics can be useful for identifying hazelnut allergy in Japanese children

BackgroundCor a 9 and Cor a 14 are effective markers for predicting hazelnut allergy. However, there have been no reports on the component-resolved diagnostics (CRD) of hazelnut allergy using an oral food challenge (OFC) for diagnosis in Asia. We hypothesized that CRD would improve the accuracy of diagnosing hazelnut allergies in Japanese children.MethodsWe recruited 91 subjects (median age: 7.3 years) who were sensitized to hazelnuts and had performed a hazelnut OFC at the National Hospital Organization Sagamihara National Hospital between 2006 and 2017. All subjects were classified as allergic or asymptomatic to 3 g of hazelnuts. The sIgE levels (hazelnut/Cor a 1/Cor a 8/Cor a 9/Cor a 14/alder pollen) were measured using ImmunoCAP. We aimed to determine the predictive factors of hazelnut allergy.ResultsNine subjects (10%) were allergic to ≤3 g of hazelnuts. Levels of sIgE for Cor a 9 in hazelnut-allergic subjects were significantly higher than those in asymptomatic subjects (4.47 vs. 0.76 kU_A/L, p = 0.039). Levels of sIgE to alder pollen and Cor a 1 in hazelnut-allergic subjects were significantly lower than those in asymptomatic subjects (<0.10 vs 13.0 kU_A/L, p = 0.004; <0.10 vs 5.03 kU_A/L, p = 0.025). The area under the receiver operating characteristics curve for hazelnut/alder/Cor a 1/Cor a 9 was 0.55/0.78/0.72/0.71, respectively, with p = 0.651/0.006/0.029/0.040, respectively.ConclusionsThe findings of a high sIgE level for Cor a 9 and a low sIgE level for Cor a 1 can improve the diagnostic accuracy to better identify Japanese children sensitized to hazelnuts.     

Prognostic value of frontal QRS-T angle in predicting survival after primary percutaneous coronary revascularization/coronary artery bypass grafting for ST-elevation myocardial infarction

BackgroundFrontal QRS-T angle (FQRST) has previously been correlated with mortality in patients with stable coronary artery disease, but its role as survival predictor after ST-elevation myocardial infarction (STEMI) remains unknown.MethodsWe evaluated 267 consecutive patients with STEMI undergoing reperfusion or coronary artery bypass grafting. Data assessed included demographics, clinical presentation, electrocardiograms, medical therapy, and one-year mortality.ResultsOf 267 patients, 187 (70%) were males and most (49.4%) patients were Caucasian. All-cause mortality was significantly higher among patients with the highest (101–180°) FQRST [28% vs. 15%, p = 0.02]. Patients with FQRST 1–50° had higher survival (85.6%) compared with FQRST = 51–100° (72.3%) and FQRST = 101–180° (67.9%), [log rank, p = 0.01]. Adjusting for significant variables identified during univariate analysis, FQRST (OR = 2.04 [95% CI: 1.31–13.50]) remained an independent predictor of one-year mortality. FQRST-based risk score (1–50° = 0 points, 51–100° = 2 points, 101–180° = 5 points) had excellent discriminatory ability for one-year mortality when combined with Mayo Clinic Risk Score (C statistic = 0.875 [95%CI: 0.813–0.937]. A high (>4 points) FQRST risk score was associated with greater mortality (32% vs. 19%, p = 0.02) and longer length of stay (6 vs. 2 days, p < 0.001).ConclusionFQRST represents a novel independent predictor of one-year mortality in patients with STEMI undergoing reperfusion. A high FQRST-based risk score was associated with greater mortality and longer length of stay and, after combining with Mayo Clinic Risk Score, improved discriminatory ability for one-year mortality.     

Clinical Applications of FDG-PET Scan in Arrhythmic Myocarditis

Background¹⁸F-fluorodeoxyglucose positron emission tomography (FDG-PET) scan has no recognized role in diagnosis, prognosis, and disease monitoring in patients with arrhythmic myocarditis.ObjectivesThe purpose of this study was to investigate the value of FDG-PET scan in arrhythmic myocarditis.MethodsThe authors enrolled 75 consecutive patients (age 47 ± 14 years, 65% men) undergoing FDG-PET scan for arrhythmic myocarditis. Myocarditis was diagnosed by endomyocardial biopsy (EMB) and, whenever applicable, cardiac magnetic resonance (CMR).ResultsIndications for FDG-PET scan included either contraindication to CMR (n = 50) or mismatch between CMR and EMB (n = 25). Overall, 50 patients (67%) had positive FDG-PET. Sensitivity was 75% referring to EMB, and 73% to CMR. Specificity was 67% referring to EMB, and 59% to CMR. FDG-PET accuracy was lower in the presence of borderline myocarditis, and either late (>30 days) or on-immunosuppression FDG-PET scanning. Anteroseptal distribution pattern, found in 12 of 50 (24%) patients including 7 of 7 cardiac sarcoidosis cases, was associated with greater occurrence of ventricular arrhythmias and atrioventricular blocks in 4.2 ± 1.7 years of follow-up (10 of 12 vs 7 of 38, and 7 of 12 vs 0 of 38, respectively; both P < 0.001). In 39 patients (52%), FDG-PET was repeated by 13 ± 2 months, allowing immunosuppression withdrawal after FDG uptake normalization either by first (76%) or second reassessment (24%).ConclusionsFDG-PET scan may be a clinically useful diagnostic technique in arrhythmic myocarditis, in particular when CMR is unsuitable because of irregular heartbeat or implantable cardioverter-defibrillator–related artifacts. Anteroseptal FDG distribution is associated with a worse arrhythmic outcome and should raise the suspicion of cardiac sarcoidosis. During follow-up, repeated FDG-PET allows myocarditis monitoring to guide immunosuppression withdrawal.     

Comparison of Doppler Flow Velocity and Thermodilution Derived Indexes of Coronary Physiology

ObjectivesThe aim of this study was to compare Doppler flow velocity and thermodilution-derived indexes and to determine the optimal thermodilution-based diagnostic thresholds for coronary flow reserve (CFR).BackgroundThe majority of clinical data and diagnostic thresholds for flow-based indexes are derived from Doppler measurements, and correspondence with thermodilution-derived indices remain unclear.MethodsAn international multicenter registry was conducted among patients who had coronary flow measurements using both Doppler and thermodilution techniques in the same vessel and during the same procedure.ResultsPhysiological data from 250 vessels (in 149 patients) were included in the study. A modest correlation was found between thermodilution-derived CFR (CFR_thermo) and Doppler-derived CFR (CFR_Doppler) (r² = 0.36; P < 0.0001). CFR_thermo overestimated CFR_Doppler (mean 2.59 ± 1.46 vs 2.05 ± 0.89; P < 0.0001; mean bias 0.59 ± 1.24 by Bland-Altman analysis), the relationship being described by the equation CFR_thermo = 1.04 × CFR_Doppler + 0.50. The commonly used dichotomous CFR_thermo threshold of 2.0 had poor sensitivity at predicting a CFR_Doppler value <2.5. The optimal CFR_thermo threshold was 2.5 (sensitivity 75.54%, specificity 81.25%). There was only a weak correlation between hyperemic microvascular resistance and index of microvascular resistance (r² = 0.19; P < 0.0001), due largely to variation in the measurement of flow by each modality. Forty-four percent of patients were discordantly classified as having abnormal microvascular resistance by hyperemic microvascular resistance (≥2.5 mm Hg · cm^?1 · s) and index of microvascular resistance (≥25).ConclusionsCFR calculated by thermodilution overestimates Doppler-derived CFR, while both parameters show modest correlation. The commonly used CFR_thermo threshold of 2.0 has poor sensitivity for identifying vessels with diminished CFR, but using the same binary diagnostic threshold as for Doppler (<2.5) yields reasonable diagnostic accuracy. There was only a weak correlation between microvascular resistance indexes assessed by the 2 modalities.