Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial.

BACKGROUND: Both transcatheter edge-to-edge repair (TEER) of mitral regurgitation or left atrial appendage closure (LAAC) require periprocedural anticoagulation with unfractionated heparin (UFH) that is administered either before or immediately after transseptal puncture (TSP). The optimal timing of UFH administration (before or after TSP) is unknown. The Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions trial (STOP CLOT Trial) was designed to determine if early anticoagulation is effective in reducing ischemic complications without increasing the risk of periprocedural bleeding. METHODS: The STOP CLOT trial is a multicenter, prospective, double-blind, placebo-controlled, randomized trial. A total of 410 patients scheduled for TEER or LAAC will be randomized 1:1 either early UFH administration (iv. bolus of 100 units/kg UFH or placebo, given after obtaining femoral vein access and at least 5 minutes prior to the start of the TSP) or late UFH administration (iv. bolus of 100 units/kg UFH or placebo given immediately after TSP). Prespecified preliminary statistical analysis will be performed after complete follow-up of the first 196 randomized subjects. To ensure blinding, a study nurse responsible for randomization and UFH/placebo preparation is not involved in the care of the patients enrolled into the study. The primary study endpoint is a composite of (1) major adverse cardiac and cerebrovascular events (death, stroke, TIA, myocardial infarction, or peripheral embolization) within 30 days post-procedure, (2) intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transesophageal echocardiography, or (3) occurrence of new ischemic lesions (diameter ≥4 mm) on brain magnetic resonance imaging performed 2 to 5 days after the procedure. The safety endpoint is the occurrence of moderate or severe bleeding complications during the index hospitalization. CONCLUSIONS: Protocols of periprocedural anticoagulation administration during structural interventions have never been tested in a randomized clinical trial. The Stop Clot trial may help reach consensus on the optimal timing of initiation of periprocedural anticoagulation. CLINICAL TRIALS REGISTRATION NUMBER: The study protocol is registered at ClinicalTrials.gov, identifier NCT05305612.

Computed tomographic characteristics of congenital coronary artery fistulas in an adult population.

BACKGROUND: Coronary artery fistulas (CAFs) are usually congenital coronary artery anomalies of termination. AIMS: This study aimed to assess the prevalence, anatomic characteristics, and clinical significance of CAFs detected by computed tomography (CT) in an adult population. METHODS: We performed 45 817 CT examinations in 39 066 subjects between 2008 and 2020. The electronic database was manually checked using specific keywords to identify patients with CAFs. The CT characteristics of CAFs were evaluated. CAF was defined as clinically significant if it was the most plausible cause of myocardial infarction, infective endocarditis, heart failure, death during follow-up, hospitalization, or if it required either percutaneous or surgical intervention. RESULTS: Of 39 066 patients, 56 CAFs were detected in 42 subjects (20 men, 47.6%) with a prevalence of 0.11%. Most CAFs originated from the right coronary artery (RCA) (48.2%) and drained into the pulmonary artery (PA) (58.9%). CAFs terminating in the PA were more frequently multiple (P <0.001) and tortuous (P <0.001) as compared to CAFs without PA drainage. Clinically significant CAFs, identified in 7 of 42 patients, were more common in younger (P = 0.03) and male (P = 0.04) subjects and had larger lumen area and diameter at the site of origin (P = 0.03, P = 0.03, respectively). CONCLUSIONS: In the unselected adult population undergoing coronary CT angiography, the RCA and the PA are the most common sites of origin and termination of CAFs, respectively. CAFs draining into the PA are more often multiple and tortuous. Clinically meaningful CAFs are larger and most frequently detected in younger and male patients.

Pericoronary adipose tissue density is increased in patients with recent spontaneous coronary dissection.

OBJECTIVE: Inflammatory activity is one of the potential mechanisms of spontaneous coronary artery dissection (SCAD). Recently, the pericoronary adipose tissue attenuation (PCAT) derived from CT angiography (CTA) has been established as a method for measuring vascular inflammation. We aimed to characterise the pancoronary and vessel-specific PCAT in patients with and without recent SCAD. METHODS: The study comprised patients with SCAD referred to a tertiary centre between 2017 and 2022 who underwent CTA and were compared with individuals with no prior SCAD. PCAT was analysed on end-diastolic CTA reconstructions along proximal 40 mm of all major coronary vessels as well as the SCAD-related vessel. We analysed 48 patients with recent SCAD (median 6.1 (IQR 3.5-14.9) months since SCAD, 95.8% female) and 48 patients in the group without SCAD. RESULTS: Pancoronary PCAT was higher in patients with SCAD compared with those without SCAD (-80.6±7.9 vs -85.3 HU±6.1, p=0.002). Vessel-specific PCAT in patients with SCAD compared with patients without SCAD was higher for both the RCA (-80.9±9.5 vs -87.1±6.9 HU, p=0.001) and the LCA (-80.3±7.8 vs -83.4±7.2 HU, p=0.04). In patients with SCAD, PCAT of the SCAD-related vessel was not significantly different from averaged PCAT of unaffected vessels (-81.2±9.2 vs -80.6±7.6, p=0.74). There was no association between PCAT and the interval from SCAD to CTA. CONCLUSIONS: Patients with recent SCAD have higher PCAT compared with patients without SCAD, suggesting an increased perivascular inflammatory activity. This association is not restricted to the dissected vessel.

Transcatheter pulmonary denervation in patients with left heart failure with reduced ejection fraction and combined precapillary and postcapillary pulmonary hypertension: A prospective single center experience.

OBJECTIVES: The present study was a prospective, single-center, single-arm study to investigate the efficacy of transcatheter pulmonary artery denervation (TPADN) in patients with combined postcapillary and precapillary PH (Cpc-PH) associated with left heart failure with reduced ejection fraction (HF-rEF). BACKGROUND: Pulmonary hypertension (PH) in patients with left ventricular systolic dysfunction has a negative impact on outcome. METHODS: The combination of pulmonary artery systolic pressure (PAPs) ≥60 mmHg, transpulmonary pressure gradient (TPG) ≥12 mmHg, nonreversible mean PAP, and pulmonary vascular resistance (PVR) ≥3.5 Wood Units was considered as too high risk for heart transplantation (HTx). The clinical efficacy endpoint was an improvement in 6-min walking test and the hemodynamic endpoints were changes in PAPs, PVR, and TPG between baseline and 6 months. Circumferential radiofrequency applications were delivered around distal main, left and right pulmonary arteries. At each ablation point temperature was 45°C and energy 10 W. RESULTS: TPADN was performed in 10 patients. At 6-month in 5 patients we observed reduction in PAP, PVR, TPG, and DPG and then 1 had successful HTx, 2 are on HTx waiting list, 2 received LVADs, 2 patients did not improve, and 3 patients died. CONCLUSIONS: TPADN may be beneficial in selected patients with HF-rEF and Cpc-PH.

Comparison of transcatheter aortic valve implantation outcomes in patients younger than 85 years and those aged 85 years or older: a single-center study.

INTRODUCTION: The number of elderly patients requiring treatment of aortic stenosis is expected to grow steadily due to increasing lifespan. Transcatheter aortic valve implantation (TAVI) is an alternative treat­ ment for patients with aortic stenosis considered nonoptimal candidates for surgical valve replacement. OBJECTIVES: We aimed to assess age­related differences in 30­day and 1­year cardiovascular mortality, Valve Academic Research Consortium­2 (VARC­2)-defined complications in patients undergoing TAVI, by comparing outcomes in patients younger than 85 years and those aged 85 years or older. PATIENTS AND METHODS: The study group included patients who underwent TAVI at the Institute of Cardiology, Warsaw from January 2009 to July 2019. Clinical, procedural, and follow­up data were retrospectively collected and compared in 2 groups defined according to age: group 1, younger than 85 years (417) and group 2, aged 85 or older (200). RESULTS: The surgical risk profile assessed by the EuroSCORE II was significantly higher in the group of older patients (median [interquartile range], 6.5% [3.5%-17.3%] vs 7.2% [3.4%-18.1%]; P = 0.002); 30­day and 1­year cardiovascular mortality was 4.3% in group 1 as compared with 5% in group 2 (P = 0.69) and 10.8% in group 1 as compared with 9.4% in group 2 (P = 0.51), respectively. The rate of VARC­2­defined complications was similar in both groups, with the exception of major vascular com­ plications (3.12% vs 8.5%; P = 0.004) and major bleeding (10.8% vs 18.5%; P = 0.008), which were more prevalent in older patients. CONCLUSION: Cardiovascular mortality at 1 month and 1 year following TAVI is similar in patients aged 85 years or older and in those younger than 85 years.

Inter-ethnic differences in normal coronary anatomy between Caucasian (Polish) and Asian (Korean) populations.

PURPOSE: Little is known about ethnic differences in the size of coronary arteries in disease-free individuals. Our aim was to compare coronary artery dimensions between Asian and Caucasian population without atherosclerosis. METHODS: One hundred and twelve Caucasian patients without any discernible atherosclerosis detected on coronary computed tomography angiography were matched with 112 Asian patients using sex, age, coronary dominance pattern and body surface area (BSA). Maximal and minimal lumen areas (LA) and diameters (LD) of proximal and middle coronary segments were measured, and the mean values were used for analyses. RESULTS: Caucasians had larger LA and LD than Asian patients in all proximal coronary segments. Overall, the mean difference in LA and LD was 11.4 % and 5.2 %, respectively. Significant differences were observed for all proximal segments (left anterior descending: 13 % and 6%, left circumflex 14 % and 8% and right coronary artery 8% and 4% for LA and LD), but not for mid segments. The greatest difference between Caucasians and Asians was found in left main coronary artery (LMCA) LA (21.2 ±â€¯6.5 vs.16.8 ±â€¯5.4 mm2, p < 0.01 respectively). The independent predictors of larger LA and LD of LMCA and proximal coronary segments were male sex (p < 0.05), Caucasian ethnicity (p < 0.05), and left dominance pattern (p < 0.05). CONCLUSION: In subjects without atherosclerosis, Asians have smaller dimensions of all proximal coronary arteries, most prominently displayed in LMCA, than the Caucasians regardless of age, sex, or body size.

Transcatheter aortic valve replacement in patients with previous mitral valve replacement. A systematic study.

INTRODUCTION: Severe aortic stenosis (AS) is an ever-growing healthcare problem in ageing populations. Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of AS. However, TAVI in patients who have undergone mitral valve replacement (MVR) is associated with increased risk of mitral valve damage. Limited data exist on TAVI in patients with AS who underwent MVR in the past. AIM: To retrospectively assess the clinical characteristics, detailed echocardiographic and computed tomography measurements, procedural and in-hospital outcome as well as any valve intervention or major adverse cardiovascular events according to VARC-2 criteria at follow-up of patients with a history of MVR, who underwent TAVI. MATERIAL AND METHODS: Seventeen patients with a history of mitral valve operation, in whom TAVI was performed between 2010 and 2018, were identified. Of these, 15 underwent previous MVR. RESULTS: Overall, TAVI resulted in a decrease of mean transaortic gradient by 38.3 ±14 mm Hg (p < 0.001) and a decrease of maximal transaortic gradient by 58.6 ±27.6 mm Hg (p < 0.001). A successful immediate result was obtained in 14 (93.3%) patients. One tamponade occurred during TAVI, which was successfully treated with pericardiocentesis. Post-procedurally, no significant changes in transmitral gradients or mitral regurgitations were observed. Two patients died after hospital discharge, one due to possible internal bleeding and the other due to infection. CONCLUSIONS: TAVI in patients after MVR is feasible. Meticulous preinterventional echocardiographic and computed tomography planning is essential. Although recommended in previous reports, TEE guidance may not necessarily be obligatory during the procedure.

Intra-Right Ventricle Course of the Coronary Arteries on Computed Tomography Angiography.

BACKGROUND: The clinical relevance and anatomic characteristics of intracavitary coronary arteries coursing within the right ventricle (RV) are largely unknown. OBJECTIVES: The aim of our study was to assess the clinical and computed tomographic characteristics of patients diagnosed with intracavitary coronary arteries coursing within RV (intra-RV coronaries). METHODS: Electronic records from a single high-volume cardiac center were retrospectively screened for the presence of intra-RV coronaries among consecutive patients who underwent coronary computed tomography angiography (coronary CTA) from 2008 to 2019. RESULTS: Overall, 31,748 coronary CTA reports were evaluated, and 17 subjects with intra-RV coronaries were identified. None of these patients was referred for subsequent invasive coronary angiography. One patient underwent coronary artery bypass grafting, 1 patient had a history of percutaneous coronary intervention, and 1 patient had a concomitant coronary anomaly: left circumflex coronary artery originating from the right coronary artery. All of the involved coronaries (n = 17) were the left anterior descending coronary arteries (LADs). Typical segmental coronary course within RV was along the border between free RV wall and interventricular septum (beneath interventricular groove), often within trabeculae carneae of the RV. Only the midsegment and distal segment of the LAD traversed within the RV. The mean ± SD distance from the aorta to the coronary entrance into the RV was 74.5 ± 17.1 mm, whereas the mean ± SD intra-RV coronary length was 25.1 ± 14.0 mm. CONCLUSIONS: Intra-RV course of the coronaries in an adult CTA population is an infrequent anatomical variant involving LAD. It may require additional attention during interventional and surgical interventions.

Elective versus rescue balloon aortic valvuloplasty for critical aortic stenosis.

BACKGROUND: Balloon aortic valvuloplasty (BAV) may be considered a bridge to further intervention in hemodynamically unstable patients or patients with symptomatic severe aortic stenosis (AS). AIMS: This study aimed to retrospectively compare periprocedural and in­hospital outcomes of AS patients treated with elective BAV (group 1) and rescue BAV (group 2). METHODS: We identified 35 patients in whom BAV was performed between 2010 and 2018. Among them, 16 were treated electively (group 1) and 19 urgently (group 2). RESULTS: Overall, BAV resulted in a significant decrease in the mean transaortic gradient by a median (interquartile range [IQR]) value of 5 (1-10) mm Hg (P <0.01) and the maximal transaortic gradient by a median (IQR) value of 13.5 (2.5-23.2) mm Hg (P <0.01). Postprocedural grade II aortic regurgitation rates increased from 8.6% to 17.1% (P = 0.48). Periprocedural death occurred in 4 patients (11.4%)-all from group 2 (21%) (P = 0.1). In­hospital death occurred in 15 patients (42.8%)-3 patients (18.7%) from group 1 and 12 patients (63.1%) from group 2 (P <0.01). During follow­up, a single patient underwent surgical aortic valve replacement, and transcatheter aortic valve implantation was performed in 4 individuals. A single patient died 22 months after BAV. CONCLUSIONS: Periprocedural and in­hospital mortality in patients with critical AS treated with BAV remains very high, especially in patients treated urgently.

Incidence, clinical correlates, timing, and consequences of acute thrombus formation in patients undergoing the MitraClip procedure.

BACKGROUND: Despite adequate heparinization, formation of fresh intracardiac thrombi during the MitraClip procedure was reported. AIMS: We aimed to evaluate the incidence and clinical consequences of intracardiac thrombus formation during the MitraClip device implantation. METHODS: Clinical data and transesophageal echocardiography findings obtained during MitraClip procedures in 100 consecutive patients (81 men; mean [SD] age, 67.8 [8.3] years) were reviewed. In all patients, a heparin bolus was given immediately after a successful transseptal puncture, and the activated clotting time above 250 seconds was maintained throughout the procedure. RESULTS: Thrombus formation was documented in 9 patients (9%). In 6 patients, thrombi formed on a transseptal needle/sheath (2 attached to the sheath in the right atrium and 4 on the sheath immediately after the puncture in the left atrium), and in 3 patients, on the MitraClip device in the left atrium (2 on a steerable guiding catheter and 1 on the clip delivery system). Overall, 6 thrombi (67%) formed prior to and 3 (33%) after heparin administration. All thrombi were transient and disappeared within minutes. No periprocedural ischemic stroke, transient ischemic attack, or other embolic complications were reported. Clinical characteristics were similar in patients with and without thrombi, except for lower left ventricular ejection fraction (LVEF; mean [SD], 23% [10%] and 30% [10%], respectively; P = 0.03). In-hospital death was reported in 6 patients: 2 with a visible thrombus and 4 without (P = 0.09). CONCLUSIONS: Transient thrombus formation is relatively common during the MitraClip procedure, especially in patients with low LVEF; however, acute clinical consequences are benign.

Impact of the Balloon Inflation Time and Pattern on the Coronary Stent Expansion.

OBJECTIVES: To assess the expansion pattern of coronary stents by using different balloon inflation times and pressures. BACKGROUND: The selection of coronary stent size and its proper deployment is crucial in coronary artery interventions, having an impact on the success of the procedure and further therapy. METHODS: Ten pairs of different stents were deployed under nominal pressure using sequential (5, 5, 10, and 10 seconds of repeated inflations, thus 30 seconds of summarized time) and continuous (30 seconds) deployment pattern. After each given time-point, intraluminal stent measurements were performed by optical coherence tomography (OCT) and intravascular ultrasound (IVUS). RESULTS: Both in-stent diameters and cross-section areas (CSA) of paired stents measured by OCT at all sequential time-points were significantly smaller compared to given manufacturers charts' values (90% to 94% for diameters and 81% to 88% for CSA, p<0.05). Significant increase of in-stent diameter and CSA was observed across the step-by-step deployment pattern. In-stent lumen measurements were significantly larger when sequential deployment pattern was applied compared to continuous deployment. Additional measurements were also done for overlapping segments of stents, showing smaller in-stent measurements of the latter compared to nonoverlapping segments. Validation of OCT and IVUS measurements using a phantom metallic tube showed perfect reproducibility with OCT and overestimation with IVUS (8% for diameters and 16% for CSA). CONCLUSIONS: Stent diameter after deployment is time-dependent and not only pressure-dependent. Different stent expansion behavior, depending on the applied deployment pattern (sequential and nonsequential), was observed.

Prevalence and Anatomic Characteristics of Single Coronary Artery Diagnosed by Computed Tomography Angiography.

Single coronary artery (SCA) is a rare congenital anomaly. We assessed the prevalence and anatomic characteristics of SCA diagnosed with coronary computed tomography angiography and compared the dimensions of the proximal SCA trunk with a reference group of 199 subjects with normal coronary arteries. We screened 30,230 patients who underwent coronary computed tomography angiography from 2008 to 2018 to identify 17 with SCA (age 55 ± 19.0 years, 8 men [47%]). The prevalence of SCA was 0.056%. SCA originated from the right sinus of Valsalva in 11 patients (65%) and from the left sinus of Valsalva in 6 subjects. According to Lipton's classification, the 17 SCAs were L1 (n = 5, 29%), L2-A (n = 1, 6%), R2-A (n = 2, 12%), R2-B (n = 6, 35%), R2-P (n = 2, 12%), and R3 (n = 1, 6%). (Lipton's classification consists of 3 groups and the division is based on the site of origin of SCA ["R" - right, "L" - left sinus of Valsalva] and its anatomical course relating to the ascending aorta and pulmonary trunk ["A" - anterior to the pulmonary trunk, "B" - between the aorta and pulmonary trunk, "P" - posterior to the aorta].) As compared with the reference group, SCA patients had shorter proximal trunks (5.0 ± 3.6 mm vs 8.6 ± 4.8 mm, p = 0.0012). The lumen area (LA) and lumen diameter of the proximal trunk in patients with SCA were larger than the LA and lumen diameter of the left main coronary artery from the reference group (49.5 ± 18.0 mm2 vs 21.3 ± 6.5 mm2, p <0.0001, and 7.8 ± 1.6 mm vs 5.1 ± 0.75 mm, p <0.0001, respectively). Moreover, the LA of the proximal SCA trunk was larger than the sum of respective measurement performed in left main coronary artery and proximal right coronary artery segments in the control group (49.5 ± 18.0 mm2 vs 34.0 ± 7.9mm2, p = 0.0001). In conclusion, the incidence of SCA is very low; but this condition is associated with significant enlargement of the proximal vessel segment.