Effect of Cangrelor on Infarct Size in ST-Segment-Elevation Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention: A Randomized Controlled Trial (The PITRI Trial).

BACKGROUND: The administration of intravenous cangrelor at reperfusion achieves faster onset of platelet P2Y12 inhibition than oral ticagrelor and has been shown to reduce myocardial infarction (MI) size in the preclinical setting. We hypothesized that the administration of cangrelor at reperfusion will reduce MI size and prevent microvascular obstruction in patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention. METHODS: This was a phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial conducted between November 2017 to November 2021 in 6 cardiac centers in Singapore. Patients were randomized to receive either cangrelor or placebo initiated before the primary percutaneous coronary intervention procedure on top of oral ticagrelor. The key exclusion criteria included presenting <6 hours of symptom onset; previous MI and stroke or transient ischemic attack; on concomitant oral anticoagulants; and a contraindication for cardiovascular magnetic resonance. The primary efficacy end point was acute MI size by cardiovascular magnetic resonance within the first week expressed as percentage of the left ventricle mass (%LVmass). Microvascular obstruction was identified as areas of dark core of hypoenhancement within areas of late gadolinium enhancement. The primary safety end point was Bleeding Academic Research Consortium-defined major bleeding in the first 48 hours. Continuous variables were compared by Mann-Whitney U test (reported as median [first quartile-third quartile]), and categorical variables were compared by Fisher exact test. A 2-sided P<0.05 was considered statistically significant. RESULTS: Of 209 recruited patients, 164 patients (78%) completed the acute cardiovascular magnetic resonance scan. There were no significant differences in acute MI size (placebo, 14.9% [7.3-22.6] %LVmass versus cangrelor, 16.3 [9.9-24.4] %LVmass; P=0.40) or the incidence (placebo, 48% versus cangrelor, 47%; P=0.99) and extent of microvascular obstruction (placebo, 1.63 [0.60-4.65] %LVmass versus cangrelor, 1.18 [0.53-3.37] %LVmass; P=0.46) between placebo and cangrelor despite a 2-fold decrease in platelet reactivity with cangrelor. There were no Bleeding Academic Research Consortium-defined major bleeding events in either group in the first 48 hours. CONCLUSIONS: Cangrelor administered at the time of primary percutaneous coronary intervention did not reduce acute MI size or prevent microvascular obstruction in patients with ST-segment-elevation MI given oral ticagrelor despite a significant reduction of platelet reactivity during the percutaneous coronary intervention procedure. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03102723.

In between the cracks.

A 65-year-old man with end-stage renal failure, severe aortic stenosis, and triple vessel coronary artery disease was admitted for percutaneous coronary intervention to the left anterior descending artery prior to transcatheter aortic valve replacement.

Safety and efficacy of cerebral embolic protection in transcatheter aortic valve implantation: an updated meta-analysis.

Background: The use of cerebral embolic protection devices during transcatheter aortic valve implantation (TAVI) reveals conflicting data. Aims: This updated meta-analysis aims to evaluate the efficacy and safety of the SENTINEL Cerebral Protection System. Methods: A literature search for relevant studies up to September 2022 was performed. Study outcomes were divided based on time period - overall (up to 30 days) and short (≤7 days). The outcomes studied include stroke (disabling, non-disabling), mortality, neuroimaging findings, transient ischaemic attack, acute kidney injury and major vascular and bleeding complications. Results: A total of 15 studies involving 294,134 patients were included. Regarding overall outcomes, significant reductions were noted for mortality (odds ratio [OR] 0.60, 95% confidence interval [CI]: 0.41-0.88; p=0.008), all stroke (OR 0.64, 95% CI: 0.46-0.88; p=0.006) and disabling stroke (OR 0.42, 95% CI: 0.23-0.74; p=0.003) using the SENTINEL device. No significant differences were noted for other outcomes. There was significant heterogeneity across the studies for mortality (p=0.013) and all stroke (p=0.003). Including only randomised data (n=4), there was only significant reduction in the incidence of disabling stroke (OR 0.39, 95% CI: 0.17-0.89; p=0.026) in the SENTINEL group. In studies reporting ≤7-day outcomes (n=8), use of the SENTINEL device demonstrated significantly lower rates of all stroke (p<0.001), disabling stroke (p<0.001) and major bleeding complications (p=0.02). No differences in neuroimaging outcomes were noted. Conclusions: In this updated meta-analysis, use of the SENTINEL Cerebral Protection System was associated with lower rates of mortality, all stroke and disabling stroke, although significant heterogeneity was noted for mortality and all stroke. Including exclusively randomised data, there was only significant reduction in the incidence of disabling stroke. No significant adverse outcomes with device use were noted.

Transcatheter closure of a coronary artery to pulmonary artery fistula with two sequential giant aneurysms.

A 73-year-old female presented with exertional dyspnea and was found to have a coronary artery to pulmonary artery fistula with 2 sequential giant aneurysms. Her chest radiograph showed a mass above the cardiac silhouette.

Role of Invasive Strategy for Non-ST-Elevation Myocardial Infarction in Patients With Chronic Kidney Disease: A Systematic Review and Meta-Analysis.

Patients with chronic kidney disease (CKD) have traditionally been excluded from randomized trials. We aimed to compare percutaneous coronary intervention versus conservative management, and early intervention (EI; within 24 hours of admission) versus delayed intervention (DI; after 24 to 72 hours of admission) in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and concomitant CKD. An electronic literature search was performed to search for studies comparing invasive management to conservative management or EI versus DI in patients with NSTEMI with CKD. The primary outcome was all-cause mortality; secondary outcomes were acute kidney injury (AKI) or dialysis, major bleeding, and recurrent MI. Hazard ratios (HRs) for the primary outcome and odds ratios for secondary outcomes were pooled in random-effects meta-analyses. Eleven studies (140,544 patients) were analyzed. Invasive management was associated with lower mortality than conservative management (HR 0.62, 95% confidence interval 0.57 to 0.67, p <0.001, I2 = 47%), with consistent benefit across all CKD stages, except CKD 5. There was no significant mortality difference between EI and DI, but subgroup analyses showed significant benefit for EI in stage 1 to 2 CKD (HR 0.75, 95% confidence interval 0.58 to 0.97, p = 0.03, I2 = 0%), with no significant difference in stage 3 and 4 to 5 CKD. Invasive strategy was associated with higher odds of AKI or dialysis and major bleeding, but lower odds of recurrent MI compared with conservative management. In conclusion, in patients with NSTEMI and CKD, an invasive strategy is associated with significant mortality benefit over conservative management in most patients with CKD, but at the expense of higher risk of AKI and bleeding. EI appears to benefit those with early stages of CKD. Trial Registration: PROSPERO CRD42023405491.

An Updated Meta-Analysis on the Clinical Outcomes of Percutaneous Left Atrial Appendage Closure Versus Direct Oral Anticoagulation in Patients With Atrial Fibrillation.

The availability of direct oral anticoagulants (DOACs) with known lower bleeding risk compared with warfarin have raised questions about the role of left atrial appendage closure (LAAC). We aimed to perform a meta-analysis to compare the clinical outcomes for LAAC versus DOACs. All studies directly comparing LAAC with DOACs up to January 2023 were included. The outcomes studied included the combined major adverse cardiovascular (CV) events outcomes, ischemic stroke and thromboembolic events, major bleeding, CV mortality, and all-cause mortality. Hazard ratios (HRs) and their 95% confidence interval were extracted or estimated from the data and pooled together with a random-effects model. A total of 7 studies (1 randomized controlled trial, 6 propensity-matched observational studies) were finally included, with a pooled population of 4,383 patients who underwent LAAC and 4,554 patients on DOACs. There were no significant differences between patients who underwent LAAC and patients on DOACs in terms of baseline age (75.0 vs 74.7, p = 0.27), CHA2DS2-VASc score (5.1 vs 5.1, p = 0.33), or HAS-BLED score (3.3 vs 3.3, p = 0.36). After a mean weighted follow-up of 22.0 months, LAAC was associated with significantly lower rates of combined major adverse CV event outcomes (HR 0.73 [0.56 to 0.95], p = 0.02), all-cause mortality (HR 0.68 [0.54 to 0.86], p = 0.02), and CV mortality (HR 0.55 [0.41 to 0.72], p<0.01). There were no significant differences in the rates of ischemic stroke or systemic embolism (HR 1.12 [0.92 to 1.35], p = 0.25), major bleeding (HR 0.94 [0.67 to 1.32], p = 0.71), or hemorrhagic stroke (HR 1.07 [0.74 to 1.54], p = 0.74) between LAAC and DOAC. In conclusion, percutaneous LAAC was found to be as efficacious as DOACs for stroke prevention, with lower all-cause and CV mortality. The rates of major bleeding and hemorrhagic stroke were similar. LAAC has a potential role to play in stroke prevention in patients with atrial fibrillation in the era of DOACs, but further randomized data are needed.

Pulmonary Artery Strain Predicts Prognosis in Pulmonary Arterial Hypertension.

BACKGROUND: Current cardiac magnetic resonance (CMR) imaging in pulmonary arterial hypertension (PAH) focuses on measures of ventricular function and coupling. OBJECTIVES: The purpose of this study was to evaluate pulmonary artery (PA) global longitudinal strain (GLS) as a prognostic marker in patients with PAH. METHODS: The authors included 169 patients with PAH from the ASPIRE (Assessing the Spectrum of Pulmonary hypertension Identified at a REferral centre) and INITIATE (Integrated computatioNal modelIng of righT heart mechanIcs and blood flow dynAmics in congeniTal hEart disease) registries, and 82 normal controls with similar age and gender distributions. PA GLS was derived from CMR feature tracking. Right ventricular measurements including volumes, ejection fraction, and right ventricular GLS were also derived from CMR. Patients were followed up a median of 34 months with all-cause mortality as the primary endpoint. Other known risk scores were collected, including the REVEAL (Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension Disease Management) 2.0 and COMPERA (Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension) 2.0 scores. RESULTS: Of 169 patients (mean age: 57 ± 15 years; 80% female), 45 (26.6%) died (median follow-up: 34 months). Mean PA GLS was 23% ± 6% in normal controls and 10% ± 5% in patients with PAH (P < 0.0001). Patients with PA GLS <9% had a higher risk of mortality than those with PA GLS ≥9% (P < 0.001), and this was an independent predictor of mortality in PAH on multivariable analysis after adjustment for known risk factors (HR: 2.93; P = 0.010). Finally, in patients with PAH, PA GLS provided incremental prognostic value over the REVEAL 2.0 (global chi-square; P = 0.001; C statistic comparison; P = 0.030) and COMPERA 2.0 (global chi-square; P = 0.001; C statistic comparison; P = 0.048). CONCLUSIONS: PA GLS confers incremental prognostic utility over the established risk scores for identifying patients with PAH at higher risk of death, who may be targeted for closer monitoring and/or intensified therapy.

Coronary CT Angiography-based Morphologic Index for Predicting Hemodynamically Significant Coronary Stenosis.

Purpose To develop a new coronary CT angiography (CCTA)-based index, α×LL/MLD4, that considers lesion entrance angle (α) in addition to lesion length (LL) and minimal lumen diameter (MLD) and to evaluate its efficacy in predicting hemodynamically significant coronary stenosis compared with invasive coronary angiography (ICA)-derived fractional flow reserve (FFR). Materials and Methods This prospective study enrolled participants (September 2016-March 2020) from two centers who underwent CCTA followed by ICA (ClinicalTrials.gov identifier: NCT03054324). CCTA images were processed semiautomatically to measure LL, MLD, and α for calculating α×LL/MLD4. Diagnostic performance and accuracy of α×LL/MLD4 and LL/MLD4 in detecting hemodynamically significant coronary stenosis were compared against the reference standard (invasive FFR ≤ 0.80). Results In total, 133 participants (mean age, 63 years ± 9 [SD]; 99 [74%] men) with 210 stenosed coronary arteries were analyzed. Median α×LL/MLD4 was 54.0 degree/mm3 (IQR, 25.3-128.7) in participants with invasive FFR of 0.80 or less and 6.7 degree/mm3 (IQR, 3.3-12.8) in participants with invasive FFR of more than 0.80 (P < .001). The per-vessel accuracy, sensitivity, specificity, positive predictive value, and negative predictive value for discriminating ischemic lesions were 86.2%, 83.1%, 88.4%, 84.1%, and 87.7% for α×LL/MLD4 and 80.5%, 66.3%, 90.9%, 84.3%, and 78.6% for LL/MLD4, respectively. Area under the receiver operating characteristic curve for discriminating hemodynamically significant stenosis was 0.93 for α×LL/MLD4, which was significantly greater than the values of 0.84 for LL/MLD4 and 0.63 for diameter stenosis (both P < .001). Conclusion The new morphologic index, α×LL/MLD4, incorporating lesion entrance angle achieved higher diagnostic performance in detecting hemodynamically significant lesions compared with diameter stenosis and LL/MLD4. Keywords: CT Angiography, Cardiac, Coronary Arteries, Ischemia, Infarction, Technology Assessment Clinical trial registration no. NCT03054324 Supplemental material is available for this article. © RSNA, 2023 See also the commentary by Fairbairn and Nørgaard in this issue.

Impact of aortic annular size and valve type on haemodynamics and clinical outcomes after transcatheter aortic valve implantation.

INTRODUCTION: Data on patients with small aortic annuli (SAA) undergoing transcatheter aortic valve implantation (TAVI) are limited. We aim to describe the impact of aortic annular size, particularly SAA and TAVI valve type on valve haemodynamics, durability and clinical outcomes. METHOD: All patients in National Heart Centre Singapore who underwent transfemoral TAVI for severe symptomatic native aortic stenosis from July 2012 to December 2019 were included. Outcome measures include valve haemodynamics, prosthesis-patient mismatch (PPM), structural valve degeneration (SVD) and mortality. RESULTS: A total of 244 patients were included. The mean Society of Thoracic Surgeons score was 6.22±6.08, with 52.5% patients with small aortic annulus (<23mm), 33.2% patients with medium aortic annulus (23-26mm) and 14.3% patients with large aortic annulus (>26mm). There were more patients with self-expanding valve (SEV) (65.2%) versus balloon-expandable valve (BEV) (34.8%). There were no significant differences in indexed aortic valve area (iAVA), mean pressure gradient (MPG), PPM, SVD or mortality across all aortic annular sizes. However, specific to the SAA group, patients with SEV had larger iAVA (SEV 1.19±0.35cm2/m2 vs BEV 0.88±0.15cm2/m2, P<0.01) and lower MPG (SEV 9.25±4.88 mmHg vs BEV 14.17±4.75 mmHg, P<0.01) at 1 year, without differences in PPM or mortality. Aortic annular size, TAVI valve type and PPM did not predict overall mortality up to 7 years. There was no significant difference in SVD between aortic annular sizes up to 5 years. CONCLUSION: Valve haemodynamics and durability were similar across the different aortic annular sizes. In the SAA group, SEV had better haemodynamics than BEV at 1 year, but no differences in PPM or mortality. There were no significant differences in mortality between aortic annular sizes, TAVI valve types or PPM.

Sex differences in assessing stenosis severity between physician visual assessment and quantitative coronary angiography.

BACKGROUND: Physician visual assessment (PVA) in invasive coronary angiography (ICA) is the current clinical method to determine stenosis severity and guide percutaneous coronary intervention. This study sought to evaluate the effect of sex differences in assessing coronary stenosis severity between PVA and quantitative coronary angiography (QCA). METHODS: 209 patients with coronary artery disease (288 coronary lesions) underwent ICA and fractional flow reserve (FFR). ICA image processing including PVA and QCA was used to quantify diameter stenosis (DS). The difference of DS (ΔDS) between PVA and QCA was defined as DSPVA-DSQCA. DS ≥50% was considered anatomically obstructive. FFR ≤0.8 was defined as myocardial ischemia. RESULTS: Mean ± SD age was 63 ± 9 years. There were no significant differences in DSPVA (61.1 ± 16.3% vs 60.1 ± 18.9%) and DSQCA (53.1 ± 12.1% vs 55.4 ± 14.3%) between females and males. However, ΔDS between PVA and QCA was higher in females (8.0 ± 10.9%) than in males (4.7 ± 10.9%) (P = 0.03). Thirty-four of 72 vessels (47.2%) in female patients and 75 of 216 vessels (34.7%) in male patients were classified differently by at least one grade using PVA compared to QCA assessment. DSPVA and DSQCA were negatively correlated with FFR in females (rPVA = -0.397, rQCA = -0.448) with an even stronger negative correlation in males (rPVA = -0.607, rQCA = -0.607). ROC analysis demonstrated that DSQCA had better discrimination capability for myocardial ischemia (FFR ≤ 0.80) than DSPVA in both sexes (P < 0.05). CONCLUSIONS: A systematic bias was found in PVA (QCA reference) for overestimating severity of coronary artery disease in females compared to males.

Sustained Safety and Performance of a Second-Generation Sirolimus-Eluting Absorbable Metal Scaffold: Long-Term Data of the BIOSOLVE-II First-in-Man Trial at 5 Years.

BACKGROUND: Permanent drug-eluting stents are associated with a steady increase in late complications attributed to persistent inflammation and poor vessel remodelling. Bioresorbable scaffolds have been developed to overcome such long-term limitations by providing temporary vessel support and disappearing thereafter. We aimed to assess the long-term outcomes of an absorbable metallic scaffold at 5 years. METHODS: BIOSOLVE-II is an international, multi-centre, first-in-human study assessing the safety and performance of the sirolimus-eluting absorbable metal scaffold DREAMS 2G (commercial name Magmaris) in patients with a maximum of two de novo lesions. After 3 years, follow-up was extended to 5 years with the endpoints of target lesion failure and rate of definite or probable stent thrombosis. RESULTS: A total of 123 patients with 123 lesions were enrolled. Lesions were 12.6 ± 4.5 mm long and 2.7 ± 0.4 mm in diameter, 43.4% were class B2/C lesions, and calcification was moderate to severe in 10.6%. At 5 years, 5.4% of patients had stable angina and 94.6% had no symptoms or ischaemia. Target lesion failure rate was 8.0% [95% confidence interval:4.2;14.9], reflecting 2 cardiac deaths, 2 target-vessel myocardial infarctions, and 6 clinically driven target lesion revascularizations (TLRs). Only one target lesion failure occurred beyond 3 years: a target-vessel myocardial infarction with clinically driven TLR on post-procedure day 1157. One additional non-cardiac death beyond 3 years due to renal failure was reported on day 1777. No definite or probable scaffold thrombosis was observed. CONCLUSION: The Magmaris scaffold showed favourable long-term safety and clinical performance with low target lesion failure rates and absence of definite or probable scaffold thrombosis throughout 5 years.

Diagnostic Performance of Fractional Flow Reserve From CT Coronary Angiography With Analytical Method.

The aim of this study was to evaluate a new analytical method for calculating non-invasive fractional flow reserve (FFRAM) to diagnose ischemic coronary lesions. Patients with suspected or known coronary artery disease (CAD) who underwent computed tomography coronary angiography (CTCA) and invasive coronary angiography (ICA) with FFR measurements from two sites were prospectively recruited. Obstructive CAD was defined as diameter stenosis (DS) ≥50% on CTCA or ICA. FFRAM was derived from CTCA images and anatomical features using analytical method and was compared with computational fluid dynamics (CFD)-based FFR (FFRB) and invasive ICA-based FFR. FFRAM, FFRB, and invasive FFR ≤ 0.80 defined ischemia. A total of 108 participants (mean age 60, range: 30-83 years, 75% men) with 169 stenosed coronary arteries were analyzed. The per-vessel accuracy, sensitivity, specificity, and positive predictive and negative predictive values were, respectively, 81, 75, 86, 81, and 82% for FFRAM and 87, 88, 86, 83, and 90% for FFRB. The area under the receiver operating characteristics curve for FFRAM (0.89 and 0.87) and FFRB (0.90 and 0.86) were higher than both CTCA- and ICA-derived DS (all p < 0.0001) on per-vessel and per-patient bases for discriminating ischemic lesions. The computational time for FFRAM was much shorter than FFRB (2.2 ± 0.9 min vs. 48 ± 36 min, excluding image acquisition and segmentation). FFRAM calculated from a novel and expeditious non-CFD approach possesses a comparable diagnostic performance to CFD-derived FFRB, with a significantly shorter computational time.

Computed Tomography Coronary Angiography and Computational Fluid Dynamics Based Fractional Flow Reserve Before and After Percutaneous Coronary Intervention.

Invasive fractional flow reserve (FFR) is recommended to guide stent deployment. We previously introduced a non-invasive FFR calculation (FFRB) based on computed tomography coronary angiography (CTCA) with reduced-order computational fluid dynamics (CFD) and resistance boundary conditions. Current study aimed to assess the feasibility and accuracy of FFRB for predicting coronary hemodynamics before and after stenting, with invasive FFR as the reference. Twenty-five patients who had undergone CTCA were prospectively enrolled before invasive coronary angiography (ICA) and FFR-guided percutaneous coronary intervention (PCI) on 30 coronary vessels. Using reduced-order CFD with novel boundary conditions on three-dimensional (3D) patient-specific anatomic models reconstructed from CTCA, we calculated FFRB before and after virtual stenting. The latter simulated PCI by clipping stenotic segments from the 3D coronary models and replacing them with segments to mimic the deployed coronary stents. Pre- and post-virtual stenting FFRB were compared with FFR measured pre- and post-PCI by investigators blinded to FFRB results. Among 30 coronary lesions, pre-stenting FFRB (mean 0.69 ± 0.12) and FFR (mean 0.67 ± 0.13) exhibited good correlation (r = 0.86, p < 0.001) and agreement [mean difference 0.024, 95% limits of agreement (LoA): -0.11, 0.15]. Similarly, post-stenting FFRB (mean 0.84 ± 0.10) and FFR (mean 0.86 ± 0.08) exhibited fair correlation (r = 0.50, p < 0.001) and good agreement (mean difference 0.024, 95% LoA: -0.20, 0.16). The accuracy of FFRB for identifying post-stenting ischemic lesions (FFR ≤ 0.8) (residual ischemia) was 87% (sensitivity 80%, specificity 88%). Our novel FFRB, based on CTCA with reduced-order CFD and resistance boundary conditions, accurately predicts the hemodynamic effects of stenting which may serve as a tool in PCI planning.

Modified double guiding catheter 'Ping Pong' technique to treat large coronary perforation: a case report.

BACKGROUND: Despite improvement in available tools and techniques, procedural complications like coronary perforation can occur during percutaneous coronary intervention (PCI). Severe proximal coronary perforations are usually caused by balloon and vessel size mismatch but can also occur with appropriately sized balloons or stents if the coronary vessel has very eccentric calcification or if there is negative remodelling of the vessel. CASE SUMMARY: A 74-year-old man with a history of type II diabetes mellitus, hypertension, and chronic coronary syndrome (previous PCI 10 years before) presented with unstable angina of 2 weeks of duration. Coronary angiography revealed a patent stent in left anterior descending artery, significant disease in left circumflex artery and diffuse calcified lesion in dominant right coronary artery (RCA). During angioplasty of RCA, the patient developed severe Ellis grade III perforation, which was successfully managed with modified double guiding catheter 'Ping Pong' technique. In this technique, the already engaged 7 French (F) Amplatz Left 1 guide catheter was used to deliver the bulky covered stent in highly tortuous and calcified RCA while a second 6F guide catheter (Judkin Right) introduced through contralateral femoral access was used for introducing the balloon, which initially sealed the perforation and subsequently acted as a distal anchor to provide strong support to deliver the covered stent. CONCLUSION: In a case of severe coronary perforation, modified Ping Pong technique using a small-sized second guide catheter complimentary to the first guide catheter, can be used to deploy bulky covered stent.

Real-World Experience of Coronary Intravascular Lithotripsy in an Asian Population: A Retrospective, Observational, Single-Center, All-Comers Registry.

OBJECTIVES: To assess the clinical and angiographic outcomes of coronary intravascular lithotripsy (IVL) use in an all-comers population with moderate-to-severely calcified coronary lesions. BACKGROUND: IVL has been shown to modify coronary calcific plaques with minimal vascular complications. METHODS: This was a retrospective, observational study of patients treated with IVL. The primary endpoint was in-hospital major adverse cardiovascular event (MACE), which included cardiac death, myocardial infarction (MI), and target-vessel revascularization (TVR). Secondary endpoints were clinical success (stent expansion with <30% in-stent residual stenosis and no in-hospital MACE) and angiographic success. RESULTS: Between August 2019 and December 2019, a total of 50 calcified lesions were treated in 45 patients using the Shockwave C2 IVL catheter (Shockwave Medical). They were further studied in 3 treatment subgroups: (1) primary IVL group with de novo lesions (n = 23 lesions); (2) secondary IVL group in which non-compliant balloon dilation failed (n = 15 lesions); and (3) tertiary IVL group with IVL to underexpanded stents (n = 12 lesions). The mean diameter stenosis of calcified lesions was 63.2 ± 10.2% at baseline, and decreased to 33.5 ± 10.9% immediately post IVL (P<.001) and 15 ± 7.1% post stenting (P<.001). Mean minimal lumen diameter was 1.1 ± 0.3 mm at baseline, and increased to 1.90 ± 0.5 mm post IVL (P<.001) and 2.80 ± 0.50 mm post stenting (P<.001). In-hospital and 30-day MACE occurred in 3 and 4 patients, respectively. Overall, clinical success and angiographic success were achieved in 90% and 94% of cases, respectively. CONCLUSIONS: IVL appears to be a safe, effective, and feasible strategy for calcium modification in an all-comers cohort with high success rate, minimal procedural complications, and low MACE rates.

Five-Meter Walk Test as a Predictor of Prolonged Index Hospitalization After Transcatheter Aortic Valve Implantation.

There are no studies evaluating comprehensive predictors of transcatheter aortic valve implantation (TAVI) outcomes encompassing frailty assessments in a South-East Asian cohort. In this longitudinal single-center cohort, all patients who underwent TAVI in a tertiary cardiac center and comprehensively assessed for frailty at baseline were included in a registry. The primary outcome was to investigate frailty indices predictive of prolonged index hospitalization after TAVI. Seventy-six patients with a mean age of 77.6 ± 8.5 years were included. Mean Society of Thoracic Society Predicted Risk of Mortality score was 5.2 ± 3.0, with 11 (14.5%) patients classified as high-risk (Society of Thoracic Society Predicted Risk of Mortality >8). Mean and median index hospitalization duration were 9.2 ± 5.6 and 7 [4.5 to 9.5] days, respectively. Univariate analysis demonstrated that lower hemoglobin (Hb) (p <0.01), longer 5-meter walk test (5MWT) (p <0.01), lower dominant hand grip strength (p <0.01), the use of transaortic access (p = 0.01), new atrial fibrillation post-TAVI (p <0.01), and lower postprocedural Hb (p <0.01) were associated with longer index hospitalization duration. Multivariate linear regression demonstrated preoperative Hb, preoperative atrial fibrillation and 5MWT were independent baseline predictors of index hospitalization duration (p <0.05). Additionally, a 5MWT cutoff of 11 seconds (0.45 m/s) had a high specificity (88.6%) in predicting prolonged index hospitalization duration. In conclusion, this is the first comprehensive frailty assessment in a South-East Asian cohort demonstrating 5MWT to be a significant predictor of prolonged index hospitalization. This simple and effective frailty assessment index may be considered to optimize patient selection for TAVI.

Quantification of effects of mean blood pressure and left ventricular mass on noninvasive fast fractional flow reserve.

Proper inlet boundary conditions are essential for accurate computational fluid dynamics (CFD) modeling. We developed methodology to derive noninvasive FFRB using CFD and computed tomography coronary angiography (CTCA) images. This study aims to assess the influence of brachial mean blood pressure (MBP) and total coronary inflow on FFRB computation. Twenty-two patients underwent both CTCA and FFR measurements. Total coronary flow was computed from left ventricular mass (LVM) measured from CTCA. A total of 286 CFD simulations were run by varying MBP and LVM at 70, 80, 90, 100, 110, 120, and 130% of the measured values. FFRB increased with incrementally higher input values of MBP: 0.78 ± 0.12, 0.80 ± 0.11, 0.82 ± 0.10, 0.84 ± 0.09, 0.85 ± 0.08, 0.86 ± 0.08, and 0.87 ± 0.07, respectively. Conversely, FFRB decreased with incrementally higher inputs value of LVM: 0.86 ± 0.08, 0.85 ± 0.08, 0.84 ± 0.09, 0.84 ± 0.09, 0.83 ± 0.10, 0.83 ± 0.10, and 0.82 ± 0.10, respectively. Noninvasive FFRB calculated using measured MBP and LVM on a total of 30 vessels was 0.84 ± 0.09 and correlated well with invasive FFR (0.83 ± 0.09) (r = 0.92, P < 0.001). Positive association was observed between FFRB and MBP input values (mmHg) and negative association between FFRB and LVM values (g). Respective slopes were 0.0016 and -0.005, respectively, suggesting potential application of FFRB in a clinical setting. Inaccurate MBP and LVM inputs differing from patient-specific values could result in misclassification of borderline ischemic lesions.NEW & NOTEWORTHY While brachial mean blood pressure (MBP) and left ventricular mass (LVM) measured from CTCA are the two CFD simulation input parameters, their effects on noninvasive fractional flow reserve (FFRB) have not been systematically investigated. We demonstrate that inaccurate MBP and LVM inputs differing from patient-specific values could result in misclassification of borderline ischemic lesions. This is important in the clinical application of noninvasive FFR in coronary artery disease diagnosis.

Impact of Chronic Kidney Disease on Outcomes in Transcatheter Aortic Valve Implantation.

INTRODUCTION: Chronic kidney disease (CKD) is a significant comorbidity in aortic stenosis (AS) patients. We examined the impact of baseline CKD, postoperative acute kidney injury (AKI) and CKD progression on clinical outcomes in patients who underwent transcatheter aortic valve implantation (TAVI). MATERIALS AND METHODS: Consecutive patients with severe AS who underwent TAVI were classified into CKD stages 1-2 (≥60 mL/min/1.72m2), 3 (30-59 mL/min/1.73m2) and 4-5 (<30 mL/min/1.73m2 or dialysis) based on estimated glomerular filtration rate (eGFR). Primary outcome was mortality and secondary outcomes included 1-year echocardiographic data on aortic valve area (AVA), mean pressure gradient (MPG) and aortic regurgitation (AR). RESULTS: A total of 216 patients were included. Higher eGFR was associated with lower overall mortality (adjusted hazards ratio [AHR] 0.981, 95% confidence interval [CI] 0.968-0.993, P = 0.002). CKD 4-5 were associated with significantly higher mortality from non-cardiovascular causes (P <0.05). Patients with CKD 3-5 had higher incidence of moderate AR than those with CKD 1-2 (P = 0.010); no difference in AVA and MPG was seen. AKI patients had higher mortality (P = 0.008), but the effect was attenuated on multivariate analysis (AHR 1.823, 95% CI 0.977-3.403, P = 0.059). Patients with CKD progression also had significantly higher mortality (AHR 2.969, 95% CI 1.373-6.420, P = 0.006). CONCLUSION: CKD in severe AS patients undergoing TAVI portends significantly higher mortality and morbidity. Renal disease progression impacts negatively on outcomes and identifies a challenging subgroup of patients for optimal management.