Coronary Physiology Guidance vs Conventional Angiography for Optimization of Percutaneous Coronary Intervention: The AQVA-II Trial.

BACKGROUND: The debate surrounding the efficacy of coronary physiological guidance compared with conventional angiography in achieving optimal post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) values persists. OBJECTIVES: The primary aim of this study was to demonstrate the superiority of physiology-guided PCI, using either angiography or microcatheter-derived FFR, over conventional angiography-based PCI in complex high-risk indicated procedures (CHIPs). The secondary aim was to establish the noninferiority of angiography-derived FFR guidance compared with microcatheter-derived FFR guidance. METHODS: Patients with obstructive coronary lesions and meeting CHIP criteria were randomized 2:1 to receive undergo physiology- or angiography-based PCI. Those assigned to the former were randomly allocated to angiography- or microcatheter-derived FFR guidance. CHIP criteria were long lesion (>28 mm), tandem lesions, severe calcifications, severe tortuosity, true bifurcation, in-stent restenosis, and left main stem disease. The primary outcome was invasive post-PCI FFR value. The optimal post-PCI FFR value was defined as >0.86. RESULTS: A total of 305 patients (331 study vessels) were enrolled in the study (101 undergoing conventional angiography-based PCI and 204 physiology-based PCI). Optimal post-PCI FFR values were more frequent in the physiology-based PCI group compared with the conventional angiography-based PCI group (77% vs 54%; absolute difference 23%, relative difference 30%; P < 0.0001). The occurrence of the primary outcome did not differ between the 2 physiology-based PCI subgroups, demonstrating the noninferiority of angiography- vs microcatheter-derived FFR (P < 0.01). CONCLUSIONS: In CHIP patients, procedural planning and guidance on the basis of physiology (through either angiography- or microcatheter-derived FFR) are superior to conventional angiography for achieving optimal post-PCI FFR values. (Physiology Optimized Versus Angio-Guided PCI [AQVA-II]; NCT05658952).

Minimalistic Hybrid Approach for the Percutaneous Treatment of Coronary Chronic Total Occlusions: Midterm Follow-Up of an International Multicenter Cohort.

The minimalistic hybrid approach (MHA) is a recently proposed algorithm to perform chronic total occlusion (CTO) percutaneous coronary intervention (PCI), reducing the overall invasiveness of the procedure without impacting the acute results. However, data on midterm results are lacking. This study aimed to evaluate the midterm clinical outcomes of a multicenter international cohort of CTO PCI treated according to the MHA. Data from a consecutive series of patients with a CTO who underwent PCI according to the MHA between February 2019 and March 2022 were prospectively collected in 3 European centers and retrospectively analyzed. The main outcome was the first occurrence of a major adverse cardiac event (MACE), defined as a composite outcome of all-cause death, any myocardial infarction, and target vessel revascularization, at the last follow-up available. A total of 212 patients were included. The majority of the patients were symptomatic for angina (Canadian Cardiovascular Society class 2 or 3: 63.7%) at the time of the index procedure. The mean Japanese-CTO and CASTLE scores were 2.1 ± 1.2 and 2.0 ± 1.3, respectively. Technical success (CTO open with optimal flow) was achieved in 198 patients (93.9%) and procedural success (technical success without in-hospital MACEs) in 195 (91.9%). At the last follow-up available (median 677 days), the cumulative incidence rate of MACEs was 11.5%; in particular, all-cause death was 7.4%, any myocardial infarction was 4.3%, and unplanned target vessel revascularization was 6.5%. In conclusion, the midterm results of the MHA seem to be in line with contemporary results of other CTO PCI algorithms, thus potentially validating the MHA as a valuable alternative, provided that interventionalists are already expert CTO operators and accustomed to the definitions and peculiarities of MHA.

"Safe Femoral" Artery Approach in Endovascular Procedures: A Systematic Review of Its Safety and Feasibility.

Femoral access site-related bleeding represent a prognostically impactful issue in interventional cardiology. The impact of a combined use of ultrasound guidance for femoral access and vascular closure device deployment for arteriotomy closure in femoral artery procedures on bleeding complications is still largely unknown. A systematic review was conducted on Pubmed (Medline), Cochrane library and Biomed Central databases between March and April 2023. A total of 9 studies have been selected, of namely 4 registries, 4 prospective studies and one randomized clinical trial. A systematic use of US guidance to access femoral artery resulted feasible and not time consuming, reduced venipuncture and increased first attempt success. Combination of US guidance and deployment of VCD's had the capacity to further decrease vascular and bleeding combination, especially in those patients at a higher risk of post-procedural bleeding. Ultrasound can be easily used during closure device deployment to reduce device failure and major vascular complications.

Wire-based antegrade dissection re-entry technique for coronary chronic total occlusions percutaneous revascularization: Experience from the ERCTO Registry.

BACKGROUND: The recent development and widespread adoption of antegrade dissection re-entry (ADR) techniques have been underlined as one of the antegrade strategies in all worldwide CTO consensus documents. However, historical wire-based ADR experience has suffered from disappointing long-term outcomes. AIMS: Compare technical success, procedural success, and long-term outcome of patients who underwent wire-based ADR technique versus antegrade wiring (AW). METHODS: One thousand seven hundred and ten patients, from the prospective European Registry of Chronic Total Occlusions (ERCTO), underwent 1806 CTO procedures between January 2018 and December 2021, at 13 high-volume ADR centers. Among all 1806 lesions attempted by the antegrade approach, 72% were approached with AW techniques and 28% with wire-based ADR techniques. RESULTS: Technical and procedural success rates were lower in wire-based ADR than in AW (90.3% vs. 96.4%, p < 0.001; 87.7% vs. 95.4%, p < 0.001, respectively); however, wire-based ADR was used successfully more often in complex lesions as compared to AW (p = 0.017). Wire-based ADR was used in most cases (85%) after failure of AW or retrograde procedures. At a mean clinical follow-up of 21 ± 15 months, major adverse cardiac and cerebrovascular events (MACCEs) did not differ between AW and wire-based ADR (12% vs. 15.1%, p = 0.106); both AW and wire-based ADR procedures were associated with significant symptom improvements. CONCLUSIONS: As compared to AW, wire-based ADR is a reliable and effective strategy successfully used in more complex lesions and often after the failure of other techniques. At long-term follow-up, patient's MACCEs and symptoms improvement were similar in both antegrade techniques.

Complete or Culprit-Only PCI in Older Patients with Myocardial Infarction.

BACKGROUND: The benefit of complete revascularization in older patients (≥75 years of age) with myocardial infarction and multivessel disease remains unclear. METHODS: In this multicenter, randomized trial, we assigned older patients with myocardial infarction and multivessel disease who were undergoing percutaneous coronary intervention (PCI) of the culprit lesion to receive either physiology-guided complete revascularization of nonculprit lesions or to receive no further revascularization. Functionally significant nonculprit lesions were identified either by pressure wire or angiography. The primary outcome was a composite of death, myocardial infarction, stroke, or any revascularization at 1 year. The key secondary outcome was a composite of cardiovascular death or myocardial infarction. Safety was assessed as a composite of contrast-associated acute kidney injury, stroke, or bleeding. RESULTS: A total of 1445 patients underwent randomization (720 to receive complete revascularization and 725 to receive culprit-only revascularization). The median age of the patients was 80 years (interquartile range, 77 to 84); 528 patients (36.5%) were women, and 509 (35.2%) were admitted for ST-segment elevation myocardial infarction. A primary-outcome event occurred in 113 patients (15.7%) in the complete-revascularization group and in 152 patients (21.0%) in the culprit-only group (hazard ratio, 0.73; 95% confidence interval [CI], 0.57 to 0.93; P = 0.01). Cardiovascular death or myocardial infarction occurred in 64 patients (8.9%) in the complete-revascularization group and in 98 patients (13.5%) in the culprit-only group (hazard ratio, 0.64; 95% CI, 0.47 to 0.88). The safety outcome did not appear to differ between the groups (22.5% vs. 20.4%; P = 0.37). CONCLUSIONS: Among patients who were 75 years of age or older with myocardial infarction and multivessel disease, those who underwent physiology-guided complete revascularization had a lower risk of a composite of death, myocardial infarction, stroke, or ischemia-driven revascularization at 1 year than those who received culprit-lesion-only PCI. (Funded by Consorzio Futuro in Ricerca and others; FIRE ClinicalTrials.gov number, NCT03772743.).

QFR-Based Virtual PCI or Conventional Angiography to Guide PCI: The AQVA Trial.

BACKGROUND: Post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) values ≥0.90 are associated with a low incidence of adverse events. OBJECTIVES: The AQVA (Angio-based Quantitative Flow Ratio Virtual PCI Versus Conventional Angio-guided PCI in the Achievement of an Optimal Post-PCI QFR) trial aims to test whether a QFR-based virtual percutaneous coronary intervention (PCI) is superior to a conventional angiography-based PCI at obtaining optimal post-PCI QFR results. METHODS: The AQVA trial is an investigator-initiated, randomized, controlled, parallel-group clinical trial. A total of 300 patients (356 study vessels) undergoing PCI were randomized 1:1 to receive either QFR-based virtual PCI or angiography-based PCI (standard of care). The primary outcome was the rate of study vessels with a suboptimal post-PCI QFR value, which was defined as <0.90. Secondary outcomes were procedure duration, stent length/lesion, and stent number/patient. RESULTS: Overall, 38 (10.7%) study vessels missed the prespecified optimal post-PCI QFR target. The primary outcome occurred significantly more frequently in the angiography-based group (n = 26, 15.1%) compared with the QFR-based virtual PCI group (n = 12 [6.6%]; absolute difference = 8.5%; relative difference = 57%; P = 0.009). The main cause of a suboptimal result in the angiography-based group is the underestimation of a diseased segment outside the stented one. There were no significant differences among secondary endpoints, although stent length/lesion and stent number/patient were numerically lower in the virtual PCI group (P = 0.06 and P = 0.08, respectively), whereas procedure length was higher in the virtual PCI group (P = 0.06). CONCLUSIONS: The AQVA trial demonstrated the superiority of QFR-based virtual PCI over angiography-based PCI with regard to post-PCI optimal physiological results. Future larger randomized clinical trials that demonstrate the superiority of this approach in terms of clinical outcomes are warranted. (Angio-based Quantitative Flow Ratio Virtual PCI Versus Conventional Angio-guided PCI in the Achievement of an Optimal Post-PCI QFR [AQVA]; NCT04664140).

Neural interfaces to monitor Interventional Cardiologists' mental workload: GAME-ON SAGA.

BACKGROUND: Interventional cardiologists' mental workload may impact on their performance as well as on patients' outcome. Nevertheless, little attention is paid to the monitoring and optimization of their mental status. Electroencephalogram (EEG)-based neural-interfaces can estimate mental fatigue and sleepiness through spectral analysis techniques and the amplitude of alpha waves is a widely validated indicator of mental engagement's level. METHODS: The present study aims to describe mental fatigue and sleepiness through variation of psychometrics and neurometrics during a work shift in a population of 7 interventional cardiologists. Neurometrics have been acquired at the beginning of the shift, before and after each procedure performed during 127 valid Alpha Attenuation Protocols (AAP), a practical test to quantify sleepiness measuring alpha power during 2 cycle of eye opening/closing protocol. We collected alpha waves' power measures obtained during resting condition (AA Coefficient-eyes open [AAC-eo], AAC-eyes closed [AAC-ec] and AAC-mean), related to fatigue, and AAC-ec/AAC-eo (AAC-ratio), related to sleepiness. RESULTS: From a two-months observation, the first interesting preliminary results emerged: 1) AAC-mean showed an upward trend during the working day, reflecting an increase in mental fatigue (P=0.01); 2) population-level psychometrics trend confirms the same tendency described by neurometrics, possibly reflecting a reduced awareness of the operator of his/her actual mental status. CONCLUSIONS: Developing a low cost and high feasibility device to monitor and analyze operator's mental engagement level could be extremely appealing, considering the lack of data in literature for interventional disciplines and recent technology developments.

Impact of trans-stent gradient on outcome after PCI: results from a HAWKEYE substudy.

To test whether quantitative flow ratio (QFR)-based trans-stent gradient (TSG) is associated with adverse clinical events at follow-up. A post-hoc analysis of the multi-center HAWKEYE study was performed. Vessels post-PCI were divided into four groups (G) as follows: G1: QFR ≥ 0.90 TSG = 0 (n = 412, 54.8%); G2: QFR ≥ 0.90, TSG > 0 (n = 216, 28.7%); G3: QFR < 0.90, TSG = 0 (n = 37, 4.9%); G4: QFR < 0.90, TSG > 0 (n = 86, 11.4%). Cox proportional hazards regression model was used to analyze the effect of baseline and prognostic variables. The final reduced model was obtained by backward stepwise variable selection. Receiver operating characteristic (ROC) was plotted and area under the curve (AUC) was calculated and reported. Overall, 449 (59.8%) vessels had a TSG = 0 whereas (40.2%) had TSG > 0. Ten (2.2%) vessel-oriented composite endpoint (VOCE) occurred in vessels with TSG = 0, compared with 43 (14%) in vessels with TSG > 0 (p < 0.01). ROC analysis showed an AUC of 0.74 (95% CI: 0.67 to 0.80; p < 0.001). TSG > 0 was an independent predictor of the VOCE (HR 2.95 [95% CI 1.77-4.91]). The combination of higher TSG and lower final QFR (G4) showed the worst long-term outcome while low TSG and high QFR showed the best outcome (G1) while either high TSG or low QFR (G2, G3) showed intermediate and comparable outcomes. Higher trans-stent gradient was an independent predictor of adverse events and identified a subgroup of patients at higher risk for poor outcomes even when vessel QFR was optimal (> 0.90).

Coronary access following ACURATE neo implantation for transcatheter aortic valve-in-valve implantation: Ex vivo analysis in patient-specific anatomies.

Background: Coronary access after transcatheter aortic valve implantation (TAVI) with supra-annular self-expandable valves may be challenging or un-feasible. There is little data concerning coronary access following transcatheter aortic valve-in-valve implantation (ViV-TAVI) for degenerated surgical bioprosthesis. Aims: To evaluate the feasibility and challenge of coronary access after ViV-TAVI with the supra-annular self-expandable ACURATE neo valve. Materials and methods: Sixteen patients underwent ViV-TAVI with the ACURATE neo valve. Post-procedural computed tomography (CT) was used to create 3D-printed life-sized patient-specific models for bench-testing of coronary cannulation. Primary endpoint was feasibility of diagnostic angiography and PCI. Secondary endpoints included incidence of challenging cannulation for both diagnostic catheters (DC) and guiding catheters (GC). The association between challenging cannulations with aortic and transcatheter/surgical valve geometry was evaluated using pre and post-procedural CT scans. Results: Diagnostic angiography and PCI were feasible for 97 and 95% of models respectively. All non-feasible procedures occurred in ostia that underwent prophylactic "chimney" stenting. DC cannulation was challenging in 17% of models and was associated with a narrower SoV width (30 vs. 35 mm, p < 0.01), STJ width (28 vs. 32 mm, p < 0.05) and shorter STJ height (15 vs. 17 mm, p < 0.05). GC cannulation was challenging in 23% of models and was associated with narrower STJ width (28 vs. 32 mm, p < 0.05), smaller transcatheter-to-coronary distance (5 vs. 9.2 mm, p < 0.05) and a worse coronary-commissural overlap angle (14.3° vs. 25.6 o , p < 0.01). Advanced techniques to achieve GC cannulation were required in 22/64 (34%) of cases. Conclusion: In this exploratory bench analysis, diagnostic angiography and PCI was feasible in almost all cases following ViV-TAVI with the ACURATE neo valve. Prophylactic coronary stenting, higher implantation, narrower aortic sinus dimensions and commissural misalignment were associated with an increased challenge of coronary cannulation.

Radial vs Femoral Access in ACS Patients Undergoing Complex PCI Is Associated With Consistent Bleeding Benefit and No Excess of Risks.

BACKGROUND: The comparative effectiveness of transradial (TRA) compared with transfemoral (TFA) access in acute coronary syndrome (ACS) patients undergoing complex percutaneous coronary intervention (PCI) remains unclear. METHODS: Among 8404 ACS patients in the Minimising Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX (MATRIX)-Access trial, 5233 underwent noncomplex (TRA: n = 2590; TFA: n = 2643) and 1491 complex (TRA: n = 777; TFA: n = 714) PCI. Co-primary outcomes were major adverse cardiovascular events (MACE, the composite of all-cause mortality, myocardial infarction, or stroke) and the composite of MACE and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding (net adverse cardiovascular events [NACE]) at 30 days. RESULTS: Rates of 30-day MACE (HR 0.94, 95% CI 0.72-1.22) or NACE (HR 0.89, 95% CI 0.69-1.14) did not significantly differ between groups in the complex PCI group, whereas both primary end points were lower (HR 0.84, 95% CI 0.70-1.00; HR 0.83, 95% CI 0.70-0.98; respectively) with TRA among noncomplex PCI patients, with negative interaction testing (Pint = 0.473 and 0.666, respectively). Access-site BARC type 3 or 5 bleeding was lower with TRA, consistently among complex (HR 0.18, 95% CI 0.05-0.63) and noncomplex (HR 0.41, 95% CI 0.20-0.85) PCI patients, whereas the former group had a greater absolute risk reduction of 1.7% (number needed to treat: 59) owing to their higher absolute risk. CONCLUSIONS: Among ACS patients, PCI complexity did not affect the comparative efficacy and safety of TRA vs TFA, whereas the absolute risk reduction of access-site major bleeding was greater with TRA compared with TFA in complex as opposed to noncomplex PCI.

PRECISE-DAPT score for bleeding risk prediction in patients on dual or single antiplatelet regimens: insights from the GLOBAL LEADERS and GLASSY.

AIMS: The five-item PRECISE-DAPT, integrating age, haemoglobin, white-blood-cell count, creatinine clearance, and prior bleeding, predicts bleeding risk in patients on dual antiplatelet therapy (DAPT) after stent implantation. We sought to assess whether the bleeding risk prediction offered by the PRECISE-DAPT remains valid among patients receiving ticagrelor monotherapy from 1 month onwards after coronary stenting instead of standard DAPT and having or not having centrally adjudicated bleeding endpoints. METHODS AND RESULTS: The PRECISE-DAPT was calculated in 14 928 and 7134 patients from GLOBAL LEADERS and GLASSY trials, respectively. The ability of the score to predict Bleeding Academic Research Consortium 3 or 5 bleeding was assessed and compared among patients on ticagrelor monotherapy (experimental strategy) or standard DAPT (reference strategy) from 1 month after drug-eluting stent implantation. Bleeding endpoints were investigator-reported or centrally adjudicated in GLOBAL LEADERS and GLASSY, respectively. At 2 years, the c-indexes for the score among patients treated with the experimental or reference strategy were 0.67 [95% confidence interval (CI): 0.63-0.71] vs. 0.63 (95% CI: 0.59-0.67) in GLOBAL LEADERS (P = 0.27), and 0.67 (95% CI: 0.61-0.73) vs. 0.66 (95% CI: 0.61-0.72) in GLASSY (P = 0.88). Decision curve analysis showed net benefit using the PRECISE-DAPT to guide bleeding risk assessment under both treatment strategies. Results were consistent between investigator-reported and adjudicated endpoints and using the simplified four-item PRECISE-DAPT. CONCLUSION: The PRECISE-DAPT offers a prediction model that proved similarly effective to predict clinically relevant bleeding among patients on ticagrelor monotherapy from 1 month after coronary stenting compared with standard DAPT and appears to be unaffected by the presence or absence of adjudicated bleeding endpoints.

Comparison of Investigator-Reported and Clinical Event Committee-Adjudicated Outcome Events in GLASSY.

BACKGROUND: Event adjudication by a clinical event committee (CEC) provides a standardized, independent outcome assessment. However, the added value of CEC to investigators reporting remains debated. GLASSY (GLOBAL LEADERS Adjudication Sub-Study) implemented, in a subset of the open-label, investigator-reported (IR) GLOBAL LEADERS trial, an independent adjudication process of reported and unreported potential outcome events (triggers). We describe metrics of GLASSY feasibility and efficiency, diagnostic accuracy of IR events, and their concordance with corresponding CEC-adjudicated events. METHODS: We report the proportion of myocardial infarction, bleeding, stroke, and stent thrombosis triggers with sufficient evidence for assessment (feasibility) that were adjudicated as outcome events (efficiency), stratified by source (IR or non-IR). Using CEC-adjudicated events as criterion standard, we describe sensitivity, specificity, positive and negative predictive value, and global diagnostic accuracy of IR events. Using Gwet AC coefficient, we examine the concordance between IR- and corresponding CEC-adjudicated triggers. There was sufficient evidence for assessment for 2592 (98.3%) of 2636 triggers. RESULTS: Overall, the adjudicated end point-to-trigger ratio was high and similar between IR- (88%) and non-IR-reported (87%) triggers. The global diagnostic accuracy and concordance between IR-reported and CEC-adjudicated outcome events was 0.70 (95% CI, 0.65-0.74) and 0.54 (95% CI, 0.45-0.62), respectively, for myocardial infarction; 0.77 (95% CI, 0.75-0.79) and 0.71 (95% CI, 0.68-0.74) for bleeding; 0.70 (95% CI, 0.62-0.79) and 0.59 (95% CI, 0.43-0.74) for stroke; 0.59 (95% CI, 0.52-0.66) and 0.39 (95% CI, 0.25-0.53) for stent thrombosis. For IR bleedings, the concordance with the CEC on type of events was generally weak. CONCLUSIONS: Implementing CEC adjudication in a pragmatic open-label trial with IR events is feasible and efficient. Our findings of modest global diagnostic accuracy for IR events and generally weak concordance between investigators and CEC support the role for CEC adjudication in such settings. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03231059.

Safety, efficacy and impact on frailty of mini-invasive radial balloon aortic valvuloplasty.

OBJECTIVE: The study was designed to: (1) confirm safety and feasibility of mini-invasive radial balloon aortic valvuloplasty (BAV); (2) assess its impact in terms of quality of life and frailty; and (3) evaluate whether changes in frailty after BAV are associated with death in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: 330 patients undergoing BAV in 16 Italian centres were prospectively included. The primary endpoint was the occurrence of major and minor Valve Academic Research Consortium (VARC)-2 bleeding. Secondary endpoints were scales of quality of life, frailty, evaluated at baseline and 30 days, and their relationship with the occurrence of all-cause death. RESULTS: BAV was performed by radial access in 314 (95%) patients. No VARC-2 major and six (1.8%) VARC-2 minor bleedings occurred in the study population. Quality of life, as well as frailty status, significantly improved 30 days after BAV. At 1 year, patients undergoing TAVI with baseline essential frailty toolset (EFT) <3 or achieving an EFT <3 after BAV had a comparable occurrence of all-cause death (15% vs 19%, p=0.58). On the contrary, patients with EFT ≥3 at 30 days despite BAV showed the worst prognosis (all-cause death: 40% vs 15% and 19%, p=0.006 and p=0.05, respectively). CONCLUSIONS: Mini-invasive radial BAV is safe, feasible and associated with a low rate of vascular complications. Patients improving EFT 30 days after BAV showed a favourable outcome after TAVI. TRIAL REGISTRATION NUMBER: NCT03087552.

Contemporary balloon aortic valvuloplasty: Changing indications and refined technique.

Even if un to improve long-term prognosis, balloon aortic valvuloplasty (BAV) may be useful in selected patients with symptomatic severe aortic stenosis either as a bridge to surgical or transcatheter valve replacement (aortic valve replacement [AVR] or transcatheter aortic valve implantation [TAVI]) or as a triage strategy for patients with uncertain indications. International guidelines recommend BAV as: a "bridge" to AVR/TAVI, a "trial" in patients with undetermined symptoms, or a "bridge-to-decision" in case of comorbidities. However, in clinical practice, BAV is also used as a palliative measure to improve hemodynamics and quality of life in many patients who are excluded from AVR/TAVI. Finally, BAV is often performed during TAVI to facilitate prosthesis delivery, optimize frame expansion, or for bioprosthetic valve fracture in selected valve-in-valve procedures. Technical innovations, which allow for a mini-invasive approach via transradial access and pacing delivered through the wire, have led to a decrease in complications over time. This review focuses on contemporary BAV with a specific emphasis on new indications, innovative techniques, and specific complex patient subgroups.

Comparison of quantitative flow ratio, Pd/Pa and diastolic hyperemia-free ratio versus fractional flow reserve in non-culprit lesion of patients with non ST-segment elevation myocardial infarction.

OBJECTIVES: To investigate the correlation between quantitative flow ratio (QFR), Pd/Pa, diastolic hyperemia-free ratio (DFR) and fractional flow reserve (FFR, gold standard) in non-culprit lesion (NCL) of patients with non ST-segment elevation myocardial infarction (NSTEMI). BACKGROUND: The non-hyperemic pressure ratio (NHPR) and the angiography-based indexes have been developed to overcome the limitation of the use of the FFR. METHODS: Between January and December 2019, 184 NCL from 116 NSTEMI patients underwent physiologic assessment and were included in the study. NCLs were investigated with QFR, Pd/Pa, DFR, and FFR. Mean values of QFR, Pd/Pa, DFR and FFR were 0.85 ± 0.10, 0.92 ± 0.07, 0.93 ± 0.05 and 0.84 ± 0.07, respectively. RESULTS: DFR and FFR showed a good correlation (r = 0.76). Bland and Altman plot showed a mean difference of 0.080. DFR Diagnostic accuracy was 88%. The area under the ROC curve (AUC) for DFR was 0.946 (95%CI 0.90-0.97, p = .0001). Similar findings were reported for Pd/Pa (r = 0.73; mean difference 0.095, diagnostic accuracy 84%, AUC 0.909 [95%CI 0.85-0.94, p = .0001]) and QFR (r = 0.68; mean difference 0.01; diagnostic accuracy 88%, AUC 0.964 [95% CI 0.91-0.98, p = .0001]). FFR, QFR, Pd/Pa and DFR identified 31%, 32%, 30% and 32% potentially flow-limiting lesions, respectively. CONCLUSIONS: In NSTEMI patients, QFR, Pd/Pa and DFR showed equivalence as compared to gold standard FFR in the discrimination of non-culprit lesions requiring revascularization.

Efficacy and safety of intracoronary epinephrine versus conventional treatments alone in STEMI patients with refractory coronary no-reflow during primary PCI: The RESTORE observational study.

OBJECTIVES: We aimed to compare intracoronary (IC) epinephrine versus conventional treatments alone in patients with ST-elevation myocardial infarction and refractory coronary no-reflow during primary percutaneous coronary intervention (PPCI). METHODS: Thirty consecutive patients with severe refractory coronary no-reflow (TIMI 0-1, MBG 0-1) during PPCI were prospectively included after initial failure of conventional treatments. Conventional treatments used in both groups included IC nitrates, thrombectomy. Glycoprotein IIb/IIIa inhibitors and adenosine. Patients received IC epinephrine or no epinephrine. RESULTS: Intracoronary administration of epinephrine yielded significantly better coronary flow patterns (28.6% TIMI 3, 64.3% TIMI 2, 7.1% TIMI 1, and 0% TIMI 0), compared to those after treatment with conventional agents alone (18.8% TIMI 3, 12.5% TIMI 2, 37.5% TIMI 1, and 31.3% TIMI 0) (p value between groups = .004). In the IC epinephrine vs. no epinephrine group there was a significant reduction of 30-day composite of death or heart failure (35.7% vs. 81.25%), improvement of ejection fraction (p = .01) and ST-segment resolution (p = .01). CONCLUSIONS: The findings of this proof-of-concept study suggest that as compared to use of conventional agents alone, IC epinephrine provides substantial improvement of coronary flow in STEMI patients with refractory no-reflow during PPCI that may result into improved prognosis.

Snuffbox approach for balloon aortic valvuloplasty: A case series.

In the era of transcatheter aortic valve replacement (TAVR), the spectrum of indications for balloon aortic valvuloplasty is growing, especially in old and frail patients. Mini-invasive approaches via radial access reduce vascular complications and length of hospital stay. The snuffbox approach has never been described for Balloon aortic valvuloplasty (BAV). We performed a review of patients who underwent BAV using distal radial access between January 2019 and December 2019 in a single Italian Centre. All patients received a 30-day follow-up. The procedure was successfully conducted by anatomical snuffbox in all reported cases. All patients were mobilized within 10 h from the procedure without vascular access-related complications. Thirty-day color Doppler ultrasound showed distal radial artery patency in 89% of cases. In our case series, the snuffbox approach for balloon aortic valvuloplasty appeared to be safe and feasible. This approach could be a valid alternative especially in old and frail adults waiting for TAVR.

Acute myocardial infarction and large coronary thrombosis in a patient with COVID-19.

This is a case report of a 60-year-old male, without any cardiovascular risk factor and no cardiac history admitted to hospital with a diagnosis of interstitial pneumonia caused by coronavirus disease 2019 (COVID-19). After 7 days, the blood tests showed a significant rise of inflammatory and procoagulant markers, along with a relevant elevation of high-sensitivity Troponin I. Electrocardiogram and transthoracic echocardiogram (TTE) were consistent with a diagnosis of infero-posterolateral acute myocardial infarction and the patient was transferred to the isolated Cath Lab for primary percutaneous coronary intervention (PCI). The angiography showed an acute massive thrombosis of a dominant right coronary artery without clear evidence of atherosclerosis. Despite the optimal pharmacological therapies and different PCI techniques, the final TIMI flow was 0/1 and after 3 hr the clinical condition evolved in cardiac arrest for pulseless electric activity. Acute coronary syndrome-ST-elevation myocardial infarction is a relevant complication of COVID-19. Due to high levels of proinflammatory mediators, diffuse coronary thrombosis could occur even in patients without cardiac history or comorbidities. This clinical case suggests that coronary thrombosis in COVID-19 patients may be unresponsive to optimal pharmacological (GP IIb-IIIa infusion) and mechanical treatment (PCI).

Angio-Based Index of Microcirculatory Resistance for the Assessment of the Coronary Resistance: A Proof of Concept Study.

BACKGROUND: The study of coronary microcirculation has gained increasing consideration and importance in cath lab. Despite the increase of evidence, its use still remains very limited. QFR is a novel angio-based approach for the evaluation of coronary stenosis. The aim of our study was to use the QFR assessment in stable patients to recreate the IMR formula and to correlate the result of the two techniques. METHODS: From June 1, 2019, to February 29, 2019, 200 patients with CCS and indication of coronary artery angiography and referred to the cath lab of the University Hospital of Ferrara (Italy) were enrolled. After baseline coronary angiogram, quantitative flow ratio, fractional flow reserve, and index of microcirculatory resistance evaluation were performed. RESULTS: Pearson correlation (r) between angio-based index of microcirculatory resistance (A-IMR) and IMR 0.32 with R 2 = 0.098, P=0.03: McNemar test showed a difference between the two tests of 6.82% with 95% CI from -12.05% to 22.89%, which is not significant (P=0.60). Bland and Altman plot showed a mean difference of 23.3 (from -26.5 to 73.1). Sensitivity, specificity, NPV, and PPV were 70%, 83.3%, 75%, and 70% for A-IMR value >44.2. The area under the ROC curve for A-IMR was 0.76 (95% CI 0.61-0.88, P=0.0003). CONCLUSION: We have validated for the first time the formula of the A-IMR, a tool for the calculation of microvascular resistance which does not require the use of pressure guides and the induction of hyperemia.