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1.
Future Cardiol ; 2024 May 03.
Article En | MEDLINE | ID: mdl-38699964

Introduction: Cardiac magnetic resonance imaging (CMR) is vital, but claustrophobia affects 10% of patients. The metaverse, an immersive virtual and augmented reality environment, has healthcare potential. We present a metaverse-based CMR simulation for claustrophobic patients. Methods: Three cardiomyopathy patients, initially CMR-refusing due to claustrophobia, received training via a virtual reality headset in a metaverse-based virtual hospital. Training efficacy was assessed through questionnaires and anxiety scales. Results: The patients successfully completed metaverse-based training, adapting to the CMR simulation. On CMR day, all entered the machine without issues and with reduced anxiety. Patients found the training useful, suggesting platform familiarization. Discussion: Our study demonstrates the metaverse's potential in alleviating CMR-related claustrophobia. The immersive nature enhances patient preparation, although usability improvements are needed. Further research should compare this approach with alternatives.


Cardiac magnetic resonance imaging (CMR) is a vital tool for diagnosing heart problems, but some patients cannot undergo it due to claustrophobia. To address this, researchers are exploring new methods like hypnosis and simulations. One emerging technology, the metaverse, a 3D virtual reality (VR) environment, is being tested in healthcare. This study created a metaverse-based simulation to help claustrophobic patients prepare for CMR. Three patients with heart issues were given VR headsets to access a virtual hospital in the metaverse. Inside, they were trained for CMR step by step, experiencing the process and sounds realistically. Training was done 1 week, 3 days, and 1 day before the real CMR. Anxiety levels were measured. All patients completed the virtual training without issues. During the first simulations, some could not complete entering the virtual CMR machine due to anxiety. However, by the final simulation, all succeeded. On CMR day, all completed the scan without problems, and their anxiety levels decreased significantly from the initial training. Patients found the training helpful, but the platform's usability needed improvement. The study demonstrates that metaverse-based simulations can help patients overcome claustrophobia to successfully undergo CMR. This technology holds promise for simulating medical situations, easing patient fears, and improving preparation. However, further work is needed to make it user-friendly and accessible without assistance. This study encourages more research to assess the usefulness of the metaverse for broader patient groups, comparing it with other methods like hypnosis or sedation.

2.
Circulation ; 2024 May 14.
Article En | MEDLINE | ID: mdl-38742491

BACKGROUND: Diffuse coronary artery disease (CAD) impacts the safety and efficacy of percutaneous coronary intervention (PCI). Pathophysiological CAD patterns can be quantified using fractional flow reserve (FFR) pullbacks incorporating the pullback pressure gradient (PPG) calculation. This study aimed to establish the capacity of PPG to predict optimal revascularisation and procedural outcomes. METHODS: This prospective, investigator-initiated, single-arm, multicentre study enrolled patients with at least one epicardial lesion with an FFR ≤ 0.80 scheduled for PCI. Manual FFR pullbacks were employed to calculate PPG. The primary outcome of optimal revascularisation was defined as a post-PCI FFR ≥ 0.88. RESULTS: 993 patients with 1044 vessels were included. The mean FFR was 0.68 ± 0.12, PPG 0.62 ± 0.17, and post-PCI FFR 0.87 ± 0.07. PPG was significantly correlated with the change in FFR after PCI (r=0.65, 95% CI 0.61-0.69, p<0.001) and demonstrated excellent predicted capacity for optimal revascularisation (AUC 0.82, 95% CI 0.79-0.84, p<0.001). Conversely, FFR alone did not predict revascularisation outcomes (AUC 0.54, 95% CI 0.50-0.57). PPG influenced treatment decisions in 14% of patients, redirecting them from PCI to alternative treatment modalities. Periprocedural myocardial infarction occurred more frequently in patients with low PPG (<0.62) compared to those with focal disease (OR 1.71, 95% CI: 1.00-2.97). CONCLUSIONS: Pathophysiological CAD patterns distinctly affect the safety and effectiveness of PCI. The PPG showed an excellent predictive capacity for optimal revascularisation and demonstrated added value compared to a FFR measurement.

3.
J Cardiothorac Surg ; 19(1): 196, 2024 Apr 10.
Article En | MEDLINE | ID: mdl-38600556

BACKGROUND: The transcarotid (TC) vascular access for transcatheter aortic valve implantation (TAVI) has emerged as the first-choice alternative to the transfemoral access, in patients unsuitable for the latter. The use of both the left and right common carotid arteries (CCAs) for TC-TAVI has been described, but the optimal side is subject to debate. We conducted this pilot study to compare the level of vessel tortuosity and plaque burden from either the left CCA to the aortic annulus, or the right CCA to the aortic annulus, considering them as surrogates for technical and procedural complexity. METHODS: Consecutive patients who underwent TC-TAVI between 2018 and 2021 in our institution were included. Using three-dimensional reconstruction, pre-TAVI neck and chest computed tomography angiography exams were reviewed to assess the tortuosity index (TI), sum of angles metric, as well as plaque burden, between each CCA and the aortic annulus. RESULTS: We included 46 patients who underwent TC-TAVI. No significant difference regarding the mean TIs between the left and right sides (respectively 1.20 and 1.19, p = 0.82), the mean sum of angles (left side: 396°, right side: 384°, p = 0.27), and arterial plaque burden (arterial plaque found in 30% of left CCAs and 45% of right CCAs, p = 0.19) was found. CONCLUSIONS: We found no convincing data favoring the use of one particular access side over the other one. The choice of the CCA side in TC-TAVI should to be made on a case-by-case basis, in a multidisciplinary fashion, and may also depend on the operators' experience.


Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methods , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/etiology , Pilot Projects , Carotid Artery, Common/surgery , Treatment Outcome
4.
EuroIntervention ; 20(8): e496-e503, 2024 Apr 15.
Article En | MEDLINE | ID: mdl-38629422

BACKGROUND: Multidisciplinary Heart Teams (HTs) play a central role in the management of valvular heart diseases. However, the comprehensive evaluation of patients' data can be hindered by logistical challenges, which in turn may affect the care they receive. AIMS: This study aimed to explore the ability of artificial intelligence (AI), particularly large language models (LLMs), to improve clinical decision-making and enhance the efficiency of HTs. METHODS: Data from patients with severe aortic stenosis presented at HT meetings were retrospectively analysed. A standardised multiple-choice questionnaire, with 14 key variables, was processed by the OpenAI Chat Generative Pre-trained Transformer (GPT)-4. AI-generated decisions were then compared to those made by the HT. RESULTS: This study included 150 patients, with ChatGPT agreeing with the HT's decisions 77% of the time. The agreement rate varied depending on treatment modality: 90% for transcatheter valve implantation, 65% for surgical valve replacement, and 65% for medical treatment. CONCLUSIONS: The use of LLMs offers promising opportunities to improve the HT decision-making process. This study showed that ChatGPT's decisions were consistent with those of the HT in a large proportion of cases. This technology could serve as a failsafe, highlighting potential areas of discrepancy when its decisions diverge from those of the HT. Further research is necessary to solidify our understanding of how AI can be integrated to enhance the decision-making processes of HTs.


Aortic Valve Stenosis , Heart Valve Diseases , Humans , Artificial Intelligence , Retrospective Studies , Heart , Aortic Valve Stenosis/surgery
5.
Article En | MEDLINE | ID: mdl-38427153

This study focuses on identifying anatomical markers with predictive capacity for long-term myocardial infarction (MI) in focal coronary artery disease (CAD). Eighty future culprit lesions (FCL) and 108 non-culprit lesions (NCL) from 80 patients underwent 3D quantitative coronary angiography. The minimum lumen area (MLA), minimum lumen ratio (MLR), and vessel fractional flow reserve (vFFR) were evaluated. MLR was defined as the ratio between MLA and the cross-sectional area at the proximal lesion edge, with lower values indicating more abrupt luminal narrowing. Significant differences were observed between FCL and NCL in MLR (0.41 vs. 0.53, p < 0.001). MLR correlated inversely with translesional vFFR (r = - 0.26, p = 0.0004) and was the strongest predictor of MI at 5 years (AUC = 0.75). Lesions with MLR < 0.40 had a fourfold increased MI incidence at 5 years. MLR is a robust predictor of future adverse coronary events.

6.
J Am Coll Cardiol ; 83(6): 699-709, 2024 Feb 13.
Article En | MEDLINE | ID: mdl-38325996

Diagnosing coronary microvascular dysfunction remains challenging, primarily due to the lack of direct measurements of absolute coronary blood flow (Q) and microvascular resistance (Rµ). However, there has been recent progress with the development and validation of continuous intracoronary thermodilution, which offers a simplified and validated approach for clinical use. This technique enables direct quantification of Q and Rµ, leading to precise and accurate evaluation of the coronary microcirculation. To ensure consistent and reliable results, it is crucial to follow a standardized protocol when performing continuous intracoronary thermodilution measurements. This document aims to summarize the principles of thermodilution-derived absolute coronary flow measurements and propose a standardized method for conducting these assessments. The proposed standardization serves as a guide to ensure the best practice of the method, enhancing the clinical assessment of the coronary microcirculation.


Coronary Circulation , Myocardial Ischemia , Humans , Coronary Circulation/physiology , Vascular Resistance/physiology , Thermodilution/methods , Hemodynamics , Microcirculation/physiology , Coronary Vessels
7.
J Clin Med ; 13(2)2024 Jan 14.
Article En | MEDLINE | ID: mdl-38256589

A growing body of evidence suggests that extrathoracic vascular accesses for transcatheter aortic valve replacement (TAVR) yield favorable outcomes and can be considered as primary alternatives when the gold-standard transfemoral access is contraindicated. Data comparing the transcaval (TCv) to supra-aortic (SAo) approaches (transcarotid, transsubclavian, and transaxillary) for TAVR are lacking. We aimed to compare the outcomes and safety of TCv and SAo accesses for TAVR as alternatives to transfemoral TAVR. A systematic review with meta-analysis was performed by searching PubMed/MEDLINE and EMBASE databases for all articles comparing TCv-TAVR against SAo-TAVR published until September 2023. Outcomes included in-hospital or 30-day all-cause mortality (ACM) and postoperative complications. A total of three studies with 318 TCv-TAVR and 179 SAo-TAVR patients were included. No statistically significant difference was found regarding in-hospital or 30-day ACM (relative risk [RR] 1.04, 95% confidence interval [CI] 0.47-2.34, p = 0.91), major bleeding, the need for blood transfusions, major vascular complications, and acute kidney injury. TCv-TAVR was associated with a non-statistically significant lower rate of neurovascular complications (RR 0.39, 95%CI 0.14-1.09, p = 0.07). These results suggest that both approaches may be considered as first-line alternatives to transfemoral TAVR, depending on local expertise and patients' anatomy. Additional data from long-term cohort studies are needed.

8.
Rev Med Suisse ; 20(856-7): 19-24, 2024 Jan 17.
Article Fr | MEDLINE | ID: mdl-38231094

The year 2023 has been extremely rich in new publications in the various subfields of cardiology. Furthermore, the European Society of Cardiology (ESC) has issued revised guidelines focused on the management of acute coronary syndrome (ACS) and endocarditis, as well as an update on the recommendations for the management of heart failure and cardiovascular prevention. The most significant updates according to the Cardiology Department of CHUV are summarized in this review article.


L'année 2023 a été extrêmement riche en nouvelles publications dans les différents sous-domaines de la cardiologie. De plus, la Société européenne de cardiologie (ESC) a formulé des directives révisées axées sur le management du syndrome coronarien aigu (SCA) et de l'endocardite ainsi qu'une mise à jour des recommandations sur la prise en charge de l'insuffisance cardiaque et la prévention cardiovasculaire. Les nouveautés les plus importantes selon l'équipe du Service de cardiologie du CHUV sont résumées dans cet article de synthèse.


Acute Coronary Syndrome , Cardiology , Endocarditis , Heart Failure , Humans , Heart Failure/diagnosis , Heart Failure/therapy , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/therapy
9.
Ann Biomed Eng ; 52(2): 226-238, 2024 Feb.
Article En | MEDLINE | ID: mdl-37733110

The present study establishes a link between blood flow energy transformations in coronary atherosclerotic lesions and clinical outcomes. The predictive capacity for future myocardial infarction (MI) was compared with that of established quantitative coronary angiography (QCA)-derived predictors. Angiography-based computational fluid dynamics (CFD) simulations were performed on 80 human coronary lesions culprit of MI within 5 years and 108 non-culprit lesions for future MI. Blood flow energy transformations were assessed in the converging flow segment of the lesion as ratios of kinetic and rotational energy values (KER and RER, respectively) at the QCA-identified minimum lumen area and proximal lesion sections. The anatomical and functional lesion severity were evaluated with QCA to derive percentage area stenosis (%AS), vessel fractional flow reserve (vFFR), and translesional vFFR (ΔvFFR). Wall shear stress profiles were investigated in terms of topological shear variation index (TSVI). KER and RER predicted MI at 5 years (AUC = 0.73, 95% CI 0.65-0.80, and AUC = 0.76, 95% CI 0.70-0.83, respectively; p < 0.0001 for both). The predictive capacity for future MI of KER and RER was significantly stronger than vFFR (p = 0.0391 and p = 0.0045, respectively). RER predictive capacity was significantly stronger than %AS and ΔvFFR (p = 0.0041 and p = 0.0059, respectively). The predictive capacity for future MI of KER and RER did not differ significantly from TSVI. Blood flow kinetic and rotational energy transformations were significant predictors for MI at 5 years (p < 0.0001). The findings of this study support the hypothesis of a biomechanical contribution to the process of plaque destabilization/rupture leading to MI.


Coronary Artery Disease , Coronary Stenosis , Fractional Flow Reserve, Myocardial , Myocardial Infarction , Humans , Coronary Vessels , Coronary Angiography , Predictive Value of Tests , Severity of Illness Index
10.
Int J Cardiol ; 399: 131663, 2024 Mar 15.
Article En | MEDLINE | ID: mdl-38141730

BACKGROUND: FFRangio and QFR are angiography-based technologies that have been validated in patients with stable coronary artery disease. No head-to-head comparison to invasive fractional flow reserve (FFR) has been reported to date in patients with acute coronary syndromes (ACS). METHODS: This study is a subset of a larger prospective multicenter, single-arm study that involved patients diagnosed with high-risk ACS in whom 30-70% stenosis was evaluated by FFR. FFRangio and QFR - both calculated offline by 2 different and blinded operators - were calculated and compared to FFR. The two co-primary endpoints were the comparison of the Pearson correlation coefficient between FFRangio and QFR with FFR and the comparison of their inter-observer variability. RESULTS: Among 134 high-risk ACS screened patients, 59 patients with 84 vessels underwent FFR measurements and were included in this study. The mean FFR value was 0.82 ± 0.40 with 32 (38%) being ≤0.80. The mean FFRangio was 0.82 ± 0.20 and the mean QFR was 0.82 ± 0.30, with 27 (32%) and 25 (29%) being ≤0.80, respectively. The Pearson correlation coefficient was significantly better for FFRangio compared to QFR, with R values of 0.76 and 0.61, respectively (p = 0.01). The inter-observer agreement was also significantly better for FFRangio compared to QFR (0.86 vs 0.79, p < 0.05). FFRangio had 91% sensitivity, 100% specificity, and 96.8% accuracy, while QFR exhibited 86.4% sensitivity, 98.4% specificity, and 93.7% accuracy. CONCLUSION: In patients with high-risk ACS, FFRangio and QFR demonstrated excellent diagnostic performance. FFRangio seems to have better correlation to invasive FFR compared to QFR but further larger validation studies are required.


Acute Coronary Syndrome , Coronary Artery Disease , Coronary Stenosis , Fractional Flow Reserve, Myocardial , Humans , Prospective Studies , Coronary Stenosis/diagnostic imaging , Coronary Angiography/methods , Acute Coronary Syndrome/diagnostic imaging , Predictive Value of Tests , Coronary Vessels , Severity of Illness Index
11.
J Neuroeng Rehabil ; 20(1): 167, 2023 12 13.
Article En | MEDLINE | ID: mdl-38093374

BACKGROUND: Early Mobilization in Intensive Care Units (ICUs) enhances patients' evolution, but has been rarely studied in neurological ICUs. The aim of this study was to assess gait training with body-weight support (BWS) in neuroICU, and to report on its safety, feasibility and on delays before walking with and without BWS. METHODS: This study was an observational one-year single-center study. Inclusion criteria were adults with a neurological injury requiring mechanical ventilation. Exclusion criteria were early death or ICU transfer. After weaning from ventilation, patients were screened for indications of BWS walking using predefined criteria. RESULTS: Patients' conditions were mostly brain injuries: 32% subarachnoid hemorrhages, 42% focal strokes, and 12% traumatic brain injuries. Out of 272 admissions, 136 patients were excluded, 78 were eligible, and 33 performed BWS walking. Among non-eligible patients, 36 walked unsuspended upon ventilation weaning, 17 presented too severe impairments. Among the 45 eligible patients who did not receive BWS training, main reasons were workload and weekends (31%), medical barriers (29%), and early ICU discharge (22%). 78 BWS sessions were performed on the 33 beneficiaries (median sessions per patient 2, max 10). Pre-session, most patients had inadequate response to pain, orders, or simple orientation questions. Sitting without support was impossible for 74%. Most pre-post changes in hemodynamic, respiratory, and pain parameters were small, and recovered spontaneously after the session. Eight sessions were interrupted; reasons were pain, fatigue or major imbalance (4), syncope (1), occurrence of stool (2), and battery failure (1). None of these adverse events required medical intervention, patients recovered upon session interruption. Median session duration was 31 min, patients walked on median 17 m. First BWS session occurred on median 3 days after ventilation weaning, and 11 days before patients were able to walk unsuspended. CONCLUSIONS: Verticalization and walking using a suspension device in patients in neuroICU allows early gait training, despite challenging neurological impairments. It is safe and generally well tolerated. TRIAL REGISTRATION: ClinicalTrials database (ID: NCT04300491).


Gait , Walking , Adult , Humans , Feasibility Studies , Walking/physiology , Gait/physiology , Critical Care , Pain
13.
Curr Cardiol Rep ; 25(11): 1425-1431, 2023 11.
Article En | MEDLINE | ID: mdl-37815660

PURPOSE OF REVIEW: As TAVR is increasingly performed on younger patients with a longer life expectancy, the number of redo-TAVR procedures is likely to increase in the coming years. Limited data is currently available on this sometimes challenging procedure. We provide a summary of currently published literature on management of patients with a failed transcatheter aortic valve. RECENT FINDINGS: Recent registry data have increased the clinical knowledge on redo-TAVR. Additionally, numerous bench studies have provided valuable insights into the technical aspects of redo-TAVR with various combinations of valve types. Redo-TAVR can be performed safely in selected cases with a high procedural success and good short-term outcomes. However, at present, the procedure remains relatively infrequent and many patients are not eligible. Bench testing can be useful to understand important concepts such as valve expansion, neoskirt, leaflet overhang, and leaflet deflection as well as their potential clinical implications.


Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/methods , Aortic Valve Stenosis/surgery , Treatment Outcome , Aortic Valve/surgery , Risk Factors , Prosthesis Design
14.
J Cardiovasc Dev Dis ; 10(10)2023 Oct 12.
Article En | MEDLINE | ID: mdl-37887871

BACKGROUND: Coronary CT angiography (CCTA) is increasingly used as a non-invasive tool to assess coronary artery disease (CAD). However, CCTA is subject to motion artifacts, potentially limiting its clinical utility. Despite faster (0.35 and 0.28 s/rot) gantry rotation times, low (60-65 bpm) heartbeat is recommended, and the use of ß-blockers is often needed. Technological advancements have resulted in the development of faster rotation speeds (0.23 s/rot). However, their added value in patients not premedicated with ß-blockers remains unclear. This prospective single-center, two-arm, randomized, controlled trial aims to assess the influence of fast rotation on coronary motion artifacts, diagnostic accuracy of CCTA for CAD, and patient safety. METHODS: We will randomize a total of 142 patients aged ≥ 50 scheduled for an aortic stenosis work-up to receive CCTA with either a fast (0.23) or standard (0.28 s/rot) gantry speed. PRIMARY OUTCOME: rate of CCTAs with coronary motion artifacts hindering interpretation. SECONDARY OUTCOMES: assessable coronary segments rate, diagnostic accuracy against invasive coronary angiography (ICA), motion artifact magnitude per segment, contrast-to-noise ratio (CNR), and patient ionizing radiation dose. The local ethics committee has approved the protocol. Potential significance: FAST-CCT may improve motion artifact reduction and diagnosis quality, thus eliminating the need for rate control and ß-blocker administration. CLINICALTRIALS: gov identifier: NCT05709652.

17.
JACC Cardiovasc Interv ; 16(19): 2396-2408, 2023 10 09.
Article En | MEDLINE | ID: mdl-37821185

BACKGROUND: Low fractional flow reserve (FFR) after percutaneous coronary intervention (PCI) has been associated with adverse clinical outcomes. Hitherto, this assessment has been independent of the epicardial vessel interrogated. OBJECTIVES: This study sought to assess the predictive capacity of post-PCI FFR for target vessel failure (TVF) stratified by coronary artery. METHODS: We performed a systematic review and individual patient-level data meta-analysis of randomized clinical trials and observational studies with protocol-recommended post-PCI FFR assessment. The difference in post-PCI FFR between left anterior descending (LAD) and non-LAD arteries was assessed using a random-effect models meta-analysis of mean differences. TVF was defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization. RESULTS: Overall, 3,336 vessels (n = 2,760 patients) with post-PCI FFR measurements were included in 9 studies. The weighted mean post-PCI FFR was 0.89 (95% CI: 0.87-0.90) and differed significantly between coronary vessels (LAD = 0.86; 95% CI: 0.85 to 0.88 vs non-LAD = 0.93; 95% CI: 0.91-0.94; P < 0.001). Post-PCI FFR was an independent predictor of TVF, with its risk increasing by 52% for every reduction of 0.10 FFR units, and this was mainly driven by TVR. The predictive capacity for TVF was poor for LAD arteries (AUC: 0.52; 95% CI: 0.47-0.58) and moderate for non-LAD arteries (AUC: 0.66; 95% CI: 0.59-0.73; LAD vs non-LAD arteries, P = 0.005). CONCLUSIONS: The LAD is associated with a lower post-PCI FFR than non-LAD arteries, emphasizing the importance of interpreting post-PCI FFR on a vessel-specific basis. Although a higher post-PCI FFR was associated with improved prognosis, its predictive capacity for events differs between the LAD and non-LAD arteries, being poor in the LAD and moderate in the non-LAD vessels.


Coronary Artery Disease , Fractional Flow Reserve, Myocardial , Percutaneous Coronary Intervention , Humans , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Percutaneous Coronary Intervention/adverse effects , Coronary Angiography , Treatment Outcome , Predictive Value of Tests
19.
EuroIntervention ; 19(8): 634-651, 2023 Oct 23.
Article En | MEDLINE | ID: mdl-37624587

Valvular heart disease (VHD) is one of the most frequent causes of heart failure (HF) and is associated with poor prognosis, particularly among patients with conservative management. The development and improvement of catheter-based VHD interventions have broadened the indications for transcatheter valve interventions from inoperable/high-risk patients to younger/lower-risk patients. Cardiogenic shock (CS) associated with severe VHD is a clinical condition with a very high risk of mortality for which surgical treatment is often deemed a prohibitive risk. Transcatheter valve interventions might be a promising alternative in this setting given that they are less invasive. However, supportive scientific evidence is scarce and often limited to small case series. Current guidelines on VHD do not contain specific recommendations on how to manage patients with both VHD and CS. The purpose of this clinical consensus statement, developed by a group of international experts invited by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Scientific Documents and Initiatives Committee, is to perform a review of the available scientific evidence on the management of CS associated with left-sided VHD and to provide a rationale and practical approach for the application of transcatheter valve interventions in this specific clinical setting.

20.
Am Heart J ; 265: 170-179, 2023 Nov.
Article En | MEDLINE | ID: mdl-37611857

INTRODUCTION: Diffuse disease has been identified as one of the main reasons leading to low post-PCI fractional flow reserve (FFR) and residual angina after PCI. Coronary pressure pullbacks allow for the evaluation of hemodynamic coronary artery disease (CAD) patterns. The pullback pressure gradient (PPG) is a novel metric that quantifies the distribution and magnitude of pressure losses along the coronary artery in a focal-to-diffuse continuum. AIM: The primary objective is to determine the predictive capacity of the PPG for post-PCI FFR. METHODS: This prospective, large-scale, controlled, investigator-initiated, multicenter study is enrolling patients with at least 1 lesion in a major epicardial vessel with a distal FFR ≤ 0.80 intended to be treated by PCI. The study will include 982 subjects. A standardized physiological assessment will be performed pre-PCI, including the online calculation of PPG from FFR pullbacks performed manually. PPG quantifies the CAD pattern by combining several parameters from the FFR pullback curve. Post-PCI physiology will be recorded using a standardized protocol with FFR pullbacks. We hypothesize that PPG will predict optimal PCI results (post-PCI FFR ≥ 0.88) with an area under the ROC curve (AUC) ≥ 0.80. Secondary objectives include patient-reported and clinical outcomes in patients with focal vs. diffuse CAD defined by the PPG. Clinical follow-up will be collected for up to 36 months, and an independent clinical event committee will adjudicate events. RESULTS: Recruitment is ongoing and is expected to be completed in the second half of 2023. CONCLUSION: This international, large-scale, prospective study with pre-specified powered hypotheses will determine the ability of the preprocedural PPG index to predict optimal revascularization assessed by post-PCI FFR. In addition, it will evaluate the impact of PPG on treatment decisions and the predictive performance of PPG for angina relief and clinical outcomes.

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