Technical and Clinical Outcomes After Transcatheter Edge-to-Edge Repair of Mitral Regurgitation in Male and Female Patients: Is Equality Achieved?

BACKGROUND: Currently, no clear impact of sex on short- and long-term survival following transcatheter edge-to-edge mitral valve repair (TEER) is evident, although no data are available on postprocedural life expectancy. Our aim was to assess sex-specific differences in outcomes of patients with mitral regurgitation (MR) treated by TEER. METHODS AND RESULTS: Short-term and 5-year outcomes in men and women undergoing TEER between 2011 and 2018 who were included in the large, multicenter, real-world MitraSwiss registry were analyzed. Outcomes were compared stratified by sex and according to MR cause (primary versus secondary). The impact of TEER on postprocedural life expectancy was estimated by relative survival analysis. Among 1142 patients aged 60 to 89 years, 39.8% were women. They were older, with fewer cardiovascular risk factors and lower functional capacity compared with men. Thirty-day mortality was higher in men than in women (3.3% versus 1.1%; odds ratio, 3.16 [95% CI, 1.16-10.7]; P=0.020). Five-year survival was comparable in both sexes (adjusted hazard ratio for 5-year mortality in men, 1.14 [95% CI, 0.90-1.44], P=0.275). Both men and women with either primary or secondary MR showed similar clinical efficacy over time. TEER provided high relative survival estimates among all groups, and fully restored predicted life expectancy in women with primary MR (5-year relative survival estimate, 97.4% [95% CI, 85.5-107.0]). CONCLUSIONS: TEER is not associated with increased short-term mortality in women, whereas 5-year outcomes are comparable between sexes. Moreover, TEER completely restored normal life expectancy in women with primary MR. A residual excess mortality persists in secondary MR, independently of sex.

A systematic review for the evidence of recommendations and guidelines in hybrid nuclear cardiovascular imaging.

OBJECTIVES: This study aimed to evaluate the level of evidence of expert recommendations and guidelines for clinical indications and procedurals in hybrid nuclear cardiovascular imaging. METHODS: From inception to August 2023, a PubMed literature analysis of the latest version of guidelines for clinical hybrid cardiovascular imaging techniques including SPECT(/CT), PET(/CT), and PET(/MRI) was performed in two categories: (1) for clinical indications for all-in primary diagnosis; subgroup in prognosis and therapy evaluation; and for (2) imaging procedurals. We surveyed to what degree these followed a standard methodology to collect the data and provide levels of evidence, and for which topic systematic review evidence was executed. RESULTS: A total of 76 guidelines, published between 2013 and 2023, were included. The evidence of guidelines was based on systematic reviews in 7.9% of cases, non-systematic reviews in 47.4% of cases, a mix of systematic and non-systematic reviews in 19.7%, and 25% of guidelines did not report any evidence. Search strategy was reported in 36.8% of cases. Strengths of recommendation were clearly reported in 25% of guidelines. The notion of external review was explicitly reported in 23.7% of cases. Finally, the support of a methodologist was reported in 11.8% of the included guidelines. CONCLUSION: The use of evidence procedures for developing for evidence-based cardiovascular hybrid imaging recommendations and guidelines is currently suboptimal, highlighting the need for more standardized methodological procedures.

Non-Invasive Assessment of Endothelial Shear Stress in Myocardial Bridges Using Coronary Computed Tomography Angiography.

Myocardial bridging (MB) is a segment of coronary arteries with an intramural course, typically spared from atherosclerosis, while the adjacent proximal segment is reported to be atherosclerosis-prone, a phenomenon contributed to local endothelial shear stress (ESS). We aimed to describe the ESS milieu in coronaries with MBs combining coronary computed tomography angiography with computational fluid dynamics and to investigate the association of atherosclerosis presence proximal to MBs with hemorheological characteristics. Patients (n = 36) were identified and 36 arteries with MBs (11 deep and 25 superficial) were analyzed. ESS did not fluctuate 5 mm proximally to MBs vs 5 mm within MBs (0.94 vs 1.06 Pa, p = .56). There was no difference when comparing ESS in the proximal versus mid versus distal MB segments (1.48 vs 1.37 vs 1.9 Pa, p = ns). In arteries with plaques (n = 12), no significant ESS variances were observed around the MB entrance, when analyzing all arteries (p = .81) and irrespective of morphological features of the bridged segment (deep MBs; p = .65, superficial MBs; p = .84). MBs are characterized by homogeneous, atheroprotective ESS, possibly explaining the absence of atherosclerosis within bridged segments. The interplay between ESS and atherosclerosis is potentially not different in arteries with MB compared with arteries without bridges.

Restoration of Life Expectancy After Transcatheter Edge-to-Edge Mitral Valve Repair.

BACKGROUND: Survival data after mitral transcatheter edge-to-edge repair (TEER) are scarce, and its impact on predicted life expectancy is unknown. OBJECTIVES: The aim of this study was to estimate the impact of TEER on postprocedural life expectancy among patients enrolled in the MitraSwiss registry through a relative survival (RS) analysis. METHODS: Consecutive TEER patients 60 to 89 years of age enrolled between 2011 and 2018 (N = 1140) were evaluated. RS was defined as the ratio between post-TEER survival and expected survival in an age-, sex- and calendar period-matched group derived from the Swiss national 2011 to 2019 mortality tables. The primary aim was to assess 5-year survival and RS after TEER. The secondary aim was to assess RS according to the etiology of mitral regurgitation, age class and sustained procedural success over time. RESULTS: Overall, 5-year survival after TEER was 59.3% (95% CI: 54.9%-63.4%), whereas RS reached 80.5% (95% CI: 74.6%-86.0%). RS was 91.1% (95% CI: 82.5%-98.6%) in primary mitral regurgitation (PMR) and 71.5% (95% CI: 63.0%-79.3%) in secondary mitral regurgitation (SMR). Patients 80 to 89 years of age (n = 579) showed high 5-year RS (93.0%; 95% CI: 83.3%-101.9%). In this group, restoration of predicted life expectancy was achieved in PMR with a 5-year RS of 100% (95% CI: 87.9%-110.7%), whereas sustained procedural success increased the RS rate to 90.6% (95% CI: 71.3%-107.3%) in SMR. CONCLUSIONS: Mitral TEER in patients 80 to 89 years of age is able to restore predicted life expectancy in PMR, whereas in SMR with sustained procedural success, high RS estimates were observed. Our analysis suggests that successful, sustained mitral regurgitation reduction is key to survival improvement, particularly in patients 80 to 89 years of age.

Transcatheter Aortic Valve Implantation With Balloon-Expandable Valve Prostheses in Patients With Pure Native Non- or Mildly Calcified Aortic Regurgitation: A Case-Series and Literature Review.

OBJECTIVE: Transcatheter aortic valve implantation (TAVI) is an off-label procedure for selected patients at high surgical risk with native non- or mildly calcified aortic regurgitation (AR). Traditionally, self-expanding transcatheter heart valves (THV) have been favored over balloon-expandable THV's probably due to assumed better device fixation. We report a series of patients with native severe AR successfully treated with a balloon-expandable THV. METHODS: Between 2019 and 2022, 8 consecutive patients (5 male, 82 (interquartile range 80-85) years old, STS PROM 4.0 % (interquartile range 2.9-6.0), EuroSCORE II 5.5% (IQR 4.1-7.0) with non- or mildly calcified pure AR were treated with a balloon-expandable THV. All procedures were performed after heart team discussion and standardized diagnostic workup. Clinical endpoints were collected prospectively and included device success, procedural complications (according to VARC-2 definitions) and 1-month survival. RESULTS: Device success was 100% with no device embolization or migration. Two preprocedural nonfatal complications were reported (one access site complication that required stent implantation and one pericardial tamponade). Two patients required permanent pacemaker implantation for complete AV block. At discharge and at 30-day follow-up all patients were alive and no patient showed more than minimal AR. CONCLUSION: This series documents that treatment of native non- or mildly calcified AR with balloon-expandable THV is feasible, safe and offers favorable short-term clinical outcomes. Hence, TAVI with balloon-expandable THVs may offer a valuable treatment option in patients with native AR at high surgical risk.

Trends in Coronary and Structural Heart Interventions in Switzerland over the Last 16 Years and Impact of COVID-19: Insights from the National Swiss PCI Survey.

BACKGROUND: Considering the global burden of cardiovascular disease, we analysed trends in interventional coronary and structural procedures over the past 16 years (2005-2021), using continuous data from the Swiss national registry. METHODS: Based on a standardised questionnaire, data on coronary and structural interventions in Switzerland were assessed by the Working Group Interventional Cardiology of the Swiss Society of Cardiology (SSC). Here, we analysed the trend of annually performed interventions from 2005 to 2021 in Switzerland and the impact of the COVID-19 pandemic. RESULTS: We observed a constant increase in the total number of cases (including coronary angiographies (CA) and percutaneous coronary interventions (PCI)) from 36,436 cases in 2005 to 56,555 cases in 2021 (+55%). With 18 cases in 2007, TAVI procedures have increased to 2004 cases in 2021. During the early phase of the COVID-19 pandemic in 2020, a slight decrease in CAs and PCIs of 9.15% was observed. In contrast, we did not observe an impact of the COVID-19 pandemic on the number of no TAVI procedures. Most importantly, all cause in-hospital mortality for coronary interventions before and during the peak of the COVID-19 pandemic was comparable (1.4% vs. 1.3%). CONCLUSION: Over a 16-year period, we observed an upward trend in diagnostic and therapeutic procedures for coronary as well as structural heart disease, with only a small short-term impact of the COVID-19 pandemic on interventions and a similar procedure-related in-hospital-mortality in Switzerland.

Clinical applications of cardiac computed tomography: a consensus paper of the European Association of Cardiovascular Imaging-part II.

Cardiac computed tomography (CT) was initially developed as a non-invasive diagnostic tool to detect and quantify coronary stenosis. Thanks to the rapid technological development, cardiac CT has become a comprehensive imaging modality which offers anatomical and functional information to guide patient management. This is the second of two complementary documents endorsed by the European Association of Cardiovascular Imaging aiming to give updated indications on the appropriate use of cardiac CT in different clinical scenarios. In this article, emerging CT technologies and biomarkers, such as CT-derived fractional flow reserve, perfusion imaging, and pericoronary adipose tissue attenuation, are described. In addition, the role of cardiac CT in the evaluation of atherosclerotic plaque, cardiomyopathies, structural heart disease, and congenital heart disease is revised.

Clinical applications of cardiac computed tomography: a consensus paper of the European Association of Cardiovascular Imaging-part I.

Cardiac computed tomography (CT) was introduced in the late 1990's. Since then, an increasing body of evidence on its clinical applications has rapidly emerged. From an initial emphasis on its technical efficiency and diagnostic accuracy, research around cardiac CT has now evolved towards outcomes-based studies that provide information on prognosis, safety, and cost. Thanks to the strong and compelling data generated by large, randomized control trials, the scientific societies have endorsed cardiac CT as pivotal diagnostic test for the management of appropriately selected patients with acute and chronic coronary syndrome. This consensus document endorsed by the European Association of Cardiovascular Imaging is divided into two parts and aims to provide a summary of the current evidence and to give updated indications on the appropriate use of cardiac CT in different clinical scenarios. This first part focuses on the most established applications of cardiac CT from primary prevention in asymptomatic patients, to the evaluation of patients with chronic coronary syndrome, acute chest pain, and previous coronary revascularization.

Position paper of the EACVI and EANM on artificial intelligence applications in multimodality cardiovascular imaging using SPECT/CT, PET/CT, and cardiac CT.

In daily clinical practice, clinicians integrate available data to ascertain the diagnostic and prognostic probability of a disease or clinical outcome for their patients. For patients with suspected or known cardiovascular disease, several anatomical and functional imaging techniques are commonly performed to aid this endeavor, including coronary computed tomography angiography (CCTA) and nuclear cardiology imaging. Continuous improvement in positron emission tomography (PET), single-photon emission computed tomography (SPECT), and CT hardware and software has resulted in improved diagnostic performance and wide implementation of these imaging techniques in daily clinical practice. However, the human ability to interpret, quantify, and integrate these data sets is limited. The identification of novel markers and application of machine learning (ML) algorithms, including deep learning (DL) to cardiovascular imaging techniques will further improve diagnosis and prognostication for patients with cardiovascular diseases. The goal of this position paper of the European Association of Nuclear Medicine (EANM) and the European Association of Cardiovascular Imaging (EACVI) is to provide an overview of the general concepts behind modern machine learning-based artificial intelligence, highlights currently prefered methods, practices, and computational models, and proposes new strategies to support the clinical application of ML in the field of cardiovascular imaging using nuclear cardiology (hybrid) and CT techniques.

Value of 12-lead electrocardiogram to predict myocardial scar on FDG PET in heart failure patients.

PURPOSE: A surface 12-lead electrocardiogram (ECG) is widely available, fast, inexpensive, and safe. However, its value to predict a true myocardial scar in patients with ischemic cardiomyopathy (ICM) has not been studied extensively yet. This study was conducted to assess whether Q waves on resting surface 12-lead ECG are predictive of non-viable myocardium in patients with ICM. METHODS: We analyzed resting ECGs of 149 patients with ICM undergoing cardiac positron emission tomography (PET) with 13N-ammonia (NH3) and 18F-fluorodeoxyglucose (FDG) at our institution. Pathological Q waves and QS complexes were assigned to one of three coronary artery territories and compared to the PET findings. Myocardial scar was defined as 2 or more contiguous myocardial segments with an average (matched) reduction of NH3 and FDG uptake <50% of the maximum value. RESULTS: Pathological Q waves had a sensitivity and specificity of 70% and 40%, respectively, and a PPV and NPV of 37% and 73%, respectively, to detect myocardial scar on FDG PET. For QS complexes, sensitivity and specificity were 46% and 59%, respectively, and PPV and NPV were 36% and 68%, respectively. Sensitivity was lower, but specificity was significantly higher in both the LCX and RCA compared to the LAD territory (p<0.001), particularly for QS complexes. CONCLUSION: Pathological Q waves on resting 12-lead ECG have poor or at best moderate sensitivity and specificity to detect myocardial scar on FDG PET. These findings support the use of more advanced imaging techniques to assess myocardial viability in ICM.

Procedural recommendations of cardiac PET/CT imaging: standardization in inflammatory-, infective-, infiltrative-, and innervation (4Is)-related cardiovascular diseases: a joint collaboration of the EACVI and the EANM.

With this document, we provide a standard for PET/(diagnostic) CT imaging procedures in cardiovascular diseases that are inflammatory, infective, infiltrative, or associated with dysfunctional innervation (4Is). This standard should be applied in clinical practice and integrated in clinical (multicenter) trials for optimal procedural standardization. A major focus is put on procedures using [18F]FDG, but 4Is PET radiopharmaceuticals beyond [18F]FDG are also described in this document. Whilst these novel tracers are currently mainly applied in early clinical trials, some multicenter trials are underway and we foresee in the near future their use in clinical care and inclusion in the clinical guidelines. Finally, PET/MR applications in 4Is cardiovascular diseases are also briefly described. Diagnosis and management of 4Is-related cardiovascular diseases are generally complex and often require a multidisciplinary approach by a team of experts. The new standards described herein should be applied when using PET/CT and PET/MR, within a multimodality imaging framework both in clinical practice and in clinical trials for 4Is cardiovascular indications.

New Therapies to Modulate Post-Infarction Inflammatory Alterations in the Myocardium: State of the Art and Forthcoming Applications.

Acute myocardial infarction (AMI) is a major cause of morbidity and mortality worldwide. AMI causes necrosis of cardiac cells and triggers a complex inflammatory response, affecting infarct size, cardiac function and clinical outcomes. This inflammatory response can be divided into 3 phases: 1) the pro-inflammatory phase, in which the release of damage-associated molecular patterns from necrotic cells triggers the secretion of pro-inflammatory mediators and attracts immune cells to clean the debris, further damaging viable myocardium, 2) the reparative phase, in which anti-inflammatory signals activate immune-modulating cells and trigger the production of a stable scar, 3) the maturation phase, in which inflammatory and fibrotic signals are suppressed, but may persist, leading to left ventricular adverse remodelling. Thus, the inflammatory response is an appealing therapeutic target to improve the outcomes of patients with AMI. Numerous anti-inflammatory therapies have shown potential in animal models, but the translation to human trials exhibited limited benefit. Glucocorticoids and non-steroidal anti-inflammatory drugs showed signals of harm due to their non-specific effects. Other broad inhibitors, e.g., methotrexate, cyclosporine, or colchicine, did not improve clinical outcomes as acute therapies for MI. Specific inhibitors of the complement cascade, adhesion molecules, or inflammatory mediators were mostly disappointing in humans. However, an interleukin-1 inhibitor (anakinra) and a matrix metalloproteinase inhibitor (doxycycline) improved clinical outcomes in patients with AMI. Promising RNAse1, anti-toll-like receptor 2 antibodies, and inflammasome inhibitors still need to be tested in humans. Finally, positive results should be replicated in large clinical trials before they can be implemented into the standard AMI therapy.