LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial.

BACKGROUND: Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1·5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA). METHODS: In this prospective, multinational, randomised, open-label, non-inferiority trial across 31 hospitals in 16 countries (Germany, France, Sweden, the Netherlands, Italy, Spain, New Zealand, Portugal, Greece, Hungary, Poland, Slovakia, Slovenia, Croatia, Estonia, and Brazil), 768 participants with severe symptomatic native aortic stenosis were randomly assigned (1:1) to the Myval THV or a contemporary THV. Eligibility was primarily decided by the heart team in accordance with 2021 European Society of Cardiology guidelines. As per the criteria of the third Valve Academic Research Consortium, the primary endpoint at 30 days was a composite of all-cause mortality, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2-4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction system disturbances resulting in a permanent pacemaker implantation. Non-inferiority of the study device was tested in the intention-to-treat population using a non-inferiority margin of 10·44% and assuming an event rate of 26·10%. This trial is registered with ClinicalTrials.gov, NCT04275726, and EudraCT, 2020-000137-40, and is closed to new participants. FINDINGS: Between Jan 6, 2021, and Dec 5, 2023, 768 participants with severe symptomatic native aortic stenosis were randomly assigned, 384 to the Myval THV and 384 to a contemporary THV. 369 (48%) participants had their sex recorded as female, and 399 (52%) as male. The mean age of participants was 80·0 years (SD 5·7) for those treated with the Myval THV and 80·4 years (5·4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2·6% [IQR 1·7-4·0] vs contemporary 2·6% [1·7-4·0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of -2·3% (one-sided upper 95% CI 3·8, pnon-inferiority<0·0001). No significant difference was seen in individual components of the primary composite endpoint. INTERPRETATION: In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days. FUNDING: Meril Life Sciences.

Treatment of late paravalvular regurgitation after transcatheter aortic valve implantation: prognostic implications.

AIMS: Paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The effect of transcatheter interventions to treat PVR after the index TAVI was investigated. METHODS AND RESULTS: A registry of consecutive patients who underwent transcatheter intervention for ≥ moderate PVR after the index TAVI at 22 centers. The principal outcomes were residual aortic regurgitation (AR) and mortality at 1 year after PVR treatment. A total of 201 patients were identified: 87 (43%) underwent redo-TAVI, 79 (39%) plug closure, and 35 (18%) balloon valvuloplasty. Median TAVI-to-re-intervention time was 207 (35; 765) days. The failed valve was self-expanding in 129 (63.9%) patients. The most frequent devices utilized were a Sapien 3 valve for redo-TAVI (55, 64%), an AVP II as plug (33, 42%), and a True balloon for valvuloplasty (20, 56%). At 30 days, AR ≥ moderate persisted in 33 (17.4%) patients: 8 (9.9%) after redo-TAVI, 18 (25.9%) after plug, and 7 (21.9%) after valvuloplasty (P = 0.036). Overall mortality was 10 (5.0%) at 30 days and 29 (14.4%) at 1 year: 0, 8 (10.1%), and 2 (5.7%) at 30 days (P = 0.010) and 11 (12.6%), 14 (17.7%), and 4 (11.4%) at 1 year (P = 0.418), after redo-TAVI, plug, and valvuloplasty, respectively. Regardless of treatment strategy, patients in whom AR was reduced to ≤ mild had lower mortality at 1 year compared with those with AR persisting ≥ moderate [11 (8.0%) vs. 6 (21.4%); P = 0.007]. CONCLUSION: This study describes the efficacy of transcatheter treatments for PVR after TAVI. Patients in whom PVR was successfully reduced had better prognosis. The selection of patients and the optimal PVR treatment modality require further investigation.

Improved Endothelial and Autonomic Function after Transcatheter Aortic Valve Implantation.

Background: Degenerative aortic stenosis is an atherosclerotic-like process associated with impaired endothelial and autonomic function. Transcatheter aortic valve implantation (TAVI) has become a treatment of choice for patient with severe degenerative aortic stenosis at high surgical risk. The effect of this procedure on endothelial function measured with flow mediated dilatation (FMD) and autonomic function measured with heart rate variability (HRV) at different time-points of disease management (early and late follow-up) remains unknown. Methods: We prospectively included 50 patients with severe aortic stenosis who were deemed suitable for TAVI by the Heart Team. FMD and HRV parameters were collected at baseline ( < 24 h pre-TAVI), at early follow-up (up to 48 h post-TAVI) and at late follow-up (3-6 months post-TAVI). Results: 43 patients (mean age 81 (75-85); 60% women) completed the study. FMD significantly improved from 2.8 ± 1.5% before TAVI to 4.7 ± 2.7% early after TAVI (p < 0.001) and was later maintained on late follow-up (4.8 ± 2.7%, p = 0.936). Conversely, high-resolution ECG parameters remained preserved at early and improved at late follow-up after TAVI. Significant improvement was detected in a high frequency-domain parameter-HF (from 5231 ± 1783 to 6507 ± 1789 ms 2 ; p = 0.029) and in two Poincare plot parameters: ratio of the short- and long-term R-R variability in the Poincare plot-SD1/SD2 (from 0.682 to 0.884 ms 2 ; p = 0.003) and short-term R-R variability in the Poincare plot-SDRR (from 9.6 to 23.9 ms; p = 0.001). Echocardiographic parameters comprising baseline maximal aortic valve velocity (R = 0.415; p = 0.011), mean aortic gradient (R = 0.373; p = 0.018), indexed stroke volume (R = 0.503; p = 0.006), change in aortic valve maximal velocity (R = 0.365; p = 0.031), change in mean aortic gradient (R = 0.394; p = 0.019) and NT-proBNP (R = 0.491; p = 0.001) were found as significant predictors of change in FMD. Conclusions: Endothelial function measured with FMD and autonomic function obtained with HRV parameters significantly improve after TAVI. While endothelial function improves early and is maintained later after TAVI, autonomic function remains stable and improves on late follow-up. This is most likely caused by early hemodynamic changes after resolution of aortic valve obstruction and gradual left ventricular remodeling. Clinical Trial Registration: www.clinicaltrials.gov, identifier NCT04286893.

The Impact of Coronary Sinus Reducer on Arrhythmic Properties in Patients with Refractory Angina.

Background: Treatment with a coronary sinus reducer (CSR) is a new therapeutic option for refractory angina patients. Preclinical studies have shown antiarrhythmic properties of coronary sinus narrowing. The possible antiarrhythmic effect of CSR implantation is unknown. This study aimed to determine the possible antiarrhythmic effects of CSR implantation as assessed by high-resolution electrocardiogram (hrECG) parameters. Methods: 24 patients from the Crossroad study randomized to either CSR treatment (n = 12) or a sham procedure (n = 12) had hrECG recorded at baseline and after 6 months. T-peak and T-end interval (TpTe) defined as the time difference between the peak amplitude of the T wave and the global end of the T wave, spatial angle between QRS complex and T axis defined as the angle between the ventricular depolarization and repolarization vectors using maximal (QRSTP) and mean (QRSTM) vector amplitudes and spatial ventricular gradient (SVG) calculated as integral of ECG voltages over the entire QRST complex were analyzed. Additionally, we analyzed parameters of QT and heart rate variability using time and frequency domain. Results: At baseline, all analyzed parameters were comparable between both groups and heart rate remained constant. The intragroup analysis did not show any significant change in TpTe, QRSTP, QRSTM, SVG, QT, and heart rate variability at follow-up. Furthermore, intergroup comparison between CSR implantation and sham procedure also did not show any significant difference in the change of analyzed parameters. Conclusions: Compared to the sham procedure, CSR implantation did not demonstrate a significant impact on the arrhythmogenic substrate assessed with hrECG. Clinical Trial Registration: Unique Identifier: NCT04121845, https://classic.clinicaltrials.gov/ct2/show/NCT04121845.

Abdominal Stent-Graft Treatment of Ascending Aortic Pseudoaneurysm Following Transcatheter Aortic Valve Implantation.

An ascending aortic pseudoaneurysm is a potentially lethal complication in aortic procedures. We present a hybrid approach using surgical innominate artery access and the endovascular insertion of an abdominal stent-graft extension to successfully treat a zone 0 ascending aortic pseudoaneurysm in a patient with a prior valve-in-valve transcatheter aortic valve implantation.

Optimal use of lipid-lowering therapy after acute coronary syndromes: A Position Paper endorsed by the International Lipid Expert Panel (ILEP).

Atherosclerotic cardiovascular disease (ASCVD) and consequent acute coronary syndromes (ACS) are substantial contributors to morbidity and mortality across Europe. Much of these diseases burden is modifiable, in particular by lipid-lowering therapy (LLT). Current guidelines are based on the sound premise that with respect to low density lipoprotein cholesterol (LDL-C), "lower is better for longer", and the recent data have strongly emphasized the need of also "the earlier the better". In addition to statins, which have been available for several decades, the availability of ezetimibe and inhibitors of proprotein convertase subtilisin/kexin type 9 (PCSK9) are additional very effective approach to LLT, especially for those at very high and extremely high cardiovascular risk. LLT is initiated as a response to an individual's calculated risk of future ASCVD and is intensified over time in order to meet treatment goals. However, in real-life clinical practice goals are not met in a substantial proportion of patients. This Position Paper complements existing guidelines on the management of lipids in patients following ACS. Bearing in mind the very high risk of further events in ACS, we propose practical solutions focusing on immediate combination therapy in strict clinical scenarios, to improve access and adherence to LLT in these patients. We also define an 'Extremely High Risk' group of individuals following ACS, completing the attempt made in the recent European guidelines, and suggest mechanisms to urgently address lipid-medicated cardiovascular risk in these patients.

Mapping interventional cardiology in Europe: the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Atlas Project.

AIMS: The European Association of Percutaneous Cardiovascular Interventions (EAPCI) Atlas of Interventional Cardiology has been developed to map interventional practice across European Society of Cardiology (ESC) member countries. Here we present the main findings of a 16-country survey in which we examine the national availability of interventional infrastructure, human resource, and procedure volumes. METHODS AND RESULTS: Sixteen ESC member countries participated in the EAPCI Atlas survey. Interventional data were collected by the National Cardiac Society of each participating country. An annual median of 5131 [interquartile range (IQR) 4013-5801] diagnostic heart procedures per million people were reported, ranging from <2500 in Egypt and Romania to >7000 in Turkey and Germany. Procedure rates showed significant correlation (r = 0.67, P = 0.013) with gross national income (GNI) per capita. An annual median of 2478 (IQR 1690-2633) percutaneous coronary interventions (PCIs) per million people were reported, ranging from <1000 in Egypt and Romania to >3000 in Switzerland, Poland, and Germany. Procedure rates showed significant correlation with GNI per capita (r = 0.62, P = 0.014). An annual median of 48.2 (IQR 29.1-105.2) transcatheter aortic valve implantation procedures per million people were performed, varying from <25 per million people in Egypt, Romania, Turkey, and Poland to >100 per million people in Denmark, France, Switzerland, and Germany. Procedure rates showed significant correlation with national GNI per capita (r = 0.92, P < 0.001). CONCLUSION: The first report from the EAPCI Atlas has shown considerable international heterogeneity in interventional cardiology procedure volumes. The heterogeneity showed association with national economic resource, a reflection no doubt of the technological costs of developing an interventional cardiology service.

Computed Tomographic Perfusion Imaging for the Prediction of Response and Survival to Transarterial Chemoembolization of Hepatocellular Carcinoma.

BACKGROUND: The purpose of this retrospective cohort study was to evaluate the clinical value of computed tomographic perfusion imaging (CTPI) parameters in predicting the response to treatment and overall survival in patients with hepatocellular carcinoma (HCC) treated with drug-eluting beads transarterial chemoembolization (DEBTACE). PATIENTS AND METHODS: Between December 2010 and January 2013 eighteen patients (17 men, 1 woman; mean age 69 ± 5.8 years) with intermediate stage HCC underwent CTPI of the liver prior to treatment with DEBTACE. Treatment response was evaluated on follow-up imaging according to modified Response Evaluation Criteria in Solid Tumors. Pre-treatment CTPI parameters were compared between patients with complete response and partial response with a Student t-test. We compared survival times with Kaplan-Meier method. RESULTS: CTPI parameters of patients with complete response and others did not show statistical significant difference. The mean survival time was 25.4 ± 3.2 months (95%; CI: 18.7-32.1). Survival was statistically significantly longer in patients with hepatic blood flow (BF) lower than 50.44 ml/100 ml/min (p = 0.033), hepatic blood volume (BV) lower than 13.32 ml/100 ml (p = 0.028) and time to peak (TTP) longer than 19.035 s (p = 0.015). CONCLUSIONS: CTPI enables prediction of survival in patients with intermediate stage HCC, treated with DEBTACE based on the pre-treatment values of BF, BV and TTP perfusion parameters. CT perfusion imaging can't be used to predict treatment response to DEBTACE.

Balloon aortic valvuloplasty (BAV) as a bridge to aortic valve replacement in cancer patients who require urgent non-cardiac surgery.

BACKGROUND: Balloon aortic valvuloplasty (BAV) is a percutaneous treatment option for severe, symptomatic aortic stenosis. Due to early restenosis and failure to improve long term survival, BAV is considered a palliative measure in patients who are not suitable for open heart surgery due to increased perioperative risk. BAV can be used also as a bridge to surgical or transcatheter aortic valve implantation (TAVI) in haemodinamically unstable patients or in patients who require urgent major non-cardiac surgery. PATIENTS AND METHODS: We reported on 6 oncologic patients with severe aortic stenosis that required a major abdominal and gynaecological surgery. In 5 cases we performed BAV procedure alone; in one patient with concomitant coronary artery disease we combined BAV and percutaneous coronary intervention (PCI). RESULTS: With angioplasty and BAV we achieved a good coronary artery flow and an increase in aortic valve area without any periprocedural complications. After the successful procedure, we observed a hemodynamic and symptomatic improvement. As a consequence the operative risk for non-cardiac surgery decreased and the surgical treatment of cancer was done without complications in all the 6 cases. CONCLUSIONS: BAV can be utilized as a part of a complex therapy in severe aortic stenosis aimed to improve the quality of life, decrease the surgical risk for major non-cardiac surgery or as a bridge to surgical or transcatheter aortic valve implantation.

Early unfractionated heparin treatment in patients with STEMI - trial design and rationale.

The early unfractionated heparin (UFH) treatment in patients with ST-elevation myocardial infarction (STEMI) is a single-center, open-label, randomized controlled trial. The study population are patients with STEMI that undergo primary percutaneous coronary intervention (PPCI). The trial was designed to investigate whether early administration of unfractionated heparin immediately after diagnosis of STEMI is beneficial in terms of patency of infarct-related coronary artery (IRA) when compared to established UFH administration at the time of coronary intervention. The patients will be randomized in 1:1 fashion in one of the two groups. The primary efficacy endpoint of the study is Thrombolysis in myocardial infarction (TIMI) flow grades 2 and 3 on diagnostic coronary angiography. Secondary outcome measures are: TIMI flow after PPCI, progression to cardiogenic shock, 30-day mortality, ST-segment resolution, highest Troponin I and Troponin I values at 24 hours. The safety outcome is bleeding complications. The study of early heparin administration in patients with STEMI will address whether pretreatment with UFH can increase the rate of spontaneous reperfusion of infarct-related coronary artery.

In search for "healthy" landing zones for coronary stent placement: are the largest intrasegmental lumens adequate?

Background: Coronary lesions are supposed to be enclosed between proximal and distal reference segments (RSs), the sites with the largest lumens within the same vessel segment. Finding "healthy" landing zones has been fundamental for efficient stent implantation. Consequently, our study aimed to determine, using optical coherence tomography (OCT), to what degree RSs conform to this concept. Methods: Sixty-seven patients with a mean age of 63.5 years underwent culprit lesion stenting due to acute myocardial infarction (MI) (Group 1) or stable angina (Group 2). OCT was performed with commercially available equipment; all evaluations were made at RSs and minimal lumens. Results: Normal vessel wall was infrequent (~10%) at RSs. Acceptable external elastic 220°) occurred in 55% to 67% and in 28% to 31% of RSs, respectively. Tissue composition at RSs was similar in both study groups except for a greater accumulation of thin-cap fibroatheromas (TCFA) in acute MI (29% in Group 1 vs. 9% in Group 2, P=0.035). Flow deterioration after stenting was associated with TCFA clusters extending from culprit main bodies into proximal RSs (P=0.008). Conclusions: Optimal landing zones for stent placement should frequently be searched for beyond the culprit lesion segments although utilizing the largest intrasegmental lumens does not seem to cause immediate harm. However, TCFA at the landings should definitely be avoided.

Outcomes and predictors of left ventricle recovery in patients with severe left ventricular dysfunction undergoing transcatheter aortic valve implantation.

BACKGROUND: Data on the likelihood of left ventricle (LV) recovery in patients with severe LV dysfunction and severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) and its prognostic value are limited. AIMS: We aimed to assess the likelihood of LV recovery following TAVI, examine its association with midterm mortality, and identify independent predictors of LV function. METHODS: In our multicentre registry of 17 TAVI centres in Western Europe and Israel, patients were stratified by baseline LV function (ejection fraction [EF] >/≤30%) and LV response: no LV recovery, LV recovery (EF increase ≥10%), and LV normalisation (EF ≥50% post-TAVI). RESULTS: Our analysis included 10,872 patients; baseline EF was ≤30% in 914 (8.4%) patients and >30% in 9,958 (91.6%) patients. The LV recovered in 544 (59.5%) patients, including 244 (26.7%) patients whose LV function normalised completely (EF >50%). Three-year mortality for patients without severe LV dysfunction at baseline was 29.4%. Compared to this, no LV recovery was associated with a significant increase in mortality (adjusted hazard ratio 1.32; p<0.001). Patients with similar LV function post-TAVI had similar rates of 3-year mortality, regardless of their baseline LV function. Three variables were associated with a higher likelihood of LV recovery following TAVI: no previous myocardial infarction (MI), estimated glomerular filtration rate >60 mL/min, and mean aortic valve gradient (mAVG) (expressed either as a continuous variable or as a binary variable using the standard low-flow, low-gradient aortic stenosis [AS] definition). CONCLUSIONS: LV recovery following TAVI and the extent of this recovery are major determinants of midterm mortality in patients with severe AS and severe LV dysfunction undergoing TAVI. Patients with no previous MI and those with an mAVG >40 mmHg show the best results following TAVI, which are at least equivalent to those for patients without severe LV dysfunction. (ClinicalTrials.gov: NCT04031274).

Characterization and Management of Stable Coronary Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation.

Background/Objectives: To date, data regarding the characteristics and management of obstructive, stable coronary artery disease (CAD) encountered in patients undergoing transcatheter aortic valve implantation (TAVI) are sparse. The aim of the study was to analyze granular details, treatment, and outcomes of patients undergoing TAVI with obstructive, stable CAD from real-world practice. Methods: REVASC-TAVI (Management of myocardial REVASCularization in patients undergoing Transcatheter Aortic Valve Implantation with coronary artery disease) is an investigator-initiated, multicenter registry, which collected data from patients undergoing TAVI with obstructive stable CAD found during the pre-TAVI work-up. Results: A total of 2025 patients from 30 centers worldwide with complete follow-up were included in the registry. Most patients had single-vessel CAD (56.1%). An involvement of proximal coronary tracts was detected in 62.5% of cases, with 12.0% of patients having CAD in left main (LM). Most patients received percutaneous coronary intervention (PCI) (n = 1617, 79.9%), especially those with proximal CAD (90.4%). At 2 years, the rates of all-cause death [Kaplan-Meier (KM) estimates 20.1% vs. 18.8%, plog-rank = 0.86] and of the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure (KM estimates 29.7% vs. 27.5%, plog-rank = 0.82) did not differ between patients undergoing PCI and those who were not. Conclusions: Patients undergoing TAVI with obstructive CAD more commonly had a single-vessel disease and an involvement of proximal coronary tracts. They were commonly treated with PCI, with similar outcomes compared to those treated conservatively.

Impact of the COVID-19 Pandemic on Global TAVR Activity: The COVID-TAVI Study.

BACKGROUND: The COVID-19 pandemic adversely affected health care systems. Patients in need of transcatheter aortic valve replacement (TAVR) are especially susceptible to treatment delays. OBJECTIVES: This study sought to evaluate the impact of the COVID-19 pandemic on global TAVR activity. METHODS: This international registry reported monthly TAVR case volume in participating institutions prior to and during the COVID-19 pandemic (January 2018 to December 2021). Hospital-level information on public vs private, urban vs rural, and TAVR volume was collected, as was country-level information on socioeconomic status, COVID-19 incidence, and governmental public health responses. RESULTS: We included 130 centers from 61 countries, including 65,980 TAVR procedures. The first and second pandemic waves were associated with a significant reduction of 15% (P < 0.001) and 7% (P < 0.001) in monthly TAVR case volume, respectively, compared with the prepandemic period. The third pandemic wave was not associated with reduced TAVR activity. A greater reduction in TAVR activity was observed in Africa (-52%; P = 0.001), Central-South America (-33%; P < 0.001), and Asia (-29%; P < 0.001). Private hospitals (P = 0.005), urban areas (P = 0.011), low-volume centers (P = 0.002), countries with lower development (P < 0.001) and economic status (P < 0.001), higher COVID-19 incidence (P < 0.001), and more stringent public health restrictions (P < 0.001) experienced a greater reduction in TAVR activity. CONCLUSIONS: TAVR procedural volume declined substantially during the first and second waves of the COVID-19 pandemic, especially in Africa, Central-South America, and Asia. National socioeconomic status, COVID-19 incidence, and public health responses were associated with treatment delays. This information should inform public health policy in case of future global health crises.

The Effects of Exercise Training on Exercise Capacity and Vascular Function after Transcatheter Aortic Valve Implantation-A Pilot Study.

Transcatheter aortic valve implantation (TAVI) improves event-free survival in patients with severe aortic stenosis, but patients' exercise capacity remains poor after the procedure. Therefore, we sought to compare the effects of a supervised center-based exercise training program and unsupervised exercise routine on exercise capacity and vascular function in patients after TAVI. Patients were randomized to either center-based exercise training (12-24 sessions of combined aerobic and low-weight resistance training twice weekly for 8-12 weeks) or an unsupervised home-based exercise routine (initial appraisal with detailed recommendations and monthly follow-up). Exercise capacity (cardiopulmonary testing) and vascular function (ultrasonographic measurement of flow-mediated vasodilation (FMD) and arterial stiffness) were assessed at the baseline and after the study period. We included 23 patients (mean age of 81 years, 61% women), with higher-than-expected drop-out rates (41%) because of the coronavirus-19 pandemic outbreak. Exercise capacity improved over time, irrespective of the intervention group: 0.09 mL/min/kg increase in peak oxygen uptake (95% CI [0.01-0.16]; p = 0.02), 8.2 Watts increase in workload (95% CI [0.6-15.8]; p = 0.034), and 47 s increase in cumulative exercise time (95% CI [5.0-89.6]; p = 0.029). A between-group difference in change over time (treatment effect) was detected only for FMD (4.49%; 95% CI [2.35; 6.63], p < 0.001), but not for other outcome variables. Both supervised and unsupervised exercise training improve exercise capacity and vascular function in patients after TAVI, with supervised exercise training possibly yielding larger improvements in vascular function, as determined by FMD.

Effect of Coronary Sinus Reducer Implantation on Aerobic Exercise Capacity in Refractory Angina Patients-A CROSSROAD Study.

Coronary sinus reducer (CSR) implantation is a new treatment option for patients with refractory angina pectoris. However, there is no evidence from a randomized trial that would show an improvement in exercise capacity after this treatment. The aim of this study was to evaluate the influence of CSR treatment on maximal oxygen consumption and compare it to a sham procedure. Twenty-five patients with refractory angina pectoris (Canadian Cardiovascular Society (CCS) class II-IV) were randomized to a CSR implantation (n = 13) or a sham procedure (n = 12). At baseline and after 6 months of follow-up, the patients underwent symptom-limited cardiopulmonary exercise testing with an adjusted ramp protocol and assessment of angina pectoris using the CCS scale and Seattle angina pectoris questionnaire (SAQ). In the CSR group, maximal oxygen consumption increased from 15.56 ± 4.05 to 18.4 ± 5.2 mL/kg/min (p = 0.03) but did not change in the sham group (p = 0.53); p for intergroup comparison was 0.03. In contrast, there was no difference in the improvement of the CCS class or SAQ domains. To conclude, in patients with refractory angina and optimized medical therapy, CSR implantation may improve oxygen consumption beyond that of optimal medical therapy.

Minimally invasive surgical aortic valve replacement versus transfemoral transcatheter aortic valve implantation in low-risk octogenarians : Observational, retrospective and single-center study.

BACKGROUND: The aim of this study was to compare short-term and mid-term outcomes in low-risk octogenarian population treated with transfemoral transcatheter aortic valve implantation (tf-TAVI) or minimally invasive aortic valve replacement (mini-AVR) for severe aortic stenosis. METHODS: In this single-center, retrospective cohort study we gathered data on low-risk (Society of Thoracic Surgeons [STS] score < 4%) octogenarians before and after tf-TAVI and mini-AVR performed between January 2013 and May 2019; follow-up was completed in May 2022. Short-term outcomes were hospital length of stay, in-hospital all-cause mortality and other major postoperative outcomes. Mid-term clinical outcomes were 1­year and 3­year all-cause mortality. Propensity score-based matching was performed. RESULTS: In total 106 patients were matched, resulting in 53 pairs. In-hospital complications were similar between the matched groups of patients with the exception of mild and moderate paravalvular leak (mini-AVR vs. tf-TAVI: mild PVL: 3.8% vs. 45.3%, p < 0.001; moderate PVL: 0% vs. 3.8%, p = 0.4952) and of postprocedural acute kidney injury that was more frequent in mini-AVR group (mini-AVR vs. tf-TAVI: 22.6% vs. 5.7%; p = 0.023). Hospital length of stay (p = 0.239) and in-hospital mortality (p = 0.495) did not differ between groups. The 1-year and 3­year all-cause mortality Kaplan-Meier estimates were similar between mini-AVR and tf-TAVI. CONCLUSION: In the present study on low-risk octogenarians, transfemoral TAVI and minimally invasive AVR showed comparable short-term and mid-term results. Both procedures are deemed safe and effective. Larger RCTs will be required to determine which low-risk patients will benefit most from TAVI.

Case report: A complex case of valve-in-valve TAVI and left bundle branch pacing for severe aortic regurgitation with partially corrected type A aortic dissection and low ejection fraction.

Background: Aortic regurgitation is a major concern following transcatheter aortic valve implantation (TAVI), as even low-grade regurgitation is associated with increased mortality. This is of particular concern to patients with pre-existing aortic disease who are at increased risk of TAVI valve slippage. Furthermore, conduction system disturbances after TAVI, namely left bundle branch block (LBBB), may have an additional detrimental effect on cardiac function. Case presentation: This report documents a successful treatment strategy in a frail patient with a bicuspid aortic valve and aortic disease after valve-sparing surgical repair in 1998, who subsequently developed aortic stenosis and underwent TAVI with an Evolut R self-expanding aortic valve. The progression of aortic disease, aortic root dilatation, and leaflet degeneration over the following years caused aortic regurgitation of the self-expanding aortic valve, resulting in left ventricular dilatation and heart failure along with LBBB and left ventricular (LV) mechanical dyssynchrony. Diagnostic workup of the patient showed persistence of the aneurysm distal to the graft with a dissection spanning the ascending aorta, arch, and terminating proximal to the aortic isthmus. After consideration by the cardiac team, a balloon-expandable valve was chosen for a valve-in-valve (ViV) procedure to provide sufficient radial force to expand the existing valve and correct the regurgitation. Due to the anatomy, a J-wire and pigtail catheter were successfully used for a safe approach and placement of the valve. Following the procedure, intermittent complete atrioventricular block was observed in addition to the pre-existing left bundle branch block, necessitating resynchronization pacing. Due to anatomical considerations, ease of placement, and the expected good level of resynchronization due to the proximal block, we opted for left bundle branch pacing, which showed improvement in left ventricular dyssynchrony and LV function at follow-up. Conclusion: Valve-in-valve implantation of a balloon-expandable Myval TAVI device to treat aortic regurgitation caused by slippage and right leaflet disfunction of slef valve is feasible in challenging anatomical scenarios. Left bundle branch pacing is a viable alternative to correct mechanical dyssynchrony in complex patients with LBBB and anatomical challenges necessitating resynchronization.

Comparison of different percutaneous revascularisation timing strategies in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: The optimal timing to perform percutaneous coronary interventions (PCI) in transcatheter aortic valve implantation (TAVI) patients remains unknown. AIMS: We sought to compare different PCI timing strategies in TAVI patients. METHODS: The REVASC-TAVI registry is an international registry including patients undergoing TAVI with significant, stable coronary artery disease (CAD) at preprocedural workup. In this analysis, patients scheduled to undergo PCI before, after or concomitantly with TAVI were included. The main endpoints were all-cause death and a composite of all-cause death, stroke, myocardial infarction (MI) or rehospitalisation for congestive heart failure (CHF) at 2 years. Outcomes were adjusted using the inverse probability treatment weighting (IPTW) method. RESULTS: A total of 1,603 patients were included. PCI was performed before, after or concomitantly with TAVI in 65.6% (n=1,052), 9.8% (n=157) or 24.6% (n=394), respectively. At 2 years, all-cause death was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (6.8% vs 20.1% vs 20.6%; p<0.001). Likewise, the composite endpoint was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (17.4% vs 30.4% vs 30.0%; p=0.003). Results were confirmed at landmark analyses considering events from 0 to 30 days and from 31 to 720 days. CONCLUSIONS: In patients with severe aortic stenosis and stable coronary artery disease scheduled for TAVI, performance of PCI after TAVI seems to be associated with improved 2-year clinical outcomes compared with other revascularisation timing strategies. These results need to be confirmed in randomised clinical trials.

Double venous drainage through the superior vena cava in minimally invasive aortic valve replacement: a retrospective study.

AIM: To compare the outcomes of patients who underwent upper mini-sternotomy or right mini-thoracotomy and those who underwent full sternotomy and to report a technical improvement in venous drainage by means of double venous cannulation of the superior vena cava (SVC) in mini surgical procedures. METHODS: We retrospectively analyzed the outcome of 217 patients who underwent aortic valve replacement through upper mini-sternotomy or right mini-thoracotomy at the Department of Cardiovascular Surgery, University Medical Centre Ljubljana, Slovenia from 1996 till 2010. Cannulation of SVC and right atrial appendage was performed in 142/217 (65%) patients, while in the remaining 75 (35%) patients, double cannulation of SVC was used for venous drainage. The results of patients who underwent mini approaches were compared to 236 patients who underwent full sternotomy for the same purpose from 2009 to 2010 at the same center. RESULTS: We found a shorter mean length of intensive care unit stay, less volume chest-tube drainage, shorter crossclamp and cardio pulmonary bypass times, and less postoperative permanent pacemaker implantations in the minimally invasive group patients than in full sternotomy group patients. Using double cannulation of the SVC for venous drainage made venous cannulation in mini approaches easier and eliminated the need for obtaining femoral venous access. CONCLUSION: Our study confirmed that even though technically challenging, upper mini-sternotomy and right mini-thoracotomy approaches for aortic valve replacement have potential advantages over conventional median sternotomy. They were proved to be safe, efficacious, and can significantly reduce surgical trauma and are therefore particularly valuable in some higher risk, obese, diabetic and elderly patients. Using double cannulation of SVC for venous drainage made venous cannulation easier and eliminated the need for obtaining femoral venous access.