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.

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).

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.

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.

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.

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.

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.

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.

Management of Myocardial Revascularization in Patients With Stable Coronary Artery Disease Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: The best management of stable coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is still unclear due to the marked inconsistency of the available evidence. METHODS: The REVASC-TAVI registry (Management of Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation With Coronary Artery Disease) collected data from 30 centers worldwide on patients undergoing TAVI who had significant, stable CAD at preprocedural work-up. For the purposes of this analysis, patients with either complete or incomplete myocardial revascularization were compared in a propensity score matched analysis, to take into account of baseline confounders. The primary and co-primary outcomes were all-cause death and the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure, respectively, at 2 years. RESULTS: Among 2407 patients enrolled, 675 pairs of patients achieving complete or incomplete myocardial revascularization were matched. The primary (21.6% versus 18.2%, hazard ratio' 0.88 [95% CI, 0.66-1.18]; P=0.38) and co-primary composite (29.0% versus 27.1%, hazard ratio' 0.97 [95% CI, 0.76-1.24]; P=0.83) outcome did not differ between patients achieving complete or incomplete myocardial revascularization, respectively. These results were consistent across different prespecified subgroups of patients (< or >75 years of age, Society of Thoracic Surgeons score > or <4%, angina at baseline, diabetes, left ventricular ejection fraction > or <40%, New York Heart Association class I/II or III/IV, renal failure, proximal CAD, multivessel CAD, and left main/proximal anterior descending artery CAD; all P values for interaction >0.10). CONCLUSIONS: The present analysis of the REVASC-TAVI registry showed that, among TAVI patients with significant stable CAD found during the TAVI work-up, completeness of myocardial revascularization achieved either staged or concomitantly with TAVI was similar to a strategy of incomplete revascularization in reducing the risk of all cause death, as well as the risk of death, stroke, myocardial infarction, and rehospitalization for heart failure at 2 years, regardless of the clinical and anatomical situations.

Similar clinical outcomes with transcatheter aortic valve implantation and surgical aortic valve replacement in octogenarians with aortic stenosis.

Background: Transcatheter aortic valve implantation (TAVI) is the preferred treatment option for severe aortic stenosis in the elderly and in patients with comorbidities. We sought to compare outcomes after TAVI and surgical aortic valve replacement (SAVR) in octogenarians. Methods: In this retrospective cohort study conducted at our tertiary center, clinical data were gathered before and after TAVI and SAVR procedures performed from January 2013 to May 2019; follow-up completed in March 2021. The primary outcome was 1-year mortality. Patients were stratified according to Society of Thoracic Surgeons (STS) score and procedure type. Propensity score-based matching was also performed. Results: Of 542 patients who matched the inclusion criteria, 273 underwent TAVI and 269 SAVR. TAVI patients were older (85.8 ± 3.0 vs. 82.2 ± 2.2 years; P < 0.001) and had a higher mean STS score (5.0 ± 4.0 vs. 2.8 ± 1.3; P < 0.001) and EuroSCORE II (5.3 ± 4.1 vs. 2.8 ± 6.0; P < 0.001). Rates of postoperative permanent pacemaker insertion (15.0% vs. 9.3%; P = 0.040) and paravalvular leak (9.9% vs. 0.8%; P < 0.001) were higher and acute kidney injury lower (8.8% vs. 32.7%; P < 0.001) after TAVI, with no difference between treatment groups for major bleeding (11.0% vs. 6.7%; P = 0.130) or 30-day mortality (5.5% vs. 3.7%; P = 0.315). A statistically significant difference was found between TAVI and SAVR in low- and intermediate-risk groups when it came to occurrence of paravalvular leak, acute kidney injury, and new onset AF (all P < 0.001). Conclusion: This analysis of an octogenarian "real-life" population undergoing TAVI or SAVR (with a biological valve) showed similar outcomes regarding clinical endpoints in low- and medium-risk (STS score) groups.

Edge-to-Edge Repair for Tricuspid Valve Regurgitation. Preliminary Echo-Data and Clinical Implications from the Tricuspid Regurgitation IMAging (TRIMA) Study.

Background: The natural history of tricuspid valve regurgitation (TR) is characterized by poor prognosis and high in-hospital mortality when treated with isolated surgery. We report the preliminary echocardiographic and procedural results of a prospective cohort of symptomatic patients with high to prohibitive surgical risk and at least severe TR who underwent transcatheter edge-to-edge repair through the TriClipTM system. Methods: From June 2020 to March 2022, 27 consecutive patients were screened, and 13 underwent transcatheter TriClipTM repair. In-hospital, 30-day and six-month clinical and echocardiographic outcomes were collected. Results: Nine patients had severe, three massive and one baseline torrential TR. Sustained TR reduction of ≥1 grade was achieved in all patients, of which 90% reached a moderate TR or less. On transthoracic echocardiographic examination, there were significant reductions in vena contracta width (p < 0.001), effective regurgitant orifice area (p < 0.001) and regurgitant volume (p < 0.001) between baseline and hospital discharge. We also observed a significant reduction in tricuspid annulus diameter (p < 0.001), right ventricular basal diameter (p = 0.001) and right atrial area (p = 0.026). Conclusion: Treatment with the edge-to-edge TriClip device is safe and effective. The resulting echocardiographic improvements indicate tricuspid valve leaflet approximation does not just significantly reduce the grade of TR but also affects adjacent structures and improves right ventricular afterload adaptation.

Technical Aspects and Development of Transcatheter Aortic Valve Implantation.

Aortic stenosis is the most common valve disease requiring surgery or percutaneous treatment. Since the first-in-man implantation in 2002 we have witnessed incredible progress in transcatheter aortic valve implantation (TAVI). In this article, we review the technical aspects of TAVI development with a look at the future. Durability, low thrombogenicity, good hydrodynamics, biocompatibility, low catheter profile, and deployment stability are the attributes of an ideal TAVI device. Two main design types exist-balloon-expandable and self-expanding prostheses. Balloon-expandable prostheses use a cobalt-chromium alloy frame providing high radial strength and radiopacity, while the self-expanding prostheses use a nickel-titanium (Nitinol) alloy frame, which expands to its original shape once unsheathed and heated to the body temperature. The valve is sewn onto the frame and consists of the porcine or bovine pericardium, which is specially treated to prevent calcinations and prolong durability. The lower part of the frame can be covered by polyethylene terephthalate fabric or a pericardial skirt, providing better sealing between the frame and aortic annulus. The main future challenges lie in achieving lower rates of paravalvular leaks and new pacemaker implantations following the procedure, lower delivery system profiles, more precise positioning, longer durability, and a good hemodynamic profile. Patient-specific design and the use of autologous tissue might solve these issues.

Transcatheter Aortic Valve Implantation: A Report on Serbia's First Systematic Program.

Introduction: Severe aortic stenosis, a highly-common valve disease in the elderly, has a poor prognosis if left untreated. To address the concern of effective procedures for severe aortic stenosis, a systematic TAVI program was established at the Dedinje Cardiovascular Institute (Belgrade, Serbia). Methods: Our cohort was composed of 56 patients (74±15 years old). The mean logistic EuroScore was 10.17%; the mean Society of Thoracic Surgeons score was 3.22%. One third of the patients were categorized as class III or IV of the New York Heart Association (NYHA). The valves selected for use were either self-expandable or balloon expandable (Evolut R, Medtronic; Acurate Neo, Boston Scientific and Myval, Meril). The choice of valve type was made by the Institute's Structural Heart Team, in accordance with the patient's native aortic valve, size and calcification of ilio-femoral vessels, as well as the need for alternative access. TAVI procedure was conducted according to current guidelines provided by the European Society of Cardiology. Results: The procedure success rate was 100%. Trans-femoral approach was achieved in 100% of patients; percutaneously in 87.5%, while a surgical cut was necessary in 12.5%. No patient showed moderate or severe aortic regurgitation after the procedure, although trace or mild regurgitation was recorded in 30.3%. Permanent pacemaker was implanted in one patient (1.78%), contrast induced acute kidney injury occured in one patient (1.78%), no stroke was recorded, and three pseudo-aneurysms which required surgical intervention occurred. Three patients required blood transfusions (5.33%). A 30-day all-cause mortality rate was 1.78%. Conclusion: The Dedinje Cardiovascular Institute spearheaded all efforts to establish a TAVI program in Serbia. Our initial TAVI results are promising, encouraging, and comparable with the results of previous large randomized trials. This initial experience opens the door for further development with a goal of our Institute to become a high-volume TAVI center.

Center Valve Preference and Outcomes of Transcatheter Aortic Valve Replacement: Insights From the AMTRAC Registry.

BACKGROUND: Data on outcomes of transcatheter aortic valve replacement (TAVR) using balloon-expandable valves (BEVs) or self-expandable valves (SEVs) as well as the impact of center valve preference on these outcomes are limited. OBJECTIVES: The aim of this study was to compare outcomes of TAVR procedures using third-generation BEVs and SEVs stratified by center valve preference. METHODS: In a multicenter registry (n = 17), 13 centers exhibited valve preference (66.6%-90% of volume) and were included. Outcomes were compared between BEVs and SEVs stratified by center valve preference. RESULTS: In total, 7,528 TAVR procedures (3,854 with SEVs and 3,674 with BEVs) were included. The mean age was 81 years, and the mean Society of Thoracic Surgeons score was 5.2. Baseline characteristics were similar between BEVs and SEVs. Need for pacemaker implantation was higher with SEVs at BEV- and SEV-dominant centers (17.8% vs 9.3% [P < 0.001] and 12.7% vs 10.0% [P = 0.036], respectively; HR: 1.51; P for interaction = 0.021), risk for cerebrovascular accident was higher with SEVs at BEV-dominant but not SEV-dominant centers (3.6% vs 1.1% [P < 0.001] and 2.2% vs 1.4% [P = 0.162]; HR: 2.08; P for interaction < 0.01). Aortic regurgitation greater than mild was more frequent with SEVs at BEV-dominant centers and similar with BEVs regardless of center dominance (5.2% vs 2.8% [P < 0.001] and 3.4% vs 3.7% [P = 0.504], respectively). Two-year mortality was higher with SEVs at BEV-dominant centers but not at SEV-dominant centers (21.9% vs 16.9% [P = 0.021] and 16.8% vs 16.5% [P = 0.642], respectively; HR: 1.20; P for interaction = 0.032). CONCLUSIONS: Periprocedural outcomes, aortic regurgitation greater than mild, and 2-year mortality are worse when TAVR is performed using SEVs at BEV-dominant centers. Outcomes are similar regardless of valve type at SEV-dominant centers. The present results stress the need to account for this factor when comparing BEV and SEV outcomes. (The Aortic+Mitral Transcatheter [AMTRAC] Valve Registry; NCT04031274).

Valve-in-Valve Transcatheter Aortic Valve Implantation With Acute Left and Right Coronary Artery Occlusion: A Case Report.

Acute coronary artery occlusion is a relatively rare procedural adverse event in valve-in-valve transcatheter aortic valve implantation. Here we present a case of a 26-mm Sapien 3 prosthetic valve implantation in a degenerated 23-mm Freedom Solo bioprosthetic surgical valve with subsequent left and right coronary occlusion. Left coronary artery occlusion was managed immediately with the use of an upfront coronary artery protection technique and drug-eluting stent placement. Right coronary artery occlusion presented with right-sided heart failure and cardiac arrest that required resuscitation and additional hemodynamic support. As the artery could not be engaged with a catheter, a combination of intravenous antithrombotic and anticoagulant therapy was used as a successful bailout step to restore adequate coronary flow.

Clinical outcomes of transcatheter aortic valve implantation in patients younger than 70 years rejected for surgery: the AMTRAC registry.

BACKGROUND: The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing. AIMS: The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients <70 years old. METHODS: All patients undergoing TAVI (n=8,626) from the 18 participating centres between January 2007 and June 2020 were stratified by age (70). For patients <70, the indications for TAVI were extracted from Heart Team discussions and the baseline characteristics and mortality were compared between the two groups. RESULTS: Overall, 640 (7.4%) patients were <70 (9.1% during 2018-2020, p<0.001); the mean age was 65.0±2.3 years. The younger patients were more often male, with bicuspid valves or needing valve-in-valve procedures. They had a higher prevalence of lung disease and diabetes. In 80.7% of cases, the Heart Team estimated an increased surgical risk and TAVI was selected, reflected by an STS score >4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the <70 and >70 groups. In the <70 group, mortality was higher for those referred for TAVI due to an increased surgical risk compared to those referred for other reasons (31.6 vs 24.5%, HR 1.23, p=0.021). Mortality was similar regardless of the STS stratum in patients judged by the Heart Team to be at increased surgical risk (32.6 vs 30.4%, HR 0.98, p=0.715). CONCLUSIONS: Use of TAVI in patients <70 is becoming more frequent. The main reason for choosing TAVI is due to an increased surgical risk not adequately represented by the STS score. The outcomes for these patients are similar to those for older TAVI patients. Dedicated trials of TAVI/SAVR in younger patients are needed to guide decisions concerning expansion of TAVI indications. ((ClinicalTrials.gov: NCT04031274).

Efficacy of coronary sinus reducer implantation in patients with chronic total occlusion of the right coronary artery.

BACKGROUND: Clinical efficacy of coronary sinus reducer (CSR) in refractory angina (RA) patients with ischemia due to the chronic total occlusion (CTO) of the right coronary artery (RCA) remains unknown. AIMS: To evaluate the efficacy of CSR implantation in RA patients with CTO RCA and compare them to CSR recipients with left coronary artery (LCA) ischemia. METHODS: Consecutive patients with CTO RCA from 2 centers were prospectively included and compared to patients with LCA ischemia. All patients underwent evaluation of angina severity and quality of life (QoL) at baseline and after 12 months. In a subgroup of CTO RCA patients, stress cardiac magnetic resonance (CMR) imaging was also performed. RESULTS: Twenty-two patients with CTO RCA and predominant inferior and/or inferoseptal wall ischemia (the CTO RCA group) were compared to 24 patients with predominant anterior, lateral, and/or anteroseptal wall ischemia (the LCA group). While the Canadian Cardiovascular Society (CCS) anginascore mean (SD) improved in the CTO RCA group from 2.73 (0.46) to 1.82 (0.73) (P <0.001) and in the LCA group from 2.67 (0.57) to 1.92 (0.72) (P <0.001), there was no intergroup difference (P = 0.350). Significant improvement in all domains of the Seattle Angina Questionnaire was observed. Stress CMR did not show a significant reduction of ischemic inferior and/or inferoseptal segments, however, improvements in the transmurality index (P = 0.03) and the myocardial perfusion reserve index in segments with inducible ischemia (P = 0.03) were observed in the CTO RCA group. CONCLUSIONS: In CTO RCA patients, CSR implantation alleviated angina symptoms and improved QoL. The extent of improvement was comparable to that observed in patients with LCA ischemia.

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.