BACKGROUND: Patients with severe aortic stenosis present frequently (∼50%) with concomitant obstructive coronary artery disease. Current guidelines recommend combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) as the preferred treatment. Transcatheter aortic valve implantation (TAVI) and fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) represent a valid treatment alternative. We aimed to test the non-inferiority of FFR-guided PCI plus TAVI versus SAVR plus CABG in patients with severe aortic stenosis and complex coronary artery disease. METHODS: This international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial was conducted at 18 tertiary medical centres across Europe. Patients (aged ≥70 years) with severe aortic stenosis and complex coronary artery disease, deemed feasible for percutaneous or surgical treatment according to the on-site Heart Team, were randomly assigned (1:1) to FFR-guided PCI plus TAVI or SAVR plus CABG according to a computer-generated sequence with random permuted blocks sizes stratified by site. The primary endpoint was a composite of all-cause mortality, myocardial infarction, disabling stroke, clinically driven target-vessel revascularisation, valve reintervention, and life-threatening or disabling bleeding at 1 year post-treatment. The trial was powered for non-inferiority (with a margin of 15%) and if met, for superiority. The primary and safety analyses were done per an intention-to-treat principle. This trial is registered with ClinicalTrials.gov (NCT03424941) and is closed. FINDINGS: Between May 31, 2018, and June 30, 2023, 172 patients were enrolled, of whom 91 were assigned to the FFR-guided PCI plus TAVI group and 81 to the SAVR plus CABG group. The mean age of patients was 76·5 years (SD 3·9). 118 (69%) of 172 patients were male and 54 (31%) patients were female. FFR-guided PCI plus TAVI resulted in favourable outcomes for the primary endpoint (four [4%] of 91 patients) versus SAVR plus CABG (17 [23%] of 77 patients; risk difference -18·5 [90% CI -27·8 to -9·7]), which was below the 15% prespecified non-inferiority margin (pnon-inferiority<0·001). FFR-guided PCI plus TAVI was superior to SAVR plus CABG (hazard ratio 0·17 [95% CI 0·06-0·51]; psuperiority<0·001), which was driven mainly by all-cause mortality (none [0%] of 91 patients vs seven (10%) of 77 patients; p=0·0025) and life-threatening bleeding (two [2%] vs nine [12%]; p=0·010). INTERPRETATION: The TCW trial is the first trial to compare percutaneous treatment versus surgical treatment in patients with severe aortic stenosis and complex coronary artery disease, showing favourable primary endpoint and mortality outcomes with percutaneous treatment. FUNDING: Isala Heart Centre and Medtronic.
- MeSH
- aortální stenóza * chirurgie komplikace MeSH
- chirurgická náhrada chlopně metody MeSH
- frakční průtoková rezerva myokardu * MeSH
- koronární angioplastika * metody MeSH
- koronární bypass * metody MeSH
- lidé MeSH
- nemoci koronárních tepen * chirurgie komplikace terapie MeSH
- prospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- transkatetrální implantace aortální chlopně * metody MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- hodnocení ekvivalence MeSH
- multicentrická studie MeSH
- srovnávací studie MeSH
BACKGROUND AND AIMS: The question of when and how to treat truly asymptomatic patients with severe aortic stenosis (AS) and normal left ventricular (LV) systolic function is still subject to debate and ongoing research. Here, the results of extended follow-up of the AVATAR trial are reported (NCT02436655, ClinicalTrials.gov). METHODS: The AVATAR trial randomly assigned patients with severe, asymptomatic AS and LV ejection fraction ≥ 50% to undergo either early surgical aortic valve replacement (AVR) or conservative treatment with watchful waiting strategy. All patients had negative exercise stress testing. The primary hypothesis was that early AVR will reduce a primary composite endpoint comprising all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failure (HF), as compared with conservative treatment strategy. RESULTS: A total of 157 low-risk patients (mean age 67 years, 57% men, mean Society of Thoracic Surgeons score 1.7%) were randomly allocated to either the early AVR group (n = 78) or the conservative treatment group (n = 79). In an intention-to-treat analysis, after a median follow-up of 63 months, the primary composite endpoint outcome event occurred in 18/78 patients (23.1%) in the early surgery group and in 37/79 patients (46.8%) in the conservative treatment group [hazard ratio (HR) early surgery vs. conservative treatment 0.42; 95% confidence interval (CI) 0.24-0.73, P = .002]. The Kaplan-Meier estimates for individual endpoints of all-cause death and HF hospitalization were significantly lower in the early surgery compared with the conservative group (HR 0.44; 95% CI 0.23-0.85, P = .012, for all-cause death and HR 0.21; 95% CI 0.06-0.73, P = .007, for HF hospitalizations). CONCLUSIONS: The extended follow-up of the AVATAR trial demonstrates better clinical outcomes with early surgical AVR in truly asymptomatic patients with severe AS and normal LV ejection fraction compared with patients treated with conservative management on watchful waiting.
- MeSH
- aortální chlopeň chirurgie MeSH
- aortální stenóza * chirurgie mortalita terapie MeSH
- asymptomatické nemoci terapie MeSH
- avatar MeSH
- cévní mozková příhoda MeSH
- chirurgická náhrada chlopně * metody MeSH
- hospitalizace statistika a číselné údaje MeSH
- konzervativní terapie * metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- pozorné vyčkávání MeSH
- senioři MeSH
- tepový objem fyziologie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
BACKGROUND AND AIMS: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries. METHODS: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety. RESULTS: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60 min; P < .001) and intervention times (85 vs. 95 min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%). CONCLUSIONS: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.
- MeSH
- aortální stenóza * chirurgie MeSH
- benchmarking * MeSH
- bezpečnost pacientů MeSH
- délka pobytu * statistika a číselné údaje MeSH
- kritické cesty MeSH
- lidé MeSH
- pooperační komplikace epidemiologie prevence a kontrola MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- transkatetrální implantace aortální chlopně * metody MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- Geografické názvy
- Evropa MeSH
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is increasingly being used in younger patients and those with lower peri-procedural risk, meaning more patients will live long enough to experience structural valve deterioration (SVD) of the bioprosthesis, indicating repeated TAVI. Experience of repeated TAVI-transcatheter heart valve (THV) implantation into an index THV is limited. This registry aims to assess the peri-procedural and short-term safety, efficacy and durability of repeated TAVI. METHODS: The ReTAVI Prospective observational registry is an investigator-initiated, multicentre, international, prospective registry of patients undergoing repeated TAVI using balloon-expandable SAPIEN prosthesis to evaluate procedural and short-term safety, efficacy and durability as well as anatomical and procedural factors associated with optimal results. The registry will enrol at least 150 patients across 60 high-volume centres. Patients must be ≥18 years old, have had procedural success with their first TAVI, have index THV device failure, intend to undergo repeated TAVI and be considered suitable candidates by their local Heart Team. All patients will undergo a 30-day and 12-month follow-up. The estimated study completion is 2025. CONCLUSIONS: The registry will collect pre-, peri-, postoperative and 12-months data on patients undergoing repeated TAVI procedures with THVs for failure of the index THV and determine VARC-3-defined efficacy and safety at 30 days and functional outcome at 12 months. The registry will expand existing data sets and identify patient characteristics/indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis.
- MeSH
- aortální stenóza * chirurgie MeSH
- lidé MeSH
- prospektivní studie MeSH
- registrace * MeSH
- selhání protézy MeSH
- senioři MeSH
- srdeční chlopně umělé MeSH
- transkatetrální implantace aortální chlopně * metody MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
Pure aortic regurgitation and dilation of aortic annulus are the most significant risk factors for the failure of pulmonary autograft after the Ross procedure. Aortic annuloplasty has a positive effect on the durability of the autograft. Previously, we described a technique for external annuloplasty with dedicated CORONEO ring. In the present manuscript, we suggest the sizing of annuloplasty based on the diameter of pulmonary autograft annulus.
- MeSH
- aortální chlopeň diagnostické zobrazování chirurgie MeSH
- aortální insuficience * diagnostické zobrazování chirurgie etiologie MeSH
- aortální stenóza * chirurgie MeSH
- autologní štěp MeSH
- autologní transplantace škodlivé účinky MeSH
- lidé MeSH
- následné studie MeSH
- plicní chlopeň * transplantace MeSH
- reoperace škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
OBJECTIVE: Management of patients with severe aortic stenosis (AS) may differ according to the patient sex. This study aimed to describe patterns of aortic valve replacement (AVR) for severe AS across Europe, including stratification by sex. METHODS: Procedure volume data for surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) for six years (2015-2020) were extracted from national databases for Austria, Czech Republic, Denmark, England, Finland, France, Germany, Norway, Poland, Spain, Sweden, and Switzerland and stratified by sex. Patients per million population (PPM) undergoing AVR per year were calculated using population estimates from Eurostat. RESULTS: Between 2015 and 2019, AVR procedures grew at an average annual rate of 3.9%. In 2020, the average total PPM undergoing AVR across all countries was 339, with 51% of procedures being TAVI and 49% SAVR. AVR PPM varied widely between countries, with the highest and lowest in Germany and Poland, respectively. The average total PPM was higher for men than women (423 vs. 258), but a higher proportion of women (62%) than men (44%) received TAVI. The proportion of TAVI among total AVR procedures increased with age, with an overall average of 96% of men and 98% of women aged ≥85 years receiving TAVI; however, adoption of TAVI varied by country. CONCLUSIONS: The analysis of temporal trends in the adoption of TAVI vs. SAVR across Europe showed significant variations. Despite the higher use of TAVI vs. SAVR in women, overall rates of AV intervention in women were lower compared to men.
- MeSH
- aortální chlopeň chirurgie MeSH
- aortální stenóza * chirurgie epidemiologie MeSH
- chirurgická náhrada chlopně trendy statistika a číselné údaje MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- sexuální faktory MeSH
- transkatetrální implantace aortální chlopně trendy statistika a číselné údaje MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- Geografické názvy
- Evropa MeSH
Valvular heart disease leads to ventricular pressure and/or volume overload. Pressure overload leads to fibrosis, which might regress with its resolution, but the limits and details of this reverse remodeling are not known. To gain more insight into the extent and nature of cardiac fibrosis in valve disease, we analyzed needle biopsies taken from the interventricular septum of patients undergoing surgery for valve replacement focusing on the expression and distribution of major extracellular matrix protein involved in this process. Proteomic analysis performed using mass spectrometry revealed an excellent correlation between the expression of collagen type I and III, but there was little correlation with the immunohistochemical staining performed on sister sections, which included antibodies against collagen I, III, fibronectin, sarcomeric actin, and histochemistry for wheat germ agglutinin. Surprisingly, the immunofluorescence intensity did not correlate significantly with the gold standard for fibrosis quantification, which was performed using Picrosirius Red (PSR) staining, unless multiplexed on the same tissue section. There was also little correlation between the immunohistochemical markers and pressure gradient severity. It appears that at least in humans, the immunohistochemical pattern of fibrosis is not clearly correlated with standard Picrosirius Red staining on sister sections or quantitative proteomic data, possibly due to tissue heterogeneity at microscale, comorbidities, or other patient-specific factors. For precise correlation of different types of staining, multiplexing on the same section is the best approach.
- MeSH
- aortální insuficience metabolismus patologie chirurgie MeSH
- aortální stenóza * metabolismus patologie chirurgie MeSH
- extracelulární matrix - proteiny * metabolismus analýza MeSH
- fibróza * metabolismus patologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mezikomorová přepážka patologie metabolismus MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is one of the most significant inventions in cardiology, as it provides a viable minimally invasive treatment option for patients with aortic stenosis, the most common valvular disease in the developed world and one with a poor prognosis when left untreated. Using data available to date, this review aims to discuss and identify possible predictors of TAVI valve durability - an essential requirement for the device's wide-spread use, especially in younger patients. AREAS COVERED: This article explores the main causes of bioprosthetic valve dysfunction (BVD) based on pathophysiology and available data, and reviews possible predictors of BVD including prosthesis-related, procedure-related, and patient-related factors. An emphasis is made on affectable predictors, which could potentially be targeted with prevention management and improve valve durability. A literature search of online medical databases was conducted using relevant key words and dates; significant clinical trials were identified. A brief overview of important randomized controlled trials with mid to long-term follow-up is included in this article. EXPERT OPINION: Identifying modifiable predictors of valve dysfunction presents an opportunity to enhance and predict valve durability - a necessity as patients with longer life-expectancies are being considered for the procedure.
- MeSH
- aortální chlopeň chirurgie MeSH
- aortální stenóza * chirurgie MeSH
- bioprotézy * MeSH
- lidé MeSH
- selhání protézy MeSH
- srdeční chlopně umělé * MeSH
- transkatetrální implantace aortální chlopně * škodlivé účinky metody MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
BACKGROUND: Patients with severe aortic stenosis (AS) frequently present with concomitant obstructive coronary artery disease (CAD). In those, current guidelines recommend combined coronary artery bypass grafting (CABG) and surgical aortic valve replacement (SAVR) as the preferred treatment option, although this surgical approach is associated with a high rate of clinical events. Combined transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) with or without FFR have evolved as a valid alternative for cardiac surgery in patients with AS and multivessel or advanced CAD. To date, no dedicated trial has prospectively evaluated the outcomes of a percutaneous versus surgical treatment for patients with both severe AS and CAD. AIMS: To investigate whether fractional-flow reserve (FFR)-guided PCI and TAVI is noninferior to combined CABG and SAVR for the treatment of severe AS and multivessel or advanced CAD. METHODS: The Transcatheter Valve and Vessels (TCW) trial (clinicaltrial.gov: NCT03424941) is a prospective, randomized, controlled, open label, international trial. Patients ≥ 70 years with severe AS and multivessel (≥ 2 vessels) or advanced CAD, deemed feasible by the heart team for both; a full percutaneous or surgical treatment, will be randomised in a 1:1 fashion to either FFR-guided PCI followed by TAVI (intervention arm) vs. CABG and SAVR (control arm). The primary endpoint is a patient-oriented composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve reintervention, and life threatening or disabling bleeding at 1 year. The TCW trial is powered for noninferiority, and if met, superiority will be tested. Assuming a primary endpoint rate of 30% in the CABG-SAVR arm, with a significance level α of 5%, a noninferiority limit delta of 15% and a loss to follow-up of 2%, a total of 328 patients are needed to obtain a power of 90%. The primary endpoint analysis is performed on an intention-to-treat basis. SUMMARY: The TCW Trial is the first prospective randomized trial that will study if a less invasive percutaneous treatment for severe AS and concomitant advanced CAD (i.e., FFR-guided PCI-TAVI) is noninferior to the guidelines recommended approach (CABG-SAVR).
- MeSH
- aortální chlopeň chirurgie MeSH
- aortální stenóza * komplikace diagnóza chirurgie MeSH
- frakční průtoková rezerva myokardu * MeSH
- koronární angioplastika * škodlivé účinky MeSH
- koronární bypass MeSH
- lidé MeSH
- nemoci koronárních tepen * komplikace diagnóza chirurgie MeSH
- prospektivní studie MeSH
- transkatetrální implantace aortální chlopně * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
PURPOSE: Left ventricular myocardial work (LVMW) has been shown to better characterize LV function in patients with severe aortic stenosis by correcting LV afterload. The aim of this study was to evaluate the evolution in LVMW indices after transcatheter aortic valve replacement (TAVR) and their prognostic value. METHODS: The following LVMW indices were calculated before and immediately after TAVR in 255 patients (median age 82 years, 51% male): global work index (GWI), global constructive work (GCW), global wasted work (GWW) and global work efficiency (GWE). The study endpoint was all-cause mortality. RESULTS: After TAVR, LV ejection fraction and LV global longitudinal strain (GLS) did not change significantly (from 56% to 55%, p = 0.470 and from 13.6% to 13.2%, p = 0.068). Concerning LVMW indices, while LV GWW remained unchanged after TAVR (from 247 to 258 mmHg%, p = 0.080), LV GWI, LV GCW, and LV GWE significantly decreased (from 1882 to 1291 mmHg%, p < 0.001, from 2248 to 1671 mmHg%, p < 0.001, and from 89% to 85%, p < 0.001, respectively). During a median follow-up of 59 [40-72] months, 129 patients died. After correcting for potential confounders (sex, diabetes, renal function, atrial fibrillation, Charlson comorbidity index, and pacemaker implantation post-TAVR), post-TAVR LV GLS, GWI, and GCW remained independently associated with all-cause mortality. However, post-TAVR LV GWI demonstrated the highest increase in model predictivity. CONCLUSION: In patients undergoing TAVR, LVMW parameters significantly change after intervention. LV GWI after TAVR showed the strongest association with all-cause mortality among both conventional and advanced parameters of LV systolic function both pre- and post-TAVR and might enable better risk stratification of these patients after intervention.
- MeSH
- aortální stenóza * chirurgie patofyziologie komplikace MeSH
- dysfunkce levé srdeční komory patofyziologie diagnostické zobrazování etiologie MeSH
- echokardiografie metody MeSH
- funkce levé komory srdeční fyziologie MeSH
- lidé MeSH
- prognóza MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdeční komory diagnostické zobrazování patofyziologie MeSH
- stupeň závažnosti nemoci MeSH
- tepový objem fyziologie MeSH
- transkatetrální implantace aortální chlopně * metody MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH