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
OBJECTIVES: Both aortic root remodelling and aortic valve (AV) reimplantation have been used for valve-sparing root replacement in patients with aortic root aneurysm with or without aortic regurgitation. There is no clear evidence to support one technique over the another. This study aimed to compare remodelling with basal ring annuloplasty versus reimplantation on a multicentre level with the use of propensity-score matching. METHODS: This was a retrospective international multicentre study of patients undergoing remodelling or reimplantation between 2010 and 2021. Twenty-three preoperative covariates (including root dimensions and valve characteristics) were used for propensity-score matching. Perioperative outcomes were analysed along with longer-term freedom from AV reoperation/reintervention and other major valve-related events. RESULTS: Throughout the study period, 297 patients underwent remodelling and 281 had reimplantation. Using propensity-score matching, 112 pairs were selected and further compared. We did not find a statistically significant difference in perioperative outcomes between the matched groups. Patients after remodelling had significantly higher reintervention risk than after reimplantation over the median follow-up of 6 years (P = 0.016). The remodelling technique (P = 0.02), need for decalcification (P = 0.03) and degree of immediate postoperative AV regurgitation (P < 0.001) were defined as independent risk factors for later AV reintervention. After exclusion of patients with worse than mild AV regurgitation immediately after repair, both techniques functioned comparably (P = 0.089). CONCLUSIONS: AV reimplantation was associated with better valve function in longer-term postoperatively than remodelling. If optimal immediate repair outcome was achieved, both techniques provided comparable AV function.
- MeSH
- anuloplastika srdeční chlopně metody MeSH
- aortální chlopeň * chirurgie MeSH
- aortální insuficience * chirurgie MeSH
- chirurgická náhrada chlopně metody MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- reoperace statistika a číselné údaje MeSH
- replantace * metody MeSH
- retrospektivní studie MeSH
- senioři MeSH
- tendenční skóre * MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- srovnávací studie MeSH
Remodelácia aortálneho koreňa bola po prvý krát publikovaná v 80. rokoch minulého storočia. Dnešná remodelácia koreňa aorty je geometricky presne definovaná a indikovaná u každého pacienta s regurgitáciou aortálnej chlopne pri aneuryzme koreňa aorty. Cieľom práce je zhodnotiť strednedobé výsledky remodelácie koreňa aorty v našich podmienkach a rizikové faktory, ktoré majú na túto stabilitu vplyv. Do súboru bolo zaradených 103 pacientov podstupujúcich remodeláciu koreňa aorty od januára 2011 do decembra 2013. Sledovanie pacientov bolo uskutočnené echokardiografickou kontrolou v korelácii so odporúčaniami medzinárodného registra AVIATOR. Analýza prežívania pacientov zameraná na prežívanie bez reoperácie a nálezu aortálnej regurgitácie tretieho a vyššieho stupňa zaznamenala hemodynamickú stabilitu remodelácie koreňa aorty v horizonte 4 rokov na úrovni 89 % a v horizonte 6 rokov na úrovni 86 %. Univariačná regresná analýza neidentifikovala žiaden z porovnávaných vstupných a peroperačných parametrov ako faktor ovplyvňujúci stabilitu remodelácie a prežívanie. Remodelácia koreňa aorty a reimplantácia aortálnej chlopne dnes predstavujú pri vhodných anatomických pomeroch optimálnu terapeutickú stratégiu pre pacientov s aortálnou regurgitáciou a aneuryzmou koreňa aorty. Pri dodržaní požadovaných postupov prináša remodelácia koreňa aorty z hľadiska strednedobého, ale aj dlhodobého sledovania veľmi optimistické výsledky.
Aortic root remodeling was first published in the 1980s. Today's aortic root remodeling is geometrically precisely defined and indicated in every patient with aortic valve regurgitation in aortic root aneurysm. The aim of the work is to evaluate the medium-term results of aortic root remodeling in our conditions and the risk factors that have an impact on this stability. The work included 103 patients undergoing aortic root remodeling from January 2011 to December 2013. Patient follow-up was performed by echocardiographic control in correlation with the recommendations of the international AVIATOR registry. The analysis of patient survival focused on survival without reoperation and without the finding of aortic regurgitation of the third and higher degree recorded the hemodynamic stability of aortic root remodeling 4 years after surgery at the level of 89% and 6 years after the surgery at the level of 86%. Univariate regression analysis did not identify any of the compared factors and intraoperative parameters as factors affecting remodeling stability and survival. Remodeling of the aortic root and reimplantation of the aortic valve today represent an optimal therapeutic strategy for patients with aortic regurgitation and aortic root aneurysm in appropriate anatomical conditions. If the required procedures are followed, the remodeling of the aortic root brings very optimistic results from the point of view of medium-term as well as long-term follow-up.
Rostoucí seniorská křehkost stárnoucí populace vyžaduje stále méně invazivní výkony. I když se invazivita kardiochirurgických výkonů díky novým postupům a technickým prostředkům stále snižuje, je řada kandidátů operace na chlopních považována za nevhodné k výkonu z důvodu seniorské křehkosti, nestabilního oběhového systému, případně proto, že prodělali infarkt myokardu, a jejich život je tak ohrožen každý den, kdy nejsou operováni. Hlavním smyslem této experimentální modelové studie bylo ověřit nový způsob implantace umělých šlašinek mitrální chlopně apikální cestou s použitím nových nástrojů.
Increasing fragility with the aging population compels less invasive procedures. Even if cardiac surgeries are getting minimally invasive with new techniques and technological development in the field, many valve surgery candidates suffer from being qualified as inoperable due to fragility, unstable circulatory system, and to be post-myocardial infarction and their life is in danger every day that they are not operated. The main purpose of this case-based role model study is to invent a new technique for implanting a transapical mitral valve NeoChord implantation with new tools.
INTRODUCTION: The management of patients with severe aortic stenosis may differ according to patients' age. The aim of this analysis was to describe patterns of aortic valve replacement (AVR) use in European countries stratified by age. METHODS: Procedure volume data for AVR, including surgical aortic valve replacement (sAVR) and transcatheter aortic valve implantation (TAVI), for the years 2015-2020 were obtained from national databases for twelve European countries (Austria, the Czech Republic, Denmark, England, Finland, France, Germany, Norway, Poland, Spain, Sweden, and Switzerland). Procedure volumes were reported by patient age (<50 years, 5-year age groups between 50 and 85 years, and ≥85 years). Patients per million (PPM) population undergoing AVR each year were calculated using population estimates from Eurostat. RESULTS: AVR PPM varied widely between countries, from 508 PPM in Germany to 174 PPM in Poland in 2020. TAVI rates ranged from 61% in Switzerland and Finland to 25% in Poland. AVR PPM increased with age to a peak at 80-84 years, after which it decreased again. AVR procedures increased from 2015 to 2019 at an average annual rate of 3.9%. AVR increased more substantially in people aged ≥80 years than in younger age groups; these older age groups accounted for 30% of all AVR procedures in 2015 and 35% in 2019. TAVI accounted for an increasing proportion of all AVR procedures as patient age increased; an overall average of 96% of males and 98% of females aged ≥85 years received TAVI as the treatment modality, although adoption of TAVI differed between countries. CONCLUSIONS: There is considerable variation in the rates of AVR use and the adoption of TAVI versus sAVR between European countries. The use of TAVI has increased in recent years, particularly for older patients.
- MeSH
- aortální chlopeň chirurgie MeSH
- aortální stenóza * chirurgie MeSH
- chirurgická náhrada chlopně * metody MeSH
- lidé MeSH
- rizikové faktory MeSH
- senioři MeSH
- transkatetrální implantace aortální chlopně * metody MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Evropa MeSH
- MeSH
- aortální stenóza chirurgie terapie MeSH
- bioprotézy trendy MeSH
- chirurgická náhrada chlopně metody přístrojové vybavení veterinární MeSH
- diagnostické techniky kardiovaskulární trendy MeSH
- kongresy jako téma MeSH
- lidé středního věku MeSH
- lidé MeSH
- onemocnění aortální chlopně * chirurgie terapie MeSH
- randomizované kontrolované studie jako téma MeSH
- rizikové faktory MeSH
- senioři MeSH
- směrnice pro lékařskou praxi jako téma MeSH
- srdeční chlopně umělé klasifikace MeSH
- transkatetrální implantace aortální chlopně metody veterinární MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- Publikační typ
- novinové články MeSH
V článku jsou shrnuty nejpodstatnější změny týkající diagnosticky a léčby chlopenních vad srdce, které byly provedeny v doporučených postupech ESC (European Society of Cardiology) z roku 2021. S ohledem na výsledky publikovaných randomizovaných studií, nejvíce změn, co se týče třídy doporučení a síly evidence, je zaznamenáno ve výběru způsobu léčby aortální a mitrální chlopně a také managementu antitrombotické léčby.
The article summarize the most important changes regarding the management of valvular heart disease, which have been made in the ESC Guidelines 2021. Based on the randomized clinical study data, which were recently published, the most frequent changes were done in terms of the choice of mode of intervention in the aortic and mitral valves as well as in the management of the antithrombotic therapy.
- MeSH
- aortální stenóza chirurgie diagnóza MeSH
- chirurgická náhrada chlopně * metody MeSH
- inhibitory agregace trombocytů aplikace a dávkování terapeutické užití MeSH
- lidé MeSH
- mitrální insuficience chirurgie diagnóza MeSH
- nemoci srdečních chlopní chirurgie diagnostické zobrazování MeSH
- směrnice pro lékařskou praxi jako téma MeSH
- srdeční chlopně umělé škodlivé účinky MeSH
- trikuspidální insuficience chirurgie diagnóza MeSH
- Check Tag
- lidé MeSH
- MeSH
- arteria iliaca * abnormality chirurgie MeSH
- chirurgická náhrada chlopně metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
OBJECTIVES: The choice of optimal surgical treatment for young and middle-aged adults with aortic valve disease remains a challenge. Mechanical aortic valve replacement (mAVR) is generally preferred despite promising recent outcomes of the Ross procedure. Our goal was to compare the strategies at a nationwide level. METHODS: This study was a retrospective analysis of prospectively recorded data from the National Registry of Cardiac Surgery of the Czech Republic. Using propensity score matching, we compared the outcomes of patients undergoing the Ross procedure in 2 dedicated centres with all mAVRs performed in country between 2009 and 2020. RESULTS: Throughout the study period, 296 adults underwent the Ross procedure and 5120 had an mAVR. We found and compared 291 matched pairs. There were no in-hospital deaths, and the risk of perioperative complications was similar in both groups. Over the average follow-up period of 4.1 vs 6.1 years, the Ross group had a lower all-cause mortality (0.7 vs 6.5%; P = 0.015). This result remained significant even when accounting for cardiac- and valve-related deaths only (P = 0.048). Unlike the Ross group, the mAVR group had a significantly lower relative survival compared with the age- and sex-matched general population. There was no difference in the risk of reoperation (4.5 vs 5.5%; P = 0.66). CONCLUSIONS: The Ross procedure offers a significant midterm survival benefit over mAVR. The procedures have a comparable risk of perioperative complications. Patients after mAVR have reduced survival. Thus, the Ross procedure should be the preferred treatment option for young and middle-aged adults with aortic valve disease in dedicated centres.
- MeSH
- aortální chlopeň chirurgie MeSH
- chirurgická náhrada chlopně * metody MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- onemocnění aortální chlopně * MeSH
- reoperace MeSH
- retrospektivní studie MeSH
- srdeční chlopně umělé * MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH