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: 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
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
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
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.
- MeSH
- aortální chlopeň diagnostické zobrazování chirurgie MeSH
- aortální stenóza * diagnostické zobrazování chirurgie epidemiologie MeSH
- COVID-19 * epidemiologie MeSH
- lidé MeSH
- pandemie MeSH
- registrace MeSH
- rizikové faktory MeSH
- transkatetrální implantace aortální chlopně * škodlivé účinky metody MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
Aortální stenóza je nejčastější získanou chlopenní vadou v dospělosti a se stárnutím populace se prevalence tohoto onemocnění stále zvyšuje. Od roku 2002 se stala transkatétrová implantace aortální chlopně (TAVI) uznávanou alternativou k chirurgické náhradě aortální chlopně (SAVR). Zpočátku pro inoperabilní pacienty či pacienty s vysokým operačním rizikem, později i pro pacienty se středním a nízkým rizikem, což souvisí s technologickým rozvojem metody a zkušenostmi kardiocenter. Jakožto invazivní metoda má však i své komplikace, včetně protézové infekční endokarditidy (TAVI-IE) s incidencí 0,2-3,4 % a mortalitou až 67 % do dvou let od stanovení diagnózy. Z tohoto důvodu je zcela zásadní sanace aktivních infekčních fokusů v rámci předoperační přípravy. Naše kazuistika pacienta se symptomatickou významnou aortální stenózou a současně přítomnými infikovanými bércovými defekty jakožto zdroji bakteriemie s potenciálem rozvoje TAVI-IE ukazuje na nutnost multioborové spolupráce, individualizovaného rozhodnutí o léčebné strategii a dalšího pečlivého sledování nemocných po výkonu.
Aortic stenosis is the most common acquired valvular heart disease by adults and due to aging of population prevalence will increase. Since 2002 transcatheter aortic valve implantation (TAVI) has become a well-rec- ognized alternative for surgical aortic valve replacement (SAVR). Initially for inoperable patients or the high surgical risk patients, later even for the patients with medium and low risk. It all relates with technological progress of the method and increasing experience of cardiac centers. As invasive procedure, it has its own complications, including prosthetic infective endocarditis (TAVI-IE) with the incidence 0.3-3.4% and mortality up to 67% within 2 years after the diagnosis. That is why the preoperative screening and curing of active infectious focuses is absolutely necessary. Our case report of a patient with symptomatic severe aortic stenosis and infected venous leg ulcers, which are a source of bacteremia with potential development of TAVI-IE, shows the necessity of multidisciplinary cooperation as well as an individualized approach and further thorough patient's monitoring after TAVI.
- MeSH
- aortální stenóza patofyziologie patologie MeSH
- bakteriální endokarditida diagnóza etiologie MeSH
- bakteriální infekce diagnóza etiologie MeSH
- bércové vředy mikrobiologie MeSH
- kardiochirurgické výkony metody MeSH
- lidé MeSH
- senioři MeSH
- transkatetrální implantace aortální chlopně * metody MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- kazuistiky MeSH
Transkatétrová náhrada aortální chlopně (TAVI) se s nárůstem klinických zkušeností a technologickým vývojem stala vhodnou alternativou chirurgické náhrady chlopně (SAVR) u chirurgem neakceptovaných pacientů, ale i preferovanou metodou pro méně rizikové pacienty zejména ve vyšších věkových kategoriích. V porovnání se SAVR je však zatížena vyšším rizikem iatrogenních převodních poruch. Tyto poruchy vznikají převážně periprocedurálně či v časném pooperačním období a část z nich je plně reverzibilní. Naše kazuistika popisuje případ pacientky po TAVI, u které byla dokumentována nově vzniklá převodní porucha včetně proběhlých synkop. Cílem této kazuistiky je poukázat na schopnost reparace převodního systému po jeho mechanické iritaci související s provedeným TAVI. ©
Transcatheter aortic valve replacement (TAVI) has become a suitable alternative to surgical aortic valve replacement (SAVR) for patients not accepted by surgeons, but also a preferred method for lower-risk pa- tients, especially in older age groups. However, compared to SAVR, it is burdened with a higher risk of iatrogenic heart rhythm disturbances. These disturbances occur mostly periprocedurally or in the early postoperative period and some of them are fully reversible. Our case report describes the case of a patient after TAVI in whom a new-onset cardiac rhythm disturbance including ongoing syncope was documented. The aim of this case report is to highlight the ability of the conduction system to repair after its mechanical irritation related to the performed TAVI.
- MeSH
- atrioventrikulární blokáda diagnóza terapie MeSH
- blokáda Tawarova raménka diagnóza terapie MeSH
- elektrokardiografie metody MeSH
- kardiostimulátor MeSH
- lidé MeSH
- převodní systém srdeční patofyziologie patologie MeSH
- senioři nad 80 let MeSH
- transkatetrální implantace aortální chlopně * metody MeSH
- Check Tag
- lidé MeSH
- senioři nad 80 let MeSH
- ženské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
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
AIMS: Transcatheter aortic valve replacement (TAVR) has become the standard of care for selected patients with severe aortic stenosis. Multidetector computed tomography (MDCT) and transoesophageal 2D/3D (two-dimensional/three-dimensional) echocardiography (ECHO) are used for aortic annulus (AA) sizing. The aim of this study was to compare the accuracy of AA sizing by ECHO versus MDCT for Edwards Sapien balloon expandable valve in a single center. METHODS AND RESULTS: Data from 145 consecutive patients with TAVR (Sapien XT or Sapien S3) were analyzed retrospectively. A total of 139 (96%) patients had favorable outcomes after TAVR (at most mild aortic regurgitation and only one valve implanted). The 3D ECHO AA area and area-derived diameter were smaller than the corresponding MDCT parameters (464 ± 99 vs. 479 ± 88 mm2 , p < .001, and 24.2 ± 2.7 vs. 25.0 ± 5.5 mm, p = .002, respectively). The 2D ECHO annulus measurement was smaller than both the MDCT and 3D ECHO area-derived diameters (22.6 ± 2.9 vs. 25.0 ± 5.5 mm, p = .013, and 22.6 ± 2.9 vs. 24.2 ± 2.7 mm, p < .001, respectively) but larger than the minor axis diameter of the AA derived from MDCT and 3D ECHO by multiplanar reconstruction (p < .001). The 3D ECHO circumference-derived diameter was also smaller than the MDCT circumference-derived diameter (24.3 ± 2.5 vs. 25.0 ± 2.3, p = .007). The sphericity index by 3D ECHO was smaller than that by MDCT (1.2 ± .1 vs. 1.3 ± .1, p < .001). In up to 1/3 of the patients, 3D ECHO measurements would have predicted different (generally smaller) valve size than was the valve size implanted with favorable result. The concordance of the implanted valve size with the recommended size based on preprocedural MDCT and 3D ECHO AA area was 79.4% versus 61% (p = .001), and for the area-derived diameter, the concordance was 80.1% versus 61.7% (p = .001). 2D ECHO diameter concordance was similar to MDCT (78.7%). CONCLUSIONS: 3D ECHO AA measurements are smaller than MDCT measurements. If 3D ECHO-based parameters alone are used to size the Edwards Sapien balloon expandable valve, then the selected valve size would have been smaller than the valve size implanted with favorable result in 1/3 of the patients. MDCT preprocedural TAVR assessment should be the preferred method over 3D ECHO in routine clinical practice to determine Edwards Sapien valve size.
- MeSH
- aortální chlopeň diagnostické zobrazování chirurgie MeSH
- aortální stenóza * diagnostické zobrazování chirurgie etiologie MeSH
- echokardiografie transezofageální metody MeSH
- echokardiografie metody MeSH
- lidé MeSH
- multidetektorová počítačová tomografie metody MeSH
- protézy - design MeSH
- retrospektivní studie MeSH
- srdeční chlopně umělé * MeSH
- transkatetrální implantace aortální chlopně * metody MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH