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Transcatheter aortic valve replacement (TAVR) is a safe and effective treatment option for patients with severe aortic stenosis at intermediate or high surgical risk. Results after TAVR in low-risk patients are very encouraging at midterm follow-up, whereas limited long-term (≥3 year) data are available in this subset of patients. This meta-analysis aims to compare the long-term follow-up after TAVR versus surgical aortic valve replacement (SAVR) in low-risk patients. We searched databases up to July 7, 2024 for randomized clinical trials comparing TAVR versus SAVR in low-risk patients (defined as Society of Thoracic Surgeons Predicted Risk of Mortality score <4%) (PROSPERO ID: CRD42023480495). Primary outcome analyzed was all-cause death at a minimum of 3 years of follow-up. The secondary outcomes were cardiovascular death, disabling stroke, myocardial infarction, aortic valve reintervention, endocarditis, new-onset atrial fibrillation, permanent pacemaker implantation, and bioprosthetic valve failure. A total of 3 randomized clinical trials with 2,644 patients (TAVR nâ¯=â¯1,371 patients; SAVR nâ¯=â¯1,273 patients) were included. The follow-up time was 6 ± 2.9 years. TAVR resulted noninferior to SAVR for all-cause death (risk ratio [RR] 0.99, 95% confidence interval [CI] 0.84 to 1.17, pâ¯=â¯0.89, I2â¯=â¯28%), cardiovascular death (RR 0.94, 95% CI 0.76 to 1.15, pâ¯=â¯0.54, I2â¯=â¯0%), myocardial infarction (RR 1.06, 95% CI 0.71 to 1.57, pâ¯=â¯0.79, I2â¯=â¯61%), aortic valve reintervention, endocarditis, and bioprosthetic valve failure. New-onset atrial fibrillation was more common in the SAVR group, whereas permanent pacemaker implantation was more common in the TAVR group. In conclusion, our meta-analysis showed that TAVR is associated with similar long-term outcomes compared with SAVR in selected low-risk patients.
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INTRODUCTION: Over the past two decades, transcatheter aortic valve replacement (TAVR) has expanded its application across all surgical risk levels, including low-risk patients, where, due to longer life expectancy, reducing common pitfalls of TAVR is essential. To address these needs, many technological advancements have been developed. Myval and the new generation Myval Octacor (Meril Life Sciences Pvt. Ltd) are novel balloon-expandable (BE) transcatheter heart valve (THV) systems designed for the treatment of severe aortic stenosis. AREAS COVERED: This review aims to illustrate the design features of these novel THVs and the main evidence from available studies. Furthermore, we provide evidence of these THVs' performance in challenging scenarios such as extra-large aortic annuli, bicuspid aortic valves, and valve-in-valve/valve-in-ring procedures. EXPERT OPINION: Myval and Myval Octacor have demonstrated comparable early safety and clinical efficacy to the leading contemporary THVs, exhibiting remarkably low rates of moderate to severe paravalvular leak (PVL) and permanent pacemaker implantation (PPI). The wide range of sizes offered by the Myval family may minimize the risk of under-/oversizing, potentially explaining the lower rates of the aforementioned phenomena. Moreover, the presence of both internal skirt and external reinforced cuff may also explain the low rate of moderate to severe PVL.
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Estenosis de la Válvula Aórtica , Bioprótesis , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estenosis de la Válvula Aórtica/cirugía , Índice de Severidad de la Enfermedad , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagenRESUMEN
INTRODUCTION: Drug-coated balloon (DCB) is an established treatment option for in-stent restenosis and small vessel, de novo, coronary artery disease (CAD). Although the use of this tool is increasing in everyday practice, data regarding performance in the treatment of de novo, large vessel CAD (LV-CAD) is still lacking. A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of DCB versus drug-eluting stent (DES) in this setting. METHODS: A comprehensive literature search was performed including Medline, Embase, and Cochrane electronic databases up to January 24, 2024, for studies which compared the efficacy and safety of DCB versus DES in the treatment of de novo lesions in large vessels (≥ 2.5 mm), reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The analyzed outcomes were cardiovascular death (CVD), myocardial infarction (MI), target lesion revascularization (TLR), all-cause death (ACD), and late lumen loss (LLL) at follow-up. The effect size was estimated using a random effects model as risk ratio (RR) and mean difference (MD) and relative 95% confidence interval (CI). RESULTS: A total of 13 studies (6 randomized controlled trials and 7 observational studies) involving 2888 patients (DCB n = 1334; DES n = 1533) with de novo LV-CAD were included in this meta-analysis following our inclusion criteria. No differences were observed between DCB and DES in terms of CVD (RR 0.49; 95% CI [0.23-1.03]; p = 0.06), MI (RR 0.48; 95% CI [0.16-1.45]; p = 0.89), TLR (RR 0.73; 95% CI [0.40-1.34]; p = 0.32), ACD (RR 0.78; 95% CI [0.57-1.07]; p = 0.12), and LLL (MD - 0.14; 95% CI [- 0.30 to 0.02]; p = 0.10) at follow-up. DES proved a higher mean acute gain versus DCB [1.94 (1.73, 2.14) vs 1.31 (1.02, 1.60); p = 0.0006]. CONCLUSION: Our meta-analysis showed that DCB PCI might provide a promising option for the management of selected, de novo LV-CAD compared to DES. However, more focused RCTs are needed to further prove the benefits of a "metal-free" strategy in this subset of CAD.
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Introduction: Limited data exist on long-term follow-up of severe aortic stenosis (SAS) patients who have undergone transcatheter aortic valve implantation (TAVI) with a new generation, balloon expandable Myval transcatheter heart valve (THV). Thus, we sought to investigate the performance and 2-year clinical outcome of the Myval THV system based on Valve Academic Research Consortium-3 (VARC-3) criteria. Material and methods: A multi-centre, registry-based, observational study was conducted, which included 207 consecutive degenerative SAS patients, from Turkey (n = 128), Italy (n = 58), and Greece (n = 21) (mean [standard deviation] 81 (7) years, 94 [45%] men; 73% NYHA III or IV; EuroSCORE II 5.2% [2.4%]); all patients underwent TAVI with Myval. Patients were followed up at 1 year and 2 years after implantation. Clinical and procedural outcomes were defined according to VARC-3 criteria. Results: Technical success was observed in 204 (99%), device success was observed in 189 (91%), early safety was observed in 161 (78%), and clinical efficacy was observed in 163 (79%) patients. The 30-day death rate was 7.7%; of these, 3.4% were due to cardiovascular reasons. All-cause and cardiovascular mortality rates were 9.7% and 4.3% at 1-year follow-up, and 17.4% and 9.7% at 2-year follow-up, respectively. Incidence of ≥ moderate paravalvular leak (PVL) at 30 days, 1 year and 2 years of follow-up were 3.4%, 4.3% and 4.8%. A total of 11.1% of patients required a permanent pacemaker implantation (PPI) at 30 days after implantation, while the cumulative rate of PPI at 2 years was 12.1%. Conclusions: In this cohort of patients with SAS, the Myval was found to be safe and effective in up to 2 years of follow-up.
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BACKGROUND: The new balloon-expandable (BE) Myval transcatheter heart valves (THV) has shown promising early results with low paravalvular leak (PVL) and permanent pacemaker implantation (PPI) rates. Limited data are available regarding its long-term performance. We aimed to compare the 2-year clinical and echocardiographic outcomes of transcatheter aortic valve replacement (TAVR) using the self-expanding (SE) Evolut R and the BE Myval THVs. METHODS: The EVAL study included 166 patients with severe aortic valve stenosis who underwent TAVR either with SE Evolut R (n = 108) or BE Myval (n = 58) THV. Primary objectives include comparison on clinical efficacy (freedom from all-cause mortality, stroke, and cardiovascular hospitalization), echocardiographic performance and PPI rates between the two THVs. RESULTS: At 2-year the BE Myval group showed higher clinical efficacy (86% vs. 66%,HR:2.62, 95%CI 2.2-5.1;p = 0.006), with fewer cardiac hospitalizations (3.4% vs. 13.9%,p = 0.03). No significant differences in all-cause mortality, cardiovascular mortality, or stroke rates were observed. The proportion of patients with ≥moderate PVL was significantly lower in the BE Myval compared to the SE Evolut R group (4%vs. 22%,p = 0.008). The mean transvalvular gradient was significantly higher in the SE group compared to the BE group (9.5 ± 4.3 vs. 6.9 ± 2.2 mmHg,p < 0.001), however there was no difference in the percentage of patients with a mean gradient ≥20 mmHg between the two groups. CONCLUSIONS: Both THVs offer similar 2-year clinical outcomes. The BE Myval THV demonstrated advantages with higher clinical efficacy and lower PVL incidence. Longer follow-up and randomized trials are needed to validate these results and assess Myval's sustained performance and durability.
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Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Accidente Cerebrovascular , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Diseño de Prótesis , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Resultado del Tratamiento , Accidente Cerebrovascular/cirugíaRESUMEN
INTRODUCTION AND OBJECTIVES: After ST-segment myocardial infarction (STEMI), the impact of different adverse events on prognosis remains unknown. We aimed to assess very long-term predictors of patient-oriented composite endpoints (POCE) and investigate whether the occurrence of target vessel failure (TVF) vs a non-TVF event as the first event could potentially influence subsequent outcomes. METHODS: The EXAMINATION-EXTEND trial randomized STEMI patients to receive either an everolimus-eluting stent or a bare-metal stent. The follow-up period was 10 years. Predictors of POCE (a composite of all-cause death, any myocardial infarction, or any revascularization) were evaluated in the overall study population. The patients were stratified based on the type of first event (TVF-first vs non-TVF-first) and were compared in terms of subsequent POCE. TVF was defined as a composite of cardiac death, TV myocardial infarction, or TV revascularization. RESULTS: Out of the 1498 enrolled patients, 529 (35.3%) experienced a POCE during the 10-year follow-up. Independent predictors of POCE were age, diabetes mellitus, previous myocardial infarction, peripheral arterial disease, and multivessel coronary disease. The first event was a TVF in 296 patients and was a non-TVF in 233 patients. No significant differences were observed between TVF-first and non-TVF-first patients in terms of subsequent POCE (21.7% vs 39.3%, time ratio 1.79; 95%CI, 0.87-3.67;P=.12) or its individual components. CONCLUSIONS: At the 10-year follow-up, approximately one-third of STEMI patients had experienced at least 1 POCE. Independent predictors of these events were age, diabetes, and more extensive atherosclerotic disease. The occurrence of a TVF or a non-TVF as the first event did not seem to influence subsequent outcomes. TRIAL REGISTRATION NUMBER: NCT04462315.
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Diabetes Mellitus , Stents Liberadores de Fármacos , Infarto del Miocardio , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Humanos , Stents Liberadores de Fármacos/efectos adversos , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/epidemiología , Infarto del Miocardio/etiología , Intervención Coronaria Percutánea/efectos adversos , Pronóstico , Sirolimus , Infarto del Miocardio con Elevación del ST/diagnóstico , Infarto del Miocardio con Elevación del ST/cirugía , Infarto del Miocardio con Elevación del ST/complicaciones , Resultado del TratamientoRESUMEN
BACKGROUND: Transaxillary (TAx) transcatheter aortic valve implantation (TAVI) is a preferred alternative access in patients ineligible for transfemoral TAVI. AIMS: This study used the Trans-AXillary Intervention (TAXI) registry to compare procedural success according to different types of transcatheter heart valves (THV). METHODS: For the TAXI registry anonymized data of patients treated with TAx-TAVI were collected from 18 centers. Acute procedural, early and 1-month clinical outcomes were adjudicated in accordance with standardized VARC-3 definitions. RESULTS: From 432 patients, 368 patients (85.3%, SE group) received self-expanding (SE) THV and 64 patients (14.8%, BE group) received balloon-expandable (BE) THV. Imaging revealed lower axillary artery diameters in the SE group (max/min diameter in mm: 8.4/6.6 vs 9.4/6.8 mm; p < 0.001/p = 0.04) but a higher proportion of axillary tortuosity in BE group (62/368, 23.6% vs 26/64, 42.6%; p = 0.004) with steeper aorta-left ventricle (LV) inflow (55° vs 51°; p = 0.002) and left ventricular outflow tract (LVOT)-LV inflow angles (40.0° vs 24.5°; 0.002). TAx-TAVI was more often conducted by right sided axillary artery in the BE group (33/368, 9.0% vs 17/64, 26.6%; p < 0.001). Device success was higher in the SE group (317/368, 86.1% vs 44/64, 68.8%, p = 0.0015). In logistic regression analysis, BE THV were a risk factor for vascular complications and axillary stent implantation. CONCLUSIONS: Both, SE and BE THV can be safely used in TAx-TAVI. However, SE THV were more often used and were associated with a higher rate of device success. While SE THV were associated with lower rates of vascular complications, BE THV were more often used in cases with challenging anatomical circumstances.
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Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Válvula Aórtica/cirugía , Sistema de Registros , Diseño de PrótesisRESUMEN
BACKGROUND: De novo diffuse coronary artery disease (CAD) is a challenging scenario in interventional cardiology with limited treatment option, beside stent implantation. In this context, a hybrid approach, combining the use of drug-eluting stent (DES) and drug-coated balloon (DCB) to treat different segments of the same lesion (e.g. long lesion and/or true bifurcation), might be an interesting and alternative strategy to limit the metal amount. The aim of this study was to evaluate the safety and efficacy of a hybrid approach in addressing percutaneous treatment of de novo diffuse CAD. METHODS: This was a prospective, multicenter study including patients affected by de novo diffuse CAD treated with a hybrid approach from April 2019 to December 2020. Angiographic and clinical data were collected. The primary endpoint was the one-year device-oriented composite endpoint (DOCE, cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization [ID-TLR]). Periprocedural myocardial infarctions and periprocedural success were included among secondary endpoints. RESULTS: One hundred six patients were included, mean age was 68.2±10.2 years and 78.3% were male. De novo diffuse CAD consisted of 52.8% long lesions and 47.2% true bifurcation lesions. Significant increase in the final minimal lumen diameters and significant decrease in the final diameter stenosis were observed when compared to the baseline values in both DES- and DCB-target segments. Procedural success was 96.2%. DOCE at one-year was 3.7%, with all the adverse events characterized by ID-TLR. CONCLUSIONS: Combination of DES and DCB could be a safe and effective treatment option for the treatment of de novo diffuse CAD (NCT03939468).
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Angioplastia Coronaria con Balón , Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Infarto del Miocardio , Humanos , Masculino , Persona de Mediana Edad , Anciano , Femenino , Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos/efectos adversos , Estudios Prospectivos , Angioplastia Coronaria con Balón/efectos adversosRESUMEN
Symptomatic severe aortic stenosis (AS) in patients with intermediate-to-high surgical risk is currently being treated with transcatheter aortic valve replacement (TAVR). We present a case of a TAVR in a severe calcific AS with porcelain aorta and 'gothic' aortic arch. Pre-operative thoraco-abdominal computed tomography angiography showed also severe calcification at the sinotubular junction with protruding huge calcified nodules extending in ascending aorta and multiple calcific stenosis of both iliac-femoral vessels, severely tortuous. The choice of the interventional access was not easy and the high risk of an acute intra-procedural brain event guided the procedural planning. To our knowledge, this is the first case of TAVR with complete cerebral protection with Triguard system device and 'snaring-assisted' valve advancement.
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Transcatheter aortic valve replacement (TAVR) is a treatment of choice in patients with symptomatic severe aortic valve stenosis (AS) and intermediate-to-high surgical risk. The presence of a small aortic annulus (SAA) has been associated with a higher incidence of prosthesis-patient mismatch (PPM) when surgical aortic valve replacement (sAVR) is performed. TAVR might be a treatment option offering better hemodynamics with a lower incidence of PPM. When a severe AS with a SAA is treated, TAVR-related risk as the coronary obstruction and the annulus rupture, must be also prevented. We present a case of a TAVR in a very small aortic annulus; to our knowledge, this is the smallest native aortic annulus treated percutaneously in a tricuspid stenotic aortic valve with a Self-Expanding Transcatheter Heart Valve (THV) Acurate Neo 2.
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Percutaneous treatment of the left main coronary artery is one of the most challenging scenarios in interventional cardiology, due to the large portion of myocardium at risk the technical complexity of treating a complex bifurcation with large branches. Our aim is to provide un updated overview of the current indications for percutaneous treatment of the left main, the different techniques and the rationale underlying the choice for provisional versus upfront two-stent strategies, intravascular imaging and physiology guidance in the management of left main disease, and the role of mechanical support devices in complex high-risk PCI.
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BACKGROUND: Horizontal aorta (HA), defined by an aortic angulation (AA) ≥48°, is associated with worse outcomes particularly after self-expanding (SE) trans-catheter heart valve (THV) implantation. Although the SE ACURATE Neo THV demonstrated favorable procedural success rates in patients with HA, it remains associated with a non-negligible rate of moderate or greater paravalvular leak (PVL). OBJECTIVES: Aim of the study was to assess the performance of ACURATE Neo2 in the setting of HA. METHODS: We performed a multicenter cohort analysis on patients with severe aortic valve stenosis and HA undergoing transcatheter aortic valve replacement (TAVR) with the Neo or Neo2 THV enrolled in the ITAL-neo registry. The primary endpoint was a composite of early safety and clinical efficacy at 30 days according to the Valve Academic Research Consortium-3 (VARC-3). Secondary endpoints included the occurrence of moderate or severe PVL and 90-day clinical outcomes. RESULTS: Among 900 patients included in the ITAL-neo registry, 407 exhibited HA; of these, 300 received a Neo THV and 107 a Neo2 THV. HA, irrespective of the THV implanted, emerged as an independent risk factor for developing ≥ moderate PVL. Technical and device success at 30-day follow-up was comparable between groups. However, Neo2 was associated with a significantly lower rate of ≥moderate PVL vs. Neo: (5% vs. 15%; p < 0.001), which was confirmed also at 90-day follow-up. Additionally, no correlation was found between ≥moderate PVL and AA in the Neo2 group, while PVL degree increased proportionally to the AA in the Neo cohort. CONCLUSION: In patients with HA, the new generation Acurate Neo2 THV was associated with a comparable device success rate and a significantly lower rate of ≥moderate PVL, when compared with its predecessor.
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Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Diseño de Prótesis , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Sistema de RegistrosRESUMEN
Symptomatic aortic valve stenosis (AS) and abdominal aortic aneurysm (AAA) are critical clinical conditions, increasingly more prevalent with aging of the population. Calcific aortic stenosis is the most common structural cardiac disease in the elderly population, and medical management of severe aortic stenosis of the elderly population is associated with poor outcomes as compared to surgical treatment. Transcatheter aortic valve replacement (TAVR) is a treatment of choice in inoperable, often elderly, patients with symptomatic severe AS and in intermediate-to-high surgical risk patients. It is not yet clarified the incidence of AAA and its impact on procedural and clinical outcomes among patients undergoing TAVR. It is known that after AS resolution with aortic valve replacement or TAVR there is an increase in blood pressure that increases the risk of dissection or abdominal aortic aneurysm rupture if AAA repair is delayed. The purpose of this report is to describe the anatomical details and technical and procedural considerations when proposing totally endovascular strategies dedicated to the treatment of patients with AS and AAA.
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Aneurisma de la Aorta Abdominal , Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Humanos , Resultado del Tratamiento , Estenosis de la Válvula Aórtica/complicaciones , Válvula Aórtica/cirugía , Aneurisma de la Aorta Abdominal/complicaciones , Aneurisma de la Aorta Abdominal/cirugía , Factores de RiesgoRESUMEN
BACKGROUND: Little data exist on the relationship between total stent length (TSL) and cardiovascular outcomes at very-long follow-up in patients with ST-elevation myocardial infarction (STEMI) in the 2nd generation drug-eluting stents (DES) era. AIM: To analyze the relationship between TSL and 10-year target-lesion failure (TLF) in STEMI patients treated with percutaneous coronary intervention enrolled in the EXAMINATION-EXTEND. METHODS: The EXAMINATION-EXTEND was an extended-follow-up study of the EXAMINATION trial, which randomized 1:1 STEMI patients to receive DES or bare metal stent (BMS). The primary endpoint was TLF, defined as a composite of target lesion revascularization (TLR), target vessel myocardial infarction (TVMI), or definite/probable stent thrombosis (ST). Relationship between stent length and TLF was evaluated in the whole study group in a multiple-adjusted Cox regression model with TSL as a quantitative variable. Subgroup analysis was also performed according to stent type, diameter, and overlap. RESULTS: A total of 1,489 patients with a median TSL of 23 mm (Q1-Q318-35 mm) were included. TSL was associated with TLF at 10 years (adjusted HR per 5 mm increase of 1.07; 95% CI, 1.01-1.14; P = .02). This effect was mainly driven by TLR and was consistent regardless of stent type, diameter, or overlap. There was no significant relationship between TSL and TV-MI or ST. CONCLUSIONS: In STEMI patients, there is a direct relationship between TSL implanted in the culprit vessel and the risk of TLF at 10 years, mainly driven by TLR. The use of DES did not modify this association.
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Fármacos Cardiovasculares , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Humanos , Infarto del Miocardio con Elevación del ST/cirugía , Estudios de Seguimiento , Resultado del Tratamiento , Stents , Diseño de PrótesisRESUMEN
True coronary bifurcation lesions (CBL) represent a challenging scenario for percutaneous coronary interventions (PCI), and are associated with a higher risk of target lesion failure (TLF), particularly when two stents are implanted. A hybrid strategy combining a drug-eluting stent (DES) in the main branch, and a drug-coated balloon in the side branch may improve outcomes by reducing the total stent length while maintaining an effective anti-prolipherative action. In this sub-study of the HYPER trial, 50 patients with true CBL were treated with a hybrid strategy: procedural success was 96%, one case of peri-procedural myocardial infarction and one case of TLF (in a DES-treated segment) at 1 year were reported. This study suggests that such a hybrid strategy may be a safe and effective option for true CBL PCI, and warrants additional investigations to compare outcomes with standard of care strategies.
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Our understanding of the pathophysiology of acute coronary syndrome and of the vascular biology of coronary atherosclerosis has made enormous progress with the implementation of intravascular imaging. Intravascular imaging contributes to overcoming the known limitations of coronary angiography and allows for the in vivo discrimination of plaque morphology giving insight into the underlying pathology of the disease process. The possibility of using intracoronary imaging to characterize lesion morphologies and correlate them with clinical presentations may influence the treatment of patients and improve risk stratification, offering the opportunity for tailored management. This review examines the current role of intravascular imaging and describes how intracoronary imaging represents a valuable tool for modern interventional cardiology in order to improve diagnostic accuracy and offer a tailored approach to the treatment of patients with coronary artery disease, especially in the acute setting.
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Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Factores de RiesgoRESUMEN
BACKGROUND: TAVR is an established treatment for patients with severe symptomatic aortic stenosis. Different THV platforms are nowadays available, each of them with its inherent limitations and others are under development aiming at overcoming such limitations. We thus sought to investigate the performance and 1-year clinical outcome of a new generation, balloon expandable, THV: the Myval™ (Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India). METHODS: This registry included the first 100 consecutive patients (mean age 80.7 ± 7.7; STS 4.3 ± 3.3 %), who underwent transcatheter aortic valve implantation for severe stenosis of the native aortic valve from May 2020 to December 2020, in two Italian Centers. Clinical and procedural outcomes were defined according to VARC-3 criteria. RESULTS: Transfemoral Myval THV was successfully implanted in all patients, with no intra-hospital mortality (technical success 100 %): vascular access complications were all "minor" (16 %), and managed by compression/balloon inflation; no cases of annular rupture or coronary obstruction occurred; 5 % of patients required an in-hospital pacemaker implantation (PM). Device success was 99 %. Overall and cardiovascular mortality were 6 % (CI 5 %-7 %) and 4 % (CI 2 %-5 %) at 1- year, while 12 % (CI 9 %-14 %) and 7 % (6-9 %) at 2 years. A total of 9 % of the patients required a PM within 12 months, and no further PM implantation occurred afterwards. No cerebrovascular events, renal failure and myocardial infarction occurred between discharge and 2-year follow-up. No events of structural valve deterioration but a sustained improvement of echocardiographic parameters were observed. CONCLUSION: The Myval THV has a promising safety/efficacy profile at 2 year follow up. This performance should be further evaluated in the context of randomized trials to better elucidate its potential.