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OBJECTIVES: The objective was to evaluate the results of valve-in-valve procedures performed with the Allegra device. BACKGROUND: Transcatheter aortic valve implantation to treat degenerated biological aortic valves (valve-in-valve) is an established procedure in most catheterization laboratories, but the results are poorer than procedures done in native aortic stenosis. The Allegra device (Biosensors, Morges, Switzerland) has an excellent design to treat these patients. METHODS: All patients with severely degenerated biological aortic valve treated with the Allegra device in centers from Spain until December 2020 were included (n = 29). Hemodynamic results and 30-day clinical outcomes were evaluated. The predominant hemodynamic failure was stenosis in 15, regurgitation in 11, and a combination of both in 3 cases. Time from aortic valve replacement to valve-in-valve procedure was 8.4 ± 3.9 years (range 3.3-22.1). RESULTS: After the procedure, maximum and mean trans-valvular gradients were 17.4 ± 12.3 and 8.4 ± 6.1 mmHg, respectively. Device success was obtained in 28 patients (96.6%). In one patient with a degenerated 19 mm prosthetic valve, mean gradient after the procedure was 22 mmHg. No patients had a para-valvular leak grade >1. There were no deaths during the hospitalization or at 30 days and one patient suffered a stroke. CONCLUSIONS: The Allegra trans-catheter aortic valve offers optimal hemodynamic results in patients with severely degenerated biological aortic valve.
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Estenose da Valva Aórtica , Bioprótese , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Catéteres , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Desenho de Prótese , Sistema de Registros , Terfenadina/análogos & derivados , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
OBJECTIVES: We aimed to determine the safety and efficacy of the Allegra transcatheter heart valve (THV) for the treatment of severe aortic valve stenosis in a large patient population treated under real-world conditions. BACKGROUND: The Allegra is a novel self-expanding THV with supra-annular bovine leaflets. The valve is available in three different sizes (23, 27, and 31 mm), all are delivered through an 18F sheath. METHODS: Consecutive patients undergoing TAVR with the Allegra THV were enrolled in a multicenter-registry. Data were collected throughout initial hospital-stay and at 30-day follow-up. Clinical endpoints were defined according to the updated definitions of the Valve-Academic-Research-Consortium. RESULTS: This registry included 255 patients (mean age 83 ± 6 years, 48% women) from four European centers. Median European System for Cardiac Operative Risk Evaluation II score (EuroSCORE II) was 3.3% (IQR 1.9-5.8%). Acute device success was 95.7%. The remaining 11 patients had either moderate paravalvular regurgitation immediately after the procedure (7 patients) or the device could not be optimal positioned requiring implantation of a second THV (4 patients). Major vascular complications and major/life-threatening bleedings occurred in 10 (3.9%) and 12 (4.7%) patients, respectively. At 30 day follow-up, mean effective orifice area was 2.2 ± 0.5 cm2 , mean gradient was 6.9 ± 3.8 mmHg, 7 (3.3%) patients had more than mild paravalvular leakage, 3 patients (1.2%) had died, 6 patients (2.4%) had a stroke and 30 (12.8%) patients had required implantation of a new permanent pacemaker. CONCLUSIONS: Transfemoral implantation of the Allegra THV resulted in favorable clinical and echocardiographic outcomes during hospitalization and short-term follow up.
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Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Animais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Bovinos , Feminino , Humanos , Masculino , Desenho de Prótese , Sistema de Registros , Fatores de Risco , Terfenadina/análogos & derivados , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: Everolimus-eluting stent (EES) reduces the risk of restenosis in elective percutaneous coronary intervention. However, the use of drug-eluting stent in patients with ST-segment elevation myocardial infarction (STEMI) is still controversial. Data regarding the performance of second-generation EES in this setting are scarce. We report the 1-year result of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) trial, comparing EES with bare-metal stents (BMS) in patients with STEMI. METHODS: This multicentre, prospective, randomised, all-comer controlled trial was done in 12 medical centres in three countries. Between Dec 31, 2008, and May 15, 2010, we recruited patients with STEMI up to 48 h after the onset of symptoms requiring emergent percutaneous coronary intervention. Patients were randomly assigned (ratio 1:1) to receive EES or BMS. Randomisation was in blocks of four or six patients, stratified by centre and centralised by telephone. Patients were masked to treatment. The primary endpoint was the patient-oriented combined endpoint of all-cause death, any recurrent myocardial infarction, and any revascularisation at 1 year and was analysed by intention to treat. The secondary endpoints of the study included the device-oriented combined endpoint of cardiac death, target vessel myocardial infarction or target lesion revascularisation, and rates of all cause or cardiac death, recurrent myocardial infarction, target lesion or target vessel revascularisation, stent thrombosis, device and procedure success, and major and minor bleeding. This trial is registered with ClinicalTrials.gov, number NCT00828087. FINDINGS: Of the 1504 patients randomised, 1498 patients were randomly assigned to receive EES (n=751) or BMS (n=747). The primary endpoint was similar in both groups (89 [11·9%] of 751 patients in the EES group vs 106 [14·2%] of 747 patients in the BMS group; difference -2·34 [95% CI -5·75 to 1·07]; p=0·19). Device-oriented endpoint (44 [5·9%] in the EES group vs 63 [8·4%] in the BMS group; difference -2·57 [95% CI -5·18 to 0·03]; p=0·05) did not differ between groups, although rates of target lesion and vessel revascularisation were significantly lower in the EES group (16 [2·1%] vs 37 [5·0%], p=0·003, and 28 [3·7%] vs 51 [6·8%], p=0·0077, respectively). Rates of all cause (26 [3·5%] for EES vs 26 [3·5%] for BMS, p=1·00) or cardiac death (24 [3·2%] for EES vs 21 [2·8%] for BMS, p=0·76) or myocardial infarction (10 [1·3%] vs 15 [2·0%], p=0·32) did not differ between groups. Stent thrombosis rates were significantly lower in the EES group (4 [0·5%] patients with definite stent thrombosis in the EES group vs 14 [1·9%] in the BMS group and seven [0·9%] patients with definite or probable stent thrombosis in the EES group vs 19 [2·5%] in the BMS group, both p=0·019). Although device success rate was similar between groups, procedure success rate was significantly higher in the EES group (731 [97·5%] vs 705 [94·6%]; p=0·0050). Finally, Bleeding rates at 1 year were comparable between groups (29 [3·9%] patients in the EES group vs 39 [5·2%] in the BMS group; p=0·19). INTERPRETATION: The use of EES compared with BMS in the setting of STEMI did not lower the patient-oriented endpoint. However, at the stent level both rates of target lesion revascularisation and stent thrombosis were reduced in recipients of EES. FUNDING: Spanish Heart Foundation.
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Ligas de Cromo , Stents Farmacológicos , Imunossupressores/administração & dosagem , Infarto do Miocárdio/terapia , Sirolimo/análogos & derivados , Stents , Eletrocardiografia , Everolimo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/fisiopatologia , Método Simples-Cego , Sirolimo/administração & dosagemRESUMO
BACKGROUND: The SavvyWire (OpSens Inc) is a 0.035-inch preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring. OBJECTIVES: This study sought to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures. METHODS: This prospective, multicenter clinical study included patients with severe aortic stenosis undergoing TAVR in 8 European centers. The primary efficacy endpoint was defined as effective left ventricular rapid pacing runs with the guidewire translating into a significant systemic pressure drop (below 60 mm Hg). The safety outcome included the absence of major procedural complications related to the guidewire. RESULTS: A total of 121 patients (mean age: 82.2 ± 5.9 years, 50% women) were included in the study, and 119 (98.3%) patients were finally treated with the study device. A balloon-expandable valve was implanted in 45 (37.8%) patients. Predilatation and postdilatation were performed in 89 (74.8%) and 14 (11.8%) patients, respectively. The primary efficacy endpoint was achieved in 116 (98.3%) patients, and the mean aortic systolic arterial pressure achieved during rapid pacing was 46.6 ± 11.3 mm Hg. Hemodynamic assessment with the use of the OptoMonitor 3 (OpSens Inc) without additional catheter exchange was achieved in 117 (99.2%) patients. The safety endpoint was achieved in 117 (99.2%) patients. No procedural mortality, stroke, or ventricular perforation was reported. CONCLUSIONS: The use of the guidewire during TAVR procedures appeared to be efficacious and safe. This device could help minimize interventions during the procedure and improve the clinical decision making after transcatheter heart valve deployment. (SavvyWire Efficacy and Safety in Transcatheter Aortic Valve Implantation Procedures [SAFE-TAVI]; NCT05492383).
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Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Masculino , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estudos Prospectivos , Resultado do TratamentoRESUMO
Transcatheter aortic valve implantation (TAVI) is a procedure to treat severe aortic stenosis. There are several clinical concerns related to potential complications after the procedure, which demand the analysis of computerized tomography (CT) scans after TAVI to assess the implant's result. This work introduces a novel, fully automatic method for the analysis of post-TAVI 4D-CT scans to characterize the prosthesis and its relationship with the patient's anatomy. The method enables measurement extraction, including prosthesis volume, center of mass, cross-sectional area (CSA) along the prosthesis axis, and CSA difference between the aortic root and prosthesis, all the variables studied throughout the cardiac cycle. The method has been implemented and evaluated with a cohort of 13 patients with five different prosthesis models, successfully extracting all the measurements from each patient in an automatic way. For Allegra patients, the mean of the obtained inner volume values ranged from 10,798.20 mm3 to 18,172.35 mm3, and CSA in the maximum diameter plane varied from 396.35 mm2 to 485.34 mm2. The implantation of this new method could provide information of the important clinical value that would contribute to the improvement of TAVI, significantly reducing the time and effort invested by clinicians in the image interpretation process.
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INTRODUCTION AND OBJECTIVES: The PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept. The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system. METHODS: Procedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days. RESULTS: We included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P<.001). CONCLUSIONS: Transcatheter mitral valve repair with the PASCAL system was safe and effective, with high procedural success and low rates of MAE. At 30 days, MR was significantly reduced, with a significant improvement in functional status.
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Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Feminino , Idoso , Masculino , Insuficiência da Valva Mitral/diagnóstico , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Cateterismo Cardíaco/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: The timing and selection of optimal candidates for mitral transcatheter edge-to-edge valve repair remains to be fully determined, especially in cases with severely depressed left ventricular ejection fraction (LVEF). The objective of this study is to evaluate the prognostic value of myocardial strain (LVGLS) in this setting. METHODS: Retrospectively, 172 consecutive patients with LVEF ≤40% and severe MR treated with MitraClip were included. Four groups were generated according to the LVEF (<30% or ≥30%) and median LVGLS. The primary end-point was cardiovascular mortality. RESULTS: Procedural success was high (96.5%) and complications were rare. At one-year follow-up, 82.5% of patients maintained MR grade ≤2, 79.2% were at a NYHA class ≤II and a reduction of 80% in heart failure admissions was observed in all groups. Interestingly, among patients with a more depressed LVEF, LVGLS was found to be an independent predictor for cardiovascular mortality (HR: 3.3; 95% CI: 1.1-10, p = 0.023). CONCLUSIONS: Mitral valve repair with MitraClip is safe and it improves the mid-term functional class of patients regardless of LVEF. LVGLS can help in the selection of optimal candidates and timing for this procedure, as well as in the recognition of those patients with worse prognoses.
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BACKGROUND: Data regarding the safety and long-term effectiveness of percutaneous closure of paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) are scarce. AIMS: This study aims to present a large multicentre international experience of percutaneous post-TAVI PVL closure. METHODS: All patients who underwent percutaneous post-TAVI PVL closure in 14 hospitals across Europe and North America between January 2018 and October 2022 were included. RESULTS: Overall, 45 patients (64% male) were enrolled. The median age was 80 years (75-84). Among them, 67% and 33% had self-expanding and balloon-expandable valve implantations, respectively. Baseline post-TAVI PVL was severe in 67% of cases and moderate in the rest. The time from index TAVI to PVL closure procedure was 16.1 (8.7-34.8) months. Most patients were in NYHA Class III and IV (73%) before the procedure, and 40% had referred hospitalisations for heart failure between TAVI and the PVL closure procedure. Successful PVL closure was achieved in 94%, reducing regurgitation to ≤mild in 91% and moderate in the rest. The Amplatzer Valvular Plug III was the most frequently used device (27 cases), followed by the Amplatzer Valvular Plug 4. The incidence of severe adverse events was 11%. None of the patients died during the index hospitalisation. During long-term follow-up (21.7±16.2 months), the all-cause mortality rate was 14%, and patients presented improvement in functional status and a significant reduction in the rate of hospitalisation for heart failure (from 40% to 6%). CONCLUSIONS: Percutaneous PVL closure is a feasible and safe option for treating post-TAVI leaks. Successful PVL reduction to mild or less could be associated with acute and long-lasting improvements in clinical outcomes.
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Estenose da Valva Aórtica , Insuficiência Cardíaca , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Masculino , Idoso de 80 Anos ou mais , Feminino , Substituição da Valva Aórtica Transcateter/efeitos adversos , Próteses Valvulares Cardíacas/efeitos adversos , Resultado do Tratamento , Implante de Prótese de Valva Cardíaca/métodos , Sistema de Registros , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgiaRESUMO
BACKGROUND: Coronary obstruction (CO) following transcatheter aortic valve replacement (TAVR) is a life-threatening complication, scarcely studied. OBJECTIVES: The authors analyzed the incidence of CO after TAVR, presentation, management, and in-hospital and 1-year clinical outcomes in a large series of patients undergoing TAVR. METHODS: Patients from the Spanish TAVI (Transcatheter Aortic Valve Implantation) registry who presented with CO in the procedure, during hospitalization or at follow-up were included. Computed tomography (CT) risk factors were assessed. In-hospital, 30-day, and 1-year all-cause mortality rates were analyzed and compared with patients without CO using logistic regression models in the overall cohort and in a propensity score-matched cohort. RESULTS: Of 13,675 patients undergoing TAVR, 115 (0.80%) presented with a CO, mainly during the procedure (83.5%). The incidence of CO was stable throughout the study period (2009-2021), with a median annual rate of 0.8% (range 0.3%-1.3%). Preimplantation CT scans were available in 105 patients (91.3%). A combination of at least 2 CT-based risk factors was less frequent in native than in valve-in-valve patients (31.7% vs 78.3%; P < 0.01). Percutaneous coronary intervention was the treatment of choice in 100 patients (86.9%), with a technical success of 78.0%. In-hospital, 30-day, and 1-year mortality rates were higher in CO patients than in those without CO (37.4% vs 4.1%, 38.3% vs 4.3%, and 39.1% vs 9.1%, respectively; P < 0.001). CONCLUSIONS: In this large, nationwide TAVR registry, CO was a rare, but often fatal, complication that did not decrease over time. The lack of identifiable predisposing factors in a subset of patients and the frequently challenging treatment when established may partly explain these findings.
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Oclusão Coronária , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento , Catéteres , Sistema de RegistrosRESUMO
INTRODUCTION AND OBJECTIVES: This article presents the annual activity report of the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) for the year 2022. METHODS: All Spanish centers with catheterization laboratories were invited to participate. Data were collected online and were analyzed by an external company in collaboration with the members of the board of the ACI-SEC. RESULTS: A total of 111 centers participated. The number of diagnostic studies increased by 4.8% compared with 2021, while that of percutaneous coronary interventions (PCI) remained stable. PCIs on the left main coronary artery increased by 22%. The radial approach continued to be preferred for PCI (94.9%). There was an upsurge in the use of drug-eluting balloons, as well as in intracoronary imaging techniques, which were used in 14.7% of PCIs. The use of pressure wires also increased (6.3% vs 2021) as did plaque modification techniques. Primary PCI continued to grow and was the most frequent treatment (97%) in ST-segment elevation myocardial infarction. Most noncoronary procedures maintained their upward trend, particularly percutaneous aortic valve implantation, atrial appendage closure, mitral/tricuspid edge-to-edge therapy, renal denervation, and percutaneous treatment of pulmonary arterial disease. CONCLUSIONS: The Spanish cardiac catheterization and coronary intervention registry for 2022 reveals a rise in the complexity of coronary disease, along with a notable growth in procedures for valvular and nonvalvular structural heart disease.
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Cardiologia , Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Humanos , Cateterismo Cardíaco , Sistema de RegistrosRESUMO
Transcatheter aortic valve implantation (TAVI) has become the treatment of choice for patients with severe aortic stenosis and high surgical risk. Angiography has been established as an essential tool in TAVI, as this modality provides real-time images required to support the intervention. The automatic interpretation and parameter extraction on such images can lead to significative improvements and new applications in the procedure that, in most cases, rely on a prior identification of the transcatheter heart valve (THV). In this paper, U-Net architecture is proposed for the automatic segmentation of THV on angiographies, studying the role of its hyperparameters in the quality of the segmentations. Several experiments have been conducted, testing the methodology using multiple configurations and evaluating the results on different types of frames captured during the procedure. The evaluation has been performed in terms of conventional classification metrics, complemented with two new metrics, specifically defined for this problem. Those new metrics provide a more appropriate assessment of the quality of the results, given the class imbalance in the dataset. From an analysis of the evaluation results, it can be concluded that the method provides appropriate segmentation results for this dataset.
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INTRODUCTION AND OBJECTIVES: In patients with tricuspid regurgitation (TR), edge-to-edge transcatheter tricuspid valve repair (TTVR) is the strategy with the highest penetration worldwide. A dedicated edge-to-edge TTVR system has recently become available in Europe. The present study describes the initial experience with the system in Spain. METHODS: This multicenter study collected individual data from the centers accepted for the use of the novel system within an initial limited release. Between June 2020 and March 2021, all patients undergoing an edge-to-edge TTVR using the TriClip system in Spain were included in the study. The primary endpoint was the achievement of a TR reduction of at least 1 grade at discharge. RESULTS: We included 34 patients. Most of them reported a previous history of atrial fibrillation (91%) and only 1 had a pacemaker lead. The primary endpoint (TR reduction of at least 1 grade at discharge) was met in all patients. Most of the patients required 1 (47%) or 2 clips (44%) with a clear predominance of XT (87%) over NT (13%). The location of the first clip was anteroseptal in >90% of the patients. Only 1 patient had a partial detachment, which was stabilized with additional clips in the same procedure. At discharge, TR severity was≤2 in 91% of patients. At 3 months, mortality was nil. Overall, 88% of patients were in New York Heart Association functional class≤2 and 80% had residual TR≤2. CONCLUSIONS: Edge-to-edge TTVR seemed to be effective and safe with a sustained TR reduction at 3 months. Further studies will be needed to confirm our findings.
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Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Cateterismo Cardíaco/métodos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Valva Tricúspide/cirurgia , Insuficiência da Valva Tricúspide/cirurgiaRESUMO
INTRODUCTION AND OBJECTIVES: Transaxillary access (TXA) has become the most widely used alternative to transfemoral access (TFA) in patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to compare total in-hospital and 30-day mortality in patients included in the Spanish TAVI registry who were treated by TXA or TFA access. METHODS: We analyzed data from patients treated with TXA or TFA and who were included in the TAVI Spanish registry. In-hospital and 30-day events were defined according to the recommendations of the Valve Academic Research Consortium. The impact of the access route was evaluated by propensity score matching according to clinical and echocardiogram characteristics. RESULTS: A total of 6603 patients were included; 191 (2.9%) were treated via TXA and 6412 via TFA access. After adjustment (n=113 TXA group and n=3035 TFA group) device success was similar between the 2 groups (94%, TXA vs 95%, TFA; P=.95). However, compared with the TFA group, the TXA group showed a higher rate of acute myocardial infarction (OR, 5.3; 95%CI, 2.0-13.8); P=.001), renal complications (OR, 2.3; 95%CI, 1.3-4.1; P=.003), and pacemaker implantation (OR, 1.6; 95%CI, 1.01-2.6; P=.03). The TXA group also had higher in-hospital and 30-day mortality rates (OR, 2.2; 95%CI, 1.04-4.6; P=.039 and OR, 2.3; 95%CI, 1.2-4.5; P=.01, respectively). CONCLUSIONS: Compared with ATF, TXA is associated with higher total mortality, both in-hospital and at 30 days. Given these results, we believe that TXA should be considered only in those patients who are not suitable candidates for TFA.
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Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/etiologia , Estenose da Valva Aórtica/cirurgia , Humanos , Pontuação de Propensão , Sistema de Registros , Fatores de Risco , Substituição da Valva Aórtica Transcateter/métodos , Resultado do TratamentoRESUMO
INTRODUCTION AND OBJECTIVES: Transcatheter edge-to-edge repair (TEER) should be considered in patients with heart failure and secondary mitral regurgitation (MR). Angiotensin receptor-neprilysin inhibitors (ARNIs) have been demonstrated to improve prognosis in heart failure. We aimed to evaluate the impact ARNIs on patient selection and outcomes. METHODS: The population of the Spanish TEER prospective registry (March 2012 to January 2021) was divided into 2 groups: a) TEER before the ARNI era (n=450) and b) TEER after the recommendation of ARNIs by European Guidelines (n=639), with further analysis according to intake (n=52) or not (n=587) of ARNIs. RESULTS: A total of 1089 consecutive patients underwent TEER for secondary MR. In the ARNI era, there was a reduction in left ventricle dilation (82mL vs 100mL, P=.025), and better function (35% vs 38%, P=.011). At 2 years of follow-up, mortality (10.6% vs 17.3%, P <.001) and heart failure readmissions (16.6% vs 27.8%, P <.001) were lower in the ARNI era, but not recurrent MR. In the ARNI era, 1- and 2-year mortality were similar irrespective of ARNI intake but patients on ARNIs had a lower risk of readmission+mortality at 2 years (OR, 0.369; 95%CI, 0.137-0.992; P=.048), better NYHA class, and lower recurrence of MR III-IV (1.9% vs 14.3%, P=.011). CONCLUSIONS: Better patient selection for TEER has been achieved in the last few years with a parallel improvement in outcomes. The use of ARNIs was associated with a significant reduction in overall events, better NYHA class, and lower MR recurrence.
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Insuficiência Cardíaca , Insuficiência da Valva Mitral , Neprilisina , Humanos , Insuficiência Cardíaca/tratamento farmacológico , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/tratamento farmacológico , Insuficiência da Valva Mitral/cirurgia , Neprilisina/antagonistas & inibidores , Receptores de Angiotensina , Resultado do TratamentoRESUMO
AIMS: Patient access to reperfusion therapy and the use of primary percutaneous coronary intervention (p-PCI) or thrombolysis (TL) varies considerably between European countries. The aim of this study was to obtain a realistic contemporary picture of how patients with ST elevation myocardial infarction (STEMI) are treated in different European countries. METHODS AND RESULTS: The chairpersons of the national working groups/societies of interventional cardiology in European countries and selected experts known to be involved in the national registries joined the writing group upon invitation. Data were collected about the country and any existing national STEMI or PCI registries, about STEMI epidemiology, and treatment in each given country and about PCI and p-PCI centres and procedures in each country. Results from the national and/or regional registries in 30 countries were included in this analysis. The annual incidence of hospital admission for any acute myocardial infarction (AMI) varied between 90-312/100 thousand/year, the incidence of STEMI alone ranging from 44 to 142. Primary PCI was the dominant reperfusion strategy in 16 countries and TL in 8 countries. The use of a p-PCI strategy varied between 5 and 92% (of all STEMI patients) and the use of TL between 0 and 55%. Any reperfusion treatment (p-PCI or TL) was used in 37-93% of STEMI patients. Significantly less reperfusion therapy was used in those countries where TL was the dominant strategy. The number of p-PCI procedures per million per year varied among countries between 20 and 970. The mean population served by a single p-PCI centre varied between 0.3 and 7.4 million inhabitants. In those countries offering p-PCI services to the majority of their STEMI patients, this population varied between 0.3 and 1.1 million per centre. In-hospital mortality of all consecutive STEMI patients varied between 4.2 and 13.5%, for patients treated by TL between 3.5 and 14% and for patients treated by p-PCI between 2.7 and 8%. The time reported from symptom onset to the first medical contact (FMC) varied between 60 and 210 min, FMC-needle time for TL between 30 and 110 min, and FMC-balloon time for p-PCI between 60 and 177 min. CONCLUSION: Most North, West, and Central European countries used p-PCI for the majority of their STEMI patients. The lack of organized p-PCI networks was associated with fewer patients overall receiving some form of reperfusion therapy.
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Infarto do Miocárdio/terapia , Reperfusão Miocárdica/métodos , Angioplastia Coronária com Balão/estatística & dados numéricos , Europa (Continente)/epidemiologia , Acessibilidade aos Serviços de Saúde , Mortalidade Hospitalar , Hospitalização/estatística & dados numéricos , Humanos , Incidência , Infarto do Miocárdio/epidemiologia , Reperfusão Miocárdica/estatística & dados numéricos , Avaliação das Necessidades , Características de Residência , Fatores de TempoRESUMO
Trans-catheter aortic valve implantation (TAVI) is an increasingly adopted technique which provides a minimal invasive solution for patients who suffer from severe aortic stenosis. Some complications of the procedure could be annular rupture or paravalvular leakage, both related with adverse outcome. In TAVI with balloon expandable devices, a mismatch between those two factors leads to a conflict situation, where improving one worsens the other. The presented research proposes a methodology that uses numerical simulation to obtain certain TAVI outcomes related with aortic regurgitation due to paravalvular leakage, such as perivalvular area, aortic eccentricity or annular pressure. The application of the methodology for two patients shows the possibility of predicting those quantities. The highest stress values are distributed along the contact area. Results also show that a great deformation on the aortic annulus does not necessarily imply a higher stress; pressure can either be converted into root reshape or into root stretching. Validation of the results was done using scientific publications, clinical guidelines and clinical reports. Numerical simulation provides a suitable tool that could possibly contribute to optimize the planification procedure adjusting the mismatch between size and pressure.
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Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Humanos , Desenho de Prótese , Resultado do TratamentoRESUMO
INTRODUCTION AND OBJECTIVES: Aortic self-expandable (SE) transcatheter aortic valve implantation (TAVI) devices are particularly useful for patients with aortic stenosis and small/tortuous vessels, small aortic annuli, or low coronary ostia. However, it is unclear whether the growing range of SE devices shows comparable hemodynamic and clinical outcomes. We aimed to determine the differential hemodynamic (residual valve area and regurgitation) and clinical outcomes of these devices in comparable scenarios. METHODS: All patients were enrolled from 4 institutions and were managed with 4 different SE TAVI devices. Baseline and follow-up clinical data were collected and echocardiographic tests blindly and centrally analyzed. Patients were compared according to valve type and a 1:1 matched comparison was performed according to degree of calcification, aortic annulus dimensions, left ventricular ejection fraction, and body surface area. RESULTS: In total, 514 patients were included (Evolut R/PRO, 217; ACURATE neo, 107; ALLEGRA, 102; Portico, 88). Surgical risk scores were comparable in the unmatched population. No differences were observed in the post-TAVI regurgitation rate and in in-hospital mortality (2.7%). The rate of pacemaker implantation at discharge was significantly different among devices (P=.049), with Portico showing the highest rate (23%) and ACURATE neo the lowest (9.5%); Evolut R/PRO and ALLEGRA had rates of 15.9% and 21.2%, respectively. The adjusted comparison showed worse residual TAVI gradients and aortic valve area with ACURATE neo vs ALLEGRA (P=.001) but the latter had higher risk of valve embolization and a tendency for more cerebrovascular events. CONCLUSIONS: A matched comparison of 4 SE TAVI devices showed no differences regarding residual aortic regurgitation and in-hospital mortality.
Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Hemodinâmica , Humanos , Desenho de Prótese , Volume Sistólico , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
BACKGROUND AND AIM: Recent randomized data comparing percutaneous mitral valve repair (PMVR) versus optimal medical treatment in patients with functional MR (FMR) seemed to highlight the importance of the learning curve not only for procedural outcomes but also for patient selection. The aim of the study was to compare a contemporary series of patients undergoing PMVR using a second-generation Mitraclip device (Mitraclip NT) with previous cohorts treated with a first-generation system. METHODS: This multicenter study collected individual data from 18 centers between 2012 and 2017. The cohort was divided into three groups according to the use of the first-generation Mitraclip during the first (control-1) or second half (control-2) or the Mitraclip NT system. RESULTS: A total of 545 consecutive patients were included in the study. Among all, 182 (33.3%), 183 (33.3%), and 180 (33.3%) patients underwent mitral repair in the control-1, control-2, and NT cohorts, respectively. Procedural success was achieved in 93.3% of patients without differences between groups. Major adverse events did not statistically differ among groups, but there was a higher rate of pericardial effusion in the control-1 group (4.3%, 0.6%, and 2.6%, respectively; p = 0.025). The composite endpoint of death, surgery, and admission for congestive heart failure (CHF) at 12 months was lower in the NT group (23.5% in control-1, 22.5% in control-2, and 8.3% in the NT group; p = 0.032). CONCLUSIONS: The present paper shows that contemporary clinical outcomes of patients undergoing PMVR with the Mitraclip system have improved over time.
RESUMO
BACKGROUND: Isolated atrial fibrillation can cause mitral regurgitation (MR) in patients with normal left ventricular systolic function and no organic disease of the mitral valve. Little information is available regarding outcomes of Mitraclip in patients with atrial functional mitral regurgitation (AFMR). We aimed to evaluate 12-month clinical and echocardiographic outcomes of transcatheter mitral valve repair (TMVR) with MitraClip in patients with AFMR compared to those with ventricular functional or degenerative/mixed MR. METHODS: Registry-based analysis of all consecutive patients who underwent TMVR and were included in the Spanish Registry of Mitraclip. Changes in MR and NYHA functional class, and a combined endpoint including all-cause mortality and hospitalizations due to heart failure were the main outcomes. RESULTS: Overall, 1074 (69.1% male, 73.3 ± 10.2 years-old) patients were analyzed in this report. 48 patients (4.5%) presented AFMR. AFMR was significantly reduced after TMVR, with a procedural success rate of 91.7%, and this reduction persisted at 12-month (p < 0.001). Patients with AFMR showed a significant functional improvement at 6- and 12-month follow-up in our series (baseline: NYHA III 70.8% IV 18.8% vs. 1-year: NYHA III 21.7% IV 0%; p < 0.001). The probability of survival free of readmission for heart failure and all-cause mortality within the first year after TMVR was 74.9%. Procedural and clinical outcomes, as well as recurrent rates of MR were similar acutely and at 1-year compared to other etiologies. CONCLUSION: TMVR in patients with AFMR showed no significant differences compared to ventricular functional or degenerative/mixed MR regarding MR reduction or clinical outcomes.