RESUMO
Undeployed stent loss is a rare but potentially serious complication of percutaneous coronary intervention. Its management is not assisted by well-defined guidelines, and it is made even more difficult when the dislodged stent is not protected by in situ guidewire. In this work, we present the case of a total stent loss with a crushed device protruding out of the left main. In this hopeless circumstance, an innovative ping-pong technique was used to contralaterally perform a successful stent retrieval.
Assuntos
Angioplastia Coronária com Balão , Intervenção Coronária Percutânea , Humanos , Resultado do Tratamento , Stents , Intervenção Coronária Percutânea/efeitos adversos , Remoção de Dispositivo/métodosRESUMO
BACKGROUND: Evidence of clinical impact of PPM after TAVI is conflicting and might vary according to the type of valve implanted. AIMS: To assess the clinical impact of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) with balloon-expandable (BEV) and self-expandable valves (SEV) in patients with small annuli. METHODS: TAVI-SMALL 2 enrolled 628 patients in an international retrospective registry, which included patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 ) treated with transfemoral TAVI at 16 high-volume centers between 2011 and 2020. Analyses were performed comparing patients with less than moderate (n = 452), moderate (n = 138), and severe PPM (n = 38). Primary endpoint was incidence of all-cause mortality. Predictors of all-cause mortality and PPM were investigated. RESULTS: At a median follow-up of 380 days (interquartile range: 210-709 days), patients with severe PPM, but not moderate PPM, had an increased risk of all-cause mortality when compared with less than moderate PPM (log-rank p = 0.046). Severe PPM predicted all-cause mortality in patients with BEV (hazard ratio [HR]: 5.20, 95% confidence interval [CI]: 1.27-21.2) and intra-annular valves (IAVs, HR: 4.23, 95% CI: 1.28-14.02), and it did so with borderline significance in the overall population (HR: 2.89, 95% CI: 0.95-8.79). Supra-annular valve (SAV) implantation was the only predictor of severe PPM (odds ratio: 0.33, 95% CI: 0.13-0.83). CONCLUSIONS: Patients with small aortic annuli and severe PPM after TAVI have an increased risk of all-cause mortality at early term follow-up, especially after IAV or BEV implantation. TAVI with SAV protected from severe PPM.
Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/etiologia , Estudos Retrospectivos , Desenho de Prótese , Resultado do Tratamento , Substituição da Valva Aórtica Transcateter/efeitos adversosRESUMO
BACKGROUND: The relationship between high postprocedural mean gradient (ppMG) and clinical events following mitral valve transcatheter edge-to-edge repair (MV-TEER) in patients with degenerative mitral regurgitation (DMR) is still debated. AIM: The purpose of this study was to evaluate the effect of elevated ppMG after MV-TEER on clinical events in patients with DMR at 1-year follow-up. METHODS: The study included 371 patients with DMR treated with MV-TEER enrolled in the "Multi-center Italian Society of Interventional Cardiology (GISE) registry of trans-catheter treatment of mitral valve regurgitation" (GIOTTO) registry. Patients were stratified in tertiles according to ppMG. Primary endpoint was a composite of all-cause death and hospitalization due to heart failure at 1-year follow-up. RESULTS: Patients were stratified as follows: 187 with a ppMG ≤ 3 mmHg, 77 with a ppMG > 3/=4 mmHg, and 107 with a ppMG > 4 mmHg. Clinical follow-up was available in all subjects. At multivariate analysis, neither a ppMG > 4 mmHg nor a ppMG ≥ 5 mmHg were independently associated with the outcome. Notably, the risk of elevated residual MR (rMR > 2+) was significantly higher in patients belonging to the highest tertile of ppMG (p = 0.009). The association of ppMG > 4 mmHg and rMR ≥ 2+ was strongly and independently associated with adverse events (hazard ratio: 1.98; 95% confidence interval: [1.10-3.58]). CONCLUSIONS: In a real-world cohort of patients suffering DMR and treated with MV-TEER, isolated ppMG was not associated with the outcome at 1-year follow-up. A high proportion of patients showed both elevated ppMG and rMR and their combination appeared to be a strong predictor of adverse events.
Assuntos
Procedimentos Cirúrgicos Cardíacos , Insuficiência Cardíaca , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Resultado do Tratamento , Implante de Prótese de Valva Cardíaca/efeitos adversosRESUMO
BACKGROUND: Mitral-valve transcatheter edge-to-edge repair (MV-TEER) is recommended in patients with severe functional mitral regurgitation (FMR) and in those with degenerative mitral regurgitation (DMR) not eligible to traditional surgery. Patients with a history of previous cardiac surgery are considered at high risk for surgical reintervention, but data are lacking regarding procedural and clinical outcomes. OBJECTIVE: aim of this study was to assess the efficacy and clinical results of MV-TEER in patients with previous cardiac surgery enrolled in the "multicentre Italian Society of Interventional Cardiology registry of transcatheter treatment of mitral valve regurgitation" (GIOTTO). METHODS: Patients with previous coronary artery bypass grafting (CABG), surgical aortic valve replacement (AVR), or mitral valve repair (MVR) were included. Those with multiple or combined previous cardiac surgeries were excluded. Clinical follow-up was performed at 30 days, 1 year, and 2 years. The primary endpoint was a composite of death or rehospitalization at 1- and 2-year follow-ups. RESULTS: A total of 330 patients enrolled in the GIOTTO registry were considered (CABG 77.9%, AVR 14.2%, and MVR 7.9%). Most patients showed FMR (66.9%), moderate reduction of left ventricular (LV) ejection fraction, and signs of LV dilation. Procedural and device successes were 94.8% and 97%. At 1 and 2 years, the composite endpoint occurred are 29.1% and 52.4%, respectively. The composite outcome rates were similar across the three subgroups of previous cardiac surgery (p = 0.928) and between the FMR and DMR subgroups (p = 0.850) at 2 years. In a multivariate analysis, residual mitral regurgitation (rMR) ≥2+ was the main predictor of adverse events at 1 year (hazard ratio: 1.54 [95% confidence interval, CI: 1.00-2.38]; p = 0.050). This association was confirmed at 2 years of Kaplan-Meier analysis (p = 0.001). CONCLUSIONS: MV-TEER is effective in these patients, regardless of the subtype of previous cardiac surgery and the MR etiology. An rMR ≥2+ is independently associated with adverse outcomes at 1-year follow-up.
Assuntos
Procedimentos Cirúrgicos Cardíacos , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Cateterismo Cardíaco , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/cirurgia , Resultado do TratamentoRESUMO
Coronary bifurcation lesion (CBL) is a common but challenging scenario in percutaneous coronary interventions. Drug-coated balloons (DCBs) are modern devices with attractive perspective in CBL treatment. In-stent restenosis, small vessel and diffuse de-novo coronary artery disease have been, so far, considered the ideal scenario for DCBs application. Studies assessing DCBs in de-novo CBL demonstrated the safety and efficacy of this strategy. However, the heterogeneity of the study populations and the presence of methodological limitations prevent from drawing definite recommendations. Considering that the best treatment of bifurcations has not yet been defined, the "leaving nothing behind" philosophy will be the topic of future studies.
Assuntos
Angioplastia Coronária com Balão , Doença da Artéria Coronariana , Reestenose Coronária , Intervenção Coronária Percutânea , Angioplastia Coronária com Balão/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Resultado do TratamentoRESUMO
OBJECTIVES: Aim of this study is to evaluate safety, feasibility, and mid-term outcome of transcatheter aortic valve implantation (TAVI) in cardiogenic shock (CS). BACKGROUND: Balloon aortic valvuloplasty in patients with severe aortic valve stenosis (SAS) complicated by CS is indicated but associated with a grim prognosis. TAVI might be a more reasonable treatment option in this setting but data are scant. METHODS: From March 2008 to February 2019, 51 patients with severe aortic valvulopathy (native SAS or degenerated aortic bioprosthesis) and CS treated by TAVI in 11 European centers were included in this multicenter registry. Demographic, clinical, and procedural data were collected, as well as clinical and echocardiographic follow-up. RESULTS: The mean age of our study population was 75.8 ± 13, 49% were women, and mean Society of Thoracic Surgeons (STS) score was 19 ± 15%. Device success was achieved in 94.1%, with a 5% incidence of moderate/severe paravalvular leak. The 30-day events were mortality 11.8%, stroke 2.0%, vascular complications 5.9%, and acute kidney injury 34%. Valve Academic Research Consortium-2 early safety endpoint was reached in 35.3% of cases. At 1-year of follow-up, the mortality rate was 25.7% and the readmission for congestive heart failure was 8.6%. CONCLUSIONS: TAVI seems to be a therapeutic option for patients with CS and SAS or degenerated aortic bioprosthesis in terms of both safety and efficacy at early and long-term follow-up.
Assuntos
Estenose da Valva Aórtica/cirurgia , Choque Cardiogênico/etiologia , Substituição da Valva Aórtica Transcateter , Adulto , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Europa (Continente) , Estudos de Viabilidade , Feminino , Próteses Valvulares Cardíacas , Humanos , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente , Complicações Pós-Operatórias/mortalidade , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/mortalidade , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do TratamentoRESUMO
AIMS: We aim at exploring whether severe chronic kidney disease (CKD) may modify the impact of acute kidney injury (AKI) post-transcatheter aortic valve implantation (TAVI) on early, mid, and long-term mortality. METHODS AND RESULTS: The analysis included 2,733 TAVI patients from the Italian Clinical Service Project. The population was stratified in four groups according to the presence of baseline severe CKD and postprocedural AKI. All-cause mortality was the primary end point. Postprocedural AKI is associated with an increased risk of early and mid-term mortality after TAVI regardless of baseline severe CKD. Preprocedural severe CKD is associated with an increased risk of long-term mortality after TAVI regardless of postprocedural AKI. No interaction between preprocedural severe CKD and postprocedural AKI was observed in predicting mortality at both 30-day (CKD: hazard ratio [HR] = 2.65, 95% confidence interval [CI] = 1.15-6.12; no-CKD: HR = 3.83, 95% CI = 2.23-6.58; Pint = .129) and 1-year (CKD: HR = 2.29, 95% CI = 1.37-3.82; no-CKD: HR = 2.47, 95% CI = 1.75-3.49; Pint = .386). Preprocedural severe CKD is an independent predictor of postprocedural AKI (HR = 2.17, 95% CI = 1.56-3.03; p < .001) as well as general anesthesia and access alternative to femoral. Among no-AKI patients, those with severe CKD at admission underwent kidney function recovery after TAVI (serum creatinine at baseline 2.24 ± 1.57 mg/dL and at 48-hr 1.80 ± 1.17 mg/dL; p = .003). CONCLUSIONS: Preprocedural severe CKD did not modify the impact of postprocedural AKI in predicting early and mid-term mortality after TAVI. Closely monitoring of serum creatinine and strategies to prevent AKI post-TAVI are needed also in patients without severe CKD at admission.
Assuntos
Injúria Renal Aguda/mortalidade , Estenose da Valva Aórtica/cirurgia , Taxa de Filtração Glomerular , Rim/fisiopatologia , Insuficiência Renal Crônica/mortalidade , Substituição da Valva Aórtica Transcateter/mortalidade , Injúria Renal Aguda/diagnóstico , Injúria Renal Aguda/etiologia , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Biomarcadores/sangue , Causas de Morte , Creatinina/sangue , Feminino , Humanos , Itália/epidemiologia , Masculino , Estudos Prospectivos , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/fisiopatologia , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
Statin use is associated with enhanced pharmacodynamic response to clopidogrel in patients with stable coronary artery disease undergoing percutaneous coronary intervention (PCI). However, the impact of statin therapy on clopidogrel response profiles in patients with acute coronary syndrome (ACS) undergoing PCI has not been established and represents the objective of this investigation. On-treatment P2Y12 platelet reactivity was measured using the vasodilator stimulated phosphoprotein (VASP) phosphorylation assay before PCI, at hospital discharge, and at 1 month after PCI in ACS patients enrolled in the multicenter, prospective GEne polymorphisms, Platelet Reactivity, and Syntax Score (GEPRESS) study (n = 962). High platelet reactivity (HPR) was defined as platelet reactivity index ≥50%. Statins were prescribed at hospital discharge in 87% (n = 835) of patients. All patients were followed for 1 year. The 1-month HPR rate was lower in statin than in non-statin treated patients (39.6 vs 52%, respectively, p = 0.009). This finding was confirmed also among statin-treated patients with high Syntax score (≥15). After adjustment for differences in baseline characteristics, statin use at discharge was independently associated with 1-month HPR rate (odds ratio, 0.58, 95% confidence interval, 0.38-0.89; p = 0.015). In ACS patients undergoing PCI treated with clopidogrel the use of statins at discharge was associated with significantly lower 1-month HPR rates compared with patients not treated with statins.
Assuntos
Síndrome Coronariana Aguda/terapia , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Intervenção Coronária Percutânea , Ativação Plaquetária/efeitos dos fármacos , Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/cirurgia , Idoso , Idoso de 80 Anos ou mais , Clopidogrel , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/farmacologia , Pessoa de Meia-Idade , Ticlopidina/análogos & derivados , Ticlopidina/farmacocinéticaAssuntos
Infecções por Coronavirus/diagnóstico , Pneumonia Viral/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Idoso , Idoso de 80 Anos ou mais , Betacoronavirus/isolamento & purificação , COVID-19 , Angiografia Coronária , Infecções por Coronavirus/complicações , Infecções por Coronavirus/virologia , Ecocardiografia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/complicações , Pneumonia Viral/virologia , Fatores de Risco , SARS-CoV-2 , Infarto do Miocárdio com Supradesnível do Segmento ST/complicaçõesRESUMO
BACKGROUND: There is limited information on the long-term outcomes and prognostic clinical predictors after edge-to-edge transcatheter mitral valve repair with the MitraClip system. METHODS: Consecutive patients with mitral regurgitation (MR) undergoing MitraClip therapy between October 2008 and November 2013 in 4 Italian centers were analyzed. The primary end point of interest was all-cause death. The secondary end point was the composite of all-cause death or rehospitalization for heart failure. RESULTS: A total of 304 patients were included, of which 79% had functional MR and 17% were in New York Heart Association functional class IV. Acute procedural success was obtained in 92% of cases, with no intraprocedural death. The cumulative incidences of all-cause death were 3.4%, 10.8%, and 18.6% at 30 days, 1 year, and 2 years, respectively. The corresponding incidences of the secondary end point were 4.4%, 22.0%, and 39.7%, respectively. In the Cox multivariate model, New York Heart Association functional class IV at baseline and ischemic MR etiology were found to significantly and independently predict both the primary and the secondary end point. A baseline, left ventricular end-systolic volume >110 mL was found to be an independent predictor of the secondary endpoint. Acute procedural success was independently associated with a lower risk of all-cause death and the combination of all-cause death or rehospitalization for heart failure at long-term follow-up. CONCLUSIONS: In a cohort of patients undergoing MitraClip therapy, those presenting at baseline with ischemic functional etiology, severely dilated ventricles, or advanced heart failure and those undergoing unsuccessful procedures carried the worst prognosis.
Assuntos
Cateterismo Cardíaco/métodos , Anuloplastia da Valva Mitral/métodos , Insuficiência da Valva Mitral/cirurgia , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Insuficiência Cardíaca/fisiopatologia , Hospitalização/estatística & dados numéricos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/fisiopatologia , Mortalidade , Isquemia Miocárdica/complicações , Prognóstico , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Índice de Gravidade de Doença , Volume Sistólico , Resultado do TratamentoRESUMO
Introduction: Recent studies have shown gender differences in cardiovascular outcomes after left atrial appendage closure (LAAC), highlighting different complication rates and adverse events, particularly in short-term assessments. As a result, there remains a significant knowledge gap on how these differences directly impact the efficacy and safety of LAAC procedures. The aim of this retrospective study was to investigate the clinical outcomes of LAAC in women and men using the Watchman FLX device. Methods: This retrospective, multicenter study analyzes gender-specific outcomes in 650 patients who underwent LAAC with the Watchman FLX device between March 2019 and May 2022, drawn from the ITALIAN-FLX registry. Results: The results show comparable rates of all-cause mortality, stroke, transient ischemic attack and major bleeding in men and women 12 months after the procedure. Notably, no significant gender differences were found for periprocedural complications. Conclusion: In conclusion, this study shows that LAAC with the Watchman FLX device has comparable clinical outcomes between genders at both short-term and long-term follow-up.
RESUMO
Limited data are available about the impact of permanent pacemaker (PPM) implantation on long-term survival in patients with a bicuspid aortic valve (BAV) and severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR). We aimed to evaluate the long-term clinical outcomes of patients with BAV with AS who underwent periprocedural PPM implantation after TAVR with a self-expandable prosthesis. Data from patients with BAV and severe AS who underwent TAVR between April 2009 and January 2022 and followed in the framework of the One Hospital ClinicalService-CoreValve Project were collected. Patients were categorized in 2 groups according to PPM implantation after TAVR ("PPM" group) or not ("no PPM" group). The coprimary end points were all-cause death and a composite of cardiac mortality, rehospitalization because of cardiac causes, stroke, and myocardial infarction. Overall, 106 patients were considered (74 in the "no PPM" group and 32 in the "PPM" group). No statistically significant difference was found between the groups in terms of follow-up and baseline characteristics. Patients in the PPM group were more likely to show baseline conduction abnormalities (p = 0.023). Patients in the PPM group were more often treated with older generation prosthesis than those in the no PPM group (28.1% vs 5.4%, respectively, p = 0.013). At 2 years of follow-up, all-cause death in the no PPM and PPM groups occurred in 20.0% and 10.0% of patients, respectively (hazard ratio 0.37, 95% confidence interval 0.08 to 1.67). Similarly, no difference was evident for the composite end point between the 2 groups (no PPM vs PPM: 8 [14.6%] vs 6 [19.3%], hazard ratio 1.67, 95% CI 0.58 to 4.81). In conclusion, patients with severe AS and BAV treated with TAVR complicated by PPM implantation are not exposed to an increased risk of major adverse events at 2 years of follow-up.
Assuntos
Estenose da Valva Aórtica , Doença da Válvula Aórtica Bicúspide , Marca-Passo Artificial , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Doença da Válvula Aórtica Bicúspide/cirurgia , Resultado do Tratamento , Valva Aórtica/cirurgia , Fatores de RiscoRESUMO
BACKGROUND: Vascular complications (VCs) still represent one of the principal concerns of trans-femoral trans-catheter aortic valve replacement (TF-TAVR). New-generation devices can minimize such complications but the arterial access management is left to the operator's choice. This study aims to describe the rate of VCs in a contemporary cohort of patients undergoing TAVR with new-generation devices and to determine whether an ultrasound-guided (USG) vs. a fluoroscopy-guided (FG) femoral access management has an impact on their prevention. METHODS: This is a prospective, observational, multicenter study. Consecutive patients undergoing TAVR with new-generation devices were analyzed from January 2022 to October 2022 in five tertiary care centers. Femoral accesses were managed according to the operator's preferences. All the patients underwent a pre-discharge peripheral ultrasound control. VCs and bleedings were the main endpoints of interest. RESULTS: A total of 458 consecutive patients were enrolled (274 in the USG group and 184 in the FG group). VCs occurred in 6.5 % of the patients (5.2 % minor and 1.3 % major). There was no difference between the USG and the FG groups in terms of any VCs (7.3 % vs. 5.4 %; p = 0.4), or any VARC-3 bleedings (6.9 % vs 6 %, p = 0.9). At logistic regression analysis, the two guidance strategies did not result as predictors of VCs (odds Ratio 0.8, 95 % Confidence Interval 0.46-1.4; P = 0.4). CONCLUSIONS: In a contemporary cohort of patients undergoing TAVR with new-generation devices, the occurrence of VCs is low and mostly represented by minor VCs. USG and FG modalities did not affect the rate of VCs.
Assuntos
Valva Aórtica , Cateterismo Periférico , Artéria Femoral , Punções , Radiografia Intervencionista , Sistema de Registros , Substituição da Valva Aórtica Transcateter , Ultrassonografia de Intervenção , Humanos , Artéria Femoral/diagnóstico por imagem , Masculino , Feminino , Estudos Prospectivos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso de 80 Anos ou mais , Idoso , Fluoroscopia , Resultado do Tratamento , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/instrumentação , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Fatores de Risco , Radiografia Intervencionista/efeitos adversos , Próteses Valvulares Cardíacas , Fatores de Tempo , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Desenho de PróteseRESUMO
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.
Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/métodos , Estenose da Valva Aórtica/cirurgia , Resultado do Tratamento , Valva Aórtica/cirurgia , Sistema de Registros , Desenho de PróteseRESUMO
BACKGROUND: There is a lack of comparative data on transcatheter aortic valve implantation (TAVI) in degenerated surgical prostheses (valve-in-valve [ViV]). AIMS: We sought to compare outcomes of using two self-expanding transcatheter heart valve (THV) systems for ViV. METHODS: In this retrospective multicentre registry, we included consecutive patients undergoing transfemoral ViV using either the ACURATE neo/neo2 (ACURATE group) or the Evolut R/PRO/PRO+ (EVOLUT group). The primary outcome measure was technical success according to Valve Academic Research Consortium (VARC)-3. Secondary outcomes were 30-day all-cause mortality, device success (VARC-3), coronary obstruction (CO) requiring intervention, rates of severe prosthesis-patient mismatch (PPM), and aortic regurgitation (AR) ≥moderate. Comparisons were made after 1:1 propensity score matching. RESULTS: The study cohort comprised 835 patients from 20 centres (ACURATE n=251; EVOLUT n=584). In the matched cohort (n=468), technical success (ACURATE 92.7% vs EVOLUT 88.9%; p=0.20) and device success (69.7% vs 73.9%; p=0.36) as well as 30-day mortality (2.8% vs 1.6%; p=0.392) were similar between the two groups. The mean gradients and rates of severe PPM, AR ≥moderate, or CO did not differ between the groups. Technical and device success were higher for the ACURATE platform among patients with a true inner diameter (ID) >19 mm, whereas a true ID ≤19 mm was associated with higher device success - but not technical success - among Evolut recipients. CONCLUSIONS: ViV TAVI using either ACURATE or Evolut THVs showed similar procedural outcomes. However, a true ID >19 mm was associated with higher device success among ACURATE recipients, whereas in patients with a true ID ≤19 mm, device success was higher when using Evolut.
Assuntos
Insuficiência da Valva Aórtica , Bioprótese , Oclusão Coronária , Substituição da Valva Aórtica Transcateter , Humanos , Catéteres , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/cirurgia , Valvas Cardíacas , Sistema de Registros , Substituição da Valva Aórtica Transcateter/efeitos adversosRESUMO
BACKGROUND: The resorbable magnesium scaffold (RMS) is a second-generation bioresorbable scaffold (BRS) that has shown conflicting results in previous studies. These findings suggest that patient selection and implantation technique may have an impact on clinical outcomes. This study aimed to investigate the safety and long-term effectiveness of RMS in a narrowly selected population. METHODS: SHERPA-MAGIC is an investigator-driven, multicenter, prospective, single-arm study that enrolled patients undergoing BRS coronary implantation in 18 Italian centers. The present analysis considered the first 543 enrolled patients treated with RMS, with a minimum follow-up of 1 year. The study protocol included strict criteria for patient selection and standardization of RMS implantation. The primary outcome was the occurrence of the vessel-oriented composite endpoints (VOCE), including cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. RESULTS: Overall, 635 vessels were treated. The 1-year cumulative occurrence of VOCE was 22 (3.5%, 95% CI 2.2%-5.2%), which was significantly lower than the prespecified estimation (from 5.5% to 8.5%). At the median follow-up of 3.5 [2.6-4.3] years, there were 3 (0.5%) cardiac deaths, 12 (1.9%) target vessel myocardial infarctions, and 33 (5.2%) ischemia-driven target vessel revascularizations. A total of 37 (5.8%, 95%CI 4.1%-7.9%) VOCEs were detected. Scaffold thrombosis occurred in 4 (0.6%, 95%CI 0.1%-1.6%) cases. Patient-level analysis confirmed the findings of the vessel-level analysis. CONCLUSIONS: These results confirm the safety and performance of RMS technology. If confirmed in randomized controlled trials, they may rekindle interest in the use of scaffolds in daily practice.
Assuntos
Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Sirolimo , Magnésio , Estudos Prospectivos , Resultado do Tratamento , Implantes Absorvíveis , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio/etiologia , Desenho de PróteseRESUMO
BACKGROUND: Sex-specific characteristics in patients with aortic stenosis and small annuli undergoing transcatheter aortic valve implantation (TAVI) might affect clinical outcomes and hemodynamics. METHODS: TAVI-SMALL 2 international retrospective registry included 1378 patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area < 400 mm2) treated with transfemoral TAVI at 16 high-volume centers between 2011 and 2020. Women (n = 1233) were compared with men (n = 145). One-to-one propensity score (PS) matching resulted in 99 pairs. Primary endpoint was incidence of all-cause mortality. Incidence of pre-discharge severe prosthesis-patient mismatch (PPM) and its association with all-cause mortality were investigated. Binary logistic and Cox regression were performed to adjust the treatment effect for PS quintiles. RESULTS: Incidence of all-cause mortality at a median follow-up of 377 days did not differ between sex in the overall (10.3 vs. 9.8%, p = 0.842) and PS-matched (8.5 vs. 10.9%, p = 0.586) populations. After PS matching, pre-discharge severe PPM was numerically higher in women vs. men (10.2 vs. 4.3%), even though no evidence of a difference was found (p = 0.275). Within the overall population, women with severe PPM suffered a higher incidence of all-cause mortality when compared to those with less than moderate PPM (log-rank p = 0.024) and less than severe PPM (p = 0.027). CONCLUSIONS: No difference in all-cause mortality at medium-term follow-up was observed between women and men with aortic stenosis and small annuli undergoing TAVI. Incidence of pre-discharge severe PPM was numerically higher in women than men, and it was associated with increased all-cause mortality in women.
Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Masculino , Humanos , Feminino , Valva Aórtica/cirurgia , Estudos Retrospectivos , Pontuação de Propensão , Resultado do Tratamento , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Fatores de RiscoRESUMO
BACKGROUND: The ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR). AIMS: We sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices. METHODS: The NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification. RESULTS: A total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p>0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p<0.001). CONCLUSIONS: This retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.
Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Humanos , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Próteses Valvulares Cardíacas/efeitos adversos , Complicações Pós-Operatórias/etiologia , Desenho de Prótese , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
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.