RESUMO
Despite easy access to imaging diagnostic procedures and an abundance of spatial data, most cardiac interventions are still performed under two-dimensional fluoroscopy. Incorporating anatomical data from scans into procedures plans has the potential to improve the swiftness and outcomes of percutaneous cardiac interventions. Therefore, procedure planning based on the specific anatomy is becoming a new standard of excellence in interventional cardiology. Still, we often tend to disregard specific spatial relations and the actual direction of catheter tip movement inside the body, relying on a try and error approach. The precise spatial orientation of instruments and prosthetic devices is crucial, especially during structural heart interventions. Here, we present how deliberate movements of objects under fluoroscopy can reveal the spatial orientation of catheters and other devices. We also propose a novel "two-point rule" for identifying three-dimensional relations between points in space. Understanding and applying this rule might substantially increase the spatial awareness of operators performing cardiovascular interventions. Although the concept is pretty simple, using it "live" during interventional cardiology procedures requires thorough understanding and practice. We propose the "two-point rule" as a crucial rule to develop expertise in spatial orientation under fluoroscopy and ensure high-quality outcomes.
Assuntos
Catéteres , Intervenção Coronária Percutânea , Humanos , Desenho de Equipamento , Resultado do Tratamento , Fluoroscopia , Cateterismo CardíacoRESUMO
BACKGROUND: Transcatheter aortic valve implantation (TAVI) via total percutaneous transfemoral approach is an increasingly common technique for aortic stenosis treatment. It is primarily indicated in elderly with serious comorbidities. The epidemiology of these patients tends to overlap with the incidence of femoral hernia (FH). The appearance of hernia sac at the approach site and insufficient preoperational examination can lead to serious complications. We present the first-ever reported case of subsequent femoral hernia repair during transfemoral TAVI. CASE PRESENTATION: This report presents a case of FH/TAVI coincidence and literature review of its epidemiology. Literature review was performed to analyze similarities of femoral hernia and TAVI. The case describes an 84-year old female referred for elective TAVI. Intraoperation incarcerated femoral hernia was noticed and directly repaired. Further TAVI steps were performed on regular basis. A 2-year follow-up reported no local and general complications related to procedures. CONCLUSIONS: Unsuspected femoral hernia found subsequently with transfemoral TAVI may become a growing problem. The number of TAVI performed rises with indications expansion. Femoral hernia repairs constitute from 2 to 4% of all groin hernia. Both TAVI and FH are connected with elderly. Despite the fact of low FH incidence, growing number of TAVI performed and ageing of population, corresponds with higher possibility of complications. Most of these complications may end up fatal as they would involve high-risk patients. Insufficient attention is paid by cardiologists to the possible hernia appearance in the access site as this issue has been hardly ever presented in literature. Concomitant FH in TAVI patients should always be excluded in order to avoid serious complications. The case we report presents a successful subsequent FH repair during TAVI procedure. Further studies have to be conducted to provide data on how such problems ought to be managed.
Assuntos
Estenose da Valva Aórtica/cirurgia , Hérnia Femoral/cirurgia , Substituição da Valva Aórtica Transcateter/métodos , Idoso de 80 Anos ou mais , Feminino , Artéria Femoral , Humanos , Resultado do TratamentoRESUMO
BACKGROUND: Coronary artery disease (CAD) and degenerative aortic stenosis often coexist. However, the impact of CAD and its management on the prognosis after transcatheter aortic valve implantation (TAVI) remains uncertain. We sought to evaluate the impact of obstructive CAD, SYNTAX score (Ss), and percutaneous coronary intervention (PCI) prior to TAVI on short-term outcome. METHODS: Overall, 896 patients who underwent TAVI after heart team decision was included. Pre-procedural angiograms were analysed to calculate baseline Ss (bSs) and residual Ss (rSs). Baseline, procedural and follow-up data up to 30 days was acquired from the national POL-TAVI registry. RESULTS: Patients with obstructive CAD at baseline (n = 462, 52%) had higher mortality as compared with the remaining (8.7 vs. 5.1%, log-rank P = 0.039). Also, after correction for confounding factors obstructive CAD was identified as independent predictor of mortality (hazard ratio [HR] 1.74, 95% confidence intervals [CIs] 1.03-2.94, P = 0.037). In obstructive CAD, neither bSs (AUC 0.47, CI 0.38-0.56, P = 0.47) nor rSs (AUC 0.47, CI 0.30-0.64, P = 0.72 for those undergoing PCI and AUC 0.48, CI 0.37-0.59, P = 0.75 for the remaining) was predictive of mortality. When revascularization status was considered, patients with PCI prior to TAVI had similar outcome as those without obstructive CAD at baseline (7.7 vs. 5.1%, log-rank P = 0.23) with no negative impact on mortality (HR 1.13, CI 0.62-2.09, P = 0.69). CONCLUSIONS: In conclusion, obstructive CAD at baseline evaluation for TAVI has independent negative impact on short-term prognosis. However, neither baseline nor residual Ss values have prognostic ability in patients undergoing TAVI. Revascularization prior to TAVI seems to improve survival to levels comparable with patients without obstructive CAD at baseline.
Assuntos
Estenose da Valva Aórtica/cirurgia , Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Angiografia Coronária , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Feminino , Humanos , Masculino , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Polônia , Encaminhamento e Consulta , Sistema de Registros , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do TratamentoRESUMO
OBJECTIVE: To compare the safety and efficacy of transcathether aortic valve-in-valve implantation (ViV-TAVI) in degenerated stentless bioprostheses with failed stented valves and degenerated native aortic valves. INTRODUCTION: Little is known about ViV-TAVI in degenerated stentless valves. METHODS: Out of 45 ViV-TAVI procedures reported in the POL-TAVI registry, 20 failed stentless valves were compared with 25 stented prostheses and propensity-matched with 45 native TAVI cases. The mean follow-up was 633 (95% confidence interval [CI], 471-795) days and Valve Academic Research Consortium-2 (VARC-2) definitions were applied. RESULTS: Patients with degenerated stentless valves were younger (65.6, CI 58-73.1 years vs 75.6, CI 72.2-78 [stented] vs 80.1, CI 78.7-81.6 y. [native], P < 0.001). Implantation was required later after surgery (11.5, CI 8-14.9 years) in the stentless cohort as compared with the stented one (6.2, CI 4.7-7.6 years, P = 0.006). ViV-TAVI in the stentless group was also associated with larger amount of contrast (211, CI 157-266 mL vs 135, CI 104-167 mL [stented] vs 132 (119-145) mL [native], P = 0.022). Using VARC-2 composite endpoints, ViV-TAVI in stentless prostheses was characterized by a lower device success (50% vs 76% in stented vs 88.9% in native TAVI, P < 0.001), but comparable early safety up to 30 days (73.7% vs 84% vs 81.8%, respectively, log-rank P = 0.667) and long-term clinical efficacy beyond 30 days (72.2% vs 72% vs 73.8%, respectively, log-rank P = 0.963). CONCLUSIONS: Despite technical challenges and a lower device success, ViV-TAVI in stentless aortic bioprostheses achieves similar safety, efficacy, and functional improvement as in stented or degenerated native valves.
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Estenose da Valva Aórtica/cirurgia , Bioprótese/efeitos adversos , Próteses Valvulares Cardíacas/efeitos adversos , Falha de Prótese/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/cirurgia , Ecocardiografia , Feminino , Humanos , Masculino , Desenho de Prótese/efeitos adversos , Desenho de Prótese/métodos , Sistema de Registros , Stents , Análise de Sobrevida , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed approach that provides an alternative delivery route for valve replacement in patients with vascular abnormalities or existing comorbidities. While initial studies have shown the principal efficacy and safety, the real world effectiveness and safety of this approach remains to be fully assessed. METHODS/DESIGN: In this regard, the Registry Of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) represents the first multicenter, multinational prospective documentation of the course and outcome of patients with severe calcific aortic stenosis (AS) undergoing TAo-TAVI. ROUTE commenced in February 2013 with the goal of consecutively enrolling 300 patients at up to 22 sites across Europe. The primary objective of ROUTE is to determine the 30-day mortality associated with TAo-TAVI using the Edwards SAPIEN THV (Edwards Lifesciences, Irvine, CA). In addition, ROUTE aims to quantify complications, predictors of patient outcome and the value of CT guided valve sizing. DISCUSSION: Findings from this landmark registry will provide important information regarding procedural success rates and early mortality in patients undergoing TAo-TAVI. TRIAL REGISTRATION: Identifier: NCT01991431.
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Estenose da Valva Aórtica/terapia , Valva Aórtica/patologia , Calcinose/terapia , Cateterismo Cardíaco , Implante de Prótese de Valva Cardíaca/métodos , Sistema de Registros , Projetos de Pesquisa , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Calcinose/diagnóstico , Calcinose/mortalidade , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/mortalidade , Europa (Continente) , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Estudos Prospectivos , Desenho de Prótese , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
What is the efficacy and safety of transcatheter tricuspid valve-in-valve implantation for patients with inoperable tricuspid surgical prosthesis dysfunction? Thirty-day mortality after greatly effective transcatheter treatment is 2 times less than the estimated surgical risk.
Assuntos
Insuficiência Cardíaca , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Tricúspide , Humanos , Falha de Prótese , Valva Tricúspide/cirurgia , Resultado do Tratamento , Cateterismo Cardíaco , Desenho de Prótese , Insuficiência Cardíaca/cirurgiaRESUMO
BACKGROUND: The COVID-19 pandemic adversely affected health care systems. Patients in need of transcatheter aortic valve replacement (TAVR) are especially susceptible to treatment delays. OBJECTIVES: This study sought to evaluate the impact of the COVID-19 pandemic on global TAVR activity. METHODS: This international registry reported monthly TAVR case volume in participating institutions prior to and during the COVID-19 pandemic (January 2018 to December 2021). Hospital-level information on public vs private, urban vs rural, and TAVR volume was collected, as was country-level information on socioeconomic status, COVID-19 incidence, and governmental public health responses. RESULTS: We included 130 centers from 61 countries, including 65,980 TAVR procedures. The first and second pandemic waves were associated with a significant reduction of 15% (P < 0.001) and 7% (P < 0.001) in monthly TAVR case volume, respectively, compared with the prepandemic period. The third pandemic wave was not associated with reduced TAVR activity. A greater reduction in TAVR activity was observed in Africa (-52%; P = 0.001), Central-South America (-33%; P < 0.001), and Asia (-29%; P < 0.001). Private hospitals (P = 0.005), urban areas (P = 0.011), low-volume centers (P = 0.002), countries with lower development (P < 0.001) and economic status (P < 0.001), higher COVID-19 incidence (P < 0.001), and more stringent public health restrictions (P < 0.001) experienced a greater reduction in TAVR activity. CONCLUSIONS: TAVR procedural volume declined substantially during the first and second waves of the COVID-19 pandemic, especially in Africa, Central-South America, and Asia. National socioeconomic status, COVID-19 incidence, and public health responses were associated with treatment delays. This information should inform public health policy in case of future global health crises.
Assuntos
Estenose da Valva Aórtica , COVID-19 , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Pandemias , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/epidemiologia , Resultado do Tratamento , COVID-19/epidemiologia , Sistema de Registros , Fatores de RiscoRESUMO
BACKGROUND: The purpose of this study was to compare the safety and clinical outcomes of transcarotid (TC) and transapical access (TA) transcatheter aortic valve implantation (TAVI) patients whom the transfemoral approach (TF) was not feasible. METHODS: The analysis included consecutive patients with severe symptomatic aortic stenosis treated from 2017 to 2020 with TC-TAVI or TA-TAVI in two high-volume TAVI centers. The approach was selected by multidisciplinary heart teams after analyzing multislice computed tomography of the heart, aorta and peripheral arteries, transthoracic echocardiography and coronary angiography. RESULTS: One hundred and two patients were treated with alternative TAVI accesses (TC; n = 49 and TA; n = 53) in our centers. The groups were similar regarding age, gender, New York Heart Association class, and echocardiography parameters. Patients treated with TC-TAVI had significantly higher surgical risk. The procedural success rate was similar in both groups (TC-TAVI 98%; TA-TAVI 98.1%; p = 0.95). The rate of Valve Academic Research Consortium-2 defined clinical events was low in both groups. The percentage of new-onset rhythm disturbances and permanent pacemaker implantation was similar in TC and TA TAVI (4.1% vs. 11.3%; p = 0.17 and 10.2% vs. 5.7%; p = 0.39, respectively). In the TA-TAVI group, significantly more cases of pneumonia and blood transfusions were observed (11% vs. 0%; p = 0.01 and 30.2% vs. 12.2%; p = 0.03). The 30-day mortality was similar in TC and TA groups (4.1% vs. 5.7%; p = 0.71, respectively). CONCLUSIONS: Both TC and TA TAVI are safe procedures in appropriately selected patients and are associated with a low risk of complications.
Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/métodos , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Ecocardiografia , Contraindicações , Resultado do Tratamento , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodosRESUMO
BACKGROUND: The carotid artery is an alternative access route for transcatheter aortic valve implantation (TAVI), especially useful in patients unsuitable for traditional access routes including transfemoral (TF), subclavian, transapical, and aortic. AIMS: To investigate the feasibility and safety of transcarotid (TC) access for TAVI in comparison to the TF approach in a multicenter setting. METHODS: A total of 41 patients, treated between December 2014 and December 2018, were retrospectively reported to the Polish Registry of Common Carotid Artery Access for TAVI (POL-CAROTID). The median follow-up time was 619 (365-944) days, and Valve Academic Research Consortium-2 (VARC-2) definitions were applied. Clinical outcomes were compared with 41 propensity-matched TF-TAVI patients. RESULTS: The mean (standard deviation [SD]) patients' age was 78.0 (7.2) years, and 29 patients (70.7%) were men. Prohibitive iliofemoral anatomy and/or obesity (46.3%) and/or the presence of a stent graft in the abdominal aorta (31.7%) were the most common indications for TC-TAVI. Device success for TC-TAVI was comparable with the matched TF-TAVI group (90.2% vs. 95.3%, respectively, P = 0.396), and no periprocedural mortality was observed. Moreover, early safety was similar between the two groups (92.7% vs. 95.3%, respectively, log-rank P = 0.658) with only 1 case of non-disabling stroke during the first month after TC-TAVI. Consequently, no cerebrovascular events were observed in the mid-term, and the clinical efficacy of TC-TAVI corresponded well with TF-TAVI (90.2% vs. 92.7%, respectively, log-rank P = 0.716). A total of 4 (9.8%) deaths were noted in the TC-TAVI cohort in comparison to 3 (7.3%) in the TF-TAVI group. CONCLUSIONS: The results of the study indicated that the first cohort of Polish patients with implantations of second-generation transcarotid transcatheter heart valves had a similar prognosis to TF-TAVI with regard to safety and feasibility. TC access may be considered an optimal alternative for patients in whom the TF approach is precluded.
Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Masculino , Humanos , Idoso , Feminino , Substituição da Valva Aórtica Transcateter/efeitos adversos , Estenose da Valva Aórtica/cirurgia , Estudos Retrospectivos , Artérias Carótidas , Valva Aórtica/cirurgia , Resultado do Tratamento , Sistema de RegistrosRESUMO
Introduction: Data regarding patients with a previous medical record of immunosuppression treatment who have undergone transcatheter aortic valve implantation (TAVI) are limited and extremely inconclusive. Available studies are mostly short term observations; thus there is a lack of evidence on efficacy and safety of TAVI in this specific group of patients. Aim: To compare the in-hospital and long-term outcomes between patients with or without a medical history of immunosuppressive treatment undergoing TAVI for aortic valve stenosis (AS). Material and methods: We conducted a retrospective registry-based analysis including patients undergoing TAVI for AS at 5 centres between January 2009 and August 2017. The primary endpoint was long-term all-cause mortality. Secondary endpoints comprised major vascular complications, life-threatening or disabling bleeding, stroke and new pacemaker implantation. Results: Of 1451 consecutive patients who underwent TAVI, two propensity-matched groups including 25 patients with a history of immunosuppression and 75 patients without it were analysed. No differences between groups in all-cause mortality were found in a median follow-up time of 2.7 years following TAVI (p = 0.465; HR = 0.73; 95% CI: 0.30-1.77). The rate of major vascular complications (4.0% vs. 5.3%) was similar in the two groups (p = 1.000). There were no statistically significant differences in the composite endpoint combining life-threatening or disabling bleeding, major vascular complications, stroke and new pacemaker implantation (40.0% vs. 20.0%, p = 0.218). Conclusions: Patients who had undergone TAVI for AS had similar long-term mortality regardless of whether they had a previous medical record of immunosuppression. Procedural complication rates were comparable between the groups.
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BACKGROUND: Valve-in-valve transcatheter transfemoral mitral valve implantation (ViV-TMVI) is an emerging treatment alternative to reoperation in high surgical risk patients with a failed mitral bioprostheses. AIM: To describe characteristics and evaluate 30-day outcomes of ViV-TMVI in the Polish population. METHODS: Nationwide registry was initiated to collect data of all patients with failed mitral bioprosthesis undergoing ViV-TMVI in Poland. This study presents 30-days clinical and echocardiographic follow-up. RESULTS: Overall, 27 ViV-TMVI were performed in 8 centers until May 2022 (85% since 2020). Mean (standard deviation [SD]) age was 73 (11.6) years with the median (interquartile range [IQR]) STS score of 5.3% (4.3%-14.3%). Mean (SD) time between surgical implantation and ViV-TMVI was 8.2 (3.2) years. Failed Hancock II (29%) and Perimount Magna (22%) were most frequently treated. Mechanisms of failure were equally often pure mitral regurgitation or stenosis (both 37%) with mixed etiology in 26%. Balloon-expandable Sapien 3/Ultra were used in all but 1 patient. Technical success was 96.3% (1 patient required additional prosthesis). Mean (SD) transvalvular mitral gradient reached 6.7 (2.2) mm Hg and mitral valve area was 1.8 (0.4) cm². None of the patients had moderate or severe mitral regurgitation with only 14.8% graded as mild. In 92.6% device success (2 patients had mean gradient ≥10 mm Hg) and in 85.6% procedural success was present. There were no deaths, cerebrovascular events or need for mitral valve surgery during 30-day follow-up. CONCLUSIONS: In short-term observation ViV-TMVI is safe and effective alternative for patients with failed mitral bioprosthesis at high surgical risk of re-operation. Longer observations on larger sample are warranted.
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BACKGROUND: Regional citrate anticoagulation (RCA) is the recommended standard for continuous renal replacement therapy (CRRT). This study assesses its efficacy in patients admitted to critical care following cardiovascular surgery and the influence of standard antithrombotic agents routinely used in this specific group. METHODS: Consecutive cardiovascular surgery patients treated with postdilution hemofiltration with RCA were included in this prospective observational study. The primary outcome of the study was CRRT circuit life-span adjusted for reasons other than clotting. The secondary outcome evaluated the influence of standard antithrombotic agents (acetylsalicylic acid [ASA], low molecular weight heparin [LMWH] or fondaparinux as thromboprophylaxis or treatment dose with or without ASA) on filter life. RESULTS: Fifty-two patients underwent 193 sessions of continous veno-venous hemofiltration, after exclusion of 15 sessions where unfractionated heparin was administered. The median filter life span was 58 hours. Filter life span was significantly longer in patients receiving therapeutic dose of LMWH or fondaparinux (79 h [2-110]), in comparison to patients treated with prophylactic dose of LMWH or fondaparinux (51 h [7-117], p < 0.001), and patients without antithrombotic prophylaxis (42 h [2-91], p < 0.0001). 12 bleeding episodes were observed; 8 occurred in patients receiving treatment dose anticoagulation, 3 in patients receiving prophylactic dose anticoagulation and 1 in a patient with no antithrombotic prophylaxis. CONCLUSIONS: A postdilution hemofiltration with RCA provides prolonged filter life span when adjusted for reasons other than clotting. Patients receiving treatment dose anticoagulation had a significantly longer filter life span than those who were on prophylactic doses or ASA alone.
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Terapia de Substituição Renal Contínua , Hemofiltração , Tromboembolia Venosa , Anticoagulantes/efeitos adversos , Ácido Cítrico/efeitos adversos , Terapia de Substituição Renal Contínua/efeitos adversos , Fibrinolíticos/uso terapêutico , Fondaparinux , Hemofiltração/efeitos adversos , Heparina/efeitos adversos , Heparina de Baixo Peso Molecular/efeitos adversos , Humanos , Longevidade , Tromboembolia Venosa/induzido quimicamente , Tromboembolia Venosa/tratamento farmacológicoRESUMO
BACKGROUND: Atrial fibrillation (AF) is a relatively common comorbidity among patients referred for coronary artery bypass grafting (CABG) and is associated with poorer prognosis. However, little is known about how surgical technique influences survival in this population. AIM: The current analysis aimed to determine whether total arterial revascularization (TAR) is associated with improved long-term outcomes in patients with preoperative AF. METHODS: We analyzed patients' data from the HEIST (HEart surgery In atrial fibrillation and Supraventricular Tachycardia) registry. The registry, to date, involves five tertiary high-volume centers in Poland. Between 2006 and 2019, 4746 patients presented with preoperative AF and multivessel coronary artery disease and underwent CABG. We identified cases of TAR and used propensity score matching to determine non-TAR controls. Median follow-up was 4.1 years (interquartile range [IQR], 1.9-6.8 years). RESULTS: Propensity matching resulted in 295 pairs of TAR vs. non-TAR. The mean (standard deviation [SD]) number of distal anastomoses was 2.5 (0.6) vs. 2.5 (0.6) (P = 0.94) respectively. Operative and 30-day mortality was not different between TAR and non-TAR patients (hazard ratio [HR] and 95% confidence intervals [CIs], 0.17 (0.02-1.38); P = 0.12 and 0.74 [0.40-1.35]; P = 0.33, respectively). By contrast, TAR was associated with nearly 30% improved late survival: HR, 0.72 (0.55-0.93); P = 0.01. This benefit was sustained in subgroup analyses, yet most pronounced in low-risk patients ( < 70 years old; EuroSCORE II < 2; no diabetes) and when off-pump CABG was performed. CONCLUSIONS: TAR in patients with preoperative AF is safe and associated with improved survival, with particular survival benefits in younger low-risk patients undergoing off-pump CABG.
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Fibrilação Atrial , Ponte de Artéria Coronária sem Circulação Extracorpórea , Doença da Artéria Coronariana , Humanos , Idoso , Fibrilação Atrial/complicações , Estudos Retrospectivos , Ponte de Artéria Coronária , Ponte de Artéria Coronária sem Circulação Extracorpórea/efeitos adversos , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/cirurgia , Resultado do TratamentoRESUMO
Objectives: Patients with bicuspid aortic valve (BAV) stenosis were excluded from the pivotal trials of transcatheter aortic valve implantation (TAVI). We compared the in-hospital and long-term outcomes between patients undergoing TAVI for bicuspid and tricuspid aortic valve (TAV) stenosis. Methods: We performed a retrospective registry-based analysis on patients who underwent TAVI for BAV and TAV at five different centers between January 2009 and August 2017. The primary outcome was long-term all-cause mortality. Secondary outcomes were in-hospital mortality, procedural complications, and valve performance. Results: Of 1,451 consecutive patients who underwent TAVI, two propensity-matched cohorts consisting of 130 patients with BAV and 390 patients with TAV were analyzed. All-cause mortality was comparable in both groups up to 10 years following TAVI (HR 1.09, 95% CI: 0.77-1.51). Device success and in-hospital mortality were comparable between the groups (96 vs. 95%, p = 0.554 and 2.3 vs. 2.1%, p = 0.863, respectively). Incidence of procedural complications was similar in both groups, with a trend toward a higher rate of stroke in patients with BAV (5 vs. 2%, p = 0.078). Incidence of moderate or severe paravalvular leak (PVL) at discharge was comparable in both groups (2 vs. 2%, p = 0.846). Among patients with BAV, all-cause mortality was similar in self-expanding and balloon-expandable prostheses (HR 1.02, 95% CI: 0.52-1.99) and lower in new-generation devices compared to old-generation valves (HR 0.27, 95% CI 0.12-0.62). Conclusion: Patients who had undergone TAVI for BAV had comparable mortality to patients with TAV up to 10 years after the procedure. The device success, in-hospital mortality, procedural complications, and PVL rate were comparable between the groups. The high rate of neurological complications (5%) in patients with BAV warrants further investigation.
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BACKGROUND: Stroke remains a feared complication associated with transcatheter aortic valve implantation (TAVI). Embolic cerebral injury occurs in the majority of TAVI cases and can lead to cognitive dysfunction. AIMS: The PROTEMBO C Trial evaluated the safety and performance of the ProtEmbo Cerebral Protection System in TAVI patients. METHODS: Forty-one patients were enrolled in this single-arm study conducted at 8 European centres. The primary safety endpoint was the rate of VARC 2-defined major adverse cardiac and cerebrovascular events (MACCE) at 30 days; the primary performance endpoint was the composite rate of technical success versus performance goals (PG). Secondary endpoints included brain diffusion-weighted magnetic resonance imaging (DW-MRI), new lesion volume, and the rate of death or all strokes compared to historical data. RESULTS: Thirty-seven of 41 enrolled patients underwent TAVI with the ProtEmbo device (intention-to-treat [ITT] population). Both primary endpoints were met. MACCE at 30 days was 8.1% (upper limit of the 95% confidence interval [CI]: 21.3% vs PG 25%; p=0.009), and technical success was 94.6% (lower limit of the 95% CI: 82.3% vs PG 75%; p=0.003). New DW-MRI lesion volumes with ProtEmbo were smaller than in historical data, and 87% of patients completing MRI follow-up had no single lesion >150 mm3. There was 1 stroke in a patient in whom the device was removed prematurely before TAVI completion. CONCLUSIONS: The PROTEMBO C Trial met its primary safety and performance endpoints compared to prespecified historical PGs. Patients had smaller brain lesion volumes on DW-MRI compared to prior series and no larger single lesions. These results warrant further evaluation of the ProtEmbo in a larger randomised controlled trial (RCT).
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Dispositivos de Proteção Embólica , Substituição da Valva Aórtica Transcateter , Imagem de Difusão por Ressonância Magnética , Dispositivos de Proteção Embólica/efeitos adversos , Humanos , Embolia Intracraniana/etiologia , Embolia Intracraniana/prevenção & controle , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Resultado do TratamentoRESUMO
INTRODUCTION: Transcatheter aortic valvein valve implantation (ViVTAVI) has emerged as an alternative to redo surgery in patients with failed surgical aortic bioprosthesis. OBJECTIVES: We evaluated the safety and efficacy of ViVTAVI in Polish patients after surgical aortic valve replacement. PATIENTS AND METHODS: This was a nationwide multicenter registry of ViVTAVI procedures. Data were collected using an online form, and the clinical follow up lasted 1 year. RESULTS: From 2008 to 2020, 130 ViVTAVI procedures were performed (1.9% of all transcatheter aortic valve implantation [TAVI] cases). A considerable increase in ViVTAVI procedures since 2018 has been observed (n = 59, 45% of ViVTAVI cases). Hancock II, Freestyle, and homograft were the most frequently treated bioprostheses. The self expanding supra annular Corevalve / Evolut valve was used in 76% of cases. In 21% of cases, the mean postprocedural pressure gradient (PG) exceeded 20 mm Hg. Allcause mortality at 1 year was 10.8%. Aortic valve stenosis was associated with a higher mean PG than aortic valve regurgitation or mixed disease (P = 0.004). Supra annular transcatheter aortic valves were associated with lower mean PGs than intra annular valves (P = 0.004). Second generation devices were associated with shorter procedure time (120 min vs 135 min, P = 0.04), less frequent need for additional TAVI (2% vs 10%, P = 0.04), and lower 1year cardiovascular mortality (95% vs 82.8%, P = 0.03) than firstgeneration valves. CONCLUSIONS: Transcatheter treatment of failed bioprostheses is increasingly common, with the best hemodynamic effect shown for supra annular valves. The introduction of secondgeneration valves has improved procedural and clinical outcomes.
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Bioprótese , Substituição da Valva Aórtica Transcateter , Valva Aórtica/cirurgia , Humanos , Polônia , Desenho de Prótese , Sistema de Registros , Resultado do TratamentoRESUMO
Background: A severe prosthesis-patient mismatch (PPM) is associated with adverse outcomes following transcatheter aortic valve replacement (TAVR) for de novo aortic stenosis or a failed surgical bioprosthesis. The impact of severe PPM in patients undergoing TAV-in-TAVR is unknown. Aim: We sought to investigate the incidence and 1-year outcomes of different grades of PPM in patients undergoing TAV-in-TAVR. Materials and methods: The TRANSIT-PPM is an international registry, including cases of degenerated TAVR treated with a second TAVR. PPM severity, as well as in-hospital, 30-day, and 1-year outcomes were defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria. Results: Among 28 centers, 155 patients were included. Severe PPM was found in 6.5% of patients, whereas moderate PPM was found in 14.2% of patients. The rate of severe PPM was higher in patients who underwent TAV-in-TAVR with a second supra-annular self-expanding (S-SE) TAVR (10%, p = 0.04). Specifically, the rate of severe PPM was significantly higher among cases of a SE TAVR implanted into a balloon-expandable (BE) device (19%, p = 0.003). At 1-year follow-up, the rate of all-cause mortality, and the rate of patients in the New York Heart Association (NYHA) class III/IV were significantly higher in the cohort of patients with severe PPM (p = 0.016 and p = 0.0001, respectively). Almost all the patients with a severe PPM after the first TAVR had a failed < 23 mm BE transcatheter heart valve (THV): the treatment with an S-SE resolved the severe PPM in the majority of the cases. Conclusion: After TAV-in-TAVR, in a fifth of the cases, a moderate or severe PPM occurred. A severe PPM is associated with an increased 1-year all-cause mortality. Clinical trial registration: [https://clinicaltrials.gov], identifier [NCT04500964].
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BACKGROUND: Among patients referred for cardiac surgery, atrial fibrillation (AF) is a common comorbidity and a risk factor for postoperative arrhythmias (eg, sinus node dysfunction, atrioventricular heart block), including those requiring permanent pacemaker (PPM) implantation. OBJECTIVE: The purpose of this study was to evaluate the prevalence and long-term survival of postoperative PPM implantation in patients with preoperative AF who underwent valve surgery with or without concomitant procedures. METHODS: Presented analysis pertains to the HEIST (HEart surgery In atrial fibrillation and Supraventricular Tachycardia) registry. During the study period, 11,949 patients underwent valvular (aortic, mitral, or tricuspid valve replacement or repair) surgery and/or surgical ablation (SA) and were stratified according to postoperative PPM status. RESULTS: PPM implantation after surgery was necessary in 2.5% of patients, with significant variation depending on the type of surgery (from 1.1% in mitral valve repair to 3.3% in combined mitral and tricuspid valve surgery). In a multivariate logistic regression model, tricuspid intervention (P <.001), cardiopulmonary bypass time (P = .024), and endocarditis (P = .014) were shown to be risk factors for PPM. Over long-term follow-up, PPM was not associated with increased mortality compared to no PPM (hazard ratio 0.96; 95% confidence interval 0.77-1.19; P = .679). SA was not associated with PPM implantation. However, SA improved survival regardless of PPM status (log rank P <.001). CONCLUSION: In patients with preoperative AF, the need for PPM implantation after valve surgery or SA is not an infrequent outcome, with SA not affecting its prevalence but actually improving long-term survival.
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Fibrilação Atrial , Procedimentos Cirúrgicos Cardíacos , Implante de Prótese de Valva Cardíaca , Marca-Passo Artificial , Fibrilação Atrial/complicações , Fibrilação Atrial/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Valva Mitral/cirurgia , Estudos Retrospectivos , Fatores de Risco , Resultado do TratamentoRESUMO
Objectives: Although endorsed by international guidelines, complete revascularization (CR) with Coronary Artery Bypass Grafting (CABG) remains underused. In higher-risk patients such as those with pre-operative atrial fibrillation (AF), the effects of CR are not well studied. Methods: We analyzed patients' data from the HEIST (HEart surgery In AF and Supraventricular Tachycardia) registry. Between 2012 and 2020 we identified 4770 patients with pre-operative AF and multivessel coronary artery disease who underwent isolated CABG. We divided the cohort according to the completeness of the revascularization and used propensity score matching (PSM) to minimize differences between baseline characteristics. The primary endpoint was all-cause mortality. Results: Median follow-up was 4.7 years [interquartile range (IQR) 2.3-6.9]. PSM resulted in 1,009 pairs of complete and incomplete revascularization. Number of distal anastomoses varied, accounting for 3.0 + -0.6 vs. 1.7 + -0.6, respectively. Although early (< 24 h) and 30-day post-operative mortalities were not statistically different between non-CR and CR patients [Odds Ratio (OR) and 95% Confidence Intervals (CIs): 1.34 (0.46-3.86); P = 0.593, Hazard Ratio (HR) and 95% CIs: 0.88 (0.59-1.32); P = 0.542, respectively] the long term mortality was nearly 20% lower in the CR cohort [HR (95% CIs) 0.83 (0.71-0.96); P = 0.011]. This benefit was sustained throughout subgroup analyses, yet most accentuated in low-risk patients (younger i.e., < 70 year old, with a EuroSCORE II < 2%, non-diabetic) and when off-pump CABG was performed. Conclusion: Complete revascularization in patients with pre-operative AF is safe and associated with improved survival. Particular survival benefit with CR was observed in low-risk patients undergoing off-pump CABG.
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Cerebral embolic protection (CEP) devices aim to reduce the risk of periprocedural cerebrovascular events during transcatheter aortic valve implantation (TAVI). Here, the authors describe the first-in-human experience with the ProtEmbo Cerebral Protection System (Protembis), a next-generation CEP device, during TAVI. This case is part of a larger European trial evaluating the safety and performance of this device. After deployment of the ProtEmbo in the aortic arch, a first transcatheter heart valve was implanted. Despite postdilatation, moderate to severe aortic regurgitation persisted. The operating team decided to perform a valve-in-valve procedure using a second transcatheter heart valve. The ProtEmbo demonstrated good coverage of all three head vessels and no interaction with TAVI catheters in the aortic arch throughout the entire procedure. No adverse events were observed during hospitalisation or follow-up, and there was a significant reduction in aortic regurgitation at follow-up echocardiography. Despite a challenging overall procedure with presumably high embolic burden, diffusion-weighted MRI at follow-up showed a low number (n=3) and volume (156 mm3) of new hyperintense lesions. The first-in-human use of the ProtEmbo was safe and feasible, despite a challenging TAVI valve-in-valve procedure.