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BACKGROUND: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study. METHODS: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year. RESULTS: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients. CONCLUSIONS: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801.
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Bioprótese , Cateterismo Cardíaco , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Valva Mitral , Desenho de Prótese , Falha de Prótese , Recuperação de Função Fisiológica , Humanos , Feminino , Masculino , Valva Mitral/cirurgia , Valva Mitral/fisiopatologia , Valva Mitral/diagnóstico por imagem , Idoso , Estudos Prospectivos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/mortalidade , Fatores de Tempo , Resultado do Tratamento , Fatores de Risco , Pessoa de Meia-Idade , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/mortalidade , Medição de Risco , Idoso de 80 Anos ou mais , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/mortalidade , Estados Unidos , Estenose da Valva Mitral/cirurgia , Estenose da Valva Mitral/fisiopatologia , Estenose da Valva Mitral/mortalidade , Estenose da Valva Mitral/diagnóstico por imagem , Hemodinâmica , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidadeRESUMO
Background: Periprocedural myocardial injury (PPMI) frequently occurs after transcatheter aortic valve implantation (TAVI), although its impact on long-term mortality is uncertain. Methods: We performed a pooled analysis of Kaplan-Meier-derived individual patient data to compare survival in patients with and without PPMI after TAVI. Flexible parametric models with B-splines and landmark analyses were used to determine PPMI prognostic value. Subgroup analyses for VARC-2, troponin, and creatine kinase-MB (CK-MB)-defined PPMI were also performed. Results: Eighteen observational studies comprising 10,094 subjects were included. PPMI was associated with lower overall survival (OS) after two years (HR = 1.46, 95% CI 1.30-1.65, p < 0.01). This was also observed when restricting the analysis to overall VARC-2-defined PPMI (HR = 1.23, 95% CI 1.07-1.40, p < 0.01). For VARC-2 PPMI criteria and VARC-2 troponin-only, higher mortality was restricted to the first 2 months after TAVI (HR = 1.64, 95% CI 1.31-2.07, p < 0.01; and HR = 1.32, 95% CI 1.05-1.67, p = 0.02, respectively), while for VARC-2 defined CK-MB-only the increase in mortality was confined to the first 30 days (HR = 7.44, 95% CI 4.76-11.66, p < 0.01). Conclusion: PPMI following TAVI was associated with lower overall survival compared with patients without PPMI. PPMI prognostic impact is restricted to the initial months after the procedure. The analyses were consistent for VARC-2 criteria and for both biomarkers, yet CK-MB was a stronger prognostic marker of mortality than troponin.
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BACKGROUND: The subxiphoid pericardial access is technically difficult and has a considerable rate of complications, thus transatrial access may be an alternative. OBJECTIVES: This study sought to assess the feasibility and safety of this strategy regarding periprocedural period and after 1-week follow-up. METHODS: The investigators performed epicardial mapping through transatrial puncture in 20 swine. Animals were divided into group A, in which aspiration of the sheath was performed to maintain negative pressure after the withdraw of the catheters, and group B, in which a device (Konar-MF VSD Occluder) was delivered to occlude the right atrial appendage perforation. Bleeding was investigated immediately and 1 week after. RESULTS: Access was safe in 19 of 20 animals (95%) with small amount of bleeding (6.4 ± 6 mL). In group A (n = 10), 1 animal presented hemopericardium right after the puncture. In the other 9, epicardial ablation was performed and 60.0 ± 28.0 mL of blood was aspirated without events. After 1 week, fibrin-hemorrhagic pericarditis was identified in 3 animals. In group B (n = 10), reaching the epicardial surface was possible in all animals. An adequate position of the prosthesis was obtained in 90% (9 of 10). One death occurred in the immediate postoperative period, secondary to pneumothorax. After 1 week, postmortem analysis showed absence of pericardial bleeding and a normal-appearing pericardium in the 8 animals with adequate prosthesis position. CONCLUSIONS: Transatrial access allows epicardial mapping and ablation. Sheath removal after negative pressure contributes to achieving acute bleeding control but does not prevent its occurrence. The use of the device prevents bleeding and hemorrhagic pericarditis.
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Mapeamento Epicárdico , Pericardite , Animais , Suínos , Estudos de Viabilidade , Mapeamento Epicárdico/métodos , Pericárdio/cirurgia , Hemorragia/etiologiaRESUMO
Background: Acute kidney injury (AKI) is frequently observed after transcatheter aortic valve implantation (TAVI). Of note, it is associated with a threefold increase in all-cause and cardiac death. We propose a new non-contrast strategy for evaluating and performing the TAVI procedure that can be especially valuable for patients with aortic stenosis (AS) and chronic kidney disease (CKD) to prevent AKI. Methods: Patients with severe symptomatic AS and CKD stage ≥3a were evaluated for TAVI using four non-contrast imaging modalities for procedural planning: transesophageal echocardiogram (TEE), cardiac magnetic resonance, multidetector computed tomography (MDCT), and aortoiliac CO2 angiography. Patients underwent transfemoral (TF) TAVI using the self-expandable Evolut R/Pro, and the procedures were guided by fluoroscopy and TEE. Contrast MDCT and contrast injection at certain checkpoints during the procedure were used in a blinded fashion to guarantee patient safety. Results: A total of 25 patients underwent TF-TAVI with the zero-contrast technique. The mean age was 79.9 ± 6.1 years, 72% in NYHA class III/IV, with a mean STS-PROM of 3.0% ± 1.5%, and creatinine clearance of 49 ± 7 ml/min. The self-expandable Evolut R and Pro were implanted in 80% and 20% of patients, respectively. In 36% of the cases, the transcatheter heart valve (THV) chosen was one size larger than the one by contrast MDCT, but none of these cases presented adverse events. Device success and the combined safety endpoint (at 30 days) both achieved 92%. Pacemaker implantation was needed in 17%. Conclusion: This pilot study demonstrated that the zero-contrast technique for procedural planning and THV implantation was feasible and safe and might become the preferable strategy for a significant population of CKD patients undergoing TAVR. Future studies with a larger number of patients are still needed to confirm such interesting findings.
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Introduction: Classical low-flow, low-gradient aortic stenosis (LFLG-AS) is an advanced stage of aortic stenosis, which has a poor prognosis with medical treatment and a high operative mortality after surgical aortic valve replacement (SAVR). There is currently a paucity of information regarding the current prognosis of classical LFLG-AS patients undergoing SAVR and the lack of a reliable risk assessment tool for this particular subset of AS patients. The present study aims to assess mortality predictors in a population of classical LFLG-AS patients undergoing SAVR. Methods: This is a prospective study including 41 consecutive classical LFLG-AS patients (aortic valve area ≤1.0â cm2, mean transaortic gradient <40â mmHg, left ventricular ejection fraction <50%). All patients underwent dobutamine stress echocardiography (DSE), 3D echocardiography, and T1 mapping cardiac magnetic resonance (CMR). Patients with pseudo-severe aortic stenosis were excluded. Patients were divided into groups according to the median value of the mean transaortic gradient (≤25 and >25â mmHg). All-cause, intraprocedural, 30-day, and 1-year mortality rates were evaluated. Results: All of the patients had degenerative aortic stenosis, with a median age of 66 (60-73) years; most of the patients were men (83%). The median EuroSCORE II was 2.19% (1.5%-4.78%), and the median STS was 2.19% (1.6%-3.99%). On DSE, 73.2% had flow reserve (FR), i.e., an increase in stroke volume ≥20% during DSE, with no significant differences between groups. On CMR, late gadolinium enhancement mass was lower in the group with mean transaortic gradient >25â mmHg [2.0 (0.0-8.9)â g vs. 8.5 (2.3-15.0)â g; p = 0.034), and myocardium extracellular volume (ECV) and indexed ECV were similar between groups. The 30-day and 1-year mortality rates were 14.6% and 43.8%, respectively. The median follow-up was 4.1 (0.3-5.1)â years. By multivariate analysis adjusted for FR, only the mean transaortic gradient was an independent predictor of mortality (hazard ratio: 0.923, 95% confidence interval: 0.864-0.986, p = 0.019). A mean transaortic gradient ≤25â mmHg was associated with higher all-cause mortality rates (log-rank p = 0.038), while there was no difference in mortality regarding FR status (log-rank p = 0.114). Conclusions: In patients with classical LFLG-AS undergoing SAVR, the mean transaortic gradient was the only independent mortality predictor in patients with LFLG-AS, especially if ≤25â mmHg. The absence of left ventricular FR had no prognostic impact on long-term outcomes.
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Background No study has evaluated the impact of the additional manipulation demanded by multiple resheathing (MR) in patients undergoing transcatheter aortic valve replacement with repositionable self-expanding valves. Methods and Results This study included a real-world, multicenter registry involving 16 centers from Canada, Germany, Latin America, and Spain. All consecutive patients who underwent transcatheter aortic valve replacement with the Evolut R, Evolut PRO, and Portico valves were included. Patients were divided according to the number of resheathing: no resheathing, single resheathing (SR), and MR. The primary end point was device success. Secondary outcomes included procedural complications, early safety events, and 1-year mortality. In 1026 patients, the proportion who required SR and MR was 23.9% and 9.3%, respectively. MR was predicted by the use of Portico and moderate/severe aortic regurgitation at baseline (both with P<0.01). Patients undergoing MR had less device success (no resheathing=89.9%, SR=89.8%, and MR=80%; P=0.01), driven by more need for a second prosthesis and device embolization. At 30 days, there were no differences in safety events. At 1 year, more deaths occurred with MR (no resheathing=10.5%, SR=8.0%, and MR=18.8%; P=0.014). After adjusting for baseline differences and center experience by annual volume, MR associated with less device success (odds ratio, 0.42; P=0.003) and increased 1-year mortality (hazard ratio, 2.06; P=0.01). When including only the Evolut R/PRO cases (N=837), MR continued to have less device success (P<0.001) and a trend toward increased mortality (P=0.05). Conclusions Repositioning a self-expanding valve is used in a third of patients, being multiple in ≈10%. MR, but not SR, was associated with more device failure and higher 1-year mortality, regardless of the type of valve implanted.
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Substituição da Valva Aórtica Transcateter , Catéteres , Humanos , Incidência , Razão de Chances , Sistema de Registros , Substituição da Valva Aórtica Transcateter/efeitos adversosRESUMO
Background: Bioprosthetic heart valve has limited durability and lower long-term performance especially in rheumatic heart disease (RHD) patients that are often subject to multiple redo operations. Minimally invasive procedures, such as transcatheter valve-in-valve (ViV) implantation, may offer an attractive alternative, although data is lacking. The aim of this study was to evaluate the baseline characteristics and clinical outcomes in rheumatic vs. non-rheumatic patients undergoing ViV procedures for severe bioprosthetic valve dysfunction. Methods: Single center, prospective study, including consecutive patients undergoing transcatheter ViV implantation in aortic, mitral and tricuspid position, from May 2015 to September 2020. RHD was defined according to clinical history, previous echocardiographic and surgical findings. Results: Among 106 patients included, 69 had rheumatic etiology and 37 were non-rheumatic. Rheumatic patients had higher incidence of female sex (73.9 vs. 43.2%, respectively; p = 0.004), atrial fibrillation (82.6 vs. 45.9%, respectively; p < 0.001), and 2 or more prior surgeries (68.1 vs. 32.4%, respectively; p = 0.001). Although, device success was similar between groups (75.4 vs. 89.2% in rheumatic vs. non-rheumatic, respectively; p = 0.148), there was a trend toward higher 30-day mortality rates in the rheumatic patients (21.7 vs. 5.4%, respectively; p = 0.057). Still, at median follow-up of 20.7 [5.1-30.4] months, cumulative mortality was similar between both groups (p = 0.779). Conclusion: Transcatheter ViV implantation is an acceptable alternative to redo operations in the treatment of patients with RHD and severe bioprosthetic valve dysfunction. Despite similar device success rates, rheumatic patients present higher 30-day mortality rates with good mid-term clinical outcomes. Future studies with a larger number of patients and follow-up are still warranted, to firmly conclude on the role transcatheter ViV procedures in the RHD population.
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BACKGROUND: Procedural improvements combined with the contemporary clinical profile of patients undergoing transcatheter aortic valve replacement (TAVR) may have influenced the incidence and outcomes of infective endocarditis (IE) following TAVR. We aimed to determine the temporal trends, characteristics, and outcomes of IE post-TAVR. METHODS: Observational study including 552 patients presenting definite IE post-TAVR. Patients were divided in 2 groups according to the timing of TAVR (historical cohort [HC]: before 2014; contemporary cohort [CC]: after 2014). RESULTS: Overall incidence rates of IE were similar in both cohorts (CC vs HC: 5.45 vs 6.52 per 1000 person-years; Pâ =â .12), but the rate of early IE was lower in the CC (2.29 vs 4.89, Pâ <â .001). Enterococci were the most frequent microorganism. Most patients presented complicated IE ( CC: 67.7%; HC: 69.6%; Pâ =â .66), but the rate of surgical treatment remained low (CC: 20.7%; HC: 17.3%; Pâ =â .32). The CC exhibited lower rates of in-hospital acute kidney injury (35.1% vs 44.6%; Pâ =â .036) and in-hospital (26.6% vs 36.4%; Pâ =â .016) and 1-year (37.8% vs 53.5%; Pâ <â .001) mortality. Higher logistic EuroScore, Staphylococcus aureus etiology, and complications (stroke, heart failure, and acute renal failure) were associated with in-hospital mortality in multivariable analyses (Pâ <â .05 for all). CONCLUSIONS: Although overall IE incidence has remained stable, the incidence of early IE has declined in recent years. The microorganism, high rate of complications, and very low rate of surgical treatment remained similar. In-hospital and 1-year mortality rates were high but progressively decreased over time.
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Endocardite Bacteriana , Endocardite , Substituição da Valva Aórtica Transcateter , Endocardite/epidemiologia , Endocardite/etiologia , Endocardite/cirurgia , Endocardite Bacteriana/epidemiologia , Endocardite Bacteriana/etiologia , Endocardite Bacteriana/cirurgia , Humanos , Incidência , Complicações Pós-Operatórias/epidemiologia , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
OBJECTIVE: The present study evaluated the effect of endovascular administration of calcium chloride to the carotid artery of swines, to create a model of arterial calcification. METHODS: Fifteen Large White pigs were used for the study. Via endovascular treatment, carotid arteries were exposed during 9 min to either calcium chloride (experimental artery) or saline (control artery) with the use of the TAPAS catheter. Intravascular ultrasound (IVUS) imaging was obtained at baseline, postprocedure and at 30 days. Optical coherence tomography (OCT) imaging was obtained in vitro after carotids were harvested. Longitudinally cut parallel arterial segments were placed in a system of delicate clamps and underwent uniaxial strain test. All arteries underwent histopathological examination. RESULTS: Calcium chloride treated segments showed extensive circumferential parietal calcification evident on both IVUS and OCT. Reduction in minimal lumen area on IVUS was evident in experimental arteries both at 24 hr and 30 days postprocedure. Histopathologic assessment (Von Kossa stain) confirmed medial calcification with mild intimal thickening. Biomechanical testing showed treated segments to have smaller breaking strength and less elastic deformation than controls. CONCLUSION: We developed a nonexpensive, reproducible model of early carotid medial calcification in pigs. Our model has the potential to help the development of research to unravel mechanisms underlying arterial calcification, the use of current or new devices to treat calcified lesions as well as to serve as an option for training interventionalists on the use of such devices.
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Cloreto de Cálcio , Doenças das Artérias Carótidas/induzido quimicamente , Artéria Carótida Primitiva/patologia , Calcificação Vascular/induzido quimicamente , Animais , Fenômenos Biomecânicos , Doenças das Artérias Carótidas/diagnóstico por imagem , Doenças das Artérias Carótidas/patologia , Artéria Carótida Primitiva/diagnóstico por imagem , Modelos Animais de Doenças , Elasticidade , Masculino , Neointima , Sus scrofa , Fatores de Tempo , Tomografia de Coerência Óptica , Ultrassonografia de Intervenção , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/patologiaRESUMO
OBJECTIVES: The aim of this study was to evaluate the predictors of left ventricular outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR). BACKGROUND: LVOT obstruction is a major concern with TMVR, but limited data exist regarding its predictors and impact on outcomes. METHODS: Patients with pre-procedural multidetector row computed tomography (MDCT) undergoing TMVR for failed mitral bioprosthetic valves (valve-in-valve), annuloplasty rings (valve-in-ring), and mitral annular calcification (valve-in-MAC) were included in this study. Echocardiographic and procedural characteristics were recorded, and comprehensive assessment with MDCT was performed to identify the predictors of LVOT obstruction (defined as an increment of mean LVOT gradient ≥10 mm Hg from baseline). The new LVOT (neo-LVOT) area left after TMVR was estimated by embedding a virtual valve into the mitral annulus on MDCT, simulating the procedure. RESULTS: Among 194 patients with pre-procedural MDCT undergoing TMVR (valve-in-valve, 107 patients; valve-in-ring, 50 patients; valve-in-MAC, 37 patients), LVOT obstruction was observed in 26 patients (13.4%), with a higher rate after valve-in-MAC than valve-in-ring and valve-in-valve (54.1% vs. 8.0% vs. 1.9%; p < 0.001). Patients with LVOT obstruction had significantly higher procedural mortality compared with those without LVOT obstruction (34.6% vs. 2.4%; p < 0.001). Receiver-operating characteristic curve analysis showed that an estimated neo-LVOT area ≤1.7 cm2 predicted LVOT obstruction with sensitivity of 96.2% and specificity of 92.3%. CONCLUSIONS: LVOT obstruction after TMVR was associated with higher procedural mortality. A small estimated neo-LVOT area was significantly associated with LVOT obstruction after TMVR and may help identify patients at high risk for LVOT obstruction.
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Calcinose/cirurgia , Cateterismo Cardíaco/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Insuficiência da Valva Mitral/cirurgia , Estenose da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Obstrução do Fluxo Ventricular Externo/etiologia , Idoso , Idoso de 80 Anos ou mais , Calcinose/diagnóstico por imagem , Calcinose/mortalidade , Calcinose/fisiopatologia , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/mortalidade , Ecocardiografia , Feminino , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/fisiopatologia , Estenose da Valva Mitral/diagnóstico por imagem , Estenose da Valva Mitral/mortalidade , Estenose da Valva Mitral/fisiopatologia , Tomografia Computadorizada Multidetectores , Desenho de Prótese , Falha de Prótese , Sistema de Registros , Medição de Risco , Fatores de Risco , Resultado do Tratamento , Obstrução do Fluxo Ventricular Externo/diagnóstico por imagem , Obstrução do Fluxo Ventricular Externo/mortalidade , Obstrução do Fluxo Ventricular Externo/fisiopatologiaRESUMO
Aims: We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. Methods and results: From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P < 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P < 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P < 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P < 0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P < 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; P = 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; P < 0.001]. Conclusion: The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.
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Bioprótese , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Anuloplastia da Valva Mitral , Valva Mitral/cirurgia , Falha de Prótese , Idoso , Idoso de 80 Anos ou mais , Calcinose/cirurgia , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Valva Mitral/patologia , Anuloplastia da Valva Mitral/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/mortalidade , Desenho de Prótese , Acidente Vascular Cerebral/etiologia , Resultado do TratamentoRESUMO
BACKGROUND: The impact of preexisting left bundle branch block (LBBB) in transcatheter aortic valve replacement (TAVR) recipients is unknown. The aim of this study was to determine the impact of preexisting LBBB on clinical outcomes after TAVR. METHODS AND RESULTS: This multicenter study evaluated 3404 TAVR candidates according to the presence or absence of LBBB on baseline ECG. TAVR complications and causes of death were defined according to Valve Academic Research Consortium-2 definitions. Follow-up outpatient visits or telephone interviews were conducted at 30 days, 12 months, and yearly thereafter. Echocardiography examinations were performed at baseline, at hospital discharge, and at 1-year follow-up. Preexisting LBBB was present in 398 patients (11.7%) and was associated with an increased risk of permanent pacemaker implantation (PPI; 21.1% versus 14.8%; adjusted odds ratio, 1.51; 95% CI, 1.12-2.04) but not death (7.3% versus 5.5%; adjusted odds ratio, 1.33; 95% CI, 0.84-2.12) at 30 days. At a mean follow-up of 22±21 months, there were no differences between patients with and without preexisting LBBB in overall mortality (adjusted hazard ratio, 0.94; 95% CI, 0.75-1.18) and cardiovascular mortality (adjusted hazard ratio, 0.90; 95% CI, 0.68-1.21). In a subanalysis of 2421 patients without PPI at 30 days and with complete follow-up about the PPI, preexisting LBBB was not associated with an increased risk of PPI or sudden cardiac death. Patients with preexisting LBBB had a lower left ventricular ejection fraction (LVEF) at baseline and at 1-year follow-up ( P <0.001 for both), but those with low LVEF exhibited a similar increase in LVEF over time after TAVR compared with patients with no preexisting LBBB ( P=0.327). CONCLUSIONS: Preexisting LBBB significantly increased the risk of early (but not late) PPI after TAVR, without any significant effect on overall mortality or cardiovascular mortality. Preexisting LBBB was associated with lower LVEF pre-TAVR but did not prevent an increase in LVEF post-TAVR similar to patients without LBBB.
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Valva Aórtica/cirurgia , Bloqueio de Ramo/terapia , Estimulação Cardíaca Artificial , Doenças das Valvas Cardíacas/cirurgia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Brasil/epidemiologia , Bloqueio de Ramo/diagnóstico , Bloqueio de Ramo/mortalidade , Bloqueio de Ramo/fisiopatologia , Canadá/epidemiologia , Estimulação Cardíaca Artificial/efeitos adversos , Estimulação Cardíaca Artificial/mortalidade , Ecocardiografia , Eletrocardiografia , Europa (Continente)/epidemiologia , Feminino , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/mortalidade , Doenças das Valvas Cardíacas/fisiopatologia , Humanos , Masculino , Marca-Passo Artificial , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do TratamentoRESUMO
OBJECTIVES: This study sought to assess the influence of baseline right bundle branch block (RBBB) on all-cause and cardiovascular mortality as well as sudden cardiac death (SCD) among patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Few data exist regarding the late clinical impact of pre-existing RBBB in TAVR recipients. METHODS: A total of 3,527 patients (mean age 82 ± 8 years, 50.1% men) were evaluated according to the presence of RBBB on baseline electrocardiography. Intraventricular conduction abnormalities were classified according to the American Heart Association, American College of Cardiology Foundation, and Heart Rhythm Society recommendations for standardization and interpretation of the electrocardiogram. TAVR complications and causes of death were defined according to Valve Academic Research Consortium 2 definitions. RESULTS: RBBB was present on baseline electrocardiography in 362 patients (10.3%) and associated with higher 30-day rates of permanent pacemaker implantation (PPI) (40.1% vs. 13.5%; p < 0.001) and death (10.2% vs. 6.9%; p = 0.024). At a mean follow-up of 20 ± 18 months, pre-existing RBBB was independently associated with all-cause mortality (hazard ratio [HR]: 1.31; 95% confidence interval [CI]: 1.06 to 1.63; p = 0.014) and cardiovascular mortality (HR: 1.45; 95% CI: 1.11 to 1.89; p = 0.006) but not with SCD (HR: 0.71; 95% CI: 0.22 to 2.32; p = 0.57). Patients with pre-existing RBBB and without PPI at discharge from the index hospitalization had the highest 2-year risk for cardiovascular death (27.8%; 95% CI: 20.9% to 36.1%; log-rank p = 0.007). In a subanalysis of 1,245 patients without PPI at discharge from the index hospitalization and with complete follow-up regarding the need for PPI, pre-existing RBBB was independently associated with the composite of SCD and PPI (HR: 2.68; 95% CI: 1.16 to 6.17; p = 0.023). CONCLUSIONS: Pre-existing RBBB was found in 10% of TAVR recipients and was associated with poorer clinical outcomes. Patients with baseline RBBB without permanent pacemakers at hospital discharge may be at especially high risk for high-degree atrioventricular block and/or SCD during follow-up. Future studies should evaluate strategies aimed at the early detection of patients at risk for late development of high-degree atrioventricular block.
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Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bloqueio de Ramo/mortalidade , Morte Súbita Cardíaca/epidemiologia , Substituição da Valva Aórtica Transcateter/mortalidade , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Brasil/epidemiologia , Bloqueio de Ramo/diagnóstico , Bloqueio de Ramo/fisiopatologia , Canadá/epidemiologia , Causas de Morte , Ecocardiografia , Eletrocardiografia , Europa (Continente)/epidemiologia , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Análise Multivariada , Modelos de Riscos Proporcionais , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: We aimed to determine the incidence, predictors, clinical characteristics, management, and outcomes of infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: This multicenter registry included 53 patients (mean age, 79±8 years; men, 57%) who suffered IE after TAVI of 7944 patients after a mean follow-up of 1.1±1.2 years (incidence, 0.67%, 0.50% within the first year after TAVI). Mean time from TAVI was 6 months (interquartile range, 1-14 months). Orotracheal intubation (hazard ratio, 3.87; 95% confidence interval, 1.55-9.64; P=0.004) and the self-expandable CoreValve system (hazard ratio, 3.12; 95% confidence interval, 1.37-7.14; P=0.007) were associated with IE (multivariate analysis including 3067 patients with individual data). The most frequent causal microorganisms were coagulase-negative staphylococci (24%), followed by Staphylococcus aureus (21%) and enterococci (21%). Vegetations were present in 77% of patients (transcatheter valve leaflets, 39%; stent frame, 17%; mitral valve, 21%). At least 1 complication of IE occurred in 87% of patients (heart failure in 68%). However, only 11% of patients underwent valve intervention (valve explantation and valve-in-valve procedure in 4 and 2 patients, respectively). The mortality rate in hospital was 47.2% and increased to 66% at the 1-year follow-up. IE complications such as heart failure (P=0.037) and septic shock (P=0.002) were associated with increased in-hospital mortality. CONCLUSIONS: The incidence of IE at 1 year after TAVI was 0.50%, and the risk increased with the use of orotracheal intubation and a self-expandable valve system. Staphylococci and enterococci were the most common agents. Although most patients presented at least 1 complication of IE, valve intervention was performed in a minority of patients, and nearly half of the patients died during the hospitalization period.
Assuntos
Endocardite Bacteriana/etiologia , Próteses Valvulares Cardíacas/efeitos adversos , Complicações Pós-Operatórias/etiologia , Infecções Relacionadas à Prótese/etiologia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/cirurgia , Endocardite Bacteriana/mortalidade , Endocardite Bacteriana/cirurgia , Enterococcus , Contaminação de Equipamentos , Feminino , Infecções por Bactérias Gram-Positivas/etiologia , Infecções por Bactérias Gram-Positivas/cirurgia , Insuficiência Cardíaca/etiologia , Mortalidade Hospitalar , Humanos , Incidência , Intubação Intratraqueal/efeitos adversos , Estimativa de Kaplan-Meier , Masculino , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/cirurgia , Modelos de Riscos Proporcionais , Infecções Relacionadas à Prótese/mortalidade , Infecções Relacionadas à Prótese/cirurgia , Sistema de Registros , Estudos Retrospectivos , Risco , Infecções Estafilocócicas/etiologia , Infecções Estafilocócicas/cirurgia , Resultado do TratamentoRESUMO
BACKGROUND: Little evidence exists of the burden and predictors of cardiac death after transcatheter aortic valve replacement (TAVR). OBJECTIVES: The purpose of this study was to assess the incidence and predictors of cardiac death from advanced heart failure (HF) and sudden cardiac death (SCD) in a large patient cohort undergoing TAVR. METHODS: The study included a total of 3,726 patients who underwent TAVR using balloon (57%) or self-expandable (43%) valves. Causes of death were defined according to the Valve Academic Research Consortium-2. RESULTS: At a mean follow-up of 22 ± 18 months, 155 patients had died due to advanced HF (15.2% of total deaths, 46.1% of deaths from cardiac causes) and 57 had died due to SCD (5.6% of deaths, 16.9% of cardiac deaths). Baseline comorbidities (chronic obstructive pulmonary disease, atrial fibrillation, left ventricular ejection fraction ≤40%, lower mean transaortic gradient, pulmonary artery systolic pressure >60 mm Hg; p < 0.05 for all) and 2 procedural factors (transapical approach, hazard ratio [HR]: 2.38, 95% confidence interval [CI]: 1.60 to 3.54; p < 0.001; presence of moderate or severe aortic regurgitation after TAVR, HR: 2.79, 95% CI: 1.82 to 4.27; p < 0.001) independently predicted death from advanced HF. Left ventricular ejection fraction ≤40% (HR: 1.93, 95% CI: 1.05 to 3.55; p = 0.033) and new-onset persistent left bundle-branch block following TAVR (HR: 2.26, 95% CI: 1.23 to 4.14; p = 0.009) were independently associated with an increased risk of SCD. Patients with new-onset persistent left bundle-branch block and a QRS duration >160 ms had a greater SCD risk (HR: 4.78, 95% CI: 1.56 to 14.63; p = 0.006). CONCLUSIONS: Advanced HF and SCD accounted for two-thirds of cardiac deaths in patients after TAVR. Potentially modifiable or treatable factors leading to increased risk of mortality for HF and SCD were identified. Future studies should determine whether targeting these factors decreases the risk of cardiac death.
Assuntos
Morte Súbita Cardíaca/epidemiologia , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/mortalidade , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/mortalidade , Substituição da Valva Aórtica Transcateter/mortalidade , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Insuficiência Cardíaca/epidemiologia , Humanos , Incidência , Masculino , Complicações Pós-Operatórias/epidemiologia , Valor Preditivo dos Testes , Resultado do TratamentoRESUMO
BACKGROUND: There are innumerous indicators to assure the quality of a service. However, medical competence and the proper performance of a procedure determine its final quality. The Brazilian Society of Cardiac Arrhythmias recommends minimum parameters necessary to guarantee the excellence of ambulatory electrocardiographic monitoring services. OBJECTIVE: To recommend minimum medical competences and the information required to issue a Holter monitoring report. METHODS: This study was grounded in the concept of evidence-based medicine and, when evidence was not available, the opinion of a writing committee was used to formulate the recommendation. That committee consisted of professionals with experience on the difficulties of the method and management in providing services in that area. RESULTS: The professional responsible for the Holter monitoring analysis should know cardiovascular pathologies and have consistent formation on electrocardiography, including cardiac arrhythmias and their differential diagnoses. The report should be written in a clear and objective way. The minimum parameters that comprise a Holter report should include statistics of the exam, as well as quantification and analysis of the rhythm disorders observed during monitoring. CONCLUSION: Ambulatory electrocardiographic monitoring should be performed by professionals knowledgeable about electrocardiographic analysis, whose report should comprise the minimum parameters mentioned in this document.
Assuntos
Arritmias Cardíacas/diagnóstico , Eletrocardiografia Ambulatorial/normas , Medicina Baseada em Evidências , Brasil , Cardiologia/normas , Humanos , Sociedades Médicas/normasRESUMO
BACKGROUND: Aortic root rupture is a major concern with balloon-expandable transcatheter aortic valve replacement (TAVR). We sought to identify predictors of aortic root rupture during balloon-expandable TAVR by using multidetector computed tomography. METHODS AND RESULTS: Thirty-one consecutive patients who experienced left ventricular outflow tract (LVOT)/annular/aortic contained/noncontained rupture during TAVR were collected from 16 centers. A caliper-matched sample of 31 consecutive patients without annular rupture, who underwent pre-TAVR multidetector computed tomography served as a control group. Multidetector computed tomography assessment included short- and long-axis diameters and cross-sectional area of the sinotubular junction, annulus, and LVOT, and the presence, location, and extent of calcification of the LVOT, as well. There were no significant differences between the 2 groups in any preoperative clinical and echocardiographic variables. Aortic root rupture was identified in 20 patients and periaortic hematoma in 11. Patients with root rupture had a higher degree of subannular/LVOT calcification quantified by the Agatston score (181.2±211.0 versus 22.5±37.6, P<0.001), and a higher frequency of ≥20% annular area oversizing (79.4% versus 29.0%, P<0.001) and balloon postdilatation (22.6% versus 0.0%, P=0.005). In conditional logistic regression analysis for the matched data, moderate/severe LVOT/subannular calcifications (odds ratio, 10.92; 95% confidence interval, 3.23-36.91; P<0.001) and prosthesis oversizing ≥20% (odds ratio, 8.38; 95% confidence interval, 2.67-26.33; P<0.001) were associated with aortic root contained/noncontained rupture. CONCLUSIONS: This study demonstrates that LVOT calcification and aggressive annular area oversizing are associated with an increased risk of aortic root rupture during TAVR with balloon-expandable prostheses. Larger studies are warranted to confirm these findings.
Assuntos
Angioplastia com Balão/efeitos adversos , Ruptura Aórtica/etiologia , Estenose da Valva Aórtica/terapia , Cateterismo Cardíaco , Implante de Prótese de Valva Cardíaca/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Ruptura Aórtica/diagnóstico por imagem , Ruptura Aórtica/epidemiologia , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/epidemiologia , Calcinose/complicações , Calcinose/diagnóstico por imagem , Calcinose/epidemiologia , Estudos de Coortes , Feminino , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Modelos Logísticos , Masculino , Valor Preditivo dos Testes , Fatores de Risco , Tomografia Computadorizada por Raios XRESUMO
BACKGROUND: Several mechanisms may be involved in the trigger of syncope in patients with hypertrophic cardiomyopathy (HCM), including hemodynamic collapses that might be related to an autonomic imbalance. OBJECTIVE: To evaluate and compare the autonomic function of patients presenting HCM with unexplained syncope (US) to those without syncope. METHODS: Thirty-seven patients were included, 16 with US and 21 without syncope. Their autonomic function was assessed by spontaneous and phenylephrine induced baroreflex sensitivity (BRS), by heart rate variability (HRV) in time domain during 24-hour Holter and in frequency domain (spectral analysis), both in supine position and at 70º head-up tilt (HUT). RESULTS: The spontaneous BRS was similar in both groups (16,46 ± 12,99 vs. 18,31 ± 9,88 ms/mmHg, p = 0,464), as was phenylephrine-induced BRS (18,33 ± 9,31 vs. 15,83 ± 15,48 ms/mmHg, p = 0,521). No differences were observed in SDNN (137,69 ± 36,62 vs . 145,95 ± 38,07 ms, p=0,389). The group presenting syncope had a significantly lower RMSSD (24,88±10,03 vs. 35,58 ± 16,43 ms, p = 0,042) and a tendency to lower pNN50 (4,51 ± 3,78 vs . 8,83 ± 7,98%, p =0,085) and lower values of the high frequency component of HRV spectral analysis at rest (637,59±1.295,53 vs. 782,65±1.264,14ms2, p=0,075). No significant difference was observed in response to HUT (p = 0,053). HUT sensitivity, specificity and accuracy in identifying the etiology of US in HCM patients were 6%, 66% and 40%, respectively. CONCLUSIONS: A lower parasympathetic tone was observed in HCM patients with US, but the clinical relevance of this finding remains unclear. HUT is not a valuable tool for evaluating the origin of syncope in these patients, mainly because of its poor specificity.