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BACKGROUND: Mitral valve transcatheter edge-to-edge repair (M-TEER) is an effective option for treatment of mitral regurgitation (MR). We previously reported favorable 2-year outcomes for the PASCAL transcatheter valve repair system. OBJECTIVES: We report 3-year outcomes from the multinational, prospective, single-arm CLASP study with analysis by functional MR (FMR) and degenerative MR (DMR). METHODS: Patients with core-lab determined MR ≥ 3+ were deemed candidates for M-TEER by the local heart team. Major adverse events were assessed by an independent clinical events committee to 1 year and by sites thereafter. Echocardiographic outcomes were evaluated by the core laboratory to 3 years. RESULTS: The study enrolled 124 patients, 69% FMR; 31% DMR (60% NYHA class III-IVa, 100% MR ≥ 3+). The 3-year Kaplan-Meier estimate for survival was 75% (66% FMR; 92% DMR) and freedom from heart failure hospitalization (HFH) was 73% (64% FMR; 91% DMR), with 85% reduction in annualized HFH rate (81% FMR; 96% DMR) (p < 0.001). MR ≤ 2+ was achieved and maintained in 93% of patients (93% FMR; 94% DMR) and MR ≤ 1+ in 70% of patients (71% FMR; 67% DMR) (p < 0.001). The mean left ventricular end-diastolic volume (181 mL at baseline) decreased progressively by 28 mL [p < 0.001]. NYHA class I/II was achieved in 89% of patients (p < 0.001). CONCLUSIONS: The 3-year results from the CLASP study demonstrated favorable and durable outcomes with the PASCAL transcatheter valve repair system in patients with clinically significant MR. These results add to the growing body of evidence establishing the PASCAL system as a valuable therapy for patients with significant symptomatic MR.
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Procedimentos Cirúrgicos Cardíacos , 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 , Estudos Prospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Accurate, timely ascertainment of clinical end points, particularly hospitalizations, is crucial for clinical trials. The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study extended the main TAILOR-PCI trial's follow-up to 2 years, using a smartphone-based research app featuring geofencing-triggered surveys and routine monthly mobile phone surveys to detect cardiovascular (CV) hospitalizations. This pilot study compared these digital tools to conventional site-coordinator ascertainment of CV hospitalizations. OBJECTIVE: The objectives were to evaluate geofencing-triggered notifications and routine monthly mobile phone surveys' performance in detecting CV hospitalizations compared to telephone visits and health record reviews by study coordinators at each site. METHODS: US and Canadian participants from the TAILOR-PCI Digital Follow-Up Study were invited to download the Eureka Research Platform mobile app, opting in for location tracking using geofencing, triggering a smartphone-based survey if near a hospital for ≥4 hours. Participants were sent monthly notifications for CV hospitalization surveys. RESULTS: From 85 participants who consented to the Digital Study, downloaded the mobile app, and had not previously completed their final follow-up visit, 73 (85.8%) initially opted in and consented to geofencing. There were 9 CV hospitalizations ascertained by study coordinators among 5 patients, whereas 8 out of 9 (88.9%) were detected by routine monthly hospitalization surveys. One CV hospitalization went undetected by the survey as it occurred within two weeks of the previous event, and the survey only allowed reporting of a single hospitalization. Among these, 3 were also detected by the geofencing algorithm, but 6 out of 9 (66.7%) were missed by geofencing: 1 occurred in a participant who never consented to geofencing, while 5 hospitalizations occurred among participants who had subsequently turned off geofencing prior to their hospitalization. Geofencing-detected hospitalizations were ascertained within a median of 2 (IQR 1-3) days, monthly surveys within 11 (IQR 6.5-25) days, and site coordinator methods within 38 (IQR 9-105) days. The geofencing algorithm triggered 245 notifications among 39 participants, with 128 (52.2%) from true hospital presence and 117 (47.8%) from nonhospital health care facility visits. Additional geofencing iterative improvements to reduce hospital misidentification were made to the algorithm at months 7 and 12, elevating the rate of true alerts from 35.4% (55 true alerts/155 total alerts before month 7) to 78.7% (59 true alerts/75 total alerts in months 7-12) and ultimately to 93.3% (14 true alerts/5 total alerts in months 13-21), respectively. CONCLUSIONS: The monthly digital survey detected most CV hospitalizations, while the geofencing survey enabled earlier detection but did not offer incremental value beyond traditional tools. Digital tools could potentially reduce the burden on study coordinators in ascertaining CV hospitalizations. The advantages of timely reporting via geofencing should be weighed against the issue of false notifications, which can be mitigated through algorithmic refinements.
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Intervenção Coronária Percutânea , Humanos , Clopidogrel/uso terapêutico , Seguimentos , Projetos Piloto , Canadá , HospitalizaçãoRESUMO
PURPOSE: Chronic kidney disease (CKD) is a risk factor for ischemic and bleeding events with dual antiplatelet therapy after percutaneous coronary intervention (PCI). Whether the presence of CYP2C19 loss of function (LOF) alleles modifies this risk, and whether a genotype-guided (GG) escalation of P2Y12 inhibitor therapy post PCI is safe in this population is unclear. METHODS: This was a post hoc analysis of randomized patients in TAILOR PCI. Patients were divided into two groups based on estimated glomerular filtration rate (eGFR) threshold of < 60 ml/min/1.73 m2 for CKD (n = 539) and non-CKD (n = 4276). The aggregate of cardiovascular death, stroke, myocardial infarction, stent thrombosis, and severe recurrent coronary ischemia at 12-months post-PCI was assessed as the primary endpoint. Secondary endpoint was major or minor bleeding. RESULTS: Mean (standard deviation) eGFR among patients with CKD was 49.5 (8.4) ml/min/1.72 m2. Among all patients, there was no significant interaction between randomized strategy and CKD status for any endpoint. Among LOF carriers, the interaction between randomized strategy and CKD status on composite ischemic outcome was not significant (p = 0.2). GG strategy was not associated with an increased risk of bleeding in either CKD group. CONCLUSIONS: In this exploratory analysis, escalation of P2Y12 inhibitor therapy following a GG strategy did not reduce the primary outcome in CKD. However, P2Y12 inhibitor escalation following a GG strategy was not associated with increased bleeding risk in CKD. Larger studies in CKD are needed. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01742117?term=TAILOR-PCI&draw=2&rank=1 . NCT01742117.
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Transcatheter mitral valve replacement has been successfully performed with the use of aortic transcatheter heart valves in hundreds of patients worldwide with severe dysfunction of a degenerated mitral bioprosthesis and high surgical risk for repeat operation. The delivery approach in the vast majority of the mitral valve-in-valve procedures has been transapical. Although the transseptal approach may be more technically challenging, it is less invasive and may be preferred by patients. Data from case series and a large international registry suggest that patients treated with transseptal mitral valve-in-valve have faster recovery, more improvement in left ventricular ejection fraction and possibly lower mortality compared with patients treated with transapical approach. A prospective clinical trial, the MITRAL trial (Mitral Implantation of TRAnscatheter vaLves) is evaluating the safety and feasibility of transvenous transseptal mitral valve-in-valve. The experience from this trial has allowed us to improve our procedural approach. In anticipation of a wider adoption of the transseptal approach for mitral valve-in-valve, we describe our current method step-by-step from planning the procedure through postprocedural management. This is an evolving technique that has changed with experience and the transition to newer generation transcatheter heart valve devices. We discuss the use of cardiac computed tomography for planning the procedure including transseptal puncture and valve size selection, provide procedural and technical tips, and discuss postprocedural care.
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Cateterismo Cardíaco/instrumentação , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Valva Mitral/cirurgia , Assistência Perioperatória/métodos , Falha de Prótese , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Tomada de Decisão Clínica , Ecocardiografia Doppler em Cores , Ecocardiografia Tridimensional , Ecocardiografia Transesofagiana , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/fisiopatologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Valva Mitral/diagnóstico por imagem , Valva Mitral/fisiopatologia , Seleção de Pacientes , Assistência Perioperatória/efeitos adversos , Valor Preditivo dos Testes , Desenho de Prótese , Recuperação de Função Fisiológica , Reoperação , Medição de Risco , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
The antegrade approach for aortic valve interventions is well known but has not been widely used for transcatheter aortic valve replacement (TAVR) procedures. We encountered a patient with no possibility of retrograde access due to a totally occluded abdominal aorta who had a failed attempt at apical TAVR. We describe antegrade TAVR despite occlusion of the abdominal aorta, with the arterial limb of the requisite veno-arterial loop created using bilateral arm access, a novel version of the previously described antegrade approach.
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Aorta Abdominal , Doenças da Aorta/complicações , Estenose da Valva Aórtica/terapia , Arteriopatias Oclusivas/complicações , Cateterismo Cardíaco , Implante de Prótese de Valva Cardíaca/métodos , Idoso , Aorta Abdominal/diagnóstico por imagem , Doenças da Aorta/diagnóstico , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico , Aortografia/métodos , Arteriopatias Oclusivas/diagnóstico , Valvuloplastia com Balão , Humanos , Masculino , Radiografia Intervencionista , Índice de Gravidade de Doença , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
Aortic insufficiency (AI) after transcatheter aortic valve replacement (TAVR) is difficult to manage when associated with congestive heart failure. AI after balloon aortic valvuloplasty (BAV) may be catastrophic, especially in patients who are not candidates for TAVR. We describe the use of urgent temporary pacing, followed by permanent pacing, to increase the heart rate to diminish diastolic filling time for the short term management of AI after BAV or TAVR. The strategy is particularly useful in patients who already have permanent pacemakers, which are common in this population.
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Insuficiência da Valva Aórtica/terapia , Estenose da Valva Aórtica/terapia , Valvuloplastia com Balão/efeitos adversos , Cateterismo Cardíaco/efeitos adversos , Estimulação Cardíaca Artificial/métodos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Idoso de 80 Anos ou mais , Aorta/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/fisiopatologia , Pressão Arterial , Cateterismo Cardíaco/métodos , Eletrocardiografia , Feminino , Frequência Cardíaca , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Masculino , Resultado do Tratamento , Função Ventricular Esquerda , Pressão VentricularRESUMO
BACKGROUND: Paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) is associated with less good outcomes. The use of percutaneous plugs is among the strategies to treat PVL after TAVR. Plugs have been limited by the need to pass 4-6 F delivery sheaths between the TAVR stent frame and the native valve leaflets. METHODS: The study population consists of six patients who had at least moderate aortic insufficiency (AI), and also developed symptoms of heart failure after TAVR. We describe in detail the use of low profile vascular plugs that require crossing the leaks with only a 4 F diagnostic catheter. RESULTS: Low profile vascular plugs were successfully deployed in all six patients without significant complications. Fluoroscopy time ranged 16.7-69.4 min (44.8 ± 18.8 min). Contrast volume ranged 15-100 mL (45 ± 34 mL). One plug was used in five, and two adjacent plus in one case. AI severity was reduced from moderate or severe to mild or less in four patients, from severe to moderate in one, and in one, there was no change. Five of six patients were treated electively and were significantly improved in terms of both echocardiographic PVL and also symptoms. The one who did not have echocardiographic improvement did not improve clinically and expired one month later. CONCLUSIONS: PVL closure can be consistently accomplished after TAVR with low profile vascular plugs. Careful analysis of PVL location on echo before closure greatly facilitates finding the fluoroscopic location of the leak. Decreases in PVL severity are associated with significant clinical improvement.
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Insuficiência da Valva Aórtica/terapia , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateteres Cardíacos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/etiologia , Meios de Contraste , Desenho de Equipamento , Feminino , Fluoroscopia , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/terapia , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Masculino , Desenho de Prótese , Radiografia Intervencionista/métodos , Índice de Gravidade de Doença , Resultado do Tratamento , Disfunção Ventricular Esquerda/etiologia , Disfunção Ventricular Esquerda/terapiaRESUMO
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: The incremental use of transcatheter aortic valve replacement will inexorably lead to structural valve deterioration and the need for both a second and third valvular interventions, raising the question of feasibility. CASE SUMMARY: We present the case of a 76-year-old man that presented with cardiogenic shock refractory to inotropic support. His workup revealed severe bioprosthetic aortic regurgitation 5 years after undergoing transcatheter aortic valve-in-valve implantation. After confirming anatomical suitability with multimodality imaging, he underwent uncomplicated valve-in-valve-in-valve (ViViV) implantation of a 23 mm Edwards S3 Ultra valve with rapid clinical improvement. CONCLUSIONS: Whether in the form of stenosis or severe regurgitation as in our patient, ViViV is feasible. Careful preprocedural planning and confirmation of anatomical suitability with multimodality imaging are key for success and safety.
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Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Masculino , Humanos , Idoso , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Próteses Valvulares Cardíacas/efeitos adversos , Resultado do Tratamento , Substituição da Valva Aórtica Transcateter/efeitos adversos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgiaRESUMO
Background Prevention strategies targeting standard modifiable cardiovascular risk factors (SMuRFs; diabetes, hypertension, smoking, hypercholesterolemia) are critical to improving cardiovascular disease outcomes. However, acute myocardial infarction (AMI) among individuals who lack 1 or more SMuRFs is not uncommon. Moreover, the clinical characteristics and prognosis of SMuRFless individuals are not well characterized. Methods and Results We analyzed AMI hospitalizations from 2000 to 2014 captured by the ARIC (Atherosclerosis Risk in Community) study community surveillance. AMI was classified by physician review using a validated algorithm. Clinical data, medications, and procedures were abstracted from the medical record. Main study outcomes included short- and long-term mortality within 28 days and 1 year of AMI hospitalization. Between 2000 and 2014, a total of 742 (3.6%) of 20 569 patients with AMI were identified with no documented SMuRFs. Patients without SMuRFs were less likely to receive aspirin, nonaspirin antiplatelet therapy, or beta blockers and less often underwent angiography and revascularization. Compared with those with one or more SMuRFs, patients without SMuRFs had significantly higher 28-day (odds ratio, 3.23 [95% CI, 1.78-5.88]) and 1-year (hazard ratio, 2.09 [95% CI, 1.29-3.37]) adjusted mortality. When examined across 5-year intervals from 2000 to 2014, the incidence of 28-day mortality significantly increased for patients without SMuRFs (7% to 15% to 27%), whereas it declined for those with 1 or more SMuRFs (7% to 5% to 5%). Conclusions Individuals without SMuRFs presenting with AMI have an increased risk of all-cause mortality with an overall lower prescription rate for guideline-directed medical therapy. These findings highlight the need for evidence-based pharmacotherapy during hospitalization and the need to discover new markers and mechanisms for early risk identification in this population.
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Diabetes Mellitus , Infarto do Miocárdio , Humanos , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/terapia , Hospitalização , Prognóstico , Aspirina , Fatores de RiscoRESUMO
Aim: To compare the efficacy and safety of P2Y12 inhibitor or aspirin monotherapy for secondary prevention in patients with atherosclerotic cardiovascular disease (ASCVD). Methods and results: Medline, Embase, and Cochrane Central databases were searched to identify randomized trials comparing monotherapy with a P2Y12 inhibitor versus aspirin for secondary prevention in patients with ASCVD (cardiovascular, cerebrovascular, or peripheral artery disease). The primary outcome was major adverse cardiac events (MACE). Secondary outcomes were myocardial infarction (MI), stroke, all-cause mortality, and major bleeding. A random-effects model was used to calculate risk ratios (RR) and the corresponding 95% confidence interval (CI) and heterogeneity among studies was assessed using the Higgins I2 value. A total of 9 eligible trials (5 with clopidogrel and 4 with ticagrelor) with 61 623 patients were included in our analyses. Monotherapy with P2Y12 inhibitors significantly reduced the risk of MACE by 11% (0.89, 95% CI 0.84-0.95, I2 = 0%) and MI by 19% (0.81, 95% CI 0.71-0.92, I2 = 0%) compared with aspirin monotherapy. There was no significant difference in the risk of stroke (0.85, 95% CI 0.73-1.01), or all-cause mortality (1.01, 95% CI 0.92-1.11). There was also no significant difference in the risk of major bleeding with P2Y12 inhibitor monotherapy compared with aspirin (0.94, 95% CI 0.72-1.22, I2 = 42.6%). Results were consistent irrespective of the P2Y12 inhibitor used. Conclusion: P2Y12 inhibitor monotherapy for secondary prevention is associated with a significant reduction in atherothrombotic events compared with aspirin alone without an increased risk of major bleeding.
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BACKGROUND: The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study is a novel proof-of-concept study that evaluated the feasibility of extending the TAILOR-PCI randomized controlled trial (RCT) follow-up period by using a remote digital platform. OBJECTIVE: The aim of this study is to describe patients' onboarding, engagement, and results in a digital study after enrollment in an RCT. METHODS: In this intervention study, previously enrolled TAILOR-PCI patients in the United States and Canada within 24 months of randomization were invited by letter to download the study app. Those who did not respond to the letter were contacted by phone to survey the reasons for nonparticipation. A direct-to-patient digital research platform (the Eureka Research Platform) was used to onboard patients, obtain consent, and administer activities in the digital study. The patients were asked to complete health-related surveys and digitally provide follow-up data. Our primary end points were the consent rate, the duration of participation, and the monthly activity completion rate in the digital study. The hypothesis being tested was formulated before data collection began. RESULTS: After the parent trial was completed, letters were mailed to 907 eligible patients (representing 18.8% [907/4837] of total enrolled in the RCT) within 15.6 (SD 5.2) months of randomization across 24 sites. Among the 907 patients invited, 290 (32%) visited the study website and 110 (12.1%) consented-40.9% (45/110) after the letter, 33.6% (37/110) after the first phone call, and 25.5% (28/110) after the second call. Among the 47.4% (409/862) of patients who responded, 41.8% (171/409) declined to participate because of a lack of time, 31.2% (128/409) declined because of the lack of a smartphone, and 11.5% (47/409) declined because of difficulty understanding what was expected of them in the study. Patients who consented were older (aged 65.3 vs 62.5 years; P=.006) and had a lower prevalence of diabetes (19% vs 30%; P=.02) or tobacco use (6.4% vs 24.8%; P<.001). A greater proportion had bachelor's degrees (47.2% vs 25.7%; P<.001) and were more computer literate (90.5% vs 62.3% of daily internet use; P<.001) than those who did not consent. The average completion rate of the 920 available monthly electronic visits was 64.9% (SD 7.6%); there was no decrease in this rate throughout the study duration. CONCLUSIONS: Extended follow-up after enrollment in an RCT by using a digital study was technically feasible but was limited because of the inability to contact most eligible patients or a lack of time or access to a smartphone. Among the enrolled patients, most completed the required electronic visits. Enhanced recruitment methods, such as the introduction of a digital study at the time of RCT consent, smartphone provision, and robust study support for onboarding, should be explored further. TRIAL REGISTRATION: Clinicaltrails.gov NCT01742117; https://clinicaltrials.gov/ct2/show/NCT01742117.
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BACKGROUND: The use of Impella® to provide hemodynamic support during unprotected left main coronary artery (LMCA) percutaneous coronary intervention (PCI) has been shown to be feasible, but severe AS is a relative contraindication for its use. Balloon aortic valvuloplasty (BAV) may facilitate the use of Impella® in these patients. OBJECTIVE: To assess the feasibility of BAV followed by Impella®-assisted LMCA PCI in patients with severe AS as bridge to TAVR. METHODS: Patients with symptomatic severe AS with LMCA stenosis ≥70% requiring PCI prior to TAVR were included. Outcomes were retrospectively collected. RESULTS: Seven patients underwent BAV followed by Impella®-assisted LMCA PCI. Five patients were male; mean age 86 (75-91; SD ± 5.5). Mean STS score was 6.5% (4.3-13.8; SD ± 3.4). Impella® 2.5 L was used in all cases. The procedure was successful in all patients without peri-procedure complications. At 30-day post-BAV/PCI follow up, all patients had experienced improvement in NYHA class (N = 2 NYHA IV to III, N = 5 NYHA III to II). At such interval, mean EF was 54% (30-77; SD ± 17.7). The post BAV change in AVA [0.8 cm2 (0.4-1.5; SD ± 0.3; P = 0.07)], and AV mean gradient [30.8 mmHg (21-45; SD ± 8.9; P = 0.95)] after the procedure were not statistically significant. All patients underwent TAVR after a median PCI-to-TAVR interval of 62 days (33-339; SD ± 96.7). CONCLUSIONS: BAV followed by Impella®-assisted LMCA PCI appears to be a feasible strategy for intermediate and high surgical risk patients with severe AS undergoing LMCA PCI as bridge to TAVR.
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Estenose da Valva Aórtica , Valvuloplastia com Balão , Intervenção Coronária Percutânea , Substituição da Valva Aórtica Transcateter , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Valvuloplastia com Balão/efeitos adversos , Vasos Coronários , Humanos , Masculino , Intervenção Coronária Percutânea/efeitos adversos , Estudos Retrospectivos , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
Transcatheter edge-to-edge repair has revolutionized the management of mitral regurgitation in the high surgical-risk population. Iatrogenic atrial septal defects (iASDs) are an obligatory consequence of the procedure. The long-term sequelae of persistent iASDs are unknown but are believed to be dependent on their size, directionality of flow, and underlying hemodynamics. We discuss an uncommon scenario of a post-transcatheter edge-to-edge repair iASD that required immediate closure. (Level of Difficulty: Intermediate.).
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As the prevalence of asymptomatic COVID-19 continues to increase, there is an increasing possibility that patients with COVID-19 may presen with ST-segment elevation myocardial infarction (STEMI). With social distancing and restricted access to preventive healthcare and emergency services, the management of acute cardiac emergencies such as myocardial infarction has suffered collateral damage. Thus far, global trends suggest a decrease in STEMI activations with possible worse outcomes due to delayed presentation and management. In this review, we discuss the challenges to STEMI management in the COVID-19 era and provide potential solutions for adherence to evidence-based therapies as the pandemic progresses into the year 2021.
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COVID-19/complicações , Controle de Infecções/organização & administração , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , COVID-19/epidemiologia , COVID-19/prevenção & controle , Humanos , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/etiologiaRESUMO
OBJECTIVES: This study reports 2-year outcomes from the multicenter, prospective, single-arm CLASP study with functional mitral regurgitation (FMR) and degenerative MR (DMR) analysis. BACKGROUND: Transcatheter repair is a favorable option to treat MR. Long-term prognostic impact of the PASCAL transcatheter valve repair system in patients with clinically significant MR remains to be established. METHODS: Patients had clinically significant MR ≥3+ as evaluated by the echocardiographic core laboratory and were deemed candidates for transcatheter repair by the heart team. Assessments were performed by clinical events committee to 1 year (site-reported thereafter) and core laboratory to 2 years. RESULTS: A total of 124 patients (69% FMR, 31% DMR) were enrolled with a mean age of 75 years, 56% were male, 60% were New York Heart Association functional class III to IVa, and 100% had MR ≥3+. At 2 years, Kaplan-Meier estimates showed 80% survival (72% FMR, 94% DMR) and 84% freedom from heart failure (HF) hospitalization (78% FMR, 97% DMR), with 85% reduction in annualized HF hospitalization rate (81% FMR, 98% DMR). MR ≤1+ was achieved in 78% of patients (84% FMR, 71% DMR) and MR ≤2+ was achieved in 97% (95% FMR, 100% DMR) (all p < 0.001). Left ventricular end-diastolic volume decreased by 33 ml (p < 0.001); 93% of patients were in New York Heart Association functional class I to II (p < 0.001). CONCLUSIONS: The PASCAL repair system demonstrated sustained favorable outcomes at 2 years in FMR and DMR patients. Results showed high survival and freedom from HF rehospitalization rates with a significantly reduced annualized HF hospitalization rate. Durable MR reduction was achieved with evidence of left ventricular reverse remodeling and significant improvement in functional status. The CLASP IID/IIF randomized pivotal trial is ongoing.
Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Idoso , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Estudos Prospectivos , Resultado do TratamentoRESUMO
OBJECTIVES: The authors report the CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) expanded experience, 1-year outcomes, and analysis by functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR). BACKGROUND: The 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported. METHODS: Eligible patients had symptomatic MR ≥3+, were receiving optimal medical therapy, and were deemed candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days. Follow-up was continued to 1 year. RESULTS: One hundred nine patients were treated (67% FMR, 33% DMR); the mean age was 75.5 years, and 57% were in New York Heart Association functional class III or IV. At 30 days, there was 1 cardiovascular death (0.9%), MR ≤1+ was achieved in 80% of patients (77% FMR, 86% DMR) and MR ≤2+ in 96% (96% FMR, 97% DMR), 88% of patients were in New York Heart Association functional class I or II, 6-min walk distance had improved by 28 m, and Kansas City Cardiomyopathy Questionnaire score had improved by 16 points (p < 0.001 for all). At 1 year, Kaplan-Meier survival was 92% (89% FMR 96% DMR) with 88% freedom from heart failure hospitalization (80% FMR, 100% DMR), MR was ≤1+ in 82% of patients (79% FMR, 86% DMR) and ≤2+ in 100% of patients, 88% of patients were in New York Heart Association functional class I or II, and Kansas City Cardiomyopathy Questionnaire score had improved by 14 points (p < 0.001 for all). CONCLUSIONS: The PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival, with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at 1 year. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study [CLASP]; NCT03170349).
Assuntos
Procedimentos Cirúrgicos Cardíacos , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Idoso , Humanos , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/cirurgia , Qualidade de Vida , Resultado do TratamentoRESUMO
This review outlines the first trial experience with transcatheter therapy for mitral regurgitation (MR), developed from the EVEREST II MitraClip trial in a trial population comprised predominantly of patients with degenerative mitral regurgitation (DMR). Subsequent experience with MitraClip and several other devices has been mostly in functional MR patients. At the same time, there has been ongoing experience with MitraClip in DMR, and a variety of other devices have been developed for catheter-based treatment of MR. Annuloplasty devices have been indicated for DMR, and the potential for transcatheter annuloplasty to be used, in conjunction with other catheter techniques, such as chordal replacement, as it is in standard mitral repair, is developing. Transcatheter mitral valve replacement will clearly have some role for MR of both functional and degenerative etiologies, when repair is not feasible or fails. This review will discuss the evidence base and future development of these mitral repair and replacement approaches for DMR.
RESUMO
Several options are available to address hemostasis at the end of a cardiac catheterization or percutaneous transfemoral transcatheter aortic valve replacement (TAVR) when conventional options are ineffective. To date, there have been few studies exploring the use of a topical thrombin preparation, as one of its main contraindications is that it cannot be used intravascularly due to risk of embolization. The following case shows safe utilization of Surgiflo hemostatic gel matrix under fluoroscopic guidance against an inflated balloon in order to achieve closure of a fistulous tract from a femoral artery access site during percutaneous TAVR.
Assuntos
Estenose da Valva Aórtica/cirurgia , Cateterismo Periférico/efeitos adversos , Fístula Cutânea , Artéria Femoral , Hemostasia Cirúrgica/métodos , Hemostáticos/administração & dosagem , Hemorragia Pós-Operatória , Substituição da Valva Aórtica Transcateter/efeitos adversos , Fístula Vascular , Idoso , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/fisiopatologia , Cateterismo Periférico/métodos , Angiografia por Tomografia Computadorizada/métodos , Fístula Cutânea/diagnóstico , Fístula Cutânea/etiologia , Fístula Cutânea/terapia , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Humanos , Masculino , Hemorragia Pós-Operatória/diagnóstico , Hemorragia Pós-Operatória/etiologia , Hemorragia Pós-Operatória/terapia , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento , Ultrassonografia Doppler/métodos , Fístula Vascular/diagnóstico , Fístula Vascular/etiologia , Fístula Vascular/terapiaRESUMO
Therapy for mitral regurgitation (MR) has been synonymous with mitral valve surgery. Operative approaches for degenerative MR repair have been associated with excellent results, with durable long term outcomes. Surgery for functional MR has been less successful. MitraClip has shown promise for functional MR, especiall in patinets who are high risk for surgery. The aggregate of nonrandomized global experience with MitraClip in functional MR has been consistent in showing improvements in symptoms and left ventricular remodeling. It remains to be seen how MitraClip therapy will compare with best medical therapy. The COAPT trial will clarify this question.