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Study objective: Assessing if Transcatheter Edge to Edge Repair (TEER) with Mitraclip™ in patients with moderate to severe mitral regurgitation (MR) and cardiogenic shock (CS) improves outcomes compared to medical management alone. Design: A single-center, retrospective study was performed in an urban tertiary referral center. Setting: Rush University Medical Center, United States. Participants: Adult patients presenting with CS and moderate to severe MR between 2012 and 2021 were included. Interventions: Undergoing Mitral TEER with Mitraclip versus medical management alone. Main outcome measures: Major adverse cardiovascular events (MACE) defined as cardiovascular death, heart failure admission, stroke, and myocardial infarction assessed at 30 days, 6 months, and 1 year. The secondary outcome was a change in New York Heart Association (NYHA) classification at 30 days and 6 months. Results: There were 28 patients included in the medical management and 33 in the mitral valve TEER groups. There was a decreased MACE in the intervention group at 30 days (24.2 % vs. 46.4 %, p ≤0.001) and 6 months (27 % vs. 75 %, p = 0.002), though not at 1 year (29.4 % vs. 41.7 %, p = 0.42). At 30 days, more patients in the mitral valve TEER group improved to NYHA classes I/II compared to medical management alone (10 [35.7 %] vs. 16 [50 %], p = 0.043). There were no differences in NYHA classes I/II at 6 months (7 [43.7 %] vs. 13 [54.2 %], p = 0.63). Conclusion: Mitral valve TEER using the Mitraclip™ system improves mid-term cardiovascular compared to medical management alone in patients with CS but does not improve mortality.
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PURPOSE OF REVIEW: Patent foramen ovale (PFO) has been previously linked to left circulation thromboembolism and stroke. This review article aims to discuss the latest evidence, updated societal guidelines, diagnostic algorithms and novel therapeutic devices for PFO closure. RECENT FINDINGS: PFO closure for cryptogenic stroke and systemic embolization is supported by a large body of evidence and has a strong societal recommendation. Limited data are available for platypnea-orthodeoxia syndrome, although closure appears to be beneficial. Current data do not support routine closure for migraines and decompression Illness. Development of heart-brain teams can improve identification of patients most likely to benefit from closure, utilizing a combination of imaging test and risk score algorithms. Multiple novel devices aiming at reducing complications and improving the long-term impact of current available devices are being evaluated. PFO closure has significantly progressed over the last years, with new data supporting its superiority in reducing risk of recurrent embolic stroke in patients with PFO-related stroke. Additional clinical data are required to provide further refinements on patient selection and guidance on treatment of specific subgroups.
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Foramen Oval Permeable , Dispositivo Oclusor Septal , Foramen Oval Permeable/complicaciones , Foramen Oval Permeable/cirugía , Foramen Oval Permeable/terapia , Humanos , Cateterismo Cardíaco/métodos , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/etiología , Resultado del Tratamiento , Guías de Práctica Clínica como AsuntoRESUMEN
BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death worldwide, but prevalence estimates in former professional athletes are limited. OBJECTIVES: HUDDLE (Heart Health: Understanding and Diagnosing Disease by Leveraging Echocardiograms) aimed to raise awareness and estimate the prevalence of CVD and associated risk factors among members of the National Football League (NFL) Alumni Association and their families through education and screening events. METHODS: HUDDLE was a multicity, cross-sectional study of NFL alumni and family members aged 50 years and older. Subjects reported their health history and participated in CVD education and screening (blood pressure, electrocardiogram, and transthoracic echocardiogram [TTE] assessments). Phone follow-up by investigators occurred 30 days postscreening to review results and recommendations. This analysis focuses on former NFL athletes. RESULTS: Of 498 participants screened, 57.2% (N = 285) were former NFL players, the majority of whom were African American (67.6%). The prevalence of hypertension among NFL alumni was estimated to be 89.8%, though only 37.5% reported a history of hypertension. Of 285 evaluable participants, 61.8% had structural cardiac abnormalities by TTE. Multivariable analysis showed that hypertension was a significant predictor of clinically relevant structural abnormalities on TTE. CONCLUSIONS: HUDDLE identified a large discrepancy between participant self-awareness and actual prevalence of CVD and risk factors, highlighting a significant opportunity for population health interventions. Structural cardiac abnormalities were observed in most participants and were independently predicted by hypertension, affirming the role of TTE for CVD screening in this population aged older than 50 years. (Heart Health: Understanding and Diagnosing Disease by Leveraging Echocardiograms [HUDDLE]; NCT05009589).
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Enfermedades Cardiovasculares , Fútbol Americano , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Enfermedades Cardiovasculares/epidemiología , Estudios Transversales , Factores de Riesgo , Estados Unidos/epidemiología , Anciano , Femenino , Atletas/estadística & datos numéricos , EcocardiografíaRESUMEN
Severe aortic stenosis is a common valvular heart disease associated with significant mortality and morbidity. Transcatheter aortic valve replacement (TAVR) is an effective treatment for this condition. Less data is available regarding functional and quality-of-life outcomes in patients with severe, low-gradient aortic stenosis following TAVR. This single-center, retrospective study compared changes in New York Heart Association (NYHA) class and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores at 30 days and 1 year in patients with 3 variants of severe, low-gradient aortic stenosis following TAVR. Secondary outcomes included 1-year major adverse cardiovascular event. A total of 170 patients were included. All 3 low-gradient variants had significant improvement in NYHA class and KCCQ overall scores at 30 days and 1 year. There were no significant differences in KCCQ overall scores between the 3 groups and no significant differences in secondary outcomes. Patients with low-gradient aortic stenosis experienced significant improvements in functional and quality-of-life outcomes following TAVR.
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Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Calidad de Vida , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estado de Salud , Estudios Retrospectivos , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Válvula Aórtica/cirugía , Factores de Riesgo , Índice de Severidad de la EnfermedadRESUMEN
Background Results from multiple clinical trials support patent foramen ovale closure after cryptogenic stroke in select patients, but it remains unclear how new data and updated professional society guidelines have impacted clinical practice. Here, we aimed to compare how stroke neurologists and interventional cardiologists approach patients with cryptogenic stroke with patent foramen ovale and how critical anatomic and clinical factors influence decision making. Methods and Results An electronic survey was administered to 1556 vascular neurologists and 1057 interventional cardiologists throughout the United States. The survey addressed factors such as patient age, preclosure workup, and postclosure antithrombotics. Clinical vignettes highlighted critical variables and used a 5-point Likert scale to assess the providers' level of support for closure. There were 491 survey responses received from 301 (of 1556) vascular neurologists and 190 (of 1057) interventional cardiologists, with an overall response rate of 19%. Vascular neurologists were more likely to recommend against closure on the basis of older age (P<0.001). Interventional cardiologists are more supportive of closure across a range of clinical vignettes, including a very carefully selected patient with cryptogenic stroke (P<0.001), a patient with a high-risk alternative stroke cause (P<0.001), and a range of cases highlighting clinical variables where data are lacking. The majority of interventionalists (88%) seek neurology consultation before pursuing patent foramen ovale closure. Conclusions lnterventional cardiologists are more likely than vascular neurologists to support patent foramen ovale closure across a range of situations. This emphasizes the importance of collaboration and shared decision making, but also reveals an opportunity for professional society educational outreach.
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Cardiólogos , Foramen Oval Permeable , Accidente Cerebrovascular Isquémico , Dispositivo Oclusor Septal , Accidente Cerebrovascular , Humanos , Foramen Oval Permeable/complicaciones , Foramen Oval Permeable/terapia , Neurólogos , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular Isquémico/complicaciones , Prevención Secundaria/métodos , Resultado del Tratamiento , Dispositivo Oclusor Septal/efectos adversosRESUMEN
Exclusion of the left atrial appendage to reduce thromboembolic risk related to atrial fibrillation was first performed surgically in 1949. Over the past 2 decades, the field of transcatheter endovascular left atrial appendage closure (LAAC) has rapidly expanded, with a myriad of devices approved or in clinical development. The number of LAAC procedures performed in the United States and worldwide has increased exponentially since the Food and Drug Administration approval of the WATCHMAN (Boston Scientific) device in 2015. The Society for Cardiovascular Angiography & Interventions (SCAI) has previously published statements in 2015 and 2016 providing societal overview of the technology and institutional and operator requirements for LAAC. Since then, results from several important clinical trials and registries have been published, technical expertise and clinical practice have matured over time, and the device and imaging technologies have evolved. Therefore, SCAI prioritized the development of an updated consensus statement to provide recommendations on contemporary, evidence-based best practices for transcatheter LAAC focusing on endovascular devices.
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Apéndice Atrial , Fibrilación Atrial , Accidente Cerebrovascular , Humanos , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Apéndice Atrial/diagnóstico por imagen , Resultado del Tratamiento , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/terapia , AngiografíaRESUMEN
Exclusion of the left atrial appendage to reduce thromboembolic risk related to atrial fibrillation was first performed surgically in 1949. Over the past 2 decades, the field of transcatheter endovascular left atrial appendage closure (LAAC) has rapidly expanded, with a myriad of devices approved or in clinical development. The number of LAAC procedures performed in the United States and worldwide has increased exponentially since the Food and Drug Administration approval of the WATCHMAN (Boston Scientific) device in 2015. The Society for Cardiovascular Angiography & Interventions (SCAI) has previously published statements in 2015 and 2016 providing societal overview of the technology and institutional and operator requirements for LAAC. Since then, results from several important clinical trials and registries have been published, technical expertise and clinical practice have matured over time, and the device and imaging technologies have evolved. Therefore, SCAI prioritized the development of an updated consensus statement to provide recommendations on contemporary, evidence-based best practices for transcatheter LAAC focusing on endovascular devices.
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Apéndice Atrial , Fibrilación Atrial , Accidente Cerebrovascular , Tromboembolia , Humanos , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Apéndice Atrial/diagnóstico por imagen , Apéndice Atrial/cirugía , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Angiografía , Resultado del TratamientoRESUMEN
Current estimates suggest that a patent foramen ovale (PFO) may exist in up to 25% of the general population and is a potential risk factor for embolic, ischemic stroke. PFO closure complications include bleeding, need for procedure-related surgical intervention, pulmonary emboli, device malpositioning, new onset atrial arrhythmias, and transient atrioventricular block. Rates of PFO closure complications at a national level in the Unites States remain unknown. To address this, we performed a contemporary nationwide study using the 2016 and 2017 Nationwide Readmissions Database (NRD) to identify patterns of readmissions after percutaneous PFO closure. In conclusion, our study showed that following PFO closure, the most common complications were atrial fibrillation/atrial flutter followed by acute heart failure syndrome, supraventricular tachycardia and acute myocardial infarction.
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Fibrilación Atrial , Aleteo Atrial , Foramen Oval Permeable , Dispositivo Oclusor Septal , Accidente Cerebrovascular , Humanos , Estados Unidos/epidemiología , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/complicaciones , Cateterismo Cardíaco/efectos adversos , Foramen Oval Permeable/diagnóstico , Foramen Oval Permeable/epidemiología , Foramen Oval Permeable/cirugía , Fibrilación Atrial/epidemiología , Factores de Riesgo , Resultado del Tratamiento , Dispositivo Oclusor Septal/efectos adversos , RecurrenciaRESUMEN
The patent foramen ovale (PFO) is a flap or tunnel-like communication in the atrial septum present in 20% to 34% of the adult population. In most cases, it is a benign finding and poses no health risk. However, some PFOs may provide a conduit for bloodborne materials, such as thrombi, vasoactive substances, or air to pass into the systemic circulation causing a paradoxical embolus. PFOs have been linked with several clinical disease states including cryptogenic stroke, migraine headache, platypnea-orthodeoxia, and decompression illness. Percutaneous PFO closure provides a practical solution to the problem of PFO in carefully selected populations. Recent randomized control trials have demonstrated that PFO closure in patients with cryptogenic stroke is associated with reduced rates of recurrent stroke compared with medical therapy. This translated into a dramatic increase in the number of PFO closure procedures worldwide, primarily for the indication of cryptogenic stroke, with high procedural success and low complication rates. However, there are no randomized clinical trials available to support PFO closure in other clinical conditions. This article reviews potential indications, existing data, and management approaches for PFO closure in disorders other than cryptogenic stroke.
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Exclusion of the left atrial appendage to reduce thromboembolic risk related to atrial fibrillation was first performed surgically in 1949. Over the past 2 decades, the field of transcatheter endovascular left atrial appendage closure (LAAC) has rapidly expanded, with a myriad of devices approved or in clinical development. The number of LAAC procedures performed in the United States and worldwide has increased exponentially since the Food and Drug Administration approval of the WATCHMAN (Boston Scientific) device in 2015. The Society for Cardiovascular Angiography & Interventions (SCAI) has previously published statements in 2015 and 2016 providing societal overview of the technology and institutional and operator requirements for LAAC. Since then, results from several important clinical trials and registries have been published, technical expertise and clinical practice have matured over time, and the device and imaging technologies have evolved. Therefore, SCAI prioritized the development of an updated consensus statement to provide recommendations on contemporary, evidence-based best practices for transcatheter LAAC focusing on endovascular devices.
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Background Evidence from randomized trials and updated professional society guidelines supports patent foramen ovale (PFO) closure after cryptogenic stroke in select patients. It is unclear how this has been integrated into real-world practice, so we aimed to compare practice patterns between cardiologists and neurologists. Methods and Results In March of 2021, a survey of cardiologists and neurologists who work or previously trained at the University of Pennsylvania Health System assessed practice preferences with respect to PFO closure after stroke. Clinical vignettes isolated specific variables of interest and used a 5-point Likert scale to assess the level of support for PFO closure. Stroke neurologists and interventional cardiologists were compared by Wilcoxon-Mann-Whitney tests. Secondarily, Kruskal-Wallis tests compared stroke neurologists, general neurologists, interventional cardiologists, and general cardiologists. We received 106 responses from 182 survey recipients (31/31 stroke neurologists, 38/46 interventional cardiologists, 20/30 general neurologists, and 17/77 general cardiologists). A similar proportion of stroke neurologists and interventional cardiologists favored PFO closure in a young patient with cryptogenic stroke, 88% and 87%, respectively (P=0.54). Interventionalists were more likely than stroke neurologists to support closure in the context of an alternative high-risk stroke mechanism, 14% and 0%, respectively (P=0.003). Stroke neurologists were more likely to oppose closure on the basis of older age (P=0.01). Conclusions There are key differences between how neurologists and cardiologists approach PFO closure after stroke, particularly when interpreting the stroke etiology and when considering closure beyond the scope of prior trials; this underscores the importance of collaboration between cardiologists and neurologists.
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Foramen Oval Permeable , Accidente Cerebrovascular Isquémico , Cateterismo Cardíaco , Cardiólogos , Cardiología , Foramen Oval Permeable/complicaciones , Foramen Oval Permeable/terapia , Humanos , Accidente Cerebrovascular Isquémico/etiología , Neurólogos , Neurología , Recurrencia , Prevención Secundaria , Dispositivo Oclusor Septal , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/terapia , Resultado del TratamientoRESUMEN
OBJECTIVES: The aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States. BACKGROUND: The National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of "real-world" patients have not been previously reported. METHODS: Patients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates. RESULTS: The study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA2DS2-VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier-estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure. CONCLUSIONS: This study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy.
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Apéndice Atrial , Fibrilación Atrial , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Anciano , Anciano de 80 o más Años , Apéndice Atrial/diagnóstico por imagen , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Fibrilación Atrial/terapia , Hemorragia , Humanos , Medicare , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
Background: Patent foramen ovale (PFO) is a vestigial congenital cardiovascular structure present in around 25% of adults. In most cases, PFO is entirely benign and requires no treatment. However, it may cause serious complications under certain circumstances. Objective: These evidence-based guidelines from the Society for Cardiovascular Angiography and Interventions (SCAI) aim to support patients, clinicians, and other stakeholders in decisions about management of PFO. Methods: SCAI convened a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The Evidence Foundation, a registered 501(c)(3) nonprofit organization, provided methodological support for the guideline-development process. Following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, the guideline panel formulated and prioritized clinical questions in population, intervention, comparison, outcome (PICO) format. A separate technical review team of clinical and methodological experts conducted systematic reviews of the evidence, synthesized data, and graded the certainty of the evidence across outcomes. The guideline panel then reconvened to formulate recommendations and supporting remarks informed by the results of the technical review and additional contextual factors described in the GRADE evidence-to-decision framework. Results: The panel agreed on 13 recommendations to address variations on 5 clinical scenarios. Conclusions: Key recommendations address patient selection for PFO closure in the prevention of recurrent PFO-associated stroke, including populations not commonly included in randomized studies, and scenarios where the PFO closure might serve a role in the prevention of other outcomes such as migraine headaches and decompression illness. The panel has also identified future research priorities to advance the field.
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The majority of embolic strokes in patients with nonvalvular atrial fibrillation are caused by thrombi in the left atrial appendage. It is projected that strokes related to atrial fibrillation will markedly increase in the future unless effective mitigation strategies are implemented. Systemic anticoagulation has been known to be highly effective in reducing stroke risk in patients with atrial fibrillation. However, bleeding complications and nonadherence are barriers to effective anticoagulation therapy. Surgical and percutaneous left atrial appendage occlusion devices are nonpharmacologic strategies to mitigate the challenges of drug therapy. We present a contemporary review of left atrial appendage occlusion for stroke prevention in nonvalvular atrial fibrillation. A thorough review of the history of surgical and percutaneous left atrial appendage occlusion devices, recent trials, and US Food and Drug Administration milestones of current left atrial appendage occlusion devices are discussed.
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Apéndice Atrial , Fibrilación Atrial , Accidente Cerebrovascular , Anticoagulantes/uso terapéutico , Apéndice Atrial/cirugía , Fibrilación Atrial/complicaciones , Fibrilación Atrial/terapia , Hemorragia , Humanos , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & controlRESUMEN
BACKGROUND: Vein sclerosing therapy for varicose veins remains an extremely popular procedure. Cerebrovascular accidents can be a serious complication. A patent foramen ovale (PFO) can act as a conduit to the arterial circulation, which could explain the adverse neurologic consequence of this procedure. This case provides pathologic evidence of this concept. CASE SUMMARY: A 66-year-old female presented with syncope after undergoing varicose vein sclerotherapy. A computed tomography angiography of the head and neck in the emergency room revealed an occluded right distal M1 middle cerebral artery. Clot retrieval was performed with final pathology revealing amorphous material consistent with an exogenous agent, polidocanol foam, which was used for the patient's vein sclerotherapy. A transthoracic echocardiogram and transoesophageal echocardiogram showed a PFO, which was ultimately closed percutaneously. DISCUSSION: In a quarter of the population, lack of closure of the intrauterine interatrial shunt leads to the existence of a PFO. This direct communication between the atria provides an anatomical conduit for paradoxical emboli and eventually infarction of affected tissues. While a paradoxical embolism is an uncommon cause of acute arterial occlusion, it can have catastrophic sequelae. Historically, the presence of an arterial thrombus from the venous circulation has been difficult to establish unless the thrombus is visualized in transit through a PFO. Complications from vein sclerotherapy have been reported in the literature and include transient ischaemic attacks and strokes, however, this is the first case to provide pathological proof of a paradoxical embolism, which ultimately resulted in percutaneous closure of the PFO.
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BACKGROUND: Acute right ventricular (RV) failure is challenging to treat and mechanical circulatory support devices are limited. The TandemHeart ProtekDuo (THPD; TandemLife) is a novel percutaneous RV assist device that can provide 4.0 liters per minute of blood flow through venovenous extracorporeal life support. It allows venous drainage from the right atrium and reinfusion of blood into the main pulmonary artery via internal jugular vein access. We aim to provide real-world insight into disease characteristics resulting in the use of THPD for mechanical support and enhance knowledge of best practice regarding clinical management weaning and removal/exit strategies. METHODS: We retrospectively collected data of consecutive patients who received a THPD device at our center for acute RV failure between August 2015 and February 2018. RESULTS: Eleven patients were diagnosed with acute RV failure and required placement of THPD. The hospital length of stay ranged from 12 to 223 days. The average length of support ranged from 11 to 154 days. We observed complications such as stroke (18.2%), sepsis (63.6%), massive gastrointestinal bleed (45.5%), and heparin-induced thrombocytopenia (54.5%). These patients received on average 85 units of blood products. Survival was 82% at 30 days and 72% at 180 days. Six of the patients were successfully weaned from the THPD devices and 1 patient required venovenous extracorporeal life support. CONCLUSIONS: This real-world experience, despite high morbidity, continues to suggest benefits of THPD for patients with severe acute RV failure.