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BACKGROUND: The right comprehension of ischemic stroke pathogenesis guarantees the best prevention therapy. The term "patent foramen ovale (PFO) related stroke" has been proposed for those events where PFO is supposed to be pathogenetic, but their definition is challenging. A multidisciplinary evaluation in a "Heart & Brain" team (HBteam) including stroke neurologists and interventional cardiologists was therefore highly recommended in the recent guidelines of secondary stroke prevention. OBJECTIVE: We aimed at describing the organization of the HBteam of Careggi-University-Hospital of Florence (Italy), and the results of the first seven years of activity. METHODS: In 2016 Interventional Cardiologists and Stroke Neurologists set up an outpatient clinic for the joined evaluation of patients with PFO and other cardio/neurological conditions. A specific diagnostic-therapeutic hospital plan was produced for PFO patients. Patient empowerment was guaranteed by a hospital explicative webpage, a booklet regarding risks/benefits of PFO closure and a 3D heartmodel to simulate the intervention. Data were collected in a dedicated registry. RESULTS: We evaluated 594 patients for PFO, 40 for left atrial appendage closure and 38 for other conditions. In 20% of PFO-patients, HBteam diagnosis was discordant from that of referring physicians, 14% were stroke misdiagnoses. We advised against closure in 53% of patients. At follow-up 94% of closed patients had no/minimum residual shunt; 3 patients had a cerebral ischemic event. CONCLUSIONS: A dedicated HBteam represents a unique opportunity to share decisions with patients after a thorough empowerment process. The joining of cardioneurological skills allows a better classification of PFO-patients, reducing futile interventions.
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Forame Oval Patente , Acidente Vascular Cerebral , Humanos , Forame Oval Patente/complicações , Forame Oval Patente/cirurgia , Recidiva Local de Neoplasia/complicações , Acidente Vascular Cerebral/diagnóstico , Encéfalo , Prevenção Secundária/métodos , Hospitais , Controle de Qualidade , Resultado do Tratamento , RecidivaRESUMO
BACKGROUND: Patent foramen ovale (PFO) closure is superior to medical therapy alone to prevent stroke recurrence in selected patients. Small cortical infarcts and large right to left shunts seem to identify patients who will benefit most from closure. We aimed to study the correlation between the size of the PFO and the volume of cerebral ischemic lesions in young patients with cryptogenic ischemic stroke. METHODS: PFO dimensions and acute ischemic lesion volume of 20 patients, aged<55 years, were analyzed with transesophageal echocardiography and brain magnetic resonance imaging, respectively. The association between the volume of ischemic lesions with the length of PFO, maximum separation between septum primum and septum secundum, and the combination of the twos was explored. RESULTS: A direct statistically significant correlation was found between cerebral lesion volume and maximum separation of septum primum and septum secundum (p=0.047). Length of PFO showed a non-significant trend towards an inverse correlation with lesion volume (p=0.603). Multiple linear regression analysis showed that cerebral lesion volume was dependent directly on maximum separation and inversely on length of PFO (regression coeff. -0,837; p= 0.057; 2,536, p=0.006, respectively). CONCLUSIONS: These data suggest that even small PFO might be pathogenetic in case of small cerebral infarcts and that large cerebral infarcts might be PFO related if the shunt is large. If confirmed, the combination of detailed characteristics of PFO with the volume of cerebral infarct could be integrated in a new score to select patients who would take real advantage from a percutaneous closure.
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Isquemia Encefálica , Forame Oval Patente , AVC Isquêmico , Acidente Vascular Cerebral , Isquemia Encefálica/complicações , Isquemia Encefálica/diagnóstico por imagem , Ecocardiografia Transesofagiana , Forame Oval Patente/complicações , Forame Oval Patente/diagnóstico por imagem , Humanos , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/diagnóstico por imagemRESUMO
Transcatheter aortic valve implantation (TAVI) has become the leading technique for aortic valve replacement in symptomatic patients with severe aortic stenosis with conventional surgical aortic valve replacement (SAVR) now limited to patients younger than 65-75 years due to a combination of unsuitable anatomies (calcified raphae in bicuspid valves, coexistent aneurysm of the ascending aorta) and concerns on the absence of long-term data on TAVI durability. This incredible rise is linked to technological evolutions combined with increased operator experience, which led to procedural refinements and, accordingly, to better outcomes. The article describes the main and newest technical improvements, allowing an extension of the indications (valve-in-valve procedures, intravascular lithotripsy for severely calcified iliac vessels), and a reduction of complications (stroke, pacemaker implantation, aortic regurgitation).
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Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Humanos , Fatores de Risco , Resultado do TratamentoRESUMO
OBJECTIVES: Aim of this study is to evaluate safety, feasibility, and mid-term outcome of transcatheter aortic valve implantation (TAVI) in cardiogenic shock (CS). BACKGROUND: Balloon aortic valvuloplasty in patients with severe aortic valve stenosis (SAS) complicated by CS is indicated but associated with a grim prognosis. TAVI might be a more reasonable treatment option in this setting but data are scant. METHODS: From March 2008 to February 2019, 51 patients with severe aortic valvulopathy (native SAS or degenerated aortic bioprosthesis) and CS treated by TAVI in 11 European centers were included in this multicenter registry. Demographic, clinical, and procedural data were collected, as well as clinical and echocardiographic follow-up. RESULTS: The mean age of our study population was 75.8 ± 13, 49% were women, and mean Society of Thoracic Surgeons (STS) score was 19 ± 15%. Device success was achieved in 94.1%, with a 5% incidence of moderate/severe paravalvular leak. The 30-day events were mortality 11.8%, stroke 2.0%, vascular complications 5.9%, and acute kidney injury 34%. Valve Academic Research Consortium-2 early safety endpoint was reached in 35.3% of cases. At 1-year of follow-up, the mortality rate was 25.7% and the readmission for congestive heart failure was 8.6%. CONCLUSIONS: TAVI seems to be a therapeutic option for patients with CS and SAS or degenerated aortic bioprosthesis in terms of both safety and efficacy at early and long-term follow-up.
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Estenose da Valva Aórtica/cirurgia , Choque Cardiogênico/etiologia , Substituição da Valva Aórtica Transcateter , Adulto , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Europa (Continente) , Estudos de Viabilidade , Feminino , Próteses Valvulares Cardíacas , Humanos , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente , Complicações Pós-Operatórias/mortalidade , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/mortalidade , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do TratamentoRESUMO
PURPOSE OF REVIEW: In recent years, transcatheter aortic valve replacement (TAVR) and percutaneous mechanical circulatory support (MCS) systems have seen a widespread diffusion. These devices require the insertion of large femoral sheaths in a population of patients often presenting with calcific peripheral artery disease. Small and severely calcified iliac vessels are associated with increased risk of vascular complications or strategy changes such as the use of an alternative subclavian or transapical approach for TAVR or a conversion to surgery. Intravascular lithotripsy (IVL) technology applies mechanical pressure waves to modify vessel calcifications. It has been applied both in coronary and peripheral calcific disease with promising results. The use in vessel preparation before the insertion of large sheaths is an emerging application of this device. RECENT FINDINGS: After case reports and presentations of isolated cases, two multicenter registries collected 42 and 12 patients treated with peripheral IVL before TAVR and MCS insertion. In most cases, the largest balloons were used in the iliac arteries with success achieved directly or using a separate insertion sheath in all cases. Low-pressure dilatation during energy delivery avoided dissections or vessel ruptures with no need of postprocedural stent implantation or emergency surgical repair. IVL can successfully modify the arterial compliance and facilitate transfemoral delivery of TAVR or MCS in patients with calcified iliofemoral vessels, reducing the need for alternative TAVR access routes and allowing to perform high-risk coronary procedures with adequate support.
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Estenose da Valva Aórtica/cirurgia , Calcinose/cirurgia , Circulação Extracorpórea/métodos , Artéria Ilíaca/cirurgia , Litotripsia , Substituição da Valva Aórtica Transcateter/métodos , Circulação Extracorpórea/instrumentação , Artéria Femoral/patologia , Artéria Femoral/cirurgia , Humanos , Artéria Ilíaca/patologiaRESUMO
Background: Percutaneous left atrial appendage closure (LAAC) is an emerging alternative to oral anticoagulation for stroke prevention in atrial fibrillation (AF) in patients with AF, elevated stroke risk and contraindications to long-term anticoagulation treatment. Optimal pre-procedural planning is essential to ensure optimal procedural results. Case summary: We report the case of a 62-year-old man with a history of right cerebellar haematoma referred for LAA closure. We describe the first use of FEops HEARTguide patient-specific computational simulation in the planning of LAAC with the Watchman Flex device (Boston Scientific, Marlborough, MA, USA) in an unusual 'whale tail'-like LAA anatomy. Discussion: Percutaneous left atrial appendage (LAA) closure is feasible in the majority of patients. However, certain LAA anatomies may pose substantial technical challenges. This case shows the crucial role of a pre-procedural assessment based on patient-specific computational simulations for LAA closure in difficult scenarios resulting in a more efficient procedure with the optimal result and good clinical outcomes.
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The recent pandemic with SARS-CoV-2 raises questions worldwide regarding telemedicine for housebound patients, including those with cardiovascular conditions. The need for further investigation, monitoring and therapeutic management are advancing practical issues which had not been identified for consideration prior to the pandemic. Using the marketing assessment, we identified the needs of the patients and evaluated the future steps necessary in the short term to meet them. The research found progress made via telemedicine in monitoring and conducting minor decisions (like up-titrating the doses of different medication regimens) in patients with several cardiovascular diseases (heart failure, atrial fibrillation, high blood pressure), as there is a worldwide trend to develop new telemonitoring biosensors and devices based on implantable delivered transcatheter. The worldwide telemedicine trend encourages a switch from small and hesitating steps to a more consistent assessment of the patients, based on high technology and Interventional Cardiology. Cardiovascular telemedicine, although made a sustainable effort in managing patients' health, has many obstacles to overcome before meeting all their needs. Data security, confidentiality and reimbursement are the top priorities in developing remote Cardiology. The regulatory institutions need to play an integrative role in leading the way for defining the framework of future telemedicine activities. The SARS-CoV-2 outbreak with all its tragedy served to reinforce the message that telemedicine services can be life-saving for cardiovascular patients. Once the Covid-19 era will fade away, telemedicine is likely to remain a complementary service of standard care. There is still room to improve the remote identification and investigation of heart disease, provide an accurate diagnosis and therapeutic regimen, and update regulations and guidelines to the new realities of technological progress in the field.
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BACKGROUND: The presence of severe calcific atherosclerosis at the iliofemoral axis may preclude transcatheter aortic valve implantation (TAVI) by the transfemoral (TF) approach. Intravascular lithotripsy (IVL) is a novel technology that fractures intimal/medial calcium and increases vessel compliance allowing TF TAVI in selected patients with peripheral artery disease (PAD). AIMS: The aim of this study was to report on the safety and efficacy of IVL-assisted TF TAVI in an all-comers population. METHODS: Clinical, imaging and procedural data on all consecutive patients treated by IVL-assisted TF TAVI in six high-volume European centres (2018-2020) were collected in this prospective, real-world, multicentre registry. RESULTS: IVL-assisted TF TAVI was performed in 108 patients, increasing from 2.4% to 6.5% of all TAVI from 2018 to 2020, respectively. The target lesion was most often localised at the common and/or external iliac artery (93.5% of cases; average TL-MLD 4.6±0.9 mm with 318 degrees of calcium arc). Transfemoral aortic valve delivery was successful in 100% of cases; final procedural success in 98.2% (two conversions to cardiac open surgery for annular rupture and valve migration). Complications of the IVL-treated segments consisted of 1 perforation and 3 major dissections requiring stent implantation (2 covered stents and 2 BMS). Access-site-related complications included 3 major bleedings. Three in-hospital deaths were recorded (2.8%, 1 failed surgical conversion after annular rupture, 1 cardiac arrest after initial valvuloplasty, 1 late hyperkalaemia in renal dysfunction). CONCLUSIONS: IVL-assisted TF TAVI proved to be a safe and effective approach, which helps to expand the indications for TF TAVI in patients with severe calcific PAD. However, these patients continue to have a higher-than-average incidence of periprocedural complications.
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Estenose da Valva Aórtica , Litotripsia , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Artéria Femoral/cirurgia , Humanos , Estudos Prospectivos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do TratamentoRESUMO
A longtime aspiration of interventional cardiologists remains to improve the long-term impact of stent permanence in coronaries to restore original vessel patency and physiological endothelium response. Bioresorbable vascular scaffolds were considered revolutionary in coronary devices, but several trials were disappointing; thus, the challenge in this field remains. DESolve is a novolimus-eluting poly-L-lactide-based polymer scaffold that dissolves through a bio-reabsorption mechanism, vanishing completely in 2 years. Its ability to supply the necessary radial strength to support the vessel for the critical early months after delivery is an important feature showing a unique self-correction property, which reduces incomplete stent apposition. Overexpansion has a good, safe margin with DESolve. This review aims to provide an overview of this controversial topic.
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Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Implantes Absorvíveis , Angiografia Coronária , Humanos , Macrolídeos , Desenho de Prótese , Alicerces Teciduais , Resultado do TratamentoRESUMO
THV aortic embolization can be managed percutaneously by snaring the prosthesis in a stable position in ascending aorta. We report two cases of embolized Acurate NEO with extreme mobility of devices in ascending aorta in which a bailout supra-aortic trunk stenting with consistent aortic protrusion were performed stabilizing the devices.
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Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Aorta , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Humanos , Desenho de Prótese , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
A little is known about long-term hemodynamic performance of the transcatheter heart valves (THVs). The aim of the present study was to assess hemodynamic outcome, structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) in patients treated with transcatheter aortic valve replacement (TAVR) five or more years ago. All consecutive patients treated at Bologna and Florence University Hospitals with TAVR between January 2008 and December 2013 were analyzed in a retrospective registry with regards to demographic, procedural and outcome data as well as follow-up data on mortality and echocardiographic characteristics. Standardized definitions were used to define outcomes and durability of the THVs. 400 patients were included in the study, mostly treated with transfemoral TAVR (71.8%), using first generation balloon-expandable (37%) or self-expanding (63%) devices. The 1-year mortality was 21.8% (87 patients) and 5-year mortality was 53.8% (215 patients). Median follow-up was 45.5 months (14.0-68.9) totaling 1516.7 patient/years, with the longest follow-up being 10.25 years. At least one follow-up echocardiogram was available for 320 patients (80%), SVD occurred in 19 of these patients (5.94%): moderate in 17 patients (5.31%) and severe in two patients (0.63%). The hemodynamic presentation was stenosis in most of the cases (12 patients). Late BVF was registered in 10 patients (3.13%) and this was mainly driven by transcatheter paravalvular leak closure (six patients) with subsequent good long-term outcome. Our results confirm that TAVR appears to be a long-lasting treatment strategy with low rates of structural valve degeneration and valve failure.
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Ecocardiografia , Avaliação de Resultados em Cuidados de Saúde/métodos , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , MasculinoRESUMO
Coronary and peripheral calcifications are associated with increased procedural complexity and suboptimal results in both coronary and peripheral percutaneous interventions. Intravascular lithotripsy (IVL) has recently entered the clinical scenario as a new technology for plaque modification, with promising results. We present a case of high risk left main (LM) percutaneous coronary intervention (PCI), in which peripheral Shockwave IVL was used to facilitate the delivery of an Impella CP via a 14 F sheath and coronary IVL was used to prepare a very calcific left main bifurcation lesion before stent deployment.
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Litotripsia , Angioplastia , Doença da Artéria Coronariana/terapia , Humanos , Intervenção Coronária Percutânea , Resultado do Tratamento , Calcificação Vascular/terapiaRESUMO
BACKGROUND: Calcified coronary lesions still represent a challenge for coronary angioplasty, with sub-optimal acute PCI results causing more frequent late stent failure. PURPOSE: The study aimed at the evaluation of the immediate procedural outcome in a real-world consecutive population of a selective use of lithotripsy based on the intravascular imaging assessment with IVUS or OCT. METHODS AND RESULTS: Thirty-one calcified stenoses (28 patients) out of a total of 455 lesions (370 patients) treated between November 2018 and May 2019 received IVL under intravascular imaging guidance. The majority of the IVL lesions had angiographically severe calcifications and were selected after intravascular imaging. A smaller group was identified by poor expansion after high-pressure balloon dilatation, in one case despite preliminary small burr Rotablation. After IVL, when OCT was performed calcium fractures were observed in 71% of cases. After OCT/IVUS guided stent optimization a satisfactory lumen enlargement (minimal stent area 7.09⯱â¯2.77â¯mm2) was observed with good stent expansion (residual area stenosis<20% in 29 lesions, 93.5%) Peri-procedural complications were limited to one dissection at the distal edge requiring an additional stent and 3 peri-procedural myocardial infarctions. There were no periprocedural coronary perforations or pericardial effusions, and no in-hospital or 30â¯days stent thrombosis. When patients were divided into two subgroups according to a calcium arc ≤180° (Group A: 10 lesions, calcium arc 140⯱â¯24°; Group B: 21 lesions, calcium arc 289⯱â¯53°), at OCT Group B presented also a higher number of calcium fractures post IVL than group A (group A: 38% vs group B: 92%, pâ¯=â¯0.03). The in-stent minimum lumen diameter (MSD), the in stent minimal lumen area (MSA) and the acute gain, however, were similar between the two groups (acute gain group A: 1.22⯱â¯0.29â¯mm; group B: 1.31⯱â¯0.52â¯mm, pâ¯=â¯0.63). CONCLUSIONS: A standardized algorithm applying intravascular imaging guidance of IVL facilitated second generation DES expansion delivers excellent immediate lumen expansion and patient outcome, both in concentric and eccentric calcifications.
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Litotripsia , Angiografia Coronária , Doença da Artéria Coronariana/terapia , Humanos , Intervenção Coronária Percutânea , Stents , Resultado do Tratamento , Ultrassonografia de IntervençãoRESUMO
BACKGROUND: In spite of the increased use of Trans-catheter Aortic Valve Implantation (TAVI) due to the better patient selection, well-trained operators and improved technology, the choice of the best anesthesia regimen remains an open question. In particular, it remains to be clarified whether deep sedation (DS) in spontaneous breathing or femoral local anesthesia (LA) is best. OBJECTIVE: This study compared the hemodynamic variations determined by deep sedation (DS) with spontaneous breathing and local femoral anesthesia (LA) in 2 groups of patients submitted to TAVI with two different kinds of anesthesia, using a beat-by-beat pulse contour method (MostCare®-UP). METHODS: 82 patients with severe aortic stenosis and similar baseline characteristics and indications underwent trans-femoral TAVI: 50 with LA and 32 with DS. All patients were submitted to minimally invasive hemodynamic monitoring. The following parameters were measured: pressure indexes: systolic, diastolic, mean (SysP, DiaP, MAP) and dicrotic (DicP) pressures; flow indexes: cardiac output (CO), stroke volume (SV); ventriculo-arterial coupling indexes (VAC): peripheral arterial elastance (EaP), systemic vascular resistance (SVR); cardiovascular system performance: cardiac cycle efficiency (CCE), dP/dtmax_rad. RESULTS: The TAVI procedure was successful in 89% of patients (VARC-2 criteria) with no difference between the 2 groups. Anesthesia induction determined a higher decrease of pressures in DS than in LA (P<0.01) with no differences in CO. The VAC parameters (EaP, SVR) decreased (P<0.01) in DS with an improvement in CCE (P<0.001); these parameters did not change in LA. The post-TAVI flow and VAC parameters, especially Ea, increased (P<0.05) more significantly in the LA group than in the DS group (P<0.001). Using logistic regression, the occurrence of the post-TAVI aortic regurgitation was correctly associated with the pressure gradient MAP-DicP in 63% of the study population (P=0.033). This association was more effectively detected in the LA group (78%, P=0.011) with a ROC AUC=0.779, than the DS group. CONCLUSION: The use of the pulse contour method to track the fast-hemodynamic changes during the TAVI procedure proved suitable for the aim. As expected, LA and DS induced different pre-TAVI hemodynamic conditions, which influenced the post-TAVI hemodynamic changes. The hemodynamic conditions induced by LA, enabled the occurrence of post-TAVI aortic regurgitation to be detected more effectively.
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Introduction: Patients with atrial fibrillation (AF) can experience ischemic stroke despite adequate anticoagulant therapy. The secondary prevention strategy of these so-called "resistant strokes" is empirical. Since about 90% of patients with ischemic stroke due to atrial fibrillation have thrombus in left atrial appendage (LAA) we sought to explore the possibility that resistant stroke could have a LAA morphology resistant to anticoagulants. Case Report: A 77 years old man affected by AF experienced two cardioembolic ischemic stroke while on anticoagulants. The study of LAA showed a windsock-like morphology in the proximal part while distally the LAA presented a cauliflower morphology with a large amount of pectinate muscles and blood stagnation. The precise characteristics of LAA were properly understood integrating images obtained by cardiac CT, transesophageal echocardiography, and selective angiography. A high risky LAA for thrombus formation was diagnosed and its occlusion (LAAO) as an add-on therapy to anticoagulants was proposed and performed. Six month follow-up was uneventfully. Conclusion: The systematic study of LAA in patients with resistant-stroke could help to identify LAA malignant morphology. The efficacy on stroke recurrence of the combined therapy (anticoagulants plus LAAO) is worthy to be tested in randomized trials.
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Transcatheter aortic valve implantation (TAVI) has been a revolution in the treatment of severe aortic stenosis evolving to a high procedural success rate and low rate of complications. Embolization of the percutaneous device is a rare but potentially life-threatening complication. The spectrum of clinical manifestations ranges between incidental finding on cardiac imaging to cardiogenic shock or cardiac arrest. Data about predictors and management of transcatheter heart valve embolization are scarce and mostly anecdotical. Management strategies are related to the type, the size, the location of the embolized device, the timing of diagnosis, and the clinical presentation of the patient. According to recent data from TRAVEL registry, device embolization and migration occur in approximately 1% of the patients and is responsible for increased morbidity and mortality. However, in a considerable proportion of cases it could have been prevented, hence structural interventionalists should plan the procedures carefully and know thoroughly the risk factors for device embolization. Increased awareness of predisposing factors, preventive measures, and appropriate bail-out options and techniques are strongly advisable. This paper is a review of the incidence, and outcomes of percutaneous prosthesis embolization during TAVI. It also suggests an integrated algorithmic approach for the management of device embolization incorporating both percutaneous and surgical techniques.
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Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Cateterismo Cardíaco , Humanos , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
INTRODUCTION AND OBJECTIVES: Despite the efficacy of oral anticoagulant (OAC) therapy, some patients continue to have a high residual risk and develop a stroke on OAC therapy (resistant stroke [RS]), and there is a lack of evidence on the management of these patients. The aim of this study was to analyze the safety and efficacy of left atrial appendage occlusion (LAAO) as secondary prevention in patients with nonvalvular atrial fibrillation who have experienced a stroke/transient ischemic attack despite OAC treatment. METHODS: We analyzed data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients with nonvalvular atrial fibrillation undergoing LAAO. Patientes with previous stroke on OAC therapy as indication for LAAO were identified and compared with patients with other indications. RESULTS: A total of 115 patients (11%) with RS were identified. The CHA2DS2-VASc and the HAS-BLED score were significantly higher in the RS group (respectively 5.5±1.5 vs 4.3±1.6; P <.001; 3.9±1.3 vs 3.1±1.2; P <.001). No significant differences were observed in periprocedural major safety events (7.8 vs 4.5%; P=.1). With a mean clinical follow-up of 16.2±12.2 months, the observed annual stroke/transient ischemic attack rate for the RS group was 2.6% (65% risk reduction) and the observed annual major bleeding rate was 0% (100% risk reduction). CONCLUSIONS: Patients with RS undergoing LAAO showed similar safety outcomes to patients without RS, with a significant reduction in stroke/transient ischemic attack and major bleeding events during follow-up. Adequately powered controlled trials are needed to further investigate the use of LAAO in RS patients.
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Anticoagulantes/administração & dosagem , Fibrilação Atrial/terapia , Sistema de Registros , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Administração Oral , Idoso , Fibrilação Atrial/complicações , Cateterismo Cardíaco/métodos , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Humanos , Incidência , Masculino , Estudos Retrospectivos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
Degenerative mitral regurgitation in elderly patients and functional mitral regurgitation secondary to severe left ventricular dysfunction are not easy options for conventional surgery. Recently, a new percutaneous approach has been proposed with the MitraClip®, based on the Alfieri edge-to-edge repair technique. The aim of the study is to report, compare and discuss the results of two multicenter randomized trials: MITRA.FR and COAPT in light of the current practice. In both trials patients with functional mitral regurgitation grade 3/4+ or 4/4+ were randomly assigned, in 1:1 ratio, to undergo percutaneous repair and optimal medical therapy or optimal medical therapy alone. Other baseline characteristics reflecting severity of mitral regurgitation and of left ventricular impairment were statistically different, such as the effective regurgitant orifice area (0.31 cm2 in MITRA.FR vs 0.41 cm2 in COAPT) and the indexed LVEDV (135 ± 37 ml/m2 in MITRA.FR vs 101 ± 34 ml/m2 in COAPT). A 24 months follow-up and a 12 months follow-up have been completed, respectively, in COAPT and MITRA.FR. Out of the 307 patients enrolled in the MITRA.FR, 152 were randomized to percutaneous treatment but only in 138 (95.8%) the MitraClip® was actually implanted. At the end of the follow-up a residual mitral regurgitation of at least grade 3+ has been observed in 17% of the patients. A composite of death from any cause or unplanned hospitalizations for heart failure at 12 months respectively occurred in 83 patients (54.6%) treated percutaneously and 78 patients (51.3%) treated with medical therapy only. A total of 614 patients have been enrolled in the COAPT and 293 underwent transcatheter treatment. A successful implantation of the MitraClip® was achieved in 287 patients (98.0%). Hospitalization for heart failure at 24 months occurred in 160 patients in the device group and in 283 in the control group, with an annualized ratio of 35.8% and 67.9%, respectively (p > 0.001). The conflicting results of the two trials may have many explanations, but probably the main cause is the most stringent inclusion criteria in COAPT. The effective reduction of mitral regurgitation and improvement in exercise capacity already observed in registries including more than 70,000 patients was confirmed in a randomized trial with improvement observed in hard end-points. This has already led to an extension of FDA approval to functional regurgitation and a more liberal use across the world.