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1.
Curr Opin Cardiol ; 39(2): 79-85, 2024 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-38116841

RESUMEN

PURPOSE OF REVIEW: Tricuspid transcatheter edge-to-edge repair (T-TEER) has emerged as a well tolerated and effective therapeutic option for many patients with symptomatic severe tricuspid regurgitation at prohibitive surgical risk. However, there remain several important limitations to clip-based technology in the context of other rapidly emerging percutaneous treatment options for tricuspid regurgitation. RECENT FINDINGS: Tricuspid lesions pose unique challenges to treatment with the current toolbox of transcatheter clip-based technologies. This review will explore key issues related to patient factors, anatomical factors, and imaging factors that may render lesions to be unsuitable for treatment with T-TEER. SUMMARY: Selection for T-TEER must include a detailed clinical evaluation in the context of a 'heart team' approach involving multiple subspecialists, with screening for patient/lesion characteristics that make T-TEER suboptimal with current clip-based technologies. Future directions for research include patient-specific 3D modeling techniques, leaflet grasping techniques, clip deployment strategies, and personalized device sizing to increase the spectrum of lesions that may be treated with T-TEER within the context of other emerging transcatheter treatment options.


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Humanos , Insuficiencia de la Válvula Tricúspide/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Resultado del Tratamiento , Cateterismo Cardíaco/métodos , Predicción
2.
Catheter Cardiovasc Interv ; 103(1): 202-208, 2024 01.
Artículo en Inglés | MEDLINE | ID: mdl-38009641

RESUMEN

BACKGROUND: Conduction disturbances and the need for permanent pacemaker (PPM) implantation remains a common complication for transcatheter aortic valve replacement (TAVR), particularly when self-expanding (SE) valves are used. AIMS: We compared in-hospital and 30-day rates of new PPM implantation between patients undergoing TAVR with SE valves using the conventional three-cusp coplanar implantation technique and the cusp-overlap technique. METHODS: We retrospectively compared patients without a pre-existing PPM who underwent a TAVR procedure with SE Evolut R or PRO valves using the cusp-overlap technique from July 2018 to September 2020 (n = 519) to patients who underwent TAVR using standard three-cusp technique from April 2016 to March 2017 (n = 128) in two high volume Canadian centers. RESULTS: There was no significant difference in baseline RBBB between the groups (10.4% vs. 13.2; p = 0.35). The rate of in-hospital new complete heart block (9.4% vs. 23.4%; p ≤ 0.001) and PPM implantation (8% vs. 21%; p ≤ 0.001) were significantly reduced when using the cusp-overlap technique. The incidence of new LBBB (30.4% vs. 29%; p = 0.73) was similar. At 30 days, the rates of new complete heart block (11% vs. 23%; p ≤ 0.001) and PPM implantation (10% vs. 21%, p ≤ 0.001) remained significantly lower in the cusp-overlap group, while the rate of new LBBB (35% vs. 30%; p = 0.73) was similar. CONCLUSION: Cusp-overlap approach offers several potential technical advantages compared to standard three-cusp view, and may result in lower PPM rates in TAVR with SE Evolut valve.


Asunto(s)
Estenosis de la Válvula Aórtica , Bloqueo Atrioventricular , Prótesis Valvulares Cardíacas , Marcapaso Artificial , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento , Diseño de Prótesis , Canadá , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía
3.
Catheter Cardiovasc Interv ; 104(2): 356-364, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38699843

RESUMEN

BACKGROUND: Calcific mitral stenosis (calcific MS) presents a challenge for surgical treatment and is a contraindication for most contemporary transcatheter mitral valve replacement devices (TMVR), rendering patients with very limited therapeutic options. AIMS: This study aims to assess the clinical and hemodynamic follow-up after mitral valve lithotripsy (MVL). METHODS: All consecutive patients who underwent MVL to treat symptomatic calcific MS at St Michael's Hospital, Toronto, Canada, were included. Patients were deemed unsuitable for mitral surgery or TMVR after heart team assessment. Patients with rheumatic MS or ≥moderate mitral regurgitation (MR) were excluded. The primary endpoint was a reduction in the invasive mitral gradient by ≥50% without significant (≥moderate) MR. RESULTS: Fifteen patients underwent MVL between 2021 and 2023 with a mean age of 74 ± 9 years; 53% were female, with a mean STS score of 10% ± 0.1%. Following MVL, there was a reduction in the invasively measured mean trans-mitral gradient compared to baseline (14 mmHg vs. 6 mmHg; p < 0.05). The primary endpoint was achieved in 8 patients (53%) with no major procedural complications. At follow-up (median 90 days, IQR 58-115 days), 14 (93%) patients reported improved symptoms from New York Heart Association (NYHA) Class III-IV to NYHA Class I-II (p < 0.01) with stable echo-derived mean gradient (7.7 mmHg ± 2 mmHg vs. 8.4 mmHg ± 2.9 mmHg (p = 0.7). CONCLUSIONS: In selected patients with symptomatic inoperable calcific MS, MVL was safe and associated with significant short-term clinical and hemodynamic improvement. MVL may represent a new compassionate therapy for this challenging cohort. Further studies are needed to determine the long-term outcomes and help define the role of IVL technology in treating calcific valvular conditions.


Asunto(s)
Valvuloplastia con Balón , Calcinosis , Hemodinámica , Litotricia , Estenosis de la Válvula Mitral , Válvula Mitral , Recuperación de la Función , Humanos , Femenino , Masculino , Resultado del Tratamiento , Estenosis de la Válvula Mitral/fisiopatología , Estenosis de la Válvula Mitral/diagnóstico por imagen , Estenosis de la Válvula Mitral/terapia , Anciano , Calcinosis/terapia , Calcinosis/fisiopatología , Calcinosis/diagnóstico por imagen , Válvula Mitral/fisiopatología , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Factores de Tiempo , Anciano de 80 o más Años , Estudios Retrospectivos , Persona de Mediana Edad , Ontario
4.
Catheter Cardiovasc Interv ; 102(1): 145-154, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-37178388

RESUMEN

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.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Estudios Prospectivos , Resultado del Tratamiento
5.
Curr Opin Cardiol ; 37(6): 495-501, 2022 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-36094538

RESUMEN

PURPOSE OF REVIEW: The burden of tricuspid regurgitation (TR) is high in the aging population, almost 4% in the age group over 75 have moderate or more TR. This carries a poor prognosis and an increased incidence of mortality, prolonged hospitalization, and rehospitalization in symptomatic patients with severe TR is observed. Percutaneous tricuspid valve intervention has emerged as a viable therapeutic option, with an increasingly large toolbox of both tricuspid repair and replacement devices. The optimal strategy, timing and patient selection for transcatheter intervention are yet to be determined. This review focuses on the current strengths and limitations of transcatheter tricuspid repair vs. replacement, drawing on lessons learned from surgery. RECENT FINDINGS: Early outcome studies have been published in the last 2 years for many of the new percutaneous tricuspid valve devices. We have summarized these results and compared them to surgical tricuspid valve repair and replacement. We found that surgical data shows a tendency to better outcome with tricuspid valve repair compared to replacement. For transcatheter interventions studies comparing repair and replacement are lacking but both interventions show good procedural success rates and are efficient in reducing the grade of tricuspid regurgitation. SUMMARY: Transcatheter tricuspid valve interventions offer a safe and effective alternative to tricuspid surgery or medical therapy. The decision between valve replacement and repair should be based on patient anatomy, operator experience and device availability until head-to-head comparison of different devices are available.


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Anciano , Cateterismo Cardíaco/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Resultado del Tratamiento , Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/cirugía
6.
Catheter Cardiovasc Interv ; 99(4): 1268-1276, 2022 03.
Artículo en Inglés | MEDLINE | ID: mdl-35084803

RESUMEN

OBJECTIVES: The purpose of this study was to characterize the anatomic relationship between the inferior vena cava (IVC) and tricuspid annulus (TA) and its potential impact on the performance of transcatheter TV interventions. BACKGROUND: Transcatheter tricuspid valve (TV) interventions are emerging as a therapeutic alternative for the treatment of severe, symptomatic tricuspid regurgitation (TR). Progression of TR is associated with right heart dilatation. These anatomic changes may distort the IVC-TA relationship and impact successful implantation of transcatheter devices. METHODS: Fifty patients who presented with symptomatic TR for consideration of transcatheter TV therapy with an available CT were included in the study. Comprehensive transesophageal echocardiogram and CT analyses were performed to assess the right-sided cardiac chambers, TA and IVC-TA relationship. RESULTS: The mean age of the study cohort was 78.4 ± 8.9 years. Torrential TR was present in 54% (n = 27). There was considerable variation in the short axis mid-IVC to mid-TA offset (SAXMID 18.2 ± 7.9 mm, range 4.7-42.1 mm). CONCLUSIONS: The IVC-to-TA relationship exhibits significant variability in patients with symptomatic TR. CT analysis of the tricuspid anatomy, including the relationship to the surrounding structures and the IVC, is essential for planning transcatheter TV interventions. Further studies are needed to define whether the IVC-to-TA relationship is a predictor of technical success in the context of specific transcatheter delivery systems.


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Anciano , Anciano de 80 o más Años , Humanos , Resultado del Tratamiento , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/cirugía , Vena Cava Inferior/diagnóstico por imagen
7.
Curr Opin Cardiol ; 36(2): 148-153, 2021 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-33394712

RESUMEN

PURPOSE OF REVIEW: The combination of mitral regurgitation and tricuspid regurgitation is common in patients with multiple valvular disease and patient management can be challenging. Surgical combined mitral and tricuspid valve surgery is a treatment option for patients meeting criteria but has demonstrated inconsistent long-term benefits. RECENT FINDINGS: Transcatheter mitral and tricuspid edge-to-edge repair has demonstrated early promising results in patients with a prohibitive surgical risk, making it an interesting treatment option. The present review will discuss the physiopathology of this complex disease and contemporary data regarding treatment options for the treatment of combined mitral and tricuspid regurgitation. SUMMARY: Combined transcatheter mitral and tricuspid edge-to-edge repair is a novel treatment option for patients with multiple valvular disease. Further studies are needed to determine optimal patient selection and timing of intervention and demonstrate survival benefit and improvement in clinical outcomes. Advances in technology, with dedicated devices and enhanced imaging techniques may also improve patient outcomes.


Asunto(s)
Insuficiencia Cardíaca , Implantación de Prótesis de Válvulas Cardíacas , Cateterismo Cardíaco , Insuficiencia Cardíaca/terapia , Humanos , Resultado del Tratamiento , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/cirugía
8.
Catheter Cardiovasc Interv ; 97(6): 1281-1289, 2021 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-33660364

RESUMEN

OBJECTIVES: We investigated the durability of tricuspid regurgitation (TR) reduction and the clinical outcomes through 12 months after transcatheter tricuspid valve repair (TTVr) with the PASCAL Transcatheter Valve Repair System. BACKGROUND: TTVr has rapidly developed and demonstrated favorable acute outcomes, but longer follow-up data are needed. METHODS: Overall, 30 patients (age 77 ± 6 years; 57% female) received PASCAL implantation from September 2017 to May 2019 and completed a clinical follow-up at 12 months. RESULTS: The TR etiology was functional in 25 patients (83%), degenerative in three (10%), and mixed in two (7%). All patients had TR severe or greater (massive or torrential in 80%) and heart failure symptoms (90% in NYHA III or IV) under optimal medical treatment. Single-leaflet device attachment occurred in two patients. Moderate or less TR was achieved in 23/28 patients (82%) at 30 days, which was sustained at 12 months (86%). Two patients underwent repeat TTVr due to residual torrential TR (day 173) and recurrence of severe TR (day 280), respectively. One-year survival rate was 93%; 6 patients required rehospitalization due to acute heart failure. NYHA functional class I or II was achieved in 90% and 6-minute walk distance improved from 275 ± 122 m at baseline to 347 ± 112 m at 12-month (+72 ± 82 m, p < .01). There was no stroke, endocarditis, or device embolization during the follow-up. CONCLUSIONS: Twelve-month outcomes from this multicenter compassionate use experience with the PASCAL System demonstrated high procedural success, acceptable safety, and significant clinical improvement.


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Femenino , Humanos , Masculino , Factores de Tiempo , Resultado del Tratamiento , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/cirugía
10.
Curr Opin Cardiol ; 34(2): 164-172, 2019 03.
Artículo en Inglés | MEDLINE | ID: mdl-30640744

RESUMEN

PURPOSE OF REVIEW: Worldwide experience in transcatheter tricuspid valve intervention is increasing as more options become available for the treatment of severe tricuspid regurgitation. These devices can be categorized by their primary mechanism of action, including edge-to-edge leaflet devices, space occupying devices, annuloplasty devices, complete valve replacement and caval valve implantation. This review summarizes the current technologies in use, early clinical results and factors that may affect procedural success. RECENT FINDINGS: Almost all transcatheter devices for tricuspid regurgitation are investigational with very limited evidence. The most commonly used device is the MitraClip (Abbott, Santa Clara, CA, USA) edge-to-edge leaflet device, which is often more effective when the leaflet coaptation gap is not too large (ideally under 7 mm). The Tricuspid Cardioband (Edwards Lifesciences, Irvine, CA, USA) annuloplasty device has CE mark approval with promising short-term procedural results. Guideline-based assessment of disease severity and medication optimization is crucial during heart team evaluation of eligibility for intervention. SUMMARY: Although important lessons have been learned thus far regarding patient and device selection for transcatheter tricuspid regurgitation interventions, the field remains young and further research is needed to optimize treatment in terms of who, when and with what device. Our proposed algorithm for patient selection based on current knowledge incorporates both clinical and anatomic factors.


Asunto(s)
Algoritmos , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Selección de Paciente , Insuficiencia de la Válvula Tricúspide , Cateterismo Cardíaco , Humanos , Resultado del Tratamiento , Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/cirugía
11.
Lancet ; 390(10096): 773-780, 2017 Aug 19.
Artículo en Inglés | MEDLINE | ID: mdl-28831993

RESUMEN

BACKGROUND: Severe mitral regurgitation is associated with impaired prognosis if left untreated. Using the devices currently available, transcatheter mitral valve repair (TMVr) remains challenging in complex anatomical situations. We report the procedural and 30-day results of the first-in-man study of the Edwards PASCAL TMVr system. METHODS: In this multicentre, prospective, observational, first-in-man study, we collected data from seven tertiary care hospitals in five countries that had a compassionate use programme in which patients underwent transcatheter mitral valve repair using the Edwards PASCAL TMVr system. Eligible patients were those with symptomatic, severe functional, degenerative, or mixed mitral regurgitation deemed at high risk or inoperable. Safety and efficacy of the procedure were prospectively assessed at device implantation, discharge, and 30 days after device implantation. The key study endpoints were technical success assessed at the end of the procedure and device success 30 days after implantation using the Mitral Valve Academic Research Consortium definitions. FINDINGS: Between Sept 1, 2016, and March 31, 2017, 23 patients (median age 75 years [IQR 61-82]) had treatment for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the Edwards PASCAL TMVr system. At baseline, the median EuroScore II score was 7·1% (IQR 3·6-12·8) and the median Society of Thoracic Surgeons predicted risk of mortality for mitral valve repair was 4·8% (2·1-9·0) and 6·8% (2·9-10·1) for mitral valve replacement. 22 (96%) of 23 patients were New York Heart Association (NYHA) class III or IV at baseline. The implantation of at least one device was successful in all patients, resulting in procedural residual mitral regurgitation of grade 2+ or less in 22 (96%) patients. Six (26%) of 23 patients had two implants. Periprocedural complications occurred in two (9%) of 23 patients (one minor bleeding event and one transient ischaemic attack). Despite the anatomical complexity of mitral regurgitation in the patients in this compassionate use cohort, technical success was achieved in 22 (96%) of 23 patients, and device success at 30 days was achieved in 18 (78%) patients. Three patients (13%) died during the 30 day follow-up. 19 (95%) of 20 patients alive 30 days after implantation were NYHA class I or II. INTERPRETATION: This study establishes feasibility of the Edwards PASCAL TMVr system with a high rate of technical success and reduction of mitral regurgitation severity. Further research is needed on procedural and long-term clinical outcomes. FUNDING: None.


Asunto(s)
Anuloplastia de la Válvula Mitral/métodos , Insuficiencia de la Válvula Mitral/cirugía , Anciano , Anciano de 80 o más Años , Ensayos de Uso Compasivo , Ecocardiografía Doppler en Color , Diseño de Equipo , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Anuloplastia de la Válvula Mitral/instrumentación , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/fisiopatología , Estudios Prospectivos , Resultado del Tratamiento , Disfunción Ventricular Izquierda/etiología
12.
Catheter Cardiovasc Interv ; 92(3): E172-E174, 2018 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-28544247
13.
Curr Opin Cardiol ; 31(2): 169-75, 2016 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-26780480

RESUMEN

PURPOSE OF REVIEW: Guidelines indicate surgical intervention for patients with symptomatic severe mitral regurgitation or signs of left ventricular dilatation or dysfunction. However, many patients do not receive surgery because of age or comorbidities, and have poor outcomes with conservative therapy. Transcatheter mitral repair with MitraClip (Abbott Vascular, IL, USA) has recently emerged as a viable treatment option for high-risk patients with heart failure. This article will review current evidence supporting the use of MitraClip across the spectrum of patient risk and discuss future directions for this technology. RECENT FINDINGS: Both randomized and registry studies have demonstrated the efficacy and safety of MitraClip for mitral regurgitation reduction, with significant improvements in functional class and reductions in heart failure hospitalizations. With increasing global experience, a broader scope of patients and diseases can now be successfully treated, ranging from patients with failed surgical annuloplasty rings to those in cardiogenic shock. Ongoing randomized trials will further define the role of MitraClip in the management of heart failure patients with secondary mitral regurgitation. SUMMARY: MitraClip is a useful therapeutic tool for nonsurgical patients with advanced heart failure and severe mitral regurgitation. Further developments in device design and procedural technique will continue to expand the range of patients who can be treated, with a goal of reducing heart failure hospitalizations and improving quality of life.


Asunto(s)
Insuficiencia Cardíaca/complicaciones , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Válvula Mitral/cirugía , Instrumentos Quirúrgicos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Procedimientos Quirúrgicos Mínimamente Invasivos/instrumentación , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Insuficiencia de la Válvula Mitral/etiología , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/cirugía , Ensayos Clínicos Controlados Aleatorios como Asunto , Ajuste de Riesgo , Resultado del Tratamiento
14.
JACC Cardiovasc Interv ; 17(4): 552-560, 2024 Feb 26.
Artículo en Inglés | MEDLINE | ID: mdl-38418058

RESUMEN

BACKGROUND: Transcatheter tricuspid valve replacement (TTVR) abolishes tricuspid regurgitation (TR) and has emerged as a definitive treatment for TR. OBJECTIVES: The purpose of this multicenter, observational study was to determine the clinical characteristics and short-term outcomes of patients with TR screened for TTVR. METHODS: Patients underwent TTVR screening at 7 centers on a compassionate-use basis. The primary endpoints were NYHA functional class and TR grade at 30-day follow-up. Secondary endpoints included all-cause mortality, heart failure hospitalization, technical success, and reasons for TTVR screening failure. RESULTS: A total of 149 patients (median age 79 years [Q1-Q3: 72-84 years], 54% women) underwent TTVR screening. The TTVR screening failure rate was 74%, mainly related to large tricuspid annular diameter. Patients undergoing TTVR (n = 38) had significant functional improvements (NYHA functional class I or II from 21% to 68%; P < 0.001), with TR ≤1+ in 97% at 30-day follow-up (P < 0.001 from baseline). Technical success was achieved in 91%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 8%, heart failure hospitalization 5%, major bleeding 18%, and reintervention 9%. Patients who failed screening for TTVR and subsequently underwent "bailout" transcatheter edge-to-edge repair (n = 26) had favorable outcomes (NYHA functional class I or II from 27% to 58%; P < 0.001), with TR ≤1+ in 43% at 30-day follow-up (P < 0.001 from baseline). CONCLUSIONS: This first real-world report of TTVR screening demonstrated a high screening failure rate, mainly related to large tricuspid annular diameter. Patients undergoing TTVR had superior TR reduction and symptom alleviation compared with bailout tricuspid transcatheter edge-to-edge repair, at the cost of greater procedural complications.


Asunto(s)
Insuficiencia Cardíaca , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Humanos , Femenino , Anciano , Masculino , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Hemodinámica , Cateterismo Cardíaco/efectos adversos , Resultado del Tratamiento , Recuperación de la Función , Factores de Tiempo , Índice de Severidad de la Enfermedad , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/cirugía , Sistema de Registros
15.
Artículo en Inglés | MEDLINE | ID: mdl-38970594

RESUMEN

3-dimensional (3D) intracardiac echocardiography (ICE) is emerging as a promising complement and potential alternative to transesophageal echocardiography for imaging guidance in structural heart interventions. To establish standardized practices, our multidisciplinary expert position statement serves as a comprehensive guide for the appropriate indications and utilization of 3D-ICE in various structural heart procedures. The paper covers essential aspects such as the fundamentals of 3D-ICE imaging, basic views, and workflow recommendations specifically tailored for ICE-guided structural heart procedures, such as transeptal puncture, device closure of intracardiac structures, and transcatheter mitral and tricuspid valve interventions. Current challenges, future directions, and training requirements to ensure operator proficiency are also discussed, thereby promoting the safety and efficacy of this innovative imaging modality to support expanding its future clinical applications.

16.
EuroIntervention ; 19(6): 512-525, 2023 08 21.
Artículo en Inglés | MEDLINE | ID: mdl-37235388

RESUMEN

BACKGROUND: Transcatheter mitral valve replacement (TMVR) using dedicated devices is an alternative therapy for high-risk patients with symptomatic mitral regurgitation (MR). AIMS: This study aimed to assess the 2-year outcomes and predictors of mortality in patients undergoing TMVR from the multicentre CHOICE-MI Registry. METHODS: The CHOICE-MI Registry included consecutive patients with symptomatic MR treated with 11 different dedicated TMVR devices at 31 international centres. The investigated endpoints included mortality and heart failure hospitalisation rates, procedural complications, residual MR, and functional status. Multivariable Cox regression analysis was applied to identify independent predictors of 2-year mortality. RESULTS: A total of 400 patients, median age 76 years (interquartile range [IQR] 71, 81), 59.5% male, EuroSCORE II 6.2% (IQR 3.8, 12.0), underwent TMVR. Technical success was achieved in 95.2% of patients. MR reduction to ≤1+ was observed in 95.2% at discharge with durable results at 1 and 2 years. New York Heart Association Functional Class had improved significantly at 1 and 2 years. All-cause mortality was 9.2% at 30 days, 27.9% at 1 year and 38.1% at 2 years after TMVR. Chronic obstructive pulmonary disease, reduced glomerular filtration rate, and low serum albumin were independent predictors of 2-year mortality. Among the 30-day complications, left ventricular outflow tract obstruction, access site and bleeding complications showed the strongest impact on 2-year mortality. CONCLUSIONS: In this real-world registry of patients with symptomatic MR undergoing TMVR, treatment with TMVR was associated with a durable resolution of MR and significant functional improvement at 2 years. Two-year mortality was 38.1%. Optimised patient selection and improved access site management are mandatory to improve outcomes.


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Masculino , Anciano , Femenino , Válvula Mitral/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Cateterismo Cardíaco/métodos , Resultado del Tratamiento , Factores de Riesgo , Sistema de Registros
17.
Artículo en Inglés | MEDLINE | ID: mdl-37962288

RESUMEN

BACKGROUND: The CLASP IID (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical) trial is the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive risk patients with significant symptomatic degenerative mitral regurgitation (DMR). OBJECTIVES: The study sought to report primary and secondary endpoints and 1-year outcomes for the full cohort of the CLASP IID trial. METHODS: Prohibitive-risk patients with 3+/4+ DMR were randomized 2:1 (PASCAL:MitraClip). One-year assessments included secondary effectiveness endpoints (mitral regurgitation [MR] ≤2+ and MR ≤1+), and clinical, echocardiographic, functional, and quality-of-life outcomes. Primary safety (30-day composite major adverse events [MAE]) and effectiveness (6-month MR ≤2+) endpoints were assessed for the full cohort. RESULTS: Three hundred patients were randomized (PASCAL: n = 204; MitraClip: n = 96). At 1 year, differences in survival, freedom from heart failure hospitalization, and MAE were nonsignificant (P > 0.05 for all). Noninferiority of the PASCAL system compared with the MitraClip system persisted for the primary endpoints in the full cohort (For PASCAL vs MitraClip, the 30-day MAE rates were 4.6% vs 5.4% with a rate difference of -0.8% and 95% upper confidence bound of 4.6%. The 6-month MR≤2+ rates were 97.9% vs 95.7% with a rate difference of 2.2% and 95% lower confidence bound (LCB) of -2.5%, for, respectively). Noninferiority was met for the secondary effectiveness endpoints at 1 year (MR≤2+ rates for PASCAL vs MitraClip were 95.8% vs 93.8% with a rate difference of 2.1% and 95% LCB of -4.1%. The MR≤1+ rates were 77.1% vs 71.3% with a rate difference of 5.8% and 95% LCB of -5.3%, respectively). Significant improvements in functional classification and quality of life were sustained in both groups (P <0.05 for all vs baseline). CONCLUSIONS: The CLASP IID trial full cohort met primary and secondary noninferiority endpoints, and at 1 year, the PASCAL system demonstrated high survival, significant MR reduction, and sustained improvements in functional and quality-of-life outcomes. Results affirm the PASCAL system as a beneficial therapy for prohibitive-surgical-risk patients with significant symptomatic DMR.

18.
Int J Cardiol ; 390: 131139, 2023 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-37355239

RESUMEN

BACKGROUND: In the first report from the MitraBridge registry, MitraClip as a bridge to heart transplantation (HTx) proved to be at 1-year an effective treatment strategy for 119 patients with advanced heart failure (HF) who were potential candidates for HTx. We aimed to determine if benefits of MitraClip procedure as a bridge-to-transplant persist up to 2-years. METHODS: By the end of the enrollment period, a total of 153 advanced HF patients (median age 59 years, left ventricular ejection fraction 26.9 ± 7.7%) with significant secondary mitral regurgitation, who were potential candidates for HTx and were treated with MitraClip as a bridge-to-transplant strategy, were included in the MitraBridge registry. The primary endpoint was the 2-year composite adverse events rate of all-cause death, first hospitalization for HF, urgent HTx or LVAD implantation. RESULTS: Procedural success was achieved in 89.5% of cases. Thirty-day mortality was 0%. At 2-year, Kaplan-Meier estimates of freedom from primary endpoint was 47%. Through 24 months, the annualized rate of HF rehospitalization per patient-year was 44%. After an overall median follow-up time of 26 (9-52) months, elective HTx was successfully performed in 30 cases (21%), 19 patients (13.5%) maintained or obtained the eligibility for transplant, and 32 patients (22.5%) no longer had an indication for HTx because of significant clinical improvement. CONCLUSIONS: After 2-years of follow-up, the use of MitraClip as a bridge-to-transplant was confirmed as an effective strategy, allowing elective HTx or eligibility for transplant in one third of patients, and no more need for transplantation in 22.5% of cases.


Asunto(s)
Insuficiencia Cardíaca , Trasplante de Corazón , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Persona de Mediana Edad , Volumen Sistólico , Función Ventricular Izquierda , Factores de Tiempo , Trasplante de Corazón/efectos adversos , Resultado del Tratamiento , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/cirugía , Sistema de Registros , Implantación de Prótesis de Válvulas Cardíacas/métodos
19.
JACC Case Rep ; 4(9): 519-522, 2022 May 04.
Artículo en Inglés | MEDLINE | ID: mdl-35573855

RESUMEN

Acute afterload mismatch and left ventricular dysfunction after mitral valve repair are well established. The impact of transcatheter tricuspid valve repair (TTVr) on right ventricular (RV) function is less clearly defined. To our knowledge, there are no reports of acute RV dysfunction after TTVr. Here we report a case of acute afterload mismatch after successful TTVr. (Level of Difficulty: Advanced.).

20.
Interv Cardiol Clin ; 11(1): 103-112, 2022 01.
Artículo en Inglés | MEDLINE | ID: mdl-34838293

RESUMEN

The prevalence of severe tricuspid regurgitation in older patients is high, and the clinical relevance is perceived more and more in recent years. Many of these patients are not suitable for surgery because of their age and comorbidities. Therefore, a variety of percutaneous interventions have been developed to address this unmet need. Procedural success strongly depends on adequate imaging during the intervention. Although transesophageal echocardiography is the standard of care, imaging may be limited due to anatomic factors and adverse acoustic shadowing. In this review, we discuss the current and future role of intracardiac echocardiography in tricuspid valve interventions.


Asunto(s)
Insuficiencia de la Válvula Tricúspide , Anciano , Ecocardiografía Transesofágica , Humanos , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/cirugía
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