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BACKGROUND: Transcatheter mitral valve replacement (TMVR) faces anatomical challenges, currently limiting widespread adoption. OBJECTIVES: To describe the natural history and prognosis of patients ineligible for various TMVR devices. METHODS: During a 4-year period (2019-2023) 3 TMVR devices (SAPIEN M3, Intrepid and Alta Valve) became available at a single institution (The Christ Hospital, Cincinnati, OH) in the setting of pivotal clinical trials or early feasibility study. Consenting patients who were deemed ineligible ≥1 of these trials were prospectively studied to capture anatomical reasons for ineligibility, cross-over to alternative mitral valve therapies (surgery or high-risk mitral transcatheter edge to edge repair [M-TEER]), and clinical events. RESULTS: A total of 61 patients (out of 71 consenting patients or 85.9 %) were deemed ineligible for TMVR during the study period. The mean age was 79.2 ± 8.8 years, 65.6 % were female, with elevated surgical risk (median STS 4.3, IQR: 2.7-7.3). The 2 most common anatomical reasons for ineligibility were increased risk of left ventricular outflow tract obstruction (LVOTO) (n = 24, 39.3 %) and annular size (n = 29, 47.5 %). During follow-up (median 277 [162-555] days) there were 7 deaths (11.5 %) and 12 (19.7 %) hospitalizations for heart failure. Management strategies included high-risk M-TEER in 11 patients (1 death [9.0 %], 0 HF hospitalizations [0 %]), surgery in 9 patients (0 deaths, 1 HF hospitalizations [11.1 %]), and medical management in 41 patients (6 deaths [14.6 %], 11 HF hospitalizations [26.8 %]) (p = 0.715 for mortality and p = 0.093 for HF hospitalizations). Residual MR ≥ moderate was 0 %, 50 %, and 100 % for surgery, M-TEER and medical treatment, respectively (p < 0.001). CONCLUSIONS: One third of patients deemed ineligible for TMVR are candidates for high-risk M-TEER or surgery with acceptable morbidity and mortality. Our results have practical implications for patient management.
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Cateterismo Cardíaco , Definição da Elegibilidade , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Valva Mitral , Seleção de Pacientes , Humanos , Feminino , Masculino , Idoso , Valva Mitral/cirurgia , Valva Mitral/fisiopatologia , Valva Mitral/diagnóstico por imagem , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/mortalidade , Idoso de 80 Anos ou mais , Fatores de Risco , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/mortalidade , Resultado do Tratamento , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/fisiopatologia , Fatores de Tempo , Medição de Risco , Estudos Prospectivos , Recuperação de Função Fisiológica , Desenho de Prótese , Tomada de Decisão ClínicaRESUMO
Background: Severe calcific aortic stenosis (AS) can be successfully treated with transcatheter aortic valve replacement (TAVR) using both balloon-expandable valves (BEV) and self-expanding valves. Challenges remain for treatment of AS with TAVR in relation to the severity of calcification involving valve leaflets, aortic annulus, and/or left ventricular outflow tract. Severe calcification presents challenges to TAVR with respect to aortic root/annular rupture and risk for peri-valve leak (PVL). Methods: Three separate patients with symptomatic severe AS and severely calcified valves underwent TAVR with BEV. Case 1 underwent TAVR without preceding intravascular lithotripsy (IVL) of the native valve and developed annular rupture requiring surgical rescue. Following this experience, TAVR in 2 subsequent cases was preceded by Shockwave IVL using a novel 12-mm × 30-mm L6 balloon placed across the native valve prior to BEV implantation. Results: Following IVL, cases 2 and 3 had uncomplicated TAVR with excellent valve frame expansion, and no significant residual gradient or PVL. Conclusions: Severely calcified aortic valves increase the risk of aortic annular rupture and PVL following TAVR. IVL prior to TAVR may enhance leaflet/ annular compliance with the potential to improve the safety and effectiveness of TAVR.
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Background: Transcatheter mitral valve replacement (TMVR) is evolving; however, limitations include severe calcification of the mitral valve leaflets and mitral annular calcification (MAC), which may be associated with incomplete valve expansion. Shockwave intravascular lithotripsy (IVL)-assisted percutaneous mitral valvuloplasty to treat calcific mitral stenosis has been reported. We describe the first human use of IVL-assisted transseptal TMVR with the Intrepid valve to treat a severely calcified mitral valve in a patient with severe stenosis and regurgitation. Methods: An 83-year-old man with rheumatic heart disease and severe MAC (MAC score, 10; calcium volume score, 7756 cm3) presented with combined mitral stenosis and regurgitation (valve area, 1.5 cm2; 3+ mitral regurgitation [MR]) and medically refractory heart failure symptoms and was enrolled into the APOLLO (Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation) trial of Intrepid valve TMVR. Transseptal implantation of a 48-mm Intrepid valve was facilitated by Shockwave IVL delivered via two 8.0 × 60-mm M5+ balloons placed across the mitral annulus before implantation. Cerebral embolic protection during IVL and valve implant was provided by a Sentinel device and left subclavian balloon occlusion. Results: Despite initial postimplant valve frame deformation and moderate central MR, postdilation achieved valve frame expansion and reduced MR. Echocardiography and computed tomography performed before hospital discharge and at 30 days show progressive valve frame expansion in the anteroposterior dimension, increased valve area, and resolution of MR. Conclusions: Intravascular lithotripsy of severe MAC before self-expanding TMVR may enhance annular compliance, mitigate fibroelastic recoil, and minimize TMVR valve frame deformation. Although promising, further study is required before IVL is considered a routine adjunct for TMVR in severe MAC.
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BACKGROUND: Mitral valve transcatheter edge-to-edge repair is safe and effective in treating degenerative mitral regurgitation (DMR) patients at prohibitive surgical risk, but outcomes in complex mitral valve anatomy patients vary. OBJECTIVES: The PASCAL IID registry assessed safety, echocardiographic, and clinical outcomes with the PASCAL system in prohibitive risk patients with significant symptomatic DMR and complex mitral valve anatomy. METHODS: Patients in the prospective, multicenter, single-arm registry had 3+ or 4+ DMR, were at prohibitive surgical risk, presented with complex anatomic features based on the MitraClip instructions for use, and were deemed suitable for the PASCAL system by a central screening committee. Enrolled patients were treated with the PASCAL system. Safety, effectiveness, and functional and quality-of-life outcomes were assessed. Study oversight also included an echocardiographic core laboratory and clinical events committee. RESULTS: The study enrolled 98 patients (37.2% ≥2 independent significant jets, 15.0% severe bileaflet/multi scallop prolapse, 13.3% mitral valve orifice area <4.0 cm2, and 10.6% large flail gap and/or large flail width). The implant success rate was 92.9%. The 30-day composite major adverse event rate was 11.2%. At 6 months, 92.4% patients achieved MR ≤2+ and 56.1% achieved MR ≤1+ (P < 0.001 vs baseline). The Kaplan-Meier estimates for survival, freedom from major adverse events, and heart failure hospitalization at 6 months were 93.7%, 85.6%, and 92.6%, respectively. Patients experienced significant symptomatic improvement compared with baseline (P < 0.001). CONCLUSIONS: The outcomes of the PASCAL IID registry establish the PASCAL system as a useful therapy for prohibitive surgical risk DMR patients with complex mitral valve anatomy. (PASCAL IID Registry within the Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID] NCT03706833).
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Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Estudos Prospectivos , Resultado do Tratamento , Implante de Prótese de Valva Cardíaca/efeitos adversos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Cateterismo Cardíaco/efeitos adversosRESUMO
BACKGROUND: Favorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy. OBJECTIVES: The authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry. METHODS: Patients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Study oversight included a central screening committee, echocardiographic core laboratory, and clinical events committee. RESULTS: Ninety-eight patients were enrolled. One-year Kaplan-Meier (KM) estimates of freedom from composite major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively. Significant mitral regurgitation (MR) reduction was achieved at 1 year (P < 0.001 vs baseline) including 93.2% at MR ≤2+ and 57.6% at MR ≤1+ with improvements in related echocardiographic measures. NYHA functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (P < 0.001 vs baseline). CONCLUSIONS: At 1 year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy.
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Cateterismo Cardíaco , Insuficiência da Valva Mitral , Humanos , Cateterismo Cardíaco/efeitos adversos , Ecocardiografia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Resultado do Tratamento , Ensaios Clínicos como AssuntoRESUMO
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.
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BACKGROUND: Severe symptomatic degenerative mitral regurgitation (DMR) has a poor prognosis in the absence of treatment, and new transcatheter options are emerging. OBJECTIVES: The CLASP IID (Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial) randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared with the MitraClip system in patients with significant symptomatic DMR. This report presents the primary safety and effectiveness endpoints for the trial. METHODS: Patients with 3+ or 4+ DMR at prohibitive surgical risk were assessed by a central screening committee and randomized 2:1 (PASCAL:MitraClip). Study oversight also included an echocardiography core laboratory and a clinical events committee. The primary safety endpoint was the composite major adverse event rate at 30 days. The primary effectiveness endpoint was the proportion of patients with mitral regurgitation (MR) ≤2+ at 6 months. RESULTS: A prespecified interim analysis in 180 patients demonstrated noninferiority of the PASCAL system vs the MitraClip system for the primary safety and effectiveness endpoints of major adverse event rate (3.4% vs 4.8%) and MR ≤2+ (96.5% vs 96.8%), respectively. Functional and quality-of-life outcomes significantly improved in both groups (P < 0.05). The proportion of patients with MR ≤1+ was durable in the PASCAL group from discharge to 6 months (PASCAL, 87.2% and 83.7% [P = 0.317 vs discharge]; MitraClip, 88.5% and 71.2% [P = 0.003 vs discharge]). CONCLUSIONS: The CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met noninferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR.
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Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Cateterismo Cardíaco/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Qualidade de Vida , Resultado do TratamentoRESUMO
BACKGROUND: The aim of this study was to examine the relationship between baseline left ventricular (LV) geometry and outcomes after transcatheter aortic valve replacement (TAVR). METHODS: Patients undergoing TAVR (n = 206) had baseline LV geometry classified as (1) concentric hypertrophy, (2) eccentric hypertrophy, (3) concentric remodeling, or (4) normal. Descriptive statistics, Kaplan-Meier time-to-event analysis, and Cox regression were performed. RESULTS: Distribution of baseline LV geometry differed between male and female patients (χ2 = 16.83, P = .001) but not at 1 month (χ2 = 2.56, P = .47) or 1 year (χ2 = 5.68, P = .13). After TAVR, a majority of patients with concentric hypertrophy evolved to concentric remodeling. Survival differed across LV geometry groups at 1 year (χ2[3] = 8.108, P = .044, log-rank test) and at 6.5 years (χ2[3] = 9.023, P = .029, log-rank test). Compared with patients with concentric hypertrophy, patients with normal geometry (hazard ratio, 2.25; 95% CI, 1.12-4.54; P = .023) and concentric remodeling (hazard ratio, 1.89; 95% CI, 1.12-3.17; P = .016) had higher rates of all-cause mortality. CONCLUSIONS: Baseline concentric hypertrophy confers a survival advantage after TAVR. Although baseline patterns of LV geometry appear gender specific (with women demonstrating more concentric hypertrophy), this difference resolves after TAVR.
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Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Feminino , Humanos , Hipertrofia Ventricular Esquerda/diagnóstico por imagem , Masculino , Fatores de Risco , Fatores Sexuais , Função Ventricular Esquerda , Remodelação VentricularRESUMO
INTRODUCTION: Conduction abnormalities after transcatheter aortic valve replacement (TAVR) account for a high percentage of post-TAVR complications. Areas covered: The etiology of conduction abnormalities is closely tied to cardiac anatomy (length of membranous septum, degree of calcification, location of left bundle within the membranous septum), baseline conduction abnormalities (preprocedure right bundle branch block), and procedural variables (type of valve, depth of implant). Management of new high-grade AV block and new left bundle branch block varies by institution in the absence of consensus guidelines. Expert opinion: Authors describe the incidence, etiology, outcomes, and management of conduction abnormalities related to aortic stenosis and TAVR.
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Estenose da Valva Aórtica/cirurgia , Bloqueio Cardíaco/terapia , Próteses Valvulares Cardíacas/efeitos adversos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Valva Aórtica/cirurgia , Bloqueio Cardíaco/epidemiologia , Bloqueio Cardíaco/etiologia , Humanos , Incidência , Resultado do TratamentoRESUMO
Objective: Conduction damage following transcatheter aortic valve implantation (TAVI) remains common. Anatomical risk factors remain elusive. We assessed the impact of variability in the dimensions of the membranous septum and position of the aortic root on the occurrence of conduction damage following TAVI. Methods: The dimensions of the membranous septum, the rotational position of the aortic root correlating to variability in the central fibrous body width, and wedging of the aortic root were assessed on pre-TAVI CT datasets. The depth of implantation was measured from the final aortic angiogram. The variables were compared with the occurrence of both permanent pacemaker insertion (PPI) and left bundle branch block (LBBB) following TAVI. Results: Of 200 patients who met inclusion criteria (mean age = 81 years ± 7.7, 49% men), 20.5 % underwent PPI after TAVI. New LBBB occurred in 23.5%, 21.3 % of whom required PPI. Preprocedural right bundle branch block (OR = 7.00; CI 3.13 to 15.64), valve type (OR=2.35; CI 1.13 to 4.87), depth of implantation (OR=1.62; CI 1.01 to 2.61) and the difference between depth of implantation and the distance from the virtual basal ring to the inferior margin of the membranous septum (OR=0.61; CI 0.38 to 0.99) were all associated with PPI, with similar associations with LBBB. No gross anatomical variable alone was associated with conduction damage. Conclusions: Gross anatomical variation of the aortic root and its underlying support, including the membranous septum, were not associated with the occurrence of either PPI or new LBBB. Procedural characteristics associated with these adverse outcomes suggest that the depth of implantation and radial force of the bioprosthesis, regardless of gross anatomical variability, increase the risk for conduction damage.
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BACKGROUND: Left ventricular filling pressure (LVFP) has been demonstrated to be a major predictor of poor cardiovascular outcomes. However, estimation of LVFP in patients with aortic stenosis is limited by the high prevalence of significant mitral annular calcification. The aim of this study was to investigate the effect of transcatheter aortic valve replacement on LVFP and the relationship of LVFP to mortality and hospitalization. METHODS: This was a single-center, retrospective study of 140 consecutive patients in sinus rhythm with significant mitral annular calcification who underwent transcatheter aortic valve replacement for severe aortic stenosis from May 2011 to June 2015. Mean follow-up duration was 3.06 ± 1.48 years (minimum, 2.4 years; maximum, 6.5 years). Diastolic function was assessed using recently proposed criteria for those with significant mitral annular calcification. High LVFP was defined as a mitral E/A ratio > 1.8 or a ratio of 0.8 to 1.8 and isovolumic relaxation time < 80 msec. RESULTS: At baseline, the proportion of patients with high LVFP was 40.7%, similar to 1 month (39.7%) (P = .86). However, the proportion of patients with high LVFP was significantly decreased at 1 year compared with those at baseline (26.9% vs 40.7%, P = .02). Multivariate analysis showed that high LVFP at baseline significantly increased risk for all-cause mortality compared with patients with normal LVFP (hazard ratio, 2.84; 95% confidence interval, 1.33-6.05; P = .007). CONCLUSIONS: High baseline LVFP was associated with a significantly increased all-cause mortality, and LVFP does not improve in the short term but only at 1 year after transcatheter aortic valve replacement.
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Estenose da Valva Aórtica/cirurgia , Ventrículos do Coração/fisiopatologia , Estenose da Valva Mitral/etiologia , Valva Mitral/diagnóstico por imagem , Substituição da Valva Aórtica Transcateter/métodos , Função Ventricular Esquerda/fisiologia , Pressão Ventricular/fisiologia , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/mortalidade , Calcinose/complicações , Calcinose/diagnóstico , Calcinose/fisiopatologia , Causas de Morte/tendências , Diástole , Ecocardiografia Doppler , Feminino , Seguimentos , Ventrículos do Coração/diagnóstico por imagem , Humanos , Masculino , Estenose da Valva Mitral/diagnóstico , Estenose da Valva Mitral/mortalidade , Estenose da Valva Mitral/fisiopatologia , Estudos Retrospectivos , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
OBJECTIVES: Calcific aortic valve disease (CAVD) is a progressive disease ranging from aortic valve (AoV) sclerosis to AoV stenosis (AS), characterised by severe calcification with impaired leaflet function. Due to the lack of early symptoms, the pathological progression towards valve dysfunction is poorly understood. The early patterns of AoV calcification and altered extracellular matrix (ECM) organisation were analysed in individuals postmortem without clinical AS compared with clinical AS. METHODS: Histological patterns of calcification and ECM organisation in postmortem AoV leaflets without clinical AS obtained from a tissue repository and surgical specimens obtained from individuals with clinical AS were compared with in vivo imaging prior to transcatheter AoV implantation. RESULTS: AoV calcification was detected in all samples from individuals >50 years old, with severity increasing with age, independent of known CAVD risk factors. Two distinct types of calcification were identified: 'Intrinsic', primarily found at the leaflet hinge of postmortem leaflets, accompanied by abnormal collagen and proteoglycan deposition; and 'Nodular', extending from the middle to the tip regions in more severely affected postmortem leaflets and surgical specimens, associated with increased elastin fragmentation and loss of elastin integrity. Even in the absence of increased thickening, abnormalities in ECM composition were observed in postmortem leaflets without clinical AS and worsen in clinical AS. CONCLUSIONS: Two distinct phenotypes of AoV calcification are apparent. While the 'nodular' form is recognised on in vivo imaging and is present with CAVD and valve dysfunction, it is unclear if the 'intrinsic' form is pathological or detected on in vivo imaging.
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Estenose da Valva Aórtica/patologia , Valva Aórtica/patologia , Calcinose/patologia , Matriz Extracelular/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Autopsia , Biópsia , Calcinose/diagnóstico por imagem , Calcinose/cirurgia , Estudos de Casos e Controles , Progressão da Doença , Tecido Elástico/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fenótipo , Índice de Gravidade de Doença , Tomografia Computadorizada por Raios X , Substituição da Valva Aórtica Transcateter , Adulto JovemRESUMO
OBJECTIVES: To investigate the feasibility and image quality of low-dose contrast computed tomography (CT) angiography with pulmonary artery (PA) protocol. BACKGROUND: Aortic stenosis is the most common valvular heart disease and transcatheter aortic valve replacement (TAVR) has evolved as an alternative method for surgical valve replacement in intermediate-risk and high-risk surgical patients. CT is essential for measurement of aortic annulus prior to TAVR. METHODS: Twenty patients underwent a low-dose contrast study with PA protocol and 20 patients underwent a traditional-dose study (traditional protocol). In PA protocol, the pigtail catheter was advanced in the main pulmonary artery under fluoroscopic guidance, with a second pigtail placed in the abdominal aorta. The pigtail catheter and sheath were secured in position and the patient was taken to the CT scan area for CT angiography of the chest (with injection from the PA catheter), abdomen, and pelvis (with injection from abdominal aortic catheter). RESULTS: The amount of contrast used was significantly lower in the PA protocol vs the traditional protocol (40 mL vs 99.50 ± 6.87 mL; P<.001) at the cost of reduced average signal (265 ± 60 HU vs 371 ± 70 HU; P<.001), but without affecting measurements of the aortic annulus. Furthermore, no statistically significant difference in serum creatinine concentration was observed before and 48 hours after contrast administration in the PA group. CONCLUSION: Our data provide evidence that the new PA technique can be performed safely with much lower volume of CT contrast without affecting assessment of aortic annulus size.
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Estenose da Valva Aórtica/diagnóstico por imagem , Angiografia por Tomografia Computadorizada/métodos , Meios de Contraste , Segurança do Paciente , Artéria Pulmonar , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/terapia , Distribuição de Qui-Quadrado , Estudos de Coortes , Estudos de Viabilidade , Feminino , Humanos , Injeções Intra-Arteriais , Masculino , Prognóstico , Estudos Retrospectivos , Estatísticas não Paramétricas , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
OBJECTIVES: We examined the echocardiographic characteristics of highly trained American football players. BACKGROUND: Intense physical training is associated with morphologic and physiologic cardiac changes often referred to as the "athlete's heart." Echocardiographic features peculiar to elite football players have not been described. METHODS: We studied cardiac morphology and function as assessed by rest and stress echocardiography in 156 asymptomatic National Football League players. Resting and stress ejection fraction (EF), wall thickness, and diastolic left ventricular internal diameter (LVID) were measured. Left ventricular (LV) mass was calculated, as was relative wall thickness (RWT) defined as septal and posterior wall thickness divided by LVID. Control data were obtained from published studies. RESULTS: The mean LVID (53 +/- 0.5 mm) and maximal wall thickness (11.2 +/- 0.2 mm) were increased over normal reported control subjects. There was a correlation between LVID and body weight (p = 0.01) and body surface area (BSA) (p = 0.01). The average LVID indexed to BSA was 23 +/- 2 mm/M(2). There was also a correlation between maximal wall thickness and body weight (p = 0.01) and BSA (p = 0.01). The average wall thickness indexed to BSA was 5.05 +/- 0.88 mm/M(2). Of the players, 23% had evidence of LV hypertrophy. Two players had an increased septal-to-posterior-wall-thickness ratio (> or =1.3), although no player had an outflow gradient. The RWT for the players was 0.424 (+/- 0.1). The mean resting EF was 58% (+/- 4.4%), and every player undergoing exercise testing had an appropriate hyperdynamic response in cardiac function. CONCLUSIONS: Both wall thickness and LVID of elite American football players are increased and correlate with body size. There is a high RWT, reflecting an emphasis on strength training. The LV EF was normal and not supranormal, as is sometimes believed. Regardless of the resting EF, all players had hyperdynamic cardiac responses with exercise.
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Futebol Americano , Ventrículos do Coração/anatomia & histologia , Hipertrofia Ventricular Esquerda/diagnóstico por imagem , Adulto , Superfície Corporal , Ecocardiografia sob Estresse , Ventrículos do Coração/diagnóstico por imagem , Humanos , Hipertrofia Ventricular Esquerda/fisiopatologia , MasculinoRESUMO
The past decade has seen major advances in adjunctive pharmacotherapy for percutaneous coronary intervention. Pharmacological therapeutic advances have resulted from a greater understanding of the pathophysiological mechanisms underlying platelet activation and aggregation, thrombin generation and thrombus formation. Specifically, refinements in the use of unfractionated heparin, developments in the use of low molecular weight heparins and direct antithrombin agents as well as improvement in both oral and parenteral adjunctive antiplatelet therapies have occurred and are reviewed herein.
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Angioplastia Coronária com Balão , Trombose Coronária/prevenção & controle , Anticoagulantes/administração & dosagem , Anticoagulantes/uso terapêutico , Aspirina/administração & dosagem , Aspirina/uso terapêutico , Ensaios Clínicos como Assunto , Quimioterapia Combinada , Fibrinolíticos/administração & dosagem , Fibrinolíticos/uso terapêutico , Heparina/administração & dosagem , Heparina/uso terapêutico , Humanos , Período Intraoperatório , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/uso terapêutico , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Piridinas/administração & dosagem , Piridinas/uso terapêutico , Trombina/antagonistas & inibidoresRESUMO
The clinical consequences of stent thrombosis are frequently catastrophic. This article reviews the factors previously implicated in the occurrence of stent thrombosis and analyzes recent reports of thrombosis involving a new sirolimus-eluting stent (Cypher). Factors associated with stent thrombosis include intrinsic stent thrombogenicity and patient-, target lesion-, and procedure-related issues. Stent design may influence the degree of platelet activation after coronary stent deployment. In drug-eluting stents, the mechanical properties of the bare metal stent platform might be altered by the polymer coating, and the propensity for thrombosis might be influenced by both the polymer coating and the medication with which it is impregnated. Cumulative data for the Cypher stent do not suggest a propensity for thrombosis, but several caveats should be observed to enhance the safety of the device.
Assuntos
Stents/efeitos adversos , Trombose/etiologia , Segurança de Equipamentos , Humanos , Polímeros , Desenho de PróteseRESUMO
Although randomized clinical trials have demonstrated efficacy of coronary irradiation versus placebo for the treatment of in-stent restenosis (ISR), durable long-term benefit in community practice is less well defined. From January 1, 2001, through June 30, 2002, consecutive percutaneous coronary intervention (n = 3,869) were analyzed at our center with a total of 330 patients undergoing coronary irradiation for ISR (53, Ir192; 12, P32; 265 Novoste Sr90). Novoste Sr90 was successfully performed in 265 of 270 (98%) of patients attempted by 10 operators. The mean patient age was 63 years (range 35 90) with 55% male (145/265) and 45% female (120/265). ISR anatomic subsets included multi-lesion (45/265; 17%), multi-vessel (27/265; 10.0%) and saphenous vein graft (16/265; 6.0%) interventions. At a mean follow-up of 10.5 2.8 (SD) months, fifty-three (20%) of the Novoste Sr90 treated patients had returned for symptoms requiring repeat angiography. Of these, 23 patients had repeat percutaneous coronary intervention (PCI) including 2 target site revascularizations (TSR), twelve non-TSR (distinct from the radiated segment of the target vessel), and 9 non-target vessel revascularizations (TVR). Coronary artery bypass surgery was performed in 11 total patients, 4 due to TSR, and 7 due to non-TVR. Clinical TSR was 2.3% (6/265) and TVR was 6.8% (18/265). In conclusion, the Novoste SR90 Beta-Cath System for the treatment of ISR is associated with a high procedural success rate and low TSR and TVR. Revascularization in follow-up is predominantly due to progressive disease outside the radiated segment and aggressive secondary prevention, especially prolonged anti-platelet therapy, appear critical to long-term procedural success.