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1.
Eur Heart J ; 44(15): 1331-1339, 2023 04 17.
Artículo en Inglés | MEDLINE | ID: mdl-36883599

RESUMEN

AIMS: Paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The effect of transcatheter interventions to treat PVR after the index TAVI was investigated. METHODS AND RESULTS: A registry of consecutive patients who underwent transcatheter intervention for ≥ moderate PVR after the index TAVI at 22 centers. The principal outcomes were residual aortic regurgitation (AR) and mortality at 1 year after PVR treatment. A total of 201 patients were identified: 87 (43%) underwent redo-TAVI, 79 (39%) plug closure, and 35 (18%) balloon valvuloplasty. Median TAVI-to-re-intervention time was 207 (35; 765) days. The failed valve was self-expanding in 129 (63.9%) patients. The most frequent devices utilized were a Sapien 3 valve for redo-TAVI (55, 64%), an AVP II as plug (33, 42%), and a True balloon for valvuloplasty (20, 56%). At 30 days, AR ≥ moderate persisted in 33 (17.4%) patients: 8 (9.9%) after redo-TAVI, 18 (25.9%) after plug, and 7 (21.9%) after valvuloplasty (P = 0.036). Overall mortality was 10 (5.0%) at 30 days and 29 (14.4%) at 1 year: 0, 8 (10.1%), and 2 (5.7%) at 30 days (P = 0.010) and 11 (12.6%), 14 (17.7%), and 4 (11.4%) at 1 year (P = 0.418), after redo-TAVI, plug, and valvuloplasty, respectively. Regardless of treatment strategy, patients in whom AR was reduced to ≤ mild had lower mortality at 1 year compared with those with AR persisting ≥ moderate [11 (8.0%) vs. 6 (21.4%); P = 0.007]. CONCLUSION: This study describes the efficacy of transcatheter treatments for PVR after TAVI. Patients in whom PVR was successfully reduced had better prognosis. The selection of patients and the optimal PVR treatment modality require further investigation.


Asunto(s)
Insuficiencia de la Válvula Aórtica , Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Pronóstico , Resultado del Tratamiento , Insuficiencia de la Válvula Aórtica/etiología , Insuficiencia de la Válvula Aórtica/cirugía
2.
Catheter Cardiovasc Interv ; 99(1): 171-178, 2022 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-34331844

RESUMEN

OBJECTIVES: The Evolut R FORWARD study confirmed safety and effectivenesss of the Evolut R THV in routine clinical practice out to 1 year. Herein, we report the final 3-year clinical follow up of the FORWARD study. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a proven alternative to surgery in elderly patients with symptomatic severe aortic stenosis. Long-term clinical outcome data with the Evolut R platform are scarce. METHODS: FORWARD is a prospective multicenter observational study that evaluated the Evolut R system in routine clinical practice at 53 centres. Eligible patients had symptomatic native aortic valve stenosis or failed surgical aortic bioprosthesis and elevated operative risk per Heart-Team assessment. TAVR was attempted in 1039 patients. RESULTS: Mean age was 81.8 ± 6.2 years, 64.9% were women, STS score was 5.5 ± 4.5% and 34.2% were frail. Rates of all-cause mortality and disabling stroke were 24.8% and 4.8% at 3 years. Early need for a new pacemaker implantation after TAVR (all-cause mortality: with new PPI; 21.0% vs. without; 22.8%, p = 0.55) and the presence of > trace paravalvular regurgitation (all-cause mortality: no or trace; 22.0% vs. ≥ mild; 25.5%, p = 0.29) did not affect survival. Between 1 and 3 years incidence rates of valve related intervention, endocarditis and clinically relevant valve thrombosis were low. CONCLUSIONS: The Evolut R valve maintained a favorable safety profile through 3 years in routine clinical practice. Rates of transcatheter heart valve-related adverse events were low.


Asunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Femenino , Humanos , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento
3.
Catheter Cardiovasc Interv ; 100(5): 832-838, 2022 11.
Artículo en Inglés | MEDLINE | ID: mdl-36116033

RESUMEN

OBJECTIVE: Patients with rapidly deteriorating clinical status due to severe aortic stenosis are often referred for expedited transcatheter aortic valve replacement (TAVR). Data regarding the outcome of such interventions is limited. We aimed to evaluate the outcome of patients undergoing expedited TAVR. DESIGN AND SETTING: Data were derived from the Israeli Multicenter Registry. SUBJECTS: Subjects were divided into two groups based on procedure urgency: patients who were electively hospitalized for the procedure (N = 3140) and those who had an expedited TAVR (N = 142). Procedural and periprocedural complication rates were significantly higher among patients with an expedited indication for TAVR compared to those having an elective procedure: valve malposition 4.6% versus 0.6% (p < 0.001), procedural cardiopulmonary resuscitation 4.3% versus 1.0% (p = 0.007), postprocedure myocardial infarction 2.0% versus 0.4% (p = 0.002), and stage 3 acute kidney injury 3.0% versus 1.1%, (p < 0.001). Patients with expedited indication for TAVR had significantly higher in hospital mortality (5.6% vs. 1.4%, p = 0.003). Kaplan-Meier's survival analysis showed that patients undergoing expedited TAVR had higher 3-year mortality rates compared to patients undergoing an elective TAVR procedure (p < 0.001). Multivariate analysis found that patients with expedited indication had fourfolds increased risk of in-hospital mortality (odds ratio: 4.07, p = 0.001), and nearly twofolds increased risk of mortality at 3-year (hazard ratio: 1.69, p = 0.001) compared to those having an elective procedure. CONCLUSION: Patients with expedited indications for TAVR suffer from poor short- and long-term outcomes. It is important to characterize and identify these patients before the deterioration to perform TAVR in a fast-track pathway to minimize their procedural risk.


Asunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Resultado del Tratamiento , Índice de Severidad de la Enfermedad , Factores de Riesgo , Catéteres
4.
Cardiology ; 147(4): 367-374, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35358973

RESUMEN

INTRODUCTION: Ostial coronary lesions are a subset of proximal coronary lesions, which are relatively more difficult to treat and were associated with worse clinical outcomes in the early percutaneous coronary intervention (PCI) era. Data regarding the outcomes of ostial lesions' PCI in the contemporary era are lacking. METHODS: We conducted a single-center, all-comer, prospective registry study, enrolling patients undergoing PCI with the use of contemporary drug-eluting stents (DES) between July 2016 and February 2018. Included in the present analysis were only patients treated for proximal lesions. Clinical outcomes were compared between patients undergoing PCI of ostial versus proximal nonostial lesions. The primary endpoint was target vessel revascularization (TVR). Secondary endpoints included target lesion revascularization (TLR) and major cardiovascular adverse events (MACE) at 12 months. RESULTS: A total of 334 (84.7% male, 67.3 ± 10.7 years) patients were included, of which 91 patients were treated for ostial lesions and 243 were treated for proximal nonostial lesions. Baseline and procedural characteristics were similar between the two groups. At 12 months, TVR and TLR were numerically higher among patients undergoing PCI of ostial versus nonostial lesions without reaching statistical significance (5.5% vs. 3.3%; p = 0.35 and 4.4% vs. 2.5%; p = 0.47, respectively). The rate of MACE was similar between the two groups. CONCLUSION: In patients undergoing PCI with the use of contemporary DES, clinical outcomes were similar among patients treated for ostial compared to proximal nonostial lesions. Larger studies are required to further evaluate the performance of contemporary DES in this subset of lesions.


Asunto(s)
Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Enfermedad de la Arteria Coronaria/etiología , Enfermedad de la Arteria Coronaria/cirugía , Femenino , Humanos , Masculino , Intervención Coronaria Percutánea/efectos adversos , Sistema de Registros , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
5.
Isr Med Assoc J ; 24(4): 229-234, 2022 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-35415981

RESUMEN

BACKGROUND: Neutrophil-to-lymphocyte ratio (NLR) is a simple and cost-effective marker of inflammation. This marker has been shown to predict cardiac arrhythmias, progression of valvular heart disease, congestive heart failure decompensation, acute kidney injury, and mortality in cardiovascular patients. The pathologic process of aortic stenosis includes chronic inflammation of the valve and therefore biomarkers of inflammation might offer additive prognostic value. OBJECTIVES: To evaluate NLR and its association with long term mortality in transcatheter aortic valve implantation (TAVI) patients. METHODS: We evaluated data of 1152 consecutive patient from the Tel Aviv Medical Center TAVI registry who underwent TAVI. Data included baseline clinical, demographic, and echocardiographic findings; procedural complications; and post-procedure mortality. Patients were compared by using the median NLR value (4.1) and evaluated for long-term mortality. RESULTS: Patients with NLR above the median had higher mortality rates (26.4% vs. 16.3%, P < 0.001) at 3 years post-procedure. A multivariable analysis found NLR to be an independent risk factor for mortality (hazard ratio = 1.47, 95% confidence interval 1.09-1.99, P = 0.013). In addition, high NLR was linked to complicationsduring and after the procedure. CONCLUSIONS: NLR is an independent prognostic marker among TAVI patients. This marker may represent an increased inflammatory response and should be added to previous known prognostic factors.


Asunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Humanos , Inflamación/complicaciones , Linfocitos , Neutrófilos , Pronóstico , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del Tratamiento
6.
Catheter Cardiovasc Interv ; 98(7): E990-E999, 2021 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-34347381

RESUMEN

OBJECTIVES: This study aimed to compare permanent pacemaker implantation (PPMI) rates among patients undergoing Trans-catheter Aortic Valve Implantation (TAVI) with first generation (G1) versus second generation (G2) valves and the impact of PPMI on long-term mortality. BACKGROUND: PPMI is a known adverse event after TAVI. Recently, two novel iterations of valve designs of both the balloon expandable valves (BEV) and self-expanding valves (SEV) were introduced as a second generation valves. METHODS: All patients included in the Israeli multicenter TAVI registry were grouped according to valve type (BEV vs. SEV) and generation (G1 vs. G2). A comparison was made for clinical and outcome indices of patients undergoing TAVI with G1 and G2 in each of the valve systems. RESULTS: A total of 1377 patients were included. The incidence of PPMI did not differ between G1-BEV versus G2-BEV (15.3% vs. 17.4%; p = 0.598) nor between G1-SEV versus G2-SEV (23.4% vs. 20.3%; p = 0.302). Depth of implantation and complete right bundle branch block were independently associated with PPMI post-TAVI in both valve systems. PPMI was not associated with an increased risk for 2-year mortality. CONCLUSIONS: The incidence of PPMI remains a relevant adverse event post-TAVI even when the newer generation valves are used. Since the predictors for PPMI are well established, a standardized approach for the management of conduction disorders is much needed.


Asunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Marcapaso Artificial , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Humanos , Estudios Retrospectivos , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento
7.
Catheter Cardiovasc Interv ; 98(5): E758-E767, 2021 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-33682347

RESUMEN

OBJECTIVES: Right ventricular (RV) dysfunction and tricuspid regurgitation (TR) are associated with adverse outcomes in severe aortic stenosis (AS) patients. Our aim was to evaluate the association between ≥moderate TR and RV dysfunction on long-term mortality following transcatheter aortic valve replacement (TAVR). METHODS: A retrospective analysis of the Israeli multicenter TAVR registry among 4,344 consecutive patients, with all-cause mortality as the main outcome measure. RESULTS: Echocardiographic assessment of TR grade and RV dysfunction was available for 3,733 and 1,850 patients, of whom ≥moderate TR and RV dysfunction was noted for 478(13%) and 78(4%), respectively. The mean follow-up time was 2.9 ± 2.3 years. In univariate models, ≥Moderate TR and ≥moderate RV dysfunction were associated with increased long-term mortality (HR 1.45, 95% CI 1.24-1.69, p < .001 and HR 1.73, 95% CI 1.21-2.47, p = 0.003, respectively). These finding did not remained significant after adjusting to echocardiographic parameters. A subset of patients with no improvement in RV function had the highest long-term mortality risk (HR 3.3, 95% CI 1.95-5.7, p < .001). CONCLUSION: When adjusted to multiple echocardiographic characteristics baseline ≥Moderate TR and ≥moderate RV dysfunction were not associated with long-term mortality following TAVR. Persistent RV dysfunction following TAVR was associated with the highest risk for mortality.


Asunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Insuficiencia de la Válvula Tricúspide , Disfunción Ventricular Derecha , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Humanos , Pronóstico , Estudios Retrospectivos , Factores de Riesgo , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Disfunción Ventricular Derecha/diagnóstico por imagen , Disfunción Ventricular Derecha/etiología
8.
Eur Heart J ; 41(29): 2731-2742, 2020 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-32592401

RESUMEN

AIMS: Due to bioprosthetic valve degeneration, aortic valve-in-valve (ViV) procedures are increasingly performed. There are no data on long-term outcomes after aortic ViV. Our aim was to perform a large-scale assessment of long-term survival and reintervention after aortic ViV. METHODS AND RESULTS: A total of 1006 aortic ViV procedures performed more than 5 years ago [mean age 77.7 ± 9.7 years; 58.8% male; median STS-PROM score 7.3% (4.2-12.0)] were included in the analysis. Patients were treated with Medtronic self-expandable valves (CoreValve/Evolut, Medtronic Inc., Minneapolis, MN, USA) (n = 523, 52.0%), Edwards balloon-expandable valves (EBEV, SAPIEN/SAPIEN XT/SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) (n = 435, 43.2%), and other devices (n = 48, 4.8%). Survival was lower at 8 years in patients with small-failed bioprostheses [internal diameter (ID) ≤ 20 mm] compared with those with large-failed bioprostheses (ID > 20 mm) (33.2% vs. 40.5%, P = 0.01). Independent correlates for mortality included smaller-failed bioprosthetic valves [hazard ratio (HR) 1.07 (95% confidence interval (CI) 1.02-1.13)], age [HR 1.21 (95% CI 1.01-1.45)], and non-transfemoral access [HR 1.43 (95% CI 1.11-1.84)]. There were 40 reinterventions after ViV. Independent correlates for all-cause reintervention included pre-existing severe prosthesis-patient mismatch [subhazard ratio (SHR) 4.34 (95% CI 1.31-14.39)], device malposition [SHR 3.75 (95% CI 1.36-10.35)], EBEV [SHR 3.34 (95% CI 1.26-8.85)], and age [SHR 0.59 (95% CI 0.44-0.78)]. CONCLUSIONS: The size of the original failed valve may influence long-term mortality, and the type of the transcatheter valve may influence the need for reintervention after aortic ViV.


Asunto(s)
Estenosis de la Válvula Aórtica , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Femenino , Humanos , Masculino , Diseño de Prótesis , Falla de Prótesis , Resultado del Tratamiento
9.
Am Heart J ; 220: 184-191, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-31862472

RESUMEN

BACKGROUND: In contrast to surgical aortic valve replacement, left ventricle (LV) hypertrophy (LVH) had not been clearly associated with mortality following transcatheter aortic valve replacement (TAVR). METHODS: We performed a retrospective analysis of patients enrolled in the Israeli multicenter TAVR registry for whom preprocedural LV mass index (LVMI) data were available. Patients were divided into categories according to LVMI: normal LVMI and mild, moderate, and severe LVH. Mild LVH was regarded as the reference group. Additionally, LV geometry patterns were examined (concentric and eccentric LVH, and concentric remodeling). RESULTS: The cohort consisted of 1,559 patients, 46.5% male, with a mean age of 82.2 (±6.8) years and mean LVMI of 121 (±29) g/m2. Rates of normal LVMI and mild, moderate, and severe LVH were 31% (n = 485), 21% (n = 322), 18% (n = 279), and 30% (n = 475), respectively. Three-year mortality rates for normal LVMI and mild, moderate, and severe LVH were 19.8%, 18.3%, 23.7%, and 24.4%, respectively. Compared to mild LVH, moderate LVH and severe LVH were independently associated with an increased risk for all-cause mortality (hazard ratio [HR] 1.58, 95% CI 1.15-2.18, P = .005; HR 1.46, 95% CI 1.1-1.95, P = .009; respectively). Concentric LVH was independently associated with a decreased risk for mortality compared to normal LV geometry (HR 0.75, 95% CI 0.63-0.89, P = .001). Compared to concentric LVH, eccentric LVH was independently associated with a 33% increased risk for mortality (HR 1.33, 95% CI 1.11-1.60, P = .002). CONCLUSIONS: Mild concentric LVH confers a protective effect among patients with severe aortic stenosis undergoing TAVR. However, hypertrophy becomes maladaptive, and an increased baseline LVMI, eccentric pattern particularly, may be associated with all-cause mortality in this population.


Asunto(s)
Hipertrofia Ventricular Izquierda/mortalidad , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/cirugía , Causas de Muerte , Ecocardiografía , Femenino , Humanos , Hipertrofia Ventricular Izquierda/clasificación , Hipertrofia Ventricular Izquierda/etiología , Hipertrofia Ventricular Izquierda/patología , Israel , Masculino , Evaluación de Resultado en la Atención de Salud , Periodo Preoperatorio , Sistema de Registros , Estudios Retrospectivos , Reemplazo de la Válvula Aórtica Transcatéter/métodos
10.
Catheter Cardiovasc Interv ; 96(7): E695-E702, 2020 12.
Artículo en Inglés | MEDLINE | ID: mdl-32022390

RESUMEN

BACKGROUND: Transcatheter aortic valve implantation (TAVI) for aortic stenosis (AS) risk assessment is still developing and mostly concerned with mortality in the periprocedural period. We therefore sought to develop and then validate a score to predict 1-year adverse outcome. METHODS: Patients that underwent TAVI for severe AS in the Israeli registry. Patients with unsuccessful/suboptimal implantation were excluded. The cohort was split to derivation/validation cohorts by a ratio of 70:30. The outcome was defined as 1-year composite of mortality, stroke, and no improvement in NYHA class (vs. baseline). Logistic regression was used to fit the prediction model. RESULTS: Out of 2,440 patients meeting inclusion criteria, 276 were excluded, leaving 2,160 patients for both cohorts. At 1 year, 299 (14%) patients experienced the adverse ("futile") outcome. The derived prediction model included mean aortic valve (AV) gradient, previous pacemaker, previous oncological disease, need for diuretics, baseline NYHA class, hemoglobin and creatinine levels, and nonfemoral access site. The model's area under the curve (AUC) was 0.69 in the derivation and 0.70 in the validation cohort. Performance of other scores in the validation cohort were lower (0.60 for STS, 0.55 for Euroscore2, 0.56 for TVT score, and 0.53 for TAVI2-score, p = .03). Based on three risk tiers, patients had a low risk (20/306, 7% futility), a medium risk (50/304, 17%), and high risk (18/37, 49%) for futility. CONCLUSIONS: The TAVI futility risk model can be used to provide further insight regarding prediction measures and/or patients' outcomes outside of the periprocedural period (NCT02023060).


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Reglas de Decisión Clínica , Inutilidad Médica , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Femenino , Hemodinámica , Humanos , Israel , Masculino , Valor Predictivo de las Pruebas , Sistema de Registros , Reproducibilidad de los Resultados , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento
11.
Nephrol Dial Transplant ; 35(3): 433-438, 2020 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-30169857

RESUMEN

BACKGROUND: Acute kidney injury (AKI) complicating transcatheter aortic valve implantation (TAVI) is relatively frequent and associated with significant morbidity. Previous studies have shown a higher 30-day and 1-year mortality risk in patients with periprocedural AKI. Our aim was to identify the prognostic impact of periprocedural AKI on long-term follow-up. METHODS: This is a single-center prospective study evaluating patients undergoing TAVI for severe aortic stenosis. AKI was defined according to the Valve Academic Research Consortium 2 definition, as an absolute increase in serum creatinine ≥0.3 mg/dL or an increase >50% within the first week following TAVI. Mortality data were compared between patients who developed AKI and those who did not. Logistic and Cox regressions were used for survival analysis. RESULTS: The final analysis included 1086 consecutive TAVI patients. AKI occurred in 201 patients (18.5%). During the follow-up period, 289 patients died. AKI was associated with an increased risk of 30-day mortality {4.5 versus 1.9% in the non-AKI group; hazard ratio [HR] 3.70 [95% confidence interval (CI) 1.35-10.13]}. Although 1-year mortality was higher in the AKI group in univariate analysis, it was not significant after a multivariate regression. AKI was a strong predictor of longer-term mortality [42.3 versus 22.7% for 7-year mortality; HR 1.71 (95% CI 1.30-2.25)]. In 189 of 201 patients we had data regarding recovery from AKI up to 30 days after discharge. In patients with recovery from AKI, the mortality rate was lower (38.2 versus 56.6% in the nonrecovery group; P = 0.022). CONCLUSIONS: Periprocedural AKI following TAVI is a strong risk factor for short-term as well as long-term mortality (up to 7 years). Therefore more effort is needed to reduce this complication.


Asunto(s)
Lesión Renal Aguda/mortalidad , Estenosis de la Válvula Aórtica/terapia , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Lesión Renal Aguda/etiología , Lesión Renal Aguda/patología , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Prospectivos , Factores de Riesgo , Tasa de Supervivencia
12.
Eur Heart J ; 40(38): 3169-3178, 2019 10 07.
Artículo en Inglés | MEDLINE | ID: mdl-31120108

RESUMEN

AIMS: Acute kidney injury (AKI) is a common complication following transcatheter aortic valve implantation (TAVI) and is associated with increased risk for short- and long-term mortality. In patients undergoing percutaneous coronary intervention (PCI), forced diuresis with matched hydration has been shown to reduce the incidence of AKI by ∼50%. The aim of the present study was to evaluate whether forced diuresis with matched intravenous hydration reduces AKI in patients undergoing TAVI. METHODS AND RESULTS: Reducing Acute Kidney Injury (REDUCE-AKI) was a single-centre, prospective, randomized, double-blind sham-controlled clinical trial, designed to examine the effect of an automated matched saline infusion with urine output for the prevention of AKI in patients undergoing TAVI. A total of 136 TAVI patients were randomized, 68 in each group. Mean age was 83.9 ± 5 years and 41.2% were males. There were no differences in baseline characteristics between the two groups. The rate of AKI was not statistically different between the groups (25% in the active group vs. 19.1% in the sham group, P = 0.408). There was a significant increase in long-term mortality in the active group (27.9% vs. 13. 2% HR 3.744, 95% CI 1.51-9.28; P = 0.004). The study was terminated prematurely by the Data Safety Monitoring Board for futility and a possible signal of harm. CONCLUSIONS: Unlike in PCI, forced diuresis with matched hydration does not prevent AKI in patients undergoing TAVI, and might be associated with increased long-term mortality. Future studies should focus on understanding the mechanisms behind these findings. CLINICALTRIALS.GOV REGISTRATION: NCT01866800, 30 April 2013.


Asunto(s)
Lesión Renal Aguda , Válvula Aórtica/cirugía , Diuresis , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Complicaciones Posoperatorias , Lesión Renal Aguda/etiología , Lesión Renal Aguda/prevención & control , Lesión Renal Aguda/terapia , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/cirugía , Método Doble Ciego , Femenino , Fluidoterapia/métodos , Fluidoterapia/mortalidad , Humanos , Masculino , Complicaciones Posoperatorias/prevención & control , Complicaciones Posoperatorias/terapia , Estudios Prospectivos
13.
Catheter Cardiovasc Interv ; 94(1): E44-E53, 2019 07 01.
Artículo en Inglés | MEDLINE | ID: mdl-30549227

RESUMEN

OBJECTIVE: To compare procedural outcomes of transcatheter aortic valve implantation (TAVI) patients who were implanted with older versus newer generation valves. BACKGROUND: The current evidence base for improved safety of the newer commercially available TAVI valves is limited. METHODS: A retrospective analysis of the Israeli multicenter TAVI registry was performed. Patients were stratified by valve generation of four commercially available devices: Edwards Sapien (ESX) Edwards Sapien S3 (ES3), Medtronic CoreValve (MCV), and Medtronic Evolut R (MER). RESULTS: The cohort consisted of 737 patients with new generation valves (NGVs; ES3 n = 223; MER n = 514) and 1,869 with old generation valves (OGVs; MCV n = 1,181; ESX n = 688). Device success rates were significantly higher in NGV (97.5 versus 95.4%), with less post-procedural paravalvular leak (3 versus 5.8%), and valve mal-positioning (1.2 versus 3.4%); all P-values<0.05. There were no differences in rates of permanent pacemaker implantation, stroke or acute kidney injury (AKI) of any stage between the groups, although stage ≥2 AKI was more prevalent in NGV. After adjustment to significant differences in baseline patient and procedural characteristics, device success was higher (OR 1.86, 95% confidence interval (CI) 1.09-3.18, P = 0.023) and the 1-month safety outcome was significantly lower (OR 0.72, 95% CI 0.55-0.96, P = 0.025) for NGV. Device success was driven mainly by improved rates of PVL of ES3, while the safety outcome was mainly driven by improved rates of life-threatening bleeding and valve mal-positioning of MER. CONCLUSION: As compared to OGV, use of NGV for TAVI was associated with higher rates of device success and lower rates of adverse events.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Femenino , Humanos , Israel , Masculino , Seguridad del Paciente , Falla de Prótesis , Estudios Retrospectivos , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento
14.
Isr Med Assoc J ; 21(12): 790-795, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31814341

RESUMEN

BACKGROUND: Patients with right bundle branch block (RBBB) prior to transcatheter aortic valve implantation (TAVI) are at high risk for immediate post-procedural heart block and long-term mortality when discharged without a pacemaker. OBJECTIVES: To test whether prophylactic permanent pacemaker implantation (PPI) is beneficial. METHODS: Of 795 consecutive patients who underwent TAVI, 90 patients had baseline RBBB. We compared characteristics and outcomes of the prophylactic PPI with post-TAVI PPI. Need for pacing was defined as  greater than 1% ventricular pacing. RESULTS: Forty patients with RBBB received a prophylactic PPI (group 1), and in 50 the decision was based on standard post-procedural indications (group 2). There were no significant differences in clinical baseline characteristics. One patient developed a tamponade after a PPI post-TAVI. A trend toward shorter hospitalization duration in group 1 patients was observed (P = 0.06). On long-term follow-up of 848 ± 56 days, no differences were found in overall survival (P = 0.77), the composite event-free survival of both mortality and hospitalizations (P = 0.66), or mortality and syncope (P = 0.65). On multivariate analysis, independent predictors of the need for pacing included baseline PR interval increase of 10ms (odds ratio [OR] 1.21 per 10 ms increment 95% confidence interval [95%CI] 1.02-1.44, P = 0.028), and the use of new generation valves (OR 3.92, 95%CI 1.23-12.46, P = 0.023). CONCLUSIONS: In patients with baseline pre-TAVI RBBB, no outcome differences were found with prophylactic PPI. On multivariate analysis, predictors of the need for pacing included baseline long PR interval, and the use of newer generation valves.


Asunto(s)
Bloqueo de Rama , Estimulación Cardíaca Artificial , Complicaciones Posoperatorias , Cuidados Preoperatorios/métodos , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/epidemiología , Estenosis de la Válvula Aórtica/cirugía , Bloqueo de Rama/diagnóstico , Bloqueo de Rama/terapia , Estimulación Cardíaca Artificial/métodos , Estimulación Cardíaca Artificial/estadística & datos numéricos , Femenino , Humanos , Israel/epidemiología , Tiempo de Internación/estadística & datos numéricos , Masculino , Mortalidad , Evaluación de Procesos y Resultados en Atención de Salud , Marcapaso Artificial , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/prevención & control , Utilización de Procedimientos y Técnicas/estadística & datos numéricos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos
15.
J Electrocardiol ; 51(3): 481-486, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29395105

RESUMEN

OBJECTIVES: To predict the QT interval in the presence of normal QRS for patients with left bundle branch block (LBBB). BACKGROUND: There is no acceptable method for simple and reliable QT correction for patients with bundle branch block (BBB). METHODS: We measured the QT interval in patients with new onset LBBB who had a recent electrocardiogram with narrow QRS for comparison. 48 patients who developed in-hospital LBBB were studied. Patients who had similar heart rate before and after LBBB were included. We used linear regression, the Bogossian method, and our new fixed QRS replacement method to evaluate the most reliable correction method. RESULTS: JTc (QTc-QRS) interval was preserved before and after LBBB (328.9 ±â€¯25.4 ms before LBBB vs. 327.3 ms post LBBB (p = 0.550). Mean predicted preLBBB QTc difference was 1.3 ms, -21.3 ms and 1.6 ms for the three methods respectively (p < 0.001 for Bogossian comparison with the other methods). Coefficients of correlation (R) between actual preLBBB QTc with predicted preLBBB QTc were 0.707, 0.683 and 0.665 respectively (p > 0.3 for R comparisons between all methods). The average absolute difference in preLBBB QTc was 15.5 ms and 16.7 ms for the regression and fixed-gender methods (p value between the two = 0.321) and 25.5 ms for the Bogossian method, which was found to be significantly underperforming. CONCLUSIONS: In patients with LBBB, replacing of the QRS duration after deriving the QTc interval with a fixed value of 88 ms for female and 95 ms for male provides a simple and reliable method for predicting the QTc before the development of LBBB.


Asunto(s)
Bloqueo de Rama/fisiopatología , Electrocardiografía , Anciano , Femenino , Frecuencia Cardíaca/fisiología , Humanos , Masculino , Valor Predictivo de las Pruebas , Reemplazo de la Válvula Aórtica Transcatéter
16.
Cardiology ; 137(1): 36-42, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-27988518

RESUMEN

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is frequently associated with the development of conduction abnormalities. We assessed the effect of conduction abnormalities on diastolic function following TAVI. METHODS: In total, 101 consecutive post-TAVI patients were included, each with echocardiographic follow-up at 1 and 6 months. Diastolic properties were correlated with the occurrence of a long PR interval and wide QRS, and their change from baseline. The measured diastolic parameters included E/A ratio, E wave deceleration time, E wave to e' ratio, left atrial (LA) volume, and systolic pulmonary artery pressure (SPAP). The clinical outcome was all-cause mortality. RESULTS: Overall, TAVI was associated with a consistent decrease in SPAP at the 1- and 6-month follow-up. LA volumes were increased at 1 month post-TAVI in patients with a wide compared to normal QRS (p = 0.03) and at 6 months in patients with a normal compared to prolonged PR (p = 0.03). PR prolongation above 40 ms was associated with lower SPAP at the 1- but not 6-month follow-up. Survival was not influenced by conduction abnormalities. CONCLUSIONS: TAVI is associated with a reduction in SPAP. A postprocedural wide QRS and normal PR interval may unfavorably influence the left-sided filling performance, resulting in an increased LA volume. Other diastolic parameters, as well as survival, are not significantly affected by postprocedural conduction abnormalities.


Asunto(s)
Sistema de Conducción Cardíaco/fisiopatología , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Disfunción Ventricular Izquierda/diagnóstico por imagen , Disfunción Ventricular Izquierda/fisiopatología , Anciano , Anciano de 80 o más Años , Diástole , Ecocardiografía , Electrocardiografía , Femenino , Estudios de Seguimiento , Humanos , Israel , Masculino , Presión Esfenoidal Pulmonar , Centros de Atención Terciaria , Factores de Tiempo , Resultado del Tratamiento
17.
BMC Cardiovasc Disord ; 17(1): 137, 2017 05 26.
Artículo en Inglés | MEDLINE | ID: mdl-28549463

RESUMEN

BACKGROUND: Most patients undergoing Transcatheter aortic valve implantation (TAVR) are elderly with significant co-morbidities and there is limited information available regarding factors that influence length of stay (LOS) post-procedure. The aim of this study was to identify the patient, and procedural factors that affect post-TAVR LOS using a contemporary multinational registry. METHODS: We conducted a retrospective cohort study, with patients recruited from three high volume tertiary institutions. The primary outcome was the LOS post-TAVR procedure. We examined patient and procedural factors in a cause-specific Cox multivariable regression model to elucidate their effect on LOS, accounting for the competing risk of post-procedural death. Hazard ratios (HR) greater than 1 indicate a shorter LOS, while HRs less than 1 indicate a longer LOS. RESULTS: The cohort consisted of 809 patients. Patient factors associated with longer LOS were older age, prior atrial fibrillation, and greater patient urgency. Patient factors associated with shorter LOS were lower NYHA class, higher ejection fraction and higher mean aortic valve gradients. Procedural characteristics associated with shorter LOS were conscious sedation (HR = 1.19, 95% CI 1.06-1.35, p = 0.004). Transapical access was associated with prolonged LOS (HR = 0.49, 95% CI 0.41-0.58, p < 0.001). CONCLUSION: This multicenter study identified potentially modifiable patient and procedural factors associated with a prolonged LOS. Future research is needed to determine if interventions focused on these factors will translate to a shorter LOS.


Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Tiempo de Internación , Reemplazo de la Válvula Aórtica Transcatéter , Anestesia General , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Distribución de Chi-Cuadrado , Comorbilidad , Sedación Consciente , Hemodinámica , Mortalidad Hospitalaria , Hospitales de Alto Volumen , Humanos , Israel , Análisis Multivariante , Oportunidad Relativa , Ontario , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de Riesgo , Centros de Atención Terciaria , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del Tratamiento
18.
Isr Med Assoc J ; 19(3): 156-159, 2017 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-28457092

RESUMEN

BACKGROUND: Transcatheter tricuspid valve-in-valve implantation (TVIV) is an attractive yet under-explored alternative to redo valve surgery. OBJECTIVES: To report the multicenter TVIV experience in Israel. METHODS: We approached multiple centers and collected data regarding seven TVIV cases. RESULTS: The study group comprised seven participants: five females and two males, with a mean age of 63 ± 12 years and EuroSCORE-II 13.6 ± 3.3%. Follow-up ranged from 3 to 21 months (mean 8 ± 6 months). All presented with advanced heart failure. The indication for valve intervention was a predominant tricuspid stenosis in three patients, significant tricuspid regurgitation in one and a mixture in three. Six procedures were conducted via a transfemoral approach and one by transatrial access. The Edwards SAPIENTM XT valve was used in four cases and the SAPIENTM 3 in three. Without pre-stenting/rapid pacing, all participants underwent successful valve implantation. Mean transvalvular gradient decreased from 11 ± 3 mmHg to 6 ± 3 mmHg (P = 0.003) and regurgitation decreased from moderate/severe (in four cases) to none/trace (in six of the seven cases). One patient remained severely symptomatic and died 3.5 months after the implantation. All others achieved a functional capacity improvement and amelioration of symptoms soon after the implantation, which persisted during follow-up. CONCLUSIONS: TVIV may be a safe and effective strategy to treat carefully selected patients with degenerated bioprosthetic tricuspid valve at high operative risk.


Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas/métodos , Catéteres Cardíacos , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Válvula Tricúspide , Insuficiencia de la Válvula Tricúspide/cirugía , Estenosis de la Válvula Tricúspide/cirugía
19.
Catheter Cardiovasc Interv ; 87(6): 1156-63, 2016 May.
Artículo en Inglés | MEDLINE | ID: mdl-26526673

RESUMEN

OBJECTIVES: To investigate the impact of preprocedural left ventricular (LV) diastolic function on outcomes of patients with postprocedural aortic regurgitation (ARpost ) following transcatheter aortic valve replacement (TAVR). BACKGROUND: The predictors and mechanisms of the increased mortality in patients with ARpost are inadequately defined. METHODS: Baseline clinical and echocardiographic variables from a prospective TAVR registry were analyzed. Preprocedural correlates of late outcomes (all-cause mortality and the composite of mortality, stroke, heart failure, and new-onset atrial fibrillation) were examined according to the presence and severity of ARpost . RESULTS: Of the 418 patients undergoing TAVR, ARpost was present in 212 (51%): mild 36%, moderate-severe 15%. Mean follow-up was 909 ± 489 days. All-cause mortality and composite endpoint rates were significantly increased in patients with moderate-severe ARpost compared with patients with either none or only mild ARpost (38, 22, 21%, P = 0.02; and, 56, 35, 40%, P = 0.01; respectively). Moderate-severe (though not mild) ARpost was independently associated with mortality and the composite endpoint (HR = 1.93 [95%CI 1.15-3.14], P = 0.01; HR = 1.85 [95%CI 1.22-2.77], P = 0.004], respectively). By multivariate analysis, preprocedural LV deceleration time (DT) < 160 ms was independently associated with the risk of all-cause mortality and the composite endpoint among patients with mild AR (HR = 1.74 [95%CI 1.14-2.60], P = 0.01; and, HR = 1.73 [95%CI 1.23-2.41], P = 0.002, respectively) and moderate-severe ARpost (HR = 1.81 [95%CI 1.28-2.51], P < 0.001; HR = 1.86 [95%CI 0.22-2.80], P = 0.004, respectively). CONCLUSIONS: Preprocedural impairment of LV filling, reflected by short DT, portends an adverse prognosis in TAVR patients who develop ARpost independently of other clinical and echocardiocardigraphic measures including AS severity and systolic LV function. © 2015 Wiley Periodicals, Inc.


Asunto(s)
Insuficiencia de la Válvula Aórtica/etiología , Estenosis de la Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Función Ventricular Izquierda/fisiología , Anciano de 80 o más Años , Angiografía , Insuficiencia de la Válvula Aórtica/mortalidad , Insuficiencia de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/fisiopatología , Diástole , Ecocardiografía Doppler , Femenino , Prótesis Valvulares Cardíacas , Humanos , Israel/epidemiología , Masculino , Periodo Preoperatorio , Pronóstico , Estudios Prospectivos , Factores de Riesgo , Índice de Severidad de la Enfermedad , Tasa de Supervivencia/tendencias
20.
Cardiology ; 134(2): 101-6, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-26928427

RESUMEN

OBJECTIVES: Previous studies investigating the prognostic value of HbA1c in patients undergoing coronary angiography reported a mixed pattern of results. Therefore, we aimed to better define the prognostic power of HbA1c among coronary catheterized patients. METHODS: Patients undergoing coronary angiography (n = 3,749) were divided into four groups according to HbA1c levels (<5, 5-6, 6-7 and >7%). Cox regression models assessed long-term mortality after adjusting for multiple covariates. RESULTS: Baseline clinical profiles differed in HbA1c groups, with a higher prevalence of comorbidities in the groups with higher HbA1c levels. Median follow-up was 1,745 days (interquartile range 1,007-2,171). A J-shaped association curve was observed between HbA1c levels and all-cause mortality rates, with patients in the lowest and highest HbA1c groups suffering from significantly higher mortality rates compared to in-between groups (hazard ratio 1.9, 95% CI 1.32-2.74, p = 0.001, and hazard ratio 1.58, 95% CI 1.29-1.95, p < 0.001, for the lowest and highest HbA1c groups, respectively). This association persisted after adjustment for anemia, nutritional status, renal function, cardiovascular risk factors and inflammatory biomarkers. CONCLUSIONS: HbA1c levels <5 or >7% are predictors of all-cause mortality in patients undergoing coronary angiography.


Asunto(s)
Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Hemoglobina Glucada/análisis , Anciano , Biomarcadores/sangre , Causas de Muerte , Comorbilidad , Femenino , Humanos , Israel , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Análisis Multivariante , Pronóstico , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Factores de Riesgo , Factores de Tiempo
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