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OBJECTIVES: Transcatheter aortic valve implantation (TAVI) using balloon-expandable (BE) transcatheter heart valves (THV) in aortic annuli above 29 mm includes particular procedural steps, mainly involving overfilling of the deployment balloon. Data on overfilling strategies in clinical daily practice is scarce. We herein aimed for a retrospective description of utilized overfilling strategies in those patients. METHODS: Between January 2016 and December 2022, 45 patients (100% male, 76.9 ± 6.1 years) received TAVI in aortic annuli above 29 mm using a BE THV. Overfilling volumina of the deployment balloon were left to operators' discretion. Clinical and multislice computed tomography data were retrospectively collected. Clinical endpoints were adjudicated in accordance with the updated standardized VARC-3 definitions. RESULTS: Profound overfilling (+4/5 mL) was used in patients with a mild calcium burden (Ë750 mm³) even in aortic annuli of 29.0-30.0 mm. Nominal/slight overfilling (+1 mL) was used in aortic annuli up to 32.5 mm but an intermediate to severe calcific burden (>750-3200 mm³). Accordingly, a low calcification group (Ë750 mm³, n = 17) compared to a significant calcification group (≥750 mm³, n = 28), presented with higher overfilling volumina (2.1 ± 1.4 vs. 0.8 ± 1.0; p Ë 0.001), although aortic annulus diameter was not different (29.8 ± 0.8 vs. 29.9 ± 0.9 mm; p = 0.7). All-cause 30-day mortality was 0%. Device success was 97.8%. Transvalvular mean pressure gradient at discharge was 9.5 ± 3.6 mmHg. No case of PVL >mild was documented. CONCLUSION: Extent of overfilling of the deployment balloon largely depends on calcification burden in addition to aortic annulus diameter with significant and profound overfilling particularly in patients with a calcification burden of the aortic valve complex Ë750 mm³.
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Estenosis de la Válvula Aórtica , Calcinosis , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Masculino , Femenino , Estudios Retrospectivos , Resultado del Tratamiento , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Calcinosis/diagnóstico por imagen , Calcinosis/terapia , Diseño de PrótesisRESUMEN
BACKGROUND: Despite continuous improvements in transcatheter aortic valve implantation (TAVI), periprocedural strokes remain a devastating complication. Randomized controlled trials failed to demonstrate a reduction in clinically apparent strokes or mortality after TAVI due to cerebral embolic protection (CEP). To identify potential targets of CEP strategies during TAVI, we evaluated affected brain regions, and temporal patterns of stroke onset in a routine clinical sample. METHODS AND RESULTS: A total of 3,164 consecutive patients treated with TAVI from 2008 to 2019 at a single center were screened for cerebrovascular events. Affected cerebral regions were determined according to clinical symptoms and brain imaging. Rates of disabling stroke and non-disabling stroke at 30 days were 2.2% and 1.4%, respectively. The frequency of all strokes decreased from 5.0% to 3.0% over time (P = .012). Patients with impaired left-ventricular function (OR 2.19), increased CHA2DS2-VASc (OR 1.39) and moderate/severe spontaneous echo contrast (OR 3.60) had a higher stroke risk. Acute symptom onset occurred during TAVI (19.4%), within 24 hours (40.3%) or later (25.0%); 98.3% of strokes were of ischemic origin. In intraprocedural strokes, 53.2% of lesions were found in locations considered protected by current CEP devices, and 37.5% of patients with intraprocedural strokes were exclusively affected in these areas. Baseline or procedural parameters were not associated with embolic distribution patterns. CONCLUSIONS: Most strokes occurred early after TAVI - but not necessarily during the procedure - and affected multiple brain regions only partially protected by current CEP devices. Efficient prevention of cerebrovascular events may require strategies beyond the TAVI procedure to minimize stroke risk and additional randomized controlled trials will be required to clarify the role of CEP in efficient stroke prevention during TAVI.
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Estenosis de la Válvula Aórtica , Dispositivos de Protección Embólica , Implantación de Prótesis de Válvulas Cardíacas , Embolia Intracraneal , Accidente Cerebrovascular , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/cirugía , Encéfalo/diagnóstico por imagen , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Embolia Intracraneal/epidemiología , Embolia Intracraneal/etiología , Embolia Intracraneal/prevención & control , Factores de Riesgo , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: Compared to high gradient aortic stenosis (AS), patients with low-flow, low-gradient AS have higher mortality after transcatheter aortic valve replacement (TAVR), but distinct outcome predictors in this patient subset are yet to be determined. The present study investigated the prognostic impact of aortic valve calcification (AVC) in patients with low-flow, low-gradient AS undergoing TAVR. METHODS: This retrospective single-center analysis includes all patients undergoing TAVR for severe low-flow, low-gradient AS (nâ¯=â¯526), ie, low EF low gradient AS (LEF-LG AS; nâ¯=â¯290) and paradoxical low-flow, low-gradient AS (PLF-LG AS; nâ¯=â¯236), in whom AVC was quantified from contrast-enhanced multislice computed tomography images. AVCdensity was defined as calcium volume per annulus area. Patients were trichotomized according to sex-specific AVCdensity tertiles in both subgroups. All-cause mortality was assessed by Kaplan-Meier analyses and independent outcome predictors were determined by multivariable analyses. RESULTS: In both subgroups, patients with high AVCdensity had higher mean transvalvular gradients at baseline and higher rates of PVL after TAVR. High AVCdensity was associated with lowest 1- and 3-year mortality after TAVR in the LEF-LG AS but not in the PLF-LG AS group. According to multivariable analysis AVCdensity was independently associated with better survival in LEF-LG AS patients (HR 0.73 [0.60-0.88], Pâ¯=â¯.0011), but not in those with PLF-LG AS (HR 0.91 [0.73-1.14], Pâ¯=â¯.42). CONCLUSIONS: Quantification of AVC may not only be of diagnostic but also of prognostic value, as it facilitates the selection of LEF-LG AS patients with higher probability of beneficial outcome after TAVR.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/patología , Calcinosis/clasificación , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Calcinosis/diagnóstico por imagen , Calcinosis/patología , Calcinosis/fisiopatología , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Pronóstico , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Volumen SistólicoRESUMEN
With next-generation valves such as the ALLEGRA valve from NewValve Technologies (NVT), Hechingen Germany, there is a very likely treatment expansion for patients with aortic valve disease. Besides treatment of native valvular aortic stenosis with the ALLEGRA valve, the special implant mechanism seems to be an appealing concept for patients with degenerated surgical bioprostheses. We report the first case of a transfemoral implantation in small degenerated surgical bioprosthesis of a 76-year-old woman.
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Válvula Aórtica/cirugía , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas , Falla de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Diseño de Prótesis , Recuperación de la Función , Resultado del TratamientoRESUMEN
(1) Background: Transfemoral transcatheter aortic valve implantation (TAVI) has become the standard treatment for most patients with severe symptomatic aortic stenosis. Intravascular lithotripsy may facilitate transfemoral TAVI (IVL-TAVI) even in patients with severely calcified iliofemoral disease. We assessed technical aspects and clinical outcomes of this novel approach compared to alternative transaxillary access (TAX-TAVI). (2) Methods: IVL-TAVI was performed for severe iliofemoral calcifications precluding standard transfemoral access in 30 patients from 2019 to 2022 at a single academic heart center. IVL was performed as part of the TAVI procedure in all cases. Results were compared to a control group of 44 TAX-TAVI procedures performed for the same indication from 2016 to 2021. The safety outcome was a composite of all-cause death, stroke, access-related bleeding ≥ type 2 within 24 h and major vascular access site complications at 30 days. The efficacy outcome was defined as a technical success according to VARC-3. (3) Results: Median age was 78.2 [74.3, 82.6] years, 45.9% were female and mean STS-PROM was 3.6% [2.3, 6.0]. Iliofemoral calcifications were more severe in the IVL-TAVI vs. TAX-TAVI groups (lesion length: 63.0 mm [48.6, 80.3] vs. 48.5 mm [33.1, 68.8]; p = 0.043, severe calcification at target lesion: 90.0% vs. 68.2%; p = 0.047, and median arc calcification 360.0° [297.5, 360.0] vs. 360.0° [180.0, 360.0]; p = 0.033). Technical success was achieved in 93.3% vs. 81.8% (p = 0.187) in IVL- and TAX-TAVI and the safety outcome occurred in 10.0% vs. 31.8% in IVL- and TAX-TAVI (p = 0.047), respectively. (4) Conclusions: IVL-assisted transfemoral TAVI was feasible and safe with favorable outcomes compared to TAX-TAVI. IVL may further expand the number of patients eligible for transfemoral TAVI and may help overcome limitations of an alternative access.
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BACKGROUND: Beneficial results of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) in patients at all risk strata have led to substantial changes in guideline recommendations for valvular heart disease. AIM: To examine influence of these guideline changes on a real-world TAVI cohort, we evaluated how risk profiles and outcomes of TAVI patients developed in our single-center patient cohort over a period of 12 years. METHODS: Baseline, procedural and 30-day outcome parameters of TAVI patients were retrospectively compared between three time periods (period 1: 2008-2012, period 2: 2013-2017, period 3: 2018-2020). RESULTS: Between 03/2008 and 12/2020, a total of 3678 patients underwent TAVI at our center. The median age was 81.1 years (25th, 75th percentile: 76.7, 84.9) with no significant change over time. The EuroSCORE II showed a continuous and significant decline from 5.3% (3.3, 8.6) in period 1 to 2.8% (1.7, 5.0) in period 3 (p < 0.001). Furthermore, rates of permanent pacemaker implantation, acute kidney injury, and paravalvular leakage ≥ moderate continuously declined over time. Accordingly, the 30-day mortality fell from 9.3% in period 1 to 4.3% in period 3 (p < 0.001). CONCLUSION: Despite substantial guideline alterations, median patient age remained largely unchanged in our TAVI cohort over the past 12 years. Therefore, increased age still appears to be the main reason to choose TAVI over SAVR. However, risk profiles declined substantially. Significant improvements in early outcomes suggest favorable influence of less invasive access routes, improved device platforms and growing user experience.
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Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Anciano de 80 o más Años , Niño , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/etiología , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodosRESUMEN
Background: Valve-in-valve (ViV) transfemoral transcatheter aortic valve implantation (TAVI) for failing aortic surgical bioprostheses or transcatheter heart valves (THV) has demonstrated a reasonable clinical and hemodynamic efficacy. Traditionally, self-expanding (SE) supra-annular THV are considered to result in superior hemodynamics compared with balloon-expandable intra-annular THV after ViV. However, so far no data are found on latest-generation intra-annular SE THV for aortic ViV procedures which might be superior with regard to coronary access or subsequent valve reintervention. Aim: We herein aim to evaluate a latest-generation SE intra-annular THV for aortic ViV procedures. Materials and methods: Between May 2022 and November 2022, five consecutive patients (4/5 female with mean age of 76.2 years and mean Society of Thoracic Surgeons predicted risk of mortality score of 2.9%) received ViV TAVI using the Navitor system (Abbott, Chicago, IL, USA) for treatment of failing surgical bioprostheses or THV. Data were retrospectively analyzed according to updated Valve Academic Research Consortium 3 (VARC-3) definitions. Results: At 30 days, absence of mortality and VARC-3 adjudicated clinical endpoints were documented. Echocardiography at 30 days revealed complete absence of paravalvular leakage and single-digit mean transvalvular gradients (mean of 6.0â mmHg) in all patients. Conclusion: The investigated intra-annular SE THV results in excellent 30-day outcomes for aortic ViV procedures for failing surgical bioprostheses or THV. Despite the intra-annular design, hemodynamic results were excellent, even in small bioprostheses. Ease of use of this valve platform is reflected by only two cycles of resheathing in five ViV procedures with hemodynamic stability during all steps of valve deployment.
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Aortic valve disease, especially aortic valve stenosis, is one of the most common acquired valve diseases and is associated with increased mortality and morbidity. Due to the rising age of the population, the prevalence of aortic valve stenosis has increased sharply in recent years. For many years, surgical aortic valve replacement was the only available therapy beside the conservative approach. With the implantation of the first catheter-based valve prosthesis in 2002, the era of transcatheter aortic valve implantation began. While this therapy was initially limited to inoperable and high-risk patients, the indication has been increasingly extended to younger patients with lower surgical risk over the past years. However, choosing the optimal therapy modality and determining the ideal timing of treatment can often be challenging in clinical practice. The aim of this article is to provide an overview of the different therapy modalities, the decision-making process and current therapy guidelines.
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Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: Patients with chronic hemodialysis due to end-stage renal disease (ESRD) or severely impaired kidney function (CKD) constitute a relevant share of patients undergoing trans-catheter aortic valve implantation (TAVI). However, data on specific challenges and outcomes remain limited. AIM: We aimed to characterize this patient population, evaluate clinical results and assess the significance of calcification patterns. METHODS: This retrospective single-center analysis evaluated 2,712 TAVI procedures (2012-2019) according to baseline renal function: GFR < 30 ml/min/1.73m2 (CKD; n = 210), chronic hemodialysis (ESRD; n = 119) and control (CTRL; n = 2383). Valvular and vascular calcification patterns were assessed from contrast-enhanced multi-detector computed tomography. Outcomes were evaluated in accordance with the VARC-2 definitions. RESULTS: Operative risk was higher in ESRD and CKD vs. CTRL (STS-score 8.4% and 7.6% vs. 3.9%, p < 0.001) and patients with ESRD had more severe vascular calcifications (49.1% vs. 33.9% and 29.0%, p < 0.01). Immediate procedural results were similar but non-procedure-related major/life-threatening bleeding was higher in ESRD and CKD (5.0% and 5.3% vs. 1.6%, p < 0.01). 3-year survival was impaired in patients with ESRD and CKD (33.3% and 35.3% vs. 65.4%, p < 0.001). Multivariable analysis identified ESRD (HR 1.60), CKD (HR 1.79) and vascular calcifications (HR 1.29) as predictors for 3-year and vascular calcifications (HR 1.51) for 30-day mortality. CONCLUSION: Patients with ESRD and CKD constitute a vulnerable patient group with extensive vascular calcifications. Immediate procedural results were largely unaffected by renal impairment, yielding TAVI a particularly valuable treatment option in these high-risk operative patients. Mid-term survival was determined by underlying renal disease, cardiovascular comorbidities, and vascular calcifications as a novel risk marker.
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Estenosis de la Válvula Aórtica , Fallo Renal Crónico , Insuficiencia Renal Crónica , Reemplazo de la Válvula Aórtica Transcatéter , Calcificación Vascular , Humanos , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Estudios Retrospectivos , Resultado del Tratamiento , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Fallo Renal Crónico/complicaciones , Fallo Renal Crónico/diagnóstico , Fallo Renal Crónico/epidemiología , Calcificación Vascular/diagnóstico por imagen , Calcificación Vascular/cirugía , Factores de RiesgoRESUMEN
As valve-in-valve (ViV) transcatheter aortic valve implantation is still an evolving method, we evaluated the development of early and midterm outcomes after ViV and conventional redo-surgical aortic valve replacement (SAVR) over the past 2 decades. In-hospital databases were retrospectively screened for patients ≥60 years treated for failing bioprosthetic aortic valves at our center. Clinical and follow-up characteristics were compared between patients who underwent ViV or redo-SAVR according to valve academic research consortium-2 (VARC-2) definitions. The comparison of outcome parameters was adjusted for baseline differences between groups. Between June 2002 and April 2020, 209 patients with ViV and 65 redo-SAVR patients met inclusion criteria. No significant differences were found in 30 days (ViV 3.8%, SAVR 3.1%, p = 0.778) or 6-month mortality (ViV 14.0%, SAVR 7.5%, p = 0.283). As patients with ViV less frequently experienced acute kidney injury (stage II or III) and life-threatening bleeding, they more frequently reached the 30-day VARC-2 combined safety end point (79.2% vs 61.5%, odds ratio [OR] 2.540, p = 0.023). Patients with ViV less frequently reached clinical efficacy (68.3% vs 84.6%, OR 0.408, p = 0.041) and device success (79.9% vs 92.3%, OR 0.311, p = 0.040) end points, because of higher frequency of postprocedural transvalvular gradients >20 mm Hg. However, over the past decade, VARC-2 clinical efficacy and device success rates continuously increased in ViV cases. In conclusion, ViV and SAVR were associated with similar acute mortality and different beneficial and adverse outcome profiles in this single-center cohort. Results after ViV procedures have continuously improved over the past years.
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Estenosis de la Válvula Aórtica , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/etiología , Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Reoperación , Estudios Retrospectivos , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: Left ventricular outflow tract (LVOT) calcification is known to be associated with adverse outcomes after transcatheter aortic valve implantation (TAVI) in patients receiving first-generation transcatheter heart valves (THV). AIMS: The aim of the present study was to assess the prevalence of LVOT calcification as well as its impact on outcomes in a contemporary TAVI patient cohort. METHODS: This retrospective single-centre analysis includes 1,207 patients who underwent transfemoral TAVI between 2012 and 2018 and in whom adequate contrast-enhanced multislice computed tomgraphy (MSCT) imaging for quantification of LVOT calcification was available. RESULTS: Significant LVOT calcification, defined as >10 mm3, was present in 37.4% (n=451) of the patient cohort. After applying propensity score matching there was no difference between patients without (w/o; n=358) and with (w; n=358) significant LVOT calcification with respect to baseline clinical characteristics. At 30 days, the composite of all-cause mortality and non-disabling/disabling stroke occurred more often in patients w LVOT calcification compared to those w/o (4.6 vs 10.1%, p=0.008). Moreover, the composite VARC-3 endpoint of device success at 30 days was in favour of patients w/o LVOT calcification (82.2% vs 73.4%, p=0.007). According to Kaplan-Meier analysis, all-cause mortality one year after TAVI was higher in patients w vs w/o LVOT calcification (12.9 vs 21.4 %, p=0.004). CONCLUSIONS: In patients undergoing TAVI, the presence of significant LVOT calcification is common and associated with worse short-term clinical and functional outcomes as well as higher one-year mortality rates compared to patients w/o LVOT calcification.
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Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Calcinosis/complicaciones , Prótesis Valvulares Cardíacas/efectos adversos , Humanos , Tomografía Computarizada Multidetector , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
OBJECTIVE: To evaluate whether the serum C-reactive protein to albumin ratio (CAR) could be used for risk stratification of patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). PATIENTS AND METHODS: Frailty is a predictor of poor outcomes in patients undergoing AS interventions. The CAR reflects key components of frailty (systemic inflammation and nutrition) and could potentially be implemented into assessment and management strategies for patients with AS. From March 1, 2010, through February 29, 2020, 1836 patients were prospectively enrolled in an observational TAVR database. Patients (prospective development cohort, n=763) were grouped into CAR quartiles to compare the upper quartile (CAR Q4) with the lower quartiles (CAR Q1-3). Primary end point was all-cause mortality. Results were verified in an independent retrospective cohort (n=1403). RESULTS: The CAR Q4 had a higher prevalence of impaired left ventricular function, atrial fibrillation, diabetes, and cerebrovascular disease and a higher median logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) vs CAR Q1-3. After median follow-up of 15.0 months, all-cause mortality was significantly higher in CAR Q4 vs CAR Q1-3 (P<.001). In multivariable analyses, risk factors for all-cause mortality were CAR Q4 (>0.1632; hazard ratio, 1.45; 95% confidence interval, 1.05 to 2.00; P=.03), N-terminal pro-B-type natriuretic peptide Q4 (>3230 pg/mL [to convert to ng/L, multiply by 1), high-sensitivity troponin T Q4 (>0.0395 ng/mL [to convert to µg/L, multiply by 1]), above-median logistic EuroSCORE (16.1%), myocardial infarction, Acute Kidney Injury Network stage 3, and life-threatening bleeding. CONCLUSION: Elevated CAR was associated with increased risk of all-cause mortality in patients undergoing transfemoral TAVR. The CAR, a simple, objective tool to assess frailty, could be incorporated into assessing patients with AS being considered for TAVR.
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Estenosis de la Válvula Aórtica , Fragilidad , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/cirugía , Proteína C-Reactiva , Humanos , Estudios Prospectivos , Estudios Retrospectivos , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: Heyde syndrome (HS) is known as the association of severe aortic stenosis (AS) and recurrent gastrointestinal bleeding (GIB) from angiodysplasia. Data on the prevalence of HS and results after TAVI remain scarce. METHODS: 2548 consecutive patients who underwent TAVI for the treatment of AS from 2008 to 2017 were evaluated for a history of GIB and the presence of HS. The diagnosis of HS was defined as a clinical triad of severe AS, a history of recurrent GIB, and an endoscopic diagnosis of angiodysplasia. These patients (Heyde) were followed to investigate clinical outcomes, bleeding complications and the recurrence of GIB and were compared to patients with GIB unrelated to HS (Non-Heyde). RESULTS: A history of GIB prior to TAVI was detected in 190 patients (7.5%). Among them, 47 patients were diagnosed with HS (1.8%). Heyde patients required blood transfusions more frequently compared to Non-Heyde patients during index hospitalization (50.0% vs. 31.9%, p = 0.03). Recurrent GIB was detected in 39.8% of Heyde compared to 21.2% of Non-Heyde patients one year after TAVI (p = 0.03). In patients diagnosed with HS and recurrent GIB after TAVI, the rate of residual ≥ mild paravalvular leakage (PVL) was higher compared to those without recurrent bleeding (73.3% vs. 38.1%, p = 0.05). CONCLUSION: A relevant number of patients undergoing TAVI were diagnosed with HS. Recurrent GIB was detected in a significant number of Heyde patients during follow-up. A possible association with residual PVL requires further investigation to improve treatment options and outcomes in patients with HS.
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Angiodisplasia/epidemiología , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Hemorragia Gastrointestinal/epidemiología , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano , Anciano de 80 o más Años , Angiodisplasia/complicaciones , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/complicaciones , Femenino , Fluoroscopía , Estudios de Seguimiento , Hemorragia Gastrointestinal/complicaciones , Alemania/epidemiología , Humanos , Masculino , Prevalencia , Estudios Retrospectivos , Síndrome , Resultado del TratamientoRESUMEN
OBJECTIVES: Due to high rates of transcatheter mitral valve replacement (TMVR) screening failure, a substantial proportion of patients with severe mitral regurgitation (MR) remains on optimal medical treatment (OMT) only. Data on outcomes of these patients ineligible for mitral interventions are scarce. This study aimed to assess characteristics and outcomes of severe MR patients treated medically following TMVR screening failure. METHODS: From 2016-2020, a total of 111 patients with severe MR underwent screening for TMVR. Screening failure occurred in 66 cases. Among these, 30 patients were treated with OMT only. Characteristics of these patients were analyzed, Kaplan-Meier estimates calculated, and univariate regression analysis performed. Median follow-up time was 2.26 years (95% confidence interval, 1.24-3.25). RESULTS: Anatomical reasons for screening failure in the study cohort (n = 30) were left ventricular (LV) restraints, risk of LV outflow tract obstruction, mitral annulus calcification, and sizing issues. Median ejection fraction was 56.0% (interquartile range, 38.8%-60.0%). Concomitant tricuspid regurgitation and severe pulmonary hypertension were present in 36.7% and 46.2%, respectively. Intercommissural diameters ranged from 22.5-52.0 mm. Mortality was 23.6% after 6 months and 35.7% after 1 year. Factors associated with mortality were female sex, MR severity, ischemic MR, high N-terminal pro-brain natriuretic peptide levels, and small annulus diameters. CONCLUSIONS: Despite growing experience with TMVR, the subset of MR patients anatomically eligible for TMVR is small and many patients are treated medically. Mortality in these patients remains high, underlining an unmet need for adequate therapeutic alternatives. TMVR devices adapting to broader annular size ranges with smaller ventricular profiles might fill this gap.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Cateterismo Cardíaco , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico , Insuficiencia de la Válvula Mitral/cirugía , Resultado del TratamientoRESUMEN
OBJECTIVES: This study aimed to assess the clinical outcome of the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary obstruction (BASILICA) technique in a single-center patient cohort considered at high or prohibitive risk of transcatheter aortic valve implantation (TAVI)-induced coronary obstruction. METHODS: Between October 2019 and January 2021, a total of 15 consecutive patients (age 81.0 [78.1, 84.4] years; 53.3% female; EuroSCORE II 10.6 [6.3, 14.8] %) underwent BASILICA procedure prior to TAVI at our institution. Indications for TAVI were degeneration of stented (n = 12, 80.0%) or stentless (n = 1, 6.7%) bioprosthetic aortic valves, or calcific stenosis of native aortic valves (n = 2, 13.3%), respectively. Individual risk of TAVI-induced coronary obstruction was assessed by pre-procedural computed tomography analysis. Procedural and 30-day outcomes were documented in accordance with Valve Academic Research Consortium (VARC)-2 criteria. RESULTS: BASILICA was attempted for single left coronary cusp in 12 patients (80.0%), for single right coronary cusp in 2 patients (13.3%), and for both cusps in 1 patient (6.7%), respectively. The procedure was feasible in 13 patients (86.7%) resulting in effective prevention of coronary obstruction, whilst TAVI was performed without prior successful bioprosthetic leaflet laceration in two patients (13.3%). In one of these patients (6.7%), additional chimney stenting immediately after TAVI was performed. No all-cause deaths or strokes were documented after 30 days. CONCLUSION: The BASILICA technique appears to be a feasible, safe and effective concept to avoid iatrogenic coronary artery obstruction during TAVI in both native and bioprosthetic valves of patients at high or prohibitive risk. ClinicalTrials.gov Identifier: NCT04227002 (Hamburg AoRtic Valve cOhoRt).
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Bioprótesis/efectos adversos , Oclusión Coronaria/prevención & control , Prótesis Valvulares Cardíacas/efectos adversos , Enfermedad Iatrogénica/prevención & control , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Angiografía Coronaria , Oclusión Coronaria/diagnóstico , Vasos Coronarios/diagnóstico por imagen , Ecocardiografía , Femenino , Fluoroscopía , Estudios de Seguimiento , Humanos , Masculino , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/prevención & control , Diseño de Prótesis , Estudios Retrospectivos , Tomografía Computarizada por Rayos XRESUMEN
BACKGROUND: A small aortic annulus is associated with increased risk of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI). Whether specific transcatheter heart valve (THV) designs yield superior hemodynamic performance in these small anatomies remains unclear. METHODS: Data from 8411 consecutive patients treated with TAVI from May 2012 to April 2019 at four German centers were retrospectively evaluated. A small aortic annulus was defined as multidetector computed tomography-derived annulus area < 400 mm2. TAVI was performed with a balloon-expanding intra-annular (Sapien-3, n = 288), self-expanding intra-annular (Portico, n = 110), self-expanding supra-annular (Evolut, n = 179 and Acurate-Neo, n = 428) and mechanically expanding infra-annular (Lotus, n = 64) THV according to local practice. PPM was defined as indexed effective orifice area ≤ 0.85cm2/m2. RESULTS: A small annulus was found in 1069 (12.7%) patients. PPM was detected in 38.3% overall with a higher prevalence after implantation of a balloon-expanding intra-annular or mechanically expanding infra-annular THV compared to self-expanding intra- and supra-annular THV. Multivariable analysis linked self-expanding THV (Evolut: Odds ratio [OR] 0.341, Acurate-Neo: OR 0.436, Portico: OR 0.291), postdilatation (OR 0.648) and age (OR 0.968) to lower rates of PPM, while aortic valve calcification was associated with an increased risk (OR 1.001). Paravalvular regurgitation > mild was more frequent after TAVI with self-expanding THV (p = 0.04). CONCLUSION: In this large contemporary multicenter patient population, a substantial number of patients with a small aortic anatomy were left with PPM after TAVI. Self-expanding supra- and intra-annular THV demonstrated superior hemodynamics in these patients at risk, however at the cost of higher rates of residual paravalvular regurgitation.
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/patología , Calcinosis/cirugía , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico , Calcinosis/diagnóstico , Femenino , Fluoroscopía , Humanos , Masculino , Tomografía Computarizada Multidetector , Diseño de Prótesis , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
AIMS: The relevance of spontaneous echo contrast (SEC) and left atrial appendage thrombus (LAAT) in patients undergoing transcatheter aortic valve implantation (TAVI) remains unclear. In this study, we aimed to assess the prevalence of SEC and LAAT and evaluate the impact on periprocedural outcome after TAVI. METHODS AND RESULTS: A total of 2,549 consecutive patients underwent TAVI between 2008 and 2017. After exclusion of cases with insufficient imaging, concomitant procedures or severe intraprocedural complications, 1,558 cases were analysed. Three groups were defined according to (pre)thrombotic formations - moderate or severe SEC (n=89), LAAT (n=53), and reference (n=1,416). The primary outcome was disabling ischaemic stroke within 24 hours. The prevalence was 4.4% for LAAT and 5.4% for moderate/severe SEC. The primary outcome occurred more frequently in patients with moderate/severe SEC (6.8%) compared to the reference (2.1%) and LAAT (1.9%) groups (p=0.020). SEC was identified as an independent risk factor for the primary outcome (OR 3.54 [95% CI: 1.30-9.61], p=0.013). LAAT was associated with an impaired unadjusted one-year survival (43.4%) compared to the SEC (27.3%) and reference groups (18.7%, p<0.001). CONCLUSIONS: SEC and LAAT were detected in a relevant number of patients undergoing TAVI. SEC may represent an important risk factor for intraprocedural stroke; increased mortality was observed in patients with LAAT.
Asunto(s)
Apéndice Atrial , Fibrilación Atrial , Isquemia Encefálica , Accidente Cerebrovascular , Trombosis , Reemplazo de la Válvula Aórtica Transcatéter , Apéndice Atrial/diagnóstico por imagen , Apéndice Atrial/cirugía , Ecocardiografía Transesofágica , Humanos , Factores de Riesgo , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Trombosis/diagnóstico por imagen , Trombosis/epidemiología , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversosRESUMEN
AIMS: The aim of this study was to assess the prognostic value of the H2 FPEF score in patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) and preserved left ventricular ejection fraction (EF). METHODS AND RESULTS: In this multicentre study, a total of 832 patients from two German high-volume centres, who received TAVI for severe AS and preserved EF (≥50%), were identified for calculation of the H2 FPEF score. Patients were dichotomized according to low (0-5 points; n = 570) and high (6-9 points; n = 262) H2 FPEF scores. Kaplan-Meier and Cox regression analyses were applied to assess the prognostic impact of the H2 FPEF score. We observed a decrease in stroke volume index (-2.04 mL/m2 /point) and mean transvalvular gradients (-1.14 mmHg/point) with increasing H2 FPEF score translating into a higher prevalence of paradoxical low-flow, low-gradient AS among patients with high H2 FPEF score. One year after TAVI, the rates of all-cause (low vs. high H2 FPEF score: 8.0% vs. 19.4%, P < 0.0001) and cardiovascular (CV) mortality (1.9% vs. 9.0%, P < 0.0001) as well as the rate of CV mortality or rehospitalization for congestive heart failure (6.4% vs. 23.2%, P < 0.0001) were higher in patients with high H2 FPEF score compared with those with low H2 FPEF score. After multivariable analysis, a high H2 FPEF score remained independently predictive of all-cause mortality [hazard ratio 1.59 (1.28-2.35), P = 0.018] and CV mortality or rehospitalization for congestive heart failure [hazard ratio 2.92 (1.65-5.15), P < 0.001]. Among the H2 FPEF score variables, atrial fibrillation, pulmonary hypertension, and elevated left ventricular filling pressure were the strongest outcome predictors. CONCLUSIONS: The H2 FPEF score serves as an independent predictor of adverse CV and heart failure outcome among TAVI patients with preserved EF. A high H2 FPEF score is associated with the presence of paradoxical low-flow, low-gradient AS, the HFpEF in patients with AS. By identifying patients in advanced stages of HFpEF, the H2 FPEF score might be useful as a risk prediction tool in patients with preserved EF scheduled for TAVI.
Asunto(s)
Estenosis de la Válvula Aórtica , Insuficiencia Cardíaca , Reemplazo de la Válvula Aórtica Transcatéter , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Insuficiencia Cardíaca/epidemiología , Humanos , Pronóstico , Volumen Sistólico , Función Ventricular IzquierdaRESUMEN
According to the Valve Academic Resortium, underweight is one parameter in the definition of frailty, which is associated with increased mortality after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). Aims of our study were (1) to examine the impact of underweight on mortality after TAVI and SAVR and (2) to determine the effect of intervention mode (TAVI vs SAVR) on mortality in underweight patients from the German Aortic Valve Registry. Overall, 35,109 patients treated with TAVI or SAVR were studied. Outcomes of underweight (body mass index [BMI] <20 kg/m2) TAVI and SAVR patients were compared using propensity score weighting. Prevalence of underweight was 5.7% in patients who underwent TAVI and 2.9% in patients who underwent SAVR. Underweight patients had significantly increased mortality rates for both treatment strategies compared with normal weight patients (BMI 20 to 30 kg/m2). Comparing underweight TAVI and SAVR-patients using propensity score weighting, no statistically significant differences regarding mortality rates were observed. Subgroup analysis of severely underweight patients (BMI <18.5 kg/m²) revealed no significant increase of mortality after TAVI compared with underweight patients (BMI <20 kg/m2), whereas severely underweight SAVR patients showed twofold increased mortality rates. In conclusion, underweight in patients who underwent TAVI or SAVR is rare, but it is associated with increased mortality. Especially severely underweight SAVR patients showed excess mortality rates.
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Implantación de Prótesis de Válvulas Cardíacas , Complicaciones Posoperatorias/epidemiología , Accidente Cerebrovascular/epidemiología , Delgadez/epidemiología , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/epidemiología , Índice de Masa Corporal , Gasto Cardíaco Bajo/epidemiología , Enfermedad de la Arteria Coronaria/epidemiología , Transfusión de Eritrocitos/estadística & datos numéricos , Femenino , Alemania/epidemiología , Humanos , Hipertensión Pulmonar/epidemiología , Unidades de Cuidados Intensivos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Mortalidad , Prevalencia , Pronóstico , Enfermedad Pulmonar Obstructiva Crónica/epidemiología , Diálisis Renal/estadística & datos numéricos , Respiración Artificial/estadística & datos numéricos , Índice de Severidad de la Enfermedad , Volumen SistólicoRESUMEN
AIMS: We aimed to assess the prevalence and features of prosthesis-patient mismatch (PPM) following transcatheter aortic valve implantation (TAVI) and its prognostic impact considering baseline left ventricular ejection fraction (LVEF). METHODS AND RESULTS: Data from 1,309 patients undergoing TAVI for severe aortic stenosis were derived from a single-centre dedicated TAVI registry. PPM was assessed according to echocardiography at discharge and was defined in accordance with VARC-2. Median follow-up time was 2.03 years. Moderate and severe PPM was detected in 22.9% and 12.9%, respectively. Patients with severe PPM had smaller annuli and more often received transcatheter heart valve (THV) sizes ≤23 mm. Supra-annular THV design showed the lowest rate of PPM. In patients with LVEF <40%, but not in those with LVEF ≥40%, severe PPM was associated with an increased three-year mortality rate (no vs. severe PPM for LVEF ≥40%: 34.6% vs. 29.5%, p=0.96; LVEF <40%: 45.1% vs. 68.0%, p=0.041) and was independently predictive of all-cause mortality according to multivariate analysis in these patients (HR 2.97; 95% CI: 1.58-5.59, p<0.001). CONCLUSIONS: The presence of severe PPM depends on annular dimensions and THV size and design and is an independent predictor of mortality in patients with reduced LVEF. Hence, the risk of PPM should be considered within the process of THV selection.