RESUMEN

The hemodynamic impact of the implantation depth for balloon-expandable valves is under-investigated, especially with higher implantation techniques. We assessed the hemodynamic performance of supra-annular SAPIEN 3 valve implantation. This retrospective study involved consecutive patients who underwent transcatheter aortic valve replacement (TAVR) using the SAPIEN 3. The device implantation depth and transcatheter heart valve (THV) leaflet-nadir position were angiographically analyzed, and supra-annular implantation was defined as a higher leaflet-nadir position than the original annular line. The Doppler hemodynamic status was evaluated at patient discharge. Among 184 patients, 120 (65%) underwent supra-annular implantation, and their mean implantation depth was significantly lower than that of intra-annular implantation (1.1 vs. 5.2 mm, p < 0.001). No patients developed valve embolization or coronary occlusion, and none required the TAV-in-TAV procedure. Two (1.6%) patients in the supra-annular implantation group had a mild or greater paravalvular leak. Echocardiography demonstrated that supra-annular implantation had better hemodynamic performance, showing a larger indexed effective orifice area (iEOA) compared with intra-annular implantation (1.09 vs. 0.97 cm2/m2, p < 0.01). There was a weak but negative correlation between the implantation depth and iEOA (r = - 0.27, p < 0.01). Moderate or severe prosthesis-patient mismatch (PPM) was found in 35.9% of the intra-annular group and 9.2% of supra-annular of the supra-annular group (p < 0.01). In the multivariable analysis, supra-annular implantation was an independent predictor of better THV function (iEOA > 0.85). Supra-annular SAPIEN 3 implantation provides beneficial hemodynamic effects and reduces the PPM risk.

RESUMEN

Background: The choice of transcatheter aortic valve replacement (TAVR) prosthesis is crucial in optimizing short- and long-term outcomes. The objective of this study was to conduct a meta-analysis comparing outcomes of third-generation balloon-expandable valves (BEV) vs self-expanding valves (SEV). Methods: Electronic databases were searched from inception to June 2023 for studies comparing third-generation BEV vs SEV. Primary outcome was all-cause mortality. Secondary outcomes included clinical and hemodynamic end points. Random-effects models were used to calculate pooled odds ratios (ORs) or weighted mean differences (WMDs). Results: The meta-analysis included 16 studies and 10,174 patients (BEV, 5753 and SEV, 4421). There were no significant differences in 1-year all-cause mortality (OR, 1.15; 95% CI, 0.89-1.48) between third-generation BEV vs SEV. TAVR with third generation BEV was associated with a significantly lower risk of TIA/stroke (OR, 0.62; 95% CI, 0.44-0.87), permanent pacemaker implantation (OR, 0.55; 95% CI, 0.44-0.70), and ≥moderate paravalvular leak (PVL, OR, 0.43; 95% CI, 0.25-0.75), and higher risk of ≥moderate patient-prosthesis mismatch (OR, 3.76; 95% CI, 2.33-6.05), higher mean gradient (WMD, 4.35; 95% CI, 3.63-5.08), and smaller effective orifice area (WMD, -0.30; 95% CI, -0.37 to -0.23), compared with SEV. Conclusion: In this meta-analysis, TAVR with third-generation BEV vs SEV was associated with similar all-cause mortality, lower risk of TIA/stroke, permanent pacemaker implantation, and ≥moderate PVL, but higher risk of ≥moderate patient-prosthesis mismatch, higher mean gradient, and smaller effective orifice area. Large, adequately powered randomized trials are needed to evaluate long-term outcomes of TAVR with latest generations of BEV vs SEV.

RESUMEN

INTRODUCTION: Over the past two decades, transcatheter aortic valve replacement (TAVR) has expanded its application across all surgical risk levels, including low-risk patients, where, due to longer life expectancy, reducing common pitfalls of TAVR is essential. To address these needs, many technological advancements have been developed. Myval and the new generation Myval Octacor (Meril Life Sciences Pvt. Ltd) are novel balloon-expandable (BE) transcatheter heart valve (THV) systems designed for the treatment of severe aortic stenosis. AREAS COVERED: This review aims to illustrate the design features of these novel THVs and the main evidence from available studies. Furthermore, we provide evidence of these THVs' performance in challenging scenarios such as extra-large aortic annuli, bicuspid aortic valves, and valve-in-valve/valve-in-ring procedures. EXPERT OPINION: Myval and Myval Octacor have demonstrated comparable early safety and clinical efficacy to the leading contemporary THVs, exhibiting remarkably low rates of moderate to severe paravalvular leak (PVL) and permanent pacemaker implantation (PPI). The wide range of sizes offered by the Myval family may minimize the risk of under-/oversizing, potentially explaining the lower rates of the aforementioned phenomena. Moreover, the presence of both internal skirt and external reinforced cuff may also explain the low rate of moderate to severe PVL.

Asunto(s)

Estenosis de la Válvula Aórtica , Bioprótesis , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estenosis de la Válvula Aórtica/cirugía , Índice de Severidad de la Enfermedad , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen

RESUMEN

BACKGROUND: Residual transprosthetic gradient (TG) after transcatheter aortic valve replacement (TAVR) with balloon-expandable valves (BEV) may be due to suboptimal valve expansion. AIMS: To compare hemodynamics after TAVR with small BEV according to postdilation strategy. METHODS: This observational, retrospective cohort study included 184 consecutive patients from a single center treated with 23 mm Sapien 3 Ultra (Edwards Lifesciences) BEV implantation in the aortic position and enrolled between January 2020 and April 2023. Patients treated with routine postdilation (RP, n = 73) were compared to patients treated according to local standard practice (SP, n = 111). Primary endpoint was 30-day mean TG. Secondary endpoints were incidence of 30-day prosthesis-patient mismatch (PPM), technical success and device success. RESULTS: Thirty-day mean TG was lower in RP versus SP (12.3 ± 4.6 mmHg vs. 14.1 ± 5.7 mmHg, p = 0.031), and incidence of PPM was less common with RP versus SP (47.3% vs. 71.0%, p = 0.006). Technical success (98.6% vs. 99.1%, p = 0.637) and device success (93.1% vs. 90.1%, p = 0.330) did not differ between groups. Differences in 30-day mean TG were driven by patients at normal flow (12.1 ± 4.0 mmHg vs. 15.0 ± 5.5 mmHg, p = 0.014), while no differences were evident among patients at low flow (12.5 ± 5.5 mmHg vs. 11.7 ± 5.5 mmHg, p = 0.644). RP decreased height and increased width of BEV, and a linear regression established that final BEV width could predict 30-day mean TG (r = -0.6654, p < 0.0001). CONCLUSIONS: RP after TAVR with small BEV was associated with more favorable forward-flow hemodynamics than SP.

RESUMEN

BACKGROUND: The anatomic substrate of bicuspid valves may lead to suboptimal TAVR stent expansion and geometry. AIM: We evaluated determinants of stent geometry in bicuspid valves treated with Sapien transcatheter aortic valve replacement (TAVR) valves. METHODS: A multicenter retrospective registry of patients (February 2019 to August 2022) who underwent post-TAVR computed tomography to determine stent area (vs. nominal valve area) and stent ellipticity (maximum diameter/minimum diameter). Predictors of relative stent expansion (minimum area/average of inflow + outflow area) and stent ellipticity were evaluated in a multivariable regression model, including valve calcium volume (indexed by annular area), presence of raphe calcium, sinus diameters indexed by area-derived annular diameter, and performance of pre-dilation and post-dilation. RESULTS: The registry enrolled 101 patients from four centers. The minimum stent area (vs. nominal area) was 88.1%, and the maximum ellipticity was 1.10, with both observed near the midframe of the valve in all cases. Relative stent expansion ≥90% was observed in 64/101 patients. The only significant predictor of relative stent expansion ≥90% was the performance of post-dilation (OR: 4.79, p = 0.018). Relative stent expansion ≥90% was seen in 86% of patients with post-dilation compared to 57% without (p < 0.001). The stent ellipticity ≥1.1 was observed in 47/101 patients. The significant predictors of stent ellipticity ≥1.1 were the indexed maximum sinus diameter (OR: 0.582, p = 0.021) and indexed intercommisural diameter at 4 mm (OR: 2.42, p = 0.001). Stent expansion has a weak negative correlation with post-TAVR mean gradient (r = -0.324, p < 0.001). CONCLUSION: Relative stent expansion ≥90% was associated with the performance of post-dilation, and stent ellipticity ≥1.1 was associated with indexed intercommisural diameter and indexed maximum sinus diameter. Further studies to determine optimal deployment strategies in bicuspid valves are needed.

Asunto(s)

Estenosis de la Válvula Aórtica , Válvula Aórtica , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Femenino , Masculino , Estudios Retrospectivos , Anciano de 80 o más Años , Resultado del Tratamiento , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Válvula Aórtica/fisiopatología , Anciano , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/fisiopatología , Enfermedad de la Válvula Aórtica Bicúspide/diagnóstico por imagen , Enfermedad de la Válvula Aórtica Bicúspide/cirugía , Valvuloplastia con Balón/efectos adversos , Factores de Riesgo , Estados Unidos , Stents

RESUMEN

Transcatheter aortic valve replacement in extra-large annulus is challenging because of the limited sizes and data of the current commercial prosthesis sizes available. We present a case of successful transcatheter aortic valve replacement with a new balloon-expandable SAPIEN 3 Ultra RESILIA valve for an aortic annulus area >1,000 mm2 on computed tomography.

RESUMEN

Background: For individuals with pure aortic regurgitation (AR), transcatheter aortic valve implantation (TAVI) is cautiously recommended only for those with a high or prohibitive surgical risk. We aimed to describe the results of a case series of transcatheter implantation of a balloon-expandable aortic valve bioprosthesis (BEV) for the treatment of noncalcified native valve AR. Methods: From February 2022-November 2022, we performed TAVI in patients with severe pure AR. Cases were indicated on the basis of symptoms, high/prohibitive surgical risk, or patient refusal of conventional treatment. Results: Five patients underwent successful TAVI. The mean age was 81.9 ± 6.6 years, 3 (60%) female and 5 (100%) in NYHA class III or IV. The baseline echocardiogram showed an ejection fraction of 49.0 ± 10.6% and left ventricular end-systolic diameter 28.5 ± 4.7 mm/m². The average area of the aortic annulus was 529.1 ± 47.0mm² and the area oversizing index was 17.6 ± 1.2%. In the 30-day follow-up, there were no cases of prosthesis embolization, annulus rupture, stroke, acute myocardial infarction, acute renal failure, hemorrhagic complication or death. One patient required a permanent pacemaker and another had a minor vascular complication. The clinical follow-up were 19.8 months (16.7-21.8). During this period, all patients remained alive and in NYHA class I or II. One of the patients developed a moderate paravalvular leak. Conclusion: TAVI with a BEV proved to be safe and effective in this small case series of patients with noncalcified native valve AR in a follow-up longer than 1 year.

RESUMEN

Introduction: Paravalvular leak (PVL) is a severe complication of transcatheter aortic valve replacement (TAVR) that can lead to poor outcomes. TAVR-in-TAVR is a promising treatment for PVL; however, reports on its safety or efficacy are limited. In this study, we aimed to investigate the clinical outcomes of TAVR-in-TAVR using balloon-expandable prostheses for PVLs after TAVR. Methods: We retrospectively analyzed data from patients who underwent TAVR-in-TAVR using balloon-expandable Sapien prostheses for PVL after an initial TAVR at our institution. The procedural success, in-hospital complications, all-cause mortality, and echocardiographic data for up to 2 years post-surgery were evaluated. Results: In total, 31 patients with a mean age of 81.1 ± 7.9 years and mean Society of Thoracic Surgeons score of 8.8 ± 5.4% were identified. The procedural success rate of TAVR-in-TAVR was 96.8% (30/31). No in-hospital deaths, cardiac tamponade, or conversion to sternotomy occurred. Re-intervention was performed in only one patient (3.2%) during hospitalization. The all-cause mortality rates at 30 days and 2 years were 0% and 16.1%, respectively. A significant reduction in the PVL rate was observed at 30 days compared with that at baseline (p < 0.01). Discussion: Our findings suggest that TAVR-in-TAVR using balloon-expandable prostheses is safe and effective for PVL after TAVR with low complication rates and acceptable long-term outcomes. Further studies with larger sample sizes are needed to confirm our findings.

RESUMEN

BACKGROUND: Candidates for transcatheter aortic valve replacement (TAVR) occasionally have a "borderline-size" aortic annulus between 2 transcatheter heart valve sizes, based on the manufacturer's sizing chart. Data on TAVR outcomes in such patients are limited. METHODS: We retrospectively reviewed 1816 patients who underwent transfemoral-TAVR with balloon-expandable valve (BEV) at our institution between 2016 and 2020. We divided patients into borderline and non-borderline groups based on computed tomography-derived annular measurements and compared outcomes. Furthermore, we analyzed procedural characteristics and compared outcomes between the smaller- and larger-valve strategies in patients with borderline-size annulus. RESULTS: During a median follow-up of 23.3 months, there was no significant difference between the borderline (n = 310, 17.0 %) and non-borderline (n = 1506) groups in mortality (17.3 % vs. 19.5 %; hazard ratio [HR] = 0.86 [95% CI = 0.62-1.20], p = 0.39), major adverse cardiac/cerebrovascular events (MACCE: death/myocardial infarction/stroke, 21.2 % vs. 21.5 %; HR = 0.97 [0.71-1.32], p = 0.85), paravalvular leak (PVL: mild 21.8 % vs. 20.6 %, p = 0.81; moderate 0 % vs. 1.2 %; p = 0.37), or mean gradient (12.9 ± 5.8 vs. 12.6 ± 5.2 mmHg, p = 0.69) at 1 year. There was no significant difference between the larger-(n = 113) and smaller-valve(n = 197) subgroups in mortality (23.7 % vs. 15.2 %; HR = 1.57 [0.89-2.77], p = 0.12), MACCE (28.1 % vs. 18.4 %; HR = 1.52 [0.91-2.54], p = 0.11), mild PVL (13.3 % vs. 25.9 %; p = 0.12), or mean gradient (12.3 ± 4.5 vs. 13.6 ± 5.3 mmHg, p = 0.16); however, the rate of permanent pacemaker implantation (PPI) was higher in the larger-valve subgroup (15.9 % vs. 2.6 %, p < 0.001). CONCLUSION: Borderline-size annulus is not associated with higher risk of adverse outcomes after BEV-TAVR. However, the larger-valve strategy for borderline-size annulus is associated with higher PPI risk, suggesting a greater risk of injury to the conduction system.

Asunto(s)

Estenosis de la Válvula Aórtica , Válvula Aórtica , Valvuloplastia con Balón , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Femenino , Masculino , Estudios Retrospectivos , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Resultado del Tratamiento , Anciano , Valvuloplastia con Balón/efectos adversos , Factores de Riesgo , Factores de Tiempo , Complicaciones Posoperatorias/etiología , Medición de Riesgo , Recuperación de la Función , Hemodinámica

RESUMEN

INTRODUCTION: Bicuspid aortic valve (BAV) stenosis is a complex anatomical scenario for transcatheter aortic valve implantation (TAVI). Favorable short-term clinical outcomes have been reported with TAVI in this setting, but long-term data are scarce. METHODS: We retrospectively included, in a single-center registry, patients with BAV stenosis who underwent TAVI before 2020. We compared patients treated with self-expanding valves (SEV) versus balloon-expandable valves (BEV). The primary endpoint was a composite of all-cause mortality, stroke and need for aortic valve (AV) reintervention at 3 years. Secondary endpoints included each component of the primary endpoint, cardiovascular mortality, permanent pacemaker implantation (PPI) rate, mean gradient and ≥moderate paravalvular leak (PVL) rate. RESULTS: A total of 150 consecutive patients (SEV = 83, BEV = 67) were included. No significant differences were reported between SEV and BEV groups for the primary composite endpoint (SEV 35.9% vs. BEV 32%, p = 0.66), neither for clinical secondary endpoints (all-cause mortality SEV 28.1% vs. BEV 28%, p = 0.988; cardiovascular mortality SEV 14.1% vs. BEV 20%, p = 0.399; stroke SEV 12.5% vs. BEV 6%, p = 0.342; need for AV reintervention SEV 0% vs. BEV 0%; PPI SEV 28.1% vs. BEV 24%, p = 0.620). A lower mean gradient persisted up to 3 years in the SEV group (SEV 8.8 ± 3.8 mmHg vs. BEV 10.7 ± 3.2 mmHg, p = 0.063), while no significant difference was found in the rate of ≥ moderate PVL (SEV 3/30 vs. BEV 0/25, p = 0.242). CONCLUSIONS: In this single center registry, we observed favorable 3-year clinical outcomes in nonselected BAV patients treated with different generation devices, without significant differences between patients receiving SEV or BEV.

Asunto(s)

Estenosis de la Válvula Aórtica , Valvuloplastia con Balón , Enfermedad de la Válvula Aórtica Bicúspide , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Masculino , Femenino , Estudios Retrospectivos , Resultado del Tratamiento , Enfermedad de la Válvula Aórtica Bicúspide/fisiopatología , Enfermedad de la Válvula Aórtica Bicúspide/diagnóstico por imagen , Enfermedad de la Válvula Aórtica Bicúspide/mortalidad , Enfermedad de la Válvula Aórtica Bicúspide/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/mortalidad , Factores de Tiempo , Anciano , Valvuloplastia con Balón/efectos adversos , Valvuloplastia con Balón/mortalidad , Anciano de 80 o más Años , Factores de Riesgo , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Válvula Aórtica/fisiopatología , Válvula Aórtica/anomalías , Recuperación de la Función , Hemodinámica , Medición de Riesgo

RESUMEN

An 83-year-old man with severe aortic stenosis underwent implantation of a 29-mm SAPIEN-3 (Edwards Lifesciences) transcatheter aortic valve (TAV) appropriately sized for an aortic annulus area of 543.6 mm2.

Asunto(s)

Aorta Torácica , Estenosis de la Válvula Aórtica , Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Masculino , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/cirugía , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Prótesis Valvulares Cardíacas/efectos adversos , Ecocardiografía Transesofágica/métodos , Diseño de Prótesis , Resultado del Tratamiento , Cateterismo Cardíaco/métodos

Asunto(s)

Estenosis de la Válvula Aórtica , Válvula Aórtica , Valvuloplastia con Balón , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Humanos , Masculino , Persona de Mediana Edad , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Recuperación de la Función , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Resultado del Tratamiento

RESUMEN

BACKGROUND: Redo-transcatheter aortic valve replacement (TAVR) can pin the index transcatheter heart valve leaflets open leading to sinus sequestration and restricting coronary access. The impact of initial implant depth and commissural alignment on redo-TAVR feasibility is unclear. We sought to determine the feasibility of redo-TAVR and coronary access after SAPIEN 3 (S3) TAVR stratified by implant depth and commissural alignment. METHODS: Consecutive patients with native valve aortic stenosis were evaluated using multidetector computed tomography. S3 TAVR simulations were done at 3 implant depths, sizing per manufacturer recommendation and assuming nominal expansion in all cases. Redo-TAVR was deemed unfeasible based on valve-to-sinotubular junction distance and valve-to-sinus height <2 mm, while the neoskirt plane of the S3 transcatheter heart valve estimated coronary access feasibility. RESULTS: Overall, 1900 patients (mean age, 80.2±8 years; STS-PROM [Society of Thoracic Surgeons Predicted Risk of Operative Mortality], 3.4%) were included. Redo-TAVR feasibility reduced significantly at shallower initial S3 implant depths (2.3% at 80:20 versus 27.5% at 100:0, P<0.001). Larger S3 sizes reduced redo-TAVR feasibility, but only in patients with a 100:0 implant (P<0.001). Commissural alignment would render redo-TAVR feasible in all patients, assuming the utilization of leaflet modification techniques to reduce the neoskirt height. Coronary access following TAV-in-TAV was affected by both index S3 implant depth and size. CONCLUSIONS: This study highlights the critical impact of implant depth, commissural alignment, and transcatheter heart valve size in predicting redo-TAVR feasibility. These findings highlight the necessity for individualized preprocedural planning, considering both immediate results and long-term prospects for reintervention as TAVR is increasingly utilized in younger patients with aortic stenosis.

Asunto(s)

Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Anciano , Anciano de 80 o más Años , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estudios de Factibilidad , Diseño de Prótesis , Resultado del Tratamiento , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Tomografía Computarizada por Rayos X , Factores de Riesgo

RESUMEN

BACKGROUND: Dialysis patients undergoing transcatheter aortic valve replacement (TAVR) face increased risk and have poorer outcomes than non-dialysis patients. Moreover, TAVR in dialysis patients using an alternative approach is considered extremely risky and little is known about the outcomes. We routinely perform minimum-incision transsubclavian TAVR (MITS-TAVR), which is contraindicated for transfemoral (TF) TAVR. This study aimed to evaluate the outcomes of MITS-TAVR compared with those of TF-TAVR in dialysis patients. METHODS: This single-center, observational study included 79 consecutive dialysis patients who underwent MITS-TAVR (MITS group, n = 22) or TF-TAVR (TF group, n = 57) under regional anesthesia. RESULTS: The rates of peripheral artery disease (MITS vs. TF, 72.7 % vs. 26.3 %; p < 0.01), shaggy aortas (MITS vs. TF, 63.6 % vs. 5.26 %; p < 0.01), and tortuous aortas (MITS vs. TF, 13.6 % vs. 1.75 %; p = 0.031) were significantly higher in the MITS group. The 30-day mortality was 2.53 % and comparable between the two groups (MITS vs. TF, 4.54 % vs. 1.75 %; p = 0.479). In the MITS group, 14 patients had ipsilateral dialysis fistulas, and three patients had patent in situ ipsilateral internal thoracic artery grafts; however, no vascular complications were observed. Kaplan-Meier survival curves for the two groups showed no significant difference in the survival rate (at 2 years; MITS vs. TF, 77.3 % vs. 68.8 %; p = 0.840) and freedom from cardiovascular mortality (at 2 years; MITS vs. TF, 90.9 % vs. 96.5 %; p = 0.898). The multivariable Cox proportional hazard model also indicated that survival in the MITS group was not significantly different from that in the TF group (hazard ratio 1.48; 95 % confidence interval, 0.77-2.85, p = 0.244). The patency rate of ipsilateral dialysis fistula was 100 % during follow-up. CONCLUSION: The outcome of MITS-TAVR was comparable to that of TF-TAVR in dialysis patients, despite the higher risk of patient characteristics.

Asunto(s)

Estenosis de la Válvula Aórtica , Diálisis Renal , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Masculino , Femenino , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Válvula Aórtica/cirugía , Prótesis Valvulares Cardíacas

Asunto(s)

Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Diseño de Prótesis , Factores de Riesgo

RESUMEN

A few studies have reported comparative analysis of clinical outcomes between balloon-expandable valve (BEV) and self-expandable valve (SEV) after transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis using newer-generation devices. However, those reports were mostly limited to short-term outcomes and Western populations. In the present study, data of patients with severe aortic stenosis who underwent TAVR between March 2016 and December 2018 were obtained from the National Health Insurance Service in Korea. The primary end point, defined as all-cause mortality, was compared in BEV (SAPIEN 3, Edwards Lifesciences, Irvine, California) and SEV (Evolut R, Medtronic, Minneapolis, MN) groups using a propensity-score matching analysis. Cumulative event rates of ischemic stroke, repeat procedures, and permanent pacemaker insertion (PPI) were evaluated as secondary outcomes. All events were followed up to a maximum of 3 years. A total of 1,172 patients underwent transfemoral TAVR, of whom 707 (60.3%) were treated with BEV and 452 (38.6%) with SEV. After 1:1 propensity-score matching, the BEV group showed lower all-cause mortality after a median follow-up of 12.0 months (mean: 13.1 ± 9.3 months) based on Cox proportional hazard model analysis (hazard ratio [HR] 0.67, 95% confidence interval [CI] 0.45 to 0.99, p = 0.04). Cumulative incidence of ischemic stroke was not statistically different between the 2 groups (HR 0.68, 95% CI 0.29 to 1.59, p = 0.37). PPI occurred less frequently in the BEV group (HR 0.4, 95% CI 0.25 to 0.64, p < 0.01). Repeat procedures were rare (1 patient in BEV and 2 patients in SEV group). In conclusion, Korean nation-wide data analysis showed that BEV was associated with less all-cause death and incidence of PPI after TAVR than was SEV using a newer-generation device.

Asunto(s)

Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Estenosis de la Válvula Aórtica/epidemiología , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/etiología , Incidencia , Resultado del Tratamiento , Válvula Aórtica/cirugía , Diseño de Prótesis

RESUMEN

BACKGROUND: Recent randomized studies have broadened the indication of transcatheter aortic valve replacement (TAVR) to also include low-surgical-risk patients. However, the data on self-expanding (SE) and balloon-expandable (BE) valves in low-risk patients remain sparse. METHODS: The current study is a post hoc analysis of combined data from both LRT 1.0 and 2.0 trials comparing BE and SE transcatheter heart valves. RESULTS: A total of 294 patients received a BE valve, and 102 patients received an SE valve. The 30-day clinical outcomes were similar across both groups except for stroke (4.9% vs. 0.7%, p = 0.014) and permanent pacemaker implantation (17.8% vs. 5.8%, p < 0.001), which were higher in the SE cohort than the BE cohort. No difference was observed in terms of paravalvular leak (≥moderate) between the groups (0% vs. 1.5%, p = 0.577). SE patients had higher aortic valve area (1.92 ± 0.43 mm2 vs. 1.69 ± 0.45 mm2, p < 0.001) and lower mean gradient (8.93 ± 3.53 mmHg vs. 13.41 ± 4.73 mmHg, p < 0.001) than BE patients. In addition, the rate of subclinical leaflet thrombosis was significantly lower in SE patients (5.6% vs. 13.8%, p = 0.038). CONCLUSION: In this non-randomized study assessing SE and BE valves in low-risk TAVR patients, SE valves are associated with better hemodynamics and lesser leaflet thrombosis, with increased rates of stroke and permanent pacemaker implantation at 30 days; however, this could be due to certain patient-dependent factors not fully evaluated in this study. The long-term implications of these outcomes on structural valve durability remain to be further investigated. CLINICAL TRIAL REGISTRY: LRT 1.0: NCT02628899 LRT 2.0: NCT03557242.

Asunto(s)

Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Accidente Cerebrovascular , Trombosis , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/etiología , Accidente Cerebrovascular/etiología , Trombosis/etiología , Resultado del Tratamiento , Diseño de Prótesis , Factores de Riesgo

RESUMEN

BACKGROUND: Conduction and rhythm abnormalities requiring permanent pacemakers (PPM) are short-term complications following transcatheter aortic valve replacement (TAVR), and their clinical outcomes remain conflicting. Potential novel predictors of post-TAVR PPM, like QRS duration, QTc prolongation, and supraventricular arrhythmias, have been poorly studied. AIM: To evaluate the effects of baseline nonspecific interventricular conduction delay and supraventricular arrhythmia on post-TAVR PPM requirement and determine the impact of PPM implantation on clinical outcomes. METHODS: A retrospective cohort study that identified patients with TAVR between January 1, 2012 to December 31, 2019. The group was dichotomized into those with post-TAVR PPM and those without PPM. Both groups were followed for one year. RESULTS: Out of the 357 patients that met inclusion criteria, the mean age was 80 years, 188 (52.7%) were male, and 57 (16%) had a PPM implantation. Baseline demographics, valve type, and cardiovascular risk factors were similar except for type II diabetes mellitus (DM), which was more prevalent in the PPM cohort (59.6% vs 40.7%; P = 0.009). The PPM cohort had a significantly higher rate of pre-procedure right bundle branch block, prolonged QRS > 120 ms, prolonged QTc > 470 ms, and supraventricular arrhythmias. There was a consistently significant increase in the odds ratio (OR) of PPM implantation for every 20 ms increase in the QRS duration above 100 ms: QRS 101-120 [OR: 2.44; confidence intervals (CI): 1.14-5.25; P = 0.022], QRS 121-140 (OR: 3.25; CI: 1.32-7.98; P = 0.010), QRS 141-160 (OR: 6.98; CI: 3.10-15.61; P < 0.001). After model adjustment for baseline risk factors, the OR remained significant for type II DM (aOR: 2.16; CI: 1.18-3.94; P = 0.012), QRS > 120 (aOR: 2.18; CI: 1.02-4.66; P = 0.045) and marginally significant for supraventricular arrhythmias (aOR: 1.82; CI: 0.97-3.42; P = 0.062). The PPM cohort had a higher adjusted OR of heart failure (HF) hospitalization (aOR: 2.2; CI: 1.1-4.3; P = 0.022) and nonfatal myocardial infarction (MI) (aOR: 3.9; CI: 1.1-14; P = 0.031) without any difference in mortality (aOR: 1.1; CI: 0.5-2.7; P = 0.796) at one year. CONCLUSION: Pre-TAVR type II DM and QRS duration > 120, regardless of the presence of bundle branch blocks, are predictors of post-TAVR PPM. At 1-year post-TAVR, patients with PPM have higher odds of HF hospitalization and MI.

RESUMEN

BACKGROUND: Coronary accessibility following redo-transcatheter aortic valve replacement (redo-TAVR) is increasingly important, particularly in younger low-risk patients. This study aimed to predict coronary accessibility after simulated Sapien-3 balloon-expandable valve implantation within an Evolut supra-annular, self-expanding valve using pre-TAVR computed tomography (CT) imaging. METHODS: A total of 219 pre-TAVR CT scans from the Evolut Low-Risk CT substudy were analyzed. Virtual Evolut and Sapien-3 valves were sized using CT-based diameters. Two initial Evolut implant depths were analyzed, 3 and 5 mm. Coronary accessibility was evaluated for 2 Sapien-3 in Evolut implant positions: Sapien-3 outflow at Evolut node 4 and Evolut node 5. RESULTS: With a 3-mm initial Evolut implant depth, suitable coronary access was predicted in 84% of patients with the Sapien-3 outflow at Evolut node 4, and in 31% of cases with the Sapien-3 outflow at Evolut node 5 (P<0.001). Coronary accessibility improved with a 5-mm Evolut implant depth: 97% at node 4 and 65% at node 5 (P<0.001). When comparing 3- to 5-mm Evolut implant depth, sinus sequestration was the lowest with Sapien-3 outflow at Evolut node 4 (13% versus 2%; P<0.001), and the highest at Evolut node 5 (61% versus 32%; P<0.001). CONCLUSIONS: Coronary accessibility after Sapien-3 in Evolut redo-TAVR relates to the initial Evolut implant depth, the Sapien-3 outflow position within the Evolut, and the native annular anatomy. This CT-based quantitative analysis may provide useful information to inform and refine individualized preprocedural CT planning of the initial TAVR and guide lifetime management for future coronary access after redo-TAVR. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02701283.

Asunto(s)

Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estenosis de la Válvula Aórtica/cirugía , Estudios de Factibilidad , Resultado del Tratamiento , Tomografía Computarizada por Rayos X , Diseño de Prótesis

RESUMEN

Background: In transcatheter aortic valve implantation (TAVI) using a SAPIEN3 balloon-expandable valve (S3), wire withdrawal from the left ventricle (LV) during the procedure before deployment can induce vascular injury in the access site or require surgical treatment when an S3 removal is attempted. We present a successful case of bailout from this situation safely with a minimally invasive technique using a 6-F snare catheter (SC). Case summary: An 86-year-old woman with severe aortic stenosis underwent trans-femoral TAVI using an S3 under conscious sedation. After a pre-shaped wire was inserted into the LV from the right femoral artery, the LV wire was accidentally withdrawn completely from the LV before deployment. Wire re-insertion using a soft straight wire through the tip lumen of the S3 was hindered because the wire orientation was uncontrollable. Hence, we used a 6-F SC to control the wire direction by changing the orientation of the S3. Catching the tip of the S3 with an SC at the ascending aorta enabled us to control the wire direction, and wire re-insertion in the LV with the soft wire was successful. Furthermore, the SC worked well in advancing the S3 through the aortic valve to enhance co-axiality without aortic root injury. The S3 was successfully advanced through the aortic valve and implanted at an optimal position without complications. Discussion: Our simple technique using a 6-F SC is technically effective, feasible, and minimally invasive and can be an option for bailout from accidental LV wire withdrawal during balloon-expandable valve TAVI.