Outcomes Following Transcatheter Aortic Valve Replacement for Degenerative Stentless Versus Stented Bioprostheses

ObjectivesA large comprehensive analysis of transcatheter aortic valve replacement (TAVR) was performed for failed stentless bioprostheses.BackgroundValve-in-valve (ViV) transcatheter aortic replacement (TAVR) is an alternative to redo surgery for patients with a failing aortic bioprosthesis.MethodsUnadjusted outcome data were collected from the VIVID (Valve-in-Valve International Data) registry between 2007 and 2016 from a total of 1,598 aortic ViV procedures (291 stentless, 1,307 stented bioprostheses).ResultsBioprosthetic failure was secondary to aortic regurgitation in 56% of stentless and 20% stented devices (p < 0.001). ViV-TAVR access was transfemoral in 71.1% stentless and 74.2% stented ViV-TAVR. Self-expanding devices were more frequently used in stentless ViV-TAVR (56.0% vs. 39.9%; p = 0.05), but there was no difference between balloon-expanding and self-expanding TAVR devices for stented ViV-TAVR (48.6% vs. 45.1%). The degree of oversizing for all mechanisms of bioprosthesis failure was 9 ± 10% for stentless ViV-TAVR vs. 6 ± 9% for stented ViV-TAVR (and 8 ± 10% for stentless ViV-TAVR vs. 3 ± 9% for stented ViV-TAVR in patients with predominant aortic regurgitation; both p < 0.001). Initial device malposition (10.3% vs. 6.2%; p = 0.014), second transcatheter device (7.9% vs. 3.4%), coronary obstruction (6.0% vs. 1.5%), and paravalvular leak occurred more frequently in stentless ViV-TAVR (all p < 0.001). Hospital stay duration (median 7 days) was no different, and 30-day (6.6% vs. 4.4%; p = 0.12) and 1-year mortality year (15.8% vs. 12.6%; p = 0.15) were numerically higher, but not statistically different, after stentless ViV-TAVR.ConclusionsStentless ViV-TAVR is associated with greater periprocedural complications (initial device malposition, second transcatheter device, coronary obstruction, paravalvular leak), but no difference in 30-day and 1-year outcome.     

Short-term hemodynamic performance of the Sorin Freedom SOLO stentless valve

BACKGROUND AND AIM OF THE STUDY: The new Sorin Freedom SOLO pericardial stentless valve is designed for supra-annular implantation, and requires only one running suture. It can be implanted with a short cross-clamp time, and is designed to offer the same hemodynamic advantages of other stentless valves. The study aim was to evaluate the prospective postoperative and two-month follow up hemodynamic performance of this bioprosthesis. METHODS: Thirty patients (13 males, 17 females; mean age 75.6 +/- 6.21 years) with severe aortic stenosis underwent valve replacement with the Sorin Freedom SOLO stentless valve. All patients underwent transthoracic echocardiography before surgery, before hospital discharge, and at two months' follow up. The peak and mean transprosthetic gradients, telediastolic and telesystolic diameters, septal and posterior wall thicknesses, total and indexed ventricular mass volume and left ventricular ejection fraction were evaluated. RESULTS: Both, the transprosthetic peak gradient and mean gradient decreased significantly during the first two months (p < 0.05 and p < 0.001, respectively). The telediastolic diameter was significantly reduced between preoperative evaluation and follow up (p < 0.05). The interventricular septum thickness was decreased significantly after two months (p <0.001), as was the posterior wall thickness, albeit to a lesser degree (p < 0.05). Both, total and indexed ventricular mass volume showed a significant regression at the two months follow up (p < 0.001). CONCLUSION: The Sorin Freedom SOLO stentless valve shows good hemodynamic performance, with an early and highly progressive left ventricular remod eling. If these data are confirmed in future studies, the SOLO prosthesis might represent a safe alternative to the use of conventional stentless valves.     

The Impact of Aortic Angulation on Contemporary Transcatheter Aortic Valve Replacement Outcomes

ObjectivesThe aim of this study was to investigate whether the degree of aortic angulation (AA) affects outcomes after transcatheter aortic valve replacement (TAVR) using newer-generation transcatheter heart valves (THVs).BackgroundAA ≥48° has been reported to adversely influence accurate THV deployment, procedural success, fluoroscopy time, and paravalvular leak (PVL) in patients undergoing TAVR with early generation self-expanding (SE) THVs.MethodsA retrospective observational study was conducted among 841 patients across all risk strata who underwent transfemoral TAVR using the balloon-expandable (BE) SAPIEN 3 or the SE CoreValve Evolut PRO from 2015 to 2020. The previously published cutoff of 48° was used to analyze procedural success and in-hospital outcomes according to THV type. Receiver-operating characteristic analysis was performed to investigate the impact of AA on an in-hospital composite outcome (need for >1 THV, more than mild PVL, new permanent pacemaker implantation, stroke, and death).ResultsAA ≥48° did not influence outcomes in patients with BE THVs. Additionally, AA ≥48° did not influence procedural success (99.1% vs. 99.1%; p = 0.980), number of THVs used (1.02 vs. 1.04; p = 0.484), rates of more than mild PVL (0.4% vs. 0%; p = 0.486), new permanent pacemaker implantation (11.8% vs. 17.1%; p = 0.178), in-hospital stroke (3.9% vs. 1.8%; p = 0.298), or in-hospital death (0.4% vs. 0.9%; p = 0.980) in patients with SE THVs. Receiver-operating characteristic analysis demonstrated similar outcomes irrespective of AA, with areas under the curve of 0.5525 for SE THVs and 0.5115 for BE THVs.ConclusionsAA no longer plays a role with new-generation BE or SE THVs in contemporary TAVR practice. AA ≥48° did not affect procedural success or in-hospital outcomes and should no longer be a consideration when determining THV selection.     

Trans-Catheter Aortic Valve Replacement and Surgical Aortic Valve Replacement Outcomes in Patients with Dialysis: Systematic Review and Meta-Analysis

BackgroundDialysis is associated with higher rate of aortic valve calcification and higher cardiovascular mortality. Transcatheter aortic valve replacement (TAVR) is an established alternative for surgical aortic valve replacement (SAVR) in patients with higher and intermediate co-morbidities including dialysis.MethodsTwo independent investigators systematically searched Medline, Cochrane, and Web of Science. The ROBINS-I tool was used to analyze and assess the bias from the selected studies.ResultsThe search resulted in 4 observational studies with a total of 966 patients. TAVR in dialysis patients was associated with no significant difference in in-hospital mortality [8.1% vs 10.3%; OR (95% CI) 0.74 (0.35, 1.60), I2 = 50%, P = 0.45], risk-of-strokes at 30 days [2% vs 4.4%; OR (95% CI) 0.49 (0.22, 1.09), I2 = 0%, P = 0.08], vascular complications [12.7% vs 13.2%; OR (95% CI) 0.96 (0.55, 1.67), I2 = 0%, P = 0.89], need of blood transfusion [43.1% vs 66.4%; OR (95% CI) 0.27 (0.05, 1.39), I2 = 89%, P = 0.12], or bleeding risk [5.6% vs 6.8%; OR (95% CI) 0.91 (0.18, 4.64), I2 = 5%, P = 0.91] when compared to SAVR. TAVR was associated with significantly shorter length of stay [8.5 days vs 14.2 days; mean difference (95% CI) ?5.89 (?9.13, ?2.64), I2 = 76%, P < 0.0001] and higher pacemaker implantation [11.4% vs 6.8%; OR (95% CI) 1.74 (1.07, 2.81), I2 = 5%, P = 0.02].ConclusionTAVR outcomes were comparable to SAVR but had a significantly shorter length of stay and a higher pacemaker implantation rate in dialysis patients.     

Outcomes of Surgical Aortic Valve Replacement: The Benchmark for Percutaneous Therapies

Historically, many patients with severe senile calcific aortic valve stenosis (AS) were not offered surgery, largely due to the perception that the risks of operation were prohibitive. Such patients have subsequently been formally designated as ‘high risk’ or ‘inoperable’ with respect to their suitability for surgical aortic valve replacement (SAVR) in the evolving lexicon of heart valve disease. The recent availability of transcatheter aortic valve replacement (TAVR) represents an alternative treatment option, and permits the opportunity to re-examine algorithms for assessing operative risk. As the experience with TAVR grows, expanded use in new patient populations can be anticipated. While TAVR in high risk AS patients has demonstrated benefits, the emerging indication in intermediate AS is less clear and conclusions will necessarily await the availability of results from ongoing clinical trials. This article will discuss current outcomes for SAVR among high- and intermediate-risk patients with AS as a barometer in assessing the results of nascent percutaneous therapies.     

Outcomes Following Shock Aortic Valve Replacement: Transcatheter Versus Surgical Approaches

ObjectivesTo compare transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) for patients in shock.BackgroundThere are minimal data on the clinical and echocardiographic outcomes for patients in shock that undergo TAVR and no data comparing these outcomes to similar patients undergoing SAVR.MethodsThis is a single center, retrospective cohort study of patients having Society of Thoracic Surgeons (STS)-defined urgent or emergent AVR for aortic stenosis with clinical signs and symptoms of shock. Inclusion criteria were based on the Society of Cardiovascular Angiography & Interventions (SCAI) shock consensus statement and included: the need for inotropic or vasopressor agents, mechanical ventilation, continuous renal replacement therapy or newly initiated hemodialysis, and/or utilization of mechanical hemodynamic support. Clinical and echocardiographic outcomes for TAVR and SAVR were compared.ResultsThirty-seven patients met the inclusion criteria for this study (17 TAVR, 20 SAVR). TAVR patients had a higher STS Predicted Risk of Mortality (PROM) score of 22.3% compared to 11.8% for SAVR patients (p = 0.001). No significant differences were found in baseline echocardiographic results. TAVR procedures required less procedure room time (185.9 min TAVR, 348.5 min SAVR, p < 0.001) and fewer intraoperative packed red blood cell (pRBC) transfusions (0.2 units TAVR, 3.4 units SAVR, p < 0.001). TAVR patients also had lower rates of prolonged postoperative ventilation compared to SAVR patients (38.5% TAVR, 75.0% SAVR, p = 0.047). TAVR and SAVR had similar rates of mortality at discharge (2 TAVR, 1 SAVR, p = 0.584), 30-days (2 TAVR, 1 SAVR, p = 0.584), and 1-year (8 TAVR, 5 SAVR, p = 0.149).ConclusionsDespite a higher risk TAVR group, patients in shock undergoing either TAVR or SAVR have similar 30-day mortality. At one year, SAVR patients have a numerically better, though not statistically significant, survival. These findings support the use of TAVR for patients in shock with aortic stenosis.     

经腋动脉入路行经皮主动脉瓣置入术治疗主动脉瓣重度狭窄的安全性和有效性

【摘要】目的 经腋动脉入路行经皮主动脉瓣置入术治疗主动脉瓣重度狭窄的安全性和有效性。方法 回顾性分析多家中心2019年1月至2021年5月行TAVR手术的主动脉瓣狭窄患者135例。根据入路分为2组,经腋动脉入路组11例（11/135,8.1%）,经股动脉入路组124例（124/135,92%）。结果 两组均未出现死亡病例。围手术期内共有1例（1/135,0.74%）患者术后需行ECMO（体外膜肺氧合）辅助循环,发生于经腋动脉入路组,两组间有显著的统计学差异（P＜0.01）。术中左室破裂1例（1/135,0.74%）,中转外科手术1例（1/135,0.74%）,术后致残性脑卒中1例（1/135,0.74%）,均发生于经股动脉入路组,两组比较未见统计学差异。术后外周血管并发症3例（3/135,2.2%）,经腋动脉入路1例（1/11,9.1%）,经股动脉入路2例（2/124,1.6%）,两组比较未见统计学差异。术后起搏器植入10例（10/135,7.4%）,均发生于经股动脉组,两组比较未见统计学差异。结论 经腋动脉入路行经皮主动脉瓣置入术与经股动脉入路有相似的临床结果,是有效及安全的治疗方法。     

Relationship Between Hospital Surgical Aortic Valve Replacement Volume and Transcatheter Aortic Valve Replacement Outcomes

ObjectivesThe aim of this study was to examine whether hospital surgical aortic valve replacement (SAVR) volume was associated with corresponding transcatheter aortic valve replacement (TAVR) outcomes.BackgroundRecent studies have demonstrated a volume-outcome relationship for TAVR.MethodsIn total, 208,400 fee-for-service Medicare beneficiaries were analyzed for all aortic valve replacement procedures from 2012 to 2015. Claims for patients <65 years of age, concomitant coronary artery bypass grafting surgery, other heart valve procedures, or other major open heart procedures were excluded, as were secondary admissions for aortic valve replacement. Hospital SAVR volumes were stratified on the basis of mean annual SAVR procedures during the study period. The primary outcomes were 30-day and 1-year post-operative TAVR survival. Adjusted survival following TAVR was assessed using multivariate Cox regression.ResultsA total of 65,757 SAVR and 42,967 TAVR admissions were evaluated. Among TAVR procedures, 21.7% (n = 9,324) were performed at hospitals with <100 (group 1), 35.6% (n = 15,298) at centers with 100 to 199 (group 2), 22.9% (n = 9,828) at centers with 200 to 299 (group 3), and 19.8% (n = 8,517) at hospitals with ≥300 SAVR cases/year (group 4). Compared with group 4, 30-day TAVR mortality risk-adjusted odds ratios were 1.32 (95% confidence interval: 1.18 to 1.47) for group 1, 1.25 (95% confidence interval: 1.12 to 1.39) for group 2, and 1.08 (95% confidence interval: 0.82 to 1.25) for group 3. These adjusted survival differences in TAVR outcomes persisted at 1 year post-procedure.ConclusionsTotal hospital SAVR volume appears to be correlated with TAVR outcomes, with higher 30-day and 1-year mortality observed at low-volume centers. These data support the importance of a viable surgical program within the heart team, and the use of minimum SAVR hospital thresholds may be considered as an additional metric for TAVR performance.