Benefits and Pitfalls of the Perceval Sutureless Bioprosthesis

Objective: To highlight the main target points covered by clinical studies on the Perceval sutureless valve for surgical aortic valve replacement (SAVR) and raise a point of discussion for further expansion of its use when compared with stented bioprostheses (SB) and transcatheter aortic valve replacement (TAVR).Methods: We reviewed clinical trials and retrospective studies published up to date and compared the outcomes in terms of mortality, myocardial infarction (MI) stroke, paravalvular leak (PVL), permanent pacemaker implantation (PPI), bleeding and long-term outcomes.Results: Clinical studies showed that 30-day mortality ranged from 0–4% for Perceval and 2.9–7% for TAVR. The incidence of PVL (Perceval 1.9–19.4 vs. TAVR 9–53.5%), PPI (Perceval 2–11.2 vs. TAVR 4.9–25.5%), stroke (Perceval 0 vs. TAVR 0–2.8%), MI (Perceval 0 vs. TAVR 0–3.5%), were all higher in the TAVR group. Compared to other SB, mortality ranged from 0–6.4% for Perceval and 0–5.9% for SB. The incidence of PVR (Perceval 1–19.4 vs. SB 0–1%), PPI (Perceval 2–10.7 vs. SB 1.8–8.5%), stroke (Perceval 0–3.7 vs. SB 1.8–7.3%) and MI (Perceval 0–7.8 vs. SB 0–4.3%) were comparable among the groups. In patients with a bicuspid aortic valve, mortality rate was (0–4%) and PVL incidence was (0–2.3%). However, there was a high incidence of PPI (0–20%), and stroke (0–8%). Long-term survival ranged between 96.7–98.6%.Conclusions: The Perceval bioprosthesis has proved to be a reliable prosthesis for surgical aortic valve replacement due to its implantation speed, the reduced cardiopulmonary bypass time, the reduced aortic cross-clamp time and the shorter intensive care unit and hospital length of stay.

Monitoring the Evolution of Asynchrony between Mean Arterial Pressure and Mean Cerebral Blood Flow via Cross-Entropy Methods

Cerebrovascular control is carried out by multiple nonlinear mechanisms imposing a certain degree of coupling between mean arterial pressure (MAP) and mean cerebral blood flow (MCBF). We explored the ability of two nonlinear tools in the information domain, namely cross-approximate entropy (CApEn) and cross-sample entropy (CSampEn), to assess the degree of asynchrony between the spontaneous fluctuations of MAP and MCBF. CApEn and CSampEn were computed as a function of the translation time. The analysis was carried out in 23 subjects undergoing recordings at rest in supine position (REST) and during active standing (STAND), before and after surgical aortic valve replacement (SAVR). We found that at REST the degree of asynchrony raised, and the rate of increase in asynchrony with the translation time decreased after SAVR. These results are likely the consequence of the limited variability of MAP observed after surgery at REST, more than the consequence of a modified cerebrovascular control, given that the observed differences disappeared during STAND. CApEn and CSampEn can be utilized fruitfully in the context of the evaluation of cerebrovascular control via the noninvasive acquisition of the spontaneous MAP and MCBF variability.

Rockwood Clinical Frailty Scale as a predictor of adverse outcomes among older adults undergoing aortic valve replacement: a protocol for a systematic review

IntroductionFrailty is associated with adverse outcomes relating to cardiac procedures. It has been proposed that frailty scoring should be included in the preoperative assessment of patients undergoing aortic valve replacement. We aim to examine the Rockwood Clinical Frailty Scale (CFS), as a predictor of adverse outcomes following aortic valve replacement.Methods and analysisProspective and retrospective cohort studies and randomised controlled trials assessing both the preoperative frailty status (as per the CFS) and incidence of adverse outcomes among older adults undergoing either surgical aortic valve replacement or transcatheter aortic valve replacement will be included. Adverse outcomes will include mortality and periprocedural complications, as well as a composite of 30-day complications. A search will be conducted from 2005 to present using a prespecified search strategy. Studies will be screened for inclusion by two reviewers, with methodological quality assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Relative risk ratios with 95% CIs will be generated for each outcome of interest, comparing frail with non-frail groups. Data will be plotted on forest plots where applicable. The quality of the evidence will be determined using the Grading of Recommendations, Assessment, Development and Evaluation tool.Ethics and disseminationEthical approval is not required for this study as no primary data will be collected. We will publish the review in a peer-reviewed journal on completion.PROSPERO registration numberCRD42020213757.

Surgery after Failed Transcatheter Aortic Valve Implantation: Indications and Outcomes of a Concerning Condition

Objectives: The number of transcatheter aortic valve implantations (TAVI) has increased enormously in recent decades. Transcatheter valve prosthesis failure and the requirement of conventional surgical replacement are expected to attract more focus in the near future. Indeed, given the scarcity of research in this field, the next decade will likely represent the beginning of a period of meaningful exploration of the degenerative changes that occur with transcatheter valves. The current study represents—through a series of consecutive cases—one of the first analyses of the underlying causes of TAVI failure, i.e., degenerative, functional and infective, followed by surgical aortic valve replacement (SAVR) and postoperative outcome. Methods: Between October 2008 and March 2021, 2098 TAVI procedures, including 1423 with transfemoral, 309 with transapical, and 366 with transaortic access, were performed in our institution. Among these, 0.5% (number(n) = 11) required acute SAVR (n = 6) within 7 days (n = 3) or later (n = 2), and were included in the study. Results: Valve stent dislocation was the most common cause of replacement (83%). Causes of replacement within 7 days after TAVI were multifactorial. In the later course, endocarditis was the sole indication for SAVR after TAVI. TAVI with transapical or transaortal approach had a higher EuroSCORE II (10.9 (7.2–35.3) vs. 3.5 (1.8–7.8)). Their 30-day mortality after surgical conversion was higher (67% vs. 20%), when compared to those who underwent a transfemoral procedure. The longest documented survival beyond 30 days was 58 months. Conclusions: The causes of SAVR after TAVI failure are multifactorial, and include biological, physical and infectious factors. An acceptable midterm prognosis may be expected in patients with physical causes when dislocation of the catheter prosthesis is observed; in such cases, emergency conversion is required. Conversion due to infection, as in cases of endocarditis, had the worst outcome. Prognosis after conversion due to degeneration is still problematic, due to a lack of autopsies and the recent history of prosthetic implantations.

The Aortic Annulus Stabilization Technique Prevents Paravalvular Leaks after Rapid Deployment Aortic Valve Implantation

Background: Surgical aortic valve replacement with rapid deployment bioprosthesis guarantees good hemodynamic results but carries the risk of paravalvular leaks. To address this issue, an annulus stabilization technique has been recently developed. Methods: Clinical and hemodynamic parameters from patients treated for aortic valve replacement with the rapid deployment bioprosthesis and a concomitant annulus stabilization technique were prospectively collected and retrospectively analyzed. Echocardiographic data at discharge and at 1-year follow-up were collected and analysed. Results: A total of 57 patients (mean age 74.3 ± 6.1 years) with symptomatic aortic valve stenosis underwent aortic valve replacement with the rapid deployment bioprosthesis and concomitant annulus stabilization technique (mean valve size: 23.8 ± 1.9 mm). Combined procedures accounted for 56.1%. Hospital mortality was 1.8% and a new pacemaker for conduction abnormalities was implanted in 10 patients. The pre-discharge echocardiographic control showed absence of paravalvular leaks of any degree in all patients with mean valve gradient of 9.6 ± 4.0 mmHg. The 1-year echocardiographic control confirmed the good valve hemodynamic (mean gradient of 8.0 ± 2.8 mmHg) and absence of leaks. Conclusion: In this preliminary clinical experience, the annulus stabilization technique prevents postoperative paravalvular leaks after rapid deployment aortic valve implantation, up to 1-year postoperatively. Studies on larger series are of paramount importance to confirm the long-term efficacy of this new surgical technique.

464 Implantation of contemporary transcatheter aortic valves in small aortic annuli: the international multicentre TAVI-SMALL 2 registry

Aims In patients with severe aortic stenosis, trans-prosthetic haemodynamics after transcatheter aortic valve implantation (TAVI) tend to be more favourable than after surgical aortic valve replacement, especially after self-expandable valve (SEV) implantation. The relative performance of TAVI according to leaflet position, that is supra-annular and intra-annular valves (SAV and IAV, respectively), has not been investigated thoroughly. Moreover, prosthesis-patient mismatch (PPM) is more common in patients with small aortic annuli, even though its clinical impact after TAVI is debated. Compare haemodynamics and clinical outcomes of transcatheter SAV and IAV in patients with small annuli. Methods TAVI SMALL 2 is an international retrospective registry of 1378 patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 on computed tomography) treated with transfemoral transcatheter SEV (Evolut R/Pro, n = 750, Acurate Neo, n = 170 and Portico n = 172) and balloon-expandable valves (BEV, Sapien 3, n = 286) in 16 high-volume centres. Analyses were performed according to mechanism of valve release, that is SEV (n = 1092) vs. BEV (n = 286), and according to leaflet position, that is SAV (Evolut R/Pro and Acurate Neo, n = 920) vs. IAV (Sapien 3 and Portico, n = 458). Primary endpoints were pre-discharge mean aortic gradient and incidence of severe PPM. Secondary endpoint was incidence of all-cause mortality. Results Pre-discharge mean aortic gradient was lower both after SAV vs. IAV (7.8 ± 3.9 vs. 12.0 ± 5.1, P <0.001) and SEV vs. BEV implantation (8.0 ± 4.1 vs. 13.6 ± 4.7, P<0.001). IAV implantation was more often complicated by severe PPM when compared to SAV implantation (8.8% vs. 3.6%, P = 0.007), and severe PPM was more common after BEV than after SEV implantation (8.7% vs. 4.6%, P = 0.041). At a median follow-up of 377 days (interquartile range 168–700 days), all-cause mortality occurred in 11.9% of patients after IAV and 9.4% after SAV implantation (P = 0.172), and in 12.3% and 9.8% of BEV and SEV groups, respectively (P = 0.218). Results were confirmed at Kaplan-Meier analysis (log-rank P = 0.748 and 0.687 for SAV vs. IAV and SEV vs. BEV, respectively, Figure 1). Pre-discharge more than mild paravalvular leak (PVL) was more common with SEV than BEV (11.6% vs. 2.6%, P <0.001), while incidence of more than moderate PVL was higher both after SAV vs. IAV (1.5% vs. 0.2%, P = 0.043) and SEV vs. BEV implantation (1.4% vs. 0%, P = 0.052). New permanent pacemaker implantation was higher after SEV than BEV (13.5% vs. 8.1%, P = 0.013). Conclusions In this high-numerosity registry of patients with small aortic annuli, TAVI with SAV and SEV yielded a more favourable forward haemodynamic profile than after IAV and BEV implantation, respectively. All-cause mortality did not differ between groups.

Post-operative Atrial Fibrillation Impacts on Outcomes in Transcatheter and Surgical Aortic Valve Replacement

Background: Atrial fibrillation (AF) in severe aortic stenosis (AS) has poor outcomes after transcatheter and surgical aortic valve replacement (TAVR and SAVR, respectively). We compared the incidence of AF after aortic valve replacement (AVR) according to the treatment method and the impact of AF on outcomes.Methods: We investigated the incidence of AF and clinical outcomes of AVR according to whether AF occurred after TAVR and SAVR after propensity score (PS)-matching for 1 year follow-up. Clinical outcomes were defined as death, stroke, and admission due to heart failure. The composite outcome comprised death, stroke, and admission due to heart failure.Results: A total of 221 patients with severe AS were enrolled consecutively, 100 of whom underwent TAVR and 121 underwent SAVR. The incidence of newly detected AF was significantly higher in the SAVR group before PS-matching (6.0 vs. 40.5%, P < 0.001) and after PS-matching (7.5 vs. 35.6%, P = 0.001). TAVR and SAVR showed no significant differences in outcomes except in terms of stroke. In the TAVR group, AF history did not affect the outcomes; however, in the SAVR group, AF history affected death (log rank P = 0.038). Post-AVR AF had a worse impact on admission due to heart failure (log rank P = 0.049) and composite outcomes in the SAVR group. Post-AVR AF had a worse impact on admission due to heart failure (log rank P = 0.008) and composite outcome in the TAVR group.Conclusion: Post-AVR AF could be considered as a predictor of the outcomes of AVR. TAVR might be a favorable treatment option for patients with severe symptomatic AS who are at high-risk for AF development or who have a history of AF because the occurrence of AF was more frequent in the SAVR group.