Association between surgical risk and 30-day stroke after transcatheter versus surgical aortic valve replacement: a systematic review and meta-analysis.

BACKGROUND: Stroke is a feared complication of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). OBJECTIVES: With this meta-analysis we aimed to evaluate the incidence of 30-day stroke with TAVR and SAVR focusing on its possible correlation with surgical risk. METHODS: Major electronic databases were searched for studies published between January 2002 and October 2019 reporting the rates of 30-day stroke after TAVR and SAVR. Data were pooled using fixed- and random-effects models. The primary outcome of the study was stroke rate within 30-day from TAVR or SAVR. Results were stratified according to surgical risk score (high, intermediate and low). RESULTS: A total of 23 studies were identified (TAVR: 14,589 patients; SAVR: 11,681 patients). Regardless of the model used, in the overall population TAVR was associated with a significant reduction in the risk of stroke compared with SAVR (fixed effect: OR 0.78, 95% CI 0.66-0.92, p = .003; random-effects: OR 0.80, 95% CI 0.64-1.00, p = .045). Rates of 30-day stroke after TAVR and SAVR were not significantly different in the high- (OR 1.01, 95% CI 0.44-1.98, p = .105) and intermediate-risk groups (OR 0.92, 95% CI 0.63-1.36, p = .319), while low-risk patients had a lower rate of 30-day stroke after TAVR than SAVR (OR 0.65, 95% CI 0.50-0.83, p < .001). Meta-regression showed a significant association between surgical risk score and 30-day stroke rate (p = .007). CONCLUSIONS: TAVR is associated with a lower risk of 30-day stroke compared with SAVR, mainly as a result of the significant advantage observed in patients at low surgical risk.

Treatment of aortic stenosis in patients with chronic liver disease: Another win for transfemoral TAVR?

Chronic liver disease is associated with increased operative risk of open-heart surgery. In this study, transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) carried high periprocedural mortality, but transfemoral TAVR appeared to be superior to SAVR in terms of long-term survival. Better risk stratification tools are needed for patients with liver dysfunction to avoid futile TAVR and SAVR procedures.

The impact of pre-existing peripheral artery disease on transcatheter aortic valve implantation outcomes: A systematic review and meta-analysis.

BACKGROUND: Peripheral arterial disease (PAD) plays a decisive role in the preinterventional selection process of the optimal vascular access site in patients undergoing transcatheter aortic valve implantation (TAVI). However, the impact of PAD on mortality and vascular complications (VCs) in TAVI-treated patients remains unclear. Accordingly, we aimed to assess the outcomes of patients with and without PAD undergoing TAVI, by performing a meta-regression analysis. METHODS: Studies published between January 2002 and March 2018 and reporting outcomes according to the presence of PAD in TAVI patients were identified. Outcome measures analyzed were short-, mid- and long-term mortality, and peri-procedural VC. The interaction between sheath size and PAD on outcomes was also assessed. RESULTS: A total of 26 studies (68,581 TAVI patients, of whom 17,326 with preprocedural PAD) were included in the analysis. Patients with PAD had higher risk of mortality at short- (HR 1.36, 95% confidence interval [CI] 1.13-1.63, p = .0009), mid- (HR 1.18, 95% CI 1.08-1.30, p = .0005), and long-term (HR 1.36, 95% CI 1.24-1.48, p < .0001) follow-up, and higher risk of VC (RR 1.55, 95% CI 1.27; 1.89, p < .0001). Moreover, the adoption of smaller sheaths during TAVI procedures was associated with fewer VC both in PAD and non-PAD patients, but the latter group had a more pronounced benefit. CONCLUSIONS: Patients with pre-existent PAD are at increased risk of all-cause mortality and VC after TAVI. The adoption of smaller sheaths during the procedure seems to be associated with fewer peri-procedural VC both in PAD and non-PAD patients.

Incidence and feasibility of coronary access after transcatheter aortic valve replacement.

BACKGROUND: Incidence of coronary access (CA) after transcatheter aortic valve replacement (TAVR) at long-term follow-up remains unknown. CA and percutaneous coronary intervention (PCI) after TAVR might present technical challenges, particularly with supra-annular devices. METHODS: Patients undergoing CA after being treated with TAVR at our institution were included in the study. Coronary interventions for coronary obstruction during TAVR procedure were excluded. Incidence, feasibility and outcomes of CA after TAVR were analyzed. RESULTS: Out of 912 patients aged 80 ± 7 years treated with TAVR at our institution between 2007 and 2018, 48 (5.3%) underwent CA at a median follow up of 769 [363-1,471] days. Twenty-one had received a SAPIEN XT, 15 a SAPIEN 3, 6 Corevalve, 2 Evolut Pro, 2 JenaValve, and 2 Lotus valve. PCI was indicated in 26 (54%) cases. Seventeen (35%) procedures were performed for acute coronary syndromes (ACS). Independent predictors of CA after TAVR were younger age, previous PCI, and CABG. CA of both vessels was feasible in all patients with an intra-annular device, while the right coronary artery was not engaged in two patients with a supra-annular valve. PCI was successful in all but one case. All-cause mortality was similar between patients needing CA for ACS and those who had other clinical indications. CONCLUSIONS: In this high-risk AS population, incidence of CA after TAVR at long-term follow-up was rather low. CA and PCI were safe and successful in most cases, with a lower rate of selective CA for supra-annular devices.

Factors influencing the choice between transcatheter and surgical treatment of severe aortic stenosis in patients younger than 80 years: Results from the OBSERVANT study.

OBJECTIVES: We aimed to analyze the baseline features and clinical outcomes of patients younger than 80 years undergoing transfemoral transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) real-world study, focusing on variables guiding Heart Team decision toward TAVI. BACKGROUND: Patients treated with TAVI, independently of surgical risk score, are mostly older than 80 years. METHODS: OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis (AS) who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals. For this analysis, baseline characteristics, therapeutic approach and outcomes up to 5 years of follow-up of 4,801 patients under 80 years of age were collected. Patients were stratified by age classes (<65, 65-74, and 75-79 years). RESULTS: Patients <80 years of age with severe symptomatic AS undergoing TAVI (n = 483) had significantly higher Logistic EuroSCORE (10.84% vs. 5.22%, p < .001) and prevalence of comorbidities compared to subjects undergoing SAVR (n = 4,318). The decision to perform TAVI over SAVR was driven by anatomical factors, mainly previous cardiac surgery (odds ratio [OR] 24.73, confidence interval [CI] 12.71-48.10, p < .001) and the presence of porcelain aorta (OR 17.44, CI 6.67-45.55, p < .001), and clinical factors, mainly moderate-severe frailty score (OR 5.49, CI 3.33-9.07, p < .001), oxygen dependency (OR 7.42, CI 2.75-20.04, p < .001) and need for dialytic treatment (OR 5.24, CI 1.54-17.80, p < .008). Among patients undergoing TAVI, those under 65 years had the highest baseline risk profile (despite a low Logistic EuroSCORE) and the highest 5-year mortality compared to those 65-74 and 75-79-year-old (65.22% vs. 48.54% vs. 55.24%, log-rank p = .061). CONCLUSION: Among patients under 80 years of age with symptomatic severe AS, only 10% underwent TAVI. These patients were at higher baseline risk compared to those undergoing SAVR. The decision to perform TAVI was driven by the presence of both anatomical and clinical factors beyond surgical risk scores. Patients under 65 years of age, despite the low Logistic EuroSCORE, had the highest preoperative risk profile and carried the worse outcome.

Transcatheter aortic valve implantation in lower-risk patients: what is the perspective?

In the last decade, transcatheter aortic valve implantation (TAVI), a disruptive technology, has revolutionized the therapy of symptomatic severe aortic stenosis, and current guidelines state that the recommendations for TAVI and surgical aortic valve replacement (SAVR) are equivalent in patients at high-risk. Increased operator experience, technical advances in the new generation of transcatheter heart valves (THV) and excellent TAVI results in recently published randomized controlled trials have led to the expansion of TAVI indication as an alternative to SAVR in intermediate-risk subjects, given appropriate patient selection. The time is opportune to examine the role of TAVI in low-risk patients, currently the objective of on-going randomized trials. This review aims to summarize the available knowledge on TAVI in low- to intermediate-risk patients and to discuss the potential advantages and pitfalls TAVI will face in this clinical setting.

The interplay between permanent pacemaker implantation and mortality in patients treated by transcatheter aortic valve implantation: A systematic review and meta-analysis.

BACKGROUND: Previous implantation of a permanent pacemaker (PPM) is common among patients undergoing transcatheter aortic valve implantation (TAVI). Moreover, onset of conduction disturbances needing new PPM implantation after TAVI is frequent. The interplay of pre-existing and new-PPM on mortality after TAVI remains controversial. METHODS: We performed a systematic review and study-level meta-analysis on the influence of PPM on mortality after TAVI. Patients were divided into 3 groups: pre-existing PPM, new-PPM (implantation within 30 days after TAVI) and no-PPM (without PPM up to 30 days after TAVI). Outcomes were compared using pairwise and network meta-analysis. RESULTS: A total of 28 studies including 40,016 subjects were eligible. Patients of the no-PPM group had a lower mortality outcome compared to the rest of the study population (relative risk [RR] 0.76, 95% confidence interval [CI] 0.68-0.85, P < 0.0001) at median follow up of 16.3 months. In particular, patients with a pre-existing PPM (RR 1.43, 95% CI 1.26-1.62, P < 0.0001), but not those with a newly implanted PPM (RR 1.08, 95% CI 0.99-1.18, P = 0.10), had a significantly higher mortality compared to patients of the no-PPM group. Moreover, meta-regression analysis showed that the transapical approach rate had a detrimental interaction with pre-existing PPM on mortality (P = 0.03). CONCLUSION: Compared to patients without PPM, those with a pre-existing PPM before TAVI had higher mortality, in particular if treated by the transapical approach. New-PPM implantation did not have a negative relation on mid-term outcome.

[Drug-eluting stents in contemporary interventional practice: the STENT PANORAMA project (Part I)]. / Gli stent coronarici a rilascio di farmaco nella pratica interventistica contemporanea: progetto STENT PANORAMA (Parte I).

STENT PANORAMA is a project carried out by the Young Interventional Cardiologists of Triveneto coordinated by the Italian Society of Interventional Cardiology (GISE) Veneto delegation. The project includes two parts: the first, here reported, is aimed at describing in a standardized and easily usable way the main technological characteristics of the latest generation of the drug eluting stents (DES) that are most widely used in the Italian cath-labs. The second, to follow, will aim to summarize the main scientific evidence regarding the performance of individual devices with particular reference to subgroups of clinical interest. The ambitious goal of the STENT PANORAMA working group is to provide the interventional cardiologist with a thorough, practical, and functional knowledge of the DES currently available in the modern therapeutic armamentarium to promote a therapeutic strategy tailored to the patient.

Updated definition of pulmonary hypertension and outcome after transcatheter aortic valve implantation.

OBJECTIVE: The European Society of Cardiology guidelines have recently defined new cut-offs for pulmonary hypertension (PH) and pulmonary vasculature resistance (PVR; median pulmonary artery pressure (mPAP) >20 instead of 25 mm Hg and PVR >2 instead of 3 Wood unit). The prognostic value of this updated classification after transcatheter aortic valve implantation (TAVI) is unknown. METHODS: 579 consecutive patients treated by TAVI with preprocedural right heart catheterisation evaluation were included. Patients were grouped as: (1) no PH, (2) isolated precapillary/combined (I-PreC/Co) PH and (3) isolated postcapillary PH (I-PoC). All-cause death, cardiovascular death and hospitalisations for heart failure (HF) were evaluated at follow-up. We also analysed the prognostic role of residual postprocedural PH. RESULTS: Out of 579 patients, 299 (52%) had PH according to the new criteria compared with 185 (32%) according to the previous ones. Overall median age was 82 years, while 55.3% patients were male. Patients with PH were more frequently diagnosed with chronic obstructive pulmonary disease and atrial fibrillation and were characterised by higher surgical risk as compared with patients without PH.At a median follow-up of 2.9 years, the presence of PH according to previous definition was associated with worse survival (p<0.001) and HF hospitalisation (p=0.002) rates, irrespective of PVR values. With newer cut-offs, PH was associated with worse outcomes only in patients with increased PVR, while no differences were found between patients with PH and normal PVR values and those without PH. Postprocedural mPAP normalisation was observed in 45% of the cases, but it was associated with improved long-term survival only in the I-PoC PH group. CONCLUSIONS: New ESC PH cut-offs increased the number of PH diagnoses. The presence of PH, particularly in the setting of increased PVR, identify patients at higher risk for postprocedural mortality and rehospitalisation. Normalisation of PH was associated with better survival only in I-PoC group.

A more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: an Italian post-maRketing study (the CAESAR registry).

Introduction: The use of contemporary drug-eluting stents (DES) has significantly improved outcomes of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, concerns exist regarding the long-term proinflammatory effects of durable polymer coatings used in most DES, potentially leading to long-term adverse events. First-generation polymer-free stent technologies, such as sirolimus- and probucol-eluting stents (PF-SES), have shown an excellent safety and efficacy profile. The aim of this study was to evaluate the safety and efficacy of the new ultrathin Coroflex ISAR NEO PF-SES, in a more-comers PCI population. Methods: The CAESAR (a more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: An Italian post-maRketing study) registry is a multicenter, prospective study conducted in Italy, enrolling more-comers CAD patients undergoing PCI with the Coroflex ISAR NEO stent. Patients with left main (LM) disease, cardiogenic shock (CS), or severely reduced left-ventricular ejection fraction (LVEF) were excluded. The primary endpoint was target-lesion revascularization (TLR) at 1 year. Results: A total of 425 patients were enrolled at 13 centers (mean age 66.9 ± 11.6 years, Diabetes mellitus 29%, acute coronary syndrome 67%, chronic total occlusion 9%). Of these, 40.9% had multivessel disease (MVD) and in 3.3% cases, the target lesion was in-stent restenosis (ISR). Clinical device success was reached in 422 (99.6%) cases. At 1 year, only two (0.5%) subjects presented ischemia-driven TLR. The 1-year rates of target vessel revascularization and MACE were 0.5% and 5.1%, respectively. Major bleeding was observed in four (1.0%) patients. Conclusion: In this multicenter, prospective registry, the use of a new ultrathin Coroflex ISAR NEO PF-SES in a more-comers PCI population showed good safety and efficacy at 1 year.

Management of coronary artery disease in patients undergoing transcatheter aortic valve implantation. A clinical consensus statement from the European Association of Percutaneous Cardiovascular Interventions in collaboration with the ESC Working Group on Cardiovascular Surgery.

Significant coronary artery disease (CAD) is a frequent finding in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI), and the management of these two conditions becomes of particular importance with the extension of the procedure to younger and lower-risk patients. Yet, the preprocedural diagnostic evaluation and the indications for treatment of significant CAD in TAVI candidates remain a matter of debate. In this clinical consensus statement, a group of experts from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) in collaboration with the European Society of Cardiology (ESC) Working Group on Cardiovascular Surgery aims to review the available evidence on the topic and proposes a rationale for the diagnostic evaluation and indications for percutaneous revascularisation of CAD in patients with severe aortic stenosis undergoing transcatheter treatment. Moreover, it also focuses on commissural alignment of transcatheter heart valves and coronary re-access after TAVI and redo-TAVI.