Examining lack of referrals to heart valve specialists as mechanisms of potential underutilization of aortic valve replacement.

BACKGROUND: Recent studies suggest that aortic valve replacement (AVR) remains underutilized. AIMS: Investigate the potential role of non-referral to heart valve specialists (HVS) on AVR utilization. METHODS: Patients with severe aortic stenosis (AS) between 2015 and 2018, who met class I indication for intervention, were identified. Baseline data and process-related parameters were collected to analyze referral predictors and evaluate outcomes. RESULTS: Among 981 patients meeting criteria AVR, 790 patients (80.5%) were assessed by HVS within six months of index TTE. Factors linked to reduced referral included increasing age (OR: 0.95; 95% CI: 0.94-0.97; P < .001), unmarried status (OR: 0.59; 95% CI: 0.43-0.83; P = .002) and inpatient TTE (OR: 0.27; 95% CI: 0.19-0.38; P < .001). Conversely, higher hematocrit (OR: 1.13; 95% CI: 1.09-1.16; P < .001) and eGFR (OR: 1.01; 95% CI: 1.00-1.02; P = .003), mean aortic valve gradient (OR: 1.03; 95% CI: 1.01-1.04; P < .001) and preserved LVEF (OR: 1.59; 95% CI: 1.02-2.48; P = .04), were associated with increased referral likelihood. Moreover, patients assessed by HVS referral as a time-dependent covariate had a significantly lower two-year mortality risk than those who were not (aHR: 0.30; 95% CI: 0.23-0.39; P < .001). CONCLUSION: A substantial proportion of severe AS patients meeting indications for AVR are not evaluated by HVS and experience markedly increased mortality. Further research is warranted to assess the efficacy of care delivery mechanisms, such as e-consults, and telemedicine, to improve access to HVS expertise.

A miR-125/Sirtuin-7 pathway drives the pro-calcific potential of myeloid cells in diabetic vascular disease.

AIMS/HYPOTHESIS: Ectopic calcification is a typical feature of diabetic vascular disease and resembles an accelerated ageing phenotype. We previously found an excess of myeloid calcifying cells in diabetic individuals. We herein examined molecular and cellular pathways linking atherosclerotic calcification with calcification by myeloid cells in the diabetic milieu. METHODS: We first examined the associations among coronary calcification, myeloid calcifying cell levels and mononuclear cell gene expression in a cross-sectional study of 87 participants with type 2 diabetes undergoing elective coronary angiography. Then, we undertook in vitro studies on mesenchymal stem cells and the THP-1 myeloid cell line to verify the causal relationships of the observed associations. RESULTS: Coronary calcification was associated with 2.8-times-higher myeloid calcifying cell levels (p=0.037) and 50% elevated expression of the osteogenic gene RUNX2 in mononuclear cells, whereas expression of Sirtuin-7 (SIRT7) was inversely correlated with calcification. In standard differentiation assays of mesenchymal stem cells, SIRT7 knockdown activated the osteogenic program and worsened calcification, especially in the presence of high (20 mmol/l) glucose. In the myeloid cell line THP-1, SIRT7 downregulation drove a pro-calcific phenotype, whereas SIRT7 overexpression prevented high-glucose-induced calcification. Through the Janus kinase (JAK)/signal transducer and activator of transcription (STAT) pathway, high glucose induced miR-125b-5p, which in turn targeted SIRT7 in myeloid cells and was directly associated with coronary calcification. CONCLUSIONS/INTERPRETATION: We describe a new pathway elicited by high glucose through the JAK/STAT cascade, involving regulation of SIRT7 by miR-125b-5p and driving calcification by myeloid cells. This pathway is associated with coronary calcification in diabetic individuals and may be a target against diabetic vascular disease. DATA AVAILABILITY: RNA sequencing data are deposited in GEO (accession number GSE193510; https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE193510 ).

Prevalence and Prognostic Impact of Carotid Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: To assess the prevalence of atherosclerotic carotid artery disease (ACAD) in patients undergoing transcatheter aortic valve implantation (TAVI) and postoperative cerebrovascular accidents (CVAs) and evaluate its prognostic impact on postoperative CVAs. METHODS: A retrospective review of all consecutive patients with severe symptomatic aortic valve stenosis (AVS) who underwent TAVI was conducted at a single tertiary university hospital (January 2008-December 2018). Patients with AVS scheduled for TAVI and concomitant carotid stenosis were evaluated for prophylactic carotid revascularization (carotid endarterectomy [CEA] or carotid artery stenting [CAS]). RESULTS: Seven hundred and seventy one consecutive patients (mean age: 80 years, 52% males) were treated by TAVI procedures. Carotid stenosis > 70% was detected in 69 patients (9%); it was unilateral in 47 (68%) and bilateral in 22 (32%) patients. Prophylactic carotid revascularization was performed before TAVI in 45 patients (31%): in 63.1% of patients (30/47) with unilateral carotid stenosis > 70% and in 68.1% (15/22) with bilateral carotid stenosis > 70%. Postoperative CVA following TAVI procedures were recorded in 25 patients (3.2%): 22 cases of stroke (2.8%) and 3 cases of transient ischemic attack (0.4%). At a multiple logistic regression, only bilateral carotid stenosis > 70% (odds ratio [OR] 1.16, confidence interval [CI] 95% 1.03-1.31; P = 0.0009) was found as independent predictors of periprocedural CVA. CONCLUSIONS: In patients with severe symptomatic AVS undergoing TAVI, carotid stenosis was frequently observed. Unilateral carotid stenosis > 70% did not show a significant association with early CVA following TAVI. However, in the cohort of patients with bilateral carotid stenosis > 70%, a significant association with postoperative CVA was observed.

Twilight-specific light cues.

The TWILIGHT-SYNERGY subgroup analysis demonstrated comparable safety and efficacy of the bioabsorbable polymer (BP) everolimus-eluting stent versus durable polymer DES in high-risk patients undergoing PCI, as well as advantage of 3 months DAPT followed by ticagrelor monotherapy, as compared with long term DAPT, in term of ischemic and hemorrhagic profile irrespective of DES type. This study confirms and extends previous evidences about safety profile of BP-DES and short term DAPT also in high risk patients. Future studies should focus on further technological improvements and on particular clinical setting where these devices could prove potential superiority.

Improvement of symptoms and coronary perfusion gradient with mechanical left ventricular unloading in flow-limiting complex spontaneous coronary artery dissection, without revascularization.

Spontaneous coronary artery dissection (SCAD) can lead to acute coronary syndrome and sudden cardiac death, particularly in young women. Observational data show that, in SCAD patients, both percutaneous coronary intervention and coronary artery bypass grafting seem to be hampered by higher technical complexity, lower success rates, and worse outcomes. As spontaneous healing is a common occurrence, expert consensus advices medical management of the acute phase, when feasible. We present the case of a young woman with SCAD of left anterior descending artery causing myocardial infarction with ST-segment elevation. High-anatomical complexity and unstable conditions of the patient made both medical management and immediate revascularization unfeasible options. Therefore, we decided to implant a percutaneous off-loading mechanical support device to improve coronary perfusion pressure by unloading the left ventricle and preserve cardiac function, preventing worse complications of acute myocardial infarction. This strategy was successful in stabilizing the patient, until the definitive revascularization treatment became an option.

Four-year mortality in women and men after transfemoral transcatheter aortic valve implantation using the SAPIEN 3.

OBJECTIVES: To investigate 4-year, post-transcatheter aortic valve implantation (TAVI) survival and predictors of survival by sex, in a real-world cohort that underwent transfemoral TAVI with SAPIEN 3 transcatheter heart valve. BACKGROUND: Previous TAVI investigations of first-generation devices demonstrated an early- to mid-term survival advantage in women compared with men. METHODS: SOURCE 3 (SAPIEN 3 Aortic Bioprosthesis European Outcome) is a post-approval, multicentre, observational registry. Patients (N = 1,694, 49.2% women, age 81.7 ± 6.7 years) with severe aortic stenosis and high surgical risk (logistic EuroSCORE 17.8%) underwent TAVI between 2014 and 2015. Kaplan-Meier event estimates were used to determine mortality by sex. Predictors of overall mortality were identified using a cox multivariate proportional hazard model. RESULTS: At 4 years, women had lower all-cause mortality than men (36.0 vs 39.7%; p = .0911; HR: 0.87 [95% CI: 0.75-1.02]). No difference was observed for cardiac mortality between women 24.2% and men 24.7% (p = .76; HR: 0.97 [95% CI: 0.79-1.19]). When adjusted for baseline characteristics (age, height, weight, NYHA functional class, renal insufficiency, EuroScore, and tricuspid regurgitation), sex had no impact on mortality. CONCLUSIONS: In this large, real-world cohort, all-cause mortality trended lower in women than men at 4 years post TAVI; however, several baseline factors, but not sex, were predictors of mortality. No difference between sexes was observed for cardiovascular mortality.

Prevalence, predictors, and outcomes of patient prosthesis mismatch in women undergoing TAVI for severe aortic stenosis: Insights from the WIN-TAVI registry.

OBJECTIVE: To evaluate the incidence, predictors and outcomes of female patients with patient-prosthesis mismatch (PPM) following transcatheter aortic valve intervention (TAVI) for severe aortic stenosis (AS). BACKGROUND: Female AS TAVI recipients have a significantly lower mortality than surgical aortic valve replacement (SAVR) recipients, which could be attributed to the potentially lower PPM rates. TAVI has been associated with lower rates of PPM compared to SAVR. PPM in females post TAVI has not been investigated to date. METHODS: The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multicenter registry of women undergoing TAVR for severe symptomatic AS. Two hundred and fifty patients with detailed periprocedural and follow-up echocardiographic investigations were included in the WIN-TAVI echocardiographic sub-study. PPM was defined as per European guidelines stratified by the presence of obesity. RESULTS: The incidence of PPM in our population was 32.8%. Patients with PPM had significantly higher BMI (27.4 ± 6.1 vs. 25.2 ± 5.0, p = .002), smaller sized valves implanted (percentage of TAVI ≤23 mm 61% vs. 29.2%, PPM vs. no PPM, p < .001) and were more often treated with balloon expandable valves (48.3 vs. 32.5%, p < .001) rather than self expanding ones (26.3 vs. 52.8%, <.001). BMI (OR = 1.08; 95%CI 1.02-1.14, p = .011) and valve size ≤23 mm (OR = 3.00 95%CI 1.14-7.94, p = .027) were the only independent predictors of PPM. There was no significant interaction between valve size and valve type (p = .203). No significant differences were observed in 1-year mortality or major adverse cardiovascular events. CONCLUSIONS: PPM in females undergoing TAVI occurs in one third of patients. BMI and valve size ≤23 mm are independent predictors. Larger registries are required to determine the impact of PPM on future clinical outcomes.

Incidence, predictors and clinical impact of permanent pacemaker insertion in women following transcatheter aortic valve implantation: Insights from a prospective multinational registry.

OBJECTIVES: To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women. BACKGROUND: Data on pacemaker insertion complicating TAVR in women are scarce. METHODS: The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints. RESULTS: Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85-7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30-0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9-16] days in PPI vs. 9 [7-14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups (adj HR 0.95, 95% CI 0.60-1.52, p = 0.84 and adj HR 1.22, 95% CI 0.83-1.79, p = 0.31, respectively). CONCLUSION: Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes.

Preprocedural anemia in females undergoing transcatheter aortic valve implantation: Insights from the WIN-TAVI registry.

OBJECTIVES: To assess the impact of anemia on clinical outcomes in female patients enrolled in the Women's InterNational transcatheter aortic valve implantation (WIN-TAVI) registry. BACKGROUND: Anemia is highly prevalent among females who constitute half of TAVI candidates, yet, its clinical significance remains poorly investigated. METHODS: Patients were divided into three groups according to preprocedural hemoglobin (Hb) level: (1) no anemia (Hb ≥12 g/dl), (2) mild-to-moderate anemia (10 ≤ Hb <12 g/dl), and (3) severe anemia (Hb <10 g/dl). The primary outcome was the occurrence of Valve Academic Research Consortium (VARC)-2 efficacy endpoint, a composite of mortality, stroke, myocardial infarction (MI), hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. RESULTS: Hemoglobin level was available in 877 (86.1%) patients: 412 (47.0%) had no anemia, 363 (41.4%) had mild-to-moderate anemia, and 102 (11.6%) had severe anemia. The latter group had a higher prevalence of cardiovascular risk factors. Compared with patients without anemia, severe anemia was associated with a greater risk of VARC-2 efficacy endpoint (adj HR 1.71, 95% CI: 1.02-2.87, p = .04), all-cause death (adj HR 2.36, 95% CI: 1.31-4.26, p = .004) and a composite of death, MI or stroke (adj HR 1.88, 95% CI: 1.10-3.22, p = .02) at 1 year. Moreover, an increased risk of late mortality (adj HR 1.15, 95% CI: 1.02-1.30, p = .03) was observed with every 1 g/dl decrease in hemoglobin level. CONCLUSION: Severe anemia in females undergoing TAVI was independently associated with increased rates of VARC-2 efficacy endpoint and mortality at 1 year.

An EAPCI Expert Consensus Document on Ischaemia with Non-Obstructive Coronary Arteries in Collaboration with European Society of Cardiology Working Group on Coronary Pathophysiology & Microcirculation Endorsed by Coronary Vasomotor Disorders International Study Group.

This consensus document, a summary of the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI), appraises the importance of ischaemia with non-obstructive coronary arteries (INOCA). Angina pectoris affects approximately 112 million people globally. Up to 70% of patients undergoing invasive angiography do not have obstructive coronary artery disease, more common in women than in men, and a large proportion have INOCA as a cause of their symptoms. INOCA patients present with a wide spectrum of symptoms and signs that are often misdiagnosed as non-cardiac leading to under-diagnosis/investigation and under-treatment. INOCA can result from heterogeneous mechanism including coronary vasospasm and microvascular dysfunction and is not a benign condition. Compared to asymptomatic individuals, INOCA is associated with increased incidence of cardiovascular events, repeated hospital admissions, as well as impaired quality of life and associated increased health care costs. This consensus document provides a definition of INOCA and guidance to the community on the diagnostic approach and management of INOCA based on existing evidence from research and best available clinical practice; noting gaps in knowledge and potential areas for further investigation.

The anatomy is the plastic image of function: the role of the ventricle-aortic angle in TAVR.

The horizontal aorta of 51° or more, dilated annulus and severe asymmetric calcifications result the three anatomical key features in predicting worse outcome after transfemoral TAVR with the new iterations of self-expandable devices. These findings further validate the ESC guidelines on the importance of anatomical factors in favoring TAVR or surgical aortic valve replacement. Future trials on head to head comparison between valves and on the role of ancillary devices are important to refine final decision making of the heart team on the type of aortic valve replacement and type of valve.

Aortic valve replacement plus revascularization: The battle of surgical versus transcatheter approach still rages.

The current guidelines for primary aortic valve disease suggest, with different class of recommendation, concomitant coronary artery revascularization in all candidates to aortic valve replacement with angiographic evidence of significant coronary artery diameter stenosis (≥70%, ≥50% for left main stenosis) both for surgical or transcatheter approach. Initial (non-patient-level) pooled data analyses suggest that a percutaneous transcatheter approach confers similar outcomes compared to a surgical approach in patients with severe AS and CAD. Further scientific evidences from RCTs are warranted to clarify the prognostic impact of CAD on TAVR candidates and to identify the most appropriate revascularization strategy.

Coronary sinus reducer implantation in the middle cardiac vein for the treatment of refractory angina.

Coronary sinus Reducer is a current therapeutic treatment for patients with persistent refractory angina. We report a case of successful implantation of the device in the middle cardiac vein of a 65 years old female patient. The singular and unusual site for the Reducer was planned after a careful assessment of the venous drainage of the ischemic territory.

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.

Italian Society of Interventional Cardiology (GISE) position paper for Cath lab-specific preparedness recommendations for healthcare providers in case of suspected, probable or confirmed cases of COVID-19.

COVID-19 pandemic raised the issue to guarantee the proper level of care to patients with acute cardiovascular diseases and concomitant suspected or confirmed COVID-19 and, in the meantime safety and protection of healthcare providers. The aim of this position paper is to provide standards to healthcare facilities and healthcare providers on infection prevention and control measures during the management of suspected and confirmed cases of 2019-nCoV infection accessing in cath-lab. The document represents the view of the Italian Society of Interventional Cardiology (GISE), and it is based on recommendations from the main World and European Health Organizations (WHO, and ECDC) as well as from the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI).

Transcatheter aortic valve implantation (TAVI) in cardiogenic shock: TAVI-shock registry results.

OBJECTIVES: Aim of this study is to evaluate safety, feasibility, and mid-term outcome of transcatheter aortic valve implantation (TAVI) in cardiogenic shock (CS). BACKGROUND: Balloon aortic valvuloplasty in patients with severe aortic valve stenosis (SAS) complicated by CS is indicated but associated with a grim prognosis. TAVI might be a more reasonable treatment option in this setting but data are scant. METHODS: From March 2008 to February 2019, 51 patients with severe aortic valvulopathy (native SAS or degenerated aortic bioprosthesis) and CS treated by TAVI in 11 European centers were included in this multicenter registry. Demographic, clinical, and procedural data were collected, as well as clinical and echocardiographic follow-up. RESULTS: The mean age of our study population was 75.8 ± 13, 49% were women, and mean Society of Thoracic Surgeons (STS) score was 19 ± 15%. Device success was achieved in 94.1%, with a 5% incidence of moderate/severe paravalvular leak. The 30-day events were mortality 11.8%, stroke 2.0%, vascular complications 5.9%, and acute kidney injury 34%. Valve Academic Research Consortium-2 early safety endpoint was reached in 35.3% of cases. At 1-year of follow-up, the mortality rate was 25.7% and the readmission for congestive heart failure was 8.6%. CONCLUSIONS: TAVI seems to be a therapeutic option for patients with CS and SAS or degenerated aortic bioprosthesis in terms of both safety and efficacy at early and long-term follow-up.

The impact of chronic kidney disease in women undergoing transcatheter aortic valve replacement: Analysis from the Women's INternational Transcatheter Aortic Valve Implantation (WIN-TAVI) registry.

BACKGROUND: The prevalence of both chronic kidney disease (CKD) and aortic stenosis (AS) increase with age. Although baseline CKD is frequent in patients undergoing transcatheter aortic valve replacement (TAVR), its significance among women is largely unknown. METHODS: Women's INternational Transcatheter Aortic Valve Implantation (WIN-TAVI) is a multinational, prospective registry of women undergoing TAVR for severe AS. We included patients with available baseline estimated glomerular filtration rate (eGFR) and completed 1-year follow-up. Patients were categorized into three groups based on their eGFR: No CKD (normal kidney function to stage 2 CKD: eGFR ≥60 ml/min/1.73 m2 ); (b) mild CKD (stage 3a CKD: eGFR = 45-59 ml/min/1.73 m2 ); and (c) moderate/severe CKD (stage ≥3b CKD: eGFR <45 ml/min/1.73 m2 ). All events were adjudicated according to the Valve Academic Research Consortium (VARC)-2 criteria. RESULT: Out of 852 women undergoing TAVR, 326 (38.3%) had no CKD, 225 (26.4%) had mild CKD, and 301 (35.3%) had moderate/severe CKD. Women with higher stage of CKD at baseline were more likely to have a history of hypertension, diabetes, atrial fibrillation, anemia, chronic lung disease, hemodialysis, prior percutaneous coronary intervention, and pacemaker implantation. After multivariate adjustment, moderate/severe CKD was associated with a greater risk of 1-year VARC-2 safety endpoints [hazard ratio (HR) 1.68, 95% confidence interval (CI): 1.10-2.60], all-cause death (HR 2.00, 95% CI: 1.03-3.90), and composite of death, myocardial infarction, stroke or life-threatening bleeding (HR 1.70, 95% CI: 1.04-2.76). There were no differences in 30-day and 1-year VARC-2 efficacy and 30-day VARC-2 safety outcomes. CONCLUSION: CKD is associated with substantial and independent risk for mortality and morbidity at 1-year follow-up in women undergoing TAVR.

Time course of the survival advantage of transcatheter over surgical aortic valve replacement: Interplay between sex and patient risk profile.

OBJECTIVES: The aim of this study was to explore the time course of survival advantage of TAVR over SAVR as function of the patients' risk and sex. BACKGROUND: Women have been reported to have better survival than men undergoing transcatheter aortic valve replacement (TAVR). However, scant data on the sex-based survival benefit of TAVR over surgical aortic valve replacement (SAVR) are available. METHODS: A systematic review of studies reporting clinical outcomes of men and women undergoing TAVR or SAVR was performed. Studies were divided into two groups according to average patient's risk score and the interplay of surgical risk and sex on outcomes were analyzed. RESULTS: Eight studies involving 6,596 women and 7,204 men patients were extracted. Unlike mens, women patients had survival advantage from TAVR over SAVR that became substantial at 1 year from index procedure and persisted at 2-year of follow-up. Moreover, this sex-based TAVR survival advantage was mainly observed in higher surgical risk patients. Men showed a significantly lower rate of residual paravalvular leak after SAVR. CONCLUSIONS: Women patients had a selective mortality benefit from TAVR compared to SAVR. This sex-based TAVR benefit was mainly observed in high surgical risk patients beyond 1 year from procedure.

Impact of coronary artery disease and percutaneous coronary intervention in women undergoing transcatheter aortic valve replacement: From the WIN-TAVI registry.

OBJECTIVES: To evaluate the impact of coronary artery disease (CAD) with or without recent (≤ 30 days) percutaneous coronary intervention (PCI) in women undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Although women display a specific risk-profile for both PCI and TAVR, the impact of CAD and PCI in the setting of TAVR in women is unclear. METHODS: The multinational Women's International Transcatheter Aortic Valve implantation registry enrolled consecutive female patients undergoing contemporary TAVR in 19 centers between 2013 and 2015. Patients with available coronary angiography or CT scan in the pre-operative assessment of TAVR were categorized as without CAD, with CAD but no recent PCI and CAD and recent PCI (≤30 days). All events were adjudicated according to the VARC-2 criteria. RESULTS: A total of 787 patients were included in this analysis, among whom 459 (58.3%) had no CAD, 247 (31.4%) had CAD without recent PCI and 81 (10.3%) underwent recent PCI (≤ 30 days before TAVR). After multivariable adjustment, both groups of CAD patients, without and with recent PCI, presented with higher risk of death, myocardial infarction or stroke, compared with patients without CAD (adj HR 1.56, 95%CI 1.03-2.39, P = 0.038 and adj HR 1.96, 95% CI 1.1-3.5, P = .021, respectively). Patients with recent PCI had increased risk of all-cause death (adj HR 1.89, 95% CI 1.0-3.5, P = 0.04) and stroke (adj HR 3.7, 95% CI 1.0-13.5, P = 0.046) compared with patients without CAD. CONCLUSION: The presence of CAD in women undergoing TAVR, with or without recent PCI, was associated with long-term poorer outcomes.

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.