Interventricular septal thickness on cardiac computed tomography as a novel risk factor for conduction disturbances in patients undergoing transcatheter aortic valve replacement.

AIMS: We examined whether thickness of the basal muscular interventricular septum (IVS), as measured by pre-procedural computed tomography (CT), could be used to identify the risk of conduction disturbances following transcatheter aortic valve replacement (TAVR). The IVS is a pivotal region of the electrical conduction system of the heart where the atrioventricular conduction axis is located. METHODS AND RESULTS: Included were 78 patients with severe aortic stenosis who underwent CT imaging prior to TAVR. The thickness of muscular IVS was measured in the coronal view, in systolic phases, at 1, 2, 5, and 10 mm below the membranous septum (MS). The primary endpoint was a composite of conduction disturbance following TAVR. Conduction disturbances occurred in 24 out of 78 patients (30.8%). Those with conduction disturbances were significantly more likely to have a thinner IVS than those without conduction disturbances at every measured IVS level (2.98 ± 0.52 mm vs. 3.38 ± 0.52 mm, 4.10 ± 1.02 mm vs. 4.65 ± 0.78 mm, 6.11 ± 1.12 mm vs. 6.88 ± 1.03 mm, and 9.72 ± 1.95 mm vs. 10.70 ± 1.55 mm for 1, 2, 5 and 10 mm below MS, respectively, P < 0.05 for all). Multivariable logistic regression analysis showed that pre-procedural IVS thickness (<4 mm at 2 mm below the MS) was a significant independent predictor of post-procedural conduction disturbance (adjOR 7.387, 95% CI: 2.003-27.244, P = 0.003). CONCLUSION: Pre-procedural CT assessment of basal IVS thickness is a novel predictive marker for the risk of conduction disturbances following TAVR. The IVS thickness potentially acts as an anatomical barrier protecting the underlying conduction system from mechanical compression during TAVR.

The Impact of Cerebral Embolic Protection Devices on Characteristics and Outcomes of Stroke Complicating TAVR.

BACKGROUND: Acute ischemic stroke remains a serious complication of transcatheter aortic valve replacement (TAVR). Cerebral embolic protection devices (CEPD) were developed to mitigate the risk of acute ischemic stroke complicating TAVR (AISCT). However, the existing body of evidence does not clearly support CEPD efficacy in AISCT prevention. OBJECTIVES: In a cohort of patients with AISCT, we aimed to compare the characteristics and outcomes of patients who have had unprotected TAVR (CEPD-) vs CEPD-protected TAVR (CEPD+). METHODS: Data were derived from an international multicenter registry focusing on AISCT. We included all patients who experienced ischemic stroke within 72 hours of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale (NIHSS). Primary outcomes were neurologic disability status according to the modified Rankin Score at 30 days, and 6-month all-cause death. Propensity score matched analysis was used to control for differences between groups. RESULTS: In 18,725 TAVR procedures, 416 AISCT (2.2%) within 72 hours were documented, of which 376 were in the CEPD- TAVR group and 40 in the CEPD+ TAVR group. Although the middle cerebral artery stroke rate was similar in both groups (29.7% CEPD- vs 33.3% CEPD+; P = 0.71), AISCT in the CEPD+ group was characterized by a lower rate of internal carotid artery occlusion (0% vs 4.7%) and higher rate of vertebrobasilar system strokes (15.4% vs 5.7%; P = 0.04). AISCT was severe (NIHSS ≥15) in 21.6% CEPD- and 23.3% CEPD+ AISCT (P = 0.20). Disabling stroke rates (modified Rankin Score >1 at 30 days) were 47.3% vs 42.5% (P = 0.62), and 6-month mortality was 31.3% vs 23.3% (P = 0.61), in the CEPD- and CEPD+ groups, respectively. In the propensity score matched cohort, disabling stroke rates were 56.5% vs 41.6% (P = 0.16), and 6-month mortality was 33% vs 19.5% (P = 0.35), in the CEPD- and CEPD+ groups, respectively. CONCLUSIONS: In a large cohort of patients with AISCT, the use of CEPD had little effect on stroke distribution, severity, and outcomes.

Outcomes of Drug-Eluting Balloons for In-Stent Restenosis: Large Cohort Analysis and Single-Center Clinical Experience.

BACKGROUND: The use of drug-eluting balloons (DEBs) remains clinically relevant in the contemporary era of drug-eluting stent percutaneous coronary interventions (DES-PCI), especially in the setting of in-stent restenosis (ISR). Our goal was to assess the outcomes of ISR patients in a large prospective registry. METHODS: A total of 2329 consecutive patients with ISR-PCI (675 using DEB and 1654 with DES) were treated in our medical centre from 2010 to 2021. Clinical end points included mortality and major adverse cardiac events (MACE) at 1 year. Clinical outcomes were adjusted for multiple confounders. RESULTS: Mean ages (65.9 ± 11.0 vs 66.1 ± 10.5; P = 0.73) and percentages of female patients (16.6% vs 18.2%; P = 0.353) were similar between both ISR groups. Patients treated with DEB for ISR suffered more from diabetes, hypertension, and previous myocardial infarction (P < 0.01 for all) and presented more frequently with acute coronary syndrome (40.0% vs 34.4%; P = 0.01) compared with patients treated with DES for ISR. One-year MACE was significantly higher in the DEB ISR-PCI group (23.4% vs 19.6%; P = 0.002) compared to the DES ISR-PCI group, but no significant differences in mortality were observed at 1 year between the groups. After adjustment for multiple confounders, DEB ISR-PCI was not associated with increased MACE at 1 year (P = 0.55). CONCLUSIONS: In our large experience, patients treated with DEB for ISR-PCI have higher baseline risk and sustained increased MACE rates compared with DES ISR-PCI patients. After adjustment for confounding variables, clinical outcomes are similar between the groups at 1 year after PCI.

Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk.

BACKGROUND: Patients treated with percutaneous coronary intervention are often considered to be at a high bleeding risk (HBR). Drug-eluting stents have been shown to be superior to bare-metal stents in patients with HBR, even when patients were given abbreviated periods of dual antiplatelet therapy (DAPT). Short DAPT has not been evaluated with the EluNIR ridaforolimus-eluting stent. The aim of this study was to evaluate the safety and efficacy of a shortened period of DAPT following implantation of the ridaforolimus-eluting stent in patients with HBR. METHODS AND RESULTS: This was a prospective, multicenter, binational, single-arm, open-label trial. Patients were defined as HBR according to the LEADERS-FREE (Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug-Coated Stent versus the Gazelle Bare-Metal Stent in Patients at High Bleeding Risk) trial criteria. After percutaneous coronary intervention, DAPT was given for 1 month to patients presenting with stable angina. In patients presenting with an acute coronary syndrome, DAPT was given for 1 to 3 months, at the investigator's discretion. The primary end point was a composite of cardiac death, myocardial infarction, or stent thrombosis up to 1 year (Academic Research Consortium definite and probable). Three hundred fifteen patients undergoing percutaneous coronary intervention were enrolled, and 56.4% presented with acute coronary syndrome; 33.7% were receiving oral anticoagulation. At 1 year, the primary end point occurred in 15 patients (4.9%), meeting the prespecified performance goal of 14.1% (P<0.0001). Stent thrombosis (Academic Research Consortium definite and probable) occurred in 2 patients (0.6%). Bleeding Academic Research Consortium type 3 and 5 bleeding occurred in 6 patients (1.9%). CONCLUSIONS: We observed favorable results in patients with HBR who underwent percutaneous coronary intervention with a ridaforolimus-eluting stent and received shortened DAPT, including a low rate of ischemic events and low rate of stent thrombosis. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03877848.

Percutaneous coronary intervention with ridaforolimus eluting-stents in small vessel coronary artery disease.

INTRODUCTION: The ridaforolimus-eluting stent (RES) system uses a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. AIM OF STUDY: To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease. METHODS: A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in-stent residual diameter stenosis <30%, without 30-day major adverse cardiovascular events (MACE). RESULTS: A total of 81 patients were enrolled in the study. Twenty-three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30-day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty-day and 1-year MACE rates were 1.2% and 2.5%, respectively. CONCLUSION: The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type.

First-in-human study of the CAPTIS embolic protection system during transcatheter aortic valve replacement.

BACKGROUND: Stroke and other clinically significant embolic complications are well documented in the early period following transcatheter aortic valve replacement (TAVR). The CAPTIS device is an embolic protection system, designed to provide neurovascular and systemic protection by deflecting debris away from the brain's circulation, capturing the debris and thus avoiding systemic embolisation. AIMS: We aimed to study the safety and feasibility study of the CAPTIS complete cerebral and full-body embolic protection system during TAVR. METHODS: A first-in-human study investigated the safety, feasibility and debris capturing ability of CAPTIS during TAVR. Patients were followed for 30 days. The primary endpoints were device safety and cerebrovascular events at 72 hours. RESULTS: Twenty patients underwent TAVR using balloon-expandable or self-expanding valve systems. CAPTIS was successfully delivered, positioned, deployed, and retrieved in all cases, and TAVR was successfully completed without device-related complications. No cerebrovascular events were observed. High numbers of debris particles were captured in all patients. CONCLUSIONS: The use of the CAPTIS full-body embolic protection system during TAVR was safe, and it captured a substantial number of debris particles. No patient suffered from a cerebrovascular event. A randomised clinical trial is warranted to prove its efficacy.

The Impact of Sex on Cardiogenic Shock Outcomes Following ST Elevation Myocardial Infarction.

BACKGROUND: Cardiogenic shock (CS) remains the leading cause of ST elevation myocardial infarction (STEMI)-related mortality. Contemporary studies have shown no sex-related differences in mortality. METHODS: STEMI-CS patients undergoing primary percutaneous coronary intervention (PPCI) were included based on a dedicated prospective STEMI database. We compared sex-specific differences in CS characteristics at baseline, during hospitalization, and in subsequent clinical outcomes. Endpoints included all-cause mortality and major adverse cardiac events (MACE). RESULTS: Of 3202 consecutive STEMI patients, 210 (6.5%) had CS, of which 63 (30.0%) were women. Women were older than men (73.2 vs. 65.5% y, p < 0.01), and more had hypertension (68.3 vs. 52.8%, p = 0.019) and diabetes (38.7 vs. 24.8%, p = 0.047). Fewer were smokers (13.3 vs. 41.2%, p < 0.01), had previous PCI (9.1 vs. 22.3% p = 0.016), or required IABP (35.3 vs. 51.1% p = 0.027). Women had higher rates of mortality (53.2 vs. 35.3% in-hospital, p = 0.01; 61.3 vs. 41.9% at 1 month, p = 0.01; and 73.8 vs. 52.6% at 3 years, p = 0.05) and MACE (60.6 vs. 41.6% in-hospital, p = 0.032; 66.1 vs. 45.6% at 1 month, p = 0.007; and 62.9 vs. 80.3% at 3 years, p = 0.015). After multivariate adjustment, female sex remained an independent factor for death (HR-2.42 [95% CI 1.014-5.033], p = 0.042) and MACE (HR-1.91 [95% CI 1.217-3.031], p = 0.01). CONCLUSIONS: CS complicating STEMI is associated with greater short- and long-term mortality and MACE in women. Sex-focused measures to improve diagnosis and treatment are mandatory for CS patients.

Incidence, predictors, and prognostic impact of new permanent pacemaker implantation after TAVR with self-expanding valves

OBJECTIVES: The authors sought to evaluate the incidence, predictors, and outcomes of new permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with contemporary self-expanding valves (SEV). BACKGROUND: Need for PPI is frequent post-TAVR, but conflicting data exist on new-generation SEV and on the prognostic impact of PPI. METHODS: This study included 3,211 patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries (January 2012 to December 2021) who underwent transfemoral TAVR with SEV. Implanted transcatheter heart valves (THV) were Acurate neo (n = 1,090), Acurate neo2 (n = 665), Evolut PRO (n = 1,312), and Evolut PRO+ (n = 144). Incidence and predictors of new PPI and 1-year outcomes were evaluated. RESULTS: New PPI was needed in 362 patients (11.3%) within 30 days after TAVR (8.8%, 7.7%, 15.2%, and 10.4%, respectively, after Acurate neo, Acurate neo2, Evolut PRO, and Evolut PRO+). Independent predictors of new PPI were Society of Thoracic Surgeons Predicted Risk of Mortality score, baseline right bundle branch block and depth of THV implantation, both in patients treated with Acurate neo/neo2 and in those treated with Evolut PRO/PRO+. Predischarge reduction in ejection fraction (EF) was more frequent in patients requiring PPI (P = 0.014). New PPI was associated with higher 1-year mortality (16.9% vs 10.8%; adjusted HR: 1.66; 95% CI: 1.13-2.43; P = 0.010), particularly in patients with baseline EF <40% (P for interaction = 0.049). CONCLUSIONS: New PPI was frequently needed after TAVR with SEV (11.3%) and was associated with higher 1-year mortality, particularly in patients with EF <40%. Baseline right bundle branch block and depth of THV implantation independently predicted the need of PPI.

The independent impact of dementia in patients undergoing percutaneous coronary intervention for acute myocardial infarction.

BACKGROUND: Although age and frailty are associated with worse prognoses for patients who undergo percutaneous coronary intervention (PCI), little is known regarding the independent impact of dementia. HYPOTHESIS: The aim of this study was to evaluate the association between dementia and outcomes for patients with acute myocardial infarction (AMI). METHODS: Consecutive patients with ST-elevation or non-ST elevation MI who had undergone PCI as part of our AMI registry were included in this study. We compared outcomes within the 1-year period of their PCI, including death and major adverse cardiac events (MACE) and corrected for confounders using Cox regression. RESULTS: Of 28 274 patients, 9167 patients who had undergone PCI for AMI were included in this study, 250 with dementia; Mean age (77.4 ± 9.4 in the dementia group vs. 63.6 ± 12.7 in the control), female gender (32.4 vs. 24.2%, p = .003), diabetes mellitus (54.0 vs. 42.4%, p < .001) and chronic kidney disease (44.4 vs. 19.3%, p < .001) were higher. At 12 months, unadjusted rates of death (25.5 vs. 9.8%, p < .001) and MACE (33.8 vs. 17.6%, p < .001) were higher for patients with dementia. After standardizing for confounding variables, dementia remained an independent risk factor for death (HR 1.90; CI 1.37-2.65; p < .001) and MACE (HR 1.73; CI 1.30-2.31; p < .001), as well as in propensity score matched analysis (HR 1.54; CI: 1.03-2.28; p < .001 and HR 1.49; CI: 1.09-2.02; p < .001, respectively). CONCLUSIONS: Dementia is an independent predictor of worse outcomes in patients undergoing PCI for AMI. Future intervention and specialized healthcare measures to mitigate this risk is warranted.

Transcatheter Interventions for Atrioventricular Dysfunction in Patients with Adult Congenital Heart Disease: An International Case Series.

INTRODUCTION: A substantial proportion of patients with adult congenital heart disease (ACHD) suffer from worsening valvular dysfunction in adulthood. Transcatheter valve interventions can offer a therapeutic alternative to surgery for those at high surgical risk. There is emerging but limited data on transcatheter interventions for atrioventricular (AV) valve dysfunction in patients with ACHD. METHODS: We compiled an international collaborative multi-center registry focusing on adult patients with congenital heart disease undergoing transcatheter AV valve interventions (repair or replacement). Included were patients from three international centers who underwent procedures between 2016 and 2022. Demographic, clinical, and procedural data were compiled. RESULTS: Nine patients with ACHD underwent AV valve interventions. The median age was 48 years (IQR (37; 56), 55% women). At baseline, seven patients (78%) were in NYHA functional class III and two (22%) were in NYHA functional class II. The diagnosis of ACHD varied. Three valve interventions were performed on the subpulmonary AV valve and six on the systemic AV valve. The primary valvular pathology was regurgitation (six patients, 78%). Five procedures were valve-in-valve interventions, and four procedures were transcatheter edge-to-edge repair procedures. There were no major complications or peri-procedural complications or peri-procedural mortality. One patient developed a suspected non-obstructive thrombus on the valve that was medically treated. One patient did not improve clinically following the procedure and underwent a heart transplant, one patient died 6 months following the procedure due to a cardiovascular implantable electronic device infection. At one year, six patients were in NYHA functional class I, and one patient was in NYHA functional class III. In conclusion, transcatheter AV heart valve interventions are feasible and safe procedures in carefully selected ACHD patients. These procedures can offer an effective treatment option in these younger patients with high surgical risk.

Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices.

BACKGROUND: The ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR). AIMS: We sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices. METHODS: The NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification. RESULTS: A total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p>0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p<0.001). CONCLUSIONS: This retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.

Hypothyroidism predicts worsened prognosis in patients undergoing percutaneous coronary intervention.

Background: The link between thyroid dysfunction and cardiovascular disease is well established. Hypothyroidism has been significantly associated with increased risk of dyslipidemia, atherosclerosis and heart failure. However, little is known regarding its effect on patients undergoing percutaneous coronary intervention (PCI). Aim: The aim of study was to examine the impact of concomitant hypothyroidism on mortality and major adverse cardiac event (MACE) in patients undergoing PCI. Methods: The Rabin Medical Center PCI registry includes all consecutive patients who have undergone PCI between 2004 and 2020. We identified patients with prior diagnosis of hypothyroidism, and compared rates of mortality and MACE (comprising death, myocardial infarction, target vessel revascularization and/or coronary bypass surgery). Results: Among 28,274 patients, 1,922 (6.8%) were found to have hypothryoidism. These patients were older (70.3 ± 10.4 vs. 66.0 ± 11.8 y.o, P < 0.001) and more likely to be women (34.2% vs. 26.1%, P < 0.001). They had a higher prevalence of atrial fibrillation (10.8% vs. 7.7%, P < 0.001), chronic renal dysfunction (25.1% vs. 18.7%, P = 0.04) and dementia (2.9% vs. 1.8%, P = 0.004). PCI was performed on ACS setting in 52-54% of patients in both groups (p = 0.569). Unadjusted 5-year rates of all-cause mortality (26.9% vs. 20.3%, P < 0.001) and MACE (40.3% vs. 29.4%, P < 0.001) were higher for hypothyroid patients. A propensity match score was able to form 672 matched pairs of HT and control patients, showing similar results. Moreover, following multivariate analysis, TSH as a continuous parameter was associated with a higher risk of mortality and MACE (HR, 1.06 per additional 1 mIU/L; CI, 1.02-1.11; P < 0.001 and HR, 1.07; CI, 1.02-1.12; P < 0.001, respectively) at 5-year follow up. Conclusion: In our study, hypothyroidism confers worse outcomes in patients undergoing PCI. Further research is needed to establish effective ways to mitigate this augmented risk.

Reticulated Platelets and Their Relationship with Endothelial Progenitor Cells during the Acute Phase of ST-Elevation Myocardial Infarction.

Introduction: Endothelial progenitor cells (EPC) and reticulated platelets (RP) have central roles in the thrombotic and angiogenetic interactions during ST-elevation myocardial infarction (STEMI). The EPC and RP response in patients with STEMI treated by primary percutaneous intervention (PPCI) has not yet been investigated. Methods: We assessed EPC quantification by the expression of CD133+ and CD34+, and EPC function by the capacity of the cells to form colony-forming units (CFU) and MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide) during the acute phase of STEMI. These measurements were correlated with RP at baseline and after 24 h following PPCI. Results: Our cohort included 89 consecutive STEMI-diagnosed patients enrolled between December 2018 and July 2021. At baseline, there was a strong positive correlation between reticulated platelet quantity and MTT levels (R = 0.766 and R2 = 0.586, p < 0.001), CD34+ levels (R = 0.602, and R2 = 0.362, p < 0.001); CD133+ levels (R = 0.666 and R2 = 0.443, p < 0.001) and CFU levels (R = 0.437, R2 = 0.191, p < 0.001). The multiple linear regression showed that levels of MTT (adjusted R2 = 0.793; p < 0.001), CD34+ and CD133+ (adjusted R2 = 0.654; p < 0.001 and adjusted R2 = 0.627; p < 0.001, respectively) had strong independent correlations with RP response. At 24 h after PPCI, the correlation between RP quantity and EPC markers was not significant, except for MTT levels (R = 0.465, R2 = 0.216, p < 0.001). Conclusions: In patients with STEMI, higher levels of RP at baseline are significantly correlated with a more potent EPC response. The translational significance of these findings needs further investigation.

Outcomes of Transcatheter Edge-to-Edge Repair in Degenerative vs. Functional Mitral Regurgitation.

Current guidelines support the use of transcatheter edge-to-edge repair (TEER) for patients with both primary and secondary mitral regurgitation. We aimed to compare the prognoses of TEER in degenerative mitral regurgitation (DMR) vs. functional mitral regurgitation (FMR). A total of 208 consecutive patients who underwent TEER over a ten-year period were analyzed. Primary endpoints included rates of all-cause death and major adverse cardiac events (MACE: composite of all-cause death, hospitalizations for heart failure, mitral valve surgery, or TEER re-intervention). A total of 148 (71%) patients were identified with FMR, while 60 (29%) were identified with DMR. Patients in the FMR group were younger (77.2 ± 8.4 vs. 80.2 ± 7.2, p = 0.02), suffered more frequently from coronary artery disease (54.1% vs. 10.0%, p = 0.02), and atrial fibrillation/flutter (70.9% vs. 38.3%, p = 0.02). Rates of 1-year death (21.6% vs. 10.0%, p = 0.03) and MACE (41.2% vs. 21.7%, p = 0.02) were higher for the FMR group, as compared to the DMR group. After correcting for variables, FMR independently predicted rates of MACE (HR-1.78, 95% CI 1.23-2.48, p = 0.04) and had a non-significant effect on one-year mortality (HR-1.67, 95%CI 0.98-3.74, p = 0.07). In our experience, worse overall 1-year composite MACE outcomes were observed after TEER in patients with FMR as compared to patients with DMR.

Management and Outcome of Acute Ischemic Stroke Complicating Transcatheter Aortic Valve Replacement.

BACKGROUND: Despite advances in transcatheter aortic valve replacement (TAVR), periprocedural acute ischemic stroke remains a concern. OBJECTIVES: The aims of this study were to investigate acute ischemic stroke complicating TAVR (AISCT) and to describe the indications and outcomes of interventions to treat AISCT. METHODS: An international multicenter registry was established focusing on AISCT within 30 days of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale. Primary outcomes were 1-year all-cause death and neurologic disability status at 90 days according to modified Rankin scale score. RESULTS: Of 16,615 TAVR procedures, 387 patients with AISCT were included (2.3%). Rates of 1-year death were 28.9%, 35.9%, and 77.5% in patients with mild, moderate, and severe stroke, respectively (P < 0.001). Although 348 patients were managed conservatively, 39 patients (10.1%) underwent neurointervention (NI) with either mechanical thrombectomy (n = 26) or thrombolytic therapy (n = 13). In a subanalysis excluding patients with mild stroke, there was no clear 1-year survival benefit for NI compared with conservative management (47.6% vs 41.1%, respectively; P = 0.78). In a logistic regression model controlling for stroke severity, NI was associated with 2.9-fold odds (95% CI: 1.2-7.0; P = 0.016) of independent survival at 90 days. CONCLUSIONS: AISCT carries significant morbidity and mortality, which is correlated with stroke severity. The present findings suggest that neurologic disability for patients with moderate or worse stroke could potentially be improved by timely intervention and highlight the importance of collaboration between cardiologists and neurologists to optimize AISCT outcomes.

Temporal Trends in Complex Percutaneous Coronary Interventions.

Background: Accumulated experience combined with technological advancements in percutaneous coronary interventions (PCI) over the past four decades, has led to a gradual increase in PCI utilization and complexity. We aimed to investigate the temporal trends in PCI complexity and the outcomes of complex PCI (C-PCI) in our institution. Methods: We analyzed 20,301 consecutive PCI procedures performed over a 12-year period. C-PCI was defined as a procedure involving at least one of the following: Chronic total occlusion (CTO), left main (LM), bifurcation or saphenous vein graft (SVG) PCI. Four periods of 3-year time intervals were defined (2008-10, 2011-2013, 2014-2016, 2017-2019), and temporal trends in the rate and outcomes of C-PCI within these intervals were studied. Endpoints included mortality and major adverse cardiac events [MACE: death, acute myocardial infarction (MI), and target vessel revascularization (TVR)] at 1 year. Results: A total of 5,647 (27.8%) C-PCI procedures were performed. The rate of C-PCI has risen significantly since 2,017 (31.2%, p < 0.01), driven mainly by bifurcation and LM interventions (p < 0.01). At 1-year, rates of death, acute MI, TVR and MACE, were all significantly higher in the C-PCI group (8.8 vs. 5.1%, 5.6 vs. 4.5%, 5.5 vs. 4.0%, 17.2 vs. 12.2%, p < 0.001 for all, respectively), as compared to the non-complex group. C-PCI preformed in the latter half of the study period (2014-2019) were associated with improved 1-year TVR (4.4% and 4.8% vs. 6.7% and 7.1%, p = 0.01, respectively) and MACE (13.8% and 13.5% vs. 17.3% and 18.2%, p = 0.001, respectively) rates compared to the earlier period (2007-2013). Death rate had not significantly declined with time. Conclusion: In the current cohort, we have detected a temporal increase in PCI complexity coupled with improved 1-year clinical outcomes in C-PCI.

Local Anesthesia versus Conscious Sedation among Patients Undergoing Transcatheter Aortic Valve Implantation-A Propensity Score Analysis.

BACKGROUND: Conscious sedation (CS) has been used successfully to treat patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) and as such is considered the standard anesthesia method. The local anesthesia (LA) only approach may be feasible and safe thanks to improvements in operators' experience. OBJECTIVE: To evaluate differences between LA only versus CS approaches on short- and long-term outcomes among patients undergoing TAVI. METHODS: We performed a propensity score analysis on 1096 patients undergoing TAVI for severe AS. Two hundred and seventy-four patients in the LA group were matched in a ratio of 1:3 with 822 patients in the CS group. The primary outcome was a 1-year mortality rate. Secondary outcomes included procedural and peri-procedural complication rates and in-hospital mortality. RESULTS: Patients in the CS group had significantly higher rates of grade 2-3 acute kidney injury and were more likely to have had new left bundle branch block and high-degree atrioventricular block. Patients who underwent TAVI under CS had significantly higher in-hospital and 1-year mortality rates compared to LA (1.6% vs. 0.0% p-value = 0.036 and 8.5% vs. 3.3% p-value = 0.004, respectively). Kaplan-Meier's survival analysis showed that the cumulative probability of 1-year mortality was significantly higher among subjects undergoing CS compared to patients LA (p-value log-rank = 0.024). Regression analysis indicated that patients undergoing CS were twice more likely to die of at 1-year when compared to patients under LA (HR 2.18, 95%CI 1.09-4.36, p-value = 0.028). CONCLUSIONS: As compared to CS, the LA-only approach is associated with lower rates of peri-procedural complications and 1-year mortality rates.

Tricuspid Structural Valve Deterioration Treated with a Transcatheter Valve-in-Valve Implantation: A Single-Center Prospective Registry.

The valve-in-valve (ViV) technique is an emerging alternative for the treatment of bioprosthetic structural valve deterioration (SVD) in the tricuspid position. We report on the outcomes of patients treated by a transcatheter tricuspid valve-in-valve (TT-ViV) implantation for symptomatic SVD in the tricuspid position during the years 2010-2019 at our center. Three main outcomes were examined during the follow-up period: TT-ViV hemodynamic data per echocardiography, mortality and NYHA functional class. Our cohort consisted of 12 patients with a mean age 65.4 ± 11.9 years, 83.3% male. The mean time from initial valve intervention to TT-ViV was 17.4 ± 8.7 years. The indications for TT-ViV were varied (41.7% for predominant regurgitation, 33.3% for predominant stenosis and 25.0% with a mixed pathology). All patients were treated with a balloon-expandable device. The mean follow-up was 3.4 ± 1.3 years. Tricuspid regurgitation was ≥ moderate in 57.2% of patients prior to the procedure and this decreased to 0% following the procedure. The mean transtricuspid valve gradients mildly decreased from the mean pre-procedural values of 9.0 mmHg to 7.0 mmHg at one month following the procedure (p = 0.36). Mortality at one year was 8.0% (95% CI 0-23). At the baseline, 4 patients (33.3%) were in NYHA functional class III/IV; this was reduced to 2 patients (18.2%) at the one year follow-up and both were in NYHA III. The TT-ViV procedure offered a safe, feasible and less invasive treatment option for patients with SVD in our detailed cohort.

Preoperative evaluation of pulmonary hypertension in lung transplant candidates: echocardiography versus right heart catheterization.

BACKGROUND: Right heart catheterization (RHC) and echocardiography are both routinely used for pulmonary artery systolic pressure (PASP) assessment in lung transplantation (LT) candidates, although this is not mandated by current guidelines. We aimed to explore the performance of echocardiographic PASP as an indicator of pulmonary hypertension in LT candidates, in order to assess the necessity of RHC. METHODS: From a retrospective registry of 393 LT candidates undergoing RHC and echocardiography during 2015-2019, patients were assessed for the presence of pulmonary hypertension (PH), defined as mean pulmonary artery pressure (mPAP) above 20 mmHg, according to two methods-echocardiography and RHC. The primary outcome was the correlation between the PASP estimated by echocardiography to that measured by RHC. Secondary outcomes were the prediction value of the echocardiographic evaluation and its accuracy. RESULTS: The mean value of PASP estimated by echocardiography was 49.5 ± 20.0 mmHg, compared to 42.5 ± 18.0 mmHg measured by RHC. The correlation between the two measurements was moderate (Pearson's correlation: r = 0.609, p < 0.01). Echocardiography PASP measurements were moderately discriminative to diagnose PH, with an area under the curve (AUC) of 0.72 (95% CI 0.66-0.77). Echocardiographic overestimation of PASP of more than 10 mmHg was found in 35.0% of the patients, and underestimation was found in 11.6% of the patients. CONCLUSION: In the pre-surgical evaluation of LT candidates, echocardiographic estimation of PASP had moderate correlation and limited accuracy compared to the PASP measured by RHC. We thus recommend performing routine RHC to all LT candidates, regardless of the echocardiographic estimation of PASP.