Gender-Dependent Association of Pulmonary Hypertension with Adverse Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement.

Background: The relationship between pulmonary hypertension (PH) and outcomes after transcatheter aortic valve replacement (TAVR) has been shown to be unfavorable. The impact of gender on TAVR outcomes remains controversial. There have been no studies evaluating the simultaneous effects of both factors on TAVR outcomes. Methods: We retrospectively analyzed a prospective cohort of patients who underwent TAVR between January 2016 and December 2022. The patients were stratified by gender and the presence of PH. The primary outcome of the study was all-cause mortality. Secondary outcome was a composite of all-cause mortality and heart failure hospitalization. Results: We identified a total of 133 female patients without PH, 179 males without PH, 87 females with PH, and 122 males with PH. The median follow-up period was 18 months. Female patients without PH demonstrated a lower cumulative mortality rate compared to those with male gender and/or PH. Adjusted multivariate Cox proportional hazard analyses revealed that male gender and PH status, either individually or in combination, were independently associated with long-term mortality when compared to female patients without PH. Specifically, females with PH (HR 6.80, 95% confidence interval (CI): 1.49-31.12, P=0.013), males without PH (HR 6.45, 95% CI: 1.47-28.22, P=0.013), and males with PH (HR 7.2, 95% CI: 1.63-31.81, P=0.009) demonstrated significantly higher risk for mortality. Conclusion: Patients who were male or had PH status had a higher risk of mortality. However, there was no synergistic effect between being male and having PH on the prognosis after TAVR.

Recent advancements in polymeric heart valves: From basic research to clinical trials.

Valvular heart diseases (VHDs) have become one of the most prevalent heart diseases worldwide, and prosthetic valve replacement is one of the effective treatments. With the fast development of minimal invasive technology, transcatheter valves replacement has been exploring in recent years, such as transcatheter aortic valve replacement (TAVR) technology. In addition, basic research on prosthetic valves has begun to shift from traditional mechanical valves and biological valves to the development of polymeric heart valves. The polymeric heart valves (PHVs) have shown a bright future due to their advantages of longer durability, better biocompatibility and reduced cost. This review gives a brief history of the development of polymeric heart valves, provides a summary of the types of polymer materials suitable for heart leaflets and the emerging processing/preparation methods for polymeric heart valves in the basic research. Besides, we facilitate a deeper understanding of polymeric heart valve products that are currently in preclinical/clinical studies, also summary the limitations of the present researches as well as the future development trends. Hence, this review will provide a holistic understanding for researchers working in the field of prosthetic valves, and will offer ideas for the design and research of valves with better durability and biocompatibility.

Usefulness of frailty assessment using the revised Japanese version of the Cardiovascular Health Study on the prediction of clinical outcomes in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

Frailty assessment is essential for deciding the treatment strategy for patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). Recently, the revised Japanese version of the Cardiovascular Health Study (J-CHS) criteria has been proposed for the frailty assessment; however, it is unclear whether the criteria are useful for the risk stratification in these patients. We investigated the impact of frailty assessment using the revised J-CHS criteria on clinical outcomes in patients with AS undergoing TAVR. We examined 205 consecutive severe AS patients who underwent TAVR at two tertiary hospitals from May 2018 to December 2022. Frailty was defined by the revised J-CHS criteria (score ≥ 3) before TAVR. The primary outcome was major adverse cardiac or cerebrovascular events (MACCE). Among the studied patients, the mean age was 84 years and 65% were female. Frailty was present in 51% of patients. During a median follow-up period of 1000 (interquartile range 677-1210) days, MACCE occurred in 22 patients. Frailty was significantly independently associated with higher risks of the MACCE adjusted for confounders related to nutritional status, severity of AS, comorbidities [hazard ratio (HR) 5.09, 95% confidence interval (CI) 1.70-15.23; HR 3.94, 95% CI 1.34-11.55; HR 3.12, 95% CI 1.14-8.53; HR 3.31, 95% CI 1.21-9.02, respectively]. Frailty determined by the revised J-CHS criteria was associated with clinical outcomes, suggesting these criteria would be useful for risk stratification in Japanese patients with AS undergoing TAVR.

First-in-human: Leaflet laceration with balloon mediated annihilation to prevent coronary obstruction with radiofrequency needle (LLAMACORN) for valve-in-valve transcatheter aortic valve replacement.

Coronary obstruction (CO) is a potential pitfall for transcatheter aortic valve replacement (TAVR), especially in valve in valve procedures into degenerated surgical or transcatheter prostheses. Bioprosthetic leaflet modification techniques that incorporate electrosurgery are evolving as the preferred strategy to mitigate the risk of CO in high CO risk settings. The UNICORN method is proposed as a more predictable leaflet modification strategy than the earlier described BASILICA approach, but its proponents have hitherto mandated the use of a balloon-expandable valve (BEV) prosthesis. Many patients have small prostheses and therein face a significant risk of patient prosthesis mismatch with BEV in this setting. This risk may be curtailed if a self-expanding valve (SEV) prosthesis could be used. Herein described is a modified approach to allow for the utilization of SEV systems in this setting.

Five-year outcomes of measured and predicted prosthesis-patient mismatch following transcatheter aortic valve implantation.

BACKGROUND: Data on the long-term outcomes of prosthesis-patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) remain controversial. OBJECTIVES: The aim of this study was to investigate the incidence and clinical outcomes of measured PPM (PPMM) and predicted PPM (PPMP) in patients undergoing TAVI. METHODS: This is a retrospective analysis of 3,016 patients who underwent TAVI at a large Healthcare System between 2012 and 2021. Effective orifice area indexed to body surface area (EOAi) was measured at discharge using the continuity equation. EOAi was predicted according to the published predictive tables for each model and size of the valve. Primary endpoint was 5-year survival rate. RESULTS: Mean age was 80 years and 55.6% were male. The mean STS risk score was 4.66%. 74.9% of patients received a BEV and 25.1% received a SEV. The incidence of severe PPM was markedly lower when defined by predicted vs. measured EOAi (0.8% vs. 6.3%, P < 0.001) and when assessed in SEV vs. BEV (5.3% vs. 6.6%, p= 0.02). Neither severe PPMp nor severe PPMM was associated with 5-year mortality (HR=1.26, 95% CI= 0.96-1.66, p=0.095; HR=1.03, 95% CI= 0.42-2.49, p=0.954, respectively), irrespective of the presence of high residual pressure gradient. Neither BEV nor SEV was associated with an increased 5-year mortality, irrespective of PPM definition or severity. CONCLUSIONS: In this large healthcare system analysis, neither severe PPMP nor severe PPMM was associated with five-year all-cause mortality. There was no difference between BEV and SEV in terms of mortality, irrespective of the definition or severity of PPM.

Hypercapnia during transcatheter aortic valve replacement under monitored anaesthesia care: a retrospective cohort study.

BACKGROUND: Acute intraoperative hypercapnia and respiratory acidosis, which can occur during monitored anaesthesia care (MAC), pose significant cardiopulmonary risks for patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). The goal of the present study is to assess the incidence, risk factors and impact of intraoperative hypercapnia during MAC for patients undergoing transfemoral TAVR. METHODS: Data was collected retrospectively from the electronic medical record of 201 consecutive patients with available intraoperative arterial blood gas (ABG) data who underwent percutaneous transfemoral TAVR with MAC using propofol and dexmedetomidine. ABGs (pH, arterial partial pressure of carbon dioxide (PaCO2) and arterial partial pressure of oxygen) were performed at the start of each case (baseline), immediately prior to valve deployment (ValveDepl), and on arrival to the postanaesthesia care unit. Data was analysed using Fisher's exact test, unpaired Student's t-test, Wilcoxon rank sum or univariate linear regression as appropriate based on PaCO2 and pH during ValveDepl (PaCO2-ValveDepl, pH-ValveDepl) and change in PaCO2 and pH from baseline to ValveDepl (PaCO2-%increase, pH-%decrease) to determine their association with preoperative demographic data, intraoperative anaesthetic and vasoactive medications and postoperative outcomes. RESULTS: PaCO2 increased by a mean of 28.4% and was higher than baseline in 91% of patients. Younger age, male sex, increased weight and increased propofol dose contributed to higher PaCO2-ValveDepl and greater PaCO2-%increase. Patients with PaCO2-ValveDepl>60 mm Hg, pH≤7.2 and greater pH-%decrease were more likely to receive vasoactive medications, but perioperative PaCO2 and pH were not associated with adverse postoperative outcomes. CONCLUSIONS: Transient significant hypercapnia commonly occurs during transfemoral TAVR with deep sedation using propofol and dexmedetomidine. Although the incidence of postoperative outcomes does not appear to be affected by hypercapnia, the need for vasopressors and inotropes is increased. If deep sedation is required for TAVR, hypercapnia and the need for haemodynamic and ventilatory support should be anticipated.

Trends in Complications Among Patients Undergoing Aortic Valve Replacement in the United States.

BACKGROUND: The treatment of severe aortic stenosis has evolved considerably since the introduction of transcatheter aortic valve replacement (TAVR), yet trends in complications for patients undergoing TAVR or surgical aortic valve replacement (SAVR) at a national level have yet to be evaluated. METHODS AND RESULTS: We performed a retrospective cohort study using Medicare data to evaluate temporal trends in complications among beneficiaries, aged ≥65 years, treated with elective isolated transfemoral TAVR or SAVR between 2012 and 2019. The study end point was the occurrence of a major complication (composite outcome) during index and up to 30 days after. Multivariable logistic regression was used to assess odds of complications for TAVR and SAVR, individually over time, and for TAVR versus SAVR, over time. The cohort included 211 212 patients (mean±SD age, 78.6±7.3 years; 45.0% women). Complication rates during index following elective isolated aortic valve replacement decreased from 49% in 2012 to 22% in 2019. These reductions were more pronounced for TAVR (41% to >19%, Δ=22%) than SAVR (51% to >47%, Δ=4%). After risk adjustment, the risk of any complication with TAVR was 47% (P<0.0001) lower compared with SAVR in 2012, and 78% (P<0.0001) lower in 2019. TAVR was independently associated with reduced odds of complications each year compared with 2012, with the magnitude of benefit increasing over time (2013 versus 2012: odds ratio [OR], 0.89 [95% CI, 0.81-0.97]; 2019 versus 2012: OR, 0.35 [95% CI, 0.33-0.38]). These findings are consistent for complications up to 30 days from index. CONCLUSIONS: Between 2012 and 2019, the risk of complications after aortic valve replacement among Medicare beneficiaries decreased significantly, with larger absolute and relative changes among patients treated with TAVR than SAVR.

Cerebrovascular Events in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Pooled Patient-Level Study.

BACKGROUND: Cerebrovascular events remain one of the most devastating complications of transcatheter aortic valve implantation (TAVI). Data from real-world contemporary cohorts on longitudinal trends and outcomes remain limited. The aim of this study was to assess incidence, temporal trends, predictors, and outcomes of cerebrovascular events following transfemoral TAVI. METHODS AND RESULTS: The CENTER2 (Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Implantation With Balloon-Expandable Valves Versus Self-Expandable Valves 2) study includes patients undergoing TAVI between 2007 and 2022. The database contains pooled patient-level data from 10 clinical studies. A total of 24 305 patients underwent transfemoral TAVI (mean age 81.5±6.7 years, 56% women, median Society of Thoracic Surgeon Predicted Risk of Mortality 4.9% [3.1%-8.5%]). Of these patients, 2.2% (n=534) experienced stroke in the first 30 days after TAVI, and 40 (0.4%) had a transient ischemic attack. Stroke rates remained stable during the treatment period (2007-2010: 2.1%, 2011-2014: 2.5%, 2015-2018: 2.1%, 2019-2022: 2.1%; Ptrend=0.28). Moreover, 30-day cerebrovascular event rates were similar across Society of Thoracic Surgeon Predicted Risk of Mortality risk categories: 2.1% in low-risk, 2.6% in intermediate-risk, and 2.5% in high-risk patients (P=0.21). Mortality was higher in patients with 30-day stroke than without at 30 days (20.3% versus 4.7%; odds ratio, 5.1 [95% CI, 4.1-6.5]; P<0.001) and at 1 year (44.1% versus 15.0%; hazard ratio, 3.5 [95% CI, 3.0-4.2]; P<0.001). One-year mortality rates for stroke did not decline over time (2007-2010: 46.9%, 2011-2014: 46.0%, 2015-2018: 43.0%, 2019-2022: 39.1%; Ptrend=0.32). At 1 year, 7.0% of patients undergoing TAVI had a stroke. CONCLUSIONS: In 24 305 patients who underwent transfemoral TAVI, 30-day cerebrovascular event incidence remained ≈ 2.2% between 2007 and 2022. Thirty-day stroke rates were similar throughout Society of Thoracic Surgeon Predicted Risk of Mortality risk categories. Mortality rates after stroke remain high. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03588247.

Rupture of the ascending aorta 6 months after TAVI procedure caused by TAVI prosthesis.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is indicated for elderly patients who often have severe comorbidities and high operative risk. Despite many advantages, it carries the potential for both early and late complications. The literature reports mainly periprocedural problems. This case report describes a rare instance of ascending aortic rupture as a late complication following TAVI. CASE PRESENTATION: An 81-year-old male with severe aortic stenosis (AS) was a non-surgical patient due to a high operative risk (EuroSCORE II 14.08%) and comorbidities, including cardiovascular problems, chronic obstructive pulmonary disease, myelodysplastic syndrome. During the TAVI procedure Medtronic CoreValve™ Evolut™ R-26 was implanted via the right femoral artery. Postoperative period elapsed without complications and the patient was discharged home. Six months later, the patient was re-admitted to the hospital on an emergency basis and transferred directly to the operating room due to ascending aortic rupture (EuroSCORE II 53.20%, GERAADA score 64.9%). Computed tomography angiography (CTA) showed aortic rupture with a multiple fresh blood reservoirs and thrombus around the ascending aorta originating from the spot where the nitinol frame of the TAVI valve was attached to the native aorta. Supracoronary excision of the ascending aorta with implantation of a vascular graft (Intergard Woven Graft 34 mm) was performed, preserving the earlier implanted TAVI valve. On the 9th day after surgery the patient's general condition deteriorated, he suffered from circulatory and respiratory insufficiency. Furthermore, a gastrointestinal bleeding with the need for gastro-, and colonoscopy and multiple blood transfusions occurred. Patient developed urosepsis and acute renal failure with the need for hemodiafiltration. Despite intensive treatment, further deterioration of the medical condition of the patient. and finally the multiple organ failure was observed. Patient died on the 50th postoperative day. CONCLUSIONS: TAVI is a safe method of treating severe AS, especially recommended for non-surgical candidates. Rupture of the ascending aorta is a rare but serious complication of TAVI that usually occur during or shortly after the procedure. This case report highlights the importance of post-procedural monitoring for such TAVI complications, even in the late period following TAVI, and if such complications occur, taking the risk to perform a life-saving operation.

Impact of cerebral protection on observed versus predicted in-hospital stroke in a high stroke risk TAVR cohort.

BACKGROUND: Despite impressive improvements in the safety profile of Transcatheter aortic valve replacement (TAVR), the risk for peri-procedural stroke after TAVR has not declined substantially. In an effort to reduce periprocedural stroke, cerebral embolic protection (CEP) devices have been utilized but have yet to demonstrate benefit in all-comers. There is a paucity of data supporting the utilization of CEP in TAVR patients with an anticipated high risk for peri-procedural stroke. METHODS: The Transcatheter Aortic Valve Replacement In-Hospital Stroke (TASK) score is a clinical risk tool for predicting the in-hospital stroke risk of patients undergoing transfemoral TAVR. This score was used to identify high-risk patients and calculate the expected in-hospital stroke risk. This was a single-centre cohort study in all consecutive TAVR patients who had placement of CEP. The observed versus expected ratio for peri-procedural stroke was calculated. To obtain 95% credible intervals, we used 1000 bootstrapped samples of the original cohort sample size without replacement and recalculated the TASK predicted scores. RESULTS: The study included 103 patients. The median age was 83 (IQR 78,89). 63 were male (61.1%) and 45 (43.69%) had a history of previous Stroke or TIA. Two patients had an in-hospital stroke after TAVR (1.94%). The expected risk of in-hospital stroke based on the TASK score was 3.39% (95% CI 3.07-3.73). The observed versus expected ratio was 0.57 (95% CI 0.52-0.64). CONCLUSION: In this single-center study, we found that in patients undergoing TAVR with high stroke risk, CEP reduced the in-hospital stroke risk by 43% when compared with the risk-score predicted rate. CLINICAL TRIAL NUMBER: N/A.

Association of Mitral Valve Geometry at CT with Secondary Mitral Regurgitation after Transcatheter Aortic Valve Replacement in Patients with Aortic Regurgitation.

Background: The improvement rate and predictors of secondary mitral regurgitation in patients with aortic regurgitation undergoing transcatheter aortic valve replacement (TAVR) remain unclear. This study aimed to identify predictors of persistent moderate to severe secondary mitral regurgitation after TAVR in patients with aortic regurgitation by assessing mitral valve geometry with computed tomography (CT). Methods: This retrospective cohort study reviewed 242 consecutive patients with aortic regurgitation who underwent TAVR between May 2014 and December 2022. Patients with primary or less than moderate mitral regurgitation were excluded. Mitral annular dimensions (area, perimeter, anteroposterior, intercommissural, and trigone-to-trigone diameter), mitral valve tenting geometry (mitral valve tenting area [MVTA] and mitral valve tenting height [MVTH]), and papillary muscle displacement were systematically measured at CT. Mitral regurgitation improvement was assessed at 3 months after TAVR by echocardiography. Logistic regression was performed to explore the association of mitral valve geometry with mitral regurgitation improvement after TAVR. Results: A total of 75 patients (mean age, 74 ± 7 years; 32.0% female) with moderate to severe secondary mitral regurgitation were included in the final analysis. Mitral regurgitation improved in 49 patients and remained unchanged in 26 patients. Mitral annular dimensions, including area, perimeter, anteroposterior, and intercommissural diameter, were associated with mitral regurgitation improvement. MVTA and MVTH were risk factors for sustained mitral regurgitation. In addition, QRS duration > 120 ms and atrial fibrillation had an impact on the mitral regurgitation improvement. Mitral annular area (odds ratio [OR], 1.41; 95% confidence interval [CI]: 1.05, 1.90; p = 0.02) and MVTA (OR, 7.24; 95% CI: 1.72, 30.44; p = 0.007) were independent predictors of persistent secondary mitral regurgitation after TAVR. Conclusions: Mitral annular area and MVTA were independent predictors of persistent secondary mitral regurgitation after TAVR.

Clinical Significance of Diffusion-Weighted Brain MRI Lesions After TAVR: Results of a Patient-Level Pooled Analysis.

BACKGROUND: Acute brain infarction detected by diffusion-weighted magnetic resonance imaging (DW-MRI) is common after transcatheter aortic valve replacement (TAVR), but its clinical relevance is uncertain. OBJECTIVES: The authors investigated the relationship between DW-MRI total lesion number (TLN), individual lesion volume (ILV), and total lesion volume (TLV) and clinical stroke outcomes after TAVR. METHODS: Patient-level data were pooled from 4 prospective TAVR embolic protection studies, with consistent predischarge DW-MRI acquisition and core laboratory analysis. C-statistic was used to determine the best DW-MRI measure associated with clinical stroke. RESULTS: A total of 495 of 603 patients undergoing TAVR completed the predischarge DW-MRI. At 30 days, the rate of clinical ischemic stroke was 6.9%. Acute ischemic brain injury was seen in 85% of patients with 5.5 ± 7.3 discrete lesions per patient, mean ILV of 78.2 ± 257.1 mm3, and mean TLV of 555 ± 1,039 mm3. The C-statistic was 0.84 for TLV, 0.81 for number of lesions, and 0.82 for maximum ILV in predicting ischemic stroke. On the basis of the TLV cutpoint as defined by receiver operating characteristic (ROC), patients with a TLV >500 mm3 (vs TLV ≤500 mm3) had more ischemic stroke (18.2% vs 2.3%; P < 0.0001), more disabling strokes (8.8% vs 0.9%; P < 0.0001), and less complete stroke recovery (44% vs 62.5%; P = 0.001) at 30 days. CONCLUSIONS: Our study confirms that the number, size, and total volume of acute brain infarction defined by DW-MRI are each associated with clinical ischemic strokes, disabling strokes, and worse stroke recovery in patients undergoing TAVR and may have value as surrogate outcomes in stroke prevention trials. (A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During TAVI [DEFLECT III]; NCT02070731) (A Study to Evaluate the Neuro-embolic Consequences of TAVR [NeuroTAVR]; NCT02073864) (The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation [REFLECT I]; NCT02536196) (The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation [REFLECT II]; NCT02536196).

Incidence, Predictors, and Prognostic Impact of Neurologic Events After TAVR According to VARC-3 Criteria.

BACKGROUND: The Valve Academic Research Consortium (VARC)-3 definition for neurologic events after transcatheter aortic valve replacement (TAVR) lacks clinical validation. OBJECTIVES: This study sought to determine the incidence, predictors, and clinical impact of neurologic events following TAVR as defined by VARC-3 criteria. METHODS: This was a multicenter study including 2,924 patients with severe aortic stenosis undergoing TAVR. Based on Neurologic Academic Research Consortium (NeuroARC) classification, neurologic events were classified as NeuroARC type 1 (stroke), NeuroARC type 2 (covert central nervous system injury), and NeuroARC type 3 (transient ischemic attack and delirium). Baseline, procedural, and follow-up data were prospectively collected in a dedicated database. RESULTS: After a median follow-up of 13 (7-37) months, neurologic events occurred in 471 patients (16.1%), NeuroARC type 1, 2, and 3 in 37.4%, 4.7%, and 58.0% of cases, respectively, and the majority (58.6%) were periprocedural. Advanced age, chronic kidney disease, atrial fibrillation, major vascular complications, and in-hospital bleeding determined an increased risk of periprocedural events (P < 0.03 for all). Neurologic events occurring during the periprocedural time frame were independently associated with a substantial increase in mortality at 1 year after the intervention (HR: 1.91; 95% CI: 1.23-2.97; P = 0.004). However, although NeuroARC type 1 was associated with an increased mortality risk (IRR: 3.38; 95% CI: 2.30-5.56; P < 0.001 and IRR: 21.7; 95% CI: 9.63-49.1; P < 0.001 for ischemic and hemorrhagic stroke, respectively), the occurrence of NeuroARC type 3 events had no impact on mortality. CONCLUSIONS: Neurologic events after TAVR were associated with poorer short- and long-term survival. This correlation was related to the type of NeuroARC event defined by the VARC-3 criteria. Given the negative impact on clinical outcomes, every attempt should be made to reduce the risk of neurologic complications after TAVR.

Contrast-Induced Encephalopathy Following Transcatheter Aortic Valve Replacement: A Case Series.

Contrast-induced encephalopathy (CIE) is an idiopathic reaction following iodine-contrast dye administration in patients undergoing angiographic procedures. While it has been well-documented following coronary and carotid interventions, literature on CIE following transcatheter aortic valve replacement is limited. We report the multidisciplinary management of 3 patients with CIE following transcatheter aortic valve replacement.

Transcarotid TAVR for Severe Bicuspid Aortic Stenosis With Virtually Atretic Coarctation of the Thoracic Aorta.

Transcatheter aortic valve replacement by alternate access sites allows for treatment of patients with unfavorable anatomy for a transfemoral approach. To our knowledge, we present the first reported case of successful transcatheter aortic valve replacement via the transcarotid approach in a 65-year-old man with a symptomatic severe bicuspid aortic valve stenosis and virtually atretic coarctation of the thoracic aorta.

Collagen-Based Bailout Compared to Suture-Mediated Vascular Closure Alone During Transcatheter Aortic Valve Replacement.

Background: Hemostasis for transfemoral transcatheter aortic valve replacement (TAVR) is typically achieved using a suture-mediated vascular closure device (VCD) prior to large-bore sheath insertion (preclosure technique). Recently, the addition of a hybrid closure technique using a preclose technique with the addition of a collagen-plug VCD after sheath removal in cases of failed hemostasis has been utilized. Methods: Data were collected from the Northwell TAVR registry, including 3 high-volume TAVR centers. We evaluated a preclose strategy with suture-mediated vascular closure alone ("legacy strategy") and standard bailout techniques versus a contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout. The primary end point was major or minor vascular complications as defined by the VARC-3 criteria. Results: A total of 1327 patients were included, of which 791 patients underwent TAVR with suture-mediated closure alone and 536 with contemporary strategy. The primary end point (major or minor vascular complication) was lower in the contemporary strategy (5.44% vs 1.31%; P < .001). Both minor (3.92% vs 1.12%; P = .002) and major (1.14% vs 0.19%; P = .0196) vascular complications were reduced and the total length of stay was less in the contemporary strategy (median of 3 days vs 2 days; P < .0001). Using multivariable analysis, we observed that vascular management strategy significantly improved the composite primary outcome when adjusted for sheath size, peripheral artery disease, carotid disease, and site of procedure. In the contemporary group, bailout collagen-plug VCD with an Angio-Seal (Terumo Medical) was used in 68 patients (12.69%) and bailout MANTA (Teleflex) was required in 4 patients (0.75%). There were no major or minor vascular complications among the patients who received bailout collagen-plug VCD. Conclusions: A contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout reduces the risk of vascular complications among patients undergoing transfemoral TAVR.

Neutrophil-to-lymphocyte ratio and prognostic nutritional index in predicting composite endpoint of early safety following transcatheter aortic valve replacement.

BACKGROUND: The incidence of composite endpoint of early safety (CEES) after transcatheter aortic valve replacement (TAVR) has been a topic of focus within the cardiovascular field due to its impact on long-term patient outcomes. Timely prophylactic interventions are crucial for patients identified as high risk for CEES through preoperative risk stratification. OBJECTIVES: This study aimed to explore the connection between inflammatory and nutritional markers, specifically the neutrophil-to-lymphocyte ratio (NLR) and prognostic nutritional index (PNI), and CEES occurrence. MATERIAL AND METHODS: A cohort of 134 patients undergoing TAVR in a single center was studied. The study endpoint was the occurrence of CEES, which was defined according to the Valve Academic Research Consortium 3. RESULTS: The CEES was reached in 25.4% of patients at 30 days. A high NLR was associated with a 5.55-fold increased risk of CEES (95% confidence interval (95% CI): 1.52-20.29; p < 0.05), while a low PNI was linked to a 4.43-fold increased risk (95% CI: 1.55-12.65; p < 0.01). Combining NLR and PNI provided additional risk stratification for high-risk patients (hazard ratio (HR), 95% CI: 2.24-43.37; p < 0.005). CONCLUSIONS: A high NLR and low PNI were shown to be significant predictors of CEES following TAVR. These findings underscore the significance of NLR and PNI in the risk assessment of TAVR patients, offering valuable insights for preventive measures.