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Background: Aortic valve lithotripsy can fragment aortic valve calcium deposits and potentially restore leaflet pliability in animal model and ex-vivo, but clinical data is limited. Transcatheter aortic valve implantation (TAVR) might not be feasible as an urgent procedure in critically ill patients. Balloon valvuloplasty has the major limitation of valve recoil and inducing aortic regurgitation., Aims: To determine the clinical feasibility of aortic valve lithotripsy-facilitated balloon valvuloplasty in patients with severe aortic stenosis unsuitable for valvular replacement., Methods: We performed lithotripsy as adjunctive therapy to balloon aortic valvuloplasty in ten consecutive patients, most of whom were deemed unfit for TAVR. Lithotripsy of the aortic valve was performed with simultaneous inflation of one to three peripheral lithotripsy balloons to deliver ultrasound pulses. Rapid pacing was not used during lithotripsy. Aortic valve velocity, gradient, and valve area were measured before and after the procedure by echocardiogram. Transvalvular pressure gradient was recorded intra-procedurally. Periprocedural and ninety-day clinical outcomes were followed., Results: Procedure was technically successful in 9 out of 10 patients and aborted in one patient due to cardiogenic shock. One patient had femoral closure device related complication. There was a statistically significant decrease in valvular gradient and increase in aortic valve area. 9 out of 10 patients recovered from acute episode and were discharged. 6 patients had improvement in NYHA class. 4 patients were subsequently able to receive TAVR. 90-day mortality occurred in 3 patients. There was no stroke or bradyarrhythmia peri-procedurally and no heart failure hospitalization at 90 days., Conclusion: Aortic valve lithotripsy-facilitated balloon valvuloplasty has reasonable feasibility, safety and technical reproducibility and acute clinical result. Hemodynamic effect is similar to that of balloon valvuloplasty reported in the literature. Subsequent Prognosis is not altered in critically ill patients., Competing Interests: Declaration of competing interest Dr. B. P. O'Neill is a consultant to and receives research support from Edwards Lifesciences. Dr. T. Frisoli is a proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr. D. D. Wang is a consultant for Edwards Lifesciences, Abbott, Neochord, and Boston Scientific and receives research grant support from Boston Scientific assigned to employer Henry Ford Health System. Dr. W. O'Neill has served as a consultant for Abiomed, Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and St. Jude Medical and serves on the Board of Directors of Neovasc Inc. Dr. P. A. Villablanca is a consultant for Edwards Lifesciences and Teleflex. The other authors had no conflicts to declare. The other authors have no potential conflict of interest to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Introduction: Patients with a small aortic annulus (SAA) undergoing aortic valve replacement are at increased risk of patient-prosthesis mismatch (PPM), which adversely affects outcomes. Transcatheter aortic valve replacement (TAVR) has shown promise in mitigating PPM compared to surgical aortic valve replacement (SAVR)., Methods: We conducted a systematic review and meta-analysis following PRISMA guidelines to compare clinical outcomes, mortality, and PPM between SAA patients undergoing TAVR and SAVR. Eligible studies were identified through comprehensive literature searches and assessed for quality and relevance., Results: Nine studies with a total of 2476 patients were included. There was no significant difference in 30-day Mortality between TAVR vs SAVR groups (OR = 0.65, 95% CI [ 0.09-4.61], P = 0.22). There was no difference between both groups regarding myocardial infarction at 30 days (OR = 0.63, 95% CI [0.1-3.89], P = 0.62). TAVR was associated with a significantly lower 30-day major bleeding and 2-year major bleeding, Pooled studies were homogeneous (OR = 0.44, 95% CI [0.31-0.64], P < 0.01, I2 = 0, P = 0.89), (OR = 0.4 ,95% CI [0.21-0.77], P = 0.03, I2 = 0%, P = 0.62) respectively. TAVR was associated with a lower rate of moderate PPM (OR = 0.6, 95% CI [ 0.44-0.84], p value = 0.01, i2 = 0%, p value = 0.44). The overall effect estimate did not favor any of the two groups regarding short-term Mild AR (OR = 5.44, 95% CI [1.02-28.91], P = 0.05) and Moderate/severe AR (OR = 4.08, 95% CI [ 0.79-21.02], P = 0.08, I2 = 0%, P = 0.59)., Conclusion: Our findings suggest that both TAVR and SAVR are viable options for treating AS in patients with a small aortic annulus. TAVR offers advantages in reducing PPM and major bleeding, while SAVR performs better in terms of pacemaker implantation. Future studies should focus on comparing newer generation TAVR techniques and devices with SAVR. Consideration of patient characteristics is crucial in selecting the optimal treatment approach for AS., Competing Interests: Declaration of competing interest Authors have nothing to disclose., (Copyright © 2024. Published by Elsevier B.V.)

Competing Interests: Funding Support and Author Disclosures Dr B. O’Neill is a consultant for Abbott, Edwards Lifesciences, and Medtronic; and has received research support from Edwards Lifesciences assigned to employer Henry Ford Health. Dr Wang is a consultant for Abbott, Boston Scientific, and Edwards Lifesciences; and has received research grant support from Boston Scientific assigned to her employer Henry Ford Health. Dr Frisoli is a clinical proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr W. O’Neill is a consultant for Abiomed, Medtronic, and Boston Scientific. Dr Villablanca is a consultant for Edwards Lifesciences and Teleflex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Competing Interests: Funding Support and Author Disclosures Dr B.P. O’Neill is a consultant to and receives research support from Edwards Lifesciences. Dr Frisoli is a proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr Wang is a consultant for Edwards Lifesciences, Abbott, Neochord, and Boston Scientific; and receives institutional research grant support from Boston Scientific. Dr W. O’Neill has served as a consultant for Abiomed, Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and St. Jude Medical; and serves on the board of directors of Neovasc Inc. Dr Villablanca is a consultant for Edwards Lifesciences and Teleflex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Competing Interests: Author Relationship With Industry The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Whether a volume-outcome relationship, that is, higher volume centres have better outcomes compared with lower volume hospitals, exists in transcatheter aortic valve implantation (TAVI) has not yet been systematically explored., Methods: We performed a systematic review and meta-analysis to evaluate whether highest or intermediate annual TAVI volume hospitals has better short-term (in-hospital or 30-days) mortality compared with the lowest volume hospitals. Odds ratio (OR) and 95% confidence interval (CI) was calculated with the Mantel-Haenszel method., Results: We identified 10 publications from nine different countries including TAVI performed between 2005-2017. Included patients were mainly high-risk cohorts. We included five and six studies to assess volume-outcome relationship in the highest and intermediate volume hospitals compared with the lowest volume hospitals, respectively. Our results showed that in both the highest (OR 0.66, 95%CI 0.53-0.83, p=0.0003, I 2 =78%) and intermediate (OR 0.85, 95%CI 0.79-0.92, p<0.0001, I 2 =0%) volume hospitals, there was a statistically significant volume-outcome relationship for short-term mortality compared with the lowest volume hospitals., Conclusions: Our review suggests a significant volume-outcome relationship post-TAVI in both the highest and intermediate volume hospitals compared with the lowest volume hospitals mainly in high surgical risk patients. The high heterogeneity in this relationship between the highest and the lowest volume hospitals warrant cautious interpretation. Whether this relationship remains significant in low-risk cohort requires further study., (Copyright © 2019 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

Ove the last decade, transcatheter aortic valve replacement (TAVR) has emerged as the recommended approach over surgical aortic valve replacement (SAVR) for many patients with aortic stenosis. While initial trials demonstrated a higher incidence of stroke with TAVR compared to SAVR, the incidence of stroke appears to have improved over time. With the increasing number of patients expected to undergo TAVR in the coming decades, it is important to review the incidence and etiology of stroke after SAVR and TAVR. Alterations in surgical technique for SAVR, and embolic protections devices for TAVR, have failed to demonstrate a clinically significant reduction in the incidence of post-procedural stroke. However, the definitions and assessment methods used for assessing stroke and neurological events varies among studies., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Aortic valve disease is a common condition whose prevalence is increasing, especially in Western countries. Two main families of cardiac prostheses are available: mechanical and biological prostheses. Nevertheless, the use of mechanical surgical valves has declined significantly over time in favor of bioprosthetic surgical valves even among middle-aged patients. The dominance of bioprosthetic valves was enhanced further with the introduction of transcatheter aortic valves. However, some concerns have arisen in recent years about clinical and subclinical leaflet thrombosis of both surgical and transcatheter bioprostheses. This manuscript aims to discuss the current evidence relating to the incidence, pathophysiology, clinical implications, and management strategies of biological valve leaflet thrombosis., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Transcatheter aortic valve implantation (TAVI) has been used to treat high surgical risk cohorts but has been expanded to treat low-to-intermediate risk cohort as well. We performed a systematic review and meta-analysis to compare the outcomes between TAVI and surgical aortic valve replacement (SAVR) in low-to-intermediate risk cohort. We queried PUBMED, EMBASE, and ClinicalTrial.gov for relevant articles. Randomized controlled trials that compared at least one of the outcomes of interest between TAVI and SAVR were included. Risk ratio (RR) and 95% confidence interval (CI) were pooled with a random-effects model to compare the risk of the primary outcome between the 2 procedures. The primary outcome was a composite of all-cause mortality or disabling/major stroke at 1 year. Seven studies with a total of 7,143 patients (3,665 TAVI) were included. All-cause mortality or disabling/major stroke at 30 days (6 studies, RR 0.71, 95% CI 0.49 to 1.03) was similar between TAVI and SAVR but was significantly lower in TAVI at 1 year (5 studies, RR 0.81, 95% CI 0.67 to 0.98). All-cause mortality was similar at both 30 days (7 studies, RR 0.90, 95% CI 0.67 to 1.21) and 1 year (6 studies, RR 0.89, 95% CI 0.76 to 1.04). Disabling/major stroke was similar between the 2 procedures (6 studies, RR 0.69, 95% CI 0.42 to 1.12) at 30 days but was significantly lower in TAVI at 1 year (5 studies RR 0.71, 95% CI 0.51 to 0.98). Age, gender, diabetes, and surgical risk score did not modulate the primary outcome. TAVI had a significantly lower composite of all-cause mortality or disabling/major stroke at 1 year compared with SAVR in low-to-intermediate surgical risk cohort., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to determine the prevalence of peripheral artery disease (PAD) and its association with in-hospital outcomes after endovascular transcatheter aortic valve replacement (EV-TAVR)., Background: TAVR is an established treatment for patients at prohibitive, high, or intermediate surgical risk. PAD is a significant comorbidity in the determination of surgical risk. However, data on association of PAD with outcomes after EV-TAVR are limited., Methods: Patients in the National Inpatient Sample who underwent EV-TAVR between January 1, 2012 and September 30, 2015 were evaluated. The primary outcome was in-hospital mortality., Results: A total of 51,685 patients underwent EV-TAVR during the study period. Of these, 12,740 (24.6%) had a coexisting diagnosis of PAD. The adjusted odds for in-hospital mortality [OR 1.08 (95% CI 0.83-1.41)], permanent pacemaker implantation [OR 0.98 (0.85-1.14)], conversion to open aortic valve replacement [OR 1.05 (0.49-2.26)], or acute myocardial infarction [OR 1.31(0.99-1.71)] were not different in patients with versus without PAD. However, patients with PAD had greater adjusted odds of vascular complications [OR 1.80 (1.50-2.16)], major bleeding [OR 1.20 (1.09-1.34)], acute kidney injury (AKI) [OR 1.19 (1.05-1.36)], cardiac complications [aOR 1.21 (1.01-1.44)], and stroke [OR 1.39(1.10-1.75)] compared with patients without PAD. Length of stay (LOS) was significantly longer for patients with PAD [7.23 (0.14) days vs. 7.11 (0.1) days, p < 0.001]., Conclusion: Of patients undergoing EV-TAVR, ~25% have coexisting PAD. PAD was not associated with increased risk of in-hospital mortality but was associated with higher risk of vascular complications, major bleeding, AKI, stroke, cardiac complications, and longer LOS., (© 2019 Wiley Periodicals, Inc.)

Transcatheter aortic valve implantation (TAVI) procedures have increased exponentially since FDA approval in 2011. Older patients who underwent aortic valve replacement, either TAVI or surgical aortic valve replacement (SAVR), have elevated risk. Using the National Readmission Database, we included patients ≥80 years who underwent either TAVI or SAVR from 2011 to 2015. In-hospital outcomes of TAVI versus SAVR were compared using propensity-matched analysis to reduce the confounding effect of between-group imbalances. We identified a total of 30,590 TAVI and 54,204 SAVR procedures performed during the study period. The propensity score-matching algorithm yielded 19,713 patients in each group. The in-hospital mortality rates were significantly lower in TAVI compared with SAVR (3.4% vs 6.8%, p <0.001). Similarly, the 30-day readmission rate (15.2% vs 18.1% p = 0.001), in-hospital complications, mean length of stay (7 vs 12 days, p <0.001), and hospital cost (US$ 60,534 vs US$ 67,426) were significantly lower for TAVI patients. There was a significant increase in the use of TAVI (26 cased per month in 2011 to 1,237/month in 2015) and a decrease in SAVR (1,409/month in 2011 to 859/month in 2015) during the study period. In-patient mortality significantly decreased for patients who underwent TAVI (4.4% in 2011 to 2.5% in 2015) and did not significantly change for patients who underwent SAVR (5.0% in 2011 to 4.7% in 2015). Overall, the number of SAVR procedures remained two thirds higher than TAVI. In conclusion, in octo- and nonagenarians, TAVI is an effective and safer alternative to SAVR as it is associated with lower in-hospital mortality, lower major in-hospital complications, lower 30-day readmission rate, and hospital costs. Despite this, SAVR remained the most common approach in octogenarians, although the trends in this data set, suggest a shift in practice patterns for this cohort., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: To assess the in-hospital outcomes of transcatheter aortic valve replacement (TAVR) vs. surgical aortic valve replacement (SAVR) in non-teaching hospitals., Background: TAVR has become widely available in the United States. However, the comparative outcomes of TAVR vs. SAVR in non-teaching hospitals are largely under explored., Methods: We queried the Nationwide Inpatient Sample database from 2011 to September 2015 to identify those who were 50 years or above and underwent either trans-arterial TAVR or SAVR at non-teaching hospital. In-hospital clinical outcomes were compared with odds ratio (OR) in propensity-matched cohorts., Results: We identified un-weighted 957 and 7,465 SAVR admissions. In propensity-matched model, 596 admissions in each arm were included for final analysis. In-patient mortality (3.9 vs. 2.5%, OR 1.54, P = 0.34), acute kidney injury requiring dialysis (2.2 vs. 2.7%, OR 0.80, P = 0.57), stroke (2.0 vs. 3.2%, OR 0.61, P = 0.20), and pacemaker placement (8.9 vs. 6.4%, OR 1.47, P = 0.09) was similar between TAVR and SAVR. Sub-group analysis showed that female and those with prior coronary artery bypass surgery had higher risk of in-patient morality in TAVR admission. Cost was higher (59,103 vs. 53,411 dollars, P = 0.006) but length of stay was shorter in TAVR (6.9 vs. 10.2 days, P < 0.001)., Conclusions: TAVR conferred similar in-hospital mortality and major peri-procedural complications compared with SAVR in non-teaching hospitals. For those with limited access to teaching hospitals, non-teaching hospitals appear to be a reasonable option for candidates of aortic valve replacement for severe aortic stenosis., (© 2018 Wiley Periodicals, Inc.)

Background: A significant proportion of patients requiring aortic valve replacement (AVR) have undergone prior coronary artery bypass grafting (CABG). Reoperative heart surgery is associated with increased risk. Data on relative utilization and comparative outcomes of transcatheter (TAVR) versus surgical AVR (SAVR) in patients with prior CABG are limited., Methods and Results: We queried the 2012 to 2014 National Inpatient Sample databases to identify isolated AVR hospitalizations in adults with prior CABG. In-hospital outcomes of TAVR versus SAVR were compared using propensity-matched analysis. Of 147 395 AVRs, 15 055 (10.2%) were in patients with prior CABG. The number of TAVRs in patients with prior CABG increased from 1615 in 2012 to 4400 in 2014, whereas the number of SAVRs decreased from 2285 to 1895 ( P trend <0.001). There were 3880 records in each group in the matched cohort. Compared with SAVR, TAVR was associated with similar in-hospital mortality (2.3% versus 2.4%; P =0.71) but lower incidence of myocardial infarction (1.5% versus 3.4%; P <0.001), stroke (1.4% versus 2.7%; P <0.001), bleeding complications (10.6% versus 24.6%; P <0.001), and acute kidney injury (16.2% versus 19.3%; P <0.001). Requirement for prior permanent pacemaker was higher in the TAVR cohort, whereas the incidence of vascular complications and acute kidney injury requiring dialysis was similar in the 2 groups. Average length of stay was shorter in patients undergoing TAVR., Conclusions: TAVR is being increasingly used as the preferred modality of AVR in patients with prior CABG. Compared with SAVR, TAVR is associated with similar in-hospital mortality but lower rates of in-hospital complications in this important subset of patients., (© 2018 American Heart Association, Inc.)

Background: Transcatheter aortic valve replacement (TAVR) is typically performed under general anesthesia (GA). However, there is increasing data supporting the safety of performing TAVR under local anesthesia/conscious sedation (LA). We performed a meta-analysis to gain better understanding of the safety and efficacy of LA versus GA in patients with severe aortic stenosis undergoing TAVR., Methods and Results: We comprehensively searched EMBASE, PubMed, and Web of Science. Effect sizes were summarized using risk ratios (RRs) difference of the mean (DM), and 95% CIs (confidence intervals) for dichotomous and continuous variables respectively. Twenty-six studies and 10,572 patients were included in the meta-analysis. The use of LA for TAVR was associated with lower overall 30-day mortality (RR, 0.73; 95% CI, 0.57-0.93; P = 0.01), use of inotropic/vasopressor drugs (RR, 0.45; 95% CI, 0.28-0.72; P < 0.001), hospital length of stay (LOS) (DM, -2.09; 95% CI, -3.02 to -1.16; P < 0.001), intensive care unit LOS (DM, -0.18; 95% CI, -0.31 to -0.04; P = 0.01), procedure time (DM, -25.02; 95% CI, -32.70 to -17.35; P < 0.001); and fluoroscopy time (DM, -1.63; 95% CI, -3.02 to -0.24; P = 0.02). No differences were observed between LA and GA for stroke, cardiovascular mortality, myocardial infarction, permanent pacemaker implantation, acute kidney injury, paravalvular leak, vascular complications, major bleeding, procedural success, conduction abnormalities, and annular rupture., Conclusion: Our meta-analysis suggests that use of LA for TAVR is associated with a lower 30-day mortality, shorter procedure time, fluoroscopy time, ICU LOS, hospital length of stay, and reduced need for inotropic support., (© 2017 Wiley Periodicals, Inc.)

Objectives: This study sought to determine the association of chronic kidney disease (CKD) with in-hospital outcomes of transcatheter aortic valve replacement (TAVR)., Background: CKD is a known independent risk factor for worse outcomes after surgical aortic valve replacement (SAVR). However, data on outcomes of patients with CKD undergoing TAVR are limited, especially in those on chronic dialysis., Methods: The authors used data from the 2012 to 2014 National Inpatient Sample database to identify all patients ≥18 years of age who underwent TAVR. International Classification of Diseases-Ninth Revision-Clinical Modification codes were used to identify patients with no CKD, CKD (without chronic dialysis), or end-stage renal disease (ESRD) on long-term dialysis. Multivariable logistic regression models were constructed using generalized estimating equations to examine in-hospital outcomes., Results: Of 41,025 patients undergoing TAVR from 2012 to 2014, 25,585 (62.4%) had no CKD, 13,750 (33.5%) had CKD, and 1,690 (4.1%) had ESRD. Compared with patients with no CKD, in-hospital mortality was significantly higher in patients with CKD or ESRD (3.8% vs. 4.5% vs. 8.3%; adjusted odds ratio [no CKD as reference]: 1.39 [95% confidence interval: 1.24 to 1.55] for CKD and 2.58 [95% confidence interval: 2.09 to 3.13] for ESRD). Patients with CKD or ESRD had a higher incidence of major adverse cardiovascular events (composite of death, myocardial infarction, or stroke), net adverse cardiovascular events (composite of major adverse cardiovascular events, major bleeding, or vascular complications), and pacemaker implantation compared with patients without CKD. Acute kidney injury (AKI) and AKI requiring dialysis were associated with several-fold higher risk-adjusted in-hospital mortality in patients in the no CKD and CKD groups. Moreover, the incidence of AKI and AKI requiring dialysis did not decline during the study period., Conclusions: Patients with CKD or ESRD have worse in-hospital outcomes after TAVR. AKI is associated with higher in-hospital mortality in patients undergoing TAVR and the incidence of AKI has not declined over the years., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to surgical aortic-valve replacement (SAVR) for patients with severe symptomatic aortic stenosis (AS) who are at high operative risk. We sought to determine the long-term (≥1year follow-up) safety and efficacy TAVR compared with SAVR in patients with severe AS., Methods: A comprehensive search of PubMed, EMBASE, Cochrane Central Register of Controlled Trials, conference proceedings, and relevant Web sites from inception through 10 April 2016., Results: Fifty studies enrolling 44,247 patients met the inclusion criteria. The mean duration follow-up was 21.4months. No difference was found in long-term all-cause mortality (risk ratios (RR), 1.06; 95% confidence interval (CI) 0.91-1.22). There was a significant difference favoring TAVR in the incidence of stroke (RR, 0.82; 95% CI 0.71-0.94), atrial fibrillation (RR, 0.43; 95% CI 0.33-0.54), acute kidney injury (RR, 0.70; 95% CI 0.53-0.92), and major bleeding (RR, 0.57; 95% CI 0.40-0.81). TAVR had significant higher incidence of vascular complications (RR, 2.90; 95% CI 1.87-4.49), aortic regurgitation (RR, 7.00; 95% CI 5.27-9.30), and pacemaker implantation (PPM) (RR, 2.02; 95% CI 1.51-2.68). TAVR demonstrated significantly lower stroke risk compared to SAVR in high-risk patients (RR, 1.49; 95% CI 1.06-2.10); no differences in PPM implantation were observed in intermediate-risk patients (RR, 1.68; 95% CI 0.94-3.00). In a meta-regression analysis, the effect of TAVR baseline clinical features did not affect the long-term all-cause mortality outcome., Conclusion: TAVR and SAVR showed similar long-term survival in patients with severe AS; with important differences in treatment-associated morbidity., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Bivalirudin may be an effective anticoagulation alternative to heparin as anticoagulant agent in percutaneous transcatheter aortic valve interventions (PAVI). We aimed to compare safety and efficacy of bivalirudin versus heparin as the procedural anticoagulant agent in patients undergoing PAVI.Methods: We conducted an electronic database search of all published data. The primary efficacy endpoints were all-cause mortality, cardiovascular mortality, myocardial infarction, and stroke. Safety endpoints include major and life-threatening bleed according to VARC and BARC bleeding, blood transfusion, vascular complications, and acute kidney injury. Odds ratios (OR) and 95% confidence intervals (CI) computed using the Mantel-Haenszel method.Results: Three studies (n = 1690 patients) were included, one randomized trial and two observational studies. There was a significant difference favoring bivalirudin over heparin for myocardial infarction (OR 0.41, 95%CI 0.20-0.87). There was no significant difference in all-cause mortality at 30 days (OR 0.97, 95%CI 0.62-1.52), cardiovascular mortality (OR 1.03, 95%CI 0.52-2.05), stroke (OR 1.23, 95%CI 0.62-2.46), vascular complications (OR 0.96, 95%CI 0.70-1.32), acute kidney injury (OR 1.03, 95%CI 0.53-2.00), blood transfusion (OR 0.67, 95% CI 0.45-1.01), major and life-threatening bleed (OR 0.74, 95%CI 0.37-1.49), and BARC bleeding (OR 0.52, 95%CI 0.23-1.18).Conclusions: In patient undergoing aortic valve interventions, no difference was seen between the use of bivalirudin and heparin as the procedural anticoagulant agent, except for a significant lower myocardial infarction events when bivalirudin was used. Further large randomized trials are needed to confirm current results. [ABSTRACT FROM AUTHOR]

Background: Detailed procedural analysis and long-term data is limited for coronary protection (CP) during transcatheter aortic valve replacement (TAVR) for patients with high anatomical risk for coronary occlusion (CO). We aim to assess the procedural and mid-term outcomes of CP during TAVR.Methods: We retrospectively analyzed patients who underwent TAVR at Henry Ford Hospital, USA from January 2015 to August 2019 and identified those considered at risk of CO and underwent pre-emptive CP with or without subsequent "chimney" stenting (i.e. coronary stenting with intentional protrusion into the aorta). Procedural features, immediate and mid-term clinical outcomes were reviewed.Results: Twenty-five out of 1166 (2.1%) patients underwent TAVR with CP, including 10 (40%) valve-in-valve procedures. Twenty-eight coronary arteries (Left: n = 11, Right: n = 11; Left + Right: n = 3) were protected. Eleven coronaries (39.3%) were electively "chimney"-stented due to angiographic evidence of coronary impingement (63.6%), tactile resistance while withdrawing stent (27.3%) and electrocardiogram change (9.1%). Twenty-four patients (24/25, 96%) had successful TAVR without CO. Procedure-related complications included stent-balloon entrapment (n = 1), stent entrapment (n = 1) and occlusive distal stent edge dissection (n = 1). After a mean follow-up of 19.1 months, there was 1 cardiac death but no target vessel re-intervention or myocardial infarction.Conclusions: Our study found that angiographic evidence of coronary impingement (63.6%) was the most common reason for stent deployment during TAVR with CP. The mid-term clinical outcome of CP with TAVR was favorable. [ABSTRACT FROM AUTHOR]

Whether readmission to non-index hospitals (where the initial procedure was not performed) could result in adverse outcomes and increased utilization of healthcare resources compared with readmission to index hospitals after transcatheter aortic valve replacement (TAVR) remains unclear. From January 2012 to September 2015, a nationwide readmission database was queried to identify those who were older than 50 years and had endovascular TAVR, using the International Classification of Disease, 9th Revision, Clinical Modification code 35.05. Elective readmissions were excluded. In-hospital outcomes were compared between the index and non-index hospital readmissions. A multivariable logistic regression analysis was performed to identify predictors of non-index hospital readmissions. A total of 6808 readmissions were identified of which 2564 (37.7%) were readmitted to non-index hospitals. Residents at smaller counties, metropolitan non-teaching hospitals, or hospitals at large metropolitan areas were predictors of non-index readmissions. In-hospital mortality (adjusted odds ratio [aOR] 1.27, p = 0.20), acute myocardial infarction (aOR 0.83, p = 0.53), pacemaker placement (aOR 0.97, p = 0.90), acute kidney injury (aOR 0.98, p = 0.84), and stroke (aOR 1.03, p = 0.90) were similar between index and non-index readmissions but bleeding events requiring transfusions were more frequently observed in readmissions at non-index hospitals (aOR 1.32, p = 0.025). Hospital cost (15,410 dollars vs. 16,390 dollars, p = 0.25) and length of stay (5.70 days vs. 5.65 days, p = 0.85) were comparable between groups. Non-index readmissions post-TAVR was relatively common but did not result in increased hospital mortality or healthcare utilization. Our results are reassuring for TAVR recipients with limited access to index hospitals. • Non-index hospital readmissions were common post-TAVR, at 37.7%. • Outcomes and cost were mostly similar between index versus non-index readmission. • These findings are reassuring for those with limited access to index hospitals. [ABSTRACT FROM AUTHOR]

Purpose: To identify racial/ethnic disparities in utilization rates, in-hospital outcomes and health care resource use among Non-Hispanic Whites (NHW), African Americans (AA) and Hispanics undergoing transcatheter aortic valve replacement (TAVR) in the United States (US).Methods and Results: The National Inpatient Sample database was queried for patients ≥18 years of age who underwent TAVR from 2012 to 2014. The primary outcome was all-cause in hospital mortality. A total of 36,270 individuals were included in the study. The number of TAVR performed per million population increased in all study groups over the three years [38.8 to 103.8 (NHW); 9.1 to 26.4 (AA) and 9.4 to 18.2 (Hispanics)]. The overall in-hospital mortality was 4.2% for the entire cohort. Race/ethnicity showed no association with in-hospital mortality (P > .05). Though no significant difference were found between AA and NHW in any secondary outcome, being Hispanic was associated with higher incidence of acute myocardial infarction (aOR = 2.02; 95% CI, 1.06-3.85; P = .03), stroke/transient ischemic attack (aOR = 1.81; 95% CI, 1.04-3.14; P = .04), acute kidney injury (aOR = 1.65; 95% CI, 1.23-2.21; P < .01), prolonged length of stay (aOR = 1.18; 95% CI, 1.08-1.29; P < .01) and higher hospital costs (aOR = 1.27; 95% CI, 1.18-1.36; P < .01).Conclusion: There are significant racial disparities in patients undergoing TAVR in the US. Though in-hospital mortality was not associated with race/ethnicity, Hispanic patients had less TAVR utilization, higher in-hospital complications, prolonged length of stay and increased hospital costs. [ABSTRACT FROM AUTHOR]

Background: Several studies have pair-wise compared access sites for transcatheter aortic valve replacement (TAVR) but pooled estimate of overall comparative efficacy and safety outcomes are not well known. We sought to compare short- and long-term outcomes following various alternative access routes for TAVR.Methods: Thirty-four studies with a pooled sample size of 32,756 patients were selected by searching PubMed and Cochrane library databases from inception through 11th June 2021 for patients undergoing TAVR via 1 of 6 different access sites: Transfemoral (TF), Transaortic (TAO), Transapical (TA), Transcarotid (TC), Transaxillary/Subclavian (TSA), and Transcaval (TCV). Data were extracted to conduct a frequentist network meta-analysis with a random-effects model using TF access as a reference group.Results: Compared with TF, both TAO [RR 1.91, 95% CI (1.46-2.50)] and TA access [RR 2.12, 95% CI (1.84-2.46)] were associated with an increased risk of 30-day mortality. No significant difference was observed for stroke, myocardial infarction, major bleeding, conversion to open surgery, and major adverse cardiovascular or cerebrovascular events at 30 days between different accesses. Major vascular complications were lower in TA [RR 0.43, (95% CI, 0.28-0.67)] and TC [RR 0.51, 95% CI (0.35-0.73)] access compared to TF. The 1-year mortality was higher in TAO [RR of 1.35, (95% CI, 1.01-1.81)] and TA [RR 1.44, (95% CI, 1.14-1.81)] groups.Conclusion: Non-thoracic alternative access site utilization for TAVR implantation (TC, TSA and TCV) is associated with outcomes similar to conventional TF access. Thoracic TAVR access (TAO and TA) translates into increased short and long-term mortality. [ABSTRACT FROM AUTHOR]

Background: Stroke after transcatheter aortic valve replacement (TAVR) occurs with an incidence of 4-11% and is a particularly devastating adverse event associated with the procedure. Several cerebral protection devices (CPD) have been developed to prevent cerebrovascular events during TAVR. While most studies have shown CPD to be associated with decreased number and volume of lesions on diffusion weighted magnetic resonance imaging, the clinical benefit of these devices remains uncertain.Methods: We aimed to use meta-analysis techniques to study the clinical safety and efficacy of these CPD in prospective randomized and non-randomized studies. Data was summarized as Mantel-Haenszel relative risk (RR) and 95% confidence intervals (CI). We used the Higgins' I2 statistic to evaluate heterogeneity.Results: We found no evidence of difference between patients with and without CPD [RR 0.70 (95% CI 0.40-1.21)] for the primary composite outcome of stroke and mortality at 30 days. The two groups were also comparable in peri-procedural strokes [RR 0.53 (95% CI 0.27-1.07)], stroke at 30 days [RR 0.69(95% CI 0.38-1.26)], mortality [RR 0.59 (95% CI 0.22-1.59) at 30 days, AKI [RR 0.68(95% CI 0.28-1.62)], major bleeding [RR 0.56 (95% CI 0.26-1.18)], life threating bleeding [0.54 (95% CI 0.19-1.53)] and major vascular complications [RR 0.80 (95% CI 0.52-1.24)]. The risk of strokes within the first week of TAVR was significantly lower in the CPD group [0.56(95% CI 0.33-0.96)].Conclusion: CPD are associated with a decreased incidence of strokes within 1 week of follow-up without showing any evidence of increased risk of other peri-procedural adverse events. [ABSTRACT FROM AUTHOR]