Percutaneous ventricular assist device for higher-risk percutaneous coronary intervention in surgically ineligible patients: Indications and outcomes from the OPTIMUM study.

BACKGROUND: Indications and outcomes for percutaneous ventricular assist device (pVAD) use in surgically ineligible patients undergoing percutaneous coronary intervention (PCI) remain poorly characterized. AIMS: We sought to describe the use and timing of pVAD and outcome in surgically ineligible patients. METHODS: Among 726 patients enrolled in the prospective OPTIMUM study, clinical and health status outcomes were assessed in patients who underwent pVAD-assisted PCI and those without pVAD. RESULTS: Compared with patients not receiving pVAD (N = 579), those treated with pVAD (N = 142) more likely had heart failure, lower left ventricular ejection fraction (30.7 ± 13.6 vs. 45.9 ± 15.5, p < 0.01), and higher STS 30-day predicted mortality (4.2 [2.1-8.0] vs. 3.3 [1.7-6.6], p = 0.01) and SYNTAX scores (36.1 ± 12.2, vs. 31.5 ± 12.1, p < 0.01). While the pVAD group had higher in-hospital (5.6% vs. 2.2%, p = 0.046), 30-day (9.0% vs. 4.0%, p = 0.01) and 6-month (20.4% vs. 11.7%, p < 0.01) mortality compared to patients without pVAD, this difference appeared to be largely driven by significantly higher mortality among the 20 (14%) patients with unplanned pVAD use (30% in-hospital mortality with unplanned PVAD vs. 1.6% with planned, p < 0.01; 30-day mortality, 38.1% vs. 4.5%, p < 0.01). The degree of 6-month health status improvement among survivors was similar between groups. CONCLUSION: Surgically ineligible patients with pVAD-assisted PCI had more complex baseline characteristics compared with those without pVAD. Higher mortality in the pVAD group appeared to be driven by very poor outcomes by patients with unplanned, rescue pVAD.

Outcomes of transcatheter aortic valve replacement for patients with severe aortic stenosis and concomitant aortic insufficiency: Insights from the TVT Registry.

AIMS: Data regarding outcomes for patients with severe aortic stenosis (AS) with concomitant aortic insufficiency (AI), undergoing transcatheter aortic valve replacement (TAVR) are limited. This study aimed to analyze the prevalence of severe AS with concomitant AI among patients undergoing TAVR and outcomes of TAVR in this patient group. METHODS AND RESULTS: Using data from the STS/ACC-TVT Registry, we identified patients with severe AS with or without concomitant AI who underwent TAVR between 2011 and 2016. Patients were categorized based on the severity of pre-procedural AI. Multivariable proportional hazards regression models were used to examine all-cause mortality and heart failure (HF) hospitalization at 1-year. Among 54,535 patients undergoing TAVR, 42,568 (78.1%) had severe AS with concomitant AI. Device success was lower in patients with severe AS with concomitant AI as compared with isolated AS. The presence of baseline AI was associated with lower 1 year mortality (HR 0.94 per 1 grade increase in AI severity; 95% CI, 0.91-0.98, P < .001) and HF hospitalization (HR 0.87 per 1 grade increase in AI severity; 95% CI, 0.84-0.91, P < .001). CONCLUSIONS: Severe AS with concomitant AI is common among patients undergoing TAVR, and is associated with lower 1 year mortality and HF hospitalization. Future studies are warranted to better understand the mechanisms underlying this benefit. SHORT ABSTRACT: In this nationally representative analysis from the United States, 78.1% of patients undergoing TAVR had severe AS with concomitant AI. Device success was lower in patients with severe AS with concomitant AI as compared with isolated AS. The presence of baseline AI was associated with lower 1 year mortality (HR 0.94 per 1 grade increase in AI severity; 95% CI, 0.91-0.98, P < .001) and HF hospitalization (HR 0.87 per 1 grade increase in AI severity; 95% CI, 0.84-0.91, P < .001).

Performance of the TRUE dilatation balloon valvuloplasty catheter beyond rated burst pressure: A bench study.

OBJECTIVES: We undertook an independent bench test assessing the performance of the TRUE dilatation (TD) balloon valvuloplasty catheter (Bard Vascular Inc., Tempe, AZ) beyond its rated burst pressure (RBP). BACKGROUND: The TD balloon has a RBP of six atmospheres (atm), and its performance beyond this RBP is poorly understood. Techniques such as bioprosthetic valve fracture require inflation pressures beyond manufacturer recommendations. METHODS: A 20, 22, 24, 26, and 28 mm TD balloon were inflated to increasing pressures in increments of 3 atm until balloon failure. Measurements were performed at the proximal, middle, and distal balloon segments with scientific digital calipers. Z-MED balloons (Braun Interventional Systems Inc., Bethlehem, PA) were used as a comparator. RESULTS: The mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon at nominal pressure (3 atm) was 20.02 ± 0.09, 21.77 ± 0.07, 23.9 ± 0.06, 25.82 ± 0.08, and 27.62 ± 0.08 mm, respectively. The maximal mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon was 20.39 ± 0.03 mm (15 atm), 22.35 ± 0.03 mm (15 atm), 24.55 ± 0.02 mm (15 atm), 26.48 ± 0.02 mm (12 atm), and 28.39 ± 0.03 mm (12 atm), respectively. The 20/22/24 and 26/28 mm balloon failed when inflated beyond 15 atm and 12 atm, respectively. Failure was due to either leakage or longitudinal balloon rupture. TD balloons were more likely to maintain dimensions similar to their labeled size and less likely to fail at higher pressures as compared to Z-MED balloons. CONCLUSION: The TD balloon catheter maintains a similar diameter to its labeled size, when inflated beyond its RBP. When inflated beyond 12 atm, the TD balloon can fail due to either leakage or rupture. This has implications for percutaneous structural heart interventions.

The Effect of Regional Anesthesia on Outcomes After Minimally Invasive Ivor Lewis Esophagectomy.

OBJECTIVE: The objective of the present study was to determine whether regional anesthesia in addition to general anesthesia was associated with improved outcomes compared with general anesthesia alone in minimally invasive Ivor Lewis esophagectomy. DESIGN: Retrospective cohort study. DESIGN: This study examined patients across multiple hospital institutions using the American College of Surgeons National Surgical Quality Improvement Program dataset. PARTICIPANTS: Patients who underwent minimally invasive Ivor Lewis esophagectomy were identified and grouped according to general plus regional anesthesia versus general anesthesia alone. MEASUREMENTS AND MAIN RESULTS: Using multivariate logistic regression, outcomes, including 30-day mortality, respiratory complications, infection, blood clots, reintubation, return to the operating room, and length of hospital stay, were examined. Of the 463 patients who underwent minimally invasive Ivor Lewis esophagectomy, 398 met study inclusion criteria. General and regional anesthesia were administered to 108 patients in the study, with the remainder receiving only general anesthesia. Multivariate regression demonstrated no difference in the primary outcome of 30-day mortality (0.93% for regional and general anesthesia, 2.07% for general anesthesia alone [odds ratio 0.49; p = 0.534]). There was no significant difference for any secondary outcome including return to the operating room, failure to wean from the ventilator, reintubation, surgical site infection, pneumonia, renal insufficiency and failure, cardiac arrest, acute myocardial infarction, transfusion, venous thromboembolism, urinary tract infection, length of hospital stay, or total number of complications per patient. CONCLUSIONS: Despite potential benefits of regional anesthesia for minimally invasive Ivor Lewis esophagectomy, the present study did not show significant differences in any outcomes between regional and general anesthesia versus general anesthesia alone.

Is Bioprosthetic Valve Fracture Beneficial for Patients with Larger Surgical Valves Undergoing Valve in Valve TAVR?

PURPOSE OF REVIEW: This review aims to summarize data regarding bioprosthetic valve fracture (BVF), a novel technique that involves fracturing the surgical valve sewing ring to allow for further expansion of the transcatheter heart valve in patients undergoing valve in valve transcatheter aortic valve replacement (VIV TAVR). RECENT FINDINGS: Bench testing and clinical experience have demonstrated that most, but not all, bioprosthetic surgical valves can be fractured. BVF in patients with small- and intermediate-sized surgical valves results in a lower residual valve gradient and larger final valve effective orifice area as compared with standard VIV TAVR. However, whether patients with larger bioprothetic valves benefit from BVF, and whether the hemodynamic benefits of BVF translate into improved clinical outcomes, is unknown. BVF improves the hemodynamic results of VIV TAVR in small surgical valves. However, further research is needed to determine whether BVF is beneficial for patients with larger surgical valves, and whether the hemodynamic benefits of BVF result in improved clinical outcomes.

The nature of shape constancy mechanisms as revealed by shape priming.

Five shape priming experiments are reported in which the target was either a five- or six-sided line-drawn figure and participants made a speeded two-alternative forced-choice judgment about the target's number of sides. On priming trials, the target was preceded by a briefly presented smaller line figure (the prime) and performance on these trials was gauged relative to a no-prime condition. In the first two experiments, primes were rendered invisible by the presentation of a backwards visual noise mask, respectively for a short (∼40 ms) or long duration (∼93 ms). No reliable priming effects arose under masked conditions. When these experiments were repeated without the mask, participants were speeded when the prime and target were related by a rigid through-the-plane rotation but not when the prime was a nonrigid, stretched version of the target. The same pattern of priming effects arose when, in a final experiment, novel irregular shapes were used. Collectively, the data reveal the operation of shape constancy mechanisms that are particularly sensitive to shape rigidity. The findings suggest that the visual system attempts to secure a correspondence between the rapid and successive presentations of the prime and the target by matching shapes according to a rigidity constraint.

Transesophageal echocardiographic diagnosis of a WATCHMAN left atrial appendage closure device thrombus 10 years following implantation.

Left atrial appendage closure with the WATCHMAN device is an alternative to chronic oral anticoagulation for thromboembolic prophylaxis in atrial fibrillation patients. Left atrial device-related thrombus (DRT) has been described in the first year after implant with an incidence of ~6%. A 79-year-old man underwent WATCHMAN device placement in 2006. Routine protocol specified follow-up transesophageal echocardiograms (TEE) at 6 weeks, 6 months, and 1 year following implant showed no evidence for DRT or peri-device flow. A decade after device implant, the patient presented with severe symptomatic aortic stenosis and underwent repeat TEE, which revealed a 21 mm × 18 mm DRT on the LA aspect of the WATCHMAN device. He was prescribed apixaban 5 mg po BID. A TEE performed 111 days later demonstrated marked diminution in the DRT (9 mm in diameter). This case demonstrates that WATCHMAN DRT may occur late following implantation.

The Munroe-Meyer Approach: Continuous Integration of Didactic Instruction, Research, and Clinical Practice.

Increased demand for applied behavior analysis (ABA) services has increased the need for additional masters-level practitioners and doctoral-level academicians and clinical directors. Based on these needs, the University of Nebraska Medical Center's (UNMC) Munroe-Meyer Institute has developed a PhD program. The academic structure at UNMC allowed us to create our PhD program in a relatively quick and efficient manner. Our PhD program has many unique features, including (a) close integration of didactic instruction with clinical and research training provided by leading experts in ABA in which students immediately apply concepts introduced in the classroom during coordinated clinical and research practica; (b) structured grant writing training in which students learn to write and submit an NIH-level grant;

Critical aortic stenosis and acute ascending aortic penetrating ulcer managed utilizing transapical TAVR and TEVAR.

Thoracic endovascular aortic repair (TEVAR) of acute ascending aortic pathology is feasible; however, the unique features of this aortic segment in addition to access challenges restricts its use to a select, high-risk subset of patients. With the advent of TAVR, large device delivery using transapical access has become a well-defined technique. We report a patient with critical aortic stenosis and an acute ascending aortic penetrating ulcer with tamponade managed successfully utilizing transapical TAVR and TEVAR. To our knowledge, this is the first reported case of a hybrid single-stage TAVR and ascending aortic TEVAR using transapical access.

Do not bite the hand that feeds you.

Radial artery pseudoaneurysms occur infrequently and are most commonly associated with medical interventions such as arterial lines or cardiac catheterization procedures. Animal bites, particularly cat bites, as a cause for radial artery pseudoaneurysms are extremely rare with only 1 previously reported case in the literature. A unique case of digital micro emboli from a radial artery pseudoaneurysm caused by a cat bite to the wrist is presented.

Endoscopic harvesting device type and outcomes in patients undergoing coronary artery bypass surgery.

OBJECTIVE: To evaluate angiographic and clinical outcomes associated with open and closed dissection tunnel endoscopic vein harvesting (EVH) devices. BACKGROUND: A previous PREVENT-IV (PRoject of Ex-vivo Vein graft ENgineering via Transfection IV) analysis reported that EVH for coronary artery bypass graft surgery was associated with worse outcomes than with traditional vein harvesting; however, outcomes by EVH device type were not available. METHODS: Using data from the PREVENT-IV trial, we compared 1549 patients from 75 surgical sites who underwent EVH with open (n = 390) or closed (n = 1159) harvest tunnel devices. Outcomes included the incidence of vein graft failure at 12 to 18 months and a composite of death, myocardial infarction, and revascularization through 5 years. RESULTS: Among patients undergoing open and closed tunnel EVH, no difference in the per-patient incidence of vein graft failure (43.8% vs 47.1%; adjusted odds ratio, 0.91; 95% confidence interval, 0.53-1.55; P = 0.724) or per-graft incidence of vein graft failure (25.5% vs 25.9%; adjusted odds ratio, 0.96; 95% confidence interval, 0.59-1.55; P = 0.847) was observed. At 5 years, no difference was observed in the primary composite clinical outcome between patients who underwent open and closed system EVH (21.5% vs 23.9%; adjusted hazard ratio, 0.85; 95% confidence interval, 0.66-1.10; P = 0.221). CONCLUSIONS: No differences in angiographic or clinical outcomes were observed among patients who underwent open versus closed tunnel endoscopic harvesting for coronary bypass surgery. These findings suggest that the risks associated with EVH that were reported in a previous PREVENT-IV analysis are not related to a specific EVH device.

Flavones induce neutrophil apoptosis by down-regulation of Mcl-1 via a proteasomal-dependent pathway.

Neutrophil apoptosis and subsequent nonphlogistic clearance by surrounding phagocytes are key to the successful resolution of neutrophilic inflammation, with dysregulated apoptosis reported in multiple human inflammatory diseases. Enhancing neutrophil apoptosis has proresolution and anti-inflammatory effects in preclinical models of inflammation. Here we investigate the ability of the flavones apigenin, luteolin, and wogonin to induce neutrophil apoptosis in vitro and resolve neutrophilic inflammation in vivo. Human neutrophil apoptosis was assessed morphologically and by flow cytometry following incubation with apigenin, luteolin, and wogonin. All three flavones induced time- and concentration-dependent neutrophil apoptosis (apigenin, EC=12.2 µM; luteolin, EC=14.6 µM; and wogonin, EC=28.9 µM). Induction of apoptosis was caspase dependent, as it was blocked by the broad-spectrum caspase inhibitor Q-VD-OPh and was associated with both caspase-3 and caspase-9 activation. Flavone-induced apoptosis was preceded by down-regulation of the prosurvival protein Mcl-1, with proteasomal inhibition preventing flavone-induced Mcl-1 down-regulation and apoptosis. The flavones abrogated the survival effects of mediators that prolong neutrophil life span, including lipoteichoic acid, peptidoglycan, dexamethasone, and granulocyte-macrophage colony stimulating factor, by driving apoptosis. Furthermore, wogonin enhanced resolution of established neutrophilic inflammation in a zebrafish model of sterile tissue injury. Wogonin-induced resolution was dependent on apoptosis in vivo as it was blocked by caspase inhibition. Our data show that the flavones induce neutrophil apoptosis and have potential as neutrophil apoptosis-inducing anti-inflammatory, proresolution agents.

A community outbreak of Salmonella enterica serotype Typhimurium associated with an asymptomatic food handler in two local restaurants.

Between January and April 2012, the city of Long Beach Department of Health and Human Services investigated an outbreak involving 19 case patients who had tested positive for Salmonella enterica serotype Typhimurium with indistinguishable pulsed-field gel electrophoresis patterns. All cases were residents of or traveled to the city of Long Beach, California, during their incubation period, and the majority of patients reported eating at one of two restaurants in Long Beach. This article describes the outbreak investigation that traced the source to an asymptomatic food handler working at both restaurants and highlights the importance of maintaining a high index of suspicion for food handlers when faced with local outbreaks of diarrheal illness.

Permanent Pacemaker Implantation and Long-Term Outcomes of Patients Undergoing Concomitant Mitral and Tricuspid Valve Surgery.

BACKGROUND: Tricuspid valve annuloplasty (TA) during mitral valve repair (MVr) is associated with increased risk of permanent pacemaker (PPM) implantation, but the magnitude of risk and long-term clinical consequences have not been firmly established. OBJECTIVES: This study assesses the incidence rates of PPM implantation after isolated MVr and following MVr with TA as well as the associated long-term clinical consequences of PPM implantation. METHODS: State-mandated hospital discharge databases of New York and California were queried for patients undergoing MVr (isolated or with concomitant TA) between 2004 and 2019. Patients were stratified by whether or not they received a PPM within 90 days of index surgery. After weighting by propensity score, survival, heart failure hospitalizations (HFHs), endocarditis, stroke, and reoperation were compared between patients with or without PPM. RESULTS: A total of 32,736 patients underwent isolated MVr (n = 28,003) or MVr + TA (n = 4,733). Annual MVr + TA volumes increased throughout the study period (P < 0.001, trend), and PPM rates decreased (P < 0.001, trend). The incidence of PPM implantation <90 days after surgery was 7.7% for MVr and 14.0% for MVr + TA. In 90-day conditional landmark-weighted analyses, PPMs were associated with reduced long-term survival among MVr (HR: 1.96; 95% CI: 1.75-2.19; P < 0.001) and MVr + TA recipients (HR: 1.65; 95% CI: 1.28-2.14; P < 0.001). In both surgical groups, PPMs were also associated with an increased risk of HFH (HR: 1.56; 95% CI: 1.27-1.90; P < 0.001) and endocarditis (HR: 1.95; 95% CI: 1.52-2.51; P < 0.001), but not with stroke or reoperation. CONCLUSIONS: Compared to isolated MVr, adding TA to MVr was associated with a higher risk of 90-day PPM implantation. In both surgical groups, PPM implantation was associated with an increase in mortality, HFH, and endocarditis.

Relationship between vein graft failure and subsequent clinical outcomes after coronary artery bypass surgery.

BACKGROUND: Vein graft failure (VGF) is common after coronary artery bypass graft surgery, but its relationship with long-term clinical outcomes is unknown. In this retrospective analysis, we examined the relationship between VGF, assessed by coronary angiography 12 to 18 months after coronary artery bypass graft surgery, and subsequent clinical outcomes. METHODS AND RESULTS: Using the Project of Ex Vivo Vein Graft Engineering via Transfection IV (PREVENT IV) trial database, we studied data from 1829 patients who underwent coronary artery bypass graft surgery and had an angiogram performed up to 18 months after surgery. The main outcome measure was death, myocardial infarction, and repeat revascularization through 4 years after angiography. VGF occurred in 787 of 1829 patients (43%). Clinical follow-up was completed in 97% of patients with angiographic follow-up. The composite of death, myocardial infarction, or revascularization occurred more frequently among patients who had any VGF compared with those who had none (adjusted hazard ratio, 1.58; 95% confidence interval, 1.21-2.06; P=0.008). This was due mainly to more frequent revascularization with no differences in death (adjusted hazard ratio, 1.04; 95% confidence interval, 0.71-1.52; P=0.85) or death or myocardial infarction (adjusted hazard ratio, 1.08; 95% confidence interval, 0.77-1.53; P=0.65). CONCLUSIONS: VGF is common after coronary artery bypass graft surgery and is associated with repeat revascularization but not with death and/or myocardial infarction. Further investigations are needed to evaluate therapies and strategies for decreasing VGF to improve outcomes in patients undergoing coronary artery bypass graft surgery.

Effect of an investigational vaccine for preventing Staphylococcus aureus infections after cardiothoracic surgery: a randomized trial.

IMPORTANCE: Infections due to Staphylococcus aureus are serious complications of cardiothoracic surgery. A novel vaccine candidate (V710) containing the highly conserved S. aureus iron surface determinant B is immunogenic and generally well tolerated in volunteers. OBJECTIVE: To evaluate the efficacy and safety of preoperative vaccination in preventing serious postoperative S. aureus infection in patients undergoing cardiothoracic surgery. DESIGN, SETTING, AND PARTICIPANTS: Double-blind, randomized, event-driven trial conducted between December 2007 and August 2011 among 8031 patients aged 18 years or older who were scheduled for full median sternotomy within 14 to 60 days of vaccination at 165 sites in 26 countries. INTERVENTION: Participants were randomly assigned to receive a single 0.5-mL intramuscular injection of either V710 vaccine, 60 µg (n = 4015), or placebo (n = 4016). MAIN OUTCOME MEASURES: The primary efficacy end point was prevention of S. aureus bacteremia and/or deep sternal wound infection (including mediastinitis) through postoperative day 90. Secondary end points included all S. aureus surgical site and invasive infections through postoperative day 90. Three interim analyses with futility assessments were planned. RESULTS: The independent data monitoring committee recommended termination of the study after the second interim analysis because of safety concerns and low efficacy. At the end of the study, the V710 vaccine was not significantly more efficacious than placebo in preventing either the primary end points (22/3528 V710 vaccine recipients [2.6 per 100 person-years] vs 27/3517 placebo recipients [3.2 per 100 person-years]; relative risk, 0.81; 95% CI, 0.44-1.48; P = .58) or secondary end points despite eliciting robust antibody responses. Compared with placebo, the V710 vaccine was associated with more adverse experiences during the first 14 days after vaccination (1219/3958 vaccine recipients [30.8%; 95% CI, 29.4%-32.3%] and 866/3967 placebo recipients [21.8%; 95% CI, 20.6%-23.1%], including 797 [20.1%; 95% CI, 18.9%-21.4%] and 378 [9.5%; 95% CI, 8.6%-10.5%] with injection site reactions and 66 [1.7%; 95% CI, 1.3%-2.1%] and 51 [1.3%; 95% CI, 1.0%-1.7%] with serious adverse events, respectively) and a significantly higher rate of multiorgan failure during the entire study (31 vs 17 events; 0.9 [95% CI, 0.6-1.2] vs 0.5 [95% CI, 0.3-0.8] events per 100 person-years; P = .04). Although the overall incidence of vaccine-related serious adverse events (1 in each group) and the all-cause mortality rate (201/3958 vs 177/3967; 5.7 [95% CI, 4.9-6.5] vs 5.0 [95% CI, 4.3-5.7] deaths per 100 person-years; P = .20) were not statistically different between groups, the mortality rate in patients with staphylococcal infections was significantly higher among V710 vaccine than placebo recipients (15/73 vs 4/96; 23.0 [95% CI, 12.9-37.9] vs 4.2 [95% CI, 1.2-10.8] per 100 person-years; difference, 18.8 [95% CI, 8.0-34.1] per 100 person-years). CONCLUSIONS AND RELEVANCE: Among patients undergoing cardiothoracic surgery with median sternotomy, the use of a vaccine against S. aureus compared with placebo did not reduce the rate of serious postoperative S. aureus infections and was associated with increased mortality among patients who developed S. aureus infections. These findings do not support the use of the V710 vaccine for patients undergoing surgical interventions. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00518687.

Transcarotid versus transaxillary access for transcatheter aortic valve replacement with a self-expanding valve: A propensity-matched analysis.

Transaxillary access has been the most frequently used nonfemoral access route for transcatheter aortic valve replacement (TAVR) with a self-expanding valve. Use of transcarotid TAVR is increasing; however, comparative data on these methods are limited. We compared outcomes following transcarotid or transaxillary TAVR with a self-expanding, supra-annular valve. Methods: The Transcatheter Valve Therapy Registry was queried for TAVR procedures using transaxillary and transcarotid access between July 2015 and June 2021. Patients received a self-expanding Evolut R, PRO, or PRO + valve (Medtronic) and had 1-year follow-up. Thirty-day and 1-year outcomes were compared in transcarotid and transaxillary groups after 1:2 propensity score-matching. Multivariable regression models were fitted to identify predictors of key end points. Results: The propensity score-matched cohort included 576 patients receiving transcarotid and 1142 receiving transaxillary access. Median procedure time (99 vs 118 minutes; P < .001) and hospital stay (2 vs 3 days; P < .001) were shorter with transcarotid versus transaxillary access. At 30 days, patients with transcarotid access had similar mortality (Kaplan-Meier estimates 3.7% vs 4.3%, P = .57) but significantly lower stroke (3.1% vs 5.9%; P = .017) and mortality or stroke (6.0% vs 8.9%; P = .033) compared with patients receiving transaxillary access. Similar differences were observed at 1 year. Transaxillary access was associated with increased risk of 30-day stroke (hazard ratio, 2.14; 95% confidence interval, 1.27-3.58) by multivariable regression analysis. Conclusions: Transcarotid versus transaxillary access for TAVR using a self-expanding valve is associated with procedural benefits and significantly lower stroke and mortality or stroke at 30 days. In patients with unsuitable femoral anatomy, transcarotid access may be the preferred delivery route for self-expanding valves.

Conformational changes during in vitro balloon fracture of internal aortic annuloplasty ring.

Objective: HAART 300 300 (BioStable Science and Engineering, Inc) aortic annuloplasty rings restore physiologic annular geometry during aortic valve repair. Transcatheter valve-in-ring implantation is appealing for recurrent valve dysfunction but may necessitate balloon fracture of downsized annuloplasty rings. We characterized the feasibility of ring fracture and changes in ring geometry preceding fracture. Methods: The 19-mm, 21-mm, and 23-mm HAART 300 annuloplasty rings were obtained, and 23-mm, 24-mm, 25-mm, and 26-mm valvuloplasty balloons were obtained. Under continuous fluoroscopy and video recording, a 23-mm balloon was inflated within a 19-mm ring at 1 atm/s until ring fracture or balloon failure occurred. If balloon failure occurred, experiments were sequentially repeated with 1-mm upsized balloons until ring fracture occurred or no larger-sized balloons were available. Results: Upon balloon inflation, all rings exhibited an irreversible conformational change from an elliptical, annular geometry to a circular shape with ring posts flaring outward. A 23-mm balloon burst at 21 atm without fracturing the 19-mm ring. The 24-mm balloon fractured the 19-mm ring at 15 atm. Likewise, a 24-mm balloon ruptured at 18 atm without fracturing the 21-mm annuloplasty ring. A 25-mm balloon fractured the 21-mm ring at 18 atm. Finally, a 26-mm balloon burst at 20 atm without fracturing a 23-mm annuloplasty ring, but it did elicit the confirmational changes described. All fractures occurred along the upslope of a ring post. The exposed metal frame was visible after the 21-mm ring fracture. Conclusions: Fracture of HAART 300 aortic annuloplasty rings is possible with an oversized, high-pressure balloon. However, the geometrical changes in the ring and subsequent rupture of its fabric covering may be obstacles to safe, in vivo ring fracture.

Outcomes of Bioprosthetic Valve Fracture in Patients Undergoing Valve-in-Valve TAVR.

BACKGROUND: Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) is increasingly used to treat degenerated surgical bioprostheses. Bioprosthetic valve fracture (BVF) has been shown to improve hemodynamic status in VIV TAVR in case series. However, the safety and efficacy of BVF are unknown. OBJECTIVES: The primary objective of this study was to assess the safety and efficacy of VIV TAVR using SAPIEN 3 and SAPIEN 3 Ultra valves with or without BVF using data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. METHODS: The primary outcome was in-hospital mortality. Secondary outcomes included echocardiography-derived valve gradient and aortic valve area. Inverse probability of treatment weighting was used to adjust for baseline characteristics. RESULTS: A total of 2,975 patients underwent VIV TAVR from December 15, 2020, to March 31, 2022. BVF was attempted in 619 patients (21%). In adjusted analyses, attempted BVF was associated with higher in-hospital mortality (OR: 2.51; 95% CI: 1.30-4.84) and life-threatening bleeding (OR: 2.55; 95% CI: 1.44-4.50). At discharge, VIV TAVR with attempted BVF was associated with larger aortic valve area (1.6 cm2 vs 1.4 cm2; P < 0.01) and lower mean gradient (16.3 mm Hg vs 19.2 mm Hg; P < 0.01). When BVF was compared with no BVF according to timing (before vs after transcatheter heart valve implantation), BVF after transcatheter heart valve implantation was associated with improved hemodynamic status and similar mortality. CONCLUSIONS: BVF as an adjunct to VIV TAVR with the SAPIEN 3 and SAPIEN 3 Ultra valves is associated with a higher risk for in-hospital mortality and significant bleeding and modest improvements in echocardiography-derived hemodynamic status. The timing of BVF is an important determinant of safety and efficacy.

Site Variability in Cerebral Embolic Protection for Transcatheter Aortic Valve Implantation and Association With Outcomes.

Background: The effectiveness of cerebral embolic protection devices (CEPD) in mitigating stroke after transcatheter aortic valve implantation (TAVI) remains uncertain, and therefore CEPD may be utilized differently across US hospitals. This study aims to characterize the hospital-level pattern of CEPD use during TAVI in the US and its association with outcomes. Methods: Patients treated with nontransapical TAVI in the 2019 Nationwide Readmissions Database were included. Hospitals were categorized as CEPD non-users and CEPD users. The following outcomes were compared: the composite of in-hospital stroke or transient ischemic attack (TIA), in-hospital ischemic stroke, death, and cost of hospitalization. Logistic regression models were used for risk adjustment of clinical outcomes. Results: Of 41,822 TAVI encounters, CEPD was used in 10.6% (n = 4422). Out of 392 hospitals, 65.8% were CEPD non-user hospitals and 34.2% were CEPD users. No difference was observed between CEPD non-users and CEPD users in the risk of in-hospital stroke or TIA (adjusted odds ratio (OR) = 0.99 [0.86-1.15]), ischemic stroke (adjusted OR = 1.00 [0.85-1.18]), or in-hospital death (adjusted OR = 0.86 [0.71-1.03]). The cost of hospitalization was lower in CEPD non-users. Conclusions: Two-thirds of hospitals in the US do not use CEPD for TAVI, and no significant difference was observed in neurologic outcomes among patients treated at CEPD non-user and CEPD user hospitals.