Transcatheter heart valve explant with infective endocarditis-associated prosthesis failure and outcomes: the EXPLANT-TAVR international registry.

BACKGROUND AND AIMS: Surgical explantation of transcatheter heart valves (THVs) is rapidly increasing, but there are limited data on patients with THV-associated infective endocarditis (IE). This study aims to assess the outcomes of patients undergoing THV explant for IE. METHODS: All patients who underwent THV explant between 2011 and 2022 from 44 sites in the EXPLANT-TAVR registry were identified. Patients with IE as the reason for THV explant were compared to those with other mechanisms of bioprosthetic valve dysfunction (BVD). RESULTS: A total of 372 patients from the EXPLANT-TAVR registry were included. Among them, 184 (49.5%) patients underwent THV explant due to IE and 188 (50.5%) patients due to BVD. At the index transcatheter aortic valve replacement, patients undergoing THV explant for IE were older (74.3 ± 8.6 vs. 71 ± 10.6 years) and had a lower Society of Thoracic Surgeons risk score [2.6% (1.8-5.0) vs. 3.3% (2.1-5.6), P = .029] compared to patients with BVD. Compared to BVD, IE patients had longer intensive care unit and hospital stays (P < .05) and higher stroke rates at 30 days (8.6% vs. 2.9%, P = .032) and 1 year (16.2% vs. 5.2%, P = .010). Adjusted in-hospital, 30-day, and 1-year mortality was 12.1%, 16.1%, and 33.8%, respectively, for the entire cohort, with no significant differences between groups. Although mortality was numerically higher in IE patients 3 years postsurgery (29.6% for BVD vs. 43.9% for IE), Kaplan-Meier analysis showed no significant differences between groups (P = .16). CONCLUSIONS: In the EXPLANT-TAVR registry, patients undergoing THV explant for IE had higher 30-day and 1-year stroke rates and longer intensive care unit and hospital stays. Moreover, patients undergoing THV explant for IE had a higher 3-year mortality rate, which did not reach statistical significance given the relatively small sample size of this unique cohort and the reduced number of events.

A Scoping Review of Definitions of Success in Endovascular Aortic Arch Repair.

INTRODUCTION: The present standard of care to treat aortic arch pathologies is open surgical repair with cardiopulmonary bypass and deep hypothermic arrest. With approaches for total endovascular and extra-anatomic cervical debranching hybrid arch repair becoming more diverse, understanding what is considered a successful operation is prerequisite for a rigorous comparison of techniques. This review describes the specific outcomes reported, the rates of success, and the definitions of technical and clinical success in total endovascular and extra-anatomic cervical debranching hybrid aortic arch repair. METHODS: A comprehensive search of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials was performed. Studies with patients undergoing total endovascular or hybrid extra-anatomic cervical debranching repair of the aortic arch were included. Any publications including only patients with Ishimaru zone 2 or distal repairs were excluded from this review. Studies with less than 5 patients were excluded. Data extraction was performed by one author. Data items included were study design, procedure type, procedural details, underlying pathology, type of cervical debranching, type of endograft repair, surgical outcomes, definition of cerebrovascular events, technical success, and the definition of technical success. RESULTS: Of 1754 studies screened for review, 85 studies with 5521 patients were included. By frequency, the included studies examined the following interventions: fenestrated devices, branched devices, parallel grafting. Most studies were retrospective single-institution studies. There were no randomized controlled trials. Short-term mortality and cerebrovascular events were nearly universally reported, present in 99% and 95% of studies reviewed, respectively. Only 27% of studies provided an explicit definition for cerebrovascular events. While 75% of studies reported a technical success rate, only 45% of those studies provided explicit criteria. Clinical success rates were infrequently reported, present in only 5.9% of studies reviewed. CONCLUSION: The definitions of technical success that were provided fell short of analogous defined reporting standards in nearly all studies, inflating technical success rates. Definitions of cerebrovascular events and technical success require stringent criteria to uniformly compare various methods of endovascular aortic arch repair. A societal consensus document for reporting standards of endovascular aortic arch repair would allow for higher-quality outcomes research. CLINICAL IMPACT: Total endovascular and extra-anatomic cervical debranching hybrid operations are being increasingly utilized for complex aortic arch repair. These techniques, however, can be associated with serious complications. Currently, there is no accepted metric to define technical or report clinical outcomes. Due to the paucity of high-quality data, use of these approaches may be limited in clinical practice. This study emphasizes the need for the development of standards for reporting outcomes in endovascular aortic arch repair. Future studies can then utilize these benchmarks, whcih will allow for improved efficacy and safety in these techniques.

Risk Factors for Stroke Development After Thoracic Aortic Surgery.

OBJECTIVES: Stroke after thoracic aortic surgery is a complication that is associated with poor outcomes. The aim is to characterize the intraoperative risk factors for stroke development. DESIGN: A retrospective analysis. SETTING: Tertiary, high-volume cardiac surgery center. PARTICIPANTS: Patients who had surgical repair of thoracic aortic diseases from January 1, 2017, through December 31, 2021. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 704 patients were included, of whom 533 had ascending aortic aneurysms, and 171 had type A aortic dissection. The incidence of postoperative stroke was 4.5% (95% CI 2.9%-6.6%) for ascending aortic aneurysms compared with 12.3% (95% CI 7.8%-18.16%) in type-A aortic dissections. Patients who developed postoperative strokes had significantly lower intraoperative hemoglobin median (7.5 gm/dL [IQR 6.8-8.6] v 8.55 gm/dL [IQR 7.3-10.0]; p < 0.001). The median cardiopulmonary bypass time was 185 minutes (IQR 136-328) in the stroke group versus 156 minutes (IQR 113-206) in the nonstroke group (p = 0.014). Circulatory arrest was used in 57.8% versus 38.5% of the nonstroke patients (p = 0.017). The initial temperature after leaving the operating room was lower, with a median of 35.0°C (IQR 34-35.92) in the stroke group versus 35.5°C (IQR 35-36) in the nonstroke cohort (p = 0.021). CONCLUSIONS: This single-center study highlighted the potential importance of intra-operative factors in preventing stroke. Lower hemoglobin, longer duration of cardiopulmonary bypass, deep hypothermic circulatory arrest, and postoperative hypothermia are potential risk factors for postoperative stroke. Further studies are needed to prevent this significant complication in patients with thoracic aortic diseases.

Impact of left ventricular outflow tract calcium on valve geometry in self-expanding transcatheter aortic-valve replacement.

OBJECTIVES: Evaluate transcatheter heart valve (THV) geometry according to left ventricular outflow tract (LVOT) calcium degree and its impact on hemodynamics and outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) with a contemporary self-expanding THV. BACKGROUND: LVOT calcium remains challenging for contemporary THVs. LVOT calcium location and degree may affect THV deployment and impact flow patterns and shear stress, accelerating THV degeneration. METHODS: EPROMPT (CoreValve Evolut Pro Prospective Registry; NCT03423459) is a prospective, investigator-initiated, multicenter registry of patients undergoing TAVR using CoreValve Evolut PRO/PRO + THVs. A total of 107 patients were enrolled in EPROMPT's computed tomography (CT) cohort between January 2018 and October 2021. These patients underwent follow-up CT scan 30 days post-TAVR. We analyzed THV geometry and its interaction with the aortic root following deployment using 30-day post-TAVR CT in patients with none/mild versus moderate/severe LVOT calcium. RESULTS: Thirty-day THV inflows were less eccentric in the short axis in patients with none/mild versus moderate/severe LVOT calcium (1.16 ± 0.09 vs. 1.21 ± 0.12; p = 0.007). THV became more circular and was similar between both cohorts at the THV waist (1.08 ± 0.06 vs. 1.09 ± 0.11; p = 0.551), leaflet tips (1.03 ± 0.04 vs. 1.05 ± 0.09; p = 0.299), and THV outflow (1.04 ± 2.2 vs. 1.03 ± 2.7; p = 0.143). Thirty-day > mild paravalvular leak was low in both cohorts (1.5% vs. 2.4%; p = 0.724); mean gradients were similar (7.7 ± 3.6 vs. 7.7 ± 3.4 mmHg; p = 0.955). CONCLUSIONS: Despite inflow deformities observed in patients with moderate/severe LVOT calcium, Evolut PRO/PRO + conforms to elliptical aortic annuli, maintaining circularity and proper function at the leaflets and outflow, even in patients with moderate/severe LVOT calcium.

Prosthetic valve endocarditis after transcatheter aortic valve replacement in low-risk patients.

OBJECTIVES: We sought to report details of the incidence, organisms, clinical course, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter aortic valve replacement (TAVR) in low-risk patients. BACKGROUND: PVE remains a rare but devastating complication of aortic valve replacement. Data regarding PVE after TAVR in low-risk patients are lacking. METHODS: We performed a detailed review of all patients in the low-risk TAVR trials who underwent TAVR from 2016 to 2020 and were adjudicated to have definitive PVE by the independent Clinical Events Committee. RESULTS: We analyzed 396 low-risk patients who underwent TAVR (including 72 with bicuspid valves). PVE occurred in 11 patients at a median 379 days (210, 528) from TAVR. The incidence within the first 30 days was 0%; days 31-365, 1.5%; and after day 365, 2.8%. The most common organism identified was Streptococcus (n = 4/11). Early PVE (≤ 365 days) occurred in five patients, of whom three demonstrated evidence of embolic stroke and two underwent surgical aortic valve re-intervention. Late PVE (> 365 days) occurred in six patients, of whom thee demonstrated evidence of embolic stroke and only one underwent surgical aortic valve re-intervention. Of the six patients with evidence of embolic stroke, two died, two were discharged to rehabilitation, and two were discharged home with home care. CONCLUSIONS: PVE was infrequent following TAVR in low-risk patients but was associated with substantial morbidity and mortality. Embolic stroke complicated the majority of PVE cases, contributing to worse outcomes in these patients. Efforts must be undertaken to minimize PVE in TAVR.

Transcatheter aortic valve replacement in low-risk patients: 2-year results from the LRT trial.

BACKGROUND: Previous studies from the Low Risk TAVR (LRT) trial demonstrated that transcatheter aortic valve replacement (TAVR) is safe and feasible in low-risk patients, with excellent 30-day and 1-year outcomes. The objective of this study was to report clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration (SVD) 2 years after TAVR. METHODS: The LRT trial was the first Food and Drug Administration-approved Investigational Device Exemption trial in the United States to evaluate the safety and feasibility of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis (AS). Valve hemodynamics and SVD by echo were recorded 30 days, 1 year, and 2 years post-TAVR. RESULTS: The LRT trial enrolled 200 low-risk patients to receive TAVR. Their mean age was 73.6 years and 61.5% were men. At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%. The disabling stroke rate was 1.1%, permanent pacemaker implantation rate was 8.6%, and 4 patients (2.2%) presented with endocarditis (2 between years 1 and 2). Of the 14% of TAVR subjects who had evidence of HALT at 30 days, there was no impact on valve hemodynamics, endocarditis or stroke at 2 years. CONCLUSIONS: TAVR for low-risk patients with symptomatic severe tricuspid AS is safe at 2 years. The presence of HALT at 30 days did not impact the early hemodynamic improvements nor the durability of the valve structure.

Parallel Grafting Should Be Considered as a Viable Alternative to Open Repair in High-Risk Patients With Paravisceral Aortic Aneurysms.

BACKGROUND: Parallel grafting presents a viable method for treating patients with complex aortic aneurysms. The current literature is limited to mostly pararenal configurations. We examined our results in patients with SMA and/or Celiac artery involvement. METHODS: A retrospective analysis was performed for all patients undergoing parallel grafting during the period of 2014 to 2018 at a single institution. All patients had at least SMA with and/or without Celiac artery parallel grafting. RESULTS: Seventy-nine patients (65% male, median age 74) were treated with 208 parallel grafts. Median ASA score is 4. Forty-nine cases were elective, 22 urgent, and 8 emergent. Mean pre-operative aneurysm diameter was 7.1 cm (4.6-15 cm). Self-expanding covered stents were used for the renal arteries (mean 6.3mm), and balloon-expandable covered stents were used for the SMA and Celiac (mean SMA 8.6 mm, mean celiac 8.3 mm). Axillary exposure was the choice of access in 68 patients (86%). Technical success was achieved in all cases. We defined this as aneurysm sac exclusion with patent visceral stent grafts, and absent to mild gutter leaks. Mean aortic graft proximal seal achieved was 48mm. Coverage extended above the celiac artery in 75% (10% stented and 65% covered). Median contrast volume was 145ml, operative duration was 4 hours, fluoroscopy time was 56 min, and EBL was 250 ml. Perioperative mortality was 6.1%. 4.5%, and 25%, for the elective, urgent, and emergent groups, respectively. There was no incidence of spinal cord ischemia. Axillary access was complicated in 4 patients, requiring patch closure of the axillary artery. One patient developed postprocedural ESRD from a rupture and ATN despite patent renal stents. Of those patients with a patent GDA and celiac coverage, 2 required a cholecystectomy. Nine patients had a persistent gutter leak at the conclusion of the procedure. Median follow-up was 12 months. On follow-up imaging, all SMA and Celiac stents were patent. Six renal stents were occluded and 2 patients progressed to ESRD, both solitary renal periscope configurations at the index procedure. Only 4 patients had persistent gutter leaks with 2 requiring reintervention. Ninety-five percent of patients demonstrated sac regression or stabilization with a mean sac size of 6.5 cm. CONCLUSIONS: Parallel grafting presents a safe, efficacious and off the shelf alternative to conventional repair of complex aortic aneurysms involving the visceral aorta.

Role of contractile reserve as a predictor of mortality in low-flow, low-gradient severe aortic stenosis following transcatheter aortic valve replacement.

OBJECTIVES: The aim of this study was to determine the prognostic value of contractile reserve (CR) at baseline in patients with low-flow, low-gradient severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Patients with severe AS, left ventricular dysfunction, and low transaortic gradient are at high risk for mortality during surgical aortic valve replacement (SAVR). Furthermore, patients without CR have been shown to have perioperative mortality comparable to that of patients treated medically for severe AS. METHODS: We retrospectively analyzed patients who underwent TAVR with a diagnosis of low-gradient severe AS (mean transvalvular aortic gradient < 40 mmHg, LVEF < 50%, and AVA ≤ 1.0 cm2 or AVAi ≤ 0.6 cm2 ) and who had a pre-TAVR dobutamine stress echocardiogram (DSE). Patients were stratified by the presence or absence of CR, defined as an increase in stroke volume ≥ 20% during DSE. RESULTS: From 2008 to 2016, 61 patients with low-gradient severe AS underwent TAVR and had pre-TAVR DSE. CR was present in 31 patients (51%) and absent in 30 (49%). There was no significant difference between the two groups in baseline demographics, medical history, access site, or types of valves. All-cause mortality was similar in both groups at 30 days (13% with CR vs 10% without CR, P = 1.00) and 1 year (29% with CR vs 33% without CR, HR 1.20, 95% CI 0.49-2.96, P = 0.69). CONCLUSION: In patients with low-flow, low-gradient severe AS undergoing TAVR, the presence or absence of CR does not predict all-cause mortality at 30 days or 1 year.

Utility of an additive frailty tests index score for mortality risk assessment following transcatheter aortic valve replacement.

BACKGROUND: The impact of frailty assessment on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) remains unclear. Our aim was to evaluate the individual effect of each frailty test and the utility of an additive frailty index score on short- and long-term survival following TAVR. METHODS: Retrospective analysis of consecutive TAVR patients for whom a complete set of frailty tests was obtained: algorithm defined grip strength and 5-m walking tests, body mass index <20 kg/m2, Katz activities of daily living ≤4/6, serum albumin <3.5 g/dL. Frailty status was defined as having 3 or more positive frailty tests. Included were 498 patients with a mean age of 82±8 years. RESULTS: Frailty status, observed in 266 (53%) patients, was associated with both 30-day and 1-year mortality (6% vs. 2%, P=.016; 20% vs. 9%, P<.001; within the respective frailty groups). As compared to 0-2 frailty criteria, a higher frailty index score was associated with increased risk of death at 1 year (OR 2.23; 95% CI 1.14-4.34; P=.019 and OR 3.30; 95% CI 1.36-8.00; P=.008 for 3 and 4-5 frailty criteria met, respectively). In Cox regression analysis, frailty status was correlated with 1-year mortality (HR=2.2; 95%CI 1.25-3.96; P=.007), and a higher frailty index was associated with increased mortality risk (HR=2.0; 95% CI 1.08-3.7; P=.027; and HR=3.07; 95% CI 1.4-6.7; P=.005; for any 3, and 4-5 frailty criteria, respectively). CONCLUSIONS: Frailty status and a higher frailty index score were associated with increased 1-year mortality risk following TAVR.

Predicted magnitude of alternate access in the contemporary transcatheter aortic valve replacement era.

OBJECTIVES: We aimed to evaluate the true extent of alternate access in a contemporary cohort of transcatheter aortic valve replacement (TAVR) patients. BACKGROUND: Appropriate access selection for TAVR impacts clinical outcomes. Despite device miniaturization, some patients remain ineligible for transfemoral arterial access. METHODS: Five hundred seventy-five consecutive TAVR patients were classified according to iliofemoral artery diameters measured by computed tomography (<5.0 mm, 5.0-5.4 mm, 5.5-5.9 mm, or ≥6 mm) and need for alternate access rate was estimated according to commercially available transcatheter heart valve Instructions For Use (IFU). RESULTS: Based on iliofemoral artery diameters alone, 11.5% of patients were predicted to require alternate access. After patient-level adjustment for the size of the planned THV and severe tortuosity or severe calcification, 14.9% and 20.8% of patients, respectively were predicted to require alternate access. Overall, 87.8% of patients underwent transfemoral TAVR and 12.3% underwent alternate access. There was no difference in the rate of major vascular complications and life threatening or major bleeding between groups, but transfusion rate was higher in smaller vessel groups. CONCLUSIONS: Despite device miniaturization, a substantial minority of contemporary TAVR patients still require alternate access. Most are eligible for newer extrathoracic approaches including transcaval, subclavian, and transcarotid that avoid the morbidity of transthoracic access.

The impact of cusp overlap on permanent pacemaker requirement following self-expanding transcatheter aortic valve replacement.

BACKGROUND/PURPOSE: The cusp overlap technique has standardized implantation for self-expanding valves with the goal of achieving more consistent implantation depths and lowering permanent pacemaker (PPM) implantation rates. We retrospectively compared short-term outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) with a self-expanding valve implanted using the cusp overlap technique vs. the traditional coplanar technique in a large tertiary referral center. METHODS: We conducted a retrospective study among PPM-naïve patients who underwent TAVR using the CoreValve Evolut PRO/PRO+. We compared in-hospital PPM rates in patients who underwent TAVR using the cusp overlap technique vs. the coplanar technique. Additional outcomes included in-hospital all-cause mortality, stroke, major vascular complications, annular rupture, and >mild paravalvular leak. Furthermore, we compared outcomes over time to see whether there was evidence of a learning curve. RESULTS: Of the 528 patients included, 270 underwent TAVR using the coplanar technique and 258 underwent TAVR using the cusp overlap technique. The rate of new PPM implantation did not differ between cohorts (17.0 % vs. 16.7 %; p = 0.910). Additionally, rates of in-hospital all-cause mortality (0.0 % vs. 0.4 %; p = 0.328), stroke (3.7 % vs. 1.6 %; p = 0.124), major vascular complications (0.7 % vs. 1.2 %; p = 0.617), annular rupture (0.4 % vs. 0.0 %; p = 0.328) and >mild paravalvular leak (0.0 % vs. 0.4 %; p = 0.444) were similar. Our secondary analysis did not identify any evidence of a learning curve. CONCLUSIONS: The cusp overlap technique may not yield a reduction in PPM rates when compared with the coplanar technique. Other confounders should be explored to further minimize in-hospital PPM rates.

One-Year Results of a Low-Profile Endograft in Acute, Complicated Type B Aortic Dissection.

BACKGROUND: The safety and effectiveness of the RelayPro endograft (Terumo Aortic) was assessed for the treatment of acute, complicated type B aortic dissection (TBAD). METHODS: A prospective pivotal trial analyzed a primary end point of all-cause mortality at 30 days. Secondary end points included technical success, major adverse events (disabling stroke, renal failure, and paraplegia/paralysis), endoleaks, patency, rupture, device integrity, false lumen perfusion, reinterventions, aortic expansion, and migration evaluated to 5 years. RESULTS: The study involved 22 United States centers and enrolled 56 patients (mean age, 59.5 ± 11.4 years) from 2017 to 2021; of whom, 73.2% were men and 53.6% were African American. TBAD was complicated by malperfusion of the kidneys (51.8%), lower extremities (35.7%), and viscera (33.9%), and rupture (10.7%). Dissection extended proximally to zones 1/2 (14.3%) and zone 3 (78.6%) and distally to the iliac arteries (67.3%). Most procedures were percutaneous (85.5%). Technical success was 100%. Median hospitalization was 7 days (interquartile range, 5-12 days). All-cause mortality at 30 days was 1.8% (1 of 56; upper 95% CI, 8.2%; P < .0001). Seven major adverse events occurred in 6 patients (10.7%), consisting of paraplegia (n = 3), paraparesis (n = 2), disabling stroke (n = 1), and renal failure (n = 1). All paraplegia/paraparesis resolved with lumbar drainage. Kaplan-Meier analysis estimated a freedom from major adverse events of 89.1% at each interval from 30 days to 3 years. There was 1 endoleak (Type Ia), 2 retrograde dissections, and aortic diameter growth occurred in 2. There has been no rupture, fistula, component separation, patency loss, stenosis, kinking, twisting, bird beak, loss of device integrity, or fracture. CONCLUSIONS: RelayPro is safe and effective in acute, complicated TBAD. Follow-up is ongoing to evaluate longer-term outcomes and durability.

Self-expanding and balloon-expandable valves in low risk TAVR patients.

BACKGROUND: Recent randomized studies have broadened the indication of transcatheter aortic valve replacement (TAVR) to also include low-surgical-risk patients. However, the data on self-expanding (SE) and balloon-expandable (BE) valves in low-risk patients remain sparse. METHODS: The current study is a post hoc analysis of combined data from both LRT 1.0 and 2.0 trials comparing BE and SE transcatheter heart valves. RESULTS: A total of 294 patients received a BE valve, and 102 patients received an SE valve. The 30-day clinical outcomes were similar across both groups except for stroke (4.9% vs. 0.7%, p = 0.014) and permanent pacemaker implantation (17.8% vs. 5.8%, p < 0.001), which were higher in the SE cohort than the BE cohort. No difference was observed in terms of paravalvular leak (≥moderate) between the groups (0% vs. 1.5%, p = 0.577). SE patients had higher aortic valve area (1.92 ± 0.43 mm2 vs. 1.69 ± 0.45 mm2, p < 0.001) and lower mean gradient (8.93 ± 3.53 mmHg vs. 13.41 ± 4.73 mmHg, p < 0.001) than BE patients. In addition, the rate of subclinical leaflet thrombosis was significantly lower in SE patients (5.6% vs. 13.8%, p = 0.038). CONCLUSION: In this non-randomized study assessing SE and BE valves in low-risk TAVR patients, SE valves are associated with better hemodynamics and lesser leaflet thrombosis, with increased rates of stroke and permanent pacemaker implantation at 30 days; however, this could be due to certain patient-dependent factors not fully evaluated in this study. The long-term implications of these outcomes on structural valve durability remain to be further investigated. CLINICAL TRIAL REGISTRY: LRT 1.0: NCT02628899 LRT 2.0: NCT03557242.

Effects of RBT-1 on preconditioning response biomarkers in patients undergoing coronary artery bypass graft or heart valve surgery: a multicentre, double-blind, randomised, placebo-controlled phase 2 trial.

Background: RBT-1 is a combination drug of stannic protoporfin (SnPP) and iron sucrose (FeS) that elicits a preconditioning response through activation of antioxidant, anti-inflammatory, and iron-scavenging pathways, as measured by heme oxygenase-1 (HO-1), interleukin-10 (IL-10), and ferritin, respectively. Our primary aim was to determine whether RBT-1 administered before surgery would safely and effectively elicit a preconditioning response in patients undergoing cardiac surgery. Methods: This phase 2, double-blind, randomised, placebo-controlled, parallel-group, adaptive trial, conducted in 19 centres across the USA, Canada, and Australia, enrolled patients scheduled to undergo non-emergent coronary artery bypass graft (CABG) and/or heart valve surgery with cardiopulmonary bypass. Patients were randomised (1:1:1) to receive either a single intravenous infusion of high-dose RBT-1 (90 mg SnPP/240 mg FeS), low-dose RBT-1 (45 mg SnPP/240 mg FeS), or placebo within 24-48 h before surgery. The primary outcome was a preoperative preconditioning response, measured by a composite of plasma HO-1, IL-10, and ferritin. Safety was assessed by adverse events and laboratory parameters. Prespecified adaptive criteria permitted early stopping and enrichment. This trial is registered with ClinicalTrials.gov, NCT04564833. Findings: Between Aug 4, 2021, and Nov 9, 2022, of 135 patients who were enrolled and randomly allocated to a study group (46 high-dose, 45 low-dose, 44 placebo), 132 (98%) were included in the primary analysis (46 high-dose, 42 low-dose, 44 placebo). At interim, the trial proceeded to full enrollment without enrichment. RBT-1 led to a greater preconditioning response than did placebo at high-dose (geometric least squares mean [GLSM] ratio, 3.58; 95% CI, 2.91-4.41; p < 0.0001) and low-dose (GLSM ratio, 2.62; 95% CI, 2.11-3.24; p < 0.0001). RBT-1 was generally well tolerated by patients. The primary drug-related adverse event was dose-dependent photosensitivity, observed in 12 (26%) of 46 patients treated with high-dose RBT-1 and in six (13%) of 45 patients treated with low-dose RBT-1 (safety population). Interpretation: RBT-1 demonstrated a statistically significant cytoprotective preconditioning response and a manageable safety profile. Further research is needed. A phase 3 trial is planned. Funding: Renibus Therapeutics, Inc.

Atrial fibrillation symptom reduction and improved quality of life following the hybrid convergent procedure: a CONVERGE trial subanalysis.

Background: CONVERGE was a prospective, multicenter, randomized controlled trial that evaluated the safety of Hybrid Atrial Fibrillation Convergent (HC) and compared its effectiveness to endocardial catheter ablation (CA) for the treatment of persistent atrial fibrillation (PersAF) and longstanding PersAF (LSPAF). In 2020, we reported that CONVERGE met its primary safety and effectiveness endpoints. The primary objective of the present study is to report CONVERGE trial results for quality of life (QOL) and Class I/III anti-arrhythmic drug (AAD) utilization following HC. Methods: Eligible patients had drug-refractory symptomatic PersAF or LSPAF and a left atrium diameter ≤6.0 cm. Enrolled patients were randomized 2:1 to receive HC or CA. Atrial Fibrillation Severity Scale (AFSS) and the 36-Item Short Form Health Survey (SF-36) were assessed at baseline and 12 months; statistical comparison was performed using paired t-tests. AAD utilization at baseline through 12 and 18 months post-procedure was evaluated; statistical comparison was performed using McNemar's tests. Results: A total of 153 patients were treated with either HC (n=102) or CA (n=51). Of the 102 HC patients, 38 had LSPAF. AFSS and SF-36 Mental and Physical Component scores were significantly improved at 12 months versus baseline with HC overall and for the subset of LSPAF patients treated with either HC or CA. The proportion of HC patients (n=102) who used Class I /III AADs at 12 and 18 months was significantly less (33.3% and 36.3%, respectively) than baseline (84.3%; P<0.001). In LSPAF patients who underwent HC (n=38), AADs use was 29.0% through 18 months follow-up versus 71.1% at baseline (P<0.001). Conclusions: HC reduced AF symptoms, significantly improved QOL, and reduced AAD use in patients with PersAF and LSPAF. ClinicalTrialsgov Identifier: NCT01984346.

Outcomes of del Nido cardioplegia after surgical aortic valve replacement and coronary artery bypass grafting.

OBJECTIVE: The use of del Nido cardioplegia (DNC) was initially adopted in the field of pediatric cardiac surgery. Several studies in adult patients suggested there were no differences in early postoperative outcomes as compared to blood-based cardioplegia. We sought to evaluate the impact of DNC as compared to modified Buckberg cardioplegia (BC) on early postoperative outcomes in patients undergoing surgical aortic valve replacement with and without coronary artery bypass grafting (SAVR ± CABG). METHODS: All SAVR ± CABG procedures were switched from BC to DNC at our institute in 2012. We compared outcomes of BC (November 2007-October 2012; n = 1037) with DNC (November 2012-December 2017; n = 1067). Significant baseline differences were observed between the two groups and such differences were adjusted via inverse propensity treatment weighting. RESULTS: After adjustment, SAVR ± CABG patients who received DNC required longer aortic cross-clamp times, while postoperative peak troponin I and creatinine kinase-MB isotype were significantly lower in the BC group. Length of hospital and intensive care unit stay were significantly shorter in the DNC group. The incidence of postoperative complications was lower in the DNC cohort. Thirty-day mortality rate was significantly lower in the DNC group (3.0% vs 4.9%, p = 0.002). CONCLUSIONS: The use of DNC cardioplegia in our cohort of adult patients who underwent SAVR ± CABG was safe and associated with improved postoperative outcomes. However, the use of DNC may be associated with higher degrees of myocardial injury.

Post-Myocardial Infarction Free-Wall Rupture: Rapid Diagnosis and Management.

We present a case of post-myocardial infarction free-wall rupture in a critically ill patient presenting to the emergency department. Through our case we highlight the prompt evaluation, diagnosis, and management necessary to improve survival in a patient with this life-threatening condition. (Level of Difficulty: Beginner.).

TAVR in 2023: Who Should Not Get It?

Since the first transcatheter delivery of an aortic valve prosthesis was performed by Cribier et al in 2002, the picture of aortic stenosis (AS) therapeutics has changed dramatically. Initiated from an indication of inoperable to high surgical risk, extending to intermediate and low risk, transcatheter aortic valve replacement (TAVR) is now an approved treatment for patients with severe, symptomatic AS across all the risk categories. The current evidence supports TAVR as a frontline therapy for treating severe AS. The crucial question remains concerning the subset of patients who still are not ideal candidates for TAVR because of certain inherent anatomic, nonmodifiable, and procedure-specific factors. Therefore, in this study, we focus on these scenarios and reasons for referring selected patients for surgical aortic valve replacement in 2023.

Clinical Profile and Outcomes of Patients With Pure Aortic Regurgitation Who Underwent Surgical Aortic Valve Replacement.

Surgical aortic valve replacement (SAVR) remains the standard of care for patients with chronic severe aortic regurgitation (AR). The introduction of a dedicated transcatheter heart valve for AR has fueled interest in using transcatheter aortic valve replacement to treat patients with isolated AR. We aimed to characterize the profile and outcomes of patients with symptomatic severe AR who underwent isolated SAVR. We conducted a retrospective, observational study of patients who underwent isolated SAVR for symptomatic severe AR at our institution. The primary outcome was in-hospital all-cause mortality. Patients were followed up with 30-day clinical and echocardiographic assessment. A total of 979 patients who underwent SAVR for severe AR between January 2015 and June 2021 were screened for eligibility, of whom 112 patients (11.4%) underwent isolated SAVR for symptomatic severe AR and were included in this analysis. Approximately 25% of patients were deemed to be at intermediate or high risk (n = 26 of 112). The primary outcome occurred in 2.7% of patients (n = 3 of 112). In-hospital stroke occurred in 2.7% of patients (n = 3 of 112), and new-onset atrial fibrillation occurred in 32.1% (n = 36 of 112). At 30-day follow-up, all-cause mortality occurred in 3.6% of patients (n = 4 of 112), and 0.8% (1 of 112) had >mild AR. In conclusion, in a tertiary referral center, the number of patients who underwent isolated SAVR for pure AR represented a small fraction of the overall SAVR patients. The vast majority were low risk and younger when compared with patients with severe aortic stenosis. SAVR yielded excellent short-term mortality and echocardiographic improvements.

Subclinical leaflet thrombosis and antithrombotic therapy post-TAVI: An LRT substudy.

BACKGROUND: Subclinical leaflet thrombosis (SLT) is characterized on computed tomography (CT) imaging as hypoattenuated leaflet thickening (HALT), reduced leaflet motion (RELM), and hypoattenuation affecting motion (HAM). How antithrombotic regimen type impacts SLT remains poorly understood. We evaluated how antithrombotic regimen type impacts SLT in low-risk subjects following transcatheter aortic valve implantation (TAVI). METHODS: This substudy is a post hoc analysis of the LRT 1.0 and 2.0 trials to assess SLT in subjects who underwent CT or transoesophageal echocardiogram (TOE) imaging at 30 days, stratified by antithrombotic regimen received (single antiplatelet therapy [SAPT], dual antiplatelet therapy [DAPT], or oral anticoagulation). We also utilized univariable logistic regression modelling to identify echocardiographic predictors of HALT. RESULTS: Rates of HALT, RELM, and HAM were all significantly lower with oral anticoagulation compared to SAPT or DAPT at 30 days (HALT: 2.6% vs 14.3% vs 17.2%, respectively, with p < 0.001; RELM: 1.8% vs 9.6% vs 13.1%, respectively, with p = 0.004; and HAM: 0.9% vs 8.5% vs 9.8%, respectively, with p = 0.011). Additionally, short-term oral anticoagulation was not associated with higher bleeding rates compared to SAPT or DAPT (0.8% vs. 1.8% vs. 3.6%, p = 0.291). The presence of HALT did not significantly impact echocardiographic haemodynamic parameters at 30 days. CONCLUSION: This is the largest study to date that evaluated the impact of different antithrombotic regimens on SLT in low-risk TAVI patients. Oral anticoagulation was associated with significantly lower rates of SLT at 30 days compared to DAPT or SAPT, and there was no apparent benefit of DAPT over SAPT.