New Universal Strain Software Accurately Assesses Cardiac Systolic and Diastolic Function Using Speckle Tracking Echocardiography

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/108658/1/echo12512.pd

Atrioventricular conduction in patients undergoing pacemaker implant following self‐expandable transcatheter aortic valve replacement

BackgroundHeart block requiring a pacemaker is common after self‐expandable transcatheter aortic valve replacement (SE‐TAVR); however, conduction abnormalities may improve over time. Optimal device management in these patients is unknown.ObjectiveTo evaluate the long‐term, natural history of conduction disturbances in patients undergoing pacemaker implantation following SE‐TAVR.MethodsAll patients who underwent new cardiac implantable electronic device (CIED) implantation at Michigan Medicine following SE‐TAVR placement between January 1, 2012 and September 25, 2017 were identified. Electrocardiogram and device interrogation data were examined during follow‐up to identify patients with recovery of conduction. Logistic regression analysis was used to compare clinical and procedural variables to predict conduction recovery.ResultsFollowing SE‐TAVR, 17.5% of patients underwent device placement for new atrioventricular (AV) block. Among 40 patients with an average follow‐up time of 17.1 ± 8.1 months, 20 (50%) patients had durable recovery of AV conduction. Among 20 patients without long‐term recovery, four (20%) had transient recovery. The time to transient conduction recovery was 2.2 ± 0.2 months with repeat loss of conduction at 8.2 ± 0.9 months. On multivariate analysis, larger aortic annular size (odds ratio: 0.53 [0.28–0.86]/mm, P = 0.02) predicted lack of conduction recovery.ConclusionsHalf of the patients undergoing CIED placement for heart block following SE‐TAVR recovered AV conduction within several months and maintained this over an extended follow‐up period. Some patients demonstrated transient recovery of conduction before recurrence of conduction loss. Larger aortic annulus diameter was negatively associated with conduction recovery.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/150495/1/pace13694_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/150495/2/pace13694.pd

Surgical Explantation of Transcatheter Aortic Valve Bioprostheses: A Statewide Experience

BACKGROUND: Despite the rapid adoption of transcatheter aortic valve replacement (TAVR) since its initial approval in 2011, the frequency and outcomes of surgical explantation of TAVR devices (TAVR-explant) is poorly understood. METHODS: Patients undergoing TAVR-explant between January 2012 and June 2020 at 33 hospitals in Michigan were identified in the Society of Thoracic Surgeons Database and linked to index TAVR data from the Transcatheter Valve Therapy Registry through a statewide quality collaborative. The primary outcome was operative mortality. Indications for TAVR-explant, contraindications to redo TAVR, operative data, and outcomes were collected from Society of Thoracic Surgeons and Transcatheter Valve Therapy databases. Baseline Society of Thoracic Surgeons Predicted Risk of Mortality was compared between index TAVR and TAVR-explant. RESULTS: Twenty-four surgeons at 12 hospitals performed TAVR-explants in 46 patients (median age, 73). The frequency of TAVR-explant was 0.4%, and the number of explants increased annually. Median time to TAVR-explant was 139 days and among known device types explanted, most were self-expanding valves (29/41, 71%). Common indications for TAVR-explant were procedure-related failure (35%), paravalvular leak (28%), and need for other cardiac surgery (26%). Contraindications to redo TAVR included need for other cardiac surgery (28%), unsuitable noncoronary anatomy (13%), coronary obstruction (11%), and endocarditis (11%). Overall, 65% (30/46) of patients underwent concomitant procedures, including aortic repair/replacement in 33% (n=15), mitral surgery in 22% (n=10), and coronary artery bypass grafting in 16% (n=7). The median Society of Thoracic Surgeons Predicted Risk of Mortality was 4.2% at index TAVR and 9.3% at TAVR-explant (P=0.001). Operative mortality was 20% (9/46) and 76% (35/46) of patients had in-hospital complications. Of patients alive at discharge, 37% (17/37) were discharged home and overall 3-month survival was 73±14%. CONCLUSIONS: TAVR-explant is rare but increasing, and its clinical impact is substantial. As the utilization of TAVR expands into younger and lower-risk patients, providers should consider the potential for future TAVR-explant during selection of an initial valve strategy

Clinical impact of baseline chronic kidney disease in patients undergoing transcatheter or surgical aortic valve replacement

ObjectivesTo assess the treatment effect of TAVR versus SAVR on clinical outcomes to 3 years in patients stratified by chronic kidney disease (CKD) by retrospectively studying patients randomized to TAVR or SAVR.BackgroundThe impact of CKD on mid‐term outcomes of patients undergoing TAVR versus SAVR is unclear.MethodsPatients randomized to TAVR or SAVR in the CoreValve US Pivotal High Risk Trial were retrospectively stratified by eGFR: none/mild or moderate/severe CKD. To evaluate the impact of baseline CKD in TAVR patients only, all patients undergoing an attempted TAVR implant in the US Pivotal Trial and CAS were stratified by baseline eGFR into none/mild, moderate, and severe CKD. The primary endpoint was major adverse cardiovascular and renal events (MACRE), a composite of all‐cause mortality, myocardial infarction, stroke/TIA, and new requirement of dialysis.ResultsModerate/severe CKD was present in 62.7% and 60.7% of high‐risk patients randomized to TAVR or SAVR, respectively. Baseline characteristics were similar between TAVR and SAVR patients in both CKD subgroups, except for higher rates of diabetes and higher serum creatinine in SAVR patients. Among high‐risk patients with moderate/severe CKD, TAVR provided a lower 3‐year MACRE rate compared with SAVR: 42.1% vs. 51.0, P = .04. Of 3,733 extreme‐ and high‐risk TAVR patients, 39.9% had none/mild, 53.8% moderate, and 6.4% severe CKD. Worsening baseline CKD was associated with increased 3‐year MACRE rates [none/mild 51.5%, moderate 54.5%, severe 63.1%, P = .001].ConclusionsTAVR results in lower 3‐year MACRE versus SAVR in high‐risk patients with moderate/severe CKD. In patients undergoing TAVR, worsening CKD increases mid‐term mortality and MACRE. Randomized trials of TAVR vs. SAVR in patients with moderate‐severe CKD would help elucidate the best treatment for these complex patients.Trial RegistrationCoreValve US Pivotal Trial: NCT01240902.CoreValve Continued Access Study: NCT01531374.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/148361/1/ccd27928_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/148361/2/ccd27928.pd

The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart interventions

ObjectivesThis multicenter retrospective study of the initial U.S. experience evaluated the safety and efficacy of temporary cardiac pacing with the Tempo® Temporary Pacing Lead.BackgroundDespite increasing use of temporary cardiac pacing with the rapid growth of structural heart procedures, temporary pacing leads have not significantly improved. The Tempo lead is a new temporary pacing lead with a soft tip intended to minimize the risk of perforation and a novel active fixation mechanism designed to enhance lead stability.MethodsData from 269 consecutive structural heart procedures were collected. Outcomes included device safety (absence of clinically significant cardiac perforation, new pericardial effusion, or sustained ventricular arrhythmia) and efficacy (clinically acceptable pacing thresholds with successful pace capture throughout the index procedure). Postprocedure practices and sustained lead performance were also analyzed.ResultsThe Tempo lead was successfully positioned in the right ventricle and achieved pacing in 264 of 269 patients (98.1%). Two patients (0.8%) experienced loss of pace capture. Procedural mean pace capture threshold (PCT) was 0.7 ± 0.8 mA. There were no clinically significant perforations, pericardial effusions, or sustained device‐related arrhythmias. The Tempo lead was left in place postprocedure in 189 patients (71.6%) for mean duration of 43.3 ± 0.7 hr (range 2.5–221.3 hr) with final PCT of 0.84 ± 1.04 mA (n = 80). Of these patients, 84.1% mobilized out of bed with no lead dislodgment.ConclusionThe Tempo lead is safe and effective for temporary cardiac pacing for structural heart procedures, provides stable peri and postprocedural pacing and allows mobilization of patients who require temporary pacing leads.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/154941/1/ccd28476.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/154941/2/ccd28476_am.pd

Safety and efficacy of thrombectomy in patients undergoing primary percutaneous coronary intervention for Acute ST elevation MI: A Meta-Analysis of Randomized Controlled Trials

Clinical trials comparing thrombectomy devices with conventional percutaneous coronary interventions (PCI) in patients with acute ST elevation myocardial infarction (STEMI) have produced conflicting results. The objective of our study was to systematically evaluate currently available data comparing thrombectomy followed by PCI with conventional PCI alone in patients with acute STEMI