Transcatheter Left Ventricular Restoration in Patients With Heart Failure.

BACKGROUND: Left ventricular (LV) volume reshaping reduces myocardial wall stress and may induce reverse remodeling in patients with heart failure with reduced ejection fraction. The AccuCinch Transcatheter Left Ventricular Restoration system consists of a series of anchors connected by a cable implanted along the LV base that is cinched to the basal free wall radius. We evaluated the echocardiographic and clinical outcomes following transcatheter left ventricular restoration. METHODS AND RESULTS: We analyzed 51 heart failure patients with a left ventricular ejection fraction between 20% and 40%, with no more than 2+ mitral regurgitation treated with optimal medical therapy, who subsequently underwent transcatheter left ventricular restoration. Serial echocardiograms, Kansas City Cardiomyopathy Questionnaire scores, and 6-minute walk test distances were measured at baseline through 12 months. Primary analysis end point was change in end-diastolic volume at 12 months compared with baseline. Patients (n = 51) were predominantly male (86%) with a mean age of 56.3 ± 13.1 years. Fluoroscopy showed LV free wall radius decreased by a median of 9.2 mm amounting to a 29.6% decrease in the free wall arc length. At 12 months, the LV end-diastolic volume decreased by 33.6 ± 34.8 mL (P < .01), with comparable decreases in the LV end-systolic volume. These decreases were associated with significant improvements in the overall Kansas City Cardiomyopathy Questionnaire score (16.4 ± 18.7 points; P < .01) and 6-minute hall walk test distance (45.9 ± 83.9 m; P < .01). There were no periprocedural deaths; through the 1-year follow-up, 1 patient died (day 280) and 1 patient received a left ventricular assist device (day 13). CONCLUSIONS: In patients with heart failure with reduced ejection fraction without significant mitral regurgitation receiving optimal medical therapy, the AccuCinch System resulted in decreases of LV volume, as well as improved quality of life and exercise endurance. A randomized trial is ongoing (NCT04331769).

Association of Radial Artery Access with Reduced Incidence of Acute Kidney Injury.

Objectives: To determine if radial artery (RA) access compared with femoral artery (FA) access for percutaneous coronary intervention (PCI) is associated with a lower incidence of acute kidney injury (AKI). Background: AKI results in substantial morbidity and cost following PCI. Prior studies comparing the occurrence of AKI associated with radial artery (RA) versus femoral artery (FA) access have mixed results. Methods: Using a large state-wide database, 14,077 patients (8,539 with RA and 5,538 patents with FA access) were retrospectively compared to assess the occurrence of AKI following PCI. To reduce selection bias and balance clinical data across the two groups, a novel machine learning method called a Generalized Boosted Model was conducted on the arterial access site generating a weighted propensity score for each variable. A logistic regression analysis was then performed on the occurrence of AKI following PCI using the weighted propensity scores from the Generalized Boosted Model. Results: As shown in other studies, multiple variables were associated with an increase in AKI after PCI. Only RA access (OR 0.82; 95% CI 0.74-0.91) and male gender (OR 0.80; 95% CI 0.72-0.89) were associated with a lower occurrence of AKI. Based on the calculated Mehran scores, patients were stratified into groups with an increasing risk of AKI. RA access was consistently found to have a lower risk of AKI compared with FA access across these groups of increasing risk. Conclusions: Compared with FA access, RA access is associated with an 18% lower rate of AKI following PCI. This effect was observed among different levels of risk for developing AKI. Although developed from a retrospective analysis, this study supports the use of RA access when technically possible in a diverse group of patients.

Pathology of second-generation everolimus-eluting stents versus first-generation sirolimus- and paclitaxel-eluting stents in humans.

BACKGROUND: Clinical trials have demonstrated that the second-generation cobalt-chromium everolimus-eluting stent (CoCr-EES) is superior to the first-generation paclitaxel-eluting stent (PES) and is noninferior or superior to the sirolimus-eluting stent (SES) in terms of safety and efficacy. It remains unclear whether vascular responses to CoCr-EES are different from those to SES and PES because the pathology of CoCr-EES has not been described in humans. METHODS AND RESULTS: A total of 204 lesions (SES=73; PES=85; CoCr-EES=46) from 149 autopsy cases with duration of implantation >30 days and ≤3 years were pathologically analyzed, and comparison of vascular responses was corrected for duration of implantation. The observed frequency of late and very late stent thrombosis was less in CoCr-EES (4%) versus SES (21%; P=0.029) and PES (26%; P=0.008). Neointimal thickness was comparable among the groups, whereas the percentage of uncovered struts was strikingly lower in CoCr-EES (median=2.6%) versus SES (18.0%; P<0.0005) and PES (18.7%; P<0.0005). CoCr-EES showed a lower inflammation score (with no hypersensitivity) and less fibrin deposition versus SES and PES. The observed frequency of neoatherosclerosis, however, did not differ significantly among the groups (CoCr-EES=29%; SES=35%; PES=19%). CoCr-EES had the least frequency of stent fracture (CoCr-EES=13%; SES=40%; PES=19%; P=0.007 for CoCr-EES versus SES), whereas fracture-related restenosis or thrombosis was comparable among the groups (CoCr-EES=6.5%; SES=5.5%; PES=1.2%). CONCLUSIONS: CoCr-EES demonstrated greater strut coverage with less inflammation, less fibrin deposition, and less late and very late stent thrombosis compared with SES and PES in human autopsy analysis. Nevertheless, the observed frequencies of neoatherosclerosis and fracture-related adverse pathological events were comparable in these devices, indicating that careful long-term follow-up remains important even after CoCr-EES placement.

Transcatheter Mitral Valve Therapies in Patients with Mitral Annular Calcification.

Mitral annular calcification is a chronic process involving degeneration and calcium deposition within the fibrous skeleton of the mitral valve annulus, which can lead to mitral valve dysfunction. It can be asymptomatic, or it can have pathologic sequelae leading to cardiovascular morbidity and mortality. Mitral annular calcification is increasingly recognized with the advancement of diagnostic imaging modalities, especially in an era with a growing elderly population. Its presence poses considerable challenges in terms of surgical and transcatheter management. Multiple surgical and transcatheter techniques have been developed to overcome these challenges. New transcatheter technologies are under investigation to tackle this problem.

5-Year Outcomes of Anterior Mitral Leaflet Laceration to Prevent Outflow Obstruction.

BACKGROUND: Left ventricular outflow tract (LVOT) obstruction is a common, often fatal complication of transcatheter mitral valve replacement (TMVR). Laceration of the anterior mitral leaflet to prevent outflow obstruction (LAMPOON) was safe and effective at preventing LVOT obstruction at 30 days in the National Heart, Lung, and Blood Institute LAMPOON trial. OBJECTIVES: The authors report the 5-year outcomes of intentional anterior mitral leaflet laceration before SAPIEN 3 TMVR, in patients at risk of LVOT obstruction. METHODS: The National Heart, Lung, and Blood Institute LAMPOON trial was a prospective, multicenter, single-arm safety and feasibility study of LAMPOON and transseptal SAPIEN 3 TMVR in annuloplasty rings (valve-in-ring) or native mitral annular calcification (MAC) (valve-in-MAC). All subjects had high predicted risk for LVOT obstruction. Subjects were not excluded for excessive frailty or comorbidity. The primary endpoints were technical success and safety at 30 days. Secondary clinical and echocardiographic endpoints were assessed at 1 year and clinical follow-up at 5 years. RESULTS: Thirty subjects were enrolled between June 2017 and June 2018, equally between the valve-in-MAC and valve-in-ring arms. At 30 days, LAMPOON was successful in all 30 subjects, with no strokes, 1 (3%) death, and 1 (3%) moderate LVOT obstruction. Eighteen (65%) survived to 1 year, and 7 (25%) survived to 5 years. Six (20%) were hospitalized for heart failure in the first year. From baseline to 1 year, there was a 24-point improvement in Kansas City Cardiomyopathy Questionnaire score and a 60-m improvement in 6-minute walk distance. There was no significant change in N-terminal pro-brain natriuretic peptide. At 1 year, LVOT gradients remained low. CONCLUSIONS: LAMPOON enabled TMVR despite the risk for LVOT obstruction. There were no long-term complications associated with LAMPOON. The selection of inoperable patients limited assessment of long-term survival following TMVR. (NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation; NCT03015194).

Missed Connections: Identification of Atrial Septal Defect by MRI.

In this case report, we describe a 55-year-old female patient with worsening exertional dyspnea who is referred to the cardiology department, due to the appearance of worsening pulmonary vascular disease on computed tomography (CT) of the chest. Previous transthoracic echocardiograms (TTE) identified right ventricle enlargement, but no other structural abnormalities. She completed cardiac magnetic resonance (CMR) imaging, which identified a large secundum atrial septal defect (ASD). She subsequently underwent surgical planning and correction of the lesion with improvement of her symptoms. This case and a growing body of literature support the use of CMR as an alternative imaging modality for the diagnosis of congenital heart disease (CHD).

Stroke-Like Symptoms During Sexual Intercourse in a 25-Year-Old Female with a Patent Foramen Ovale.

A 25-year-old female who presented with stroke-like symptoms during sexual intercourse was found to have a patent foramen ovale (PFO). She was diagnosed with a cryptogenic transient ischemic attack (TIA) and underwent a successful catheter-based PFO closure. She had complete resolution of symptoms during both intercourse and physical activity.

Transcatheter Mitral Cerclage Ventriculoplasty: From Bench to Bedside.

BACKGROUND: Transcatheter mitral valve repair is beneficial in patients with mitral regurgitation (MR), left ventricular dysfunction, and persistent symptoms despite maximally tolerated medical therapy. OBJECTIVES: The aim of this study was to evaluate the safety and feasibility of transcatheter mitral cerclage ventriculoplasty in patients with MR and either heart failure with reduced ejection fraction or preserved ejection fraction and in subjects with prior edge-to-edge repair but persistent or recurrent symptomatic MR. METHODS: The National Heart, Lung, and Blood Institute Division of Intramural Research Transcatheter Mitral Cerclage Ventriculoplasty Early Feasibility Study (NCT03929913) was an investigator-initiated prospective multicenter study. The primary endpoint was technical success measured at exit from the catheterization laboratory. Follow-up included heart failure quality-of-life assessments and serial imaging with echocardiography and cardiac computed tomography. RESULTS: Nineteen subjects consented and underwent cerclage, 63% with heart failure with reduced ejection fraction and 37% with heart failure with preserved ejection fraction, with ischemic cardiomyopathy in 26% and nonischemic cardiomyopathy in 74%. There were no procedural deaths, strokes, or transient ischemic attacks or other major cardiovascular adverse events. The primary endpoint was met in 17 subjects. Cerclage induced sustained reductions in mitral regurgitant volume (-41%) and effective orifice area (-33%) after a median of 337 days. Cerclage resulted in improvements in 6-minute walking distance (+78 m) and Kansas City Cardiomyopathy Questionnaire Overall Summary Score (+22 points) at 30 days that were maintained after a median of 265 days. New complete heart block developed in 6 of 17 subjects. Three deaths occurred on postprocedural days 79, 159, and 756, unrelated to cerclage. CONCLUSIONS: Transcatheter mitral cerclage ventriculoplasty resulted in significant and sustained improvements in mitral regurgitation and in heart failure quality-of-life assessments.

Transcaval Versus Transaxillary TAVR in Contemporary Practice: A Propensity-Weighted Analysis.

OBJECTIVES: The aim of this study was to compare transcaval and transaxillary artery access for transcatheter aortic valve replacement (TAVR) at experienced medical centers in contemporary practice. BACKGROUND: There are no systematic comparisons of transcaval and transaxillary TAVR access routes. METHODS: Eight experienced centers contributed local data collected for the STS/ACC TVT Registry (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry) between 2017 and 2020. Outcomes after transcaval and axillary/subclavian (transaxillary) access were adjusted for baseline imbalances using doubly robust (inverse propensity weighting plus regression) estimation and compared. RESULTS: Transcaval access was used in 238 procedures and transaxillary access in 106; for comparison, transfemoral access was used in 7,132 procedures. Risk profiles were higher among patients selected for nonfemoral access but similar among patients requiring transcaval and transaxillary access. Stroke and transient ischemic attack were 5-fold less common after transcaval than transaxillary access (2.5% vs 13.2%; OR: 0.20; 95% CI: 0.06-0.72; P = 0.014) compared with transfemoral access (1.7%). Major and life-threatening bleeding (Valve Academic Research Consortium 3 ≥ type 2) were comparable (10.0% vs 13.2%; OR: 0.66; 95% CI: 0.26-1.66; P = 0.38) compared with transfemoral access (3.5%), as was blood transfusion (19.3% vs 21.7%; OR: 1.07; 95% CI: 0.49-2.33; P = 0.87) compared with transfemoral access (7.1%). Vascular complications, intensive care unit and hospital length of stay, and survival were similar between transcaval and transaxillary access. More patients were discharged directly home and without stroke or transient ischemic attack after transcaval than transaxillary access (87.8% vs 62.3%; OR: 5.19; 95% CI: 2.45-11.0; P < 0.001) compared with transfemoral access (90.3%). CONCLUSIONS: Patients undergoing transcaval TAVR had lower rates of stroke and similar bleeding compared with transaxillary access in a contemporary experience from 8 US centers. Both approaches had more complications than transfemoral access. Transcaval TAVR access may offer an attractive option.

Valve-in-Valve Transcatheter Aortic Valve Replacement, with Present-Day Innovations and Up-to-Date Techniques.

Approximately 51,000 to 65,000 surgical aortic valve replacement (SAVR) cases are performed in the United States anually. Bioprosthetic degeneration commonly occurs within 10 to 15 years, and nearly 800 redo SAVR cases occur each year. Valve-in-valve transcatheter aortic valve replacement (ViV TAVR) has emerged as a safe and effective alternative, as the Food and Drug Administration approved ViV TAVR with self-expanding transcatheter heart valve in 2015 and balloon-expandable valve in 2017 for failed surgical valves cases at high risk of reoperation. We review ViV TAVR, with specific attention to procedural planning, technical challenges, associated complications, and long-term follow-up.

Postmortem in situ micro-CT evaluation of coronary stent fracture.

UNLABELLED: Coronary stent fracture has been postulated as an important mechanism for in-stent restenosis and late-stent thrombosis. We have developed a nondestructive microcomputed tomography (micro-CT) technique to image en bloc stented arterial segments. CASE REPORT: A 43-year-old man died of sepsis 5 months following placement of a paclitaxel-eluting stent (PES) in the left circumflex coronary artery to treat in-stent restenosis of a sirolimus-eluting stent (SES). Micro-CT three-dimensional images of the overlapping stents were notable for numerous connecting element fractures along the length of the SES. No fractures were observed in the PES. The greatest area of luminal narrowing is related to the region of most extensive stent fracture. Micro-CT of en bloc specimens provides high resolution (16 µm), three-dimensional images allowing for visualization of the stented arterial segment in a nondestructive manner.

3D printing tissue-mimicking materials for realistic transseptal puncture models.

Applications of additive manufacturing (commonly referred to as 3D printing) in direct fabrication of models for pre-surgical planning, functional testing, and medical training are on the rise. However, one current limitation to the accuracy of models for cardiovascular procedural training is a lack of printable materials that accurately mimic human tissue. Most of the available elastomeric materials lack mechanical properties representative of human tissues. To address the gap, the authors explore the multi-material capability of material jetting additive manufacturing to combine non-curing and photo-curing inks to achieve material properties that more closely replicate human tissues. The authors explore the impact of relative material concentration on tissue-relevant properties from puncture and tensile testing under submerged conditions. Further, the authors demonstrate the ability to mimic the mechanical properties of the fossa ovalis, which proves beneficial for accurately simulating transseptal punctures. A fossa ovalis mimic was printed and assembled within a full patient-specific heart model for validation, where it exhibited accuracy in both mechanical properties and geometry. The explored material combination provides the opportunity to fabricate future medical models that are more realistic and better suited for pre-surgical planning and medical student training. This will ultimately guide safer, more efficient practices.

A case series: alternative access for refractory shock during cardiac arrest.

BACKGROUND: In patients with iliofemoral arterial disease, transcaval and percutaneous axillary artery access are safe alternatives for delivery of transcatheter aortic valve replacement for severe aortic stenosis. In the setting of cardiac arrest, arterial access is crucial for delivery of mechanical circulatory support devices such as an Impella CP® or cannulation for extracorporeal cardiopulmonary resuscitation (ECMO). We report the use of transcaval and axillary artery access in three cases of cardiac arrest in which the emergent placement of an Impella CP® (Abiomed, Danvers, MA, USA) or cannulation for ECMO was instrumental in resuscitation from refractory cardiac arrest. CASE SUMMARY: The first patient is a 59-year-old woman who developed ventricular fibrillation arrest after percutaneous intervention with emergent placement of a transcaval Impella CP®. In the second case, a 67-year-old man with coronary vasospasm developed cardiac arrest with an axillary artery Impella CP® placed. The third case highlights a 67-year-old man who developed cardiac arrest 1 day after unsuccessful chronic total occlusion repair requiring ECMO cannulation to his axillary artery. All three patients achieved spontaneous circulation after placement of assist devices. DISCUSSION: To our knowledge, a case report of transcaval or percutaneous axillary artery access for Impella CP® during cardiac arrest has not been published. While the long-term prognosis following cardiac arrest is poor, younger patients deserve every chance for survival with rapid cardiopulmonary support by alternative access if necessary. Advanced large bore alternative access techniques should be learned by all interventional operators.

Anterior Leaflet Laceration to Prevent Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Replacement.

BACKGROUND: Left ventricular outflow tract (LVOT) obstruction is a leading cause of mortality and exclusion from transcatheter mitral valve replacement (TMVR). Intentional laceration of the anterior mitral valve leaflet to prevent LVOT obstruction (LAMPOON) is a transcatheter mimic of surgical chord-sparing leaflet resection. OBJECTIVES: The purpose of this prospective multicenter trial was to study LAMPOON with transseptal (Edwards Lifesciences, Irvine, California) TMVR in annuloplasty rings or native mitral annular calcification (MAC). METHODS: Subjects at high or extreme surgical risk and prohibitive risk of LVOT obstruction from TMVR were included. Eligibility was modified midtrial to exclude subjects with threatened LVOT obstruction from a Sapien 3 valve fabric skirt. The primary endpoint was procedure survival with successful LAMPOON, with successful TMVR, without reintervention, and with LVOT gradient <30 mm Hg ("optimal") or <50 mm Hg ("acceptable"). Secondary endpoints included 30-day mortality and major adverse cardiovascular events. There was universal source-data verification and independent monitoring. All endpoints were independently adjudicated. Central laboratories analyzed echocardiogram and CT images. RESULTS: Between June 2017 and June 2018, 30 subjects were enrolled equally between the MAC and ring arms. LAMPOON traversal and midline laceration was successful in 100%. Procedure survival was 100%, and 30-day survival was 93%. Primary success was achieved in 73%, driven by additional procedures for paravalvular leak (10%) and high-skirt neo-LVOT gradients observed before a protocol amendment. There were no strokes. CONCLUSIONS: LAMPOON was feasible in native and annuloplasty ring anatomies in patients who were otherwise ineligible for treatment, with acceptable safety. LAMPOON was effective in preventing LVOT obstruction from TMVR. Despite LAMPOON, TMVR using Sapien 3 in annuloplasty rings and MAC still exhibits important limitations. (NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation; NCT03015194).

Safety and predictors of next-day discharge after elective transfemoral transcatheter aortic valve replacement.

OBJECTIVES: We sought to determine the predictors of next-day discharge (NDD) for selected patients undergoing elective transfemoral transcatheter aortic valve replacement (TF-TAVR). BACKGROUND: Techniques have rapidly evolved over the last several years to simplify TF-TAVR allowing for a subset of patients to be discharged the next day. METHODS: Baseline and procedural characteristics, in-hospital and 30-day follow-up outcomes, complications and readmission rates of 100 TF-TAVR cases were assessed. Patients selected for NDD all met the following criteria: no procedural complications, same day ambulation, strong family support with home supervision, and access to our valve coordinator post discharge. RESULTS: There were 22 patients in NDD and 78 in later-day discharge (LDD) groups respectively. The mean length of stay was 3.4days for LDD. There were no significant differences in baseline, pre-procedural characteristics, or frailty indices of the two groups. However, there were more baseline oxygen dependent patients in LDD (p=0.004). Procedural characteristics included more balloon expandable valves (p=0.005), less fluoroscopy time (p=0.008), and higher use of moderate sedation (p=0.0001) in NDD group. There were more minor vascular complications (p=0.04) and new permanent pacemaker implantations (p=0.016) in the LDD group. There were no vascular complications, stroke or blood transfusions in the NDD group. The 30-day re-admission and mortality rates were similar in both groups. In logistic analyses only moderate sedation was a strong predictor of next day discharge after TF-TAVR (p=0.003). CONCLUSION: Carefully selected patients without complications following TF-TAVR can be discharged safely the next day.

Minor defects of the luminal integrity in arterial introducer eSheaths after transcatheter aortic valve implantation.

BACKGROUND: Medical devices such as implant delivery systems are commonly used during minimally invasive procedures in the cardiovascular system. These devices often have lubricious polymer coatings to reduce friction between the device and blood vessels but coatings may separate and potentially cause serious injuries to patients. METHODS: Lubricious coated eSheaths for transcatheter heart valve implantation were assessed for luminal integrity at the proximal, medial and distal part. We assessed the number, depths and area of luminal trails using environmental scanning electron microscope (ESEM), white light interferometry (WLI) and optical profilometry using area scale fractal complexity (asfc) as surface parameters. A total of 15 eSheaths were retrieved and analyzed after successful femoral transcatheter Sapien 3 implantation in patients (23 mm valve- 14F eSheath, 26 mm valve- 14F eSheath and 29 mm valve- 16F eSheath, n = 5 for each group). Unused eSheaths (14F and 16F) served as controls (n = 5 for each group). RESULTS: ESEM revealed significantly greater number of trails after TAVR passage with the 23 mm, 26 mm and 29 mm valves compared to unused control 14F and 16F eSheaths (13.9 ± 3.1, 14.2 ± 2.3, 15.8 ± 1.7 vs. 0.08 ± 0.1 and 1.0 ± 0.5 [n]; p ≤ 0.0001 for all comparisons). Similarly, WLI showed minor, but significantly greater areas of luminal defects after 23 mm, 26 mm and 29 mm valve implantation vs. 14F and 16F unused controls (7.5 ± 0.9, 10.3 ± 1.1, 10.4 ± 1.4 vs. 4.1 ± 0.4 and 2.2 ± 0.4 [µm2], p = 0.0081). Likewise, the 3D-surface-measurement showed comparable results after implantation of the 23 mm, 26 mm and 29 mm valves vs. 14F and 16F unused control eSheaths (79.5 ± 6.3, 105.9 ± 5.3, 98.8 ± 4.8 vs. 5.1 ± 2.8 and 5.6 ± 0.5 [asfc] p = 0.0001). CONCLUSION: Measurable defects of the luminal layer occur during balloon expandable TAVR using 14F and 16F eSheaths though this is likely clinically insignificant. Further clinical investigations including a prospective assessment of minor peripheral embolization are needed to fully address the impact of this luminal defects.