Guerrero, Mayra

Background: Transcatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical repairs with annuloplasty rings or severe mitral annular calcification who are poor surgical candidates. Outcomes of these procedures are collected in the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry. A comprehensive analysis of mitral valve-in-valve (MViV), mitral valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) outcomes has not been performed. We sought to evaluate short-term outcomes of early experience with MViV, MViR, and ViMAC in the United States. Methods: Retrospective analysis of data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Results: Nine hundred three high-risk patients (median Society of Thoracic Surgeons score 10%) underwent MViV (n=680), MViR (n=123), or ViMAC (n=100) between March 2013 and June 2017 at 172 hospitals. Median age was 75 years, 59.2% female. Technical and procedural success were higher in MViV. Left ventricular outflow tract obstruction occurred more frequently with ViMAC (ViMAC=10%, MViR=4.9%, MViV=0.7%; P <0.001). In-hospital mortality (MViV=6.3%, MViR=9%, ViMAC=18%; P =0.004) and 30-day mortality (MViV=8.1%, MViR=11.5%, ViMAC=21.8%; P =0.003) were higher in ViMAC. At 30-day follow-up, median mean mitral valve gradient was 7 mm Hg, most patients (96.7%) had mitral regurgitation grade ≤1 (+) and were in New York Heart Association class I to II (81.7%). Conclusions: MViV using aortic balloon-expandable transcatheter heart valves is associated with a low complication rate, a 30-day mortality lower than predicted by the Society of Thoracic Surgeons score, and superior short-term outcomes than MViR and ViMAC. At 30 days, patients in all groups experienced improvement of symptoms, and valve performance remained stable. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02245763.

Objective A subset of patients at the time of transcatheter mitral valve repair (TMVR) will have normal left atrial pressure (LAP) (<13 mm Hg) despite having severe mitral regurgitation (MR). The goal of this study was to determine clinical characteristics and outcomes in patients with normal LAP undergoing TMVR. Methods A single-centre retrospective cohort of consecutive patients who underwent transcatheter edge-to-edge mitral valve clip and continuous LAP monitoring between 5/1/2014 and 5/1/2018 was analysed. One-year mortality was compared by Kaplan–Meier survival curves. Multivariable analysis was performed to identify predictors of normal LAP and 1 year mortality. Results Of the 204 patients undergoing TMVR, 65% were men and the mean age was 81. Of these patients, 31 (15%) had normal LAP (mean LAP 10.5 mm Hg, mean V wave 16.5 mm Hg) and 173 had elevated LAP (mean LAP 19 mm Hg, mean V wave 32.5 mm Hg). The prevalence of severe MR was not different between groups, although the normal LAP group had significantly lower effective regurgitant orifice area and regurgitant volume. Other notable baseline characteristics including prior cardiac surgery, atrial fibrillation, hypertension, diabetes, congestive heart failure, body mass index, mechanism of MR and ejection fraction were similar between groups. However, there was an increased prevalence of chronic lung disease (CLD) (45.2% vs 17.3%, p<0.001) in the normal LAP group. On multivariate analysis, the only significant predictor of normal LAP was the presence of CLD (OR 4.79 (1.83–12.36), p=0.001) and 1-year mortality was significantly higher in the normal LAP group (32.3% vs 12.7%, p=0.006). After adjustment for comorbidities, normal LAP was no longer a predictor of 1-year mortality (RR 1.62 (0.64–4.06), p=0.32); however, CLD (RR 3.44 (1.37–8.67), p=0.01) remained a statistically significant predictor. Conclusion Normal LAP at the time of TMVR is associated with a higher incidence of CLD which independently predicts increased 1-year mortality. In patients with CLD and apparently severe MR, measurement of LAP may help identify those with lower likelihood of benefit from TMVR.

AbstractObjectivesTo examine the safety of utilizing transapical access during structural interventions.BackgroundComplex interventions of the mitral or aortic region sometimes require coaxial forces to orient and deliver devices. Apical access can provide coaxial countertraction for either transseptal or retrograde aortic access. This manuscript describes the single center experience of small bore transapical access.MethodsRetrospective review of cases from 2013 to 2018 at Henry Ford Hospital was performed. Patient demographics and procedure characteristics were abstracted to describe the safety of transapical access using small bore sheaths.ResultsA total 21 cases were performed at Henry Ford, most of them for transcatheter mitral valve replacement (81%). The mean sheath size used was 4.7 ± 0.9 Fr and protamine was used at the end of 57% of cases. All patients received nitinol‐based plugs, 80.1% were from the Amplatz Duct Occluder II type. Four major complications related apical puncture occurred, two pericardial effusions, two hemothorax. Over a median follow time of 430 days (IQR 50–652) a total of five deaths occurred, two related to the procedure and three late deaths with a median time of 362 days (range 205–628 days). No deaths were associated with transapical access. Echocardiographic follow up did not detect any late structural complications from occluder devices.ConclusionsTransapical access and closure with nitinol‐based devices is feasible and facilitates complex interventions where coaxial forces are need for device delivery and alignment. The most common complication is bleeding and this should be kept in perspective when treating high‐risk patients.

AbstractTranscatheter tricuspid valve in valve (TViV) is increasingly performed on patients with degenerated bioprosthetic valves and elevated surgical risk. Jailing a right ventricular (RV) pacer lead at the time of TViV implantation has been achieved without causing lead dysfunction; however, device‐related complications that require lead extraction raise the need for better periprocedural strategies for TViV, in pacer‐dependent patients. We describe a case of device pocket infection with incomplete lead extraction, due to a jailed RV lead at the time of TViV.

AbstractObjectiveTo describe the hemodynamic and early clinical outcomes of percutaneous alcohol septal ablation in patients with concomitant dynamic left ventricular outflow tract (LVOT) obstruction and aortic valvular stenosis (AS).BackgroundAlcohol septal ablation is an established method to relieve dynamic LVOT obstruction in patients with hypertrophic cardiomyopathy (HCM). However, the feasibility, safety, and efficacy of alcohol septal ablation in patients with serial obstructions from HCM and AS remain unclear.MethodsIn this case series, we describe the early outcomes of alcohol septal ablation in six patients with significant dynamic LVOT obstruction and AS. All patients had evidence of severe dynamic LVOT obstruction (resting or provoked gradient ≥50 mmHg), mild to severe AS, and NYHA class III symptoms or greater.ResultsFour (66.7%) patients had septal ablation performed in the setting of concomitant native valvular AS and two (33.3%) patients had TAVR performed prior to septal ablation. Successful alcohol septal ablation was performed in all patients and was associated with an immediate reduction of the dynamic LVOT gradient with a residual fixed obstruction related to AS. Four (66.7%) patients had follow‐up at 1 month and of these, three (75%) had NYHA Class I–II symptoms and one (25%) Class III.ConclusionsAlcohol septal ablation is a feasible method of relieving dynamic LVOT obstruction in patients with concomitant HCM and AS. Further study is required to determine the optimal treatment approach in these patients.

Background: Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device. Methods and Results: A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%). Conclusions: In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.

Abstract Aims To investigate valve sizing and the haemodynamic relevance of the predicted left ventricular outflow tract (LVOT) in patients with mitral annular calcification (MAC) undergoing transatrial transcatheter valve implantation (THV). Methods and results In total, 21 patients undergoing transatrial THV, multiplanar reconstruction (MPR), maximum intensity projection (MIP), and cubic spline interpolation (CSI) were compared for MA sizing during diastole. In addition, predicted neo-LVOT areas were measured in 18 patients and correlated with the post-procedural haemodynamic dimensions. The procedure was successful in all patients (100%). Concomitant aortic valve replacement was performed in eight patients (43%) (AVR group). Sizing using MPR and MIP yielded comparable results in terms of area, perimeter, and diameter, whereas the dimensions obtained with CSI were systematically smaller. The simulated mean systolic neo-LVOT area was 133.4 ± 64.2 mm2 with an anticipated relative LVOT area reduction (neo-LVOT area/LVOT area × 100) of 59.3 ± 14.7%. The systolic relative LVOT area reduction, but not the absolute neo-LVOT area, was found to predict the peak (r = 0.69; P = 0.002) and mean (r = 0.65; P = 0.004) post-operative aortic gradient in the overall population as well as separately in the AVR (peak: r = 0.91; P = 0.002/mean: r = 0.85; P = 0.002) and no-AVR (peak: r = 0.89; P = 0.003/mean: r = 0.72; P = 0.008) groups. Conclusion In patients with severe MAC undergoing transatrial transcatheter valve implantation, MPR, and MIP yielded comparable annular dimensions, while values obtained with CSI tended to be systematically smaller. Mitral annular area and the average annular diameter appear to be reliable parameters for valve selection. Simulated relative LVOT reduction was found to predict the post-procedural aortic gradients.

AbstractObjectiveTo understand the clinical and hemodynamic response of patients with stenotic versus regurgitant prosthetic mitral valve degeneration to transseptal transcatheter mitral valve‐in‐ring/‐valve replacement (TMVR).BackgroundPatients with prosthetic mitral valve repair/replacement failure frequently present high‐risk surgical challenges. TMVR has been employed as an alternative to surgery.MethodsForty‐four patients with stenotic/regurgitant degeneration of prior prosthetic mitral annuloplasty and replacement (38) underwent mitral TMVR. Clinical, echocardiographic, and invasive hemodynamic monitoring was conducted at baseline and follow‐up.ResultsRelative to patients with regurgitant degeneration (28), patients with stenotic degeneration had baseline higher mitral valve gradients (12 ± 4 vs. 7 ± 3 mmHg, p < 0.01) and smaller areas (1.0 ± 0.4 vs. 1.5 ± 0.4 cm2, p = 0.01). TMVR yielded significant reduction in left atrial v‐wave pressures in stenotic and regurgitant cohorts (−7 ± 11, p = 0.03, and −11 ± 12 mmHg, p < 0.01, respectively) and significant, sustained symptomatic improvement. Intracardiac pressures overall, including left ventricular end diastolic pressures, remained elevated.ConclusionDespite baseline differences in valvular disease, TMVR leads to significant hemodynamic and clinical improvement in both stenotic and regurgitant prosthetic mitral valve disease. In both cohorts, TMVR reduced intracardiac pressures to similar postprocedural levels, but pressures remained supranormal. This outcome suggests a multifactorial process defines the pathophysiology of patients undergoing TMVR, including contributions from prosthetic degeneration, changes in left atrial compliance, and diastolic dysfunction, and highlights the need to consider such factors in patient evaluation and treatment.

AbstractLeft ventricular pseudoaneurysm is an infrequent but potentially fatal complication following cardiac surgery, with spontaneous rupture being the most feared result. Moreover, surgical repair is associated with significant morbidity and mortality. We present a successful transapical percutaneous closure of a post‐surgical rapidly expanding left ventricular outflow tract (LVOT) pseudoaneurysm utilizing Amplatz Vascular Plug‐II (AVP‐II) (St. Jude Medical, St. Paul, MN) with the aid of 3D prototyping for pre‐procedural planning.

AbstractBackgroundTreatment of hemodynamically significant mitral annular calcification (MAC) using transcatheter approaches is in the early learning phase. The occurrence of paravalvular leak (PVL) following transcatheter mitral valve in MAC is common.AimsTo report the initial experience and techniques of percutaneous PVL closure after transcatheter valve in MAC.MethodsThis series includes five consecutive patients who underwent percutaneous PVL closure following transcatheter balloon expandable SAPIEN S3 valve in MAC.ResultsMean patient age was 73.6 ± 5.4 years (4 [80%] female), with average Society of Thoracic Surgeons score of 8.1 ± 2.8%. Three patients had a single PVL defect while two patients had two defects; all were located at the commissural sites. Closure was performed primarily for heart failure in four patients and hemolytic anemia in one patient. Transfemoral transseptal antegrade approach and Amplatz Vascular Plug (AVP)‐II occluders were utilized in all patients. Procedure success was achieved in three patients. One patient developed significant occluder related leaflet impingement and subsequent severe prosthetic mitral regurgitation requiring a second transcatheter mitral valve in valve implantation. The procedure was aborted in one patient due to difficulty crossing PVL defect after balloon post‐dilatation of SAPIEN prosthesis with 10 mL of additional volume. There was no in hospital or 30 day mortality or the need for emergent surgery.ConclusionEarly experience with percutaneous PVL closure of SAPIEN valve in MAC demonstrated feasibility of this approach. Careful procedure planning and monitoring for SAPIEN prosthesis leaflet impingement and frame instability is of utmost importance to increase the chances of procedural success.