Minimalist transcatheter aortic valve replacement misses paravalvular regurgitation: Incidence and echocardiographic distribution of missed paravalvular regurgitation.

BACKGROUND: Paravalvular regurgitation (PVR) may be missed intraoperatively with transthoracic echocardiography (TTE) guided minimalist TAVR. We sought to determine the incidence and echocardiographic distribution of PVR missed on intra-op TTE, but detected on predischarge TTE. METHODS: From July 2015 to 2020, 475 patients with symptomatic severe native aortic stenosis underwent TTE-guided minimalist TAVR. Missed PVR was defined as predischarge PVR that was ≥1 grade higher than the corresponding intra-op PVR severity. PVR was classified as anterior or posterior on the four standard TTE views; parasternal short-axis (PSAX), parasternal long-axis (PLAX), apical 3-chamber (A3C), and 5-chamber (A5C). Location-specific risk of missed PVR was then determined. RESULTS: Mild or greater PVR was seen in 55 (11.5%) cases intra-op and 91 (19.1%) at predischarge, with no severe PVR. Among the 91 patients with ≥mild predischarge PVR, missed PVR was present in 42 (46.2%). Compared to the corresponding anterior jets, missed PVR rate was significantly higher for posterior jets in PLAX (62.5% vs. 25.0%, p = 0.005), A5C (56.9% vs. 25.0%, p = 0.009), PSAX (66.7% vs. 24.3%, 0.001), but not A3C (58.5% vs. 40.0%, p = 0.28). CONCLUSIONS: Intraoperative TTE-guided minimalist TAVR either misses nearly half of ≥mild PVR or underestimates PVR by ≥1 grade when compared to predischarge TTE. Posterior PVR jets are more likely to be missed. Transesophageal echo guidance may help minimize missing PVR. Further studies are warranted.

Alignment of Transcatheter Aortic-Valve Neo-Commissures (ALIGN TAVR): Impact on Final Valve Orientation and Coronary Artery Overlap.

OBJECTIVES: The aim of this study was to evaluate the impact of initial deployment orientation of SAPIEN 3, Evolut, and ACURATE-neo transcatheter heart valves on their final orientation and neocommissural overlap with coronary arteries. BACKGROUND: Coronary artery access and redo transcatheter aortic valve replacement (TAVR) following initial TAVR may be influenced by transcatheter heart valve orientation. In this study the impact of transcatheter heart valve deployment orientation on commissural alignment was evaluated. METHODS: Pre-TAVR computed tomography and procedural fluoroscopy were analyzed in 828 patients who underwent TAVR (483 SAPIEN 3, 245 Evolut, and 100 ACURATE-neo valves) from March 2016 to September 2019 at 5 centers. Coplanar fluoroscopic views were coregistered to pre-TAVR computed tomography to determine commissural alignment. Severe overlap between neocommissural posts and coronary arteries was defined as 0° to 20° apart. The SAPIEN 3 had 1 commissural post crimped at 3, 6, 9, and 12 o'clock. The Evolut "Hat" marker and ACURATE-neo commissural post at deployment were classified as center back (CB), inner curve (IC), outer curve (OC), or center front (CF) and matched with final orientation. RESULTS: Initial SAPIEN 3 crimped orientation had no impact on commissural alignment. Evolut "Hat" at OC or CF at initial deployment had less severe overlap than IC or CB (p < 0.001) against the left main (15.7% vs. 66.0%) and right coronary (7.1% vs. 51.1%) arteries. Tracking Evolut "Hat" at OC of the descending aorta (n = 107) improved OC at deployment from 70.2% to 91.6% (p = 0.002) and reduced coronary artery overlap by 36% to 60% (p < 0.05). ACURATE-neo commissural post at CB or IC during deployment had less coronary artery overlap compared to CF or OC (p < 0.001), with intentional alignment successful in 5 of 7 cases. CONCLUSIONS: This is the first systematic evaluation of commissural alignment in TAVR. More than 30% to 50% of cases had overlap with 1 or both coronary arteries. Initial SAPIEN 3 orientation had no impact on alignment, but specific initial orientations of Evolut and ACURATE improved alignment. Optimizing valve alignment to avoid coronary artery overlap will be important in coronary artery access and redo TAVR.

Novel Anatomic Predictors of New Persistent Left Bundle Branch Block After Evolut Transcatheter Aortic Valve Implantation.

New persistent left bundle branch block (NP-LBBB) has been associated with adverse outcomes after TAVI but few predictors thus far reported. We sought to identify predictors of NP-LBBB after TAVI with EvolutR/PRO (ER/EP). From 1/2016 to 4/2019, 544 patients from 2 centers underwent TAVI with Evolut (54% ER, 46% EP) for severe native aortic stenosis. Patients with previous LBBB and pacemaker were excluded. Aortic root analysis was performed using 3Mensio Valves Software and membranous septal length (MSL) was determined using the standard coronal view. Clinical, anatomic and procedural characteristics of 396 Evolut were analyzed and predictors of NP-LBBB were identified. Valve Academic Research Consortium-2 outcomes were reported. At discharge, NP-LBBB was seen in 76(19.2%) patients. NP-LBBB in Evolut was associated with implant depth at left coronary cusp (p = 0.004) and 34 mm ER (p = 0.026). Independent predictors of NP-LBBB in Evolut were shorter MSL (odds ratio [OR] = 0.82 per mm septum, 95% confidence interval [CI] = 0.68 to 0.98,p = 0.030), left ventricular outflow tract (LVOT) eccentricity (OR = 1.04 per %, 95% CI = 1.01 to 1.06,p = 0.002), implant depth at noncoronary cusp (NCC) (OR = 1.28 per mm ventricular, 95% CI = 1.11 to 1.48,p = 0.001) and annular perimeter oversizing ≥20% (OR = 2.38, 95% CI = 1.20 to 4.72, p = 0.013). On ROC curve analysis, MSL ≤6.5 mm, NCC depth ≥3 mm and LVOT eccentricity ≥35% were optimal threshold values to predict NP-LBBB. In Conclusion, shorter MSL, LVOT eccentricity, annular oversizing and deeper implant depth are novel predictors of NP-LBBB in Evolut TAVI. Preprocedural CT assessment of aortic root anatomy may help identify patients at risk for NP-LBBB. In such patients, modifying procedural factors such as higher implant and less annular oversizing may reduce the risk of NP-LBBB. Further evaluation of our hypothesis is warranted.

A meta-analysis of 1-year outcomes of transcatheter versus surgical aortic valve replacement in low-risk patients with severe aortic stenosis.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) for the treatment symptomatic severe aortic stenosis (AS) is indicated in patients with intermediate or higher surgical risk. Latest trials showed TAVR, and surgical aortic valve replacement (SAVR) perform similarly at 1-year for the composite outcomes of mortality, stroke and rehospitalization. We performed a comprehensive meta-analysis to compare individual outcomes at 1-year for TAVR compared to SAVR in low-risk patients. METHODS: PubMed, Embase, and Cochrane central were searched for all the randomized controlled trials (RCTs) that reported 1-year comparative outcomes of TAVR and surgical aortic valve replacement (SAVR). Our conclusions are based upon the random-effects model using DerSimonian-Laird estimator. RESULTS: Data from 4 trials and 2887 randomized patients showed that TAVR had lower rates of all-cause mortality, cardiovascular mortality, and atrial fibrillation compared to SAVR at 1-year follow-up (P < 0.05 for all). Also, TAVR was also associated with a significantly higher risk of permanent pacemaker implantation and moderate-severe paravalvular leak (P < 0.05). CONCLUSIONS: The latest randomised trial data demonstrates that in short-term, TAVR is safe and effective in reducing all-cause mortality or stroke. Longer follow-up of RCTs is needed to determine the durability of clinical benefits in TAVR over SAVR in low-risk patients.

Continuous invasive hemodynamic monitoring using steerable guide catheter to optimize mitraclip transcatheter mitral valve repair: A multicenter, proof-of-concept study.

OBJECTIVES: We report our multicenter experience on continuous hemodynamic monitoring using exclusively the steerable guide catheter (SGC) during MitraClip repair. BACKGROUND: Left atrial pressure (LAP) and V-wave are useful to evaluate MitraClip repair but no simple method of continuous monitoring exists. METHODS: From 11/2016 to 8/2017, 74 patients from four centers with symptomatic moderate-severe to severe mitral regurgitation (MR), underwent MitraClip NT repair with continuous hemodynamic monitoring via the SGC. Real-time LAP/V-wave changes were compared with transesophageal echocardiography (TEE). When mitral stenosis was suspected, transmitral gradients were verified by invasive hemodynamics. Clinical and echocardiographic outcomes were determined. RESULTS: Mean age was 78 ± 10 years and STS score 9.1 ± 11.0%. Pathology included leaflet prolapse/flail (45%), restriction (35%), and mixed (20%). Number of clips averaged 1.7 ± 0.7 per case. There was a significant reduction in LAP (21 ± 10 to 15 ± 7 mmHg, P < 0.0001) and V-wave(37 ± 19 to 24 ± 10 mmHg, P < 0.0001) post MitraClip, but the decrease was less in patients with atrial fibrillation (P < 0.05). Transmitral gradient significantly increased from 2.0 ± 1.2 to 4.0 ± 1.7 mmHg (P < 0.0001). Paradoxical increases in LAP and V-wave despite MR reduction were observed in three cases requiring MitraClip repositioning or retrieval to avoid stenosis. Follow-up averaged 5.0 ± 2.9 months and was 100% complete. KCCQ improvement was significant and MR reduction to <1+ was 67% and <2+ was 93% at 30 days. CONCLUSIONS: Continuous hemodynamic monitoring using the SGC complements TEE to assess and optimize MitraClip repair in real-time. Further validation is necessary but this feature may be part of future MitraClip and other transcatheter mitral repair systems.

Novel predictors of mild paravalvular aortic regurgitation in SAPIEN 3 transcatheter aortic valve implantation.

AIMS: Paravalvular leak (PVL) remains an important issue in TAVI. The Edwards SAPIEN 3 (S3) valve has reduced PVL but in up to one third of patients mild leak remains. Our study aimed to identify predictors of mild PVL after TAVI with the S3 valve. METHODS AND RESULTS: From October 2015 to May 2017, 122 consecutive patients underwent S3 TAVI for symptomatic severe aortic stenosis. Thirty-three patients with mild PVL on transthoracic echocardiography at 30-day follow-up were compared to 89 with none/trace PVL. Thirty-day mortality was 2.5% (n=3), with zero stroke and major vascular complications. There were no differences between the two groups in patient characteristics, annular and left ventricular outflow tract (LVOT) sizing, distribution and severity of annular calcification, valve implantation technique, post-dilatation and implant depth. Mild PVL was associated with higher annular eccentricity (p=0.04) and moderate-severe LVOT calcification (p=0.03). Independent predictors of mild PVL were LVOT eccentricity (OR 1.05 per % ellipticity, 95% CI: 1.02-1.09, p=0.005), discordant sizing (OR 3.08, 95% CI: 1.20-7.90, p=0.02) and three-leaflet calcification (OR 13.3, 95% CI: 2.66-66.7, p=0.002). CONCLUSIONS: LVOT eccentricity and discordant sizing predict PVL after S3 TAVI. Further studies are needed to understand their mechanism and significance.

Afterload mismatch after transcatheter mitral valve repair with MitraClip for degenerative mitral regurgitation in acute cardiogenic shock.

Acute afterload mismatch after surgery for mitral regurgitation (MR) with transient left ventricular dysfunction is well known, but not described after transcatheter mitral valve repair with MitraClip, except in functional MR and cardiomyopathy. MitraClip to manage acute severe MR and cardiogenic shock has also been rarely reported. We report here a 77-year-old female who presented with acute severe degenerative MR from a flail posterior leaflet, with cardiogenic shock requiring intra-aortic balloon pump support. She was medically stabilized and underwent successful MitraClip repair with mild residual MR, but developed acute afterload mismatch and severe left ventricular dysfunction and shock 24 hr after her procedure. Patient was medically managed with intra-aortic balloon pump and inotropic support. She subsequently fully recovered with normal ventricular function and was discharged after 14 days. Patient remained asymptomatic in NYHA I functional class 9 months after MitraClip repair, with mild residual MR and normal ventricular function. MitraClip repair in patients with acute severe degenerative MR and cardiogenic shock is a less invasive and potentially safer alternative to open surgery, but acute afterload mismatch may occur and requires prompt diagnosis and management for a successful outcome. © 2017 Wiley Periodicals, Inc.

First percutaneous Micra leadless pacemaker implantation and tricuspid valve repair with MitraClip NT for lead-associated severe tricuspid regurgitation.

AIMS: Pacemaker lead-associated severe tricuspid regurgitation (TR) can lead to right heart failure and poor prognosis. Surgery in these patients carries significant morbidities. We describe a successful treatment of symptomatic severe TR by leadless pacemaker implantation followed by tricuspid valve (TV) repair with the MitraClip NT. METHODS AND RESULTS: A 71-year-old frail female with poor functional status, chronic atrial fibrillation and permanent pacemaker implantation in 2012 presented with symptomatic moderate-severe mitral regurgitation (MR) and severe TR with the pacemaker lead as the culprit. She was deemed extreme risk for double valve surgery and, because of her pacemaker dependency, the decision was to stage her interventions first with transcatheter mitral repair, then laser lead extraction and leadless pacemaker implantation to free the TV from tethering, then TV repair. An obstructive LAD lesion was identified and treated during mitral repair with the MitraClip NT. The Micra leadless pacemaker implantation and subsequent TV repair with the MitraClip NT were successful and the patient's MR improved to mild and TR to moderate, respectively. CONCLUSIONS: We report here a first successful transcatheter strategy to treat lead-associated severe TR by leadless pacemaker and MitraClip. Removing the pacemaker lead relieved leaflet tethering and improved the reparability of the TV.

Calcium Resection to Relieve Left Main Coronary Obstruction in Transcatheter Aortic Valve Replacement.

Coronary obstruction during transcatheter aortic valve replacement (TAVR) is a rare yet life-threatening complication. Emergent resection of the obstructing calcium is a quick and simple method to restore coronary perfusion in TAVR over emergency CABG. doi: 10.1111/jocs.12752 (J Card Surg 2016;31:315-317).

Vascular complication can be minimized with a balloon-expandable, re-collapsible sheath in TAVR with a self-expanding bioprosthesis.

OBJECTIVE: This study evaluates the feasibility and safety of a balloon-expandable, re-collapsible sheath for TAVR patients, including those with small iliofemoral access (≤5.0 mm). BACKGROUND: The recommended iliofemoral diameter for the CoreValve TAVR system is ≥6.0 mm, but the lowest limit has not been determined. METHODS: Of 322 consecutive patients who underwent TAVR from 1/2014 to 8/2015 at two institutions, 64 underwent transfemoral CoreValve implantation, using an 11/19-French balloon-expandable, re-collapsible sheath, which has a 4.45 mm outer diameter (OD) on arterial entry, expands to 7.67 mm, then re-collapses upon removal. Valve sizing and vascular access were determined by computed tomography, and outcomes were assessed using the Valve Academic Research Consortium 2 (VARC-2) definitions. RESULTS: Thirteen of 64 patients had a minimal iliofemoral artery luminal diameter (MLD) of ≤5.0 mm (mean 4.38+/-0.59 mm, range 3.1-5.0 mm), with vessel calcification ≤90° to 360° and tortuosity <45° to >90°. At the MLD point, the sheath-to-artery ratios, based on the fully expanded 7.67 mm OD, ranged 1.53-2.47, higher than previously reported ratios that risk vascular complications. Major comorbidities included chronic renal failure, severe chronic obstructive pulmonary disease, extreme thrombocytopenia, cirrhosis, prior cardiac surgery, poor ventricular function, and frailty. All 64 patients had TAVR with IV sedation and local anesthesia, with 0% sheath malfunction, 0% vascular complications, and 0% bleeding in-hospital and at 30 days per VARC-2 definitions. CONCLUSIONS: TAVR using a balloon-expandable, re-collapsible sheath is safe, including in small iliofemoral access ≤5.0 mm, thus considerably expanding the population suitable for transfemoral approach. © 2015 Wiley Periodicals, Inc.