Collagen-Based Bailout Compared to Suture-Mediated Vascular Closure Alone During Transcatheter Aortic Valve Replacement.

Background: Hemostasis for transfemoral transcatheter aortic valve replacement (TAVR) is typically achieved using a suture-mediated vascular closure device (VCD) prior to large-bore sheath insertion (preclosure technique). Recently, the addition of a hybrid closure technique using a preclose technique with the addition of a collagen-plug VCD after sheath removal in cases of failed hemostasis has been utilized. Methods: Data were collected from the Northwell TAVR registry, including 3 high-volume TAVR centers. We evaluated a preclose strategy with suture-mediated vascular closure alone ("legacy strategy") and standard bailout techniques versus a contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout. The primary end point was major or minor vascular complications as defined by the VARC-3 criteria. Results: A total of 1327 patients were included, of which 791 patients underwent TAVR with suture-mediated closure alone and 536 with contemporary strategy. The primary end point (major or minor vascular complication) was lower in the contemporary strategy (5.44% vs 1.31%; P < .001). Both minor (3.92% vs 1.12%; P = .002) and major (1.14% vs 0.19%; P = .0196) vascular complications were reduced and the total length of stay was less in the contemporary strategy (median of 3 days vs 2 days; P < .0001). Using multivariable analysis, we observed that vascular management strategy significantly improved the composite primary outcome when adjusted for sheath size, peripheral artery disease, carotid disease, and site of procedure. In the contemporary group, bailout collagen-plug VCD with an Angio-Seal (Terumo Medical) was used in 68 patients (12.69%) and bailout MANTA (Teleflex) was required in 4 patients (0.75%). There were no major or minor vascular complications among the patients who received bailout collagen-plug VCD. Conclusions: A contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout reduces the risk of vascular complications among patients undergoing transfemoral TAVR.

IntraCardiac echocardiography-guided leaflet modification for coronary protection prior to transcatheter valve-in-valve replacement.

A 79-year-old man with a failed 25-mm CE Magna Ease 3300 surgical prosthesis (Edwards Lifesciences) and of high re-operative surgical risk (STS 8%) presented with dyspnea, NYHA III. Cardiac computed tomography angiography revealed anatomy that was high risk for coronary occlusion with a short right coronary artery height of 6 mm and a valve-to-coronary distance of 2 mm.

Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.

BACKGROUND: The CLASP IID randomized trial (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial) demonstrated the safety and effectiveness of the PASCAL system for mitral transcatheter edge-to-edge repair (M-TEER) in patients at prohibitive surgical risk with significant symptomatic degenerative mitral regurgitation (DMR). OBJECTIVES: This study describes the echocardiographic methods and outcomes from the CLASP IID trial and analyzes baseline variables associated with residual mitral regurgitation (MR) ≤1+. METHODS: An independent echocardiographic core laboratory assessed echocardiographic parameters based on American Society of Echocardiography guidelines focusing on MR mechanism, severity, and feasibility of M-TEER. Factors associated with residual MR ≤1+ were identified using logistic regression. RESULTS: In 180 randomized patients, baseline echocardiographic parameters were well matched between the PASCAL (n = 117) and MitraClip (n = 63) groups, with flail leaflets present in 79.2% of patients. Baseline MR was 4+ in 76.4% and 3+ in 23.6% of patients. All patients achieved MR ≤2+ at discharge. The proportion of patients with MR ≤1+ was similar in both groups at discharge but diverged at 6 months, favoring PASCAL (83.7% vs 71.2%). Overall, patients with a smaller flail gap were significantly more likely to achieve MR ≤1+ at discharge (adjusted OR: 0.70; 95% CI: 0.50-0.99). Patients treated with PASCAL and those with a smaller flail gap were significantly more likely to sustain MR ≤1+ to 6 months (adjusted OR: 2.72 and 0.76; 95% CI: 1.08-6.89 and 0.60-0.98, respectively). CONCLUSIONS: The study used DMR-specific echocardiographic methodology for M-TEER reflecting current guidelines and advances in 3-dimensional echocardiography. Treatment with PASCAL and a smaller flail gap were significant factors in sustaining MR ≤1+ to 6 months. Results demonstrate that MR ≤1+ is an achievable benchmark for successful M-TEER. (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID]; NCT03706833).

Utility of Multidetector Computed Tomographic Angiography as an Alternative to Transesophageal Echocardiogram for Preoperative Transcatheter Mitral Valve Repair Planning.

BACKGROUND: Three-dimensional (3D) transesophageal echocardiogram (TEE) is the gold standard for the diagnosis of degenerative mitral regurgitation (dMR) and preoperative planning for transcatheter mitral valve repair (TMVr). TEE is an invasive modality requiring anesthesia and esophageal intubation. The severe acute respiratory syndrome coronavirus 2 pandemic has limited the number of elective invasive procedures. Multi-detector computed tomographic angiography (MDCT) provides high-resolution images and 3D reconstructions to assess complex mitral anatomy. We hypothesized that MDCT would reveal similar information to TEE relevant to TMVr, thus deferring the need for a preoperative TEE in certain situations like during a pandemic. METHODS: We retrospectively analyzed data on patients who underwent or were evaluated for TMVr for dMR with preoperative MDCT and TEE between 2017 and 2019. Two TEE and 2 MDCT readers, blinded to patient outcome, analyzed: leaflet pathology (flail, degenerative, mixed), leaflet location, mitral valve area (MVA), flail width/gap, anterior-posterior (AP) and commissural diameters, posterior leaflet length, leaflet thickness, presence of mitral valve cleft and degree of mitral annular calcification (MAC). RESULTS: A total of 22 (out of 87) patients had preoperative MDCT. MDCT correctly identified the leaflet pathology in 77% (17/22), flail leaflet in 91% (10/11), MAC degree in 91% (10/11) and the dysfunctional leaflet location in 95% (21/22) of patients. There were no differences in the measurements for MVA, flail width, commissural or AP diameter, posterior leaflet length, and leaflet thickness. MDCT overestimated the measurements of flail gap. CONCLUSIONS: For preoperative TMVr planning, MDCT provided similar measurements to TEE in our study.

Predictors of Residual Severe Tricuspid Regurgitation After Transcatheter Mitral Valve Repair.

Background: Severe tricuspid regurgitation (TR) may persist after a mitral transcatheter edge-to-edge repair (M-TEER) and is associated with worsened clinical outcomes and survival. It is unclear which patients with concomitant mitral regurgitation (MR) and TR will have TR reduction after M-TEER. The aim of this study was to identify the predictors of residual TR after transcatheter edge-to-edge repair (TEER). Methods: Data were collected from the Northwell TEER registry, a prospectively maintained mandatory database including 4 high-volume transcatheter aortic valve replacement/TEER centers. Transthoracic echocardiograms, both pre-TEER and post-TEER, were evaluated. Univariate and multivariate logistic regression analyses were performed to identify predictors of severe TR after M-TEER. Significant TR reduction was defined as a reduction in TR grade by at least 1+ with moderate (2+) or less TR at 1 month. Results: Of the 479 patients who underwent M-TEER, 107 patients with concomitant severe MR/TR were included. Successful MR reduction occurred in 89 patients (84%) and a significant TR reduction in 45 (42%). On the univariate analysis, the only predictors of severe residual TR were right atrial area and unsuccessful M-TEER. On the multivariate logistic regression model, the only predictor variable for patients with a reduction in TR was MR reduction of ≥3+ with M-TEER. Conclusions: In patients with concomitant severe MR and TR, TR reduction after isolated M-TEER occurs in only ∼40% of patients. MR grade reduction ≥3+ was the only independent predictor for TR reduction. Other clinical and echocardiographic variables (including pulmonary hypertension, right ventricular function, tricuspid annular dilation, atrial fibrillation, and presence of a cardiac implantable electrical device) were not associated with residual TR. Inability to predict TR reduction after M-TEER highlights the importance of establishing transcatheter tricuspid valve therapies and should factor in heart-team discussions.

A Novel Computed Tomographic Angiography Tortuosity Index to Predict Successful Sentinel Cerebral Embolic Protection Delivery for Transcatheter Aortic Valve Replacement.

Background: Percutaneous transradial placement of the Sentinel cerebral embolic protection device (CEPD) (Boston Scientific) is indicated during transcatheter aortic valve replacement to capture embolic material in patients without excessive tortuosity of the right subclavian/innominate arteries. We aimed to generate a quantitative tortuosity index (TI) from the preoperative computed tomographic angiography (CTA) as an objective measure of tortuosity to determine suitability for CEPD placement. Methods: Eighty-one patients considered for CEPD were included in this study. A centerline of the right subclavian/innominate arteries was generated from preoperative CTA scans. Three-dimensional Cartesian coordinates of landmarks along the centerline were used to calculate curvature. Tortuosity was derived as a change in angulation along each vessel segment. Peak and average TI values were calculated. Results: Sixty-seven patients had CEPD placement attempted. Unsuccessful CEPD placement occurred in 3 of 67 (4.4%) patients. The peak tortuosity for the successful, unsuccessful, and visually tortuous (not attempted) cohorts were 49.66 ± 11.96°/cm, 113.92 ± 5.70°/cm, and 70.44 ± 17.01°/cm, respectively. The peak and average TI of the successful cohort follows a normal distribution. A proposed TI cutoff for safe CEPD was peak tortuosity of 74°/cm and average tortuosity of 30°/cm, 2 standard deviations above the peak and average TI of the successful cohort. All unsuccessful CEPD patients fell outside the boundaries. Half of the visually tortuous patients were within the boundaries but did not have CEPD attempted. Conclusions: A novel TI based on preoperative CTA can assist in selecting patients for transradial CEPD. Our proposed quantitative tool may help to appropriately include and exclude patients for CEPD placement.

Preventability of 30-day readmissions for heart failure patients before and after a quality improvement initiative.

The objective of this study was to estimate the frequency of heart failure (HF) readmissions that can be prevented through a quality improvement (QI) program. All HF patients at the University of Connecticut Health Center who had a readmission within 30 days of discharge in the year before (2008) and the year after (2011) a QI program were studied. Through chart review, the percentage of patients who had preventable readmissions in each year was estimated. Prior to the QI initiative, chart reviewers identified that 20% to 30% of readmissions were preventable. The decrease in readmissions after the QI program was similar at 28%. Fewer readmissions after the QI initiative were deemed preventable compared with before. In conclusion, this study found a percentage of preventable readmissions similar to the actual 28% reduction in readmissions after a QI program was launched. Preventable readmissions were less common after the QI program was in place.