Contemporary experience of mitral transcatheter edge-to-edge repair technology in patients with mitral annular calcification.

BACKGROUND: Mitral annular calcification (MAC) has been an exclusion for many of the earlier pivotal trials that were instrumental in gaining device approval and indications for mitral transcatheter edge-to-edge repair (M-TEER). AIMS: To evaluate the impact of MAC on the procedural durability and success of newer generation MitraClip® systems (G3 and G4 systems). METHODS: Data were collected from Northwell TEER registry. Patients that underwent M-TEER with third or fourth generation MitraClip device were included. Patients were divided into -MAC (none-mild) and +MAC (moderate-severe) groups. Procedural success was defined as ≤ grade 2 + mitral regurgitation (MR) postprocedure, and durability was defined as ≤ grade 2 + MR retention at 1 month and 1 year. Univariate analysis compared outcomes between groups. RESULTS: Of 260 M-TEER patients, 160 were -MAC and 100 were +MAC. Procedural success was comparable; however, there were three patients who required conversion to cardiac surgery during the index hospitalization in the +MAC group versus none in the -MAC group (though this was not statistically significant). At 1-month follow-up, there were no significant differences in MR severity. At 1-year follow-up, +MAC had higher moderate-severe MR (22.1% vs. 7.5%; p = 0.002) and higher mean transmitral gradients (5.3 vs. 4.0 mmHg; p = 0.001) with no differences in mortality, New York Heart Association functional class or ejection fraction. CONCLUSION: In selective patients with high burden of MAC, contemporary M-TEER is safe, and procedural success is similar to patients with none-mild MAC. However, a loss of procedural durability was seen in +MAC group at 1-year follow-up. Further studies with longer follow-ups are required to assess newer mTEER devices and their potential clinical implications in patients with a high burden of MAC.

Lead management in patients undergoing percutaneous tricuspid valve replacement or repair: a 'heart team' approach.

Clinically significant tricuspid regurgitation (TR) has historically been managed with either medical therapy or surgical interventions. More recently, percutaneous trans-catheter tricuspid valve (TV) replacement and tricuspid trans-catheter edge-to-edge repair have emerged as alternative treatment modalities. Patients with cardiac implantable electronic devices (CIEDs) have an increased incidence of TR. Severe TR in this population can occur for multiple reasons but most often results from the interactions between the CIED lead and the TV apparatus. Management decisions in patients with CIED leads and clinically significant TR, who are undergoing evaluation for a percutaneous TV intervention, need careful consideration as a trans-venous lead extraction (TLE) may both worsen and improve TR severity. Furthermore, given the potential risks of 'jailing' a CIED lead at the time of a percutaneous TV intervention (lead fracture and risk of subsequent infections), consideration should be given to performing a TLE prior to a percutaneous TV intervention. The purpose of this 'state-of-the-art' review is to provide an overview of the causes of TR in patients with CIEDs, discuss the available therapeutic options for patients with TR and CIED leads, and advocate for including a lead management specialist as a member of the 'heart team' when making treatment decisions in patients TR and CIED leads.

Transcatheter heart valve selection in patients with low ejection fraction and aortic stenosis.

OBJECTIVE: The aim of this study was to compare outcomes of transcatheter heart valve (THV) choice in patients with left ventricular (LV) systolic dysfunction. BACKGROUND: The management congestive heart failure with combined LV systolic dysfunction and severe aortic stenosis (AS) is challenging, yet transcatheter aortic valve replacement (TAVR) has emerged as a suitable treatment option in such patients. Head-to-head comparisons among the balloon-expandable (BEV) and self-expandable (SEV) THV remain limited in this subgroup of patients. METHODS: In this retrospective study, we included patients with severe AS with LV systolic dysfunction (LVEF ≤40%) who underwent TAVR at four high volume centers. Two thousand and twenty-eight consecutive patients were analyzed, of which 335 patients met inclusion criteria. One hundred fourty-six patients (43%) received a SEV, and 189 patients (57%) received a BEV. RESULTS: Baseline characteristics were similar except for a higher proportion of females in the SEV group. The primary composite endpoint of in-hospital mortality, moderate or greater paravalvular (PVL), stroke, conversion to open surgery, aortic valve reintervention, and/or need for permanent pacemaker (PPM) was no different among THV choice. There was more PVL in the SEV group, but higher transaortic gradients in the BEV group. Clinical outcomes and quality of life measures were similar up to 1 year follow-up. CONCLUSION: The choice of THV in patients with severe AS and systolic dysfunction must be weighed on a case-by-case basis.

Accuracy of predicted effective orifice area in determining incidence of patient-prosthesis mismatch after transcatheter aortic valve replacement.

OBJECTIVE: Patient-prosthesis mismatch (PPM) is associated with poor outcomes after aortic valve replacement. The aim of this study was to assess the accuracy of indexed effective orifice area (EOAi) charts in predicting PPM after transcatheter aortic valve replacement (TAVR). METHODS: A retrospective review of 346 TAVR patients from January 2017 to November 2018 was performed. EOAi was predicted for patients based on published predictive tables using valve type, annulus diameter, and body surface area. Actual EOAi was calculated based on intraoperative transesophageal echocardiogram (TEE) measurements. PPM was defined by EOAi ≤ 0.85 cm2 /m2 . The accuracy of predicted PPM was assessed. Differences in clinical outcomes, including mean gradient, length of stay, mortality, complications, and change in Kansas City cardiomyopathy questionnaire score as an indicator of quality of life, were evaluated based on actual PPM. RESULTS: Of the 346 patients analyzed, 44 (12.7%) of patients had PPM on intraoperative TEE. Of the 182 patients who received Sapien 3 valves, 42 (23.1%) were predicted to have PPM while 25 (13.7%) had actual PPM. Of the 164 patients who received Evolut valves, 3 (1.8%) were predicted to have PPM while 19 (11.6%) had actual PPM. EOAi charts had poor sensitivity (40.0% for Sapien 3; 5.25% for Evolut) and positive predictive value (23.8% for Sapien 3; 33.3% for Evolut) for both valve types. CONCLUSION: Preoperative prediction of PPM in TAVR patients using tables of expected EOA demonstrates significant variation from actual PPM. The utility of EOAi charts to predict PPM in patients undergoing TAVR may be limited.

Evaluating the Validity of Risk Scoring in Predicting Pacemaker Rates following Transcatheter Aortic Valve Replacement.

INTRODUCTION: Requirement of permanent pacemaker (PPM) implantation is a known and common postoperative consequence of transcatheter aortic valve replacement (TAVR). The Emory risk score has been recently developed to help risk stratify the need for PPM insertion in patients undergoing TAVR with SAPIEN 3 valves. Our aim was to assess the validity of this risk score in our patient population, as well as its applicability to patients receiving self-expanding valves. METHODS: We conducted a retrospective review of 479 TAVR patients without preoperative pacemakers from November 2016 through December 2018. Preoperative risk factors included in the Emory risk score were collected for each patient: preoperative QRS, preoperative right bundle branch block (RBBB), preoperative syncope, and degree of valve oversizing. Multivariable analysis of the individual variables within the scoring system to identify predictors of PPM placement was performed. The predictive discrimination of the risk score for the risk of PPM placement after TAVR was assessed with the area under the receiver operating characteristic curve (AUC). RESULTS: Our results demonstrated that, of the 479 patients analyzed, 236 (49.3%) received balloon-expandable valves and 243 (50.7%) received self-expanding valves. Pacemaker rates were higher in patients receiving self-expanding valves than those receiving balloon-expandable valves (25.1% versus 16.1%, p=0.018). The Emory risk score showed a moderate correlation with pacemaker requirement in patients receiving each valve type, with AUC for balloon-expandable and self-expanding valves of 0.657 and 0.645, respectively. Of the four risk score components, preoperative RBBB was the only predictor of pacemaker requirement with an AUC of 0.615 for both balloon-expandable and self-expanding valves. Conclusion. In our cohort, the Emory risk score had modest predictive utility for PPM insertion after balloon-expandable and self-expanding TAVR. The risk score did not offer better discriminatory utility than that of preoperative RBBB alone. Understanding the determinants of PPM insertion after TAVR can better guide patient education and postoperative management.

CTA Detection of Left Atrial Stasis and Thrombus in Patients with Atrial Fibrillation.

BACKGROUND: We investigated computed tomography (CT) angiography (CTA) in assessment of left atrial appendage (LAA) stasis and thrombus in preprocedural evaluation for atrial fibrillation (AF) ablation in a large community cohort. METHODS AND RESULTS: We reviewed CTA and transesophageal echocardiographic images obtained in 861 consecutive patients with a history of AF undergoing same-day CTA and transesophageal echocardiogram (TEE) before AF ablation at a single hospital (2006-2013). CTA findings of LAA filling defects from acquisitions without electrocardiogram gating were compared to TEE features of LAA stasis (grade 0-4) and thrombus. Stasis grade 0 or 1 by TEE in the absence of thrombus was defined as a negative result. In addition, LAA peak flow velocity was assessed by TEE. Average age was 61 ± 10 years and 75% were male. On CTA, 161 patients (19%) had LAA filling defects on CTA and 21 had ≥grade 2 stasis on TEE, including two with thrombus, resulting in a positive predictive value of only 13%. However, among 670 CTA-negative patients, 669 (99%) were negative for thrombus or stasis by TEE with one false-negative CTA in a patient with grade 2 stasis by TEE but no thrombus, yielding a negative predictive value of 99.9%. Slow LAA Doppler flow velocity was the most important determinant of false-positive CTA results in multivariate analysis (P < 0.0001) CONCLUSION: LAA filling defects on CT are associated with slow LAA flow velocity. AF patients without LAA filing defects on CT are free of significant stasis and thrombus on TEE. It may be possible to eliminate TEE in up to 80% of AF ablation patients based on negative CTA findings.

Cardiac Myosin Inhibition for Treatment of LVOT Obstruction in a Patient With Severe AS.

Aortic stenosis and obstructive hypertrophic cardiomyopathy are common conditions. When both are present in the same patient, the management can be challenging. We report what we believe to be the first time a cardiac myosin inhibitor has been used before transcutaneous aortic valve replacement.

Transcatheter Mitral Valve Repair for Multiple Valvular Heart Disease: Outcomes and Insights on Combined Aortic Insufficiency and Mitral Regurgitation.

The presence of concomitant aortic insufficiency (AI) and mitral regurgitation (MR) is common and may further accelerate cardiac dysfunction. However, there exists no US regulatory-approved transcatheter device for the treatment of AI. The effectiveness of isolated transcatheter mitral therapy in this population is not well-understood; thus, we aimed to evaluate outcomes for patients with combined AI and MR compared with isolated MR who underwent mitral transcatheter edge-to-edge repair (m-TEER). Retrospective data were obtained from the Northwell m-TEER registry. A total of 587 patients who underwent m-TEER at 4 high-volume transcatheter aortic valve replacement/transcatheter edge-to-edge repair centers within the Northwell Health system were included. All patients had severe MR and were divided into 2 groups: group 1 with ≥3+ AI (AI+) and the group 2 with <3+ AI (AI-). Echocardiographic outcomes were evaluated at 1 month. Clinical outcomes were evaluated at 1 month and 1 year. The primary end point was death or rehospitalization at 1 year. A total of 587 patients were included in the study, with 92 in the AI+ group. Baseline characteristics were similar in both groups. Approximately 2/3 of patients in the AI+ group demonstrated an improvement in AI severity after isolated mitral therapy. There was no difference in the primary outcome at 1 month or 1 year. There was also no significant difference in New York Heart Association functional class at 1 month between the groups. In conclusion, patients who underwent m-TEER with combined MR and AI (AI+ group) fared well compared with those with isolated mitral valve dysfunction (AI- group), with no discernible differences in survival, New York Heart Association class, or rehospitalization rates at 1 month or 1 year. Hence, isolated m-TEER is a reasonable treatment approach in patients with a high surgical risk with combined AI and MR.

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.

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).

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.

The Half-Century Mark: Explant of Ball and Cage Valve after 50 Years.

This is a case report of a 69-year-old man with chronic hemolysis and worsening diastolic heart failure, secondary to known periprosthetic leak, who underwent a reoperative mitral valve replacement 50 years following initial implantation of a Starr-Edwards ball and cage valve.

Paucicellular Fibroma of the Ascending Aorta.

Primary tumors of the aorta are extremely rare. To the best of our knowledge, herein, we present the first case in the literature of a paucicellular fibroma originating from the aortic wall.

Predicting paravalvular regurgitation following transcatheter valve replacement: utility of a novel method for three-dimensional echocardiographic measurements of the aortic annulus.

BACKGROUND: Studies evaluating three-dimensional echocardiographic (3DE) annular sizing for balloon-expandable transcatheter aortic valve replacement (TAVR) are limited. In this study, a retrospective analysis of transesophageal echocardiographic images was performed to assess the feasibility of multiplanar measurements of annular dimensions by the novel off-label use of commercially available 3DE software and correlate annular sizing with severity of paravalvular regurgitation (PVR). METHODS: Intraprocedural transesophageal echocardiography was performed in 58 patients undergoing TAVR for severe, symptomatic aortic stenosis. Off-label use of commercially available software was used to measure transesophageal 3DE volumes. Pre-TAVR annular linear dimensions included two-dimensional echocardiographic sagittal diameter and 3DE measurements of minimal diameter, maximal diameter (MaxDiam), and the average or mean diameter. Three-dimensional echocardiographic average annular diameter derived from annular perimeter (AveAnnDiamP) and average annular diameter derived from annular area (AveAnnDiamA) were calculated. A cover index was calculated using each measurement. Short-axis PVR color jet areas were summed after deployment and at the end of study. RESULTS: Two-dimensional echocardiographic sagittal diameter was significantly smaller than 3DE MaxDiam (P < .0001) and AveAnnDiamP (P = .017), significantly larger than 3DE minimal diameter (P < .0001), and not significantly different from 3DE mean diameter (P = .36) and AveAnnDiamA (P = .38). There was a linear relationship between all 3DE annular measurements and immediate post-TAVR PVR area (P ≤ .0001), with the largest R(2) value (0.48) for 3DE MaxDiam, 3DE AveAnnDiamP, and 3DE AveAnnDiamA. The largest areas under the curve to detect greater than mild PVR were for 3DE AveAnnDiamP cover index (0.772) and 3DE AveAnnDiamA cover index (0.769). Intraclass correlation coefficients for interobserver and intraobserver variability were high for 3DE AveAnnDiamP and 3DE AveAnnDiamA and lower for 3DE MaxDiam. CONCLUSIONS: Using a novel approach to 3DE annular measurements, 3DE AveAnnDiamP and 3DE AveAnnDiamA can be reliably measured and correlate best with post-TAVR PVR area. New sizing algorithms with 3DE measurements should be developed.

Efficacy and safety of postdilatation to reduce paravalvular regurgitation during balloon-expandable transcatheter aortic valve replacement.

BACKGROUND: Paravalvular regurgitation (PVR) is common after transcatheter aortic valve replacement (TAVR) and may be associated with adverse outcomes. Postdilatation (PD) has been proposed to treat PVR without being formally studied. We performed a study to evaluate the safety and efficacy of PD after balloon expandable TAVR. METHODS AND RESULTS: Consecutive cases of TAVR were reviewed for clinical outcomes. Procedural transesophageal echocardiography imaging was reviewed for a subgroup of consecutive patients. PVR areas seen on a short-axis view were measured immediately after deployment, after PD, and at the completion of the study. Stent dimensions measured using angiography and the Paieon's C-THV system pre- and post-PD were compared. Between May 2007 and November 2011, 259 patients underwent TAVR at our institution. PD was performed in 106 patients (41%). These patients had larger annulus, lower cover-index; more often had transfemoral access and implantation of a 26 mm valve. There was a nonsignificant greater rate of cerebrovascular events in PD patients. There was no significant difference in major aortic injury and permanent pacemaker implantation rates between groups. TTE studies were reviewed in 58 patients (35 with PD and 23 without PD). PD patients had larger PVR areas immediately after deployment (40.3±17.1 versus 15.4±14.2 mm(2); P<0.0001). There was significant reduction in PVR area attributable to PD (21.7±9.3 mm(2); P<0.0001). Spontaneous regression of PVR was seen in both groups. PD increased stent dimensions. CONCLUSIONS: This study demonstrates the efficacy of PD at reducing PVR in patients with greater than mild PVR after balloon-expandable TAVR.

Effect of physician volume on the relationship between hospital volume and mortality during primary angioplasty.

OBJECTIVES: We sought to examine the combined effect of hospital and physician volume of primary percutaneous coronary intervention (PCI) on in-hospital mortality. BACKGROUND: An inverse relationship between volume and outcome has been observed for both hospitals and physicians after primary PCI for acute myocardial infarction. METHODS: Using the New York State PCI registry, we examined yearly hospital volume, physician volume, and risk-adjusted mortality in 7,321 patients undergoing primary PCI for acute myocardial infarction. Risk-adjusted mortality rates for high-volume hospitals (>50 cases/year) and high-volume physicians (>10 cases/year) were compared with their respective low-volume counterparts. RESULTS: Primary PCI by high-volume hospitals (odds ratio [OR]: 0.58; 95% confidence interval [CI]: 0.38 to 0.88) and high-volume physicians (OR: 0.66; 95% CI: 0.48 to 0.92) was associated with lower odds of mortality. Furthermore, there was a significant interaction between hospital and physician volume on adjusted mortality (p = 0.02). Although unadjusted mortality was lower when primary PCI was performed by high-volume physicians in high-volume hospitals compared with low-volume physicians in low-volume hospitals (3.2% vs. 6.7%, p = 0.03), the risk-adjusted mortality rate was not statistically significant (3.8% vs. 8.4%, p = 0.09). In low-volume hospitals, the average risk-adjusted mortality rate for low-volume physicians was 8.4% versus 4.8% for high-volume physicians (OR: 1.44; 95% CI: 0.68 to 3.03). However, in high-volume hospitals, the risk-adjusted mortality rate for high-volume physicians was 3.8% versus 6.5% for low-volume physicians (OR: 0.58; 95% CI: 0.39 to 0.86). CONCLUSIONS: During primary PCI, physician experience significantly modifies the hospital volume-outcome relationship. Therefore, policymakers need to consider physician experience when developing strategies to improve access to primary PCI.