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.

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.

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.

The utility and impact of outpatient telemetry monitoring in post-transcatheter aortic valve replacement patients.

BACKGROUND: Conduction disturbances are a common complication of transcatheter aortic valve replacement (TAVR). Mobile Cardiac Telemetry (MCT) allows for continuous monitoring with near "real time" alerts and has allowed for timely detection of conduction abnormalities and pacemaker placement in small trials. A standardized, systematic approach utilizing MCT devices post TAVR has not been widely implemented, leading to variation in use across hospital systems. OBJECTIVES: Our aim was to evaluate the utility of a standardized, systematic approach utilizing routine MCT to facilitate safe and earlier discharge by identifying conduction disturbances requiring permanent pacemaker (PPM) placement. We also sought to assess the occurrence of actionable arrhythmias in post-TAVR patients. METHODS: Using guidance from the JACC Scientific Expert Panel, a protocol was implemented starting in December 2019 to guide PPM placement post-TAVR across our health system. All patients who underwent TAVR from December 2019 to June 2021 across four hospitals within Northwell Health, who did not receive or have a pre-existing PPM received an MCT device at discharge and were monitored for 30 days. Clinical and follow-up data were collected and compared to pre initiative patients. RESULTS: During the initiative 693 patients were monitored with MCT upon discharge, 21 of whom required PPM placement. Eight of these patients had no conduction abnormality on initial or discharge ECG. 59 (8.6 %) patients were found to have new atrial fibrillation or flutter via MCT monitoring. There were no adverse events in the initiative group. Prior to the initiative, 1281 patients underwent TAVR over a one-year period. The initiative group had significantly shorter length of stay than pre-initiative patients (2.5 ± 4.5 vs 3.0 ± 3.8 days, p < 0.001) and lower overall PPM placement rate within 30 days post-TAVR (16 % vs 20.5 %, P = 0.0125). CONCLUSIONS: In our study, implementation of a standardized, systematic approach utilizing MCT in post-TAVR patients was safe and allowed for timely detection of conduction abnormalities requiring pacemaker placement. This strategy also detected new atrial fibrillation and flutter. Reduction in post TAVR pacemaker rate and length of stay were also noted although this effect is multifactorial.

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.

3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.

BACKGROUND: Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process. OBJECTIVES: The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial. METHODS: Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years. RESULTS: There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; and -2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years. CONCLUSIONS: Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).

Short- and Mid-Term Outcomes of Complex and High-Risk Versus Standard Percutaneous Coronary Interventions in Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: The prevalence of coronary artery disease (CAD) in patients undergoing TAVR varies and is associated with increased morbidity and mortality. We evaluated the outcomes of complex and high-risk percutaneous coronary interventions (CHIP-PCIs) and TAVR compared with standard PCI and TAVR. Between January 2014 and March 2021, a total of 276 consecutive patients with severe aortic stenosis (AS) who underwent TAVR and PCI at 3 centers within Northwell Health were retrospectively reviewed. CHIP-PCI was defined as PCI with one of the following: left ventricular ejection fraction (LVEF) <30%; left main coronary artery (LMCA)/chronic total occlusion (CTO) intervention; atherectomy; or need for left ventricular (LV) support. One hundred twenty- seven patients (46%) had CHIP-PCI prior to TAVR and 149 patients (54%) had standard PCI. Thirteen percent of CHIP-PCI and 22% of standard PCI cases were done concomitantly with TAVR. CHIP-PCI criteria were met for low EF (19%), LMCA (25%), CTO (3%), LV support (20%), and atherectomy (50%). The types of valves used were similarly divided (49% balloon expandable vs 51% self expanding. Major adverse cardiac or cerebrovascular event (MACCE) rate for CHIP-PCI/TAVR was 4.9% at 30 days vs 1.3% for standard PCI/TAVR (P=.09), driven by in-hospital stroke. At 1 year, the rates of MACCE for CHIP-PCI/TAVR remained higher than for standard PCI/TAVR, but was not statistically significant (8.7% vs 4%; P=.06), driven by revascularization. We found no differences between major and/or minor vascular complications. New York Heart Association classification at 1 month was similar (I/II 93% vs 95%; P=.87). Our study suggests that CHIP-PCI can be safely performed in patients with complex CAD and concomitant severe AS.

Impact of age on outcomes after transcatheter aortic valve implantation.

AIMS: Usage of transcatheter aortic valve implantation (TAVI) for treatment of severe aortic stenosis is increasing across age groups. However, literature on age-specific TAVI outcomes is lacking. The purpose of this study is to assess the risks of procedural complications, mortality, and readmission in patients undergoing TAVI across different age groups. METHODS AND RESULTS: The Nationwide Readmissions Database was used to identify 84 017 patients undergoing TAVI from 2016 to 2018. Patients were stratified into four age groups: younger than 70, 70-79, 80-89, and older than 90. Complications, mortality, and readmission rates were compared between groups in a proportional hazards regression model. Risk of post-procedural stroke, acute kidney injury, and pacemaker or implantable cardioverter defibrillator implantation increased with incremental age grouping. Compared with patients younger than 70, patients aged 70-79 had no significant difference in mortality, whereas patients aged 80-89 and older than 90 had an increased mortality risk [odds ratio (OR) 1.39, confidence interval (CI) 1.14-1.70, P = 0.001 and OR 1.68, CI 1.33-2.12, P < 0.001, respectively]. Patients aged 80-89 and older than 90 had increased overall readmission compared with patients younger than 70 (HR 1.09, CI 1.03-1.14, P = 0.001 and HR 1.33, CI 1.25-1.41, P < 0.001, respectively). Cardiac readmissions followed the same trend. CONCLUSION: Patients aged 80-89 and older than 90 undergoing TAVI have increased risk of readmission, complications, and mortality compared with patients younger than 70.

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.

Comparison of clinical outcomes between use of overexpanding an undersized versus nominal-sized SAPIEN 3 ultra transcatheter heart valve in patients with borderline annulus area.

BACKGROUND: For patients with borderline annulus areas that fall between two valve sizes, overinflating a smaller balloon-expandable transcatheter heart valve (THV) may be preferable to nominal sizing of a larger THV. OBJECTIVES: To evaluate the outcomes of nominal preparation versus over-expanding an under-sized SAPIEN 3 Ultra (S3U) transcatheter heart valve (OE-THV) in cases with borderline annuli. METHODS: 958 patients that underwent TAVR with the S3U at four high-volume TAVR centers between January 2017 and December 2020 were retrospectively reviewed. 336 patients were identified as borderline annuli size, of which 146 (44%) received OE-THVs and 190 (56%) received nominal-sized THVs. The primary composite endpoint included: in-hospital mortality, aortic injury, moderate/severe paravalvular leak (PVL), permanent pacemaker implant (PPM), stroke, or conversion to surgery. RESULTS: Baseline characteristics were similar except for a larger percentage of females in the OE-THV (53.42% vs. 42.11%, p = 0.04). TAVR with OE-THV resulted a reduction in the primary composite endpoint (13.69% vs. 22.63%, p = 0.04). On subgroup analysis, there was no difference between 20 mm OE-THV versus 23 mm nominal or 23 mm OE-THV versus 26 mm nominal, but there was a reduction in the primary composite endpoint in patients with larger annuli that received a 26 mm OE-THV compared to the 29 mm nominally sized THV (9.7% vs. 27.4%, p = 0.02). At 1 month and 1 year follow-up, there was no significant difference in mortality, PVL rates, NYHA class, and/or KCCQ score. CONCLUSION: Overinflating a smaller-sized S3U THV may be a safer option in comparison to nominal sizing in patients with borderline annular area.

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.

Survival and readmission among patients with advanced cardiomyopathy undergoing transcatheter edge-to-edge mitral valve repair: Are we applying COAPT findings too broadly?

OBJECTIVE: Transcathether edge-to-edge mitral valve repair (TEER) has been shown to be an effective treatment for secondary mitral regurgitation (MR). However, the outcomes of TEER in patients with severe cardiomyopathy is less clear. The objective of this study is to determine the outcomes of such patients who underwent TEER at our institution. METHODS: A retrospective review of patients with severe cardiomyopathy, defined as ejection fraction ≤30% or the requirement of inotropic support preoperatively, undergoing TEER for secondary MR at our institution from 11/2016 to 11/2020 was performed. Univariate analysis associating preoperative characteristics with our primary endpoint of 1-year death or orthotopic heart transplant (OHT) was performed. Kaplan-Meier analysis was conducted for the composite outcome of death or OHT, as well as for heart failure-related readmission. Finally, an assessment of changes in MR severity from the preoperative, to immediate postoperative period, to 30-day postoperative period was conducted. RESULTS: There were 48 patients identified. Median age was 74.5 years (IQR 65.5-79.5), median ejection fraction was 21.5% (IQR 16.0-27.5), and 81.4% of patients had severe or torrential mitral regurgitation preoperatively. The composite endpoint of 1-year mortality or OHT occurred in 15 of 48 patients (31.3%, 14 deaths and 1 OHT). One-year heart failure readmission rate was 47.9%. Mortality or OHT at 2 years occurred in 45.8%. CONCLUSION: Patients at extremes of heart failure who underwent TEER had poor outcomes when assessed at 1-year. Our study may suggest that the results of cardiovascular outcomes assessment of the mitraclip percutaneous therapy for heart failure patients with secondary mitral regurgitation may not be applicable to patients with severe cardiomyopathy.

Balloon-Expandable Valve for Treatment of Evolut Valve Failure: Implications on Neoskirt Height and Leaflet Overhang.

OBJECTIVES: This study sought to determine the degree of Evolut (Medtronic) leaflet pinning, diameter expansion, leaflet overhang, and performance at different implant depths of the balloon-expandable Sapien 3 (S3, Edwards Lifesciences LLC) transcatheter heart valve (THV) within the Evolut THV. BACKGROUND: Preservation of coronary access and flow is a major factor when considering the treatment of failed Evolut THVs. METHODS: An in vitro study was performed with 20-, 23-, 26-, and 29-mm S3 THVs deployed within 23-, 26-, 29-, and 34-mm Evolut R THVs, respectively. The S3 outflow was positioned at various depths at node 4, 5, and 6 of the Evolut R. Neoskirt height, leaflet overhang, performance, and Evolut R valve housing diameter expansion were assessed under physiological conditions as per ISO 5840-3 standard. RESULTS: The neoskirt height for the Evolut R was shorter when the S3 outflow was positioned at node 4 compared with node 6 (node 4 height for 23 mm = 16.3 mm, 26 mm = 17.1 mm, 29 mm = 18.3 mm, and 34 mm = 19.9 mm vs node 6 height for 23 mm = 23.9 mm, 26 mm = 23.4 mm, 29 mm = 24.7 mm, and 34 mm = 27 mm Evolut R). All configurations exhibited acceptable hydrodynamic performance irrespective of the degree of leaflet overhang, except the 29-mm S3 implanted in 34-mm Evolut R at node 4 (regurgitant fraction >20%). The valve housing radius of the index Evolut R increased when the S3 was implanted, with the increase ranging from 0 to 2.5 mm. CONCLUSIONS: Placement of the S3 at a lower implant position within an index Evolut R reduces the neoskirt height with no significant compromise to S3 valve function despite a higher degree of leaflet overhang. Low S3 implantation may facilitate future coronary access after redo transcatheter aortic valve replacement.

Association between multimodality measures of aortic stenosis severity and quality-of-life improvement outcomes after transcatheter aortic valve replacement.

AIMS: Up to 40% of patients with aortic stenosis (AS) present with discordant grading of AS severity based on common transthoracic echocardiography (TTE) measures. Our aim was to evaluate the utility of TTE and multi-detector computed tomography (MDCT) measures in predicting symptomatic improvement in patients with AS undergoing transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: A retrospective review of 201 TAVR patients from January 2017 to November 2018 was performed. Pre- and post-intervention quality-of-life was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Pre-intervention measures including dimensionless index (DI), stroke volume index (SVI), mean transaortic gradient, peak transaortic velocity, indexed aortic valve area (AVA), aortic valve calcium score, and AVA based on hybrid MDCT-Doppler calculations were obtained and correlated with change in KCCQ-12 at 30-day follow-up. Among the 201 patients studied, median KCCQ-12 improved from 54.2 pre-intervention to 85.9 post-intervention. In multivariable analysis, patients with a mean gradient >40 mmHg experienced significantly greater improvement in KCCQ-12 at follow-up than those with mean gradient ≤40 mmHg (28.1 vs. 16.4, P = 0.015). Patients with MDCT-Doppler-calculated AVA of ≤1.2 cm2 had greater improvements in KCCQ-12 scores than those with computed tomography-measured AVA of >1.2 cm2 (23.4 vs. 14.1, P = 0.049) on univariate but not multivariable analysis. No association was detected between DI, SVI, peak velocity, calcium score, or AVA index and change in KCCQ-12. CONCLUSION: Mean transaortic gradient is predictive of improvement in quality-of-life after TAVR. This measure of AS severity may warrant greater relative consideration when selecting the appropriateness of patients for TAVR.

Racial and socioeconomic disparities in urgent transcatheter mitral valve repair: A National Inpatient Sample analysis.

BACKGROUND: Cardiac interventions performed urgently are known to be associated with poor outcomes compared with electively performed procedures. Transcatheter edge-to-edge mitral valve repair (TMVr) has developed as a reasonable alternative to mitral valve surgery in certain patient populations. We aimed to leverage a national database to identify predictors of urgent versus elective TMVr, as well as the association between urgency and outcomes. METHODS: The National Inpatient Sample (NIS) was queried to identify patients who underwent TMVr from 2016 to 2017. Hospitalizations were identified within the database as elective versus nonelective. Univariate and multivariable analyses were performed to identify patient characteristics associated with urgent procedures. In-hospital outcomes were assessed. RESULTS: There were 10,195 cases of TMVr in this cohort, 24.2% of which were performed urgently. In multivariable analysis, Hispanic race, Medicaid insurance, and low income were associated with increased likelihood of urgent hospital admission and TMVr. Additionally, small hospital size and Northeast region were associated with increased likelihood of urgent admission and procedure. Urgent TMVr was associated with increased mortality (4.5% vs. 1.6%, p < .001), prolonged length of stay (6.0 vs. 2.0, p < .001), and increased cost ($71,451.90 vs. $44,981.20, p < .001). CONCLUSIONS: Racial and socioeconomic disparities exist in the utilization of TMVr as an urgent versus elective procedure, suggesting differences in access to surveillance and preventive care. Urgent TMVr is associated with increased morbidity and mortality, prolonged length of stay, and increased hospital costs. Priority should be placed on mitigating such disparities to improve outcomes.

Impact of chronic lung disease on quality-of-life outcomes in patients undergoing transcatheter aortic valve replacement.

BACKGROUND: As the symptoms for both chronic lung disease (CLD) and aortic stenosis (AS) frequently overlap, it may be challenging to determine the degree of symptomatic improvement expected for a patient with CLD after correction of AS. Our aim was to determine if patients with CLD have the same degree of quality-of-life improvement following transcatheter aortic valve replacement (TAVR) as patients without CLD. METHODS: A retrospective review of 238 TAVR patients from January 2017 to November 2018 who underwent preoperative pulmonary function tests and completed 30-day follow-up was performed. Patients were identified as having CLD with FEV1 more than 75% predicted. Postoperative outcomes and changes in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) were compared between groups. RESULTS: Of the 238 patients identified, 143 (60.0%) had CLD, 50 (35.0%) of whom had an obstructive disease pattern. Patients with CLD were more likely to be male, had higher rates of peripheral artery disease, and had lower baseline ejection fraction. There was no difference in STS Predicted Risk of Mortality, but patients with CLD were more likely to be designated as high-risk by surgeon evaluation. While initial and follow-up KCCQ-12 was lower for patients with CLD, there was no significant difference in degree of improvement (p = .900). When comparing patients with obstructive lung disease (FEV1/FVC < 0.70) to those without CLD, there was also no significant difference in the change of quality of life (p = .720). CONCLUSION: Although patients with concomitant severe AS and CLD have reduced baseline quality of life compared to patients without CLD, they experience a comparable degree of improvement following TAVR.

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.