Using novel machine learning tools to predict optimal discharge following transcatheter aortic valve replacement.

BACKGROUND: Although transcatheter aortic valve replacement has emerged as an alternative to surgical aortic valve replacement, it requires extensive healthcare resources, and optimal length of hospital stay has become increasingly important. This study was conducted to assess the potential of novel machine learning models (artificial neural network and eXtreme Gradient Boost) in predicting optimal hospital discharge following transcatheter aortic valve replacement. AIM: To determine whether artificial neural network and eXtreme Gradient Boost models can be used to accurately predict optimal discharge following transcatheter aortic valve replacement. METHODS: Data were collected from the 2016-2018 National Inpatient Sample database using International Classification of Diseases, Tenth Revision codes. Patients were divided into two cohorts based on length of hospital stay: optimal discharge (length of hospital stay 0-3 days); and late discharge (length of hospital stay 4-9 days). χ2 and t tests were performed to compare patient characteristics with optimal discharge and prolonged discharge. Logistic regression, artificial neural network and eXtreme Gradient Boost models were used to predict optimal discharge. Model performance was determined using area under the curve and F1 score. An area under the curve≥0.80 and an F1 score≥0.70 were considered strong predictive accuracy. RESULTS: Twenty-five thousand and eight hundred and seventy-four patients who underwent transcatheter aortic valve replacement were analysed. Predictability of optimal discharge was similar amongst the models (area under the curve 0.80 in all models). In all models, patient disposition and elective procedure were the most important predictive factors. Coagulation disorder was the strongest co-morbidity predictor of whether a patient had an optimal discharge. CONCLUSIONS: Artificial neural network and eXtreme Gradient Boost models had satisfactory performances, demonstrating similar accuracy to binary logistic regression in predicting optimal discharge following transcatheter aortic valve replacement. Further validation and refinement of these models may lead to broader clinical adoption.

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.

Transcatheter tricuspid valve intervention in the presence of a cardiac implantable electronic device; state of the art review.

A large proportion of patients referred for transcatheter tricuspid valve intervention (TTVI) will have the presence of a cardiac implantable electronic device (CIED). In such patients, surgical correction of tricuspid regurgitation (TR) is associated with high rates of morbidity and mortality. Transvenous lead extraction (TLE) could potentially ameliorate CIED-induced TR; however, it carries inherent risks and frequently does not result in TR improvement. As multiple TTVI devices are in trial to gain regulatory approval, understanding which therapy is most appropriate among patients with a CIED is essential. This review centers on the nonsurgical treatment, including TLE and transcatheter tricuspid valve repair and replacement options, aimed at enhancing outcomes in patients with TR who also have concurrent CIEDs.

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.

Multiple Valvular Heart Disease in the Transcatheter Era: A State-of-the-Art Review.

Although existing guidelines offer strong recommendations for single valvular dysfunction, the growing prevalence of multiple valvular heart disease (MVHD) in our aging population is challenging the clarity of clinical guidance. Traditional diagnostic modalities, such as echocardiography, face inherent constraints in precisely quantifying valvular dysfunction due to the hemodynamic interactions that occur with multiple valve involvement. Therefore, many patients with MVHD present at a later stage in their disease course and with an elevated surgical risk. The expansion of transcatheter therapy for the treatment of valvular heart disease has added new opportunities for higher-risk patients. However, the impact of isolated valve therapies on patients with MVHD is still not well understood. This review focuses on the etiology, diagnostic challenges, and therapeutic considerations for some of the most common concomitant valvular abnormalities that occur in our daily clinic population.

Snare technique to facilitate 'tall-in-short' redo-TAVR.

An 82-year-old man with a prior history of transcatheter aortic valve replacement (TAVR) with a 23-mm balloon-expandable transcatheter heart valve (THV) presented with bioprosthetic stenosis.

Balloon rupture during transcatheter aortic valve replacement.

A distinctive complication with balloon-expandable (BE) THV platforms such as the Edwards Sapien (Edwards Lifescience) is the possibility of balloon rupture during THV deployment. Balloon rupture is a rare occurrence that can result in stroke due to fragment embolism, incomplete THV expansion, and/or vascular injury upon retrieval of the balloon. Careful evaluation of preoperative computed tomography is essential to identify high-risk cases. While annular and left ventricular outflow tract (LVOT) calcification are widely acknowledged as common risks for balloon injury, it's essential to note that balloon injury can manifest at various anatomical sites. In this review, we discuss the mechanism behind balloon rupture, methods to identify cases at a heightened risk of balloon injury, approaches to mitigate the risk of rupture, and percutaneous retrieval strategies.

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.

Fusion Imaging Guidance for Coronary Reaccess After Valve-in-Valve Transcatheter Aortic Valve Replacement.

Coronary reaccess can be difficult after valve-in-valve transcatheter aortic valve replacement. We present a case whereby prior valve-in-valve transcatheter aortic valve replacement created difficulty with coronary reaccess. Computed tomography-fluoroscopy fusion imaging was used for guidance to successfully engage the coronary arteries and perform percutaneous coronary intervention.

Role of Cerebral Embolic Protection Devices in Patients Undergoing Transcatheter Aortic Valve Replacement: An Updated Meta-Analysis.

BACKGROUND: Cerebral embolic protection devices (CEPD) capture embolic material in an attempt to reduce ischemic brain injury during transcatheter aortic valve replacement. Prior reports have indicated mixed results regarding the benefits of these devices. With new data emerging, we performed an updated meta-analysis examining the effect of CEPD during transcatheter aortic valve replacement on various clinical, neurological, and safety parameters. METHODS AND RESULTS: A comprehensive review of electronic databases was performed comparing CEPD and no-CEPD in transcatheter aortic valve replacement. Primary clinical outcome was all-cause stroke. Secondary clinical outcomes were disabling stroke and all-cause mortality. Neurological outcomes included worsening of the National Institutes of Health Stroke Scale score, Montreal Cognitive Assessment score from baseline at discharge, presence of new ischemic lesions, and total lesion volume on neuroimaging. Safety outcomes included major or minor vascular complications and stage 2 or 3 acute kidney injury. Seven randomized controlled trials with 4016 patients met the inclusion criteria. There was no statistically significant difference in the primary clinical outcome of all-cause stroke; secondary clinical outcomes of disabling stroke, all-cause mortality, neurological outcomes of National Institutes of Health Stroke Scale score worsening, Montreal Cognitive Assessment worsening, presence of new ischemic lesions, or total lesion volume on diffusion-weighted magnetic resonance imaging between CEPD versus control groups. There was no statistically significant difference in major or minor vascular complications or stage 2 or 3 acute kidney injury between the groups. CONCLUSIONS: The use of CEPD in transcatheter aortic valve replacement was not associated with a statistically significant reduction in the risk of clinical, neurological, and safety outcomes.

Kissing balloon inflation for transcatheter aortic valve replacement and abutting ostial coronary artery stent.

In patients with ostial coronary stents protruding into the aorta, there is concern for stent injury while undergoing transcatheter aortic valve replacement (TAVR) with balloon-expandable transcatheter heart valve (THV). An 82-year-old male with history of symptomatic aortic stenosis, heart failure, and coronary artery disease with multiple interventions to right coronary artery (RCA) and a history of stent fracture requiring stent-in-stent placement one year previously, was evaluated for TAVR. His ostial RCA stent was protruding into the aorta at the level of sinotubular junction, with ostial stent to aortic wall (SAW) distance of 25.2 mm. There was concern for balloon inflation during TAVR leading to stent injury. The RCA was cannulated with a 6 French JR4 guide and wired with 0.014' coronary wire. Appropriately sized noncompliant balloon was advanced into RCA. Under rapid pacing, the coronary balloon was inflated across the RCA ostium followed by simultaneous deployment of THV. Intravascular imaging of the ostial RCA stent revealed no stent fracture. SAW distance is important to determine the possibility of balloon-induced stent injury during valve deployment. In cases where an ostial stent may interact with balloon inflation, kissing-balloon inflation may be performed to prevent stent injury. Learning objective: In patients with ostial coronary stents protruding into the aorta, stent to aortic wall distance is important to determine the possibility of balloon-induced stent injury during balloon-expandable transcatheter heart valve deployment. Kissing-balloon inflation may be performed to prevent stent injury.

Chargemaster Pricing Variation for Commonly Billed Procedures in Interventional Cardiology.

OBJECTIVES: A chargemaster is a database of all of the billable items offered by a hospital with their base price listings. A 2018 executive order required all American hospitals to publish their chargemasters to increase price transparency and reduce healthcare expenditures. Chargemaster listings, however, demonstrate marked variability and inconsistency and have not been associated with consumer benefit. The objective of this study was to analyze chargemasters for commonly billed interventional cardiology procedures across five diverse states to explore relationships between price listings and hospital characteristics, ownership, location, and hospital quality. METHODS: Chargemasters were downloaded from hospitals in five states selected to represent the nation's healthcare diversity. Price listings for five interventional cardiology procedures (percutaneous coronary angiography, coronary angiography, single-vessel angioplasty, single-vessel stent, and percutaneous coronary intervention of acute myocardial infarction) were extracted. Statistical analyses such as the Kruskal-Wallis test were performed to explore relationships between mean chargemaster price listings for each procedure and hospital characteristics, ownership, location, and quality ratings. RESULTS: The median mean chargemaster price of four of the five interventional cardiology procedures significantly differed across all states. Price listings were significantly higher in urban versus rural areas and in general acute care hospitals and state government-owned facilities. The highest prices were found with the highest hospital quality rating. CONCLUSIONS: Chargemaster price listings for common interventional cardiology procedures varied significantly across these five states. Urban and metropolitan hospital location, hospital type, and hospital ownership could be factors driving increased chargemaster procedure prices. Prices were highest at hospitals with the highest quality rating.

Comparison of Periprocedural and Intermediate-Term Outcomes of TAVI in Patients with Ejection Fraction ≤ 20% vs. Patients with 20% < EF ≤ 40.

Treatment of congestive heart failure (CHF) with left ventricular (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. We compared the periprocedural outcomes of TAVR in patients with an ejection fraction (EF) of ≤20% (VLEF group) to patients with an EF > 20% to ≤40% (LEF group). We included patients with severe AS and reduced LV ejection fraction (LVEF ≤ 40%) who underwent TAVR at four centers within Northwell Health between January 2016 and December 2020. Over 2000 consecutive patients were analyzed, of which 355 patients met the inclusion criteria. The primary composite endpoint was in-hospital mortality, moderate or greater paravalvular (PVL), stroke, conversion to open surgery, aortic valve re-intervention, and/or need for PPM. Secondary endpoints were length of stay, NYHA classification at 1 month and 1 year, mortality at 1 month and 1 year, mean valve gradient at 1 month, KCCQ score at 1 month, and ≥ moderate PVL at 1 month. There was no difference in the primary composite endpoint between the two groups (23.6% for VLEF vs. 25.3% for LEF, p = 0.29). During TAVR placement, 40% of patients in the VLEF group required ≥1 vasopressors for hypotension lasting ≥30 min vs. only 21% of patients in the LEF group (p < 0.01). Intra-aortic balloon pump (IABP) use during procedure was greater in the VLEF group (9% vs. 1%, p < 0.01)-all placed post TAVR. Emergency ECMO use was higher in the VLEF group as well (5% vs. 0%). Total length of stay was significantly different between the two groups as well (6 days vs. 3 days, p < 0.01). Both groups had a change in LVEF of ~10%. One-year outcomes were similar between the groups. All-cause mortality at 1 year was not significantly different at 1 year (13% for VLEF vs. 11% for LEF), and KCC scores were also similar (77.54 vs. 74.97). Mean aortic valve gradients were also similar (12 mmHg vs. 11 mmHg, p = 0.48). Our study suggests that patients with EF ≤ 20% can safely have TAVR with similar periprocedural outcomes compared to patients with EF > 20% to ≤40% despite higher rates of vasopressor and mechanical support.

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.

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.

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.