Outcomes and treatment strategy of transcatheter aortic valve replacement with balloon-expandable valve in borderline-size annulus.

BACKGROUND: Candidates for transcatheter aortic valve replacement (TAVR) occasionally have a "borderline-size" aortic annulus between 2 transcatheter heart valve sizes, based on the manufacturer's sizing chart. Data on TAVR outcomes in such patients are limited. METHODS: We retrospectively reviewed 1816 patients who underwent transfemoral-TAVR with balloon-expandable valve (BEV) at our institution between 2016 and 2020. We divided patients into borderline and non-borderline groups based on computed tomography-derived annular measurements and compared outcomes. Furthermore, we analyzed procedural characteristics and compared outcomes between the smaller- and larger-valve strategies in patients with borderline-size annulus. RESULTS: During a median follow-up of 23.3 months, there was no significant difference between the borderline (n = 310, 17.0 %) and non-borderline (n = 1506) groups in mortality (17.3 % vs. 19.5 %; hazard ratio [HR] = 0.86 [95% CI = 0.62-1.20], p = 0.39), major adverse cardiac/cerebrovascular events (MACCE: death/myocardial infarction/stroke, 21.2 % vs. 21.5 %; HR = 0.97 [0.71-1.32], p = 0.85), paravalvular leak (PVL: mild 21.8 % vs. 20.6 %, p = 0.81; moderate 0 % vs. 1.2 %; p = 0.37), or mean gradient (12.9 ± 5.8 vs. 12.6 ± 5.2 mmHg, p = 0.69) at 1 year. There was no significant difference between the larger-(n = 113) and smaller-valve(n = 197) subgroups in mortality (23.7 % vs. 15.2 %; HR = 1.57 [0.89-2.77], p = 0.12), MACCE (28.1 % vs. 18.4 %; HR = 1.52 [0.91-2.54], p = 0.11), mild PVL (13.3 % vs. 25.9 %; p = 0.12), or mean gradient (12.3 ± 4.5 vs. 13.6 ± 5.3 mmHg, p = 0.16); however, the rate of permanent pacemaker implantation (PPI) was higher in the larger-valve subgroup (15.9 % vs. 2.6 %, p < 0.001). CONCLUSION: Borderline-size annulus is not associated with higher risk of adverse outcomes after BEV-TAVR. However, the larger-valve strategy for borderline-size annulus is associated with higher PPI risk, suggesting a greater risk of injury to the conduction system.

Mitral Valve Repair of the Anterior Leaflet: Are We There Yet?

Mitral regurgitation is one of the most prevalent valvulopathies with a disease burden that incurs significant healthcare costs globally. Surgical repair of the posterior mitral valve leaflet is a standard treatment, but approaches for repairing the anterior mitral valve leaflet are not widely established. Since anterior leaflet involvement is less common and more difficult to repair, fewer studies have investigated its natural history and treatment options. In this review, we discuss surgical techniques for repairing the anterior leaflet and their outcomes, including survival, reoperation, and recurrence of regurgitation. We show that most patients with mitral regurgitation from the anterior leaflet can be repaired with good outcomes if performed at centers with expertise. Additionally, equal consideration for early repair should be given to patients with mitral regurgitation from both anterior and posterior pathology. However, more studies to better evaluate the efficacy and safety of anterior mitral valve leaflet repair are needed.

Impact of untreated chronic obstructive coronary artery disease on outcomes after transcatheter aortic valve replacement.

BACKGROUND AND AIMS: In transcatheter aortic valve replacement (TAVR) recipients, the optimal management of concomitant chronic obstructive coronary artery disease (CAD) remains unknown. Some advocate for pre-TAVR percutaneous coronary intervention, while others manage it expectantly. The aim of this study was to assess the impact of varying degrees and extent of untreated chronic obstructive CAD on TAVR and longer-term outcomes. METHODS: The authors conducted a retrospective cohort study of TAVR recipients from January 2015 to November 2021, separating patients into stable non-obstructive or varying degrees of obstructive CAD. The major outcomes of interest were procedural all-cause mortality and complications, major adverse cardiovascular events, and post-TAVR unplanned coronary revascularization. RESULTS: Of the 1911 patients meeting inclusion, 75%, 6%, 10%, and 9% had non-obstructive, intermediate-risk, high-risk, and extreme-risk CAD, respectively. Procedural complication rates overall were low (death 0.4%, shock 0.1%, extracorporeal membrane oxygenation 0.1%), with no difference across groups. At a median follow-up of 21 months, rates of acute coronary syndrome and unplanned coronary revascularization were 0.7% and 0.5%, respectively, in the non-obstructive population, rising in incidence with increasing severity of CAD (P < .001 for acute coronary syndrome/unplanned coronary revascularization). Multivariable analysis did not yield a significantly greater risk of all-cause mortality or major adverse cardiovascular events across groups. One-year acute coronary syndrome and unplanned coronary revascularization rates in time-to-event analyses were significantly greater in the non-obstructive (98%) vs. obstructive (94%) subsets (Plog-rank< .001). CONCLUSIONS: Transcatheter aortic valve replacement can be performed safely in patients with untreated chronic obstructive CAD, without portending higher procedural complication rates and with relatively low rates of unplanned coronary revascularization and acute coronary syndrome at 1 year.

Contrast-Sparing Intravascular Ultrasound-Guided Caval Valve Implantation for Severe Symptomatic Tricuspid Regurgitation.

Patients with severe tricuspid regurgitation and right ventricular dysfunction have limited therapeutic options due to anatomic complexity, advanced disease at presentation, and comorbidities. Caval valve implantation is an emerging transcatheter therapy. We present a case series of contrast-sparing caval valve implantation using intravascular ultrasound guidance in patients with renal failure. (Level of Difficulty: Advanced.).

A novel method of prosthetic leaflet modification to enable transcatheter mitral valve-in-valve replacement.

Left ventricular outflow tract (LVOT) obstruction from the displaced prosthetic anterior mitral leaflet is a life-threatening complication that can occur during valve-in-valve (ViV) transcatheter mitral valve replacement (TMVR). Laceration of the anterior mitral leaflet to prevent outflow obstruction is a well-established transcatheter technique to mitigate the risk of LVOT obstruction in high-risk anatomies. In this report, we present a novel transseptal technique of prosthetic leaflet modification to prevent LVOT obstruction during ViV TMVR.

Effectiveness of Pre-TAVR CTA as a Screening Tool for Significant CAD Before TAVR.

BACKGROUND: Computed tomography angiography (CTA) and invasive coronary angiography (ICA) are routinely performed before transcatheter aortic valve replacement (TAVR) to assess aortic root anatomy and screen for coronary artery disease (CAD), respectively. OBJECTIVES: This study explored the efficacy of CTA as a screening tool for significant proximal CAD before TAVR. METHODS: With proper ethical oversight, patients undergoing TAVR at Cleveland Clinic with a preprocedural CTA and invasive coronary angiography (ICA), and no prior percutaneous intervention, were identified from 2015 to 2021. Blinded to ICA results, the authors reviewed the left main, proximal left anterior descending coronary artery, proximal left circumflex coronary artery, and proximal right coronary artery by CTA coronary reconstruction to assess for nonsignificant stenosis (0% to 49%), moderate stenosis (50% to 69%), and severe stenosis (≥70%). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and Cohen Kappa statistic were analyzed. RESULTS: 2,217 patients (53.4% male, age 79.2 ± 8.5 years) met inclusion criteria. CTA evaluation revealed a sensitivity of 90%, specificity of 92%, PPV of 74%, and NPV of 97% for detecting ≥50% stenosis. Using a ≥70% stenosis cutoff, evaluation revealed a sensitivity of 91%, specificity of 97%, PPV of 83%, and NPV of 99%. Assessment of bypass graft patency revealed a sensitivity of 86%, specificity of 97%, PPV of 84%, and NPV of 98%. Cohen Kappa analysis indicated substantial to near perfect agreement between pre-TAVR CTA and ICA. CONCLUSIONS: Pre-TAVR CTA has a high NPV for high-grade proximal stenosis of each coronary artery. As a result, CTA can be used as a screening tool to rule out significant proximal CAD in patients undergoing TAVR.

Comparison of Outcomes Following Transcatheter Aortic Valve Replacement Requiring Peripheral Vascular Intervention or Alternative Access.

Background Peripheral vascular intervention (PVI) is occasionally required to facilitate delivery system insertion or to treat vascular complications during transfemoral transcatheter aortic valve replacement (TF-TAVR). However, the impact of PVI on outcomes is not well understood. Therefore, we aimed to compare outcomes between TF-TAVR with versus without PVI and between TF-TAVR with PVI versus non-TF-TAVR. Methods and Results We retrospectively reviewed 2386 patients who underwent TAVR with a balloon-expandable valve at a single institution from 2016 to 2020. The primary outcomes were death and major adverse cardiac/cerebrovascular event (MACCE), defined as death, myocardial infarction, or stroke. Of 2246 TF-TAVR recipients, 136 (6.1%) required PVI (89% bailout treatment). During follow-up (median 23.0 months), there were no significant differences between TF-TAVR with and without PVI in death (15.4% versus 20.7%; adjusted HR [aHR], 0.96 [95% CI, 0.58-1.58]) or MACCE (16.9% versus 23.0%; aHR, 0.84 [95% CI, 0.52-1.36]). However, compared with non-TF-TAVR (n=140), TF-TAVR with PVI carried significantly lower rates of death (15.4% versus 40.7%; aHR, 0.42 [95% CI, 0.24-0.75]) and MACCE (16.9% versus 45.0%; aHR, 0.40 [95% CI, 0.23-0.68]). Landmark analyses demonstrated lower outcome rates following TF-TAVR with PVI than non-TF-TAVR both within 60 days (death 0.7% versus 5.7%, P=0.019; MACCE 0.7% versus 9.3%; P=0.001) and thereafter (death 15.0% versus 38.9%, P=0.014; MACCE 16.5% versus 41.3%, P=0.013). Conclusions The need for PVI during TF-TAVR is not uncommon, mainly due to the bailout treatment for vascular complications. PVI is not associated with worse outcomes in TF-TAVR recipients. Even when PVI is required, TF-TAVR is associated with better short- and intermediate-term outcomes than non-TF-TAVR.

Transcatheter left ventriculoplasty.

Despite significant advances in pharmacological, electrophysiological and valve therapies for heart failure with reduced ejection fraction (HFrEF), the associated morbidity, mortality and healthcare costs remain high. With a constantly growing heart failure population, the existing treatment gap between current and advanced heart failure therapies (e.g., left ventricular [LV] assist devices, heart transplantation) reflects a large unmet need, calling for novel therapeutic approaches. Left ventricular remodelling and dilatation, with or without scar formation, is the hallmark of cardiomyopathy and is associated with poor prognosis. In the era of exciting advances in structural heart interventions, the advent of minimally invasive, device-based therapies directly targeting the LV geometry and promoting physical reverse remodelling has created a new frontier in the battle against heart failure. Interventional heart failure therapy is a rapidly emerging field, encompassing structural heart and minimally invasive hybrid procedures, with two left ventriculoplasty devices currently under investigation in pivotal clinical trials in the US. This review addresses the rationale for left ventriculoplasty, presents the prior surgical and percutaneous attempts in the field, provides an overview of the novel transcatheter left ventriculoplasty devices and their respective trials, and highlights potential challenges associated with establishing such device-based therapies in our armamentarium against heart failure.

Three-Year Outcomes of Balloon-Expandable Transcatheter Aortic Valve Implantation According to Annular Size.

Data on the association between annular size and transcatheter aortic valve implantation (TAVI) outcomes beyond 1 year are limited. The present study assessed the association between the aortic annulus size and TAVI clinical and hemodynamic outcomes at 3 years of follow-up. Patients were classified according to the aortic annulus size as having small, intermediate, and large annuli (size <400, 400 to 574, and ≥575 mm2, respectively). The co-primary endpoints were all-cause mortality and heart failure hospitalization. Further, the changes in hemodynamic outcomes over the follow-up period (median 37, interquartile range: 26 to 45 months) were assessed. The present analysis included 850 patients, with 182 patients (21.4%), 538 patients (63.3%), and 130 patients (15.3%) in the small, intermediate, and large-sized aortic annulus groups, respectively. The groups had comparable age and pre-TAVI pressure gradients; however, patients with small annuli had higher Society of Thoracic Surgeons risk scores. Adjusted Cox regression analysis showed that compared to patients with intermediate-sized annuli, patients with small and large annuli had similar all-cause mortality (hazard ratio [HR] = 1.11, 95% confidence interval [CI] 0.72 to 1.69 and HR = 0.74, 95% CI 0.48 to 1.16, respectively) and heart failure hospitalization rates (HR = 0.96, 95% CI 0.55 to 1.69 and HR = 1.26, 95% CI 0.73 to 2.17, respectively). However, patients with small annuli had consistently higher mean and peak pressure gradients and a higher risk of patient-prosthesis mismatch. The risks of moderate-to-severe regurgitation and structural valve deterioration were similar between the three groups. In conclusion, although patients with small annuli had higher transvalvular gradients, there was no significant association between the aortic annulus size and TAVI clinical outcomes at 3 years of follow-up. Future studies should compare the performance of transcatheter valve types in patients with different aortic annulus sizes.

One-year clinical and echocardiographic outcomes of transcatheter aortic valve replacement with SAPIEN 3 Ultra versus SAPIEN 3.

BACKGROUND: The newest-generation balloon-expandable valve, SAPIEN 3 Ultra (S3U), is expected to function well with the enhanced sealing skirt compared with SAPIEN 3 (S3). However, current literature on the comparison between these two valves is limited to short-term follow-ups. Therefore, we aimed to evaluate the 1-year outcomes and echocardiographic changes of S3U compared with S3. METHODS: We retrospectively identified patients who underwent transfemoral-transcatheter aortic valve replacement with S3U or S3 (20/23/26 mm) at our institution in 2018-2020. Outcomes were 1-year clinical events and echocardiographic parameters, and were compared between S3U and S3 after adjustment with inverse probability of treatment weighting. RESULTS: The S3U and S3 groups included 297 (25.7%) and 858 (74.3%) patients, respectively. There were no significant differences between the two groups in clinical events (death 5.8% vs. 5.5%, hazard ratio [HR] 1.07, 95% confidence interval [CI] 0.81-1.90; death or heart failure hospitalization 10.3% vs. 10.1%, HR 1.04, 95% CI 0.67-1.62). The S3U group had a lower prevalence of mild paravalvular leakage (PVL) (13.7% vs. 22.3%, p = 0.044), with similar moderate PVL (0.7% vs. 1.2%, p > 0.99). No significant differences were observed in aortic valve mean gradient and Doppler velocity index at 1 year. However, the S3U group had a larger increase in mean gradient from implantation to 1 year (median +4.70 vs. +1.63 mmHg, p < 0.001). CONCLUSIONS: S3U and S3 carried similarly favorable clinical event risks. Nonetheless, S3U was associated with less frequent mild PVL but a larger increase in transprosthetic gradient. Further studies are needed to determine the prognostic impact of these hemodynamic differences.

Cerebral embolic protection and severity of stroke following transcatheter aortic valve replacement.

BACKGROUND: The cerebral embolic protection (CEP) device captures embolic debris during transcatheter aortic valve replacement (TAVR). However, the impact of CEP on stroke severity following TAVR remains unclear. Therefore, we aimed to examine whether CEP was associated with reduced severity of stroke following TAVR. METHODS: This was a retrospective cohort study of 2839 consecutive patients (mean age: 79.2 ± 9.5 years, females: 41.5%) who underwent transfemoral TAVR at our institution between 2013 and 2020. We categorized patients into Sentinel CEP users and nonusers. Neuroimaging data were reviewed and the final diagnosis of a cerebrovascular event was adjudicated by a neurologist blinded to the CEP use or nonuse. We compared the incidence and severity (assessed by the National Institutes of Health Stroke Scale [NIHSS]) of stroke through 72 h post-TAVR or discharge between the two groups using stabilized inverse probability of treatment weighting (IPTW) of propensity scores. RESULTS: Of the eligible patients, 1802 (63.5%) received CEP during TAVR and 1037 (36.5%) did not. After adjustment for patient characteristics by stabilized IPTW, the rate of overall stroke was numerically lower in CEP users than in CEP nonusers, but the difference did not reach statistical significance (0.49% vs. 1.18%, p = 0.064). However, CEP users had significantly lower rates of moderate-or-severe stroke (NIHSS ≥ 6: 0.11% vs. 0.69%, p = 0.013) and severe stroke (NIHSS ≥ 15: 0% vs. 0.29%, p = 0.046). Stroke following CEP use (n = 8), compared with stroke following CEP nonuse (n = 15), tended to carry a lower NIHSS (median [IQR], 4.0 [2.0-7.0] vs. 7.0 [4.5-19.0], p = 0.087). Four (26.7%) out of 15 patients with stroke following CEP nonuse died within 30 days, with no death after stroke following CEP use. CONCLUSIONS: CEP use may be associated with attenuated severity of stroke despite no significant difference in overall stroke incidence compared with CEP nonuse. This finding is considered hypothesis-generating and needs to be confirmed in large prospective studies.

Novel devices for managing heart failure.

PURPOSE OF REVIEW: Despite advances in heart failure (HF) therapies, the associated morbidity, mortality, hospitalization rates, and healthcare expenditures remain high. A significant proportion of patients with HF remain symptomatic despite receiving optimal medical therapy. Consequently, there exists a large unmet clinical need for novel therapies for treating acute and chronic HF. With the exponential growth of transcatheter interventions in structural heart disease, novel applications of minimally invasive, device-based therapies have been sought in an effort to bridge this treatment gap. The rationale, development, and current data underscoring these therapies will be summarized in this review. RECENT FINDINGS: Recent studies have demonstrated the safety and efficacy of devices that alter left ventricular geometry (i.e., ventriculoplasty), create anatomic shunts to decompress the left atrium, and modulate vena caval and renal blood flow. However pivotal large trials evaluating clinical outcomes are ongoing. SUMMARY: Innovative device-based therapies may expand our armamentarium against the growing heterogeneous and morbid HF syndrome.

Left Ventricular Systolic Dysfunction in Aortic Stenosis: Pathophysiology, Diagnosis, Management, and Future Directions.

Degenerative calcific aortic stenosis (AS) is the most common valvular heart disease and often co-exists with left ventricular (LV) systolic dysfunction at the time of diagnosis. Impaired LV systolic function has been associated with worse outcomes in the setting of AS, even after successful aortic valve replacement (AVR). Myocyte apoptosis and myocardial fibrosis are the 2 key mechanisms responsible for the transition from the initial adaptation phase of LV hypertrophy to the phase of heart failure with reduced ejection fraction. Novel advanced imaging methods, based on echocardiography and cardiac magnetic resonance imaging, can detect LV dysfunction and remodeling at an early and reversible stage, with important implications for the optimal timing of AVR especially in patients with asymptomatic severe AS. Furthermore, the advent of transcatheter AVR as a first-line treatment for AS with excellent procedural outcomes, and evidence that even moderate AS portends worse prognosis in heart failure with reduced ejection fraction patients, has raised the question of early valve intervention in this patient population. With this review, we describe the pathophysiology and outcomes of LV systolic dysfunction in the setting of AS, present imaging predictors of LV recovery after AVR, and discuss future directions in the treatment of AS extending beyond the traditional indications defined in the current guidelines.

Very late vasomotor responses and gene expression with bioresorbable scaffolds and metallic drug-eluting stents.

OBJECTIVES: To investigate the long-term vasomotor response and inflammatory changes in Absorb bioresorbable vascular scaffold (BVS) and metallic drug-eluting stent (DES) implanted artery. BACKGROUND: Clinical evidence has demonstrated that compared to DES, BVS is associated with higher rates of target lesion failure. However, it is not known whether the higher event rates observed with BVS are related to endothelial dysfunction or inflammation associated with polymer degradation. METHODS: Ten Absorb BVS and six Xience V DES were randomly implanted in the main coronaries of six nonatherosclerotic swine. At 4-years, vasomotor response was evaluated in vivo by quantitative coronary angiography response to intracoronary infusion of Ach and ex vivo by the biomechanical response to prostaglandin F2-α (PGF2-α), substance P and bradykinin and gene expression analysis. RESULTS: Absorb BVS implanted arteries showed significantly restored vasoconstrictive responses after Ach compared to in-stent Xience V. The contractility of Absorb BVS treated segments induced by PGF2-α was significantly greater compared to Xience V treated segments and endothelial-dependent vasorelaxation was greater with Absorb BVS compared to Xience V. Gene expression analyses indicated the pro-inflammatory lymphotoxin-beta receptor (LTßR) signaling pathway was significantly upregulated in arteries treated with a metallic stent compared to Absorb BVS treated arterial segments. CONCLUSIONS: At 4 years, arteries treated with Absorb BVS compared with Xience V, demonstrate significantly greater restoration of vasomotor responses. Genetic analysis suggests mechanobiologic reparation of Absorb BVS treated arteries at 4 years as opposed to Xience V treated vessels.

The role of ISCHEMIA in stable ischemic heart disease.

Although it is well established that adding early revascularization to optimal medical therapy reduces mortality and recurrent myocardial infarction in acute coronary syndrome, there is less convincing evidence to guide intervention in stable ischemic heart disease. This review summarizes the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial, which investigated whether there is benefit from initial catheterization and possible revascularization in addition to optimal medical therapy in patients with at least moderate ischemia on stress testing.

Surgical Repair for Primary Tricuspid Valve Disease: Individualized Surgical Planning With 3-Dimensional Printing.

Primary tricuspid valve (TV) disease is rare and associated with high operative mortality. Optimal surgical planning requires a precise understanding of the pathological features; however, detailed imaging of the TV can be challenging. We present 4 cases of primary TV disease where 3-dimensional printing was pivotal to operative planning and success. (Level of Difficulty: Advanced.).

Percutaneous Retrieval of a Watchman Device from the Left Ventricle Using a Transarterial Approach.

Left atrial appendage closure device embolization is a rare yet serious complication. The location of the embolized device is a major determinant of the retrieval approach, percutaneous or surgical. This paper presents the case of Watchman device embolization in the left ventricle, which was retrieved percutaneously by using a transarterial approach. (Level of Difficulty: Intermediate.).