Clinical characteristics and outcomes of alcohol septal ablation in the era of transcatheter valve interventions.

BACKGROUND: The clinical efficacy and safety of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) have been well-established; however, less is known about outcomes in patients undergoing preemptive ASA before transcatheter mitral valve replacement (TMVR). AIMS: The goal of this study is to characterize the procedural characteristics and examine the clinical outcomes of ASA in both HCM and pre-TMVR. METHODS: This retrospective study compared procedural characteristics and outcomes in patient who underwent ASA for HCM and TMVR. RESULTS: In total, 137 patients were included, 86 in the HCM group and 51 in the TMVR group. The intraventricular septal thickness (mean 1.8 vs. 1.2 cm; p < 0.0001) and the pre-ASA LVOT gradient (73.6 vs. 33.8 mmHg; p ≤ 0.001) were higher in the HCM group vs the TMVR group. The mean volume of ethanol injected was higher (mean 2.4 vs. 1.7 cc; p < 0.0001). The average neo-left ventricular outflow tract area increased significantly after ASA in the patients undergoing TMVR (99.2 ± 83.37 mm2 vs. 196.5 ± 114.55 mm2; p = <0.0001). The HCM group had a greater reduction in the LVOT gradient after ASA vs the TMVR group (49.3 vs. 18 mmHg; p = 0.0040). The primary composite endpoint was higher in the TMVR group versus the HCM group (50.9% vs. 25.6%; p = 0.0404) and had a higher incidence of new permanent pacemaker (PPM) (25.5% vs. 18.6%; p = 0.3402). The TMVR group had a higher rate of all-cause mortality (9.8% vs. 1.2%; p = 0.0268). CONCLUSIONS: Preemptive ASA before TMVR was performed in patients with higher degree of clinical comorbidities, and correspondingly is associated with worse short-term clinical outcomes in comparison to ASA for HCM patients. ASA before TMVR enabled percutaneous mitral interventions in a small but significant minority of patients that would have otherwise been excluded. The degree of LVOT and neoLVOT area increase is significant and predictable.

Feasibility and technicality of aortic valve lithotripsy-facilitate balloon valvuloplasty in patients with severe aortic stenosis unsuitable for immediate valvular replacement.

BACKGROUND: Aortic valve lithotripsy can fragment aortic valve calcium deposits and potentially restore leaflet pliability in animal model and ex-vivo, but clinical data is limited. Transcatheter aortic valve implantation (TAVR) might not be feasible as an urgent procedure in critically ill patients. Balloon valvuloplasty has the major limitation of valve recoil and inducing aortic regurgitation. AIMS: To determine the clinical feasibility of aortic valve lithotripsy-facilitated balloon valvuloplasty in patients with severe aortic stenosis unsuitable for valvular replacement. METHODS: We performed lithotripsy as adjunctive therapy to balloon aortic valvuloplasty in ten consecutive patients, most of whom were deemed unfit for TAVR. Lithotripsy of the aortic valve was performed with simultaneous inflation of one to three peripheral lithotripsy balloons to deliver ultrasound pulses. Rapid pacing was not used during lithotripsy. Aortic valve velocity, gradient, and valve area were measured before and after the procedure by echocardiogram. Transvalvular pressure gradient was recorded intra-procedurally. Periprocedural and ninety-day clinical outcomes were followed. RESULTS: Procedure was technically successful in 9 out of 10 patients and aborted in one patient due to cardiogenic shock. One patient had femoral closure device related complication. There was a statistically significant decrease in valvular gradient and increase in aortic valve area. 9 out of 10 patients recovered from acute episode and were discharged. 6 patients had improvement in NYHA class. 4 patients were subsequently able to receive TAVR. 90-day mortality occurred in 3 patients. There was no stroke or bradyarrhythmia peri-procedurally and no heart failure hospitalization at 90 days. CONCLUSION: Aortic valve lithotripsy-facilitated balloon valvuloplasty has reasonable feasibility, safety and technical reproducibility and acute clinical result. Hemodynamic effect is similar to that of balloon valvuloplasty reported in the literature. Subsequent Prognosis is not altered in critically ill patients.

Contemporary experience of percutaneous management of complex aortic and ventricular pseudoaneurysms associated to perivalvular leak: A case series and review of literature.

BACKGROUND: Percutaneous closure of aortic and ventricular pseudoaneurysms (PSA) has only been reported on a case report and series basis. In previous case reports, percutaneous closure has been performed successfully in patients of prohibitive surgical risk. This case series aims to show feasibility of percutaneous closure of aortic and ventricular pseudoaneurysm secondary to perivalvular leak (PVL) in a small patient population and the utility of multimodality imaging as an integral tool in procedural planning. This is the largest complex case series to date describing the feasibility and success rate of complex PSA closure, with a follow-up period of up to 4 years. MATERIAL AND METHODS: We performed institutional review and systemic literature review to identify all paravalvular leak cases with associated pseudoaneurysm formation for which a closure procedure was performed. Ten patients were identified. Pooled analysis for cases from institutional review (n = 10) and systemic literature review (n = 39) was performed. The success rate was 100 %. At 30-days, the mortality was 0 %. CONCLUSION: In paravalvular leak patients with subsequent pseudoaneurysm formation, exhaustive imaging evaluation is required for closure. However, it can be achievable with favorable rates of success.

Impact of the COVID-19 Pandemic on Global TAVR Activity: The COVID-TAVI Study.

BACKGROUND: The COVID-19 pandemic adversely affected health care systems. Patients in need of transcatheter aortic valve replacement (TAVR) are especially susceptible to treatment delays. OBJECTIVES: This study sought to evaluate the impact of the COVID-19 pandemic on global TAVR activity. METHODS: This international registry reported monthly TAVR case volume in participating institutions prior to and during the COVID-19 pandemic (January 2018 to December 2021). Hospital-level information on public vs private, urban vs rural, and TAVR volume was collected, as was country-level information on socioeconomic status, COVID-19 incidence, and governmental public health responses. RESULTS: We included 130 centers from 61 countries, including 65,980 TAVR procedures. The first and second pandemic waves were associated with a significant reduction of 15% (P < 0.001) and 7% (P < 0.001) in monthly TAVR case volume, respectively, compared with the prepandemic period. The third pandemic wave was not associated with reduced TAVR activity. A greater reduction in TAVR activity was observed in Africa (-52%; P = 0.001), Central-South America (-33%; P < 0.001), and Asia (-29%; P < 0.001). Private hospitals (P = 0.005), urban areas (P = 0.011), low-volume centers (P = 0.002), countries with lower development (P < 0.001) and economic status (P < 0.001), higher COVID-19 incidence (P < 0.001), and more stringent public health restrictions (P < 0.001) experienced a greater reduction in TAVR activity. CONCLUSIONS: TAVR procedural volume declined substantially during the first and second waves of the COVID-19 pandemic, especially in Africa, Central-South America, and Asia. National socioeconomic status, COVID-19 incidence, and public health responses were associated with treatment delays. This information should inform public health policy in case of future global health crises.

3D print and multi-modality imaging guided transcatheter closure of multiple left ventricular pseudoaneurysms.

Left ventricular pseudoaneurysm (PSA) after surgical aortic valve replacement (AVR) is a known but uncommon complication. It is associated with risks such as thromboembolism and life-threatening rupture. Surgical repair has traditionally been utilized in low-risk patients but transcatheter closure has become a promising therapeutic option. This case report describes the utility of multimodality imaging in pre-, intra-, and post-procedural evaluation of transcatheter PSA closure and is among the first to demonstrate the utility of 3D print model.

Unplanned readmissions after Impella mechanical circulatory support.

BACKGROUND: Early readmissions significantly impact on patient-wellbeing, burden the health-care system, and are important quality metrics. Data on 30-day readmission following Impella mechanical circulatory support (MCS) are unknown. We aimed to assess the rates, causes and clinical outcomes associated with 30-day unplanned readmissions after Impella mechanical circulatory support (MCS). METHODS: Discharged patients who underwent Impella MCS between 2016 and 2019 in the U.S. Nationwide Readmission Database were analyzed. Incidence, causes, and outcomes associated with 30-day unplanned readmissions were assessed. RESULTS: Of 22,055 patients who received Impella MCS, 2685 (12.2%) experienced 30-day readmissions. Cardiac readmissions accounted for 51.7% compared to 48.3% of non-cardiac readmissions, and most (70%) patients were readmitted back to the index hospital. Heart failure was the leading cause of cardiac readmissions accounting for 25% of them, whereas infections were the most common cause among non-cardiac readmissions. Patients who were readmitted were significantly older (median age 71 versus 68 years), more likely to be female (31% versus 26%) and had a shorter length-of-stay (index hospitalization, median 8 versus 9 days) compared to those who were not readmitted. Factors independently associated with 30-day readmissions were chronic renal (aOR: 1.46, 95% CI: 1.35-1.57), pulmonary (aOR: 1.23, 95% CI: 1.15-1.33), and liver disease (aOR: 1.38, 95% CI: 1.17-1.63), anemia (aOR: 1.35, 95% CI: 1.26-1.46), female sex (aOR: 1.21, 95% CI: 1.12-1.30), index admission on weekends (aOR: 1.23, 95% CI: 1.13-1.34), STEMI diagnosis (aOR: 1.16, 95% CI: 1.02-1.31), major adverse event during index hospitalization (aOR: 1.11, 95% CI: 1.00-1.24), prolonged length-of-stay (median 9 vs. 8 days, P < 0.001), and discharge against medical advice (aOR: 2.06, 95% CI: 1.37-3.09). Significantly higher mortality rates were overserved during readmissions to a hospital different than the MCS implanting hospital (12% versus 5.9%, P < 0.001). CONCLUSION: Thirty-day readmissions after Impella MCS are relatively common and relate to sex, baseline comorbidities, presentation, expected primary payer, discharge destination and initial length of hospital stay. Heart failure was the leading cause of cardiac readmissions, whereas infections were the most common cause among non-cardiac readmissions. Most patients were readmitted to the same hospital as their index admission for MCS. Higher mortality rates were observed when patients were readmitted to a different hospital.

The Relationship Between Hospital Stroke Center Designation and TVT Reported Stroke: The Michigan TAVR Experience.

BACKGROUND: The 30-day rate of stroke after transcatheter aortic valve replacement (TAVR) has been suggested as a hospital quality metric. Thirty-day stroke rates for nonsurgical, high, and moderate-risk TAVR trials were 3.4% to 6.1%, whereas those in the national Transcatheter Valve Therapy (TVT) Registry for the same patient population were much lower. Hospital comprehensive stroke center (CSC) is the highest designation for integrated acute stroke recognition, management, and care. OBJECTIVES: Using Michigan TVT data, we assessed whether in-hospital post-TAVR stroke rates varied between CSC and non-CSC institutions. METHODS: TVT data submitted from the 22 Michigan Transcatheter Aortic Valve Replacement Collaborative participating institutions between January 1, 2016, and June 30, 2019, were included (N = 6,231). Bayesian hierarchical regression models accounting for patient clinical characteristics and hospital clustering were fitted to assess the association between hospital CSC accreditation and in-hospital post-TAVR stroke. Adjusted ORs and 95% credible intervals were estimated. The University of Michigan Institutional Review Board has waived the need for the approval of studies based on the data collected by the Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry. RESULTS: There were 3,882 (62.3%) patients at 9 CSC sites and 2,349 (37.7%) patients at 13 non-CSC sites. CSC sites had significantly higher rates of in-hospital post-TAVR stroke (CSC: 2.65% vs non-CSC: 1.15%; P < 0.001). After adjustment, patients who underwent TAVR at a CSC hospital had a significantly higher risk of in-hospital stroke (adjusted OR: 2.21; 95% CI: 1.03-4.62). However, CSC designation was not significantly associated with other important post-TAVR clinical outcomes including 30-day mortality. CONCLUSIONS: Reported Michigan Transcatheter Aortic Valve Replacement Collaborative TVT stroke rates were significantly higher at sites with Joint Hospital Commission stroke designation status; however, other reported important clinical outcomes did not differ significantly based on this designation. CSC designation is a possible factor in stroke rate detection differences between TAVR institutions and might be a factor in the observed differences in stroke rates between TAVR trials and those reported in TVT. In addition, these data suggest that comparison between hospitals based on post-TAVR stroke rates is potentially problematic.

Trans-caval aspiration artherectomy/thrombectomy of large mobile plaques and thrombi in aortic arch and descending aorta.

Aspiration thrombectomy with the AngioVac is approved for percutaneous removal of thrombus in the venous system. While not approved for aspiration of thrombus or other mass in the left heart or arterial system, it has been used in that setting. Patients with left heart or arterial mass are often deemed unfavorable for surgery and treated conservatively. This may not be the best option for all patients, as some may have lesions that represent a short-term increased risk of complications, for which intervention and aspiration could be considered reasonable. Unfortunately, femoral arteries sizes often cannot accommodate the Angiovac current aspiration cannula dimensions. Here, we demonstrated trans-caval approach for aspiration thrombectomy of extensive aortic mobile plaque and thrombus.

Bilateral Transbrachial Intracardiac Echocardiography-Guided Patent Foramen Ovale Closure in Patient With Bilateral Deep Vein Thrombosis.

Patent foramen ovale (PFO) closure is a very common procedure, and unfavorable femoral venous access is not uncommonly encountered. The ability to treat this common condition in a minimally invasive manner via a different access is important in our daily practice. The transjugular venous approach has been successfully reported, with 1 main difficulty when faced with the angulation of the PFO septum primum during the crossing, as well as less operator-friendly in terms of positioning. Hence, we adopted the bilateral transbrachial approach in this patient. We consider this to be the first reported case of intracardiac echocardiography-guided PFO closure via bilateral transbrachial approach. The authors believe their experience serves an important role in the following: (1) steps and equipment needed for bilateral transbrachial PFO closure; (2) tips and tricks for a successful procedure; and (3) safety and feasibility of bilateral transbrachial approach as an alternative approach for minimally invasive PFO closure.

Transcatheter Edge-to-Edge Repair for Acute Mitral Regurgitation With Cardiogenic Shock Secondary to Mechanical Complication.

INTRODUCTION: Acute MR due to mechanical mitral valve (MV) complications frequently results in cardiogenic shock and requires emergency surgical intervention. There was limited evidence for alternative treatment like MitraClip for patients at prohibitive surgical risk. We aimed to study the technical features and outcomes of emergency transcatheter edge-to-edge repair (TEER) using the MitraClip system for patients with cardiogenic shock (CS) secondary to acute mitral regurgitation (MR) and mechanical MV complication. MATERIAL AND METHODS: We performed institutional review and systemic literature review to identify all TEER for CS patients due to acute mitral regurgitation and mechanical MV complication. Clinical endpoints included device success rate assessed at the end of procedure, ability to wean off MCS, all-cause and cardiovascular mortality at 30-day. RESULTS: Eight patients were identified from institutional review. Detail anatomical analysis found that patients with mechanical MV complications related to myocardial infarction had a lower transseptal height achieved during MitraClip (3.6 ± 0.1 cm vs 4.3 ± 0.3 cm, p = 0.03) than those not related. Pooled analysis for cases from institutional review (n = 8) and systemic literature review (n = 16) was performed. The device success rate was 68.8 %. Seventy-five percent (n = 18) cases required mechanical circulatory support (MCS), and 94.4 % were able to wean off MCS. At 30-day, the cardiovascular mortality was 4.5 % and the all-cause mortality was 9.1 %. CONCLUSIONS: In CS patients due to acute MR and mechanical MV complications, TEER with/without MCS was feasible with a reasonable device success rate.

Preclosure of large bore venous access sites in patients undergoing transcatheter mitral replacement and repair.

OBJECTIVE: We aim to report on the efficacy and safety of large bore venous access (LBVA) preclosure with Perclose™ (Abbott Vascular Devices) suture-mediated device use following transcatheter edge-to-edge (TEER) and replacement (TMVR). BACKGROUND: Patients requiring TEER and TMVR require LBVA. Clinical outcome data on the use of suture-mediated devices for LBVA site closure are limited. METHODS: Between 2012 and 2019, 354 consecutive high-risk patients with mitral valvular heart disease underwent TEER (n = 287) with MitraClip and TMVR (n = 67) with Edwards Sapien Valves. Patients had LBVA with 24 or 16 French sheaths. All patients underwent preclosure of LBVA except for one that underwent manual hemostasis. RESULTS: There were no closure device failures. None of the cases required surgical repair of the access site following venous preclosure. Two cases had large hematomas (>6 cm) following Perclose in each group. Six cases had small hematomas (<6 cm and >2 cm) with three in each group. There was one major bleeding using Mitral Valve Academic Research Consortium 2 definition (retroperitoneal bleed from arterial puncture) unrelated to the venous closure. Transfusion related to vascular access complication was required in five cases. There were two immediate acute deep venous thromboses postprocedure; one of which occurred after preclosure. There were no arteriovenous malformations, pseudoaneurysms, or access site infections reported following Perclose. CONCLUSION: In this large sample size analysis, Proglide preclosure technique is a feasible and safe alternative approach to achieving hemostasis after removal of LBVA sheaths in patients undergoing TEER and TMVR. Randomized trials are needed to compare the different modalities of hemostasis.