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.

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.

Transcatheter Treatment of Native Aortic Valve Regurgitation: The North American Experience With a Novel Device.

BACKGROUND: Transcatheter treatment of patients with native aortic valve regurgitation (AR) has been limited by anatomical factors. No transcatheter device has received U.S. regulatory approval for the treatment of patients with AR. OBJECTIVES: The aim of this study was to describe the compassionate-use experience in North America with a dedicated transcatheter device (J-Valve). METHODS: A multicenter, observational registry was assembled of compassionate-use cases of J-Valve implantation for the treatment of patients with severe symptomatic AR and elevated surgical risk in North America. The J-Valve consists of a self-expanding Nitinol frame, bovine pericardial leaflets, and a valve-locating feature. The available size matrix (5 sizes) can treat a wide range of anatomies (minimum and maximum annular perimeters 57-104 mm). RESULTS: A total of 27 patients (median age 81 years [IQR: 72-85 years], 81% at high surgical risk, 96% in NYHA functional class III or IV) with native valve AR were treated with the J-Valve during the study period (2018-2022). Procedural success (J-Valve delivered to the intended location without the need for surgical conversion or a second transcatheter heart valve) was 81% (22 of 27 cases) in the overall experience and 100% in the last 15 cases. Two cases required conversion to surgery in the early experience, leading to changes in valve design. At 30 days, there was 1 death, 1 stroke, and 3 new pacemakers (13%), and 88% of patients were in NYHA functional class I or II. No patient had residual AR of moderate or greater degree at 30 days. CONCLUSIONS: The J-Valve appears to provide a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk.

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.

Sex-Based Differences in Outcomes With Percutaneous Transcatheter Repair of Mitral Regurgitation With the MitraClip System: Transcatheter Valve Therapy Registry From 2011 to 2017.

BACKGROUND: Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery. METHODS: The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes. RESULTS: From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted (P<0.001) and had a lower adjusted odds ratio of device success (adjusted odds ratio, 0.78 [95% CI, 0.67-0.90]), driven by lower odds of residual mitral gradient <5 mm Hg (adjusted odds ratio, 0.54 [CI, 0.46-0.63]) when compared with males. At 1-year follow-up, the primary outcome did not differ by sex. Female sex was associated with lower adjusted 1-year risk of all-cause mortality (adjusted hazard ratio, 0.80 [CI, 0.68-0.94]), but the adjusted 1-year risk of stroke and any bleeding did not differ by sex. CONCLUSIONS: No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.

Neurologic Complications in Transcatheter Aortic Valve Replacement.

Transcatheter aortic valve replacement (TAVR) has become the mainstay of treatment for severe symptomatic aortic stenosis. Although many TAVR complication rates including mortality and aortic regurgitation have decreased, stroke rates have remained stable for years. TAVR-related strokes are devastating to patients and their families, and very costly for health care systems. The predictors of stroke in TAVR are not yet well defined, although older age, female gender, carotid and peripheral arterial disease, bicuspid aortic valve anatomy, and atrial fibrillation are emerging as risk factors across studies.

Additive Value of Preprocedural Computed Tomography Planning Versus Stand-Alone Transesophageal Echocardiogram Guidance to Left Atrial Appendage Occlusion: Comparison of Real-World Practice.

Background Transesophageal echocardiogram is currently the standard preprocedural imaging for left atrial appendage occlusion. This study aimed to assess the additive value of preprocedural computed tomography (CT) planning versus stand-alone transesophageal echocardiogram imaging guidance to left atrial appendage occlusion. Methods and Results We retrospectively reviewed 485 Watchman implantations at a single center to compare the outcomes of using additional CT preprocedural planning (n=328, 67.6%) versus stand-alone transesophageal echocardiogram guidance (n=157, 32.4%) for left atrial appendage occlusion. The primary end point was the rate of successful device implantation without major peri-device leak (>5 mm). Secondary end points included major adverse events, total procedural time, delivery sheath and devices used, risk of major peri-device leak and device-related thrombus at follow-up imaging. A single/anterior-curve delivery sheath was used more commonly in those who underwent CT imaging (35.9% versus 18.8%; P<0.001). Additional preprocedural CT planning was associated with a significantly higher successful device implantation rate (98.5% versus 94.9%; P=0.02), a shorter procedural time (median, 45.5 minutes versus 51.0 minutes; P=0.03) and a less frequent change of device size (5.6% versus 12.1%; P=0.01), particularly device upsize (4% versus 9.4%; P=0.02). However, there was no significant difference in the risk of major adverse events (2.1% versus 1.9%; P=0.87). Only 1 significant peri-device leak (0.2%) and 5 device-related thrombi were detected in follow-up (1.2%) with no intergroup difference. Conclusions Additional preprocedural planning using CT in Watchman implantation was associated with a higher successful device implantation rate, a shorter total procedural time, and a less frequent change of device sizes.

Short- and mid-term outcomes in percutaneous mitral valve replacement using balloon expandable valves.

BACKGROUND: Due to elevated surgical risk, transcatheter mitral valve replacement (TMVR) is used as an alternative for treating failed bioprosthetic valves, annuloplasty repairs and mitral annular calcification (MAC). We report the procedural and longitudinal outcomes for each subtype: Mitral valve-in-valve (MVIV), mitral valve-in-ring (MViR), and valve-in-MAC (ViMAC). METHODS: Consecutive patients undergoing TMVR from October 2013 to December 2019 were assessed. Patients at high risk for left ventricular outflow tract obstruction had either alcohol septal ablation or intentional laceration of the anterior leaflet (LAMPOON). RESULTS: Eight-eight patients underwent TMVR; 38 MViV, 31 MViR, and 19 ViMAC procedures were performed. The median Society of Thoracic Surgery 30-day predicted risk of mortality was 8.2% (IQR 5.2, 19.9) for all. Sapien 3 (78%) and transseptal access (98%) were utilized in most cases. All-cause in-hospital mortality, technical, and procedural success were 8%, 83%, and 66% respectively. Median follow up was 1.4 years (IQR 0.5-2.9 years) and overall survival was 40% at 4 years. Differential survival rates were observed with MViV doing the best, followed by MViR and ViMAC having a <20% survival at 4 years. After adjusting for co-variates, MViV procedure was the strongest predictor of survival (HR 0.24 [95% CI 0.079-0.7]). CONCLUSION: TMVR is performed in at high-risk patients with attenuated long-term survival. MViV has the best success and survival rate, but long-term survival in MViR and ViMAC is guarded.

Procedural and Mid-Term Outcomes of Coronary Protection During Transcatheter Aortic Valve Replacement in Patients at Risk of Coronary Occlusion: Insight From a Single-Centre Retrospective Analysis.

BACKGROUND: Detailed procedural analysis and long-term data is limited for coronary protection (CP) during transcatheter aortic valve replacement (TAVR) for patients with high anatomical risk for coronary occlusion (CO). We aim to assess the procedural and mid-term outcomes of CP during TAVR. METHODS: We retrospectively analyzed patients who underwent TAVR at Henry Ford Hospital, USA from January 2015 to August 2019 and identified those considered at risk of CO and underwent pre-emptive CP with or without subsequent "chimney" stenting (i.e. coronary stenting with intentional protrusion into the aorta). Procedural features, immediate and mid-term clinical outcomes were reviewed. RESULTS: Twenty-five out of 1166 (2.1%) patients underwent TAVR with CP, including 10 (40%) valve-in-valve procedures. Twenty-eight coronary arteries (Left: n = 11, Right: n = 11; Left + Right: n = 3) were protected. Eleven coronaries (39.3%) were electively "chimney"-stented due to angiographic evidence of coronary impingement (63.6%), tactile resistance while withdrawing stent (27.3%) and electrocardiogram change (9.1%). Twenty-four patients (24/25, 96%) had successful TAVR without CO. Procedure-related complications included stent-balloon entrapment (n = 1), stent entrapment (n = 1) and occlusive distal stent edge dissection (n = 1). After a mean follow-up of 19.1 months, there was 1 cardiac death but no target vessel re-intervention or myocardial infarction. CONCLUSIONS: Our study found that angiographic evidence of coronary impingement (63.6%) was the most common reason for stent deployment during TAVR with CP. The mid-term clinical outcome of CP with TAVR was favorable.

Percutaneous Approaches to the Treatment of Mitral Leaflet Perforation and to Residual Regurgitation After Transcatheter Edge-to-Edge Mitral Valve Repair.

Mitral valve disease becomes more prevalent as the population ages. As the number of percutaneous mitral valve interventions expands, obscure clinical scenarios may emerge and challenge conventional treatment algorithms. Strategies for dealing with complex repairs build on prior experience in mitral perivalvular leak repair. Cases using nitinol- and expanded polytetrafluoroethylene-based devices are used to treat mitral regurgitation in cases of focal mitral perforations and leaks between previously placed mitral valve edge-to-edge devices. This review discusses risks and benefits of performing such complex mitral repairs and informs clinicians of the strengths of weaknesses of different occluder devices in the mitral position.

Comparison of Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Patients ≥80 Years of Age.

Transcatheter aortic valve implantation (TAVI) procedures have increased exponentially since FDA approval in 2011. Older patients who underwent aortic valve replacement, either TAVI or surgical aortic valve replacement (SAVR), have elevated risk. Using the National Readmission Database, we included patients ≥80 years who underwent either TAVI or SAVR from 2011 to 2015. In-hospital outcomes of TAVI versus SAVR were compared using propensity-matched analysis to reduce the confounding effect of between-group imbalances. We identified a total of 30,590 TAVI and 54,204 SAVR procedures performed during the study period. The propensity score-matching algorithm yielded 19,713 patients in each group. The in-hospital mortality rates were significantly lower in TAVI compared with SAVR (3.4% vs 6.8%, p <0.001). Similarly, the 30-day readmission rate (15.2% vs 18.1% p = 0.001), in-hospital complications, mean length of stay (7 vs 12 days, p <0.001), and hospital cost (US$ 60,534 vs US$ 67,426) were significantly lower for TAVI patients. There was a significant increase in the use of TAVI (26 cased per month in 2011 to 1,237/month in 2015) and a decrease in SAVR (1,409/month in 2011 to 859/month in 2015) during the study period. In-patient mortality significantly decreased for patients who underwent TAVI (4.4% in 2011 to 2.5% in 2015) and did not significantly change for patients who underwent SAVR (5.0% in 2011 to 4.7% in 2015). Overall, the number of SAVR procedures remained two thirds higher than TAVI. In conclusion, in octo- and nonagenarians, TAVI is an effective and safer alternative to SAVR as it is associated with lower in-hospital mortality, lower major in-hospital complications, lower 30-day readmission rate, and hospital costs. Despite this, SAVR remained the most common approach in octogenarians, although the trends in this data set, suggest a shift in practice patterns for this cohort.

Henry Ford HEART Score Randomized Trial: Rapid Discharge of Patients Evaluated for Possible Myocardial Infarction.

BACKGROUND: Hospital evaluation of patients with chest pain is common and costly. The HEART score risk stratification tool that merges troponin testing into a clinical risk model for evaluation emergency department patients with possible acute myocardial infarction (AMI) has been shown to effectively identify a substantial low-risk subset of patients possibly safe for early discharge without stress testing, a strategy that could have tremendous healthcare savings implications. METHOD AND RESULTS: A total of 105 patients evaluated for AMI in the emergency departments of 2 teaching hospitals in the Henry Ford Health System (Detroit and West Bloomfield, MI), between February 2014 and May 2015, with a modified HEART score ≤3 (which includes cardiac troponin I <0.04 ng/mL at 0 and 3 hours) were randomized to immediate discharge (n=53) versus management in an observation unit with stress testing (n=52). The primary end points were 30-day total charges and length of stay. Secondary end points were all-cause death, nonfatal AMI, rehospitalization for evaluation of possible AMI, and coronary revascularization at 30 days. Patients randomized to early discharge, compared with those who were admitted for observation and cardiac testing, spent less time in the hospital (median 6.3 hours versus 25.9 hours; P<0.001) with an associated reduction in median total charges of care ($2953 versus $9616; P<0.001). There were no deaths, AMIs, or coronary revascularizations in either group. One patient in each group was lost to follow-up. CONCLUSIONS: Among patients evaluated for possible AMI in the emergency department with a modified HEART score ≤3, early discharge without stress testing as compared with transfer to an observation unit for stress testing was associated with significant reductions in length of stay and total charges, a finding that has tremendous potential national healthcare expenditure implications. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT03058120.