Mitral Transcatheter Edge-to-Edge Repair With the PASCAL Precision System: Device Knobology and Review of Advanced Steering Maneuvers.

In 2022, the Food and Drug Administration approved a second mitral transcatheter edge-to-edge repair device for the treatment of primary mitral regurgitation (PASCAL Precision Transcatheter Valve Repair System, Edwards Lifesciences, Irvine, CA). The PASCAL Precision system consists of a guide sheath, implant system, and accessories. The implant system consists of a steerable catheter, an implant catheter, and the implant (PASCAL or PASCAL Ace). The guide sheath and steerable catheter move and flex independently from each other and are not keyed, allowing for freedom of rotation in three dimensions. This manuscript provides an overview of the PASCAL Precision system and describes the basic and advanced steering maneuvers to facilitate effective and safe mitral transcatheter edge-to-edge repair.

The Mortality Burden of Untreated Aortic Stenosis.

BACKGROUND: The American College of Cardiology/American Heart Association guidelines recommend the assessment and grading of severity of aortic stenosis (AS) as mild, moderate, or severe, per echocardiogram, and recommend aortic valve replacement (AVR) when the AS is severe. OBJECTIVES: The authors sought to describe mortality rates across the entire spectrum of untreated AS from a contemporary, large, real-world database. METHODS: We analyzed a deidentified real-world data set including 1,669,536 echocardiographic reports (1,085,850 patients) from 24 U.S. hospitals (egnite Database, egnite). Patients >18 years of age were classified by diagnosed AS severity. Untreated mortality and treatment rates were examined with Kaplan-Meier (KM) estimates, with results compared using the log-rank test. Multivariate hazards analysis was performed to assess associations with all-cause mortality. RESULTS: Among 595,120 patients with available AS severity assessment, the KM-estimated 4-year unadjusted, untreated, all-cause mortality associated with AS diagnosis of none, mild, mild-to-moderate, moderate, moderate-to-severe, or severe was 13.5% (95% CI: 13.3%-13.7%), 25.0% (95% CI: 23.8%-26.1%), 29.7% (95% CI: 26.8%-32.5%), 33.5% (95% CI: 31.0%-35.8%), 45.7% (95% CI: 37.4%-52.8%), and 44.9% (95% CI: 39.9%-49.6%), respectively. Results were similar when adjusted for informative censoring caused by treatment. KM-estimated 4-year observed treatment rates were 0.2% (95% CI: 0.2%-0.2%), 1.0% (95% CI: 0.7%-1.3%), 4.2% (95% CI: 2.0%-6.3%), 11.4% (95% CI: 9.5%-13.3%), 36.7% (95% CI: 31.8%-41.2%), and 60.7% (95% CI: 58.0%-63.3%), respectively. After adjustment, all degrees of AS severity were associated with increased mortality. CONCLUSIONS: Patients with AS have high mortality risk across all levels of untreated AS severity. Aortic valve replacement rates remain low for patients with severe AS, suggesting that more research is needed to understand barriers to diagnosis and appropriate approach and timing for aortic valve replacement.

Outcomes in non-ST-segment elevation myocardial infarction complicated by in-hospital cardiac arrest based on management strategy.

BACKGROUND: There are limited data on in-hospital cardiac arrest (IHCA) complicating non-ST-segment-elevation myocardial infarction (NSTEMI) based on management strategy. METHODS: We used National Inpatient Sample (2000-2017) to identify adults with NSTEMI (not undergoing coronary artery bypass grafting) and concomitant IHCA. The cohort was stratified based on use of early (hospital day 0) or delayed (≥hospital day 1) coronary angiography (CAG), percutaneous coronary intervention (PCI), and medical management. Outcomes included incidence of IHCA, in-hospital mortality, adverse events, length of stay, and hospitalization costs. RESULTS: Of 6,583,662 NSTEMI admissions, 375,873 (5.7 %) underwent early CAG, 1,133,143 (17.2 %) received delayed CAG, 2,326,391 (35.3 %) underwent PCI, and 2,748,255 (41.7 %) admissions were managed medically. The medical management cohort was older, predominantly female, and with higher comorbidities. Overall, 63,085 (1.0 %) admissions had IHCA, and incidence of IHCA was highest in the medical management group (1.4 % vs 1.1 % vs 0.7 % vs 0.6 %, p < 0.001) compared to early CAG, delayed CAG and PCI groups, respectively. In adjusted analysis, early CAG (adjusted OR [aOR] 0.67 [95 % confidence interval {CI} 0.65-0.69]; p < 0.001), delayed CAG (aOR 0.49 [95 % CI 0.48-0.50]; p < 0.001), and PCI (aOR 0.42 [95 % CI 0.41-0.43]; p < 0.001) were associated with lower incidence of IHCA compared to medical management. Compared to medical management, early CAG (adjusted OR 0.53, CI: 0.49-0.58), delayed CAG (adjusted OR 0.34, CI: 0.32-0.36) and PCI (adjusted OR 0.19, CI: 0.18-0.20) were associated with lower in-hospital mortality (all p < 0.001). CONCLUSION: Early CAG and PCI in NSTEMI was associated with lower incidence of IHCA and lower mortality among NSTEMI-IHCA admissions.

Outcomes of repeat transcatheter aortic valve replacement with balloon-expandable valves: a registry study.

BACKGROUND: With increasing numbers of patients undergoing transcatheter aortic valve replacement (TAVR), data on management of failed TAVR, including repeat TAVR procedure, are needed. The aim of this study was to assess the safety and efficacy of redo-TAVR in a national registry. METHODS: This study included all consecutive patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from Nov 9, 2011, to Dec 30, 2022 who underwent TAVR with balloon-expandable valves in failed transcatheter heart valves (redo-TAVR) or native aortic valves (native-TAVR). Procedural, echocardiographic, and clinical outcomes were compared between redo-TAVR and native-TAVR cohorts using propensity score matching. FINDINGS: Among 350 591 patients (1320 redo-TAVR; 349 271 native-TAVR), 1320 propensity-matched pairs of patients undergoing redo-TAVR and native-TAVR were analysed (redo-TAVR cohort: mean age 78 years [SD 9]; 559 [42·3%] of 1320 female, 761 [57·7%] male; mean predicted surgical risk of 30-day mortality 8·1%). The rates of procedural complications of redo-TAVR were low (coronary compression or obstruction: four [0·3%] of 1320; intraprocedural death: eight [0·6%] of 1320; conversion to open heart surgery: six [0·5%] of 1319) and similar to native-TAVR. There was no significant difference between redo-TAVR and native-TAVR populations in death at 30 days (4·7% vs 4·0%, p=0·36) or 1 year (17·5% vs 19·0%, p=0·57), and stroke at 30 days (2·0% vs 1·9%, p=0·84) or 1 year (3·2% vs 3·5%, p=0·80). Redo-TAVR reduced aortic valve gradients at 1 year, although they were higher in the redo-TAVR group compared with the native-TAVR group (15 mm Hg vs 12 mm Hg; p<0·0001). Moderate or severe aortic regurgitation rates were similar between redo-TAVR and native-TAVR groups at 1 year (1·8% vs 3·3%, p=0·18). Death or stroke after redo-TAVR were not significantly affected by the timing of redo-TAVR (before or after 1 year of index TAVR), or by index transcatheter valve type (balloon-expandable or non-balloon-expandable). INTERPRETATION: Redo-TAVR with balloon-expandable valves effectively treated dysfunction of the index TAVR procedure with low procedural complication rates, and death and stroke rates similar to those in patients with a similar clinical profile and predicted risk undergoing TAVR for native aortic valve stenosis. Redo-TAVR with balloon-expandable valves might be a reasonable treatment for failed TAVR in selected patients. FUNDING: Edwards Lifesciences.

Structural Valve Deterioration in Transcatheter Aortic Bioprostheses: Diagnosis, Pathogenesis, and Treatment.

Transcatheter aortic valve replacement has emerged as the preferred treatment modality in most patients with severe aortic stenosis. With its global adoption and broader application in younger and healthier patients, the issue of transcatheter bioprosthetic valve degeneration and its impact on valve durability continues to earn clinical relevance. Differences in the pathophysiologic processes that separate native from transcatheter heart valve deterioration remain poorly understood. When compared to surgical aortic bioprostheses, the mechanisms of valve degeneration are similar in transcatheter heart valves, with meaningful differences most noticeably found between the individual constructs of their design. Recognizing the clinical and hemodynamic presentation of structural valve degeneration remains paramount. The recently revised consensus guidelines that incorporate the integration of advanced multimodality imaging with invasive hemodynamics represent a major step forward in our ability to accurately diagnose bioprosthetic valve degeneration, and to identify differences in durability patterns, and to establish treatment recommendations for the lifetime management of patients with aortic stenosis. Parallel efforts to unmask the biomolecular differences in atherosclerotic plaque burden, valve calcification, and thrombotic diathesis, including host immunocompetence, between the different available bioprostheses, will further advance the role of emerging valve tissue technologies to improve durability. As with surgical heart valves, the optimal treatment options for redo-transcatheter aortic valve replacement and surgical explant remain poorly understood. Ongoing translational research in bench testing coupled with prospectively designed core lab-adjudicated clinical trials are much needed. This report provides a contemporary overview of transcatheter structural valve degeneration, including evolving concepts in its pathogenesis, diagnosis, and treatment.

In-Hospital cardiac arrest complicating ST-elevation myocardial Infarction: Temporal trends and outcomes based on management strategy.

BACKGROUND: There are limited data on the relationship of ST-segment-elevation myocardial infarction (STEMI) management strategy and in-hospital cardiac arrest (IHCA). AIMS: To investigate the trends and outcomes of IHCA in STEMI by management strategy. METHODS: Adult with STEMI complicated by IHCA from the National Inpatient Sample (2000-2017) were stratified into early percutaneous coronary intervention (PCI) (day 0 of hospitalization), delayed PCI (PCI ≥ day 1), or medical management (no PCI). Coronary artery bypass surgery was excluded. Outcomes of interest included in-hospital mortality, adverse events, length of stay, and hospitalization costs. RESULTS: Of 3,967,711 STEMI admissions, IHCA was noted in 102,424 (2.6%) with an increase in incidence during this study period. Medically managed STEMI had higher rates of IHCA (3.6% vs 2.0% vs 1.3%, p < 0.001) compared to early and delayed PCI, respectively. Revascularization was associated with lower rates of IHCA (early PCI: adjusted odds ratio [aOR] 0.44 [95% confidence interval (CI) 0.43-0.44], p < 0.001; delayed PCI aOR 0.33 [95% CI 0.32-0.33], p < 0.001) compared to medical management. Non-revascularized patients had higher rates of non-shockable rhythms (62% vs 35% and 42.6%), but lower rates of multiorgan damage (44% vs 52.7% and 55.6%), cardiogenic shock (28% vs 65% and 57.4%) compared to early and delayed PCI, respectively (all p < 0.001). In-hospital mortality was lower with early PCI (49%, aOR 0.18, 95% CI 0.17-0.18), and delayed PCI (50.9%, aOR 0.18, 95% CI 0.17-0.19) (p < 0.001) compared to medical management (82.5%). CONCLUSION: Early PCI in STEMI impacts the natural history of IHCA including timing and type of IHCA.

Association of ACEI/ARB and statin prescribing patterns with mortality after Transcatheter Aortic Valve Replacement (TAVR): Findings from real-world claims data.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become the standard of care for most patients with severe aortic stenosis (AS), but the impact of medical therapy prescribing patterns on post-TAVR patients has not been thoroughly investigated. METHODS: We analyzed Optum claims data from 9,012 adults who received TAVR for AS (January 2014-December 2018). Pharmacy claims data were used to identify patients who filled ACEI/ARB and/or statin prescriptions during the study's 90-day landmark period post-TAVR. Kaplan-Meier and adjusted Cox Proportional Hazards models were used to evaluate the association of prescribing patterns with mortality during the 3-year follow-up period. Subgroup analyses were performed to examine the impact of 11 potential confounders on the observed associations. RESULTS: A significantly lower adjusted 3-year mortality was observed for patients with post-TAVR prescription for ACEI/ARBs (hazard ratio [HR] = 0.82, 95% confidence interval [CI] 0.74-0.91, P = .0003) and statins (HR = 0.85, 95% CI 0.77-0.94, P = .0018) compared to patients who did not fill prescriptions for these medications post-TAVR. Subgroup analyses revealed that the survival benefit associated with ACEI/ARB prescription was not affected by any of the potential confounding variables, except preoperative ACEI/ARB prescription was associated with significantly lower risk of mortality vs postoperative prescription only. No other subgroup variables had significant interactions associated with survival benefits, including preoperative use of statins. CONCLUSIONS: In this large-scale, real-world analysis of patients undergoing TAVR, the prescription of ACEI/ARB and statins was associated with a significantly lower risk of mortality at 3-years, especially in those where the medications were initiated preoperatively.

Prosthetic valve leaflet perforation resulting in critical aortic insufficiency: A rare late complication after use of Cor-knot®.

The implementation of automatic fasteners such as the Cor-knot® device (LSI Solutions, Inc.) has revolutionized the field of minimally invasive valvular surgery. Nonetheless, paravalvular regurgitation, valvular embolization, and early leaflet perforation are all potential complications which may occur. Late manifestations of leaflet perforation (>5-year postimplantation) are rare. Herein, we discuss a patient who underwent remote Trifecta® (St. Jude, Inc.) surgical aortic valve replacement presenting with symptomatic critical aortic regurgitation secondary to leaflet perforation from automatically fastened metallic Cor-knot® sutures.

Synchronous Type 3 EVAR Endoleaks at Multiple Sites Following Transfemoral Transcatheter Aortic Valve Replacement.

We describe a complication following transfemoral transcatheter aortic valve replacement in a patient who underwent remote endovascular abdominal aortic aneurysm repair. This report highlights technical complications to be vigilant of when using intravascular catheterization in patients with previous aneurysm repair while also showcasing synchronous type 3 endoleaks at multiple sites. (Level of Difficulty: Advanced.).

Uninterrupted Continuation of VV-ECMO Without Anticoagulation for 44 Days in COVID-19 ARDS: A Precarious Quandary.

Venovenous extracorporeal membrane oxygenation (VV-ECMO) has become a mainstay treatment modality for a select patient population who do not respond to conventional medical therapy suffering from severe acute respiratory distress syndrome (ARDS) due to COVID-19. This therapy necessitates the utilization of anticoagulation, whether unfractionated heparin or bivalirudin, to prevent thrombotic complications. Scarce are reports of VV-ECMO implementation leading to acute hemorrhage mandating cessation of anticoagulation in a patient suffering from COVID-19 ARDS. Herein, the authors report a case of a successful outcome in a COVID-19 ARDS patient who suffered an acute hemorrhagic complication leading to pre-emptive termination of systemic anticoagulation. The authors believe this to be one of the first such cases in the literature.

Right Ventricular Failure Manifesting in Corona Virus Disease 2019 Acute Respiratory Distress Syndrome: A Call to Transition from Venovenous Extracorporeal Membranous Oxygenation to Right Ventricular Assist Device Extracorporeal Membranous Oxygenation.

Often labeled the forgotten ventricle, the right ventricle's (RV) importance has been magnified over the last 2 years as providers witnessed how severe acute respiratory syndrome coronavirus 2 infection has a predilection for exacerbating RV failure. Venovenous extracorporeal membranous oxygenation (VV-ECMO) has become a mainstay treatment modality for a select patient population suffering from severe COVID-19 acute respiratory distress syndrome. Concomitant early implementation of a right ventricular assist device with ECMO (RVAD-ECMO) may confer benefit in patient outcomes. The underlying mechanism of RV failure in COVID-19 has a multifactorial etiopathogenesis; nonetheless, clinical evaluation of a patient necessitating RV support remains unchanged. Herein, the authors report the case of a critically ill patient who was transitioned from a conventional VV-ECMO Medtronic Crescent cannula to RVAD-ECMO, with the insertion of the LivaNova ProtekDuo dual-lumen RVAD cannula.

MitraClip repair of right-sided atrioventricular valve in a patient with congenitally corrected transposition of the great arteries: a case report.

BACKGROUND: Patients with congenitally corrected transposition of the great arteries (ccTGA) often develop tricuspid valve (systemic atrioventricular valve) dysfunction due to right ventricular overload and dilatation, but isolated mitral valve (MV) disease is rarely found. Isolated mitral (subpulmonic atrioventricular valve) interventions, specifically catheter-directed, have not been reported up to date. CASE SUMMARY: A man with ccTGA is evaluated for dyspnoea. Multimodality imaging assessment confirmed severe right-sided MV regurgitation due to prolapse. In light of high surgical risk, a minimally invasive transcatheter MitraClip procedure was pursued. DISCUSSION: To our knowledge, this is the first case of successful MV repair via percutaneous approach using MitraClip in a patient with ccTGA and biventricular failure. Our case illustrates the safety and feasibility of the edge-to-edge procedure in such a rare instance, but also the importance of multimodality imaging (both invasive and non-invasive) and the Heart Team approach when caring for these complex patients.

5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease.

OBJECTIVES: The aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). BACKGROUND: Patients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset. METHODS: Intermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate <60 mL/min/m2) from the PARTNER (Placement of Aortic Transcatheter Valve) 2A trial (patients randomly assigned to SAPIEN XT TAVR or SAVR) and SAPIEN 3 Intermediate Risk Registry were pooled. The composite primary outcome of death, stroke, rehospitalization, and new hemodialysis was evaluated using Cox regression analysis. Patients with and without perioperative acute kidney injury (AKI) were followed through 5 years. A core laboratory-adjudicated analysis of structural valve deterioration and bioprosthetic valve failure was also performed. RESULTS: The study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P < 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR. CONCLUSIONS: In intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses.

Management of peri-device leak following left atrial appendage closure: A systematic review.

OBJECTIVE: This study aimed to examine the cumulative experience of peri-device leak (PDL) closure following left atrial appendage (LAA) closure. BACKGROUND: The management of PDL following LAA closure remains controversial. While PDL closure has been proposed, procedural features and clinical outcomes have not been well established. METHODS: A systematic review of all published cases of PDL closure with available anatomical, procedural, and clinical outcomes was performed. RESULTS: We identified 18 indexed publications and 110 cases between April 2013 and March 2020. 71 patients (mean age 72 ± 8 yrs), met study criteria and were included. PDL closure was most common in males, bilobar LAA morphology, and after Watchman procedures. The mean PDL size was 7.6 ± 5.8 mm (range 2-26 mm). Leaks were classified according to size: small (<5 mm; 45%), moderate (≥5-9 mm; 25%), and large (≥10 mm; 30%). Endovascular coils and endovascular plugs were used to close both small and moderate sized leaks, and second LAA closure devices were exclusively used for large PDLs. Successful PDL closure occurred in 90%, and was similar between PDL sizes and types of occluder used. Procedural complication rates were uncommon (2.8%). No strokes were reported following PDL closure at 6 months. CONCLUSIONS: In patients with PDL for whom discontinuation of OAC may be considered unsafe, percutaneous closure using a tailored approach with either endovascular coils, plugs, or second occluder represents a safe, and feasible alternative associated with favorable clinical outcomes.

Impact of Transcatheter Aortic Valve Replacement on Severity of Chronic Kidney Disease.

BACKGROUND: The effect of transcatheter aortic valve replacement (TAVR) on kidney function stage in patients with aortic stenosis remains poorly understood. We hypothesized that in some patients, TAVR results in improved kidney function by alleviating cardiorenal syndrome. OBJECTIVES: The purpose of this study was to assess change in chronic kidney disease (CKD) stage following TAVR, identify variables associated with pre- and post-TAVR estimated glomerular filtration rate (eGFR), and assess association of post-TAVR eGFR with mortality. METHODS: Patients (n = 5,190) receiving TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) 1, 2, and PARTNER 2 S3 trials between April 2007 and October 2014 were included. Pre-TAVR and procedural variables associated with post-TAVR eGFR, change in CKD stage at ≤7 days post-TAVR, and association of post-TAVR eGFR on intermediate-term mortality were assessed. RESULTS: At baseline, CKD stage ≥2 was present in 91% of patients. CKD stage either improved or was unchanged following TAVR in the majority of patients (77% stage 1, 90% stage 2, 89% stage 3A, 94% stage 3B, and 99% stage 4). Progression to CKD stage 5 occurred in 1 (0.035%) of 2,892 patients within 7 days post-TAVR. Of 3,546 patients in whom data were available, 70 (2.0%) underwent post-TAVR dialysis. Higher pre-TAVR eGFR and transfemoral approach were strongly associated with higher post-TAVR eGFR. Lower baseline and longitudinal post-TAVR eGFR were associated with lower intermediate-term survival. CONCLUSIONS: In patients with severe aortic stenosis undergoing TAVR, even with baseline impaired eGFR, CKD stage is more likely to stay the same or improve than worsen. Aortic stenosis may contribute to cardiorenal syndrome that improves with TAVR.

'Minimalist approach' for transcatheter mitral valve replacement using intracardiac echocardiography and conscious sedation: a case series.

BACKGROUND: Transcatheter aortic valve implantation operators have adapted to a less invasive technique by foregoing the use of general anaesthesia and transoesophageal echocardiography. This is known as a 'minimalist approach'. This approach has yet to be explored in transcatheter mitral valve replacement (TMVR). Two patients with high perioperative risk underwent TMVR using only monitored conscious sedation (CS) and intracardiac echocardiography (ICE). CASE SUMMARY: The patients were symptomatic and required treatment of severe mitral regurgitation and severe mitral stenosis in a mitral valve ring and prosthetic mitral valve, respectively. With the use of an antegrade transseptal approach, the procedure was conducted under CS using ICE only. After placement of the prosthetic mitral valve, the valve was assessed by advancing the ICE catheter through the interatrial septal defect and no significant paravalvular leak occurred. In one case, ad hoc treatment of right to left shunting was successfully pursued. Valve function was excellent immediately and at 24 h after implantation and resulted in significant haemodynamic improvement. CONCLUSION: With more TMVR cases being conducted, the 'minimalist approach' with CS and ICE may be considered in selected cases.