by
Vasilis Babaliaros;
Adam Greenbaum;
Patrick Gleason;
SM Chadderdon;
MF Eleid;
JJ Thaden;
R Makkar;
M Nakamura;
S Kodali;
RT Hahn;
KP Koulogiannis;
L Marcoff;
P Grayburn;
RL Smith;
HK Song;
DS Lim;
WA Gray;
K Hawthorne;
F Deuschl;
A Narang;
C Davidson;
FE Zahr
Patients with severe symptomatic tricuspid regurgitation face a significant dilemma in treatment options, as the yearly mortality with medical therapy and the surgical mortality for tricuspid repair or replacement are high. Transcatheter edge-to-edge repair (TEER) for the tricuspid valve is becoming a viable option in patients, although procedural success is dependent on high-quality imaging. While transesophageal echocardiography remains the standard for tricuspid TEER procedures, intracardiac echocardiography (ICE) with three-dimensional (3D) multiplanar reconstruction (MPR) has many theoretical and practical advantages. The aim of this article was to describe the in vitro wet lab–based imaging work done to facilitate the best approach to 3D MPR ICE imaging and the procedural experience gained with 3D MPR ICE in tricuspid TEER procedures with the PASCAL device.
BACKGROUND: Left ventricular outflow tract obstruction complicates hypertrophic cardiomyopathy and transcatheter mitral valve replacement. Septal reduction therapies including surgical myectomy and alcohol septal ablation are limited by surgical morbidity or coronary anatomy and high pacemaker rates, respectively. We developed a novel transcatheter procedure, mimicking surgical myotomy, called Septal Scoring Along the Midline Endocardium (SESAME). METHODS: SESAME was performed in 5 naive pigs and 5 pigs with percutaneous aortic banding–induced left ventricular hypertrophy. Fluoroscopy and intracardiac echocardiography guided the procedures. Coronary guiding catheters and guidewires were used to mechanically enter the basal interventricular septum. Imparting a tip bend to the guidewire enabled intramyocardial navigation with multiple df. The guidewire trajectory determined the geometry of SESAME myotomy. The myocardium was lacerated using transcatheter electrosurgery. Cardiac function and tissue characteristics were assessed by cardiac magnetic resonance at baseline, postprocedure, and at 7- or 30-day follow-up. RESULTS: SESAME myotomy along the intended trajectory was achieved in all animals. The myocardium splayed after laceration, increasing left ventricular outflow tract area (753 to 854 mm2, P=0.008). Two naive pigs developed ventricular septal defects due to excessively deep lacerations in thin baseline septa. No hypertrophy model pig, with increased septal thickness and left ventricular mass compared with naive pigs, developed ventricular septal defects. One animal developed left axis deviation on ECG but no higher conduction block was seen in any animal. Coronary artery branches were intact on angiography with no infarction on cardiac magnetic resonance late gadolinium imaging. Cardiac magnetic resonance chamber volumes, function, flow, and global strain were preserved. No myocardial edema was evident on cardiac magnetic resonance T1 mapping. CONCLUSIONS: This preclinical study demonstrated feasibility of SESAME, a novel transcatheter myotomy to relieve left ventricular outflow tract obstruction. This percutaneous procedure using available devices, with a safe surgical precedent, is readily translatable into patients. GRAPHIC ABSTRACT: A graphic abstract is available for this article.
Transcatheter mitral valve replacement (TMVR) using the SAPIEN platform has been performed in failed bioprosthetic valves (valve-in-valve), surgical annuloplasty rings (valve-in-ring), and native valves with mitral annular calcification (MAC) (valve-in-MAC). Experience over the past decade has identified important challenges and solutions to improve clinical outcomes. In this review, we discuss the indication, trend in utilization, unique challenges, procedural planning, and clinical outcomes of valve-in-valve, valve-in-ring, and valve-in-MAC TMVR.
Objectives: The aim of this study was to compare transcaval and transaxillary artery access for transcatheter aortic valve replacement (TAVR) at experienced medical centers in contemporary practice. Background: There are no systematic comparisons of transcaval and transaxillary TAVR access routes. Methods: Eight experienced centers contributed local data collected for the STS/ACC TVT Registry (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry) between 2017 and 2020. Outcomes after transcaval and axillary/subclavian (transaxillary) access were adjusted for baseline imbalances using doubly robust (inverse propensity weighting plus regression) estimation and compared. Results: Transcaval access was used in 238 procedures and transaxillary access in 106; for comparison, transfemoral access was used in 7,132 procedures. Risk profiles were higher among patients selected for nonfemoral access but similar among patients requiring transcaval and transaxillary access. Stroke and transient ischemic attack were 5-fold less common after transcaval than transaxillary access (2.5% vs 13.2%; OR: 0.20; 95% CI: 0.06-0.72; P = 0.014) compared with transfemoral access (1.7%). Major and life-threatening bleeding (Valve Academic Research Consortium 3 ≥ type 2) were comparable (10.0% vs 13.2%; OR: 0.66; 95% CI: 0.26-1.66; P = 0.38) compared with transfemoral access (3.5%), as was blood transfusion (19.3% vs 21.7%; OR: 1.07; 95% CI: 0.49-2.33; P = 0.87) compared with transfemoral access (7.1%). Vascular complications, intensive care unit and hospital length of stay, and survival were similar between transcaval and transaxillary access. More patients were discharged directly home and without stroke or transient ischemic attack after transcaval than transaxillary access (87.8% vs 62.3%; OR: 5.19; 95% CI: 2.45-11.0; P < 0.001) compared with transfemoral access (90.3%). Conclusions: Patients undergoing transcaval TAVR had lower rates of stroke and similar bleeding compared with transaxillary access in a contemporary experience from 8 US centers. Both approaches had more complications than transfemoral access. Transcaval TAVR access may offer an attractive option.
Coronary artery obstruction is a devastating complication of transcatheter aortic valve replacement (TAVR). Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery Obstruction (BASILICA) is a transcatheter, electrosurgical technique that was developed to prevent obstruction due to sinus effacement or sinus sequestration. BASILICA creates a midline laceration of one (solo) or both (doppio) offending aortic leaflets and has been performed in over 1,000 patients at high risk for obstruction. The procedure has been studied in the prospective BASILICA IDE Trial and data from the International BASILICA Registry of 214 patients supports efficacy and safety; procedural success was achieved in 94.4% and at thirty days 95.3% were free from culprit coronary artery obstruction, all-cause mortality was 2.8% and disabling stroke was reported in only 0.5%. In this review we discuss screening for patients at high risk for coronary artery obstruction, technical details related to performing the BASILICA procedure and how to troubleshoot a BASILICA procedure.
Transcatheter electrosurgery is a versatile tool that can be used to cut cardiac tissue without the need for a sternotomy, cardiopulmonary bypass, and cardioplegia. With adequate imaging and suitable anatomy, any cardiac tissue can be cut. Thus, transcatheter electrosurgery can provide bespoke therapies for complex patients who often have no other good treatment options. In this review, we will discuss the common applications for electrosurgical tissue traversal and laceration, including transcaval access, BASILICA, LAMPOON, and ELASTA-Clip, summarizing the evidence and the key technical steps for each.
by
Dirk Westermann;
Sebastian Ludwig;
Daniel Kalbacher;
Clemens Spink;
Matthias Linder;
Oliver D Bhadra;
Julius Nikorowitsch;
Lara Waldschmidt;
Till Demal;
Lisa Voigtlander;
Andreas Schaefer;
Moritz Seiffert;
Simon Pecha;
Niklas Schofer;
Adam Greenbaum;
Hermann Reichenspurner;
Stefan Blankenberg;
Lenard Conradi;
Johannes Schirmer
The original version of this article, published on June 22, 2021, contained a mistake. The affiliations were assigned incorrectly. The correct information is given above. The original article has been corrected.