Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System.

BACKGROUND: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths. METHODS: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure. RESULTS: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88). CONCLUSIONS: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558.

Artificial Intelligence for Education, Proctoring, and Credentialing in Cardiovascular Medicine.

Artificial intelligence and machine learning are rapidly gaining popularity in every aspect of cardiovascular medicine. This review discusses the past, present, and future of artificial intelligence in education, remote proctoring, credentialing, research, and publication as they pertain to cardiovascular procedures. This review describes the benefits and limitations of artificial intelligence and machine learning and the exciting potential of integrating advanced simulation, holography, virtual reality, and extended reality into disease diagnosis and patient care, as well as their roles in cardiovascular research and education. Nonetheless, much of the available data resides in electronic medical records or within industry-sponsored proprietary programs that are not compatible or standardized for current clinical application. Many areas in cardiovascular medicine would benefit from the introduction or increased use of artificial intelligence. Web-based artificial intelligence applications could be used to address unmet needs for education, on-demand procedural proctoring, credentialing, and recredentialing for interventionists and physicians in remote locations. Further progress in artificial intelligence will require further collaboration among computer scientists and researchers in order to identify and correct the most relevant problems and to implement the best data-based approach to achieving this goal. The future success of artificial intelligence in cardiovascular medicine will depend on the degree of collaboration between all pertinent experts in this field. This will undoubtedly be a prolonged, stepwise process.

Artificial Intelligence in Cardiovascular Medicine: Historical Overview, Current Status, and Future Directions.

Artificial intelligence and machine learning are rapidly gaining popularity in every aspect of our daily lives, and cardiovascular medicine is no exception. Here, we provide physicians with an overview of the past, present, and future of artificial intelligence applications in cardiovascular medicine. We describe essential and powerful examples of machine-learning applications in industry and elsewhere. Finally, we discuss the latest technologic advances, as well as the benefits and limitations of artificial intelligence and machine learning in cardiovascular medicine.

Frequency, Impact, and Predictors of Access Complications With Plug-Based Large-Bore Arteriotomy Closure - A Patient-Level Meta-Analysis.

BACKGROUND/PURPOSE: The MANTA is a dedicated plug-based large-bore vascular closure device (VCD) providing safe hemostasis in most patients, but data on the clinical impact and mechanisms of MANTA related complications are limited. This study sought to determine the frequency, impact and predictors of MANTA-related access complications. METHODS/MATERIALS: This patient-level meta-analysis included data from 2 medical device approval studies and 1 post-approval registry. The primary endpoint was the composite of major and minor access complications. Technical success was defined as hemostasis with MANTA closure device without need for vascular surgery or stenting. RESULTS: Eight hundred ninety-one patients (mean age 80) underwent transcatheter aortic valve replacement (n = 814), endovascular aortic repair (n = 71), balloon aortic valvuloplasty (n = 4) or mechanical circulatory support (n = 2). Technical success was 96.4% and median time to hemostasis was 31 (interquartile range: 17-76) seconds. The primary endpoint occurred 9.1% and bailout vascular surgery or stenting was necessary in 32 patients (3.6%). Female gender (OR: 2.63, CI: 1.46-4.73, p = 0.001), left femoral access (OR: 2.18, CI: 1.17-4.06, p = 0.015) and unfavorable arteriotomy phenotype (combination of a small femoral artery diameter with a deep arteriotomy; OR 2.27: 1.26-4.10, p = 0.006) independently predicted access complications. Access complications most often consisted of vessel dissection, stenosis or occlusion and predominantly occurred in patients with an unfavorable arteriotomy phenotype. CONCLUSIONS: Large-bore arteriotomy closure with MANTA VCD provided fast and safe hemostasis with an acceptable complication rate. Refined procedure planning and risk-stratification may further improve MANTA VCD performance.

Hemodynamic outcomes after valve-in-valve transcatheter aortic valve replacement: a single-center experience.

BACKGROUND: Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) has emerged as a safe, effective alternative to redo aortic valve surgery in high-risk patients with degenerated surgical bioprosthetic valves. However, ViV-TAVR has been associated high postprocedural valvular gradients, compared with TAVR for native-valve aortic stenosis. METHODS: We performed a retrospective study of all patients who underwent ViV-TAVR for a degenerated aortic valve bioprosthesis between January 1, 2013 and March 31, 2019 at our center. The primary outcome was postprocedural mean aortic valve gradient. Outcomes were compared across surgical valve type (stented versus stentless), surgical valve internal diameter (≤19 versus >19 mm), and transcatheter aortic valve type (self-expanding vs. balloon-expandable). RESULTS: Overall, 89 patients underwent ViV-TAVR. Mean age was 69.0±12.6 years, 61% were male, and median Society of Thoracic Surgeons Predicted Risk of Mortality score was 5.4 [interquartile range, 3.2-8.5]. Bioprosthesis mode of failure was stenotic (58% of patients), regurgitant (24%), or mixed (18%). The surgical valve was stented in 75% of patients and stentless in 25%. The surgical valve's internal diameter was ≤19 mm in 45% of cases. A balloon-expandable transcatheter valve was used in 53% of procedures. Baseline aortic valve area and mean gradients were 0.87±0.31 cm2 and 36±18 mmHg, respectively. These improved after ViV-TAVR to 1.38±0.55 cm2 and 18±11 mmHg at a median outpatient follow-up of 331 [67-394] days. Higher postprocedural mean gradients were associated with surgical valves having an internal diameter ≤19 mm (24±13 versus 16±8, P=0.002) and with stented surgical valves (22±11 versus 12±6, P<0.001). CONCLUSIONS: ViV-TAVR is an effective option for treating degenerated surgical aortic bioprostheses, with acceptable hemodynamic outcomes. Small surgical valves and stented surgical valves are associated with higher postprocedural gradients.

"Simple" Transcatheter Aortic Valve Replacement With Conscious Sedation: Safety and Effectiveness in Real-World Practice.

Transcatheter aortic valve replacement (TAVR) is a well-established alternative to open surgical replacement. Strictly selecting low-risk patients and using conscious sedation during TAVR has enabled hospital stays to be safely shortened. We evaluated the safety and effectiveness of a less rigorous patient-selection process involving multidisciplinary case discussions, percutaneous procedures with the use of conscious sedation, and postprocedural care outside an intensive care unit, with the goal of discharging patients from the hospital early. We call this "simple TAVR." We retrospectively reviewed the records of patients who underwent TAVR from March 2015 through February 2020 at our center. The procedures were performed by 2 high-volume operators. Of 524 total procedures, 344 (65.6%) qualified as simple TAVR. All 344 procedures were successful. The highest 30-day complication rate was associated with new permanent pacemaker implantation (7.3%, 25 patients); the rates of major vascular complications, stroke, and all-cause death were less than 3% each. Of note, 252 patients (73.3%) were discharged from the hospital the day after TAVR, and 307 (89.2%) within 48 hours. Simple TAVR is safe, economical, and feasible in real-world practice, and it does not necessitate a rigorous perioperative protocol or patient-selection process.