Novel TEVAR technique for thoracic aortic aneurysm repair: A case report.

INTRODUCTION AND IMPORTANCE: A thoracic aortic aneurysm (TAA) is a life-threatening condition affecting 5-10 per 100,000 people per year. If not repaired, mortality rates are reported as high as 11.8 %, increasing to 97 %-100 % following a TAA rupture. Thoracic endovascular aortic repairs (TEVAR) are becoming more common, but currently face limitations due to complex vasculature. New techniques may provide a safer alternative. CASE PRESENTATION: 70-year-old male presenting with a history of hypertension, dyslipidemia, and previous replacement of ascending aorta and hemi arch with reimplantation of innominate artery done in 2020. A CT scan done during routine interval monitoring of previous TAA repair demonstrated a new aneurysm, which was confirmed with CT angiogram. A novel TEVAR technique was used for repair. The patient tolerated this procedure well and was discharged from the ICU after six days. CLINICAL DISCUSSION: Open procedures and hybrid techniques for TAA repair are not always suitable for high-risk patients. Alternative parallel grafting techniques have shown promising early results but still lack clinical support and long-term data. Several small-scale studies and case reports have demonstrated the use of in-situ laser fenestrations in various settings, but none have demonstrated the ability to extend the landing zone as far as zone 0 for repair of a Type B TAA. CONCLUSION: The use of this novel technique may be considered suitable in high-risk patients with various subtypes of TAAs not suitable for open repair. More cases and clinical trials are needed to compare risks and long-term results to more commonly performed procedures.

1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results.

BACKGROUND: High surgical risk may preclude mitral valve replacement in many patients. Transcatheter mitral valve replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients. OBJECTIVES: This analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study in patients with ≥moderate-severe MR. METHODS: The Intrepid TMVR Early Feasibility Study is a multicenter, prospective, single-arm study. Clinical events were adjudicated by a clinical events committee; endpoints were defined according to Mitral Valve Academic Research Consortium criteria. RESULTS: A total of 33 patients, enrolled at 9 U.S. sites between February 2020 and August 2022, were included. The median age was 80 years, 63.6% of patients were men, and mean Society of Thoracic Surgeons Predicted Risk of Mortality for mitral valve replacement was 5.3%. Thirty-one (93.9%) patients were successfully implanted. Median postprocedural hospitalization length of stay was 5 days, and 87.9% of patients were discharged to home. At 30 days, there were no deaths or strokes, 8 (24.2%) patients had major vascular complications and none required surgical intervention, there were 4 cases of venous thromboembolism all successfully treated without sequelae, and 1 patient had mitral valve reintervention for severe left ventricular outflow tract obstruction. At 1 year, the Kaplan-Meier all-cause mortality rate was 6.7%, echocardiography showed ≤mild valvular MR, there was no/trace paravalvular leak in all patients, median mitral valve mean gradient was 4.6 mm Hg (Q1-Q3: 3.9-5.3 mm Hg), and 91.7% of survivors were in NYHA functional class I/II with a median 11.4-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary scores. CONCLUSIONS: The early benefits of the Intrepid transfemoral transseptal TMVR system were maintained up to 1 year with low mortality, low reintervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function.

Outcomes in Patients With Asymptomatic Aortic Stenosis (from the Evolut Low Risk Trial).

Transcatheter aortic valve implantation (TAVI) has comparable outcomes with surgical aortic valve replacement (SAVR) in symptomatic patients with severe aortic stenosis, including those at low risk for surgery. Less is known about TAVI outcomes in asymptomatic patients. This analysis compares clinical, hemodynamic, and quality of life (QOL) outcomes after TAVI or SAVR for low-risk asymptomatic patients. The randomized Evolut Low Risk trial enrolled asymptomatic patients treated with TAVI (n = 76) and SAVR (n = 62). New York Heart Association functional class I identified patients without symptoms. Clinical outcomes, echocardiographic findings, and QOL in both groups were compared 30 days and 12 months after AVR. Asymptomatic patients had a mean Society of Thoracic Surgeons score of 1.7 ± 0.6, 73% were men, and mean age was 74.2 ± 5.8 years. The composite end point of all-cause mortality or disabling stroke was similar at 12 months in patients with TAVI (1.3%) and SAVR (6.5%; p = 0.11), although patients with SAVR tended to have higher rates of all-cause mortality (4.8%) compared with patients with TAVI (0.0%, p = 0.05). Patients with TAVI had lower mean aortic valve gradients (8.1 ± 3.2 mm Hg) and larger mean effective orifice area (2.3 ± 0.6 mm Hg) than patients with SAVR (10.8 ± 3.8; p <0.001 and 1.9 ± 0.6; p = 0.001, respectively), and showed significant improvement in Kansas City Cardiomyopathy Questionnaire scores from baseline to 30 days (∆12.1 ± 23.6; p <0.001), whereas patients with SAVR did not (∆2.2 ± 20.3; p = 0.398). Patients with TAVI and SAVR had a significant improvement in QOL by 12 months compared with baseline. In conclusion, low risk asymptomatic patients with severe aortic stenosis who underwent TAVI had comparable clinical outcomes to SAVR, with superior valve performance and faster QOL improvement.

Propensity-Matched 1-Year Outcomes Following Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients.

OBJECTIVES: The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement (TAVR) in low surgical risk patients with bicuspid aortic stenosis to patients with tricuspid aortic stenosis. BACKGROUND: The pivotal TAVR trials excluded patients with bicuspid aortic valves. The Low Risk Bicuspid Study 30-day primary endpoint of death or disabling stroke was 1.3%. METHODS: The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled patients from 25 U.S. sites. A screening committee confirmed bicuspid anatomy and valve classification on computed tomography using the Sievers classification. Valve sizing was by annular measurements. An independent clinical events committee adjudicated all serious adverse events, and an independent core laboratory assessed all echocardiograms. The 150 patients from the Low Risk Bicuspid Study were propensity matched to the TAVR patients in the randomized Evolut Low Risk Trial using the 1:1 5- to-1-digit greedy method, resulting in 145 pairs. RESULTS: All-cause mortality or disabling stroke at 1 year was 1.4% in the bicuspid and 2.8% in the tricuspid group (P = 0.413). A pacemaker was implanted in 16.6% of bicuspid and 17.9% of tricuspid patients (P = 0.741). The effective orifice area was similar between groups at 1 year (2.2 ± 0.7 cm2 vs 2.3 ± 0.6 cm2, P = 0.677) as was the mean gradient (8.7 ± 3.9 mm Hg vs 8.5 ± 3.1 mm Hg, P = 0.754). Fewer patients in the bicuspid group had mild or worse paravalvular leak (21.3% vs 42.6%, P < 0.001). CONCLUSIONS: There were no significant differences in clinical or forward flow hemodynamic outcomes between the propensity-matched groups at 1 year.

30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results.

OBJECTIVES: The aim of this study was to evaluate outcomes of transcatheter mitral valve replacement (TMVR) with transfemoral access in patients at prohibitive or high surgical risk. BACKGROUND: Prohibitive surgical risk may preclude mitral valve replacement surgery in some patients. The investigational Intrepid TMVR system has previously been evaluated using transapical access for delivery of a self-expanding bioprosthetic valve. METHODS: This prospective, multicenter, nonrandomized early feasibility study evaluated the safety and performance of the Intrepid valve using transfemoral access enabling transseptal delivery in patients with moderate to severe or severe symptomatic mitral regurgitation at high surgical risk. Candidacy was determined by heart teams, with approval by a central screening committee. Echocardiographic data were evaluated by an independent core laboratory. Clinical events were adjudicated by a clinical events committee. RESULTS: Fifteen patients were enrolled at 6 sites from February 2020 to May 2021. The median age was 80 years, and median Society of Thoracic Surgeons Predicted Risk of Mortality was 4.7%; 87% of patients were men, and 53% had undergone prior sternotomy. Fourteen implants were successful. One patient was converted to surgery during the index procedure. Patients stayed a median of 5 days postprocedure. There were 6 access site bleeds (40%) and 11 iatrogenic atrial septal defect closures (73%). At 30 days, there were no deaths, strokes, or reinterventions. All patients undergoing implantation had trace or no valvular or paravalvular mitral regurgitation, and the mean gradient was 4.7 mm Hg (IQR: 3.0-6.7 mm Hg). CONCLUSIONS: Thirty-day results from the Intrepid transfemoral TMVR early feasibility study demonstrate excellent valve function and no mortality or stroke. Additional patients and longer follow-up are needed to confirm these findings. ([The Early Feasibility Study of the Intrepid™ TMVR Transseptal System]; NCT02322840).

Six-month angiographic evaluation of beating-heart coronary arterial graft interrupted anastomoses using the coalescent U-CLIP anastomotic device: a prospective clinical study.

BACKGROUND: Interrupted suture technique avoids the "purse string" and puckering effects frequently seen with continuous suture techniques and should represent the standard of care in the creation of high-quality vascular anastomoses. This clinical study evaluated the safety and effectiveness of a self-closing surgical clip (Coalescent Surgical U-CLIP Anastomotic Device [U-CLIP]) designed to facilitate this interrupted technique. Left internal mammary artery (LIMA) to left anterior descending (LAD) coronary bypass grafting was studied. METHODS: Eighteen patients meeting inclusion criteria were enrolled (October 2000 through September 2001) into this prospective study. Anastomoses were performed using a beating-heart median sternotomy procedure (off-pump coronary artery bypass) in 17 cases (94%) and a minimally invasive beating-heart procedure (minimally invasive direct coronary artery bypass [MIDCAB]) in one case (6%). Six-month follow-up was completed on 18 patients (100%), with angiograms performed on 17 patients (94%) at a mean of 179 days (range, 168-191 days). Qualitative and quantitative angiographic assessment was performed by an independent core laboratory. RESULTS: The U-CLIP was used for 18 LIMA-to-LAD interrupted anastomoses without the requirement for knot tying or suture management and with no device-related morbidity or mortality. Mean LIMA-to-LAD anastomosis time was 8.6 minutes (range, 5-14 minutes). All anastomoses were FitzGibbon grade A at 6 months postprocedure. Quantitative analysis showed mean luminal diameters proximal to the anastomosis of 2.32 mm, at the anastomosis of 2.25 mm, and immediately distal to anastomosis of 1.99 mm. The average ratio of anastomosis to LAD diameter was 1.17 (range, 0.93- 1.93). Anastomotic stenosis as a percentage of average LIMA/LAD diameter was a negative 4.2%, comparing favorably with the 23% to 24% reported in the POEM (Patency, Outcomes, Economics of MIDCAB) study. CONCLUSIONS: The interrupted technique, facilitated by a self-closing anastomotic clip, yielded 6-month follow-up and angiographic results that compared favorably with results of other published studies.