First North American experience with the transfemoral ACURATE-neoTM self-expanding transcatheter aortic bioprosthesis.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become a therapeutic alternative for patients presenting with severe symptomatic aortic stenosis and considered at high-surgical risk. Paravalvular leak (PVL), conduction disorders, and coronary obstruction remain unresolved procedure-related complications. The aim of this manuscript was to report the first North American experience with the ACURATE-neoTM aortic bioprosthesis and its ACURATE-TFTM delivery system (Symetis S.A., Ecublens, Switzerland). METHODS: Transfemoral ACURATE-neoTM aortic valve implantation was performed in 20 patients. Clinical and echocardiographic assessment was performed at baseline, postprocedure and at least 30 days. Outcomes were assessed according to valvular academic research consortium (VARC-2) criteria. RESULTS: The mean age was 82.7 ± 7.0 years with a mean logistic-EuroSCORE-II of 5.0 ± 2.9% and Society of Thoracic Surgeons score of 4.7 ± 2.3%. Device success was achieved in all patients. The mean distance between the aortic-annulus and the left main coronary artery ostium was 14.3 ± 3.2 mm, and eight (40%) patients had <12 mm. At 30 days, there were no deaths, conversions to surgery, or major procedure-related complications. New-pacemaker implantation was required in one (5.3%) patient. ACURATE-neoTM implantation resulted in a significant reduction in mean transvalvular gradient (49.9 ± 15.8 to 9.7 ± 5.7 mm Hg, P < 0.0001) and increase in effective-orifice area (0.65 ± 0.16 to 1.83 ± 0.36 cm2 , P = 0.001) at hospital discharge. Paravalvular leak was absent in four (20%) patients, trace in nine (45%) patients, and mild in seven (35%) patients. Hospital discharge occurred at a mean of 7.0 ± 4.5 days, and all patients were in NYHA class I-II at a mean follow-up of 8.6 ± 2.3 months. CONCLUSION: The present initial North American experience shows that the ACURATE-neoTM aortic bioprosthesis was safely and successfully implanted by transfemoral approach. The special design of this newer-generation device affords a stable and predictable implantation, while providing optimal hemodynamic performance with a relatively low rate of PPI. © 2016 Wiley Periodicals, Inc.

Ultrafast Track Robotic-Assisted Minimally Invasive Coronary Artery Surgical Revascularization.

OBJECTIVE: Contemporary anesthetic techniques have enabled shorter sedation and early extubation in off-pump and minimally invasive coronary artery bypass (CABG) surgery. Robotic-assisted CABG represents the optimal surgical approach for ultrafast track anesthesia, with patients able to bypass the cardiac surgical intensive care unit with recovery in the postanesthesia care unit (PACU) and inpatient ward. METHODS: In-hospital postoperative outcomes from ninety patients who underwent either elective or urgent robotically-assisted CABG at our institution were reviewed. These patients were carefully selected by a multidisciplinary team to undergo fast-track anesthesia: extubation in the operating room, 4-hour recovery in the postanesthesia care unit and transfer to the inpatient ward. Intrathecal, paravertebral local, and patient-controlled anesthesia techniques were used to facilitate transition to oral analgesics. RESULTS: Average patient age was 61 ± 9 years. Sixty-six patients (73%) were male. Seventy cases were elective, and 20 patients required urgent revascularization. All patients underwent intraoperative angiography after graft construction, which revealed Fitzgibbon class A grafts. There were no in-hospital mortalities. One patient required re-exploration for bleeding, through the same minimally invasive incision, did not require conversion to sternotomy for bleeding, and was transferred to the intensive care unit postexploration for bleeding for standard postoperative care. Postoperative complications were limited to one superficial wound infection. The mean hospital length of stay was 3.5 ± 1.17 days. CONCLUSIONS: In patients undergoing robotic-assisted CABG, ultrafast-track cardiac surgery with immediate postprocedure extubation and transfer to the inpatient ward has been demonstrated to be safe with no increase in perioperative morbidity or mortality. It requires a dedicated heart team with a carefully selected group of patients. Avoiding cardiac surgical intensive care unit expedites recovery, with possible avoidance of infection and early discharge from hospital.

First North American Experience With the Engager Self-Expanding Transcatheter Aortic Valve: Insights From the London Health Sciences Centre Heart Team.

The Engager aortic bioprosthesis consists of bovine pericardial leaflets mounted on a self-expandable frame with unique anatomic orientation capabilities to engage the aortic valve cusps. We report the initial North American transcatheter aortic valve implantation (TAVI) experience with the Engager device. Transapical TAVI was performed in 4 patients (mean age 80 ± 6 years, Society of Thoracic Surgeons score 5 ± 1%). The valve was anatomically oriented and successfully implanted in all patients. There were no conversions to open operation or major procedure-related adverse events. Pacemaker implantation was necessary in 1 patient. None of the patients showed paravalvular leak. The Engager device for TAVI provides anatomic orientation and anchoring that prevents coronary obstruction and paravalvular leak.

Transcatheter Aortic Valve Implantation With or Without Preimplantation Balloon Aortic Valvuloplasty: A Systematic Review and Meta-Analysis.

BACKGROUND: Preimplantation balloon aortic valvuloplasty (BAV) is considered a routine procedure during transcatheter aortic valve implantation (TAVI) to facilitate prosthesis implantation and expansion; however, it has been speculated that fewer embolic events and/or less hemodynamic instability may occur if TAVI is performed without preimplantation BAV. The aim of this study was to systematically review the clinical outcomes associated with TAVI undertaken without preimplantation BAV. METHODS AND RESULTS: We conducted a search of Medline and Embase to identify studies that evaluated patients who underwent TAVI with or without preimplantation BAV for predilation. Pooled analysis and random-effects meta-analyses were used to estimate the rate and risk of adverse outcomes. Sixteen studies involving 1395 patients (674 with and 721 without preimplantation BAV) fulfilled the inclusion criteria. Crude device success was achieved in 94% (1311 of 1395), and 30-day all-cause mortality occurred in 6% (72 of 1282) of patients. Meta-analyses evaluating outcomes of strategies with and without preimplantation BAV showed no statistically significant differences in terms of mortality (relative risk [RR] 0.61, 95% CI 0.32-1.14, P=0.12), safety composite end point (RR 0.85, 95% CI 0.62-1.18, P=0.34), moderate to severe paravalvular leaks (RR 0.68, 95% CI 0.23-1.99, P=0.48), need for postdilation (RR 0.86, 95% CI 0.66-1.13, P=0.58), stroke and/or transient ischemic attack (RR 0.72, 95% CI 0.30-1.71, P=0.45), and permanent pacemaker implantation (RR 0.80, 95% CI 0.49-1.30, P=0.37). CONCLUSIONS: Our analysis suggests that TAVI procedures with or without preimplantation BAV were associated with similar outcomes for a number of clinically relevant end points. Further studies including a large number of patients are needed to ascertain the impact of TAVI without preimplantation BAV as a standard practice.

Sealing Intermediate Nonobstructive Coronary Saphenous Vein Graft Lesions With Drug-Eluting Stents as a New Approach to Reducing Cardiac Events: A Randomized Controlled Trial.

BACKGROUND: The objective of this study was to assess the efficacy of sealing intermediate nonobstructive coronary saphenous vein graft (SVG) lesions with drug-eluting stents (DES; paclitaxel- or everolimus-eluting stents) for reducing major adverse cardiac events (MACE). METHODS AND RESULTS: This was a randomized controlled multicenter clinical trial that enrolled patients with a previous coronary artery bypass graft who had developed at least 1 intermediate nonobstructive SVG lesion (30%-60% diameter stenosis by visual estimation). Patients were randomized (1:1) to DES implantation (SVG-DES) or medical treatment (SVG-MT) of the target SVG lesion. The primary efficacy outcome was the first occurrence of MACE defined as the composite of cardiac death, myocardial infarction, or coronary revascularization related to the target SVG during the duration of follow-up (minimum of 2 years). Secondary efficacy outcomes included MACE related to the target SVG lesion and overall MACE. A total of 125 patients (mean age 70±9 years, 87% men) were included, with a mean time from coronary artery bypass graft of 12±5 years. Sixty and 65 patients were allocated to the SVG-DES and SVG-MT groups, respectively. There were no events related to the target SVG at 30 days. After a median follow-up of 3.4 (interquartile range: 2.8-3.9) years, the MACE rate related to the target SVG was not significantly different in the 2 groups (SVG-DES: 15.0%, SVG-MT: 20.0%; hazard ratio, 0.65; 95% confidence interval, 0.23-1.53; P=0.33). There were no significant differences between groups in MACE related to the target SVG lesion (SVG-DES: 10.0%, SVG-MT: 16.9%; hazard ratio, 0.53; 95% confidence interval, 0.20-1.43; P=0.21) or global MACE (SVG-DES: 36.7%, SVG-MT: 44.6%; hazard ratio, 0.73; 95% confidence interval, 0.42-1.27; P=0.26). CONCLUSIONS: Sealing intermediate nonobstructive SVG lesions with DES was safe but was not associated with a significant reduction of cardiac events at 3-year follow-up. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01223443.

Transcatheter ACURATE-TA Aortic Valve Implantation in a Patient With a Previous Mechanical Mitral Valve.

Transcatheter aortic valve implantation (TAVI) in the presence of a mechanical mitral valve (MMV) prosthesis is still challenging because of the rigid mitral frame within the aortomitral curtain. Moreover, low-lying coronary ostia represent a hazardous problem of coronary obstruction, especially in narrow or porcelain aortic roots. The present case demonstrates the successful management of 2 challenging anatomical issues, the rigid cage of the MMV and the low-lying left main coronary ostium (LMCO), with the implantation of the ACURATE-TA bioprosthesis (Symetis SA, Ecublens, Switzerland). It also highlights the importance of having multiple TAVI devices in order to choose the ideal transcatheter aortic bioprosthesis to fit the unique anatomical presentation of the patient.