Faculty Bibliography

OBJECTIVES/OBJECTIVE:This study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis. BACKGROUND:A next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve. METHODS:The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. The 2 primary safety endpoints were the incidence of all-cause mortality at 30 days and the incidence of disabling stroke at 30 days. The primary efficacy endpoint was the proportion of patients with no or trace prosthetic valve regurgitation at 30 days. An independent echocardiographic core laboratory (Mayo Clinic, Rochester, Minnesota) was used to adjudicate all echocardiographic assessments. RESULTS:All 60 patients received the Evolut PRO valve. At 30 days, 1 patient (1.7%) died and 1 patient (1.7%) experienced a nonfatal disabling stroke. Paravalvular regurgitation at 30 days was absent or trace in 72.4% of patients and was mild in the remainder of patients, with no patients having worse than mild paravavlular leak. The mean atrioventricular gradient was 6.4 ± 2.1 mm Hg and effective orifice area was 2.0 ± 0.5 cm2 at 30 days. CONCLUSIONS:The safety and efficacy results of this study support the use of the Evolut PRO System for the treatment of severe symptomatic aortic stenosis in patients who are at increased surgical risk, resulting in excellent hemodynamics and minimal paravalvular leak (The Medtronic TAVR 2.0 US Clinical Study; NCT02738853).

OBJECTIVES/OBJECTIVE:The purpose of this study was to identify sex-specific outcomes of intermediate risk patients undergoing transcatheter aortic valve replacement with the SAPIEN 3 valve. BACKGROUND:A survival difference has been observed in women as compared with men in inoperable and high-risk patients receiving early-generation balloon-expandable valves for transcatheter aortic valve replacement (TAVR). Whether a sex-specific outcome difference persists with newer-generation valves and in lower-risk patients is unknown. METHODS:The PARTNER (Placement of Aortic Transcatheter Valves) II S3 trial included high-risk (HR) (Society of Thoracic Surgeons risk score >8% or heart team determination) and intermediate-risk (IR) (Society of Thoracic Surgeons risk score 4% to 8% or heart team determination) patients with severe symptomatic aortic stenosis who were treated with TAVR with the SAPIEN 3 valve. Patient characteristics and clinical outcomes at 30 days and 1 year were compared by sex. RESULTS:Between October 2013 and December 2014, 1,661 patients were enrolled: 583 were HR (338 men, 245 women) and 1,078 were IR (666 men, 412 women). In both cohorts, women were more likely than men to be frail (22% vs. 13%; p < 0.001), but less likely to have comorbid conditions of renal insufficiency, coronary artery disease, atrial fibrillation, or chronic obstructive pulmonary disease. Women were more likely to receive ≤23-mm valves (74.1% vs. 11.1%; p < 0.001) and were less likely to receive 29-mm valves (1.4% vs. 35.1%; p < 0.001). In the combined cohorts, there was no difference in mortality for women compared with men at 30 days (2.0% vs. 1.2%; p = 0.20) or 1 year (9.3% vs. 10.2%; p = 0.59). There were no differences in disabling stroke or any stroke at 30 days or 1 year; however, women had an increased rate of minor stroke at 30 days (2.1% vs. 0.7%; p = 0.01). Female sex was associated with increased major vascular complications (7.9% vs. 4.4%; p = 0.003), but not with moderate or severe paravalvular regurgitation. Notably, similar outcomes regarding sex-specific outcomes were obtained within stratified analyses of the HR and IR cohorts. CONCLUSIONS:The study found no apparent sex-specific differences in survival or stroke in this trial of TAVR. This may reflect the changing demographic of patients enrolled, use of newer-generation valves with more sizes available, and more accurate valve sizing techniques.

BACKGROUND:The PARTNER-2A randomized trial compared outcomes of transfemoral transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in intermediate-risk patients with severe aortic stenosis. The purpose of the current study was to perform an in-depth analysis of outcomes after SAVR in PARTNER-2A. METHODS:From 1/2012-1/2014, 937 patients underwent SAVR at 57 centers. Mean age was 82±6.7 and 55% were men. Less-invasive operations were performed in 140 (15%) and concomitant procedures in 198 (21%). Major outcomes and echocardiograms were adjudicated by an independent events committee. Follow-up was 94% complete to 2 years. RESULTS:Operative mortality was 4.1% (n=38, STS PROM 5.2±2.3%), O/E 0.8, and in-hospital stroke 5.4% (n=51), twice expected. Aortic clamp and bypass times were 75±30 and 104±46 minutes. Patients having severe prosthesis-patient mismatch (n=260, 33%) had similar survival to those without (P>.9), as did those undergoing less-invasive SAVR (P=.3). Risk factors for death included cachexia (P=.004), tricuspid regurgitation (P=.01), coronary artery disease (P=.02), preoperative atrial fibrillation (P=.001), higher white cell count (P<.0001), and lower hemoglobin (P=.0002). CONCLUSIONS:In this adjudicated prospective study, SAVR in intermediate-risk patients had excellent results at 2 years. However, there were more in-hospital strokes than expected, most likely attributable to mandatory neurologic assessment post-procedure. There was no significant structural valve deterioration during 2-year follow-up. Continued long-term surveillance remains important.

Objective: The longer dosing interval afforded by Del Nido cardioplegia (DNC) may simplify myocardial protection strategies. We analyzed the impact and safety of DNC in patients undergoing minimally invasive aortic valve replacement. Methods: Institutional use of DNC began in May 2013; we analyzed all isolated minimally invasive aortic valve replacements during this transition (May 2013-June 2015), excluding reoperative sternotomy patients. The approach was hemi-median sternotomy in all patients. Prospectively collected local and Society of Thoracic Surgeons database data were used. Patients were divided into 2 cohorts: those who received 4:1 crystalloid:blood DNC solution and those in whom standard 1:4 Buckberg-based cardioplegia (BC) was used. One-to-one propensity case matching of DNC to Buckberg-based cardioplegia was performed based on standard risk factors, and differences between groups were analyzed using X² and nonparametric methods. Results: Minimally invasive aortic valve replacement was performed in 181 patients; DNC was usedin 59 and Buckberg-based cardioplegia in 122. Case matching resulted in 59 patients per cohort. DNC was associated with reduced re-dosing [5/59 (8.5%) vs. 39/59 (61.0%), P<0.001] and less total cardioplegia volume (1290 ml+/-347 ml vs. 2284 ml+/-828 ml, P<0.001). Antegrade cardioplegia alone was used in 89.8% (53/59) of DNC patients versus 33.9% (20/59) of patients receiving Buckberg-based cardioplegia (P<0.001). Median bypass and aortic cross-clamp times were similar. Clinical outcomes were similar with respect to postoperative hematocrit, transfusion requirements, need for inotropic/pressor support, duration of stay in the intensive care unit, re-intubation, length of hospital stay, new onset atrial fibrillation, and mortality rate. Table SA15-1 contains demographics, cardioplegia delivery methods, and results. Conclusions: DNC usage markedly simplifies cardioplegia strategy for minimally invasive aortic valve replacement. Patient safety was not compromised with this technique. (Table pasented)

The technique of mechanical circulatory support or the site of cannulation may affect transvalvular flow. We describe early failure of a mitral bioprosthesis in a patient with temporary left ventricular assist device support, likely from thrombosis. Salvage with transcatheter mitral valve replacement was attempted. Temporary mechanical circulatory support strategies that maximize flow across a new bioprosthesis should be sought to avoid early valvular thrombosis.

Atrial fibrillation (AF) is associated with worse outcomes in many cardiovascular diseases. There are few data examining pacemaker implantation rates and indications in patients with AF who undergo transcatheter aortic valve replacement (TAVR). To examine the impact of AF on the incidence of and indications for pacemakers in patients undergoing TAVR, we evaluated data of 1723 patients without pre-existing pacemakers who underwent TAVR in the Placement of AoRTic TraNscathetER Valve (PARTNER) trial. Permanent pacemaker implantation rates and indications were compared in groups based on baseline and discharge heart rhythm: sinus rhythm (SR) vs. AF. 1211 patients manifested SR at baseline/SR at discharge (SR/SR), 105 SR baseline/AF discharge (SR/AF), and 407 AF baseline/AF discharge (AF/AF). Patients who developed and were discharged with AF (SR/AF) had the highest rates of pacemaker implantation at 30 days (13.7% SR/AF vs. 5.4% SR/SR, p=0.0008 and 5.9% AF/AF, p=0.008) and 1 year (17.7% SR/AF vs. 7.1% SR/SR, p=0.0002 and 8.1% AF/AF, p=0.0034). Conversion from SR to AF by discharge was an independent predictor of increased pacemaker implantation at 30 days (HR 2.19 vs. SR/SR, 95% CI 1.23-3.93, p=0.008) and 1 year (HR 1.91 vs. SR/SR, 95% CI 1.33-3.80). Pacemaker indications differed between groups, with relatively more implanted in the AF groups for sick sinus syndrome (SSS) versus AV block. In conclusion, conversion to AF is an independent predictor of permanent pacemaker implantation in TAVR patients. Indications differ depending on heart rhythm, with patients in AF manifesting clinically significant tachy-brady syndrome versus AV block.