5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes: MITRAL Trial Final Results.

BACKGROUND: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective trial to evaluate the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with failed surgical bioprostheses or annuloplasty rings and severe mitral annular calcification treated with mitral valve-in-valve (MViV), valve-in-ring (MViR), or valve-in-mitral annular calcification (ViMAC). OBJECTIVES: The aim of this study was to evaluate 5-year outcomes among these patients. METHODS: A multicenter prospective study was conducted among patients at high surgical risk at 13 U.S. sites. Patients underwent MViV (n = 30), MViR (n = 30), or ViMAC (n = 31) and were followed annually for 5 years. Kansas City Cardiomyopathy Questionnaire scores were obtained at baseline and follow-up visits. Echocardiograms were analyzed at independent core laboratories. RESULTS: A total of 91 patients underwent transcatheter mitral valve replacement (February 2015 to December 2017). The mean age was 74.3 ± 8.9 years. At 5-year follow-up, the lowest all-cause mortality was observed in the MViV group (21.4%), 94.7% of patients were in NYHA functional class I or II, and the mean mitral gradient was 6.6 ± 2.5 mm Hg. The MViR and ViMAC groups had higher all-cause mortality (65.5% and 67.9%), most survivors were in NYHA functional classes I and II (50% and 55.6%), and mean mitral gradients remained stable (5.8 ± 0.1 and 6.7 ± 2.5 mm Hg). Significant improvements in Kansas City Cardiomyopathy Questionnaire scores were observed when all 3 arms were pooled. CONCLUSIONS: MViV, MViR, and ViMAC procedures were associated with sustained improvement of heart failure symptoms and quality of life among survivors at 5 years. Transcatheter heart valve function remained stable in all 3 groups. Patients treated with MViV had excellent survival at 5 years, whereas survival was lower in the MViR and ViMAC groups, consistent with underlying disease severity. Patients with more residual mitral regurgitation had higher mortality.

2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Annular Calcification, Rings, and Bioprostheses.

BACKGROUND: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective study for valve-in-mitral annular calcification (ViMAC), mitral valve-in-ring (MViR), and mitral valve-in-valve (MViV) using balloon-expandable aortic transcatheter heart valves. Procedural outcomes beyond 1 year are not well described. OBJECTIVES: This study evaluated 2-year outcomes in ViMAC, MViR, and MViV in the MITRAL trial. METHODS: This multicenter prospective study enrolled patients with severe MAC, prior failed mitral annuloplasty ring repair, or prior failed bioprosthetic MV replacement who were at high surgical risk at 13 U.S. sites. RESULTS: Between February 1, 2015, and December 31, 2017, 91 patients were enrolled (31 with ViMAC, 30 with MViR, and 30 with MViV). In the ViMAC group, 2-year all-cause mortality was 39.3%, 66.7% were New York Heart Association (NYHA) functional class I-II, and mean MV gradient was 5.6 ± 2.0 mm Hg. In the MViR group, 2-year all-cause mortality was 50%, 65% were NYHA functional class I-II, and mean MV gradient was 6.5 ± 2.7 mm Hg. In the MViV group, 2-year all-cause mortality was 6.7%, 85% were NYHA functional class I-II, and mean MV gradient was 6.9 ± 2.4 mm Hg. At 2 years, all patients had ≤mild mitral regurgitation and survivors in all 3 arms showed sustained improvement in Kansas City Cardiomyopathy Questionnaire scores compared to baseline. CONCLUSIONS: Use of balloon-expandable aortic transcatheter heart valves in selected patients with severe MAC, failed annuloplasty ring, and bioprosthetic MV dysfunction is associated with improvements in symptoms, quality of life, and stable prosthesis function at 2-year follow-up. Between 1 and 2 years, the MViR group experienced higher mortality rates than the MViV and ViMAC groups.

Massive Device-Related Thrombus After LAA Occlusion: Intraoperative Insights Into Mechanism.

In patients with a contraindication to oral anticoagulation, the left atrial appendage occlusion devices are an approved alternative. Device-related thrombus is a recognized complication, but underlying mechanisms are incompletely understood. In this case series, the authors describe potentially the same mechanism of thrombosis with intraoperative images of incomplete endothelialization. (Level of Difficulty: Intermediate.).

Percutaneous Paravalvular Leak Repair.

Paravalvular leaks (PVLs) are challenging lesions that require a comprehensive understanding of surgical and transcatheter heart therapies, multimodality imaging, and transcatheter techniques. Approach to a transcatheter heart valve (THV) or surgical prosthesis for PVL differs in terms of options and varies according to the location (aortic or mitral). A suggested framework for transcatheter PVL repair is defect localization, access planning, defect crossing, sheath delivery. and occluder deployment. Careful planning facilitates success, but operators begin the case with a flexible mindset because many initial strategies may not succeed.

Transcatheter Tricuspid Valve Replacement for Surgical Failures.

Tricuspid valve surgery has high mortality for first-time operations and repeat surgery is fraught with even higher rates. When failed tricuspid surgical prostheses and repairs are present, physicians look toward transcatheter tricuspid valve replacement (TTVR) as a tangible solution. Using balloon-expandable bioprosthetic valves in an off-label fashion, tricuspid valve-in-valve (TViV) procedures can be performed reliably; however, valve-in-ring cases are more nuanced and have higher risks of paravalvular leak and valve malpositioning. TTVR specific issues include THV anchoring, management of preexisting pacing leads, postprocedure thromboembolic prophylaxis, and possible tricuspid reintervention.

Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes.

OBJECTIVES: The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. BACKGROUND: The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses. METHODS: High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year). RESULTS: Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+. CONCLUSIONS: Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year.

Thirty-Day Outcomes of Transcatheter Mitral Valve Replacement for Degenerated Mitral Bioprostheses (Valve-in-Valve), Failed Surgical Rings (Valve-in-Ring), and Native Valve With Severe Mitral Annular Calcification (Valve-in-Mitral Annular Calcification) in the United States: Data From the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry.

BACKGROUND: Transcatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical repairs with annuloplasty rings or severe mitral annular calcification who are poor surgical candidates. Outcomes of these procedures are collected in the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry. A comprehensive analysis of mitral valve-in-valve (MViV), mitral valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) outcomes has not been performed. We sought to evaluate short-term outcomes of early experience with MViV, MViR, and ViMAC in the United States. METHODS: Retrospective analysis of data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. RESULTS: Nine hundred three high-risk patients (median Society of Thoracic Surgeons score 10%) underwent MViV (n=680), MViR (n=123), or ViMAC (n=100) between March 2013 and June 2017 at 172 hospitals. Median age was 75 years, 59.2% female. Technical and procedural success were higher in MViV. Left ventricular outflow tract obstruction occurred more frequently with ViMAC (ViMAC=10%, MViR=4.9%, MViV=0.7%; P<0.001). In-hospital mortality (MViV=6.3%, MViR=9%, ViMAC=18%; P=0.004) and 30-day mortality (MViV=8.1%, MViR=11.5%, ViMAC=21.8%; P=0.003) were higher in ViMAC. At 30-day follow-up, median mean mitral valve gradient was 7 mm Hg, most patients (96.7%) had mitral regurgitation grade ≤1 (+) and were in New York Heart Association class I to II (81.7%). CONCLUSIONS: MViV using aortic balloon-expandable transcatheter heart valves is associated with a low complication rate, a 30-day mortality lower than predicted by the Society of Thoracic Surgeons score, and superior short-term outcomes than MViR and ViMAC. At 30 days, patients in all groups experienced improvement of symptoms, and valve performance remained stable. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02245763.

Left atrial hemodynamics and left ventricular remodeling -predictors of outcomes after Transcatheter mitral valve repair with the MitraClip device.

BACKGROUND: Increased afterload and reduced left ventricular (LV) performance are sequela of mitral valve repair. However, hemodynamic left atrial and ventricular parameters that can predict outcome following mitral valve repair remain elusive. METHODS: One hundred and two consecutive patients undergoing MitraClip procedure from 2014 to 2017 at Banner University Medical Center were enrolled in this study. All patients underwent pre-procedure echocardiograms and intra-procedure invasive left atrial (LA) pressure monitoring. Clinical, laboratory, and procedural parameters were collected. The primary end-point was the composite outcome of all-cause mortality and repeat hospitalization within 90 days. RESULTS: The mean age was 77 ±10 years, the majority were Caucasians (93, 91.2%) and 47 (46.1%) were males. Thirty-two patients (31.4%) had diabetes, 39 (38.2%) had renal insufficiency, and 38 (37.3%) had a history of congestive heart failure. The median society of thoracic surgeons score was 6.7% (Interquartile range [IQR]: 3.9, 10.2). Immediately post-procedure there was a significant reduction in the LA pressure (Mean 12.0 vs. 18.6 mmHg, P < 0.001) and pulmonary artery systolic pressure (43.5 vs. 53.2 mmHg, P = 0.001) compared to baseline. LA pressure was an independent predictor of the composite outcome in an unadjusted (OR = 1.07, 95% CI: 1.00-1.13, P = 0.03) and adjusted (OR = 1.07, 95% CI: 1.00-1.14, P = 0.03) analysis respectively. CONCLUSION: LA pressure drop is an independent predictor of outcome after the MitraClip procedure. This finding has implications for early identification of patients at risk of poor outcomes and instituting aggressive medical therapy and close follow-up for avoiding hospitalizations for heart failure decompensation.

Permanent pacemaker implantation and paravalvular leak rates following sutureless aortic valve operations.

BACKGROUND: Permanent pacemaker (PPM) implantation and paravalvular leak (PVL) rates after sutureless aortic valve replacement (SuAVR) vary widely. The aim of this meta-analysis was to examine the incidence of new PPM implantation and PVL after SuAVR. METHODS: Studies evaluating PPM implantation and PVL rates after SuAVR were searched in Medline/PubMed, Ovid Journals, Clinicaltrials.gov, Cochrane central register of controlled trials and database. Studies with a sample size ≥10 were included in this analysis. Pooled proportions were calculated using both the fixed and random-effects models. The heterogeneity among studies was tested using I2 statistic. The study design was written in accordance with PRISMA guidelines. RESULTS: Thirty studies involving 3993 patients with a median follow-up of 12 months were included. The median age was 77 years and males constituted 50%. There was a history of stroke and coronary artery disease in 6% and 31% of the population. Pooled proportions demonstrate a cumulative postoperative PPM rate of 8.5% (95% confidence interval [CI] 7.6-9.5%, I2 = 68.8%) and the overall rate of any PVL was 4.2% (95%CI 3.4-5%, I2 = 76.1%) across all major SuAVR devices. The rate of severe PVL was only 0.4% (95%CI 0.2-0.7%, I2 = 0%) at discharge and 0.5% (95%CI 0.2-0.9%, I2 = 0%) at 12 months. CONCLUSIONS: In SuAVR prostheses implanted in this meta-analysis, the postoperative permanent pacemaker rate was higher (8.5%) than reported for non-SuAVR prosthesis. While the overall PVL rate was 4.2%, the incidence of severe PVL was only 0.4% at discharge and remained stable at 0.5% at 12 months.

Double Trouble: Transapical Transcatheter Replacement of the Aortic and Mitral Valves in a Single Operation.

This case represents the first reported simultaneous TAVR and TMVR for native aortic and mitral stenosis performed via the transapical approach.

Impact of aortic aneurysms in trans-catheter aortic valve replacement: A single center experience.

BACKGROUND: Patients who undergo trans-catheter aortic valve replacement (TAVR) may have concomitant aortic aneurysms. We sought to clarify the incidence of aortic aneurysms and its impact on clinical outcomes among patients undergoing TAVR. METHODS: We performed a retrospective analysis of patients with severe symptomatic aortic stenosis who underwent TAVR from January 2012 to June 2016. Multi-detector computer tomography (MDCT) was performed on all patients and images were reviewed to identify thoracic and abdominal aortic aneurysms (TAA and AAA). The incidence of vascular complications (VARC-2 definition), and in-hospital and 6-month major adverse cardiac events (MACE) defined as a composite of all-cause mortality, cardiac arrest, myocardial infarction, and stroke were recorded. RESULTS: Among 232 patients included in the analysis, 22 patients (9.5%) had aortic aneurysms (11 had AAA, 8 had TAA, and 3 had both). Patients with aortic aneurysms had a higher, albeit statistically insignificant, rate of smoking history (63.6% vs. 42.9%, p = 0.062). Both groups of patient predominantly underwent TAVR via trans-femoral access (72.7% vs. 71.4%, p = 0.90). The incidence of vascular complications was similar between the two groups (9.1% vs. 10.5%, p = 1.0). Patients with aortic aneurysms had a similar in-hospital MACE (4.5% vs. 6.2%, p = 1.0) and 6-month MACE (9.1% vs. 9.0%, p = 1.0) compared to those without aneurysms. CONCLUSIONS: In our patient cohort, 9.5% of patients who underwent TAVR had concomitant aortic aneurysms. Patients with aortic aneurysms had similar incidence of vascular complications as well as in-hospital and 6-month MACE compared to those without.

Volume-outcome relationships for transcatheter aortic valve replacement-risk-adjusted and volume stratified analysis of TAVR outcomes.

OBJECTIVES: This purpose of the study was to evaluate TAVR outcomes at low, intermediate and high volume institutions. BACKGROUND: For the care of complex patients, volume-outcome effect is well described. The initial US TAVR experience was limited to a few centers of excellence. The impact of institutional volume on outcomes after TAVR has not been systematically studied. METHODS: Within the Banner Health system, TAVR is performed at 3 institutions-a low volume, an intermediate volume and a high volume institution. 181 consecutive patients undergoing TAVR within these 3 institutions were the study cohort. To adjust for bias and confounders between the 3 groups, risk-adjusted multivariate logistic regression and propensity score analysis was performed. The primary endpoint was a composite of mortality, dialysis-dependent renal failure, cerebrovascular accident, need for new permanent pacemaker and readmission within 30days. RESULTS: The primary endpoint was reached in 38.8% of patients at the high volume institution and 76.2% of patients at the low volume institution (p<0.01). Having a TAVR procedure at a larger volume institution was an independent predictor of having improved outcomes (OR 0.33, 95% CI 0.16-0.68; p=0.003). These improved outcomes after the TAVR procedure noted at the large volume institution were seen in the most complex patients: age ≥80years, BMI >30, diabetes, hypertension, prior CAD, CKD and NYHA class III/IV heart failure. CONCLUSIONS: High-risk patients undergoing TAVR at a large volume institution have better 30-day outcomes compared to outcomes at intermediate and low volume centers.

Impact of institutional volume and experience with CT interpretation on sizing of transcatheter aortic valves: A multicenter retrospective study.

BACKGROUND: Computed tomography (CT) has become the standard imaging modality for pre-procedural aortic annular sizing prior to transcatheter aortic valve replacement (TAVR). We hypothesized that the accuracy of CT derived annular measurements would be greater at sites with higher TAVR procedural volume. METHODS: Within a large integrated health system, TAVR was performed at low (<40 cases), intermediate (40-75 cases), and high-volume sites (>75 cases). 181 patients underwent TAVR with a Sapien XT transcatheter heart valve (THV). Two blinded experienced readers independently remeasured the annulus on CT and compared their measurements to site reported measurements. Hypothetical THV sizes were chosen based on measurements from site CT reports and independent readers' measurements, and compared to the implanted THV size. RESULTS: Correlation between site reported measurements and independent readers measurements of mean annulus size varied between low-volume (r=0.31, p=0.18), intermediate-volume (r=0.34, p=0.01), and high-volume sites (r=0.96, p<0.01). On multivariate analysis, interpretation of ≥20 CT scans (OR 0.29; 95% CI 0.03-0.81; p 0.02) and high-volume site (OR 0.16; 95% CI 0.10-0.82; p 0.02) were associated with reduced mismatch between the site predicted THV size and independent readers predicted THV size. Mismatch between site predicted THV size and implanted THV size was associated with a worse 30-day composite of mortality, dialysis-dependent renal failure, cerebrovascular accident, new permanent pacemaker, and hospital readmission (55.3 vs. 38.7%; p=0.05). CONCLUSIONS: Accuracy of CT aortic annular sizing is improved with higher individual experience and site TAVR volume. These findings should be confirmed in larger, prospective studies.

Aortic annulus measurement and relevance to successful transcatheter aortic valve replacement: a new technique using 3D TEE.

BACKGROUND: There are limitations of using 2D imaging to accurately size the aortic annulus. This article highlights the limitations of 2D technology and proposes a new 3D TEE method for sizing of the aortic annulus. METHODS: Three-dimensional echocardiography with the method described can identify the "true" aortic annulus with precision. A 3D dataset of the aortic annulus is collected. The 3D quantification program is then activated. The three multiplanar reconstruction planes (the aortic short-axis, long-axis, and coronal planes) are aligned during systole, to obtain the 3 nadirs of the sinuses of Valsalva simultaneously in the short-axis MPR. Rotating the sagittal and coronal planes to identify the hinge points is necessary to measure the diameter of the "true" annulus. The "true" aortic annulus is defined by the blood-tissue interface in the aortic short-axis MPR. RESULTS: This method has been prospectively validated with surgical AVR sizing in a small study of 10 patients. During surgical AVR, the annulus was directly measured using a sizer. This served as a gold standard for comparison. The annulus was measured using the method described in a blinded fashion by the cardiac anesthesiologist and then confirmed offline by a blinded echocardiographer. In this small study, the Pearson correlation coefficient was 0.9833 with 23.4 and 23.22 mm being the mean measurements with the 2 methods. DISCUSSION: The method described in this article is complementary to multidetector computed tomography and provides a real-time measurement of the annulus during the TAVR procedure without need for radiographic contrast.