Contemporary experience of mitral transcatheter edge-to-edge repair technology in patients with mitral annular calcification.

BACKGROUND: Mitral annular calcification (MAC) has been an exclusion for many of the earlier pivotal trials that were instrumental in gaining device approval and indications for mitral transcatheter edge-to-edge repair (M-TEER). AIMS: To evaluate the impact of MAC on the procedural durability and success of newer generation MitraClip® systems (G3 and G4 systems). METHODS: Data were collected from Northwell TEER registry. Patients that underwent M-TEER with third or fourth generation MitraClip device were included. Patients were divided into -MAC (none-mild) and +MAC (moderate-severe) groups. Procedural success was defined as ≤ grade 2 + mitral regurgitation (MR) postprocedure, and durability was defined as ≤ grade 2 + MR retention at 1 month and 1 year. Univariate analysis compared outcomes between groups. RESULTS: Of 260 M-TEER patients, 160 were -MAC and 100 were +MAC. Procedural success was comparable; however, there were three patients who required conversion to cardiac surgery during the index hospitalization in the +MAC group versus none in the -MAC group (though this was not statistically significant). At 1-month follow-up, there were no significant differences in MR severity. At 1-year follow-up, +MAC had higher moderate-severe MR (22.1% vs. 7.5%; p = 0.002) and higher mean transmitral gradients (5.3 vs. 4.0 mmHg; p = 0.001) with no differences in mortality, New York Heart Association functional class or ejection fraction. CONCLUSION: In selective patients with high burden of MAC, contemporary M-TEER is safe, and procedural success is similar to patients with none-mild MAC. However, a loss of procedural durability was seen in +MAC group at 1-year follow-up. Further studies with longer follow-ups are required to assess newer mTEER devices and their potential clinical implications in patients with a high burden of MAC.

Explant vs Redo-TAVR After Transcatheter Valve Failure: Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry.

BACKGROUND: Valve reintervention after transcatheter aortic valve replacement (TAVR) failure has not been studied in detail. OBJECTIVES: The authors sought to determine outcomes of TAVR surgical explantation (TAVR-explant) vs redo-TAVR because they are largely unknown. METHODS: From May 2009 to February 2022, 396 patients in the international EXPLANTORREDO-TAVR registry underwent TAVR-explant (181, 46.4%) or redo-TAVR (215, 54.3%) for transcatheter heart valve (THV) failure during a separate admission from the initial TAVR. Outcomes were reported at 30 days and 1 year. RESULTS: The incidence of reintervention after THV failure was 0.59% with increasing volume during the study period. Median time from index-TAVR to reintervention was shorter in TAVR-explant vs redo-TAVR (17.6 months [IQR: 5.0-40.7 months] vs 45.7 months [IQR: 10.6-75.6 months]; P < 0.001], respectively. TAVR-explant had more prosthesis-patient mismatch (17.1% vs 0.5%; P < 0.001) as the indication for reintervention, whereas redo-TAVR had more structural valve degeneration (63.7% vs 51.9%; P = 0.023), with a similar incidence of ≥moderate paravalvular leak between groups (28.7% vs 32.8% in redo-TAVR; P = 0.44). There was a similar proportion of balloon-expandable THV failures (39.8% TAVR-explant vs 40.5% redo-TAVR; P = 0.92). Median follow-up was 11.3 (IQR: 1.6-27.1 months) after reintervention. Compared with redo-TAVR, TAVR-explant had higher mortality at 30 days (13.6% vs 3.4%; P < 0.001) and 1 year (32.4% vs 15.4%; P = 0.001), with similar stroke rates between groups. On landmark analysis, mortality was similar between groups after 30 days (P = 0.91). CONCLUSIONS: In this first report of the EXPLANTORREDO-TAVR global registry, TAVR-explant had a shorter median time to reintervention, with less structural valve degeneration, more prosthesis-patient mismatch, and similar paravalvular leak rates compared with redo-TAVR. TAVR-explant had higher mortality at 30 days and 1 year, but similar rates on landmark analysis after 30 days.

Utility of Multidetector Computed Tomographic Angiography as an Alternative to Transesophageal Echocardiogram for Preoperative Transcatheter Mitral Valve Repair Planning.

BACKGROUND: Three-dimensional (3D) transesophageal echocardiogram (TEE) is the gold standard for the diagnosis of degenerative mitral regurgitation (dMR) and preoperative planning for transcatheter mitral valve repair (TMVr). TEE is an invasive modality requiring anesthesia and esophageal intubation. The severe acute respiratory syndrome coronavirus 2 pandemic has limited the number of elective invasive procedures. Multi-detector computed tomographic angiography (MDCT) provides high-resolution images and 3D reconstructions to assess complex mitral anatomy. We hypothesized that MDCT would reveal similar information to TEE relevant to TMVr, thus deferring the need for a preoperative TEE in certain situations like during a pandemic. METHODS: We retrospectively analyzed data on patients who underwent or were evaluated for TMVr for dMR with preoperative MDCT and TEE between 2017 and 2019. Two TEE and 2 MDCT readers, blinded to patient outcome, analyzed: leaflet pathology (flail, degenerative, mixed), leaflet location, mitral valve area (MVA), flail width/gap, anterior-posterior (AP) and commissural diameters, posterior leaflet length, leaflet thickness, presence of mitral valve cleft and degree of mitral annular calcification (MAC). RESULTS: A total of 22 (out of 87) patients had preoperative MDCT. MDCT correctly identified the leaflet pathology in 77% (17/22), flail leaflet in 91% (10/11), MAC degree in 91% (10/11) and the dysfunctional leaflet location in 95% (21/22) of patients. There were no differences in the measurements for MVA, flail width, commissural or AP diameter, posterior leaflet length, and leaflet thickness. MDCT overestimated the measurements of flail gap. CONCLUSIONS: For preoperative TMVr planning, MDCT provided similar measurements to TEE in our study.

Lifetime management for aortic stenosis: Planning for future therapies.

A shift to lifetime management has gained more focus with the approval of low-risk transcatheter aortic valve replacement (TAVR). This paper is therefore focused on the different approaches for lifetime management. Herein we discuss the procedural safety, durability, performance, and future options for each lifetime management strategy. In younger patients that elect to undergo surgical aortic valve replacement (SAVR), options for bioprosthetic failure are TAV-in-SAV or redo SAVR. Among patients that undergo TAVR, options for valve failure include TAVR explant with SAVR or TAV-in-TAV. Additionally, there are patients who may require a third valvular intervention. The initial therapy may limit re-intervention options down the road. This review discusses how options for future therapies affect the decision of SAVR vs TAVR in younger patients.

Mitral Regurgitation in the High-Risk Patient: Integrating an Expanding Armamentarium of Transcatheter Devices Into the Treatment Algorithm.

Over the last decade, multiple transcatheter mitral valve repair and replacement strategies have emerged, yet there is only 1 US Food and Drug Administration approved device, the MitraClip (Abbott Vascular, Inc., Santa Clara, CA). Current guidelines support the use of the MitraClip in high or prohibitive surgical risk patients, but there are many patients that are not anatomically suited for the device. This review article discusses the approach to degenerative and functional mitral regurgitation in the high-prohibitive risk patient, how to choose transcatheter treatment options (both approved and investigational), and potential management for therapy failure.

Variability and Reproducibility of the SYNTAX Score for Triple-Vessel Disease.

BACKGROUND: The SYNTAX score (SX) is an angiographic grading system to determine the burden and complexity of coronary artery disease (CAD) and to guide operators as to the appropriateness of percutaneous coronary intervention (PCI) vs coronary artery bypass grafting (CABG). However, variability of the SX may exist since the assessment relies on individual clinicians to visually interpret lesion severity and characteristics. We therefore aimed to assess SX variability and reproducibility among interpreting physicians. METHODS: Fifty patient angiograms were randomly selected from a registry of patients with multi-vessel CAD (treated with PCI or CABG) completed at our institution during the years 2011-2018. Each angiogram was evaluated by 6 clinicians on 2 separate occasions (minimum 8 weeks between occasions) for a total of 600 SX. Our goal was to evaluate both inter- and intra- observer reliability of SX scores. Variation in both raw score as well as risk classification (low, intermediate or high SX) was observed. Inter- and intra-observer reliability were assessed using the intra-class correlation coefficient (ICC), Cohen's weighted Kappa, and Fleiss' Kappa. RESULTS: SYNTAX scores on both assessments and across all 6 cardiologists had a mean score of 25.3. On the first assessment, the ICC for the inter-observer reliability of SX scores was 0.61 (95% CI: 0.50, 0.73). Across the 6 observers, only 16% of angiograms were classified in the same risk classification by all observers. 34% of angiograms had less than a majority agreement (3 or less observers) on risk classification. The weighted Kappa for intra-observer reliability of risk classification scores ranged from 0.30 to 0.81. Across the 6 observers, the proportion of angiograms classified as the same risk classification between each observer's 1st and 2nd assessment ranged from 46% to 84%. CONCLUSION: This study shows a wide inter- and intra- user variability in calculating SX. Our data indicates a significant limitation in using the SX to guide revascularization strategies. Further studies are needed to determine more reliable ways to quantitate burden of CAD.

The Importance of Pre-Operative Imaging and 3-D Printing in Transcatheter Tricuspid Valve-in-Valve Replacement.

Pre-operative multimodality imaging has become an integral part of the planning and execution of transcatheter heart valve procedures. 3D printing of a patient-specific cardiac model is a novel addition to these procedures. This case report discusses the use of pre-operative multimodality imaging, intra-operative fusion imaging, and 3D printing as valuable adjuncts in the planning and simulation of complex structural heart procedures. We describe the case of a 44-year-old woman with prior tricuspid bioprosthetic valve replacement and mechanical mitral valve replacement who presented with dyspnea and palpitations. The patient was diagnosed with severe tricuspid bioprosthestic valve failure, was deemed high risk for surgical re-intervention, and subsequently underwent successful tricuspid valve-in-valve replacement with a SAPIEN XT valve.

Preoperative multidetector computed tomography for isolated surgical aortic valve replacement: Planning for future transcatheter options.

BACKGROUND: Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has become a valuable option in patients with bioprosthetic failure. However, potential issues with ViV TAVR may occur in patients with high-risk anatomy for coronary obstruction and patients with baseline smaller bioprosthetic valves at risk for patient prosthesis mismatch. The purpose of this study was, therefore, to use preoperative electrocardiography-gated, multidetector computed tomography (MDCT) in patients undergoing isolated surgical aortic valve replacement (SAVR) to (1) identify which would be high risk for coronary occlusion with ViV TAVR, and (2) predict intraoperative SAVR sizing. METHODS: Among 223 patients from our institutions' database that underwent SAVR for aortic insufficiency (AI) or aortic stenosis (AS) between January 2012 and January 2020, 48 patients had MDCT imaging before surgery (AI; n = 31, AS; n = 17). Of all patients, 67% (n = 32) were bicuspid morphology. RESULTS: With the use of virtual valve implantation, all patients with AI and bicuspid AS had feasible anatomy for ViV TAVR, while 38% of patients with tricuspid AS were high risk for coronary obstruction. There was a strong correlation between actual valve size implanted and preoperative MDCT measurements using annulus average diameter, area, and/or perimeter. CONCLUSION: Preoperative MDCT in patients undergoing SAVR is a useful tool for lifetime management, particularly in patients with tricuspid AS. Decisions for surgical management may change based on MDCT's ability to predict intraoperative SAVR size and determine which patients may be high-risk candidates for future ViV TAVR due to coronary artery obstruction.

Long-term survival in triple-vessel disease: Hybrid coronary revascularization compared to contemporary revascularization methods.

BACKGROUND: Hybrid coronary revascularization (HCR) constitutes a left internal mammary artery graft to the left anterior descending (LAD) coronary artery, coupled with percutaneous coronary intervention (PCI) for non-LAD lesions. This management strategy is not commonly offered to patients with complex multivessel disease. Our objective was to evaluate 8-year survival in patients with triple-vessel disease (TVD) treated by HCR, compared with that of concurrent matched patients managed by traditional coronary artery bypass grafting (CABG) or multivessel PCI. METHODS: A retrospective review was undertaken of 4805 patients with TVD who presented between January 2009 and December 2016. A cohort of 100 patients who underwent HCR were propensity-matched with patients treated by CABG or multivessel PCI. The primary endpoint was all-cause mortality at 8 years. RESULTS: Patients with TVD who underwent HCR had similar 8-year mortality (5.0%) as did those with CABG (4.0%) or multivessel PCI (9.0%). A composite endpoint of death, repeat revascularization, and new myocardial infarction, was not significantly different between patient groups (HCR 21.0% vs CABG 15.0%, P = .36; HCR 21.0% vs PCI 25.0%, P = .60). Despite a higher baseline synergy between percutaneous coronary intervention with taxus and cardiac surgery(SYNTAX) score, HCR was able to achieve a lower residual SYNTAX score than multivessel PCI (P = .001). CONCLUSIONS: In select patients with TVD, long-term survival and FREEDOM from major adverse cardiovascular events after HCR are similar to that seen after traditional CABG or multivessel PCI. HCR should be considered for patients with multivessel disease, presuming a low residual SYNTAX score can be achieved.

Transcatheter aortic valve-in-valve-in-valve implantation with three-dimensional printing guidance: A case report.

BACKGROUND: Valve-in-valve implantation (ViV) has become a valid option for the treatment of bioprosthetic valve failure. We describe the first in-man transfemoral transcatheter aortic valve replacement (TAVR) or "turducken" in a patient with previous TAVR within surgical aortic valve replacement with preprocedural guidance utilizing three-dimensional (3D) printing and intraprocedural guidance with fusion imaging. CASE SUMMARY: A 65-year-old male with a previous valve-in-valve with a transcatheter Melody valve presented with symptomatic severe valvular and paravalvular aortic incompetence. Using 3D printing for preprocedural guidance and computed tomography angiography-fluoroscopy fusion imaging for intraprocedural guidance we successfully placed a 29 mm self-expanding valve with minimal residual gradients. The patient continued to be asymptomatic at 1- and 5-year follow-up. DISCUSSION: We describe the first in man aortic valve-in-valve-in-valve using preprocedural guidance with 3D printing and intraprocedural guidance with fusion imaging. The valve has continued to demonstrate good function up to 5 years postprocedure suggesting that transcatheter aortic valve-in-valve-in-valve may be feasible with the proper pre- and intraprocedural guidance.

Hybrid Minimally Invasive Approach for Combined Obstructive Coronary Artery Disease and Severe Aortic Stenosis.

OBJECTIVE: There is a high prevalence of concomitant coronary artery disease (CAD) and aortic stenosis (AS), and these conditions can be treated with a variety of invasive and/or percutaneous approaches. The aim of this study is to demonstrate the feasibility, efficacy, and safety of a staged transcatheter aortic valve replacement (TAVR) after a hybrid minimally invasive direct coronary artery bypass surgery (MIDCAB) to treat combined complex CAD and AS. METHODS: Six patients with concomitant CAD and severe AS underwent staged treatment of their CAD with MIDCAB and TAVR. All patients had significant complex left main or left anterior descending artery (LAD) stenosis deemed to be not amenable to percutaneous coronary intervention (PCI). RESULTS: The average syntax score was 22±8 and the Society of Thoracic Surgeons score for surgical AVR was 8±3%. All patients underwent a single vessel MIDCAB for revascularization of the LAD (three patients required additional PCI for non-LAD disease). Two patients had pre-TAVR balloon aortic valvuloplasty and one patient also required treatment of severe mitral valve regurgitation with percutaneous edge-to-edge repair (the MitraClip). There was no intraprocedural or hospital mortality. No neurological deficits or vascular complications were recorded. CONCLUSIONS: A hybrid staged approach for combined complex CAD and severe AS with MIDCAB, PCI, and TAVR is a valid option in high-risk patients. The order and timing of these procedures must be tailored to the patient's clinical symptoms, stability, and severity of disease.

Subclinical leaflet thrombosis following transcatheter aortic valve replacement.

Since the inception of transcatheter aortic valve replacement (TAVR), there have been significant reductions in complications due to improvements of transcatheter heart valve (THV) designs and technologies. Given expanding TAVR applications, reducing complications further and better understanding THV durability has become a focus within the structural heart space. Recently, dedicated cardiac computed tomographic angiography (CTA) performed at 1 month post-TAVR has identified subclinical leaflet thrombosis (SLT), with rates as high as 40%. From the SLT imaging hallmarks of hypoattenuated leaflet thickening (HALT) to hypoattenuation affecting motion (HAM), a postulated timeline of THV thrombosis advancing to clinical symptoms can be recognized. This review article focuses on leaflet thrombosis particularly following TAVR explaining the spectrum of this disease process, its diagnosis, current treatment options, and future directions in the field.

Transinnominate approach for transcatheter aortic valve replacement: single-centre experience of minimally invasive alternative access.

OBJECTIVES: Iliofemoral arteries have been the preferred access for transcatheter aortic valve replacement (TAVR). When these arteries are too small, calcified or tortuous, an alternative access must be considered. Transinnominate (TI) access is an extrathoracic approach that does not require manipulation of major neurovascular structures or the apex. The aim of this study is to evaluate the efficacy and safety of TI TAVR as an alternative access in patients with severe aortic stenosis not amenable to a transfemoral approach. METHODS: Thirteen patients with severe aortic stenosis underwent TI TAVR between February 2016 and January 2017 at our institution. The average Society of Thoracic Surgeons (STS) score was 7.7 ± 4.5%. Eight patients had previous surgical revascularization, 7 of which involved the left thoracic artery. All patients underwent preoperative computed tomography angiography that revealed significant atheromatous and calcific disease of the iliofemoral vessels and/or the descending aorta. The innominate artery was found to be of appropriate calibre (>10 mm), free of plaque and easy to access via surgical incision. Fusion multimodality imaging was utilized in all cases to guide the procedure. RESULTS: The innominate artery was accessed via a 2-inch right parasternal supraclavicular incision. Nine self-expandable valves and 4 balloon-expandable valves were implanted. Procedural success occurred in all cases without intraprocedural and in-hospital mortality. No neurological deficits or vascular complications were recorded; postoperative bleeding was trivial. Ten patients were discharged on Day 3 and 3 patients who required PPM on Day 5. CONCLUSIONS: TI approach represents a safe, reproducible and minimally invasive hybrid technique for TAVR in high-risk patients. In our early experience, surgical trauma and perioperative complications are minimal with rapid patient recovery.

Minimally Invasive Robotically Assisted Repair of Partial Anomalous Venous Connection.

We describe a novel robotically assisted minimally invasive surgical technique for repair of partial anomalous pulmonary vein connection (PAPVC). Partial anomalous pulmonary vein connection is a rare congenital anomaly that consists in drainage of one or more pulmonary veins into the systemic venous system. Traditionally, large thoracotomy incision and sometimes establishment of cardiopulmonary bypass are needed to redirect the abnormal pulmonary vein to the left-sided reservoir. We describe a robotically assisted, minimally invasive, off-pump technique for the treatment of the left PAPVC in a 57-year-old patient with signs of progressive right ventricular dilatation. The Da Vinci robot was used for mediastinal dissection and isolation of the distal aspect of the left superior anomalous pulmonary vein from the brachiocephalic vein. Through a left minithoracotomy, under direct vision, the pulmonary vein was reanastomosed to the left atrial appendage, thus reconstituting a normal venous return pattern. The use of the da Vinci robot is a valid adjunct for correction of the left PAPVC. It helps mediastinal dissection and allows reconnection of the pulmonary vein to the left venous system via a small thoracotomic incision and without the use of cardiopulmonary bypass.