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.

Comparison of clinical outcomes between use of overexpanding an undersized versus nominal-sized SAPIEN 3 ultra transcatheter heart valve in patients with borderline annulus area.

BACKGROUND: For patients with borderline annulus areas that fall between two valve sizes, overinflating a smaller balloon-expandable transcatheter heart valve (THV) may be preferable to nominal sizing of a larger THV. OBJECTIVES: To evaluate the outcomes of nominal preparation versus over-expanding an under-sized SAPIEN 3 Ultra (S3U) transcatheter heart valve (OE-THV) in cases with borderline annuli. METHODS: 958 patients that underwent TAVR with the S3U at four high-volume TAVR centers between January 2017 and December 2020 were retrospectively reviewed. 336 patients were identified as borderline annuli size, of which 146 (44%) received OE-THVs and 190 (56%) received nominal-sized THVs. The primary composite endpoint included: in-hospital mortality, aortic injury, moderate/severe paravalvular leak (PVL), permanent pacemaker implant (PPM), stroke, or conversion to surgery. RESULTS: Baseline characteristics were similar except for a larger percentage of females in the OE-THV (53.42% vs. 42.11%, p = 0.04). TAVR with OE-THV resulted a reduction in the primary composite endpoint (13.69% vs. 22.63%, p = 0.04). On subgroup analysis, there was no difference between 20 mm OE-THV versus 23 mm nominal or 23 mm OE-THV versus 26 mm nominal, but there was a reduction in the primary composite endpoint in patients with larger annuli that received a 26 mm OE-THV compared to the 29 mm nominally sized THV (9.7% vs. 27.4%, p = 0.02). At 1 month and 1 year follow-up, there was no significant difference in mortality, PVL rates, NYHA class, and/or KCCQ score. CONCLUSION: Overinflating a smaller-sized S3U THV may be a safer option in comparison to nominal sizing in patients with borderline annular area.

Transcatheter heart valve selection in patients with low ejection fraction and aortic stenosis.

OBJECTIVE: The aim of this study was to compare outcomes of transcatheter heart valve (THV) choice in patients with left ventricular (LV) systolic dysfunction. BACKGROUND: The management congestive heart failure with combined LV systolic dysfunction and severe aortic stenosis (AS) is challenging, yet transcatheter aortic valve replacement (TAVR) has emerged as a suitable treatment option in such patients. Head-to-head comparisons among the balloon-expandable (BEV) and self-expandable (SEV) THV remain limited in this subgroup of patients. METHODS: In this retrospective study, we included patients with severe AS with LV systolic dysfunction (LVEF ≤40%) who underwent TAVR at four high volume centers. Two thousand and twenty-eight consecutive patients were analyzed, of which 335 patients met inclusion criteria. One hundred fourty-six patients (43%) received a SEV, and 189 patients (57%) received a BEV. RESULTS: Baseline characteristics were similar except for a higher proportion of females in the SEV group. The primary composite endpoint of in-hospital mortality, moderate or greater paravalvular (PVL), stroke, conversion to open surgery, aortic valve reintervention, and/or need for permanent pacemaker (PPM) was no different among THV choice. There was more PVL in the SEV group, but higher transaortic gradients in the BEV group. Clinical outcomes and quality of life measures were similar up to 1 year follow-up. CONCLUSION: The choice of THV in patients with severe AS and systolic dysfunction must be weighed on a case-by-case basis.

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.

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.

Reoperative mitral valve surgery via sternotomy or right thoracotomy: A propensity-matched analysis.

BACKGROUND: There is, as yet, no broad consensus regarding the optimal surgical approach for patients requiring reoperative mitral valve surgery. Consequently, we sought to evaluate the perioperative outcomes for patients undergoing redo mitral surgery via right mini thoracotomy as compared with traditional resternotomy. METHODS: A comprehensive retrospective review of our prospectively collected database was undertaken from January 2011 to December 2017. We propensity matched 90 patients who underwent reoperative mitral valve surgery via right mini thoracotomy with a concurrent cohort of patients who had redo median sternotomy. Intraoperative data and short-term clinical outcomes were analyzed. RESULTS: The 30-day mortality was 3.3% (six deaths) in the entire cohort, not significantly different between redo sternotomy and mini thoracotomy groups. Patients who had their procedure via right mini thoracotomy had reduced intensive care unit (P = .029) and overall hospital (P < .0001) lengths of stay, a diminished requirement for perioperative transfusion (P = .023), and a trend towards faster postoperative extubation. Right thoracotomy patients experienced shorter cardiopulmonary bypass (P = .012) and cardiac arrest (P < .0001) times than did the sternotomy cases. Peripheral cannulation was utilized more frequently in the mini thoracotomy group, as were fibrillatory arrest techniques. CONCLUSION: Reoperative mitral valve surgery via right mini thoracotomy is safe, and is associated with shorter extracorporeal circulation times, reduced transfusion, and faster postoperative recovery.

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.

Available transcatheter aortic valve replacement technology.

Transcatheter aortic valve replacement (TAVR) is an alternative and now recommended therapy for patients who meet indications for surgical valve replacement and are high or prohibitive surgical risk. Available TAVR technologies are rapidly emerging to treat this complex patient population. This review discusses the specific valve designs of the transcatheter heart valves currently used, newer generation modifications to overcome limitations of earlier valve designs, and novel imaging modalities, such as computed tomographic angiography-fluoroscopy and echocardiography-fluoroscopy fusion imaging, available for pre-procedural planning and intra-procedural guidance.

Treatment options for isolated aortic valve insufficiency: a review.

Aortic insufficiency (AI) is a valvular disease with increasing prevalence in older patients. The modern era provides numerous options for the management of AI which is explored here. Traditional interventions included aortic valve replacement with either mechanical or bioprosthetic aortic valves. While the former is known for its durability, it has grown out of favor due to the potential complications of anticoagulation. The preference for bioprosthetic valves is thus on the rise, especially with the advancements of transcatheter technology and the use of valve-in-valve therapy. Surgical options are also no longer limited to replacement but include complex techniques such as those required for aortic valve repair, Ozaki neocuspidization, Ross procedure and valve-sparring aortic root repair. Transcatheter options for the management of AI are not commercially available currently; however, preliminary data from ad-hoc trials, showed promising results and potential use of transcatheter technology in a variety of patients with pure AI.

Hydrodynamic Assessment of Explanted Degenerated Transcatheter Aortic Valves: Novel Insights Into Noncalcific and Calcific Mechanisms.

BACKGROUND: The etiology of transcatheter aortic valve (TAV) degeneration is poorly understood, particularly noncalcific mechanisms. OBJECTIVES: The authors sought to investigate noncalcific and calcific mechanisms of TAV degeneration and evaluate their impact on leaflet function by bench testing, imaging, and histology. METHODS: TAV explants were obtained from the EXPLANT THV registry and clinical institutions. Hydrodynamic assessment was performed using a heart valve pulse duplicator system under physiological conditions. Micro-computed tomography, high-resolution photography, high speed video, and hematoxylin and eosin staining were used to evaluate the morphological appearance, leaflet kinematics, and calcium burden of TAVs. RESULTS: A total of 14 explants were evaluated: 10 self-expanding CoreValve/Evolut TAVs (Medtronic), 3 balloon-expandable SAPIEN 3 TAVs (Edwards Lifesciences), and 1 mechanically expandable Lotus TAV (Boston Scientific). The median patient age at explantation was 73.0 years (Q1-Q3: 64.5-80.0 years), with a time to explantation of 4 years 1 month (1 year 5 months to 4 years 11 months). Six TAV explants were found to have leaflet calcification (162.4 mm3; 58.8-603.0 mm3), and 8 had no calcification detectable by micro-computed tomography and histology. All samples had impaired leaflet kinematics. There was no significant difference in the hydrodynamic mean gradient between calcified (47.2 mm Hg; 26.6-74.1 mm Hg) and noncalcified (27.6 mm Hg; 15.2-36.7 mm Hg; P = 0.28) TAVs. Leaflet calcification had a weak but nonsignificant association with the hydrodynamic mean gradient (r = 0.42; P = 0.14). CONCLUSIONS: TAV function can be severely impacted by noncalcific and calcific mechanisms of tissue degeneration. Importantly, functional stenosis can occur in TAVs in the absence of obvious and significant calcification.

The utility and impact of outpatient telemetry monitoring in post-transcatheter aortic valve replacement patients.

BACKGROUND: Conduction disturbances are a common complication of transcatheter aortic valve replacement (TAVR). Mobile Cardiac Telemetry (MCT) allows for continuous monitoring with near "real time" alerts and has allowed for timely detection of conduction abnormalities and pacemaker placement in small trials. A standardized, systematic approach utilizing MCT devices post TAVR has not been widely implemented, leading to variation in use across hospital systems. OBJECTIVES: Our aim was to evaluate the utility of a standardized, systematic approach utilizing routine MCT to facilitate safe and earlier discharge by identifying conduction disturbances requiring permanent pacemaker (PPM) placement. We also sought to assess the occurrence of actionable arrhythmias in post-TAVR patients. METHODS: Using guidance from the JACC Scientific Expert Panel, a protocol was implemented starting in December 2019 to guide PPM placement post-TAVR across our health system. All patients who underwent TAVR from December 2019 to June 2021 across four hospitals within Northwell Health, who did not receive or have a pre-existing PPM received an MCT device at discharge and were monitored for 30 days. Clinical and follow-up data were collected and compared to pre initiative patients. RESULTS: During the initiative 693 patients were monitored with MCT upon discharge, 21 of whom required PPM placement. Eight of these patients had no conduction abnormality on initial or discharge ECG. 59 (8.6 %) patients were found to have new atrial fibrillation or flutter via MCT monitoring. There were no adverse events in the initiative group. Prior to the initiative, 1281 patients underwent TAVR over a one-year period. The initiative group had significantly shorter length of stay than pre-initiative patients (2.5 ± 4.5 vs 3.0 ± 3.8 days, p < 0.001) and lower overall PPM placement rate within 30 days post-TAVR (16 % vs 20.5 %, P = 0.0125). CONCLUSIONS: In our study, implementation of a standardized, systematic approach utilizing MCT in post-TAVR patients was safe and allowed for timely detection of conduction abnormalities requiring pacemaker placement. This strategy also detected new atrial fibrillation and flutter. Reduction in post TAVR pacemaker rate and length of stay were also noted although this effect is multifactorial.

Kissing balloon inflation for transcatheter aortic valve replacement and abutting ostial coronary artery stent.

In patients with ostial coronary stents protruding into the aorta, there is concern for stent injury while undergoing transcatheter aortic valve replacement (TAVR) with balloon-expandable transcatheter heart valve (THV). An 82-year-old male with history of symptomatic aortic stenosis, heart failure, and coronary artery disease with multiple interventions to right coronary artery (RCA) and a history of stent fracture requiring stent-in-stent placement one year previously, was evaluated for TAVR. His ostial RCA stent was protruding into the aorta at the level of sinotubular junction, with ostial stent to aortic wall (SAW) distance of 25.2 mm. There was concern for balloon inflation during TAVR leading to stent injury. The RCA was cannulated with a 6 French JR4 guide and wired with 0.014' coronary wire. Appropriately sized noncompliant balloon was advanced into RCA. Under rapid pacing, the coronary balloon was inflated across the RCA ostium followed by simultaneous deployment of THV. Intravascular imaging of the ostial RCA stent revealed no stent fracture. SAW distance is important to determine the possibility of balloon-induced stent injury during valve deployment. In cases where an ostial stent may interact with balloon inflation, kissing-balloon inflation may be performed to prevent stent injury. Learning objective: In patients with ostial coronary stents protruding into the aorta, stent to aortic wall distance is important to determine the possibility of balloon-induced stent injury during balloon-expandable transcatheter heart valve deployment. Kissing-balloon inflation may be performed to prevent stent injury.

Comparison of Periprocedural and Intermediate-Term Outcomes of TAVI in Patients with Ejection Fraction ≤ 20% vs. Patients with 20% < EF ≤ 40.

Treatment of congestive heart failure (CHF) with left ventricular (LV) systolic dysfunction and severe aortic stenosis (AS) is challenging, yet transcatheter aortic valve replacement (TAVR) has emerged as a suitable treatment option in such patients. We compared the periprocedural outcomes of TAVR in patients with an ejection fraction (EF) of ≤20% (VLEF group) to patients with an EF > 20% to ≤40% (LEF group). We included patients with severe AS and reduced LV ejection fraction (LVEF ≤ 40%) who underwent TAVR at four centers within Northwell Health between January 2016 and December 2020. Over 2000 consecutive patients were analyzed, of which 355 patients met the inclusion criteria. The primary composite endpoint was in-hospital mortality, moderate or greater paravalvular (PVL), stroke, conversion to open surgery, aortic valve re-intervention, and/or need for PPM. Secondary endpoints were length of stay, NYHA classification at 1 month and 1 year, mortality at 1 month and 1 year, mean valve gradient at 1 month, KCCQ score at 1 month, and ≥ moderate PVL at 1 month. There was no difference in the primary composite endpoint between the two groups (23.6% for VLEF vs. 25.3% for LEF, p = 0.29). During TAVR placement, 40% of patients in the VLEF group required ≥1 vasopressors for hypotension lasting ≥30 min vs. only 21% of patients in the LEF group (p < 0.01). Intra-aortic balloon pump (IABP) use during procedure was greater in the VLEF group (9% vs. 1%, p < 0.01)-all placed post TAVR. Emergency ECMO use was higher in the VLEF group as well (5% vs. 0%). Total length of stay was significantly different between the two groups as well (6 days vs. 3 days, p < 0.01). Both groups had a change in LVEF of ~10%. One-year outcomes were similar between the groups. All-cause mortality at 1 year was not significantly different at 1 year (13% for VLEF vs. 11% for LEF), and KCC scores were also similar (77.54 vs. 74.97). Mean aortic valve gradients were also similar (12 mmHg vs. 11 mmHg, p = 0.48). Our study suggests that patients with EF ≤ 20% can safely have TAVR with similar periprocedural outcomes compared to patients with EF > 20% to ≤40% despite higher rates of vasopressor and mechanical support.

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.

Short- and Mid-Term Outcomes of Complex and High-Risk Versus Standard Percutaneous Coronary Interventions in Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: The prevalence of coronary artery disease (CAD) in patients undergoing TAVR varies and is associated with increased morbidity and mortality. We evaluated the outcomes of complex and high-risk percutaneous coronary interventions (CHIP-PCIs) and TAVR compared with standard PCI and TAVR. Between January 2014 and March 2021, a total of 276 consecutive patients with severe aortic stenosis (AS) who underwent TAVR and PCI at 3 centers within Northwell Health were retrospectively reviewed. CHIP-PCI was defined as PCI with one of the following: left ventricular ejection fraction (LVEF) <30%; left main coronary artery (LMCA)/chronic total occlusion (CTO) intervention; atherectomy; or need for left ventricular (LV) support. One hundred twenty- seven patients (46%) had CHIP-PCI prior to TAVR and 149 patients (54%) had standard PCI. Thirteen percent of CHIP-PCI and 22% of standard PCI cases were done concomitantly with TAVR. CHIP-PCI criteria were met for low EF (19%), LMCA (25%), CTO (3%), LV support (20%), and atherectomy (50%). The types of valves used were similarly divided (49% balloon expandable vs 51% self expanding. Major adverse cardiac or cerebrovascular event (MACCE) rate for CHIP-PCI/TAVR was 4.9% at 30 days vs 1.3% for standard PCI/TAVR (P=.09), driven by in-hospital stroke. At 1 year, the rates of MACCE for CHIP-PCI/TAVR remained higher than for standard PCI/TAVR, but was not statistically significant (8.7% vs 4%; P=.06), driven by revascularization. We found no differences between major and/or minor vascular complications. New York Heart Association classification at 1 month was similar (I/II 93% vs 95%; P=.87). Our study suggests that CHIP-PCI can be safely performed in patients with complex CAD and concomitant severe AS.

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.

Minimally invasive coronary bypass versus percutaneous coronary intervention for isolated complex stenosis of the left anterior descending coronary artery.

OBJECTIVE: Debate continues as to the optimal minimally invasive treatment modality for complex disease of the left anterior descending coronary artery, with advocates for both robotic-assisted minimally invasive direct coronary artery bypass and percutaneous coronary intervention with a drug-eluting stent. We analyzed the midterm outcomes of patients with isolated left anterior descending disease, revascularized by minimally invasive direct coronary artery bypass or drug-eluting stent percutaneous coronary intervention, focusing on those with complex lesion anatomy. METHODS: A retrospective review was undertaken of all patients who underwent coronary revascularization between January 2008 and December 2016. From this population, 158 propensity-matched pairs of patients were generated from 158 individuals who underwent minimally invasive direct coronary artery bypass for isolated complex left anterior descending disease and from 373 patients who underwent percutaneous coronary intervention using a second-generation drug-eluting stent. Midterm survival and incidence of repeat left anterior descending intervention were analyzed for both patient groups. RESULTS: Overall 9-year survival was not significantly different between patient groups both before and after propensity matching. Midterm mortality in the matched minimally invasive direct coronary artery bypass group was low, irrespective of patient risk profile. By contrast, advanced age (hazard ratio, 1.10; P = .012) and obesity (hazard ratio, 1.09; P = .044) predicted increased late death after drug-eluting stent percutaneous coronary intervention among matched patients. Patients who underwent minimally invasive direct coronary artery bypass were significantly less likely to require repeat left anterior descending revascularization than those who had percutaneous coronary intervention, both before and after propensity matching. Smaller stent diameter in drug-eluting stent percutaneous coronary intervention was associated with increased left anterior descending reintervention (hazard ratio, 3.53; P = .005). CONCLUSIONS: In patients with complex disease of the left anterior descending artery, both minimally invasive direct coronary artery bypass and percutaneous coronary intervention are associated with similar excellent intermediate-term survival, although reintervention requirements are lower after surgery.

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.

A Novel Computed Tomographic Angiography Tortuosity Index to Predict Successful Sentinel Cerebral Embolic Protection Delivery for Transcatheter Aortic Valve Replacement.

Background: Percutaneous transradial placement of the Sentinel cerebral embolic protection device (CEPD) (Boston Scientific) is indicated during transcatheter aortic valve replacement to capture embolic material in patients without excessive tortuosity of the right subclavian/innominate arteries. We aimed to generate a quantitative tortuosity index (TI) from the preoperative computed tomographic angiography (CTA) as an objective measure of tortuosity to determine suitability for CEPD placement. Methods: Eighty-one patients considered for CEPD were included in this study. A centerline of the right subclavian/innominate arteries was generated from preoperative CTA scans. Three-dimensional Cartesian coordinates of landmarks along the centerline were used to calculate curvature. Tortuosity was derived as a change in angulation along each vessel segment. Peak and average TI values were calculated. Results: Sixty-seven patients had CEPD placement attempted. Unsuccessful CEPD placement occurred in 3 of 67 (4.4%) patients. The peak tortuosity for the successful, unsuccessful, and visually tortuous (not attempted) cohorts were 49.66 ± 11.96°/cm, 113.92 ± 5.70°/cm, and 70.44 ± 17.01°/cm, respectively. The peak and average TI of the successful cohort follows a normal distribution. A proposed TI cutoff for safe CEPD was peak tortuosity of 74°/cm and average tortuosity of 30°/cm, 2 standard deviations above the peak and average TI of the successful cohort. All unsuccessful CEPD patients fell outside the boundaries. Half of the visually tortuous patients were within the boundaries but did not have CEPD attempted. Conclusions: A novel TI based on preoperative CTA can assist in selecting patients for transradial CEPD. Our proposed quantitative tool may help to appropriately include and exclude patients for CEPD placement.