Balloon rupture during transcatheter aortic valve replacement.

A distinctive complication with balloon-expandable (BE) THV platforms such as the Edwards Sapien (Edwards Lifescience) is the possibility of balloon rupture during THV deployment. Balloon rupture is a rare occurrence that can result in stroke due to fragment embolism, incomplete THV expansion, and/or vascular injury upon retrieval of the balloon. Careful evaluation of preoperative computed tomography is essential to identify high-risk cases. While annular and left ventricular outflow tract (LVOT) calcification are widely acknowledged as common risks for balloon injury, it's essential to note that balloon injury can manifest at various anatomical sites. In this review, we discuss the mechanism behind balloon rupture, methods to identify cases at a heightened risk of balloon injury, approaches to mitigate the risk of rupture, and percutaneous retrieval strategies.

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.

Early outcomes from the CLASP IID trial roll-in cohort for prohibitive risk patients with degenerative mitral regurgitation.

OBJECTIVES: We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site. BACKGROUND: The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site. METHODS: Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed. RESULTS: A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p < .001) with improvements in 6MWD (30 m; p = .054) and KCCQ (17 points; p < .001). CONCLUSIONS: Early results representing sites with first experience with the PASCAL repair system showed favorable 30-day outcomes in patients with DMR≥3+ at prohibitive surgical risk.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions (SCAI) 2021 think tank.

The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community annually for high-level field-wide discussions. The 2021 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease. Each session was moderated by a senior content expert and co-moderated by a member of SCAI's Emerging Leader Mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward.

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.

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis.

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.

Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves.

BACKGROUND: A finding of reduced aortic-valve leaflet motion was noted on computed tomography (CT) in a patient who had a stroke after transcatheter aortic-valve replacement (TAVR) during an ongoing clinical trial. This finding raised a concern about possible subclinical leaflet thrombosis and prompted further investigation. METHODS: We analyzed data obtained from 55 patients in a clinical trial of TAVR and from two single-center registries that included 132 patients who were undergoing either TAVR or surgical aortic-valve bioprosthesis implantation. We obtained four-dimensional, volume-rendered CT scans along with data on anticoagulation and clinical outcomes (including strokes and transient ischemic attacks [TIAs]). RESULTS: Reduced leaflet motion was noted on CT in 22 of 55 patients (40%) in the clinical trial and in 17 of 132 patients (13%) in the two registries. Reduced leaflet motion was detected among patients with multiple bioprosthesis types, including transcatheter and surgical bioprostheses. Therapeutic anticoagulation with warfarin, as compared with dual antiplatelet therapy, was associated with a decreased incidence of reduced leaflet motion (0% and 55%, respectively, P=0.01 in the clinical trial; and 0% and 29%, respectively, P=0.04 in the pooled registries). In patients who were reevaluated with follow-up CT, restoration of leaflet motion was noted in all 11 patients who were receiving anticoagulation and in 1 of 10 patients who were not receiving anticoagulation (P<0.001). There was no significant difference in the incidence of stroke or TIA between patients with reduced leaflet motion and those with normal leaflet motion in the clinical trial (2 of 22 patients and 0 of 33 patients, respectively; P=0.16), although in the pooled registries, a significant difference was detected (3 of 17 patients and 1 of 115 patients, respectively; P=0.007). CONCLUSIONS: Reduced aortic-valve leaflet motion was shown in patients with bioprosthetic aortic valves. The condition resolved with therapeutic anticoagulation. The effect of this finding on clinical outcomes including stroke needs further investigation. (Funded by St. Jude Medical and Cedars-Sinai Heart Institute; Portico-IDE ClinicalTrials.gov number, NCT02000115; SAVORY registry, NCT02426307; and RESOLVE registry, NCT02318342.).

Propensity matched comparison of in-hospital outcomes of TAVR vs. SAVR in patients with previous history of CABG: Insights from the Nationwide inpatient sample.

BACKGROUND: The incidence of patients with previous history of coronary artery bypass grafting (CABG) presenting for aortic valvular replacement has been consistently on the rise. Repeat sternotomy for surgical aortic valve replacement (SAVR) carries an inherent risk of morbidity and mortality when compared to Transcatheter aortic valve replacement (TAVR). METHODS: The Nationwide inpatient sample (NIS) from 2012 to 2014 was queried using the International Classification of Diseases-Ninth edition, Clinical Modification (ICD-9-CM) codes to identify all patients ≥ 18 years with prior CABG who underwent TAVR (35.05 and 35.06) or SAVR (35.21 and 35.22). Propensity score matching (1:1) was performed and in-hospital outcomes were compared between matched cohorts. RESULTS: From 2012 to 2014, there was progressive increase in the annual number of TAVR procedures from 1485 to 4020, with a decrease in patients undergoing SAVR from 2330 to 1955 (Ptrend < 0.0001) in the above population. There was no significant difference in in-hospital mortality rates. Compared to SAVR, TAVR was associated with lower risk of stroke (1.2% vs. 3.3%, P = 0.009), AKI (12.9% vs. 21.3%, P < 0.0001), myocardial infarction (0.9% vs. 2.7%, P = 0.01) and major bleeding (9.1% vs. 25.1%, P < 0.0001). TAVR was associated with higher risk of pacemaker implants (9.6% vs. 4.9%, P = 0.001) and trend toward lower risk of vascular complications (2.3% vs. 4.1%, P = 0.05). CONCLUSION: In this large cohort of patients with previous CABG, there is no significant difference in in-hospital mortality between TAVR and SAVR. TAVR was associated with lower risk of in-hospital outcomes.

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.

Valve in valve transcatheter aortic valve implantation (ViV-TAVI) versus redo-Surgical aortic valve replacement (redo-SAVR): A systematic review and meta-analysis.

BACKGROUND: Bioprosthetic (BP) valves have been increasingly used for aortic valve replacement over the last decade. Due to their limited durability, patients presenting with failed BP valves are rising. Valve in Valve - Transcatheter Aortic Valve Implantation (ViV-TAVI) emerged as an alternative to the gold standard redo-Surgical Aortic Valve Replacement (redo-SAVR). However, the utility of ViV-TAVI is poorly understood. METHODS: A systematic electronic search of the scientific literature was done in PubMed, EMBASE, SCOPUS, Google Scholar, and ClinicalTrials.gov. Only studies which compared the safety and efficacy of ViV-TAVI and redo-SAVR head to head in failed BP valves were included. RESULTS: Six observational studies were eligible and included 594 patients, of whom 255 underwent ViV- TAVI and 339 underwent redo-SAVR. There was no significant difference between ViV-TAVI and redo- SAVR for procedural, 30 day and 1 year mortality rates. ViV-TAVI was associated with lower risk of permanent pacemaker implantation (PPI) (OR: 0.43, CI: 0.21-0.89; P = 0.02) and a trend toward increased risk of paravalvular leak (PVL) (OR: 5.45, CI: 0.94-31.58; P = 0.06). There was no significant difference for stroke, major bleeding, vascular complications and postprocedural aortic valvular gradients more than 20 mm-hg. CONCLUSION: Our results reiterate the safety and feasibility of ViV-TAVI for failed aortic BP valves in patients deemed to be at high risk for surgery. VIV-TAVI was associated with lower risk of permanent pacemaker implantation with a trend toward increased risk of paravalvular leak.

The role of percutaneous vacuum-assisted thrombectomy for intracardiac and intravascular pathology.

Vacuum-assisted thrombectomy (VAT) is a mechanical suction device that can be deployed to aspirate thrombi in the heart and vascular system. Successful percutaneous aspiration of iliocaval, right heart, and pulmonary arterial thrombi have been reported, in addition to the debulking of intravascular and intracardiac masses and vegetations. VAT is indicated for patients who are poor surgical candidates and/or have a contraindication to thrombolysis. This review discusses the mechanism, current results, potential clinical indications, and limitations of VAT for iliocaval and intracardiac mass removal.

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.

Novel approach for the percutaneous treatment of left ventricular pseudoaneurysms.

Left ventricular pseudoaneurysm (LVPA) is a rare yet serious complication that may follow cardiac surgery, myocardial infarction, trauma, or infection. If left untreated, reported rates of rupture and sudden cardiac death are high. Although surgical intervention has traditionally been the standard treatment for LVPA, percutaneous closure is now an attractive alternative in the high-risk patient. We report a case of a successful percutaneous LVPA closure using direct chest wall entry into the pseudoaneurysm. This novel approach can be useful when access to the LVPA is a challenge, especially in the setting of small ostial size, dense left ventricular trabeculations, angulated serpiginous tract, and presence of mechanical prostheses.

Review of surgical prosthetic paravalvular leaks: diagnosis and catheter-based closure.

Paravalvular leak (PVL) is an uncommon yet serious complication associated with surgical prosthetic valve implantation. Paravalvular leak can have significant clinical consequence such as congestive heart failure, haemolytic anaemia, and infective endocarditis. Recently, transcatheter therapy has been applied to the treatment of this disorder with reasonable procedural and clinical success. This review discusses the current state of PVLs, the utilization of multi-modality imaging in their diagnosis and treatment, and the available therapeutic options. Further aim of this review is to examine transcatheter therapy of PVLs including the principles, outcomes, and procedural-related complications.

IntraCardiac echocardiography-guided leaflet modification for coronary protection prior to transcatheter valve-in-valve replacement.

A 79-year-old man with a failed 25-mm CE Magna Ease 3300 surgical prosthesis (Edwards Lifesciences) and of high re-operative surgical risk (STS 8%) presented with dyspnea, NYHA III. Cardiac computed tomography angiography revealed anatomy that was high risk for coronary occlusion with a short right coronary artery height of 6 mm and a valve-to-coronary distance of 2 mm.