Real-world experience with concomitant or staged transcatheter aortic and mitral valve replacements using balloon-expandable valves.

OBJECTIVE: To describe outcomes of patients who underwent transcatheter aortic valve replacement (TAVR) in a native valve or failed bioprosthetic valve or transcatheter heart valve (THV) and a transcatheter mitral valve replacement procedure (TMVR; valve-in-valve [mViV], valve-in-ring [mViR], and valve in mitral annulus calcification [ViMAC]) either concomitantly (same procedure) or staged (different procedures). BACKGROUND: Patient characteristics, procedural details, and outcomes of concomitant or staged TAVR and TMVR procedures are largely unknown. METHODS: Data were extracted from the STS/ACC TVT Registry™ for patients undergoing concomitant or staged TAVR and TMVR with SAPIEN XT, SAPIEN 3, or SAPIEN 3 Ultra (Edwards Lifesciences) THVs. Descriptive results were reported for procedural, index hospitalization, 30-day, and 1-year outcomes. RESULTS: A total of 257 patients underwent TAVR and TMVR in concomitant (n = 135) or staged (n = 122) procedures. Device success was 82.9% and 83.9% for concomitant TAVR and TMVR procedures and 83.8% and 82.5% for staged TAVR and TMVR procedures. Significant improvements in aortic and mitral valve function remained stable through 1 year. All-cause mortality for concomitant and staged groups was 14.7% and 10.5% at 30 days, and 32.8% and 24.6% at 1 year, respectively. Stroke rate for concomitant and staged groups was 0.8% and 3.6% at 30 days and 3.9% and 5.6% at 1 year, respectively. Improvements from baseline to 1 year in NYHA class and KCCQ overall summary scores were observed for all patients. CONCLUSIONS: Concomitant or staged transcatheter treatment of patients with aortic and mitral valve disease can be performed in select high-risk patients in experienced centers.

Transcatheter vacuum-assisted left-sided mass extraction with the AngioVac system.

OBJECTIVES: To study the safety and efficacy of AngioVac for left-sided transcatheter vacuum-assisted mass extraction (TVME). BACKGROUND: The AngioVac system is approved for right-sided TVME and has emerged as an effective and safe alternative for open surgical treatment. The use of the AngioVac device for aspiration of left-sided TVME has been limited. METHODS: Consecutive patients from two Michigan centers who underwent left-sided TVME were included. Data on patient demographics, procedural information, in-hospital and follow-up events were collected through electronic medical records review. Technical success was defined as aspirating of 70%-100% of the material. RESULTS: Ten patients (mean age 58.3 [±17.3] years, 50% male) were included. Indications for TMVE were in large for recurrent embolic events. All patients underwent bilateral cerebro-embolic protection using the Sentinel device. The total mean procedure time was 192.5 (±47.5) min of which the meantime for active aspiration (bypass time) was 9.3 (±4.2) min. The circuit configuration was: arteriovenous (AV) in four cases and arterioarterial (AA) in six cases. Successful aspiration was achieved in 80% of cases. No complications were reported (range follow-up 1-16 months). CONCLUSIONS: Our small case series demonstrates the feasibility and safety of the AngioVac system in left-sided mass extraction. Larger trials are needed to further demonstrate its effectiveness and safety and potentially apply for on-label use.

Transcatheter Mitral Valve Replacement in Failed Bioprosthetic Surgical Valves and Surgical Annuloplasty Rings.

PURPOSE OF REVIEW: Repeat surgery for failed mitral valve prostheses and repairs are fraught with high rates of morbidity and mortality. Therefore, clinicians have evolved transcatheter technology as an alternative therapy. This review serves as an update as the field has moved out of the early learning curve of treating postsurgical mitral valve failures. RECENT FINDINGS: Mitral valve-in-valve procedures have higher rates of technical success and better in-hospital and 1-year mortality rates than mitral valve-in-ring cases. The higher rates of complications, including left ventricular outflow tract obstruction, paravalvular leak, valve embolization, and need for a 2nd valve, may explain these outcomes. Mitral valve-in-ring procedures have attenuated outcomes as compared to valve-in-valve. Clinicians should be cognizant of the nuanced complexities and the potential for suboptimal outcomes in using balloon-expandable valves for mitral valve-in-ring procedures.

Pacemaker following transcatheter aortic valve replacement and tricuspid regurgitation: A single-center experience.

BACKGROUND: As transcatheter aortic valve replacement (TAVR) procedures increase, more data is available on the development of conduction abnormalities requiring permanent pacemaker (PPM) implantation post-TAVR. Mechanistically, new pacemaker implantation and incidence of associated tricuspid regurgitation (TR) post-TAVR is not well understood. Studies have evaluated the predictability of patient anatomy towards risk for needing permanent pacemaker (PPM) post-TAVR; however, little has been reported on new PPM and TR in patients post-TAVR. METHODS: This retrospective study identified patients at our health system who underwent PPM following TAVR from January 2014 to June 2018. Data from both TAVR and PPM procedures as well as patient demographics were collected. Echocardiographic data before TAVR, between TAVR and PPM placement, and the most recent echocardiogram at the time of chart review were analyzed. RESULTS: Of 796 patients who underwent TAVR between January 2014 and June 2018, 89 patients (11%) subsequently required PPM. Out of the 89 patients who required PPM implantation, 82 patients had pre-TAVR and 2-year post-TAVR echocardiographic imaging data. At baseline, 22% (18/82) of patients had at least moderate TR. At 2-year post-TAVR echocardiographic imaging follow-up; 27% (22/82) of patients had at least moderate TR. Subgroup analysis was performed according to the TAVR valve size implanted. In patients who received a TAVR device < 29 mm in diameter in size, 25% (11/44) had worsening TR. In patients who received a TAVR device ≥ 29 mm in diameter, 37% (14/38) had worsening TR. CONCLUSION: We have demonstrated a patient population that may be predisposed to developing worsening TR and right heart function after TAVR and Pacemaker implantation.

Real world outcomes using 20 mm balloon expandable SAPIEN 3/ultra valves compared to larger valves (23, 26, and 29 mm)-a propensity matched analysis.

OBJECTIVE/BACKGROUND: Small balloon expandable valves have higher echocardiographic transvalvular gradients and rates of prosthesis-patient mismatch (PPM) compared to larger valves. However, the impact of these echocardiographic findings on clinical outcomes is unknown. We sought to determine the clinical outcomes of 20 mm SAPIEN 3 (S3 BEV) compared to larger S3 BEV in relation to echocardiographic hemodynamics. METHODS: Using the STS/ACC transcatheter valve registry, we performed a propensity-matched comparison of patients undergoing treatment of native aortic valve stenosis using transfemoral, balloon-expandable implantation of 20 mm and ≥ 23 mm S3 BEVs. Baseline and procedure characteristics, echocardiographic variables and survival were analyzed. Multivariable logistic regression was used to identify predictors of 1-year mortality. RESULTS: After propensity matching of the 20 mm and ≥ 23 mm SAPIEN 3 valves, 3,931 pairs with comparable baseline characteristics were identified. Small valves were associated with significantly higher echocardiographic gradients at discharge (15.7 ± 7.1 mmHg vs. 11.7 ± 5.5 mmHg, p < 0.0001) and severe PPM rates (21.5% vs. 9.7%, p < 0.0001). There was no significant difference in 1-year all-cause mortality (20 mm: 13.0% vs. ≥23 mm: 12.7%, p = 0.72) or other major adverse event rates and outcomes between the two cohorts. Based on a multivariable analysis, elevated discharge mean gradient (>20 mmHg), severe PPM and the use of 20 mm versus ≥23 mm were not independent predictors of 1-year mortality. CONCLUSION: SAPIEN 3 20 mm valves were associated with higher echocardiographic gradients, and severe PPM rates compared to larger valves but these factors were not associated with significant differences in 1-year all-cause mortality or rehospitalization.

First-in-human transcatheter pledget-assisted suture tricuspid annuloplasty for severe tricuspid insufficiency.

OBJECTIVES: We report the first pledget-assisted suture tricuspid annuloplasty (PASTA) in a patient with torrential tricuspid regurgitation (TR). BACKGROUND: Tricuspid valve regurgitation is a common malignant disease with no commercially available transcatheter therapy. PASTA is a "percutaneous surgical" procedure using pledgeted sutures to create a double-orifice tricuspid valve. METHODS: An 83-year-old man had end-stage TR caused by a defibrillator lead. He consented to undergo PASTA on a compassionate basis. A double-orifice valve was created with pledgeted sutures from percutaneous right ventricular apical access. RESULTS: TR was reduced from torrential to trace. The vena contracta reduced to from 23 to 1 mm and annular area reduced from 1817 to 782 mm2 . However, the annulus dehisced and required closure with a percutaneous nitinol plug. The patient was discharged home and was alive 6 months later but with persistent symptoms. CONCLUSIONS: The anatomy of a double-orifice valve can eliminate TR but a better solution is required to avoid excessive suture tension on annular tissue.

Short- and mid-term outcomes in percutaneous mitral valve replacement using balloon expandable valves.

BACKGROUND: Due to elevated surgical risk, transcatheter mitral valve replacement (TMVR) is used as an alternative for treating failed bioprosthetic valves, annuloplasty repairs and mitral annular calcification (MAC). We report the procedural and longitudinal outcomes for each subtype: Mitral valve-in-valve (MVIV), mitral valve-in-ring (MViR), and valve-in-MAC (ViMAC). METHODS: Consecutive patients undergoing TMVR from October 2013 to December 2019 were assessed. Patients at high risk for left ventricular outflow tract obstruction had either alcohol septal ablation or intentional laceration of the anterior leaflet (LAMPOON). RESULTS: Eight-eight patients underwent TMVR; 38 MViV, 31 MViR, and 19 ViMAC procedures were performed. The median Society of Thoracic Surgery 30-day predicted risk of mortality was 8.2% (IQR 5.2, 19.9) for all. Sapien 3 (78%) and transseptal access (98%) were utilized in most cases. All-cause in-hospital mortality, technical, and procedural success were 8%, 83%, and 66% respectively. Median follow up was 1.4 years (IQR 0.5-2.9 years) and overall survival was 40% at 4 years. Differential survival rates were observed with MViV doing the best, followed by MViR and ViMAC having a <20% survival at 4 years. After adjusting for co-variates, MViV procedure was the strongest predictor of survival (HR 0.24 [95% CI 0.079-0.7]). CONCLUSION: TMVR is performed in at high-risk patients with attenuated long-term survival. MViV has the best success and survival rate, but long-term survival in MViR and ViMAC is guarded.

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.

Complete percutaneous apical access and closure: Short and intermediate term outcomes.

OBJECTIVES: To examine the safety of utilizing transapical access during structural interventions. BACKGROUND: Complex interventions of the mitral or aortic region sometimes require coaxial forces to orient and deliver devices. Apical access can provide coaxial countertraction for either transseptal or retrograde aortic access. This manuscript describes the single center experience of small bore transapical access. METHODS: Retrospective review of cases from 2013 to 2018 at Henry Ford Hospital was performed. Patient demographics and procedure characteristics were abstracted to describe the safety of transapical access using small bore sheaths. RESULTS: A total 21 cases were performed at Henry Ford, most of them for transcatheter mitral valve replacement (81%). The mean sheath size used was 4.7 ± 0.9 Fr and protamine was used at the end of 57% of cases. All patients received nitinol-based plugs, 80.1% were from the Amplatz Duct Occluder II type. Four major complications related apical puncture occurred, two pericardial effusions, two hemothorax. Over a median follow time of 430 days (IQR 50-652) a total of five deaths occurred, two related to the procedure and three late deaths with a median time of 362 days (range 205-628 days). No deaths were associated with transapical access. Echocardiographic follow up did not detect any late structural complications from occluder devices. CONCLUSIONS: Transapical access and closure with nitinol-based devices is feasible and facilitates complex interventions where coaxial forces are need for device delivery and alignment. The most common complication is bleeding and this should be kept in perspective when treating high-risk patients.

Transcaval Access for Large Bore Devices.

PURPOSE OF REVIEW: Examine the latest data and techniques regarding transcaval access and closure. RECENT FINDINGS: Transcaval access was proven to be a feasible and a translatable skill in a 100 patient open-label prospective study. No late complications from fistulas occurred and of all patients alive at 1 year, one fistula remained open. Transcaval is a viable access route for large bore devices. With adequate planning, bleeding and vascular complications are minimal. It should be integrated into the rubric of transcatheter large bore access.

Watchman in ascending aorta for systemic protection (WAASP): Novel use of Watchman in ascending aorta for embolic protection-first in man.

We report two cases where left atrial appendage closure (LAA) with Watchman was successfully performed despite presence of definite LAA thrombus. Because there was the risk of thrombus dislodgement, we transiently placed an additional Watchman device in the ascending aorta for embolic protection. © 2017 Wiley Periodicals, Inc.

Guidewire electrosurgery-assisted trans-septal puncture.

OBJECTIVES: Electrifying a coronary guidewire may be a simple escalation strategy when trans-septal needle puncture is unsuccessful. BACKGROUND: Radiofrequency energy to facilitate trans-septal puncture through a dedicated device is costly and directly through a trans-septal needle may be less safe. Our technique overcomes these limitations. METHODS: The technique was used in patients when trans-septal needle penetration failed despite excessive force or tenting of the atrial septum. A coronary guidewire, connected to an electrosurgery pencil, was advanced through the trans-septal needle, dilator, and sheath to perforate the interatrial septum during a short burst of radiofrequency energy. With the guidewire tip no longer "active," the dilator and sheath were advanced safely over the wire into the left atrium. In posthoc validation, radiofrequency assisted Brockenbrough needle and coronary guidewire punctures were made in freshly explanted pig hearts and compared under microscopy. RESULTS: Eight patients who required trans-septal access for structural intervention were escalated to a guidewire electrosurgery strategy. Six patients had thickened fibrotic septum and two had prior surgical patch repair. Crossing was successful in all patients with no procedure related complications. The size of punctures (1.11 ± 0.40 mm vs 0.37 ± 0.08 mm, P = .009) and blanched penumbra (3.62 ± 1.23 mm vs 0.72 ± 0.29 mm, P = .003) in pig atrial septum were larger with an electrified needle than electrified guidewire. The hole generated by the electrified guidewire was smaller than by the nonelectrified needle. CONCLUSIONS: When conventional trans-septal puncture fails, a coronary guidewire can be used to deliver brief radiofrequency energy safely and effectively. This technique is inexpensive and accessible to operators.

Validating a prediction modeling tool for left ventricular outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR).

OBJECTIVE: Demonstrate proof-of-concept validation of a computed tomography (CT) computer-aided design prediction modeling tool to identify patients at risk for left ventricular outflow tract (LVOT) obstruction in transcatheter mitral valve replacement (TMVR). BACKGROUND: LVOT obstruction is a significant and even fatal consequence of TMVR. METHODS: From August 2013 to August 2017, 38 patients in 5 centers underwent TMVR with compassionate use of balloon-expandable valves for severe mitral valve dysfunction because of degenerative surgical mitral ring, bioprosthesis, or severe native mitral stenosis from to severe mitral annular calcification. All patients had preprocedural CT scans performed for anatomic screening, intraprocedural TEE and invasive hemodynamics performed. Preprocedural prediction modeling was performed utilizing computer-aided design (CAD) of the neo-LVOT post-TMVR. Post-TMVR CT scans were obtained and compared to pre-TMVR LVOT modeling datasets for validation. RESULTS: All patients underwent successful TMVR without device embolization. Seven of the 38 patients experienced LVOT obstruction, defined as an increase of ≥10 mmHg LVOT peak gradient post-TMVR. Anatomic screening using CT was validated in 20/38 patients as preprocedural predicted neo-LVOT surface area correlated well with post-TMVR measurements (R2 = 0.8169, P < 0.0001). A receiver operating curve curve found a predicted neo-LVOT surface area of ≤ 189.4 mm2 to have 100% sensitivity and 96.8% specificity for predicting TMVR-induced LVOT obstruction. CONCLUSION: CAD design and CT postprocessing are indispensable tools in predicting LVOT obstruction and necessary for anatomic screening in percutaneous TMVR.

Prospective, randomized comparison of 3-dimensional computed tomography guidance versus TEE data for left atrial appendage occlusion (PRO3DLAAO).

BACKGROUND: Preliminary data comparing 3-dimensional computed tomography (3D-CT) to transesophageal echocardiography (TEE) for left atrial appendage occlusion (LAAO) indicates that 3D-CT provides more accurate measurements and improves case planning. Therefore, we conducted a pilot study comparing 3D-CT to TEE in occluder selection accuracy and procedural efficiency. METHODS: From May 2016 to February 2017, 24 patients were prospectively randomized to undergo LAAO using either TEE or 3D-CT. The primary endpoint was device accuracy while the secondary endpoints included # devices per case, # guide catheters used per case, # fluoroscopy angles used, procedure time, fluoroscopy time, radiation dose, and major adverse events (stroke, MI, device embolization, perforation, death). RESULTS: Procedure success was 100% and 92% for the 3D-CT and 2D-TEE cohorts respectively. Accuracy for 1st device selection 92% and 27% (P = .01) for 3D-CT and 2D-TEE respectively but with intra-procedural upsizing in the 2D-TEE cohort, the 2D-TEE cohort accuracy increased to 64% while the 3D-CT groups 92% was accurate (P = .33). Case planning using 3D-CT was significantly more efficient with respect to device utilization (CT 1.33 ± 0.7 vs. 2D-TEE 2.5 ± 1.2 P = .01), guide catheters (CT 1 vs. 2D-TEE 1.7 ± 0.8 P = .01) and procedure time (3D-CT 55 ± 17 min vs. 2D-TEE 73 ± 24 min P < .05). One major adverse event, a stroke occurred in the 2D-TEE group. CONCLUSION: In this single-center pilot study, CT guided LAAO case planning was associated with improved device selection accuracy and procedural efficiency. This study data supports the notion that comprehensive 3D assessment significantly simplifies LAAO, minimizing the time and number of steps needed.

Transcatheter Mitral Valve Therapy: Defining the Patient Who Will Benefit.

PURPOSE OF REVIEW: This report aims to define the clinical and anatomic variables key in determining patient suitability for transcatheter mitral valve therapies. RECENT FINDINGS: Candidacy for transcatheter mitral valve repair requires weighing the clinical variables that may impact the ability to improve patient symptoms and prolong survival that include left ventricular ejection fraction, symptom severity, pulmonary hypertension, and magnitude of residual regurgitation or stenosis. Individualized selection of transcatheter repair or replacement based on patho-anatomy is being explored. The primary goal is achieving significant reduction in mitral regurgitation. Transcatheter mitral valve replacement requires rigorous anatomic screening using computed tomography and candidates should be able to take oral anticoagulation. Selection of patients for transcatheter mitral valve repair is complex and requires intimate knowledge of clinical variables and specific device limitations.

Power of gradients.

Patients with high baseline gradients benefit most after TAVR. In severe symptomatic aortic stenosis, every 10 mm Hg increase in mean gradient has 20% reduction in mortality after TAVR. Low gradient severe aortic stenosis continues to be a clinical cohort with variable benefit from TAVR.