Clinical characteristics and outcomes of alcohol septal ablation in the era of transcatheter valve interventions.

BACKGROUND: The clinical efficacy and safety of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) have been well-established; however, less is known about outcomes in patients undergoing preemptive ASA before transcatheter mitral valve replacement (TMVR). AIMS: The goal of this study is to characterize the procedural characteristics and examine the clinical outcomes of ASA in both HCM and pre-TMVR. METHODS: This retrospective study compared procedural characteristics and outcomes in patient who underwent ASA for HCM and TMVR. RESULTS: In total, 137 patients were included, 86 in the HCM group and 51 in the TMVR group. The intraventricular septal thickness (mean 1.8 vs. 1.2 cm; p < 0.0001) and the pre-ASA LVOT gradient (73.6 vs. 33.8 mmHg; p ≤ 0.001) were higher in the HCM group vs the TMVR group. The mean volume of ethanol injected was higher (mean 2.4 vs. 1.7 cc; p < 0.0001). The average neo-left ventricular outflow tract area increased significantly after ASA in the patients undergoing TMVR (99.2 ± 83.37 mm2 vs. 196.5 ± 114.55 mm2; p = <0.0001). The HCM group had a greater reduction in the LVOT gradient after ASA vs the TMVR group (49.3 vs. 18 mmHg; p = 0.0040). The primary composite endpoint was higher in the TMVR group versus the HCM group (50.9% vs. 25.6%; p = 0.0404) and had a higher incidence of new permanent pacemaker (PPM) (25.5% vs. 18.6%; p = 0.3402). The TMVR group had a higher rate of all-cause mortality (9.8% vs. 1.2%; p = 0.0268). CONCLUSIONS: Preemptive ASA before TMVR was performed in patients with higher degree of clinical comorbidities, and correspondingly is associated with worse short-term clinical outcomes in comparison to ASA for HCM patients. ASA before TMVR enabled percutaneous mitral interventions in a small but significant minority of patients that would have otherwise been excluded. The degree of LVOT and neoLVOT area increase is significant and predictable.

Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study.

BACKGROUND AND AIMS: For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes. METHODS: The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year. RESULTS: Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III-IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure. CONCLUSIONS: In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490.

Permutations in pacer wire implantation in patients evaluated for transcatheter tricuspid valve interventions.

Pacer wire induced tricuspid regurgitation is not well-understood. The mechanisms behind pacer wired induced tricuspid regurgitation have not been clearly defined. This clinical vignette sets to identify different technical mechanisms behind cardiac lead induced tricuspid regurgitation to help optimize cardiac lead implantation strategies for future device implantation.

3D print and multi-modality imaging guided transcatheter closure of multiple left ventricular pseudoaneurysms.

Left ventricular pseudoaneurysm (PSA) after surgical aortic valve replacement (AVR) is a known but uncommon complication. It is associated with risks such as thromboembolism and life-threatening rupture. Surgical repair has traditionally been utilized in low-risk patients but transcatheter closure has become a promising therapeutic option. This case report describes the utility of multimodality imaging in pre-, intra-, and post-procedural evaluation of transcatheter PSA closure and is among the first to demonstrate the utility of 3D print model.

Comparative differences of mitral valve-in-valve implantation: A new mitral bioprosthesis versus current mosaic and epic valves.

OBJECTIVE: Evaluate transcatheter mitral valve replacement (TMVR) valve-in-valve (VIV) outcomes in three different mitral bioprostheses (of comparable measured internal diameters) under stable hemodynamic and surgical conditions by bench, echocardiographic, computerized tomography (CT), and autopsy comparisons pre- and post-valve implantation in a porcine model under matched controlled conditions. BACKGROUND: Impact of surgical bioprosthesis design on TMVR VIV procedures is unknown. METHODS: Fifteen similar-sized Yorkshire pigs underwent pre-procedural CT screening. Twelve had consistent anatomic features and underwent implantation of mitral bioprostheses. Four valves from each of three manufacturers were implanted in randomized fashion: 27-mm Epic, 27-mm Mosaic, and 25-mm Mitris, followed by TMVR VIV with 26 Edwards Sapien3. Post-VIV, suprasternal TEE studies were performed to assess hemodynamic function, followed by a gated contrast CT. After euthanasia, animals underwent necropsy for anatomic evaluation. RESULTS: All 12 animals had successful VIV implantation with no study deaths. The post vivMitris (3.77 ± 0.36)/(2.2 ± 0.25 mmHg) had the lowest peak/mean trans-mitral gradient and the vivEpic the highest (15.5 ± 2.55)/(7.09 ± 1.13 mmHg). All THVs (transcatheter heart valves) had greatest deformation within the center of the THV frame; with the smallest waist opening area in the vivEpic (329 ± 35.8 mm2 ) and greatest in the vivMitris (414 ± 33.12 mm2 ). Bioprosthetic frames without obvious radiopaque markers resulted in the most ventricular implantation of the THV's anteroseptal frame (Epic: -4.52 ± 0.76 mm), versus the most radiopaque bioprosthesis (Mitris: -1.18 ± 2.95 mm), and higher peak LVOT gradients (Epic: 4.82 ± 1.61 mmHg; Mitris: 2.91 ± 1.47 mmHg). CONCLUSIONS: The current study demonstrates marked variations in hemodynamics, THV opening area, and anatomic dimensions among measured similarly sized mitral bioprostheses. These data suggest a critical need for understanding the potential impact of variations in bioprosthesis design on TMVR VIV clinical outcomes.

Initial in-human experience with the conveyor cardiovascular system for the delivery of large profile transcatheter valve devices.

OBJECTIVES: To determine the safety and efficacy of the conveyor cardiovascular system (CCS) to facilitate the delivery of large profile transcatheter valve devices. BACKGROUND: Transcatheter valve devices rely on force provided by the operator to be delivered to their intended position. This delivery may be challenging in a variety of anatomic scenarios. The ability to provide steering from the tip of the device by forming an arterial venous loop may help overcome these challenges. METHODS: Between May, 2019 and October, 2020, five patients were recruited for delivery of transcatheter valve devices with the CCS. These patients were deemed by the operators to have challenging anatomy which could make conventional valve delivery difficult or impossible. These patients were recruited as part of an FDA approved early feasibility study or through an institutional review board approved compassionate use protocol. RESULTS: Three patients underwent transcatheter mitral valve replacement with a SAPIEN-3 valve. One patient each underwent transcatheter aortic valve (TAVR) implantation with a SAPIEN 3 and 1 patient underwent TAVR implantation with a Lotus valve. All patients underwent successful implantation of the valve and removal of the CCS and valve delivery systems. There was no more than trivial mitral regurgitation post procedure in any patient and there was no more than trivial paravavular leak. There were no major in-hospital complications. CONCLUSIONS: The CCS facilitates the delivery of large profile transcatheter valve devices in challenging anatomic scenarios. Further studies are needed with additional valve technologies.

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.

Preclosure of large bore venous access sites in patients undergoing transcatheter mitral replacement and repair.

OBJECTIVE: We aim to report on the efficacy and safety of large bore venous access (LBVA) preclosure with Perclose™ (Abbott Vascular Devices) suture-mediated device use following transcatheter edge-to-edge (TEER) and replacement (TMVR). BACKGROUND: Patients requiring TEER and TMVR require LBVA. Clinical outcome data on the use of suture-mediated devices for LBVA site closure are limited. METHODS: Between 2012 and 2019, 354 consecutive high-risk patients with mitral valvular heart disease underwent TEER (n = 287) with MitraClip and TMVR (n = 67) with Edwards Sapien Valves. Patients had LBVA with 24 or 16 French sheaths. All patients underwent preclosure of LBVA except for one that underwent manual hemostasis. RESULTS: There were no closure device failures. None of the cases required surgical repair of the access site following venous preclosure. Two cases had large hematomas (>6 cm) following Perclose in each group. Six cases had small hematomas (<6 cm and >2 cm) with three in each group. There was one major bleeding using Mitral Valve Academic Research Consortium 2 definition (retroperitoneal bleed from arterial puncture) unrelated to the venous closure. Transfusion related to vascular access complication was required in five cases. There were two immediate acute deep venous thromboses postprocedure; one of which occurred after preclosure. There were no arteriovenous malformations, pseudoaneurysms, or access site infections reported following Perclose. CONCLUSION: In this large sample size analysis, Proglide preclosure technique is a feasible and safe alternative approach to achieving hemostasis after removal of LBVA sheaths in patients undergoing TEER and TMVR. Randomized trials are needed to compare the different modalities of hemostasis.

The impact of pulmonary hypertension on outcomes of transcatheter mitral valve replacement in mitral annular calcification.

OBJECTIVES: To assess the impact of pulmonary hypertension (PH) on outcomes of patients with severe mitral annular calcification (MAC) undergoing transcatheter mitral valve replacement (TMVR). BACKGROUND: PH is associated with poor outcomes after mitral valve surgery. Whether the presence of PH in patients with MAC undergoing (TMVR) is associated with poor outcomes, is unknown. METHODS: Retrospective evaluation of 116 patients from 51 centers in 11 countries who underwent TMVR with valve in mitral annular calcification (ViMAC) using balloon-expandable aortic transcatheter valves (THVs) from September 2012 to March 2017. Pulmonary artery systolic blood pressure (PASP) by echocardiogram was available in 90 patients. The subjects were stratified based on PASP: No PH = PASP ≤35 mmHg (n = 11); mild to moderate PH = PASP 36-49 mmHg (n = 21) and severe PH = PASP ≥50 mmHg (n = 58). Clinical, procedural, and echocardiographic outcomes were assessed. RESULTS: Mean age was 72.7 (±12.8) years, 59 (65.6%) were female, Society of Thoracic Surgeons score was 15.8 + 11.8% and 90.0% where in New York Heart Association (NYHA) class III-IV. There was no significant difference in all-cause mortality at 30 days (no PH = 27.3%, mild-moderate PH = 19.0%, severe PH = 31.6%; p = 0.55) or at 1 year (no PH = 54.5%, mild-moderate PH = 38.1%, severe PH = 56.1%; p = 0.36). No difference in adverse events, NYHA class or amount of residual mitral regurgitation at 1 year were observed between the groups. CONCLUSION: This study suggests that the presence of PH in patients with predominantly mitral stenosis with MAC undergoing TMVR does not impact mortality or adverse events. Further studies are needed to fully understand the effect of PH in this group of patients.

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.

Non-coaptation of an implanted caval valve leaflets for severe tricuspid regurgitation: Rethinking the concept of "Eustachian ridge?"

Severe symptomatic tricuspid regurgitation (TR) remains an undertreated disease. Multiple trans-catheter treatment options are currently under investigation. Transcatheter caval valve implantation (CAVI) has been utilized as a treatment option and aims at decreasing or eliminating the caval backflow that occurs in severe TR patients. Understanding challenges with this therapy is paramount. Hereby we present a CAVI case with resultant non-coaptation of valve leaflets in a patient with a prominent Eustachian ridge.

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.

Incidence of acquired ventricular septal defect after transcatheter aortic valve replacement: A large single center experience.

OBJECTIVE: To determine the rate and clinical outcomes of post-TAVR VSD. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a safe and established procedure for patients with severe symptomatic aortic stenosis. Ventricular septal defect (VSD) is a rare complication of TAVR. The rate of post-TAVR VSD and patient outcomes are not well known. METHODS: A retrospective record review of VSD cases occurring after all TAVRs performed between January 2012 and September 2020 at one urban US tertiary hospital. VSD rate and early- and long-term outcomes were analyzed. Computed tomography images taken before TAVR and transthoracic echocardiograms done before and after each procedure were analyzed. RESULTS: Of the 1908 patients who underwent TAVR in the study period, 7 patients (0.37%) had post-procedure VSD. The average patient age was 77 ± 11 years with average society of thoracic surgeons short-term risk score of 6%. All 7 implanted valves were balloon-expandable. Of the 7 TAVR procedures, 5 were performed on a native tricuspid valve, 1 was performed on a native bicuspid valve, and 1 was done as a "valve-in-valve" procedure on a prior surgical bioprosthetic valve. All VSDs were small and restrictive in nature. Right heart failure in a patient with preexisting right ventricular dysfunction occurred in 1 (13%) patient who died. The remaining 6 patients (86%) were discharged. All 6 patients (86%) were alive and stable at 1 year follow-up, reporting improvement in symptoms (NYHA class I-II), with no evidence of right ventricular dysfunction. CONCLUSION: VSD is a rare complication of TAVR. Hemodynamic and clinical sequelae in majority of the patients in this study did not result in mortality. Proper imaging techniques and appropriate pre-procedure planning are needed to decrease the incidence of VSD formation post-TAVR.

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.

Comparison of Deep Sedation and General Anesthesia With an Endotracheal Tube for Transcaval Transcatheter Aortic Valve Replacement: A Pioneering Institution's Experience.

OBJECTIVES: Transcaval transcatheter aortic valve replacement (TC-TAVR) is an alternative approach to transcatheter aortic valve replacement involving deployment of the bioprosthetic valve via a conduit created from the inferior vena cava to the descending aorta in patients for whom the traditional transfemoral approach is not feasible. By analyzing the largest known cohort of TC-TAVR patients, the authors wished to compare hospital length of stay and post-procedure outcomes between patients who underwent the procedure under deep sedation (DS) and patients who underwent general anesthesia with an endotracheal tube. DESIGN: Retrospective, single-center study. SETTING: Henry Ford Hospital in Detroit, MI. PARTICIPANTS: Patients undergoing TC-TAVR from 2015 to 2018. MEASUREMENTS AND MAIN RESULTS: Seventy-nine patients were included in the analysis, which consisted of 38 under general anesthesia with an endotracheal tube and 41 under DS. The sample was divided into a general anesthesia (GA) group and DS group. There were no significant differences in implant success rate or post-procedure outcomes, including in-hospital mortality (p = 0.999) and major vascular complication rate (p = 0.481), between the two groups. Patients in the GA group stayed a median of 24 hours longer in the intensive care unit (ICU) (p < 0.001) and one day longer in the hospital (p = 0.046) after the procedure compared to patients in the DS group. The median procedure time was significantly lower (135 minutes) in the DS group compared to the GA group (167 minutes, p < 0.001). CONCLUSIONS: Patients undergoing TC-TAVR under DS had similar postoperative outcomes and shorter post-procedure hospital and ICU lengths of stay compared to general anesthesia. In the authors' experience, DS is the preferred anesthetic technique for TC-TAVR.

Comparison of a new bioprosthetic mitral valve to other commercially available devices under controlled conditions in a porcine model.

BACKGROUND/AIM: To evaluate three mitral bioprostheses (of comparable measured internal diameters) under controlled, stable, hemodynamic and surgical conditions by bench, echocardiographic, computerized tomography and autopsy comparisons pre- and postvalve implantation. METHODS: Fifteen similar-sized Yorkshire pigs underwent preprocedural computerized tomography anatomic screening. Of these, 12 had consistent anatomic features and underwent implantation of a mitral bioprosthesis via thoracotomy on cardiopulmonary bypass (CPB). Four valves from each of three manufacturers were implanted in randomized fashion: 27-mm Epic, 27-mm Mosaic, and 25-mm Mitris bioprostheses. After CPB, epicardial echocardiographic studies were performed to assess hemodynamic function and define any paravalvular leaks, followed by postoperative gated contrast computerized tomography. After euthanasia, animals underwent necropsy for anatomic evaluation. RESULTS: All 12 animals had successful valve implantation with no study deaths. Postoperative echocardiographic trans-valve gradients varied among bioprosthesis manufacturers. The 25-mm Mitris (5.1 ± 2.7)/(2.6 ± 1.3 torr) had the lowest peak/mean gradient and the 27-mm Epic bioprosthesis had the highest (9.2 ± 3.7)/(4.6 ± 1.9 torr). Surgical valve opening area (SOA) varied with the 25-mm Mitris having the largest SOA (2.4 ± 0.15 cm2 ) followed by the 27-mm Mosaic (2.04 ± 0.23 cm2 ) and the 27-mm Epic (1.8 ± 0.27 cm2 ) valve. Bench device orthogonal internal diameter measurements did not match manufacturer device size labeling: 25-mm Mitris (23 × 23 mm), 27-mm Mosaic (23 × 22 mm), 27-mm Epic (21 × 21 mm). CONCLUSIONS: Current advertisement/packaging of commercial surgical mitral valves is not uniform. This study demonstrates marked variations in hemodynamics, valve opening area and anatomic dimensions between similar sized mitral bioprostheses. These data suggest a critical need for standardization and close scientific evaluation of surgical mitral bioprostheses to ensure optimal clinical outcomes.

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.

Triage considerations for patients referred for structural heart disease intervention during the COVID-19 pandemic: An ACC/SCAI position statement.

The coronavirus disease-2019 (COVID-19) pandemic has strained health care resources around the world, causing many institutions to curtail or stop elective procedures. This has resulted in an inability to care for patients with valvular and structural heart disease in a timely fashion, potentially placing these patients at increased risk for adverse cardiovascular complications, including CHF and death. The effective triage of these patients has become challenging in the current environment, as clinicians have had to weigh the risk of bringing susceptible patients into the hospital environment during the COVID-19 pandemic against the risk of delaying a needed procedure. In this document, the authors suggest guidelines for how to triage patients in need of structural heart disease interventions and provide a framework for how to decide when it may be appropriate to proceed with intervention despite the ongoing pandemic. In particular, the authors address the triage of patients in need of transcatheter aortic valve replacement and percutaneous mitral valve repair. The authors also address procedural issues and considerations for the function of structural heart disease teams during the COVID-19 pandemic.

Increased Risk of Perioperative Ischemic Stroke in Patients Who Undergo Noncardiac Surgery with Preexisting Atrial Septal Defect or Patent Foramen Ovale.

OBJECTIVES: To evaluate whether a preoperative diagnosis of atrial septal defect (ASD) or patent foramen ovale (PFO) is associated with perioperative stroke in noncardiac surgery and their outcomes. DESIGN: Retrospective cohort analysis. SETTING: United States hospitals. PARTICIPANTS: Adults patients (≥18 years old) who underwent major noncardiac surgery from 2010 to 2015 were identified using the Healthcare Cost and Utilization Project's National Readmission Database. INTERVENTIONS: Preoperative diagnosis of ASD or patent foramen ovale. MEASUREMENTS AND MAIN RESULTS: Among the 19,659,161 hospitalizations for major noncardiac surgery analyzed, 12,248 (0.06%) had a preoperative diagnosis of ASD/PFO. Perioperative ischemic stroke occurred in 723 (5.9%) of patients with ASD/PFO and 373,291 (0.02%) of those without ASD/PFO (adjusted odds ratio [aOR], 16.7; 95% confidence interval [CI]: 13.9-20.0). Amongst the different types of noncardiac surgeries, obstetric, endocrine, and skin and burn surgery were associated with higher risk of stroke in patients with pre-existing ASD/PFO. Moreover, patients with ASD/PFO also had an increased in-hospital mortality (aOR, 4.6, 95% CI: 3.6-6.0), 30-day readmission (aOR, 1.2, 95% CI: 1.04-1.38), and 30-day stroke (aOR, 7.2, 95% CI: 3.1-16.6). After adjusting for atrial fibrillation, ischemic stroke remained significantly high in the ASD/PFO group (aOR: 23.7, 95%CI 19.4-28.9), as well as in-hospital mortality (aOR: 5.6, 95% CI 4.1-7.7), 30-day readmission (aOR: 1.19, 95%CI 1.0-1.4), and 30-day stroke (aOR: 9.3, 95% CI 3.7-23.6). CONCLUSIONS: Among adult patients undergoing major noncardiac surgery, pre-existing ASD/PFO is associated with increased risk of perioperative ischemic stroke, in-hospital mortality, 30-day stroke, and 30-day readmission after surgery.