Prospective validation of a risk score to predict pacemaker implantation after transcatheter aortic valve replacement.

INTRODUCTION: The need for pacemaker is a common complication after transcatheter aortic valve replacement (TAVR). We previously described the Emory Risk Score (ERS) to predict the need for new pacemaker implant (PPM) after TAVR. Metrics included in the score are a history of syncope, pre-existing RBBB, QRS duration ≥140 ms, and prosthesis oversizing ≥16%. To prospectively validate the previously described risk score. METHODS: We prospectively evaluated all patients without pre-existing pacemakers, ICD, or pre-existing indications for pacing undergoing TAVR with the Edwards SAPIEN 3 prosthesis at our institution from March 2019 to December 2020 (n = 661). Patients were scored prospectively; however, results were blinded from clinical decision-making. The primary endpoint was PPM at 30 days after TAVR. Performance of the ERS was evaluated using logistic regression, a calibration curve to prior performance, and receiver operating characteristic (ROC) analysis. RESULTS: A total of 48 patients (7.3%) had PPM after TAVR. A higher ERS predicted an increased likelihood of PPM (OR 2.61, 95% CI: 2.05-3.25 per point, p < 0.001). There was good correlation between observed and expected values on the calibration curve (slope = 1.04, calibration at large = 0.001). The area under the ROC curve was 0.81 (95% CI [0.74-0.88], p < 0.001). CONCLUSIONS: The ERS prospectively predicted the need for PPM in a serial, real-world cohort of patients undergoing TAVR with a balloon-expandable prosthesis, confirming findings previously described in retrospective cohorts. Notably, the prospective performance of the score was comparable with that of the initial cohorts. The risk score could serve as a framework for preprocedural risk stratification for PPM after TAVR.

Transcaval access for the emergency delivery of 5.0 liters per minute mechanical circulatory support in cardiogenic shock.

OBJECTIVES: The purpose of this study was to describe the feasibility and early outcomes of transcaval access for delivery of emergency mechanical circulatory support (MCS) in cardiogenic shock. BACKGROUND: Vascular access for implantation of MCS in patients with cardiogenic shock is often challenging due to peripheral arterial disease and vasoconstriction. Transcaval delivery of MCS may be an alternative. We describe a series of patients we implanted an Impella 5.0 device, on-table without CT planning, through a percutaneous transcaval access route. METHODS: Ten patients with progressive or refractory cardiogenic shock underwent Impella 5.0 implantation via transcaval access. Demographic, clinical and procedural variables and in-hospital outcomes were collected. RESULTS: All ten underwent emergency implantation of the 7 mm diameter Impella 5.0 device via transcaval access. Six were women, with median age of 55.5 years (range, 29-69). Cardiogenic shock was attributed to idiopathic nonischemic cardiomyopathy (n = 4), myocarditis (n = 2), ischemic cardiomyopathy (n = 2), heart transplant rejection (n = 1), and unknown etiology (n = 1). Median duration of support was 92.1 hr (range, 21.2-165.4). Seven (70%) survived to device explant, with six (60%) surviving to access port closure and discharge. Among survivors, five recovered heart function and one received destination therapy left ventricular assist device. CONCLUSIONS: Transcaval access is feasible for emergency nonsurgical implantation of the Impella 5.0 device in cardiogenic shock with small or diseased iliofemoral arteries. This allows early institution of higher-flow MCS than conventional femoral artery implantation of the 3.5 L Impella CP device, and enables a bridge-to-recovery or bridge-to-destination strategy.

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.

Safety of same-day discharge after uncomplicated, minimalist transcatheter aortic valve replacement in the COVID-19 era.

OBJECTIVES: We sought to evaluate the safety, efficacy and feasibility of same-day discharge after uncomplicated, minimalist TAVR. BACKGROUND: At the start of the COVID-19 pandemic, we created a same-day discharge (SDD) pathway after conscious sedation, transfemoral (minimalist) TAVR to help minimize risk of viral transmission and conserve hospital resources. Studies support that next-day discharge (NDD) for carefully selected patients following minimalist TAVR is safe and feasible. There is a paucity of data regarding the safety of SDD after TAVR. METHODS: In-hospital and 30 day outcomes of consecutive patients meeting pre-specified criteria for SDD after minimalist TAVR at our institution between March and July of 2020 were reviewed. Outcomes were compared to a NDD cohort from July 2018 through July 2020 that would have met SDD criteria. Primary endpoints were mortality, delayed pacemaker placement, stroke and cardiovascular readmission at 30 days. RESULTS: Twenty nine patients were discharged via the SDD pathway after TAVR. 128 prior NDD patients were identified who met all criteria for SDD. The STS scores were similar between the two groups (SDD 2.6% ±1.5 vs. NDD 2.3% ± 1.2). There were no deaths at 30 days in either group. There was no significant difference in delayed pacemaker placement (SDD 0% vs. NDD 0.8%, p > .99) or cardiovascular readmission (SDD 0% vs. NDD 5.5%, p = .35) at 30 days. CONCLUSIONS: Same day discharge following uncomplicated, minimalist TAVR in selected patients appears to be safe, achieving similar 30 day outcomes as a cohort of next day discharge patients.

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.

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.

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.

Transcatheter pledget-assisted suture tricuspid annuloplasty (PASTA) to create a double-orifice valve.

OBJECTIVES: Pledget-assisted suture tricuspid valve annuloplasty (PASTA) is a novel technique using marketed equipment to deliver percutaneous trans-annular sutures to create a double-orifice tricuspid valve. BACKGROUND: Tricuspid regurgitation is a malignant disease with high surgical mortality and no commercially available transcatheter solution in the US. METHODS: Two iterations of PASTA were tested using trans-apical or trans-jugular access in swine. Catheters directed paired coronary guidewires to septal and lateral targets on the tricuspid annulus under fluoroscopic and echocardiographic guidance. Guidewires were electrified to traverse the annular targets and exchanged for pledgeted sutures. The sutures were drawn together and knotted, apposing septal and lateral targets, creating a double orifice tricuspid valve. RESULTS: Twenty-two pigs underwent PASTA. Annular and chamber dimensions were reduced (annular area, 10.1 ± 0.8 cm2 to 3.8 ± 1.5 cm2 (naïve) and 13.1 ± 1.5 cm2 to 6.2 ± 1.0 cm2 (diseased); septal-lateral diameter, 3.9 ± 0.3 mm to 1.4 ± 0.6 mm (naïve) and 4.4 ± 0.4 mm to 1.7 ± 1.0 mm (diseased); and right ventricular end-diastolic volume, 94 ± 13 ml to 85 ± 14 ml (naïve) and 157 ± 25 ml to 143 ± 20 ml (diseased)). MRI derived tricuspid regurgitation fraction fell from 32 ± 12% to 4 ± 5%. Results were sustained at 30 days. Pledget pull-through force was five-fold higher (40.6 ± 11.7N vs 8.0 ± 2.6N, P < .01) using this strategy compared to single puncture techniques used to anchor current investigational devices. Serious complications were related to apical access. CONCLUSIONS: PASTA reduces annular dimensions and tricuspid regurgitation in pigs. It may be cautiously applied to selected patients with severe tricuspid regurgitation and no options. This is the first transcatheter procedure, to our knowledge, to deliver standard pledgeted sutures to repair cardiac pathology.

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.

Long or redundant leaflet complicating transcatheter mitral valve replacement: Case vignettes that advocate for removal or reduction of the anterior mitral leaflet.

Transcatheter mitral valve replacement (TMVR) procedures can be an alternative to surgical valve replacement for high surgical risk patients with bioprosthetic mitral valves, annuloplasty rings, or severe mitral annular calcification (MAC). TMVR can trigger acute left ventricular outflow tract (LVOT) obstruction from permanent displacement of the native anterior mitral leaflet toward the left ventricular septum, more often among patients undergoing valve-in-ring and valve-in-MAC procedures. Although acute LVOT obstruction is well described in the literature, there are important additional complications of TMVR related to the length and/or redundancy of the anterior mitral valve that have been recognized after mitral valve surgery and have not been previously reported in the setting of TMVR. These additional complications include acute mitral regurgitation secondary to prolapsing native leaflet through the TMVR, frozen TMVR leaflet secondary to overhanging native leaflet and late LVOT obstruction in the neo-LVOT secondary to long native leaflet. Preprocedural planning with imaging (echocardiography and computed tomography) and measurement of anterior mitral leaflet length is critical important in understanding the risk for these complications. As transcatheter mitral valve technology proliferates, interactions with the anterior mitral leaflet after TMVR may be more frequent than initially anticipated. We believe that there is no advantage to an intact anterior leaflet and advocate removal or reduction of the leaflet prior to TMVR. © 2017 Wiley Periodicals, Inc.

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.

How to perform transcaval access and closure for transcatheter aortic valve implantation.

Transcaval, or caval-aortic, access is a promising approach for fully percutaneous transcatheter aortic valve implantation in patients without good conventional access options. This tutorial review provides step-by-step guidance to planning and executing the procedure, along with approaches to remedy complications.

Transcaval access for TAVR across a polyester aortic graft.

Transcaval access to the aorta allows transcatheter aortic valve replacement in patients without other good access options. The resulting aorto-caval fistula is closed with a nitinol cardiac occluder device. There is no experience traversing a synthetic aortic graft to perform transcaval access and closure. We describe a patient who underwent successful traversal of a polyester aortic graft using radiofrequency energy applied from the tip of a guidewire, to allow retrograde transcatheter aortic valve replacement from a femoral vein, along with details of our technique. The patient did well and was discharged home after 3 days. There was residual aorto-caval fistulous flow immediately after implantation of a polyester-seeded nitinol muscular ventricular septal defect occluder device, but this fistula spontaneously occluded within one month.

Intentional right atrial exit for microcatheter infusion of pericardial carbon dioxide or iodinated contrast to facilitate sub-xiphoid access.

OBJECTIVES: We test the safety of transatrial pericardial access using small catheters, infusion of carbon dioxide (CO2 ) or iodinated contrast to facilitate sub-xiphoid access, and catheter withdrawal under full anticoagulation. BACKGROUND: Sub-xiphoid pericardial access is required for electrophysiological and structural heart interventions. If present, an effusion protects the heart from needle injury by separating the myocardium from the pericardium. However, if the pericardium is 'dry' then there is a significant risk of right ventricle or coronary artery laceration caused by the heart beating against the needle tip. Intentional right atrial exit is an alternative pericardial access route, through which contrast media could be infused to separate pericardial layers. METHODS: Transatrial pericardial access was obtained in a total of 30 Yorkshire swine using 4Fr or 2.8Fr catheters. In 16 animals, transatrial catheters were withdrawn under anticoagulation and MRI was performed to monitor for pericardial hemorrhage. In 14 animals, iodinated contrast or CO2 was infused before sub-xiphoid access was obtained. RESULTS: Small effusions (mean 18.5 ml) were observed after 4Fr (1.3 mm outer-diameter) but not after 2.8Fr (0.9 mm outer-diameter) transatrial catheter withdrawal despite full anticoagulation (mean activated clotting time 383 sec), with no hemodynamic compromise. Pericardial CO2 resorbed spontaneously within 15 min. CONCLUSIONS: Intentional transatrial exit into the pericardium using small catheters is safe and permits infusion of CO2 or iodinated contrast to separate pericardial layers and facilitate sub-xiphoid access. This reduces the risk of right ventricular or coronary artery laceration. 2.8Fr transatrial catheter withdrawal does not cause any pericardial hemorrhage, even under full anticoagulation.

Left Ventricular Outflow Tract Modification for Transcatheter Mitral Valve Replacement.

Left ventricular outflow tract (LVOT) obstruction is a life-threatening complication of transcatheter mitral valve replacement. In-depth analysis of pre-procedural computed tomography enables accurate prediction of this risk. Several techniques for LVOT modification, including Laceration of the Anterior Mitral leaflet to Prevent Outflow ObtructioN, preemptive alcohol septal ablation, preemptive radiofrequency ablation, and Septal Scoring Along the Midline Endocardium, have been described as effective strategies to mitigate this risk. This review aims to explore the indications, procedural steps, and outcomes associated with these LVOT modification techniques.

Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms (VINTAGE): Deep Ablation in Inaccessible Targets.

BACKGROUND: Deep intramural ventricular tachycardia substrate targets are difficult to access, map, and ablate from endocardial and epicardial surfaces, resulting in high recurrence rates. OBJECTIVES: In this study, the authors introduce a novel approach called ventricular intramyocardial navigation for tachycardia ablation guided by electrograms (VINTAGE) to access and ablate anatomically challenging ventricular tachycardia from within the myocardium. METHODS: Guidewire/microcatheter combinations were navigated deep throughout the extravascular myocardium, accessed directly from the right ventricle cavity, in Yorkshire swine (6 naive, 1 infarcted). Devices were steered to various intramyocardial targets including the left ventricle summit, guided by fluoroscopy, unipolar electrograms, and/or electroanatomic mapping. Radiofrequency ablations were performed to characterize ablation parameters and reproducibility. Intramyocardial saline irrigation began 1 minute before ablation and continued throughout. Lesions were analyzed on cardiac magnetic resonance and necropsy. RESULTS: VINTAGE was feasible in all animals within naive and infarcted myocardium. Forty-three lesions were created, using various guidewires and power settings. Forty-one (95%) lesions were detected on cardiac magnetic resonance and 38 (88%) on necropsy; all undetected lesions resulted from intentionally subtherapeutic ablation energy (10 W). Larger-diameter guidewires yielded larger size lesions. Lesion volumes on necropsy were significantly larger at 20 W than 10 W (178 mm3 [Q1-Q3: 104-382 mm3] vs 49 mm3 [Q1-Q3: 35-93 mm3]; P = 0.02). Higher power (30 W) did not create larger lesions. Median impedance dropped with preablation irrigation by 12 Ω (Q1-Q3: 8-17 Ω), followed by a further 15-Ω (Q1-Q3: 11-19 Ω) drop during ablation. Intramyocardial navigation, ablation, and irrigation were not associated with any complications. CONCLUSIONS: VINTAGE was safe and effective at creating intramural ablation lesions in targets traditionally considered inaccessible from the endocardium and epicardium, both naive and infarcted. Intramyocardial guidewire irrigation and ablation at 20 W creates reproducibly large intramural lesions.

TABERNACL: Temporary Hemodynamic Stabilization In Vivo.

BACKGROUND: Acute aortic regurgitation is life-threatening with few nonsurgical options for immediate stabilization. We propose Trans-Aortic Balloon to Ease Regurgitation Applying Counter-Pulsation (TABERNACL), a simple, on-table temporary valve using commercially available equipment to temporize acute severe aortic regurgitation. METHODS: We hypothesize that an appropriately sized commercial balloon dilatation catheter-straddling the aortic annulus and connected to a counterpulsation console-can serve as a temporizing valve to restore hemodynamic stability in acute aortic regurgitation. We performed benchtop testing of valvuloplasty, angioplasty, and sizing balloons as counterpulsation balloons. TABERNACL was assessed in vivo in a porcine model of acute aortic regurgitation (n=8). We also tested a static undersized, continuously inflated transvalvular balloon as a spacer intended physically to obstruct the regurgitant orifice. RESULTS: Benchtop testing identified that Tyshak II and PTS sizing (NuMed Braun) balloon catheters performed adequately as temporary valves (ie, complete inflation and deflation with each cycle) and resisted fatigue, in contrast to others. When TABERNACL was used in the acute severe regurgitation animals, there was immediate hemodynamic improvement, with a significant 35% increase in diastolic aortic pressure by 16 mm Hg ([95% CI, 7-25] P=0.0056), 34% reduction in left ventricular end-diastolic pressure by -7 mm Hg ([95% CI, -10 to -5] P=0.0006), improvement in the aortic diastolic index by 0.28 ([95% CI, 0.18-0.39] P=0.0009), and reversal of electrocardiographic myocardial ischemia. As an alternative, static balloon inflation across the aortic valve stabilized regurgitation hemodynamics at the expense of a new aortic gradient and caused excessive ectopy from balloon movement in the left ventricular outflow tract. CONCLUSIONS: TABERNACL improves hemodynamics and reduces coronary ischemia by electrocardiography in animals with acute severe aortic regurgitation. TABERNACL valves obstruct the diastolic regurgitant orifice without systolic obstruction. This may prove a lifesaving bridge to definitive valve replacement therapy.

Transcatheter Paravalvular Leak Closure With Covered Stent Tract and Vascular Plug: Tootsie Roll Technique.

BACKGROUND: Transcatheter closure of transcatheter heart valve (THV)-related paravalvular leak (PVL) is associated with a high failure rate with available devices due to the complex interaction of THV and aortic/mitral annulus. OBJECTIVES: This study reports on novel transcatheter techniques to treat PVL after THV. METHODS: The authors describe consecutive patients who underwent PVL closure after transcatheter aortic valve replacement (TAVR) or transcatheter mitral valve replacement (TMVR). A covered self-expanding stent (Viabahn) was deployed in the defect to create a seal between the THV and annulus. A vascular plug (Amplatzer Vascular Plug 2 [AVP2] or AVP4) was then deployed inside the covered stent to obliterate PVL. RESULTS: Eight patients with THV-related PVL were treated using this method (aortic [3 SAPIEN, 1 Evolut], mitral [2 SAPIEN-in-MAC (mitral annular calcification), 2 M3 TMVR). Various combinations of stents and plugs were used (5 mm × 2.5 cm Viabahn + 6 mm AVP4 [n = 2], 8 mm × 2.5 cm Viabahn + 10 mm AVP2 [n = 5], and 10 mm × 5.0 cm Viabahn + 12 mm AVP2 [n = 1]). All had technical success with immediate elimination of target PVL, without in-hospital complications. None had signs of postprocedure hemolysis. All patients were discharged alive (median 3.5 days [Q1-Q3: 1.0-4.8 days]). No residual PVL was seen at discharge, except for 1 patient with mild regurgitation due to another untreated PVL location. One patient died before 30 days due to complication of valve-in-MAC TMVR. In remaining patients, none had recurrence of PVL at 30 days. Symptoms decreased to NYHA functional class I/II in 6 patients. NYHA functional class III symptoms remained in 1 patient with mitral regurgitation awaiting subsequent valve replacement procedure. CONCLUSIONS: The technique of sequential deployment of a covered stent and vascular plug may effectively treat THV-related PVL.