Transseptal Access Research Articles

Near zero fluoroscopy cryoballoon catheter ablation in patients with atrial fibrillation using a novel dielectric imaging system

Abstract Background Fluoroscopy is commonly used in cryoballoon catheter ablation for pulmonary vein (PV) isolation procedures in patients with atrial fibrillation (AF). Purpose The purpose of this study was to verify the feasibility of a new dielectric imaging system in reducing the radiation exposure during cryoballoon ablation in patients with AF. Methods We enrolled 40 consecutive patients with paroxysmal AF: 20 patients underwent the procedure under fluoroscopy guidance before the new system introduction, while 20 patient underwent the procedure under fluoroscopy and a new dielectric imaging system guidance with its occlusion tool software. After transseptal access a detailed image reconstruction of left atrium and PVs was achieved with an octapolar circular mapping catheter and the cryoablation was performed with a cryoballoon catheter. Results Total time of the procedure was comparable between the two groups (90.15±28.67 vs 80.77±17.17 using the dielectric imaging system, p=0.34), while fluoroscopy time was significantly lower in the group using the new dielectric imaging system (16.92±8.96 vs 5.54±2.06, p<0.01). Acute isolation was achieved in all PVs. No 30 days complication was observed. Conclusion This is the first study that demonstrates the feasibility of a reduce fluoroscopy workflow using the novel dielectric imaging system in a cryoballoon procedure. Funding Acknowledgement Type of funding source: None

Does the use of intracardiac echocardiography during atrial fibrillation catheter ablation improve outcomes and cost? A nationwide 14-year analysis from 2001 to 2014.

Intracardiac echocardiography (ICE) use during catheter ablation of atrial fibrillation (AF) provides real-time information to guide transseptal access, for monitoring the ablation and recognition of pericardial bleed. We describe trends of ICE use, impact on complications, and its in-hospital outcomes. The national in-patient sample database was queried from 2001 to 2014 for diagnosis of AF based on ICD-9-CM 427.31 with a catheter ablation procedure code (37.34) in the same hospitalization and its associated complications. ICE was identified using ICD-9-CM procedure code (37.28). Statistical Analysis System (SAS) was used for analysis. There was an estimated total 299,152 patients who underwent AF ablation from 2001 to 2014 of which ICE was used in 46,688 (15.6%) patients. The use of ICE significantly increased from 0.08% in 2001 to 15.7% in 2014. In-hospital mortality was significantly lower in patients in whom ICE was used (0.11% vs 0.54%, p < 0.0001). Complications were 52% lower in procedures using ICE vs without ICE (HR [95%CI]; 0.48 [0.44-0.51]). The rate of cardiac complications was also lower in ICE users (3.67% vs 4.51%; p = 0.025). The use of ICE during AF ablation resulted in significantly higher cost of hospitalization ($98,436 ± 597 vs $81,300 ± 310; p < 0.0001), but this was offset by a decreased length of hospital stay (2.1 ± 0.02 vs 4 ± 0.02days; p< 0.0001). The use of ICE during AF ablation has increased over the years and is associated with lower in-hospital mortality and procedural complications, shorter LOS but an increased cost of hospitalization.

One-Year Outcomes of Mitral Valve-in-Valve Using the SAPIEN 3 Transcatheter Heart Valve

Bioprosthetic mitral valves are implanted with increasing frequency but inevitably degenerate, leading to heart failure. Reoperation is associated with high morbidity and mortality. Transcatheter mitral valve-in-valve (MViV) using balloon-expandable transcatheter valves has emerged as an alternative for high-surgical risk patients. To assess contemporary outcomes of SAPIEN 3 (Edwards Lifesciences) MViV replacement. In this registry-based prospective cohort study of SAPIEN 3 MViV, patients entered in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from June 2015 to July 2019 were analyzed. US Centers for Medicare and Medicaid linkage ensured comprehensive collection of death and stroke data. Mitral valve-in-valve for degenerated bioprosthetic mitral valves. The primary efficacy end point was 1-year mortality. The primary safety end point was procedural technical success as defined by the Mitral Valve Academic Research Consortium criteria. Secondary end points included 30-day mortality, New York Heart Association-defined heart failure, and mitral valve performance. A total of 1529 patients (mean [SD] age, 73.3 [11.84] years; 904 women [59.1%]) underwent transseptal or transapical MViV implant at 295 hospitals between June 2015 and July 2019. The mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 11.1% (8.7%). Procedural technical success was achieved for 1480 of 1529 patients (96.8%). All-cause mortality was 5.4% at 30 days and 16.7% at 1 year. Transseptal access was associated with lower 1-year all-cause mortality than transapical access (15.8% vs 21.7%; P = .03). Transcatheter MViV led to early, sustained, and clinically meaningful improvements in heart failure (class III/IV New York Heart Association heart failure of 87.1% at baseline vs 9.7% at 1 year). The mean (SD) mitral valve gradient at 1 year was 7 (2.89) mm Hg. Transcatheter MViV using the SAPIEN 3 transcatheter heart valve is associated with high technical success, low 30-day and 1-year mortality, significant improvement of heart failure symptoms, and sustained valve performance. Transseptal MViV should be considered an option for most patients with failed surgical bioprosthetic valves and favorable anatomy.

Haemodynamics of an iatrogenic atrial septal defect after MitraClip implantation.

The MitraClip procedure requires transseptal access of the left atrium with a 24F guiding sheath. We evaluated invasively whether a MitraClip induced iatrogenic atrial septal defect (IASD) leads to development of a relevant interatrial shunt and right ventricular overload. A total of 69 patients who underwent a MitraClip procedure due to a severe mitral valve regurgitation (MVR) were included in the observational, retrospective cohort study. All pressures were directly measured throughout the procedure. Cardiac index (CI), systemic (Qs) and pulmonary (Qp) flow were calculated using the Fick method. Successful MitraClip implantation increased CI (2.5±0.62 vs 3.05±0.77L/min/m2 ; P<.0001), whereas SVR (1491±474 vs 997±301dyns/cm5 ; P<.0001), PVR (226±121 vs 188±96dyn/s/cm5 ; P=.04), PCWP (23±6.1 vs 20±4.7mmHg; P=.0031), PA pressure (33.6±7.2 vs 31.9±6.6mmHg; P=.1437) and LA pressure (21.5±5.4 vs 18.7±4.9mmHg; P<.0001) all decreased. The effect on LA pressure was further enhanced by guiding catheter retrieval (14.4±4.6mmHg; P<.0001). At the end of the procedure, Qp (6.033±1.3L/min) exceeded Qs (5.537±1.3L/min) by 0.496L/min leading to a Qp:Qs ratio of 1.09 (P=.007). After 6months, echocardiography revealed no changes in RV diameter (42.96±6.95mm vs 43.81±7.67mm; P=.62) and TAPSE (17.13±3.33mm vs 17.36±3.24mm; P=.48). Our data show that the MitraClip procedure does not induce a relevant interatrial shunt or right ventricular overload. In fact, future studies will have to show whether the IASD may even be beneficial in selected patient populations by left atrial volume and pressure relief.

Comparison between minimal fluoroscopy and conventional approaches for visually guided laser balloon pulmonary vein isolation ablation.

Although balloon-based techniques, such as the laser balloon (LB) ablation have simplified pulmonary vein isolation (PVI), procedural fluoroscopy usage remains higher in comparison to radiofrequency PVI approaches due to limited 3-dimensional mapping system integration. In this prospective study, 50 consecutive patients were randomly assigned in alternating fashion to a low fluoroscopy group (LFG;n = 25) or conventional fluoroscopy group (CFG;n = 25) and underwent de novo PVI procedures using visually guided LB technique. There was no statistical difference in baseline characteristics or cross-overs between treatment groups. Acute PVI was accomplished in all patients. Mean follow up was 318 ± 69 days. Clinical recurrence of atrial fibrillation after PVI was similar between groups (CFG: 19% vs LFG: 15%; P = .72). Total fluoroscopy time was significantly lower in the LFG than the CFG (1.7 ± 1.4 vs16.9 ± 5.9 minutes; P < .001) despite similar total procedure duration (143 ± 22vs148 ± 22 minutes; P = .42) and mean LA dwell time (63 ± 15vs59 ± 10 minutes; P = .28). Mean dose area product was significantly lower in the LFG (181 ± 125vs1980 ± 750 μGym2 ; P < .001). Fluoroscopy usage after transseptal access was substantially lower in the LFG (0.63 ± 0.43vs11.70 ± 4.32 minutes; P < .001). Complications rates were similar between both groups (4% vs2%; P = .57). This study demonstrates that LB PVI can be safely achieved using a novel low fluoroscopy protocol while also substantially reducing fluoroscopy usage and radiation exposure in comparison to conventional approaches for LB ablation.

P1006Cryo-balloon ablation in elderly; Outcome and prediction of recurrence

Abstract Background It is well known that prevalence of atrial fibrillation correlates with age, however the data on ablation of atrial fibrillation in elderly patients is poor. Aim of this study was analysis of outcome and prediction of recurrence after cryo-balloon ablation (CBA) in elderly patients based on available data in our registry. Methods The history of AF was assessed at admission. Additionally, all patients received echocardiographic examination and blood test. After a single trans-septal access and PV angiography PVI was performed using a 28-mm CBA. Mapping of PV signals before, during, and after each cryo application was performed with a 3F lasso catheter. The procedural endpoint after PVI was defined as complete elimination of all fragmented signals at the PV antrum with verification of entrance and exit block. Primary endpoint was first documented recurrence of AF, atrial tachycardia or atrial flutter (&amp;gt;30 sec.). All patients received a follow-up every 3 month within 1st year, once yearly thereafter and in case of symptoms. Seven days Holter ECG was recorded by every follow up. Results A total of 44 (39%) of enrolled patients were male, 48 (43%) suffered non- paroxysmal AF(nPAF), 93 (82%) had hypertension, CAD was diagnosed by 27 (24%), 28 (25%) had DM (Hb1AC &amp;gt; 6), Stroke/TIA was observed in 11 (10%). Median Age in elderly was 76 (75-78) y, BMI 25.77 (23.51-28.69), time since 1st diagnosis 40 (6-50) month, LA area index 11.36 (9.77-13.20), TAPSE 23 (19-26), GFR 74 (66-83) mL/min, LVEF 60 (57-62). A total of 44 patients (39%) reached endpoint within follow up of 20 (12-38) months. Univariate association with outcome was found by follows parameter: Time from 1st diagnosis &amp;gt; 3 y (HR = 3.22 (1.66-6.27), p=.001); LA area index (HR = 1.17 (1.03-1.32), p=.013); DM (HR = 1.89 (1.02-3.55), p=.042); nPAF (HR = 1.90 (1.04-3.47), p=.036). After multivariate analysis only time from 1st diagnosis &amp;gt; 3 y, (HR= 3.17 (1.62-6.16), p=.001 and nPAF (HR = 1.84 (1.01-3.36)), p=.048 were revealed to be predictive. The area under probability score calculated for these predictors was .731 (.638-8.25), p=.001. Follows complications were observed: 2 (2%) - pericard tamponades, 4 (4%) phrenicus nerve injury. Conclusion. PVI with cryo-balloon is effective for elderly patients providing freedom of arrhythmic events in 61% of patients. Longer history of AF over 3 years since 1st diagnosis was main predictor for post ablation recurrence. In elderly patients with shorter history of AF efficiency and safety of CBA is comparable with general population.

Fluoroless Atrial Fibrillation Catheter Ablation: Technique and Clinical Outcomes.

Fluoroscopy continues to be considered an indispensable part of atrial fibrillation (AF) ablation worldwide. Deleterious effects of radiation exposure to patients, physicians, and catheter laboratory personnel are gaining increased consideration. Safety and efficacy of a fluoroless approach for AF ablation is comparable with outcomes achieved with fluoroscopy use. This article focuses on AF ablation with zero fluoroscopy use as well as current evidence on efficacy and safety of this technique. In contrast, minimal fluoroscopy is an alternative. Relying on intracardiac echocardiography for transseptal access and electroanatomic mapping for catheter manipulation can help implement this approach on a wider scale.

General anesthesia during atrial fibrillation ablation: Standardized protocol and experience

Most atrial fibrillation (AF) ablations are performed with general anesthesia (GA). The ideal GA protocol is unknown, but it affects ablation outcomes and laboratory utilization. We sought to report a GA protocol used at a high-volume center, with special consideration on efficiency and optimization of mapping and ablation conditions. Our protocol consists of propofol as sole anesthetic agent and analgesia with Fentanyl. IV fluids are minimized. After transseptal access, the right phrenic nerve is tagged, rocuronium is given, and redosing avoided. Ventilation is modulated to optimize mapping and ablation. After ablation, isoproterenol is infused for 20min. After 10min, propofol is gradually decreased and ventilation set to SIMV 8 breaths/min to promote spontaneous breathing, and then switched to pressure support and propofol stopped. Paralysis is reversed and furosemide given. Patient is extubated once meeting standard criteria. A total of 1286 patients underwent AF ablation from January 2017 to December 2018 using the protocol. Mean age was 66 years (41% paroxysmal AF, CHADS2Vasc 2.6). Total procedure time was 86min. Median time to extubation was 9min (first and third quartile 6-16) after procedure completed, with total anesthesia time of 116min. On average 370mL of fluids were given by anesthesia. Only one patient who had heart failure required reintubation with no other anesthesia-related complications seen. Our GA protocol was specifically designed for AF ablation. It was safe and led to efficient recovery and extubation times. It maximizes laboratory utilization time without compromising safety.

Perforating the GORE® CARDIOFORM septal occluder and atrial septal defect occluder to gain access to the left atrium.

Perforate the expanded polytetrafluoroethylene membrane of the GORE® CARDIOFORM Septal Occluder (GSO) and GORE® CARDIOFORM ASD Occluder (GCA) after implantation. Percutaneous transseptal access to the left atrium is necessary for many structural and electrophysiological procedures. The potential need to access the left atrium may influence decision-making for patent foramen ovale or atrial septal defect closure. Sixteen canines underwent implantation of equal number GSO or GCA devices. A transseptal crossing procedure was performed through the device 85 (±1) days postoccluder implantation. The crossing procedure was performed utilizing commercially available equipment: radiofrequency/SureFlex sheath and standard needle/Mullin's sheath. Progressive dilation of the perforation was performed to allow passage of a 12 French Mullin's sheath into the left atrium. Left atrial access was achieved in all cases. Postmortem analysis demonstrated passage through both occluder discs in all radiofrequency/SureFlex sheath cases (4 GSO, 4 GCA) and half of the standard needle/Mullin's sheath cases (3 GSO, 1 GCA). The remaining standard needle/Mullin's sheath cases demonstrated perforation through the right atrial disc but passage around the septal aspect of the left atrial disc, thus not perforating the left atrial disc. No acute embolic complications from the procedure were observed. Left atrial access may be achieved through the GSO or GCA devices after implantation and endothelialization. The combination of a radiofrequency needle and steerable sheath provides benefit over a standard needle and Mullin's sheath in accomplishing passage through both occluder discs.

Safety and Effectiveness of a Novel Fluoroless Transseptal Puncture Technique for Lead-free Catheter Ablation: A Case Series

Increasing awareness of the health risks associated with the exposure of patients and staff in the catheterization laboratory to radiation has encouraged the pursuit of efforts to reduce the use of fluoroscopy during catheter ablation procedures. Although nonfluoroscopic guidance of ablation catheters has been previously described, transseptal access is still perceived as the last remaining barrier to completely fluoroless ablations. This study examined the safety and effectiveness of transseptal puncture and radiofrequency (RF) catheter ablation using a completely fluoroless approach. Three hundred eighty-two consecutive cases that had undergone completely nonfluoroscopic RF catheter ablation were evaluated. Ablation procedures were performed for atrial fibrillation, atrial flutter, atrioventricular reentry tachycardia, and pulmonary vein complex/ventricular tachycardia. Transseptal puncture and RF ablation were conducted under three-dimensional electroanatomic mapping and intracardiac echocardiography image guidance. Fluoroless transseptal puncture and catheter ablation were completed successfully in all cases, with no intraoperative complications. One patient required minimal use of fluoroscopy to visualize sheath advancement through an existing inferior vena cava filter. Procedural time was approximately 2.2 hours from transvenous access until case conclusion; transseptal access was obtained within 28 minutes of procedure initiation. Arrhythmia was found to recur in 27% of cases on average three months after the procedure. We demonstrate the safety and effectiveness of a completely fluoroless transseptal puncture and RF ablation technique that eliminates radiation exposure and enables complex electrophysiology procedures to be performed in a lead-free environment.

Use of an angioplasty wire in transseptal puncture: A new application of an old technique

ObjectiveWe wondered if a modification of the conventional transseptal puncture technique performed with an angioplasty wire could be useful in patients with contrast hypersensitivity or allergy-like reactions. MethodsThis study comprised our initial experience in 22 patients with atrial fibrillation who were scheduled for an electrophysiology study (EPS) and pulmonary vein ablation and who had a contraindication for iodinated contrast administration. ResultsOf the 22 patients, 16 were men and ages ranged from 27 to 74 years (mean 56 years). Overall successful transseptal access was achieved in all 22. A control echocardiogram was performed in all patients. There were no complications in any case and no significant differences were found from the conventional transseptal puncture technique regarding procedure or fluoroscopy time. ConclusionsA modification of the conventional transseptal puncture technique performed with fluoroscopy and EPS catheters for anatomical reference and an angioplasty wire is an option in cases with severe contrast hypersensitivity.

LONG-TERM OUTCOMES OF TRANSCATHETER MITRAL VALVE REPLACEMENT USING A BALLOON EXPANDABLE VALVE

Transcatheter mitral valve replacement (TMVR) using commercially available balloon expandable valves via a percutaneous, transseptal access has previously been reported but only short-term outcomes have been discussed. Long-term outcomes of this percutaneous strategy should be elucidated. From 1/

THE USE OF INTRACARDIAC ECHOCARDIOGRAPHY DURING ATRIAL FIBRILLATION ABLATION AND ITS IMPACT ON OUTCOMES: A 14-YEAR ANALYSIS (2001-2014)

Intracardiac echocardiography (ICE) during atrial fibrillation (AF) ablation offers real time information to guide transseptal access, monitoring the lesion and recognition of pericardial bleed. We describe the trends in the use of ICE and its impact on in-hospital outcomes and complications.

Transcatheter Aortic Valve Implantation: Transseptal Approach Using a Femoral Veno- Arterial Loop

After successful introduction of transcatheter aortic valve implantation (TAVI) in 2002, TAVI has become an increasingly accepted therapy for the treatment of severe aortic stenosis in patients judged to be at high risk for open heart surgery. We describe anterograde transseptal access for TAVI in a patient where transfemoral access alone was impossible to achieve due to a heavily calcified stenotic aortic valve. It is an interesting and alternative approach to achieve TAVI.

Catheter ablation of atrial fibrillation in afunctionally univentricular heart: arisk-adjusted interventional approach.

In adults with congenital heart disease, atrial fibrillation occurs at alower age due to the increased atrial stress compared to structurally normal hearts. The ablation target thus results from the underlying heart defect and the specific arrhythmia: in the case of atrial fibrillation, pulmonary vein isolation with left atrial substrate modification can be performed safely and effectively taking into account the individual cardiac lesion, which is often related to difficult transseptal access. This case is arepresentative example of catheter ablation of atrial fibrillation in apatient with afunctional univentricular heart using intracardiac echocardiography-guided double transseptal puncture.

Hemopericardium Following Transseptal Puncture During Balloon Mitral Valvotomy: Management Strategies and Outcomes.

Hemopericardium is a major complication of balloon mitral valvotomy (BMV). Only a few studies are available to address this issue following transseptal access. In addition, the management strategy regarding completion of BMV is uncertain. We sought to determine the incidence of hemopericardium complicating transseptal puncture during BMV. In addition, the management strategy adopted and outcomes are highlighted. This prospective study included 29 consecutive patients who developed hemopericardium following transseptal access during BMV. Out of 1424 patients who underwent BMV, hemopericardium developed in 29 patients following transseptal access (2.0%). The mean age of the study cohort was 36.9 ± 13.7 years and 82.8% were women. A second transseptal puncture was done and BMV was completed in 26 patients (89.6%). An acceptable hemodynamic result was obtained in 22 patients (84.6%). Six patients (20.7%) underwent emergency surgery for hemopericardium. The sites of perforation were inferior vena cava-right atrial junction in 4 cases, left atrial posterior wall in 1 case, and left atrial appendage in 1 case. In addition to repair of the perforation, a total of 2 patients underwent mitral valve replacement and 1 patient underwent open mitral commissurotomy. The in-hospital mortality rate was 6.9%. The incidence of hemopericardium complicating transseptal access during BMV was 2.0%, and was associated with a mortality rate of 6.9%. BMV can be safely performed in the same sitting with a second transseptal puncture, in patients with a favorable valve morphology. Surgical intervention can be reserved for a subset of patients with persistent pericardial collection.

Radiofrequency-Assisted Transseptal Access for Atrial Fibrillation Ablation Viaa SuperiorApproach.

This study describes the technique and outcomes of atrial fibrillation (AF) ablation via a superior approach in patients with interrupted or absent inferior vena cavas (IVCs). In patients with interrupted or absent IVCs, transseptal access cannot be obtained via standard femoral venous access. In these patients, alternative strategies are necessary to permit catheter ablation in the left atrium (LA). This study reports on the outcomes of AF ablation from a superior venous access with a radiofrequency (RF)-assisted transseptal puncture (TSP) technique. This study identified patients with interrupted or absent IVCs who underwent AF ablation via a superior approach at 2 ablation centers from 2010 to2019. Fifteen patients (mean age: 50.8 ± 11.2 years; 10 men; 10 with paroxysmal AF) with interrupted or absent IVCs underwent AF ablation with transseptal access via a superior approach. Successful TSP was performed either with a manually bent RF transseptal needle (early cases: n=4) or using a RF wire (late cases: n=11); this approach permitted LA mapping and ablation in all patients. Mean time required to perform single (n=8) or double (n=7) TSP was 16.1 ± 4.8min, and mean total procedure time was 227.9 ± 120.7min (fluoroscopy time: 57.0 ± 28.5min). LA mapping and ablation were successfully performed in all patients. In patients with AF undergoing catheter ablation and who had a standard transseptal approach via femoral venous approach is impossible due to anatomic constraints, RF-assisted transseptal access via a superior approach can be an effective alternative strategy to permit LA mapping and ablation.

Transcatheter Mitral Valve Replacement for Treating Native Mitral Valve Disease: Current Status.

Transcatheter mitral valve replacement is increasingly being used as a treatment for high-risk patients who have native mitral valve disease; however, no comprehensive studies on its effectiveness have been reported. We therefore searched the literature for reports on patients with native mitral valve disease who underwent transcatheter access treatment. We found 40 reports, published from September 2013 through April 2017, that described the cases of 66 patients (mean age, 71 ± 12 yr; 30 women; 30 patients with mitral stenosis, 34 with mitral regurgitation, and 2 mixed) who underwent transcatheter mitral valve replacement. We documented their baseline clinical characteristics, comorbidities, diagnostic imaging results, procedural details, and postprocedural results. Access was transapical in 41 patients and transseptal in 25. The 30-day survival rate was 82.5%. The technical success rate (83.3% overall) was slightly but not significantly better in patients who had mitral regurgitation than in those who had mitral stenosis. Transapical access procedures resulted in fewer valve-in-valve implantations than did transseptal access procedures (P=0.026). These current results indicate that transcatheter mitral valve replacement is feasible in treating native mitral disease. The slightly higher technical success rate in patients who had mitral regurgitation suggests that a valve with a specific anchoring system is needed when treating mitral stenosis. Our findings indicate that transapical access is more reliable than transseptal access and that securely anchoring the valve is still challenging in transseptal access.

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

To examine the safety of utilizing transapical access during structural interventions. 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. 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. 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. 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.

Transcatheter Mitral Valve Implantation (TMVI) Using Edwards SAPIEN 3 Prostheses in Patients at Very High or Prohibitive Surgical Risk: A Single-Center Experience.

Background Mitral valve surgery in patients with failing bioprosthesis, annuloplasty rings, or in patients with advanced mitral annular calcification (MAC) is associated with high morbidity and mortality rates. Percutaneous antegrade transseptal transcatheter mitral valve implantation (TMVI) has recently successfully been performed in those patients at high or prohibitive surgical risk, but data on patients treated by TMVI are sparse. This study sought to evaluate short- and midterm outcomes of patients treated by TMVI at our site in clinical practice. Methods and Results From October 2016 to February 2018, seven patients (six women and one man) at high or prohibitive surgical risk underwent TMVI at our site. Three procedures were performed as TMVI in failed mitral valve bioprostheses (TMVI-VIV, “valve-in-valve”), one procedure was performed as TMVI in a failed mitral annuloplasty ring (TMVI-R), and three procedures were performed as TMVI in advanced native mitral annular calcification (TMVI-MAC). Mean age of the population treated was 77 ± 8.1 years, and mean log EuroScore I was 39 ± 0.12%. In all patients, an Edwards SAPIEN 3 transcatheter heart valve was implanted under 3D-TOE and fluoroscopic guidance using a transvenous/transseptal access. Indication for TMVI was the presence of advanced heart failure symptoms in all patients (NYHA class III/IV). The predominant dysfunction of the mitral valve treated was severe regurgitation in 72% (n = 5) and severe stenosis in 29% (n = 2) of all patients. TMVI was technically successful in all procedures. Clinical success with functional improvement of at least one NYHA class after procedure compared with before procedure was also achieved in all patients. Median NYHA class improved significantly from 4 before procedure to 2 after TMVI (p=0.008). Mitral valve regurgitation was reduced to trace or mild in all but one patient, who showed moderate MR after TMVI-MAC. No patient-prosthesis mismatch or LVOT obstruction occurred after TMVI. Two patients underwent interventional ASD closure during the in-hospital course due to a large and persisting atrial septal defect after transseptal access. One patient underwent pacemaker implantation due to complete AV-block after TMVI. One patient died in hospital 12 days after the procedure due to severe hospital-acquired pneumonia and sepsis. In-hospital mortality rate was 14% (1/7) in this high-risk population. After hospital discharge, no death occurred and clinical improvement—according to NYHA functional class—remained stable during one-year follow-up. Conclusion In this small single-center series, TMVI appears promising for patients at high or prohibitive surgical risk with either failing mitral bioprostheses/annuloplasty rings or native mitral valve dysfunction in combination with advanced MAC. Gaining experience in TMVI and new valves will further improve safety and efficacy of this new treatment option.