Left atrial to coronary sinus shunting for treatment of heart failure with mildly reduced or preserved ejection fraction: The ALT FLOW Early Feasibility Study 1-year results.

AIMS: Patients with heart failure and mildly reduced or preserved ejection fraction have limited therapeutic options. The ALT-FLOW Early Feasibility Study evaluated safety, haemodynamics and outcomes for the APTURE transcatheter shunt system, a novel left atrium to coronary sinus shunt in these patients. METHODS AND RESULTS: Safety and shunt implantation success was evaluated for all 116 enrolled patients. An analysis population of implanted patients with a left ventricular ejection fraction (LVEF) >40% (n = 95) was chosen to assess efficacy via paired comparison between baseline and follow-up haemodynamic (3 and 6 months), and echocardiographic, clinical and functional outcomes (6 months and 1 year). Health status and quality of life outcomes were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS). The primary safety endpoint, major adverse cardiac, cerebral, and renal events, and reintervention through 30 days, occurred in 3/116 patients (2.6%). All implanted shunts were patent at 1 year. In patients with LVEF >40%, the mean (95% confidence interval) reduction in exercise pulmonary capillary wedge pressure (PCWP) at 20 W was -5.7 (-8.6, -2.9) mmHg at 6 months (p < 0.001). At baseline, 8% had New York Heart Association class I-II status and improved to 68% at 1 year (p < 0.001). KCCQ-OSS at baseline was 39 (35, 43) and improved at 6 months and 1 year by 25 (20-30) and 27 (22-32) points, respectively (both p < 0.0001). No adverse changes in haemodynamic and echocardiographic indices of right heart function were observed at 1 year. Overall, the reduction in PCWP at 20 W and improvement in KCCQ-OSS in multiple subgroups were consistent with those observed for the entire population. CONCLUSIONS: In patients with heart failure and LVEF >40%, the APTURE shunt demonstrated an acceptable safety profile with significant sustained improvements in haemodynamic and patient-centred outcomes, underscoring the need for further evaluation of the APTURE shunt in a randomized trial.

One-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation.

BACKGROUND: The CLASP IID (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical) trial is the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive risk patients with significant symptomatic degenerative mitral regurgitation (DMR). OBJECTIVES: The study sought to report primary and secondary endpoints and 1-year outcomes for the full cohort of the CLASP IID trial. METHODS: Prohibitive-risk patients with 3+/4+ DMR were randomized 2:1 (PASCAL:MitraClip). One-year assessments included secondary effectiveness endpoints (mitral regurgitation [MR] ≤2+ and MR ≤1+), and clinical, echocardiographic, functional, and quality-of-life outcomes. Primary safety (30-day composite major adverse events [MAE]) and effectiveness (6-month MR ≤2+) endpoints were assessed for the full cohort. RESULTS: Three hundred patients were randomized (PASCAL: n = 204; MitraClip: n = 96). At 1 year, differences in survival, freedom from heart failure hospitalization, and MAE were nonsignificant (P > 0.05 for all). Noninferiority of the PASCAL system compared with the MitraClip system persisted for the primary endpoints in the full cohort (For PASCAL vs MitraClip, the 30-day MAE rates were 4.6% vs 5.4% with a rate difference of -0.8% and 95% upper confidence bound of 4.6%. The 6-month MR≤2+ rates were 97.9% vs 95.7% with a rate difference of 2.2% and 95% lower confidence bound (LCB) of -2.5%, for, respectively). Noninferiority was met for the secondary effectiveness endpoints at 1 year (MR≤2+ rates for PASCAL vs MitraClip were 95.8% vs 93.8% with a rate difference of 2.1% and 95% LCB of -4.1%. The MR≤1+ rates were 77.1% vs 71.3% with a rate difference of 5.8% and 95% LCB of -5.3%, respectively). Significant improvements in functional classification and quality of life were sustained in both groups (P <0.05 for all vs baseline). CONCLUSIONS: The CLASP IID trial full cohort met primary and secondary noninferiority endpoints, and at 1 year, the PASCAL system demonstrated high survival, significant MR reduction, and sustained improvements in functional and quality-of-life outcomes. Results affirm the PASCAL system as a beneficial therapy for prohibitive-surgical-risk patients with significant symptomatic DMR.

Transcatheter Aortic Valve Replacement Outcomes in End-Stage Renal Disease Patients on Hemodialysis Requiring Midodrine.

Background: Patients with dialysis-dependent end-stage renal disease (ESRD) taking midodrine may be at high risk for poor outcomes following transcatheter aortic valve replacement (TAVR). We evaluated dialysis-dependent ESRD patients taking midodrine. Methods: We conducted a retrospective analysis of non-clinical trial TAVR patients from February 2012 to December 2020 from 11 facilities in a Western US health system. Patient groups included ESRD patients on midodrine before TAVR (ESRD [+M]), ESRD patients without midodrine (ESRD [-M]), and non-ESRD patients. The endpoints of 30-day and 1-year mortality were represented by Kaplan-Meier survival estimator and compared by log-rank test. Results: Forty-five ESRD (+M), 216 ESRD (-M), and 6898 non-ESRD patients were included. ESRD patients had more comorbid conditions, despite no significant difference in predicted Society of Thoracic Surgeons mortality risk between ESRD (+M) and ESRD (-M) (8.7% vs. 9.2%, p = 0.491). Thirty-day mortality was significantly higher for ESRD (+M) patients vs. ESRD (-M) patients (20.1% vs. 5.6%, p = 0.001) and for ESRD (+M) vs. non-ESRD patients (2.5%, p < 0.001). One-year mortality trended higher for ESRD (+M) vs. ESRD (-M) patients (41.9% vs. 29.8%, p = 0.07), and was significantly higher for ESRD (+M) vs. non-ESRD patients (10.7%, p < 0.001). Compared to ESRD (-M), ESRD (+M) patients had a higher incidence of 30-day stroke (6.7% vs. 1.4%, p = 0.033), 30-day vascular complications (6.7% vs. 0.9%, p = 0.011), and a lower rate of discharge to home (62.2% vs. 84.7%, p < 0.001). In contrast, ESRD (-M) patients had no significant differences from non-ESRD patients for these outcomes. Conclusions: Our experience suggests ESRD patients on midodrine are a higher acuity population with worse survival after TAVR, compared to ESRD patients not on midodrine. These findings may help with risk stratification for ESRD patients undergoing TAVR.

Left Atrial to Coronary Sinus Shunting for Treatment of Symptomatic Heart Failure.

BACKGROUND: Heart failure (HF) is associated with both mortality and a significant decline in health status. Interatrial shunting is increasingly being investigated as a novel therapeutic option. OBJECTIVES: The ALT FLOW Early Feasibility Study was designed to evaluate the safety of the Edwards left atrial to coronary sinus APTURE Transcatheter Shunt System in patients with symptomatic HF. METHODS: A total of 18 centers enrolled patients with symptomatic HF with a pulmonary capillary wedge pressure >15 mm Hg at rest or 25 mm Hg during exercise. RESULTS: Between May 2018 and September 2022, 87 patients underwent attempted APTURE shunt implantation. Mean age was 71 years, and 53% were male. At baseline, mean left ventricular ejection fraction was 59% with 90% of the patients being in NYHA functional class III. Device success was achieved in 78 patients (90%), with no device occlusions or associated adverse events identified after implantation. The primary safety outcome occurred in only 2 patients (2.3%) at 30 days. At 6 months, health status improved: 67% of participants achieved NYHA functional class I to II status, with a 23-point improvement (P < 0.0001; 95% CI: 17-29 points) in the Kansas City Cardiomyopathy Questionnaire overall summary score. Also at 6 months, 20-W exercise pulmonary capillary wedge pressure was 7 mm Hg lower (P < 0.0001; 95% CI: -11 to -4 mm Hg) without change in right atrial pressure or other right heart function indices. CONCLUSIONS: In this single-arm experience, the APTURE Transcatheter Shunt System in patients with symptomatic HF was observed to be safe and resulted in reduction in pulmonary capillary wedge pressure and clinically meaningful improvements in HF symptoms and quality of life indices.

Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.

BACKGROUND: Severe symptomatic degenerative mitral regurgitation (DMR) has a poor prognosis in the absence of treatment, and new transcatheter options are emerging. OBJECTIVES: The CLASP IID (Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial) randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared with the MitraClip system in patients with significant symptomatic DMR. This report presents the primary safety and effectiveness endpoints for the trial. METHODS: Patients with 3+ or 4+ DMR at prohibitive surgical risk were assessed by a central screening committee and randomized 2:1 (PASCAL:MitraClip). Study oversight also included an echocardiography core laboratory and a clinical events committee. The primary safety endpoint was the composite major adverse event rate at 30 days. The primary effectiveness endpoint was the proportion of patients with mitral regurgitation (MR) ≤2+ at 6 months. RESULTS: A prespecified interim analysis in 180 patients demonstrated noninferiority of the PASCAL system vs the MitraClip system for the primary safety and effectiveness endpoints of major adverse event rate (3.4% vs 4.8%) and MR ≤2+ (96.5% vs 96.8%), respectively. Functional and quality-of-life outcomes significantly improved in both groups (P < 0.05). The proportion of patients with MR ≤1+ was durable in the PASCAL group from discharge to 6 months (PASCAL, 87.2% and 83.7% [P = 0.317 vs discharge]; MitraClip, 88.5% and 71.2% [P = 0.003 vs discharge]). CONCLUSIONS: The CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met noninferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR.

Clinical Factors and Outcomes When Real-World Heart Teams Overruled STS Risk Scores in TAVR Cases.

Objectives: This study was conducted to determine why heart teams recommended transcatheter aortic valve replacement (TAVR) versus surgical AVR (SAVR) for patients at low predicted risk of mortality (PROM) and describe outcomes of these cases. Background: Historically, referral to TAVR was based predominately on the Society of Thoracic Surgeons (STS) risk model's PROM >3%. In selected cases, heart teams had latitude to overrule these scores. The clinical reasons and outcomes for these cases are unclear. Methods: Retrospective data were gathered for all TAVR and SAVR cases conducted by 9 hospitals between 2013 and 2017. Results: Cases included TAVR patients with STS PROM >3% (n = 2,711) and ≤3% (n = 415) and SAVR with STS PROM ≤3% (n = 1,438). Leading reasons for recommending TAVR in the PROM ≤3% group were frailty (57%), hostile chest (22%), severe lung disease (16%), and morbid obesity (13%), and 44% of cases had multiple reasons. Most postoperative and 30-day outcomes were similar between TAVR groups, but the STS PROM ≤3% group had a one-day shorter length of stay (2.5 ± 3.4 vs. 3.5 ± 4.7 days; p ≤ 0.001) and higher one-year survival (91.6% vs. 86.0%, p=0.002). In patients with STS PROM ≤3%, 30-day mortality was higher for TAVR versus SAVR (2.0% vs. 0.6%; p < 0.001). Conclusions: Heart teams recommended TAVR in patients with STS PROM ≤3% primarily due to frailty, hostile chest, severe lung disease, and/or morbid obesity. Similar postoperative outcomes between these patients and those with STS PROM >3% suggest that decisions to overrule STS PROM ≤3% were merited and may have reduced SAVR 30-day mortality rate.

Comparison of 26-mm Evolut and 23-mm Sapien 3 Valves in TAVR for Small Aortic Annulus.

BACKGROUND: Patients with small aortic annuli (SAA) are prone to higher post-transcatheter aortic valve replacement (TAVR) transvalvular gradients and development of prosthesis-patient mismatch (PPM). In many patients with SAA, the choice of TAVR valve commonly involves choosing between the 26-mm Medtronic Evolut 2 (ME26) or the 23-mm Edwards Sapien 3 valve (ES23). We compared echocardiographic and clinical outcomes in patients with SAA undergoing TAVR with either valve. METHODS: We queried the Providence St. Joseph Health Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry database for patients undergoing TAVR with either the ES23 or ME26 between July 2015 and December 2018 at 11 hospitals. Post-TAVR echocardiographic and clinical results in-hospital, at 1 month, and at 1 year were examined. High gradient (HG) was defined as mean gradient (MG) ≥20 mm Hg. RESULTS: We identified 1162 patients with SAA undergoing TAVR with either the ME26 (n = 233) or ES23 valve (n = 929). Baseline characteristics between groups were similar. At 1 month, the ME26 was associated with a lower MG than the ES23 (7.7 ± 4.7 mm Hg vs 13.1 ± 4.9 mm Hg; P<.001) and moderate or severe PPM (11% and 3% vs 27% and 13%; P<.001). Occurrence of HG at 1 year was lower with the ME26 valve vs the ES23 valve (0% vs 15%; P<.001). In-hospital and follow-up clinical outcomes to 1 year were similar for both groups. CONCLUSION: TAVR in SAA with the ME26 is associated with lower incidence of HG or PPM compared with the ES23. While clinical outcomes at 1 year were similar, the long-term implications of these findings remain unknown.

Transcatheter edge-to-edge repair of the tricuspid valve: The US experience.

OBJECTIVES: To examine the trends in utilization and outcomes of tricuspid valve (TV) transcatheter edge-to-edge repair (TEER). BACKGROUND: Surgery for isolated tricuspid regurgitation is associated with high morbidity and mortality and is rarely performed. TV TEER is an attractive alternative. METHODS: The Nationwide Readmissions Database was queried using the International Classification of Diseases, 10th Revision, procedure code for TV TEER for years 2016-2019. The main outcomes were trends in utilization and in-hospital all-cause mortality. RESULTS: We identified 918 hospitalizations for TV TEER. There was an uptrend in its utilization from 13 cases in the first quarter of 2016 to 122 cases in the last quarter of 2019 (p trend < 0.001). Concomitant mitral valve (MV) TEER was performed in 42.1% of admissions. The overall in-hospital mortality was 2.1%. Surgical TV replacement was needed in 1.1% of admissions; none of them died during the index hospitalization. Unplanned rehospitalizations were common at 30 days (15.7%); 38.2% of those were due to heart failure. There was no difference in in-hospital mortality between isolated TV TEER and combined MV and TV TEER (1.7% vs. 2.6%, p = 0.359). However, admissions receiving combined procedure had lower length of stay and urgent readmission rate. CONCLUSION: The current study showed that there was an increase in the utilization of TV TEER over 2016-2019 in the United States. TV TEER was associated with low rates of in-hospital mortality; however, the rate of urgent readmission remains high, mainly due to heart failure.

Transcatheter Closure of Large Atrial Septal Defects in Adults.

OBJECTIVE: To examine the outcomes of percutaneous closure of large atrial septal defects (ASDs) (≥25 mm). BACKGROUND: Data on long-term results after closure of large ASDs are limited. METHODS: We reviewed the records of 275 consecutive patients who underwent transcatheter closure of large (≥25 mm) ASDs from January 1999 until December 2016 in our center. The most common indication for closure was a large left-to-right shunt. Follow-up (FU) was performed at regular intervals thereafter. Results after closure of ASDs with diameters of 25-30 mm, >30-35 mm and >35 mm were compared. RESULTS: Percutaneous closure was technically successful in 99.6%. Mean FU time was 4.8 years (0-15.5 years). Peri-operative (30-day) adverse events occurred in 20.4% and included death in 0.7% (one unrelated to the procedure and one of unknown cause), device erosion in 0.7%, device embolization in 2.9%, pericardial effusion in 5.5%, air embolism in 0.4%, new onset atrial fibrillation in 10.5%, transient supraventricular tachycardia in 0.4% and fever in 0.7%. Late (>30 days after the procedure) atrial fibrillation occurred in 5.8%. There was one device erosion >15 years after the implantation treated successfully surgically. Complete defect closure was achieved in 95.6%. CONCLUSION: Device closure of large ASDs is feasible, safe and effective with high technical success and low risk of serious periprocedural complications. Nevertheless, in very large defects (>40 mm), both options, surgery and percutaneous closure should be considered. Device or procedural long-term adverse events are rare.

Outcomes of transcatheter versus surgical aortic valve replacement among solid organ transplant recipients.

BACKGROUND: There is a paucity of data regarding the outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) among solid-organ transplant recipients. METHODS: Temporal trends in hospitalizations for aortic valve replacement among solid-organ transplant recipients were determined using the National Inpatient Sample database years 2012-2017. Propensity matching was conducted to compare admissions who underwent TAVR versus SAVR. The primary outcome was in-hospital mortality. RESULTS: The analysis included 1,730 hospitalizations for isolated AVR; 920 (53.2%) underwent TAVR and 810 (46.7%) underwent SAVR. TAVR was increasingly utilized for solid-organ transplant recipients (Ptrend = 0.01), while there was no change in the number of SAVR procedures (Ptrend = 0.20). The predictors of undergoing TAVR for solid-organ transplant recipients included older age, diabetes, and prior coronary artery bypass surgery, while TAVR was less likely utilized in small-sized hospitals. TAVR was associated with lower in-hospital mortality after matching (0.9 vs. 4.7%, odds ratio [OR] 0.19; 95% confidence interval [CI] 0.11-0.35, p < .001) and after multivariable adjustment (OR 0.07; 95% CI 0.03-0.21, p < .001). TAVR was associated with lower rate of acute kidney injury, acute stroke, postoperative bleeding, blood transfusion, vascular complications, discharge to nursing facilities, and shorter median length of hospital stay. There was no difference between both groups in the use of mechanical circulatory support, hemodialysis, arrhythmias, or pacemaker insertion. CONCLUSION: This contemporary observational nationwide analysis showed that TAVR is increasingly performed among solid-organ transplant recipients. Compared with SAVR, TAVR was associated with lower in-hospital mortality, complications, and shorter length of stay.

Post-Market Clinical Follow-Up With the Patent Foramen Ovale Closure Device IrisFIT (Lifetech) in Patients With Stroke, Transient Ischemic Attack, or Other Thromboembolic Events.

BACKGROUND: A patent foramen ovale (PFO) has been associated with embolic strokes and transient ischemic attacks (TIAs). Catheter closure of PFO is effective in preventing recurrent events. Residual shunts and procedure or device related complications can occur, including atrial fibrillation and thrombus formation. This study examines the initial experience with a new PFO closure device, the IrisFIT PFO-Occluder (Lifetech Scientific, Shenzhen, China). METHODS: 95 patients with indications for PFO closure underwent percutaneous closure with the IrisFIT PFO-Occluder. The primary endpoint was the rate of accurate device placement with no/small residual shunt at 3 or 6 months follow-up. All patients underwent transoesophageal echocardiography (TEE) after 1 to 6 months. In case of a residual shunt, an additional TEE was performed after 12 months. Clinical follow-up was performed up to a mean of 33.1 ± 3.6 months. RESULTS: The device was successfully implanted in 95 (100%) patients with no relevant procedural complications. At final TEE follow-up (7.6 ± 3.9 months) the effective closure rate was 96.8% with 1 moderate and 2 large residual shunts. There were 8 cases of new onset atrial fibrillation and 2 TIAs. There were no cases of device embolization or erosion. CONCLUSION: The IrisFIT occluder is a new PFO closure device with several advantages compared to other devices. In this small study cohort, technical success rate, closure rate and adverse event rate were comparable to other devices. The rate of new onset atrial fibrillation was higher in comparison to other studies and warrants further investigation.

Short- and Long-Term Outcomes in Patients With New-Onset Persistent Left Bundle Branch Block After Transcatheter Aortic Valve Replacement.

BACKGROUND: The impact of new-onset persistent left bundle branch block (LBBB) after transcatheter aortic valve replacement (TAVR) on all-cause mortality has been controversial. METHODS: We conducted a systematic review and meta-analysis of eleven studies (7398 patients) comparing the short- and long- outcomes in patients who had new-onset LBBB after TAVR vs. those who did not. RESULTS: During a mean follow-up of 20.5±14months, patients who had new-onset persistent LBBB after TAVR had a higher incidence of all-cause mortality (29.7% vs. 23.6%; OR 1.28 (1.04-1.58), p=0.02), rehospitalization for heart failure (HF) (19.5% vs. 17.3%; OR 1.4 (1.13-1.73), p=0.002), and permanent pacemaker implantation (PPMi) (19.7% vs. 7.1%; OR 2.4 (1.64-3.52), p<0.001) compared with those who did not. Five studies (4180 patients) reported adjusted hazard ratios (HR) for all-cause mortality; new LBBB remained associated with a higher risk of mortality (adjusted HR 1.43 (1.08-1.9), p<0.01, I2=81%). CONCLUSION: Post-TAVR persistent LBBB is associated with higher PPMi, HF hospitalizations, and all-cause mortality. While efforts to identify patients who need post-procedural PPMi are warranted, more studies are required to evaluate the best follow-up and treatment strategies, including the type of pacing device if required, to improve long-term outcomes in these patients.

Permanent Pacemaker Lead Insertion Connected to an External Pacemaker Generator for Temporary Pacing After Transcatheter Aortic Valve Implantation.

BACKGROUND: Outcomes after transcatheter aortic valve implantation (TAVI) have been demonstrated to be at least equivalent in the short term compared to surgical valve implantation (SAVI). However, Conduction abnormalities are more common after TAVI than SAVI and the need for permanent pacemaker implantation is more common after TAVI with the currently commercially available self-expanding valves than after SAVI. Temporary pacemaker implantation may be associated with inability to ambulate, lead migration or perforation and infection. Depending on the monitoring system, some arrhythmias may not be detected. We examined the feasibility and safety of permanent pacemaker lead implantation connected to an external generator in patients undergoing TAVI at our institution. METHODS: This is a retrospective analysis of consecutive patients (between April 1st 2014 and April 30th 2016) at a single center without permanent pacemaker at the time of TAVI who underwent implantation of a permanent pacemaker lead after TAVI connected to an external generator. Focus was the examination of feasibility and safety of our aforementioned approach. In addition, data analysis was performed separating patients into two groups depending on whether (group 1) or not (group 2) permanent pacemaker implantation was ultimately needed. RESULTS: Per our institutional protocol, all consecutive 114 patients underwent insertion of a permanent pacemaker lead after TAVI connected to an external generator. There was one pericardial effusion on postoperative day one that may have been related to the left ventricular wire for TAVI valve delivery. However, perforation due to the pacemaker lead cannot be excluded. Specifically, no access site complications, lead dislodgments or infections occurred. All patients were able to ambulate after the procedure without delay. The permanent pacemaker lead remained in place on average for 4.3 days in group 1 (n = 10) and 4.4 days in group 2 (n = 104) (variance of 3.8 and 3.4 days respectively, [minimum/maximum 0/11 days and 1 and 12 days]). Of the ten patients (9%) who required permanent pacemaker implantation, 8 had a complete atrioventricular block and two had tachy-brady arrhythmias in the context of atrial fibrillation. None of the baseline characteristics including baseline conduction abnormalities were predictors for PPI. CONCLUSION: Implantation of a permanent pacemaker lead connected to an external generator is feasible and safe and could be a better option than implantation of a temporary lead connected to an external generator. It may allow earlier ambulation and facilitate monitoring.