Concomitant Left Atrial Appendage Occlusion and Transcatheter Aortic Valve Replacement Among Patients With Atrial Fibrillation.

BACKGROUND: Atrial fibrillation (AF) is common in patients undergoing transcatheter aortic valve replacement (TAVR) and is associated with increased risk of bleeding and stroke. While left atrial appendage occlusion (LAAO) is approved as an alternative to anticoagulants for stroke prevention in patients with AF, placement of these devices in patients with severe aortic stenosis, or when performed at the same time as TAVR, has not been extensively studied. METHODS: WATCH-TAVR (WATCHMAN for Patients with AF Undergoing TAVR) was a multicenter, randomized trial evaluating the safety and effectiveness of concomitant TAVR and LAAO with WATCHMAN in AF patients. Patients were randomized 1:1 to TAVR + LAAO or TAVR + medical therapy. WATCHMAN patients received anticoagulation for 45 days followed by dual antiplatelet therapy until 6 months. Anticoagulation was per treating physician preference for patients randomized to TAVR + medical therapy. The primary noninferiority end point was all-cause mortality, stroke, and major bleeding at 2 years between the 2 strategies. RESULTS: The study enrolled 349 patients (177 TAVR + LAAO and 172 TAVR + medical therapy) between December 2017 and November 2020 at 34 US centers. The mean age of patients was 81 years, and the mean scores for CHA2DS2-VASc and HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly) were 4.9 and 3.0, respectively. At baseline, 85.4% of patients were taking anticoagulants and 71.3% patients were on antiplatelet therapy. The cohorts were well-balanced for baseline characteristics. The incremental LAAO procedure time was 38 minutes, and the median contrast volume used for combined procedures was 119 mL versus 70 mL with TAVR alone. At the 24-month follow-up, 82.5% compared with 50.8% of patients were on any antiplatelet therapy, and 13.9% compared with 66.7% of patients were on any anticoagulation therapy in TAVR + LAAO compared with TAVR + medical therapy group, respectively. For the composite primary end point, TAVR + LAAO was noninferior to TAVR + medical therapy (22.7 versus 27.3 events per 100 patient-years for TAVR + LAAO and TAVR + medical therapy, respectively; hazard ratio, 0.86 [95% CI, 0.60-1.22]; Pnoninferiority<0.001). CONCLUSIONS: Concomitant WATCHMAN LAAO and TAVR is noninferior to TAVR with medical therapy in severe aortic stenosis patients with AF. The increased complexity and risks of the combined procedure should be considered when concomitant LAAO is viewed as an alternative to medical therapy for patients with AF undergoing TAVR. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03173534.

A novel mechanical mitral valve replacement using Sapien XT.

PATIENT PRESENTATION: We report the case of a 66 year old female who presented to our institution fourteen years after receiving a St. Jude Mechanical Mitral Valve Replacement. She presented in refractory NYHA class IV congestive heart failure with comorbidities of acute renal failure, liver failure, and mental status changes. She was found to have immobility of one of the mitral valve disks with resultant severe mitral stenosis with a mean pressure gradient of 12 mmHg. EVALUATION AND MANAGEMENT: The patient was found to have an STS predicted mortality of 39% with redo surgical MVR, and evaluation by the valve team led to a recommendation of a hybrid surgical and transcatheter procedure. The patient underwent femoral bypass and hypothermia with a sternotomy and left atrial approach. The mechanical discs were removed utilizing needle drivers without removal of the St. Jude ring. Subsequently, a 26 mm Edwards Sapien XT valve was deployed under direct and fluoroscopic visualization. The patient had an event free post-operative course, and one year following the procedure has had an outstanding clinical response with NYHA class II congestive heart failure. Her echocardiogram reveals normal valve function with a MPG of 4 mmHg without mitral regurgitation. CONCLUSION: Transatrial hybrid TMVR within the ring of a St. Jude mechanical mitral valve appears to be a feasible procedure which may be used in the future to decrease morbidity and mortality associated with high-risk redo-MVR in patients with mechanical mitral valve prostheses.

Transcatheter Aortic Valve Replacement in Patients With Systolic Heart Failure and Moderate Aortic Stenosis: TAVR UNLOAD.

BACKGROUND: Neurohormonal modulation and afterload reduction are key for treatment of heart failure with reduced ejection fraction (HFrEF). In HFrEF patients with concomitant moderate aortic stenosis (AS), treatment with transcatheter aortic valve replacement (TAVR) may be complementary to guideline-directed medical therapy (GDMT). OBJECTIVES: This study sought to determine whether TAVR for moderate AS provides clinical benefit in patients with HFrEF on top of GDMT. METHODS: We performed an investigator-initiated, international, randomized controlled trial in patients with HFrEF on GDMT with moderate AS who were suitable for transfemoral TAVR with a balloon-expandable valve. Patients were randomized 1:1 to TAVR or clinical aortic stenosis surveillance (CASS) with aortic valve replacement upon progression to severe AS. The primary endpoint was the hierarchical occurrence of: 1) all-cause death; 2) disabling stroke; 3) disease-related hospitalizations and heart failure equivalents; and 4) change from baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score analyzed using the win ratio. RESULTS: From January 2017 to December 2022, 178 patients were randomized to TAVR (n = 89) or AS surveillance (n = 89). The mean age was 77 years, 20.8% were female, and 55.6% were in NYHA functional class III or IV. The median follow-up duration was 23 months (Q1-Q3: 12-33 months). A total of 38 (43%) patients in the CASS group (of whom 35 had progressed to severe AS) underwent TAVR at a median of 12 months postrandomization. TAVR was associated with wins in 47.6% of pairs, compared with 36.6% in the CASS group, resulting in a win ratio of 1.31 (95% CI: 0.91-1.88; P = 0.14). At 1 year, TAVR resulted in a greater improvement in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score compared with the CASS group (12.8 ± 21.9 points vs 3.2 ± 22.8 points; P = 0.018). CONCLUSIONS: TAVR was not superior to AS surveillance for the primary hierarchical composite endpoint in patients with moderate AS and HFrEF on GDMT. Preemptive TAVR for moderate AS was safe and may provide clinically meaningful quality-of-life benefits.

Comparison of role of early (less than six hours) to later (more than six hours) or no cardiac catheterization after resuscitation from out-of-hospital cardiac arrest.

Despite reports of patients with resuscitated sudden cardiac arrest (rSCA) receiving acute cardiac catheterization, the efficacy of this strategy is largely unknown. We hypothesized that acute cardiac catheterization of patients with rSCA would improve survival to hospital discharge. A retrospective cohort of 240 patients with out-of-hospital rSCA caused by ventricular tachycardia or fibrillation was identified from 11 institutions in Seattle, Washington from 1999 through 2002. Patients were grouped into those receiving acute catheterization within 6 hours (≤6-hour group, n = 61) and those with deferred catheterization at >6 hours or no catheterization during the index hospitalization (>6-hour group, n = 179). Attention was directed to survival to hospital discharge, neurologic status, extent of coronary artery disease, presenting electrocardiographic findings, and symptoms before arrest. Propensity-score methods were used to adjust for the likelihood of receiving acute catheterization. Survival was greater in patients who underwent acute catheterization (72% in the ≤6-hour group vs 49% in the >6-hour group, p = 0.001). Percutaneous coronary intervention was performed in 38 of 61 patients (62%) in the ≤6-hour group and 13 of 170 patients (7%) in the >6-hour group (p <0.0001). Neurologic status was similar in the 2 groups. A significantly larger percentage of patients in the acute catheterization group had symptoms before cardiac arrest and had ST-segment elevation on electrocardiogram after resuscitation. Age, bystander cardiopulmonary resuscitation, daytime presentation, history of percutaneous coronary intervention or stroke, and acute ST-segment elevation were positively associated with receiving cardiac catheterization. In conclusion, in this series of patients who sustained out-of-hospital cardiac arrest, acute catheterization (<6 hours of presentation) was associated with improved survival.

Percutaneous right ventricular assist device as support for cardiogenic shock due to right ventricular infarction.

Right ventricular myocardial infarction can lead to cardiogenic shock and death. We report on a patient with a right coronary artery infarction and right ventricular cardiogenic shock with only minimal left ventricular involvement who, after failing usual therapies, underwent insertion of a TandemHeart (Cardiac Assist, Inc., Pittsburgh, Pennsylvania) peripheral right ventricular assist device. The device was used for 48 hours to allow for recovery of right ventricular function and was then removed. The patient was discharged on hospital day 17 and was doing well at 6-month follow up.