Prospective Study of TMVR Using Balloon-Expandable Aortic Transcatheter Valves in MAC: MITRAL Trial 1-Year Outcomes.

OBJECTIVES: The aim of this study was to evaluate 1-year outcomes of valve-in-mitral annular calcification (ViMAC) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. BACKGROUND: The MITRAL trial is the first prospective study evaluating the feasibility of ViMAC using balloon-expandable aortic transcatheter heart valves. METHODS: A multicenter prospective study was conducted, enrolling high-risk surgical patients with severe mitral annular calcification and symptomatic severe mitral valve dysfunction at 13 U.S. sites. RESULTS: Between February 2015 and December 2017, 31 patients were enrolled (median age 74.5 years [interquartile range (IQR): 71.3 to 81.0 years], 71% women, median Society of Thoracic Surgeons score 6.3% [IQR: 5.0% to 8.8%], 87.1% in New York Heart Association functional class III or IV). Access was transatrial (48.4%), transseptal (48.4%), or transapical (3.2%). Technical success was 74.2%. Left ventricular outflow tract obstruction (LVOTO) with hemodynamic compromise occurred in 3 patients (transatrial, n = 1; transseptal, n = 1; transapical, n = 1). After LVOTO occurred in the first 2 patients, pre-emptive alcohol septal ablation was implemented to decrease risk in high-risk patients. No intraprocedural deaths or conversions to open heart surgery occurred during the index procedures. All-cause mortality at 30 days was 16.7% (transatrial, 21.4%; transseptal, 6.7%; transapical, 100% [n = 1]; p = 0.33) and at 1 year was 34.5% (transatrial, 38.5%; transseptal, 26.7%; p = 0.69). At 1-year follow-up, 83.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.1 mm Hg (IQR: 5.6 to 7.1 mm Hg), and all patients had ≤1+ mitral regurgitation. CONCLUSIONS: At 1 year, ViMAC was associated with symptom improvement and stable transcatheter heart valve performance. Pre-emptive alcohol septal ablation may prevent transcatheter mitral valve replacement-induced LVOTO in patients at risk. Thirty-day mortality of patients treated via transseptal access was lower than predicted by the Society of Thoracic Surgeons score. Further studies are needed to evaluate safety and efficacy of ViMAC.

Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes.

OBJECTIVES: The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. BACKGROUND: The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses. METHODS: High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year). RESULTS: Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+. CONCLUSIONS: Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year.

Prospective Evaluation of TMVR for Failed Surgical Annuloplasty Rings: MITRAL Trial Valve-in-Ring Arm 1-Year Outcomes.

OBJECTIVES: The authors report 1-year outcomes of high-risk patients with failed surgical annuloplasty rings undergoing transseptal mitral valve-in-ring (MViR) with the SAPIEN 3 aortic transcatheter heart valve (THV). BACKGROUND: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective study evaluating transseptal MViR with the SAPIEN 3 aortic THV in high-risk patients with failed surgical annuloplasty rings. METHODS: Prospective enrollment of high-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis and failed annuloplasty rings at 13 U.S. sites. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year). RESULTS: Thirty patients were enrolled between January 2016 and October 2017 (median age 71.5 years [interquartile range: 67.0 to 76.8 years], 36.7% women, median Society of Thoracic Surgeons score 7.6% [interquartile range: 5.1% to 11.8%], 76.7% in New York Heart Association functional class III or IV). Technical success was 66.7% (driven primarily by need for a second valve in 6 patients). There was no intraprocedural mortality or conversion to surgery. The primary performance endpoint was achieved in 85.7% of survivors at 30 days (24 of 28) and 89.5% of patients alive at 1 year with echocardiographic data available (17 of 19). All-cause mortality at 30 days was 6.7% and at 1 year was 23.3%. Among survivors at 1-year follow-up, 84.2% were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.0 mm Hg (interquartile range: 4.7 to 7.3 mm Hg), and all had ≤1+ MR. CONCLUSIONS: Transseptal MViR was associated with a 30-day mortality rate lower than predicted by the Society of Thoracic Surgeons score. At 1 year, transseptal MViR was associated with symptom improvement and stable THV performance.

Hybrid approach to postmyocardial infarction ventricular septal defect repair.

Postinfarction ventricular septal rupture is a rare and devastating complication of myocardial infarction. Despite attempts at acute surgical and percutaneous defect closure, morbidity and mortality remain high. Herein, we describe a hybrid surgical and catheter-based approach to defect closure in a 63-year-old woman with postinfarction ventricular septal rupture and cardiogenic shock.

Open atrial transcatheter mitral valve replacement in patients with mitral annular calcification.

BACKGROUND: Mitral valve replacement in the setting of severe mitral annular calcification remains a surgical challenge. Transcatheter mitral valve replacement (TMVR) using an aortic balloon-expandable transcatheter heart valve is emerging as a potential treatment option for high surgical risk patients. Transseptal, transapical, or transatrial access is not always feasible, so an understanding of alternative implantation techniques is important. OBJECTIVES: The authors sought to present a step-by-step description of a contemporary transatrial TMVR technique using balloon-expandable aortic transcatheter heart valves. This procedure has evolved over time to address valve migration, left ventricular outflow tract obstruction, and paravalvular leak. The authors present a refined technique that has been associated with the most reproducible outcomes. METHODS: A step-by-step description of the TMVR technique and outcomes of 8 patients treated using this technique are described. Baseline patient clinical and echocardiographic characteristics and 30-day post-TMVR outcomes are presented. RESULTS: Eight patients underwent transatrial TMVR at a single institution. Five had previous cardiac surgery. Mean STS score was 8%. Technical success by MVARC (Mitral Valve Academic Research Consortium) criteria was 100%. There was zero in-hospital and 30-day mortality. Procedural success by MVARC criteria at 30 days was 100%. Paravalvular leak immediately post-implant was none or trace in 6 and mild in 1. CONCLUSIONS: The technique described is reproducible and was associated with favorable outcomes in this early experience. It represents a useful technique for the treatment of mitral valve disease in the setting of severe annular calcification. A structured and defined implantation technique is critical to investigators as this field evolves.

Open Atrial Transcatheter Mitral Valve Replacement in Patients With Mitral Annular Calcification.

BACKGROUND: Mitral valve replacement in the setting of severe mitral annular calcification remains a surgical challenge. Transcatheter mitral valve replacement (TMVR) using an aortic balloon-expandable transcatheter heart valve is emerging as a potential treatment option for high surgical risk patients. Transseptal, transapical, or transatrial access is not always feasible, so an understanding of alternative implantation techniques is important. OBJECTIVES: The authors sought to present a step-by-step description of a contemporary transatrial TMVR technique using balloon-expandable aortic transcatheter heart valves. This procedure has evolved over time to address valve migration, left ventricular outflow tract obstruction, and paravalvular leak. The authors present a refined technique that has been associated with the most reproducible outcomes. METHODS: A step-by-step description of the TMVR technique and outcomes of 8 patients treated using this technique are described. Baseline patient clinical and echocardiographic characteristics and 30-day post-TMVR outcomes are presented. RESULTS: Eight patients underwent transatrial TMVR at a single institution. Five had previous cardiac surgery. Mean STS score was 8%. Technical success by MVARC (Mitral Valve Academic Research Consortium) criteria was 100%. There was zero in-hospital and 30-day mortality. Procedural success by MVARC criteria at 30 days was 100%. Paravalvular leak immediately post-implant was none or trace in 6 and mild in 1. CONCLUSIONS: The technique described is reproducible and was associated with favorable outcomes in this early experience. It represents a useful technique for the treatment of mitral valve disease in the setting of severe annular calcification. A structured and defined implantation technique is critical to investigators as this field evolves.

Aorta-innominate bypass through ministernotomy.

Atherosclerotic innominate artery occlusive disease can lead to cerebral and upper extremity ischemia. Innominate artery angioplasty and stenting can be complicated by stent fractures and restenosis; furthermore, this technique is limited in treatment of innominate artery occlusions. Ministernotomy to the second or third intercostal space can be used instead of conventional full sternotomy for open surgical revascularization of the innominate artery with excellent perioperative and long-term outcomes. This series of three consecutive patients highlights the technique of aorta-innominate artery bypass through ministernotomy.

Paravalvular regurgitation after conventional aortic and mitral valve replacement: A benchmark for alternative approaches.

OBJECTIVE: Paravalvular regurgitation is a known complication after transcatheter and sutureless aortic valve replacement. Paravalvular regurgitation also may develop in patients undergoing percutaneous mitral valve replacement. There are few studies on contemporary surgical valve replacement for comparison. We sought to determine the contemporary occurrence of paravalvular regurgitation after conventional surgical valve replacement. METHODS: We performed a single-center retrospective database review involving 1774 patients who underwent valve replacement surgery from April 2004 to December 2012: aortic in 1244, mitral in 386, and combined aortic and mitral in 144. Follow-up echocardiography was performed in 73% of patients. Patients with endocarditis were analyzed separately from noninfectious paravalvular leaks. Statistical comparisons were performed to determine differences in paravalvular regurgitation incidence and survival. RESULTS: During follow-up, 1+ or greater (mild or more) paravalvular regurgitation occurred in 2.2% of aortic cases and 2.9% of mitral cases. There was 2+ or greater (moderate or more) paravalvular regurgitation in 0.9% of aortic and 2.2% of mitral cases (P = .10). After excluding endocarditis, late noninfectious regurgitation 2+ or greater was detected in 0.5% of aortic and 0.4% of mitral cases (P = .93); there were no reoperations or percutaneous closures for noninfectious paravalvular regurgitation. CONCLUSIONS: In an academic medical center, the overall rate of paravalvular regurgitation is low, and late clinically significant noninfectious paravalvular regurgitation is rare. The benchmark for paravalvular regurgitation after conventional valve replacement is high and should be considered when evaluating patients for transcatheter or sutureless valve replacement.

Modified TandemHeart ventricular assist device for infant and pediatric circulatory support.

PURPOSE: The development of pediatric ventricular assist device (VAD) circuits with lower flow ranges for infants and small children is ongoing. We present our results with modifying a readily available adult VAD to support the pediatric population. DESCRIPTION: The TandemHeart VAD (CardiacAssist, Pittsburgh, PA) circuit was modified to include a variable restrictive recirculation shunt to permit lower flow ranges in small pediatric patients. EVALUATION: Initial benchtop flow rates and pressures were studied. Hemolysis trials were performed using whole bovine blood to compare plasma-free hemoglobin levels between modified and unmodified VAD circuits. The modified VAD was surgically implanted in 7 piglets (6 to 14 kg) and which supported them for 4 hours. Levels of hemolysis did not increase and full hemodynamic support was achieved. The modified TandemHeart VAD with a recirculation shunt was subsequently implanted in 2 pediatric patients who were bridged to transplant successfully. CONCLUSIONS: Because of its simplicity, availability, low prime volume, greater patient flow range, and lower cost, the modified TandemHeart VAD with a recirculation shunt should be considered as an alternative to extracorporeal membrane oxygenation and other pulsatile VADs in children.

Reoperation after vascular ring repair.

The majority of patients having surgical intervention for a vascular ring have resolution of their symptoms. However, 5% to 10% of these patients develop recurrent symptoms related either to airway or esophageal compression and may require reoperation. In our series of 300 patients with vascular rings, we performed a reoperation on 26 patients, not all of whom were originally operated on at our institution. The four primary indications for reoperation were Kommerell diverticulum (n = 18), circumflex aorta (n = 2), residual scarring (n = 2), and tracheobronchomalacia requiring aortopexy (n = 4). All patients undergoing reoperation have had preoperative evaluation with bronchoscopy and computed tomographic scanning (CT) with 3-dimensional reconstruction. Patients with dysphagia have had a barium esophagram and esophagoscopy. Patients with a Kommerell diverticulum have undergone resection of the diverticulum and transfer of the left subclavian artery to the left carotid artery. The aortic uncrossing procedure has been used in patients with a circumflex aorta. Aortopexy has been used to treat anterior compression of the trachea by the aorta. Results of these reinterventions have been successful in nearly all cases. Lessons learned from these reoperations can be applied to prevent the need for reoperation by properly selecting the correct initial operation. A dedicated team caring for these children consisting of medical imaging, otolaryngology, cardiovascular-thoracic surgery, and critical care is imperative.