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.

Management of STEMI during the COVID-19 pandemic: Lessons learned in 2020 to prepare for 2021.

As the prevalence of asymptomatic COVID-19 continues to increase, there is an increasing possibility that patients with COVID-19 may presen with ST-segment elevation myocardial infarction (STEMI). With social distancing and restricted access to preventive healthcare and emergency services, the management of acute cardiac emergencies such as myocardial infarction has suffered collateral damage. Thus far, global trends suggest a decrease in STEMI activations with possible worse outcomes due to delayed presentation and management. In this review, we discuss the challenges to STEMI management in the COVID-19 era and provide potential solutions for adherence to evidence-based therapies as the pandemic progresses into the year 2021.

Stenting in unprotected left main coronary stenosis-"What no progress"?

There does not appear to be a difference in patient outcomes of percutaneous coronary intervention for unprotected left main coronary artery stenosis whether using first- or second-generation drug elutting stent. This is despite increase in patients having more adjunctive procedures such as intravascular imaging and newer generation antiplatelet agents. This single-center study provokes questions as to why there has not been improvement in outcomes.

Thirty-Day Outcomes of Transcatheter Mitral Valve Replacement for Degenerated Mitral Bioprostheses (Valve-in-Valve), Failed Surgical Rings (Valve-in-Ring), and Native Valve With Severe Mitral Annular Calcification (Valve-in-Mitral Annular Calcification) in the United States: Data From the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry.

BACKGROUND: Transcatheter mitral valve replacement using aortic transcatheter heart valves has recently become an alternative for patients with degenerated mitral bioprostheses, failed surgical repairs with annuloplasty rings or severe mitral annular calcification who are poor surgical candidates. Outcomes of these procedures are collected in the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry. A comprehensive analysis of mitral valve-in-valve (MViV), mitral valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) outcomes has not been performed. We sought to evaluate short-term outcomes of early experience with MViV, MViR, and ViMAC in the United States. METHODS: Retrospective analysis of data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. RESULTS: Nine hundred three high-risk patients (median Society of Thoracic Surgeons score 10%) underwent MViV (n=680), MViR (n=123), or ViMAC (n=100) between March 2013 and June 2017 at 172 hospitals. Median age was 75 years, 59.2% female. Technical and procedural success were higher in MViV. Left ventricular outflow tract obstruction occurred more frequently with ViMAC (ViMAC=10%, MViR=4.9%, MViV=0.7%; P<0.001). In-hospital mortality (MViV=6.3%, MViR=9%, ViMAC=18%; P=0.004) and 30-day mortality (MViV=8.1%, MViR=11.5%, ViMAC=21.8%; P=0.003) were higher in ViMAC. At 30-day follow-up, median mean mitral valve gradient was 7 mm Hg, most patients (96.7%) had mitral regurgitation grade ≤1 (+) and were in New York Heart Association class I to II (81.7%). CONCLUSIONS: MViV using aortic balloon-expandable transcatheter heart valves is associated with a low complication rate, a 30-day mortality lower than predicted by the Society of Thoracic Surgeons score, and superior short-term outcomes than MViR and ViMAC. At 30 days, patients in all groups experienced improvement of symptoms, and valve performance remained stable. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02245763.

Mechanical thrombectomy revisited is there any value?

The use of mechanical thrombectomy in STEMI with large amount of jeopardized myocardium may preserve regional wall motion When appropriate and done with proper removal technique, there does not appear to be any increased incidence of neurologic complications The guideline recommendation that mechanical thrombectomy should not be done routinely is supported by these authors.

Learning curves for TAVR: Not quite see one, do one teach one.

The learning curve for TAVR is determined based on technical (procedural) data from PARTNER-1 Trial The number of cases needed to reach a learning curve for TAVR in PARTNER-1 was 50 for original sites and fell to 25 for late entering sites Analyses such as this is important in developing guidelines for other emerging technologies.

To aspirate or not!: The question may be not if, but when.

Current guidelines indicate that routine aspiration thrombectomy (AT) has a level III indication and AT is only indicated for "bail-out" indications. "Bail-out" situations are not well defined. The AT catheter may still be necessary and have other uses such as distal contrast or drug delivery.