Outcomes with Orbital and Rotational Atherectomy for Inpatient Percutaneous Coronary Intervention

INTRODUCTION: Our objective was to describe the contemporary outcomes of orbital atherectomy (OA) vs. rotational atherectomy (RA) use for inpatient percutaneous coronary intervention (PCI) in the United States. Data on the use of OA vs. RA in contemporary inpatient PCI are limited. METHODS: We queried the Nationwide Readmission Database (NRD) from January to November for the years 2016-2017 to identify hospitalizations of patients who underwent PCI with atherectomy. We conducted a multivariate regression analysis to identify variables associated with in-hospital mortality. RESULTS: We included 77,040 records of patients who underwent inpatient PCI with atherectomy. Of those, 71,610 (93%) had RA, and 5430 (7%) had OA. There was no significant change in the trend of using OA or RA over 2016 and 2017. OA was less utilized in patients presenting with ST-segment elevation myocardial infarction (STEMI) (4.3% vs. 46.8%, p \u3c 0.001). In our cohort, OA was associated with lower in-hospital mortality (3.1% vs. 5%, p \u3c 0.001) and 30-day urgent readmission (\u3c 0.01% vs. 0.2%, p = 0.009), but a higher risk of coronary perforation (1.7% vs. 0.6%, p \u3c 0.001) and cardiac tamponade (1% vs. 0.3%, p \u3c 0.001) and a higher cost of index hospitalization ($28,199 vs.$23,188, p \u3c 0.001) compared with RA. CONCLUSION: RA remains the predominant atherectomy modality for inpatient PCI in the United States (93%). There was no change in the trend of use for either modality over the years 2016 and 2017. OA was noted to have a lower incidence of in-hospital death, but a higher risk of coronary perforation and a higher cost of index hospitalization for the overall unmatched cohorts

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

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

Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.

BACKGROUND: Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk. METHODS: We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population. RESULTS: At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan-Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, -6.6 percentage points; 95% confidence interval [CI], -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P = 0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P = 0.02) and in lower rates of death or stroke (P = 0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation. CONCLUSIONS: Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.)

Challenges in coronary CTO intervention after TAVR: A case report and discussion

Progression of coronary arteries after transcatheter aortic valve replacement is an important issue. Coronary revascularization in these patients can be challenging because of potential hindrance posed by the artificial valve structure in getting access to the coronary ostium. This gets even more difficult in chronic total occlusions (CTOs) that represent the most complex subset of coronary lesions. We report the first case of coronary CTO revascularization in a patient who underwent TAVR a few months prior and discuss the complexities involved in intervening such lesions

White paper on mitigating risk factors for acute kidney injury in TAVR: A protocol to decrease TAVR-associated AKI

Acute kidney injury (AKI) after transcatheter aortic valve replacement (TAVR) portends a poor prognosis. In the TVT registry, AKI after TAVR occurred in 10% of the patients. The etiology of AKI after TAVR is multifactorial but contrast volume remains one of the few modifiable risk factors. As patients referred for TAVR have multiple touch points within a siloed healthcare system, there remains an unmet clinical need of a well-defined clinical pathway to minimize the risk of AKI from the time of referral for TAVR to the completion of the procedure. This white paper aims to provide such a clinical pathway

Volume-outcome relationships for transcatheter aortic valve replacement-risk-adjusted and volume stratified analysis of TAVR outcomes

Objectives: This purpose of the study was to evaluate TAVR outcomes at low, intermediate and high volume institutions. Background: For the care of complex patients, volume-outcome effect is well described. The initial US TAVR experience was limited to a few centers of excellence. The impact of institutional volume on outcomes after TAVR has not been systematically studied. Methods: Within the Banner Health system, TAVR is performed at 3 institutions-a low volume, an intermediate volume and a high volume institution. 181 consecutive patients undergoing TAVR within these 3 institutions were the study cohort. To adjust for bias and confounders between the 3 groups, risk-adjusted multivariate logistic regression and propensity score analysis was performed. The primary endpoint was a composite of mortality, dialysis-dependent renal failure, cerebrovascular accident, need for new permanent pacemaker and readmission within 30 days. Results: The primary endpoint was reached in 38.8% of patients at the high volume institution and 76.2% of patients at the low volume institution (p 30, diabetes, hypertension, prior CAD, CKD and NYHA class III/IV heart failure. Conclusions: High-risk patients undergoing TAVR at a large volume institution have better 30-day outcomes compared to outcomes at intermediate and low volume centers

Percutaneous mitral valve repair: A new treatment for mitral regurgitation

Mitral valve disease affects more than 4 million people in the United States. The gold standard of treatment in these patients is surgical repair or replacement of the valve with a prosthesis. The MitraClip (Abbott Vascular, Menlo Park, CA) is a new technology, which offers an alternative to open surgical repair or replacement via a minimally invasive route. We present an evidence-based clinical update that provides an overview of this technology as it relates to managing patients with significant mitral regurgitation. This review article is particularly useful to noninterventional cardiologists and interventional cardiologists who will be managing patients with this novel technology in increased volumes over the next decade but who do not perform this procedure

“Putting it all together”: Highlighting the global approach to chronic total occlusion revascularization

Preprocedural planning and advanced imaging is vital to achieve a consistent and high level of success for complex coronary chronic total occlusion (CTO) revascularization. Various practice patterns exist around the world when performing coronary artery CTO revascularization. This case report highlights a fusion of global practices in CTO intervention and integration of advanced imaging to achieve successful revascularization