Early Outcomes of Percutaneous Transvenous Transseptal Transcatheter Valve Implantation in Failed Bioprosthetic Mitral Valves, Ring Annuloplasty, and Severe Mitral Annular Calcification.

OBJECTIVES: The aim of this study was to examine 1-year outcomes of transseptal balloon-expandable transcatheter heart valve implantation in failed mitral bioprosthesis, ring annuloplasty, and mitral annular calcification (MAC). BACKGROUND: Immediate outcomes following transseptal mitral valve implantation in failed bioprostheses are favorable, but data on subsequent outcomes are lacking. METHODS: Percutaneous transseptal implantation of balloon-expandable transcatheter heart valves was performed in 87 patients with degenerated mitral bioprostheses (valve in valve [VIV]) (n = 60), previous ring annuloplasty (valve in ring) (n = 15), and severe MAC (valve in MAC) (n = 12). RESULTS: The mean Society of Thoracic Surgeons risk score was 13 ± 8%, and the mean age was 75 ± 11 years. Acute procedural success was achieved in 78 of 87 patients (90%) in the overall group and 58 of 60 (97%) in the VIV group, with a success rate of 20 of 27 (74%) in the valve in ring/valve in MAC group. Thirty-day survival free of death and cardiovascular surgery was 95% (95% confidence interval [CI]: 92% to 97%) in the VIV subgroup and 78% (95% CI: 70% to 86%) in the valve in ring/valve in MAC group (p = 0.008). One-year survival free of death and cardiovascular surgery was 86% (95% CI: 81% to 91%) in the VIV group compared with 68% (95% CI: 58% to 78%) (p = 0.008). At 1 year, 36 of 40 patients (90%) had New York Heart Association functional class I or II symptoms, no patients had more than mild residual mitral prosthetic or periprosthetic regurgitation, and the mean transvalvular gradient was 7 ± 3 mm Hg. CONCLUSIONS: One-year outcomes following successful transseptal balloon-expandable transcatheter heart valve implantation in high-risk patients with degenerated mitral bioprostheses are excellent, characterized by durable symptom relief and prosthesis function. Although mitral valve in ring and valve in MAC have higher operative morbidity and mortality, 1-year outcomes after an initially successful procedure are favorable in carefully selected patients.

Descending septal branch of right coronary artery: Rare, but important in hypertrophic cardiomyopathy.

A 54year old man with hypertrophic cardiomyopathy was evaluated for alcohol septal ablation. However there were no sizeable septal branches from the left anterior descending artery supplying the basal septum. He was found to have a rare variant, the descending septal branch from ostial right coronary artery and underwent ablation through the same. We describe our case and the relevant literature available for use of this anatomical variant in alcohol septal ablation.

Large-field intravascular ultrasound for annular sizing and predicting paravalvular regurgitation during TAVR: comparisons with multidetector computed tomography and transoesophageal echocardiography.

AIMS: The use of contrast media with multidetector computed tomography (MDCT) may induce acute kidney injury in patients with renal failure undergoing transcatheter aortic valve replacement (TAVR). We investigated the role of large-field intravascular ultrasound (IVUS) vs. MDCT and two-dimensional transoesophageal echocardiography (2D-TEE) for annular sizing and predicting paravalvular regurgitation (PVR) during TAVR. METHODS AND RESULTS: The aortic annulus was measured by large-field IVUS and 2D-TEE, and compared with MDCT in 50 patients undergoing TAVR. The IVUS and MDCT annular areas and diameters were not significantly different (446 ± 87 mm2 and 23.8 ± 84 mm vs. 466 ± 84 mm2 and 24 ± 2.1 mm, respectively; P > 0.05). IVUS and MDCT mean annular diameters were significantly greater than TEE diameter (23.8 ± 2.4 and 24 ± 2.1 vs. 22 ± 0.65 mm, respectively; P < 0.01). PVR ≥ Mild occurred in 13 patients (26%); 5 patients required post-dilation and 2 patients a second valve. Receiver operating characteristic analyses showed that transcatheter heart valve (THV) area - IVUS or MDCT areas equally predicted of ≥ mild PVR (areas under the curve [AUC] 0.79 and 0.81, respectively; P < 0.001), and were greater than THV diameter-TEE diameter (AUC 0.79 and 0.81 vs. 0.56, respectively; P < 0.05). CONCLUSIONS: The aortic annular measurements and predicting PVR by large field IVUS were not significantly different from those of MDCT, but were greater than those of TEE. Large filed IVUS can be reliably used in lieu of MDCT for annular sizing in patients with aortic stenosis and renal failure or suboptimal MDCT images.

Percutaneous Transvenous Transseptal Transcatheter Valve Implantation in Failed Bioprosthetic Mitral Valves, Ring Annuloplasty, and Severe Mitral Annular Calcification.

OBJECTIVES: This study sought to examine the feasibility, safety, and intermediate-term outcomes in patients undergoing percutaneous transvenous transcatheter mitral valve implantation in failed bioprosthesis, ring annuloplasty, and calcific mitral stenosis. BACKGROUND: Surgical mitral valve replacement in patients with previous surgery or severe mitral annular calcification (MAC) is often associated with high or prohibitive risk. METHODS: Percutaneous transfemoral antegrade transseptal implantation of Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, California) was performed in 48 patients with degenerated mitral bioprosthesis (n = 33), previous ring annuloplasty (n = 9), and severe MAC (n = 6). RESULTS: The mean Society of Thoracic Surgeons risk score was 13.2 ± 7.4% with a mean age 76 ± 11 years. Acute procedural success was achieved in 42 of 48 patients (88%) in the overall group and 31 of 33 (94%) in the failed bioprosthetic mitral valve group and success rate of 11 of 15 (73%) in patients with failed annuloplasty rings and MAC. After successful procedure, no patients had > mild residual mitral prosthetic or periprosthetic regurgitation; mean transvalvular gradients were 6 ± 2.5 mm Hg. Thirty-day survival free of death and cardiovascular surgery was 85% in the overall group and 91% in the failed bioprosthetic mitral valve subgroup. CONCLUSIONS: Transfemoral percutaneous transvenous mitral valve implantation in high-risk patients with degenerated bioprosthesis is safe, effective, and associated with rapid improvement in hemodynamics, short length of stays, and improved functional status. Percutaneous mitral valve implantation in patients with failed annuloplasty rings and severe MAC is a promising therapy with significant short-term morbidity and mortality that requires further study.

Impact of Transcatheter Aortic Valve Replacement on Surgical Volumes and Outcomes in a Tertiary Academic Cardiac Surgical Practice.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) was FDA approved for the Sapien valve (Edwards Lifesciences) in the United States in November 2011. We sought to examine the impact of TAVR post-FDA approval on aortic valve surgery at our institution. STUDY DESIGN: Prospective data were collected on 573 consecutive patients that underwent surgical aortic valve replacement (SAVR) or TAVR with either the Sapien or Sapien XT from January 1, 2009 through December 31, 2014. RESULTS: Patients were divided into the following groups: SAVR before TAVR (n = 215), SAVR post TAVR (n = 163), and TAVR (n = 195). The 30-day mortality was not different among the 3 groups, but the mortality for the SAVR post TAVR group was better than the SAVR before TAVR group (p = 0.03). Postoperative hospital length of stay, ventilation hours, and atrial fibrillation were all decreased in the TAVR group. The number of isolated SAVRs increased after TAVR from 60 per year in group 1 to 67 per year in group 2. The total number of all isolated aortic valve procedures (SAVR + TAVR) increased from 60 per year to 177 per year. The TAVR group was divided into the following subgroups to examine the procedural learning curve: patients 1 to 50, patients 51 to 100, and patients 101 to 195. Mortality was higher in group 1 (8%) vs group 2 (0%) and group 3 (1%). CONCLUSIONS: Since initiation of the TAVR program at our institution, the total number of aortic valve procedures has increased. Transcatheter aortic valve replacement patients had more preoperative comorbidities, but no difference in postoperative morbidity or mortality and shorter length of stay. Transcatheter aortic valve replacement mortality has continued to improve since the inception of the program.

Left atrial appendage occlusion for stroke prevention.

Atrial fibrillation (AF) remains the most common arrhythmia encountered in clinical practice. One of its more common deleterious effects is the development of thromboembolism leading to stroke. The left atrial appendage (LAA) has been shown to the site of the majority of thrombus formation leading to stroke. Anticoagulation with warfarin has been the treatment of choice for prevention of embolic events. Newer anticoagulants have been developed but they still have the potential side effect of causing major bleeding. Occlusion of the LAA has emerged as an alternative therapeutic approach to medical therapy. The aim of this article is to discuss in detail the role of the LAA in thromboembolism in AF, role of device and surgical therapies, and the current clinical data supporting their use. This is particularly timely in that there is now an approved LAA closure device approved in the US for stroke prevention in patients with nonvalvular AF.

Usefulness of three-dimensional transesophageal echocardiography in retrieval of a dislodged vascular plug used to close paraprosthetic mitral regurgitation.

In this report, we describe a case of periprocedural dislodgement of an Amplatzer Vascular Plug II device during percutaneous closure of severe paraprosthetic mitral regurgitation. The free plug in the left atrium was successfully retrieved percutaneously using a snare inserted through a sheath under live/real time three-dimensional transesophageal echocardiographic guidance. This proved crucial not only in guiding device deployment but also in detecting and helping management of complications.

Transcatheter aortic valve replacement program in the post-food and drug administration approval era: early outcomes at an academic medical center.

OBJECTIVE: Transcatheter aortic valve replacement (TAVR) has recently become a suitable alternative for treatment of symptomatic aortic stenosis in patients who are at very high risk for morbidity and mortality with conventional corrective surgery. In the fall of 2011, the Food and Drug Administration approved the use of TAVR, allowing for reimbursement at institutions outside of investigative trials. We report the initiation of a TAVR-based program at an academic tertiary care facility that did not participate in the Placement of Aortic Transcatheter Valves (PARTNER) 1 or PARTNER II trials. METHODS: A total of 160 patients were evaluated for TAVR from May 2012 through June 2013. Transcatheter aortic valve replacement was found to be appropriate for 50 (31%). RESULTS: In this experience, morbidity and mortality were similar to those reported for the PARTNER trial (30-day hospital mortality was 8%). A single case of presumed cerebrovascular accident was observed. These results demonstrate that the real-world application can be done with comparable results. Implementation of lessons learned in the trials allowed a very short learning curve and excellent results after only a limited number of patients. Use of computed tomography reconstructed images for operative planning, including fluoroscopic angle, facilitated minimal use of contrast in each case. CONCLUSIONS: Transcatheter aortic valve replacement is a viable option for patients at very high risk for surgical intervention in the post-Food and Drug Administration approval era. Real-world results comparable with published outcomes from experienced centers involved in the PARTNER trial can be achieved.

Incremental value of three-dimensional transesophageal echocardiography over the two-dimensional technique in percutaneous closure of aortic paraprosthetic regurgitation.

We describe 2 patients with significant aortic paraprosthetic regurgitation who underwent percutaneous closure where live/real time three-dimensional transesophageal echocardiography provided incremental value over two-dimensional transesophageal echocardiography.

Live/real time three-dimensional transesophageal echocardiographic assessment of the spinal cord.

We present an adult patient in whom live/real time three-dimensional transesophageal echocardiography (3DTEE) provided incremental value in the assessment of the spinal cord as compared to two-dimensional transesophageal echocardiographic (2DTEE) findings published in the literature. It improved accurate identification and assessment of the anterior radiculomedullary spinal arteries which may have an important clinical application in monitoring for spinal cord ischemia during thoracic aortic surgery. Because the spinal cord and spinal canal could be examined using not only transverse but also coronal (frontal), sagittal, and oblique planes, 3DTEE further allowed for three-dimensional measurements of the dimensions and volumetric analysis of the visualized spinal cord and spinal canal. These may have implications in the assessment of spinal cord edema due to trauma and other conditions which result in increase in the size and volume of the spinal cord.

Incremental value of three-dimensional echocardiography over the two-dimensional technique in the assessment of combined sinus of valsalva rupture into the right ventricle and adjacent perimembranous ventricular septal defect.

We describe the incremental value of live/real time three-dimensional (3D) echocardiography over the 2D technique in the assessment of ruptured right sinus of Valsalva into the right ventricle associated with an adjacent perimembranous ventricular septal defect in an elderly patient.

Utility of live/real time three-dimensional transesophageal echocardiography in the assessment and percutaneous intervention of bioprosthetic pulmonary valve stenosis.

Accurate echocardiographic evaluation of the pulmonary valve is technically difficult because of its close proximity to the left lung, which often limits decision making. Pulmonary valvotomy is the intervention of choice for symptomatic pulmonary valve stenosis, but fluoroscopy lacks appropriate real time anatomic detail. In this report, we present a case where direct imaging of the pulmonary valve with live/real time three-dimensional transesophageal echocardiography (3DTEE) aided in accurate evaluation and was then used to help guide and monitor successful valvuloplasty of a stenotic pulmonary valve bioprosthesis. We demonstrate that even in cases where two-dimensional (2D) evaluation of the pulmonary valve is difficult, the use of live/real time 3DTEE allows for accurate evaluation of bioprosthetic pulmonary valve structure and function, and enhances the precision and monitoring of percutaneous valvuloplasty.

Transvenous, antegrade Melody valve-in-valve implantation for bioprosthetic mitral and tricuspid valve dysfunction: a case series in children and adults.

OBJECTIVES: The purpose of this study was to report the results of percutaneous valve-in-valve therapy using the Melody valve (Medtronic, Minneapolis, Minnesota) for patients with degenerated mitral and tricuspid bioprosthetic valves. BACKGROUND: Open surgery for replacement of degenerated bioprosthetic valves is associated with morbidity and mortality. METHODS: Nineteen patients (median age 65 years, range 10 to 88 years; 7 males) with degenerated mitral (n = 9) or tricuspid (n = 10) bioprosthetic valves underwent transvenous valve-in-valve implantation of the Melody valve. RESULTS: In the mitral patients, the mean Society of Thoracic Surgeons mortality score was 13.3 ± 5.6%. All patients had a prosthetic valve mean diastolic inflow gradient ≥5 mm Hg. Moderate or worse regurgitation was present in 7 of 9 mitral and 7 of 10 tricuspid patients. Implantation of a Melody valve was successful in all. Among the mitral patients, mean diastolic gradient decreased from 12.3 ± 4.6 mm Hg to 5.2 ± 2 mm Hg (p < 0.01). Residual regurgitation was trivial to mild in 6, mild to moderate in 2, and moderate in 1 patient. Among the tricuspid patients, mean diastolic gradient decreased from 10.0 ± 4.3 mm Hg to 5.6 ± 2.5 mm Hg (p < 0.01). Residual regurgitation was trivial to mild in 9 and mild to moderate in 1 patient. New York Heart Association functional class improved in 17 of 19 patients (p < 0.01). No periprocedural deaths, myocardial infarctions, strokes, or valve embolizations occurred. Vascular access site complications occurred in 4 patients. CONCLUSIONS: Percutaneous valve-in-valve implantation of the Melody valve in the mitral or tricuspid position for treatment of bioprosthetic valve dysfunction is feasible and can lead to significant symptomatic improvement in carefully selected high-risk patients.

Five-year follow-up of the Sirolimus-Eluting Stents vs Vascular Brachytherapy for Bare Metal In-Stent Restenosis (SISR) trial.

OBJECTIVES: The aim of this study was to evaluate the 5-year clinical safety and efficacy outcomes of patients treated for in-stent restenosis of bare-metal stents (BMSs). BACKGROUND: The SISR trial is a prospective, randomized trial that compared the safety and efficacy of sirolimus-eluting stent (SES) vs vascular brachytherapy (VBT) for the treatment of BMS in-stent restenosis. METHODS: A total of 384 patients with BMS in-stent restenosis were randomized to treatment with SES (n = 259) or VBT (n = 125) and were followed for 5 years. RESULTS: At 5 years, the rates of target lesion revascularization (TLR) had narrowed and were nonsignificant between the SES and VBT groups, with TLR rates of 24.7% and 31.2% (95% CI -16.3% to 2.8%, P = .179) respectively. Target vessel failure was 33.6% vs 36.8% (95% CI -13.5% to 6.7% P = .568) for SES compared with VBT. The rate of major adverse cardiac event at 5 years was 34.0% vs 36.8% (95% CI -13.1% to7.1%, P = .648) for the SES compared with VBT. There were no differences between SES and VBT in terms of survival free from TLR (72.9% vs 66.4%, log-rank P = .08) or from target vessel failure (64.4% vs 61.3%, log-rank P = .349). There were no significant differences in the rates of definite/probable stent thrombosis (5.9% vs 2.5%, 95% CI -7.9% to 1.3%, P = .182) between the 2 groups. CONCLUSIONS: At a 5-year follow-up, no differences in safety or efficacy outcomes were observed for treatment of BMS restenosis with SES vs VBT. There were no significant differences in survival free from TLR, target vessel revascularization, or major adverse cardiac events between the 2 groups at 5 years. Sirolimus-eluting stent is a viable treatment option compared with VBT for BMS restenosis.

Percutaneous left ventricular assist device with TandemHeart for high-risk percutaneous coronary intervention: the Mayo Clinic experience.

BACKGROUND: In patients with poor left ventricular function and severe left main or multivessel coronary disease, coronary artery bypass grafting (CABG) surgery has been the preferred therapy. However, a number of these patients are either inoperable or poor surgical candidates due to comorbid conditions and previous cardiac surgical procedures. These patients are generally poor candidates for standard percutaneous coronary intervention (PCI) techniques. A hybrid PCI approach with hemodynamic support may be a viable strategy for these patients. We report our experience using the TandemHeart percutaneous left ventricular assist device during high-risk PCI. METHODS: Retrospective cross-sectional analysis of prospectively collected data in 54 patients undergoing high-risk PCI using the TandemHeart device for support. Hemodynamic and clinical data were collected and analyzed. RESULTS: Baseline clinical characteristics were as follows: mean age 72 ± 1.7 years, males 78%, median ejection fraction 20%, mean serum creatinine 1.6 ± 0.3 2 mg/dL, recent myocardial infarction 52%, COPD 33%, previous CABG 50%, diabetes mellitus 41%, and hypertension 83%. The median SYNTAX score was 33, and the median Jeopardy score was 10. The predicted surgical revascularization mortality was 13% by the Society for Thoracic Surgery risk score and 33% by Euroscore. There was a significant decrease in right and left heart pressures (P < 0.05) with a concomitant increase in the cardiac output from 4.7 to 5.7 L/min (P = 0.03) during TandemHeart support. Left main and multivessel PCI was performed in 62% of patients, and rotablation was used in 48%. Procedural success rate was 97%, whereas 30-day and 6 month survival were 90% and 87%, respectively. Major vascular complications occurred in 13% of cases. None of our patients developed contrast induced nephropathy or needed dialysis. CONCLUSIONS: High-risk PCI with percutaneous left ventricular support using TandemHeart is a viable therapeutic strategy for a select subset of patients at very high risk with standard percutaneous revascularization techniques.

Transcatheter aortic valve implantation: assessing the learning curve.

OBJECTIVES: The aim of this study was to assess the learning curve for the implantation of the percutaneous aortic valve via the transfemoral route. BACKGROUND: Transcutaneous aortic valve insertion is a fundamentally new procedure for the treatment of aortic valve stenosis. The number of cases needed to gain proficiency with concomitant ease and familiarity (i.e., the "learning curve") with the procedure is unknown. METHODS: We performed a retrospective analysis of the first 44 consecutive patients who underwent transcatheter aortic valve implantation as part of the PARTNER (Placement of Aortic Transcatheter Valves) trial at our institution between November 2008 and May 2011. RESULTS: The median age of the patients was 83 years (interquartile range: 77 to 87 years) and a median Society of Thoracic Surgery risk score of 9.6. Pre-procedural assessment of the aortic valve revealed a mean gradient of 53.5 mm Hg, mean aortic valve area of 0.7 mm(2), and a median ejection fraction of 59.5%. Patients were divided into tertiles based on sequence. Significant decreases in median contrast volume (180 to 160 to 130 ml, p = 0.003), valvuloplasty to valve deployment time (12.0 to 11.6 to 7.0 min, p < 0.001) and fluoroscopy times, from 26.1 to 17.2 and 14.3 min occurred from tertiles 1 to 3, p < 0.001. Significant decreases in radiation doses were also seen across the 3 tertiles, p < 0.001. The 30-day mortality for the entire cohort was 11%. CONCLUSIONS: Experience accumulated over 44 transfemoral aortic valve implantations led to significant decreases in procedural times, radiation, and contrast volumes. Our data show increasing proficiency with evidence of plateau after the first 30 cases. More studies are needed to confirm these findings.