Contemporary experience of mitral transcatheter edge-to-edge repair technology in patients with mitral annular calcification.

BACKGROUND: Mitral annular calcification (MAC) has been an exclusion for many of the earlier pivotal trials that were instrumental in gaining device approval and indications for mitral transcatheter edge-to-edge repair (M-TEER). AIMS: To evaluate the impact of MAC on the procedural durability and success of newer generation MitraClip® systems (G3 and G4 systems). METHODS: Data were collected from Northwell TEER registry. Patients that underwent M-TEER with third or fourth generation MitraClip device were included. Patients were divided into -MAC (none-mild) and +MAC (moderate-severe) groups. Procedural success was defined as ≤ grade 2 + mitral regurgitation (MR) postprocedure, and durability was defined as ≤ grade 2 + MR retention at 1 month and 1 year. Univariate analysis compared outcomes between groups. RESULTS: Of 260 M-TEER patients, 160 were -MAC and 100 were +MAC. Procedural success was comparable; however, there were three patients who required conversion to cardiac surgery during the index hospitalization in the +MAC group versus none in the -MAC group (though this was not statistically significant). At 1-month follow-up, there were no significant differences in MR severity. At 1-year follow-up, +MAC had higher moderate-severe MR (22.1% vs. 7.5%; p = 0.002) and higher mean transmitral gradients (5.3 vs. 4.0 mmHg; p = 0.001) with no differences in mortality, New York Heart Association functional class or ejection fraction. CONCLUSION: In selective patients with high burden of MAC, contemporary M-TEER is safe, and procedural success is similar to patients with none-mild MAC. However, a loss of procedural durability was seen in +MAC group at 1-year follow-up. Further studies with longer follow-ups are required to assess newer mTEER devices and their potential clinical implications in patients with a high burden of MAC.

Comparison of clinical outcomes between use of overexpanding an undersized versus nominal-sized SAPIEN 3 ultra transcatheter heart valve in patients with borderline annulus area.

BACKGROUND: For patients with borderline annulus areas that fall between two valve sizes, overinflating a smaller balloon-expandable transcatheter heart valve (THV) may be preferable to nominal sizing of a larger THV. OBJECTIVES: To evaluate the outcomes of nominal preparation versus over-expanding an under-sized SAPIEN 3 Ultra (S3U) transcatheter heart valve (OE-THV) in cases with borderline annuli. METHODS: 958 patients that underwent TAVR with the S3U at four high-volume TAVR centers between January 2017 and December 2020 were retrospectively reviewed. 336 patients were identified as borderline annuli size, of which 146 (44%) received OE-THVs and 190 (56%) received nominal-sized THVs. The primary composite endpoint included: in-hospital mortality, aortic injury, moderate/severe paravalvular leak (PVL), permanent pacemaker implant (PPM), stroke, or conversion to surgery. RESULTS: Baseline characteristics were similar except for a larger percentage of females in the OE-THV (53.42% vs. 42.11%, p = 0.04). TAVR with OE-THV resulted a reduction in the primary composite endpoint (13.69% vs. 22.63%, p = 0.04). On subgroup analysis, there was no difference between 20 mm OE-THV versus 23 mm nominal or 23 mm OE-THV versus 26 mm nominal, but there was a reduction in the primary composite endpoint in patients with larger annuli that received a 26 mm OE-THV compared to the 29 mm nominally sized THV (9.7% vs. 27.4%, p = 0.02). At 1 month and 1 year follow-up, there was no significant difference in mortality, PVL rates, NYHA class, and/or KCCQ score. CONCLUSION: Overinflating a smaller-sized S3U THV may be a safer option in comparison to nominal sizing in patients with borderline annular area.

Transcatheter heart valve selection in patients with low ejection fraction and aortic stenosis.

OBJECTIVE: The aim of this study was to compare outcomes of transcatheter heart valve (THV) choice in patients with left ventricular (LV) systolic dysfunction. BACKGROUND: The management congestive heart failure with combined LV systolic dysfunction and severe aortic stenosis (AS) is challenging, yet transcatheter aortic valve replacement (TAVR) has emerged as a suitable treatment option in such patients. Head-to-head comparisons among the balloon-expandable (BEV) and self-expandable (SEV) THV remain limited in this subgroup of patients. METHODS: In this retrospective study, we included patients with severe AS with LV systolic dysfunction (LVEF ≤40%) who underwent TAVR at four high volume centers. Two thousand and twenty-eight consecutive patients were analyzed, of which 335 patients met inclusion criteria. One hundred fourty-six patients (43%) received a SEV, and 189 patients (57%) received a BEV. RESULTS: Baseline characteristics were similar except for a higher proportion of females in the SEV group. The primary composite endpoint of in-hospital mortality, moderate or greater paravalvular (PVL), stroke, conversion to open surgery, aortic valve reintervention, and/or need for permanent pacemaker (PPM) was no different among THV choice. There was more PVL in the SEV group, but higher transaortic gradients in the BEV group. Clinical outcomes and quality of life measures were similar up to 1 year follow-up. CONCLUSION: The choice of THV in patients with severe AS and systolic dysfunction must be weighed on a case-by-case basis.

Continuous invasive hemodynamic monitoring using steerable guide catheter to optimize mitraclip transcatheter mitral valve repair: A multicenter, proof-of-concept study.

OBJECTIVES: We report our multicenter experience on continuous hemodynamic monitoring using exclusively the steerable guide catheter (SGC) during MitraClip repair. BACKGROUND: Left atrial pressure (LAP) and V-wave are useful to evaluate MitraClip repair but no simple method of continuous monitoring exists. METHODS: From 11/2016 to 8/2017, 74 patients from four centers with symptomatic moderate-severe to severe mitral regurgitation (MR), underwent MitraClip NT repair with continuous hemodynamic monitoring via the SGC. Real-time LAP/V-wave changes were compared with transesophageal echocardiography (TEE). When mitral stenosis was suspected, transmitral gradients were verified by invasive hemodynamics. Clinical and echocardiographic outcomes were determined. RESULTS: Mean age was 78 ± 10 years and STS score 9.1 ± 11.0%. Pathology included leaflet prolapse/flail (45%), restriction (35%), and mixed (20%). Number of clips averaged 1.7 ± 0.7 per case. There was a significant reduction in LAP (21 ± 10 to 15 ± 7 mmHg, P < 0.0001) and V-wave(37 ± 19 to 24 ± 10 mmHg, P < 0.0001) post MitraClip, but the decrease was less in patients with atrial fibrillation (P < 0.05). Transmitral gradient significantly increased from 2.0 ± 1.2 to 4.0 ± 1.7 mmHg (P < 0.0001). Paradoxical increases in LAP and V-wave despite MR reduction were observed in three cases requiring MitraClip repositioning or retrieval to avoid stenosis. Follow-up averaged 5.0 ± 2.9 months and was 100% complete. KCCQ improvement was significant and MR reduction to <1+ was 67% and <2+ was 93% at 30 days. CONCLUSIONS: Continuous hemodynamic monitoring using the SGC complements TEE to assess and optimize MitraClip repair in real-time. Further validation is necessary but this feature may be part of future MitraClip and other transcatheter mitral repair systems.

The utility and impact of outpatient telemetry monitoring in post-transcatheter aortic valve replacement patients.

BACKGROUND: Conduction disturbances are a common complication of transcatheter aortic valve replacement (TAVR). Mobile Cardiac Telemetry (MCT) allows for continuous monitoring with near "real time" alerts and has allowed for timely detection of conduction abnormalities and pacemaker placement in small trials. A standardized, systematic approach utilizing MCT devices post TAVR has not been widely implemented, leading to variation in use across hospital systems. OBJECTIVES: Our aim was to evaluate the utility of a standardized, systematic approach utilizing routine MCT to facilitate safe and earlier discharge by identifying conduction disturbances requiring permanent pacemaker (PPM) placement. We also sought to assess the occurrence of actionable arrhythmias in post-TAVR patients. METHODS: Using guidance from the JACC Scientific Expert Panel, a protocol was implemented starting in December 2019 to guide PPM placement post-TAVR across our health system. All patients who underwent TAVR from December 2019 to June 2021 across four hospitals within Northwell Health, who did not receive or have a pre-existing PPM received an MCT device at discharge and were monitored for 30 days. Clinical and follow-up data were collected and compared to pre initiative patients. RESULTS: During the initiative 693 patients were monitored with MCT upon discharge, 21 of whom required PPM placement. Eight of these patients had no conduction abnormality on initial or discharge ECG. 59 (8.6 %) patients were found to have new atrial fibrillation or flutter via MCT monitoring. There were no adverse events in the initiative group. Prior to the initiative, 1281 patients underwent TAVR over a one-year period. The initiative group had significantly shorter length of stay than pre-initiative patients (2.5 ± 4.5 vs 3.0 ± 3.8 days, p < 0.001) and lower overall PPM placement rate within 30 days post-TAVR (16 % vs 20.5 %, P = 0.0125). CONCLUSIONS: In our study, implementation of a standardized, systematic approach utilizing MCT in post-TAVR patients was safe and allowed for timely detection of conduction abnormalities requiring pacemaker placement. This strategy also detected new atrial fibrillation and flutter. Reduction in post TAVR pacemaker rate and length of stay were also noted although this effect is multifactorial.

Hemodialysis catheter-related right atrial thrombus treated with the FlowTriever system.

Tunneled catheters are frequently used in patients with end-stage renal disease who require hemodialysis access. Catheter-related atrial thrombus is a documented complication of prolonged catheter use. The incidence of catheter-related atrial thrombus is 2% to 29%, with a high mortality rate approaching 20%, raising concerns for serious complications and death in the absence of an established universal management plan. This case series demonstrates the successful use of a minimally invasive approach to treat patients with intracardiac thrombus and high perioperative risk factors using mechanical and aspiration thrombectomy with the FlowTriever system (Inari Medical).

Short- and Mid-Term Outcomes of Complex and High-Risk Versus Standard Percutaneous Coronary Interventions in Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: The prevalence of coronary artery disease (CAD) in patients undergoing TAVR varies and is associated with increased morbidity and mortality. We evaluated the outcomes of complex and high-risk percutaneous coronary interventions (CHIP-PCIs) and TAVR compared with standard PCI and TAVR. Between January 2014 and March 2021, a total of 276 consecutive patients with severe aortic stenosis (AS) who underwent TAVR and PCI at 3 centers within Northwell Health were retrospectively reviewed. CHIP-PCI was defined as PCI with one of the following: left ventricular ejection fraction (LVEF) <30%; left main coronary artery (LMCA)/chronic total occlusion (CTO) intervention; atherectomy; or need for left ventricular (LV) support. One hundred twenty- seven patients (46%) had CHIP-PCI prior to TAVR and 149 patients (54%) had standard PCI. Thirteen percent of CHIP-PCI and 22% of standard PCI cases were done concomitantly with TAVR. CHIP-PCI criteria were met for low EF (19%), LMCA (25%), CTO (3%), LV support (20%), and atherectomy (50%). The types of valves used were similarly divided (49% balloon expandable vs 51% self expanding. Major adverse cardiac or cerebrovascular event (MACCE) rate for CHIP-PCI/TAVR was 4.9% at 30 days vs 1.3% for standard PCI/TAVR (P=.09), driven by in-hospital stroke. At 1 year, the rates of MACCE for CHIP-PCI/TAVR remained higher than for standard PCI/TAVR, but was not statistically significant (8.7% vs 4%; P=.06), driven by revascularization. We found no differences between major and/or minor vascular complications. New York Heart Association classification at 1 month was similar (I/II 93% vs 95%; P=.87). Our study suggests that CHIP-PCI can be safely performed in patients with complex CAD and concomitant severe AS.

Acute surgical pulmonary embolectomy: a 9-year retrospective analysis.

Acute pulmonary embolism is a substantial cause of morbidity and death. Although the American College of Chest Physicians Evidence-Based Clinical Practice Guidelines recommend surgical pulmonary embolectomy in patients with acute pulmonary embolism associated with hypotension, there are few reports of 30-day mortality rates. We performed a retrospective review of acute pulmonary embolectomy procedures performed in 96 consecutive patients who had severe, globally hypokinetic right ventricular dysfunction as determined by transthoracic echocardiography. Data on patients who were treated from January 2003 through December 2011 were derived from health system databases of the New York State Cardiac Surgery Reporting System and the Society of Thoracic Surgeons. The data represent procedures performed at 3 tertiary care facilities within a large health system operating in the New York City metropolitan area. The overall 30-day mortality rate was 4.2%. Most patients (68 [73.9%]) were discharged home or to rehabilitation facilities (23 [25%]). Hemodynamically stable patients with severe, globally hypokinetic right ventricular dysfunction had a 30-day mortality rate of 1.4%, with a postoperative mean length of stay of 9.1 days. Comparable findings for hemodynamically unstable patients were 12.5% and 13.4 days, respectively. Acute pulmonary embolectomy can be a viable procedure for patients with severe, globally hypokinetic right ventricular dysfunction, with or without hemodynamic compromise; however, caution is warranted. Our outcomes might be dependent upon institutional capability, experience, surgical ability, and careful patient selection.

Autologous repair of supravalvar pulmonic stenosis.

Native supravalvar pulmonary stenosis is a rare anomaly, but iatrogenic supravalvar pulmonary stenosis occurs after various repairs for congenital heart disease with relative frequency. Surgical techniques such as patching carry the risk of restenosis. We describe a technique of repair using only autologous tissues that can be applied to both native and iatrogenic supravalvar pulmonary stenosis. There were no complications and no patient developed restenosis at follow-up. Autologous repair of supravalvar pulmonary stenosis is an effective technique.

Robot-assisted off-pump minimally invasive reoperative coronary artery bypass grafting: case report.

BACKGROUND: Resternotomy for reoperative coronary artery bypass grafting (CABG) has become increasingly common with an aging patient population. Minimally invasive and robotic techniques permit us to perform these surgeries with reduced morbidity and mortality. CASE REPORT: A 67-year-old woman was taken to the operating room for repeat CABG. A free right internal mammary graft was endoscopically harvested using the da Vinci robotic operating system. A small left thoracotomy was then used to perform an off-pump bypass from the descending aorta to the hood of a diseased saphenous vein graft. CONCLUSION: Robotic and minimally invasive cardiac surgery undergoes continuous refinement. As the incidence of reoperative surgery in patients with multiple previous interventions rises, surgeons will have to become increasingly creative with their choice of conduits, incisions, and the use of hybrid open and endoscopic techniques.

Management of malignant pleural effusions using the Pleur(x) catheter.

BACKGROUND: A malignant pleural effusion can cause significant morbidity to terminal patients. Drainage and control of the fluid can provide great palliation. Improving the quality of life for these patients on an outpatient basis is a worthy goal. METHODS: We have inserted 231 Pleur(x) (Cardinal Health Systems, McGaw Park, IL) catheters into 202 patients with symptomatic malignant pleural effusions with the goal of treating the fluid on an outpatient basis. The catheters were drained at home, using vacuum bottles, every other day after an initial week of draining daily. No sclerosing agents were instilled. The catheters were removed when drainage was less than 50 mL/day. Primary tumor sites, irradiation to the hemithorax, and incomplete re-expansion of the lung were studied for their ability to predict prolonged drainage (over 100 days). RESULTS: In all cases, evacuation of the fluid with a Pleur(x) catheter palliated the patient's symptoms. Overall, 134 of 231 (58.0%) catheters were removed after the drainage tapered off. Reaccumulation of the pleural effusion occurred in 5 of 132 (3.8%) patients. The incidence of infection was 5 of 231 (2.2%) and was usually limited to cellulitis at the insertion site. The incidence of blockage was 11 of 231 (4.8%) and was most common in patients with an underlying cancer at sites other than breast and gynecologic primaries. Drainage for more than 100 days was seen most often in patients who had incomplete reexpansion of the underlying lung (p < 0.001). Primary tumor site and irradiation did not have significant predictive value. CONCLUSIONS: Insertion of Pleur(x) catheters is an effective way to treat patients with a malignant pleural effusion on an outpatient basis with a high degree of patient compliance and few complications. Overall, almost 60% of the catheters can be removed with a very low chance of reaccumulation, and without the need to instill a sclerosing agent. Even patients with a trapped lung can be palliated and released from hospital, although the likelihood of removing the catheter is small.