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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.
Subject(s)
Mitral Valve Insufficiency , Humans , Treatment Outcome , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Hospitalization , Registries , TechnologyABSTRACT
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.
Subject(s)
Catheters , Heart Valves , Female , Humans , Retrospective Studies , Treatment Outcome , Hospital MortalityABSTRACT
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.
Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Ventricular Dysfunction, Left , Female , Humans , Retrospective Studies , Stroke Volume , Quality of Life , Risk Factors , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Transcatheter Aortic Valve Replacement/adverse effects , Ventricular Dysfunction, Left/etiology , Treatment Outcome , Prosthesis DesignABSTRACT
BACKGROUND: The incidence of patients with previous history of coronary artery bypass grafting (CABG) presenting for aortic valvular replacement has been consistently on the rise. Repeat sternotomy for surgical aortic valve replacement (SAVR) carries an inherent risk of morbidity and mortality when compared to Transcatheter aortic valve replacement (TAVR). METHODS: The Nationwide inpatient sample (NIS) from 2012 to 2014 was queried using the International Classification of Diseases-Ninth edition, Clinical Modification (ICD-9-CM) codes to identify all patients ≥ 18 years with prior CABG who underwent TAVR (35.05 and 35.06) or SAVR (35.21 and 35.22). Propensity score matching (1:1) was performed and in-hospital outcomes were compared between matched cohorts. RESULTS: From 2012 to 2014, there was progressive increase in the annual number of TAVR procedures from 1485 to 4020, with a decrease in patients undergoing SAVR from 2330 to 1955 (Ptrend < 0.0001) in the above population. There was no significant difference in in-hospital mortality rates. Compared to SAVR, TAVR was associated with lower risk of stroke (1.2% vs. 3.3%, P = 0.009), AKI (12.9% vs. 21.3%, P < 0.0001), myocardial infarction (0.9% vs. 2.7%, P = 0.01) and major bleeding (9.1% vs. 25.1%, P < 0.0001). TAVR was associated with higher risk of pacemaker implants (9.6% vs. 4.9%, P = 0.001) and trend toward lower risk of vascular complications (2.3% vs. 4.1%, P = 0.05). CONCLUSION: In this large cohort of patients with previous CABG, there is no significant difference in in-hospital mortality between TAVR and SAVR. TAVR was associated with lower risk of in-hospital outcomes.
Subject(s)
Coronary Artery Bypass , Coronary Artery Disease/surgery , Heart Valve Diseases/surgery , Heart Valve Prosthesis Implantation , Sternotomy , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass/mortality , Coronary Artery Disease/mortality , Databases, Factual , Female , Heart Valve Diseases/mortality , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/mortality , Heart Valve Prosthesis Implantation/trends , Hospital Mortality , Humans , Inpatients , Male , Postoperative Complications/mortality , Postoperative Complications/therapy , Retrospective Studies , Risk Assessment , Risk Factors , Sternotomy/adverse effects , Sternotomy/mortality , Sternotomy/trends , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Transcatheter Aortic Valve Replacement/trends , Treatment Outcome , United States/epidemiologyABSTRACT
BACKGROUND: Bioprosthetic (BP) valves have been increasingly used for aortic valve replacement over the last decade. Due to their limited durability, patients presenting with failed BP valves are rising. Valve in Valve - Transcatheter Aortic Valve Implantation (ViV-TAVI) emerged as an alternative to the gold standard redo-Surgical Aortic Valve Replacement (redo-SAVR). However, the utility of ViV-TAVI is poorly understood. METHODS: A systematic electronic search of the scientific literature was done in PubMed, EMBASE, SCOPUS, Google Scholar, and ClinicalTrials.gov. Only studies which compared the safety and efficacy of ViV-TAVI and redo-SAVR head to head in failed BP valves were included. RESULTS: Six observational studies were eligible and included 594 patients, of whom 255 underwent ViV- TAVI and 339 underwent redo-SAVR. There was no significant difference between ViV-TAVI and redo- SAVR for procedural, 30 day and 1 year mortality rates. ViV-TAVI was associated with lower risk of permanent pacemaker implantation (PPI) (OR: 0.43, CI: 0.21-0.89; P = 0.02) and a trend toward increased risk of paravalvular leak (PVL) (OR: 5.45, CI: 0.94-31.58; P = 0.06). There was no significant difference for stroke, major bleeding, vascular complications and postprocedural aortic valvular gradients more than 20 mm-hg. CONCLUSION: Our results reiterate the safety and feasibility of ViV-TAVI for failed aortic BP valves in patients deemed to be at high risk for surgery. VIV-TAVI was associated with lower risk of permanent pacemaker implantation with a trend toward increased risk of paravalvular leak.
Subject(s)
Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation , Postoperative Complications , Transcatheter Aortic Valve Replacement , Aortic Valve/surgery , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/methods , Humans , Postoperative Complications/etiology , Postoperative Complications/therapy , Prosthesis Design , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/instrumentation , Transcatheter Aortic Valve Replacement/methods , Treatment OutcomeABSTRACT
Background: Hemostasis for transfemoral transcatheter aortic valve replacement (TAVR) is typically achieved using a suture-mediated vascular closure device (VCD) prior to large-bore sheath insertion (preclosure technique). Recently, the addition of a hybrid closure technique using a preclose technique with the addition of a collagen-plug VCD after sheath removal in cases of failed hemostasis has been utilized. Methods: Data were collected from the Northwell TAVR registry, including 3 high-volume TAVR centers. We evaluated a preclose strategy with suture-mediated vascular closure alone ("legacy strategy") and standard bailout techniques versus a contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout. The primary end point was major or minor vascular complications as defined by the VARC-3 criteria. Results: A total of 1327 patients were included, of which 791 patients underwent TAVR with suture-mediated closure alone and 536 with contemporary strategy. The primary end point (major or minor vascular complication) was lower in the contemporary strategy (5.44% vs 1.31%; P < .001). Both minor (3.92% vs 1.12%; P = .002) and major (1.14% vs 0.19%; P = .0196) vascular complications were reduced and the total length of stay was less in the contemporary strategy (median of 3 days vs 2 days; P < .0001). Using multivariable analysis, we observed that vascular management strategy significantly improved the composite primary outcome when adjusted for sheath size, peripheral artery disease, carotid disease, and site of procedure. In the contemporary group, bailout collagen-plug VCD with an Angio-Seal (Terumo Medical) was used in 68 patients (12.69%) and bailout MANTA (Teleflex) was required in 4 patients (0.75%). There were no major or minor vascular complications among the patients who received bailout collagen-plug VCD. Conclusions: A contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout reduces the risk of vascular complications among patients undergoing transfemoral TAVR.
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Supplemental oxygen administration is a delicate balance in managing chronic obstructive pulmonary disease (COPD), where the risk of exacerbating hypercapnia must be carefully considered. This case report describes a 69-year-old male with COPD who, after self-medicating with commercially available portable oxygen bottles, experienced hypercapnic respiratory failure and severe respiratory acidosis, leading to intensive care unit (ICU) admission and non-invasive ventilation. The patient's unsupervised use of commercially available portable oxygen bottles emphasizes the risks associated with unregulated supplemental oxygen in COPD. This case highlights the critical importance of cautious oxygen supplementation in COPD, urging high-risk patients to seek medical guidance, even with over-the-counter products. This case emphasizes the need for expert medical opinion to ensure safe oxygen use in vulnerable populations.
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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.
Subject(s)
Aortic Valve Stenosis , Coronary Artery Disease , Percutaneous Coronary Intervention , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Percutaneous Coronary Intervention/adverse effects , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/surgery , Retrospective Studies , Stroke Volume , Treatment Outcome , Ventricular Function, Left , Coronary Artery Disease/complications , Coronary Artery Disease/diagnosis , Coronary Artery Disease/surgery , Aortic Valve/surgery , Risk FactorsABSTRACT
Background: Severe tricuspid regurgitation (TR) may persist after a mitral transcatheter edge-to-edge repair (M-TEER) and is associated with worsened clinical outcomes and survival. It is unclear which patients with concomitant mitral regurgitation (MR) and TR will have TR reduction after M-TEER. The aim of this study was to identify the predictors of residual TR after transcatheter edge-to-edge repair (TEER). Methods: Data were collected from the Northwell TEER registry, a prospectively maintained mandatory database including 4 high-volume transcatheter aortic valve replacement/TEER centers. Transthoracic echocardiograms, both pre-TEER and post-TEER, were evaluated. Univariate and multivariate logistic regression analyses were performed to identify predictors of severe TR after M-TEER. Significant TR reduction was defined as a reduction in TR grade by at least 1+ with moderate (2+) or less TR at 1 month. Results: Of the 479 patients who underwent M-TEER, 107 patients with concomitant severe MR/TR were included. Successful MR reduction occurred in 89 patients (84%) and a significant TR reduction in 45 (42%). On the univariate analysis, the only predictors of severe residual TR were right atrial area and unsuccessful M-TEER. On the multivariate logistic regression model, the only predictor variable for patients with a reduction in TR was MR reduction of ≥3+ with M-TEER. Conclusions: In patients with concomitant severe MR and TR, TR reduction after isolated M-TEER occurs in only â¼40% of patients. MR grade reduction ≥3+ was the only independent predictor for TR reduction. Other clinical and echocardiographic variables (including pulmonary hypertension, right ventricular function, tricuspid annular dilation, atrial fibrillation, and presence of a cardiac implantable electrical device) were not associated with residual TR. Inability to predict TR reduction after M-TEER highlights the importance of establishing transcatheter tricuspid valve therapies and should factor in heart-team discussions.
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We compared stroke rates associated with coronary artery bypass grafting (CABG), both on-pump and off-pump, and percutaneous coronary intervention (PCI) with both drug-eluting stent (DES) and bare-metal stent (BMS) and the impact on 30-day and 1-year all-cause mortality. The Myocardial Infarction Data Acquisition System database was used to study patients who had on-pump CABG (n = 47,254), off-pump CABG (n = 19,118), and PCI with BMS (n = 46,641), and DES (n = 115,942) in New Jersey from 2002 to 2012. Multiple logistic and Cox proportional hazard models were used to compare the risk of stroke and mortality. Adjustments were made for demographics, year of hospitalization, and co-morbidities. The rate of postprocedural stroke was lowest with DES (0.5%), followed by BMS (0.6%), off-pump CABG (1.3%), and on-pump CABG (1.8%). After adjustment, on-pump CABG had a higher risk of stroke compared with off-pump (odds ratio 1.36, 95% CI 1.18 to 1.56, p <0.0001). DES had lower risk of stroke compared with off-pump CABG (odds ratio 0.64, 95% CI 0.55 to 0.74, p <0.0001). There was a significant excess risk of 1-year mortality due to the interaction between stroke and procedure type (on-pump vs off-pump CABG and PCI with DES vs BMS; p value for interaction = 0.02). In conclusion, in this retrospective analysis of nonrandomized data from a statewide database, PCI with DES was associated with the lowest rate of postprocedural stroke, and off-pump CABG had a lower rate of postprocedural stroke than on-pump CABG; there was an excess 1-year mortality risk with on-pump versus off-pump CABG and with DES versus BMS in patients with stroke.
Subject(s)
Coronary Artery Bypass/adverse effects , Myocardial Infarction/surgery , Percutaneous Coronary Intervention/adverse effects , Postoperative Complications/epidemiology , Stents/adverse effects , Stroke/epidemiology , Aged , Female , Humans , Logistic Models , Male , Middle Aged , Myocardial Infarction/complications , Myocardial Infarction/mortality , Proportional Hazards Models , Retrospective StudiesABSTRACT
INTRODUCTION: Impella is a catheter-based micro-axial flow pump placed across the aortic valve, and it is currently the only percutaneous left ventricular assist device approved for high-risk percutaneous coronary intervention and cardiogenic shock. Areas Covered: Even though several studies have repeatedly demonstrated the excellent hemodynamic profile of Impella in high-risk settings, it remains underutilized. Here we aim to provide an up-to-date summary of the available literature on Impellas use in High risk settings as well as the practical aspects of its usage. Expert Commentary: Percutaneous coronary interventions in high rsk settings have always been challenging for a physician. Impella 2.5 and CP, have been proven safe, cost effective and feasible in High Risk Percutaneous coronary Interventions with an excellent hemodynamic profile.
Subject(s)
Heart-Assist Devices , Percutaneous Coronary Intervention/instrumentation , Shock, Cardiogenic/therapy , Contraindications, Procedure , Cost-Benefit Analysis , Heart-Assist Devices/adverse effects , Hemodynamics , Humans , Medical Illustration , Percutaneous Coronary Intervention/methodsABSTRACT
Diaphragmatic paralysis (DP) is a common condition. It can be unilateral or bilateral and the diagnosis is usually based on a clinical and radiological findings. Bilateral diaphragmatic paralysis is usually symptomatic with dyspnea and acute respiratory failure while unilateral diaphragmatic paralysis is typically asymptomatic and when present, symptoms usually depend on the presence of underlying pulmonary or neurologic disease. DP can be the result of various chest conditions that affect the phrenic nerve such as tumors, vascular abnormalities or traumatic incidents during surgery as well as blunt or penetrating chest or neck injuries. We report a unique case of phrenic nerve injury and unilateral diaphragmatic paralysis secondary to pacemaker pulse generator replacement that was successfully treated with diaphragmatic plication.