Minimizing radiographic contrast administration during coronary angiography using a novel contrast reduction system: A multicenter observational study of the DyeVert™ plus contrast reduction system.

OBJECTIVE: To evaluate contrast media (CM) volume (CMV) saved using the DyeVert™ Plus Contrast Reduction System (DyeVert Plus System, Osprey Medical) in patients undergoing diagnostic coronary angiogram (CAG) and/or percutaneous coronary interventional (PCI) procedures performed with manual injections. BACKGROUND: Current guidelines advocate for monitoring and minimization of the total volume of CM in chronic kidney disease (CKD) patients undergoing invasive cardiac procedures. The DyeVert Plus System is an FDA cleared device designed to reduce CMV delivered during angiography and permit real-time CMV monitoring. METHODS: We performed a multicenter, single-arm, observational study. Eligible subjects were ≥ 18 years old with baseline estimated glomerular filtration rate (eGFR) 20-60 mL/min/1.73 m2 . The primary endpoint was % CMV saved over the total procedure. A secondary objective was to evaluate adverse events (AEs) related to DyeVert Plus System or to CM use. RESULTS: A total of 114 subjects were enrolled at eight centers. Mean age was 72 ± 9 years, 72% were male, and mean body mass index was 29 ± 5. Baseline eGFR was 43 ± 11 mL/min/1.73 m2 . CAG-only was performed in 65% of cases. One hundred and five subjects were evaluable for the primary endpoint. Mean CMV attempted was 112 ± 85 mL (range 22-681) and mean CMV delivered was 67 ± 51 mL (range 12-403), resulting in an overall CMV savings of 40.1 ± 8.8% (95% CI 38.4, 41.8; P < 0.0001) per procedure. Image quality was maintained in all but one case where the system was turned off for one injection. No DyeVert Plus System-related AEs were reported. Acute kidney injury (AKI; defined as serum creatinine rise of >0.3 mg/dL from baseline) was reported in 11 cases with seven occurring in subjects with baseline eGFR < 30 and three AKI events were attributed to CM. AKI rates increased as CMV/eGFR ratios increased. CONCLUSIONS: These data suggest DyeVert Plus System use in CKD patients undergoing CAG and/or PCI results in clinically meaningful CMV savings while maintaining image quality.

Mitral valve repair after annuloplasty ring dehiscence using MitraClip.

Dehiscence of a surgical mitral annuloplasty ring for repair of functional mitral regurgitation (MR) is an infrequently reported complication that often manifests as recurrent MR and heart failure. Re-do mitral valve surgery to correct ring dehiscence may not be feasible for patients at high risk of operative mortality or serious morbidity. We report two cases of mitral annular ring dehiscence and severe mitral regurgitation in patients at prohibitive risk for re-do mitral valve surgery who were successfully treated with MitraClip. © 2015 Wiley Periodicals, Inc.

Transcatheter Paravalvular Leak Closure With Covered Stent Tract and Vascular Plug: Tootsie Roll Technique.

BACKGROUND: Transcatheter closure of transcatheter heart valve (THV)-related paravalvular leak (PVL) is associated with a high failure rate with available devices due to the complex interaction of THV and aortic/mitral annulus. OBJECTIVES: This study reports on novel transcatheter techniques to treat PVL after THV. METHODS: The authors describe consecutive patients who underwent PVL closure after transcatheter aortic valve replacement (TAVR) or transcatheter mitral valve replacement (TMVR). A covered self-expanding stent (Viabahn) was deployed in the defect to create a seal between the THV and annulus. A vascular plug (Amplatzer Vascular Plug 2 [AVP2] or AVP4) was then deployed inside the covered stent to obliterate PVL. RESULTS: Eight patients with THV-related PVL were treated using this method (aortic [3 SAPIEN, 1 Evolut], mitral [2 SAPIEN-in-MAC (mitral annular calcification), 2 M3 TMVR). Various combinations of stents and plugs were used (5 mm × 2.5 cm Viabahn + 6 mm AVP4 [n = 2], 8 mm × 2.5 cm Viabahn + 10 mm AVP2 [n = 5], and 10 mm × 5.0 cm Viabahn + 12 mm AVP2 [n = 1]). All had technical success with immediate elimination of target PVL, without in-hospital complications. None had signs of postprocedure hemolysis. All patients were discharged alive (median 3.5 days [Q1-Q3: 1.0-4.8 days]). No residual PVL was seen at discharge, except for 1 patient with mild regurgitation due to another untreated PVL location. One patient died before 30 days due to complication of valve-in-MAC TMVR. In remaining patients, none had recurrence of PVL at 30 days. Symptoms decreased to NYHA functional class I/II in 6 patients. NYHA functional class III symptoms remained in 1 patient with mitral regurgitation awaiting subsequent valve replacement procedure. CONCLUSIONS: The technique of sequential deployment of a covered stent and vascular plug may effectively treat THV-related PVL.

Impact of Tricuspid Regurgitation on Outcomes After Transcatheter Mitral Valve Replacement.

Development of functional tricuspid regurgitation (TR) because of chronic mitral disease and subsequent heart failure is common. However, the effect of TR on clinical outcomes after transcatheter mitral valve replacement (TMVR) remains unclear. We aimed to evaluate the impact of baseline TR on outcomes after TMVR. This was a single-center, retrospective analysis of patients who received valve-in-valve or valve-in-ring TMVR between 2012 and 2022. Patients were categorized into none/mild TR and moderate/severe TR based on baseline echocardiography. The primary outcome was 3 years all-cause death and the secondary outcomes were in-hospital events. Of the 135 patients who underwent TMVR, 64 (47%) exhibited none/mild TR at baseline, whereas 71 (53%) demonstrated moderate/severe TR. There were no significant differences in in-hospital events between the groups. At 3 years, the moderate/severe TR group exhibited a significantly increased risk of all-cause death (adjusted hazard ratio 3.37, 95% confidence interval 1.35 to 8.41, p = 0.009). When patients with baseline moderate/severe TR were stratified by echocardiography at 30 days into improved (36%) and nonimproved (64%) TR groups, although limited by small sample size, there was no significant difference in 3-year all-cause mortality (p = 0.48). In conclusion, this study investigating the impact of baseline TR on clinical outcomes revealed that moderate/severe TR is prevalent in those who underwent TMVR and is an independent predictor of 3-year all-cause mortality. Earlier mitral valve intervention before the development of significant TR may play a pivotal role in improving outcomes after TMVR.

Transcatheter Myotomy to Reduce Left Ventricular Outflow Obstruction.

BACKGROUND: Left ventricular outflow tract (LVOT) obstruction is a source of morbidity in hypertrophic cardiomyopathy (HCM) and a life-threatening complication of transcatheter mitral valve replacement (TMVR) and transcatheter aortic valve replacement (TAVR). Available surgical and transcatheter approaches are limited by high surgical risk, unsuitable septal perforators, and heart block requiring permanent pacemakers. OBJECTIVES: The authors report the initial experience of a novel transcatheter electrosurgical procedure developed to mimic surgical myotomy. METHODS: We used septal scoring along midline endocardium (SESAME) to treat patients, on a compassionate basis, with symptomatic LVOT obstruction or to create space to facilitate TMVR or TAVR. RESULTS: In this single-center retrospective study between 2021 and 2023, 76 patients underwent SESAME. In total, 11 (14%) had classic HCM, and the remainder underwent SESAME to facilitate TMVR or TAVR. All had technically successful SESAME myocardial laceration. Measures to predict post-TMVR LVOT significantly improved (neo-LVOT 42 mm2 [Q1-Q3: 7-117 mm2] to 170 mm2 [Q1-Q3: 95-265 mm2]; P < 0.001; skirt-neo-LVOT 169 mm2 [Q1-Q3: 153-193 mm2] to 214 mm2 [Q1-Q3: 180-262 mm2]; P < 0.001). Among patients with HCM, SESAME significantly decreased invasive LVOT gradients (resting: 54 mm Hg [Q1-Q3: 40-70 mm Hg] to 29 mm Hg [Q1-Q3: 12-36 mm Hg]; P = 0.023; provoked 146 mm Hg [Q1-Q3: 100-180 mm Hg] to 85 mm Hg [Q1-Q3: 40-120 mm Hg]; P = 0.076). A total of 74 (97.4%) survived the procedure. Five experienced 3 of 76 (3.9%) iatrogenic ventricular septal defects that did not require repair and 3 of 76 (3.9%) ventricular free wall perforations. Neither occurred in patients treated for HCM. Permanent pacemakers were required in 4 of 76 (5.3%), including 2 after concomitant TAVR. Lacerations were stable and did not propagate after SESAME (remaining septum: 5.9 ± 3.3 mm to 6.1 ± 3.2 mm; P = 0.8). CONCLUSIONS: With further experience, SESAME may benefit patients requiring septal reduction therapy for obstructive hypertrophic cardiomyopathy as well as those with LVOT obstruction after heart valve replacement, and/or can help facilitate transcatheter valve implantation.

Hybrid Closure of Postinfarction Apical Ventricular Septal Defect Using Septal Occluder Device and Right Ventricular Free Wall: The Apical BASSINET Concept.

BACKGROUND: Postinfarction ventricular septal defect (VSD) is a catastrophic complication of myocardial infarction. Surgical repair still has poor outcomes. This report describes clinical outcomes after a novel hybrid transcatheter/surgical repair in patients with apical VSD. METHODS: Seven patients with postmyocardial infarction apical VSD underwent hybrid transcatheter repair via subxiphoid surgical access. A transcatheter occluder (Amplatzer Septal Occluder) with a trailing premounted suture was deployed through the right ventricular wall and through the ventricular septum into the left ventricular apex. The trailing suture was used to connect an anchor external to the right ventricular wall. Tension on the suture then collapses the right ventricular free wall against the septum and left ventricular occluder, thereby obliterating the VSD. Outcomes were compared with 9 patients who underwent surgical repair using either patch or primary suture closure. RESULTS: All patients had significant left-to-right shunt (Qp:Qs 2.5:1; interquartile range [IQR, 2.1-2.6] hybrid repair versus 2.0:1 [IQR, 2.0-2.5] surgical repair), and elevated right ventricular systolic pressure (62 [IQR, 46-71] versus 49 [IQR, 43-54] mm Hg, respectively). All had severely depressed stroke volume index (22 versus 21 mL/m2) with ≈45% in each group requiring mechanical support preprocedurally. The procedure was done 15 (IQR, 10-50) versus 24 (IQR, 10-134) days postmyocardial infarction, respectively. Both groups of patients underwent repair with technical success and without intraprocedural death. One patient in the hybrid group and 4 in the surgical group developed multiorgan failure. The hybrid group had a higher survival at discharge (86% versus 56%) and at 30 days (71% versus 56%), but similar at 1 year (57% versus 56%). During follow-up, 1 patient in each group required reintervention for residual VSD (hybrid: 9 months versus surgical: 5 days). CONCLUSIONS: Early intervention with a hybrid transcatheter/surgical repair may be a viable alternative to traditional surgery for postinfarction apical VSD.

Transfemoral Transcatheter Aortic Valve Replacement Using Fascia Iliaca Block as an Alternative Approach to Conscious Sedation as Compared to General Anesthesia.

BACKGROUND/PURPOSE: General Anesthesia (GA) and conscious sedation (CS) are anesthetics for transfemoral transcatheter aortic valve replacement (TF-TAVR). We compared TF-TAVR outcomes using a novel anesthetic approach with fascia iliaca block (FIB) plus minimal CS (MCS) versus GA. METHODS: This retrospective propensity-matched study included consecutive TF-TAVR patients from January 2013 to December 2017 and dichotomized into FIB-MCS vs. GA. Data were collected from electronic records, Society of Thoracic Surgery (STS) database, and the Transcatheter Valve Therapies (TVT) Registry. Primary endpoints were operating room (OR) time, intensive care unit (ICU) and hospital length of stay (LOS). Secondary endpoints were 30-day, 1-year mortality, quality of life, 30-day re-hospitalization rate, failure of FIB-MCS, and hospital safety outcomes. RESULTS: A total of 304 TF-TAVR patients; FIB-MCS (n = 219) vs. GA (n = 85). Propensity matched 162 patients; FIB-MCS (n = 108) vs. GA (n = 54). FIB-MCS had shorter OR time (197.6 ±â€¯56.3 vs. 248.2 ±â€¯46.3 min, p < 0.001), ICU (67.8 ±â€¯71.7 vs. 84.9 ±â€¯72.1 h, p = 0.004) and hospital LOS (3.2 ±â€¯3.7 vs. 5.9 ±â€¯3.5 d, p < 0.001). FIB-MCS had lower rate of blood transfusion. FIB-MCA vs. GA 30-day and 1-year mortality were similar in the entire (2.3 vs. 2.4%, p = 1.0; and 8.2 vs. 5.9%, p = 0.49) and matched cohorts (0 vs. 3.7%, p = 0.11 and 7.4 vs. 5.6%, p = 0.75). FIB-MCS were less likely to be re-hospitalized [Odd Ratio: 0.32, CI:0.13-0.76] and 2% to 3% higher KCCQ-12 score. CONCLUSION: TF-TAVR using FIB-MCS is feasible and safe with shorter OR time, ICU and hospital LOS, lower risk of 30-day re-hospitalization, similar 30-day and 1-year mortality with better quality of life at 1-year follow-up.

Clinical Conference Proceedings: 15th Biennial International Andreas Gruentzig Society Meeting.

The International Andreas Gruentzig Society is an educational society of physicians and scientists interested in cardiovascular and related fields. Members cooperate in the advancement of knowledge and education through research, publication, study, and teaching in the fields of cardiovascular disease. This summary reflects the proceedings from the recent scientific meeting to assess current clinical problems and propose future directions and possible solutions.

Emergency Valve-in-Valve Transcatheter Aortic Valve Implantation for the Treatment of Acute Stentless Bioprosthetic Aortic Insufficiency and Cardiogenic Shock.

Bioprosthetic aortic valve degeneration may present as acute, severe aortic regurgitation and cardiogenic shock. Such patients may be unsuitable for emergency valve replacement surgery due to excessive risk of operative mortality but could be treatable with transfemoral valve-in-valve transcatheter aortic valve implantation (TAVI). There is a paucity of data regarding the feasibility of valve-in-valve TAVI in patients presenting with cardiogenic shock due to acute aortic insufficiency from stentless bioprosthetic valve degeneration. We present one such case, highlighting the unique aspects of valve-in-valve TAVI for this challenging patient subset.

Prioritizing and Combining Therapies for Heart Failure in the Era of Mechanical Support Devices.

Technological advances have promoted challenges to prioritizing and combining therapies for heart failure. The concept of prioritization implies distinct but inextricably linked considerations. They may be viewed from pathophysiologic, clinical, and procedural perspectives, encompassing analysis of hemodynamic status, anatomic considerations, and technical challenges. It is essential to consider factors, including conduction disease, renal and pulmonary function, hematological derangements, and so forth. These considerations allow determination of clinical goals, which determine prioritization and interventional strategies. These considerations then facilitate goal setting for medical and interventional therapies as definitive/destination, preservation/salvage, stepwise, bridge, or palliation.

Psoas Muscle Area as a Predictor of Outcomes in Transcatheter Aortic Valve Implantation.

Frailty is a powerful predictor of outcomes after transcatheter aortic valve implantation (TAVI). Sarcopenia as assessed by psoas muscle area (PMA) is a validated tool to assess frailty before surgical procedures. We evaluated PMA as a predictor of outcomes after TAVI in 152 consecutive patients who underwent this procedure at our institution from 2011 to 2014. Preoperative computed tomography scans were used to measure PMA, which then was indexed to body surface area. Outcomes evaluated included (1) early poor outcome (30 days mortality, stroke, dialysis, and prolonged ventilation), (2) 1-year mortality, and (3) high-resource utilization (length of stay >7 days, discharge to rehabilitation, or readmission within 30 days). Indexed PMA (odds ratio [OR] 3.19, confidence interval [CI] 1.30 to 7.83; p = 0.012) and age (OR 1.92, CI 1.87 to 1.98; p = 0.012) predicted early poor outcome. Society of Thoracic Surgeons score predicted 1-year mortality (hazard ratio 3.07, CI 1.93 to 6.23; p = 0.011). High-resource utilization was observed more frequently in patients with PMA less than the median (73% vs 51%, OR 2.65, CI 1.32 to 5.36; p = 0.006). In conclusion, indexed PMA predicts early poor outcome and high-resource utilization after TAVI.

Impact of mechanical reperfusion on clinical outcome in elderly patients with right ventricular infarction.

BACKGROUND: Previous reports suggest that elderly patients with acute right ventricular infarction suffer in-hospital mortality of 50% and that hemodynamic compromise is irreversible. We hypothesized that mechanical reperfusion would improve such outcomes. METHODS: We retrospectively analyzed in-hospital morbidity and mortality in 54 patients >70 years of age with acute inferior myocardial infarction undergoing primary angioplasty. The presence of right ventricular infarction was determined by a two dimensional echocardiogram. RESULTS: Overall, 18 (33%) patients had inferior myocardial infarction and right ventricular infarction, whereas 36 (67%) patients had inferior myocardial infarction alone. All patients with inferior myocardial infarction alone were successfully reperfused, whereas one patient with right ventricular infarction suffered reperfusion failure. Right ventricular infarction patients more commonly suffered hemodynamic and arrhythmic complications (hypotension in 33 vs. 2.8%, P<0.01; ventricular arrhythmias in 61 vs. 25%, P<0.01; and bradyarrhythmias in 78 vs. 25%, P<0.01). Overall, 72% of right ventricular infarction patients survived, including many with hemodynamic compromise. In-hospital mortality, however, was greater in those with right ventricular infarction than in those without (28 vs. 8.3%, P=0.19). CONCLUSION: Elderly patients with inferior myocardial infarction complicated by right ventricular infarction suffer greater morbidity and mortality than those without. With successful mechanical reperfusion, however, the majority survives, including those with hemodynamic compromise.

Percutaneous left ventricular assist device in acute myocardial infarction and cardiogenic shock.

Despite advances in coronary angioplasty for acute myocardial infarction (MI), the mortality rate for patients presenting with cardiogenic shock remains high. This case review describes the management of a patient with a non-ST segment elevation MI complicated by cardiogenic shock. The clinical and therapeutic utility of a percutaneous left atrial-to-femoral arterial ventricular assist device is discussed.