Two-Year Follow Up of the LATERAL Clinical Trial: A Focus on Adverse Events.

BACKGROUND: The LATERAL trial validated the safety and efficacy of the thoracotomy approach for implantation of the HeartWare HVAD System, leading to Food and Drug Administration approval. We sought to analyze 24-month adverse event (AE) rates, including a temporal analysis of the risk profile, associated with the thoracotomy approach for the HVAD system. METHODS: AEs from the LATERAL trial were evaluated over 2 years postimplant. Data was obtained from the Interagency Registry for Mechanically Assisted Circulatory Support database for 144 enrolled United States and Canadian patients. Temporal AE profiles were expressed as events per patient year. RESULTS: During 162.5 patient years of support, there were 25 driveline infections (0.15 events per patient year), 50 gastrointestinal bleeds (0.31 events per patient year), and 21 strokes (0.13 events per patient year). Longitudinal AE analysis at follow-up intervals of <30 and 30 to 180 days, and 6 to 12 and 12 to 24 months revealed the highest AE rate at <30 days, with a decrease in total AEs within the first 6 months. After 6 months, most AE rates either stabilized or decreased through 2 years, including a 95% overall freedom from disabling stroke. CONCLUSIONS: Two-year follow-up of the LATERAL trial revealed a favorable morbidity profile in patients supported with the HVAD system, as AE rates were more likely to occur in the first 30 days postimplant, and overall AE rates were significantly reduced after 6 months. Importantly, 2-year freedom from disabling stroke was 95%. These data further support the improving AE profile of patients on long-term HVAD support. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02268942.

Evaluation of an Explanted Tiara Transcatheter Mitral Valve.

Post-explant (ex vivo) evaluation of medical devices is an essential part of quality assurance, quality improvement, and further device development. Central to this is detailed pathological analysis. Here, we provide the first such evaluation of an explanted Tiara transcatheter mitral valve prosthesis. (Level of Difficulty: Advanced.).

The train has left: Can surgeons still get a ticket to treat structural heart disease?

With the disruptive advancement of catheter-based technologies and minimally invasive techniques in structural heart disease, surgeons must obtain necessary skills to continue to serve this large patient population. We believe that surgeons are uniquely positioned to offer the full spectrum of therapy in structural heart disease (transcatheter, minimally invasive, and complex redo interventions), making them comprehensive valve specialists. Given the variability in structural heart training, we urgently recommend the establishment of a standardized curriculum and pathways for surgical trainees to gain proficiency in transcatheter technologies.

Aortic Valve-in-Valve in Externally Mounted Bioprosthesis: A Safe Treatment Option for Bioprosthetic Structural Valve Dysfunction.

OBJECTIVE: Aortic valve-in-valve implantation for prosthetic valve dysfunction is a good alternative to reoperative valve replacement. There are some limitations to this approach including the risk of coronary occlusion, patient prosthesis mismatch, and valve malposition. The incidence of coronary occlusion is higher in aortic valve-in-valve than de novo aortic stenosis cases. Multiple factors can contribute to this complication, and the type of bioprosthesis has been implicated. METHODS: We examined our experience of 80 aortic valve-in-valve cases with internally and externally mounted leaflet valves. RESULTS: Procedural success was achieved in 95% of cases with an overall 30-day mortality of 1.3%. Clinical and procedural outcomes were similar in the both cohorts. CONCLUSIONS: Our data suggest that aortic valve-in-valve implantation can be safely performed in carefully selected patient with internally and externally mounted leaflet bioprosthesis.

HeartWare ventricular assist device as a bridge to heart transplantation in a patient with congenitally corrected transposition of the great arteries and dextrocardia.

Congenitally corrected transposition of the great arteries (ccTGA) is a rare condition with prevalence of <0.5%. Dextrocardia is reported among 20% of them. Among patients with ccTGA, heart failure is a common presentation, especially in the fourth or fifth decade of life and survival is dismal without heart transplantation. A left ventricular assist device (LVAD) is considered for bridge to transplantation if early heart transplantation is not available or as destination therapy for patients ineligible for heart transplant. Our patient had ccTGA and dextrocardia, after which he developed failure of a systemic ventricle and severe systemic atrioventricular valve, subpulmonic atrioventricular valve and aortic valve regurgitation along with paroxysmal atrial fibrillation. A third-generation ventricular assist device HeartWare ventricular assist device (HVAD, HeartWare, Inc., Framingham, MA, USA) was implanted as a bridge to transplantation with concomitant aortic valve replacement with a bioprosthetic valve. There is no prior publication on HVAD implantation in patient having both ccTGA and dextrocardia. Our case report includes the patient's summary and literature review encompassing limited experience of LVADs in patients with ccTGA and dextrocardia.

Short-term mechanical circulatory support for recovery from acute right ventricular failure: clinical outcomes.

BACKGROUND: Acute right ventricular failure (ARVF) refractory to optimal medical management may require rescue therapy with mechanical circulatory support (MCS). The RV exhibits a greater capacity for rapid recovery than the left ventricle, making devices designed specifically for temporary RV MCS attractive. We report our experience with the Impella Right Direct (RD) and Right Peripheral (RP) temporary ventricular assist devices (Abiomed, Danvers, MA) in patients with ARVF. METHODS: We conducted a retrospective cohort study examining the clinical outcomes of consecutive patients supported with the Impella RD or RP at 2 institutions during a 6-year period. RESULTS: During the study period, 18 patients (67% men; mean age 57 ± 10 years) received MCS, 15 with the Impella RD and 3 with the Impella RP. Before RV MCS, all patients required intravenous inotropes, 7 (39%) required inhaled nitric oxide, 7 (39%) required intra-aortic balloon counterpulsation, and 2 (11%) had experienced a cardiac arrest. Device implantation resulted in an improvement in cardiac index (2.1 ± 0.1 liters/min/m(2) pre-implant vs 2.6 ± 0.2 liters/min/m(2) post-implant, p = 0.04) and reduced central venous pressure (22 ± 5 vs 15 ± 4 mm Hg, p < 0.01). Fourteen (78%) patients recovered sufficient RV function to facilitate device explanation after 7 days (range, 2-19 days) of support, and 4 (22%) patients died on support after 6 days (range 1-11 days). Survival to 30 days was 72% and to 1 year was 50%. At 1-year follow-up, the mean New York Heart Association functional classification was 1.3 ± 0.5, and only 1 patient demonstrated severe RV dysfunction on echocardiography. CONCLUSIONS: Most patients with ARVF rapidly recover sufficient RV function to facilitate device explantation, highlighting an expanding role for minimally invasive temporary RV assist devices optimized for the treatment of recoverable ARVF.

Transcatheter transapical mitral valve-in-valve implantations for a failed bioprosthesis: a case series.

OBJECTIVES: Mitral valve replacement with bioprosthetic valves is becoming more common. The incidence of structural valve deterioration and the need for reoperative mitral surgery are expected to increase. The operative mortality and morbidity associated with redo mitral surgery remains high. Transapical transcatheter mitral valve-in-valve implantation might offer an alternate and safer approach for high-risk patients. METHODS: From July 2007 to April 2010, 11 patients with symptomatic mitral prosthetic valve dysfunction underwent transapical transapical transcatheter mitral valve-in-valve implantation in our institution. Data were collected and entered into a database prospectively. The mean age was 81 ± 5 years, with 64% being female. The mean Society of Thoracic Surgeons risk score was 16.1% ± 5.8%. RESULTS: All patients had successful transapical transcatheter mitral valve-in-valve implantation with no 30-day mortality. One patient died 45 days after surgical intervention from respiratory failure, and 1 patient died on day 135. All other patients were alive and in New York Heart Association class I/II at a median follow-up of 357 days. The median postprocedural transvalvular gradient was 7 mm Hg, and minimal transvalvular or paravalvular regurgitation was seen. CONCLUSIONS: Transcatheter transapical valve-in-valve implantations into a failed mitral bioprosthesis is technically feasible with acceptable results. It might be a viable approach for selected high-risk patients.